尼莫地平胶囊人体生物利用度及生物等效性研究

Bioavailability and bioequivalence of nimodipine capsules

目的研究尼莫地平胶囊在健康志愿者体内的生物利用度及生物等效性。方法20例健康志愿者随机交叉口服尼莫地平胶囊和参比尼莫地平片各60 mg,采用LC-MS/MS测定血清中尼莫地平的药物浓度。结果健康志愿者口服尼莫地平胶囊试验制剂及参比制剂后的峰浓度Cmax分别为（37.459±13.224）μg.L-1和（46.223±22.980）μg.L-1,达峰时间Tmax分别为（1.150±0.384）h和（1.025±0.353）h,0~12 h药时曲线下面积AUC（0~12）分别为（94.721±27.457）μg.h-1.L-1和（95.755±32.246）μg.h-1.L-1,半衰期T1/2分别为（3.073±0.941）h和（3.026±1.139）h。结论尼莫地平胶囊和参比制剂尼莫地平片在健康志愿者体内的药动学参数相似,具有生物等效性。

Aim To evaluate the bioavailability and bioequivalence of nimodipine capsules in healthy volunteers.Methods Single oral dose of 60 mg nimodipine capsules or reference drug was given to 20 volunteers in an open randomized cross way to study the relative bioavailability.The plasma concentrations were determined by LC-MS/MS.Results The pharmacokinetic parameters of test preparation and reference preparation were as flollows：Cmax ：（37.459±13.224）μg·L-1 and（46.223±22.980）μg·L-1;Tmax：（1.150±0.384）h and（1.025±0.353）h;AUC（0~12）：（94.721±27.457）μg·h-1·L-1and（95.755±32.246）μg·h-1·L-1;T1/2：（3.073±0.941）h and（3.026±1.139）h.Conclusion Statistic analysis shows that the two preparations were bioequivalent.