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1、62MICROBIOLOGICALEXAMINATIONOFNONSTERILEPRODUCTS:TESTSFORSPECIFIEDMICROORGANISMS非无菌产品微生物限度检查:控制菌（USP38）1.INTRODUCTION导言Thetestsdescribedhereafterwillallowdeterminationoftheabsenceof,orlimitedoccurrenceof,specifiedmicroorganismsthatmaybedetectedundertheconditio
2、nsdescribed.控制菌检查法系用于在规定的试验条件下，检查供试品中是否存在特定的微生物。Thetestsaredesignedprimarilytodeterminewhetherasubstanceorpreparationcomplieswithanestablishedspecificationformicrobiologicalquality.Whenusedforsuchpurposes,followtheinstructionsgivenbelow,includingthenumberofsam
3、plestobetaken,andinterprettheresultsasstatedbelow.当本法用于检查非无菌制剂及其原辅料是否符合相应的微生物限度标准时,应按下列规定进行检验，,包括样品的取样量,结果的判断.Alternativemicrobiologicalprocedures,includingautomatedmethods,maybeused,providedthattheirequivalencetothePharmacopeialmethodhasbeendemonstrated.可以使用包
4、括自动化法在内的方法,需确认与药典方法的等同性.2.GENERALPROCEDURES通用规程ThepreparationofsamplesiscarriedoutasdescribedinMicrobiologicalExaminationofNonsterileProducts:MicrobialEnumerationTests61.供试品制备,同USP<61>Iftheproducttobeexaminedhasantimicrobialactivity,thisisinsofaraspossibleremo
5、vedorneutralizedasdescribedinMicrobiologicalExaminationofNonsterileProducts:MicrobialEnumerationTests61.若供试品有抗菌活性,应尽可能中和或去除,中和或去除的方法同USP<61>Ifsurface-activesubstancesareusedforsamplepreparation,theirabsenceoftoxicityformicroorganismsandtheircompatibilitywithan
6、yinactivatorsusedmustbedemonstratedasdescribedinMicrobiologicalExaminationofNonsterileProducts:MicrobialEnumerationTests61.若供试品制备过程中使用了表面活性剂,应确认其对微生物的无毒性以及与所用的中和剂/灭活剂的相容性，同USP<61>3.GROWTH-PROMOTINGANDINHIBITORYPROPERTIESOFTHEMEDIA,SUITABILITYOFTHETESTANDNEGATI
7、VECONTROLS培养基适用性检查，控制菌检查方法的适用性确认，阴性对照Theabilityofthetesttodetectmicroorganismsinthepresenceoftheproducttobetestedmustbeestablished.Suitabilitymustbeconfirmedifachangeintestingperformanceorachangeintheproductthatmayaffecttheoutcomeofthetestisintroduced.在有供试品存在的
8、情况下，所建立的方法应能检测微生物。若检测程序或产品发生变化可能影响检测结果时，控制菌检查方法应重新进行适用性试验。3.1.PreparationofTestStrains试验菌液的制备Usestandardizedstablesuspensionsofteststrainsasstatedbelow.Seed-lotculturemaintenancete
