α核素放射性药品质量控制方法浅析邱学军,崔晓艳,邵长芳,王定坤,孔晓卉,杨柳(原子高科股份有限公司,北京102413)DOI:10.11748/bjmy.issn.1006-1703.2022.11.035收稿日期:2022-07-05;修回日期:2022-09-07通讯作者:杨柳。E-mail:yangliu1@circ.com.cn摘要:α核素具有透射线能量高、射程短、放射生物学效应和细胞毒性作用强等特点,被认为对多种癌症的体内放射治疗都具有良好的应用前景。目前,适合于标记治疗用α核素放射性药品的α核素数量少,制备和纯化都十分困难,因此,至今多数α核素放射性药品仍处于临床研究阶段。放射性药品的质量控制对患者用药安全至关重要,也是对α核素放射性药品研究的重要推动。本文对α核素放射性药品研究的国际、国内现状进行了调研,并根据核素性质提出了常见及最有前景的α放射性核素(223Ra,225Ac等)的物理鉴别、放射性核纯度等质控项目的可行性研究思路,相信随着国内α核素放射性药品质量控制研究的不断深入,必定能够推动α核素放射性药品在国内早日获批上市。关键词:α核素放射性药品;质量控制;放射性核纯度;225Ac;223Ra中图分类号:文献标识码:AAnAnalysisofQualityControlofAlphaNuclideRadiopharmaceuticalsQIUXuejun,CUIXiaoyan,SHAOChangfang,WANGDingkun,KONGXiaohui,YANGLiu(HTACo.,Ltd.,Beijing102413,China)Abstract:Alphanuclidesarefeaturedwithcharacteristicsofhighradiolucentenergy,shortrange,strongradiobiologicaleffectsandcytotoxiceffects,andarecurrentlyconsideredtohaveagoodapplicationprospectforinternalradiationtherapyofavarietytypesofofcancers.Atpresent,thenumberofα-nuclidessuitableforlabelingtherapeuticα-nuclideradiopharmaceuticalsislimited,anditisverydifficulttoprepareandpurifythem.Therefore,mostα-nuclideradiopharmaceuticalsarestillkeptintheclinicalresearchstage.Thequalitycontrolofradiopharmaceuticalsisessentialforpatientmedicationsafetyandisalsoanimportantpromotionforthestudyofα-nuclideradiopharmaceuticals.Inthispaper,theinternationalanddomesticstatusofthestudyofα-nuclideradiopharmaceuticalsisreviewed,andthefeasibilitystudystrategiesofqualitycontrolitems,suchasphysicalidentificationandradionuclidepurityofcommonandmostpromisingα-radionuclides(223Ra,225Ac,etc.),areproposedaccordingtothepropertiesofnuclides.Itisbel...
