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采用毛细管气相色谱法测定18名健康男性志愿者多剂量交叉口服40mg国产5-单硝酸异山梨醇酯缓释片和进口5-单硝酸异山梨醇酯缓释胶囊后的血药浓度变化情况。单剂量研究结果表明,缓释片与缓释胶囊的Ka分别是0.2479h-1与0.2504h-1;Ke分别是0.1403h-1与0.137h-1;tmax分别是5.35h与5.36h;Cmax分别是377.09ng/ml与351.98ng/ml,缓释片的相对生物利用度为106.28%。多剂量研究结果表明缓释片与缓释胶囊的波动系数分别是1.97与1.86。
The plasma concentrations of 40mg domestic isosorbide 5-mononitrate sustained release tablets and imported 5-isosorbide mononitrate sustained release capsules were measured by capillary gas chromatography in 18 healthy male volunteers. The results of single-dose study showed that the Ka of sustained-release tablets and sustained-release capsules were 0.2479h-1 and 0.2504h-1, respectively; Ke values were 0.1403h-1 and 0.137h-1, respectively, and tmax were 5.35h and 5h .36h; Cmax respectively 377.09ng / ml and 351.98ng / ml, the relative bioavailability of sustained release tablets was 106.28%. The multi-dose study showed that the coefficient of variation of sustained-release tablets and sustained-release capsules were 1.97 and 1.86, respectively.