U.S. patent application number 17/379980 was filed with the patent office on 2021-11-11 for traditional chinese medicine composition for treating tumours, preparation method therefor and use thereof.
The applicant listed for this patent is Na ZHAO, Angang ZUO, Shixu ZUO. Invention is credited to Na ZHAO, Angang ZUO, Shixu ZUO.
Application Number | 20210346452 17/379980 |
Document ID | / |
Family ID | 1000005724943 |
Filed Date | 2021-11-11 |
United States Patent
Application |
20210346452 |
Kind Code |
A1 |
ZUO; Angang ; et
al. |
November 11, 2021 |
TRADITIONAL CHINESE MEDICINE COMPOSITION FOR TREATING TUMOURS,
PREPARATION METHOD THEREFOR AND USE THEREOF
Abstract
Disclosed are a traditional Chinese medicine composition for
treating tumours and a preparation method therefor, wherein the
composition is prepared from Sophora flavescens, wild Chrysanthemum
flower, honeysuckle, mint, Poria cocos, Atractylodes lancea,
cinnamon, clove, Astragalus, Ganoderma lucidum, Ligusticum
striatum, Aucklandia root and Radix glycyrrhizae. The traditional
Chinese medicine composition has an anti-tumour effect.
Inventors: |
ZUO; Angang; (Beijing,
CN) ; ZUO; Shixu; (Beijing, CN) ; ZHAO;
Na; (Beijing, CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ZUO; Angang
ZUO; Shixu
ZHAO; Na |
Beijing
Beijing
Beijing |
|
CN
CN
CN |
|
|
Family ID: |
1000005724943 |
Appl. No.: |
17/379980 |
Filed: |
July 19, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16462073 |
May 17, 2019 |
11065291 |
|
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PCT/CN2017/101223 |
Sep 11, 2017 |
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17379980 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 36/481 20130101;
A61K 36/355 20130101; A61P 35/00 20180101; A61K 36/074 20130101;
A61K 36/285 20130101; A61K 36/61 20130101; A61K 36/287 20130101;
A61K 36/54 20130101; A61K 36/236 20130101; A61K 36/534 20130101;
A61K 36/484 20130101; A61K 36/284 20130101 |
International
Class: |
A61K 36/481 20060101
A61K036/481; A61P 35/00 20060101 A61P035/00; A61K 36/074 20060101
A61K036/074; A61K 36/236 20060101 A61K036/236; A61K 36/284 20060101
A61K036/284; A61K 36/285 20060101 A61K036/285; A61K 36/287 20060101
A61K036/287; A61K 36/355 20060101 A61K036/355; A61K 36/484 20060101
A61K036/484; A61K 36/534 20060101 A61K036/534; A61K 36/54 20060101
A61K036/54; A61K 36/61 20060101 A61K036/61 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 13, 2017 |
CN |
201710147162.1 |
Claims
1. A medicinal composition for treating tumors, wherein the
medicinal composition is prepared by the combination of extractions
of the following raw materials: Sophora flavescens, wild
Chrysanthemum flower, honeysuckle, mint, Poria cocos, Atractylodes
lancea, cinnamon, clove, Astragalus, Ganoderma lucidum, Ligusticum
striatum, Aucklandia root, and Radix glycyrrhizae.
2. The medicinal composition of claim 1, wherein a dosage form of
the medicinal composition is a pill, a capsule, a tablet, a gel, or
a film.
3. The medicinal composition of claim 1, wherein weight percentages
of the raw materials are: Sophora flavescens 3%-12%, wild
Chrysanthemum flower 5%-15%, honeysuckle 2%-12%, mint 5%-15%, Poria
cocos 5%-15%, Atractylodes lancea 10%-20%, cinnamon 0.5%-3%, clove
0.5%-3%, Astragalus 3%-12%, Ganoderma lucidum 5%-15%, Ligusticum
striatum 10%-20%, Aucklandia root 5%-12%, and Radix glycyrrhizae
2%-10%.
4. A preparation method of the medicinal composition according to
claim 1, wherein the preparation method comprises: step (1),
obtaining the raw materials, crushing and sieving the crushed raw
materials respectively, and mixing uniformly to obtain a powder;
step (2), preparing ethanol solution, infiltrating the powder
prepared from step (1) with the ethanol solution, and adding the
infiltrated powder into a percolator; step (3), adding more of the
ethanol solution to the percolator from step (2) to soak the
infiltrated powder, after soaking, obtaining alcohol percolate by
performing percolation, obtaining drug residues after percolation,
and obtaining a medicinal compound powder A by concentrating and
drying the obtained alcohol percolate; step (4), decocting the drug
residues obtained from step (3) with water, obtaining filtrate of
the decocted drug residues by filtrating, and obtaining a medicinal
compound powder B by concentrating and drying the obtained filtrate
of the decocted drug residues; and step (5), uniformly mixing the
medicinal compound powder A obtained from step (3) and the
medicinal compound powder B obtained from step (4) to obtain the
medicinal composition.
5. The preparation method of the medicinal composition according to
claim 4, wherein in step (1), the size of the crushed raw materials
is 10-100 mesh; in step (2) and step (3), the concentration of the
ethanol solution is 40-95%; in step (2), the infiltrating time is
10-48 hours; in step (3), the soaking time is 2-48 hours; and in
step (4), the amount of water is 2-10 times of the drug residues,
and the decoction is 1-3 times, each time for 0.5-2 hours.
6. A preparation method of the medicinal composition according to
claim 1, wherein the preparation method comprises: step (1),
obtaining the raw materials, crushing the raw materials to 10-100
mesh, sieving the crushed raw materials, and uniformly mixing the
sieved raw materials to obtain a uniformly mixed powder; step (2),
preparing an ethanol solution with a concentration of 40-95% for
use; infiltrating the uniformly mixed powder with the ethanol
solution for 10-48 hours, and adding the infiltrated powder into a
percolator and gently pressing and flattening the infiltrated
powder; step (3), adding the ethanol solution into the percolator
from step (2) till beyond the surface of the raw materials 1-2 cm,
soaking for a preset time, obtaining alcohol percolate by
performing percolation, reserving drug residues for use, and
obtaining a medicinal compound powder A by concentrating under
pressure and drying the obtained alcohol percolate; and step (4),
adding 2-10 times of the drug residues amount of water to the drug
residues, decocting for 0.5-2 hours, centrifuging and filtrating,
obtaining a medicinal compound powder B by concentrating and drying
under reduced pressure, and obtaining the medicinal composition by
uniformly mixing the medicinal compound powder A and the medicinal
compound powder B.
7. The preparation method of the medicinal composition according to
claim 6, wherein in step (1), the size of the crushed raw materials
is 20-40 mesh; in step (2) and step (3), the concentration of the
ethanol solution is 60-80%; in step (2), infiltrating the uniformly
mixed powder for 18-30 hours; and in step (3), the soaking time is
2-48 hours.
8. A preparation method of the medicinal composition according to
claim 1, wherein the preparation method comprises: step (1),
obtaining first medicinal materials including Ligusticum striatum,
Atractylodes lancea, Aucklandia root, clove, cinnamon, and mint,
extracting volatile oil and obtaining decocted residues by
decocting the first medicinal materials with water, processing the
extracted volatile oil with cyclodextrin to obtain a volatile oil
cyclodextrin inclusion complex, and filtrating the decocted
residues to obtain first filtrate and drug residues for later use;
step (2), mixing the drug residues obtained from step (1) with
second medicinal materials including Poria cocos, Astragalus, wild
Chrysanthemum flower, Ganoderma lucidum, honeysuckle, Sophora
flavescens, and Radix glycyrrhizae, decocting the mixed drug
residues and the second medicinal materials with water and then
filtrating to obtain second filtrate, and combining the second
filtrate with the first filtrate obtained from step (1) to obtain a
medicinal mixed solution; step (3), concentrating the medicinal
mixed solution obtained from step (2) to paste, adding ethanol to
the paste to make the paste precipitating in ethanol, and obtaining
a mixed alcohol solution by filtration; and step (4), concentrating
and drying the mixed alcohol solution obtained from step (3),
adding the volatile oil cyclodextrin inclusion complex from step
(1) to obtain the medicinal composition.
9. The preparation method of the medicinal composition according to
claim 8, wherein in step (1), the amount of water used in decocting
process is 4-15 times of the amount of the first medicinal
materials, the extraction time is 2-12 hours, the volatile oil is
processed with a cyclodextrin inclusion process below 40.degree.
C., and a time of the cyclodextrin inclusion process is 1-10 hours;
step (2) further comprises: mixing the drug residues obtained from
step (1) with the second medicinal materials including Poria cocos,
Astragalus, wild Chrysanthemum flower, Ganoderma lucidum,
honeysuckle, Sophora flavescens, and Radix glycyrrhizae, adding
10-15 times of the amount of the second medicinal materials of
water and decocting for 2-5 times, each time for 1-2 hours, and
then filtrating to obtain the second filtrate, and mixing the
second filtrate with the first filtrate obtained from step (1) to
obtain the medicinal mixed solution; and step (3) further
comprises: concentrating the medicinal mixed solution obtained from
step (2) by water bath to the paste with a density of 1.06-1.08
g/cm.sup.3, adding ethanol to make the ethanol content up to 60%,
standing still for 12-72 hours, and filtrating to obtain the mixed
alcohol solution.
10. A preparation method of the medicinal composition according to
claim 1, wherein the preparation method comprises: step (1),
obtaining first medicinal materials including Ligusticum striatum,
Atractylodes lancea, Aucklandia root, clove, cinnamon, and mint,
extracting volatile oil and obtaining decocted residues by
decocting the first medicinal materials with water, processing the
extracted volatile oil with cyclodextrin to obtain a volatile oil
cyclodextrin inclusion complex, and filtrating the decocted
residues to obtain first filtrate and drug residues for later use;
step (2), mixing the drug residues with second medicinal materials
including Poria cocos, Astragalus, wild Chrysanthemum flower,
Ganoderma lucidum, honeysuckle, Sophora flavescens, and Radix
glycyrrhizae, decocting the mixed drug residues and the second
medicinal materials with water and then filtrating to obtain second
filtrate, and combining the second filtrate with the first filtrate
obtained from step (1) to obtain a medicinal mixed solution; step
(3), concentrating the medicinal mixed solution to paste by water
bath, adding ethanol to the paste to make the paste precipitating
in ethanol, adding ethanol to make the ethanol content up to 50-80%
to obtain a medicinal mixed alcohol solution; and step (4),
concentrating the medicinal mixed alcohol solution under reduced
pressure, drying, adding the volatile oil cyclodextrin inclusion
complex to obtain the medicinal composition.
11. The preparation method of the medicinal composition according
to claim 10, wherein in step (1), the amount of water used in
decocting process is 4-15 times of the amount of the first
medicinal materials, the extraction time is 2-12 hours, the
volatile oil is processed with cyclodextrin below 40.degree. C.,
and a time of the cyclodextrin inclusion process is 1-10 hours.
12. The preparation method of the medicinal composition according
to claim 10, wherein the step (2) further comprises: mixing the
drug residues obtained from step (1) with the second medicinal
materials including Poria cocos, Astragalus, wild 25 Chrysanthemum
flower, Ganoderma lucidum, honeysuckle, Sophora flavescens, and
Radix glycyrrhizae, adding 10-15 times of the amount of the second
medicinal materials of water and decocting for 2-5 times, each time
for 1-2 hours, and then filtrating to obtain the second filtrate,
and mixing the second filtrate with the first filtrate obtained
from step (1) to obtain the medicinal mixed solution.
13. The preparation method of the medicinal composition according
to claim 10, wherein the step (3) further comprises: concentrating
the medicinal mixed solution by water bath to the paste with a
density of 1.06-1.08 g/cm.sup.3, adding ethanol to make the ethanol
content up to 60%, and standing still for 12 hours or more to
obtain the medicinal mixed alcohol solution.
14. A preparation method of the medicinal composition according to
claim 1, wherein the preparation method comprises: step (1),
obtaining each of the raw materials, and mixing uniformly; and step
(2), adding ethanol solution into the uniformly mixed raw materials
from step (1), obtaining extract solution by heating and refluxing
for 1-2 hours, performing the above part of step (2) for 1-4 times,
merging the extract solution of each refluxing process, recovering
the ethanol under reduced pressure, and concentrating and drying to
obtain the medicinal composition.
15. A preparation method of the medicinal composition according to
claim 1, wherein the preparation method comprises: step (1),
obtaining the raw materials and mixing uniformly; and step (2),
preparing 40-80% ethanol solution for use, adding the uniformly
mixed raw materials into the prepared ethanol solution, obtaining
extract solution by heating and refluxing for 1-2 hours, performing
the above part of step (2) for 1-4 times, merging the extract
solution, recovering the ethanol under reduced pressure, and
concentrating and drying to obtain the medicinal composition.
16. A method for treating tumors, comprising: administering the
medicinal composition according to claim 1 to a subject suffering
from tumor.
17. The medicinal composition of claim 1, wherein the medicinal
composition is used for treating a tumor.
18. A medicinal composition for treating tumors, wherein the
medicinal composition is prepared by combining at least one of
percolate extractions, volatile oil extractions, decocting
extractions, and refluxing extractions of the following raw
materials: Sophora flavescens, wild Chrysanthemum flower,
honeysuckle, mint, Poria cocos, Atractylodes lancea, cinnamon,
clove, Astragalus, Ganoderma lucidum, Ligusticum striatum,
Aucklandia root, and Radix glycyrrhizae.
19. The medicinal composition of claim 18, wherein a dosage form of
the medicinal composition is a pill, a capsule, a tablet, a gel, or
a film.
20. A preparation method of a medicinal composition, wherein the
preparation method comprises: step (1), obtaining a mixing powder
of raw materials, wherein the raw materials includes Sophora
flavescens, wild Chrysanthemum flower, honeysuckle, mint, Poria
cocos, Atractylodes lancea, cinnamon, clove, Astragalus, Ganoderma
lucidum, Ligusticum striatum, Aucklandia root, and Radix
glycyrrhizae; step (2), preparing ethanol solution, infiltrating
the powder prepared from step (1) with the ethanol solution, and
adding the infiltrated powder into a percolator; step (3), adding
more of the ethanol solution to the percolator from step (2) to
soak the infiltrated powder, after soaking, obtaining alcohol
percolate by performing percolation, obtaining drug residues after
percolation, and obtaining a medicinal compound powder A by
concentrating and drying the obtained alcohol percolate; step (4),
decocting the drug residues obtained from step (3) with water,
obtaining filtrate of the decocted drug residues by filtrating, and
obtaining a medicinal compound powder B by concentrating and drying
the obtained filtrate of the decocted drug residues; and step (5),
uniformly mixing the medicinal compound powder A obtained from step
(3) and the medicinal compound powder B obtained from step (4) to
obtain the medicinal composition.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 16/462,073 filed on May 17, 2019, which is a
U.S. national stage application of International Application No.
PCT/CN2017/101223 filed on Sep. 11, 2017, which claims priority to
Chinese Application No. 201710147162.1 filed on Mar. 13, 2017, the
entire contents each of which are incorporated herein by
reference.
TECHNICAL FIELD
[0002] The present disclosure belongs to the field of traditional
Chinese medicines, and relates to a traditional Chinese medicine
composition for treating tumors, preparation method thereof and use
thereof.
BACKGROUND
[0003] Currently, the treatment of the malignant tumors mainly
adopts surgical treatment, chemotherapy or radiotherapy and so on,
among them, surgical treatment has difficult postoperative
recovery, and chemotherapy and radiotherapy have harmful side
effects.
[0004] In the existing treatments of malignant tumors, the
anti-tumor drug market has grown in recent years. Since tumor
patients have increased year by year and most anti-tumor drugs have
more toxic side effects, development of an anti-cancer drug with
obvious effect and small side effects has an important
implication.
SUMMARY
[0005] In one aspect, the present disclosure provides a traditional
Chinese medicine composition for treating tumors. In another
aspect, the present disclosure provides a preparation method of the
traditional Chinese medicine composition for treating tumors. In
further another aspect, the present disclosure provides a use of
the traditional Chinese medicine composition for treating tumors
and a method for treating tumors.
[0006] The traditional Chinese medicine composition for treating
tumors of the present disclosure is prepared by raw materials with
weight percentage as follows: Sophora flavescens 3%-12%, wild
Chrysanthemum flower 5%-15%, honeysuckle 2%-12%, mint 5%-15%, Poria
cocos 5%-15%, Atractylodes lancea 10%-20%, cinnamon 0.5%-3%, clove
0.5%-3%, Astragalus 3%-12%, Ganoderma lucidum 5%-15%, Ligusticum
striatum 10%-20%, Aucklandia root 5%-12%, and Radix glycyrrhizae
2%-10%.
[0007] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 5%-10%, wild
Chrysanthemum flower 5%-10%, honeysuckle 3%-8%, mint 5%-10%, Poria
cocos 5%-10%, Atractylodes lancea 12%-20%, cinnamon 0.5%-3%, clove
0.5%-3%, Astragalus 5%-10%, Ganoderma lucidum 5%-10%, Ligusticum
striatum 11%-15%, Aucklandia root 8%-12%, and Radix glycyrrhizae
3%-8%.
[0008] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 6%-10%, wild
Chrysanthemum flower 6%-9%, honeysuckle 3%-6%, mint 6%-9%, Poria
cocos 6%-9%, Atractylodes lancea 15%-18%, cinnamon 1%-3%, clove
0.5%-1.5%, Astragalus 6%-10%, Ganoderma lucidum 6%-10%, Ligusticum
striatum 12%-15%, Aucklandia root 8%-11%, and Radix glycyrrhizae
3%-6%.
[0009] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 8%, wild
Chrysanthemum flower 9%, honeysuckle 4%, mint 6%, Poria cocos 6%,
Atractylodes lancea 17%, cinnamon 2%, clove 1%, Astragalus 8%,
Ganoderma lucidum 10%, Ligusticum striatum 13%, Aucklandia root 9%,
and Radix glycyrrhizae 7%.
[0010] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 7%, wild
Chrysanthemum flower 7%, honeysuckle 6%, mint 8%, Poria cocos 8%,
Atractylodes lancea 15%, cinnamon 2%, clove 1.5%, Astragalus 7%,
Ganoderma lucidum 8%, Ligusticum striatum 15%, Aucklandia root 10%,
and Radix glycyrrhizae 5.5%.
[0011] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 8%, wild
Chrysanthemum flower 7%, honeysuckle 5%, mint 6%, Poria cocos 9%,
Atractylodes lancea 18%, cinnamon 1.5%, clove 0.5%, Astragalus 6%,
Ganoderma lucidum 9%, Ligusticum striatum 16%, Aucklandia root 9%,
and Radix glycyrrhizae 5%.
[0012] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 6%, wild
Chrysanthemum flower 9%, honeysuckle 8%, mint 5%, Poria cocos 9%,
Atractylodes lancea 19%, cinnamon 1%, clove 1%, Astragalus 6%,
Ganoderma lucidum 15%, Ligusticum striatum 11%, Aucklandia root 9%,
and Radix glycyrrhizae 10%.
[0013] In one embodiment, the traditional Chinese medicine
composition for treating tumors is prepared by raw materials with
weight percentage as follows: Sophora flavescens 9%, wild
Chrysanthemum flower 8%, honeysuckle 3%, mint 9%, Poria cocos 8%,
Atractylodes lancea 16.5%, cinnamon 1%, clove 1%, Astragalus 9%,
Ganoderma lucidum 9%, Ligusticum striatum 13.5%, Aucklandia root
10%, and Radix glycyrrhizae 3%.
[0014] In one embodiment, the dosage form of the traditional
Chinese medicine composition for treating tumors is an injection, a
honeyed pill, a water pill, a capsule, a tablet, a dripping pill, a
powder, an oral solution, a gel, an electuary, an extract or a
film.
[0015] In one aspect, the present disclosure provides the
preparation method of the traditional Chinese medicine composition
for treating tumors including the following steps:
[0016] Step (1), weighed the raw materials according to the weight
percentage, crushed the raw materials and uniformly mixed after
sieved.
[0017] Step (2), infiltrated the traditional Chinese medicine
powder obtained from step (1) into ethanol, and poured into a
percolator.
[0018] Step (3), poured ethanol into the percolator, and processing
percolation after soak; prepared the drug residues obtained after
percolation for later use, and obtained a traditional Chinese
medicine compound powder A by concentrating and drying the obtained
alcohol percolate.
[0019] Step (4), decocted the drug residues obtained from step (3)
with water, filtrated, and obtained a traditional Chinese medicine
compound powder B by concentrating and drying.
[0020] Step (5), uniformly mixed the traditional Chinese medicine
compound powder A from step (3) and the traditional Chinese
medicine compound powder B from step (4) to obtain the traditional
Chinese medicine composition.
[0021] In one preferred embodiment, in step (1), the size of the
crushed raw materials is 10-100 mesh, preferably 20-40 mesh, most
preferably 24 mesh.
[0022] In another preferred embodiment, in step (2) and step (3),
the concentration of ethanol is 40-95%, preferably 60-80%, most
preferably 70%.
[0023] In another preferred embodiment, in step (2), the uniformly
mixed traditional Chinese medicine powder was infiltrated for 10-48
hours, preferably for 18-30 hours, most preferably 24 hours.
[0024] In another preferred embodiment, in step (3), the soaking
time is 2-48 hours, preferably 18-36 hours.
[0025] In another preferred embodiment, in step (4), the amount of
water is 2-10 times of the drug residues, and the decoction is 1-3
times, each time for 0.5-2 hours.
[0026] In one embodiment, the preparation method of the traditional
Chinese medicine composition for treating tumors including the
following steps:
[0027] Step (1), weighed the raw materials according to the weight
percentage, crushed the raw materials to 10-100 mesh and uniformly
mixed after sieved.
[0028] Step (2), prepared a 40-95% ethanol; infiltrated the
traditional Chinese medicine powder obtained from step (1) into the
40-95% ethanol for 10-48 hours, and poured into a percolator and
gently paved.
[0029] Step (3), the prepared ethanol solution having a
concentration of 40-95% is added into the percolator in the step
(2) and added to the surface of the raw materials 1-2 cm. After
soaking for a preset time, the remaining ethanol is percolation,
and the drug residues are reserved, the obtained alcohol liquid is
concentrated under pressure, and dried to obtain a traditional
Chinese medicine compound powder A.
[0030] Step (4), added 2-10 times of the drug residues amount of
water to the drug residues, decoction extracting for 0.5-2 hours,
centrifuged and filtrated, and obtained a traditional Chinese
medicine compound powder B by concentrated and dried under reduced
pressure, and obtained the traditional Chinese medicine composition
by uniformly mixing the traditional Chinese medicine compound
powder A and the traditional Chinese medicine compound powder
B.
[0031] In one preferred embodiment, in step (1), the size of the
crushed raw materials is 20-40 mesh, most preferably 24 mesh; in
step (2) and step (3), the concentration of ethanol is 60-80/a,
most preferably 70%.
[0032] In one preferred embodiment, in step (2), the uniformly
mixed traditional Chinese medicine powder was infiltrated for 18-30
hours, most preferably 24 hours; and, in step (3), the soaking time
is 2-48 hours, preferably 18-36 hours.
[0033] In one aspect, the present disclosure further provides the
preparation method of the traditional Chinese medicine composition
for treating tumors including the following steps:
[0034] Step (1), weighed Ligusticum striatum, Atractylodes lancea,
Aucklandia root, clove, cinnamon, and mint according to the weight
percentage, extracting volatile oil by water, and processed the
extracted volatile oil with cyclodextrin to obtain a volatile oil
cyclodextrin inclusion complex. After filtration, the water
decoction, the collecting the filtrate and the drug residues were
collected for later use.
[0035] Step (2), mixed the drug residues obtained from step (1)
after extracting the volatile oil with weighed Poria cocos,
Astragalus, wild Chrysanthemum flower, Ganoderma lucidum,
honeysuckle, Sophora flavescens, and Radix glycyrrhizae, according
to the weight percentage, decocting with water and then filtrating,
and combining the filtrate of decoction with the filtrate obtained
after extracting the volatile oil to obtain a traditional Chinese
medicine mixed solution.
[0036] Step (3), concentrated the traditional Chinese medicine
mixed solution to paste, precipitated with ethanol, and a
traditional Chinese medicine mixed alcohol solution being obtained
after filtration.
[0037] Step (4), after concentration and drying the traditional
Chinese medicine mixed alcohol solution, added the volatile oil
cyclodextrin inclusion complex, so as to obtain the traditional
Chinese medicine composition.
[0038] In certain embodiments, the amount of water used in volatile
oil extraction is 4-15 times than the medicine materials,
preferably 4-8 times, most preferably 6 times, extraction time is
2-12 hours, and the volatile oil is processed with a cyclodextrin
inclusion process under 40.degree. C. for 1-10 hours, preferably
2-8 hours, most preferably 6 hours.
[0039] In certain embodiments, step (2) further includes mixing the
drug residues obtained by extracting the volatile oil extraction
with weighed Poria cocos, Astragalus, wild Chrysanthemum flower,
Ganoderma lucidum, honeysuckle, Sophora flavescens, and Radix
glycyrrhizae, according to the weight percentage, adding 10-15
times of the amount of water and decocting for 2-5 times, each
times for 1-2 hours, and then filtrating, and mixing the filtrate
of decoction and the filtrate obtained after extracting the
volatile oil to obtain the traditional Chinese medicine mixed
solution.
[0040] In certain embodiments, step (3) further includes
concentrating the traditional Chinese medicine mixed solution from
step (2) by water bath, concentrated to a relative density of
1.06-1.08 paste, adding ethanol to make the ethanol content up to
60%, standing still for 12-72 hours, and filtrating to obtain the
traditional Chinese medicine mixed alcohol solution.
[0041] In certain embodiments, the preparation method of the
traditional Chinese medicine composition for treating tumors
including the following steps:
[0042] Step (1), weighed Ligusticum striatum, Atractylodes lancea,
Aucklandia root, clove, cinnamon, and mint according to the weight
percentage, extracted volatile oil by water, and processed the
extracted volatile oil with cyclodextrin to obtain a volatile oil
cyclodextrin inclusion complex, filtrating the water decoction and
the collected the filtrate and the drug residues for later use.
[0043] Step (2), mixed the drug residues obtained by extracting the
volatile oil with weighed Poria cocos, Astragalus, wild
Chrysanthemum flower, Ganoderma lucidum, honeysuckle, Sophora
flavescens, and Radix glycyrrhizae, according to the weight
percentage, decocted with water and then filtrated, and combined
the filtrate of decoction with the filtrate obtained after
extracting the volatile oil to obtain a traditional Chinese
medicine mixed solution.
[0044] Step (3), concentrated the traditional Chinese medicine
mixed solution to paste by water bath, precipitating with ethanol,
adding alcohol to make the ethanol content up to 50-80% and to
obtain a traditional Chinese medicine mixed alcohol solution.
[0045] Step (4), concentrated the traditional Chinese medicine
mixed alcohol solution under reduced pressure, after dried, and
added the volatile oil cyclodextrin inclusion complex, so as to
obtain the traditional Chinese medicine composition.
[0046] In certain embodiments, in step (1), the amount of water
used in volatile oil extraction is 4-15 times than the medicine
materials, and the volatile oil is processed with cyclodextrin
under 40.degree. C. for 1-10 hours.
[0047] In certain embodiments, step (2) further includes mixing the
drug residues obtained by extracting the volatile oil extraction
with weighed Poria cocos, Astragalus, wild Chrysanthemum flower,
Ganoderma lucidum, honeysuckle, Sophora flavescens, and Radix
glycyrrhizae, according to the weight percentage, adding 10-15
times of the amount of water and decocting for 2-5 times, each
times for 1-2 hours, and then filtrating, and mixing the filtrate
of decoction and the filtrate obtained after extracting the
volatile oil to obtain the traditional Chinese medicine mixed
solution.
[0048] In certain embodiments, step (3) further includes
concentrating the traditional Chinese medicine mixed solution from
step (2) by water bath, concentrated to a relative density of
1.06-1.08 paste, adding ethanol to make the ethanol content up to
60%, standing still for 12 hours or more, and filtrating to obtain
the traditional Chinese medicine mixed alcohol solution.
[0049] In certain embodiments, the preparation method of the
traditional Chinese medicine composition for treating tumors
including the following steps:
[0050] Step (1), weighed the raw materials according to the weight
percentage, and mixing uniformly.
[0051] Step (2), added ethanol solution into the uniformly mixed
raw materials from step (1), preferably 40-80% ethanol, heating and
refluxing for 1-4 times, each time for 1-2 hours, merging the
extracts, recovering the ethanol under reduced pressure, and
concentrating and drying to obtain the traditional Chinese medicine
composition.
[0052] In certain embodiments, in step (2), the concentration of
ethanol is 50-70%, most preferably 60%.
[0053] In certain embodiments, the preparation method of the
traditional Chinese medicine composition for treating tumors
including the following steps:
[0054] Step (1), weighed the raw materials according to the weight
percentage.
[0055] Step (2), prepared 40-80% ethanol for use, added the
uniformly mixed traditional Chinese medicine into the he prepared
ethanol solution, heating and refluxing for 1-4 times, each time
for 1-2 hours, merging the extracts, recovering the ethanol under
reduced pressure, and concentrating and drying to obtain the
traditional Chinese medicine composition.
[0056] In certain embodiments, in step (2), the concentration of
the prepared ethanol is 50-70%, most preferably 60%.
[0057] In one aspect, the present disclosure provides a use of the
traditional Chinese medicine composition for treating tumors for
the preparation of a medicament for treating tumors.
[0058] In one aspect, the present disclosure provides a method for
treating tumor, and the traditional Chinese medicine composition
for treating tumors of the present disclosure is administered to a
subject in need thereof.
[0059] In one aspect, the present disclosure provides a traditional
Chinese medicine composition for treating tumors for use in
treating a tumor.
[0060] The main active ingredient of the traditional Chinese
medicine composition is Sophora flavescens, providing with the
effect of "bitter and cold", and "heat and dampness". The effect
"bitter and cold" of Sophora flavescens can relive fever, reduce
the diarrhea and clean up the muggy in body which caused by moist
and hot weather. The secondary active ingredients are wild
Chrysanthemum flower, honeysuckle, mint, Poria cocos, and
Atractylodes lancea, which enhance the effect of "bitter and cold".
Among them, wild Chrysanthemum flower, honeysuckle, and mint can
eliminate cold and fever, so as to remove the heat-toxicity from
the lung; Poria cocos and Atractylodes lancea provide with the
effect can strengthen the spleen and remove dampness to clean up
the damp in spleen and stomach. However, the "yang-qi" would weak
while removing the damp heat, so that cinnamon and clove were added
as heat supply to regulate the "bitter and cold" and to prevent the
weaken "yang-qi". Astragalus and Ganoderma lucidum can boost "qi"
and strengthen healthy energy to strengthen body resistance. In
addition, the effect of "warming yang-qi" and strengthen healthy
energy used together can prevent the harmful of spleen and stomach
result from the excessive "bitter and cold". Ligusticum striatum
and Aucklandia root can promote blood circulation and activate
"qi", and thus the blocked dampness and the heat-toxicity can be
removed via circulation. Therefore, cinnamon, clove, Astragalus,
Ganoderma lucidum, Ligusticum striatum, and Aucklandia root are
adjuvants. Radix glycyrrhizae was used for regulating ingredients
and adjuvants, and has the effect of boosting "qi", consolidation
of exterior and warming spleen and stomach.
[0061] The remarkable anti-tumor efficacy of the traditional
Chinese medicine composition of the present disclosure was
confirmed by the rat and mice model of pharmacodynamic test. The
traditional Chinese medicine composition has the effect of
enhancing the immune function and anti-tumor. In addition, the raw
materials of the traditional Chinese medicine composition are easy
to obtain, the preparation method is simple, and the cost is
relatively low.
DETAILED DESCRIPTION
First Embodiment
[0062] A traditional Chinese medicine composition for treating
tumors including a material prepared by raw materials with weight
percentage as follows: Sophora flavescens 8%, wild Chrysanthemum
flower 9%, honeysuckle 4%, mint 6%, Poria cocos 6%, Atractylodes
lancea 17%, cinnamon 2%, clove 1%, Astragalus 8%, Ganoderma lucidum
10%, Ligusticum striatum 13%, Aucklandia root 9%, and Radix
glycyrrhizae 7%.
[0063] The preparation method of the traditional Chinese medicine
composition includes the following steps. According to the weight
percentage described above, the weighed raw materials were crushed
to particle size and uniformly mixed after sieved to 20 mesh. A 70%
ethanol solution was prepared for later use. Infiltrated the
uniformly mixed raw materials into the 70% ethanol solution for at
least 24 hours, poured the mixture into a percolator, and then
gently pave the mixture. The 70% ethanol solution was added into
the percolator and higher than the surface of the raw materials 1-2
cm, soaking for 18-30 hours (optimally, for 20 hours). Percolated
the ethanol and retain the drug residues for later use. The
percolated ethanol was concentrated under reduced pressure and
dried to obtain traditional Chinese medicine compound powder A. The
drug residues were added into water which the amount was twice to
10 times (most preferably, 8 times) than the drug residues thereof,
and decocted for 0.5-2 hours. After centrifugation and filtration,
the drug solution was concentrated under reduced pressure and dried
to obtain traditional Chinese medicine compound powder B. Uniformly
mixed the traditional Chinese medicine compound powder A and the
traditional Chinese medicine compound powder B to obtain the
traditional Chinese medicine composition.
Second Embodiment
[0064] A traditional Chinese medicine composition for treating
tumors including a material prepared by raw materials with weight
percentage as follows: Sophora flavescens 7%, wild Chrysanthemum
flower 7%, honeysuckle 6%, mint 8%, Poria cocos 8%, Atractylodes
lancea 15%, cinnamon 2%, clove 1.5%, Astragalus 7%, Ganoderma
lucidum 8%, Ligusticum striatum 15%, Aucklandia root 10%, and Radix
glycyrrhizae 5.5%.
[0065] The preparation method of the traditional Chinese medicine
composition includes the following steps. Weighed Ligusticum
striatum, Atractylodes lancea, Aucklandia root, clove, cinnamon,
and mint according to the weight percentage, and added appropriate
amount of extraction solvent to extract volatile oil, the
extraction solvent is 6 times the amount of the medicinal
materials, extract time is 2-20 hours (optimally 10 hours), and the
volatile oil was processed with cyclodextrin under 40'C to obtain a
volatile oil cyclodextrin inclusion complex. The time of
cyclodextrin inclusion process was 6 hours. The filtrate after the
volatile oil extraction was collected for later use. The drug
residues after the volatile oil extraction was mixed with weighed
Poria cocos, Astragalus, wild Chrysanthemum flower, Ganoderma
lucidum, honeysuckle, Sophora flavescens, and Radix glycyrrhizae,
according to the weight percentage, and added into water which
amount was 10-15 times (optimally, 12 times) than the drug residues
and the medicinal materials thereof, and decocted for 2-5 times
(optimally 3 times), and each time for 1-2 hours (optimally 1.5
hours). Filtered the decocted drug solution and mixed the drug
solution with the filtrate after the volatile oil extraction to
obtain a traditional Chinese medicine mixed solution. The
traditional Chinese medicine mixed solution was concentrated by
water bath and concentrated to the relative density of 1.06-1.08
paste, and then added ethanol containing alcohol amounted to 60%,
stand still for 12 hours or more to obtain a traditional Chinese
medicine mixed alcohol solution. The traditional Chinese medicine
mixed alcohol solution was concentrated under reduced pressure,
dried, and added with the volatile oil cyclodextrin inclusion
complex, so as to obtain the traditional Chinese medicine
composition.
Third Embodiment
[0066] A traditional Chinese medicine composition for treating
tumors including a material prepared by raw materials with weight
percentage as follows: Sophora flavescens 8%, wild Chrysanthemum
flower 7%, honeysuckle 5%, mint 6%, Poria cocos 9%, Atractylodes
lancea 18%, cinnamon 1.5%, clove 0.5%, Astragalus 6%, Ganoderma
lucidum 9%, Ligusticum striatum 16%, Aucklandia root 9%, and Radix
glycyrrhizae 5%.
[0067] The preparation method of the traditional Chinese medicine
composition includes the following steps. Weighed the raw materials
according to the weight percentage described above. A 60% ethanol
solution was prepared for later use. Soaked the uniformly mixed raw
materials into the 60% ethanol solution, which was 6 times the
amount of the raw materials thereof. The mixture was heated under
reflux for 2 times (heated to lightly boiling for reflux
extraction) for 1-2 hours (optimally 1.5 hours), and twice of the
extracts were merged, and the ethanol was recovered under reduced
pressure, followed by concentration and drying to obtain the
traditional Chinese medicine composition.
Fourth Embodiment
[0068] A traditional Chinese medicine composition for treating
tumors including a material prepared by raw materials with weight
percentage as follows: Sophora flavescens 6%, wild Chrysanthemum
flower 9%, honeysuckle 8%, mint 5%, Poria cocos 9%, Atractylodes
lancea 19%, cinnamon 1%, clove 1%, Astragalus 6%, Ganoderma lucidum
15%, Ligusticum striatum 11%, Aucklandia root 9%, and Radix
glycyrrhizae 10%.
[0069] The preparation method of the traditional Chinese medicine
composition includes the following steps. According to the weight
percentage described above, the weighed raw materials were crushed
to particle size and uniformly mixed after sieved to 30 mesh. A 65%
ethanol solution was prepared for later use. Infiltrated the
uniformly mixed raw materials into the 65% ethanol solution for 36
hours, poured the mixture into a percolator, and then gently pave
the mixture. The 65% ethanol solution was added into the percolator
and higher than the surface of the raw materials 1-2 cm, soaking
for 18 hours. Percolated the ethanol and retain the drug residues
for later use. The percolated ethanol was concentrated under
reduced pressure and dried to obtain traditional Chinese medicine
compound powder A. The drug residues were added into water which
the amount was 5 times than the drug residues thereof and decocted
for 1-2 hours (optimally 1.5 hours). After centrifugation and
filtration, the drug solution was concentrated under reduced
pressure and dried to obtain traditional Chinese medicine compound
powder B. Uniformly mixed the traditional Chinese medicine compound
powder A and the traditional Chinese medicine compound powder B to
obtain the traditional Chinese medicine composition.
Fifth Embodiment
[0070] A traditional Chinese medicine composition for treating
tumors including a material prepared by raw materials with weight
percentage as follows: Sophora flavescens 9%, wild Chrysanthemum
flower 8%, honeysuckle 3%, mint 9%, Poria cocos 8%, Atractylodes
lancea 16.5%, cinnamon 1%, clove 1%, Astragalus 9%, Ganoderma
lucidum 9%, Ligusticum striatum 13.5%, Aucklandia root 10%, and
Radix glycyrrhizae 3%.
[0071] The preparation method of the traditional Chinese medicine
composition includes the following steps. Weighed Ligusticum
striatum, Atractylodes lancea, Aucklandia root, clove, cinnamon,
and mint according to the weight percentage, and added appropriate
amount of extraction solvent to extract volatile oil, the
extraction solvent is 4 times the amount of the medicinal
materials, extract time is 2-12 hours (optimally 10 hours), and the
volatile oil was processed with cyclodextrin under 40.degree. C. to
obtain a volatile oil cyclodextrin inclusion complex. The time of
cyclodextrin inclusion process was 5 hours. The filtrate after the
volatile oil extraction was collected for later use. The drug
residues after the volatile oil extraction was mixed with weighed
Poria cocos, Astragalus, wild Chrysanthemum flower, Ganoderma
lucidum, honeysuckle, Sophora flavescens, and Radix glycyrrhizae,
according to the weight percentage, and added into water which
amount was 10-15 times (optimally, 12 times) than the drug residues
and the medicinal materials thereof, and decocted for 2-5 times
(optimally 3 times), and each time for 1-2 hours (optimally 1.5
hours). Filtered the decocted drug solution and mixed the drug
solution with the filtrate after the volatile oil extraction to
obtain a traditional Chinese medicine mixed solution. The
traditional Chinese medicine mixed solution was concentrated by
water bath and concentrated to the relative density of 1.06-1.08
paste, and then added ethanol containing alcohol amounted to 60%,
stand still for 12 hours or more (optimally 24 hours) to obtain a
traditional Chinese medicine mixed alcohol solution. The
traditional Chinese medicine mixed alcohol solution was
concentrated under reduced pressure, dried, and added with the
volatile oil cyclodextrin inclusion complex, so as to obtain the
traditional Chinese medicine composition.
[0072] Pharmacodynamic Test:
[0073] To examine the effect of the traditional Chinese medicine
composition of the present disclosure in treating tumor, the
traditional Chinese medicine composition respectively prepared by
the first embodiment and the second embodiment (respectively
referred to as traditional Chinese medicine composition No. 1 and
traditional Chinese medicine composition No. 2) were used for the
following pharmacodynamic test.
[0074] The clinical recommended dose for adult of the traditional
Chinese medicine composition for treating tumor of the present
disclosure is 7.6 g crude drug/60 kg/d, the equivalent dose of nude
mouse is 1.4 g/kg/d. 2.8, 1.4, 0.7 g/kg/d three dose groups
(respectively corresponding to twice, equivalent and 1/2 fold of
the clinical dose for adult) were administered in the test.
[0075] Inhibition of the traditional Chinese medicine composition
for treating tumor of the present disclosure on the human lung
adenocarcinoma cell line (A549) in nude mice model.
[0076] Compared with the model group, the tumor volume of each
dosage group obtained from embodiments 1 and 2 administration was
decreased, and the tumor volumes of the groups of day 8
administration were significantly decreased (P<0.01, P<0.05).
Compared with the model control group, the T/C % of the traditional
Chinese medicine composition No. 1 with high dose group and the
traditional Chinese medicine composition No. 2 with medium dose
group were 28-70%. Each tumor weight of the administration groups
had difference from the tumor weight of the model control group
(P<0.01). These result shows that the tumor volume of the
traditional Chinese medicine composition No. 2 with medium dose
group at the 5 detection time from day 4 to 20 of administration
were different (P<0.01) from the tumor volume of the model
control group, the T/C % of the traditional Chinese medicine
composition No. 2 with medium dose group was lower than 40% after
the day 8 administration, and the traditional Chinese medicine
composition No. 2 with medium dose group has the smallest tumor
lump.
1 TEST MATERIAL
[0077] 1.1 Test drug: traditional Chinese medicine composition No.
1 and traditional Chinese medicine composition No. 2.
Administration and dosage: oral, the clinical recommended dose is
7.6 g of crude drug daily.
[0078] 1.2 Positive control drug: compound cyclophosphamide tablet,
manufacturer: Tonghua Maoxiang Pharmaceutical Co., Ltd.
Indications: malignant lymphoma, multiple myeloma, lymphocytic
leukemia, neuroblastoma tumor, ovarian cancer, breast cancer and
lung cancer, and various sarcomas. Lot number: 160702, manufacture
date: 2016 July 25, expiry date: 2018 June. Ingredients: compound,
component: cyclophosphamide (50 mg) and ginsenoside extract of
Ginseng stems and leaves (50 mg). Properties: enteric coated
tablets, appearing yellowish or taupe after removal of the coating.
Specifications: cyclophosphamide 50 mg, ginsenoside extract of
Ginseng stems and leaves 50 mg, 12 tablets/plate, 2 plates/box.
Dosage of use: 1 tablet at a time, 3-4 times a day for adults.
Storage conditions: shading, sealed and stored below 30.degree.
C.
[0079] 1.3 Test Animals
TABLE-US-00001 Certificate Certificate Strain Level weight numbers
gender number number Provided by nude SPF 19 .+-. 1 g 88 male/
SCXK(Beijing) 11400700187753 Beijing Vital River mice, grade female
2012-0001 Laboratory Animal BALB/c evenly Technology Co., Nude
Ltd
[0080] 1.4 Tumor Cell Line
TABLE-US-00002 Tumor cell line Use Resource A549 human lung
establishing lung cancer Cell Culture Center of adenocarcinoma
xenograft model on nude Chinese Academy of cancer cell mice Medical
Sciences Basics Medical Science Institute
2 TEST METHOD
[0081] 2.1 Dosage Design
[0082] 2.1.1 The traditional Chinese medicine composition for
treating tumor: the clinical recommended dose for adult is 7.6 g
crude drug/60 kg/d. Converted according to the test body surface
area in terms of human and animal, the dosage of mice is 11 times
the dosage of human, and the administration dose of mice is
(7.6/60).times.11=1.4 g crude drug/kg/d. The concentration of the
test solution is 2 g crude drug/ml, converting into the dosage of
mice based on volume is (1.4/2)*1=0.7 ml/kg/d, and thus the high,
medium and low doses of the three traditional Chinese medicine
compositions are 1.4 ml/kg/d, 0.7 ml/kg/d, and 0.35 ml/kg/d
(respectively corresponding to twice, equivalent and 1/2 fold of
the clinical dose for adult).
[0083] 2.1.2 Compound cyclophosphamide tablet: the clinical
recommended dose for adult is 175 mg/60 kg/d. Converted according
to the test body surface area in terms of human and animal, the
dosage of mice is 11 times the dosage of human, and the
administration dose of mice is (175/60).times.11=32 mg/kg/d.
[0084] 2.2 Culture of the human lung adenocarcinoma cell line
(A549). Cells were cultured in complete medium (DMEM medium+10%
fetal calf serum, pH 7.2), placed in 37.degree. C. 5% CO.sub.2
incubator, replaced medium daily. When cells were grown to 80-90%
fusion rate, digested with 0.25% trypsin and were passaged after
centrifugation. Until cells were grown to a certain amount, diluted
into tumor cells suspension in PBS to inject into the test animal
model.
[0085] 2.3 In vitro activity assay and preparation of tumor cell
suspension. The selected well-growing tumor cells were digested
with 0.25% trypsin and were suspended after centrifugation under
sterile conditions. Cell viability was measured and counted using
trypan blue staining by a fully automated cell counter. The tumor
cell suspension was diluted with PBS to a concentration of
2.times.10.sup.7 cells/ml.
[0086] 2.4 Preparation of human lung cancer xenograft model by
injection of A549 tumor cells. 18.+-.2 g nude mice were selected,
male and female evenly, and adaptive feeding in experimental animal
centers for 7 days. Under sterile conditions, nude mice were
disinfected with 75% ethanol, and 0.2 ml of human lung
adenocarcinoma A549 cell suspension was subcutaneous injected into
the right armpit of nude mice. After injection, the nude mice were
returned to the cage, and the spirit diet and defecation of the
mice were observed regularly. About 1 week after injection, the
built xenograft model was confirmed by observed the grain size hard
lumps grown under the skin of injection position.
[0087] 2.5 Grouping and administration. 2 weeks after tumor cells
injection, the nude mice with evenly lump and weight were randomly
divided into 8 groups: model control group, cyclophosphamide
positive control group, traditional Chinese medicine composition
No. 1 with high, medium, low three dose groups, and traditional
Chinese medicine composition No. 2 with high, medium, low three
dose groups. 7 mice in each group were administered on the day of
grouping, and the dose was 0.2 ml/10 g once a day, orally, for 3
weeks.
[0088] 2.6 Observation index. The body weight and tumor volume of
nude mice were measured on the day of administration. The mice were
measured every 3 days. The nude mice were weighed and sacrificed
three weeks later, and the tumor tissues were weighed. The average
tumor weight, tumor growth inhibition rate, tumor volume relative
volume, and relative tumor growth rate of each group were
calculated.
[0089] Calculation Method:
[0090] Tumor volume (TV) is calculated as: V=1/2.times.a.times.b2,
and a and b represent the length, width and height,
respectively.
[0091] Relative tumor volume (RTV) is calculated as follows:
RTV=Vt/V0, V0 is the tumor volume obtained at grouping (i.e. d0),
and Vt is the tumor volume at each measurement.
[0092] Relative tumor growth rate T/C (%) (Evaluation index of
anti-tumor activity) is calculated as: T/C %=TRTV/CRTV.times.100%.
(TRTV: treatment group RTV; CRTV: negative control group RTV).
[0093] 2.7 Statistical processing of experimental data. After the
Excel table was completed, the SPSS13.0 statistical software
package was used for analysis, and the measurement data was
referred to as .X.+-.s, the t test was used for comparison between
the two groups. One-way analysis of variance was used for
comparison between groups, and P<0.05 was considered
statistically significant.
3 TEST RESULTS
[0094] 3.1 A549 tumor cell count (cell concentration at injection).
After the cells were centrifuged and suspended in PBS, 20 .mu.l
trypan blue dye was added after diluted 10 .mu.l cell suspension
twice, added the suspension into cell counting plate percussion
uniformly, and the cell counting plate was inserted into the
automatic detecting cytometer. Total cell number:
2.14.times.10.sup.7/ml; viable cell number: 1.5.times.10.sup.7/ml;
the number of dead cells: 6.42-10.sup.6/ml, cell viability:
95.04%.
[0095] 3.2 Effect of the tumor volume growth in nude mice model
injected with human lung adenocarcinoma cell line (A549)
TABLE-US-00003 TABLE 1 Effect of the traditional Chinese medicine
composition on the tumor volume in nude mice injected with human
lung adenocarcinoma cell line (A549). (X .+-. s, n = 7) before
administration administration Group dose administration on Day 4 on
Day 8 Model control -- 11.59 .+-. 3.49 44.04 .+-. 16.99 123.95 .+-.
53.48 Compound 32 12.42 .+-. 3.83 32.00 .+-. 11.08 106.33 .+-.
42.09 cyclophosphamide mg kg-1 tablet traditional Chinese 1.4 10.05
.+-. 4.65 24.32 .+-. 7.94* 55.30 .+-. 19.01** medicine ml kg-1
composition No. 1 with high dose traditional Chinese 0.7 7.72 .+-.
3.80 24.53 .+-. 13.02* 46.86 .+-. 38.68** medicine ml kg-1
composition No. 1 with medium dose traditional Chinese 0.35 8.10
.+-. 5.04 36.16 .+-. 17.79 78.73 .+-. 43.13* medicine ml kg-1
composition No. 1 with low dose traditional Chinese 1.4 10.92 .+-.
7.32 35.30 .+-. 12.88 81.31 .+-. 38.60* medicine ml kg-1
composition No. 2 with high dose traditional Chinese 0.7 10.59 .+-.
4.43 19.91 .+-. 10.41** 41.27 .+-. 22.86** medicine ml kg-1
composition No. 2 with medium dose traditional Chinese 0.35 10.34
.+-. 6.12 37.52 .+-. 8.87 59.09 .+-. 27.36** medicine ml kg-1
composition No. 2 with low dose administration administration on
administration on Group dose on Day 12 Day 16 Day 20 Model control
-- 206.57 .+-. 83.50 416.03 .+-. 98.29 792.08 .+-. 269.58 Compound
32 187.94 .+-. 58.35 326.93 .+-. 128.45 455.04 .+-. 157.54**
cyclophosphamide mg kg-1 tablet traditional Chinese 1.4 114.42 .+-.
73.39** 208.35 .+-. 166.96** 339.98 .+-. 226.46** medicine ml kg-1
composition No. 1 with high dose traditional Chinese 0.7 71.99 .+-.
51.03** 159.24 .+-. 150.40** 280.06 .+-. 210.39** medicine ml kg-1
composition No. 1 with medium dose traditional Chinese 0.35 87.82
.+-. 31.24** 202.63 .+-. 111.31** 382.26 .+-. 216.29** medicine ml
kg-1 composition No. 1 with low dose traditional Chinese 1.4 118.16
.+-. 70.50** 255.01 .+-. 161.66* 398.81 .+-. 280.86** medicine ml
kg-1 composition No. 2 with high dose traditional Chinese 0.7 64.68
.+-. 43.43** 107.22 .+-. 92.69** 203.15 .+-. 159.32** medicine ml
kg-1 composition No. 2 with medium dose traditional Chinese 0.35
87.82 .+-. 31.24** 173.10 .+-. 62.49** 317.92 .+-. 118.75**
medicine ml kg-1 composition No. 2 with low dose Compared with the
model control group, *P < 0.05 **P < 0.01
[0096] The results showed that, from the second day of
administration, the tumor volume of the two traditional Chinese
medicine composition groups were all decreased compared with the
tumor volume of the model control group. The tumor volume of the
two traditional Chinese medicine composition groups were
significantly decreased compared with the tumor volume of the model
control group after the 8-20 day of administration (P<0.01,
P<0.05), where the tumor volume of the traditional Chinese
medicine composition No. 2 with medium dose group at the 5
detection time from day 4 to 20 of administration were different
(P<0.01) compared with the tumor volume of the model control
group and also the most significant from the data.
[0097] 3.3 Effect of the relative tumor volume (RTV) and the
relative tumor growth rate in nude mice model injected with human
lung adenocarcinoma cell line (A549).
TABLE-US-00004 TABLE 2 Effect of the traditional Chinese medicine
composition on the relative tumor volume (RTV) and relative tumor
growth rate (T/C %) in nude mice injected with human lung
adenocarcinoma cell line (A549). (X .+-. s, n = 7) administration
on Day 4 administration on Day 8 Group dose RTV T/C % RTV T/C %
Model control -- 3.85 .+-. 1.62 -- 10.98 .+-. 5.37 -- Compound 32
2.81 .+-. 1.60 72.99 9.00 .+-. 4.22 81.97 cyclophosphamide mg kg -1
tablet traditional 1.4 2.84 .+-. 1.55 73.77 6.08 .+-. 2.14 55.37
Chinese medicine ml kg-1 composition No. 1 with high dose
traditional 0.7 4.24 .+-. 4.64 110.13 9.98 .+-. 16.51 90.89 Chinese
medicine ml kg-1 composition No. 1 with medium dose traditional
0.35 5.14 .+-. 2.40 133.51 11.33 .+-. 5.91 103.19 Chinese medicine
ml kg-1 composition No. 1 with low dose traditional 1.4 4.17 .+-.
2.12 108.31 9.16 .+-. 4.67 83.42 Chinese medicine ml kg-1
composition No. 2 with high dose traditional 0.7 2.21 .+-. 1.41
57.40 4.20 .+-. 2.02 38.25 Chinese medicine ml kg-1 composition No.
2 with medium dose traditional 0.35 5.10 .+-. 4.62 132.47 8.54 .+-.
6.37 77.78 Chinese medicine ml kg-1 composition No. 2 with low dose
administration on Day 12 administration on Day 16 Group dose RTV
T/C % RTV T/C % Model control -- 18.72 .+-. 8.73 -- 37.53 .+-.
11.79 -- Compound 32 16.35 .+-. 7.56 87.34 28.51 .+-. 16.56 75.97
cyclophosphamide mg kg-1 tablet traditinal 1.4 11.55 .+-. 6.54
63.46 18.68 .+-. 8.79 49.77 Chinese medicine ml kg-1 composition
No. 1 with high dose traditional 0.7 14.29 .+-. 21.62 78.52 21.14
.+-. 24.65 56.33 Chinese medicine mg kg-1 composition No. 1 with
medium dose traditional 0.35 16.11 .+-. 9.25 86.06 28.25 .+-. 14.24
61.95 Chinese medicine ml kg-1 composition No. 1. with low dose
traditional 1.4 12.73 .+-. 6.63 69.95 29.61 .+-. 19.66 78.90
Chinese medicine ml kg-1 composition No. 2 with high dose
traditional 0.7 6.56 .+-. 4.00 35.04 10.78 .+-. 9.00 28.72 Chinese
medicine ml kg-1 composition No. 2 with medium dose traditional
0.35 12.43 .+-. 9.03 65.92 23.05 .+-. 14.07 61.42 Chinese medicine
ml kg-1 composition No. 2 with low dose administration on Day 20
Group dose RTV T/C % Model control -- 70.25 .+-. 26.43 -- Compound
32 40.66 .+-. 22.80 57.88 cyclophosphamide mg kg-1 tablet
traditional Chinese 1.4 31.73 .+-. 12.50 45.01 medicine mg kg-1
composition No. 1 with high dose traditional Chinese 0.7 56.15 .+-.
84.70 79.93 medicine ml kg-1 composition No. 1 with medium dose
traditional Chinese 0.35 52.74 .+-. 28.24 75.07 medicine ml kg-1
composition No. 1 with low dose traditional Chinese 1.4 45.27 .+-.
29.78 64.44 medicine ml kg-1 composition No. 2 with high dose
traditional Chinese 0.7 20.60 .+-. 15.79* 29.32 medicine ml kg-1
composition No. 2 with medium dose traditional Chinese 0.35 38.76
.+-. 17.94 55.17 medicine ml kg-1 composition No. 2 with low dose
Compared with the model control group, *P < 0.05, **P <
0.01
[0098] The results showed that the RTV of the traditional Chinese
medicine composition No. 2 with medium dose group was different
compared with the RTV of the model control group (P<0.05), and
the rest of the administration groups and model groups has no
differences. Compared with the model control group, the T/C % of
the traditional Chinese medicine composition No. 1 with high dose
group and the traditional Chinese medicine composition No. 2 with
medium dose group were 28-70%, and the T/C % of the rest of the
administration groups were between 50-90%.
[0099] 3.4 Effect of the tumor weight in nude mice model injected
with human lung adenocarcinoma cell line (A549).
TABLE-US-00005 TABLE 3 Effect of the traditional Chinese medicine
composition on the tumor weight in nude mice injected with human
lung adenocarcinoma cell line (A549). (X .+-. s, n = 7) Group dose
tumor weight Model control -- 0.610 .+-. 0.058 Compound 32 mg kg-1
0.381 .+-. 0.133** cyclophosphamide tablet traditional Chinese 1.4
ml kg-1 0.210 .+-. 0.114** medicine composition No. 1 with high
dose traditional Chinese 0.7 ml kg-1 0.187 .+-. 0.138** medicine
composition No. 1 with medium dose traditional Chinese 0.35 ml kg-1
0.306 .+-. 0.191** medicine composition No. 1 with low dose
traditional Chinese 1.4 ml kg-1 0.300 .+-. 0.250** medicine
composition No. 2 with high dose traditional Chinese 0.7 ml kg-1
0.125 .+-. 0.108** medicine composition No. 2 with medium dose
traditional Chinese 0.35 ml kg-1 0.255 .+-. 0.085** medicine
composition No. 2 with low dose Compared with the model control
group, *P < 0.05, **P < 0.01
[0100] Each tumor weight of the administration groups had
difference from the tumor weight of the model control group
(P<0.01), and the traditional Chinese medicine composition No. 2
with medium dose group had the smallest tumor lump.
4. SUMMARY
[0101] The traditional Chinese medicine composition of the present
disclosure has inhibition on the tumor growth of the nude mice
injected with human lung adenocarcinoma cell line (A549). Both two
the traditional Chinese medicine composition can decrease the tumor
volume, RTV, T/C %, and tumor weight of nude mice. The efficacy
from high to low was the traditional Chinese medicine composition
No. 2> the traditional Chinese medicine composition No. 1>
compound cyclophosphamide tablet.
[0102] The foregoing is only preferred embodiments of the present
disclosure, they are used to illustrate the application of the
traditional Chinese medicine composition for treating tumor, and
not to limit the scope of the present disclosure. In the scope of
the present disclosure described in the claims and their
equivalents.
* * * * *