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HPLC法测定科蒂胶囊中腺苷含量的不确定度评估 被引量:2

HPLC measurement of uncertainty evaluation for the determination of adenosine in Kedi capsules
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摘要 目的:依据《化学分析中不确定度的评估指南》要求,对《保健食品检验与评价技术规范》(2003年版)中收载"HPLC法测定保健食品中腺苷含量"方法进行不确定度的评估,探讨不确定度评估的方法,为保健食品质量标准的制定提供科学依据。方法:参照《指南》中"使用实验室内开发和确认研究数据评估不确定度的方法",依据HPLC法测定腺苷含量的方法学研究的多项技术数据,通过建立数学模型,分析不确定度的来源,量化不确定度的分量,计算合成不确定度进行评估。结果:实验重复性是本方法的最大不确定度来源。本实验方法结果的不确定度表述为:U=P±0.05(mg·g-1)(k=2),置信概率95%。结论:本评估方法适用于HPLC法测定保健食品中腺苷含量的测量不确定度评估,避免了不确定度的重复评估,简化了不确定度评估的繁琐程序。 Objective:To evaluating the measurement uncertainty of the determination of adenosine in Kedi capsules by HPLC according to Chemical Analysis of Uncertainty in the Assessment Guidelines. Discussed the different method of evaluating. Method:The use of laboratory confirmed the development and research data to assess the uncertainty method. Based on the data which was acquired from verification methodology for determination of adenosine by HPLC to evaluate the uncertainty. Results:The factors affected on the measurement uncertainties were analyzed. The primary factor that affect to the measurement uncertainty of determination was repeatability experiment. The results of this method of measurement uncertainty expressed as U = P + 0. 05 ( mg · g^-1 ) ( k = 2), probability level is 95%. Conclusion:Simplified method was used in evaluating measurement uncertainty by using data of validation assay experiment in the procedure of in laboratory. This method was applicable to evaluate the determination of a- denosine in Kedi capsules by HPLC.
出处 《药物分析杂志》 CAS CSCD 北大核心 2009年第6期979-983,共5页 Chinese Journal of Pharmaceutical Analysis
关键词 保健食品 HPLC 方法学验证 测量不确定度评估 health food HPLC verification methodology measurement uncertainty evaluation
作者简介 Tel:(010)67095313;E—mail:yanhua1502@yahoo.com.cn
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  • 1WEIHao(魏昊).Chemical Analysis of the Uncertainty in the Assessment Guidelines(化学分析中不确定度的评估指南).Beijing(北京):China Measurement Press(中国计量出版社),2004.16.
  • 2Health Food Testing and Evaluation of the Technical Specifications(保健食品检验与评价技术规范)Vol.2003,Ministry of Health(卫生部) .
  • 3JJG196 -2006 Common Used glass container certification order ( JJG196 - 2006 ) Used glass container certification order (常用玻璃量器检定规程).

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