两种尼莫地平片剂的人体生物等效性

Study on Bioequivalence of Two Nimodipine Tablets

目的:研究国产和进口尼莫地平片剂的人体生物等效性.方法:选择20名健康志愿者,随机交叉口服单剂量60mg国产和德国产尼莫地平片后,采用高效液相色谱法测定血浆中的血药浓度。结果:口服尼莫地平片剂后国产及德国产片剂达峰时间t_(max)分别为52.65min及51.36min;C_(max)分别为26.61mg·L^(-1)和29.05mg·L^(-1);AUC_(0-∞)为4170.76及4291.36mg·min·L^(-1),二种片剂主要药代动力学参数比较无显著性差异(P>0.05).结论:国产尼莫地平片与进口尼莫地平片相对生物利用度均为97%,经统计学处理证实二种片剂具有生物等效性。

Objective： To study the bioequivalent of the domestic and imported nimodipine tablet in healthy volunteers. Methods： A single oral 60mg of tablets nimodipine（Germany） or domestic nimodipine was given to 20 healthy male volunteers in a randomized crossover study. Plasma concentrations were determined with high performance liquid chromatography method. Results： It was found that main pharmacokinetic parameters of domestic nimodipine tablet were tmax ： 52.65 ± 17.08min, Cmax ： 26.61±19.59μg·L^-1, t1/2K ： 84.04 ± 52.68min, AUC0～∞ ：4170.76 ± 2296.71μg ·min·L^-1 respectively. Conclusion： Relative bioavailability of domestic nimodipine tablet was 97% ± 7% compared with nimodipine （Germany） tablet, The pharmacokinetic parametecs between two tablets had no significant difference （P〉0. 05） .The two formulations were of bioequivalence.