Medicine combination for treating viral hepatitis and quality control method thereof

A quality control method and viral hepatitis technology, applied in the field of pharmaceutical composition for treating viral hepatitis, pharmaceutical composition for treating viral hepatitis and its preparation, capable of solving problems such as addiction, obvious side effects, and drug resistance

Active Publication Date: 2009-02-04
BEIJING ASIA EAST BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the drugs currently used clinically for the treatment of viral hepatitis have certain curative effects, they

Method used

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  • Medicine combination for treating viral hepatitis and quality control method thereof
  • Medicine combination for treating viral hepatitis and quality control method thereof
  • Medicine combination for treating viral hepatitis and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0037] Experimental Example 1: Pharmacodynamic test of the drug group on liver protection, enzyme reduction, choleretic, jaundice reduction, phagocytosis and clearance

[0038] Drug group I: get the pharmaceutical composition mixture prepared in Example 2 of the present invention

[0039] Pharmaceutical group II: take the pharmaceutical composition mixture prepared in Example 13 of the present invention

[0040] Control group: commercially available Qingre Shugan mixture.

[0041] 1. Hepatoprotective and enzyme-lowering effects

[0042] 1. Protective effect on acute liver injury

[0043] Take 84 Kunming mice, weighing 18-20 g, half male and half male, and randomly divide them into 7 groups. The first group: the normal control group, fed with the same amount of drinking water every day; the second group: the model group, fed with the same amount of drinking water every day; the third group: the drug group I, fed with the drug group I liquid 30ml ( Equivalent to crude drug 9...

experiment example 2

[0068] Experimental Example 2 Excipient screening experiment

[0069]Optimization of Inclusion Process Conditions of Volatile Oil β-Cyclodextrin

[0070] Because the volatile oil is easy to lose, if the volatile oil is directly added, it will be lost for a long time or slightly heated, thereby reducing the content and affecting the curative effect of the medicine. In order to solve this problem, the method of β-cyclodextrin inclusion was adopted, and the conditions of inclusion were optimized by orthogonal experiment.

[0071] See the accompanying drawings for the experimental procedure.

[0072] Inclusion by saturated aqueous solution method: Weigh a certain amount of β-cyclodextrin, add appropriate amount of distilled water, and heat it in a 70°C water bath to prepare a 5% aqueous solution of β-cyclodextrin. At different temperatures (20°C, 40°C, 60°C) stirring at a speed of 2500 rpm, adding a certain amount of volatile oil, stirring fully for a certain period of time, to ...

experiment example 3

[0083] Experimental example 3 Identification test of capillary

[0084] Preparation of Blank Samples According to the ratio of herb taste and dosage of the medicine group of the present invention, a group of medicines not containing capillary root, white peony root, angelica sinensis, salvia miltiorrhiza and Polygonum cuspidatum were prepared respectively, and blank preparations were made according to the preparation process.

[0085] Preparation of blank solution Take the daily dose of blank sample 14 / 1000 of the pharmaceutical composition preparation capillary, add 20ml of water to dissolve, extract 2 times with ethyl acetate, 30ml for the first time, 20ml for the second time, and combine the ethyl acetate solution , evaporated to dryness in a water bath, and the residue was dissolved by adding 1ml of ethyl acetate as a blank solution.

[0086] Preparation of the sample solution Take the same amount of samples of the drug group and substance, and prepare the sample solution ...

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Abstract

The invention discloses a pharmaceutical composition used for treating virus hepatitis, a preparation method and a quality control method thereof. The pharmaceutical composition has the raw materials of herba artemisiae capillaris, radix isatidis, rhizoma dryopteris crassirhizomae, indian bread, radix curcumae, herba scutellariae barbatae and patchouli, etc. The quality control method is that the traditional Chinese medicine provided by the invention is obtained by a great deal of creative experiments and screening as well as by the screening for a sample treatment method and the selection to a developing agent in a distinguishing method, and the distinguishing specificity is good; furthermore, the methods are economical and applicable, has rapid result and can be applied to different thin-layer plates. In a content measuring method, by the screening for a processing method of samples and test product and the selection to the developing agent, the content measuring method can effectively carry out quality control on products; furthermore, compared with other methods, the product measured by the method has more stable drug effect.

Description

[0001] field of invention [0002] The invention relates to a pharmaceutical composition, a preparation method and a quality control method, in particular to a pharmaceutical composition for treating viral hepatitis, a preparation method and a quality control method. Background technique [0003] Viral hepatitis is a common infectious disease caused by a variety of hepatitis viruses. It has the characteristics of strong infectivity, complex transmission routes, wide epidemic range, and high incidence rate. Clinically, the main manifestations are fatigue, loss of appetite, nausea, vomiting, hepatomegaly and liver function damage. Some patients may have jaundice and fever. Some patients develop urticaria, arthralgia or upper respiratory symptoms, and severe cases may even develop liver cirrhosis or even liver cancer, seriously endangering human health. Although the drugs currently used clinically for the treatment of viral hepatitis have certain curative effects, they have def...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61P1/16A61P31/14A61P31/20G01N30/02G01N30/90A61K35/10
Inventor 付立家付建家
Owner BEIJING ASIA EAST BIO PHARMA CO LTD
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