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Quality control method of pharmaceutical preparation for treating liver and kidney disease

A quality control method and technology of traditional Chinese medicine preparations, applied in the direction of testing pharmaceutical preparations, pharmaceutical formulas, urinary system diseases, etc., can solve the problem of not finding the same or similar patents or documents, etc., to achieve the effect of increasing stability and ensuring drug safety

Inactive Publication Date: 2006-12-13
王衡新
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In addition, no identical or similar patents or documents were found through patent and document searches

Method used

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Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment 1

[0016] Identify and take 0.9g of the preparation of the present invention, grind it finely, add 5ml of ethyl acetate to dissolve, filter, take the filtrate as the solution of the test sample, and take another silibinin reference substance, add ethyl acetate to make each 1ml containing 1ml As the reference substance solution, according to the thin-layer chromatography test, absorb 10ul of each of the above two solutions, respectively point on the same silica gel G thin-layer plate, use chloroform-ethanol (9:1) as the developer, develop, take out , dried, and sprayed with 10% ferric chloride ethanol solution, in the chromatogram of the test product, on the position corresponding to the chromatogram of the reference product, spots of the same color are displayed.

specific Embodiment 2

[0017] Determination of content was determined according to high performance liquid chromatography, chromatographic conditions and system suitability test, using octadecylsilane bonded silica gel as filler, methanol-water-glacial acetic acid (50:50:0.5) as mobile phase, detection wavelength 288nm, the number of theoretical plates calculated based on silibinin peak should not be less than 2000;

[0018] For the preparation of the reference substance solution, take 0.5 mg of the silibinin reference substance, accurately weigh it, put it in a 100ml measuring bottle, add methanol to dissolve it and dilute it to the mark, shake it up to get final product;

[0019] For the preparation of the test solution, take the drug, grind it finely, take 0.1g, accurately weigh it, put it in a 50ml measuring bottle, add an appropriate amount of methanol, ultrasonically treat it for 30 minutes, let it cool, add methanol to dilute to the mark, shake well, filter pass, get;

[0020] Determination ...

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Abstract

The invention provides a quality controlling method of medicinal preparation for treating liver and kidney diseases, wherein the preparation is prepared from the following raw materials (by weight percent): silybum mariamum 13.6-40.9%, Wurenchun extract 59.1-86.4%. The preparation can be made into the dosage forms of capsules, drop pills or dispersant tablets.

Description

technical field [0001] The invention discloses a quality control method of traditional Chinese medicine preparations, in particular to a quality control method of traditional Chinese medicine preparations for treating liver and kidney diseases. Background technique [0002] The preparation of the present invention is made from the raw material silymarin and Wurenol extract according to a certain weight percentage, has the effects of nourishing the liver and nourishing the kidney, detoxifying and removing dampness, and can be used for liver and kidney yin deficiency, hypochondriac pain and anorexia caused by unclear dampness and poison. Abdominal distension, backache, fatigue, yellow urine, chronic hepatitis and elevated transaminases. [0003] Drugs are the key to treating patients and are related to people's lives. Therefore, the quality of drugs should be strictly controlled. Therefore, the present inventor has developed the quality control method of the present invention...

Claims

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Application Information

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IPC IPC(8): A61K36/57A61K9/48A61K9/20A61K9/14A61P1/16A61P13/12G01N30/02G01N33/90G01N33/15
Inventor 王衡新
Owner 王衡新
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