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1、血液制品病毒滅活_去除技術(shù)平臺(tái)的建立與應(yīng)用_尹惠瓊軍事醫(yī)學(xué)2015年3月第39卷第3期MilMedSci,Vol39,No3,Mar,2015165檭檭殐檭檭檭檭檭檭檭檭殐尹惠瓊,王[摘要]目的蕊,朱鳳宣,王建國(guó),章金剛建立血液制品病毒滅活/去除技術(shù)并應(yīng)用于血液制品的病毒滅活/去除工藝驗(yàn)證。方法建立指示病毒庫(kù)以及S/D處理法、低pH孵放法、干熱法、巴氏消毒法、納米膜過(guò)濾法等血液制品病毒滅活/去除技術(shù),采用Spearman和Karber法計(jì)算病毒滴度,病毒滴度降低量(LRV)≥4判為有效,對(duì)企業(yè)的血細(xì)胞病變法測(cè)定病毒滴度
2、,液制品樣品進(jìn)行病毒滅活/去除驗(yàn)證。結(jié)果S/D處理法和低pH孵放法可有效滅活有包膜指示病毒,干熱法和巴所建氏消毒法可有效滅活有、無(wú)包膜指示病毒,納米膜過(guò)濾法可在一定過(guò)濾量范圍內(nèi)去除PPV指示病毒。結(jié)論[關(guān)鍵詞]血液制品;病毒———————————————————————————————————————————————滅活;消毒[33中圖分類(lèi)號(hào)]R392-[9960(2015)03-0165-04文章編號(hào)]1674-[文獻(xiàn)標(biāo)志碼]ADOI:10.7644/j.issn.1674-9960.2015.03.002立的血液制
3、品病毒滅活/去除技術(shù)可用于血液制品的病毒滅活/去除工藝驗(yàn)證,以提高血液制品的病毒安全性。Establishmentandapplicationofviralinactivation/removaltechnologyforbloodproductsYINHui-qiong,WANGRui,ZHUFeng-xuan,WANGJian-guo,ZHANGJin-gang*(InstituteofTransfusionMedicine,AcademyofMilitaryMedicalSciences,Beijing10085
4、0,China)*Correspondingauthor,Tel:010-66932221,E-mail:zhangjg@bmi.a(chǎn)c.cn[Abstract]ObjectiveToestablishviralinactivation/removaltechniquesforbloodproducts,andapplythemtoinacti-Envelopedandnon-envelopedmodelviruseswerepropaga-vation/removalprocessvalidationofbloodpr
5、oducts.Methodsted.Viralinactivation/removaltechniquesforbloodproducts,———————————————————————————————————————————————includingsolvent/detergent(S/D)treatment,lowpHincuba-andnanofiltration,wereestablished.Thevirustiterwasevaluatedusingcytopathiction,dryheatmethod
6、,pasteurization,effects(CPE)andSpearmanandKarbermethod.Theviralinactivation/removaltechniqueswerebelievedtobeeffectivewhenLRV≥4.Thesetechniqueswereusedinviralinactivation/removalvalidationofbloodproducts.ResultsEnvelopedmodelviruseswereinactivatedthroughS/Dtreat
7、mentandthelowpHincubationmethod.Envelopedandnon-envelopedmodelviruseswereinactivatedthroughdryheatandpasteurization.Withinacertainrangeoffiltrationcapacity,PPVwasremovedthroughnanofiltration.ConclusionTheestablishedviralinactivation/removaltechniquescanbeusedinv
8、iralinactivation/removalprocessvalidationofbloodproducts,whichcanimproveviralsafetyofbloodproducts.[Keywords]bloodproducts;viralinactivation;disinfection血液制品(bloodpro