盐酸阿夫唑嗪缓释片的人体生物等效性研究
Bioequivalence of Alfuzosin Hydrochloride Sustained-release Tablets in Healthy Volunteers
李欣 1杜丽娜2
作者信息
- 1. 100853,北京,解放军总医院药品保障中心
- 2. 100950,北京,军事医学科学院放射与辐射医学研究所
- 折叠
摘要
目的 考察自制盐酸阿夫唑嗪缓释片及其市售制剂在健康人体的相对生物利用度及生物等效性.方法 采用双周期自身随机交叉试验设计.20名健康男性志愿者口服受试制剂或参比制剂,血药浓度采用液相色谱一串联质谱测定.结果 受试制剂及参比制剂的主要药动学参数为:Cmax分别为(16.8±5.9)和(17.5±5.7)ng/ml;Tmax分别为(4.1±1.5)和(4.5±1.2)h;t1/2分别为(8.5±1.7)和(8.6±1.8)h;AUC(0-48h)分别为(208±61)和(210±56)ng·h/m1;AUC(0-00)分别为(221±64)和(224±61)mg·h/MI;以AUC(o-48h)计算,受试制剂的相对生物利用度为(101.5±24.1)%.结论 受试制剂和参比制剂具有生物等效性.
Abstract
Objective To evaluate the relative bioavailability and bioequivalence between two kinds of alfuzosin hydrochloride sustained-release tablets. Methods The self-made sustained-release tablets or reference formulation were given orally to 20 healthy volunteers in a two-crossover test. Drug concentrations in plasma were determined by LC-MS-MS. Results The main pharmacokinetie parameters of the self-made sustained-release tablets and reference formulation were as follows: Cmaxwas (16.8 ±5.9)and (17.5 ±5.7) ng/ml; Tmax was (4.1 ±1.5) and (4.5 ± 1.2) h; t 1/2 was (8.5 ± 1.7) and(8.6 ± 1. 8) h,AUC(0-4sh) was (208 ±61 ) and (210 ±56) ng ·h/ml,AUC(0-∞) was (221 ± 64) and (224 ±61) mg ·h/ml. The relative bioavailability was (101.5 ± 24.1 ) ％, Conclusion The test preparation is bioequivalent to the reference preparation.
关键词
盐酸阿夫唑嗪缓释片/液相色谱-串联质谱法/生物等效性Key words
alfuzosin hydrochloride sustained-release tablets/LC-MS-MS/bioequivalence引用本文复制引用
出版年
2011
NETL
NSTL
维普
万方数据