头孢呋辛酯片健康人体生物等效性评价  

Bioequivalence of Cefuroxime Axetil Tablets in Healthy Volunteers

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]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》2010年第23期8-9,共2页China Pharmaceuticals

摘　　要：目的考察国产头孢呋辛酯片与参比制剂(西力欣片)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呋辛的质量浓度。通过对20名男性健康受试者单次交叉口服500mg头孢呋辛酯的受试制剂和参比制剂,计算其药代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(20.206±4.571)μg(/mL·h)和(20.098±4.849)μg(/mL·h),峰浓度(Cmax)分别为(5.764±1.164)μg/mL和(5.757±1.331)μg/mL,达峰时间(Tmax)分别为(2.225±0.573)h和(2.100±0.598)h,血浆半衰期(t1/2)分别为(1.319±0.166)h和(1.376±0.184)h,受试制剂的相对生物利用度为106.2%。结论受试制剂头孢呋辛酯片与参比制剂生物等效。Objective To study the in vivo bioequivalence in healthy people betwe en domestic Cefuroxime Axetil Tablets and the reference ones（Zinacef Tablets）.M ethods The HPLC method was established to determine the concentration of cefurox ime following oral administration 500 mg of the two preparations.A single dosage crossover design was applied and 20 male healthy volunteers were included in th is trial.Then the pharmacokinetic parameters and relative bioavailability were a nalyzed.Results The main pharmacokinetic parameters of tested preparation and re ference preparation were as follows：AUC0-t was （20.206±4.571）μg/（mL·h） and（20.098±4.849）μg/（mL·h）;Cmax was （5.764±1.164）μg/mL and （5.757±1.331）μg/mL ;Tmax was（2.225±0.573）h and （2.100±0.598）h;t1/2 was （1.319±0.166）h and （1.37 6±0.184）h respectively.The relative bioavailability of tested preparation was 1 06.2%.Conclusion Tested Cefuroxime Axetil Tablets is bioequivalent to reference preparation.

关 键 词：头孢呋辛酯 头孢呋辛 高效液相色谱法 血浆 

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