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目的 :研究健康人体内头孢氨苄分散片药动学及相对生物利用度。方法 :12名健康志愿受试者自身交叉口服头孢氨苄分散片和头孢氨苄片 5 0 0mg后 ,采用高效液相色谱法测定血清中头孢氨苄浓度。 结果 :头孢氨苄分散片和片剂的体内过程均符合一房室模型 ,AUC分别为 :(132 8.0± 30 3 .9)和 (130 4.4± 2 6 6 .7) μg·ml-1·min ;Tmax分别为 (2 6 .6± 15 .1)和 (4 6 .6± 9.2 )min ;Cmax分别为 (13.2± 4.9)和 (10 .2± 2 .9) μg·ml-1。经方差分析 ,两药Tmax间差异有显著性 ,其他药动学参数间差异无显著性 ;对于lnAUC ,双向单侧t检验表明 ,头孢氨苄分散片与片剂具有生物等效性。结论 :头孢氨苄分散片与头孢氨苄片剂具有生物等效性 ,头孢氨苄分散片的相对生物利用度为 (10 6 .6± 33.6 ) %。
Objective: To study the pharmacokinetics and relative bioavailability of cephalexin dispersible tablets in healthy volunteers. Methods: Twelve healthy volunteers were given crossover oral cephalexin tablets and cephalexin tablets at a dose of 500 mg. The concentrations of cephalexin in serum were determined by high performance liquid chromatography (HPLC). Results: The in vivo process of cephalexin dispersible tablets and tablets were in accordance with one-compartment model with AUC of (132 8.0 ± 30 3 .9) and (130 4.4 ± 26.67) μg · ml -1 · min ; Tmax was (26.6 ± 15.1) and (46.6 ± 9.2) min, respectively; Cmax was (13.2 ± 4.9) and (10.2 ± 2.9) μg · ml-1, respectively. By ANOVA, there was significant difference between the two drugs Tmax, no significant difference between other pharmacokinetic parameters; for lnAUC, two-way one-sided t-test showed that cephalexin dispersible tablets and tablets with bioequivalence. Conclusion: Cefalexin dispersible tablets and cephalexin tablets have bioequivalence. The relative bioavailability of cephalexin dispersible tablets is (106.6 ± 33.6)%.