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复方rgna-mh缓释片的研制-preparation of compound rgna - mh sustained release tablets
ABSTRACTInthisthesis,thesustained-releasematerialisHPMCK100M.ItisgranulatedbythewetprocessingandthecoreofMHsustained-releasetabletsaremadebythetechnicsofpressing.RGNaasordinarycoatingmaterialisaddedinthecoatingsolutionandthencoatthecoreofMHsustained-releasetabletsbytheordinaryfilmcoatingtechnologytofabricateRGNafast-releaselayer.Thepreparationmethods,influencingfactorsofMHsustained-releasetabletscoreandRGNafast-releaselayer,stabilityoffinishedproductsandsoonareinverstigatedcomprehensivelyanddeeply.Theresultsshowthatthepropertyofthesustained-releasetabletsisstable,thepartofthefast-releasereleasesrapidlyandthepartofthesustained-releasereleasesstableandlasting.TheHPLCdeterminationmethodswereestablishedseparatelyforMHandRGNacontent,therelease(dissolution),therelatedsubstancesandcontentuniformity.Theresultsshowthattherepeatabilityisgood,theresultisaccurate,itisnotaffectedbyexcipientsanditisfitforinvitrocontrol.Beforetheformulationstudy,regardthematerialsproperties,contentofRGNaandMH,relatedsubstancesandsoonasthequalityindex.WeresearchthecompatibilitybetweenmainmedicineRGNaandMH,amongRGNa,MHandrelevantexcipients.ResultsshowthatcompatibilitybetweenRGNaandMHisgoodandtheexcipientscanbeusedinthestudy.Regardingreleaserateasjudgingtheprinciple,weresearchthetypesandspecificationsofsustained-releasematrixmaterials,thetypesandconcentrationofadhesiveagents,theamountoflubricant,themethodofgranulation,theaddingwaysofHPMCandthepressureoftablets.Onthebasisoftheresearchresults,weadoptedtheorthogonaltestL9(34)toscreentheformulation.Thesustained-releasetabletscorewaspreparedwithHPMCK100MasbasicmatrixmaterialsofMH,microcrystallinecelluloseasfillingagent,magnesiumstearateaslubricant,5%HPMCE5and70%ethanolasadhensivemateria1.Thecorereleasewellanditistotaluptotherequirementofreleasingfor12hours.Experimentsshowthatithasobvioussustained-releasecharacteristicinvitro,thereleasedruleaccordswithHiguchiequationandthecurveofreleaseandsquarerootoftimeisnearlylinear.ThecoreofMHsustained-releasetabletsar
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