中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 645-648.
DOI: 10.19803/j.1672-8629.2021.07.11

• 法规与管理研究 • 上一篇    下一篇

中药中农药残留风险评估指导原则的形成及其研究思路

王莹1, 张磊2, 左甜甜1, 申明睿3, 金红宇1#, 马双成1,*   

  1. 1中国食品药品检定研究院,北京 102629;
    2国家食品安全风险评估中心,北京 100021;
    3国家药典委员会,北京 100061
  • 收稿日期:2021-02-26 出版日期:2021-07-15 发布日期:2021-07-23
  • 通讯作者: *马双成,男,博士,研究员,中药质量与安全研究。E-mail：masc@nifdc.org.cn;# 为共同通信作者。
  • 作者简介:王莹,女,博士,副研究员,中药质量与安全研究。
  • 基金资助:
    重大新药创制国家科技重大专项2018年度（2018ZX09303-024）

Formulation and Research of Guidelines for Risk Assessment of Pesticide Residues in Traditional Chinese Medicine

WANG Ying1, ZHANG Lei2, ZUO Tiantian1, SHEN Mingrui3, JIN Hongyu1#, MA Shuangcheng1,*   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2China National Center for Food Safety Risk Assessment, Beijing 100022, China;
    3Chinese Pharmacopoeia Commission, Beijing 100061, China
  • Received:2021-02-26 Online:2021-07-15 Published:2021-07-23

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摘要： 目的 为中药中农药风险评估研究工作提供思路和借鉴。方法 中药中农药残留风险评估程序包括危害识别、危害特征描述、暴露评估和风险描述4个步骤。本文围绕农药风险评估常用方法、中药中农药残留风险评估方法的研究思路及重要参数的选择进行探讨。结果 中药中农药风险评估在借鉴食品风险评估模式的同时,进一步考虑中药服用特点,逐步建立了符合中药使用特点的农药残留风险评估体系,形成风险评估的指导原则。结论 开展中药中农药残留风险评估工作对于中药中农药残留标准的制定和安全监管有重大的现实意义。

关键词: 风险评估, 中药, 农药残留, 指导原则, 累积评估, 点评估

Abstract: Objective To provide route and reference for the research of pesticide risk assessment in TCM. Methods The risk assessment procedure of pesticide residues in TCM includes four steps: hazard identification, hazard characterization, exposure assessment and risk description. The common methods of pesticide risk assessment were summarized, and the research route and the selection of important parameters of pesticide risk assessment methods in TCM were discussed in this paper. Results The risk assessment system of pesticide residues in accordance with the use characteristics of TCM was gradually established, and the guiding principles of risk assessment were formed. Conclusion The risk assessment of pesticide residues in traditional Chinese medicine (TCM) is of great significance for the formulation of pesticide residue standards and safety supervision.

Key words: risk assessment, traditional Chinese medicine, pesticide residues, guidelines, cumulative assessment, deterministic approach

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