摘要
采用毛细管气相色谱法测定硝酸异山梨酯血药浓度 ,考察了国产及进口硝酸异山梨酯缓释胶囊多剂量口服达稳态过程和稳态药物动力学特征 ,研究硝酸异山梨酯缓释胶囊的人体药物动力学和相对生物利用度。结果表明 ,连续口服硝酸异山梨酯 4 0 mg缓释胶囊三天后 ,体内硝酸异山梨酯血药浓度基本达稳态水平。国产和进口缓释胶囊的稳态药物动力学参数 tmax分别为 4 .33± 0 .4 9和 3.83± 0 .72 h,Cmax分别为 2 4 .78± 8.2 9和 2 4 .4 2± 7.39ng/ ml,AUCss分别为 14 7.5± 18.4和 14 6 .9± 15 .7ng· h· m l- 1 ,波动度 DF分别为 3.5 4± 0 .82和 3.5 2± 0 .81。国产制剂的相对生物利用度为 10 0 .5 %± 8.1% ,经三因素方差分析和双单侧
A capillary gas chromatography method with electron captured detector was established for the determination of isosorbide dinitrate in plasma after multiple administration of a daily dose of 40mg isosorbide dinitrate domestic and imported sustained release capsules in a randomized crossover design. The fluctuation of isosorbide dinitrate valley concentrations was observed and the steady state pharmacokinetics was characterized in a multiple dose schedule of 40mg isosorbide dinitrate sustained release capsules. The steady state of isosorbide dinitrate plasma concentration was reached in three days oral administration. The relative bioavailiability of multiple oral dose of 40mg domestic capsules was 100.5%± 8.1%. The results of statistical evaluation by three factor variance analysis and two one sided t test showed that two brands capsules were bioequivalent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2002年第11期546-549,共4页
Chinese Journal of Pharmaceuticals
关键词
硝酸异山梨酯
缓释胶囊
药物动力学
相对生物利用度
isosorbide dinitrate
sustained release capsule
pharmacokinetics
relative bioavailability
