【摘要】 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 ０００５μｇ／ｍ ｌ，线性范围 ００１～０４μｇ／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０７２１９±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（１２α）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。更多还原

【Abstract】 The bioavailability and bioequivalence of azithromycin capsules and desperse tablets were studied on 10 healthy volunteers with a duble crose over design test. The serum level after a single oral dose of azithromycin 500mg were determined using a micrological (Sarcina lutea) assay. The ka, t 1/2 (α), t 1/2 (β), Tmax, Cmax and AUC 0～120 of test and reference calculated with 3P97 pharmacokinetical programme are 0.7219 ±0.0755h -1 and 0.7552±0.05993h -1 ,2.3188±0.2438h and 2.3518±0.3811h,41.5810±2.2285h and 44.1283±9.8643h,0.2458±0.0058μg/ml and 0.2383±0.0061μg/ml,0.4170±0.0874μg/(ml·h) and 0.3876±0.0962μg/(ml·h) respectively. The relative bioavailability of azithromycin desperse tablets are 107.0566% . The bioequivalence acessed by Bayesion and Westlake approaches, and two one sided tests of the two preparations show no significant differences.更多还原