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1、DEVELOPMENTOFTHEPRODUCT(STUDYOFPREFORMULATIONOFTHEPRODUCT)OBJECTIVEToObtaintabletsofVitaminBcomplextabletsthatcomplieswithNationalstandard.SELECTIONOFMATERIALSelectionofActiveingredientleThiamineHydrochlorideManufacturedinHubeiHuazhongPharmaceuticalCo.,Ltd.andcomplieswithBritishPharmaco
2、poeia2007.Thiaminehydrochlorideisawhiteoralmostwhite,crystallinepowder,freelysolubleinwater,solubleinglycerol,slightlysolubleinalcohol.2.PyridoxineHydrochlorideManufacturedinZhejiangTianxinPharmaceuticalCo.,Ltd.andcomplieswithBritishPharmacopoeia2007.PyridoxineHydrochlorideisAwhiteoralm
3、ostwhite,crystallinepowder,freelysolubleinwater,slightlysolubleinalcohol.Itmeltsatabout205°C，withdecomposition.3.CyanocobalaminManufacturedinSichuanPharmaceuticalCo.,Ltd.andcomplieswithBritishPharmacopoeia2007.CyanocobalaminisAdark-red,crystallinepowderordark-redcrystals,sparinglysolubl
4、einwaterandinalcohol,practicallyinsolubleinacetone.Theanhydroussubstanceisveryhygroscopic.SelectionofexcipientsBelowarereviewedintheformulaselection:Maizestarch,Sucrose,Dextrin,Hipromellose,MagnesiumStearateandMicrocristallineCellulose.AlltheingredientscomplieswithBporUSPstandards.Selec
5、tionofcoatingmaterialThiaminehydrochloride,PyridoxineHydrochlorideandCyanocobalaminarehygroscopic,soweselectthefilmcoatingmaterialtoprotecttheactiveingredients.CoatingthetabletsusethefilmcoatingpowdermanufacturedbyZhejiangXinhuaPharmaceuticalCo.,Ltd.andTianjinILEPharmaceuticalMaterialsC
6、o.,Ltd.Coatingasnormalaccordingtothefilm-coatingtechnicsCoatingsolution1:manufacturedbyZhejiangXinhua,addintoPurifiedwater,agitate45minutestoprepare8%coatingsolution.Coatingsolution2:manufacturedbyTianjinILE,addintoPurifiedwater,agitate45minutestoprepare12%coatingsolution.Test:Heat-resi
7、stancetestofcoatingfilm:tranfertabletscoatedbysolution1andsolution2respectivelyinto80ovenfor3hours,takeoutandobservethefilmchangequickly.Moistureproof,waterprooftest.Separateputthetablets20tabletscoatedbythetwocoatingsolutionunderthecircumstancesof25°CRH75%and25°CRH92.5%,sample
