^(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

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.