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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 t检验判定两种制剂具有生物等效性
The plasma concentration of isosorbide dinitrate was determined by capillary gas chromatography. The steady-state pharmacokinetics and pharmacokinetics of domestic and imported isosorbide dinitrate sustained-release capsules were investigated. The effects of isosorbide dinitrate sustained-release capsules Human pharmacokinetics and relative bioavailability. The results showed that the concentration of isosorbide dinitrate in plasma reached steady state after three consecutive days with isosorbide dinitrate 4 0 mg sustained release capsules. The steady-state pharmacokinetic parameters of domestic and imported sustained release capsules tmax were 4.33 ± 0.49 and 3.83 ± 0.72 h, Cmax were 24.78 ± 8.29 and 24.4 ± 7.39 ng / ml and AUCss were 14 7.5 ± 18.4 and 14 6 .9 ± 15 .7 ng · h · m l-1, respectively. The volatility DF was 3.5 4 ± 0.82 and 3.5 2 ± 0.81, respectively. The relative bioavailability of domestic preparations was 100.5% ± 8.1%. The bioequivalence of the two preparations was judged by three-way ANOVA and double unilateral t-test