摘要
目的 :选择 12名男性健康志愿者 ,进行单剂量口服硝酸异山梨醇酯缓释胶囊的人体药动学研究。方法 :采用毛细管气相色谱法 ,测定单剂量口服 4 0mg国产与进口硝酸异山梨醇酯缓释胶囊在健康人体内的硝酸异山梨醇酯浓度。结果 :硝酸异山梨醇酯缓释胶囊的体内动态过程呈一级吸收的二房室开放模型 ,国产与进口缓释胶囊的Cmax分别为 (2 3.6± 6 .2 ) μg·L-1和 (2 3.7± 5 .1) μg·L-1,tmax分别为 (3.3± 0 .6 )h和 (3.8± 0 .6 )h ,MRT分别为 (9.1± 0 .8)h和 (9.1± 0 .7)h ,t1/ 2 分别为 (8.2± 1.0 )h和 (8.1± 0 .9)h ,AUC0～ 2 4分别为 (12 6 .3± 15 .4 ) μg·h·L-1和 (12 4 .0± 14 .1) μg·h·L-1,AUC0→∞ 分别为 (139.4±14 .8) μg·h·L-1和 (136 .7± 13.8) μg·h·L-1。结论
OBJECTIVE To investigate the clinical pharmacokinetics of isosorbide dinitrate sustained release capsules in healthy volunteers. METHODS A capillary gas chromatography (CGC) was established for the determination of isosorbide dinitrate in plasma after a single oral dose of 40mg domestic and imported isosorbide dinitrate sustained release capsules in a randomized crossover design. RESULTS The dynamic course of isosorbide dinitrate plasma concentrations conformed to a two compartment open model with a 3P87 program and the main pharmacokinetic parameters after a single oral dose of 40 mg domestic and imported sustained release capsules were as follows: C max were ( 23.6 ± 6.2 )μg·L -1 and ( 23.7 ± 5.1 )μg·L -1 , t max were ( 3.3 ± 0.6 )h and ( 3.8 ± 0.6 )h, MRT were ( 9.1 ± 0.8 )h and ( 9.1 ± 0.7 )h, t 1/2 were ( 8.2 ± 1.0 )h and ( 8.1 ± 0.9 )h, AUC 0～24 were ( 126.3 ± 15.4 )μg·h·L -1 and ( 124.0 ± 14.1 )μg·h·L -1 ,AUC 0→∞ were ( 139.4 ± 14.8 )μg·h·L -1 and ( 136.7 ± 13.8 )μg·h·L -1 , respectively. CONCLUSIONS The domestic and imported sustained release capsules were similar in pharmacokinetic characteristics.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第2期72-74,共3页
Chinese Journal of Hospital Pharmacy
关键词
硝酸异山梨醇酯
缓释胶囊
药动学
毛细管气相色谱法
isosorbide dinitrate
sustained release capsules
pharmacokinetics
capillary gas chromatography
