本文選題：吡嘧司特鉀片 + 藥動學(xué)　； 參考：《中國新藥雜志》2015年02期

【摘要】：目的:建立人血漿中吡嘧司特鉀濃度的LC-MS/MS測定法,研究吡嘧司特鉀片在中國健康人體內(nèi)的藥動學(xué)。方法:21例中國男性健康受試者單劑量空腹口服10 mg吡嘧司特鉀片,0~24 h間隔采集肘靜脈血,血漿樣品采用0.1%鹽酸化乙腈沉淀蛋白處理,LC-MS/MS法測定吡嘧司特鉀血藥濃度,DAS 2.0軟件計算藥動學(xué)參數(shù)。結(jié)果:建立的LC-MS/MS法測定吡嘧司特鉀血漿濃度在2.0~400 ng·m L-1范圍內(nèi)線性關(guān)系良好,最低定量限為2.0 ng·m L-1,經(jīng)方法驗證符合生物樣品測定要求。測得受試者單劑量口服10 mg吡嘧司特鉀片后的主要藥動學(xué)參數(shù):Cmax為(1 007±135)ng·m L-1,Tmax為(1.8±0.6)h,t1/2為(4.1±0.8)h,AUC0~24為(5 851±992)ng·h·m L-1,AUC0~∞為(5 986±1 068)ng·h·m L-1,CL為(1.8±0.3)L·h-1,Vd為(10.5±1.5)L。結(jié)論:建立的LC-MS/MS測定法專屬、靈敏,滿足吡嘧司特鉀片藥動學(xué)研究的要求。
[Abstract]:Objective: to establish a LC-MS/MS determination method for the concentration of pyridin potassium in human plasma and to study the pharmacokinetics of Pemirolast potassium tablets in Chinese healthy volunteers. Methods: 21 Chinese male healthy subjects were treated with a single dose of 10 mg Pemirolast potassium tablets, 0~24 h interval and 0.1% hydrochloric acetonitrile precipitated protein, and the plasma samples were treated with 0.1% hydrochloric acetonitrile precipitating protein. LC-MS/MS method was used to determine the concentration of ppipyridine potassium and DAS 2 software to calculate the pharmacokinetic parameters. Results: the LC-MS/MS method was used to determine the plasma concentration of pyridin potassium in the 2.0~400 ng. M L-1, and the minimum quantitative limit was 2 ng. M L-1. The method was proved to be in accordance with the requirements of biological samples. The single dose of 10 of the subjects was 10. Mg Pemirolast potassium tablets's main pharmacokinetic parameters: Cmax (1007 + 135) ng / m L-1, Tmax (1.8 + 0.6) h, t1/2 (4.1 + 0.8) h, AUC0~24 for (5851 + 992) ng H. Requirements for pharmacokinetic studies.

【作者單位】： 中國藥科大學(xué)藥物分析教研室;中國醫(yī)學(xué)科學(xué)院皮膚病醫(yī)院;
【分類號】：R969.1
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本文編號：1811599