The Toxicological Risk Assessment of Lead and Cadmium in Valeriana officinalis L., radix (Valerian root) as Herbal Medicinal Product for the Relief of Mild Nervous Tension and Sleep Disorders Available in Polish Pharmacies

Kamil Jurowski,Mehmet Berkoz,Barbara Tatar,Maria Fołta,Mirosław Krośniak

doi:10.1007/s12011-021-02691-5

Kamil Jurowski, Mehmet Berkoz + Show 3 more

Open Access

https://doi.org/10.1007/s12011-021-02691-5

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Abstract

Studies related to the toxicological risk assessment (TRA) of heavy metal impurities (HMIs) in pharmaceuticals are an important issue but there is a lack of refereed literature around the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product (HMP) for the relief of mild nervous tension and sleep disorders according to lead and cadmium impurities. The aim of the study was to estimate the TRA of lead and cadmium in Valeriana officinalis L., radix (Valerian root) as HMP (n = 5) available in Polish pharmacies. In the case of herbal pharmaceuticals, it is particularly important to control the level of HMIs accumulated during the plant’s growth. Perhaps, the exposure for a single dose is not relevant; however, justification of our studies is a fact that herbal therapies are usually long term. Therefore, even small HMI doses as present in particular plant may accumulate in patient body over a long period of time. Levels of lead and cadmium were measured by electrothermal atomization atomic absorption spectrometry. The levels of lead and cadmium as HMIs (independently of the producer and declared composition) are quite similar. Our results are satisfactory, confirming the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product for the relief of mild nervous tension and sleep disorders available in Polish pharmacies according to ICH guideline Q3D. To the best of our knowledge, this paper is the first study about lead and cadmium content as HMIs in HMP containing Valeriana officinalis L., radix (Valerian root).

Highlights

Herbal medicinal product (HMP) can be defined as “any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations” [1]
The choice of HMP was justified by: 1) availability in Polish pharmacies as representative example of European country due to this herb (Valerian root is one of the major herbs processed by the pharmaceutical industry, with a total annual harvest exceeding 1000 tones in Poland [10]); The toxicological risk assessment (TRA) of metal contamination is always based on toxicological analysis of each element in analyzed samples
Lead and cadmium were present in all analyzed HMP on very low level; lead levels were approximately eight times higher than cadmium levels

Summary

Introduction

Herbal medicinal product (HMP) can be defined as “any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations” [1]. Based on number of traditional use registrations per year for HMP in. From this point of view, very intriguing plant applied in pharmaceutical industry as monocomponent HMP is Valeriana officinalis L. The evidence that valerian root extracts are sedative in people has been equivocal for many decades. This HMP have been shown in human to improve sleep quality [4], to reduce latency to fall asleep [5], and to diminish feelings of somatic arousal during a social stress situation [6, 7]. V. officinalis L. extract was found to contain material binding to the central benzodiazepine receptor being without other benzodiazepine-like properties [8]

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