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研制了一种药盒 ,能简单、快速、有效地制备188Re -硫化铼混悬液制剂。药盒由A、B、C 3瓶 (10mL/瓶 )组成 ,在无菌环境下 ,配制各种试剂。A瓶加入mol比为 70 :1的Na2 S2 O3 和KReO4溶液 1mL ,再加入一定量的赋形剂 ;B瓶加入 5mol/L的盐酸溶液 1mL ;C瓶加入摩尔比为 10 0 0 :1的PVP和NaOH溶液 1.5mL。B瓶加盖密封 ;A瓶和C瓶在冷冻干燥后 ,压盖密封。无菌、细菌内毒素及安全性检验均合格。常温下放置 ,制备188Re -硫化铼混悬液 ,在两个月内始终保持很高的标记率 (>98% ) ,颗粒度为 1— 5 μm(6 0 .1± 12 .7) % ;5— 10 μm(30 .9± 8.1) % ;>10 μm(9.0±4 .7) %。制备的188Re -硫化铼混悬液在 5天内非常稳定 ,放化纯度 >98% ,颗粒度为 1— 5 μm(49.9± 4 .4 ) % ;5— 10 μm(41.1± 5 .4 ) % ;>10 μm(9.0± 3.3) %。
A kit was developed to prepare 188Re-rhenium sulfide suspension formulations simply, rapidly and efficiently. Kit consists of A, B, C 3 bottles (10mL / bottle) composition, in a sterile environment, the preparation of a variety of reagents. A bottle was added to the mol ratio of 70: 1 Na2 S2 O3 and KReO4 solution 1mL, then add a certain amount of excipients; B bottle was added 5mol / L hydrochloric acid solution 1mL; C bottle was added molar ratio of 100: 1 PVP and NaOH solution 1.5mL. B bottle cap seal; A bottle and C bottle after freeze-drying, gland seal. Sterile, bacterial endotoxin and safety tests are qualified. At room temperature, the 188Re - rhenium sulfide suspension was prepared and maintained at a high labeling rate (> 98%) for 1 - 5 μm (60 ± 1. 5- 10 μm (30.9 ± 8.1)%;> 10 μm (9.0 ± 4.7%). The prepared 188Re-rhenium sulfide suspension was very stable within 5 days with a radiochemical purity of> 98% and a particle size of 1 to 5 μm (49.9 ± 4 .4)%; 5 to 10 μm (41.1 ± 5.4)%, ;> 10 μm (9.0 ± 3.3)%.