福林酚法测定甘露聚糖肽口服溶液中蛋白质的含量

福林酚法测定甘露聚糖肽口服溶液中蛋白质的含量

贺建华

大连市药品检验所

收稿日期:2016-09-02 修回日期:2016-09-02 出版日期:2017-04-25 发布日期:2017-04-25

Determination of Protein in Mannatide Oral Solution by Folin-Ciocalteu Method

Dalian Institute for Drug Control

Received:2016-09-02 Revised:2016-09-02 Online:2017-04-25 Published:2017-04-25

摘要/Abstract

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0.2 μg，蛋白质浓度在0～112 μg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37～68 μg?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。

Abstract: 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 relationship in the range of 0～112 μg 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.

贺建华. 福林酚法测定甘露聚糖肽口服溶液中蛋白质的含量[J]. .