CN1128634C

CN1128634C - Hepatitis B recuperating medicine granule

Info

Publication number: CN1128634C
Application number: CN01117623A
Authority: CN
Inventors: 薛志祥
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-04-28
Filing date: 2001-04-28
Publication date: 2003-11-26
Anticipated expiration: 2021-04-28
Also published as: CN1347715A

Abstract

The present invention relates to a pure Chinese medicinal preparation for treating hepatitis B, more specifically a hepatitis B recuperating granule. The medicinal preparation is preferably prepared from 100 wt% of ginseng, 100 wt% of astragalus root, 100 wt% of cyrtomium fortunei, 100 wt% of paris rhizome, 100 wt% ofbarbat skullcap, 100 wt% of isatis root, 50 wt% of red peony root, 50 wt% of cortex moutan, 50 wt% of artemisia capillaris, 50 wt% of tuckahoe, 50 wt% of red sage root, 50 wt% of achyranthes root, 50 wt% of rhubarb, 50 wt% of carapax trionycis, 50 wt% of prism tuber, 50 wt% of zedoary rhizome, 50 wt% of tortoise plastron, 50 wt% of wolfberry fruit, 50 wt% of white peony root, 50 wt% of bupleurum root, 50 wt% of dragon blood, 50 wt% of notoginseng, 50 wt% of white atractylodes rhizome and 50 wt% of cordyceps according to a specific technology. The granule used for treating hepatitis B has the functions of killing hepatitis B viruses, adjusting immune functions, strengthening and consolidating body resistance, resisting hepatic fibrosis, inversing hepatic fibrosis, preventing liver cirrhosis development, strengthening bodies without remaining evil, eliminating evil without hurting the bodies, promoting blood circulation, removing blood stasis, clearing away heat, removing toxicity, increasing blood flow in the liver and promoting the restoration of damaged liver cells.

Description

A kind of pure Chinese medicinal preparation for the treatment of hepatitis B

The present invention is a kind of treatment hepatitis B, prevents hepatic fibrosis and the pure Chinese medicinal preparation that develops to liver cirrhosis hepatocarcinoma aspect.

The World Health Organization (WHO), on May 1st, 1998 releasing bulletin, existing 1.7 hundred million people in the whole world are infected by hepatitis C virus (HCV).Wherein, most is that hepatitis B, hepatitis C patient can develop into chronic hepatopathy, add the chronic hepatopathy that other reason causes, its number of patients is very huge, and present unique interferon therapy that gains public acceptance, because the high and unavoidable toxicity of its medicine valency has limited its popularization and application, thereby turn to the anti-hepatic fibrosis new product of Chinese medicine of developing relative low price, efficient, nontoxic (low toxicity).

" a kind of medicine for the treatment of hepatitis B " is my many decades, through the length of various schools of thinkers, gets many work elite, research repeatedly, and theoretical practice filters out more than 20 kind of Chinese herbal medicine meticulously from hundreds of Chinese herbal medicine, processing rationally, formulated pure Chinese medicinal preparation.

Radix Ginseng, the Radix Astragali, Cordyceps have the effect of activate immunity function in the side, participate in a series of biochemical reactions in vivo, and obvious dual regulation is arranged, thereby strengthen the human righteousness and strengthening vital QI to eliminate pathogenic factors, rebuild and enhancing human immune system function.Not only can strengthen healthy energy, improve immunologic function and body resistance against diseases, promote virus sweep, produce interferon, and anti-hepatic fibrosis improves microcirculation in the body, strengthen T cell ratio, promote liver cell regeneration and antibody to generate.Rhizoma Osmundae, Rhizoma Paridis, Radix Isatidis, Herba Scutellariae Barbatae have HBV had and suppress killing action more by force, and Radix Paeoniae Rubra, Cortex Moutan can strengthen the liver blood flow amount, promote impaired hepatocyte to repair, and suppress and eliminate the effect of immune complex.Herba Artemisiae Scopariae, Poria heat-clearing and dampness-resolving, Radix Salviae Miltiorrhizae, Radix Achyranthis Bidentatae have blood circulation promoting and blood stasis dispelling, blood-supplementing blood-nourishing effect.Radix Et Rhizoma Rhei, Bie Jia, rhizoma sparganic, Rhizoma Curcumae have hard masses softening and resolving retraction function of liver and spleen.Carapax et Plastrum Testudinis, Fructus Lycii nourishing the liver and kidney, essence-replenishing and marrow-strengthening, Radix Bupleuri depressed liver-energy dispersing and QI regulating, invigorating the spleen and regulating the stomach.Radix Notoginseng, Sanguis Draxonis have the effect of blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, blood-nourishing blood-generating.All medicines share, and have the hepatitis B virus of killing, and adjust immunologic function protection hepatocyte, prevent hepatic fibrosis.Clinically be usually used in acute or chronic hepatitis B and the HbsAg carrier also has significant curative effect to liver cirrhosis hepatocarcinoma in addition.

Clinical research:

One, physical data: 100 examples are organized in treatment, matched group 100 examples.Sex and age, a kind of pure Chinese medicinal preparation group male 60 examples for the treatment of hepatitis B, women's 40 examples, mean age (X ± S1 year) 32.50 ± 9.50.Matched group: male's 60 examples, women's 40 examples, age (X ± SD year) 31.90 ± 11.45.

Two, hepatopathy typing (seeing Table 1)

Table 1: each group is debated disease typing case

Group	Chronic persistent	Chronic active	The HbsAg carrier
Group	Chronic persistent	Chronic active	The HbsAg carrier	A kind of pure Chinese medicinal preparation for the treatment of hepatitis B	45	40	15
Matched group	40	40	20		45	40	15

Course of disease distribution (seeing Table 2)

Table 2: each organizes course of disease distribution situation (year)

Group	More than half a year	1～	3～	5～	10～	15～
Group	More than half a year	1～	3～	5～	10～	15～	A kind of pure Chinese medicinal preparation for the treatment of hepatitis B	10	30	40	10	5	5
Matched group	9	35	35	11	10	0		10	30	40	10	5	5

Above data show each group sex, age debate disease and debate aspect disease typing similar substantially, diagnostic criteria (with reference to new Chinese medicine clinical research guideline (Ministry of Public Health was specified 1993) P＞0.05 and national viral hepatitis control investigation meeting summary (1991)).

Three, Therapeutic Method:

1, treatment group restrained with a kind of medicine for the treatment of hepatitis B, each 1 generations 10, and is day 3 times, oral;

2, matched group: 0.3g of (1) penta ring glycosides, day 3 times, oral or 75～100 milligrams of intravenous injections every day, 1 time on the 1st.(2) krestin, 1 time 1 bag, day 3 times;

3, the course of treatment: two groups was a course of treatment with 3 months all.

Two groups of patients must note suitable rest, should be association of activity and inertia after sb.'s illness took a favorable turn, and convalescent period increase activity gradually, but should avoid overwork, in order to rehabilitation, during loss of appetite, can advance high protein diet, but should note not hyperphagia, in case fatty liver takes place.Change full diet into after appetite is normal, forbid drinking.

Four, the evaluation criteria course of treatment (the new Chinese medicine clinical research instructs former wealth (1993) and national viral hepatitis to prevent and treat hepatitis control seminar summary (1991)).

(1), the basic healing.

1, HBV active replication index is turned out cloudy, and liver function is normal.

2, hepatomegaly has retraction or stable, no tenderness, percussion pain.

3, subjective symptoms disappears substantially, and the state of an illness is continual and steady.

(2), effective:

1, HBV active replication index titre descends more than 1/2, or liver function is near normal.

2, hepatomegaly is stablized constantly, mild tenderness is arranged, percussion pain.

3, subjective symptoms obviously alleviates but does not still endure hardships tired.

(3), invalid: treatment back lab testing, symptom body card does not all have improvement, even worsens.

Five, therapeutic outcome:

(1), total effects relatively: the basic cure rate 69% of treatment group (a kind of medicine for the treatment of hepatitis B), total effective rate 93%; Matched group is 79%, the two group of P that compares＜0.01, sees Table 4 tables 4: treatment group and matched group general headquarters imitate relatively

Group	The example number	Basic cure rate	Effective percentage	Inefficiency	Total effective rate
Group	The example number	Basic cure rate	Effective percentage	Inefficiency	Total effective rate	The treatment group	100	68％(68)	25％(25)	7％(7)	93％(93)
Matched group	100	6％(6)	73％(73)	21％(21)	79％(79)	The treatment group	100	68％(68)	25％(25)	7％(7)	93％(93)

P ＜0.01 ＜0.01 ＜0.01 ＜0.01

Therefore, medicine of the present invention is to be the Chinese patent medicine that feedstock production forms with following pharmaceutical composition:

Radix Ginseng 100-200 gram, Radix Astragali 100-200 gram, Rhizoma Osmundae 100-200 gram, Rhizoma Paridis 100-200 gram, Herba Scutellariae Barbatae 100-200 gram, Radix Isatidis 100-200 gram, Radix Paeoniae Rubra 50-100 gram, Cortex Moutan 50-100 gram, Herba Artemisiae Scopariae 50-100 gram, Poria 50-100 gram, Radix Salviae Miltiorrhizae 50-100 gram, Radix Bupleuri 50-100 gram, Radix Achyranthis Bidentatae 50-100 gram, Radix Et Rhizoma Rhei 50-100 gram, other first 50-100 gram, rhizoma sparganic 50-100 gram, Rhizoma Curcumae 50-100 gram, Carapax et Plastrum Testudinis 50-100 gram, Fructus Lycii 50-100 gram, Radix Paeoniae Alba 50-100 gram, Sanguis Draxonis 50-100 gram, Radix Notoginseng 50-100 gram, Rhizoma Atractylodis Macrocephalae 50-100 gram, Cordyceps 50-100 gram.

The preferred weight proportioning of pharmaceutical composition of the present invention is:

Radix Ginseng 100 restrains, the Radix Astragali 100 restrains, Rhizoma Osmundae 100 restrains, Rhizoma Paridis 100 restrains, Herba Scutellariae Barbatae 100 restrains, Radix Isatidis 100 restrains, Radix Paeoniae Rubra 50 restrains, Cortex Moutan 50 restrains, Herba Artemisiae Scopariae 50 restrains, Poria 50 restrains, Radix Salviae Miltiorrhizae 50 restrains, Radix Achyranthis Bidentatae 50 restrains, Radix Et Rhizoma Rhei 50 restrains, other first 50 restrains, rhizoma sparganic 50 restrains, Rhizoma Curcumae 50 restrains, Carapax et Plastrum Testudinis 50 restrains, Fructus Lycii 50 restrains, the Radix Paeoniae Alba 50 restrains, Radix Bupleuri 50 restrains, Sanguis Draxonis 50 I, Radix Notoginseng 50 restrain, the Rhizoma Atractylodis Macrocephalae 50 restrains, Cordyceps 50 restrains.

Pharmaceutical composition of the present invention can be prepared into any pharmaceutical preparation that is suitable for using clinically according to conventional formulation technology.For example: tablet, powder, pill, granule, capsule, oral liquid any.

Process for preparing medicine of the present invention is:

1, selected crude drug: selected high-quality Chinese crude drug, to remove impurity, and differentiate and the run-of-the-mill check by pharmacopeia regulation, defective medical material such as of poor quality, as to go bad, damage by worms, go mouldy must not use.

2; polish: with Radix Ginseng; the Radix Astragali; Rhizoma Osmundae; Rhizoma Paridis; Herba Scutellariae Barbatae; Radix Isatidis; Radix Paeoniae Rubra; Cortex Moutan; Herba Artemisiae Scopariae; Poria; Radix Salviae Miltiorrhizae; Radix Achyranthis Bidentatae; Radix Et Rhizoma Rhei; other first; rhizoma sparganic; Rhizoma Curcumae; Carapax et Plastrum Testudinis; Fructus Lycii; the Radix Paeoniae Alba; Radix Bupleuri; the Rhizoma Atractylodis Macrocephalae; Cordyceps adds 8 times of water loggings or does not have powder 2～3cm; heating decocts filtered in 2 hours; the merging filtrate low-temperature evaporation; concentrate and reclaim ethanol; revaporization concentrates; putting cold place filtered precipitation in 24 hours fully; the filtrate low-temperature evaporation is to dense shape (water content 20%); Radix Notoginseng; Sanguis Draxonis is ground into powder and is blended into; add an amount of excipient mixing, make soft material, move to granulation machine 12 orders and granulate with 70% ethanol; put in the baking oven dry again under the low temperature; remove than fine grained and make evenly, 10 grams are packed, and every gram contains crude drug 2 grams.

Pharmaceutical composition of the present invention has the hepatitis B virus of killing, and adjusts immunologic function, strengthening the body resistance, and anti-hepatic fibrosis promotes the effect that impaired hepatocyte recovers.

Prove that through the zoopery pharmacodynamic study pharmaceutical composition of the present invention has following pharmacological action

One, " a kind of medicine for the treatment of hepatitis B ", to the effect of DHB:

Get 30 of ducklings respectively, give every duckling lumbar injection DHB, cause the duck hepatitis B virus infection model, make liver form obvious damage, observe the antivirus action of each group then, liver function histopathology situation of change.

(1), " a kind of medicine for the treatment of hepatitis B " is to the effect of DHB.

1, antivirus test: (1) extracorporeal antivirus effect result of the test.

Each winding kind mixed liquor, blood sampling after 7 days, detect the positive incidence rate of DHBSAg in the Sanguis Anas domestica with monoclonal antibody double fastener heart ELISA, 3 groups are 100% (8/8), and medication detects a kind of medicine group for the treatment of hepatitis B, krestin group after 42 days, the normal saline group, the DHBSAg positive rate is respectively 50% (3/6), and 66.7% (4/6), 100% (6/6).A kind of medicine group DHBSAg positive rate for the treatment of hepatitis B is starkly lower than the krestin group, the normal saline group after showing medicine.(2) " a kind of medicine for the treatment of hepatitis B " carries the influence of DHBSAg to duckling.

Experimental technique is the same, detects a kind of medicine small dose group for the treatment of hepatitis B in 42 days behind the medicine, a kind of heavy dose of group of medicine for the treatment of hepatitis B, and the heavy dose of DHBSAg positive rate of krestin group is starkly lower than all the other two groups.More than a kind of medicine for the treatment of hepatitis B of explanation has anti-HBV effect.

Two, to the influence of liver function:

Each looks into the clear middle glutamate pyruvate transaminase (ALT) of Sanguis Anas domestica during organizing medication front and back difference, alkali phosphatase (ALP), total bilirubin (TBIL), a kind of medicine small dose group of hepatitis B, heavy dose of group for the treatment of of inspection in 42 days behind its Chinese medicine, the Serum ALT of krestin group, AST, ALP, TBIL, three groups all have decline in various degree, and descend the most obvious with a kind of heavy dose of group of medicine for the treatment of hepatitis B.

Three, tissue slice check result:

A kind of large and small two dosage groups of medicine for the treatment of hepatitis B, the DHBSAg of krestin group is positive, and the duck liver lesion tissue is similar to model group, but the significantly improvement of the male duck liver tissue of DHBSAg, even complete obiteration, be tending towards normal.A kind of large and small dosage group of medicine for the treatment of hepatitis B is better than model group and krestin group, can produce the interferoid effect behind its pharmacological action explanation clothes, and anti-hepatic fibrosis.

Just hinders because of chronic hepatitis B always belongs to evil the Sheng, and be its pathological characteristic with " stasis of blood poison " pent-up especially, so the excess syndrome that hot and humid ecchymosis is tied mutually, treatment ought eliminating evilly be main, and the eliminating evil meaning of promptly residing and setting upright is treated and focused on that Qinghua is damp and hot, hepatic toxicity quelling, cooling blood and removing stasis.A kind of medicine for the treatment of hepatitis B of zoopery proof to external, the in vivo test of dhbv dna, all obviously plays inhibitory action.Clinical practice shows, along with sb.'s illness took a favorable turn, and the disappearance of primary symptom and alleviate HBEA-g, HBSAg negative conversion rate 6%, 38%, apparently higher than Chinese medicine and western medicine, the prompting heresy is changeed then eutopic reduction.But then, hot and humid ecchymosis is handed over knot, must consume impairing the liver the moon for a long time, undermines temper, the syndrome of intermingled deficiency and excess of performance deficient vital QI leading to lingering of pathogen, and treatment ought be taken good care of the liver spleen again, holds concurrently with Qinghua stasis of blood poison.Animal and clinical experiment prompting; after using a kind of medicine for the treatment of hepatitis B; it is normal that ALT, AST, Y-GT, TBIL all recover rapidly; histological observation; liver organization and primary cellular defect apparition are lighter than matched group; illustrate that taking a kind of its pharmacological action of medicine for the treatment of hepatitis B can produce the interferoid effect; thereby reach anti-hepatic fibrosis; explanation has good protective action to liver; regulate the effect of immunologic derangement simultaneously in addition; can the enhancing body resistance against diseases, confirm to set upright and eliminating evil mutuality of interest.

Embodiment:

Prescription: Radix Ginseng 100 grams, the Radix Astragali 100 grams, Rhizoma Osmundae 100 grams, Rhizoma Paridis 100 grams, Herba Scutellariae Barbatae 100 grams, Radix Isatidis 100 grams, Radix Paeoniae Rubra 50 grams, Cortex Moutan 50 grams, Herba Artemisiae Scopariae 50 grams, Poria 50 grams, Radix Salviae Miltiorrhizae 50 grams, Radix Achyranthis Bidentatae 50 grams, Radix Et Rhizoma Rhei 50 grams, other first 50 grams, rhizoma sparganic 50 grams, Rhizoma Curcumae 50 grams, Carapax et Plastrum Testudinis 50 grams, Fructus Lycii 50 grams, the Radix Paeoniae Alba 50 grams, Radix Bupleuri 50 grams, Sanguis Draxonis 50 grams, Radix Notoginseng 50 grams, the Rhizoma Atractylodis Macrocephalae 50 grams, Cordyceps 50 grams.

Technology:

Defective medical materials such as 1, crude drug check after cleaning, is removed impurity, and differentiates by the pharmacopeia regulation, and is of poor quality, as to go bad, damage by worms, go mouldy must not use.

2; get and handle clean medical material; take by weighing weight by recipe quantity; be ground into coarse powder and add 8 times of water loggings or soak powder 2～3cm, heating decocts filtered in 2 hours, and supernatant inclines; steam to slip and reclaim ethanol; revaporization concentrates puts the filtration in 24 hours of cold place, merging filtrate, low-temperature evaporation; concentrate half amount of original volume; add 95% ethanol equivalent mixing and spend the night and make sedimentation, the supernatant that inclines steams to slip and reclaims ethanol; revaporization concentrates to be put cold place and precipitation was filtered fully in 24 hours; the filtrate low-temperature evaporation is to dense shape (water content 20%), Radix Notoginseng; Sanguis Draxonis is ground into powder and is blended into, and adds an amount of excipient mixing; make soft material with 70% ethanol; move to granulation machine 12 orders and granulate, put in the baking oven dryly again under the low temperature, remove than fine grained and make evenly; 10 grams are packed, and every gram contains crude drug 2 grams.

Claims

1, a kind of medicine for the treatment of hepatitis B, it is characterized in that it is made by the following weight proportion raw material: Radix Ginseng 100-200 gram, Radix Astragali 100-200 gram, Rhizoma Osmundae 100-200 gram, Rhizoma Paridis 100-200 gram, Herba Scutellariae Barbatae 100-200 gram, Radix Isatidis 100-200 gram, Radix Paeoniae Rubra 50-100 gram, Cortex Moutan 50-100 gram, Herba Artemisiae Scopariae 50-100 gram, Poria 50-100 gram, Radix Salviae Miltiorrhizae 50-100 gram, Radix Achyranthis Bidentatae 50-100 gram, Radix Et Rhizoma Rhei 50-100 gram, Carapax Trionycis 50-100 gram, rhizoma sparganic 50-100 gram, Rhizoma Curcumae 50-100 gram, Carapax et Plastrum Testudinis 50-100 gram, Fructus Lycii 50-100 gram, Radix Paeoniae Alba 50-100 gram, Radix Bupleuri 50-100 gram, Sanguis Draxonis 50-100 gram, Radix Notoginseng 50-100 gram, Rhizoma Atractylodis Macrocephalae 50-100 gram, Cordyceps 50-100 gram.

2, a kind of medicine for the treatment of hepatitis B according to claim 1, wherein the weight proportion of each raw material is: Radix Ginseng 100 grams, the Radix Astragali 100 grams, Rhizoma Osmundae 100 grams, Rhizoma Paridis 100 grams, Herba Scutellariae Barbatae 100 grams, Radix Isatidis 100 grams, Radix Paeoniae Rubra 50 grams, Cortex Moutan 50 grams, Herba Artemisiae Scopariae 50 grams, Poria 50 grams, Radix Salviae Miltiorrhizae 50 grams, Radix Bupleuri 50 grams, Radix Achyranthis Bidentatae 50 grams, Radix Et Rhizoma Rhei 50 grams, other first 50 grams, rhizoma sparganic 50 grams, Rhizoma Curcumae 50 grams, Carapax et Plastrum Testudinis 50 grams, Fructus Lycii 50 grams, the Radix Paeoniae Alba 50 grams, Sanguis Draxonis 50 grams, Radix Notoginseng 50 grams, the Rhizoma Atractylodis Macrocephalae 50 grams, Cordyceps 50 grams.

3, a kind of medicine for the treatment of hepatitis B according to claim 1 and 2, the dosage form that it is characterized in that this medicine are any of tablet, powder, pill, granule, capsule, oral liquid.