中药新药研发的立题依据及评价思路

Establishment and evaluation of new drug R&D of traditional Chinese medicine

立题依据是中药新药研发的一项重要内容,本文分析了当前注册申请的中药新药不同的立题依据,介绍了源于古方、依据临床应用经验、依据中医药理论组方、依据现代药理研究结果等不同的立题依据在新药研发中的风险和优势,分析了申报资料应注意哪些问题,如何开展相关的研究工作,如何才能提高新药研发的成功率。并从审评角度分析了非临床药效学试验的必要性,药效学试验应重点关注的内容,以及其结果对支持中药新药进行临床试验在立题依据方面的作用。

Establishment application of new drugs is an important content in traditional Chinese medicine（TCM） research and development（R＆D）.This paper analyzed the current application for the registration of new drug of TCM.We introduced the risk and advantage of different bases in new drug research.These bases include ancient prescriptions,clinical application experience,theories of TCM formula and the results of modern pharmacology study.The questions to which attention should be paid in applications for new drugs were analyzed.How to develop the related research work and how to improve the success rate of drug research were discussed.The necessity,key content of pharmacodynamic experiment and the test results to support the Chinese herbal medicine for clinical trials were analyzed in the view of evaluation.