摘要
目的建立注射用高纯度尿促性素中细菌内毒素定量的检查方法。方法采用动态浊度法考察注射用高纯度尿促性素对鲎试剂的干扰作用。结果注射用高纯度尿促性素进行10～80倍稀释即可以有效地消除其对鲎试剂的干扰。结论动态浊度法和凝胶法都可以用于检测注射用高纯度尿促性素中的细菌内毒素。
Objetive To establish a bacterial endotoxin test method for Highly Purified Menotrophin for Injection. Methods Based on the bacterial endotoxin test Kinetic-Turbidimetric Assay method stated in Chinese Pharmacopoeia 2005 edition（second part）,the interference effect of the Highly Purified Menotrophin for Injection to TAL was studied. Results After 10 to 80 times dilution,it showed no interfere with the bacterial endotoxin test. Conclusion It is feasible for bacterial endotoxin test of Highly Purified Menotrophin for Injection be conducted both by Kinetic-Turbidimetric Assay and gel clot assay.
出处
《中国医药科学》
2011年第7期44-45,共2页
China Medicine And Pharmacy
基金
广东省广州市食品药品监督管理局科技计划项目(2010GZFDA006)
2010年建设中医药强省立项资助课题(2010124)
关键词
动态浊度法
注射用高纯度尿促性素
细菌内毒素
干扰试验
Kinetic-turbidimetric assay
Highly purified menotrophin for injection
Bacterial endotoxin
Interference test
