USO DE UMA COMPOSIÇÃO DESTINADA A PREPARAÇÃO DE UM MEDICAMENTO PARA A PROFILAXIA E / OU NO TRATAMENTO DA INFLAMAÇÃO INDUZIDA POR STAPHYLOCOCCUS AUREUS E USO COSMETICO NÃO TERAPEUTICO

BR112025016013A2Pending Publication Date: 2026-08-04BOBS SILVER
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Patent Information

Application Number
BR112025016013
Authority / Receiving Office
BR · BR
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-01-31
Filing Date
2024-01-31
Publication Date
2026-08-04

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Abstract

The invention relates to a composition for use as a medicament in the prophylaxis and / or treatment of inflammation, comprising at least silver in colloidal form, an extract of Sambucus nigra, an extract of Primulae flos cum calycibus and / or Hypericum perforatum extract, an extract of Pelargonium sidoides. In one embodiment, said composition is used in the prophylaxis and / or treatment of Staphylococcus aureus-induced inflammation.
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Description

1 / 28 “USE OF A COMPOSITION INTENDED FOR THE PREPARATION OF A MEDICINE FOR THE PROPHYLAXIS AND / OR TREATMENT OF INFLAMMATION INDUCED BY STAPHYLOCOCCUS AUREUS AND NON-THERAPEUTIC COSMETIC USE”

[0001] The invention relates to a composition for use as a medicament in the prophylaxis and / or treatment of inflammation, containing at least silver in colloidal form, Sambucus Nigra extract, Hypericum perforatum extract and Pelargonium sidoides extract. According to one embodiment, said composition is used in the prophylaxis and / or treatment of inflammation induced by Staphylococcus aureus.

[0002] The invention relates to the field of prophylaxis and treatment of inflammation, in particular those associated with Staphylococcus aureus. PREVIOUS ART

[0003] The therapeutic properties of silver were already known in ancient Greece: it was known, in fact, that in families where silver cutlery was used for eating, infections were less frequent. Silver has important antimicrobial properties, since the presence of one part per 100 million of elemental silver in solution is sufficient to obtain an effective antimicrobial action. It is also known that silver ions or free radicals are an active antimicrobial agent.

[0004] To make silver soluble in water, it is necessary to use a colloidal ionic form (an aqueous suspension of extremely fine silver particles), which was first obtained in 1920 thanks to a hydrolysis process in which two pure silver electrodes are used, immersed in demineralized or distilled water, to which a potential difference is applied.

[0005] Before the advent of antibiotics in 1938, colloidal silver obtained in this way was prescribed for a wide variety of diseases and infections: in fact, it had been proven effective against more than 650 different pathogens. Petition 870260066442, dated 06 / 07 / 2026, page 7 / 39 2 / 28

[0006] Colloidal silver does indeed improve the functioning of the immune system, as it acts as a catalyst, deactivating specific enzymes necessary for the metabolism of numerous bacterial, fungal, and viral species.

[0007] This success is due to the fact that it is a safe antiseptic; in fact, when used in colloidal form, silver is absorbed very slowly by the tissues so as not to cause toxic effects. It can therefore be taken orally and be part of preparations that can be taken daily by adults and children without the risk of intolerance, even if used for a prolonged period.

[0008] Colloidal silver is primarily used as an antiseptic in dermatology for the treatment of certain types of lesions. It is also known for its application as a water purification agent and as a preservative in the cosmetics industry.

[0009] However, colloidal silver is not effective against all fungal agents, viruses and bacteria.

[0010] Staphylococcus aureus is a major pathogen that is the origin of several bacterial skin infections (Liu et al., 2018; Tatiya-Aphiradee et al., 2019). This bacterium is the most frequently found staphylococcal strain in human and veterinary pathology. It shares with Escherichia coli the unfortunate distinction of being the leading cause of nosocomial infections. In France, S. aureus is also the main bacterium responsible for food poisoning.

[0011] Inflammation is considered a reaction resulting from two conditions: a pathological state or a host defense against pathogenic agents (Medzhitov, 2008; Gunalan et al., 2014; Greten & Ghvennikov, 2019; Agarwal & Shanmugam, 2020). It is well known that prolonged inflammation can lead to the development of rheumatoid polyarthritis, inflammatory bowel disease, asthma, and pancreatitis (Mueller et al., 2010), as well as predispose individuals to cancer (Agarwal & Shanmugam, 2020). An increase in levels Petition 870260066442, dated 06 / 07 / 2026, p. 8 / 39 The main mechanism of inflammation consists of 3 / 28 of cytokines, cytokine receptors, adhesion molecules, immunoregulatory factors, and various other mediators (Gunalan et al., 2014). Since chronic inflammation can have irreversible consequences, numerous studies focus on the development of anti-inflammatory products. Unfortunately, many drugs available on the market are associated with undesirable side effects. It is well known that the IL-1 family is involved in acute and chronic inflammation (Kolb et al., 2001), therefore playing an important role in the regulation of inflammatory processes (Sims et Smith, 2010). The IL-1 gene family is characterized by three constituents – IL-1α, IL-1β, and the IL-1 receptor antagonist (IL-1RA) (Dinarello, 1997). IL-1β is released after proteolytic cleavage and is very likely involved in the inflammatory process (Kolb et al.).(2001) since its overexpression and the subsequent inflammatory cascade can cause the development of an autoimmune disease (Pathak et al., 2011). Given the pathophysiological relevance of IL-β, numerous studies have focused on the development of drugs and products targeting this interleukin (Peiró et al., 2017). To date, several drugs have been approved, such as anakinra, rilonacept, and canakinumab (Peiró et al., 2017).

[0012] Furthermore, overexpression and upregulation (positive regulation) of IL8 have been reported to be associated with several cancers, including breast cancer (Singh et al., 2013). However, studies have revealed a significant increase in postmenopausal women suffering from osteoporosis and bone loss (Al-Daghri et al., 2014). Thus, reducing this marker may bring significant advances in addressing these health problems.

[0013] Thus, the need remains for an alternative to existing anti-inflammatory compounds that is effective while simultaneously limiting associated side effects. In particular, treatment and prophylaxis of inflammation, especially that associated with Staphylococcus aureus infections, remains necessary.

[0014] Unexpectedly, the applicant highlighted that the combination of silver Petition 870260066442, dated 06 / 07 / 2026, page 9 / 39 4 / 28 colloidal with various plant extracts allowed obtaining a composition effective in the prophylaxis and / or treatment of inflammations, especially inflammations caused by Staphylococcus aureus. In fact, the applicant identified that the composition according to the invention had the ability to reduce the production of inflammatory cytokines. DESCRIPTION

[0015] Thus, according to a first aspect, the invention relates to a composition for use as a medicament in the prophylaxis and / or treatment of inflammation, containing: - Silver in colloidal form; 'Sambucus Nigra Extract' - Hypericum perforatum' extract, Pelargonium sidoides extract.

[0016] According to the invention, colloidal ionic silver is understood to be an aqueous suspension of extremely fine silver particles.

[0017] Preferably, said silver in colloidal form will have a particle size between 0.1 and 30 nanometers.

[0018] Preferably, said composition for use according to the invention contains: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition.

[0019] By convention, it is generally considered that 1 mg of silver is equivalent to 1 ppm in a 1 liter solution, that is, 20 mg to 250 mg per liter of solution.

[0020] Sambucus Nigra, or Elderberry, is a shrub-like plant in the Caprifoliaceae family. Extracts from this plant can be derived from its flowers and fruits, and can be dry, aqueous and / or alcoholic extracts.

[0021] Preferably, the said composition for use according to the invention contains: - Between 0.3 and 5% by weight of the Sambucus Nigra extract composition.

[0022] Hypericum perforatum or St. John's wort, more commonly called Hypericum perforatum, is a perennial herbaceous plant of the Clusiaceae family. These extracts come from the plant or from the flowering tops which may be ground, Petition 870260066442, dated 06 / 07 / 2026, page 10 / 39 5 / 28 optionally, in water and / or in alcohol.

[0023] Preferably, the said composition for use according to the invention contains: - Between 0.5 and 11% by weight of the composition of a Hypericum perforatum extract.

[0024] Pelargonium sidoides, or Umckaloabo, is a plant native to South Africa. Extracts of this plant can be in the form of dry, aqueous and / or alcoholic extracts, and come from the roots or other parts of the plant.

[0025] Preferably, the said composition for use in accordance with the invention contains: - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0026] Treatment, according to the invention, means administering the composition according to the invention to a patient with a pathology in order to help him in his cure and relieve the symptoms, within the scope of the present invention, inflammation, preferably associated with an infection by S. aureus.

[0027] Prophylaxis, according to the invention, means administering the composition according to the invention to an individual or patient to prevent the onset or spread of a pathology, in the context of the present invention, inflammation, preferably associated with an infection by S. aureus.

[0028] Inflammation is an immune defense reaction of the body due to an aggression. Inflammation can be acute or chronic. The clinical signs of inflammation are pain (throbbing), redness, swelling (edema), a sensation of heat, and functional impairment. In histological terms, in acute forms, local vascular changes occur successively (vasodilation with circulatory slowing, increased permeability, and edema), followed by an influx of circulating leukocytes, first granulocytes, then monocytes with margination, adherence to endothelial cells, diapedesis, phagocytosis of foreign substances and cellular and tissue debris, and eventually, pus formation. The evolution of the inflammatory reaction is variable. In the case of acute inflammation, after the elimination of the causative agent, mononuclear phagocytes (monocytes, macrophages, histiocytes, etc.) Petition 870260066442, dated 06 / 07 / 2026, page 11 / 39 6 / 28 ensure the clearing of the inflammatory plane and the restoration of integrity without sequelae, or the replacement of destroyed tissues by scar tissue without functional restitution. In other cases, in the absence of elimination of the cause or due to the deficiency of certain defense mechanisms of the organism, the inflammation becomes chronic, characterized by the formation of a generally mixed inflammatory infiltrate (granulocytes, histiocytes-macrophages, lymphocytes or giant cells and epithelioid cells) with neo-angiogenesis phenomena and, above all, tissue remodeling processes (associating destruction and reconstruction phenomena), in particular with significant fibroblastic proliferation. The inflammatory reaction involves a large number of cell types (mononuclear and polynuclear phagocytes, lymphocytes, platelets, but also tissue-specific cells, endothelial cells, etc.) and tumor mediators (complement, contact system, hemostasis protein), which are also targets of therapies. Finally, most inflammatory reactions induce a systemic response involving an increase in plasma concentrations of so-called acute-phase proteins (such as C-reactive protein, serum amyloid A protein, various α-1-globulins, some complement components, fibrinogen, haptoglobin) and a decrease in the concentrations of other proteins, such as albumin, transferrin, afibronectin, and apolipoprotein A-1.The inflammatory reaction also involves interleukins, including the IL-1 family (IL-1α, IL-1β and the IL-1 receptor antagonist (IL-1RA) (Dinarello, 1997)), which plays an important role in regulating inflammatory processes (Sims and Smith, 2010). IL-8 is also an interleukin known to be involved in inflammation.

[0029] The composition for use according to the invention makes it possible to reduce the production of inflammatory cytokines, in particular IL-8, IP-10, IL-1 β and IL-6.

[0030] According to one embodiment, said composition for use according to the invention contains: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition; - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract, Petition 870260066442, dated 06 / 07 / 2026, page 12 / 39 7 / 28 - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition; - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0031] According to one embodiment, the said composition for use according to the invention also contains: - Silver in ionic form;

[0032] According to the invention, ionic silver means silver whose particles have been dissolved in water, as opposed to colloidal silver where the particles are suspended in water.

[0033] According to one embodiment, the said composition for use according to this latter embodiment contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows: i. Between 70 and 99.99% by weight of silver, silver in colloidal form; ii. Between 0.01 and 30% by total weight of silver, silver in ionic form.

[0034] According to the invention, total silver means the total amount of silver included in the composition according to the invention, regardless of its form.

[0035] According to one embodiment, the said composition for use contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows: i. Between 70 and 99.99% by weight of silver, silver in colloidal form; ii. Between 0.01 and 30% by total weight of silver, silver in ionic form; - Between 0.3 and 5% by weight of the Sambucus Nigra extract composition; - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition; - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0036] According to one embodiment, said composition for use according to the invention also contains: Petition 870260066442, dated 06 / 07 / 2026, page 13 / 39 8 / 28 - Echinacea extract, and / or Propolis and / or - Artemisia extract and / or - Extract of Allium sativum and / or - Primulae flos cum calycibus extract.

[0037] Primulae flos cum calycibus, or Primrose, is a perennial herbaceous plant of the Primulaceae family. These extracts are obtained by grinding the flowers and / or calyx of the plant, optionally mixed in water and / or alcohol. These extracts may also be dry extracts.

[0038] Preferably, said composition for use according to the invention contains: - Between 1 and 9% by weight of the composition of Primulae flos cum calycibus extract.

[0039] Echinacea, or echinaceas, designates a genus of plants in the Asteraceae family. These extracts are in the form of dry, aqueous and / or alcoholic extracts, and are produced from the root, the whole plant or the aerial parts of the plant.

[0040] Preferably, said composition for use according to the invention contains: - Between 0.01 and 8% by weight of the Echinacea extract composition.

[0041] Allium sativum, more commonly known as garlic, is a perennial plant species. Extracts of this plant can be in the form of dry, aqueous and / or alcoholic extracts, or aged garlic extract.

[0042] Preferably, said composition for use according to the invention contains: - Between 0.01 and 10% by weight of the Allium sativum extract composition.

[0043] Propolis is a product derived from plant resins and exudates that can be secreted by plants or manufactured by bees from plant resin and wax. Because propolis depends on the plant species from which it is produced, standardized propolis is often produced, defined by its color. Preferably, we will use yellow, green, or red propolis here. This propolis can be in the form of dry, purified, aqueous, and / or alcoholic extracts. Petition 870260066442, dated 06 / 07 / 2026, page 14 / 39 9 / 28

[0044] Preferably, said composition for use according to the invention contains: - Between 0.01 and 7% by weight of the propolis composition.

[0045] Wormwood, or absinthe, is a genus of plant species composed of herbaceous plants, bushes and shrubs, with pinnate leaves. Preferably, the species used according to the invention is Artemisia annua. The latter is a branched aromatic herbaceous plant. Extracts from this plant may originate from the whole plant or from its aerial parts and may be dry, aqueous and / or alcoholic extracts.

[0046] Preferably, the said composition for use according to the invention contains: - Between 0.5 and 3% by weight of the Artemisia extract composition.

[0047] Preferably, the said composition for use according to the invention contains: - Between 0.01 and 8% by weight of the composition of Echinacea extract and / or - Between 0.01 and 7% by weight of the composition of propolis, and / or - Between 0.5 and 3% by weight of the Artemisia extract composition, and / or - Between 0.01 and 10% by weight of the Allium sativum extract composition and / or - Between 1 and 9% by weight of the composition of Primulae fios cum calycibus extract.

[0048] Preferably, according to the invention, said composition for use according to the invention is composed of at least one other agent acceptable in dermatological or pharmaceutical terms.

[0049] According to the embodiment, the said composition for use according to the invention is intended to be used as a medicament in the prophylaxis and / or treatment of inflammation induced by Staphylococcus aureus.

[0050] Staphylococcus aureus or golden staphylococcus is a Gram-positive bacterium characterized by its rapidly increasing resistance to antibiotics (Tatiya-Aphiradee et al., 2019).

[0051] Preferably, said composition for use according to the invention can be administered orally, intravenously, subcutaneously, nasally, ophthalmically, aurally, rectally, Petition 870260066442, dated 06 / 07 / 2026, page 15 / 39 10 / 28 vaginal, respiratory or by application to the skin. Petition 870260066442, dated 06 / 07 / 2026, page 16 / 39 11 / 28

[0052] Ideally, oral administration can be in the form of a tablet, syrup, solution or drinkable suspension, or capsule, with tablets being preferred.

[0053] Ideally, intravenous administration can be in the form of a solution.

[0054] Ideally, subcutaneous administration can be done in solution form.

[0055] Preferably, administration is done by applying it to the skin.

[0056] Ideally, topical administration can be in the form of an ointment, cream, patch, liquid solution, or gel.

[0057] Ideally, topical application is done in the form of a cream or a liquid solution.

[0058] Preferably, the said composition for use according to the invention is administered via the respiratory or nasal route, in the form of nasal drops, nasal spray, nasal powder, aerosol, for example aerosols and / or compressed gas nasal spray, or by nebulizer.

[0059] As the composition is suitable for nasal or respiratory tract administration, it can be beneficially applied for bronchopulmonary or sinus purposes.

[0060] Preferably, the said composition for use according to the invention is administered by aerosol into the nasal passages.

[0061] The composition according to the present invention can be administered to a patient daily, once, twice, three times or even more times a day.

[0062] Preferably, the composition of the present invention is administered to a patient once a day.

[0063] The composition according to the invention may also consist of a physiologically acceptable medium, i.e., compatible with the skin or with the different modes of administration provided for.

[0064] According to one embodiment of the invention, said composition contains, by weight of the composition: Petition 870260066442, dated 06 / 07 / 2026, page 17 / 39 12 / 28 - Pharmaceutical grade purified water: qsp [quantity sufficient for] - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm; - 0.9% Sambucus Nigra extract; - 5% Hypericum perforatum extract; - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea; - 4% purified propolis extract.

[0065] According to one embodiment of the invention, said composition contains, by weight of the composition: - Pharmaceutical grade purified water: qsp [quantity sufficient for a total of 20 mg of silver, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm; - 0.9% Sambucus Nigra extract; - 5% dry extract of Phmulae filas cum calycibus; - 5% Hypericum perforatum extract; - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea; - 4% purified propolis extract.

[0066] According to one embodiment of the invention, said composition contains, by weight of the composition: - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm. - 0.9% Sambucus Nigra extract - 5% dry extract of Hypericum perforatum - 1.5% dry extract of Pelargonium sidoides. - 3% dry extract of Echinacea - 4% purified propolis extract.

[0067] According to a second aspect, the invention relates to a Petition 870260066442, dated 06 / 07 / 2026, page 18 / 39 13 / 28 cosmetic or dermatological composition, containing: - Silver in colloidal form; 'Sambucus Nigra Extract' - Hypericum perforatum' extract, Pelargonium sidoides extract.

[0068] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition.

[0069] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.3 and 5% by weight of the Sambucus Nigra extract composition.

[0070] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition.

[0071] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0072] According to one embodiment, said cosmetic or dermatological composition according to the invention contains: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition; - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract, - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition, - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0073] According to one embodiment, said cosmetic or dermatological composition according to the invention contains: - Silver in ionic form;

[0074] According to one embodiment, the said cosmetic composition or Petition 870260066442, dated 06 / 07 / 2026, page 19 / 39 14 / 28 dermatological according to this latter method of implementation contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows: i. Between 70 and 99.99% by weight of silver, silver in colloidal form; ii. Between 0.01 and 30% by total weight of silver, silver in ionic form.

[0075] According to one embodiment, the said cosmetic or dermatological composition contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows i. Between 70 and 99.99% by weight of silver, silver in colloidal form; ii. Between 0.01 and 30% by total weight of silver, silver in ionic form; - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract, - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition, - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0076] According to one embodiment, said cosmetic or dermatological composition according to the invention further contains: - Echinacea extract, and / or Propolis and / or - Artemisia extract and / or - Extract of Allium sativum and / or - Extract of Primulae filas cum calycibus.

[0077] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 1 and 9% by weight of the composition of Primulae fios cum calycibus extract.

[0078] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.01 and 8% by weight of the Echinacea extract composition. Petition 870260066442, dated 06 / 07 / 2026, page 20 / 39 15 / 28

[0079] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.01 and 10% by weight of the Allium sativum extract composition.

[0080] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.01 and 7% by weight of the propolis composition.

[0081] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.5 and 3% by weight of the Artemisia extract composition.

[0082] Preferably, said cosmetic or dermatological composition according to the invention contains: - Between 0.01 and 8% by weight of the Echinacea extract composition and / or - Between 0.01 and 7% by weight of the Propolis composition, and / or - Between 0.5 and 3% by weight of the Artemisia extract composition, and / or - Between 0.01 and 10% by weight of the Allium sativum extract composition and / or - Between 1 and 9% by weight of the composition of Primulae fios cum calycibus extract.

[0083] According to one embodiment of the invention, said cosmetic or dermatological composition contains, by weight of the composition: - Pharmaceutical grade purified water: qsp [quantity sufficient for] - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm; - 0.9% Sambucus Nigra extract - 5% Hypericum perforatum extract, - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea, - 4% purified propolis extract.

[0084] According to one embodiment of the invention, said cosmetic composition Petition 870260066442, dated 06 / 07 / 2026, page 21 / 39 16 / 28 or dermatological contains, by weight of composition: - Pharmaceutical grade purified water: qsp [quantity sufficient for] - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm; - 0.9% Sambucus Nigra extract - 5% dry extract of Primulae floss cum calycibus', - 5% dry extract of Hypericum perforatum, - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea, - 4% purified propolis extract.

[0085] According to one embodiment of the invention, said cosmetic or dermatological composition contains, by weight of the composition: - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm. - 0.9% Sambucus Nigra extract; - 5% dry extract of Hypericum perforatum; - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea, - 4% purified propolis extract.

[0086] In the context of the invention, a non-therapeutic cosmetic or dermatological composition is understood to mean an application not intended to treat a patient, but rather a healthy person. In reality, the cosmetic composition according to the invention does not function as a medicine for the treatment of diseases, but allows for the improvement of the superficial visual appearance of inflamed skin. Within the scope of the invention, the cosmetic composition allows for the reduction of visible signs of inflammation.

[0087] Preferably, said cosmetic or dermatological composition contains at least one excipient that is acceptable in cosmetic or dermatological terms.

[0088] According to the invention, "acceptable in cosmetic or dermatological terms" means an excipient useful in the preparation of a cosmetic composition. Petition 870260066442, dated 06 / 07 / 2026, page 22 / 39 17 / 28 or dermatological which is generally safe, non-toxic, not undesirable in biological or other terms for cosmetic or dermatological use, in particular for application to the skin.

[0089] According to the invention, an extract is understood to be a preparation obtained from the plants mentioned. Preferably, said extracts are obtained using a solvent.

[0090] A dry extract is understood to be an extract from which the solvent has been evaporated, leaving only the active principle or principles of the plant.

[0091] Thus, cosmetic or dermatological compositions, according to the invention, may be presented in forms commonly known for topical administration, namely, lotions, shampoos, balms, mousses, gels, dispersions, emulsions, sprays, serums, masks, liquid solutions, creams and sticks with excipients that allow, in particular, some of them, a penetration that improves the properties and accessibility of the active ingredients.

[0092] According to a third aspect, the invention is intended for non-therapeutic cosmetic or dermatological use in a healthy person of a composition containing: - Silver in colloidal form; 'Sambucus Nigra Extract' - Hypericum perforatum' extract, Pelargonium sidoides extract.

[0093] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition.

[0094] Preferably, said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 0.3 and 5% by weight of the Sambucus Nigra extract composition.

[0095] Preferably, said composition in this cosmetic use or Petition 870260066442, dated 06 / 07 / 2026, page 23 / 39 18 / 28 dermatological, according to the invention, contains: - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition.

[0096] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0097] According to one embodiment, said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition; - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract, - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition, - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0098] According to one embodiment, said composition in this cosmetic or dermatological use, according to the invention, also contains: - Silver in ionic form;

[0099] According to one embodiment, the said composition in this cosmetic or dermatological use according to this latter embodiment contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows: i. Between 70 and 99.99% by weight of silver, silver in colloidal form; ii. Between 0.01 and 30% by total weight of silver, silver in ionic form.

[0100] According to one embodiment, the said composition in this cosmetic or dermatological use contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows: i. Between 70 and 99.99% by weight of silver, silver in colloidal form; ii. Between 0.01 and 30% by total weight of silver, silver in ionic form; Petition 870260066442, dated 06 / 07 / 2026, page 24 / 39 19 / 28 - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract, - Between 0.5 and 11% by weight of the Hypericum perforatum extract composition, - Between 1 and 6% by weight of the pelargonium sidoides extract composition.

[0101] According to one embodiment, said composition in this cosmetic or dermatological use, according to the invention, also contains: - Echinacea extract, and / or Propolis and / or - Artemisia extract and / or - Extract of Allium sativum and / or - Extract of Primulae filas cum calycibus.

[0102] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 1 and 9% by weight of the composition of Primulae fios cum calycibus extract.

[0103] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 0.01 and 8% by weight of the Echinacea extract composition.

[0104] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 0.01 and 10% by weight of the Allium sativum extract composition.

[0105] Preferably, said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 0.01 and 7% by weight of the propolis composition.

[0106] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: - Between 0.5 and 3% by weight of the Artemisia extract composition.

[0107] Preferably, the said composition in this cosmetic or dermatological use, according to the invention, contains: Petition 870260066442, dated 06 / 07 / 2026, page 25 / 39 20 / 28 - Between 0.01 and 8% by weight of the Echinacea extract composition and / or - Between 0.01 and 7% by weight of the Propolis composition, and / or - Between 0.5 and 3% by weight of the Artemisia extract composition, and / or - Between 0.01 and 10% by weight of the Allium sativum extract composition and / or - Between 1 and 9% by weight of the composition of Primulae fios cum calycibus extract.

[0108] According to one embodiment of the invention, this cosmetic use makes it possible to reduce the visible signs of inflammation.

[0109] By reducing the visible signs of inflammation it is understood that, in a healthy person showing slight visible signs of inflammation, such as redness, the cosmetic composition according to the invention allows for a reduction in this visibility. In this example, the cosmetic composition according to the invention works only on the visible signs of inflammation.

[0110] According to one embodiment of the invention, this cosmetic use allows preventing and / or reducing the intensity of skin redness and / or lightening and / or evening out the complexion and / or concealing superficial redness in a healthy person.

[0111] According to one embodiment of the invention, said composition in this cosmetic or dermatological use contains, by weight of the composition: - Pharmaceutical grade purified water: qsp [quantity sufficient for] - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm; - 0.9% Sambucus Nigra extract - 5% Hypericum perforatum extract, - 1.5% dry extract of Pelargonium sidoides; Petition 870260066442, dated 06 / 07 / 2026, page 26 / 39 21 / 28 - 3% dry extract of Echinacea, - 4% purified propolis extract.

[0112] According to one embodiment of the invention, said composition in this cosmetic or dermatological use contains, by weight of the composition: - Pharmaceutical grade purified water: qsp [quantity sufficient for] - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm; - 0.9% Sambucus Nigra extract - 5% dry extract of Primulae floss cum calycibus', - 5% dry extract of Hypericum perforatum, - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea, - 4% purified propolis extract.

[0113] According to one embodiment of the invention, said composition in this cosmetic or dermatological use contains, by weight of the composition: - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm. - 0.9% Sambucus Nigra extract; - 5% dry extract of Hypericum perforatum; - 1.5% dry extract of Pelargonium sidoides; - 3% dry extract of Echinacea, - 4% purified propolis extract.

[0114] According to a fourth aspect, the invention relates to a method of treating inflammation, preferably induced by S. aureus, which involves administering to a person in need an effective amount of the composition according to the invention.

[0115] According to a fifth aspect, the invention relates to a procedure for preparing a cosmetic or dermatological composition according to the invention, Petition 870260066442, dated 06 / 07 / 2026, p. 27 / 39 22 / 28 involving at least one mixing step of the components included in the composition.

[0116] In the description and examples that follow, unless otherwise indicated, percentages are percentages by weight and the ranges of values ​​indicated in the form between... and... include the indicated lower and upper limits. The following examples are presented by way of illustration and not limitation of the field of application of the invention.

[0117] The following examples illustrate the invention without limiting its scope. FIGURES

[0118] [Fig. 1] is a histogram graph showing the IL-8 concentrations (pg / ml) after various treatments: 1 - Composition according to example 1 (in liquid solution form); 2 - Composition according to example 1 (in liquid solution form) + S. aureus; 3 - Composition according to example 1 in cream form; 4 - Composition according to example 1 in cream form + S. aureus. The data were obtained through at least three independent experiments.

[0119] [Fig. 2] is a histogram graph showing the concentrations of IP-10 (pg / ml) after various treatments: 1 - Composition according to example 1 (in liquid solution form); 2 - Composition according to example 1 (in liquid solution form) + S. aureus; 3 - Composition according to example 1 in cream form; 4 - Composition according to example 1 in cream form + S. aureus. The data were obtained through at least three independent experiments.

[0120] [Fig. 3] is a histogram graph showing the IL-1 β concentrations (pg / ml) after various treatments: 1 - Composition according to example 1 (in liquid solution form); 2 - Composition according to example 1 (in liquid solution form) + S. aureus; 3 - Composition according to example 1 in cream form; 4 - Composition according to example 1 in cream form + S. aureus. The data were obtained through at least three independent experiments. Petition 870260066442, dated 06 / 07 / 2026, pp. 28 / 39 23 / 28

[0121] [Fig. 4] is a histogram graph showing the IL-6 concentrations (pg / ml) after various treatments: 1 - Composition according to example 1 (in liquid solution form); 2 - Composition according to example 1 (in liquid solution form) + S. aureus; 3 - Composition according to example 1 in cream form; 4 - Composition according to example 1 in cream form + S. aureus. The data were obtained through at least three independent experiments. EXAMPLES:

[0122] Example 1: Example of composition:

[0123] The composition includes, per 100 mL of composition: - 20 mg of silver in total, up to 20% silver in ionic form and 80% silver in colloidal form, with an average particle size of 0.8 nm. - 0.9% Sambucus Nigra extract. - 5% dry extract of Hypericum perforatum. - 1.5% dry extract of Pelargonium sidoides. - 3% dry extract of Echinacea. - 4% purified propolis extract.

[0124] Example 2: Anti-inflammatory activity of the composition from example 1.

[0125] Materials and methods

[0126] The HT-29 human epithelial cell line was cultured in monolayers in DMEM (Eagle's medium modified by Dulbecco, Gibco, RU), supplemented with 10% fetal bovine serum, at 37 °C and 5% CO2. In approximately 90% of the monolayers, the cells underwent incubation with a 0.25% trypsin solution and 10 mM EDTA for 10 minutes at 37 °C.

[0127] To determine the anti-inflammatory effect, eukaryotic cells were cultured in 24-well plates at a concentration of 2 χ¹⁰⁵ cells / ml. The medium was changed every 2 days for a total of 14 days, favoring not only the formation of a monolayer (3-4 days) but also the maturation of cell receptors. The resulting monolayer was washed twice with phosphate-buffered saline (PBS Petition 870260066442, dated 06 / 07 / 2026, p. 29 / 39). 24 / 28 Phosphate Buffered Saline).

[0128] DMEM medium (1 ml) containing different preparations was added to each well and incubated for 20 hours at 37 °C. The preparations were as follows: - DMEM control; - DMEM with Staphylococcus aureus 1x105 CFU / ml; - DMEM with 10% of the composition according to example 1 (in the form of a liquid solution); - DMEM with 10% of the composition according to example 1 (in the form of a liquid solution) and Staphylococcus aureus 1x105 CFU / ml; - DMEM with 10% of the composition according to example 1 in cream form; - DMEM with 10% of the composition according to example 1 in cream form and Staphylococcus aureus 1x105 CFU / ml.

[0129] After incubation, the cell-free supernatant was used to determine cytokine expression. IL-8, IP-10, IL-1 β and IL-6 were evaluated by ELISA (enzyme-linked immunosorbent assay) according to the manufacturer's instructions (Diaclone, USA).

[0130] Results

[0131] These results indicate that Staphylococcus aureus increases the concentration of pro-inflammatory cytokines compared to untreated cell line samples - in DMEM medium. An increase of approximately 3 times was measured for IL-8 (Fig. 1) and IP-10 (Fig. 2). Levels approximately 2 times higher were observed for IL-1 β (Fig. 3). The smallest increase, approximately 1.5 times, was obtained for IL-6 (Fig. 4). This result demonstrates that, in these experiments, IL-8 and IP10 are the most sensitive markers of inflammation induced by Staphylococcus aureus.

[0132] The data did not reveal any overexpression of IL-8 after treatment with the two compositions according to the invention, in cream form or in liquid solution form (Fig. 1). No overexpression was measured. Petition 870260066442, dated 06 / 07 / 2026, pages 30 / 39 25 / 28 hours after applying the products to cell lines in a state of inflammation caused by S. aureus. The measured levels were similar.

[0133] The marker studied next was IP-10. The data revealed that it was possible to observe better protection, expressed by the inhibition of IP-10 overexpression, after application of the composition according to example 1, when it is not in cream form (or in liquid solution form), compared to the cream (Fig. 2).

[0134] The same was observed for the other marker studied - IL-Iβ - 60 times lower (Fig. 3). The composition according to example 1 in cream form reduced IL-Iβ induction by about one and a half times.

[0135] With regard to IL-6, the most pronounced reduction was obtained after application of the composition according to example 1 in cream form: approximately 9 times (Fig. 4). The reduction in IL-6 after application of the composition according to example 1 was calculated to be approximately 6 times lower. DISCUSSION

[0136] These results demonstrate that both preparations (the composition according to example 1 in liquid solution form and the composition according to example 1 in cream form) decrease the concentration of the four pro-inflammatory cytokines in both cases: - control samples (DMEM); and - cell lines in a state of inflammation caused by Staphylococcus aureus.

[0137] Based on the reported data, it is possible to conclude that the ability of the composition according to example 1 in liquid solution form to decrease the concentration of IL-8, IP-10 and IL-1β is greater compared to the effect of the composition according to example 1 in cream form. On the other hand, the effect of the composition according to example 1 in cream form proved to be more pronounced on IL-6 compared to the composition according to example 1 without being in cream form. Petition 870260066442, dated 06 / 07 / 2026, pages 31 / 39 26 / 28 cream form (in liquid solution form). REFERENCES - Agarwal, H., & Shanmugam, V. (2020). A review on anti-inflammatory activity of green synthe-sized zinc oxide nanoparticle: Mechanism-based approach. Bioorganic Chemistry, 94, 103423. - Al-Daghh, NM, Yakout, S., Al-Shehh, E., Al-Fawaz, H., Aljohani, N., & Al-Saleh, Y. (2014). Inflammatory and bone turnover markers in relation to PTH and vitamin D status among Saudi postmenopausal women with and without osteoporosis. International journal of clinical and experimental medicine, 7(9), 2812. - Dinarello, CA. Interleukin-1 (interleukin-1). Cytokine Growth Factor Rev 1997. 8:253-265. - Greten, FR, & Grivennikov, SI (2019). Inflammation and cancer: triggers, mechanisms, and consequences. Immunity, 51(1), 27-41. - Gunalan, G., Vijayalakshmi, K., Saraswathy, A., Hopper, W., & Tamilvannan, T. (2014). Anti-inflammatory activities of phytochemicals from Bauhinia variegata Linn, leaf: An in silico approach (Atividades anti-inflamatóhas dos fitoquímicos presentes na folha de Bauhinia variegata Linn.: Uma abordagem in silico). J. chem. pharm, 6(9), 334-48. - Kolb, M., Margetts, PJ, Anthony, DC, Pitossi, F., & Gauldie, J. (2001). Transient expression of IL-1β induces acute lung injury and chronic repair leading to pulmonary fibrosis. The Journal of Clinical Investigation, 107(12), 1529-1536. - Liu, Q., Mazhar, M., & Miller, L. S. (2018). Immune and inflammatory Petition 870260066442, dated 06 / 07 / 2026, pp. 32 / 39 27 / 28 responses to Staphylococcus aureus skin infections. Current Dermatology Reports, 7(4), 338-349. - Medzhitov, R. (2008). Origin and physiological roles of inflammation. Nature, 454(7203), 428-435. - Mueller, M., Hobiger, S., & Jungbauer, A. (2010). Anti-inflammatory activity of extracts from fruits, herbs and spices. Food Chemistry, 122(4), 987-996. - Pathak, S., Goldofsky, E., Vivas, EX, Bonagura, VR, & Vambutas, A. (2011). IL-1β is overexpressed and aberrantly downregulated in corticosteroid nonresponders with autoimmune inner ear disease (IL-1β shows overexpression and aberrant downregulation in patients with autoimmune inner ear disease who do not respond to corticosteroids). The Journal of Immunology, 186(3), 1870-1879. - Peiró, C., Lorenzo, Ó., Carraro, R., & Sánchez-Ferrer, CF (2017). IL-Iβ inhibition in cardiovascular complications associated with diabetes mellitus. Fronteiras em farmacologia, 8, 363. - Sims, JE and DE Smith. 2010. The IL-1 family: regulators of immunity. Nat. Rev. Immunol. 10: 89-102. - Singh, JK, Simões, BM, Howell, SJ, Farnie, G., & Clarke, RB (2013). Recent advances reveal IL-8 signaling as a potential key to targeting breast cancer stem cells. Breast Cancer Research, 15(4), 1-9. - Tatiya-Aphiradee, N., Chatuphonprasert, W., & Jarukamjorn, K. (2019). Anti-inflammatory effect of Garcinia mangostana Linn, pericarp extract in methicillin-resistant Staphylococcus aureus-induced superficial skin infection in mice. Petition 870260066442, dated 06 / 07 / 2026, pp. 33 / 39 28 / 28 superficial cutaneous hemorrhage induced by methicillin-resistant Staphylococcus aureus in mice). Biomedicine and Pharmacotherapy, 111, 705-713. Petition 870260066442, dated 06 / 07 / 2026, pp. 34 / 39

Claims

1 / 3 CLAIMS 1. Use of a composition containing: - Silver in colloidal form; - Sambucus Nigra extract; - Hypericum perforatum extract; - Pelargonium sidoides extract, characterized by being intended for the preparation of a medicament for the prophylaxis and / or treatment of inflammation.

2. Use according to claim 1, characterized in that said silver in colloidal form has particles with a size between 0.1 and 30 nanometers.

3. Use according to any of the preceding claims, characterized by the composition containing: - Between 20 mg and 250 mg of silver in colloidal form per liter of composition; - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract; - Between 0.5 and 11% by weight of the composition of Hypericum perforatum extract; - Between 1 and 6% by weight of the composition of pelargonium sidoides extract.

4. Use in accordance with either of claims 1 and 2, characterized in that the composition also contains: - Silver in ionic form; 5. Use according to claim 4, characterized in that the composition contains: - Between 20 mg and 250 mg of total silver per liter of composition, distributed as follows: i. Between 70 and 99.99% by weight of total silver, silver in colloidal form; ii. Between 0.01 and 30% by weight of total silver, silver in ionic form. - Between 0.3 and 5% by weight of the composition of Sambucus Nigra extract; - Between 0.5 and 11% by weight of the composition of Hypericum perforatum extract; - Between 1 and 6% by weight of the composition of pelargonium sidoides extract.

6. Use in accordance with any of the preceding claims, characterized by the composition also containing: - Echinacea extract, and / or - Propolis and / or - Artemisia extract and / or - Allium sativum extract and / or - Primulae phimosum cum calycibus extract.

7. Use according to claim 6, characterized in that the composition contains: - Between 0.01 and 8% by weight of the composition of Echinacea extract, and / or - Between 0.01 and 7% by weight of the composition of Propolis, and / or - Between 0.5 and 3% by weight of the composition of Artemisia extract, and / or - Between 0.01 and 10% by weight of the composition of Allium sativum extract and / or - Between 1 and 9% by weight of the composition of Primulae phimosum cum calycibus extract.

8. Use in accordance with any of the preceding claims, characterized by being for use as a medicine in the prophylaxis and / or treatment of inflammation induced by Staphylococcus aureus.

9. Use in accordance with any of the preceding claims, characterized by being in a form suitable for administration by application to the skin in the form of an ointment, cream, liquid solution, dressing or gel, preferably in cream or liquid solution.

10. Non-therapeutic cosmetic use to reduce the visible signs of inflammation on a patient's skin, characterized by using a composition containing: - Silver in colloidal form; Petition 870250089786, dated 02 / 10 / 2025, pp. 40 / 41 3 / 3 - Sambucus Nigra extract, - Hypericum perforatum extract; - Pelargonium sidoides extract. Petition 870250089786, dated 02 / 10 / 2025, pp. 41 / 41