[1]张奇洲,李毓斌,李肖红,等.11C-乙酸盐的自动化合成影响因素的考察及质量控制[J].国际放射医学核医学杂志,2016,40(1):6-12.[doi:10.3760/cma.j.issn.1673-4114.2016.01.002]
　Zhang Qizhou,Li Yubin,Li Xiaohong,et al.Study of the automated synthesis influence factors and quality control of 11C-acetate[J].International Journal of Radiation Medicine and Nuclear Medicine,2016,40(1):6-12.[doi:10.3760/cma.j.issn.1673-4114.2016.01.002]
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11C-乙酸盐的自动化合成影响因素的考察及质量控制(/HTML)
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《国际放射医学核医学杂志》[ISSN:1673-4114/CN:12-1381/R]

卷:
40
期数:
2016年第1期
页码:
6-12
栏目:
出版日期:
2016-01-25

文章信息/Info

Title:
Study of the automated synthesis influence factors and quality control of 11C-acetate
作者:
张奇洲;  李毓斌;  李肖红;  秦永德
830011 乌鲁木齐, 新疆医科大学第一附属医院核医学科
Author(s):
Zhang Qizhou;  Li Yubin;  Li Xiaohong;  Qin Yongde
Department of Nuclear Medicine, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, China
关键词:
乙酸盐类; 自动化; 质量控制; 化学合成
Keywords:
Acetates; Automation; Quality Control; Chemical synthesis
DOI:
10.3760/cma.j.issn.1673-4114.2016.01.002
摘要:
目的 通过对Tracerlab FXC进行改造实现稳定地自动化合成11C-乙酸盐,并进行了必要的质量控制及产率的影响因素分析。方法 短接合成器上不参与反应的装置,加装可外部控制的阀门或装置来控制可能影响合成产率的外部因素。以活性11C-CO2与500μl 0.5 mol/L的CH3MgBr反应,经猝灭、稀释、固相萃取获得11C-乙酸盐。参照中国药典第四部通则对终产品进行必要的质量控制。结果 通过产率的影响因素分析明确了显著影响11C-乙酸盐合成的因素。经过连续5次合成11C-乙酸盐,所得产品经检定均符合规定。结论 11C-乙酸盐的合成影响因素多,产率浮动大,采用改造过的这套系统可自动、稳定、快速、安全地合成11C-乙酸盐,并且各项必要的质控指标均符合要求。
Abstract:
Objective To use Tracerlab FXC transformation to achieve a stable automated synthesis of 11C-acetate,while performing necessary quality control and analysis of key factors of production yield.Methods The devices that do not participate were short-circuited in the reaction of synthesis,adding external controllable valves or devices to control the external factors which may affect the synthesis yield.The active 11C-CO2 reacts with 500 μl of 0.5 mol/L methyl magnesium bromide and then quenched and diluted,and solid phase extraction was used to obtain 11C-acetate.Quality control is applied to the final product according to Chinese Pharmacopoeia Fourth General.Results The analysis of the key factors of yield was carried out to identify the major factors exerts the most considerable effect on the processing synthesis of 11C-acetate.All results qualified after testing according to Chinese Pharmacopoeia quality control guidelines with five times of consecutive synthesis.Conclusions Numerous factors affect the synthesis of 11C-acetate,and production yield is highly unstable,as well.The modified Tracerlab FXC is able to produce 11C-acetate in a faster,more stable,and secure approach,and the final product is also qualified according to the product standard.

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备注/Memo

备注/Memo:
收稿日期:2015-08-05;改回日期:。
基金项目:新疆医科大学第一附属医院科研基金(2013ZRQN34)
通讯作者:秦永德
更新日期/Last Update: 1900-01-01