IT202000021907A1 - Composition nutraceutical multipurpose - Google Patents
Composition nutraceutical multipurpose Download PDFInfo
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- IT202000021907A1 IT202000021907A1 IT102020000021907A IT202000021907A IT202000021907A1 IT 202000021907 A1 IT202000021907 A1 IT 202000021907A1 IT 102020000021907 A IT102020000021907 A IT 102020000021907A IT 202000021907 A IT202000021907 A IT 202000021907A IT 202000021907 A1 IT202000021907 A1 IT 202000021907A1
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- nutraceutical composition
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- moringa
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K20/00—Accessory food factors for animal feeding-stuffs
- A23K20/10—Organic substances
- A23K20/111—Aromatic compounds
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
- A23L27/30—Artificial sweetening agents
- A23L27/33—Artificial sweetening agents containing sugars or derivatives
- A23L27/36—Terpene glycosides
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
- A23L33/155—Vitamins A or D
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Polymers & Plastics (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mycology (AREA)
- Nutrition Science (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Botany (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Animal Husbandry (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Fats And Perfumes (AREA)
- Jellies, Jams, And Syrups (AREA)
- Materials For Medical Uses (AREA)
Description
Titolo: ?COMPOSIZIONE NUTRACEUTICA POLIVALENTE? Title: ?MULTIPURPOSE NUTRACEUTICAL COMPOSITION?
DESCRIZIONE DESCRIPTION
SETTORE DELLA TECNICA TECHNICAL SECTOR
La presente invenzione si riferisce al settore farmaceutico - nutrizionale denominato: NUTRACEUTICO. Nel dettaglio la presente invenzione si riferisce ad una nuova composizione molecolare, di origine naturale, ad alto contenuto scientifico e tecnologico. Attraverso una miscela di estratti di tre piante officinali, di un flavonoide e di vitamine del gruppo D, sinergicamente complementari tra loro, comprendenti principi bioattivi benefici per lo stato di salute dell?organismo umano. La composizione nutraceutica in oggetto si presta ad essere utilizzata come integratore alimentare ?polivalente?, in formulazione liquida orale, che ha anche lo scopo di coadiuvare il trattamento di alcune malattie autoimmuni. The present invention refers to the pharmaceutical - nutritional sector called: NUTRACEUTIC. In detail, the present invention refers to a new molecular composition, of natural origin, with a high scientific and technological content. Through a blend of extracts of three medicinal plants, a flavonoid and group D vitamins, synergistically complementary to each other, including bioactive principles beneficial to the state of health of the human organism. The nutraceutical composition in question lends itself to being used as a "multipurpose" food supplement, in an oral liquid formulation, which also has the purpose of assisting the treatment of some autoimmune diseases.
STATO DELL? ARTE STATE OF ART
La parola NUTRACEUTICA ? un neologismo sincratico da "nutrizione" e "farmaceutica"; i nutraceutici sono quei principi nutritivi contenuti negli alimenti che hanno effetti benefici sulla salute. The word NUTRACEUTICAL? a syncretic neologism from "nutrition" and "pharmaceutical"; nutraceuticals are those nutrients contained in foods that have beneficial effects on health.
Le quantit? minime di sostanze nutritive necessarie per ottenere dei benefici, sono disciplinate da regolamenti europei (es. Regolamento 432/2012) nei quali vengono elencati i CLAIM (frasi esplicative del beneficio procurato) utilizzabili, e approvati dal Ministero della Salute. The quantities? minimum levels of nutrients necessary to obtain benefits, are governed by European regulations (e.g. Regulation 432/2012) which list the usable CLAIMs (explanatory sentences of the benefit provided), and approved by the Ministry of Health.
Gli alimenti nutraceutici vengono comunemente anche definiti alimenti funzionali, pharma food o farmalimenti. Questi sono tali se l'alimento e/o la pianta officinale contiene naturalmente i nutrienti nelle quantit? minime richieste dai regolamenti, oppure se vengono addizionati con estratti nutraceutici concentrati. Tipicamente vengono utilizzate per prevenire le malattie croniche e migliorare lo stato di salute. Studi scientifici autorevoli ne certificano ormai da decenni le loro naturali funzionalit?. Nutraceutical foods are also commonly referred to as functional foods, pharma foods or pharmaceuticals. These are such if the food and/or the medicinal plant naturally contains the nutrients in the quantities? required by the regulations, or if they are added with concentrated nutraceutical extracts. They are typically used to prevent chronic disease and improve health. Authoritative scientific studies have certified their natural functionality for decades.
Il settore degli integratori alimentari in tutto il mondo ? in continua crescita grazie anche al forte interesse sia del mondo scientifico, che degli stessi consumatori per la propria salute. The dietary supplement industry worldwide ? continuously growing thanks also to the strong interest of both the scientific world and the consumers themselves for their health.
Contrariamente alla percezione comune, l'interesse nei confronti dei prodotti per un invecchiamento sano non ? esclusivo dei Baby Boomer (persone nate tra il 1945 ed il 1964) e per i consumatori pi? anziani. Oggi le giovani generazioni, inclusi i Millennials, stanno mostrando un interesse attivo per la loro salute e pertanto stanno aumentando le vendite nel settore della nutraceutica, in particolare nelle categorie di integratori, vitamine e cure preventive. Secondo una ricerca condotta da Mintel, almeno il 70% dei giovani adulti tra i 25 e i 34 anni assumono regolarmente vitamine o minerali, rispetto all?88% circa di ultra 65enni. Le donne, inoltre, sono un altro segmento importante: ricercano nei prodotti nutraceutici soluzioni anti-invecchiamento e opzioni per il loro benessere, come quelli che alleviano i sintomi della menopausa, rafforzano le ossa o sono formulati per supportare la gravidanza. Oggigiorno tutte le generazioni cercano soluzioni per affrontare in modo sano tutte le tappe dell?et?. Contrary to common perception, interest in healthy aging products is not exclusive of Baby Boomers (people born between 1945 and 1964) and for consumers more? Senior citizens. Today the younger generations, including the Millennials, are showing an active interest in their health and therefore are increasing sales in the nutraceutical sector, especially in the categories of supplements, vitamins and preventive care. According to research conducted by Mintel, at least 70% of young adults aged 25-34 regularly take vitamins or minerals, compared with around 88% of those over 65. Women are also another important segment: they look for anti-aging solutions and options for their well-being in nutraceutical products, such as those that relieve menopausal symptoms, strengthen bones or are formulated to support pregnancy. Nowadays all generations are looking for solutions to deal with all stages of age in a healthy way.
Le suddette motivazioni ci hanno spinto a valutare un nuovo approccio all?esigenza del mondo scientifico e del consumatore finale, un'esigenza dettata da nuove tecnologie di ricerca & sviluppo, da nuovi stili di vita, e soprattutto dettata dall?interesse del consumatore ad una vita sana, pi? longeva, basata sulla nutrizione variegata e su quanto la natura in ambito alimentare e medico offre. L?unicit? della nostra invenzione ? di aver interpretato in maniera innovativa la Nutraceutica partendo da un principio differente rispetto al mercato attuale degli integratori, che a nostro giudizio ? fermo ad un concetto statico di 1 a 1 (un sintomo = un integratore), la nostra ?NUTRACEUTICA 5.0? invece si fonda su un nuovo paradigma: ?LA POLIVALENZA? (pi? disturbi = un solo rimedio). Attraverso l?utilizzo di innovativi nutraceutici, che presentano pi? di un grado di valenza, si attuer? una nuova gestione dell?individuo affetto da comorbilit? e quindi soggetto a poli-trattamenti. Il risultato ? apportare all?organismo pi? benefici naturali in un colpo solo, evitando cos? l?assunzione di molteplici integratori differenti in qualit?, tipo di estrazione e numerica quantitativa delle materie organiche utilizzate. Il rischio di interazione tra diversi integratori cresce con il numero degli integratori assunti, e potrebbe far aumentare il pericolo di sviluppare una reazione avversa nell?organismo. The aforementioned reasons led us to evaluate a new approach to the needs of the scientific world and of the final consumer, a need dictated by new research & development technologies, by new lifestyles, and above all dictated by the consumer's interest in a healthy life, more long-lived, based on varied nutrition and on what nature offers in the food and medical fields. The uniqueness of our invention? to have interpreted Nutraceuticals in an innovative way starting from a different principle than the current market of supplements, which in our opinion ? fixed to a static concept of 1 to 1 (one symptom = one supplement), our ?NUTRACEUTIC 5.0? instead it is based on a new paradigm: ?THE VERSATILITY? (more troubles = only one remedy). Through the use of innovative nutraceuticals, which have more? of a degree of valence, will it be implemented? a new management of the individual affected by comorbidity? and therefore subject to poly-treatments. The result ? make to? the organism more? natural benefits in one fell swoop, thus avoiding the assumption of multiple different supplements in quality, type of extraction and numerical quantity of the organic materials used. The risk of interactions between different supplements increases with the number of supplements taken, and could increase the risk of developing an adverse reaction in the body.
Infatti per la prima volta nel settore nutraceutico si va a coadiuvare, con un solo composto molecolare di origine naturale, non pi? solamente i sintomi ma ci si dirige direttamente all?origine del disturbo potenziando anche i processi di difesa immunitaria. Questo permetter?, allo stesso composto molecolare nutraceutico, di coprire il 70% delle quote di mercato per ambito di azione (immunostimolanti, antinfiammatori naturali, digestione/intestino/fegato, cuore/circolazione, affezioni delle vie respiratorie, sistema neurologico, antistanchezza, dolori articolari e muscolari cronici, valori glicemici, disfunzioni ormonali e multivitaminici). Dunque nel breve si andranno a sviluppare linee di ?farmaci naturali? con il suddetto composto nutraceutico, che regoleranno la risposta immunitaria dell?individuo contro diversi stati infiammatori anche cronici, rendendo il concetto di polivalenza rivoluzionario nel mercato attuale. In fact, for the first time in the nutraceutical sector we are going to assist, with a single molecular compound of natural origin, no longer? only the symptoms but we go directly to the origin of the disorder, also enhancing the processes of immune defense. This will allow the same nutraceutical molecular compound to cover 70% of the market shares by field of action (immunostimulants, natural anti-inflammatories, digestion/intestine/liver, heart/circulation, respiratory tract diseases, neurological system, anti-fatigue, pain joints and muscles, glycemic values, hormonal and multivitamin dysfunctions). Therefore, in the short term, lines of ?natural medicines? with the aforementioned nutraceutical compound, which will regulate the individual's immune response against various inflammatory states, including chronic ones, making the concept of versatility revolutionary in the current market.
OGGETTO DELL?INVENZIONE OBJECT OF THE INVENTION
La presente invenzione ha per oggetto un composto molecolare nutraceutico in forma liquida comprendente un miscela specifica di: estratti di foglie e/o semi di: Moringa Oleifera, Hibiscus, Stevia (piante officinali) con principi attivi con bassa biodisponibilit?; del flavonoide Naringenina; e delle forme principali che costituiscono il gruppo Vitaminico D. Detta invenzione pu? essere impiegata come un integratore alimentare o per una composizione molecolare nutraceutica comprendente detta composizione. The present invention relates to a nutraceutical molecular compound in liquid form comprising a specific mixture of: extracts of leaves and/or seeds of: Moringa Oleifera, Hibiscus, Stevia (officinal plants) with active ingredients with low bioavailability; of the flavonoid Naringenin; and of the main forms that make up the Vitamin D group. Said invention can? be used as a dietary supplement or for a nutraceutical molecular composition comprising said composition.
Nel dettaglio gli estratti secchi e/o liquidi delle tre piante officinali (Moringa Oleifera, Hibiscus, Stevia) contengono un ampissimo spettro di componenti bioattive, metaboliti primari e secondari. Con specifico riferimento all?ingredientistica e ai componenti dell?estratto di semi di Moringa Oleifera Lam. ai quali vanno riconosciute espressioni salutistiche riconducibili alla: regolarit? digestiva, alla fluidit? delle secrezioni bronchiali, alla regolarit? del processo di sudorazione, alla normale circolazione del sangue, come tonico del metabolismo lipidico e per l'equilibrio del peso corporeo. Tutte queste propriet?, che riflettono le evidenze scientifiche ed etnobotaniche documentate in letteratura relative alla specie, sono declinate dal Ministero della Salute nell?Allegato 1 al DM 10 agosto 2018 sulla disciplina dell?impiego negli integratori alimentari di sostanze e preparati vegetali come aggiornato con decreto del 9 gennaio 2019 e del 26 luglio 2019. Per quanto attiene all?estratto secco delle foglie di Moringa Oleifera Lam., esso si caratterizza di una spiccata funzionalit? antiossidante e quindi di fatto potenzialmente preventiva rispetto a numerosi disturbi e patologie di varia natura, principalmente su base infiammatoria come attestato da numerose pubblicazioni in merito (Yang Liu et al., 2018, e bibliografia citata nella review). Particolare attenzione ? recentemente riposta anche sulle propriet? inibitorie dell?adipogenesi, riducendo la proliferazione e sviluppo degli adipociti lasciando supporre un importante ruolo nel contesto dell?integrazione alimentare anche per il controllo dell?obesit? (Sri Renukadevi Balusamy et al., 2019). Nondimeno, e con ogni probabilit? riconducibile alle propriet? antiossidanti, ? stata provata la capacit? protettiva dell?estratto di foglie di Moringa verso il tessuto epatico esposto ad agenti tossici (es. cobalto) e verso lo stress ossidativo a carico del tessuto cardiaco esposto a co-somministrazione con farmaci antibiotici (Samah R. Khalil et al.,2020 a,b). La componente erboristica riferita a Stevia Rebaudiana Bertoni ? invece da associarsi essenzialmente alla funzionalit? dolcificante acalorica utile a migliorare la palatabilit? del prodotto. In detail, the dry and/or liquid extracts of the three medicinal plants (Moringa Oleifera, Hibiscus, Stevia) contain a very broad spectrum of bioactive components, primary and secondary metabolites. With specific reference to the ingredients and components of the Moringa Oleifera Lam seed extract. to which health expressions attributable to: regularity? digestive, to the fluidity? of bronchial secretions, the regularity? of the sweating process, to normal blood circulation, as a tonic of lipid metabolism and for the balance of body weight. All these properties, which reflect the scientific and ethnobotanical evidence documented in the literature relating to the species, are set out by the Ministry of Health in Annex 1 to the Ministerial Decree of August 10, 2018 on the regulation of the use of plant substances and preparations in food supplements as updated with decree of 9 January 2019 and 26 July 2019. As regards the dry extract of the leaves of Moringa Oleifera Lam., it is characterized by a marked functionality antioxidant and therefore in fact potentially preventive with respect to numerous disorders and pathologies of various kinds, mainly on an inflammatory basis as attested by numerous publications in this regard (Yang Liu et al., 2018, and bibliography cited in the review). Particular attention? recently placed also on the properties? inhibitors of adipogenesis, reducing the proliferation and development of adipocytes suggesting an important role in the context of food integration also for the control of obesity? (Sri Renukadevi Balusamy et al., 2019). Nonetheless, and in all probability? attributable to the properties? antioxidants, ? been tested the ability? protective effect of Moringa leaf extract against liver tissue exposed to toxic agents (e.g. cobalt) and against oxidative stress on cardiac tissue exposed to co-administration with antibiotic drugs (Samah R. Khalil et al., 2020 a ,b). The herbal component referred to Stevia Rebaudiana Bertoni ? instead to be associated essentially with the functionality? non-caloric sweetener useful to improve palatability of the product.
L?Hibiscus sabdariffa L. fiori svolge un'azione antiossidante, supporta la regolarit? della pressione arteriosa, aiuta la regolarit? del transito intestinale e favorisce il drenaggio dei liquidi corporei anche grazie alla promozione della funzionalit? delle vie urinarie, come declinato dal Ministero della Salute nell?Allegato 1 al DM 10 agosto 2018 sulla disciplina dell?impiego negli integratori alimentari di sostanze e preparati vegetali come aggiornato con decreto del 9 gennaio 2019 e del 26 luglio 2019, ed ampiamente documentato dalla corposa letteratura scientifica le cui evidenze possono essere riassumibili in significative reviews recenti (Laskar and Mazumder, 2020; Riaza and Chopra, 2018). Hibiscus sabdariffa L. flowers has an antioxidant action, supports the regularity of blood pressure, helps the regularity? of intestinal transit and promotes the drainage of body fluids thanks to the promotion of functionality? of the urinary tract, as set out by the Ministry of Health in Annex 1 to the Ministerial Decree of 10 August 2018 on the regulation of the use of plant substances and preparations in food supplements as updated with the decree of 9 January 2019 and 26 July 2019, and amply documented by the substantial scientific literature whose evidence can be summarized in significant recent reviews (Laskar and Mazumder, 2020; Riaza and Chopra, 2018).
Nella presente invenzione, la scelta dell?addizione di Naringenina e di vitamina D determina l?ottenimento di un composto nutraceutico fortificato rispetto alle gi? descritte ed importanti propriet? antiossidanti degli estratti delle tre piante, ulteriormente implementato rispetto alle caratteristiche funzionali che accomunano i due soggetti chimici (Naringenina e vitamina D), ovvero, nello specifico, le propriet? antinfiammatorie ed immunomodulanti. La ingredientistica riflette dunque un?espressione inedita di associazione degli estratti naturali e chimici. Gli aspetti funzionali e salutistici che valorizzano la Naringenina come sono ampiamente documentati da una nutrita letteratura che ne disegna diverse propriet? biologiche, ampiamente riassunte e documentate da numerose review che raccolgono la summa delle ricerche sviluppate su questo composto. Complessivamente tutte le ricerche che hanno avuto come soggetto le bioattivit? della Naringenina sono focalizzate sulle spiccate propriet? antiossidanti che si traducono spesso in meccanismi antinfiammatori a carico di diversi distretti, e causa di diversi disturbi e patologie. Con specifico riferimento alle dismetabolie, ad esempio, ? stato ampiamente dimostrato il ruolo della Naringenina come agente protettivo verso gli stress ossidativi, le iperlipidemie, l?obesit?, il diabete, processi infiammatori in genere ed espressioni di tossicit? riflesse su diversi organi e distretti (Karim et al., 2018; Joshi et al., 2018). Tali importanti propriet? si sviluppano attraverso una espressione multipla caratterizzata dalle caratteristiche della Naringenina di agire sia come radical scavenger sia come agente stimolante l?attivit? di enzimi endogeni antiossidanti (Karim et al., 2018; Zaidun et al., 2018). Altre importanti evidenze delle propriet? salutistiche della Naringenina correlate all?azione antiossidante sono emerse in riferimento a studi sulla sua biodisponibilit?, farmacocinetica e modalit? d?impiego evidenziando importanti propriet? potenzialmente preventive di cancro, diabete, stati infiammatori cronici (ad es. in relazione a malattie autoimmuni), problematiche epatiche, cardiovascolari e disordini neurologici (Chin et al., 2020; Lutu et al., 2019; Joshi et al., 2018; Kapoor and Kakkar, 2014). Proprio in relazione ad aspetti immunitari, si fanno sempre pi? significative le evidenze di una interazione tra Naringenina e funzionalit? del sistema immunitario, con particolare riferimento all? attenuazione di sintomatologie infiammatorie, anche correlate a sindromi autoimmuni (Wang et al., 2018; Zeng et al., 2018). Non sono note espressioni tossicologiche che ne controindicano l?impiego, fatto salvo evidenze relative all?inibizione di sistemi enzimatici epatici per cui la concomitante assunzione di farmaci ne aumenterebbe la biodisponibilit? e di conseguenza il rischio di effetti collaterali. Va comunque sottolineato che tale espressione di inibizione di enzimi microsomiali ? stata osservata innanzitutto sull?estratto di pompelmo in toto e pare piuttosto l?espressione della bioattivit? della forma glicosilata (Naringina), e non della Naringenina (Ajazuddin et a., 2014; Dudhatra et al., 2012). In the present invention, the choice of the addition of Naringenin and vitamin D determines the obtainment of a nutraceutical compound fortified with respect to the already described and important properties? antioxidants of the extracts of the three plants, further implemented with respect to the functional characteristics that unite the two chemical subjects (Naringenin and vitamin D), or, specifically, the properties anti-inflammatory and immunomodulatory. The ingredients thus reflect an unprecedented expression of association of natural and chemical extracts. The functional and health aspects that enhance the Naringenina as are widely documented by a large literature that draws various properties? biological, amply summarized and documented by numerous reviews that collect the sum of the researches developed on this compound. Altogether all the researches that have had as subject the bioactivities? of Naringenina are focused on the marked properties? antioxidants which often translate into anti-inflammatory mechanisms affecting different districts, and causing various disorders and pathologies. With specific reference to metabolic disorders, for example, ? The role of Naringenin as a protective agent against oxidative stress, hyperlipidemia, obesity, diabetes, inflammatory processes in general and expressions of toxicity has been amply demonstrated. reflected on different bodies and districts (Karim et al., 2018; Joshi et al., 2018). These important properties develop through a multiple expression characterized by the characteristics of Naringenin to act both as a radical scavenger and as an agent stimulating the activity? of endogenous antioxidant enzymes (Karim et al., 2018; Zaidun et al., 2018). Other important evidence of the properties? health benefits of Naringenin related to the antioxidant action have emerged in reference to studies on its bioavailability, pharmacokinetics and modality? of use highlighting important properties? potentially preventive of cancer, diabetes, chronic inflammatory states (e.g. in relation to autoimmune diseases), liver problems, cardiovascular and neurological disorders (Chin et al., 2020; Lutu et al., 2019; Joshi et al., 2018; Kapoor and Kakkar, 2014). Precisely in relation to immune aspects, they are becoming more and more? significant evidence of an interaction between Naringenin and functionality? of the immune system, with particular reference to the attenuation of inflammatory symptoms, also related to autoimmune syndromes (Wang et al., 2018; Zeng et al., 2018). There are no known toxicological expressions that contraindicate its use, except for evidence relating to the inhibition of hepatic enzymatic systems for which the concomitant intake of drugs would increase their bioavailability. and consequently the risk of side effects. However, it should be emphasized that this expression of inhibition of microsomal enzymes ? was first observed on the grapefruit extract as a whole and it seems rather the expression of the bioactivity? of the glycosylated form (Naringin), and not of Naringenin (Ajazuddin et a., 2014; Dudhatra et al., 2012).
La vitamina D assunta con la dieta ? una miscela di sostanze liposolubili (D1: ergocalciferolo e lumisterolo; D2: ergocalciferolo; D3: colecalciferolo; D4: didroergocalciferolo; D5: sitocalciferolo). I due composti pi? rilevanti dal punto di vista salutistico sono l?ergocalciferolo, o vitamina D2, di derivazione prevalentemente vegetale, ed il colecalciferolo, o vitamina D3, di provenienza prevalentemente animale. La vitamina D assunta attraverso la dieta ? presente comunque in forme biologicamente non attive. Una volta assorbita dall?organismo subisce processi di idrossilazione che la convertono in calcitriolo, la forma bioattiva. La vitamina D ? prodotta anche endogenamente dal nostro organismo per conversione indotta dall?esposizione alla luce solare del 7- deidro-colesterolo in colecalciferolo, bioattivo, e in lumisterolo e tachisterolo, due composti biologicamente invece non attivi. Secondo la Commission Regulation (EU) 432/2012 del 16/05/2012, la vitamina D ha un ruolo nel processo di divisione cellulare, contribuisce alla normale funzione del sistema immunitario, al normale assorbimento/utilizzo di calcio e fosforo, al mantenimento di normali livelli di calcio nel sangue, al mantenimento della salubrit? dell?arcata dentale, dello sviluppo e corretta funzionalit? dello scheletro e della normale funzionalit? muscolare. Particolarmente interessante ? il ruolo della vitamina D nella corretta funzionalit? del sistema immunitario che la rende un soggetto funzionalmente utile in prodotti destinati alla prevenzione di processi infiammatori anche cronici (Holik, 2006; Norman and Henry, 2006), nonch? alla riduzione di sintomi ad essi correlati, tipici ad esempio di malattie autoimmuni e alla loro prevenzione (Illescas-Montes et al., 2019; Murdaca et al., 2019). La prevenzione di processi infiammatori in genere ? infatti una delle fondamentali basi per la prevenzione di numerosissimi disturbi e patologie, dal cancro, a dismetabolie di vario genere, a malattie autoimmuni, ecc. Infine, il ben noto ruolo della vitamina D nel favorire l'assorbimento del calcio a livello intestinale e nel mantenere adeguate le concentrazioni sieriche di calcio e fosforo, consente la normale mineralizzazione delle ossa favorendo la corretta crescita e prevenendo problematiche come l?osteoporosi, e favorendo la corretta funzionalit? muscolare prevenendo la tetania ipocalcemica (Cranney et al., 2007). Vitamin D taken in the diet? a mixture of fat-soluble substances (D1: ergocalciferol and lumisterol; D2: ergocalciferol; D3: colecalciferol; D4: didroergocalciferol; D5: sitocalciferol). The two compounds pi? relevant from a health point of view are ergocalciferol, or vitamin D2, mainly of vegetable origin, and colecalciferol, or vitamin D3, of mainly animal origin. Vitamin D taken through the diet? however, it is present in biologically inactive forms. Once absorbed by the body, it undergoes hydroxylation processes which convert it into calcitriol, the bioactive form. Vitamin D? also produced endogenously by our body by conversion induced by exposure to sunlight of 7-dehydro-cholesterol into bioactive cholecalciferol, and into lumisterol and tachysterol, two biologically inactive compounds. According to the Commission Regulation (EU) 432/2012 of 16/05/2012, vitamin D has a role in the cell division process, contributes to the normal function of the immune system, to the normal absorption/utilisation of calcium and phosphorus, to the normal levels of calcium in the blood, the maintenance of health? of? dental arch, development and correct functionality? of the skeleton and normal functionality? muscle. Particularly interesting? the role of vitamin D in proper function? of the immune system which makes it a functionally useful subject in products intended for the prevention of even chronic inflammatory processes (Holik, 2006; Norman and Henry, 2006), as well as the reduction of symptoms related to them, typical for example of autoimmune diseases and their prevention (Illescas-Montes et al., 2019; Murdaca et al., 2019). The prevention of inflammatory processes in general? in fact one of the fundamental bases for the prevention of numerous ailments and pathologies, from cancer, to metabolic disorders of various kinds, to autoimmune diseases, etc. Finally, the well-known role of vitamin D in promoting the absorption of calcium in the intestine and in maintaining adequate serum concentrations of calcium and phosphorus, allows normal bone mineralization, promoting correct growth and preventing problems such as osteoporosis, and favoring the correct functionality? muscle by preventing hypocalcemic tetany (Cranney et al., 2007).
In relazione a quanto sopra riportato, l?innovativa miscela comprende un estratto di Moringa Semi titolato ad almeno il 60% di proteine, la cui percentuale in peso pu? variare tra lo 0,1% ed l?1% sul peso totale della soluzione; un estratto di Moringa foglie D/E 4:1, la cui percentuale in peso pu? variare tra l?1% ed il 1,5% sul peso totale della soluzione; un estratto secco Hibiscus fiori D/E 4:1, la cui percentuale in peso pu? variare tra l?1% ed il 1,5% sul peso totale della soluzione; Glicosidi da Stevia foglie, la cui percentuale in peso pu? variare tra lo 0,04% e lo 0,07% sul peso totale della soluzione; il flavonoide specificamente titolato in Naringenina, la cui percentuale in peso pu? variare tra lo 0,04% e lo 0,20% sul peso totale della soluzione; la Vitamina D, la cui percentuale in peso pu? variare tra lo 0,04% e lo 0,20% sul peso totale della soluzione. Le restanti percentuali in peso, che comprendono gli eccipienti e conservanti, possono variare sul peso totale della soluzione come di seguito: Glicerina tra il 6% e il 10%; Sodio benzoato tra il 0,05% e il 0,15%; Potassio sorbato tra il 0,05% e il 0,15%; Aroma tra il 0,01 e il 0,1% Acido citrico tra il 0,01% al 0,1%; Acqua tra l?87% e il 94%. In relation to the above, the innovative blend includes a Moringa Semi extract titrated to contain at least 60% protein, the percentage of which by weight can vary between 0.1% and 1% on the total weight of the solution; an extract of Moringa leaves D / E 4: 1, whose percentage by weight can? vary between 1% and 1.5% on the total weight of the solution; a dry extract Hibiscus flowers D / E 4: 1, whose percentage by weight can? vary between 1% and 1.5% on the total weight of the solution; Glycosides from Stevia leaves, whose percentage by weight can vary between 0.04% and 0.07% on the total weight of the solution; the flavonoid specifically titrated in Naringenina, whose percentage by weight can? vary between 0.04% and 0.20% on the total weight of the solution; Vitamin D, whose percentage by weight can? vary between 0.04% and 0.20% of the total weight of the solution. The remaining percentages by weight, which include the excipients and preservatives, can vary on the total weight of the solution as follows: Glycerin between 6% and 10%; Sodium benzoate between 0.05% and 0.15%; Potassium sorbate between 0.05% and 0.15%; Aroma between 0.01 and 0.1% Citric acid between 0.01% and 0.1%; Water between 87% and 94%.
DESCRIZIONE DEL PROCESSO DI PREPARAZIONE PREFERITO DESCRIPTION OF THE PREFERRED PREPARATION PROCESS
Un ulteriore oggetto della presente invenzione ? un processo per la preparazione della composizione nutraceutica, contenente: gli estratti liquidi e/o estratti semi-liquidi e/o estratti secchi di tre piante officinali quali: Moringa Oleifera, Hibiscus sabdariffa e Stevia rebaudiana; le forme principali che costituiscono i gruppi Vitaminici D; un flavonoide detto Naringenina. Tale processo comprende nel dettaglio diversi passaggi: a) pesatura di tutti i componenti; b) miscelazione a caldo, nel dettaglio, dei seguenti componenti per ogni 500ml di soluzione: principio attivo con bassa biodisponibilit? di un estratto di Moringa Semi titolato ad almeno il 60% di proteine in quantit? da 0,5g a 5g; di un estratto di Moringa foglie D/E 4:1, in quantit? da 5g a 7,5g; di una quantit? di estratto secco Hibiscus fiori D/E 4:1, tra 5g e 7,5g; di una quantit? di Glicosidi da Stevia foglie tra 0,20g e 0,35g; del flavonoide specificamente titolato in Naringenina in quantit? da 0,20g e 1g; della Vitamina D in quantit? da 0,20g a 1g. Inoltre nella miscelazione a caldo vengono inseriti gli eccipienti e conservanti, le cui quantit? possono variare come di seguito: Glicerina tra 30g e 50g; Sodio benzoato tra 0,25g e 0,75g; Potassio sorbato tra 0,25g e 0,75g; Aroma tra 0,05g e 0,5g; Acido citrico tra 0,05g e 0,5g; Acqua tra 435g e 470g. Il pH ? compreso tra 300 e 5,00; c) dopo una fase di decantazione e raffreddamento viene infine conservata e imbottigliata nell?apposito flacone in PET da 500,00 ml. Costituisce un ulteriore oggetto della presente invenzione, l?uso della composizione nutraceutica sopra descritta come integratore alimentare in formulazioni liquide orali. A further object of the present invention ? a process for the preparation of the nutraceutical composition, containing: the liquid extracts and/or semi-liquid extracts and/or dry extracts of three medicinal plants such as: Moringa Oleifera, Hibiscus sabdariffa and Stevia rebaudiana; the main forms that make up the Vitamin D groups; a flavonoid called Naringenin. This process includes in detail several steps: a) weighing of all the components; b) hot mixing, in detail, of the following components for each 500ml of solution: active ingredient with low bioavailability? of a Moringa Semi extract titrated to at least 60% protein in quantity? from 0.5g to 5g; of an extract of Moringa leaves D / E 4: 1, in quantity? from 5g to 7.5g; of a quantity? of dry extract Hibiscus flowers D/E 4:1, between 5g and 7.5g; of a quantity? of Glycosides from Stevia leaves between 0.20g and 0.35g; of the flavonoid specifically titrated in Naringenin in quantity? from 0.20g and 1g; of Vitamin D in quantity? from 0.20g to 1g. In addition, excipients and preservatives are added to the hot mixing, the quantities of which are may vary as follows: Glycerin between 30g and 50g; Sodium benzoate between 0.25g and 0.75g; Potassium sorbate between 0.25g and 0.75g; Flavor between 0.05g and 0.5g; Citric acid between 0.05g and 0.5g; Water between 435g and 470g. The pH? between 300 and 5.00; c) after a phase of decantation and cooling, it is finally stored and bottled in the appropriate 500.00 ml PET bottle. A further object of the present invention is the use of the nutraceutical composition described above as a food supplement in oral liquid formulations.
CONCLUSIONI CONCLUSIONS
La composizione nutraceutica in oggetto si caratterizza nella sua unicit? con espressioni funzionali polivalenti che bene si adattano alla prevenzione e al miglioramento di molteplici disturbi infiammatori di varia natura. Infine, ad arricchire l?espressione della composizione nutraceutica destinata ad un uso umano, non trascurabile ? la possibile ricaduta nella supplementazione veterinaria, sia per gli animali da reddito sia per quelli da affezione (Falowo et al., 2018; Valdivi?-Navarro et al., 2020), come integratore in stato solido. The nutraceutical composition in question is characterized in its uniqueness? with multipurpose functional expressions that are well suited to the prevention and improvement of multiple inflammatory disorders of various kinds. Finally, to enrich the expression of the nutraceutical composition intended for human use, not negligible? the possible fallout in veterinary supplementation, both for livestock and pets (Falowo et al., 2018; Valdivi?-Navarro et al., 2020), as a solid state supplement.
Claims (10)
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| JP2005042221A (en) * | 2003-07-23 | 2005-02-17 | Kazuyoshi Okubo | Active oxygen free radical-eliminating agent containing silver-containing complex protein |
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| EP3698642A1 (en) * | 2019-02-21 | 2020-08-26 | Interquim, S.A. | Flavonoids and animal health and performance |
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