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A research method for the stability of salvianolic acid for injection and an analysis method for its degradation pathway

A technology of salvia polyphenolic acid and analysis method, which is applied in the field of stability research of traditional Chinese medicine preparations and achieves the effects of reasonable analysis time, high sensitivity and simple mobile phase

Inactive Publication Date: 2018-06-15
TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Salvianolic acid for injection is an injection directly into the blood. Its main components, phenolic acids and saponins, contain easily destroyed functional group structures, and there is no systematic stability study on them at this stage.

Method used

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  • A research method for the stability of salvianolic acid for injection and an analysis method for its degradation pathway
  • A research method for the stability of salvianolic acid for injection and an analysis method for its degradation pathway
  • A research method for the stability of salvianolic acid for injection and an analysis method for its degradation pathway

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Experimental program
Comparison scheme
Effect test

Embodiment

[0073] 1 Instruments and reagents

[0074] 1.1 Instrument

[0075] UPLC-Q / TOF (Ultra Performance Liquid Chromatography-Time-of-Flight Mass Spectrometry): American Waters Company, Acquity UPLC H-Class; UPLC: American Waters Company, Acquity UPLC H-Class; Ultrapure Water Instrument: American Millipore Company, Mill-QⅡ ;Precision pipette gun: Germany eppendorf company, Eppendorf; Centrifuge: China Xiangyi Centrifuge Instrument Co., Ltd., H1650-W; Water bath: China Boxun Industrial Co., Ltd., SSW-600-7S; pH meter: Switzerland Mettler-Toledo Company, DELTA 320; constant temperature and humidity chamber: Germany MMM company, Climacell 111,222,404,707; 1 / 100,000 balance: Switzerland Mettler Toledo company, AX205.

[0076] 1.2 Reagents

[0077] Methanol: Sigma Company; acetonitrile: Sigma Company; potassium chloride, calcium chloride, aluminum chloride: Tianjin Damao Company; ultrapure water: Millipore ultrapure water purification system.

[0078] 2 sample preparation

[0079] 2.1...

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Abstract

The invention discloses a researching method for stability of salvianolic acid used for injection. The researching method comprises the following steps: separately subjecting salvianolic acid used for injection to high-temperature degradation test, oxydative degradation test, metal ion degradation test and illumination degradation test so as to obtain degradation products; detecting the degradation products of the degradation test by using ultra-high performance liquid chromatography-mass spectrometry so as to obtain mass spectra and analyzing fragment ions in the mass spectra so as to determine degradation products; enriching the degradation products and simultaneously detecting a salvianolic acid raw material and the degradation products by using ultra-high performance liquid chromatography so as to obtainultra-high performance liquid chromatograms; and carrying out indicating analysis on a random to-be-detected sample and determining degradation products of the sample according to the mass spectra and the chromatograms. The invention also discloses an analytical method for the degradation pathway of salvianolic acid. The methods provided by the invention can simultaneously determine active components in and degradation products of salvianolic acid used for injection, and have the characteristics of high sensitivity, small external interference, a fast testing speed, etc.

Description

technical field [0001] The invention relates to stability research of traditional Chinese medicine preparations, in particular to a research method for the stability of salvianolic acid for injection and an analysis method for its degradation pathway. Background technique [0002] Traditional Chinese medicine injection is under the guidance of the theory of traditional Chinese medicine, using modern science and technology and methods, extracting and purifying traditional Chinese medicine decoction pieces to make solutions, emulsions for injection into the body, and powders or concentrated solutions prepared into solutions before use. preparation. Compared with traditional Chinese medicine formulations such as pills, powders, ointments, and pills, Chinese medicine injections have the advantages of rapid efficacy, strong action, and high bioavailability, especially in the treatment of cardiovascular and cerebrovascular diseases, acute infectious diseases, and malignant tumors....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 王萌任晓亮董鹏志张慧杰丁丽琴姜苗苗刘虹高秀梅樊官伟孙立丽
Owner TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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