硫酸沙丁胺醇口腔崩解片人体生物等效性研究

Bioavailability of Salbutamol Sulfate Orally Disintegrating Tablets in Healthy Subjects

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 ,以3p97程序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 48)ng/ml和 (16 60±6 21)ng/ml,Tmax 分别为 (1 92±1 18)h和 (2 03±1 17)h ,AUC0～24 分别为 (127 23±32 41)ng/(h·ml)和 (131 42±37 73)ng/(h·ml) ,相对生物利用度为 (99 32±15 58) %。结论

OBJECTIVE:To study the relative bioavailability and pharmacokinetics of salbutamol sulfate orally disinteˉgrating tablets.METHODS:A single dose of8mg salbutamol sulfate orally disintegrating tablets or commercial salbutamol tablets was administered in a randomized crossover design in18volunteers and the plasma concentrations of salbutamol were determined by HPLC.The pharmacokinetic parameters were calculated with3p97pharmacokinetic program and the bioequivˉalency was evaluated.RESULTS:The concentration-time curve of two preparations fitted to two-compartment model.The peak plasma levels(C max )of salbutamol sulfate orally disintegrating tablet and commercial salbutamol sulfate tablet were(17.65±6.48)ng/ml and(16.60±6.21)ng/ml,respectively.The peak time(T max )were(1.92±1.18)h and(2.03±1.17)h and AUC 0～24 were(127.23±32.41)ng/(h·ml)and(131.42±37.73)ng/(h·ml),respectively.The relative bioavailability of salbu_ tamol sulfate orally disintegrating tablet was(99.32±15.58)%.CONCLUSION:The results of two one-side tests suggests that salbutamol sulfate orally disintegrating tablet is bioequivalent to the commercial salbutamol tablet.