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Rapid Detection of Bacterial Endotoxin Content in 18F-FDG Injection

FU Hua-ping1;ZHANG Xiao-jun1;HE Yu-lin2;ZHANG Jin-ming1   

  1. 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
  • Online:2017-02-20 Published:2017-03-06

18F-FDG注射液细菌内毒素含量的快速检测

付华平1;张晓军1;何玉林2;张锦明1   

  1. 1.中国人民解放军总医院 核医学科,北京100853;2.内蒙古医科大学附属医院 核医学科,呼和浩特010050

Abstract:

The American Endosafe-PTS detector of bacterial endotoxin was used to detecte 8F-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 radiodose of 18F-FDG indicated that radiactive rays had no impacts on the content of bacterial endotoxin. The results reveal that PTS-based detection of bacterial endotoxin content is a rapid and effective approach for 18F-FDG injection.

Key words: 18F-FDG, Endosafe-PTS, bacterial endotoxin

摘要:

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5 EU/mL,低于《中国药典》规定的18F-FDG内毒素含量15 EU/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。

关键词: 18F-FDG, PTS检测仪, 细菌内毒素