摘要
目的研究尼莫地平2种晶型在家兔体内药动学和生物等效性。方法家兔单剂量交叉口服尼莫地平不同晶型胶囊, 采用HPLC测定血药浓度,非隔室模型计算药动学参数,利用方差分析、单-双侧t检验和(1-2α)置信区间评价其生物等效性。结果尼莫地平晶型Ⅰ和Ⅱ的Cmax分别为46.7和39.6 ng·mL-1,tmax为2.8和3.0 h,AUC0→t为351.5和341.0 ng·h·mL-1。尼莫地平晶型Ⅱ相对于晶型Ⅰ的生物利用度为97.0%。结论尼莫地平2种晶型具有生物等效性。
OBJECTIVE: To study pharmacokinetics and relative bioavailability of nimodipine polymorphs in rabbits. METHODS: According to the crossover design, each rabbit was orally given nimodipine polymorph capsules. The plasma concentrations were determined by HPLC. Pharmacokinetic parameters were calculated. The analysis of variance and two-one sided t test were used as statistical analysis. RESULTS: After a single oral dose, cmax were 46.70 and 39.64 ng·mL-1, tmax were 2.8 and 3.0 h, AUC0&rarrt were 351.5 and 341.0 ng·h·mL-1 for nimodipine I and II, respectively. The relative bioavailability of nimodipine polymorph II was 97.0% compared with I. CONCLUSION: Nimodipine polymorphe were bioequivalent.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2005年第8期609-612,共4页
Chinese Pharmaceutical Journal
