锝( ^(99)Tc^(m))二巯丁二酸盐注射液放射化学纯度测定方法的研究  

A Study of the Radiochemical Purity Determination Methodfor ^(99)Tc^(m)-DMSA Injection

作　　者：贾娟娟[1] 张文在 孙得洋 施亚琴[1] 黄海伟[1] JIA Juanjuan;ZHANG Wenzai;SUN Deyang;SHI Yaqin;HUANG Haiwei(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《标记免疫分析与临床》2024年第11期2024-2029,共6页Labeled Immunoassays and Clinical Medicine

基　　金：国家药典委员会药品标准制修订研究课题(编号:2016296)。

摘　　要：目的建立锝(^(99)Tc^(m))二巯丁二酸盐注射液放射化学纯度分析方法。方法考察EP、USP及我国现行标准中放射化学纯度测定方法的专属性。通过优化固定相和展开剂,分析各色谱条件下的峰型、专属性、展开时间等因素,拟定放射化学纯度测定方法,进行分析方法验证。结果现行方法存在专属性不足、峰型拖尾、展开时间长等问题。经色谱条件优化,建立了双系统测定方法,以ITLC-SG为固定相,丁酮和0.3mol/L盐酸饱和的正丁醇为展开剂,通过测定丁酮体系中高锝(^(99)Tc^(m))酸盐(R f值1.0)的含量、正丁醇体系中还原水解锝(R f为0.0)的含量,计算本品的放射化学纯度。结论本研究建立的方法可用于锝(^(99)Tc^(m))二巯丁二酸盐注射液放射化学纯度的测定。Objective To establish a radiochemical purity determination method for ^(99)Tc^(m)-DMSA injection.Methods We examined the specificity of radiochemical purity determination methods with EP,USP and current standards which are currently used in China.By optimizing the stationary phase and developing agents,we analyze peak shape,specificity,development duration and other related factors under various chromatographic conditions.Through this process,a radiochemical purity determination method was developed and the analytical method was validated.Results The current methods suffered issues such as insufficient specificity,peak tailing,and long development duration.After chromatographic conditions were optimized,a dual-system determination method was established.ITLC-SG was used as the stationary phase,while butanone and n-butanol saturated with 0.3 mol/L and hydrochloric acid was used as developing solvent.The radiochemical purity of ^(99)Tc^(m)-DMSA was calculated based on the content of pertechnetate(^(99)Tc^(m))ion in the butanone system(R f value 1.0)and reduced hydrolyzed technetium(R f value 0.0)in the n-butanol system.Conclusion The method established in this study can be used to determine the radiochemical purity of ^(99)Tc^(m)-DMSA injection.

关 键 词：锝(^(99)Tc^(m))二巯丁二酸盐 放射性药品 放射化学纯度 注射液 

分 类 号：O615[理学—无机化学]