CN1106690A

CN1106690A - Medicine of curing hepatitis

Info

Publication number: CN1106690A
Application number: CN 94118275
Authority: CN
Inventors: 张俊富
Original assignee: Tianjin No1 Hospital
Current assignee: Tianjin No1 Hospital
Priority date: 1994-11-19
Filing date: 1994-11-19
Publication date: 1995-08-16
Anticipated expiration: 2014-11-19
Also published as: CN1056755C

Abstract

The said medicine for hepatitis is prepared with Chinese medicinal material including Epimedium, Polygonum cuspidatum. Paeonia lactiflora, tararacum, Astragalus, etc. It is oral prepn prepared via extraction and concentration. The said medicine prepn has excellent curative effect, i.e., ALT return-to-normal rate being 51.6% and 59.4% for chronic persisting type hepatitis and chromic motive hepatitis respectively, AST return-to-normal rate being 48.4% and 62.3% respectively, and inhibitation rate of HBV-DNA and DNA-P being 76.1% and 78.4% respectively.

Description

Medicine of curing hepatitis

What the present invention relates to is that a kind of application drug matching forms, the pharmaceutical formulation of treatment hepatitis and contain the product of this prescription.

Hepatitis B is the viral infectious of serious harm human body health, because the hepatitis B virus range of infection is wide, the easy infection number is many, wherein the hepatitis patient of 10-20% is a chronic hepatitis B, and the Drug therapy difficulty of chronic active hepatitis is big, and quite a few people will be gradually transformed into the trend of liver cirrhosis, its transformation time is that 3-10 does not wait, therefore, the treatment of chronic hepatitis B, not only to suppress virus in vivo duplicate propagation, eliminate its virus, also will recover the normal function of its liver, human body immunity improving could be blocked the badness come-off that liver cirrhosis appears in body.China adopts prescription and the medicine a lot of decoct and the powders as CN1065593A, the spirit of hepatitis B specially good effect of Chinese herbal treatment hepatitis B; The production method of CN1060608A hepatitis record and CN85100392A extract the method for treatment medicine for curing hepatitis from Radix Sophorae Tonkinensis, all have their own characteristics each, but clinical case is observed and there is certain weakness in the clinical practice result, mainly is to the inhibition of hepatitis B virus and removes undesirablely, and curative effect is not high.Existing market product sold polyporusum bellatus treatment hepatitis B, the HBeAg negative conversion rate is 34.2%, and doing well,improving and SGPT normalization rate are 12.8%, 35.1%.And bifendate is used for the chronic hepatitis patient, and the ALT normalization rate is 77.4%, but the knock-on rate of ALT is higher, drug withdrawal after 3 months ALT knock-on rate reach 30-50%, and other liver function index is not had obvious improvement, clinical practice is subjected to great restriction like this.

Also has commercially available hepatitis spirit (Radix Sophorae Tonkinensis) injection, need injection every day, and the HBeAg negative conversion rate is 24%, DNA-P negative conversion rate 24.19%, total effective rate are 46.4%, because the sick particularity of planting of hepatitis, the pharmaceutical effectiveness of clinical practice at present is undesirable, the patient more is badly in need of wanting the curative effect height, and toxicity is low, oral new medicine easy to use.

Clinical practice situation according to the present world, state's internal therapy hepatitis medicament, summed up the sick cause of disease characteristics of planting of hepatitis, summed up effective prescription for the treatment of hepatitis for many years, systematically investigated the peroral dosage form that the compatibility of Chinese crude drug medicine prescription and production technology and optimal clinical are used.

The purpose of this invention is to provide and a kind ofly can improve liver function fast, improve the hepatic pathology performance, adjust immunity of organism, eliminate hepatitis B virus, improve the active drug of the treatment hepatitis B of negative conversion rate.

The present invention is in line with the heat-clearing and toxic substances removing of the traditional Chinese medical science, and the principle of dispersing the stagnated live-QI to relieve the stagnation of QI, conditioning liver stomach, nourishing the liver and kidney, blood circulation promoting and blood stasis dispelling is carried out composition of prescription.Medicine of the present invention contains in parts by weight: Herba Epimedii 10-50 part, Rhizoma Polygoni Cuspidati 5-60 part, Radix Paeoniae Rubra 6-120 part, Herba Taraxaci 10-120 part, Radix Astragali 10-150 part, Radix Et Rhizoma Rhei 5-10 part, Ganoderma 6-30 part, Fructus Ligustri Lucidi 6-45 part, root of subprostrate sophora 5-15 part, Rhizoma Smilacis Glabrae 10-100 part.

Medicine of the present invention is to handle, batching, extract, concentrate (unfinished work check) and the oral formulations made through raw material.Promptly can be: tablet, electuary, capsule, oral liquid, syrup etc. keep the oral formulations of physiology drug effect.

Embodiment 1(low dosage)

With 1 grammes per square metre is 1 part, and its content is: Herba Epimedii 10 grams, Rhizoma Polygoni Cuspidati 10 grams, Radix Paeoniae Rubra 10 grams, Herba Taraxaci 10 grams, the Radix Astragali 10 grams, Radix Et Rhizoma Rhei 5 grams, Ganoderma 10 grams, Fructus Ligustri Lucidi 8 grams, root of subprostrate sophora 5 grams, Rhizoma Smilacis Glabrae 10 grams.

Above medical material is through following PROCESS FOR TREATMENT:

(1) with the Diluted Alcohol 70-85% lixiviate of Ganoderma, Herba Epimedii, Rhizoma Smilacis Glabrae, extracting solution merges.

(2) with Herba Taraxaci, Rhizoma Polygoni Cuspidati, the Radix Astragali, root of subprostrate sophora, Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Et Rhizoma Rhei, add decocting in water, the water extract merges.

(3) will merge with the water extract behind the extracting solution decompression recycling ethanol in (1).Concentrating under reduced pressure becomes thick paste.

(4) with condensed cream oven dry in (3), pulverizing again, cross 80 mesh sieves, is wetting agent with 60% ethanol, is controlled to granule, and oven dry by 20 mesh sieves, is made electuary again, every bag 10 gram, 1 bag/time/day.

(5), be packaged into 10 gram/bags with (4) small particles electuary; Or incapsulate, can be made into every capsules and contain 0.5 gram dose, every day three times, each 6.

(6) or with the thick paste pressing tablet technology of (4), be pressed into 0.5 gram/sheet, tablet, four times a day, each 4.

(7) (1), (2) extracting solution are merged, stir evenly, after the standing over night, the leaching supernatant reclaims ethanol, becomes concentrated solution, adds simple syrup, makes syrup preparation.

The 120ml/ bottle, every day secondary, each 20ml.

Embodiment 2(median dose)

Get Herba Epimedii 30 grams, Rhizoma Polygoni Cuspidati 30 grams, Radix Paeoniae Rubra 60 grams, Herba Taraxaci 60 grams, the Radix Astragali 80 grams, Radix Et Rhizoma Rhei 8 grams, Ganoderma 15 grams, Fructus Ligustri Lucidi 30 grams, root of subprostrate sophora 10 grams, Rhizoma Smilacis Glabrae 60 grams.With above medical material, by process in the example 1 make electuary 10 gram/bags or capsule 0.5 gram/, or tablet 0.5 gram/sheet or syrup 120ml/ bottle.

Embodiment 3(high dose)

Get Herba Epimedii 50 grams, Rhizoma Polygoni Cuspidati 60 grams, Radix Paeoniae Rubra 120 grams, Herba Taraxaci 120 grams, the Radix Astragali 150 grams, Radix Et Rhizoma Rhei 10 grams, Ganoderma 30 grams, Fructus Ligustri Lucidi 45 grams, root of subprostrate sophora 15 grams, Rhizoma Smilacis Glabrae 100 grams are made electuary with above medical material by example 1 process, or capsule or tablet or syrup.

Drug standard of the present invention is all according to " Chinese pharmacopoeia requirement.

Medicine of the present invention confirms through clinical application research and experimentation, takes the medicine that contains this prescription, and (DHBV-DNA DNA-P) improves liver function, suppresses hepatitis B virus duplication, the disposable gastric infusion LD of acute toxicity test in mice can to suppress duck liver virus ₅₀＞141.69(crude drug)/and kg, mice maximum tolerated dose＞247.8g(crude drug)/kg, be equivalent to 112.5 times of clinical consumption.The rat long term toxicity test confirms that low dose group is 5.5 times of clinical dosage, 12g/kg, do not have the overt toxicity reaction, nontoxic substantially, high dose group is 11 times of 24g/kg of clinical dosage, no pathology change and influence, are 51.6% through clinical research ALT normalization rate chronic persistent hepatitis, chronic active hepatitis 59.4%; The AST normalization rate is 48.4%, 62.3%; To chronic persistent hepatitis, chronic active hepatitis HBeAg, DNA-P, HBV-DNA, negative conversion rate be respectively 46.2%, 41.2%, 41.1% and 49.1%, 55.6%, 48.5% and the matched group comparing difference remarkable.Duck liver virus HBV-DNA and DNA-P suppression ratio are respectively 76.1% and 78.4%, are better than matched group, and have no side effect.

Claims

1, a kind of medicine for the treatment of hepatitis, it is characterized in that containing Herba Epimedii 10-50 part in parts by weight, Rhizoma Polygoni Cuspidati 5-60 part, Radix Paeoniae Rubra 6-120 part, Herba Taraxaci 10-120 part, Radix Astragali 10-150 part, Radix Et Rhizoma Rhei 5-10 part, Ganoderma 6-30 part, Fructus Ligustri Lucidi 6-45 part, root of subprostrate sophora 5-15 part, Rhizoma Smilacis Glabrae 10-100 part.

2, the medicine of treatment hepatitis according to claim 1, it is characterized in that this medicine be through raw material handle, batching, extract, concentrate (unfinished work check) and oral formulations that having of making treated the hepatitis pharmacodynamics, promptly can be electuary, tablet, capsule, syrup and oral liquid etc.