摘要
目的评定用电感耦合等离子体质谱法(ICP-MS)测定人血白蛋白中铝含量的不确定度。方法使用ICP-MS测定人血白蛋白中铝含量,采用“自上而下”测量不确定度评定方法,评定不确定度来源并计算合成不确定度。结果人血白蛋白中铝含量在3个质控水平的扩展不确定度分别为0.54 ng/mL、1.68 ng/mL、4.54 ng/mL,满足《中华人民共和国药典》2020版中生物分析方法指导原则相关要求。结论“自上而下”法评定人血白蛋白中铝残留量不确定度简便、快捷,适合生物实验室分析方法不确定度评定。
Objective To evaluate the determination uncertainty of aluminum residues in human albumin by inductively coupled plasma mass spectrometry(ICP-MS).Methods The aluminum residues in human albumin was determined by ICPMS,and the top-down method was applied to assess the reasons of uncertainty and calculate the uncertainty.Results The relative standard uncertainty of the aluminum content in human albumin at the three quality control levels was 0.54 ng/mL,1.68 ng/mL and 4.54 ng/mL,respectively,which met the requirements of the guidelines for bioanalytical methods in the Chinese Pharmacopoeia(2020).Conclusion The top-down method is simple and quick to assess the uncertainty of aluminum residues in human albumin,and is suitable for the uncertainty assessment of analytical methods in biological laboratories.
作者
郑美玲
李智明
李丹凤
ZHENG Meiling;LI Zhiming;LI Danfeng(Guangxi Institute for Food and Drug Control,Nanning 530021,China)
出处
《中国输血杂志》
CAS
2023年第5期420-423,共4页
Chinese Journal of Blood Transfusion
基金
广西壮族自治区药品监督管理局药品安全科研项目(桂药监科自2022-041)。
