氧氟沙星葡萄糖注射液细菌内毒素检查法  

The examination of bacterium endotoxin in Ofloxiacin injection

作　　者：张永波 刘力明 门秀茹 

机构地区：[1]牡丹江温春双鹤药业有限责任公司,157041

出　　处：《牡丹江医学院学报》2004年第2期20-23,共4页Journal of Mudanjiang Medical University

摘　　要：目的 :探讨氧氟沙星葡萄糖注射液细菌内毒素检查法。方法 :对三个不同批号的氧氟沙星葡萄糖注射液进行干扰试验。先对内毒素限值进行确定 ,在确定干扰试验的起始浓度及浓度范围 ,在有效范围内进行干扰试验。考察样品液、1倍稀释原液及 4倍稀释液条件下 ,样品对试验的干扰情况。结果 :氧氟沙星原液 (0 .0 8% )和 1倍稀释液 (0 .0 4 % )对试验均有干扰行为 ,而 4倍稀释液 (0 .0 2 % )对试验无干扰行为。结论 :该氧氟沙星葡萄糖注射液使用灵敏度为 0 .12 5Eu/mL的鲎试剂 ,将样品按 1:3稀释后 。Objective: Investigate the examination of bacterium endotoxin in Ofloxiacin injection. Methods: using interference test on Ofloxiacin injection which from three different pharmaceutical factory in order to determine the number range of Ofloxacin in Ofloxiacin injection. And determine the initial number and the number range of concentration of interference test , doing the test in the effective concentration . Observe the interference condition of sample at the condition of sample solution (0.08%), one multiple diluent(0.04%), four multiple diluent(0.02%). Results: Ofloxacin diluent and one multiple diluent can interference the experience , four multiple diluent cannot interference the test. Conclusions: It is probable to examine the bacterium endotoxin of Ofloxacin on four multiple diluent (0.08%) by using limulus test which sensitivity is 0.125 Eu/mL.

关 键 词：氧氟沙星葡萄糖注射液 细菌内毒素检查法 干扰试验 药物检验 

分 类 号：R927.1[医药卫生—药学]