风湿、骨科、外科含毒性药材中药新药研制中需关注的问题  

Problems in preparation of toxic herbs in process of research and development of new traditional Chinese medicine of rheumatism,orthopedics and surgery

作　　者：王停[1] 周刚[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国中药杂志》2012年第17期2653-2655,共3页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(30973937)

摘　　要：为引起研发者对风湿、骨科、外科中药新药中所含毒性药材的重视,该文从毒性药材的炮制、用法用量、工艺、质量控制以及制剂的长期毒性试验要求、临床疗程、临床试验安全性指标的选择和检测等方面全面阐述了研发者需关注的问题。This article emphasized the problems about toxic herbs in the process of research and development of new traditional Chinese medicine （TCM）.It describe and explain what the researchers should pay attention to,such as processing, the usage and dosage, quality control of the toxic herbs, and chronic in toxicity trial,course of treatment,choice and detection of safe target in clinical trial about preparation of the new TCM. The goal is to lead the researchers to attach the importance of toxic herbs in the new TCM.

关 键 词：毒性药材 中药新药 研制 

分 类 号：R288[医药卫生—中药学]