Hegseth Karissa M, Warren Amy M, Hung Joseph C, Mosman Elton A
Division of Nuclear Medicine, Mayo Clinic, Rochester, Minnesota 55905-0001, USA.
J Nucl Med Technol. 2012 Sep;40(3):194-7. doi: 10.2967/jnmt.111.097584. Epub 2012 Jun 7.
It is a common practice to administer dyes and radiopharmaceuticals separately for the localization of sentinel nodes in patients with biliary tract malignancies. The objective of this study was to evaluate the chemical properties and particle size of filtered (99m)Tc-sulfur colloid before and after it is combined with indocyanine green for injection. This study also evaluated the compatibility and stability of the two when combined, for the possibility of a single injection.
(99m)Tc-sulfur colloid was prepared according to the package insert, and the final preparation was passed through a sterile 0.2-μm filter. Green dye was also prepared as per the package insert. In a sterile syringe, 0.25 mL of 14.8-MBq (400-μCi) filtered (99m)Tc-sulfur colloid was mixed with 0.25 mL of 1.25-mg green dye in a 1:1 proportion for a total volume of 0.50 mL. The radiochemical purity and pH of filtered (99m)Tc-sulfur colloid were obtained immediately and at 1 and 2 h after preparation. Particle size was analyzed using an electron microscope immediately and at 2 h.
The average radiochemical purity was 97.6% ± 2.0% (n = 51). The average pH was 5.56 ± 0.26 (n = 51). Evaluation of the particle size of filtered (99m)Tc-sulfur colloid with the green dye was determined by electron microscopy to be an average of 53 ± 30 nm (n = 365) at 0 h and 60 ± 35 nm (n = 303) at 2 h. This was compared with filtered (99m)Tc-sulfur colloid without the green dye, which averaged 71 ± 41 nm (n = 41). Measurements of unfiltered (99m)Tc-sulfur colloid were recorded at 253 ± 192 nm (n = 21) for additional comparisons.
The chemical properties and particle size of filtered (99m)Tc-sulfur colloid were not affected by the addition of the green dye; thus, combination of filtered (99m)Tc-sulfur colloid and green dye in the same syringe for administration is suitable.
在胆道恶性肿瘤患者中，分别注射染料和放射性药物以定位前哨淋巴结是一种常见做法。本研究的目的是评估过滤后的（99m）锝硫胶体在与吲哚菁绿混合注射前后的化学性质和粒径。本研究还评估了两者混合时的相容性和稳定性，以确定是否有可能单次注射。
根据产品说明书制备（99m）锝硫胶体，最终制剂通过无菌0.2μm过滤器。绿色染料也按产品说明书制备。在无菌注射器中，将0.25 mL 14.8 MBq（400μCi）过滤后的（99m）锝硫胶体与0.25 mL 1.25 mg绿色染料按1:1比例混合，总体积为0.50 mL。在制备后立即以及1小时和2小时时获得过滤后的（99m）锝硫胶体的放射化学纯度和pH值。使用电子显微镜在立即和2小时时分析粒径。
平均放射化学纯度为97.6%±2.0%（n = 51）。平均pH值为5.56±0.26（n = 51）。通过电子显微镜评估，过滤后的（99m）锝硫胶体与绿色染料混合后的粒径在0小时时平均为53±30 nm（n = 365），在2小时时为60±35 nm（n = 303）。将其与未添加绿色染料的过滤后的（99m）锝硫胶体进行比较，后者平均为71±41 nm（n = 41）。还记录了未过滤的（99m）锝硫胶体的粒径为253±192 nm（n = 21）以作额外比较。
过滤后的（99m）锝硫胶体的化学性质和粒径不受添加绿色染料的影响；因此，将过滤后的（99m）锝硫胶体和绿色染料在同一注射器中混合给药是合适的。
