HPLC-MS法对两种尼莫地平制剂的生物等效性的研究

Studies on bioequivalence of two nimodipine tablets in healthy volunteers by HPLC-MS

目的评价两种国产尼莫地平片剂人体生物等效性。方法采用单剂量双交叉实验设计,用HPLC-MS法测定20名健康受试者口服两种尼莫地平片60mg后的血药浓度。结果受试制剂和参比制剂药-时曲线均符合一房室模型,t1/2分别为(2.1±0.3)和(2.2±0.4)h,tmax为(1.5±0.4)和(1.6±0.4)h,cmax为(28.21±7.12)和(28.79±7.56)ng.mL-1,AUC为(105.88±29.49)和(106.46±26.38)μg.h.L-1,受试制剂的相对生物利用度为99.4±5.3%。结论经统计学分析,两种国产片具有生物等效性。

OBJECTIVE To evaluate the bioequivalence of two domestic nimodipine tablets. METHODS A single oral administration of 60mg nimodipine tablet was given to 20 healthy volunteers. Nimodipine concentrations in plasma were determined by HPLC-MS. RESULTS The main pharmacokinetic parameters of two nimodipine tablets were as follow： t1/2 was （2.1 ± 0.3） and （2.2 ± 0.4）h, tmax was （1. 5 ± 0.4） and （1.6 ± 0.4）h, cmax was （28.21 ± 7,12） and （28.79 ± 7.56）ng·mL^-1, AUC was （105.88 ± 29.49） and （106.46 ± 26.38）μg·h·L^-1, respectively. The relative bioavailability of the test tablet was 99.4 ± 5.3 % . CONCLUSION The results demonstrated that the two tablets were bioequivalent.