摘要
氟[^(18)F]比他班(^(18)F-florbetaben)是美国FDA于2014年批准上市的β-淀粉样蛋白显像剂,主要用于诊断阿尔茨海默病(AD)或其他认知障碍疾病。本研究使用改良后的国产氟多功能模块,建立^(18)F-florbetaben自动化生产工艺,并针对其临床应用效果进行初步验证。结果显示,^(18)F-florbetaben自动化合成耗时38 min,不校正合成效率为(45.0±2.3)%(n=6),放化纯度大于95%,其临床PET显像效果理想。结果表明,国产氟多功能模块可实现^(18)F-florbetaben的自动化生产,且工艺可靠,合成时间短。本文研究成果有助于推动该显像剂的国内临床使用。
^(18)F-florbetaben is of great value in the diagnosis of Alzheimer’s diseases.In this study,a simple and reliable process for the automated production of^(18)F-florbetaben was established by using improved domestic fluorine multifunctional modules,and preliminary clinical studies were carried out to validate the clinical application value.Results show that the automated synthesis of^(18)F-florbetaben takes 38 minutes,the no-corrected synthesis efficiency is(45.0±2.3)%(n=6),and the radiochemical purity is more than 95%.Results of human PET show that^(18)F-florbetaben is effective for Alzheimer’s diseases.All these results confirm that,the process for the automated synthesis of^(18)F-florbetaben using domestic fluorine multifunctional module is concise,reliable and reproducible,also the quality fully meets the clinical requirements.Our results can promote the domestic applications of^(18)F-florbetaben.
作者
付华平
张晓军
常燕
王媛
张锦明
FU Huaping;ZHANG Xiaojun;CHANG Yan;WANG Yuan;ZHANG Jinming(Department of Nuclear Medicine,the First Center of Chinese PLA General Hospital,Beijing 100853,China)
出处
《同位素》
CAS
2021年第4期381-386,I0004,共7页
Journal of Isotopes
基金
国家重大科研仪器研制项目(61927807)
国家重点研发计划(2017YFC0112905)。
