哌拉西林钠及其注射剂的细菌内毒素检查研究  

Study on Testing The Bacterial Endotoxins of Piperacillin Sodium and Piperacillin Sodium for Injection

作　　者：牛慧玲[1] 马辉[1] 陈志英[1] 

机构地区：[1]黑龙江省药品检验所,150001

出　　处：《中国药品标准》2006年第1期60-64,共5页Drug Standards of China

摘　　要：目的：建立哌拉西林钠及注射用哌拉西林钠的细菌内毒素检验方法。方法：依据《中国药典》2000年版附录细菌内毒素检查法进行试验。结果：哌拉西林钠及注射用哌拉西林钠在浓度不大于10mg/ml时对TAL试剂检测无干扰因素的影响。结论：该药采用细菌内毒素检查方法可行,可考虑代替热原检查。Objective：To establish a method for testing bacterial endotoxins of Piperacillin Sodium and Piperacillin Sodium for Injection. Methods： According to the Bacterial Endotoxins Test approved by Chinese Pharmacopoeia 2000 edition. Result： Piperacillin Sodium and its Injection did not interfere with bacterial endotoxins test when its concentration is not more than 10mg·ml^-1 Conclusion：It is suitable for bacterial endotoxin test of Piperaillin Sodium and Piperacillin Sodium for Injection. And it may take place of test for pyrogens.

关 键 词：哌拉西林钠 注射用哌拉西林钠 细菌内毒素检查法 干扰试验 

分 类 号：R978.1[医药卫生—药品] R927.12[医药卫生—药学]