18F-FDG的稳定性及提高稳定性的方法

本工作研究了常规制备的大剂量、高浓度¹⁸F-FDG的稳定性,并在产品中添加稳定剂乙醇或对已部分分解的产品进行再纯化，以提高¹⁸F-FDG的放化纯度。结果显示，当¹⁸F-FDG产品浓度高于6 TBq/L时，放置4 h，其放化纯度＜95%；浓度大于7.4 TBq/L时，添加体积分数为0.1%的乙醇后，能明显降低¹⁸F-FDG的分解，6 h后放化纯度＞95%；已分解的¹⁸F-FDG经再纯化后，放化纯度＞99%。Micro PET/CT大鼠显像表明，采用已分解的¹⁸F-FDG对大鼠进行显像，其股骨有明显摄取；对其进行再纯化处理后对大鼠显像，大鼠股骨无放射性摄取。以上结果表明，高浓度的¹⁸F-FDG有效时间小于4 h；添加0.1%乙醇可明显减慢高浓度¹⁸F-FDG分解，而再纯化方法可以彻底除去分解的放射性杂质。为保证¹⁸F-FDG质量，将添加稳定剂和再纯化两种方法联合使用，保证产品放化纯度的同时还可提高¹⁸F-FDG的利用率。

Stability and the Improved Methods of 18F-FDG

To study the stability of 18F-FDG with routinely synthesis at high radio-dose and high radioconcentration,18F-FDG was added 0.1% ethanol or repurification by solid-phase extraction for radiolytic 18F-FDG to improve its radiochemical purity(RCP).The results showed that the RCP declined from 99% to 95% within 4 h at 6 TBq/L for room temperature(RT).The radiolysis could be depressed with 0.1% ethanol,the RCP could be over 95% even if the radioactivity concentration was 7.4 TBq/L at RT for 6 h.The repurificatio...