头孢特仑酯药物动力学及生物利用度研究

Pharmacokinetics and relative bioavalability of cefteram pivoxil

目的建立了人血浆中头孢特仑的HPLC方法，测定其片剂、干混悬剂的药物动力学参数及相对生物利用度。方法血样用甲醇沉淀、高速离心后进入液相分析，色谱柱：Agilent Zorbax C18（3．0mm×150mm,5μm），流动相为甲醇-水-HAC-TEA=35：65：0．6：0．3，检测波长为262nm。结果在0．0475～4．75μg·mL^-1峰面积值与浓度线性关系良好（r=0．9999），定量下限为0．0475μg·mL^-1。绝对回收率为76．8％～83．3％。18名健康受试者随机交叉口服头孢特仑酯片剂、干混悬剂和进口头孢特仑酯片后，F0-τ分别为102．6％±13．4％和103．0％±8．8％。结论3种制剂生物等效。

OBJECTIVE To establish an HPLC method for the determination of cefteram pivoxil in the human plasma and to study its relative bioavailability. METHODS The plasma and methanol were vortexed and centrifuged, and the clear supemate was analyzed by Zorbax C18 column with the mobile phase of methanol-water-HAC-TEA solution （85 ： 15 ： 0. 6 ： 0. 3） . RESULTS Cefteram pivoxil was linear in the range of 0.047 5-4. 75μg·mL^-1. The limit detection concentration was 0. 047 5 μg·mL^-1 and the recovery was 76. 8% -83.3%. The relative bioavailability of the two drugs were （102. 6±13. 4）% and （103. 0±8. 8）% after the oral administration of cefteram pivoxil preparation. CONCLUSION The three formulations were bio-equivalent.