气相色谱法测量正电子放射性药物中有机溶剂残留及原因分析  

Analysis of Residual Solvents in PET Radiopharmaceuticals by GC

作　　者：李云钢[1] 张晓军[1] 刘健[1] 田嘉禾[1] 张锦明[1] 

机构地区：[1]中国人民解放军总医院核医学科,北京100853

出　　处：《同位素》2013年第3期152-157,共6页Journal of Isotopes

基　　金：北京市自然科学基金(7122162);吴阶平医学基金资助(320.6750.08054)

摘　　要：采用气相色谱法定量分析正电子放射性药物中乙腈、乙醇、N,N二甲基乙醇胺及二甲亚砜(DMSO)的含量,并分析残留原因。以AT-624型毛细管柱作为分离柱,建立了乙腈和乙醇定量范围为:0.004～0.320g/L,N,N二甲基乙醇胺和DMSO为0.010～0.120g/L的标准曲线,使用该曲线分析常规的6～9批正电子药物中有机溶剂残留。结果显示:乙腈和乙醇定量的线性系数分别为0.999 4、0.999 9,N,N二甲基乙醇胺和DMSO的线性系数分别为0.999 7、0.999 6,系统回收率和精密度均符合要求。常规制备的18 F-FDG、18F-FLT、11 C-CFT和11 C-PIB中乙腈残留量分别为(0.031 3±0.043 3)、(0.082 9±0.066 8)、(0.015 6±0.005 9)、(0.025 4±0.026 6)g/L;18F-FDG中乙醇残留为(0.050 5±0.052 8)g/L;18 F-W372和11 C-DT-BZ中DMSO残留分别为(0.033 1±0.018 0)、(0.023 8±0.010 0)g/L,11 C-胆碱中含N,N二甲基乙醇胺为(0.034 8±0.002 2)g/L,均低于美国药典要求。以上结果表明,气相色谱法适用于正电子放射性药物中有机溶剂残留量的快速的分析。The residual solvents in PET radiopharmaceuticals were analyzed by GC, which were acetonitrile, ethanol, N, N-dimethylethanolamine （DMEA）, dimethylsulfoxide （DM- SO）. The standard curves were established with the AT-624 capillary column at GC, and the sensitivity of cetonitrile and ethanol were 0. 004-0. 320 g/L and 0. 010-0. 120 g/L re- spectively. The residual solvents of acetonitrile, ethanol, DMEA and DMSO in PET radio- pharmaceuticals were analyzed by GC. The linearity were 0. 999 4,0. 999 9 ,0. 999 7 ,0. 999 6 respectively. The residual of acetonitrile were （0. 031 3±0. 043 3）,（0. 082 9±0. 066 8）, （0. 015 6±0. 005 9） -（0. 025 4±0. 026 6） g/L in 18F-FDG, 18F-FLT, ^11C-CFT, ^11C-PIB respectively. The residual of ethanol was （0. 050 5±0. 005 28） g/L in 18F-FDG. The residual of DMSO were （0. 033 1±0.018 0） g/L, （0. 023 8±0. 010 0） g/L in 18F-W372 and 11C-DT- BZ respectively. The residual of DMEA was （0. 034 8±0. 002 2） g/L in 11C-Choline. The survived of organic solvent in PET radiopharmaeeuticals can be analyzed with GC directly. The results showed that the QC should be done in PET radiopharmaceuticals purity with semi-HPLC to avoid the high residual .

关 键 词：正电子放射性药物 气相色谱法(GC) 有机残留量 

分 类 号：TQ463[化学工程—制药化工] O657.7[理学—分析化学]