增溶辅料的筛选及质量评价一直是制约中药注射剂发展的瓶颈问题之一。为建立适合中药注射剂特点的增溶辅料筛选及质量评价体系,确保中药注射剂临床安全有效,笔者在剖析中药注射剂增溶辅料质量控制现状及特点的基础上,提出并创建以生物检测为主,集"常规检查—物性特征—化学分析—生物检测"序贯分析为一体的符合中药注射剂特点的增溶辅料筛选及质量评价模式和方法,以期为中药注射剂中药用辅料的质量评价提供技术参考。

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一chemical analysis一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.

国家中医药行业专项项目(200708006);国家重大新药创制科技专项(2009ZX09502-003,2009ZX09308-005);国家“十一五”支撑计划重点项目(2008BAI55B04);北京市自然科学基金项目(7112128)