CN101385778A - Ganjiaxin tablet - Google Patents

Abstract

The invention relates to a Chinese materia medica preparation, i.e. a ganjiaxin tablet for treating hepatic diseases. 1000 ganjiaxin tablets are made from 317.5g of Chinese magnolivine fruit, 300g of bupleurum root, 300g of oriental wormwood, 300g of isatis root, 20g of polystictus glycopeptide, 20g of pig gall powder, 100g of starch and 3.5g of magnesium stearate. The tablet is used for treating diseases such as chronic viral hepatitis, persistent hepatitis, hepatocirrhosis and the like, and has the advantage of reliable and significant curative effect.

Description

GANJIAXIN PIAN

Technical field

The present invention relates to a kind of Chinese medicine preparation, promptly treat the medicine GANJIAXIN PIAN of hepatopathy.

Background technology

In prior art, the medicament categories of treatment hepatopathy is various, and effect differs, and its prescription is each has something to recommend him, but that shortcoming is a therapeutic effect is low.

Summary of the invention

The objective of the invention is provides a kind of GANJIAXIN PIAN for the treatment of the hepatopathy better efficacy at above-mentioned deficiency.

Technical solution of the present invention is: a kind of GANJIAXIN PIAN is characterized in that being made by the raw material of following weight: Fructus Schisandrae Chinensis 317.5g, Radix Bupleuri 300g, Herba Artemisiae Scopariae 300g, Radix Isatidis 300g, Polystictus Glycopeptide 20g, Pulvis Fellis Suis 20g, starch 100g, magnesium stearate 3.5g makes 1000.

Fructus Schisandrae Chinensis in the side: the record Fructus Schisandrae Chinensis has multiple functions such as " QI invigorating, tonifying for the deficiency are supported the five internal organs, make eye bright strengthening bone and muscle " in the Compendium of Material Medica, and its nature and flavor acid, sweet, warm has astringent or styptic treatment for spontaneous sweating the promoting the production of body fluid of convergence, the effect of protection liver-yin.Modern pharmacological research confirms: multiple pharmacological effect such as Fructus Schisandrae Chinensis and preparation thereof have protecting the liver, reduce glutamate pyruvate transaminase, function of gallbladder promoting, the clinical treatment that is used for various hepatopathys.

Radix Bupleuri: its nature and flavor hardship, be slightly cold, return liver, gallbladder meridian.Have reconciling superficies and interior, soothing the liver, the effect of yang invigorating.Be used for the treatment of hepatopathy distending pain in the chest and hypochondrium.

Herba Artemisiae Scopariae: its nature and flavor hardship, suffering are slightly cold.Return spleen, stomach, liver, gallbladder meridian.Has clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer.Be used for the treatment of jaundice oliguria, infectious jaundice type hepatitis.

Radix Isatidis: its nature and flavor hardship, cold.Effect with heat-clearing and toxic substances removing,

Pulvis Fellis Suis: its nature and flavor hardship, cold.Return liver, gallbladder, lung, large intestine channel.Has heat-clearing and toxic substances removing, the effect of clear sharp stagnated heat of liver channel.

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, can 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 is with Radix Isatidis, and bile powder can heat-clearing and toxic substances removing, clear sharp stagnated heat of liver channel.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, belch 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.

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.

Six-element medical material in the prescription, Fructus Schisandrae Chinensis powder is broken into coarse powder, adds 75% alcohol reflux three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, filter, merging filtrate, decompression recycling ethanol, standby; Herba Artemisiae Scopariae, Radix Bupleuri and Radix Isatidis decoct with water three times, and 3 hours for the first time, second and 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 krestin, Pulvis Fellis Suis again, mixing, make granule, drying adds magnesium stearate, tabletting, the bag film-coat, promptly.

Advantage of the present invention is: GANJIAXIN PIAN is that the clinician is in clinical practice for many years, select soothing liver-QI for relieving depression for use according to Traditional Chinese medical theory, the treatment rule of clearing away heat-damp and promoting diuresis, compatibility Fructus Schisandrae Chinensis, Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, bile powder, be used for chronic viral hepatitis, chronic persistent hepatitis, the treatment of diseases such as liver cirrhosis.Through long-term clinical verification, this medicine reasonable recipe, compatibility is proper, determined curative effect.Organize 162 examples through the GANJIAXIN PIAN treatment, contrast 35 examples and carried out the clinical treatment research evaluation, the GANJIAXIN PIAN total effective rate reaches 83.9% (contrast reaches 74.3%), can be the clinical treatment hepatopathy ancillary drug is provided.

Below in conjunction with embodiment the present invention is described in further detail.

The specific embodiment

Embodiment 1: GANJIAXIN PIAN

GANJIAXIN PIAN is by Fructus Schisandrae Chinensis 317.5g, Radix Bupleuri 300g, and Herba Artemisiae Scopariae 300g, Radix Isatidis 300g, Polystictus Glycopeptide 20g, Pulvis Fellis Suis 20g, starch 100g, magnesium stearate 3.5g makes 1000.

Experimental example 1: clinical report

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), its treatment that is used for Type B viral hepatitis is provided simultaneously

Clinical data.

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, insufficiency of the spleenly sees 2 above persons of disease, 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), light (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 (Y1 statement)

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 (∑ (yi treatment back-yi treatment is preceding) 〉=16 more than 2 minutes, i=1,, 8), other are relevant checks and be clearly better (has at least a decline scope to surpass the width of its normal value in the experimental monitoring measuring index such as liver function.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 (∑ (before the yi treatment back-yi treatment) 〉=8) more than 1 minute, other are relevant checks that the persons of taking a favorable turn are (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 then decline scope surpasses 16IU/L for being clearly better).

4. invalid: the stagnation of liver-QI with deficiency of the spleen syndrome alleviates, and reduces not reach (∑ (before the yi treatment back-yi treatment)＜8) more than 1 minute, and other are about checking no improvement person.

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 group: 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 before the treatment.In 162 cases of this clinical experiment, have and be not less than 92.6% patient at least and be viral hepatitis (11.4% and 80% is respectively hepatitis A and hepatitis B), wherein, have 75.9% to be hepatitis B. 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.

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.

Claims (1)

1. [claim 1] a kind of GANJIAXIN PIAN is characterized in that being made by the raw material of following weight: Fructus Schisandrae Chinensis 317.5g, and Radix Bupleuri 300g, Herba Artemisiae Scopariae 300g, Radix Isatidis 300g, Polystictus Glycopeptide 20g, Pulvis Fellis Suis 20g, starch 100g, magnesium stearate 3.5g makes 1000.