LC-MS/MS法测定人血浆中多黏菌素B的不确定度评定  

Uncertainty evaluation for the determination of polymyxin B in human plasma by LC-MS/MS

作　　者：黄晓岚 刘笑芬 王雨 俞振伟 范亚新 毋海兰 郭蓓宁 张菁 HUANG Xiao-lan;LIU Xiao-fen;WANG Yu;YU Zhen-wei;FAN Ya-xin;WU Hai-lan;GUO Bei-ning;ZHANG Jing(Institute of Antibiotics,Key Laboratory of Clinical Pharmacology of Antibiotics,Ministry of Health,National Clinical Research Center for Aging and Medicine,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院抗生素研究所,国家卫健委抗生素临床药理重点实验室,上海200040

出　　处：《中国临床药理学杂志》2021年第11期1421-1424,共4页The Chinese Journal of Clinical Pharmacology

基　　金：科技部“重大新药创制”科技重大专项资助项目(2017ZX09304005);上海市科委课题产学研医基金资助项目(17DZ1910402);上海市科学技术委员会基金资助项目(19411964900)。

摘　　要：目的评定液相色谱-质谱联用(LC-MS/MS)法测定人血浆中多黏菌素B的不确定度。方法本研究对多黏菌素B的主要成分多黏菌素B1、多黏菌素B2浓度测定过程中的影响因素,包括样品重复测量、标准曲线回归、对照品纯度、对照品称量、标准曲线制备等进行分析评定,根据各分量计算合成不确定度和扩展不确定度。结果人血浆多黏菌素B1低、中、高浓度(0.15,0.50和4.00μg·mL^(-1))的扩展不确定度分别为3.30×10^(-3),6.17×10^(-2)和4.51×10^(-1)μg·mL^(-1),多黏菌素B2低、中、高浓度(1.65×10^(-2),5.49×10^(-2)和4.39×10^(-1)μg·mL^(-1))的扩展不确定度分别为1.98×10^(-2),2.11×10^(-2)和6.16×10^(-2)μg·mL^(-1)。结论 LC-MS/MS法测定人体血浆中多黏菌素B浓度的不确定度在低浓度时主要由样品重复测量和标曲制备引入,在中、高浓度时主要由样品重复测量、标准曲线回归及标曲制备引入。Objective To evaluate the uncertainty of polymyxin B in human plasma by LC-MS/MS. Methods This study analyzed the influence factors in the whole process of the determination of polymyxin B1 and B2,the two major components of polymyxin B, including sample repeat measurement, standard curve regression, reference substances purity, weighing and standard solution preparation. The combined uncertainty and expanded uncertainty were analyzed with all the components. Results The expanded uncertainties for polymyxin B1 at concentrations of 0.15,0.50 and 4.00 μg·mL^(-1) were 3.30×10^(-3), 6.17×10^(-2) and 4.51×10^(-1) μg·mL^(-1), respectively. The expanded uncertainties for polymyxin B2 at concentrations of 1.65×10^(-2), 5.49×10^(-2) and 4.39×10^(-1) μg·mL^(-1) were 1.98×10^(-2), 2.11×10^(-2) and 6.16×10^(-2) μg·mL^(-1),respectively. Conclusion The uncertainty of the polymyxin B determination in human plasma by LC-MS/MS was mainly caused by sample repeat measurement and standard curve regression at low concentration, by sample repeat measurement, standard curve regression and standard solution preparation at medium and high concentration.

关 键 词：多黏菌素B 不确定度 LC-MS/MS 血浆样本 

分 类 号：R978.1[医药卫生—药品]