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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 a method for the determination of vitamin E nicotinate in human plasma by high performance liquid chromatography (HPLC) and study the pharmacokinetics of vitamin E nicotinate soft capsule in healthy volunteers. Methods: Twenty healthy volunteers were given oral single dose of vitamin E nicotinate soft capsule 0.6g, and venous blood samples were taken within 36h after taking the drug. The contents of vitamin E nicotinate in plasma were determined by high performance liquid chromatography (HPLC) concentration. DAS pharmacokinetic program to calculate pharmacokinetic parameters, analysis of the body’s pharmacokinetics. Results: The linear range of vitamin E nicotinate was in the range of 25.0-2000.0 μg · L-1 (r = 0.9999), the relative recoveries ranged from 85% to 115% and the absolute recoveries were over 70% Between the variation is less than 15%. The plasma concentration-time curve of vitamin E nicotinate conformed to the two-compartment model. The main pharmacokinetic parameters were as follows: tmax was (5.1 ± 0.6) h; Cmax was (1094.6 ± 290.8) μg · L-1; 2 were (8.0 ± 0.8) h; AUC (0-36) and AUC (0-inf) were (10953.5 ± 2184.2) μg · h · L-1 and (11532.9 ± 2184.3) μg · h · L-1, respectively. Conclusion: This method has high sensitivity, good selectivity and repeatability. It can accurately determine the concentration of vitamin E nicotinate in human plasma and is suitable for pharmacokinetic studies.