药学学报, 2020, 55(12): 2854-2861
引用本文:
肖亭, 王晨, 姚尚辰, 冯艳春, 胡昌勤. HPLC校正因子法在药物分析中的应用[J]. 药学学报, 2020, 55(12): 2854-2861.
XIAO Ting, WANG Chen, YAO Shang-chen, FENG Yan-chun, HU Chang-qin. Application of an HPLC correction factor method in pharmaceutical analysis[J]. Acta Pharmaceutica Sinica, 2020, 55(12): 2854-2861.

HPLC校正因子法在药物分析中的应用
肖亭, 王晨, 姚尚辰, 冯艳春, 胡昌勤
中国食品药品检定研究院, 北京 102629
摘要:
随着对药物有关物质的深入研究和国内仿制药一致性评价的开展,杂质相对于主成分的校正因子测定越来越受到重视。本文在分析国内外近年来校正因子相关文献的基础上,介绍了校正因子的定义、目前的测定方法和应用情况;阐述了目前杂质校正因子在测定和应用中的一些规律和要点,并对其在测定和应用中存在的问题进行了讨论,为今后校正因子测定的标准化和规范化研究提供参考依据。
关键词:    HPLC      校正因子      响应因子      主成分自身对照法      对照品替代法     
Application of an HPLC correction factor method in pharmaceutical analysis
XIAO Ting, WANG Chen, YAO Shang-chen, FENG Yan-chun, HU Chang-qin
National Institutes for Food and Drug Control, Beijing 102629, China
Abstract:
With the in-depth study of related substances and the development of consistency evaluation of generic drugs, relative correction factors are gaining increasing attention. By analyzing the domestic and foreign literature on correction factors in recent years, this paper describes the correction factor component, the current measurement method and its application. The rules and key points of use of an impurity correction factor and its determination and application are described, and some problems in its determination and application are discussed, providing a reference and basis for the standardization of research on impurity correction factors in the future.
Key words:    HPLC    correction factor    response factor    main component self-contrast method    substitute reference substance method   
收稿日期: 2020-05-07
DOI: 10.16438/j.0513-4870.2020-0697
基金项目: 国家“重大新药创制”科技重大专项资助项目(2017ZX09101001).
通讯作者: 冯艳春,Tel:86-10-53851539,E-mail:fyc@nifdc.org.cn;胡昌勤,Tel:86-10-53851532,E-mail:hucq@nifdc.org.cn
Email: fyc@nifdc.org.cn;hucq@nifdc.org.cn
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