Pharmacokinetics and Bioequivalence of Cefprozil Granules and Cefprozil Tablets in Healthy Chinese Volunteers  

头孢丙烯颗粒与片在健康志愿者体内的药动学及生物等效性(英文)

作　　者：李小利[1] 倪梅媛[2] 王本杰[1] 郭瑞臣[1] 

机构地区：[1]山东大学齐鲁医院临床药理研究所,山东济南250012 [2]山东大学齐鲁医院制剂科,山东济南250012

出　　处：《Journal of Chinese Pharmaceutical Sciences》2006年第4期243-247,共5页中国药学（英文版）

摘　　要：Aim To develop a rapid, simple, and sensitive high-performance liquid chromatographic (HPLC) method for the determination of cefprozil in human plasma and to study its pharmacokinetics and bioequivalence after 0.5 g oral doses of cefprozil granules and tablets. Methods The blood concentration of cefprozil was analyzed after extracted with 6% trichloroacetic acid, using tinidazole as internal standard (I.S.). A C_ 18 column was used to separate cefprozil with mobile phase of methanol, purified water and glac...目的建立生物样本头孢丙烯血浓度HPLC测定方法,进行头孢丙烯颗粒与头孢丙烯片健康志愿者体内药动学和相对生物等效性研究。方法 20名健康男性志愿者随机交叉单剂量口服头孢丙烯颗粒和头孢丙烯片各0·5 g,采用高效液相色谱法测定给药后不同时间血浆浓度,计算其主要药动学参数。结果头孢丙烯颗粒与头孢丙烯片主要药动学参数t1/2为1·970 ±0.388 h和2.046 ±0.449 h,Tmax为1.600 ±0.348 h和1.675 ±0.335 h,Cmax为6.643 ±1.104μg·mL-1和6.637 ±1.320μg·mL-1,AUC0 -12为21.586 ±4.154μg·mL-1·h和21.121 ±4.255μg·mL-1·h,AUC0 -∞为21.814 ±4.164μg·mL-1·h和21.388 ±4.308μg·mL-1·h,头孢丙烯颗粒相对生物利用度为103.138 % ±12.042 %。结论本文所建立的HPLC方法灵敏,简单,可用于头孢丙烯人体药动学及生物等效性研究。AUC0 -12,AUC0 -∞,Cmax和Tmax方差分析,双单侧检验及90%置信限分析显示,两制剂具有生物等效性。

关 键 词：CEFPROZIL PHARMACOKINETICS BIOEQUIVALENCE HPLC 

分 类 号：R94[医药卫生—药剂学]