Epidermal repair gel dressing and preparation method thereof

Abstract

The invention provides an epidermal repair gel dressing and a preparation method thereof, and relates to the field of dressings. The epidermal repair gel dressing comprises repair liquid, and 100 parts by weight of the repair liquid comprises 0.1 to 0.3 part by weight of composite sodium hyaluronate, 0.02 to 0.06 part by weight of carbomer, 1 to 4 parts by weight of glycerin, 1 to 3 parts by weight of pentanediol, 0.05 to 0.1 part by weight of composite acid, 0.01 to 0.03 part by weight of composite peptide and the balance of purified water. The composite sodium hyaluronate is prepared from sodium hyaluronate, hydrolyzed sodium hyaluronate and a sodium hyaluronate cross-linked polymer; the composite acid is prepared from ursolic acid, madecassic acid and lipoic acid; the composite peptide is prepared from tridecapeptide and palmitoyl pentapeptide-3. The epidermis repair gel dressing has a good repair effect on acne skin lesions, not only inhibits activities of propionibacterium acnes and the like, but also can reduce expression of inflammatory factors, deeply repair damaged basal structures, maximally reduce the degree of the acne skin lesions and restore the skin to be close to normal skin.

Description

Technical Field

[0001] The invention relates to the field of dressings, and in particular to an epidermal repair gel dressing and a preparation method thereof. Background Art

[0002] Acne is a chronic inflammatory skin disease that occurs widely in the hair follicles and sebaceous glands, and is particularly common in areas with vigorous sebaceous gland secretion such as the face, chest and back. Depending on the severity of acne, the skin lesions of acne can present in various forms such as comedones, inflammatory papules, pustules, nodules, cysts, etc. After acne is cured, persistent or even lifelong erythema and pigmentation are often left on the skin, causing long-term cosmetic problems for patients. The pathogenesis of acne is complex, among which the inflammatory response caused by Propionibacterium acnes (as the main pathogenic bacteria) and Staphylococcus aureus plays a vital role in the pathogenesis of acne. Acne can be divided into three types: mild, moderate and severe, and each type can cause skin damage to varying degrees.

[0003] In order to promote the repair of damaged epidermis, epidermal repair gel dressings came into being. However, while traditional wound dressings, such as gauze, plasters, and film-type dressings, support wound healing, they also have many shortcomings, such as poor air permeability, poor fit, and easy damage to new tissue during replacement. Especially for the repair of severe skin lesions such as severe acne, the existing gel dressings on the market often have poor effects and cannot meet the needs of clinicians and patients. Therefore, it is particularly important to develop an epidermal repair gel dressing with better repair effects, higher safety, and comfort. Summary of the invention

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

[0005] The technical solution of the present invention is achieved as follows: an epidermal repair gel dressing, the epidermal repair gel dressing comprising a repair solution, wherein 100 parts of the repair solution comprise, by weight, 0.1-0.3 parts of composite sodium hyaluronate, 0.02-0.06 parts of carbomer, 1-4 parts of glycerol, 1-3 parts of pentanediol, 0.05-0.1 parts of composite acid, 0.01-0.03 parts of composite peptide and the remainder of purified water; the composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate and sodium hyaluronate cross-linked polymer; the composite acid is prepared from ursolic acid, madecassic acid and lipoic acid; the composite peptide is prepared from tridecapeptide and palmitoyl pentapeptide-3.

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

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

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

[0009] Further, the composite peptide is prepared from tridecapeptide and palmitoyl pentapeptide-3 in a mass ratio of 2-4:1.

[0010] The present invention also provides a preparation method of the epidermal repair gel dressing, comprising the following steps:

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

[0012] (2) Add purified water to start stirring, add mixture 1, and heat and stir;

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

[0014] In further step (2), the rotation speed for starting stirring after adding purified water is 35-45 r / min.

[0015] Further, in step (2), the heating and stirring specifically are: after heating to 75-85 °C, keep warm and stir for 10-50 min.

[0016] Further, in step (3), cool down to 35-45 °C.

[0017] Further, in step (3), the time for keeping warm and stirring is 8-12 min

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

[0019] The epidermal repair gel dressing of the present invention 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, hydroxymagnolol, and lipoic acid; a composite peptide prepared from tridecapeptide and palmitoyl pentapeptide-3, combined with carbomer, glycerol, and pentylene glycol to prepare a repair solution, which has a good repair effect on acne lesions. It can not only inhibit the activity of Propionibacterium acnes, etc., but also reduce the expression of inflammatory factors, can deeply repair the damaged basal structure, minimize the degree of acne lesions, and restore to near-normal skin; moreover, the epidermal repair gel dressing of the present invention has good safety and good use comfort. Among them, the present invention uses a composite sodium hyaluronate prepared from sodium hyaluronate, hydrolyzed sodium hyaluronate, and sodium hyaluronate cross-linked polymer to better reduce the expression of pro-inflammatory factors, relieve the erythema reaction in the acne lesion area, and synergistically enhance the repair effect; the present invention uses a composite acid prepared from ursolic acid, hydroxymagnolol, and lipoic acid to better inhibit the activity of Propionibacterium acnes and enhance the repair effect at the same time; the present invention uses a composite peptide prepared from tridecapeptide and palmitoyl pentapeptide-3 to better reshape the damaged basement membrane zone structure, inhibit scar formation, and further enhance the repair effect. Detailed implementation manners

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

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

[0022] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can all be obtained from commercial channels.

[0023] Example 1

[0024] An epidermal repair gel dressing, which is composed of a repair solution, a dressing, and an anti-adhesive patch. The dressing is made of non-woven fabric; by weight, 100 parts of the repair solution includes 0.2 parts of composite sodium hyaluronate, 0.04 parts of carbomer, 2.0 parts of glycerol, 2.0 parts of pentylene glycol, 0.08 parts of composite acid, 0.02 parts of composite peptide, and the balance 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 is prepared from ursolic acid, hydroxymagnolol, and lipoic acid in a mass ratio of 1:0.4:0.6.

[0027] The above-mentioned composite peptide is prepared from tridecapeptide 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 sodium hyaluronate complex, carbomer, and complex acid evenly with glycerol to obtain mixture 1; mix complex peptide evenly with pentylene glycol to obtain mixture 2;

[0030] (2) Add purified water and start stirring at a speed of 40 ± 5 r / min. Add mixture 1 and heat to 80 ± 5 °C, then keep stirring for 30 min while maintaining the temperature;

[0031] (3) Keep the speed unchanged, cool down to 40 ± 5 °C, add mixture 2, and keep stirring for 10 min to obtain the gel dressing.

[0032] Example 2

[0033] An epidermal repair gel dressing, which is composed of a repair solution, a dressing, and an anti-adhesive patch. The dressing is made of non-woven fabric; by weight, 100 parts of the repair solution includes 0.1 part of sodium hyaluronate complex, 0.06 part of carbomer, 3.0 parts of glycerol, 1.5 parts of pentylene glycol, 0.05 part of complex acid, 0.03 part of complex peptide, and the balance of purified water;

[0034] The sodium hyaluronate complex 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 complex acid is prepared from ursolic acid, madecassic acid, and lipoic acid in a mass ratio of 1:0.5:0.5.

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

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

[0038] (1) Mix sodium hyaluronate complex, carbomer, and complex acid evenly with glycerol to obtain mixture 1; mix complex peptide evenly with pentylene glycol to obtain mixture 2;

[0039] (2) Add purified water and start stirring at a speed of 40 ± 5 r / min. Add mixture 1 and heat to 80 ± 5 °C, then keep stirring for 30 min while maintaining the temperature;

[0040] (3) Keep the speed unchanged, cool down to 40 ± 5 °C, add mixture 2, and keep stirring for 10 min to obtain the gel dressing.

[0041] Example 3

[0042] An epidermal repair gel dressing, which is composed of a repair solution, a dressing, and an anti-adhesive patch. The dressing is made of non-woven fabric. By weight, 100 parts of the repair solution include 0.3 parts of compound sodium hyaluronate, 0.02 parts of carbomer, 4.0 parts of glycerol, 1.0 parts of pentylene glycol, 0.1 parts of compound acid, 0.01 parts of compound peptide, and the balance of purified water.

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

[0044] The compound acid is prepared from ursolic acid, madecassic acid, and lipoic acid in a mass ratio of 1:0.3:0.7.

[0045] The compound peptide is prepared from tridecapeptide and palmitoyl pentapeptide-3 in a mass ratio of 4:1.

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

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

[0048] (2) Add purified water and start stirring at a speed of 40±5 r / min. Add mixture 1, heat to 80±5 °C, and then keep stirring for 30 min while maintaining the temperature.

[0049] (3) Keep the speed unchanged, cool down to 40±5 °C, add mixture 2, and keep stirring for 10 min to obtain the gel dressing.

[0050] Comparative Example 1

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

[0052] Comparative Example 2

[0053] The main difference from Example 1 is that the compound acid does not contain madecassic acid, and the compound acid is prepared from ursolic acid and lipoic acid; that is, the compound 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 those in Example 1.

[0054] Comparative Example 3

[0055] The main difference from Example 1 is that lipoic acid is not contained in the compound acid, and the compound acid is prepared from ursolic acid and asiatic acid; that is, the compound acid is prepared from ursolic acid and asiatic acid in a mass ratio of 1:1. Other components, dosages and preparation processes are the same as those in Example 1.

[0056] Comparative Example 4

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

[0058] Experimental Example 1 Rat Experiment

[0059] Healthy SPF-grade Wistar male rats with a body weight of 180 - 220 g were selected. Randomly select 10 rats as the normal group, and the rest are the model group. Refer to the "Preparation Specification of Acne Animal Model" to prepare a compound acne model on the auricles of rats, that is, apply 100% oleic acid on the inner side of the right ear of the rats at the catheter opening, with an area of 1 cm × 1 cm, 0.3 mL for each rat, once a day, and intradermally inject Propionibacterium acnes bacterium solution (6×10 7 cfu / mL) 50 μL into the auricles of the rats every other day. The model construction lasts for 14 days. When pustules and cysts can be seen with the naked eye, the inoculation is stopped. Randomly select two model rats, and perform HE staining on the left auricle tissue. Judge whether the model is successful according to the skin lesions on the auricle appearance and pathological morphological changes; randomly divide the model rats into a model group, a positive control group, and experimental groups 1 - 7, with 10 rats in each group.

[0060] Drug administration method: Administer drugs according to the area of the auricle model of the rats, that is, apply 0.25 g of the repair solutions of Examples 1 - 3 and Comparative Examples 1 - 4 (concentration: 50 mg / g) to experimental groups 1 - 7 respectively, and the positive control group is given 0.25 g of clindamycin hydrochloride gel (concentration: 10 mg / g); the drug administration site is the right auricle of the rats, once a day, for 28 consecutive days; the model group applies 0.25 g of the gel matrix at the same position; the normal group is not treated; 24 hours after the last drug administration, the rats are fasted but not watered for 12 hours, disinfected with 75% / v / v ethanol, anesthetized intraperitoneally with 0.3% wt sodium pentobarbital, the auricle part of the rats is fully exposed, and fresh auricle tissue is quickly taken. Part of it is placed in a petri dish containing glutaraldehyde, cut into small tissues of 1 mm 3 in size, fixed at room temperature with glutaraldehyde for 2 hours, and then stored in a refrigerator at 4°C; then take part of the auricle tissue, rinse it with physiological saline, and fix it with 4% paraformaldehyde; the remaining auricle tissue is quickly frozen in liquid nitrogen and stored in a refrigerator at -80°C.

[0061] Rat auricle tissue skin lesion score: After repair, the severity of skin lesions in the auricle tissues of rats in each group was scored. The swelling degree, skin color change, epidermal keratinization degree, and papules and pustules of the auricle tissues were evaluated at four levels. 0-3 points represent different severities: none, mild, moderate, and severe. The total scores of each group were statistically analyzed, compared with the model group, and the repair rate was calculated.

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

[0063] Table 1 Rat auricle tissue skin lesion score table

[0064] Score Degree of auricle tissue swelling Skin color change Degree of 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 tissues 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 the scores of swelling degree, skin color change, epidermal keratinization degree, and papules and pustules in the auricle tissues of rats in the normal group were all 0 points. The scores of swelling degree, skin color change, epidermal keratinization degree, and papules and pustules in the auricle tissues of rats in the model group were mostly severe. The repair fluids of Examples 1-3 had a good repair effect on compound acne, greatly reducing skin lesions and restoring them to near the normal group, while the repair effects of Comparative Examples 1-4 were not ideal.

[0068] Experimental Example 2 Safety experiment

[0069] The epidermal repair gel dressings and repair fluids prepared in Examples 1-3 were respectively subjected to animal skin irritation test, skin sensitization test, and in vitro cytotoxicity test. The results showed no irritation, no sensitization, and no toxicity, and the safety was good.

[0070] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. An epidermal repair gel dressing, characterized in that: The epidermal repair gel dressing comprises a repair solution, wherein 100 parts of the repair solution comprise, by weight, 0.1-0.3 parts of composite sodium hyaluronate, 0.02-0.06 parts of carbomer, 1-4 parts of glycerol, 1-3 parts of pentanediol, 0.05-0.1 parts of composite acid, 0.01-0.03 parts of composite peptide and the remainder of purified water; the composite sodium hyaluronate is composed of sodium hyaluronate, hydrolyzed sodium hyaluronate and sodium hyaluronate cross-linked polymer; the composite acid is prepared from ursolic acid, madecassic acid and lipoic acid; the composite peptide is prepared from tridecapeptide and palmitoyl pentapeptide-3.

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

3. The epidermal repair gel dressing according to claim 1, characterized in that: 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.

4. The epidermal repair gel dressing according to claim 1, characterized in that: The composite acid is prepared from ursolic acid, madecassic acid and lipoic acid in a mass ratio of 1:0.3-0.5:0.5-0.

7.

5. The epidermal repair gel dressing according to claim 1, characterized in that: The composite peptide is prepared from tridecapeptide and palmitoyl pentapeptide-3 in a mass ratio of 2 to 4:

1.

6. The method for preparing the epidermal repair gel dressing according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) mixing composite sodium hyaluronate, carbomer and composite acid with glycerol to obtain a mixed solution 1; mixing the composite peptide with pentanediol to obtain a mixed solution 2; (2) Add purified water and start stirring, then add mixed solution 1, heat and stir; (3) Keep the speed unchanged, lower the temperature, add the mixed solution 2, and stir while keeping the temperature high to obtain a gel dressing.

7. The method for preparing the epidermal repair gel dressing according to claim 6, characterized in that: Step (2), add purified water and start stirring at a speed of 35-45 r / min.

8. The method for preparing the epidermal repair gel dressing according to claim 6, characterized in that: Step (2), heating and stirring specifically comprises: heating to 75-85° C., and then keeping warm and stirring for 10-50 minutes.

9. The method for preparing the epidermal repair gel dressing according to claim 6, characterized in that: Step (3), cooling to 35-45°C.

10. The method for preparing the epidermal repair gel dressing according to claim 6, characterized in that: Step (3), the heat preservation and stirring time is 8-12 minutes.