不同稀释液对苯磺顺阿曲库铵注射液内毒素测定的影响研究  

Influence of different diluents on the determination of endotoxin in benzene sulfocisonatracurium injection

作　　者：李雪梅 肖斯婷 曹春然 Li Xuemei;Xiao Siting;Cao Chunran(Beijing Institute for drug control,Key Laboratory for safety research and evaluation of innovative drugs,State Drug Administration,Beijing Key Laboratory for analysis and biological evaluation of traditional Chinese medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《首都食品与医药》2024年第2期132-135,共4页Capital Food Medicine

摘　　要：目的检测苯磺顺阿曲库铵注射液的细菌内毒素含量。方法选用光度测定法中的动态显色法测定苯磺顺阿曲库铵注射液中内毒素的含量。结果采用动态显色法对苯磺顺阿曲库铵注射液进行内毒素含量检测,其稀释剂仅可采用镁离子缓冲液,采用细菌内毒素检查用水进行实验时,实验方法不成立。结论苯磺顺阿曲库铵对鲎试剂与内毒素的凝集反应有较强的抑制作用,采用镁离子缓冲液作为稀释剂对其内毒素进行测定,方法可靠、结果准确。Objective To detect the content of bacterial endotoxin in cisatracurium benzoate injection.Methods Dynamic chromogenic spectrophotometry was used to determine the content of endotoxin in cisatracurium benzenesulfonate injection.Results The endotoxin content of cisatracurium benzenesulfonate injection was detected by dynamic chromogenic method,and only magnesium ion buffer could be used as diluent.When sterilized water for injection was used,the test was not established.Conclusion Cisatracurium benzenesulfum has a strong inhibitory effect on the agglutination reaction between limulus amebocyte lysate and endotoxin.The method of using magnesium ion buffer as diluent for the determination of endotoxin is reliable and accurate.

关 键 词：苯磺顺阿曲库铵注射液 细菌内毒素 动态显色法 含量检测 镁离子缓冲液 

分 类 号：R927.2[医药卫生—药学]