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植物制品中的元素杂质(重金属):已发表的个别产品分析评估。

Elemental impurities (heavy metals) in kratom products: an assessment of published individual product analyses.

机构信息

Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, CT, USA.

Department of Pharmacy and Research Administration, Hartford Hospital, Hartford, CT, USA.

出版信息

Clin Toxicol (Phila). 2024 Oct;62(10):651-660. doi: 10.1080/15563650.2024.2395552. Epub 2024 Sep 5.

Abstract

INTRODUCTION

Kratom is commonly used by consumers, and the elemental impurity exposure that consumers would have at different kratom ingestion doses has been determined.

METHODS

This assessment used original data from independent third-party laboratory testing of kratom products to identify the percentage of products that exceeded permissible daily exposure limits for lead (5 µg/day), nickel (200 µg/day), arsenic (15 µg/day), and cadmium (5 µg/day), the interim reference level for lead in adults (12.5 µg/day), and the tolerable upper intake level for manganese (11 mg/day) and nickel (1 mg/day). We assessed all products regardless of type and then evaluated non-extract products, extract products, and a soda preparation separately for elemental impurities.

RESULTS

Three assessments of elemental impurities in kratom products have been published, totaling 68 products. Assessing all products and assuming a 3 g daily dose of kratom, 7.4% would exceed the permissible daily exposure limits for lead, 0% for nickel, 3.1% for arsenic, and 0% for cadmium. At a kratom dose of 25 g daily, 70.6% would exceed the permissible daily exposure limits for lead, 20.6% for nickel, 9.4% for arsenic, and 0% for cadmium. The interim reference level for lead would be exceeded by 1.5% of products at a kratom daily dose of 3 g and 33.8% of products at 25 g. The tolerable upper intake level for manganese would be exceeded by 12.5% of products at a kratom daily dose of 3 g and 41.7% of products at 25 g. Non-extract products generally contain greater concentrations of elemental impurities than extract products or the soda preparation.

DISCUSSION

Apart from their concentrations in a gram of product, assessing the amount of exposure to elemental impurities at different kratom ingestion doses is also important. Elemental impurities exceeding regulatory permissible concentrations for many products, especially with greater daily kratom ingestion doses, may impact human health.

CONCLUSIONS

Some kratom products contain excessive concentrations of elemental impurities of toxicological concern, such as lead and arsenic. Non-extract products (powders, capsules, tablets) generally contain greater concentrations of elemental impurities than extract products or the soda preparation. Daily use of these products can result in exposures exceeding regulatory thresholds and adverse health effects.

摘要

简介

消费者经常使用咔哇潮饮,本研究测定了不同咔哇潮饮摄入量下消费者可能会接触的元素杂质。

方法

本评估使用了独立第三方咔哇潮饮产品检测的原始数据,以确定超过铅(5μg/天)、镍(200μg/天)、砷(15μg/天)和镉(5μg/天)每日允许摄入量、成人铅暂定参考水平(12.5μg/天)以及锰(11mg/天)和镍(1mg/天)可耐受最高摄入量的产品所占的百分比。我们评估了所有产品,然后分别评估了非提取物产品、提取物产品和苏打水制剂的元素杂质。

结果

已发表了 3 项咔哇潮饮产品元素杂质评估,共涉及 68 种产品。评估所有产品并假设咔哇潮饮的日剂量为 3g,7.4%的产品会超过铅的每日允许摄入量,0%的产品会超过镍,3.1%的产品会超过砷,0%的产品会超过镉。当咔哇潮饮的日剂量为 25g 时,70.6%的产品会超过铅的每日允许摄入量,20.6%的产品会超过镍,9.4%的产品会超过砷,0%的产品会超过镉。当咔哇潮饮的日剂量为 3g 时,1.5%的产品会超过铅暂定参考水平,当剂量为 25g 时,33.8%的产品会超过该水平。当咔哇潮饮的日剂量为 3g 时,12.5%的产品会超过锰的可耐受最高摄入量,当剂量为 25g 时,41.7%的产品会超过该水平。非提取物产品通常比提取物产品或苏打水制剂含有更高浓度的元素杂质。

讨论

除了产品中每克的浓度外,评估不同咔哇潮饮摄入量下元素杂质的暴露量也很重要。许多产品的元素杂质浓度超过监管允许浓度,尤其是在每日摄入更大剂量的咔哇潮饮时,可能会影响人类健康。

结论

一些咔哇潮饮产品含有毒理学关注的元素杂质,如铅和砷,浓度过高。非提取物产品(粉末、胶囊、片剂)通常比提取物产品或苏打水制剂含有更高浓度的元素杂质。这些产品的日常使用可能会导致暴露量超过监管阈值和产生不良健康影响。

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