布洛芬混悬液及其生物等效性研究

摘要

目的：观察并研究布洛芬混悬液及其生物等效性。方法利用高效液相色谱法，对12名健康男性志愿者交叉单剂量口服布洛芬混悬液及片剂时的血药浓度进行测定，在计算出药物动力学参数及受试制剂的生物利用度的基础上，对两种制剂的生物等效性进行同时评价。结果布洛芬混悬液与片剂的吸收速率、达峰时间、峰浓度差异具有统计学意义（P<0.05），表明布洛芬混悬液的吸收速度更快，而消除半衰期及药-时曲线下面积差异不显著（P>0.05）。结论布洛芬混悬液与布洛芬片剂具有生物等效性。%ObjectiveTo observe and study Ibuprofen Suspension and its bioequivalence.Methods Using high performance liquid chromatography, the drug concentration in blood of 12 healthy male volunteers a single dose of oral Ibuprofen Suspension and tablets were determined, in the calculation of test preparation and bioavailability based on pharmacokinetic parameters, at the same time to evaluate the bioequivalence of two preparations.Results The absorption rate, Ibuprofen Suspension tablets and statisticaly significant differences in peak time, peak concentration (P<0.05), show that Ibuprofen Suspension absorption speed is faster, and the elimination half-life and drug - area under curve did not show significant difference (P>0.05). ConclusionIbuprofen Suspension with ibuprofen tablets are bioequivalent.