中药口腔崩解片制剂学与其崩解评价方法学研究

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1、重庆医科大学硕士研究生学位论文了不同崩解原理的ODT相应的体外崩解时限评价方法。改进和优化了El腔崩解片的基本处方，使其无沙砾感和干燥感、崩解迅速、硬度合格、工艺简单、成本低适合于工业化生产。首次研制了红参提取物口腔崩解片，对其口腔内和体外质量评价进行了研究，证实红参提取物口腔崩解片在El腔内有良好的口感，能够快速崩解，质量符合要求。关键词：红参，评价方法，体内外相关性，玉米淀粉，口腔崩解片重庆医科大学硕士研究生学位论文STUDIESONPHARMACEUTICSANDEVALUATIONoFCHINESETRADITIONALMEDICINEO

2、RALLyDISINTEGRATINGTABLETSABSTRACTOrallydisintegratingtablets(ODT)whichcandisintegraterapidly(

3、quickly、quicklyabsorbing、highbioavailability、fittoemergency、lowsideeffectandSOon．SOitdevelopsquicklybothhereandabroadAccordingtotheresearch，50％patientfeelunadvisabetoprepraration，30％patientfeeldifficultytoswallowabouttrocheandcapsule，especiallyamongolderandenfant，whichbringon

4、damnifing100billiondollarsinAmerica．Asourcountryenteringintotheolderage，thedemandofODTincrease，SoODThasgoodmarketoutlook．ThereisextensiveuseofODTinWesternmedicinebutjustthebeginninginChinesetraditionalmedicine．Someproblemssuchasgrittiness，bitterness，hardness，assessmentinvitro

5、disintegtation，quickly6重庆医科大学硕士研究生学位论文disintegratingandmanufactureneedtobesolved．Beacauseofcomplicatedingredientandsignificantdose，thetechnicofODTbecomesdifficultyinChinesetraditionalmedicineTosolvesomeproblemlistingabove，westudyChinesetraditionalmedicineODTfromthreefacetsasf

6、ollow：(1)studytheevaluationmethodofinvitrodisintegration，(2)studythepharmaceuticsof0DT，(3)PrepareandestimatetheRedGinsengextractionODT,whichsupplythemethodofpreparationandevaluationofChinesetraditionalmedicineODTThefirstpartofisabouttheestablishmentofevaluationmethodofODTinvi

7、trodisintegration．WeusefivemethodstomeasurethedisintegrationtimeofthreetypesODT(suchastodisintegrateintosmallgranulesfacingtosaliva，todissolveassoonasquicklyandgraduallyfacingtosaliva，toresorbgraduallyfromlayertolayerinthecavity)andsawabouttheinfluentialfactorofeachmethod．The

8、correlationofdisintegrationtimeinvivoandinvitro，theresolution，therep