动态浊度法测定注射用高纯度尿促性素中细菌内毒素的含量  

Determination of Endotoxin in Highly Purified Menotrophin for Injection by Kinetic-Turbidimetric Assay

作　　者：刘肃[1] 周永标[1] 肖瑛[2,3] 潘卫松[1] 

机构地区：[1]广州市药品检验所,广东广州510610 [2]暨南大学药学院,广东广州510632 [3]暨南大学中药药效物质基础及创新药物研究所广东省高校重点实验室,广东广州510632

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)

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.

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 

分 类 号：R927.2[医药卫生—药学]