PET显像药物18F-FDG化学合成模块工艺的荟萃分析

Meta-analysis of 18F-FDG chemical synthesis for radiopharmaceuticals used in PET imaging

PET是核医学领域先进的精准医学影像诊疗技术,PET放射性显像药物是实现其精准分子显像的关键,18F-FDG是中国药典唯一收载的PET放射性药物,而化学合成模块工艺又是PET放射性药物品质控制的最关键步骤.本文重点对18F-FDG的化学合成模块工艺和产出药物的品质控制指标进行了荟萃分析,分别从物理、化学和生物学3个方面鉴别,包括:外观、半衰期、放化纯度、放射性浓度、合成效率、细菌内毒素、溶剂残留等指标,对常用的多个合成模块进行了多因素对比解析,以期为临床标准操作规程的广泛应用和药物品质控制的技术普及提供借鉴.

PET is an advanced precision technology for medical imaging in nuclear medicine. PET radiopharmaceuticals are key factors for precise molecular imaging.18F-FDG is presently the only PET radiopharmaceutical written in the China National Pharmacopoeia, its chemical synthesis is the most critical step in quality control. Meta-analysis of 18F-FDG chemical synthesis was done and quality indicators of the final produced drug were compiled. Physical, chemical and biological identifications by physical appearance, half-life, radiochemical purity, radioactivity concentration, synthetic efficiency, bacterial endotoxin and solvent residues were performed and commonly used synthetic modules were analyzed by multi-factor comparison. Reference is provided for wider application of clinical standard operating procedures and popularization of drug quality control technology.