头孢泊肟酯片人体相对生物利用度和生物等效性  

Relative bioavailability of cefpodoxime proxetil tablets in healthy volunteers

作　　者：韩静[1] 杨漫[1] 宋玉环[1] 王振龙[1] 王涛[1] 王晓琳[1] 刘会臣[1] 

机构地区：[1]航天中心医院临床药理室,北京100049

出　　处：《中国医院药学杂志》2011年第6期440-443,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:考察头孢泊肟酯片受试制剂和参比制剂的人体相对生物利用度,并评价两者的生物等效性。方法:22名健康男性志愿者随机交叉单剂量口服头孢泊肟酯片受试制剂200mg和参比制剂200mg,用HPLC法测定给药后血浆样本中头孢泊肟的浓度,用DAS软件计算其药动学参数,并评价两种制剂的相对生物利用度。结果:受试制剂和参比制剂的tmax分别为(2.6±0.6)和(2.9±0.7)h,Cmax分别为(2.9±0.8)和(3.4±0.6)mg.L-1,t1/2分别为(2.4±0.6)和(2.14±0.23)h,AUC0-t分别为(16.1±4.0)和(18.2±3.6)mg.h.L-1,AUC0-∞分别为(17.0±3.9)和(19.1±3.7)mg.h.L-1。受试制剂的相对生物利用度F0-tn和F0-∞分别为(88.6±15.6)%、(89.8±14.7)%。结论:两种制剂具有生物等效性。OBJECTIVE To investigate the pharmacokinetics and bioequivalence of cefpodoxime proxetil tablets and reference tablets in healthy volunteers. METHODS A single oral dose of 200 mg cefpodoxime proxetil test and reference tablets were given to 22 healthy male volunteers in a randomized, two way crossway study. Cefpodoxime concentrations in plasma were determined by HPLC. With use of DAS software, the pharmacokinetic parameters were calculated and the bioequivalence of the two preparations was evaluated. RESULTS The main pharmaeokinetic parameters of test and reference preparations were as follows：tmax were （2.6±0 6 ） and （2. 9±0. 7）h;Cmax were （2.9±0.8） and （3.4±0.6） mg· L^-1;t1/ 2 were （2.4±0.6） and （2. 14±0.23） h; AUG0-t were （16. 1 ±4.0） and （18.2±3.6） mg· h · L ^-1; AUG0-∞ were （17. 0±3.9） and （19. 1 ±3.7） mg·h^-1 , respectively. The F0-t and F0-∞ of test tablet were （88.6 ± 15.6）% and （89. 8 ± 14. 7）%. CONCLUSION The two preparations are bioequivalent.

关 键 词：头孢泊肟 高效液相色谱法 生物利用度 生物等效性 

分 类 号：R969.1[医药卫生—药理学]