分子排阻色谱法检测胰岛素中的大分子蛋白质

中国药典规定,用柱色谱法对胰岛素中的大分子蛋白进行测定,但所检测出的含量只能是一个相对准确值,重现性较差,出现偏差时也无法判断.文章通过柱色谱法及分子排阻色谱法两种方法对胰岛素中的大分子蛋白质进行定量的测定比较,认为可以用分子排阻色谱法代替柱色谱法检测胰岛素中的大分子蛋白质,并提交国家药典委员会,建议使用.

Test the High Molecular Weight Proteins in Insulin with Exclusin Chromatography Method

The test method of higher molecular weight proteins is column chromatography in Chinese pharmacopoeia.We test the higher molecular weight proteins with two methods: column chromatography and molecule exclusion chromatography.We compared the two methods,the result is as following,the test time of column chromatography is long,the peaks of the spent regenerant are decentralization,the peak width at half-height is more wider,so if we count by the area of the peaks,the error is bigger.Otherwise,the test time of molecule exclusion chromatography is shorter,the the peaks of the spent regenerant are centralized,the peak width at half-height is narrow,the error of result counted by peaks area is much less.So we consider the conclusion that we could replace the column chromatography method with molecular exclusion chromatography.