头孢妥仑匹酯(ME-1207)新制剂人体生物利用度研究  

RELATIVE BIOAVAILABILITY OF THE NEW CEFDITOREN PIVOXIL(ME-1207) TABLET IN HEALTHY VOLUNTEERS

作　　者：张莉[1] 李家泰[1] 赵彩云[1] 刘燕[1] 王婉青 

机构地区：[1]北京医科大学第一医院临床药理研究所,北京100034

出　　处：《中国临床药理学杂志》1999年第5期343-345,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：本文研究了16名男性健康志愿者分别交叉口服头孢妥仑匹酯新、旧两种片剂200mg后的生物等效性。采用高效液相色谱法测定血及尿药浓度。主要药代动力学参数如下 :新、旧制剂的平均峰浓度Cmax为2.51±0.53,2.57±0.58mg·L-1;达峰时间Tpeak 为1.41±0.20,1.44±0.17h;药时曲线下面积AUC0 -t 为7.16±1.48,7.27±1.72mg·h·L-1;消除半衰期T1/2ke,1.36±0.16,1.35±0.16h。新、旧两种制剂24h尿药累积排泄率( %)分别为18.55±4.04,19.23±4.11。ME -1207新片剂的相对生物利用度为99.4 %。经统计分析判定新片剂与旧片剂生物等效。A single oral dose of 200 mg new and old cefditoren pivoxil tablets were studied in 16 male healthy volunteers. Drug concentrations in plasma and urine were determined by HPLC method. The results showed that Tmax of new and old tablets were 1.41±0.20 and 1.44±0.17 h; Cmax were 2.51±0.53 and 2.57±0.58 mg·L-1; T1/2ke were 1.36±0.16 and 1.35±0.16 h; AUC were 7.16±1.45 and 7.27±1.72 mg·h·L-1, respectively, while the urinary excretion rate as percentage of the dose were 18.55±4.04% and 19.23±4.11%, respectively. The pharmacokinetic parameters showed no significant difference between two products (P>0.05).The AUC of equivalency test showed that two tablets were bioequivalent. The relative bioavailability of new to old tablet was 99.4%.

关 键 词：头孢妥仑匹酯 生物利用度 高效液相色谱法 

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