中国临床药理学杂志2017，Vol.33Issue(15)：1469-1471,3.DOI:10.13699/j.cnki.1001-6821.2017.15.026
高效液相色谱串联质谱法和化学发光微粒子免疫分析法测定人全血中他克莫司浓度的一致性评价
Quality consistency evaluation for determination of blood tacrolimus concentration by two methods: high performance liquid chromatography-tandem mass spectrometry method and chemiluminescence microparticle immuno assay
摘要
Abstract
Objective To analyze the correlation between high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method and chemiluminescence microparticle immuno assay (CMIA) for determination of tacrolimus concentration in human blood,and the application of two methods in the determination of tacrolimus concentration.Methods Tacrolimus concentrations of 119 blood samples were determined by HPLC-MS/MS method and CMIA,respectively.The quality consistency between the concentrations by different methods was evaluated by Spearman method.Results The concentrations of tacrolimus in blood raged from 1.30 ng · mL-1 to 28.50ng · mL-1.The mean value of concentrations was (7.57 ± 5.16)ng · mL-1 by HPLC-MS/MS method and (7.66 ±5.22) ng · mL-1 by CMIA,and the ration value calculated as (concentrations determined by HPLC-MS/MS method/concentrations determined by CMIA × 100％) was (100.37 ± 16.28)％.The conversion formula was yHPLC-MS/MS =0.97xCMIA + 0.16 (r =0.988 9).The P value evaluated by student's t test showed that there was no statistical difference among the concentrations determined by two different methods.Conclusion There is a good quality consistency between HPLC-MS/MS method and CMIA for the determination of tacrolimus concentration in blood.There was no statistical difference among the concentrations determined by two different methods,both the two methods can be applied to therapeutic drug monitoring for tacrolimus in blood.关键词
他克莫司/高效液相色谱串联质谱法/化学发光微粒子免疫分析法/治疗药物监测Key words
tacrolimus/high performance liquid chromatography-tandem mass spectrometry/chemiluminescence microparticle immuno assay/therapeutic drug monitoring分类
医药卫生引用本文复制引用
赵瑞,李鹏飞,杜萍,祝锦,刘洪川,于伟越,刘丽宏..高效液相色谱串联质谱法和化学发光微粒子免疫分析法测定人全血中他克莫司浓度的一致性评价[J].中国临床药理学杂志,2017,33(15):1469-1471,3.基金项目
北京市金桥工程种子基金资助项目(2014-46-C) （2014-46-C）
