中国药物警戒 ›› 2024, Vol. 21 ›› Issue (9): 1008-1013.
DOI: 10.19803/j.1672-8629.20240039

• 基础与临床研究 • 上一篇    下一篇

电感耦合等离子体质谱法测定麸炒薏苡仁中28种元素其风险评估

郭愿生1,2, 左甜甜1△, 刘丽娜1, 魏锋1, 董喆1, 李静1, 金红宇1#, 马双成3,*   

  1. 1中国食品药品检定研究院中药民族药检定所,北京 100050;
    2中国药科大学中药学院,江苏 南京 211198;
    3国家药典委员会,北京 100061
  • 收稿日期:2024-01-19 出版日期:2024-09-15 发布日期:2024-09-14
  • 通讯作者: *马双成,男,研究员,中药质量控制。E-mail: masc@nifdc.org.cn。#为共同通信作者。
  • 作者简介:郭愿生,男,在读硕士,中药质量控制。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2022YFC3501500）; 2023年度国家药品标准制修订研究课题（2023Z07）

Twenty-eight elements in Coicis Semen and risk assessment by stir-frying with bran by inductively coupled plasma-mass spectrometry

GUO Yuansheng1,2, ZUO Tiantian1△, LIU Li'na1, WEI Feng1, DONG Zhe1, LI Jing1, JIN Hongyu1#, MA Shuangcheng3,*   

  1. 1Institute for Contral of Chinese Traditinal and Ethnic Medicine, National Institutes for Food and Drug Control, Beijing 100050, China;
    2School of Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 211198, China;
    3Chinese Pharmacopoeia Commission, Beijing 100061, China
  • Received:2024-01-19 Online:2024-09-15 Published:2024-09-14

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摘要： 目的 建立麸炒薏苡仁中28种元素的含量测定方法,并对其中有害元素的风险进行评估,为麸炒薏苡仁的质量监测提供参考。方法 15批麸炒薏苡仁样品经微波消解处理后,采用电感耦合等离子体质谱法（ICP-MS）对样品中的28种重金属及微量元素进行分析,在此基础上对麸炒薏苡仁的健康风险进行评估。结果 麸炒薏苡仁中各元素的线性关系良好;精密度均小于3%;回收率81.2%~112.0%;其中钾（K）、镁（Mg）、钙（Ca）、铁（Fe）、锌（Zn）、锰（Mn）、铝（Al）、钠（Na）含量较高（>50 mg·kg-1）,铜（Cu）、硼（B）、镍（Ni）、钡（Ba）、锶（Sr）、钼（Mo）、铬（Cr）、钛（Ti）含量较低（1~5 mg·kg-1）,钒（V）、硒（Se）、钴（Co）、砷（As）、铅（Pb）、铍（Be）、镉（Cd）、银（Ag）、铊（Tl）、金（Au）、汞（Hg）、锑（Sb）为痕量元素（<1 mg·kg-1）;按照《中华人民共和国药典》（2020年版）（一部）中关于植物药重金属及有害元素的限量标准,15批麸炒薏苡仁药材中Pb、Cd、As、Hg、Cu的合格率为100%。风险评估表明,15批麸炒薏苡仁中Pb、Cd、As、Hg、Cu的危害指数（HI）均小于1,表明风险可被接受。结论 本文所建立的多元素分析方法灵敏度高,专属性好,结合风险评估技术,可为麸炒薏苡仁的质量监测提供参考。

关键词: 麸炒薏苡仁, 元素, 电感耦合等离子体质谱法, 含量测定, 风险评估

Abstract: Objective To establish a method for determination of 28 elements in Coicis Semen by stir-frying with bran, and evaluate the risks of these toxic elements in order to facilitate quality control of Coicis Semen. Methods After microwave digestion, the samples were analyzed by inductively coupled plasma mass spectrometry (ICP-MS) and the risk of Pb, Cd, As, Hg and Cu was assessed. Results The linearity of each element was good. The precision was less than 3.0% and the recovery ranged from 81.2% to 112.0%. The contents of K, Mg, Ca, Fe, Zn, Mn, Al and Na in Coicis Semen by stir-frying with bran were higher (>50 mg·kg-1), while those of Cu, B, Li, Ni, Ba, Sr, Mo, Cr and Ti were lower (1~5 mg·kg-1). V, Se, Co, As, Pb, Be, Cd, Ag, Tl, Au, Hg, Sb were trace elements (<1 mg·kg-1). According to the limits of heavy metals and harmful elements in botanical medicines stipulated in the current 2020 edition of Chinese Pharmacopoeia (hereinafter referred to as the Chinese Pharmacopoeia) (Part I), the same amounts of lead, cadmium and cadmium were found in the 15 batches of Coicis Semen by stir-frying with bran. The pass rate of lead, cadmium, arsenic, mercury and copper in the 15 batches of Coicis Semen by stir-frying with bran was 100%. Risk assessment showed that the hazard indices (HI) of Pb, Cd, As, Hg and Cu in the 15 batches of Coicis Semen by stir-frying with bran were less than 1, indicating that the risk was acceptable. Conclusion The multi-element analytical method developed in this study has a high sensitivity and good specificity, which, combined with risk assessment techniques, can provide a reference for quality control of Coicis Semen by stir-frying with bran.

Key words: Coicis semen by stir-frying with bran, elements, inductively coupled plasma mass spectrometry (ICP-MS), determination, risk assessment

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