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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

张兴哲 贾瑞波 赵丽元 贺建华

中国药物评价Issue(3):132-134,138,4.
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

张兴哲 1贾瑞波 1赵丽元 1贺建华1

作者信息

  • 1. 大连市药品检验所,辽宁大连116021
  • 折叠

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.

中国药物评价

2095-3593

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