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(223 Ra,225 Ac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。
Alpha nuclides are featured with characteristics of high radiolucent energy,short range,strong radiobiological effects and cytotoxic effects,and are currently considered to have a good application prospect for internal radiation therapy of a variety types of of cancers.At present,the number ofα-nuclides suitable for labeling therapeuticα-nuclide radiopharmaceuticals is limited,and it is very difficult to prepare and purify them.Therefore,mostα-nuclide radiopharmaceuticals are still kept in the clinical research stage.The quality control of radiopharmaceuticals is essential for patient medication safety and is also an important promotion for the study ofα-nuclide radiopharmaceuticals.In this paper,the international and domestic status of the study ofα-nuclide radiopharmaceuticals is reviewed,and the feasibility study strategies of quality control items,such as physical identification and radionuclide purity of common and most promisingα-radionuclides(223 Ra,225 Ac,etc.),are proposed according to the properties of nuclides.It is believed in the field that with the continuous deepening of the quality control study ofα-nuclide radiopharmaceuticals in research community of China,it will certainly promote the early marketing ofα-nuclide radiopharmaceuticals in China.
作者
邱学军
崔晓艳
邵长芳
王定坤
孔晓卉
杨柳
QIU Xuejun;CUI Xiaoyan;SHAO Changfang;WANG Dingkun;KONG Xiaohui;YANG Liu(HTA Co.,Ltd.,Beijing 102413,China)
出处
《标记免疫分析与临床》
CAS
2022年第11期1977-1980,共4页
Labeled Immunoassays and Clinical Medicine
