锝[^(99m)Tc]放射性药品注射用配套药盒中Sn(II)含量测定方法概述

Overview of the Methods for Determination of Sn(II)in Technetium[^(99m)Tc]Radiopharmaceutical Injection Kits

氯化亚锡的含量是锝[^(99m)Tc]放射性药品注射用配套药盒质量控制的重要指标之一,直接影响锝[^(99m)Tc]放射性药品的临床使用效果,选择合适的分析方法对其进行准确测定至关重要。通过对比《中国药典》2020年版收录的放射性药品质量标准以及相关文献资料,对常用的氯化亚锡含量测定方法包括电位分析法、分光光度法、高效液相色谱法等的特点、测定原理以及应用进行分析总结,可为建立更科学、合理的锝[^(99m)Tc]放射性药品注射用配套药盒质量标准提供技术参考。

The content of stannous chloride is one of the key indicators for the quality control of Technetium[^(99m)Tc]radiopharmaceutical injection Kits,which directly affects the clinical use of Technetium[^(99m)Tc]radiopharmaceuticals.Consequently,it is crucial to choose the appropriate analytical method for its accurate determination.By comparing the quality standards of radiopharmaceuticals included in the 2020 edition of the Chinese Pharmacopoeia and other related literature,the characteristics,determination principles and applications of commonly used methods for the determination of stannous chloride,including potentiometric analysis,spectrophotometry and high-performance liquid chromatography,were analyzed and summarized.This work provided technical reference for the establishment of a more scientific and rational quality standard for Technetium[^(99m)Tc]radiopharmaceutical injection kits.