肿瘤影像学
腫瘤影像學
종류영상학
Oncoradiology
2015年
3期
190-195
,共6页
袁慧瑜%许晓平%张勇平%王明伟%杨忠毅%何思敏%张建平%鲍晓%章英剑
袁慧瑜%許曉平%張勇平%王明偉%楊忠毅%何思敏%張建平%鮑曉%章英劍
원혜유%허효평%장용평%왕명위%양충의%하사민%장건평%포효%장영검
18F-氟雌二醇%质量控制%标准
18F-氟雌二醇%質量控製%標準
18F-불자이순%질량공제%표준
18F-lfuoroestradiol%Quality control%Criteria
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。
目的：研究18F-雌二醇(18F-FES)的質量分析方法以完善質量控製操作規範。方法：採用SIEMENS公司Eclipse ST加速器和Explora GN/LC模塊，製備18F-FES，根據《中華人民共和國藥典》和具體實踐研究質量分析方法。結果：按18F-FES閤成標準操作規程，其校正後放射化學產率為38%，終產品的各項質量指標符閤臨床檢查要求。結論：本研究中18F-FES質量控製方法和結果能保證臨床用藥安全。
목적：연구18F-자이순(18F-FES)적질량분석방법이완선질량공제조작규범。방법：채용SIEMENS공사Eclipse ST가속기화Explora GN/LC모괴，제비18F-FES，근거《중화인민공화국약전》화구체실천연구질량분석방법。결과：안18F-FES합성표준조작규정，기교정후방사화학산솔위38%，종산품적각항질량지표부합림상검사요구。결론：본연구중18F-FES질량공제방법화결과능보증림상용약안전。
Objective:To study the quality control of18F-lfuoroestradiol (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 for18F-FES were investigated, and the quality parameters were determined with standard procedure.Results:The SOP of18F-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 of18F-FES could ensure the drug safety for clinical PET imaging.
