文章摘要
吴德芹,孙鲁宁,钱 依,方云茜,张宏文,童明庆,陈安九,王永庆.LC⁃MS/MS法测定人尿液中法罗培南的浓度及其尿药排泄研究[J].南京医科大学学报,2018,(5):648~652
LC⁃MS/MS法测定人尿液中法罗培南的浓度及其尿药排泄研究
Determination of faropenem in human urine by a LC⁃MS/MS method and study on urinary excretion
投稿时间:2017-03-02  
DOI:10.7655/NYDXBNS20180515
中文关键词: 法罗培南  LC⁃MS/MS  尿药排泄
英文关键词: faropenem  LC⁃MS/MS  urinary excretion
基金项目:国家自然科学基金(81503160,81673515);江苏省“六大人才高峰”项目(2014?YY?001)
作者单位
吴德芹 南京医科大学第一附属医院药学部江苏 南京 210029 
孙鲁宁 南京医科大学第一附属医院药学部江苏 南京 210029 
钱 依 南京医科大学第一附属医院药学部江苏 南京 210029 
方云茜 南京医科大学第一附属医院药学部江苏 南京 210029 
张宏文 南京医科大学第一附属医院药学部江苏 南京 210029 
童明庆 南京医科大学第一附属医院检验学部江苏 南京 210029 
陈安九 南京医科大学第一附属医院药学部江苏 南京 210029 
王永庆 南京医科大学第一附属医院药学部江苏 南京 210029 
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中文摘要:
      目的:建立测定人尿液中法罗培南浓度的LC?MS/MS测定法,研究法罗培南在中国健康受试者尿液中的排泄特征。方法:以氢氯噻嗪作为内标,色谱柱为Waters Cortecs C18(2.1 mm × 50 mm,2.7 μm),流动相为乙腈?0.5%甲酸(10∶90),质谱采用电喷雾离子源和负离子多反应离子监测方式。健康受试者分为300 mg和400 mg两个剂量组,分别单次和多次静脉输注法罗培南,测定给药后法罗培南的浓度,计算尿药排泄参数。结果:法罗培南在0.506~506.000 μg/mL范围内线性良好,准确度、批内和批间精密度均小于15%,基质效应不影响测定结果,法罗培南在测定过程中稳定性符合要求。健康受试者单次静脉输注注射用法罗培南钠(以法罗培南计300 mg)后,尿液中法罗培南的累积排泄量为(65.16 ± 43.63)mg,平均累积排泄率为(21.7 ± 14.5)%。结论:该方法可用于人尿液中法罗培南浓度的测定。
英文摘要:
      Objective:To establish a LC?MS/MS method for the determination of faropenem in human urine,and to investigate its urinary excretion after intravenous administration of faropenem in healthy volunteers. Methods:The hydrochlorothiazide was using as the internal standard. Chromatographic separation was carried on a Waters Cortecs C18(2.1 mm × 50 mm,2.7 μm). The mobile phase was consisted of acetonitrile and 0.5% formic acid(10∶90). Electrospray ionization source was applied and operated in the negativeion mode using multiple reaction monitoring. Urinary excretion parameters were calculated after single and multiple intravenous administration of faropenem at 300 mg and 400 mg to healthy volunteers. Results:The calibration curve was linear in the range of 0.506?506.000 μg/mL. The accuracy,inter? and intra? precision were all below 15%. The matrix effect did not affect the determination results. Analytes were stable during the study. The average cumulative excretion and average cumulative excretion rates of faropenem in healthy volunteers after single intravenous infusion of 300 mg were(65.16 ± 43.63)mg and(21.7 ± 14.5)%,respectively. Conclusion:This method is suitable for the determination of faropenem in human urine.
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