人纤维蛋白原制剂中蛋白质含量测定方法的探究

Research on the determination method of protein content in human fibrinogen preparation

目的:探究适宜的人纤维蛋白原制剂中蛋白质含量测定方法。方法:分别应用《中国药典》三部(2010年版)中蛋白质测定法项下三氯醋酸沉淀法和两种改良后的三氯醋酸法测定6批人纤维蛋白原制剂中的蛋白质含量,比较三种方法的稳定性和平行性。结果:改良后的三氯醋酸沉淀2法[用三氯醋酸代替《中国药典》三部(2010年版)钨酸钠沉淀法中钨酸钠和硫酸溶液]的稳定性和平行性明显比《中国药典》三部(2010年版)中蛋白质测定法项下三氯醋酸沉淀法和改良后的三氯醋酸沉淀3法更好,相对标准偏差(RSD)更低。结论:改良后的三氯醋酸沉淀2法更适合人纤维蛋白原制剂中蛋白质含量的测定。

Objective： To explore the suitable determination method of protein content in people fibrinogen preparation.Methods： The trichloroacetic acid precipitation method in the ＂ Chinese pharmacopoeia＂ three（ 2010 edition） and two kinds of modified trichloroacetic acid method are used to measure the protein content of six group fibrinogen preparation,the stability and parallel of the three methods are compared. Results： The Stability and parallel of the modified trichloroacetic acid precipitation method 2（ Trichloroacetic acid instead of sodium tungstate and sulfuric acid solution in the sodium tungstate precipitation method） are better than trichloroacetic acid precipitation method and modified trichloroacetic acid precipitation method 3,relative standard deviation values（ RSD） value is lower. Conclusion： The modified trichloroacetic acid precipitation method 2 is more suitable to measure the protein content in human fibrinogen preparation.