摘要目的:制备国产 68Ge- 68Ga发生器，通过与进口 68Ge- 68Ga发生器（德国ITG公司）进行对比，对其进行初步应用评价。 方法:制备 68Ge- 68Ga发生器，测定其淋洗后初始时间（0）、1、4、12 h的淋洗产物 68Ga 3+的放射性活度；与进口 68Ge- 68Ga发生器淋洗产物 68Ga 3+的γ能谱及 68Ga 3+在正常小鼠体内的分布情况进行对比；确定国产 68Ge- 68Ga发生器淋洗产物标记前列腺特异性膜抗原（PSMA）-11的最佳标记条件及产物的放射化学纯度；对比国产与进口 68Ge- 68Ga发生器淋洗产物标记的 68Ga-PSMA-11在22Rv1前列腺癌肿瘤模型小鼠体内的分布情况。计量资料的组间比较采用LSD法进行检验。 结果:国产 68Ge- 68Ga发生器在淋洗后初始时间（0）、1、4、12 h的淋洗产物 68Ga 3+的放射性活度分别为125.8、74.0、118.4、111.0 MBq。国产与进口 68Ge- 68Ga发生器淋洗产物 68Ga 3+的γ能谱高度一致，在正常小鼠体内的分布基本没有差异，均在心脏呈现放射性高摄取。国产 68Ge- 68Ga发生器淋洗产物标记PSMA-11的最佳标记条件是pH值4.5，85℃恒温反应15 min，得到的 68Ga-PSMA-11的放射化学纯度>95%。国产与进口 68Ge- 68Ga发生器淋洗产物标记的 68Ga-PSMA-11在22Rv1前列腺癌肿瘤模型小鼠体内的显像结果显示， 68Ga-PSMA-11均在肿瘤部位呈现高摄取，其余主要分布于肾脏和膀胱。国产 68Ge- 68Ga发生器淋洗产物标记的 68Ga-PSMA-11注射后30、60、90 min，肿瘤部位的放射性摄取值均低于进口 68Ge- 68Ga发生器[（3.60±0.14） %ID/g对（5.30±0.42） %ID/g、（3.40±0.12） %ID/g对（5.90±0.36） %ID/g、（2.90±0.28） %ID/g对（5.50±0.33） %ID/g]，且差异均有统计学意义（LSD法，均 P<0.05）。 结论:国产 68Ge- 68Ga发生器淋洗产物 68Ga 3+及其标记的 68Ga-PSMA-11在正常小鼠和肿瘤模型小鼠体内的分布情况与进口 68Ge- 68Ga发生器无明显差异。

abstractsObjective:To prepare a domestically produced 68Ge- 68Ga generator and compare it with an imported 68Ge- 68Ga generator (ITG Company, Germany) for preliminary application evaluation. Methods:A 68Ge- 68Ga generator was prepared, and the radioactivity of its elution product 68Ga 3+ was measured at the initial time (0) and 1, 4, and 12 h after elution. The γ-spectra of the elution product 68Ga 3+ and its distribution in normal mice were compared with those of an imported 68Ge- 68Ga generator. The optimal labeling conditions for prostate-specific membrane antigen (PSMA)-11 labeled by domestic 68Ge- 68Ga generator elution product and the radiochemical purity of the labeled product were determined, and the distribution of 68Ga-PSMA-11 labeled by domestic and imported 68Ge- 68Ga generator elution products in 22Rv1 prostate cancer tumor model mice was compared. The intergroup comparison of measurement data was conducted using the LSD method. Results:The radioactivity values of 68Ga 3+ in the elution product of the domestic 68Ge- 68Ga generator at the initial time (0), 1, 4, and 12 h after elution were 125.8, 74.0, 118.4, and 111.0 MBq, respectively. The γ-spectra of 68Ga 3+ eluted by domestic and imported 68Ge- 68Ga generators were highly consistent, and no difference was observed in the distribution of 68Ga 3+ in normal mice, and both showed high uptake of radioactivity in the heart. The optimal labeling conditions for PSMA-11 labeled by domestic 68Ge- 68Ga generator elution product were pH 4.5, reaction at 85 ℃ for 15 min, and the radiochemical purity of the product 68Ga-PSMA-11 was >95%. The imaging results of 68Ga-PSMA-11 labeled by domestic and imported generator elution products in 22Rv1 prostate cancer model mice showed high uptake of 68Ga-PSMA-11 at the tumor site, while the rest were mainly distributed in the kidneys and bladder. At 30, 60, and 90 min after injection, the radioactive uptake values of 68Ga-PSMA-11 labeled by the domestic 68Ge- 68Ga generator were lower than those of the imported 68Ge- 68Ga generator ((3.60±0.14) %ID/g vs. (5.30±0.42) %ID/g, (3.40±0.12) %ID/g vs. (5.90±0.36) %ID/g, (2.90±0.28) %ID/g vs. (5.50±0.33) %ID/g). The differences were statistically significant (LSD method, all P<0.05). Conclusion:No significant difference was observed in the distribution of 68Ga 3+ and its labeled 68Ga-PSMA-11 in normal mice and tumor model mice between the domestic 68Ge- 68Ga generator and the imported 68Ge- 68Ga generator.