摘要
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 isosorbide-5-mononitrate (IS-5-MN) concentrations in plasma were determined by CGC-ECD method following a oral multi-dose of China-made IS-5-MN sustained releasetablet and imported IS-5-MN sustained release capsule given to 18 healthy male volunteers in aopen randomized cross-over test. The mono-dose test showed that Ka values of the tablet and thecapsule were 0 .247 9 h- 1 and 0 .250 4 h-1, Ke 0. 140 3 h- 1 and 0. 137 9 h-1, tmax 5 .35 h and5. 36h; Cmax 377. 09 ng/ml and 351. 98 ng/ml, respectively. The relative bioavailability of IS-5MN sustained release tablet was 106.28%. And the multi-dose test showed that the fluctuationindex of the tablet and the capsule was 1.97 and 1. 86, respectively.
