Objective Through the transformation of Tracerlab FXC manufactured by GE's multifunctional carbon synthesizer,to achieve a stable and automated synthesis of 11 C-β-CFT,and perform the necessary quality control of 11 C-β-CFT.Methods The device that does not participate in the reaction was reconstruc-ted on the synthesizer.11C-CO2 was used as the starting material to generate 11CH3I with I2 under the ac-tion of the catalyst,and then converted into Triflate-11 CH3 .Finally,the methylation reaction with nor-β-CFT was performed using solid-phase extraction.Then it was separated and purified to obtain 11 C-β-CFT.The quality control of the 11 C-β-CFT injection was performed by character check,pH check,radiochemical purity measure-ment,bacterial endotoxin test,sterility test,and radioactive concentration test.Results 11 C-β-CFT was synthe-sized successively after five times modification.The resulting 11 C-β-CFT injection was a colorless,trans-parent and sterile pyrogen-free solution with a radiochemical purity of>95％.PET imaging was conducted on normal volunteers and Parkinson's disease using prepared 11 C-β-CFT.PET imaging revealed bilateral striatum imaging in normal controls and bilateral striatum asymmetry and reduced uptake in patients with Parkinson's disease.Conclusion The modified system is simple in operation and can safely and rapidly syn-thesize the 11 C-β-CFT.The resulting product has high radiochemical purity and stable yield,which can meet the requirements of clinical application.%目的 通过对GE公司多功能碳合成器Tracerlab FXC进行改造,实现11 C-β-CFT稳定地自动化合成,并对11 C-β-CFT的合成进行了质量控制.方法 改造合成器上不参与反应的装置,以11 CO2为起始原料在催化剂作用下与I2生成11 CH3 I,再转化成Triflate-11 CH3,最后与nor-β-CFT进行甲基化反应,采用固相萃取法分离纯化制得11 C-β-CFT.通过性状检查、p H值检查、放射化学纯度测定、细菌内毒素检查、无菌检查和放射性浓度检查对11 C-β-CFT注射液进行质量控制.结果 经改造后连续5次合成11 C-β-CFT,所得11 C-β-CFT注射液为无色透明的无菌无热原的溶液,其放射化学纯度>95％,均符合规定.用制备的11 C-β-CFT对正常志愿者与帕金森患者进行PET显像,PET显像显示正常对照者双侧纹状体显像清晰,帕金森病患者双侧纹状体不对称性和摄取性降低.结论 系统改造后操作简单,可安全、快速地合成11 C-β-CFT,所得产品放化纯度高,产率稳定,可满足临床应用要求.
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