维生素E烟酸酯胶囊在健康志愿者的生物等效性  

Bioequivalence of vitamin E nicotinate capsule in healthy volunteers

作　　者：谷清[1] 张佳丽[1] 吴华[1] 潘世芬[1] 王华光[1] 冯文利[1] 王鹤尧[1] 

机构地区：[1]首都医科大学附属北京朝阳医院药事部,北京100020

出　　处：《中国临床药理学杂志》2008年第3期216-219,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究维生素E烟酸酯胶囊(抗氧化剂)在健康志愿者体内的相对生物利用度并评价其生物等效性。方法采用双周期随机交叉给药方法,22名健康男性志愿者分别单剂量口服试验和参比的维生素E烟酸酯胶囊0.2g。用HPLC-MS法测定血浆药物浓度,计算2者的药代动力学参数及相对生物利用度,经统计分析进行生物等效性判定。结果单剂量口服维生素E烟酸酯胶囊试验制剂和参比制剂0.2g后,主要药代动力学参数:Cmax分别为(413.8±245.5)、(383.1±164.9)ng.mL-1;tmax分别为(5.09±0.43)、(5.23±0.61)h;AUC0-48分别为(1641.5±1042.6)、(1654.9±772.3)ng.h.mL-1;AUC0-∞分别为(1654.2±1055.9)、(1672.6±790.8)ng.h.mL-1。试验制剂的相对生物利用度为(99.41±34.62)%。结论2种维生素E烟酸酯制剂具有生物等效性。Objective To study the relative bioavailability and to evaluate bioequivalence of vitamin E nicotinate in healthy volunteers. Methods A single oral dose of 0.2 g test and reference vitamin E nicotinate capsule were given to 22 healthy male volunteers respectively in double periods, randomized crossover study. The concentrations of vitamin E nicotinate in plasma were determined by HPLC - MS. The pharmacokinetic paramters and relative bioavailability were calculated, then the bioequivalence was judged by statistical analysis. Results The main pharmacokinetic parameters after a single oral administration of 0.2 g test and reference formulations were as follows： Cmax were （413. 8± 245.5 ） and （383.1 ± 164.9） ng· mL^-1, tin=were （5.09± 0.43） and （5.23± 0.61） h, AUC0-48 were （ 1641.5± 1042.6） and （ 1654.9 ± 772.3） ng·h· mL^-1, AUC0-∞ were （1654.2± 1055.9） and （1672.6 ± 790.8 ） ng·h·mL^-l, respectively. The relative bioavailability of test drug was （99.41± 34.62）%. Conclusion The test and reference vitamin E nicotinate capsules were bioequivalent.

关 键 词：维生素E烟酸酯胶囊 生物等效性 高效液相色谱-质谱联用 

分 类 号：R969.1[医药卫生—药理学] R977.25[医药卫生—药学]