磺胺二甲嘧啶钠注射液和磺胺间甲氧嘧啶钠注射液细菌内毒素检查方法的改进研究

Study on Improvement of Bacterial Endotoxin Test for Sulfadimidine Sodium Injection and Sulfamonomethoxine Sodium Injection

关键词:  磺胺二甲嘧啶钠注射液  磺胺间甲氧嘧啶呐注射液  细菌内毒素  改进

Key words:  Sulfadimidine sodium injection  Sulfamonomethoxine sodium injection  Bacterial endotoxin test  Improvement

摘要:

对磺胺二甲嘧啶钠注射液和磺胺间甲氧嘧啶呐注射液的细菌内毒素检查方法的拟定标准进行了改进,通过固定浓度的盐酸溶液溶解供试品,再使用无热原滤膜过滤的方法排除了干扰。通过上述供试品前处理方法的改进,检验人员无需采用特殊灵敏度的鲎试剂,亦可完全消除干扰作用,增强了标准的可执行性。

Abstract:

The proposed standard for bacterial endotoxin test of sulfadimidine sodium injection and sulfamonomethoxine sodium injection was improved. The interference was eliminated by dissolving the test sample with hydrochloric acid solution of fixed concentration, and then filtering with pyrogen free filter membrane. With the improvement of the pre-treatment method of the test sample, the inspector does not need to use TAL reagent with special sensitivity, and can also completely eliminate the interference, which enhances the enforceability of the standard.