【摘要】 目的 :比较研究布洛芬混悬液和市售布洛芬片的生物利用度和药代动力学。方法 :选择20名健康男性志愿者 ,随机分为两组 ,进行单次混悬液或片剂交叉给药600mg后 ,利用HPLC法测定血浆中布洛芬浓度。结果 :两组血浆的布洛芬浓度分别在(1 12±0 23)和 (1 76±0 48)小时达到峰值 (14 46±1 85)和 (13 56±2 98)μg/ml。血药浓度曲线下面积 (AUC)分别达 (46 76±3 65)和 (44 13±5 01)μg/ml ,混悬液的相对生物利用度 (F)为 (104 3±10 7) %。结论 :布洛芬混悬液和市售布洛芬片两种制剂具有生物等效性。更多还原

【Abstract】 Objective:The pharmacokinetics and relative bioavaibability of a suspension formulation of ibuprofen and commercial ibuprofen tablets were comarped after a single oral dose of ibuprofen in normal volunteers.Methods:Twenty healthy male volunteers were selected and divided randomly into 2 groups.Following a single oral dose(600 mg) of suspension or tablets administered alternatively,a HPLC assay was developed to measure plasma concentrations of ibuprofen.Results:After a single oral dose(600mg)the peak levels of ibuprofen in plasma averaged(14.46±1.85) and (13.56±2.98)μg/ml at(1.12±0.23)h and (1.76±0.48)h and the area under curve(AUC) were(46.76±3.65) and (44.13±5.01) μg/(min.ml) for suspension and commercial tablet formulations respectively.The relative bioavailability of suspension formulation was (104.3±10.7)%.Conclusion:The results of two one sided tests showed that these two formulations were bioequivalent.更多还原