2种头孢克罗胶囊的人体药代动力学及相对生物利用度研究  

Studies on Pharmacokinetics and Relative Bioavailability of Two Kinds of Cefaclor Capsule in Healthy Volunteers

作　　者：董淳 鲁义东[2] 

机构地区：[1]深圳市人民医院,暨南大学附属第二医院药学部,深圳市518020 [2]安徽医科大学附属医院临床药理室,合肥市241000

出　　处：《中国药房》2001年第8期482-483,共2页China Pharmacy

摘　　要：目的 :研究2种头孢克罗胶囊在健康人体内的药代动力学与相对生物利用度。方法 :采用HPLC法测定人体血浆药物浓度 ,所有受试者随机交叉单剂量口服500mg 国产或进口头孢克罗胶囊。结果 :2种药品的药 -时曲线符合一室开放模型 ,国产和进口头孢克罗胶囊的峰浓度Cmax 为(13 24±2 42)和(13 29±3 14)μg/m1 ;达峰时间Tmax 为(0 58±0 192)和(0 55±0 10)h ;消除半衰期T1/2 为(0 42±0 09)和(0 41±0 09)h ,药 -时曲线下面积AUC0～T 为(15 81±1 53)和(15 68±1 97)h/(μg m1)。结论 :国产与进口头孢克罗胶囊具有生物等效性 ,国产胶囊的相对生物利用度为(100 84±7 78) %。OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of cefaclor capsule in healthy volunteersMETHODS:Plasma cefaclor concentrations were measured with HPLC methodEach subject was administered with a single oral dose of domestic or imported cefaclor capsule(500mg)in a randomized crossover studyRESULTS:Plasma concentration-time curves of domestic and imported cefaclor capsules fitted to a one-compartment open model with a first order absorptionThe peak plasma levels(Cmax)averaged(1324±242)and (1329±314)μg/ml,times to reach the peak level(Tmax)were (058±0192)and(055±010)h,the elimination half lives(T1/2)were (042±009)and(041±009)h,the areas under the plasma concentration-time curve(AUC0～T)were (1581±153)and(1568±197)h/(μg·ml)respectivelyCONCLUSION:The results of statistical analysis showed that the two formulations were bioequivalentThe relative bioavailability of domestic capsule was(10084±778)%

关 键 词：头孢克罗 胶囊 药代动力学 生物利用度 生物等效性 

分 类 号：R978.11[医药卫生—药品]