| 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。 |
| 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 |
| DOI： |
| 分类号:TB484.3；TB487 |
| 基金项目: |
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| Uncertainty Evaluation in the Density Determination of HDPE Bottles for Oral Solid Preparation by Impregnation Method |
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FAN Yan-fang
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Guangzhou Institute for Drug Control， Guangzhou 510160， China
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| Abstract: |
| 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. |
| Key words: measurement uncertainty impregnation method high-density polyethylene bottles for oral solid preparation density |
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