Medical glucan skin repair dressing as well as preparation method and application thereof

Abstract

The invention discloses a medical glucan skin repair dressing, which comprises Ectoine, beta-glucan, sodium hyaluronate, trehalose, sodium carboxymethyl cellulose and the like, and is a sterile liquid dressing without glycerol and traditional chemical preservatives. The dressing has appropriate viscosity, excellent film-forming property and flexibility, can quickly form a transparent, breathable and flexible protective film after being applied to a wound surface, can be used for nursing skin barrier injury, low sensitization and healing promotion of superficial wound surfaces, energy equipment postoperative wound surfaces and the like, and is convenient to use.

Description

A medical dextran skin repair dressing, its preparation method and application Technical Field

[0001] Technical Field This invention belongs to the field of medical technology, specifically relating to a medical dextran skin repair liquid dressing with ectoine and β-glucan as core active ingredients, its preparation method and application. Background Technology

[0002] As the body's first line of defense, the skin's integrity is compromised after physical injury or minimally invasive cosmetic procedures, making it prone to problems such as redness, stinging, dryness, infection, and delayed healing. Ideal wound care products should mimic the barrier function of healthy skin, providing a moist healing environment, and possess anti-inflammatory and immunomodulatory bioactivities to accelerate repair.

[0003] Currently available liquid dressings or care solutions commonly add glycerin as a moisturizer and methylparaben, phenoxyethanol, etc., as preservatives to achieve moisturizing and antiseptic purposes. However, glycerin poses a risk of sensitization to some sensitive skin types; while chemical preservatives may potentially irritate damaged wounds and delay healing. Furthermore, most existing products have relatively limited functions, focusing on physical coverage or basic moisturizing, lacking the ability to regulate the inflammatory response during wound healing. Therefore, developing a skin-repairing dressing that avoids common irritants, possesses moisturizing, repairing, anti-inflammatory, immunomodulatory, and film-forming functions, and uses safer materials is of great significance for improving the quality of postoperative and wound care. Summary of the Invention

[0004] The present invention aims to overcome the problems of high sensitization, single function, and insufficient synergistic effect of active ingredients in existing liquid dressings, and to provide a safe and efficient skin repair dressing, its preparation method and application.

[0005] To achieve the above objectives, the present invention adopts the following technical solution:

[0006] In a first aspect, the present invention provides a medical dextran skin repair dressing, comprising, by weight percentage: 0.1%-2.5% ectoine, 0.1%-1.0% β-glucan, 0.1%-0.5% sodium hyaluronate, 0.5%-2.0% trehalose, 0.5%-2.0% sodium carboxymethyl cellulose, with the balance being pharmaceutical water; the pH value of the dressing is 5.5-8.0; wherein the β-glucan is β-1,3 / 1,6-glucan or β-1,3 / 1,4-glucan; the molecular weight range is 20-800 kDa; and the molecular weight of the sodium hyaluronate is greater than 1000 kDa.

[0007] Preferably, the medical dextran skin repair dressing comprises, by weight percentage: 1.0% ectoine, 0.5% β-glucan, 0.3% sodium hyaluronate, 1.0% trehalose, 1.0% sodium carboxymethyl cellulose, with the remainder being pharmaceutical water.

[0008] Preferably, the pH value of the dressing is 6.0-8.0.

[0009] Preferably, the molecular weight of the β-glucan is in the range of 100-400 kDa, more preferably 150-400 kDa; the source is selected from yeast or oat, more preferably yeast.

[0010] Preferably, the sodium hyaluronate has a molecular weight of 1400 kDa.

[0011] Preferably, the dressing has a viscosity of 100-1000 mPa·s at 25°C, and the elongation at break of the protective film formed after drying is ≥120%.

[0012] The pharmaceutical water described in this invention is water for injection.

[0013] Secondly, the present invention provides a method for preparing the medical dextran skin repair dressing as described above, comprising the following steps:

[0014] (1) Sodium carboxymethyl cellulose was dispersed in a portion of pharmaceutical water and swollen to obtain a gel solution A;

[0015] (2) Dissolve ectoine, trehalose and β-glucan in part of the pharmaceutical water to obtain solution B;

[0016] (3) Sodium hyaluronate was dispersed by high-speed shearing in a portion of pharmaceutical water to obtain dispersion C;

[0017] (4) Add solution B and dispersion C to the adhesive solution A in sequence, mix well to form a mixed solution;

[0018] (5) Adjust the pH of the mixture to 5.5-8.0, add pharmaceutical water to the full volume, fill and seal;

[0019] (6) Sterilize the sealed product with moist heat.

[0020] Preferably, the amount of water used in pharmaceutical manufacturing in step (1) accounts for 30%-40% of the total water volume, the amount of water used in pharmaceutical manufacturing in step (2) accounts for 20%-30% of the total water volume, and the amount of water used in pharmaceutical manufacturing in step (3) accounts for 20%-30% of the total water volume.

[0021] Preferably, the sterilization conditions in step (6) are maintained at 121°C for 15 minutes.

[0022] Thirdly, the present invention provides the use of the medical dextran skin repair dressing described above in the preparation of medical products for the care and / or repair of skin barrier damage.

[0023] Preferably, the skin barrier damage is a superficial wound.

[0024] Furthermore, the superficial wounds are selected from surgical incisions, wounds after energy device surgery, wounds after microneedling, and burns of superficial second degree or less.

[0025] Preferably, the medical product is used by topical application or wet compress.

[0026] Compared with the prior art, the skin repair dressing of the present invention has the following advantages:

[0027] The synergistic mechanism is clearly defined: the core active ingredients, ectoine and β-glucan, work synergistically through different pathways. Ectoine primarily exerts protective, anti-inflammatory, and stabilizing effects at the cellular level; while β-glucan of specific molecular weights (especially the β-1,3 / 1,6-structure) can act on skin immune cell-related receptors, regulating the wound immune microenvironment and promoting repair. The two complement each other, achieving a coordinated synergistic effect of cellular protection and immune microenvironment regulation, jointly alleviating postoperative redness, swelling, and burning reactions, resulting in a repair effect superior to that of a single ingredient.

[0028] Significantly improved safety: The formula eliminates chemical preservatives such as glycerin, methylparaben, and phenoxyethanol commonly found in traditional liquid dressings, and selects trehalose as the main moisturizing ingredient, reducing the potential irritation and sensitization risks of the product from the source.

[0029] Excellent film-forming properties: A stable three-dimensional network structure is constructed through supramolecular interactions between sodium carboxymethyl cellulose and other components. This system gives the dressing a suitable viscosity, making it easy to apply, and after moisture evaporation, it can form a transparent, breathable, flexible (elongation at break ≥120%) continuous protective film on the wound surface.

[0030] Good adaptability and stability: The pH range of the dressing (5.5-8.0) can adapt to different wound microenvironments, while also helping to maintain the stability and bioactivity of each active ingredient.

[0031] The production process is simple and stable: the entire preparation process can be completed at room temperature without the need for complex temperature control, and the sterility of the product is ensured by the moist heat sterilization process after filling, which simplifies the production steps and is more conducive to large-scale preparation.

[0032] In summary, the skin repair dressing of the present invention eliminates common irritants, achieves the synergistic effect of ectoine and β-glucan through scientific synergy, and realizes the integrated functions of "moisturizing-repairing-anti-inflammatory-immunomodulation-film formation" through compounding with other components. It is safer to use, has a wider range of applications, a simpler production process, and is more suitable for industrial application. Attached Figure Description

[0033] Figure 1 shows the skin examination results of the skin repair experiment in Example 5, where Figure A shows the skin examination results of the brown area after treatment; Figure B shows the skin examination results of the red area after treatment; Figure C shows the skin examination results of the brown area before treatment; and Figure D shows the skin examination results of the red area after treatment. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described below with reference to specific embodiments and comparative examples. It should be understood that the embodiments described herein are for illustrative purposes only and do not constitute a limitation on the scope of protection of this invention. Unless otherwise specified, the raw materials used in the following embodiments are all raw materials that meet pharmaceutical or cosmetic specifications.

[0035] Example 1: Preparation of Medical Dextran Skin Repair Dressing (Sample 1)

[0036] Formula composition (by weight percentage):

[0037] Ectocin: 0.8%

[0038] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0039] Trehalose: 0.8%

[0040] Yeast β-glucan (β-1,3 / 1,6-glucan) (molecular weight approximately 180 kDa): 0.4%

[0041] Sodium carboxymethyl cellulose: 0.8%

[0042] Water for Injection: Balance

[0043] The target pH value of the system is 6.8.

[0044] Preparation method:

[0045] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0046] Dissolving the active ingredient: Add ectoine, trehalose and yeast β-glucan to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain a clear active ingredient solution B.

[0047] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0048] Mixing: At room temperature, slowly add solution B and dispersion C to the adhesive solution A in sequence, and stir at a moderate speed until the system is homogeneous.

[0049] Post-treatment: Adjust the pH of the mixture to 6.8 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add water for injection to the full volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0050] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain medical dextran skin repair dressing sample 1.

[0051] Example 2: Preparation of Medical Dextran Skin Repair Dressing (Sample 2)

[0052] Formula composition (by weight percentage):

[0053] Ectocin: 1.2%

[0054] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0055] Trehalose: 1.2%

[0056] Oat-derived β-glucan (β-1,3 / 1,4-glucan) (molecular weight approximately 150 kDa): 0.6%

[0057] Sodium carboxymethyl cellulose: 1.2%

[0058] Water for Injection: Balance

[0059] The target pH value of the system is 7.2.

[0060] Preparation method:

[0061] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0062] Dissolving the active ingredient: Add ectoine, trehalose, and oat-derived β-glucan to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain a clear active ingredient solution B.

[0063] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0064] Mixing: At room temperature, slowly add solution B and dispersion C to the adhesive solution A in sequence, and stir at a moderate speed until the system is homogeneous.

[0065] Post-treatment: Adjust the pH of the mixture to 7.2 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add water for injection to the full volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0066] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain medical dextran skin repair dressing sample 2.

[0067] Example 3: Preparation of Medical Dextran Skin Repair Dressing (Sample 3)

[0068] Formula composition (by weight percentage):

[0069] Ectocin: 1.0%

[0070] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0071] Trehalose: 1.0%

[0072] Yeast β-glucan (β-1,3 / 1,6-glucan) (molecular weight approximately 300 kDa): 0.5%

[0073] Sodium carboxymethyl cellulose: 1.0%

[0074] Water for Injection: Balance

[0075] The target pH value of the system is 7.0.

[0076] Preparation method:

[0077] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0078] Dissolving the active ingredient: Add ectoine, trehalose and yeast β-glucan to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain a clear active ingredient solution B.

[0079] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0080] Mixing: At room temperature, slowly add solution B and dispersion C to the adhesive solution A in sequence, and stir at a moderate speed until the system is homogeneous.

[0081] Post-treatment: Adjust the pH of the mixture to 7.0 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add water for injection to the full volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0082] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain medical dextran skin repair dressing sample 3.

[0083] Example 4: Preparation of Medical Dextran Skin Repair Dressing (Sample 4)

[0084] Formula composition (by weight percentage):

[0085] Ectocin: 1.0%

[0086] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0087] Trehalose: 1.0%

[0088] Yeast β-glucan (β-1,3 / 1,6-glucan) (molecular weight approximately 400 kDa): 0.5%

[0089] Sodium carboxymethyl cellulose: 1.0%

[0090] Water for Injection: Balance

[0091] The target pH value of the system is 7.0.

[0092] Preparation method:

[0093] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0094] Dissolving the active ingredient: Add ectoine, trehalose and yeast β-glucan to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain a clear active ingredient solution B.

[0095] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0096] Mixing: At room temperature, slowly add solution B and dispersion C to the adhesive solution A in sequence, and stir at a moderate speed until the system is homogeneous.

[0097] Post-treatment: Adjust the pH of the mixture to 7.0 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add water for injection to the full volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0098] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain medical dextran skin repair dressing sample 4.

[0099] Example 5: Screening of different film-forming matrices

[0100] Formula composition (by weight percentage):

[0101] Ectocin: 1.0%

[0102] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0103] Trehalose: 1.0%

[0104] Yeast β-glucan (β-1,3 / 1,6-glucan) (molecular weight approximately 400 kDa): 0.5%

[0105] Film-forming matrix

[0106] Water for Injection: Balance

[0107] The target pH value of the system is 7.0.

[0108] Dressing samples were prepared using the following three film-forming matrices:

[0109] Sample E5-1: CMCNa (1.0%)

[0110] Sample E5-2: Carbomer 940 (1.0%)

[0111] Sample E5-3: CMCNa (1.0%) + Carbomer 940 (0.2%) composite system

[0112] All samples were prepared using the same process as in Example 1, with pH adjusted to 7.0 and sterilization conditions of 121°C for 15 minutes.

[0113] Test method:

[0114] Viscosity measurement: Measured using a rotational viscometer at 25℃.

[0115] Film-forming properties: Take 2 mL of sample and coat it evenly on the surface of detached pigskin. After drying at room temperature, measure the elongation at break and uniformity of the protective film (visual and microscopic observation).

[0116] Rheological properties: Its shear thinning behavior and recovery properties were measured using a rheometer.

[0117]

[0118] The results showed that although the carbomer system (sample E5-2) had a higher viscosity, its film flexibility after formation was significantly lower than that of the CMCNa system, and the film was prone to microcracks, affecting the continuity of protection. While the composite system (sample E5-3) showed slightly improved flexibility and film uniformity, it still did not match the overall performance of the single CMCNa system. Compared to both the carbomer and composite systems, CMCNa exhibited significantly improved swelling properties, film continuity, and flexibility, making it more suitable as the film-forming matrix for this dressing.

[0119] Example 6: Study on the stability of β-glucan in different component systems

[0120] Prepare four systems containing the same concentration of β-glucan (0.5%), and observe the color differences immediately after sterilization:

[0121] Sample E6-1 (complete system of this invention): Ectoin 1.0%, β-glucan (yeast, 300 kDa) 0.5%, sodium hyaluronate 0.3%, trehalose 1.0%, sodium carboxymethyl cellulose 1.0%, water for injection balance, pH 7.0.

[0122] Sample E6-2 (without sodium hyaluronate and trehalose): Ectoin 1.0%, β-glucan 0.5%, sodium carboxymethyl cellulose 1.0%, water for injection balance, pH 7.0.

[0123] Sample E6-3 (without ectoine): β-glucan 0.5%, sodium hyaluronate 0.3%, trehalose 1.0%, sodium carboxymethyl cellulose 1.0%, water for injection balance, pH 7.0.

[0124] Sample E6-4 (β-glucan simple aqueous solution): 0.5% β-glucan dissolved in water for injection, pH 7.0.

[0125] After all samples were filled, they were immediately subjected to moist heat sterilization at 121°C for 15 minutes. After sterilization, they were cooled to room temperature and observed for color under the same light conditions.

[0126] Evaluation method:

[0127] Visual colorimetric method: Place the sterilized sample against a white background and compare it with standard colorless pure water. Observe and record the color directly.

[0128]

[0129] The results showed that after undergoing the same terminal moist heat sterilization treatment, β-glucan exhibited significant differences in immediate color stability under different formulation environments. The simple aqueous solution of β-glucan (sample E6-4) showed a noticeable yellowing change immediately after sterilization. Some formulation systems of this invention (samples E6-2 and E6-3) also showed varying degrees of yellowing after sterilization. In contrast, the complete formulation system of this invention (sample E6-1) maintained the color stability of β-glucan to the greatest extent, with the solution color after sterilization being similar to that of pure water. This directly proves that the composite system provided by this invention, consisting of ectoin, sodium hyaluronate, trehalose, and sodium carboxymethyl cellulose, can effectively provide immediate protection for β-glucan in the crucial sterilization process, significantly inhibiting early degradation or color changes that may be caused by heat effects, thereby ensuring the initial appearance quality and component stability of the product.

[0130] Comparative Example 1: Conventional dressings containing glycerin and chemical preservatives

[0131] Formula composition (by weight percentage):

[0132] Ectocin: 0.8%

[0133] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0134] Glycerin: 5.0%

[0135] Sodium carboxymethyl cellulose: 0.8%

[0136] Methylparaben: 0.1%

[0137] Water for Injection: Balance

[0138] Adjust the pH value to 6.8.

[0139] Preparation method:

[0140] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0141] Dissolving the active ingredient: Add ectoine to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain solution B.

[0142] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0143] Mixing: At room temperature, slowly add solution B, dispersion C and glycerol to gel A in sequence, and stir at a moderate speed until the system is homogeneous.

[0144] Post-treatment: Adjust the pH of the mixture to 6.8 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add methylparaben and stir to dissolve. Add water for injection to the total volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0145] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain the product of Comparative Example 1.

[0146] Comparative Example 2: Dressings using dextran with a molecular weight of 10 kDa

[0147] Formula composition (by weight percentage):

[0148] Ectocin: 0.8%

[0149] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0150] Trehalose: 0.8%

[0151] Yeast β-glucan fragment (β-1,3 / 1,6-glucan) (molecular weight approximately 10 kDa): 0.4%

[0152] Sodium carboxymethyl cellulose (low viscosity): 0.8%

[0153] Water for Injection: Balance

[0154] The target pH value of the system is 6.8.

[0155] Preparation method:

[0156] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0157] Dissolving the active ingredient: Add ectoine, trehalose and yeast β-glucan fragments to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain a clear active ingredient solution B.

[0158] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0159] Mixing: At room temperature, slowly add solution B and dispersion C to the adhesive solution A in sequence, and stir at a moderate speed until the system is homogeneous.

[0160] Post-treatment: Adjust the pH of the mixture to 6.8 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add water for injection to the full volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0161] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain the product of Comparative Example 2.

[0162] Comparative Example 3: Dressings lacking β-glucan

[0163] Formula composition (by weight percentage):

[0164] Ectocin: 0.8%

[0165] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0166] Trehalose: 0.8%

[0167] Sodium carboxymethyl cellulose: 0.8%

[0168] Water for Injection: Balance

[0169] Adjust the pH value to 6.8.

[0170] Preparation method:

[0171] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0172] Dissolving active ingredients: Add ectoine and trehalose to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain solution B.

[0173] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0174] Mixing: At room temperature, slowly add solution B and dispersion C to the adhesive solution A in sequence, and stir at a moderate speed until the system is homogeneous.

[0175] Post-treatment: Adjust the pH of the mixture to 6.8 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add water for injection to the full volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0176] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain the product of Comparative Example 3.

[0177] Comparative Example 4: Dressings using phenoxyethanol as a preservative

[0178] Formula composition (by weight percentage):

[0179] Ectocin: 0.8%

[0180] Sodium hyaluronate (molecular weight 1400 kDa): 0.3%

[0181] Glycerin: 5.0%

[0182] Sodium carboxymethyl cellulose: 0.8%

[0183] Phenoxyethanol: 0.5%

[0184] Water for Injection: Balance

[0185] Adjust the pH value to 6.8.

[0186] Preparation method:

[0187] Preparation of the adhesive solution: While stirring, slowly add sodium carboxymethyl cellulose (CMC) to 40% of the total water volume of water for injection, and continue stirring for about 60 minutes until it is completely swollen and dispersed to obtain a uniform and transparent adhesive solution A.

[0188] Dissolving the active ingredient: Add ectoine to another portion (30% of the total water volume) of water for injection and stir until completely dissolved to obtain solution B.

[0189] Sodium hyaluronate dispersion: Sodium hyaluronate was slowly added to the remaining portion (30% of the total water volume) of water for injection under high-speed shear (8000 rpm) and dispersed evenly to obtain dispersion C.

[0190] Mixing: At room temperature, slowly add solution B, dispersion C and glycerol to gel A in sequence, and stir at a moderate speed until the system is homogeneous.

[0191] Post-treatment: Adjust the pH of the mixture to 6.8 ± 0.2 with dilute lactic acid solution or dilute sodium hydroxide solution. Add phenoxyethanol and stir to dissolve. Add water for injection to the total volume of the formulation, and briefly remove air bubbles introduced during stirring using a vacuum degassing device.

[0192] Filling and sterilization: After filling and sealing, the above mixture is sterilized by moist heat at 121°C for 15 minutes to obtain the product of Comparative Example 4.

[0193] Example 1: Product physicochemical and film-forming property testing

[0194] The basic physicochemical properties and film-forming properties of the medical dextran skin repair dressing samples 1-4 obtained in Examples 1-4 and the products of Comparative Examples 1-4 were tested.

[0195] (1) Physicochemical properties: Samples 1-4 were all clear and transparent liquids, with no visible foreign matter. Their viscosity (25℃) and pH value are shown in the table below:

[0196]

[0197] (2) Film-forming properties: Take 2 mL of each sample and coat it evenly on the surface of the isolated pig skin. After drying naturally at room temperature, measure the elongation at break of the protective film.

[0198]

[0199] The results show that all the medical dextran skin repair dressing samples of the present invention can form a flexible protective film, among which sample 4 obtained in Example 4 has the most outstanding performance.

[0200] The results show that all the medical dextran skin repair dressing samples of the present invention can form a flexible protective film, among which the performance of sample 4 in Example 4 is the most outstanding.

[0201] Example 2: Evaluation of in vitro biological activity

[0202] (1) Cell repair activity (scratch assay): The human immortalized keratinocyte (HaCaT) model was used to evaluate the promoting effect of the sample on cell migration. After 24 hours of culture, the percentage of cell migration and healing area was calculated.

[0203]

[0204] Data shows that samples 1-4 of the medical dextran skin repair dressing of the present invention can significantly promote cell migration (p < 0.01 vs. blank control), which is significantly better than each pair of ratios, among which sample 4 obtained in Example 4 has the best effect.

[0205] (2) Immunomodulatory activity: In a lipopolysaccharide (LPS)-stimulated macrophage model, the inhibition rate of the sample on the release of the key pro-inflammatory factor TNF-α was detected.

[0206]

[0207] The results show that the β-glucan with a molecular weight range of 20-800 kDa selected in this invention has better immunomodulatory function, and increasing the molecular weight within this range can further enhance this activity.

[0208] Example 3: Evaluation of moisturizing performance and safety

[0209] (1) Moisturizing performance: The moisture content of the sample was measured after 6 hours in a constant temperature and humidity chamber (25℃, 30% RH).

[0210]

[0211] The moisturizing and long-lasting properties of the medical dextran skin repair dressing samples 1 and 4 of this invention are significantly better than those of the traditional formula containing glycerin (Comparative Example 1).

[0212] (2) Preliminary safety (human patch test): Closed patch test was conducted on 30 healthy volunteers.

[0213]

[0214] The experimental results demonstrate that the medical dextran skin repair dressing system of this invention, which is free of glycerin and chemical preservatives, has significantly higher safety.

[0215] Example 4: Stability Test

[0216] The medical dextran skin repair dressing (sample 1) prepared in Example 1 was placed under accelerated stability test conditions (40℃ ± 2℃, 75% ± 5% RH) for 6 months, and key indicators were sampled and tested periodically.

[0217] The results are as follows:

[0218] Appearance: Always remains clear and transparent, with no visible foreign matter or sediment.

[0219] pH value: stable between 6.75 and 6.90.

[0220] Viscosity (25℃): fluctuates in the range of 115-125 mPa·s, with a change rate of less than 10% compared to the initial value (120 mPa·s).

[0221] Key ingredient content: Ectoin retention rate is greater than 98.5%.

[0222] Aseptic assurance: The aseptic test results are satisfactory.

[0223] The above results show that the key quality properties of the product of the present invention remain stable under accelerated conditions and exhibit good long-term storage stability.

[0224] The above embodiments demonstrate that the medical dextran skin repair dressing of the present invention can be prepared under conventional processes. The comprehensive results demonstrate that the dressing of the present invention possesses suitable physicochemical properties, can form a flexible protective film, and exhibits significant properties in promoting cell repair, regulating immune responses, and providing long-lasting moisturizing, while also demonstrating high safety. Accelerated stability testing results show that the product exhibits good long-term stability.

[0225] Through systematic comparison with comparative examples, it was further verified that: (1) eliminating glycerol and chemical preservatives can significantly improve safety; (2) selecting β-glucan with a molecular weight range of 20-800 kDa is crucial for achieving excellent immunomodulatory and repair effects; and (3) β-glucan and ectoine synergistically constitute the core active matrix. Therefore, the technical solution of the present invention has significant progress compared with the prior art.

[0226] Example 5: Human Skin Repair Trial

[0227] Experimental procedure: Skin analyzer: Youyan 3D

[0228] Testing process:

[0229] 1. Before treatment, cleanse your face and remove makeup, then place your face into the imaging area of ​​the detector;

[0230] 2. Take photos from the front, 45° left and right, and 90° left and right angles respectively;

[0231] 3. Take post-operative photos 8 days after skin treatment, including photos from the front, 45° left and right, and 90° left and right angles.

[0232] 4. Shooting modes include: Natural Light, Cross Polarization, Parallel Polarization, Ultraviolet Light, Red Area, Brown Area, Ultraviolet Spot, Comprehensive Heat Mapping, Red Area Heat Mapping, Red Blood Vessels, Cool Light Mapping, and Enhanced Comprehensive Area Mapping.

[0233] Experimental results: After one week of using the dressing prepared in Example 4, the skin showed significant improvement in all multidimensional measurements (see attached diagram in the instruction manual):

[0234] Improved skin tone evenness: Grayscale images show a more even and radiant skin tone;

[0235] Reduced pigmentation and age spots: Ultraviolet spots are significantly lighter in images with ultraviolet light and brown areas;

[0236] Redness and inflammation relief: Thermal images of the red areas show significant shrinkage of the facial redness area;

[0237] Improved skin texture: Skin texture is smoother in both cross-polarized and parallel-polarized images.

[0238] The results show that the excipients prepared by this invention have comprehensive and efficient repair properties in terms of brightening and uniformity, lightening spots and redness, and soothing and stabilizing.

Claims

1. A medical dextran skin repair dressing, characterized in that, The dressing comprises, by weight percentage: 0.1%-2.5% ectoine, 0.1%-1.0% β-glucan, 0.1%-0.5% sodium hyaluronate, 0.5%-2.0% trehalose, and 0.5%-2.0% sodium carboxymethyl cellulose, with the balance being pharmaceutical water. The pH of the dressing is 5.5-8.

0. The β-glucan is β-1,3 / 1,6-glucan or β-1,3 / 1,4-glucan with a molecular weight range of 20-800 kDa. It is derived from yeast or oats. The sodium hyaluronate has a molecular weight greater than 1000 kDa.

2. The dressing as described in claim 1, characterized in that, By weight percentage, it includes: 1.0% ectoine, 0.5% β-glucan, 0.3% sodium hyaluronate, 1.0% trehalose, 1.0% sodium carboxymethyl cellulose, and the balance is pharmaceutical water.

3. The dressing as described in claim 1, characterized in that, The dressing has a pH value of 6.0-8.

0.

4. The dressing as described in claim 1, characterized in that, The β-glucan has a molecular weight range of 100-400 kDa and is derived from yeast.

5. The dressing as claimed in claim 1, characterized in that, The molecular weight of the sodium hyaluronate is 1400 kDa.

6. The dressing as claimed in claim 1, characterized in that, The dressing has a viscosity of 100-1000 mPa·s at 25°C, and the elongation at break of the protective film formed after drying is ≥120%.

7. A method for preparing a medical dextran skin repair dressing as described in any one of claims 1-6, characterized in that, Includes the following steps: (1) Disperse sodium carboxymethyl cellulose in pharmaceutical water, stir and swell to obtain solution A; (2) Dissolve ectoine, trehalose and β-glucan in pharmaceutical water to obtain solution B; (3) Disperse sodium hyaluronate in pharmaceutical water under high-speed shear to obtain dispersion C; (4) Add solution B and dispersion C to solution A in sequence, mix evenly to form a mixture; (5) Adjust the pH of the mixture to 5.5-8.0, add pharmaceutical water to the full volume, fill and seal; (6) Sterilize the sealed product with moist heat.

8. The method as described in claim 7, characterized in that, In step (1), the amount of water used for pharmaceutical manufacturing accounts for 30%-40% of the total water volume; in step (2), the amount of water used for pharmaceutical manufacturing accounts for 20%-30% of the total water volume; and in step (3), the amount of water used for pharmaceutical manufacturing accounts for 20%-30% of the total water volume.

9. The use of the medical dextran skin repair dressing according to any one of claims 1-6 in the preparation of medical products for the care and / or repair of skin barrier damage.

10. The application as described in claim 9, characterized in that, The skin barrier damage is a superficial wound.

11. The application as described in claim 10, characterized in that, The superficial wounds are selected from surgical incisions, wounds after energy device surgery, wounds after microneedling, and burns of less than degree II.

12. The application as described in any one of claims 9-11, characterized in that, The medical product is used by external application or wet compress.

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