CN105456728A - Application of medicine composition to preparation of medicine for treating hepatobiliary calculus - Google Patents

Application of medicine composition to preparation of medicine for treating hepatobiliary calculus Download PDF

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CN105456728A
CN105456728A CN201610043744.0A CN201610043744A CN105456728A CN 105456728 A CN105456728 A CN 105456728A CN 201610043744 A CN201610043744 A CN 201610043744A CN 105456728 A CN105456728 A CN 105456728A
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medicine
radix
calculus
pharmaceutical composition
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李金霞
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Qingdao Huazhicao Medical Technology Co Ltd
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Qingdao Huazhicao Medical Technology Co Ltd
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Abstract

The invention belongs to the technical field of medicine and relates to application of a medicine composition to preparation of medicine for treating hepatobiliary calculus. The application of the medicine composition to preparation of the medicine for treating hepatobiliary calculus aims at making up the deficiencies of the prior art and alleviating pain of a patient suffering from hepatobiliary calculus. The medicine composition is prepared from cape jasmine, scutellaria baicalensis, great burdock achene, pinellia ternata, ligusticum wallichii, epimedium herbs, pseudo-ginseng, radix scrophulariae, astragalus membranaceus, radix angelica sinensis, spina date seeds, angelica dahurica, rhizoma corydalis, circium japonicum and Indian iphigenia bulbs. The medicine composition for treating hepatobiliary calculus has the remarkable analgesic activity and the calculus-dissolving and calculus-removing effects, is reliable in curative effect, safe and reliable and has wide clinical application prospect.

Description

The purposes of a kind of pharmaceutical composition in preparation treatment liver and bile stone medicine
The application is the divisional application of the application for a patent for invention (denomination of invention is: a kind of medical composition and its use for the treatment of liver and bile stone and renal calculus, and application number is: 2014101134643, and the applying date is: on March 25th, 2014) that applicant Cui Xinming proposes.
Technical field
The invention belongs to medical art, relate to the purposes of a kind of pharmaceutical composition in preparation treatment liver and bile stone medicine.
Background technology
Cholelithiasis is the commonly encountered diseases of biliary system, accounts for the 20%-30% of Surgical Acute Venter Diseases.In recent years, along with the raising of living standards of the people and the day by day perfect of inspection method, particularly Type B are ultrasonic, since the application clinically such as CT, to the Diagnosis and Treat means of biliary tract, all provided accurate and effective therapeutic scheme.Epidemiological study shows, dietary constituents occupies very important position to the formation of calculus and change.The report system at China's cholelithiasis end of the thirties to beginning of the sixties based on bile pigment calculus, especially in rural area.But national cholelithiasis analyzing specimen points out China's cholelithiasis type to have a very large change in recent years, and the ratio of cholesterol calculus has exceeded bile pigment calculus, and this is relevant with the change of our people's dietary structure.Meanwhile, in zoopery, also prove the fat content in keeping on a diet or the relative scale of fatty acid and protein, can have an impact to the quantity of calculus and composition.To the understanding of cholelithiasis, since oneth century of past, all concentrate on the various changes that extrahepatic biliary passages local occurs, think that extrahepatic biliary passages is the place producing calculus.But after having had " causing stone sexually transmitted disease (STD) reason bile " this concept, when especially finding that extrahepatic biliary passages pathological changes still exists sending out again of pathology bile and calculus after Surgery Treatment, people turn in liver gradually to the understanding of cholelithiasis, think that to be liver by the effect of enzyme or metabolic deficiency produce and cause stone sexually transmitted disease (STD) reason bile, thus form calculus.
Many clinical datas show that cholelithiasis is a kind of disease relevant with liver in recent years, and cholelithiasis patient has liver disease damage to a certain degree.These results of study, rule together with Chinese traditional treatment cholelithiasis liver and gall, liver spleen theory of ruling together have play the same tune on different musical instruments wonderful.Motherland's medical science thinks the gallbladder being attached to the liver, and liver and gall are the exterior and the interior each other, and gallbladder is the fu-organ that contains refined juice, built-in refined juice, and bile derives from the residual air of liver.Liver department catharsis function, dredges function of gallbladder promoting juice, and all catharsis, courage affecting liver is led to the factor of falling function and all can be caused cholestasis, decocts with the passing of time, bile deposition and form sandstone.Liver controlling conveyance and dispersion, The spleen has the function to transport and transform nutrients, and the transportation capabilities of spleen must be achieved under the catharsis effect of liver is coordinated.Upper work preventing diseases instead for the treatment of diseases, is shown in the disease of liver, knowing the liver disease will be transmitted into the spleen, in the ban tonifying the spleen.So theory that in the treatment of cholelithiasis, liver and gall of should applying in a flexible way are ruled together, liver spleen is ruled together, makes therapeutic effect more perfect.
Liver, cholelithiasis belong to the category of the diseases such as the traditional Chinese medical science " rib tumor " " stomachache " " stomachache ".Etiology and pathogenesis mostly is depression of liver-QI, the liver losing its smoothly moving state, the gallbladder being attached to the liver, and gallbladder loses catharsis, qi depression to blood stasis, damp and hot retardance, pents up petrochemical industry, decocts into calculus, and stagnate biliary tract, liver and gall mechanism of qi is not changed, so for suffering from.Cholecystitis belongs to the traditional Chinese medical science " gallbladder-distention " category.Main syndromes has right flank pain, bitter taste, sighing frequently, and accompany nauseating, belch, abdominal distention etc., easy recurrent exerbation, its diseased region at gallbladder, but has substantial connection with liver simultaneously.Liver and gallbladder the exterior and the interior each other, " gallbladder is fu-viscera with clear juice, hides bile and reduces to suitable to turn dredging ", bile is " by means of the residual air of liver, corner enters gallbladder, gathers and forms ", and its function relies on the catharsis of liver, promotes transporting and transforming function of the spleen and stomach again.Feelings will is unsuccessful, surfeit is greasy, irregular diet etc. all can affect suffocating of liver and gall and transporting and transforming function of the spleen and stomach, and QI stagnation of the liver and galibladder then bile excretion is smooth, dysfunction of the spleen in transportation then retention of damp-heat in the interior, and stagnation of QI internal organs closes and causes logical the falling of gallbladder internal organs mechanism of qi and not normally then become cholecystitis.Modern medicine still lacks specific medicament and promising approach to the treatment of cholecystitis.A large amount of Clinical and experimental studies shows, Chinese medicine cholecystitis has greater advantage, controls gallbladder mainly with soothing the liver for reaching, reason spleen be with.Traditional Chinese medical science traditional theory thinks that the liver failing to maintain the normal flow of QI, gallbladder lose logical falling, and cholestasis can cause calculus and generate; And damp and hot, that the stagnation of QI, blood stasis are liver and bile stone disease three principal characters, treatment focuses on embodiment and " leads to, falls " two words, with depressed liver-energy dispersing and function of gallbladder promoting, heat clearing and blood stasis dispersing, promoting the circulation of QI capable stagnant, capture calculus for principle.
At present, the sickness rate of liver, cholelithiasis rises gradually, adopts operative therapy both at home and abroad to the treatment of cholelithiasis more, but the removal of Post operation retained calculus is comparatively difficult.Be used for the treatment of liver in the patent medicine of existing Chinese and Western, the medicine of gallstone disease and complication thereof has: mostly gallbladder health, JINDAN PIAN, Os Gallus domesticus blade, XIAOYAN LIDAN PIAN etc., be that the inflammation acting on body of gallbladder and biliary tract changes.Through clinical observation, the therapeutic effect of this kind of medicine is poor, and cure rate is low, can only relief of symptoms and can not curing.
Summary of the invention
In order to make up the deficiencies in the prior art, alleviate the misery of liver and bile stone patient, it is evident in efficacy, safe and reliable to the invention provides a kind of pharmaceutical composition for the treatment of liver and bile stone, has wide potential applicability in clinical practice.
Technical scheme of the present invention is: a kind of pharmaceutical composition for the treatment of liver and bile stone, and this pharmaceutical composition is made up of the raw material of following weight portion: Fructus Gardeniae 10-12, Radix Scutellariae 5-8, Fructus Arctii 6-9, Rhizoma Pinelliae 3-5, Rhizoma Chuanxiong 10-12, Herba Epimedii 3-5, Radix Notoginseng 3-5, Radix Scrophulariae 10-12, Radix Astragali 8-10, Radix Angelicae Sinensis 6-9, Semen Ziziphi Spinosae 10-12, Radix Angelicae Dahuricae 10-12, Rhizoma Corydalis 10-12, Radix Cirsii Japonici 12-15, Pseudobulbus Cremastrae Seu Pleiones 9-12.
In pharmaceutical composition described above, ursodesoxycholic acid 5-8 part and Rhizoma Atractylodis Macrocephalae 12-15 part can also be contained.These two kinds of Chinese medicines can strengthen analgesic effect and the calculus dissolving and excreting effect of aforementioned pharmaceutical compositions of the present invention further.
The present invention also asks to protect the purposes of aforementioned pharmaceutical compositions in preparation treatment liver and bile stone medicine.The purposes of pharmaceutical composition in preparation treatment liver and bile stone medicine, described pharmaceutical composition is made up of the raw material of following weight portion: Fructus Gardeniae 10 parts, Radix Scutellariae 5 parts, Fructus Arctii 6 parts, the Rhizoma Pinelliae 3 parts, Rhizoma Chuanxiong 10 parts, Herba Epimedii 3 parts, Radix Notoginseng 3 parts, Radix Scrophulariae 10 parts, the Radix Astragali 8 parts, Radix Angelicae Sinensis 6 parts, Semen Ziziphi Spinosae 10 parts, the Radix Angelicae Dahuricae 10 parts, Rhizoma Corydalis 10 parts, Radix Cirsii Japonici 12 parts, Pseudobulbus Cremastrae Seu Pleiones 9 parts.
[embodiment of the present invention 7 shows, mice licks foot response latency time showing, compare with model group, after administration after 1h and 2h, the incubation period that the mice of each administration group of pharmaceutical composition of the present invention adds foot reaction is all greater than model group, there is dose-dependence, and be significantly greater than model group (P < 0.05) incubation period of high dose group.What illustrate that this pharmaceutical composition of the present invention can extend that mice stimulates hot plate adds the sufficient response latency, has certain analgesic activity.Under same experiment condition, hydrocortisone group (P < 0.05) also extends the incubation period that mice adds foot reaction, has certain analgesic activity, but its analgesic effect and model group there was no significant difference.The embodiment of the present invention 8 shows, and each treatment group of pharmaceutical composition of the present invention and positive controls have the effect significantly reducing Ca, TBIL, DBIL level in bile and the effect raising BA level.Wherein the regulating action of positive controls and low group of the present composition close.In the present composition group and high group compared with positive controls reduce Ca, TBIL, DBIL level and rising BA in bile horizontal in there is the difference of significance.Based on this, pharmaceutical composition of the present invention also has certain therapeutic effect for renal calculus.
In order to express pharmaceutical composition of the present invention better, pharmaceutical composition of the present invention can be prepared into dosage form conventional clinically.Such as, the preparations such as powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsule, described pharmaceutical preparation all can prepare according to Chinese medicine preparation preparation method well-known to those skilled in the art.Preferably, pharmaceutical composition of the present invention conveniently preparation technology be prepared into powder, water preparation, tablet or capsule.
Present invention also offers a kind of preparation method of pharmaceutical composition described above, it mainly comprises following step: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, the alcoholic solution that volumetric concentration is 40%-95% is doubly added according to the 4-9 of coarse powder gross weight, reflux, extract, three times, return time is 2-5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Those skilled in the art can technically prepare conventional Chinese medicine pharmaceutical dosage form clinically, as tablet, capsule etc. in this preparation method.
The present invention is that inventor is through repeatedly studying, progressively improve, last successful a kind of curative effect treats the medicine of liver and bile stone preferably, for showing the therapeutic effect of medicine of the present invention to liver and bile stone, the present invention has carried out clinical observation to the liver and bile stone patient that 180 examples take this medicine, and selection has liver and bile stone patient 179 example of comparability as a control group.Treatment group patient takes medicine twice of the present invention every day, and sooner or later respectively once, once take 5 grams of medicines, matched group patient takes the oral drugs of conventional therapy liver and bile stone.Treat after one month, therapeutic outcome is in table 1.
Table 1 treatment group and treatment of control group result synopsis
Treatment group is compared matched group and is had higher cure rate and effective percentage, thinks thus, and Drug therapy liver and bile stone of the present invention has good effect, and through the Ureteral Calculus of month, takes medicine of the present invention and do not occur any toxic and side effects.
Pharmaceutical composition of the present invention, in treatment liver and bile stone, compared with prior art has following advantage:
1) compared with the chemotherapeutic agent of Current therapeutic, pharmaceutical composition of the present invention is natural pure Chinese medicinal preparation, and untoward reaction and side effect significantly reduce, and pharmaceutical composition effect of the present invention is comprehensive, and therapeutic effect is better, and improves the quality of life of patient.
2) contain multi-medicament component in pharmaceutical composition of the present invention, pharmacological evaluation shows it and existing gallstone treatment medicine has significant synergism in lithodialysis.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but those skilled in the art should know, described embodiment does not also limit the present invention in any way.
One) example of formulations part
Embodiment 1 pharmaceutical composition of the present invention and preparation technology
The weight portion of Chinese medicinal components: Fructus Gardeniae 10, Radix Scutellariae 5, Fructus Arctii 6, the Rhizoma Pinelliae 3, Rhizoma Chuanxiong 10, Herba Epimedii 3, Radix Notoginseng 3, Radix Scrophulariae 10, the Radix Astragali 8, Radix Angelicae Sinensis 6, Semen Ziziphi Spinosae 10, the Radix Angelicae Dahuricae 10, Rhizoma Corydalis 10, Radix Cirsii Japonici 12, Pseudobulbus Cremastrae Seu Pleiones 9.
Get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, doubly add according to the 4-9 of coarse powder gross weight the alcoholic solution that volumetric concentration is 40%-95%, reflux, extract, three times, return time is 2-5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Those skilled in the art can technically prepare conventional Chinese medicine pharmaceutical dosage form clinically, as tablet, capsule etc. in this preparation method.
Embodiment 2 pharmaceutical composition of the present invention and preparation technology
The weight portion of Chinese medicinal components: Fructus Gardeniae 12, Radix Scutellariae 8, Fructus Arctii 9, the Rhizoma Pinelliae 5, Rhizoma Chuanxiong 12, Herba Epimedii 5, Radix Notoginseng 5, Radix Scrophulariae 12, the Radix Astragali 10, Radix Angelicae Sinensis 9, Semen Ziziphi Spinosae 12, the Radix Angelicae Dahuricae 12, Rhizoma Corydalis 12, Radix Cirsii Japonici 15, Pseudobulbus Cremastrae Seu Pleiones 12.
Preparation method is with embodiment 1.
Embodiment 3 pharmaceutical composition of the present invention and preparation technology
The weight portion of Chinese medicinal components: Fructus Gardeniae 11, Radix Scutellariae 7, Fructus Arctii 7, the Rhizoma Pinelliae 4, Rhizoma Chuanxiong 11, Herba Epimedii 4, Radix Notoginseng 4, Radix Scrophulariae 11, the Radix Astragali 9, Radix Angelicae Sinensis 8, Semen Ziziphi Spinosae 11, the Radix Angelicae Dahuricae 11, Rhizoma Corydalis 11, Radix Cirsii Japonici 13, Pseudobulbus Cremastrae Seu Pleiones 10.
Preparation method is with embodiment 1.
Embodiment 4 pharmaceutical composition of the present invention and preparation technology
The weight portion of Chinese medicinal components: Fructus Gardeniae 10, Radix Scutellariae 5, Fructus Arctii 6, the Rhizoma Pinelliae 3, Rhizoma Chuanxiong 10, Herba Epimedii 3, Radix Notoginseng 3, Radix Scrophulariae 10, the Radix Astragali 8, Radix Angelicae Sinensis 6, Semen Ziziphi Spinosae 10, the Radix Angelicae Dahuricae 10, Rhizoma Corydalis 10, Radix Cirsii Japonici 12, Pseudobulbus Cremastrae Seu Pleiones 9, ursodesoxycholic acid 5, the Rhizoma Atractylodis Macrocephalae 13 parts.
Preparation method is with embodiment 1.
Embodiment 5 pharmaceutical composition of the present invention and preparation technology
The weight portion of Chinese medicinal components: Fructus Gardeniae 12, Radix Scutellariae 8, Fructus Arctii 9, the Rhizoma Pinelliae 5, Rhizoma Chuanxiong 12, Herba Epimedii 5, Radix Notoginseng 5, Radix Scrophulariae 12, the Radix Astragali 10, Radix Angelicae Sinensis 9, Semen Ziziphi Spinosae 12, the Radix Angelicae Dahuricae 12, Rhizoma Corydalis 12, Radix Cirsii Japonici 15, Pseudobulbus Cremastrae Seu Pleiones 12, ursodesoxycholic acid 8 parts, the Rhizoma Atractylodis Macrocephalae 12.
Preparation method is with embodiment 1.
Embodiment 6 pharmaceutical composition of the present invention and preparation technology
The weight portion of Chinese medicinal components: Fructus Gardeniae 11, Radix Scutellariae 7, Fructus Arctii 7, the Rhizoma Pinelliae 4, Rhizoma Chuanxiong 11, Herba Epimedii 4, Radix Notoginseng 4, Radix Scrophulariae 11, the Radix Astragali 9, Radix Angelicae Sinensis 8, Semen Ziziphi Spinosae 11, the Radix Angelicae Dahuricae 11, Rhizoma Corydalis 11, Radix Cirsii Japonici 13, Pseudobulbus Cremastrae Seu Pleiones 10, ursodesoxycholic acid 6 parts, the Rhizoma Atractylodis Macrocephalae 15.
Preparation method is with embodiment 1.
(2) test examples part
Embodiment 7 pharmaceutical composition of the present invention affects mouse hot-plate analgesic
1 mouse hot-plate pain model makes
About body weight 20g female mice is placed on hot plate dolorimeter, screen qualified ♀ mice 90 (to lick metapedes time < 5s or > 30s to throw aside, scald for preventing foot, also deadline should be established, be generally 60s), the incubation period of metapedes reaction is added for threshold of pain index with mice, get 60 jennies, be divided into 5 groups, 12/group, i.e. model group, hydrocortisone group, pharmaceutical composition of the present invention (obtaining by pharmaceutical composition prescription described in embodiment 1 and preparation technology) low dose group, middle dosage group and high dose group.Each group is gastric infusion, and 1 times/day, dosage is as shown in table 10, and after successive administration 14d, after measuring last medicine, 60min, 120min add the time of foot reaction.
2 pharmaceutical compositions of the present invention are on the impact of licking the foot response latency in mouse hot-plate analgesic experiment
Mice licks foot response latency time showing, compare with model group, after administration after 1h and 2h, the incubation period that the mice of each administration group of pharmaceutical composition of the present invention adds foot reaction is all greater than model group, there is dose-dependence, and be significantly greater than model group (P < 0.05) incubation period of high dose group.What illustrate that this pharmaceutical composition of the present invention can extend that mice stimulates hot plate adds the sufficient response latency, has certain analgesic activity.Under same experiment condition, positive control hydrocortisone group (P < 0.05) also extends the incubation period that mice adds foot reaction, has certain analgesic activity, but its analgesic effect and model group there was no significant difference.The results are shown in Table 2.
Table 2 mice lick foot response latency timetable ( )
Note: compare with model group, *p < 0.05, *p < 0.01.
Embodiment 8 the present invention is to lithodialysis, calculus, the anti-masonry use of Cavia porcellus cholesterol calculus model
1 materials and methods
1.1 laboratory animals: healthy guinea pig is selected in the experiment of lithodialysis, anti-stone, male, body weight 200-300g, totally 100, purchased from Liaoning University of TCM's laboratory animal Breeding Center, adopt mode of raising in cages.
1.2 modeling methods: adopt bait provocation method, chow diet is provided by Liaoning University of TCM's experimental animal feeding center, become the autogamy of stone feedstuff, formula is Semen Maydis powder 15%, analysis for soybean powder 10%, flour 10%, fish flour 3%, wheat bran 10%, Sal 1%, yeast powder 1%, alfalfa meal 40%, casein 2%, Adeps Sus domestica 2%, sucrose 5%, cholesterol 1%.Normal group throws normal diet 11 weeks, and model group and treatment group of the present invention first throw into stone feedstuff 7 weeks, after throw normal diet 4 weeks.Prevention group of the present invention throws into stone feedstuff 7 weeks.Every day thrown 250g by every cage, freely drink water (tap water), and feeds appropriate Radix Dauci Sativae.
1.3 Experimental agents: the drug combination preparation of the present invention prepared by embodiment 1.Treatment group first throws into stone feedstuff 7 weeks, rear throwing normal diet 4 weeks gastric infusion; Medicine all uses distilled water diluting, gavage gives Chinese medicine of the present invention respectively, combination object height group, middle group and low group are respectively containing pharmaceutical composition 2g, 1g, 0.5g of the present invention, positive controls every gavage chenodeoxy cholic acid 25mg, normal group and model group gavage with same volume distilled water, once daily when every day the morning 8.
1.4 methods of sample collection animal fasting (can't help water) 24h, lethal from eye socket injection air, cut rapidly breast abdomen open, expose heart, get cardiac blood with syringe and be about 3ml, then expose gallbladder, cystic duct is blocked by vascular forceps, take off gallbladder, first perusal becomes stone situation, and with the whole bile of syringe sucking-off.Bile and blood place 40min at normal temperatures, and then the centrifugal 10min of 2000r/pm, gets bile supernatant and serum, be positioned over preserve in-20 DEG C of refrigerators to be measured.
1.5 testing index methods: various index test all adopts clinical assay reagent box, buy in chemical reagents corporation of Beijing.Wherein T-CHOL and bile acid are enzymic colorimetric; Total bilirubin and bilirubin direct are chemical colorimetry; Calcium ion is sodium ethylene diamine tetracetate method.
1.6 statistical method: this experiment the data obtained utilizes SPSS8.0 statistical software to process, statistical method adopts chi-square analysis and t inspection.
1.7 experimental result
Modelling result: in model group 10 Cavia porcelluss, 8 form calculus, and this calculus profile is irregular, not of uniform size, taupe flake, quality is soft, frangible.Model group gallstone formation rate has highly significant difference (P < 0.01) compared with normal group.The impact of pharmaceutical composition of the present invention on composition every in bile is as shown in table 3.
Table 3 pharmaceutical composition of the present invention is on the impact of composition every in bile
Compare with normal group, ▲ ▲p < 0.01; Compare with model group *p < 0.05, *p < 0.01; Compare with positive controls, △p < 0.05.
As can be seen from Table 3, each treatment group of pharmaceutical composition of the present invention and positive controls have the effect significantly reducing Ca, TBIL, DBIL level in bile and the effect raising BA level.Wherein the regulating action of positive controls and low group of the present composition close.In the present composition group and high group compared with positive controls reduce Ca, TBIL, DBIL level and rising BA in bile horizontal in there is the difference of significance.

Claims (2)

1. the purposes of pharmaceutical composition in preparation treatment liver and bile stone medicine, is characterized in that described pharmaceutical composition is made up of the raw material of following weight portion: Fructus Gardeniae 10 parts, Radix Scutellariae 5 parts, Fructus Arctii 6 parts, the Rhizoma Pinelliae 3 parts, Rhizoma Chuanxiong 10 parts, Herba Epimedii 3 parts, Radix Notoginseng 3 parts, Radix Scrophulariae 10 parts, the Radix Astragali 8 parts, Radix Angelicae Sinensis 6 parts, Semen Ziziphi Spinosae 10 parts, the Radix Angelicae Dahuricae 10 parts, Rhizoma Corydalis 10 parts, Radix Cirsii Japonici 12 parts, Pseudobulbus Cremastrae Seu Pleiones 9 parts.
2. the purposes of pharmaceutical composition as claimed in claim 1 in preparation treatment liver and bile stone medicine, is characterized in that: described pharmaceutical composition is powder, water preparation, tablet or capsule.
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