Healthy Human Bioequivalence of Sinomenone Hydrochloride Enteric-Coated Tablets

A method was established to determine sinomenone hydrochloride in human plasma by HPLCthe pharmacokinetics of sinomenone hydrochloride enteric-coated tablets in healthy volunteers were investigated,and bioequivalence and the human body relative bioavailability of which were evaluated.18 male healthy volunteers were randomized to take a single crossover oral dose of test tablets or reference tablets 80mg.The concentration of sinomenone hydrochloride in plasma at different time within 36h was determined by HPLC.The relative bioavailability was calculated and the bioequivalence of test tablets and reference tablets were evaluated by BAPP pharmacokinetic program. The sinomenone hydrochloride main pharmacokinetic parameters of test tablets and reference tablets were respectively as follows:t_(max):(2.36±0.64)h and(2.56±0.62)h,C_(max):(838.05±145.78) ng·mL~(-1) and(819.46±105.77)ng ? mL~(-1),t_(1/2):(11.29±1.95) h and(10.10±2.75 )h, AUC_((0→36h)):(5850.39±1805.83)ng ? h ? rnL~(-1) and(6134.85±1862.25)ng ? h ? rnL~(-1).The elative bioavailability of two tablets was(101.1±36.1%).The established method is sensitive,accurate with reliable results.The results of statistics show that test tablets are bioequivalent to the reference tablets.