ITUB20153396A1 - Antioxidant association and compositions containing it. - Google Patents
Antioxidant association and compositions containing it. Download PDFInfo
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- ITUB20153396A1 ITUB20153396A1 ITUB2015A003396A ITUB20153396A ITUB20153396A1 IT UB20153396 A1 ITUB20153396 A1 IT UB20153396A1 IT UB2015A003396 A ITUB2015A003396 A IT UB2015A003396A IT UB20153396 A ITUB20153396 A IT UB20153396A IT UB20153396 A1 ITUB20153396 A1 IT UB20153396A1
- Authority
- IT
- Italy
- Prior art keywords
- association
- ketoglutarate
- vitamin
- glutamine
- arginine
- Prior art date
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Classifications
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/44—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
Description
“Associazione antiossidante e composizioni che la contengono” "Antioxidant association and compositions containing it"
Riassunto dell’invenzione Summary of the invention
L’invenzione ha per oggetto una nuova associazione di principi attivi utile per il trattamento dello stress ossidativo ed in particolare per la cura dei capelli e della pelle, e delle composizioni adatte alla sua somministrazione. The invention relates to a new association of active ingredients useful for the treatment of oxidative stress and in particular for hair and skin care, and compositions suitable for its administration.
Contesto tecnico Technical context
Le specie reattive dell’ossigeno sono generate da una moltitudine di cause endogene ed ambientali. Tali specie reattive dell’ossigeno insieme ai radicali liberi sono molecole altamente reattive che possono danneggiare direttamente le membrane cellulari strutturali, lipidi, proteine e il DNA. Il nostro organismo possiede meccanismi di difesa endogeni, come gli enzimi antiossidanti e molecole antiossidanti non enzimatiche, che proteggono dai radicali liberi, riducendoli e neutralizzandoli. Quando questi meccanismi si alterano, si genera uno squilibrio tra radicali liberi e antiossidanti naturali presenti in ogni cellula che determina una situazione di “stress ossidativo”. L’espressione “stress ossidativo” è ben nota e indica una condizione patologica causata dalla rottura deH'equilibrio fisiologico ria la produzione e l'eliminazione, da parte dei sistemi di difesa antiossidanti, di specie chimiche ossidanti in un organismo. Reactive oxygen species are generated by a multitude of endogenous and environmental causes. These reactive oxygen species together with free radicals are highly reactive molecules that can directly damage structural cell membranes, lipids, proteins and DNA. Our body has endogenous defense mechanisms, such as antioxidant enzymes and non-enzymatic antioxidant molecules, which protect against free radicals, reducing and neutralizing them. When these mechanisms are altered, an imbalance is generated between free radicals and natural antioxidants present in each cell which determines a situation of "oxidative stress". The expression "oxidative stress" is well known and indicates a pathological condition caused by the disruption of the physiological balance and the production and elimination, by the antioxidant defense systems, of oxidizing chemical species in an organism.
Quando è presente uno stress ossidativo la cellula, attaccata dai radicali liberi, perde le sue caratteristiche morfologiche e funzionali e non è più in grado di svolgere le funzioni per cui è preposta. When oxidative stress is present, the cell, attacked by free radicals, loses its morphological and functional characteristics and is no longer able to perform the functions for which it is designed.
Lo stress ossidativo svolge un molo importante nel processo di invecchiamento cellulare ed interessa anche il bulbo del follicolo pilifero; gli effetti che genera sono da un lato una diminuzione della funzione dei melanociti (ingrigimento) e dall’altro un progressivo indebolimento dei capelli. Uno stress che si protrae nel tempo può danneggiare le cellule del bulbo pilifero dando luogo ad un capello debole, fragile e tendente alla caduta. Il glutatione (GSH) è il principale antiossidante intracellulare. Gli eritrociti umani (RBC) richiedono un apporto continuo di glutammato per prevenire la limitazione di sintesi di GSH, anche se in presenza di livelli sufficienti di cisteina, ma la membrana RBC è quasi impermeabile al glutammato, come del resto al GSH esogeno. Oxidative stress plays an important role in the cellular aging process and also affects the bulb of the hair follicle; the effects it generates are on the one hand a decrease in the function of melanocytes (graying) and on the other a progressive weakening of the hair. A stress that lasts over time can damage the cells of the hair bulb giving rise to a weak, fragile and prone to falling out hair. Glutathione (GSH) is the main intracellular antioxidant. Human erythrocytes (RBCs) require a continuous supply of glutamate to prevent the limitation of GSH synthesis, even if in the presence of sufficient levels of cysteine, but the RBC membrane is almost impermeable to glutamate, as indeed to exogenous GSH.
Per questo motivo, gli integratori alimentali comprendenti GSH non riescono ad essere efficaci nel contrastare lo stress ossi dativo e ad arginare i danni da esso prodotti. For this reason, dietary supplements including GSH fail to be effective in counteracting oxidative stress and stemming the damage it produces.
Esistono in commercio integratori alimentari comprendenti vitamine e amminoacidi ma spesso si tratta di miscele non bilanciate che non forniscono un reale apporto di nutrienti mirato ad ottenere uno specifico effetto nell’ organismo. There are food supplements on the market including vitamins and amino acids but often these are unbalanced mixtures that do not provide a real supply of nutrients aimed at obtaining a specific effect in the body.
Esiste pertanto la necessità di disporre di integratori alimentari e composizioni nutraceutiche dosati in modo opportuno, che siano realmente efficaci nel trattamento dello stress ossidativo e dei disturbi ad esso connessi. Therefore, there is a need to have food supplements and nutraceutical compositions dosed in an appropriate way, which are really effective in the treatment of oxidative stress and related disorders.
Scopi dell’ invenzione Aims of the invention
E uno scopo dell’invenzione fornire una specifica associazione di sostanze che forniscano all’organismo un corretto e bilanciato apporto di nutrienti per contrastare lo stress ossi dativo. It is an aim of the invention to provide a specific association of substances that provide the body with a correct and balanced supply of nutrients to counteract oxidative stress.
E un ulteriore scopo dell’invenzione fornire delle composizioni nutraceutiche che comprendono detta associazione, eventualmente insieme ad altri componenti benefici per l’organismo. It is a further purpose of the invention to provide nutraceutical compositions that include said association, possibly together with other beneficial components for the body.
Descrizione dell’invenzione Description of the invention
Secondo uno dei suoi aspetti l’invenzione ha per oggetto un’associazione composta da un precursore della cisteina, glieina, glutammina e arginina-chetoglutarato, detta associazione essendo utile nel trattamento e nella prevenzione dello stress ossidativo. Per “precursore della cisteina” si intende qui indicare un “pro-drug” della cisteina, cioè un composto in grado di rilasciare cisteina dopo la sua somministrazione. A titolo di esempio, l’espressione include N-acetil cisteina, l’OTC (acido L-2-oxo-tiazolidina-4-carbossilico e i suoi sali) e l’oxiprolina, la N-acetilcisteina essendo preferita. According to one of its aspects, the invention relates to an association consisting of a cysteine precursor, glieine, glutamine and arginine-ketoglutarate, said association being useful in the treatment and prevention of oxidative stress. By "cysteine precursor" we mean here a "pro-drug" of cysteine, ie a compound capable of releasing cysteine after its administration. By way of example, the expression includes N-acetyl cysteine, OTC (L-2-oxo-thiazolidine-4-carboxylic acid and its salts) and oxyproline, N-acetylcysteine being preferred.
In alternativa alla arginina-chetoglutarato è possibile utilizzare l’omitina-chetoglutarato. Secondo una forma di realizzazione preferita, l’invenzione ha per oggetto un’associazione composta da N-acetilcisteina, glieina, glutammina e argininachetoglutarato. As an alternative to arginine-ketoglutarate, it is possible to use omithin-ketoglutarate. According to a preferred embodiment, the invention relates to an association composed of N-acetylcysteine, gliein, glutamine and arginine ketoglutarate.
Secondo una fonna di realizzazione preferita, l’associazione è un’associazione fissa, in cui i componenti N-acetilcisteina/glicina/glutammina/arginina-chetoglutarato sono in un rapporto in peso di 1/1-2/1 -2/1 -2, vale a dire che per una parte in peso di N-acetilcisteina, possono essere presenti da 1 a 2 parti in peso degli albi componenti. According to a preferred embodiment, the association is a fixed association, in which the N-acetylcysteine / glycine / glutamine / arginine-ketoglutarate components are in a weight ratio of 1 / 1-2 / 1 -2/1 - 2, that is to say that for one part by weight of N-acetylcysteine, from 1 to 2 parts by weight of the component parts can be present.
Un’associazione particolarmente preferita secondo l’invenzione è costituita da N-acetilcisteina/glicina/glutammina/arginina-chetoglutarato in un rapporto in peso di circa 1/1, 6-1, 7/1, 6-1, 7/1, 6-1, 7. A particularly preferred combination according to the invention is constituted by N-acetylcysteine / glycine / glutamine / arginine-ketoglutarate in a weight ratio of about 1/1, 6-1, 7/1, 6-1, 7/1, 6-1, 7.
I componenti dell’associazione sono composti noti alla tecnica e disponibili sul mercato. Pur senza voler essere legati ad alcuna particolare teoria, si è osservato che l’associazione dell’invenzione, ed in particolare le associazioni preferite, sono in grado di aumentare in modo ottimale la sintesi intracellulare di glutatione (GSH). The components of the association are compounds known to the art and available on the market. Without wishing to be tied to any particular theory, it was observed that the association of the invention, and in particular the preferred associations, are able to optimally increase the intracellular synthesis of glutathione (GSH).
Cosi, grazie all’ invenzione, è possibile somministrare il giusto apporto di componenti per al fine di fornire alle cellule dell’ organismo gli elementi indispensabili per sintetizzare GSH sfintt andò vie metaboliche fisiologiche, quindi ogni qual volta condizioni contingenti di carenza ne richiedano la disponibilità. Questo approccio pennette di evitare rischio di sovra- e/o sotto-dosaggi, in quanto la biosintesi viene autoregolata a seconda delle necessità del soggetto. Come detto inoltre, nel caso in questione, il GSH assunto per via orale, risulta scarsamente biodisponibile dal momento che non è in grado di attraversare la membrana cellulare con il rischio che, rimanendo inutilizzato in circolo, porti a fenomeni di auto-ossidazione e di formazione di pericolosi tiil-radicali (RS ). L’associazione dell’invenzione può essere somministrata per via sistemica, vantaggiosamente per via orale. Thus, thanks to the invention, it is possible to administer the right amount of components in order to provide the cells of the organism with the essential elements to synthesize GSH sfintt va physiological metabolic pathways, therefore whenever contingent conditions of deficiency require their availability. This approach makes it possible to avoid the risk of over- and / or under-dosages, as the biosynthesis is self-regulated according to the needs of the subject. As mentioned furthermore, in the case in question, the GSH taken orally, is poorly bioavailable since it is not able to cross the cell membrane with the risk that, remaining unused in the circulation, it leads to phenomena of self-oxidation and formation of dangerous thiyl radicals (RS). The association of the invention can be administered systemically, advantageously orally.
Per la sua somministrazione nell’uomo o più in generale nel mammifero, l’associazione è preferibilmente somministrata in forma di composizioni, farmaceutiche o nutraceutiche, insieme ai veicoli e agli eccipienti comunemente utilizzati e bennoto all’esperto del ramo. La composizione può essere in forma di unità di dosaggio o multidose, la fonna di unità di dosaggio essendo preferita. For its administration in humans or more generally in mammals, the combination is preferably administered in the form of compositions, pharmaceutical or nutraceutical, together with the commonly used vehicles and excipients and for the benefit of the skilled in the art. The composition can be in the form of dosage units or multidose, the dosage unit form being preferred.
Per le composizioni orali, possono ad esempio essere preparate fonne solide quali capsule, compresse, granulati, polveri o fonne liquide come sospensioni o soluzioni. Preferibilmente, le composizioni dell’invenzione sono in fonna solida, vantaggiosamente in forma di compresse, ad esempio di compresse rivestite. For oral compositions, solid forms such as capsules, tablets, granulates, powders or liquid forms such as suspensions or solutions can for example be prepared. Preferably, the compositions of the invention are in solid form, advantageously in the form of tablets, for example of coated tablets.
L’associazione e le composizioni dell’ invenzione sono particolarmente utili nel trattamento e nella prevenzione dello stress ossidativo ed in particolare nella protezione dei capelli e della pelle. The combination and compositions of the invention are particularly useful in the treatment and prevention of oxidative stress and in particular in the protection of hair and skin.
La composizione orale può inoltre comprendere altre sostanze attive nella protezione dallo stress ossidativo. The oral composition may further comprise other active substances in the protection from oxidative stress.
Secondo una fonna di realizzazione preferita, la composizione comprendente l’associazione oggetto del presente brevetto, può comprendere anche ingredienti attivi e/o nutrienti specifici per la cura della pelle e/o dei capelli. According to a preferred embodiment, the composition comprising the association object of this patent, may also include specific active ingredients and / or nutrients for skin and / or hair care.
A titolo di esempio, una composizione da utilizzare per la cura dei capelli può comprendere, oltre all’ associazione dell’invenzione anche una o più sostanze scelte tra selenio, rame e zinco, vitamina PP, vitamina H vitamine del gruppo B quali la vitamina B6 e la vitamina B2. By way of example, a composition to be used for hair care may include, in addition to the association of the invention, also one or more substances selected from selenium, copper and zinc, vitamin PP, vitamin H, vitamins of group B such as vitamin B6 and vitamin B2.
Inoltre, un’ulteriore causa della fragilità e successiva caduta dei capelli è nota essere l’attività della 5-alfa-riduttasi, un enzima che agisce sul testosterone riducendolo a diidrotestosterone, il cui eccesso causa seborrea e calvizie androgenica. Degli estratti adatti a tale scopo sono l’estratto di riso nero e l’estratto di fico d’india. In addition, a further cause of fragility and subsequent hair loss is known to be the activity of 5-alpha-reductase, an enzyme that acts on testosterone reducing it to dihydrotestosterone, the excess of which causes seborrhea and androgenic baldness. Suitable extracts for this purpose are black rice extract and prickly pear extract.
Pertanto, le composizioni comprendenti l’associazione possono contenere anche altri inibitori deH’attività enzimatica della 5-alfa-riduttasi, di natura sintetica o naturale, quali per esempio serenoa repens, catechine (es. da thè verde), fitosteroli (es. da cucurbitacee), isoflavoni (es. da soia), omega 3 . Therefore, the compositions comprising the association can also contain other inhibitors of the enzymatic activity of 5-alpha-reductase, of a synthetic or natural nature, such as for example serenoa repens, catechins (e.g. from green tea), phytosterols (e.g. from cucurbits), isoflavones (e.g. from soy), omega 3.
Allo stesso modo, una composizione da utilizzare per la cura della pelle comprenderebbe, oltre all’ associazione dell’invenzione anche una o più sostanze scelte tra acido lipoico; carnosina; amminoacidi ramificati quali valina, leucina e isoleucina; serina e acido folico e estratti di piante benefici per questa applicazione. Similarly, a composition to be used for skin care would include, in addition to the association of the invention, also one or more substances selected from lipoic acid; carnosine; branched chain amino acids such as valine, leucine and isoleucine; serine and folic acid and beneficial plant extracts for this application.
Degli esempi rappresentativi di tali composizioni sono riportati, a titolo esemplificativo e non limitativo, nella sezione sperimentale della presente descrizione. Representative examples of such compositions are reported, by way of non-limiting example, in the experimental section of the present description.
Le quantità di associazione da somministrare possono variare in funzione del grado di stress ossidativo, come pure della specifica patologia da riattare, del peso e delle condizioni generali del soggeto da tratare. The quantities of association to be administered may vary according to the degree of oxidative stress, as well as the specific pathology to be restored, the weight and general conditions of the subject to be treated.
In linea generale, si potrebbero somministrare quotidianamente da 30 a 600 mg di N-acetilcisteina, da 50 a 1000 mg di glieina, da 50 a 1000 mg di glutammina e da 50 a 1000 mg di arginina-chetoglutarato. In general, 30 to 600 mg of N-acetylcysteine, 50 to 1000 mg of gliein, 50 to 1000 mg of glutamine and 50 to 1000 mg of arginine-ketoglutarate could be administered daily.
Vantaggiosamente, si somministreranno quotidianamente da 30 a 60 mg, preferibilmente da 40 a 50 mg di N-acetil cisteina, da 50 a 100 mg, preferibilmente da 70 a 80 mg di glieina, da 50 a 100 mg, preferibilmente da 70 a 80 mg di glutammina e da 50 a 100 mg, preferibilmente da 70 a 80 mg di arginina-chetoglutarato. Advantageously, from 30 to 60 mg, preferably from 40 to 50 mg of N-acetyl cysteine, from 50 to 100 mg, preferably from 70 to 80 mg of glyin, from 50 to 100 mg, preferably from 70 to 80 mg, will be administered daily. of glutamine and from 50 to 100 mg, preferably from 70 to 80 mg of arginine-ketoglutarate.
Dei dosaggi giornalieri preferiti sono approssimativamente 45 mg di N-acetilcisteina, 75 mg di glieina, da 75 mg di glutammina e da 75 mg di arginina-chetoglutarato. Preferred daily dosages are approximately 45 mg of N-acetylcysteine, 75 mg of gliein, 75 mg of glutamine and 75 mg of arginine-ketoglutarate.
Gli altri componenti eventualmente presenti nella composizione, saranno dosati in base alla corrispondente dose giornaliera raccomandata. The other components possibly present in the composition will be dosed on the basis of the corresponding recommended daily dose.
L’uso dell’associazione e delle composizioni dell’invenzione nella prevenzione e nel tratamento dello stress ossidativo e nella cura dei capelli e della pelle rappresenta un ulteriore oggeto dell’invenzione. The use of the combination and compositions of the invention in the prevention and treatment of oxidative stress and in the care of hair and skin represents a further object of the invention.
E un ulteriore oggeto dell’ invenzione un metodo di riatamento che comprende somministrare ad un mammifero che lo necessita, vantaggiosamente a un essere umano, una quantità efficace di un’associazione o di una composizione dell’invenzione. A further object of the invention is a method of reactivation which comprises administering to a mammal that needs it, advantageously to a human being, an effective amount of an association or composition of the invention.
Una composizione rappresentativa dell’invenzione è stata sotoposta a saggi clinici su volontari, detti saggi essendo volti a valutare, prima e dopo la somministrazione dell’associazione, lo stato ossidativo ed infiammatorio. A representative composition of the invention was subjected to clinical tests on volunteers, said tests being aimed at assessing, before and after administration of the association, the oxidative and inflammatory state.
Si è inoltre verificato se la somministrazione avesse creato un ambiente antiossidante ed anti -infiammatorio favorevole all' attivazione della fase di anagen, essendo in grado di aumentarne la durata e, in sinergia con gli inibitori di 5-alfa ridutasi, di combattere dairintemo il problema dei capelli fragili e indeboliti con tendenza alla caduta, spostando la fase di catagen. It was also verified whether the administration had created an antioxidant and anti-inflammatory environment favorable to the activation of the anagen phase, being able to increase its duration and, in synergy with the 5-alpha redutase inhibitors, to fight the problem from within. brittle and weakened hair with a tendency to fall out, shifting the catagen phase.
Si è anche verificato se i quantitativi dei principi attivi dell’ associazione somministrati fossero sufficienti ad ottenere differenze significativamente positive (p<0,05) rispetto ai valori basali. It was also verified whether the quantities of the active ingredients of the association administered were sufficient to obtain significantly positive differences (p <0.05) from baseline values.
Questa sperimentazione ha portato a risultati molto positivi e promettenti. I dettagli dei saggi sono riportati nella sezione sperimentale che segue. This experimentation has led to very positive and promising results. The details of the assays are reported in the experimental section below.
Sezione sperimentale Experimental section
Esempio 1 Example 1
Si preparano delle compresse rivestite ciascuna contenente: Coated tablets are prepared each containing:
Glicina 75,00 mg Glycine 75.00 mg
Glutammina 75,00 mg Glutamine 75.00 mg
Aiginina alfa-chetoglutarato 75,00 mg Aiginine alpha-ketoglutarate 75.00 mg
N-ac etri cisteina 45,00 mg N-ac etri cysteine 45.00 mg
Vitamina PP 16,00 mg Vitamin PP 16.00 mg
Zinco da zinco ossido 10,00 mg Zinc from zinc oxide 10.00 mg
Selenio (lievito) 55,00 microg Selenium (yeast) 55.00 microg
Rame da rame gluconato 1,00 mg Copper from copper gluconate 1.00 mg
Vitamina B6 1 ,40 mg Vitamin B6 1, 40 mg
Vitamina B2 1,40 mg Vitamin B2 1.40 mg
Vitamina H 50,00 microg Vitamin H 50.00 microg
Estratto di riso nero e di fico d’india 100,00 mg Extract of black rice and prickly pear 100.00 mg
con eccipienti convenzionali. with conventional excipients.
Esempio 2 Example 2
Si preparano delle compresse rivestite ciascuna contenente: Coated tablets are prepared each containing:
Glieina 75,00 mg Gliein 75.00 mg
Glutammina 75,00 mg Glutamine 75.00 mg
Arginina alfa-chetoglutarato 75,00 mg Arginine alpha-ketoglutarate 75.00 mg
N-acetil cisteina 45,00 mg N-acetyl cysteine 45.00 mg
Vitamina PP 16,00 mg Vitamin PP 16.00 mg
Zinco da zinco ossido 10,00 mg Zinc from zinc oxide 10.00 mg
Selenio (lievito) 55,00 microg Selenium (yeast) 55.00 microg
Rame da rame gluconato 1,00 mg Copper from copper gluconate 1.00 mg
Vitamina B6 1 ,40 mg - mg 6,00 (300% RDA) Vitamina B2 1 ,40 mg - mg 4,8 (300% RDA) Vitamina H 50,00 microg Vitamin B6 1, 40 mg - 6.00 mg (300% RDA) Vitamin B2 1, 40 mg - 4.8 mg (300% RDA) Vitamin H 50.00 microg
con eccipienti convenzionali. with conventional excipients.
Esempio 3 Example 3
Si preparano delle compresse rivestite ciascuna contenente: Coated tablets are prepared each containing:
Glieina 75,00 mg -1000,00 mg Glutammina 75,00 mg - 1000,00 mg Arginina alfa-chetoglutarato 75,00 mg - 1000,00 mg Gliein 75.00 mg -1000.00 mg Glutamine 75.00 mg - 1000.00 mg Arginine alpha-ketoglutarate 75.00 mg - 1000.00 mg
N-acetilcisteina 45,00 mg - 600,00 mg Acido lipoico 100,00 mg -300,00 mg Camosina 100,00 mg - 500,00 mg Vaiina 75,00 mg - 1000,00 mg Isoleucina 75,00 mg - 1000,00 mg Senna 75,00 mg - 1000,00 mg Leucina 150,00 mg -2000,00 mg Acido folico 400 microg - 15 mg (o 5 mg se sotto fonna di 5 -metri tetraidrofolico) con eccipienti convenzionali. N-acetylcysteine 45.00 mg - 600.00 mg Lipoic acid 100.00 mg -300.00 mg Camosina 100.00 mg - 500.00 mg Vaiina 75.00 mg - 1000.00 mg Isoleucine 75.00 mg - 1000 .00 mg Senna 75.00 mg - 1000.00 mg Leucine 150.00 mg -2000.00 mg Folic acid 400 microg - 15 mg (or 5 mg if in the form of 5-meter tetrahydrofolic) with conventional excipients.
Esempio 4 Example 4
Studio clinico per la valutazione deirefficacia della composizione dell" esempio 1 , Disegno dello studio Clinical study for the evaluation of the efficacy of the composition of Example 1, Study design
Sono stati arruolati 12 volontari sani, asintomatici (6 maschi e 6 femmine), con problemi di perdita anomala dei capelli (telogen effluvium, alopecia, ecc..), suddivisi in tre gruppi secondo fasce d'età comprese tra i 30 ed i 70 armi : A (30 - 40); B (40 - 50); C (50 - 70) Criteri di inclusione 12 healthy, asymptomatic volunteers (6 males and 6 females), with problems of abnormal hair loss (telogen effluvium, alopecia, etc.) were enrolled, divided into three groups according to age groups between 30 and 70. weapons: A (30 - 40); B (40 - 50); C (50 - 70) Inclusion criteria
• volontari di ambo i sessi con età compresa tra i 30 e i 70 anni • volunteers of both sexes aged between 30 and 70 years
• problemi di perdita anomala dei capelli (telogen effluvium, alopecia, ecc..) Criteri di esclusione • problems with abnormal hair loss (telogen effluvium, alopecia, etc ..) Exclusion criteria
• Donne in gravidanza • Pregnant women
• Uso regolare di farmaci inibenti il metabolismo deiromocisteina (metotrexato, antiepilettici, ecc.) • Regular use of drugs that inhibit the metabolism of homocysteine (methotrexate, antiepileptics, etc.)
• Portatori di neoplasie • Carriers of neoplasms
• Terapia con chemioterapici • Chemotherapy therapy
I partecipanti allo studio, dopo aver firmato il consenso infonnato, sono stati divisi in rie gruppi in base all'età (A, B e C). Ogni gruppo è costituito da 4 volontari: 2 maschi e 2 femmine. The study participants, after signing the informed consent, were divided into groups based on age (A, B and C). Each group consists of 4 volunteers: 2 males and 2 females.
Ai volontari arruolati nei gruppi A, B e Cè stata consegnatala composizione dell’ esempio 1, in forma di compresse rivestite, che è stata assunta tutti i giorni per 3 mesi nella posologia di 1 compressa al giorno, da assumere a stomaco pieno (dopo un pasto) ed è stato fatto un prelievo ematico (TO). The volunteers enrolled in groups A, B and C were given the composition of example 1, in the form of coated tablets, which was taken every day for 3 months in the dosage of 1 tablet per day, to be taken on a full stomach (after a meal) and a blood sample (TO) was taken.
RISULTATI e considerazioni dopo 4 settimane di trattamento. RESULTS and considerations after 4 weeks of treatment.
Α1Γ arruolamento, eseguito secondo i criteri di inclusione/esclusione enunciati nel protocollo, sono stati inseriti ulteriori elementi di valutazione, sia biochimici che osservazionali. Oltre ai parametri elencati nel protocollo, sono stati esaminati: le transaminasi ALT e durante la visita medica, oltre ad una intervista sulle abitudini alimentari, è stata introdotta un’analisi obiettiva sullo stato dei capelli di ogni partecipante al protocollo. Α1Γ enrollment, performed according to the inclusion / exclusion criteria set out in the protocol, additional elements of both biochemical and observational evaluation were included. In addition to the parameters listed in the protocol, the following were examined: ALT transaminases and during the medical examination, in addition to an interview on eating habits, an objective analysis was introduced on the state of the hair of each participant in the protocol.
Stato redox dei tioli e GSH Redox state of thiols and GSH
ALT alanina aminotransferasi ALT alanine aminotransferase
Circa il 90% del pool di glutammato intracellulare è attribuibile alTattività della alanina amino transferasi; pertanto in base a ciò, il glutammato prodotto da ALT è principalmente quello usato per la sintesi e l' incorporazione nel GSH. Nello studio ALT (tab.l) diminuisce significativamente (p< 0,01); tale comportamento è presumibilmente dovuto al maggior coinvolgimento di questa transaminasi citosolica e mitocondriale nella sintesi “de novo” del glutammato. La diminuzione delle ALT dimostra Tinstaurarsi di uno stato antiossidante e detossificante, con conseguente miglioramento metabolico generale. Conclusioni About 90% of the intracellular glutamate pool is attributable to the activity of the alanine amino transferase; therefore based on this, the glutamate produced by ALT is mainly that used for synthesis and incorporation into GSH. In the study ALT (table 1) decreased significantly (p <0.01); this behavior is presumably due to the greater involvement of this cytosolic and mitochondrial transaminase in the "de novo" synthesis of glutamate. The decrease in ALT demonstrates the establishment of an antioxidant and detoxifying state, with consequent general metabolic improvement. Conclusions
In questa parte dello studio risulta evidente anche che tutti i partecipanti allo studio mostrano al prelievo basale, valori di GSH ridotto vicini ai limiti minimi di riferimento (Tintervallo di riferimento nella popolazione di controllo è compreso ria 400 mcM e 2600 mcM); 8 partecipanti al protocollo, dopo 4 settimane, aumentando i propri livelli di GSH, sono in grado di contrastare il problema dei capelli fragili e indeboliti con tendenza alla caduta. Pertanto si è dimostrato che il GSH prodotto attraverso l’integrazione sistemica In this part of the study it is also evident that all study participants show at baseline reduced GSH values close to the minimum reference limits (the reference range in the control population is between 400 mcM and 2600 mcM); 8 participants in the protocol, after 4 weeks, by increasing their GSH levels, are able to counteract the problem of brittle and weakened hair with a tendency to fall. Therefore, it has been shown that GSH produced through systemic integration
di opportuni substrati, gioca un ruolo importante nel rallentare la caduta dei capelli e nel of suitable substrates, plays an important role in slowing hair loss and in
contrastare in generale lo stress metabolico. generally counteract metabolic stress.
Abbreviazioni: Abbreviations:
GSH = glutatione; er = eritrociti ridotti; eo = eritrociti ossidati; GSH = glutathione; er = reduced erythrocytes; eo = oxidized erythrocytes;
Tab. 1 Tab. 1
ALT ALT
to tl to tl
media 30-40 anni 14.75 13.50 average 30-40 years 14.75 13.50
media 40-50 anni 17.25 14.25 average 40-50 years 17.25 14.25
media 50-70 anni 16.75 15.50 average 50-70 years 16.75 15.50
media totale 16.25 14.42 total average 16.25 14.42
T-Test p = 0.007557 T-Test p = 0.007557
Tab. 2 Tab. 2
GSH er GSH er
to tl to tl
media 30-40 anni 446.86 585.03 average 30-40 years 446.86 585.03
media 40-50 anni 362.33 493.93 average 40-50 years 362.33 493.93
media 50-70 anni 527.96 590.17 average 50-70 years 527.96 590.17
media totale 445.72 556.38 total average 445.72 556.38
t-test p = 0.000191 t-test p = 0.000191
GSH eo GSH and o
to tl to tl
media 30-40 anni 1338.35 1110.22 average 30-40 years 1338.35 1110.22
media 40-50 anni 1620.60 1311.40 average 40-50 years 1620.60 1311.40
media 50-70 anni 1519.00 1315.56 average 50-70 years 1519.00 1315.56
media totale 1492.65 1245.72 total average 1492.65 1245.72
t-test p = 8.42E-05 t-test p = 8.42E-05
Claims (10)
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| EP2033623A1 (en) * | 2007-09-07 | 2009-03-11 | Cutech S.R.L. | Compositions comprising ornithine ketoglutarate (OKG) |
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