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目的研究正电子药物18F-FDG的制备与质量控制以及影响18F-FDG合成效率的因素。方法使用医用回旋加速器,通过18O(p,n)18F核反应,采用Explora FDG4全自动合成系统制备了18F-FDG静脉注射液,对于制备的药物进行质量控制与影响因素分析。结果Explora FDG4合成效率65%,18F-FDG放化纯度99% 18F-FDG其他指标符合药典质量要求,反应体系中残留的水等影响合成效率。结论制备的18F-FDG静脉注射液使用临床PET-CT检查。
Objective To study the preparation and quality control of 18F-FDG and the factors affecting the efficiency of 18F-FDG synthesis. Methods The 18F-FDG intravenous injection was prepared by the 18O (p, n) 18F nuclear reaction using the Auto-cyclotron and the Explora FDG4 automatic synthesis system was used. The quality control and influential factors of the prepared 18F-FDG were analyzed. Results Explora FDG4 synthesis efficiency of 65%, 18F-FDG radiochemical purity of 99% 18F-FDG other indicators in line with the quality requirements of the Pharmacopoeia, the residual water in the reaction system affect the synthesis efficiency. Conclusion The 18F-FDG intravenous injection prepared by clinical PET-CT examination.