动态显色法定量测定头孢曲松钠原料药中细菌内毒素含量  

Quantitative determination of bacterial endotoxin content in ceftriaxone sodium by dynamic chromogenic method

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：《中国处方药》2025年第7期41-44,共4页Journal of China Prescription Drug

摘　　要：目的建立头孢曲松钠原料药中的细菌内毒素的定量检测方法。方法按中国药典四部通则1143相关规定,采用动态显色法检测样品中的内毒素含量,考察头孢曲松钠溶液的干扰及内毒素回收比。结果头孢曲松钠稀释到0.0625 mg/ml时,动态显色法干扰试验符合规定,可排除干扰。结论采用动态显色法进行细菌内毒素检查均可行。Objective To establish a quantitative detection method of bacterial endotoxin in ceftriaxone sodium.Methods According to the relevant provisions of the general rule 1143 of Chinese Pharmacopoeia,the endotoxin in the samples was detected by dynamic color development method,and the interference of ceftriaxone sodium solution and the endotoxin recovery ratio were investigated.Results When ceftriaxone sodium was diluted to 0.0625 mg/ml,the interference test of dynamic chromogenic method met the requirements and the interference could be excluded.Conclusion Bacterial endotoxin test by dynamic chromogenic method is feasible.

关 键 词：头孢曲松钠 细菌内毒素 原料药 动态显色法 

分 类 号：R927.2[医药卫生—药学]