中国药房Issue(27)：3853-3854,2.DOI:10.6039/j.issn.1001-0408.2015.27.39
帕拉米韦氯化钠注射液细菌内毒素检查方法的建立
Establishment of Bacterial Endotoxin Test Method for Peramivir Hydrate and Sodium Chloride Injection
乔世琴 1孙著叶 1李维刚 1吴立磊2
作者信息
- 1. 日照市中医医院药剂科，山东日照 276800
- 2. 山东绿因药业有限公司，山东临沂 276000
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for bacteria1 endotoxin test for Peramivir hydrate and sodium chloride injec-tion. METHODS:Maximum non-interference concentration of the sample with different batohes were used for interference test. was determined by interference test according to endotoxin gel method stated in Chinese Pharmacopiea (2010 edition)and bacterial en-edotoxintest by tachypleus amebocyte lysate from 2 manufact urers. RESULTS:The interference on bacterial endotoxin test could be excluded when the sample was diluted to 2.5 mg/ml and the limit of bacterial endotoxins was 0.5 EU/ml. CONCLUSIONS:The established method can be used to detect the bacterial endotoxin of Peramivir hydrate and sodium chloride injection.关键词
帕拉米韦氯化钠注射液/细菌内毒素检查/凝胶法/干扰试验Key words
Peramivir hydrate and sodium chloride injection/Bacterial endotoxin test/Gel method/Interference test分类
医药卫生引用本文复制引用
乔世琴,孙著叶,李维刚,吴立磊..帕拉米韦氯化钠注射液细菌内毒素检查方法的建立[J].中国药房,2015,(27):3853-3854,2.
