^(11)C-Carfentanil的质量控制  

Quality Control of ^(11)C-Carfentanil

作　　者：张晓军[1] 向晓辉[2] 张锦明[1] 田嘉禾[1] 

机构地区：[1]中国人民解放军总医院核医学科,北京100853 [2]北京大学神经科学研究所,北京100191

出　　处：《同位素》2013年第1期29-32,41,共5页Journal of Isotopes

摘　　要：11 C标记的卡芬太尼(11 C-Carfentanil)中载体(12 C-Carfentanil)的含量对该药物的安全使用至关重要。利用高效液相色谱系统测量11 C-Carfentanil注射液的化学纯度和放化纯度;液质联用方法测量比活度;应用快速内毒素检测器PTS检测产品中内毒素含量。结果表明:合成产品为无色透明澄清11 C-Carfentanil溶液,放化纯度大于98%,比活度为1.69×1014 Bq/g,内毒素含量小于5EU/mL。以上结果表明:11 C-Carfentanil注射液的质量符合药用要求,可满足实验和临床安全使用要求。To study the quality control of 11C-Carfentanil injection,physical,chemical and biological identification were used.The chemical and radiochemical purity of 11C-Carfentanil Injection were detected by HPLC and Flower Count system;measured the quantity of product by LC-MS,specific activity was calculated later;The PTS was used to detect endotoxin,and other quality control methods were put up to guarantee the security of its clinical application.The produce appeared colorless and transparent,the radiochemical purity was more than 98%,content of the endotoxin was less than 5 EU/mL.The result showed that 11C-Carfentanil injection had fulfilled pharmaceutical quality control request and could be applied safely to animal experiment and clinical diagnosis.

关 键 词：11C-Carfentanil 高效液相色谱 液质联用 质量控制 

分 类 号：R817[医药卫生—影像医学与核医学]