中国药房2012,Vol.23Issue(9):844-845,2.DOI:10.6039/j.issn.1001-0408.2012.09.27
注射用夫西地酸钠细菌内毒素检查方法研究
Study on Bacterial Endotoxin Test of Sodium Fusidate for Injection
徐冬 1除玲笑2
作者信息
- 1. 浙江衢化医院,浙江衢州324004
- 2. 衢州市食品药品检验所,浙江衢州324002
- 折叠
摘要
Abstract
OBJECTIVE: To establish a method for bacterial endotoxin test of Sodium fusidate for injection. METHODS: Maximum concentration without interference of samples was determined by interference test according to gel-clot stated in appendix of Chinese Pharmacopoeia (2010 edition). And then methodology validation was conducted. RESULTS: The interference on bacterial endotoxin test can be excluded when sample was diluted to below 0.50 mg·mL-1. CONCLUSION: The established method is feasible to detect the bacterial endotoxin of Sodium fusidate for injection.关键词
注射用夫西地酸钠/细菌内毒素检查/凝胶法/干扰试验Key words
Sodium fusidate for injection/ Bacterial endotoxin test/ Gel-clot/ Interference test分类
医药卫生引用本文复制引用
徐冬,除玲笑..注射用夫西地酸钠细菌内毒素检查方法研究[J].中国药房,2012,23(9):844-845,2.