CN1085794A - Capsule for curing hepatitis - Google Patents

Abstract

The present invention relates to be used for the treatment of the Chinese patent medicine compositions capsule for curing hepatitis of chronic hepatitis, it is characterized in that: property of medicine compositions is by stem and leaf of Radix Ginseng total saponins, and silymarin, oleanolic acid, Rhizoma Polygoni Cuspidati anthraquinone are formed.Make capsule after adding filler, through animal and clinically research and test, the present invention is to chronic hepatitis, particularly hepatitis B and by its platelet that causes, leukopenia disease tangible curative effect is arranged, synergism between the drug component, to combine with the treatment of partial symptom and Signs to the control of whole pathological changes and impel the pathological changes benign development, progressively rehabilitation is to curing.

Description

Capsule for curing hepatitis

The invention belongs to medicine field, relate to that a kind of it is raw material that oleanolic acid, Rhizoma Polygoni Cuspidati are feared quinone, is used for the treatment of hepatitis with plant the effective elements of the medicine stem and leaf of Radix Ginseng total saponins, silymarin, in order to the Chinese patent medicine compositions of treatment chronic hepatitis.

At present, it almost is a blank that chronic hepatitis is had the medicine of sure healing curative effect, reason is that the pathogenesis of hepatitis is complicated, and the someone points out that chronic hepatitis comes down to the comprehensive symptom grouping based on the multisystem pathological changes of immune system, and this viewpoint is fully confirmed by clinical medicine practise.And existing drug design, the antiviral chemotherapeutics, immunomodulator, anti-liver injury medicament, do not match with the whole pathological changes of hepatitis, can only play the effect that improves sings and symptoms, and do not reach the purpose of cure diseases, in order to improve the therapeutic effect of medicine for curing hepatitis, engage more than 150 medical expert's screening to choose the medicine of four good treatment hepatitis by Ministry of Public Health, they are LIANBENSHUANGZHI DIWAN of institute of Materia Medica,Chinese Academy of Medical Sciences, the Hepat Amine of Guangzhou Qiaoguang Pharmaceutical Plant, the 6-Amino Acid Injection of Shenyang No. 1 Pharmaceutical Factory, liver peace dry syrup [the medical industry information 1987 of Tianjin pharmacy three factories of central authorities; (6); 22].Described four kinds of medicines neither be treated the specific drug of hepatitis, Shou Xuan LIANBENSHUANGZHI DIWAN wherein, and it is remarkable by short term effect just to fall the enzyme the turbid descending, and late result is still dissatisfied, and to the poor effect of the turning out cloudy (new drug and clinical 1986 of hepatitis b surface antigen positive; 5(1); 39).In research to the chronic hepatitis treatment medicine; people are placed on attention in the research to Chinese medicine; find that Chinese medicine has much curative effect to the treatment chronic hepatitis; for example; with silymarin is that the liver benefiting of raw material is rather for liver subcutaneous ulcer adjuvant; has biomembranous effect in stabilized cell and the cell; promote the bile secretion effect; chronic hepatitis all there is certain effect; oleanolic acid has protective effect to hepatic injury; also have the effect that promotes liver cell regeneration, thereby in order to treat urgency; chronic hepatitis is as the oleanolic acid capsule of present employing; though described two kinds of Chinese patent medicines have certain curative effect to hepatitis; but do not have improvement and the adjusting of consideration to each systemic-function of human body in the design of medicine, though the patient takes multiple medicine simultaneously, dosing can not be cured greatly.

The object of the present invention is to provide a kind of is raw material with the plant the effective elements of the medicine, when improving and regulating each systemic-function of human body, improves the Chinese patent medicine combination capsule for treating hepatitis that can cure chronic hepatitis of the various sings and symptomses of hepatitis.

Above-mentioned purpose of the present invention realizes by this technical scheme, be that it is that medicinal ingredient adopts stem and leaf of Radix Ginseng total saponins, silymarin, oleanolic acid, Rhizoma Polygoni Cuspidati are feared quinone, add the capsule of making behind the filler, stem and leaf of Radix Ginseng total saponins accounts for 40～44% in the patent medicine, silymarin accounts for 29～32%, and Rhizoma Polygoni Cuspidati is feared quinone 16～18%, and oleanolic acid accounts for 9～11%.

Stem and leaf of Radix Ginseng total saponins is the saponin mixture that extracts in the Stem and leaf of Radix Ginseng in the above-mentioned medicinal ingredient, the human organism there is special regulating action, energy across-the-board regulation and recovery body function, the ill mark sense normal condition that the different causes of disease are caused changes, and the function of the double tonification of treatment is arranged.

Silymarin is Compositae Silybum plant platymiscium Herba Silybi mariani Silybum mahauum(1) the refining gained of the abstract of Gaertn fruit, be a kind of flavone compound, wherein contain silibinin, silidianin, Silychristin and silybonol.

The chemical name of oleanolic acid is 3 beta-hydroxies-12-alkene-28-oleanolic acid, and molecular formula is C ₃₀H ₄₈O ₃

What Rhizoma Polygoni Cuspidati was feared dry rhizome that quinone is polygonaceae plant Rhizoma Polygoni Cuspidati Polygonum Cuspidatum Sieb.el Zucc and root fears the quinone extract, has the leukocyte of liter and hematoblastic effect.

The usage and the consumption of patent medicine of the present invention are: oral, one time 1～2,3 times on the one, can reach more than 1 year the course of treatment.

The preparation method of patent medicine of the present invention is each medicinal ingredient to be mixed in proportion the back add filler, adopt existing capsule preparation method thereof to dress up every capsule that contains 0.23g property of medicine thing and filler thereof, the best proportion relation of each medicinal ingredient is in the patent medicine: stem and leaf of Radix Ginseng total saponins 43.5%, silymarin accounts for 30.5%, Rhizoma Polygoni Cuspidati is feared quinone 17.3%, oleanolic acid 8.7%.Filler can adopt glucose, starch, Tremella powder or astragalus membranaceus powder, is the best to adopt Tremella powder, and it had both had a figuration effect, had certain tonic effect again.

Sub-acute toxicity test method and result that patent medicine of the present invention is done on one's body animal are as follows:

With every milliliter of suspension that contains patent medicine 500mg of normal saline preparation, get ten (male) body weight of healthy white rat, 200 ± 10g, be divided into two groups at random, every group 5, test group gastric infusion every day 5ml(pastille 500mg), be equivalent to be grown up and use 100 times of daily dose always, use normal saline 5ml simultaneously, irritate stomach to matched group, once a day, continuous use one month is weighed then and is put to death, and gets blood and makes biochemical analysis, and the taking-up heart, liver, lung, kidney, brain, spleen, the adrenal gland, thymus, stomach, intestine and small intestine, testis, epididymises etc. organize organ pipe malingering reason to check, body weight as a result, hemogram, organ pipe is organized equal thing abnormal change, it is reported, rat to the dosis tolerata of medicine according to the weight than in becoming high more than 60 times then for being safety (Chinese herbal medicine communication 1979.(9) .35).

2. biochemistry and body weight change result are as follows:

Conclusion: to rat clothes January, animal is all no abnormal with adult 100 times of dosage for capsule for curing hepatitis.

Pathologic finding shows, two treated animal body weight and outward appearance zero difference, and all thing is unusual for the heart of administration group, lung, kidney, brain, spleen etc., and the liver matched group is big than the administration group, and be lark, the administration group is a bronzing.Mirror is observed down and is found, the lobules of liver structure existence of matched group, and the liver plate is arranged crowded, and sinus hepaticus narrows to disappearance, hepatocyte cloudy swelling and spotty necrosis, and administration group lobules of liver structure is normal, and the liver plate is arranged does not have disorder, and sinus hepaticus does not have expansion and narrows down, and hepatocyte shape is whole normal.Prove that thus the present invention has the effect that improves rat hepatocyte substance metabolism.

Patent medicine of the present invention observation on probation clinically:

Select chronic delay hepatitis (CPH) 40 examples, chronic active hepatitis (CAH) 10 examples.Random pair is divided into treatment group and matched group, every group of each 25 example (CPH 20 examples+CAH 5 examples), its diagnosis all meets " viral hepatitis is prevented and treated scheme " middle CPH that infectious disease academic meeting in the whole nation, Nanning in 1984 is drafted, the standard of CAH defined.

Treatment group: male 10 examples, women 15 examples, 20 years old～50 years old 23 example,＞50 years old, 2 examples, the course of disease 1.1～7.6 years, average 3.2 years.

Matched group: male 10 examples, women 15 examples, 20～50 years old 23 example,＞50 years old, 2 examples, the course of disease 1.6～5.4 years, average 3.2 years.

Two. observation item:

1. symptom (pain in the hepatic region, abdominal distention, stomach poor appetite, weak, be hard and dry) and sign (liver is big, spleen is big, ascites, spider angioma, liver palm).

2. hepatitis B virus (HBV) detects sign: HBsAg, anti-HBs, HBeAg, anti-HBe, HBcAg, anti-HBC, and anti-HBc～1gM, DNA～P, PHSA all uses solid-phase radioimmunoassay (China, dimension mill 3V diagnostic techniques company provides the examination box).

3. liver function: TT ZNT GPT, serum albumin, globulin.

Three. Therapeutic Method:

The short capsule for curing of hepatitis B is organized as treatment, and silybin 75mg+ bifendate 10mg+VitC 100mg organizes in contrast.Make two groups of medicament appearances, shape, capsule that color is identical, hold in close confidence before making known.Respectively every group everyone one time one oral, days three times, three months is a course of treatment, serve on 1 year.All do the detection of every observation index before, during and after the treatment, refuse to obey any other Chinese medicine and western medicine and alleviating alcohol addiction simultaneously and Fructus Capsici in the therapeutic process.

Four. the efficacy assessment standard:

Undertaken by " Antihepatitis medicament clinical research guideline " curative effect judgment criteria and reference " viral hepatitis is prevented and treated scheme (trying) " that Ministry of Public Health is issued.

1. basic the healing: it is normal that treatment back symptom, sign and every virus detect index, liver function, the full recovery of serum Archon albumen, continues 1 year constant person.

2. select 2 in four more than produce effects: DNAP, HBeAg, HBcAg, the anti-HBc～1gM()+a HBsAg12 monthly lasting cloudy commentaries on classics person.

3. effective: outside the cloudy commentaries on classics of HBsAg, all the other symptoms, sign, viral index, liver function, Archon albumen all has the above normal person of recovery of binomial index.

4. invalid: no change person before and after the treatment.

The result:

One. the situation of change of symptom and sign (seeing Table 1), as seen from Table 1, the treatment group is compared for two groups significantly better than matched group, and symptom and sign all have highly significant difference (P＜0.01).

Table 1, the situation of change of symptom and sign before and after the treatment:

Three. liver function and variation (seeing Table 3) white, globulin

Table 3, the situation of change of liver function before and after the treatment, white, globulin:

Unusual 5 examples of treatment group: TT, normal 2 examples are recovered in the treatment back, improve 3 examples; Unusual 4 examples of ZnT, normal 1 example of the treatment extensive degree in back.Improve 2 examples, an example does not have improvement; Unusual 1 example of GPT, normal 1 example is recovered in the treatment back.Unusual 2 examples of matched group: TT, unusual 4 examples in treatment back, abnormal ascending 2 examples; Normal before the ZnT treatment, unusual, abnormal ascending 1 example of treatment back 1 example; No change before and after the GPT treatment, two groups of contrast differences remarkable (P＜0.05).Average 4.63g rises to 5.1g% before the treatment of albumin treatment group after the treatment; 2.33g%(surpasses arm's length standard 3.2g% before the globulin treatment 5 examples), it is normal to drop to 2.42%(four routine recoveries after the treatment, 1 example does not have improvement).Matched group: 4.77g% before the albumin treatment, rise to 5.02% after the treatment, the 3.55g%(3 example surpasses normal value 3.2g% before the globulin treatment) drop to 2.27g% after the treatment, two groups of contrasts are white, globulin does not have significant difference (P＜0.05).

Four. two groups of curative effects compare (seeing Table 4)

（P＜0.01）

Treatment group total effective rate 76%, the matched group total effective rate has highly significant difference (P＜0.01) for 20%, two group.

Discuss:

One. therapeutic evaluation:

Capsule for curing hepatitis is the pure Chinese medicinal preparation of the treatment chronic hepatitis extracted from Chinese medicine, from 25 routine clinical research results, no matter be the disappearance of symptom and sign, hepatitis B virus detects the control of index, liver function recovery is normal, and Archon is proteic multiple often all is better than matched group significantly: total effective rate 76% also is higher than matched group 20% significantly, it seems at present the treatment chronic hepatitis B it still be recommendable medicine.

Two. toxic and side effects:

Through clinical observation for many years; all there is not obvious toxic and side effects; have only individual patients left lower quadrant dull pain in therapeutic process, to occur; just meaning sense is arranged, loose stool, urine is dark brown; this is owing to exist Rhizoma Polygoni Cuspidati to fear the cause of quinone; drug withdrawal just ends, and takes also for a long time not affect the situation as a whole, and the heart, liver, kidney and bone marrow are also had protective effect.

Three. drug effect characteristics and mechanism:

This medical instrument has resisting fatigue, appetite stimulator, and town's essence is calmed the nerves, antiviral, antitumor prevents chromosomal aberration, the anti-inflammatory analgetic raise immunity, the activity that endocrine regulation and liver enzyme lure, strengthen function of detoxification, the effect of stablizing lysosome and mitochondrial membrane promotes substance metabolism from bile secretion, activating complement, give birth to interferon, improve the attack of cellular immunization, to reach the removing hepatitis B virus to target cell, the purpose of liver cell regeneration is feared quinone owing to contain Rhizoma Polygoni Cuspidati in the medicine, thereby to bone marrow depression due to the hepatitis B virus and cause platelet, leukopenia person curative effect is more remarkable, therefore, and reasonable recipe of the present invention, curative effect is affirmed, and oral dose is few.

Claims (2)

1, a kind of effective ingredient with vegetable crude drug is a raw material, and the Chinese patent medicine compositions capsule for curing hepatitis of making that is used for the treatment of chronic hepatitis is characterized in that:

(1). principal agent is a stem and leaf of Radix Ginseng total saponins, and silymarin, Rhizoma Polygoni Cuspidati are feared quinone, oleanolic acid;

(2). stem and leaf of Radix Ginseng total saponins is 40～44% in the patent medicine, and silymarin is 29～32%, and Rhizoma Polygoni Cuspidati is feared quinone 16～18%, oleanolic acid 9～11%.

(3). add the capsule of making after filler mixes.

2, Chinese patent medicine compositions capsule for curing hepatitis according to claim 1 is characterized in that described filler is a Tremella powder.