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8名健康男性志愿者自身交叉单剂量口服 5 0 0mg克拉霉素颗粒剂和片剂 ,采用微生物法测定经时过程血药浓度 .用 3P87程序拟和 ,两制剂的血药浓度 时间曲线均符合单室模型 .求得克拉霉素颗粒剂和片剂药物动力学参数 .Ka分别为 (3.5 5± 0 .92 )和 (1.6 2± 0 .16 )h-1;t1/2 分别为(4.90± 0 .19)和 (5 .0 6± 0 .2 5 )h ;Cmax分别为 (2 .6 3± 0 .2 7)和 (2 .2 9± 0 .2 6 ) μg/mL ;Tmax分别为(1.12± 0 .10 )和 (1.6 8± 0 .0 6 )h ;AUC分别为 (2 1.6 7± 2 .5 4)和 (2 1.13± 3.19) μg·h/mL .经统计学处理 :两制剂的药动学参数Ka、Cmax、Tmax均有显著性差异 (P <0 0 5 ) ,t1/2 无显著性差异 (P >0 0 5 ) ,克拉霉素颗粒剂相对于片剂的生物利用度F为 (10 3.36± 11.15 ) % .经方差分析、单双侧检验法分析 ,证明两制剂具有生物等效性 .
Eight healthy male volunteers crossed their own oral doses of 500 mg clarithromycin granules and tablets, and the blood concentration of the time course was determined by the microbiological method.The plasma concentration time curves of the two preparations coincided with the 3P87 program Single compartment model. The pharmacokinetic parameters of clarithromycin granules and tablets were obtained. The values of ka were (3.55 ± 0.92) and (1.6 ± 0.16) h-1, respectively; t1 / 2 were ± 0.19) and (5.06 ± 0.52) h, respectively; Cmax were (2.63 ± 0.27) and (2.29 ± 0.26) μg / mL, respectively; (1.12 ± 0.10) and (1.6 8 ± 0.06) h, respectively; AUC was (2 1.6 7 ± 2 .5 4) and (2 1.13 ± 3.19) μg · h / mL, respectively Treatment: The pharmacokinetic parameters Ka, Cmax, Tmax of the two preparations were significantly different (P <0 05), t1 / 2 no significant difference (P 0 05), clarithromycin granules relative to tablets The bioavailability of the agent F was (10 3.36 ± 11.15)% .Analysis of variance and single-sided test showed that the two preparations were bioequivalent.