Dressing liquid, repair dressing and preparation method and use thereof

By reasonably comparing components such as carbomer, sodium hyaluronate, sodium alginate, tetrahydromethylpyrimidincarboxylic acid and β-glucan in the patch solution, the stability and safety problems of existing patch solutions after damp heat sterilization are solved, and the long-term stability and effectiveness of patch solutions without preservatives and antibacterial agents under high temperature conditions are achieved.

CN117357432BActive Publication Date: 2025-04-08SHAANXI BIO REGENERATIVE MEDICINE CO LTD

Patent Information

Application Number
CN202311286764.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2023-09-20
Filing Date
2023-10-07
Publication Date
2025-04-08
Estimated Expiration
2043-10-07

AI Technical Summary

Technical Problem

Existing medical patches are prone to damage during the damp heat sterilization process, resulting in product stability and safety issues. They often contain preservatives or antibacterial agents, which may have adverse effects on the skin.

Method used

Through the synergistic effect of components such as carbomer, sodium hyaluronate, sodium alginate, tetrahydromethylpyrimidincarboxylic acid and β-glucan, a patch solution without preservatives and antibacterial agents can be prepared, which can maintain the molecular weight and system stability of the active substance after high temperature, humidity and heat sterilization.

Benefits of technology

The long-term qualified sterility level of the patch solution under unstable conditions such as high temperature and shock is achieved, which reduces the possibility of wound infection and inflammation, and does not contain harmful substances, improving the safety and effectiveness of the product.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a patch, a repair patch, and a preparation method and use thereof, and relates to the field of skin care products. The raw materials of the patch of the present invention include the following components by weight: 0.01-1 parts of carbomer, 0.001-0.5 parts of sodium alginate, 0.001-0.6 parts of β-glucan, 0.02-1.5 parts of tetrahydromethylpyrimidine carboxylic acid, sodium hyaluronate, water, a moisturizer, a pH regulator and a thickener. Since carbomer, sodium hyaluronate, sodium alginate, tetrahydromethylpyrimidine carboxylic acid and β-glucan are added to the patch, each component synergizes to form an excellent physical barrier, and in the absence of a preservative, the prepared patch still has good microbial level stability, and can also effectively maintain the stability of the system, which helps to preserve it for a long time.
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Description

Technical Field

[0001] The invention belongs to the field of skin care products, and more specifically relates to a patch solution, a repair patch, and a preparation method and use thereof. Background Art

[0002] With the development and progress of society, people have new standards for the pursuit of beauty, and transdermal absorption technologies such as life mesotherapy matrix microneedles and water light needles are gradually accepted by people. Although the above-mentioned technologies can effectively improve the moisture and whitening of the skin, it is inevitable that the above-mentioned technologies will more or less cause minimally invasive damage to the skin, resulting in damage to the skin barrier at the minimally invasive site. In order to promote the skin at the minimally invasive site to recover as soon as possible, after implementing the above-mentioned technologies, it is often necessary to use sterile medical products such as medical patches to cover the minimally invasive site, so as to isolate the skin at the minimally invasive site from the outside world, so as to promote rapid repair of the skin. In addition, with the increase in people's outdoor travel activities, the number of people with skin damage due to light radiation and the like has increased, and patch products with the function of isolating the outside world and protecting the skin are also needed for repair.

[0003] In order to provide a suitable skin care environment, the patch often contains macromolecular substances such as sodium hyaluronate, gelatin, plant extracts and collagen that can moisturize and nourish the skin to improve the quality of skin care. At present, medical patches are mainly divided into two types: sterile and non-sterile. Non-sterile medical patches are usually made by adding preservatives or antibacterial agents. However, preservatives or antibacterial agents will increase the permeability of harmful substances in the skin, and preservatives and antibacterial agents will also cause dysbiosis of the skin surface flora; sterile medical patches are usually obtained by irradiation sterilization or moist heat sterilization. The irradiation method will reduce the molecular weight of macromolecular substances in the patch, making the medical patch products unable to play an effective role due to the destruction of the active ingredients, and it is easy to cause the safety of medical patch products to be unable to be guaranteed. Moist heat sterilization is a relatively mild method of sterilization in saturated steam, boiling water or circulating steam. Generally, moist heat sterilization at 121°C steam for 8 to 15 minutes is adopted to achieve the sterilization effect. However, some macromolecular substances are easily destroyed by high temperature and high pressure, which may lead to problems such as system instability or inability to maintain efficacy in the final product. For example, CN106139178A discloses that sodium hyaluronate itself is thermally unstable, and sodium hyaluronate degrades to a large extent during wet heat sterilization, resulting in a significant decrease in the molecular weight of the product. However, CN106139178A attempts to solve this problem by changing the sterilization method. The method disclosed is relatively complicated and is not conducive to large-scale industrialization compared to the mature wet heat sterilization method.

[0004] It can be seen that developing a sterile repair dressing solution that is free of irritating substances such as preservatives and antibacterial agents, and allowing the polymer materials contained therein to function stably and persistently, is of great significance in the field of skin repair. Summary of the invention

[0005] In view of the above-mentioned defects and problems of the prior art, the present invention develops a dressing liquid, a repair dressing containing the same, and a preparation method and use thereof.

[0006] The first aspect of the present invention provides a dressing liquid, wherein the raw materials of the dressing liquid include the following components, by weight: 0.01-1 part of carbomer, 0.001-0.5 part of sodium alginate, 0.001-0.6 part of β-glucan, 0.02-1.5 parts of tetrahydromethylpyrimidine carboxylic acid (EC), sodium hyaluronate, water, a moisturizer, a pH regulator and a thickener.

[0007] Optionally, in parts by weight, the carbomer is 0.05-0.3 parts, the sodium alginate is 0.08-0.4 parts, and the β-glucan is 0.05-0.2 parts.

[0008] Optionally, the amount of the tetrahydromethylpyrimidine carboxylic acid is 0.1-0.3 parts.

[0009] The inventors found that by the appropriate amount of sodium hyaluronate, sodium alginate, β-glucan, tetrahydromethylpyrimidine carboxylic acid and carbomer and thickener, the dressing solution of the present invention can still basically maintain the molecular weight of the active substance (such as sodium hyaluronate) after high temperature and moist heat sterilization, and the product system after high temperature and moist heat sterilization can maintain good stability, and can maintain a qualified sterile level for a long time under unstable conditions such as high temperature and shock. This may be related to the molecular structure, viscosity and ionization properties of carbomer, sodium hyaluronate, sodium alginate, tetrahydromethylpyrimidine carboxylic acid and β-glucan. Only when the above-mentioned raw materials cooperate with each other, each substance can fully play its role. Lack of any one or inappropriate addition will cause the stability of the composition as a whole (such as microbial level stability and active substance molecular weight or content stability) to be greatly reduced.

[0010] Optionally, the moisturizer includes glycerin and / or propylene glycol; the thickener includes hydroxyethyl cellulose and / or xanthan gum; the carbomer is selected from at least one of carbomer homopolymer A, carbomer homopolymer B and carbomer homopolymer C; and the pH adjuster is selected from sodium hydroxide or sodium phosphate.

[0011] Optionally, the viscosity of the dressing solution is ≥300 mPa·s.

[0012] A patch with appropriate viscosity can not only improve the adhesion between the patch and the skin, making it less likely for the patch to fall off where it is applied to the skin, thereby enabling it to function as a skin barrier for a long time, but it can also make the user feel comfortable where it is applied, thereby improving the applicability and popularity of the entire patch.

[0013] Another aspect of the present invention provides a method for preparing the above-mentioned dressing solution, comprising the following steps:

[0014] (1) Add carbomer to water and soak it for 8 to 24 hours to obtain solution A;

[0015] (2) adding sodium hyaluronate, sodium alginate and thickener to the moisturizer while stirring, and continuing stirring for 20-30 minutes to obtain solution B;

[0016] (3) Mixing solution A and solution B, heating at 50-90° C. for 20-30 min to obtain solution C;

[0017] (4) When the temperature of solution C drops to 50-65° C., add β-glucan and tetrahydromethylpyrimidine carboxylic acid, stir for 10-25 minutes, and adjust the pH of solution C to 5.0-8.0 with a pH adjuster; keep stirring, continue to cool until the temperature of solution C is ≤45° C., and discharge the material to obtain the dressing solution;

[0018] (5) After step (4), the dressing solution is sterilized by wet heat sterilization, the temperature of wet heat sterilization is 115-125° C., and the sterilization time is 10-30 min.

[0019] Soaking carbomer in water for a suitable period of time helps to fully disperse the carbomer in the solution and allows its structure to fully stretch in the solution so that its performance can be fully exerted.

[0020] Moist heat sterilization can reduce the risk of smaller viruses and mycoplasmas not being completely filtered out, which helps to greatly improve product safety. Compared with irradiation sterilization and dry heat sterilization, moist heat sterilization is less likely to cause degradation of raw materials, thus helping to fully exert the effects of various substances.

[0021] On the other hand, the present invention further provides a repair patch, which comprises a carrier and the above-mentioned dressing liquid. The carrier can be a dressing material commonly used in the art (e.g., a commercially available film towel for facial mask). It is understandable that the repair patch can be formed by mixing the dressing liquid prepared by the present invention with a commercially available film towel. In addition to being prepared as a dressing, the application form of the dressing liquid of the present invention can also be a suitable dosage form such as an aqueous solution, a spray, etc.; in addition, the dressing liquid of the present invention can be provided to a subject in need through a suitable medical device carrier, and is not limited to the content disclosed in the present invention.

[0022] Another aspect of the present invention further provides the use of the above-mentioned dressing solution in preparing a product for repairing skin barrier damage; preferably, the skin barrier damage is skin barrier damage after medical aesthetics. Correspondingly, the present invention also provides the use of the above-mentioned dressing solution for treating skin barrier damage after medical aesthetics.

[0023] It can be understood that the dressing liquid prepared by the present invention can be used to keep the wound surface moist, promote wound healing and skin repair, and can also be used for the repair and care of small wounds, abrasions, dermatitis eczema, sensitive skin, hormone-dependent dermatitis, acne and other barrier-damaged skin, as well as wounds after laser / photon / fruit acid / micro-plastic surgery.

[0024] In summary, the present invention has at least one of the following beneficial effects:

[0025] In the dressing solution of the present invention, due to the addition of appropriate amounts of carbomer, sodium hyaluronate, sodium alginate, tetrahydromethylpyrimidine carboxylic acid and β-glucan, each component synergizes to form an excellent physical barrier and microbial barrier, and in the absence of a preservative, the prepared dressing solution still has good microbial level stability, can be maintained for a long time, and can effectively reduce the possibility of wound infection and inflammation. Sodium hyaluronate, carbomer, sodium alginate, tetrahydromethylpyrimidine carboxylic acid and β-glucan are combined to effectively maintain the stability of the system and avoid the damage caused by moist heat sterilization to the functional macromolecular substances in the product. The dressing solution of the present invention has excellent efficacy in terms of safety and effectiveness. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below.

[0027] Figure 1 This is a schematic diagram of the in vitro cytotoxicity test results of Example 1. DETAILED DESCRIPTION

[0028] The present invention is further described below in conjunction with examples. It should be understood that the examples are only used to further illustrate and explain the present invention, and are not intended to limit the present invention.

[0029] Unless otherwise defined, the technical terms and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Although similar or identical methods and materials as those described herein may be used in experiments or practical applications, the materials and methods are described herein below. In the event of a conflict, the present specification including the definitions therein shall prevail. In addition, the materials, methods and examples are provided for illustration only and are not intended to be limiting.

[0030] The test methods, detection methods and conventional experimental reagent preparation methods used in the embodiments of the present invention are all in accordance with conventional operations in the art unless otherwise specified.

[0031] In order to facilitate the description of the technical solution of the present invention, the following materials and steps are described before starting the experiment of the present invention:

[0032] (1) The moisturizing agent in the present invention can be any moisturizing agent that can promote the dissolution of sodium hyaluronate and sodium alginate. As an example, the moisturizing agent in the following embodiments and comparative examples is a mixture of glycerol and propylene glycol.

[0033] (2) The thickener in the present invention can be any solvent that can promote the uniform dispersion of sodium hyaluronate and sodium alginate, such as at least one of methylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, hydroxyethyl cellulose, agar or gelatin. As an example, the thickener in the following examples and comparative examples is a mixture of hydroxyethyl cellulose and xanthan gum.

[0034] (3) The carbomer may be at least one of carbomer homopolymer A, carbomer homopolymer B and carbomer homopolymer C. As an example, the carbomer in the following embodiments and comparative examples is carbomer homopolymer B.

[0035] (4) The viscosity of the dressing solution prepared by the present invention is ≥300 mPa·s.

[0036] (5) The molecular weight of sodium hyaluronate used in this application can be 3.0×10 5 ~1.8×10 6 Da, as an example, the molecular weight of sodium hyaluronate in the following examples and comparative examples is 1.0×10 6 ~1.5×10 6 Da.

[0037] (6) The pH adjuster may be a sodium hydroxide solution or a sodium phosphate solution. As an example, the pH adjuster in the following examples and comparative examples is a sodium hydroxide solution.

[0038] Examples 1-3

[0039] The preparation method of the dressing solution is as follows:

[0040] (1) adding carbomer homopolymer B to 95 g of water and soaking it at room temperature for 12 h to obtain solution A;

[0041] (2) adding sodium hyaluronate, sodium alginate, 0.3 g hydroxyethyl cellulose and 0.2 g xanthan gum to a mixture of 5 g glycerol and 2 g propylene glycol while stirring, and continuing stirring for 25 min to obtain solution B;

[0042] (3) Mix solution A and solution B, heat and stir at 85±5°C for 20 min to obtain solution C;

[0043] (4) When the temperature of solution C drops to 50° C., add β-glucan and 1.5 g of tetrahydromethylpyrimidine carboxylic acid, stir for 10 min, and adjust the pH of solution C to 6.5 with sodium hydroxide solution; keep stirring and continue to cool until the temperature of solution C is ≤45° C., discharge the material, and obtain the dressing solution.

[0044] (5) After step (4), the dressing solution is sterilized by wet heat sterilization, the temperature of wet heat sterilization is 121° C., and the sterilization time is 15 min.

[0045] The addition amounts of some materials (carbomer homopolymer B, sodium hyaluronate, sodium alginate and β-glucan) in the above examples are shown in Table 1.

[0046] Table 1. Addition amount of some materials in Examples 1-3

[0047] Experimental groups Example 1 Example 2 Example 3 Carbomer Homopolymer B(g) 0.06 0.06 0.06 Sodium hyaluronate (g) 0.202 0.208 0.204 Sodium alginate(g) 0.08 0.002 0.45 β-Glucan (g) 0.13 0.202 0.003

[0048] Comparative Examples 1-4

[0049] The difference from Example 1 is that the addition amounts of some materials are shown in Table 2.

[0050] Table 2. Addition amount of some materials in Comparative Examples 1-4

[0051] Experimental groups Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Carbomer Homopolymer B(g) - 0.06 0.2 0.06 Sodium hyaluronate (g) 0.202 0.201 0.204 0.202 Sodium alginate(g) 0.092 - 0.068 0.08 β-Glucan (g) 0.178 0.211 - 0.13 Tetrahydromethylpyrimidine carboxylic acid (g) 1.5 1.5 1.5 -

[0052] Comparative Example 5

[0053] The difference from Example 1 is that the amount of sodium alginate was adjusted to 0.6 g.

[0054] Comparative Example 6

[0055] The difference from Example 1 is that the amount of β-glucan was adjusted to 0.7 g.

[0056] Comparative Example 7

[0057] The difference from Example 1 is that β-glucan is replaced by chitosan of the same mass.

[0058] Performance testing

[0059] 1. Security Data

[0060] 1. Multiple (acute) skin irritation test

[0061] The dressing liquid prepared in Examples 1-3 was subjected to multiple (acute) skin irritation tests in accordance with the "Technical Specification for Safety of Cosmetics (2015 Edition)", and specifically, the skin irritation test was conducted using rabbit stimulation. The results show that the rabbit irritation reaction is extremely mild, indicating that the dressing liquid prepared in Examples 1-3 is safe and non-irritating. It can be seen that the dressing liquid is not likely to cause side effects to the human body during use, and can be used with confidence.

[0062] 2. Biocompatibility evaluation

[0063] The biocompatibility of the dressing solutions prepared in Examples 1-3 was evaluated according to GB / T 16886.1-2011 "Biological Evaluation of Medical Devices Part 1: Risk Management Evaluation and Testing". Specifically, the MTT method was used to perform in vitro cytotoxicity testing, and the test results showed that the dressing solutions prepared in Examples 1-3 were non-cytotoxic. For the sake of clarity, only the test results of Example 1 are listed here. The test results of Example 1 are shown in Tables 3 and Figure 1 Among them, the blank control is MEM medium containing 10% fetal bovine serum; the positive control is polyurethane containing zinc diethyldithiocarbamate (ZDEC); the negative control is high-density polyethylene; the sample extract is the sample extracted in different proportions using MEM medium containing 10% fetal bovine serum; the test uses L-929 cells, the cell line comes from the American Type Culture Collection CCL1 (NCTC clone 929). The survival rate in Table 3 is calculated as follows:

[0064] Survival rate (%) = 100 × OD 570e / OD 570b

[0065] Where: OD 570e Indicates the average absorbance of the test sample / negative control / positive control at a wavelength of 570nm; OD 570b It represents the average absorbance of blank control at 570nm wavelength.

[0066] The evaluation criteria for the in vitro cytotoxicity assay in this study are:

[0067] (1) The lower the survival rate, the higher the potential cytotoxicity of the test sample;

[0068] (2) If the viability drops to <70% of the blank, it is potentially cytotoxic;

[0069] (3) The survival rate of the test sample in the 50% extract should be at least the same as or higher than the survival rate in the 100% extract; otherwise, the test should be repeated;

[0070] (4) The survival rate (%) of the 100% test sample extract is the final result.

[0071] It should be noted that for Figure 1 The method of describing cell morphology is shown in Table 4:

[0072] Table 3. In vitro cytotoxicity test results of Example 1

[0073]

[0074] Table 4. Description of cell morphology

[0075]

[0076]

[0077] From the data in Table 3, it can be seen that under the experimental conditions, when 100% of the sample extract was used to treat L-929 cells, the survival rate of L-929 cells was 70.7%, indicating that the dressing extracts prepared in Examples 1-3 of the present invention had no potential toxic effects. This proves that the dressing prepared in the present invention has no cytotoxicity.

[0078] 3. Skin sensitization test

[0079] The skin sensitization test was conducted using the patch method with the dressing solution prepared in Example 1-3, and the test results showed that there was no skin sensitization reaction.

[0080] From the above three performance test tests 1-3, it can be seen that the dressing solution prepared by the present invention has no cytotoxic effect, and will not cause skin irritation or skin sensitization, which means that the product will not release toxic substances that are harmful to health during normal use, has good biocompatibility, and can be used with confidence.

[0081] 2. Microbial stability test

[0082] The microbial contamination level of the dressing solution prepared in Examples 1-3 and Comparative Examples 1-7 was tested by the microbial limit test method. An appropriate amount of the dressing solution prepared in Examples 1-3 and Comparative Examples 1-7 was taken and divided into five equal parts, one of which was sealed and packaged as a control sample and stored at a constant temperature of 20°C; the remaining 4 dressing solutions were sealed and packaged as test samples, numbered as test sample 1, test sample 2, test sample 3 and test sample 4 respectively. Test sample 1 was frozen at 15°C for one month; test sample 2 was frozen at 15°C and then heated to 50°C for thawing, and the cycle lasted for one month; test sample 3 was stored at 50°C for three months; test sample 4 was centrifuged at 2000r / min for 30min.

[0083] Referring to the microbial limit test method in Part 4 of the 2020 edition of the Chinese Pharmacopoeia, the microbial limits of the control sample and the test sample were tested respectively. The experimental data is the average of the results of 3 tests. The experimental results are shown in Table 5.

[0084] Table 5. Microbial limits of each test sample and control sample prepared in Examples 1-3 and Comparative Examples 1-7

[0085]

[0086]

[0087]

[0088]

[0089] The results show that: when the addition amount of carbomer, sodium hyaluronate, sodium alginate, β-glucan and tetrahydromethylpyrimidine carboxylic acid is within the appropriate range defined by the present invention, the samples obtained in Examples 1-3 can meet the sterile level, and can still maintain the qualified microbial level after testing under different environments. It can be explained that the dressing liquid prepared by the present invention has excellent microbial level stability and can meet the use standard. It also further illustrates that the dressing liquid prepared by the preparation method of the present invention has good stability, stable inactivation effect on various types of bacteria, and can achieve long-term preservation without adding preservatives and antibacterial agents. The total colony count, mold and yeast of the test samples of Comparative Examples 1-7 all increase to varying degrees, and Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli are also partially detected, which shows that if any component is missing or the addition amount of each component is not appropriate, it will significantly affect the qualified shelf life of the product.

[0090] 3. Product stability test

[0091] Take appropriate amounts of the patch solutions prepared by wet heat sterilization in Examples 1-3 and Comparative Examples 1-7 as test samples, and take samples before wet heat sterilization in each group as control samples to measure the weight average molecular weight and content of sodium hyaluronate. The weight average molecular weight of sodium hyaluronate was measured by SEC-MALLS method, and the content of sodium hyaluronate was measured by DNS method. The test results are shown in Table 6:

[0092] Table 6. Weight average molecular weight and content of sodium hyaluronate in each test sample and control sample of Examples 1-3 and Comparative Examples 1-7

[0093]

[0094]

[0095] The results show that the samples of Examples 1-3 can maintain the weight average molecular weight and content of sodium hyaluronate without being destroyed under high temperature and wet heat sterilization due to the reasonable ratio of carbomer, sodium hyaluronate, sodium alginate, β-glucan and tetrahydromethylpyrimidine carboxylic acid. If any component is missing or the amount of each component added is not appropriate, the weight average molecular weight and content of sodium hyaluronate in the system will be significantly affected, resulting in poor stability of the dressing solution, thereby reducing the overall performance of the entire dressing solution.

[0096] Combining the data in Tables 5 and 6, it can be seen that there is a positive correlation between the microbial level stability of the dressing solution prepared by the present invention and the molecular stability of the dressing solution. This may be because the various substances in the present invention with appropriate proportions cooperate with each other and synergize to enhance the effectiveness, which can promote the components in the dressing solution to be difficult to decompose while efficiently improving the antibacterial properties of the entire dressing solution, so that the dressing solution can still maintain a qualified microbial level even without adding a sterilizing agent or an antibacterial agent.

[0097] 4. Skin care effect testing experiment

[0098] (1) EASI score

[0099] 88 patients with facial dermatitis admitted to the dermatology department from February 2022 to February 2023 were selected and randomly divided into an observation group and a control group, with 44 people in each group. The control group was given dermatitis drugs every day. In addition to the dermatitis drugs, the observation group used the patch made of the patch solution of Example 1 every evening. The severity index (EASI) was scored for each group member before treatment, for 7 days, and for 14 days. It should be noted that the EASI score is a score for the severity of dermatitis. The scoring method is: the same attending physician evaluates the patient's dermatitis before treatment and 7 days and 14 days after treatment. EASI score = head area score × head severity total score (erythema + infiltration / papule + erosion + lichenification) × 0.1, and each symptom score is 0 to 3 points. The higher the score, the more severe the symptoms. SPSS statistical software was used for data analysis, and the t value indicated that the t test was compared between groups, and p < 0.05 was statistically significant.

[0100] The specific EASI score results are shown in Table 7:

[0101] Table 7. EASI scores

[0102] Group Number of cases Before treatment 7 days of treatment 14 days of treatment Observation Group 44 3.44±1.20 2.10±0.26 1.21±0.45 Control group 44 3.49±1.52 2.79±1.15 2.13±0.87 t-value — 2.539 4.313 3.855 p-value — 0.711 0.038 0.002

[0103] From the data in Table 7, it can be seen that the EASI values ​​of the observation group and the control group after 7 days and 14 days of treatment were lower than those before treatment, and the differences were statistically significant. The EASI values ​​of the observation group at each time period were significantly lower than those of the control group, indicating that the dressing solution prepared by the present invention has a good effect of repairing and maintaining the skin.

[0104] (2) Skin care effect testing

[0105] Through clinical experiments, 62 patients who had undergone micro-plastic surgery admitted to the dermatology department from June 2022 to June 2023 were selected and randomly divided into an observation group and a control group, with 31 people in each group. The control group was given a skin repair dressing containing a preservative, and the observation group was given a dressing made from the dressing solution of Example 1, which was used every night. After 14 days of use, the same attending physician evaluated and counted the therapeutic effects of the two groups of patients. The skin repair dressing containing preservatives here is purchased from a commercially available skin repair dressing, and its main ingredients are as follows: sodium hyaluronate, glycerin, xanthan gum, propylene glycol, phenoxyethanol, purified water and non-woven fabric. The evaluation method is as follows:

[0106] ① Determine the EASI score of each patient in the two groups before and after treatment. EASI score = head area score × total head severity score (erythema + infiltration / papule + erosion + lichenification) × 0.1. Each symptom score ranges from 0 to 3 points.

[0107] ②According to the EASI score, the efficacy index of each patient in the two groups before and after treatment was obtained. The efficacy index = (EASI score before treatment - EASI score after treatment) / EASI score before treatment × 100%;

[0108] ③ Classify and count the treatment effects of patients according to the efficacy index. Specifically, when the efficacy index is ≥90%, the treatment effect is cured; when the efficacy index is ≥50% and <90%, the treatment effect is significant; when the efficacy index is ≥30% and <50%, the treatment effect is effective; when the efficacy index is <30%, the treatment effect is ineffective. After counting, the proportion of various treatment effects of each group of treated patients can be obtained in turn, namely, cure rate, significant rate, effective rate and ineffective rate. The specific results are shown in Table 8. In Table 8, the total effective rate = cure rate + significant rate + effective rate.

[0109] Table 8. Treatment effect records of the two groups

[0110]

[0111]

[0112] According to the data in Table 8, the total effective rate of the observation group after 14 days of use (the effective rate after 14 days of use reached 96.78%) was significantly higher than that of the control group, indicating that the dressing solution without adding preservatives in the present invention has a better repair effect, can prevent wound infection and inflammation, provide a suitable healing environment for the wound, thereby shortening the healing time of the wound, reducing scars and improving the healing quality of the wound. This may be because the skin repair dressing containing preservatives will increase the permeability of harmful substances in the skin, and the preservatives will also cause the skin surface flora imbalance, so the skin care effect of the skin repair dressing containing preservatives is relatively poor.

[0113] In summary, the dressing liquid of the present invention has a good skin care effect because carbomer, sodium hyaluronate, sodium alginate, β-glucan and tetrahydromethylpyrimidine carboxylic acid synergize to form an excellent physical barrier; and without adding preservatives and antibacterial agents, the prepared dressing liquid still has good microbial level stability and can be maintained for a long time, and has excellent efficacy in terms of safety and effectiveness. There is no situation of destroying the molecular weight of the raw materials in the preparation process, which helps each substance to fully play its role and can be used with confidence.

[0114] It should be understood that the disclosed invention is not limited only to the specific method, scheme and material of description, because these all can change.It should also be understood that the terminology used herein is only for the purpose of describing specific embodiment scheme, rather than being intended to limit the scope of the present invention, and the scope of the present invention is only limited to the appended claims.

[0115] Those skilled in the art will also recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are also intended to be encompassed by the appended claims.

Claims

1. A dressing solution, characterized in that: The raw materials of the dressing solution include the following components by weight: 0.06 parts of carbomer, 0.002-0.45 parts of sodium alginate, 0.003-0.202 parts of β-glucan, 1.5 parts of ectoine, 0.202-0.208 parts of sodium hyaluronate, water, moisturizer, pH regulator and thickener; the molecular weight of the sodium hyaluronate is 3.0×10 5 ~1.8×10 6 Da; the dressing solution is sterilized by wet heat sterilization.

2. The dressing liquid according to claim 1, characterized in that: The moisturizer includes glycerin and / or propylene glycol; the thickener includes hydroxyethyl cellulose and / or xanthan gum; the carbomer is selected from at least one of carbomer homopolymer A, carbomer homopolymer B and carbomer homopolymer C; and the pH adjuster is selected from sodium hydroxide or sodium phosphate.

3. The dressing liquid according to claim 2, characterized in that: The viscosity of the dressing liquid is ≥300 mPa·s.

4. The method for preparing the dressing solution according to any one of claims 1 to 3, characterized in that: The steps include: (1) Add carbomer to water and soak for 8 to 24 hours to obtain solution A; (2) Add sodium hyaluronate, sodium alginate and thickener to the moisturizer while stirring, and continue stirring for 20-30 minutes to obtain solution B; (3) Mix solution A and solution B, and heat at 50-90°C for 20-30 min to obtain solution C; (4) When the temperature of solution C drops to 50-65°C, add β-glucan and tetrahydromethylpyrimidine carboxylic acid, stir for 10-25 minutes, and adjust the pH of solution C to 5.0-8.0 with a pH adjuster; keep stirring and continue to cool until the temperature of solution C is ≤45°C, discharge the material, and obtain the dressing solution; (5) After step (4), the dressing solution is sterilized by wet heat sterilization, the temperature of wet heat sterilization is 115-125° C., and the sterilization time is 10-30 minutes.

5. A repair patch, characterized in that: The repair dressing comprises a carrier and the dressing solution according to any one of claims 1 to 3.

6. Use of the dressing solution according to any one of claims 1 to 3 in preparing a product for repairing damaged skin barrier.

7. Use of the dressing solution according to claim 6 in preparing a product for repairing damaged skin barrier, characterized in that: The skin barrier damage is skin barrier damage after medical aesthetics.

Citation Information

Patent Citations

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