摘要
目的:建立甘露聚糖肽口服溶液中蛋白质含量的测定方法。方法:采用福林酚法测定甘露聚糖肽口服溶液中的蛋白质含量,对41批国家药品评价抽验样品进行了蛋白质含量的测定。结果:本法蛋白质检出限为0.2μg,蛋白质浓度在0~112μg范围内线性良好,r>0.999,平均回收率为105.2%,RSD=1.9%(n=9),41批样品蛋白质含量范围为37~68μg·mL^(-1)。结论:该方法灵敏、准确,可以更有效地控制甘露聚糖肽口服液的质量。
Objective： To establish a method of determining protein in mannatide oral solution. Methods： The Folin-Ciocalteu method was used to determine the protein, and 41 national evaluation samples were assayed. Results： The LOD was 0. 2 μg, the linearity relation- ship in the range of 0 - 112μg protein was good （r 〉 0. 999）, the average recovery was 105.1% with RSD of 1.9% （n = 9）, the content of protein of 41 national evaluation samples ware in range of 37 - 68 μg. Conclusion： The method was sensitive and accurate which can be used to control the quality of mannatide oral solution efficiently.
出处
《中国药物评价》
2017年第2期92-94,共3页
Chinese Journal of Drug Evaluation
