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
赵晓霞 1阳长明 1韩炜 1曲建博 1顾宇凡 1关宏峰 1赵巍 1孙昱1
作者信息
- 1. 国家药品监督管理局 药品审评中心药品监管科学全国重点实验室,北京 100076
- 折叠
摘要
《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.
Abstract
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.
关键词
中药复方制剂/古代经典名方目录/基准样品/质量研究/中药监管科学Key words
traditional Chinese medicine compound preparations/catalogued ancient classical prescriptions/reference sample/quality research/TCM regulatory science引用本文复制引用
基金项目
国家药监局中国药品监管科学行动计划(国药监科外[2019]23号)
药品监管科学全国重点实验室课题(第一批)(2023)()
出版年
2024
NETL
NSTL
万方数据