Findings on the heavy metal content in herbal drugs and essential oils – An updated database evaluation

IF 3.8 2区农林科学 Q1 PLANT SCIENCES

Journal of Applied Research on Medicinal and Aromatic Plants Pub Date : 2024-11-22 DOI:10.1016/j.jarmap.2024.100609

Gerald Binder , Matthias Knödler , Bernhard Klier , Patricia Zang , Hagen Albert , Alexandra Barofsky , Barbara Steinhoff

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Abstract

In order to guarantee the safety of patients and consumers, the European legal framework restricts the content of heavy metals and further elements in plant material used for the production of medicinal and food products. This data evaluation comprises findings on seven elements between 2016 and 2021 which were assessed against the requirements of the European Pharmacopoeia (Ph.Eur.) and the ICH Q3D guideline on elemental impurities. !5.328 herbal drug samples from 427 products and 537 essential oil samples from 25 products were included in this evaluation which demonstrates that the Ph. Eur. limits set for cadmium, lead and mercury are considered appropriate. Samples from organic production revealed a lower occurrence of cadmium, lead and mercury as compared to samples from conventional production. With regard to the ICH Q3D requirements, none of the herbal drug samples exceeded the respective limit for cobalt, nickel and vanadium, while for arsenic higher values were observed in individual cases. A comparison of the findings with a former period of evaluation showed an increase in positive findings and also a few more exceedances of the Ph.Eur. limits. For essential oils, it can be confirmed that independent from the production process, the probability of heavy metal contamination is low.

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为了保证患者和消费者的安全，欧洲法律框架限制了用于生产医药和食品的植物材料中的重金属和其他元素含量。本数据评估包括 2016 年至 2021 年期间对七种元素的检测结果，并根据《欧洲药典》（Ph.Eur.）和 ICH Q3D 元素杂质指南的要求进行了评估。来自 427 个产品的 5.328 个草药样品和来自 25 个产品的 537 个精油样品被纳入评估范围，这表明《欧洲药典》对镉、铅和汞的限制是适当的。与传统生产的样品相比，有机生产的样品中镉、铅和汞的含量较低。根据 ICH Q3D 的要求，所有中草药样品中的钴、镍和钒都没有超过相应的限值，而砷的限值在个别情况下较高。与前一阶段的评估结果相比，阳性结果有所增加，同时也发现了一些超出欧洲药典限值的情况。对于精油来说，可以确认的是，与生产过程无关，重金属污染的可能性很低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Applied Research on Medicinal and Aromatic Plants Pharmacology, Toxicology and Pharmaceutics-Drug Discovery

CiteScore

6.40

自引率

7.70%

发文量

审稿时长

41 days

期刊介绍： JARMAP is a peer reviewed and multidisciplinary communication platform, covering all aspects of the raw material supply chain of medicinal and aromatic plants. JARMAP aims to improve production of tailor made commodities by addressing the various requirements of manufacturers of herbal medicines, herbal teas, seasoning herbs, food and feed supplements and cosmetics. JARMAP covers research on genetic resources, breeding, wild-collection, domestication, propagation, cultivation, phytopathology and plant protection, mechanization, conservation, processing, quality assurance, analytics and economics. JARMAP publishes reviews, original research articles and short communications related to research.