人血浆中维生素E烟酸酯的LC-MS/MS法测定及其药动学  

Determination of Vitamin E nicotinate in human plasma by LC-MS/MS method and its pharmacokinetics

作　　者：张佳丽[1] 于晓佳[1] 吴华[1] 潘世芬[1] 郑文婕[2] 

机构地区：[1]首都医科大学附属北京朝阳医院药事部,北京100020 [2]北京理工大学生命科学院,北京100081

出　　处：《上海医药》2009年第4期164-166,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立LC-MS/MS法测定人血浆中维生素E烟酸酯浓度的方法。方法:研究22例健康受试者自身对照、双周期交叉口服0.2g维生素E烟酸酯受试制剂和参比制剂后的药代动力学。采用C18柱,流动相为甲醇(含0.05%甲酸),内标为盐酸氨溴索,以选择性离子反应检测(MRM)扫描方式进行检测,检测离子质荷比(m/z)为536.5→165.1(维生素E烟酸酯)和378.9→263.9(盐酸氨溴索)。血浆样品用NaOH碱化、沉淀蛋白,石油醚提取浓缩。结果:血浆中维生素E烟酸酯线形范围为1.44～1666.7ng/mL,维生素E烟酸酯最低定量浓度为1.44ng/mL。结论:本方法检测速度快、灵敏度高、专属性强,可用于维生素E烟酸酯口服制剂的人体药动学研究。Objective：To establish a method for determination of the level of Vitamin E nicotinate in human plasma. Methods： Twenty - two healthy subjects were recruited and 0.2 g test capsule or reference capsule of Vitamin E nicotinate was randomly administered by them under a self- control and two- way cross -over design. The pharmacokinetic parameters were investigated. A C18 column was used. Methanol was used as the mobile phase ano ambroxol hydrochloride as an internal control. Selected multiple reaction monitoring （MRM） was performed to detect the plasma level of Vitamin E nocotinate. The m/z was 536.5 - 165.1 for Vitamin E nicotinate and 378.9 to 263.9 for ambroxol hydrochloride. The plasma samples were alkalized by NaOH, precipitated, and extracted by petroleum ether. Results： The linear range of plasma Vitamin E nicotinate was 1.44 -1 666.7 ng/mL （r =0. 999 4）. The lowest limit of quantification was 1.44 ng/mL. Conclusion： The method is characterized by rapidity, sensitivity and specificity. It can be used in the pharmacokinetic research of Vitamin E nicotinate in human beings.

关 键 词：维生素E烟酸酯 高效液相色谱-质谱联用 药动学 

分 类 号：R969.1[医药卫生—药理学]