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
投稿时间:2020-11-06     点此下载全文
引用本文:杨平,阳长明.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[J].中国现代中药,2020,22(12):1951-1956
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作者中文名作者英文名单位中文名单位英文名E-Mail
杨平 YANG Ping 国家药品监督管理局 药品审评中心,北京100022 Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China  
阳长明 YANG Chang-ming 国家药品监督管理局 药品审评中心,北京100022 Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China 阳长明,主任药师、高级审评员,研究方向:药品技术审评;Tel:(010)85242875,E-mail:yangchm@cde.org.cn 
中文摘要: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。
中文关键词:中药新药  指导原则体系  质量控制  中药特点
 
To Establish and Improve Guideline System for Pharmaceutical Research of Traditional Chinese Medicine with Characteristics of Traditional Chinese Medicine
Abstract: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.
keywords:new traditional Chinese medicine (TCM)  guideline system  quality control  characteristics of TCM
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