多巴胺转运蛋白显像剂[^(18)F]氟-β-FP-CIT的生物学检测研究  

Research on the Biological Detection of Dopamine Transporter Imaging Agent [^(18)F] Fluoro-β-FP-CIT

作　　者：时光[1] 程亮 王可铮 SHI Guang;CHENG Liang;WANG Kezheng(Department of Criminal Science and Technology Jilin Police College,Changchun 130117,China;PET-CT/MRI Center,Affiliated Cancer Hospital of Harbin Medical University,Harbin 150081,China)

机构地区：[1]吉林警察学院,吉林长春130117 [2]哈尔滨医科大学附属肿瘤医院PET-CT/MRI中心,黑龙江哈尔滨150081

出　　处：《工业微生物》2023年第3期46-49,共4页Industrial Microbiology

基　　金：2022年度吉林省教育厅科学技术研究项目“毒(药)品成瘾及戒断效果评价多巴胺转运体(DAT)显像剂18F-FP-CIT的合成及质量控制研究”(JJKH20220928)。

摘　　要：对实验室中合成的^(18)F-N-3-氟丙基-2-甲酯基-3β-(4-碘苯基)降托烷(^(18)F-β-FP-CIT)细菌进行内毒素和无菌检测,看其是否能达到《中国药典》对注射剂的要求,在百级净化热室内将目标产物放置十个半衰期后,用鲎试剂法检测细菌内毒素和用细菌培养法进行无菌热源检测。结果显示,^(18)F-β-FP-CIT的细菌内毒素小于15 EU,细菌培养对照结果为阴性。最终得出结论,^(18)F-β-FPCIT可以用CFN-MPS200合成模块全自动稳定合成,产品生物学检测结构达到了《中国药典》的要求。To test whether the bacterial endotoxin and sterility of ^(18)F-N-3-fluoropropyl-2β-methyl ester-3β-(4-iodophenylphenylpropane(^(18)F-β-FP-CIT)synthesized in the laboratory can meet the requirements of the Chinese Pharmacopoeia for Injection.After the target product was placed in a 100-level purification hot chamber for ten half-lives,the test results of the limulus reagent method for bacterial endotoxin and the sterile heat source of the bacterial culture method were ^(18)F-β-FP-CIT bacterial endotoxin was less than 15 EU,and the bacterial culture result was negative.^(18)F-β-FP-CIT can be fully automatically and stably synthesized by the CFN-MPS200 synthesis module,and the biological detection structure of the product meets the requirements of the"Chinese Pharmacopoeia".

关 键 词：多巴胺转运蛋白显像 药物成瘾 细菌内毒素检测 无菌检测 

分 类 号：R44[医药卫生—诊断学]