摘要
目的:建立帕拉米韦氯化钠注射液细菌内毒素的检查方法。方法:按2010年版《中国药典》(二部)附录细菌内毒素凝胶检查法,采用不同厂家的鲎试剂,通过干扰试验对不同批号的样品最大不干扰质量浓度及细菌内毒素进行检查。结果:样品质量浓度为2.5 mg/ml时对鲎试剂与细菌内毒素的凝集反应无干扰;样品的细菌内毒素限值为0.5 EU/ml。结论:本方法可用于帕拉米韦氯化钠注射液的细菌内毒素检查。
OBJECTIVE： To establish a method for bacterial 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 lysatc from 2 manufact ttrers. 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.
出处
《中国药房》
CAS
北大核心
2015年第27期3853-3854,共2页
China Pharmacy
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
Peramivir hydrate and sodium chloride injection
Bacterial endotoxin test
Gel method
Interference test
