建立完善符合中药特点的中药药学研究技术指导原则体系

To Establish and Improve Guideline System for Pharmaceutical Research of Traditional Chinese Medicine with Characteristics of Traditional Chinese Medicine

通过对国家药品监督管理局最新发布的《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个中药药学技术指导原则的解读,对建立完善符合中药特点的中药药学研究技术指导原则体系的背景和思路进行介绍,强调应尊重中医药理论和传统用药经验,以质量源于设计、全过程质量控制和整体质量评价、分阶段研究和全生命周期管理的理念开展中药新药研究工作,以供业内同仁参考。

This paper introduces the background and ideas for establishing and improving the guideline system for pharmaceutical research of traditional Chinese medicine(TCM)with the characteristics of TCM through the interpretations of three guidelines for pharmaceutical research of TCM,including guideline on quality control study of medicinal materials used for new TCM,guideline on processing study of herbal pieces used for new TCM and guideline on quality standards study of new TCM.It is emphasized to respect TCM theory and traditional medicine experience,to carry out the research of new TCM with the concept of quality by design,whole process quality control and whole quality evaluation,stage research and lifecycle management in order to provide reference for the industry.