New screening mode and practice for solubilizing excipient meeting with characteristics of Chinese materia medica injection
- Author:
Dan YAN
1
Author Information
1. Institute of Chinese Meteria Medica
- Publication Type:Journal Article
- Keywords:
Biological detection;
Chinese materia medica (CMM) injection;
Quality evaluation;
Screening mode;
Solubilizing excipient
- From:
Chinese Traditional and Herbal Drugs
2011;42(5):833-836
- CountryChina
- Language:Chinese
-
Abstract:
The screening with quality control of solubilizing excipient is one of the reasons that restrict the development of Chinese materia medica (CMM) injection. In order to establish an screening and quality evaluation system for solubilizing excipient so as to ensure the safety and utility of CMM injection in clinic, the author introduced a new method which meets with the characteristics of CMM injection, for evaluating the quality of solubilizing excipient. This original method consists of the sequential analysis of "routine examination-physical property-chemical analysis-biological detection", laying particular emphasis on the biological detection. This research is expecting to provide ideas and technical reference for the safety evaluation of CMM injection.
