中药注射液“Q-Markers”的辨析研究——丹红注射液研究实例

摘要

Quality control of traditional Chinese medicine is of great importance to ensure its safety and effectiveness in clinic,and is also an obstacle impeding the modernization of traditional Chinese medicine.Though,the complexity of traditional Chinese medicine resulted in some relative weakness of quality standard researches.The critical point need addressing is to establish a sound quality standard system conforming to the characteristics of traditional Chinese medicine in the process of the modernization of Chinese medicine.In this paper,in regard to Dan Hong injection,discriminant strategy of "Q-Markers" from traditional Chinese medicine injection was clarified from three aspects:what ingredients,which to control and how to control,providing a new vision in the field of the quality standard researches of traditional Chinese medicine.%中药质量控制是保证中药临床用药安全性和有效性的重要措施,也是制约中药现代化进程的重要因素.由于中药的复杂性,目前的中药质量标准研究仍比较薄弱.构建符合中药特点的质量控制体系,是当前中药现代化进程中亟待解决的难题.本文以丹红注射液为例,从化学物质基础、质量标志物、质控方法3个层次,阐述中药注射液“Q-Markers”辨析策略,为中药质量控制研究提供新思路.