头孢呋辛酯片在健康志愿者的生物等效性研究.pdf

第十一届江苏省药师周大会论文粜头孢呋辛酯片在健康志愿者的生物等效性研究张宏文1,欧宁1,王源园1,刘强晖2,王蔚青1,孟玲1 南京医科大学第一附属医院。药剂科,2急诊医学科,南京210029 摘要目的:研究头孢呋辛酯片在健康受试者体内的药动学特征。方法:20名健康男性志愿者采用2制荆双周期交叉试验设计。以头孢噻肟钠为内标,采用LC—MS法测定血中药物浓度。,评价两种制荆的生物等效性。结果:20名受试者口服250rag受试制剂和参比制荆后头孢呋辛酯的主要药代动力学参数c。。分别为(-')·L。和(±)“g·L~;t一分别为(-0. 8)h和(±)h;￡l/2分另q为(±)h和()h;MRT为()h和(±)h; (±)斗g·h·L一1和(±)斗g·h·L‘1;AUCo.,为(±3642. 14)Ixg·h·L。1和(±)p,g·h·L~。主要药动学参数经统计学分析,无明显差异。两种制剂的相对生物利用度为( 4-)%。结论:两种制荆具有生物等效性。关键词头孢呋辛酯;生物等效性;LC—MS;生物利用度;血药浓度;药动学 BiOequiValenCe ofCefuroxime Tablet inHealthy Volunteers ZHONG Hong—wenl,OU Nin91,WANG Yuan—yuanl, LIUQiang—hui2,WANG Wei—qin91,MENG Lin91 Department矿鼢讲m叫,2Emergengy department,the 4t7itiatea hospitalofNanjing MedicalUniversity,Nanfing 210029,China Abstract 0bjectives:To study ics cefuroxime axetil tabletafter a single dose administration healthy :tIle study was designed atwo—treatment,two—period,two—sequence randomized cross—over concentrations were determined by LC—MS Sodium was used :The main ic parameters calculated by software were as foHows and the bioequivalence ics parameters were asfollows:CⅢwere(±)and (±)Ixg·L一1;t—were(-I-)hand(±)h;t