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WO2022073484A1 - Composition pour la peau et son utilisation - Google Patents

Composition pour la peau et son utilisation Download PDF

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Publication number
WO2022073484A1
WO2022073484A1 PCT/CN2021/122710 CN2021122710W WO2022073484A1 WO 2022073484 A1 WO2022073484 A1 WO 2022073484A1 CN 2021122710 W CN2021122710 W CN 2021122710W WO 2022073484 A1 WO2022073484 A1 WO 2022073484A1
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WIPO (PCT)
Prior art keywords
glucan
acne
composition
agents
beta
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PCT/CN2021/122710
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English (en)
Chinese (zh)
Inventor
郭安娜
郭芬妮
Original Assignee
铂曼(浙江)生物科技有限公司
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Publication of WO2022073484A1 publication Critical patent/WO2022073484A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/362—Polycarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/06—Preparations for care of the skin for countering cellulitis

Definitions

  • the present invention relates to the field of skin care.
  • the present invention relates to an anti-acne and/or anti-acne composition for skin.
  • Acne also known as pimples, pimples, pimples or folliculitis
  • anti-acne drugs are mainly used in the market at present. Mainly include anti-androgens, antibiotics, retinoids and so on. Hormone drugs such as anti-androgens can easily cause endocrine disorders, affect sexual function, and also affect bone development, which has a huge impact on adolescent patients. If antibiotics are used for a long time, bacteria will develop drug resistance, the treatment effect will decrease day by day, and it will also lead to dysbiosis. Retinoic acid drugs have been verified by animal experiments and have strong teratogenicity. Topical application of retinoic acid on the skin has clear embryotoxicity and teratogenicity to mice, rats, hamsters, and rabbits in the embryo sensitive period. It can cause maternal system toxicity, and retinoic acid can also cause liver damage. The safety of clinical medication still needs to be carefully evaluated.
  • the purpose of the present invention is to provide a safe, less toxic and side effect, quick-acting composition and its use in anti-acne and/or anti-acne.
  • compositions for preparing for preparing: (a) a cosmetic for removing acne; or (b) a medicament for treating and/or preventing acne;
  • composition includes:
  • the ⁇ -glucan is ⁇ -D-glucan.
  • the ⁇ -glucan is ⁇ -1,3-glucan, preferably, ⁇ -1,3-glucan with ⁇ -1,6-branch.
  • the ⁇ -glucan includes n repeating units shown in formula I,
  • a is an integer ⁇ 0, preferably 0-50, preferably 0-10, more preferably 0-3, more preferably 1-2, more preferably 1;
  • b is an integer ⁇ 0, more preferably It is preferably 0-19, preferably 0-4, more preferably 0-1, more preferably 0.
  • Formula I is a basic repeating unit, which can be repeated in a large number to form macromolecular ⁇ -glucan, the repeating number n is an integer of ⁇ 3, preferably 30-60000, more preferably 100-10000, such as 200, 1000 , 2000, 5000, 8000 or 20000.
  • the branching degree (DB) of the ⁇ -glucan is 0.02-0.8, preferably 0.1-0.5, preferably 0.2-0.4.
  • the ⁇ -glucan includes a ⁇ -glucan having a triple helix three-dimensional structure.
  • the ⁇ -1,3-main chain of the ⁇ -glucan is the main body of the triple helix three-dimensional structure.
  • the ⁇ -1,6-branch of the ⁇ -glucan is located outside the triple helix three-dimensional structure.
  • the molecular weight of the ⁇ -glucan is ⁇ 2kD, preferably 2kD-40000kD, more preferably 20kD-20000kD.
  • the molecular weight of the ⁇ -glucan can be 5kD-35000kD; 10kD-30000kD; 50kD-25000kD; 100kD-20000kD; 200kD-18000kD; 400kD-16000kD; 2000kD-4000kD; 3000kD-5000kD; 4000kD-6000kD; 5000kD-7000kD; 6000kD-8000kD; 7000kD-9000kD;
  • the ⁇ -glucan is selected from the group consisting of: Schizophyllum ⁇ -glucan, Lentinus edodes ⁇ -glucan, Sclerotinia ⁇ -glucan, Grifola frondosa ⁇ -glucan Glycan, Pleurotus, mushroom beta-glucan, yeast beta-glucan, oat beta-glucan, or a combination thereof.
  • the ⁇ -glucan is Schizophyllum ⁇ -glucan.
  • the mushroom ⁇ -glucan has 5 ⁇ -1,3- main chains with 2 ⁇ -1,6- branches, and each branch has 1 glucose residue based ⁇ -glucan.
  • the purity of the ⁇ -glucan is ⁇ 70%, preferably ⁇ 90%, more preferably ⁇ 95%, more preferably ⁇ 99%.
  • the ⁇ -glucan has good stability.
  • the beta-glucan is in a solid form or a liquid form, such as beta-glucan solid particles or powder, or beta-glucan aqueous solution.
  • the particle size of the ⁇ -glucan particles or powder is ⁇ 20 mm, preferably 0.001-10 mm, more preferably 0.01-5 mm, more preferably 0.1-2 mm.
  • the ⁇ -glucan is completely water-soluble ⁇ -glucan.
  • the ⁇ -glucan (granule or powder) has good water solubility and/or natural solubility.
  • the solubility of the ⁇ -glucan (granule or powder) in water (100 g) at 25° C. is ⁇ 0.0001 g, preferably 0.01-50 g, more preferably 0.1-10 g.
  • the solubility of the beta-glucan (granule or powder) in water (100g) at 25°C may be 0.1-100g; 0.2-90g; 0.5-80g; 1-50g;
  • the solubility can be 0.1-0.3g; 0.2-0.4g; 0.3-0.5g; 0.4-0.6g; 0.5-0.7g; 0.6-0.8g; 0.7-0.9g; 0.8-1g; 4g; 3-5g; 4-6g; 5-7g; 6-8g; 7-9g; 8-10g.
  • the beta-glucan solution is a solution of beta-glucan in water, that is, an aqueous beta-glucan solution.
  • the ⁇ -glucan (water) solution has a high viscosity; preferably, the viscosity of the ⁇ -glucan aqueous solution (at 30°C) with a mass concentration of 0.5% is ⁇ 40 mPa ⁇ s, more preferably 100-10000 mPa ⁇ s, more preferably 500-2000 mPa ⁇ s.
  • the viscosity of the ⁇ -glucan aqueous solution (30°C) with a mass concentration of 0.5% may be 50-10000mPa ⁇ s; 100-9000mPa ⁇ s; 200-8000mPa ⁇ s; 300-7000mPa ⁇ s s; 400-6000mPa ⁇ s; 450-5000mPa ⁇ s; 500-5000mPa ⁇ s; 550-4000mPa ⁇ s; 600-3000mPa ⁇ s; 650-2000mPa ⁇ s; 700-1500mPa ⁇ s.
  • the aqueous solution of ⁇ -glucan with a mass concentration of 1% has high clarity or high light transmittance, and the light transmittance of the ⁇ -glucan aqueous solution with a mass concentration of 1% ⁇ 50%, preferably ⁇ 80%, preferably ⁇ 85%, more preferably ⁇ 95%;
  • the ⁇ -glucan solution has good stability.
  • the weight ratio of the first active ingredient to the second active ingredient is 20:0.01-5.
  • the weight ratio of the first active ingredient to the second active ingredient is 20:0.02-2.5; 20:0.05, 20:0.1, 20:0.2, 20:0.3, 20:0.4, 20:0.5, 20:0.6, 20:0.7, 20:0.8.
  • the acne includes one or more symptoms selected from the group consisting of whiteheads, blackheads, inflammatory papules, pustules, nodules, and cysts.
  • the acne is broken skin type acne and/or closed type acne.
  • the cosmetic or drug is a cosmetic or drug with reduced side effects.
  • the side effects are those caused by azelaic acid.
  • the side effects are selected from the group consisting of tingling, itching, or a combination thereof.
  • the acne treatment further includes reducing the formation and/or the degree of acne scars.
  • the acne marks include pigmentation, nodules and scars.
  • composition includes:
  • Azelaic acid 5-30 wt%
  • Beta-glucan 0.01-5 wt%
  • a cosmetically or pharmaceutically acceptable carrier or excipient is provided.
  • the azelaic acid accounts for 6-29wt% of the total weight of the composition, preferably 10-25wt%, preferably 10-20wt%, such as 12-25wt% or 15-22wt%.
  • ⁇ -glucan accounts for 0.01-3wt%, preferably 0.02-2wt%, preferably 0.025-1wt%, more preferably 0.05-0.5wt% or 0.1-0.3wt%.
  • the ⁇ -glucan is Schizophyllum ⁇ -glucan.
  • the viscosity of the aqueous solution with a mass concentration of 0.5% Schizophyllum ⁇ -glucan (30°C, rotor 3, 30rpm) is ⁇ 400mPa ⁇ s, preferably 500-2000mPa ⁇ s, more Best place, 1000-1600mPa.s.
  • the molecular weight of the Schizophyllum ⁇ -glucan is 200kD-20000kD, preferably 400kD-10000kD, more preferably 450kD-8000kD, and most preferably 1000kD-5000kD.
  • the carrier or excipient is selected from the group consisting of moisturizing agents, skin conditioning agents, thickening agents, emollients, emulsifiers, antioxidants, preservatives, anti-ultraviolet agents, film-forming agents, Oil-soluble gelling agents, organically modified clay minerals, resins, antibacterial agents, fragrances, salts, pH adjusters, conditioners, chelating agents, cooling agents, anti-inflammatory agents, skin beautifying ingredients, vitamins, amino acids, nucleic acids , an inclusion compound, a solvent (eg, water), or a combination thereof.
  • a solvent eg, water
  • the composition includes 1-25wt% of skin conditioning agent, preferably 2-20wt%, more preferably 5-15wt%.
  • the skin conditioning agent is selected from the group consisting of bisabolol, allantoin, witch hazel extract, purslane extract, astragalus extract, gentian anti-irritant factor, glycyrrhizic acid Dipotassium, octanoylglycine, Centella asiatica extract, zinc pyrrolidone carboxylate, copper pyrrolidone carboxylate, cannabidiol, venom-like tripeptide, palmitoyl tripeptide, acetyl dipeptide, acetyl hexapeptide, or a combination thereof .
  • the skin conditioning agent includes witch hazel extract, preferably, the composition includes 1-12wt% witch hazel extract, preferably 2-10wt%, more preferably Ground, 4-8 wt%.
  • the carrier or excipient includes the following group: humectant, thickener, emollient, emulsifier, antioxidant, preservative and deionized water.
  • the composition comprises:
  • Antioxidant 0-5wt%.
  • the composition includes 0.5-2 wt% thickener.
  • the composition includes 5-15 wt % of a moisturizing agent.
  • the composition includes 0-10wt% of emollient, preferably 1-10wt%.
  • the composition includes 0.2-2wt% emulsifier, preferably 0.8-1.5wt%.
  • the composition includes 0.2-2wt% antioxidant, preferably 0.5-1wt%.
  • the composition further includes a preservative.
  • the composition includes 20-80 wt% deionized water.
  • composition dosage form is selected from the following group: liquid dosage form, semi-solid or solid dosage form, preferably ointment, cream, emulsion, oil, powder, solution, gel, spray formulations, foams, suspensions, lotions, sticks.
  • the composition does not contain one or more components selected from the group consisting of antibiotics, bacteriostatic agents, retinoic acid, and hormones.
  • the aqueous solution of the Schizophyllum ⁇ -glucan has a high viscosity; preferably, the viscosity of the aqueous solution with a mass concentration of 0.5% (30° C., rotor 3, 30 rpm) is ⁇ ⁇ 400 mPa ⁇ s, and more Good ground 500-2000mPa ⁇ s.
  • the light transmittance of the aqueous solution with the mass concentration of Schizophyllum ⁇ -glucan of 0.5% is ⁇ 80%, preferably ⁇ 85%, more preferably ⁇ ⁇ 90%;
  • the thickener is selected from the group consisting of fatty alcohols, fatty acids, alkanolamides, ethers, esters, amine oxides, celluloses, polyacrylic acids, natural gums type, polymeric thickeners, or a combination thereof.
  • the moisturizing agent is selected from the group consisting of polyols, natural moisturizing factors, amino acids, macromolecular biochemical molecules, or a combination thereof.
  • the emollient is selected from the group consisting of isononyl isononanoate, pentaerythritol tetra(ethylhexanoate), cetearyl alcohol ethylhexanoate, caprylic acid triglyceride, capric acid Acid triglycerides, triglycerides (ethylhexanoate), cocoa butter substitute, grapeseed oil, shea butter, isooctyl palmitate, jojoba oil, PEG-6 caprylic/capric glycerides, Macadamia Oil, Squalane, Camellia Oil, Grape Seed Oil, Emu Oil, Hydrogenated Polydecene, Isohexadecane, PEG/PPG-17/6 Copolymer, Cetylstearyl Alcohol, C12-15 Silicone oils such as alkanol benzoate, PEG-12/dimethicone, or a combination thereof.
  • the emulsifier is selected from the group consisting of polysorbate-80, PEG-60 hydrogenated castor oil, PEG-40 hydrogenated castor oil, hydrogenated lecithin, beeswax, polyol ester, fatty alcohol polyol Macromolecular emulsifiers such as oxyethylene ether, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer, or combinations thereof.
  • the antioxidant is selected from the group consisting of vitamin A, vitamin E, cysteine, ascorbic acid, superoxide dismutase, glutathione peroxidase, coenzyme Q10, tocopheryl acetate ester, ergothioneine, or a combination thereof.
  • the preservative is selected from the group consisting of phenols, acids, parabens, isothiazolinones, urea formaldehyde releasers, bacteriostatic agents, and not in the list of preservatives But no added preservatives (such as hexylene glycol, pentylene glycol, ethylhexylglycerol, p-hydroxyacetophenone, capryloyl hydroxamic acid, etc.) that can play a preservative effect, or a combination thereof.
  • preservatives such as hexylene glycol, pentylene glycol, ethylhexylglycerol, p-hydroxyacetophenone, capryloyl hydroxamic acid, etc.
  • the composition comprises, % based on the total weight of the composition:
  • a second aspect of the present invention a method of treating and/or preventing acne, comprising the steps of: administering to a subject in need thereof an effective amount of the composition,
  • composition includes:
  • the ⁇ -glucan is Schizophyllum ⁇ -glucan.
  • the application is to apply the composition of the present invention to the affected area of acne.
  • the subject is a mammal, such as a human, a rat, or a mouse.
  • the subject is a pregnant woman or a person with sensitive skin.
  • Figure 1 Comparison of acne before and after male volunteer A tried formula III cream.
  • Figure 2 Comparison of acne before and after male volunteer A tried formula IV cream.
  • Figure 3 Comparison of acne before and after male volunteer B tried formula V cream.
  • Figure 4 Comparison of acne before and after the male volunteer C tried formula VI cream.
  • Figure 5 Comparison of acne conditions before and after male volunteer D tried formula VI cream.
  • Figure 6 Comparison of acne conditions before and after male volunteer D tried formula VIII cream.
  • Figure 7 Comparison of acne conditions before and after female volunteer E tried formula VII cream.
  • azelaic acid and ⁇ -glucan especially Schizophyllum ⁇ -glucan
  • ⁇ -glucan have a synergistic effect in the treatment of acne, and only a very small amount of ⁇ -glucan can be added.
  • the present invention has been completed on this basis.
  • the term “about” means that the value may vary by no more than 1% from the recited value.
  • the expression “about 100” includes all values between 99 and 101 and (eg, 99.1, 99.2, 99.3, 99.4, etc.).
  • the terms "containing” or “including (including)” can be open, semi-closed, and closed. In other words, the term also includes “consisting essentially of,” or “consisting of.”
  • room temperature refers to a temperature of 4-40°C, preferably, 25 ⁇ 5°C.
  • the invention provides the use of azelaic acid and beta-glucan as active ingredients, which are used in combination in treating acne.
  • the ⁇ -glucan is Schizophyllum ⁇ -glucan.
  • azelaic acid commonly known as azelaic acid, refers to a structural compounds.
  • Schizophyllum beta-glucan refers to beta-glucan produced by Schizophyllum commune Fr. It can usually be extracted from Schizophyllum fruiting bodies, fermentation broth and/or mycelium.
  • the molecular weight of the Schizophyllum ⁇ -glucan is 200kD-20000kD, preferably 400kD-10000kD, more preferably 450kD-8000kD, and most preferably 1000kD-5000kD.
  • the aqueous solution of the Schizophyllum ⁇ -glucan has a high viscosity; preferably, the viscosity of the aqueous solution with a mass concentration of 0.5% (30° C., rotor 3, 30 rpm) is greater than or equal to 400 mPa ⁇ s, preferably 500-2000 mPa ⁇ s, more preferably, 1000-1600 mPa ⁇ s. Viscosity can reflect the molecular weight of beta-glucan.
  • the first active ingredient and the second active ingredient may be independent of each other, or may be combined together to form an active ingredient composition.
  • the weight ratio of the first active ingredient to the second active ingredient is 20:0.01-5.
  • acne As used herein, the terms “acne,” “pox,” and “pimples” are used interchangeably to refer to acne. Usually, it is called “acne” or “pimple” in the cosmetic field, and “acne” in medicine.
  • acne types mainly include: papular acne, pustular acne, nodular acne, cystic acne.
  • Papular acne inflammatory or non-inflammatory small granular acne, diameter ⁇ 5mm, can be scattered or dense and appear in pieces.
  • Pustular acne mainly small pustules, accompanied by inflammatory papules, the diameter is less than or equal to 5mm, and the pustules contain a large amount of pus, which is relatively viscous.
  • Nodular acne On the basis of pustular acne, a large number of keratin, sebum and pus cells accumulate in the sebum of the hair follicle, which destroys the sebum structure of the hair follicle and forms a red or light color above or under the skin Nodules, the invasion site is deep, the touch is hard, and some are painful when pressed.
  • Cystic acne mainly cystic masses of different sizes, without cusps, with severe inflammation, containing a large amount of tissue fluid, strong pain when pressing, often bursting and overflowing with pus. Often accompanied by papules, nodules, pustules, abscesses and so on.
  • composition of the present invention includes:
  • the first active ingredient and the second active ingredient are prepared together with a cosmetically or pharmaceutically acceptable carrier or excipient to form a composition suitable for administration.
  • the first active ingredient and the second active ingredient of the present invention have a synergistic effect in treating acne, and surprisingly, ⁇ -glucan (especially Schizophyllum ⁇ -glucan) can reduce the azelaic acid-induced Side effects (such as stinging, itching, etc.), the combination or composition of the above-mentioned active ingredients is particularly suitable for preparing a cosmetic for acne treatment; or a medicament for treating and/or preventing acne.
  • cosmetic acceptable or “pharmaceutically acceptable” ingredients refer to ingredients that are suitable for use in humans and/or animals without undue adverse side effects (eg, toxicity, irritation, and allergy), i.e., reasonable the benefit/risk ratio of the substance.
  • the term "effective dose” refers to any amount of a cosmetic or drug, as described below, which, when used alone or in combination with another therapeutic agent, promotes regression of disease, which manifests itself as disease The severity of symptoms decreased and the frequency and duration of disease-free periods increased.
  • a “therapeutically effective dose” of a drug of the present invention also includes a “prophylactically effective dose", which is any amount of the drug as described below, when the amount of the drug is administered alone or in combination with another therapeutic agent In a subject at risk of developing the disease or suffering from relapse of the disease, the occurrence or relapse of the disease can be inhibited.
  • compositions or pharmaceutical composition of the present invention prevents, alleviates, inhibits and/or reverses acne as compared to levels observed in the absence of the composition or pharmaceutical composition of the present invention, for example At least about 10%, at least about 30%, at least about 50%, or at least about 80%.
  • the carrier or excipient is selected from the group consisting of humectants, skin conditioners, thickeners, emollients, emulsifiers, antioxidants, preservatives, anti-ultraviolet agents, film formers, oil-soluble gels Chemical agents, organically modified clay minerals, resins, fragrances, salts, pH adjusters, conditioners, antibacterial agents, chelating agents, cooling agents, anti-inflammatory agents, skin beautifying ingredients, vitamins, amino acids, nucleic acids, inclusion compounds , a solvent (eg, water), or a combination thereof.
  • humectants e.g, skin conditioners, thickeners, emollients, emulsifiers, antioxidants, preservatives, anti-ultraviolet agents, film formers, oil-soluble gels Chemical agents, organically modified clay minerals, resins, fragrances, salts, pH adjusters, conditioners, antibacterial agents, chelating agents, cooling agents, anti-inflammatory agents, skin beautifying ingredients
  • the thickeners include fatty alcohols or fatty acids such as lauryl alcohol, fatty acids; alkanolamides such as cocamide; ethers such as cetyl polyoxyethylene (3) ether; esters such as PEG-150 distearate ; amine oxides such as cocamidopropyl amine oxide; cellulose such as carboxymethyl cellulose; polyacrylic acid such as carbomer; natural gum and its modifications such as sodium alginate, xanthan gum; and new One or more than two kinds of polymer thickeners such as polyvinylpyrrolidone, acryloyldimethyl ammonium tauronate/vp copolymer, etc.
  • fatty alcohols or fatty acids such as lauryl alcohol, fatty acids
  • alkanolamides such as cocamide
  • ethers such as cetyl polyoxyethylene (3) ether
  • esters such as PEG-150 distearate
  • amine oxides such as cocamidopropyl amine oxide
  • the moisturizing agent refers to polyols, natural moisturizing factors, amino acids, macromolecular biochemical molecule moisturizing agents, and combinations thereof, specifically glycerol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, caprylyl glycol, sorbitan Alcohol, Xylitol, Polyethylene Glycol, PCA-Na, Sodium Lactate, Urea, Hydrolyzed Protein, Soy Protein, Collagen, Chondroitin Sulfate, Ceramide, Betaine, Trehalose, Chitosamine, Polyglyceryl Ether- 26.
  • emollient refers to various synthetic esters and natural oils such as isononyl isononanoate, pentaerythritol tetra(ethylhexanoate), cetearyl alcohol ethylhexanoate, caprylic/capric triglyceride , Triglyceride (ethylhexanoate), Cocoa Butter Replacement, Grapeseed Oil, Shea Butter, Isooctyl Palmitate, Jojoba Oil, PEG-6 Caprylic/Capric Glycerides, Macadamia Oil, Squalane, Camellia Seed Oil, Grape Seed Oil, Emu Oil, Hydrogenated Polydecene, Isohexadecane, PEG/PPG-17/6 Copolymer, Cettostearyl Alcohol, C12-15 Alkanol Benzyl One or more of two or more of acid esters, silicone oils such as PEG-12/polydimethylsiloxane, etc., in
  • the skin conditioning agent refers to raw materials with functions such as anti-inflammatory, anti-allergic, soothing, anti-oxidation and oil control, such as bisabolol, allantoin, witch hazel extract, purslane extract, astragalus extract, gentian Anti-irritant, Dipotassium Glycyrrhizinate, Caprylyl Glycine, Centella Asiatica Extract, Zinc Pyrrolidone Carboxylate, Copper Pyrrolidone Carboxylate, Cannabidiol, Venom-like Tripeptide, Palmitoyl Tripeptide, Acetyl Dipeptide, Acetyl One of the hexapeptides or the like or two or more in any ratio.
  • the extract or extract can be a commercially available product commonly used in the art, for example, the witch hazel extract is the natural extract of witch hazel, which can be purchased commercially.
  • the emulsifier is polysorbate-80, PEG-60 hydrogenated castor oil, PEG-40 hydrogenated castor oil, hydrogenated lecithin, beeswax, polyol ester, fatty alcohol polyoxyethylene ether, hydroxyethyl acrylate/acryloyl
  • polymer emulsifiers such as sodium dimethyl taurate copolymer, etc., in an arbitrary ratio.
  • the antioxidant is one of vitamin A, vitamin E, cysteine, ascorbic acid, superoxide dismutase, glutathione peroxidase, coenzyme Q10, tocopheryl acetate, ergothioneine, etc. Any ratio of two or more.
  • the preservatives are methylparaben, ethylparaben, propylparaben, butylparaben and other paraben esters; methylisothiazolinone, methylchloroisothiazolinone, etc.
  • Isothiazolinones DMDM hydantoin, imidazolidinyl urea, bis(hydroxymethyl) imidazolidinyl urea and other formaldehyde releasers; pentanediol, hexanediol, caprylyl glycol, phenethyl alcohol, phenylpropanol , ethylhexylglycerin, glycerol caprate, capric acid, glycerol caprylate, sorbitan caprylate, glyceryl undecylenate, p-hydroxyacetophenone, levulinic acid, anisic acid, capryloylhydroxime
  • compositions of the present invention is suitable for external use on the skin. They may be in liquid, semi-solid or solid dosage forms, more preferably ointments, creams, emulsions, oils, powders, solutions, gels, sprays, foams, suspensions, lotions or patches sticks. They can also be in the form of suspensions of microspheres or nanospheres, or in the form of lipid or polymeric carriers, or in the form of polymeric patches, and in the form of controlled release hydrogels. These compositions for topical application may be in the form of anhydrous, aqueous or emulsion formulations.
  • the combination of ⁇ -glucan and azelaic acid not only shows a synergistic effect in treating acne, but also can significantly reduce side effects such as stinging and/or itching caused by azelaic acid, which is very suitable for For the preparation of medicines for treating acne or cosmetic products for treating acne.
  • composition of the present invention is convenient to use, safe, non-teratogenic, non-toxic and non-toxic.
  • composition of the present invention may not contain hormone components, and will not affect the endocrine and the growth and development of adolescents.
  • composition of the present invention can be free of antibiotics and will not cause drug resistance problems.
  • composition of the present invention does not have teratogenic components, and also does not cause serious consequences such as liver damage, and even pregnant women can use it with confidence.
  • composition of the present invention has high efficacy and quick effect on acne of various degrees.
  • Schizophyllum ⁇ -glucan (Schizophyllum communeFr.), purchased from Zhejiang Lien Biotechnology Co., Ltd. ( ⁇ -glucan molecular weight ⁇ 2000kD, 0.5wt% aqueous solution viscosity>1000mPa s (30°C, rotor 3, 30rpm), generally 1000-1600mPa ⁇ s (30°C, rotor 3, 30rpm), and the rest of the substances are common components in the market.
  • the preparation method is as follows:
  • thickener such as ammonium acryloyl dimethyl taurate/vp copolymer or other thickeners
  • oil phase such as caprylic acid/capric triglyceride for dispersion
  • Disperse add to the water phase when homogenizing), also placed in the above water bath, so that the two phases reach the same temperature.
  • emulsifiers such as PEG-60 hydrogenated castor oil (it can also be added to any one of the two phases before mixing), homogenize (homogenization refers to high-speed stirring, such as using mechanical equipment to make The mixture is highly homogenized to achieve emulsification), so that the ingredients are mixed well and a homogeneous cream is obtained.
  • 60 volunteers suffering from broken skin acne were divided into 6 groups, 10 people in each group, respectively used the anti-acne creams of formulas I, II, III, IV, IX, X in the above-mentioned embodiment 1, in the morning and evening on the acne affected area. Each small area is smeared once and used for 3 days for evaluation. While evaluating the therapeutic effect, the adverse reactions were evaluated.
  • the formula I of 20% azelaic acid (Schizophyllum ⁇ -glucan) is treated for 3 days for broken skin type acne, and its effective rate is as high as 80%, and the cure rate is 20%.
  • the formula II of 0.1% Schizophyllum ⁇ -glucan (without azelaic acid) has an effective rate of 90% and a cure rate of 20%.
  • the two are used in combination, such as formula III (10% azelaic acid combined with 0.05% Schizophyllum ⁇ -glucan)
  • the effective rate is 100%, and the cure rate is 40%, which is significantly higher than the single use of azelaic acid.
  • Acid or Schizophyllum ⁇ -glucan (100% increase in cure rate) it can be seen that azelaic acid and Schizophyllum ⁇ -glucan have a synergistic effect in the treatment of acne.
  • anti-acne cream formulas III and IV of the present invention which are used in combination with azelaic acid and Schizophyllum ⁇ -glucan, can reach 100% effectiveness in treating broken skin type acne, and the average cure rate is 45%. With IV, the cure rate reached 50% within 3 days, and the average time to effect was only 0.90 days.
  • yeast ⁇ -glucan and oat ⁇ -glucan did not significantly promote the efficacy of the formula.
  • Broken skin acne refers to obvious damage to the skin at the acne site.
  • the composition can avoid the skin barrier function and enter directly by topical application.
  • the adverse reactions of azelaic acid at the broken skin are mainly stinging and itching, but due to The tingling sensation can mask minor sensations such as itching, so stinging is mainly recorded here.
  • formula II which has no adverse reactions, the other formulas containing azelaic acid have adverse reactions of varying degrees.
  • the stinging reaction mainly occurs 1-5 minutes after smearing.
  • formulas I, IX, and X last for a long time, about 9.8 minutes on average, while formulas III and IV last for a short time, with an average of 4.8 minutes, and then disappear on their own.
  • the volunteers told that the adverse reactions were acceptable.
  • Schizophyllum ⁇ -glucan has a significant improvement effect on adverse reactions, and the stinging duration of formula III and IV is far less than that of formulas I and IX without Schizophyllum ⁇ -glucan. and X.
  • the improvement effect of Schizophyllum ⁇ -glucan on adverse reactions was dose-dependent, and the adverse reactions gradually decreased with the increase of the addition amount.
  • 60 volunteers suffering from closed acne were divided into 6 groups with 10 people in each group, respectively using the anti-acne creams of formulas I, II, III, IV, IX, X in the above-mentioned embodiment 1, respectively, in the morning and evening on the acne affected area. Apply once on a small area, and use it for 1 week for evaluation. While evaluating the therapeutic effect, the adverse reactions were evaluated.
  • the formula I containing 20% azelaic acid (Schizophyllum azela beta-glucan) was treated for 1 week for closed acne, and its effective rate was as high as 90%, and the cure rate was 30%.
  • the formula II containing 0.1% Schizophyllum ⁇ -glucan (without azelaic acid) had an effective rate of 80% and a cure rate of 10%.
  • formula III (10% azelaic acid combined with 0.05% Schizophyllum ⁇ -glucan)
  • the effective rate is 100%, and the cure rate is 50%, which is significantly higher than that of azelaic acid alone.
  • Acid or Schizophyllum ⁇ -glucan it can be seen that azelaic acid and Schizophyllum ⁇ -glucan have a synergistic effect in the treatment of acne.
  • the anti-acne cream formulas III and IV used in combination with azelaic acid and Schizophyllum ⁇ -glucan of the present invention have an average effectiveness of treating closed acne of 100% and an average cure rate of 55%, of which formula IV The cure rate is 60% after 1 week of use.
  • the stinging reaction mainly occurred 1-5 minutes after application, and the incidence rate of formula I, IX, X was 53.3%, and the duration was longer, with an average of 9.93 minutes, while the incidence rate of formula III and IV was 35%, and the duration was longer. Short, an average of 4.2 minutes.
  • the itching reaction was similar to stinging, and the azelaic acid formulation without Schizophyllum ⁇ -glucan had a high incidence of pruritus reaction (73.3%) and lasted for more than 20 minutes, while the Combined use (formula III, IV), the incidence of itching reaction decreased to 40%, and the duration decreased to less than 8 minutes, with an average of 5.8 minutes. Subsequently, the above-mentioned adverse reactions such as tingling and itching disappeared on their own without subsequent adverse effects, and the volunteers reported that the adverse reactions were acceptable.
  • Schizophyllum ⁇ -glucan can significantly improve adverse reactions, and the incidence and duration of stinging and itching of formula III and IV are much less than those without Schizophyllum ⁇ -glucan.
  • Formulations I, IX and X are much less than those without Schizophyllum ⁇ -glucan.
  • the improvement effect of Schizophyllum ⁇ -glucan on adverse reactions was dose-dependent, and the adverse reactions gradually decreased with the increase of the addition amount.
  • Figure 1 shows a male volunteer A, 29 years old, with long-term acne on the right face and uneven skin.
  • the formula III cream was tried, and the results showed that after 1 day of trial, the skin on the slightly raised acne site gradually flattened or scabbed, and after 2 days of trial, there was basically no raised inflammatory acne on the skin.
  • Figure 2 shows a male volunteer A, 29 years old, with long-term acne on the right face and uneven skin. Try formula IV cream when acne recurs. After 1 day of trial use, the inflammatory acne that was originally protruding and red was completely healed and scabbed. After 3 days, the scabs fell off, and there were no obvious new acne marks.
  • Figure 3 shows a case of male volunteer B, 28 years old, with long-term recurrent acne on the mandibular margin, and a large number of outbreaks at the same time, lighter in summer and heavier in winter.
  • I tried Formula V Cream and after 1 day of trial, the acne area scabs, and after 2 days, the scabs fall off. After 2 weeks of trial, there was no recurrence and no severe acne breakouts in winter.
  • Figure 4 shows a case of male volunteer C, 34 years old, with occasional acne, and the forehead acne has broken skin. Tried formula VI cream for 1 day, and the acne area was calmed and scabbed. On the 2nd day of trial, the scab basically fell off, leaving only slight acne marks. The volunteer was accompanied by tingling and itching when using the cream, the stinging lasted about 2 minutes, and the itching lasted about 5 minutes.
  • Figure 5 shows a case of male volunteer D, 14 years old, with acne outbreaks on the back for about 1 year, and the skin lesions are large.
  • Trial formula VI cream was effective for 1 day, and by the 4th day, most of the acnes subsided, inflammation and redness subsided.
  • Figure 6 shows a male volunteer D, 14 years old, with acne outbreaks on the back for about 1 year. After trying formula VI cream for improvement, it relapsed after discontinuation for a period of time, and many acne marks were produced. Tried formula VIII cream for 10 days, and the original large-sized acne got better, especially the acne marks were obviously faded.
  • Figure 7 shows a case of female volunteer E, 40 years old, who used skin care products containing Schizophyllum ⁇ -glucan for a long time, and had occasional acne.
  • an inflamed pustule-type small acne occurred under the nose.
  • the pustule fell off by itself, and after 2 days of trial, there was basically no acne marks.
  • Formula I and Formula IV in Example 1 are selected for comparison. The difference between the two is that Formula IV has added 0.1% Schizophyllum ⁇ -glucan, Formula I has not added Schizophyllum ⁇ -glucan, and the therapeutic effect standard Same as Example 2.
  • Tingling and itching are divided into grades I, II, III, and IV respectively: the scores corresponding to each grade (the higher the score, the more serious the adverse reaction) are as follows:
  • formula IV containing 0.1% Schizophyllum ⁇ -glucan has greater improvement in both adverse reactions, and the improvement in itching is more obvious.
  • the evaluation indicators are as follows:
  • Azelaic acid is a known active ingredient for acne, but its side effects, such as tingling and itching, can seriously affect the patient's experience.
  • the composition of the present invention not only makes the product more effective in treating acne, but also significantly reduces adverse reactions (such as reduced itching and stinging, and shortened duration), and can Improve patient or consumer comfort and compliance.

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Abstract

L'invention concerne une composition pour la peau et son utilisation. En particulier, l'invention concerne l'utilisation d'une composition, la composition étant utilisée pour préparer : (a) un produit cosmétique pour l'élimination de l'acné, ou (b) un médicament pour traiter et/ou prévenir l'acné ; et la composition comprenant : (a) un premier ingrédient actif : l'acide azélaïque ; et (b) un second ingrédient actif : un polysaccharide biologique. Il a été découvert en premier lieu que l'acide azélaïque et le polysaccharide biologique ont un effet synergique sur le traitement de l'acné, la combinaison des deux pouvant réduire de manière considérable les effets secondaires, tels que les picotements et/ou le prurit, causés par l'acide azélaïque, et ceux-ci sont très appropriés pour la préparation de médicaments ou de produits cosmétiques antiacnéiques pour le traitement de l'acné.
PCT/CN2021/122710 2020-10-09 2021-10-08 Composition pour la peau et son utilisation WO2022073484A1 (fr)

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CN116549326A (zh) * 2023-03-30 2023-08-08 广州真润生物科技有限公司 一种高含量壬二酸点痘霜及其制备方法
CN118126836A (zh) * 2024-01-24 2024-06-04 北商加美(北京)科技有限公司 裂褶菌发酵产物滤液、含其皮肤外用剂、及其制备和应用

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