头孢呋辛酯颗粒剂人体生物等效性研究  

A Study on Bioequivalence of Cefuroxime Axetil Granules in Healthy Volunteers

作　　者：张军[1] 周学敏[1] 赵娜[2] 蔡文科[2] 

机构地区：[1]南京医科大学药学院,江苏南京210029 [2]锦州医学院药学系,辽宁锦州121001

出　　处：《药学进展》2006年第11期502-504,共3页Progress in Pharmaceutical Sciences

摘　　要：目的:考察头孢呋辛酯颗粒剂及其片剂西力欣的人体生物等效性和药动学。方法:以头孢呋辛酯颗粒剂作受试制剂,西力欣片剂作参比制剂,20名健康男性志愿者交叉单剂量口服500 mg两种制剂。采用HPLC-UV法测定头孢呋辛血药浓度,色谱柱:Discovery C18(4.6 mm×150 mm,5μm),流动相:0.05 mol/L醋酸钠缓冲液(pH=3.9)-乙腈(89 11),流速:1.0 mL/min,检测波长:273 nm,进样量:50μL。应用BAPP2.0数据处理程序进行药动学及相对生物利用度分析。结果:受试制剂和参比制剂的Cmax分别为(5.75±1.54)和(5.73±1.62)mg/L,tmax分别为(1.5±0.3)和(1.5±0.2)h,t1/2分别为(1.67±0.28)和(1.67±0.26)h,AUC0-10h分别为(17.55±4.57)和(17.24±3.84)mg.h/L。受试制剂的相对生物利用度为(103.8±24.0)%。结论:头孢呋辛酯颗粒剂和西力欣片剂生物等效。Objective： To investigate the bioequivalenee of eefuroxime axetil granules to its tablets Zinaeef and its pharmacokinetics. Methods： A single oral administration of 500 mg cefuroxime axetil granules as test drug and Zinaeef as reference drug were erossedly given to 20 healthy male volunteers. HPLC-UV method was developed to determine the concentration of eefuroxime axetil in human plasma. The pharmaeokineties and relative bioavailability were analyzed applying BAPP2.0 data processing program. Results： The main phannaeokinetic parameters of test drug and reference drug were as follows： Cmax were （5.75 ± 1.54） and （5.73 ± 1. 62） mg/L, tmax were （1.5 ± 0.3） and （1.5 ± 0.2） h, t1/2 were （1.67 ± 0.28） and （1.67 ± 0.26） h, AUC0-10h were （ 17.55 ± 4.57） and （ 17.24 ± 3.84） mg·h/L, respectively. The relative bioavailability of test drug was （103.8 ± 24.0）%. Conclusion： Cefuroxime axetil granules were bioequivalent to its tablets Zinaeef.

关 键 词：头孢呋辛酯 颗粒剂 高效液相色谱 生物等效性 

分 类 号：R96[医药卫生—药理学]