酮洛芬骨架缓释片相对生物利用度研究  

Bioavailability of Ketoprofen Sustained-release Tablet

作　　者：林舒[1] 周静[2] 徐伟[1] 沙玫[1] 

机构地区：[1]福建中医学院药学系,福建福州350108 [2]四川大学华西药学院,四川成都610041

出　　处：《泉州师范学院学报》2010年第2期66-69,共4页Journal of Quanzhou Normal University

基　　金：福建省科技厅重点项目(200910011)

摘　　要：采用高效液相色谱法,以布洛芬为内标,对24 h酮洛芬骨架缓释片试验制剂以24名健康志愿者进行多剂量人体相对生物利用度试验.结果表明,试验制剂具有明显的缓释药动学特征,参比制剂的Cmax显著高于试验制剂(p<0.01),试验制剂给药后的tmax延迟,且吸收程度与作为标准参比制剂的市售缓释片相比无显著差异,人体相对生物利用度为103.76%.经统计学检验表明这两种制剂具有生物等效性,试验制剂具有峰谷浓度差异小、波动幅度小的特点,显示出缓释特征.The relative bioavailability of 24 h sustained-release tablets（Test Formulation,T. F） after oral multiple-doses in 24 healthy persons were studied by HPLC with Ibuprofen as internal standard. The results show that test formulation proves to have marked sustained-release property of pharmacokinetics. The C max of Control Formulation （C. F） is significantly higher than that of T. F （p〈0.01）. The tmax of T. F is significantly longer than that of C. F and there is no significant difference in the absorption extent. The relative bioavailability of T. F is found to be 103. 76%. The new sustained-release tablet showed less fluctuation of peak and trough in plasm drug concentrations than those of C. F at steady state and exhibited good sustained-release property.

关 键 词：酮洛芬 缓释片 药物动力学 生物利用度 

分 类 号：R969.1[医药卫生—药理学]