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目的 :对珠海许瓦兹公司生产的单硝酸异山梨酯缓释胶囊与德国麦克乐公司生产的缓释胶囊和瑞士阿斯特拉公司生产的缓释片剂进行药物动力学比较。方法 :采用气相色谱法 ,以对硝基苯乙腈为内标 ,测定受试者体内单硝酸异山梨酯 ( 5-ISMN )的血浆浓度 ,计算药物动力学参数。方法的线性范围为 :10～ 10 0 0 μg·L- 1,回收率为 ( 10 0± 3) % ;精密度RSD为 2 .3%。结果 :本品和缓释胶囊比较 ,AUC ,Cmax,T1/ 2 ,MRT ,MAT (P >0 .0 5) ,而在C10min,C2 0min,C30min,C4 5min,C60min,Tmax,Tlag(P <0 .0 5)。与缓释片比较 ,AUC ,Cmax,Tmax,T1/ 2 ,Tlag,MAT(P >0 .0 5) ,而在MRT ,C2 0min,C30min(P<0 .0 5)。结论 :本品的吸收显著快于 2种对照制剂
OBJECTIVE: To compare the pharmacokinetics of isosorbide mononitrate sustained-release capsules produced by Schweiss Co., Ltd. in Zhuhai with the sustained-release capsules manufactured by Macleod Co., Germany and the sustained release tablets produced by Astra Swiss. Methods: The plasma concentrations of isosorbide mononitrate (5-ISMN) were measured by gas chromatography with p-nitrophenylacetonitrile as internal standard to calculate the pharmacokinetic parameters. The linear range of the method was 10 ~ 100 μg · L -1, the recovery was (100 ± 3)%, and the precision RSD was 2.3%. Results: Compared with sustained - release capsules, AUC, Cmax, T1 / 2, MRT and MAT (P> 0.05) 0 .0 5). Compared with sustained release tablets, AUC, Cmax, Tmax, T1 / 2, Tlag, MAT (P> 0.05) and MRT, C2 0min, C30min (P <0.05). Conclusion: This product absorption was significantly faster than the two control preparations