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作 者:林志燕[1] 杨萍[1] 黄晓会[1] LIN Zhiyan;YANG Ping;HUANG Xiaohui(Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,China 200092)
机构地区:[1]上海交通大学医学院附属新华医院,上海200092
出 处:《中国药业》2021年第22期43-46,共4页China Pharmaceuticals
基 金:国家自然科学基金青年科学基金项目[81603099]。
摘 要:目的建立测定人全血中西罗莫司浓度的超高效液相色谱串联质谱(UHPLC-MS/MS)法,并用其监测医院肝移植术后患者的西罗莫司血药浓度。方法色谱柱为Agilent SB C18柱(50 mm×2.1 mm,1.8μm),流动相为水-乙腈(含0.1%甲酸),梯度洗脱,流速为0.3 m L/min,柱温为40℃,进样量为5μL;以依维莫司为内标,电喷雾离子源,多反应离子监测模式,正离子模式检测。选取2019年7月至2020年6月在医院监测西罗莫司血药浓度的126例次肝移植术后患者为研究对象。结果126例次肝移植患者的稳态血药谷浓度中,53例次在3~8 ng/m L范围内,68例次低于该范围,5例次高于该范围,患者用药后的血常规、肝肾功能、血脂指标与用药前相比总体无显著性差异。结论西罗莫司在人体内的生物利用度存在个体差异,监测血药浓度有助于及时调整其用药剂量,确保临床用药安全、有效。Objective To establish an ultra-high-performance liquid chromatography-tandem mass spectrometry(UHPLC-MS/MS)method for the determination of sirolimus in the human whole blood,and to monitor the blood concentration of sirolimus in patients after liver transplantation in our hospital.Methods The chromatographic column was Agilent SB C18 column(50 mm×2.1 mm,1.8μm),the mobile phase was water-acetonitrile(containing 0.1%formic acid)with gradient elution,the flow rate was 0.3 m L/min,the column temperature was 40℃,and the injection volume was 5μL.Everolimus was used as the internal standard(IS),and the determination was performed by multiple reactions monitoring(MRM)mode via electrospray ionization(ESI)source.A total of 126 patients after liver transplantation who monitored the blood concentration of sirolimus in our hospital from July 2019 to June 2020 were selected as the research objects.Results Among 126 patients after liver transplantation,the steady-state blood drug valley concentrations of 53 cases were in the range of 3-8 ng/m L,those of 68 cases were lower than this range,and those of five cases were higher than this range.The blood routine,liver and kidney function,and blood lipid indexes of patients after medication were not significantly different from those before medication.Conclusion There are individual differences in the bioavailability of sirolimus in the human body.Monitoring the blood drug concentration is helpful to adjust the medication dose in time to ensure the safety and effectiveness of the clinical medication.
关 键 词:西罗莫司 超高效液相色谱串联质谱法 肝移植 血药浓度监测
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