Human Health Risk Assessment of Heavy Metals and Metalloids in Herbal Medicines Used to Treat Anxiety: Monitoring of Safety

Abstract

The present study estimated the human health risk assessment and daily intake of heavy metals and metalloids in herbal medicines used to treat anxiety in Brazil. Six different brands of herbal medicines were purchased in the city of Campo Grande/MS, Brazil: Pasalix®, Calman®, Serenus®, Maracugina®, Prakalmar® and Calmasyn®. In total, eight elements including As, Ba, Cd, Co, Cr, Cu, Fe, and Pb were analyzed using optical emission spectrometry with inductively coupled plasma (ICP OES). Only the concentration of As in the herbal medicine Prakalmar® is above the values established by United States Pharmacopoeia Convention (USP) and Brazilian Pharmacopoeia (BF) for permitted concentration of elemental impurities in drugs substances. The concentration of Ba, Cd, Co, Cr and Cu in all herbal medicines are lower than the values set by USP and FB. The concentration of Pb in Calman® is lower than the limits established by BF, but higher than those established by USP. Pasalix, Serenus®, Calmasyn®, Prakalmar® and Marcacugina® have a higher Pb concentration than the values allowed by USP and BF. All herbal medications have concentrations within safe ranges for human consumption, with the exception of Calmasyn®, which has Pb over the value defined by USP for oral permissible daily exposure (PDE) for elemental impurities. The values of estimated daily intake (EDI) of metal (loid)s in adults and children obtained from the consumption of the herbal medicines are below the values stipulated by the minimal risk levels (MRLs). All the hazard index (HI) values recorded in this study were below 1. However, monitoring by regulatory agency is necessary, large doses of heavy metal may cause acute or chronic toxicities.

Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry

“…Due to the potential of elemental impurities to lower the shelf life of active pharmaceutical ingredients by catalyzing their disintegration or their inherent toxicity(e.g.neurotoxicity, nephrotoxicity, carcinogenicity, immunotoxicity, etc. ), they may pose a threat to human health 7,8 . Drug authorities around the world require the pharmaceutical industry to monitor and control toxic elements to acceptable levels.…”

Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry

“…The reason behind this concern lies in the inherent toxicity of these impurities and their ability to catalyze the decomposition of APIs, ultimately presenting hazards to human health. 3,4 A new paradigm for the control and risk assessment of EIs in pharmaceuticals has been established with the publication of the Guideline for Elemental Impurities (Q3D) by the International Council for Harmonization (ICH). The guideline sets permitted daily exposure (PDE) in μg/day for 24 elements from three routes of administration (oral, parenteral, and inhalation).…”