中药安全性认识和中药新药研发的风险管理策略

Traditional ideas of Chinese medicine and risk management strategies for new traditional Chinese medicine safety

一直以来中药安全性是监管的热点和难点问题。为了提升对中药安全性的全面认识,本文从立足于临床应用的角度,对毒药和毒性的起源、沿革以及安全性认识等方面进行梳理和总结,分析中药安全性风险管理存在的关键技术问题,如基础研究薄弱、安全性风险防控措施研究不足、安全性研究成果对临床应用的指导性有限等,并提出探索建立中药安全性风险管理流程、充分挖掘利用有毒中药的疗效特点及加强对已知中药安全性风险的警示等有针对性的风险管理建议,以期为促进中药安全性风险管理提供借鉴。

The safety of traditional Chinese medicine(TCM)has been a hot and difficult issue in supervision.In order to advance our understanding of the safety of TCM,the origin,evolution and safety awareness of poisons and toxicity were reviewed and summarized from the perspective of clinical application.The key technical problems with the safety risk management of TCM were the weak basic research,insufficient research on the prevention and control measures of safety risks of TCM,and the influence of research findings on clinical application.Finally,some suggestions on risk management were offered for the development of TCM,including the exploration of TCM safety risk management processes,making full use of toxic properties of Chinese medicine and early warning of known TCM risks.