摘要
目的:比较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:口腔崩解片和普通片体内药时曲线符合二室模型,口腔崩解片和普通片Cmax分别为17.4 8±5 .5 2、16 .6 0±6 .2 1ng/ml,Tmax分别为2 .4 7±1.0 4和2 .0 3±1.17h ,AUC(0 -2 4) 分别为12 7.34±32 .6 6和131.4 2±37.73ng·h/ml,相对生物利用度为98.76 %±12 .92 %。结论:经方差分析和双单侧t检验。
Objective:To study the relative bioavailability and pharmacokinetics of salbutamol orally disintegrating tablet in 18 healthy male volunteers.Methods:A single dose of 8 mg of salbutamol orally disintegrating tablet was administered in a 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 bioavailability was evaluated.Results:The concentration-time curve of two preparations fitted two compartment model.The peak plasma levels(cmax) of salbutamol orally disintegrating tablet and market of salbutamol were 17.48±5.52 and 16.60±6.21 ng/ml,respectively.The peak time(Tmax) were 2.47±1.04 and 2.03±1.17h and AUC(0-24) were 127.34±32.66 and 131.42±37.73 ng·h/ml,respectively,The relative bioavailability of salbutamol orally disintegrating tablet was 98.76%±12.92%.Conclusion:The results of two one-side tests suggest that salbutamol orally disintegrating tablet is bioequivalent to the market tablet of salbutamol.
出处
《重庆医科大学学报》
CAS
CSCD
2005年第2期289-291,共3页
Journal of Chongqing Medical University
关键词
沙丁胺醇口腔崩解片
药动学
生物等效性
Salbutamol orally disintegrating tablet
Pharmacokinetics
Bioequivalence
