炎症显像剂^（99m）Tc－HIG一步法药盒的制备和实验研究

DEVELOPMENT OF AN INSTANT ￣(99m)Tc LABELLED HIG KIT FOR LOCALIZATION OF INFECTION/ INFLAMMATION

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．

PURPOSE 99mTc labelled polyclonal human immunoglobulin G (HIG) is a novel agent for detecting infection and in flammation. We report the preparation, quality control, pharmacology and preliminary clinical evaluation of this imaging agent. METHODS After modification of HIG and purification, the HIG kit was formulated and lyofilized. Labelling yield and radiochemical purity were determined by TLC-SG, PC and Sephadex G-50 column chromatography.Animal models for pharmacologic experiments were mice, rats and rabbits. RESULTS The labelling yield was 99%immediately after mixing HIG with 99mTc and more than 90% of radioactivity was retained after keeping the labelled product at room temperature 24 hours post labelling. There were good accumulation and high T/ B ratio in animal models (rats and rabbits bearing turpentine and Staphylococcus aureus induced inflammatory or infectious foci). CONCLUSIONS The results showed that this new agent is nearly ideal for localization of infectious / inflammatory lesions.