文章摘要
黄莹,吴凤如,李静,张小媚.多糖铁复合物胶囊溶出度测定的不确定度评定[J].中国药品标准,2017,18(6):416-422
多糖铁复合物胶囊溶出度测定的不确定度评定
Evaluation on the Uncertainty for the Dissolution of Iron Polysaccharide Complex Capsules
投稿时间:2017-07-20  修订日期:2017-12-12
DOI:
中文关键词: 不确定度,紫外-可见分光光度法,多糖铁,溶出度
英文关键词: uncertainty,Ultraviolet-Visible spectroscopy,polysaccharide iron,dissolution
基金项目:
作者单位E-mail
黄莹 广东省药品检验所 huangying_gdidc@126.com 
吴凤如 广东省药品检验所  
李静 广东省药品检验所  
张小媚 广东省药品检验所  
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中文摘要:
      目的:建立多糖铁复合物胶囊溶出度测定的不确定度评定数学模型。方法 分析来自于溶液配制过程和仪器测定过程的各种不确定度影响因素并对其进行评估。结果 建立了紫外-可见分光光度法测定多糖铁复合物胶囊溶出度的不确定度模型,取包含因子k=2, 扩展不确定度=5.2%。结论 该实验为紫外-可见分光光度法测定多糖铁复合物胶囊溶出度的不确定度评定提供科学依据和方法支持。
英文摘要:
      Objective To establish a mathematical model to evaluate the uncertainty in dissolution measurement of Iron Polysaccharide Complex Capsules. Methods: Analyzing and evaluating the factors affecting the uncertainty in the preparation process of the solution and the measurement by the instrument. Results: An uncertainty model for the dissolution of Iron Polysaccharide Complex Capsules by Ultraviolet-Visible spectroscopy was established, the expanded uncertainty is 5.2% when coverage factor is 2. Conclusion:This experiment provides a scientific basis and methodology support for the uncertainty of . iron polysaccharide Complex Capsules dissolution by using Ultraviolet-Visible spectroscopy determination.
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