医疗机构制备氟[^(18)F]脱氧葡糖注射液的质量检验回顾及建议  

Review and Suggestions on Quality Inspection of Fludeoxyglucose[^(18)F]Injection Prepared by Medical Institutions

作　　者：贾娟娟[1] 张文在 弓全胜 孙得洋 施亚琴[1] 黄海伟[1] JIA Juanjuan;ZHANG Wenzai;GONG Quansheng;SUN Deyang;SHI Yaqin;HUANG Haiwei(National Institutes for Food and Drug Control,NMPA Key Lab for Quality Research and Chemical Drug,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《同位素》2023年第1期77-82,I0005,共7页Journal of Isotopes

摘　　要：回顾分析2016—2021年医疗机构备案制备的氟[^(18)F]脱氧葡糖注射液的质量情况,为提高医疗机构制备氟[^(18)F]脱氧葡糖注射液的质量控制水平和操作规范性提供参考。按《中国药典》对38家医疗机构制备的123批氟[^(18)F]脱氧葡糖注射液进行质量分析,产品不合格率为14.6%,不合格项目主要为pH和残留溶剂。通过对样品不合格原因、制备及质控过程的分析,认为主要与生产单位质量控制意识不强有关,且存在检验项目不全、检验操作不规范等问题。建议医疗机构加强制备及质量控制能力建设。The quality of Fludeoxyglucose[^(18)F]injection prepared by medical institutions from 2016 to 2021 was reviewed,in order to provide reference for improving the quality control level and operation standard of Fludeoxyglucose[^(18)F]injection prepared by medical institutions.According to the results analyzed by the Chinese Pharmacopoeia from 123 batches of Fludeoxyglucose[^(18)F]injection prepared by 38 medical institutions,the unqualified rate of the products was 14.6%,and the unqualified items were mainly due to pH value and residual solvents.By analyzing the causes,preparation and quality control process of the samples,it is considered that the main reason is the lack of quality control awareness of the production unit,and also there are problems such as incomplete quality control inspection items and nonstandard inspection operations of the production unit.It is suggested that medical institutions should strengthen the capability building of preparation and quality control process.

关 键 词：医疗机构 放射性药品 氟[^(18)F]脱氧葡糖注射液 备案检验 质量 

分 类 号：TL923[核科学技术—核燃料循环与材料] R817[医药卫生—影像医学与核医学]