Pharmacy of Chinese Medicine Compound Preparations Based on Human Experiences

doi:10.19803/j.1672-8629.20240994

Abstract

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

CLC Number:

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/EN/Y2025/V22/I5/564

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