不确定度评定在川牛膝中杯苋甾酮含量测定中的应用  

Application of Uncertainty Evaluation to the Determination of Content of Cyasterone in Cyathula officinalis Kuan

作　　者：李晓敏 张文涛 孙艳涛 LI Xiao-min;ZHANG Wen-tao;SUN Yan-tao(Zibo Food and Drug Inspection Institute,Zibo 255086,China)

机构地区：[1]淄博市食品药品检验研究院,山东淄博255086

出　　处：《海峡药学》2025年第1期22-26,共5页Strait Pharmaceutical Journal

基　　金：淄博市科技型中小企业创新能力提升工程计划项目(2023tsgc0028)。

摘　　要：目的评定高效液相色谱测定川牛膝中杯苋甾酮含量的不确定度。方法采用高效液相色谱法测定川牛膝中杯苋甾酮的含量,通过建立相应的数学分析模型,探讨在检测过程中出现的不确定度并分析其来源,评定和量化检测过程中出现的各种不确定度,最后得出扩展不确定度。结果川牛膝中杯苋甾酮的含量为:0.057%,杯苋甾酮含量的扩展不确定度为0.00114%,川牛膝中杯苋甾酮的含量应表述为:0.057%±0.00114%。结论川牛膝中杯苋甾酮含量测定的不确定度主要来源于杯苋甾酮对照品溶液的配制和加标样回收过程,严格控制这些试验过程,能够增加检验结果的准确性,优化实验室的检验检测结果,为试验检测结果的可靠性提供了参考依据。OBJECTIVE The uncertainty of the Cyasterone content in Cyathula officinalis Kuan was evaluated by HPLC.METHODS HPLC was used to determine the content of cyasterone in Cyathula officinalis Kuan.The corresponding mathematical analysis model was established to analyze the source of uncertainty in the process of measurement,evaluating and quantifying of various uncertainties in the process of testing,finally,the expanded uncertainty is obtained.RESULTS The content of cyasterone in cyathula officinalis Kuan was 0.057%,and the expanded uncertainty of the cyasterone content was 0.00114%.The content of cyasterone in Cyathula officinalis kuan should be expressed as 0.057%±0.00114%.CONCLUSION The uncertainty of the determination of the cyasterone content in Cyathula officinalis Kuan is mainly derived from the preparation of the reference solution and the process of sample addition recovery test.Strictly controlling these test processes can increase the accuracy of test results and optimize the laboratory's test detection results,providing reference basis for the reliability of test detection results.

关 键 词：不确定度 川牛膝 杯苋甾酮 高效液相色谱 

分 类 号：R927[医药卫生—药学]