基于人用经验的中药复方制剂新药药学研究

doi:10.19803/j.1672-8629.20240994

摘要/Abstract

摘要： 目的探讨中药复方制剂新药药学研究相关要求,为中医临床处方转化为中药新药提供参考。方法通过文献研究、法规梳理,结合相关指导原则及中药复方制剂新药审评经验,探讨中药复方制剂新药药学研究常见逻辑及关注点。结果基于人用经验研发中药复方制剂新药,应尊重中医药传统及特色、用好中医药理论、人用经验和临床试验相结合（简称“三结合”）研发模式、质量源于设计等基本思路。结论在中药复方制剂新药研发的过程中,人用经验所蕴含的药用物质能有效地传递到临床试验用药品和上市品种,是其药学研究的关键。

关键词: 人用经验, 中药复方制剂, 新药, 药学研究, 三结合

Abstract: Objective To find out about the requirements related to the chemical manufacture and control(CMC)study of newly-registered compound preparations of TCM in order to provide data for the conversion of clinical prescriptions of TCM into new traditional Chinese medicines(TCMs). Methods Based on related literature, regulations and guidelines and on evaluations of newly-registered compound preparations of TCMs, cerns related to the CMC study of newly-registered compound preparations of TCMs were explored. Results Empirical research and development of newly-registered compound preparations of TCMs should take into consideration the conventions and characteristics of TCMs and incorporate the theories of TCMs, human experience and clinical trials. Conclusion In the course of research and development of newly-registered compound preparations of TCMs, medicinal substances contained in human experience can be effectively translated into drugs for clinical trials and marketed products, which is the key to the CMC study.

Key words: Human Experience, Chinese Medicine Compound Preparation, New Drugs, Pharmaceutical Research, Three-Combinations

中图分类号:

李灿, 刘乐环, 陈霞, 曲建博. 基于人用经验的中药复方制剂新药药学研究[J]. 中国药物警戒, 2025, 22(5): 564-569.

LI Can, LIU Lehuan, CHEN Xia, QU Jianbo. Pharmacy of Chinese Medicine Compound Preparations Based on Human Experiences[J]. Chinese Journal of Pharmacovigilance, 2025, 22(5): 564-569.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I5/564

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