摘要
建立了 LC-MS/MS法测定人血浆中的替曲朵辛(1).采用Waters Atlantis HILIC Silica色谱柱(2.1 mm×100mm,3 μm),流动相由乙腈、水和乙酸组成,流速为0.40 mL/min,柱温为40 ℃,进样量为10 μL.该方法的线性范围为0.02～5 ng/mL,LLOQ为0.02 ng/mL.首次进行注射用1的人体药代动力学研究,经验证,符合人体药动学研究要求.5、10、20 μg3 个剂量组单次给药的主要药动学参数分别为cmax(0.129 2±0.041 9)、(0.253 7±0.036 9)、(0.530 8±0.162 6)ng/mL;tmax(0.321±0.144)、(0.510±0.313)、(0.541±0.275)h;t1/2(6.589±2.018)、(7.047±2.560)、(6.956±3.225)h,为注射用 1 的开发和临床应用提供了参考.
Abstract
A LC-MS/MS method was established to determine the tetrodotoxin(1)in human plasma.The Waters Atlantis HILIC Silica chromatography column(2.1 mm× 100 mm,3 μm)was used,with the mobile phase of acetonitrile-water-acetic acid.The flow rate was 0.40 mL/min,the column temperature was 40 ℃,and the injection volume was 10 μL.The linear range of this method was 0.02-5 ng/mL,and the LLOQ was 0.02 ng/mL.The human pharmacokinetic study of 1 injection was conducted for the first time,and the results were validated to meet the requirements of human pharmacokinetic research.The main pharmacokinetic parameters for a single dose of 3 dose groups(5,10,and 20 μg)were as follows:the cmax of(0.129 2±0.041 9),(0.253 7±0.036 9)and(0.530 8±0.162 6)ng/mL,the tmax of(0.321±0.144),(0.510±0.313)and(0.541±0.275)h,and the t1/2 of(6.589±2.018),(7.047±2.560)and(6.956±3.225)h,respectively,which provided a reference for the development and clinical application of 1 injection.
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