山药水溶性浸出物测定的不确定度评估

Evaluation of Uncertainty in the Determination of Water-Soluble Extracts of Rhizoma Dioscoreae

摘要

采用浸出物测定法对山药水溶性浸出物进行测定，找出影响不确定度的因素，分析不确定度来源，给出分析结果的不确定度，使之符合测量不确定度指南。按照《中华人民共和国药典》2025年版四部通则2201浸出物测定法1.水溶性浸出物测定法中冷浸法测定山药饮片水溶性浸出物含量，依据《不确定度评定与药品检验》中国医药科技出版社2021年；喀什地区食品药品检验所程序文件《测量不确定度评定程序》，建立数学模型，系统分析称量、恒重、容量器具、温度、样品水分及实验重复性等不确定度来源，对各分量进行量化评定与合成，计算扩展不确定度。结果表明，山药饮片水溶性浸出物平均含量为6.00%，扩展不确定度为0.06%（k=2）；实验重复性与蒸发皿恒重是影响不确定度的主要因素。本研究可为山药质量控制、检测结果评价及实验室数据溯源提供科学依据。

Abstract

The water-soluble extracts of Rhizoma Dioscoreae were determined by the extract determination method. The factors affecting the uncertainty were identified, the sources of uncertainty were analyzed, and the uncertainty of the analytical results was given to comply with the guidelines for measurement uncertainty. According to the hot extraction method in the General Principles of Volume IV of the Pharmacopoeia of the People’s Republic of China (2025 Edition), the content of water-soluble extracts of Rhizoma Dioscoreae was determined. Based on Evaluation of Uncertainty and Pharmaceutical Testing (China Medical Science Press, 2021) and the procedural document Procedure for Evaluation of Measurement Uncertainty of the Kashgar Institute for Food and Drug Control, a mathematical model was established. The sources of uncertainty, including weighing, constant weight, volumetric apparatus, temperature, sample moisture and experimental repeatability, were systematically analyzed. Each component was quantitatively evaluated and combined to calculate the expanded uncertainty. The results showed that the average content of water-soluble extracts of Chinese Rhizoma Dioscoreae was 6.00%, with an expanded uncertainty of 0.06% (k=2). Experimental repeatability and constant weight after evaporation were the main factors affecting the uncertainty. This study can provide a scientific basis for the quality control of Chinese Rhizoma Dioscoreae, evaluation of test results and traceability of laboratory data.

关键词

山药 / 水溶性浸出物 / 冷浸法 / 测量不确定度 / 质量评价

Key words

rhizoma dioscoreae / water-soluble extracts / hot extraction method / measurement uncertainty / quality evaluation

参考文献

[1] 崔艺钒, 张璐佳, 丰宇, 等. 山药活性成分及营养功能研究进展[J]. 中国食品学报, 2022, 22(7):2325.

[2] 赵小亮, 龙则宇, 鲁雲, 等. 山药中部分活性物质的功效研究与应用进展[J]. 浙江农业学报, 2024, 36(4):

[3] 田树兴, 丁艳谱, 周崇富, 等. 红景天配方颗粒浸出物测定的测量不确定度评定[J]. 海峡药学, 2025, 37(2):4548.

[4] 杨丽, 苏学秀. 地骷髅水溶性浸出物测定及不确定度分析[J]. 北方药学, 2024, 21(3):2325.

[5] 李钰婷, 武小赟, 王欣, 等. 黄连及其炮制品浸出物测定方法比较研究[J]. 中华中医药杂志, 2011, 26(3):538541