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3.0h,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。
Abstract
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 3.0h, AUC0→t were 351.5 and 341.0 ng·h·mL-1 for nimodipine Ⅰ and Ⅱ.respectively. The relative bioavailability of nimodipine polymorphⅡ was 97.0% compared with Ⅰ . CONCLUSION Nimodipine polymorphs were bioequivalent.
关键词
尼莫地平 /
多晶型 /
药动学 /
生物利用度 /
高效液相色谱法
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Key words
nimodipine /
polymorph /
pharmacokinetics /
bioavailability /
HPLC
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袁恒杰;陈大为;刘艳丽;范立君.
尼莫地平多晶型家免体内药动学研究[J]. 中国药学杂志, 2005, 39(08): 609-611
YUN Heng-jie;CHEN D-wei;LIU Yn-li;FN Li-jun.
Study on pharmacokinetics of nimodipine polymorphs in rabbits[J]. Chinese Pharmaceutical Journal, 2005, 39(08): 609-611
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参考文献
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脚注
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