USP 61 微生物限度检测——计数法

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1、<61>MICROBIOLOGICALEXAMINATIONOFNONSTERILEPRODUCTS:MICROBIALENUMERATIONTESTS非无菌产品微生物限度检查：微生物计数法1.INTRODUCTION导言Thetestsdescribedhereafterwillallowquantitativeenumerationofmesophilicbacteriaandfungithatmaygrowunderaerobicconditions.微生物计数法系用于能在有氧条件下生长的嗜温细菌和霉菌的定

2、量计数。Thetestsaredesignedprimarilytodeterminewhetherasubstanceorpreparationcomplieswithanestablishedspecificationformicrobiologicalquality.Whenusedforsuchpurposes,followtheinstructionsgivenbelow,includingthenumberofsamplestobetaken,andinterprettheresultsasstate

3、dbelow.当本法用于检查非无菌制剂及其原、辅料等是否符合相应的微生物限度标准时，应按照下述规定进行检验，包括样品的取样量，结果的判断。Themethodsarenotapplicabletoproductscontainingviablemicroorganismsasactiveingredients.本法不适用于活菌制剂的检查。Alternativemicrobiologicalprocedures,includingautomatedmethods,maybeused,providedthattheir

4、equivalencetothePharmacopeialmethodhasbeendemonstrated.可使用包括自动化法在内的替代方法，需确认其与药典方法的等同性。2.GENERALPROCEDURES通用规程Carryoutthedeterminationunderconditionsdesignedtoavoidextrinsicmicrobialcontaminationoftheproducttobeexamined.Theprecautionstakentoavoidcontaminationm

5、ustbesuchthattheydonotaffectanymicroorganismsthataretoberevealedinthetest.微生物计数环境应能防止外来微生物对供试品的污染。防止污染的措施不能影响供试品中微生物的检出。备注：检验全过程必须严格遵守无菌操作，防止再污染。单向气流区域、工作台面及环境应定期进行监测。Iftheproducttobeexaminedhasantimicrobialactivity,thisis,insofaraspossible,removedorneutraliz

6、ed.Ifinactivatorsareusedforthispurpose,theirefficacyandtheirabsenceoftoxicityformicroorganismsmustbedemonstrated.如果供试品有抗菌活性，应尽可能去除或中和。若使用了中和剂或灭活剂，需确认其有效性及对微生物无毒性。Ifsurface-activesubstancesareusedforsamplepreparation,theirabsenceoftoxicityformicroorganismsandt

7、heircompatibilitywithanyinactivatorsusedmustbedemonstrated.供试品制备过程中若使用了表面活性剂，需确认其对微生物无毒性以及与所使用的中和剂或灭活剂的相容性。3.ENUMERATIONMETHODS计数方法UsetheMembraneFiltrationmethodoroneofthePlate-CountMethods,asdirected.TheMost-Probable-Number(MPN)Methodisgenerallytheleastaccur

8、atemethodformicrobialcounts;however,forcertainproductgroupswithverylowbioburden,itmaybethemostappropriatemethod.计数方法包括薄膜过滤法、平皿法和最可能数法（Most-Probable-Number简称MPN)。MPN法用于微生物计数时精确度最差，但用于微生物污染