^(18)F-FDG配套试剂盒的开发

Development of 18F-FDG Kit

参考国内外药典和药品生产质量管理规范,建立^(18)F-FDG(氟[^(18)F]脱氧葡糖注射液,简称^(18)F-FDG)配套试剂盒的检验项目和质量指标,确立生产工艺和关键控制点,开展试剂盒的稳定性考察。按照上述工艺制备的^(18)F-FDG配套试剂盒用于^(18)F-FDG合成,合成效率为55%~60%之间,合成产品^(18)F-FDG的质量标准符合2015版中国药典标准,满足生产要求。研发的^(18)F-FDG配套试剂盒可用于^(18)F-FDG的日常生产,未来应用会产生好的经济效益。

The paper establishes the ^（18） F-FDG（fluorine [ ^（18） F] deoxy dextrose injection, short for ^（18） F-FDG） by referring to the standard for the quality management of Pharmacopoeia and drug production at home and abroad, test items and quality index of kit, ensures the production technology and key control points, and develops the stable observation of kits. ^（18） F-FDG kit is used in the synthesis of ^（18） F-FDG according to the technology preparation, and the synthesis efficacy is 55%-60%, and the quality standards of synthesis product ^（18） F-FDG is compliance with the 2015 edition of Chinese pharmacopoeia standard and meets the production requirement. The ^（18） F-FDG kit can be used in the daily production of ^（18） F-FDG, and it can produce a better economy benefit in future application.