国产尼莫地平软胶囊人体相对生物利用度研究  

Relative bioavailability of domestic nimodipine soft capsule in healthy volunteers

作　　者：朱治本[1] 何海霞[1] 姚高琼[1] 周远大[1] 雷自强[1] 

机构地区：[1]重庆医科大学第一医院药剂科临床药理研究室,重庆400016

出　　处：《儿科药学》1999年第4期15-17,共3页Journal of Pediatric Pharmacy

摘　　要：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.A single oral dose of domestic and imported nimodipine soft capsules or tablets was given to 10 healthy volunteers in a randomized crossover study. Drug concentrations in plasma were determined by HPLC method. The results showed that plasma concentration - time curve of the two preparations were to a two compartment model. The Cmax of nimodipine soft capsules and tablets were 27. 15 ± 9. 77 and 38. 02 ± 14. 83ng/ml; Tmax were 1. 04± 0. 41and 0. 77± 0. 25h; t1/2β were 3. 68 ±2. 14 and 3. 09 ± 1. 41h; AUC(0-12) were 107. 79 ±38. 56 and 111. 22± 47. 63μg. h. L-1, respectively. The relative bioavailability of domestic nimodipine to imported was 99. 92%. The results suggested that the two formulations were bioe-quivalent.

关 键 词：尼莫地平 相对生物利用度 高效液相色谱法 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]