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作 者:曾凡玉 李璐晏 周维婷 肖礼娥 ZENG Fanyu;LI Luyan;ZHOU Weiting;XIAO Li'e(Taiji Group Chongqing NO.2 Chinese Medicine Factory Co.,Ltd.,Chongqing,China 402284;Taiji Group Chongqing Fuling Pharmaceutical Factory Co.,Ltd.,Chongqing,China 408107)
机构地区:[1]太极集团重庆中药二厂有限公司,重庆402284 [2]太极集团重庆涪陵制药厂有限公司,重庆408107
出 处:《中国药业》2024年第18期75-77,共3页China Pharmaceuticals
摘 要: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。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,VolumeⅣ),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.
分 类 号:R917[医药卫生—药物分析学] O651[医药卫生—药学]
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