CN100450511C - Cooperative medicinal compositions comprising Silybum marianum - Google Patents

Abstract

Disclosed is a synergic medicinal composition containing silybin and Chinese medicinal extracts, and its use in preparing medicament for the subsidiary treatment of hepatitis.

Description

The Synergistic medicinal composition that contains silibinin

Invention field

The present invention relates to the Pharmaceutical composition formed by silibinin and Chinese medicine extract, and the purposes of said composition in the medicine of preparation adjuvant treating hepatitis.

Background technology

Hepatitis has multiple sorting technique clinically, classifies as (1) nosetiology: viral hepatitis can be divided into five types is first, second, third, fourth, penta.(2) clinical classification can be divided into following a few type: 1. acute anicteric hepatitis, this is a modal type in the viral hepatitis, see with B-mode, third type, hepatitis D more, general this type of hepatitis clinical symptoms is less, and transaminase's elevated levels is lower, and Histological change is light, mortality rate is lower, but the course of disease can be delayed the long period, and " three is slow " characteristics are arranged, and morbidity is slow, recovery is slow, delay also slow (referring to the long meaning slowly); 2. acute icterohepatitis is less relatively compared with anicteric hepatitis, and the state of an illness is a self limiting often, and how good prognosis is, but minority can develop into hepatitis gravis; 3. chronic hepatitis: relevant experts in 1994 propose the name and the suggestion of chronic hepatitis again, with the cause of disease is the diagnosis name that chronic hepatitis is determined on the basis, simultaneously ordered grade scale, formulated standard by stages according to degree of hepatic fibrosis again according to the downright bad order of severity of hepatitis inflammation; 4. hepatitis gravis can be divided into acute heavy type, severe subacute and chronic heavy type again; 5. cholestatic hepatitis.

Wherein hepatitis B is caused by hepatitis B virus, serves as main a kind of infectious disease that also can cause multiple organ injury with the liver inflammatory lesion.China is the most popular country of hepatitis B, reaches more than 35% some local crowd infection rate, and be the most serious infectious disease of current harm people ' s health.According to investigations, China's hepatitis B patient is about 2,700 ten thousand, and annual New Development patient about 9,000,000.

The hepatitis B clinical manifestation is various, easily develops into chronic hepatitis and liver cirrhosis, and a few peoples finally develop into hepatocarcinoma.Hepatic fibrosis is the total pathological change of many chronic hepatopathy evolutions, and the damage of chronic, persistence is the prerequisite that hepatic fibrosis forms.Cause the factor of hepatic injury a lot,, hepatitis B, liver cirrhosis, take some drugs for a long time and can cause acute and chronic liver injury generally because of factors such as medicine, a large amount of ethanol, allergy cause acute liver damage.By reducing detrimental effect to liver function, can adjuvant treating hepatitis.

The medicine that is used for the treatment of the acute and chronic hepatic injury at present, commonly used have silibinin, a diammonium glycyrrhizinate etc.These chemicalses generally have certain side effect, and cause that therapeutic effect at a specified future date is poor, problem such as Strain produces after drug resistance phenomenon, the drug withdrawal relapse rate height.

The curative effect of Chinese medicine hepatitis B is proved by a large amount of clinical trials.Chinese medicine all can be brought into play curative effect preferably at aspects such as antiviral, adjusting immunity of organisms, protection hepatocyte.But Chinese medicine preparation ubiquity onset at present is slow, needs problems such as life-time service.

Therefore, Western medicine and Chinese Medicine and Clavicular need be got up, i.e. synergism is played in Chinese medicine and western medicine combination, solves the problem that above-mentioned Western medicine and Chinese medicine exist in auxiliary treatment all kinds hepatitis separately, produces synergistic therapeutic effect simultaneously.

Summary of the invention

One object of the present invention is to provide the Pharmaceutical composition of being made up of silibinin and a kind of Chinese medicine extract, and wherein the Chinese medicine extract of said composition prepares according to claim 1 method of Chinese patent CN1232288C, and is as follows:

4 kilograms of Radix Angelicae Sinensis, 4 kilograms of Poria, 4 kilograms of Indigo Naturaliss, 4 kilograms of Alumens, 4 kilograms of the Radixs Astragali, 4 kilograms of Radix Notoginseng, 2 kilograms of Herba Agrimoniaes, 2 kilograms of Herba Epimedii, 2 kilograms of Herba Phyllanthi Urinariaes, 2 kilograms of Herba Hedyotidis Diffusaes, 2 kilograms of Rhizoma Paridis, 2 kilograms of Radix Bupleuri, 2 kilograms of Radix Salviae Miltiorrhizaes, 2 kilograms of Fructus Schisandrae Chinensis, 2 kilograms of Semen Cuscutae, 2 kilograms of Fructus Lycii, 2 kilograms of Fructus Ligustri Lucidi, 2 kilograms of Polyporus, 2 kilograms of Radix Et Rhizoma Rhei, 2 kilograms of Carapax Trionycis (processed), 2 kilograms of Rhizoma Polygoni Cuspidati, 2 kilograms of Formica fuscas, remove impurity, clean the back mixing and water adding and cross the powder decoction, heat and after 100 ℃, boiled 20-30 minute, make medicinal liquid and leach; Above-mentioned medicinal residues are added water cross the powder decoction, heat and after 100 ℃, boiled 20-30 minute, make medicinal liquid and leach; For the second time recrement adds water and crosses powder and decoct again, heats and boils 20-30 minute after 100 ℃, makes medicinal liquid to leach, and merges three times filtrate, decompression removal moisture, and drying obtains 5 kilograms of the water extracted immersing pastes.

One object of the present invention is to provide the purposes of above-mentioned Pharmaceutical composition in preparation auxiliary treatment all kinds hepatitis medicament.

This Chinese medicine the water extracted immersing paste is called " the described Chinese medicine extract of this paper (or above) " hereinafter.

Above-mentioned composition and mixing acceptable accessories can be made acceptable forms clinically, as tablet, capsule, granule, oral liquid, subcutaneous administration preparation, suppository etc.

Pharmacological research

The main pharmacodynamics of Pharmaceutical composition of the present invention studies confirm that it has strong transaminase lowering effect, i.e. function for protecting liver and reducing enzyme activity.

Edit with reference to Zhang Juntian, " modern pharmacology test method " (volume two), combined publication society of China Concord Medical Science University of Beijing Medical University, the 1397-1398 page or leaf, disclosed method in " first segment chmice acute chemical liver injury model ", set up the acute chemical liver injury model of mouse carbon tetrachloride, carry out the pharmacodynamics test of Pharmaceutical composition anti-liver injury of the present invention.

The test grouping:

1 normal control group: animal does not do any processing, and normal physiological saline is irritated stomach;

2 model control group: after the animal model modeling success, normal physiological saline is irritated stomach;

2 pure Chinese drug-treated group: the water extracted immersing paste 1.04g/kg body weight as indicated above

3 silibinin groups: the 10mg/kg body weight is irritated stomach

4 compositions groups: 10mg/kg body weight silibinin+the water extracted immersing paste 1.04g/kg body weight mentioned above is irritated stomach.

Following table has shown the influence of each group to Mouse Liver function leading indicator GOT, GPT.

Group	Number of animals	GOT (active unit)	GPT (active unit)
				The normal control group	10	21.78±16.75	48.31±19.35
Model control group	10	255.76±76.58	315.25±59.47
				Pure Chinese drug-treated group	10	192.41±68.41	232.89±51.85
The silibinin group	10	107.36±35.37	179.63±21.17
				The compositions group	10	97.21±35.81	117.17±45.79

This table shows that all there is significant difference (P＜0.05) in each group (pure Chinese drug-treated group, silibinin group, compositions group) of treatment with model control group, and all there are significant difference (P＜0.05) in compositions group and pure Chinese drug-treated group, compositions group and silibinin group.Show that there are cooperative effect in silibinin and described Chinese medicinal components in the compositions group.

The pharmaceutics test

Can produce the tablet that contains following component in a conventional manner:

Component The Mg/ sheet

Pharmaceutical composition 200-1000 of the present invention

Corn starch 125.0

Pulvis Talci 75.0

Magnesium stearate 1.0

Wherein compositions is made up of with weight ratio silibinin and Chinese medicine extract mentioned above at 1: 104.

Can produce the capsule that contains following component in a conventional manner:

Component The Mg/ sheet

Pharmaceutical composition 200-1000 of the present invention

Lactose 10.0

Corn starch 20.0

Talcum 5.0

Wherein compositions is made up of with weight ratio silibinin and Chinese medicine extract mentioned above at 1: 104.

Claims (2)

1 one kinds of Pharmaceutical compositions that are used for adjuvant treating hepatitis, it is made up of with weight ratio silibinin and Chinese medicine extract at 1: 104, and described Chinese medicine extract prepares by following method:

4 kilograms of Radix Angelicae Sinensis, 4 kilograms of Poria, 4 kilograms of Indigo Naturaliss, 4 kilograms of Alumens, 4 kilograms of the Radixs Astragali, 4 kilograms of Radix Notoginseng, 2 kilograms of Herba Agrimoniaes, 2 kilograms of Herba Epimedii, 2 kilograms of Herba Phyllanthi Urinariaes, 2 kilograms of Herba Hedyotidis Diffusaes, 2 kilograms of Rhizoma Paridis, 2 kilograms of Radix Bupleuri, 2 kilograms of Radix Salviae Miltiorrhizaes, 2 kilograms of Fructus Schisandrae Chinensis, 2 kilograms of Semen Cuscutae, 2 kilograms of Fructus Lycii, 2 kilograms of Fructus Ligustri Lucidi, 2 kilograms of Polyporus, 2 kilograms of Radix Et Rhizoma Rhei, 2 kilograms of Carapax Trionycis (processed), 2 kilograms of Rhizoma Polygoni Cuspidati, 2 kilograms of Formica fuscas, remove impurity, clean the back mixing and water adding and cross the powder decoction, heat and after 100 ℃, boiled 20-30 minute, make medicinal liquid and leach; Above-mentioned medicinal residues are added water cross the powder decoction, heat and after 100 ℃, boiled 20-30 minute, make medicinal liquid and leach; For the second time recrement adds water and crosses powder and decoct again, heats and boils 20-30 minute after 100 ℃, makes medicinal liquid to leach, and merges three times filtrate, decompression removal moisture, and drying obtains 5 kilograms of the water extracted immersing pastes.

2, the purposes of compositions as claimed in claim 1 in the medicine of preparation adjuvant treating hepatitis.