Traditional Herbal Medicinal Products Research Articles

Beneficial Effects of Castanea sativa Wood Extract on the Human Body and Possible Food and Pharmaceutical Applications.

The aim of this review was to investigate the potential use of Castanea sativa wood extract as a food supplement and to evaluate its beneficial properties for human health. The results of the limited amount of studies suggest promising properties, including potential anti-inflammatory effects. The literature indicates that the extract, which is rich in bioactive compounds such as tannins, offers promising therapeutic possibilities for the treatment of conditions associated with chronic inflammation. Consequently, interest in its use in food and pharmaceuticals is growing. Phytochemical studies have reported antioxidant and antimicrobial activities, and anti-inflammatory, anticancer, hypolipidemic, hypoglycemic, and neuroprotective activities. A suitable extraction method and solvent is crucial for the isolation of bioactive compounds, being green extraction technologies outstanding for the industrial recovery of chestnut wood's bioactive compounds. Nevertheless, it is important to emphasize the importance of adhering to regulatory guidelines and obtaining the necessary approvals from regulatory authorities to ensure product safety and compliance. The regulation of herbal medicinal products with proven efficacy and traditional herbal medicinal products is well defined, monitored by authorized bodies, and subject to strict control measures. It is noteworthy that medicinal products are subject to stringent quality testing to ensure safety and efficacy in use, whereas there are no comparable regulatory standards and specific labeling requirements for dietary supplements. When using herbal products, compliance with established standards in health research is essential.

The comprehensive strategy in the human health risk assessment of total chromium impurities in cough syrups with Marshmallow Root (Althaea officinalis) available in Polish pharmacies: regulatory aspects and special emphasis on Cr(VI) mode of action

Chromium, which can currently only be considered pharmacologically active and not an essential element, is a very intriguing elemental impurity in final pharmaceutical products, especially traditional herbal medicinal products. This kind of traditional herbal medicinal product with Marshmallow root (Althaea officinalis L., radix) registered in the EU is widely used among the European population. The aim of this article is to propose a double regulatory strategy in assessing the human health risk of total chromium impurities in cough syrups with Marshmallow Root (Althaea officinalis) available in Polish pharmacies. We applied the strategy based on the requirements of the ICH Q3D (R1) guideline for the assessment of Cr impurities in final traditional herbal medicinal products with Marshmallow Root registered in the EU. Furthermore, we applied the strategy based on the concept of margin of exposure (MoE) considering Cr(VI) genotoxicity mode of action (MOA) and based on BMD10 for Cr(VI) as a point of departure (PoD). The total Cr content was in the range: 1.12–9.61 µg/L (in comparison with the ICH Q3D R1 guidelines: 1100 µg/g). Total Cr levels in a single dose were relatively high compared to raw results, but were not a threat to patients. Comparison of estimated results with oral PDE value for Cr in final drugs suggested by the ICH Q3D R1 guideline (10,700 µg/day) show that all the products analyzed were below this value (the highest result was 278.40 ng/day). Despite conservative assumptions, the MoE values obtained for Cr in daily dose for each Marshmallow Root cough syrup were above 10,000; therefore, exposure to Cr would not cause a health risk for specific population groups (children and adults). It can be summarized that each of the phytopharmaceuticals analysed with Marshmallow root available in Polish pharmacies does not represent a health hazard to patients. We confirm the safety of Cr impurities by applying a double regulatory strategy without the application of an expansive and demanding HPLC-ICP-MS technique for Cr speciation.

A harmonisation approach to traditional Chinese medicine registration in Asian countries

The traditional Chinese medicine (TCM) industry is critical to not only for public health but also for economic growth. According to the European Union (EU) directives, under the EU framework for (traditional) herbal medicinal products, herbal medicines with long history of use can be registered in EU. However, there is a condition in this directive in which only those that have at least 10–15 years in the EU market are accepted for registration and/or marketing authorization. In author opinion, the condition of 10–15 years of use in EU countries set within the EU regulatory framework is with consideration of the genetic differences which can result in variation in adverse drug responses among different world populations. With this concept in mind, it is reasonable to project the principal of the EU directive to the Asian countries where TCM is originated. Countries like China, Singapore, Japan and South Korea that have well established drug registration framework are in best position in executing the best practice and facilitate harmonization of registration for TCM within the region. Furthermore, the registration process itself allows more safety and efficacy data to be collected systemically before and after product registration/marketing authorization. These are valuable information for future drug development. The therapeutic value of TCM is limitless, it has been left out in the EU regulatory framework, and the opportunity for it to be expanded and carried forward in modern medicines is shadowed by the limited number of TCM that are qualified to be registered under the EU regulatory framework. An early establishment of a harmonized risk-based registration process for TCM in Asian countries is important. This will strengthen the database to substantiate the history of safe use and further preserving and expanding the therapeutic values of TCM within and beyond the Asian region.

Content of Bioactive Compounds in Highbush Blueberry Vaccinium corymbosum L. Leaves as a Potential Raw Material for Food Technology or Pharmaceutical Industry.

This study was performed to investigate the content of selected phenolic compounds, antioxidant activity and the levels of arbutin and hydroquinone in 25 varieties of highbush blueberry (Vaccinium corymbosum) leaf samples. An analysis of the bioactive components was performed using the HPLC technique and the antioxidant activity was determined via spectrophotometric methods. The content of chlorogenic acid in the analysed leaf extracts ranged from 52.76 mg/g (Spartan variety) to 32.37 mg/g (Nelson variety) and was present in the highest concentration among all the analysed phenolic acids. Particularly large levels of isoquercetin were found in the Aurora, Ivanhoe and Toro varieties (28.40 mg/g, 26.24 mg/g and 21.57 mg/g, respectively). An exceptionally high rutin content (p < 0.05) was found in the Ivanhoe variety (27.19 mg/g) as compared to the other varieties, where it ranged from 2.06 mg/g (Earliblue and Patriot varieties) to 10.55 mg/g (Bluejay variety). The Patriot variety was determined to possess the highest antioxidative activity using the FRAP method (1086.15 μmol Trolox/g d.w.) and based on its DPPH radical scavenging activity (1124.17 μmol Trolox/g d.w.). The total phenolic content (TPC) determined via spectrophotometry ranged from 48.11 mg GAE/g d.w. (Elizabeth variety) to 177.31 GAE/g d.w. (Patriot variety). The arbutin content in the leaves of all tested varieties exceeded 2%, so it can be concluded that they constitute a stable source of arbutin. Three varieties (Bonus, Chanticleer and Herbert) can be considered a potential alternative to bearberry and lingonberry leaves. The hydroquinone content in the analysed extracts was determined to be at a lower level. V. corymbosum leaves can be considered an interesting herbal material for use in traditional herbal medicinal products but not directly for food products and dietary supplements.

Novel Combination of Choline with Withania somnifera (L.) Dunal, and Bacopa monnieri (L.) Wetts Reduced Oxidative Stress in Microglia Cells, Promoting Neuroprotection.

Memory deficit is one of the major negative outcomes of chronic stress. Cholinergic system modulates memory not only through the neuronal cells, but also via interactions with non-neuronal cells, suggesting that microglia can influence synaptic function and plasticity, contributing to cognition and memory function. Withania somnifera (L.) Dunal (WS) and Bacopa monnieri (L.) Wettst (BM), are traditional herbal medicinal products used for the temporary relief of symptoms of stress. The aim of this study was to investigate whether choline (CLN) activity could be enhanced via an association with adaptogens: WS and BM extracts. First, we optimized an in vitro model of corticotropin-releasing hormone (CRH)-induced oxidative stress on microglial BV2 cells. CRH 100 nM reduced BV2 cell viability and induced morphological changes and neurotoxicity after 24 h of microglia stimulation. Moreover, it induced an increase in the production of reactive oxygen species (ROS) and dysregulated antioxidant protein (i.e., SIRT-1 and NRF-2). The association between choline and adaptogens (CBW) 10 μg/mL counteracted the effect of CRH on BV2 cells and reduced the neurotoxicity produced by BV2 CRH-conditioned medium in the SH-SY5Y cell lines. CBW 200 mg/kg produced an ameliorative effect on recognition memory in the novel object recognition test (NORT) test in mice. In conclusion, combining choline with adaptogen plant extracts might represent a promising intervention in chronic stress associated with memory disturbances through the attenuation of microglia-induced oxidative stress.

Oridonin attenuates the progression of atherosclerosis by inhibiting NLRP3 and activating Nrf2 in apolipoprotein E-deficient mice

Oridonin, a well-known traditional Chinese herbal medicinal product isolated from Isodon rubescens (Hemsl.) H.Hara, has many potential properties, including anti-inflammatory and antioxidant activities. However, there is no evidence whether oridonin have a protective effect on atherosclerosis. This study focused on the effects of oridonin on oxidative stress and inflammation generated from atherosclerosis. The therapeutic effect on atherosclerosis was evaluated by intraperitoneal injection of oridonin in a high-fat fed ApoE−/− mouse model. We isolated mouse peritoneal macrophages and detected the effect of oridonin on oxidized low-density lipoprotein-induced lipid deposition. Oil red O staining, Masson's staining, dihydroethidium fluorescence staining, immunohistochemical staining, western blotting analysis, immunofluorescence, enzyme-linked immunosorbent assay and quantitative real-time PCR were used to evaluate the effect on atherosclerosis and explore the mechanisms. Oridonin treatment significantly alleviated the progression of atherosclerosis, reduced macrophage infiltration and stabilized plaques. Oridonin could significantly inhibit inflammation associated with NLRP3 activation. Oridonin significantly reduced oxidative stress by blocking Nrf2 ubiquitination and degradation. We also found that oridonin could prevent the formation of foam cells by increasing lipid efflux protein and reducing lipid uptake protein in macrophages. Oridonin has a protective effect on atherosclerosis in ApoE−/− mice, which may be related to the inhibition of NLRP3 and the stabilization of Nrf2. Therefore, oridonin may be a potential therapeutic agent for atherosclerosis.

The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (Majoranae herbae extractum).

Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05-101.78 µg/kg) and cadmium (0.32-0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature.

Этические аспекты фитотерапии

The review is devoted to safety issues of herbal medicinal products. Apart from the most known adverse effects such as allergic reactions and irritation ofmucous membranes, use of a number of herbal medicines results in hormonal disturbances, organotoxic reactions and CNS disturbances. The problem of intoxication is pressing in case of uncontrolled administration of herbal remedies, which is often accompanied by a carefree attitude towards them as natural and thus safe agents. This assurance is developed in the result of non-ethical advertising of dietary supplements in mass media. Finally, an important factor of safe therapy is comprehensive accounting of potential herb-herb and herb-drug interactions. The purpose of the article is to attract attention to a weighted attitude towards phytotherapy concerning its safety both in administration of traditional herbal medicinal products by doctors and during self-treatment bypatients.

Investigation of market herbal products regulated under different categories: How can HPTLC help to detect quality problems?

Background: Herbal products regulated under different categories were found to be of different quality. This has been demonstrated by the increasing number of reports on the quality of herbal products in the scientific literature. Proper identification is an effective way to address this concerning issue early on in a products’ manufacturing process. Objectives: To assess the quality of milk thistle, coneflower and black cohosh herbal drugs, preparations and products commercialized under different regulatory categories, and to illustrate the usefulness of HPTLC as a tool for evaluating quality. Methods: HPTLC methods were adapted from the European Pharmacopeia’s monographs for milk thistle fruits, black cohosh and purple coneflower. Additional detection modes beyond those described in the monographs were employed, and the entire HPTLC fingerprints were used for examination of identity and purity of the investigated samples. Results: All products regulated as Traditional Herbal Medicinal Products were shown to be of high quality: their fingerprints were consistent and without unexpected zones. A significant number of food supplements show quality issues (mainly adulterations): 52.4% of milk thistle, 33.3% of coneflower, and 45.5% of black cohosh products. The same was observed in 66.6% of black cohosh herbal drugs and preparations.

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.

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.

Traditional use and safety evaluation of combination Traditional Chinese Medicine in European registration: with XiaoYao Tablets as an example.

Mental health disorders such as stress, anxiety, depression and insomnia caused by COVID-19 have attracted worldwide attention. Traditional Chinese medicines (TCMs) have been proven to be a safe and effective option for treating mental health disorders. Recently, after assessing its efficacy and safety fully, the Netherlands Medicines Evaluation Board approved XiaoYao Tablets as a traditional herbal medicinal product (THMP), indicated for an alternative self-care for patients in Europe to relieve the symptoms of mental stress and exhaustion. Despite the fact that TCMs have gradually become one of the therapeutic choices worldwide, to-date, only a few TCMs have been successfully registered in the European Union (EU) as THMPs, and XiaoYao Tablets is the first successfully registered combination TCM from China. In this article, traditional use efficacy and clinical safety of XiaoYao Tablets in the treatment of mental health disorders were summarized and analyzed from the perspective of traditional use registration (TUR). Additionally a safety evolution pathway of combination TCMs was established. This article will not only seek to enhance our understanding about traditional use efficacy and clinical safety of XiaoYao Tablets, but also summarize the experience of XiaoYao Tablets as the first successfully registered combination TCM from China, which could serve as role model for the others to overcome registration difficulties in the EU.

Oridonin attenuates hind limb ischemia–reperfusion injury by modulating Nrf2-mediated oxidative stress and NLRP3-mediated inflammation

Ethnopharmacological relevanceOridonin (Ori), extracted from Isodon rubescens (Hemsl.) H.Hara, is a well-known traditional Chinese herbal medicinal product that possesses antioxidant and anti-inflammatory activities. Oxidative stress and inflammation are the main pathophysiological mechanisms in hindlimb IR injury. However, whether Ori has a protective effect on hind limb IR injury is unknown. Aim of the studyThe present study was designed to determine the effect of Ori on hindlimb IR injury and its relationship with oxidative stress and inflammation. Materials and methodsThe hind limb IR injury model in mice was used to evaluate the protective effect and related mechanisms of Ori. Forty-eight C57BL/6 mice (n = 12 per group) were randomly divided into four groups: Sham group; IR group; IR + Ori (10 mg/kg) group and IR + Ori (20 mg/kg) group. Mice in the IR and IR + Ori groups were subjected to hindlimb IR injury, while mice in the Sham group were subjected to no hindlimb IR injury. HE staining, Masson's staining, TTC staining, DHE staining, TUNEL staining, western blotting analysis and quantitative real-time PCR were employed to explore the mechanisms by which Ori exerts a protective effect on a classical hindlimb IR model in mice. ResultsWe found that Ori pretreatment prevented muscle damage and decreased cell apoptosis levels compared with the vehicle control. Moreover, the SOD2, CAT, MDA and ROS levels in muscle showed that Ori could significantly reduce oxidative stress in hindlimb IR mice, while the IL-1β and TNF-α levels in muscle showed that Ori could significantly attenuate IR-induced inflammation. We also found that Ori could increase the expression of Nrf2 and its downstream protein HO-1 and inhibit the expression levels of NLRP3-related proteins (NLRP3, ASC and Caspase-1) in vivo. ConclusionsOur study suggested that Ori has a protective effect on hindlimb IR injury, which may be related to Nrf2-mediated oxidative stress and NLRP3-mediated inflammasome activation.

Phytochemical and multi-biological characterization of two Cynara scolymus L. varieties: A glance into their potential large scale cultivation and valorization as bio-functional ingredients

Artichoke leaf (Cynarae folium) extracts are used as traditional herbal medicinal products to treat a wide range of human ailments, being widely commercialized as nutraceutical or pharmaceutical preparations. In the current study, the hydromethanolic dried leaf extracts of Cynara scolymus L. var. major Brotero and C. scolymus L. var. redonensis N.H.F. Desp. were phytochemically and biologically investigated. The liquid chromatography high-resolution tandem mass spectrometry (LC-HRMS/MS) metabolite profiling showed a complex composition, with phenolic acids (mostly mono- and di-caffeoylquinic acids), flavonoids and sesquiterpene lactones as the most representative classes. The strong antioxidant activity of the two C. scolymus varieties was evidenced in DPPH [64.84–65.21 mg trolox equivalents (TE)/g] and ABTS (86.39–95.55 mg TE/g) radical scavenging, cupric (160.49–171.07 mg TE/g) and ferric (71.47–78.95 mg TE/g) reducing capacity, metal chelating and phosphomolybdenum assays. In addition, the two extracts also displayed anti-enzymatic effects, as assessed in cholinesterase, tyrosinase, glucosidase and amylase tests. Lastly, the artichoke samples (at the concentration of 20 μg/mL) proved a very potent inhibition of the production of several pro-inflammatory cytokines, namely interleukin (IL)-1β [7.55–15.75% of lipopolysaccharide (LPS) + cells], IL-8 (11.72–13.46% of LPS + cells) and tumor necrosis factor (TNF)-α (4.07–10.35% LPS + cells), in LPS-stimulated human neutrophils. Overall, the results of our study indicate that the two C. scolymus varieties could be regarded as a rich source of biologically active compounds, opening thus the perspectives for their future large scale cultivation and valorization as bio-functional ingredients with putative antioxidant, anti-enzymatic and anti-inflammatory effects.

The complexity of proving health effects with data on ‘traditional use’: A critical perspective on supporting botanical health claims

BackgroundThere is considerable interest among consumers in using 'natural', plant-based nutritional supplements for their purported health benefits. However, the data required to support health claims on these so-called botanicals is subject to an ongoing debate, especially in Europe. Remarkably, pharmaceutical regulations have a provision that sometimes makes it possible to include data on 'traditional use' in the approval process. Scope and approachIn this critical perspective, we elaborate why substantiation of health benefits with evidence on traditional use is not easy to apply for food products. This is highlighted by the examples of recent incidents with traditional herbal substances such as kava kava and ephedra. These examples demonstrate that safety considerations, which are explicitly considered in the assessment of traditional herbal medicinal products, deserve special attention, and cannot be disregarded in food products that have health claims based on traditional use. Key findings and conclusionsUnexpected safety-related problems may arise when consumers combine botanicals with (prescribed) pharmaceutical products or specific nutrients, as it is often unlikely that such interactions will have been identified during traditional use. Information on both the safety and the health benefits are key to enable consumers to make the best decision for their personal health.As current legislative requirements for food products do not provide the opportunity to include both effectiveness and safety in the assessment, it is questionable whether and how traditional use evidence can be used under the current regulatory framework for health claims on foods.

Protective effect of Di'ao Xinxuekang capsule against doxorubicin-induced chronic cardiotoxicity

Ethnopharmacological relevanceDi'ao Xinxuekang capsule (DXXK) extracted from Dioscorea nipponica Makino is a well-known traditional Chinese herbal medicinal product widely used in the treatment of cardiovascular disease, such as myocardial ischemia and arrhythmia. The active ingredients of DXXK were also traditionally utilized for treating cardiovascular disease in the former Soviet Union after the 1960s. As a specific type of cardiovascular disease, doxorubicin (DOX)-induced cardiotoxicity is characterized by arrhythmia, myocardial ischemia, and heart failure. Aim of the studyThis study aimed to investigate the potential protective effect of DXXK against chronic cardiotoxicity induced by DOX. Materials and methodsA mouse model of chronic cardiotoxicity induced by DOX and an in vitro model of DOX-induced myocardial damage were created to assess the protective effect of DXXK. Cardiac functional parameters, serum levels of CK-MB and LDH and cardiac histopathological indicators were determined in the mouse model. Moreover, cell viability was measured by the MTT method, and the effect of DXXK on the anticancer activity of DOX was also investigated by utilizing 4T1, HepG2, and H460 cell lines. Furthermore, the levels of markers of oxidative stress indexes (SOD, GSH, MDA) and inflammation (TNF-α, IL-1α) were measured using biochemical and Elisa kits, respectively. The level of ROS in H9c2 cardiomyocyte was determined by flow cytometry. The protein expression levels of HIF-1α and NF-κB p65 were measured by western blotting. Finally, molecular docking was performed to visualize the patterns of interactions between the effective molecule and targeted protein. ResultsDXXK alleviated DOX-induced chronic cardiotoxicity as shown by the reversal of changes in levels of myocardial enzymes and left ventricular function and structure. DXXK exhibits antioxidant and anti-inflammatory activities. We also observed that DXXK might increase the protein expression level of HIF-1α and decrease the protein expression level of NF-κB p65. Further results of in vitro experiments showed that DXXK could protect cardiomyocyte against DOX-induced production of ROS, but DXXK had no effect on the anticancer activity of DOX. The results of molecular docking showed that dioscin and pseudoprotodioscin were the top two compounds of DXXK, which had high affinity with HIF-1α and NF-κB p65. ConclusionsOur results indicated that DXXK could protect against cardiotoxicity induced by DOX and alleviate oxidative stress and inflammation in vivo and in vitro via the regulation of HIF-1α and down NF-κB p65.

What can we learn from past and recent Bavarian knowledge for the future development of European veterinary herbal medicine? An ethnoveterinary study

Ethnopharmacological relevanceWhile the interest in finding medical solutions for the worldwide antibiotics crisis is rising, the legal possibility of simplified authorization of herbal veterinary medicinal products is dwindling.An important basis for both the preservation and development of knowledge in veterinary herbal medicine are pharmacological and clinical studies on the performance of herbal remedies, based on historical written sources on the treatment of farm animals with medicinal plants, as well as current ethnoveterinary research.Nevertheless, there is only limited systematic ethnoveterinary research in Europe, with the exceptions of the Mediterranean region, Switzerland and Austria. We conducted a survey on the ethnoveterinary knowledge of farmers in Bavaria, and analyzed two regional historical textbooks. Aim of the studyWe documented the local veterinary knowledge about livestock in Bavaria based upon local historical textbooks and upon ethnoveterinary interviews to discover opportunities for the future development of European veterinary herbal medicine. Material and methodsIn 2018/2019 we conducted 77 semi-structured interviews with 101 farmers from different types of farms. Detailed information about homemade herbal remedies (plant species, plant part, manufacturing process, source of knowledge) and the corresponding use reports (target animal species, category of use, route of administration, dosage, source of knowledge, frequency of use, last time of use and farmers’ satisfaction) were collected. To compare our data with the literature, the use reports of two local historical textbooks were analyzed and compared with the data from the interviews. Results716 homemade remedy reports (HRs) for altogether 884 use reports (URs) were documented in this study. We picked the 363 HRs that consisted of a single plant species with or without other natural products (HSHRs) for a deeper analysis. These HSHRs were prepared from 108 plant species that belonged to 57 botanical families.The most URs were documented for the families of: Asteraceae, Linaceae and Urticaceae. Calendula officinalis L. (Asteraceae), Linum usitatissimum L. (Linaceae) and Urtica dioica L. (Urticaceae) were the most often documented single species. A total of 448 URs were gathered for the 363 HSHRs. The largest number of URs was for treatments of gastrointestinal disorders and metabolic dysfunctions, followed by skin alterations and sores.For nearly half of the URs the source of knowledge was family and friends. For 80 URs the source of knowledge was different from that of the corresponding HSHRs. For 68% of the URs farmers mentioned at least one use during the last 5 years. Half of the plant species that were mentioned in the historical literature were also mentioned in URs by the interviewees. ConclusionIn Bavaria, medicinal plants are actively used by farmers to treat their livestock with a high level of satisfaction. The knowledge is not passed on from generation to generation in a purely static way, but is dynamically developed by the users in almost one fifth of the URs. Ethnoveterinary research combined with data from regional historical textbooks may facilitate pharmacological and clinical studies in veterinary medicine, and the discussion about a simplified registration for traditional herbal veterinary medicinal products.

Liquid chromatographic method for the quantification of salidroside and cinnamyl alcohol glycosides for quality control of golden root (Rhodiola rosea L.)

Rhodiola rosea L. (golden root, arctic root) is a medicinal plant encountered in traditional herbal medicinal products in Europe and in many food/dietary supplements. Salidroside and the cinnamyl alcohol glycosides, i.e. rosin, rosarin and rosavin, are characteristic constituents used as analytical markers in the quality control of the herbal material. There is a need for a validated HPLC method to be used for quality control of Rhodiola rosea products. The objective of the study was to develop and validate an HPLC-method for quantification of salidroside and the sum of rosin, rosarin and rosavin in Rhodiola rosea and closely related species. Samples of dried powered plant material were prepared by extraction with 75% methanol. An HPLC method using a CSH Fluoro-phenyl column showed to be suitable for the analysis. The content of salidroside and the sum of rosin, rosarin and rosavin, were determined. Validation showed that the chromatographic method has good selectivity with no interfering peaks. Selectivity, linearity, precision, repeatability, and accuracy were shown to be adequate. In the analyses of 27 batches of Rhodiola rosea, the average content of salidroside was 0.6% (0.3–1.5%), and for the sum of rosin, rosavin and rosarin, expressed as rosin, it was 1.4% (0.6–2.6%). As a quality standard, a minimum limit of 0.3% of salidroside and 0.6% of the sum of rosin, rosarin and rosavin could be considered for plant material of Rhodiola rosea. The method was also shown to be appropriate for quantitative determination of salidroside and the sum of rosin, rosarin and rosavin, in two other Rhodiola spp.

Sceletium for Managing Anxiety, Depression and Cognitive Impairment: A Traditional Herbal Medicine in Modern-Day Regulatory Systems.

Modern-day regulatory systems governing conditions for how health products enter national markets constitute a barrier of access for traditional herbal medicines on an international level. Regulatory intentions are focused on ensuring that consumers are being provided with safe, efficacious and high-quality products that, however, collaterally limit opportunities for traditional herbal medicinal products, especially those that do not already have a long-standing tradition of use established in the respective national marketplaces. This case study investigates and compares how a Southern African herbal medicine with great potential as an anxiolytic and mild antidepressant - Mesembryanthemum tortuosum L. [syn. Sceletium tortuosum (L.) N.E.Br.] aerial parts - fares internationally in today’s regulatory environments. It is argued that inadvertent regulatory favoritism combined with the lack of means for adequate protection of intellectual property may obstruct innovation by creating an almost insurmountable economical hurdle for successful product development and introduction of botanicals from developing countries into most of the world’s health product markets.

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

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).

A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union

The current investigation surveys the guidelines of natural medications in the India US and Europe and illuminates issues identified with their clinical preliminaries. Natural medications have been utilized for quite a while in various frameworks of wellbeing like Ayurveda, Yunani, Sidha and Homeopathy for treating number of infections. It is an exceptionally hard to perform clinical investigation on Hm’s medications in light of the fact that these medications are an unpredictable mix of dynamic fixings. It is subsequently hard to distinguish the fixing which is answerable for the remedial impact among different elements of Hm’s medications. The normalization of Hm’s medications is likewise a troublesome assignment. Notwithstanding every one of these issues are existing public interest has expanded towards natural medications in last two thirty years in light of their long history of treating the illness securely. The laws and guidelines for natural medications are distinctive in various nations. The WHO has expressed that every nation ought to have a framework to control Hm’s medications in their region. In Europe, the Committee on Herbal Medicinal Products (HMPC) was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The primary obligation of HMPC is to assess and give approval for natural medications based on their wellbeing and adequacy. In US spices are delegated dietary enhancements after the presentation of the Dietary Supplement Health and Education Act (DSHEA) in1994. In US natural medications are sorted into two kinds, first is OTC Hm’s medications and medications which required NDA endorsement. In India the Department of AYUSH has made rules for quality improvement of natural substances. The current investigation audits the guidelines of herbal medications (Hm’s) in the India US and Europe illuminates issues identified with their clinical preliminaries.