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新型18F-脱氧葡萄糖注射液的制备与质量控制
引用本文:李军,李广义,高铎.新型18F-脱氧葡萄糖注射液的制备与质量控制[J].华西药学杂志,2004,19(1):8-10.
作者姓名:李军  李广义  高铎
作者单位:山东省立医院PET中心,山东,济南,250021;山东省立医院PET中心,山东,济南,250021;山东省立医院PET中心,山东,济南,250021
摘    要:目的 研究^18F-脱氧葡萄糖(^18F-FDG)注射液的制备和质量控制方法。方法应用小型回旋加速器,通过^18O(p,n)^18F核反应生产出^18F离子,由亲核取代反应制备^18F-FDG,并对所制备的^18F-FDG注射液进行质量控制。结果采用新型^18F-FDG化学合成方法后,放射化学产率可达72%,HPLC法测定的化学纯度大于99%,TLC测定放化纯度大于95%,^18F-FDG注射液的各项质量控制指标均符合《美国药典》的要求。结论 新型^18F脱氧葡萄糖注射液可应用于临床PET的检查。

关 键 词:18F-脱氧葡萄糖  Tracerlab  合成  质量控制
文章编号:1006-0103(2004)01-0008-03

New method for preparation and quality control of 18F-FDG injection
LI Jun,LI Guang-yi,GAO Duo.New method for preparation and quality control of 18F-FDG injection[J].West China Journal of Pharmaceutical Sciences,2004,19(1):8-10.
Authors:LI Jun  LI Guang-yi  GAO Duo
Abstract:OBJECTIVE To develop a new method for preparation and quality control of 18F-FDG injection.METHODS 18F-FDG was synthesized via nuclear reaction 18O(p,n) 18F on 18O-enriched water and nucleophilic substitution reaction by Tracerlab Mx FDG synthesis system.Quality control was studied.RESULTS The corrected radiochemical yield was about 72%, and the chemical purity was above 99% by HPLC.The radiochemical purity was above 95% by TLC.CONCLUSION High-quality 18F-FDG injection prepared in this method is suitable for clinical application in positron emission tromography.
Keywords:18F-FDG  Tracerlab  Synthesis  Quality control  
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