复方布洛肾素那敏片的制备及释放度一致性研究

[e-mail][e-mail]255086。。f2＞50。。Ｒ944．4A2095－5375201504－0219－005StudiesonpreparationofAllergyandCongestionＲeliefandconsistencyofreleaserateZHENGZhong-huiZHANGDai-mingYANGAi-rongTENGHai-fengSUIShuang-mingPANXi-haiShandongXinhuaPharmaceuticalLimitedCompanyZibo255086ChinaAbstractObjectiveToprepareAllergyandCongestionＲeliefandcomparetheoriginalcommercialproductAdvilandas－preparedproductswithconsistencyofreleaserate．Atthesametimetoensurethattheas－preparedproductsareconsistentwithreleaserateofAdvil．MethodsAllergyandCongestionＲeliefwaspreparedbythewetgranulationdryingbyfluidizedbedanddetectingthereleaseratebyHPLC．ＲesultsComparedtheas－preparedproductsofdissolutioncurvetoAdvilinfourdissolutionmediasthedateoff2＞50．ConclusionThepreparationprocesswassimpleandthesimilarre-leaseratecanensureconsistencyinthequalityofself－madeproductsandAdvil．KeywordsAllergyandCongestionＲeliefWetgranulationＲeleaserate20105FDA、、。、。。、2831。。2～45～8。ppc。2。。11．1FW100HLSH2－6WK60DPLIISYH－20C＆C800JGB20－AD。1．2·912··JournalofPharmaceuticalＲesearch2015Vol．34No．4DOI:10.13506/j.cnki.jpr.2015.04.01114039140107PEH－121223PH1022394JＲS320103410620140301201402252014033520131202。AdvilＲ12615140701、140702、140703。22．12．1．1。55～60℃。。2.1.2、、、、、、0.510d、、、、、、。、、、、、、。2.1.32.1.3.1、《》2010ⅩCpH7.2、0.1mol·L－1、pH=6.5、900mL50rpm10、15、20、30、45min5mL、0.45μm1mL0.22mg。－0.01mol·L－140∶602mL·min－1215nm。20μL。。80%。2.1.3.2、《》2010ⅩCpH7.2、0.lmol·L－1、pH=6.5、900mL50rpm10、15、20、30、45min5mL、0.45μm1mL11.1μg4.4μg。－0.1%pH3.020∶80A－1.0g23g1000mLpH3.060∶40B11.5mL·min－1215nm。20μL。。80%。1minA%V/VB%V/V0～10100010～20100→750→2520～50752550～5175→025→10051～60010060～610→100100→061～7010002.1.4。WHOBCS31BA25%～59%。。、、。。·022··JournalofPharmaceuticalＲesearch2015Vol．34No．415min85%2～5。。20.1mol·L－13%10min15min20min30min45min90．893．395．496．897．180．488．795．898．599．611．715．116．819．119．990．893．395．496．897．192．092．396．296．898．211．414．816．318．919．73pH=7.23%10min15min20min30min45min90．696．698．498．599．477．185．188．589．392．486．793．898．699．099．491．297．398．599．099．977．886．389．490．193．590．696．698．498．599．44pH=6.53%10min15min20min30min45min87．890．493．694．896．980．986．588．990．593．571．987．490．393．094．988．591．394．495．697．981．387．489．691．794．872．688．390．293．194．453%10min15min20min30min45min78．890．193．395．097．975．087．090．693．595．416．920．221．424．025．779．490．594．995．898．976．788．391．294．195．917．521．321．325．129．12.1.5、、、、、、。3min2min2h1.0%。、、A、B、CpH7.2、pH6.5、0.1mol·L－1、f2L934。67。1000。6AgBgCg1100．21．62120．5231412．47f2ABCpH7．2pH6．50．1mol·L－1111144．245．650．153．048．23212255．447．849．650．450．80313338．345．647．754．446．50421250．752．148．551．350．65522360．157．966．559．260．93623150．339．443．852．146．40731350．943．747．949．948．10832157．742．141．053．148．48933243．946．735．940．941．85K1145．53146．98143．11K2157．98160．21143．30K3138．43134．75155．538A2B2C3。51000。8g200410145110122．40．566201A665000804552.2、100、、、、、、、HLSH26800rpm1000rpm3min。WK6024DPL－II·122··JournalofPharmaceuticalＲesearch2015Vol．34No．445℃20Hz2h1.0%。C＆C80010mm7kg。0.490g5%。JGB45℃3%～4%。3140701、140702、140703。2.32.3.1—f2。、。。f2FDASFDA。f2。f2。f2=50×log1+1÷n∑nt=1Ｒt－Tt[]2－0．5{}×100f2—Ｒt—tTt—tn—2.3.2“2.1.3.1”49。9%10152030456090120f2pH7．2pH6．50．1mol·L－1Advil90．696．698．498．599．414070185．792．497．197．297．114070286．593．298．198．999．014070385．992．897．897．998．7Advil72．688．390．293．194．414070171．286．191．692．092．114070271．586．692．092．393．214070371．887．290．192．994．7Advil11．414．816．318．919．720．723．124．1－14070114．815．618．719．722．324．326．826．577．1314070212．915．116．719．220．321．923．924．894．3014070313．215．517．218．821．323．625．426．184．68Advil17．521．321．325．129．129．930．430．1－14070116．920．221．424．125．627．829．530．586．3214070216．820．021．123．925．527．529．830．385．3714070317．120．821．924．325．828．129．930．887．95pH7.2、pH6.515min85%f2。33Advilf250。1WongJWisemanLAl－MamoonSetal．Majordegra-dationproductidentifiedinseveralpharmaceuticalformu-lationsagainstthecommoncoldJ．AnalChem200678227891－7895．2El－BolkinyNMHanaSEl－HenaweeMMetal．Deriv-ativespectrophotometricdeterminationofchlorphenira-minemaleateincombinationwithetilefrineresinateordextromethorphanhydrobromideJ．EgyptJPharmSci1992331－231－42．3TuszynskaEPodolskaMKwuatkowska－PuchniarzBetal．NewmethodsfordeterminationofactivecompoundspresentinmulticomponentantihistaminicpharmaceuticalsJ．ActaPolPharm1994514317－323．4BararyMHWahbiAM．Spectrophotometricdeterminationofchlorpheniraminemaleateandchlorphenoxaminehydro-chlorideeachinthepresenceofcaffeineasbinarymix-turesJ．DrugDevIndPharm1991173457－461．5WongJWisemanLAl－MamoonSetal．Majordegra-dationproductidentifiedinseveralpharmaceuticalformu-lationsagainstthecommoncoldJ．AnalChem200678227891－7895．228·222··JournalofPharmaceuticalＲesearch2015Vol．34No．420BennettNCGardinerＲAHooperJDetal．MolecularcellbiologyofandrogenreceptorsignallingJ．IntJBio-chemCellBiol2010426813－827．21WangQLiWLiuXSetal．Ahierarchicalnetworkoftranscriptionfactorsgovernsandrogenreceptor－depend-entprostatecancergrowthJ．MolCell2007273380－392．22ZhangZChangCWGohWLetal．CENTDISTdiscover-yofco－associatedfactorsbymotifdistributionJ．Nu-cleicAcidsＲes201139WebServerissu