Heavy metals contamination in two species of medicinal plants in the Iranian market

Shahkarami, Sanaz; Goudarzi, Fazel; Amiri‐Ardekani, Ehsan; Dehghani, Samaneh

doi:10.1080/03067319.2021.1990903

Cited by 7 publications

(6 citation statements)

References 40 publications

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“…On the other hand, considering for Pb the integrated exposure uptake biokinetic (IEUBK) model [ 20 , 25 ] based on the assumption of 100% absorption, the oral intake of lead is 5.0 μg/day. Additionally, dietary Pb exposure was found to be about one-third lower than previously estimated with mean levels for the four older age groups not exceeding the BMDL 01 and BMDL 10 of 1.50 and 0.63 μg/kg bw/day established for cardiovascular and nephrotoxicity effects in adults [ 21 ]. Hence, BMDL 10 (0.63 μg/kg bw/day) should be applied as POD sys .…”

Section: Resultsmentioning

confidence: 99%

“…Based on the literature review, it should be stated that no studies on the content of cadmium impurities in this type of pharmaceuticals products or similar matrices have been published so far. There are only indications as to the raw materials showing the presence of Cd [ 21 , 22 ], which was the justification for conducting this type of research. Therefore, it is not possible to reliably compare the obtained results with other studies.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, it is not possible to reliably compare the obtained results with other studies. However, all HMP with Mentha × piperita L., folium contained levels of Cd impurities below the permissible limit set by FAO/WHO for medicinal herbs and plants in different countries (WHO recommendation, 0.3 mg/kg) [ 21 , 26 ]. Additionally, based on permitted levels for Cd in final pharmaceutical products (oral route of exposure) recommended by ICH Q3D R1 guideline (0.5 μg/g [ 1 ]), all investigated HMP met the requirements.…”

Section: Discussionmentioning

confidence: 99%

“…Hence, the aim of our study is not determination of chosen heavy metals (Cd and Pb) but the comprehensive HHRA of these impurities in HMP as Menthae piperitae tinctura ( Mentha × piperita L., folium) available in Polish pharmacies. The justifications for choosing these two metals were: The fact that Cd and Pb impurities in final pharmaceuticals are most important from toxicological point of view (first class of elemental impurities in ICH Q3D R1 guideline [ 1 ]); Our analytical possibilities and scientific experiences [ 18 , 19 , 20 ]; The possibility of this kind of contamination in the raw plant materials used for the production of these HMP based on literature review [ 21 , 22 ]; The rarity of this type of research in the field of comprehensive HHRA of elemental impurities in final pharmaceutical products; The need to fill a gap in the scientific literature regarding the control of these elemental impurities in phytopharmaceutical product. …”

Section: Introductionmentioning

confidence: 99%

“…The possibility of this kind of contamination in the raw plant materials used for the production of these HMP based on literature review [ 21 , 22 ];…”

Section: Introductionmentioning

confidence: 99%

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The Human Health Risk Assessment of Heavy Metals Impurities (Cd and Pb) in Herbal Medicinal Products as Menthae piperitae tinctura (Mentha × piperita L., folium) Available in Pharmacies from Poland

Jurowski

Krośniak

2022

Toxics

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Appropriate human health risk assessment (HHRA) is desire in modern regulatory toxicology, especially for elemental impurity studies. The aim of this article is the comprehensive HHRA of two heavy metals impurities—Cd and Pb in herbal medicinal products (HMP) as Menthae piperitae tinctura (Mentha × piperita L., folium) available in Polish pharmacies. These phytopharmaceuticals registered in EU are very common and usually applied OTC products by adults and also children/adolescents. For this purpose, we applied double regulatory approach, including: (1) requirements of ICH Q3D R1 guideline about elemental impurities and (2) additionally margin of exposure (MoE)-based concept to cover also specific population groups. Raw results shows that Cd and Pb were present in all analyzed HMP with Mentha × piperita L., folium (PTM1–PTM10) available in Polish pharmacies. In all samples, Cd impurities (in the range: 0.305–0.506 µg/L) were greatly lower than Pb impurities (in the range: 1.122–4.4921 µg/L). The HHRA of Cd and Pb impurities considering ICH Q3D R1 guideline-based approach made it possible to conclude that all results were below the permissible limit set by FAO/WHO for medicinal herbs and plants in different countries (300 µg/kg for Cd and 10,000 µg/kg for Pb). Additionally, the estimated daily intake of investigated elemental impurities compared to the PDE value confirm all samples safety. The second approach, an MoE-based strategy, indicated that the obtained values of MoE for Cd and Pb in daily dose for each samples were above 10,000; hence, exposure to these elemental impurities would not cause a health risk for all investigated population groups (children, adolescents, and adults). To the best our knowledge, this article is the first study about heavy metals impurities level in final HMPs as Menthae piperitae tinctura (Mentha × piperita L., folium) available in Polish pharmacies.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…The possibility of this kind of contamination in the raw plant materials used for the production of these HMP based on literature review [ 21 , 22 ];…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

The Human Health Risk Assessment of Heavy Metals Impurities (Cd and Pb) in Herbal Medicinal Products as Menthae piperitae tinctura (Mentha × piperita L., folium) Available in Pharmacies from Poland

Jurowski

Krośniak

2022

Toxics

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Bread Consumption-Induced Heavy Metal Exposures and Health Risk Assessment of Pregnant Women: Turkey

Köse

Pekmezci

Başaran

2023

Biol Trace Elem Res

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Heavy metal contamination in medicinal plants: assessing carcinogenic and non-carcinogenic health risks

Sulaiman,

Adamu,

Ali

et al. 2024

Discov Environ

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Medicinal plants have played an undeniable role in treating diseases in mankind. However, these plants may be contaminated by toxic substances like heavy metals. Therefore, this study aimed to determine the contamination and health risks (carcinogenic and non-carcinogenic) of heavy metals in economically important medicinal plants mostly in Northern Nigeria. A total of 72 samples from 12 medical plants were purchased and analyzed for heavy metal (Pb, Cr, As, Cd, Zn, Cu, Ni and Fe) contamination using Atomic Absorption Spectrometry (AAS) after wet digestion. The concentrations of the heavy metals (mg·kg−1) were in the range of 1.71–9.01 for Pb, 0.23–2.08 for Cr, 0.00–0.05 for As, 0.00–0.51 for Cd, 5.08–23.67 for Zn, 1.28–13.45 for Cu, 0.96–1.95 for Ni and 20.58–108.50 for Fe. The results revealed that the plant under study contained unsafe levels of Cr and Cd being higher than the World Health Organization (WHO) permissible limits. The hazard index (HI) was < 1, suggesting a probable non-carcinogenic effect. Similarly, the cancer risk (CR) for children and adults was below the (1.0 × 10–4) acceptable limit, indicating non-probable cancer development for consumers. Based on the studied results, the samples may not pose a carcinogenic health risk. However, there is a need for the regulatory agency to continuously monitor medicine plants available in the markets for the safety of consumers.

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Heavy metals contamination in two species of medicinal plants in the Iranian market

Cited by 7 publications

References 40 publications

The Human Health Risk Assessment of Heavy Metals Impurities (Cd and Pb) in Herbal Medicinal Products as Menthae piperitae tinctura (Mentha × piperita L., folium) Available in Pharmacies from Poland

The Human Health Risk Assessment of Heavy Metals Impurities (Cd and Pb) in Herbal Medicinal Products as Menthae piperitae tinctura (Mentha × piperita L., folium) Available in Pharmacies from Poland

Bread Consumption-Induced Heavy Metal Exposures and Health Risk Assessment of Pregnant Women: Turkey

Heavy metal contamination in medicinal plants: assessing carcinogenic and non-carcinogenic health risks

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