成分分析

ICP-MS 法结合化学计量学用于枸杞子道地性的研究及安全性评价*

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  • 1.中国食品药品检定研究院, 北京 102629;
    2.河北中医学院药学院, 石家庄, 050200
第一作者: 左甜甜 Tel: (010)53851753;E-mail: zuotiantian2011@163.com
**康 帅 Tel: (010)67095452;E-mail: kangshuai@nifdc. org. cn; 马双成 Tel: (010)53832076;E-mail: masc@nifdc. org. cn

修回日期: 2021-01-13

  网络出版日期: 2024-05-31

基金资助

*国家药典委员会药品医疗器械审评审批制度改革项目 (ZG2016-1)

Holistic strategy of study on authenticity and safety evaluation of Chinese wolfberry by ICP-MS combined with chemometrics*

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  • 1. National Institutes for Food and Drug Control, Beijing 102629, China;
    2. College of Pharmacy, Hebei University of Chinese Medicine, Shijiazhuang 050200, China

Revised date: 2021-01-13

  Online published: 2024-05-31

摘要

目的: 研究枸杞子中重金属及有害元素与道地性的相关性, 并首次提出一种用于道地药材安全性评价的综合性策略。方法: 该策略涵盖样品收集、分析测定、多元统计分析、安全性评价和风险评估5 个步骤。样品经过微波消解后, 采用电感耦合等离子体质谱(ICP-MS)法测定其重金属及有害元素的残留量, 对结果进行聚类热图分析、主成分分析(PCA)和自组织映射人工神经网络(SOM)等多元统计分析。通过单因子污染指数法和内梅罗综合污染指数法对其进行安全性评价, 并根据风险评估的4 个基本步骤, 对于其健康风险进行评估。结果: 3 个产地枸杞子中铅、镉、砷、汞、铜的平均含量分别为0. 30、 0. 066、0. 05、0. 003、6. 71 mg·kg-1。聚类分析和主成分分析结果表明, 33 批样品被分成3 组, 同一产地的样品基本能够较好地聚在一起, 样品在神经元空间的映射结果与PCA 分析结果相一致, 药材品种与产地分布存在一定的规律性。安全性评价结果说明来自所有产地的枸杞子的铅、镉、砷、汞、铜的单因子指数均小于0. 7, 综合污染指数范围为0. 11~0. 51, 污染状况均处于安全。风险评估结果表明不同产地的枸杞子样品中重金属及有害元素的健康风险均可以被接受。结论: 本研究所建立的方法可准确、高效地分析、评价不同产地枸杞子中重金属及有害元素, 为药材的道地性评价提供一种新的研究策略和模式。

本文引用格式

左甜甜, 金红宇, 余坤子, 康帅, 马双成 . ICP-MS 法结合化学计量学用于枸杞子道地性的研究及安全性评价*[J]. 药物分析杂志, 2021 , 41(3) : 394 -401 . DOI: 10.16155/j.0254-1793.2021.03.03

Abstract

Objective: The correlation between heavy metals and harmful elements and the genuineness of Chinese wolfberries was studied, and a comprehensive strategy for the safety evaluation of authentic medicines was put forward for the first time. Methods: The strategy contained five steps, including sample collection, analysis and determination, multivariate statistical analysis, safety evaluation and risk assessment. After microwave digestion, lead, cadmium, arsenic, mercury and copper contents in Chinese wolfberries were determined by inductively coupled plasma mass spectrometry (ICP-MS). The results were analyzed by cluster analysis, principal component analysis (PCA) and self-organizing map clustering. And the safety was evaluated by single factor pollution index method and Nemerow comprehensive pollution index methods. Furthermore, based on the four basic steps of risk assessment, the health risk of the heavy metal and harmful elements in the samples was assessed. Results: The average contents of lead, cadmium, arsenic, mercury and copper in Chinese wolfberries from three origins was 0. 30, 0. 066, 0. 05, 0. 003, 6. 71 mg· kg-1, respectively. Cluster analysis and PCA showed that 33 batches of samples were divided into three groups, and the samples from the same origins were clustered into the same group. The results of self-organizing map clustering were consistent with that of PCA. Regularities between the distribution of Chinese wolfberries and origins could be found. The results of safety evaluation showed that the single factor index of lead, cadmium, arsenic, mercury and copper in all the samples was less than 0. 7, and the comprehensive pollution index ranged from 0. 11 to 0. 51, which indicated that the pollution situation was safe. The results of risk assessment indicated that the health risk of heavy metals and harmful elements in samples from different origins was acceptable. Conclusion: The method established in this study can accurately and efficiently evaluate the heavy metals and harmful elements in Chinese wolfberries from different origins. And the study provides a novel model for the genuineness evaluation of Chinese medicinal materials.

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