【摘要】 目的研究头孢克肟口崩片与胶囊在中国健康成年男性志愿者体内的相对生物利用度,评价两者的生物等效性。方法采用随机、开放、双周期交叉试验设计,20名男性健康受试者分别单剂量口服试验制剂头孢克肟口崩片200 mg或参比制剂胶囊200 mg。采用HPLC-UV法测定给药后不同时间采集的血样中头孢克肟的血药浓度。结果受试者单次口服200 mg头孢克肟后,头孢克肟口崩片与胶囊的Cmax分别为(2.922±1.161)、(2.725±1.042)mg.L-1;tmax分别为(3.42±0.94)、(3.50±0.61)h;AUC0~t分别为(21.32±9.87)、(19.54±9.51)mg.h.L-1;t1/2分别为(3.68±1.69)、(3.86±1.73)h。方差分析结果表明2种制剂的参数之间没有显著性差异,头孢克肟口崩片与胶囊的相对生物利用度为(110.2%±12.7%)。结论受试制剂头孢克肟口崩片与参比制剂头孢克肟胶囊为生物等效制剂。更多还原

【Abstract】 Objective To determine the relative bioavailability of cefixime orally disintegrating tablets and capsules and to evaluate their bioequivalence.Methods According to the crossover design,each volunteer was given a single oral dose of 200 mg cefixime orally disintegrating tablets or capsules.The plasma was obtained and determined by HPLC-UV.Results The pharmacokinetic parameters of cefixime orally disintegrating tablets and capsules in the plasma were as follows:Cmax was(2.922±1.161)and(2.725±1.042)mg·L-1;tmax was(3.42±0.94)and(3.50±0.61)h;AUC0~t was(21.32±9.87)and(19.54±9.51)mg·h·L-1;t1/2 was(3.68±1.69)and(3.86±1.73)h.The relative bioavailability of the two preparations was(110.2%±12.7 %).Conclusion The two cefixime preparations were bioequivalent.更多还原