SI25053A - Extract from the wood of trees of the genus fir to prevent, alleviate or treat unwanted skin changes and preparations - Google Patents

Extract from the wood of trees of the genus fir to prevent, alleviate or treat unwanted skin changes and preparations Download PDF

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SI25053A
SI25053A SI201500214A SI201500214A SI25053A SI 25053 A SI25053 A SI 25053A SI 201500214 A SI201500214 A SI 201500214A SI 201500214 A SI201500214 A SI 201500214A SI 25053 A SI25053 A SI 25053A
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extract
skin
polyphenols
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preparations
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Katja Žmitek
Nataša Tavčar
Tina PogaÄŤnik
Petra Keršmanc
Tadej Rejc
Uroš Petric
TRUKELJ Borut Ĺ
Samo Kreft
Janko ŽMITEK
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Abies Labs D.O.O.
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    • 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
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9755—Gymnosperms [Coniferophyta]
    • A61K8/9767—Pinaceae [Pine family], e.g. pine or cedar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

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Abstract

Izum se nanaša na izvleček iz lesa dreves iz rodu jelka (Abies), prednostno lesa bele jelke (Abies alba), zlasti še iz grč, ki vsebuje zmes naravnih polifenolov z zmanjšanim deležem visokomolekularnih polifenolov, in sicer za 15-100 % glede na celotno vsebnost naravnih polifenolov, ter z analogno povečanim deležem nizkomolekularnih polifenolov z molsko maso pod 1000 Da za preprečevanje, zmanjševanje oz. zdravljenje neželenih sprememb kože v kozmetični in dermatološki uporabi, in sicer izvlečka samega ali vobliki formuliranih kozmetičnih in farmacevtskih pripravkov za kozmetično in dermatološko uporabo. Ker je delež visokomolekularnih polifenolov v izvlečku bistveno manjši in delež nizkomolekularnih polifenolov bistveno večji, kot v do sedaj znanih zmeseh oziroma izvlečkih iz iglavcev, je penetracija v kožo bistveno izboljšana. Izvleček uporabimo ali v obliki koncentrata ali trdne suhe zmesi za dermalno uporabo neposredno ali v obliki tekočih, poltrdnih in trdnih pripravkov, kot so dermalne tekočine,vključno s pršili, kapljicami, šamponi in obkladki, dermalni praški (posipala), hidrofilni geli, hidrofilne kreme, hidrofobne kreme, mazila, paste, obliži in drugo.The invention relates to an extract from wood of fir trees (Abies), preferably white fir (Abies alba), especially from a cramp containing a mixture of natural polyphenols with a reduced proportion of high molecular weight polyphenols, by 15-100% relative to the total the content of natural polyphenols and an analogously increased proportion of low molecular weight polyphenols with a molecular weight below 1000 Da for preventing, treatment of unwanted skin changes in cosmetic and dermatological use, namely, the extract itself or the shape of formulated cosmetic and pharmaceutical preparations for cosmetic and dermatological use. Since the proportion of high molecular weight polyphenols in the extract is significantly lower and the proportion of low molecular weight polyphenols is significantly higher than in the so far known mixtures or extracts from conifers, penetration into the skin is significantly improved. The extract is used either in the form of a concentrate or a solid dry mixture for dermal use either directly or in the form of liquid, semi-solid and solid preparations, such as dermal liquids, including sprays, drops, shampoos and compresses, dermal powders (sprays), hydrophilic gels, hydrophilic creams , hydrophobic creams, ointments, pastes, patches and others.

Description

IZVLEČEK IZ LESA DREVES IZ RODU JELKA ZA PREPREČEVANJE, LAJŠANJE IN ZDRAVLJENJE NEŽELENIH SPREMEMB KOŽE TER PRIPRAVKIWOODEN EXTRACT OF TREES OF A TREE FOR PREVENTING, RELIEVING AND TREATING ADVERSE SKINS AND PREPARATIONS

Predmet izuma je uporaba izvlečka iz lesa jelke in pripravkov, ki ta izvleček vsebujejo, za preprečevanje, lajšanje in zdravljenje neželenih sprememb kože, kar omogoča učinkovito uporabo v kozmetične in dermatološke namene.The object of the invention is the use of extracts from fir tree and preparations containing this extract for the prevention, alleviation and treatment of unwanted skin changes, which enables effective use for cosmetic and dermatological purposes.

Izum se nanaša na zvleček iz lesa dreves iz rodu jelka (Abies), prednostno lesa bele jelke (Abies alba), zlasti še iz grč, ki vsebuje zmes naravnih polifenolov z zmanjšanim deležem visokomolekularnih polifenolnih učinkovin, za uporabo za preprečevanje, lajšanje in zdravljenje neželenih sprememb kože, ter na formulirane farmacevtske in kozmetične pripravke, ki vsebujejo predmetni izvleček, prav tako pa tudi na uporabo teh pripravkov za navedene namene.The invention relates to a tree-tree tree of the genus Abies, preferably a white-tree tree (Abies alba), in particular, of hives containing a mixture of natural polyphenols with a reduced content of high molecular weight polyphenolic agents for use in the prevention, alleviation and treatment of unwanted skin changes, as well as formulated pharmaceutical and cosmetic preparations containing the subject extract, as well as the use of these preparations for those purposes.

V nadaljevanju bodo uporabljene naslednje enakopomenke in kratice:The following synonyms and abbreviations will be used below:

- polifenolne spojine: polifenoli ali polifenolne učinkovine- polyphenolic compounds: polyphenols or polyphenolic agents

- transepidermalna izguba vode: TEWL- Transepidermal water loss: TEWL

- minimalna eritemska doza: MED- minimum erythema dose: MED

Koža je največji organ človeškega telesa, ki pokriva skoraj celotno površino telesa. Sestavljajo jo epidermis, dermis in subcutis. Epidermis je na osnovi različnih faz v zorenju keratinocitov razdeljen v stratum basale, stratum spinosum, stratum granulosum, stratum lucidum in stratum corneum. V epidermisu so poleg osnovnih celic - keratinocitov prisotne še pigmentne celice (melanociti), antigen predstavitvene celice (Langerhansove celice), mehanoreceptorji (Merkelove celice).The skin is the largest organ of the human body, covering almost the entire surface of the body. It consists of the epidermis, dermis and subcutis. The epidermis is divided into stratum basale, stratum spinosum, stratum granulosum, stratum lucidum, and stratum corneum on the basis of different stages in keratinocyte maturation. In addition to the basic cells - keratinocytes, the epidermis also contains pigment cells (melanocytes), antigen presenting cells (Langerhans cells), mechanoreceptors (Merkel cells).

Dermis je čvrsta vezivna plast, ki daje koži mehanično odpornost (kolagen) in elastičnost (elastin, delno kolagen) oz. oboje (hialuronska kislina). Predvsem v zgornjem delu dermisa (papilarna plast) so prisotne še krvne žile, mezgovnice, živci in rahlo vezivo, izvodila znojnic ter središčni predeli lasnih foliklov, vključno z lojnicami. V dermisu sta dva pomembna žilna spleta: ob spodnji meji retikularna plast je globoki splet iz nekoliko večjih žil, tik pod epidermalno-dermalno mejo (papilarna plast) pa je povrhnji splet, v katerem prevladujejo venule in kapilare. Sestavni deli kože so še kožni adneksi - priveski (znojnice, dišavnice, lasni mešički, lojnice, dlake oz. lasje in nohti).The dermis is a firm bonding layer that gives the skin mechanical resistance (collagen) and elasticity (elastin, partially collagen) or. both (hyaluronic acid). Especially in the upper part of the dermis (papillary layer) are also present blood vessels, mucous membranes, nerves and a slight binder, sweat extractors and the central areas of the hair follicles, including sebaceous glands. There are two important vascular webs in the dermis: along the lower border, the reticular layer is a deep web of slightly larger veins, and just below the epidermal-dermal border (papillary layer) is the superficial web dominated by venules and capillaries. The skin components are also skin appendages - pendants (sweat, scents, hair follicles, sebaceous glands, hair or nails).

Koža je dokaj zapleten organ; posamezne plasti, celice, izvenceličnine, posamezne komponente - od različnih molekul z različnimi funkcijami, številnih encimov do genetskih materialov so med sabo povezani preko številnih soodvisnih signalnih procesov, biokemijskih in fizioloških procesov, s katerimi je regulirano delovanje kože ter njeni odzivi na intrinzične in ekstrinzične vplive.The skin is a fairly complex organ; individual layers, cells, extracellular components, individual components - from different molecules with different functions, many enzymes to genetic materials are interconnected through many interdependent signaling processes, biochemical and physiological processes that regulate skin function and its responses to intrinsic and extrinsic influences.

Različni zunanji in notranji dejavniki lahko pripomorejo k nastanku večjega števila prostih radikalov posledično pride do oksidativnega stresa. Tako je npr. posledica oksidativnega stresa lahko porušitev zapletenih dogajanj v obliki kaskad (preko katerih poteka npr. diferenciacija celic), pri katerih sodelujejo številne ti. signalne molekule. Prav tako lahko pride do okvar celičnih struktur (celične stene, organel, jedrne DNA idr.), kar se kaže kot pomanjkljiva sposobnost celic za tvorbo ključnih komponent za zagotavljanje ustrezne histološke zgradbe kože, in posledično slabše regeneracijske procese, čemur sledi poslabšanje lastnosti kože. Z zgradbo in vlogo kože pa so tesno povezana tudi bolezenska dogajanja v koži in spremembe na koži.Various external and internal factors can contribute to the formation of more free radicals, resulting in oxidative stress. Thus, e.g. oxidative stress can cause the collapse of complex events in the form of cascades (through which, for example, cell differentiation takes place), in which many are involved. signaling molecules. Damage to cell structures (cell walls, organelles, core DNA, etc.) can also occur, which is manifested as a lack of ability of cells to form key components to ensure proper histological structure of the skin, and consequently impaired regeneration processes, followed by deterioration of skin properties. The structure and role of the skin are also closely related to skin conditions and skin changes.

Različni dejavniki lahko torej vodijo do številnih neželenih sprememb kože, ki se kažejo kot npr.: zmanjšanje aktivnosti fibroblastov, ki vodi do zmanjšanja količine osnovnih strukturnih komponent ekstracelularnega matriksa (medceličnine) dermisa. Zaradi oslabljene funkcije teh komponent, posebno še v kombinaciji z neposrednimi poškodbami zaradi npr. prostihVarious factors can therefore lead to many unwanted skin changes, such as: a decrease in fibroblast activity leading to a decrease in the amount of basic structural components of the extracellular matrix (intercellular) of the dermis. Due to the weakened function of these components, especially in combination with direct damage due to e.g. free

radikalov, pride do sprememb vezivnega tkiva, kar se kaže kot nastanek gub, neenakomerne teksture kože, slabši elastičnosti, zmanjšani čvrstosti kože, večja je možnost nastanka brazgotin, strij ipd. Strukturne in fiziološke spremembe epidermisa prav tako lahko vodijo v poslabšanje zaščitne sposobnosti kože, povečanje prepustnosti in posledično vidnega luščenja, občutka zategovanja kože, rdečine, srbečice in izrazite suhosti kože. Posledice neželenih sprememb zgradbe oz. fizioloških procesov kože so lahko vidne tudi kot različne vrste hiperpigmentacij, teleangiektazije ipd.radicals, connective tissue changes, which is manifested as wrinkles, uneven skin texture, poorer elasticity, reduced skin firmness, greater chance of scarring, stretch marks and the like. Structural and physiological changes in the epidermis can also lead to a deterioration of the skin's protective capacity, increased permeability and, consequently, visible flaking, a sensation of tightening of the skin, redness, itching and marked dryness of the skin. The consequences of unwanted changes to the building or skin physiological processes can also be seen as different types of hyperpigmentation, teleangiectasia, and the like.

Omenjeni dejavniki lahko tudi vplivajo na razvoj novih ali poslabšanje že obstoječih bolezni kože kot so različni dermatitisi, luskavica, rozacea, akne, težave z lasiščem, kot na primer prhljaj, izguba las itd. Slabše je tudi celjenje ran in mikrocirkulacija, vnetni odziv kože in drugo.These factors can also influence the development of new or worsening pre-existing skin conditions such as various dermatitis, psoriasis, rosacea, acne, scalp problems such as dandruff, hair loss, etc. Wound healing and microcirculation, skin inflammatory response and more are also worse.

Za preprečevanje, lajšanje in zdravljenje se uporabljajo različne snovi in pripravki, ki kažejo na razširjenost problematik in veliko potrebo po tovrstnih pripravkih.Different substances and preparations are used to prevent, alleviate and treat, which indicate the prevalence of problems and the great need for such preparations.

Problem, ki doslej ni bil ustrezno rešen in ga z izumom rešujemo, so odprava oziroma zmanjševanje neželenih sprememb kože zaradi različnih intrinzičnih in ekstrinzičnih vzrokov, kot so biokemijske, fiziološke in strukturne spremembe v dermisu in epidermisu, ki se odražajo v zmanjšanju elastičnosti, gladkosti, mehkosti, vlažnosti, napetosti kože, spremembah pigmentacije, mikroreliefa, števila in velikosti por, sijaja, povečanju nagubanosti kože, slabšanju zaščitne bariere kože, spremembi pH površine kože ter drugih znakih, povečani občutljivosti na UV sevanje, spremembah strukture in funkcij lasišča, pa tudi v razvoju ali poslabšanju bolezni kože, kot so različni dermatitisi, luskavica, ulkusi, akne, rozacea in drugo.The problem that has not been properly solved so far and is solved by the invention is the elimination or reduction of unwanted skin changes due to various intrinsic and extrinsic causes, such as biochemical, physiological and structural changes in the dermis and epidermis, which are reflected in the reduction of elasticity, smoothness, softness, humidity, skin tension, changes in pigmentation, microrelief, number and size of pores, gloss, increase in skin wrinkling, deterioration of the protective barrier of the skin, change in the pH of the skin surface and other signs, increased sensitivity to UV radiation, changes in the structure and functions of the scalp, as well as in the development or exacerbation of skin diseases such as various dermatitis, psoriasis, ulcers, acne, rosacea and more.

Čeprav obstaja za reševanje navedenih težav vrsta različnih učinkovin in kozmetičnih in farmacevtskih pripravkov, obstaja stalna potreba po novih, bolj učinkovitih, zlasti pa naravnih učinkovinah in na njih temelječih pripravkih za preprečevanje, zmanjševanje oz.Although a variety of active ingredients and cosmetic and pharmaceutical preparations exist to address these problems, there is a continuing need for new, more effective, and especially natural, ingredients and preparations based on them for the prevention, reduction or reduction.

odpravljanje neželenih sprememb. Kljub trendu povečevanja potreb po na naravnih snoveh temelječih zdravilih za kožne bolezni je takšnih pripravkov na trgu na voljo relativno malo.eliminating unwanted changes. Despite the trend towards increasing the need for natural substance-based medicines for skin diseases, such preparations are relatively available on the market.

Problem predstavlja tudi dejstvo, da posamezne znane učinkovine delujejo na posamezen težave ali manjše število težav, zato so za različne namene potrebne različne učinkovine, za kompleksno obravnavo kože pa je potrebna v farmacevtskih in kozmetičnih pripravkih za topikalno uporabo kombinacija različnih učinkovin. Zato obstaja stalna potreba po novih, še zlasti naravnih učinkovinah s širšim spektrom delovanja oz. učinkov. Pri tem pa obstaja stalni problem, da mora učinkovina poleg učinkovitosti snovi kot take, izkazane in vitro, za dejansko učinkovitost v koži - in vivo - izkazovati tudi sposobnost penetracije snovi v kožo na mesto delovanja.Another problem is the fact that individual known active ingredients act on a single problem or a small number of problems, so different ingredients are needed for different purposes, and complex treatment of the skin requires a combination of different ingredients in pharmaceutical and cosmetic preparations for topical use. Therefore, there is a constant need for new, especially natural, substances with a broader spectrum of activity or. effects. However, there is a continuing problem that, in addition to the efficacy of the substance as such, demonstrated in vitro, for the effective efficacy in the skin - in vivo - it must also demonstrate the ability to penetrate the substance into the skin at the site of action.

Med snovmi, ki se uporabljajo v topikalnih pripravkih v zvezi s problemi kože so antioksidanti, v zadnjem času pa je pozornost usmerjena predvsem na polifenole.Antioxidants have been among the substances used in topical preparations for skin problems, and more recently, the focus has been on polyphenols.

Polifenoli so velika skupina spojin, katerih osnovni strukturni element je aromatski obroč z vsaj eno hidroksilno skupino. Hidroksilne skupine, ki so vezane na osnovi aromatski skelet, so lahko proste, zaestrene, zaetrene ali vezane na sladkor. Strukturno so zelo raznolike spojine, med njimi najdemo flavonoide, fenolne kisline, lignane, stilbene, pirone, ksantone, kinone, furano- in piranokumarine. Med nje štejemo tudi tanine oz. čreslovine, ki imajo adstringentni učinek.Polyphenols are a large group of compounds whose basic structural element is an aromatic ring with at least one hydroxyl group. Hydroxyl groups bound to the aromatic skeleton may be free, esterified, ethereal or sugar bound. Structurally, they are very diverse compounds, including flavonoids, phenolic acids, lignans, stilbene, pyrones, xanthones, quinones, furano and pyranocoumarins. It also includes tannins or tannins. scabs that have an astringent effect.

Za polifenole je značilno antioksidativno, za nekatere tudi antimikrobno delovanje, tanini pa delujejo tudi adstringentno. Antioksidativno delovanje temelji na fenolni skupini, ki lahko sprejme elektron in nastane stabilen fenoksi radikal, s čimer se prepreči oksidacija celičnih komponent. Polifenolne spojine zato delujejo kot lovilci prostih radikalov, predvsem reaktivnih kisikovih zvrsti (ROS) in s tem ščitijo celične lipide, proteine in DNA pred oksidativnimi poškodbami. Lahko tudi kelirajo kovinske ione, ki so udeleženi pri tvorbi radikalov, poleg tega pa lahko tudi povečajo aktivnost celičnih detoksifikacijskih sistemov (npr. katalaza, superoksidna dismutaza) ter zavrejo encime, ki generirajo ROS. Preko antioksidativnega delovanja ali preko inhibicije specifičnih proteinov (NF-kappaB, AP-1) lahko delujejo antiinflamatorno, preko inhibicije nekaterih interlevkinov pa lahko indirektno vplivajo na normalizacijo procesa proliferacije in diferenciacije epidermalnih bazalnih celic. Zaradi sposobnosti keliranja, delujejo sekvestracijsko in lahko tako uravnavajo aktivnost proteaz v dermisu, zlasti matriksmetaloproteinaz, ter uravnavajo oksidacijo tirozina, ki je del procesa melanogeneze, torej vplivajo na pigmentacijo kože. Z vplivom na aktivnost encimov iz skupine citikromov P450, cikloosigenaz in lipoksigenaz lahko nekateri polifenoli vplivajo na inhibicijo inflamatornih procesov ali regulacijo proliferativnih procesov in diferenciacije keratinocitov v epidermisu. Preko različnih mehanizmov delujejo tudi na krepitev žilnih sten. Delujejo tudi protimikrobno.Polyphenols are characterized by antioxidant activity, some by antimicrobial activity, and tannins also have an astringent effect. The antioxidant action is based on a phenolic group that can absorb the electron and produce a stable phenoxy radical to prevent oxidation of cellular components. Polyphenolic compounds therefore act as free radical scavengers, mainly reactive oxygen species (ROS), thereby protecting cell lipids, proteins and DNA from oxidative damage. They can also chelate metal ions involved in radical formation and can also increase the activity of cellular detoxification systems (eg catalase, superoxide dismutase) and inhibit ROS-generating enzymes. Through antioxidant activity or through inhibition of specific proteins (NF-kappaB, AP-1), they can act anti-inflammatory, and through the inhibition of some interleukins, they can indirectly affect the normalization of the proliferation and differentiation processes of epidermal basal cells. Due to their chelating ability, they act sequesteringly and can thus regulate the activity of proteases in the dermis, in particular matrix metalloproteinases, and regulate the oxidation of tyrosine, which is part of the melanogenesis process, thus affecting skin pigmentation. By affecting the activity of cytochrome P450 enzymes, cycloosigenases and lipoxygenases, some polyphenols may influence the inhibition of inflammatory processes or the regulation of proliferative processes and differentiation of keratinocytes in the epidermis. Through various mechanisms, they also act to strengthen the vascular walls. They also work antimicrobially.

Zaradi antikosidativnih lastnosti se v zadnjem času polifenoli uveljavljajo kot antioksidanti v obliki prehranskih dopolnil, in sicer predvsem polifenoli, ki se nahajajo v zelenem čaju, jagodičevju (maline, robidnice, borovnice), grozdju in rdečem vinu, kot dober vir antioksidantov pa so se izkazale tudi polifenolne učinkovine predvsem iz skorje nekaterih iglavcev. Med njimi je najbolj znan piknogenol (Pycnogenol®), ki je izvleček iz lubja francoskega obmorskega bora (Pinus pinaster). Vsebuje polifenolne komponente (katehin, taksifolin, procianidine z različno dolgimi verigami katehinskih in epikatehinskih enot in fenolne kisline), ki pri peroralni uporabi izkazujejo učinke proti kroničnim in degenerativnim boleznim, medtem ko je bilo raziskav o učinkih topikalne uporabe na koži razmeroma malo in le na živalih, med tem ko in vivo klinične študije učinkov topikalne uporabe piknogenola ali drugih podobnih izvlečkov iz iglavcev niso znani.Due to its antioxidant properties, polyphenols have recently been recognized as antioxidants in the form of dietary supplements, especially polyphenols found in green tea, berries (raspberries, blackberries, blueberries), grapes and red wine, and have proven to be good sources of antioxidants. also polyphenolic agents mainly from the bark of some conifers. Among them, the most famous is Pycnogenol®, which is an extract from the bark of the French seaside pine (Pinus pinaster). It contains polyphenolic components (catechin, taxifolin, procyanidins with different long chains of catechin and epicatechin units and phenolic acid), which show effects against chronic and degenerative diseases in oral administration, while relatively few and only limited studies have been performed on the effects of topical skin use. in animals, while in vivo clinical studies on the effects of topical use of pycnogenol or other similar conifer extracts are unknown.

Značilno za piknogenol je, da vsebuje razmeroma velik delež visokomolekularnih polifenolnih učinkovin, ki se slabo oz. ne absorbirajo iz črevesja, prav tako pa slabo oz. ne penetrirajo v kožo, kar je očitno razlog, da uporaba izvlečkov iz lesa ali skorje iglavcev za kozmetično in dermatološko uporabo v obliki pripravkov za topikalno uporabo še ni znana oz. nima dokazanih učinkov na kožo in vivo.Typical of pycnogenol is that it contains a relatively high proportion of high molecular weight polyphenolic substances which are poorly or efficiently. they do not absorb from the gut, as well as bad or. they do not penetrate the skin, which is obviously the reason why the use of wood extracts or bark of conifers for cosmetic and dermatological use in the form of preparations for topical use is not yet known or known. has no proven effects on skin in vivo.

Znani so tudi antioksidativni učinki izvlečka iz lesa bele jelke, kar je opisano v patentni prijavi Sl P-201400392 ter uporaba le-teh za zmanjševanje koncentracije postprandialne glukoze, kar je opisano v patentni prijavi Sl P-201500116, vendar pa doslej niso bili znani učinki le-tega na kožo, saj doslej še niso bile narejene in objavljene raziskave in vivo delovanja izvlečka iz lesa bele jelke na kožo niti živali niti ljudi.The antioxidant effects of the extract of white fir wood are also known, as described in patent application Sl P-201400392, and the use thereof for reducing postprandial glucose concentration, which is described in patent application Sl P-201500116, but no effects have been known so far. it has not yet been done and published to investigate the in vivo action of the extract of white fir tree on the skin of neither animals nor humans.

Izum bo pojasnjen v nadaljevanju opisa.The invention will be explained below in the description.

Izum se nanaša na izvleček iz lesa dreves iz rodu jelka (Abies), prednostno lesa bele jelke (Abies alba), zlasti še iz grč, ki vsebuje zmes naravnih polifenolov z zmanjšanim deležem visokomolekularnih polifenolov, in sicer za 15-100 % glede na celotno vsebnost naravnih polifenolov, ter z analogno povečanim deležem nizkomolekularnih polifenolov z molsko maso pod 1000 Da za preprečevanje, zmanjševanje oz. zdravljenje neželenih sprememb kože v kozmetični in dermatološki uporabi, in sicer izvlečka samega ali v obliki formuliranih kozmetičnih in farmacevtskih pripravkov za kozmetično in dermatološko uporabo.The invention relates to an extract from the tree of the tree of the genus Abies, preferably of the white fir tree (Abies alba), in particular of the spasms containing a mixture of natural polyphenols with a reduced proportion of high molecular weight polyphenols, by 15-100% over the total content of natural polyphenols, and with an analogous increase in the percentage of low molecular weight polyphenols with a molar mass below 1000 Da for the prevention, reduction or treatment of unwanted skin changes in cosmetic and dermatological use, whether extracted alone or in the form of cosmetic and pharmaceutical preparations for cosmetic and dermatological use.

Izvleček pridobimo z ekstrakcijo iz zmletega oz. zdrobljenega lesa dreves iz rodu jelka (Abies), prednostno iz lesa bele jelke (Abies alba), prednostno iz lesa vej, še bolj prednostno iz grč, torej iz dobro dostopne, odpadne surovine. Zdrobljeni oz. zmleti les segrevamo med mešanjem v vodi, prednostno pri temperaturi nad 80 °C, še bolj prednostno pri temperaturi vrelišča pri zunanjem tlaku ali pri povišanem tlaku pri temperaturi med temperaturo vrelišča in 150 °C. Vodno fazo ločimo s filtracijo, vodo pod znižanim tlakom deloma odparimo, in sicer na 1/10 -1/3 volumna, da dobimo koncentrat s koncentracijo izvlečka 2-10 ut. %. Koncentratu lahko dodamo trdni nosilec, kot npr. maltodekstrin, ciklodekstrin, celulozo, škrob ali njihove derivate za zmanjševanje skepljanja ter izboljšanje konsistence in stabilnosti, ter preostalo vodo v celoti odparimo in posušimo, da dobimo suho amorfno zmes oziroma trdno suho zmes. Trdnega nosilca dodamo 0-30 ut. % glede na suho snov izvlečka, prednostno 5-30 ut. %, še bolj prednostno 10-20 ut. %. Tako pridobljeni izvleček, ki vsebuje zmes naravnih polifenolov in je ali v obliki koncentrata ali v obliki trdne snovi, vsebuje od 10-80 ut. %, prednostno od 5080 ut. % naravnih polifenolov glede na suho snov izvlečka. Delež visokomolekularnih polifenolov v izvlečku je zmanjšan oziroma visokomolekularni polifenoli v izvlečku niso prisotni. Izvleček vsebuje povečani delež nizkomolekularnih polifenolov z molsko maso pod 1000 Da, kot so flavonoidi, fenolne kisline, lignani in drugi, in sicer od 50-100 % nizkomolekularnih polifenolov glede na celoten delež vseh naravnih polifenolov, prednostno od 80-100%.The extract is obtained by extraction from ground or. crushed wood of the Abies tree, preferably of the white fir tree (Abies alba), preferably of the branch tree, and more preferably of the shrubs, that is, of a well-accessible, waste material. Broken or the milled wood is heated by stirring in water, preferably at a temperature above 80 ° C, more preferably at a boiling point at ambient pressure or at elevated pressure at a temperature between boiling point and 150 ° C. The aqueous phase is separated by filtration, the water under reduced pressure is partially evaporated to 1/10 -1/3 volume to give a concentrate with a concentration of extract of 2-10 wt. %. A solid support such as e.g. maltodextrin, cyclodextrin, cellulose, starch or derivatives thereof to reduce build-up and improve consistency and stability, and evaporate the remaining water and dry completely to obtain a dry amorphous mixture or a solid dry mixture. The solid support is added 0-30 wt. % based on the dry matter of the extract, preferably 5-30 wt. %, more preferably 10-20 wt. %. The extract thus obtained, which contains a mixture of natural polyphenols and is either in the form of a concentrate or in the form of a solid, contains from 10-80 wt. %, preferably from 5080 wt. % of natural polyphenols relative to the dry matter of the extract. The percentage of high molecular weight polyphenols in the extract is reduced or high molecular weight polyphenols are not present in the extract. The extract contains an increased proportion of low molecular weight polyphenols with a molar mass below 1000 Da, such as flavonoids, phenolic acids, lignans and others, from 50-100% of low molecular weight polyphenols relative to the total proportion of all natural polyphenols, preferably from 80-100%.

Ker je delež visokomolekularnih polifenolov v izvlečku bistveno manjši in delež nizkomolekularnih polifenolov bistveno večji, kot v dosedaj znanih zmeseh oziroma izvlečkih iz iglavcev, je penetracija v kožo bistveno izboljšana.Since the percentage of high molecular weight polyphenols in the extract is much smaller and the proportion of low molecular weight polyphenols significantly higher than in the coniferous mixtures and extracts known to date, penetration into the skin is significantly improved.

Izvleček uporabimo ali v obliki koncentrata ali trdne suhe zmesi za dermalno uporabo neposredno ali v obliki tekočih, poltrdnih in trdnih pripravkov, kot so dermalne tekočine, vključno s pršili, kapljicami, šamponi in obkladki, dermalni praški (posipala), hidrofilni geli, hidrofilne kreme, hidrofobne kreme, mazila, paste, obliži in drugo.The extract can be used either in the form of a concentrate or solid dry mixture for dermal use directly or in the form of liquid, semi-solid and solid preparations such as dermal fluids, including sprays, drops, shampoos and compresses, dermal powders (sprinklers), hydrophilic gels, hydrophilic creams , hydrophobic creams, ointments, pastes, patches and more.

V kolikor se izvleček uporablja v obliki tekočih, poltrdnih in trdnih pripravkov, navedeni pripravki vsebujejo od 0,5-30 ut. % izvlečka glede na celotno maso pripravka, prednostno od 1-10 ut %, še bolj prednostno od 1-5 ut %.Insofar as the extract is used in the form of liquid, semi-solid and solid preparations, said preparations contain from 0.5-30% by weight. % extract based on the total weight of the preparation, preferably from 1-10 wt%, even more preferably from 1-5 wt%.

Poleg izvlečka pripravki oziroma kozmetične in dermatološke formulacije vsebujejo še različne pomožne snovi, ki so običajne v kozmetičnih in dermatoloških pripravkih, ter tudi druge biološko pomembne oz. aktivne snovi, za nevtralizacijo prostih radikalov, snovi za regeneracijo komponent epidermisa in dermisa, snovi za preprečevanje nastanka senescentnih celic, snovi za relaksacijo majhnih mišic, ki povzročajo gubanje kože, snovi, ki preprečujejo oz. uravnavajo tvorbo melanina. Te snovi so npr. vitamini, minerali, drugi antioksidanti, amino- in druge kisline, peptidi, proteini, saharidi, maščobe ter izvlečki in izločki iz rastlin, živali in tkivnih kultur le-teh, ki delujejo sinergistično z izvlečkom, ter tako dopolnijo ali ojačajo učinke predmetnega izvlečka.In addition to the extract, the preparations or cosmetic and dermatological formulations also contain various excipients that are common in cosmetic and dermatological preparations, as well as other biologically important or. active substances, to neutralize free radicals, substances to regenerate the components of the epidermis and dermis, substances to prevent the formation of senescent cells, substances to relax the small muscles that cause wrinkling of the skin, substances that prevent or prevent. regulate melanin formation. These substances are e.g. vitamins, minerals, other antioxidants, amino and other acids, peptides, proteins, saccharides, fats and extracts and extracts of plants, animals and tissue cultures that act synergistically with the extract to supplement or enhance the effects of the extract.

Z in vivo raziskavami učinkov izvlečka, ki vsebuje naravne polifenole, na kožo smo ugotovili številne presenetljive pozitivne učinke na spremembe v dermisu, epidermisu in na površini kože, ki se odražajo zlasti v stimulaciji tvorbe in regeneracije strukturnih proteinov, kot sta kolagen in elastin, ter posledično izboljšanju strukture dermisa, in stimulaciji regeneracijskih procesov, ki imajo za posledico izboljšanje stanja epidermisa. To se kaže v:In vivo studies of the effects of extracts containing natural polyphenols on the skin have revealed a number of surprising positive effects on changes in the dermis, epidermis and skin surface, which are reflected in particular in stimulating the formation and regeneration of structural proteins such as collagen and elastin, and consequently improving the structure of the dermis, and stimulating the regeneration processes that result in an improvement in the condition of the epidermis. This is reflected in:

- izboljšanju mikrocirkulacije, elastičnosti, gladkosti, mehkosti, vlažnosti, napetosti kože, mikroreliefa, sijaja, pH, zaščitne bariere in funkcije kože, odpornosti kože, npr. zmanjšanje eritemskega odziva na UV žarke, torej povečanje odpornosti pred učinki UV sevanja, celjenja ran in brazgotinjenja, strij, stanja lasišča in las, oteklin in zabuhlosti idr.,- improving microcirculation, elasticity, smoothness, softness, humidity, skin tension, microrelief, gloss, pH, protective barrier and skin function, skin resistance, e.g. Reduction of erythema response to UV rays, ie increase of resistance to the effects of UV radiation, wound healing and scarring, stretch marks, scalp and hair condition, swelling and swelling, etc.,

- zmanjšanju aken, nagubanosti, hiperpigmentacij, kot npr. lentigo senilis, lentigo Solaris, melazma, postvnetna in posttravmatska hiperpigmentacija, sončne pege, izraženosti teleangiektazij, vnetnih sprememb, nekaterih alergijskih in reaktivnih bolezni kože, idr.- reducing acne, wrinkling, hyperpigmentation, such as lentigo senilis, lentigo Solaris, melasma, post-inflammatory and post-traumatic hyperpigmentation, sunspots, expressions of teleangiectasis, inflammatory changes, some allergic and reactive skin diseases, etc.

In vivo raziskave so bile izvedene s kremo po izumu in placebo kremo. Relativni povprečni rezultati s kremo po izumu glede na placebo kremo kažejo:In vivo studies were performed with the cream of the invention and the placebo cream. The relative average results with the placebo cream according to the placebo cream show:

- zmanjšanje gub, in sicer volumna za 33 % in površine gub za 29%;- reduction of wrinkles by 33% volume and wrinkle area by 29%;

- 17 % izboljšanje vlažnosti;- 17% improvement in humidity;

- 19 % zmanjšanje TEVVL, kar kaže na bistveno izboljšanje stanja bariere kože;- a 19% reduction in TEVVL, indicating a significant improvement in the skin barrier condition;

- 13 % zmanjšanje retrakcijskega časa in 16 % povečanje viskoelastičnosti, kar kaže na bistveno povečanje elastičnosti kože;- a 13% reduction in retraction time and a 16% increase in viscoelasticity, indicating a significant increase in skin elasticity;

- 31 % povečanje intenzitete odboja ultrazvočnega signala dermisa, kar kaže izboljšanje strukture dermisa oz. stanja strukturnih proteinov - kolagena in elastina;- 31% increase in the reflection intensity of the dermis ultrasound signal, which indicates an improvement in the structure of the dermis or. states of structural proteins - collagen and elastin;

- 2 % povečanje debeline dermisa;- 2% increase in dermis thickness;

- 8 % povečanje minimalne eritemske doze (MED), kar kaže, da se izboljša fotozaščitna funkcija kože in njen odziv na UV sevanje ter zmanjšajo možnosti vnetnih reakcij;- an 8% increase in the minimum erythema dose (MED), which indicates that the photoprotective function of the skin and its response to UV radiation are improved and the chances of inflammatory reactions are reduced;

- prostovoljke so pozitivno ocenile učinke testne kreme v primerjavi s placebom praktično za vse parametre, ki niso bili v okvirih normalnega stanja;- the effects of the test cream compared to placebo were positively evaluated by volunteers for virtually all parameters not within the normal range;

- ekspertne ocene učinkov testne kreme so bile pozitivne praktično za vse parametre, ki niso bili v okvirih normalnega stanja.- Expert assessments of the effects of the test cream were positive for virtually all parameters outside the normal range.

Individualni odzivi so v odvisnosti od začetnega stanja še bistveno večji.Depending on the initial state, individual responses are even greater.

Dobljeni rezultati torej dokazujejo, da izvleček in pripravki, ki ga vsebujejo, presenetljivo vplivajo na številne lastnosti in funkcije kože, pri čemer se bistveno izboljšajo negativne spremembe na koži, med tem ko ne vpliva na normalna stanja kože. Hkrati je pomembno, da je izvleček naraven, s čimer izum sledi trendu povečane usmerjenosti na naravne sestavine, surovina pa je dejansko odpadni material pri predelavi lesa in zato lahko dostopna in cenena.The results obtained thus prove that the extract and the preparations it contains have a surprising effect on many skin properties and functions, significantly improving the negative changes in the skin, while not affecting normal skin conditions. At the same time, it is important that the extract is natural, whereby the invention follows the trend of increasing focus on natural ingredients, and the raw material is actually a waste material in wood processing and therefore easily accessible and inexpensive.

Predmetni izum rešuje problem učinkovite preventive, lajšanja in zdravljenja spremembe kože zaradi različnih intrinzičnih in ekstrinzičnih vzrokov, kot so biokemijske, fiziološke in strukturne spremembe v dermisu in epidermisu, ki se odražajo v zmanjšanju elastičnosti, gladkosti, mehkosti, vlažnosti, napetosti kože, spremembah pigmentacije, mikroreliefa, števila in velikosti por, sijaja, povečanju nagubanosti kože, slabšanju zaščitne bariere kože, spremembi pH površine kože ter drugih znakih, povečani občutljivosti na UV sevanje, spremembah strukture in funkcij lasišča, pa tudi v razvoju ali poslabšanju bolezni kože, kot so različni dermatitisi, luskavica, ulkusi, akne, rozacea in drugo.The present invention solves the problem of effective prevention, relief and treatment of skin changes due to various intrinsic and extrinsic causes, such as biochemical, physiological and structural changes in the dermis and epidermis, which are reflected in the reduction of elasticity, smoothness, softness, moisture, skin tension, pigmentation changes , microrelief, number and size of pores, glow, increase in wrinkling of skin, deterioration of protective barrier of skin, change in pH of skin surface and other signs, increased sensitivity to UV radiation, changes in structure and function of the scalp, as well as in the development or worsening of skin diseases such as various dermatitis, psoriasis, ulcers, acne, rosacea and more.

Izum pojasnjujejo, vendar ne omejujejo izvedbeni primeri.The invention is explained but not limited to the embodiments.

Za analize učinkov predmetne zmesi in pripravkov z njim na kožo smo uporabili naslednje aparature:The following apparatus was used to analyze the effects of the mixture and preparations with it on the skin:

- Cortex DermaLab Combo SkinLab - Cortex Technology ApS, Smedevaenget 10, 9560 Hadsund, Denmark; sonde za analizo dermisa (struktura/intenziteta in debelina dermisa), elastičnost, transepidermalno izgubo vode, vlažnost, barvo/rdečino/pigmentacije (CIE LAB)- Cortex DermaLab Combo SkinLab - Cortex Technology ApS, Smedevaenget 10, 9560 Hadsund, Denmark; dermis probes (structure / intensity and dermis thickness), elasticity, transepidermal water loss, humidity, color / redness / pigmentation (CIE LAB)

- VisioFace Quick (VFQ), round shaped model - Courage&Khazaka electronic GmbH, Mathias BrOggen-Str. 91,50829 Cologne, Germany (za fotoanalize)- VisioFace Quick (VFQ), round shaped model - Courage & Khazaka electronic GmbH, Mathias BrOggen-Str. 91,50829 Cologne, Germany (for photoanalysis)

- Dr. Hoenle Dermalight 80 MED-Tester (za določanje minimalne eritemske doze odziva na UV žarke)- Dr. Hoenle Dermalight 80 MED-Tester (to determine the minimum erythema dose of UV response)

- DermaScope MEDL4D, Dino-Lite, Netherlands (vizualne analize)- DermaScope MEDL4D, Dino-Lite, Netherlands (visual analysis)

- Multi Skin Test center - Courage&Khazaka electronic GmbH, Mathias Bruggen-Str. 91, 50829 Cologne (sonde za vlažnost, elastičnost, pH, TEWL, rdečino, pigmentacijo/melanin)- Multi Skin Test Center - Courage & Khazaka electronic GmbH, Mathias Bruggen-Str. 91, 50829 Cologne (probes for humidity, elasticity, pH, TEWL, redness, pigmentation / melanin)

Primer 1 - priprava koncentrata izvlečka in trdne suhe zmesi izvlečka iz lesa bele jelke kg zdrobljenih vej bele bele jelke (Abies alba), ki je ena izmed vrst iz rodu jelk (Abies sp.) smo prelili s 5 L vrele deionizirane vode in med mešanjem segrevali pri temperaturi vrelišča še 20 min. Vzorce smo nato filtrirali pod znižanim tlakom ter vodni izvleček posušili s kombinacijo sušenja z rotavaporjem in liofilizatorjem. Ko je bil volumen zmanjšan na ca 1/3, smo odvzeli 0,5 L raztopine, da smo dobili koncentrirano raztopino izvlečka s koncentracijo približno 3 %, preostanku pa dodali ca 10 % maltodekstrina (izraženo kot delež maltodekstrina na suho maso izvlečka) in zmes posušili. Tako pripravljeno koncentrirano raztopino izvlečka in trdno suho zmes izvlečka smo uporabili za analize, pripravo formuliranih pripravkov ter izvedbo in vivo študij.Example 1 - Preparation of extract concentrate and solid dry blend of white fir tree kg of crushed branches of white white fir (Abies alba), which was one of a kind of fir tree (Abies sp.), Was poured with 5 L of boiling deionized water and stirred heated at boiling point for another 20 min. Samples were then filtered under reduced pressure and the aqueous extract was dried by a combination of rotavapor drying and a lyophilizer. When the volume was reduced to ca 1/3, 0.5 L of solution was withdrawn to obtain a concentrated extract solution at a concentration of about 3% and to the residue was added about 10% maltodextrin (expressed as a percentage of maltodextrin by dry weight of the extract) and the mixture dried. Both the concentrated extract solution and the solid dry mixture of the extract were used for analyzes, preparation of formulated preparations and in vivo studies.

Izvedli smo analize z barvnimi reakcijami za določanje polifenolov, metodo kožnih praškov (določitev deleža visokomolekularnih polifenolov) in s HPLC (mobilna faza A: voda, 0,1 % TFA, mobilna faza B: acetonitril; gradient: B (0-1 min 5% B, 1-10 min 5-30% B, 10-15 min 100% B, pretok mobilne faze 2 ml/min; 20 pl vzorca). Analize so pokazale ca. 60 % polifenolov v suhi snovi, od tega ca 90 % nizkomolekularnih polifenolov z molsko maso pod 1000 Da, pretežno fenolne kisline, flavonoide in lignane.Analyzes were performed with color reactions for the determination of polyphenols, the method of skin powders (determination of the percentage of high molecular weight polyphenols) and by HPLC (mobile phase A: water, 0.1% TFA, mobile phase B: acetonitrile; gradient: B (0-1 min 5 % B, 1-10 min 5-30% B, 10-15 min 100% B, mobile phase flow 2 ml / min; 20 pl of sample) Analyzes showed about 60% of polyphenols in dry matter, of which about 90 % of low molecular weight polyphenols with a molecular weight below 1000 Da, predominantly phenolic acids, flavonoids and lignans.

Primer 2 - kremaExample 2 - Cream

Sestavina Ingredient Količina sestavine v 100 g pripravka Amount of ingredient in 100 g preparation Faza a Phase a Lanette N Lanette N 5,00 5,00 Stearinska kislina Stearic acid 3,50 3.50 Cetanol Cetanol 0,50 0.50 Tegosoft CT Tegosoft CT 3,00 3.00 Marelično olje Apricot oil 8,00 8,00 Cetiol SN Cetiol SN 2,00 2.00 TiO2 TiO 2 0,20 0.20 Parafinsko olje Paraffin oil 1,00 1.00 Faza b Phase b Voda demineralizirana Water demineralized 68,10 68,10 Glicerol Glycerol 3,00 3.00 Urea Urea 1,00 1.00 Phenonip Phenonip 0,50 0.50 izvleček iz primera 1 extract from Example 1 2,00 2.00 Faza c Phase c Voda demineraliziraa Water demineralizes 2,00 2.00 TEA TEA 0,20 0.20 Faza d Phase d Dišava Fragrance 0,20 0.20

V 400 ml čašo smo natehtali surovine faze a ter v 200 ml čašo surovine faze b in obe fazi segreli na 75°C. Nato smo segreti fazi združili tako, da smo med mešanjem z električnim mehanskim mešalom dodali vodno fazo v oljno. V 20 ml čašo smo natehtali demineralizirano vodo in TEA - faza c, dobro premešali, da smo dobili bistro raztopino in dodali k zmesi faze a in b. Mešali smo nekaj minut, nato smo dodali še fazo d. Dobljeno emulzijo smo med stalnim mešanjem ohladili na sobno temperaturo, ter dobljeno kremo z vsebnostjo 2 % izvlečka prenesli v embalažo. Kremo smo uporabili za in vivo študijo učinkov.Phase a raw materials were weighed into a 400 ml beaker and phase b raw material in a 200 ml beaker and both phases were heated to 75 ° C. We then combined the heated phases by adding the aqueous phase to the oil while stirring with an electric mechanical stirrer. Demineralized water and TEA - phase c were weighed into a 20 ml beaker, mixed well to obtain a clear solution and added to the mixture of phases a and b. We stirred for a few minutes, then added phase d. The resulting emulsion was cooled to room temperature while stirring constantly, and the resulting cream containing 2% extract was transferred to the package. The cream was used for an in vivo effect study.

Primer 3 - in vivo študija učinkov na kožo prostovoljk, starih 45-65 let, fototip II in III, z različnimi spremembami oz. stanji kože, je 12 tednov nanašalo kremo iz Primera 2 na polovico obraza ter polovico glutealnega dela 2-krat dnevno, na drugo polovico pa placebo kremo, sicer pripravkov, ki so jih do začetka študije in režima niso spreminjale. Prostovoljke so podpisale informirane pristanke, študijo je odobrila pristojna Etična komisija. Z meritvami, fotoanalizami, ekspertnimi ocenami in samoocenami smo analizirali stanje kože na začetku (1 dan pred začetkom nanašanja kreme - 1. termin), po 6 tednih (2. termin) in 12 tednih (3. termin). Rezultati so prikazani v Tabelah 1,2 in 3.Case 3 - an in vivo study of the skin effects of volunteers aged 45-65 years, phototype II and III, with various changes or changes. for 12 weeks applied the cream from Example 2 to half of the face and half of the gluteal portion twice a day and the other half to placebo cream, otherwise preparations that were not altered by the start of the study and regimen. Volunteers signed informed consent, the study was approved by the responsible Ethics Committee. Measurements, photo-analyzes, expert assessments and self-assessments were used to analyze the skin condition at the beginning (1 day before the start of the application of the cream - 1st term), after 6 weeks (2nd term) and 12 weeks (3rd term). The results are shown in Tables 1,2 and 3.

Tabela 1: Povprečna absolutna in relativna sprememba volumna in površine gub v lateralnem periorbitalnem delu očesa (Crow's feet) med 1. (pred uporabo kreme) in 3. terminom meritev (po 12 tednih uporabe krem) na desnem (testna krema, 2% predmetne zmesi) in levem licu (placebo krema)Table 1: Mean absolute and relative changes in volume and area of wrinkles in the lateral periorbital part of the eye (Crow's feet) between the 1st (before applying the cream) and the 3rd measurement period (after 12 weeks of applying the cream) to the right (test cream, 2% of the subject mixture) and left cheek (placebo cream)

DESNO LICE - krema RIGHT FACE - cream LEVO LICE - p LEFT FACE - p acebo acebo Sprememba med 1. in 3. terminom Change between 1st and 3rd term Relativna sprememba med 1. in 3. terminom (%) Relative change between 1st and 3rd term (%) Sprememba med 1. in 3. terminom Change between 1st and 3rd term Relativna sprememba med 1. in 3. terminom (%) Relative change between 1st and 3rd term (%) GUBA/VOLUMEN (px3) LOSS / VOLUME (px3) -9581,3 -9581,3 -16,7 -16.7 4884,5 4884,5 16,4 16.4 GUBA/POVRŠINA (px2) LOSS / SURFACE (px2) -1037,1 -1037.1 -22,3 -22.3 134,5 134.5 7,6 7,6

Tabela 2: Povprečna absolutna in relativna sprememba vlažnosti, elastičnega modula (E), viskoelastičnosti (VE) in refrakcije (parametra elastičnosti kože), transepidermalne izgube vode (TEWL), debeline in intenzitete dermisa med 1. (pred uporabo krem) in 3. terminom meritev (po 12 tednih uporabe krem) na desnem (testna krema, 2% predmetne zmesi) in levem licu (placebo krema).Table 2: Average absolute and relative changes in humidity, elastic modulus (E), viscoelasticity (VE) and refraction (skin elasticity parameter), transepidermal water loss (TEWL), dermis thickness and intensity between 1. (before applying creams) and 3. measurement term (after 12 weeks of cream use) on the right (test cream, 2% of the subject mixture) and left cheek (placebo cream).

DESNO LICE-krema RIGHT FACE CREAM LEVO LICE- placebo LEFT FACE- placebo Sprememba med 1. in 3. terminom Change between 1st and 3rd term Relativna sprememba med 1. in 3. terminom Relative change between 1st and 3rd term Sprememba med 1. in 3. terminom Change between 1st and 3rd term Relativna sprememba med 1. in 3. terminom Relative change between 1st and 3rd term Vlažnost Humidity 42,9 pS 42.9 pS 27,2 % 27.2% 15,6 pS 15.6 pS 9,6 % 9,6% VE VE 0,3 MPa 0.3 MPa 38,2 % 38.2% 0,1 MPa 0.1 MPa 22,0 % 22,0% retrakcija retraction -866,5 ms -866.5 ms -23,2 % -23.2% -522,4 ms -522.4 ms -9,8 % -9.8% TEWL TEWL -2,6 g/cm2/h-2.6 g / cm 2 / h -19,4 % -19.4% -0,1 g/cm2/h-0.1 g / cm 2 / h -0,7 % -0.7% debelina dermisa thickness dermis 38,8 μιη 38,8 μιη 3,6 % 3.6% 15,1 pm 15,1 pm 1,6 % 1.6% intenziteta dermisa (indeks 0-100) intensity dermis (index 0-100) 3,5 3.5 18,4 % 18,4% -3,2 -3,2 -12,6 % -12.6%

Tabela 3. Izboljšanje fotozaščitne funkcije kože - spremembe minimalne eritemske doze (MED)Table 3. Improvement of photosensitive skin function - changes in minimum erythema dose (MED)

desno lice - krema right face - cream levo lice - placebo left face - placebo MED 1. termin (J/cm2)HONEY 1st term (J / cm 2 ) MED 3. termin (J/cm2)MED 3rd term (J / cm 2 ) sprememba MED med 1. in 3. terminom (J/cm2)change of MED between 1st and 3rd term (J / cm 2 ) relativna sprememba MED med 1. in 3. terminom (%) relative change MED between 1 and 3rd term (%) MED 1. termin (J/cm2)HONEY 1st term (J / cm 2 ) MED 3. termin (J/cm2)MED 3rd term (J / cm 2 ) sprememba MED med 1. in 3. terminom (J/cm2)change of MED between 1st and 3rd term (J / cm 2 ) relativna sprememba MED med 1. in 3. terminom (%) relative change MED between 1 and 3rd term (%) 0,64 0.64 0,69 0.69 0,06 0.06 10,17 10.17 0,64 0.64 0,65 0.65 0,01 0.01 1,67 1.67

Primer 4 - zmanjšanje gubExample 4 - Wrinkle reduction

Prostovoljka, stara 45 let, je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Analiza izbranih gub v lateralnem periorbitalnem delu oči (Crow's feet) je pokazala zmanjšanje globine gub za 50 % ter površine za 48 % glede na placebo.The 45-year-old volunteer used 12 weeks of Case 2 cream and placebo cream as indicated in Example 3. Analysis of selected wrinkles in the lateral periorbital part of the eye (Crow's feet) showed a reduction in wrinkle depth of 50% and area of 48% according to placebo.

Primer 5 - povečanje elastičnosti in vlažnosti ter zmanjšanje izraženosti teleangiektazij in kuperozeExample 5 - Increase in elasticity and humidity and decrease in teleangiectasia and couperose

Prostovoljka, stara 51 let, s izrazito suho kožo v predelu nosu, širšega območja lic in brade, z izraženimi teleangiektazijami v centralnem področju ter izraženo kuperozo, je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Analiza rezultatov meritev elastičnosti kože je pokazala izboljšanje viskoelastičnosti (VE) za 58%, izboljšanje elastičnega module E za 5%, izboljšanje vlažnosti pa za 30% glede na placebo ter opazno zmanjšanje izraženosti teleangiektazij in kuperoze.A volunteer, 51 years old, with pronounced dry skin in the nasal area, wider area of the cheeks and chin, with pronounced teleangiectasia in the central area and pronounced cuprose, used 12 weeks of Example 2 cream and placebo cream as indicated in Example 3. Analysis The results of skin elasticity measurements showed a 58% improvement in viscoelasticity (VE), a 5% improvement in the elastic modulus, and a 30% improvement in humidity relative to placebo, and a marked decrease in the expression of teleangiectasis and couperose.

Primer 6 - povečanje elastičnosti kožeExample 6 - Increasing skin elasticity

Prostovoljka, stara 54 let, z izrazito slabo gladkostjo kože, izraženim mikroreliefom in slabo elastičnostjo kože, je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Analiza rezultatov meritev elastičnosti kože je pokazala izboljšanje časa, potrebnega za retrakcijo kože za 13% glede na placebo, izrazito se je izboljšal mikrorelief in gladkost kože.A 54-year-old volunteer with extremely poor skin smoothness, pronounced microrelief, and poor skin elasticity used 12 weeks of Example 2 cream and placebo cream as indicated in Example 3. Analysis of the results of skin elasticity measurements showed an improvement in the time required for skin retraction by 13% relative to placebo, markedly improved microrelief and smoothness of the skin.

Primer 7 - izboljšanje strukture dermisa in izboljšanje bariere kožeExample 7 - Improvement of dermis structure and improvement of skin barrier

Prostovoljka, stara 50 let, z znaki staranja kože in mimičnimi gubami ter poslabšano bariero kože (povečan TEWL), je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Analiza rezultatov meritev strukture dermisa in TEWL je pokazala povečanje intenzitete odziva ultrazvočnega signala (izboljšanje stanja strukturnih proteinov - kolagena in keratina) za 84 % ter zmanjšanje transepidermalne izgube vode (izboljšanje zaščitne funkcije kože) za 26 % glede na placebo.A volunteer, 50 years old, with signs of skin aging and facial wrinkles, and a deteriorated skin barrier (increased TEWL), used 12 weeks of Example 2 cream and a placebo cream as indicated in Example 3. Analysis of the results of dermis and TEWL measurements showed an increase in the intensity of the response of the ultrasound signal (improvement of the state of structural proteins - collagen and keratin) by 84% and a decrease in transepidermal water loss (improvement of the protective function of the skin) by 26% relative to placebo.

Primer 8 - povečanje debeline dermisaExample 8 - Increase in dermis thickness

Prostovoljka, stara 64 let, s fotopoškodovano kožo, izraženimi sončnimi pegami (ephelides) in gubami po morfotipu pečenega jabolka, kadilka, z izrazito slabim stanjem demrisa, je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno vA volunteer, 64 years old, with photo-damaged skin, pronounced ephelides and wrinkles according to the morphotype of a roasted apple, a smoker with a severely debilitating condition used a 12-week Case 2 cream and a placebo cream as indicated in

Primeru 3. Analiza rezultatov meritev strukture dermisa je pokazala povečanje debeline dermisa za 16 % glede na placebo.Example 3. Analysis of the results of dermis structure measurements showed a 16% increase in dermis thickness relative to placebo.

Primer 9 - povečanje minimalne eritemske dozeExample 9 - Increase in the minimum erythema dose

Prostovoljka, stara 54 let, fototip III, je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Analiza rezultatov meritev minimalne eritemske doze je pokazala, da je za nastanek rdečine potrebna 12 % večja doza UV sevanja, kot pred začetkom uporabe, medtem ko pri uporabi placebo kreme ni bilo spremembe.The 54-year-old volunteer, Phototype III, used a 12-week cream from Example 2 and a placebo cream as indicated in Example 3. Analysis of the results of the minimum erythema dose measurements showed that a reddish 12% higher dose of UV was required to produce redness, as before use, whereas there was no change in the use of placebo cream.

Primer 10 - posvetlitev hiperpigmentacijExample 10 - Lightening hyperpigmentation

Prostovoljka, stara 55 let, fototip II, z izrazitimi hiperpigmentacijami - solarnimi lentigi v lateralnem periorbitalnem delu obraza je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Izmerili smo barvo (E) in svetlost (L) mesta s hiperpigmentacijo - solarnimi lentigi in mesta poleg njih; rezultati so prikazani v tabeli 4.Volunteer 55 years old, phototype II, with marked hyperpigmentation - solar lentigas in the lateral periorbital part of the face used 12 weeks cream from Example 2 and placebo cream as indicated in Example 3. We measured color (E) and brightness (L) sites with hyperpigmentation - solar lentiges and sites adjacent to them; the results are shown in Table 4.

Tabela 4. Rezultati meritev pigmentacije: AL - razlika svetlosti L med hiperpigmentacijo in mesta poleg nje; relativna sprememba AL - relativna sprememba AL med 1. in 3. terminom (po 12 tednih uporabe kreme); ΔΕ - razlika v barvi E med hiperpigmentacijo in mestom poleg nje; relativna sprememba ΔΕ - relativna sprememba ΔΕ med 1. in 3. terminom (po 12 tednih uporabe kreme).Table 4. Results of pigmentation measurements: AL - L brightness difference between hyperpigmentation and adjacent sites; relative AL change - relative AL change between 1st and 3rd term (after 12 weeks of cream application); ΔΕ - the difference in color E between hyperpigmentation and the site next to it; relative change of ΔΕ - relative change of ΔΕ between the 1st and 3rd term (after 12 weeks of applying the cream).

AL AL ΔΕ ΔΕ Termin 1 Term 1 Termin 3 Term 3 Termin 1 Term 1 Termin 3 Term 3 relativna sprememba AL relative change in AL relativna sprememba ΔΕ relative change ΔΕ DESNO LICE krema RIGHT FACE CREAM -7,12 -7,12 -2,66 -2.66 8,81 8.81 2,95 2.95 -62,6 (%) -62.6 (%) -66,5 (%) -66.5 (%) LEVO LICE Placebo LEFT FACE Placebo -2,70 -2,70 -3,71 -3.71 6,07 6.07 5,31 5.31 37,4 (%) 37.4 (%) -12,5 (%) -12.5 (%)

Analiza rezultatov meritev pigmentacije je pokazala bistveno posvetlitev ter spremembo barv, in sicer se je hiperpigmentacija posvetlila za ca 63 % glede na mesto poleg nje, glede na rezultate za placebo pa kar za 100 %, prav tako se je zmanjšala razlika v barvi med hiperpigmentaicjo in mestom poleg nje za 66% (medtem ko je ta razlika za placebo le ca 12 %).Analysis of the results of pigmentation measurements showed a significant lightening and color change, with hyperpigmentation brightening by about 63% relative to the site next to it and by placebo results by as much as 100%, as well as reducing the color difference between hyperpigmentation and places next to it by 66% (while this placebo difference is only ca 12%).

Primer 11 - zmanjšanje površine hiperpigmentaciiExample 11 - reduction of the surface of hyperpigmentation

Prostovoljka, stara 45 let, fototip III, z izrazitimi starostnimi hiperpigmentacijami v lateralnem periorbitalnem delu obraza je uporabljala 12 tednov kremo iz Primera 2 ter placebo kremo, kot je navedeno v Primeru 3. Prostovoljka se je med izvajanjem študije občasno izpostavljala soncu, zato je prišlo do potemnitve kože. Izmerili smo površino izbranih hiperpigmentacij. Rezultati so prikazani v Tabeli 5.The volunteer, 45 years old, Phototype III, with pronounced age-related hyperpigmentation in the lateral periorbital part of the face, used the 12-week cream from Example 2 and the placebo cream, as indicated in Example 3. The volunteer occasionally exposed herself to the sun, to skin darkening. The surface area of the selected hyperpigmentations was measured. The results are shown in Table 5.

Tabela 5. Površine izbranih hiperpigmentacij pred in po uporabi kreme in placeba.Table 5. Surfaces of selected hyperpigmentations before and after the use of cream and placebo.

PIGMENTACIJA površina PIGMENTATION of surfaces 1. termin (px) 1st term (px) 3. termin (px) 3rd term (px) Sprememba med 1. in 3. terminom (px2) Change between 1st and 3rd term (px2) Relativna sprememba površine med 1. in 3. terminom (%) Relative surface change between 1st and 3rd term (%) desno krema right cream 8,72 8.72 2,8 2.8 -6,0 -6.0 -68,3 -68.3 levo placebo left placebo 11,61 11,61 16,1 16.1 4,5 4.5 38,3 38,3

Iz Tabele 5 je razvidno izrazito zmanjšanje površine hiperpigmentacije po uporabi kreme (za 68 %), medtem ko je pri uporabi placeba prišlo celo do povečanja za 38 %, kar je posledica izpostavljanja soncu oz. UV žarkom. Razlike v rezultatih za kremo in placebo kažejo poleg učinkovitosti predmetne zmesi tudi na povečanje zaščitne funkcije kože in zmanjšanja podvrženosti nastajanju hiperpigmentacij.Table 5 shows a marked decrease in the area of hyperpigmentation after the use of the cream (by 68%), while the use of placebo even showed an increase of 38% as a result of exposure to the sun and the sun. UV rays. The differences in the results for cream and placebo indicate, in addition to the effectiveness of the composition in question, an increase in the protective function of the skin and a decrease in the susceptibility to hyperpigmentation.

Primer 12 - kompleksna krema z dodatnimi učinkovinamiExample 12 - A complex cream with additional active ingredients

Sestava:Composition:

Sestavina Ingredient Količina sestavine v 100 g pripravka Amount of ingredient in 100 g preparation Faza a Phase a Myritol 318 Myritol 318 7,00 7,00 Lanette O Lanette O 2,50 2.50 Mandljevo olje Almond oil 5,00 5,00 DC 245 DC 245 1,5 1.5 Mikrokapsule s skvalanom Squalane microcapsules 0,015 0.015 Faza b Phase b Demi voda Demi water 60,10 60.10 EDTA EDTA 0,8 0.8 Emulgade F special Emulgade F special 1,5 1.5 Glicerin Glycerin 5,00 5,00 Phenonip Phenonip 0,50 0.50 Faza c Phase c Ksantan gumi Xanthan gum 0,20 0.20 Voda Water 10,00 10,00 Faza d Phase d Hidroviton Hydroviton 1,00 1.00 Aloe barbadensis ekstrakt Aloe barbadensis extract 3,00 3.00 izvleček iz Primera 1 extract from Example 1 1,50 1.50 Vitamin E acetat Vitamin E acetate 0,10 0.10 Mlečni proteini Milk proteins 1,00 1.00 Faza e Phase e NaOH NaOH po potrebi if necessary

Priprava faze c): V 40 ml čašo natehtamo 10 g destilirane vode. Za tem posebej natehtamo 0,20 g Ksantan gumi in ga dodamo v čašo. Mešamo s stekleno paličko približno 10 minut, da se Ksantan gumi raztopi. Priprava faze b): V 400 g čašo natehtamo 60,10 g destilirane vode. Nato v čašo dodamo 0,8 g EDTA. Mešamo s stekleno palčko, da se EDTA raztopi. Nato dodamo še 1,5 g Emulgade F special. Fazi b nato dodamo še 5,00 g Glicerola in 0,5 g Phenonipa. Vse skupaj premešamo in damo segrevati na vodno kopel. Priprava faze a): V 250 ml čašo zaporedoma natehtamo 7 g Myritol 318 (Tegosoft CT), 2,5 g Lanette O, 5 g Mandljevega olja, 1,5 g DC 245 in 0,015 g Mikrokapsul s skvalanom. Čašo z mešanico vseh dodanih sestavin segrevamo na vodni kopeli. Med segrevanjem vodne in oljne faze na vodni kopeli konstantno spremljamo njihovo temperaturo. Ko dosežeta obe fazi temperaturo 78-80° C, odstranimo čaše iz vodne kopeli in vsebino čaše vodno fazo začnemo mešati z mehanskim mešalom. Oljno fazo a nato počasi dodajamo vodni fazi pri konstantni hitrosti mešanja. Med mešanjem emulzije si pripravimo še fazo d). Priprava faze d): Ko pade temperatura emulzije na 38° C, ji dodamo po vrsti zgoraj naštete učinkovine faze d. Emulzijo še nekaj časa mešamo pri konstantni hitrosti.Preparation of phase c) Weigh 10 g of distilled water into a 40 ml beaker. After that, 0.20 g of xanthan gum is weighed separately and added to the beaker. Mix with glass rod for about 10 minutes to dissolve the xanthan gum. Preparation of phase b): Weigh 60.10 g of distilled water into a 400 g beaker. 0.8 g EDTA was then added to the beaker. Mix with a glass rod to dissolve EDTA. Then add 1.5 g of Emulgade F special. 5.00 g of glycerol and 0.5 g of Phenonip were then added to phase b. Mix everything and bring to a boil. Preparation of phase a): Weigh, in succession, 7 g of Myritol 318 (Tegosoft CT), 2.5 g of Lanette O, 5 g of almond oil, 1.5 g of DC 245 and 0.015 g of squalane microcapsules in succession. Heat the beaker with a mixture of all the ingredients added in a water bath. During the heating of the water and oil phases, the temperature of the water bath is constantly monitored. When both phases reach a temperature of 78-80 ° C, remove the beakers from the water bath and start mixing the contents of the beaker with the mechanical stirrer. The oil phase a is then slowly added to the aqueous phase at a constant mixing rate. Phase d) is prepared while mixing the emulsion. Preparation of phase d): When the emulsion temperature drops to 38 ° C, it is added in the order of the above-mentioned phase d active ingredient. The emulsion was stirred at constant speed for some time.

Tako dobimo kremo, ki vsebuje poleg izvlečka še druge učinkovine, ki delujejo sinergistično z izvlečkom in s tem povečajo učinke izvlečka.Thus, a cream is obtained which contains, in addition to the extract, other active ingredients which act synergistically with the extract, thereby increasing the effects of the extract.

Claims (12)

1. Izvleček iz lesa dreves iz rodu jelka, prednostno iz lesa bele jelke, ki vsebuje naravne polifenole za uporabo za preventivo, lajšanje in zdravljenje sprememb kože obraza, telesa in lasišča, ki so posledica biokemijskih, fizioloških in strukturnih sprememb v dermisu in epidermisu.1. Extract from the tree of a tree of the genus fir tree, preferably of a white fir tree containing natural polyphenols for use in preventing, alleviating and treating changes in the skin of the face, body and scalp resulting from biochemical, physiological and structural changes in the dermis and epidermis. 2. Izvleček po zahtevku 1 za uporabo za stimulacijo tvorbe in regeneracije strukturnih proteinov, kot sta kolagen in elastin, za izboljšanje strukture dermisa, za stimulacijo regeneracijskih procesov, ki imajo za posledico izboljšanje stanja epidermisa.2. The extract of claim 1 for use to stimulate the formation and regeneration of structural proteins, such as collagen and elastin, to improve dermis structure, to stimulate regenerative processes that result in an improvement in the status of the epidermis. 3. Izvleček po zahtevkih 1 in 2 za uporabo za izboljšanje mikrocirkulacije, elastičnosti, gladkosti, mehkosti, vlažnosti, napetosti kože, mikroreliefa, sijaja, pH, zaščitne bariere in odpornosti kože, za zmanjšanje aken, nagubanosti in hiperpigmentacij in za zdravljenje dermatitisa, luskavice, ulkusov in rozacee.Extract according to claims 1 and 2 for use for improving microcirculation, elasticity, smoothness, softness, humidity, skin tension, microrelief, gloss, pH, protective barrier and skin resistance, for reducing acne, wrinkling and hyperpigmentation and for treating dermatitis, psoriasis , ulcers and rosacea. 4. Izvleček po zahtevkih od 1 do 3, označen s tem, da je vsebnost naravnih polifenolov od 10-80 ut. %, prednostno od 50-80 ut. % glede na suho snov izvlečka in je delež nizkomolekularnih polifenolov z molsko maso pod 1000 Da od 50-100 % glede na celoten delež vseh naravnih polifenolov, prednostno od 80-100%.Extract according to claims 1 to 3, characterized in that the content of natural polyphenols is from 10-80 wt. %, preferably from 50-80 wt. % based on the dry matter of the extract and the proportion of low molecular weight polyphenols with a molecular weight below 1000 Da is from 50-100% relative to the total proportion of all natural polyphenols, preferably from 80-100%. 5. Izvleček po zahtevkih od 1 do 4, označen s tem, da so nizkomolekularni polifenoli z molsko maso pod 1000 Da prednostno flavonoidi, fenolne kisline in lignani.Extract according to claims 1 to 4, characterized in that the low molecular weight polyphenols with a molecular weight of less than 1000 Da are preferably flavonoids, phenolic acids and lignans. 6. Izvleček po zahtevkih od 1 do 5, označen s tem, da se uporablja v obliki koncentrirane vodne raztopine s koncentracijo izvlečka od 2 do 10% ali v obliki trdne suhe zmesi.Extract according to claims 1 to 5, characterized in that it is used in the form of a concentrated aqueous solution with a concentration of the extract of 2 to 10% or in the form of a solid dry mixture. 7. Kozmetični in dermatološki pripravki, označeni s tem, da vsebujejo izvleček po zahtevkih od 1 do 6.7. Cosmetic and dermatological preparations, characterized in that they contain an extract according to claims 1 to 6. 8. Pripravki po zahtevku 7, označeni s tem, da vključujejo od 0,5-30 ut. % izvlečka glede na celotno maso pripravka, prednostno od 1-10 ut %, še bolj prednostno od 1-5 ut %.Compositions as claimed in claim 7, characterized in that they include from 0.5 to 30 wt. % extract based on the total weight of the preparation, preferably from 1-10 wt%, even more preferably from 1-5 wt%. 9. Pripravki po zahtevkih 7 in 8, označeni s tem, da so tekoči, poltrdni ali trdni.Preparations according to claims 7 and 8, characterized in that they are liquid, semi-solid or solid. 10. Pripravki po zahtevkih od 7 do 9, označeni s tem, da vsebujejo še druge biološko aktivne in pomožne snovi, ki delujejo sinergistično.Preparations according to Claims 7 to 9, characterized in that they contain other biologically active and auxiliary substances that act synergistically. 11. Pripravki po zahtevku 10, označeni s tem, da so biološko aktivne snovi izbrane izmed vitaminov, mineralov, drugih antioksidantov, amino- in drugih kislin, peptidov, proteinov, saharidov in maščob ter izvlečkov in izločkov iz rastlin, živali in tkivnih kultur le-teh.Preparations according to claim 10, characterized in that the biologically active substances are selected from vitamins, minerals, other antioxidants, amino and other acids, peptides, proteins, saccharides and fats, and extracts and secretions from plants, animals and tissue cultures. -teh. 12. Izvleček po zahtevkih od 1 do 6 in pripravki po zahtevkih od 7 do 11 za topikalno aplikacijo na kožo obraza, telesa in lasišča.The extract of claims 1 to 6 and the preparations of claims 7 to 11 for topical application to the skin of the face, body and scalp.
SI201500214A 2015-09-10 2015-09-10 Extract from the wood of trees of the genus fir to prevent, alleviate or treat unwanted skin changes and preparations SI25053A (en)

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