采用液-质联用法测定头孢吡肟片健康人体药动学和生物等效性

目的：研究头孢吡肟片生物等效性。方法：采用液-质联用法测定血浆中头孢吡肟浓度。20名健康受试者随机交叉单剂量口服头孢吡肟片对照药物和测试药物500 mg，测定不同时间血药浓度；DAS软件处理药-时数据。结果：与对照药物相比，测试药物生物利用度F₀^t为（105.83±16.31）%，F₀^∞为（108.36±15.38）%；测试药物与对照药物的主要药动学参数t_max分别为（3.89±0.30） h和（3.68±0.59） h，C_max分别为（15.22±1.36） mg·L^-1和（14.28±1.99） mg·L^-1，t_1/2ke分别为（4.52±0.79） h和（4.36±0.83） h，AUN₀^t分别为（15.97±2.87） mg·h·L^-1和（16.13±3.02） mg·h·L^-1，AUC₀^∞分别为（16.22±2.99） mg·h·L^-1和（16.88±3.12） mg·h·L^-1。对两制剂间的AUC₀^t、AUC₀^∞、C_max、t_max等进行双向单侧t检验，表明2种制剂具有生物等效性。结论：两药物等效。

Study on pharmacokinetics and bioequivalence of cefepime tablets in healthy volunteers by HPLC-MS

OBJECTIVE To study the bioavailability of cefepime tablets.METHODS The concentration of cefepime in plasma was determined by HPLC-MS method. 20 healthy subjects were randomized to a single dose of oral administration of cefepime tablets and the preparation of 500 mg, the plasma concentration of DAS was measured at different time.RESULTS Compared with the reference preparation, trial by agent bioavailability (105.83+16.31)% and (108.76+15.38)%; by test preparation and reference preparation of the main pharmacokinetic parameters of t_max were (3.89+0.30) h and (3.68+0.59) h respectively, C_max(15.22+1.36) mg·L^-1 and (14.28+1.99) mg·L^-1 respectively, t_1/2ke (4.52+0.79) h and (4.36+0.83) h, respectively.AUC₀^t (15.97+2.87) mg·h·L^-1 and (16.13+3.02) mg·h·L^-1respectively. AUC₀^∞ (16.22+2.99) mg·h·L^-1 and (16.88+3.12) mg·h·L^-1. The two agents, C_max, t_max and other two one-sided t test showed that the two formulations are bioequivalent.CONCLUSION The preparation is equivalent with the cefepime tablets