安琪酵母浸出物FM 902中内毒素含量检测方法的建立  

Development of a method for determination of endotoxin content in extract FM902 from Angel yeast

作　　者：颜为红 邹坤[1] 贺海波[1] 李啸[2] 伍业旭[2] 刘光耀[3] 陈置丰 汪鋆植[1] 邓张双[1] YAN Wel-hong;ZOU Kun;HE Hai-bo;LI Xiao;WU Ye-xu;LIU Guang-yao;CHEN Zhi-feng;WANG Jun-zhi;DENG Zhang-shuang(Hubei Key Laboratory of Natural Products Research and Development, College of Chemistry and Life Science, China Three Gorges University, Yichang 443002, Hubei Province, Chin)

机构地区：[1]三峡大学天然产物研究与利用湖北省重点实验室,湖北宜昌443002 [2]安琪酵母股份有限公司,湖北宜昌443003 [3]三峡大学医学院,湖北宜昌443002

出　　处：《中国生物制品学杂志》2018年第4期421-424,430,共5页Chinese Journal of Biologicals

基　　金：安琪酵母股份有限公司科研专项(SDHZ2013020)

摘　　要：目的建立安琪酵母浸出物FM902中内毒素含量检测方法。方法采用干热程序有效性试验、灵敏度复核试验、FM902凝胶法干扰试验和FM902凝胶半定量试验检测FM902中的内毒素含量。结果 FM902浸出物中所含内毒素为5 EU/mg,符合《中国药典》三部(2015版)的限量标准。结论成功建立了酵母浸出物FM902中内毒素含量检测方法,该方法操作简便,重复性好,可作为酵母浸出物中内毒素含量的评估方法。Objective To develop a method for determination of endotoxin content in extract FM902 from Angel yeast.Methods The endotoxin content of yeast extract FM902 was determined by effectiveness test,sensitivity test,FM902 gel interference test and FM902 gel semi-quantitative test.Results The endotoxin content in extract FM902 was 5 EU/mg,which met the limit standard in Chinese Pharmacopoeia（Volumn Ⅲ,2015 edition）.Conclusion A method for determination of endotoxin content in extract FM902 from Angel yeast was successfully developed,which was easy to handle and of good repeatability,and might be used for evaluation of endotoxin content in Angel yeast extract.

关 键 词：酵母浸出物FM902 内毒素 鲎试剂 

分 类 号：R392-33[医药卫生—免疫学]