[关键词]
[摘要]
本文从源自临床的几个中药基本问题入手,通过对中药标准的概念与范畴以及当今中药标准化研究的现状与问题的探讨分析,首次提出面向临床的中药标准化研究的重要设想。结合临床的中药标准化研究的核心目标和关键就是要建立面向临床的中药标准体系,包括药性标准、品质标准、用量标准以及中药调剂操作规程(GUP),“使质量标准更加贴近临床,使临床标准更有科学依据”,为中医临床“用好药,用好药”与中药科技产业上中下游协调发展提供技术支持和参考依据。
[Key word]
[Abstract]
The standardization for Chinese medicines (CM) is a great topic on modernization and globalization as well as sustainable development of TCM. However, medical and pharmaceutical researchers usually focus on the upper and middle stages in their own fields, and pay less attention to the Clinics-oriented research for the TCM standardization, including dosage, usage, efficacy and medicinal property of CM, let alone the Clinics-oriented research. This paper highlights the Clinics-oriented research for the TCM standardization and proposes to establish a Clinics-oriented CM standards system consisting of the medicinal property standard, quality standard, dosage standard and good usage practice (GUP). This system may directly serve the rational and scientific application of TCM in clinics. The Clinics-oriented research for the CM standardization is considered a key aspect and strategic direction of TCM modernization.
[中图分类号]
[基金项目]
国家重大新药创制专项关键技术课题(2009ZX09502-022):符合中药特点的质量评价方法和体系研究,负责人:肖小河;国家杰出青年基金项目(30625042):中药鉴定学,负责人:肖小河;国家科技部公益性行业专项课题(200807020):我国20种重要道地药材的形成模式、商品规格及其行业标准的研究,负责人:肖小河。