Human pharmacokinetics and bioavailability of domestic salbutamol sulfate controlled release tablets

Objective:To study the pharmacokinetics and bioavailability of domestic and imported salbutamol sulfate controlled release(CR) tablets.Methods:18 healthy male volunteers were received oral single dose and multi doses of 7.2mg domestic and 8mg improted salbutamol sulfate CR tablets by an open randomized 2 way crossover design.The plasma salbutamol sulfate concentrations were determined by HPLC with fluorescence detection.Results:Data of single dose for domestic and imported products were given respectively as following:C max =(7.62±2.17) and (10.16±2.93)μg·L -1 ;T max =(4.83±1.76) and (4.67±1.61)h;AUC 0～t =(88.78±41.18) and (127.52±30.10)μg·h·L -1 .Data of multi doses for the 2 products were given respectively as following:C max =(10.94±2.38) and (11.67±3.24)μg·L -1 ;T max =(5.11±1.49) and (4.50±1.38)h;AUC ss =(88.07±18.33) and (89.80±20.35)μg·h·L -1 ;fluctuation degree=(76.69±43.89)% and (82.43±29.44)%.The relative bioavailability of domestic products at single dose and multiple doses were respectively(77.19±28.24)% and (111.81±24.59)%.Conclusion:The two products are of bioequvalence.