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本文研究了16名男性健康志愿者分别交叉口服头孢妥仑匹酯新、旧两种片剂200mg后的生物等效性。采用高效液相色谱法测定血及尿药浓度。主要药代动力学参数如下 :新、旧制剂的平均峰浓度Cmax为2.51±0.53,2.57±0.58mg·L-1;达峰时间Tpeak 为1.41±0.20,1.44±0.17h;药时曲线下面积AUC0 -t 为7.16±1.48,7.27±1.72mg·h·L-1;消除半衰期T1/2ke,1.36±0.16,1.35±0.16h。新、旧两种制剂24h尿药累积排泄率( %)分别为18.55±4.04,19.23±4.11。ME -1207新片剂的相对生物利用度为99.4 %。经统计分析判定新片剂与旧片剂生物等效。
This study investigated the bioequivalence of 16 male healthy volunteers who had received oral and oral administration of 200 mg of both cefditoren pivoxil and 200 mg of the two older tablets respectively. Determination of blood and urine concentration by high performance liquid chromatography. The main pharmacokinetic parameters are as follows: the average peak concentration of new and old preparations Cmax 2.51 ± 0.53,2.57 ± 0.58mg · L-1; peak time Tpeak 1.41 ± 0.20,1.44 ± 0.17h; under the curve area AUC0-t was 7.16 ± 1.48,7.27 ± 1.72mg · h · L-1; elimination half-life T1 / 2ke, 1.36 ± 0.16,1.35 ± 0.16h. The cumulative urinary excretion rate (%) of new and old preparations for 24h was 18.55 ± 4.04 and 19.23 ± 4.11, respectively. The relative bioavailability of ME-1207 new tablet was 99.4%. The statistical analysis determined that the new tablet was bioequivalent to the old tablet.