【作者】 刘慧； 王本杰； 郭瑞臣；

【Author】 Liu hui, Wang Ben-jie Guo Rei-chen (Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012

【机构】 山东大学齐鲁医院临床药理研究所；

【摘要】 目的:对健康志愿者进行维生素E的药物动力学研究,以评价胶丸剂的生物等效性。方法: 20名健康志愿者,随机分为二组,取血浆4ml经去蛋白预处理后,采用荧光法测定维生素E经时血浓度。维生素E血浓度-时间数据经处理,得试验制剂和参比制剂的药代动力学参数。并以AUC0～24求了出试验制剂的相对生物利用度。同时对主要药代动力学参数进行方差分析、双单侧t检验和(1-2α)置信区间分析,评价试验制剂和参比制剂的生物等效性。结果:试验制剂和参比制剂主要药代动力学参数t1/2分别为8.32±1.21h和8.13±1.25h,Tmax分别为4.00±0.32h和4.10±0.38h,Cmax分别为19.12±5.25μg.ml-1和19.26±5.46μg·ml-1,AUC0～24分别为170.35±69.43μg·ml-1·h和168.03±74.60μg·ml-1·h,AUC0- 分别为200.73±85.57μg·ml-1·h和198.80±93.01μg·ml-1·h,试验制剂维生素E烟酸酯胶丸相对生物利用度F为102.91%±8.77%。结论:RP-HPLC荧光法测定人血浆中维生素E的浓度, 灵敏度高,适用于维生素E血浓度测定及其药代动力学研究。试验制剂和参比制剂为生物等效制剂。更多还原

【Abstract】 OBJECTIVE: To study the pharmacokinetics of Vitamin E nicotinate in healthy volunteers and to evaluate the bioavailability of the Vitamin E nicotinate soft capsule and market Vitamin E nicotinate capsule. METHODS: Twenty healthy volunteers, divided into two groups in random, the volunteers were randomized to receive eight test preparation or reference preparations 300mg. Take plasma 4ml after re-protein. Determine the Vitamin concentration through hours by HPLC method. By analyzing the Vitamin E-time data, you can get the pharmacokinetics parameters of test preparation and reference preparation, and get the relative bioavailability of the test preparation according to AUC0-24 analysis the main pharmacokinetic parameters, single and double side T test examination and (1-2 α ) confidence interval, to evaluate the bioavailability of the test preparation and reference preparation. RESULTS:The main pharmacokinetics parameter of test preparation and reference preparation were sa follows, t1/2 8.32 ± 1.21h and 8.13 ± 1.25h, Tmax 4.00±0.32h and 4.10±0.38h, Cmax 19.12 ± 5.25 μ g·ml-1 and 19.26±5.46 μ g·ml-1, AUC0-24 170.35 ± 69.43 μg·ml-1 · h and 168.03±74.60μ g·ml-1 · h, AUC0-β200.73±85.57 μ g·ml-1 · h and 198.80±93.01 μ g·ml-1 · h, bioavailabilities of Vitamin E are 102.91%±8.77%. CONCLUSION: The Vitamin E concentration in human plasma by RP-HPLC fluorescence measure, which is a method with high sensitivity, simple and feasibility. It is suitable for the determination of Vitamin E concentration in human plasma and its research in pharmacokinetics and bioavailability.更多还原