^(99m)Tc-硫胶体非临床安全性评价  

Nonclinical Safety Evaluation of ^(99m)Tc-sulfur Colloid

作　　者：孙钰林 徐晓敏 黄旭虎 秦祥宇 Sun Yulin;Xu Xiaomin;Huang Xuhu;Qin Xiangyu(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：《中外医药研究》2024年第4期3-5,共3页JOURNAL OF CHINESE AND FOREIGN MEDICINE AND PHARMACY RESEARCH

摘　　要：目的:评价^(99m)Tc-硫胶体的非临床安全性.方法:采用皮下刺激性实验、溶血性实验观察^(99m)Tc-硫胶体对新西兰兔刺激性反应及溶血的影响,采用主动过敏性实验观察^(99m)Tc-硫胶体对豚鼠过敏反应的影响.结果:皮下刺激性实验结果显示,^(99m)Tc-硫胶体给药期末和恢复期末未见皮下刺激改变;溶血性实验结果显示,无溶血和致红细胞凝聚现象发生;豚鼠过敏性实验评价为阴性.结论:实验动物注射^(99m)Tc-硫胶体后未发生皮下刺激性、溶血性及过敏反应,表明其可用于皮下注射.Objective:To evaluate the nonclinical safety of ^(99m)Tc-sulfur colloid.Methods:The effects of ^(99m)Tc-sulfur colloid on irritation reaction and hemolysis of New Zealand rabbits were observed by subcutaneous irritation test and hemolytic test.The effect of ^(99m)Tc-sulfur colloid on the allergic reaction of guinea pigs was observed by active allergic test.Results:The results of subcutaneous irritation test showed that there was no change of subcutaneous irritation at the end of administration and recovery of ^(99m)Tc-sulfur colloid;the results of hemolytic test showed that no hemolysis and erythrocyte aggregation occurred;the guinea pig allergic test was negative.Conclusion:No subcutaneous irritation,hemolytic and allergic reaction occurred after injection of ^(99m)Tc-sulfur colloid in experimental animals,indicating that it can be used for subcutaneous injection.

关 键 词：^(99m)Tc-硫胶体 非临床安全性 皮下刺激性实验 溶血性实验 过敏性实验 

分 类 号：R965[医药卫生—药理学]