CN1772269A - Medicine composition for treating chronic hepatitis and its prepn - Google Patents

Abstract

The present invention discloses one kind of medicine composition for treating chronic hepatitis and its preparation process. The medicine composition contains active components prepared with ginseng, schisandra, red sage, angelica, curcuma root, white peony root, dried orange peel and licorice. The medicine composition may be dripping pill, granule, tablet, capsule or other common Chinese medicine preparation forms. The medicine composition has the functions of benefiting vital energy, promoting blood circulation, dispersing stagnated liver energy and nourishing liver and is used in treating chronic hepatitis.

Description

A kind of pharmaceutical composition for the treatment of chronic hepatitis and preparation method thereof

Technical field

The present invention relates to a kind of pharmaceutical composition for the treatment of chronic hepatitis and preparation method thereof, belong to tcm field.

Background technology

After chronic hepatitis B (abbreviation chb) is hepatitis b virus infection (HBV), continue for a long time or movable repeatedly a kind of chronic infectious disease based on the liver inflammatory reaction.According to statistics, the whole world infects HBV person and accounts for 5% of global population, and China is one " hepatopathy big country ", and China has 1.2 hundred million hepatitis B virus carrierss approximately, accounts for 1/2nd of the world.China's annual report hepatitis B new cases number is about 500,000, accounts for 1/4 of national first, Category B notifiable disease report morbidity total number of persons.According to investigations, at present the whole nation has and now suffers from chronic diseases about 2,000 ten thousand people of virus hepatitis patient, dies from about 280,000 people of the hepatopathy relevant with hepatitis B every year, and wherein 50% is primary hepatoma.Though after implementing the hepatitis B immune plan, the hepatitis B morbidity is necessarily controlled, but fall ill about 1,400,000 at present every year on average, occupy the 3rd of Notifiable disease, carry hepatitis B virus or its antigen China 1.2 hundred million people that have an appointment, about 20% can develop into chronic hepatitis in hepatitis B patient, and chronic viral hepatitis B is the main hazard factor of liver cirrhosis, hepatocarcinoma, liver failure.

Hepatitis B is popular serious to people ' s health harm, and overburden in social economy.The part hepatitis b virus carrier will develop into liver cirrhosis patient, and the small part chronic hepatitis patients also can change hepatocarcinoma into.Hepatitis B not only has a strong impact on health, and causes heavy financial burden for family, society, and China is used for medical treatment, the health subsidies of hepatitis and hepatopathy every year and uses up to more than 1,000 hundred million yuan.Hepatitis B also is a key factor of backing into poverty by medical crises, drive into poverty by medical crises in the poverty-stricken area.In addition, hepatitis b virus carrier start going to a nursery, aspect such as entrance, employment, marriage is subjected to very big influence.Therefore, control and treatment hepatitis B are very important.

At present, still imperfectly understand for the hepatitis B pathogeny, the caused hepatitis B of HBV, its pathogeny depends on virus and human immune system's results of interaction.Although HBV constantly duplicates in hepatocyte, itself does not directly damage hepatocyte, but causes the infringement of cell by host's immunoreation.Because host's immunologic function is not enough to remove intravital virus, so easily cause the slow virus carrier state.Its pathogeny: (1) body can not be removed HBV fully.Because body produces the defective of antibody abilities such as anti-HBs, simultaneously because its T cell function is low, cause unable removing virus, cause hepatocyte to continue to be infected.(2) immunocyte is to hepatocellular infiltration and destruction.When chronic hepatitis, the lymphocyte in the hepatocyte is based on the T cell, and cytotoxic T cell (Tc) can kill and wound the hepatocyte that infected by HBV.Because it is low that macrophage and T cell discharge interleukin II (IL-2), causes the Tc functional defect, can cause HBV to infect chronicity.External cell toxicity test proves, to hepatocellular ADCC cytotoxicity, acts on the liver cell membrane with antibodies, causes the necrosis and the inflammation in lobules of liver district, forms piecemeal necrosis.(3) immunity of organism regulatory function imbalance, mainly show as the change of SC hypofunction and immunoregulatory factor, can form chronic inflammatory disease, the structure disturbance or the destruction of liver biopsy lobules of liver, there is the bridge senile appearance dead between the portal vein district or between central vein and the portal vein, extensive necrosis is also arranged in the lobules of liver, form chronic active hepatitis.

Modern medicine can effectively adopt Hepatitis B virus vaccine to prevent to the prevention of primary disease both at home and abroad at present, but clinical treatment does not have specific short so far.Western medical treatment is noted the nutrition except that suitable rest, available hepatic, or hepatovirus medicine, and treatments such as immunomodulator, curative effect is all satisfied inadequately.With the passing of time state of an illness delay often is converted into chronic hepatitis, and can change hepatitis interstitialis chronica late period into, even forms hepatocarcinoma.The existing common drug interferon-ALPHA of doctor trained in Western medicine, lamivudine, thymosin, other medicines have silymarin (Legalon), sulphuric acid Luo Ning (tiopronin tablets), the sweet peptide of paddy gastral cavity, promoting growth of cell element etc., but its curative effect is limited.

The traditional Chinese medical science does not have the hepatitis B name of disease ancient times.The means of modern diagnosis primary disease are mainly by etiological examination, many patient's non-evident symptons and sign.Primary disease belongs to categories such as the traditional Chinese medical science " hypochondriac pain ", " jaundice ", " lump in the abdomen ".Primary disease takes place, and liver spleen body constitution or insufficiency of the spleen latency of plain body are often arranged.Exopathogen epidemic disease caused by damp-heat pathogen poison is invaded excessive liver and gall, because insufficiency of the spleen and insufficiency of primordial QI, liver spleen and catharsis is not normal can not be arranged heresy to go out, so that the epidemic disease caused by damp-heat pathogen poison is detained in the body.Damp and hot heresy is touching, and with the passing of time healthy energy damage by the real void that causes, forms stagnation of liver-QI with deficiency of the spleen, the resistance of the liver blood stasis of blood, or blood stasis due to qi deficiency and cause primary disease and show effect repeatedly, and Ke Zhi mass in the abdomen, tympanites, even jaundice, hemorrhage, coma.The method of effecting a permanent cure is mainly protecting liver and expelling toxin, replenishing QI to invigorate the spleen, easing the affected liver nourishing the liver, methods such as nourishing blood and promoting blood circulation.Chinese medicine and Chinese patent medicine extensively are used to treat primary disease at home, and the Chinese patent medicine of the treatment hepatitis B of using on the existing market has following a few class: (1) the liver benefiting spleen invigorating, tonify deficiency is set upright class: as lentinan film, Yiganling tablet, krestin capsule, Chaoyang pellet etc.(2) liver heat removing function of gallbladder promoting, detoxifcation removing blood stasis class: as hepatitis B heat-clearing and toxic substances removing granule, mattress stilbene GANFU KELI, hepatitis B detoxifying capsule, the MIEAOLING sheet, Liver-Restoring Tablet is protected proheparinum tablet etc.(3) nourishing the liver and kidney, the nourshing blood and promoting blood circulation class: as the chronic hepatitis yin-nourishing capsule, liver reaches sheet etc.(4) liver-smoothing, qi-regulating, disperse blood stasis and dredge collateral: reach recovering capsule as liver, liver-protecting tablet, Herba abri capsule etc.Above-mentioned medicine is treated hepatitis B with different treatment methods, and curative effect is very slow, some improve symptom still can, but its hepatitis B cause of disease label negative conversion rate and liver function recovery are slow, even for the several years, and must not heal.

Summary of the invention

Therefore, still there is demand in people for the Chinese medicine preparation of the treatment chronic hepatitis of better efficacy.Up to now, also do not find the report of any relevant pharmaceutical composition of the present invention.The inventor is according to the practical experience of theory of Chinese medical science and long-term clinical treatment, and through the modern crafts development, found the oral medicinal herb medicine of the more definite treatment chronic hepatitis of a kind of curative effect finally, thereby finished the present invention.

Purpose of the present invention is exactly the pharmaceutical composition that a kind of treatment chronic hepatitis of better efficacy will be provided.

Another object of the present invention provides this preparation of drug combination method.

Pharmaceutical composition of the present invention selects for use 8 flavor crude drug such as Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Curcumae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Glycyrrhizae to be prepared from, has replenishing QI to invigorate the spleen, nourishing blood and promoting blood circulation, soothing the liver easing the affected liver effect, can be used for treating chronic hepatitis, disease is seen the empty asthenia of body, poor appetite, dull pain in liver, abnormal liver function person.Wherein used Radix Ginseng, sweet, flat, strongly invigorating primordial QI, strengthening the spleen promotes the production of body fluid, and is used for asthenia, indigestion and loss of appetite, abdominal distention, and have concurrently and calm the nerves, to weakness due to chronic disease, the key medicine of setting upright for tonify deficiency.The spleen reinforcing of energy QI invigorating, mind tranquilizing and the heart calming; The convergence of Fructus Schisandrae Chinensis sour in the mouth, warm in nature not hot not dry, the nourishing kidney of astringing the lung, on the gas of astringing the lung, following nourishing kidney-yin, the clinical hepatitis sick active stage of being used for, remarkable transaminase lowering effect is arranged, and be usually used in neurasthenia's disease such as have a sleepless night, Radix Ginseng, Fructus Schisandrae Chinensis have replenishing QI to invigorate the spleen, hold back the liver effect of reducing enzyme levels is monarch drug in the side.Radix Salviae Miltiorrhizae, hardship is slightly cold, blood circulation promoting and blood stasis dispelling, removing heat from blood, nourishing blood to tranquillize the mind, " the sensible opinion of married woman " thinks Radix Salviae Miltiorrhizae simply, and merit is with four things (Radix Angelicae Sinensis, Radix Rehmanniae, Rhizoma Chuanxiong, Radix Paeoniae), and the effect of invigorating blood circulation is excellent.In recent years research is used for the treatment of enlargement of chronic disease liver and coronary heart disease etc.; Radix Angelicae Sinensis can be invigorated blood circulation, and can enrich blood again, and Gan Wen and moistening, Xin Xiang are good at walking, and Radix Angelicae Sinensis also has the effect of removing blood stasis; Radix Curcumae, arduous cold in nature, can go into edema caused by disorder of QI with promoting QI circulation for relieving depression, soothing the liver promoting the circulation of QI, stasis-dispelling and pain-killing, promoting the function of the gallbladder to alleviate jaundice is gone into blood system with the removing heat from blood removing blood stasis with potent drugs, is used for qi depression to blood stasis, diseases such as the breast side of body and liver pain, jaundice.Above-mentioned Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Curcumae three medicines are taken principal drug assistance altogether and are reached replenishing QI to invigorate the spleen, promoting blood circulation to remove obstruction in the collateral, and dispersing the stagnated live-QI to relieve the stagnation of QI act as ministerial drug.The Fang Zhongyong Radix Paeoniae Alba, hardship, acid is slightly cold, and goes into Liver Channel, the yin fluid astringing that nourishes blood, nourishing blood to suppress the hyperactive liver, emergency and pain relieving can be used for the pain in chest and hypochondrium due to the disharmony in liver-QI, and the Radix Paeoniae Alba suppressing the hyperactive liver that nourishes blood is longer than yin fluid astringing; The Fang Zhongyong Pericarpium Citri Reticulatae, suffering, hardship, temperature, regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm and in disappear stagnantly, be to say that with Compendium of Material Medica it " then mends with tonic, then rush down with cathartic; then rise with Hydrargyri Oxydum Rubrum, with falling medicine and falling ", can strengthen the regulating qi-flowing for strengthening spleen function, the above-mentioned Radix Paeoniae Alba, Pericarpium Citri Reticulatae are adjuvant drug to help monarch-minister drug.The Fang Zhongyong Radix Glycyrrhizae, relaxing all medicine property of medicine, and gas and tonifying the spleen and stomach in can benefit, coordinating the actions of various ingredients in a prescription is a messenger drug.

The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each crude drug consumption proportion of preparation pharmaceutical composition of the present invention all has better curative effect in following ranges:

Radix Ginseng 22～27 weight portions, Fructus Schisandrae Chinensis 14～18 weight portions, Radix Salviae Miltiorrhizae 10～14 weight portions, Radix Angelicae Sinensis 12～17 weight portions, Radix Curcumae 8～12 weight portions, the Radix Paeoniae Alba 12～17 weight portions, Pericarpium Citri Reticulatae 8～12 weight portions and Radix Glycyrrhizae 8～12 weight portions.

Be preferably: Radix Ginseng 25 weight portions, Fructus Schisandrae Chinensis 16 weight portions, Radix Salviae Miltiorrhizae 12 weight portions, Radix Angelicae Sinensis 15 weight portions, Radix Curcumae 10 weight portions, the Radix Paeoniae Alba 15 weight portions, Pericarpium Citri Reticulatae 10 weight portions and Radix Glycyrrhizae 10 weight portions.

Active ingredient in pharmaceutical of the present invention can prepare in order to the below method:

A) with the Pericarpium Citri Reticulatae shredding, all the other crude drug of respectively distinguishing the flavor of are worn into coarse powder;

B) get Radix Angelicae Sinensis, Radix Curcumae coarse powder and Pericarpium Citri Reticulatae filament, add 5--10 times of water gaging and soaked 5--10 hour, steam distillation extracted volatile oil 2--8 hour, volatile oil with the beta-schardinger dextrin-bag and, standby; Water liquid filters, and concentrates standby;

C) medicinal residues behind the extraction volatile oil and Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Radix Glycyrrhizae coarse powder merge, and add 5--15 and doubly measure 30-85% alcohol heating reflux extraction 1--3 time, each 1--3 hour, filter, merging filtrate, decompression recycling ethanol extremely do not have pure flavor;

D) at c) integrate with the concentrated solution that extracts medical materials such as Radix Angelicae Sinensis behind the volatile oil in the gained filtrate, continue to be concentrated into relative density and be 1.30～1.35 concentrated solution, carry out drying under reduced pressure, dry thing is ground into fine powder, the beta-schardinger dextrin-bag and the thing that add volatile oil, mix homogeneously had both got active ingredient in pharmaceutical of the present invention.

Pharmaceutical composition of the present invention can be with its active component and/or acceptable accessories, mix as drug excipients such as disintegrating agent, lubricant, binding agents, be prepared into any peroral dosage form commonly used with conventional method of Chinese medicinal, as capsule, soft capsule, tablet, drop pill, granule, powder or oral liquid etc.

Pharmaceutical composition of the present invention has benefiting QI for activating blood circulation, and the effect of soothing liver-QI easing the affected liver can be used for treating chronic hepatitis, and disease is seen dull pain in liver, weak poor appetite and abnormal liver function person.

The specific embodiment

Below by test the example further set forth pharmaceutical composition of the present invention (to call excellent proheparin capsule in the following text) beneficial effect.

[test example 1] excellent proheparin capsule causes the influence of chmice acute hepatic injury to D-Gal

One, test objective:

D-amino rice lactose (D-GlaN) is the agent interfering of hepatocyte phosphoric acid uridine, can cause liver diffuse necrosis and inflammation, similar to the pathological change of clinical disease virus hepatitis, this test adopts D-GlaN that mice is caused acute liver damage, and that observes various dose is subjected to the repair of reagent to damage.

Two, test material:

1, excellent proheparin capsule:

Mainly form by Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Curcumae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, functions such as QI invigorating, spleen invigorating, nourishing blood and promoting blood circulation, soothing the liver easing the affected liver are arranged, be mainly used in chronic hepatitis clinically, every 1g patent medicine (capsule 's content) is equivalent to the 5.6g crude drug, clinical plan consumption 3g patent medicine/day, be equivalent to 0.05g patent medicine (0.28g crude drug)/kg, this medicine is provided by Yi Kang institute of materia medica, high and new technology industrial development zone, Zhengzhou City, lot number 041120 is made into the suspension of desired concn for irritating stomach usefulness with 0.5%CMC-Na during experiment.

2, FUFANG BIEJIA RUANGAN PIAN (positive control drug):

The sepia Chinese medicinal tablet mainly is made up of Carapax Trionycis, Cordyceps, purple river grass etc., and the effect of hard masses softening and resolving, dissolving blood stasis and detoxication, benefiting QI and nourishing blood is arranged, and is used for chronic hepatitis B, hepatic fibrosis.Every heavy 0.5g, consumption per day 6g (0.1g/kg), authentication code: the accurate word z19991011 of traditional Chinese medicines, is mixed with suspension with the tablet porphyrize with 0.5%CMC-Na during experiment the filling stomach is provided at the date of manufacture 040310.

Three, laboratory animal:

1, Kunming mouse: the animal quality certification number: the moving word 0001582 of doctor

2, Wistar rat: the animal quality certification number: the moving word 0001581 of doctor

All available from Henan Province's Experimental Animal Center, conventional feed is fed.Amount of drinking water is not limit, 22～25 ℃ of experiment room temperatures, relative humidity 50-60%.

Four, reagent:

D-Gal: make the medication of acute liver damage model, be white powder, produce the date of manufacture by Shanghai reagent two factories: 041102, prepare with normal saline during experiment, use for subcutaneous injection.

Five, experiment grouping and method:

The buck of 60 25-28g is divided into 6 groups at random, 10 every group.

1, blank group: 0.5%CMC-Na 0.2ml/10g * 3ig.

2, model control group: 0.5%CMC-Na 0.2ml/10g * 3ig.

3, suspension 0.2ml/10g * 3ig of positive controls (FUFANG BIEJIA RUANGAN PIAN): 2.7g/kg 13.5% is equivalent to 27 times of clinical consumption.

4, excellent proheparin low dose group: 2.5g crude drug/kg 2.25% patent medicine suspension 0.2ml/10g * 3ig is equivalent to 9 times of clinical plan consumption.

5, dosage group in the excellent proheparin: 5.04g crude drug/kg 4.5% patent medicine suspension 0.2ml/10g * 3ig is equivalent to 18 times of clinical plan consumption.

6, excellent proheparin high dose group: 7.56g crude drug/kg 6.75% patent medicine suspension 0.2ml/10g * 3ig is equivalent to 27 times of clinical plan consumption.

Method: 1, animal fasting 12 hours before experiment, test 7Am on the same day, 11Am and 3pm.Irritate stomach altogether 3 times by above-mentioned dosage.

2, last irritate stomach after 1 hour except that the blank group, each animal all once (is mixed with 8% aqueous solution, 0.1ml/10g ip with NS) through back subcutaneous injection D-GlaN800ml/kg.

3, behind the injection D-GlaN 24 hours, the sacrificed by decapitation animal was got blood and surveys ALT, AST, and gets liver through formalin fixed, and HE dyeing is carried out histopathology and observed, and takes pictures.

Six, experimental result:

1, ALT, AST laboratory examination:

The ALT of a, model group, AST laboratory values are all apparently higher than the blank group, and p all＜0.01.

B, positive group are lower than model group, and p all＜0.05.

The ALT of c, low dose group and model group no significant difference, p＞0.05.

D, middle and high dosage group all are lower than model group, and p all＜0.05.

2, hepatic tissue pathology histological examination:

A, blank group: liver: the lobules of liver structure is normal, and liver rope, central vein, portal area structure are normal, no abnormal.

B, model group: liver: the lobules of liver structure disturbance, the hepatocyte edema, degeneration, it is unclear to demarcate, and steatosis is obvious, and focal necrosis is arranged, and big lamellar necrosis appears in a few sample.

Dosage group in c, the excellent proheparin: liver: the lobules of liver structure is slightly disorderly, slight hepatocyte edema and steatosis, and spotty necrosis is rare.

D, excellent proheparin high dose group: liver: the lobules of liver structure is normal substantially, slight hepatocyte hydropic degeneration, and it is clear to demarcate, and steatosis is slight.

E, excellent proheparin low dose group: liver: the disorder of lobules of liver structure moderate, hepatocyte hydropic degeneration moderate, boundary is fuzzy, and steatosis is slight, and spotty necrosis is rare.

F, FUFANG BIEJIA RUANGAN PIAN group: liver: the disorder of lobules of liver structure moderate, the slight hepatic cell degeneration, steatosis is slight, and focal necrosis is arranged, and spotty necrosis is rare.

Seven, conclusion:

Give the excellent proheparin of D-Gal mouse gavaging 5.04g or 7.56g crude drug/kg, can obviously reduce ALT, the AST of mice serum, and the hepatic tissue of damage is had certain repair.

Come further to set forth pharmaceutical composition of the present invention and preparation method thereof by the following examples.

The preparation of [embodiment 1] capsule of the present invention

A) take by weighing Radix Ginseng 25g, Fructus Schisandrae Chinensis 16g, Radix Salviae Miltiorrhizae 12g, Radix Angelicae Sinensis 15g, Radix Curcumae 10g, Radix Paeoniae Alba 15g, Pericarpium Citri Reticulatae 10g and Radix Glycyrrhizae 10g, standby;

B) with the Pericarpium Citri Reticulatae shredding, all the other drug mills of respectively distinguishing the flavor of become coarse powder;

C) get Radix Angelicae Sinensis, Radix Curcumae coarse powder and Pericarpium Citri Reticulatae filament, add 7 times of water gagings and soaked 7 hours, steam distillation extracted volatile oil 5 hours, volatile oil with the beta-schardinger dextrin-bag and, standby; Water liquid filters, and concentrates standby;

D) medicinal residues behind the extraction volatile oil and Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Radix Glycyrrhizae coarse powder merge, and add 10 times of amount 65% alcohol heating reflux and extract 2 times, each 2 hours, filter, merging filtrate, decompression recycling ethanol extremely do not have the alcohol flavor;

E) in previous step gained filtrate, integrate with the concentrated solution that extracts medical materials such as Radix Angelicae Sinensis behind the volatile oil, continue to be concentrated into relative density and be 1.30～1.35 concentrated solution, carry out drying under reduced pressure, dry thing is ground into fine powder, the beta-schardinger dextrin-bag and the thing that add volatile oil, mix homogeneously, the gelatine capsule of packing into.

The gained capsule for the patient oral, one time 2,3 times on the one.

The preparation of [embodiment 2] tablet of the present invention

A) take by weighing each crude drug by following weight proportion:

Radix Ginseng 22g, Fructus Schisandrae Chinensis 14g, Radix Salviae Miltiorrhizae 10g, Radix Angelicae Sinensis 12g, Radix Curcumae 8g, Radix Paeoniae Alba 12g, Pericarpium Citri Reticulatae 8g and Radix Glycyrrhizae 8g, standby;

B) with the Pericarpium Citri Reticulatae shredding, all the other crude drug of respectively distinguishing the flavor of are worn into coarse powder;

C) get Radix Angelicae Sinensis, Radix Curcumae coarse powder and Pericarpium Citri Reticulatae filament, add 5 times of water gagings and soaked 5 hours, steam distillation extracted volatile oil 3 hours, volatile oil with the beta-schardinger dextrin-bag and, standby; Water liquid filters, and concentrates standby;

D) medicinal residues behind the extraction volatile oil and Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Radix Glycyrrhizae coarse powder merge, and add 5 times of amount 85% alcohol heating reflux and extract 2 times, each 3 hours, filter, merging filtrate, decompression recycling ethanol extremely do not have the alcohol flavor;

E) in previous step gained filtrate, integrate with the concentrated solution that extracts medical materials such as Radix Angelicae Sinensis behind the volatile oil, continue to be concentrated into relative density and be 1.30～1.35 concentrated solution, carry out drying under reduced pressure, dry thing is ground into fine powder, the beta-schardinger dextrin-bag and the thing that add volatile oil, use alcohol granulation, dry also compacting in flakes.

The preparation of [embodiment 3] granule of the present invention

A) take by weighing Radix Ginseng 27g, Fructus Schisandrae Chinensis 18g, Radix Salviae Miltiorrhizae 14g, Radix Angelicae Sinensis 17g, Radix Curcumae 12g, Radix Paeoniae Alba 17g, Pericarpium Citri Reticulatae 12g and Radix Glycyrrhizae 12g, standby;

B) with the Pericarpium Citri Reticulatae shredding, all the other crude drug of respectively distinguishing the flavor of are worn into coarse powder;

C) get Radix Angelicae Sinensis, Radix Curcumae coarse powder and Pericarpium Citri Reticulatae filament, add 10 times of water gagings and soaked 10 hours, steam distillation extracted volatile oil 8 hours, volatile oil with the beta-schardinger dextrin-bag and, standby; Water liquid filters, and concentrates standby;

D) medicinal residues behind the extraction volatile oil and Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Radix Glycyrrhizae coarse powder merge, and add 15 times of amount 35% alcohol heating reflux and extract 2 times, each 2 hours, filter, merging filtrate, decompression recycling ethanol extremely do not have the alcohol flavor;

E) in previous step gained filtrate, integrate with the concentrated solution that extracts medical materials such as Radix Angelicae Sinensis behind the volatile oil, continue to be concentrated into relative density and be 1.30～1.35 concentrated solution, carry out drying under reduced pressure, dry thing is ground into fine powder, the beta-schardinger dextrin-bag and the thing that add volatile oil, add ethanol and make adhesive, add starch and make filler, be pressed into granule.

Claims (4)

1. pharmaceutical composition for the treatment of chronic hepatitis, it is made up of active component and/or acceptable accessories, it is characterized in that its contained active component made by the following weight proportion raw material: 8～12 parts in 22～27 parts of Radix Ginsengs, 14～18 parts of Fructus Schisandrae Chinensis, 10～14 parts of Radix Salviae Miltiorrhizaes, 12～17 parts of Radix Angelicae Sinensis, 8～12 parts of Radix Curcumaes, 12～17 parts of the Radix Paeoniae Albas, 8～12 parts of Pericarpium Citri Reticulataes and Radix Glycyrrhizae.

2. according to the described pharmaceutical composition of claim 1, wherein said raw material weight ratio is: 10 parts in 25 parts of Radix Ginsengs, 16 parts of Fructus Schisandrae Chinensis, 12 parts of Radix Salviae Miltiorrhizaes, 15 parts of Radix Angelicae Sinensis, 10 parts of Radix Curcumaes, 15 parts of the Radix Paeoniae Albas, 10 parts of Pericarpium Citri Reticulataes and Radix Glycyrrhizae.

3. according to claim 1 or 2 described pharmaceutical compositions, it is pharmaceutics of Chinese drugs common formulations such as capsule, soft capsule, tablet, drop pill, granule, powder or oral liquid.

4. each described preparation of drug combination method among the claim 1-3, it may further comprise the steps:

A) take by weighing each crude drug of described weight proportion, wherein with the Pericarpium Citri Reticulatae shredding, all the other drug mills of respectively distinguishing the flavor of become coarse powder, and are standby;

B) get Radix Angelicae Sinensis, Radix Curcumae coarse powder and Pericarpium Citri Reticulatae filament, add 5--10 times of water gaging and soaked 5--10 hour, steam distillation extracted volatile oil 2--8 hour, volatile oil with the beta-schardinger dextrin-bag and, standby; Water liquid filters, and concentrates standby;

C) medicinal residues behind the extraction volatile oil and Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Radix Glycyrrhizae coarse powder merge, and add 5--15 and doubly measure 30-85% alcohol heating reflux extraction 1--3 time, each 1--3 hour, filter, merging filtrate, decompression recycling ethanol extremely do not have pure flavor;

D) in step c) gained filtrate, integrate with the concentrated solution that extracts medical materials such as Radix Angelicae Sinensis behind the volatile oil, continue to be concentrated into relative density and be 1.30～1.35 concentrated solution, carry out drying under reduced pressure, dry thing is ground into fine powder, the beta-schardinger dextrin-bag and the thing that add volatile oil, mix homogeneously had both got active ingredient in pharmaceutical of the present invention;

E) with active component and/or and mixing acceptable accessories, be prepared into regular dosage forms such as capsule, soft capsule, tablet, drop pill, granule, powder or oral liquid.