维生素E烟酸酯软胶囊的血药浓度测定及健康志愿者体内的药动学  

Determination of plasma concentration of vitamin E nicotinate and its pharmacokinetics in healthy Chinese volunteers

作　　者：陈冰冰[1] 胡卢丰[1] 邱相君[2] 代宗顺[3] 胡国新[1] 

机构地区：[1]温州医学院药理学教研室,浙江温州325027 [2]河南科技大学医学院药理学教研室,河南洛阳471003 [3]华中科技大学同济医学院临床药理研究所,湖北武汉430030

出　　处：《中国医院药学杂志》2009年第9期721-724,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:建立人血浆中维生素E烟酸酯浓度的高效液相色谱测定方法,研究单剂量口服维生素E烟酸酯软胶囊后健康志愿者体内的药动学过程。方法:健康志愿者20名,经单剂量口服维生素E烟酸酯软胶囊0.6g,分别于服药后36h内多点抽取静脉血;高效液相色谱(HPLC)法测定血浆中维生素E烟酸酯的浓度。DAS药动学程序计算药动学参数,分析体内的药动学过程。结果:维生素E烟酸酯在25.0～2000.0μg·L-1范围内线性关系良好(r=0.9999),相对回收率均在85%～115%范围内,绝对回收率大于70%;日内和日间变异均小于15%。维生素E烟酸酯的血药浓度-时间曲线符合二室房室模型,主要药动学参数为:tmax为(5.1±0.6)h;Cmax为(1094.6±290.8)μg·L-1;t1/2为(8.0±0.8)h;AUC(0-36)、AUC(0-inf)分别为(10953.5±2184.2)μg·h·L-1和(11532.9±2184.3)μg·h·L-1。结论:本方法灵敏度高,选择性好和重复性佳,可准确测定人血浆中维生素E烟酸酯的浓度,适合药动学研究。OBJECTIVE To establish the high performance liquid chromatogram （HPLC） method for determining vitamin E nicotinate in healthy volunteers and study its pharmacokinetics process. METHODS A single oral dose （0. 6 g） was given to 20 healthy volunteers in a randomised study. Collect venous blood at different time points in 36 h after administration. The concentrations of vitamin E nicotinate in plasma were determined by high performance liquid chromatography （HPLC）. Calculate and evaluate the pharmacokinetics parameters of vitamin E nicotinate in human by DAS program. RESULTS Assay linearity was obtained in the range of （25.0-2000. 0） g·L^-1 （r = 0. 999 9）. The relative recovery of vitamin E nicotinate from Human plasma was in the range of （85-115） %. The absolute recovery was more than 70%. The intraday and interday relative standard deviations （RSD） were both less than 15 %. The concentration-time curve was fittedto a-two-compartment model. Its main pharmacokinetic parameters were as follows： Tmax were （5.1±0. 6） h; Cmax were （1 094. 6±290. 8） μg·L^-1 ; T1/2 were （8. 0±0. 8） h; AUC（0-36） ; AUC（0-inf） were （10 953.5 ±2184. 2） μg·h·L^-1 and （11 532. 8±2184. 3） μg·h·L^-1 , respectively. CONCLUSION The method developed in this report had high sensitivity, good selectivity and reproducibility for accurate determination of the plasma concentration of vitamin E nicotinate in human, and fit to the pharmacokinetics study.

关 键 词：维生素E烟酸酯 高效液相色谱法 药动学 

分 类 号：R969.1[医药卫生—药理学]