中药大品种质量标准提升研究的思路与实践

Research ideas and application on the quality standard improvement of major traditional Chinese medicine varieties

关键词:  中药大品种  质量标准  思路  实践

Key words:  major traditional Chinese medicine varieties  quality standard  research idea  application

摘要:

中药大品种质量标准提升研究是中药大品种二次开发研究的重要内容，通过质量标准提升研究，建立可溯源的、与临床疗效高度关联的全程质量控制体系和质量标准，并为中药质量控制提供可参照的模式和研究范例。本文以疏风解毒胶囊和元胡止痛滴丸为例，论述中药大品种质量标准提升研究的思路、方法与研究实践。从质量控制指标的发现和确定、样品测定和质量标准的确定角度论述了中药大品种质量标准提升研究的路径和方法。最后，结合研究实践，建立了中药质量标准研究新的集成模式。

Abstract:

The quality standard improvement of major traditional Chinese medicine variety was the key research of secondary development of major traditional Chinese medicine (TCM) varieties. By quality standard improvement study, the whole process of quality control system and quality standards with characteristic of easy to trace and high association with clinical effect were established which may provide a model of reference and research paradigm for the quality control of TCM. The research ideas and methods of the quality standard improvement of major traditional Chinese medicine varieties were discussed from the aspects of finding and determining the quality control indicators, sample determination and quality standard determination with examples of Shufeng Jiedu capsules and Yuanhu Zhitong dropping pills. A new integrated mode of TCM quality standard study was established combining with the research practice.