都可喜人体药动学研究

Pharmacokinetics of Duxil in healthy volunteers

目的 :研究 10名健康志愿者口服都可喜 (阿米三嗪 /萝巴新 )后阿米三嗪和萝巴新的药动学。方法 :分别采用高效液相色谱法紫外检测器和高效液相色谱法荧光检测器测定血浆中阿米三嗪和萝巴新浓度。结果 :经 3P87药动学计算程序处理拟合 ,两者皆符合口服给药二室开放模型 ,其药动学参数为 :阿米三嗪的AUC为 (34 174.91± 2 335 .17) μg·h·L-1,tmax为 (3.81± 0 .76 )h ,cmax为 (816 .76± 70 .0 7) μg·L-1;萝巴新的AUC为 (1116 .15± 81.85 ) μg·h·L-1,tmax为 (1.2 7± 0 .2 2 )h ,cmax为(374.0 4± 71.71) μg·L-1。结论 :此研究为临床提供了药动学参数及生物利用度研究的方法。

OBJECTIVE:The pharmacokinetics of Duxil (almitrine/raubasine) were studied in ten healthy volunteers after a single oral dose.METHODS:The plasma concentrations of almitrine and raubasine were determined by means of high performance liquid chromatography.RESULTS:The concentration time curves of almitrine and raubasine were fitted to a 2 compartment model.The pharmacokinetic parameters of almitrine and raubasine were calculated as following:almitrine: AUC (34174.91±2335.17) μg·h·L -1 , t max (3.81±0.76) h, c max (816.76±70.07) μg·L -1 ;raubasine: AUC (1116.15±81.85) μg·h·L -1 , t max (1.27±0.22) h, c max (374.04±71.71) μg·L -1 .CONCLUSION:This study provides the pharmacokintic parameters for clinical and is benefical to rational use of duxil.