Study on In Vitro-In Vivo Correlation of Naftopidil Sustained-release Capsules / 中国药房

ABSTRACT

OBJECTIVE:To study the in vitro-in vivo correlation of sustained-release naftopidil capsule,review the rationality of the designed dissolution conditions METHODS:Artificial gastric juice was selected as the dissolution medium,the dissolution rate of the two naftopidil sustained-release capsules were studied;the 3p97 pharmacokinetic program was used to characterize the in vivo course of the sustained-release capsules after giving dogs a oral single dose of 200mg,after this,the percentage absorbed at different time were calculated The input functions were obtained by using deconvolution technique Then the correlation coefficients of the calibration graph by plotting the dissolution rate to the percentage absorbed or the input functions were calculated The in vitro-in vivo correlations of sustained-release naftopidil capsules were studied by comparing the correlation coefficients calculated to the critical correlation coefficients RESULTS:The correlation coefficients calculated by the two methods were both more than the critical coefficients,the in vitro-in vivo correlations of the two sustained-release naftopidil capsules were good CONCLUSION:The two methods mentioned in this paper to study the in vitro-in vivo correlation were simple and reliable,the results of this study were very useful in the rapid formulation screening,the designing of rational dissolution rate conditions,and the providing theory basic of evaluation of the naftopidil sustained-release capsules