An epidermal repair gel dressing and method of making same

Abstract

The present application provides a kind of epidermis repair gel dressings and its preparation method, it is related to dressing field.The epidermis repair gel dressings includes repair liquid, 100 parts of the repair liquid includes composite sodium hyaluronate 0.1-0.3 parts, carbomer 0.02-0.06 parts, glycerol 1-4 parts, pentanediol 1-3 parts, composite acid 0.05-0.1 parts, composite peptide 0.01-0.03 parts and the balance purified water by weight parts;The composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate and sodium hyaluronate crosslinked polymer;The composite acid is prepared from ursolic acid, hydroxyl asiatic acid, lipoic acid;The composite peptide is prepared from thirteen peptides and palmitoyl pentapeptide-3.The epidermis repair gel dressing of the present application has better repair effect on acne lesions, not only inhibits active propionibacterium acnes, but also can reduce the expression of inflammatory factors, can deeply repair damaged basal structure, maximumly reduce the degree of acne lesions, and restore to close normal skin.

Description

Technical Field

[0001] This invention relates to the field of dressings, and in particular to an epidermal repair gel dressing and its preparation method. Background Technology

[0002] Acne is a chronic inflammatory skin disease that widely affects the hair follicles and sebaceous glands, especially common on the face, chest, and back—areas with high sebum secretion. Depending on the severity, acne lesions can present as comedones, inflammatory papules, pustules, nodules, cysts, and other forms. After acne heals, persistent or even lifelong erythema and pigmentation often remain on the skin, causing long-term cosmetic distress. The pathogenesis of acne is complex, with inflammatory responses caused by Propionibacterium acnes (the main pathogen) and Staphylococcus aureus playing a crucial role. Acne can be classified into mild, moderate, and severe types, each causing varying degrees of skin damage.

[0003] To promote the repair of damaged skin, epidermal repair gel dressings have emerged. However, traditional wound dressings, such as gauze, plasters, and film dressings, while supporting wound healing, also have many shortcomings, such as poor breathability, poor fit, and easy damage to newly formed tissue during dressing changes. Especially for the repair of severe skin lesions such as acne, existing gel dressings on the market are often ineffective and cannot meet the needs of clinicians and patients. Therefore, developing an epidermal repair gel dressing with better repair efficacy, higher safety, and greater comfort is particularly important. Summary of the Invention

[0004] In view of this, the present invention proposes an epidermal repair gel dressing and its preparation method.

[0005] The technical solution of this invention is implemented as follows: an epidermal repair gel dressing, the epidermal repair gel dressing comprising a repair solution, wherein, by weight, 100 parts of the repair solution comprises 0.1-0.3 parts of composite sodium hyaluronate, 0.02-0.06 parts of carbomer, 1-4 parts of glycerin, 1-3 parts of pentylene glycol, 0.05-0.1 parts of a composite acid, 0.01-0.03 parts of a composite peptide, and the balance being purified water; the composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate, and a sodium hyaluronate cross-linked polymer; the composite acid is prepared from ursolic acid, hydroxyasiatic acid, and lipoic acid; and the composite peptide is prepared from decadecapeptide and palmitoyl pentapeptide-3.

[0006] Furthermore, by weight, 100 parts of the repair solution comprise 0.2 parts of compound sodium hyaluronate, 0.04 parts of carbomer, 2.0 parts of glycerin, 2.0 parts of pentylene glycol, 0.08 parts of compound acid, 0.02 parts of compound peptide, and the remainder purified water.

[0007] Furthermore, the composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer in a mass ratio of 1:0.2-0.4:0.6-0.8.

[0008] Furthermore, the composite acid is prepared from ursolic acid, hydroxyasiatic acid, and thioctic acid in a mass ratio of 1:0.3-0.5:0.5-0.7.

[0009] Furthermore, the complex peptide is prepared from a mass ratio of 2 to 4:1 of decacapeptide and palmitoyl pentapeptide-3.

[0010] This invention also provides a method for preparing an epidermal repair gel dressing, comprising the following steps:

[0011] (1) Mix sodium hyaluronate, carbomer and compound acid with glycerin to obtain mixture 1; mix compound peptide with pentylene glycol to obtain mixture 2;

[0012] (2) Add purified water and start stirring. Add mixture 1 and heat while stirring.

[0013] (3) Keep the rotation speed constant, cool down, add mixture 2, keep warm and stir to obtain gel dressing.

[0014] In the next step (2), purified water is added and the stirring speed is 35-45 r / min.

[0015] Further, in step (2), heating and stirring specifically involves heating to 75-85℃ and then stirring for 10-50 minutes.

[0016] Further, in step (3), the temperature is lowered to 35-45℃.

[0017] Furthermore, in step (3), the heat preservation and stirring time is 8-12 minutes.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] This invention's epidermal repair gel dressing uses a composite sodium hyaluronate prepared from sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer; a composite acid prepared from ursolic acid, hydroxyasiatic acid, and lipoic acid; and a composite peptide prepared from decadecapeptide and palmitoyl pentapeptide-3. Combined with carbomer, glycerin, and pentylene glycol, it prepares a repair solution with good repair effects on acne lesions. It not only inhibits the activity of Propionibacterium acnes but also reduces the expression of inflammatory factors, deeply repairs the damaged basal structure, minimizes the severity of acne lesions, and restores skin to near-normal levels. Furthermore, this invention's epidermal repair gel dressing has good safety and excellent user comfort. This invention employs a composite sodium hyaluronate prepared from sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer, which better reduces the expression of pro-inflammatory factors, alleviates erythema in acne lesions, and synergistically enhances the repair effect. The invention also employs a composite acid prepared from ursolic acid, asiatic acid, and lipoic acid, which better inhibits the activity of Propionibacterium acnes and enhances the repair effect. Furthermore, the invention utilizes a composite peptide prepared from decacapeptide and palmitoyl pentapeptide-3, which better remodels the damaged basement membrane band structure, inhibits scar formation, and further enhances the repair effect. Detailed Implementation

[0020] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0021] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0022] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0023] Example 1

[0024] An epidermal repair gel dressing, comprising a repair solution, a dressing, and an anti-adhesive film patch, wherein the dressing is made of non-woven fabric; by weight, 100 parts of the repair solution comprises 0.2 parts of compound sodium hyaluronate, 0.04 parts of carbomer, 2.0 parts of glycerin, 2.0 parts of pentylene glycol, 0.08 parts of compound acid, 0.02 parts of compound peptide, and the balance being purified water;

[0025] The above-mentioned composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer in a mass ratio of 1:0.3:0.7.

[0026] The above-mentioned composite acid was prepared from ursolic acid, hydroxyasiatic acid and thioctic acid in a mass ratio of 1:0.4:0.6.

[0027] The above-mentioned complex peptide was prepared by combining decacapeptide and palmitoyl pentapeptide-3 in a mass ratio of 3:1.

[0028] The preparation method of the above-mentioned epidermal repair gel dressing includes the following steps:

[0029] (1) Mix the compound sodium hyaluronate, carbomer and compound acid with glycerin to obtain mixture 1; mix the compound peptide with pentylene glycol to obtain mixture 2;

[0030] (2) Add purified water and start stirring at 40±5 r / min. Add mixture 1, heat to 80±5℃ and stir for 30 min.

[0031] (3) Keep the rotation speed constant, cool down to 40±5℃, add mixture 2, keep warm and stir for 10 minutes to obtain gel dressing.

[0032] Example 2

[0033] An epidermal repair gel dressing, comprising a repair solution, a dressing, and an anti-adhesive film patch, wherein the dressing is made of non-woven fabric; by weight, 100 parts of the repair solution comprises 0.1 parts of compound sodium hyaluronate, 0.06 parts of carbomer, 3.0 parts of glycerin, 1.5 parts of pentylene glycol, 0.05 parts of compound acid, 0.03 parts of compound peptide, and the balance being purified water;

[0034] The composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer in a mass ratio of 1:0.2:0.8.

[0035] The composite acid is prepared from ursolic acid, hydroxyasiatic acid, and thioctic acid in a mass ratio of 1:0.5:0.5.

[0036] The complex peptide was prepared from a mass ratio of 2:1 of decacapeptide and palmitoyl pentapeptide-3.

[0037] The preparation method of the above-mentioned epidermal repair gel dressing includes the following steps:

[0038] (1) Mix the compound sodium hyaluronate, carbomer and compound acid with glycerin to obtain mixture 1; mix the compound peptide with pentylene glycol to obtain mixture 2;

[0039] (2) Add purified water and start stirring at 40±5 r / min. Add mixture 1, heat to 80±5℃ and stir for 30 min.

[0040] (3) Keep the rotation speed constant, cool down to 40±5℃, add mixture 2, keep warm and stir for 10 minutes to obtain gel dressing.

[0041] Example 3

[0042] An epidermal repair gel dressing, comprising a repair solution, a dressing, and an anti-adhesive film patch, wherein the dressing is made of non-woven fabric; by weight, 100 parts of the repair solution comprises 0.3 parts of compound sodium hyaluronate, 0.02 parts of carbomer, 4.0 parts of glycerin, 1.0 part of pentylene glycol, 0.1 parts of compound acid, 0.01 parts of compound peptide, and the balance being purified water;

[0043] The composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer in a mass ratio of 1:0.4:0.6.

[0044] The composite acid is prepared from ursolic acid, hydroxyasiatic acid, and thioctic acid in a mass ratio of 1:0.3:0.7.

[0045] The complex peptide was prepared from a mass ratio of 4:1 of decacapeptide and palmitoyl pentapeptide-3.

[0046] The preparation method of the above-mentioned epidermal repair gel dressing includes the following steps:

[0047] (1) Mix the compound sodium hyaluronate, carbomer and compound acid with glycerin to obtain mixture 1; mix the compound peptide with pentylene glycol to obtain mixture 2;

[0048] (2) Add purified water and start stirring at 40±5 r / min. Add mixture 1, heat to 80±5℃ and stir for 30 min.

[0049] (3) Keep the rotation speed constant, cool down to 40±5℃, add mixture 2, keep warm and stir for 10 minutes to obtain gel dressing.

[0050] Comparative Example 1

[0051] The main difference from Example 1 is that the composite sodium hyaluronate does not contain sodium hyaluronate cross-linked polymer. The composite sodium hyaluronate is composed of sodium hyaluronate and hydrolyzed sodium hyaluronate; that is, the composite sodium hyaluronate is composed of sodium hyaluronate and hydrolyzed sodium hyaluronate in a 1:1 mass ratio. Other components, dosages, and preparation processes are the same as in Example 1.

[0052] Comparative Example 2

[0053] The main difference from Example 1 is that the composite acid does not contain hydroxyasiatic acid, and is prepared from ursolic acid and lipoic acid; that is, the composite acid is prepared from ursolic acid and lipoic acid in a mass ratio of 1:1. Other components, dosages, and preparation processes are the same as in Example 1.

[0054] Comparative Example 3

[0055] The main difference from Example 1 is that the composite acid does not contain lipoic acid; instead, it is prepared from ursolic acid and asiatic acid. Specifically, the composite acid is prepared from ursolic acid and asiatic acid in a 1:1 mass ratio. Other components, dosages, and preparation processes are the same as in Example 1.

[0056] Comparative Example 4

[0057] The main difference from Example 1 is that palmitoyl pentapeptide-3 in the complex peptide is replaced with palmitoyl tripeptide-5, meaning the complex peptide is prepared from a 3:1 mass ratio of decacapeptide and palmitoyl tripeptide-5. Other components, amounts, and preparation processes are the same as in Example 1.

[0058] Experimental Example 1: Rat Experiment

[0059] Healthy SPF-grade male Wistar rats, weighing 180–220 g, were selected. Ten rats were randomly selected as the normal control group, and the rest were used as the model group. A rat auricular complex acne model was prepared according to the "Specifications for the Preparation of Animal Acne Models," specifically by applying 100% oleic acid (1 cm × 1 cm area) to the duct opening on the inner surface of the right ear of each rat, 0.3 mL per rat, once daily. Every other day, Propionibacterium acnes bacterial solution (6 × 10⁻⁶) was injected intradermally into the auricular skin of the rats. 7 50 μL (cfu / mL) was administered once daily. Model construction continued for 14 days. Inoculation was stopped when pustular cysts were visible to the naked eye. Two model rats were randomly selected, and the left auricle tissue was stained with hematoxylin and eosin (HE). The success of the model was judged based on the appearance of skin lesions and pathological morphological changes in the auricle. The model rats were randomly divided into model group, positive control group, and experimental groups 1-7, with 10 rats in each group.

[0060] Administration method: The dosage was determined based on the rat auricle model area. Specifically, experimental groups 1-7 were treated with 0.25g of the repair solution (50mg / g) from Examples 1-3 and Comparative Examples 1-4, respectively. The positive control group received 0.25g of clindamycin hydrochloride gel (10mg / g). The administration site was the right auricle of all rats, once daily for 28 consecutive days. The model group received 0.25g of gel matrix at the same location. The normal group received no treatment. 24 hours after the last administration, the rats were fasted but allowed free water for 12 hours. The rats were disinfected with 75% / v / v ethanol and anesthetized with 0.3% wt sodium pentobarbital intraperitoneally. The auricle area was fully exposed, and fresh auricle tissue was quickly harvested, partially placed in a glutaraldehyde culture dish, and cut into 1mm pieces. 3 Small tissue samples were fixed with glutaraldehyde at room temperature for 2 hours and then stored at 4°C. A portion of auricular tissue was then rinsed with physiological saline and fixed with 4% paraformaldehyde. The remaining auricular tissue was flash-frozen in liquid nitrogen and stored at -80°C.

[0061] Rat auricular skin lesion scoring: After repair, the severity of auricular skin lesions in each group of rats was scored, using four levels: auricular swelling, skin color change, epidermal keratinization, and papules / pustules. Scores of 0-3 represent different degrees of severity: none, mild, moderate, and severe. The total scores for each group were calculated and compared with the model group to determine the repair rate.

[0062] Repair rate = (Total score of model group - Total score of experimental group or positive control group) / Total score of model group * 100%

[0063] Table 1 Scoring table for skin lesions in rat auricle tissue

[0064] Fraction Swelling of auricular tissue Skin color change Epidermal keratinization papules and pustules 0 points none none none none 1 point Mild Mild Mild Mild 2 points moderate moderate moderate moderate 3 points Severe Severe Severe Severe

[0065] Table 2. Severity of skin lesions in the auricle tissue of rats in each group after repair.

[0066] Total score of 10 rats Repair rate Model group 118 -- Positive control group 40 66.1％ Example 1 3 97.5％ Example 2 8 93.2％ Example 3 5 95.8％ Comparative Example 1 10 91.5％ Comparative Example 2 12 89.8％ Comparative Example 3 13 89.0％ Comparative Example 4 15 87.3％

[0067] The results showed that in the normal group, the swelling of the auricle tissue, skin color change, epidermal keratinization, and papule-pustule scores of the rats were all 0. In the model group, the swelling of the auricle tissue, skin color change, epidermal keratinization, and papule-pustule scores of the rats were mostly severe. The repair solutions in Examples 1-3 showed good repair effects on complex acne, greatly reducing skin lesions and restoring the condition to near normal levels, while the repair effects in Comparative Examples 1-4 were not ideal.

[0068] Test Example 2 Safety Experiment

[0069] The epidermal repair gel dressings prepared in Examples 1-3 were subjected to animal skin irritation tests, skin sensitization tests, and in vitro cytotoxicity tests. The results showed that they were non-irritating, non-sensitizing, and non-toxic, and had good safety.

[0070] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A skin repair gel dressing, characterized in that, The epidermal repair gel dressing includes a repair solution. By weight, 100 parts of the repair solution include 0.1-0.3 parts of compound sodium hyaluronate, 0.02-0.06 parts of carbomer, 1-4 parts of glycerin, 1-3 parts of pentylene glycol, 0.05-0.1 parts of compound acid, 0.01-0.03 parts of compound peptide, and the balance being purified water. The compound sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer in a mass ratio of 1:0.2-0.4:0.6-0.

8. The compound acid is prepared from ursolic acid, hydroxyasiatic acid, and lipoic acid in a mass ratio of 1:0.3-0.5:0.5-0.

7. The compound peptide is prepared from decacapeptide and palmitoyl pentapeptide-3 in a mass ratio of 2-4:

1.

2. The epidermal repair gel dressing according to claim 1, characterized in that, By weight, 100 parts of the repair solution comprise 0.2 parts of compound sodium hyaluronate, 0.04 parts of carbomer, 2 parts of glycerin, 2 parts of pentylene glycol, 0.08 parts of compound acid, 0.02 parts of compound peptide, and the remainder purified water.

3. The method for preparing the epidermal repair gel dressing according to any one of claims 1 to 2, characterized in that, Includes the following steps: (1) Mix sodium hyaluronate, carbomer and compound acid with glycerol to obtain mixture 1; mix compound peptide with pentylene glycol to obtain mixture 2; (2) Add purified water and start stirring. Add mixture 1 and heat while stirring. (3) Keep the rotation speed constant, cool down, add mixture 2, keep warm and stir to obtain gel dressing.

4. The method for preparing the epidermal repair gel dressing according to claim 3, characterized in that, Step (2): Add purified water and start stirring at a speed of 35-45 r / min.

5. The method for preparing the epidermal repair gel dressing according to claim 3, characterized in that, Step (2), heating and stirring, specifically involves heating to 75-85℃ and then stirring for 10-50 minutes.

6. The method for preparing the epidermal repair gel dressing according to claim 3, characterized in that, Step (3): Cool down to 35-45℃.

7. The method for preparing the epidermal repair gel dressing according to claim 3, characterized in that, Step (3), the heat preservation and stirring time is 8-12 minutes.