氧氟沙星葡萄糖注射液中细菌内毒素定量检查研究  

Application of the Turbidimetric—kinetic Method for the Measurement of Endotoxin in Ofloxacin and Glucose Injection

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作  者:朱友林[1] 邰顺章 

机构地区:[1]江苏省盐城市妇幼保健院,224001 [2]江苏省盐城市药品检验所

出  处:《黑龙江医药》2004年第5期340-341,共2页Heilongjiang Medicine journal

摘  要:目的:对氧氟沙星葡萄糖注射液进行细菌内毒素回收干扰试验,建立定量检测氧氟沙星葡萄糖注射液中污染内毒素试验方法。方法:采用中国药典2000年版附录检测细菌内毒素的动态浊度法。结果:氧氟沙星葡萄糖注射液用细菌内毒素定量检测无干扰因素影响,内毒素回收率在50%~200%范围内。结论:使用内毒素动态浊度法定量检测氧氟沙星葡萄糖注射液的污染内毒素是可行的,可用细菌内毒素定量检查法代替家兔热原检查法。Objective:Appplication of the turbidimetric — kinetic method for practical quality control on endotoxin content in Ofloxacin and glucose injection.Methods:According to the tur- bidimetric — kinetic method and eliminated interfere factors approved by Chinese pharmacopoeia 2000 edition.Results and Conclusions:Endotoxin added to Ofloxacin and glucose injection was re- covered in a quntitative manner showing neither inhibition nor enhancement,the endotoxin recov- ery is more than 50 per cent and less than 200 per cent.These results suggest that the LAL—test could be used as an alternative method for the rabbit pyrogen test to Ofloxacin and glucose injec- tion.

关 键 词:氧氟沙星葡萄糖注射液 细菌内毒素 定量检查 动态浊度法 干扰试验 

分 类 号:R927.1[医药卫生—药学]

 

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