中药标准物质替代测定法是符合中药特点的多指标质量控制的一种有效模式。为了指导该法的建立,统一并规范该法的研究及在国家药品标准中的应用,并证明采用的方法是否适合于相应的检测要求,探讨并提出本技术指导原则。本指导原则从该法的定义与分类、定量的原理与方法、色谱峰的定位与确认、技术要求四个方面进行论述。当中药指纹图谱(特征图谱)鉴别项或多指标含量测定项采用中药标准物质替代测定法时,按照本原则进行方法学验证研究。
Abstract
Substitute reference substance method is an effective approach for quality control of multiple components in accordance with the characteristics of traditional Chinese medicines. The purpose of the guideline is to guide the establishment of substitute reference substance method, prove the conformance of the method to the requirements for testing, and standardize the study method and its application in national drug standards. The topics of the guideline include the definition and classification of substitute reference substance method, the principles and approaches of quantitative analysis, the identification and confirmation of chromatographic peaks, and technical requirements. When substitute reference substance method is used for fingerprint identification or multiple components assay in traditional Chinese medicines, the analytical method can be validated following the guideline.
关键词
替代对照品法 /
一测多评法 /
双标多测法 /
双标线性校正法 /
对照提取物 /
标准物质(对照品)
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Key words
substitute reference substance method (SRS) /
quantitative analysis of multi-components by single marker (QAMS) /
two reference substances for determination of multiple components (TRSDMC) /
linear calibration using two reference substances (LCTRS) /
extract reference substance /
reference substance
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中图分类号：
R917
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参考文献
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脚注
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基金
国家十二五“重大新药创制”专项(2014ZX09304307-002);国家自然科学基金资助项目(81303214,81173506); 中国食品药品检定研究院中青年发展研究基金(2011A1)
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