中药制剂稳定性研究中含量测定的问题分析  

Analysis on Problem of Content Determination of Stability of Traditional Chinese Medicine Preparations

作　　者：梁锦杰 吴燕红[1] 张燕梅[2] 罗裕[1] 刘静[1] 朱盛山[1] 黄娟萍[1] 蔡延渠[1] 

机构地区：[1]广东药学院中药开发研究所,广州510006 [2]广东药学院,广州510006

出　　处：《中国实验方剂学杂志》2014年第12期253-258,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"十二五"重大新药创制科技重大专项(2011ZX09102-011-01)

摘　　要：本文旨在揭示中药制剂稳定性研究中含量测定存在的问题,为控制制剂质量、保证药物疗效、科学进行稳定性研究提供参考。通过检索2000年以来国内有关中药制剂稳定性含量测定研究的文献报道,对其内容进行分类总结。并从稳定性研究法规、含量测定指标成分以及测定方法发展趋势三方面综述了中药制剂稳定性研究的概况,从指标成分的选择、样品前处理、仪器分析方法等方面对制剂稳定性研究中含量测定的存在问题进行深入分析,可为中药制剂稳定性研究提供参考。目前制剂标准的制定偏重于制剂工艺,为了指标成分达标,通过各种工艺使其富集,造成了考核指标与临床疗效脱节的现象,使稳定性考察意义大大降低。所以,开展中药制剂的药效物质研究,减少用药的不安全性,完善中药制剂稳定性含量测定研究,需要在不断实践的基础上,吸收先进的方法与技术手段,进行多方面的理论探讨和实验研究,以控制中药制剂的质量。This paper aims to reveal the existing problems of the content determination of the stability study of traditional Chinese medicine （TCM） preparations and provide the reference for the quality control of the preparations, drug efficacy and the scientific stability study. Through searching the literature reports about the content determination of the stability study of TCM preparations since 2000, summarized the overview of stability of TCM preparations from the three aspects in the regulations of stability study, index component and the development trend of content determination method. And deeply analysis the existing problems of content determination of stability study, from the following three aspects： the index components selection, sample pretreatment and analytical methods, which can provide a reference for the stability study of TCM. At the same time, the editor noticed that R ＆ D personnel focus on preparation process in the formulation standard preparation. In order to make the index components meet the standard, they make its enrichment by a variety of process and ignore the relationship between the index components and clinical effect, which greatly reduce the meaning of stability test. Therefore, in order to study on the effects material in TCM preparation, reduce the unsafe drug and improve study of content determination of stability study of TCM preparations, we need to absorb the advanced methods and techniques and carry out various aspects of theoretical study and experimental research on the basis of practice.

关 键 词：中药制剂 稳定性研究 含量测定 指标成分 样品处理 分析方法 

分 类 号：R284.1[医药卫生—中药学]