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1.
Molecules ; 27(17)2022 Aug 28.
Article in English | MEDLINE | ID: mdl-36080297

ABSTRACT

This study aimed to evaluate the impact of widely grown fruits (wild roses, elderberries, sea buckthorns, rowans, chokeberries, and hawthorns) as a functional ingredient in wheat-flour cookie formulation on antioxidative properties with a simultaneous reduction of the carcinogen-like compound acrylamide. The organoleptic features of the cookies were assessed by a panel of consumers. The following parameters were measured: chemical composition, total polyphenols, polyphenolic profile, antioxidant activity, and acrylamide content. The overall ratings of the tested cookies with the addition of chokeberries, hawthorns, sea buckthorns, and elderberries were more than satisfactory, while wild rose and rowan cookies were the most widely accepted and best rated by the panelists. The antioxidant activity of the tested cookies was 1.1−15.22 µmol trolox·g−1 dm and 2.46−26.12 µmol Fe (II)·g−1 dm as measured by the ABTS and FRAP methods, respectively. All the fruit-enriched cookies had significantly higher antioxidative properties (p < 0.05) in comparison to the control cookies, but among the fruit-enriched cookies, there were differences in the quality and quantity of particular polyphenols. The acrylamide content was significantly decreased by 59% (hawthorn), 71% (rowan), 87% (wild rose), 89% (sea buckthorn), 91% (elderberry), and 94% (chokeberry) compared with the control cookies (p < 0.05). Cookies enriched with wild-grown fruits could constitute a promising novel snack food.


Subject(s)
Sambucus , Sorbus , Acrylamide/analysis , Antioxidants/chemistry , Flour/analysis , Fruit/chemistry , Polyphenols/analysis , Triticum/chemistry
2.
Foods ; 11(3)2022 Jan 27.
Article in English | MEDLINE | ID: mdl-35159521

ABSTRACT

BACKGROUND: elemental deficiency may result in the malfunctioning of human organisms. Sprouts, with their attractive looks and well-established popularity, may be considered as alternative sources of elements in the diet. Moreover, the uptake of micro- and macronutrients from sprouts is better when compared to other vegetable sources. The aim of the study was to determine and compare the level of the selected essential minerals and trace elements in 25 sprouts from different botanical families, to preselect the richest species of high importance for human diets. METHODS: the Cu, Zn, Mn, Fe, Mg, Ca determinations were performed using atomic absorption spectrometry with flame atomization and iodine by the colorimetric method. RESULTS: beetroot sprouts had the highest levels of Zn, Fe, and Mg, while onion sprouts were the richest in Mn and Ca, among all of the tested sprouts. Sprouts of the Brassicaceae family were generally richer in Ca, Mg, and Zn than sprouts from the Fabaceae family. Results allow preselection of the most perspective sprouts as possible dietary sources of essential minerals and trace elements. For rucola, leeks, onions, and beetroot sprouts, the data on minerals and trace element compositions were performed for the first time.

3.
Biol Trace Elem Res ; 200(4): 1981-1987, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34331663

ABSTRACT

Essential elements like Cu, Mn and Zn are extremely important for herbs' growth and physiological functions; however, from a toxicological point of view, the exposure of these elements (as essential elemental impurities) can exhibit potential harmful effects for patients. In Europe, very popular are ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products for adjunctively in rhinitis (runny nose). Based on posology of ointments with Marjoram herb extract, the exposure to these elemental impurities may be high during long-term use. Hence, the aim of this article is the health risk assessment of essential elemental impurities (Cu, Mn and Zn) through the dermal exposure of ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products applied adjunctively in rhinitis available in Polish pharmacies. The investigated essential elements were determined by well-validated methodology (R > 0.997, recoveries, LOD and LOQ values were acceptable) based on flame atomic absorption spectrometry (FAAS). Our results indicated that all analysed herbal medicinal products with Marjoram herb extract available in Polish pharmacies contain relatively low levels of essential element impurities, i.e. Cu (0.14-0.49 mg/kg), Mn (0.31-2.57 mg/kg) and Zn (0.73-3.19 mg/kg). The estimated exposure of the investigated elemental impurities confirms the safety of all products. To the best of our knowledge, the study about Cu, Mn and Zn contents in HMPs with Majoranae herbae extractum is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view due to ICH Q3D elemental impurity guideline for pharmaceuticals.


Subject(s)
Origanum , Plants, Medicinal , Trace Elements , Humans , Ointments , Plants, Medicinal/chemistry , Risk Assessment , Zinc/analysis
4.
Biol Trace Elem Res ; 200(6): 2983-2988, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34373977

ABSTRACT

Scientific reports about elemental impurities in final pharmaceutical products are essential from a regulatory point of view; unfortunately, there is a lack of studies about this important toxicological topic. The aim of our short communication was determination of total Cr impurities in traditional herbal medicinal products (THMP) with Thymi herba (Thymus vulgaris L. and Thymus zygis L.) available in Polish pharmacies (n = 6, because only six manufacturers produce this kind of pharmaceutical products in Poland). The total content of Cr impurities was determined by atomic absorption spectrometry using electrothermal atomization (ETAAS). Applied comprehensive toxicological risk assessment was based on three main tiers: Tier 1, the comparison of raw results as total Cr impurities profile (metal per L of THMP) with ICH Q3D guideline standards; Tier 2, the estimation of total Cr exposure with a single dose; and Tier 3, the estimation of total Cr daily exposure. We confirmed that total Cr impurities were present in all analyzed THMP with thymi herba (the observed level was below 6.0 µg/L). Total Cr concentration in a single dose can be deceptively high in comparison to the raw results but is not a threat to patients (20.15-63.45 ng/single dose). Moreover, the estimation of total Cr daily exposure shows that all analyzed THMP are characterized by daily dose (40.30-181.41 ng/day) below PDE value (10,700 mg/day); hence, all products meet the standards of ICH Q3D elemental impurities guideline.


Subject(s)
Pharmacies , Plants, Medicinal , Thymus Plant , Chromium/analysis , Humans , Plant Extracts , Plants, Medicinal/chemistry , Poland
5.
Biol Trace Elem Res ; 200(6): 2963-2969, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34373979

ABSTRACT

Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 - 20.6 µg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the 'worst-case scenario' (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.


Subject(s)
Pharmacies , Plantago , Plants, Medicinal , Cadmium/analysis , Humans , Pharmaceutical Preparations , Plant Leaves/chemistry , Plants, Medicinal/chemistry , Poland , Risk Assessment , Vegetables
6.
Biol Trace Elem Res ; 200(2): 904-909, 2022 Feb.
Article in English | MEDLINE | ID: mdl-33792859

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).


Subject(s)
Pharmacies , Sleep Wake Disorders , Valerian , Cadmium/analysis , Humans , Lead , Plant Extracts , Poland , Risk Assessment
7.
Biol Trace Elem Res ; 200(4): 1949-1955, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34109550

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).


Subject(s)
Pharmaceutical Preparations , Pharmacies , Valerian , Plant Extracts , Poland , Risk Assessment , Zinc/analysis
8.
Biol Trace Elem Res ; 200(4): 1965-1971, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34191216

ABSTRACT

For elemental impurities that have been studied for transcutaneous absorption, the available data are rarely suitable for proper toxicological risk assessment - there are multiple factors that can influence this dermal absorption. Hence, in our studies, we applied generic and conservative approach - cutaneous permitted daily exposure (CPDE) described in International Conference on Harmonisation's Q3D Guideline on Elemental Impurities (ICH Q3D). The aim of this article is toxicological risk assessment (TRA) 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 (n = 5, because only five manufacturers produce this kind of pharmaceutical products in Poland). To make the appropriate TRA approach, we considered (1) raw results (metal per kg of ointment), (2) one-time administration of applied ointments, and (3) daily exposure versus CPDE. Due to the fact the concentrations of Ni generally present in cutaneous products as impurities are not considered sufficient to induce sensitization, the cutaneous and transcutaneous concentration limits (CTCLs) approach was applied for this element assessment. The toxicological analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomization atomic absorption spectrometry. Our results show that the ointments with Marjoram herb extract from pharmacies in Poland represent a potential health hazard to patients; however, there may be a requirement for the monitoring of impurities of nickel in future. To the best of our knowledge, this paper is the first study about nickel and chromium content in ointments with Marjoram herb extract (Majoranae herbae extractum).


Subject(s)
Origanum , Pharmacies , Chromium/analysis , Chromium/toxicity , Humans , Nickel/analysis , Nickel/toxicity , Ointments , Plant Extracts/toxicity , Poland , Risk Assessment
9.
Phytochemistry ; 192: 112948, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34530281

ABSTRACT

In the present study, quantitative analysis of usnic acid and the selected elements (Ag, Ca, Cd, Cr, Cu, Mg, Mn, Ni, Pb, Zn) in samples of Cladonia mitis thalli collected along a North-Central Europe transect, was performed. Additionally, we analysed geographical and environmental factors that could potentially influence the levels of the analytes. With the constructed partial least square (PLS) chemometric model we aimed to establish the relationships between the analysed factors. Our study is the first to provide comparative quantitative data on usnic acid in C. mitis. We proved this lichen species is a rich source of usnic acid (4.52 ± 0.54-21.58 ± 2.23 mg/g dry wt). Significant differences in usnic acid content between samples collected in the open and forest areas were noted, with the predominance of the former (mean 17.4 ± 2.8 and 8.8 ± 2.3 mg/g dry wt, respectively). Our results supported the hypothesis on the relationship between usnic acid and selected heavy metals content in lichens, as the positive correlation of the compound was noted with Pb. Our PLS model indicated also a positive correlation between usnic acid and Cr content, which was reported for the first time.


Subject(s)
Benzofurans , Lichens , Metals, Heavy , Ascomycota
10.
Viruses ; 13(7)2021 07 15.
Article in English | MEDLINE | ID: mdl-34372587

ABSTRACT

Distinguishing between severe and nonsevere COVID-19 to ensure adequate healthcare quality and efficiency is a challenge for the healthcare system. The aim of this study was to assess the usefulness of CBC parameters together with analysis of FLC serum concentration in risk stratification of COVID-19. MATERIALS AND METHODS: CBC was analyzed in 735 COVID ICU, COVID non-ICU, and non-COVID ICU cases. FLC concentration was analyzed in 133 of them. RESULTS: COVID ICU had neutrophils and lymphocytes with the greatest size, granularity, and nucleic acid content. Significant differences in concentrations of κ and λ FLCs were shown between COVID ICU and COVID non-ICU. However, no difference was found in the κ/λ ratio between these groups, and the ratio stayed within the reference value, which indicates the presence of polyclonal FLCs. FLC κ measurement has significant power to distinguish between severe COVID-19 and nonsevere COVID-19 (AUC = 0.7669), with a sensitivity of 86.67% and specificity of 93.33%. The κ coefficients' odds ratio of 3.0401 was estimated. CONCLUSION: It can be concluded that the results obtained from the measure of free light immunoglobulin concentration in serum are useful in distinguishing between severe and nonsevere COVID-19.


Subject(s)
COVID-19/immunology , Immunoglobulin Light Chains/blood , SARS-CoV-2/immunology , Aged , Aged, 80 and over , C-Reactive Protein/immunology , COVID-19/blood , COVID-19/diagnosis , COVID-19 Serological Testing , Female , Ferritins/immunology , Humans , Immunoglobulin Light Chains/immunology , Intensive Care Units , Interleukin-6/immunology , Male , Middle Aged , Retrospective Studies , Sensitivity and Specificity , Severity of Illness Index
11.
Regul Toxicol Pharmacol ; 123: 104945, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33991634

ABSTRACT

Elemental impurities (EIs) profiling in final pharmaceutical products is often not adequately treated, however it is crucial problem in pharmaceutical analysis by reason of the various regulatory authorities (like ICH Q3D guideline). EIs in pharmaceuticals may arise from numerous sources of which the herbal ingredients are not a frequent subject of pharmaceutical analyses. However, based on number of traditional use registrations per year for herbal medicinal products (HMPs) in the EU, it can be stated that monocomponent HMPs are still very popular for use. Due to the high frequency of use, exposure to EIs from HMPs may be high during long-term use. The aim of our article was Ni and Cr impurities profiling of Valeriana officinalis L., radix (Valerian root) as an example of the HMP available in Polish pharmacies for the relief of mild nervous tension and sleep disorders. The choice of metals was justified by: (1) a single dose of Ni administered via oral route can induce dermatitis in nickel-sensitised individuals; (2) Cr is a very problematic element from toxicological point of view. Our results indicate that the standards of the ICH Q3D guideline are met for all EIs.


Subject(s)
Hazardous Substances/analysis , Plants, Medicinal/chemistry , Valerian/chemistry , Chromium/analysis , Drug Contamination , Nickel/analysis , Pharmacies , Poland
12.
Am J Hypertens ; 32(9): 848-857, 2019 08 14.
Article in English | MEDLINE | ID: mdl-31102435

ABSTRACT

BACKGROUND: Insulin resistance and renal tubular sodium handling influence arterial structure and function and play an essential role in salt-sensitive forms of hypertension. METHODS: In a population with prevailing sodium consumption, we assessed the relationship between cardiovascular phenotypes (peripheral and central blood pressures, elastic properties of large arteries, the left ventricular structure) and sodium handling parameters (daily urinary sodium excretion, fractional urinary lithium excretion in proximal-FELi and distal tubules), as a function of insulin sensitivity-measured by homeostasis model assessment-insulin resistance (HOMA-IR), leptin-to-adiponectin (L/A) ratio, and homeostasis model assessment-adiponectin (HOMA-AD). RESULTS: In patients with FELi below the median value (corresponding to the group with increased proximal sodium reabsorption) and higher insulin resistance as measured by HOMA-IR, pulse wave augmentation indexes were significantly higher-AIxP (99.4% vs. 86.2%; P = 0.007), AIxC1 (159.4% vs. 144.2%; P = 0.04), and AIxC2 (36.1% vs. 28.3%; P = 0.02), than in patients with lower insulin resistance. The same trend was observed in relation to L/A ratio-AIxP (98.7% vs. 87.1%; P = 0.005), AIxC1 (158.6% vs. 144.5%; P = 0.02), and AIxC2 (35.6% vs. 28.5%; P = 0.01) and HOMA-AD-AIxP (99.7% vs. 83.8%; P = 0.001), AIxC1 (160.5% vs. 140.3%; P = 0.007), and AIxC2 (36.6% vs. 26.3%; P = 0.003). Such relationships were not observed in patients with FELi above the median value. CONCLUSIONS: In the hypertensive population with prevailing sodium intake, insulin resistance and increased sodium reabsorption in proximal tubules may affect arterial wall function.


Subject(s)
Arterial Pressure , Hypertension/etiology , Insulin Resistance , Kidney Tubules/physiopathology , Natriuresis , Sodium, Dietary/adverse effects , Vascular Stiffness , Aged , Female , Humans , Hypertension/diagnosis , Hypertension/physiopathology , Hypertension/urine , Kidney Tubules/metabolism , Male , Middle Aged , Renal Elimination , Renal Reabsorption , Sodium, Dietary/urine , Ventricular Dysfunction, Left/etiology , Ventricular Dysfunction, Left/physiopathology , Ventricular Function, Left , Ventricular Remodeling
13.
J Trace Elem Med Biol ; 53: 109-112, 2019 May.
Article in English | MEDLINE | ID: mdl-30910192

ABSTRACT

The monitoring of elemental impurities (EIs) in pharmaceutical materials is often not adequately treated, although it is a very important topic because the directive ICH Q3D requires a wide range of elements, often at low concentrations, to be monitored. This article describes the quantitative toxicological analysis of copper, manganese and zinc as EIs in the pharmaceutical gels for teething containing herbs available in Poland. The levels of EIs were measured to evaluate whether the intake of these metals through the gels was within recommended levels. The flame absorption spectrometry (FAAS) following microwave induced digestion (concentrated nitric acid) was applied to determine the levels of Cu, Mn and Zn in the products. This article was motivated especially by the facts that: (i) herbs can be a potential source of EIs; (ii) Cu, Mn and Zn are essential trace elements in the infancy period; (iii) there is a general lack of data around the risk assessment associated with exposure to these EIs in this kind of pharmaceutical. Our safety assessment is based on triple approach including: (1) profile of EIs in gels; (2) the actual amount of EIs in the appropriate amount of gel applied with a single administration (one drop) and (3) the daily exposure of EIs in analysed teething pharmaceuticals due to the maximum daily dose. Our results show that all EI levels meet the standards of directive ICH Q3D. It can be concluded that all of the teething gels investigated, based on herbs, available in Polish pharmacies do not represents a health hazard to babies.


Subject(s)
Copper/adverse effects , Drug Contamination , Manganese/adverse effects , Pharmaceutical Preparations/chemistry , Pharmacies , Plants, Medicinal/chemistry , Tooth Eruption/drug effects , Zinc/adverse effects , Adult , Copper/analysis , Humans , Manganese/analysis , Plant Preparations/chemistry , Poland , Zinc/analysis
14.
J Trace Elem Med Biol ; 53: 144-149, 2019 May.
Article in English | MEDLINE | ID: mdl-30910198

ABSTRACT

BACKGROUND: Prescription food for special medical purposes (FSMPs) and modified milk products (MMPs), available in pharmacies, are important for newborns and infants that are not breastfed. In the scientific literature there is a lack of comprehensive studies and corresponding safety assessment of the essential trace elements in these products. OBJECTIVE: The aim of this article was determination of Cu, Mn and Zn levels in the most frequently available prescription FSMPs (n = 6) and MMPs (n = 6) available in Polish pharmacies. METHODS: Flame absorption spectrometry (FAAS) following microwave induced digestion (concentrated nitric acid) was applied to determine the levels of the elements in the products. RESULTS: Our studies are based on a triple approach (1) the "raw results" of Cu, Mn and Zn levels (products in powdered form), (2) single intake - the level of each essential trace element consumed in one portion, (3) the daily intake depending on age and weight including comparison with Adequate Intake established by European Food Safety Authority. CONCLUSION: The results show the occurrence of differences between the manufacturer's declared composition and the finished product for consumption. The prescription FSMPs in comparison to MMPs available in Polish pharmacies contain similar levels of Cu, Mn and Zn. Our results show additionally that all of the products do not represent a health hazard to the newborns and infants. This is a pioneer study in terms of the safety assessment, and quality of prescription FSMPs and MMPs available in Polish pharmacies from toxicological and nutritional point of view.


Subject(s)
Copper/analysis , Manganese/analysis , Milk, Human/chemistry , Pharmacies , Prescription Drugs/chemistry , Zinc/analysis , Humans , Infant , Infant, Newborn , Microwaves , Poland
15.
J Trace Elem Med Biol ; 52: 18-21, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30732880

ABSTRACT

Studies related to the toxicological analyses of metallic impurities in pharmaceuticals (drugs) is an important issue but there is a lack of refereed literature around the safety of teething remedies from herbal origin related to toxic metals impurities. In this article, the levels of Pb and Cd were measured in samples of local anaesthetics for teething (gels) based on herbs. This article was motivated by the fact that Pb and Cd are relevant toxic metals that may cause an adverse effect in babies even at low levels. Additional justifications were (1) the insufficient control of metal impurities in teething gels, (2) the lack of sufficient validation steps and (3) the inadequate sensitivity of applied analytical techniques. The aim of this article was a qualitative and quantitative analysis of Pb and Cd in the most popular and available local anaesthetic for teething (teething gels) based on herbs (n = 5) available in Poland. Metals were determined by ET AAS (electrothermal atomization atomic absorption spectrometry), after digestion in a microwave unit using concentrated nitric acid. It was observed that all samples contained Pb and Cd. The levels of Pb and Cd as impurities (independently of the producer and declared composition) are similar. The concentrations of Pb and Cd, at ng/day levels, to which the user is exposed at daily doses meet the standards of the directive ICH Q3D.


Subject(s)
Anesthetics, Local/chemistry , Cadmium/analysis , Cadmium/toxicity , Electrochemical Techniques , Herbal Medicine , Lead/analysis , Lead/toxicity , Tooth Eruption/drug effects , Humans , Pharmacies , Plant Extracts/chemistry , Poland , Spectrophotometry, Atomic
16.
Biol Trace Elem Res ; 192(2): 129-135, 2019 Dec.
Article in English | MEDLINE | ID: mdl-30783920

ABSTRACT

Prescription food for special medical purposes (FSMPs) and modified milk products (MMPs) for babies in the infancy period available in pharmacies are increasingly frequently used for newborns and infants-especially in cases where allergies and food-borne diseases are diagnosed. However, there is a lack of scientific study around the safety assessment of the elemental impurities in these products. Importantly, the allergen Ni and the problematic metal Cr are little considered. Hence, the aim of this article was the toxicological analysis of Ni and Cr impurities in prescription FSMPs (n = 6) and MMPs (n = 6) for newborns and infants available in Polish pharmacies. For the best safety assessment, we include three approaches including (1) the levels of Ni and Cr in powdered products, (2) assessment of the daily dose depending on age and body weight of newborns and infants, and (3) the weekly intake of Ni and Cr in samples in comparison to provisional tolerable weekly intake (PTWI). Our results show that, on the basis of our data, the products from pharmacies in Poland investigated in this study do not represent a real health hazard to newborns and infants, although there may be a requirement for the monitoring of levels of Ni. Our results are pioneer and provide valuable data for other scientists and manufacturers.


Subject(s)
Chromium/analysis , Dairy Products/analysis , Food Analysis , Food Contamination/analysis , Milk/chemistry , Nickel/analysis , Pharmacies , Animals , Humans , Infant , Infant, Newborn , Poland
17.
Biol Trace Elem Res ; 191(2): 517-521, 2019 Oct.
Article in English | MEDLINE | ID: mdl-30684140

ABSTRACT

Control of elemental impurities (EIs) in pharmaceutical herbal products is currently important but not a very popular topic in modern toxicological analysis. The occurrence and concentration of EIs in the pharmaceutical herbal products should be controlled and meet the standards of directive International Conference on Harmonisation's Q3D Guideline on Elemental Impurities. An interesting area of interest is measuring EIs including toxic and allergic metals in pharmaceutical herbal products for teething. The aim of this article was determination of Ni and Cr impurities in pharmaceutical herbal products for teething available in Polish pharmacies. Justifications were (1) herbs as an important source of EIs and (2) infants may be particularly sensitive to the toxic effects of metals because they tend to absorb a higher fraction of an oral dose. The analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomisation atomic absorption spectrometry. The safety assessment involved a triple approach: (1) level of Ni and Cr impurities in pharmaceutical samples; (2) level of Ni and Cr impurities including one-time administration of teething gels and (3) daily intake of metals. In all three cases, the results indicate that the standards of directive ICH Q3D are met for Ni and Cr. Overall, it can be concluded that none of the teething gels represents a health hazard to infants.


Subject(s)
Chromium/adverse effects , Nickel/adverse effects , Pharmaceutical Preparations/analysis , Trace Elements/adverse effects , Humans , Infant , Poland
18.
J Trace Elem Med Biol ; 51: 73-78, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30466941

ABSTRACT

There is currently a lack of risk assessments around Pb and Cd in prescription food for special medical purposes (FSMPs) and modified milk products available in from pharmacies in Poland. This article describes and evaluates a toxicological analysis of lead and cadmium in prescription FSMPs (n = 6) and modified milk products (n = 6) available in Polish pharmacies. The metals were determined using electrothermal atomisation atomic absorption spectrometry. To make the appropriate risk assessment, we considered (1) the levels of lead and cadmium in a powdered product, (2) the amount of the metals consumed in one portion (single exposure), (3) the daily dose depending on age (months) and body weight and (4) the weekly intake of Pb and Cd in samples in comparison to provisional tolerable weekly intake (PTWI). The results demonstrated that the samples analysed do not represent a health hazard to newborns and infants. This study is important because of the concerns around the complex risk assessment of prescription FSMP's and modified milk products available in Polish pharmacies related to lead and cadmium.


Subject(s)
Cadmium/analysis , Lead/analysis , Milk/chemistry , Prescription Drugs/chemistry , Adult , Animals , Cadmium/adverse effects , Humans , Infant , Infant, Newborn , Lead/adverse effects , Poland
19.
Biomed Pharmacother ; 97: 82-90, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29080462

ABSTRACT

Broccoli sprouts may exert a negative influence on thyroid function as they are a rich source of glucosinolates, in particular glucoraphanin. Under the study in a long-term experiment broccoli sprouts were tested as an element of rats diet, combined with deficient iodine, or sulfadimethoxine ingestion - two models of hypothyroidism. Evaluations were performed for serum TSH and thyroid hormones completed with analyzes of selected haematological, biochemical and immunological (IL-6, IL-10) parameters, as well as cytosolic glutathione peroxidase (GPX1), thioredoxin reductase (TR) in the thyroid, and plasma glutathione peroxidase (GPX3). A thermographic analysis was conducted to provide auxiliary indicators for determining a potential thyroid dysfunction under the specific experimental conditions. The levels of TSH, fT3 and fT4 remained unchanged following broccoli sprouts ingestion, which was even found to have a protective effect against sulfadimethoxine induced thyroid damage. Moreover, TR activity significantly increased in response to sprouts ingestion. In animals with hypothyroidism, broccoli sprouts were found to exert a beneficial influence on the antioxidant balance of the thyroid gland. In comparison to the rats with iodine deficiency, broccoli sprouts addition to the diet was observed to decrease IL-6 level. No significant differences in IL-10 concentration were determined. Neither addition of broccoli sprouts to the diet, nor sulfadimethoxine and iodine deficiency, caused negative changes in red blood cell parameters, glucose and uric acid concentrations, or kidney function. However, such a dietary intervention resulted in reduced WBC and PLT levels, and it may adversely interfere with liver function in rats, most likely due to a higher dietary intake of glucosinolates.


Subject(s)
Brassica , Hypothyroidism/drug therapy , Plant Extracts/therapeutic use , Seedlings , Thyroid Gland/drug effects , Animals , Hypothyroidism/blood , Hypothyroidism/immunology , Male , Plant Extracts/isolation & purification , Plant Extracts/pharmacology , Rats , Rats, Wistar , Thyroid Gland/immunology , Thyroid Gland/metabolism , Treatment Outcome
20.
Rocz Panstw Zakl Hig ; 58(1): 35-40, 2007.
Article in English | MEDLINE | ID: mdl-17711088

ABSTRACT

The objective of our study was evaluation antioxidant activity of Amaranthus cruentus grain and by-products (flour, cereals and popping). The evaluation was performed by FRAP, DPPH and ABTS methods. FRAP and ABTS assays gave comparable results, DPPH method gave lower values. Among by-products cereal had the highest activity as the least processed product. Additionally, antioxidant capacities of two cultivars of amaranth (varieties Aztek and Rawa) were compared and the influence of grain soaking on antioxidant properties was taken into account. It was found, that soaking decreased antioxidant activity of amaranth seed.


Subject(s)
Amaranthus/metabolism , Antioxidants/metabolism , Edible Grain/metabolism , Flour/analysis , Plant Structures/metabolism , Seeds/metabolism , Amaranthus/chemistry , Amaranthus/classification , Amino Acids/analysis , Amino Acids/chemistry , Antioxidants/classification , Edible Grain/chemistry , Food/standards , Free Radical Scavengers/analysis , Free Radical Scavengers/metabolism , Plant Structures/chemistry
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