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目的 以法国罗赛尔公司生产的罗力得片为参比制剂 ,比较国产罗红霉素胶囊的人体生物利用度和生物等效性。方法 选择 10名男性成年健康志愿者 ,用自身交叉对照试验方法 ,分别单剂量一次口服罗红霉素胶囊和罗力得片两种制剂 30 0mg ,血药浓度采用微生物法测定。罗红霉素的血药浓度 时间数据用 3p87程序处理得药代动力学参数。结果 口服国产和进口两种制剂的血药浓度 曲线符合二室模型 ,Cmax分别为 (7.5 9± 1.43)mg/L和(7.5 4± 0 .93)mg/L ;Tmax分别为 (1.45± 0 .6 1)h和 (1.32± 0 .42 )h ;T β分别为 (13.37± 2 .4)h和 (13.6 5± 1 0 6 )h ;AUC分别为每小时 (98.89± 14.85 )mg·L-1和 (98.2 8± 19.49)mg·L-1。国产胶囊与进口片剂比较相对生物利用度为10 0 6 2 %。结论 经方差分析表明两种制剂的药代动力学参数间无显著性差异 (P >0 .0 5 ) ,经双单侧t检验 ,国产罗红霉素胶囊生物利用度与进口罗力得片比 ,具有生物等效性。
OBJECTIVE To compare the bioavailability and bioequivalence of roxithromycin capsules made in China by Luoerde tablets produced by France Rossel. Methods Ten male adult healthy volunteers were selected and 30 000 mg of roxithromycin capsules and Luo Li De tablets were orally administered by single-dose cross-over test respectively. The plasma concentration was determined by the microbiological method. Roxithromycin blood concentration time data using 3p87 program pharmacokinetic parameters. Results The plasma concentration curves of two domestic and orally administered oral preparations were in accordance with the two compartment model with Cmax of (7.59 ± 1.43) mg / L and (7.54 ± 0.93) mg / L, respectively; Tmax was (1.45 ± 0 .6 (1) h and (1.32 ± 0.42) h respectively; T β were (13.37 ± 2. 4) h and (13.6 5 ± 106) h, respectively; AUC was 98.89 ± 14.85 mg · h L-1 and (98.2 8 ± 19.49) mg · L-1. The relative bioavailability of domestic capsules compared with imported tablets was 10 0 6 2%. Conclusion Analysis of variance showed no significant difference between the pharmacokinetic parameters of the two preparations (P> 0.05) .Bilateral unilateral t-test, domestic bioavailability of roxithromycin capsules and imported tablets Compared with bioequivalence.