油酸中细菌内毒素的定量测定  

Quantitation of the Bacterial Endotoxin in Oleic Acid

作　　者：万丽卿[1] 谷舒怡[1] 唐黎明[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2016年第5期611-614,共4页Chinese Journal of Pharmaceuticals

摘　　要：采用同体系法,建立了油酸中细菌内毒素(1)的定量检测方法。分别以1检查用水、0.05 mg/ml和0.1 mg/ml油酸为溶剂,配制1标准品溶液,验证动态浊度法标准曲线的可靠性。结果各反应体系标准曲线的相关系数r均大于0.98,阴性对照溶液中1的含量均小于标准曲线中的最低浓度。在上述各体系下,分别计算油酸中1的回收率。结果以1检查用水为溶剂,所得标准曲线对油酸中1的定量测定产生干扰;而以油酸为溶剂绘制标准曲线,对相同体系油酸中1的定量测定没有干扰,且方法重现性较好。以本研究建立的方法测定3批油酸样品,结果均符合规定。The homologous system method was applied for the establishment of a quantification method for the bacterial endotoxin （1） in oleic acid. The standard solutions of 1 were prepared with water （for the test of 1） and different concentrations of oleic acid （0.05 and 0.1 mg/ml） as the solvents for the reliability validation of the standard curves in the kinetic-turibidimetric assay. The results showed that the correlation coefficients for the standard curves in different systems were all greater than 0.98. The concentrations of the negative controls were lower than the lowest value in the corresponding standard curves. The recoveries in oleic acid were calculated respectively in the above systems. As a result, it would interfere the quantification of 1 in oleic acid when water （for the test of 1） was used as the solvent to prepare the standard solutions. However, it had no disturbance when oleic acid was used as the solvent, and the method reproducibility was good. The quantification results for three batches of samples determined by this method complied with the requirements.

关 键 词：油酸 细菌内毒素 动态浊度法 定量测定 

分 类 号：R927.2[医药卫生—药学]