CN1814249B - Chinese medicine composition for treating hepatitis and preparation method thereof - Google Patents

Abstract

The invention discloses a medicinal combination for curing hepatitis B and the preparing method thereof, composed of Herba Hyperici Japonici, Whitebackleaf Mallotus Root, Danshen, Membranous Milkvetch Root, Turmeric Root-tuber, White Peony, Vietnamese Sophora Root, Chinese Thorowax Root, etc. And the preparing method includes the following steps of: weighing all raw materials in proportion, crushing and grinding them into powders, decocting with water twice, 3 hours for the first time, and 2 hours for the second time, filtering, concentrating the filtrate into plaster, drying, crushing and pass through 100-mesh sieve, mixing uniformly, wetting, softening, forming into a mass and taking out the mass, and making the mass into granular infusion. It is to be orally taken, convenient to use, tasting good, easy to be accepted by patients, having characters of strong effect of prohibiting and eliminating hepatitis B, Yin conversion rate of HBsAg up to above 55% within 6 months, and low curing expenses, able to save the expenses by above 66%.

Description

A kind of Chinese medicine composition for the treatment of hepatitis B and preparation method thereof

Technical field

The present invention relates to drug world, specifically a kind of is the Chinese medicine composition and the application thereof of the treatment hepatitis B of main component with Chinese medicine.

Background technology

Hepatitis is a kind of global distribution and the great disease of social harm.Not exclusively investigate according to World Health Organization (WHO), the whole world has more than 100 ten thousand people to die from hepatitis disease every year.China now is high incidence of hepatitis, and hepatitis b virus infection ratio is 42%-80% among the national crowd, and wherein has 1/4 hepatitis B virus carriers finally to develop into liver cirrhosis and primary hepatocarcinoma approximately, accounts for the over half of world's hepatitis B patient.Hepatitis B is that a kind of many internal organs are got involved simultaneously, and the function performance is low, the pathogenesis complexity, and the course of disease is long, easily repeatedly, the disease that refractory is healed.Modern medicine does not still have specific medicament to the treatment of hepatitis B, though existing have antiviral agents such as interferon, vidarabine and acycloguanosine that certain curative effect is arranged, it has strict indication, take expensive, side effect is more, and most patients are difficult to bear, difficult the popularization.

At present, the Chinese traditional treatment acute or chronic hepatitis B has been obtained gratifying progress.For example, at the raising non-specific cell immunologic function of regulating and control immunology, reduction autoimmune response and removing immune complex; In the promotion cell growth that improves aspect the hepatic pathology, fibrosis: improving falling enzyme, jaundice eliminating, improve albumen and collagenic supersession aspect the liver function; Aspect screening anti-hepatitis virus Chinese herbal medicine, entered and studied in the clinical body etc., but all do not had breakthrough achievement from the laboratory in vitro study.YIGANNING CHONGJI, the hepatitis B of clinical practice now separated and gathered new drugs such as capsule, Herba Abri pill, YIGAN SAN, and effect of its treatment hepatitis B is still unsatisfactory, its definite curative effect still need further research and checking.Particularly the treatment of chronic hepatitis B is difficult especially, and its key is to suppress and to remove hepatitis B virus fully; Adjust immunity of organism, protection hepatocyte, blocking-up chronicity (hepatic fibrosis), still do not have desirable medicine so far.Long for to solve above-mentioned contradiction at one stroke, medical circle is in theory still all had any problem in practice both at home and abroad at present.Therefore, how to seek reliable medicine of determined curative effect and therapeutic regimen and be still the difficult problem that the clinicist suddenly expects solution.

Summary of the invention

Purpose of the present invention is exactly in order to address the above problem, and providing a kind of is having inhibition and removing hepatitis B virus, adjustment immunity of organism of main component with Chinese medicine; Protection hepatocyte, blocking-up fibrosis effect are to treatment chronic hepatitis B obvious results Chinese medicine composition and application thereof.

Purpose of the present invention can take following method to realize:

A kind of Chinese medicine composition for the treatment of hepatitis B is characterized in that it is that component is formed or made active component and pharmaceutically acceptable additives are formed or make active component and pharmaceutically acceptable additives are formed by the alcohol extract of following main materials by the water extract of following main materials by following main materials:

Herba Hyperici Japonici 300～600 weight portions, Folium Malloti Apeltae 300～450 weight portions, Radix Salviae Miltiorrhizae 300～450 weight portions,

The Radix Astragali 300～450 weight portions, the Radix Paeoniae Alba 300～450 weight portions, Radix Curcumae 180～300 weight portions,

Radix Sophorae Tonkinensis 180～300 weight portions, Radix Bupleuri 120-180 weight portion.

Described a kind of preparation method for the treatment of the Chinese medicine composition of hepatitis B comprises the steps;

Take by weighing each raw material by formula proportion, said medicine is pulverized ground into coarser powder, decocting secondary, 3 hours for the first time, 2 hours for the second time, to filter, filtrate is condensed into thick casual cream, drying, pulverized 100 mesh sieves, mixing, moistening, soften, take out when forming agglomerate, make dissolved granule.

Purpose of the present invention can also take following method to realize;

Its formula optimization is:

Herba Hyperici Japonici 450 weight portions, Folium Malloti Apeltae 400 weight portions, Radix Salviae Miltiorrhizae 400 weight portions, the Radix Astragali 400 weight portions,

The Radix Paeoniae Alba 400 weight portions, Radix Curcumae 250 weight portions, Radix Sophorae Tonkinensis 250 weight portions, Radix Bupleuri 150 weight portions.

Described pharmaceutically acceptable additives are following one or more: ethylparaben, tartaric acid, citric acid, sodium bicarbonate, lecithin, sodium lauryl sulphate, glycerol, gelatin, Polyethylene Glycol, glycerol monolaurate (8elucire44/14), propylene glycol, dextrin, dried starch.

Its dosage form can be a said dosage form on any pharmaceutics, and as effervescent granule electuary, capsule, tablet etc.: described capsule can be common capsule, effervescent capsule or other various suitable capsules; Described tablet can be common tablet, effervescent tablet, dispersible tablet or other various suitable tablets, can be with suitable coating material coating also coating not; Preferred effervescent granule electuary.

Medicine of the present invention is through clinical trial certificate, and Herba Hyperici Japonici, Folium Malloti Apeltae, Radix Salviae Miltiorrhizae, Radix Sophorae Tonkinensis, Radix Bupleuri have obvious inhibition and scavenging action to hepatitis B virus; Radix Salviae Miltiorrhizae, Radix Curcumae, the Radix Paeoniae Alba, Radix Sophorae Tonkinensis, Radix Bupleuri have blood circulation promoting and blood stasis dispelling, detumescence removing heat from blood, heat clearing and damp drying, promoting QI circulation for relieving depression, strengthening the spleen to promote digestion also can improve the cell oxidation resistance, alleviates the membrane lipid peroxidating, the stabilized cell structure, reduce erythrocyte aggregation, remove small thrombosis, improve liver microcirculation, accelerate hepatocellular oxygen supply, accelerate the drainage of metabolite, recover hepatocellular homergy and blood supply, promote the reparation and the hepatocellular regeneration of hepatic injury; The Radix Astragali, the strong board of Radix Paeoniae Alba QI invigorating, liver and kidney tonifying, the scalable immune function of human body, enhancing immunity helps removing hepatitis B virus, and can improve blood oxygen carrying capacity; It has that good replenishing QI to invigorate the spleen, the kidney invigorating nourishing the liver, removing heat from blood are separated and gathered, promoting QI circulation for relieving depression the medicine of the present invention that above-mentioned many medicines share and make; strengthening the spleen to promote digestion; suppress and remove the effect of hepatitis B virus, adjustment antibody mediated immunity, protection hepatocyte, prevention fibrosis, especially very remarkable to treatment chronic hepatitis B curative effect.

The specific embodiment

Describe implementation of the present invention in detail below in conjunction with embodiment,

Embodiment 1;

Each method of the system of dissolved granule of the present invention:

Take by weighing each raw material; Herba Hyperici Japonici 50 grams, Folium Malloti Apeltae 400 grams, Radix Salviae Miltiorrhizae 400 grams, the Radix Astragali 400 grams, the Radix Paeoniae Alba 400 grams, Radix Curcumae 250 grams, Radix Sophorae Tonkinensis 250 grams, Radix Bupleuri 150 grams.

Said medicine pulverized grinds into coarser powder, the decocting secondary, 3 hours for the first time, 2 hours for the second time, filter, filtrate is condensed into thick paste, drying was pulverized 100 mesh sieves, mixing, moistening, soften, take out when forming agglomerate, make dissolved granule.

In like manner, press the method for embodiment 1, add suitable additives and can be made into tablet or capsule etc.

Preparation of the present invention is brown granular or grey black tablet or capsule, the tool aromatic odor, and mildly bitter flavor acid, nontoxic, be pure Chinese medicine compound granule or tablet or capsule,

Application examples 1:

Relatively its situation is as follows for the clinical treatment of treatment group of the present invention and matched group:

(1) case is selected and grouping

With reference to the diagnosis mark of national viral hepatitis meeting in 1978, accept the chronic active hepatitis patient for medical treatment.Be divided into two groups at random; Medicine treatment group of the present invention (388 example) and Herba Abri pill, compound Herba Sedi, silybin are matched group (166 example).Male 320 examples in the treatment group of the present invention, women 68 examples.Course of disease 1-3,

(2) therapeutic scheme

By the medicine of the embodiment of the invention 1 preparation, oral, every day three times.3 months is a course of treatment.Matched group compound Herba Sedi, silybin, Herba Abri pill be dosage treatment 3 months in accordance with regulations.

Before the patient treatment all through health check-up and liver function, protein electrophoresis, HbsAe, anti--HBs, HbeAg comprehensively, resist-HBe, resist-HBC,, the inspection of lgG, lgA, lgU.Every first quarter moon, was checked once, and is pressed the observed and recorded table record February to January in the process.

(3) criterion of therapeutical effect.

Produce effects: transference cure, liver spleen in various degree dwindle or constant, liver function normal substantially (SGPT reaches normal value, promptly improves reitman-frankel method in 25 μ, other TIT, ZnTT, r ball dawn be white descend more obvious).

Take a turn for the better: symptom is clearly better, and sign makes moderate progress or be constant, and liver function has improvement (SGPT descends more than 50 than treatment is preceding) in various degree.

Invalid, do not reach above standard person.

4, therapeutic outcome is as follows:

Characteristics of the present invention are:

1. be the All Pure Nature pharmaceutical preparation, do not have strict indication and toxic and side effect;

2. the employing peroral dosage form is easy to use, and mouthfeel is good, and the patient easily accepts;

3. inhibition and the effect of removing hepatitis B are strong, and 6 months HBsAg negative conversion rates of medication can reach more than 55%;

4. medical expense is low, but than the conventional therapy cost saving more than 66%;

5. be easy to apply.

Claims (7)

1. Chinese medicine composition for the treatment of hepatitis B, it is characterized in that: it makes active component by the water extract of following raw materials according and pharmaceutically receptible additives are formed, the weight portion of each raw material is: Herba Hyperici Japonici 300～600 weight portions, Folium Malloti Apeltae 300～450 weight portions, Radix Salviae Miltiorrhizae 300～450 weight portions, the Radix Astragali 300～450 weight portions, the Radix Paeoniae Alba 300～450 weight portions, Radix Curcumae 180～300 weight portions, Radix Sophorae Tonkinensis 180～300 weight portions, Radix Bupleuri 120～180 weight portions.

2. a kind of Chinese medicine composition for the treatment of hepatitis B according to claim 1, it is characterized in that: the weight portion of described each raw material is: Herba Hyperici Japonici 450 weight portions, Folium Malloti Apeltae 400 weight portions, Radix Salviae Miltiorrhizae 400 weight portions, the Radix Astragali 400 weight portions, the Radix Paeoniae Alba 400 weight portions, Radix Curcumae 250 weight portions, Radix Sophorae Tonkinensis 250 weight portions, Radix Bupleuri 150 weight portions.

3. a kind of Chinese medicine composition for the treatment of hepatitis B according to claim 1 is characterized in that: described pharmaceutically acceptable additives are following more than one: ethylparaben, tartaric acid, citric acid, sodium bicarbonate, lecithin, sodium lauryl sulphate, glycerol, gelatin, Polyethylene Glycol, glycerol monolaurate, propylene glycol, dextrin, dried starch.

4. a kind of preparation method for the treatment of the Chinese medicine composition of hepatitis B as claimed in claim 1, it is characterized in that comprising the steps: taking by weighing by weight each raw material, said medicine is pulverized ground into coarser powder, decocting secondary, 3 hours for the first time, 2 hours for the second time, to filter, filtrate is condensed into thick paste, dry, pulverized 100 mesh sieves, mixing, moistening, soften, take out when forming agglomerate, make dissolved granule.

5. a kind of Chinese medicine composition for the treatment of hepatitis B according to claim 1 is characterized in that: its dosage form is effervescent granule electuary, capsule or tablet.

6. a kind of Chinese medicine composition for the treatment of hepatitis B according to claim 5 is characterized in that: described capsule is the effervescent capsule.

7. a kind of Chinese medicine composition for the treatment of hepatitis B according to claim 5 is characterized in that: described tablet is effervescent tablet or is dispersible tablet, with suitable coating material coating.