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酸碱滴定法测定白芷药材中二氧化硫含量的不确定度评定

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目的 建立酸碱滴定法测定白芷药材中二氧化硫含量不确定度的评定方法。方法 参照 2020 年版《中国药典(四部)》,采用酸碱滴定法测定白芷药材中二氧化硫的含量,确定计算公式,对试验过程中引入的不确定度进行分析与评定。结果 合成标准不确定度为 0。427%。平行测定白芷药材二氧化硫残留量分别为 92。3 mg/kg和 91。8 mg/kg;当置信水平为 95%、包含因子k=2 时,白芷药材二氧化硫真实残留量为(92。0±0。6)mg/kg。结论 检测结果的不确定度主要为样品滴定过程引入,其次为基准物质的称量,以及吸管、滴定管引入。
Uncertainty Evaluation of Content Determination of Sulfur Dioxide in Angelicae Dahuricae Radix by Acid-Base Titration
Objective To establish an evaluation method for the uncertainty of content determination of sulfur dioxide in Angelicae Dahuricae Radix by the acid-base titration method.Methods Based on the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),the content of sulfur dioxide in Angelicae Dahuricae Radix was determined by the acid-base titration method,the calculation formula was determined,and the uncertainty introduced during the experimental process was analyzed and evaluated.Results The uncertainty of synthetic standard was 0.427%.The parallel determination of sulfur dioxide residue in Angelicae Dahuricae Radix was 92.3 mg/kg and 91.8 mg/kg,respectively.When the confidence level was 95%and the inclusion factor k was 2,the true sulfur dioxide residue in Angelicae Dahuricae Radix was(92.0±0.6)mg/kg.Conclusion The uncertainty of content determination is mainly introduced by the sample titration process,followed by the weighing of the reference substance,pipette and burette.

sulfur dioxideacid-base titrationAngelicae Dahuricae Radixuncertainty

曾凡玉、李璐晏、周维婷、肖礼娥

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太极集团重庆中药二厂有限公司,重庆 402284

太极集团重庆涪陵制药厂有限公司,重庆 408107

二氧化硫 酸碱滴定法 白芷 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(18)