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为了解131I-抗肿瘤人鼠嵌合单克隆抗体(131I-TNT)用于裸小鼠的安全剂量.以提供今后进行药效学研究的剂量范围,将5~6周龄SPF级BALB/c裸小鼠24只,随机分为4组,每组雌雄各3只。前3组为实验组,分别经腹腔注射~(131)I-TNT-TNT22.2、14.8和7.4MBq/只。第4组为对照组,腹腔注射等体积生理盐水。~(131)I-TNT的放射性比活度为3.7X1011Bq/g,放化纯度>95%,免疫活性>75%,标记后24h内使用,标记物经无菌、无热源检查均合格。使用前用含4%人血清白蛋白的生理盐水稀释三所需浓度。注射后分笼饲养,每日观察进食量、体重变化、行为活动等生命活动指标。结果,腹腔注射~(131)I-TNT14.8MBq/只组与7.4MBq/只组,裸鼠活动如常,表皮有光泽,进食量不下降,体重维持在正常水平,各项生命活动指标与对照组相比均无明显差异,且30d内无死亡。~(131)I-TNT22.2MBq/只组1周后进食开始减少,活动迟钝;2周后开始逐个死亡,30d后仅存留2只,且表皮无光泽,体重减轻;由生存率曲线和体重曲线可观察到22.2MBq/只组与其他各组有明显差异。因此,~(131)I-TNT在棵小鼠上14.8MBq/只以下剂量可认为比较安全。
To understand the safe dose of 131I-antineoplastic human chimeric monoclonal antibody (131I-TNT) for nude mice. To provide a dose range for future pharmacodynamic studies, 24 SPF BALB / c nude mice aged 5 to 6 weeks were randomly divided into 4 groups with 3 male and 3 female in each group. The first three groups were experimental group, which were injected intraperitoneally with ~ (131) I-TNT-TNT22.2, 14.8 and 7.4MBq / each. The fourth group is the control group, intraperitoneal injection of equal volume of normal saline. The specific activity of ~ (131) I-TNT was 3.7X1011Bq / g, the radiochemical purity was more than 95% and the immunological activity was more than 75%. The labeled substance was used within 24 hours after labeling. Before use, dilute the three concentrations with physiological saline containing 4% human serum albumin. After injection, the rats were kept in cage, and daily observation of food intake, weight changes, behavioral activities and other indicators of life activities. The results showed that nude mice had normal activity, shiny epidermis, no decrease in food intake, and normal body weight at a mean of 14.8 MBq / group and 131.8 mg / There was no significant difference between the control group and no death within 30 days. ~ (131) I-TNT22.2MBq / 1 week after feeding, the feeding started to decrease and the activity slow; after 2 weeks, it began to die one after the other, only 2 remained after 30 days, and the epidermis was dull and lost weight; The curve shows a significant difference between 22.2 MBq / group and the other groups. Therefore, ~ (131) I-TNT can be considered as safe in mice under 14.8 MBq / dose.