基于源头控制的中药制剂质量研究

中药制剂的研究设计、中药材质量、饮片炮制加工以及中药制剂生产过程控制是影响中药制剂质量的关键因素,也是中药制剂质量控制的源头。通过对中药制剂质量控制现状的分析,对《中药新药用药材质量控制研究技术指导原则(试行)》《中药新药用饮片炮制研究技术指导原则(试行)》《中药新药质量标准研究技术指导原则(试行)》3个指导原则主要内容的介绍和解读,提出基于源头控制的中药制剂质量研究思路,即重视中药制剂的研究设计,重视作为中药制剂原料的中药材质量,重视饮片炮制加工及重视制剂生产过程控制,构建符合中药特点的质量标准体系,控制中药制剂的质量。

Research on quality of traditional Chinese medicine preparations based on control of source

The research and design of traditional Chinese medicine (TCM) preparations, quality of Chinese medicinal materials, processing of decoction pieces and production process control of TCM preparations are the key factors affecting the quality of TCM preparations and the source of quality control of TCM preparations. Through the analysis of the current situation of the quality control of TCM preparations, the main content of three guidelines for pharmaceutical research of TCM including Guideline on Quality Control Study of Medicinal Materials Used for New TCM (Trial), Guideline on Processing Study of Herbal Pieces Used for New TCM (Trial), and Guideline on Quality Standards Study of New TCM (Trial) were introduced and interpreted in this paper. The research idea of TCM preparations quality based on control of source was put forward. The quality research should attach importance to the design of TCM, quality of TCM materials, quality control of processing of decoction pieces and production technology of TCM preparations, so as to establish the quality standard system conforming to the characteristics of TCM and effectively control quality of TCM preparations.