摘要
目的探讨不同测量方法及不同规格载体对放射化学纯度分析的影响。方法以《中国药典》(ChP2020)和^(99)Tc^(m)配套药盒说明书收录的放射化学纯度测定方法为依据,选取临床最为常用的Na^(99)Tc^(m)O_(4)注射液、^(99)Tc^(m)-DTPA注射液、^(99)Tc^(m)-MAA注射液、^(99)Tc^(m)-PHY注射液为研究对象,分别进行两种规格(8mm×9cm和1cm×14cm)载体和两种测量方法(放射性薄层色谱扫描仪和γ计数器)测量的放射化学纯度结果进行比较分析。结果^(99)Tc^(m)-DTPA注射液、^(99)Tc^(m)-MAA注射液、^(99)Tc^(m)-PHY注射液采用9cm载体,以放射性薄层色谱扫描仪测量其放射化学纯度值优于采用14cm载体测量的放射化学纯度值(P<0.05);Na^(99)Tc^(m)O_(4)注射液采用9cm载体和14cm载体,以放射性薄层色谱扫描仪测量其放射化学纯度值差异无统计学意义(P>0.05)。^(99)Tc^(m)-DTPA注射液、^(99)Tc^(m)-MAA注射液、^(99)Tc^(m)-PHY注射液采用14cm规格载体,以γ计数器和放射性薄层色谱扫描仪测量其放射化学纯度值差异有统计学意义(P<0.05),Na^(99)Tc^(m)O_(4)注射液以γ计数器和放射性薄层色谱扫描仪测量其放射化学纯度值差异无统计学意义(P>0.05)。结论Na^(99)Tc^(m)O_(4)、^(99)Tc^(m)-DTPA、^(99)Tc^(m)-MAA、^(99)Tc^(m)-PHY以γ计数器和放射性薄层色谱扫描仪测量其放射化学纯度采用9cm载体优于14cm,放射性薄层色谱扫描仪可作首选仪器,γ计数器作为辅助仪器。
Objective To investigate the impact of different measurement methods and different specifications of carriers on results of radiochemical purity analysis.Methods Based on the radiochemical purity determination methods included in the Chinese Pharmacopoeia(ChP2020)and the instructions for the ^(99)Tc^(m) kit,the most commonly clinically used Na^(99)Tc^(m)O_(4) injection,^(99)Tc^(m)-DTPA injection,^(99)Tc^(m)-MAA injection,and ^(99)Tc^(m)-PHY injection solutions were selected as the research subjects.Two specifications(8 mm×9 cm and 1cm×14cm)of carriers and two measurement methods(radioactive thin layer chromatography scanner andγCompare)were used to analyze the radiochemical purity results measured by the counter.Results The radiochemical purity values of ^(99)Tc^(m)-DTPA injection,^(99)Tc^(m)-MAA injection,and ^(99)Tc^(m)-PHY injection measured with a 9cm carrier using a radioactive thin layer chromatography scanner were better than those measured with a 14cm carrier(P<0.05);The difference in radiochemical purity values between Na^(99)Tc^(m)O_(4) injection with a 9cm carrier and a 14cm carrier measured using a radioactive thin layer chromatography scanner was not statistically significant(P>0.05).^(99)Tc^(m)-DTPA injection,^(99)Tc^(m)-MAA injection,and ^(99)Tc^(m)-PHY injection with a 14cm specification carrierγshowed a statistically significant difference(P<0.05)in the radiochemical purity values measured by a counter and a radioactive thin-layer chromatography scanner.There was no significant difference for Na^(99)Tc^(m)O_(4) injection withγin the radiochemical purity values measured by the counter and the radioactive thin-layer chromatography scanner(P>0.05).Conclusion Na^(99)Tc^(m)O_(4),^(99)Tc^(m)-DTPA,^(99)Tc^(m)-MAA,^(99)Tc^(m)-PHYγcounters and radioactive thin layer chromatography scanners are used to measure their radiochemical purity with a 9cm carrier,which is better than 14cm carrier.Radioactive thin layer chromatography scanners can be the preferred instrument,γcounter can serve as an auxiliar
作者
张月敏
刘岩
许惠
任晓勇
程燕青
杨爱民
ZHANG Yuemin;LIU Yan;XU Hui;REN Xiaoyong;CHENG Yanqing;YANG Aimin(Department of Nuclear Medicine,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China)
出处
《标记免疫分析与临床》
CAS
2024年第2期355-359,共5页
Labeled Immunoassays and Clinical Medicine
关键词
放射化学纯度
放射性薄层色谱扫描仪
γ计数器
纸色谱法
薄层色谱法
Radiochemistry purity
Radioactive thin layer chromatography scanner
γCounter
Paper chromatography
Thin-layer chromatography
