党参水分二法测量结果的不确定度评定及在能力比对中的运用

The uncertainty assessment and the application in the ability comparison of the result for Codonopsis Radix measured by lose on drying method

目的探讨被测量饮片的水分数据与真实数据的不确定度,并利用其进行能力比对。方法按照2020年版《中国药典》第一版通则0832水分测定法第二法烘干法对党参水分进行测定,评估不确定度来源,计算水分二法的测量扩展不确定度。参考CNAS-GL02:2014《能力验证结果的统计处理和能力评价指南》中利用测量不确定度进行实验室内部能力比对。结果在用水分二法测定党参水分的过程中,当供试品水分为12.13%时,扩展不确定度为0.34%(k=2),结果表示为(12.13±0.34)%(k=2)。能力比对值=0.305(≤1),比对结果满意。结论在运用水分二法测定党参的不确定度实验中,该方法的重复性因素对不确定度的贡献最大。其次是烘箱的恒重因素,但天平称量因素对不确定度的影响最少。不同实验人员测定的不确定度结果可用于能力比对的计算中。可通过一定的质量控制手段降低实验的不确定度。

Objective To explore the uncertainty between the moisture data of the measured slice and the real data,and perform the ability comparison.Methods Based on the 2nd drying method of the Water Determination Method in Section 0832 of General Article in the 2020 Chinese Pharmacopoeia General Provisions,measured the moisture of Codonopsis Radix,evaluated the source of uncertainty and calculated the measurement expansion uncertainty of the lose on drying method.Referenced CNAS-GL02:2014 Guidance in Statistical Processing and Evaluation of Competence results to measure the uncertainty for in-house capability comparison.Results In the process in assessing the water content of Codonopsis Radix by the lose on drying method,when the supply water was 12.13%,the spread uncertainty was 0.34%(k=2),and the result was(12.13±0.34)%(k=2),and the En was 0.305(En≤1),which was satisfactory.Conclusion In the research of the uncertainty measured by lose on drying method,the repeatability factor of this method contributes the most to the uncertainty and the second is the constant weight factor,but the weighing factor of the balance has the least influence on the uncertainty.The uncertainty assessed by different researchers can be used in the calculation of competency comparisons.The uncertainty of the experiment can be reduced by certain quality control measures.