静注人免疫球蛋白(pH 4)中IgA残留量的不确定度分析  

Uncertainty Analysis of IgAResidue in Human Immunoglobulin(pH 4)for Intravenous Injection

作　　者：陈承贵 庞赛 江坤 王平 CHEN Cheng-gui;PANG Sai;JIANG Kun;WANG Ping(Shenzhen Institute for Drug Control,Guangdong Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,广东深圳518057

出　　处：《中国药物评价》2024年第4期280-285,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:紫外-可见分光光度法测定静注人免疫球蛋白中IgA残留量,并对其进行不确定度评定。方法:采用紫外-可见分光光度法,测定波长340 nm,比色皿狭缝1 nm,依据操作过程及测定环节引入的影响因素,对各个分量进行评估。结果:静注人免疫球蛋白(pH 4)中的IgA残留量结果为103μg·mL^(-1),扩展不确定度为10μg·mL^(-1)(k=2)。结论:本实验首次对静注人免疫球蛋白(pH 4)中的IgA残留量不确定度分量进行分析和评定,为血液制品检验提供了影响因素来源分析,为提高检验结果准确性提供了数据分析。Objective:To determine the residual amount of IgA in human immunoglobulin(pH 4)for intravenous injection by UV-VIS spectrophotometry and evaluate its uncertainty.Methods:Ultraviolet-visible spectrophotometry was used to measure the wavelength with 1nm slit colorimetric dish.Each component was evaluated according to the operation process and the influencing factors introduced in the determination process.Results:The IgA residue in human immunoglobulin(pH 4)for intravenous injection was 103μg·mL^(-1),with an expanded uncertainty of 10μg·mL^(-1)(k=2).Conclusion:This research firstly evaluated and analyzed the uncertainty component of IgA residue in human immunoglobulin(pH 4)for intravenous injection,which provided a source analysis of influencing factors for blood products inspection and data analysis to improve the accuracy of test results.

关 键 词：静注人免疫球蛋白 IgA残留量 不确定度 紫外可见分光光度法 

分 类 号：R927.12[医药卫生—药学]