CN102078409B - Traditional Chinese medicine preparation for treating liver cancer - Google Patents
Traditional Chinese medicine preparation for treating liver cancer Download PDFInfo
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Abstract
The invention relates to a medical configuration item, in particular to a traditional Chinese medicine preparation for treating liver cancer. The preparation is composed of an effective ingredient and medically acceptable excipients, wherein the effective ingredient is prepared by the following bulk drugs on a mass basis: 5-30% of underleaf pearl, 5-20% of sophora flavescens, 5-30% of rabdosia serra, 4-10% of panax notoginseng, 5-25% of salvia, 4-15% of peach kernel, 4-10% of bupleurum, 5-25% of ligustrum lucidum, 5-25% of yerbadetajo herb, 2-25% of radix pseudostell, and 2-10% of licorice. By combining above 11 drugs, the preparation has heat-clearing and detoxifying, blood-activiating and stasis-dissolving, liver-soothing and depression-resolving, spleen-invigorating and kidney-tonifying efficacy, and furthermore the preparation can inhibit the growth of tumors and achieve the purpose of treating liver cancers.
Description
Technical field
The present invention relates to medical configuration article, being specifically related to the plant is the Chinese patent medicine of raw material.
Background technology
Primary hepatocarcinoma (PLC, be called for short hepatocarcinoma) is one of modal malignant tumor clinically, and global sickness rate increases year by year, surpass 62.6 ten thousand/year, occupy the 5th of malignant tumor; Dead near 600,000/year, occupy the 3rd of tumor associated death.China is the state occurred frequently of hepatocarcinoma, and 30.6 ten thousand people morbidity is arranged every year, and new cases account for the whole world 55%, and have every year 300000 people to die from hepatocarcinoma approximately, are the major diseases of serious threat China people health and lives.
Onset of liver cancer is that multifactor, multistep is rapid, the result of polygenic mutation.Pathogenic factor is main and hepatitis B virus (HBV) infects or hepatitis C virus (HCV) infects the posthepatitic cirrhosis that causes, and long-term excessive drinking causes alcoholic cirrhosis closely related.
Western medical treatment hepatocarcinoma mainly adopts interventional therapy and chemotherapy except that excision at present, even but radical excision still has 60%～70% relapse rate in 5 years; In addition owing to volume, the position of focus, the outer transfer of liver and the hepatitis of hepatocarcinoma, the reasons such as liver function restriction of liver cirrhosis, make can surgical resection hepatocarcinoma patient account for 30%, but and patient's operability of suffering from liver cirrhosis is merely 15%-30%.Because at present the chemotherapeutics selectivity is not high, in killing tumor cell, the normal cell of body also there is lethal effect; Bring out the danger of secondary tumors and multidrug resistance in addition, these factors seriously limit the clinical use of chemotherapeutics.
Chinese medicine hepatocarcinoma can be through liver cancer apoptosis reducing, suppress its proliferation-inducing cell differentiation; Enhancing human body immunity function etc. reaches treatment disease purpose; Effect characteristics with many target spots; And toxic and side effects is little, and clinical practice can suppress liver cancer cell growth, the prolongation patient is with the tumor life span, the quality of making the life better.In recent years, Chinese medicine rises in the Comprehensive Treatment of hepatocarcinoma and plays an increasingly important role, and the Chinese medicine of hepatocarcinoma is still the research focus of industry.At present, the Chinese traditional treatment of hepatocarcinoma mainly contains medicine typing treatment, specific prescription and medication treatment, Chinese patent drugs for treatment, Chinese medicine injection treatment, external treatment, Chinese medicine interventional therapy etc.Wherein, In the long-term clinical practice of Chinese medicine hepatocarcinoma, the tame medicine of having explored some effective empirical formulas and multiple dosage form of many doctors demonstrates good and clinical curative effect; For example; Notification number is that the patent of invention of CN 1189203C discloses " a kind of Chinese medicine and production method of treating liver cirrhosis, hepatitis, hepatocarcinoma ", and wherein said Chinese medicine has the effect of strengthening the body resistance, heat clearing and damp drying, detoxicating and resolving stagnation of pathogens, and control liver cirrhosis, hepatitis, hepatocarcinoma are had good efficacy; Notification number is that the patent of invention of CN 100340280C discloses " a kind of medicine of treating hepatocarcinoma "; This medicine be a kind of by 11 kinds of raw materials such as Herba Saussureae Involueratae, Rhizoma Curcumae, Qin Wan or/and pharmaceutic adjuvant process; It is pointed strong, advantage evident in efficacy, that toxicity is little.
As everyone knows; Oncotherapy is a global problem; Its treatment approach and target spot still among exploring, are therefore given full play to the Chinese medicine speciality, develop different treatment approach and target spot Chinese medicine preparation to hepatocarcinoma; For improving hepatopath's quality of life and cachexia, it is still significant life cycle to prolong the patient.
Summary of the invention
Technical problem to be solved by this invention provides a kind of Chinese medicine preparation of treating hepatocarcinoma, but the said preparation heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dispersing the stagnated live-QI to relieve the stagnation of QI, strengthening spleen, tonifying kidney suppresses tumor growth.
In order to address the above problem, the technical scheme that the present invention adopted is:
A kind of Chinese medicine preparation of treating hepatocarcinoma, said preparation is made up of active ingredient and medical science acceptable auxiliary, it is characterized in that,
Described active ingredient is processed by following raw materials by weight percent medicine:
Cacumen Securinegae Suffruticosae 5-30%, Radix Sophorae Flavescentis 5-20%, Herba Rabdosiae Lophanthoidis 5-30%, Radix Notoginseng 4-10%, Radix Salviae Miltiorrhizae 5-25%, Semen Persicae 4-15%, Radix Bupleuri 4-10%, Fructus Ligustri Lucidi 5-25%, Herba Ecliptae 5-25%, Radix Pseudostellariae 2-25%, Radix Glycyrrhizae 2-10%;
The method for preparing of described active ingredient is made up of following steps:
(1) with the crude drug cutting, pulverize, add 8～12 times 60% ethanol, homogenate, centrifugal, obtain centrifugal liquid and centrifugal slag;
(2) centrifugal liquid that step (1) is made is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element; First then reverse osmosis concentration reclaims the extractum that ethanol and vacuum concentration become to be equivalent to contain in every liter of extractum 1.5～2kg crude drug again to being equivalent to contain 0.8～1.2kg crude drug in every liter of concentrated solution;
10～20 times water mix homogeneously of the centrifugal slag that (3) step (1) is made and the total amount of said crude drug; Stirring furnishing slurry; Homogenate; Through ceramic membrane filter element and the ultrafiltration of 10Kda filter element, reverse osmosis concentration must be equivalent to contain in every liter of concentrated solution the concentrated solution of 2～4kg crude drug successively for centrifugal removing slag, centrifugal liquid;
(4) step (2) extractum that makes and the concentrated solution that step (3) is made are merged, mix, through the filtering of ceramic membrane filter element, spray drying promptly gets.
The Chinese medicine preparation of treatment hepatocarcinoma according to the invention, the optimum weight proportioning of wherein said crude drug is: Cacumen Securinegae Suffruticosae 12.5%, Herba Rabdosiae Lophanthoidis 12.5%; Radix Sophorae Flavescentis 10.4%, Radix Notoginseng 4.2%, Radix Salviae Miltiorrhizae 12.5%; Semen Persicae 4.2%, Radix Bupleuri 4.2%, Fructus Ligustri Lucidi 12.5%; Herba Ecliptae 12.5%, Radix Pseudostellariae 12.5%, Radix Glycyrrhizae 2.0%.
Chinese medicine preparation can be the oral formulations of various routines, like granule, tablet or capsule etc.
The Chinese medicine preparation of treatment hepatocarcinoma of the present invention, wherein, Cacumen Securinegae Suffruticosae, Radix Sophorae Flavescentis heat-clearing and toxic substances removing are monarch drug; The Herba Rabdosiae Lophanthoidis heat-clearing and toxic substances removing, Radix Notoginseng, Radix Salviae Miltiorrhizae, Semen Persicae blood circulation promoting and blood stasis dispelling are ministerial drug; Fructus Ligustri Lucidi, Herba Ecliptae nourishing kidney yin, Radix Pseudostellariae air making-up and spleen enlivening, Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI are adjuvant drug; The Radix Glycyrrhizae mediation property of medicine is messenger drug.Above-mentioned ten share simply, gather heat-clearing and toxic substances removing altogether, blood circulation promoting and blood stasis dispelling, and the effect of dispersing the stagnated live-QI to relieve the stagnation of QI and strengthening spleen, tonifying kidney, and then suppress tumor growth, reach the purpose of treatment hepatocarcinoma.
The specific embodiment
Example 1
1, prescription:
Cacumen Securinegae Suffruticosae 2160g, Radix Sophorae Flavescentis 1440g, Herba Rabdosiae Lophanthoidis 1080g, Radix Notoginseng 288g, Radix Salviae Miltiorrhizae 360g, Semen Persicae 360g, Radix Bupleuri 360g, Fructus Ligustri Lucidi 360g, Herba Ecliptae 360g, Radix Pseudostellariae 288g, Radix Glycyrrhizae 144g.
2, method for preparing:
(1) by the cutting of prescription weighting raw materials, pulverize, add 12 times 60% ethanol, homogenate, centrifugal, obtain centrifugal liquid and centrifugal slag;
(2) centrifugal liquid that step (1) is made is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element; First then reverse osmosis concentration to cocnentration factor is 1: 1 (being equivalent to contain in every liter of concentrated solution the 1kg crude drug), and reclaiming ethanol and vacuum concentration again, to become cocnentration factor be the extractum of 2: 1 (being equivalent to contain the 2kg crude drug in every liter of extractum);
(3) the water mix homogeneously that the centrifugal slag that step (1) is made and the total amount of said crude drug are 10 times; Stirring furnishing slurry; Homogenate; The centrifugal b that removes slag, centrifugal liquid is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element, and reverse osmosis concentration gets the concentrated solution that cocnentration factor is 3: 1 (being equivalent to contain the 3kg crude drug in every liter of concentrated solution);
(4) step (2) extractum that makes and the concentrated solution that step (3) is made are merged, mix, through the filtering of ceramic membrane filter element, spray drying makes active ingredient;
(5) active ingredient being starched with 15% maltodextrin is binding agent, spray granulation, and the magnesium stearate of adding granule total amount 0.5%, mix homogeneously, tabletting promptly gets tablet, the 0.5g/ sheet.
3, instructions of taking and dosage:
Warm water takes, every day 3 times, each 4.
Example 2
1, prescription:
Cacumen Securinegae Suffruticosae 900g, Herba Rabdosiae Lophanthoidis 900g, Radix Sophorae Flavescentis 748.8g, Radix Notoginseng 302.4g, Radix Salviae Miltiorrhizae 900g, Semen Persicae 302.4g, Radix Bupleuri 302.4g, Fructus Ligustri Lucidi 900g, Herba Ecliptae 900g, Radix Pseudostellariae 900g, Radix Glycyrrhizae 144g.
2, method for preparing:
(1) by the cutting of prescription weighting raw materials, pulverize, add 8 times 60% ethanol, homogenate, centrifugal, obtain centrifugal liquid and centrifugal slag;
(2) centrifugal liquid that step (1) is made is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element; First then reverse osmosis concentration to cocnentration factor is 1: 1 (being equivalent to contain in every liter of concentrated solution the 1kg crude drug), and reclaiming ethanol and vacuum concentration again, to become cocnentration factor be the extractum of 1.6: 1 (being equivalent to contain the 1.6kg crude drug in every liter of extractum);
(3) the water mix homogeneously that the centrifugal slag that step (1) is made and the total amount of said crude drug are 15 times; Stirring furnishing slurry; Homogenate; The centrifugal b that removes slag, centrifugal liquid is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element, and reverse osmosis concentration gets the concentrated solution that cocnentration factor is 3: 1 (being equivalent to contain the 3kg crude drug in every liter of concentrated solution);
(4) step (2) extractum that makes and the concentrated solution that step (3) is made are merged, mix, through the filtering of ceramic membrane filter element, spray drying makes active ingredient;
(5) active ingredient being starched with 15% maltodextrin is binding agent, spray granulation, and quantitatively packing gets granular preparation, the 4.0g/ bag.
3, instructions of taking and dosage:
Warm water takes, every day 1 time, each 2 bags.
Example 3
1, prescription:
Cacumen Securinegae Suffruticosae 360g, Radix Sophorae Flavescentis 360g, Herba Rabdosiae Lophanthoidis 360g, Radix Notoginseng 576g, Radix Salviae Miltiorrhizae 1440g, Semen Persicae 720g, Radix Bupleuri 720g, Fructus Ligustri Lucidi 720g, Herba Ecliptae 720g, Radix Pseudostellariae 1080g, Radix Glycyrrhizae 144g.
(1) by the cutting of prescription weighting raw materials, pulverize, add 10 times 60% ethanol, homogenate, centrifugal, obtain centrifugal liquid and centrifugal slag;
(2) centrifugal liquid that step (1) is made is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element; First then reverse osmosis concentration to cocnentration factor is 1: 1 (being equivalent to contain in every liter of concentrated solution the 1kg crude drug), and reclaiming ethanol and vacuum concentration again, to become cocnentration factor be the extractum of 1.6: 1 (being equivalent to contain the 1.6kg crude drug in every liter of extractum);
(3) the water mix homogeneously that the centrifugal slag that step (1) is made and the total amount of said crude drug are 15 times; Stirring furnishing slurry; Homogenate; The centrifugal b that removes slag, centrifugal liquid is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element, and reverse osmosis concentration gets the concentrated solution that cocnentration factor is 3: 1 (being equivalent to contain the 3kg crude drug in every liter of concentrated solution);
(4) step (2) extractum that makes and the concentrated solution that step (3) is made are merged, mix, through the filtering of ceramic membrane filter element, spray drying makes active ingredient;
(5) active ingredient being starched with 15% maltodextrin is binding agent, spray granulation, and the magnesium stearate of adding granule total amount 0.5%, mix homogeneously, filled capsules promptly gets capsule, 0.35/.
3, instructions of taking and dosage:
Warm water takes, every day 3 times, each 6.
Example 4 (anti-liver cancer drug is imitated and learned test)
(1) experiment material and method
1. experiment material
1.1 supply the reagent thing
The confession reagent thing of treatment group 1: get embodiment 1 resulting active ingredient, add, be made into the medicinal liquid that active ingredient concentration is 0.14Kg/L with dissolved in distilled water.
The confession reagent thing of treatment group 2: get embodiment 2 resulting active ingredients, add, be made into the medicinal liquid that active ingredient concentration is 0.14Kg/L with dissolved in distilled water.
The confession reagent thing of treatment group 3: get embodiment 3 resulting active ingredients, add, be made into the medicinal liquid that active ingredient concentration is 0.14Kg/L with dissolved in distilled water.
1.2 laboratory animal:
SPF level Kunming mouse, male, age in 6-8 week, body weight 22 ± 2g, available from Guangdong Medical Lab Animal Center, credit number: SCXK (Guangdong) 2008-0002.The animal feeding environment: room temperature is 23 ± 2 ℃, and relative humidity is 40-75%, adopts standard feed and water to raise.
1.3 tumor cell line:
Mice H22 hepatoma cell strain behind mouse peritoneal inoculation 7～8d, extracts ascites, as the tumor kind that goes down to posterity available from Zhongshan University's medical college animal center cell bank under aseptic condition.
1.4 serum il-2, TNF-a radio immunoassay (hereinafter to be referred as putting the method for exempting from) detection kit:
Provide by Beijing pul great achievement bio tech ltd.
1.5 experimental apparatus:
The SN-695B type is put and is exempted from measuring instrument (Shanghai day ring instrument one factory), TLL-C tabletop refrigerated centrifuge (Fourth Ring, Beijing scientific instrument factory), GB303 electronic analytical balance.
2. experimental technique
2.1. modeling method
Tumor strain inoculation method is according to the method for the 3rd national oncology pharmacology in 1989 and chemotherapy academic conference regulation and optimize and improve.Get the milky cancer ascites of H22 ascites hepatocarcinoma tumor-bearing mice, with normal saline dilution in 1: 3; And the counting cancerous cell, contain 1 * 10
7Individual cell/ml, every right side of mice axillary fossa subcutaneous vaccination 0.2ml, preparation H22 hepatocarcinoma tumor-bearing mice.
2.2 press down the tumor experiment
50 Male Kunming strain mice prepare the hepatocarcinoma bearing mouse model as stated above, behind the modeling 24h mice are divided into 5 groups at random, 10 every group; Be respectively: model group, treatment group 1～3 and cyclophosphamide group, wherein, the dosage of treatment group 1～3 is all by 4.8g/kg body weight (being equivalent to clinical medicine dose after the conversion) gastric infusion, and the dosage of cyclophosphamide group is by 20mg/kg body weight (being equivalent to clinical medicine dose after the conversion) intraperitoneal injection; Model group is given the equal-volume normal saline and is irritated stomach, every day 1 time, continuous 8 days; Behind the last administration 24h, mice is weighed, after eye socket is got blood; After hemopexis is treated in placement, centrifugalize serum ,-20 ℃ are frozen to be checked.Disconnected neck is put to death mice, gets the subcutaneous tumors piece and weighs, and wins spleen and thymus is weighed.
3. serum il-2, TNF-a horizontal detection:
The method of exempting from is put in employing, presses the operation of test kit description.
4. therapeutic evaluation
4.1 solid tumor therapeutic evaluation
The curative effect of solid tumor is represented with tumour inhibiting rate:
Tumour inhibiting rate (%)=[(the average tumor of the average tumor weight-corresponding administration group of model group is heavy)/average tumor of model group is heavy] * 100%
4.2 thymus index and index and spleen index
Thymus index=thymic weight (mg)/body weight (g); Index and spleen index=spleen weight (mg)/body weight (g).
5. statistical procedures:
Measurement data is represented with mean ± standard deviation
; Adopt the SPSS10.0 software kit to carry out statistical analysis; One way ANOVA is adopted in the analysis of many batch totals amount; Multiple comparisons adopts LSD, with P＜0.05 expression difference the significance meaning is arranged.
(2) result
1. general situation and body weight change before and after the medication
Mice activity before the modeling, diet, hair color are all no abnormal.Test the 5th day mice oxter and can touch tumor, cyclophosphamide group mice hair color is darker, irritability, the no significant change of all the other each groups.It is all very fast that medication is in earlier stage respectively organized the mice weight increase, and later stage cyclophosphamide group weight increase slows down.Respectively organizing mice body weight difference before the experiment does not have remarkable sexology meaning (P＞0.05), and cyclophosphamide group and model group compared when experiment finished, and the body weight difference of mice has significance meaning (P＜0.05), sees table 1.
Body weight change
before and after table 1. medication
Annotate: compare * P＜0.05 with model group
2. Chinese medicine compound is to the influence of H22 hepatocarcinoma transplanted tumor mouse tumor weight, index and spleen index, thymus index
With model group relatively, treatment group 1, treatment group 2 and treatment organize that 3 tumors are heavy obviously to be reduced, difference all has significance meaning (P＜0.01), with the cyclophosphamide group relatively, difference there are no significant meaning (P＞0.05).
3 thymus indexs are organized in treatment group 1, treatment group 2 and treatment and model group compares, and difference does not have significance meaning (P＞0.05), but compare with the cyclophosphamide group, and difference all has significance meaning (P＜0.01).
3 spleen indexs are organized in treatment group 1, treatment group 2 and treatment and model group compares, and difference has significance meaning (P＜0.01), compare with the cyclophosphamide group, and difference all has significance meaning (P＜0.01).See table 2.
Table 2. Chinese medicine compound is to the influence
of H22 hepatocarcinoma transplanted tumor mouse tumor weight, index and spleen index, thymus index
Annotate: compare * P＜0.05, * * P＜0.05 with model group; Compare with the cyclophosphamide group,
△P＜0.01.
3. Chinese medicine compound is to the influence of H22 hepatocarcinoma transplanted tumor mice serum IL-2, TNF-a content
Treatment is organized 2 serum il-2 level apparently higher than model group, and difference has significance meaning (P＜0.05).
Treatment group 1 is organized 2 serum TNFs-a level with treatment and is starkly lower than model group, and difference has significance meaning (P＜0.05).
Treatment is organized 2 serum il-2 level apparently higher than treatment group 1 and treatment group 3, and difference all has significance meaning (P＜0.05), but compares with the cyclophosphamide group, and difference does not have significance meaning (P＞0.05).See table 3.
Table 3. Chinese medicine compound is to the influence
of H22 hepatocarcinoma transplanted tumor mice serum IL-2, TNF-a content
Annotate: compare * P＜0.05, * * P＜0.01 with model group; Compare #P＜0.05 with treatment group 1 and treatment group 3.Compare with the cyclophosphamide group,
△P＜0.05.
(3) conclusion
This compound Chinese medicinal preparation has the effect of better inhibited tumor growth to H22 hepatocarcinoma transplanted tumor mice; Especially best with the therapeutic effect of treatment group 2; The Chinese medicinal components dosage ratio of prompting embodiment 2 is preferable, and its mechanism of action is closely related with the TNF-a level of regulating immunologic function, rising mice serum IL-2 level, inhibition rising.
Claims (3)
1. Chinese medicine preparation of treating hepatocarcinoma, said preparation is made up of active ingredient and medical science acceptable auxiliary, it is characterized in that,
Described active ingredient is processed by following raw materials by weight percent medicine:
Cacumen Securinegae Suffruticosae 5-30%, Radix Sophorae Flavescentis 5-20%, Herba Rabdosiae Lophanthoidis 5-30%, Radix Notoginseng 4-10%, Radix Salviae Miltiorrhizae 5-25%, Semen Persicae 4-15%, Radix Bupleuri 4-10%, Fructus Ligustri Lucidi 5-25%, Herba Ecliptae 5-25%, Radix Pseudostellariae 2-25%, Radix Glycyrrhizae 2-10%;
The method for preparing of described active ingredient is made up of following steps:
(1) with the crude drug cutting, pulverize, add 8～12 times 60% ethanol, homogenate, centrifugal, obtain centrifugal liquid and centrifugal slag;
(2) centrifugal liquid that step (1) is made is successively through ceramic membrane filter element and the ultrafiltration of 10Kda filter element; First then reverse osmosis concentration reclaims the extractum that ethanol and vacuum concentration become to be equivalent to contain in every liter of extractum 1.5～2kg crude drug again to being equivalent to contain 0.8～1.2kg crude drug in every liter of concentrated solution;
10～20 times water mix homogeneously of the centrifugal slag that (3) step (1) is made and the total amount of said crude drug; Stirring furnishing slurry; Homogenate; Through ceramic membrane filter element and the ultrafiltration of 10Kda filter element, reverse osmosis concentration must be equivalent to contain in every liter of concentrated solution the concentrated solution of 2～4kg crude drug successively for centrifugal removing slag, centrifugal liquid;
(4) step (2) extractum that makes and the concentrated solution that step (3) is made are merged, mix, through the filtering of ceramic membrane filter element, spray drying promptly gets.
2. a kind of Chinese medicine preparation of treating hepatocarcinoma according to claim 1 is characterized in that the weight proportion of described crude drug is:
Cacumen Securinegae Suffruticosae 12.5%, Herba Rabdosiae Lophanthoidis 12.5%, Radix Sophorae Flavescentis 10.4%, Radix Notoginseng 4.2%, Radix Salviae Miltiorrhizae 12.5%, Semen Persicae 4.2%, Radix Bupleuri 4.2%, Fructus Ligustri Lucidi 12.5%, Herba Ecliptae 12.5%, Radix Pseudostellariae 12.5%, Radix Glycyrrhizae 2.0%.
3. a kind of Chinese medicine preparation of treating hepatocarcinoma according to claim 1 and 2 is characterized in that said preparation is granule, tablet or capsule.
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| CN104586990B (en) * | 2015-01-30 | 2017-04-19 | 广州泽力医药科技有限公司 | Preparation method of anti-hepatoma Chinese medicinal effective part composition |
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| CN1814049A (en) * | 2005-11-14 | 2006-08-09 | 广州泽力医药科技有限公司 | Compound traditional Chinese medicine for treating chronic liver disease and preparation |
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