中国药物评价Issue(3):132-134,138,4.
比重瓶法检测口服固体药用高密度聚乙烯瓶密度测量不确定度分析
Measurement Uncertainty Analysis of Density in Oral Solid Pharmaceutical High-density Polyethylene Bottles by Pycnometer Method
摘要
Abstract
Objective:To analyze the measurement uncertainty of density in oral solid pharmaceutical high-density polyethylene bot-tles by pycnometer method.Methods:The uncertainty of measurement in detecting of density in oral solid pharmaceutical high-density polyethylene bottles can be reasonably estimated according to the standard YBB00122002 and Evaluation and Expression of Uncertainty in Measurement(JJF1059.1-2012),the sources of each uncertainty component were identified,evaluation of the uncertainty components and then a combined standard uncertainty was calculated,finally an expanded uncertainty was given.Results:The testing results of measure-ment uncertainty of density in oral solid pharmaceutical high-density polyethylene bottles can be reported as 0.951 g・ cm3 ,the expanded uncertainty was 0.014 g・ cm3 with a coverage factor of 2.Conclusion:The method described in this research may be used to analyze con-tribution of various components of uncertainty on measurement,it is significant to improve the quality of drug packaging materials and con-tainers.关键词
比重瓶法/口服固体药用高密度聚乙烯瓶/密度/测量不确定度Key words
Pycnometer method/Oral solid pharmaceutical high-density polyethylene bottles/Density/Measurement uncertainty分类
医药卫生引用本文复制引用
张兴哲,贾瑞波,赵丽元,贺建华..比重瓶法检测口服固体药用高密度聚乙烯瓶密度测量不确定度分析[J].中国药物评价,2015,(3):132-134,138,4.