头孢他美酯片人体相对生物利用度研究

Relative Bioavailability of Cefetamet Pivoxil Tablet in Healthy Volunteers

目的：比较国产头孢他美酯片与进口头孢他美酯片的人体相对生物利用度。方法：18名健康成年男子，采用随机分组自身交叉对照试验设计方法，分别单剂量口服500 mg国产和进口头孢他美酯片剂。用HPLC法测定头孢他美的血药浓度。结果：进口与国产药的主要药代动力学参数分别为：T1/2：2.22±0.29和2.37±0.31 h；Tmax：2.78±0.97和3.25±0.88 h；Cmax：5.55±1.31和5.49±0.85 mg·L-1；AUC0-t：29.14±5.87和30.74±5.27 mg·h·L-1；试验药头孢他美的相对生物利用度为106.85±11.95％。结论：经统计分析，两种制剂为生物等效制剂。

CAO Xiao-Mei1 LIU Min2 BU Yi-SHan3 CHANG CHeng-Fang4 ZHUO Hai-Tong1 LIN SHu-Seng1 1(Department of Clinical Pharmacology, General Hospital of Armed Forces of Nanjing, Nanjing 210002) 2(Department of Pharmacy,Ezhou Steel Company Hospital, Ezhou 436002) 3(Department of Pharmacy, the First Central Hospital of Tianjin, Tianjin 300192) 4(Department of Pharmacy,Huang He Hospital of San Men Xia, San Men Xia 452100) Abatract OBJECTIVE: To study the pharmacokinetics and relative bioavailability of domestic and imported cefetamet pivoxil tablet. METHODS: A single oral dose of 500 mg cefetamet pivoxil was given to 18 healthy volunteers in a randomized crossover study. Concentrations of cefetamet were determined by HPLC method. RESULTS: The pharmacokinetics parameters of domestic and imported drug were T1/2 2.22±0.29 and 2.37±0.31 h, Tmax 2.78±0.97 and 3.25±0.88 h, Cmax 5.55±1.31 and 5.49±0.85 mg·L-1, AUC0-t 29.14±5.87 and 30.74±5.27 mg·h·L-1.The relative bioavailability of domestic to imported tablets were 106.85±11.95. CONCLUSION: The results of two one-sided tests statistical analysis and rank sum test showed that two formulations were bioequivalent.