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 Injection by Tube Plate Method

作　　者：于佳 肖宇 王斯文 张肖宁 YU Jia;XIAO Yu;WANG Si-wen;ZHANG Xiao-ning(Heilongjiang Institute for Drug Control,Institute for Biological Safety Inspection,Harbin 150080,China)

机构地区：[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

出　　处：《海峡药学》2024年第1期52-56,共5页Strait Pharmaceutical Journal

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。OBJECTIVE To evaluate the uncertainty of the test results of rifamycin sodium for injection.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 uncertainty.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 analysis 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 

分 类 号：R927[医药卫生—药学]