CN101357219A

CN101357219A - Medicine for treating chronic hepatitis b

Info

Publication number: CN101357219A
Application number: CNA2008101508970A
Authority: CN
Inventors: 尚寿鹏; 马德平
Original assignee: LANZHOU FOCI PHARMACY CO Ltd
Current assignee: LANZHOU FOCI PHARMACY CO Ltd
Priority date: 2008-09-04
Filing date: 2008-09-04
Publication date: 2009-02-04
Anticipated expiration: 2028-09-04
Also published as: CN101357219B

Abstract

The invention discloses a medicine for treating chronic hepatitis B, which contains the raw materials by the mixture ratio: 6-18% of herba artemisiae capillaries, 1-7% of Chinese thorowax, 1-7% of angelica, 3-12% of radix paeoniae alba, 3-12% of salvia miltiorrhiza, 1-10% of radix curcumae, 1-7% of rhizoma corydalis, 1-7% of common burreed rhizome, 1-7% of rhizoma zedoariae, 1-7% of nutgrass galingale rhizome, 1-7% of fructus meliae toosendan, 1-10% of dangshen, 1-7% of largehead atractylodes rhizome, 6-18% of radix astragali, 3-12% of indian bread, 1-7% of immature bitter orange, 1-7% of amomum villosum, 1-7% of areca, 0.5-5% of Chinese eaglewood and 1-7% of liquorice; the medicine is prepared by adopting conventional method. The medicine has the efficacies of clearing heat and promoting diuresis, nourishing the liver and invigorating the spleen, regulating the flow of qi and removing blood stasis, and can be used for treating chronic hepatitis B with remarkable effects, short period of treatment and rapid effects.

Description

A kind of medicine that is used for the treatment of chronic hepatitis B

Technical field

The invention belongs to a kind of Chinese medicine preparation, be specifically related to a kind of medicine that is used for the treatment of chronic hepatitis B.

Background technology

(Chronic Viral Hepatitis B CH-B) is a kind of commonly encountered diseases of serious harm human health to chronic viral hepatitis B, and its control has become a global public health problem, causes the concern of countries in the world.China is the district occurred frequently of viral hepatitis, and the average year sickness rate is 120-140/10 ten thousand.Be outstanding with hepatitis B (HB) especially wherein.China's hepatitis B virus (HBV) infection rate is up to 57.63%, and promptly the whole nation has at least 600,000,000 people to infect HBV.HBsAg positive rate 9.75% has 1.2 hundred million people approximately, accounts for 1/3 of the whole world; Wherein about 1/4 will develop into chronic hepatopathy, and part patient can develop into liver cirrhosis, even develop into hepatocarcinoma.Existing disease chronic viral hepatitis B patient more than 2,000 ten thousand people are arranged at present.There are every year 23.7 ten thousand people to die from the relevant disease of hepatitis B, wherein have 15.6 ten thousand people to die from hepatocarcinoma.Hepatitis B is serious harm China people's health not only, but also bring serious social economic burden for country.The treatment time of chronic viral hepatitis B is long, and medical expense is higher, adds Drug abuse, has more increased the weight of extra financial burden.

The chronic hepatitis B pathogeny is complicated, and many contradiction is compiled all over the body.Existing with hepatitis B continue have organism immune dysfunction again; Existing hepatocellular inflammation, necrosis have the liver proliferation of fibrous tissue again; Accumulate in the existing pyretic toxicity, obstruction of collaterals by blood stasis, deficiency of qi and yin are arranged again; The pathological changes of existing liver own also has the liver external system to change.Therefore for each chronic hepatitis B patient except that common feature is arranged, its personal characteristics is more arranged.Still do not have under the situation of sure specific medicament in treatment at present, the doctor need be on overall understanding state of an illness basis, as far as possible according to the different phase of its course of disease and the state of an illness and patient's individual characteristic, dialectical disposal, rational use of drug.

Aspect treatment, the Therapeutic Principle for chronic viral hepatitis B regulates organism immune response at present, suppresses virus replication, also answers necrosis---inflammation fibrosis simultaneously, stops to carrying out the hepatopathy development.A series of anti-HBV medicines, end is got up, and nothing more than two mechanism: (1) removes infected hepatocellular HBV by regulating immunoreation; (2) directly suppress virus replication, the healthy liver that prevents infections cell.Remove interferon-ALPHA, thymosin and new nucleoside analogues beyond the region of objective existence at present, the antivirus action of most drug is not confirmed.Interferon is a line medicine of the treatment chronic viral hepatitis B of generally acknowledging, but costs an arm and a leg, and response rate is low, and side effect is big; Though rummy husband fourth is considered to treat at present the most promising medicine of chronic hepatitis B, easily recurrence after the drug withdrawal, and can cause the hepatitis B virus sudden change, produce drug resistance.And regulating immunity of organisms and preventing that selectable medicine is few aspect the hepatic fibrosis, and side effect is bigger, and uncertain therapeutic efficacy is cut.Modern medicine has all been done more deep research to aspects such as the pathogen of chronic hepatitis B, epidemiology, natural history, pathogenesis, pathological changes, but still fails to find the hepatitis b virus infected medicine of thorough treatment.

The treatment by Chinese herbs hepatitis B has shown its advantage in every respect, because herbal species is many, classical prescription, proved recipe are many, treats the screening of hepatitis B medicine by a large amount of work, therefrom finds hepatitis B real effectively medicine and active component.Closely during the last ten years, effort by China medicine worker, the external work that Chinese medicine has been carried out antiviral, fallen enzyme, improves aspects such as immunologic function, hepatoprotective and active ingredient control in vivo,, obtained achievement preferably, produced and a collection ofly comprise that injection, oral liquid, electuary, capsule, decoction, tablet and the anti-agent of external etc. are to preparations such as the effective compound recipe of hepatitis B, folk prescription, active ingredients.At present, the medicine category of commercially available treatment hepatopathy is numerous and complicated, and effect is different, but with respect to hepatopathy mechanism complexity, most medicines seem and attend to one thing and lose sight of another that curative effect is not ideal enough.

Summary of the invention

The purpose of this invention is to provide a kind of medicine that is used for the treatment of chronic hepatitis B that the treatment chronic hepatitis B is had significant curative effect.

For achieving the above object, drug component of the present invention and consumption draw by groping in a large number to sum up, and each component weight percent content is: Herba Artemisiae Scopariae 6～18%, Radix Bupleuri 1～7%, Radix Angelicae Sinensis 1～7%, the Radix Paeoniae Alba 3～12%, Radix Salviae Miltiorrhizae 3～12%, Radix Curcumae 1～10%, Rhizoma Corydalis 1～7%, rhizoma sparganic 1～7%, Rhizoma Curcumae 1～7%, Rhizoma Cyperi 1～7%, Fructus Toosendan 1～7%, Radix Codonopsis 1～10%, the Rhizoma Atractylodis Macrocephalae 1～7%, the Radix Astragali 6～18%, Poria 3～12%, Fructus Aurantii Immaturus 1～7%, Fructus Amomi 1～7%, Semen Arecae 1～7%, Lignum Aquilariae Resinatum 0.5～5%, Radix Glycyrrhizae 1～7%.

The preferred weight percent content of drug component of the present invention is: Herba Artemisiae Scopariae 11.36%, Radix Bupleuri 3.41%, Radix Angelicae Sinensis 3.41%, the Radix Paeoniae Alba 7.58%, Radix Salviae Miltiorrhizae 7.58%, Radix Curcumae 5.68%, Rhizoma Corydalis 3.41%, rhizoma sparganic 3.41%, Rhizoma Curcumae 3.41%, Rhizoma Cyperi 3.41%, Fructus Toosendan 3.41%, Radix Codonopsis 5.68%, the Rhizoma Atractylodis Macrocephalae 3.41%, the Radix Astragali 11.36%, Poria 7.58%, Fructus Aurantii Immaturus 3.41%, Fructus Amomi 3.41%, Semen Arecae 3.41%, Lignum Aquilariae Resinatum 2.27%, Radix Glycyrrhizae 3.41%.

Wherein: described Radix Bupleuri, Rhizoma Corydalis, Rhizoma Curcumae, Rhizoma Cyperi carry out processed according to the vinegar system method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one); Rhizoma sparganic carries out processed according to the concocting method that this kind item of Chinese Pharmacopoeia (2005 editions an one) is stipulated down; The Radix Paeoniae Alba, Fructus Toosendan carry out processed according to the concocting method that this kind item of Chinese Pharmacopoeia (2005 editions an one) is stipulated down; The Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus carry out processed according to the parched with bran method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one); Radix Codonopsis, the Radix Astragali, Radix Glycyrrhizae carry out processed according to the processed with honey method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one).

Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared from.Medicine of the present invention is a said dosage form on any pharmaceutics, is generally oral preparations, for example: tablet, capsule, granule, drop pill, soft capsule, enteric coated preparation, targeting preparation, slow releasing preparation etc.

Medicament selection Radix Bupleuri of the present invention, Rhizoma Cyperi, Fructus Toosendan, Fructus Aurantii Immaturus, Lignum Aquilariae Resinatum, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Radix Curcumae, Rhizoma Corydalis, rhizoma sparganic, Rhizoma Curcumae, Semen Arecae, Fructus Amomi, Herba Artemisiae Scopariae, Poria, Radix Codonopsis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae make up, make each efficacy of drugs produce synergism, thereby can effectively treat hepatopathy.Reach irritability with the Radix Bupleuri bar in the side; With liver-smoothing, qi-regulating, regulating functional activities of qi such as Rhizoma Cyperi, Fructus Toosendan, Fructus Aurantii Immaturus, Lignum Aquilariae Resinatum; With nourishing blood and dissolving stasises such as Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Radix Curcumae, Rhizoma Corydalis; Amass with removing blood stasiss such as rhizoma sparganic, Rhizoma Curcumae, mill eliminating mass.Aspect blood circulation promoting and blood stasis dispelling the weight drug combination, with the effect of enhancingization disease removing food stagnancy.Again with dyspepsia and intestinal stasis relieving such as Semen Arecae, Fructus Amomis.Clearing liver-gallbladder such as Herba Artemisiae Scopariae, Poria.A little less than the existing strong spleen of liver of hepatopathy multilist, deficiency of both QI and blood is so we are again with spleen invigorating, QI invigorating, hemopoietics such as Radix Codonopsis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalaes.Wherein: the main component of Radix Bupleuri is volatile oil, saponin etc., and the water logging agent of Radix Bupleuri and decoct (1: 20) all can make total bile output of dog and bile salt component increase.Bupleurum preparation has certain therapeutical effect to the hepatic insufficiency that bacillary and Different types of etiopathogenises (antityphoid vaccine, ethanol, carbon tetrachloride, mouldy rice, galactosamine etc.) cause.Zoopery liver injury due to carbon tetrachloride and penicillin mould etc. there is significant anti-damaging action; The Rhizoma Cyperi main component is a volatile oil, and as α-cyperone, different cyperone etc., its decoct can promote bile secretion, improves bile flow, and the hepatocyte function to the carbon tetrachloride hepatic injury rat has protective effect simultaneously; The main component of Fructus Toosendan is Toosendanin, violet incense ketoside etc., nervous system, cardiovascular system, digestive system all there are effect, show after the healthy human oral Fructus Toosendan decoct lax Oddi's sphincter is arranged according to ultrasound investigation, shrink gallbladder, promote the bile excretion effect; The Fructus Aurantii Immaturus main component is volatile oil, flavonoid glycoside, alkaloid etc., cardiovascular system, reproductive system is had effect, and have diuresis, antiinflammatory action; The Lignum Aquilariae Resinatum main component is volatile oil, chromone compounds and derivant, callus chemical constituent, and the central nervous system is had active and the spasmolytic effect of suppressing; The Radix Angelicae Sinensis main component is volatile oil, saccharide, aminoacid and ferulic acid, vitamin B ₁₂, vitamin A etc., cardiovascular system, blood system, immune system, central nervous system, digestive system, respiratory system all there is effect, and have antioxidation and remove free radical effect, Antiradiation injury effect, antitumor action, anti-inflammatory, antibacterial effect etc., clinical proof: Radix Angelicae Sinensis can make patient's thymol turbidity reduce, the Radix Angelicae Sinensis meals are raised mice, the hepatic tissue endogenous is breathed and is strengthened, and the ability of oxidation glutamic acid significantly improves.Studies show that: Radix Angelicae Sinensis can prevent that to the hepatic injury of chmice acute carbon tetrachloride poisoning the white mice hepatic glycogen from reducing, and protection cell ATP enzyme, G-6-Pase etc. and active illustrate that Radix Angelicae Sinensis has irregular effect to protecting hepatocyte and recovering some function of liver; Radix Paeoniae Alba main component is peoniflorin, paeonol etc., and immune system, central nervous system, digestive system, cardiovascular system etc. are all had effect, and have antiinflammatory, anti-swash should, the effect of resisting pathogenic microbes, liver is had protective effect; The Radix Salviae Miltiorrhizae main component is Tanshinone I, Tanshinone I I _A, salviol etc., tool stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the effect of the relieving restlessness that clears away heart-fire; The Radix Curcumae main component is volatile oil (linalool, curzerenone etc.), curcumin chemical compounds etc., and immune system, urinary system, blood circulation are all had effect, has antiallergic, antioxidation, antiinflammatory, antibacterial, hepatoprotective effect; The Rhizoma Corydalis main component is an alkaloid, as corydaline, tetrahydropalmatine etc., have invigorate blood circulation, promoting the circulation of QI, analgesic effect; The rhizoma sparganic main component is a volatile oil, as Ethyl formate, capryl alcohol, phenethanol etc., has anticoagulation anti-thrombosis function etc.; The Rhizoma Curcumae main component is volatile oil γ-pinene, nopinene, terpinene, isoborneol, curzerenone etc., has anti-experimental character hepatic injury effect etc.; The Semen Arecae main chemical compositions is alkaloid (arecoline, arecaidine, guvacoline etc.), fatty oil (lauric acid, myristic acid, Palmic acid etc.), have anthelmintic, resisting pathogenic microbes, bring high blood pressure down, effect such as anticancer, the effect of digestive system shown as rush down down, strengthen the ductus choledochus contractility, quicken bile and discharge; The Fructus Amomi main component is Camphora, borneol acetate etc., has former mice thrombosis that brings out with the epinephrine intermixture of anticol and acute death effect, antiulcer action, the analgesic activity that is caused thereof, can the removing dampness appetizing, warming spleen and stopping diarrha, regulate the flow of vital energy antiabortive; The Herba Artemisiae Scopariae main component is Coumarins, chromogen ketone, flavonoid, volatilization wet goods, has function of gallbladder promoting, protects the liver, the effect of analgesic, blood fat reducing, blood pressure lowering, resisting pathogenic microbes, raising body immunity; The Poria main component is polysaccharide, triterpenes, fatty acid etc., has effects such as antitumor, diuresis, enhancing immunity, analgesia, and myocardial contraction is strengthened, and heart rate is accelerated; The Radix Codonopsis main component is sterols, sugar and glycoside, alkaloid and nitrogen containing component etc., has invigorating the spleen and replenishing QI, the effect of spleen invigorating lung benefiting; Radix Astragali main component is triterpenoid saponin, flavonoid, aminoacid etc., has invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, the effect of expelling pus and promoting granulation; Rhizoma Atractylodis Macrocephalae main component is volatile oil (atractylone, atractylol, atractyloxide etc.), acetylene compound etc.; the effect that have function of gallbladder promoting, protects the liver etc.; experimentation shows; Rhizoma Atractylodis Macrocephalae decoct is oral to have protective effect to mice because of the hepatic injury that carbon tetrachloride causes; can reduce the hepatocellular degeneration necrosis, promote the growth of liver, prevent the minimizing of liver glycogen; the recovery of short DNA (deoxyribonucleic acid) has diuresis simultaneously, strengthens effects such as body immunity, blood sugar lowering.

Medicine of the present invention has clearing away heat-damp and promoting diuresis, the liver soothing and the spleen invigorating, the effect of regulating the flow of QI to dissipate blood stasis is mainly used in the chronic hepatitis B stagnation of liver-QI with deficiency of the spleen, accumulates in warm, syndrome of qi stagnation and blood stasis, card is seen: hypochondriac pain, gastral cavity abdominal distention are vexed, detest greasy, nausea and vomiting, fatigue and weak.Therapeutic effect is remarkable, has convenient oral, short treating period, instant effect, does not see obvious toxicity, clinical safe and reliable advantage.

Below further set forth the beneficial effect of medicine of the present invention by the test example, these tests comprise that a kind of dosage form big honeyed pills of medicine of the present invention is (to call in the following text: pharmacodynamics test soothing liver-QI removing food stagnancy ball), animal acute toxicity test, long-term toxicity test for animals, clinical observation on the therapeutic effect test.

Test example one: medicine soothing liver-QI removing food stagnancy ball pharmacodynamics test of the present invention

The protective effect of 1 pair of experimental hepatic injury

1.1 test material

1.1.1 medicine: soothing liver-QI removing food stagnancy ball fine powder is concentrated into the extractum shape with 45% soak with ethanol after 72 hours in 80 ℃ of water-baths, prepare desired concn with normal saline during experiment.It is restriction factory product that phenyl isothiocyanate (APIT) is learned approximately for The 2nd Army Medical College, liquid state, and every ml contains 1.13g, dilutes with olive oil.

1.1.2 experimental animal: test with 18～22g Kunming kind closed colony white mice; 200～300gWistar kind rat; 2.0～2.5Kg white rabbit, the male and female dual-purpose.

1.2 test method and result

1.2.1 phenyl isothiocyanate is brought out the influence of rats'liver damage

40 of rats are divided into 4 groups at random.Normal control group and APIT group normal saline are irritated stomach, every day 1 time, continuous 6 days.Soothing liver-QI removing food stagnancy ball (low dose) group is irritated stomach respectively with soothing liver-QI removing food stagnancy ball (heavy dose) group, and soothing liver-QI removing food stagnancy ball is equivalent to crude drug in whole 5g/Kg and 10g/Kg every day 1 time, continuous 6 days.Each treated animal was all irritated stomach APIT113mg/Kg except that the normal control group in the 6th day.Put to death rat extracting blood after 48 hours, measure serum glutamic pyruvic transminase (SGPT) serum bilirubin (SB); Get liver and claim weight in wet base, 10%Formalin fixes, and does histopathologic examination.Paraffin embedding, section, HE dyeing is observed and is respectively organized the change of liver organization cytopathology, and contrasts.

With KingShi improved method SGPT, the azo agents method is measured SB.

Each organizes rat SGPT and SB measurement result, and is as shown in table 1.

Table 1 soothing liver-QI removing food stagnancy ball is to the influence of rat experiment jaundice model

^*Compare P＜0.001 with the normal control group ^*Compare P＜0.001 with the APIT group ^{* *}Compare P＜0.01 with the normal control group

The hepatic tissue cell pathologic finding shows, the normal control group, and the lobules of liver structural integrity, central vein and hepatic cords are arranged normal, and sinus hepaticus does not have the expansion blood stasis, does not have strongly fragrant gallbladder phenomenon; APIT group, granular degeneration is filled the air in the obvious swelling of hepatocyte, and part of hepatocytes has steatosis and acidophilia to become, and the sinus hepaticus pressurized is irregular, and matter has mononuclear cell and lymphocytic infiltration between lobule, change such as little vasodilation hyperemia between lobule; Soothing liver-QI removing food stagnancy ball (low dose) group, the central veins of hepatic lobules dilatation and congestion, the hepatocyte granular degeneration, the Kupffer hypertrophy, the sinus hepaticus pressurized narrows down, and does not see that fat becomes and the acidophilia becomes; Soothing liver-QI removing food stagnancy ball (heavy dose) group, the central veins of hepatic lobules dilatation and congestion, the liver rope is arranged and is recovered normal, and the slight hepatic cell granular degeneration does not see that hepatocyte fat becomes and the acidophilia becomes.

1.2.2 to CCl ₄Bring out the influence of mouse liver injury

40 of mices are divided into 4 groups at random.Normal control group and CCl ₄Group is irritated the stomach normal saline respectively, every day 1 time, continuous 5 days.Soothing liver-QI removing food stagnancy ball (low dose) group and soothing liver-QI removing food stagnancy ball (heavy dose) group are irritated stomach respectively, and soothing liver-QI removing food stagnancy ball is equivalent to crude drug in whole 5g/Kg and 10g/Kg, every day 1 time, continuous 5 days.All the other respectively organized mouse subcutaneous injection 0.1%CCl except that the normal control group in the 5th day ₄, olive oil 10ml/Kg.Put to death mice after 24 hours and get blood,, the results are shown in Table 2 with KingShi improved method SGPT.

Table 2 soothing liver-QI removing food stagnancy ball is to CCl ₄The influence of damage mice SGPT

^*Compare P＜0.001 with the normal control group ^*With CCl ₄Group is P＜0.001 relatively

It is liquid-solid fixed with 10%Formalin to get liver, paraffin embedding, and section, the hepatic tissue cell pathologic finding is done in H.E. dyeing.The normal control group, the lobules of liver structural integrity, central vein is positioned at lobule central authorities, and the liver rope is radial arrangement, and sinus hepaticus does not have dilatation and congestion, and hepatocyte is no abnormal; CCl ₄Group, the lobules of liver soft edge, central vein hyperemia, the liver rope is arranged and is not radial, the obvious swelling of hepatocyte, the loose abortive haul shape that is of endochylema, visible balloon sample becomes, and the acidophilia becomes and the necrosis of special mess shape.Mononuclear cell, lymphocytic infiltration are arranged in the matter between lobule; Soothing liver-QI removing food stagnancy ball (low dose) group, hepatic cords is misaligned, the central vein mild hyperaemia, obvious granular degeneration of hepatocyte and puffing, the sinus hepaticus pressurized narrows down, and the hepatocyte acidophilia becomes; Soothing liver-QI removing food stagnancy ball (heavy dose) group, leaflet structure is complete, and hepatic cords is arranged and is radial, and central vein does not have the expansion blood stasis, the slight granular degeneration of hepatocyte, sinus hepaticus is high-visible, does not see downright bad the change.

1.2.3 choleretic effect to rabbit

10 of rabbit are divided into 2 groups at random, urethane 1g/Kg intravenous anesthesia, cut the abdominal cavity open, the ligation ductus choledochus inserts polyethylene catheter and collects bile in gallbladder, collect the choleresis of 30min before the administration, every 30min writes down choleresis once after the administration, totally 4 times.The matched group rabbit is through capacity normal saline such as duodenum injection and administrations, and experimental group injects soothing liver-QI removing food stagnancy ball 5g/Kg by duodenum, calculates the bile secretion increment rate as follows.

Experimental result shows that bile flow obviously increases in the soothing liver-QI removing food stagnancy ball duodenal administration 30min, and the bile secretion increment rate is 82.2 ± 19.1% (P＜0.01).The bile secretion increment rate is 65.8 ± 23.7% (P＜0.05) in the administration 60min.The interior bile secretion increment rate of 90min is then not obvious to be 23.2 ± 21.1% (P＞0.05).

1.2.4 to CCl ₄The influence of poisoning mice pentobarbital sodium length of one's sleep

30 of white mice are divided into 3 groups at random.Normal control group and CCl ₄Group is irritated capacity normal saline such as stomach, and soothing liver-QI removing food stagnancy ball group is irritated stomach soothing liver-QI removing food stagnancy ball 5g/Kg, every day 1 time, continuous 5 days.The 5th day except that the normal control group, subcutaneous injection 1%CCl simultaneously ₄Olive oil 10ml/Kg.The 6th day 3 groups of equal lumbar injection pentobarbital sodium of mice 30mg/Kg.Observe mice sleep induction period and recovery time, the results are shown in Table 3.

Table 3 soothing liver-QI removing food stagnancy ball is to CCl ₄The influence of poisoning mice pentobarbital sodium length of one's sleep

^*Compare P＜0.001 with the normal control group ^*Compare P＞0.05 with the normal control group

CCl ₄The poisoning mice pentobarbital sodium sleep derivation phase obviously shortens, recovery time significant prolongation, soothing liver-QI removing food stagnancy ball is to CCl ₄No significant difference between poisoning mice pentobarbital sodium sleep derivation phase and convalescent period and the normal control group illustrates that soothing liver-QI removing food stagnancy ball has powerful protective effect to liver.

1.3 conclusion

Prepared whole animal experimental model in the research of this experimental hepatitis is the classical way commonly used that is used for studying the effect of medical treatment hepatopathy, and CCl is arranged ₄Toxic liver injury model and cholestasis jaundice model etc.The former passes through CCl ₄In liver, combine with cytochrome P-450, produce free radical, thereby make lipid oxidation, form the peroxide of lipid, influence the functional group on the protein, particularly the SH base is destroyed other structures of endocytoplasmic reticulum and cell, GPT in the endochylema etc. overflows in the blood, makes the active obviously rising of these enzymes in the blood.The once heavy dose of acute poisoning of phenyl isothiocyanate, can cause that blood mesobilirubin and SGPT sharply raise, bile flow reduces, and the interior bile capillary of hepatocyte injury and liver damages and causes liver internal congestion jaundice, is the new hepatic of research both at home and abroad at present and the common experimental model of function of gallbladder promoting medicine.

This research uses these two kinds of livers to decrease animal model, and the result shows, CCl ₄After the chmice acute hepatic injury 24 hours, SGPT can raise rapidly, than normal level up to 13 times about, after the hepatic injury of phenyl isothiocyanate rat acute 48 hours, SGPT rose suddenly to about 7 times of normal level.Under liver function major injury situation like this, soothing liver-QI removing food stagnancy ball 5-10g/kg, medication 5-6 days, can reduce the effect of SGPT very significantly, show that this product has very strong protective effect to hepatocyte.

Behind the phenyl isothiocyanate rat oral gavage 48 hours, SB is elevated to 4.28 ± 0.23mg/dL, is higher than about 17 times of rat normal values.Proof this product has the SB rising that obvious antagonism phenyl isothiocyanate causes, experimental jaundice is had unique jaundice eliminating effect.

The experiment of rabbit bile flow also can be seen, and soothing liver-QI removing food stagnancy ball has the effect of remarkable increase bile flow, and this is consistent with the experimental result that the rat jaundice disappears.So think this product jaundice eliminating and the effect of soothing liver-QI removing food stagnancy, may be relevant with its effect that can significantly increase bile secretion.

Soothing liver-QI removing food stagnancy ball is to CCl ₄The poisoning mice pentobarbital sodium length of one's sleep and normal mouse pentobarbital sodium comparison length of one's sleep no difference of science of statistics.Soothing liver-QI removing food stagnancy ball experimental group and CCl ₄The poisoning treated animal is compared, and the latter prolongs the pentobarbital sodium sleep significantly.This experiment further points out soothing liver-QI removing food stagnancy ball to CCl ₄Hepatic injury has good protective effect.

From pathological tissue cytolgical examination result, no matter be CCl ₄Or phenyl isothiocyanate, soothing liver-QI removing food stagnancy ball treated animal liver tissue lesions is all light than matched group.Particularly the difference of hepatic necrosis degree is more remarkable.The necrosis of tangible kitchen range shape appears in matched group, and soothing liver-QI removing food stagnancy ball group then shows kitchen range shape necrotic extent and dwindles, even does not have necrosis.This result has important relation to the prognosis of hepatic injury.Think that the reticular fiber support subsided when the necrosis of kitchen range shape appearred in hepatocyte, when liver cell regeneration,, then be irregular nodular pattern, lose the 26S Proteasome Structure and Function of original lobule, can develop into liver cirrhosis for a long time owing to lost original support.

In sum, effects such as soothing liver-QI removing food stagnancy ball not only has the hepatocellular degeneration of alleviating, necrosis, the jaundice that disappears, function of gallbladder promoting, and take place also significant to the prevention liver cirrhosis.The experimental studies results of this respect is consistent with the clinical effectiveness of soothing liver-QI removing food stagnancy ball, so this medicine is comparatively ideal treatment hepatitis new drug.

2 pairs of hemorheological influences

2.1 test material

2.1.1 medicine: soothing liver-QI removing food stagnancy ball fine powder, irritating the stomach preparation is that fine powder is concentrated into the extractum shape with 45% soak with ethanol after 72 hours in 80 ℃ of water-baths, with preceding dilution desired concn.The used for intravenous injection preparation is that fine powder is concentrated into the extractum shape with the distilled water soak at room temperature after 72 hours in 80 ℃ of water-baths, the time spent press the desired concn distilled water diluting it.

2.1.2 experimental animal: 200～300gWistar kind rat; 2.0～2.5Kg rabbit, the male and female dual-purpose.

2.2 test method and result

2.2.1 whole blood contrast viscosity

Get 10 of rabbit, press the determination of ubbelohde viscometer method, measure every rabbit administration before, the capillary glass tube required time of 0.5ml whole blood in 37 ℃ of water-baths (heparin anti-coagulating 125u/ml) by 8cm, internal diameter 0.55mm.After soothing liver-QI removing food stagnancy ball 10g/kg irritates stomach 60min, pass through the time with same procedure mensuration.Measure the normal saline required time of equal volume simultaneously, ask its ratio promptly to get whole blood contrast viscosity, result such as table 4.

Table 4 soothing liver-QI removing food stagnancy ball is to the influence of rabbit blood viscosity

^*P＜0.001

2.2.2 plasma viscosity

Get 10 of rabbit, press the determination of ubbelohde viscometer method, measure before every rabbit administration and to behind the soothing liver-QI removing food stagnancy ball 10g/kg60min, 1ml blood plasma is by the capillary glass tube required time of long 11cm, internal diameter 0.55mm in 25 ℃ of water-baths.Measure simultaneously with volume normal saline required time, try to achieve ratio, the result is as shown in table 1.

2.2.3 erythrocyte electrophoretic time

Get 10 of rabbit, be divided into 2 groups at random.The normal control group is irritated capacity normal saline such as stomach; Experimental group is irritated stomach soothing liver-QI removing food stagnancy ball 10g/kg.60min before the administration and after the administration gets blood from arteria auricularis, and each 5ml isolates hemocyte and blood plasma, puts erythrocyte in self blood plasma and normal saline, observes and electrophoresis time, the results are shown in Table 5.

Table 5 soothing liver-QI removing food stagnancy ball is to the influence of rabbit erythrocyte electrophoretic time

^*Compare with the normal control group

2.2.4 to thrombotic influence

10 of rat are divided into 2 groups at random.Normal control treated animal intravenous injection equivalent normal saline; Experimental group intravenous injection soothing liver-QI removing food stagnancy ball 10g/kg.Rat pentobarbital sodium 30mg/kg intravenous anesthesia, the circulation of qi promoting cannula, separate right common carotid artery and left external jugular vein, be full of the polyethylene tube of three sections connections with the 50u/ml heparin-saline, No. 4 surgical threads of a long 7cm are put in the pipe stage casing, and a left side outer vein of neck and right common carotid artery are successively inserted in the pipe two ends, behind intravenously administrable or the normal saline, open immediately bulldog clamp makes blood circulation.Herba Clinopodii in behind the 15min takes out silk thread and claims wet weight of thrombus.Calculate thrombosis by following formula.

The results are shown in Table 6, soothing liver-QI removing food stagnancy ball can suppress rat suppository very significantly and form.

Table 6 soothing liver-QI removing food stagnancy ball is to the thrombotic influence of rat experiment

Group	Dosage (g/kg)	Number of animals	Wet weight of thrombus (meansigma methods ± SD mg)	Suppression ratio (%)
Group	Dosage (g/kg)	Number of animals	Wet weight of thrombus (meansigma methods ± SD mg)	Suppression ratio (%)	Normal saline	5	59.14±8.78
Soothing liver-QI removing food stagnancy ball	10.0	5	24.40±6.83	58.74	Normal saline	5	59.14±8.78

2.3 conclusion

Originally having experimental results show that soothing liver-QI removing food stagnancy ball 10g/kg has reduces whole blood viscosity and plasma viscosity ratio significantly, shortens erythrocyte electrophoretic time and suppresses effect such as thrombosis.Thereby can strengthen the fluidity of blood in liver vessel, and improve the liver microcirculation and remove microcirculation disturbance, help the supply of hepatocellular nutrition and oxygen, this recovery to hepatopathy has great importance.Motherland's medical science is thought, hepatic region twinge, gastral cavity rib distension, be owing to depression of liver-QI, the vapour lock stasis, QI-blood circulation does not freely cause the blood stasis state, soothing liver-QI removing food stagnancy ball can play blood circulation and promoting silt, the merit of liver-smoothing, qi-regulating, and its mechanism may have substantial connection with the improvement of its hemorheological property.

Multiple factors such as macromole concentration such as cholesterol, celloglobulin are relevant in the change of whole blood viscosity and plasma viscosity and the quantity of hemocyte, quality, the blood plasma.Wherein erythrocyte cohesion ability in blood has close ties with erythrocyte surface band negative charge of the same race again, and measuring erythrocyte electrophoretic time is the important indicator of reflection erythrocyte charge number.When erythrocyte surface is with negative charge number of the same race to increase, then can strengthen negative charge repulsive interaction of the same race between erythrocyte, make erythrocyte be difficult for assembling, thereby cause blood viscosity to descend.This experiment shows that soothing liver-QI removing food stagnancy ball has the erythrocyte of shortening electrophoresis time in self blood plasma and normal saline, and prompting this product has the effect that increases erythrocyte surface negative charge quantity.

Blood viscosity is influenced by plasma viscosity also, and plasma viscosity depends primarily on the content of celloglobulin, lipid etc.Soothing liver-QI removing food stagnancy ball can make plasma viscosity reduce significantly, also must influence the decline of whole blood viscosity.Influenced which kind of protein content in the blood plasma as for soothing liver-QI removing food stagnancy ball, remained further to be studied.

3 immunological effects

3.1 test material

3.1.1 medicine: soothing liver-QI removing food stagnancy ball fine powder, press desired concn dilution 4 during experiment.Lyophile complement, Lanzhou biological produce lot number: 86004.Lysozyme, fowl egg two factories in Shanghai produce, lot number: 880120.Anti-HBs, Lanzhou biological produce lot number: 87003.

3.1.2 experimental animal: test with 18～22g Kunming kind white mice, male and female dual-purpose.

3.2 test method and result

3.2.1 the influence to organs such as Mouse Liver, spleen and thymus: soothing liver-QI removing food stagnancy ball I group is by quite primary dose 10g/kg, soothing liver-QI removing food stagnancy ball II group is by the quite primary 5g/kg that measures approximately, levamisole is pressed 25mg/kg and is irritated stomach, once a day, continuous 7 days, put to death mice on the 8th day, win liver, spleen, thymus and claim weight in wet base, calculate the organ weights of per 10 gram body weight, the results are shown in Table 7.

The influence (n=7) of table 7 pair Mouse Liver, spleen and thymus

^*P＜0.05 ^**P＜0.01

3.2.2 the influence to serum lysozyme: soothing liver-QI removing food stagnancy ball medication is the same, and cyclophosphamide is pressed the 15mg/kg intramuscular injection.Got blood system from serum on the 8th day, and measured serum lysozyme content, the results are shown in Table 8 with agar diffusion method.

The influence (n=12) of table 8 pair mice serum lysozyme

3.2.3 the influence to the reticuloendothelial system carbon clearance: medication is the same, the 8th day mouse vein injects the india ink 0.2ml of dilution in 1: 8, the immediate record time, in second, 10,25 minute eye socket blood sampling 0.025ml, be added among the 0.1% sodium carbonate liquor 2ml, in spectrophotometer, read the OD value, obtain carbon clearance rate K value, and use formula with the survey of 650nm wavelength

Proofread and correct, the results are shown in Table 9.

The influence (n=7) of table 9 pair mice carbon clearance

3.2.4 to the active influence of the acid nonspecific esterase of peripheral blood lymphocyte: method is the same, the 8th day mice cut tail and gets the blood push jack and do ANAE dyeing, and split under the oily mirror, 100-200 lymphocyte of tail different parts counting write down the reactor, obtain the ANAE positive rate, the results are shown in Table 10.

The influence (n=7) of table 10 pair peripheral blood lymphocyte ANAE reaction

3.2.5 the influence to body endolymph cell: medication was the same, added phytohaemagglutinin (PHA) 6mg/kg in the 2nd day, intramuscular injection, once a day, for three days on end.Test and got the blood push jack on the 5th day, Wright dyeing, split, tail different parts are observed 100 lymphocytes, and record transforms the lymphocyte number of (comprising transitional type), calculates conversion ratio, the results are shown in Table 11.

The influence (n=10) of table 11 pair body endolymph cell

3.2.6 the influence that antagonist generates: administration proxima luce (prox. luc) lumbar injection 5% Sanguis Gallus domesticus ball 0.2ml immune mouse, method is the same, continuous 6 days.Immunity was got blood system from the determination of serum hemolysin level on the 8th day, the results are shown in Table 12.

The influence (n=12) that table 12 pair hemolysin forms

3.2.7 to the inhibition of HBsAg experiment: soothing liver-QI removing food stagnancy extract of bolus (5g/ml) passed doubly dilute, drip in the plate of shallow lake and Ag at the medical blood clotting of " u " type ⁺Patients serum's (electrophoresis was tired 1: 16) effect 2 hours is carried out counter electrophoresis with anti-HBs then routinely, and for inhibitory action (+) is arranged, disappearance person is not unrestraint effect (-), the results are shown in Table 13 with precipitation line disappearance person.

Table 13 pair HBsAg inhibition test

^*Shelved after the use 6 days

3.3 conclusion

This experimental result shows that soothing liver-QI removing food stagnancy ball has the mice of promotion reticuloendothelial system carbon clearance, strengthens monokaryon-macrophage activity, improves peripheral blood lymphocyte ANAE positive rate, increases the T percentage of lymphocyte, and promotes the effect that specific antibody generates.Simultaneously also can promote atrophy of thymus gland, reduce PHA and stimulate the body endolymph cell transformation that is produced, suppress the T lymphocyte activation.Liver, spleen and serum lysozyme etc. then there is not obviously influence.In vitro tests is not seen inhibitory action to HBsAg yet.

The pathology damage reason more complicated of hepatitis be it is generally acknowledged not to be by due to the hepatitis virus direct infection destruction hepatocyte, but relevant with immunoreation.Cause humoral immunization and the cellular immunization that surface of hepatocytes antigen changes at viral infection and all can damage hepatocyte, but think it mainly is, also can suffer from serious acute hepatitis in default of the patient of the r-globulinopenia of antibody by due to the specific cellular immunity.Chronic active hepatitis (CAH) patient that liver tissue injury is more serious, its cellular immunization is particularly evident, and continues to exist with course of disease development.These patients are treated with immunosuppressive drugs such as prednisones, and not only clinical symptoms, liver function index are eased and improve, and also temporarily transfer to normal to cellular immunization (comprising T cell and the K cell immune response) mensuration of liver specificity membrane antigen.Domestic also someone reports that the curative effect of the preceding application class hormonal medicaments of antiviral therapy is more than application person is not good.On the contrary, chronic persistence hepatitis B (CPH-B) patient, its humoral immunization and cellular immunization are all low to the antigenic identification activity of special surface of hepatocytes.Though having, soothing liver-QI removing food stagnancy ball directly do not suppress the HBsAg activity, but can promote monokaryon-macrophage activity, increase the specific antibody generation, improve the periphery blood T lymphocyte ratio, so help the elimination of liver plasma membrane specific antigen, stop the intercellular propagation of HBv, and the recovery of immune response immunologic function when low.Simultaneously, because the T lymphocyte activation is had inhibitory action, so can reduce cellular immunization to hepatocellular attack, the amelioration of inflammation reaction reduces hepatocyte injury.Therefore, soothing liver-QI removing food stagnancy ball may be a kind of good immunomodulator, and rational Application then helps the hepatopathy recovery from illness.

Test example two: medicine soothing liver-QI removing food stagnancy ball animal acute toxicity test of the present invention

1 test material

1.1 medicine: soothing liver-QI removing food stagnancy ball is done following extraction respectively and is handled:

1.1.1 injection for intravenous reagent: soothing liver-QI removing food stagnancy ball fine powder floods with the distilled water room temperature, each 72 hours, flood secondary altogether, and first and second time flooded with the distilled water in 5,3 times of crude drug amounts respectively.Impregnation liquid is filtered merging, and it is standby to be concentrated into 2.5g/ml (amounting to crude drug total amount meter) in 80 ℃ of water-baths, faces the time spent by the desired concn distilled water diluting.

1.1.2 supply oral reagent: soothing liver-QI removing food stagnancy ball fine powder floods 2 times with 45% analytical pure ethanol room temperature, each 72 hours, first and second time is respectively with in the alcohol dipping of 5,3 times of crude drug amounts, impregnation liquid is filtered merging, it is standby to be concentrated into 15g/ml (amounting to crude drug total amount meter) in 80 ℃ of water-baths, faces the time spent and dilutes by desired concn.

1.2 experimental animal: experiment is provided by Lanzhou Institute of Biological Products with 18～22g Kunming kind closed colony white mice.

2 test methods and result

2.1 pick out healthy 20 of the experiment mices (male and female half and half) of hindering body weight 19 ± 1g that do not have,, one by one mice carried out the tail vein injection administration with sequential method by the reagent of the intravenously administrable volume dilution sequential method requirement dosage of 0.2ml/10g body weight.The death of each experiment mice distributes with survival in the observed and recorded 5 minutes.With gained as a result the substitution formula calculate.

Experimental result shows, the LD of mouse mainline ₅₀=25.7/kg (amounting to crude drug total amount meter) sees table 14 for details.

Purgation acute toxicity testing table as a result on the table 14 mouse mainline soothing liver-QI removing food stagnancy ball

"+" dead "-" survival

Hinder body weight 19 ± 1g experiment mice 2.2 select healthy nothing, with experiment mice fasting 12 hours (can't help water).By the body weight random packet, 10 every group, male and female half and half are divided into three groups.By mice 0.4ml/10g body weight administration volume conversion dilution reagent for oral use, give three groups of mices respectively by simplifying the probit method requirement, be subjected to the reagent thing, observe the reaction of animals situation after the administration immediately.Observed 7 days continuously, the record death toll is obtained mortality rate, and substitution three dose counting formula are asked the oral LD of this medicine mice ₅₀95% fiducial limit.

The result shows the LD of this medicine ₅₀The 95% credible 271.14-723.10g/kg of being limited to (amounting to medicine total amount meter) see table 15 for details.

The oral soothing liver-QI removing food stagnancy of table 15 mice ball acute toxicity testing is table as a result

Y meansigma methods=4.14 W summation=14.4

3 conclusions

The oral LD of this medicine ₅₀Value belongs to harmless substantially scope from the acute hierarchical table of chemical substance.The possible lethal dose of human oral is greater than 1200 grams.

From oral this medicine experimental result of white mice 240/kg mortality rate is zero.Do the margin of safety inspection with this, try to achieve the mouse tolerance dose multiple and be:

Mice tolerance safety multiple=1177

(generally requiring multiple is to be safety at 100 o'clock)

Directly feed honeyed pill after two weeks, administration group and natural death rate difference nonsignificance (P＞0.05) for mice.And the mice activity freely.

From The above results as seen.Clinical take safe and reliable.

Test example three: medicine soothing liver-QI removing food stagnancy ball long-term toxicity test for animals of the present invention

1 test material

1.1 medicine: soothing liver-QI removing food stagnancy ball fine powder by, with 45% medicinal alcohol normal temperature dipping 72 hours, filter.Medicinal residues are used 45% medicinal alcohol twice at normal temperatures, flood first and second time time to be respectively 48,24 hours, impregnation liquid are filtered merge, and being concentrated in 80 ℃ of water-baths does not have alcohol.During experiment, press the desired concn dilution with distilled water.

1.2 experimental animal: body weight 100 ± 20gWistar kind healthy rat in six ages in week is provided by Animal Experimental Study chamber, institute of oncology, Gansu Province.

2 test methods and result

2.1 method

With indoor feeding one week of experimental rat at 20 ± 2 ℃, the physiological and biochemical index that the determination experiment chamber is observed once.Physiological and biochemical index comprises hemogram (RBC, WBC, Nb, OC), and liver function (icteric index, zinc sulfate turbidity, SCPT), kidney merit (blood urea nitrogen) are selected 80 of the normal animals of every index.Be divided into 4 groups by the body weight stratified random, 20 every group, male and female half and half are divided four groups of high, medium and low, blanks.The high dose group dosage is 33g/kg/d (being equivalent to 100 times of the primary about dosage of clinical human), middle dosage group is 16.5g/kg/d (being equivalent to 50 times of clinical human crude drug in whole dosage), low dose group is 8.25g/kg/d (being equivalent to 25 times of clinical human crude drug in whole dosage), the blank group gives to irritate stomach equal volume normal saline with the administration group, once a day, continuous 90 days, sacrificed by exsanguination after the drug withdrawal, get blood and make the hemogram biochemical indicator, corpse is done the pathology inspection.

Other observation index: general behavior activity, body weight, feces etc.Per 10 days of body weight claims once, in time adjusts dosage, and the organ that pathological anatomy is checked is had the inclination, liver, spleen lung, kidney, thymus, stomach, adrenal gland, carries out overview, draws materials, fixes, cuts into slices, dyes and do microscopic examination.

2.2 result

2.2.1 general situation

Rat vegetative activity between each administration group and the normal saline blank group is all normal, and hair color is glossy and be close to body, and feces is normal, does not have unusual sign such as diarrhoea, loose stool.Dynamic observing of body weight shows no significant difference between four groups.See table 16 for details.

The oral rat long term toxicity of table 16 soothing liver-QI removing food stagnancy ball body weight change table

2.2.2 blood and biochemical indicator are observed:

Between each administration group and the normal saline blank group, the rat hemogram is before liver function (SCPT, ZnTT, II), renal function (UN) administration, during the administration 45 days, administration was after 90 days, every index, all belong to normal range, mathematical statistics, also no significant difference between each group.Above-mentioned leading indicator sees Table 17, table 18.

The oral rat long term toxicity of table 17 soothing liver-QI removing food stagnancy ball hemogram change list (meansigma methods ± SD)

The oral rat long term toxicity of table 18 soothing liver-QI removing food stagnancy ball changes of biochemical indexes table (meansigma methods ± SD)

2.2.3 pathologic finding

The relative weight of each important organ of the oral soothing liver-QI removing food stagnancy of rat ball is learned processing by statistics, proves no significant difference between four groups.See table 19 for details.

Table 19 soothing liver-QI removing food stagnancy ball long term toxicity test pathology test result (meansigma methods ± SD)

3 conclusions

This experiment is according to Ministry of Health of the People's Republic of China's " provisions for new drugs approval " " about the supplementary provisions and the explanation of Chinese medicine problem " and the evaluating suggestion of Ministry of Public Health committee of drug evaluation and research design.

Body weight, feces and general behavior activity that the oral soothing liver-QI removing food stagnancy of rat ball long term toxicity test is observed; Many indexs such as hemogram, hepatic and renal function and pathologic finding each vitals, especially thymus there is no evident difference between administration group and matched group.Dosage is up to 100 times of clinical consumptions, and continuous 90 days, all do not demonstrate the drug toxicity reaction symptom, can think that soothing liver-QI removing food stagnancy ball reality is nontoxic.

Test example four: medicine soothing liver-QI removing food stagnancy ball clinical observation on the therapeutic effect test of the present invention

1 clinical data

1.1 physical data

403 routine patients all are diagnosed as chronic hepatitis B through clinical, lab testing, have got rid of chronic diseases such as the heart, lung, kidney.403 routine patients are divided into two groups according to randomization, and 303 examples are organized in treatment, matched group 100 examples.Wherein male 293 examples, women 110 examples; The oldest person 72 years old, reckling 4 years old, 34 years old mean age; The elder of the course of disease 22 years, the shortest person half a year, average course of disease 11.25.Situations such as the age-sex of two groups of cases, the state of an illness and the course of disease have comparability.

Wherein treatment group is 303 examples.Matched group is 100 examples.Be 15 months observing time.

1.2 traditional Chinese medical science typing and Western medicine diagnose

Traditional Chinese medical science typing: according to " the clinical research guideline of treatment by Chinese herbs viral hepatitis " promulgated by the ministries or commissions of the Central Government, the Chinese medical discrimination typing in " viral hepatitis is prevented and treated scheme " is worked out in infectious disease academic meeting in the whole nation, Zhengzhou in November nineteen eighty-three, primary disease is divided into six types, damp and hot type 72 examples of not using up of wherein treatment group, liver-depression and spleen-insufficiency type 114 examples, liver-kidney yin deficiency 29 examples, yang deficiency of spleen and stomache 11 examples, type of deficiency of both QI and YIN 40 examples, qi stagnation and blood stasis type 37 examples, damp and hot type 21 examples, liver-depression and spleen-insufficiency type 47 examples do not use up of matched group, liver-kidney yin deficiency 11 examples, yang deficiency of spleen and stomache 4 examples, type of deficiency of both QI and YIN 5 examples, qi stagnation and blood stasis type 12 examples.

Western medicine diagnose: work out " viral hepatitis is prevented and treated scheme " as diagnosis basis according to " the clinical research guideline of treatment by Chinese herbs viral hepatitis " promulgated by the ministries or commissions of the Central Government, the academic meeting of the whole nation, Zhengzhou in November nineteen eighty-three infectious disease.Wherein treatment group chronic persistent hepatitis 157 examples, chronic active hepatitis 71 examples, liver cirrhosis due to hbv 43 examples, hepatitis B virus carriers 32 examples.Matched group chronic persistent hepatitis 59 examples, chronic active hepatitis 30 examples, liver cirrhosis due to hbv 11 examples.

1.3 Therapeutic Method

1.3.1 grouping and Therapeutic Method

403 examples are divided into treatment group and matched group at random.The treatment group is taken soothing liver-QI removing food stagnancy ball, and three times on the one, each 1-2 ball, warm water delivery service after meal, matched group is taken " academic conference of national viral hepatitis special topic " and is recommended effective medicine ease pill, and usage is the same, takes double-blind method.Two groups all with around be a course of treatment.Serve on three courses of treatment, carry out the inspection of every lab index after per course of treatment, and the record symptom, the variation of sign in addition, is carried out treatment in long term (half a year) after finishing soothing liver-QI removing food stagnancy ball course of treatment and is followed up a case by regular visits to (8 months) observation taking 53 routine chronic hepatitis B patients.

The period in a medicine diet is greasy, raw and cold, maror, absolute alleviating alcohol addiction.

1.3.2 MAIN OUTCOME MEASURES:

Symptom, sign, doctor trained in Western medicine inspection (liver function test: thymol turbidity test, glutamate pyruvate transaminase; Serum albumin; The liver ultrasound investigation, the hepatitis b virus marker inspection).

1.4 curative effect is judged:

According to the clinical research guideline of viral hepatitis " in treat approximately " promulgated by the ministries or commissions of the Central Government, the academic meeting of the whole nation, Zhengzhou in November nineteen eighty-three infectious disease, and with reference to the internal medicine hepatopathy meeting of the whole nation, Tianjin in 1991, in conjunction with the side of offering people clinical experience and ordering for many years.

1.4.1 clinical basic healing:

1, clinical card marquis disappears;

2, hepatosplenomegaly is stablized no change or retraction, and the hepatic region does not have the pain of tunking;

3, liver function test recovers normal;

4, the hepatitis B person requires HBV-N to duplicate the cloudy commentaries on classics of index, and HBsAg can be positive;

5, above every stable 6-12 month person.

1.4.2 produce effects:

1, clinical symptom disappearance is more than half or take a turn for the better and to account for more than 2/3;

2, the stable or retraction of hepatosplenomegaly, the hepatic region does not have tenderness or kowtows pain;

3, the normal or slight abnormality of liver function recovery;

4, hepatitis B requires HBV-N to duplicate index cloudy a commentaries on classics, but HBsAg still can be positive.

1.4.3 effectively:

1, clinical symptom disappearance is more than 1/3 or take a turn for the better and to account for more than 1/2;

2, hepatosplenomegaly is stablized constant or retraction, and the hepatic region does not have percussion pain;

3, the more former inspection value of liver function test descends more than 1/2;

4, hepatitis B requires HBV-N to duplicate index to descend to some extent, but HBsAg still can be positive.

1.4.4 it is invalid: as not reach These parameters person.

2 results

2.1 two groups of Chinese medical discrimination typing efficacy results see table 20 for details.

Table 20 Chinese medical discrimination typing efficacy analysis table

The clinical cure rate of treatment group as can be seen from the table is 30.03%, and produce effects 36.63% takes a turn for the better 26.07%, and total effective rate is 92.74%; And the matched group clinical cure rate is 6%, and produce effects 20% takes a turn for the better 24%, and is invalid 50%, total effective rate be 50%, two group of curative effect relatively, learn by statistics and handle difference highly significant meaning (P=0.001) is arranged.Liver-depression and spleen-insufficiency type between two groups again, liver-kidney yin deficiency has significance meaning (preceding amphitypy P value is 0.025＜P＜0.05, and type of deficiency of both QI and YIN is 0.005＜P＜0.01) between type of deficiency of both QI and YIN difference.

The treatment group is learned processing by statistics, find damp and hot to the greatest extent between type and liver-kidney yin deficiency, yang deficiency of spleen and stomache, type of deficiency of both QI and YIN, the qi stagnation and blood stasis type difference significance meaning (the P value is respectively 0.002＜P＜0.005, P＜0.001,0.001＜P＜0.002, P＜0.001) is all arranged; Liver-depression and spleen-insufficiency type and liver-kidney yin deficiency, yang deficiency of spleen and stomache, type of deficiency of both QI and YIN, qi stagnation and blood stasis type differences also have highly significant (the P value is P＜0.001); Liver-kidney yin deficiency and yang deficiency of spleen and stomache differences have highly significant meaning (P＜0.001); Yang deficiency of spleen and stomache and type of deficiency of both QI and YIN, qi stagnation and blood stasis type differences have highly significant meaning (the P value is P＜0.001); Equal zero difference between surplus each group.To the greatest extent type and liver-depression and spleen-insufficiency type curative effect are not better to damp and hot for treatment group as seen from the table, and type of deficiency of both QI and YIN and qi stagnation and blood stasis type take second place, and liver-kidney yin deficiency and yang deficiency of spleen and stomache more take second place.

2.2 two groups of Western medicine diagnose efficacy analysis see table 21 for details.

Table 21 liang group Western medicine diagnose efficacy analysis

As can be seen from the table, two groups cure rate, obvious effective rate, effective percentage, inefficiency and total effective rate are with traditional Chinese medical science typing efficacy analysis.The chronic persistent hepatitis of treatment group and matched group, chronic active hepatitis, liver cirrhosis due to hbv differences have highly significant meaning (the P value is P＜0.001).

In the treatment group again, learn to handle by statistics, find that then soothing liver-QI removing food stagnancy ball is better to chronic persistent hepatitis,, to virus carrier, chronic active hepatitis and liver cirrhosis due to hbv (chronic persistent hepatitis and chronic active hepatitis: 0.002＜P＜0.005 of then taking second place; Chronic persistent hepatitis and liver cirrhosis due to hbv P＜0.001, equal zero difference between all the other each groups).

2.3 two groups of variations for the treatment of front and back symptom, sign; See table 22 for details.

The variation of symptom, sign before and after the table 22 liang group treatment

As can be seen from the table, soothing liver-QI removing food stagnancy ball also has better action to improving clinical symptoms and sign, such as hypochondriac pain, the side of body down long-pending piece, gastral cavity abdomen go up painful etc. and all the significance meaning to be arranged with matched group difference, see for details in the table.

2.4 two groups of variations that treatment back Western medicine diagnose is checked see table 23 for details.

The variation of table 23 liang group treatment back laboratory examination

^*P＜0.001

From showing as can be known soothing liver-QI removing food stagnancy ball to improving the turbid test of Moschus moschiferous, glutamate pyruvate transaminase, A/G is inverted all better action, and learning by statistics to handle all has significant difference (the P value is P＜0.001) with matched group.

2.5 after two groups of treatments, HBV-N conversion situation relatively; See table 24 for details.

Table 24 a liang group treatment back HBV-N transforms situation

Grouping	HBsAg	Anti--HBs	HBeAg	Anti--HBe	Anti--HBc
Grouping	HBsAg	Anti--HBs	HBeAg	Anti--HBe	Anti--HBc	The treatment group	41/263	17/234	37/82	36/85	13/242
Matched group	6/100	4/100	5/78	5/80	5/91	The treatment group	41/263	17/234	37/82	36/85	13/242

Treatment group HBsAg, HBeAg, anti--HBe conversion ratio all are higher than matched group (P＜0.001), and do not have statistical significance between anti--HBs, anti--two groups of HBc.Illustrate that soothing liver-QI removing food stagnancy ball all has better action to the conversion of HBsAg, HBeAg, anti--HBe.

2.6 two groups of different course are to the comparison of chronic viral hepatitis B curative effect:

Two groups of different course find that relatively treatment group and matched group difference all have significance meaning (P＜0.001), see table 25 for details.

Table 25 liang group different course is to the overall merit of chronic hepatitis B curative effect

^*P＜0.001

2.7 situation is followed up a case by regular visits in treatment at a specified future date:

We are from the chronic hepatitis B patients that hospital accepts for medical treatment, 53 routine patients are continued to treat 3 courses of treatment, the result cures 40 examples, produce effects 9 examples, effective 4 examples, total effective rate is 100%, treatment was followed up a case by regular visits to 8 months after finishing, 53 routine patient symptoms disappear as a result, and it is normal stable that hepatopathy is recovered fully, and HBVN also has improvement to a certain degree; Wherein the moon changes 1 example in HBsAg8 month, and negative conversion rate is 2.7%; Anti-HBs does not have 1 example changes sun; Cloudy 3 examples of changeing of HBeAg, negative conversion rate is 27.27%, and anti-HBe sun changes 7 examples, and positive rate of rotation is 25.93%, cloudy 1 example of changeing of anti-HBc, negative conversion rate is 2.7%, does not have 1 example and knock-on occurs.

3 conclusions

In order further to prove this medicine reliability and effective degree, we study this medicine in strict accordance with the clinical medicine design, last 15 months, found that soothing liver-QI removing food stagnancy pill for curing hepatitis B clinical cure rate is 30.03%, produce effects 36.63%, take a turn for the better 26.07%, invalid 7.26%, total effective rate reaches 92.74%.And type and liver-depression and spleen-insufficiency type curative effect are not better to the greatest extent to hepatitis B traditional Chinese medical science typing damp and hot to find soothing liver-QI removing food stagnancy ball, and type of deficiency of both QI and YIN and qi stagnation and blood stasis type then take second place, and soothing liver-QI YIN-deficiency type and yang deficiency of spleen and stomache more take second place.Better to the chronic liver effect of moving in the doctor trained in Western medicine typing, and to chronic active hepatitis, liver cirrhosis due to hbv and hepatitis B virus carriers then take second place.

This research still points out soothing liver-QI removing food stagnancy ball to improving clinical symptoms, and sign and laboratory examination abnormal index all have better action to normal conversion.

Research finds that also soothing liver-QI removing food stagnancy ball has better action to the conversion of HBsAg, the anti-HBe of HBeAg, wherein the HBsAg negative conversion rate is 15.59%, the HBeAg negative conversion rate is 45.12%, and it is 42.35% that anti-HBe changes positive rate, and this shows that soothing liver-QI removing food stagnancy ball has the obvious suppression effect to hepatitis B replication.

In the relative analysis of using soothing liver-QI removing food stagnancy ball different course, find that itself and matched group per course of treatment of difference all have significance meaning (P＜0.001), and its curative effect prolongs in time and improves.

This research has been carried out trimestral treatment again to 53 routine hepatitis B patients, and the tracing study result controls 40 examples, produce effects 9 examples, and effective 4 examples, total effective rate 100%, and, show that the late result of soothing liver-QI removing food stagnancy ball is better to the better action of having killed of hepatitis B virus duplication.

53 examples are followed up a case by regular visits in this research, and patient symptom disappears, and liver function is recovered fully and be stable.The HBeAg negative conversion rate is during from drug withdrawal 63.33%, and to drug withdrawal 27.27% in the time of 8 months, maintenance will continue cloudy cloudy commentaries on classics that change and continue, anti-HBe sun rate of rotation is during from drug withdrawal 32.50%, to drug withdrawal 25.93% in the time of 8 months, keeping continuing sun changes, and further having showed soothing liver-QI removing food stagnancy ball has late result preferably.

In a word, soothing liver-QI removing food stagnancy ball has therapeutical effect preferably to chronic hepatitis B, and its curative effect prolongs in time and improve, in the recent period and long-term effect all comparatively satisfied.Modern pharmacological research confirms that also this medicine not only can alleviate hepatocellular degeneration, necrosis, and effects such as the good jaundice that disappears, function of gallbladder promoting are arranged, and also significant to preventing cirrhotic generation, may be a kind of good immunomodulator.Therefore, chronic hepatitis B patient can select for use soothing liver-QI removing food stagnancy ball to treat clinically.In this medicine clinical research process, according to each medical institutions provide objective data, treat for many years in conjunction with the clinician that hepatopathy is known from experience and patient's reflection, we think that " soothing liver-QI removing food stagnancy ball " take safety, curative effect is reliable, does not find untoward reaction, and clinical effectiveness is better than other same veriety.

The specific embodiment

Embodiment 1

Take by weighing by following proportioning:

Herba Artemisiae Scopariae 235g Radix Bupleuri 277g Radix Angelicae Sinensis 39g Radix Paeoniae Alba 115g

Radix Salviae Miltiorrhizae 475g Radix Curcumae 39g Rhizoma Corydalis 277g rhizoma sparganic 39g

Rhizoma Curcumae 39g Rhizoma Cyperi 277g Fructus Toosendan 39g Radix Codonopsis 396g

Rhizoma Atractylodis Macrocephalae 39g Radix Astragali 712g Poria 475g Fructus Aurantii Immaturus 39g

Fructus Amomi 39g Semen Arecae 113g Lignum Aquilariae Resinatum 19g Radix Glycyrrhizae 277g

Medicine of the present invention can obtain big honeyed pills by following method:

1. get Radix Bupleuri, Rhizoma Corydalis, Rhizoma Curcumae, Rhizoma Cyperi and carry out processed according to the vinegar system method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one);

Get rhizoma sparganic and carry out processed according to the concocting method of regulation under this kind item of Chinese Pharmacopoeia (2005 editions an one);

Get the Radix Paeoniae Alba, Fructus Toosendan according to this kind item of Chinese Pharmacopoeia (2005 editions an one) down the concocting method of regulation carry out processed;

Get the Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus carries out processed according to the parched with bran method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one);

Get Radix Codonopsis, the Radix Astragali, Radix Glycyrrhizae and carry out processed according to the processed with honey method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one).

2. get Herba Artemisiae Scopariae, Radix Bupleuri (vinegar system), Radix Angelicae Sinensis, the Radix Paeoniae Alba (stir-fry), Radix Salviae Miltiorrhizae, Radix Curcumae, Rhizoma Corydalis (vinegar system), rhizoma sparganic (system), Rhizoma Curcumae (vinegar system), Rhizoma Cyperi (vinegar system), Fructus Toosendan (stir-fry), Radix Codonopsis (processed with honey), the Rhizoma Atractylodis Macrocephalae (parched with bran), the Radix Astragali (processed with honey), Poria, Fructus Aurantii Immaturus (parched with bran), Fructus Amomi, Semen Arecae, Lignum Aquilariae Resinatum, Radix Glycyrrhizae (processed with honey) 20 flavors, be ground into fine powder, sieve mixing.

3. get above-mentioned fine powder, every 100g adds refined honey 130g～150g, makes big honeyed pills.

Embodiment 2

Take by weighing by following proportioning:

Herba Artemisiae Scopariae 450g Radix Bupleuri 135g Radix Angelicae Sinensis 135g Radix Paeoniae Alba 300g

Radix Salviae Miltiorrhizae 300g Radix Curcumae 225g Rhizoma Corydalis 135g rhizoma sparganic 135g

Rhizoma Curcumae 135g Rhizoma Cyperi 135g Fructus Toosendan 135g Radix Codonopsis 225g

Rhizoma Atractylodis Macrocephalae 135g Radix Astragali 450g Poria 300g Fructus Aurantii Immaturus 135g

Fructus Amomi 135g Semen Arecae 135g Lignum Aquilariae Resinatum 90g Radix Glycyrrhizae 135g

Production method: with embodiment 1 production method.

Embodiment 3

Take by weighing by following proportioning:

Herba Artemisiae Scopariae 290g Radix Bupleuri 39g Radix Angelicae Sinensis 277g Radix Paeoniae Alba 200g

Radix Salviae Miltiorrhizae 115g Radix Curcumae 396g Rhizoma Corydalis 39g rhizoma sparganic 277g

Rhizoma Curcumae 277g Rhizoma Cyperi 39g Fructus Toosendan 277g Radix Codonopsis 39g

Rhizoma Atractylodis Macrocephalae 277g Radix Astragali 235g Poria 115g Fructus Aurantii Immaturus 277g

Fructus Amomi 277g Semen Arecae 277g Lignum Aquilariae Resinatum 198g Radix Glycyrrhizae 39g

Production method: with embodiment 1 production method.

Embodiment 4

Take by weighing by following proportioning:

Herba Artemisiae Scopariae 712g Radix Bupleuri 100g Radix Angelicae Sinensis 100g Radix Paeoniae Alba 475g

Radix Salviae Miltiorrhizae 200g Radix Curcumae 200g Rhizoma Corydalis 100g rhizoma sparganic 135g

Rhizoma Curcumae 135g Rhizoma Cyperi 170g Fructus Toosendan 100g Radix Codonopsis 260g

Rhizoma Atractylodis Macrocephalae 100g Radix Astragali 533g Poria 150g Fructus Aurantii Immaturus 100g

Fructus Amomi 100g Semen Arecae 39g Lignum Aquilariae Resinatum 151g Radix Glycyrrhizae 100g

Production method: with embodiment 1 production method.

Embodiment 5

Take by weighing by following proportioning:

Medicine of the present invention can obtain water-honeyed pill by following method:

3. get above-mentioned fine powder, every 100g adds about 15ml water with refined honey 10g～15g, and mixing is made water-honeyed pill.

4. get above-mentioned wet ball, drying, coating, polishing, packing gets finished product.

Embodiment 6

Take by weighing by following proportioning:

Herba Artemisiae Scopariae 90g Radix Bupleuri 27g Radix Angelicae Sinensis 27g Radix Paeoniae Alba 60g

Radix Salviae Miltiorrhizae 60g Radix Curcumae 45g Rhizoma Corydalis 27g rhizoma sparganic 27g

Rhizoma Curcumae 27g Rhizoma Cyperi 27g Fructus Toosendan 27g Radix Codonopsis 45g

Rhizoma Atractylodis Macrocephalae 27g Radix Astragali 90g Poria 60g Fructus Aurantii Immaturus 27g

Fructus Amomi 27g Semen Arecae 27g Lignum Aquilariae Resinatum 18g Radix Glycyrrhizae 27g

Medicine of the present invention can obtain tablet by following method:

1. get Radix Angelicae Sinensis, Semen Arecae, Lignum Aquilariae Resinatum, mixing, the system fine powder, standby.

2. get Radix Bupleuri, Rhizoma Corydalis, Rhizoma Curcumae, Rhizoma Cyperi and carry out processed according to the vinegar system method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one);

3. get Herba Artemisiae Scopariae, Radix Bupleuri (vinegar system), the Radix Paeoniae Alba (stir-fry), Radix Salviae Miltiorrhizae, Radix Curcumae, Rhizoma Corydalis (vinegar system), rhizoma sparganic (system), Rhizoma Curcumae (vinegar system), Rhizoma Cyperi (vinegar system), Fructus Toosendan (stir-fry), Radix Codonopsis (processed with honey), the Rhizoma Atractylodis Macrocephalae (parched with bran), the Radix Astragali (processed with honey), Poria, Fructus Aurantii Immaturus (parched with bran), Fructus Amomi, Radix Glycyrrhizae (processed with honey) 17 flavors, decoct with water twice, for the first time add 8 times of amounts of water, decocted 2 hours; For the second time add 6 times of amounts of water, decocted 1 hour, merge decocting liquid, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.30 (20 ℃), drying, and the system fine powder, standby.

4. get above-mentioned two kinds of fine powders, add soluble starch 22g, mixing with 80% ethanol 200ml moistening, is granulated, and is lower than 60 ℃ of dryings.

5. get dried particles, add carboxymethyl starch sodium 15g, magnesium stearate 1g, mixing is pressed into 1000, sugar coating or film-coat, promptly.

Embodiment 7

Take by weighing by following proportioning:

With embodiment 6 proportionings.

Medicine of the present invention can obtain capsule by following method:

1. with 3 steps operation before embodiment 6 production methods.

2. get above-mentioned two kinds of fine powders, add dextrin 48g, mixing with 80% ethanol 200ml moistening, is granulated, and is lower than 60 ℃ of dryings.

3. get dried particles, load capsule, make 1000, promptly.

Embodiment 8

Take by weighing by following proportioning:

With embodiment 6 proportionings.

Medicine of the present invention can obtain mixture by following method:

2. get Herba Artemisiae Scopariae, Radix Bupleuri (vinegar system), Radix Angelicae Sinensis, the Radix Paeoniae Alba (stir-fry), Radix Salviae Miltiorrhizae, Radix Curcumae, Rhizoma Corydalis (vinegar system), rhizoma sparganic (system), Rhizoma Curcumae (vinegar system), Rhizoma Cyperi (vinegar system), Fructus Toosendan (stir-fry), Radix Codonopsis (processed with honey), the Rhizoma Atractylodis Macrocephalae (parched with bran), the Radix Astragali (processed with honey), Poria, Fructus Aurantii Immaturus (parched with bran), Fructus Amomi, Semen Arecae, Lignum Aquilariae Resinatum, Radix Glycyrrhizae (processed with honey) 20 flavors, decoct with water twice, for the first time add 8 times of amounts of water, decocted 2 hours; For the second time add 6 times of amounts of water, decocted 1 hour, merge medicinal liquid, being evaporated to coherent density is the clear paste of 1.10 (20 ℃).

3. get above-mentioned clear paste, left standstill 24 hours, filter, being evaporated to coherent density is the clear paste of 1.12 (20 ℃), and standing over night filters, and adds water to 2200ml, stir evenly, and embedding, sterilization promptly gets mixture.

Embodiment 9

Take by weighing by following proportioning:

With embodiment 6 proportionings.

Medicine of the present invention can obtain granule by following method:

2. get Herba Artemisiae Scopariae, Radix Bupleuri (vinegar system), Radix Angelicae Sinensis, the Radix Paeoniae Alba (stir-fry), Radix Salviae Miltiorrhizae, Radix Curcumae, Rhizoma Corydalis (vinegar system), rhizoma sparganic (system), Rhizoma Curcumae (vinegar system), Rhizoma Cyperi (vinegar system), Fructus Toosendan (stir-fry), Radix Codonopsis (processed with honey), the Rhizoma Atractylodis Macrocephalae (parched with bran), the Radix Astragali (processed with honey), Poria, Fructus Aurantii Immaturus (parched with bran), Fructus Amomi, Semen Arecae, Lignum Aquilariae Resinatum, Radix Glycyrrhizae (processed with honey) 20 flavors, decoct with water twice, for the first time add 8 times of amounts of water, decocted 2 hours; For the second time add 6 times of amounts of water, decocted 1 hour, merge medicinal liquid, being evaporated to coherent density is the thick paste of 1.30 (20 ℃).

3. get above-mentioned thick paste, add dextrin 242g, mixing is granulated, and is lower than 60 ℃ of dryings.

4. get dried particles, adorn 220 bags, promptly.

Claims

1, a kind of medicine that is used for the treatment of chronic hepatitis B is characterized in that it is the medicament of being made by following weight percentages: Herba Artemisiae Scopariae 6～18%, Radix Bupleuri 1～7%, Radix Angelicae Sinensis 1～7%, the Radix Paeoniae Alba 3～12%, Radix Salviae Miltiorrhizae 3～12%, Radix Curcumae 1～10%, Rhizoma Corydalis 1～7%, rhizoma sparganic 1～7%, Rhizoma Curcumae 1～7%, Rhizoma Cyperi 1～7%, Fructus Toosendan 1～7%, Radix Codonopsis 1～10%, the Rhizoma Atractylodis Macrocephalae 1～7%, the Radix Astragali 6～18%, Poria 3～12%, Fructus Aurantii Immaturus 1～7%, Fructus Amomi 1～7%, Semen Arecae 1～7%, Lignum Aquilariae Resinatum 0.5～5%, Radix Glycyrrhizae 1～7%.

2, according to the described a kind of medicine that is used for the treatment of chronic hepatitis B of claim 1, it is characterized in that the weight percent content of described each raw material is: Herba Artemisiae Scopariae 11.36%, Radix Bupleuri 3.41%, Radix Angelicae Sinensis 3.41%, the Radix Paeoniae Alba 7.58%, Radix Salviae Miltiorrhizae 7.58%, Radix Curcumae 5.68%, Rhizoma Corydalis 3.41%, rhizoma sparganic 3.41%, Rhizoma Curcumae 3.41%, Rhizoma Cyperi 3.41%, Fructus Toosendan 3.41%, Radix Codonopsis 5.68%, the Rhizoma Atractylodis Macrocephalae 3.41%, the Radix Astragali 11.36%, Poria 7.58%, Fructus Aurantii Immaturus 3.41%, Fructus Amomi 3.41%, Semen Arecae 3.41%, Lignum Aquilariae Resinatum 2.27%, Radix Glycyrrhizae 3.41%.

3, according to claim 1 or 2 described a kind of medicines that are used for the treatment of chronic hepatitis B, it is characterized in that described Radix Bupleuri, Rhizoma Corydalis, Rhizoma Curcumae, Rhizoma Cyperi according to 2005 editions one one of Chinese Pharmacopoeia, the vinegar system method under this kind item in the concocting method is carried out processed; Rhizoma sparganic is according to 2005 editions one one of Chinese Pharmacopoeia, and this kind item concocting method of regulation down carries out processed; The Radix Paeoniae Alba, Fructus Toosendan are according to 2005 editions one one of Chinese Pharmacopoeia, and this kind item concocting method of regulation down carries out processed; The Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus are according to 2005 editions one one of Chinese Pharmacopoeia, and the parched with bran method under this kind item in the concocting method is carried out processed; Radix Codonopsis, the Radix Astragali, Radix Glycyrrhizae are according to 2005 editions one one of Chinese Pharmacopoeia, and the processed with honey method under this kind item in the concocting method is carried out processed.

4,, it is characterized in that described medicament is the above a regular dosage form of pharmaceutics according to claim 1 or 2 described a kind of medicines that are used for the treatment of chronic hepatitis B.

5,, it is characterized in that described medicament is the above a routine dosage form for oral administration of pharmaceutics according to the described a kind of medicine that is used for the treatment of chronic hepatitis B of claim 4.

6,, it is characterized in that described medicament is big honeyed pills agent, water-honeyed pill, tablet, capsule, mixture, granule according to the described a kind of medicine that is used for the treatment of chronic hepatitis B of claim 5.