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Quality control method of complex salvia tablet and application thereof

A quality control method, the technology of Compound Danshen Tablets, applied in the field of quality control of Compound Danshen Tablets, can solve problems such as imperfection and lack of quality control methods, achieve stable quality, avoid product forgery, and ensure normal production

Active Publication Date: 2010-12-15
GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE
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AI Technical Summary

Problems solved by technology

However, the current quality standard of Compound Danshen Tablets only selects one or two active ingredients or index ingredients of Danshen for content determination, and judges the quality based on its content, which is somewhat one-sided, imperfect, and lacks comprehensive and effective quality control methods

Method used

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  • Quality control method of complex salvia tablet and application thereof
  • Quality control method of complex salvia tablet and application thereof
  • Quality control method of complex salvia tablet and application thereof

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Embodiment Construction

[0030] In order for those skilled in the art to better understand the technical solutions provided by the present invention, the following will be described in conjunction with specific embodiments.

[0031] A kind of quality control method of compound salvia miltiorrhiza tablet, comprises the following steps:

[0032] (1) Prepare a mixed reference solution containing tanshinin sodium, rosmarinic acid, shikonic acid, salvianolic acid B, salvianolic acid A, dihydrotanshinone Ⅰ, cryptotanshinone, tanshinone Ⅰ, tanshinone ⅡA, and the contents of each component The concentration is 0.4mg / ml;

[0033] (2) prepare compound Danshen tablet hydroalcoholic solution as need testing solution;

[0034] (3) adopt high-performance liquid chromatography to analyze above-mentioned reference substance solution and need testing solution, chromatographic condition: chromatographic column is that octadecylsilane bonded silica gel is filler; Adopt gradient elution, mobile phase A is 10% acetonitri...

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Abstract

The invention discloses a quality detection method of a complex salvia tablet, comprising the following steps of: (1) preparing a mixed comparison product solution; (2) preparing a complex salvia tablet water-containing alcoholic solution as a test article solution; (3) analyzing the comparison product solution by adopting a high-efficiency liquid chromatography method, wherein the chromatograph condition is as follows: the chromatographic column uses octadeca-alkyl silane bonding silica gel as the filler and adopts gradient elution, the liquid phase A is an acetonitrile aqueous solution and the liquid phase B is acetonitrile; (4), measuring, absorbing the test article solution infused in a liquid chromatograph and measuring by the high-efficiency liquid chromatography method to obtain a high-efficiency liquid chromatography finger print of the complex salvia tablet; and (5) comparing, and monitoring the quality of the complex salvia tablet according to the chromatogram of the comparison product solution and the finger print of the test article solution. The invention also discloses application of the quality detection method applied to identifying the complex salvia tablet. The invention aims at providing a more effective and reliable quality detection method of the complex salvia tablet.

Description

technical field [0001] The invention relates to the field of quality control methods in drug analysis technology, in particular to a quality control method and application of compound Danshen tablets. Background technique [0002] Cardiovascular and cerebrovascular diseases are common diseases that seriously endanger human beings. In recent years, due to social development, changes in work, life, and environment, cardiovascular and cerebrovascular diseases are on the rise. Compound Danshen preparations are mostly used to treat cardiovascular and cerebrovascular diseases, such as Compound Danshen Tablets, Compound Danshen Dropping Pills, Guanxin Danshen Dropping Pills, etc. These compound salvia miltiorrhiza preparations (both containing salvia miltiorrhiza and Panax notoginseng) have different therapeutic effects because of their different formulas, or different formula ratios, or different extraction and refining methods, or different dosage forms. [0003] The compound p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/537A61K9/20G01N30/02G01N30/36A61P9/00A61P9/10
Inventor 黄琳李楚源林青肖晓丽姚小华
Owner GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE
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