头孢克洛胶囊人体药代动力学和生物等效性评价  

Evaluation on Pharmacokinetics and Bioequivalence of Cefaclor Capsules

作　　者：戴青[1] 陈勇川[1] 夏培元[1] 唐敏[1] 向荣凤[1] 熊丽蓉[1] 

机构地区：[1]中国人民解放军第三军医大学西南医院药剂科.国家药品临床研究基地,重庆400038

出　　处：《中国药业》2011年第23期6-8,共3页China Pharmaceuticals

摘　　要：目的考察国产头孢克洛胶囊与参比制剂在健康人体内的生物等效性。方法采用高效液相色谱法测定血浆中头孢克洛的质量浓度,通过对20名男性健康受试者单次交叉口服750 mg头孢克洛的受试制剂和参比制剂,计算其药物动力学参数及相对生物利用度。结果受试制剂和参比制剂的0～t药时曲线下面积(AUC0-t)分别为(29.460±5.731)和(30.106±5.349)μg/(mL.h),0～∞药时曲线下面积(AUC0～∞)分别为(30.327±6.128)和(30.909±5.497)μg/(mL.h),峰浓度(Cmax)分别为(20.901±4.070)和(21.067±3.422)μg/mL,达峰时间(tmax)分别为(0.900±0.462)和(0.800±0.208)h,半衰期(t1/2)分别为(0.660±0.082)和(0.666±0.070)h,受试制剂的相对生物利用度为(98.0±9.6)%。结论受试制剂头孢克洛胶囊与参比制剂生物等效。Objective To study the in vivo bioequivalence in healthy people between domestic Cefaclor Capsules and the reference preparation.Methods The HPLC method was established to determine the concentration of cefaclor following oral administration 750 mg of the two preparations.A single dosage crossover design was applied and 20 male healthy volunteers were included in this trial.Then the pharmacokinetic parameters and relative bioavailability were analyzed.Results The main pharmacokinetic parameters of the tested preparation and the reference preparation were as follows：AUC0-t were（29.460±5.731）,（30.106±5.349）μg/（mL·h）;AUC0-∞were（30.327±6.128）,（30.909±5.497）μg/（mL·h）;Cmax were（20.901±4.070）,（21.067±3.422）μg/mL;tmax were（0.900±0.462）,（0.800±0.208）h;t1/2 were（0.660±0.082）,（0.666±0.070）h,respectively.The relative bioavailability of the tested preparation was（98.0±9.6）%.Conclusion The tested Cefaclor Capsules is bioequivalent to the reference preparation.

关 键 词：头孢克洛 高效液相色谱法 血浆 生物等效性 

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