硫辛酸原料药细菌内毒素检查法研究  

Establishment of Thioctic Acid Bacterial Endotoxin Test

作　　者：王欣[1] 张广伟[1] 张军霞[1] WAGN Xin;ZHANG Guang-wei;ZHANG Jun-xia(Henan Provincial Institute for Food and Drug Control,Zhengzhou 450018,China)

机构地区：[1]河南省食品药品检验所,河南郑州450018

出　　处：《河南医学研究》2020年第8期1369-1372,共4页Henan Medical Research

摘　　要：目的建立硫辛酸原料药细菌内毒素的检查项。方法依据《中国药典》2015版四部通则1143细菌内毒素检查法,对三批硫辛酸原料药进行了干扰试验和细菌内毒素检查。结果浓度1.25 mg·mL^-1的硫辛酸溶液对内毒素和鲎试剂的反应不存在干扰作用,确定内毒素限值为0.1 EU·mg^-1。结论细菌内毒素检查法可对硫辛酸原料药进行质量控制。Objective To establish a method for bacterial endotoxin of thioctic acid.Methods According to ChP. 2015 edition Vol Ⅳ1143,the interference test and bacterial endotoxin test of different batches of samples were carried out.Results Thioctic acid solution was diluted to 1.25 mg·mL^-1, the bacterial endotoxin test was not interfered. The limitation value of bacterial endotoxin was set as 0.1 EU·mg^-1.Conclusion The bacterial endotoxin test can be used for the quality control of thioctic acid.

关 键 词：硫辛酸 原料药 细菌内毒素检查法 干扰试验 

分 类 号：R921.2[医药卫生—药学]