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目的 :研究克拉霉素分散片在健康人体内的相对生物利用度 ,评价其生物等效性。方法 :采用微生物法测定 9名受试者单剂量交叉口服 5 0 0mg克拉霉素分散片和片剂后不同时间血清中药物浓度 ,用 3P87程序软件处理血药浓度 时间数据。结果 :2制剂体内过程均符合一室模型 ,Cmax分别为 (3.0 9± 0 .2 9)mg·L-1和 (2 .98± 0 .37)mg·L-1;Tmax分别为 (1 .37± 0 .35 )h和 (1 .5 6± 0 .42 )h ;T1/ 2 分别为 (4.0 7± 0 .92 )h和 (4.0 9± 0 .71 )h ;AUC为 (2 2 .6± 3.6 )mg·h·L-1和 (2 3.0 0± 3.90 )mg·h·L-1,被试制剂的相对生物利用度为 (98.7± 1 0 .9) % (82 .5 %～ 1 1 7.4% )。结论 :2种制剂具有生物等效性。
Objective: To study the relative bioavailability of clarithromycin dispersible tablets in healthy volunteers and evaluate its bioequivalence. Methods: The concentration of drug in serum was determined by microbiological method at different time after oral administration of 500 mg clarithromycin dispersible tablets and tablets in 9 subjects, and the plasma concentration time data were processed by 3P87 program software. Results: The in vivo process of the two preparations were in accordance with the one-compartment model with Cmax of (3.09 ± 0.29) mg · L-1 and (2.98 ± 0.37) mg · L-1, respectively .37 ± 0.35) h and (1.56 ± 0.42) h; T1 / 2 were (4.07 ± 0.92) h and (4.09 ± 0.71) h, respectively; AUC was (2 The relative bioavailability of test preparation was 98.7 ± 1.09% (82.6 ± 3.6) mg · h · L-1 and (2.30 ± 3.90) mg · h · L-1, respectively. 5% to 1 1 7.4%). Conclusion: The two preparations are bioequivalent.