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目的:制备n 89Zr标记达雷妥尤单克隆抗体(Daratumumab)，并评价其用于多发性骨髓瘤(MM)显像诊断的可行性。n 方法:依据n 89Y(p，n)n 89Zr核反应原理，采用回旋加速器固体靶系统(30 μA，1.5 h)和自动化纯化模块生产n 89Zr，检测核纯度、半衰期和杂质金属含量。将去铁胺(DFO)与Daratumumab偶联后再与n 89Zr螯合制备n 89Zr-DFO-Daratumumab，进行连续3批产品的质量控制分析。在正常家兔体内进行药代动力学评价，在原位骨髓瘤小鼠模型中进行n 89Zr-DFO-Daratumumab microPET/CT显像。采用两独立样本n t检验比较原位骨髓瘤和正常骨骼SUV的差异。n 结果:获得n 89Zr纯品约560 MBq，γ能谱仪显示只有2个n 89Zr特征能峰(909 keV和511 keV)，半衰期为78.2 h，金属杂质含量较少。n 89Zr-DFO-Daratumumab的pH值为7.2左右，放化纯大于99%，体外稳定性良好，无菌和内毒素检测通过。家兔体内药代动力学研究显示，随时间推移和体内代谢，n 89Zr-DFO-Daratumumab逐渐由血液分布于肝、脾、肾和骨关节等。原位骨髓瘤小鼠n 89Zr-DFO-Daratumumab microPET/CT显像示，n 89Zr-DFO-Daratumumab在原位骨髓瘤的SUV高于正常骨骼(2 h：0.22±0.02和0.06±0.00；1 d：0.38±0.01和0.08±0.00；n t值：8.89、21.90，均n P＝0.001)。n 结论:成功制备n 89Zr和n 89Zr-DFO-Daratumumab，并完成相关质量控制与体内外生物学评价，验证了n 89Zr-DFO-Daratumumab用于MM显像诊断的可行性，为临床转化打下基础。n “,”Objective:To prepare n 89Zr labeled Daratumumab and evaluate its feasibility in the imaging diagnosis of multiple myeloma (MM).n Methods:According to the principle of n 89Y (p, n) n 89Zr nuclear reaction, n 89Zr was produced by cyclotron solid target system (30 μA, 1.5 h) and automatic purification module. The radionuclide purity, half-life and impurity metal ion concentration were detected. Desferrioxamine (DFO) was coupled with Daratumumab and then chelated with n 89Zr to prepare n 89Zr-DFO-Daratumumab. The quality control analyses of three consecutive batches were carried out. Pharmacokinetic evaluation and n 89Zr-DFO-Daratumumab microPET/CT imaging were performed in normal rabbits and orthotopic myeloma mouse models, respectively. The SUV in situ myeloma and that in normal bone were compared by independent-sample n t test.n Results:About 560 MBq of n 89Zr was obtained, and there were only two characteristic energy peaks of n 89Zr (909 keV and 511 keV) by γ spectrometer. The half-life of n 89Zr was 78.2 h, and the content of metal impurities was small. n 89Zr-DFO-Daratumumab was prepared with pH of 7.2, radiochemical purity of more than 99%, good stability n in vitro, and sterility and endotoxin tests were passed. Pharmacokinetic studies in rabbits showed that n 89Zr-DFO-Daratumumab was gradually distributed from blood to liver, spleen, kidney and bone joints over time and metabolism. The results of microPET/CT imaging in orthotopic myeloma mouse models showed that the SUVs of n 89Zr-DFO-daratumumab in situ myeloma were significantly higher than those in normal bone (2 h: 0.22±0.02 n vs 0.06±0.00; 1 d: 0.38±0.01 n vs 0.08±0.00; n t values: 8.89, 21.90, both n P=0.001).n Conclusion:89Zr and n 89Zr-DFO-daratumumab are successfully prepared, and relevant quality control and biological evaluation n in vivo and n in vitro are completed, which verify the feasibility of n 89Zr-DFO-Daratumumab in the imaging diagnosis of MM, thus laying a foundation for clinical transformation.n