过氧化氢酶间接碘量法测定吐温80中过氧化氢的含量  

Determination of hydrogen peroxide in polysorbate 80 by indirect catalatic iodimetry method

作　　者：杨锐[1] 孙会敏[1] 袁松[1] 于丽娜[1] 栾林[1] 王颖[1] 关皓月[1] 高志峰[1] 郭志鑫[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2012年第6期1040-1042,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:用过氧化氢酶间接碘量法测定吐温80中非法加入的过氧化氢的含量。方法:用过氧化氢酶分解样品中的过氧化氢,通过间接碘量法测定分解前后样品中强氧化物的含量,计算样品中过氧化氢的含量。结果:检测了7个厂家18批吐温80中过氧化氢的含量,所有样品全都检测出含有过氧化氢,最高达到了185.3μg·g-1。结论:作为注射剂常用的药用辅料,吐温80中残留的过氧化氢会对注射剂的安全造成严重影响,利用本法可以简便、快捷的检测出过氧化氢含量。Objective：Determine the hydrogen peroxide residue in polysorbate 80 by the Indirect Iodimetry Method using catalase.Method：The superoxide values in polysorbate 80 will decreased after decomposition of hydrogen peroxide catalyzed by catalase.The content of hydrogen peroxide would been calculated from the decreasing value.Results：18 batches polysorbate 80 from seven producers were analysed,the maximum hydrogen peroxide content was 185.3 μg·g-1.Conclusion：The hydrogen peroxide residue in polysorbate 80 is very dangerous for the injection,the method mentioned in this text is convenient and efficient to determine the hydrogen peroxide residue in polysorbate 80.

关 键 词：药用辅料 聚山梨醇酯(吐温)80 杂质残留 过氧化氢 间接碘量法 含量测定 

分 类 号：R917[医药卫生—药物分析学]