基于诊疗一体化放射性药物合成的全自动金属多功能卡套式模块设计及测试研究  

Study on the design and test of an automatically metal multi-functional card sleeve module for the synthesis of radiopharmaceuticals based on integrative diagnosis and treatment

作　　者：邢海群 刘宇[1,2] 任超 王瞳[1,2] 党永红 李方[1,2] 霍力 XING Hai-qun;LIU Yu;REN Chao(Department of Nuclear Medicine,Chinese Academy of Medical Sciences and Peking Union Medical College,Peking Union Medical College Hospital,Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院核医学科核医学分子靶向诊疗北京市重点实验室,北京100730 [2]中国医学科学院北京协和医学院北京协和医院疑难重症及罕见病国家重点实验室,北京100730

出　　处：《中国医学装备》2021年第4期1-5,共5页China Medical Equipment

基　　金：国家重点研发计划(2016YFC0901500)“罕见病临床队列研究”;中国医学科学院罕见病研究中心资助项目(2016ZX310174-4)“HLH精准医学系统的建设及应用示范”;中国医学科学院医学与健康科技创新工程资助项目(2016-I2M-1-002)“罕见病发病机制与诊疗新技术研究”。

摘　　要：目的:设计和测试一款国产全自动金属多功能卡套式模块,实现应用于肿瘤诊疗一体化的放射性药物安全、高效和稳定生产。方法:采用机械钣金和结构设计软件UG和Soidworks完成模块零部件设计及模拟装配后组装模块主机;基于C语言进行模块上位机控制程序编程设计。根据机电一体化思路,以“上位机-可编程逻辑控制器(PLC)-模块主机”交互方式,实现全自动化控制。在上位机控制软件中设置“镓68(^(68)Ga)-成纤维细胞活化蛋白抑制剂-04(^(68)Ga-FAPI-04)工艺程序”,进行^(68)Ga-FAPI-04的放射性自动合成。标记产物分别用放射性高效液相色谱仪(Radio-HPLC)和放射性薄层色谱扫描仪(Radio-iTLC)进行质量控制分析,并用于人胰腺癌细胞Panc-1异位移植瘤模型的微型正电子发射断层扫描(microPET)技术扫描显像动物实验。结果:经各冷实验进行功能测试,显示模块达到预设目标。该模块自动合成^(68)Ga-FAPI-04的合成效率为(72±3)%(10次实验),产物的放射化学纯度>99%,microPET结果中该标记探针在Panc-1荷瘤鼠肿瘤区域有明显的放射性摄取(4次实验)。结论:全自动金属多功能卡套式模块安全可行,可减少放射化学师的辐射暴露,其标记产物质量可靠,动物实验结果符合预期,该模块可保障放射性药物的稳定生产。Objective:To design and test a domestically automatic multi-functional metal card sleeve module so as to realize the safe,efficient and stable production of radiopharmaceuticals which was applied in the integrative theranostics of tumor.Methods:UG and Soidworks of mechanical metal plate and structural design software were adopted to complete the module parts design and to assemble host machine of module after simulated the assemble.The programming design of control program of module upper computer was performed based on C language.According to concept of mechatronics,the“upper computer-programmable logic controller(PLC)-module mainframe”interactive mode was adopted to achieve full-automatic control.The“Gallium-68(^(68)Ga)-fibroblast-activating protein inhibitor-04(^(68)Ga-FAPI-04)process program”was set in the control software of the upper computer to implement radioactively automatic synthesis of ^(68)Ga-FAPI-04.Quality control of the labeled product was performed with radioactive highperformance liquid chromatography(Radio-HPLC)and radioactive thin-layer chromatography scanner(RadioiTLC).And it was used in the animal experiment of scan presentation of micro positron-emission tomography(microPET)technique of human pancreatic carcinoma cell Panc-1 heterotopic tumor model.Results:The results of various cold experiment indicated that the module achieved the preinstalled target.And the synthetic efficiency that module automatically compound ^(68)Ga-FAPI-04 production was(72±3)%(n=10),and the radiochemical purity of the radiolabeled product was larger than 99%.And the results of microPET imaging showed that the labeled tracer had obvious radioactive uptake assay in the tumor region of PANC-1 mice with tumor(n=4).Conclusion:The full automatically metal multi-function card sleeve module is safe and feasible,which can reduce the radiation exposure of radiochemists,and the quality of labelled products with that is reliable.The results of animal experiment conforms to expectation,and this module can guarantee sta

关 键 词：放射性药物 金属多功能卡套式模块 自动化 镓68(68Ga) 成纤维细胞活化蛋白抑制剂-04(FAPI-04) 

分 类 号：R817.9[医药卫生—影像医学与核医学]