国产尼莫地平胶囊和片剂生物等效性评价  

Bioequivalence of domestic nimodipine capsules and toblets

作　　者：张红[1] 傅军[1] 戴群[1] 李艳艳[1] 熊玉卿[1] 

机构地区：[1]江西医学院临床药理研究所,南昌330006

出　　处：《中国临床药理学与治疗学》2000年第3期245-247,共3页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：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Cmax 为 (56.4±16.9) μg·L -1 ,t1/2ke为 (2.08±0.42)h ,tpeak 为(1.27±0.52)h ,AUC0～9 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。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 Cmax (56.4±16.9) μg·L-1, t1/2(ke)(2.08±0.42) h, tpeak(1.27±0.52) h,AUC0～9 (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.

关 键 词：尼莫地平 高效液相色谱 生物等效性 胶囊片剂 

分 类 号：R972[医药卫生—药品] R969.1[医药卫生—药学]