U.S. patent application number 14/632653 was filed with the patent office on 2016-09-01 for herbal composition for diabetic retinopathy.
The applicant listed for this patent is HAN SHENG PHARMTECH, INC.. Invention is credited to Kun-Yi Hong, Shorong-Shii Liou, I-Min Liu.
Application Number | 20160250271 14/632653 |
Document ID | / |
Family ID | 56798088 |
Filed Date | 2016-09-01 |
United States Patent
Application |
20160250271 |
Kind Code |
A1 |
Liou; Shorong-Shii ; et
al. |
September 1, 2016 |
HERBAL COMPOSITION FOR DIABETIC RETINOPATHY
Abstract
A herbal composition for diabetic retinopathy includes 40 wt %
of an ethanol extract of Astragalus membranaceus, 8 wt % of an
ethanol extract of Angelica sinensis and 52 wt % of a water extract
of Dendrobium officinale. The present invention further relates to
a method for diabetic retinopathy by administrating the herbal
composition to a subject in need.
Inventors: |
Liou; Shorong-Shii;
(Pingtung City, TW) ; Liu; I-Min; (Pingtung City,
TW) ; Hong; Kun-Yi; (Pingtung City, TW) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HAN SHENG PHARMTECH, INC. |
Pingtung County |
|
TW |
|
|
Family ID: |
56798088 |
Appl. No.: |
14/632653 |
Filed: |
February 26, 2015 |
Current U.S.
Class: |
424/725 |
Current CPC
Class: |
A61K 2236/33 20130101;
A61K 36/232 20130101; A61K 2236/333 20130101; A61K 36/232 20130101;
A61K 36/8984 20130101; A61K 2236/331 20130101; A61K 36/481
20130101; A61K 36/481 20130101; A61K 36/8984 20130101; A61K 2300/00
20130101; A61K 2300/00 20130101; A61K 2300/00 20130101 |
International
Class: |
A61K 36/481 20060101
A61K036/481; A61K 36/8984 20060101 A61K036/8984 |
Claims
1. A herbal composition for diabetic retinopathy, comprising 40 wt
% of an ethanol extract of Astragalus membranaceus, 8 wt % of an
ethanol extract of Angelica sinensis and 52 wt % of a water extract
of Dendrobium officinale.
2. The herbal composition for diabetic retinopathy as claimed in
claim 1, wherein the ethanol of Astragalus membranaceus is
manufactured by extracting a root sample of Astragalus membranaceus
with 95% ethanol.
3. The herbal composition for diabetic retinopathy as claimed in
claim 1, wherein the ethanol extract of Angelica sinensis is
manufactured by extracting a root sample of Angelica sinesis with
95% ethanol.
4. The herbal composition for diabetic retinopathy as claimed in
claim 1, wherein the water extract of Dendrobium officinale is
manufactured by extracting a stem sample of Dendrobium officinale
with water.
5. The herbal composition for diabetic retinopathy as claimed in
claim 4, wherein the water extract of Dendrobium officinale is
manufactured by extracting the stem sample of Dendrobium officinale
with water at 50-80.degree. C., followed by partitioning with 95%
ethanol at 50-80.degree. C. to obtain a precipitate as the water
extract of Dendrobium officinale.
6. A method for diabetic retinopathy, by administering the herbal
composition as claimed in claim 1 to a subject in need thereof to
relieve symptoms of diabetic retinopathy.
7. The method for diabetic retinopathy as claimed in claim 6,
wherein the herbal composition is administered to the subject in
need thereof in a dosage of 100 mg/per kilogram of body weight per
day for 15-60 days.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a herbal composition and,
more particularly, to a herbal composition for diabetic
retinopathy. The present invention further relates to a method for
diabetic retinopathy by administrating the herbal composition to a
subject in need.
[0003] 2. Description of the Related Art
[0004] Diabetic retinopathy is a complication of diabetes, which is
caused by hyperglycemia-induced incompetence of the vascular walls,
resulting in microvascular retinal changes, such as dysfunction of
blood-retinal barrier and hyperpermeability of capillary
circulation. Moreover, diabetic retinopathy is the leading cause of
blindness in patients with diabetes.
[0005] Conventional methods for diabetic retinopathy include laser
surgery, vitrectomy and intraocular injection of corticosteroids.
However, all of the conventional methods belong to invasive
treatments but cannot completely cure diabetic retinopathy.
Therefore, patients with diabetic retinopathy have to monitor blood
glucose level to adapt to maintain normal blood glucose level
(euglycemia) all the time. Furthermore, intraocular injection of
corticosteroids can also lead to side effects such as
steroid-induced disorders. In light of this, it is necessary to
improve the conventional method for diabetic retinopathy.
[0006] Dendrobium officinale not only can be used to lower the
blood glucose level, improving diabetes-related disorders, but also
can be used as the active ingredient for retinal disorders.
However, Dendrobium officinale cannot be used for diabetic
retinopathy effectively.
SUMMARY OF THE INVENTION
[0007] It is therefore the objective of this invention to provide a
herbal composition used as an active ingredient for diabetic
retinopathy.
[0008] It is another objective of this invention to provide a
method for diabetic retinopathy without side effects lead by the
conventional methods.
[0009] A herbal composition for diabetic retinopathy includes 40 wt
% of an ethanol extract of Astragalus membranaceus, 8 wt % of an
ethanol extract of Angelica sinensis and 52 wt % of a water extract
of Dendrobium officinale.
[0010] In a preferred form shown, the ethanol of Astragalus
membranaceus is manufactured by extracting a root sample of
Astragalus membranaceus with 95% ethanol.
[0011] In a preferred form shown, the ethanol extract of Angelica
sinensis is manufactured by extracting a root sample of Angelica
sinensis with 95% ethanol.
[0012] In a preferred form shown, the water extract of Dendrobium
officinale is manufactured by extracting a stem sample of
Dendrobium officinale with water.
[0013] In a preferred form shown, the water extract of Dendrobium
officinale is manufactured by extracting the stem sample of
Dendrobium officinale with water at 50-80.degree. C., followed by
partitioning with 95% ethanol at 50-80.degree. C. to obtain a
precipitate as the water extract of Dendrobium officinale.
[0014] A method for diabetic retinopathy includes administering the
herbal composition to a subject in need thereof to relieve symptoms
of diabetic retinopathy.
[0015] In a preferred form shown, the herbal composition is
administered to the subject in need thereof in a dosage of 100
mg/per kilogram of body weight per day for 15-60 days.
[0016] Further scope of the applicability of the present invention
will become apparent from the detailed description given
hereinafter. However, it should be understood that the detailed
description and specific examples, while indicating preferable
embodiments of the invention, are given by way of illustration
only, since various others will become apparent from this detailed
description to those skilled in the art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The patent or application file contains at least one drawing
executed in color. Copies of this patent or patent application
publication with color drawing(s) will be provided by the Office
upon request and payment of the necessary fee.
[0018] The present invention will become more fully understood from
the detailed description given hereinafter and the accompanying
drawings which are given by way of illustration only, and thus are
not limitative of the present invention, and wherein:
[0019] FIG. 1 depicts a line graph illustrating intraocular
pressure of rats (groups C0-C4) on day 1, day 15, day 30, day 45
and day 60.
[0020] FIG. 2a depicts a fundus photograph of rat (group C0) on day
1.
[0021] FIG. 2b depicts a fundus photograph of rat (group C0) on day
15.
[0022] FIG. 2c depicts a fundus photograph of rat (group C0) on day
30.
[0023] FIG. 2d depicts a fundus photograph of rat (group C0) on day
45.
[0024] FIG. 2e depicts a fundus photograph of rat (group C0) on day
60.
[0025] FIG. 3a depicts a fundus photograph of rat (group C1) on day
1.
[0026] FIG. 3b depicts a fundus photograph of rat (group C0) on day
15.
[0027] FIG. 3c depicts a fundus photograph of rat (group C1) on day
30.
[0028] FIG. 3d depicts a fundus photograph of rat (group C1) on day
45.
[0029] FIG. 3e depicts a fundus photograph of rat (group C1) on day
60.
[0030] FIG. 4a depicts a fundus photograph of rat (group C2) on day
1.
[0031] FIG. 4b depicts a fundus photograph of rat (group C2) on day
15.
[0032] FIG. 4c depicts a fundus photograph of rat (group C2) on day
30.
[0033] FIG. 4d depicts a fundus photograph of rat (group C2) on day
45.
[0034] FIG. 4e depicts a fundus photograph of rat (group C2) on day
60.
[0035] FIG. 5a depicts a fundus photograph of rat (group C3) on day
1.
[0036] FIG. 5b depicts a fundus photograph of rat (group C3) on day
15.
[0037] FIG. 5c depicts a fundus photograph of rat (group C3) on day
30.
[0038] FIG. 5d depicts a fundus photograph of rat (group C3) on day
45.
[0039] FIG. 5e depicts a fundus photograph of rat (group C3) on day
60.
[0040] FIG. 6a depicts a fundus photograph of rat (group C4) on day
1.
[0041] FIG. 6b depicts a fundus photograph of rat (group C4) on day
15.
[0042] FIG. 6c depicts a fundus photograph of rat (group C4) on day
30.
[0043] FIG. 6d depicts a fundus photograph of rat (group C4) on day
45.
[0044] FIG. 6e depicts a fundus photograph of rat (group C4) on day
60.
[0045] In the various figures of the drawings, the same numerals
designate the same or similar parts. Furthermore, when the term
"first", "second", "third", "fourth", "inner", "outer" "top",
"bottom" and similar terms are used hereinafter, it should be
understood that these terms refer only to the structure shown in
the drawings as it would appear to a person viewing the drawings,
and are utilized only to facilitate describing the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0046] An embodiment of a herbal composition for diabetic
retinopathy according to preferred teachings of the present
invention includes 40 wt % of an ethanol extract of Astragalus
membranaceus, 8 wt % of an ethanol extract of Angelica sinensis and
52 wt % of a water extract of Dendrobium officinale. With such
performance, the herbal composition rich in indicator ingredients
such as ferulic acid and polysaccharides can effectively relieve
symptoms of diabetic retinopathy.
[0047] The method to manufacture the ethanol extract of Astragalus
membranaceus, the ethanol extract of Angelica sinensis and the
water extract of Dendrobium officinale are the prior art well-known
in the field, and therefore are not limited to the following
statement.
[0048] As an example, the ethanol extract of Astragalus
membranaceus is manufactured by extracting a root sample of
Astragalus membranaceus with 95% ethanol, while the ethanol extract
of Angelica sinensis is manufactured by extracting a root sample of
Angelica sinensis with 95% ethanol. In this embodiment, the root
sample of Astragalus membranaceus (1 kg) is mixed with the root
sample of Angelica sinensis (200 g), followed by extracting with
95% ethanol (4 L.)
[0049] Moreover, the water extract of Dendrobium officinale is
manufactured by extracting a stem sample of Dendrobium officinale
with water. For example, the stem sample of Dendrobium officinale
can be extracted with water at 50-80.degree. C., followed by
partitioning with 95% ethanol at 50-80.degree. C. to obtain a
precipitate as the water extract of Dendrobium officinale. In this
embodiment, the stem sample of Dendrobium officinale (1 kg) is
mixed and extracted with heated water (4 L) for 2 hours. The
obtained solution is vacuum-concentrated (final volume to 1 L),
followed by partitioning with pre-cooled 95% ethanol (3 L,
4.degree. C.) overnight. The water extract of Dendrobium officinale
is obtained as a precipitate after centrifugation at 12,000 rpm for
20 minutes, followed by removing the supernatant.
[0050] The herbal composition according to the present invention
can effectively recover the hyperglycemia-induced damages and
relieve symptoms of diabetic retinopathy, thereby being potential
to be applied to pharmaceutical industry, being an active
ingredient of medication or health products for diabetic
retinopathy. In the present invention, the herbal composition can
be given to any subject in need individually or combined with any
acceptable excipients, for example carriers or other ingredients,
and is capable of being further manufactured into any form of
medicament, such as pill, capsule, powder, solution and pastil for
easy and convenient delivery to the subject in need.
[0051] In addition, the herbal extract can be administered to the
subject in need thereof. For example, the herbal composition can be
administered to the subject in need thereof in a dosage of 100
mg/per kilogram of body weight per day (100 mg/kg/day) for 15-60
days. Therefore, ferulic acid and polysaccharides rich in the
herbal composition poses synergistic effect in the subject in need
thereof, recovering the hyperglycemia-induced damages and relieving
symptoms of diabetic retinopathy.
[0052] In order to evaluate the herbal composition poses effect on
diabetic retinopathy, the following trials are carried out.
[0053] Trial (A): Manufacturing Procedure.
[0054] In trial (A), The root sample of Astragalus membranaceus (1
kg) is mixed with the root sample of Angelica sinensis (200 g),
followed by extracting with 95% ethanol (4 L) for 800 minutes. The
extraction process repeats for 3 times, and the resulting product
is vacuum filtrated, vacuum concentrated, and freeze-dried to
obtain 98.52 g of an extract mixture containing the ethanol extract
of Astragalus membranaceus and the ethanol extract of Angelica
sinensis.
[0055] On the other hand, water (4 L) is mixed with the stem sample
of Dendrobium officinale (1 kg), and heated to extract the stem
sample of Dendrobium officinale for 2 hours. The obtained solution
is vacuum concentrated (final volume to 1 L) and partitioned with
pre-cooled 95% ethanol (3L, 4.degree. C.) overnight. Then, 74.58 g
of the water extract of Dendrobium officinale (as the precipitate)
is obtained after by centrifugating at 12,000 rpm for 20 minutes
and removing the supernatant.
[0056] The extract mixture and the water extract of Dendrobium
officinale is mixed to obtain the herbal composition according to
the present invention, which includes 40 wt % of the ethanol
extract of Astragalus membranaceus, 8 wt % of the ethanol extract
of Angelica sinensis and 52 wt % of the water extract of Dendrobium
officinale.
[0057] Trial (B): Indicator Ingredients.
[0058] For analyzing ferulic acid, the herbal composition (1.608 g)
is dissolved in methanol, filtrated by the 0.45 .mu.m filter, and
adjusted the final volume to 10 mL. Moreover, Thermo ODS Hypersil
(5 .mu.m) 250 mm.times.4.6 mm column is used. A mobile phase is
acetonitrile and 0.05% phosphoric acid mixed in a volumetric ratio
of 18:82. A flow rate of the mobile phase is 1 mL/min. An
absorbance at 320 nm is used to determine the percentage of the
total area of ferulic acid. The content of ferulic acid calculated
according to the standard curve is 42.255.+-.5.655 .mu.g/g.
[0059] For analyzing polysaccharides, the phenol-sulfuric acid
method is carried out. In detail, the herbal composition is
dissolved in hot water in a concentration of 200 mg/100 mL. The
diluents with volume of 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL and
0.8 mL are mixed with phenol solution (1.times. volume, 5%), and
then subjected to 5.times. volume of a direct stream of
concentrated sulfuric acid. After cooling for 30 minutes,
absorbance at 490 nm is measured. The content of polysaccharides
calculated according to the standard curve is 14.667 .mu.g/g in a
form of glucose content per gram of the herbal composition.
[0060] Trial (C): Effects on Diabetic Retinopathy In Vivo.
[0061] Wistar male rats (6-8 week-old, weight 150-200 g) purchased
from The National Laboratory Animal Center (NLAC) are used in trial
(C). The rats are housed in an animal room in the Experimental
Animal Center of Tajen university with constant temperature of
24.+-.2.degree. C., with relative humidity of 65.+-.2%, where is
kept on a 12-hours light and 12-hours dark cycle. The rats are
housed and kept on free diet and water.
[0062] Rats with type I diabetes (groups C1-C4 shown in TABLE 1)
are induced by administration of streptozotocin (STZ, 60 mg/kg) via
intraperitioneal injection after fasting for 72 hours. Moreover,
after administration of STZ for 72 hours, the rats with type I
diabetes show blood sugar level higher than 300 mg/L and symptoms
including frequent urination, increased thirst and increased
hunger.
[0063] Referring to TABLE 1, rats of groups C2-C4 are orally
administered with the extract mixture containing the ethanol
extract of Astragalus membranaceus and the ethanol extract of
Angelica sinensis (group C2, 50 mg/kg/day), the water extract of
Dendrobium officinale (group C3, 50 mg/kg/day) and the herbal
composition (group C4, 100 mg/kg/day) for 60 days, respectively.
Intraocular pressure (TOP) and symptoms of diabetic retinopathy are
monitored on day 1, day 15, day 30, day 45 and day 60.
TABLE-US-00001 TABLE 1 Groups STZ induction Treatment (dosage per
day) C0 - Water (1 mL/kg) C1 + Water (1 mL/kg) C2 + Extract mixture
(50 mg/kg) C3 + Water extract of Dendrobium officinale (50 mg/kg)
C4 + Herbal composition (100 mg/kg)
[0064] The intraocular pressure of the rats of groups C0-C4 on day
1, day 15, day 30, day 45 and day 60 are monitored after
anesthetizing with diethyl ether, respectively. As shown in FIG. 1,
the intraocular pressure of group C1 remains about 20 mmHg after
day 15, while the intraocular pressure of group C4 (administered
with the herbal composition) is significantly decreased.
[0065] Moreover, fundus photography is carried with MiiS Horus
Scope DOC100 on day 1, day 15, day 30, day 45 and day 60, after
administrating of atropine (0.25%), followed by anesthetizing with
diethyl ether. Fundus photographs are shown as FIGS. 2a-2e (group
C0), 3a-3e (group C1), 4a-4e (group C2), 5a-5e (group C3) and 6a-6e
(group C4).
[0066] Referring to FIGS. 2a-2e, rats of group C0 show no symptoms
of diabetic retinopathy, while rats of group C1 show symptoms of
diabetic retinopathy, such as intraretinal microvascular
abnormalities (IRMA) and retinal hemorrhage after day 30 referring
to FIGS. 3a-3e. Moreover, referring to FIGS. 4a-4e and FIGS. 5a-5e,
although rats of groups C2 and C3 also show symptoms of diabetic
retinopathy, the symptoms of diabetic retinopathy is slighter than
the symptoms of diabetic retinopathy in rats of groups C1. Finally,
referring to FIGS. 6a-6e, rats of group C4, similar to rats of
group C0, show no symptoms of diabetic retinopathy. That is, the
herbal composition according to the present invention can be used
to relieve symptoms of diabetic retinopathy.
[0067] In summary, the herbal composition for diabetic retinopathy
according to the present invention, rich in indicator ingredients
such as ferulic acid and polysaccharides, is capable of relieving
symptoms of diabetic retinopathy, and therefore, the herbal
composition for diabetic retinopathy according to the present
invention can be used to slow or stop further vision loss.
[0068] Furthermore, the method according to the present invention
is a more acceptable, non-invasive treatment, by administering the
herbal composition rich in indicator ingredients such as ferulic
acid and polysaccharides, further preventing from side effects such
as steroid-induced disorders.
[0069] Although the invention has been described in detail with
reference to its presently preferable embodiment, it will be
understood by one of ordinary skill in the art that various
modifications can be made without departing from the spirit and the
scope of the invention, as set forth in the appended claims.
* * * * *