A composition for maintaining the microecological barrier of private care and a method for balancing and regulating the same
Patent Information
- Application Number
- CN202610686378.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-05-19
- Publication Date
- 2026-08-18
AI Technical Summary
1、传统产品多采用月桂醇聚醚硫酸酯钠/月桂醇硫酸酯钠等高刺激阴离子表面活性剂,虽能实现清洁,但过度脱脂会破坏阴道正常的弱酸性环境,抑制乳酸杆菌等有益菌的定植,导致菌群失衡,出现越洗越干越洗越痒等问题,已有专利如CN105663001A公开了以N-酰基氨基酸表面活性剂为核心的护理液配方,但表面活性剂用量较高,对黏膜的长期影响仍有待优化;
1、本发明采用羧酸盐型谷氨酸表面活性剂与磺酸盐型两性表面活性剂复配体系,配合多级pH缓冲体系将产品pH精准控制在3.8~4.5,同时引入短链益生元、长链益生元与后生元代谢物的多维协同调控组分,能够在高效清洁的同时维持私密部位弱酸性环境,促进阴道共生乳酸杆菌增殖、抑制条件致病菌过度繁殖,解决了传统护理液越洗越干、越洗越痒的技术问题;
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Figure CN122582067A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of cosmetics or daily chemical products technology, and more specifically, to a composition for maintaining the microecological barrier of intimate care and a method for balancing and regulating it. Background Technology
[0002] Feminine wash is an important category of daily feminine hygiene products. It is applied to the vulva and belongs to the category of general cosmetic washes. In recent years, with the increasing awareness of women's health, feminine washes are upgrading from basic cleansing to nourishing. Microecological balance regulation, mucosal barrier repair, screening of natural active ingredients, and green manufacturing have become the key directions for technological development in the industry.
[0003] Current feminine hygiene solutions generally suffer from the following technical bottlenecks: 1. Traditional products often use highly irritating anionic surfactants such as sodium lauryl ether sulfate / sodium lauryl sulfate. Although they can achieve cleaning, excessive degreasing can disrupt the normal weakly acidic environment of the vagina, inhibit the colonization of beneficial bacteria such as lactobacilli, and lead to bacterial imbalance, resulting in problems such as dryness and itching after washing. There are patents such as CN105663001A that disclose a care solution formula with N-acyl amino acid surfactant as the core, but the amount of surfactant used is high, and the long-term effects on the mucosa still need to be optimized. 2. The mucosal epithelium of the private parts is relatively delicate. Most existing products only focus on cleaning and lack efficacy design for repairing the mucosal barrier, making it difficult to meet the repair needs of special groups such as postpartum, menopause, and post-medical aesthetic procedures. CN115554393A discloses a biological antibacterial gel that balances the structure of gynecological microecological flora, but it mainly relies on antibacterial ingredients such as lysozyme and does not involve the active regulation of the mucosal immune barrier. 3. The principle of pH-responsive gels has been reported in the existing literature. They remain stable in acidic environments and dissolve and release active ingredients when they come into contact with secretions and the pH increases. However, most of the existing technologies are still at the proof-of-concept level and lack system designs that can achieve differentiated release of active ingredients. 4. Traditional production processes have high energy consumption, poor biodegradability of surfactant systems, and insufficient recyclability of packaging materials.
[0004] Therefore, there is an urgent need to develop a feminine hygiene composition and its balance regulation method that can simultaneously achieve microecological balance regulation, multi-target repair of the mucosal barrier, and pH-responsive intelligent delivery. Summary of the Invention
[0005] In order to overcome the above-mentioned defects of the prior art, embodiments of the present invention provide a composition for maintaining the microecological barrier of intimate care and a method for balancing and regulating the thereof, so as to solve the problems mentioned in the background art.
[0006] To achieve the above objectives, the present invention provides the following technical solution: On one hand, the present invention provides a composition for maintaining a microecological barrier for intimate care, the composition comprising: Microecological balance regulating components, wherein the microecological balance regulating components include: A low-irritant surfactant compound system, wherein the low-irritant surfactant compound system is composed of a carboxylate-type glutamate surfactant and a sulfonate-type amphoteric surfactant in a mass ratio of 1.5~3:1~2, with a total concentration of 6~12% by weight. A multi-stage pH buffer system, comprising a lactic acid / sodium lactate primary buffer pair, a citric acid / sodium citrate secondary buffer pair, and a potassium dihydrogen phosphate / dipoxetine hydrogen phosphate tertiary buffer pair, wherein the molar ratio of lactic acid to sodium lactate is 1:0.8~1.2, the molar ratio of citric acid to sodium citrate is 1:0.5~2.0, and the total molar amount of potassium dihydrogen phosphate and diipoxetine hydrogen phosphate is 0.2~0.5 times the total molar amount of the primary buffer pair; A multidimensional prebiotic-metasecemic synergistic regulatory component, comprising short-chain prebiotics, long-chain prebiotics, and metabolites, wherein the short-chain prebiotics are a combination of fructooligosaccharides and galactooligosaccharides, with a total content of 0.5-2% by weight; the long-chain prebiotics are a combination of inulin and α-glucan oligosaccharides, with a total content of 0.3-1.5% by weight; and the metabolites comprise 0.1-0.5% by weight of Lactobacillus fermentation lysate and 0.2-0.8% by weight of a Lactobacillus fermentation metabolite composition. A multi-target mucosal barrier repair component, comprising: An antioxidant-anti-inflammatory synergistic system, wherein the antioxidant-anti-inflammatory synergistic system is composed of bisabolol, dipotassium glycyrrhizate, scutellaria baicalensis root extract, gentian root extract and asiaticoside composition in a mass ratio of 2~5:1~3:0.5~2:1~2:1~3, with a total content of 0.5~3% by weight. The tight junction protein expression-enhancing component comprises graded molecular weight sodium hyaluronate and ceramide NP phospholipid complex liposomes. The graded molecular weight sodium hyaluronate is composed of ultra-high molecular weight sodium hyaluronate, high molecular weight sodium hyaluronate, low molecular weight sodium hyaluronate, and oligomeric sodium hyaluronate in a mass ratio of 0.5~2:1~3:2~5:1~2, with a total content of 0.2~1% by weight. The ceramide NP phospholipid complex liposomes are prepared by mixing ceramide NP and hydrogenated lecithin in a mass ratio of 1:2~4, with a particle size of 80~150 nm and a content of 0.1~1% by weight. The antimicrobial peptide expression inducing component comprises yeast β-glucan, Tremella fuciformis polysaccharide, and a postbiotic composition of Lactobacillus johnsonii. The yeast β-glucan has a molecular weight of 50-200 kDa, a β-1,6 branching degree ≥30%, and a content of 0.2-1% by weight. The Tremella fuciformis polysaccharide has a degree of acetylation of 0.3-0.6, a molecular weight of 500-1500 kDa, and a content of 0.1-0.5% by weight. The Lactobacillus johnsonii postbiotic composition comprises heat-inactivated Lactobacillus johnsonii cells, cell wall components, and fermentation metabolites, with a content of 0.2-1% by weight. A pH-responsive smart delivery system, comprising: A composite polysaccharide interpenetrating network gel matrix is composed of carrageenan, pectin, sodium alginate, hydroxypropyl methylcellulose, and sodium carboxymethyl cellulose. Specifically, the carrageenan is a mixture of κ-type and ι-type carrageenan in a mass ratio of 2:1 to 1:2, with a total content of 0.3 to 1 wt%; the pectin has a degree of esterification of 25 to 35% and a content of 0.2 to 0.8 wt%; the sodium alginate has a guluronic acid to mannulic acid molar ratio of 0.5 to 1.5, a molecular weight of 80 to 400 kDa, and a content of 0.3 to 1 wt%; the hydroxypropyl methylcellulose has a methoxy group content of 28 to 30% and a hydroxypropoxy group content of 7 to 12%, with a content of 0.1 to 0.5 wt%; and the sodium carboxymethyl cellulose has a degree of substitution of 0.7 to 0.9 and a content of 0.1 to 0.5 wt%. A naturally derived pH-responsive osmotic pressure regulator, wherein the naturally derived pH-responsive osmotic pressure regulator is a low molecular weight alginate oligosaccharide with a molecular weight of 3~10kDa, a degree of polymerization of 20~60, and a content of 0.2~1% by weight.
[0007] Preferably, the carboxylate-type glutamate surfactant is selected from sodium lauroyl glutamate, disodium cocoyl glutamate, or a combination thereof, and the sulfonate-type amphoteric surfactant is a mixture of lauramidopropyl hydroxysulfonate betaine and cocamidopropyl betaine in a mass ratio of 1:1.
[0008] Preferably, in the gradient molecular weight sodium hyaluronate, the molecular weight of ultra-high molecular weight sodium hyaluronate is 1.2~1.8 MDa, the molecular weight of high molecular weight sodium hyaluronate is 0.8~1.2 MDa, the molecular weight of low molecular weight sodium hyaluronate is 8~50 kDa, and the molecular weight of oligomeric sodium hyaluronate is ≤10 kDa.
[0009] On the other hand, the present invention also provides a balance regulation method based on the above-mentioned composition for maintaining the microecological barrier of intimate care. The method includes: applying the composition to the intimate care area by rinsing; maintaining the composition in a liquid state at pH 3.8 to 4.5; and forming a high-viscosity gel layer when the pH rises to ≥5.0.
[0010] Preferably, the composition is prepared by the following steps: S1. Under conditions of ≤40℃, the low-irritant surfactant compound system is mixed with purified water and stirred until dissolved to obtain phase A; S2. Under conditions of ≤40℃, the multi-stage pH buffer system is dissolved in purified water to obtain a buffer solution. The multi-dimensional prebiotic-postbiotic synergistic regulatory components are added to phase A, stirred for 20~40min, and the pH is adjusted to 3.8~4.5 with the buffer solution to obtain phase B. S3. Under conditions of ≤35℃, the complex polysaccharide interpenetrating network gel matrix and the natural pH-responsive osmotic pressure regulator are pre-dispersed in glycerol or 1,3-propanediol, added to phase B at 400~600rpm, and stirred for 40~90min until completely hydrated; S4. Under conditions of ≤30℃, add the multi-target repair components of the mucosal barrier to the above gel system in sequence and stir for 20~40min; S5. The mixture obtained in step S4 is homogenized under high pressure at 15~30MPa 2~4 times to make the particle size D90≤800nm; S6. Aseptic filling.
[0011] The present invention also provides the application of the composition in the preparation of cosmetics for maintaining the microecological barrier of intimate care areas, wherein the cosmetic is a rinse-type vulvar care solution with a pH value of 3.8 to 4.5 and does not contain chemically synthesized antibiotics, sulfonamide antibacterial drugs or quinolone antibacterial drugs.
[0012] The technical effects and advantages of this invention are as follows: 1. This invention uses a compound system of carboxylate-type glutamic acid surfactant and sulfonate-type amphoteric surfactant, combined with a multi-level pH buffer system to precisely control the product pH at 3.8~4.5. At the same time, it introduces multi-dimensional synergistic regulatory components of short-chain prebiotics, long-chain prebiotics and post-biotic metabolites, which can maintain a weakly acidic environment in the intimate area while effectively cleaning, promoting the proliferation of vaginal symbiotic lactobacilli and inhibiting the excessive reproduction of opportunistic pathogens, thus solving the technical problems of traditional care solutions that make the area drier and itchier with each wash. 2. This invention enhances the expression of tight junction proteins in mucosal epithelium by using a composite liposome of sodium hyaluronate with gradient molecular weight and ceramide NP phospholipids to repair the physical barrier. At the same time, it synergistically induces vaginal epithelial cells to secrete antimicrobial peptide hBD-2 by a combination of yeast β-glucan with specific molecular weight and branching degree, Tremella fuciformis polysaccharide with specific degree of acetylation and Lactobacillus johnsonii postbiotic, thereby activating the immune barrier and achieving a technological upgrade from passive repair to active defense. 3. This application uses a complex polysaccharide interpenetrating network gel matrix and naturally derived alginate oligosaccharides to form a pH-responsive intelligent delivery system. Under normal pH conditions, it maintains a low-viscosity liquid state for easy cleaning, and when the pH increases, it quickly forms a high-viscosity gel layer to prolong the residence time of active ingredients. At the same time, the use of cold mixing process and recyclable packaging significantly reduces production energy consumption and conforms to the green manufacturing orientation. Attached Figure Description
[0013] Figure 1 This is a flowchart illustrating the preparation process of the composition of the present invention. Detailed Implementation
[0014] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.
[0015] This embodiment provides a composition for maintaining the microecological barrier of intimate care. The composition includes a microecological balance regulating component, a multi-target repair component for the mucosal barrier, and a pH-responsive intelligent delivery system.
[0016] The microecological balance regulating components include a low-irritant surfactant compound system, a multi-level pH buffer system, and a multi-dimensional prebiotic-postbiotic synergistic regulatory component: The low-irritant surfactant compound system is composed of a carboxylate-type glutamate surfactant and a sulfonate-type amphoteric surfactant in a mass ratio of 1.5~3:1~2, with a total concentration of 6~12% by weight. The carboxylate-type glutamate surfactant is selected from sodium lauroyl glutamate, disodium cocoyl glutamate or a combination thereof, and the sulfonate-type amphoteric surfactant is a mixture of lauramidopropyl hydroxysulfonate betaine and cocamidopropyl betaine in a mass ratio of 1:1. The multi-stage pH buffer system consists of a lactic acid / sodium lactate main buffer pair, a citric acid / sodium citrate auxiliary buffer pair, and a potassium dihydrogen phosphate / dipoxetine hydrogen phosphate third buffer pair. The molar ratio of lactic acid to sodium lactate is 1:0.8~1.2, the molar ratio of citric acid to sodium citrate is 1:0.5~2.0, and the total molar amount of potassium dihydrogen phosphate and diipoxetine hydrogen phosphate is 0.2~0.5 times the total molar amount of the main buffer pair. The multidimensional prebiotic-metabolic synergistic regulatory component includes short-chain prebiotics, long-chain prebiotics, and metabolites. The short-chain prebiotics are a combination of fructooligosaccharides and galactooligosaccharides, with a total content of 0.5-2% by weight. The long-chain prebiotics are a combination of inulin and α-glucan oligosaccharides, with a total content of 0.3-1.5% by weight. The metabolites include 0.1-0.5% by weight of Lactobacillus fermentation lysate and 0.2-0.8% by weight of Lactobacillus fermentation metabolite composition.
[0017] The multi-target mucosal barrier repair component includes an antioxidant-anti-inflammatory synergistic system, a tight junction protein expression-enhancing component, and an antimicrobial peptide expression-inducing component: The antioxidant-anti-inflammatory synergistic system is composed of bisabolol, dipotassium glycyrrhizate, scutellaria baicalensis root extract, gentian root extract, and asiaticoside compound in a mass ratio of 2~5:1~3:0.5~2:1~2:1~3, with a total content of 0.5~3% by weight. The tight junction protein expression-enhancing component comprises graded molecular weight sodium hyaluronate and ceramide NP phospholipid complex liposomes. The graded molecular weight sodium hyaluronate is composed of ultra-high molecular weight sodium hyaluronate, high molecular weight sodium hyaluronate, low molecular weight sodium hyaluronate, and oligomeric sodium hyaluronate in a mass ratio of 0.5–2:1–3:2–5:1–2, with a total content of 0.2–1% by weight. Specifically, the ultra-high molecular weight sodium hyaluronate has a molecular weight of 1.2–1.8 MDa, the high molecular weight sodium hyaluronate has a molecular weight of 0.8–1.2 MDa, the low molecular weight sodium hyaluronate has a molecular weight of 8–50 kDa, and the oligomeric sodium hyaluronate has a molecular weight ≤10 kDa. The ceramide NP phospholipid complex liposomes are prepared by mixing ceramide NP and hydrogenated lecithin in a mass ratio of 1:2–4, with a particle size of 80–150 nm and a content of 0.1–1% by weight. The antimicrobial peptide expression inducing component comprises yeast β-glucan, Tremella fuciformis polysaccharide, and a postbiotic composition of Lactobacillus johnsonii. The yeast β-glucan has a molecular weight of 50-200 kDa, a β-1,6 branching degree ≥30%, and a content of 0.2-1% by weight. The Tremella fuciformis polysaccharide has a degree of acetylation of 0.3-0.6, a molecular weight of 500-1500 kDa, and a content of 0.1-0.5% by weight. The Lactobacillus johnsonii postbiotic composition comprises heat-inactivated Lactobacillus johnsonii cells, cell wall components, and fermentation metabolites, with a content of 0.2-1% by weight. This Lactobacillus johnsonii postbiotic composition is prepared by the following method: Lactobacillus johnsonii is inoculated into MRS medium and cultured at 37°C for 24 h. The cells are collected, inactivated by heat treatment at 80°C for 30 min, and the cells and supernatant are collected by centrifugation, mixed, and freeze-dried to obtain the final product.
[0018] The pH-responsive smart delivery system comprises a complex polysaccharide interpenetrating network gel matrix and a naturally derived pH-responsive osmotic pressure regulator: The complex polysaccharide interpenetrating network gel matrix is composed of carrageenan, pectin, sodium alginate, hydroxypropyl methylcellulose, and sodium carboxymethyl cellulose. Carrageenan is a mixture of κ-type and ι-type carrageenan in a mass ratio of 2:1 to 1:2, with a total content of 0.3 to 1 wt%. Pectin has a degree of esterification of 25 to 35% and a content of 0.2 to 0.8 wt%. Sodium alginate has a guluronic acid to mannulic acid molar ratio of 0.5 to 1.5, a molecular weight of 80 to 400 kDa, and a content of 0.3 to 1 wt%. Hydroxypropyl methylcellulose has a methoxy group content of 28 to 30% and a hydroxypropoxy group content of 7 to 12%, with a content of 0.1 to 0.5 wt%. Sodium carboxymethyl cellulose has a degree of substitution of 0.7 to 0.9 and a content of 0.1 to 0.5 wt%. The naturally derived pH-responsive osmotic pressure regulator is a low molecular weight alginate oligosaccharide with a molecular weight of 3-10 kDa, a degree of polymerization of 20-60, and a content of 0.2-1% by weight.
[0019] As attached Figure 1 As shown, the preparation method of the composition of the present invention is as follows: The compositions of the present invention in the following examples were prepared according to the following steps: S1. Under conditions of ≤40℃, the low-irritant surfactant compound system is mixed with purified water and stirred at 200~400rpm until completely dissolved to obtain phase A; S2. Under conditions of ≤40℃, the multi-stage pH buffer system is dissolved in purified water to obtain a buffer solution. The multi-dimensional prebiotic-postbiotic synergistic regulatory components are added to phase A and stirred at 150~300rpm for 20~40min. The pH is adjusted to 3.8~4.5 with the above buffer solution to obtain phase B. S3. Under conditions of ≤35℃, pre-disperse the complex polysaccharide interpenetrating network gel matrix and the natural pH-responsive osmotic pressure regulator in glycerol or 1,3-propanediol. The amount of 1,3-propanediol is 0.5 to 2 times the total weight of the complex polysaccharide interpenetrating network gel matrix and the natural pH-responsive osmotic pressure regulator. Slowly add it to phase B at 400 to 600 rpm and continue stirring for 40 to 90 min until complete hydration to form a homogeneous gel system. S4. Under conditions of ≤30℃, add the multi-target repair components of the mucosal barrier to the gel system in sequence and stir at 200~300rpm for 20~40min. S5. The mixture obtained in step S4 is subjected to high-pressure homogenization at 15~30MPa 2~4 times to make the particle size D90≤800nm (measured by dynamic light scattering particle size analyzer). S6. Fill the product into recyclable packaging containers under aseptic conditions to obtain the finished product.
[0020] Example 1 Weigh each component according to the following amounts, based on the total weight of the composition as 100%: Low-irritant surfactant compound system: a mixture of sodium lauroyl glutamate, lauramidopropyl hydroxysulfonate, and cocamidopropyl betaine, in a mass ratio of 6:3:3, with a total concentration of 8% by weight. Multi-stage pH buffer system: lactic acid to sodium lactate molar ratio 1:1, citric acid to sodium citrate molar ratio 1:1, potassium dihydrogen phosphate and dipotassium hydrogen phosphate total molar amount of the main buffer is 0.3 times the total molar amount; Multi-dimensional prebiotic-metabolic synergistic regulatory components: fructooligosaccharides 0.6 wt%, galactooligosaccharides 0.4 wt%, inulin 0.3 wt%, α-glucan oligosaccharides 0.2 wt%, Lactobacillus fermentation lysate 0.3 wt%, Lactobacillus fermentation metabolite composition 0.5 wt%; Antioxidant-anti-inflammatory synergistic system: bisabolol 0.2 wt%, dipotassium glycyrrhizate 0.1 wt%, scutellaria baicalensis root extract 0.1 wt%, gentian scabra root extract 0.1 wt%, asiaticoside complex 0.2 wt%; Tight junction protein expression enhancement components: 0.05 wt% ultra-high molecular weight sodium hyaluronate, 0.1 wt% high molecular weight sodium hyaluronate, 0.2 wt% low molecular weight sodium hyaluronate, 0.05 wt% oligomeric sodium hyaluronate; 0.3 wt% ceramide NP phospholipid complex liposomes; Antimicrobial peptide expression inducing components: yeast β-glucan (molecular weight 100kDa, branching degree 35%) 0.4 wt%, Tremella fuciformis polysaccharide (degree of acetylation 0.5, molecular weight 1000kDa) 0.2 wt%, Lactobacillus johnsonii postbiotic composition 0.5 wt%; pH-responsive intelligent delivery system: 0.5 wt% of a mixture of κ- and ι-carrageenan (1:1 mass ratio), 0.4 wt% of pectin, 0.5 wt% of sodium alginate, 0.2 wt% of hydroxypropyl methylcellulose, and 0.2 wt% of sodium carboxymethyl cellulose; 0.3 wt% of low molecular weight alginate oligosaccharide (5 kDa, degree of polymerization 30). The remainder is purified water.
[0021] The composition sample was prepared according to the above preparation method.
[0022] Example 2 The difference between this embodiment and Example 1 is as follows: the total concentration of the low-irritant surfactant compound system is adjusted to 10% by weight, and the mass ratio of sodium lauroyl glutamate to sulfonate-type amphoteric surfactant is 2:1; the yeast β-glucan content in the antimicrobial peptide expression inducing component is adjusted to 0.6% by weight, the Tremella fuciformis polysaccharide content is adjusted to 0.3% by weight, and the Lactobacillus johnsonii postbiotic composition content is adjusted to 0.8% by weight; other components and preparation methods are the same as in Example 1.
[0023] Example 3 The difference between this embodiment and Example 1 is that: in the multi-stage pH buffer system, the molar ratio of lactic acid to sodium lactate is adjusted to 1:1.2, and the molar ratio of citric acid to sodium citrate is adjusted to 1:1.5; in the pH-responsive smart delivery system, the mass ratio of κ-type to ι-type carrageenan is adjusted to 2:1; other components and preparation methods are the same as in Example 1.
[0024] Comparative Example 1 The difference between this comparative example and Example 1 is that the antimicrobial peptide expression-inducing component was not added (i.e., yeast β-glucan, Tremella fuciformis polysaccharide, and Lactobacillus johnsonii postbiotic composition were not added), and the missing components were made up to 100% with purified water. Other components and preparation methods are the same as in Example 1.
[0025] Comparative Example 2 The difference between this comparative example and Example 1 is that no naturally derived pH-responsive osmotic pressure regulator (i.e., no low molecular weight alginate oligosaccharide) is added, and the missing components are replenished to 100% with purified water. Other components and preparation methods are the same as in Example 1.
[0026] The performance of Examples 1-3 and Comparative Examples 1-2 will be tested below, and the testing methods are as follows: pH response behavior test: Take the compositions prepared in each example and comparative example, measure the initial pH value with a pH meter, and adjust to pH 5.0, 5.5 and 6.0 respectively with 0.1 mol / L sodium hydroxide solution. Use a rotational viscometer (Brookfield DV2T, rotor S64, rotation speed 20 rpm, 25℃) to measure the viscosity under each pH condition. Antimicrobial peptide expression induction effect test: Using a 3D vaginal epithelial model (EpiVaginal tissue model), the compositions of each example and comparative example were treated with the model at a non-stimulating concentration (0.1%) for 24 h. Total RNA was extracted, and the mRNA expression level of human β-defensin-2 (hBD-2) was detected by qRT-PCR. At the same time, the culture supernatant was collected, and the hBD-2 protein secretion was detected by ELISA kit. The Kirby-Bauer disk diffusion method was used to detect the antibacterial activity of the composition against Escherichia coli, Candida albicans and vaginal commensal lactobacilli. The bacterial solution was evenly spread on the surface of a solid culture medium, a sterile filter paper with a diameter of 6 mm was placed on it, 20 μL of the original composition solution was added, and the mixture was incubated at 37°C for 24 h. The diameter of the inhibition zone was then measured. Barrier repair effect test: A 3D vaginal epithelial model was used. The compositions of each example and comparative example were treated with the model at a non-irritating concentration for 24 hours. Then, the transepidermal water loss (TEWL) value was measured using Tewameter®, and proteins were extracted. The expression levels of tight junction proteins Claudin-1, Occludin, and filaggrin were detected by Western blot. The improvement rate was calculated with the negative control group as the benchmark. Safety testing: Chicken embryo chorioallantoic membrane test was conducted in accordance with the "Cosmetic Safety Technical Specifications". 0.3 mL of the original solution of each example and comparative example was directly added to the chicken embryo chorioallantoic membrane. After 30 seconds of action, the vascular damage was observed and scored on a scale of 0-5. A repeatable patch test was conducted on human subjects in accordance with the "Cosmetic Safety Technical Specifications". Thirty healthy subjects were recruited, and the composition was applied to the back skin. Skin reactions were observed after 48 hours. The results showed that all samples had negative patch test results and no adverse skin reactions.
[0027] The final test data is shown in the table below: The data in the table above shows that: 1. The key role of antimicrobial peptide expression inducing components In Comparative Example 1, due to the lack of antimicrobial peptide expression-inducing components (yeast β-glucan, Tremella fuciformis polysaccharide, and Lactobacillus johnsonii postbiotic combination), the hBD-2 mRNA expression fold was only 1.2, and the protein secretion increase fold was only 0.9, far lower than Examples 1-3 (mRNA increase of 3.8-4.5 times, protein secretion increase of 2.3-2.8 times). At the same time, the diameter of the inhibition zone against Escherichia coli and Candida albicans decreased significantly (from 15 mm to 8 mm and from 12 mm to 6 mm, respectively), while there was still no inhibition against Lactobacillus. This indicates that the antimicrobial peptide expression-inducing components are the core of the active strengthening of the immune barrier in this invention, and their absence will lead to a significant weakening of the antimicrobial peptide secretion capacity and selective antibacterial effect. 2. The key role of pH-responsive osmotic pressure regulators Comparative Example 2, lacking low-molecular-weight alginate oligosaccharides, exhibited a viscosity of only 2800 mPa·s at pH 5.0, failing to form an effective high-viscosity gel layer (Example 1 had a viscosity of 9500 mPa·s under the same conditions). At pH 5.5 and pH 6.0, the viscosities of Comparative Example 2 were 3100 mPa·s and 3200 mPa·s, respectively, still significantly lower than the 12000 mPa·s and 11800 mPa·s of Example 1. This indicates that alginate oligosaccharides, through their carboxyl protonation / deprotonation effects, synergistically regulate osmotic pressure and are a necessary component for rapid gelation in pH-responsive intelligent delivery systems. Notably, the hBD-2 mRNA expression fold of Comparative Example 2 was 3.5-fold, slightly lower than the 4.2-fold of Example 1, but still significantly higher than the 1.2-fold of Comparative Example 1. This suggests that alginate oligosaccharides have no direct effect on antimicrobial peptide expression; their role is mainly concentrated in pH-responsive osmotic pressure regulation. 3. Synergistic effect of each component Examples 1-3 were significantly better than Comparative Examples 1 and 2 in all test indicators. Example 2 optimized the surfactant concentration and the content of antimicrobial peptide inducing components based on Example 1, resulting in better effects. Example 3 adjusted the pH buffer ratio and carrageenan ratio, and the effect was slightly lower than that of Examples 1-2 but still much better than the comparative examples. This shows that there is a synergistic effect among the components of the composition of the present invention, which together achieve the comprehensive effects of microecological balance regulation, multi-target repair of mucosal barrier and pH-responsive intelligent delivery. 4. Safety All examples and comparative examples passed human patch tests, and the chicken embryo test stimulation scores were all ≤0.8, indicating that the compositions of the present invention are safe and non-irritating and can be applied to intimate care areas.
[0028] In summary: The composition provided by this invention achieves the unity of cleansing and microecological protection, dual repair of physical and immune barriers, and precise pH-responsive delivery through the synergistic effect of microecological balance regulating components, multi-target repair components for mucosal barriers, and pH-responsive intelligent delivery system. It overcomes the technical bottlenecks of existing intimate care solutions. The test results of Examples 1-3 prove that the technical solution of this invention has significant technical effects, and Comparative Examples 1-2 further prove the necessity and synergistic effect of key components.
[0029] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.
Claims
1. A composition for maintaining a microecological barrier in intimate care, characterized in that: The composition comprises: Microecological balance regulating components, wherein the microecological balance regulating components include: A low-irritant surfactant compound system, wherein the low-irritant surfactant compound system is composed of a carboxylate-type glutamate surfactant and a sulfonate-type amphoteric surfactant in a mass ratio of 1.5~3:1~2, with a total concentration of 6~12% by weight. A multi-stage pH buffer system, comprising a lactic acid / sodium lactate primary buffer pair, a citric acid / sodium citrate secondary buffer pair, and a potassium dihydrogen phosphate / dipoxetine hydrogen phosphate tertiary buffer pair, wherein the molar ratio of lactic acid to sodium lactate is 1:0.8~1.2, the molar ratio of citric acid to sodium citrate is 1:0.5~2.0, and the total molar amount of potassium dihydrogen phosphate and diipoxetine hydrogen phosphate is 0.2~0.5 times the total molar amount of the primary buffer pair; A multidimensional prebiotic-metasecemic synergistic regulatory component, comprising short-chain prebiotics, long-chain prebiotics, and metabolites, wherein the short-chain prebiotics are a combination of fructooligosaccharides and galactooligosaccharides, with a total content of 0.5-2% by weight; the long-chain prebiotics are a combination of inulin and α-glucan oligosaccharides, with a total content of 0.3-1.5% by weight; and the metabolites comprise 0.1-0.5% by weight of Lactobacillus fermentation lysate and 0.2-0.8% by weight of a Lactobacillus fermentation metabolite composition. A multi-target mucosal barrier repair component, comprising: An antioxidant-anti-inflammatory synergistic system, wherein the antioxidant-anti-inflammatory synergistic system is composed of bisabolol, dipotassium glycyrrhizate, scutellaria baicalensis root extract, gentian root extract and asiaticoside composition in a mass ratio of 2~5:1~3:0.5~2:1~2:1~3, with a total content of 0.5~3% by weight. The tight junction protein expression-enhancing component comprises graded molecular weight sodium hyaluronate and ceramide NP phospholipid complex liposomes. The graded molecular weight sodium hyaluronate is composed of ultra-high molecular weight sodium hyaluronate, high molecular weight sodium hyaluronate, low molecular weight sodium hyaluronate, and oligomeric sodium hyaluronate in a mass ratio of 0.5~2:1~3:2~5:1~2, with a total content of 0.2~1% by weight. The ceramide NP phospholipid complex liposomes are prepared by mixing ceramide NP and hydrogenated lecithin in a mass ratio of 1:2~4, with a particle size of 80~150 nm and a content of 0.1~1% by weight. The antimicrobial peptide expression inducing component comprises yeast β-glucan, Tremella fuciformis polysaccharide, and a postbiotic composition of Lactobacillus johnsonii. The yeast β-glucan has a molecular weight of 50-200 kDa, a β-1,6 branching degree ≥30%, and a content of 0.2-1% by weight. The Tremella fuciformis polysaccharide has a degree of acetylation of 0.3-0.6, a molecular weight of 500-1500 kDa, and a content of 0.1-0.5% by weight. The Lactobacillus johnsonii postbiotic composition comprises heat-inactivated Lactobacillus johnsonii cells, cell wall components, and fermentation metabolites, with a content of 0.2-1% by weight. A pH-responsive smart delivery system, comprising: A composite polysaccharide interpenetrating network gel matrix is composed of carrageenan, pectin, sodium alginate, hydroxypropyl methylcellulose, and sodium carboxymethyl cellulose. Specifically, the carrageenan is a mixture of κ-type and ι-type carrageenan in a mass ratio of 2:1 to 1:2, with a total content of 0.3 to 1 wt%; the pectin has a degree of esterification of 25 to 35% and a content of 0.2 to 0.8 wt%; the sodium alginate has a guluronic acid to mannulic acid molar ratio of 0.5 to 1.5, a molecular weight of 80 to 400 kDa, and a content of 0.3 to 1 wt%; the hydroxypropyl methylcellulose has a methoxy group content of 28 to 30% and a hydroxypropoxy group content of 7 to 12%, with a content of 0.1 to 0.5 wt%; and the sodium carboxymethyl cellulose has a degree of substitution of 0.7 to 0.9 and a content of 0.1 to 0.5 wt%. A naturally derived pH-responsive osmotic pressure regulator, wherein the naturally derived pH-responsive osmotic pressure regulator is a low molecular weight alginate oligosaccharide with a molecular weight of 3~10kDa, a degree of polymerization of 20~60, and a content of 0.2~1% by weight.
2. The composition according to claim 1, characterized in that: The carboxylate-type glutamate surfactant is selected from sodium lauroyl glutamate, disodium cocoyl glutamate, or a combination thereof, and the sulfonate-type amphoteric surfactant is a mixture of lauramidopropyl hydroxysulfonate betaine and cocamidopropyl betaine in a mass ratio of 1:
1.
3. The composition according to claim 1, characterized in that: Among the graded molecular weight sodium hyaluronates, the ultra-high molecular weight sodium hyaluronate has a molecular weight of 1.2~1.8 MDa, the high molecular weight sodium hyaluronate has a molecular weight of 0.8~1.2 MDa, the low molecular weight sodium hyaluronate has a molecular weight of 8~50 kDa, and the oligomeric sodium hyaluronate has a molecular weight ≤10 kDa.
4. A method for balancing and regulating, based on the composition for maintaining the microecological barrier of intimate care as described in any one of claims 1-3, characterized in that: The method includes: applying the composition to the intimate care area by rinsing; the composition remains in a liquid state at a pH of 3.8 to 4.5; and when the pH increases to ≥5.0, the composition forms a high-viscosity gel layer.
5. The method according to claim 4, characterized in that: The composition is prepared by the following steps: S1. Under conditions of ≤40℃, the low-irritant surfactant compound system is mixed with purified water and stirred until dissolved to obtain phase A; S2. Under conditions of ≤40℃, the multi-stage pH buffer system is dissolved in purified water to obtain a buffer solution. The multi-dimensional prebiotic-postbiotic synergistic regulatory components are added to phase A, stirred for 20~40min, and the pH is adjusted to 3.8~4.5 with the buffer solution to obtain phase B. S3. Under conditions of ≤35℃, the complex polysaccharide interpenetrating network gel matrix and the natural pH-responsive osmotic pressure regulator are pre-dispersed in glycerol or 1,3-propanediol, added to phase B at 400~600rpm, and stirred for 40~90min until completely hydrated; S4. Under conditions of ≤30℃, add the multi-target repair components of the mucosal barrier to the above gel system in sequence and stir for 20~40min; S5. The mixture obtained in step S4 is homogenized under high pressure at 15~30MPa 2~4 times to make the particle size D90≤800nm; S6. Aseptic filling.
6. The use of the composition according to any one of claims 1-3 in the preparation of cosmetics for maintaining the microecological barrier of intimate care areas, characterized in that: The cosmetic product is a rinse-type vulvar care solution with a pH value of 3.8-4.5, and does not contain any chemically synthesized antibiotics, sulfonamide antibacterial drugs, or quinolone antibacterial drugs.
Citation Information
Patent Citations
Environment-friendly nutritional type female private part care solution
CN105663001A