双嘧达莫缓释滴丸的研制

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1、重庆医科大学硕士研究生学位论文TheSTUDIESOnTheSUSTAINED．RELEASEDRoPPINGPILLSofDIPYRIDAMOLEABSTRACTDroppingpillsisasoliddispersionwithsolidorliquiddrugmeltinmatrix，andbeingdroppedintothecoolingagentthencontractintopillwhichhastheadvantagesofalargesurfacearea，lowgastrointestinalirritation，highbioavailabilityandp

2、roductivity．Inthisthesis，wepreparedsustained-releasedroppingpillsusingdipyridamole(DIP)asthemodeldrug．Westudiedtheformulaandformingtechnologyaccordingtotheresultsofthepreliminarytest；theorthogonalexperimentwascarriedouttoselecttheformationaccordingtotherateofaccretio，qualificationofcircular，the

3、RSDofweight，andoptimalformulabyhardnessanddrugrelease．Thequalityofthesustained—releasedroppingpillsWasevaluated，andstudyonpharmacokineticsWascarriedoutinanimalexperiments．First，methodwasestablishedtodetermineDIPbyultravioletspectrophotometrywhichwasaccurate，sensitiveandcouldbeusedindetermiantio

4、nofcontentanddrugrelease．TheoptimumformulationforDIPdroppingpillswasPEG20000(39)：PEG6000(69)：SA(5．79)：EudragitL100(O．49)：GMS(2．99)：4重庆医科大学硕士研究生学位论文DIP(29)．Drugreleasedfromthedroppingpillscouldbesustainedfor12hinvitroandtherewasnoobviousdifferencebetweenreleasingbehaviorinmediumwithpHI．2andpH6．8

5、．ThefriabilitywasO．61％士O．07％．Investigationondrugreleasewascardedoutinvitroandthecurvefittingmethodwasusedtofindthedrugreleaseequation．TheDIPreleasebehaviorfromdroppingpillsfollowedthezero—orderkineticsbetweenO～2handfirst．orderkineticsbetween3～12h．Qualityofthesustained-releasedroppingpillsWaseva

6、luatedbyDSCandIRcombinedwithmicroscope．TheresultsshowedthatDIPwasofamorphousstateinmatrixandformedsoliddispersion．Resultsofthestabilityexperimentsindicatedthatthepillscouldbekeptstableat(40土2)℃，RH(75士5)％for6months．AnHPLCmethodfordeterminationofDIPinrabbitsplasmawasestablished．Doublecyclecrossov

7、erwithsingleoraldosewasperformedtoinvestigatepharmacokineticsandrelativebioavailabilityinrabbitsusingcommontabletsascontr01．Thedatawereprocessedusing3p87pharmacokineticprogram．Significantdeviationinbioavailabilitywasobservedbetwee