CN101632829B - Anti-hepatofibrosis traditional Chinese medicament composition, preparation method thereof and medicament preparation - Google Patents

Abstract

The invention discloses an anti-hepatofibrosis traditional Chinese medicament composition and a preparation method thereof. The anti-hepatofibrosis traditional Chinese medicament composition is prepared by the following raw materials: bear gall powder, red sage root, curcumin and milk veteh. The anti-hepatofibrosis traditional Chinese medicament composition prepared by the preparation method can be prepared into any commonly used oral administration preparation, has obvious effects on treating hepatofibrosis, hepatitis, fatty liver, hepatocirrhosis and the like and has obvious medicament functions for protecting the liver, reducing aminotransferase and inhibiting the fibrosis of stem cells.

Description

Chinese medicine composition of a kind of anti-hepatic fibrosis and preparation method thereof and pharmaceutical preparation

Technical field

The present invention relates to a kind of Chinese patent medicine and preparation method thereof, particularly a kind of anti-hepatic fibrosis medicines composition and method of making the same.

Background technology

According to interrelated data, China is hepatopathy country occurred frequently, and 3,000 ten thousand chronic hepatitis B patient and 1.2 hundred million hepatitis B virus carrierss are arranged at present approximately, accounts for more than 10% of country's total population respectively.Hepatopathys such as viral hepatitis, hepatic fibrosis, fatty liver, alcoholic liver pathological changes, medicamentous liver lesion and hepatocarcinoma more and more become the principal disease that threatens compatriots' health in recent years.

Hepatic fibrosis (hepatic fibrosis) is a pathology notion of modern medicine, is meant diffusivity extracellular matrix (particularly collagen fiber) hyperplasia, deposition in the liver.It is not an independently disease, but many chronic hepatic diseases all can cause hepatic fibrosis, its cause of disease is broadly divided into infectivity (chronic type b, third type and hepatitis D, blood draws parasitosis etc.), inborn errors of metabolism (hepatolenticular degeneration, hemachromatosis, α1-Kang Yidanbaimeiquefazheng etc.) and chemical metabolization defective (chronic alcoholic liver disease, chronic drug-induced liver disease) and autoimmune hepatitis, constitutional liver juice liver cirrhosis and primary sclerosing cholangitis etc.Hepatic fibrosis is clinical to be main clinical manifestation with side of body portion distending pain, yellow cellulitis, the following long-pending piece of the side of body etc.

Clinically, the medicine of doctor trained in Western medicine anti-hepatic fibrosis is mainly interferon-alpha, lamivudine and adefovirdipivoxil.The clinical studies show interferon-alpha is concerning producing the degree that continues can to alleviate the hepatitis C patients that virusology replys its hepatic fibrosis after treatment.Interferon and ribavirin use in conjunction can be removed hepatitis C viruss more than half, and antiviral therapy also can improve the hepatic fibrosis process, and may reverse liver cirrhosis.Interferon-alpha treatment hepatitis B also can improve hepatic fibrosis, the index of hepatic fibrosis obviously descend (P＜0.05).

Lamivudine can effectively suppress duplicating of HBV DNA, and the serum conversion of part patient HBeAg/anti HBe is arranged.Treating 2 years heptic fibrosis has alleviating in various degree, or delays the process of hepatic fibrosis, but the main limitation of lamivudine is variation, and the incidence rate of 1 year and 5 years is respectively 15～32% and 67～69%.After variation, Histological change may increase the weight of.Adefovirdipivoxil also can improve the chronic viral hepatitis B fibrosis.

In recent years, the hepatic fibrosis gene therapy obtains bigger progress, but the subject matter that exists at present is targeting, expression efficiency that gene imports.Modulatory character and safety solve as yet fully, and therefore gene therapy really will be used for clinically may also need long process to reverse or to cure hepatic fibrosis.

In recent years, Chinese medicine hepatic fibrosis research has obtained bigger achievement, also demonstrates comparatively remarkable advantages.Though the record of no hepatic fibrosis name of disease in traditional Chinese medicine can belong to it sick categories such as " hypochondriac pain ", " yellow cellulitis ", " tympanites " in conjunction with clinical manifestation, in addition also can be with reference to diseases such as " mausoleum is long-pending ", " addiction blood ", " gathering ".Traditional Chinese medical theory thinks that the formation of hepatic fibrosis is also closely related with " positive QI-insufficiency ".Initial stage liver network blocks, and qi depression to blood stasis continues that then liver disease affecting spleen, deficiency-weakness of spleen-QI, and no resource of generating and transforming QI and blood on the one hand, positive QI-insufficiency, pathogen is easily crouched, and increases the weight of blood stasis; On the other hand, qi as the commander of blood, the deficiency of vital energy are then agitated unable, and blood is capable unsmooth and living in the blood stasis.In treatment, be auxilliary based on blood circulation promoting and blood stasis dispelling, supplementing QI and nourishing YIN, and in conjunction with the Therapeutic Principle of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, blood circulation promoting and blood stasis dispelling, strengthening the body resistance are the basic method of treatment of Chinese medicine anti-hepatic fibrosis.

The single medicinal material of treatment hepatic fibrosis at present mainly contains Radix Salviae Miltiorrhizae, Semen Persicae, Radix Angelicae Sinensis, Cordyceps, the Radix Astragali, Radix Bupleuri, Rhizoma Curcumae Longae, Typhonium flagelliforme (Lodd.) Blume and tetrandrine, salvianolic acid A, Semen Persicae extract, Cucurbitacin B, oleanolic acid, glycyrrhizin, enoxolone, atractylone etc.; The herbal mixture compositions has supporting vital QI and dispersing blood stasis side (Shanghai Univ. of Traditional Chinese Medicine), compound recipe 861 (Beijing Friendship Hospital), FUFANG BIEJIA RUANGAN PIAN (302 hospitals of PLA), liver-strengthening capsule (Academy of Traditional Chinese Medicine, Shanxi Province), the fine peaceful granule (Hunan College of Traditional Chinese Medicine) of liver, softening the hard mass syrup (Hubei College Of Traditional Chinese Medicine) etc.The Chinese medicine effect curative effect of treatment hepatic fibrosis at present is not remarkable, acts on singlely, and specific aim is relatively poor, and consumption is bigger than normal, costs an arm and a leg etc.

Summary of the invention

Primary and foremost purpose of the present invention is to provide a kind of pharmaceutical composition that is used for the treatment of hepatic fibrosis and preparation method thereof at the problem that above-mentioned prior art exists, said composition is at the cause of disease and the pathogenesis of hepatic fibrosis, utilize the mutual synergism of the active component of plurality of Chinese, pass through heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, the strengthening the body resistance anti-hepatic fibrosis, evident in efficacy.

For realizing purpose of the present invention, one aspect of the present invention provides a kind of Chinese medicine composition of anti-hepatic fibrosis, comprises that mainly following raw material makes: Fel Ursi powder, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, the Radix Astragali.

Wherein, the weight portion proportioning of the Chinese medicine composition raw material of described anti-hepatic fibrosis is:

Fel Ursi powder 1-10, Radix Salviae Miltiorrhizae 10-50, Rhizoma Curcumae Longae 20-100, Radix Astragali 30-200.

Particularly, the weight portion proportioning of described raw material is: Fel Ursi powder 1-5, Radix Salviae Miltiorrhizae 10-30, Rhizoma Curcumae Longae 30-60, Radix Astragali 50-80.

Especially, the weight portion proportion optimization of described raw material is: Fel Ursi powder 1, Radix Salviae Miltiorrhizae 20, Rhizoma Curcumae Longae 40, the Radix Astragali 60.

The Chinese medicine composition of anti-hepatic fibrosis of the present invention selects Fel Ursi powder, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, the Radix Astragali to carry out combined preparation and form, blood circulation promoting and blood stasis dispelling, strengthening the body resistance, heat-clearing and toxic substances removing, these Chinese crude drugs are used in combination, make the active component in each medical material produce synergism, mutual enhancement protects the liver, the effect of hepatoprotective, thereby can suppress, stop the fibrosis of liver organization effectively.

Wherein, the Fel Ursi of selecting for use is a monarch drug, has heat-clearing and toxic substances removing, and the effect that function of gallbladder promoting makes eye bright is aided with Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain; Assistant is with Radix Astragali strengthening the body resistance, plays blood circulation promoting and blood stasis dispelling altogether, sets upright QI invigorating, the effect of heat-clearing and toxic substances removing.

Fel Ursi is the dry bile of ursidae animal black bear, northeast brown bear or brown bear, and cold in nature, bitter in the mouth is returned liver, gallbladder, the heart, stomach warp, has that heat-clearing and toxic substances removing, suppressing the hyperactive liver make eye bright, parasite killing stops blooding, the effect of relieving convulsion, is mainly used in the treatment jaundice due to damp-heat; The heat-damp in summer dysentery; The calentura infantile convulsion; The conjunctival congestion cataracta; Sore throat; The nose erosion; Furuncle; Anal fistula; Infantile malnutrition; Ascarid, multiple hemorrhage.

The alkali metal salt, cholesterol and the bile pigments that mainly contain the bile acids in the Fel Ursi.Tauroursodeoxycholic acid that can about 20% in the Fel Ursi, tauroursodeoxycholic acid is hydrolyzed and then generates taurine and ursodeoxycholic acid.Fel Ursi also contains a spot of chenodeoxy cholic acid and cholic acid.Ursodeoxycholic acid is the stereoisomers of crane deoxycholic acid, is the special composition of Fel Ursi.

Modern pharmacological research shows that Fel Ursi has choleretic effect, and cholic acid can impel biliary flow to increase; Spasmolysis, the spasm of Fel Ursi to causing with acetylcholine has potent spasmolytic effect; The mice that ursodeoxycholic acid sodium in the Fel Ursi causes strychnine poisons Detoxication is arranged, and share with chenodeoxy cholic acid sodium and sodium cholate to strengthen its Detoxication; Fel Ursi has certain refrigeration function to Oleum Terebinthinae pyrogenicity; Hemophilus influenza, escherichia coli, streptococcus pneumoniae, alpha streptococcus, Pseudomonas aeruginosa, micrococcus catarrhalis etc. all there is inhibitory action.

Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae, cold nature, bitter in the mouth, and GUIXIN, Liver Channel have stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the clear away heart-fire effect of relieving restlessness is mainly used in menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris etc.

Contain liposoluble constituent in the Radix Salviae Miltiorrhizae: Tanshinone I, IIA, IIB, iso tanshinone I, IIA, cryptotanshinone, different cryptotanshinone, methyltanshinone, hydroxyl tanshinone, danshenxinkun A, B, C, dihydroisotanshinone I, new cryptotanshinone, remove the new cryptotanshinone of hydroxyl etc.; Water miscible phenol acid compound: Radix Salviae Miltiorrhizae acid A, B, C, salviol acid A, B, C, D, E, G, rosmarinic acid, rosmarinic acid methyl ester, alkannic acid mono methyl ester, alkannic acid dimethyl ester, alkannic acid ethyl ester, alkannic acid, protocatechualdehyde, caffeic acid, Hesperetic acid etc.

Radix Salviae Miltiorrhizae has protective effect to hepatocyte injury, and (1) Radix Salviae Miltiorrhizae can make the liver regeneration degree, and liver regeneration is subjected to the adjusting of multiple hormone, and especially insulin and glucagon have the effect of obvious promotion liver regeneration.It is relevant that the mechanism of action that Radix Salviae Miltiorrhizae makes liver cell regeneration and Radix Salviae Miltiorrhizae improve sanguimotor effect.Radix Salviae Miltiorrhizae is on the basis of whole body and the improvement of local organization blood circulation, the portal vein blood flow is increased, improve liver blood supply and nutrition, bring more insulin and glucagon simultaneously, promote liver regeneration, synthetic and the cell division propagation of DNA when Radix Salviae Miltiorrhizae Injection can promote liver regeneration promotes liver regeneration; (2) Radix Salviae Miltiorrhizae is to the effect of acute liver damage, the Treated with Radix Salviae Miltiorrhizae hepatic injury, and glutamate pyruvate transaminase (SGPT) vigor obviously reduces; Content of triglyceride obviously reduces in the liver; Radix Salviae Miltiorrhizae obviously alleviates hepatic necrosis and inflammatory reaction; (3) Radix Salviae Miltiorrhizae is to cirrhotic preventive and therapeutic effect, and Radix Salviae Miltiorrhizae promotes the degraded of collagen fiber obviously to reduce collagen content and serum r globulin content in the liver hardening process by the activity that increases collagenase content, enhancing collagenase.Hydroxyproline is the product of collagen degradation, discharges through urine, and hydroxyproline content improves in the urine; (4) Radix Salviae Miltiorrhizae is to the re-absorbed effect of liver fiber, and Radix Salviae Miltiorrhizae obviously alleviates the hepatic fibrosis of animal, and the liver collagen content significantly reduces.Illustrate that the medicine Radix Salviae Miltiorrhizae has the re-absorbed effect of the liver fiber of promotion, Radix Salviae Miltiorrhizae suppresses fibroplasia and promotes downright bad hepatocellular reparation relevant with regeneration in time with Radix Salviae Miltiorrhizae;

Scholar's research shows that Radix Salviae Miltiorrhizae can stimulate the rising of plasma fibronectin linking protein (PFN) level; thereby improve the phagocytic function and the OA of its netted interior layer system; prevent the immunologic injury of liver; reach the effect of protection hepatocyte and promotion liver cell regeneration; Radix Salviae Miltiorrhizae is not merely to improve liver microcirculation; supply with the useful factor of liver; the more important thing is that Radix Salviae Miltiorrhizae can improve the PFN level; strengthen reticuloendothelial system phagocytic function and OA; avoid the liver immunologic injury, finally play the protection hepatocyte and promote hepatocellular regeneration.

Rhizoma Curcumae Longae is the dry rhizome of zingiberaceous plant Rhizoma Curcumae Longae or Radix Curcumae, and is warm in nature, and bitter in the mouth, suffering are returned spleen, Liver Channel, have the removing blood stasis circulation of qi promoting, and the effect of inducing menstruation to relieve menalgia is used for the breast side of body and twinges, amenorrhea, WEIJIA, rheumatism shoulder arm pain, diseases such as tumbling and swelling.

The main chemical compositions of Rhizoma Curcumae Longae has (1) curcumin chemical compounds: curcumin, bisdemethoxycurcumin, demethoxycurcumin, dihydro curcumin etc.; (2) sesquiterpenoids: the new ketone of Rhizoma Curcumae Longae, Rhizoma Curcumae Longae keto-alcohol A, B, big Mang cattle ketone-13 aldehyde, former curcumadiol, cowherb are stated the dicyclo ketenes, and the dehydrogenation cowherb is stated diketone, α-turmerone etc.; (3) acidic polysaccharose: Rhizoma Curcumae Longae Polysaccharide A, B, C, D; (4) volatile oil: turmerone, zingerene, phellandrene, 1,8-cineole, sabinene, Borneolum Syntheticum, dehydroturmerone etc.;

Modern pharmacological research shows that Rhizoma Curcumae Longae decoct and preserved material can increase the bile secretion of dog, makes bile component recover normal, and increases the gallbladder contraction; Curcumin or its sodium salt have choleretic effect, and intravenous injection can reduce content, the increase choleresis of solid constituent, and cholate, bilirubin, cholesterol secretory volume all increase, and it is constant that fatty acid composition keeps.Curcumol or ether extract, curcumin and volatile oil are irritated stomach, experimental hyperlipidemia rat and rabbit all there is the effect of significantly falling total plasma cholesterol and B-lipoprotein, and can reduce liver cholesterol, it is out of proportion to correct a-and B-lipoprotein, the effect of falling plasma triglyceride is more being shown, can make that triglyceride is reduced to below the normal level in the blood plasma.It is heavy that filling stomach curcumin can reduce liver, reduce triglyceride, free fatty, content of phospholipid and the total triglyceride of serum, very low density lipoprotein (VLDL) (VLDL)+low density lipoprotein, LDL (LDL) triglyceride in the liver, the content of free fatty acid also can improve serum total cholesterol and HDL cholesterol level in the white triglyceride of high density lipoprotein level (HDL), VLDL+LDL cholesterol and the blood.Rhizoma Curcumae Longae also has antioxidation, and curcumin all has obvious antagonism to lipid peroxidation, and its antioxidation is higher than vitamin E.

The Radix Astragali is the dry root of leguminous plant Radix Astagali or Radix Astragali, and warm in nature, sweet in the mouth is returned lung, spleen channel, has invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, the function of expelling pus and promoting granulation, it is weak to be mainly used in the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, the exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, burst for a long time and do not hold back, the blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes etc.

The chemical constituent of the Radix Astragali is flavone and flavonoid glycoside: as calycosin, 2 ', and 4 ' dihydroxy-5,6-dimethoxy isoflavone, 3-hydroxyl-9,10-dimethoxy Lignum pterocarpi indici alkane, astragaloside I, V, III; Also contain the folic acid of a large amount of astragalus polysaccharidess and cupreol, linoleic acid, linolenic acid, choline, betanin, aminoacid, sucrose, glucuronic acid and trace etc.

The pharmacological research of the Radix Astragali shows that the Radix Astragali can strengthen normal heart and shrink, and the heart of depletion is had cardiotonic; Can make the expansion of tubular blood vessel and renal blood vessels, and make the expansion of whole body peripheral vessel, skin circulation is freely contained, and makes hyperpietic's blood pressure drops; The Radix Astragali also has medium diuresis, prevents the effect of nephritis and inhibition pathogenic bacteria.

The present invention provides a kind of preparation method of Chinese medicine composition of anti-hepatic fibrosis on the other hand, comprises the steps:

1) preparation Radix Astragali dry extract

At first: employing water or mass percent concentration are that the alcoholic solution of 10-60% is to extract solvent the Radix Astragali is carried out heating extraction 2-3 time, and then: merge also concentrated extracting solution, the extracting solution after will concentrating then carries out drying, gets Radix Astragali dry extract;

2) preparation Rhizoma Curcumae Longae dry extract

At first: the employing mass percent concentration is that the alcoholic solution of 20-80% is to extract solvent Rhizoma Curcumae Longae is carried out heating and refluxing extraction 2-3 time, and then: merge also concentrated extracting solution, the Rhizoma Curcumae Longae extracting solution after will concentrating then carries out drying, gets the Rhizoma Curcumae Longae dry extract;

3) preparation Radix Salviae Miltiorrhizae dry extract

At first adopting water or mass percent concentration is that the alcoholic solution of 20-50% carries out heating extraction 2-3 time for extracting solvent to Radix Salviae Miltiorrhizae, then merge and concentrated extracting solution, adding ethanol then in the Radix Salviae Miltiorrhizae extract after concentrating precipitates, filter, carry out drying after last filtrate concentrates, get Radix Salviae Miltiorrhizae dry extract;

4) preparation Chinese medicine composition

The Radix Astragali, Rhizoma Curcumae Longae and Radix Salviae Miltiorrhizae dry extract are mixed, pulverize the back and add Fel Ursi powder, mix homogeneously makes pharmaceutical composition of the present invention.

Wherein, adopt the volume that extracts solvent (water or mass percent concentration are the alcoholic solution of 10-60%) and the ratio of the weight of the Radix Astragali when carrying out described heating extraction in the step 1) is 8-10 at every turn: 1, extraction time is 1-3 hour/time, is preferably 1-2.5 hour/time;

Particularly, adopting mass percent concentration is the alcoholic solution heating and refluxing extraction Radix Astragali of 10-60%;

Particularly, Radix Astragali extractive solution is-0.07 at relative pressure～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.07～-0.095MPa), temperature be carry out under 50-70 ℃ the condition described concentrated; The volume of Radix Astragali extractive solution is 0.5-1.5 with the ratio of the weight of Milkvetch Root after concentrating: 1, be preferably 1: 1, and promptly the weight of Milkvetch Root is 1 with the ratio of the volume that concentrates the back Radix Astragali extractive solution: 0.5-1.5;

Particularly, the exsiccant temperature of described Radix Astragali concentrated extracting solution is 40-60 ℃, relative pressure is-0.07～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure when control is dry with respect to an atmospheric pressure be-0.07～-0.095MPa); The moisture content of Radix Astragali dry extract is 0.5-2%.

The volume of the extraction solvent that is adopted when at every turn carrying out described heating and refluxing extraction wherein, step 2) is 10-12 with the ratio of the weight of Rhizoma Curcumae Longae: 1, and extraction time is 0.5-3 hour/time;

Particularly, the Rhizoma Curcumae Longae extracting solution is-0.07 at relative pressure～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure when control concentrates with respect to an atmospheric pressure be-0.07～-0.095MPa), temperature be carry out under 40-60 ℃ the condition described concentrated; The volume of Rhizoma Curcumae Longae extracting solution is 0.5-1.5 with the ratio of the weight of Rhizoma Curcumae Longae medical material after concentrating: 1, be preferably 1: 1, and promptly the weight of Rhizoma Curcumae Longae medical material is 1 with the ratio of the volume that concentrates back Rhizoma Curcumae Longae extracting solution: 0.5-1.5;

Particularly, the baking temperature of described Rhizoma Curcumae Longae concentrated extracting solution is 40-60 ℃, relative pressure is-0.07～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.07～-0.095MPa); The moisture content of Rhizoma Curcumae Longae dry extract is 0.3-1%.

Wherein, the volume of the extraction solvent that is adopted when at every turn carrying out described heating extraction in the step 3) is 8-10 with the ratio of the weight of Radix Salviae Miltiorrhizae: 1, and extraction time is 1-3 hour/time;

Particularly, adopting mass percent concentration is the alcoholic solution heating and refluxing extraction Radix Salviae Miltiorrhizae of 20-50%;

Particularly, Radix Salviae Miltiorrhizae extract is-0.07 at relative pressure～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure when control concentrates with respect to an atmospheric pressure be-0.07～-0.095MPa), temperature be carry out under 50-70 ℃ the condition described concentrated; The volume of the Radix Salviae Miltiorrhizae extract after concentrating is 0.5-1.5 with the ratio of the weight of red rooted salvia: 1, be preferably 0.6-1: 1;

Particularly, add ethanol in the Radix Salviae Miltiorrhizae extract after concentrating, make that alcoholic acid mass percentage content is 40-80% in the Radix Salviae Miltiorrhizae extract after concentrating, leave standstill then, carry out described precipitation, sedimentation time 〉=12 hour;

Especially, to select dehydrated alcohol, mass percent concentration for use with ethanol be the ethanol of 70-95 for described precipitation;

Particularly, filtrate is-0.07 at relative pressure～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure when control concentrates with respect to an atmospheric pressure be-0.07～-0.095MPa), temperature be carry out under 50-70 ℃ the condition described concentrated; The volume of the Radix Salviae Miltiorrhizae filtrate after concentrating is 0.3-1.5 with the ratio of the weight of red rooted salvia: 1, be preferably 0.3-1: 1; Described baking temperature is 50-70 ℃, relative pressure is-0.07～-0.095MPa (be 0 promptly with an atmospheric pressure, the pressure when control is dry with respect to an atmospheric pressure be-0.07～-0.095MPa); The moisture content of Radix Salviae Miltiorrhizae dry extract is 0.1-1%.

Another aspect of the invention provides a kind of pharmaceutical preparation that prevents and/or treats hepatic fibrosis of being made by acceptable auxiliary combination on above-mentioned arbitrary described Chinese medicine composition and the pharmaceutics.

Wherein, pharmaceutical composition of the present invention can be pressed tradition or the oral type of the clinical acceptable of modern production manufacturing process with acceptable auxiliary on the pharmaceutics.As capsule, tablet, granule,, pill, oral liquid etc.Used excipient substance can be starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose, magnesium stearate etc.Need long-term prescription clinically, make solid preparation and store conveniently, the patient takes facility, also meeting the market requirement more.Preferred dosage form is capsule, granule, tablet.

Further aspect of the present invention provides a kind of above-mentioned arbitrary described Chinese medicine compositions to treat and/or prevent the application of the medicine of hepatic fibrosis in preparation.

Drug regimen of the present invention is for having following advantage:

1, medicament composing prescription compatibility science of the present invention, determined curative effect, safe, quality controllable;

2, pharmaceutical composition of the present invention have blood circulation promoting and blood stasis dispelling, set upright QI invigorating, the effect of heat-clearing and toxic substances removing, have excellent effect of anti hepatic fibrosis, can effectively delay the hepatic fibrosis process;

3, pharmaceutical composition action pathway of the present invention is many, and drug target is many, the mechanism of action uniqueness, and medicine is at crucial pathology link, medicine anti-hepatic fibrosis evident in efficacy.

4, medicine dosage of the present invention is low, with low cost.

The specific embodiment

Below further set forth the beneficial effect of medicine of the present invention by testing example, these test the routine pharmacodynamics test that has comprised medicine of the present invention.

Test example 1 medicine of the present invention causes the mass action of rat liver fibrosis to carbon tetrachloride

Test material:

Medicine capsule of the present invention, 0.5g/ grain (every contains crude drug 10g); FUFANG BIEJIA RUANGAN PIAN, lot number 20070516, NeiMenggu FuRuiZhong MengYao Science Co., Ltd produces.

Test method:

Get 62 of cleaning level male SD rats, body weight 150-200g, complete male, get 10 as normal control group (not modeling), all the other 52 are adopted carbon tetrachloride to prepare the rat liver fibrosis model: (be dissolved in the vegetable oil with the analytical pure carbon tetrachloride with 15% carbon tetrachloride solution, be made into the 150ml/L solution for standby) 1ml/100g body weight filling stomach, 2 times/week, continuous 7 weeks.Put to death 2 rats after 7 weeks of modeling at random, get liver and do histopathologic examination, confirm to have caused Liver Fibrosis Model.The rat of modeling success is divided into 5 groups at random, and promptly model group, positive drug group, administration high dose group, middle dosage group, low dose group stop modeling and begin gastric infusion.

The high, medium and low dosage group of administration is irritated stomach respectively and is given medicinal liquid of the present invention, and once a day, the administration high dose group is irritated stomach and given capsule 12g crude drug/kg of the present invention; The dosage group is irritated stomach and is given capsule 6g crude drug/kg of the present invention in the administration; The administration low dose group is irritated stomach and is given capsule 3g crude drug/kg of the present invention; The positive drug group is then irritated stomach and is given FUFANG BIEJIA RUANGAN PIAN 0.55g/kg, normal group and model group are all irritated stomach and are given isometric distilled water, all rat oral gavage volumes are 10ml/kg, continuous 8 weeks of gastric infusion, observe the animal ordinary circumstance every day, take a blood sample next day on an empty stomach after the last administration, and separation of serum detects AST, ALT index (testing result part table 1) in the serum with automatic clinical chemistry analyzer; Detect hepatic fibrosis index HA, PIIINP (testing result part table 2) in the serum to put the method for exempting from; The blood sampling back is put to death animal and is got liver, carry out histopathologic examination: take out liver organization, specimen is fixed through conventional 10% formalin solution, paraffin section, H-E dyeing, the pathological change situation of liver tissues of rats is respectively organized in observation under the light microscopic, and adopts Masson dyeing to observe fibrosis in the hepatic tissue.

Normal rats liver color is dark red, smooth surface, and clear-cut margin, quality is softer.The enlargement of model group rat liver, the edge is blunt, and quality is hard, and color is more shallow, but the edge is fair, and whole liver and peripheral organs adhesion are extensive.Each administration group rat liver form and normal group are approaching, significantly better than model group.

The influence of hepatic fibrosis rats liver function and hydroxyproline content due to the table 1 pair carbon tetrachloride (X ± S)

Annotate: compare with model group, ^*P＜0.05, ^*P＜0.01

The explanation of table 1 testing result:

1, by carbon tetrachloride the liver function of inductive Liver Fibrosis Model rat obvious damage is arranged, AST, ALT water mean pole are higher than normal control group (P＜0.01) significantly in the model group rat blood serum.Rats'liver function after the Drug therapy of the present invention then has obvious recovery, and AST, ALT level are compared with model group in its height, the middle dosage group rat blood serum all remarkable reduction (P＜0.05～0.01).Result of the test explanation, Chinese medicine composition of the present invention to carbon tetrachloride the liver function of inductive Liver Fibrosis Model rat improve significantly.

2, hydroxyproline content is significantly higher than normal group (P＜0.01) in the model group liver tissues of rats, and hydroxyproline content is compared with model group in the hepatic tissue of medicine height of the present invention, middle dosage group rat then significant reduction (P＜0.01).Show that pharmaceutical composition of the present invention has tangible reduction effect for the hydroxyproline content that increases unusually in the hepatic fibrosis rats hepatic tissue.

The influence of hepatic fibrosis index in the Liver Fibrosis Model rat blood serum due to the table 2 pair carbon tetrachloride (X ± S)

Annotate: compare with model group, ^*P＜0.05, ^*P＜0.01

By table 2 result as seen, HA, PIIINP level all are significantly higher than normal rat (P＜0.01) in the Liver Fibrosis Model rat blood serum, and height of the present invention, middle dosage all can obviously reduce HA and the PIIINP level (P＜0.05～0.01) in the serum.Experimental result shows, we all have some improvement to relevant hepatic fibrosis index in the hepatic fibrosis rats serum due to the carbon tetrachloride.

The result of histopathologic examination shows, the rats in normal control group hepatic tissue there is no tangible pathological change, and the lobules of liver structure exists, liver plate marshalling, indivedual routine structures are disorderly slightly, with the central vein is center radial arrangement towards periphery, the hepatocyte polygon, and slurry is abundant, nuclear is justified greatly, rare double-core, Masson dyeing see that hepatic tissue is interior except that seeing the annular collagen fiber around central vein and the little bile duct, and collagen fiber are not seen at all the other places.And 9 routine pathological changes highly significants are arranged in 10 rats of model group, the hepatic tissue leaflet structure is destroyed, as seen a large amount of proliferations of fibrous tissue, interspersed are divided into the circular or oval pseudolobuli that differs in size with hepatic tissue, and Masson dyeing shows proliferations of fibrous tissue in a large number in the hepatic tissue.Positive drug administration group pathological changes situation has necessarily than model group and alleviates, and indivedual examples are similar substantially to normal group, and it is similar that all the other each examples and model group change, but interior fibrosis of hepatic tissue and hepatic cell fattydegeneration all are clearly better than model group.Drug regimen object height of the present invention, middle each example of dosage group are compared with model group, and fibrosis all obviously alleviates in the hepatic tissue, and hepatic tissue changes similar substantially to normal group.

Histopathologic examination shows: rat liver fibrosis model modeling success, visible a large amount of outgrowth collagen fiber are net distribution in the model group liver tissues of rats.This high, medium and low dosage of writing out a prescription has significant improvement effect to the proliferation of fibrous tissue of hepatic fibrosis rats liver, illustrates that we have tangible effect of anti hepatic fibrosis.

Result of the test shows: Chinese medicine composition of the present invention for carbon tetrachloride the liver function of inductive hepatic fibrosis rats significant protective effect is arranged, can significantly reduce AST in the hepatic fibrosis rats serum, ALT level (P＜0.05～0.01), can significantly reduce hydroxyproline content in the hepatic fibrosis rats hepatic tissue (P＜0.01), and present dose dependent; Can significantly reduce unusual HA and the PIIINP level (P＜0.05～0.01) that raises in the hepatic fibrosis rats serum.The result of histopathologic examination shows that Chinese medicine composition of the present invention has significant improvement effect to the proliferation of fibrous tissue of hepatic fibrosis rats liver, illustrates that Chinese medicine of the present invention has the obvious treatment fibrosis effect.

Test example 2 chmice acute hepatic injury test

Experimental technique: 60 of cleaning level KM mices, body weight 18-20g, male and female half and half are divided into 6 groups at random, i.e. the high, medium and low dosage group of normal control group, model group, positive drug group and administration.Normal and model group is all irritated stomach and is given isometric distilled water, and high, medium and low dosage group is irritated stomach respectively, and to give drug regimen of the present invention be 24g crude drug/kg, 12g crude drug/kg, and 6g crude drug/kg, the positive drug group is irritated stomach and is given FUFANG BIEJIA RUANGAN PIAN 1.1g/kg.Every day gastric infusion once, continuous irrigation stomach 7 days.1h after the last administration, except that the normal control group, the equal lumbar injection D-Gal of all the other mices 800mg/kg causes the chmice acute liver injury model.24h takes a blood sample on an empty stomach after modeling, separation of serum, detect AST, ALT index in the serum with Hitachi's 7060 type automatic clinical chemistry analyzers, the blood sampling back is put to death animal and is got liver, the liver organization specimen is fixed through conventional 10% formalin solution, paraffin section, H-E dyeing, the pathological change situation of liver tissues of rats is respectively organized in observation under the light microscopic.Result of the test sees Table 3.

Table 3 compositions is to the influence of acute liver damage mice serum biochemical indicator due to the D-Gal (X ± S)

Annotate: compare with model group, ^*P＜0.05, ^*P＜0.01

By table 3 as seen, the lumbar injection D-Gal can cause the Mouse Liver function obviously to damage, and AST, ALT water mean pole are higher than normal control group (P＜0.01) significantly in the model group mice serum.The Mouse Liver function that gives the high, medium and low dosage of the present invention then has obvious recovery, and AST, ALT level are compared with model group all to have and extremely significantly reduced (P＜0.01) in its serum.

The result of mouse liver histopathologic examination shows: by the chmice acute liver dysfunction model modeling success that D-Gal caused, the model group mouse liver cell is coagulation necrosis and with a small amount of cell infiltration, liver tissue lesions is obvious, and this each administration group mouse liver lesion tissue degree of writing out a prescription all has clear improvement than model group, and is especially more remarkable with the high, medium and low dosage group of administration mice pathological changes improvement effect.

Medicine of the present invention.This results suggest we have tangible preventive and therapeutic effect to the caused chmice acute liver dysfunction of D-Gal.

The result of the test explanation: mice prevention administration gives medicine of the present invention, and cause the acute liver damage model through the lumbar injection D-Gal, unusual AST, the ALT level that raises all has extremely significant reduction effect (P＜0.01) in the acute hepatic function damage mice serum that medicine of the present invention is caused for the lumbar injection D-Gal, and the caused chmice acute liver dysfunction of lumbar injection D-Gal is had tangible preventive and therapeutic effect; The result of histopathologic examination shows that we's prevention administration has significant protective effect to the liver of the acute hepatic function damage mice that D-Gal caused; its liver organization pathological change has been compared significant improvement with model group, illustrate that medicine of the present invention has tangible hepatoprotective effect.

Experimental example 3 Chinese medicine compositions of the present invention are to the liver protection effect test of mice

Experimental technique: 60 of cleaning level KM mices, body weight 18-20g, male and female half and half are divided into 6 groups at random, i.e. normal control group, model group, positive drug group and high, medium and low dosed administration group.Normal and model group is all irritated stomach and is given isometric distilled water, and high, medium and low dosage group is irritated stomach respectively and given medicine 24g crude drug/kg of the present invention, 12g crude drug/kg, 6g crude drug/kg, and the positive drug group is irritated stomach and given FUFANG BIEJIA RUANGAN PIAN 1.1g/kg.Every day gastric infusion once, continuous irrigation stomach 7 days.1h after the last administration, except that the normal control group, the equal lumbar injection 0.1% carbon tetrachloride 0.1ml/10g of all the other mices causes the chmice acute liver injury model.16h takes a blood sample on an empty stomach after modeling, separation of serum, detect AST, ALT index in the serum with Hitachi's 7060 type automatic clinical chemistry analyzers, the blood sampling back is put to death animal and is got liver, the liver organization specimen is fixed through conventional 10% formalin solution, paraffin section, H-E dyeing, the pathological change situation of liver tissues of rats is respectively organized in observation under the light microscopic.Result of the test sees Table 4.

The variation of 1 blood parameters

Table 4 compositions is to the influence of acute liver damage mice serum biochemical indicator due to the carbon tetrachloride (X ± S)

Annotate: compare with model group, ^*P＜0.05, ^*P＜0.01.

By table 4 as seen, the lumbar injection carbon tetrachloride can cause the Mouse Liver function obviously to damage, and AST, ALT water mean pole are higher than normal control group (P＜0.01) significantly in the model group mice serum.The Mouse Liver function that gives height of the present invention, middle dose drug then has clear improvement than model group, and AST, ALT level are compared with model group all to have and extremely significantly reduced (P＜0.01) in its serum.

By the result of histopathologic examination as can be known: model group mouse liver cell edema, degeneration by the chmice acute liver dysfunction that carbon tetrachloride caused are obvious, and high, medium and low dosed administration group mouse liver lesion tissue degree of the present invention all has clear improvement than model group, and is especially more remarkable with administration height, middle dosage group mice pathological changes improvement effect.

Experimental result shows: mice prevention administration gives pharmaceutical composition of the present invention after the lumbar injection carbon tetrachloride causes the acute liver damage model, unusual AST, the ALT level that raises all has extremely significant reduction effect (P＜0.01) in the acute hepatic function damage mice serum that height of the present invention, middle dosed administration group are caused for the lumbar injection carbon tetrachloride, illustrates that medicine of the present invention has tangible preventive and therapeutic effect to the caused chmice acute liver dysfunction of lumbar injection carbon tetrachloride; Reason histological examination result shows that chemoprophylaxis administration of the present invention has significant protection and preventive effect to the liver of the acute hepatic function damage mice that carbon tetrachloride caused; its liver organization pathological change has been compared significant improvement with model group, illustrate that we have tangible hepatoprotective effect.

Fel Ursi powder is provided by Fujian Guizhentang Drug Industry Co., Ltd in the embodiment of the invention; Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, the Radix Astragali are available from Nanjing medicine company limited.

The capsule preparation of embodiment 1 medicine of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 1, Radix Salviae Miltiorrhizae 20, Rhizoma Curcumae Longae 40, the Radix Astragali 60

2, preparation Radix Astragali dry extract

2-1) Radix Astragali is added to the water, heating decocts extracts, extract altogether 2 times, merge twice Radix Astragali extractive solution, wherein, the volume of the water that adds when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, be that the 1kg Radix Astragali adds 10L water, the volume of the water that adds when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L water, and extraction time is 2h/ time;

2-2) Radix Astragali extractive solution is carried out concentrating under reduced pressure, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 60L, be equivalent to contain in the every milliliter of Radix Astragali concentrated extracting solution 1.0g Radix Astragali crude drug, or contain 1kg Radix Astragali crude drug in every liter of Radix Astragali concentrated extracting solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 1: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.09MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 50 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.07MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.07MPa), the moisture content of Radix Astragali dry extract is 2%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether in 80% the ethanol, merge three times Rhizoma Curcumae Longae extracting solution, wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Alcoholic acid volume is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae when extracting for the third time, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 3h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 40L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 1.0g Rhizoma Curcumae Longae crude drug, or contain 1kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, promptly the weight of crude drug Rhizoma Curcumae Longae is 1: 1 with the ratio of the volume of Rhizoma Curcumae Longae concentrated extracting solution; Carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 60 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), the moisture content of Rhizoma Curcumae Longae dry extract is 1%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae is added to the water, heating extraction is extracted 3 times altogether, merges three times Radix Salviae Miltiorrhizae extract, and wherein, the volume of the water when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, and promptly the 1kg Radix Salviae Miltiorrhizae adds 10L water; The volume of water is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; The volume of water is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the third time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; Extraction time is 1h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 15.4L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.3g Radix Salviae Miltiorrhizae crude drug, or contain 1.3kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.3: 1, then add dehydrated alcohol and make that alcoholic acid mass percent concentration is 80% in the Radix Salviae Miltiorrhizae concentrated extracting solution, stir evenly, placed 12 hours, precipitation, filter, filtrate is carried out concentrating under reduced pressure, obtains the Radix Salviae Miltiorrhizae concentrated solution, wherein, relative pressure during concentrating under reduced pressure for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 60 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 20L, is equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated solution 1g Radix Salviae Miltiorrhizae crude drug, contains 1kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 1: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 50 ℃, relative pressure when dry for-(with an atmospheric pressure is 0 to 0.09MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), the moisture content of Radix Salviae Miltiorrhizae dry extract is 0.5%;

5, preparation capsule

Radix Astragali dry extract, Rhizoma Curcumae Longae dry extract and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 80 purpose powder, and mix homogeneously makes the medicament mixed powder;

With after adjuvant cane sugar powder, magnesium stearate are mixed, pack the medicament mixed powder into snap fit capsule promptly.

The granule preparation of embodiment 2 medicines of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 2, Radix Salviae Miltiorrhizae 10, Rhizoma Curcumae Longae 30, the Radix Astragali 60

2, preparation Radix Astragali dry extract

2-1) Radix Astragali being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether in 10% the ethanol, merge three times extracting solution, wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 10L ethanol; Alcoholic acid volume when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of the Radix Astragali when extracting for the third time, and promptly the 1kg Radix Astragali adds 8L ethanol; Extraction time is 1.5h/ time;

2-2) extracting solution is concentrated, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 75L, be equivalent to contain in every milliliter of concentrated extracting solution 0.8g Radix Astragali crude drug, or contain 0.8kg Radix Astragali crude drug in every liter of Radix Astragali concentrated solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 0.8: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.07MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.07MPa), thickening temperature is 70 ℃; The vacuum drying temperature is 40 ℃, the relative pressure when dry for-0.09MPa (with an atmospheric pressure is 0, the pressure when control is dry with respect to an atmospheric pressure be-0.09MPa), the moisture content of Radix Astragali dry extract is 2%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 2 times altogether, merges 2 times extracting solution in 70% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 2.5h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 22L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 1.4g Rhizoma Curcumae Longae crude drug, or contain 1.4kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, promptly the weight of crude drug Rhizoma Curcumae Longae is 1.4: 1 with the ratio of the volume of Rhizoma Curcumae Longae concentrated extracting solution; Carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure for-0.07MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.07MPa); Thickening temperature is 50 ℃; The vacuum drying temperature is 50 ℃, and the relative pressure when dry is-0.095MPa that the moisture content of Rhizoma Curcumae Longae dry extract is 0.5%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae is added to the water, heating extraction is extracted 3 times altogether, merges three times extracting solution, and wherein, the volume of the water when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, and promptly the 1kg Radix Salviae Miltiorrhizae adds 10L water; The volume of water is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; The volume of water is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the third time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; Extraction time is 1.5h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 10L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.0g Radix Salviae Miltiorrhizae crude drug, or contain 1.0kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.0: 1, then add dehydrated alcohol and make that alcoholic acid mass percent concentration is 40% in the Radix Salviae Miltiorrhizae concentrated extracting solution, stir evenly, placed 12 hours, precipitation, filter, filtrate is carried out concentrating under reduced pressure, obtains the Radix Salviae Miltiorrhizae concentrated solution, wherein, relative pressure during concentrating under reduced pressure for-0.07MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.07MPa), thickening temperature is 70 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 5L, is equivalent to contain 2g Radix Salviae Miltiorrhizae crude drug in every milliliter of Radix Salviae Miltiorrhizae concentrated solution, or contains 2kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 2: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 70 ℃, relative pressure when dry for-(with an atmospheric pressure is 0 to 0.07MPa, the pressure of control during vacuum drying with respect to an atmospheric pressure be-0.07MPa), the moisture content of Radix Salviae Miltiorrhizae dry extract is 0.8%;

5, preparation granule

Radix Astragali dry extract, Rhizoma Curcumae Longae dry extract and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 60 purpose powder, and mix homogeneously makes the medicament mixed powder;

The medicament mixed powder with after the adjuvant dextrin mixes, is pressed into granule.

The preparation tablets of embodiment 3 medicines of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 1.5, Radix Salviae Miltiorrhizae 20, Rhizoma Curcumae Longae 30, the Radix Astragali 50

2, preparation Radix Astragali dry extract

2-1) Radix Astragali being joined mass percent concentration is that heating and refluxing extraction is extracted 2 times altogether, merges 2 times extracting solution in 30% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 10L ethanol; Alcoholic acid volume when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Extraction time is 2.5h/ time;

2-2) Radix Astragali extractive solution is concentrated, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 41.7L, be equivalent to contain in the every milliliter of Radix Astragali concentrated extracting solution 1.2g Radix Astragali crude drug, or contain 1.2kg Radix Astragali crude drug in every liter of Radix Astragali concentrated extracting solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 1.2: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.08MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.08MPa), thickening temperature is 60 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.08MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.08MPa), the moisture content of Radix Astragali dry extract is 1%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 2 times altogether, merges 2 times extracting solution in 60% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 2.0h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 24L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 1.25g Rhizoma Curcumae Longae crude drug, or contain 1.25kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, promptly the weight of crude drug Rhizoma Curcumae Longae is 1.25: 1 with the ratio of the volume of Rhizoma Curcumae Longae concentrated extracting solution; Carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure for-0.08MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.08MPa), thickening temperature is 50 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.08MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.08MPa), the moisture content of Rhizoma Curcumae Longae dry extract is 0.5%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae being joined mass percent concentration is that heating extraction is extracted 2 times altogether, merges 2 times extracting solution in 20% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, and promptly the 1kg Radix Salviae Miltiorrhizae adds 10L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L ethanol; Extraction time is 3.0h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 13.3L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.5g Radix Salviae Miltiorrhizae crude drug, or contain 1.5kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.5: 1, then add dehydrated alcohol and make that alcoholic acid mass percentage content is 60% in the Radix Salviae Miltiorrhizae concentrated extracting solution, stir evenly, placed 12 hours, precipitation, filter, filtrate is carried out concentrating under reduced pressure, obtains the Radix Salviae Miltiorrhizae concentrated solution, wherein, relative pressure during concentrating under reduced pressure for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 50 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 20L, is equivalent to contain 1g Radix Salviae Miltiorrhizae crude drug in every milliliter of Radix Salviae Miltiorrhizae concentrated solution, or contains 1kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 1: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 60 ℃, relative pressure when dry for-(with an atmospheric pressure is 0 to 0.08MPa, the pressure of control during vacuum drying with respect to an atmospheric pressure be-0.08MPa), the moisture content of Radix Salviae Miltiorrhizae dry extract is 0.6%;

5, preparation tablet

Radix Astragali dry extract, Rhizoma Curcumae Longae dry extract and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 100 purpose powder, and mix homogeneously makes the medicament mixed powder;

The medicament mixed powder with after supplementary product starch mixes, is pressed into tablet.

The pill preparation of embodiment 4 medicines of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 1, Radix Salviae Miltiorrhizae 20, Rhizoma Curcumae Longae 40, the Radix Astragali 80

2, preparation Radix Astragali dry extract

2-1) Radix Astragali being joined mass percent concentration is that heating and refluxing extraction is extracted 2 times altogether, merges 2 times extracting solution in 40% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 10L ethanol; Alcoholic acid volume when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Extraction time is 1.0h/ time;

2-2) Radix Astragali extractive solution is concentrated, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 88.9L, be equivalent to contain in the every milliliter of Radix Astragali concentrated extracting solution 0.9g Radix Astragali crude drug, or contain 0.9kg Radix Astragali crude drug in every liter of Radix Astragali concentrated extracting solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 0.9: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.095MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.095MPa), thickening temperature is 50 ℃; The vacuum drying temperature is 60 ℃, and the relative pressure when dry is-0.09MPa that the moisture content of Radix Astragali dry extract is 1%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether, merges 3 times extracting solution in 60% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Alcoholic acid volume when extracting for the third time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 1.0h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 40L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 1g Rhizoma Curcumae Longae crude drug, or contain 1kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, promptly the weight of crude drug Rhizoma Curcumae Longae is 1: 1 with the ratio of the volume of Rhizoma Curcumae Longae concentrated extracting solution; Carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure is-0.09MPa that thickening temperature is 60 ℃; The vacuum drying temperature is 40 ℃, and the relative pressure when dry is-0.095MPa that the moisture content of Rhizoma Curcumae Longae dry extract is 0.3%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae being joined mass percent concentration is that heating extraction is extracted 3 times altogether, merges 3 times extracting solution in 30% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, and promptly the 1kg Radix Salviae Miltiorrhizae adds 10L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the third time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; Extraction time is 1.0h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 15.4L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.3g Radix Salviae Miltiorrhizae crude drug, or contain 1.3kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.3: 1, then add dehydrated alcohol and make that alcoholic acid mass percentage content is 70% in the Radix Salviae Miltiorrhizae concentrated extracting solution, stir evenly, placed 12 hours, precipitation, filter, filtrate is carried out concentrating under reduced pressure, obtains the Radix Salviae Miltiorrhizae concentrated solution, wherein, relative pressure during concentrating under reduced pressure for-0.095MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.095MPa), thickening temperature is 60 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 20L, is equivalent to contain 1g Radix Salviae Miltiorrhizae crude drug in every milliliter of Radix Salviae Miltiorrhizae concentrated solution, or contains 1kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 1: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 60 ℃, relative pressure when dry is-0.095MPa, (be 0 promptly with an atmospheric pressure, the pressure of control during vacuum drying with respect to an atmospheric pressure for-0.095MPa) moisture content of Radix Salviae Miltiorrhizae dry extract is 0.3%;

5, preparation pill

The Radix Astragali, Rhizoma Curcumae Longae and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 100 purpose powder, and mix homogeneously makes mixed-powder;

Mixed-powder and adjuvant are joined in the pellet processing machine, make pill.

The capsule preparation of embodiment 5 medicines of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 3, Radix Salviae Miltiorrhizae 30, Rhizoma Curcumae Longae 60, the Radix Astragali 30

2, preparation Radix Astragali dry extract

2-1) Radix Astragali being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether, merges 3 times extracting solution in 50% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 10L ethanol; Alcoholic acid volume when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Alcoholic acid volume when extracting for the third time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Extraction time is 1.5h/ time;

2-2) Radix Astragali extractive solution is concentrated, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 25L, be equivalent to contain in the every milliliter of Radix Astragali concentrated extracting solution 1.2g Radix Astragali crude drug, or contain 1.2kg Radix Astragali crude drug in every liter of Radix Astragali concentrated extracting solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 1.2: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.08MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.08MPa), thickening temperature is 60 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.09MPa), the moisture content of Radix Astragali dry extract is 1%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether in 50% the ethanol, merge extracting solution, wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Alcoholic acid volume when extracting for the third time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 2.0h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 30L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 2g Rhizoma Curcumae Longae crude drug, or contain 2kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, promptly the weight of crude drug Rhizoma Curcumae Longae is 2: 1 with the ratio of the volume of Rhizoma Curcumae Longae concentrated extracting solution; Carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 60 ℃; The vacuum drying temperature is 40 ℃, the relative pressure when dry for-0.095MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.095MPa), the moisture content of Rhizoma Curcumae Longae dry extract is 0.5%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae being joined mass percent concentration is that heating extraction is extracted 2 times altogether in 40% the ethanol, merge extracting solution, wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, promptly the 1kg Radix Salviae Miltiorrhizae adds 10L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L ethanol; Extraction time is 1.0h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 23.1L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.3g Radix Salviae Miltiorrhizae crude drug, or contain 1.3kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.3: 1, then adds dehydrated alcohol, makes that alcoholic acid mass percentage content is 50% in the Radix Salviae Miltiorrhizae concentrated extracting solution, stir evenly, placed 12 hours, precipitation is filtered, filtrate is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated solution, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.08MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.08MPa), thickening temperature is 60 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 10L, is equivalent to contain 3g Radix Salviae Miltiorrhizae crude drug in every milliliter of Radix Salviae Miltiorrhizae concentrated solution, or contains 3kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 3: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 50 ℃, relative pressure when dry for-(with an atmospheric pressure is 0 to 0.095MPa, the pressure of control during vacuum drying with respect to an atmospheric pressure be-0.095MPa), the moisture content of Radix Salviae Miltiorrhizae dry extract is 0.1%;

5, preparation capsule

Radix Astragali dry extract, Rhizoma Curcumae Longae dry extract and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 80-100 purpose powder, and mix homogeneously makes the medicament mixed powder;

With after supplementary product starch mixes, the snap fit capsule of packing into is made capsule with the medicament mixed powder.

The capsule preparation of embodiment 6 medicines of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 5, Radix Salviae Miltiorrhizae 50, Rhizoma Curcumae Longae 20, the Radix Astragali 80

2, preparation Radix Astragali dry extract

2-1) Radix Astragali being joined mass percent concentration is that heating and refluxing extraction is extracted 2 times altogether, merges 2 times extracting solution in 60% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 10L ethanol; Alcoholic acid volume when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Extraction time is 1.5h/ time;

2-2) Radix Astragali extractive solution is concentrated, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 53.3L, be equivalent to contain in the every milliliter of Radix Astragali concentrated extracting solution 1.5g Radix Astragali crude drug, or contain 1.5kg Radix Astragali crude drug in every liter of Radix Astragali concentrated extracting solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 1.5: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.09MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 50 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.095MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.095MPa), the moisture content of Radix Astragali dry extract is 0.5%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 2 times altogether, merges 2 times extracting solution in 30% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 1.0h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 22.2L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 0.9g Rhizoma Curcumae Longae crude drug, or contain 0.9kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, promptly the weight of crude drug Rhizoma Curcumae Longae is 0.9: 1 with the ratio of the volume of Rhizoma Curcumae Longae concentrated extracting solution; Carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure for-0.08MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.08MPa), thickening temperature is 60 ℃; The vacuum drying temperature is 50 ℃, and the relative pressure when dry is-0.08MPa that the moisture content of Rhizoma Curcumae Longae dry extract is 0.8%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae being joined mass percent concentration is that heating extraction is extracted 3 times altogether, merges 3 times extracting solution in 50% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, and promptly the 1kg Radix Salviae Miltiorrhizae adds 10L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L ethanol; Alcoholic acid volume is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the third time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; Extraction time is 1.5h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 38.5L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.3g Radix Salviae Miltiorrhizae crude drug, or contain 1.3kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.3: 1, then add dehydrated alcohol and make that alcoholic acid mass percentage content is 50% in the birth concentrated extracting solution, stir evenly, placed 12 hours, precipitation, filter, filtrate is carried out concentrating under reduced pressure, obtains the Radix Salviae Miltiorrhizae concentrated solution, wherein, relative pressure during concentrating under reduced pressure for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 60 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 50L, is equivalent to contain 1g Radix Salviae Miltiorrhizae crude drug in every milliliter of Radix Salviae Miltiorrhizae concentrated solution, or contains 1kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 1: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 70 ℃, relative pressure when dry for-(with an atmospheric pressure is 0 to 0.08MPa, the pressure of control during vacuum drying with respect to an atmospheric pressure be-0.08MPa), the moisture content of Radix Salviae Miltiorrhizae dry extract is 0.6%;

5, preparation capsule

Radix Astragali dry extract, Rhizoma Curcumae Longae dry extract and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 100 purpose powder, and mix homogeneously makes the medicament mixed powder;

With after the adjuvant microcrystalline cellulose mixes, the snap fit capsule of packing into is made capsule with the medicament mixed powder.

The granule preparation of embodiment 7 medicines of the present invention

1, prepare raw material (kg) according to following weight proportion:

Fel Ursi powder 10, Radix Salviae Miltiorrhizae 10, Rhizoma Curcumae Longae 100, the Radix Astragali 200

2, preparation Radix Astragali dry extract

2-1) Radix Astragali being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether, merges 3 times extracting solution in 40% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 10: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 10L ethanol; Alcoholic acid volume when extracting for the second time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Alcoholic acid volume when extracting for the third time is 8: 1 with the ratio of the weight of the Radix Astragali, and promptly the 1kg Radix Astragali adds 8L ethanol; Extraction time is 1.5h/ time;

2-2) Radix Astragali extractive solution is concentrated, obtain Radix Astragali concentrated extracting solution, wherein, the volume of Radix Astragali concentrated extracting solution is 200L, be equivalent to contain in the every milliliter of Radix Astragali concentrated extracting solution 1.0g Radix Astragali crude drug, or contain 1kg Radix Astragali crude drug in every liter of Radix Astragali concentrated extracting solution, the ratio that is weight and the volume of Radix Astragali concentrated extracting solution of the crude drug Radix Astragali is 1: 1, carry out vacuum drying then, make Radix Astragali dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.07MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.07MPa), thickening temperature is 60 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.09MPa), the moisture content of Radix Astragali dry extract is 1%;

3, preparation Rhizoma Curcumae Longae dry extract

3-1) Rhizoma Curcumae Longae being joined mass percent concentration is that heating and refluxing extraction is extracted 3 times altogether, merges 3 times extracting solution in 20% the ethanol, and wherein, the alcoholic acid volume when extracting for the first time is 12: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 12L ethanol; Alcoholic acid volume when extracting for the second time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Alcoholic acid volume when extracting for the third time is 10: 1 with the ratio of the weight of Rhizoma Curcumae Longae, and promptly the 1kg Rhizoma Curcumae Longae adds 10L ethanol; Extraction time is 1.0h/ time;

3-2) the Rhizoma Curcumae Longae extracting solution carries out concentrating under reduced pressure, obtain the Rhizoma Curcumae Longae concentrated extracting solution, wherein, the volume of Rhizoma Curcumae Longae concentrated extracting solution is 100L, be equivalent to contain in every milliliter of Rhizoma Curcumae Longae concentrated extracting solution 1g Rhizoma Curcumae Longae crude drug, or contain 1kg Rhizoma Curcumae Longae crude drug in every liter of Rhizoma Curcumae Longae concentrated extracting solution, the ratio that is weight and the volume of Rhizoma Curcumae Longae concentrated extracting solution of crude drug Rhizoma Curcumae Longae is 1: 1, carry out vacuum drying then, make the Rhizoma Curcumae Longae dry extract, wherein, the relative pressure during concentrating under reduced pressure for-(with an atmospheric pressure is 0 to 0.09MPa, the pressure of control during concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 50 ℃; The vacuum drying temperature is 50 ℃, the relative pressure when dry for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control vacuum drying with respect to an atmospheric pressure be-0.09MPa), the moisture content of Rhizoma Curcumae Longae dry extract is 0.6%;

4, preparation Radix Salviae Miltiorrhizae dry extract

4-1) Radix Salviae Miltiorrhizae is added to the water, heating extraction is extracted 3 times altogether, merges 3 times extracting solution, and wherein, the volume of the water when extracting for the first time is 10: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae, and promptly the 1kg Radix Salviae Miltiorrhizae adds 10L water; The volume of water is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the second time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; The volume of water is 8: 1 with the ratio of the weight of Radix Salviae Miltiorrhizae when extracting for the third time, and promptly the 1kg Radix Salviae Miltiorrhizae adds 8L water; Extraction time is 1.0h/ time;

4-2) Radix Salviae Miltiorrhizae extract is carried out concentrating under reduced pressure, obtain the Radix Salviae Miltiorrhizae concentrated extracting solution, wherein, the volume of Radix Salviae Miltiorrhizae concentrated extracting solution is 7.7L, be equivalent to contain in every milliliter of Radix Salviae Miltiorrhizae concentrated extracting solution 1.3g Radix Salviae Miltiorrhizae crude drug, or contain 1.3kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated extracting solution, the ratio that is weight and the volume of Radix Salviae Miltiorrhizae concentrated extracting solution of crude drug Radix Salviae Miltiorrhizae is 1.3: 1, then add dehydrated alcohol and make that alcoholic acid mass percentage content is 80% in the Radix Salviae Miltiorrhizae concentrated extracting solution, stir evenly, placed 12 hours, precipitation, filter, filtrate is carried out concentrating under reduced pressure, obtains the Radix Salviae Miltiorrhizae concentrated solution, wherein, relative pressure during concentrating under reduced pressure for-0.09MPa (with an atmospheric pressure is 0, the pressure during the control concentrating under reduced pressure with respect to an atmospheric pressure be-0.09MPa), thickening temperature is 60 ℃; The volume of Radix Salviae Miltiorrhizae concentrated solution is 10L, is equivalent to contain 1g Radix Salviae Miltiorrhizae crude drug in every milliliter of Radix Salviae Miltiorrhizae concentrated solution, or contains 1kg Radix Salviae Miltiorrhizae crude drug in every hydrargrum oxydatum crudum ginseng concentrated solution, and promptly the weight of crude drug Radix Salviae Miltiorrhizae is 1: 1 with the ratio of Radix Salviae Miltiorrhizae concentrated solution volume;

4-3) the Radix Salviae Miltiorrhizae concentrated solution is carried out vacuum drying, make Radix Salviae Miltiorrhizae dry extract, wherein the vacuum drying temperature is 60 ℃, relative pressure when dry for-(with an atmospheric pressure is 0 to 0.09MPa, the pressure of control during vacuum drying with respect to an atmospheric pressure be-0.09MPa), the moisture content of Radix Salviae Miltiorrhizae dry extract is 0.5%;

5, preparation granule

Radix Astragali dry extract, Rhizoma Curcumae Longae dry extract and Radix Salviae Miltiorrhizae dry extract are mixed, and being ground into granularity is to add Fel Ursi powder behind the 150 purpose powder, and mix homogeneously makes the medicament mixed powder;

The medicament mixed powder with after supplementary product starch, dextrin mix, is pressed into granule.

Claims (9)

1. anti-hepatic fibrosis Chinese medicine composition, it is characterized in that by following raw material: Fel Ursi powder, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, the Radix Astragali are made, and wherein, the weight portion proportioning of described raw material is: Fel Ursi powder 1-10, Radix Salviae Miltiorrhizae 10-50, Rhizoma Curcumae Longae 20-100, Radix Astragali 30-200.

2. Chinese medicine composition as claimed in claim 1 is characterized in that the weight portion proportioning of described raw material is selected: Fel Ursi powder 1-5, Radix Salviae Miltiorrhizae 10-30, Rhizoma Curcumae Longae 30-60, Radix Astragali 50-80.

3. Chinese medicine composition as claimed in claim 2 is characterized in that the weight portion proportioning of described raw material is chosen as: Fel Ursi powder 1, Radix Salviae Miltiorrhizae 20, Rhizoma Curcumae Longae 40, the Radix Astragali 60.

One kind as claim 1-3 arbitrary as described in the preparation method of anti-hepatic fibrosis Chinese medicine composition, comprise following step of carrying out:

1) preparation Radix Astragali dry extract

At first: employing water or mass percent concentration are that the alcoholic solution of 10-60% is to extract solvent the Radix Astragali is carried out heating extraction 2-3 time, then merge also concentrated extracting solution, and the extracting solution after will concentrating then carries out drying, gets Radix Astragali dry extract;

2) preparation Rhizoma Curcumae Longae dry extract

At first adopting mass percent concentration is that the alcoholic solution of 20-80% carries out heating and refluxing extraction 2-3 time for extracting solvent to Rhizoma Curcumae Longae, then merges and concentrated extracting solution, and the Rhizoma Curcumae Longae extracting solution after will concentrating then carries out drying, gets the Rhizoma Curcumae Longae dry extract;

3) preparation Radix Salviae Miltiorrhizae dry extract

At first adopting water or mass percent concentration is that the alcoholic solution of 20-50% carries out heating extraction 2-3 time for extracting solvent to Radix Salviae Miltiorrhizae, then merge and concentrated extracting solution, adding ethanol then in the Radix Salviae Miltiorrhizae extract after concentrating precipitates, filter, carry out drying after last filtrate concentrates, get Radix Salviae Miltiorrhizae dry extract;

4) preparation Chinese medicine composition

The Radix Astragali, Rhizoma Curcumae Longae and Radix Salviae Miltiorrhizae dry extract are mixed, pulverize the back and add Fel Ursi powder, mix homogeneously makes pharmaceutical composition of the present invention.

5. preparation method as claimed in claim 4 is characterized in that it is 8-10 that each described heating extraction in the step 1) adopts the volume that extracts solvent and the ratio of the weight of the Radix Astragali: 1, and extraction time is 1-3 hour/time.

6. as claim 4 or 5 described preparation methoies, it is characterized in that step 2) in the ratio of volume and the weight of Rhizoma Curcumae Longae of the extraction solvent that each described heating extraction adopted be 10-12: 1, extraction time is 0.5-3 hour/time.

7. as claim 4 or 5 described preparation methoies, the volume that it is characterized in that the extraction solvent that each described heating extraction adopted in the step 3) is 8-10 with the ratio of the weight of Radix Salviae Miltiorrhizae: 1, and extraction time is 1-3 hour/time.

8. as claim 4 or 5 described preparation methoies, the volume of Radix Astragali extractive solution is 0.5-1.5 with the ratio of the weight of Milkvetch Root after it is characterized in that concentrating in the step 1): 1; Step 2) volume of Rhizoma Curcumae Longae extracting solution is 0.5-1.5 with the ratio of the weight of Rhizoma Curcumae Longae medical material after concentrating in: 1; The volume of the Radix Salviae Miltiorrhizae extract after concentrating in the step 3) is 0.5-1.5 with the ratio of the weight of red rooted salvia: 1.

As claim 1 to 3 arbitrary as described in the Chinese medicine compositions treat and/or prevent the application of the medicine of hepatic fibrosis in preparation.