18F比他班自动化合成及初步临床应用

Automated Synthesis and Preliminary Clinical Application of 18F-Florbetabe

  • 摘要:18F比他班(18F-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18F-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,18F-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18F-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。

     

    Abstract: 18F-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 18F-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 18F-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 18F-florbetaben is effective for Alzheimer’s diseases. All these results confirm that, the process for the automated synthesis of 18F-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 18F-florbetaben.

     

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