正电子显像剂^(18)F-FDG的制备与质量控制

Preparation and quality control of ^(18)F-FDG as a positron emission tomography imaging agent

目的 研究正电子断层显像剂２－１８Ｆ－２－脱氧－Ｄ－葡萄糖（１８Ｆ－ＦＤＧ）的制备与质量控制。方法采用回旋加速器，通过 １８Ｏ（ｐ，ｎ）１８核反应和亲核取代反应制备１８Ｆ－ＦＤＧ。对制备的１８Ｆ－ＦＤＧ进行质量控制研究。结果放射化学产率约为５４％， 用ＴＬＣ法和ＨＰＬＣ法测定化学纯度均大于９９％，放化纯度均大于９５％，１８Ｆ－ＦＤＧ各项质量控制指标符合药典要求。结 论制备的１８Ｆ－ＦＤＧ适用于临床ＰＥＴ。

Objective: To develop the preparation method and quality control of 2-deoxy-2-18F-fluoro-D-glucose (l8F-FDG), a positron emission tomography imaging agent. Methods 18F-FDG was synthesized via nuclear reaction 18O(p,n) 18F on 18O-enriched water and nucleophilic substitution reaction by cyclotron-FDG synthesis system. Quality control of 18F-FDG was studied. Results The corrected radiochemical yield was about 54%, and the chemical and radiochemical purity was above 95% by high-performance liguid chromatography and thin-layer chromatography. Conclusion High-quality 18F-FDG prepared in this study is suitable for clinical performance of PET.