第36卷第1期2023年2月同位素JournalofIsotopesVol.36No.1Feb.2023医疗机构制备氟[18F]脱氧葡糖注射液的质量检验回顾及建议贾娟娟,张文在,弓全胜,孙得洋,施亚琴,黄海伟(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)摘要:回顾分析2016—2021年医疗机构备案制备的氟[18F]脱氧葡糖注射液的质量情况,为提高医疗机构制备氟[18F]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[18F]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。关键词:医疗机构;放射性药品;氟[18F]脱氧葡糖注射液;备案检验;质量中图分类号:TL92+3;R817文献标志码:A文章编号:1000-7512(2023)01-0077-06收稿日期:2022-08-08;修回日期:2022-09-14通信作者:施亚琴,黄海伟doi:10.7538/tws.2022.youxian.065ReviewandSuggestionsonQualityInspectionofFludeoxyglucose[18F]InjectionPreparedbyMedicalInstitutionsJIAJuanjuan,ZHANGWenzai,GONGQuansheng,SUNDeyang,SHIYaqin,HUANGHaiwei(NationalInstitutesforFoodandDrugControl,NMPAKeyLabforQualityResearchandChemicalDrug,Beijing102629,China)Abstract:ThequalityofFludeoxyglucose[18F]injectionpreparedbymedicalinstitu-tionsfrom2016to2021wasreviewed,inordertoprovidereferenceforimprovingthequalitycontrollevelandoperationstandardofFludeoxyglucose[18F]injectionpreparedbymedicalinstitutions.AccordingtotheresultsanalyzedbytheChinesePharmacopoeiafrom123batchesofFludeoxyglucose[18F]injectionpreparedby38medicalinstitutions,theunqualifiedrateoftheproductswas14.6%,andtheunqualifieditemsweremainlyduetopHvalueandresidualsolvents.Byanalyzingthecauses,preparationandqualitycontrolprocessofthesamples,itisconsideredthatthemainreasonisthelackofqualitycontrolawarenessoftheproductionunit,andalsothereareproblemssuchasincompletequalitycontrolinspectionitemsandnonstandardinspectionoperationsoftheproductionunit.Itissuggestedthatmedicalinstitutionsshouldstrengthenthecapabilitybu...
