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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: To determine the amount of illegally added hydrogen peroxide in Tween 80 by indirect iodometric method using catalase. Methods: Hydrogen peroxide was used to decompose hydrogen peroxide in the sample. The content of strong oxide in the sample before and after decomposition was determined by indirect iodometric method, and the content of hydrogen peroxide in the sample was calculated. Results: Hydrogen peroxide was tested in 18 batches of Tween 80 in seven plants, with all samples containing hydrogen peroxide up to 185.3 μg · g -1. Conclusion: As a common pharmaceutical excipient for injection, the residual hydrogen peroxide in Tween 80 can seriously affect the safety of the injection. Using this method, the content of hydrogen peroxide can be detected easily and quickly.