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Ocena sestave in varnosti prehranskih dopolnil in zdravil rastlinskega izvora z delovanjem na imunski sistem
ID Šarner, Laura (Author), ID Sollner Dolenc, Marija (Mentor) More about this mentor... This link opens in a new window

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Abstract
V jesenskih in zimskih mesecih, ko pogosto razsajajo prehladna obolenja, ljudje večinoma najprej posežejo po izdelkih brez recepta, dostopnih v lekarnah, na spletu ali v specializiranih trgovinah. Pri prehranskih dopolnilih se ne zahteva preverjanje vsebnosti aktivnih sestavin, kot pri zdravilih, zato ni zagotovila, da so varna in učinkovita. Namen magistrske naloge je bil oceniti sestavo in varnost izdelkov, ki se pri nas prodajajo za podporo imunskemu sistemu ali pa vsebujejo vsaj eno sestavino, ki modulira njegovo delovanje. Skupno smo izbrali 45 sestavin, podrobneje smo jih opisali 12, ki so se v izdelkih najpogosteje pojavile samostojno ali v kombinaciji. Proučili smo 6 zdravil rastlinskega izvora in 107 prehranskih dopolnil. Na podlagi odmerkov sestavin, uporabljenih v pregledanih študijah, smo poiskali odmerke sestavin, ki v izdelkih vplivajo na delovanje imunskega sistema. Poiskali smo še podatke o varnih odmerkih, neželene učinke, ki jih lahko sestavine povzročijo, in morebitne interakcije z zdravili. Vseh 6 zdravil smo opredelili kot učinkovite in varne za krepitev odpornosti, od prehranskih dopolnil pa jih je 67,3 % takšnih, katerih uporaba je, glede na našo oceno, upravičena za podporo imunskemu sistemu. Manjši delež dopolnil bi lahko bil, glede na rezultate študij, ustrezen tudi pri avtoimunih boleznih in preobčutljivostnih reakcijah (9,3 %) ter imunski pomanjkljivosti (2,8 %), vendar bi bilo za potrditev potrebnih še več dobro zasnovanih študij. V zdravilih se, kot edina sestavina za to indikacijo, pojavlja ameriški slamnik, ki je poleg beta-glukanov tudi najpogosteje prisoten v prehranskih dopolnilih. Od izbranih sestavin je edina zdravilna rastlina, ki ima monografijo Evropske agencije za zdravila za lajšanje simptomov prehlada, katerega učinke so potrdile klinične študije. Za črni bezeg, česen in pelargonijo pa učinki temeljijo na dolgoletni tradicionalni uporabi. Za krepitev odpornosti ocenjujemo, da so, na podlagi pregledane literature, za ta namen ugodna zdravila rastlinskega izvora in dopolnila, ki v ustreznih odmerkih vsebujejo omenjene rastline ter dopolnila z beta-glukani, propolisom in probiotiki. Za 20 prehranskih dopolnil (18,7 %) smo ugotovili, da presegajo dnevne odmerke nekaterih sestavin, predvsem vitaminov in mineralov, glede na vrednosti, ki jih dovoljuje Javna agencija Republike Slovenije za zdravila in medicinske pripomočke. 14 prehranskih dopolnil (13,1 %) pa vsebuje sestavine, za katere varnostnih študij nismo našli oziroma se rastlinska droga v le-teh ni nahajala v enaki obliki, kot v izdelkih. Najpogosteje so se v dopolnilih pojavili še vitamin C (41,1 %), cink (40,2 %), vitamin D (29,9 %), selen (15,9 %) in vitamin B6 (12,1 %). Ugotovili smo, da lahko morebitne interakcije z zdravili povzroči 19 sestavin, ki smo jih v raziskavi uvrstili med tiste, ki prispevajo k modulaciji imunskega sistema.

Language:Slovenian
Keywords:prehranska dopolnila, zdravila rastlinskega izvora, imunomodulacija, sestava, varnost
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2024
PID:20.500.12556/RUL-162684 This link opens in a new window
Publication date in RUL:26.09.2024
Views:164
Downloads:34
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Secondary language

Language:English
Title:Composition and safety assessment of dietary supplements and herbal medicines acting on immune system
Abstract:
In autumn and winter months, when common cold often spreads, people tend to buy over-the-counter products first, which they can get at a pharmacy, in specialized stores or online. Unlike medicines, dietary supplements don't require testing of active compounds, that is why there is no assurance they are safe and effective. The purpose of the master’s thesis was to assess the composition and safety of products on our market, that support the immune system or contain at least one ingredient, that modulates its action. We selected 45 ingredients in total and described 12 of them in detail, which were mostly found in the products alone or in combination. We selected 6 herbal medicines and 107 dietary supplements. Based on the doses of ingredients, used in clinical studies, we searched for doses of ingredients, that modulate immune system, in the reviewed products. We also collected information on safe dosages and side effects the ingredients may cause, as well as potential drug interactions. All 6 medicines are effective and safe for strengthening the immune system and 67,3 % of dietary supplements were found to be justified for immune system support. A small number of supplements could also be used in autoimmune diseases and hypersensitivity reactions (9,3 %) and immunodeficiency (2,8 %), according to results of studies, but more well-designed researches are needed to confirm this. The only ingredient in medicines, for this indication, is purple coneflower, which is, in addition to beta-glucans, also the most common ingredient, found in dietary supplements. Of the selected ingredients, it is the only medicinal plant, that has its own herbal monograph of European Medicines Agency for the relief of cold symptoms, its effects have also been confirmed in clinical studies. For elderberry, garlic and geranium, effects are just based on their traditional use. In order to strengthen the immune system, we estimate that, on the basis of the reviewed literature, herbal medicines and supplements containing these plants in appropriate doses, as well as supplements with beta-glucans, propolis and probiotics, are beneficial for this purpose. 20 dietary supplements (19,4 %) exceeded the daily doses of certain ingredients, mostly vitamins and minerals, according to the doses permitted by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. In addition, 14 dietary supplements (13,6 %) contained ingredients, for which we didn't find safety studies or herbal drug wasn't in the same form, as in the reviewed products. The most common in supplements were also vitamin C (41,1 %), zinc (40,2 %), vitamin D (29,9 %), selenium (15,9 %) and vitamin B6 (12,1 %). We found that 19 ingredients, which we classified as those that contribute to the immunomodulation, can cause potential drug interactions.

Keywords:dietary supplements, herbal medicines, immunomodulation, composition, safety

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