18F-FDG注射液细菌内毒素含量的快速检测

doi:10.7538/tws.2017.30.01.0043

同位素 ›› 2017, Vol. 30 ›› Issue (1): 43-47.DOI: 10.7538/tws.2017.30.01.0043

• 放射性药物与标记化合物专辑 • 上一篇下一篇

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.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

出版日期:2017-02-20 发布日期:2017-03-06

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

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

Online:2017-02-20 Published:2017-03-06

摘要/Abstract

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

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

付华平;张晓军;何玉林;张锦明. ¹⁸F-FDG注射液细菌内毒素含量的快速检测[J]. 同位素, 2017, 30(1): 43-47.

FU Hua-ping;ZHANG Xiao-jun;HE Yu-lin;ZHANG Jin-ming. Rapid Detection of Bacterial Endotoxin Content in ¹⁸F-FDG Injection[J]. Journal of Isotopes, 2017, 30(1): 43-47.

参考文献

［1］翟士桢，杨志，杜进. ¹⁸F-FDG的放射性标记、显像原理与临床研究进展［J］. 同位素，2011，24（suppl）：59-67.Zhai Shizhen, Yang Zhi,Du Jin. Research progress in radiolabeling, imaging mechanism and clinical applications of ¹⁸F-FDG［J］. Journal of Isotopes, 2011, 24(suppl): 59-67(in Chinese).
［2］国家药典委员会. 《中华人民共和国药典》(2015年版)［M］. 北京：中国医药科技出版社，2015.
［3］吴寒寅，胡大强，陈雅. ¹⁸F-氟脱氧葡萄糖注射液的细菌内毒素检查法［J］. 中国医院药学杂志，2003，23（12）：765-766.Wu Hanyan,Hu Daqiang, Chen Ya. Bacterial endotoxin test of ¹⁸F-fludeoxyglucose injection［J］. Chinese Journal of Hospital Pharmacy, 2003, 23(12): 765-766(in Chinese).
［4］张锦明，李云钢，刘建，等. ¹⁸F-FDG的稳定性及提高稳定性的方法［J］. 同位素，2011，24（2）：89-93.Zhang Jinming, Li Yungang, Liu Jian, et al. Stability and the improved methods of ¹⁸F-FDG［J］. Journal of Isotopes, 2011, 24(2): 89-93(in Chinese).
［5］唐安戊，劳海燕，刘冰，等. 动态比浊法鲎试验定量测定¹⁸F-FDG的细菌内毒素含量［J］. 中华核医学与分子影像杂志,2001，21(4):249-250.Tang Anshu, Lao Haiyan, Liu Bing,et al. Application of the kinetic turbidimetric Limulus test in endotoxin test of a PET imaging agent ¹⁸F-FDG［J］. Chinese Journal of Nuclear Medicine and Molecular Imaging, 2001, 21(4): 249-250(in Chinese).
［6］宋天琪，田子新. 氟¹⁸F脱氧葡糖注射液细菌内毒素检查法的方法学验证［J］. 天津药学，2010,22(1):3-5.Song Tianqi, Tian Zixin. Validation of examination of bacterial endotoxin in fluorine ［¹⁸F］ deoxidized glucose injection［J］. Tianjin Pharmacy, 2010, 22(1): 3-5(in Chinese).
［7］Gee A P, Sumstad D, Stanson J, et al. A multicenter comparison study between the Endosafe PTS rapid-elease testing system and traditional methods for detecting endotoxin in celltherapy products［J］. Cytotherapy, 2008, 10(4): 427-435.

[1]	孙祥敏;骆丹;杜建冬;吴艳丽;张云;郭飞虎. 氟［¹⁸F］化钠注射液细菌内毒素检查及无菌检查方法建立[J]. 同位素, 2020, 33(4): 234-240.
[2]	张卫方;张彦彦;李艳. ¹⁸F-FDG和¹⁸F-NaF示踪剂在大鼠经脉的microPET显像[J]. 同位素, 2017, 30(3): 200-203.
[3]	孙祥敏;张云;张先;杨薇薇;蔡海燕. 碘［¹³¹I］爱克妥昔单抗注射液细菌内毒素检查方法建立[J]. 同位素, 2015, 28(3): 135-139.
[4]	万卫星;薛杨波;王燕;瞿凌晨;许波华;杨敏. 双示踪剂Micro-PET显像评价大鼠心肌缺血模型[J]. 同位素, 2013, 26(4): 216-221.
[5]	鄢敏;秦志星;程鹏亮;李思进;武志芳;刘建中. 采用试剂盒在改进的住友CFN氟多功能模块上合成FDG[J]. 同位素, 2013, 26(3): 175-179.
[6]	赵岩;王晓静;叶肇云;赵秀岩;姜华. 高效液相色谱法测定¹⁸F-FDG注射液中氨基聚醚含量[J]. 同位素, 2012, 25(3): 171-174.
[7]	谢博洽 ;杨敏福 ;叶珏 ;杨子鹤 ;窦克非 ;韩春雷 ;田毅 . ¹⁸F-FDG PET/CT显像对心肌“缺血记忆”的分子机制研究[J]. 同位素, 2012, 25(1): 47-52.
[8]	陆国秀;张彩霞;徐薇娜;于树鹏;辛军. ¹⁸F-FDG PET/CT对恶性胸膜间皮瘤诊断及预后评估的价值[J]. 同位素, 2012, 25(1): 58-63.
[9]	翟士桢 ;杨志 ;杜进 . ¹⁸F-FDG的放射性标记、显像原理与临床研究进展[J]. 同位素, 2011, 24(增刊): 59-67.
[10]	张锦明;李云刚;刘健;张晓军;田嘉禾. ¹⁸F-FDG的稳定性及提高稳定性的方法[J]. 同位素, 2011, 24(2): 89-93.

¹⁸F-FDG注射液细菌内毒素含量的快速检测

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

PDF

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 10

编辑推荐

Metrics