CN102526230B - Traditional Chinese composition for curing liver disease and preparation method, quality detection method and application thereof - Google Patents

Traditional Chinese composition for curing liver disease and preparation method, quality detection method and application thereof Download PDF

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CN102526230B
CN102526230B CN2012100201069A CN201210020106A CN102526230B CN 102526230 B CN102526230 B CN 102526230B CN 2012100201069 A CN2012100201069 A CN 2012100201069A CN 201210020106 A CN201210020106 A CN 201210020106A CN 102526230 B CN102526230 B CN 102526230B
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chinese medicine
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CN102526230A (en
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付立家
付建家
马云
赵敏姿
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Beijing Youan Hospital
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Beijing Asia East Bio Pharmaceutical Co Ltd
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Abstract

The invention relates to a traditional Chinese composition for curing liver disease and a preparation method, a quality detection method and application thereof. The traditional Chinese composition contains the following raw materials of 200 parts to 500 parts of turtle shell, 350 parts to 650 parts of radix paeoniae rubra, 350 parts to 650 parts of astragalus mongholicus, 100 parts to 400 parts of rhizoma atractylodis macrocephalae, 100 parts to 400 parts of angelica sinensis, 350 parts to 650 parts of salvia miltiorhiza and 40 parts to 300 parts of semen cassiae and further contains selfheal. The traditional Chinese composition for curing liver disease is excellent in effect on curing chronic hepatitis and cirrhosis, quick in effect, accurate in curative effect, high in curing rate, convenient to take and better than the prior art.

Description

A kind of Chinese medicine composition, its preparation method and detection method and application for the treatment of hepatopathy
Technical field
The present invention relates to the field of Chinese medicines, particularly, relate to a kind of Chinese medicine composition for the treatment of hepatopathy, and its preparation method and quality determining method and application.
Background technology
Hepatopathy refers to occur in the pathological changes of liver.Comprise hepatitis, liver cirrhosis, fatization, hepatocarcinoma, the hepatic diseases such as alcoholic liver.The great disease of a kind of common hazardness, should be take active prevention as main.Hepatitis refers to the infectious disease that is caused by hepatitis virus, is divided at present first, second, third, fourth and penta type.Clinical commonly first type and B-mode two types.Primary disease is mainly by the contact peroral infection, and hepatitis B is more to be infected because of the virulent blood of input tape and blood product.Chronic hepatitis is many is failed due in time treatment or acute hepatitis protracted course of disease by acute hepatitis.Main manifestations is in various degree weak, loss of appetite, and abdominal distention, dull pain in liver, hepatomegaly etc., often increase the weight of because of overworked.Liver cirrhosis is for a long time, repeatedly to damage liver by multiple harmful factor to cause a kind of chronic disease of liver distortion, quality hardening.Especially more easily develop into liver cirrhosis with B-mode and the third type, fourth type chronic hepatitis.Other are as malnutrition due to long-term lacking protein, vitamin B group etc., chronic alcoholism due to being addicted to drink for a long time, Long Term Contact or the application of some chemical substances such as arsenic, cinchophen, isoniazid or medicine, and circulatory disturbance, schistosomicide etc. all can be damaged liver and thoroughly send out liver cirrhosis.Its early symptom is very similar to chronic hepatitis.Can cause the serious symptoms such as anemia, edema late period because of hypofunction of liver or portal hypertension.At present, the medicine of western medical treatment chronic hepatitis roughly has two classes clinically: 1. antiviral drugs, and as interferon, acycloguanosine; 2. immunostimulant, as specific immune ribonucleic acid, thymosin, Coriolous Dersicolor (Fr.) Quel, polyporusum bellatus etc.Treatment to liver cirrhosis there is no specific short and specific medicament at present clinically, the supporting treatments of suiting the medicine to the illness that adopt in treatment more, and common drug has amino acid, ATP, coenzyme A, insulin etc., but it is expensive that these medicines obviously exist, and toxic and side effects is large, the shortcomings such as easy recurrence.The dialectical method that treats of many employings on tcm clinical practice, prescription commonly used has Herba Artemisiae Scopariae Decoction, Yinchen Wuling San, Powder of Oriental Wormwood and Five Drugs with Poria, Radix Bupleuri liver soothing potion etc., but that these medicines obviously exist the course for the treatment of is long, dose is large, disease takes effect slow, takes the shortcoming such as inconvenient and make the patient lose the confidence for the treatment of, owing to can not in time be cured, and patient's work, study, life are greatly affected, and happiness, the harmony of family life have been had a strong impact on.
Chinese patent application CN200810158223.5 discloses a kind of medicine (prescription 1) for the treatment of hepatic cirrhosis with hypoproteinemia after hepatitis, it is the medicament of being made by the raw material of Chinese medicine of following weight parts: Radix Astragali 25-35, Radix Codonopsis 10-20, Colla Corii Asini 10-20, Radix Angelicae Sinensis 15-25, Radix Paeoniae Alba 10-20, Radix Rehmanniae 10-20, Radix Salviae Miltiorrhizae 25-35, Rhizoma Atractylodis Macrocephalae 30-100, Radix Aucklandiae 5-15, Fructus Lycii 5-15, Radix Paeoniae Rubra 10-90, Fructus Polygoni Orientalis 25-35, Radix Pseudostellariae 10-20, Carapax Trionycis 5-15, Radix Bupleuri 5-15, Concha Arcae 5-15, Poria 15-30, Fructus Setariae Germinatus (parched) 5-15, Rhizoma Curcumae 5-15.
Chinese patent application CN200710131358.8 discloses a kind of Chinese medicine for the treatment of liver cirrhosis.Main formula agent (prescription 2): Radix Angelicae Sinensis 15 grams, Radix Salviae Miltiorrhizae 30 grams, Radix Paeoniae Rubra 15 grams, Semen Persicae 8 grams, Carapax Trionycis (processed with vinegar) 15 grams, stir-baked SQUAMA MANITIS 10 grams, the Radix Astragali 30 grams, the Rhizoma Atractylodis Macrocephalae 15 grams, Poria 20 grams, Semen Plantaginis 15 grams, Pericarpium Arecae 20 grams, Fructus Lycii 12 grams, Herba Epimedii 10 grams, Herba Artemisiae Scopariae 15 grams, Radix Bupleuri 6 grams, Fructus Aurantii 9 grams, Radix Et Rhizoma Rhei 6 grams, Herba Hedyotidis Diffusae 30 grams; Auxiliary prescription: the obvious person of pain in the right hypochondrium adds Rhizoma Corydalis 12 grams, Radix Curcumae 12 grams; Sick prolonged deficiency damages severe patient and adds Radix Ginseng Rubra 6 grams, Colla Corii Asini bead 12 grams; The epistaxis person adds Radix Notoginseng 3 grams, Folium Callicarpae Formosanae 15 grams, Herba Agrimoniae 12 grams; Cold cold extremities person adds Radix Aconiti Lateralis Preparata 10 grams, Cortex Cinnamomi 3 grams.
Chinese patent application CN99109619.3 discloses a kind of hepatitis B and rheumatoid medicine (prescription 3) for the treatment of, by the pharmaceutical methods preparation routinely of following 38 kinds of raw materials: Formica fusca, Carapax Trionycis, rhizoma sparganic (processed with wine, Radix et Rhizoma Rhei (processed with wine), Semen Persicae, the Trionyx sinensis Wiegmann worm, Armadillidium, Folium Pyrrosiae, Herba Dianthi, Radix campsis, the Rhizoma Pinelliae, Radix Bupleuri, Radix Codonopsis, the Radix Astragali, Herba Hedyotidis Diffusae, Radix Isatidis, Radix Salviae Miltiorrhizae, Radix Scrophulariae, the Radix Paeoniae Alba, the Radix Rehmanniae, the Rhizoma Atractylodis Macrocephalae, Rhizoma Polygoni Cuspidati, Fructus Toosendan, Rhizoma Coptidis, Spica Prunellae, Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Dioscoreae, Sang Jisheng, Pericarpium Citri Reticulatae, Endothelium Corneum Gigeriae Galli, Radix Paeoniae Rubra, Cortex Moutan, Flos Carthami, Radix Curcumae, Rhizoma Curcumae, Concha Ostreae, Radix Ginseng.
Above-mentioned prescription flavour of a drug are many, and cost is high, to the patient, increases financial burden.And all with the present invention, larger difference is being arranged aspect curative effect or monarch compatibility.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine composition for the treatment of hepatopathy.
Another object of the present invention is to provide a kind of preparation method of described Chinese medicine composition.
Another object of the present invention is to provide a kind of quality determining method of described Chinese medicine composition.
Another object of the present invention is to provide the application of described Chinese medicine composition in preparation treatment liver disease drug.
A kind of Chinese medicine composition for the treatment of hepatopathy provided by the invention, comprise the raw material of Chinese medicine medicine of following weight portion: Carapax Trionycis 200-500 part, Radix Paeoniae Rubra 350-650 part, Radix Astragali 350-650 part, Rhizoma Atractylodis Macrocephalae 100-400 part, Radix Angelicae Sinensis 100-400 part, Radix Salviae Miltiorrhizae 350-650 part and Semen Cassiae 40-300 part.
Chinese medicine composition of the present invention preferably, comprises the raw material of Chinese medicine medicine of following weight portion: Carapax Trionycis 250-450 part, Radix Paeoniae Rubra 400-600 part, Radix Astragali 400-600 part, Rhizoma Atractylodis Macrocephalae 150-350 part, Radix Angelicae Sinensis 150-350 part, Radix Salviae Miltiorrhizae 400-600 part and Semen Cassiae 90-260 part.
Chinese medicine composition of the present invention, more preferably, comprise the raw material of Chinese medicine medicine of following weight portion: Carapax Trionycis 300-400 part, Radix Paeoniae Rubra 450-550 part, Radix Astragali 450-550 part, Rhizoma Atractylodis Macrocephalae 200-300 part, Radix Angelicae Sinensis 200-300 part, Radix Salviae Miltiorrhizae 450-550 part and Semen Cassiae 120-200 part.
Chinese medicine composition of the present invention most preferably, comprises the raw material of Chinese medicine medicine of following weight portion: 333 parts of Carapax Trionycis, 500 parts of Radix Paeoniae Rubra, 500 parts of the Radixs Astragali, 250 parts of the Rhizoma Atractylodis Macrocephalaes, 250 parts of Radix Angelicae Sinensis, 167 parts of 500 parts of Radix Salviae Miltiorrhizaes and Semen Cassiaes.
Chinese medicine composition of the present invention, also comprise Spica Prunellae.
Wherein, the weight portion of Spica Prunellae is 40-300 part, is preferably 90-260 part, and more preferably 120-200 part, most preferably be 167 parts.
Chinese medicine composition of the present invention, preferably, comprise the raw material of Chinese medicine medicine of following weight portion: Carapax Trionycis 250-450 part, Radix Paeoniae Rubra 400-600 part, Radix Astragali 400-600 part, Rhizoma Atractylodis Macrocephalae 150-350 part, Radix Angelicae Sinensis 150-350 part, Radix Salviae Miltiorrhizae 400-600 part, Semen Cassiae 90-260 part and Spica Prunellae 90-260 part.
Chinese medicine composition of the present invention, more preferably, comprise the raw material of Chinese medicine medicine of following weight portion: Carapax Trionycis 300-400 part, Radix Paeoniae Rubra 450-550 part, Radix Astragali 450-550 part, Rhizoma Atractylodis Macrocephalae 200-300 part, Radix Angelicae Sinensis 200-300 part, Radix Salviae Miltiorrhizae 450-550 part, Semen Cassiae 120-200 part and Spica Prunellae 120-200 part.
Chinese medicine composition of the present invention most preferably, comprises the raw material of Chinese medicine medicine of following weight portion: 333 parts of Carapax Trionycis, 500 parts of Radix Paeoniae Rubra, 500 parts of the Radixs Astragali, 250 parts of the Rhizoma Atractylodis Macrocephalaes, 250 parts of Radix Angelicae Sinensis, 500 parts of Radix Salviae Miltiorrhizaes, 167 parts of 167 parts of Semen Cassiaes and Spica Prunellaes.
Wherein, described Carapax Trionycis is Carapax Trionycis (processed), and Semen Cassiae is Semen Cassiae (parched).
Chinese medicine composition of the present invention, also comprise adjuvant.
Wherein, described adjuvant is selected from one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and substrate etc.
Described solvent is purified water.
Described disintegrating agent is selected from citric acid, sodium bicarbonate, lactose, hydroxyethyl-cellulose, one or more in carboxymethyl starch sodium (CMS-Na) or cross-linked pvp (polyvidone).
Described correctives is Aspartane or cyclamate.
Described antiseptic is parabens or sodium benzoate.
Described binding agent is selected from dextrin (starch slurry), cross-linking sodium carboxymethyl cellulose, one or more in microcrystalline Cellulose low-substituted hydroxypropyl cellulose or crospolyvinylpyrrolidone.The while cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose low-substituted hydroxypropyl cellulose or crospolyvinylpyrrolidone also can be used as disintegrating agent.
Described lubricant is micropowder silica gel, magnesium stearate or sodium lauryl sulphate.
Described substrate is Polyethylene Glycol (PEG6000 or PEG4000).
The consumption of adjuvant of the present invention is the 0.2-600 weight portion.
Chinese medicine composition of the present invention, its dosage form are pharmaceutically acceptable dosage form: granule, tablet, capsule, oral liquid or drop pill.
Wherein, described tablet can make conventional tablet, effervescent tablet or dispersible tablet.
The preparation method of above-mentioned Chinese medicine composition provided by the invention comprises: described raw material of Chinese medicine medicine is decocted with water, and decocting liquid filters, and filtrate decompression is condensed into thick paste.
The preparation method of Chinese medicine composition of the present invention further, comprises the following steps:
1) Carapax Trionycis is first used decocting 1-2 hour;
2) all the other raw material of Chinese medicine medicines decoct with water 1-3 time, each 0.5-2 hour, and collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (45-65 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, adds adjuvant, makes corresponding preparations.
In said method:
During described step 1) with the decocting Carapax Trionycis, the consumption of water is 6-8 times of Carapax Trionycis.
Described step 2) while decocting with water, the consumption of water is 6-8 times of described all the other whole raw material of Chinese medicine medicines.
The quality determining method of above-mentioned Chinese medicine composition provided by the invention comprises one or more in following discrimination method:
(1) get above-mentioned Chinese medicine composition 10g, porphyrize, add methanol 30ml, heating and refluxing extraction 1h, filter the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, with water saturated n-butyl alcohol jolting, extracts 2 times, each 20ml, merge n-butyl alcohol liquid, wash with water 2 times, each 20ml, discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue adds ethanol 1ml, as need testing solution; Separately get the peoniflorin reference substance, add ethanol and make every 1ml and contain the solution of 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take 40: 5: 10: chloroform-ethyl acetate of 0.2-methanol-formic acid was developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.Fasten the discriminating of stating Radix Paeoniae Rubra in Chinese medicine composition.
(2) get above-mentioned Chinese medicine composition 10g, porphyrize, add methanol 20ml, heating and refluxing extraction 1h, filter the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, regulate pH to 2 with dilute hydrochloric acid, with the ether jolting, extract 2 times, each 20ml, merge ether solution, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Separately get protocatechuic acid, protocatechualdehyde reference substance, add methanol and make every 1ml and contain the mixed solution of 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take 4: 3: 6: chloroform-ethyl acetate of 1-benzene-formic acid was developing solvent, launch, take out, dry, spray is with 5% ferric chloride alcoholic solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.Fasten the discriminating of stating Radix Salviae Miltiorrhizae in Chinese medicine composition.
(3) get above-mentioned Chinese medicine composition 10g, porphyrize, add methanol 50ml, put in water-bath reflux 1 hour, and let cool, filter, get filtrate 30ml, evaporate to dryness, residue add water 10ml makes dissolving, add again hydrochloric acid 1ml, put in water-bath and heated 30 minutes, cooling immediately, extract 2 times with the ether jolting, each 20ml, merge ether solution, evaporate to dryness, residue add chloroform 1ml makes dissolving as need testing solution; Separately get physcione, chrysophanol reference substance, add methanol and make 1ml and contain the mixed solution of 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw above-mentioned two kinds of solution 5ul, put respectively on same silica gel g thin-layer plate, take the upper solution of the petroleum ether-Ethyl formates of 15: 5: 1-formic acid as developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; Described petroleum ether is 30-60 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, aobvious identical orange-yellow fluorescence speckle; Put in the ammonia steam smoked after, inspect under daylight, speckle becomes redness.Fasten the discriminating of stating Semen Cassiae in Chinese medicine composition.
(4) get described Chinese medicine composition 10g, add methanol 20ml, reflux 1 hour, filter, filtrate is added on 100-120 order, 5g, on the neutral alumina column of internal diameter 10-15mm,, with 40% methanol 100ml eluting, collect eluent, evaporate to dryness, residue adds water 30ml makes dissolving, with water saturated n-butanol extraction 2 times, each 20ml, merge n-butyl alcohol liquid; Wash each 20ml with water 2 times; Discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Separately get the astragaloside reference substance, add methanol and make every 1ml and contain the solution of 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw reference substance solution 2 μ l, each 5 μ l of need testing solution and negative sample solution, put respectively on same silica gel g thin-layer plate, take 20: 40: 22: lower floor's solution of chloroform-ethyl acetate of 10-methanol-water is developing solvent, launches, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing at 105 ℃ clear.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, aobvious identical sepia speckle under daylight, aobvious identical orange-yellow fluorescence speckle under the 365nm ultra-violet lamp.Fasten the discriminating of stating the Radix Astragali in Chinese medicine composition.
The present invention also provides the application of above-mentioned Chinese medicine composition in preparation treatment liver disease drug.Especially the application in preparation treatment chronic hepatitis, liver cirrhosis medicine.
In Chinese medicine composition provided by the invention:
Carapax Trionycis: become, be slightly cold, return liver, kidney channel.Nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving, bring down a fever except steaming.Be used for fever due to yin deficiency, consumptive fever hectic fever due to YIN-deficiency, stirring-up of pathogenic wind in the interior resulting from deficiency, amenorrhea , WEIJIA, chronic malaria malaria with splenomegaly.
Radix Paeoniae Rubra: sour, bitter, cool.Contain peoniflorin (Paeoniflorin) in Radix Paeoniae Rubra.Clearing away heat and cooling blood, eliminating stasis to stop pain.Be used for maculae caused by violent heat pathogen, hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI, amenorrhea dysmenorrhea, lump in the abdomen stomachache, injury from falling down, carbuncle skin infection.
The Radix Astragali: sweet, tepor, return lung, spleen, liver, kidney channel.Contain astragaloside.There are benefiting QI for strengthening the superficies, arresting sweating admittedly to take off, hold in the palm the effect of skin ulcer granulation promoting, inducing diuresis to remove edema.Be used for the treatment of the deficiency of vital energy weak, sinking of QI of middle-JIAO, the chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, the exterior deficiency spontaneous perspiration, carbuncle is difficult bursts, and burst and do not hold back for a long time, blood deficiency and yellow complexion, interior-heat is quenched one's thirst, chronic nephritis, albuminuria, diabetes etc.
The Rhizoma Atractylodis Macrocephalae: bitter, sweet, temperature, return spleen, stomach warp.Invigorating the spleen and benefiting QI, the dampness diuretic, hidroschesis, antiabortive.Be used for insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement
Radix Angelicae Sinensis: warm in nature, sweet in the mouth, suffering.Return liver, the heart, spleen channel.Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.Be used for blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores.
Radix Salviae Miltiorrhizae: hardship is slightly cold; GUIXIN, Liver Channel.Root contains protocatechualdehyde (protocatechuic aldehyde) and protocatechuic acid.Promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, nourishing blood to tranquillize the mind.Cure mainly menoxenia, the amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.
Semen Cassiae, also be Semen Cassiae.Hardship, be slightly cold.Seed contains anthraquinone analog compound, is mainly physcione, chrysophanol.Clearing away heat to improve acuity of vision, loosening bowel to relieve constipation.Be used for the puckery pain of conjunctival congestion, the many tears of photophobia, have a headache dizzy, poor vision, constipation.Return liver, kidney, large intestine channel.The effect that fat-reducing is arranged.Control the wind heat acute conjunctivitis, optic atrohic blindness, nyctalopia, hypertension, hepatitis, cirrhotic ascites, habitual constipation.
Spica Prunellae: bitter, acrid, cold.The improving eyesight of relieving inflammation or internal heat: control conjunctival congestion and swelling pain, headache; Clearing away liver-fire, blood pressure lowering; Mass dissipating and swelling eliminating: control scrofula, goiter, acute mastitis and swell and ache.
Chinese medicine composition of the present invention, take Carapax Trionycis as monarch.Carapax Trionycis Cheng Ping, YIN nourishing hard masses softening and resolving, with the same use of drug for invigorating blood circulation and eliminating stasis, to eliminate lump.Radix Paeoniae Rubra, the Radix Astragali are minister.Radix Paeoniae Rubra is the product of blood circulation promoting and blood stasis dispelling, with the monarch drug compatibility, can play the effect of benefiting QI for activating blood circulation.The sweet temperature QI invigorating of the Radix Astragali, with Zhi Qiben.The Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Semen Cassiae are assistant.Wherein the bitter sweet temperature of the Rhizoma Atractylodis Macrocephalae, enter the taste warp, invigorating the spleen and replenishing QI, biochemical former to help.The Radix Salviae Miltiorrhizae nourshing blood and promoting blood circulation,, with the monarch drug compatibility, can strengthen the function that our benefiting QI and nourishing blood is invigorated blood circulation.The liver body is cloudy, and with the passing of time hepatopathy, easily consumes impairing the liver blood with sun, thus invigorate blood circulation with Chinese Angelica blood replonishing, with the nourishing the liver easing the affected liver.Especially with Semen Cassiae bitter cold, hot with clear eliminating pathogen in the liver.
Further, Spica Prunellae enters Liver Channel, again can the repercussive eliminating stagnation, therefore making for we.
The all medicines of Chinese medicine composition of the present invention share, and play altogether benefiting QI for activating blood circulation, the effect of hard masses softening and resolving.Function cures mainly: benefiting QI for activating blood circulation, hard masses softening and resolving.The syndrome of blood stasis due to qi deficiency that is used for chronic hepatitis, early stage liver cirrhosis, disease are seen the lower lump of the side of body, stitch in the side, and fatigue and weakness, dim complexion, the red thread of erythema, tongue is dark or ecchymosis, deep-thready pulse arranged.
Through clinical experience for many years, finally determined the present invention, experimental result shows: the invention provides Chinese medicine composition and can be used for treating hepatopathy, especially excellent for chronic hepatitis, liver cirrhosis effect, instant effect, determined curative effect, cure rate is high, taking convenience, be better than prior art, has no adverse reaction.And flavour of a drug are few, and cost is low.
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Stock and adjunct used in the present invention, all can buy and obtain on market.
Embodiment 1: granule
1, Chinese medicine composition forms: Carapax Trionycis 333g, Radix Paeoniae Rubra 500g, Radix Astragali 500g, Rhizoma Atractylodis Macrocephalae 250g, Radix Angelicae Sinensis 250g, Radix Salviae Miltiorrhizae 500g and Semen Cassiae 167g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1.5 hours, and the consumption of water is 7 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 3 times, each 1 hour (consumption that at every turn decocts water is 7 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (60 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, adds dextrin 500g, the granulation agent.
Embodiment 2: granule
1, Chinese medicine composition forms: Carapax Trionycis 333g, Radix Paeoniae Rubra 500g, Radix Astragali 500g, Rhizoma Atractylodis Macrocephalae 250g, Radix Angelicae Sinensis 250g, Radix Salviae Miltiorrhizae 500g, Semen Cassiae 167g and Spica Prunellae 167g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1 hour, and the consumption of water is 8 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water twice, each 1 hour (consumption that at every turn decocts water is 8 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, adds dextrin 520g, uses the ethanol granulation, and drying, make 1000g, obtains.
Embodiment 3: conventional tablet
1, Chinese medicine composition forms: Carapax Trionycis 300g, Radix Paeoniae Rubra 550g, Radix Astragali 450g, Rhizoma Atractylodis Macrocephalae 200g, Radix Angelicae Sinensis 200g, Radix Salviae Miltiorrhizae 450g, Semen Cassiae 120g and Spica Prunellae 120g.
2, preparation method:
1) Carapax Trionycis was first used decocting 2 hours, and the consumption of water is 8 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 2 times, each 1 hour (consumption that at every turn decocts water is 8 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, granulates, and adds magnesium stearate 10g, is pressed into 100,000, obtains.
Embodiment 4: capsule
1, Chinese medicine composition forms: Carapax Trionycis 400g, Radix Paeoniae Rubra 450g, Radix Astragali 450g, Rhizoma Atractylodis Macrocephalae 300g, Radix Angelicae Sinensis 200g, Radix Salviae Miltiorrhizae 550g, Semen Cassiae 200g and Spica Prunellae 120g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1 hour, and the consumption of water is 6 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 2 times, each 1 hour (consumption that at every turn decocts water is 6 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, adds dextrin 20g, mixes, and incapsulates 100,000, obtains.
Embodiment 5: drop pill
1, Chinese medicine composition forms: Carapax Trionycis 250g, Radix Paeoniae Rubra 400g, Radix Astragali 600g, Rhizoma Atractylodis Macrocephalae 150g, Radix Angelicae Sinensis 150g, Radix Salviae Miltiorrhizae 600g, Semen Cassiae 90g and Spica Prunellae 90g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1 hour, and the consumption of water is 8 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 2 times, each 1 hour (consumption that at every turn decocts water is 6.5 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, adds PEG4000: 100g; PEG6000: 500g, make drop pill, makes 1000g, obtains.
Embodiment 6: oral liquid
1, Chinese medicine composition forms: Carapax Trionycis 450g, Radix Paeoniae Rubra 600g, Radix Astragali 400g, Rhizoma Atractylodis Macrocephalae 350g, Radix Angelicae Sinensis 350g, Radix Salviae Miltiorrhizae 400g, Semen Cassiae 260g and Spica Prunellae 260g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1 hour, and the consumption of water is 6 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 1 time, and 2 hours (consumption that decocts water is 8 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) thick paste adds sodium benzoate 2g, adds purified water and adjusts total amount to 1000 parts by volume, obtains.
Embodiment 7: effervescent tablet
1, Chinese medicine composition forms: Carapax Trionycis 200g, Radix Paeoniae Rubra 650g, Radix Astragali 350g, Rhizoma Atractylodis Macrocephalae 100g, Radix Angelicae Sinensis 100g, Radix Salviae Miltiorrhizae 650g, Semen Cassiae 40g and Spica Prunellae 40g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1 hour, and the consumption of water is 8 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 2 times, each 0.5 hour (consumption that at every turn decocts water is 7.5 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, with the gas-producing disintegrant of extract powder and 300g (citric acid/sodium bicarbonate=1: 0.9), the lactose of 200g, the hydroxyethyl-cellulose of 20g, granulate with dehydrated alcohol after mixing, the mobility that adds the micropowder silica gel adjusting granule of 10g, tabletting, make 10000 effervescent tablets, obtains.
Embodiment 8: dispersible tablet
1, Chinese medicine composition forms: Carapax Trionycis 500g, Radix Paeoniae Rubra 350g, Radix Astragali 650g, Rhizoma Atractylodis Macrocephalae 400g, Radix Angelicae Sinensis 400g, Radix Salviae Miltiorrhizae 350g, Semen Cassiae 300g and Spica Prunellae 300g.
2, preparation method:
1) Carapax Trionycis was first used decocting 1 hour, and the consumption of water is 8 times of Carapax Trionycis;
2) all the other raw material of Chinese medicine medicines decoct with water 2 times, each 1 hour (consumption that at every turn decocts water is 8 times of described all the other whole raw material of Chinese medicine medicines), collecting decoction, filter, and filtrate decompression concentrates and obtains the thick paste that relative density is 1.30-1.35 (50 ℃ of survey);
3) drying under reduced pressure or spray drying, be ground into fine powder, adds crospolyvinylpyrrolidone 200g, cross-linking sodium carboxymethyl cellulose 100g, microcrystalline Cellulose 30g, low-substituted hydroxypropyl cellulose 100g, mix homogeneously; With dry pressing granulate, 16 order granulate, add magnesium stearate 10g, mix homogeneously, be pressed into 10000 and get final product.
Test example 1: discrimination method
(1) get embodiment 2 Chinese medicine composition 10g, porphyrize, add methanol 30ml, heating and refluxing extraction 1h, filter the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, with water saturated n-butyl alcohol jolting, extracts 2 times, each 20ml, merge n-butyl alcohol liquid, wash with water 2 times, each 20ml, discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue adds ethanol 1ml, as need testing solution; Separately get the peoniflorin reference substance, add ethanol and make every 1ml and contain the solution of 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take 40: 5: 10: chloroform-ethyl acetate of 0.2-methanol-formic acid was developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.Fasten the discriminating of stating Radix Paeoniae Rubra in Chinese medicine composition.
(2) get embodiment 2 Chinese medicine composition 10g, porphyrize, add methanol 20ml, heating and refluxing extraction 1h, filter the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, regulate pH to 2 with dilute hydrochloric acid, with the ether jolting, extract 2 times, each 20ml, merge ether solution, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Separately get protocatechuic acid, protocatechualdehyde reference substance, add methanol and make every 1ml and contain the mixed solution of 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take 4: 3: 6: chloroform-ethyl acetate of 1-benzene-formic acid was developing solvent, launch, take out, dry, spray is with 5% ferric chloride alcoholic solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.Fasten the discriminating of stating Radix Salviae Miltiorrhizae in Chinese medicine composition.
(3) get embodiment 2 Chinese medicine composition 10g, porphyrize, add methanol 50ml, put in water-bath reflux 1 hour, and let cool, filter, get filtrate 30ml, evaporate to dryness, residue add water 10ml makes dissolving, add again hydrochloric acid 1ml, put in water-bath and heated 30 minutes, cooling immediately, extract 2 times with the ether jolting, each 20ml, merge ether solution, evaporate to dryness, residue add chloroform 1ml makes dissolving as need testing solution; Separately get physcione, chrysophanol reference substance, add methanol and make 1ml and contain the mixed solution of 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw above-mentioned two kinds of solution 5ul, put respectively on same silica gel g thin-layer plate, take the upper solution of the petroleum ether-Ethyl formates of 15: 5: 1-formic acid as developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; Described petroleum ether is 30-60 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, aobvious identical orange-yellow fluorescence speckle; Put in the ammonia steam smoked after, inspect under daylight, speckle becomes redness.Fasten the discriminating of stating Semen Cassiae in Chinese medicine composition.
(4) get embodiment 2 Chinese medicine composition 10g, add methanol 20ml, reflux 1 hour, filter, filtrate is added on 100-120 order, 5g, on the neutral alumina column of internal diameter 10-15mm,, with 40% methanol 100ml eluting, collect eluent, evaporate to dryness, residue adds water 30ml makes dissolving, with water saturated n-butanol extraction 2 times, each 20ml, merge n-butyl alcohol liquid; Wash each 20ml with water 2 times; Discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Separately get the astragaloside reference substance, add methanol and make every 1ml and contain the solution of 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010), draw reference substance solution 2 μ l, each 5 μ l of need testing solution and negative sample solution, put respectively on same silica gel g thin-layer plate, take 20: 40: 22: lower floor's solution of chloroform-ethyl acetate of 10-methanol-water is developing solvent, launches, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing at 105 ℃ clear.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, aobvious identical sepia speckle under daylight, aobvious identical orange-yellow fluorescence speckle under the 365nm ultra-violet lamp.Fasten the discriminating of stating the Radix Astragali in Chinese medicine composition.
The compositions of other embodiment is carried out corresponding discriminating detect, up to specification equally.
Test example 2
According to " pertinent regulations under Chinese pharmacopoeia version (an one) appendix IC granule item in 2010, check embodiment 2 Chinese medicine compositions.Result is as follows:
1, granularity: except as otherwise herein provided, according to granulometry (appendix XI B the second method, two sieve methods), measure, can not by No. one with can pass through the summation of sieving for No. five, must not cross 15%.Check result: up to specification.
2, moisture: according to " Chinese pharmacopoeia version (an one) appendix IX H aquametry operation in 2010, check embodiment 2 Chinese medicine compositions.Standard is decided to be: moisture must not cross 6.0%.Check result: up to specification.
3, content uniformity: according to " operating under the content uniformity check item in Chinese pharmacopoeia version (an one) appendix IC granule in 2010, the content uniformity of embodiment 2 Chinese medicine compositions is checked.Check result: up to specification.
4, melting: according to " operating under the melting check item in Chinese pharmacopoeia version (an one) appendix IC granule in 2010, the melting (disintegration) of embodiment 2 Chinese medicine compositions is checked.Check result: up to specification.
5, get embodiment 2 Chinese medicine compositions appropriate, according to microbial limit test (" appendix XIII C of Chinese pharmacopoeia version in 2010), check.Result: microbial limit meets " Chinese pharmacopoeia regulation.
Measurement result:
1) bacterium liquid group colony counting (cfu):
Staphylococcus aureus: 81; Bacillus subtilis: 76; Escherichia coli: 64; Aspergillus niger: 67; Candida albicans 82;
2) test sample matched group colony counting (cfu):
Bacterial population (1: 10): 0; Yeast and mold number (1: 10): 0.
3) test group colony counting (cfu):
Staphylococcus aureus: 66-72; Bacillus subtilis: 64-69; Escherichia coli: 54-59; Aspergillus niger: 54-59; Candida albicans: 69-74.
4) test group determination of recovery rates result (response rate %):
Staphylococcus aureus: 81-89; Bacillus subtilis: 84-91; Escherichia coli: 84-92; Aspergillus niger: 81-88; Candida albicans: 84-90.
6, n-butyl alcohol extractum: get embodiment 2 Chinese medicine compositions, porphyrize, get 4g, accurately weighed, measure according to the hot dipping under water-soluble extractives algoscopy item (appendix XA of Chinese Pharmacopoeia version in 2010), make solvent with water-saturated n-butanol, this product is pressed dry product and is calculated, and contains the n-butyl alcohol extractum and must not be less than 8%.
Compositions to other embodiment is carried out corresponding detection, and is up to specification equally.
Test example 3: on pharmacologically active impact test
The composition of this test liver-protecting tablet used is as follows: Radix Bupleuri 250g, Herba Artemisiae Scopariae 250g, Radix Isatidis 250g, Fructus Schisandrae Chinensis 300g, Pulvis Fellis Suis 20g and Semen phaseoli radiati 128g.
1, reduce the ALT rising that carbon tetrachloride infringement rat liver causes
Wister rat body weight 148.0 ± 31.0g.Male and female are regardless of, and random packet is divided into: what be left intact is the blank group, CCl 4Group, liver-protecting tablet group, the corresponding of the present invention group of 1-8 of the Chinese medicine composition of embodiment of the present invention 1-8; Wherein of the present invention group 2 is divided into again: of the present invention group of 2-1, of the present invention group of 2-2 and of the present invention group of 2-3, respectively corresponding embodiment 2 Chinese medicine compositions low, in and high dose group.
CCl 4Group, the liver-protecting tablet group, of the present invention group of 1-8 is in the 1st, 4,7 day difference ih carbon tetrachloride 5ml/kg of experiment.Of the present invention group of 1-8 is respectively at the Chinese medicine composition of the 1st day tested embodiment of the present invention 1-8 of ig listed dosage in table 1, and continuous 9 days, broken end was got blood in the 10th day.With UV-256FW spectrophotometric determination ALT.The results are shown in Table 1.
The impact of table 1 the present invention on the rat ALT of hepatic injury
Figure BDA0000132941280000151
Figure BDA0000132941280000161
Annotate: * compares * P<0.05, * * P<0.01 with the CCL4 group; △ compares P<0.05 with the liver-protecting tablet group.
2, improve the level of lipidperoxidation mouse liver cell pigment P-450
LACA Mouse Weight 20-24g.The male and female dual-purpose, random packet.Be divided into: distilled water group, liver-protecting tablet group, the corresponding of the present invention group of 1-8 of the Chinese medicine composition of embodiment of the present invention 1-8.
The 1st group of (being the distilled water group) ig distilled water 20ml/kg, 2-11 group (the capable group of 2-11 in table 2) is respectively at the 1st, 4 day ih carbon tetrachloride 2.5ml/kg of experiment, cause liver damaged, distinguished simultaneously ig distilled water 20ml/kg from the 2nd day, liver-protecting tablet group 2.5g/kg, of the present invention group of (1-8) 2.5g/kg, continuous 7 days, one day 1 time, after drug withdrawal, fasting is 18 hours, puts to death animal.Suddenly get liver.The sticking liquid of dehematizing, prepare sample, and the content with 721 spectrophotometric instrumentation liver cell pigment P-450, the results are shown in Table 2.
The impact of table 2 the present invention on LACA mouse liver cell pigment P-450
Figure BDA0000132941280000162
Figure BDA0000132941280000171
Annotate: * compares * P<0.05, * * P<0.01 with the CCL4 group; △ compares P<0.05 with the liver-protecting tablet group; △ △ P<0.01.
3, the impact of the present invention on immunologic function rising immune organs of rats weight in wet base
The SD rat, body weight 140.0 ± 30.0g, male and female dual-purpose, random packet.Be divided into: distilled water group, liver-protecting tablet group, the corresponding of the present invention group of 1-8 of the Chinese medicine composition of embodiment of the present invention 1-8; Wherein of the present invention group 2 is divided into again: of the present invention group of 2-1, of the present invention group of 2-2 and of the present invention group of 2-3, respectively corresponding embodiment 2 Chinese medicine compositions low, in and high dose group.
The 1st group of (being the distilled water group) ig distilled water 20ml/kg/ day, listed corresponding dosage in 2-12 group (the capable group of 2-12 in table 3) ig table 3, continuous 9 days, every Mus is iv sheep red blood cell (SRBC) 1.2ml/ on the the 7th, 10 (about 2,000,000,000 erythrocyte/ml) only separately.9th, only, after ip soluble starch on the 10th 1 hour, ip1% chicken red blood cell 3ml/ only, extracted peritoneal exudate and surveys the macrophage phagocytic percentage rate after 5 hours for each ip1% soluble starch 5ml/ on the 10th.Heart extracting blood on the 10th, separation of serum, survey respectively sheep red blood cell (SRBC) HD50, T lymhocyte transformation rate, wins respectively simultaneously thymus and spleen and claim its weight in wet base with 1/0,000 balances.Check through F, the results are shown in Table 3.
Table 3 the present invention is on the impact of normal immune organs of rats weight in wet base (X ± SD)
Figure BDA0000132941280000181
Annotate: * compares * P<0.05, * * P<0.01 with the distilled water group; △ compares P<0.05 with the liver-protecting tablet group.
Conclusion: the present invention can obviously reduce the ALT rising that carbon tetrachloride infringement animal causes, can raise low-level by the liver cell pigment P-450 content that produces after the carbon tetrachloride infringement, and liver is had certain protective effect; Can improve thymus, spleen weight in wet base to the immunologic function degression rat, immunologic enhancement is arranged.And effect is better than the liver-protecting tablet of selling on market.

Claims (9)

1. Chinese medicine composition for the treatment of hepatopathy, it is characterized in that, raw material of Chinese medicine medicine by following weight portion forms: Carapax Trionycis 200-500 part, Radix Paeoniae Rubra 350-650 part, Radix Astragali 350-650 part, Rhizoma Atractylodis Macrocephalae 100-400 part, Radix Angelicae Sinensis 100-400 part, Radix Salviae Miltiorrhizae 350-650 part, Semen Cassiae 40-300 part and Spica Prunellae 40-300 part.
2. Chinese medicine composition according to claim 1, it is characterized in that, raw material of Chinese medicine medicine by following weight portion forms: Carapax Trionycis 250-450 part, Radix Paeoniae Rubra 400-600 part, Radix Astragali 400-600 part, Rhizoma Atractylodis Macrocephalae 150-350 part, Radix Angelicae Sinensis 150-350 part, Radix Salviae Miltiorrhizae 400-600 part, Semen Cassiae 90-260 part and Spica Prunellae 90-260 part.
3. Chinese medicine composition according to claim 1, it is characterized in that, raw material of Chinese medicine medicine by following weight portion forms: Carapax Trionycis 300-400 part, Radix Paeoniae Rubra 450-550 part, Radix Astragali 450-550 part, Rhizoma Atractylodis Macrocephalae 200-300 part, Radix Angelicae Sinensis 200-300 part, Radix Salviae Miltiorrhizae 450-550 part, Semen Cassiae 120-200 part and Spica Prunellae 120-200 part.
4. Chinese medicine composition according to claim 3, is characterized in that, the raw material of Chinese medicine medicine of following weight portion, consists of: 333 parts of Carapax Trionycis, 500 parts of Radix Paeoniae Rubra, 500 parts of the Radixs Astragali, 250 parts of the Rhizoma Atractylodis Macrocephalaes, 250 parts of Radix Angelicae Sinensis, 500 parts of Radix Salviae Miltiorrhizaes, 167 parts of 167 parts of Semen Cassiaes and Spica Prunellaes.
5. according to claim 1-4 described Chinese medicine compositions of any one, is characterized in that, described Chinese medicine composition also comprises adjuvant.
6. Chinese medicine composition according to claim 5, is characterized in that, its dosage form is granule, tablet, capsule, oral liquid or drop pill.
7. the preparation method of the described Chinese medicine composition of claim 1-6 any one, is characterized in that, comprising: described raw material of Chinese medicine medicine is decocted with water, and decocting liquid filters, and filtrate decompression is condensed into thick paste.
8. the detection method of the described Chinese medicine composition of claim 1-6 any one, is characterized in that, comprises one or more in following discrimination method:
(1) get above-mentioned Chinese medicine composition 10g, porphyrize, add methanol 30ml, heating and refluxing extraction 1h, filter the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, with water saturated n-butyl alcohol jolting, extracts 2 times, each 20ml, merge n-butyl alcohol liquid, wash with water 2 times, each 20ml, discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue adds ethanol 1ml, as need testing solution; Separately get the peoniflorin reference substance, add ethanol and make every 1ml and contain the solution of 1mg, in contrast product solution.According to the thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take chloroform-ethyl acetate of 40:5:10:0.2-methanol-formic acid as developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing;
(2) get above-mentioned Chinese medicine composition 10g, porphyrize, add methanol 20ml, heating and refluxing extraction 1h, filter the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, regulate pH to 2 with dilute hydrochloric acid, with the ether jolting, extract 2 times, each 20ml, merge ether solution, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Separately get protocatechuic acid, protocatechualdehyde reference substance, add methanol and make every 1ml and contain the mixed solution of 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take chloroform-ethyl acetate of 4:3:6:1-benzene-formic acid as developing solvent, launch, take out, dry, spray is with 5% ferric chloride alcoholic solution, and it is clear that hot blast blows to the speckle colour developing;
(3) get above-mentioned Chinese medicine composition 10g, porphyrize, add methanol 50ml, put in water-bath reflux 1 hour, and let cool, filter, get filtrate 30ml, evaporate to dryness, residue add water 10ml makes dissolving, add again hydrochloric acid 1ml, put in water-bath and heated 30 minutes, cooling immediately, extract 2 times with the ether jolting, each 20ml, merge ether solution, evaporate to dryness, residue add chloroform 1ml makes dissolving as need testing solution; Separately get physcione, chrysophanol reference substance, add methanol and make 1ml and contain the mixed solution of 1mg, in contrast product solution; According to thin layer chromatography test, draws above-mentioned two kinds of solution 5ul, put respectively on same silica gel g thin-layer plate, launch as developing solvent take the upper solution of petroleum ether-Ethyl formate of 15:5:1-formic acid, taking-up, dry, and puts under the 365nm ultra-violet lamp and inspect; Described petroleum ether is 30-60 ℃;
(4) get described Chinese medicine composition 10g, add methanol 20ml, reflux 1 hour, filter, filtrate is added on 100-120 order, 5g, on the neutral alumina column of internal diameter 10-15mm,, with 40% methanol 100ml eluting, collect eluent, evaporate to dryness, residue adds water 30ml makes dissolving, with water saturated n-butanol extraction 2 times, each 20ml, merge n-butyl alcohol liquid; Wash each 20ml with water 2 times; Discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Separately get the astragaloside reference substance, add methanol and make every 1ml and contain the solution of 1mg, in contrast product solution; Test according to thin layer chromatography, draw reference substance solution 2 μ l, each 5 μ l of need testing solution and negative sample solution, put respectively on same silica gel g thin-layer plate,, take lower floor's solution of chloroform-ethyl acetate of 20:40:22:10-methanol-water as developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing at 105 ℃ clear.
9. the application of the described Chinese medicine composition of claim 1-6 any one in preparation treatment liver disease drug.
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Inventor after: Fu Lijia

Inventor before: Fu Lijia

Inventor before: Fu Jianjia

Inventor before: Ma Jun

Inventor before: Zhao Minzi

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Effective date of registration: 20240308

Address after: No. 8, West End, Youanmenwai, Fengtai District, Beijing, 100069

Patentee after: Beijing Youan Hospital, Capital Medical University

Country or region after: China

Address before: 102200, 8, Zhenxing Road, Changping District science and Technology Park, Beijing

Patentee before: BEIJING ASIA-EAST BIO-PHARMACEUTICAL Co.,Ltd.

Country or region before: China

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