USP 88 生物实验文档格式.docx
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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
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