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浸渍法测量高密度聚乙烯瓶密度的不确定度评定 被引量:2

Uncertainty Evaluation in the Density Determination of HDPE Bottles for Oral Solid Preparation by Impregnation Method
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摘要 目的研究浸渍法测量高密度聚乙烯瓶密度的不确定度来源。方法采用浸渍法对同批口服固体药用高密度聚乙烯瓶的密度重复进行了多次测量,分析了测量不确定度来源,并画出了来源因果图;建立了测量模型,对影响测量结果的各个不确定度分量分别进行了评定,并计算了合成标准不确定度和扩展不确定度。结果被测量的同批次口服固体药用高密度聚乙烯瓶密度为(0.950±0.002)g/cm3,其分散性在±0.002 g/cm3之间,符合规定。结论测量过程中对测得值影响较大的非重复性因素为浸渍液温度。 The aim of this study was to study the uncertainty sources for density measurements of HDPE bottles by impregnation method. Impregnation method was used to repeatedly measure the same batch of HDPE bottles for oral solid medicine, the measurement uncertainty sources were analyzed and the cause-effect diagram was depicted. A measurement model was established, each of the contributors to the uncertainty of the measurement results was evaluated respectively, and the combined standard uncertainty of the density measurement was calculated as well as the expanded uncertainty. The density of the HDPE bottles for oral solid medicine was measured to be ( 0.950± 0.002 ) g/cm3, with a dispersion between±0.002 g/cm3, which conformed the national standard. The main contributor to the type B uncertainty of the density measurement was the auxiliary liquid temperature.
作者 范艳芳
出处 《包装工程》 CAS CSCD 北大核心 2016年第1期15-18,88,共5页 Packaging Engineering
关键词 测量不确定度 浸渍法 口服固体药用高密度聚乙烯瓶 密度 measurement uncertainty impregnation method high-density polyethylene bottles for oral solid prepara-tion density
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  • 1李慎安,曾凡平.测量不确定度理解与应用 测量不确定度评定中的重复性分量问题[J].中国计量,2005(2):65-65. 被引量:7
  • 2苏芬丽,周志凌,李焕德.HPLC-MS法检测利培酮与9-羟利培酮的血浆浓度及在临床药动学的应用[J].药物分析杂志,2006,26(2):207-211. 被引量:8
  • 3.GJB3756-99.测量不确定度的表示及评定[S].,.. 被引量:1
  • 4State Quality and Technique Administration (国家质量技术监督局) . Guide of Evaluation and Exp ression of Uncertainty in Measurement (测量不确定度评定与表示).JJF1059-1999. 被引量:1
  • 5Etienne Cavalier,Eric Rozet, Nathalie Dubois, et al. Performance of iohexol determination in serum and urine by HPLC:Validation,risk and uncertainty assessment. Clin Chim Acta ,2008,396:80. 被引量:1
  • 6De Beer J O, Baten P, Nseugyumva C, et al. Measurement uncertainty from validation and duplicate analysis results in HPLC analysis of multivitamin preparations and nutrients with different galenie forms. J Pharm Biomed Anal, 2003,32:767. 被引量:1
  • 7Gaudiano M C, Di Maggio A,Antoniella E,et al. An LC method for the simultaneous screening of some common counterfeit and sub - standard antibiotics validation and uncertainty estimation. J Pharm Bionued Anal, 2008,48:303. 被引量:1
  • 8JJF1059-1999.测量不确定度评定与表示.[S].国家质量技术监督局发布,1999-05-01实施.. 被引量:255
  • 9ISO/IEC17025.检测和校准实验室能力的通用要求.[S].,.. 被引量:4
  • 10国家质量技术监督局.JJF1059-1999测量不确定度评定与表示[M].北京:中国计量出版社,1999.8-10. 被引量:38

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