国产尼莫地平胶囊和片剂生物等效性评价

目的 评价尼莫地平胶囊和片剂的生物等效性。方法 18 名健康男性志愿者随机交叉口服单剂量100mg 国产尼莫地平胶囊或片剂,2wk 后进行第2次试验,交叉服用同剂量的对照品或供试品,用高效液相色谱法测定血浆药物浓度。结果 血药浓度-时间曲线拟合表明,该药物符合体内一级吸收的一室开放模型。其C_max为(56.4±16.9)μg·L^-1,t_1/2ke为(2.08±0.42)h,t_peak为(1.27±0.52)h,AUC_0~9为(197.2±46.5)μg·h·L_-1,与对照品的主要药代动力学参数比较,经方差分析和双单侧t检验,无显著性差异(P>0.05)。供试品相对于对照品的生物利用度为(99.3±13.1)%。结论 两制剂体内过程相仿,具有生物等效性。

Bioequivalence of domestic nimodipine capsules and toblets

Aim The bioequivalence of domestic nimodipine capsules and tablets in healthy volunteers was compared.Methods A single oral dose of capsule or tablet of 100 mg nimodipine was given to 18 healthy volunteers in a randomized crossover study.Plasma levels of the drue were determined with HPLC method.Results The plasma concentration-time curve fitted to the first order absorption,1-compartment open model.Their main pharmacoknietic parameters were C_max (56.4±16.9)μg·L^-1,t_1/2(ke) (2.08±0.42)h,t_peak (1.27±0.52) h ,AUC_0~9 (197.2±46.5)μg ·h^-1·L^-1.These was no statistically significant difference between the two products (P>0.05).The relative bioavailability of tested capsules to reference tablets was (99.3±13.1)%.Conclusion Both formulations are of bioequivalence.