Zhao Xiao-Xia, Yang Chang-Ming, Han Wei, Qu Jian-Bo, Gu Yu-Fan, Guan Hong-Feng, Zhao Wei, Sun Yu
State Key Laboratory of Drug Regulatory Science,Center for Drug Evaluation,National Medical Products Administration Beijing 100076,China.
Zhongguo Zhong Yao Za Zhi. 2024 Jun;49(12):3404-3408. doi: 10.19540/j.cnki.cjcmm.20240315.601.
The concept of reference sample was put forward in the Guidance on CMC of Traditional Chinese Medicine Compound Preparations Developed from Catalogued Ancient Classical Prescriptions(Interim). The research on reference sample is a key link in the research and development of traditional Chinese medicine(TCM) compound prescriptions from catalogued ancient classical prescriptions(known as Category 3.1 TCM). This paper discusses the content of research on reference sample by analyzing the characteristics of Category 3.1 TCM and the purpose of research on reference sample. Furthermore, suggestions on the research of reference sample are proposed according to the development and evaluation practice of Category 3.1 TCM and research achievements of TCM regulatory science, aiming to provide reference for colleagues in this industry.
参考样品的概念在《古代经典名方中药复方制剂说明书撰写指导原则（试行）》中被提出。参考样品研究是古代经典名方中药复方制剂（以下简称中药3.1类）研发的关键环节。本文通过分析中药3.1类的特点及参考样品研究的目的，探讨参考样品研究的内容。此外，根据中药3.1类的研发及评价实践和中药监管科学研究成果，对参考样品研究提出建议，旨在为业内同行提供参考。
