Study on Stability of Salvianolate Lyophilized Injection and Establishment of Stability-Indicating Analysis Method
10.13422/j.cnki.syfjx.20192214
- VernacularTitle:注射用丹参多酚酸稳定性研究及其稳定性指示性分析方法的建立
- Author:
Xue-xiao CAO
1
;
Lei WANG
1
;
Xiao-liang REN
1
;
Meng WANG
2
;
Yan-ru DENG
1
Author Information
1. School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine (TCM), Tianjin 301617, China
2. The Institute of TCM, Tianjin University of TCM, Tianjin 301617, China
- Publication Type:Research Article
- Keywords:
salvianolate lyophilized injection;
degradation mechanism;
stability-indicating method
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2020;26(2):129-134
- CountryChina
- Language:Chinese
-
Abstract:
Objective::To study the degradation of salvianolate lyophilized injection (SLI) and establish a stability-indicating analysis method. Method::UPLC-Q-TOF-MS/MS was used to conduct a qualitative study on the main components of SLI, and a stability-indicating analysis method was established for simultaneous determination of the original components of SLI and its degradation products. The stability of SLI were systematically assessed under physicochemical conditions of high temperature, oxidation, metal ions. Result::Totally 13 main active ingredients in SLI were identified, and a semi-quantitative analysis was performed. Under the conditions of high temperature, oxidation, light, trivalent ion and divalent ion, 6, 4, 3, 4 and 1 new degradation products were added respectively. The established stability-indicating analysis method can simultaneously determine the degradation products of the main components and their active components in SLI, with a good separation effect. Conclusion::According to the degradation mechanism of the main ingredients in SLI, macromolecular polyphenol acid compounds are degraded into small molecular compounds, such as tanshinol and protocatechu aldehyde by a series of reactions, like benzofuran open-loop, hydrolysis of ester bond and removal of DSS. The stability-indicating analysis method can be used for the stability quality control of traditional Chinese medicine Salvianolate Lyophilized Injection (SLI).
