^(18)F-雌二醇的质量控制研究  

Quality control of ^(18)F-fluoroestradiol for positron emission tomography

作　　者：袁慧瑜[1,2,3,4,5] 许晓平[1,2,3,4,5] 张勇平 王明伟[1,2,3,4,5] 杨忠毅[1,2,3,4,5] 何思敏 张建平[1,2,3,4,5] 鲍晓 章英剑[1,2,3,4,5] 

机构地区：[1]复旦大学附属肿瘤医院核医学科 [2]复旦大学上海医学院肿瘤学系,上海200032 [3]上海市质子重离子医院核医学科,上海201321 [4]复旦大学生物医学影像研究中心,上海200032 [5]上海分子影像探针工程技术研究中心(筹),上海200032

出　　处：《肿瘤影像学》2015年第3期190-195,共6页Oncoradiology

基　　金：上海市科学技术委员会科技支撑项目(No:12431900208);上海分子影像探针工程技术研究中心项目(No:14DZ2251400)

摘　　要：目的:研究18F-雌二醇(18F-FES)的质量分析方法以完善质量控制操作规范。方法:采用SIEMENS公司Eclipse ST加速器和Explora GN/LC模块,制备18F-FES,根据《中华人民共和国药典》和具体实践研究质量分析方法。结果:按18F-FES合成标准操作规程,其校正后放射化学产率为38%,终产品的各项质量指标符合临床检查要求。结论:本研究中18F-FES质量控制方法和结果能保证临床用药安全。Objective: To study the quality control of 18F-fluoroestradiol(18F-FES), and to establish the standard operation procedure(SOP) and quality criteria. Methods: 18F-FES was synthesized by SIEMENS Eclipse ST cyclotron and Explora GN/LC synthetic system. The contents and methods of quality control for 18F-FES were investigated, and the quality parameters were determined with standard procedure. Results: The SOP of 18F-FES synthesis was established, the corrected radiochemical yield was about 38%. The quality control methods and quality criteria were established according to Chinese Pharmacopoeia based on practice, and all quality parameters met the requirements. Conclusion: The methods and results of quality control of 18F-FES could ensure the drug safety for clinical PET imaging.

关 键 词：18F-氟雌二醇 质量控制 标准 

分 类 号：R817.91[医药卫生—影像医学与核医学]