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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。
This paper reviews the history of research on innovative medicines in traditional Chinese medicine by focusing on major scientific and technological projects such as Eleventh Five-Year Plan and 15th Five-Year Plan. By analyzing the revelation of VeregenTM, the first US FDA on Chinese medicine research and development, In the major achievements of learning, sentiment, trying to put forward innovation strategy of Chinese medicine research and pointed out the path of practice. To create new drugs with traditional Chinese medicine as the main method of innovation of traditional Chinese medicine, innovation can be new substances, including new compounds and new effective parts / groups or components compatibility, a known compound or known extract of new drugs and famous Chinese medicine Sub-development of three aspects; and draw on international experience in modern clinical application-based target-dependent precursor selection, evaluation and optimization and molecular and gene level on the mechanism of traditional Chinese medicine and molecular targets for the interpretation of the mechanism to support Research and development of original therapeutic drugs with Chinese characteristics.