阿奇霉素多晶型现象与结晶过程.研究

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1、ABSTRACTsupersolubilityofAzithromycininthewater-ethanolmixtureofdifferentvolumeratioat283．2Kto303．2K．Thegeneralsolubilitymodelwasconstructedbasedoncharacterofsalvationandevaluatedbyerroranalysis．Thekineticmodelsconcerningthenucleationandcrystalgrowingw

2、ereestablishedbasedonthepopulationbalanceequation，nucleationandgrowthkineticsweremeasuredaccordingtosolutemassconservationlawandtheunsteadystatemethod．TheequationsofnucleationandgrowthrateofAzithromycinWasdeterminedbynon-linearregressionanalysis．Themod

3、elofgrowingunrelatedtoparticlesizedescribedtheprocessofcrystalgrowth．Themodelparametersindicatedthatthehi曲correlationexistedbetweengrowthrateandsupersaturationwhichWasthekeytoobtainperfectcrystals．Atlast，theeffectoftheinitialconcentrationofcrystalmothe

4、rliquid，thecrystallizationtemperature，theagitationspeed,theadditionrateofantisolventagentandthesolutionpHonCSD，crystalhabitandpercentageoftargetproductweresystematicallyinvestigatedbytheorthogonalexperientialmethodandanewcrystallizationmethodWasdiscove

5、red．Thenewcrystallizationmethodsolvedtheproblemofcontrolcrystalshape，crystalhabitandcrystalsize．Finally,anewcrystallizationprocesssystemforAzithromycinethanolsolvateproductionWasestablished．ThestudyprovidedtheoreticalbasisforAzithromycinpolymorphismpro

6、ductionandsetademonstrationroleforAntibioticpolymorphismproduction．Keywords：Azithromycin；polymorphism：dissolution；crystallizationthermodynamics；crystallizationkinetics：ProcesscontrolIV硕士学位论文目录摘要⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯IABSTRACT⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯

7、⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯III第一章绪论⋯⋯⋯⋯：⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯．11．1阿奇霉素概述⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯11．1．1阿奇霉素结构及性质⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯11．1．2阿奇霉素药理毒理研究⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯l1．1．3阿奇霉素临床应用⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯．31．1．4阿奇霉素合成方法⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯一61．2多晶型现象⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯

8、⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯61．3多晶型对药物的影响⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯71．3．1多晶型对药物理化稳定性的影响⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯．71．3．2多晶型对药物溶出度的影响⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯．71．3．3多晶型对药物生物利用度的影响⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯一81．4阿奇霉素多晶型研究现状⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯．81．5研究目的及主要内容⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯⋯。91．5．1研究的目