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

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.