一测多评法在复方血栓通胶囊8种成分检测中的应用  

Application of quantitative analysis of multi-components by single-marker in detection of eight components of Fufang Xueshuantong capsule

作　　者：于素云[1] 杨立华[1] 王源[1] 付茜[1] 黄建梅[1] 谢称石 陈小新 

机构地区：[1]北京中医药大学中药学院,北京100102 [2]广东众生药业股份有限公司,东莞523325

出　　处：《国际药学研究杂志》2014年第2期231-237,共7页Journal of International Pharmaceutical Research

基　　金：国家"重大新药创制"科技重大专项资助项目(2011ZX11201)

摘　　要：目的建立一测多评法同时测定复方血栓通胶囊中三七皂苷R1、人参皂苷Rg1、Re、Rb1、Rd、哈巴俄苷、隐丹参酮和丹参酮Ⅰ等8种成分的含量,验证该方法在制剂中应用的准确性和可行性。方法以复方血栓通胶囊为研究对象,203 nm测定波长下以三七皂苷R1为内参物,通过测定该成分与人参皂苷Rg1、Re、Rb1和Rd间的相对校正因子,计算成分的含量;270 nm测定波长下以隐丹参酮为内参物,通过测定该成分与哈巴俄苷和丹参酮Ⅰ间的相对校正因子,计算成分的含量,实现一测多评,同时对一测多评的计算值与外标法实测值进行比较,以验证一测多评法的准确性和可靠性。结果 20个批次复方血栓通胶囊中各成分采用校正因子计算的含量值与外标法实测值之间无显著性差异。结论在对照品缺乏的状况下,采用一测多评法可实现复方血栓通胶囊多个成分的含量测定,但复方血栓通胶囊中的8个成分需要选择2个内参物才能准确定量。Objective To set up a new method - quantitative analysis of muhi-components by single-marker（QAMS） to deter- mine eight components - notoginsenoside R1 , ginsenoside Rg1 , Re, Rbj and Rd, harpagoside, cryptotanshinone and tanshinone I in Fufang Xueshuantong（FX） capsule simultaneously, and validate its accuracy and feasibility for application in preparation. Methods FX capsule was used as the research object, notoginsenoside R1 was selected as marker under 203 nm to evaluate the quality of ginsen- oside Rg1, Re and Rb1, Rd, and cryptotanshinone as marker under 270 nm to evaluate the quality of harpagoside and tanshinone I The relative correction factors （RCF） of components were calculated. The method was validated by comparison of the quantitative re- sults between extemal standard method and QAMS method. Results No significant differences were found in the quantitative analysis of components by external standard method and QAMS method. Conclusion It is a convenient and accurate method to determine multi-components when authentic standard substances are not available. It can be used to control the quality of FX capsule.

关 键 词：一测多评法 多波长 相对校正因子 复方血栓通胶囊 

分 类 号：R286.0[医药卫生—中药学]