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测量结果不确定度评定在我国药物分析领域中的应用

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  • 中国食品药品检定研究院,北京 102629
第一作者 Tel: (010)53851539; E-mail:1304298769@qq.com
*王晨 Tel:(010)53851540; E-mail:wangchen@nifdc.org.cn
冯艳春 Tel: (010)53851539; E-mail:fyc@nifdc.org.cn

收稿日期: 2021-03-16

  网络出版日期: 2024-06-24

Application of measurement uncertainty evaluation in the field of pharmaceutical analysis in China

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  • National Institutes for Food and Drug Control, Beijing 102629, China

Received date: 2021-03-16

  Online published: 2024-06-24

摘要

测量不确定度作为目前国际社会普遍接受和推荐使用的定量评价测量结果质量的参数,在药物分析领域中发挥着越来越重要的作用。本文在分析国内近5年来药物分析领域测量结果不确定度评定相关文献的基础上,介绍了测量不确定度的定义、有关指导原则、在我国药物分析领域的发展历史、评定方法和步骤及其在各分析方法中的应用现状,归纳总结了各文献中药物分析方法主要的不确定度来源和提高测量结果准确性和可靠性的建议,并对其在评定过程中存在的问题和发展前景进行了讨论和展望,以期帮助更多的药物分析工作者更好地理解和应用不确定度评定,推动其在药物分析领域的不断发展。

本文引用格式

肖亭, 王晨, 姚尚辰, 冯艳春, 许明哲 . 测量结果不确定度评定在我国药物分析领域中的应用[J]. 药物分析杂志, 2021 , 41(11) : 1851 -1859 . DOI: 10.16155/j.0254-1793.2021.11.01

Abstract

As a widely accepted and recommended tool to quantitatively characterize the quality of measurement results, measurement uncertainty evaluation is playing an increasingly important role in the field of pharmaceutical analysis. Based on the review of relevant literature of measurement uncertainty evaluation in pharmaceutical analysis inside of China in the past five years, this paper introduces the definition of measurement uncertainty, relevant guidelines, development history in pharmaceutical analysis, evaluation approaches and its application in various analytical methods, and then summarizes the main sources of uncertainty of drug analysis in literatures reviewed and suggestions for improving the reliability of testing results, and finally discusses the existing problems, flaws and future prospects for uncertainty evaluation, with the aim to promote more pharmaceutical scientists to better understand and extensively and appropriately apply uncertainty evaluation in the field of pharmaceutical analysis and quality control.

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