氨茶碱片含量测定的不确定度分析  

Uncertainty Analysis of Content Determination of A minophylline Tablets

作　　者：朱清丽 肖娟 柯红梅 孙全明 ZHU Qing-li;XIAO Juan;KE Hong-mei;SUN Quan-ming(Ankang food and drug inspection and Testing Center,Ankang 725000,China)

机构地区：[1]安康市食品药品检验检测中心,陕西安康725000

出　　处：《海峡药学》2020年第11期71-75,共5页Strait Pharmaceutical Journal

摘　　要：目的通过对氨茶碱片含量测定进行不确定度评定,为建立有效的质量控制方法提供参考。方法通过建立紫外分光光度法、滴定法测定数学模型,分析测量过程,确定不确定度来源、合成不确定度。结果氨茶碱片中无水茶碱含量测定其合成不确定度u(c)=0.40%,扩展不确定度U=0.80%(k=2);氨茶碱片中乙二胺含量测定其合成不确定度u(c)=0.02%,扩展不确定度U=0.04%(k=2)。结论影响氨茶碱片中无水茶碱含量测量结果不确定度的主要因素为样品吸光度,影响氨茶碱片中乙二胺含量测量结果不确定度的主要因素为测量重复性。OBJECTIVE Through the uncertainty evaluation of the content determination of a minophylline tablets,it provides a reference for the establishment of an effective quality control method.METHODS Through the establishment of the mathematical model of ultraviolet spectrophotometry and titration,the source and synthesis of the uncertainty were determined.RESULTS The content of anhydrous theophylline in a minophylline tablets was deter mined.The uncertainty of synthesis was u(c)=0.40%,and the uncertainty of expansion was U=0.80%(k=2).The uncertainty of synthesis was u(c)=0.02%,and the uncertainty of expansion was U=0.04%(k=2).CONCLUSION The main factor affecting the uncertainty of the content of anhydrous theophylline in a minophylline tablets is the sample absorbance,and the main factor influencing the uncertainty of the content of ethylenedia mine in a minophylline tablets is the measurement repeatability.

关 键 词：氨茶碱片 含量 不确定度 

分 类 号：R927[医药卫生—药学]