CAJ | 학술논문

目的：研究布洛芬缓释片的人体生物等效性。方法2012年11月至2013年8月，选择20例男性志愿者，按随机数字表法随机分成观察组和对照组，各10例。观察组服用布洛芬缓释片，对照组服用布洛芬缓释胶囊（芬必得）。采用高效液相色谱( HPLC )法测定血药浓度，经3p97型药代动力学方案拟合并对比药代动力学参数。结果与对照组相比，观察组在峰浓度（ Cmax）、0~24 h药时曲线下面积（ AUC0－24）以及 AUC0－∞等水平差异均显著（ P﹤0.05）。观察组峰浓度变化较平缓，且药物缓释效果较好，相对生物利用度（ F值）为103.7%。结论与参比制剂相比，布洛芬缓释片可更好地发挥缓释效果，临床应用前景广阔，值得深入研究。
목적：연구포락분완석편적인체생물등효성。방법2012년11월지2013년8월，선택20례남성지원자，안수궤수자표법수궤분성관찰조화대조조，각10례。관찰조복용포락분완석편，대조조복용포락분완석효낭（분필득）。채용고효액상색보( HPLC )법측정혈약농도，경3p97형약대동역학방안의합병대비약대동역학삼수。결과여대조조상비，관찰조재봉농도（ Cmax）、0~24 h약시곡선하면적（ AUC0－24）이급 AUC0－∞등수평차이균현저（ P﹤0.05）。관찰조봉농도변화교평완，차약물완석효과교호，상대생물이용도（ F치）위103.7%。결론여삼비제제상비，포락분완석편가경호지발휘완석효과，림상응용전경엄활，치득심입연구。
Objective To study the human bioequivalence of Ibuprofen Sustained Release Tablet. Methods 20 cases of male volunteers were selected from March 2012 to March 2013 and divided into the observation group(10 cases)and the control group(10 cases)ac-cording to the random digital table. The observation group took oral Ibuprofen Sustained Release Tablet,while the control group took oral Ibuprofen Sustained Release Capsule(fenbid). The blood drug concentration was determined by HPLC,which was fitted by the 3p97 pharmacokinetic program and compared with the pharmacokinetic parameters. Results Compared with the control group,the observation group had significant differences in Cmax,AUC0 -24 and AUC0 -∞ levels,all showing the statistical significance( P ﹤ 0. 05). The peak concentration change in the observation group was more gentle and the effect of drug sustained release was better,the relative bioavail-ability(F value)was 103. 7%. Conclusion Compared with the reference preparation,Ibuprofen Sustained Release Tablet can better play the sustained release effect with the broad application prospects in clinic,which is worthy of further research.