Skin non-chronic wound repair dressing

Abstract

The invention relates to the field of hyaluronic acid products, and particularly discloses a skin non-chronic wound repair dressing, sodium hyaluronates with two molecular weights are selected and matched to obtain composite sodium hyaluronate, and the sodium hyaluronate with the large molecular weight forms a protective layer on a skin wound to provide a relatively closed environment for the skin wound, so that the skin non-chronic wound repair dressing has a good application prospect. The risk that the wound surface is infected by external microorganisms is blocked, sodium hyaluronate with medium molecular weight is dissociated on the surface of the protective layer, a wet environment is provided for the skin wound surface by absorbing moisture of the environment and the skin, the skin cell activity is improved, and the wound surface skin repairing and healing speed is increased.

Description

Technical Field

[0001] The invention relates to the product field of hyaluronic acid, and in particular to a skin non-chronic wound repair dressing. Background Art

[0002] In daily life, people are always facing the risk of skin wounds such as cuts, burns, stab wounds, facial laser, photorejuvenation, acid peel, micro plastic surgery, etc. Due to the small wound size and fast-paced life, these wounds are often not taken seriously and cannot be effectively treated. Under normal circumstances, the human skin will slowly repair and heal. During the entire repair process, these wounds will bring many inconveniences to people, and may even worsen the wounds and cause complications such as fever and inflammation due to wound infection, leading to a reduced quality of life, disrupting the rhythm of life, and affecting work mood.

[0003] Existing wound dressings are often inconvenient to use and may need to be cleaned and replaced several times a day. In today's fast-paced life, people often forget to replace them, causing the wound dressings to fail to play their due role and increasing the risk of wound infection.

[0004] Because the capillaries in the wound skin cannot effectively obtain sufficient nutrients through the capillaries, the skin barrier is damaged, causing the activity of the skin cells in the wound to be far below the normal range and the skin to be abnormally sensitive. The pH value, osmotic pressure and other microenvironments of the wound skin will also fluctuate greatly. The microbial flora of the wound skin is unbalanced, beneficial microbial flora is often inhibited, and harmful microbial flora is able to multiply rapidly. The emergence of these problems hinders the effective recovery of skin wounds.

[0005] Therefore, a wash-free wound dressing that can effectively maintain the microenvironment of the wound skin such as moisture, pH and osmotic pressure for a long time, reduce the sensitivity of the wound skin cells, maintain the balance of the microbial flora of the wound skin, and provide the wound skin with the necessary nutrients can effectively improve people's quality of life and ensure that it will not disrupt the fast pace of life. Summary of the invention

[0006] In order to address the deficiencies of the prior art, the present invention proposes a skin non-chronic wound repair dressing, which can effectively maintain the microenvironment of the wound skin such as moisture, pH and osmotic pressure for a long time, reduce the sensitivity of wound skin cells, maintain the balance of microbial flora on the wound skin, and provide the wound skin with necessary nutrients.

[0007] The skin non-chronic wound repair dressing provided by the present invention comprises the following components by weight:

[0008] Compound sodium hyaluronate 0.1-3.0%,

[0009] Skin adhesive 0.5-5.0%,

[0010] Bacteria regulator 0.1-2.0%,

[0011] Microenvironment regulator 0.1-3.0%,

[0012] Osmotic pressure regulator 0.5-9.0%,

[0013] The balance is water.

[0014] Furthermore, the composite sodium hyaluronate is prepared by mixing sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and sodium hyaluronate with a molecular weight of 800,000-1.5 million Da in a ratio of 1-5:1-2;

[0015] Furthermore, the ratio of the sodium hyaluronate with a molecular weight of 1.8-3.5 million Da to the sodium hyaluronate with a molecular weight of 800,000-1.5 million Da is in the range of 2-3:1-2; the more preferred ratio is 1.5:1.

[0016] Furthermore, the composite sodium hyaluronate preparation process is: after physically mixing sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and sodium hyaluronate with a molecular weight of 800,000-1.5 million Da in proportion, stirring and dissolving them in the formula water at room temperature to obtain a uniform gel with a certain fluidity, the mass fraction of which is preferably 0.5-1.5%.

[0017] Furthermore, the skin adhesive is one or a combination of any proportion of dextran, amino acid, collagen, polypeptide, sodium pyrrolidonecarboxylate, preferably 1.0-1.5%.

[0018] Furthermore, the flora regulator is one or more combinations of any proportions of sodium chloride, phosphates (disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate), EDTA and its salts (ethylenediaminetetraacetic acid, sodium ethylenediaminetetraacetate, disodium ethylenediaminetetraacetate, trisodium ethylenediaminetetraacetate, tetrasodium ethylenediaminetetraacetate, disodium calcium ethylenediaminetetraacetate), and dipotassium glycyrrhizinate, preferably 0.5-0.90%.

[0019] Furthermore, the microenvironment regulator is one or a combination of any proportion of ectoine, dipotassium glycyrrhizinate, licorice extract, dextran, sodium chloride, phosphate (disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate), citric acid, sodium citrate, tartaric acid, sodium tartrate, lactic acid, sodium lactate, sodium carbonate, and sodium bicarbonate, preferably 0.5-2.0%.

[0020] Furthermore, the osmotic pressure regulator is a combination of one or more of potassium chloride, mannitol, glucose, glycerol, propylene glycol, butylene glycol, composite sodium hyaluronate, skin adhesive, flora regulator, and microenvironment regulator in any proportion, preferably 1.0-6.5%.

[0021] The preparation method of the above-mentioned skin non-chronic wound repair dressing comprises the steps of:

[0022] 1) dissolving composite sodium hyaluronate;

[0023] 2) Add skin adhesive, flora regulator, and microenvironment regulator and dissolve completely;

[0024] 3) adding an osmotic pressure regulator to step 2) and stirring to dissolve;

[0025] 4) Add the remaining amount of water and stir under vacuum until completely dissolved;

[0026] Furthermore, the composite sodium hyaluronate adopts 40-60% of the formula water.

[0027] Furthermore, the osmotic pressure regulator is stirred at a low speed of 40-50 rpm for 20-40 minutes.

[0028] Furthermore, the vacuum stirring conditions are: 0.05-0.06Mpa pressure maintenance and 40-50rpm low speed stirring.

[0029] A skin non-chronic wound repair dressing, which is used for the care of superficial wounds, small wounds, abrasions, first-degree or shallow second-degree burn wounds, facial laser, photorejuvenation, fruit acid peeling, non-chronic wounds after micro-plastic surgery and surrounding skin.

[0030] Skin adhesive is used to increase the adhesion between the dressing and the wound skin and increase the residence time of the dressing on the wound skin.

[0031] Through the use of flora regulators and microenvironment regulators, the flora of the wound skin and a stable healing environment can be maintained for a long time, avoiding unnecessary infection risks caused by frequent cleaning.

[0032] A stable healing environment includes but is not limited to pH, osmotic pressure, and microbial flora.

[0033] The wound healing agent is used to speed up the healing of skin wounds.

[0034] Furthermore, the pH is preferably 6.8-7.6, more preferably 7.0-7.4.

[0035] Furthermore, the osmotic pressure is preferably 270 mOsmol / kg to 350 mOsmol / kg, more preferably 290 mOsmol / kg to 320 mOsmol / kg.

[0036] The preparation process of the invention is simple to operate and energy-saving and effective; there are few control parameters, and each operation step can be effectively controlled; the prepared product has stable performance.

[0037] Sodium hyaluronate, also known as sodium hyaluronate, is a linear glucuronic acid macromolecular polysaccharide composed of repeating units of D-glucuronic acid and N-acetyl-D-glucosamine. D-glucuronic acid and N-acetyl-D-glucosamine are linked by β-1,3 glycosidic bonds. Sodium hyaluronate is widely present in human joints, lenses, dermis and other tissues, and has extremely high safety. Sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and sodium hyaluronate with a molecular weight of 800,000-1.5 million Da are used with appropriate skin adhesives for non-chronic wound dressings. After application, a good breathable film with a tight texture that is tightly combined with the wound skin can be formed on the wound surface, which can reduce the number of replacements and eliminate the need for cleaning. It can effectively prevent wound infection for a long time and provide a stable environment for wound recovery.

[0038] The beneficial technical effects achieved by adopting the above technical solution are:

[0039] 1. The present invention selects two kinds of sodium hyaluronate with different molecular weights to obtain composite sodium hyaluronate. The high molecular weight sodium hyaluronate forms a protective layer on the skin wound surface, thereby providing a relatively closed environment for the skin wound surface and blocking the risk of external microorganisms infecting the wound surface. The medium molecular weight sodium hyaluronate is free on the surface of the protective layer, and absorbs moisture from the environment and the skin to provide a moist environment for the skin wound surface, thereby increasing the activity of skin cells and accelerating the speed of skin repair and healing on the wound surface. The medium molecular weight sodium hyaluronate adheres more closely to the skin surface of the wound surface, thereby ensuring that the dressing adheres more permanently to the skin surface.

[0040] 2. The present invention adds a skin adhesive to increase the adhesion of the film to the skin after the product is applied to the wound surface, so as to ensure that the formed film is more closely combined with the skin wound surface and adheres to the skin for a long time, thereby achieving more lasting protection and promoting the healing of the skin wound surface;

[0041] 3. The present invention prevents the excessive growth of harmful bacteria by adding flora regulators, ensures the balance of microbial flora on the wound skin, prevents excessive production of harmful bacteria, and reduces the risk of wound infection; by adding microenvironment regulators, the microenvironment of the wound skin is adjusted to a better condition for wound repair, promotes wound skin repair, reduces the discomfort caused by the wound, increases the healing speed of the skin wound, and shortens the healing cycle. DETAILED DESCRIPTION

[0042] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] The present invention adopts the following preparation process:

[0044] 1. Weigh composite sodium hyaluronate, add water to 40-60% of the formula, and stir at 80-120 rpm until completely dissolved and free of particles to obtain a pre-dissolved gel;

[0045] 2. Add 0.5-5.0% skin adhesive, 0.1-2.0% flora regulator, and 0.1-3.0% microenvironment regulator to step 1), stir at 40-80 rpm until completely dissolved, and measure pH;

[0046] 3. After the pH stabilizes, weigh 0.5-9.0% osmotic pressure regulator and stir at a low speed of 40-50 rpm for 20 minutes;

[0047] 4. Add the remaining water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved.

[0048] 5. When the prepared material is completely dissolved and the product is evenly dispersed without obvious bubbles, the preparation is completed and the product is filled into the container.

[0049] Embodiment 1:

[0050] Table 1 Example 1 Formula ratio

[0051]

[0052] Specific preparation process (in mass percentage w%):

[0053] 1) Disperse 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0054] 2) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, and 0.08% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0055] 3) After the pH stabilizes, add 0.35% sodium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0056] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0057] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0058] Embodiment 2:

[0059] The main difference between Example 2 and Example 1 is that the amount of composite sodium hyaluronate added is different. The amount of composite sodium hyaluronate added in Example 2 is 0.5% (0.30% for 1.8-3.5 million Da molecular weight sodium hyaluronate and 0.20% for 800,000-1.5 million Da molecular weight sodium hyaluronate).

[0060] Specific preparation process (in mass percentage w%):

[0061] 1) Disperse 0.5% composite sodium hyaluronate (0.30% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.20% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0062] 2) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, and 0.08% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0063] 3) After the pH stabilizes, add 0.35% sodium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0064] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0065] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0066] Embodiment 3:

[0067] The main difference between Example 3 and Example 2 is that the amount of composite sodium hyaluronate added is different. The amount of composite sodium hyaluronate added in Example 3 is 1.5% (0.90% of 1.8-3.5 million Da molecular weight sodium hyaluronate and 0.60% of 800,000-1.5 million Da molecular weight sodium hyaluronate).

[0068] Specific preparation process (in mass percentage w%):

[0069] 1) Disperse 1.5% composite sodium hyaluronate (0.90% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.60% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0070] 2) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, and 0.08% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0071] 3) After the pH stabilizes, add 0.35% sodium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0072] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0073] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0074] Embodiment 4:

[0075] The main difference between Example 4 and Example 1 is that the skin adhesive comprises dextran, amino acids, and collagen, and potassium chloride is added as an osmotic pressure regulator. For details, see the following formula ratio.

[0076] Table 2 Example 4 Formula Ratio

[0077]

[0078] Specific preparation process (in mass percentage w%):

[0079] 1) Disperse 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 800,000-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0080] 2) adding 0.15% dextran, 0.60% amino acid, 0.25% collagen, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, and 0.10% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0081] 3) After the pH stabilizes, add 0.18% sodium chloride and 0.61% potassium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0082] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0083] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0084] Embodiment 5:

[0085] The main difference between Example 5 and Example 4 is that the added amounts of skin adhesive amino acids and collagen and the added amount of osmotic pressure regulator potassium chloride are different. In Example 5, the added amount of skin adhesive amino acids is 0.95%, the added amount of collagen is 0.40%, and the added amount of potassium chloride is 0.50%.

[0086] Specific preparation process (in mass percentage w%):

[0087] 1) Disperse 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 800,000-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0088] 2) adding 0.15% dextran, 0.95% amino acid, 0.40% collagen, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, and 0.10% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0089] 3) After the pH stabilizes, add 0.18% sodium chloride and 0.50% potassium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0090] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0091] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0092] Embodiment 6:

[0093] The main difference between Example 6 and Example 1 is the different amount of flora regulator added, see the formula ratio below for details.

[0094] Table 3 Example 6 Formula Ratio

[0095]

[0096] Specific preparation process (in mass percentage w%):

[0097] 1) Disperse 0.80% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 800,000-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at a stirring speed of 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0098] 2) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.04% lactic acid, 0.15% sodium citrate, 0.40% ectoine, 0.57% licorice extract, and 0.10% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0099] 3) After the pH is stabilized, add 2.10% mannitol to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0100] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0101] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0102] Embodiment 7:

[0103] The main difference between Example 7 and Example 6 is that the added amounts of flora regulators and osmotic pressure regulators are different. In Example 7, the added amount of amino acids in the skin adhesive is 0.95%, the added amount of collagen is 0.40%, and the added amount of potassium chloride is 0.50%. For details, see the formula ratio below.

[0104] Table 4 Example 7 formulation ratio

[0105]

[0106] Specific preparation process (in mass percentage w%):

[0107] 1) Disperse 0.80% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 800,000-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at a stirring speed of 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0108] 2) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.38% ectoine, 0.22% dipotassium glycyrrhizinate, and 0.10% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0109] 3) After the pH stabilizes, add 0.35% sodium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0110] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0111] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0112] Embodiment 8:

[0113] The main difference between Example 8 and Example 1 is that the amount of microenvironment regulator added is different. In Example 8, the amount of microenvironment regulator ectoine added is 0.15%, and the amount of dipotassium glycyrrhizinate added is 0.12%. For details, see the following formula ratio.

[0114] Table 5 Example 8 formulation ratio

[0115]

[0116]

[0117] Specific preparation process (in mass percentage w%):

[0118] 1) Disperse 0.80% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 800,000-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at a stirring speed of 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0119] 2) adding 0.15% collagen, 1.15% sodium pyrrolidonecarboxylate, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.15% ectoine, 0.12% dipotassium glycyrrhizinate, and 0.08% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH, and determining that the pH is between 6.8-7.6, preferably 7.0-7.4;

[0120] 3) After the pH is stabilized, add 2.50% mannitol to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0121] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0122] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0123] Embodiment 9:

[0124] The main difference between Example 9 and Example 1 is that the amount of microenvironment regulator added is different. The amount of licorice extract added to the skin adhesive in Example 9 is 0.17%. For details, please see the following formula ratio.

[0125] Table 6 Example 9 formulation ratio

[0126]

[0127]

[0128] Specific preparation process (in mass percentage w%):

[0129] 1) Disperse 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0130] 2) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, 0.17% glycyrrhizic acid extract, and 0.08% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH, and determining that the pH is between 6.8-7.6, preferably 7.0-7.4;

[0131] 3) After the pH stabilizes, add 0.35% sodium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0132] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0133] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0134] Comparative Example 1:

[0135] In Comparative Example 1, no skin adhesive is added. For details, please refer to the formula ratio.

[0136] Table 7 Comparative Example 1 Formula Ratio

[0137]

[0138]

[0139] Specific preparation process (in mass percentage w%):

[0140] 4) Dispersing 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, stirring at a speed of 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0141] 5) adding 0.06% disodium hydrogen phosphate, 0.17% sodium dihydrogen phosphate, 0.40% ectoine, 0.20% dipotassium glycyrrhizinate, and 0.08% disodium ethylenediaminetetraacetic acid to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH, and determining that the pH is between 6.8-7.6, preferably 7.0-7.4;

[0142] 6) After the pH stabilizes, add 0.81% sodium chloride to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0143] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0144] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0145] Comparative Example 2:

[0146] In Comparative Example 2, no flora regulator is added. For details, please refer to the formula ratio.

[0147] Table 8 Comparative Example 2 Formula Ratio

[0148]

[0149] Specific preparation process (in mass percentage w%):

[0150] 7) Disperse 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, and stir at 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0151] 8) adding 0.15% dextran, 1.15% sodium pyrrolidonecarboxylate, 0.40% ectoine, and 0.20% dipotassium glycyrrhizinate to step 1), stirring at a stirring speed of 40-80 rpm until completely dissolved, measuring the pH to determine that the pH is between 6.8 and 7.6, preferably 7.0-7.4;

[0152] 9) After the pH stabilizes, add 2.91% mannitol to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0153] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0154] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0155] Comparative Example 3:

[0156] In comparative example 3, no microenvironment regulator is added, and the specific details are shown in the formula ratio.

[0157] Table 9 Comparative Example 3 Formula Ratio

[0158]

[0159] Specific preparation process (in mass percentage w%):

[0160] 10) Dispersing 0.8% composite sodium hyaluronate (0.48% sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and 0.32% sodium hyaluronate with a molecular weight of 800,000-1.5 million Da) in 40-60% of the formula water, stirring at a speed of 80-120 rpm until completely dissolved and free of particles, to obtain a pre-dissolved gel;

[0161] 11) adding 1.15% sodium pyrrolidonecarboxylate, 0.15% collagen, and 0.10% disodium ethylenediaminetetraacetate to step 1), stirring at 40-80 rpm until completely dissolved, measuring pH, and determining that the pH is between 6.8-7.6, preferably 7.0-7.4;

[0162] 12) After the pH stabilizes, add 3.39% mannitol to step 2), and stir at a low speed of 40-50 rpm for 20 minutes;

[0163] 4) Add the remaining amount of water, evacuate, maintain the pressure at 0.05-0.06Mpa and continue stirring at a low speed of 40-50rpm until completely dissolved;

[0164] 5) The prepared material is completely dissolved, and the product is evenly dispersed without obvious bubbles. The preparation is completed and the product is filled into the container.

[0165] The composition ratios of the functional components in the above-mentioned embodiments and comparative examples are shown in Table 10.

[0166] Table 10 Formula ratio of Examples 1-9 and Comparative Examples 1-3

[0167]

[0168] Comparative Example 4:

[0169] The components of commercially available product A are sodium hyaluronate and phosphate buffer (disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, purified water).

[0170] Comparative Example 5:

[0171] The components of commercially available product B are sodium hyaluronate, carbomer, sodium ethyl paraben, sodium propyl paraben, flavoring agent and purified water.

[0172] Comparative Example 6:

[0173] The commercially available product C consists of sodium hyaluronate, carbomer 980, glycerin, triethanolamine, purified water, citric acid and sodium citrate.

[0174] Comparative Example 7:

[0175] The commercially available product D consists of sodium hyaluronate, glycerin, phenoxyethanol, hydroxyethyl cellulose, and purified water.

[0176] The effects of the above-mentioned examples and comparative examples were tested by volunteers as follows:

[0177] Volunteer recruitment and processing process:

[0178] 80 female volunteers were recruited. All of them had non-chronic skin wounds after facial laser, photorejuvenation, acid peel and micro-plastic surgery. All volunteers had no other diseases. The volunteers were aged 28-35 years old, with an average age of 31 years old.

[0179] All volunteers were given CM 825 Skin Moisture Tester detects the moisture content of the skin stratum corneum.

[0180] Before the operation, 80 volunteers were disinfected with iodine.

[0181] After facial laser, photorejuvenation, acid peel and micro plastic surgery were performed on 80 volunteers, each of whom was divided into groups of 5, and the example and comparative example samples were used as units.

[0182] The volunteers were tested for wound skin moisturizing performance at 6h, 12h, and 24h after using the product.

[0183] Test Example 1 Wound Skin Moisturizing Performance Test

[0184] Use before surgery, 6h, 12h, 24h The CM 825 skin moisture tester was used to test the moisture content of the wound skin, and the average value was taken by group. The results are shown in Table 11.

[0185] Table 11. Skin moisture content of volunteers

[0186]

[0187]

[0188] It can be seen from Table 11 that Examples 1-9 are superior to Comparative Examples 1-3 in moisturizing the wound skin within 24 hours, and are significantly better than Comparative Examples 4-7.

[0189] Test Example 2 Film-forming Adhesion Performance Test

[0190] The film-forming adhesion of the wound skin of Examples 1-9, Comparative Example 1, and Comparative Examples 4-7 was tested at 6h, 12h, and 24h to determine the film-forming adhesion performance of the Examples and Comparative Examples. The results are shown in Table 12.

[0191] Table 12. Film Adhesion to Volunteer Skin

[0192]

[0193] Note: ★★★★ represents excellent film-forming adhesion, ★★★ represents good film-forming adhesion, ★★ represents poor film-forming adhesion, and ★ represents poor film-forming adhesion.

[0194] It can be seen from Table 12 that the film-forming adhesion of Examples 1-9 to the wound skin within 24 hours is significantly better than that of Comparative Examples 1 and Comparative Examples 4-7.

[0195] Test Example 3 Wound Skin Microbial Detection

[0196] At 6h, 12h, and 24h, sterile cotton swabs were used to sample the wound skin of Examples 1-9 and Comparative Examples 2, 4, 6, and 7, and microbial culture was performed to determine the number of microbial colonies in the Examples and Comparative Examples. The results are shown in Table X.

[0197] Table 13. Number of bacterial colonies on the skin of volunteers

[0198]

[0199] It can be seen from Table 13 that the colony count of Examples 1-9 on the wound skin within 24 hours is significantly less than that of Comparative Examples 2, 4, 6, and 7.

[0200] Test Example 4 Wound Skin Microbial Detection

[0201] At 24 hours, a questionnaire survey was conducted on the volunteers of Examples 1-9 and Comparative Examples 3, 4, 6 and 7 to inquire whether there were any adverse reactions within 6-24 hours. The results are shown in Table 14.

[0202] Table 14 Questionnaire survey content and evaluation criteria

[0203]

[0204]

[0205] Table 15 Questionnaire score table

[0206]

[0207] Note: The higher the score, the less friendly the wound surface is to the skin.

[0208] It can be seen from Table 15 that the discomfort and adverse reactions in Examples 1-9 with the addition of microenvironment regulators within 24 hours were significantly less than those in Comparative Examples 3-7.

[0209] Of course, the above description is only a preferred embodiment of the present invention, and the present invention is not limited to the above embodiments. It should be noted that all equivalent substitutions and obvious deformation forms made by any technician familiar with the field under the guidance of this specification fall within the essential scope of this specification and should be protected by the present invention.

Claims

1. A skin non-chronic wound repair dressing, It is characterized in that By mass fraction, it includes the following ingredients: Compound sodium hyaluronate 0.1-3.0%, Skin adhesive 0.5-5.0%, Bacteria flora regulator 0.1-2.0%, Microenvironment regulator 0.1-3.0%, Osmotic pressure regulator 0.5-9.0%, The balance is water.

2. The skin non-chronic wound repair dressing according to claim 1, It is characterized in that The composite sodium hyaluronate is prepared by mixing sodium hyaluronate with a molecular weight of 1.8-3.5 million Da and sodium hyaluronate with a molecular weight of 800,000-1.5 million Da in a ratio of 1-5:1-2.

3. The skin non-chronic wound repair dressing according to claim 2, It is characterized in that The ratio of the 1.8-3.5 million Da molecular weight sodium hyaluronate to the 800,000-1.5 million Da molecular weight sodium hyaluronate is 2-3:1-2.

4. The skin non-chronic wound repair dressing according to claim 3, It is characterized in that The ratio of the 1.8-3.5 million Da molecular weight sodium hyaluronate to the 800,000-1.5 million Da molecular weight sodium hyaluronate is 1.5:

1.

5. The skin non-chronic wound repair dressing according to claim 2, It is characterized in that The mass fraction of the composite sodium hyaluronate is 0.5-1.5%.

6. The skin non-chronic wound repair dressing according to claim 1, It is characterized in that pH is 6.8-7.

6.

7. The skin non-chronic wound repair dressing according to claim 1, It is characterized in that The osmotic pressure is 270mOsmol / kg~350mOsmol / kg.

8. A method for preparing the skin non-chronic wound repair dressing according to claim 1, It is characterized in that Includes steps: 1) dissolving composite sodium hyaluronate; 2) Add skin adhesive, flora regulator, and microenvironment regulator and dissolve completely; 3) adding an osmotic pressure regulator to step 2) and stirring to dissolve; 4) Add the remaining amount of water and stir under vacuum until completely dissolved.

9. The method for preparing the skin non-chronic wound repair dressing according to claim 8, It is characterized in that The vacuum stirring conditions are: 0.05-0.06Mpa pressure maintenance and 40-50rpm low speed stirring.

10. Application of a skin non-chronic wound repair dressing, Its characteristics are that It is used for the care of superficial wounds, small wounds, abrasions, first-degree or shallow second-degree burn wounds, facial laser, photorejuvenation, fruit acid peels, non-chronic wounds and surrounding skin after micro-plastic surgery.

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