醋氯芬酸胶囊人体药代动力学及生物等效性研究

Study of the Pharmacokinetics and Bioequivalance of Aceclofenac Capsules and Beofenac in Healthy Volunteers

目的 :研究国产醋氯芬酸胶囊在人体内的药代动力学参数和生物等效性。方法 :18名健康男性志愿者随机交叉口服国产醋氯芬酸胶囊100mg 和进口Beofenac片100mg,采用HPLC法测定给药后不同时间点血浆醋氯芬酸的浓度 ,用3p97程序拟合房室模型并计算其药代动力学参数 ,评价两种制剂的生物等效性。结果与结论 :两种制剂的血药浓度曲线均符合二室模型 ,主要药代动力学参数均无显著性差异 (P>0 05) ;经双单侧t检验 ,国产醋氯芬酸胶囊与进口Beofenac片具有生物等效性。

OBJECTIVE:To study the pharmacokinetics profiles and bioequivalence of Aceclofenac capsules in healthy volunteers METHODS:A single oral dose of 100mg Aceclofenac and the same dose of Beofenac were given to 18 healthy volunteers in an open randomized crossover study Aceclofenac concentrations in plasma were determined by HPLC method RESU_LTS:The concentration-time curves of Aceclofenac and Beofenac were conformed to a twocompartment model The relative bioavailability of Aceclofenac capsule was(96 27±12 97%)% There were no significant differences between the pharmacokinetic parameters of two preparations(P>0 05) CONCLUSION:The results of the statistical analysis showed that the two formulations were bioequivalent