南葶苈子膨胀度的不确定度评定  

Uncertainty Evaluation of Swelling Degree of Descurainiae Semen

作　　者：翁雪萍 李惠敏 朱文娟 WENG Xueping;LI Huimin;ZHU Wenjuan(Huizhou Institute for Food and Drug Control,Huizhou,Guangdong,China 516003)

机构地区：[1]广东省惠州市食品药品检验所,广东惠州516003

出　　处：《中国药业》2024年第4期76-79,共4页China Pharmaceuticals

摘　　要：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0.3 mL/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0.01 g改为0.001 g,以提高南葶苈子膨胀度测定结果的可靠性。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,VolumeⅣ),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.

关 键 词：南葶苈子 膨胀度 不确定度 扩展不确定度 

分 类 号：R917[医药卫生—药物分析学]