CN110974830A - External composition for preventing, relieving or treating skin allergy and application thereof - Google Patents
External composition for preventing, relieving or treating skin allergy and application thereof Download PDFInfo
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- CN110974830A CN110974830A CN201911361962.9A CN201911361962A CN110974830A CN 110974830 A CN110974830 A CN 110974830A CN 201911361962 A CN201911361962 A CN 201911361962A CN 110974830 A CN110974830 A CN 110974830A
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
- A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
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Abstract
The invention discloses an external composition which is safe, environment-friendly, free of side effect and stimulation, can effectively prevent, relieve or treat skin allergy, and has anti-inflammatory, antibacterial and anti-stimulation functions. The composition comprises tetrahydropyrimidine or a derivative thereof, hyaluronic acid or a derivative thereof, a biosurfactant and epsilon-polylysine as a central composition, and optionally one or more vitamins, and optionally one or more natural plant components. The composition is provided in the form of a cosmetic, a medical device, a pharmaceutical, or as an additive to the aforementioned products.
Description
Technical Field
The invention belongs to the technical field of cosmetics and medicines, and particularly relates to an external composition for preventing, relieving or treating skin allergy, resisting inflammation, bacteria and irritation and application thereof.
Background
The skin covers the surface of the human body, is the largest organ of the human body, is directly contacted with the external environment, prevents various tissues and organs in the human body from being damaged and invaded by factors such as machinery, physics, chemistry, biology and the like, simultaneously prevents various nutrient substances, moisture and electrolytes in the human body from being lost, plays a role in barrier and plays an important role in maintaining the stability of the internal environment of the human body. The skin barrier is mainly composed of the sebaceous membrane and the stratum corneum. The sebaceous membrane is a transparent film covering the surface of the skin, is mainly formed by emulsifying sebum secreted by sebaceous glands, lipid produced by stratum corneum cell disintegration and sweat secreted by sweat glands, forms a protective film on the surface of the skin, is weakly acidic, has water-retaining and certain anti-inflammatory effects, and is used for keeping the health of the skin.
The damaged sebum membrane can cause the immunity of the skin to be reduced, the water locking function to be weakened, the skin to become dry, pruritus, molting, red swelling and even pigmentation to become sensitive. Dermatitis, eczema and skin allergies are a common class of skin barrier deficiency diseases we have seen in our daily lives. Dermatitis generally refers to an inflammatory disease of the skin, and eczema is a general name for dermatitis with a temporarily undefined etiology. The name of dermatitis and eczema, which are commonly called in our lives, is allergic dermatosis in a medically standardized way. Allergic skin diseases are skin diseases caused by allergens, and the skin diseases have wide induction factors, including various infectious or non-infectious substances in and out of human bodies, human neuropsychiatry and emotion, various environmental factors such as temperature, humidity, ultraviolet rays and the like, and the etiology and clinical manifestations of the allergic skin diseases are complex and various. The clinical symptoms mostly include: itch of skin, papules, blisters, wheal, erosion, erythema, scaling, lichenification, etc. The one with relatively clear pathogenesis or clinical features of allergic skin diseases is generally called certain dermatitis, such as contact dermatitis, allergic dermatitis, neurodermatitis, seborrheic dermatitis, solar dermatitis, viral dermatitis, fungal dermatitis, bite dermatitis and the like.
There are many different cosmetics, medical devices and drugs available on the market for the prevention, alleviation and treatment of the aforementioned allergic skin diseases. These preparations usually contain steroids, antibiotics, antifungal, antihistamine components, analgesics and/or other synthetic active substances and auxiliaries. These agents treat skin inflammation, infection or allergy by modulating the body's immune function, attacking parasites, bacteria, viruses or fungi, anti-allergic mechanisms, etc. However, the products containing the effective substances have the following disadvantages while achieving relief and treatment:
① do not promote skin tissue cell repair to reestablish the skin barrier, but instead require the body's own immune system and specific expression factors to reestablish the barrier.
② the use of the above preparation for treating skin barrier deficiency diseases has strong side effects and/or causes anaphylaxis in human body, such as erythema, acne, pimple, skin pruritus, wound healing disorder, etc., and adverse reaction after application is part of skin irritation.
When the preparation is used for relieving or treating skin barrier defect diseases, the reconstruction of skin barrier function depends on the activity of skin cells of the organism per se, and internal secretion is regulated, so that skin tissue cell regeneration is promoted. However, these agents often have reduced skin cell viability after use due to possible side effects, and the skin can only very slowly or not at all maintain or re-establish the skin barrier, thereby being more susceptible to repeated allergic reactions and formation of a vicious circle.
In order to remedy the defects of the preparation, a plurality of researchers research and patent on the utilization of Chinese herbal medicine components as anti-inflammatory and allergy-eliminating effective components, for example, CN 1596953A relates to a medicament for treating allergic skin diseases, and provides a compound medicament for treating the allergic skin diseases, which is prepared from the following components: 10-50 parts of lotus seed, 5-10 parts of radix sophorae flavescentis, 10-20 parts of salvia miltiorrhiza, 5-10 parts of divaricate saposhnikovia root, 5-10 parts of cortex dictamni, 5-10 parts of purslane, 5-10 parts of spina gleditsiae and 1-6 parts of raw liquorice. CN 104984046A relates to a traditional Chinese medicine external preparation for treating allergic skin diseases and a preparation method thereof, and discloses a traditional Chinese medicine external preparation for treating allergic skin diseases, which is prepared from twelve medicinal materials of rhizoma drynariae, cassia twig, dark plum, chrysanthemum morifolium, fructus forsythiae, scutellaria baicalensis, lily, Chinese date, polygonatum, radix pseudostellariae, semen cuscutae and fructus lycii. CN 105233111A relates to a cream-shaped medicine for treating allergic skin diseases and a preparation method thereof, wherein the formula of the disclosed cream-shaped medicine for treating allergic skin diseases comprises the following components: 5-10g of saussurea involucrate, 10-15g of esculenta, 12-20g of rumex japonicus, 6-12g of radix stemonae, 4-10g of aloe, 2-5g of radix euphorbiae lantu, 10-30g of pseudolarix, 5-11g of radix sophorae flavescentis, 0.8-1.5g of pearl powder, 7-16g of cortex dictamni, 3-10g of spina gleditsiae, 3-12g of bistort rhizome, 3-10g of Chinese gall, 10-20g of emilia sonchifolia, 4-10g of fructus cnidii, 4-10g of typhonium giganteum, 7-15g of fructus kochiae, 10-30g of herba cistanches, 10-60g of glabrae rhizoma, 4-10g of golden cypress, 15-35g of ilex rotundu. Although the traditional Chinese medicine composition has the effects of diminishing inflammation, relieving itching, relieving pain and the like, avoids side effects brought by conventional preparations to a certain extent, has the advantages of safety, mildness and no toxic or side effect, and has an unobvious effect on the aspect of reconstructing skin barriers.
Disclosure of Invention
The invention aims to overcome the defects of the prior art, and provides a safe and mild, natural low-allergy, non-irritant and side-effect-free external composition which can prevent, relieve or treat skin allergy, has good anti-inflammatory, antibacterial and anti-irritant effects, and has obvious effects on repairing damaged skin and reconstructing skin barrier function.
It is another object of the present invention to provide a skin care product prepared using the above composition.
The invention also provides another application of the composition, namely the composition is added into the existing medical appliance products or medicines for treating dermatitis, so as to promote the repair speed of damaged skin and shorten the treatment period of the products; or added into the existing medical appliance product or medicine for treating dermatitis, and the common emulsifier is replaced by the safe and non-irritant surfactant of natural biological source, thereby eliminating the irritation of the conventional emulsifier to the skin, relieving the anaphylactic reaction and reducing the risk of side effect.
The invention adopts the following specific technical scheme.
1. A composition for external use for preventing, alleviating or treating skin allergy comprises 0.1-10% by mass of tetrahydropyrimidine or a derivative thereof, 0.1-20% by mass of hyaluronic acid or a derivative thereof, 0.1-5% by mass of a biosurfactant, and 0.01-0.1% by mass of epsilon-polylysine, with the balance being water or other base materials.
2. The composition for external use according to item 1, for preventing, alleviating or treating skin allergy, characterized in that the derivative of tetrahydropyrimidine is hydroxytetrahydropyrimidine.
3. The composition for external use according to item 1 or 2, for preventing, alleviating or treating skin allergy, wherein the content of the tetrahydropyrimidine or derivative thereof is 2% to 5%.
4. The composition for external use according to item 1, for preventing, alleviating or treating skin allergy, wherein the hyaluronic acid or derivative thereof has a molecular weight of 1 x 103Da-4×105Da。
5. The composition for external use according to item 4, wherein the hyaluronic acid or the derivative thereof is at least one selected from hyaluronic acid or a salt thereof, and a hyaluronic acid derivative obtained by etherification, esterification, amidation, acetalization, and acetylation of a hydroxyl group and a carboxyl group of hyaluronic acid.
6. The external composition for preventing, alleviating or treating skin allergy according to item 1, 4 or 5, wherein the content of hyaluronic acid or a derivative thereof is 5% to 10%.
7. The composition for external use according to item 1, for preventing, alleviating or treating skin allergy, characterized in that the biosurfactant comprises glycolipid and/or lipopeptide.
8. The external composition for preventing, alleviating or treating skin allergy according to item 1, wherein the biosurfactant is at least one selected from the group consisting of sophorolipids, sucrose lipids, rhamnolipids, trehalose glycolipids, mannosylerythritol lipids, surfactin, iturin, muskonein, and lichenin.
9. The composition for external use for preventing, alleviating or treating skin allergy according to item 1, 7 or 8, wherein the content of the biosurfactant is 1% to 2%.
10. The composition for external use according to item 1, for preventing, alleviating or treating skin allergy, wherein the content of epsilon-polylysine is 0.05%.
11. The composition for external use for preventing, alleviating or treating skin allergy according to item 1, further comprising one or more vitamins in an amount of 0.1% to 3% by mass.
12. The composition for external use according to item 11, for preventing, alleviating or treating skin allergy, wherein the content of vitamin is 2%.
13. The composition for external use according to item 11 or 12, for preventing, alleviating or treating skin allergy, wherein the vitamin comprises at least one of vitamin B5, vitamin C and vitamin E.
14. The composition for external use according to item 1, wherein the composition further comprises one or more natural plant ingredients in an amount of 0.1% to 5% by mass.
15. The composition for external use according to item 1, for preventing, alleviating or treating skin allergy, characterized in that the content of the natural plant ingredient is 2%.
16. The composition for external use according to item 14 or 15, for preventing, alleviating or treating skin allergy, characterized in that the natural plant ingredient is at least one selected from the group consisting of chamomile extract, licorice extract, dandelion extract and moutan bark extract.
17. The composition for external use according to item 16, for preventing, alleviating or treating skin allergy, characterized in that the natural plant components are chamomile extract: and (3) liquorice extract: dandelion extract: cortex moutan extract is a mixture of 3:3:1: 3.
18. A skin care product comprising the external composition for preventing, alleviating or treating skin allergy according to any one of claims 1 to 17.
19. A medical device comprising the topical composition for preventing, alleviating or treating skin allergy of any one of items 1 to 17.
20. A pharmaceutical product comprising the external composition for preventing, alleviating or treating skin allergy according to any one of items 1 to 17.
21. A skin care preparation for preventing and relieving skin allergy, which is characterized in that the skin care preparation is prepared from the external composition of items 1 to 17 with addition of a conventional base for skin care preparations.
22. Use of the external composition for preventing, alleviating or treating skin allergy according to any one of items 1 to 17 for the preparation of a skin care product, characterized in that a base commonly used for skin care products is added to the external composition while an emulsifier commonly used for skin care products is removed.
23. Use of the composition for external use for preventing, alleviating or treating skin allergy according to any one of items 1 to 17 for the preparation of a medical device product or a pharmaceutical product for treating dermatitis, characterized in that the composition for external use is added to an existing medical device product or pharmaceutical product for treating dermatitis while replacing a common emulsifier in the existing medical device product or pharmaceutical product for treating dermatitis with a biosurfactant.
The external composition provided by the invention can exert the following effects: the skin care and whitening cream can care, nourish and whiten skin, diminish inflammation, relieve itching, resist bacteria, relieve allergy, improve skin cell activity, accelerate skin wound repair, accelerate skin barrier regeneration, prevent scars, acne marks and pigmentation and quickly improve the skin epidermis state.
Drawings
Fig. 1 shows the effect of the topical composition on skin barrier repair function.
Detailed Description
The present invention will be described in detail below.
The invention provides an external composition for preventing, relieving or treating skin allergy, which comprises 0.1-10% of tetrahydropyrimidine or derivatives thereof, 0.1-20% of hyaluronic acid or derivatives thereof, 0.1-5% of biosurfactant, 0.01-0.1% of epsilon-polylysine and the balance of water or matrix in percentage by mass.
The external composition for preventing, alleviating or treating skin allergy of the present invention uses tetrahydropyrimidines, such as tetrahydropyrimidine or derivatives thereof, as a main component. The tetrahydropyrimidine is a compatible solute for regulating osmotic pressure in a bacterial body, is compatible with metabolism in cells, does not influence the function or physiological process of biological macromolecules of the cells, has good protection effect on the cells and the biological macromolecules (biomembranes, proteins, enzymes and nucleic acids) under the stimulation of adverse environments such as high temperature, high salt, freezing, drying, radiation and the like, and can also be applied to the skin of human beings, so the tetrahydropyrimidine can be applied to the fields of cosmetics, cytoprotective agents, biological agent stabilizers, pharmaceutical preparations and the like. The tetrahydropyrimidine has strong hygroscopicity, and can promote stratum corneum hydration and relieve dry skin. The tetrahydropyrimidine can reduce the expression of proinflammatory factors, thereby blocking inflammatory reaction and preventing, relieving or treating skin inflammation. The research proves that the tetrahydropyrimidine can also protect immune cells of the skin and improve the self-immune capability of the skin. The tetrahydropyrimidine activates the heat stress reaction of cells by activating the expression of heat stress protein genes, so that the protection and the repair of cells and tissues can be carried out, and the tolerance of the cells is improved.
Tetrahydropyrimidine may be used in the present invention, and derivatives thereof may also be used. As the derivative of tetrahydropyrimidine, hydroxytetrahydropyrimidine is preferably used. The content of tetrahydropyrimidine or a derivative thereof used in the external composition for preventing, alleviating or treating skin allergy of the present invention is preferably 0.1% to 10% by mass, more preferably 2% to 5% by mass.
The external composition for preventing, alleviating or treating skin allergy of the present invention uses a hyaluronic acid-based substance, such as hyaluronic acid or a derivative thereof, as another main component. The hyaluronic acid is a linear high-molecular acidic mucopolysaccharide composed of N-acetylglucosamine and glucuronyl disaccharide units, is widely present in living bodies, and is a main component constituting an intercellular substance and an extracellular matrix. Hyaluronic acid with different molecular weights has multiple physiological functions, including functions of moisturizing, diminishing inflammation, promoting wound healing, improving joint function, a drug carrier and the like, and is widely applied to the fields of cosmetics, health-care food, medicines and the like. The hyaluronic acid or a derivative thereof used in the present invention includes hyaluronic acid or a salt thereof, and a hyaluronic acid derivative obtained by etherification, esterification, amidation, acetalization, acetylation, or the like of a hydroxyl group or a carboxyl group of hyaluronic acid.
The molecular weight of hyaluronic acid has great influence on its bioactivity, and hyaluronic acid with too high molecular weight has poor permeability and is not easy to be absorbed by skin, and the molecular weight of 1 × 10 is preferably used in the invention3Da-4×105Da hyaluronic acid or its derivative, preferably with molecular weight of 5 × 103Da-8×104Da. The hyaluronic acid or a derivative thereof used in the external composition for preventing, alleviating or treating skin allergy of the present invention is contained in an amount of 0.1% to 20% by mass, more preferably 5% to 10% by mass.
The external composition for preventing, alleviating or treating skin allergy of the present invention further comprises a biosurfactant. The biosurfactant is an amphoteric compound having surfactant characteristics, such as glycolipid, lipopeptide, neutral lipid derivative, fatty acid, phospholipid and the like, which are produced by various microorganisms such as bacteria, yeast and fungi. Compared with chemical surfactants, biosurfactants have many advantages, such as safety, no toxicity, no irritation to skin, biodegradability, good biocompatibility, lower critical micelle concentration (cmc), stable activity under extreme pH, temperature and salinity conditions, and diversified bioactivities, such as antibacterial activity, antiviral activity, insecticidal activity, and the like. The biosurfactant has broad-spectrum antifungal effect and certain antibacterial effect, the antibacterial mechanism of the biosurfactant is different from that of common antibiotics, pores can be formed on cell membranes of microorganisms, cell contents flow out to die or chelate into one and divalent cations, so that the activities of various enzymes are inhibited, and drug resistance is not easy to generate due to nonspecific antibiosis. The biosurfactant is added into products in the forms of milk, paste and cream, not only plays the role of an emulsifier, but also has certain antibacterial property, and the dosage of a preservative in the products can be reduced. The biosurfactant used in the present invention preferably comprises glycolipids and/or lipopeptides, more preferably at least one of sophorolipids, sucrose lipids, rhamnolipids, trehalose glycolipids, mannosylerythritol lipids, surfactin, iturin, erucin, lichenin. The content of the biosurfactant in the external composition for preventing, alleviating or treating skin allergy of the present invention is preferably 0.1% to 5% by mass, more preferably 1% to 2% by mass.
The external composition for preventing, alleviating or treating skin allergy of the present invention further comprises epsilon-polylysine. The epsilon-polylysine is a homotype monomer polymer containing 25-30 lysine residues. The epsilon-polylysine has wide antibacterial spectrum, has good antibacterial effect on gram-positive bacteria, gram-negative bacteria, saccharomycetes and mould and also has certain inhibitory effect on some heat-resistant bacillus and viruses. It can be decomposed into L-lysine in human body, and L-lysine is one of 8 amino acids necessary for human body. The bacteriostasis mechanism of epsilon-base polylysine is mainly characterized by destroying the cell membrane structure of microorganisms, causing the contents of cells to flow out, and finally leading to cell death. The content of epsilon-polylysine used in the external composition for preventing, alleviating or treating skin allergy of the present invention is preferably 0.01% to 0.1% by mass, and may be 0.05% for example.
The composition for external use for preventing, alleviating or treating skin allergy of the present invention may optionally further comprise one or more vitamins, preferably vitamin B5, vitamin C and vitamin E. Vitamin B5, vitamin C and vitamin E can improve dry, rough and desquamation skin, relieve itching and treat erythema symptoms related to various skin diseases, eliminate damage of free radicals generated in skin to skin, and enhance skin barrier function. The content of the vitamin in the external composition is preferably 0.1% to 3% by mass, and may be 2% for example.
The external composition for preventing, alleviating or treating skin allergy according to the present invention may further optionally comprise one or more natural plant ingredients. The natural plant component is preferably one or more of chamomile extract, licorice extract, dandelion extract and cortex moutan extract. The extracts of flos Matricariae Chamomillae, herba Taraxaci and cortex moutan have antibacterial, antiinflammatory and immunity enhancing effects, and the extract of Glycyrrhrizae radix has antiinflammatory and antiallergic effects. As the natural plant component, it is preferable to use a chamomilla extract: and (3) liquorice extract: dandelion extract: cortex moutan extract is a mixture of 3:3:1: 3. The content of the natural plant component in the external composition is preferably 0.1% to 5% by mass, and may be 2% for example.
The composition for external use for preventing, alleviating or treating skin allergy of the present invention further contains water or a base, and for example, purified water can be used. Examples of the base include oily bases, higher fatty alcohols (acids or esters), and emulsifiers. The emulsifier includes monovalent metal soap, potassium, sodium and ammonium salts of stearic acid, oleic acid, palmitic acid, lauryl sulfuric acid, etc., triethanolamine stearate, sulfohydrogenated castor oil, sodium stearate sulfate, sodium cetyl sulfate, etc.
The external composition for preventing, alleviating or treating skin allergy of the present invention may be used in various forms, for example, in the form of cosmetics, medical devices, medicines or additives to the aforementioned products. Thus, the present invention also provides skin care products, medical devices and medicines comprising the external composition.
The external composition for preventing, relieving or treating skin allergy can be used for preparing a skin care product, the skin care product is prepared by adding a common matrix of the skin care product into the external composition, and simultaneously removing a common emulsifier in the skin care product. The common matrix is a substance forming a skin care product matrix, reflects the main properties and functions of the skin care product and dominates the dosage form and properties of the skin care product. The common matrix comprises oil (such as animal and vegetable oil and fat and derivatives, and natural mineral oil wax), powder (such as pulvis Talci, Kaolin, bentonite, and titanium dioxide), colloid (such as polyvinyl alcohol and sodium carboxymethylcellulose), and solvent (such as water, alcohols, and esters). The commonly used emulsifier is a substance which enables two mutually insoluble liquids to form a heterogeneous uniform dispersion system and keep stable, and the commonly used emulsifier comprises monovalent metal soap, potassium, sodium and ammonium salts of stearic acid, oleic acid, palmitic acid, lauryl sulfuric acid and the like, triethanolamine stearate, sulfohydrogenated castor oil, sodium stearate sulfate, sodium cetyl sulfate and the like.
The external composition for preventing, alleviating or treating skin allergy of the present invention may be added to existing medical devices or drugs for treating dermatitis, while replacing the conventional emulsifier in the existing medical devices or drugs for treating dermatitis with the above-mentioned biosurfactant.
The external composition for preventing, alleviating or treating skin allergy of the present invention can be used in cosmetics and dermatitis pharmaceuticals for topical application to care for allergic skin which has problems of dryness, itching, pain, scaling, etc., or to prevent the above problems from occurring on the skin.
The invention has the following beneficial effects:
(1) surfactants or emulsifiers are a type of emulsifying base commonly used in most cosmetics, medical devices and drugs, and most surfactants are chemically synthesized substances, which cause severe irritation problems to skin and mucous membranes, such as several commonly used chemical surfactants, sodium alkylbenzenesulfonate (LAS), sodium laureth sulfate (AES), Sodium Dodecyl Sulfate (SDS), and the like. The irritation or sensitization of chemical surfactants and their by-products during synthesis to the skin and mucous membranes is mainly caused by three factors: dissolution, infiltration and adsorption of proteins. The dissolution effect refers to the dissolution of the surfactant to the moisturizing components, intercellular lipids and free amino acids and fats in the stratum corneum of the skin; the penetration is a percutaneous penetration of a surfactant, which is considered to be one of causes of various inflammations of the skin; the surfactant can cause protein denaturation and change skin pH condition by adsorption of protein. The invention uses the biosurfactant to replace the commonly used surfactants or emulsifiers at present, is used in products in the forms of milk, paste and cream, not only plays the role of the emulsifiers, but also has certain antibacterial property, and can reduce the dosage of the preservative in the products.
(2) The vitamins in the external composition improve the problems of dry, rough and desquamation of the skin, have the effects of relieving itching and treating erythema, and can also eliminate the damage of free radicals generated in the skin to the skin and strengthen the barrier function of the skin. The extract of flos Matricariae Chamomillae, herba Taraxaci, cortex moutan and Glycyrrhrizae radix can also be added to provide antibacterial, antiinflammatory, immunity enhancing, and antiallergic effects.
(3) The external composition provided by the invention is safe and mild in components, natural and non-irritant, is used for caring skin, preventing, relieving or treating skin allergy, can preserve moisture, resist inflammation, relieve irritation, accelerate repair and strengthen skin barrier function, enhance immunocompetence of skin cells, inhibit bacteria, has no side effect, can generate synergistic interaction among the components, and is suitable for short-term or long-term use by various crowds.
Examples
The present invention is further illustrated by the following examples. The following examples of the present invention are merely illustrative of specific embodiments for carrying out the present invention and are not to be construed as limiting the invention. Any other changes that do not depart from the gist of the invention are intended to be equivalent and fall within the scope of the invention.
The experimental methods used in the following examples are conventional methods unless otherwise specified, and materials, reagents and the like used therein are commercially available without further specification.
Example 1
0.1g of tetrahydropyrimidine and 20g of sodium hyaluronate (molecular weight 1X 10)3Da), 5g surfaceDissolving 0.01g of epsilon-polylysine in purified water, diluting to 100mL, and mixing to obtain the external composition 1 for preventing, relieving or treating skin allergy.
Example 2
10g of tetrahydropyrimidine and 0.1g of sodium hyaluronate (molecular weight 4X 10)5Da), 0.1g of rhamnolipid and 0.1g of epsilon-polylysine are dissolved in purified water, the volume is adjusted to 100mL, and the components are uniformly mixed to prepare the external composition 2 for preventing, relieving or treating skin allergy.
Example 3
5g of hydroxytetrahydropyrimidine, 10g of acetylated hyaluronic acid (molecular weight 8X 10)4Da), 2g of surfactant and 0.05g of epsilon-polylysine are dissolved in purified water, the volume is adjusted to 100mL, and the components are uniformly mixed to prepare the external composition 3 for preventing, relieving or treating skin allergy.
Example 4
2g of tetrahydropyrimidine and 5g of sodium hyaluronate (molecular weight 5X 10)3Da), 1g of surfactant, 0.05g of epsilon-polylysine, 3g of vitamin B5, 5g of natural plant components (chamomile extract: and (3) liquorice extract: dandelion extract: the cortex moutan extract (3: 3:1:3) is dissolved in purified water, and the volume is fixed to 100mL, and the mixture is uniformly mixed to prepare the external composition 4 for preventing, relieving or treating skin allergy.
Example 5
2g of tetrahydropyrimidine and 5g of sodium hyaluronate (molecular weight 5X 10)3Da), 1g of surfactant, 0.05g of epsilon-polylysine, 0.1g of vitamin E, 0.1g of natural plant ingredients (chamomile extract: and (3) liquorice extract: dandelion extract: the cortex moutan extract (3: 3:1:3) is dissolved in purified water, and the volume is fixed to 100mL, and the mixture is uniformly mixed to prepare the external composition 5 for preventing, relieving or treating skin allergy.
Example 6
2g of tetrahydropyrimidine and 5g of sodium hyaluronate (molecular weight 5X 10)3Da), 1g of surfactant, 0.05g of epsilon-polylysine, 1g of vitamin B5, 1g of vitamin C, 2g of natural plant components (chamomile extract: and (3) liquorice extract: dandelion extract: dissolving cortex moutan extract 3:3:1:3) in purified water, diluting to 100mL, and mixingA composition for external use for preventing, alleviating or treating skin allergy 6.
TABLE 1 formulations for preparing compositions for external use in examples 1-6
Extract of chamomile: and (3) liquorice extract: dandelion extract: cortex moutan extract (mass ratio) 3:3:1:3
The compositions for external use 1 to 6 (hereinafter referred to as compositions 1 to 6) prepared in examples 1 to 6 were tested for safety, antibacterial property and skin barrier repair property as follows.
Example 7 cytotoxicity assay
Detection standard: GB/T16886.5-2017 medical device biology evaluation part 5: in vitro cytotoxicity test (ISO 10993-5:2009, IDT) and keratinocyte test of acute toxicity of cosmetics of SNT 2328-2009, national entry and exit inspection and quarantine industry Standard of the people's republic of China.
Detection indexes are as follows: cell proliferation rate
The detection method comprises the following steps: WST-1 method.
Equipment used in the experiment: inverted microscope (OLYMPUS, CKX41), clean bench (Beijing Dong gang Harr apparatus manufacturing Co., Ltd., SCB-1520), carbon dioxide incubator (SANYO), digital display constant temperature water bath (Tan City middle and large apparatus factory), constant temperature microplate rapid oscillator (Haimen Kara medical apparatus factory, Haimen City), microplate reader (BIO-RAD), etc.
Sample preparation: the purified water in the compositions 1-6 is replaced by DMEM high-glucose culture solution containing 10% fetal calf serum to prepare cell serum culture solutions containing different compositions, and the cell serum culture solutions are sterilized by filtration through a 0.22 mu m filter membrane for later use.
The experimental process comprises the following steps: taking mouse embryo fibroblast BALB/3T3 in logarithmic growth phase at 5X 104The cells were inoculated into a 96-well plate at a density of 100uL per well, and the culture system was DMEM high-glucose medium supplemented with 10% fetal bovine serum. The inoculated cells were placed in a carbon dioxide incubator at 37 ℃ with 5% CO2Culturing for 24 hr, discarding culture solution, and changing to 100 μ L of the cell serum culture medium containing the composition and the serum culture medium containing no composition were used as normal controls. After culturing each composition in 6 parallel wells for 48h, the WST-1 method is adopted to detect the relative proliferation rate of the cells. The relative proliferation rate (RGR) is the ratio of the absorbance of the sample group to the absorbance of the normal control group. Samples were considered cytotoxic when RGR was below 70% as required by GB/T16886.5-2017.
TABLE 1 cytotoxicity of compositions 1-6
As shown in Table 1, the relative cell proliferation rate (RGR) of the compositions of examples 1-6 is higher than 70%, indicating no significant cytotoxicity, which indicates that the compositions provided by the present invention are safe and non-toxic, and can be used in cosmetic and pharmaceutical products within a prescribed dosage range without worry.
Example 8 antibacterial property test
Strain: escherichia coli (gram-negative bacteria), Staphylococcus aureus (gram-positive bacteria), Pseudomonas aeruginosa (gram-negative bacteria), Candida albicans (fungi)
Experimental groups are shown in table 2:
TABLE 2
Wherein the components of the culture medium for bacteria are as follows: 10g of peptone, 3g of beef extract, 5g of sodium chloride, 1000mL of distilled water and high-pressure steam sterilization at 121 ℃ for 15 min. The bacterial culture conditions were: the inoculum size was 2%, and the culture was carried out at 32 ℃ and 80rpm for 18 h. The culture medium for the fungi comprises the following components: yeast extract 10g, glucose 2g, sodium chloride 5g, distilled water 1000mL, using 6M HCl solution to adjust pH to about 5.5, and autoclaving at 121 deg.C for 15 min. The culture conditions of the fungi are as follows: the inoculum size was 2%, and the cells were incubated at 32 ℃ and 80rpm for 24 h.
Detection indexes are as follows: by measuring OD of bacterial liquid600And (4) calculating the bacteriostasis rate.
The experimental process comprises the following steps:
1. after the four bacteria preservation solutions are recovered, preparing the bacteria solution and counting, wherein the concentration of the bacteria solution is 106-7CFU/mL for standby;
2. replacing purified water in the compositions 1-6 with bacteria culture medium and fungus culture medium respectively, preparing bacteria/fungus culture medium containing the compositions, adjusting pH value, packaging and sterilizing; the culture medium of the control group is a bacteria culture medium or a fungus culture medium without the composition;
3. inoculating the bacterial liquid in the 1 into the control group and the experimental group according to the inoculation amount of 2%, and then performing shake culture at 32 ℃ and 80rpm for corresponding time;
4. measuring OD of bacteria/fungi culture solution in control group and experimental group with spectrophotometer600And subtracting the OD of the corresponding blank group medium600Finally, the bacteriostatic ratio (%) of the experimental group was calculated as (1-) × 100.
The inhibition rates of the compositions 1 to 6 against the above-mentioned four bacteria are shown in Table 3.
TABLE 3
As shown in Table 3, the bacteriostatic ratios of the compositions 1-6 prepared in the above examples 1-6 to Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans were all > 90% or more, indicating that the compositions provided by the present invention have good antibacterial effects.
Example 9 skin Barrier repair test
The skin barrier is mainly composed of the sebaceous membrane and the stratum corneum. The damaged sebum membrane can cause the immunity of the skin to be reduced, the water locking function to be weakened, the skin to become dry, pruritus, molting, red swelling and even pigmentation to become sensitive. The normal and intact stratum corneum can effectively prevent the invasion of external environment and the loss of water in vivo. Thus, the epidermal barrier is damaged, which results in increased sensitivity of the skin to external allergens and harmful stimuli, and pathogenic microorganisms more easily invade the skin through the stratum corneum, thereby deepening the degree of the damage of the skin barrier function or delaying the skin barrier repair. That is, the barrier function of the skin is not repaired in time, which can induce further infection and chronic inflammation.
Therefore, 2, 4-Dinitrochlorobenzene (DNCB) is used for inducing BALB/c mice to generate atopic dermatitis-like skin lesions, and an atopic dermatitis-like mouse model is established. The repair effect of compositions 1-6 on skin permeability barrier and anti-infective barrier was evaluated by measuring the amount of percutaneous water loss (TEWL) of compositions 1-6 in examples 1-6 after topical application to this mouse model with impaired skin barrier function.
Experimental animals: SPF-grade BALB/c mice, male and female halves, body weight 20 + -2 g.
Preparing a model:
1. after shaving the hair on the back and neck of the mouse with a shaver, the mouse was depilated, and the model was modeled one day after skin preparation.
2. The mice were randomly divided into 8 groups of 5 mice each, namely, normal control group, matrix group, experimental groups 1-6 (using the above compositions 1-6, respectively).
3. Sensitization at week 1: mice in the matrix and experimental groups were shaved with 1% DNCB 100. mu.l for 3 days/time, 2 times.
4. Week 2 challenge: mice in the matrix and experimental groups were shaved with 0.2% DNCB 100. mu.l for 3 days/time, 2 times. Preparing an atopic dermatitis-like mouse model.
The experimental process comprises the following steps: 24h after 2 weeks of challenge, the experimental groups were coated with 1-6100 μ l of a composition using purified water as a solvent in a modeling area, and the matrix group was coated with purified water 1 time a day for 14 days.
The detection method comprises the following steps: the TEWL level of the shaved back of the mice was measured 1 time every 2 days at room temperature of 20-25 ℃ and relative air humidity of 50% -60%. The Tewameter TM300 meter was placed in as vertical and full contact with the skin surface of the site to be tested as possible, and each site was measured three times and the average was taken.
The transdermal water loss (TEWL) is an important indicator that objectively reflects the skin barrier function. Normal skin has water retention capacity, and when the skin barrier is damaged, the water retention capacity is reduced, water evaporation is increased, and the transdermal water dispersion amount of the skin is increased, so that the recovery degree of the skin barrier can be judged by detecting the change of the TEWL value. Setting the skin barrier repair rate of a normal control group as 100%, setting the skin barrier repair rate of 0h after modeling as 0%, and calculating the skin barrier repair rate of a substrate group and an experimental group according to the following formula: skin barrier repair rate (%) (1-) × 100.
The results of the effect of each composition on the skin barrier repair rate as measured by the normal control group, the vehicle group, and the experimental groups 1 to 6 are shown in fig. 1.
The results shown in fig. 1 indicate that the compositions 1-6 prepared in examples 1-6 all were able to promote the repair of the damaged skin barrier after the skin barrier was damaged, and the skin barrier repair rate was higher than that of the matrix group. Wherein the skin barrier repair rate is higher for the spread compositions 4 and 1 than for the other compositions. The skin barrier repair rates of the spread compositions 2, 3, 5 and 6 were comparable. The above results demonstrate the potential utility of the compositions provided by the present invention in the treatment of skin disorders associated with an impaired skin barrier.
EXAMPLE 10 cream test
TABLE 4 cream formulations containing the topical compositions of the present invention
The preparation method comprises the following steps: heating oil phase components such as vitamin E, stearic acid, cetyl alcohol, and lanolin for melting, and maintaining the temperature at 70-80 deg.C to form oil phase liquid. Heating water phase components such as tetrahydropyrimidine, sodium hyaluronate, surfactant, epsilon-polylysine, vitamin B5, natural plant components, propylene glycol, triethanolamine and distilled water to 70-80 deg.C to form water phase liquid. Slowly adding the oil phase solution into the water phase solution, and continuously stirring to shape.
Comparative example 1 glucocorticoid based cream
TABLE 5 glucocorticoid cream formulations
| Name of ingredient | Component weight (g) |
| Dexamethasone acetate | 0.75 |
| |
100 |
| Cetyl alcohol | 45 |
| |
10 |
| Propylene glycol | 150 |
| Sodium dodecyl sulfate | 5 |
| Triethanolamine | 7 |
| Distilled water | Is supplemented to 1000 |
The preparation method comprises the following steps: heating and melting dexamethasone acetate, stearic acid, cetyl alcohol and lanolin as oil phase components, and maintaining the temperature at 70-80 deg.C to form oil phase liquid. Heating water phase components including propylene glycol, sodium dodecyl sulfate, triethanolamine and distilled water to 70-80 deg.C to form water phase liquid. Slowly adding the oil phase solution into the water phase solution, and continuously stirring to shape.
Example 11 clinical trial evaluation
30 skin-red, itchy, partially dry and flaccid or partially papular volunteers were selected and randomly divided into 3 groups of 10 persons each, 1 group using the cream of example 10 of the present invention and 1 group using the cream of comparative example 1 of the present invention, and the two groups of subjects were applied twice a day, once in the morning and evening, after washing and drying the skin. The other 1 group was blank and no product was applied.
The results of the trial are shown in Table 6:
from the above clinical observation results, it can be seen that after one week of application of the cream of example 10 of the present invention, the allergic symptoms are significantly alleviated and almost all return to normal levels, indicating that the composition of the present invention has significant anti-inflammatory and anti-allergic effects and can well relieve the allergic symptoms of the skin. While after one week of application of the cream of comparative example 1, the skin allergy symptoms were only partially relieved, and the skin condition was not restored to normal until three weeks of application. The composition of the invention has better and faster effect than the composition of the invention in the comparison ratio 1, which shows that the external composition for preventing, relieving or treating allergy has quick and obvious effect on allergic skin and has repairing effect on damaged cells of the allergic skin.
Claims (10)
1. A composition for external use for preventing, alleviating or treating skin allergy comprises 0.1-10% by mass of tetrahydropyrimidine or a derivative thereof, 0.1-20% by mass of hyaluronic acid or a derivative thereof, 0.1-5% by mass of a biosurfactant, and 0.01-0.1% by mass of epsilon-polylysine, with the balance being water or other base materials.
2. The composition for external use for preventing, alleviating or treating skin allergy according to claim 1, wherein the derivative of tetrahydropyrimidine is hydroxytetrahydropyrimidine.
3. The composition for external use for preventing, alleviating or treating skin allergy according to claim 1 or 2, wherein the content of the tetrahydropyrimidine or derivative thereof is 2% to 5%.
4. The composition for external use for preventing, alleviating or treating skin allergy according to claim 1, wherein the molecular weight of hyaluronic acid or its derivative is 1 x 103Da-4×105Da。
5. The composition for external use according to claim 4, wherein the hyaluronic acid or the derivative thereof is at least one selected from hyaluronic acid or a salt thereof, and a hyaluronic acid derivative obtained by etherification, esterification, amidation, acetalization, and acetylation of a hydroxyl group and a carboxyl group of hyaluronic acid.
6. The composition for external use for preventing, alleviating or treating skin allergy according to claim 1, 4 or 5, wherein the content of hyaluronic acid or a derivative thereof is 5% to 10%.
7. The topical composition for preventing, alleviating or treating skin allergy according to claim 1, characterized in that the biosurfactant comprises glycolipids and/or lipopeptides.
8. The external composition for preventing, alleviating or treating skin allergy according to claim 1, wherein the biosurfactant is at least one selected from the group consisting of sophorolipids, sucrose lipids, rhamnolipids, trehalose glycolipids, mannosylerythritol lipids, surfactin, iturin, muskonein, and lichenin.
9. The composition for external use for preventing, alleviating or treating skin allergy according to claim 1, 7 or 8, wherein the content of the biosurfactant is 1% to 2%.
10. The composition for external use for preventing, alleviating or treating skin allergy according to claim 1, wherein the content of epsilon-polylysine is 0.05%.
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| WO2021129617A3 (en) * | 2019-12-26 | 2021-10-07 | 华熙生物科技股份有限公司 | Topical composition for preventing, alleviating, or treating skin allergies, and use therefor |
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| WO2021129617A3 (en) * | 2019-12-26 | 2021-10-07 | 华熙生物科技股份有限公司 | Topical composition for preventing, alleviating, or treating skin allergies, and use therefor |
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| CN111840307A (en) * | 2020-08-18 | 2020-10-30 | 山东华熙海御生物医药有限公司 | Composition with effects of easing pain, relieving itching and eliminating eczema |
| CN111840307B (en) * | 2020-08-18 | 2023-09-12 | 华熙生物科技股份有限公司 | Composition with effects of easing pain, relieving itching and removing dampness and rash |
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| CN115414262A (en) * | 2022-07-19 | 2022-12-02 | 江苏诺兴生物科技有限公司 | Epsilon-polylysine Pickering emulsion and preparation method and application thereof |
| CN115414262B (en) * | 2022-07-19 | 2023-09-22 | 江苏诺兴生物科技有限公司 | Epsilon-polylysine Pickering emulsion and preparation method and application thereof |
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| WO2021129617A2 (en) | 2021-07-01 |
| WO2021129617A3 (en) | 2021-10-07 |
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