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10名健康男性志愿者随机自身交叉单剂量口服国产尼莫地平软胶囊和进口Bayer尼莫通片后,用高效液相色谱法测定血浆中尼莫地平浓度,尼莫地平两种制剂的体内药时数据符合二室模型,Cmax分别为27.15±77,38.02±14.83ng/ml;T_(max)为1.04±0.41,0.77±0.25h;t_(1/2)β为3.68±2.14,3.09±1.41h;AUC_(0-12)为 107.79±38.56,111.22±47.63μg.hL~(-1).两种制剂的相对生物利用度比较,国产尼莫地平软胶囊,其相对生物利用度为99.92%,表明国产尼莫地平软胶囊与进口尼莫通片属生物等效制剂.
Ten healthy volunteers were randomized crossover single oral oral administration of nimodipine capsules and imported Bayer Nimotong tablets, high-performance liquid chromatography determination of nimodipine plasma concentrations of nimodipine two preparations of in vivo drug The data were in accordance with the two-compartment model with Cmax of 27.15 ± 77,38.02 ± 14.83ng / ml, T max of 1.04 ± 0.41 and 0.77 ± 0.25h, t 1/2 of β 3.68 ± 2.14, 3.09 ± 1.41 h, AUC 0-12 was 107.79 ± 38.56,111.22 ± 47.63μg.hL -1 .The relative bioavailability of the two preparations was compared with that of the domestic nimodipine soft capsule, the relative bioavailability was 99.92% , Indicating that domestic nimodipine capsules and imported nimodipine bioequivalent formulations.