国产头孢泊肟酯片的生物等效性研究  

Study on bioequivalence of domestic and imported cefpodoxime proxetil tablets

作　　者：申屠建中[1] 吴丽花[1] 章霞[1] 陈志根[1] 汪涛[1] 史美甫[1] 

机构地区：[1]浙江大学医学院附属第一医院临床药理研究室,杭州310003

出　　处：《中国新药杂志》2002年第9期716-718,共3页Chinese Journal of New Drugs

摘　　要：目的 :研究国产头孢泊肟酯片的生物等效性。方法 :2 4例健康成年男性志愿者采用随机分组自身对照交叉试验设计法 ,单次口服国产和进口头孢泊肟酯片 2 0 0mg ,用反相高效液相色谱法测定血清中头孢泊肟浓度 ,并用 3P97程序对试验数据进行处理。结果 :国产和进口头孢泊肟酯片的Tmax 分别为 (2 .2 7± 0 .4 9)和 (2 .5 0±0 .6 1)h ,Cmax分别为 (3.6 4± 0 .5 3)和 (3.4 8± 0 .5 7)mg·L- 1 ,AUC0 -t分别为 (18.12± 2 .79)和 (17.95± 3.0 7)mg·hL- 1 ;国产头孢泊肟酯片的相对生物利用度为 (10 2 .31± 15 .4 0 ) %。结论 :国产与进口头孢泊肟酯片具有生物等效性。Objective:To study the bioequivalence of domestic and imported cefpodoxime proxetil (CPDX-PR) tablets.Methods:A single dose of 200mg domestic and imported CPDX-PR tablets were given to 24 male healthy volunteers in a randomized two way crossover design.The cefpodoxime level in serum were determined by RP HPLC and data obtained were analyzed by 3P97 program.Results:The T max , C max ,AUC 0-t of domestic and imported tablets were (2.27±0.49) and (2.50± 0.61)h, (3.64±0.53) and (3.48±0.57) mg·L -1 ,(18.12±2.79) and (17.95±3.07)mg·h·L -1 ,respectively.The relative bioavailability of domestic tablets was (102.31±15.40)%.Conclusion:The domestic and imported CPDX-PR tablets were bioequivalent.

关 键 词：高效液相色谱 药物代谢动力学 头孢泊肟酯片 生物等效性 

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