Beauty-acceptable foamable external preparation composition and application thereof

Abstract

The invention relates to the field of skin care, in particular to a cosmetically acceptable foamable external preparation composition and application thereof. The cosmetically acceptable foamable external preparation composition is prepared from the following components: squalane, polydimethylsiloxane, a herba portulacae extract, dipotassium glycyrrhizinate, bisabolol, farnesyl alcohol, panthenol, allantoin, sodium hyaluronate, an orange fruit extract and an anti-acne drug molecule with a high moisturizing effect. The topical pharmaceutical preparation composition for improving skin disease symptoms comprises anti-acne pharmaceutical molecules and various components, and aims at achieving the effects of moisturizing, healing, relieving, resisting bacteria and promoting collagen.

Description

Technical Field

[0001] The present invention relates to the field of skin care, and in particular to a cosmetically acceptable foamable external preparation composition and its application. Background Art

[0002] In the field of skin care, especially for acne problems, consumers are paying more and more attention to the moisturizing effect and overall skin health of the products. The development of effective foamable topical formulations has become a research focus, which aims to improve the skin's moisturizing ability and antibacterial properties while reducing the occurrence and development of acne.

[0003] Chinese patent publication number CN118141762 discloses a foam composition sealed in a container, which includes 2 to 15 parts by weight of an active drug, 10 to 30 parts by weight of a lipid substance, 2 to 15 parts by weight of a surfactant, 10 to 35 parts by weight of diethylene glycol monoethyl ether, 0.2 to 1 parts by weight of disodium azelaic acid, 1 to 5 parts by weight of glycylglycine, 10 to 20 parts by weight of water, and 10 to 20 parts by weight of an aerosol propellant.

[0004] The Chinese patent with the publication number CN307976761S discloses that the design product is used to contain a skin care product containing moist azelaic acid foam. It also describes a kit 1 as a cosmetic packaging bottle, a kit 2 as a cosmetic inner packaging box, and a kit 3 as a cosmetic outer packaging box.

[0005] The Chinese patent with the announcement number CN307358276S discloses a high-quality azelaic acid foam plastic packaging box, which is mainly designed for packaging azelaic acid foam plastic. In addition, a shape and pattern combination and a three-dimensional view for packaging azelaic acid foam plastic are also described.

[0006] US Patent No. US10117812B discloses a foamable formula composition combining a polar solvent and a hydrophobic carrier. The formula composition is claimed to contain up to 20% propylene glycol and 10% polar solvents, which may irritate the skin when used on acne skin.

[0007] Acne sufferers have more skin damage from papules and pustules, making the skin more susceptible to irritation, inflammation, bacterial infection, and more open wounds, which can lead to poor skin healing and dryness that can cause scarring. A damaged barrier can worsen acne by allowing bacteria and irritants to penetrate the skin and cause inflammation. It can also disrupt the balance of natural oils, leading to excess oil production and acne.

[0008] The skin barrier, also known as the epidermal barrier or moisture barrier, is the outermost layer of the skin. It is a protective barrier against external irritants, pollutants and bacteria, and also prevents transepidermal water loss to ensure that the skin remains hydrated.

[0009] The water retention of acne skin helps to heal damaged skin faster and reduce associated symptoms such as inflammation and redness. High moisturizing effects can be achieved by adding multiple ingredients to the formulation. The chemical potential in the formulation is not only the driving factor, but also the "water activity". Water activity is proportional to the flux of the drug. More specifically, drug release from topical dosage forms is not only affected by the viscosity of the formulation and the thermodynamic activity of the drug, but also by the physicochemical properties of the excipients. Highly moisturizing ingredients will retain more water in the skin, thereby affecting water activity.

[0010] Therefore, the drug in the formula must have properties that promote water retention in the skin, provide moisturizing effects, exfoliate and skin healing effects, boost collagen to fill gaps, and reduce odor.

[0011] The existing dipotassium glycyrrhizinate has a soothing effect on the skin and is thought to help relieve inflammation in acne-prone skin. Purslane extract is one of the richest plant sources of omega-3 fatty acids, vitamins and minerals, which can help repair skin damaged by acne. Bisabolol is a natural skin care ingredient extracted from plants with anti-inflammatory and antibacterial properties, making it an ideal ingredient for soothing skin irritation and redness and treating acne and other skin diseases. Orange fruit extract is a source of high levels of vitamin C, a powerful antioxidant that protects the skin from free radical damage and promotes collagen production. Farnesol can inhibit the growth of certain bacteria on the skin by affecting the pH level on the skin surface, creating an environment that is not conducive to bacterial growth.

[0012] Squalane is a saturated oil that increases skin hydration and has anti-inflammatory properties for acne and eczema. Panthenol is a popular ingredient in skincare products due to its ability to improve skin hydration, elasticity and overall appearance. Allantoin aids in hydration, exfoliation and skin healing. Allantoin has been shown to increase collagen production in the skin, promoting skin elasticity and wound healing for younger-looking skin. Sodium hyaluronate provides excellent moisturizing benefits, it attracts water to deeply moisturize and plump the skin and supports collagen.

[0013] Therefore, for acne-prone skin, new compositions need to be developed to promote rapid skin healing, retain skin moisture, promote collagen, and provide moisturizing effects while treating. Summary of the invention

[0014] In order to improve acne symptoms and provide good skin care effects, the present application provides a cosmetically acceptable foamable topical preparation composition and its application, wherein the foamable topical preparation composition includes anti-acne drug molecules and multiple ingredients, aiming to play the role of moisturizing, healing, soothing, antibacterial and promoting collagen.

[0015] In the first aspect, the present application provides a cosmetically acceptable foamable external preparation composition, which adopts the following technical solution: A cosmetically acceptable foamable external preparation composition comprises the following components: squalane, polydimethylsiloxane, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, orange fruit extract, and anti-acne drug molecules with high moisturizing effect.

[0016] Preferably, the anti-acne drug molecules with high moisturizing effect are one or more of azelaic acid, adapalene, tazarotene, trefarotene, retinoic acid, dapsone, benzoyl peroxide, and clindamycin phosphate.

[0017] Preferably, the concentration of the anti-acne drug molecules with high moisturizing effect in the foamable external preparation composition is less than 20% w / w in weight percentage.

[0018] Preferably, the purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol and orange fruit extract are all separated in a specific state, wherein the specific state can be solid, liquid or paste.

[0019] Preferably, the squalane, dimethicone, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, and orange fruit extract are present in any proportion.

[0020] Preferably, in terms of weight percentage, the concentration of squalane is 1-5% w / w, polydimethylsiloxane is 0.5-2% w / w, purslane extract is 0.1-3% w / w, dipotassium glycyrrhizinate is 0.1-3% w / w, bisabolol is 0.5-2% w / w, farnesol is 0.1-1% w / w, panthenol is 1-5% w / w, allantoin is 0.5-2% w / w, sodium hyaluronate is 0.1-2% w / w, and orange fruit extract is 0.5-3% w / w.

[0021] In a second aspect, the present application provides an application of a cosmetically acceptable foamable external preparation composition, using the following technical solution: The invention discloses an application of a cosmetically acceptable foamable external preparation composition, wherein the foamable external preparation composition is used for moisturizing, moisturizing and treating acne.

[0022] Several technical solutions of this application are described in detail as follows: The present application discloses a cosmetically acceptable foamable external preparation composition. The foamable external preparation composition can be an emulsion or a microemulsion. Both the emulsion and the microemulsion include an aqueous phase and an organic carrier phase.

[0023] The term "cosmetically acceptable composition" in this application, such as a formulation composition, is intended to include a product comprising an active substance or a pharmaceutically acceptable salt thereof, and other inert ingredients (cosmetically acceptable excipients). Such cosmetic or pharmaceutical compositions are synonymous with "formulations" and "dosage forms".

[0024] The "emulsion" used in this application refers to a white turbid liquid system in which one liquid (oil or water) is dispersed in another liquid (oil or water) under the action of a surfactant or a mixed surfactant.

[0025] The term "microemulsion" as used herein refers to a transparent to translucent liquid system in which one liquid (oil or water) is dispersed in another liquid (oil or water) system with the aid of a surfactant or a combination of a surfactant and sub-micron spheres.

[0026] The term "cosmetic formulation" as used herein means "any article intended for application, pouring, spraying or ejection onto the human body or any part thereof for cleansing, beautifying, increasing attractiveness or altering the appearance". Cosmetic formulation may be used interchangeably with cosmetic formulation ingredient, dosage form, finished product, carrier or composition.

[0027] The term "external pharmaceutical composition" as used herein refers to a composition used to prevent, alleviate, cure or otherwise treat a target condition or disease.

[0028] As used herein, the term "topical" or "topical administration" or "topical" refers in its conventional sense to the delivery of a topical drug or pharmacologically active agent to the skin or mucous membranes.

[0029] As used herein, the term "subject" or "patient" or "host" refers to a mammal, preferably a human.

[0030] As used herein, the term "treat" or "treatment" of a condition, disorder, or condition means: (1) preventing or delaying the onset of clinical symptoms of the condition, disorder, or condition in a mammal that may be suffering from or susceptible to the condition, disorder, or condition but does not yet develop or show clinical or subclinical symptoms of the condition, disorder, or condition, (2) inhibiting the condition, disorder, or condition, or (3) ameliorating the disease, i.e., causing regression of the condition, disorder, or condition or at least one clinical or subclinical symptom thereof. The benefit to the subject is statistically significant or at least perceptible to the patient or physician.

[0031] As used herein, an "effective amount" or "therapeutically effective amount" of a pharmacologically active agent refers to a drug or agent that is non-toxic but sufficient to produce the desired effect. The "effective amount" varies depending on the compound, the disease and its severity, and the age, weight, physical condition and responsiveness of the mammal to be treated. Therefore, it is not always possible to precisely define an "effective amount". However, one of ordinary skill in the art can determine the appropriate "effective amount" in any case through routine experiments.

[0032] As used herein, the term "humectant" means "a substance used in a formulation that attracts and retains water in the formulation or on the surface of the skin."

[0033] Dipotassium glycyrrhizinate has a soothing effect on the skin and is thought to help relieve skin inflammation. Clinical studies have shown that dipotassium glycyrrhizinate is effective in treating atopic dermatitis or eczema because it reduces redness and irritation.

[0034] Squalane is a saturated oil that is used as a humectant in skincare to help increase hydration, and due to its anti-inflammatory properties, it can help treat acne and eczema.

[0035] Purslane extract is one of the richest plant sources of omega-3 fatty acids, vitamins and minerals that help form the skin. It also contains antioxidant properties to ensure the skin's surface barrier is fully protected from free radical damage such as UV exposure and pollution.

[0036] Bisabolol is a natural skin care ingredient extracted from plants. It has anti-inflammatory and antibacterial properties, making it an ideal ingredient for skin care products. In addition, bisabolol can be used to soothe skin irritation and redness, treat acne and other skin conditions.

[0037] In cosmetics, farnesol is used primarily in deodorants and perfumes. As a deodorant, farnesol works by inhibiting the growth of odor-causing bacteria on the skin. It does this by affecting the pH level on the skin's surface, creating an environment that is unfavorable for bacterial growth.

[0038] Panthenol, also known as vitamin B5, is a water-soluble vitamin that is often used in skin care products. It is derived from pantothenic acid, which is found in foods such as eggs, meat, and whole grains. Panthenol is a common ingredient in skin care products because of its ability to improve skin hydration, elasticity, and overall appearance.

[0039] Allantoin aids in hydration, exfoliation, and skin healing. Allantoin has been shown to increase skin collagen production, promote skin elasticity and wound healing for younger-looking skin. Allantoin is a non-toxic, safe ingredient with minimal side effects when used.

[0040] Sodium hyaluronate is a key ingredient in a variety of skin care products because it provides excellent hydration, draws out moisture, deeply moisturizes and plumps the skin, and supports collagen. Sodium hyaluronate can be used in a variety of skin care products, including serums, creams, gels, lotions, and cleansers.

[0041] Orange fruit extract is a beneficial ingredient in skin care products. Like other citrus fruits, it provides a good dose of vitamin C, a powerful antioxidant that protects the skin from free radical damage and stimulates collagen production.

[0042] In one aspect, the present application discloses a cosmetically acceptable foamable topical formulation composition, comprising an anti-acne drug molecule and a plurality of ingredients, aiming to achieve moisturizing, healing, soothing, antibacterial and collagen-promoting effects.

[0043] On the other hand, the present application discloses a cosmetically acceptable foamable topical preparation composition, comprising an anti-acne drug molecule, moisturizing ingredients such as squalane, polydimethylsiloxane, allantoin, panthenol and sodium hyaluronate, therapeutic ingredients such as purslane extract and bisabolol, soothing ingredients such as dipotassium glycyrrhizinate, antibacterial ingredients such as farnesol, and collagen promoting ingredients such as orange fruit extract.

[0044] In another aspect, the present application discloses a cosmetically acceptable foamable topical preparation composition, comprising an anti-acne drug molecule, squalane, polydimethylsiloxane, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, and orange fruit extract.

[0045] In a specific embodiment of the present application, a cosmetically acceptable foamable topical preparation composition comprises an anti-acne drug molecule, squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, purslane extract, bisabolol, dipotassium glycyrrhizate, farnesol, and orange fruit extract; wherein the anti-acne drug molecule is natural or synthetic or a combination of the two.

[0046] In a most particular embodiment of the present application, a cosmetically acceptable foamable external preparation composition comprises anti-acne drug molecules, as well as squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, purslane extract, bisabolol, dipotassium glycyrrhizate, farnesol, and orange fruit extract; wherein the anti-acne drug molecules are natural or synthetic or a combination of the two, and the concentration of the anti-acne drug molecules is less than 20%.

[0047] In a specific embodiment of the present application, a cosmetically acceptable foamable topical preparation composition comprises an anti-acne drug molecule, squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, bisabolol, dipotassium glycyrrhizinate, farnesol, and orange fruit extract; wherein the anti-acne drug molecule is synthetic.

[0048] In a more specific embodiment of the present application, a cosmetically acceptable foamable topical preparation composition comprises anti-acne drug molecules, squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, purslane extract, dipotassium glycyrrhizinate, farnesol, and orange fruit extract; wherein the anti-acne drug molecules are selected from one or more of azelaic acid, adapalene, tazarotene, trefarotene, retinoic acid, dapsone, benzoyl peroxide, and clindamycin phosphate.

[0049] In a most specific embodiment of the present application, a cosmetically acceptable foamable topical preparation composition includes azelaic acid, squalane, polydimethylsiloxane, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, and orange fruit extract; wherein the concentration of squalane is 1-5% w / w, the concentration of polydimethylsiloxane is 0.5-2% w / w, purslane extract is 0.1-3% w / w, dipotassium glycyrrhizinate is 0.1-3% w / w, bisabolol is 0.5-2% w / w, farnesol is 0.1-1% w / w, panthenol is 1-5% w / w, allantoin is 0.5-2% w / w, sodium hyaluronate is 0.1-2% w / w, and orange fruit extract is 0.5-3% w / w.

[0050] In one aspect of the present application, a cosmetically acceptable foamable topical preparation composition includes an anti-acne drug molecule and a plurality of ingredients having a moisturizing effect; the foamable topical preparation composition is mixed with a liquefied gas propellant to release a breakable foam suitable for topical administration, wherein the gas propellant is selected from one or more of propane, butane, n-butane, carbon dioxide, dimethyl ether, hydrofluorocarbons and nitrogen in an aerosol container.

[0051] In another aspect of the present application, a cosmetically acceptable foamable topical preparation composition comprises an anti-acne drug molecule and a plurality of ingredients (squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, purslane extract, bisabolol, dipotassium glycyrrhizate, farnesol, orange fruit extract); after mixing the foamable topical preparation composition with a liquefied gas propellant, a breakable foam suitable for topical administration can be released, wherein the gas propellant is selected from one or more of propane, butane, n-butane, carbon dioxide, dimethyl ether, hydrofluorocarbons and nitrogen in an aerosol container.

[0052] In another aspect of the present application, a cosmetically acceptable foamable topical formulation composition includes anti-acne drug molecules, wherein the anti-acne drug molecules include one or more of resorcinol, sulfur, salicylic acid, salicylate alpha-hydroxy acid, non-steroidal anti-inflammatory agent benzoyl peroxide, tretinoin, isotretinoin and other retinoid compounds, adapalene, trefarotene, azelaic acid, azelaic acid derivatives, antibiotic preparations (such as erythromycin and clindamycin, zinc salts and zinc salt complexes). The foamable topical preparation composition prepared from anti-acne drug molecules and multiple ingredients (squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, purslane extract, bisabolol, dipotassium glycyrrhizate, farnesol, orange fruit extract) can release a breakable foam suitable for topical medication after mixing with a liquefied gas propellant, wherein the gas propellant is selected from one or more of propane, butane, n-butane, carbon dioxide, dimethyl ether, hydrofluorocarbons and nitrogen in an aerosol container.

[0053] As used herein, the term "propellant" is responsible for intensifying the pressure in the aerosol container, which forces the product out of the container when the valve is opened, and aids in the expulsion of the product by atomization of the contents or generation of foam from the product.

[0054] More specifically, the present application discloses a cosmetically acceptable foamable external preparation composition, which includes azelaic acid and squalane, polydimethylsiloxane, allantoin, panthenol, sodium hyaluronate, purslane extract, bisabolol, dipotassium glycyrrhizate, farnesol, and orange fruit extract. After mixing the composition with liquefied gas propellants propane and butane in an aerosol container, it can release easily breakable foam suitable for topical use.

[0055] In some embodiments, a cosmetically acceptable foamable topical formulation composition is non-flammable, wherein the gas propellant comprises a hydrocarbon; wherein the hydrocarbon is selected from propane, butane, isobutane, or any combination thereof.

[0056] The present application further provides a method for treating, alleviating or preventing a disease in a mammal, comprising applying a therapeutically effective amount of the above composition to an affected target site.

[0057] The present application also discloses evaluating a cosmetically acceptable foamable topical preparation composition on human volunteers for treating, alleviating or preventing skin diseases.

[0058] The present application further provides use of a therapeutically effective amount of the above composition in the manufacture of a medicament.

[0059] This evaluation also included a total epidermal weight loss (TEWL) study on actual human volunteers to assess the water content and water loss of the skin.

[0060] In summary, the present application includes at least one of the following beneficial technical effects: 1. The cosmetically acceptable foamable topical preparation composition can provide excellent moisturizing effect and antibacterial properties. The effective combination of anti-acne drug molecules can significantly improve acne symptoms, while a specific proportion of moisturizers helps to enhance the skin's water retention capacity and barrier function. The synergistic effect of anti-acne drug molecules, squalane, polydimethylsiloxane, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, and orange fruit extract further enhances the soothing and antioxidant effects of the product, thereby comprehensively improving skin health. At the same time, the use of moisturizing and repairing drugs in the form of foaming preparations for external coating can increase the contact area between the drug and the skin, promote the penetration of drug ingredients, and improve the treatment effect; and it is easy to be evenly distributed on the skin surface, ensuring that the drug ingredients can evenly cover the treatment area, improving the uniformity and effectiveness of the treatment. More importantly, acne skin is sensitive and damaged skin, and the foaming preparation drugs can reduce friction and irritation to the skin.

[0061] 2. Anti-acne drug molecules are used to treat acne. Different drug molecules can solve different skin problems. Different drug combinations can play a synergistic role and improve the treatment effect. For example, retinoic acid and benzoyl peroxide are used together. Retinoic acid can improve keratinization of hair follicles, and benzoyl peroxide can be antibacterial and anti-inflammatory. The combination of the two can treat acne more effectively; the combination of azelaic acid and clindamycin phosphate can also enhance the antibacterial and anti-inflammatory effects, and has a better treatment effect on acne.

[0062] 3. Although within a certain range, the increase in the concentration of anti-acne drug molecules may increase their efficacy, the efficacy will not necessarily continue to increase after exceeding a certain concentration. Excessively high concentrations of active ingredients may damage the barrier function of the skin, causing discomfort symptoms such as erythema, itching, burning, pain, and may even lead to serious skin problems such as skin allergic reactions and contact dermatitis. This is because the mechanism of action of drugs is often complex, involving multiple links such as binding to specific receptors and intracellular signal transduction. Excessively high concentrations may cause the binding of drug molecules to receptors to reach saturation, and may even produce inhibitory effects or other adverse reactions, thereby affecting the efficacy of the drug. For most active drug molecules, after a lot of research and practice, a relatively narrow optimal concentration range is usually determined. Within this range, the drug can not only play an effective therapeutic role, but also minimize the occurrence of adverse reactions. Controlling the concentration below 20% w / w is more conducive to finding this optimal balance point and ensuring the effectiveness and safety of the drug. DETAILED DESCRIPTION

[0063] The embodiments of the present application will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present application and should not be considered as limiting the scope of the present application. In the examples, if specific conditions are not specified, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0064] Example 1 The material dosage is shown in Table 1; Table 1: Recipe composition Serial Number Ingredient name Effect of ingredients %w / w 1 Azelaic acid Active Agent 15.00 2 benzoic acid preservative 0.10 3 Cetearyl Alcohol Emulsifier 1.00 4 Dimethyl Isosorbide Penetration enhancers 5.00 5 Medium Chain Triglycerides Emollients 11.00 6 Methylcellulose Viscosity modifier 0.10 7 Mono- and di-glycerides Emulsifier 0.50 8 Propylene glycol Moisturizer 11.00 9 Polyoxyethylene stearate 40 Emulsifier 3.00 10 Polysorbate 80 Emulsifier 1.00 11 Sodium hydroxide pH Adjuster qsto pH 4.5 12 Xanthan gum Viscosity modifier 0.30 13 Purified water Carrier qsto 100% 14 Propane Propellant 2.00 15 Butane Propellant 3.00 16 Isobutane Propellant 3.00 Preparation steps: (a) Prepare the polymer phase: Dissolve benzoic acid in a mixture of purified water and propylene glycol under stirring. Add polysorbate 80 and mix with purified water under stirring. Mix xanthan gum and methylcellulose into dry powders and add to the water mixture under stirring. Hydrate the polymer under stirring for 60 minutes. Heat the polymer phase to a temperature of 70°C.

[0065] (b) Preparation of oil phase: Cetearyl alcohol, dimethyl isosorbide, medium chain triglycerides, monoglycerides, diglycerides and polyoxyethylene stearic acid 40 were heated and mixed at 70°C.

[0066] (c) Emulsification: The oil phase was added to the polymer phase and homogenized using a high shear homogenizer at 70°C.

[0067] (d) Cooling: The bulk material was cooled to a temperature of 50°C while stirring.

[0068] (e) Addition of azelaic acid: Azelaic acid was added to the emulsified powder at 50°C and homogenized using a high shear homogenizer at 50°C for 30 minutes.

[0069] (f) Cooling: The bulk was cooled to a target temperature of 32°C under stirring.

[0070] (g) pH adjustment: The pH value of the bulk material was adjusted to 4.5 using sodium hydroxide solution and stirred for 30 minutes.

[0071] (h) Filling: The bulk material is placed in cans, filled with the propellant propane, butane and isobutane and the container is sealed.

[0072] Example 2 The material usage is shown in Table 2; Table 2: Recipe composition Preparation steps: (a) Prepare the polymer phase: Dissolve benzoic acid in a mixture of purified water and propylene glycol under stirring. Add allantoin, panthenol and polysorbate 80 and mix with purified water under stirring. Mix xanthan gum, methylcellulose and sodium hyaluronate into dry powders and add to the water mixture under stirring. Hydrate the polymer under stirring for 60 minutes. Heat the polymer phase to a temperature of 70°C.

[0073] (b) Preparation of oil phase: Cetearyl alcohol, dimethyl isosorbide, polydimethylsiloxane, medium chain triglycerides, mono- and diglycerides, polyoxyethylene stearate 40 and squalane were heated and mixed at 70°C.

[0074] (c) Emulsification: The oil phase was added to the polymer phase and homogenized using a high shear homogenizer at 70°C.

[0075] (d) Cooling: The bulk material was cooled to a temperature of 50°C while stirring.

[0076] (e) Addition of azelaic acid: Azelaic acid (i.e., azelaic acid) was added to the emulsion at a temperature of 50° C. and homogenized using a high shear homogenizer at a temperature of 50° C. for 30 minutes. Farnesol, bisabolol, dipotassium glycyrrhizinate, purslane extract, and orange fruit extract were added and mixed under homogenization conditions for 10 minutes.

[0077] (f) Cooling: The bulk was cooled to a target temperature of 32°C under stirring.

[0078] (g) pH adjustment: The pH of the bulk was adjusted to 4.5 with sodium hydroxide solution and then mixed for 30 minutes.

[0079] (h) Filling: The bulk material is placed in cans, filled with the propellant propane, butane and isobutane and the container is sealed.

[0080] The difference between the foam formula of Example 2 and Example 1 is: 1. Compared with Example 1, allantoin and panthenol are added in the polymer phase preparation step of Example 2, and sodium hyaluronate is added to the dry powder of the viscosity modifier; 2. Compared with Example 1, squalane with moisturizing function is added in the oil phase preparation step of Example 2; 3. Compared with Example 1, in the emulsification preparation step of Example 2, farnesol, bisabolol, dipotassium glycyrrhizate, purslane extract and orange fruit extract are added, and the mixture is homogenized for 10 minutes.

[0081] Test case 1: Security The probiotic strains were tested for skin irritation using a piglet model. Pigs are one of the main animals used for translational research, and pig skin is similar to human skin in terms of physiology, anatomy, biochemistry, and immunity. Minipigs are often used as test subjects for animal testing to simulate symptoms such as human skin diseases and acne. The foam formulas in Example 1 and Example 2 were applied to the skin of three minipigs at the same dose every day. The clinical symptoms of the animals were observed every day, and the test results were taken before coating, 0.5h, 1h, 4h, 8h, and 24h, and 1 week after continuous coating, and the test results were scored using the Draize scoring system.

[0082] Table 3: Toxicity study results During the entire test process, no erythema or edema occurred in the area of ​​the mini pigs coated with the foam formula, and the Draize score was 0. This indicates that the foam formulas in Examples 1 and 2 are both qualified and safe in the animal skin model.

[0083] Test Example 2: Research on animal transepidermal water loss rate, human transepidermal water loss rate and skin water content 2.1. Research on animal transepidermal water loss rate In a controlled laboratory environment, the foam formulations of Example 1 and Example 2 were subjected to an animal transepidermal water loss test on six miniature pigs. The formulation samples of Example 1 and Example 2 were applied to two specific handprint-sized marked areas on the same miniature pig for two weeks, and the TEWL values ​​were measured on the first day of application of the foam formulation, one week of application, and two weeks of application.

[0084] Table 4: Results of animal transepidermal water loss study The table of the results of the animal transepidermal water loss study shows that after two weeks of continuous use of Example 1 and Example 2, the average TEWL of the mini pigs using Example 1 was 20.81, which was greater than the average TEWL of the mini pigs using Example 2, which was 16.11. Compared with before the use of the drug, both had a certain hydrating effect, among which the hydrating effect of Example 2 was better than that of Example 1.

[0085] 2.2 Study on human transepidermal water loss rate The foam formulations of Example 1 and Example 2 were subjected to a four-week human test, and the TEWL values ​​were measured. A total of 60 healthy subjects with an average age of 32 years participated in the test, including 44 females and 16 males. There were 8 subjects aged 18 to 25 years, 12 subjects aged 26 to 30 years, 20 subjects aged 31 to 35 years, and 20 subjects aged 36 to 40 years. The subjects of each age group were equally divided, and finally two groups were formed.

[0086] Table 5: Human Trans-epidermal Water Loss Study (TEWL) The table of the human transepidermal water loss study shows that after four weeks of continuous use of Example 1 and Example 2, the average TEWL of healthy subjects using Example 1 was 25.18, which was greater than the average TEWL of healthy subjects using Example 2, which was 23.09. Compared with before the use of the drug, both had a certain hydrating effect. However, the data showed that the hydrating effect of Example 2 was better than that of Example 1.

[0087] 2.3. Research on skin moisture content After using Example 1 and Example 2 continuously for four weeks, the skin moisture content of the subjects was tested and analyzed.

[0088] Table 6: Skin moisture content research results The table of the skin moisture content study results shows that after four weeks of continuous use of Example 1 and Example 2, the average skin moisture content of healthy subjects using Example 1 was 53.97%, an increase of 4.85% compared to the average skin moisture content of 49.12% before Example 1 was not applied; the average skin moisture content of healthy subjects using Example 2 was 58.64%, an increase of 9.66% compared to the average skin moisture content of 48.98% before Example 2 was not applied.

[0089] The above results show that under the same test conditions, the water replenishing effect of Example 2 is better than that of Example 1.

[0090] Test Example 3: Study on the effect of papule repair After using the formula examples 1 and 2 for four weeks, the number of papules on the subjects' skin was also examined. The results of the papule number study are as follows: Table 7: Results of the study on the number of papules The table of the skin moisture content study results shows that after four weeks of continuous use of Example 1 and Example 2, the number of facial papules of the subjects using Example 1 decreased by 62.36%, while the number of facial papules of the subjects using Example 2 decreased by 77.88%, which is a significant increase compared to the number of facial papules of the subjects using Example 1. The results show that the effect of Example 2 in eliminating acne is better than that of Example 2.

[0091] Test Example 4: Evaluation of Acne Repair Results After four weeks of use, the test subjects evaluated the two examples of the foam formulations, and the evaluation results were as follows: Table 8: Results of experience study after using different formulas According to the self-assessment analysis of the subjects, the number of facial acne was significantly reduced. The acne area, acne range, acne size and overall evaluation were significantly improved. And between Example 1 and Example 2, the subjects preferred Example 2.

[0092] The best embodiment of the present application is Embodiment 2, and the medicine of the best embodiment has good acne removal effect, as well as oil control, moisturizing and repairing effects on both male and female patients. As the use time of this product increases, the damaged skin environment of the patient's face is further improved, showing a higher repair rate. No acne rebound phenomenon occurs during use, further reducing the occurrence of sequelae.

[0093] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A cosmetically acceptable foamable external preparation composition, characterized in that: Includes the following components: squalane, polydimethylsiloxane, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, orange fruit extract, and anti-acne drug molecules with high moisturizing effect.

2. A cosmetically acceptable foamable external preparation composition according to claim 1, characterized in that: The anti-acne drug molecules with high moisturizing effect are one or more of azelaic acid, adapalene, tazarotene, trefarotene, retinoic acid, dapsone, benzoyl peroxide, and clindamycin phosphate.

3. A cosmetically acceptable foamable external preparation composition according to claim 1, characterized in that: In terms of weight percentage, the concentration of the anti-acne drug molecule with high moisturizing effect in the foamable external preparation composition is less than 20% w / w.

4. A cosmetically acceptable foamable external preparation composition according to claim 1, characterized in that: The purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol and orange fruit extract are all separated in a specific state, wherein the specific state can be solid, liquid or paste.

5. A cosmetically acceptable foamable external preparation composition according to claim 1, characterized in that: The squalane, dimethicone, purslane extract, dipotassium glycyrrhizinate, bisabolol, farnesol, panthenol, allantoin, sodium hyaluronate, and orange fruit extract are present in any proportion.

6. A cosmetically acceptable foamable external preparation composition according to claim 1, characterized in that: In terms of weight percentage, the concentration of squalane is 1-5% w / w, polydimethylsiloxane is 0.5-2% w / w, purslane extract is 0.1-3% w / w, dipotassium glycyrrhizinate is 0.1-3% w / w, bisabolol is 0.5-2% w / w, farnesol is 0.1-1% w / w, panthenol is 1-5% w / w, allantoin is 0.5-2% w / w, sodium hyaluronate is 0.1-2% w / w, and orange fruit extract is 0.5-3% w / w.

7. A use of the cosmetically acceptable foamable external preparation composition according to any one of claims 1 to 6, characterized in that: The foamable external preparation composition is used for moisturizing, moisturizing and treating acne.

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