A composition containing soy isoflavones, its preparation method and application
By leveraging the synergistic effect of liposomes with a bimolecular membrane structure and transdermal absorption enhancers, the problem of low transdermal absorption efficiency of soy isoflavone cosmetics is solved, achieving synergistic effects of multiple skin care benefits and gentleness, making it suitable for sensitive and acne-prone skin.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- TIANJIN TIANYAO PHARM CO LTD
- Filing Date
- 2026-03-24
- Publication Date
- 2026-06-02
AI Technical Summary
Existing soy isoflavone cosmetics have low transdermal absorption efficiency, making it impossible to achieve the synergistic effect of multiple functions such as oil control and acne removal, moisturizing and repairing, brightening and anti-aging. In addition, they are highly irritating to the skin and cannot meet the skin care needs of sensitive and acne-prone skin.
This product uses a composition containing soy isoflavones. Through the synergistic effect of liposomes with bilayer membrane structure and transdermal absorption enhancers, the transdermal rate and depth of soy isoflavones are enhanced. At the same time, emulsifiers and moisturizers are added to improve the stability and gentleness of the product, making it suitable for sensitive skin.
It significantly enhances the transdermal absorption rate and depth of soy isoflavones, achieving multiple benefits such as oil control and acne treatment, moisturizing and repairing, brightening and anti-aging, while reducing skin irritation, making it suitable for the skincare needs of sensitive and acne-prone skin.
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Abstract
Description
Technical Field
[0001] This invention relates to the technical field of cosmetics, and in particular to a composition containing soy isoflavones, its preparation method, and its application. Background Technology
[0002] Modern skin often faces multiple challenges, such as acne during puberty and adulthood. Post-pubertal acne in women is characterized by delayed onset, stubbornness, and worsening before menstruation. Lack of sleep and stress can lead to dull skin, collagen loss causing fine lines and wrinkles, and environmental irritants can weaken the skin barrier. These problems not only affect skin health but can also lower self-confidence. Traditional skincare products often focus on single effects, using irritating ingredients for acne or neglecting skin type adaptability for anti-aging, failing to meet the modern woman's demand for "gentle repair and multi-functional" skincare. Some acne-prone individuals have sensitive skin. Ordinary moisturizing and brightening products often remain on the skin's surface, unable to penetrate deeper to address the root cause of the problem, and lack the ability to regulate internal factors such as endocrine fluctuations and inflammatory responses. Anti-early aging products often rely on chemically synthesized ingredients, which can cause allergies and redness in some users, exhibiting poor compatibility. These shortcomings make it difficult for most products to achieve a synergistic effect of "oil control and acne treatment + moisturizing and repair + brightening and anti-aging," resulting in a high recurrence rate of skin problems.
[0003] Soy isoflavones, as natural polyphenolic compounds extracted from soybeans, have become an ideal choice for a new generation of multifunctional skin care ingredients due to their unique plant-derived activity, antioxidant properties, and multiple skin care effects. Their core skin care mechanism covers multiple dimensions: (1) By regulating skin receptors, it helps improve the sebum secretion rhythm and reduces sebum secretion from the root; at the same time, it inhibits the expression of pro-inflammatory factors such as TNF-α and IL-6, reduces the inflammatory response of hair follicle sebaceous glands, precisely improves acne problems, is gentle and burden-free, and is especially suitable for women's post-adolescent acne care. (2) It directly removes free radicals, activates antioxidant enzyme systems such as SOD, and delays skin oxidation and aging; at the same time, it can stimulate skin estrogen receptors, promote the synthesis of collagen and elastin fibers, improve fine lines and wrinkles, and enhance skin firmness; in addition, it can inhibit tyrosinase activity, reduce melanin production, even out skin tone, and improve dullness and yellowing. (3) Its natural polyphenol structure has good biocompatibility, which can soothe skin redness and sensitivity caused by external stimuli, while promoting the synthesis of lipids in the stratum corneum, enhancing the skin's water-locking ability, improving dryness and peeling, and keeping the skin soft, delicate and healthy.
[0004] Ordinary soy isoflavone cosmetics have poor solubility and transdermal absorption. However, by forming them into liposomes, the poorly soluble soy isoflavones can be encapsulated in a liposome bilayer membrane structure. This facilitates the penetration and fusion of active ingredients into the skin's base layer, enhancing the efficacy of oil control, acne treatment, and antioxidant effects. It also reduces the direct contact of soy isoflavones with the skin, making it more suitable for sensitive skin and other special groups. Adding a penetration enhancer to the system can further amplify the delivery advantages of liposomes, synergistically constructing a dual transdermal pathway with the liposomes. This not only alters the stratum corneum structure to open channels but also integrates into the liposome membrane to improve its fusion efficiency with the stratum corneum, significantly accelerating the rate and depth of soy isoflavone transdermal absorption.
[0005] Ordinary soy isoflavone cosmetics often exhibit poor synergy, focusing primarily on single effects and failing to simultaneously achieve a comprehensive range of benefits, including oil control and acne treatment, moisturizing and repairing, and brightening and anti-aging. This makes them inadequate for addressing multiple skin concerns, leading to a high recurrence rate of skin problems. Furthermore, ordinary cosmetics often lack ingredient compatibility and gentleness, frequently using irritating ingredients for acne treatments and relying heavily on chemically synthesized components for combating early skin aging, which can easily trigger allergies and redness in sensitive skin. More importantly, ordinary soy isoflavone cosmetics have low transdermal absorption efficiency, preventing active ingredients from penetrating deep into the skin, directly impacting their skincare efficacy and resulting in limited results and poor stability.
[0006] In view of this, in order to overcome the above-mentioned defects of the prior art, improve the transdermal utilization rate of soy isoflavones and the gentleness of the product, and achieve a multi-effect synergistic, safe and comfortable skin care experience, this invention is proposed. Summary of the Invention
[0007] The purpose of this invention is to provide a composition containing soy isoflavones, its preparation method, and its application, so as to at least solve how to improve the transdermal absorption efficiency of soy isoflavones in cosmetics and achieve the synergistic effect of multiple functions such as oil control and acne removal, moisturizing and repairing, brightening and anti-aging; at the same time, to solve how to reduce skin irritation and improve the safety and effectiveness of the product in people with sensitive skin and acne-prone skin.
[0008] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted: In a first aspect, the present invention provides a composition containing soy isoflavones, the composition comprising soy isoflavones, an oil phase matrix, liposome excipients, a transdermal absorption enhancer, a moisturizer, an emulsifier, an antioxidant, a chelating agent, and a preservative. The liposome excipients include a first liposome excipient as a membrane skeleton material and a second liposome excipient as a membrane regulator material.
[0009] Furthermore, the oil phase matrix comprises lipophilic polymers and / or small molecule oils; The fat-soluble polymer is selected from any one or a combination of at least two of polysiloxanes, fatty acid polyesters, and polyolefins; the small molecule oil is selected from any one or a combination of at least two of vegetable oils, animal oils, mineral oils, and synthetic oils.
[0010] Further, the oil phase matrix is any one or a combination of at least two of the following: dimethyl silicone oil, polyglycerol fatty acid ester, polybutene, olive oil, castor oil, lanolin, beeswax, petrolatum, liquid paraffin, white oil, cetearyl alcohol, cetyl alcohol, stearic acid, isopropyl palmitate, caprylic / capric triglyceride, and isopropyl myristate.
[0011] Furthermore, the oil phase matrix is a mixture of stearic acid and petrolatum.
[0012] Furthermore, the mass ratio of stearic acid to petrolatum is (1~29):(1~20).
[0013] Further, the first liposome excipient includes any one or a combination of at least two of soybean lecithin, egg yolk lecithin, hydrogenated soybean lecithin, dipalmitoylphosphatidylcholine, distearate phosphatidylcholine, dioleoylphosphatidylethanolamine, phosphatidylcholine, phosphatidylglycerol, and medium-chain triglycerides, preferably soybean lecithin.
[0014] Furthermore, the second liposome excipient comprises any one or a combination of at least two of cholesterol, sitosterol, stigmasterol, cholesterol succinate, vitamin E, stearylamine, octadecylamine, and behenicol glyceride, preferably cholesterol.
[0015] Furthermore, the liposome excipient is a mixture of soybean lecithin and cholesterol.
[0016] Furthermore, the mass ratio of soybean phospholipids to cholesterol is (1~10):1, preferably (1.5~8):1.
[0017] Furthermore, the transdermal absorption enhancer includes any one or a combination of at least two of isopropyl palmitate, menthol, borneol, oleic acid, and laurocapram, preferably isopropyl palmitate.
[0018] Furthermore, the moisturizer includes any one or a combination of at least two of polyol moisturizers, natural moisturizing factors, high molecular weight biochemical moisturizers, and amino acid moisturizers, preferably any one or a combination of at least two of astragalus polysaccharide, sodium hyaluronate, dipotassium glycyrrhizate, glycerin, polyethylene glycol, sorbitol, maltitol, aloe vera gel, sodium lactate, and squalane, and more preferably glycerin.
[0019] Further, the emulsifier includes any one or a combination of at least two of alkyl glycoside emulsifiers, polyol ester emulsifiers, copan emulsifiers, Tween emulsifiers, phosphate ester emulsifiers, fatty alcohol polyether emulsifiers, polyglycerol emulsifiers, and polymeric compound emulsifiers, preferably any one or a combination of at least two of stearyl alcohol polyoxyethylene ether-721, sucrose ester, polysorbate 80, polysorbate 60, Span 80, and glyceryl monostearate, more preferably polysorbate 80.
[0020] Furthermore, the antioxidant includes any one or a combination of at least two of sodium bisulfite, vitamin E, lauryl gallate, propyl gallate, ferulic acid, butylated hydroxytoluene, magnesium ascorbate phosphate, and sodium ascorbate phosphate, preferably vitamin E.
[0021] Furthermore, the chelating agent includes any one or a combination of at least two of gluconate-δ-lactone, sodium citrate, and disodium edetate, preferably disodium edetate.
[0022] Furthermore, the composition containing soy isoflavones also includes a preservative.
[0023] Furthermore, the preservative includes any one or a combination of at least two of the following: propylparaben, ethylparaben, methylparaben, benzalkonium bromide, benzalkonium chloride, and parabens, preferably propylparaben.
[0024] Furthermore, the composition containing soy isoflavones also includes a pH adjuster.
[0025] Furthermore, the pH adjuster includes any one or a combination of at least two of citric acid, malic acid, lactic acid, phosphoric acid, triethanolamine, and hydrochloric acid, preferably triethanolamine and / or citric acid.
[0026] Further, the composition containing soy isoflavones comprises, by weight parts: 0.1-10 parts soy isoflavones, 3-30 parts oil phase matrix, 1-20 parts liposome excipients, 0.05-5 parts transdermal absorption enhancer, 1-20 parts humectant, 0.2-6 parts emulsifier, 0.01-2 parts antioxidant, 0.01-0.2 parts chelating agent, and 0.01-0.6 parts preservative.
[0027] Further, the composition of soy isoflavones comprises, by weight parts: 0.5-4 parts soy isoflavones, 8-25 parts oil phase matrix, 3-15 parts liposome excipients, 1-4 parts transdermal absorption promoter, 2-8 parts humectant, 1-3 parts emulsifier, 0.05-0.5 parts antioxidant, 0.02-0.1 parts chelating agent, and 0.05-0.2 parts preservative.
[0028] Furthermore, the pH of the soy isoflavone composition is 4.0 to 8.0, preferably 5.5 to 7.5.
[0029] In a second aspect, the present invention provides a method for preparing the composition containing soy isoflavones as described in the first aspect, comprising: (1) The first liposome excipient, the second liposome excipient, soy isoflavones and the first solvent are mixed and the first solvent is removed by evaporation to obtain a lipid film; the moisturizer, part of the emulsifier and the second solvent are mixed to obtain a mixture A; the lipid film and the mixture A are mixed to obtain a primary emulsion; the primary emulsion is subjected to high pressure homogenization to obtain nano-sized liposomes; (2) Mix the oil phase matrix, antioxidant and transdermal absorption enhancer to obtain the oil phase; mix the remaining emulsifier, chelating agent, preservative and second solvent to obtain mixture B; mix the oil phase and mixture B to obtain the cream matrix; (3) The nano-sized liposomes and the cream matrix are mixed and subjected to shearing and homogenization to obtain the composition containing soy isoflavones.
[0030] Furthermore, the first solvent includes any one or a combination of at least two of ethanol, propylene glycol, glycerol, and water, preferably an aqueous solution of ethanol.
[0031] Furthermore, the percentage content of the ethanol aqueous solution is 70-80 vol.
[0032] Furthermore, the second solvent includes water.
[0033] Further, in step (1), the temperature at which the first liposome excipient, the second liposome excipient, soy isoflavones and the first solvent are mixed is 45~55℃.
[0034] Further, in step (1), the evaporation temperature is 45~55℃ and the evaporation pressure is -0.10~-0.05 MPa.
[0035] Furthermore, in step (1), the temperature at which the lipid film and mixture A are mixed is 38~48℃.
[0036] Further, in step (1), the pressure of the high-pressure homogenization process is 80~150 MPa, and the number of high-pressure homogenization processes is 3~8.
[0037] Further, in step (1), the emulsifier accounts for 15-70% of the total mass of the emulsifier, preferably 30-60%.
[0038] Furthermore, in step (2), the temperature at which the oil phase matrix, antioxidant, and transdermal absorption promoter are mixed is 65~75℃.
[0039] Furthermore, in step (2), the temperature at which the remaining emulsifier, chelating agent, preservative, and second solvent are mixed is 65~75°C.
[0040] Furthermore, in step (2), the temperature at which the oil phase and the mixture B are mixed is 65~75℃.
[0041] Furthermore, in step (3), the mixing temperature of the nano-sized liposomes and the cream matrix is 40~50℃.
[0042] Further, in step (3), the rotation speed of the shearing homogenization process is 10,000 to 19,000 rpm, and the time of the shearing homogenization process is 10 to 50 min.
[0043] Furthermore, in step (3), the shearing and homogenization process further includes the following steps: The treated liquid was cooled to below 40°C, and the pH of the liquid was adjusted to 5.5-7.5 using a pH adjuster. Water was then added to obtain the composition containing soy isoflavones.
[0044] Thirdly, the present invention provides the use of the composition containing soy isoflavones as described in the first aspect in the preparation of cosmetics.
[0045] Compared with the prior art, the present invention has the following beneficial effects: The composition containing soy isoflavones of the present invention has a bilayer membrane structure, which can specifically address the technical defects of ordinary cosmetics. The specific mechanism and effects are as follows: (1) The liposomes of the composition containing soy isoflavones described in this invention have a similar lipid structure to the stratum corneum of the skin. They can easily penetrate the stratum corneum through permeation and fusion, and promote the soy isoflavones into the skin base, so that their core effects such as anti-inflammatory and antioxidant can be fully exerted, and significantly improve the effects of oil control and acne removal, fine line improvement and skin brightening. (2) The use of a bimolecular membrane to encapsulate the soy isoflavones in the composition of the present invention can reduce the direct contact between soy isoflavones and the skin, making it more suitable for special groups such as sensitive skin and acne-prone skin, avoiding discomfort such as redness and dryness, and achieving the need for gentle repair. (3) The composition containing soy isoflavones described in this invention can further amplify the delivery advantage of liposomes by adding a permeation promoter to the system, and synergistically construct a dual transdermal pathway with liposomes. This not only changes the structure of the stratum corneum to open up channels, but also integrates into the liposome membrane to improve its fusion efficiency with the stratum corneum, significantly accelerating the transdermal rate and depth of soy isoflavones. (4) The composition containing soy isoflavones described in this invention adds an emulsifier to the system. Based on the dual requirements of "liposome stabilization" and "cream emulsification", the emulsifier is added in stages as an "auxiliary emulsifier" for liposomes. It can reduce the interfacial tension between the lipid membrane and the aqueous phase, promote the dispersion of the lipid membrane into small-diameter liposomes during hydration, enhance the stability of liposomes, reduce aggregation, and synergistically improve the nano-sizing effect with high-pressure homogenization. Detailed Implementation
[0046] Unless otherwise defined herein, the scientific and technical terms used in conjunction with this invention shall have the meanings commonly understood by one of ordinary skill in the art. The meaning and scope of terms shall be clear; however, in any case of potential ambiguity, the definitions provided herein shall prevail over any dictionary or foreign definitions. In this application, unless otherwise stated, the use of "or" means "and / or". Furthermore, the use of the term "comprising" and other forms is non-limiting.
[0047] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0048] In a first aspect, the present invention provides a composition containing soy isoflavones, the composition comprising soy isoflavones, an oil phase matrix, liposome excipients, a transdermal absorption enhancer, a moisturizer, an emulsifier, an antioxidant, and a chelating agent; The liposome excipients include a first liposome excipient as a membrane skeleton material and a second liposome excipient as a membrane regulator material.
[0049] It should be noted that the composition containing soy isoflavones of the present invention has a bimolecular membrane structure, which can specifically address the technical defects of ordinary cosmetics. The liposomes are composed of a first liposome excipient forming a bimolecular membrane framework. The first liposome excipient is mainly a phospholipid, whose hydrophilic head and hydrophobic tail self-assemble to form a closed vesicle structure. This effectively encapsulates poorly soluble and easily oxidized soy isoflavones within the membrane or the aqueous phase, preventing their degradation in the formulation and significantly improving chemical stability. This bimolecular membrane structure mimics the lipid arrangement of the stratum corneum of the skin, exhibiting good biocompatibility and... The fusion property promotes the interaction between vesicles and the stratum corneum of the skin through passive diffusion and membrane fusion, enabling targeted delivery of soy isoflavones to the deep epidermis and appendages, significantly increasing their intradermal retention in the local skin, thereby enhancing their oil-controlling, anti-inflammatory, and antioxidant effects. At the same time, the second liposome excipient is embedded in the bilayer membrane. The second liposome excipient is mainly composed of sterol lipids and / or long-chain aliphatic lipids, which can regulate the fluidity and mechanical strength of the membrane, increase membrane stability at low concentrations, prevent premature rupture of liposomes, and moderately release the contents under the stimulation of body temperature or skin microenvironment to achieve a sustained-release effect.
[0050] Furthermore, this bimolecular membrane structure effectively isolates soy isoflavones from direct contact with the skin surface, reducing potential irritation and making it particularly suitable for sensitive and acne-prone skin. Simultaneously, it exhibits a synergistic effect with transdermal absorption enhancers—the enhancers temporarily disrupt the lipid arrangement of the stratum corneum, widening intercellular spaces, while liposomes utilize this channel to penetrate more efficiently and fuse with the disordered lipid domains, forming a "dual-pathway" delivery mechanism that further enhances transdermal rate and depth. In summary, the liposome system based on the bimolecular membrane structure not only solves the problems of poor transdermal penetration and low stability of soy isoflavones but also achieves a breakthrough in multi-effect synergistic, gentle, and long-lasting skincare technology.
[0051] As an optional implementation, the oil phase matrix includes fat-soluble polymers and / or small molecule oils; The fat-soluble polymer is selected from any one or a combination of at least two of polysiloxanes, fatty acid polyesters, and polyolefins; the small molecule oil is selected from any one or a combination of at least two of vegetable oils, animal oils, mineral oils, and synthetic oils.
[0052] As an optional implementation, the oil phase matrix is any one or a combination of at least two of the following: dimethyl silicone oil, polyglycerol fatty acid ester, polybutene, olive oil, castor oil, lanolin, beeswax, petrolatum, liquid paraffin, white oil, cetearyl alcohol, cetyl alcohol, stearic acid, isopropyl palmitate, caprylic / capric triglyceride, and isopropyl myristate.
[0053] In a preferred embodiment, the oil phase matrix is a mixture of stearic acid and petrolatum.
[0054] It should be noted that the combination of stearic acid and petrolatum in this invention, used as an oil phase matrix, can synergistically enhance the stability and skin feel of the cream. Stearic acid has good emulsification stability and film-forming properties, which can improve the density of the cream structure; petrolatum has strong occlusive properties, which can effectively lock in water, moisturize and repair the skin barrier; the two have good compatibility and are not easily oxidized and deteriorated, which helps to maintain the uniformity and long-term storage stability of the cream, while giving the product a moderate melting point and spreadability. After application, it forms a breathable protective film, improves dryness and flaking, and is suitable for sensitive and acne-prone skin.
[0055] As an optional implementation, the mass ratio of stearic acid to petrolatum is (1~29):(1~20); Among them, "1~29" can be, for example, 1, 2, 4, 5, 6, 8, 10, 12, 14, 15, 16, 18, 20, 22, 24, 25, 26, 28, 29, etc.; Among them, "1~20" can be, for example, 1, 2, 4, 5, 6, 8, 10, 12, 14, 15, 16, 18, 20, etc.
[0056] As an optional implementation, the first liposome excipient includes any one or a combination of at least two of the following: soybean lecithin, egg yolk lecithin, hydrogenated soybean lecithin, dipalmitoyl phosphatidylcholine, distearate phosphatidylcholine, dioleoyl phosphatidylethanolamine, phosphatidylcholine, phosphatidylglycerol, and medium-chain triglycerides.
[0057] In a preferred embodiment, the first liposome excipient is soybean lecithin.
[0058] As an optional implementation, the second liposome excipient includes any one or a combination of at least two of cholesterol, sitosterol, stigmasterol, cholesterol succinate, vitamin E, stearylamine, octadecylamine, and behenicol glyceryl ester.
[0059] In a preferred embodiment, the second liposome excipient is cholesterol.
[0060] In a preferred embodiment, the liposome excipient is a mixture of soybean lecithin and cholesterol.
[0061] It should be noted that soybean lecithin, as a natural amphoteric lipid, can precisely encapsulate hydrophobic soy isoflavones with its hydrophilic head and hydrophobic tail. At the same time, its molecular structure is highly similar to that of lipids in the stratum corneum of the skin, facilitating its penetration of the skin barrier. Cholesterol can be embedded in the bilayer membrane formed by soybean lecithin, regulating the fluidity and stability of the membrane and preventing the liposomes from fusing or breaking during preparation and storage, while also improving the fusion efficiency of liposomes with the stratum corneum of the skin. The synergistic effect of the two results in liposomes with more uniform particle size (nanoscale) and better encapsulation efficiency and stability compared to other liposome excipient combinations, significantly enhancing the persistence of the active ingredients.
[0062] As an optional implementation, the mass ratio of soybean phospholipids to cholesterol is (1~10):1, for example, it can be 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, etc.
[0063] In a preferred embodiment, the mass ratio of soybean phospholipids to cholesterol is (1.5~8):1.
[0064] As an optional implementation, the transdermal absorption enhancer includes any one or a combination of at least two of isopropyl palmitate, menthol, borneol, oleic acid, and lauryl acetone.
[0065] As an optional implementation, the transdermal absorption enhancer is isopropyl palmitate.
[0066] It should be noted that isopropyl palmitate has good lipid solubility and can be incorporated into the liposome bilayer membrane, improving membrane fluidity and permeability, forming a temporary transdermal channel, and further enhancing the transdermal efficiency of liposomes. This is something that volatile promoters such as menthol and borneol cannot achieve (as they easily lead to liposome membrane rupture). Compared with oleic acid, isopropyl palmitate has lower irritation and stronger stability, and will not affect product efficacy due to oxidative deterioration, making it significantly superior to other transdermal promoter combinations.
[0067] As an optional implementation, the moisturizer includes any one or a combination of at least two of the following: polyol moisturizers, natural moisturizing factors, polymeric biochemical moisturizers, and amino acid moisturizers.
[0068] As an optional implementation, the moisturizer is any one or a combination of at least two of the following: Astragalus polysaccharide, sodium hyaluronate, dipotassium glycyrrhizate, glycerin, polyethylene glycol, sorbitol, maltitol, aloe vera gel, sodium lactate, and squalane.
[0069] In a preferred embodiment, the moisturizer is glycerin.
[0070] It should be noted that glycerin has excellent hygroscopic and moisturizing properties, which can absorb moisture from the environment to replenish skin moisture. At the same time, it can promote the synthesis of lipids in the stratum corneum and enhance the skin barrier function. It has excellent compatibility with the liposomes, emulsifiers and other components in the composition of this invention, and will not affect the structural stability of the liposomes. It can also improve the spreadability of the cream. Compared with high molecular weight moisturizers such as sodium hyaluronate, glycerin has stronger permeability and can work synergistically with liposomes to penetrate deep into the skin to exert a moisturizing effect. Compared with polyols such as sorbitol, glycerin has better moisturizing long-lasting effect.
[0071] As an optional implementation, the emulsifier includes any one or a combination of at least two of the following: alkyl glycoside emulsifiers, polyol ester emulsifiers, copan emulsifiers, Tween emulsifiers, phosphate ester emulsifiers, fatty alcohol polyether emulsifiers, polyglycerol emulsifiers, and polymeric compound emulsifiers.
[0072] As an optional implementation, the emulsifier is any one or a combination of at least two of stearyl alcohol polyoxyethylene ether-721, sucrose ester, polysorbate 80, polysorbate 60, Span 80, and glyceryl monostearate.
[0073] In a preferred embodiment, the emulsifier is polysorbate 80.
[0074] It should be noted that polysorbate 80 has excellent emulsifying ability, and its HLB value is highly compatible with the oil and aqueous phase components of the composition of this invention. Compared with emulsifiers such as Span 80, it has higher emulsification efficiency and requires less addition. Furthermore, it has good compatibility with liposomes, does not damage the liposome membrane structure, and can help improve the uniformity of liposome dispersion in the cream. Compared with emulsifiers such as sucrose esters, polysorbate 80 has stronger stability over a wide pH range (4.0~8.0), ensuring the emulsification stability of the product under different storage conditions—an advantage that other emulsifiers cannot achieve. In addition, since liposomes formed from simple soybean phospholipids / cholesterol are prone to aggregation due to hydrophobic interactions, adding a small amount of nonionic polysorbate 80 (which has good compatibility with phospholipids) can improve dispersibility, making it particularly suitable for stability when subsequently mixed with the cream matrix.
[0075] As an optional implementation, the antioxidant includes any one or a combination of at least two of sodium bisulfite, vitamin E, lauryl gallate, propyl gallate, ferulic acid, butylated hydroxytoluene, magnesium ascorbate phosphate, and sodium ascorbate phosphate.
[0076] As an optional implementation, the antioxidant is vitamin E.
[0077] It should be noted that vitamin E has strong antioxidant activity, delaying the oxidative deterioration of soy isoflavones. It also has skin-care benefits, moisturizing the skin and enhancing its barrier function. As a fat-soluble component, it can be incorporated into the oil phase and liposome membranes. Compared to water-soluble antioxidants (such as sodium bisulfite), it disperses more evenly in the cream system of this invention, resulting in a longer-lasting antioxidant effect. Furthermore, the synergistic effect of vitamin E and soy isoflavones further enhances the product's anti-aging effect. Compared to synthetic antioxidants such as butylated hydroxytoluene (BHT), vitamin E has higher biocompatibility and lower irritation.
[0078] As an optional implementation, the chelating agent includes any one or a combination of at least two of gluconate-δ-lactone, sodium citrate, and disodium edetate.
[0079] In a preferred embodiment, the chelating agent is disodium edetate.
[0080] It should be noted that disodium edetate can effectively chelate metal ions in water, preventing the oxidative deterioration of active ingredients and oils in its catalytic composition and improving the storage stability of the product. Compared with chelating agents such as sodium citrate and gluconate-δ-lactone, it has a stronger chelating ability and requires less addition.
[0081] As an optional implementation, the preservative includes any one or a combination of at least two of the following: propylparaben, ethylparaben, methylparaben, benzalkonium bromide, benzalkonium chloride, and parabens.
[0082] In a preferred embodiment, the preservative is propylparaben.
[0083] It should be noted that propylparaben belongs to the paraben class of preservatives, which has broad-spectrum antibacterial activity, low irritation, high safety, and requires less addition. Compared with quaternary ammonium salt preservatives, it is less irritating to the skin and is more suitable for use in cosmetics for long-term use.
[0084] As an optional embodiment, the composition containing soy isoflavones further includes a pH adjuster.
[0085] As an optional implementation, the pH adjuster includes any one or a combination of at least two of citric acid, malic acid, lactic acid, phosphoric acid, triethanolamine, and hydrochloric acid.
[0086] In a preferred embodiment, the pH adjuster is triethanolamine and / or citric acid.
[0087] It should be noted that triethanolamine and citric acid can form a buffer system, precisely adjusting the pH of the composition to 5.5-7.5 (close to the physiological pH of the skin), avoiding pH fluctuations that could affect product stability and safety. Compared to strong acid regulators such as hydrochloric acid, citric acid is gentler and will not irritate the skin. Compared to regulators such as phosphoric acid, citric acid has better compatibility with other components in the composition. Triethanolamine can also assist in emulsification, improving the smoothness of the cream. The synergistic effect of the two can keep the pH of the composition stable during storage. Compared to regulators such as malic acid, the adjustment precision is higher, and no odor is introduced, ensuring a better user experience.
[0088] As an optional embodiment, the composition containing soy isoflavones comprises, by weight parts: 0.1-10 parts of soy isoflavones, 3-30 parts of oil phase matrix, 1-20 parts of liposome excipients, 0.05-5 parts of transdermal absorption promoter, 1-20 parts of moisturizer, 0.2-6 parts of emulsifier, 0.01-2 parts of antioxidant, 0.01-0.2 parts of chelating agent, and 0.01-0.6 parts of preservative.
[0089] As an optional embodiment, the content of soy isoflavones in the composition is 0.1 to 10 parts, for example, it can be 0.1 parts, 0.5 parts, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, etc.
[0090] As an optional embodiment, the content of the oil phase matrix in the composition containing soy isoflavones is 3 to 30 parts, for example, it can be 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, etc. Quantities include: 15.5 portions, 16 portions, 16.5 portions, 17 portions, 17.5 portions, 18 portions, 18.5 portions, 19 portions, 19.5 portions, 20 portions, 20.5 portions, 21 portions, 21.5 portions, 22 portions, 22.5 portions, 23 portions, 23.5 portions, 24 portions, 24.5 portions, 25 portions, 25.5 portions, 26 portions, 26.5 portions, 27 portions, 27.5 portions, 28 portions, 28.5 portions, 29 portions, 29.5 portions, 30 portions, etc.
[0091] As an optional embodiment, the content of liposome excipient in the composition containing soy isoflavones is 1 to 20 parts, for example, it can be 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, 15.5 parts, 16 parts, 16.5 parts, 17 parts, 17.5 parts, 18 parts, 18.5 parts, 19 parts, 19.5 parts, 20 parts, etc.
[0092] As an optional embodiment, the content of the transdermal absorption promoter in the composition containing soy isoflavones is 0.05 to 5 parts, for example, 0.05 parts, 0.1 parts, 0.5 parts, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, etc.
[0093] As an optional embodiment, the content of the humectant in the composition containing soy isoflavones is 1 to 20 parts, for example, it can be 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, 15.5 parts, 16 parts, 16.5 parts, 17 parts, 17.5 parts, 18 parts, 18.5 parts, 19 parts, 19.5 parts, 20 parts, etc.
[0094] As an optional embodiment, the content of emulsifier in the composition containing soy isoflavones is 0.2 to 6 parts, for example, it can be 0.2 parts, 0.4 parts, 0.6 parts, 0.8 parts, 1 part, 1.2 parts, 1.4 parts, 1.6 parts, 1.8 parts, 2 parts, 2.2 parts, 2.4 parts, 2.6 parts, 2.8 parts, 3 parts, 3.2 parts, 3.4 parts, 3.6 parts, 3.8 parts, 4 parts, 4.2 parts, 4.4 parts, 4.6 parts, 4.8 parts, 5 parts, 5.2 parts, 5.4 parts, 5.6 parts, 5.8 parts, 6 parts, etc.
[0095] As an optional embodiment, the antioxidant content in the composition containing soy isoflavones is 0.01 to 2 parts, for example, it can be 0.01 parts, 0.2 parts, 0.4 parts, 0.6 parts, 0.8 parts, 1 part, 1.2 parts, 1.4 parts, 1.6 parts, 1.8 parts, 2 parts, etc.
[0096] As an optional embodiment, the content of the chelating agent in the composition containing soy isoflavones is 0.01 to 0.2 parts, for example, 0.01 parts, 0.02 parts, 0.04 parts, 0.06 parts, 0.08 parts, 0.1 parts, 0.12 parts, 0.14 parts, 0.16 parts, 0.18 parts, 0.2 parts, etc.
[0097] As an optional embodiment, the preservative content in the composition containing soy isoflavones is 0.01 to 0.6 parts, for example, 0.01 parts, 0.02 parts, 0.05 parts, 0.1 parts, 0.15 parts, 0.2 parts, 0.25 parts, 0.3 parts, 0.35 parts, 0.4 parts, 0.45 parts, 0.5 parts, 0.55 parts, 0.6 parts, etc.
[0098] In a preferred embodiment, the composition of soy isoflavones comprises, by weight parts: 0.5-4 parts soy isoflavones, 8-25 parts oil phase matrix, 3-15 parts liposome excipients, 1-4 parts transdermal absorption promoter, 2-8 parts humectant, 1-3 parts emulsifier, 0.05-0.5 parts antioxidant, 0.02-0.1 parts chelating agent, and 0.05-0.2 parts preservative.
[0099] As an optional embodiment, the composition containing soy isoflavones comprises, by weight percentage: 0.1-10% soy isoflavones, 3-30% oil phase matrix, 1-20% liposome excipients, 0.05-5% transdermal absorption enhancer, 1-20% humectant, 0.2-6% emulsifier, 0.01-2 parts antioxidant, 0.01-0.2% chelating agent, 0.01-0.6% preservative, and the balance being solvent.
[0100] As an optional implementation, the content of soy isoflavones is 0.1-10% based on the total mass of the composition containing soy isoflavones as 100%, for example, it can be 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, etc.
[0101] As an optional implementation, based on the total mass of the composition containing soy isoflavones as 100%, the content of the oil phase matrix is 3-30%, for example, it can be 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, 10.5%, 11%, 11.5%, 12%, 12.5%, 13%, 13.5%, 14%, 14.5%, 15%, 15.5%, 16%, 16.5%, 17%, 17.5%, 18%, 18.5%, 19%, 19.5%, 20%, 20.5%, 21%, 21.5%, 22%, 22.5%, 23%, 23.5%, 24%, 24.5%, 25%, 25.5%, 26%, 26.5%, 27%, 27.5%, 28%, 28.5%, 29%, 29.5%, 30%, etc.
[0102] As an optional implementation, based on the total mass of the composition containing soy isoflavones as 100%, the content of liposome excipients is 1-20%, for example, it can be 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, 10.5%, 11%, 11.5%, 12%, 12.5%, 13%, 13.5%, 14%, 14.5%, 15%, 15.5%, 16%, 16.5%, 17%, 17.5%, 18%, 18.5%, 19%, 19.5%, 20%, etc.
[0103] As an optional implementation, the content of the transdermal absorption enhancer is 0.05-5% based on the total mass of the composition containing soy isoflavones as 100%, for example, it can be 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, etc.
[0104] As an optional implementation, the content of the humectant is 1-20% based on 100% of the total mass of the composition containing soy isoflavones, for example, it can be 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, 10.5%, 11%, 11.5%, 12%, 12.5%, 13%, 13.5%, 14%, 14.5%, 15%, 15.5%, 16%, 16.5%, 17%, 17.5%, 18%, 18.5%, 19%, 19.5%, 20%, etc.
[0105] As an optional implementation, based on the total mass of the composition containing soy isoflavones (100%), the content of emulsifier is 0.2-6%, for example, it can be 0.2%, 0.4%, 0.6%, 0.8%, 1%, 1.2%, 1.4%, 1.6%, 1.8%, 2%, 2.2%, 2.4%, 2.6%, 2.8%, 3%, 3.2%, 3.4%, 3.6%, 3.8%, 4%, 4.2%, 4.4%, 4.6%, 4.8%, 5%, 5.2%, 5.4%, 5.6%, 5.8%, 6%, etc.
[0106] As an optional implementation, the antioxidant content is 0.01-2% based on the total mass of the composition containing soy isoflavones as 100%, for example, it can be 0.01%, 0.2%, 0.4%, 0.6%, 0.8%, 1%, 1.2%, 1.4%, 1.6%, 1.8%, 2%, etc.
[0107] As an optional implementation, the content of the chelating agent is 0.01~0.2% based on the total mass of the composition containing soy isoflavones as 100%, for example, it can be 0.02%, 0.04%, 0.06%, 0.08%, 0.1%, 0.12%, 0.14%, 0.16%, 0.18%, 0.2%, etc.
[0108] As an optional implementation, based on the total mass of the composition containing soy isoflavones as 100%, the content of preservative is 0.01~0.6%, for example, it can be 0.01%, 0.02%, 0.05%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, 0.5%, 0.55%, 0.6%, etc.
[0109] In a preferred embodiment, the composition containing soy isoflavones comprises, by weight percentage: 0.5-4% soy isoflavones, 8-25% oil phase matrix, 3-15% liposome excipients, 1-4% transdermal absorption enhancer, 2-8% humectant, 1-3% emulsifier, 0.05-0.5% antioxidant, 0.02-0.1% chelating agent, 0.05-0.2% preservative, and the balance being solvent.
[0110] As an optional embodiment, the solvent in the composition containing soy isoflavones is water.
[0111] As an optional embodiment, the pH of the soy isoflavone composition is 4.0 to 8.0, for example, it can be 4.0, 4.2, 4.4, 4.6, 4.8, 5.0, 5.2, 5.4, 5.6, 5.8, 6.0, 6.2, 6.4, 6.6, 6.8, 7.0, 7.2, 7.4, 7.6, 7.8, 8.0, etc.
[0112] In a preferred embodiment, the pH of the soy isoflavone composition is 5.5 to 7.5.
[0113] In a second aspect, the present invention provides a method for preparing the composition containing soy isoflavones as described in the first aspect, comprising: (1) The first liposome excipient, the second liposome excipient, soy isoflavones and the first solvent are mixed and the first solvent is removed by evaporation to obtain a lipid film; the moisturizer, part of the emulsifier and the second solvent are mixed to obtain a mixture A; the lipid film and the mixture A are mixed to obtain a primary emulsion; the primary emulsion is subjected to high pressure homogenization to obtain nano-sized liposomes; (2) Mix the oil phase matrix, antioxidant and transdermal absorption enhancer to obtain the oil phase; mix the remaining emulsifier, chelating agent, preservative and second solvent to obtain mixture B; mix the oil phase and mixture B to obtain the cream matrix; (3) The nano-sized liposomes and the cream matrix are mixed and subjected to shearing and homogenization to obtain the composition containing soy isoflavones.
[0114] It should be noted that step (1) is for the preparation of nanoscale liposomes: the first liposome excipient (such as soybean lecithin), the second liposome excipient (such as cholesterol), and soybean isoflavones are dissolved together in the first solvent (such as 75% ethanol), and a homogeneous and dense lipid film is formed by rotary evaporation; this process allows phospholipid molecules to be arranged in an orderly manner in the solid phase, and the second liposome excipient (such as cholesterol) is fully embedded between the phospholipid bilayer of the first liposome excipient (such as soybean lecithin), forming a membrane skeleton precursor with a stable structure and moderate fluidity; at the same time, soybean isoflavones are uniformly dispersed in the hydrophobic region or interface due to their lipid solubility, laying the foundation for subsequent efficient encapsulation; subsequently, a mixture A containing a humectant (such as glycerol) and a portion of an emulsifier (such as polysorbate 80) is added for hydration. The humectant (such as glycerol) can adjust the osmotic pressure of the aqueous phase and reduce the risk of liposome swelling and rupture, while an appropriate amount of nonionic emulsifier helps to reduce interfacial tension, promote the full hydration of the lipid film and self-assembly into vesicles. After high-pressure homogenization, under the action of high shear force and cavitation effect, the large-sized multilayer vesicles in the colostrum are broken and reorganized to form nanoscale liposomes with uniform particle size and narrow distribution, which significantly improves their ability to penetrate the stratum corneum and enhances the regularity and stability of the membrane structure.
[0115] It should be noted that step (2) is to prepare the cream matrix: the cream matrix is prepared by hot melt emulsification. The oil phase matrix (such as stearic acid, petrolatum), antioxidant (such as vitamin E) and transdermal absorption promoter (such as isopropyl palmitate) are premixed and heated to melt. This design not only ensures that the oil phase components are fully integrated, but more importantly, it makes the transdermal absorption promoter uniformly dispersed in the continuous oil phase, avoiding damage to the formed liposome bilayer membrane in subsequent processes. At the same time, the remaining emulsifier, chelating agent (such as disodium edetate), and preservative (such as propylparaben) are dissolved in the aqueous phase, which helps to stabilize the O / W interface during emulsification, prevent liposome aggregation and sedimentation, and inhibit the oxidation reaction catalyzed by metal ions through chelation, further protecting the integrity of unsaturated phospholipids in the bilayer membrane.
[0116] It should be noted that step (3) is to prepare the composition containing soy isoflavones: nano-sized liposomes are mixed with the cream matrix under relatively low temperature conditions and subjected to shear homogenization treatment; on the one hand, high temperature avoids phase change or rupture of liposome membranes, maintaining the integrity of their bilayer structure; on the other hand, by controlling the shear rate and time, the liposomes are uniformly dispersed in the cream system without destroying their vesicle structure, ensuring that their function as an active delivery carrier is preserved; finally, in the obtained composition, the liposomes exist stably in the continuous phase of the cream in the form of a "micro-carrier system", which not only plays the role of sustained release and targeted delivery of soy isoflavones, but also achieves efficient fusion and penetration between the bilayer membrane and the skin barrier by means of the synergistic perturbation effect of the transdermal promoter on the stratum corneum.
[0117] In summary, this stepwise preparation process precisely controls the formation environment, physical stability, and spatial distribution of the bilayer membrane, effectively avoiding the activity loss and structural damage that may be caused by traditional blending methods. It maximizes the biological advantages of liposomes as an intelligent delivery system and is the core guarantee for achieving the technical effects of "high transdermal efficiency, long-lasting sustained release, and mild safety" of this invention.
[0118] As an optional implementation, the first solvent includes any one or a combination of at least two of ethanol, propylene glycol, glycerol, and water.
[0119] In a preferred embodiment, the first solvent is an aqueous ethanol solution.
[0120] As an optional implementation, the percentage content of the ethanol aqueous solution is 70~80 vol%, for example, it can be 70 vol%, 71 vol%, 72 vol%, 73 vol%, 74 vol%, 75 vol%, 76 vol%, 77 vol%, 78 vol%, 79 vol%, 80 vol%, etc.
[0121] In a preferred embodiment, the percentage content of the ethanol aqueous solution is 75 vol.
[0122] As an optional implementation, the second solvent includes water.
[0123] As an optional implementation, in step (1), the mixing temperature of the first liposome excipient, the second liposome excipient, soy isoflavones and the first solvent is 45~55℃, for example, it can be 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, 51℃, 52℃, 53℃, 54℃, 55℃, etc.
[0124] As an optional implementation, in step (1), the evaporation temperature is 45~55℃, for example, it can be 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, 51℃, 52℃, 53℃, 54℃, 55℃, etc.
[0125] As an optional implementation, in step (1), the evaporation pressure is -0.10 to -0.05 MPa, for example, it can be -0.10 MPa, -0.09 MPa, -0.08 MPa, -0.07 MPa, -0.06 MPa, -0.05 MPa, etc.
[0126] As an optional implementation, in step (1), the temperature at which the lipid film and the mixture A are mixed is 38~48℃, for example, it can be 38℃, 39℃, 40℃, 41℃, 42℃, 43℃, 44℃, 45℃, 46℃, 47℃, 48℃, etc.
[0127] As an optional implementation, in step (1), the pressure of the high-pressure homogenization process is 80~150 MPa, for example, it can be 80 MPa, 85 MPa, 90 MPa, 95 MPa, 100 MPa, 105 MPa, 110 MPa, 115 MPa, 120 MPa, 125 MPa, 130 MPa, 135 MPa, 140 MPa, 145 MPa, 150 MPa, etc.
[0128] As an optional implementation, in step (1), the high-pressure homogenization process is performed 3 to 8 times, for example, 3, 4, 5, 6, 7, or 8 times.
[0129] As an optional implementation, in step (1), the emulsifier accounts for 15-70% of the total mass of the emulsifier, for example, it can be 5%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, etc.
[0130] In a preferred embodiment, in step (1), the emulsifier accounts for 30-60% of the total mass of the emulsifier.
[0131] As an optional implementation, in step (2), the temperature at which the oil phase matrix, antioxidant and transdermal absorption promoter are mixed is 65~75℃, for example, it can be 65℃, 66℃, 67℃, 68℃, 69℃, 70℃, 71℃, 72℃, 73℃, 74℃, 75℃, etc.
[0132] As an optional implementation, in step (2), the temperature at which the remaining emulsifier, chelating agent, preservative and second solvent are mixed is 65~75°C, for example, it can be 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, 75°C, etc.
[0133] As an optional implementation, step (2) includes: mixing the remaining emulsifier, chelating agent, preservative and second solvent to obtain mixture B.
[0134] As an optional implementation, in step (2), the temperature at which the remaining emulsifier, chelating agent, preservative and second solvent are mixed is 65~75°C, for example, it can be 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, 75°C, etc.
[0135] As an optional implementation, in step (2), the temperature at which the oil phase and the mixture B are mixed is 65~75℃, for example, it can be 65℃, 66℃, 67℃, 68℃, 69℃, 70℃, 71℃, 72℃, 73℃, 74℃, 75℃, etc.
[0136] As an optional implementation, in step (3), the mixing temperature of the nano-liposomes and the cream matrix is 40~50℃, for example, it can be 40℃, 41℃, 42℃, 43℃, 44℃, 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, etc.
[0137] It should be noted that in step (3) of the present invention, after the liposomes are prepared, they are mixed with the liposomes at low temperature to avoid high temperature damage to the liposome structure and ensure the stability of the liposomes.
[0138] As an optional implementation, in step (3), the rotation speed of the shearing homogenization process is 10,000~19,000 rpm, for example, it can be 10,000 rpm, 10,500 rpm, 11,000 rpm, 11,500 rpm, 12,000 rpm, 12,500 rpm, 13,000 rpm, 13,500 rpm, 14,000 rpm, 14,500 rpm, 15,000 rpm, 15,500 rpm, 16,000 rpm, 16,500 rpm, 17,000 rpm, 17,500 rpm, 18,000 rpm, 18,500 rpm, 19,000 rpm, etc.
[0139] As an optional implementation, in step (3), the time for the shearing and homogenization process is 10 to 50 minutes, for example, it can be 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, etc.
[0140] As an optional implementation, step (3) further includes the following steps after the shearing and homogenization process: The treated liquid was cooled to below 40°C, and the pH of the liquid was adjusted to 5.5-7.5 using a pH adjuster. Water was then added to obtain the composition containing soy isoflavones.
[0141] As an optional embodiment, the composition containing soy isoflavones is prepared by the following steps: (1) Liposome preparation: Soybean lecithin, cholesterol, and soy isoflavones were mixed and added to an ethanol-water solution. The mixture was stirred at a constant temperature of 50±5℃ until completely dissolved. The solution was then transferred to a rotary evaporator and evaporated at 50±5℃ and -0.10~-0.05 MPa to form a lipid film. Glycerin, a portion of polysorbate 80, and a portion of purified water were mixed and miscible. This solution was added to the lipid film at 38~48℃ and stirred to form a proemulsion. The solution was then homogenized using a high-pressure homogenizer at a working pressure of 80~150 MPa for 3~8 cycles to form nano-sized liposomes. The liposomes were then kept at 40~50℃ for later use.
[0142] (2) Preparation of cream base: Weigh stearic acid and petrolatum, heat to 70±5℃ and stir to melt. Add vitamin E and stir to dissolve. Add isopropyl palmitate and stir until fully combined. Keep warm at 70±5℃ for later use as the oil phase. Mix the remaining polysorbate 80, propylparaben, disodium edetate and some purified water. Stir at 70±5℃ until the materials dissolve to form an aqueous phase. Keep warm for later use. Add the aqueous phase to the oil phase at 70±5℃ and stir to emulsify to obtain the cream base. Cool the cream base to 40~50℃ for later use.
[0143] (3) Mixing and filling: Slowly add the liposome solution to the cream base at 40~50℃, stir until homogeneous, and then shear homogenize at 10000~19000rpm for 10~50 min to ensure the system is homogeneous; cool to below 40℃, check the pH value (control the pH value between 5.5 and 7.5, and fine-tune it with citric acid and / or triethanolamine if it deviates), add purified water, stir until homogeneous, and then fill.
[0144] Thirdly, the present invention provides the use of the composition containing soy isoflavones as described in the first aspect in the preparation of cosmetics.
[0145] The present invention will be further illustrated below by way of examples. Unless otherwise specified, the materials in the examples are prepared according to existing methods or purchased directly from the market.
[0146] Example 1 This embodiment provides a composition containing soy isoflavones, which comprises, by weight percentage: 1% soy isoflavones, 6% soy phospholipids, 1.5% cholesterol, 3% isopropyl palmitate, 5% stearic acid, 3% petrolatum, 2% polysorbate 80, 4% glycerin, 0.1% propylparaben, 0.2% vitamin E, 0.05% disodium edetate, and the balance being purified water.
[0147] The composition containing soy isoflavones described in this embodiment was prepared by the following steps: (1) Liposome preparation: 0.6 kg of soybean lecithin, 0.15 kg of cholesterol, and 0.1 kg of soybean isoflavones were mixed and added to a 75% ethanol aqueous solution. The mixture was stirred at a constant temperature of 50±2℃ until completely dissolved. The solution was then transferred to a rotary evaporator and evaporated at 50±2℃ and -0.09~-0.07 MPa to form a lipid film. 0.4 kg of glycerol, 0.09 kg of polysorbate 80, and 3 kg of purified water were stirred until miscible. This solution was added to the lipid film at 45±5℃ and stirred to form a proemulsion. The proemulsion was then homogenized into a liposome solution using a high-pressure homogenizer at a working pressure of 110±10 MPa for 5 homogenizations to form nano-sized liposomes. The liposomes were then kept at 45±5℃ for later use.
[0148] (2) Preparation of cream base: Weigh 0.5 kg of stearic acid and 0.3 kg of petrolatum, heat to 70±2℃ and stir to melt. Continue to add 0.02 kg of vitamin E and stir to dissolve. Then add 0.3 kg of isopropyl palmitate and stir until fully combined. Keep warm at 70±2℃ for later use as the oil phase. Dissolve 0.11 kg of polysorbate 80, 0.01 kg of propylparaben, 5 g of disodium edetate and 3 kg of purified water at 70±2℃ to form the aqueous phase. Keep warm for later use. Add the aqueous phase to the oil phase at 70±2℃ and stir to emulsify to obtain the cream matrix. Cool to 45±5℃ for later use.
[0149] (3) Mixing and filling: At 45±5℃, the liposome solution was slowly added to the cream matrix and stirred until homogeneous. The mixture was then sheared and homogenized at 10000 rpm for 30 min to ensure uniformity. The mixture was cooled to below 40℃, and the pH value was checked (controlled between 5.5 and 7.5; if it deviates, it was finely adjusted with 0.1 mol / L citric acid or triethanolamine solution). Purified water was added to bring the volume to 10 kg, and the mixture was stirred until homogeneous before filling.
[0150] Example 2 This embodiment provides a composition containing soy isoflavones, which comprises, by weight percentage: 1.5% soy isoflavones, 11% soy lecithin, 4% cholesterol, 2% isopropyl palmitate, 7% stearic acid, 6% petrolatum, 3% polysorbate 80, 6% glycerin, 0.07% propylparaben, 0.5% vitamin E, 0.03% disodium edetate, and the balance being purified water.
[0151] The composition containing soy isoflavones described in this embodiment was prepared by the following steps: (1) Liposome preparation: 1.1 kg of soybean lecithin, 0.4 kg of cholesterol, and 0.15 kg of soybean isoflavones were mixed and added to a 75% ethanol aqueous solution. The mixture was stirred at a constant temperature of 50±2℃ until completely dissolved. The solution was then transferred to a rotary evaporator and evaporated at 50±2℃ and -0.09~-0.07 MPa to form a lipid film. 0.6 kg of glycerol, 0.13 kg of polysorbate 80, and 3 kg of purified water were stirred until miscible. This solution was added to the lipid film at 45±5℃ and stirred to form a proemulsion. The proemulsion was then homogenized into a liposome solution using a high-pressure homogenizer at a working pressure of 110±10 MPa for 5 homogenizations to form nano-sized liposomes. The liposomes were then kept at 45±5℃ for later use.
[0152] (2) Preparation of cream base: Weigh 0.7 kg of stearic acid and 0.6 kg of petrolatum, heat to 70±2℃ and stir to melt. Continue to add 0.05 kg of vitamin E and stir to dissolve. Then add 0.2 kg of isopropyl palmitate and stir until fully combined. Keep warm at 70±2℃ for later use as the oil phase. Dissolve 0.17 kg of polysorbate 80, 7 g of propylparaben, 3 g of disodium edetate and 2 kg of purified water at 70±2℃ to form the aqueous phase. Keep warm for later use. Add the aqueous phase to the oil phase at 70±2℃ and stir to emulsify to obtain the cream base. Cool to 45±5℃ for later use.
[0153] (3) Mixing and filling: At 45±5℃, the liposome solution was slowly added to the cream matrix and stirred until homogeneous. Then, the mixture was sheared and homogenized at 10000 rpm for 30 min to ensure uniformity. The mixture was cooled to below 40℃, and the pH value was checked (controlled between 5.5 and 7.5; if it deviates, it was finely adjusted with 0.1 mol / L citric acid or triethanolamine solution). The purified water was added to a final volume of 10 kg, stirred until homogeneous, and then filled into the final product.
[0154] Example 3 This embodiment provides a composition containing soy isoflavones, which comprises, by weight percentage: 2% soy isoflavones, 7% soy lecithin, 2% cholesterol, 1% isopropyl palmitate, 10% stearic acid, 5% petrolatum, 1.5% polysorbate 80, 8% glycerin, 0.15% propylparaben, 0.05% vitamin E, 0.08% disodium edetate, and the balance being purified water.
[0155] The composition containing soy isoflavones described in this embodiment was prepared by the following steps: (1) Liposome preparation: 0.7 kg of soybean lecithin, 0.2 kg of cholesterol, and 0.2 kg of soybean isoflavones were mixed and added to a 75% ethanol aqueous solution. The mixture was stirred at a constant temperature of 50±2℃ until completely dissolved. The solution was then transferred to a rotary evaporator and evaporated at 50±2℃ and -0.09~-0.07 MPa to form a lipid film. 0.8 kg of glycerol, 0.075 kg of polysorbate 80, and 4 kg of purified water were stirred until miscible. This solution was added to the lipid film at 45±5℃ and stirred to form a proemulsion. The proemulsion was then homogenized into a liposome solution using a high-pressure homogenizer at a working pressure of 110±10 MPa for 5 homogenizations to form nano-sized liposomes. The liposomes were then kept at 45±5℃ for later use.
[0156] (2) Preparation of cream base: Weigh 1.0 kg of stearic acid and 0.5 kg of petrolatum, heat to 70±2℃ and stir to melt. Continue to add 0.005 kg of vitamin E and stir to dissolve. Then add 0.1 kg of isopropyl palmitate and stir until fully combined. Keep warm at 70±2℃ for later use as the oil phase. Dissolve 0.075 kg of polysorbate 80, 0.015 kg of propylparaben, 8 g of disodium edetate and 2 kg of purified water at 70±2℃ to form the aqueous phase. Keep warm for later use. Add the aqueous phase to the oil phase at 70±2℃ and stir to emulsify to obtain the cream matrix. Cool to 45±5℃ for later use.
[0157] (3) Mixing and filling: The liposome solution was slowly added to the cream base at 45±5℃ and stirred until homogeneous. The mixture was then sheared and homogenized at 12000 rpm for 20 min to ensure uniformity. The mixture was cooled to below 40℃ and the pH value was checked (controlled between 5.5 and 7.5; if it deviates, it was finely adjusted with 0.1 mol / L citric acid or triethanolamine solution). The purified water was added to a final volume of 10 kg and stirred until homogeneous before filling.
[0158] Example 4 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that soy lecithin is replaced with an equal mass of hydrogenated soy lecithin and cholesterol is replaced with an equal mass of lanosterol. The other steps are the same as in Example 1.
[0159] Example 5 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that stearic acid is replaced with an equal mass of cetearyl alcohol and petrolatum is replaced with an equal mass of liquid paraffin. The other steps are the same as in Example 1.
[0160] Example 6 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that isopropyl palmitate is replaced with an equal mass of lauryl acetone, while the other steps are the same as in Example 1.
[0161] Example 7 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that glycerol is replaced with an equal mass of propylene glycol, while the other steps are the same as in Example 1.
[0162] Example 8 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that polysorbate 80 is replaced with an equal mass of polysorbate 60, while the other steps are the same as in Example 1.
[0163] Example 9 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that vitamin E is replaced with an equal mass of propyl gallate, while the other steps are the same as in Example 1.
[0164] Example 10 This embodiment provides a composition containing soy isoflavones, which differs from Example 1 only in that disodium edetate is replaced with an equal mass of gluconic acid-δ-lactone, while the other steps are the same as in Example 1.
[0165] Comparative Example 1 This comparative example provides a composition containing soy isoflavones, wherein the composition containing soy isoflavones comprises, by mass percentage: 1% soy isoflavones, 6% soy phospholipids, 1.5% cholesterol, 5% stearic acid, 3% petrolatum, 2% polysorbate, 4% glycerin, 0.1% propylparaben, 0.2% vitamin E, 0.05% disodium edetate, and the balance being purified water.
[0166] The composition containing soy isoflavones described in this comparative example was prepared by the following steps: (1) Liposome preparation: 0.6 kg of soybean lecithin, 0.15 kg of cholesterol, and 0.1 kg of soybean isoflavones were mixed and added to a 75% ethanol aqueous solution. The mixture was stirred at a constant temperature of 50±2℃ until completely dissolved. The solution was then transferred to a rotary evaporator and evaporated at 50±2℃ and -0.09~-0.07 MPa to form a lipid film. 0.4 kg of glycerol, 0.09 kg of polysorbate 80, and 3 kg of purified water were stirred until miscible. This solution was added to the lipid film at 45±5℃ and stirred to form a proemulsion. The proemulsion was then homogenized into a liposome solution using a high-pressure homogenizer at a working pressure of 110±10 MPa for 5 homogenizations to form nano-sized liposomes. The liposomes were then kept at 45±5℃ for later use.
[0167] (2) Preparation of cream base: Weigh 0.5 kg of stearic acid and 0.3 kg of petrolatum, heat to 70±2℃ and stir to melt. Continue to add 0.02 kg of vitamin E and stir to dissolve until fully integrated with the oil phase. Keep warm at 70±2℃ for later use as the oil phase. Dissolve 800.11 kg of polysorbate, 0.01 kg of propylparaben, 5 g of disodium edetate and 3 kg of purified water at 70±2℃ to form the aqueous phase. Keep warm for later use. Add the aqueous phase to the oil phase at 70±2℃ and stir to emulsify to obtain the cream matrix. Cool to 45±5℃ for later use.
[0168] (3) Mixing and filling: At 45±5℃, the liposome solution was slowly added to the cream matrix and stirred until homogeneous. The mixture was then sheared and homogenized at 10000 rpm for 30 min to ensure uniformity. The mixture was cooled to below 40℃, and the pH value was checked (controlled between 5.5 and 7.5; if it deviates, it was finely adjusted with 0.1 mol / L citric acid or triethanolamine solution). The purified water was added to bring the total volume to 10 kg, and the mixture was stirred until homogeneous before filling.
[0169] Comparative Example 2 This comparative example provides a composition containing soy isoflavones, wherein the composition containing soy isoflavones comprises, by mass percentage: 1% soy isoflavones, 3% isopropyl palmitate, 5% stearic acid, 10% petrolatum, 2% polysorbate 80, 4% glycerin, 0.1% propylparaben, 0.2% vitamin E, 0.05% disodium edetate, and the balance being purified water.
[0170] The composition containing soy isoflavones described in this comparative example was prepared by the following steps: (1) Weigh 0.5 kg of stearic acid and 1 kg of petrolatum, heat to 70±2℃ and stir to melt, add 0.3 kg of isopropyl palmitate and stir until fully combined, continue to add 0.02 kg of vitamin E and stir to dissolve, keep warm at 70±2℃ for later use as the oil phase; (2) Add 0.1 kg of soy isoflavones to 0.2 kg of glycerol and 3 kg of purified water, and shear at 2000 rpm for 10 min using a high-speed shear disperser to form a fine dispersion; (3) Take 3 kg of purified water, add 0.2 kg of polysorbate 80, 0.2 kg of glycerol, 5 g of disodium edetate and 0.01 kg of propylparaben, heat to 70±2℃ and stir to dissolve, then add soybean isoflavone-glycerol dispersion to the aqueous phase, stir evenly and heat to 70±2℃, keep warm for later use. (4) Keep the temperature of the oil phase and water phase at 70±2℃, slowly add the water phase to the oil phase, stir for 15 min to form the pre-emulsion, homogenize the pre-emulsion at 8000 rpm for 10 min, and then homogenize at 12000 rpm for 20 min; after homogenization, cool the cream to below 40℃, test the pH value (control it at 5.5~7.5, if it deviates, finely adjust it with 0.1 mol / L citric acid or triethanolamine solution), add purified water to 10 kg, stir evenly and fill.
[0171] Comparative Example 3 This comparative example provides a composition containing soy isoflavones, wherein the composition contains, by weight percentage: 1% soy isoflavones, 5% stearic acid, 10% petrolatum, 2% polysorbate 80, 4% glycerin, 0.1% propylparaben, 0.2% vitamin E, 0.05% disodium edetate, and the balance being purified water.
[0172] The composition containing soy isoflavones described in this comparative example was prepared by the following steps: (1) Weigh 0.5 kg of stearic acid and 1 kg of petrolatum, heat to 70±2℃ and stir to melt, then add 0.02 kg of vitamin E and stir to dissolve, keep warm at 70±2℃ for later use as the oil phase; (2) Add 0.1 kg of soy isoflavones to 0.2 kg of glycerol and 3 kg of purified water, and shear at 2000 rpm for 10 min using a high-speed shear disperser to form a fine dispersion; (3) Take 3 kg of purified water, add 0.2 kg of polysorbate 80, 0.2 kg of glycerol, 5 g of disodium edetate and 0.01 kg of propylparaben, heat to 70±2℃ and stir to dissolve, then add soybean isoflavone-glycerol dispersion to the aqueous phase, stir evenly and heat to 70±2℃, keep warm for later use. (4) Keep the temperature of the oil phase and water phase at 70±2℃, slowly add the water phase to the oil phase, stir for 15 min to form the pre-emulsion, homogenize the pre-emulsion at 8000 rpm for 10 min, and then homogenize at 12000 rpm for 20 min; after homogenization, cool the cream to below 40℃, test the pH value (control it at 5.5~7.5, if it deviates, use 0.1 mol / L citric acid or triethanolamine solution to finely adjust), add purified water to 10 kg, stir evenly and fill.
[0173] Comparative Example 4 This comparative example provides a composition containing soy isoflavones, which differs from Example 1 only in that soy lecithin is not added, and the cholesterol content is increased to 0.75 kg. The other steps are the same as in Example 1.
[0174] Comparative Example 5 This comparative example provides a composition containing soy isoflavones, which differs from Example 1 only in that no cholesterol is added and the content of soy lecithin is increased to 0.75 kg, while the other steps are the same as in Example 1.
[0175] Test Example 1 In vitro transdermal permeability test evaluation Test samples: Soy isoflavone-containing compositions provided in Examples 1-10 and Soy isoflavone-containing compositions provided in Comparative Examples 1-5.
[0176] Test Methods: For the transdermal permeation test, pigskin was used to simulate human epidermal skin. Pigskin was cut into 3cm diameter circles, rinsed in physiological saline, and used as a transdermal barrier. A Logan fully automated transdermal diffusion sampling system was used, with physiological saline as the transdermal receiving medium. The transdermal absorption test was conducted at a constant temperature of 32℃ and a constant flow rate of 600 r / min. The sample loading was 20 mg, and samples were taken at 2, 4, 6, 8, 12, 16, 20, and 24 hours. The receiving medium was replenished after each sampling. Transdermal diffusion tests were performed on samples of formulations with different prescriptions. High-performance liquid chromatography (HPLC) was used to determine the content of soy isoflavones and the amount retained in the skin.
[0177] The specific test results are shown in Table 1 below: Table 1
[0178] As shown in Table 1, there are significant differences in intradermal retention and cumulative permeation rates among different types of formulations: the compositions containing soy isoflavones provided in Examples 1-10 have the highest intradermal retention and cumulative permeation rates, followed by Comparative Examples 4 and 5 (containing only a single liposome excipient and a transdermal penetration enhancer), then Comparative Example 1 (liposome cream without a transdermal penetration enhancer), and finally Comparative Example 2 (ordinary cream with added transdermal penetration enhancer) and Comparative Example 3 (ordinary cream without a transdermal penetration enhancer). This indicates that the liposome structure can significantly increase the retention and transdermal absorption efficiency of soy isoflavones in the skin, and the addition of a transdermal penetration enhancer can also improve the intradermal retention and transdermal absorption efficiency to a certain extent. The combined effect of liposomes and transdermal penetration enhancers is the most prominent.
[0179] Test Example 2 Stability test Test samples: Soy isoflavone-containing compositions provided in Examples 1-10 and Soy isoflavone-containing compositions provided in Comparative Examples 1-3.
[0180] Test method: After filling the aluminum tube, place it under high temperature (40℃ / RH75%) stability test and accelerated (30℃ / RH65%) stability test.
[0181] Test pass criteria: Description of appearance: A uniform and smooth pale yellow cream is marked as OK, while an uneven pale yellow cream is marked as NG.
[0182] Whether the layers separate: If no layers separate after centrifugation at 2000 rpm for 20 min, it is marked as OK; if layers separate after centrifugation at 2000 rpm for 20 min, it is marked as NG.
[0183] The specific test results are shown in Table 2 below: Table 2
[0184] As shown in Table 2, the compositions containing soy isoflavones provided in Examples 1-10 and Comparative Example 1 all passed the high-temperature (40℃ / RH 75%) and accelerated (30℃ / RH 65%) stability tests, while the stability of Comparative Examples 2 and 3 was slightly worse. This indicates that the compositions containing soy isoflavones of the present invention remain stable under high temperature and high humidity conditions, demonstrating excellent environmental tolerance, effectively preventing degradation of active ingredients, and ensuring stable efficacy throughout the shelf life.
[0185] This feature extends the product's shelf life, reduces storage and transportation requirements, and enhances convenience and safety in practical applications.
[0186] Test Example 3 Encapsulation rate evaluation Test samples: Compositions containing soy isoflavones provided in Example 1, Comparative Example 4 and Comparative Example 5.
[0187] Test method: Accurately weigh 0.5 g of each sample, dilute with physiological saline to 5 mL to obtain the sample stock solution, place it into a dialysis bag with a molecular weight cutoff of 8000~14000 Da, seal it, and place it in 500 mL of physiological saline dialysis medium. Dialyze at 37℃ and 100 r / min for 24 h with constant temperature shaking (the dialysis medium is changed every 6 h to ensure equilibrium is reached). After dialysis, the content of soy isoflavones is determined by high performance liquid chromatography (HPLC) (denoted as W1, i.e., the mass of encapsulated soy isoflavones); take another 5 mL of the sample stock solution and determine the total soy isoflavone content by HPLC (denoted as W2); the encapsulation efficiency (EE%) is calculated by the formula: EE% = (W1 / W2)×100%.
[0188] The specific test results are shown in Table 3 below: Table 3
[0189] High encapsulation efficiency can improve the stability and transdermal sustained-release effect of soy isoflavones. Example 1 showed an encapsulation efficiency of 92.3%, confirming that the combination of soy phospholipids and cholesterol can efficiently encapsulate soy isoflavones; in comparative examples 4 and 5, the encapsulation efficiency was only 71.5%~72.3% after the absence of a single liposome excipient, verifying the synergistic effect of phospholipids and cholesterol, both of which are indispensable.
[0190] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.
Claims
1. A composition containing soy isoflavones, characterized in that, The composition containing soy isoflavones includes soy isoflavones, oil phase matrix, liposome excipients, transdermal absorption enhancers, moisturizers, emulsifiers, antioxidants, chelating agents, and preservatives. The liposome excipients include a first liposome excipient as a membrane skeleton material and a second liposome excipient as a membrane regulator material.
2. The composition containing soy isoflavones according to claim 1, characterized in that, The oil phase matrix includes fat-soluble polymers and / or small molecule oils; The fat-soluble polymer is selected from any one or a combination of at least two of polysiloxanes, fatty acid polyesters, and polyolefins; the small molecule oil is selected from any one or a combination of at least two of vegetable oils, animal oils, mineral oils, and synthetic oils. Preferably, the oil phase matrix is any one or a combination of at least two of the following: dimethyl silicone oil, polyglycerol fatty acid ester, polybutene, olive oil, castor oil, lanolin, beeswax, petrolatum, liquid paraffin, white oil, cetearyl alcohol, cetyl alcohol, stearic acid, isopropyl palmitate, caprylic / capric triglyceride, and isopropyl myristate. Preferably, the oil phase matrix is a mixture of stearic acid and petrolatum; Preferably, the mass ratio of stearic acid to petrolatum is (1~29):(1~20).
3. The composition containing soy isoflavones according to claim 1, characterized in that, The first liposome excipient includes any one or a combination of at least two of the following: soybean lecithin, egg yolk lecithin, hydrogenated soybean lecithin, dipalmitoylphosphatidylcholine, distearate phosphatidylcholine, dioleoylphosphatidylethanolamine, phosphatidylcholine, phosphatidylglycerol, and medium-chain triglycerides, preferably soybean lecithin. Preferably, the second liposome excipient comprises any one or a combination of at least two of cholesterol, sitosterol, stigmasterol, cholesterol succinate, vitamin E, stearylamine, octadecylamine, and behenyl glycerol, with cholesterol being the most preferred. Preferably, the liposome excipient is a mixture of soybean lecithin and cholesterol; Preferably, the mass ratio of soybean phospholipids to cholesterol is (1~10):1, more preferably (1.5~8):
1.
4. The composition containing soy isoflavones according to claim 1, characterized in that, The transdermal absorption enhancer includes any one or a combination of at least two of isopropyl palmitate, menthol, borneol, oleic acid, and laurocapram, preferably isopropyl palmitate; Preferably, the moisturizer includes any one or a combination of at least two of polyol moisturizers, natural moisturizing factors, high molecular weight biochemical moisturizers, and amino acid moisturizers, and more preferably any one or a combination of at least two of astragalus polysaccharide, sodium hyaluronate, dipotassium glycyrrhizate, glycerin, polyethylene glycol, sorbitol, maltitol, aloe vera gel, sodium lactate, and squalane, and more preferably glycerin; Preferably, the emulsifier includes any one or a combination of at least two of alkyl glycoside emulsifiers, polyol ester emulsifiers, copan emulsifiers, Tween emulsifiers, phosphate ester emulsifiers, fatty alcohol polyether emulsifiers, polyglycerol emulsifiers, and polymeric compound emulsifiers. More preferably, it includes any one or a combination of at least two of stearyl alcohol polyoxyethylene ether-721, sucrose ester, polysorbate 80, polysorbate 60, Span 80, and glyceryl monostearate. More preferably, it includes polysorbate 80.
5. The composition containing soy isoflavones according to claim 1, characterized in that, The antioxidant includes any one or a combination of at least two of sodium bisulfite, vitamin E, lauryl gallate, propyl gallate, ferulic acid, butylated hydroxytoluene, magnesium ascorbate phosphate, and sodium ascorbate phosphate, preferably vitamin E; Preferably, the chelating agent comprises any one or a combination of at least two of gluconate-δ-lactone, sodium citrate, and disodium edetate, preferably disodium edetate; Preferably, the composition containing soy isoflavones further includes a pH adjuster; Preferably, the pH adjuster includes any one or a combination of at least two of citric acid, malic acid, lactic acid, phosphoric acid, triethanolamine, and hydrochloric acid, preferably triethanolamine and / or citric acid; Preferably, the composition containing soy isoflavones further includes a preservative; Preferably, the preservative includes any one or a combination of at least two of the following: propylparaben, ethylparaben, methylparaben, benzalkonium bromide, benzalkonium chloride, and parabens, with propylparaben being the most preferred.
6. The composition containing soy isoflavones according to claim 1, characterized in that, The composition containing soy isoflavones comprises, by weight parts: 0.1-10 parts soy isoflavones, 3-30 parts oil phase matrix, 1-20 parts liposome excipients, 0.05-5 parts transdermal absorption enhancer, 1-20 parts humectant, 0.2-6 parts emulsifier, 0.01-2 parts antioxidant, 0.01-0.2 parts chelating agent, and 0.01-0.6 parts preservative; Preferably, the composition containing soy isoflavones comprises, by weight parts: 0.5-4 parts soy isoflavones, 8-25 parts oil phase matrix, 3-15 parts liposome excipients, 1-4 parts transdermal absorption enhancer, 2-8 parts humectant, 1-3 parts emulsifier, 0.05-0.5 parts antioxidant, 0.02-0.1 parts chelating agent, and 0.05-0.2 parts preservative; Preferably, the pH of the composition containing soy isoflavones is 4.0 to 8.0, and more preferably 5.5 to 7.
5.
7. A method for preparing a composition containing soy isoflavones according to any one of claims 1 to 6, characterized in that, The preparation method includes: (1) The first liposome excipient, the second liposome excipient, soy isoflavones and the first solvent are mixed and the first solvent is removed by evaporation to obtain a lipid film; the moisturizer, part of the emulsifier and the second solvent are mixed to obtain a mixture A; the lipid film and the mixture A are mixed to obtain a primary emulsion; the primary emulsion is subjected to high pressure homogenization to obtain nano-sized liposomes; (2) Mix the oil phase matrix, antioxidant and transdermal absorption enhancer to obtain the oil phase; mix the remaining emulsifier, chelating agent, preservative and second solvent to obtain mixture B; mix the oil phase and mixture B to obtain the cream matrix; (3) The nano-sized liposomes and the cream matrix are mixed and subjected to shearing and homogenization to obtain the composition containing soy isoflavones.
8. The method for preparing the composition containing soy isoflavones according to claim 7, characterized in that, The first solvent includes any one or a combination of at least two of ethanol, propylene glycol, glycerol, and water, preferably an aqueous solution of ethanol; Preferably, the percentage content of the ethanol aqueous solution is 70-80 vol%. Preferably, the second solvent comprises water; Preferably, in step (1), the mixing temperature of the first liposome excipient, the second liposome excipient, soy isoflavones and the first solvent is 45~55℃; Preferably, in step (1), the evaporation temperature is 45~55℃ and the evaporation pressure is -0.10~-0.05 MPa; Preferably, in step (1), the temperature at which the lipid film and mixture A are mixed is 38~48°C; Preferably, in step (1), the pressure of the high-pressure homogenization treatment is 80~150 MPa, and the number of high-pressure homogenization treatments is 3~8 times; Preferably, in step (1), the emulsifier accounts for 15-70% of the total mass of the emulsifier, more preferably 30-60%.
9. The method for preparing the composition containing soy isoflavones according to claim 7, characterized in that, In step (2), the mixing temperature of the oil phase matrix, antioxidant and transdermal absorption enhancer is 65~75℃; Preferably, in step (2), the temperature at which the remaining emulsifier, chelating agent, preservative, and second solvent are mixed is 65~75°C; Preferably, in step (2), the temperature at which the oil phase and the mixture B are mixed is 65~75℃; Preferably, in step (3), the mixing temperature of the nano-sized liposomes and the cream matrix is 40~50℃; Preferably, in step (3), the rotation speed of the shearing homogenization process is 10,000 to 19,000 rpm, and the time of the shearing homogenization process is 10 to 50 min; Preferably, in step (3), after the shearing and homogenization process, the following steps are further included: The treated liquid was cooled to below 40°C, and the pH of the liquid was adjusted to 5.5-7.5 using a pH adjuster. Water was then added to obtain the composition containing soy isoflavones.
10. The use of a composition containing soy isoflavones according to any one of claims 1 to 6 in the preparation of cosmetics.