ftir在药品控制菌鉴定中的应用

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1、中国药品生物制品检定所硕士学位论文AbstractThepurposeofmicrobiallimittestismonitoringthecontaminationofmicroorganisms,whichisoneoftheimportantindexesofdrugqualityandsafetyevaluation.Themonitoringofmicroorganismscontaminationshouldjudgewhetherpathogenexistsaswellasidentify

2、ingwhetherthedrugwascontaminatedbymicroorganisms.Theroutineidentificationandenumerationtestsoflargenumbersofbacteriaincomplexmicrobialconsortiatodetectpathogeninpharmacopeiaarebasedontraditionalbiochemicalanalysis,andthesetestsareexpensiveandtimeconsumin

3、g.Althoughthetestsarelargelyapplied,theyarenotveryaccurateforsomecloselyrelatedspecies.Themoleculartechniqueswhichareclaimedtoprovidereproducibleanddiscriminatoryresults,requireconsiderabletechnicalexpertiseandarelaborious,slowandexpensive.Therefore,they

4、aredeemedunattractiveforroutineapplicationinlaboratories.Fouriertransforminfraredspectroscopy(FTIR)isanapproachbasedonopticalspectroscopictechniques.Itcharacterizesthechemicalcompositionofverycomplexbiologicalsystemssuchasmicroorganismsandprovideshighlys

5、pecificspectroscopicfingerprints.Thistechniquerepresentsananalytical,non-destructiveanddynamicmethodtoinvestigateapopulationofwholecellswithonlylittlebiomass.Itpermitsidentificationandcharacterizationofmicrobialcellsatbothspeciesandsub-specieslevels.Inth

6、isstudy,FT–IRspectroscopyhasbeenusedtomonitorthepathogeninthepharmaceuticalsystemrapidlyforthefirsttime.Themaincontentofthisthesisincludestwopartsasfollow:1.Theexperimentalmethodologyandinspectionofinfluencingfactorsandestablishmentofstandardoperationpro

7、cess(SOP)ThroughtheinspectionofmicrobialFTIRspectraunderdifferentculture2中国药品生物制品检定所硕士学位论文conditionanddifferentoperationmode,itindicatesthatdifferentnutritionelements,culturetemperatureandculturetime,differentoperationandsamplepreparationmethodscancaused

8、ifferencesinFTIRspectraeach.InordertoensurethereproducibilityofFTIRspectra,uniformcultureconditionandstandardoperationprocessarenecessary.SOPisthepreconditiontoguaranteetheeffectivenessandtransitivityofFTIRspectralibraries