骨显像剂18F-NaF的放射化学制备及其质量控制  

Preparation and Quality Control of 18F-NaF as Bone Imaging Agent

作　　者：范文博[1] Fan Wenbo(Department of Nuclear Medicine & PET centre, The First Affiliated Hospital of Xiamen University, Xiamen 361003, China)

机构地区：[1]厦门大学附属第一医院核医学科PET中心

出　　处：《广东化工》2019年第19期83-84,共2页Guangdong Chemical Industry

摘　　要：研究了骨显像剂18F-NaF注射液的合成方法,并进行了这种骨显像剂的质控和稳定性分析。利用MINItrace医用回旋加速器通过核化学反应18O(p,n)18F生产出18F离子,采用35μA的质子束流连续轰击18O-H2O60min后,18F-F-的平均产额(EOS)为900GBq;用离子交换合成得到18F-NaF,经直接处理法制备18F-NaF注射液。结果表明,18F-NaF注射液的放射性浓度均大于74.0GBq/mL,产物经Radio-HPLC测定,放化纯度>95%;各项检验结果均符合质控要求,常温放置6h所有检验结果均无明显变化。18F-NaF注射液符合临床要求,直接处理法是简单有效的制备方法,制备18F-NaF注射液生物性能稳定、安全。To study the synthetic methods and quality control of [fluorine-18]sodium fluoride (18F-NaF). 18F-NaF was produced by the 18O(p,n) 18F reaction from target irradiated with 16.5 MeV proton at 35 μA for 60 min and using the direct method. Over 95 % of radiochemical purity was determined by Radio-HPLC. 18F-NaF injection was prepared,and the quality control and stability were studied. The results show that the production of 18F-NaF is more than 900 GBq, all of the test results conform to the requirements of the quality control,and the test results are no significant changes under the conditions of 25℃ for 6 h. The results suggust that the direct method is a simple and rapid means for the preparation of 18F-NaF injection. The skeletal PET imaging with 18F-NaF had low background and interferes. 18F-NaF was an excellent bone imaging agent and suitable for clinical skeletal blood flow and bone metabolism measurement. PET imaging with18F-NaF is better at 90 min after injection.

关 键 词：18F-NaF 骨显像剂 质量控制 

分 类 号：TQ[化学工程]