健康志愿者口服国产头孢呋辛酯片的药动学

Pharmacokinetics of cefuroxime axetil domestic tablet in healthy volunteers

目的 :研究头孢呋辛酯片在健康志愿者体内的药动学。方法 :健康志愿者单剂量 ( 5 0 0mg)口服头孢呋辛酯片 ,用高效液相色谱法测定血清中头孢呋辛浓度 ,计算药动学参数。结果 :本方法在 0 .0 75～ 9.6mg·L-1范围内线性关系良好 (r =0 .9999) ,日内、日间精密度均小于 10 % ,平均回收率为 94 .3 3 %。头孢呋辛酯片的主要药动学参数Cmax为 ( 4 .5± 1.7)mg·L-1,Tmax为 ( 1.9± 0 .7)h ,AUC0→∞ 为 ( 2 1.6± 6.1)mg·L-1·h。结论 :测定方法操作简便 ,灵敏度高 ,无干扰。

OBJECTIVE To study pharmacokinetics of cefuroxime axetil tablet in 20 healthy volunteers.METHODS A single oral dose of the tablet was given to 20 healthy male volunteers.Cefuroxime concentration in serum was determined by RP HPLC.Pharmacokinetic parameters were calculated.RESULTS This method showed good linear relationship from 0.075 ～ 9.6 mg·L -1 ( r = 0.9999 ).The intraday and interday precision were less than 10%. The average recovery of the method was 94.33 %.After a single oral dose,the main pharmacokinetic parameters of domestic cefuroxime axetil tablet were as following: C max ( 4.5 ± 1.7 ) mg·L -1 , T max ( 1.9 ± 0.7 ) h, AUC 0→t ( 21.6 ± 6.1 ) mg·L -1 ·h, respectively.CONCLUSIONS This method is simple,senstive and specific.This study will provide a scientific basis for the clinical application.