USP 88 生物实验文档格式.docx

USP 88 生物实验文档格式.docx

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Table1、ClassificationofPlastics

PlasticClassesa

TeststobeConducted

I

II

III

IV

V

VI

TestMaterial

Animal

Dose

Procedureb

x

ExtractofSampleinSodiumChlorideInjection

Mouse

50mL/kg

A（IV）

RabbitorGuineaPig

0、2mL/animal

ateachof10or6sites

B（IC）

ExtractofSamplein1in20SolutionofAlcoholinSodiumChlorideInjection

A（IP）

ExtractofSampleinPolyethyleneGlycol400

10g/kg

ExtractofSampleinVegetableOil

B（IC）

ImplantstripsofSample

Rabbit

4strips/animal

C

ImplantSample

Rat

2Samples/animal

C

a 

Testsrequiredforeachclassareindicatedby“x”inappropriatecolumns、

b 

Legend:

A（IP）—SystemicInjectionTest（intraperitoneal）;

B（IC）—IntracutaneousTest（intracutaneous）;

C—ImplantationTest（intramuscularorsubcutaneousimplantation）、

WiththeexceptionoftheImplantationTest,theproceduresarebasedontheuseofextractsthat,dependingontheheatresistanceofthematerial,arepreparedatoneofthreestandardtemperatures:

50

70

and121

、Therefore,theclassdesignationofaplasticmustbeaccompaniedbyanindicationofthetemperatureofextraction（e、g、,IV-121

whichrepresentsaclassIVplasticextractedat121

orI-50

whichrepresentsaclassIplasticextractedat50

）、

PlasticsmaybeclassifiedasUSPPlasticClassesI–VIonlyonthebasisoftheresponsecriteriaprescribedinTable1、

Thisclassificationdoesnotapplytoplasticsthatareintendedforuseascontainersfororalortopicalproducts,orthatmaybeusedasanintegralpartofadrugformulation、Table1doesnotapplytonaturalelastomers,whicharetobetestedinSodiumChlorideInjectionandvegetableoilsonly、

TheSystemicInjectionTestandtheIntracutaneousTestaredesignedtodeterminethesystemicandlocal,respectively,biologicalresponsesofanimalstoplasticsandotherpolymersbythesingle-doseinjectionofspecificextractspreparedfromaSample、TheImplantationTestisdesignedtoevaluatethereactionoflivingtissuetotheplasticandotherpolymersbytheimplantationoftheSampleitselfintoanimaltissue、TheproperpreparationandplacementofthespecimensunderasepticconditionsareimportantintheconductoftheImplantationTest、

Thesetestsaredesignedforapplicationtoplasticsandotherpolymersintheconditioninwhichtheyareused、Ifthematerialistobeexposedtoanycleansingorsterilizationprocesspriortoitsend-use,thenthetestsaretobeconductedonaSamplepreparedfromaspecimenpreconditionedbythesameprocessing、

Factorssuchasmaterialcomposition,processingandcleaningprocedures,contactingmedia,inks,adhesives,absorption,adsorptionandpermeabilityofpreservatives,andconditionsofstoragemayalsoaffectthesuitabilityofamaterialforaspecificuse、Evaluationofsuchfactorsshouldbemadebyappropriateadditionalspecificteststodeterminethesuitabilityofamaterialforitsintendeduse、

USPReferenceStandards

11

—USPHigh-DensityPolyethyleneRS、

ExtractingMedia—

sodiumchlorideinjection（seemonograph）、UseSodiumChlorideInjectioncontaining0、9%ofNaCl、

1in20solutionofalcoholinsodiumchlorideinjection、

polyethyleneglycol400（seemonograph）、

vegetableoil—UsefreshlyrefinedSesameOil（seemonograph）orCottonseedOil（seemonograph）orothersuitablevegetableoils、

drugproductvehicle（whereapplicable）、

waterforinjection（seemonograph）、

Note—TheSesameOilorCottonseedOilorothersuitablevegetableoilmeetsthefollowingadditionalrequirements、Obtain,ifpossible,freshlyrefinedoil、Usethreeproperlypreparedanimals,andinjecttheoilintracutaneouslyinadoseof0、2mLintoeachof10sitesperanimal,andobservetheanimalsat24,48,and72hfollowinginjection、RatetheobservationsateachsiteonthenumericalscaleindicatedinTable2、Forthe3rabbitsorguineapigs（30or18injectionsites）,atanyobservationtime,theaverageresponseforerythemaisnotgreaterthan0、5andforedemaisnotgreaterthan1、0,andnositeshowsatissuereactionlargerthan10mminoveralldiameter、Theresidueofoilattheinjectionsiteshouldnotbemisinterpretedasedema、Edematoustissueblancheswhengentlepressureisapplied、

Table2、EvaluationofSkinReactionsa

ErythemaandEscharFormation

Score

Noerythema

Veryslighterythema（barelyperceptible）

1

Well-definederythema

2

Moderatetosevereerythema

3

Severeerythema（beet-redness）toslightescharformation（injuriesindepth）

4

EdemaFormationb

Noedema

Veryslightedema（barelyperceptible）

Slightedema（edgesofareawelldefinedbydefiniteraising）

Moderateedema（raisedapproximately

1mm）

Severeedema（raisedmorethan1mmandextendingbeyondtheareaof

exposure）

a 

DraizeJH,WoodwardG,CalveryHO、Methodsforthestudyofirritationandtoxicityofsubstancesappliedtopicallytotheskinandmucousmembranes、JPharmacolExpTher1944;

82:

377–390、

b 

Excludesnoninflammatory（mechanical）edemafromtheblankorextractionfluid、

Apparatus—Theapparatusforthetestsincludesthefollowing、

autoclave—Useanautoclavecapableofmaintainingatemperatureof121±

2、0

equippedwithathermometer,apressuregauge,aventcock,arackadequatetoaccommodatethetestcontainersabovethewaterlevel,andawatercoolingsystemthatwillallowforcoolingofthetestcontainerstoabout,butnotbelow,20

immediatelyfollowingtheheatingcycle、

oven—Useanoven,preferablyaforced-circulationmodel,thatwillmaintainoperatingtemperaturesof50

or70

within±

、

extractioncontainers—Useonlycontainers,suchasampulsorscrew-capculturetesttubes,ofTypeIglass、Ifused,culturetesttubesareclosedwithscrewcapshavingsuitableelastomericliners、Theexposedsurfaceoftheelastomericlineriscompletelyprotectedwithaninertsoliddisk0、05–0、075mminthickness、Asuitablediskmaybefabricatedfromapolytefresin、

PreparationofApparatus—Cleanseallglasswarethoroughlywithchromicacidcleansingmixture,orifnecessary,withhotnitricacid,followedbyprolongedrinsingwithwater、Cleancuttingutensilsbyanappropriatemethod（e、g、,successivecleaningwithacetoneandmethylenechloride）priortouseinsubdividingaspecimen、Cleanallotherequipmentbythoroughscrubbingwithasuitabledetergentandprolongedrinsingwithwater、

Rendercontainersandequipmentusedforextraction,andintransferandadministrationoftestmaterial,sterileanddrybyasuitableprocess、[Note—Ifethyleneoxideisusedasthesterilizingagent,allowadequatetimeforcompletedegassing、]

Procedure—

preparationofsample—BoththeSystemicInjectionTestan