中国药物警戒 ›› 2025, Vol. 22 ›› Issue (5): 564-569.
DOI: 10.19803/j.1672-8629.20240994

• 法规与管理研究 • 上一篇    下一篇

基于人用经验的中药复方制剂新药药学研究

李灿, 刘乐环, 陈霞, 曲建博*   

  1. 国家药品监督管理局药品审评中心,北京 100076
  • 收稿日期:2024-12-15 出版日期:2025-05-15 发布日期:2025-05-19
  • 通讯作者: *曲建博,男,博士,主任药师,中药新药药学评价。E-mail:qvjb@cde.org.cn
  • 作者简介:李灿,女,硕士,高级工程师,中药新药药学评价。
  • 基金资助:
    2023年药品监管科学全国重点实验室第一批课题; 中国药品监管科学行动计划第二批重点项目(国药监科外[2021]37号); 国家重点研发计划(2023YFC3504001)

Pharmacy of Chinese Medicine Compound Preparations Based on Human Experiences

LI Can, LIU Lehuan, CHEN Xia, QU Jianbo*   

  1. Center for Drug Evaluation, NMPA, Beijing 100076, China
  • Received:2024-12-15 Online:2025-05-15 Published:2025-05-19

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

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