^(153)Sm-EDTMP注射液活度测量标准化研究

Study on the Standardization of the Radioactivity Measurement for ^(153)Sm-EDTMP Injection

治疗用放射性药品活度与其用药安全性和有效性直接相关。为了确保^(153)Sm-EDTMP注射液用药安全有效,本工作对使用活度计测量^(153)Sm-EDTMP注射液活度的方法进行了标准化研究。采用4家实验室的4πβ液闪、4πβ-γ符合测量系统共6套测量系统对^(153)Sm-EDTMP注射液标准源的活度进行了定值,其相对扩展不确定度<3%(包含因子k=3)。再利用已知活度的标准源,对使用活度计测量^(153)Sm-EDTMP注射液活度的方法进行了标准化研究。结果表明,不同活度计型号、容器和样品体积对测量结果均有影响,但样品溶液体积为3～5 mL时,溶液体积变化对测量结果的影响很小。本工作根据以上研究结果确定了测量条件。

The safety and efficacy of the therapeutic radiopharmaceuticals directly depends on its dosage. In order to determine the radioactivity of 153Sm-EDTMP injection accurately, and ensure the safety and efficacy of the 153Sm-EDTMP injection, the standardization for the radioactivity measurement of 153Sm-EDTMP injection with dose calibrators was studied, in which 4π liquid scintillator and 4πβ-γ coincidence method were used to determine the values of radioactivity（the relative expanded uncertainty is less than 3% for the 153 Sm-EDTMP injection standard source with six experimental setups in four laboratories, then the dose cali- brators were calibrated with the standard source. The results showed that a the type of dose calibrator, the container and the volume of the sample solution have effects on the results of measurement, but between 3 to 5 mL, the variation of the volume of sample solution has little effect on the results of measurement. At last the measurement conditions were obtained according to the results of the study.