中药安全性事件的危险因素与防治对策

Risk factors and prevention and control countermeasures of traditional Chinese medicine safety incidents

回顾马兜铃酸、雷公藤、八角莲、槟榔、仙灵骨葆胶囊、鱼腥草注射剂、双黄连注射剂等引发的中药安全性事件,旨在探讨影响中药安全性的危险因素,对中药毒性成分、生产工艺、储藏条件、体质差异、给药剂量、风险管控等方面存在的安全性问题进行探讨,提出加强源头控制以确保质量合格、探明配伍机制以增效减毒、提高生产标准以推进质量统一、完善法规政策以加强管控、健全安全性评价体系以确保质量达标等建议,以期为促进临床合理用药、减少中药安全性事件提供帮助。

This paper reviews the safety incidents of traditional Chinese medicine,caused by such as aristolochic acids,Tripterygium wilfordii,Dysosma versipellis,Areca catechu,Xianling Gubao Capsule,Yuxingcao Injection and Shuanghuanglian Injection,to explore the risk factors affecting the safety of traditional Chinese medicine.This paper reviews the safety problems existing in the toxic components,production process,storage conditions,physical differences,dosage,risk management and control of traditional Chinese medicine,and puts forward suggestions such as strengthening source control to ensure that the quality is qualified,improving production standards to promote quality unification,improving laws and policies to strengthen control,and improving the safety evaluation system to ensure that the quality is up to standard,so as to provide help for promoting the rational use of clinical drugs and reducing the safety incidents of traditional Chinese medicine.