统计矩法回顾性分析布洛芬不同剂型的体内释放特征  

Retrospective study of in vivo dissolution/release kinetics of different dosage forms of ibuprofen by moment theory

作　　者：裴小兵[1] 吴增宝 

机构地区：[1]安徽医科大学校医院,安徽合肥230032 [2]上海玉安药业有限公司,上海200137

出　　处：《安徽医药》2005年第2期93-96,共4页Anhui Medical and Pharmaceutical Journal

摘　　要：目的　分析布洛芬不同剂型的体内释放特征 ,揭示血管外给药制剂的体内溶出特征及其意义。方法　以非房室模型的统计矩法 ,对文献报道的布洛芬不同剂型 (口服液、颗粒剂、片剂、缓释胶囊等 )在中国人中的血药浓度特征进行回顾性分析 ,比较各剂型的体内释放特征。结果　以布洛芬口服液为标准速释制剂 ,布洛芬混悬剂的体内平均溶出时间 (MDT)约为 0 0 6 5～0 15 1h ,体内溶出较快 ;片剂的MDT约 0 14 6～ 1 2 5 5h ,差异较大 ,各产品内在质量不一 ;缓释胶囊的MDT约 3 4 92h。结论　同一活性成分的不同固体制剂的体内释放特征差异较大 ,应加强此类药物的体内释放动力学研究 ,以保证药物制剂的内在质量。Aim Analyze the in vivo release characteristics of different dosage forms of ibuprofen so as to illustrate the property of the in vivo release of nonparenteral administration. Methods The reported plasma profiles in healthy Chinese volunteers of different nonparenteral dosage forms of ibuprofen, namely, oral solution, suspensions, tablets and sustained release capsules, were retrospectively processed by moment theory method to elucidate the respective in vivo release kinetics. Results Compared to the oral solution, the mean dissolution time (MDT) of the suspensions, tablets and sustained release capsules were respectively about 0.065～0.151 h, 0.146～1.255 h and 3.492 h. The in vivo dissolution kinetics of the ibuprofen tablets varied obviously by different manufacturers. Conclusion It was concluded that the different dosage forms of the same active ingredient might show different in vivo release characteristics, attention should be paid to the in vivo release kinetics of the hydrophobic drugs to ensure a solid pharmacokinetic anticipation.

关 键 词：统计矩法 回顾性分析 布洛芬 剂型 体内释放特征 同有溶出度 

分 类 号：R94[医药卫生—药剂学]