摘要
研究了 2 0名健康志愿者单剂量口服两种阿奇霉素片后的血药浓度经时过程 ,以及两者的生物等效性评价。以微生物法测定血清中阿奇霉素的浓度 ,供试制剂的 Cmax为 5 80 .75± 15 6 .6 2 μg/ L,Tmax为 1.6 0± 0 .6 8h,t1 /2 为 36 .6 0± 3.74h,MRT为 40 .30± 5 .43h,AUC0 - 1 4 4 为 44 91.0 3± 979.0 5 μg· h· L- 1。与参比制剂 Tmax(2 .45± 0 .6 9h)比较 ,除供试剂 (Tmax1.6 0± 0 .6 8h)达峰时间明显提前 ,其他药物动力学参数经方差分析均无显著差异 (P>0 .0 5 ) ,供试制剂的相对生物利用度为 97.14± 11.2 8%。经双单侧 t检验 。
The concentration time process of azithromycin tablets in 20 healthy volunteers was observed. The plasma concentrations of azithromycin were determined by microbiological method. The pharmacokinetic parameters for the single oral dose of tested tablets were C max 580.75±156.62 μg/L, T max 1.60±0.68 h, t 1/2 36.60±3.74 h, MRT 40.30±5.43 h and AUC 0→144 4491.03±979.05 μg·h·L -1 . The main pharmacokinetic parameters were not significantly different between the tested and reference tablets, except T max (2.45±0.69 h for the latter). The relative bioavalability of tested tablets was 97.14±11.28%.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2001年第5期215-217,共3页
Chinese Journal of Pharmaceuticals
