斑蝥酸钠注射液中蛋白质的含量测定  

Determination of Residual Proteins in Sodium Disodium Cantharidinate Injection

作　　者：田甜[1] 祝晶[1] 曹桂红[1] 徐波 王璐 Tian Tian;Zhu Jing;Cao Guihong;Xu Bo;Wang Lu(Guizhou Institute for Food and Drug Control,Guiyang 550081,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550081

出　　处：《山东化工》2024年第17期193-195,共3页Shandong Chemical Industry

基　　金：2015年国家评价性抽验项目。

摘　　要：目的:建立2,2′-联喹啉-4,4′-二羧酸(BCA)测定斑蝥酸钠注射液中残留蛋白质含量的方法。方法:依据蛋白质分子在碱性溶液中将Cu^(2+)还原为Cu^(+),2,2′-联喹啉-4,4′-二羧酸(BCA)与Cu^(+)结合形成紫色复合物,在一定范围内其颜色深浅与蛋白质浓度呈正比,以蛋白质对照品溶液作标准曲线,采用紫外-分光光度法测定供试品中蛋白质含量。结果:蛋白质在20~100μg范围内,线性关系良好(R=0.9979),精密度RSD为1.6%,稳定性RSD为3.2%,重现性RSD为3.2%,平均回收率为93%,RSD为1.3%(n=9)。结论:此方法专属性强、精密度稳定性良好、准确度较高,可用作斑蝥酸钠中蛋白质的含量测定方法,确保用药安全及关注厂家的工艺是否合理并建立斑蝥酸钠中蛋白质残留的检测标准,以便更科学地进行斑蝥酸钠的质量控制。Objective:To establish a method for the determination of residual proteins in sodium disodium cantharidinate injection by 2,2,-biquinoline-4,4,-dicarboxylic acid(BCA).Methods:Based on the fact that protein molecules reduce Cu^(2+)to Cu^(+)in alkaline solution,and that 2,2′-biquinoline-4,4′-dicarboxylic acid(BCA)combines with Cu^(+)to form a violet color complex,and that the color depth of BCA is directly proportional to the concentration of proteins in certain range,the results were determined by UV-spectrophotometry with protein control solution as standard curve.The protein content in the test material was determined by UV-spectrophotometry using the protein control solution as the standard curve.The results showed good linearity(R=0.9979)in the range of 20~100μg for protein,with a precision RSD of 1.6%,a stability RSD of 3.2%,a reproducibility RSD of 3.2%,and an average recovery of 93%with an RSD of 1.3%(n=9).Conclusion:This method has strong specificity,good precision and stability,high accuracy,and can be used as a method for the determination of protein content in sodium disodium cantharidinate,to ensure the safety of medication and to pay attention to whether the manufacturer's process is reasonable and to establish a standard for the detection of protein residues in sodium disodium cantharidinate in order to carry out the quality control of sodium disodium cantharidinate in a more scientific way.

关 键 词：斑蝥酸钠注射液 蛋白质 含量测定 BCA 

分 类 号：O657.32[理学—分析化学]