微生物计数检查法usp61中英对照版

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1、非无菌产品微生物学检查：微生物计数检查法USP61中英对照版<61>MICROBIOLOGICALEXAMINATIONOFNONSTERILEPRODUCTS:MICROBIALENUMENRATIONTESTS非无菌产品微生物学检查：微生物计数检查法INTRODUCTION导言Thetestsdescribedhereafterwillallowquantitativeenumerationofmesophilicbacteriaandfungithatmaygrowunderaerobicconditions.以下所描述的这些检测将使得对在有氧的条件

2、下生长的嗜温性细菌和真菌进行定量计数成为可能。Thetestsaredesignedprimarilytodeterminewhetherasubstanceorpreparationcomplieswithanestablishedspecificationformicrobiologicalquality.Whenusedforsuchpurposes,followtheinstructionsgivenbelow,includingthenumberofsamplestobetaken,andinterprettheresultsasstatedbe

3、low.这些检测主要设计用于测定一种物质或制备品是否符合已确立的微生物质量标准。当用于此类目的时，需遵照以下所给的说明，包括待取样品的数量，并且按照下面所述解释结果。Themethodsarenotapplicabletoproductscontainingviablemicroorganismsasactiveingredients.这些方法不适用于以活菌作为活性成分的产品。Alternativemicrobiologicalprocedures,includingautomatedmethods,maybeused,providedthattheire

4、quivalencetothePharmacopeialmethodhasbeendemonstrated.可以使用替代的微生物规程，包括自动化方法，只要已经证明它们与药典方法具同等作用。GENERALPROCEDURES通用规程Carryoutthedeterminationunderconditionsdesignedtoavoid12microbialcontaminationoftheproducttobeexamined.Theprecautionstakentoavoidcontaminationmustbesuchthattheydonota

5、ffectanymicroorganismsthataretoberevealedinthetest.18在经过设计可避免外来微生物污染供试产品的条件下，进行此项测定。用于避免污染的这些预防措施是必须做到，它们不会影响任何试图在此项检验中揭示的微生物。Iftheproducttobeexaminedhasantimicrobialactivity,thisis,insofaraspossible,removedorneutralized.Ifinactivatorsareusedforthispurpose,theirefficacyandtheirabs

6、enceoftoxicityformicroorganismsmustbedemonstrated.如果供试产品具有抗菌活性，则此活性需在尽可能的范围内去除或中和。如果将灭活剂用于这个目的，则必须证实它们的功效和对微生物不具毒性。Ifsurface-activesubstancesareusedforsamplepreparation,theirabsenceoftoxicityformicroorganismsandtheircompatibilitywithanyinactivatorsusedmustbedemonstrated.如果表面活性物质用于

7、样品制备，则必须证实它们对微生物不具毒性以及与所使用的任何灭活剂的兼容性。ENUMERATIONMETHODS计数法UsetheMembraneFiltrationmethodoroneofthePlate-CountMethods,asdirected.TheMost-Probable-Number(MPN)Methodisgenerallytheleastaccuratemethodformicrobialcounts;however,forcertainproductgroupswithverylowbioburden,itmaybethemosta

8、ppropriatemethod.按规定，使用膜过滤法或多个平板计