托拉塞米原料药前处理及细菌内毒素检查方法研究  

Pretreatment of torasemide and bacterialendotoxin test methods research

作　　者：莫玉焕 黄宪 MO Yuhuan;HUANG Xian(Guangxi Institute for Drug Control,Nanning 530021,China)

机构地区：[1]广西壮族自治区药品检验研究院,南宁530021

出　　处：《中国药品标准》2024年第6期600-606,共7页Drug Standards of China

摘　　要：目的:建立托拉塞米原料药的细菌内毒素检查方法。方法:用二甲基亚砜(DMSO)溶解托拉塞米,再用细菌内毒素检查用水(BET水)稀释,按中国药典四部通则1143相关规定,分别采用凝胶法、动态浊度法、动态显色法检测样品中的内毒素,考察托拉塞米溶液的干扰及内毒素回收比。结果:样品用DMSO溶解后,再用BET水稀释,没有析出,凝胶法、动态显色法、动态浊度法干扰试验符合规定,可排除干扰。结论:托拉塞米原料药经DMSO溶解后,采用凝胶法、动态浊度法、动态显色法进行细菌内毒素检查均可行。Objective:To establish a bacterial endotoxin test method for torasemide.Methods:Torasemide was dissolved in dimethyl sulfoxide(DMSO),and then diluted with bacterial endotoxin test water(BET water).According to the bacterial endotoxin test method of general rule 1143 in the fourth part of the 2020 edition of the“Pharmacopoeia of the People′s Republic of China,”the endotoxin in the sample was detected by gel method,dynamic turbidity method and dynamic chromogenic method,respectively.The interference of torasemide solution and the recovery ratio of endotoxin were investigated.Results:After the sample was dissolved in DMSO and diluted with BET water,there was no precipitation.The interference test of gel method,dynamic chromogenic method and dynamic turbidity method met the requirements and could be excluded.Conclusion:After dissolution of torasemide by DMSO,it is feasible to use gel method,dynamic turbidimetric method and dynamic chromogenic method for bacterial endotoxin test.

关 键 词：托拉塞米 细菌内毒素 二甲基亚砜 凝胶法 动态显色法 动态浊度法 

分 类 号：R921.2[医药卫生—药学]