锝[^(99)Tc^(m)]亚甲基二膦酸盐注射液生物分布检验方法研究  

Study on Test Method of Biological Distribution of Technetium[^(99)Tc^(m)]Methylenediphosphonate Injection

作　　者：孙祥敏 邵长芳 李源淼 吴艳丽 杨旭 杨柳 梁塑 王勇 张云 SUN Xiangmin;SHAO Changfang;LI Yuanmiao;WU Yanli;YANG Xu;YANG Liu;LIANG Su;WANG Yong;ZHANG Yun(HTA Co.,Ltd.,Beijing 102413,China)

机构地区：[1]原子高科股份有限公司,北京102413

出　　处：《原子能科学技术》2021年第S01期17-22,共6页Atomic Energy Science and Technology

摘　　要：锝[99Tc^(m)]亚甲基二膦酸盐注射液生物分布检验是确定其有效性的重要指标。本工作对国内不同厂家生产的注射用亚锡亚甲基二膦酸盐药盒标记的锝[99Tc^(m)]亚甲基二膦酸盐注射液进行生物分布检验方法研究,以建立适用于国内锝[99Tc^(m)]亚甲基二膦酸盐注射液检验方法。对注射后解剖时间、注射剂量进行检验条件筛选的结果表明,注射剂量在1.48~74 MBq时,各器官摄取率基本一致;不同厂家药盒标记的锝[99Tc^(m)]亚甲基二膦酸盐注射液在各器官的摄取率在2 h基本达到平衡。通过以上研究建立了锝[99Tc^(m)]亚甲基二膦酸盐注射液检验方法,验证结果表明,该检验方法准确可靠,可作为锝[99Tc^(m)]亚甲基二膦酸盐注射液质量控制指标之一,用于其质量控制。The test of the biological distribution of radiopharmaceutical technetium[99Tc^(m)]methylene diphosphonate injections plays crucial roles in the determination of drug efficacy.In this work,a study of biological distributions regarding the technetium[99Tc^(m)]methylenediphosphonate injections labeled by different domestic manufacturers was performed to establish a test method suitable for the test of domestic technetium[99 Tc m]methylenediphosphonate injections.The test conditions of dissection time and injection dose were screened.The results indicate that the uptake ratios of these technetium[99Tc^(m)]methylenediphosphonate injections at different organs are nearly consistent when the injection doses are ranging from 1.48 MBq to 74 MBq,and would reach equilibrium after two hours.The test method of technetium[99Tc^(m)]methylenediphosphonate injections was established through the above research.The results show that the test method is accurate and reliable,and can be used as one of the quality control indexes of technetium[99Tc^(m)]methylenebisphosphonate injection,and can be used for its quality control.

关 键 词：锝[^(99)Tc^(m)]亚甲基二膦酸盐注射液 放射性药物 生物分布 

分 类 号：R927.11[医药卫生—药学]