Bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the time-concentration curves of single dose of ambroxol hydrochloride orally integrating tablets in healthy volunteers and to evaluate its bioequivalence.METHODS:A single oral dose of 90mg ambroxol hydrochloride orally dissolving tablets and 90 mg ambroxol hydrochloride tablets were given to 18 healthy volunteers by a randomized crossover design.The concentrations of ambroxol hydrochloride in plasma were determined by HPLC.RESULTS:The main pharmacokinetic parameters of the test and references preparations of ambroxol hydrochloride were as followsCmax were(169.58?39.43)ng?mL-1 and(170.28?43.26)ng?mL-1;tmax were(1.6?0.5)h and(2.2?0.6)h;t1/2 were(6.77?2.04)h and(6.50?1.27)h;AUC0～24 were(1 131.26?289.36)ng?h?mL-1 and(1 191.54?270.17)ng?h?mL-1;AUC0～∞ were(1 215.27?306.56)ng?h?mL-1 and(1 281.44?291.51)ng?h?mL-1,respectively.The relative bioavailability of the test preparation was(95.5?15.6)%.CONCLUSION:The result demonstrated that the two preparatioins were bioequivalent in absorption degree,suggesting the rapid release characteristics of the preparation.