ASTM E2526-2008 测定猪肾细胞和人类肝癌细胞中纳米粒子材料的细胞毒性的标准试验方法
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【英文标准名称】:StandardTestMethodforEvaluationofCytotoxicityofNanoparticulateMaterialsinPorcineKidneyCellsandHumanHepatocarcinomaCells
【原文标准名称】:测定猪肾细胞和人类肝癌细胞中纳米粒子材料的细胞毒性的标准试验方法
【标准号】:ASTME2526-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:E56.02
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:cytotoxicity;hepatocytes;kidneycells;nanoparticles;Cytotoxicity;Hepatocytes;Kidneycells;Nanoparticles;Cytotoxicity;Hepatocytes;Kidneycells;Nanoparticles
【摘要】:Assessingthepropensityofananomaterialtocausecytotoxicitytothecellsofatargetorgancanassistinpreclinicaldevelopment.ThestandardhistoricalcytotoxicitytestingofmaterialsandextractsofmaterialshasusedfibroblastsandiswelldocumentedinPracticeF813,TestMethodF895,andISO10993-5.TheuseofmacrophagesandmicronsizeparticleshasalsoprovidedinformationoncytotoxicityandstimulationusingPracticeF1903.Thistestmethodaddstothecytotoxicitytestprotocolsbyusingtargetorgancells.TwoquantitativeassaysmeasuringLDHleakageandMTTreductionareusedtoestimatecytotoxicity.Thistestmethodmaynotbepredictiveofeventsoccurringinalltypesofnanomaterialapplicationsandtheuseriscautionedtoconsidertheappropriatenessofthetestforvarioustypesofnanomaterialapplications.Thisprocedureshouldonlybeusedtocomparethecytoxicityofaseriesofrelatednanomaterials.Meaningfulcomparisonofunrelatednanomaterialsisnotpossiblewithoutadditionalcharacterizationofphysicochemicalpropertiesofeachindividualnanomaterialintheassaymatrix.1.1Thistestmethodprovidesamethodologytoassessthecytotoxicityofsuspensionsofnanoparticulatematerialsinporcineproximaltubulecells(LLC-PK1)andhumanhepatocarcinomacells(HepG2)whichrepresentspotentialtargetorgansfollowingsystemicadministration1.2Thistestmethodispartoftheinvitropreclinicalcharacterizationcascade.1.3Thistestmethodconsistsofaprotocolutilizingtwomethodsforestimationofcytotoxicity,3-(4,5-Dimethylthiazolyl-2)-2,5-diphenyltetrazoliumbromide(MTT)reductionandlactatedehydrogenase(LDH)release.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:B41
【国际标准分类号】:07_100_10
【页数】:6P.;A4
【正文语种】:英语
【原文标准名称】:测定猪肾细胞和人类肝癌细胞中纳米粒子材料的细胞毒性的标准试验方法
【标准号】:ASTME2526-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:E56.02
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:cytotoxicity;hepatocytes;kidneycells;nanoparticles;Cytotoxicity;Hepatocytes;Kidneycells;Nanoparticles;Cytotoxicity;Hepatocytes;Kidneycells;Nanoparticles
【摘要】:Assessingthepropensityofananomaterialtocausecytotoxicitytothecellsofatargetorgancanassistinpreclinicaldevelopment.ThestandardhistoricalcytotoxicitytestingofmaterialsandextractsofmaterialshasusedfibroblastsandiswelldocumentedinPracticeF813,TestMethodF895,andISO10993-5.TheuseofmacrophagesandmicronsizeparticleshasalsoprovidedinformationoncytotoxicityandstimulationusingPracticeF1903.Thistestmethodaddstothecytotoxicitytestprotocolsbyusingtargetorgancells.TwoquantitativeassaysmeasuringLDHleakageandMTTreductionareusedtoestimatecytotoxicity.Thistestmethodmaynotbepredictiveofeventsoccurringinalltypesofnanomaterialapplicationsandtheuseriscautionedtoconsidertheappropriatenessofthetestforvarioustypesofnanomaterialapplications.Thisprocedureshouldonlybeusedtocomparethecytoxicityofaseriesofrelatednanomaterials.Meaningfulcomparisonofunrelatednanomaterialsisnotpossiblewithoutadditionalcharacterizationofphysicochemicalpropertiesofeachindividualnanomaterialintheassaymatrix.1.1Thistestmethodprovidesamethodologytoassessthecytotoxicityofsuspensionsofnanoparticulatematerialsinporcineproximaltubulecells(LLC-PK1)andhumanhepatocarcinomacells(HepG2)whichrepresentspotentialtargetorgansfollowingsystemicadministration1.2Thistestmethodispartoftheinvitropreclinicalcharacterizationcascade.1.3Thistestmethodconsistsofaprotocolutilizingtwomethodsforestimationofcytotoxicity,3-(4,5-Dimethylthiazolyl-2)-2,5-diphenyltetrazoliumbromide(MTT)reductionandlactatedehydrogenase(LDH)release.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:B41
【国际标准分类号】:07_100_10
【页数】:6P.;A4
【正文语种】:英语
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