西咪替丁片中微晶纤维素的测定研究  

Study on the Determination of Microcrystalline Cellulose in Cimetidine Tablets

作　　者：梅雪娇 闫翔宇 卢定强[3] 严相平 Mei Xue-jiao;Yan Xiang-yu;Lu Ding-qiang;Yan Xiang-ping(School of Biological and Pharmaceutical Engineering,Nanjing Tech University,Nanjing 211816,Jiangsu Province,China;Department of Pharmacy,Jiangsu Pharmaceutical Research Institute Co,LTD,Nanjing 210009,Jiangsu Province,China;School of Pharmacy,Nanjing Tech University,Nanjing 211816,Jiangsu Province,China;Nanjing Polytechnic Institute,Nanjing 210044,Jiangsu Province,China)

机构地区：[1]南京工业大学生物与制药工程学院,江苏南京211816 [2]江苏省药物研究所有限公司药学部,江苏南京210009 [3]南京工业大学药学院,江苏南京211816 [4]南京科技职业学院,江苏南京210044

出　　处：《中外医药研究》2023年第3期3-5,共3页JOURNAL OF CHINESE AND FOREIGN MEDICINE AND PHARMACY RESEARCH

摘　　要：目的:建立一种测定制剂中微晶纤维素(MCC)的分析方法。方法:以纤维素酶将纤维素水解成还原糖,测定还原糖得到MCC的含量。结果:本实验所用纤维素酶的最适温度为50℃,最适pH值为4.8;方法学验证结果显示,MCC质量浓度在0.0445~0.0691 mg/mL间呈线性,R^(2)=0.9956;平均回收率为102.8%。结论:本法精确度高、专属性强,解决了在复杂体系中难以测定MCC的问题,在药物处方剖析方面有较大意义。Objective:To establish an analytical method for the determination of microcrystalline cellulose(MCC)in preparations.Methods:Cellulase was used to hydrolyze cellulose into reducing sugars,and the content of MCC was obtained by measuring the reducing sugars.Results:The optimum temperature of cellulase used in this experiment was 50℃and the optimum pH was 4.8.The results of methodological validation showed that the mass concentration of MCC was linear between 0.0445 and 0.0691 mg/mL with R^(2)=0.9956;the average recovery was 102.8%.Conclusion:The present method is highly accurate and specific,solving the problem of difficult determination of MCC in complex systems,and is of great significance in drug prescription profiling.

关 键 词：微晶纤维素 纤维素酶 二硝基水杨酸法 还原糖测定 

分 类 号：TS2[轻工技术与工程—食品科学与工程]