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研制一种特异性亲炎症或感染部位的示踪定位显像剂99mTc标记的人多克隆免疫球蛋白G(HIG).方法:用2-亚氨基硫烷修饰HIG,制备冷冻干燥99mTc标记一步法药盒,测定该药盒及其标记产物99mTc-HIG的理化性质、生物性能,初步试用于临床.结果:室温下该药盒经与99mTcO混合后,立即得到标记年大于99%的99mTc-HIG,标记方法简单便利;标记后室温保存24小时,放化纯度仍大于90%,产物稳定性好;在炎症/感染动物模型上,示踪剂定位明确.T/B值高;药盒的各项技术指标符合药典体内诊断试剂的规定.结论:经初步临床试用,诊断价值肯定,特别适合于我国国情.
Development of a 99mTc-labeled human polyclonal immunoglobulin G (HIG) with a specific affinity for inflammation or site of infection. Methods: HIG was modified with 2-iminothiolane to prepare lyophilized 99mTc labeled one-step kit. The physicochemical properties and biological properties of 99mTc-HIG were assayed. The kit was initially tested in clinic. Results: After the kit was mixed with 99mTcO at room temperature, the 99mTc-HIG with the labeling of more than 99% was obtained immediately. The labeling method was simple and convenient. After the labeling was stored at room temperature for 24 hours, the radiochemical purity was still above 90% Tracer localization is well established in an inflammatory / infectious animal model. T / B value is high; the technical indicators of the kit are in accordance with the provisions of the Pharmacopoeia diagnostic reagent in vivo. Conclusion: After preliminary clinical trial, the diagnostic value is affirmative, especially suitable for our national conditions.