甲磺酸帕珠沙星氯化钠注射液细菌内毒素检查方法学确证  

Study on the bacterial endotoxin test in Pazufloxacin Mesylate and Sodium Chloride Injections

作　　者：韩纯洁 郑旭 罗晶 李晓春 王莉芳 陈芳 胡萌萌 

机构地区：[1]陕西省食品药品检验所,西安710061

出　　处：《西北药学杂志》2012年第5期464-466,共3页Northwest Pharmaceutical Journal

摘　　要：目的建立甲磺酸帕珠沙星氯化钠注射液细菌内毒素检查方法。方法按《中国药典》2010年版二部附录ⅪE细菌内毒素检查法中凝胶法干扰实验原则,分别用2个厂家鲎试剂对3批甲磺酸帕珠沙星氯化钠注射液进行凝胶法干扰实验和细菌内毒素检查。结果将甲磺酸帕珠沙星氯化钠注射液稀释8倍,可消除干扰作用。结论采用凝胶法对甲磺酸帕珠沙星氯化钠注射液进行细菌内毒素检查可行。Objective To establish a method for the detection of bacterial endotoxins in Pazufloxacin Mesylate and Sodium Chloride Injections. Methods According to the guideline and procedures specified in appendix ⅪE of volume two in Chinese Pharmacopoeia （2010 edition）, the gel-clot interference experiment and bacterial endotoxins test of 3 batches of Pazufloxacin Mesylate and Sodium Chloride Injections were carried out, using tachypleus amebocyte lysate from 2 different companies. Results It was proved that the interference was eliminated with samples diluted 8 folds. Conclusion The gel-clot test is suitable for detecting bacterial endotoxins in Pazufloxacin Mesylate and Sodium Chloride Injections.

关 键 词：甲磺酸帕珠沙星氯化钠注射液 细菌内毒素 鲎试剂 干扰实验 

分 类 号：R927[医药卫生—药学]