摘要
^(103)Pd通常用于放射性近距离照射治疗,特别在前列腺癌治疗和脉络膜黑色素瘤治疗方面应用较为普遍。目前,^(103)Pd主要的制备方式为加速器辐照铑靶材,经萃取或离子交换树脂分离纯化得到。本研究以非放射性模拟样品对比研究AG 1-X 8和AG MP-1两种阴离子树脂在不同的样品盐酸浓度、淋洗程序、解吸液等条件下对Pd元素的分离纯化效果。经过条件优化,以AG 1-X 8为纯化树脂,通过使用6 mol/L HCl和0.03 mol/L HCl交替淋洗树脂的方式除去Rh基体及其他杂质元素。以1 mol/L氨水与1 mol/L氯化铵1∶1混合溶液解吸Pd时,Pd的回收率约100%,解吸液中Pd/Rh达到最大值,分离效果最佳。以此方法完成3批次加速器辐照铑靶材的分离纯化,^(103)Pd样品的放射性浓度>6 GBq/mL、比活度>800 GBq/mg(分离结束时,EOS)、放射性核纯度>99.9%。依据《中国药典》2020版对检测方法的要求,对放射性核纯度、Pd元素含量分析方法的专属性、检测限和定量限、线性范围、精密度、准确度进行了方法学验证,保证检测结果的准确性及可靠性。
^(103)Pd is commonly used in brachytherapy,especially in the aspect of prostate cancer and choroidal melanoma treatment.At present,^(103)Pd is mainly produced by proton bombardment of rhodium target by cyclotron,and purified by extraction or ion exchange resin.In this work,the separation effects of AG 1-X 8 and AG MP-1 anionic resins were compared by using simulated samples under different chemical procedures,including such as hydrochloric acid concentrations of samples,elution methods,composition of desorption solutions.Under the optimized condition,using AG 1-X 8 resin,Rh matrix and other metal impurities are eluted by 6 mol/L HCl and 0.03 mol/L HCl.Pd is desorbed by mixing 1 mol/L ammonia and 1 mol/L ammonium chloride in equal volume,the recovery of Pd is nearly 100%,and the product has the largest Pd/Rh ratio.By this method,three batches of ^(103)Pd were produced,and the radioactive concentration,specific activity and radionuclide purity of ^(103)Pd were greater than 6 GBq/mL,800 GBq/mg(EOS)and 99.9%,respectively.According to the requirements of the 2020 edition of the Chinese Pharmacopoeia for detection methods,the methodological validation of the analytical methods for the purity of radionuclide and the content of Pd elements was carried out in terms of exclusivity,limit of detection and limit of quantification,linearity,precision and accuracy,to ensure the accuracy and reliability of the test results.
作者
王晓明
段菲
马承伟
褚浩淼
李光
王春林
王成志
温凯
WANG Xiaoming;DUAN Fei;MA Chengwei;CHU Haomiao;LI Guang;WANG Chunlin;WANG Chengzhi;WEN Kai(HTA Co.,Ltd,Beijing 102413,China;CAEA Center of Excellence on Nuclear Technology Applications for Engineering and Industrialization of Radiopharmaceuticals,Beijing 102413,China;CNNC Engineering Research Center of Radiopharmaceuticals,Beijing 102413,China)
出处
《同位素》
CAS
2023年第6期612-619,共8页
Journal of Isotopes
基金
中核集团“青年英才”项目。
