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。
Objective ： To establish a mathematical model to evaluate the uncertainty in dissolution test of Iron Pol- ysaccharide Complex Capsules. Methods： The factors affecting the uncertainty in the solution preparation process and determination with the instrmnent were analyzed and evaluated. Results： An uncertainty model for the dissolu- tion of Iron Polysaceharide Complex Capsules by Ultraviolet-Visible spectroscopy was established, and the expanded uncertainty was 5.2% with the coverage factor as 2. Conclusion：This experiment provides a scientific basis and methodology support for the uncertainty in dissolution test of Iron Polysaceharide Complex Capsules by Ultraviolet- Visible spectroscopy.
出处
《中国药品标准》
CAS
2017年第6期416-422,共7页
Drug Standards of China
关键词
不确定度
紫外-可见分光光度法
多糖铁
溶出度
uncertainty
Ultraviolet-Visible spectroscopy
polysaccharide iron
dissolution
