摘要
目的 对尼莫地平片相对生物利用度及药物动力学进行研究。方法 采用反相高效液相色谱法 (RP HPLC)测定 10名志愿受试者单剂量口服 12 0mg尼莫地平片供试品与标准参比制剂后 ,尼莫地平血药浓度的变化。用 3p87药动学程序处理实验数据 ,并对实验结果进行配对t检验和双单侧t检验。结果 药时曲线下面积分别为 82 .5 1± 2 8.73ng·ml-1·h与 82 .92± 30 .93ng·ml-1·h ,达峰时间分别为 1.75± 0 .2 6h与 1.70± 0 .2 6h ,峰浓度分别为 2 8.84± 9.0 5ng·ml-1与 2 9.0 5± 8.6 9ng·ml-1。结果表明二者AUC、峰浓度及达峰时间无显著性差异 ,尼莫地平片供试品的相对生物利用度为 10 0 .70 %± 7.4 4 %。结论 尼莫地平片供试品与标准参比制剂为生物等效制剂。
OBJECTIVE To study pharmacokinetics and relative bioavailability of Nimodipine tablets. METHODS Nimodipine was determined,after a single oral dose of two nimodipine preparations were given respectively to 10 volunteers in an open rando mized cross over test. Nimodipine concentration in plasma was assayed by RP HPLC. RESULTS After taking a single oral dose 120 mg of two nimodipine preparations, the AUC 0→∞ of nimodipine test preparations and standard preparations were 82.51±28.73 ng·ml -1 ·h and 82.92 ±30.93 ng·ml -1 ·h; T max were 1.75 ±0.26 h and 1.70± 0.26 h; C max were 28.84±9.05 ng·ml -1 and 29.05± 8.69 ng·ml -1 ,respectively.CONCLUSION The result of statistical analysis showed that there were no significant difference of the AUC 0→∞ ? T max and C max of Nimodipine tablets between the two formations.The two Nimodipine tablets were bioequivalent preparation.
出处
《华西药学杂志》
CAS
CSCD
2002年第1期32-34,共3页
West China Journal of Pharmaceutical Sciences
