新形势下中药创新药物的发现与研发

Discovery,research and development forinnovative drug of traditional Chinese medicine under new situations

该文根据近年来生命科学的快速发展和我国对中药创新药物审批要求的不断提升,在分析基于中医药理论和天然产物资源的创新药物发现的优势以及当前中药新药研发存在的问题的基础上,从基于中药资源的活性化合物发现、中药有效部位及其复方制剂的发现、基于经典名方的中药创新药物的研发、基于名优中成药的创新药物研发以及临床有效方剂的新药转化等5个方面,系统介绍了新形势下中药创新药物的发现和研发思路,并就加快我国中药创新药物的发展提出五点建议,为中药创新药物的研发提供参考。

Referring to the rapiddeveloped life science and the higher requirements for the approval of innovative Chinese drugsin recent years,this paperdescribedsystematicallythe discovery,research and development（ RD） approaches for the innovative Chinese drugs under the new situation from the following five aspects,i. e.,active components discovered from TCMs,the discovery of effective fractions of TCMs and their formulae,the RD of TCM innovative drugs based on famous classic prescriptions and famous Chinese patent drugs,and the transformation of clinical effective prescriptions,on the basis of analysing the advantages of innovative drugs derived from natural products based on TCM theories and the problems existed in current RD of new TCM drugs. Moreover,five suggestions are also given for the rapid development of TCM innovative drugs in China. All these will provide reference for the RD of TCM innovative drugs.