
浏览全部资源
扫码关注微信
西南医科大学附属医院核医学科,泸州,646000
纸质出版日期:2021,
网络出版日期:2021-9-20,
扫 描 看 全 文
赵, 岩, 孙占良, 等. 68Ga-DOTATATE合成问题排查研究[J]. 西南医科大学学报, 2021,44(5):576-583.
Study of problem checking in the radiosynthesis of 68Ga-DOTATATE[J]. Journal of Southwest Medical University, 2021,44(5):576-583.
赵, 岩, 孙占良, 等. 68Ga-DOTATATE合成问题排查研究[J]. 西南医科大学学报, 2021,44(5):576-583. DOI: 10.3969/j.issn.2096-3351.2021.05.024.
Study of problem checking in the radiosynthesis of 68Ga-DOTATATE[J]. Journal of Southwest Medical University, 2021,44(5):576-583. DOI: 10.3969/j.issn.2096-3351.2021.05.024.
目的进行68Ga-DOTATATE标记合成中的问题排查,恢复该放射性药物合成反应的标记率和产品液放射化学纯度。方法在标记率出现异常的情况下,逐一对相关的项目进行检查,包括反应液的pH、缓冲液、前体浓度、反应时间和加热系统。在不同的条件下,使用放射性高效液相色谱仪检查该药物合成反应的放射化学标记率,研究改变不同的参数对标记率的影响。结果经过系统的排查,发现pH、缓冲液、前体浓度、反应时间都在正常的范围内,没有造成标记率异常。而通过使用恒温混匀仪,放射合成反应的标记率可以得到部分或者完全的恢复,但是,在使用恒温混匀仪手动标记时,仍然会出现标记异常的结果,在对66模块与恒温混匀仪的测试中,发现使用模块标记恢复了正常。进一步对实验结果进行总结,推测出问题的来源可能是淋洗锗镓发生器的盐酸在操作中被轻度污染,通过规范锗镓发生器的使用,问题得到了完全解决,恢复了使用合成模块生产68Ga-DOTATATE的标记率和产品液放射化学纯度。结论对68Ga-DOTATATE标记合成中出现的问题进行了系统的排查研究,总结经验,提供了一个检查流程,帮助排查问题;同时,提出相应预防措施,可以防止类似问题重复出现。
Objective To check problems in the radiosynthesis of 68Ga-DOTATATE and restore the labeling yield of the reaction and the radiochemical purity of the final product. Methods When the labeling yield of 68Ga-DOTATATE synthesis was found abnormal,all relevant processes were checked,including the pH of reactive solution,buffer solution,precursor concentration,reaction time,and heating system. A radio-high-performance liq⁃uid chromatography was used to measure the labeling yield of 68Ga-DOTATATE synthesis under different conditions and determine the effects of individual parameters on the labeling yield. Results However,there were still abnor⁃mal RCYs occurred even with the shaking incubator. In the test of comparing results from a module and the shaking incubator
it was found unexpectantly that the RCY from the module was restored back to normal. Further investigat⁃ing our experimental results
we concluded that the problem might come from a mild contamination of the hydrochlo⁃ric acid. By executing strict usage guidelines for the Ge-Ga generator
the problem was resolved completely. The RCY of the reaction and the RCP of the final product were restored as 68Ga-DOTATATE was synthesized using a module.Conclusion This systematic investigation of problems in the radiosynthesis of 68Ga-DOTATATE provides a checking protocol to help identify problems,and also provides corresponding preventive measures to avoid repeated occurrence of similar problems.
68Ga-DOTATATE放射性药物标记正电子发射断层扫描质量控制
68Ga-DOTATATERadiopharmaceutical labelingPositron emission tomographyQuality control
0
浏览量
39
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010802024621