头孢泊肟酯片和颗粒人体相对生物等效性试验研究

目的研究国产头孢泊肟酯片及颗粒与进口头孢泊肟酯片在24名男性健康志愿者体内的生物等效性。方法采用标准3制剂、3周期的二重3×3拉丁方式自身对照试验设计,24例男性健康志愿受试者单剂量口服国产头孢泊肟酯颗粒（受试制剂A）、头孢泊肟酯片（受试制剂B）和进口头孢泊肟酯片（参比制剂R）。药物血清质量浓度以高效液相色谱法测量,药代动力学参数采用3P97和ndst21w软件处理。结果头孢泊肟酯受试制剂A、受试制剂B和参比制剂R的达峰时间（Tmax）分别为（2.81±0.51）h,（2.85±0.54）h,（2.92±0.52）h,峰浓度（Cmax）分别为（3.44±0.93）μg/mL,（3.32±0.74）μg/mL,（3.47±0.80）μg/mL,0～12h药时曲线下面积（AUC0-12h）分别为（20.02±5.61）μg·h/mL,（19.28±4.23）μg·h/mL,（19.59±5.18）μg·h/mL。受试制剂A和受试制剂B对参比制剂R的相对生物利用度分别为103.16%和100.65%。结论 3种头孢泊肟酯制剂在人体内具有生物等效性。

Study on Relative Bioequivalence of Domestic Cefpodoxime Proxetil Tablets and Granules

Objective To study the bioequivalence of domestic cefpodoxime proxetil tablets and granules compared with imported cefpodoxime proxetil tablets in 24 healthy male volunteers.Methods Twenty-four volunteers were distributed into three groups by Latin square design with a single oral domestic cefpodoxime tablet（test A） and granules（test B）,and imported cefpodoxime tablet（reference）.The plasma concentration of cefpodoxime was determined by HPLC method.The pharmacokinetic parameters were calculated by 3P97 and ndst21w softwares.Results The main pharmacokinetic parameters of test A,B and reference preparation were as follows：Tmax were（2.81 ± 0.51） h,（2.85 ± 0.54） h and（2.92 ± 0.52） h respectively;Cmax were（3.44 ± 0.93） μg /mL,（3.32 ± 0.74） μg /mL and（3.47 ± 0.80） μg /mL respectively;AUC（0-12 h）were（20.02 ± 5.61）μg·h /mL,（19.28 ± 4.23） μg·h /mL and（19.59 ± 5.18）μg·h /mL,respectively.The relative bioavailabilities of test A and B were 103.16% and 100.65%,respectively.Conclusion The three preparations of cefpodoxime proxetil are bioequivalent.