中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 379-382.
DOI: 10.19803/j.1672-8629.20210658

• 基础与临床研究 • 上一篇    下一篇

板蓝根中外源性有害残留的全面检查及风险评估

聂黎行1, 陈佳1Δ, 张烨2, 赵慧1#, 戴忠1, 马双成1,*   

  1. 1中国食品药品检定研究院,北京 100050;
    2鄂尔多斯市检验检测中心,内蒙古 鄂尔多斯 017010
  • 收稿日期:2021-07-08 出版日期:2023-04-15 发布日期:2023-04-20
  • 通讯作者: *马双成,男,博士,研究员·博导,中药民族药物质基础与质量安全评价。E-mail：masc@nifdc.org.cn;#为共同通信作者。
  • 作者简介:聂黎行,女,博士,研究员,中药分析。Δ为并列第一作者。
  • 基金资助:
    国家科技重大专项重大新药创制（2018ZX09735006）; 国家自然科学基金资助项目（81303194）

Comprehensive tests and risk assessment of exogenous harmful residues in Isatidis Radix

NIE Lixing1, CHEN Jia1Δ, ZHANG Ye2, ZHAO Hui1#, DAI Zhong1, MA Shuangcheng1,*   

  1. 1National Institutes for Food and Drug Control, Beijing 100050, China;
    2Ordos Inspection and Testing Center, Ordos Inner Mongolia 017010, China
  • Received:2021-07-08 Online:2023-04-15 Published:2023-04-20

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摘要： 目的 对板蓝根中外源性有害残留进行全面检查和风险评估,为板蓝根的安全用药提供参考。方法 采用气相色谱-三重四极杆质谱联用仪和液相色谱-三重四极杆质谱联用仪测定33种禁用农药,免疫亲和柱-高效液相色谱-柱后光化学衍生法测定4种黄曲霉毒素,电感耦合等离子体质谱测定5种重金属及有害元素,离子色谱法测定二氧化硫,并采用靶标危害系数法对安全风险做出评估。结果 64批样品中33种禁用农药和黄曲霉毒素B1、B2、G1、G2均未检出。二氧化硫低于《中华人民共和国药典》（2020年版）规定限度（150 mg·kg-1）,64批样品及板蓝根品种中二氧化硫和Pb、Cd、As、Hg、Cu的靶标危害系数均远低于1。基于风险评估结果提出板蓝根中Pb、Cd、As、Hg、Cu的限度分别为2、1、2、0.2、20 mg·kg-1。结论 板蓝根中外源性有害残留风险低。

关键词: 板蓝根, 有害残留, 农药残留, 重金属, 黄曲霉毒素, 二氧化硫, 风险评估

Abstract: Objective To conduct a comprehensive inspection and risk assessment of exogenous harmful residues in Isatidis Radix so as to provide reference for safe use of Isatidis Radix. Methods Thirty-three forbidden pesticides were determined using gas chromatography-tandem mass spectrometry (GC-MS-MS) and high performance liquid chromatography-tandem mass spectrometry (HPLC-MS-MS) methods. Four aflatoxins were determined with the high performance liquid chromatography with fluorescence detection after immunoaffinity column clean-up (IC-HPLC-FD) method. Five heavy metals and harmful elements were determined via inductively coupled plasma mass spectrometry (ICP-MS). Sulfur dioxide was determined by means of ion-chromatography (IC). Subsequently, risk assessment was performed using the target hazard quotient (THQ) method. Results Thirty-three forbidden pesticides or aflatoxin B1, B2, G1 and G2 were not detected in 64 batches of Isatidis Radix. Contents of sulfur dioxide were all below the limit specified by the Chinese Pharmacopeia (150 mg·kg-1). THQ of sulfur dioxide, Pb, Cd, As, Hg and Cu in 64 samples and Isatidis Radix were far below one. Based on risk assessment, limits of Pb, Cd, As, Hg and Cu in Isatidis Radix were proposed as 2, 1, 2, 0.2 and 20 mg·kg-1, respectively. Conclusion The risk of exogenous harmful residues in Isatidis Radix is low.

Key words: Isatidis Radix, harmful residues, pesticides, heavy metals, aflatoxins, sulfur dioxide, risk assessment

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