【摘要】 目的 :研究尼莫地平在健康人体内的药动学和相对生物利用度。方法 :8名健康受试者单剂量随机交叉口服尼莫地平标准参比制剂和待测制剂 1 2 0mg,采用HPLC法测定用药后不同时间的血药浓度。结果 :2种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (1 4 3.1± 9.9) μg·h·L-1 和 (1 37.0± 7.3) μg·h·L-1 ,Cmax分别为 (83.1±7.4 ) μg·L-1 和 (80 .8± 4 .6 ) μg·L-1 ,Tmax分别为 (1 .0 0± 0 .0 0 )h和 (1 .0 6± 0 .1 7)h。待测制剂的相对生物利用度为 (96 .0± 5 .9) %。经双向单侧t检验证明 ,2种制剂的AUC、Cmax相比 ,差异均无统计学意义。结论 :2种制剂具有生物等效性。更多还原

【Abstract】 Aim: To study the pharmacokinetics and relative bioavailability of nimodipine in healthy volunteers. Methods:The plasma concentrations of nimodipine were determined by HPLC in 8 healthy male volunteers after an oral dose of 120 mg standard or tested formulation in crossways. Results:The concentration-time curves of the two formulations were both fitted to the one-compartment open model. The AUC were (143.1±9.9)μg·h·L -1 and(137.0±7.3) μg·h·L -1 ,the C max values were(83.1±7.4) μg·L -1 and (80.8±4.6) μg·L -1 ,the T max values were(1.00±0.00)h and (1.06±0.17)h,respectively.The relative bioavailability of the tested formulation was(96.0±5.9)%. Conclusion:It is suggested that the two formulations are bioequivalent.更多还原