The Study Of Dissolution Quality Standard Of Oral Solid Preparations And In Vitro-in Vivo Correlation Evaluation

Objective: 1.A preliminary study about seven kinds of oral solid preparations in vitro Dissolution quality standard of oral solid preparations preliminary study;2.Research the pharmacokinetics and bioequivalence studies on ibuprofen sustained release capsules,furosemide tablets and prazosin hydrochloride tablets,as well as appraisal it in vivo-in vitro correlation.Methods: 1.Using UV,HPLC and plate method on 7 kinds of oral solid dosage forms to determine the content;2.Online real-time determine the dissolution /release of 7 kinds of oral solid dosage formulation under two conditions of dissolution testing by FODT-601 instrument,using visual analysis,Weibull distrbution model fitting and f2 similartity factor method to compare the defferences of dissoluton curves of 7 kinds of oral solid dosage formulation under different conditions of dissolution,and evaluate the similarity of dissoluton curves between test preparation and reference preparation;3.Using HPLC method to determined plasma concentrations of animals in a single dose at different times about ibuprofen sustained release capsules,furosemide tablets and prazosin hydrochloride tablets,calculated pharmacokinetic program pharmacokinetic parameters by 3p97,examine the relative bioavailability,and evaluate bioequivalence between test preparation and reference preparation;4.Using Wagner-Nelson method to calculate In vivo absorption fractiont F in t time,with F as the dependent variable,with the corresponding time in vitro dissolution cumulative percentage Fd as independent variables,using least squares linear regression determine in vitro-in vivo correlation equation F=a X+b and Goodness of fit R2,determine whether a significant correlation.Results: 1.Determination of 7 kinds of oral solid dosage results were satisfied Ch.PⅡ(2010 edition)states that all test preparation and reference preparation content difference did not exceed5%;2.There are differences on drug dissolution profile and the dissolution behavior between seven kinds of oral solid formulations of the same drug with different drugs and different manufacturers between changes from changes same dissolution test conditions.Among them,the ibuprofen sustained release capsules release a test preparation and reference curves than similar preparations,more consistent dissolution behavior,furosemide tablets dissolution profile test preparation four dissimilar than the reference formulation,dissolution behavior inconsistent,hydrochloric acid prazosin tablets dissolution profile test preparation and reference a dissimilar than the preparation,dissolution behavior quite different;3.The established HPLC method is rapid,sensitive,accurate,and ibuprofen sustained release capsules for a test preparation and prazosin hydrochloride tablets test preparation a reference formulation of its bioequivalent,furosemide tablets 4 test preparation and reference preparation is not bioequivalence;4.Ibuprofen sustained release capsules,furosemide tablets and prazosin hydrochloride tablets reference preparation and test preparation have better in vitro – in vivo correlation.Conclusion: This results maybe provide theoretical and experimental evidence for normative vitro Dissolution quality standard of oral solid preparations about seven kinds of oral solid preparations as well as the in vivo and in vitro correlation of ibuprofen sustained release capsules,furosemide tablets and prazosin hydrochloride tablets in some extent.