吸入麻醉剂异氟烷相对密度测量不确定度评定
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摘要
目的:建立测定同分异构体异氟烷、恩氟烷相对密度的测量不确定度评定方法,以控制产品质量。方法:通过建立数学模型、绘制因果图,分析测锤体积、横梁分度间距、重复性、温度示值、温度波动等影响测量挥发性液体相对密度不确定度的各种因素并计算各不确定度分量,对测量异氟烷、恩氟烷相对密度的不确定度进行评估。结果:计算出总合成不确定度,给出测定结果的扩展不确定度和包含因子。由测锤体积和横梁分度间距引入的相对密度不确定度是影响相对密度测量的主要因素,由温度示值对相对密度的影响相对较小。结论:建立的评定方法可用于韦氏天平法测定吸入麻醉剂相对密度的不确定度评定。同分异构体异氟烷、恩氟烷的相对密度值相差较小,温度波动是影响测定的主要因素。
Objective: To establish a method for uncertainty analyses in relative density of Isoflurane and Enfluane determined by Westphal balance method to make the quality under controlled.Methods: It was established a model of mathematics based on the determination of relative density by Westphal balance method,and calculated various components of standard uncertainty by analyzing uncertainty sources such as weight system,space of beam graduation,repeatability of balance,temperature,etc.Results: A combined standard uncertainty and expanded standard uncertainty was finally obtained by combining all standard uncertainty.The uncertainty derived from weight system and space of beam graduation was greater than other uncertainty components such as indicating value of thermometer.Conclusion: It was established to evaluate major sources of measurement uncertainty of relative density determination by Westphal balance method.Temperature range was became major source for inhalation anesthetics Isoflurane and Enflurane,a pair of isomer.
Objective: To establish a method for uncertainty analyses in relative density of Isoflurane and Enfluane determined by Westphal balance method to make the quality under controlled.Methods: It was established a model of mathematics based on the determination of relative density by Westphal balance method,and calculated various components of standard uncertainty by analyzing uncertainty sources such as weight system,space of beam graduation,repeatability of balance,temperature,etc.Results: A combined standard uncertainty and expanded standard uncertainty was finally obtained by combining all standard uncertainty.The uncertainty derived from weight system and space of beam graduation was greater than other uncertainty components such as indicating value of thermometer.Conclusion: It was established to evaluate major sources of measurement uncertainty of relative density determination by Westphal balance method.Temperature range was became major source for inhalation anesthetics Isoflurane and Enflurane,a pair of isomer.
引文
1国家药典委员会.中华人民共和国药典.2010年版.二部.北京:中国医药科技出版社,2010.
2国家质量监督检验检疫总局.JJG171-2004液体相对密度天平,北京:中国计量出版社,2004.
3国家质量监督检验检疫总局.JJG130-2004工作用玻璃液体温度计,北京:中国计量出版社,2004.
4国家质量技术监督局.JJF1059-1999测量不确定度评定与表示,北京:中国计量出版社,1999.
5中国药品生物制品检定所.中国药品检验标准操作规范.2010年版.北京:中国医药科技出版社,2010.
6国家质量监督检验检疫总局、国家标准化管理委员会.GB/T611-2006化学试剂密度测定通用方法.中国标准出版社,2006.
2国家质量监督检验检疫总局.JJG171-2004液体相对密度天平,北京:中国计量出版社,2004.
3国家质量监督检验检疫总局.JJG130-2004工作用玻璃液体温度计,北京:中国计量出版社,2004.
4国家质量技术监督局.JJF1059-1999测量不确定度评定与表示,北京:中国计量出版社,1999.
5中国药品生物制品检定所.中国药品检验标准操作规范.2010年版.北京:中国医药科技出版社,2010.
6国家质量监督检验检疫总局、国家标准化管理委员会.GB/T611-2006化学试剂密度测定通用方法.中国标准出版社,2006.