布洛芬缓释片人体生物等效性研究

Human Bioequivalence of Ibuprofen Sustained Release Tablet

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。

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） according 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 bioavailability（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.