The Toxicological Assessment of Content and Exposure of Heavy Metals (Pb and Cd) in Traditional Herbal Medicinal Products with Marshmallow Root (Althaea officinalis L., radix) from Polish Pharmacies

Abstract

The level of potentially toxic elements (PTE) in phytopharmaceuticals can be a potential threat to human health through the food chain. The traditional herbal medicinal products (THMPs) with the marshmallow root (Althaea officinalis L., radix), which we can find in European pharmacies, are widely used among the European population. However, recently, voices have been heard in the public about alleged PTE occurrence. In this article, the levels of Pb and Cd impurities were measured in samples of THMPs with marshmallow root available in Polish pharmacies (n = 10). Our proposed toxicological approach was based on two important issues. The first was PTE levels (Pb: 1.60–6.80 μg/L and Cd: 0.80–3.81 μg/L presented as raw results) in comparison with the permissible limit set by FAO/WHO for medicinal herbs (10,000 µg/kg for Pb and 300 µg/kg for Cd) and also ICH Q3D guidelines (0.5 μg/g for Pb and also Cd). The second was the estimation of exposure of investigated PTE in a single dose and daily dose for each THMP. It should be noted that the content of analyzed heavy metals in a single dose of analyzed products was very low, and hence is not a threat for patients. The obtained daily intake of heavy metals impurities in comparison with PDE values confirms the safety of all analyzed phytopharmaceuticals (all of the samples meet the standards of the ICH Q3D guideline). It can be summarized that each of the analyzed THMP with marshmallow root available in Poland are safe for the patients. Based on literature review, this article is the first study about heavy metals impurities level in final THMPs with A. officinalis L., radix (marshmallow root) available in European pharmacies.

Concentrations and Health Risk Assessment of Potentially Toxic Elements in Medicinal Herbs from Northern Nigeria

“…Potentially toxic elements pollution of herbs has been earlier reported in numerous studies [1]. The potentially toxic element contamination in herbs could be due to the contaminated environment in which the plants are raised [9][10][11]. The contaminated environment in which the plants are dried up, processed, and their storage or even adulterated tenaciously by the producer of the products in the finishing dosage [12].…”

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

“…However, for cadmium, several oral exposure studies of cadmium in animal studies (rats and mice) showed no evidence of carcinogenicity [ 1 ]. Hence, the key point for HHRA by oral route is renal toxicity of Cd [ 24 ], and minimal risk level (MRL) as 0.1 µg/kg bw/day [ 19 ] should be applied as POD sys . 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.…”

“…The estimated daily exposure levels for Cd impurities are similar. As was mentioned earlier, the main point for toxicological assessment of Cd by oral route is renal toxicity [ 19 ] and the oral PDE value (5.0 µg/day [ 1 ]). Our results ( Table 5 ) indicate that all analyzed HMP are characterized by results extremely lower than PDE value for Cd.…”

“…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. …”

The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity

“…A review of the current literature shows that it is a very rare topic [4,5]. Studies including EI in herbal medicinal products available in pharmacies are dynamically developed by the group conducted by Jurowski et al [6][7][8][9]. Based on the literature review, elements that are characterized by the phenomenon of speciation are a major challenge.…”