离子选择性凯氏定氮法测定注射用乳糖中残留蛋白含量  

Ion-selective Kjeldahl method used in the detection of residue protein in lactose for intravenous injection

作　　者：杨锐[1] 韩旭 袁松[1] 于丽娜[1] 孙会敏[1] 李波[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京托毕西制药有限公司,北京100036

出　　处：《药物分析杂志》2012年第5期843-845,860,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：化学新药质量标准研究与评价技术平台;课题编号2011ZX09303

摘　　要：目的:建立高灵敏度的检测乳糖中痕量残留蛋白的含量。方法:采用离子选择性凯氏定氮法对乳糖中残留蛋白的含量进行测定。结果:离子选择性凯氏定氮法有较高的灵敏度(其最低检出限在0.06μg·mL-1,而传统的凯氏定氮法最低检出限大多在毫克水平),且在0.2～100μg·mL-1范围内氨气敏电极测定的毫伏数与蛋白质中的氮含量有较好的线性关系;高、中、低3个浓度水平的平均回收率分别为99.9%,99.3%,99.0%;精密度考察RSD为1.4%。结论:离子选择性凯氏定氮法检测限低,简便、快捷,适用于乳糖中痕量蛋白的测定。Objective： To determine the content of residue protein in lactose for intravenous.Methods： Ion-selective Kjeldahl method.Results： Ion-selective Kjeldahl method（the LOD was 0.06 μg·mL-1） was more sensitive than the normal lactose（the LOD was in mg level）,the standard curve was linear in the range from 0.2-100 μg·mL-1.The average recoveries of high,medium and low concentration were 99.9%,99.3%,and 99.0%,respectively.The RSD of precision test was 1.4%.Conclusion： Ion-selective Kjeldahl method is convenient,efficient,and is a good method used in the detection of residue protein in lactose for intravenous.

关 键 词：药用辅料 赋形剂 稀释剂 保护剂 注射剂 乳糖 杂质 残留蛋白 检测 含量测定 安全监测 

分 类 号：R917[医药卫生—药物分析学]