含有毒性中药新药研制中需关注的问题  

Problems in preparation of toxic herbs in the process of research and development of new Traditional Chinese Medicine

作　　者：王停[1] 韩玲[1] 金芳[1] 程龙[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：《中国新药杂志》2007年第19期1545-1546,共2页Chinese Journal of New Drugs

摘　　要：为引起研发者对中药新药中所含毒性中药的重视,本文从毒性中药的依法炮制、用法用量、质量控制以及该制剂的长期毒性试验要求、临床方案、临床研究手册、说明书的撰写等方面分别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 toxicity trial, clinical trial, the manual of clinical research and script of 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：毒性中药 中药新药 研制 

分 类 号：R28[医药卫生—中药学] R95[医药卫生—中医学]