基于UPLC的苏合香中肉桂酸-3-苯基丙酯含量的不确定度研究  

Evaluation of Uncertainty in Measurement of 3-Phenylpropyl Cinnamate in Styrax by UPLC

作　　者：郭晓晗 丁一明 张宇 荆文光 李明华[1] 康帅[1] 程显隆[1] 魏锋[1] GUO Xiaohan;DING Yiming;ZHANG Yu;JING Wenguang;LI Minghua;KANG Shuai;CHENG Xianlong;WEI Feng(National Institutes for Food and Drug Control,Beijing 102629,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100029,China;Faculty of Functional Food and Wine,Shenyang Pharmaceutical University,Shenyang 117004,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]北京中医药大学中药学院,北京100029 [3]沈阳药科大学功能食品与葡萄酒学院,辽宁沈阳117004

出　　处：《中国现代中药》2025年第3期426-431,共6页Modern Chinese Medicine

基　　金：中国食品药品检定研究院中青年发展研究基金项目(2023A2)。

摘　　要：目的:采用超高效液相色谱法(UPLC)测定苏合香中肉桂酸-3-苯基丙酯含量的不确定度。方法:通过分析样品前处理、测试过程,确定并简化影响不确定度的因素;利用UPLC测定苏合香中肉桂酸-3-苯基丙酯含量的方法学验证数据及样品代表性试验数据,通过统计学方法量化不确定度分量;计算合成不确定度和扩展不确定度。结果:建立了UPLC测定苏合香中肉桂酸-3-苯基丙酯含量的不确定度评定方法,当置信概率为95%、包含因子(k)=2时,其相应的扩展不确定度为16.19%。苏合香中的水分、误差引入的不确定度分量为合成不确定度的主要贡献量,而对照品纯度的影响最小。应注意样品保存的环境及仪器、量器的定期检定和维护等,以减小测量结果的不确定度。结论:研究结果为提高检测质量提供理论指导,为苏合香的质量控制提供科学依据。Objective:To evaluate the uncertainty in the measurement of 3-phenylpropyl cinnamate in Styrax by ultra-performance liquid chromatography(UPLC).Methods:The factors affecting the uncertainty were identified and simplified by analyzing the sample pretreatment and measurement processes.The uncertainty components were quantified by statistical methods with the validation data of the UPLC method for measuring 3-phenylpropyl cinnamate in Styrax and the representative test data of the samples.The combined uncertainty and expanded uncertainty were calculated.Results:A method was established for evaluating the uncertainty in the measurement of 3-phenylpropyl cinnamate in Styrax by UPLC.The expanded uncertainty was 16.19%in the case of the confidence probability being 95%and the coverage factor k=2.The uncertainty components introduced by water and error in Styrax were the main contributors to the combined uncertainty,while the purity of the reference material had the least effect.Attention should be paid to the environment of sample preservation as well as the regular calibration and maintenance of instruments and gauges to minimize the uncertainty of the measurement results.Conclusion:The results provide theoretical guidance to improve the measurement quality and a scientific basis for the quality control of Styrax.

关 键 词：苏合香 测量不确定度 超高效液相色谱法 肉桂酸-3-苯基丙酯 扩展不确定度 

分 类 号：R282[医药卫生—中药学]