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目的建立人凝血因子Ⅷ、人凝血因子Ⅸ、人凝血酶、人抗凝血酶Ⅲ蛋白含量Lowry快速检测法,并进行验证。方法采用《中国药典》三部(2010版)Lowry法检测因子类产品的蛋白含量,通过耐用性研究降低辅料对方法的干扰,优化Lowry检测方法,并对方法的专属性、线性及范围、准确度、精密度进行验证。结果不同辅料对Lowry法的干扰程度不同,人凝血因子Ⅷ、人凝血因子Ⅸ、人凝血酶、人抗凝血酶Ⅲ样品分别稀释20、10、80、160倍,可明显降低辅料的影响;Lowry法与凯氏定氮法相关性良好,方法线性R>0.99,其准确度、精密度均良好。结论 Lowry法测定人凝血因子Ⅷ、人凝血因子Ⅸ、人凝血酶、人抗凝血酶Ⅲ蛋白含量操作简便、快速、准确,可用于产品的质量控制。
Objective To establish a Lowry rapid detection method of human coagulation factor Ⅷ, human coagulation factor Ⅸ, human thrombin and human antithrombin Ⅲ, and to validate it. Methods Lowry method was used to detect the protein content of factor products by using the Chinese Pharmacopoeia (2010) Lowry method, and the interference of adjuvant to the method was reduced by durability study. The Lowry detection method was optimized. The specificity, linearity and range of the method were accurate Degree, precision to verify. Results The interference degree of different adjuvants to Lowry method was different. The samples of human coagulation factor Ⅷ, human coagulation factor Ⅸ, human thrombin and human antithrombin Ⅲ were diluted by 20, 10, 80 and 160 times respectively, which could obviously reduce the influence of adjuvant. Lowry method and Kjeldahl method correlation is good, the method of linear R> 0.99, its accuracy and precision are good. Conclusion Lowry method for the determination of human coagulation factor Ⅷ, human coagulation factor Ⅸ, human thrombin, human antithrombin Ⅲ protein content simple, rapid and accurate, and can be used for product quality control.