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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。
Objective: To compare the relative bioavailability of domestic cefetamet and imported cefetamet. Methods: Eighteen healthy adult men were randomized to receive a single oral dose of 500 mg of domestic and imported ceftazidime tablets. Determination of Ceftazidime by HPLC. Results: The main pharmacokinetic parameters of imported and domestic drugs 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, respectively. The relative bioavailability of cefetamet was 106.85 ± 11.95%. Conclusion: According to statistical analysis, the two preparations are bioequivalent.