国产尼莫地平软胶囊人体相对生物利用度研究  

The relative bioavailability of domestic nimodipine soft capsule in healthy volunteers

作　　者：吴妍[1] 罗大林[1] 吕立明[1] 何海霞[2] 姚高琼[2] 雷自强[2] 朱治本[2] 周远大[2] 

机构地区：[1]重庆医科大学临床学院药剂科,重庆400016 [2]重庆医科大学临床学院临床药理研究室,重庆400016

出　　处：《重庆医科大学学报》2001年第1期78-79,82,共3页Journal of Chongqing Medical University

摘　　要：目的：研究尼莫地平软胶囊的人体相对生物利用度。方法：10名健康男性志愿者随机交叉单剂量口服国产尼莫地平软胶囊和进口尼莫通片后，用HPLC法测定血浆中尼莫地平的浓度变化情况。结果：两种制剂的体内药时数据符合二室模型，Cmax分别为27.15±9.77 ng/ml，38.02±14.83ng/ml；Tmax为1.04±0.41h，0.77±0.25h；AUC(0～12)为107.79±38.56μg/h/L，111.22±47.63μg/h/L。两种制剂的相对生物利用度比较，其生物利用度为99.92%。结论：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。Objective: A single oral dose of domestic and imported nimodipine soft capsules or nimotop tablets was given to 10 healthy volunteers in a randomized crossover study. Methods: Plasma level was determined by HPLC. Results: The results showed that the plasma level -time curve of the two preparations were two compartment model. The Cmax of nimodipine soft capsules and tablets were 27.15±9.77 ng/ml and 38.02±14.83ng/ml; Tmax were 1.04±0.41h and 0.77±0.25h; AUC(0-12) were 107.79±38.56μg/h/L and 111.22±47.63μg/h/L, respectively. Conclusion:The relative bioavailability of domestic nimodipine to imported was 99.92%. The results indicated that the two formulations were bioequivalent.

关 键 词：尼莫地平 生物利用度 高效液相色谱法 软胶囊 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]