人胰岛素注射液中锌含量测定的两种方法比较

Comparison of two methods for determining zinc in human insulin injection

目的:建立用酸解法测定人胰岛素注射液中锌含量的方法。方法:将供试品与盐酸混合蒸干后,使与蛋白络合的锌转化成氯化锌,再与锌试剂反应、比色。结果:平均加样回收率为97.47%,RSD为0.39%。本法与法定的测定结果基本一致。结论:本法简便、重现性好,可用于控制人胰岛素注射液中锌的质量。

Object： To establish an acid hydrolysis method for the determination of zinc in human insulin injection. Methods： After the injection being hydrolyzed, the resultant reacted with zinc reagent. Then the absorption spectrum of the reacting solution was determined. Results： The average recovery and the relative standard deviation was 97.47% and 0.39%, respectively. The results of zinc contents obtained by the two methods （acid hydrolysis and enzyme hydrolysis） were similar. Conclusion： The method was simple with good reproducibility and can be used for the quality control of zinc in human insulin injection.