锝[99mTc]亚甲基二膦酸盐注射液细菌内毒素定量检测

The Quantitative Determination of Bacterial Endotoxin in Technetium[99mTc-MDP]Methylenediphosphate Injection

为使用FC/ET型酶标分析仪对锝[^(99m)Tc]亚甲基二膦酸盐注射液(^(99m)Tc-MDP)的细菌内毒素含量进行定量检测,建立^(99m)Tc-MDP的光度动态显色方法,本研究对不同衰变时间细菌内毒素检测结果的影响进行分析,对不同浓度的^(99m)Tc-MDP供试品溶液进行细菌内毒素与鲎试剂之间光度反应的干扰实验。结果显示,供试品溶液稀释30倍后对光度法反应无干扰,细菌内毒素含量<0.600 EU/mL,符合2020版《中国药典》规定内毒素的含量<15 EU/mL;不同活度的^(99m)Tc-MDP与衰变后溶液的细菌内毒素检测结果无变化。建立的^(99m)Tc-MDP细菌内毒素定量检测法操作简单、重复性好、方法可靠,可用于^(99m)Tc-MDP注射液的细菌内毒素定量检查。

To study the influence of decay time on the results of bacterial endotoxin test,the content of bacterial endotoxins in technetium[^(99m)Tc]methylenebisphosphonate injection(^(99m)Tc-MDP)was quantitatively determined by FC/ET and the photometric dynamic coloration method toward ^(99m)Tc-MDP was established.The photometric interference assay between bacterial endotoxins and Tachypleus Amebocyte lysate(Tal)on ^(99m)Tc-MDP solutions of different concentrations was carried out,and the results showed that no interference was happened to spectrophotometry when the sample solution was diluted by 30 times,and the concentration of bacterial endotoxin was less than 0.600 EU/mL that was in accordance with the criteria of Chinese Pharmacopoeia(2020 version),which stipulates the concentration of endotoxin should be less than 15 EU/mL.Moreover,the bacterial endotoxin detection results of ^(99m)Tc-MDP with different activities were not changed after decay.This established ^(99m)Tc-MDP bacterial endotoxins quantitative detection method,which is easily operated,has good reproducibility and reliability that can be utilized for the quantitative assay of bacterial endotoxin of ^(99m)Tc-MDP injection.