^(131)I-SAP的制备及应用安全性研究  

Preparation of ^(131)I-SAP and Evaluation of Its Safety for Further Clinical Application

作　　者：魏海亮[1] 闫平[2] 张建华[2] 刘萌[2] 康磊[2] 张丽[3] 郭凤琴[2] 张春丽[2] 王荣福[2] 

机构地区：[1]首都医科大学附属北京世纪坛医院放射科,北京100034 [2]北京大学第一医院核医学科,北京100034 [3]首都医科大学附属北京世纪坛医院核医学科,北京100034

出　　处：《标记免疫分析与临床》2013年第3期179-182,共4页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点基础研究发展计划基金-973计划(编号2006CB705705);国家自然科学基金(编号30870729;30900374);北京大学第一医院青年基金(编号2008-20)资助

摘　　要：目的探讨一种新型淀粉样变性诊断标记物131I-SAP的制备方法及其应用安全性。方法应用Iodogen法对SAP标准品进行131I标记;纸层析法测定131I-SAP的标记率与放射化学纯度。将131I-SAP分别于4℃和37℃新鲜人血清中0h,24h,48h,72h和96h,测定放射化学纯度,评价其体外稳定性。对131I-SAP进行热原、异常毒性等安全性实验。结果131I-SAP的标记率为70.6%,96h后的放射化学纯度仍大于90%。热原、异常毒性实验均为阴性。结论131I-SAP具有较好的体外稳定性,并且无热原及明显毒性反应,适合进一步临床实验及应用的安全性。Objective To prepare a novel imaging agent of 131I-SAP targeting amyloidosis,and evaluate its security for further clinical application.Methods Standard sample of SAP was radiolabeled with 131I by Iodogen method.The labeling efficiency and radiochemical purity of 131I-SAP were calculated by the paper chromatography.The in vitro stability of 131I-SAP under different conditions（4 ℃ and 37℃） were determined at 0,24,48,72 and 96 h respectively.Pyrogen and toxicity tests were also performed.Results The labeling efficiencies of 131I-SAP reached 70.6%,and the radiochemical purity was above 90% at 96 hours.The safety experiments showed that 131I-SAP was free of pyrogen and toxicity.Conclusion 131I-SAP is stable in vitro,and free of pyrogen and toxicity,which may be suitable for further clinical application.

关 键 词：淀粉样变性 血清淀粉样P成分 131碘 热原 毒性反应 

分 类 号：R817.4[医药卫生—影像医学与核医学]