HPLC-ELSD测定人参归脾丸中黄芪甲苷含量的不确定度评估  

Measurement Uncertainty Evaluation for Determination of AstragalosideⅣin Renshen Guipi Pills by HPLC-ELSD

作　　者：王燕[1] 李正刚 曲涵婷 赵磊[1] 王路宏[1] 马彧[1] WANG Yan;LI Zhenggang;QU Hanting;ZHAO Lei;WANG Luhong;MA Yu(Siping Institute for Food and Drug Control,Jilin Siping 136000,China;Siping Social Psychiatric Hospital,Jilin Siping 136000,China)

机构地区：[1]四平市食品药品检验所,吉林四平136000 [2]四平市社会精神病院,吉林四平136000

出　　处：《中国医药导刊》2022年第11期1142-1146,共5页Chinese Journal of Medicinal Guide

基　　金：吉林省科技厅项目-重点研发-医药健康领域(项目编号:20210204151YY,项目名称:含人参类系列中成药人参归脾丸和小儿健脾丸质量标准提升、制剂工艺改进及增加产品规格)。

摘　　要：目的:评估高效液相色谱-蒸发光散射法(HPLC-ELSD)测定人参归脾丸中黄芪甲苷含量的不确定度。方法:参照国家计量技术规范JJF1135-2005《化学分析测量不确定度评定》和JJF 1059.1-2012《测量不确定度评定与表示》,依据标准曲线法测定原理分步建立数学模型,结合HPLC-ELSD测定人参归脾丸中黄芪甲苷含量的实验过程,系统分析不确定度来源,基于方法学验证数据评估不确定度分量,最终计算合成不确定度与扩展不确定度。结果:人参归脾丸样品中黄芪甲苷含量测定的扩展不确定度为3.8μg·g^(-1),k=2;含量测定结果可以表示为(103.4±3.8)μg·g^(-1),k=2。结论:本研究建立了HPLC-ELSD检测人参归脾丸中黄芪甲苷含量的不确定度评定方法,为提高检测质量提供理论指导,为人参归脾丸的质量控制提供科学依据。Objective:To evaluate the measurement uncertainty for determination of astragalosideⅣin renshen guipi pills by HPLC-ELSD.Methods:With reference to JJF 1135-2005 Evaluation of Uncertainty in Chemical Analysis Measurement and JJF 1059.1-2012 Evaluation and Expression of Uncertainty in Measurement,the mathematical models were established according to the principle of standard curve method,the source of measurement uncertainty was systematically analyzed combined with the experimental process of the determination of astragalosideⅣin renshen guipi pills by HPLC-ELSD,the uncertainty components were evaluated based on methodological verification data,and the combined standard uncertainty and expanded uncertainty were calculated finally.Results:The extended uncertainty for the determination of astragalosideⅣin renshen guipi pills was 3.8μg·g^(-1),k=2,and the content determination result can be expressed as(103.4±3.8)μg·g^(-1),k=2.Conclusion:A feasible method of measurement uncertainty evaluation for determination of astragalosideⅣin renshen guipi pills by HPLC-ELSD was established.It could provide theoretical guidance for improving detection quality,and provide scientific grounds for the quality control of renshen guipi pills.

关 键 词：人参归脾丸 黄芪甲苷 高效液相色谱-蒸发光散射法 测量不确定度 

分 类 号：R917[医药卫生—药物分析学]