中药创新药物研究开发的回顾、策略与实践  

Retrospection,stratagem,and practice on innovative drug research and development of Chinese materia medica

作　　者：杨义芳[1] 杨必成[1] 金丽丽[1] 

机构地区：[1]上海医药工业研究院中药研究室,上海200240

出　　处：《中草药》2009年第10期1513-1519,共7页Chinese Traditional and Herbal Drugs

摘　　要：以"十一五"、"十五"重大科技专项为主线,回顾中药创新药物研究的历程,通过剖析美国FDA第一个植物药VeregenTM对中药研发的启示,以及对创新药物研究中的重大成果学习、感悟,试图提出创新中药研发策略并指出实践的路径。以中药复方创制新药为中药创新的主要途径,创新可以从新物质,包括新化合物和新有效部位/群或组分配伍,一个已知化合物或已知提取物等的新药用及名优中成药的二次开发3方面实现;并借鉴国际经验以近代临床应用为基础的靶点依赖性先导物的筛选、评价与优化和在分子及基因水平对中药复方的作用机制和分子靶点进行诠释,来支撑具有中国特色的原创治疗药的研究与开发。Taking the national key scientific and technological project in 11^th Five-year and 10th Fiveyear Plan as its main clue, the innovative Chinese materia medica （CMM） research course has been reviewed in this paper. Based on the enlightenment from the first herbal medicine Veregen^TM, which has been approved by FDA, together with the study and comprehension of many great achievements of new drug research, the strategy of innovative CMM research and development （R＆D） and its practical route is going to be put forward in this article. With the innovative Compound Prescription of CMM research as the main innovative approach, innovation can be realized by the following three aspects： New substances, including new compound, new effective fraction/group or new components and their combinations; new indication of known compounds or extracts; the secondary development of high-quality Chinese patent medicine. Besides, in order to support the R ＆ D of original drugs with Chinese characteristics, the international experiences in target-dependent screening and evaluation and optimization of leading compounds based on clinical application should be referenced, and the mechanism and targets of traditional Chinese medicine by genetic and molecular level be clarified.

关 键 词：中药创新药物 研究开发 策略 

分 类 号：R28[医药卫生—中药学]