国产格列美脲片在人体内的药动学及相对生物利用度  

Relative bioavailability and pharmacokinetics of domestic glimpiride tablets in volunteers

作　　者：王萍[1] 丁林鸿 郭振波 黄民[3] 

机构地区：[1]贵阳医学院附属医院,贵州贵阳550004 [2]贵州圣济堂制药有限公司,贵州贵阳550001 [3]中山医科大学临床药理学研究所,广东广州510080

出　　处：《中国医院药学杂志》2003年第4期213-215,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :在 10名健康志愿者体内研究了国产格列美脲片和进口对照片的药动学和生物利用度。方法 :受试者交叉自身对照分别口服单剂量受试片或参比片各 4mg,采用高效液相色谱法检测血药浓度。结果 :国产片和对照片主要药动学参数 :Cmax分别为 (4 15 .6± 10 7.3)和 (4 0 6 .3± 15 0 .1) μg·L-1;Tmax分别为 (3.1± 0 .5 )和 (3.2± 0 .7)h ;T1/2 分别为 (7.3± 1.5 )和 (7.5± 1.7)h;AUC0→t分别为 (2 4 39.8± 5 98.5 )和 (2 2 2 6 .1± 4 5 8.9) μg·L-1·h ;AUC0→∞ 分别为 (2 6 35 .4± 6 5 5 .8)和 (2 4 0 2 .4± 4 6 3.9) μg·L-1·h。受试片与参比片比较 ,生物利用度F为 (110 .8± 18.1) %。结论 :统计学结果显示 ,两制剂具有生物等效性。ABSTRACT:OBJECTIVE The pharmacokinetics and bioavailability of glimpiride tablets were compared with those of imported aventis tablets.METHODS Plasma levels of glimepiride were detected by HPLC UV method.RESULTS The parameters of the two formulations for glimepiride: C max of domestic and imported tablets were ( 415.6 ± 107.3 ) and ( 406.3 ± 150.1 ) μg·L -1 ; T max ( 3.1 ± 0.5 ) and ( 3.2 ± 0.7 ) h; T 1/2 ( 7.3 ± 1.3 ) and ( 7.5 ± 1.7 ) h;AUC 0→t ( 2439.8 ± 598.5 ) and ( 2226.1 ± 458.9 ) μg·L -1 ·h;AUC 0→∞ ( 2635.4 ± 655.8 ) and ( 2402.4 ± 463.9 ) μg·L -1 ·h,respectively.The relative bioavailability of domestic tablets was ( 110.8 ± 18.1 )%.CONCLUSIONS The results of statistics analysis demonstrated that two tablets were bioequivalent.

关 键 词：国产 格列美脲片 人体内 药动学 相对生物利用度 

分 类 号：R969.1[医药卫生—药理学]