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以藤黄八迭球菌为指示菌,采用微生物法测定 10 名志愿者阿奇霉素分散片(实验制剂)和胶囊(参比制剂)经时血药浓度。最低检测限度 0005μg/m l,线性范围 001~04μg/m l。实验采用双交叉单剂口服给药设计,数据经 3 P97 药代动力学程序处理,阿奇霉素实验制剂和参比制剂主要药物动力学参数 ka为07219±0.0755h- 1 和 0.7552±0.0593h- 1,t1/2(α)为 2.3188±0.2438h 和 2.3518±0.3811h,t1/2 (β)为41.5810 ±2. 2285h 和 44.1283±9.8643h, Cm ax 为 0.2458 ±0.0058μg/m l 和 0.2383±0.0061μg/m l, A U C0~120为 0.4170±0.0874μg/(m l·h )和 0.3877±0.0962μg/(m l·h ),实验制剂相对生物利用度为107.0566% 。经双单侧t检验和(12α)置信区间法分析,两种制剂主要药代动力学参数剂型间、阶段间和个体间差异均无显著性( P> 0.05),证实二者具有生物等效性。
Using Garcinia cambogia as indicator bacteria, 10 volunteers azithromycin dispersible tablets (experimental preparations) and capsules (reference preparations) were tested for blood concentration by the method of microbe. The minimum detection limit of 0 005μg / ml, the linear range of 0 01 ~ 0 4μg / m l. The experiment was designed by double crossover single dose oral administration. The data were processed by 3P97 pharmacokinetic program. The main pharmacokinetic parameters ka of azithromycin experimental and reference preparations were 07219 ± 0.0755h-1 and 0.7552 ± 0.0593h-1, t1 / 2 (α) was 2.3188 ± 0.2438h and 2.3518 ± 0.3811h, t1 / 2 (β) was 41.5810 ± 2. 2285h and 44.1283 ± 9.8643h respectively, Cm ax was 0.2458 ± 0.0058 μg / ml and 0.2383 ± 0.0061 μg / ml, and AUC0-120 was 0.4170 ± 0.0874 μg / ( ml · h) and 0.3877 ± 0.0962μg / (ml · h), respectively. The relative bioavailability of the experimental preparation was 107.0566%. The two single-sided t-test and (1 2α) confidence interval analysis of the two formulations of the main pharmacokinetic parameters between dosage forms, stages and between individuals showed no significant difference (P> 0.05), confirmed that both Bioequivalence.