ASTM E1882-2010 使用琼脂贴片法评估抗菌配方的标准试验方法

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【英文标准名称】:StandardTestMethodforEvaluationofAntimicrobialFormulationsbytheAgarPatchTechnique
【原文标准名称】:使用琼脂贴片法评估抗菌配方的标准试验方法
【标准号】:ASTME1882-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E35.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:agarpatch;antibacterial;antimicrobial;controlformulation;residentmicroorganism;persistentactivity;transientmicroorganism;Transientmicroorganism;Agarpatchtechnique;Antibacterialwashes;Controlledtestingconditions/environments;Inhibitio
【摘要】:Thisprocedurecanbeusedtoevaluateformulationscontainingingredientsintendedtoinhibitgrowthofbacteriaonintactskinandmeasuresthedifference,post-product-exposure,betweennumbersofbacterialcoloniesonactivetestformulationplatesandnumbersoncontrolplates,expressedaspercentinhibition.Thisproceduremayalsobeusedtotestforpersistenceofactivity,asafunctionoftimeelapsedbetweenapplicationofactivetestformulationandapplicationofactivetestplates.Becausenoprocedureforneutralizationoftheantimicrobialactionofactiveingredientscanbeincludedinthetest,theagarpatchmethodislimitedtotheextentthatresultsexpressedaspercentinhibitiondonotdifferentiatebetweenbacteristaticandbactericidaleffectsand,hence,mustnotbeportrayedasx201C;reductions.x201D;1.1Thistestmethoddeterminestheantibacterialactivityandpersistenceoftestformulations,asmeasuredbytheinhibitionofatestorganismonanagarsurfaceexposedtotestsitesonhumanskintreatedwiththeformulations.1.2Aknowledgeofmicrobiologicaltechniquesisrequiredfortheseprocedures.1.3ItistheresponsibilityoftheinvestigatortodetermineifGoodLaboratoryPractice(GLP)andGoodClinicalPractice(GCP)arerequiredandtoadheretothesepractices,asappropriate.1.4Inthistestmethod,SIunitsareusedforallapplicationsexceptlinearmeasure.Inthatcase,inchesareusedandSIunitsfollowinparentheses.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Performanceofthisprocedurerequirestheknowledgeofregulationspertainingtotheprotectionofhumansubjects(see21CFR,Ch.I,Parts50and56).
【中国标准分类号】:Y40
【国际标准分类号】:71_100_40
【页数】:4P.;A4
【正文语种】:英语