阿奇霉素口腔崩解片制备工艺与其质量标准.研究

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1、中文摘要质、含量均在标准范围内，本品稳定性较好。结论：本制剂质量稳定可控，使用方便，有利于扩大本品在临床的应用范围。关键词：鉴别；溶出度：有关物质；含量测定；稳定性荚文摘要PartoneStudiesontheTechnologyofAzithromycinorallydisintegratingtabletsABSTRACTAzithromycinisafifteen—memberedheterocycliccompound，whichhasgoodantibacterialactivityforextracell

2、ularandintracellularpathogen．Comparedwithadoptedmacrolide(erythromycin)，ithasthefollowingcharacteristic：1．Aziisactiveagainstthemicrobc+hatisinsensitivetomacrolideantibiotic．AndAzithromycinavailsagainstpneumoniachlamydia，pneumoniamycoplasmaandinfectionoftherespi

3、ratorycausedbyflora，withwhichtoofarbehindtocatchupmacrolide，B—lactam，cephalosporin．2．Azithromycinshowsnodrugtoleranceforstaphylococcusaureusproducinglactamase，moraxella，diplococcusgonorrhoeae．3．Itspreadswidelyintissues，butitsconcentrationsprominentlyvaryfromhig

4、htolowasfollows，themacrophageoflung，themucousmembraneofthebronchialtubes，genitals，lymphtissue．Azithromycinconcentrationsofinflammationregionareassixtimeshighasinthenon-inflammationregionandas50timeshighasholdbloodconcentrationsintissue．4．Thecourseoftreatmentiso

5、nlyaslongas3-5d，dosageonly250mg一500mg／d，convenienttotake，onceday．5．SideeffectonlyrepresentsE英文摘要gastrointestinaltractreaction，suchas，slightnausea，vomiting，diarrheaandSOon．Becauseofuntowardreaction，0．3％DeoplestopAzithromycin，whichislessthanerythromycinand3-lacta

6、m．Apharmaceuticaldosageform，orallydisintegratingtabletswhichcandisintegraterapidlyintheoralcavitywithoutdrinkingwater，hasattractedtheinterestsofmanyresearchers．Thistypeoftabletsofferstheadvantageoftakingwithease，disintegratingquickly,goodcomplianceofpatients．Bu

7、titsdevelopmentWaslimitedbecauseofitsunpleasanttasteofthedrugs．Objective：Toimprovethetasteofazithromycinandprepareazithromycinorallydisintegratingtablets．Method：Toimprovethetasteofazithromycin，wepreparedazithromycinmicrocapsulebyphaseseparation．ThebulkdrugWasmi

8、xedwithgelatinsolutionandthemicrocapsuleswerepreparedthroughcoacervation，settlement，CROSS。linkingsolidificationandsuspension．AlsotheorthogonalexperimentL9(34)designtooptimiz