摘要
中医药是中国优秀传统文化的代表,经典名方作为中药复方的典型代表,在药品注册方面有了新的突破,但是,也应注意到由此带来的研究挑战,尤其是非临床安全性研究方面的挑战,另外在临床定位、药理基础研究方面,研发者和生产单位还有很长的路要走,应提前为经典名方的长远发展做足准备。
Traditional Chinese medicine is the representative of Chinese excellent traditional culture, and it＇s congratulated that the classical herbal formulae get a new breakthrough in drug registration as the typical representative of traditional Chinese medicine formula. Meanwhile, we should also pay attention to the challenge of research in the new situation, especially for nonclinical safety research. Otherwise, there are so many job to do for research institutions and pharmaceutical companies on the studies of clinical orientation and pharmacology materia basis. It is important to prepare early beause it is a long-term of the development of the classic herbal formulae.
作者
徐旭
王玉丽
涂正伟
李春晓
单淇
侯文彬
XU Xu1,2, WANG Yu-li 1,2 TU Zheng-wei 4,1, LI Chun-xiao1,5, SHAN Qi 1,3, HOU Wen-bin 1,3(1. Center for Research on Traditional Chinese Medicine and Health Products of Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China 2. State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin 300193, China 3. National ＆ Local United Engineering Laboratory of Modem Preparation and Quality Control Technology of TCM, Tianjin 300193, China 4. Tianjin Nankai Hospital, Tianjin 300100, China 5. Tianjin University of Traditional Chinese Medicine, Tianjin 300072, Chin)
出处
《药物评价研究》
CAS
2017年第12期1816-1820,1828,共6页
Drug Evaluation Research
关键词
经典名方
药理学
非临床安全性
临床定位
作用机制
物质基础
classical herbal formulae
pharmacology
nonclinical safety
clinical orientation
effect mechanism
material basis
