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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。
OBJECTIVE: To compare the bioequivalence of domestic preparations with nimodipine tablets (containing nimodipine 30mg) as control. Methods: Twenty male healthy volunteers were randomized to receive oral administration of nimodipine tablets. The plasma nimodipine concentrations were determined by HPLC. Results: Atrial compartment model fitting was performed with 3P97 software and t1 2 was calculated. Trapezoidal method was used to calculate AUC0 ~ α and Cmax and Tmax were calculated. The Tmax of domestic and imported tablets were (0.90 ± 0.38) and (0.93 ± 0.41) h, respectively, with Cmax of (2.11.1 ± 9.38) and (2.78 ± 10.90 ) ng · L-1, t1 2 were (1.84 ± 1.37) and (1.6 5 ± 0.90) h respectively, and the AUC0 ~ t were (44.74 ± 17.46) and (43.54 ± 19.71) ng · h · L- 1. Conclusion: The main pharmacokinetic parameters of the two tablets showed no significant difference (P> 0.05), the relative bioavailability was (110.53 ± 34.0 7)%, AUC0 ~ t and Cmax were Bioequivalence analysis demonstrated that both formulations were bioequivalent.