Medical beauty-grade sensitive skin repair dressing with gamma-polyglutamic acid controlled release function
By modifying γ-polyglutamic acid to prepare controlled-release microspheres and combining them with biocompatible wall materials, precise controlled release and multiple repair effects of γ-polyglutamic acid can be achieved. This solves the problems of easy loss of γ-polyglutamic acid, low utilization rate of active ingredients and poor carrier compatibility, and is suitable for wound care after medical aesthetics and sensitive skin care.
Patent Information
- Application Number
- CN202610029666.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-01-10
- Publication Date
- 2026-02-24
AI Technical Summary
In existing medical aesthetic repair dressings, γ-polyglutamic acid has poor stability and is easily lost, has low utilization rate of active ingredients, poor carrier biocompatibility, and complex controlled release technology with release rate that is difficult to match the physiological rhythm of skin repair, resulting in poor repair effect.
Controlled-release microspheres were prepared by modifying γ-polyglutamic acid, combined with biocompatible polymer wall materials, and designed with a 12-72h gradient release. With the addition of moisturizing and anti-inflammatory ingredients, a multifunctional matrix was formed to achieve precise controlled release and multiple repair effects.
It improves the stability and utilization rate of active ingredients of γ-polyglutamic acid, prolongs the action period, enhances biocompatibility, is suitable for fragile wounds and sensitive skin, has multiple effects such as moisturizing and anti-inflammation, has a wide range of applications, low cost and is suitable for large-scale production.
Smart Images
Figure CN121550477A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of biomedical materials technology, and more specifically, it relates to a medical-grade sensitive skin repair dressing with γ-polyglutamic acid controlled release function. Background Technology
[0002] With the rapid development of the medical aesthetics industry, the demand for post-medical aesthetic wound repair and sensitive skin care is increasing. Medical aesthetic procedures (such as laser treatments, IPL skin rejuvenation, and microneedling) can cause varying degrees of micro-injury to the skin, damaging the skin barrier and leading to problems such as redness, swelling, pain, dryness, and sensitivity. People with sensitive skin, due to their weakened skin barrier function, are easily irritated by external stimuli, triggering inflammatory reactions. Therefore, developing medical-grade repair dressings that combine repair, moisturizing, anti-inflammatory, and gentle, non-irritating properties has become a research hotspot.
[0003] Gamma-polyglutamic acid (γ-PGA) is a natural, water-soluble polymer with excellent moisturizing properties, biocompatibility, and biodegradability, showing great potential in the field of skin repair. However, natural γ-PGA has drawbacks such as poor stability, rapid loss from the skin surface, and short duration of action, making it difficult to fully realize its repair efficacy. Most existing medical aesthetic repair dressings directly add natural γ-PGA and other active ingredients without modifying the γ-PGA or using a controlled-release microsphere structure of 'modified core material + biocompatible wall material'. This results in rapid loss of active ingredients from the skin surface, with a loss rate exceeding 60% within 24 hours and an active ingredient utilization rate of less than 30%, maintaining the repair effect for only 4-8 hours. Furthermore, some dressings use carrier materials (such as synthetic resins) with poor biocompatibility, resulting in skin irritation scores ≥5 out of 10, making them unsuitable for fragile wounds and sensitive skin environments after medical aesthetic procedures.
[0004] Furthermore, existing controlled-release technologies for use in medical aesthetic dressings still have limitations: some controlled-release carriers have complex preparation processes and high costs, making them unsuitable for large-scale production; the release rates of some controlled-release systems are difficult to match the physiological rhythm of skin repair, failing to achieve precise and long-lasting supply of active ingredients. Therefore, developing a medical aesthetic-grade sensitive skin repair dressing with a simple preparation process, controllable cost, precise controlled release of γ-polyglutamic acid, and multiple repair effects is of great significance for improving the effectiveness of medical aesthetic repair and enhancing the sensitive skin care experience. Summary of the Invention
[0005] To address the aforementioned technical challenges, this invention provides a medical-grade sensitive skin repair dressing with γ-polyglutamic acid controlled-release function through a combined technical solution of "γ-polyglutamic acid modification to enhance stability + biocompatible wall material encapsulation to construct controlled-release microspheres + synergistic formulation of multi-functional matrix". Specifically, acylation / grafting modification reduces the water solubility of γ-polyglutamic acid, minimizing its loss; a specific core-wall material ratio and particle size design achieves a gradient release over 12-72 hours; and the precise formulation of moisturizing and anti-inflammatory components in the matrix synergistically enhances the repair effect. Ultimately, this invention solves the technical problems of existing medical-grade repair dressings, such as rapid loss of γ-polyglutamic acid, short action period, low utilization rate of active ingredients, poor carrier biocompatibility, single function, complex controlled-release technology, and difficulty in matching the release rate with the skin repair rhythm.
[0006] A medical-grade sensitive skin repair dressing with γ-polyglutamic acid controlled-release function includes controlled-release microspheres and a matrix material, wherein the controlled-release microspheres are dispersed in the matrix material;
[0007] The controlled-release microspheres are composed of an active core material and a wall material. The active core material is modified γ-polyglutamic acid, and the wall material is a biocompatible polymer material.
[0008] The matrix material includes a medical-grade gel matrix, moisturizing ingredients, and anti-inflammatory and soothing ingredients;
[0009] The repair dressing achieves gradient release of γ-polyglutamic acid through controlled-release microspheres, with a release cycle of 12-72 hours.
[0010] Preferably, in the controlled-release microspheres, the mass ratio of the active core material to the wall material is 1:2-1:8; and the particle size of the controlled-release microspheres is 100-500 nm.
[0011] Preferably, the modified γ-polyglutamic acid is a derivative obtained by acylation modification or graft modification, with a modification degree of 15%-40%;
[0012] The acylation reagent used in the acylation modification is a fatty acyl chloride or an acid anhydride, and the grafting monomer used in the grafting modification is acrylamide or polyethylene glycol monomethyl ether methacrylate.
[0013] Preferably, the wall material is selected from at least one of polylactic acid-glycolic acid copolymer, chitosan, sodium alginate, and gelatin;
[0014] When the wall material is a polylactic acid-glycolic acid copolymer, the molar ratio of lactic acid to glycolic acid is 3:7-7:3.
[0015] Preferably, the medical-grade gel matrix is selected from at least one of sodium hyaluronate, sodium carboxymethyl cellulose, and polyacrylamide, and its mass fraction in the matrix material is 5%-15%.
[0016] The moisturizing ingredient is selected from at least one of glycerin, betaine, and panthenol, with a mass fraction of 3%-8%;
[0017] The anti-inflammatory and soothing ingredient is selected from at least one of dipotassium glycyrrhizate, bisabolol, and ceramide, with a mass fraction of 0.5%-3%.
[0018] Preferably, the controlled-release microspheres are prepared by an emulsification-crosslinking method or a solvent evaporation method, specifically including the following steps:
[0019] The modified γ-polyglutamic acid was dissolved in an aqueous solvent to obtain a core material solution;
[0020] The wall material is dissolved in an organic solvent to obtain a wall material solution;
[0021] The core material solution is added to the wall material solution, and emulsified by high-speed stirring under the action of an emulsifier to form an emulsion;
[0022] By adding a crosslinking agent or evaporating the solvent, controlled-release microspheres are obtained through curing.
[0023] Wash and dry before use.
[0024] Preferably, the stirring speed during the emulsification process is 8000-15000 r / min, and the emulsification time is 10-30 min;
[0025] The crosslinking agent is glutaraldehyde or genipin, and the amount added is 1%-5% of the wall material weight.
[0026] The solvent has an evaporation temperature of 30-50℃ and an evaporation time of 2-6 hours.
[0027] Preferably, the method for preparing the repair dressing includes:
[0028] The medical-grade gel matrix was added to deionized water, heated to dissolve, and stirred until homogeneous to obtain a matrix solution.
[0029] Add moisturizing and anti-inflammatory soothing ingredients to the base solution and continue stirring until completely dissolved;
[0030] The controlled-release microspheres were added to the above solution, ultrasonically dispersed until uniform, degassed, filled, and sterilized to obtain the finished product.
[0031] Preferably, the repair dressing has a moisture content of 60%-85%, a pH value of 5.5-7.0, a tensile strength ≥0.5MPa, and an air permeability ≥100g / (m²·24h);
[0032] In simulated skin conditions, the cumulative release of γ-polyglutamic acid was 30%-50% in 24 hours, 60%-80% in 48 hours, and ≥90% in 72 hours.
[0033] Preferably, the repair dressing is a gel dressing, a film dressing, or a spray dressing, used for wound repair or sensitive skin barrier reconstruction after medical aesthetic procedures. It can reduce wound inflammation, promote epidermal cell proliferation, and increase the moisture content of the stratum corneum and the transdermal water loss barrier function.
[0034] Compared with the prior art, the present invention has the following beneficial effects:
[0035] Achieving precise controlled release of γ-polyglutamic acid and enhancing efficacy sustainability: This invention modifies γ-polyglutamic acid and uses biocompatible wall materials to prepare controlled-release microspheres, which can precisely control the release rate of γ-polyglutamic acid, achieving a gradient release from 12 to 72 hours (30%-50% cumulative release at 24 hours, 60%-80% at 48 hours, and ≥95% at 72 hours). Compared with natural γ-polyglutamic acid (loss rate exceeding 60% at 24 hours), the utilization rate of active ingredients is increased from less than 30% to over 85%, and the action period is extended from 4-8 hours to 72 hours, significantly improving the sustainability and stability of the repair efficacy and solving the problems of low utilization rate of active ingredients and short action period of existing products.
[0036] Modification treatment enhances biocompatibility and efficacy: This invention acylates or grafts γ-polyglutamic acid, which not only improves its own stability but also enhances its compatibility with skin tissue, reducing the risk of irritation to sensitive skin and postoperative wounds. At the same time, the modified γ-polyglutamic acid works synergistically with the moisturizing and anti-inflammatory components in the matrix to further enhance the repair effect of the dressing, making it suitable for fragile medical aesthetic wounds and sensitive skin environments.
[0037] Synergistic effects to meet complex repair needs: This invention uses a scientific ratio of TCM-grade gel matrix, moisturizing ingredients (glycerin, betaine, etc.), and anti-inflammatory and soothing ingredients (dipotassium glycyrrhizate, bisabolol, etc.) to make the dressing have multiple effects such as moisturizing and water-locking, anti-inflammatory and analgesic, and soothing and calming. It can simultaneously solve problems such as redness, swelling, pain, dryness and itching and redness of sensitive skin after medical aesthetics, and comprehensively cover the complex needs of medical aesthetic repair and sensitive skin care.
[0038] The preparation process is simple and controllable, and suitable for large-scale production: The modification process, controlled-release microsphere preparation process (emulsification-crosslinking method, solvent evaporation method) and dressing preparation process adopted in this invention are all characterized by simple operation, easy parameter control and low cost. No special high-end equipment is required, and large-scale industrial production can be realized, which is conducive to reducing product costs and increasing market penetration.
[0039] With diverse dosage forms to suit different usage scenarios, this invention can be prepared into various dosage forms such as gel, film, and spray according to actual needs. The gel formulation has good adhesion to the wound and is suitable for localized key repair; the film formulation is convenient to use and can quickly cover the wound to form a protective barrier; the spray formulation is easy to spray over a large area and is suitable for dispersed wounds and daily sensitive skin care, significantly improving the product's applicability and usage flexibility.
[0040] Medical-grade safety standards, controllable risks: The raw materials used in this invention are all medical-grade materials, which meet the safety requirements of medical aesthetic products; the product is sterilized through medical-grade sterilization processes such as moist heat sterilization, ethylene oxide sterilization, and irradiation sterilization to ensure sterility; the product's pH value is controlled within a skin-friendly range of 5.5-7.0, and its moisture content, tensile strength, breathability, and other properties all meet medical dressing standards, ensuring high safety and no obvious toxic side effects. Attached Figure Description
[0041] Figure 1 This is a schematic diagram of the structure of the present invention. Detailed Implementation
[0042] The embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and should not be construed as limiting the scope of the invention.
[0043] Please see Figure 1 This invention provides a medical-grade sensitive skin repair dressing with controlled-release γ-polyglutamic acid function. The invention will be further described in detail below with reference to specific embodiments. It should be noted that the following embodiments are only used to illustrate the technical solution of this invention and are not intended to limit the scope of protection of this invention. Conventional adjustments made by those skilled in the art to the types of raw materials, parameter values, etc., within the scope defined by the claims of this invention, are all within the scope of protection of this invention.
[0044] The modification degree test method of the modified γ-polyglutamic acid described in this invention adopts potentiometric titration. The modification degree is calculated by measuring the change in carboxyl content in γ-polyglutamic acid before and after modification. Modification degree = (Carboxyl content before modification - Remaining carboxyl content after modification) / Carboxyl content before modification × 100%.
[0045] The method for testing the particle size of the controlled-release microspheres described in this invention is as follows: The controlled-release microspheres are dispersed in deionized water using a dynamic light scattering instrument (DLS), and tested after ultrasonic dispersion for 5 minutes. Each sample is tested 3 times, and the average value is taken.
[0046] The method for testing the cumulative release of γ-polyglutamic acid described in this invention is as follows: An in vitro release experiment was conducted using a simulated skin environment (PBS buffer, pH=5.5, temperature 37℃). 1g of repair dressing was placed in a dialysis bag and immersed in 50mL of PBS buffer. The mixture was kept at a constant temperature and shaken (100r / min). 5mL samples were taken at set time points, and an equal amount of fresh PBS buffer was added. The content of γ-polyglutamic acid in the sample was determined by high performance liquid chromatography (HPLC), and the cumulative release was calculated.
[0047] Example 1: Acylated modified γ-polyglutamic acid + chitosan wall material controlled-release microsphere gel dressing
[0048] Step 1: Preparation of acylated modified γ-polyglutamic acid (active core material):
[0049] Take 10g of γ-polyglutamic acid (molecular weight 100kDa) and dissolve it in 200mL of deionized water. Stir until completely dissolved to obtain an aqueous solution of γ-polyglutamic acid.
[0050] Dissolve 5g of lauroyl chloride (acylation reagent) in 50mL of anhydrous ethanol to obtain an acylation reagent solution;
[0051] Under ice bath conditions (0-5℃), the acylation reagent solution was slowly added dropwise to the aqueous solution of γ-polyglutamic acid at a rate of 1 mL / min, while stirring continuously. After the addition was completed, the reaction was continued for 2 hours.
[0052] After the reaction was completed, the reaction solution was dialyzed (the molecular weight cutoff of the dialysis bag was 8 kDa) for 72 hours, with the deionized water being replaced every 12 hours. After the dialysis was completed, the solution was freeze-dried to obtain acylated modified γ-polyglutamic acid, and its degree of modification was tested to be 25%.
[0053] Step 2: Preparation of controlled-release microspheres using the emulsification-crosslinking method:
[0054] Take 2g of the acylated modified γ-polyglutamic acid prepared in step 1 and dissolve it in 40mL of deionized water. Stir to dissolve and obtain the core material solution (concentration 50mg / mL).
[0055] Dissolve 6g of chitosan (degree of deacetylation ≥90%) in 120mL of 1% acetic acid solution and stir until completely dissolved to obtain a wall material solution (concentration 50mg / mL).
[0056] Add 0.6g of Tween-80 (emulsifier) to the wall material solution and stir until homogeneous;
[0057] The core material solution is slowly added to the wall material solution, and a high-speed disperser is turned on to emulsify at a speed of 12000 r / min for 20 min to form a stable O / W type emulsion.
[0058] Add 0.3g glutaraldehyde (crosslinking agent, 5% of the wall material mass) to the emulsion, heat to 35±2℃, and stir continuously at 500r / min for 3±0.5h to allow the wall material to crosslink and cure, with a crosslinking degree ≥85% (determined by gel permeation chromatography).
[0059] After the reaction was completed, the precipitate was collected by centrifugation (8000 r / min, 15 min), washed three times with deionized water and anhydrous ethanol, and then freeze-dried to obtain controlled-release microspheres.
[0060] Tests showed that the controlled-release microspheres had a particle size of 280 nm and a mass ratio of active core material to wall material of 1:3.
[0061] Step 3: Preparation of matrix material:
[0062] Take 8g of sodium hyaluronate (medical grade, molecular weight 800kDa) and add it to 100mL of deionized water. Heat the solution to 60℃ and stir for 30min until completely dissolved to obtain a gel matrix solution.
[0063] Add 5g of glycerin (moisturizing ingredient) and 1g of dipotassium glycyrrhizate (anti-inflammatory and soothing ingredient) to the gel matrix solution, and continue stirring at 50°C for 20 minutes until all ingredients are completely dissolved. Cool to room temperature to obtain the matrix material.
[0064] The mass fraction of sodium hyaluronate in the matrix material is 7.4%, glycerol is 4.6%, and dipotassium glycyrrhizate is 0.9%.
[0065] Step 4: Prepare the finished repair dressing:
[0066] Take 3g of the controlled-release microspheres prepared in step 2 and add them to the matrix material prepared in step 3. Disperse them by ultrasonication (power 200W, time 10min) until the controlled-release microspheres are uniformly dispersed.
[0067] The uniformly dispersed mixture was placed in a vacuum drying oven and degassed for 20 minutes under a pressure of -0.08 MPa to remove air bubbles.
[0068] The degassed mixture is filled into a medical-grade tubing and sterilized using a moist heat sterilization method (121℃, 0.1MPa, 20min) according to the characteristics of the gel formulation. After sterilization, the sterility of the product meets the requirements of GB15979-2002 "Hygienic Standard for Disposable Sanitary Products", thus obtaining the finished gel-type repair dressing.
[0069] Example 2: Graft-modified γ-polyglutamic acid + PLGA wall material controlled-release microsphere film dressing
[0070] Step 1: Preparation of grafted modified γ-polyglutamic acid (active core material):
[0071] Dissolve 8g of γ-polyglutamic acid (molecular weight 80kDa) in 150mL of deionized water, add 0.4g of ammonium persulfate (initiator), stir to dissolve, and then heat to 60℃;
[0072] Dissolve 6g of polyethylene glycol monomethyl ether methacrylate (grafted monomer, molecular weight 2kDa) in 30mL of deionized water, and slowly add it dropwise to the above solution. After the addition is complete, keep the temperature warm for 3h.
[0073] After the reaction was completed, the mixture was dialyzed (with a molecular weight cutoff of 10 kDa in the dialysis bag) for 48 hours and then freeze-dried to obtain grafted modified γ-polyglutamic acid, which was tested to have a modification degree of 32%.
[0074] Step 2: Preparation of controlled-release microspheres by solvent evaporation method:
[0075] Take 1g of the grafted modified γ-polyglutamic acid prepared in step 1 and dissolve it in 20mL of deionized water to obtain the core material solution;
[0076] Take 8g of polylactic acid-glycolic acid copolymer (PLGA, with a lactic acid to glycolic acid molar ratio of 5:5 and a molecular weight of 50kDa) and dissolve it in 40mL of dichloromethane to obtain a wall material solution;
[0077] The core material solution was added to the wall material solution and stirred at 8000 r / min for 10 min to form the primary emulsion.
[0078] Add the colostrum to 200 mL of deionized water containing 1 g of polyvinyl alcohol (emulsifier), and emulsify at a high speed of 15000 r / min for 30 min to form a secondary emulsion;
[0079] Place the double emulsion in a 30°C constant temperature water bath and stir for 6 hours to allow the dichloromethane to completely evaporate.
[0080] Centrifugation (10,000 r / min, 20 min) was performed to collect the precipitate, which was then washed four times with deionized water and freeze-dried to obtain controlled-release microspheres.
[0081] Tests showed that the controlled-release microspheres had a particle size of 150 nm and a mass ratio of active core material to wall material of 1:8.
[0082] Step 3: Preparation of matrix material:
[0083] Add 12g of sodium carboxymethyl cellulose (medical grade, degree of substitution 0.8) to 100mL of deionized water, heat to 70℃, and stir for 40min until completely dissolved;
[0084] Add 3g betaine (moisturizing ingredient) and 0.5g bisabolol (anti-inflammatory and soothing ingredient), continue stirring for 25 minutes until dissolved, cool to room temperature, and obtain the matrix material.
[0085] The mass fraction of sodium carboxymethyl cellulose in the matrix material is 10.5%, betaine is 2.6%, and bisabolol is 0.4%.
[0086] Step 4: Prepare the finished film dressing:
[0087] Take 2g of the controlled-release microspheres prepared in step 2 and add them to the matrix material in step 3. Disperse them uniformly by ultrasonication (300W power, 8min time).
[0088] The mixture was poured into a polytetrafluoroethylene mold and dried in a vacuum drying oven at 40°C for 12 hours to form a film with a thickness of 0.3 mm.
[0089] The film is cut to the preset size, sterilized with ethylene oxide (temperature 37℃, pressure 0.1MPa, time 6h), and packaged to obtain the finished film-form repair dressing.
[0090] Example 3: Controlled-release microsphere spray dressing made of hybrid wall material
[0091] Step 1: Preparation of acylated modified γ-polyglutamic acid (active core material):
[0092] Referring to step 1 of Example 1, the acylation reagent was replaced with acetic anhydride, the mass ratio of γ-polyglutamic acid to acetic anhydride was adjusted to 10:3, the reaction time was 1.5 h, and finally acylated modified γ-polyglutamic acid with a modification degree of 18% was obtained.
[0093] Step 2: Preparation of hybrid wall material controlled-release microspheres:
[0094] Take 3g of the acylated modified γ-polyglutamic acid prepared in step 1 and dissolve it in 60mL of deionized water to obtain the core material solution;
[0095] Take 6g of wall material mixture (sodium alginate and gelatin in a mass ratio of 1:1) and dissolve it in 150mL of deionized water. Heat the solution to 50℃ and stir to dissolve it, thus obtaining the wall material solution.
[0096] Add 0.5g Span-80 (emulsifier) to the wall material solution and stir until homogeneous;
[0097] The core material solution was added to the wall material solution and emulsified at 10,000 r / min for 25 min to form an emulsion.
[0098] Add 0.12g genipin (crosslinking agent, 2% of the wall material weight), and stir at 30℃ for 4 hours;
[0099] After centrifugation, washing, and drying, controlled-release microspheres were obtained. The particle size was measured to be 420 nm, and the mass ratio of active core material to wall material was 1:2.
[0100] Step 3: Preparation of matrix material:
[0101] Add 5g of medical grade polyacrylamide to 100mL of deionized water and stir at room temperature for 30min until dissolved;
[0102] Add 8g panthenol (moisturizing ingredient) and 3g ceramide (anti-inflammatory and soothing ingredient), and ultrasonically disperse (power 200W, time 5min) until completely dissolved to obtain the matrix material.
[0103] The mass fraction of polyacrylamide in the matrix material is 4.6%, panthenol is 7.4%, and ceramide is 2.8%.
[0104] Step 4: Prepare the finished spray dressing:
[0105] Take 4g of the controlled-release microspheres prepared in step 2 and add them to the matrix material in step 3. After ultrasonic dispersion, degas under vacuum for 30min.
[0106] The mixture is filled into medical-grade spray bottles and sterilized by irradiation (dose 25kGy) to obtain the finished spray-type repair dressing.
[0107] Performance test results:
[0108] The performance of the repair dressings prepared in Examples 1-3 above was tested. The test items and results are shown in the table below:
[0109] Test Project Example 1 (Gel) Example 2 (Film Formulation) Example 3 (Spray) Limited Scope Moisture content (%) 78 65 82 60-85 pH value 6.2 5.8 6.5 5.5-7.0 Tensile strength (MPa) 0.8 1.2 - (Liquid form) ≥0.5 Air permeability (g / (m²·24h)) 150 220 - (Liquid form) ≥100 24-hour cumulative release (%) 42 38 45 30-50 Cumulative release over 48 hours (%) 72 68 75 60-80 72-hour cumulative release (%) 93 91 95 ≥90
[0110] The test results above show that the repair dressings prepared in Examples 1-3 of this invention all meet the defined performance indicators. The release period of γ-polyglutamic acid is 72 hours, achieving a gradient release effect. Furthermore, a comparative experiment on wound repair after medical aesthetic procedures using the dressings of this invention (control group: gel dressing containing unmodified γ-polyglutamic acid) verifies that: the dressing group of this invention reduces the content of the inflammatory factor TNF-α by more than 40% (compared to a 15%-20% reduction in the control group), increases the epidermal cell proliferation rate by more than 35% (compared to a 10%-15% increase in the control group), increases the skin stratum corneum moisture content to more than 35% (compared to a 25%-30% increase in the control group), and reduces transepidermal water loss by more than 50% (compared to a 20%-25% reduction in the control group). This is significantly superior to existing products and is suitable for wound repair after medical aesthetic procedures and for sensitive skin barrier reconstruction.
[0111] The embodiments of the present invention are given for illustrative and descriptive purposes only, and are not intended to be exhaustive or to limit the invention to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described in order to better illustrate the principles and practical application of the invention, and to enable those skilled in the art to understand the invention and to design various embodiments with various modifications suitable for a particular purpose.
Claims
1. A medical-grade sensitive skin repair dressing with γ-polyglutamic acid controlled-release function, characterized in that: It includes controlled-release microspheres and a matrix material, wherein the controlled-release microspheres are uniformly dispersed in the matrix material; The controlled-release microspheres are composed of an active core material and a wall material. The active core material is modified γ-polyglutamic acid, which is obtained by acylation modification or graft modification, with a modification degree of 15%-40%. The wall material is selected from at least one of polylactic acid-glycolic acid copolymer, chitosan, sodium alginate, and gelatin. The mass ratio of the active core material to the wall material is 1:2-1:8, and the particle size of the controlled-release microspheres is 100-500 nm. The matrix material includes a medical-grade gel matrix, moisturizing ingredients, and anti-inflammatory and soothing ingredients. The medical-grade gel matrix accounts for 5%-15% of the matrix material by mass, the moisturizing ingredients account for 3%-8% by mass, and the anti-inflammatory and soothing ingredients account for 0.5%-3% by mass. The repair dressing achieves gradient release of γ-polyglutamic acid over 12-72 hours via controlled-release microspheres, with a cumulative release of 30%-50% over 24 hours, 60%-80% over 48 hours, and ≥95% over 72 hours.
2. The repair dressing according to claim 1, characterized in that, The modified γ-polyglutamic acid is a derivative obtained through acylation or grafting modification, with a modification degree of 15%-40%. The acylation reagent used in the acylation modification is a fatty acyl chloride or an acid anhydride, and the grafting monomer used in the grafting modification is acrylamide or polyethylene glycol monomethyl ether methacrylate.
3. The repair dressing according to claim 1, characterized in that, The wall material is selected from at least one of polylactic acid-glycolic acid copolymer, chitosan, sodium alginate, and gelatin; When the wall material is a polylactic acid-glycolic acid copolymer, the molar ratio of lactic acid to glycolic acid is 3:7-7:
3.
4. The repair dressing according to claim 1, characterized in that, The medical-grade gel matrix is selected from at least one of sodium hyaluronate, sodium carboxymethyl cellulose, and polyacrylamide.
5. The repair dressing according to claim 1, characterized in that, The controlled-release microspheres are prepared by an emulsification-crosslinking method or a solvent evaporation method, specifically including the following steps: The modified γ-polyglutamic acid was dissolved in an aqueous solvent to obtain a core material solution; The wall material is dissolved in an organic solvent to obtain a wall material solution; The core material solution is added to the wall material solution, and emulsified by high-speed stirring under the action of an emulsifier to form an emulsion; By adding a crosslinking agent or evaporating the solvent, controlled-release microspheres are obtained through curing. Wash and dry before use.
6. The repair dressing according to claim 6, characterized in that, The stirring speed during the emulsification process is 8000-15000 r / min, and the emulsification time is 10-30 min; The crosslinking agent is glutaraldehyde or genipin, and the amount added is 1%-5% of the wall material weight. The solvent has an evaporation temperature of 30-50℃ and an evaporation time of 2-6 hours.
7. The repair dressing according to claim 1, characterized in that, The method for preparing the repair dressing includes: The medical-grade gel matrix was added to deionized water, heated to dissolve, and stirred until homogeneous to obtain a matrix solution. Add moisturizing and anti-inflammatory soothing ingredients to the base solution and continue stirring until completely dissolved; The controlled-release microspheres were added to the above solution, ultrasonically dispersed until uniform, degassed, filled, and sterilized to obtain the finished product.
8. The repair dressing according to claim 1, characterized in that, The moisture content of the repair dressing was 60%-85%, determined by the Karl Fischer method; the pH value was 5.5-7.0, determined by a pH meter at 25℃; the tensile strength was ≥0.5MPa, determined by a universal testing machine at a tensile rate of 50mm / min; and the air permeability was ≥100g / (m²・24h), determined by the permeation cup method at 37℃ and a relative humidity of 50%. In simulated skin conditions, the cumulative release of γ-polyglutamic acid was 30%-50% in 24 hours, 60%-80% in 48 hours, and ≥90% in 72 hours.
9. The repair dressing according to any one of claims 1-8, characterized in that, The repair dressing is a gel dressing, film dressing, or spray dressing, used for wound repair or sensitive skin barrier reconstruction after medical aesthetic procedures. It can reduce wound inflammation, promote epidermal cell proliferation, and increase the water content of the stratum corneum and the barrier function against transepidermal water loss.