布洛芬颗粒的人体药动学及生物等效性研究

目的：研究单剂量口服布洛芬颗粒的药动学特征，并评价两种制剂的生物等效性。方法：采用双周期交叉试验，18名健康志愿者分别单剂量口服受试试剂或参比制剂布洛芬颗粒600mg，用HPLC法测定血药浓度，计算药动学参数，并进行统计分析。结果：布洛芬颗粒受试制剂和参比制剂的主要药动学参数分别为tmax（2．56±0．51）和（2．56±0．51）h，fmax（42．81±8．00）和（42．76±7．84）μg／mL，t1／2（1．79±0．17）和（1．75±0．21）h，AUC0～15（105．10±12．90）和（105．67±10．32）μg·h·mL^-1，AUC0-∞（105．99±12．94）和（106．60±10．33）μg·h·mL^-1。结论：受试制剂的相对生物利用度为（99．29±4．66）％，两种制剂具有生物等效性。

Pharmacokinetics and bioequivalence of ibuprofen granules

Objective: To study the pharmacokinetics of ibuprofen granules and evaluate the bioequivalence of test and reference formulations.Methods:Eighteen healthy volunteers were given a single oral dose of 600 mg ibuprofen granules of test and reference formulations respectively in a two-period cross-over test.Plasma concentration of ibuprofen was determined by HPLC method.Pharmacokinetic parameters of the two formulations were calculated and statistically analyzed.Results:The main pharmacokinetic parameters of test and reference formulations of ibuprofen granules were as follows,t_(max) (2.56±0.51) and (2.56±0.51) h,c_(max) (42.81±8.00) and (42.76±7.84) μg/mL,t_(1/2) (1.79±0.17) and (1.75±0.21) h,AUC_(0-15) (105.10±12.90) and (105.67±10.32) bioavailability of the test formulation is (99.29±4.66)%.The two preparations are bioequivalent.