中国药物评价2026，Vol.43Issue(1)：18-23,6.
HPLC法测定何首乌能力验证样品二苯乙烯苷含量的不确定度评定及Z值分析
Uncertainty Evaluation and Z-Value Analysis for Determination of the Content of Stilbene Glucoside in Proficiency Testing Samples of Polygonum multiflorum by HPLC
李旭 1何枭宇 1赵平华 1尚晓艳1
作者信息
- 1. 荆门市食品药品质量检验所,湖北荆门 448000
- 折叠
摘要
Abstract
Objective:To evaluate the measurement uncertainty of high-performance liquid chromatography(HPLC)in determining stilbene glucoside content in Polygonum multiflorum and assess the proficiency testing outcomes.Methods:Following the chromatographic analytical method for stilbene glucoside quantification documented in Volume Ⅰ of the Chinese Pharmacopoeia(2020 edition),this study established a mathematical model for the analytical process.Potential influencing factors throughout the testing procedure were comprehen-sively analyzed through systematic quantification,ultimately enabling calculation of both combined relative standard uncertainty and expanded uncertainty parameters.Results:At the 95％confidence level,the synthetic standard uncertainty of HPLC method for determining the content of stilbene glucoside in Polygonum multiflorum is 0.1％,the expanded uncertainty is 0.2％,and the validation result is expressed as(2.9±0.2)％;k=2,0≤|Z|≤0.54.Conclusion:The main sources of uncertainty in this method are the purity,weighting and solu-tion preparation of the reference substance of stilbene glucoside,as well as the weighing and pretreatment of the test sample.By evaluating uncertainty,it is possible to identify and prevent risk links in testing,providing reference for improving the accuracy of testing results.关键词
高效液相色谱法/何首乌/二苯乙烯苷/不确定度/Z值Key words
High performance liquid chromatography/Polygonum multiflorum/Stilbene glucoside/Uncertainty/Z-value分类
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李旭,何枭宇,赵平华,尚晓艳..HPLC法测定何首乌能力验证样品二苯乙烯苷含量的不确定度评定及Z值分析[J].中国药物评价,2026,43(1):18-23,6.
