LC-MS/MS法测定人血浆中三氟柳浓度及药动学  

Determination of triflusal in human plasma by LC-MS / MS and its pharmacokinetics

作　　者：彭莉[1,2] 丁莉坤 贾艳艳 杨林 葛洁 王茂湖 文爱东 张杰[1] 

机构地区：[1]西安交通大学医学部药学院,西安710061 [2]第四军医大学第一附属医院药剂科,西安710032

出　　处：《中国新药杂志》2015年第1期27-30,73,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZXJ09202-013)

摘　　要：目的:建立液相色谱-串联质谱法(LC-MS/MS)测定三氟柳血药浓度的方法,并用于研究三氟柳胶囊在健康人体内的药动学特征。研究口服三氟柳胶囊低、中、高3个剂量给药后,三氟柳在健康人体内的药动学特征。方法:将36例健康受试者平行随机分为低、中、高3组,分别低剂量组单次口服三氟柳胶囊300 mg(1粒);中剂量组单次口服600 mg(2粒),高剂量组单次口服900 mg(3粒)。给药后用LC-MS/MS测定人体的三氟柳血药浓度,并评价三氟柳在人体的药动学特征。结果:特异性结果显示,内源性物质不干扰样本的测定,定量下限、精密度、回收率、基质效应及稳定性均符合生物样本分析要求。口服给药三氟柳胶囊后,低、中、高剂量组的主要的药动学参数测定结果如下:tmax分别为0.55,0.61,0.67 h;Cmax分别为3.31,10.85,13.22μg·m L-1;AUC0-10分别为3.92,13.18,19.51 mg·h·L-1。结论:本研究建立的LC-MS/MS方法测定准确、专属性强、灵敏度高,适用于三氟柳胶囊药动学的研究。Objectives： To establish an LC-MS/MS method to determine the concentration of triflusal in human plasma, and to evaluate the pharmacokinetics of triflusal capsules in Chinese healthy volunteers. Methods： Thirty-six healthy volunteers were divided into three groups, taking 300, 600, and 900 mg triflusal capsules, respectively. After oral dose, the concentrations of triflusal in plasma were detected by LC-MS/MS and pharmacokinetics were evaluated. Results： Triflusal determinations in plasma were not interfered by the endogenous substances. The quantitative limit, precision, recovery rate, the matrix effect and stability were conform to the requirements of analysis in biological samples. The main pharmacokinetic parameters were： Tmax, 0. 55, 0. 61 and 0.67h; C 3.31, 10.85 and 13.22μg·mL-1; AUC0-10, 3.92, 13.18 and 19. 51mg.h.L-1. Conclusions： The method is simply, accurant and selective, and suitable for pharmacokinetic study of triflusal capsules.

关 键 词：三氟柳胶囊 液相色谱-串联质谱法 药动学 

分 类 号：R973.2[医药卫生—药品]