盐酸艾司洛尔注射液细菌内毒素检查法的实验研究

中国药物警戒 ›› 2011, Vol. 8 ›› Issue (4): 197-198.

盐酸艾司洛尔注射液细菌内毒素检查法的实验研究

周修森

信阳市食品药品检验所,河南信阳 464000

收稿日期:2015-08-27 修回日期:2015-08-27 出版日期:2011-04-10 发布日期:2015-08-27
作者简介:周修森,男,副主任药师,药品检验。

The Experiment of Bacterial Endotoxin Test for Esmolol Hydrochloride Injection

ZHOU Xiu-sen

Xinyang Institute for Food and Drug Control, Henan Xinyang 464000, China

Received:2015-08-27 Revised:2015-08-27 Online:2011-04-10 Published:2015-08-27

摘要/Abstract

摘要： 目的建立盐酸艾司洛尔注射液的细菌内毒素检查法。方法按2010年版《中国药典》细菌内毒素检查法相关规定进行试验。结果本品最大不干扰浓度以盐酸艾司洛尔计为1.2mg·mL-1。结论所建立的盐酸艾司洛尔注射液的细菌内毒素检查方法具有可行性,其内毒素限值可定为0.20EU·mg-1。

关键词: 盐酸艾司洛尔, 细菌内毒素检查, 干扰试验

Abstract: Objective To establish the bacterial endotoxins determination method for esmolol hydrochloride injection． Methodse According to the method in the appendix of the Chinese Pharmacopoeia(edition 2010), the bacterial endotoxin test was carried out． Results The maximum non-disturb concentration of esmolol hydrochloride is 1.2mg·mL-1．Conclusion The method of bacterial endotoxin test is feasible with the limit of 0.20 EU·mg-1 for esmolol hydrochlo-ride injection．

中图分类号:

R927.12

周修森. 盐酸艾司洛尔注射液细菌内毒素检查法的实验研究[J]. 中国药物警戒, 2011, 8(4): 197-198.

ZHOU Xiu-sen. The Experiment of Bacterial Endotoxin Test for Esmolol Hydrochloride Injection[J]. Chinese Journal of Pharmacovigilance, 2011, 8(4): 197-198.