中国药典微生物检测翻译稿Appendix XI J Microbial Limit Test MethoWord格式文档下载.docx

中国药典微生物检测翻译稿Appendix XI J Microbial Limit Test MethoWord格式文档下载.docx

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Themicrobiallimittestshouldbeperformedinthe100-Classcleanareawithone-directionairflowintroducedin,whichsettledinthe10000-Classcleanenvironment.Andallthetestsshouldstrictlycomplywithsteriletechniquetoprotectrecontamination.Thecleanlinessoftheone-directionairflowarea,workingbenchandtheenvironmentshouldbevalidatedbaseduponcurrentnationalcriteriaonTestMethodforAirborneParticles,AirborneMicrobeandSettlingMicrobeinCleanRoom（area）ofthePharmaceuticalIndustryregularly.

Ifthesubstancestobeexaminedhavesurface-activeagents,neutralizingagentsorinactivators,theirefficacyandabsenceofinfluenceformicro-organismsmustbedemonstrated.

Theculturingtemperatureforbacteriais30~35˚C;

formoldsandyeasts23~28˚C;

andforspecifiedmicro-organisms35~37˚C,unlessotherwiseprescribed.

Theresultsshouldbereportedin1g,1ml,10g,10mlor10cm2.

TestAmount

Testamountistheamountofthesampletobeexaminedonce（ing,mlorcm2）.

Thetestamountisnormally10gor10ml,unlessotherwiseprescribedforchemicalfilms100cm2;

forexpensiveormicro-packageddrugs,reducedtestamountisacceptable.ThesampletobeexaminedforSalmonellaanother10gor10mlisrequired.

Whiletesting,samplefrommorethan2minimumpackages,forfilmsatleast4sheets.

Generallyspeaking,randomlysample3timesofthetestamount（morethantwominimumpackages）.

PreparationofTestSolution

Thesuitablemethodfortestsolutionpreparationdependsuponthephysicalandbiologicalcharacteristicsofthesubstance.Ifthepreparationintroduceswaterbathforheating,thetemperatureshouldn’texceed45˚C.Assoonasthetestsolutionisprepared,theculturemediumshouldbeaddedwithin1hour.

Unlessotherwiseprescribed,thecommonpreparationmethodsarepresentedasfollows.

1.Liquidproducts

Take10mlofthesample,addinsterilebufferedsodiumchloride-peptonesolutionpH7.0to100ml,andmixwelltoobtain1in10dilution.Foroils,addinsuitablequantityofsterilepolysorbate80toevenly-dispersethetestsolution;

andforwater-solubleliquidproducts,mixedsampleconcentratecanbeusedastestsolution.

2.Solid,semisolidorviscousproducts

Take10gofthesample,addinsterilebufferedsodiumchloride-peptonesolutionpH7.0to100ml,andmixwellwithhomogenizerorothersuitablemethods,toobtain1in10dilution.Addinsuitablequantityofsterilepolysorbate80andproperlyheatwithwaterbathtodispersethesampleevenly.

3.Productspreparedbyspecialprocedures

（1）Water-insolubleproducts

Method1Take5g（or5ml）ofthesample,andaddtothebeakerinwhichthereisdissolvedsterilemixture（temperaturenotmorethan45˚C）containing5gofTween80,3gofglycerylmonostearateand10gofpolysorbate80.Stirtobemasswithsterileglassrod.Thenslowlyaddin45˚Csterilebufferedsodiumchloride-peptonesolutionpH7.0to100ml,whilestirring.Emulsifycompletelytoobtain1in20dilution.

Method2Take10gofthesample,andaddtothesuitablecontainerinwhichthereare20mlofsterileisopropylmyristate（refertotheSterilityTestinAppendixXIHSterilityTestforpreparationmethods）andsterileglassballs.Ifnecessary,increasetheamountofisopropylmyristateused.Shakeandvibratetodissolvecompletely.Thenaddin45˚Csterilebufferedsodiumchloride-peptonesolutionpH7.0to100ml,vibratefor5~10minutestoextract,andstandstilltolaminatethewaterandoil.Takethewaterlayeras1in10dilution.

（2）Filmsproducts

Take100cm2ofthesample,cutintopieces,addin100mlofsterilebufferedsodiumchloride-peptonesolutionpH7.0（Ifnecessaryincreasetheamountadded）,soak,andvibratetoobtain1in10dilution.

（3）Entericorcolonictargetingproducts

Take10gofthesample,addinsterilephosphatebuffersolutionpH6.8（forenterictargetingproducts）orsterilephosphatebuffersolutionpH7.6（forcolonictargetingproducts）to100ml,andplacein45˚Cwaterbath.Shakeandvibratetodissolve,andobtain1in10dilution.

（4）AerosolandSprayproducts

Takespecifiedamountofthesample,freezeinfreezingroomforabout1hour.Takeoutandsterilizetheopenpartofthesamplequickly.Drillasmallholewithsterilesteelawlinthesterilizepart,andsettleinroomtemperature.Gentlyrotatethecontainertoreleaseallthepropellantsslowly.Thensuckallthproductsoutwithsterilesyringe,addtothesuitablequantityofsterilebufferedsodiumchloride-peptonesolutionpH7.0（Ifwate