凯氏定氮法测定医用重组胶原蛋白修复敷料中蛋白质

Determination of protein content in medical recombinant collagen repair dressing by Kjeldahl method

建立了测定医用重组胶原蛋白修复敷料中胶原蛋白含量的凯氏定氮法。参照《中华人民共和国药典》2020年版通则0731蛋白质含量测定方法第一法,将钨酸沉淀法进行了改良,对样品进行处理得到非蛋白氮样品溶液,用全自动凯氏定氮仪测定样品与非蛋白氮样品中的氮含量,并计算样品中的胶原蛋白含量。样品中非蛋白氮的平均质量分数为0.0100%,相对标准偏差为1.60%(n=6);胶原蛋白的平均质量分数为0.0999%,相对标准偏差为2.13%(n=6),样品加标平均回收率为98.82%。该方法可以有效消除样品中非蛋白氮的干扰,准确测定医用重组胶原蛋白修复敷料的胶原蛋白含量。

A Kjeldahl method was established to determine the content of collagen in collagen dressings.Referring to the first method of protein content determination in Chinese Pharmacopoeia(2020)General Principle 0731,the tungstic acid precipitation method was improved.The non protein nitrogen was obtained by treating the sample with the improved tungstic acid precipitation method.Nitrogen content of the sample and non-protein nitrogen solution were measured by using the fully automatic Kjeldahl nitrogen analyzer,and the collagen content in the sample was calculated.The average content of non protein nitrogen in the samples treated with tungstic acid precipitation method was 0.0100%,and the relative standard deviation was 1.60%(n=6).The average content of collagen was 0.0999%,the relative standard deviation value was 2.13%(n=6),and the average recovery rate was 98.82%.This method can effectively eliminate the interference of non protein nitrogen in the sample,and has good repeatability,which can accurately determine the collagen content of collagen dressings.