住友F300E-2自动合成18F-FDG及质量控制

Automatic Synthesis and Quality Control of 18F-FDG Using SUMITOMO F300E-2

目的分析安装和使用正电子药物合成器(F300E-2)的稳定性和实用性。方法基于F300E-2合成器及其制备工艺流程,进行^18F-FDG合成产量和质量测试及其质量控制。结果所有合成批次^18F-FDG合成产率值分布于42.80%~64.60%,其中91.01%批次合成产率超过55%,50.56%批次合成产率超过60%。质量控制结果为所有批次^18F-FDG均为无色澄明水溶液,pH=6.7~7.0,放射性化学纯度大于98%。利用线性拟合法、指数拟合法计算某批次样品放射性核素半衰期数值分别为109.652 min和112.135 min。结论新F300E-2合成器合成产率高、性能稳定、实用性较强,产品各项质量控制指标均符合药典规定。

Objective To analyze the stability and practicability of positron medicine synthesizer(F300E-2)during installation and use processes.Methods Based on F300E-2 synthesizer and its synthesis technology,the synthetic yield and quality testing of ^18F-FDG were carried out,and quality control of ^18F-FDG was performed.Results Synthetic yield of ^18F-FDG samples distributed mainly in 42.80%~64.60%,among which 91.01%samples’synthetic yield over 55%,and 50.56%samples’synthetic yield over 60%.The quality control results showed that all batches of ^18F-FDG samples were colorless transparent solution,with pH=6.7~7.0 and radiochemical purity more than 98%.The radionuclide half-life were 109.652 min and 112.135 min by linear fitting method and exponential fitting method.Conclusion F300E-2 synthesizer has the advantages of high yield,stable performance and strong practicability,and all the quality control indexes of its synthetic products are in line with standards of pharmacopoeia.