Rhinitis, rhinosinusutus and phytotherapy

Acute rhinitis and acute rhinosinusitis (ARS) have viral etiology in the most of cases, and their therapy is aimed at alleviating clinical symptoms and preventing new episodes. The indications for antibiotic therapy are severe bacterial ARS, ARS with complications, and recurrent bacterial ARS. Such a categorical approach is due to the increase of antibiotic resistance, which leads to the popularization of efficient phytotherapy. Modern herbal medical products comply with general recommendation and standards of efficacy, safety and quality, and their effectiveness has been proven in clinical trials along with synthetic drugs. In acute upper respiratory tract infections, herbal medical drugs stimulate the immune system, relieve clinical symptoms, and improve the patient’s quality of life. A significant emphasis in phytotherapy is given to complex drugs synthesized on the basis of phytoneering. One of such remedies is the herbal medicinal product containing the different parts of 5 medicinal herbs: Gentian root (Gentianae radix), Primrose flowers (with calyx) (Primulae flos (cum calycibus)), Common sorrel herb (Rumicis herba), Elder flowers (Sambuci flos) and Vervain herb (Verbenae herba). This herbal medicinal product shows secretolytic, secretomotor, antiinflammatory, antiviral and mild antibacterial farmacological effects. The article provides an analysis of studies in vitro and in vivo proving the anti-inflammatory effect of Sinupret®, its potentiating effect on nasal mucosa mucociliary transport as well as efficacy and safety in patients with rhinosinusitis.

Sedative Effect and Standardization Parameters of Herbal Medicinal Product Obtained from the Ocimum americanum L. Herb

Sedative phytomedications continue to play an important role in the management of a considerable amount of anxiety symptoms because of the various side effects of synthetic sedatives and tranquilizers. However, developing new herbal drugs needs their appropriate quality control according to the relevant requirements. The aim of the study was to determine the sedative properties of the tinctures obtained from the American basil (Ocimum americanum L., Lamiaceae Martinov family) herb and to develop the standardization parameters for the promising herbal medicinal product. The open field test was used to evaluate the sedative effect of the prepared tinctures: (1) with the added of O. americanum essential oil (OATEs) and (2) without adding O. americanum essential oil (OAT). The standardization parameters for the OATEs were developed using validated High-Performance Thin Layer Chromatography (HPTLC) and High-Performance Liquid Chromatography (HPLC) methods. The HPTLC analysis was used for the chromatographic fingerprints of polyphenols and for identifying linalool in the OATEs. The HPLC analysis found the significant content of rosmarinic acid (RA) (0.26%) in the OATEs. In conclusion, the developed OATEs can be considered as the new herbal medicinal product with significant sedative properties.

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

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).

Improvement of Methods of Standardisation of Medicinal Products Made from Veratrum Lobelianum Rhizomes with Roots

Identification of hellebore (Veratrum Lobelianum Bernh.) herbal substance, as well as hellebore-based herbal preparation and herbal medicinal product by the same group of biologically active substances using the same test method is in line with the so-called “consistent standardisation” principle.The aim of the study was to develop a harmonised approach to identification of steroidal alkaloids in hellebore products (hellebore water, hellebore tincture) and hellebore herbal substance (hellebore rhizomes with roots).Materials and methods: samples of hellebore water, hellebore tincture, and hellebore rhizomes with roots were analysed by high-performance thin-layer chromatography (HPTLC) using an HPTLC plate.Results: the authors developed a harmonised identification procedure for products made from hellebore rhizomes with roots (herbal substance, herbal preparation, and herbal medicinal product) based on HPTLC detection of steroidal alkaloids. The results of the study will be used to prepare amendments to the Identification part of monograph FS.2.5.0104.18 “Hellebore rhizomes with roots”. The developed test procedure is proposed for inclusion into draft monographs “Hellebore rhizomes with roots, tincture” and “Hellebore rhizomes with roots, tincture, solution for external use”.Conclusions: the developed test procedure can be used as an identification test for a range of products from the hellebore herbal substance to hellebore-based herbal medicinal products, which is based on the detection of the same group of biologically active substances.