国产阿莫西林／克拉维酸片人体生物等效性研究

目的以进口阿莫西林/克拉维酸片为对照，考察国产制剂的人体生物等效性。方法10名健康受试者随机交叉单剂量口服2种制剂（阿莫西林250mg，克拉维酸钾125mg）后，采用微生物法测定血浆中药物浓度。结果血药浓度数据经3P97拟合，两者的体内过程皆符合血管外口服给药一室模型,采用梯形法计算的阿莫西林AUC0～t分别为（12.89±1.03）和（13.54±0.59）（mg

Bioequivalence ofamoxicillin and clavulanic acid tabletsin healthy volunteers

Objective:To study the relative bioequivalence of domest ic and imported amoxicillin and clavulanic acid tablets.Methods:The ra ndomized and crossover study was conducted in 10 healthy male volunteers.After a single dose of the drugs their plasma drug concentration was determined by micr obiological assay.Results:Both the domestic and imported tablets of am oxicillin and clavulanic acid fitted to one compartment model.The pharmacokineti cs parameters obtained were:Cmax=(5.17±0.45)mg/L,Tmax=(1.05±0. 16)h,t1/2=(1.16±0.17)h,AUC0～t=(12.89±1.03)(mg*h)/L for domestic amoxicillin;Cmax=(5.25±0.46)mg/L,Tmax=(1.08±0.23)h,t1/2=(1.3 7±0.23)h,AUC0～t=(13.54±0.59)(mg*h)/L for imported amoxicillin;Cmax =(3.94±0.52)mg/L,Tmax=(1.10±0.21)h,t1/2=(0.98±0.11)h,AUC 0～t=(8.25±0.92)(mg*h)/L for domestic clavulanic acid;Cmax=(4.10±0. 35)mg/L,Tmax=(1.03±0.10)h,t1/2=(1.01±0.14)h,AUC0～t=(8.18± 0.51)(mg*h)/L for imported clavulanic acid.The relative bioequivalence was: (95.3±7.3)% for amoxicillin;(100.6±6.0)% for clavulanic acid.Conclusion:The domestic and imported amoxicillin and clavulanic acid tablets are bioequ ivalence.