WO2023187632A1

WO2023187632A1 - Composition, application of the composition, cosmetic preparation hydrogel bio-mask in the form of a compress, method of manufacturing the preparation

Info

Publication number: WO2023187632A1
Application number: PCT/IB2023/053056
Authority: WO
Inventors: Małgorzata Miastkowska; Katarzyna Bialik-Wąs
Original assignee: Politechnika Krakowska im. Tadeusza Kościuszki
Priority date: 2022-03-30
Filing date: 2023-03-28
Publication date: 2023-10-05
Also published as: PL440805A1

Abstract

The invention discloses a composition of hydrogel bio-mask, a cosmetic product a hydrogel bio-mask in the form of a compress, in the form of a hydrogel material of natural origin and natural active ingredients, which is characterized in that it is a combination of a hydrogel matrix obtained from ionically cross-linked alginates from brown algae in a hydrolate environment with bacteriostatic and antiseptic properties, preferably lavender hydrolate, which comprises active ingredient spirulina, and nanodispersion comprising lipophilic active ingredient silymarin and/or bakuchiol. The product according to the invention comprises ingredients of 100% natural origin. The preparation comprises active ingredients acting synergistically with regenerative, moisturizing, and alleviating effect: spirulina and sylimarin and lavender hydrolate obtained from species of lavender Lavandula angustifolia cultivated in Poland in Świętokrzyskie region, and oils rich in γ-linolenic acid (GLA). The object of the present invention is also a method of manufacturing the product hydrogel bio-mask.

Description

COMPOSITION, APPLICATION OF THE COMPOSITION, COSMETIC PREPARATION HYDROGEL BIO-MASK IN THE FORM OF A COMPRESS, METHOD OF MANUFACTURING THE PREPARATION

TECHNICAL FIELD

The invention refers to the composition and its use for manufacturing of a cosmetic preparation in the form of a hydrogel bio-mask in the form of a compress. The subject of the invention is also a cosmetic preparation in the form of a hydrogel bio-mask in the form of a compress and a method of producing this preparation. The preparation according to the invention has regenerative, alleviating, cooling and soothing properties, it is intended for use on the skin.

BACKGROUND ART

Hydrogels are biomaterials consisting of a three-dimensional network of polymer chains and water that fills the spaces between macromolecules.

Hydrogels can be manufatured by a variety of cross-linking strategies and are classified in different ways. Polysaccharide-based hydrogels are biocompatible, biodegradable and non-toxic. On the other hand, hydrogels based on synthetic polymers are easier to modify and have higher mechanical strength.

Hydrogels have been used as wound dressings, not only do they create a physical barrier and remove excess exudate, but also provide an environment with appropriate moisture that supports the process of wound stimulation. What's more, the hydrogel can perfectly fill irregularly shaped wounds, dealing with deep hemorrhages.

Hydrogel dressings are the complete opposite of traditional dressings - they are antibacterial, biodegradable and flexible.

The extraordinary properties of hydrogels are also utilized in cosmetic products.

Materials in the form of hydrogel matrices can be extremely valuable systems that allow for uninterrupted or controlled release of biologically active substances comprised in them after injection or direct application on the skin surface. Studies have shown that, apart from the bioactive substances themselves, an important role in increasing their biological effectiveness is also played by the physicochemical form in which the active substances are applied. The condition for the activity of active ingredients in cosmetics is the ability to penetrate the epidermis and to reach by the active substance to the appropriate receptor.

Due to the commonly visible attachment to taking care of the good condition of the skin and the fight against any imperfections or diseases, there is currently a large demand for products intended for the care and treatment of skin diseases. Therefore, there is an increasing demand for innovative products that are to contribute to meeting this challenge. Numerous studies have proven that hydrogel materials can be very helpful in this fight.

The following solutions are known from the state of the art:

From the description of the utility model application W.104254, a medical and cosmetic mask is known, which is a flexible hydrogel patch made of synthetic and natural polymers, which is packed removably in foil dividers in a single hermetic foil package. The patch has a non-geometric shape with openings for the eyes and an opening for the nose and an opening for the mouth. The patch has side incisions for the cheeks and an incision at the bottom for the chin.

The subject of the application PL238270 is a cosmetic mask used in cosmetic procedures involving the application of nutrients to the face. The cosmetic mask is made of a woven or non-woven flexible fibrous structure, laminated on the surface with materials sealing fluid migration or a layer of hydrogel or not laminated, with a shape corresponding to the outline of the face, with openings for the eyes, nose and mouth, provided with incisions directed radially towards the center of the mask, made around its circumference. The mask is characterized by the fact that there is a linear or arc perforation in the strip below the incisions or cutouts of the openings intended for the eyes, and the incision or cutout of the opening intended for the mouth. Preferably converging on both sides from the edge of the circumference of the mask to the edge of the intersection or cutout of the opening intended for the nose.

The invention EP 2 695 604 Al relates to a cosmetic composition for topical application comprising spirulina, which has as main objective to combat the action of free radicals that act on aging. The composition according to the invention provides hydration, protection and improvement of the general conditions of the skin. In the European patent application EP 2 695 604 Al a recipe of cream with spirulina was disclosed. The preparation comprises spirulina in the form of a dry extract in concentrations ranging from 0.1 to 5.0% by weight. The composition of the preparation includes an emulsifying base (cetearyl alcohol and a mixture of cetyl and stearyl alcohol ethoxylated with 20 moles of ethylene oxide), propylene glycol, glycerin, phenoxyethanol, silicone oils, octyl octanoate and ethoxylated hydrogenated castor oil.

A recipe for nanoemulsion thickened with hydrogel is known from the description of the application of the invention CN109562193 (A). The hydrogel matrix was formed using sodium alginate and hyaluronic acid. The nanoemulsion consisted of soybean oil, water and a mixture of surfactants, Tween 80 and Span 80.

Hydrogels, known from the state of the art, are most often used as dressings - bifunctional systems consisting of a hydrophilic, water-insoluble polymer matrix made of natural or synthetic polymers or their mixtures with a three-dimensional cross- linked structure and a solvent, additionally containing medicinal substances or substances supporting the skin regeneration process.

Polish patent description PL237400B discloses a method of producing a hydrogel dressing with a polymeric hydrogel matrix comprising poly(vinyl alcohol) (PVAL), with which active substances are introduced into the hydrogel matrix, characterized in that the hydrogel matrix is prepared in a process in which: to an aqueous solution of silver nanoparticles with an average particle size of 1 to 100 nm and a temperature of 80 to 90°C, in an amount to obtain a concentration of silver nanoparticles in the hydrogel dressing in the range of 2.00 to 3.00 mg/kg (ppm) for all components of the dressing hydrogel, PVAL is introduced in an amount of 5 to 15% by weight relative to all components of the hydrogel dressing and the solution is stirred for 9 to 12 hours to produce an aqueous solution of silver nanoparticles in PVAL; then the temperature of the aqueous solution of silver nanoparticles in PVA is lowered to a temperature in the range of 68 to 72°C, and then a 14.2% solution of eosin in a solvent consisting of a mixture of glycerin and water in a weight ratio of 1 :5 is added to the aqueous solution of silver nanoparticles in PVAL in an amount to obtain an eosin concentration in the hydrogel dressing in the range of 1 to 3% by weight, relative to all components of the hydrogel dressing, and the resulting composition is stirred for 1 to 2 hours; then the temperature of the resulting composition is lowered to a temperature in the range of 62 to 67°C, and then a 2.4% solution of allantoin in a solvent consisting of a mixture of propylene glycol and water is introduced to the composition in a weight ratio of 1 :3 in an amount to obtain the concentration of allantoin in the hydrogel dressing in the range of 0.1 to 0.3 wt% relative to all components of the hydrogel dressing, and the composition is stirred for 1 to 2 hours; then the temperature of the composition is lowered to a temperature in the range of 58 to 62°C, after which the preservative is introduced into the composition in an amount of 0.5 to 1.0% by weight relative to all components of the hydrogel dressing, the composition is continuously stirred for 20 to 40 minutes, after which a thickener is introduced into the composition in an amount of 2 to 10% by weight relative to all components of the hydrogel dressing, the composition is continuously stirred for 20 to 40 minutes; and the temperature of the composition is lowered to a value in the range of 48 to 52°C, then 10% sodium hydroxide (NaOH) solution is introduced into the composition in an amount necessary to obtain a pH value of the composition in the range of 5.8 to 7 and the composition is stirred for 20 to 40 minutes to form a hydrogel dressing. The subject of the application is also a hydrogel dressing obtained in this way.

The subject of the application PL432720A is a method of obtaining a hydrogel dressing material based on a natural polymer - sodium alginate and a synthetic polymer - poly(vinyl alcohol), enriched with Aloe vera extract or juice, in which a solution of sodium alginate with a concentration of 1.0 to 2.5 % by weight, in an amount from 10 to 75% by volume relative to the base composition (i.e. a mixture consisting of sodium alginate, polyvinyl alcohol and Aloe vera extract or juice), is combined at ambient temperature with continuous stirring with an aqueous solution of polyvinyl alcohol, having concentration from 5.0 to 12.5% by weight, in an amount from 10 to 70% by volume and with 2% by weight solution of Aloe vera extract or juice, in the amount of 5 to 25% by volume relative to the base composition, and then the cross-linking agent, which is polyethylene glycol) diacrylate, in the amount of 6.0 to 10% by volume, is introduced to the homogenized mixture with continuous stirring, and the whole is heated to a temperature of 68 to 72°C, then the initiator is introduced, which is a solution of 1% by weight ammonium persulfate, in an amount of 0.8 to 4.2% by volume relative to the base composition, and then the thoroughly mixed composition is subjected to a crosslinking reaction at a temperature of 65 to 80°C for 60 to 120 minutes, followed by a postcrosslinking reaction at room temperature for 24 to 48 hours.

Known from the literature are combinations of nanoformulations and hydrogel matrices. Muniz and associates [Muniz, B.V., Baratelli, D., Di Carla, S. et al. Hybrid Hydrogel Composed of Polymeric Nanocapsules Co-Loading Lidocaine and Prilocaine for Topical Intraoral Anesthesia. Sci Rep 8, 17972 (2018)] developed a hybrid hydrogel comprising polymeric nanocapsules into which lidocaine and prilocaine, drugs for local anesthetics, were incorporated. The hydrogel matrix consisted of: polyacrylic acid, propylene glycol, glycerin, paraben, triethanolamine and water. The nanocapsules were made of polycaprolactone, and their core was medium-chain triglycerides, in which the eutectic mixture was dissolved in a concentration of 5.0%. In order to prepare the nanocapsules, the O/W emulsion and evaporation of the organic solvent (acetone and chloroform) method was used. In vivo studies have confirmed long-term surface anesthesia of the oral mucosa during medical and dental procedures.

Moysan with the team [Moysan E, Gonzalez-Fernandez Y, Lautram N, Bejaud J, Bastiat G, Benoit JP. An innovative hydrogel of gemcitabine-loaded lipid nanocapsules: when the drug is a key player of the nanomedicine structure. Soft Matter. 2014 Mar 21; 10(11): 1767-77] developed a modern method of obtaining a hydrogel matrix in which lipid nanocapsules (LNC) comprising gemcitabine modified with lauric acid were suspended. The essence of the innovative solution was the fact that the active compound also acted as a gelling agent. LNC was obtained in the phase inversion process from the following raw materials: medium chain triglycerides, water phase (water and NaCl) and a mixture of polyethylene glycol and Span 80 as emulsifiers. In vitro studies confirmed the cytotoxic effect of the preparation on pancreatic and lung cancer cell lines, higher than for the commercial drug.

According to data from another publication Storozhylova and team [Storozhylova, N., Crecente-Campo, J., Cabaleiro, D. et al. An In Situ Hyaluronic Acid-Fibrin Hydrogel Containing Drug-Loaded Nanocapsules for Intra-Articular Treatment of Inflammatory Joint Diseases. Regen. Eng. Transl. Med. 6, 201-216 (2020)] received a hydrogel based on fibrin and hyaluronic acid (HA), into which nanocapsules with dexamethasone and galectin-3 inhibitor were introduced. The core of the nanocapsules was olive oil, and the shell was soy lecithin and oleylamine, grafted with hyaluronic acid. Their size was 122-135 nm. In vivo studies confirmed the anti-inflammatory effect of the obtained preparation and the potential in the treatment of arthropathies.

The hydrogel with silybin-containing nanocapsules was the subject of research by Rigon and co-authors [Rigon C, Marchiori MCL, da Silva Jardim F, Pegoraro NS, Chaves PDS, Velho MC, Beck RCR, Ourique AF, Sari MHM, Oliveira SM, Cruz L. Hydrogel containing silibinin nanocapsules presents effective anti-inflammatory action in a model of irritant contact dermatitis in mice. Eur J Pharm Sci. 2019 Sep 1;137: 104969], A copolymer of acrylic acid and alkyl methacrylate was used as the gelling agent, and in earlier studies gellan gum [Marchiori MCL, Rigon C, Camponogara C, Oliveira SM, Cruz L. Hydrogel containing silibinin-loaded pomegranate oil based nanocapsules exhibits anti-inflammatory effects on skin damage UVB radiation-induced in mice. J Photochem Photobiol B. 2017 May; 170:25- 32], The nanocapsules consisted of sorbitan monooleate (0.77%), pomegranate seed oil (3%), ethylcellulose (1%) and silybin (0.1%). In vivo studies have confirmed the efficacy of the preparation obtained in the treatment of skin inflammations.

On the other hand Eid with the team [Eid, Ahmad & Elmarzugi, Nagib & El Enshasy, Hesham. (2013). Development of Avocado oil Nanoemulsion Hydrogel using Sucrose Ester Stearate. Journal of Applied Pharmaceutical Science. 3. 145-147] developed a nanoemulsion based on avocado oil, stabilized with sucrose stearate, which was then cross-linked with carbomer, i.e. polyacrylic acid.

In recent years, there have been many literature reports on the hybrid combination of a hydrogel structure and colloidal nanocarriers as potential systems for the delivery of medicinal substances via the transdermal, oral, conjunctival and mucous membrane routes.

According to Desfrangois et al [Desfrangois C, Auzely R, Texier I. Lipid Nanoparticles and Their Hydrogel Composites for Drug Delivery: A Review. Pharmaceuticals (Basel). 2018 Nov 1;11(4): 118] in the last twenty years, gelling agents used to obtain hydrogels were mainly polyacrylic acid (26%), polysaccharides (24%) and poloxamers (9%). Among the polysaccharides, the most popular are chitosan (27%), xanthan gum (27%), cellulose (23%), dextran (13%) and alginates (10%).

It is known from the state of the art that among many natural polymers used to obtain hydrogel materials for dressings, polysaccharides, including alginates, have beneficial application properties. Alginate hydrogels belong to the group of biocompatible, biodegradable and non-toxic compounds for the human body and the environment. Alginate hydrogels can be produced in various forms, i.e. as films, membranes, fibers/nanofibers, foams.

The above information from the state of the art shows that there are no known cosmetic preparations in the form of a hydrogel bio-mask formed as a result of combining an alginate composition in a hydrolate with specific properties, additionally comprising spirulina, and a nanodispersion comprising silymarin and/or bakuchiol, by ionic cross-linking, which leads to obtaining a hydrogel matrix in the form of a compress, in which both the components that form the hydrogel matrix, as well as the active ingredients are of natural origin.

The invention also solves the problem of bioavailability of silymarin in cosmetic preparations, and thus removes the barrier in its use.

DISCLOSURE OF THE INVENTION

According to the invention a composition of hydrogel bio-mask is characterized in that it comprises: a component A and component B combined in a weight ratio of 4: 1 to 1 : 1, where the component A is: a polymer solution, which is from

0.5 to 5 parts by weight of sodium salt of alginic acid from brown algae and from 95 to 99.5 parts by weight of a hydrolate with bacteriostatic and antiseptic properties and/or anti-swelling properties and/or moisturizing, soothing and alleviating properties, and from 0.33 to 1.65 parts by weight of spirulina based on the polymer solution, from 0 to 1.2 parts by weight of a mixture of menthol and menthyl lactate relative to the polymer solution, from 0 to 2.5 parts by weight of a preservative, relative to the polymer solution, preferably benzoate sodium, and the component B an O/W nanodispersion is: from 85 to 95 parts by weight of water phase, from 4 to 12 parts by weight of the liquid lipid of oil phase, from 1 to 3 parts by weight of the stabilizer of mixture of sorbitan olivate and cetearyl olivate, in which sorbitan olivate from 30 to 50%, and cetearyl olivate from 50 to 70%, from 1 to 3 parts by weight of vegetable glycol, propanediol, from 0.005 to 0.1 parts by weight of the lipophilic active ingredient, silymarin, from 0.5 to 2 parts by weight of bakuchiol.

Preferably in the composition according to the invention the hydrolate with bacteriostatic and antiseptic properties is lavender hydrolate, or juniper hydrolate, or eucalyptus hydrolate, or neroli hydrolate, or calendula hydrolate, or tea tree hydrolate, or peppermint hydrolate, or witch hazel hydrolate. Preferably in the composition according to the invention the hydrolate with antiswelling properties is cornflower hydrolate.

Preferably in the composition according to the invention the hydrolate with moisturizing, soothing and alleviating properties is linden flower hydrolate, or rose hydrolate, or chamomile hydrolate, or calendula hydrolate, or linden hydrolate, or fig opuntia hydrolate.

Preferably in the composition according to the invention the liquid lipid of oil phase is borage seed oil Borago officinalis) and/or common evening primrose (Oenothera biennis) and/or evening primrose (Oenothera paradoxa) and/or hemp (Cannabis sativa) and/or viper's bugloss (Echium vulgare) and/or black currant seeds (Ribes nigrum).

The subject of the invention is also use of the composition described above for manufacturing of cosmetic and cosmetic-therapeutic products for topical application with moisturizing, alleviating, regenerating, soothing, anti-swelling and anti-aging effect.

In the preferable version of the invention the cosmetic and/or cosmetic- therapeutic product is chosen from the group of hydrogel compresses comprising active ingredients, preferably in the form of a hydrogel bio-mask.

The subject of the invention is a cosmetic product a hydrogel bio-mask in the form of a compress, in the form of a hydrogel material of natural origin and natural active ingredients, which is characterized in that it is a combination of a hydrogel matrix obtained from ionically cross-linked alginates from brown algae in a hydrolate environment with bacteriostatic and antiseptic properties and/or a hydrolate with antiswelling properties and/or a hydrolate with moisturizing, soothing and alleviating properties as well as active and active ingredients (component A) and O/W type nanodispersion (component B) based on oils rich in γ-linolenic acid (GLA) comprising a lipophilic active ingredient, wherein component A and component B are combined in a weight ratio of from 4: 1 to 1 : 1.

Preferably the component A, and thus the hydrogel matrix in the cosmetic product according to the invention comprises spirulina as an active ingredient and/or a mixture of menthol and menthyl lactate as an ingredient with cooling properties.

Preferably the nanodispersion comprises silymarin and/or bakuchiol as lipophilic active ingredients. Preferably the hydrogel matrix comprises lavender hydrolate, or juniper hydrolate, or eucalyptus hydrolate, or neroli hydrolate, or calendula hydrolate, or tea tree hydrolate, or peppermint hydrolate, or witch hazel hydrolate as hydrolate of bacteriostatic and antiseptic properties.

Preferably the hydrogel matrix comprises cornflower hydrolate as hydrolate with anti-swelling properties.

Preferably hydrogel matrix comprises preferably linden flower hydrolate, or rose hydrolate, or chamomile hydrolate, or calendula hydrolate, or linden hydrolate, or fig opuntia hydrolate. as a hydrolate with moisturizing, soothing and alleviating skin inflammation.

Preferably the O/W type nanodispersion (component B) comprises water phase, which constitutes from 85 to 95 parts by weight, the liquid lipid of oil phase which is oil rich in γ-linolenic acid (GLA) in the amount of from 4 to 12 parts by weight, a stabilizer which is a mixture of sorbitan olivate and cetearyl olivate in the amount from 1 to 3 parts by weight, vegetable glycol, preferably propanediol in the amount from 1 to 3 parts by weight, a lipophilic active ingredient, which is silymarin in the amount from 0.005 to 0.1 parts by weight and/or bakuchiol in the amount from 0.5 to 2 parts by weight.

Preferably the O/W type nanodispersion (component B) comprises the active ingredient - silymarin, dissolved in the vegetable glycol, preferably dissolved in propanediol

Preferably the product according to the invention as the liquid lipid of oil phase it comprises borage seed oil Borago officinalis) and/or common evening primrose (Oenothera biennis) and/or evening primrose (Oenothera paradoxa) and/or hemp (Cannabis sativa) and/or viper's bugloss (Echium vulgare) and/or black currant seeds (Ribes nigrum).

The subject of the invention is also a method of manufacturing the hydrogel biomask based on the natural polymer alginate from brown algae enriched in active substances closed in the form of nanoemulsion, in which method a natural polymer solution is prepared, a component in the form of nanoemulsion comprising an active ingredient is prepared, a cross-linking solution is prepared, and then all components are mixed, characterized in that the aqueous solution of sodium alginate is prepared by dissolving sodium salt of alginic acid from brown algae in a hydrolate with bacteriostatic and antiseptic properties, preferably in lavender hydrolate, and/or in a hydrolate with anti-swelling properties and/or in a hydrolate with moisturizing, soothing and alleviating properties, in at a temperature from 70 to 75°C, then the polymer solution is cooled to ambient temperature and is combined with continuous stirring with spirulina in an amount of 0.33 to 1.65 parts by weight relative to the polymer solution, preferably in an amount of 1 part by weight, is still stirred for 3 to 5 minutes, then to the reaction system is introduced from 0.0 to 1.2 parts by weight of a mixture of menthol and menthyl lactate relative to the polymer solution, from 0 to 2 parts by weight of a mixture of sorbitan olivate and cetearyl olivate relative on the polymer solution, from 0 to 0.5 parts by weight of sodium benzoate relative to the polymer solution and is still stirred for a period of 5 to 15 minutes (component A), then, into the reaction system an O/W type nanodispersion - (component B) is introduced, where the component B comprises a water phase, which constitutes from 85 to 95 parts by weight, a liquid lipid of the oil phase, which is an oil rich in γ-linolenic acid (GLA) in an amount of 4 to 12 parts by weight, a stabilizer which is a mixture of sorbitan olivate and cetearyl olivate in an amount of 1 to 3 parts by weight, vegetable glycol, preferably propanediol in an amount of 1 to 3 parts by weight and a lipophilic active ingredient which is silymarin in an amount of 0.005 to 0.1 part by weight and/or bakuchiol in an amount of 0.5 - 2 parts by weight, the reaction mixture is stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1-5 minutes, preferably for a period of 2 minutes while maintaining the temperature of the reaction environment at 25°C, then the resulting reaction mixture is placed at a temperature of 4-7°C for 24 hours, after this time, the obtained product is gradually heated to a temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm min for 1 minute, then the crosslinking agent is introduced into the reaction system in a volume ratio of 2:1 relative to the reaction mixture, which contains 5 parts by weight of anhydrous calcium chloride in 95 parts by weight of distilled water (component C), the composition is crosslinked at a temperature of 20 -25°C for a period of 15 to 45 minutes, preferably 30 minutes, then the obtained product is washed with water.

Preferably the component A and component B are combined in a weight ratio of 4:1 to 1 : 1.

Preferably the aqueous solution of sodium alginate - polymer solution - is prepared by dissolving from 0.5 to 5 parts by weight, preferably 3.5 parts by weight, of the sodium salt of alginic acid from brown algae in the hydrolate in an amount of 95 to 99.5 parts by weight, preferably 96.5 parts by weight.

Preferably a hydrolate with bacteriostatic and antiseptic properties was used as a dispersing agent for the preparation of the sodium alginate solution, preferably juniper hydrolate, or eucalyptus hydrolate, or neroli hydrolate, or calendula hydrolate, or tea tree hydrolate, or peppermint hydrolate, or witch hazel hydrolate.

Preferably cornflower hydrolate, was used as a dispersing agent for the preparation of the sodium alginate solution.

Preferably as a dispersing agent for the preparation of the sodium alginate solution, a hydrolate with moisturizing, soothing and alleviating skin inflammation properties was used, preferably linden flower hydrolate or rose hydrolate, or chamomile hydrolate, or calendula hydrolate, or linden hydrolate, or fig opuntia hydrolate.

Preferably in the method according to the invention as the component B - an O/W nanodispersion is used, which comprises the water phase, which constitutes from 85 to 95 parts by weight, the liquid lipid of the oil phase, which is oil rich in γ-linolenic acid (GLA) in an amount from 4 to 12 parts by weight, a stabilizer which is a mixture of sorbitan olivate and cetearyl olivate in an amount of 1 to 3 parts by weight, vegetable glycol, preferably propanediol in an amount of 1 to 3 parts by weight, and an active ingredient which is silymarin in an amount of 0.005 to 0.1 part weight and/or bakuchiol in an amount of 0.5 - 2 parts by weight.

Preferably borage seed oil Borago officinalis) and/or common evening primrose (Oenothera biennis) and/or evening primrose (Oenothera paradoxa) and/or hemp (Cannabis sativa) and/or viper's bugloss (Echium vulgare) and/or black currant seeds (Ribes nigrum) is used as the liquid lipid of oil phase.

Preferably divalent ions, preferably Ca²⁺, are used as the cross-linking agent.

Preferably Ca²⁺ ions come from a calcium salt solution, such as a calcium chloride solution.

According to the invention, a method of manufacturing a hydrogel bio-mask based on a natural polymer, alginate from brown algae, which polymer also comprises spirulina as a hydrophilic active ingredient and is enriched with hydrophobic active substances enclosed in the form of nanoemulsion particles, in which method a natural polymer solution comprising spirulina is prepared, a component in the form of a nanoemulsion comprising silymarin and/or bakuchiol is prepared, a cross-linking solution is prepared, and then the individual components are mixed, characterized in that the aqueous solution of sodium alginate is obtained by dissolving in an amount of 0.5 to 5 parts by weight , preferably 3.5 parts by weight of the sodium salt of alginic acid from brown algae, in the selected hydrolate in the amount of 95 to 99.5 parts by weight, preferably 96.5 parts by weight at a temperature of 70-75°C to obtain a polymer solution.

Then spirulina is dosed into the system in an amount of 0.33 to 1.65 parts by weight, preferably 1 part by weight relative to the polymer solution, a mixture of menthol and menthyl lactate (Corum 9230) in an amount of 0 to 1.2 parts by weight relative to the polymer solution, preservative available on the market under the name Dermosoft 1388 in an amount of 0 to 2 parts by weight relative to the polymer solution, preservative - sodium benzoate in an amount of 0 to 0.5 parts by weight relative to the polymer solution (component A), constantly stirring on a mechanical stirrer at a constant speed of 1000 -2000 rpm, preferably 1500 rpm, at a temperature of 20-25°C.

Then, the previously prepared O/W-type nanodispersion (component B) is introduced into the reaction system in a weight ratio of 4: 1 to 1 : 1.

Component B is prepared in a separate reaction unit in the following way: first, a pre-emulsion is obtained by mixing at a temperature of 60-80°C, preferably at a temperature of 67-73°C, the water phase, which consists of 85 95 parts by weight of water with the oil phase. The liquid lipid of the oil phase is an oil rich in γ-linolenic acid (GLA) in an amount of 4 to 12 parts by weight. Then, an emulsifier is added in the form of a mixture of sorbitan olivate and cetearyl olivate in the amount of 1 to 3 parts by weight, lipophilic active ingredients, i.e. bakuchiol in the amount of 0 - 2 parts by weight and silymarin in the amount of 0.005 to 0.1 parts by weight previously dissolved in vegetable glycol (propanediol), which is used in an amount of 1 to 3 parts by weight. The system is stirred on a mechanical stirrer at a speed of 300 to 700 rpm for 5 to 15 minutes, and then the pre-emulsion prepared in this way is homogenized using an ultrasonicator using the sonication amplitude from 69% to 89%, preferably the maximum sonication amplitude should not be exceed 79%, and the sonication power is from 20 - 60 W, preferably 40 W. The homogenization process is carried out for a period of 60 to 2400 s, preferably 180.

The prepared systems are combined using a mechanical stirrer with a constant rotational speed of 1500 rpm for 1-5 minutes, preferably 2 minutes at a temperature of 25°C. Then the resulting reaction mixture is placed in a refrigerator at a temperature of 4-7 °C for 24 hours. After this time, the obtained product is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then the reaction mixture is transferred to a Petri dish, a cross-linking agent - component C is added and the proper ionic crosslinking reaction is carried out. The cross-linking agent is added to the reaction system in a 2: 1 weight ratio to the amount of the starting composition. The cross-linking agent is prepared by dissolving 5 parts by weight of anhydrous calcium chloride in 95 parts by weight of water (component C). The ionic cross-linking reaction is carried out for a period of 15-45 minutes, preferably 30 minutes, at a temperature of 22-25°C. The cross-linked hydrogel compositions are then washed with distilled water to remove residual cross-linking agent, yielding a final product that can be given any shape. The final shape of the final product results from its intended use and it is a compress for use on the skin.

The product may be in the form of a mask, which is a compress to be applied to the face.

In the solution according to the invention, the skeleton of the hydrogel matrix is made up of polysaccharides in the form of alginates from brown algae, which are biocompatible, biodegradable, non-toxic and safe to use.

Unlike gels, hydrogels are not absorbed from the surface of the skin, but leave a transparent layer on it that protects against external factors and microorganisms. They also have absorptive properties, so they can absorb exudate from wounds, accelerating the healing process and regenerating damaged tissues.

The hydrolates used in the production of the preparation according to the invention enable the skin to restore its proper, slightly acidic pH, thus protecting the skin against the harmful effects of external factors and maintaining its physiological microbiome. At the same time, the use of hydrolates for the production of a cosmetic product in the form of a hydrogel bio-mask has an impact on reducing water consumption in the cosmetics industry.

The silymarin used in the product according to the invention is an active complex of flavonolignans obtained from the seed shells of milk thistle (Silybum marianum). It is an effective antioxidant and anti-inflammatory agent. It has the ability to eliminate the harmful effects of UV radiation, reduces possible allergic reactions, swelling, erythema caused by this radiation, reduces DNA damage and inhibits the induction of apoptosis (cell death). It is recommended to use silymarin in case of allergic problems and skin inflammations. There are research results showing the antiaging properties of silymarin in relation to skin cells, these properties result from the stimulating effect of silymarin on keratinocytes, which causes the synthesis of collagen and elastin. Due to the fact that this substance is characterized by very low solubility in both water and fats, thus limiting its bioavailability, which is a barrier to its use in cosmetic preparations, and thus.

The bakuchiol used in the preparation is a chemical compound called plant retinol due to its almost identical action, but without the side effects that apply to retinol and retinoid. Like retinol and retinoid, it has an exfoliating and normalizing effect, reduces wrinkles, furrows and helps to remove discoloration, normalizes sebum secretion, eliminates acne, rejuvenates and delays skin aging.

In addition, oils rich in γ-linolenic acid (GLA), which is a precursor of prostaglandin responsible for the proper condition of the skin, used in the preparation, show synergistic effects with the components of the solution according to the invention. Particularly valuable plant raw materials for obtaining oils rich in GLA are the seeds:

• borage s (Borago officinalis),’

• common evening primrose (Oenothera biennis) and evening primrose (Oenothera paradoxa),’

• hemp (Cannabis sativa),’

• viper's bugloss (Echium vulgare);

• black currant seeds (Ribes nigrum ;

The introduction of spirulina (blue-green algae) to the reaction mixture allows to obtain a product with better therapeutic properties. Spirulina has a very rich composition, because it comprises many active and nutritional substances, thanks to which it improves blood circulation, evens skin tone and is responsible for regulating the activity of sebaceous glands. In addition, it has an antioxidant effect, neutralizes harmful free radicals, thus protecting the skin against premature aging, it also has a soothing, anti-inflammatory and anti-allergic effect (inhibits the secretion of histamine).

The presence of nanodispersion in the hydrogel matrix of the preparation according to the invention increases the bioavailability of the lipophilic extract from milk thistle seeds - silymarin, and affects its stability and protects this component against external factors, while extending its action to a much greater extent than conventional preparations (creams), where it is available on the market. In addition, this form of delivery of the lipophilic active ingredient ensures deeper skin penetration, which will enhance the effectiveness of the preparation. An additional advantage of the preparation is the introduction of nanoformulation into the hydrogel matrix, to which spirulina and hydrolate have previously been introduced. This combination of active ingredients increases the effectiveness of the preparation, regenerating and soothing, due to the content of many active substances with different properties. In addition, the nanocarrier/hydrogel matrix systems are characterized by controlled release, resulting in prolonged exposure of the skin to the active ingredient in the formulation of the invention. The nanoparticles of the internal phase of the nanoemulsion comprising the lipophilic active substance (silymarin) in the first stage of action are released into the hydrogel matrix, which is cross-linked, which means that the particles of the penetrating active substance are captured and slowly released by the cross-linked structure. In this way, the exposure of the skin to the lipophilic component is prolonged. This combination also allows to extend the contact time of the preparation with the skin and increases the degree of hydration of the skin by creating a hydrophilic film on its surface and limiting transepidermal water loss. This is a very important aspect in the process of skin regeneration. The hydrolates used in the preparation as a dispersing phase in the hydrogel matrix enhance the regenerating effect of spirulina and milk thistle extract, and additionally provide bacteriostatic, antiswelling, moisturizing, soothing and alleviating inflammatory effects on the skin.

EXAMPLES

The invention has been disclosed in the examples of embodiments and in the drawings, where Fig. 1 shows an exemplary appearance of a cosmetic preparation in the form of a hydrogel face mask, Fig. 2 shows other examples of a cosmetic preparation in the form of compresses of various sizes and with different content of component B, and Fig. 3 shows the morphology and the surface topography of the hydrogel mask of the invention by SEM analysis.

Example 1

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; lavender hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECO SPA, silymarin - of company Merck, bakuchiol - of company "Zrob sobie krem", borage oil - of company Provital, demineralized water.

Component (A): The sodium salt of alginic acid obtained from brown algae in the amount of 3.5 parts by weight is dissolved in lavender hydrolate in the amount of 96.5 parts by weight, at the temperature of 70-75°C - polymer solution. Then, spirulina is dosed into the system in the amount of 1 part by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 3 minutes, at a temperature of 20-25°C.

Component (B): 0.01 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 7 parts by weight of borage oil, 1 part by weight of bakuchiol and 2 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase.

A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 87 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 70°C, then combined and dispersed using a mechanical stirrer for 10 minutes, using the stirrer's rotational speed v = 700 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 40 W, the amplitude of 79% and the sonication time of 180 s.

Component (C): 5 parts by weight of anhydrous calcium chloride is dissolved in 95 parts by weight of distilled water at a temperature of 20-25°C.

The course of the reaction for obtaining the hydrogel bio-mask No. 1 :

To component (A) component (B) is introduced in a weight ratio of 4: 1, maintaining a total weight of the reaction mixture of 30 g, while continuously stirring on a mechanical stirrer at a constant speed of 1500 rpm for 2 minutes at a temperature of 22-25°C. Then the resulting reaction mixture is placed at a temperature of 4 -7°C for 24h. After this time, it is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then, it is transferred to a Petri dish, carrying out the proper ionic cross-linking reaction using a cross-linking agent (component (C)) in a weight ratio of 2: 1 to the amount of the reaction mixture to be cross-linked. The ionic cross-linking reaction is carried out for 30 minutes at a temperature of 22 -25°C. The cross-linked hydrogel compositions are then washed with distilled water to rinse off residual cross-linking agent. As the final product, a flexible hydrogel bio-mask was obtained, which can be used as a compress on the skin.

Example 2

The course of the reaction for obtaining the hydrogel bio-mask No. 2:

To component (A) component (B) is introduced in a weight ratio of 2: 1, maintaining a total weight of the reaction mixture of 30 g, while continuously stirring on a mechanical stirrer at a constant speed of 1500 rpm for 2 minutes at a temperature of 22-25°C. Then the resulting reaction mixture is placed at a temperature of 4 -7°C for 24h. After this time, it is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then, it is transferred to a Petri dish, carrying out the proper ionic cross-linking reaction using a cross-linking agent (component (C)) in a weight ratio of 2: 1 to the amount of the reaction mixture to be cross-linked. The ionic cross-linking reaction is carried out for 30 minutes at a temperature of 22 -25°C. The cross-linked hydrogel composition is then washed with distilled water to rinse off residual cross-linking agent. As the final product, a flexible hydrogel bio-mask was obtained, which can be used as a compress on the skin.

Example 3

The course of the reaction for obtaining the hydrogel bio-mask No. 3 :

To component (A) component (B) is introduced in a weight ratio of 3: 1, maintaining a total weight of the reaction mixture of 30 g, while continuously stirring on a mechanical stirrer at a constant speed of 1500 rpm for 2 minutes at a temperature of 22-25°C. Then the resulting reaction mixture is placed at a temperature of 4 -7°C for 24h. After this time, it is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then, it is transferred to a Petri dish, carrying out the proper ionic cross-linking reaction using a cross-linking agent (component (C)) in a weight ratio of 2: 1 to the amount of the reaction mixture to be cross-linked. The ionic cross-linking reaction is carried out for 30 minutes at a temperature of 22 -25°C. The cross-linked hydrogel compositions are then washed with distilled water to rinse off residual cross-linking agent. As the final product, a flexible hydrogel bio-mask was obtained, which can be used as a compress on the skin.

Example 4

Component (A): The sodium salt of alginic acid obtained from brown algae in the amount of 3.5 parts by weight is dissolved in lavender hydrolate in the amount of 96.5 parts by weight, at the temperature of 70-75°C - polymer solution. Then, spirulina is dosed into the system in the amount of 1 part by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 3 minutes, at a temperature of 20-25°C. Component (B): 0.01 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 7 parts by weight of borage oil, 1 part by weight of bakuchiol and 2 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase.

The course of the reaction for obtaining the hydrogel bio-mask No. 4:

To component (A) component (B) is introduced in a weight ratio of 1 : 1, maintaining a total weight of the reaction mixture of 30 g, while continuously stirring on a mechanical stirrer at a constant speed of 1500 rpm for 2 minutes at a temperature of 22-25°C. Then the resulting reaction mixture is placed at a temperature of 4 -7°C for 24h. After this time, it is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then, it is transferred to a Petri dish, carrying out the proper ionic cross-linking reaction using a cross-linking agent (component (C)) in a weight ratio of 2: 1 to the amount of the reaction mixture to be cross-linked. The ionic cross-linking reaction is carried out for 30 minutes at a temperature of 22 -25°C. The cross-linked hydrogel compositions are then washed with distilled water to rinse off residual cross-linking agent. As the final product, a flexible hydrogel bio-mask was obtained, which can be used as a compress on the skin.

Example 5

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; eucalyptus hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECO SPA, silymarin - of company Merck, bakuchiol - of company "Zrob sobie krem", borage oil - of company Provital, demineralized water.

Component (A): The sodium salt of alginic acid obtained from brown algae in the amount of 2.0 parts by weight is dissolved in eucalyptus hydrolate in the amount of 98.0 parts by weight, at the temperature of70-75°C - polymer solution. Then, spirulina is dosed into the system in the amount of 1 part by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 3 minutes, at a temperature of 20-25°C.

Component (B): 0.01 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 8 parts by weight of borage oil, and 2 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase.

A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 87 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 70°C, then combined and dispersed using a mechanical stirrer for 10 minutes, using the stirrer's rotational speed v = 600 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 40 W, the amplitude of 89% and the sonication time of 120 s.

Component (C): 5 g CaCl₂ are dissolved in 95 ml of distilled water at a temperature of 20-25°C.

The course of the reaction for obtaining the hydrogel bio-mask:

To component (A) component (B) is introduced in a weight ratio of 4: 1, maintaining a total weight of the reaction mixture of 30 g, while continuously stirring on a mechanical stirrer at a constant speed of 1500 rpm for 2 minutes at a temperature of 22-25°C. Then the resulting reaction mixture is placed at a temperature of 4 -7°C for 24h. After this time, it is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then, it is transferred to a Petri dish (Φ) 18,5cm), carrying out the proper ionic cross-linking reaction using a cross-linking agent (component (C)) in a weight ratio of 2:1 to the amount of the reaction mixture to be cross-linked. The ionic cross-linking reaction is carried out for 30 minutes at a temperature of 22 -25°C. The cross-linked hydrogel compositions are then washed with distilled water to rinse off residual cross- linking agent. As the final product, a flexible hydrogel bio-mask was obtained, which can be used as a compress on the skin.

Example 6

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; neroli hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECO SPA, silymarin - of company Merck, bakuchiol - "Zrob sobie krem", hemp oil - Olvita, demineralized water, Dermosoft 1388 - Evonik Dr. Straetmans GmbH, sodium benzoate - Sigma Aldrich. Solution (A):

The sodium salt of alginic acid obtained from brown algae in the amount of 3.5 parts by weight is dissolved in neroli hydrolate in the amount of 96.5 parts by weight, at the temperature of 70-75°C - polymer solution. Then, into the system they are dosed: spirulina in the amount of 0.5 part by weight relative to the polymer solution, a mixture of menthol and menthyl lactate (Corum 9230) in the amount 0.5 parts by weight relative to the polymer solution, Dermosoft 1388 in the amount 2 parts by weight and sodium benzoate in the amount 0.5 parts by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 15 minutes, at a temperature of 20-25°C.

Component (B): 0.015 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 7 parts by weight of hemp oil, 1 part by weight of bakuchiol and 3 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase. A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 86 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 73 °C, then combined and dispersed using a mechanical stirrer for 15 minutes, using the stirrer's rotational speed v = 700 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 40 W, the amplitude of 69% and the sonication time of 180 s.

The course of the reaction for obtaining the hydrogel bio-mask No. 6: To component (A) component (B) is introduced in a weight ratio of 3: 1, maintaining a total weight of the reaction mixture of 30 g, while continuously stirring on a mechanical stirrer at a constant speed of 1500 rpm for 2 minutes at a temperature of 22-25°C. Then the resulting reaction mixture is placed at a temperature of 4 -7°C for 24h. After this time, it is gradually heated to the temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1 minute. Then, it is transferred to a Petri dish, carrying out the proper ionic cross-linking reaction using a cross-linking agent (component (C)) in a weight ratio of 2: 1 to the amount of the reaction mixture to be cross-linked. The ionic cross-linking reaction is carried out for 30 minutes at a temperature of 22 -25°C. The cross-linked hydrogel compositions are then washed with distilled water to rinse off residual cross-linking agent. As the final product, a flexible hydrogel bio-mask was obtained, which can be used as a compress on the skin.

Example 7

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; cornflower hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECO SPA, silymarin - of company Merck, bakuchiol - "Zrob sobie krem", black currant seeds oil - Olvita, demineralized water, Dermosoft 1388 - Evonik Dr. Straetmans GmbH, sodium benzoate - Sigma Aldrich.

Solution (A):

The sodium salt of alginic acid obtained from brown algae in the amount of 1.5 parts by weight is dissolved in cornflower hydrolate in the amount of 98.5 parts by weight, at the temperature of 70-75°C - (polymer solution). Then, into the system they are dosed: spirulina in the amount of 1.5 part by weight relative to the polymer solution, a mixture of menthol and menthyl lactate (Corum 9230) in the amount 0.25 parts by weight relative to the polymer solution, Dermosoft 1388 in the amount 2 parts by weight and sodium benzoate in the amount 0.5 parts by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 15 minutes, at a temperature of 20-25°C.

Component (B): 0.01 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 7 parts by weight of black currant seed oil, 1 part by weight of bakuchiol and 2 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase. A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 87 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 70°C, then combined and dispersed using a mechanical stirrer for 10 minutes, using the stirrer's rotational speed v = 700 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 40 W, the amplitude of 79% and the sonication time of 180 s.

The course of the reaction for obtaining the hydrogel bio-mask No. 7:

Example 8

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; linden flower hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECO SPA, silymarin - of company Merck, bakuchiol - "Zrob sobie krem", primrose oil - Olvita, demineralized water, Dermosoft 1388 - Evonik Dr. Straetmans GmbH

Solution (A): The sodium salt of alginic acid obtained from brown algae in the amount of 2.5 parts by weight is dissolved in linden hydrolate in the amount of 97.5 parts by weight, at the temperature of 70-75°C - (polymer solution). Then, into the system they are dosed: spirulina in the amount of 1.0 part by weight relative to the polymer solution, Dermosoft 1388 in the amount 2 parts by weight and sodium benzoate in the amount 0.5 parts by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 15 minutes, at a temperature of 20-25°C.

Component (B): 0.005 parts by weight of silymarin is dissolved in 2 parts by weight of propanediol. 8 parts by weight of primrose oil, and 2 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase. A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 87 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 70°C, then combined and dispersed using a mechanical stirrer for 10 minutes, using the stirrer's rotational speed v = 500 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 40 W, the amplitude of 89% and the sonication time of 180 s.

The course of the reaction for obtaining the hydrogel bio-mask No. 8:

Example 9

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; rose hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECOSPA, silymarin - of company Merck, bakuchiol - "Zrob sobie krem", borage oil - Olvita, demineralized water.

Solution (A):

The sodium salt of alginic acid obtained from brown algae in the amount of 3.5 parts by weight is dissolved in rose hydrolate in the amount of 96.5 parts by weight, at the temperature of 70-75°C - (polymer solution). Then, into the system they are dosed: spirulina in the amount of 0.5 parts by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 15 minutes, at a temperature of 20-25°C.

Component (B): 0.01 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 12 parts by weight of borage oil, and 3 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase. A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 82 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 70°C, then combined and dispersed using a mechanical stirrer for 15 minutes, using the stirrer's rotational speed v = 700 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 60 W, the amplitude of 89% and the sonication time of 240 s.

The course of the reaction for obtaining the hydrogel bio-mask No. 9:

Example 10

Reagents: sodium salt of alginic acid from brown algae - medium viscosity - product of Sigma Aldrich Inc.; spirulina - sea algae - a product of the company "Zrob sobie krem"; calendula hydrolate - of company ECOSPA; anhydrous calcium chloride - a product of Avantor Performance Materials Poland S.A; Olivem 1000 (a mixture of sorbitan olivate and cetearyl olivate) - of company ECO SPA, silymarin - of company Merck, bakuchiol - "Zrob sobie krem", hemp oil - Olvita, demineralized water.

Solution (A):

The sodium salt of alginic acid obtained from brown algae in the amount of 3.5 parts by weight is dissolved in calendula hydrolate in the amount of 96.5 parts by weight, at the temperature of 70-75°C - (polymer solution). Then, into the system they are dosed: spirulina in the amount of 1.0 parts by weight relative to the polymer solution, under constant stirring on a mechanical stirrer at a constant speed of 1500 rpm, for 3 minutes, at a temperature of 20-25°C.

Component (B): 0.01 parts by weight of silymarin is dissolved in 3 parts by weight of propanediol. 7 parts by weight of hemp oil, 1 part of bakuchiol, and 2 parts by weight of O/W emulsifier (a mixture of sorbitan olivate and cetearyl olivate) are weighed, which constitute the oil phase. A solution of silymarin in propanediol is added to the oil phase thus prepared. The ingredients of the aqueous phase (water) are then weighed in an amount of 87 parts by weight. In order to obtain a pre-emulsion, a certain amount of the oil phase and the water phase are heated to 70°C, then combined and dispersed using a mechanical stirrer for 10 minutes, using the stirrer's rotational speed v = 700 rpm. The obtained pre-emulsion is subjected to the homogenization process using an ultrasonicator with a probe, using the sonication power of 40 W, the amplitude of 79% and the sonication time of 180 s. Component (C): 5 parts by weight of anhydrous calcium chloride is dissolved in 95 parts by weight of distilled water at a temperature of 20-25°C.

The course of the reaction for obtaining the hydrogel bio-mask No. 9:

The obtained components and products were tested.

Chart No. 1 shows the effect of spirulina addition and nanodispersion on the viscosity of alginate systems before the actual crosslinking reaction

Chart No. 1

For cosmetic or dermatological applications, in which hydrogels are applied primarily to the surface of the skin, the produced hydrogel must have the right consistency. Too soft consistency will cause the hydrogel to flow off after application, while too hard will make it difficult to spread it on the skin surface. Chart 1 presents the viscosity results for the systems that were used to obtain the bio-mask in Example 4. The highest viscosity is shown by a solution of sodium salt of alginic acid (12,032 mPas), but the addition of spirulina (component A) and nanodispersion (component B) forming a mixture reaction (bio-mask before ion cross-linking) significantly reduced its viscosity (to 6,318 mPas, which was the aim, because it is a value close to the reference composition (6,796 mPas), i.e. a sample obtained on the basis of literature data.

Chart 2 shows the Shore C hardness results for selected products - hydrogel bio-masks from examples 1-4.

Chart No. 2

Chart 2 presents the hardness results for the reference sample, which is a hydrogel matrix containing spirulina in the amount described in examples 1-4 (component A), but without the addition of nanodispersions (component B), and biomasks with different amounts of nanodispersions. As you can see, the introduction of nanodispersion slightly reduces the hardness of the final products even to 46.7 °Sh C (Example 4), but all of them can be classified as soft materials.

Based on the obtained SEM microphotographs, it can be concluded that the structure of the product in the form of a hydrogel bio-mask is highly porous, which enables proper oxygen permeability and positively affects the release of active substances.

Claims

Patent claims A composition characterized in that it comprises: a component A and component B combined in a weight ratio of 4: 1 to 1 : 1, where the component A is: a polymer solution, which is from 0.5 to 5 parts by weight of sodium salt of alginic acid from brown algae and from 95 to 99.5 parts by weight of a hydrolate with bacteriostatic and antiseptic properties and/or anti-swelling properties and/or moisturizing, soothing and alleviating properties, and from 0.33 to 1.65 parts by weight of spirulina relative to the polymer solution, from 0 to 1.2 parts by weight of a mixture of menthol and menthyl lactate relative to the polymer solution, from 0 to 2.5 parts by weight of a preservative relative to the polymer solution, preferably benzoate sodium, and the component B an O/W nanodispersion is: from 85 to 95 parts by weight of water phase, from 4 to 12 parts by weight of the liquid lipid of oil phase, from 1 to 3 parts by weight of the stabilizer mixture of sorbitan olivate and cetearyl olivate, in which sorbitan olivate from 30 to 50%, and cetearyl olivate from 50 to 70%, from 1 to 3 parts by weight of vegetable glycol, propanediol, from 0.005 to 0.1 parts by weight of the lipophilic active ingredient, silymarin, from 0.5 to 2 parts by weight of bakuchiol. The composition according to claim 1, characterized in that the hydrolate with bacteriostatic and antiseptic properties is lavender hydrolate, or juniper hydrolate, or eucalyptus hydrolate, or neroli hydrolate, or calendula hydrolate, or tea tree hydrolate, or peppermint hydrolate, or witch hazel hydrolate. The composition according to claim 1, characterized in that the hydrolate with anti-swelling properties is cornflower hydrolate. The composition according to claim 1, characterized in that the hydrolate with moisturizing, soothing and alleviating properties is linden flower hydrolate, or rose hydrolate, or chamomile hydrolate, or calendula hydrolate, or linden hydrolate, or fig opuntia hydrolate. The composition according to claim 1, characterized in that the liquid lipid of oil phase is borage seed oil Borago officinalis) and/or common evening primrose (Oenothera biennis) and/or evening primrose (Oenothera paradoxa) and/or hemp (Cannabis sativa) and/or viper's bugloss (Echium vulgare) and/or black currant seeds (Ribes nigrum). Use of the composition according to any one of claims 1-5 for manufacturing of cosmetic and cosmetic-therapeutic products for topical application with moisturizing, alleviating, regenerating, soothing, anti-swelling and anti-aging effect. The use according to claim 6, characterized in that the cosmetic and/or cosmetic- therapeutic product is chosen from the group of hydrogel compresses comprising active ingredients, preferably in the form of a hydrogel bio-mask. A cosmetic product a hydrogel bio-mask in the form of a compress, in the form of a hydrogel material of natural origin and natural active ingredients, characterized in that it is a combination of a hydrogel matrix obtained from ionically cross-linked alginates from brown algae in a hydrolate environment with bacteriostatic and antiseptic properties and/or a hydrolate with anti-swelling properties and/or a hydrolate with moisturizing, soothing and alleviating properties as well as active and supportive ingredients (component A) and O/W type nanodispersion (component B) based on oils rich in y-linolenic acid (GLA) comprising a lipophilic active ingredient, wherein component A and component B are combined in a weight ratio of from 4: 1 to 1 : 1. The cosmetic product according to claim 8, characterized in that the component A, and thus the hydrogel matrix comprises spirulina as an active ingredient and/or a mixture of menthol and menthyl lactate as an ingredient with cooling properties. The cosmetic product according to claim 8, characterized in that the nanodispersion comprises silymarin and bakuchiol as lipophilic active ingredients. The cosmetic product according to claim 8, characterized in that the hydrogel matrix comprises preferably lavender hydrolate, or juniper hydrolate, or eucalyptus hydrolate, or neroli hydrolate, or calendula hydrolate, or tea tree hydrolate, or peppermint hydrolate, or witch hazel hydrolate, as a hydrolate of with bacteriostatic and antiseptic properties. The cosmetic product according to claim 8, characterized in that the hydrogel matrix comprises preferably cornflower hydrolate as hydrolate with antiswelling properties. The cosmetic product according to claim 8, characterized in that the hydrogel matrix comprises preferably linden flower hydrolate, or rose hydrolate, or chamomile hydrolate, or calendula hydrolate, or linden hydrolate, or fig opuntia hydrolate. as a hydrolate with moisturizing, soothing and alleviating skin inflammation properties. The cosmetic product according to claim 8, characterized in that the O/W type nanodispersion (component B) comprises water phase, which constitutes from 85 to 95 parts by weight, the liquid lipid of oil phase which is oil rich in y- linolenic acid (GLA) in the amount of from 4 to 12 parts by weight, a stabilizer which is a mixture of sorbitan olivate and cetearyl olivate in the amount from 1 to 3 parts by weight, vegetable glycol, preferably propanediol in the amount from 1 to 3 parts by weight, and a lipophilic active ingredient, which is silymarin in the amount from 0.005 to 0.1 parts by weight and/or bakuchiol in the amount from 0.5 to 2 parts by weight. The cosmetic product according to claim 14, characterized in that the O/W type nanodispersion (component B) comprises the active ingredient - silymarin, dissolved in the vegetable glycol, preferably dissolved in propanediol The cosmetic product according to claim 14, characterized in that as the liquid lipid of oil phase it comprises borage seed oil Borago officinalis) and/or common evening primrose (Oenothera biennis) and/or evening primrose (Oenothera paradoxa) and/or hemp (Cannabis sativa) and/or viper's bugloss (Echium vulgare) and/or black currant seeds (Ribes nigrum). A method of manufacturing the hydrogel bio-mask based on the natural polymer alginate from brown algae enriched in active substances closed in the form of nanoemulsion, in which method a natural polymer solution is prepared, a component in the form of nanoemulsion comprising an active ingredient is prepared, a cross-linking solution is prepared, and then all components are mixed, characterized in that the aqueous solution of sodium alginate is prepared by dissolving sodium salt of alginic acid from brown algae in a hydrolate with bacteriostatic and antiseptic properties, preferably in lavender hydrolate, and/or in a hydrolate with anti-swelling properties and/or in a hydrolate with moisturizing, soothing and alleviating properties, in at a temperature from 70 to 75°C, then the polymer solution is cooled to ambient temperature and is combined with continuous stirring with spirulina in an amount of 0.33 to 1.65 parts by weight relative to the polymer solution, preferably in an amount of 1 part by weight, is still stirred for 3 to 5 minutes, then to the reaction system is introduced from 0.0 to 1.2 parts by weight of a mixture of menthol and menthyl lactate relative to the polymer solution, from 0 to 2 parts by weight of a mixture of sorbitan olivate and cetearyl olivate relative on the polymer solution, from 0 to 0.5 parts by weight of sodium benzoate relative to the polymer solution and is still stirred for a period of 5 to 15 minutes (component A), then, into the reaction system an O/W type nanodispersion - (component B) is introduced, where the component B comprises a water phase, which constitutes from 85 to 95 parts by weight, a liquid lipid of the oil phase, which is an oil rich in y-linolenic acid (GLA) in an amount of 4 to 12 parts by weight, a stabilizer which is a mixture of sorbitan olivate and cetearyl olivate in an amount of 1 to 3 parts by weight, vegetable glycol, preferably propanediol in an amount of 1 to 3 parts by weight and a lipophilic active ingredient which is silymarin in an amount of 0.005 to 0.1 part by weight and/or bakuchiol in an amount of 0.5 - 2 parts by weight, the reaction mixture is stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm for 1-5 minutes, preferably for a period of 2 minutes while maintaining the temperature of the reaction environment at 25°C, then the resulting reaction mixture is placed at a temperature of 4-7°C for 24 hours, after this time, the obtained product is gradually heated to a temperature of 22-25°C, and then stirred with a mechanical stirrer at a constant rotational speed of 1500 rpm min for 1 minute, then into the reaction system the crosslinking agent is introduced in a volume ratio of 2: 1 relative to the reaction mixture, which comprises 5 parts by weight of anhydrous calcium chloride in 95 parts by weight of distilled water (component C), the composition is crosslinked at a temperature of 20 - 25°C for a period of 15 to 45 minutes, preferably 30 minutes, then the obtained product is washed with water. The method according to claim 17, characterized in that the component A and component B are combined in a weight ratio of 4: 1 to 1 : 1. The method according to claim 17, characterized in that the aqueous solution of sodium alginate - polymer solution - is prepared by dissolving from 0.5 to 5 parts by weight, preferably 3.5 parts by weight, of the sodium salt of alginic acid from brown algae in the hydrolate in an amount of 95 to 99.5 parts by weight, preferably 96.5 parts by weight. The method according to claim 17, characterized in that a hydrolate with bacteriostatic and antiseptic properties was used as a dispersing agent for the preparation of the sodium alginate solution, preferably juniper hydrolate, or eucalyptus hydrolate, or neroli hydrolate, or calendula hydrolate, or tea tree hydrolate, or peppermint hydrolate, or witch hazel hydrolate. The method of manufacturing a hydrogel bio-mask according to claim 17, characterized in that a hydrolate with anti-swellins properties, preferably cornflower hydrolate, was used as a dispersing agent for the preparation of the sodium alginate solution. The method according to claim 17, characterized in that as a dispersing agent for the preparation of the sodium alginate solution, a hydrolate with moisturizing, soothing and alleviating skin inflammation properties was used, preferably linden flower hydrolate or rose hydrolate, or chamomile hydrolate, or calendula hydrolate, or linden hydrolate, or fig opuntia hydrolate. The method according to claim 17, characterized in that as the component B - an O/W nanodispersion is used, which comprises the water phase, which constitutes from 85 to 95 parts by weight, the liquid lipid of the oil phase, which is oil rich in y-linolenic acid (GLA) in an amount from 4 to 12 parts by weight, a stabilizer which is a mixture of sorbitan olivate and cetearyl olivate in an amount of 1 to 3 parts by weight, vegetable glycol, preferably propanediol in an amount of 1 to 3 parts by weight, and an active ingredient which is silymarin in an amount of 0.005 to 0.1 part weight and/or bakuchiol in an amount of 0.5 - 2 parts by weight. The method according to claim 17, characterized in that borage seed oil Borago officinalis) and/or common evening primrose (Oenothera biennis) and/or evening primrose (Oenothera paradoxa) and/or hemp (Cannabis sativa) and/or viper's bugloss (Echium vulgare) and/or black currant seeds (Ribes nigrum) is used as the liquid lipid of oil phase. The method according to claim 17, characterized in that divalent ions, preferably Ca²⁺, are used as the cross-linking agent. The method according to claim 24, characterized in that Ca²⁺ ions come from a calcium salt solution, such as a calcium chloride solution.