Thokchom Arun Kumar, Kumar Rajesh, Bharati Sanjay
Department of Nuclear Medicine, Manipal College of Health Profession, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Department of Nuclear Medicine, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Indian J Nucl Med. 2022 Jan-Mar;37(1):7-11. doi: 10.4103/ijnm.ijnm_115_21. Epub 2022 Mar 25.
Tc-99m Methylene diphosphonate (MDP) is prepared in house by labeling MDP cold kit. Each kit is a single time use vial and contains large amounts of reagent sufficient for preparing multiple doses. Therefore, several centers are adopting the practice of fractionating the MDP kit so that it can be used multiple times. The aim of the study was to evaluate the effect of kit fractionation on radiopharmaceutical property.
The MDP kit was fractionated using two different approaches, namely, vial and syringe method. The quality of Tc-99m MDP prepared using these approaches was assessed and compared with that prepared by the conventional method. The image quality was evaluated in a total of 100 patients.
The vial and syringe fractionated Tc-99m MDP showed >95% RCP till the 4 and 2 days of fractionation, respectively. Percentage radiochemical purity deteriorated to 83.6% and 88% on the 8 day of fractionation in the vial and syringe method, respectively. No microbial growth was observed in any of these methods till the 8 day of fractionation. The reconstituted MDP solution during all preparations was clear and colorless in appearance with pH ranging from 6.5 to 7.5. The image contrast, contrast-to-noise, and signal-to-noise ratio were statistically similar in both methods compared to the conventional method until the 2 day of fractionation. The image quality data showed no statistical difference among images of vial and syringe fractionated MDP as compared to the conventional unfractionated Tc-99m MDP.
The observations revealed that if fractionated with utmost care, both methods yield almost similar results.
锝-99m亚甲基二膦酸盐（MDP）通过标记MDP冷试剂盒在内部制备。每个试剂盒是一次性使用的小瓶，含有大量足以制备多剂的试剂。因此，几个中心正在采用将MDP试剂盒分份以便能多次使用的做法。本研究的目的是评估试剂盒分份对放射性药物性质的影响。
采用两种不同方法对MDP试剂盒进行分份，即小瓶法和注射器法。评估使用这些方法制备的锝-99m MDP的质量，并与传统方法制备的进行比较。对总共100例患者的图像质量进行评估。
小瓶法和注射器法分份的锝-99m MDP分别在分份后的第4天和第2天显示放射性化学纯度>95%。在分份后的第8天，小瓶法和注射器法的放射性化学纯度百分比分别降至83.6%和88%。直到分份后的第8天，在任何这些方法中均未观察到微生物生长。在所有制剂中，重构的MDP溶液外观均清澈无色，pH值在6.5至7.5之间。与传统方法相比，在分份后的第2天之前，两种方法的图像对比度、对比噪声比和信噪比在统计学上相似。与传统未分份的锝-99m MDP相比，小瓶法和注射器法分份的MDP图像的图像质量数据显示无统计学差异。
观察结果表明，如果极其小心地进行分份，两种方法产生的结果几乎相似。
