The Toxicological Risk Assessment of Cu, Mn, and Zn as Essential Elemental Impurities in Herbal Medicinal Products with Valerian Root (Valeriana officinalis L., radix) Available in Polish Pharmacies

Abstract

The toxicological risk assessment (TRA) of elemental impurities (EI) in especially herbal medicinal products (HMP) is a significant challenge for pharmaceutical industry. In Europe, very popular are traditional HMP with valerian root (Valeriana officinalis L., radix) for relief of mild symptoms of mental stress and to aid sleep. The aim of our unique article is the comprehensive TRA of Cu, Mn, and Zn as EI in HMP with V. officinalis L., radix available in Polish pharmacies. This article is a continuation of our previously conducted studies about TRA of heavy metals (Pb and Cd) in these same samples. Investigated elements were determined by flame atomic absorption spectrometry (F AAS). The values of the correlation coefficients (R > 0.998) confirm the linearity of the applied instrument for precision and accuracy of results. The recoveries, LOD and LOQ values were acceptable. Our results show that all investigated HMP with valerian root available in Polish pharmacies contain Cu (0.16–0.23 mg/L), Mn (0.11–0.76 mg/L), and Zn (0.22–0.48 mg/L) at a very low level. Based on our estimation of EI including single dose (µg/20 mL) and estimated daily intake (µg/day), our results confirm the safety of all pharmaceuticals. To the best of our knowledge, the Cu, Mn, and Zn impurity profile in HMP with V. officinalis L., radix is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view (ICH Q3D elemental impurities guideline for pharmaceuticals).

The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Nickel and Chromium due to Application of Ointments with Marjoram Herb Extract (Majoranae Herbae Extractum) Available in Polish Pharmacies

“…For this reason, a monitoring nickel content in herbal-based pharmaceuticals available in European Union will be desirable. Moreover, herbal medicinal products should be monitored for the presence of other important and potentially hazardous EIs [16][17][18]. Finally, our results are important and may be significant for other scientist and regulatory affairs working in pharmaceutical industry, especially due to PDE-related topics.…”

The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

“…It should be underlined that the monitoring of elemental impurities in herbal medicinal products is an extremely rare topic; hence, it would be valuable to carry out a broader study including other elemental impurities to build upon this data like the studies recently described by our group [21][22][23][24][25].…”

Health Risk Assessment of Toxic Metals Consumed Through Plant-Based Anti-Diabetic Therapeutics Collected in the Northern Divisional City of Rajshahi, Bangladesh

“…Studies conducted earlier in different countries revealed that herbal preparations contain heavy metals beyond the World Health Organization's (WHO) maximum permissible limit. The studies included but were not limited to the following lead investigators: Haris and Yang in China [13,14], Jurowski in Poland [15,16], Bas gel in Turkey [17], Saper in the United States of America [18], Garvey [19] etc. This may place drug safety at risk and affect public health negatively.…”

“…Unsafe samples follow the trend: Hg > Ni > Zn > Mn > Cd > Cu > Pb > Cr > As. Metals exceeding safety limits in samples in varying degrees were documented in Asian[13,14,17], European[15, 16], and American [18] investigations. Metal ions cause toxicity by interacting with cellular structural proteins, enzymes, and membrane systems…”