Pharmacokinetics and Bioequivalence of Matrine Tablets and Matrine Capsules in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE: To compare the pharmacokinetic parameters between matrine tablets and matrine capsules in healthy volunteers and evaluate the bioequivalence of the two formulations.METHODS: 18 healthy volunteers were assigned to receive matrine tablets(test formulation,600mg) and matrine capsule(reference formulation) respectively q.d on empty stomach.The plasma concentrations of oxymatrine before and after medication were determined by HPLC and the pharmacokinetic parameters(calculated by oxymatrine) were calculated.RESULTS:The pharmacokinetic parameters of matrine tablets vs.matrine capsules in healthy volunteers were as follows:t1/2:(1.51?0.62)h vs.(1.53?0.54)h;Tmax:(1.35?0.13) hvs.(1.29?0.13)h;Cmax:(730.86?101.13)ng?mL-1 vs.(729.58?74.35)ng?mL-1;AUC0～8:(2 579.1?244.4)ng?h? mL-1 vs.(2 505.7?223.5)ng?h?mL-1;AUC0～∞:(2 754.1?331.8)ng?h?mL-1 vs.(2 659.4?253.5)ng?h?mL-1.The relative bioavailability of matrine tablets(calculated by oxymatrine) was(103.7?13.3)%.CONCLUSION: There are no significant differences between matrine tablets and matrine capsule in main pharmacokinetic parameters,which were in conformity with the presumption of bioequivalence between different individuals,different periods or different dosage forms.The two formulations are bioequivalent.