IT201900010806A1 - COMPOSITION CONTAINING SEQUOIA EXTRACT IN PUMPKIN OIL TO MAINTAIN PROSTATE FUNCTIONALITY - Google Patents
COMPOSITION CONTAINING SEQUOIA EXTRACT IN PUMPKIN OIL TO MAINTAIN PROSTATE FUNCTIONALITY Download PDFInfo
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
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- 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
- A61K36/13—Coniferophyta (gymnosperms)
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- 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)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/324—Boswellia, e.g. frankincense
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- 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)
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- A61K36/42—Cucurbitaceae (Cucumber family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
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- 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)
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- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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Description
Titolo: COMPOSIZIONE CONTENENTE ESTRATTO DI SEQUOIA IN OLIO DI ZUCCA PER IL MANTENIMENTO DELLA FUNZIONALITÀ DELLA PROSTATA Title: COMPOSITION CONTAINING SEQUOIA EXTRACT IN PUMPKIN OIL TO MAINTAIN PROSTATE FUNCTIONALITY
DESCRIZIONE DESCRIPTION
CAMPO DELL’INVENZIONE FIELD OF THE INVENTION
La presente invenzione riguarda una composizione, un metodo per la sua produzione ed un metodo di uso, in cui la composizione aiuta efficacemente a mantenere la funzionalità della prostata. La composizione comprende una miscela precisa di agenti altamente attivi, compresi: The present invention relates to a composition, a method for its production and a method of use, in which the composition effectively helps to maintain the functionality of the prostate. The composition includes a precise blend of highly active agents, including:
estratto di foglie di sequoia in olio di semi di zucca microincapsulato, sequoia leaf extract in microencapsulated pumpkin seed oil,
estratto di caffè verde contenente acidi clorogenici, chitosano. green coffee extract containing chlorogenic acids, chitosan.
SFONDO DELL’INVENZIONE BACKGROUND OF THE INVENTION
Un prodotto per il mantenimento delle funzionalità della prostata è un prodotto che ha la caratteristica di evitare l'insorgenza di disturbi della prostata quali iperplasia, infiammazione ed infezione prostatica. A product for the maintenance of prostate functions is a product that has the characteristic of avoiding the onset of prostate disorders such as hyperplasia, inflammation and prostatic infection.
L’iperplasia prostatica benigna (IPB) è caratterizzata dall'aumento di volume della ghiandola prostatica. Le cause non sono del tutto chiarite, ma sono state osservate correlazioni tra l'insorgenza di IPB e fattori quali: Benign prostatic hyperplasia (BPH) is characterized by an increase in the volume of the prostate gland. The causes are not fully understood, but correlations have been observed between the onset of BPH and factors such as:
- livelli ematici elevati di estrogeni; - elevated blood levels of estrogen;
- livelli ematici ridotti di testosterone libero; - reduced blood levels of free testosterone;
- livelli ematici elevati di diidrotestosterone; - elevated blood levels of dihydrotestosterone;
- età avanzata; - old age;
- ereditarietà; - inheritance;
- stile di vita, per esempio le abitudini al fumo e al consumo di alcol, e la sedentarietà. - lifestyle, for example smoking and alcohol consumption habits, and a sedentary lifestyle.
L’infiammazione prostatica è causata da: Prostate inflammation is caused by:
- infezioni batteriche; - bacterial infections;
- stili di vita come il fumo, il consumo di alcol e la sedentarietà; - lifestyles such as smoking, alcohol consumption and a sedentary lifestyle;
- sollecitazione muscolare eccessiva o troppo ridotta della zona prostatica. - excessive or too little muscle stress in the prostate area.
L’infezione prostatica è causata da: Prostate infection is caused by:
- colonizzazione da parte di microorganismi patogeni che risalgono l'uretra e si localizzano a livello prostatico; - colonization by pathogenic microorganisms that go up the urethra and are localized in the prostate;
- colonizzazione da parte di microorganismi patogeni localizzati a livellorettale che si diffondonoversola prostata; - colonization by pathogenic microorganisms localized at the rectal level that spread through the prostate;
- rapporti sessuali. - sexual intercourse.
Allo scopo di ottenere prodotti per il mantenimento della funzionalità della prostata, sono state sviluppate diverse sostanze, dotate di effetti e meccanismi d’azione diversi, che possono agire sulle numerose cause che danno origine all'iperplasia, all'infiammazione e all'infezione prostatica. Infatti, tali principi attivi possono esplicare effetti diversi quali: In order to obtain products for the maintenance of prostate functionality, various substances have been developed, with different effects and mechanisms of action, which can act on the numerous causes that give rise to hyperplasia, inflammation and prostatic infection. . In fact, these active ingredients can have different effects such as:
• effetto antiinfiammatorio; • anti-inflammatory effect;
• effetto antimicrobico; • antimicrobial effect;
• effetto antiiperplasia prostatica: tale azione è mediata dall'attività inibitoria nei confronti dell'enzima target 5-alfareduttasi. La 5-alfa-reduttasi (nota anche come 3-osso-5-alfasteroide 4-deidrogenasi) converte il testosterone in diidrotestosterone. Quest'ultimo è un ormone che stimola e controlla lo sviluppo ed il mantenimento delle caratteristiche maschili; • prostatic antihyperplasia effect: this action is mediated by the inhibitory activity against the target enzyme 5-alpha reductase. 5-alpha-reductase (also known as 3-oxo-5-alpha-asteroid 4-dehydrogenase) converts testosterone into dihydrotestosterone. The latter is a hormone that stimulates and controls the development and maintenance of male characteristics;
• effetto antiproliferativo su cellule tumorali della prostata; • antiproliferative effect on prostate cancer cells;
• effetto di miglioramento della funzione erettile. • effect of improving erectile function.
Diverse sostanze o prodotti mostrano proprietà utili al mantenimento della funzionalità della prostata, esplicando uno o più dei suddetti effetti. Inoltre, da prodotti presenti in commercio o dalla letteratura scientifica e brevettuale, sono noti numerosi tentativi di associare varie sostanze per cercare di ottenere composizioni efficaci per il mantenimento della funzionalità della prostata. Several substances or products show properties useful for maintaining the functionality of the prostate, exerting one or more of the aforementioned effects. Furthermore, numerous attempts to combine various substances in order to obtain effective compositions for maintaining the functionality of the prostate are known from products available on the market or from the scientific and patent literature.
Per esempio, è noto che l’estratto di foglie di sequoia contiene, tra i vari fitocomponenti lipofili, diversi terpeni che sono particolarmente abbondanti nell'olio delle foglie. I fitocostituenti principali sono α-pinene (45%) ed elemicina (22%). Altri composti quantitativamente importanti sono mircene (6%), metileugenolo (4%) e α-terpineolo (3.0%) [Jerkovic I, Mastelic J, Milos M. Chemical Composition of the Essential Oil of Sequoiadendron giganteum(Lindl.) Buch H. cultivated in Croatia. J. Essent. Oil Res. 2003;15:36-38 (gennaio/febbraio 2003)]. Molti di questi terpeni hanno effetti antiproliferativi su cellule tumorali della prostata [Zhao Y, Chen R, Wang Y, Yang Y. α-Pinene Inhibits Human Prostate Cancer Growth in a Mouse Xenograft Model. Chemotherapy. 2018;63(1):1-7. doi: 10.1159/000479863]. Inoltre, è stato mostrato che l'α-pinene in modelli animali è sicuro fino a dosaggi di 25-100 mg/kg. Nell'uomo, dosaggi di 10 mg sono stati oggetto di uno studio farmacocinetico. I soggetti non hanno mostrato alcun effetto avverso [Schmidt L, Göen T. Arch. Toxicol. For example, it is known that the sequoia leaf extract contains, among the various lipophilic phytocomponents, several terpenes that are particularly abundant in the oil of the leaves. The main phytoconstituents are α-pinene (45%) and elemicin (22%). Other quantitatively important compounds are myrcene (6%), methylugenol (4%) and α-terpineol (3.0%) [Jerkovic I, Mastelic J, Milos M. Chemical Composition of the Essential Oil of Sequoiadendron giganteum (Lindl.) Buch H. cultivated in Croatia. J. Essent. Oil Res. 2003; 15: 36-38 (January / February 2003)]. Many of these terpenes have antiproliferative effects on prostate cancer cells [Zhao Y, Chen R, Wang Y, Yang Y. α-Pinene Inhibits Human Prostate Cancer Growth in a Mouse Xenograft Model. Chemotherapy. 2018; 63 (1): 1-7. doi: 10.1159 / 000479863]. Furthermore, α-pinene in animal models has been shown to be safe up to dosages of 25-100 mg / kg. In humans, dosages of 10 mg have been the subject of a pharmacokinetic study. The subjects showed no adverse effects [Schmidt L, Göen T. Arch. Toxicol.
2017;91(2):677-687. doi: 10.1007/s00204-015-1656-9. Human metabolism of α-pinene and metabolite kinetics after oral administration; Yang H, Woo J, Pae AN, UmMY, Cho NC, Park KD, Yoon M, KimJ, Lee CJ, Cho S. Mol. Pharmacol. 90:530–539, 2016. a-Pinene, a Major Constituent of Pine Tree Oils, Enhances Non-Rapid Eye Movement Sleep in Mice through GABAA-benzodiazepine Receptors]. 2017; 91 (2): 677-687. doi: 10.1007 / s00204-015-1656-9. Human metabolism of α-pinene and metabolite kinetics after oral administration; Yang H, Woo J, Pae AN, UmMY, Cho NC, Park KD, Yoon M, KimJ, Lee CJ, Cho S. Mol. Pharmacol. 90: 530-539, 2016. a-Pinene, a Major Constituent of Pine Tree Oils, Enhances Non-Rapid Eye Movement Sleep in Mice through GABAA-benzodiazepine Receptors].
L’olio di semi di zucca (Cucurbita sp.) è un olio particolarmente ricco di acido oleico (30-41%) e linoleico (42-52%). I semi di zucca possono essere utilizzati per il sollievo dei sintomi del tratto urinario inferiore correlati a iperplasia prostatica benigna o correlati a vescica iperattiva. L'olio di semi di zucca estratto dalla Cucurbita maxima migliora infatti i disturbi urinari insoggetti affetti da vescicaiperattiva. Quando somministrato come unico ingrediente, i dosaggi tipici dell'olio di semi di zucca sonodi 1-1,2 g, 3volte al giorno[EMA, Committee on Herbal Medicinal Products: Assessment report on Cucurbita pepo L., semen (PDF), su ema.europa.eu; Nishimura M, Ohkawara T, Sato H, Takeda H, Nishihira J. Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder. J. Tradit. Complement. Med. 2014;4(1):72-4. doi: 10.4103/2225-4110.124355]. Pumpkin seed oil (Cucurbita sp.) Is an oil particularly rich in oleic (30-41%) and linoleic (42-52%) acid. Pumpkin seeds can be used for the relief of lower urinary tract symptoms related to benign prostatic hyperplasia or related to overactive bladder. Pumpkin seed oil extracted from Cucurbita maxima improves urinary disorders in subjects suffering from overactive bladder. When given as a sole ingredient, typical dosages of pumpkin seed oil are 1-1.2 g, 3 times per day [EMA, Committee on Herbal Medicinal Products: Assessment report on Cucurbita pepo L., semen (PDF), su ema.europa.eu; Nishimura M, Ohkawara T, Sato H, Takeda H, Nishihira J. Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder. J. Tradit. Complement. Med. 2014; 4 (1): 72-4. doi: 10.4103 / 2225-4110.124355].
Gli acidi clorogenici contenuti nel caffè verde sono dei polifenoli e mostrano attività anti-iperplasia prostatica benigna [Huang Y, Chen H, Zhou X, Wu X, Hu E, Jiang Z. Inhibition effects of chlorogenic acid on benign prostatic hyperplasia in mice. Eur. J. Pharmacol. 2017;809:191-195. doi: 10.1016/j.ejphar.2017.04.017]. I dosaggi riportati sono da 1,6 mg/kg a 3,2 mg/kg nel ratto che corrispondono, per un uomo di 70 kg, a 112-224 mg. The chlorogenic acids contained in green coffee are polyphenols and show anti-benign prostatic hyperplasia [Huang Y, Chen H, Zhou X, Wu X, Hu E, Jiang Z. Inhibition effects of chlorogenic acid on benign prostatic hyperplasia in mice. Eur. J. Pharmacol. 2017; 809: 191-195. doi: 10.1016 / j.ejphar.2017.04.017]. The dosages reported are from 1.6 mg / kg to 3.2 mg / kg in rats which correspond to 112-224 mg for a 70 kg man.
Il chitosano ha l a seguente struttura: Chitosan has the following structure:
È un polisaccaride lineare composto da D-glucosamina e N-acetil-D-glucosamina, legate tramite legami β(1-4). Il chitosano e suoi derivati aumentano l'assorbimento intestinale, e quindi la biodisponibilità, specialmente di macromolecole idrofile [Thanou M, Verhoef JC, Junginger HE. Chitosan and its derivatives as intestinal absorption enhancers. Adv. Drug. Deliv. Rev. 2001;50 Suppl. 1:S91-101] tra cui anche catechine/polifenoli [Dube A, Nicolazzo JA, Larson I. Chitosan nanoparticles enhance the intestinal absorption of the green tea catechins (+)-catechin and (−)-epigallocatechingallate. Eur. J. Pharm. Sci. 2010;41(2):219-225]. Generalmente i suoi dosaggi sono pari a 1/4 del dosaggio dei polifenoli totali ad esso associati. It is a linear polysaccharide composed of D-glucosamine and N-acetyl-D-glucosamine, linked via β (1-4) bonds. Chitosan and its derivatives increase intestinal absorption, and therefore bioavailability, especially of hydrophilic macromolecules [Thanou M, Verhoef JC, Junginger HE. Chitosan and its derivatives as intestinal absorption enhancers. Adv. Drug. Deliv. Rev. 2001; 50 Suppl. 1: S91-101] including catechins / polyphenols [Dube A, Nicolazzo JA, Larson I. Chitosan nanoparticles enhance the intestinal absorption of the green tea catechins (+) - catechin and (-) - epigallocatechingallate. Eur. J. Pharm. Sci. 2010; 41 (2): 219-225]. Generally its dosages are equal to 1/4 of the dosage of the total polyphenols associated with it.
Nonostante, come dettosopra, sianonoti (daprodotti presenti in commercio o dalla letteratura scientifica e brevettuale) numerosi tentativi di associare varie sostanze per cercare di ottenere composizioni efficaci per il mantenimento della funzionalità della prostata, è ancora sentita l’esigenza di riuscire a combinare diverse sostanze con proprietà differenti, in proporzioni tali da esibire effetti sinergici in termini di efficacia per il mantenimento delle funzionalità della prostata e allo stesso tempo in grado di essere ben tollerate. Although, as mentioned above, there are known (from products on the market or from scientific and patent literature) numerous attempts to combine various substances to try to obtain effective compositions for maintaining the functionality of the prostate, the need is still felt to be able to combine different substances with different properties, in such proportions as to exhibit synergistic effects in terms of efficacy for maintaining the functionality of the prostate and at the same time able to be well tolerated.
Infatti, ci sono vari problemi tecnici che una composizione ideale dovrebbe risolvere. In particolare, tali composizioni dovrebbero: In fact, there are various technical problems that an ideal composition should solve. In particular, such compositions should:
- essere efficaci, - avere una buona biodisponibilità dei principi attivi, - essere ben tollerate, - be effective, - have good bioavailability of the active ingredients, - be well tolerated,
- mostrare bassissima tossicità, - essere adatte anche per usi prolungati e ripetuti, - essere di facile somministrazione, per esempio in forma di capsule o di compresse, - avere un odore e un sapore non sgradevoli, - essere preferibilmente realizzate coningredienti naturali, - complessivamente quindi dovrebbero avere una buona compliance da parte dei soggetti che le assumono, per esempio fornendo una dose efficace di numerosi principi attivi che agiscono in sinergia, senza che la forma di somministrazione per via orale (per esempio compressa o capsula) abbia grosse dimensioni (per esempio dovrebbe avere un peso inferiore a 1,5 g), e senza che siano richieste numerose somministrazioni giornaliere, preferibilmente cioè siano somministrabili una sola volta al giorno. - show very low toxicity, - be suitable also for prolonged and repeated use, - be easy to administer, for example in capsule or tablet form, - have a non-unpleasant smell and taste, - be preferably made with natural ingredients, - overall therefore they should have good compliance on the part of the subjects who take them, for example by providing an effective dose of numerous active ingredients that act in synergy, without the form of oral administration (for example tablet or capsule) having large dimensions (for example should have a weight of less than 1.5 g), and without requiring numerous daily administrations, that is, preferably they can be administered only once a day.
È una caratteristica delle presenti composizioni contenere solo una quantità relativamente piccola di additivi e/o eccipienti, dato il contenuto elevato di principi attivi. Questo permette la produzione di forme di dosaggio unitario fisicamente piccole. La quantità totale di additivi e/o eccipienti in un dato dosaggio unitario può essere circa il 70% in peso o inferiore in base al peso totale della composizione, più in particolare circa il 60% o inferiore. Preferibilmente, l’additivo contenuto è nell’intervallo circa dal 20%al 60% in peso, più in particolare l’additivo contenuto varia da circa il 30%a circa il 55%in peso. It is a characteristic of the present compositions to contain only a relatively small amount of additives and / or excipients, given the high content of active ingredients. This allows for the production of physically small unit dosage forms. The total amount of additives and / or excipients in a given unit dosage may be about 70% by weight or less based on the total weight of the composition, more particularly about 60% or less. Preferably, the additive contained is in the range from about 20% to 60% by weight, more particularly the additive contained varies from about 30% to about 55% by weight.
SOMMARIO DELL’INVENZIONE SUMMARY OF THE INVENTION
Lo scopo di cui sopra è stato raggiunto mediante una composizione comprendente una combinazione unica di ingredienti compresi: The above purpose was achieved by a composition comprising a unique combination of ingredients including:
estratto di foglie di sequoia in olio di semi di zucca microincapsulato, sequoia leaf extract in microencapsulated pumpkin seed oil,
estratto di caffè verde contenente acidi clorogenici, chitosano. green coffee extract containing chlorogenic acids, chitosan.
Gli inventori della presente invenzione hanno sorprendentemente trovato che i seguenti ingredienti: The inventors of the present invention have surprisingly found that the following ingredients:
estratto di foglie di sequoia (SEQUOIADENDRON GIGANTEUM) in olio di semi di zucca (CUCURBITA MAXIMA) microincapsulato, estratto di caffè verde (COFFEA ARABICA) contenente acidi clorogenici, sequoia leaf extract (SEQUOIADENDRON GIGANTEUM) in microencapsulated pumpkin seed oil (CUCURBITA MAXIMA), green coffee extract (COFFEA ARABICA) containing chlorogenic acids,
chitosano, chitosan,
mostrano attività sinergica tra di loro in termini di efficacia per il mantenimento delle funzionalità della prostata con attività antimicrobica, antiinfiammatoria ed antiiperlasia prostatica. they show synergistic activity with each other in terms of efficacy for maintaining the functionality of the prostate with antimicrobial, anti-inflammatory and antihyperlasia of the prostate.
Un oggetto della presente invenzione è quindi una composizione a base di: An object of the present invention is therefore a composition based on:
estratto di foglie di sequoia in olio di semi di zucca microincapsulato, sequoia leaf extract in microencapsulated pumpkin seed oil,
estratto di caffè verde contenente acidi clorogenici, chitosano, green coffee extract containing chlorogenic acids, chitosan,
come delineata nelle annesse rivendicazioni da 1 a 8. as outlined in the attached claims 1 to 8.
Un altro oggetto dell’invenzione è un processo di produzione della composizione, come delineato nell’annessa rivendicazione 9. Another object of the invention is a composition production process, as outlined in the attached claim 9.
Un ulteriore oggetto dell’invenzione sono le composizioni dell’invenzione per l’uso nel mantenimento della funzionalità della prostata, come delineato nell’annessa rivendicazione 10. A further object of the invention are the compositions of the invention for use in maintaining the functionality of the prostate, as outlined in the attached claim 10.
Il testo delle annesse rivendicazioni forma parte integrante della presente descrizione. The text of the attached claims forms an integral part of the present description.
Ulteriori caratteristiche e vantaggi delle composizioni e del processo secondo l’invenzione risulteranno dalla descrizione di seguito riportata di esempi di realizzazione, dati a titolo indicativo e non limitativo. Further characteristics and advantages of the compositions and of the process according to the invention will result from the following description of examples of embodiments, given for information only and not limitative.
DESCRIZIONE DETTAGLIATA DELL’INVENZIONE DETAILED DESCRIPTION OF THE INVENTION
Secondo una prima forma di realizzazione, la presente invenzione riguarda una composizione a base di: According to a first embodiment, the present invention relates to a composition based on:
estratto di foglie di sequoia in olio di semi di zucca microincapsulato, sequoia leaf extract in microencapsulated pumpkin seed oil,
estratto di caffè verde contenente acidi clorogenici, chitosano, green coffee extract containing chlorogenic acids, chitosan,
in cui: in which:
- L’estratto di foglie di sequoia in olio di semi di zucca microincapsulato è un estratto liposolubile di foglie di sequoia, comprese foglie, giovani getti e gemme, in olio di semi di zucca. Tale estratto viene poi microincapsulato per conferirgli una forma solida e poter essere utilizzato anche in forme farmaceutiche quali capsule, compresse e granulati. Tale estratto può essere ottenuto mediante macerazione delle foglie di sequoia in olio di zucca, oppure assemblando un estratto liposolubile di sequoia ottenuto, per esempio, in fluidi supercritici quali CO2 supercritica oppure un olio essenziale di sequoia con l'olio di zucca, e successivamente microincapsulando la miscela. L’estratto di foglie di sequoia in olio di semi di zucca microincapsulato è caratterizzato da un contenuto di acidi grassi totali uguale o superiore al 60%p/p e un contenuto di terpeni totali uguale o superiore a 10 ppm. - The sequoia leaf extract in microencapsulated pumpkin seed oil is a fat-soluble extract of sequoia leaves, including leaves, young shoots and buds, in pumpkin seed oil. This extract is then microencapsulated to give it a solid form and can also be used in pharmaceutical forms such as capsules, tablets and granules. This extract can be obtained by macerating sequoia leaves in pumpkin oil, or by assembling a fat-soluble sequoia extract obtained, for example, in supercritical fluids such as supercritical CO2 or an essential oil of sequoia with pumpkin oil, and subsequently microencapsulating the mixture. The sequoia leaf extract in microencapsulated pumpkin seed oil is characterized by a total fatty acid content equal to or greater than 60% w / w and a total terpene content equal to or greater than 10 ppm.
- L'estratto di caffè verde contenente acidi clorogenici è un estratto di caffè verde caratterizzato da un contenuto di polifenoli totali espressi come acidi clorogenici uguale o superiore al 50%p/p. - Green coffee extract containing chlorogenic acids is a green coffee extract characterized by a content of total polyphenols expressed as chlorogenic acids equal to or greater than 50% w / w.
- Il chitosano (numero CAS 9012-76-4) è un polimero della D-glucosammina, che si può ottenere per deacetilazione alcalina della chitina. Il processo industriale attualmente utilizzato è quello di partire dalla chitina purificata ottenuta da crostacei. Il chitosano si solubilizza facilmente e velocemente in soluzione acida per effetto della salificazione dei gruppi funzionali amminici. - Chitosan (CAS number 9012-76-4) is a polymer of D-glucosamine, which can be obtained by alkaline deacetylation of chitin. The industrial process currently used is that of starting from purified chitin obtained from crustaceans. Chitosan solubilizes easily and quickly in an acid solution due to the salification of the amino functional groups.
Secondo una forma di realizzazione preferita dell’invenzione, la suddetta composizione comprende una quantità di estratto di foglie di sequoia in olio di semi di zucca microincapsulato, estratto di caffè verde contenente acidi clorogenici e chitosano tale da apportare per singola dose di somministrazione un contenuto di: According to a preferred embodiment of the invention, the aforesaid composition comprises an amount of sequoia leaf extract in microencapsulated pumpkin seed oil, green coffee extract containing chlorogenic acids and chitosan such as to provide for a single dose of administration a content of :
- polifenoli totali uguale o superiore a 50 mg, - acidi grassi totali uguale o superiore a 150 mg, - polisaccaridi totali uguale o superiore a 20 mg, - total polyphenols equal to or greater than 50 mg, - total fatty acids equal to or greater than 150 mg, - total polysaccharides equal to or greater than 20 mg,
- terpeni totali uguale o superiore a 10 ppm. - total terpenes equal to or greater than 10 ppm.
Secondo una forma di realizzazione preferita dell’invenzione, la suddetta composizione comprende una quantità di estratto di foglie di sequoia in olio di semi di zucca microincapsulato, estratto di caffè verde contenente acidi clorogenici, estratto di melograno contenente punicalagine e punicaline e chitosano tale da apportare per singola dose di somministrazione un contenuto di: According to a preferred embodiment of the invention, the above composition comprises an amount of sequoia leaf extract in microencapsulated pumpkin seed oil, green coffee extract containing chlorogenic acids, pomegranate extract containing punicalagin and punicalin and chitosan such as to provide per single dose of administration a content of:
- polifenoli totali uguale o superiore a 50 mg, - acidi grassi totali uguale o superiore a 150 mg, - polisaccaridi totali uguale o superiore a 20 mg, - terpeni totali uguale o superiore a 10 ppm, - punicaline e punicalagine totali uguale o superiore a 30 mg. - total polyphenols equal to or greater than 50 mg, - total fatty acids equal to or greater than 150 mg, - total polysaccharides equal to or greater than 20 mg, - total terpenes equal to or greater than 10 ppm, - total punicalins and punicalagins equal to or greater than 30 mg.
Secondo una forma di realizzazione preferita dell’invenzione, la suddetta composizione comprende una quantità di estratto di foglie di sequoia in olio di semi di zucca microincapsulato, estratto di caffè verde contenente acidi clorogenici, polvere di Capsicum e chitosano tale da apportare per singola dose di somministrazione un contenuto di: According to a preferred embodiment of the invention, the aforesaid composition comprises a quantity of sequoia leaf extract in microencapsulated pumpkin seed oil, green coffee extract containing chlorogenic acids, Capsicum powder and chitosan such as to provide for a single dose of administration a content of:
- polifenoli totali uguale o superiore a 50 mg, - acidi grassi totali uguale o superiore a 150 mg, - polisaccaridi totali uguale o superiore a 20 mg, - terpeni totali uguale o superiore a 10 ppm, - total polyphenols equal to or greater than 50 mg, - total fatty acids equal to or greater than 150 mg, - total polysaccharides equal to or greater than 20 mg, - total terpenes equal to or greater than 10 ppm,
- capsaicina uguale o superiore a 1 ppm. - capsaicin equal to or greater than 1 ppm.
Secondo una forma di realizzazione preferita dell’invenzione, la suddetta composizione comprende una quantità di estratto di foglie di sequoia in olio di semi di zucca microincapsulato, estratto di caffè verde contenente acidi clorogenici, estratto di tè verde contenente epigallocatechina gallato e chitosano tale da apportare per singola dose di somministrazione un contenuto di: According to a preferred embodiment of the invention, the above composition comprises an amount of sequoia leaf extract in microencapsulated pumpkin seed oil, green coffee extract containing chlorogenic acids, green tea extract containing epigallocatechin gallate and chitosan such as to provide per single dose of administration a content of:
- polifenoli totali uguale o superiore a 100 mg, - acidi grassi totali uguale o superiore a 150 mg, - polisaccaridi totali uguale o superiore a 20 mg, - terpeni totali uguale o superiore a 10 ppm. - total polyphenols equal to or greater than 100 mg, - total fatty acids equal to or greater than 150 mg, - total polysaccharides equal to or greater than 20 mg, - total terpenes equal to or greater than 10 ppm.
Secondo una forma di realizzazione preferita dell’invenzione, la suddetta composizione comprende una quantità di estratto di foglie di sequoia in olio di semi di zucca microincapsulato, estratto di caffè verde contenente acidi clorogenici, polvere di Capsicum e chitosano tale da apportare per singola dose di somministrazione un contenuto di: According to a preferred embodiment of the invention, the aforesaid composition comprises a quantity of sequoia leaf extract in microencapsulated pumpkin seed oil, green coffee extract containing chlorogenic acids, Capsicum powder and chitosan such as to provide for a single dose of administration a content of:
- polifenoli totali uguale o superiore a 120 mg, - acidi grassi totali uguale o superiore a 150 mg, - polisaccaridi totali uguale o superiore a 20 mg, - terpeni totali uguale o superiore a 10 ppm, - capsaicina uguale o superiore a 1 ppm. - total polyphenols equal to or greater than 120 mg, - total fatty acids equal to or greater than 150 mg, - total polysaccharides equal to or greater than 20 mg, - total terpenes equal to or greater than 10 ppm, - capsaicin equal to or greater than 1 ppm.
Il termine “polifenoli totali”, come utilizzato qui, indica la quantità totale di composti a struttura polifenolica, espressi come equivalenti di acido caffeico e determinati analiticamente mediante il metodo di Folin-Ciocalteu [Ainsworth EA e Gillespie KM. Estimation of total phenolic content and other oxidation substrates in plant tissues using Folin-Ciocalteu reagent. Nature Protocols 2007;2:875-875]. The term "total polyphenols", as used herein, indicates the total amount of compounds with a polyphenolic structure, expressed as caffeic acid equivalents and determined analytically by the Folin-Ciocalteu method [Ainsworth EA and Gillespie KM. Estimation of total phenolic content and other oxidation substrates in plant tissues using Folin-Ciocalteu reagent. Nature Protocols 2007; 2: 875-875].
Il termine “acidi grassi totali”, come utilizzato qui, indica la quantità totale di acidi grassi liberi e provenienti dall'idrolisi di loro esteri quali trigliceridi, digliceridi, ecc.. Hanno una struttura di acido monocarbossilico alifatico, prevalentemente, ma non esclusivamente, a lunga catena, con un numero pari di atomi di carbonio, senza ramificazioni e aciclici; possono essere saturi o insaturi. Vengono determinati analiticamente mediante cromatografia gas-liquida [Horning EC, Arrens EH, Lipsky SR, Mattson FH, Mead JF, Turner DA, Goldwater WH. Quantitative Analysis of Fatty Acids by Gas-Liquid Chromatography. J. LipidRes., 1964;5:20-27]. Sono esempi di acidi grassi gli acidi miristico, palmitico, palmitoleico, stearico, oleico, linoleico, alfa-linolenico, arachidonico, eicosenoico, behenico, erucico e simili. The term "total fatty acids", as used here, indicates the total quantity of free fatty acids coming from the hydrolysis of their esters such as triglycerides, diglycerides, etc. They have a structure of aliphatic monocarboxylic acid, mainly, but not exclusively, long chain, with an even number of carbon atoms, without branching and acyclic; they can be saturated or unsaturated. They are determined analytically by gas-liquid chromatography [Horning EC, Arrens EH, Lipsky SR, Mattson FH, Mead JF, Turner DA, Goldwater WH. Quantitative Analysis of Fatty Acids by Gas-Liquid Chromatography. J. LipidRes., 1964; 5: 20-27]. Examples of fatty acids are myristic, palmitic, palmitoleic, stearic, oleic, linoleic, alpha-linolenic, arachidonic, eicosenoic, behenic, erucic acids and the like.
Il termine “polisaccaridi totali”, come utilizzato qui, indica la quantità totale di vari polisaccaridi. I polisaccaridi sono composti chimici organici che appartengono alla classe dei glucidi (carboidrati). Sono caratterizzati da un numero elevato (superiore a 20) di unità ripetitive (monosaccaridi), legate insieme per formare molecole grandi e complesse. I polisaccaridi possono essere lineari o ramificati. Vengono determinati analiticamente mediante metodi spettrofotometrici o HPLC [Food Analysis, a cura di S. Nielsen, 2010; Pomeranz Y, Meloan CE. Food Analysis - Theory and Practice, 2000]. In natura, i polisaccaridi si trovano comunemente nelle piante, dove costituiscono dal 50% al 90%del loro peso secco. The term "total polysaccharides", as used herein, means the total amount of various polysaccharides. Polysaccharides are organic chemical compounds that belong to the class of carbohydrates (carbohydrates). They are characterized by a large number (greater than 20) of repeating units (monosaccharides), bound together to form large and complex molecules. Polysaccharides can be linear or branched. They are determined analytically by spectrophotometric methods or HPLC [Food Analysis, edited by S. Nielsen, 2010; Pomeranz Y, Meloan CE. Food Analysis - Theory and Practice, 2000]. In nature, polysaccharides are commonly found in plants, where they make up 50% to 90% of their dry weight.
Il termine “terpeni totali”, come utilizzato qui, indica la quantità totale di vari composti terpenici e terpenoidi. I terpeni sono molecole costituite da multipli dell'unità isoprenica, che ha la seguente struttura: The term "total terpenes", as used herein, means the total amount of various terpene and terpenoid compounds. Terpenes are molecules made up of multiples of the isoprene unit, which has the following structure:
I terpeni possono avere struttura lineare, ciclica o mista. Vengono prodotti da molte piante, soprattutto conifere, e sono i componenti principali delle resine e degli oli essenziali. Vengono determinati analiticamente mediante analisi gascromatografiche [Zubyk WJ, Conner AZ. Analysis of terpene hydrocarbons andrelated compounds by gas chromatography. Analytical Chemistry, 1960]. Terpenes can have a linear, cyclic or mixed structure. They are produced by many plants, especially conifers, and are the main components of resins and essential oils. They are determined analytically by gas chromatographic analyzes [Zubyk WJ, Conner AZ. Analysis of terpene hydrocarbons and related compounds by gas chromatography. Analytical Chemistry, 1960].
I termini "punicalagine" e "punicaline" indicano sostanze ad attività antiossidante presenti nel frutto del melograno (Punica granatum) e vengono determinate analiticamente mediante analisi cromatografiche (HPLC). The terms "punicalagine" and "punicalin" indicate substances with antioxidant activity present in the fruit of the pomegranate (Punica granatum) and are analytically determined by chromatographic analysis (HPLC).
Il termine "microincapsulazione", come utilizzato qui, indica un processo che consiste nel rivestire minute goccioline di liquido con una sottile pellicola, di solito costituita da polimeri naturali o sintetici, in modo da formare microcapsule. Questa tecnica permette di migliorare o modificare varie caratteristiche e proprietà del materiale microincapsulato, oltre a conferire protezione, stabilizzazione e ad ottimizzarne il rilascio e la biodisponibilità. Il termine “microincapsulato”, come utilizzato qui, indica un estratto vegetale o un olio essenziale sottoposto al processo di microincapsulazione. The term "microencapsulation", as used herein, refers to a process which consists of coating minute droplets of liquid with a thin film, usually made of natural or synthetic polymers, to form microcapsules. This technique allows to improve or modify various characteristics and properties of the microencapsulated material, as well as providing protection, stabilization and optimizing its release and bioavailability. The term "microencapsulated", as used herein, refers to a plant extract or essential oil that has undergone the microencapsulation process.
Il termine “singola dose di somministrazione”, come utilizzato qui, indica la dose di composizione in forma di capsula, compressa, granulato assunta con un'unica somministrazione orale. The term "single dose administration", as used herein, means the dose of composition in capsule, tablet, granulate form taken with a single oral administration.
La composizione dell’invenzione può comprendere anche ulteriori ingredienti ed eccipienti quali, ma senza limitazione, vitamine, minerali, altri estratti vegetali, eccipienti per la microincapsulazione, eccipienti di compressione, emollienti, umettanti, leganti, modificatori della reologia, regolatori di pH, acqua e simili. Per esempio, la composizione dell’invenzione può comprendere maltodestrine, cellulosa microcristallina, gomma arabica, magnesio stearato, silice e simili. The composition of the invention may also comprise further ingredients and excipients such as, but not limited to, vitamins, minerals, other plant extracts, excipients for microencapsulation, compression excipients, emollients, humectants, binders, rheology modifiers, pH regulators, water and similar. For example, the composition of the invention may include maltodextrin, microcrystalline cellulose, gum arabic, magnesium stearate, silica and the like.
Esempi non limitanti di vitamine che possono essere utilizzate nella composizione della presente invenzione sono la vitamina D3 (colecalciferolo) e la vitamina E (tocoferolo) e suoi derivati quali la vitamina E acetato. Non-limiting examples of vitamins that can be used in the composition of the present invention are vitamin D3 (cholecalciferol) and vitamin E (tocopherol) and its derivatives such as vitamin E acetate.
Esempi non limitanti di minerali che possono essere utilizzati nella composizione della presente invenzione sono magnesio, sotto forma, per esempio ma senza limitazione, di magnesio ossido, sodio, sotto forma, per esempio ma senza limitazione, di sodio selenito, e simili. Non-limiting examples of minerals which can be used in the composition of the present invention are magnesium, in the form, for example but without limitation, of magnesium oxide, sodium, in the form, for example but without limitation, of sodium selenite, and the like.
Esempi non limitanti di altri estratti vegetali che possono essere utilizzati nella composizione della presente invenzione sono: un estratto di tè verde (Camellia sinensis), un estratto di Boswellia serrata, un estratto di aglio (Allium sativum), un estratto di Serenoa repens, un estratto di mirtillo (Vaccinium myrtillus), un estratto di Capsicum sp. (per esempio Capsicum annuum), un olio essenziale di menta, un estratto di Pygeum africanume simili. Non-limiting examples of other plant extracts that can be used in the composition of the present invention are: a green tea extract (Camellia sinensis), a Boswellia serrata extract, a garlic extract (Allium sativum), a Serenoa repens extract, a blueberry extract (Vaccinium myrtillus), an extract of Capsicum sp. (for example Capsicum annuum), an essential oil of mint, an extract of Pygeum africanume similar.
Un esempio non limitante di eccipiente per la microincapsulazione che può essere utilizzato nella composizione della presente invenzione è gelatina. A non-limiting example of an excipient for microencapsulation that can be used in the composition of the present invention is gelatin.
La composizione può inoltre contenere ulteriori eccipienti o altri principi attivi a seconda della tipologia di formulazione che si desidera preparare. The composition may also contain further excipients or other active ingredients according to the type of formulation to be prepared.
In certe forme di realizzazione, la composizione è una capsula. In certain embodiments, the composition is a capsule.
In certe forme di realizzazione, la composizione è una compressa. In certain embodiments, the composition is a tablet.
In certe forme di realizzazione, la composizione è un granulato. In certain embodiments, the composition is a granulate.
Un altro oggetto dell’invenzione è un processo di produzione della composizione della presente invenzione. Il processo di produzione comprende le seguenti fasi (Schema 1): Another object of the invention is a production process of the composition of the present invention. The manufacturing process includes the following steps (Scheme 1):
Schema 1: Scheme 1:
cernita delle materie prime sorting of raw materials
miscelazione dei principi attivi contenenti polifenoli con chitosano mixing of the active ingredients containing polyphenols with chitosan
aggiunta degli altri principi attivi e miscelazione addition of the other active ingredients and mixing
aggiunta degli eccipienti e dei veicolati accettabili e addition of excipients and acceptable carriers e
miscelazione mixing
scarico e trasferimento in bulk bulk unloading and transfer
ripartizione e confezionamento distribution and packaging
ESEMPI EXAMPLES
Esempio 1 - composizione in capsule Example 1 - composition in capsules
Mediante il processo illustrato nello Schema 1, una composizione è stata preparata utilizzando i seguenti ingredienti (Tabella 1): By the process illustrated in Scheme 1, a composition was prepared using the following ingredients (Table 1):
Tabella 1. Table 1.
MATERIA PRIMA Quantità Vitamina D3 - colecalciferolo 0,05 mg Capsicumin polvere 5 mg Estratto di foglie di sequoia in olio di semi di 150 mg zucca microincapsulato RAW MATERIAL Quantity Vitamin D3 - cholecalciferol 0.05 mg Capsicumin powder 5 mg Seed oil extract of sequoia 150 mg microencapsulated pumpkin
Sodio selenito 0,1 mg Estratto secco di caffè verde titolato in acidi 240 mg clorogenici al 50% Sodium selenite 0.1 mg Dry extract of green coffee titrated in 240 mg chlorogenic acids at 50%
Chitosano 30 mg Eccipienti q.b. a 500 mg Totale 500 mg Chitosan 30 mg Excipients q.s. to 500 mg Total 500 mg
Esempio 2 - composizione in compresse Example 2 - tablet composition
Mediante il processo illustrato nello Schema 1, una composizione è stata preparata utilizzando i seguenti ingredienti (Tabella 2): By the process illustrated in Scheme 1, a composition was prepared using the following ingredients (Table 2):
Tabella 2. Table 2.
MATERIA PRIMA Quantità Vitamina D3 0,025 mg Licopene 20 mg Estratto di foglie di sequoia in olio di semi di 300 mg zucca microincapsulato RAW MATERIAL Quantity Vitamin D3 0.025 mg Lycopene 20 mg Redwood leaf extract in seed oil 300 mg microencapsulated pumpkin
Zinco ossido 15 mg Olio essenziale di menta microincapsulato 7 mg Estratto di melograno 100 mg Sodio selenito 0,05 mg Vitamina E acetato 12 mg Estratto secco di caffè verde titolato in acidi 100 mg clorogenici al 50% Zinc oxide 15 mg Microencapsulated mint essential oil 7 mg Pomegranate extract 100 mg Sodium selenite 0.05 mg Vitamin E acetate 12 mg Dry extract of green coffee titrated in 100 mg chlorogenic acids at 50%
Chitosano 50 mg Eccipienti q.b. a 800 mg Totale 800 mg Chitosan 50 mg Excipients q.s. at 800 mg Total 800 mg
Esempio 3 - composizione in compresse Example 3 - tablet composition
Mediante il processo illustrato nello Schema 1, una composizione è stata preparata utilizzando i seguenti ingredienti (Tabella 3): By the process illustrated in Scheme 1, a composition was prepared using the following ingredients (Table 3):
Tabella 3. Table 3.
MATERIA PRIMA Quantità Estratto secco di Boswellia serrata titolato in 100 mg acidi boswellici al 65% RAW MATERIAL Quantity Boswellia serrata dry extract titrated in 100 mg 65% boswellic acids
Vitamina D3 0,125 mg Licopene 10 mg Vitamin D3 0.125 mg Lycopene 10 mg
Estratto di foglie di sequoia in olio di semi di 150 mg zucca microincapsulato Redwood Leaf Extract in Microencapsulated Pumpkin 150mg Seed Oil
Estratto di Serenoa repens microincapsulato 80 mg Microencapsulated Serenoa repens extract 80 mg
titolato in acidi grassi all'85% titrated in fatty acids at 85%
Estratto secco di ortica (Urtica dioica) 75 mg Dry extract of nettle (Urtica dioica) 75 mg
Capsicumpolvere 4 mg Capsicum powder 4 mg
Estratto secco di bilberry (Vacciniummyrtillus) 10 mg Estratto secco di zenzero (Zingiber officinale) 5 mg Dry extract of bilberry (Vacciniummyrtillus) 10 mg Dry extract of ginger (Zingiber officinale) 5 mg
titolato in gingeroli al 20% titrated in gingerols at 20%
Estratto secco di tè verde (Camellia sinensis) 50 mg Dry extract of green tea (Camellia sinensis) 50 mg
titolato in epigallocatechina gallato (EGCG) al titrated in epigallocatechin gallate (EGCG) al
95% 95%
Sodio selenito 0,014 mg Zinco ossido 3,5 mg Sodium selenite 0.014 mg Zinc oxide 3.5 mg
Vitamina E acetato 3 mg Vitamin E acetate 3 mg
Estratto secco di caffè verde titolato in acidi 100 mg clorogenici al 50% Dry extract of green coffee titrated in 100 mg chlorogenic acids at 50%
Chitosano 22,5 mg Chitosan 22.5 mg
Eccipienti q.b. a 800 mg Totale 800 Excipients q.s. at 800 mg Total 800
È evidente che sono state descritte solo alcune forme particolari di realizzazione della presente invenzione, cui l’esperto dell’arte sarà in grado di apportare tutte quelle modifiche necessarie per il suo adattamento a particolari applicazioni, senza peraltro discostarsi dall’ambito di protezione della presente invenzione. It is evident that only some particular embodiments of the present invention have been described, to which the skilled in the art will be able to make all those modifications necessary for its adaptation to particular applications, without however departing from the scope of protection of the present invention. invention.
Claims (10)
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