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18氟-脱氧葡萄糖合成失败原因分析

     

摘要

Objective 18F-fluorodexoxyglucose ( F-FDG ) is one of the most commonly used PET drugs, and currently little is known about the factors influencing the synthesis of 18F-FDG. This study aims to investigate the influencing factors, and to elevate the yield and success rate of the synthesis of F-FDG. Methods We collected the data of failed syntheses of F-FDG from January 2009 to December 2010, and analyzed the causes of the failures. Results Totally we performed 1257 syntheses of18 F-FDG and succeeded in 1228, with a success rate of 97. 7% and an average yield of 60. 5% . We failed in the other 29 syntheses, with a success rate of 2. 3% and a mean yield of less than 40% . Four times the 18F ion failed to be rinsed into the reactor, with incomplete closure of the pinch valve; twice the waste water was blown into the K222 vial; 7 times the heater of the synthesizing module was broken; 8 times the content of K222 in the FDG kit was below the standard; 6 times the reagents were mistakenly added; and twice the purity of mannose triflate was reduced because of improper preservation. The failures were mainly attributed to the factors related with the stability of the facility, temperature and reagents. Conclusion The yield and success rate of the synthesis of 18F-FDG could be raised through proper maintenance of the facility, standard operation and rigorous working attitude.%目的 18氟-脱氧葡萄糖(18F-fluorodexoxy glucose,18F-FDG )是最常用的正电子药物.对影响18F-FDG合成因素的报道尚不多.文中分析影响18F-FDG合成的因素,以期提高18F-FDG的合成效率和成功率.方法 统计2009年1月至2010年12月合成18F-FDG失败次数,总结分析失败的原因.结果共合成18F-FDG 1257次,成功1228次,平均合成效率为60.5%,成功率为97.7%.未能合成出18F-FDG及合成效率不足40%的情况合计29次,占2.3%.其中18F离子未淋洗至反应管4次;传18F离子管路2位4通阀无法完全闭合,废水进入K222瓶中2次;加热器故障7次;合成时试剂加入错误6次;厂家配套试剂盒中K222含量偏低8次;试剂保存不当,导致三氟甘露糖纯度减低2次.失败原因主要与设备的稳定性、温度、试剂等因素有关.结论注重设备的日常维护及保养、规范的技术操作、严谨的工作态度和工作人员的全面培训可提高药物合成的效率及成功率.

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