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南葶苈子膨胀度的不确定度评定

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目的 建立中药南葶苈子膨胀度测定的不确定度评定方法。方法 按 2020 年版《中国药典(四部)》通则 2101 膨胀度测定法测定膨胀度,分析测定过程中的不确定度来源,量化不确定度分量。结果 测定过程中的不确定度来源于药材样品膨胀后的体积、称量、水分测量的相对不确定度,以及膨胀度测量重复性的标准不确定度。所得扩展不确定度为 0。3mL/g,南葶苈子膨胀度为(5。5±0。3)mL/g。结论 在现行膨胀度测定法的基础上,建议修订膨胀度测定管的刻度分度(如由 0。2 mL改为 0。1 mL),"称定质量"项由精确至0。01g改为 0。001 g,以提高南葶苈子膨胀度测定结果的可靠性。
Uncertainty Evaluation of Swelling Degree of Descurainiae Semen
Objective To establish an uncertainty evaluation method for the swelling degree of Descurainiae Semen.Methods The swelling degree was determined based on the general rule 2101(swelling degree determination)of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),the uncertainty sources during the determination process were analyzed,and the uncertainty components were quantified.Results The uncertainty in the determination process were from the relative uncertainty of the volume swelling of the medicinal materials,the weighing and the measurement of moisture,as well as the standard uncertainty of the repeatability of the swelling degree measurement.The determined expanded uncertainty was 0.3 mL/g,and the swelling degree of Descurainiae Semen was(5.5±0.3)mL/g.Conclusion Based on the current swelling degree measurement method,it is suggested that we should revise the scale division of the swelling degree measurement tube(such as changing from 0.2 mL to 0.1 mL),improve the accuracy of the ″mass measurement ″ from 0.01 g to 0.001 g to increase the reliability of the swelling degree measurement of Descurainiae Semen.

Descurainiae Semenswelling degreeuncertaintyexpanded uncertainty

翁雪萍、李惠敏、朱文娟

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广东省惠州市食品药品检验所,广东 惠州 516003

南葶苈子 膨胀度 不确定度 扩展不确定度

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(4)
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