硫酸沙丁胺醇口腔崩解片人体生物等效性研究  

作　　者：赵宇明[1] 周远大[2] 何海霞[2] 

机构地区：[1]四川省邛崃市医疗中心医院,611530 [2]重庆医科大学附属第一医院临床药理研究室,400016

出　　处：《中外健康文摘》2009年第04X期26-28,共3页The Chinese and foreign health abstract

摘　　要：目的比较硫酸沙丁胺醇口腔崩解片和普通片的人体生物利用度。方法18名健康志愿受试者随机交叉单剂口服硫酸沙丁胺醇口腔崩解片和普通片，用高效液相色谱法测定血药浓度，3P97计算药动学参数和生物利用度。结果硫酸沙丁胺醇口腔崩解片和普通片体内药时曲线符合二室模型，崩解片和普通片Cmax分别为17．65±6．48ng·ml-1和1660±6．21ng·ml-1，Tmax分别为1．92±1．18h和2．03±1．17h，AUC（0-24）分别为127．23±32．41ng·h·ml-1和131．42±37．73ng·h·ml-1，相对生物利用度为99．32±15.58％。结论经方差分析和双单侧t检验，硫酸沙丁胺醇口腔崩解片和普通片具有生物等效性。Objective： To study the relative bioavailability and pharmacokinetics of salbuterol sulfate orally disintegrating tablet in 18 healthy male volunteers. Methods： A single dose of 8 mg salbuterol sulfate orally disintegrating tablet was administered by randomized crossover way in 18 volunteers and the plasma concentrations of salbutamol were determined by HPLC. The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioequivalenly was evaluated. Results： The concentration-time curve of two preparations fitted two compartment model. The peak plasma levels （Cmax）of salbuterol salfate orally disintegrating tablet and market of salbuterol sulfate were 17. 65±6.48 ng. ml-1and 16.60±6.21 ng. ml-1, respectively. The peak time（Tmax） were 1.92 ± 1.18h and 2.03 ＋ 1.17h. And AUC（0-24） were 127.23± 32.41 ng .h .ml-1and 131.42 ＋ 37.73 ng ·h .ml-1, respectively. The relative bioavailabitity of salbuterol salfate orally disintegrating tablet was 99.32± 15.58%. Conclusion： The results of two one-side tests suggests that salbuterol sulfate orally disintegrating tablet is bioequivalent to the market bablet of salbutamol.

关 键 词：硫酸沙丁胺醇口腔崩解片 药动学 生物等效性 

分 类 号：R363.1[医药卫生—病理学]