基于整合药理学的中药注射剂质量风险管控策略及关键技术

Strategies and key technologies for risk control and management in quality of Chinese medicine injections based on integrated pharmacology

该文聚焦于中药注射剂质量风险问题,通过分析其重大技术需求,提出中药整合药理学研究策略,进而构建了中药注射剂质量风险管控关键技术体系。然后以生脉注射液为例,研究建立了基于整合药理学的中药注射剂质量风险管控方法。

This paper focuses on the quality risk control and management of Chinese medicine （CM） injections. The most important technological requirements are analyzed, and a strategy for integrated pharmacology to study CM mechanism is proposed. A key technology system for quality risk control and management was further constructed. The strategy and technology system was finally applied to Shengmai injection for quality risk control and management.