肿瘤药学Issue(4)：313-315,3.DOI:10.3969/j.issn.2095-1264.2013.077
注射用盐酸吉西他滨细菌内毒素检查方法研究
Detection of Bacterial Endotoxin in Gemcitabine Hydrochloride Injection
雷德卿 1李帅2
作者信息
- 1. 邵阳市食品药品检验所，湖南 邵阳，422000
- 2. 湖南省长沙市第三医院，湖南 长沙，41000
- 折叠
摘要
Abstract
Objective To establish a procedure to detect the bacterial endotoxin in Gemcitabine Hydrochloride injection. Methods Tachypleus Amebocyte Lysate test were optimized to detect the bacterial endotoxin referring to Chinese Pharmaco-poeia (Edition 2010). Results The sample did not interfere according to the proposed method test. The bacterial endotoxin de-tection results of three lots of Gemcitabine Hydrochloride injection were all within normal ranges. Conclusion The method for detecting bacterial endotoxin in Gemcitabine Hydrochloride injection is simple and feasible. It can be used in the quality control of Gemcitabine Hydrochloride injection.关键词
注射用盐酸吉西他滨/细菌内毒素/干扰试验Key words
Gemcitabine Hydrochloride injection/Bacterial endotoxin/Interference test分类
医药卫生引用本文复制引用
雷德卿,李帅..注射用盐酸吉西他滨细菌内毒素检查方法研究[J].肿瘤药学,2013,(4):313-315,3.
