对照提取物在中药整体质量控制中的应用

基于中医理论指导下的全面药效物质基础研究是中药质量标准体系构建的基石,对照提取物法为其提供了一种新的分析思路。本文综述了定性和定量对照提取物在中国药典2010年版、美国药典36版、欧洲药典8.0和日本药局方16版中的应用,提出了对照提取物的制备流程,分析了该方法在研究中存在的问题,并以大黄定性对照提取物和重楼总皂苷定量对照提取物为例,阐述了对照提取物在中药整体质量控制中的应用,为对照提取物法的后续研究及实现中药整体质量控制提供了有益的参考。

Studies on the holistic quality control of traditional Chinese medicine(TCM) ware the foundation of the TCM quality standard system.Extractive reference substance(ERS) is put forward as a new approach,which makes studies easier,more convenient and more realistic.Here,we summarize the application of both qualitative ERS and quantitative ERS in ChP 2010,USP 36-NF 31,EP 8.0 and JP 16 together with advantages and disadvantages of ERS.From practical pespective,the preparation method and application of ERS,such as the ERS of Rhei Radix et Rhizoma and the ERS of Paridis Rhizoma ware proposed.The study can provide a reference for further study of this method and holistic quality control of TCM.