CN1559493A - Medicine for treating hapatitis - Google Patents

Abstract

A Chinese medicine for treating hepatitides is prepared from 6 Chinese-medicinal materials including bupleurum root, oriental wormwood, isatis root, schisandra fruit, etc.

Description

A kind of medicine for the treatment of hepatitis

Technical field

The present invention relates to a kind of Chinese medicine preparation, promptly a kind of medicine for the treatment of hepatitis.

Background technology

In prior art, in recent years hepatitis be clinically commonly encountered diseases, frequently-occurring disease, to relate to patient group many, and report is arranged, China's hepatitis reaches 10% of population.The medicine of treatment hepatitis, also kind is more, and " liver-protecting tablet " of strong sales is drug of first choice on the market, but also has the not good enough deficiency of curative effect.By retrieval, the patent application of treatment hepatitis is also a lot, mandate discloses the patent of invention that a kind of name is called " a kind of medicine for the treatment of hepatitis B " as Chinese invention patent description CN1067267C, its raw material consists of Radix Salviae Miltiorrhizae, Poria, Carapax Trionycis, the Radix Astragali, Herba Artemisiae Scopariae, Radix Isatidis, Radix Angelicae Sinensis, Radix Codonopsis, Fructus Schisandrae Chinensis, Rhizoma Polygoni Cuspidati, Pericarpium Citri Reticulatae, Ganoderma, Radix Bupleuri, Radix Glycyrrhizae, Radix Curcumae, Herba Patriniae etc., and its shortcoming is that the prescription flavour of a drug are many, unreasonable, toxicity is big, cost is high, curative effect is general.

Summary of the invention

The present invention seeks to provides a kind of prescription science, with low cost at above-mentioned deficiency, and curative effect is treated the medicine of hepatitis more significantly.

Technical solution of the present invention is: it makes medicament by the raw material of following weight the medicine of treatment hepatitis: Radix Bupleuri 240-360 gram, Herba Artemisiae Scopariae 240-360 gram, Radix Isatidis 240-360 gram, Fructus Schisandrae Chinensis 250-380 gram, Pulvis Fellis Suis 15-25 gram, krestin 15-25 gram.Be mixed and made into tablet, capsule, powder, pill, oral liquid or other conventional formulation by pharmaceutical carrier commonly used in above-mentioned each medicinal raw material and the pharmacy and additive or adjuvant.

Viral hepatitis belongs to the traditional Chinese medical science " hypochondriac pain " category, because depressed emotion, or the rage impairing the liver, liver is lost bar and reaches, and catharsis is unfavorable, vapour lock network numbness, and cause hypochondriac pain.If invade in the exopathogen or diet uncomfortable so that damp and hot heresy is pented up in liver and gall, liver and gall are lost in the catharsis bar are reached, also can cause hypochondriac pain.For depression of liver-QI, the hypochondriac pain pain due to the retention of damp-heat in the interior is controlled suitable soothing liver-QI for relieving depression, clearing away heat-damp and promoting diuresis.Monarch drug Radix Bupleuri is the key medicine of soothing liver-QI for relieving depression in the side, energy Shu Da irritability, harmonizing the functional activities of vital QI; Ministerial drug Herba Artemisiae Scopariae bitter cold has the merit of heat clearing away, dampness removing, jaundice eliminating, the kind jaundice that causes; Assistant can heat-clearing and toxic substances removing with Radix Isatidis, bile powder, clear sharp stagnated heat of liver channel, and trimethyl gallic acid is held back and is promoted the production of body fluid, and the protection liver-yin is in case the fraud of yang hyperactivity impairment of YIN; Make with ganoderan flavor cold and little sweetly, have clearing heat and anti-inflammatory functions.This product is again a kind of immunomodulator, can be used for the disease of some immunologic hypofunction, can improve the symptom of Patients with Viral Hepatitis, transaminase lowering, and all medicines match, and are total to soothing liver-QI for relieving depression, the effect of clearing away heat-damp and promoting diuresis.Be applicable to distending pain over the hypochondrium, heating installation discomfort, gastral cavity painful abdominal mass abdominal distention due to dampness-heat in the liver and gallbladder, the depression of liver-QI, diseases such as inappetence.Clinical chronic viral hepatitis, chronic persistent hepatitis and the liver cirrhosis of being usually used in.

This medicine method for making: with the tablet is example, and Fructus Schisandrae Chinensis powder is broken into coarse powder, adds 75% alcohol reflux three times, extracts 3 hours for the first time, extracts 2 hours for the second time, extracts for the third time 1 hour, filter, and merging filtrate, decompression recycling ethanol, standby; Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, second, third time each 2 hours filtered, merging filtrate, being concentrated into relative density is the clear paste of 1.10～1.14 (60 ℃), merges with above-mentioned alcohol extract, being concentrated into relative density is the thick paste of 1.30 (80 ℃), add starch, mixing, drying under reduced pressure, be ground into fine powder, add Pulvis Fellis Suis, krestin again, mixing, make granule, drying adds magnesium stearate, tabletting, the bag film-coat, promptly.

Function with cure mainly: soothing liver-QI for relieving depression, clearing away heat-damp and promoting diuresis.Be used for chronic viral hepatitis, chronic persistent hepatitis and liver cirrhosis.

Usage and dosage: oral, one time 4,3 times on the one.(trade name: GANJIAXIN PIAN)

Advantage of the present invention is: show through pharmacodynamic experiment that 1, medicine of the present invention has the bile secretion of obvious promotion normal rat, the effect of the humoral immunization of enhancing is arranged.Show through the animal acute toxicity test that 2, medicine of the present invention is taken to mice can record the 48g/kg that maximum tolerated dose is suitable crude drug amount, quite 226.8 times of people's consumption, there is not any toxic reaction, also have bigger safety for clinical usefulness.3, show through clinical trial, take medicine of the present invention, with the differential diagnosis in tcm is standard, by therapeutic scheme to depression of liver-QI occurring, (162 examples are organized in the GANJIAXIN PIAN treatment to 197 routine patients of deficiency-weakness of spleen-QI, contrast 35 examples) carried out the clinical treatment research evaluation, observe in conjunction with the variation of its liver function and hepatitis B virus labelling index (HBVM) simultaneously, provide clinical data to its treatment that is used for Type B viral hepatitis, syndrome of stagnation of liver qi and spleen deficiency patients such as this result of the test explanation medicine therapeutic virus hepatitis of the present invention have the syndrome of improving strongly fragrant syndrome of spleen-deficiency, effects such as reduction ALT and hepatocyte are impaired, total effective rate reaches 83.9% (matched group reaches 74.3%), and general curative effect is better than liver-protecting tablet on the market.3, prescription is simple, and compatibility is reasonable, with low cost, drug effect is reliable, evident in efficacy.

The specific embodiment

Further set forth beneficial effect of the present invention below in conjunction with embodiment, test example.

[embodiment 1] GANJIAXIN PIAN

Radix Bupleuri 300 gram, Herba Artemisiae Scopariae 300 grams, Radix Isatidis 300 grams, Fructus Schisandrae Chinensis 317.5 grams, Pulvis Fellis Suis 20 grams, krestin 20 grams, magnesium stearate, starch are an amount of, make 1000 by preceding method.

[test example 1] medicine Pharmacodynamic test of active extract of the present invention

1, experiment material

1.1 medicine

Be subjected to the reagent thing: GANJIAXIN PIAN, route of administration and clinical consistent (oral)

The unit of providing: the big pharmaceutical Co. Ltd in Tonghua side

The preparation labelled amount:

Content: 2.125g crude drug/sheet

Compound method:

Face the time spent, the GANJIAXIN PIAN agent is made the medicinal liquid of desired concn with distilled water; Blank is mixed with corresponding concentration with excipient (white dextrin and magnesium stearate) with distilled water.

Solvent: distilled water

1.2 animal

Animal: healthy Wistar rat, male; Healthy Male Kunming strain mice,

Body weight: body weight 200-250g, body weight 19-22g,

Source, kind, strain, the quality certification: Animal Experimental Study center, Beijing provides.

The quality certification number: SCXK11-00-0008

2, experimental technique and result

2.1 function of gallbladder promoting experiment

Rat common bile duct intubate is selected the healthy male Wistar rat about body weight 250g.

Fasting is 16 hours before the experiment, 20% urethane ip anesthesia, cutting the abdominal cavity open does the derivation of common bile duct intubate and collected bile 30 minutes with the polyethylene tubule, 12 duodenum 12 add glad back 30 minutes, 60 minutes, 90 minutes, 120 minutes each point record bile collecting amounts (ml) to liver, and the bile that calculates each time point increases percentage rate.

Table 1 liver adds and glad rat bile is increased percentile influence

Group dosage number of animals bile growth % (Mean ± SD)

(g/kg) (only) 30 minutes 60 minutes 90 minutes 120 minutes

Matched group-10-10.7 ± 4.9-11.4 ± 8.1-1.5 ± 12.6-3.1 ± 16.2

Positive 100mg/kg 5 49.9 ± 8.4 ^{* *}30.7 ± 15.9 ^{* *}42.1 ± 12.1 ^{* *}15.9 ± 18.7

Liver adds glad 25 24.1 ± 17.2 ^{* *}15.4 ± 28.4 24.0 ± 33.8 13.5 ± 28.6

4 5 38.8±25.5 ^*** 14.8±16.2 ^** 23.6±18.5 ^* 25.7±21.9 ^*

8 5 57.6±20.3 ^*** 46±29.1 ^*** 59.1±29.4 ^*** 44.0±23.3 ^**

Compare with model group ^*P＜0.05, ^*P＜0.01, ^{* *}P＜0.001

The result shows that liver adds the glad obvious promotion bile secretion that has, and its effect has according to dose relationship (dose-denpendent).

2.2 protect the liver experimental technique

Select healthy male mice, body weight 19-22g, Kunming kind.Totally 60, be divided into 6 groups, 10 every group.Model control group, positive drug group, the heavy dose of group of administration, middle dosage group.Small dose group and normal control group.More than each the group, be administered once every day, successive administration 3 days.After the last administration one hour, except that the normal control group, all the other respectively organize lumbar injection 0.1% carbon tetrachloride olive oil solution 0.2ml/20g body weight, get blood after 16 hours, with ALT (ALT/GPT) test kit that Beijing northization fine chemicals Co., Ltd produces, measure ALT.The results are shown in Table 2.

Table 2 liver adds glad influence to mice GPT

Group dosage number of animals GPT (u/ml) t p

X±Se

Normal 10 26.1 ± 5.3

Model 10 262.3+37.6

Positive 10mg/kg 10 96.7+26.4 3.6＜.01

Liver adds glad 8g/kg 10 64.8+23.0 2.2＜.05

4g/kg 10 193.6+29.4 1.4 ＞.05

2g/kg 10 218.6+37.4 .8 ＞.05

The result shows that the heavy dose of administration of GANJIAXIN PIAN has with the model group ratio obvious retardance GPT rising is arranged.

3, to effect of immunologic function

Animal: select BALB/C mice, male, body weight 18-22g, Cavia porcellus, male, body weight 400-450g.

Reagent: during the positive control drug interferon was produced by city's pharmacy three factories, ConA, RPMI1640 were U.S. Sigma

Company's product, calf serum are U.S. Hyclone company product ³H-TdR is by the atomic energy academy of the Chinese Academy of Sciences

Provide; The Costar96 well culture plate.

Instrument: the HUMANYZER-2000 semi-automatic biochemical analyzer, Germany produces; J-6B centrifuge, LS-9800 liquid scintillation counter, U.S. BECKMAN company product; Titertek Cell Harvester550 bull cell harvestor.YAMATO IP-31 CO ₂Incubator.

3.1 mouse immune organ weight test

BALB/C mice, male 60, be divided into 5 groups at random by body weight, be respectively the normal control group, positive drug Radix Tripterygii Wilfordii 0.06g/kg group, liver adds glad 2g, 4g, 8g/kg group.More than each group irritate stomach respectively and give tap water and corresponding medicinal liquid 0.4ml/20g body weight, every day 1 time, continuous 10 days.Behind last administration 24h, to weigh, the sacrificed by exsanguination mice is got thymus, spleen is weighed, and calculates thymus index, index and spleen index (the heavy mg/g body weight of organ).The results are shown in Table 1.

The thymus of GANJIAXIN PIAN 10g, 20g/kg two dosage, spleen/body weight ratio illustrate that apparently higher than matched group this medicine can obviously alleviate the weight of thymus and spleen (difference P＜0.05, P＜0.01, P＜0.001.Positive drug Radix Tripterygii Wilfordii 0.06g/kg also has identical effect (all P＜0.05)

Table 1 GANJIAXIN PIAN is to mouse immune organ weight's influence

Group number of animals dosage thymus index index and spleen index

(only) be the ((Mean ± SD) of Mean ± SD) (g/kg)

Matched group 12-1.78+0.38 4.21+0.54

Interferon 12 0.06 2.59+0.84 ^*5.86+1.21 ^{* *}

Liver adds glad 12 2 2.19+0.52 ^*5.21+0.78 ^*

12 4 1.98+0.49 5.05+0.49 ^*

12 8 1.77+0.44 4.79+0.60

Annotate: compare with matched group: ^*P＜0.05, ^*P＜0.01, ^{* *}P＜0.001, below identical.

3.2 mouse antibodies forms cell antibody and generates test

BALB/C mice, grouping, administration are the same.After administration in the 7th day, every ip5% sheep red blood cell (SRBC) 0.2ml sensitization.After the sensitization the 5th day, the sacrificed by exsanguination mice was won spleen, makes splenocyte suspension with 1640 liquid by 15mg spleen weight/ml.Get some in test tube, every pipe adds splenocyte suspension, 0.2% sheep red blood cell (SRBC), 1: 10 each 0.5ml of complement successively, and other establishes and does not add the complement control pipe, incubation 1h in the rearmounted 37 ℃ of water-baths of mixing, 3000rpm/min, centrifugal 5min, get supernatant with distilled water diluting after in 405nm wavelength colorimetric.

Liver adds and gladly mouse antibodies is formed the influence that cell antibody generates sees Table 2 as a result.

The increase antibody of GANJIAXIN PIAN 10g, 20g/kg two dosage energy highly significant generates (all P＜0.05).

Table 2 liver adds the glad influence that mouse antibodies is formed the cell antibody generation

Group number of animals dosage haemolysis OD value

(only) be (Mean ± SD) (g/kg)

Matched group 12-0.838 ± 0.19

Interferon 12 0.06 1.211 ± 0.37 ^{* *}

Liver adds glad 12 2 1.027 ± 0.39 ^*

12 4 0.838±0.19

12 8 0.879±0.21

The conclusion GANJIAXIN PIAN can obviously increase mouse thymus, spleen weight, obviously improves mouse antibodies and forms the cell antibody generative capacity, proves that liver adds the glad humoral immunization of the enhancing effect that has.

Sum up

The GANJIAXIN PIAN oral administration can block the GPT rising effect that carbon tetrachloride causes mouse liver injury, and the bile secretion of obvious promotion normal rat is arranged, and the effect of the humoral immunization of enhancing is arranged.

The animal acute toxicity test of [test example 2] medicine of the present invention

The mensuration of maximum tolerated dose

1. make a summary

The test sample extract is pressed Cmax (suitable 1.06g crude drug amount/ml), maximum volume (0.4ml/10g body weight) gives mice and once irritates stomach 0.8ml/20g body weight, dosage is 48.0g crude drug amount/kg, for the people intends dosage (226.8 times of 12.7g crude drug amount/60kg) every day.Observation is 7 days continuously, and none example is dead as a result, and all are movable normal for animal, and body weight and food-intake and control animals compare, the non-toxic reaction performance.The maximum tolerance of mice oral administration is suitable crude drug amount 48.0g crude drug amount/kg, maximum 226.8 times of tolerating multiple behaviour consumption.

2. test objective:

Observe mice single on the one and irritate the maximum tolerated dose surveyed that stomach gives test sample.

3 are subjected to the reagent thing:

Title: GANJIAXIN PIAN

The unit of providing: the big pharmaceutical Co. Ltd in Tonghua side

Preparation labelled amount: 1.06g crude drug amount/sheet

Compound method:

Face the time spent, test sample extract tablet is mixed with the medicinal liquid of desired concn with distilled water; Blank is prepared corresponding concentration with excipient (white dextrin and magnesium stearate) with distilled water.

Solvent: distilled water

4. animal:

Source, kind, strain, the quality certification: Animal Experimental Study center, Beijing provides, ICR strain, SPF level mice.The quality certification number: SCXK 11-00-0008.

Body weight: 18.1 ± 0.8g

Sex: male and female half and half

Number of animals: 40

5. test method:

Oral, route of administration is with clinical consistent.Dose is represented with the test sample extractive content.

Cmax: suitable crude drug amount 1.06/ml maximum volume: 0.4ml/10g body weight.

Animal is divided into two groups at random by body weight, 20 every group, male and female half and half.One group is given test sample concentration is 0.35g/ml, presses the 0.4ml/10g body weight, once irritates stomach.Another group is irritated stomach for excipient matched group equal-volume, observes continuously then 7 days, writes down animal every day and has or not abnormal response.Before medicine and after the off-test, each claims the weight of animals once.

6. result of the test:

Maximum concentration and the maximum gastric capacity 0.4ml/10g body weight of irritating of mice according to test sample 0.35g tablet/ml are calculated, dosage is suitable crude drug amount 48g/kg, quite the adult intends 226.8 times of consumption 12.7g/60kg every day. and none example is dead in all animals 7 days, body weight gain and matched group no significant difference (seeing Table), all no abnormal performances such as animal activity, fur color and luster, feces, feed.There is not any toxic reaction.

Table GANJIAXIN PIAN extract is to the influence of mice body weight

Group dosage number of animals gonosome heavy (Mean+SD)

(g/kg) after the preceding administration of (only) other administration

Matched group-10 17.9 ± 0.67 25.1 ± 1.23

- 10 18.6±0.52 30.4±1.84

Administration group 48 10 17.7 ± 0.67 25.2 ± 2.21

48 10 19.6±0.51 30.7±2.86

7. conclusion

The maximum tolerated dose surveyed of the oral test sample of mice is suitable crude drug amount 48g/kg, quite 226.8 times of people's consumption, does not have any toxic reaction.Estimating thus clinically has bigger safety with test sample.

The clinical experiment report of [test example 3] medicine of the present invention

Clinical unit: Beijing Hospital of Traditional Chinese Medicine

Summary

Syndrome of stagnation of liver qi and spleen deficiency is the modal syndrome of the spleen-stomach disease, and its reason is the dirty imbalance of liver spleen two, the liver failing to maintain the normal flow of QI, and then influenced the fortune function of spleen or caused deficiency-weakness of spleen-QI, and no resource of generating and transforming QI and blood causes deficiency of liver-blood and can not nourishing the liver.The liver failing to be nourished, depression and stagnation of QI.The syndrome that usually can occur depression of liver-QI, deficiency-weakness of spleen-QI clinically.This experiment is standard with the differential diagnosis in tcm, by therapeutic scheme the patient who depression of liver-QI, deficiency-weakness of spleen-QI occur has been carried out GANJIAXIN PIAN clinical treatment research evaluation.In conjunction with the variation observation of its liver function and hepatitis B virus labelling index (HBVM), provide clinical data simultaneously to its treatment that is used for Type B viral hepatitis.

The GANJIAXIN PIAN clinical experiment

Be subjected to the reagent thing: GANJIAXIN PIAN, route of administration and clinical consistent (oral)

The unit of providing: the big pharmaceutical Co. Ltd in Tonghua side

Preparation labelled amount: 2.125g crude drug/sheet

Therapeutic scheme

One, case choice criteria

(1) diagnostic criteria

1. Chinese medical discrimination

The liver depression syndrome of spleen-deficiency

(1) the breast side of body or few distention and fullness in the abdomen are scurried pain; (1) spiritlessness and sparing of words, fatigue and asthenia;

(2) heating installation is frequent, or general acid regurgitation water is arranged; (2) the stomach poor appetite is few or appetite is poor;

(3) irritated irritability; (3) dull pain in the epigastrium;

(4) insomnia and dreamful sleep; (4) abdominal distention after meal, or afternoon, abdominal distention increased the weight of;

(5) bitter taste in the mouth and dry throat, or pharyngeal if any the thing sense of obstruction; (5) stool clear and not well or the time do when clear;

(6) tongue limit point is red slightly, the little Huang of tongue fur; (6) pale tongue, tongue body are fat slightly or indentation arranged.

(7) stringy pulse.

Syndrome of stagnation of liver qi and spleen deficiency

(1) syndrome of stagnation of liver qi and spleen deficiency: refer to that based on liver insufficiency of the spleen is time person.All have stagnation of liver-QI and see disease more than 4, and beer void is seen 2 above persons of disease, and is promptly diagnosable.

(2) the inferior card of stagnation of liver-QI with deficiency of the spleen: refer to that based on insufficiency of the spleen the liver youth is time person.All have insufficiency of the spleenly see disease more than 4, stagnation of liver-QI is seen 2 above persons of disease, and is promptly diagnosable.

(3) stagnation of liver-QI with deficiency of the spleen witness: refer to that stagnation of liver-QI does not equate the person substantially with insufficiency of the spleen.All have insufficiency of the spleenly see that stagnation of liver-QI is seen 3 above persons of disease, and is promptly diagnosable more than 3 of the diseases (picture of the tongue for indispensable).

2. primary symptom grade scale

Divide level Four: severe symptoms (4 minutes); Inferior weight (3 minutes), in (2 minutes); Gently (1 minute)

According to the grading (see Chinese medicine for details and declare approval guideline) to the ill of following syndrome

1. spiritlessness and sparing of words, fatigue and asthenia (explaining) with Y1.

2. stomach poor appetite few (Y2)

3. dull pain in the epigastrium, abdominal distention after meal (Y3)

4. clear and not well (Y4) defecates

5. the breast side of body, distention and pain in the lower abdomen (Y5)

6. heating installation, acid regurgitation (Y6)

7. irritated irritability, or insomnia and dreamful sleep (Y7)

8. xerostomia hardship, or pharyngeal if any thing sense of obstruction (Y8)

(2) test case

1. include the case standard in

Clarifying a diagnosis is syndrome of stagnation of liver qi and spleen deficiency, may influence various diseases (as being associated with various serious chronic diseases) patient that curative effect of medication is estimated and get rid of other, all can include test in.

2. case exclusion standard (inadaptation or rejecting standard)

(1) may influence the various diseases (as being associated with various serious chronic diseases) that syndrome of stagnation of liver qi and spleen deficiency or curative effect of medication are estimated.

(2) gestation or women breast-feeding their children are to this medicine allergy sufferers at under-18s or over-65s the age.

(3) be associated with serious primary disease such as cardiovascular system, liver, kidney, hemopoietic system, psychotic.

(4) do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safe judgement person.

Two, observation index

1. safety observation

(1) general health check-up project.

(2) blood, routine test, liver, kidney function test.

2. health giving quality observation

(1) detailed medical history-taking, and press the detailed observational record of variation that primary symptom is shown in the empty grading of stagnation of liver-QI board.

(2) can carry out according to physical and chemical indexs such as the observation of assertive evidence concrete condition HBVM, ALT, AST, TP, ALB, A/G and bilirubin.

Three, curative effect determinate standard

1. clinical cure: the syndrome of stagnation of liver-QI with deficiency of the spleen (Y) disappears, and other relevant inspections reach normal basically.

2. produce effects: the stagnation of liver-QI with deficiency of the spleen syndrome alleviates each disease and reduces (∑ (y more than 2 minutes _{After the i treatment}-y _{Before the i treatment}) 〉=16, i=1 ..., 8), other are relevant checks and be clearly better (in the experimental monitoring measuring index such as liver function, has at least a decline scope to surpass the width of its normal value.For example, the ALT regime values is 8-40IU/L, and it is for being clearly better that then decline scope surpasses 32IU/L).

3. effective: the stagnation of liver-QI with deficiency of the spleen syndrome alleviates each disease and reduces (∑ (y more than 1 minute _{After the i treatment}-y _{Before the i treatment}) 〉=8), other are relevant checks that the persons of taking a favorable turn (in the experimental monitoring measuring index such as liver function, have at least a decline scope to surpass half of width of its range of normal value, promptly surpass and measure the individual variation equal error and disturb.For example, the ALT regime values is 8-40IU/L, and it is for being clearly better that then decline scope surpasses 16IU/L).

4. invalid: the stagnation of liver-QI with deficiency of the spleen syndrome alleviates the reduction (∑ (y that do not reach 1 fen _{After the i treatment}-y _{Before the i treatment})＜8),

The no improvement person of other relevant inspections.

The relevant requirements of four, observing, writing down, summing up

By designing requirement, unified form is made itemized record, observes untoward reaction or unexpected toxicity, and tracing study.Various data are done statistical disposition.

Clinical trial

The contrast medication: liver-protecting tablet, usage: one time 4,3 times on the one.

The GANJIAXIN PIAN dosage regimen: advise usage and consumption according to animal maximum tolerated dose, toxicity zoopery and medicine provider, oral administration one month, one time 4,3 times on the one.

Two groups of treatment phases are all taken Vc by same usage and consumption, and Vb and glucurolactone sheet are to guarantee the auxiliary medication treatment that protects the liver.

Grouping: principle is the pairing factor with the syndrome weight of stagnation of liver-QI with deficiency of the spleen, 5: 1 (GANJIAXIN PIAN groups: the liver-protecting tablet group) by distinguishing set of dispense GANJIAXIN PIAN treatment group (162 example) at random, liver-protecting tablet group (35 example) patient.

Treatment is summed up

One, case data (seeing Table 1-6) (herein omit) before the treatment: table 1 to the analysis result of table 4 data reflected two groups of cases age, the course of disease, be in hospital and clinic case disease situation basically identical when.Table 5 and table 6 data have further proved the degree and the hepatopathy typing situation basically identical of the hepatocyte injury of two groups of cases.In 162 cases of this clinical experiment, have simultaneously to be not less than 92.6% patient at least and to be viral hepatitis (11.4% and 80% is respectively hepatitis A and hepatitis B), wherein, have 75.9% to be hepatitis B.And in 35 examples of matched group, 91.4% is viral hepatitis (have 80% for hepatitis B).Therefore, this effectiveness study object is mainly the patient of viral hepatitis from Western medicine diagnose.

Two, treatment back case data and efficacy analysis (seeing Table 7-13) (omit herein, table 10,12,13 is provided)

Brief summary

With the different disease of card, different disease is the characteristics of tcm diagnosis with card.It is the important rule of tcm clinical practice that dialectical opinion is controlled.Being as the criterion with differential diagnosis in tcm, the Chinese medicine clinical efficacy being made the objective evaluation that meets theory of Chinese medical science be not only Chinese medicine clinical drug safety, effective prerequisite, also is the controlled key of Chinese medicine quality.This experiment is standard with the differential diagnosis in tcm, by therapeutic scheme the 197 routine patients (162 examples are organized in the GANJIAXIN PIAN treatment, contrast 35 examples) that depression of liver-QI, deficiency-weakness of spleen-QI occur has been carried out the clinical treatment research evaluation.In conjunction with the variation observation of its liver function and hepatitis B virus labelling index (HBVM), provide clinical data simultaneously to its treatment that is used for Type B viral hepatitis.Syndrome of stagnation of liver qi and spleen deficiency patients such as this result of study explanation GANJIAXIN PIAN treatment viral hepatitis have the syndrome of improving strongly fragrant syndrome of spleen-deficiency, reduce effects such as ALT and hepatocyte be impaired.The GANJIAXIN PIAN total effective rate reaches 83.9%, and contrast reaches 74.3%.Can be the clinical treatment hepatopathy ancillary drug is provided.

Table 10 liang group case curative effect relatively

Group

Other total of hepatitis A hepatitis B

The routine number of example number healing produce effects enabledisable routine number healing produce effects enabledisable is cured total the healing of the routine number healing of produce effects enabledisable produce effects enabledisable and is shown effective %

Liver adds glad 27 13 932 123 35 31 35 22 12 1542 162 49 45 42 26 83.9

48.1 33.3?11.1?7.4 28.5 25.2?28.5?17.9 8.3 41.7 33.3 16.7 30.2?27.8 25.9 16.0

Liver-protecting tablet 42101 28 498730111 35 6 11 99 74.3

50.0 25.0?0.0 25.0 14.3 32.1?28.6?25.0 0.0 33.3 33.3 33.3 17.1?31.4 25.7 25.7

Ridit analyzes: Ridit analysis result between the hepatitis A group: R value p＜0.05 is credible to be limited to 0.19～0.77, comprises 0.5, does not see significant difference (p＞0.05) between the explanation group.

Ridit analysis result between the hepatitis B group: R value p＜0.05 is credible to be limited to 0.19～0.77, comprises 0.5, does not see significant difference (p＞0.05) between the explanation group.

Ridit analysis result between other type group: R value p＜0.05 is credible to be limited to 0.51～0.78, does not comprise 0.5, and there were significant differences between the explanation group (p＜0.05).

Two groups of cases amount to curative effect relatively, and the Ridit analysis result: R value p＜0.05 is credible to be limited to 0.32～0.51, and the edge comprises 0.5, illustrates that GANJIAXIN PIAN group general curative effect obviously is better than liver-protecting tablet,

But difference does not reach p＜0.05 significant level.

Two groups of influences that renal function change list 13 is treated electrocardio, routine blood test, routine urinalysis, liver function before and after table 12 treatment

Before controlling, project group case controls the front and back, back than p project group case Before the treatment Treat after 1 monthP

Normal unusual normal unusual

The BUN liver adds glad group 162 5.86 ± 1.72 4.49 ± 1.21＞0.05 routine urinalysis livers and adds glad 162 143 19 146 22＞0.05

Liver-protecting tablet group 35 5.98 ± 1.66 4.91 ± 1.13＞0.05 liver-protecting tablet 35 31 4 34 1

The Cr liver adds glad group 162 87.43 ± 16.0 89.18 ± 18.90＞0.05 electrocardio livers and adds glad 162 139 23 142 20＞0.05

Liver-protecting tablet 35 89.5 ± 14.9 85.17 ± 16.14＞0.05 liver-protecting tablet 35 29 6 29 6

Renal function there is not obvious influence, (P＞0.05) before and after two groups of treatments.Blood, urine, all no abnormal change of electrocardio (P＞0.05) before and after the treatment.

Take treatment in a word after one month, have no adverse reaction.Do not find obvious toxic-side effects, illustrate that the test sample clinical practice is safe and reliable.

Claims (1)

1, a kind of medicine for the treatment of hepatitis is characterized in that it makes medicament by the raw material of following weight: Radix Bupleuri 240-360 gram, Herba Artemisiae Scopariae 240-360 gram, Radix Isatidis 240-360 gram, Fructus Schisandrae Chinensis 250-380 gram, Pulvis Fellis Suis 15-25 gram, krestin 15-25 gram.