海峡药学2024，Vol.36Issue(1) ：52-56.

管碟法测定注射用利福霉素钠含量不确定度评定

Evaluation of Uncertainty in Determination of Rifamycin Sodium for Injec-tion by Tube Plate Method

于佳 肖宇 王斯文 张肖宁
海峡药学2024，Vol.36Issue(1) ：52-56.
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  • 维普
  • 万方数据

管碟法测定注射用利福霉素钠含量不确定度评定

Evaluation of Uncertainty in Determination of Rifamycin Sodium for Injec-tion by Tube Plate Method

于佳 1肖宇 1王斯文 1张肖宁1
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作者信息

  • 1. 黑龙江省药品检验研究院/生物安全检验所,黑龙江哈尔滨 150080
  • 折叠

摘要

目的 评定注射用利福霉素钠含量检测结果的不确定度.方法 根据JJF1059.1-2017《测量不确定的评定与表达》,通过考察影响不确定度因素,剖析不确定度来源,细化不确定度分量,进一步得出扩展不确定度.结果 本实验的测定结果可表示为Q=99.2％±5.4％(P=95％,k=2),测量不确度的主要来源为重复性及实验设计带来的误差和溶液的配制稀释过程.结论 该方法可适用于管碟法测定注射用利福霉素钠含量的不确定度分析.

Abstract

OBJECTIVE To evaluate the uncertainty of the test results of rifamycin sodium for injec-tion.METHODS According to JJF1059.1-2017,the expanded uncertainty was further obtained by investigating the factors affecting the uncertainty,analyzing the sources of uncertainty,refining the components of uncertain-ty.RESULTS The measurement result of this experiment caould be expressed as Q=99.2％±5.4％(P=95％,k=2).The main sources of measurement uncertainty were repeatability,errors caused by experimental design and the preparation and dilution process of the solution.CONCLUSION This method can be applied to the uncertainty a-nalysis of the determination of rifamycin sodium for injection by the tube disk method.

关键词

管碟法/注射用利福霉素钠/不确定度

Key words

Tube and disc method/Rifamycin sodium for injection/Uncertainty

引用本文复制引用

出版年

2024
海峡药学
中国药学会福建分会

海峡药学

影响因子：0.643
ISSN：1006-3765
参考文献量7
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