阿莫西林克拉维酸钾复合制剂生物等效性研究  

Bioequivalence of Amoxicillin and Clavulante Potassium Dispersible Tablet in Healthy Volunteers

作　　者：傅军[1] 张红[1] 陈晓媛[1] 熊玉卿[1] 

机构地区：[1]江西医学院临床药理研究所,江西南昌330006

出　　处：《解放军药学学报》2002年第5期277-279,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　进行国产阿莫西林克拉维酸钾分散片生物等效性研究。方法　 18名健康男性志愿者交叉口服受试和参比制剂 6 2 5mg(其中阿莫西林 5 0 0mg ,克拉维酸钾 12 5mg) ,采用微生物学方法测定血浆中药物浓度。结果　受试及参比制剂的主要药动学参数分别为 :阿莫西林 Tmax　分别为 1.0 5 6± 0 .2 73、1.2 4 1± 0 .396h ,C max　分别为 5 .36 9± 1.12 4、5 .2 13± 0 .90 3μg·ml-1,AUC0 -6分别为 10 .36 9± 1.776、10 .36 2± 1.370 μg·h·ml-1,T1/2ke　　分别为 1.0 83± 0 .16 6、1.10 1± 0 .2 12h。克拉维酸钾Tmax　分别为1.0 84± 0 .2 92、1.2 87± 0 .2 84h ,Cmax　分别为 2 .796± 0 .878、2 .74 2± 0 .892 μg·ml-1,AUC0 -6分别为 6 .6 18± 2 .15 9、6 .793± 2 .2 74 μg·h·ml-1,T1/2ke　　分别为 1.2 0 7± 0 .16 5、1.2 6 1± 0 .2 0 1h。Aim To study the bioaequivalemv of amoxicillin and clavulante potassium dispersible tablet.Methods In randomized crossover design,single doses of compound amoxicillin tested tablet or reference tablet 625mg (amoxicillin 500mg,clavulante potassium 125mg) were given to 18 healthy male volunteers.Plasma concentration was measured by bioassay.Results The pharmacokinetic parameters of tested and reference products were calculated as the follows: amoxicillin T max 1.056±0.273 and 1.241±0.396h,C max 5.369±1.124 and 5.213±0.903μg·ml -1 ,AUC 0-6 10.369±1.776 and 10.362±1.370μg·h·ml -1 ,T 1/2ke 1.083±0.166 and 1.101±0.212h,clavulante potassium T max 1.084±0.292 and 1.287±0.284h,C max 2.796±0.878 and 2.742±0.892μg·ml -1 ,AUC 0-6 6.618±2.159 and 6.793±2.274μg·h·ml -1 ,T 1/2ke 1.207±0.165 and 1.261±0.201h,respectively.Conclusion The results demonstrated that two formulation of amoxicillin and clavulante potassium are bioequivalent by statistic analysis results.

关 键 词：阿莫西林克拉维酸钾复合制剂 生物等效性 研究 药代动力学 

分 类 号：R978.11[医药卫生—药品] R969.1[医药卫生—药学]