摘要
目的研究基于不同18F-FDG合成工艺的日本住友F300E模块和国产FDG-IT-N多次合成模块合成的18F-FDG的质量是否存在差异。方法分别随机抽取两个模块所合成的18F-FDG样品,按2015版中国药典规定的方法检测其质量。p H值用精密p H试纸测定,放射化学纯度用薄层色谱法(TLC)测定,氨基聚醚(K2. 2. 2)含量用氯铂酸试纸测定,有机溶剂残留用气相色谱法测定。结果 F300E和FDG-IT-N所生产的18F-FDG各项指标均符合2015版中国药典规定。其中p H值约6. 0～6. 5 (标准为5. 0～8. 0),放射化学纯度均保持在99%以上(标准为不低于90%),K2. 2. 2残留均明显低于标准规定的50 g/m L,乙腈平均残留(g/m L)分别约为(0. 014±0. 003)%和(0. 016±0. 003)%,没有统计学差异(P=0. 39)且符合标准(低于0. 041%)。乙醇平均残留(g/m L)分别约为(0. 101±0. 016)%和(0. 023±0. 016)%,F300E明显高于FDG-IT-N (P=0. 000),但都符合标准(低于0. 5%)。两模块合成的18F-FDG均未检测到丙酮残留。结论尽管工艺有所不同,两个模块所合成的18F-FDG质量都符合2015版中国药典标准。
Objective To compare the quality of18 F-FDG synthesized by Sumitomo F300 E module and domestic PET-FDGIT-N modules which used different synthesis progress. Methods18 F-FDG samples synthesized by the two modules were randomly chose and the quality of the18 F-FDG samples was determined according to the method stipulated in the Chinese Pharmacopoeia 2015. The p H values of samples were measured by precision p H test paper. The radiochemical purities of samples were measured by thin layer chromatography. The amino polyether( K2. 2. 2) concentrations chloroplatinic acid indicator strips. The organic solvents concentrations of samples were measured by gas chromatography. Results All indicators of18 FFDG samples synthesized by both Sumitomo F300 E and domestic PET-FDG-IT-N modules fitted the standard of Chinese Pharmacopoeia( version 2015). The p H values of samples were about 6. 0 ~ 6. 5( standard value: 5. 0 ~ 8. 0). The radiochemical purities of all samples were above 99 %( standard value: ≥90 %). The residue of K2. 2. 2 was significantly lower than the standard of 50 g/m L. The average residue of acetonitrile( g/m L) synthesized by the two modules were( 0. 014 ± 0. 003) %and( 0. 016 ± 0. 003 %),respectively,and there was no statistical difference( P = 0. 39) and the standard was below 0.0041%. The average residue of ethanol( g/m L) of samples synthesized by F300 E module was( 0. 101 ± 0. 016) %,which was higher than samples synthesized by PET-FDG-IT-N module( 0. 023 ± 0. 016) %,g/m L,P = 0. 000). However,the ethanol concentrations of all samples were fitted standard( < 0. 5 %). Acetone residues were not detected in all samples. Conclusion Although synthesis processes of the two modules were different,the quality of18 F-FDG synthesized by them fitted the Chinese Pharmacopoeia standard of 2015 edition.
作者
周文珊
邓鹏裔
ZHOU Wenshan;DENG Pengyi(Hubei Provincial Centre of Disease Control and prevention.Department of Nuclear Medicine,Wuhan 430000 China;The First College of Clinical Medical Science,China Three Gorges University, Yichang Key Laboratory of Nuclear Medicine and Molecular Image)
出处
《中国辐射卫生》
2018年第5期517-520,共4页
Chinese Journal of Radiological Health
