18F-FDG注射液细菌内毒素含量的快速检测

使用美国Endosafe-PTS细菌内毒素快速检测仪检测^18F-FDG注射液细菌内毒素含量,并与传统光度法检测结果进行对比。研究新制备、大剂量的^18F-FDG对细菌内毒素含量的影响。结果显示：PTS检测仪检测内毒素,回收率在50%~200%,小于5EU/mL,低于《中国药典》规定的^18F-FDG内毒素含量15EU/mL;PTS检测结果与传统光度法检测结果均符合《中国药典》要求,表明结果可信;新制备、大剂量的^18F-FDG的检测结果与衰变后溶液检测结果一致,表明放射性对细菌内毒素含量没有影响。PTS检测仪可以作为^18F-FDG细菌内毒素快速检测的有效方法。...

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Bibliographic Details
Published inTong wei su Vol. 30; no. 1; pp. 43 - 47
Main Author 付华平 张晓军 何玉林 张锦明
Format Journal Article
LanguageChinese
Published 中国人民解放军总医院核医学科,北京,100853%内蒙古医科大学附属医院核医学科,呼和浩特,010050 2017
Editorial Board of Journal of Isotopes
Subjects
18F-FDG
PTS检测仪
细菌内毒素
Endosafe-PTS
bacterial endotoxin
18F-FDG
细菌内毒素
PTS检测仪
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ISSN1000-7512
1000-7512
DOI10.7538/tws.2017.30.01.0043

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Summary:使用美国Endosafe-PTS细菌内毒素快速检测仪检测^18F-FDG注射液细菌内毒素含量,并与传统光度法检测结果进行对比。研究新制备、大剂量的^18F-FDG对细菌内毒素含量的影响。结果显示：PTS检测仪检测内毒素,回收率在50%~200%,小于5EU/mL,低于《中国药典》规定的^18F-FDG内毒素含量15EU/mL;PTS检测结果与传统光度法检测结果均符合《中国药典》要求,表明结果可信;新制备、大剂量的^18F-FDG的检测结果与衰变后溶液检测结果一致,表明放射性对细菌内毒素含量没有影响。PTS检测仪可以作为^18F-FDG细菌内毒素快速检测的有效方法。
Bibliography:11-2566/TL
FU Hua-ping1,ZHANG Xiao-jun1,HE Yu-lin2,ZHANG Jin-ming1（1.Department of Nuclear Medicine, The PLA General Hospital, Beijing 100853, China;2.Department of Nuclear Medicine, The Affiliated Hospital of Inner Mongolia Medical University, HoHHot 010050, China ）
The American Endosafe-PTS detector of bacterial endotoxin was used to detecte ^18F-FDG injection, and the results were compared to traditional spectrophotometric determination. Meanwhile, the impacts on the content of bacterial endotoxin caused by new production and high radio-dose of ^18F-FDG was also evaluated by PTS detection. The results showed that recovery rates were about 50% to 200%, detecting contents were smaller than 5 EU/mL, both of which conformed to the rules of ^18F-FDG in Chinese Pharmacopeia. The detecting results were consistent between PTS and traditional spectrophotometric detection, which indicated the trustworthiness and reliability for PTS detecttion. The consistence before and after radiative decay of new production and high
ISSN:1000-7512
1000-7512
DOI:10.7538/tws.2017.30.01.0043