文档介绍：头孢克肟胶囊在健康人体内的相对生物等效性
作者:赵磊,文爱东,张三奇,同丽萍,吴寅
【关键词】头孢克肟
【Abstract】 AIM: pare the ic parameters and relative bioavailability of domestic and imported Cefixime capsules in healthy volunteers and to study the quality of the medicine. METHODS: A single oral dose of 200mg domestic and imported Cefixime capsules was given to 12 healthy volunteers in a randomized twoperiod crossover study. The concentrations of Cefixime in serum were determined by HPLC method. The main ics parameters (AUC, ρmax and Tmax) were analyzed by two simultaneous onesided t test. RESULTS: The concentration time curves of domestic and imported Cefixime capsules conformed to the partment open model with firstorder absorption. The AUC (0~24 h), ρmax and Tmax of domestic and imported Cefixime capsules were (± )and ( ±)mg・h-1・L-1,(±)and(±)mg・L-1, and (±)and(±)h respectively. The relative bioavailability of domestic Cefixime capsules was %. CONCLUSION: Both domestic and imported Cefixime capsules are of the same bioequivalence in healthy volunteers.
【Keywords】 cefixime; ics; bioequivalence; HPLC
【摘要】目的: 比较国产和进口头孢克肟胶囊在健康人体内的药代动力学及相对生物等效性,确保临床用药质量. 方法: 采用标准二阶段交叉设计自身对照试验法,12名男性健康志愿受试者分别口服单剂量两种头孢克肟胶囊,用RPHPLC法测定血清中头孢克肟的浓度,以双向单侧检验统计法比较2种头孢克肟胶囊之间的差异. 结果: 国产和进口头孢克肟胶囊在健康志愿者体内的药时曲线均符合血管外给药一室开放模型,其主要的药代动力学参数Tmax分别为(±)和(±)h,ρmax、