摘要
目的研究富马酸美托洛尔缓释片的药物代谢动力学行为和缓释特性,并与已上市琥珀酸美托洛尔缓释片对比。方法采用随机交叉自身对照试验设计,对12只健康比格犬(雌雄各半)先后单次和多次灌胃富马酸美托洛尔缓释片(T药)和琥珀酸美托洛尔缓释片(R药)。采用LC-MS/MS法测定血药浓度;采用DAS 2.0药代动力学软件求算药代动力学参数;采用Excel软件进行统计分析。结果统计结果表明单次和多次口服给药,两种缓释片的AUC,t1/2,T max以及C max无显著性差异,生物等效.结论富马酸美托洛尔缓释片具有良好的缓释性。
Objective To investigate the pharmacokinetics and the sustained - released characteristics of Metoprolol Fumarate Sustained - release Tablets in beagle dogs. Methods Twelve beagle dogs were given single dose and multiple dose of fumarate sustained - release tablets and succinate metoprolol sustained - release tablets according to the randomized cross - cover design. The metoprolol concentration in plasma was determined by the LC - MS/MS method. The main phar- macokinetic parameters were calculated by DAS 2. 0 software and the statistical analysis was performed by the excel pro- gram. Results The statistical analysis showed that the AUC,tl/2,Tmax and C were no significantly different between the sustained - release tablets of metoprolol fumarate and succinate metoprolol. Conclusion Metoprolol Fumarate Sustained - release Tablets possessed excellent sustained release performance.
出处
《药学研究》
CAS
2014年第1期5-8,13,共5页
Journal of Pharmaceutical Research
