【摘要】 目的研制血清胆固醇参考物质（简称参考血清）为酶法测定胆固醇提供合适的标准品，提高胆固醇测定的准确性，为在中国推行胆固醇测定标准化准备必要的条件。方法按国家标准物质的要求，收集大批量新鲜健康人混合血清，无菌分装，作均一性与稳定性试验，以参考方法标定胆固醇值。结果参考血清均匀性符合要求，保存３７℃２１天、室温９０天、４℃及－２０℃３年胆固醇值变动＜１％。以高效液相色谱法标定９２０２２９血清的胆固醇值为３．７７６±０．０３８ｍｍｏｌ／Ｌ。有关单位评价结果良好。结论参考血清均匀性、稳定性良好，定值可靠，已被国家技术监督局批准为国家一级标准品。更多还原

【Abstract】 ObjectiveToprovideanaccuratebaseforserumcholesteroldetermination,andtoprovideapointofreferenceforefectivecholesterollaboratorystandardizationinChina.MethodsAccordingtotherequirementsofnationalstandardmaterials,alargebatchoffreshhumanserafromhealthydonorswascolected,welmixedwithpreservativesundersterileconditions,anddividedintosmalampoulesin1mlportionsealed.Samplingbyrandomaccessmethod,thehomogeneityandsta-bilityoftheseruminampouleswereexaminedbyenzymaticcholesteroldeterminations.Thecholes-terolvalueofthereferenceserumwasdeterminedaccuratelybyreferencemethod.ResultsTheam-pouledserumsampleswereprovedtobehomogeneousandstable.Therewasnosignificantchangeincholesterolvalueafterstoragefor21daysat37℃,90daysatroomtemperature,3yearsat4℃or-20℃.Thedesignatedcholesterolvalue(serumlot920229)asdeterminedbyourHPLCreferencemethodis3.776±0.038mmol/L.ConclusionsThepreparedcholesterolreferenceserumhasgoodhomogeneity,stabilityandaccuratelycalibratedcholesterolvalue.IthasbeenapprovedastheNa-tionalStandardReferenceMaterial(GBW09138)bytheNationalBureauofTechnicalSupervisionofChina.更多还原