U.S. patent application number 15/128835 was filed with the patent office on 2017-06-22 for tea composition comprising cyclocarya paliurus and preparation method and uses thereof.
The applicant listed for this patent is INFINITUS (China) Company LTD. Invention is credited to Xiaolei GUO, Zhen LUO, Chung Wah MA, Xia ZHENG.
Application Number | 20170173101 15/128835 |
Document ID | / |
Family ID | 57198132 |
Filed Date | 2017-06-22 |
United States Patent
Application |
20170173101 |
Kind Code |
A1 |
LUO; Zhen ; et al. |
June 22, 2017 |
TEA COMPOSITION COMPRISING CYCLOCARYA PALIURUS AND PREPARATION
METHOD AND USES THEREOF
Abstract
Compositions and preparation method thereof, said compositions
comprise Cyclocarya paliurus leaf and one or more herbs selected
from the group consisting of Green Tea, Mori Folium, Siraitiae
Fructus, Broadleaf Holly leaf and Polygonati odorati Rhizoma, and
their preparation method. Said compositions can treat diabetes,
hyperglycemia, hypertension and/or hyperlipidemia.
Inventors: |
LUO; Zhen; (Guangzhou,
CN) ; ZHENG; Xia; (Guangzhou, CN) ; GUO;
Xiaolei; (Guangzhou, CN) ; MA; Chung Wah;
(Guangzhou, CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
INFINITUS (China) Company LTD |
Jiang Men City, Guangdong |
|
CN |
|
|
Family ID: |
57198132 |
Appl. No.: |
15/128835 |
Filed: |
April 28, 2016 |
PCT Filed: |
April 28, 2016 |
PCT NO: |
PCT/CN2016/080553 |
371 Date: |
September 23, 2016 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 9/4833 20130101;
A61K 9/1652 20130101; A61K 2236/17 20130101; A61K 36/8984 20130101;
H05K 999/99 20130101; A61P 3/06 20180101; A61K 2236/13 20130101;
A61K 9/485 20130101; A23V 2002/00 20130101; A61K 36/605 20130101;
A61K 36/42 20130101; A23L 33/40 20160801; A61K 9/1623 20130101;
A61K 36/82 20130101; A61K 9/4866 20130101; A61K 36/752 20130101;
A61K 36/8969 20130101; B65D 85/808 20130101; A61K 9/4808 20130101;
A61K 36/488 20130101; A61K 36/185 20130101; A61K 2236/51 20130101;
A61K 36/52 20130101; A61P 3/10 20180101; A61K 9/16 20130101; A47G
19/16 20130101; A61K 9/4825 20130101; A61K 2236/00 20130101; A61K
2236/15 20130101; A61K 36/88 20130101; A61P 9/12 20180101; A61K
36/52 20130101; A61K 2300/00 20130101; A61K 36/605 20130101; A61K
2300/00 20130101; A61K 36/752 20130101; A61K 2300/00 20130101; A61K
36/8984 20130101; A61K 2300/00 20130101; A61K 36/42 20130101; A61K
2300/00 20130101; A61K 36/8969 20130101; A61K 2300/00 20130101;
A61K 36/185 20130101; A61K 2300/00 20130101 |
International
Class: |
A61K 36/82 20060101
A61K036/82; A47G 19/16 20060101 A47G019/16; B65D 85/808 20060101
B65D085/808; A61K 36/605 20060101 A61K036/605; A61K 36/52 20060101
A61K036/52 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 29, 2015 |
CN |
201510212607.0 |
Apr 29, 2015 |
CN |
201510213059.3 |
Apr 29, 2015 |
CN |
201510214436.5 |
Claims
1. A health care composition comprising about 20-60% (w) Cyclocarya
paliurus leaves, about 20-60% (w) Green Tea and about 20-60% (w)
Mori Folium.
2-3. (canceled)
4. The health care composition of claim 1, wherein the health care
composition comprises about 30-40% (w) Cyclocarya paliurus leaves,
about 30-40% (w) Green Tea and about 20-40% (w) Mori Folium.
5. The health care composition of claim 1, wherein the health care
composition comprises about 33.3% (w) Cyclocarya paliurus leaves,
about 33.3% (w) Green Tea and about 33.3% (w) Mori Folium.
6-7. (canceled)
8. A method for preparing an herbal tea composition comprising
Cyclocarya paliurus leaves, Mori Folium and Green Tea, wherein the
method comprising mixing crushed and sieved leaves of Cyclocarya
paliurus, Mori Folium and Green Tea in a relative proportion (by
weight) of about 20-60%:20-60%:20-60% respectively, wherein the
crushed leaves are sieved to remove particles that are smaller than
60-mesh in size prior to mixing.
9. The method of claim 8, further comprising separately crushing
leaves of Cyclocarya paliurus, Mori Folium and Green Tea and
sieving the crushed leaves through a 60-mesh to 20-mesh sieve to
remove fine particles prior to mixing.
10. The method of claim 8, further comprising mixing leaves of
Cyclocarya paliurus and Mori Folium to obtain a first mixture,
crushing and sieving the first mixture prior to mixing the crushed
and sieved leaves in the first mixture with the Green Tea.
11. The method of claim 10, further comprising washing and drying
the leaves of Cyclocarya paliurus and Mori Folium to less than
about 10% water content prior to mixing.
12. The method of claim 8, comprising mixing crushed and sieved
leaves of Cyclocarya paliurus, Mori Folium and Green Tea in a
relative proportion (by weight) of about 1:1:1 respectively.
13. The method of claim 8, further comprising packaging at least a
portion of the mixture in a package.
14. The method of claim 8, wherein the method comprises: i)
crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea;
ii) sieving the crushed leaves through a 60-mesh to 20-mesh sieve
to remove fine particles; iii) mixing a portion of the crushed and
sieved leaves of Cyclocarya paliurus, a portion of the crushed and
sieved leaves of Mori Folium, and a portion of the crushed and
sieved leaves of Green Tea; and iv) packaging at least a portion of
the mixture in a package.
15. (canceled)
16. The method of claim 8, wherein the method comprises: i) washing
leaves of Cyclocarya paliurus and Mori Folium; ii) drying the
washed leaves at about 80-100.degree. C. to less than about 10%
water content; iii) crushing the dried leaves to a size of about
0.1 cm to 2 cm; iv) sieving the crushed leaves through an 80-mesh
to 20-mesh sieve to remove fine particles; v) mixing a portion of
the crushed and sieved leaves of Cyclocarya paliurus and Mori
Folium, with a portion of Green Tea; and vi) packaging at least a
portion of the mixture in a package.
17. The method of claim 8, wherein the method comprising: i)
separately crushing leaves of Cyclocarya paliurus, Mori Folium and
Green Tea; ii) separately sieving the crushed leaves through a
60-mesh to 20-mesh sieve to remove fine particles; iii) mixing a
portion of about 500 g of the crushed and sieved leaves of
Cyclocarya paliurus, a portion of about 500 g of the crushed and
sieved leaves of Mori Folium and a portion of about 500 g of the
crushed and sieved leaves of Green Tea for at least 10 minutes to
achieve uniform mixing; iv) dividing the mixture into equal
portions of about 1 g to about 5 g each; v) packing each portion of
about 1 g to about 5 g of the mixture into an inner package; and
vi) packing the packed inner package into an outer package.
18. An herbal tea composition prepared by the method of claim
8.
19. (canceled)
20. An herbal tea composition consisting essentially of crushed and
sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea,
wherein the crushed and sieved leaves of Cyclocarya paliurus, Mori
Folium and Green Tea are in a relative proportion (by weight) of
about 20-60%:20-60%:20-60% respectively.
21. The herbal tea composition of claim 20, wherein the crushed and
sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea are
in a relative proportion (by weight) of about 1:1:1
respectively.
22. An herbal tea bag comprising the herbal tea composition of
claim 20, and a packaging.
23. The herbal tea bag of claim 22, wherein the packaging
comprising an inner package and an outer package.
24. (canceled)
25. A method of lowering blood sugar in a subject in need thereof
comprising administering to the subject a therapeutically effective
amount of the health care composition of claim 1.
26. A method of lowering blood sugar in a subject in need thereof,
comprising administering to the subject a therapeutically effective
amount of the herbal tea composition of claim 18.
27. A method of treating hyperglycemia, hypertension, and/or
hyperlipidemia in a subject in need thereof, comprising
administering to the subject a therapeutically effective amount of
the health care composition of claim 1.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to People's Republic of
China Patent Application No. 201510212607.0 filed Apr. 29, 2015,
People's Republic of China Patent Application No. 201510214436.5
filed Apr. 29, 2015, and People's Republic of China Patent
Application No. 201510213059.3 filed Apr. 29, 2015, the disclosures
of each of which are hereby incorporated herein by reference in
their entireties.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of herbal
medicine and herbal nutritional composition. In particular, the
present invention relates to processed herbal compositions (such as
an herbal tea) comprising Cyclocarya paliurus leaves and other
herbs (such as Mori Folium and Green Tea), and their use in
lowering blood sugar and treating diabetes, hyperglycemia,
hypertension and/or hyperlipidemia.
BACKGROUND
[0003] Herbal teas are widely consumed by people worldwide, and
many cultures have treasured traditions of using herbal teas to
promote health, improve bodily functions, and treat illnesses.
Owing to the rapid changes in people's diet and lifestyle, most
countries today are challenged by epidemics of metabolic
conditions, such as diabetes, cardiovascular diseases,
hypertension, and obesity. However, many of these metabolic
conditions are chronic, and individuals afflicted by the conditions
need lifelong and expensive treatment and special dietary
regimen.
[0004] Particular herbs from Chinese medicine, such as Cyclocarya
paliurus, Mori Folium, and Green Tea, have been empirically and
experimentally proven to help lower blood sugar, which is
beneficial because elevated blood sugar levels can lead to severe
damage to the body. High blood sugar level is also the culprit for
the devastating health effects of many chronic metabolic diseases,
such as diabetes. Therefore, regular consumption of herbal tea
compositions comprising herbs with known potentials to lower blood
sugar can serve as an effective and sustainable strategy to manage
or prevent the long-term metabolic conditions.
[0005] All references described herein are incorporated by
reference in their entirety.
BRIEF SUMMARY OF THE INVENTION
[0006] The present invention provides a health care composition
(such as a pharmaceutical composition or a nutritional composition)
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus leaves and one or more herbs selected from the
group consisting of Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma.
[0007] In some aspects, provided is an herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus leaves and one or more herbs selected from the
group consisting of Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma, and a method
for preparing the herbal tea composition thereof. An herbal tea bag
comprising the herbal tea composition is also provided by the
present invention. The herbal tea composition and the herbal tea
bag are useful for lowering blood sugar, treating diabetes,
hyperglycemia, hypertension, and/or hyperlipidemia in a subject in
need thereof.
[0008] In some embodiments, provided is an herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus leaves, Green Tea and Mori Folium. In some
embodiments, provided is an herbal tea composition comprising
(including consisting essentially of or consisting of) Cyclocarya
paliurus leaves, Siraitiae Fructus, and Mori Folium. In some
embodiments, provided is an herbal tea composition comprising
(including consisting essentially of or consisting of) Cyclocarya
paliurus leaves and Broadleaf Holly leaves. In some embodiments,
provided is an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus
leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma.
[0009] In one aspect, the present invention provides a method for
preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus
leaves, Mori Folium and Green Tea, wherein the method comprises
mixing crushed and sieved leaves of Cyclocarya paliurus, Mori
Folium and Green Tea, wherein the crushed leaves are sieved to
remove particles that are smaller than a certain size (such as
60-mesh) prior to mixing.
[0010] En one embodiment, the relative proportion (by weight) of
the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium
and Green Tea provided in the method for preparing the herbal tea
composition is about 1:1:1, respectively.
[0011] Another aspect of the present invention provides a method
for preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus,
Mori Folium and Green Tea, wherein the method comprises crushing
leaves of Cyclocarya paliurus, Mori Folium and Green Tea; sieving
the crushed leaves through a mesh (such as 60-mesh to 20-mesh)
sieve to remove fine particles; mixing a portion of the crushed and
sieved leaves of Cyclocarya paliurus, a portion of the crushed and
sieved leaves of Mori Folium and a portion of the crushed and
sieved leaves of Green Tea; and packaging at least a portion of the
mixture in a package.
[0012] Another aspect of the present invention provides a method
for preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus,
Mori Folium and Green Tea, wherein the method comprises washing
leaves of Cyclocarya paliurus and Mori Folium; drying the washed
leaves at about 80-100.degree. C. to less than about 10% water
content; crushing the dried leaves to a size of about 0.1 cm to 2
cm; sieving the crushed leaves through a sieve (such as 80-mesh to
20-mesh sieve) to remove fine particles; mixing a portion of the
crushed and sieved leaves of Cyclocarya paliurus and Mori Folium,
with a portion of Green Tea; and packaging at least a portion of
the mixture in a package.
[0013] In some embodiments of the methods described above, equal
portions (by weight) of the crushed and sieved leaves of Cyclocarya
paliurus, Mori Folium and Green Tea are provided to prepare the
herbal tea composition.
[0014] Yet another aspect of the present invention provides a
method for preparing an herbal tea composition comprising
(including consisting essentially of or consisting of) Cyclocarya
paliurus leaves, Mori Folium and Green Tea, wherein the method
comprises separately crushing leaves of Cyclocarya paliurus, Mori
Folium and Green Tea; separately sieving the crushed leaves through
a mesh (such as 60-mesh to 20-mesh) sieve to remove fine particles;
mixing a portion of about 15 times weight (e.g., about 500 g) of
the crushed and sieved leaves of Cyclocarya paliurus, a portion of
about 15 times weight (e.g., about 500 g) of the crushed and sieved
leaves of Mori Folium and a portion of about 15 times weight (e.g.,
about 500 g) of the crushed and sieved leaves of Green Tea for at
least about 10 minutes (such as about 10-30 minutes, or about 20
minutes) to achieve uniform mixing; dividing the mixture into equal
portions (e.g., about 1-5 g each, or about 1.5 g each); packing
each portion (e.g., about 1-5 g each, or about 1.5 g each) of the
mixture into an inner package; and packing the packed inner package
into an outer package.
[0015] Further provided by the present invention is an herbal tea
composition prepared by any of the methods detailed herein.
[0016] Still another aspect of the present invention provides an
herbal tea composition for lowering blood sugar in a subject in
need thereof, comprising Cyclocarya paliurus, Mori Folium and Green
Tea, prepared by a method comprising mixing equal portions (by
weight) of crushed and sieved leaves of Cyclocarya paliurus, Mori
Folium and Green Tea.
[0017] Still yet another aspect of the present invention provides
an herbal tea composition consisting essentially of or consisting
of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium
and Green Tea.
[0018] In one embodiment, the herbal tea composition consists
essentially of or consists of crushed and sieved leaves of
Cyclocarya paliurus, Mori Folium and Green Tea in a relative
proportion (by weight) of about 1-98%:1-98%:1-98%, about
10-80%:10-80%:10-80%, about 20-60%:20-60%:20-60%, about
30-40%:30-40%:20-40%, about 33.3%:33.3%:33.3%, or about 1:1:1
respectively.
[0019] Also provided by the present invention is an herbal tea bag
comprising any of the herbal tea compositions described herein, and
a packaging.
[0020] Further provided is a method for lowering blood sugar or
treating diabetes, hyperglycemia, hypertension, and/or
hyperlipidemia in a subject in need thereof, comprising
administering a therapeutically effective amount of a health care
composition, an herbal tea composition, or an herbal extract
composition detailed herein.
[0021] Also provided is a use of a health care composition, an
herbal tea composition, or an herbal extract composition detailed
herein in the manufacture of a medicament for the treatment of
diabetes, hyperglycemia, hypertension, and/or hyperlipidemia.
[0022] Further provided is a kit comprising a health care
composition, an herbal tea composition, or an herbal extract
composition detailed herein.
BRIEF DESCRIPTION OF THE DRAWING
[0023] FIG. 1 shows the names in Chinese characters for some of the
Chinese herbal medicines described herein.
[0024] FIG. 2 and FIG. 3 show schematic flow charts of exemplary
embodiments of the method for preparing an herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus, Mori Folium and Green Tea.
DETAILED DESCRIPTION
[0025] The present invention provides a health care composition (or
a health-enhancing composition, e.g., a pharmaceutical composition
or a nutritional composition) comprising (including consisting
essentially of or consisting of) Cyclocarya paliurus leaves and one
or more herbs selected from the group consisting of Green Tea, Mori
Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati
odorati Rhizoma. Also provided are methods of using any of the
compositions in lowering blood sugar, treating a disease or
condition (e.g., diabetes, hyperglycemia, hypertension or
hyperlipidemia), or providing nutritional supplement, to an
individual in need thereof. Further provided are methods and
processes for preparing or manufacturing the compositions described
herein.
[0026] As used herein, the singular form "a", "an", and "the"
includes plural references unless indicated otherwise.
[0027] Reference to "about" a value or parameter herein includes
(and describes) embodiments that are directed to that value or
parameter per se. For example, description referring to "about X"
includes description of "X."
[0028] Unless otherwise noted, technical terms are used according
to conventional usage.
[0029] The compositions and methods of the present invention may
comprise, consist of, or consist essentially of the essential
elements and limitations of the invention described herein, as well
as any additional or optional ingredients, components, or
limitations described herein or otherwise useful.
[0030] It is understood that aspects and embodiments of the
invention described herein include "comprising," "consisting of,"
and "consisting essentially of" aspects and embodiments. For
example, for all compositions described herein, and all methods
using or making a composition described herein, the compositions
can either comprise the listed components or steps, or can "consist
essentially of" the listed components or steps. A composition
consisting essentially of a list of components contains at least
70% (e.g., by weight) of the listed components. In some
embodiments, a composition consisting essentially of a list of
components contains at least 75%, 80%, 85%, 90% or 95% (e.g., by
weight) of the listed components. In some embodiments, a
composition consisting essentially of a list of components contains
at least 95%, 96%, 97%, 98% or 99% (e.g., by weight) of the listed
components. In some embodiments, a composition consisting
essentially of a list of components contains about 99%, about 99.5%
or about 99.9% (e.g., by weight) of the listed components. For
example, in a pharmaceutical composition consisting essentially of
a list of herbal components (e.g., Cyclocarya paliurus leaves,
Green Tea and Mori Folium), the listed herbal components account
for at least 70% (e.g., by weight) of all of the active
ingredients. In some embodiments, the pharmaceutical composition
contains at least 85%, 90%, 95%, or 99% (by weight) of list of
herbal components (e.g., Cyclocarya paliurus leaves, Green Tea and
Mori Folium). In some embodiments, the pharmaceutical composition
contains about 99%, about 99.5% or about 99.9% (by weight) of list
of herbal components (e.g., Cyclocarya paliurus leaves, Green Tea
and Mori Folium).
[0031] As used herein, a composition comprising an herb (e.g.,
Cyclocarya paliurus leaves) means the composition includes
(inclusive or open-ended) the herb in its raw form or processed
form, for example, crushed and sieved parts or particles, or
extracts of the herb. When a percentage (or relative amount) of an
herb is stated for a composition obtained by processing a mixture
of more than one herbs, the percentage or relative amount indicates
the proportion of the herb in the mixture before the mixture is
processed. For example, when an herbal extract composition obtained
by extracting a mixture of Cyclocarya paliurus leaves and other
herbs is stated to comprise about 50% (by weight) of Cyclocarya
paliurus leaves, the mixture comprises about 50% (by weight) of
Cyclocarya paliurus leaves before extraction.
[0032] Health Care Compositions
[0033] Cyclocarya paliurus (also known as wheel wingnut, sweet tea
tree, or in Traditional Chinese Medicine Qing qian liu) is a native
deciduous plant of China and the sole species in the genus of
Cyclocarya in the family Juglandaceae. The plant is only found in
China, and its leaves contain a soluble heteropolysaccharide
consisting of various monosaccaride building blocks, among many
other bioactive ingredients, which have experimentally been shown
to increase insulin sensitivity and reduce blood sugar in animal
models. Having a bitter sweet flavor, the leaves of Cyclocarya
paliurus (Qing qian liu ye in Chinese) and their extracts have been
used in Chinese folk medicines and herbal tea compositions for
treating and preventing conditions associated with elevated blood
sugar. In the present invention, the term "Cyclocarya paliurus"
refers to the plant or any part of the plant, including but not
limited to its leaves, bark, stem, root, buds and flowers.
Additionally, the plant parts of Cyclocarya paliurus can be young
or old, fresh or dried, raw or processed. Indications and
properties of Cyclocarya paliurus leaves as a traditional Chinese
medicine include but are not limited to the following: slightly
bitter, pungent, neutral; act to tonify spleen and resolve
dampness, clear heat and soothe viscera, relieve Qi stagnancy in
liver, nourish kidney Yin; effective for relieving obesity due to
non-invigorating spleen, phlegm turbidity, preference in fatty,
sweet, and heavy-taste food, laziness to move, food retention,
liver depression and Qi stagnation.
[0034] Mori Folium (also known as Folium Mori, Morus leaves,
mulberry leaves, or in Traditional Chinese Medicine Sang ye), is
the leaf of an arbor plant Morus alba, or white mulberry, of the
family Moraceae. Morus alba is widely found in silkworm breeding
regions in south China, Japan, and other subtropical regions in the
South East Asia. Mulberry leaves (Mori Folium) commonly used in
Traditional Chinese Medicine are collected after early frost, and
the leaves have little smell, but a bland, slightly bitter and
astringent taste. Among the multitude of bioactive ingredients in
Mori Folium, 1-deoxynojirimycin can inhibit the enzyme
alpha-glucosidase, which breaks down disaccharides into
monosaccharides, thereby reducing intestinal absorption of sugars
and stabilizing sugar levels in the blood. Mori Folium has been
used in Traditional Chinese Medicine in the form of an herbal tea
composition for improving bodily functions. In the present
invention, "Mori Folium" refers to the leaves of Morus alba
harvested from any geological location, or at any time of the year,
young or old, fresh or dried, in raw or processed conditions.
Indications and properties of Mori Folium as a traditional Chinese
medicine include the following: light smell and bland taste,
slightly bitter and astringent; effective in lowering blood
pressure, promoting urination, and lowering blood lipid level;
capable of inhibiting .alpha.-Glucosidase, and competitively block
disaccharide hydrolases such as maltase and sucrase in brush border
of the small intestinal epithelium; capable of lowering blood
sugar.
[0035] Camellia sinensis (also known as tea plant and tea shrub) is
a flowering evergreen shrub or tree of the family Theaceae.
Camellia sinensis is cultivated in many tropical and subtropical
areas of the world characterized by rich and moist growing
conditions. The Chinese variety of the plant has small leaves that
are harvested and processed with various methods to yield different
teas of varying levels of oxidation, such as white tea, green tea,
and oolong tea. In particular, green tea is rich in antioxidants,
such as catechins, which have antibiotic, anti-cancer,
anti-diabetic, and anti-inflammation potentials. Green tea and its
extracts are widely used worldwide in pharmaceutical compositions,
nutritional compositions, cosmetics and beverages to promote
health. "Green Tea" as used herein refers to the leaves of Camellia
sinensis used in green tea production, and the leaves can be raw or
processed, young or old, fresh or dried. Indications and properties
of Green Tea as a traditional Chinese medicine include the
following: effective in refreshing mind, promoting urination,
relieving fatigue, and anti-aging; good for people having too much
high-fat diet, hypertension, experiencing difficulty in urination,
fever and thirst.
[0036] The invention provides a health care composition (or a
health-enhancing composition, e.g., a pharmaceutical composition or
a nutritional composition) comprising (including consisting
essentially of or consisting of) Cyclocarya paliurus leaves and one
or more herbs selected from the group consisting of Green Tea, Mori
Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati
odorati Rhizoma. In some instances, the composition comprises
(including consists essentially of or consists of) parts or
particles obtained by mechanically processing the herbs. For
example, the composition may comprise crushed parts of the herbs
mixed together in packet (e.g., a tea bag). In some instances, the
composition comprises (including consists essentially of or
consists of) substances extracted from Cyclocarya paliurus leaves
and the other herbs, for example, by using a method described
herein for preparing an herbal extract composition. The health care
composition disclosed herein comprising the herbs may provide
synergistic effect in lowering blood sugar, while avoiding
excessive toxicity often associated with long-term usage of
Traditional Chinese Medicine due to factors such as heavy metal
contamination and impurities.
[0037] In some embodiments, the health care composition comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves and one or more herbs selected from the group
consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf
Holly leaves and Polygonati odorati Rhizoma. In some embodiments,
the health care composition comprises (including consists
essentially of or consists of) Cyclocarya paliurus leaves and one
herb selected from the group consisting of Green Tea, Mori Folium,
Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati
Rhizoma. In some embodiments, the health care composition comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves and two herbs selected from the group consisting of
Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves
and Polygonati odorati Rhizoma. In some embodiments, the health
care composition comprises (including consists essentially of or
consists of) Cyclocarya paliurus leaves and three or four herbs
selected from the group consisting of Green Tea, Mori Folium,
Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati
Rhizoma. In some embodiments, the health care composition comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves, Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma.
[0038] In some preferred embodiments, the health care composition
(e.g., a pharmaceutical composition or a nutritional composition)
comprises (including consists essentially of or consists of)
Cyclocarya paliurus leaves, Green Tea, and Mori Folium. In some
embodiments, the composition comprises about 1-98% (w) Cyclocarya
paliurus leaves, about 1-98% (w) Green Tea and about 1-98% (w) Mori
Folium. In some embodiments, the composition comprises about 10-80%
(w) Cyclocarya paliurus leaves, about 10-80% (w) Green Tea and
about 10-80% (w) Mori Folium. In some embodiments, the composition
comprises about 20-60% (w) Cyclocarya paliurus leaves, about 20-60%
(w) Green Tea and about 20-60% (w) Mori Folium. In some
embodiments, the composition comprises about 30-40% (w) Cyclocarya
paliurus leaves, about 30-40% (w) Green Tea and about 20-40% (w)
Mori Folium. In some embodiments, the composition comprises about
33.3% (w) Cyclocarya paliurus leaves, about 33.3% (w) Green Tea and
about 33.3% (w) Mori Folium. In some embodiments, the health care
composition consists essentially of Cyclocarya paliurus leaves,
Green Tea and Mori Folium. In some embodiments, the health care
composition consists of Cyclocarya paliurus leaves, Green Tea and
Mori Folium. In some embodiments, the health care composition
consists of Cyclocarya paliurus leaves, Green Tea and Mori Folium
at relative proportion (by weight) of about 1:1:1, respectively. In
some embodiments, the composition further comprises one or more
herbs selected from the group consisting of Citri Reticulatae
Pericarpium, Dioscoreae Rhizoma, Paeoniae Radix alba, Poria, and
Puerariae lobatae Radix. In some embodiments of any of the
compositions, the composition further comprises one or more herbs
selected from the group consisting of Polygonati odorati Rhizoma,
Lycii Fructus, Polygonati Rhizoma, Laminariae Thallus/Eckloniae
Thallus, Mume Fructus, Dendrobii Caulis, Mori Cortex, Ginseng Radix
et Rhizoma, Notoginseng Radix et Rhizoma, Ligustri lucidi Fructus,
Corni Fructus, Chuanxiong Rhizoma, Atractylodis Rhizoma,
Scrophulariae Radix, Rehmanniae Radix, Angelicae sinensis Radix,
Rhodiolae Crenulatae Radix et Rhizoma, Panacis Quinquefolii Radix,
Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix, Prepared
Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Ginkgo Folium,
Astragali Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum
tataricum, Pumpkin, Konjac, Celery, Corn Stigma, Tremella, Hericium
erinaceus, and Garlic.
[0039] In some embodiments, the health care composition (e.g., a
pharmaceutical composition or a nutritional composition) comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves, Siraitiae Fructus, and Mori Folium. In some
embodiments, the composition comprises about 1-98% (w) Cyclocarya
paliurus leaves, about 1-98% (w) Siraitiae Fructus and about 1-98%
(w) Mori Folium. In some embodiments, the composition comprises
about 10-80% (w) Cyclocarya paliurus leaves, about 10-80% (w)
Siraitiae Fructus and about 10-80% (w) Mori Folium. In some
embodiments, the composition comprises about 20-60% (w) Cyclocarya
paliurus leaves, about 20-60% (w) Siraitiae Fructus and about
20-60% (w) Mori Folium. In some embodiments, the health care
composition consists essentially of Cyclocarya paliurus leaves,
Siraitiae Fructus and Mori Folium. In some embodiments, the health
care composition consists of Cyclocarya paliurus leaves, Siraitiae
Fructus and Mori Folium. In some embodiments, the composition
further comprises one or more herbs selected from the group
consisting of Citri Reticulatae Pericarpium, Dioscoreae Rhizoma,
Paeoniae Radix alba, Poria, and Puerariae lobatae Radix. In some
embodiments of any of the compositions, the composition further
comprises one or more herbs selected from the group consisting of
Polygonati odorati Rhizoma, Lycii Fructus, Polygonati Rhizoma,
Laminariae Thallus/Eckloniae Thallus, Mume Fructus, Dendrobii
Caulis, Mori Cortex, Ginseng Radix et Rhizoma, Notoginseng Radix et
Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong
Rhizoma, Atractylodis Rhizoma, Scrophulariae Radix, Rehmanniae
Radix, Angelicae sinensis Radix, Rhodiolae Crenulatae Radix et
Rhizoma, Panacis Quinquefolii Radix, Aloe, Schisandrae chinensis
Fructus, Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae
Rhizoma, Tribuli Fructus, Ginkgo Folium, Astragali Radix,
Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin,
Konjac, Celery, Corn Stigma, Tremella, Hericium erinaceus, and
Garlic.
[0040] In some embodiments, the health care composition (e.g., a
pharmaceutical composition or a nutritional composition) comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves and Broadleaf Holly leaves. In some embodiments,
the composition comprises about 1-98% (w) Cyclocarya paliurus
leaves and about 1-98% (w) Broadleaf Holly leaves. In some
embodiments, the composition comprises about 10-80% (w) Cyclocarya
paliurus leaves and about 10-80% (w) Broadleaf Holly leaves. In
some embodiments, the composition comprises about 20-60% (w)
Cyclocarya paliurus leaves and about 20-60% (w) Broadleaf Holly
leaves. In some embodiments, the composition comprises about 50%
(w) Cyclocarya paliurus leaves and about 50% (w) Broadleaf Holly
leaves. In some embodiments, the health care composition consists
essentially of Cyclocarya paliurus leaves and Broadleaf Holly
leaves. In some embodiments, the health care composition consists
of Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some
embodiments, the composition further comprises one or more herbs
selected from the group consisting of Mori Folium, Green Tea,
Polygonati odorati Rhizoma, Sweet Potato leaves, and Lycii Folium.
In some embodiments, the composition comprises about 10-90% (w)
Cyclocarya paliurus leaves, about 10-90% (w) Broadleaf Holly leaves
and about 10-90% (w) of one or more herbs selected from the group
consisting of Mori Folium, Green Tea, Polygonati odorati Rhizoma,
Sweet Potato leaves, and Lycii Folium. In some embodiments, the
composition comprises about 20-60% (w) Cyclocarya paliurus leaves,
about 20-60% (w) Broadleaf Holly leaves and about 20-60% (w) of one
or more herbs selected from the group consisting of Mori Folium,
Green Tea, Polygonati odorati Rhizoma, Sweet Potato leaves, and
Lycii Folium. In some embodiments, the composition comprises about
40% (w) Cyclocarya paliurus leaves, about 30% (w) Broadleaf Holly
leaves and about 30% (w) of one or more herbs selected from the
group consisting of Mori Folium, Green Tea, Polygonati odorati
Rhizoma, Sweet Potato leaves, and Lycii Folium. In some
embodiments, the composition comprises Cyclocarya paliurus leaves,
Broadleaf Holly leaves and Mori Folium. In some embodiments, the
composition comprises about 40% (w) Cyclocarya paliurus leaves,
about 30% (w) Broadleaf Holly leaves and about 30% (w) Mori Folium.
In one variation, the Broadleaf Holly in the composition is a small
leaf Broadleaf Holly. In some embodiments of any of the
compositions, the composition further comprises one or more herbs
selected from the group consisting of Buckwheat leaves, Longan
leaves, Myrica rubra leaves, Sweet Potato leaves, Eriobotryae
Folium, Lycii Fructus, Polygonati Rhizoma, Laminariae
Thallus/Eckloniae Thallus, Mume Fructus, Dendrobii Caulis, Mori
Cortex, Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma,
Ligustri lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma,
Atractylodis Rhizoma, Scrophulariae Radix, Rehmanniae Radix,
Angelicae sinensis Radix, Rhodiolae Crenulatae Radix et Rhizoma,
Panacis Quinquefolii Radix, Aloe, Schisandrae chinensis Fructus,
Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli
Fructus, Ginkgo Folium, Astragali Radix, Gynostemma pentaphyllum,
Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac, Celery, Corn
Stigma, Tremella, Hericium erinaceus, and Garlic.
[0041] In some embodiments, the health care composition (e.g., a
pharmaceutical composition or a nutritional composition) comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati
Rhizoma. In some embodiments, the composition comprises about 5-85%
(w) Cyclocarya paliurus leaves, about 5-85% (w) Mori Folium, about
5-85% (w) Green Tea, and about 10-85% (w) Polygonati odorati
Rhizoma. In some embodiments, the composition comprises about
10-70% (w) Cyclocarya paliurus leaves, about 10-70% (w) Mori
Folium, about 10-70% (w) Green Tea, and about 10-70% (w) Polygonati
odorati Rhizoma. In some embodiments, the composition comprises
about 20-40% (w) Cyclocarya paliurus leaves, about 20-40% (w) Mori
Folium, about 20-40% (w) Green Tea, and about 20-40% (w) Polygonati
odorati Rhizoma. In some embodiments, the composition comprises
about 30% (w) Cyclocarya paliurus leaves, about 25% (w) Mori
Folium, about 25% (w) Green Tea, and about 20% Polygonati odorati
Rhizoma. In some embodiments, the health care composition consists
essentially of Cyclocarya paliurus leaves, Mori Folium, Green Tea,
and Polygonati odorati Rhizoma. In some embodiments, the health
care composition consists of Cyclocarya paliurus leaves, Mori
Folium, Green Tea, and Polygonati odorati Rhizoma. In some
embodiments, the health care composition consists of Cyclocarya
paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati
Rhizoma at relative proportion (by weight) of about
30%:25%:25%:20%, respectively. In some embodiments, the composition
further comprises one or more herbs selected from the group
consisting of Broadleaf Holly leaves, Black Tea, Lycii Folium,
Buckwheat leaves, Longan leaves, Myrica rubra leaves, Sweet Potato
leaves, and Eriobotryae Folium. In some embodiments, the
composition further comprises one or more herbs selected from the
group consisting of Citri Reticulatae Pericarpium, Dioscoreae
Rhizoma, Scrophulariae Radix, Panacis Quinquefolii Radix, Ginkgo
Folium, Gynostemma pentaphyllum, and Corn Stigma. In some
embodiments of any of the compositions, the composition further
comprises one or more herbs selected from the group consisting of
Polygonati Rhizoma, Laminariae Thallus/Eckloniae Thallus, Siraitiae
Fructus, Mume Fructus, Notoginseng Radix et Rhizoma, Ligustri
lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma, Atractylodis
Rhizoma, Rehmanniae Radix, Paeoniae Radix alba, Aloe, Schisandrae
chinensis Fructus, Ophiopogonis Radix, Prepared Rhubarb,
Anemarrhenae Rhizoma, Tribuli Fructus, Astragali Radix, Gynostemma
pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac,
Celery, Tremella, Hericium erinaceus, and Garlic.
[0042] In some embodiments, the health care composition (e.g., a
pharmaceutical composition or a nutritional composition) comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves, Mori Folium, Green Tea, Polygonati odorati
Rhizoma, and Broadleaf Holly leaves. In some embodiments, the
composition comprises about 20-30% (w) Cyclocarya paliurus leaves,
about 20-70% (w) Mori Folium, about 15-25% (w) Green Tea, about
5-15% (w) Polygonati odorati Rhizoma, and about 5-15% (w) Broadleaf
Holly leaves. In some embodiments, the composition consists
essentially of about 20-30% (w) Cyclocarya paliurus leaves, about
20-70% (w) Mori Folium, about 15-25% (w) Green Tea, about 5-15% (w)
Polygonati odorati Rhizoma, and about 5-15% (w) Broadleaf Holly
leaves. In some embodiments, the health care composition comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves, Broadleaf Holly leaves, Mori Folium, Black Tea,
Polygonati odorati Rhizoma, Green Tea, Eriobotryae Folium,
Buckwheat leaves, and Longan leaves. In some embodiments, the
composition comprises about 20-30% (w) Cyclocarya paliurus leaves,
about 10-20% (w) Broadleaf Holly leaves, about 10-20% (w) Mori
Folium, about 10-20% (w) Black Tea, about 10-20% (w) Polygonati
odorati Rhizoma, about 10-20% (w) Green Tea, about 10-20% (w)
Eriobotryae Folium, about 10-20% (w) Buckwheat leaves, and about
10-20% (w) Longan leaves. In some embodiments, the composition
consists essentially of about 20-30% (w) Cyclocarya paliurus
leaves, about 10-20% (w) Broadleaf Holly leaves, about 10-20% (w)
Mori Folium, about 10-20% (w) Black Tea, about 10-20% (w)
Polygonati odorati Rhizoma, about 10-20% (w) Green Tea, about
10-20% (w) Eriobotryae Folium, about 10-20% (w) Buckwheat leaves
and about 10-20% (w) Longan leaves. In some embodiments, the health
care composition (e.g., a pharmaceutical composition or a
nutritional composition) comprises (including consists essentially
of or consists of) Cyclocarya paliurus leaves, Green Tea, Citri
Reticulatae Pericarpium, Dioscoreae Rhizoma, Black Tea,
Scrophulariae Radix, Panacis Quinquefolii Radix, Ginkgo Folium,
Gynostemma pentaphyllum, and Corn Stigma. In some embodiments, the
composition comprises (including consists essentially of or
consists of) about 10-20% (w) Cyclocarya paliurus leaves, about
5-20% (w) Green Tea, about 5-20% (w) Citri Reticulatae Pericarpium,
about 5-20% (w) Dioscoreae Rhizoma, about 5-20% (w) Black Tea,
about 5-20% (w) Scrophulariae Radix, about 5-20% (w) Panacis
Quinquefolii Radix, about 5-20% (w) Ginkgo Folium, about 5-20% (w)
Gynostemma pentaphyllum, and about 5-20% (w) Corn Stigma. In some
embodiments, the composition consists essentially of about 10% (w)
Cyclocarya paliurus leaves, about 10% (w) Green Tea, about 10% (w)
Citri Reticulatae Pericarpium, about 10% (w) Dioscoreae Rhizoma,
about 10% (w) Black Tea, about 10% (w) Scrophulariae Radix, about
10% (w) Panacis Quinquefolii Radix, about 10% (w) Ginkgo Folium,
about 10% (w) Gynostemma pentaphyllum, and about 10% (w) Corn
Stigma. In some embodiments, the health care composition (e.g., a
pharmaceutical composition or a nutritional composition) comprises
(including consists essentially of or consists of) Cyclocarya
paliurus leaves, Mori Folium, and Polygonati odorati Rhizoma. In
some embodiments of any of the compositions, the composition
further comprises one or more herbs selected from the group
consisting of Polygonati Rhizoma, Laminariae Thallus/Eckloniae
Thallus, Siraitiae Fructus, Mume Fructus, Notoginseng Radix et
Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong
Rhizoma, Atractylodis Rhizoma, Rehmanniae Radix, Paeoniae Radix
alba, Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix,
Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Astragali
Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum,
Pumpkin, Konjac, Celery, Tremella, Hericium erinaceus, and
Garlic.
[0043] The health care composition may be an oral formulation such
as a tablet, a capsule, a granule, a powder, an effervescent
tablet, or an herbal tea formulation. The health care composition
(such as a pharmaceutical composition or a nutritional composition)
may further comprise one or more excipients. Examples of
pharmaceutically acceptable excipient include but are not limited
to pregelatinized starch, .beta.-cyclodextrin, maltodextrin,
Carbopol, microcrystalline cellulose, hydroxypropylmethylcellulose,
low-substituted hydroxypropylcellulose, polyethylene glycol (PEG),
sodium carboxymethyl cellulose, methylcellulose, ethylcellulose,
mannitol, cross-linked sodium carboxymethyl cellulose, lactose,
polyvinylpyrrolidone (PVP), magnesium stearate, talc, silica
powder, aspartame, sodium bicarbonate, and sodium carbonate.
[0044] The health care compositions comprising the herbs (e.g., a
Chinese herbal medicine) described herein may be prepared by
methods known in the art, and methods described herein. For
example, an herbal tea composition comprising one or more of the
herbs described herein can be prepared by crushing and sieving the
herbs, and packaging in a packet (e.g., a tea bag). A granule
composition can be prepared by extracting the herbs with a solvent
(e.g., hot water) and converting the extracts into granules by
using auxiliary agents or excipients such as .beta.-cyclodextrin,
microcrystalline cellulose, calcium hydrogen phosphate, or
mannitol. A gel capsule composition can be manufactured by
enclosure of a granule composition in a gel capsule. An herbal
extract composition can be prepared by extracting the herbs, and
removing impurities, for example, by filtration and centrifugation.
Powders, oral tablets and effervescent tablets can be prepared
using the herbal extracts and appropriate auxiliary materials by
processes known in the art.
[0045] In some embodiments of any of the compositions detailed
herein comprising Green Tea, the Green Tea may be substituted with
Black Tea. In some embodiments, the Green Tea may be substituted
with Siraitiae Fructus.
[0046] Herbal Tea Compositions
[0047] In one aspect, the present invention provides an herbal tea
composition containing Cyclocarya paliurus leaves and other herbal
components, for example, Mori Folium, and Green Tea. Both
Cyclocarya paliurus leaves and Mori Folium have been treasured as
herbal medicines in China since ancient times, and each herb has
been used in Traditional Chinese Medicine to treat and prevent high
blood sugar levels and diabetes. Camellia sinesis, in the form of
Green Tea, gains widespread popularity as a healthy beverage
worldwide. The herbal tea composition disclosed herein may enable
balanced delivery of biologically active substances from each herb,
including polysaccharides, amino acids, vitamins, minerals,
antioxidants and fibers, which are useful for lowering blood sugar
and providing nutritional supplements to human consumers. Many
herbal tea compositions on the market or disclosed by the prior
arts comprise other herbs or additive ingredients, which may
contain substances that interact with the beneficial active
substances in Cyclocarya paliurus leaves, Mori Folium, and Green
Tea, thereby undermining the overall efficacy of some herbal tea
compositions comprising ingredients other than Cyclocarya paliurus
leaves, Mori Folium, and Green Tea. The additional components in
some previous herbal tea compositions may also contain toxic
substances or substances that can cause undesirable side effects
over long-term usage. Also, some methods for preparing similar
herbal tea compositions in prior arts involve steps that can
disrupt the integrity of the bioactive ingredients in the herbs.
The method for preparing the herbal tea composition in the present
invention can preserve the active ingredients from the herbs that
are useful for reducing blood sugar. The herbal tea composition
described herein provides consumers a simple-to-use,
cost-effective, and flavorful means for long-term management of
their blood sugar and for maintenance of their health.
[0048] In some embodiments, provided is an herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus leaves and one or more herbs selected from the
group consisting of Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some
embodiments, the herbal tea composition comprises (including
consists essentially of or consists of) Cyclocarya paliurus leaves
and one, two, or three herbs selected from the group consisting of
Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves
and Polygonati odorati Rhizoma. In some embodiments, the herbal tea
composition consists essentially of Cyclocarya paliurus leaves and
one, two, or three herbs selected from the group consisting of
Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves
and Polygonati odorati Rhizoma. In some embodiments, the herbal tea
composition further comprises one or more of additional herbs
describe herein, for example, herbs described for any of the health
care compositions detailed herein.
[0049] Herbal tea compositions comprising (including consisting
essentially of or consisting of) each and every combinations of
herbs detailed herein for the health care compositions are embraced
and described as if each and every combinations are explicitly
recited. For example, in some embodiments, provided is an herbal
tea composition comprising (including consisting essentially of or
consisting of) Cyclocarya paliurus leaves, Siraitiae Fructus, and
Mori Folium. In some embodiments, provided is an herbal tea
composition comprising (including consisting essentially of or
consisting of) Cyclocarya paliurus leaves and Broadleaf Holly
leaves. In some embodiments, provided is an herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati
odorati Rhizoma.
[0050] In a preferred embodiment, provided is an herbal tea
composition comprising (including consisting essentially of or
consisting of) Cyclocarya paliurus, Mori Folium and Green Tea,
prepared by a method comprising mixing of crushed and sieved leaves
of Cyclocarya paliurus, Mori Folium and Green Tea. One aspect of
the present invention provides an herbal tea composition consisting
essentially of or consisting of crushed and sieved leaves of
Cyclocarya paliurus, Mori Folium and Green Tea. The herbal tea
compositions described herein are useful for lowering blood sugar
in a subject in need thereof.
[0051] The relative proportion of Cyclocarya paliurus and other
herbs (e.g., Mori Folium and Green Tea) in the herbal tea
composition can be important for achieving optimal health benefits.
In one embodiment, specifically provided is an herbal tea
composition prepared by a method comprising mixing equal portions
(by weight) of crushed and sieved leaves of Cyclocarya paliurus,
Mori Folium and Green Tea. Accordingly, the ratio by weight of the
crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and
Green Tea in the herbal tea composition is about 1:1:1
respectively.
[0052] The present invention further provides an herbal tea
composition consisting essentially of or consisting of crushed and
sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea. In
one embodiment, the herbal tea composition consists essentially of
or consists of crushed and sieves leaves of Cyclocarya paliurus,
Mori Folium and Green Tea in a relative proportion (by weight) of
about 1:1:1 respectively. Accordingly, in this embodiment, the
percentage by weight of Cyclocarya paliurus in the herbal tea
composition is about 33.3%, the percentage by weight of Mori Folium
in the herbal tea composition is about 33.3%, and the percentage by
weight of Green Tea in the herbal tea composition is about
33.3%.
[0053] Any of the herbal tea compositions described herein can
further be incorporated in an herbal tea bag, wherein the herbal
tea bag comprises the herbal tea composition and a packaging. In
one embodiment of the herbal tea bag, the packaging comprises an
inner package and an outer package. The inner package can be a
sterile package of one layer, two layers or more than two layers of
bags made of suitable materials, such as nylon, paper, plastic or
composite materials, which can be used in food production. The
outer package can be a package made of suitable materials, such as
paper, nylon, plastic, metal or composite materials, which can help
to preserve the integrity and flavor of the tea bag.
[0054] The herbal tea composition and the herbal tea bag disclosed
herein are characterized by a low level of heavy metal contents and
other toxic elements. Common heavy metals found in herbal tea
compositions include manganese, copper, cadmium, lead, iron,
mercury, zinc and arsenic. In some embodiments, the herbal tea
composition and the herbal tea bag detailed herein each contains a
total of about less than 20 ppm (parts per million), less than 15
ppm, less than 10 ppm, less than 5 ppm, less than 1 ppm, or less
than 0.5 ppm of combined heavy metal content. In some embodiments,
the herbal tea composition and the herbal tea bag detailed herein
each contains about less than 5 ppm, less than 2 ppm, less than 1
ppm, less than 0.5 ppm, or less than 0.1 ppm of lead; and/or about
less than 3 ppm, less than 2 ppm, less than 1 ppm, less than 0.5
ppm, or less than 0.1 ppm of arsenic; and/or about less than 3 ppm,
less than 2 ppm, less than 1 ppm, less than 0.5 ppm, or less than
0.1 ppm of mercury. The low level of heavy metals ensures safety
for long-term human consumption of the herbal tea composition and
the herbal tea bag.
[0055] Method for Preparation
[0056] The present invention provides a method for preparing an
herbal tea composition comprising herbal combinations detailed
herein, the method comprising crushing and sieving the herbs. In
some embodiments, provided is a method for preparing an herbal tea
composition comprising Cyclocarya paliurus leaves and one or more
herbs selected from the group consisting of Green Tea, Mori Folium,
Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati
Rhizoma, the method comprising crushing and sieving leaves of
Cyclocarya paliurus and the one or more herbs selected from the
group consisting of Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some
embodiments, the method further comprises separately crushing
leaves of Cyclocarya paliurus and the one or more herbs selected
from the group consisting of Green Tea, Mori Folium, Siraitiae
Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma, and
sieving the crushed the leaves through a sieve to remove fine
particles prior to mixing. In some embodiments, the method further
comprises washing and drying (such as separately washing and
drying) the leaves of Cyclocarya paliurus and the one or more herbs
selected from the group consisting of Green Tea, Mori Folium,
Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati
Rhizoma to less than about 10% water content prior to mixing.
[0057] In some embodiments, provided is a method for preparing an
herbal tea composition comprising (including consisting essentially
of or consisting of) Cyclocarya paliurus, Mori Folium and Green
Tea, wherein the method comprises sieving crushed leaves of
Cyclocarya paliurus, Mori Folium and Green Tea through a sieve, and
mixing the sieved and crushed leaves. In one embodiment, the method
further comprises separately crushing leaves of Cyclocarya
paliurus, Mori Folium and Green Tea and sieving the crushed the
leaves through a sieve to remove fine particles prior to
mixing.
[0058] The sieve used in the sieving step can be a mesh-sieve of
appropriate pore size, such as a 20-mesh (about 0.841 mm pore
size), 24-mesh (about 0.707 mm pore size), 28-mesh (about 0.595 mm
pore size), 32-mesh (about 0.5 mm pore size), 35-mesh (about 0.420
mm pore size), 42-mesh (about 0.354 mm pore size), 48-mesh (0.297
mm pore size), 50-mesh (about 0.297 mm pore size), 65-mesh (0.250
mm pore size), 70 mesh (about 0.21 mm pore size), or 80-mesh (about
0.177 mm pore size) sieve. In some embodiments, an about 80-mesh to
about 20-mesh, such as about 60-mesh to about 20-mesh sieve is used
to sieve the crushed leaves. Fine particles smaller than the pore
size of the sieve are discarded to remove undesirable substances
from the herbal tea composition, including particles containing
heavy metals.
[0059] Small amount of heavy metals can normally be found in herbal
tea compositions and herbal tea compositions, which can lead to
toxicity and undesirable side effects, especially for long term
consumption. The heavy metal contents in the crude herbs (i.e.
Cyclocarya paliurus leaves, Mori Folium, and Green Tea) that are
used to prepare the herbal tea composition can vary significantly
depending on their origins of production, thereby affecting the
overall heavy metal contents of the herbal tea commotion and its
derivate products (e.g. the herbal tea bag). Table 1 lists
representative concentrations of lead and arsenic as measured using
methods known in the art in crude Cyclocarya paliurus leaves from
various origins where the herbs are harvested and optionally
processed prior to their use in producing the herbal extract
composition. To warrant a desirable heavy metal content, in some
embodiments of the method for preparing the herbal tea composition,
Cyclocarya paliurus leaves, and the one or more herbs selected from
the group consisting of Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma from origins
that are associated with a low total heavy metal concentration, or
low concentrations of particular heavy metals (such as lead and/or
arsenic) are selected. In some embodiments, the leaves of
Cyclocarya paliurus, and the one or more herbs selected from the
group consisting of Green Tea, Mori Folium, Siraitiae Fructus,
Broadleaf Holly leaves and Polygonati odorati Rhizoma are washed
and dried prior to mixing to reduce the heavy metal contents. A low
total heavy metal concentration can be less than about 10 ppm, less
than about 5 ppm, less than about 1 ppm, or less than about 0.5
ppm. A low concentration of a particular heavy metal (such as lead
or arsenic) can be less than about 10 ppm, less than about 5 ppm,
or less than about 1 ppm, or less than about 0.5 ppm.
TABLE-US-00001 TABLE 1 Heavy metal contents in exemplary Cyclocarya
paliurus leaves from different origins Lead Arsenic Crude herb
Origin (ppm) (ppm) Cyclocarya paliurus Sui Ning, Hunan Province 1.1
0.17 leaves Shi En, Hubei Province 1.4 0.15 Zhang Jia Jie, Hunan
1.8 0.16 Province Huang Ao Xiang, Jiangxi 1.7 <0.5 Province Guan
Shan, Jiangxi 3.7 0.33 Province Da Lian Shan, Jiangxi 2.3 0.27
Province
[0060] The relative ratio of the herbal components (e.g.,
Cyclocarya paliurus, Mori Folium and Green Tea) in the herbal tea
composition is important for achieving optimum health benefits and
flavor. In some embodiments, the method further comprises weighing
the crushed and sieved leaves of the herbs (e.g., Cyclocarya
paliurus, Mori Folium and Green Tea) prior to mixing.
[0061] For an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus
leaves, Mori Folium and Green Tea, the relative ratio by weight of
Cyclocarya paliurus leaves to Mori Folium can be about 1:4 to about
1:3, about 1:3 to about 1:2, about 1:3 to about 1:1, about 1:1 to
about 2:1, about 2:1 to about 3:1, about 3:1 to about 4:1, about
0.8:1 to about 1.2:1, or preferably about 1:1. The relative ratio
by weight of Cyclocarya paliurus leaves to Green Tea can be about
1:4 to about 1:3, about 1:3 to about 1:2, about 1:3 to about 1:1,
about 1:1 to about 2:1, about 2:1 to about 3:1, about 3:1 to about
4:1, about 0.8:1 to about 1.2:1, or preferably about 1:1. In one
preferred embodiment, the relative proportion of the crushed and
sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea
used to prepare the herbal tea composition is about 1:1:1
respectively. The percentage by weight of Cyclocarya paliurus
leaves in the herbal tea composition can be about 1%-10%, 5%-15%,
10%-20%, 15%-25%, 20%-30%, 25%-35%, 30%-40%, 35%-40%, 40%-50%,
45%-55%, 50%-60%, 55%-65%, 60%-70%, 65%-75%, 70%-80%, 75-85%,
80%-90%, 85%-95%, 90-95%, 1%-40%, 40%-70%, 70%-95%, 30%-36%, or
preferably about 33.3%. The percentage by weight of Mori Folium in
the herbal tea composition can be 1%-10%, 5%-15%, 10%-20%, 15%-25%,
20%-30%, 25%-35%, 30%-40%, 35%-40%, 40%-50%, 45%-55%, 50%-60%,
55%-65%, 60%-70%, 65%-75%, 70%-80%, 75-85%, 80%-90%, 85%-95%,
90-95%, 1%-40%, 40%-70%, 70%-95%, 30%-36%, or preferably about
33.3%. The percentage by weight of Green Tea in the herbal tea
composition can be 1%-10%, 5%-15%, 10%-20%, 15%-25%, 20%-30%,
25%-35%, 30%-40%, 35%-40%, 40%-50%, 45%-55%, 50%-60%, 55%-65%,
60%-70%, 65%-75%, 70%-80%, 75-85%, 80%-90%, 85%-95%, 90-95%,
1%-40%, 40%-70%, 70%-95%, 30%-36%, or preferably about 33.3%. In
another preferred embodiment, in the mixture of the crushed and
sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea,
the percentage by weight of Cyclocarya paliurus leaves is about
33.3%, the percentage by weight of Mori Folium is about 33.3%, and
the percentage by weight of Green Tea is about 33.3%.
[0062] The mixing step of the method detailed herein can comprise
mixing the crushed and sieved leaves of Cyclocarya paliurus, Mori
Folium and Green Tea for at least about any of 10 minutes, 20
minutes, 30 minutes, 40 minutes, or 1 hour, in order to obtain a
uniform mixture of the leaves. In one preferred embodiment, the
crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and
Green Tea are mixed for about 10 minutes to about 30 minutes, such
as about 20 minutes. The leaves of Cyclocarya paliurus, Mori Folium
and Green Tea can be crushed separately, or they can be crushed
together. The size of the crushed leaves is about no more than any
of 5 cm, 4 cm, 3 cm, 2 cm, 1.5 cm, 1 cm, 0.5 cm, 0.2 cm, or 0.1 cm.
In some embodiments, the crushed leaves have a size of about 0.1 cm
to about 2 cm. In some embodiments, the Green Tea is processed
Green Tea having a size of about 0.1 cm to about 2 cm.
[0063] The leaves of Cyclocarya paliurus, Mori Folium and Green Tea
can be mixed together, or the leaves of Cyclocarya paliurus and
Mori Folium can be mixed together first, and then mixed with the
Green Tea, such as processed Green Tea. In some embodiments, the
method comprises mixing leaves of Cyclocarya paliurus and Mori
Folium to obtain a first mixture, crushing and sieving the first
mixture, and mixing the crushed and sieved leaves of the first
mixture with the Green Tea (such as processed Green Tea). In some
embodiments, the leaves of Cyclocarya paliurus and Mori Folium are
first washed and dried (such as at a temperature of about
80.degree. C. to about 100.degree. C.) to less than about 10% water
content, crushed to a size of 0.1-2 cm, and sieved through a sieve
(such as about 80-mesh to about 20-mesh) to remove fine particles
prior to mixing with the Green Tea.
[0064] Additional steps can be added to the method to further
enhance the preparation of the herbal tea composition. In some
embodiments, the method further comprises testing the mixture for
quality control. In some embodiments, the method further comprises
packaging at least a portion of the mixture in a package. A portion
of about 1-2 g, 0.5-1.5 g, 2-3 g, 1.5-2.5 g, 3-5 g, 1-5 g, or 5-10
g of the mixture can be packed in a package. In one preferred
embodiment, a portion of about 1-5 g of the mixture is packed in a
package. In another preferred embodiment, a portion of about 1.5 g
of the mixture is packed in a package. The package can be a sterile
package of one layer, two layers or more than two layers made of
suitable materials, such as nylon, paper, plastic or composite
materials, which can be used in food production.
[0065] Another aspect of the present invention provides a method
for preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus
leaves and one or more herbs selected from the group consisting of
Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves
and Polygonati odorati Rhizoma, wherein the method comprises
crushing leaves of Cyclocarya paliurus and the one or more herbs
selected from the group consisting of Green Tea, Mori Folium,
Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati
Rhizoma; sieving the crushed herbs or leaves through a mesh (such
as 60-mesh to about 20-mesh) sieve to remove fine particles; mixing
a portion of the crushed and sieved leaves of Cyclocarya paliurus,
a portion of the crushed and sieved herbs or leaves of each of the
one or more herbs selected from the group consisting of Green Tea,
Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and
Polygonati odorati Rhizoma; and packaging at least a portion of the
mixture in a package.
[0066] In one aspect, the present invention provides a method for
preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus,
Mori Folium and Green Tea, wherein the method comprises crushing
leaves of Cyclocarya paliurus, Mori Folium and Green Tea; sieving
the crushed leaves through a mesh (such as 60-mesh to 20-mesh)
sieve to remove fine particles; mixing a portion of the crushed and
sieved leaves of Cyclocarya paliurus, a portion of the crushed and
sieved leaves of Mori Folium and a portion of the crushed and
sieved leaves of Green Tea; and packaging at least a portion of the
mixture in a package.
[0067] In one aspect, the present invention provides a method for
preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus,
Mori Folium and Green Tea, wherein the method comprises mixing
leaves of Cyclocarya paliurus and Mori Folium to obtain a first
mixture; crushing the mixed leaves (such as to a size of about 0.1
cm to 2 cm), sieving the crushed leaves through a mesh (such as
80-mesh to 20-mesh) sieve to remove fine particles; and mixing a
portion of the crushed and sieved leaves of the first mixture, with
a portion of the Green Tea; and packaging at least a portion of the
mixture in a package.
[0068] In some embodiments, there is provided a method for
preparing an herbal tea composition comprising (including
consisting essentially of or consisting of) Cyclocarya paliurus,
Mori Folium and Green Tea, wherein the method comprises washing
leaves of Cyclocarya paliurus and Mori Folium; drying the washed
leaves (such as at about 80-100.degree. C.) to less than about 10%
water content; crushing the dried leaves (such as to a size of
about 0.1 cm to 2 cm); sieving the crushed leaves through a mesh
(such as 80-mesh to 20-mesh) sieve to remove fine particles; mixing
a portion of the crushed and sieved leaves of Cyclocarya paliurus
and Mori Folium, with a portion of Green Tea; and packaging at
least a portion of the mixture in a package. FIG. 3 illustrates
this exemplary embodiment.
[0069] It is intended that any of the steps and parameters
described herein for preparing the herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus, Mori Folium and Green Tea can be combined with
any of the steps and parameters described herein for preparing the
herbal tea bag, as if each and every combination is individually
described. For example, one exemplary embodiment of the present
invention provides a method for preparing an herbal tea composition
comprising (including consisting essentially of or consisting of)
Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method
comprises separately crushing leaves of Cyclocarya paliurus, Mori
Folium and Green Tea; separately sieving the crushed leaves through
a 60-mesh to 20-mesh sieve to remove fine particles; mixing a
portion of about 500 parts weight (e.g. about 500 grams) of the
crushed and sieved leaves of Cyclocarya paliurus, a portion of
about 500 parts weight (e.g. about 500 grams) of the crushed and
sieved leaves of Mori Folium, and a portion of about 500 parts by
weight (e.g. about 500 grams) of the crushed and sieved leaves of
Green Tea for at least about 10 (such as about 10-30, or about 20)
minutes to achieve uniform mixing; dividing the mixture into equal
portions of about 1-5 times weight (e.g. about 1-5 g, or about 1.5
grams) each; packing each portion of the mixture into an inner
package; and packing the packed inner package into an outer
package. Example 1 illustrates this exemplary method.
[0070] Further provided by the present invention is an herbal tea
composition prepared by any embodiment of the method detailed
herein.
[0071] The herbal tea composition and the herbal tea bag provided
by the present invention can be used by individuals in need of
lowering their blood sugar, for example, those with elevated blood
sugar levels, and diabetic patients. Blood sugar refers to the
variety of naturally occurring carbohydrates, including
monosaccharides, oligosaccharides, and polysaccharides that are
normally found in the blood stream, blood or any serological
fraction of the blood, such as serum. One monosaccharide species,
glucose, is the primary source of energy for cells in all
organisms, and therefore, glucose is one of the most abundant and
highly regulated sugars in the blood. The herbal tea composition
and the herbal tea bag are intended for consumption as a supplement
to the normal treatment and dietary regimen of the subjects in
need. A recommended serving for the herbal tea composition in
packets of about 1.5 g portions is to consume 2 packets per day as
a drink or beverage to maintain or lower blood sugar level in a
subject in need. Consumers may choose other serving regimens
depending on their needs. When packets of larger portions of the
herbal tea composition are used, consumers can adjust their serving
regimen accordingly. Efficacy of the herbal tea composition and the
herbal tea bag can be measured by monitoring a subject's blood
glucose level using any of the currently available assays on the
market over the course of consumption. Comparison of blood sugar
data from a group of subjects (human or animal models) taking the
herbal tea composition versus blood sugar data from a group of
subjects (human or animal models) taking placebo drinks can help
evaluate the efficacy of the herbal tea composition, the herbal tea
or the herbal tea bag.
[0072] Herbal Extract Compositions and Methods of Making
Thereof
[0073] The invention further provides an herbal extract composition
comprising (including consisting essentially of or consisting of)
an extract from any combinations of herbs detailed herein, for
example, an extract from Cyclocarya paliurus leaves and one or more
herbs selected from the group consisting of Green Tea, Mori Folium,
Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati
Rhizoma. In some embodiments, the herbal extract composition
comprises (including consists essentially of or consists of) an
extract from Cyclocarya paliurus leaves, Mori Folium and Green
Tea.
[0074] Herbal extract compositions comprising (including consisting
essentially of or consisting of) an extract of each and every
combinations of herbs detailed herein for the health care
compositions are embraced and described as if each and every
combinations are explicitly recited. For example, in some
embodiments, provided is an herbal extract composition comprising
(including consisting essentially of or consisting of) an extract
of Cyclocarya paliurus leaves, Siraitiae Fructus, and Mori Folium.
In some embodiments, provided is an herbal extract composition
comprising (including consisting essentially of or consisting of)
an extract of Cyclocarya paliurus leaves and Broadleaf Holly
leaves. In some embodiments, provided is an herbal extract
composition comprising (including consisting essentially of or
consisting of) an extract of Cyclocarya paliurus leaves, Mori
Folium, Green Tea, and Polygonati odorati Rhizoma.
[0075] The herbal extract compositions can be prepared by
extracting a mixture of the herbal components, concentrating the
extract, and drying. The herbal extract compositions can also be
prepared by extracting an herbal tea composition detailed herein,
for example, using a suitable solvent (e.g., hot water or alcoholic
water), concentrating the extract, and drying.
[0076] In one embodiment, an herbal extract composition comprising
(including consisting essentially of or consisting of) an extract
of Cyclocarya paliurus leaves, Mori Folium and Green Tea is
prepared using a method comprising the following steps: [0077] i)
providing a mixture of Cyclocarya paliurus leaves, Mori Folium and
Green Tea; [0078] ii) extracting said mixture with water (e.g.,
boiling water) to obtain an aqueous extract; [0079] iii)
concentrating the aqueous extract to obtain a concentrated mixture;
[0080] iv) obtaining a liquid portion of said concentrated mixture;
and [0081] v) drying (e.g., spray-drying) said extract to produce
the herbal extract composition.
[0082] In some embodiments, the method further comprises mixing the
extract with a pharmaceutically acceptable excipient (e.g.,
.beta.-cyclodextrin, maltodextrin, or lactose) before drying.
[0083] The herbal extract compositions used to prepare oral
formulations such as a tablet, a capsule, a granule, a powder, an
effervescent tablet, or an herbal tea formulation.
[0084] Methods for Use
[0085] The herbal tea compositions and the herbal extract
compositions are useful in lowering blood sugar, treating a disease
or condition (e.g., diabetes, hyperglycemia, hypertension or
hyperlipidemia), or providing nutritional supplement, to an
individual in need thereof.
[0086] One aspect of the present invention provides a method of
lowering blood sugar in a subject in need thereof comprising
administering to the subject a therapeutically effective amount of
an herbal tea composition or herbal extract composition detailed
herein. Methods for treating diabetes, hyperglycemia, hypertension
and/or hyperlipidemia are also provided.
[0087] In some embodiments, provided is a method of lowering blood
sugar or treating diabetes, hyperglycemia, hypertension and/or
hyperlipidemia, in a subject in need thereof comprising
administering to the subject a therapeutically effective amount of
an herbal tea composition, an herbal extract composition, a
nutritional composition, or a pharmaceutical composition described
herein, each independently, comprising (including consisting
essentially of or consisting of) an herbal combination detailed
herein, or an extract of the herbal combinations detailed herein,
for example, an herbal combination of Cyclocarya paliurus leaves
and one or more herbs selected from the group consisting of Green
Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and
Polygonati odorati Rhizoma, preferably, an herbal combination of
Cyclocarya paliurus leaves, Green Tea, and Mori Folium. The subject
in need can be a human patient suffering from diabetes, other
metabolic diseases, or other conditions associated with an elevated
blood sugar level. Blood sugar refers to the variety of naturally
occurring carbohydrates, including monosaccharides,
oligosaccharides, and polysaccharides that are normally found in
the blood stream, blood or any serological fraction of the blood,
such as serum. One monosaccharide species, glucose, is the primary
source of energy for cells in all organisms, and therefore, glucose
is one of the most abundant and highly regulated sugars in the
blood. In some but not all embodiments of the present invention,
"lowering blood sugar" specifically refers to lowering blood
glucose. Lowering of blood sugar levels is an effective strategy to
treat and manage human conditions, such as diabetes and other
metabolic conditions that are responsive to reduced blood sugar
level. Therefore, the method described herein can also be applied
to treat any disease or condition responsive to lowering of blood
sugar. In some embodiments, provided is a method for treating
hyperglycemia, hypertension and/or hyperlipidemia in an individual
in need thereof.
[0088] Alternatively, the herbal extract composition, the gel
capsule or the nutritional composition described herein can be used
as a nutritional supplement in a method provided by the present
invention to reduce blood sugar in a subject in need thereof.
"Nutritional supplement" refers to substance that may have
beneficial health effects, but are normally absent or present at
insufficient quantities in a person's diet. As a nutritional
supplement, the herbal extract composition, the gel capsule, or the
nutritional composition should be administered to the subject in
need thereof in conjunction with standard and other therapeutic
means to help the subject manage his or her blood sugar levels.
[0089] "Therapeutically effective amount" or "effective amount" in
the present invention refers to an amount of an herbal tea
composition, an herbal extract composition, a nutritional
composition, or a pharmaceutical composition sufficient to improve
the condition of the subject in need thereof, without causing
serious side-effects. In a preferred embodiment of the present
invention, the herbal tea composition described in Example 1 are
administered orally with a dosage regimen of 2 doses per day and 1
tea bag per dose. The dosage of the herbal tea composition, the
herbal extract composition, the nutritional composition, or the
pharmaceutical composition of the present invention can be adjusted
according to actual situation based on knowledge in the art. The
efficacy of the herbal extract composition, the herbal extract
composition, the nutritional composition, or the pharmaceutical
composition can be measured by methods known in the art for
assessing blood sugar levels in standard animal models (e.g. mice
and rats) or in human subjects, for example, as illustrated in
Example 6.
EXAMPLE
[0090] The following exemplary embodiment further describes the
present invention. Although the description refers to practical
embodiments, it will be clear to one skilled in the art that the
present invention may be practiced with variation of these specific
details. Hence this invention should not be construed as limited to
the embodiments set forth herein.
Example 1 Preparation of an Herbal Tea Bag
[0091] A flow chart illustrating an exemplary method for preparing
an herbal tea bag comprising Cyclocarya paliurus leaves, Mori
Folium and Green Tea is shown in FIG. 2, and described below.
[0092] The herbal tea bag was prepared as follows. Leaves of
Cyclocarya paliurus, Mori Folium and Green Tea according to
production standards of initial ingredients were provided. Each
ingredient was crushed separately, and each crushed leaves were
sieved separately through a 60-mesh to 20-mesh (such as 60-mesh)
sieve to remove fine particles. About 500 grams of crushed leaves
of Cyclocarya paliurus, about 500 grams of crushed Mori Folium, and
about 500 grams of crushed Green Tea were weighed out. The weighed
crushed leaves of Cyclocarya paliurus, Mori Folium and Green Tea
were mixed in a mixer for about 10-30 (such as about 20) minutes to
obtain a uniform mixture. The uniform mixture was divided into
equal portions of about 1-5 g (such as about 1.5 g) each, and each
portion was packaged into a triangular bag made of nylon membrane.
Each bag was placed into individual inner package made of composite
membrane used in food packaging. The quality of the inner-packaged
tea bags was inspected according to company standards. The
inner-packaged tea bags were packaged into outer packages according
to company standards. The quality of the packaging was inspected.
The packaged tea bags that had passed quality inspections were
stored in a dry warehouse at ambient room temperature. Up to 1000
tea bags, 1.5 g per bag could be prepared. The parameters of the
method described herein can be adjusted according to actual
situation.
[0093] The tea bags are administered, for example, to a human at a
dosage of about 2 bags of 1.5 g/bag per day.
Example 2 Preparation of Test Samples and Control Samples
[0094] Sample Formulae:
[0095] Test Sample 1 (S1): Cyclocarya paliurus leaves: 1.0 kg;
Green Tea: 8.0 kg; and Mori Folium: 1.0 kg.
[0096] Test Sample 2 (S2): Cyclocarya paliurus leaves 4.0 kg, Mori
Folium 4.0 kg, and Broadleaf Holly leaves 2.0 kg.
[0097] Test Sample 3 (S3): Cyclocarya paliurus leaves 3.3 kg, Green
Tea 3.3 kg, and Mori Folium 3.3 kg.
[0098] Test Sample 4 (S4): Cyclocarya paliurus leaves 5.0 kg, Green
Tea 1.0 kg, Mori Folium 1.0 kg, Broadleaf Holly leaves 1.0 kg,
Polygonatum odoratum 1.0 kg, and Paeoniae Radix alba 1.0 kg.
[0099] Test Sample 5 (S5): Cyclocarya paliurus leaves 8.0 kg, Green
Tea 0.5 kg, Mori Folium 0.5 kg, Black Tea 0.5 kg, and Puerariae
lobatae Radix 0.5 kg.
[0100] Test Sample 6 (S6): Cyclocarya paliurus leaves 1.0 kg, Green
Tea 1.0 kg, Citri Reticulatae Pericarpium 1.0 kg, Dioscoreae
Rhizoma 1.0 kg, Black Tea 1.0 kg, Scrophulariae Radix 1.0 kg,
Panacis Quinquefolii Radix 1.0 kg, Ginkgo Folium 1.0 kg, Gynostemma
pentaphyllum 1.0 kg, and Corn Stigma 1.0 kg.
[0101] Control Sample 1 (D1): Cyclocarya paliurus leaves: 10
kg.
[0102] Control Sample 2 (D2): Green Tea: 10 kg.
[0103] Control Sample 3 (D3): Mori Folium: 10 kg.
[0104] Control Sample 3 (D4): Cyclocarya paliurus leaves 3.5 kg,
Green Tea 3.5 kg, and Mori Folium 3.0 kg.
[0105] The samples were prepared according to the steps detailed
below, and tested for efficacies in lowering blood sugars, blood
lipids, and blood pressure in animal models.
[0106] Method of Preparation
[0107] Step 1. Each herbal medicine was measured precisely
according to the above composition, broken into pieces separately,
then filtered using 60 mesh to remove fine powders in the raw
ingredient.
[0108] Step 2. Cyclocarya paliurus leaves and other herbal
ingredients were mixed well in a mixer for about 20 mins to obtain
a mixture.
[0109] Step 3. The mixture was aliquoted into triangle-shaped bags,
1.5 g/bag, and the packing material was nylon membrane.
Example 3 Test of Lowering Blood Sugar
[0110] 1. Materials and Methods
[0111] 1) Samples and solution: samples from Test Samples 1-6 and
Control Samples 1-4 were labeled as S1, S2, S3, S4, S5, S6, and D1,
D2, D3, D4, respectively; Streptozotocin (SIGMA), pack size: 1
g/tube, lot#: SLBJ7785V; insulin detection kit, imported and
aliquoted, Nanjing Jiancheng Bioengineering Co., 20141022; 0.9%
NaCl injection (physiological saline), pack size: 250 mL/bottle,
Sichuan Kelun Pharmaceutical Co. Ltd., lot#: C13102005-1; high fat
diet formula (79% basal diet+1% cholesterol+15% fresh yolk+5%
lard), picric acid, etc.
[0112] 2) Instruments: W-80A vortex mixer (Shanghai Medical
Instruments Co. Ltd.); electronic balance, METTLER TOLEDO
(METTLER-TOLEDO group), model: pl303; LDZ5-2 centrifuge (Beijing
Medical Centrifuge Factory); Johnson Stable Blood Glucose Meter
(Johnson & Johnson (China) Medical Device Co. Ltd.); BECKMAN
Synchron CX 5 automatic blood biochemistry analyzer (USA);
microplate reader, Bio-Rad (USA), model: iMark; DCA 2000
glycosylated hemoglobin analyzer (Bayer, Germany); others: platform
scale, and fixed cage, etc.
[0113] 3) Experimental animals: SD rats (SPF level), weight 160-180
g, male, provided by Southern Medical University Laboratory Animal
Center, Certificate#: SCXK (Guangdong)2011-0015. Animals were
raised in SPF level barrier level animal room, animal use license#:
SYXK (Guangdong) 2012-0081.
[0114] 4) Dosage setting: expected dosage for human adults is 3.0
g/60 kgBWday. Dosage used for rats was 10 times that of human. The
dosage was calculated using raw drug amount.
[0115] 5) Statistical analysis: data were processed using SPSS 17.0
statistical tool, parameters were displayed as mean.+-.standard
deviation (x.+-.S), ANOVA test was used for comparison among
groups, p<0.05 was defined as statistically significant.
[0116] 2. Methods and Results
[0117] 2.1 Methods
[0118] 1) Rat diet: Regular diet: cornmeal 80%, flour 15%, soybean
flour 5%; High fat diet: 79% basal diet+1% cholesterol+15% fresh
yolk+5% lard.
[0119] 2) Modeling: 120 SPF level SD rats, male, weight 160-180 g,
were fed for one week adaptively. 10 rats were selected as normal
control group and fed with regular diet, while animals of other
groups were fed with high fat diet for one month, after random
inspection showing an obvious elevation in blood lipid indexes, STZ
was intraperitoneally injected at 35 mg/kg to induce diabetic
models (before injecting, STZ was prepared into 6 mg/mL solution
using 0.1 mmol/L citric acid/sodium citrate buffer (pH=4.5), and
destined to be finished within 60 mins). Fasting venous blood was
collected from tails on the 7.sup.th day after STZ injection. Blood
sugar was measured using blood sugar meter, and successful models
were regarded as with blood sugar .gtoreq.16.7 mmol/L. After the
models were stable, animals were grouped based on blood lipids and
blood sugar, orally administered test drugs and control drugs, and
all indexes were monitored.
[0120] 3) Grouping and drug administration: 110 successfully
modeled animals in relatively good conditions were evenly separated
into 11 groups based on blood sugar levels and weights: 10 rats per
group, named as type II diabetes model control group (administered
with distilled water), S1 group, S2 group, S3 group, S4 group, S5
group, S6 group, D1 group, D2 group, D3 group, and D4 group. Normal
un-modeled SD rats were set as normal control (administered with
distilled water). Each group was orally administered with drug
according to corresponding dosage, once per day, for a period of 4
weeks (4 W).
[0121] 2.2 Measurements
[0122] 1) Regular observation was performed, and weights were
recorded every 2 weeks.
[0123] 2) Blood sugar was measured before, after 2 weeks and after
4 weeks of drug administration, using blood sugar meter.
[0124] 3) Serum insulin and glycosylated hemoglobin levels were
measured.
[0125] 4) Sugar tolerance test: the test was carried out 2 days
before the whole experiment ended. Sugar tolerance test was carried
out as following: animals were kept under fasting for about 6
hours, different concentrations of test samples were given to each
group, glucose was orally administered at 2.0 g/kg after 15-20
mins, blood sugar levels were measured at 0, 0.5, and 2 hours after
administering glucose, and the changes of areas under the blood
sugar curve of each time point after administering glucose were
studied for both model control group and experimental groups. The
area under the blood sugar curve=1/2.times.(blood sugar level at 0
h+blood sugar level at 0.5 h).times.0.5+1/2.times.(blood sugar
level at 2 h+blood sugar level at 0.5
h).times.1.5=0.25.times.(blood sugar level at 0 h+4.times. blood
sugar level at 0.5 h+3.times. blood sugar level at 2 h).
[0126] 2.3 Results
[0127] 1) The effect on blood sugar of type II diabetes rat: As
shown in Table 2, the rat blood sugar level of each diabetes model
group significantly elevated before giving drugs, compared to that
of the normal control group, indicating successful modeling. After
2 W of treatment, the blood sugar levels of S1-S6 groups, D1 group
and D4 group all decreased, compared to that of model control
group. After 4 W of treatment, the blood sugar levels of S1-S6
groups, D1 group and D4 group all decreased.
TABLE-US-00002 TABLE 2 The effect of samples on blood sugar level
of type II diabetes rats (x .+-. S) Blood sugar Blood sugar Blood
sugar level before level after level after treatment 2 W treatment
4 W treatment Group n (mmol/L) (mmol/L) (mmol/L) Normal 10 5.08
.+-. 0.85 5.46 .+-. 0.92 5.63 .+-. 0.82 control group Model 10
.sup. 21.82 .+-. 3.25.sup.## 21.26 .+-. 3.10.sup.## 20.58 .+-.
2.67.sup.## control group S1 group 10 21.59 .+-. 2.81 18.72 .+-.
2.68* 17.09 .+-. 2.43* S2 group 10 21.73 .+-. 2.73 18.70 .+-. 2.33*
17.34 .+-. 2.28* S3 group 10 21.71 .+-. 2.32 17.69 .+-. 2.81* 17.17
.+-. 2.37* S4 group 10 21.63 .+-. 2.31 18.76 .+-. 2.52* 17.49 .+-.
3.06* S5 group 10 22.15 .+-. 2.61 18.71 .+-. 3.08* 17.34 .+-. 2.65*
S6 group 10 21.78 .+-. 2.35 18.62 .+-. 2.94* 17.36 .+-. 3.02* D1
group 10 22.44 .+-. 2.47 18.71 .+-. 2.46* 17.58 .+-. 2.84* D2 group
10 21.78 .+-. 2.50 19.70 .+-. 3.28 19.53 .+-. 3.11 D3 group 10
22.06 .+-. 2.42 19.48 .+-. 2.86 19.79 .+-. 2.98 D4 group 10 21.95
.+-. 2.39 18.75 .+-. 2.90 17.79 .+-. 2.62 Note: compared to normal
control group: .sup.#p < 0.05, .sup.##p < 0.01; compared to
model control group: *p < 0.05, **p < 0.01.
[0128] 2) The effects on serum insulin level and glycosylated
hemoglobin level of type II diabetes rats: As shown in Table 3,
compared to those of the normal control group, rats in model
control group showed significantly decreased serum insulin level
(p<0.01) and significantly elevated glycosylated hemoglobin
level (p<0.01) after fed with high fat diet and modeled for
diabetes, indicating hyperlipidemia rat models were successful.
Compared to the model control group, rat serum insulin levels of
S1-S6 groups, D1 group and D4 group all increased. Compared to the
model control group, rat glycosylated hemoglobin levels of S1-S6
groups, D1 group and D4 group all decreased (p<0.05).
TABLE-US-00003 TABLE 3 The effect of samples on serum insulin level
and glycosylated hemoglobin level of type II diabetes rats (x .+-.
S) Glycosylated Insulin hemoglobin Group n (mmol/L) (mmol/L) Normal
10 19.85 .+-. 2.78 3.96 .+-. 0.59 control group Model 10 .sup. 9.42
.+-. 2.16.sup.## 9.37 .+-. 1.29.sup.## control group S1 group 10
13.87 .+-. 2.74* 7.40 .+-. 1.23* S2 group 10 13.81 .+-. 2.62* 7.34
.+-. 1.44* S3 group 10 13.50 .+-. 3.26* 7.40 .+-. 1.87* S4 group 10
13.55 .+-. 2.66* 7.38 .+-. 1.42* S5 group 10 13.49 .+-. 2.70* 7.42
.+-. 1.59* S6 group 10 13.54 .+-. 2.21* 7.23 .+-. 1.28* D1 group 10
13.16 .+-. 2.52* 7.20 .+-. 1.70* D2 group 10 10.75 .+-. 2.89 8.64
.+-. 2.33 D3 group 10 10.88 .+-. 2.64 8.45 .+-. 1.86 D4 group 10
13.02 .+-. 2.02 7.62 .+-. 1.16* Note: compared to normal control
group: .sup.#p < 0.05, .sup.##p < 0.01; compared to model
control group: *p < 0.05, **p < 0.01.
[0129] 3) The sugar tolerance test results of type II diabetes
rats: As shown in Table 4, the areas under the blood sugar curves
of S1-S6 groups, D1 group and D4 group all decreased, compared to
that of model control group.
TABLE-US-00004 TABLE 4 The effect of samples on sugar tolerance of
type II diabetes rats (x .+-. S) Area under blood Group n sugar
curve Normal 10 11.23 .+-. 0.89 control group Model 10 40.75 .+-.
6.18.sup.## control group S1 group 10 32.56 .+-. 5.95* S2 group 10
31.74 .+-. 5.93* S3 group 10 26.01 .+-. 5.47** S4 group 10 32.12
.+-. 6.72* S5 group 10 31.89 .+-. 5.97* S6 group 10 31.90 .+-.
6.31* D1 group 10 32.03 .+-. 5.72* D2 group 10 36.74 .+-. 7.01 D3
group 10 35.92 .+-. 6.45 D4 group 10 33.17 .+-. 6.20* Note:
compared to normal control group: .sup.#p < 0.05, .sup.##p <
0.01; compared to model control group: p > 0.05 for all.
[0130] 3. Conclusion
[0131] S1-S6, D1 and D4 showed clear effects on lowering blood
sugar for diabetes rat models, and the compositions of S1-S6
exhibited synergistic or enhanced effects in lowering blood
sugar.
Example 4 Test of Lowering Blood Lipids
[0132] 1. Materials and Methods
[0133] 1) Samples and solution: samples from Test Samples 1-6 and
Control Samples 1-4 were labeled as S1, S2, S3, S4, S5, S6, and D1,
D2, D3, D4, respectively; 0.9% NaCl injection (physiological
saline), pack size: 250 mL/bottle, Sichuan Kelun Pharmaceutical Co.
Ltd., lot#: C13102005-1; high fat diet formula (79% basal diet+1%
cholesterol+15% fresh yolk+5% lard), distilled water, and picric
acid, etc.
[0134] 2) Instruments: W-80A vortex mixer (Shanghai Medical
Instruments Co. Ltd.); electronic balance, METTLER TOLEDO
(METTLER-TOLEDO group), model: pl303; LDZ5-2 centrifuge (Beijing
Medical Centrifuge Factory); BECKMAN Synchron CX 5 automatic blood
biochemistry analyzer (USA); others: platform scale, and fixed
cage, etc.
[0135] 3) Experimental animals: SD rats (SPF level), weight 160-180
g, male, provided by Southern Medical University Laboratory Animal
Center, Certificate#: SCXK (Guangdong)2011-0015. Animals were
raised in SPF level barrier level animal room, animal use license#:
SYXK (Guangdong) 2012-0081.
[0136] 4) Dosage setting: expected dosage for human adults is 3.0
g/60 kgBWday. Dosage used for rats was 10 times that of human. The
dosage was calculated using raw drug amount.
[0137] 5) Statistical analysis: data were processed using SPSS 17.0
statistical tool, parameters were displayed as mean.+-.standard
deviation (x.+-.S), ANOVA test was used for comparison among
groups, p<0.05 was defined as statistically significant.
[0138] 2. Methods and Results
[0139] 2.1 Grouping and Methods
[0140] 120 SPF level SD rats, male, weight 160-180 g, were fed for
one week adaptively. 10 rats were selected as normal control group
and fed with regular diet; the rest animals were fed with high fat
diet. After feeding continuously for 4 weeks (blood was drawn at
regular intervals to test for the four indexes of blood lipids, in
order to determine whether models were successful), 110
successfully modeled animals in relatively good conditions were
chosen and evenly separated into 11 groups based on blood lipid
levels and weights: 10 rats per group, named as hyperlipidemia
model control group (administered with distilled water), S1 group,
S2 group, S3 group, S4 group, S5 group, S6 group, D1 group, D2
group, D3 group and D4 group.
[0141] After feeding high fat diet for 4 weeks, drugs were
administered according to the above grouping with high fat diet
continuously provided (the normal control group was fed with normal
diet), drugs were administered once per day, for a period of 4 W.
After the last drug administration, animals were kept overnight
fasting, weighed the next day, then anaesthetized using chloral
hydrate, after drawing blood through inferior vena cava, animals
were executed. Supernatant was obtained by centrifuging the blood
samples, then serum biochemical indexes were measured.
[0142] 2.2 Measurements
[0143] 1) Regular observation was performed, and weights were
recorded every week.
[0144] 2) Rat serum lipid indexes of each group: blood was drawn
from orbital venous plexus every 2 weeks, serum was separated for
the detection of: total cholesterol (TC), triglyceride (TG),
high-density lipoprotein cholesterol (HDL-C), and low-density
lipoprotein cholesterol (LDL-C).
[0145] 2.3 Results
[0146] The effects on serum TC, TG, HDL-C, LDL-C, and TC/HDL-C are
shown in Tables 5-7. As shown in Table 5, after fed with high fat
diet for 4 W, the model control group rats showed significantly
elevated levels of TC and LDL-C (p<0.01), and significant
elevation of TG (p<0.05), compared to those of normal control
group, indicating successful modeling of hyperlipidemia rats. Rats
were evenly separated into 4 groups according to blood lipid level.
As shown in Table 6, after 2 W treatment, drug samples of S1-S6
groups, D1 group and D4 group all functioned to lower TC, TG and
LDL-C levels in serum, compared to the model control group. As
shown in Table 7, after 4 W treatment, drug samples of S1-S6
groups, D1 group and D4 group could lower TC, TG and LDL-C levels
in serum (p<0.05 or p<0.01), compared to the model control
group.
TABLE-US-00005 TABLE 5 Serum lipid data of successfully modeled
evenly grouped rats (x .+-. S) TC TG HDL-C LDL-C Group n (mmol/L)
(mmol/L) (mmol/L) (mmol/L) Normal 10 1.34 .+-. 0.10 1.72 .+-. 0.54
0.60 .+-. 0.07 0.31 .+-. 0.06 control group Model 10 .sup. 1.95
.+-. 0.31.sup.## .sup. 2.37 .+-. 0.34.sup.## 0.63 .+-. 0.08 .sup.
0.45 .+-. 0.08.sup.## control group S1 group 10 1.94 .+-. 0.33 2.34
.+-. 0.41 0.59 .+-. 0.09 0.46 .+-. 0.09 S2 group 10 1.96 .+-. 0.35
2.37 .+-. 0.52 0.64 .+-. 0.10 0.44 .+-. 0.08 S3 group 10 1.94 .+-.
0.30 2.38 .+-. 0.46 0.59 .+-. 0.08 0.44 .+-. 0.09 S4 group 10 1.95
.+-. 0.31 2.32 .+-. 0.56 0.60 .+-. 0.11 0.45 .+-. 0.10 S5 group 10
1.92 .+-. 0.30 2.33 .+-. 0.50 0.59 .+-. 0.09 0.44 .+-. 0.08 S6
group 10 1.93 .+-. 0.34 2.38 .+-. 0.49 0.62 .+-. 0.09 0.45 .+-.
0.09 D1 group 10 1.93 .+-. 0.38 2.34 .+-. 0.58 0.62 .+-. 0.11 0.46
.+-. 0.10 D2 group 10 1.94 .+-. 0.36 2.38 .+-. 0.45 0.63 .+-. 0.09
0.45 .+-. 0.07 D3 group 10 1.93 .+-. 0.30 2.35 .+-. 0.52 0.58 .+-.
0.10 0.44 .+-. 0.08 D4 group 10 1.95 .+-. 0.29 2.37 .+-. 0.61 0.59
.+-. 0.08 0.44 .+-. 0.09 Note: compared to normal control group:
.sup.#p < 0.05, .sup.##p < 0.01; compared to model control
group: p > 0.05 for all.
TABLE-US-00006 TABLE 6 Rat serum lipid data of each group after 2 W
of drug administration (x .+-. S) TC TG HDL-C LDL-C Group n
(mmol/L) (mmol/L) (mmol/L) (mmol/L) Normal 10 1.23 .+-. 0.28 1.70
.+-. 0.38 0.50 .+-. 0.09 0.30 .+-. 0.09 control group Model 10 2.34
.+-. 0.36.sup.## 2.90 .+-. 0.31.sup.## 0.58 .+-. 0.07 0.58 .+-.
0.10.sup.## control group S1 group 10 1.89 .+-. 0.38* 2.26 .+-.
0.53* 0.59 .+-. 0.09 0.44 .+-. 0.06* S2 group 10 1.88 .+-. 0.40*
2.24 .+-. 0.50* 0.57 .+-. 0.06 0.43 .+-. 0.07* S3 group 10 1.84
.+-. 0.28* 2.14 .+-. 0.45* 0.56 .+-. 0.07 0.40 .+-. 0.06* S4 group
10 1.85 .+-. 0.34* 2.26 .+-. 0.49* 0.60 .+-. 0.10 0.42 .+-. 0.08*
S5 group 10 1.87 .+-. 0.31* 2.22 .+-. 0.56* 0.59 .+-. 0.09 0.43
.+-. 0.06* S6 group 10 1.83 .+-. 0.42* 2.21 .+-. 0.40* 0.60 .+-.
0.08 0.43 .+-. 0.09* D1 group 10 1.88 .+-. 0.31* 2.31 .+-. 0.58*
0.59 .+-. 0.11 0.45 .+-. 0.07* D2 group 10 2.18 .+-. 0.40 2.70 .+-.
0.72 0.60 .+-. 0.10 0.54 .+-. 0.09 D3 group 10 2.14 .+-. 0.36 2.68
.+-. 0.59 0.58 .+-. 0.08 0.55 .+-. 0.07 D4 group 10 1.94 .+-. 0.28*
2.45 .+-. 0.35* 0.59 .+-. 0.09 0.51 .+-. 0.05* Note: compared to
normal control group: .sup.#p < 0.05, .sup.##p < 0.01;
compared to model control group: *p < 0.05, **p < 0.01.
TABLE-US-00007 TABLE 7 Rat serum lipid data of each group after 4 W
of drug administration (x .+-. S) TC TG HDL-C LDL-C Group n
(mmol/L) (mmol/L) (mmol/L) (mmol/L) Normal 10 1.20 .+-. 0.29 1.74
.+-. 0.39 0.59 .+-. 0.08 0.34 .+-. 0.06 control group Model 10 2.61
.+-. 0.43.sup.## 2.99 .+-. 0.34.sup.## 0.58 .+-. 0.06 0.66 .+-.
0.08.sup.## control group S1 group 10 2.08 .+-. 0.40* 2.47 .+-.
0.40* 0.59 .+-. 0.08 0.54 .+-. 0.06* S2 group 10 2.14 .+-. 0.38*
2.44 .+-. 0.39* 0.58 .+-. 0.07 0.51 .+-. 0.07* S3 group 10 1.98
.+-. 0.37* 2.28 .+-. 0.37** 0.56 .+-. 0.06 0.45 .+-. 0.06** S4
group 10 2.12 .+-. 0.34* 2.46 .+-. 0.36* 0.57 .+-. 0.09 0.52 .+-.
0.09* S5 group 10 2.05 .+-. 0.40* 2.38 .+-. 0.42* 0.60 .+-. 0.06
0.54 .+-. 0.07* S6 group 10 2.07 .+-. 0.38* 2.41 .+-. 0.35* 0.59
.+-. 0.07 0.53 .+-. 0.08* D1 group 10 2.14 .+-. 0.29* 2.39 .+-.
0.41* 0.60 .+-. 0.09 0.54 .+-. 0.08* D2 group 10 2.45 .+-. 0.43
2.78 .+-. 0.50 0.57 .+-. 0.07 0.62 .+-. 0.09 D3 group 10 2.56 .+-.
0.42 2.69 .+-. 0.45 0.58 .+-. 0.06 0.63 .+-. 0.08 D4 group 10 2.06
.+-. 0.30 2.52 .+-. 0.39* 0.59 .+-. 0.08 0.55 .+-. 0.05* Note:
compared to normal control group: .sup.#p < 0.05, .sup.##p <
0.01; compared to model control group: *p < 0.05, **p <
0.01.
[0147] 3. Conclusion
[0148] S1-S6, D1 and D4 showed clear effects in lowering blood
lipid levels in hyperlipidemia rat models, and the compositions of
S1-S6 exhibited synergistic or enhanced effects in lowering blood
lipids.
Example 5 Test of Lowering Blood Pressure
[0149] 1. Materials and Methods
[0150] 1) Samples and solution: samples from Test Samples 1-6 and
Control Samples 1-4 were labeled as S1, S2, S3, S4, S5, S6, and D1,
D2, D3, D4, respectively; 0.9% NaCl injection (physiological
saline), pack size: 250 mL/bottle, Sichuan Kelun Pharmaceutical Co.
Ltd., lot#: C13102005-1; distilled water, and picric acid, etc.
[0151] 2) Instruments: DKB-501A High Precision Water Bath (Shanghai
Senxin Laboratory Apparatus Ltd.); electronic constant temperature
drying cabinet (Changsha Medical Devices Ltd.); PowerLab/4SP ML125
non-invasive blood pressure measurement system (ML125/R NIBP,
MLT1199 Disposable BP Transducer/Cable Kit; ADInstruments Ltd.,
Australia); MP120-1 electronic balance (Shanghai Number Two Balance
Instrument Factory).
[0152] 3) Experimental animals: SHR rats (SPF level), weight
190-230 g, male, provided by Beijing Vital River Laboratory Animal
Technology Co. Ltd., Certificate#: SCXK (Beijing) 2012-0001.
Animals were raised in SPF level barrier level animal room, animal
use license#: SYXK (Guangdong) 2012-0081. WISTAR male rats (SPF
level) were provided by Beijing Vital River Laboratory Animal
Technology Co. Ltd., Certificate#: SCXK (Beijing) 2012-0001.
[0153] 4) Dosage setting: expected dosage for human adults is 3.0
g/60 kgBWday. Dosage used for rats was 10 times that of human. The
dosage was calculated using raw drug amount.
[0154] 5) Statistic analysis: data were processed using SPSS 17.0
statistical tool, parameters were displayed as mean.+-.standard
deviation (xe.+-.S), ANOVA test was used for comparison among
groups, p<0.05 was defined as statistically significant.
[0155] 2. Methods and Results
[0156] 9-10 week old male spontaneously hypertensive rats (SHR)
were randomly separated into 11 groups, 10 rats per group, named as
hypertension model control group (administered with distilled
water), S1 group, S2 group, S3 group, S4 group, S5 group, S6 group,
D1 group, D2 group, D3 group and D4 group. 10 normal WISTAR rats
were selected as normal control group (administered with distilled
water). Animals in each group were intragastrically administered
with different dosages of drugs, once per day, for a period of 4 W.
Rat caudal artery blood pressure (systolic arterial pressure, SAP,
mmHg) was measured using non-invasive caudal artery blood pressure
measurement system, before, after 2 W, and after 4 W treatment.
[0157] Non-invasive tail cuff method (NIBP): a rat was placed into
the rat fixer, allowing its tail exposed. Infrared heater was set
to be 38.degree. C. Rat tail was heated under radiation for about
10 mins until the tail becoming soft and caudal artery expanding
sufficiently. Pressured tail cuff was passed through the rat tail
and fixed at the tail root, so that rat caudal artery was in tight
contact with the pulse sensor of the PowerLab ML125/R non-invasive
caudal artery blood pressure measurement system. The pulse waveform
was monitored, and blood pressure could be measured when stable
pulse wave appeared. When the animal calmed down, pressure was
increased in the tail cuff at 90-420BPM (rat pressure increasing
level), pulse wave could be seen to gradually diminish until
disappear, then gas was gradually released in the tail cuff,
pressure gradually decreased in the tail cuff, and pulse wave
reappeared when the pressure reached SAP, the blood pressure of
which was defined as the rat tail SAP. The measurement was repeated
for 3 times, and average value was obtained. The pressure drop
value (blood pressure drop value) was calculated as SAP after
treatment minus SAP before treatment. The result is shown in Table
8.
TABLE-US-00008 TABLE 8 The effect of samples on blood pressure
(SAP, mmHg) of SHR rats (x .+-. S) Blood pres- Blood pres- Blood
pres- sure before sure after sure after treatment 2 W treatment 4 W
treatment Group n (SAP, mmHg) (SAP, mmHg) (SAP, mmHg) Normal 10
108.42 .+-. 14.65 110.52 .+-. 15.68 115.83 .+-. 17.58 control group
Model 10 .sup. 176.27 .+-. 14.28.sup.# .sup. 182.24 .+-.
17.10.sup.# 189.17 .+-. 13.76.sup.# control group S1 group 10
176.30 .+-. 15.42 173.54 .+-. 16.22 173.70 .+-. 15.83* S2 group 10
175.94 .+-. 13.24 173.25 .+-. 13.50 172.14 .+-. 13.68* S3 group 10
177.20 .+-. 13.22 169.50 .+-. 15.61* 167.81 .+-. 15.64* S4 group 10
178.44 .+-. 15.10 172.31 .+-. 16.35 172.80 .+-. 14.47* S5 group 10
175.64 .+-. 14.75 175.24 .+-. 13.57 171.45 .+-. 13.92* S6 group 10
176.84 .+-. 14.56 172.25 .+-. 15.53 172.05 .+-. 13.65* D1 group 10
177.16 .+-. 13.67 174.60 .+-. 16.22 174.12 .+-. 14.60* D2 group 10
177.48 .+-. 16.13 178.83 .+-. 18.31 180.07 .+-. 14.81 D3 group 10
176.68 .+-. 15.60 177.98 .+-. 16.83 181.12 .+-. 15.10 D4 group 10
177.47 .+-. 14.31 174.86 .+-. 13.16 176.18 .+-. 12.35 Note:
compared to normal control group: .sup.#p < 0.01; compared to
model control group: *p < 0.05.
[0158] The result showed that, rats in the model control group had
significantly elevated blood pressure compared to that of rats in
the normal control group, indicating spontaneously hypertensive
rats as successful models. Drugs of S1-S6 groups, D1 group and D4
group significantly lowered the blood pressure of SHR rats after 4
W treatment (p<0.05), compared to model control group.
[0159] 3. Conclusion
[0160] S1-S6, D1 and D4 samples showed significant effects in
lowering blood pressure, and the compositions of S1-S6 exhibited
synergistic or enhanced effects in lowering blood pressure.
Example 6 In Vivo Efficacy Determination
[0161] Animal subjects or human subjects are assigned randomly into
a control group and a treatment group. The treatment group is
provided a therapeutically effective amount of the herbal tea
composition, the herbal extract composition, the nutritional
composition, or the pharmaceutical composition comprising
(including consisting essentially of or consisting of) a tea bag or
an extract of the herb combinations (e.g., Cyclocarya paliurus
leaves, Green Tea, and Mori Folium), with a predetermined dosage
regimen over a predetermined period of time. The control group is
provided with a placebo with the same dosage regimen and treatment
duration. Blood glucose levels in all subjects of both experimental
groups are monitored prior to the experiment, during the course of
the experiment, and at the end of the experiment. Standard blood
glucose kits, such as those relying on the nonspecific reducing
property of glucose, and those using glucose specific enzymes, are
used to monitor the blood glucose levels of the subjects.
Statistical analysis is performed to compare the blood glucose
levels at various time points in the course of the experiment
between the control group and the treatment group, which is used
along with other relevant data to determine the efficacy of the
methods of treatment disclosed in the present invention.
[0162] The present invention only listed some specific examples.
However, the characteristics of one or more of the practical
embodiments can be combined with those from one or more of other
practical embodiments to obtain combined exemplary embodiments,
which are also under the protection scope of the present invention,
and should be treated as having been disclosed in the present
invention.
* * * * *