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Quality control method of liuwei wuling tablets

A quality control method, the technology of six flavors and five spirits, applied in measuring devices, material inspection products, instruments, etc., can solve the problem that the chemical information of fingerprints cannot accurately reflect the correlation between ingredients and drug efficacy, the corresponding diseases are different, and it is difficult to comprehensively control Liuwei Wuling tablet quality and other issues

Inactive Publication Date: 2016-07-13
山东世博金都药业有限公司
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AI Technical Summary

Problems solved by technology

In the original quality standard of Liuwei Wuling Tablets, only the content of Schizandrin A was determined, and its single component made it difficult to comprehensively control the quality of Liuwei Wuling Tablets
The chemical fingerprints of traditional Chinese medicine compound can more comprehensively reflect the various chemical components contained in the compound, and can control the quality as a whole. There is a certain bias in the quality control methods established based on the correlation between drug effects.

Method used

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  • Quality control method of liuwei wuling tablets

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Embodiment Construction

[0055] The present invention uses the Latin Chaoli method to randomly sample the 6 medicinal materials in Liuwei Wuling Tablets into 20 groups of different proportions, establishes the corresponding HPLC fingerprints, and measures the anti-hepatic fibrosis activity in vitro, uses SPSS software for analysis, and establishes Liuwei Wuling The spectrum-effect relationship of anti-hepatic fibrosis effect of Ling tablets in vitro, the present invention establishes a relatively complete quality control method on the basis of the effective substances of Liuwei Wuling tablets.

[0056] step one:

[0057] (1) Instrument preparation

[0058] High-performance liquid chromatography; inverted biological microscope; full-wavelength microplate reader; water-jacketed CO2 incubator; electronic analytical balance; precision electronic balance.

[0059] (2) Cell preparation

[0060] LX-2 hepatic stellate cells, provided by Peking Union Medical College Cell Resource Center, were cultured in PRM...

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Abstract

The invention relates to the technical field of compound traditional Chinese preparations, and in particular relates to a quality control method of liuwei wuling tablets. The quality control method is characterized in that 20 different proportion groups are formed by randomly sampling six medicinal materials of the liuwei wuling tablets; a corresponding HPLC fingerprint spectrum is established, and in-vitro anti-hepatic fibrosis activity is measured; and an SPSS software is utilized to analyze, so that a pectrum-effect relationship of in-vitro anti-hepatic fibrosis effect of the liuwei wuling tablets is established. The relatively perfect quality control method is established on the basis of pharmacodynamic substances of the liuwei wuling tablets. Compared with a conventional single-index content measuring method, the quality control method is more comprehensive, scientific and standard, and has the advantages that the content of multiple components is simultaneously measured, so that not only the analysis time is shortened, but also the loss of a solvent is saved.

Description

technical field [0001] The invention relates to the technical field of compound traditional Chinese medicine preparations, in particular to a quality control method for Liuwei Wuling Tablets. Background technique [0002] Liuwei Wuling tablet is a three-class traditional Chinese medicine approved by the State Food and Drug Administration. It is composed of Schisandra chinensis, Ligustrum lucidum, forsythia, curcuma, lettuce, and ganoderma spore powder. It has the effects of nourishing kidney and liver, promoting blood circulation and detoxification. Clinically used for the treatment of chronic hepatitis B. Its clinical curative effect is good, listed as "National Torch Program-Industrialization Demonstration Project". Modern studies have shown that Liuwei Wuling tablets can reduce serum levels of monoamine oxidase (MAO) and transforming growth factor-β1 (TGF-β1), reduce the synthesis of extracellular matrix (ECM), reduce serum hyaluronic acid (HA), laminin ( LN), hydroxypr...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N33/50
CPCG01N30/02G01N33/5008G01N2030/027
Inventor 闫敬武袁海龙程玲杜成德
Owner 山东世博金都药业有限公司
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