【摘要】 目的 :以进口尼莫地平片 (内含尼莫地平 30mg)为对照 ,考察国产制剂的人体生物等效性。方法 :2 0名男性健康受试者采用随机交叉给药方案 ,分别口服国产和进口尼莫地平片 ,用HPLC法测定血浆中尼莫地平的浓度。结果 :用 3P97软件进行房室模型拟合 ,并计算其t1 2 、梯形法计算AUC0～∝ 及计算Cmax和Tmax。国产片与进口片的Tmax分别为 (0 .90± 0 .38)和 (0 .93± 0 .4 1)h ,Cmax分别为 (2 1.11± 9.38)及 (2 2 .78± 10 .90 )ng·L- 1 ,t1 2 分别为 (1.84± 1.37)及 (1.6 5± 0 .90 )h ,AUC0～t分别为 (44 .74± 17.4 6 )及 (43.5 4± 19.71)ng·h·L- 1 。结论 :2种片剂的主要药代动力学参数经检验无统计学差异 (P >0 .0 5 ) ,相对生物利用度为 (110 .5 3± 34.0 7) % ,AUC0～t与Cmax经生物等效性分析证明 2种制剂生物等效。更多还原

【Abstract】 Objective:To evaluate the bioequivalence of 30mg domestic and imported nimodipine tablets.Methods:A single oral administration of 30mg domestic and imported nimodipine were given to 20 healthy young male volunteers.Results:The pharmacokinetic parameters for two kind of tablets were calculated as the follows: T max =(0.90± 0.38), (0.93±0.41)h, C max =(21.11±9.38), (22.78± 10.90) ng·L -1 , t 1/2 =(1.84±1.37), (1.65± 0.90)h, AUC 0～t =(44.74±17.46),(43.54± 19.71) ng·h·L -1 .Conclusion:No statistical differences were observed between these two preparations,the results showed that the two preparations were bioequivalent.更多还原