Relative Bioavailability of Salbutamol Sulfate Controlled-Release Tablets

The pharmacokinetics and relative bioavailability of two kinds of salbutamol sulfate controlled release tablets administrated orally by 18 healthy male volunteers were investigated,according to a randomized crossover design.The plasma concentration of salbutamol was determined by RP HPLC method with fluorescence detection.The pharmacokinetic parameters for the single oral dose of 8 mg salbutamol sulfate controlled release tablets were C max 10.12±3.93 and 10.18±2.76 ng/ml; T max 5.9±1.5 and 5.8±2.2 h; T 1/2 10.5±2.5 and 9.0±2.4 h; AUC 0→∞ 155.4±30.04 and 154.4±33.17 ng·h·ml -1 ,for testing and reference tablets,respectively.The relative bioavailability for the testing tablets was 102.1%±13.94%.For the multiple dosing,the salbutamol concentration peak trough ratio(PTR) was 1.84±0.68 and 1.64±0.42,the degree of fluctuation(DF) was 25.58%± 32.00 % and 21.04%±25.25%,respectively.The results of two one sided test showed that the two kinds of salbutamol sulfate controlled release tablets were bioequivalent.