穿山龙注射液制备工艺及质量评价的研究

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1、ResearchonPreparationandQualityRe-evaluationofRhizomaDioscoreaeNipponicaeInjectionSpeciality:PharmacyofTraditionalChineseMedicineAuthor:SuMingTutor:ProfessorTIANJing-zhenAbstractObjectiveToexplorethereasonsfortheirritationoftheDioscoreainjection,andop

2、timizethepreparationoftheDioscoreinjection,reducingitsirritatingandimprovethecontentofitsactiveingredients,andtoestablishthefingerprintofmedicinalherbsandpreparationsofDioscoreapreparationsforqualitycontrol.Methods:Muscleirritationtestwasusedasanindic

3、atortoinvestigatethecauseofDioscoreainjectionirritating;Byorthogonaltest,thewaterextractionofDioscoreaisscreened;UsingMacroporousresinrefinedwater-solublesaponinsofDioscorea,tofindthebestpreparation,determinedbytherefinedextractpartofthewater-solubles

4、aponins;HPLCmethodwasusedtoestablishwater-solublesaponincontentofDioscorea,fingerprintdeterminationmethodsofmedicinalherbsandpreparationsResultsThetannin,theactiveingredientitselfandPHoftheDioscoreainjectionarethereasonsforiteirritating.Theextractiona

5、ndrefiningparametersofthepreparationwaeestablished.TodeveloptheCentralPlainsdiosgenin,Dioscoreawater-solublesaponinandmethylprotodioscinthedeterminationofstandardsHPLCfingerprintofmedicinalherbsandtheirpreparationoftheDioscoreawaeestablished.-4-Conclu

6、sionAfterthepreparationprocesstoimprovewater-solubleDioscoreadiosgenin,saponinsfromtheCentralPlainsandthetotalcontentofmethylprotodioscinofmorethan60%.Theestablishmentofwater-solublesaponinsmeasuredbythestandardandmedicinalherbsandpreparationsbyhighp

7、erformanceliquidfingerprintreproducibility,precision,goodstability,goodfingerprintsimilarity,improvementofDioscoreainjectionofthequalitycontrolmethod.KeywordsDioscoreainjection;Irritating;Extractiontechnology;Purificationtechnology;Fingerprint.目录引言.

8、............................................................1第一部分课题研究思路.............................................3第二部分穿山龙注射液刺激性的初步研究..............................41.穿山龙注射液的制备...........................................41.1仪器与材料.............