高效液相色谱法测定维生素E烟酸酯软胶囊的血药浓度  

Determination of Plasma Concentration of Vitamin E Nicotinate by HPLC

作　　者：胡晓静 

机构地区：[1]北京医药集团教育培训中心,北京市丰台区宋家庄苇子坑148号100079

出　　处：《光谱实验室》2014年第2期250-253,共4页Chinese Journal of Spectroscopy Laboratory

摘　　要：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。健康志愿者18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120h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。维生素E烟酸酯在0．02-10．0μg/mL范围内线性关系良好（r=0．9992），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％。主要药动学参数为：维生素E烟酸酯软胶囊的Cmax为1．24±0．20（μg，mL）；Tmax为5．78±0．65（h）；t1/2（ke）为33．99±3．36（h）：AU C0-120为33．92±2．14（μg／mL·h）；AUC0-∞为37．62±2．81（μg／mL·h）：本方法灵敏度高，选择性、重复性好，可准确测定人血浆中维生素E烟酸酯的浓度。A HPLC method for determining vitamin E nicotinate in plasma was developed, the pharmacokinetics of single oral dose vitamin E nicotinate soft capsule in healthy volunteers were investigated. A single oral dose （0.6g） was given to 18 healthy volunteers. Venous blood at different time points were collected in 120h after administration. The concentrations of vitamin E nicotinate in plasma were determined by HPLC. Assay linearity was obtained in the range of 0.02--10.0~g/mL （r = 0.9992） . The relative recoveries of vitamin E nicotinate were in the range of 85%--115%. The absolute recovery was more than 70%. The intraday and inter day RSD were both less than 15%. Its main pharmacokinetic parameters were as follows： Cmax：1.24±0.20 （μg/mL） ; Tmax： 5.78±0.65 （h）; t1/2（ke）： 33.99±3.36 （h）; AUC（0-120） ：33.92±2.14 （μg/mL.h）; AUC t0-∞ ：37.62±2.81 （μg/mL.h） respectively. The method developed is high sensitivity, good selectivity and reproducibility for accurate determination of the plasma concentration of vitamin E nicotinate in human.

关 键 词：维生素E烟酸酯 高效液相色谱法 

分 类 号：O657.72[理学—分析化学]