在符合药品生产质量管理规范（GMP）条件下，实现用于人体的[18F]氟巴汀两种对映体的全自动化放射性合成。
Fully automated radiosynthesis of both enantiomers of [18F]Flubatine under GMP conditions for human application.
作者信息
Patt Marianne, Schildan Andreas, Habermann Bernd, Fischer Steffen, Hiller Achim, Deuther-Conrad Winnie, Wilke Stephan, Smits René, Hoepping Alexander, Wagenknecht Gudrun, Steinbach Jörg, Brust Peter, Sabri Osama
机构信息
Department of Nuclear Medicine, University of Leipzig, Liebigstrasse 18, D-04103 Leipzig, Germany.
出版信息
Appl Radiat Isot. 2013 Oct;80:7-11. doi: 10.1016/j.apradiso.2013.05.009. Epub 2013 Jun 7.
A fully automatized radiosynthesis of (+)- and (-)-[(18)F]Flubatine ((+)- and (-)NCFHEB) by means of a commercially available synthesis module (TRACERlab FX FN) under GMP conditions is reported. Radiochemical yields of 30% within an overall synthesis time of 40 min were achieved in more than 70 individual syntheses. Specific activities were approximately 3000 GBq/μmol and radiochemical purity was determined to be at least 97%.
报道了在GMP条件下，通过市售合成模块（TRACERlab FX FN）对（+）-和（-）-[(18)F]氟巴汀（（+）-和（-）NCFHEB）进行全自动放射性合成。在70多次单独合成中，在40分钟的总合成时间内实现了30%的放射化学产率。比活度约为3000 GBq/μmol，放射化学纯度测定为至少97%。
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