试论按古代经典名方目录管理的中药复方制剂的基准样品研究

Discussion on reference sample research of traditional Chinese medicine compound preparations developed from catalogued ancient classical prescriptions

《按古代经典名方目录管理的中药复方制剂药学研究技术指导原则(试行)》提出了“基准样品”概念,基准样品研究是按古代经典名方目录管理的中药复方制剂研究的关键环节。该文通过分析古代经典名方中药复方制剂(中药3.1类)特点、基准样品研究目的,探讨、阐释了基准样品研究的主要内容,并结合该类制剂研发和审评实际,总结中药监管科学研究成果,对该类制剂研发提出建议,以供业内同仁参考。

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.