Pharmacokinetics of Complex Roxithromycin Tablets in Healthy Volunteers

OBJECTIVE To study the pharmacokinetics of complex roxithromycin tablets in healthy volunteers.METHODS 48 Healthy volunteers were administrated randomly and parallelly with complex roxithromycin tablets(I),300 mg roxithromycin tablets(Ⅱ),60 mg ambroxol hydrochloride tablets(III) and combined roxithromycin tablets and ambroxol hydrochloride tablets(Ⅳ),respectively.The concentrations of roxithromycin or ambroxol in plasma were determined by LC-MS/MS.The pharmacokinetic parameters were calculated with DAS2.1 and evaluated by one-factor analysis of variance.RESULTS Compared with group Ⅳ,the pharmacokinetic parameters of roxithromycin and ambroxol in group Ⅰ showed no significant difference.However,compared with group Ⅱ,the pharmacokinetic parameters of roxithromycin of group Ⅰ including AUC,CLz/F,Vz/F and ρmax,displayed significant difference.Compared with group Ⅲ,the pharmacokinetic parameters of ambroxol of group Ⅰ including AUC,MRT0-t,CLz/F and Vz/F revealed significant difference.CONCLUSION The pharmacokinetic parameters of roxithromycin and ambroxol had no significant difference between groupⅠ and group Ⅳ,while their pharmacokinetic parameters had significant difference between group Ⅰ and group Ⅱ/ group Ⅲ.