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目的 :研究克拉霉素胶囊在正常人体内的药动学与相对生物利用度。方法 :以藤黄八叠球菌 2 80 0 1为敏感菌株 ,采用微生物法测定 10名健康志愿受试者 po单剂量克拉霉素胶囊和进口片剂 (5 0 0mg)后血清中克拉霉素的浓度 ;以PKBP N1程序处理测定结果 ,计算药动学参数 ;用双单侧t检验法和配对t检验法对主要的药动学参数进行统计分析 ,评价二者的生物等效性。结果 :微生物法的最低检测浓度为 0 .0 5 μg·ml-1,线性范围 0 .0 5～ 4.0 0 μg·ml-1,回收率为 99.0 4%～ 10 1.48% ,RSD≤8.2 0 % ;克拉霉素在人体内的药动学行为均符合一级吸收的开放一室模型 ,二者的达峰时间分别为 (1.45± 0 .5 0 )h和 (1.5 5± 0 .44 )h ,峰浓度分别为 (2 .2 0± 0 .39) μg·ml-1和 (2 .15± 0 .33) μg·ml-1,血浓经时曲线下面积分别为 (17.6 0± 2 .85 ) μg·h·ml-1和 (17.74± 3.46 ) μg·h·ml-1。结论 :以克拉霉素进口片为参比 ,计算得克拉霉素胶囊的相对生物利用度为 10 1.6 4% ,二者生物等效。
Objective: To study the pharmacokinetics and relative bioavailability of clarithromycin capsules in normal human. Methods: To determine the effects of clarithromycin in the serum of spermatozoa mesonii 2 80 01 on the sensitivity and stability of the clarithromycin capsules and the imported tablets (500 mg) of 10 healthy volunteers The pharmacokinetic parameters were calculated by PKBP N1 program. The main pharmacokinetic parameters were statistically analyzed by double unilateral t-test and paired t-test to evaluate the bioequivalence of the two pharmacokinetic parameters. Results: The lowest detection concentration was 0. 05 μg · ml-1 by microbiological method, the linear range was 0.05-0 4.0 0 μg · ml-1, the recovery was 99.0 4% -10 10.48%, RSD ≤ 8.2% ; Clarithromycin pharmacokinetic behavior in the human body are in line with the first-order absorption of an open-studio model, the peak time of the two were (1.45 ± 0.55) h and (1.55 ± 0.44) h , The peak concentrations were (2.20 ± 0.39) μg · ml-1 and (2.15 ± 0.33) μg · ml-1, respectively, and the areas under the curve of blood concentration over time were (17.6 ± 2) .85) μg · h · ml-1 and (17.74 ± 3.46) μg · h · ml-1. CONCLUSIONS: The relative bioavailability of clarithromycin capsules was calculated to be 10 1.6 4% based on the imported clarithromycin tablets, both of which were bioequivalent.