Jensen Svend B, Nielsen Karin M, Mewis Dennis, Kaufmann Jens
Department of Nuclear Medicine, University Hospital, Aalborg, Denmark.
Nucl Med Commun. 2013 Aug;34(8):806-12. doi: 10.1097/MNM.0b013e328363142f.
The imaging of infectious and inflammatory diseases using gallium-67 (⁶⁷Ga) citrate scintigraphy has been a well-established diagnostic tool for decades. In recent times, interest has focused on PET using the short-lived positron emitting radioisotope ⁶⁸Ga. ⁶⁸Ga is not only more readily available, it also provides better quality images whose high resolution permits quantitative analyses, thus improving the management of patients suffering from infections or inflammation. The purpose of our study was to develop a fast and reliable synthesis protocol for the preparation of ⁶⁸Ga citrate under good manufacturing practice aspects without the use of organic solvents. A commercially available synthesis module was used to perform 10 syntheses with an average yield of 768 ± 31 MBq (mean ± SD) within 10 min; 92.04 ± 1.23% of the radioactivity was located in the product vial, and the rest on the cation exchange cartridge (7.48 ± 1.23%) and in the waste vial (0.47 ± 0.28%). The radiochemical purity of the product determined by instant thin-layer chromatography was greater than 99%. The products have been proven to be sterile and pyrogen-free. Variations were made in several critical synthesis parameters, and the results are presented herein. By eliminating the use of organic solvents, the previously required quality control testing of the final product by gas chromatography can be abandoned. This novel, high-yielding method allows for a more efficient synthesis of ⁶⁸Ga citrate with both shorter production time and high radiochemical purity.
几十年来，使用枸橼酸镓-67（⁶⁷Ga）闪烁扫描术对感染性和炎性疾病进行成像一直是一种成熟的诊断工具。近年来，人们的兴趣集中在使用短寿命正电子发射放射性同位素⁶⁸Ga的PET上。⁶⁸Ga不仅更容易获得，还能提供质量更好的图像，其高分辨率允许进行定量分析，从而改善对感染或炎症患者的管理。我们研究的目的是在良好生产规范方面，开发一种不使用有机溶剂制备⁶⁸Ga枸橼酸盐的快速可靠的合成方案。使用一个市售的合成模块在10分钟内进行了10次合成，平均产率为768±31 MBq（平均值±标准差）；92.04±1.23%的放射性位于产品瓶中，其余的在阳离子交换柱（7.48±1.23%）和废物瓶（0.47±0.28%）中。通过即时薄层色谱法测定的产品放射化学纯度大于99%。已证明产品无菌且无热原。对几个关键合成参数进行了变化，并在此展示结果。通过消除有机溶剂的使用，可以放弃以前对最终产品进行气相色谱质量控制测试的要求。这种新颖的高产方法允许更高效地合成⁶⁸Ga枸橼酸盐，生产时间更短且放射化学纯度高。
