Quality control of Chinese materia medica injection based on Q-marker-- Taking salvianolic acids for injection as an example
10.7501/j.issn.0253-2670.2019.19.019
- VernacularTitle: 基于Q-marker的中药注射剂质量控制研究思路--以注射用丹参多酚酸为例
- Author:
Xiao-Qin SU
1
Author Information
1. Tianjin Tasly Pride Pharmaceutical Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Chinese materia medica injection;
Lithospermic acid;
Q-marker;
Quality control;
Rosmarinic acid;
Salvianolic acid B;
Salvianolic acid D;
Salvianolic acid Y;
Salvianolic acids for injection
- From:
Chinese Traditional and Herbal Drugs
2019;50(19):4663-4672
- CountryChina
- Language:Chinese
-
Abstract:
Based on the concept of quality marker (Q-marker) and the application of Q-marker in traditional Chinese medicine, the quality control methods of Chinese materia medica injections were put forward, taking salvianolic acids for injection as an example. Through the analysis of components, efficacy and pharmacokinetics, it has been identified that the Q-marker of salvianolic acids for injection were salvianolic acid B, rosmarinic acid, lithospermic acid, salvianolic acid D, and salvianolic acid Y. The quality control system of multi-index content determination, fingerprint, near infrared on-line control, and biological quality control was established with Q-marker as the core. It provides a reference for the new ideas of quality control of Chinese materia medica injection.
