国产尼莫地平分散片的药代动力学和生物利用度

The pharmacokinetics and bioavailability of domestic nimodipine dispersible tablets

目的 :以进口尼莫通片为对照 ,考察国产尼莫地平分散片的药代动力学和相对生物利用度。方法 :10名男性健康志愿受试者 ,随机交叉单剂量口服 2种片剂各 12 0mg ,采用HPLC法测定血药浓度。 结果 :经 3P87程序处理 ,国产尼莫地平分散片的Tmax为 (0 .73± 0 .0 6 )h ,Cmax为 (6 8.99± 8.5 4) μg/L ,t1/2 为 (1.31± 0 .46 )h ,AUC0～t为 (15 2 .76± 2 0 .2 0 ) (μg·h) /L ,相对生物利用度为 (97.2 5± 2 .36 ) %。 结论

Objective:To study the pharmacokinetics and relative bioavailability of domestic nimodipine dispersible tablets.Methods:The randomized,crossover study was conducted in 10 healthy volunteers.After receiving a single 120mg of domestic or imported nimodipine tablet blood drug concentration was determined by HPLC.Results:The pharmacokinetic parameters obtained were:T max = (0.73± 0.06)h,C max =(68.99±8.54)μg/L,t 1/2 =(1.31±0.46)h,AUC 0～t =(152.76±20.20) (μg·h)/L. The relative bioavailability obtained was (97.25±2.36)% in comparison with imported drug.Conclusion:Results obtained showed that domestic and imported nimodipine dispersible tablets are bioequivalent.