Scar repair gel containing recombinant mussel mucin and preparation method thereof

Through scientific proportioning and preparation technology, a scar repair gel with a 'water-in-oil-in-water' system is formed, which solves the problems of poor skin feel and mussel mucin stability of existing products, and achieves anti-inflammatory, antioxidant and comfortable scar repair effects.

CN119679695BActive Publication Date: 2025-10-03SHENZHEN BAIYIN MEDICAL TECHNOLOGY CO LTD
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Patent Information

Application Number
CN202411749455.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-12-02
Publication Date
2025-10-03
Estimated Expiration
2044-12-02

AI Technical Summary

Technical Problem

Existing scar repair gel products have poor skin feel and poor anti-inflammatory and anti-itching effects. In addition, mussel mucin and silicone gel are not compatible and are easily oxidized, affecting stability.

Method used

A scientific ratio of recombinant mussel mucin, silicone, compound emulsifier, thickener, pH regulator and preservative is used to form a 'water-in-oil-in-water' system through heating, stirring and homogenization to ensure the stable compounding of mussel mucin and silicone.

Benefits of technology

It improves the stability and comfort of scar repair gel, enhances its anti-inflammatory and antioxidant effects, reduces itching and scar formation during wound healing, and provides a warm and non-greasy skin feel.

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Abstract

The present invention relates to the technical field of medical dressings, and discloses a scar repair gel containing recombinant mussel mucin and a preparation method thereof. The scar repair gel comprises the following components in percentage by mass: 0.01-0.2% recombinant mussel mucin, 0.4-0.8% thickener, 6-15% compound emulsifier, 1-2% pH adjuster, 20-40% silicone, 0.1-0.3% preservative and the balance of water, wherein the silicone comprises polydimethylsiloxane, polydimethylsiloxane crosslinker and decamethylcyclopentasiloxane. The scar repair gel containing recombinant mussel mucin has good film-forming properties, forms a moisturizing barrier on the surface of the wound, can inhibit the formation of hypertrophic scars, reduce itching during wound healing, reduce the production and deposition of melanin, effectively improve the patient's comfort during use and the stability of the mussel mucin and silicone gel system.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical dressings, in particular to a scar repair gel containing recombinant mussel mucin and a preparation method thereof. Background Art

[0002] Scars form when the human skin is severely damaged by physical or chemical factors, leaving the body unable to fully repair itself. Scars are instead formed by the deposition of collagen secreted by proliferating fibroblasts. Scars not only affect appearance but also weaken skin function, causing both physical and mental distress to patients. As people prioritize health and appearance, market demand for scar repair materials continues to grow.

[0003] Since Perkins et al. discovered that silicone can inhibit scar formation, a wave of silicone-based scar repair products has emerged on the market. Silicone gels have become the preferred scar treatment due to their effectiveness, ease of use, and affordability. However, currently available silicone scar repair gels often have a greasy feel, lack comfort, and may be associated with itching and rashes.

[0004] Mussel mucin is rich in dopa groups and possesses excellent anti-inflammatory and antioxidant properties. Adding mussel mucin to silicone scar repair gels can enhance the anti-itching effect of scar gels and improve pigmentation and other issues. However, mussel mucin dissolves in water and is poorly formulated directly with silicone gel oil phases, prone to delamination and aggregation, which can also compromise the mussel protein's anti-inflammatory and anti-itching effects. Therefore, ensuring the compatibility of recombinant mussel mucin with silicone gels and ensuring the protein's stable efficacy is crucial.

[0005] Therefore, the existing technology still needs to be improved and developed. Summary of the Invention

[0006] In view of the above-mentioned deficiencies in the prior art, the object of the present invention is to provide a scar repair gel containing recombinant mussel mucin and a preparation method thereof, aiming to solve the problems that the existing scar repair gel products themselves have poor skin feel, poor anti-inflammatory and antipruritic effects, and are easily oxidized and have poor compatibility after directly adding mussel mucin.

[0007] The technical solutions of the present invention are as follows:

[0008] The first aspect of the present invention provides a scar repair gel containing recombinant mussel mucin, comprising the following components in percentage by mass: 0.01-0.2% recombinant mussel mucin, 0.4-0.8% thickener, 6-15% compound emulsifier, 1-2% pH adjuster, 20-40% silicone, 0.1-0.3% preservative and the balance water; the silicone comprises polydimethylsiloxane, polydimethylsiloxane crosslinker and decamethylcyclopentasiloxane.

[0009] Optionally, in the silicone, the mass ratio of polydimethylsiloxane, polydimethylsiloxane crosslinker and decamethylcyclopentasiloxane is (1-3): (3-5): (3-5).

[0010] Optionally, the compound emulsifier includes an oil phase emulsifier and an aqueous phase emulsifier, the oil phase emulsifier is one or more of sorbitan oleate 80, glyceryl mono- and distearate, fumed silica and polyethylene glycol-polydimethylsiloxane copolymer, and the aqueous phase emulsifier is one or more of polysorbate 80, cetostearyl alcohol, glyceryl stearate and PEG-100-stearate.

[0011] Optionally, the mass ratio of the aqueous phase emulsifier to the oil phase emulsifier is (5-8):(1-3).

[0012] Optionally, the thickener is one or more of carbomer, methylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol and dextran.

[0013] Optionally, the pH adjuster is one or more of sodium hydroxide, sodium acetate, diethanolamine, triethanolamine, lactic acid, malic acid, fumaric acid, sodium carbonate, sodium bicarbonate and sodium hydrogen phosphate.

[0014] Optionally, the preservative is one or more of methylparaben, ethylparaben, propylparaben, sodium paraben, sodium propylparaben, sodium benzoate, phenoxyethanol, sorbic acid, potassium sorbate, benzyl alcohol, hexylene glycol, pentylene glycol, ethylhexylglycerin and parahydroxyacetophenone.

[0015] The second aspect of the present invention provides a method for preparing the scar repair gel containing recombinant mussel mucin, comprising the steps of:

[0016] (a) weighing silicone and a compound emulsifier, adding the compound emulsifier to the silicone, heating and stirring, and homogenizing to obtain a solution A;

[0017] (b) Weighing a thickener, adding it to water, heating and stirring, and then homogenizing to obtain solution B;

[0018] (c) slowly adding the solution B to the solution A multiple times under homogenizing conditions, and cooling to room temperature to obtain solution C;

[0019] (d) Weighing the lyophilized powder of recombinant mussel mucin, adding it to water and stirring to form a solution, adding the recombinant mussel mucin solution to the solution C while stirring, and then adding the weighed preservative and pH adjuster to obtain the scar repair gel containing recombinant mussel mucin.

[0020] In step (a), optionally, the heating and stirring temperature is 75-85° C., the heating and stirring time is 1-3 h, and the stirring speed is 300-500 rpm.

[0021] In step (b), optionally, the heating and stirring temperature is 75-85° C., the heating and stirring time is 1-1.5 h, and the stirring speed is 300-500 rpm.

[0022] Beneficial effects:

[0023] (1) The scar repair gel containing recombinant mussel mucin provided by the present invention is rich in dopa and has good film-forming, anti-inflammatory, antioxidant, and wet adhesion capabilities, which helps to alleviate the redness, swelling, and itching during the wound healing process. The scar repair gel containing recombinant mussel mucin has good film-forming properties, forms a moisturizing barrier on the surface of the wound, can inhibit the formation of hypertrophic scars, reduce itching during the wound healing process, reduce the production and deposition of melanin, and effectively improve the comfort of patients during use.

[0024] (2) The scar repair gel containing recombinant mussel mucin provided by the present invention solves the problem of poor compatibility between silicone components and recombinant mussel mucin by adjusting the scientific ratio of oil phase emulsifier and water phase emulsifier, thereby enhancing the stability of the scar repair gel; it also improves the stability of the recombinant mussel mucin contained therein, and can be placed stably for a long time, while having a warm and non-greasy skin feel. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 These are macroscopic photographs of the scar repair gel containing recombinant mussel mucin prepared in Example 1 of the present invention before heating, after heating for 10 minutes, and after standing for 60 minutes.

[0026] Figure 2 These are macroscopic photos of a water droplet spread on a glass slide before heating, after heating for 10 minutes, and after standing for 60 minutes.

[0027] Figure 3 This is a schematic diagram of the process for preparing the scar repair gel containing recombinant mussel mucin according to Example 1 of the present invention.

[0028] Figure 4 This is a macroscopic picture of the scar repair gel containing recombinant mussel mucin prepared in Comparative Example 2 after centrifugation after being placed in a 45°C environment for 7 days.

[0029] Figure 5 This is a macroscopic picture of the scar repair gel containing recombinant mussel mucin prepared in Comparative Example 3 after centrifugation after being placed in a 45°C environment for 60 days.

[0030] Figure 6These are the clinical efficacy test results of the scar repair gel containing recombinant mussel mucin prepared in Example 1 of the present invention on scars on the elbow wounds of subjects.

[0031] Figure 7 These are the clinical efficacy test results of the scar repair gel containing recombinant mussel mucin prepared in Example 1 of the present invention on scars on the wound surface of the subjects' arms.

[0032] Figure 8 These are the clinical efficacy test results of the scar repair gel containing recombinant mussel mucin prepared in Example 1 of the present invention on leg wound scars of subjects. DETAILED DESCRIPTION

[0033] The present invention provides a scar repair gel containing recombinant mussel mucin and a preparation method thereof. To clarify the objectives, technical solutions, and effects of the present invention, the present invention is described in further detail below. It should be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention.

[0034] Unless otherwise defined, all technical terms and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0035] An embodiment of the present invention provides a scar repair gel containing recombinant mussel mucin, comprising the following components in percentage by mass: 0.01-0.2% recombinant mussel mucin, 0.4-0.8% thickener, 6-15% compound emulsifier, 1-2% pH adjuster, 20-40% silicone, 0.1-0.3% preservative and the balance water; the silicone comprises polydimethylsiloxane, polydimethylsiloxane crosslinker and decamethylcyclopentasiloxane.

[0036] The recombinant mussel mucin has a high content of DOPA and has good film-forming properties, anti-inflammatory and antioxidant properties, and wet adhesion capabilities, which helps to alleviate the redness, swelling, and itching problems during the wound healing process. The compound emulsifier enhances the stability of the scar repair gel and the stability of the recombinant mussel mucin, and can be placed stably for a long time, while having a warm and non-greasy skin feel. The silicone is cross-linked with components such as the thickener and recombinant mussel mucin to form a layer of silicone-protein mixed membrane structure, which can enhance the moisture retention of the wound and help inhibit the formation of hypertrophic scars. Therefore, the scar repair gel containing recombinant mussel mucin of the present invention has good film-forming properties, can be applied to the surface of a healed wound to form a moisturizing barrier, can inhibit the formation of hypertrophic scars, reduce itching during the wound healing process, and effectively improve the patient's comfort during use, solving the problems of poor skin feel and itching relief of existing silicone-containing scar repair products and poor stability of the compound of mussel mucin and silicone gel.

[0037] In some embodiments, in the silicone, the mass ratio of polydimethylsiloxane, polydimethylsiloxane cross-linked product and decamethylcyclopentasiloxane is (1-3):(3-5):(3-5).

[0038] Silicone is a mixture of polydimethylsiloxane, polydimethylsiloxane cross-linked products, and decamethylcyclopentasiloxane. Polydimethylsiloxane and polydimethylsiloxane cross-linked products have excellent biocompatibility and hydrophobicity, and are the main components that form the moisturizing oil film in scar repair gels. Decamethylcyclopentasiloxane has good lubricity and volatility, and is an important component in scar repair gels that promotes the formation of moisturizing oil films. Decamethylcyclopentasiloxane has excellent lubricity and volatility, which can improve the skin feel of the product. Through volatilization, it promotes the rapid (physical) cross-linking of polydimethylsiloxane and polydimethylsiloxane cross-linked products with thickeners, recombinant mussel mucin, and other substances in the product to form a silicone-protein hybrid membrane structure. This structure can enhance wound moisturizing, help inhibit the formation of hypertrophic scars, alleviate redness, swelling, and itching during wound healing, and lighten the color of scars.

[0039] In some embodiments, the compound emulsifier includes an oil phase emulsifier and an aqueous phase emulsifier, the oil phase emulsifier is one or more of sorbitan oleate 80, glyceryl mono- and distearate, fumed silica, and polyethylene glycol-polydimethylsiloxane copolymer, and the aqueous phase emulsifier is one or more of polysorbate 80, cetostearyl alcohol, glyceryl stearate, and PEG-100-stearate.

[0040] In some embodiments, the mass ratio of the aqueous phase emulsifier to the oil phase emulsifier is (5-8):(1-3).

[0041] The present invention adopts a compound emulsifier to better fuse the aqueous phase and the oil phase, and combines the "water-in-oil-in-water" system formed in the preparation process of the scar repair gel to complete the mixing of the recombinant mussel mucin in the aqueous phase and the oil phase, thereby improving the greasy skin feel and solving the problem of poor compatibility between the silicone system itself and the recombinant mussel mucin. The scar repair gel is enhanced in stability and can be stored stably for a long time, thereby improving the stability of the effective component recombinant mussel mucin in the gel, so that it can exert its efficacy stably for a long time, solving the problems of poor skin feel and poor itching relief of existing silicone-containing scar repair products, and also making the scar repair gel have a warm and non-greasy skin feel.

[0042] In some embodiments, the thickening agent is one or more of carbomer, methylcellulose, hydroxyethylcellulose, hypromellose, polyvinyl alcohol, and dextran.

[0043] Thickeners can form a certain physical cross-linking structure, which has a certain protective effect on the recombinant mussel mucin in the scar repair gel that is easily oxidized; at the same time, physical cross-linking can increase the viscosity of the scar repair gel and improve the skin feel; and to a certain extent, it can act as an emulsifier to enhance the stability of the oil phase / water phase system, thereby extending the storage time of the scar repair gel.

[0044] In some embodiments, the pH adjuster is one or more of sodium hydroxide, sodium acetate, diethanolamine, triethanolamine, lactic acid, malic acid, fumaric acid, sodium carbonate, sodium bicarbonate, and sodium hydrogen phosphate.

[0045] In some embodiments, the preservative is one or more of methylparaben, ethylparaben, propylparaben, sodium paraben, sodium propylparaben, sodium benzoate, phenoxyethanol, sorbic acid, potassium sorbate, benzyl alcohol, hexylene glycol, pentylene glycol, ethylhexylglycerin and parahydroxyacetophenone.

[0046] The second aspect of the present invention provides a method for preparing the scar repair gel containing recombinant mussel mucin, comprising the steps of:

[0047] (a) weighing silicone and a compound emulsifier, adding the compound emulsifier to the silicone, heating and stirring, and homogenizing to obtain a solution A;

[0048] In step (a), in some embodiments, the heating and stirring temperature is 75-85° C., the heating and stirring time is 1-3 h, and the stirring speed is 300-500 rpm.

[0049] (b) Weighing a thickener, adding it to water, heating and stirring, and then homogenizing to obtain solution B;

[0050] In step (b), in some embodiments, the heating and stirring temperature is 75-85° C., the heating and stirring time is 1-1.5 h, and the stirring speed is 300-500 rpm.

[0051] In some specific embodiments, the water is one of purified water, distilled water, deionized water, and water for injection, but is not limited thereto.

[0052] (c) slowly adding the solution B to the solution A multiple times under homogenizing conditions, and cooling to room temperature to obtain a solution C;

[0053] In the step (c), solution A is an oil phase solution, and solution B is an aqueous phase solution. The aqueous phase solution is slowly added to the oil phase solution, and the oil phase wraps the aqueous phase to form an oil-in-water system. After further adding more aqueous phase solution, the entire system is transformed into a water-in-oil-in-water system. The stability of the resulting solution is greatly increased, and the stable storage time is greatly extended.

[0054] (d) Weighing the lyophilized powder of recombinant mussel mucin, adding it to water and stirring to form a solution, adding the recombinant mussel mucin solution to the solution C while stirring, and then adding the weighed preservative and pH adjuster to obtain the scar repair gel containing recombinant mussel mucin.

[0055] The present invention combines the "water-in-oil-in-water" system formed during the preparation process to enhance the stability of the gel product and the stability of the recombinant mussel mucin, allowing for long-term stable storage. At the same time, the scar repair gel product feels moist and non-greasy on the skin and has good film-forming properties. It can be applied to the surface of a healed wound to form a moisturizing barrier, thereby helping to inhibit the formation of hypertrophic scars.

[0056] The following describes it in detail through specific examples.

[0057] Example 1

[0058] Oil phase solution: 35.0% silicone, 6% Tween 80, 1.0% Span 80; the silicone is a mixture of polydimethylsiloxane (20%), polydimethylsiloxane crosslinker (40%), and decamethylcyclopentasiloxane (40%), with a viscosity of 1.2w;

[0059] Aqueous phase solution: 0.6% carbomer and 45.0% pure water; pH adjuster is 1.5% triethanolamine; preservatives are 0.1% sodium methylparaben and 0.1% sodium propylparaben.

[0060] The preparation steps of the recombinant mussel mucin scar repair gel as above:

[0061] S1. Accurately take 35.0% of the prescribed amount of silicone and add it to a beaker;

[0062] S2. Accurately weigh the prescribed amount of emulsifier and add it to the S1 solution. Heat it to 80±5°C, stir evenly, and keep heating for 1 hour or more.

[0063] S3. Accurately weigh the prescribed amount of carbomer, add it to pure water, heat it to 80±5°C, and keep heating for 1.5 hours or more;

[0064] S4. Accurately weigh the prescribed amount of recombinant mussel mucin freeze-dried powder, add it to pure water, and stir evenly;

[0065] S5. Use a homogenizer to fully homogenize the solution obtained in step S3;

[0066] S6. Use a homogenizer to fully homogenize the solution obtained in step S2 to obtain a milky white solution. Slowly add the solution obtained in step S5 to the milky white solution several times at 9 krpm, and cool to room temperature.

[0067] S7, accurately taking the prescribed amount of the solution obtained in step S4 and adding it to the solution in step S6 under stirring at 350 rpm;

[0068] S8. Accurately weigh the prescribed amount of preservatives and triethanolamine, add them to the solution obtained in S7 while stirring at 350 rpm, pour into the aluminum-plastic tube and seal it.

[0069] Film forming performance test

[0070] According to the test method of Shandong Provincial Food and Drug Evaluation and Inspection Center - Product Film Formation Research Test Data, take 1 sample and 2 clean slides, take pure water drops on the slides at room temperature, and spread the water drops evenly. Place the above sample in a 37℃ oven and heat for 10 minutes. After heating, take it out and observe the appearance of the smeared area. The results are shown in the figure. Figure 1 and Figure 2 .

[0071] like Figure 1 As shown in a, b and c in the figure, after the scar repair gel containing recombinant mussel mucin prepared in the example was heated in an oven at 37°C for 10 minutes, a light white oily protective layer was observed on the product. When the glass slide was turned back and forth, no liquid flow was observed. After the glass slide containing the scar repair gel was placed on a workbench for 60 minutes, the scar repair gel product was completely dry and a transparent oily protective layer was observed on the glass slide.

[0072] like Figure 2 As shown in a, b and c, after heating in a 37°C oven for 10 minutes, the water droplets on the pure water slide have not dried, and no protective layer is visible. When the slide is turned back and forth, the water droplets flow; after placing the slide containing pure water on the workbench for 60 minutes, the water droplets have not dried, and no protective layer is visible.

[0073] The above results show that thanks to the scar repair gel formula and preparation process, the scar repair gel product containing recombinant mussel mucin has good adhesion and film-forming properties.

[0074] Figure 3 The process flow diagram for preparing the above-mentioned process is as follows, wherein, by slowly adding the aqueous phase solution to the oil phase solution multiple times under homogenizing conditions, under the condition of compounding an emulsifier, an "oil-in-water" system and a "water-in-oil-in-water" system are sequentially formed. This enhances the stability of the product and the stability of the recombinant mussel mucin, allowing for long-term stable storage, making the scar repair gel product feel moist and non-greasy on the skin.

[0075] The formulas for preparing scar repair gels in Examples 1 to 5 are shown in Table 1 below:

[0076] Table 1

[0077]

[0078]

[0079] Protein / DOPA content test

[0080] According to the fourth part of the 2020 edition of the Chinese Pharmacopoeia (General Rule 0731 Protein Content Determination Method II Folin-phenol Method 2) and YY / T 1293.6-2020 Contact Wound Dressing Part 6: Mussel Mucin Dressing, Examples 1 to 5 were tested for protein content and DOPA content, respectively. The protein content and DOPA content in the scar repair gel prepared in Examples 1 to 5 are shown in Table 2 below:

[0081] Table 2

[0082]

[0083] The scar repair gel in Example 1 has a warm feel on the skin, is stable without delamination after aging at 45° C. for 60 days, and has little change in skin feel.

[0084] The silicone viscosity in Example 2 was lower than that in Example 1, resulting in a similar skin feel for the scar repair gel. Silicones of varying viscosities can lead to differences in the skin feel and stability of the final product. Experimental results show that silicone with a viscosity of 1.2w provides the best overall skin feel and stability. Silicone with a viscosity of 5000w is prone to oil-water separation, silicone with a viscosity of 1.8w feels slightly greasy, and silicone with a viscosity of 2.5w is difficult to formulate into a uniform gel.

[0085] The DOPA content of the scar repair gel in Example 3 was significantly reduced, indicating that the protective effect of cellulose on recombinant mussel mucin or DOPA was not as good as that of carbomer.

[0086] In Example 4, the replacement of the preservative had little effect on the state of the scar repair gel.

[0087] In Example 5, an oil-in-water system was formed, and the scar repair gel had a slightly greasy feel on the skin. Oil-water separation occurred after 7 days at 45°C, indicating that the scar repair gel prepared with an oil-phase emulsifier-based formula had poor stability and was prone to oil-water separation.

[0088] In Comparative Examples 1-5, the mass percentages of the components in the formula of Example 1 were adjusted. In Comparative Example 6, the recombinant mussel mucin was replaced with collagen. Scar repair gels were obtained using the same preparation methods as in Example 1.

[0089] The formulas used in Comparative Examples 1-6 are shown in Table 3 below:

[0090] Table 3

[0091]

[0092] Gel stability test

[0093] According to the standards of GB 30612-2014 National Food Safety Standard Food Additive Polydimethylsiloxane and Emulsion thereof and GB / T 29665-2013 Skin Care Emulsion, Comparative Examples 1 to 5 were subjected to a centrifugal test at 3000 rpm for 30 minutes. Table 4 shows the centrifugal stability test results of Comparative Examples 1 to 5:

[0094] Table 4

[0095]

[0096]

[0097] In Comparative Example 1, too much silicone (50%) was used, and the water phase could not completely encapsulate the oil phase during the mixing process of the oil phase and the water phase. The resulting product showed oil-water stratification after centrifugation. After being placed in a 45°C environment, significant oil-water stratification was observed after centrifugation after 3 days, indicating that the use of more silicone in this comparative example would lead to poor stability of the scar repair gel.

[0098] In Comparative Example 2, too much oil phase emulsifier (≥6%) was used, and the resulting product was a water-in-oil system. The overall color was milky white and the skin felt greasy. After being placed in a 45°C environment for 7 days, significant oil-water separation occurred. Figure 4 The scar repair gel prepared in this comparative example has poor skin feel and poor stability.

[0099] In Comparative Example 3, a larger amount of aqueous emulsifier (≥8%) was used, and the resulting product was an oil-in-water system with an overall off-white color. The product felt moist and non-greasy on the skin. It did not delaminate after being placed in a 45°C environment for 60 days, but turned yellow during accelerated aging. The emulsion system has good stability and a comfortable skin feel, but if Figure 5 As shown, protein dopa is easily oxidized (turns yellow), and the scar gel's effectiveness in relieving itching and lightening scars becomes ineffective.

[0100] In Comparative Example 4, a relatively large amount of thickener (≥0.8%) was used. During the preparation process, the viscosity was too high, and the obtained product had a high viscosity and was uneven, and oil-water separation was easily caused.

[0101] In Comparative Example 5, a relatively large amount of recombinant mussel mucin (≥0.2%) was added. Since the recombinant mussel mucin carries a positive charge, a high content of recombinant mussel mucin easily attracts the negatively charged thickener, resulting in agglomeration.

[0102] In Comparative Example 6, after the recombinant mussel mucin was replaced with collagen, the anti-itching effect of the scar repair gel product was weakened.

[0103] Biocompatibility testing

[0104] In order to verify the biosafety of the scar repair gel sample, according to the "GB / T 16886 Biological Evaluation of Medical Devices" series of standards, the sample in Example 1 with the best stability and skin feel was selected for efficacy and related biocompatibility testing.

[0105] The biocompatibility test of the scar repair gel is shown in Table 5 below:

[0106] Table 5

[0107]

[0108] Efficacy testing: human efficacy evaluation

[0109] According to the Patient and Observer Scar Assessment Scale (POSAS), the clinical efficacy of the scar on the elbow wound, arm wound and leg wound of the subjects was tested. The scar was applied twice a day, morning and evening. The corresponding results of Example 1 are as follows: Figure 6-8 The results showed that the recombinant mussel mucin scar repair gel has a good effect in inhibiting scar formation.

[0110] Based on the patient scale of the Patient and Observer Scar Assessment Scale (POSAS), Example 1 with the best stability, Example 3 in which the thickener was replaced, and Comparative Example 7 in which the recombinant mussel mucin was replaced with recombinant collagen were selected for confirmation of the antipruritic effect. The antipruritic effect on the wound scars of 10 subjects is shown in Table 6:

[0111] Table 6:

[0112] sample efficient Effectiveness (%) Example 1 9 90% Example 3 7 70% Comparative Example 7 6 60%

[0113] Results: The addition of recombinant mussel mucin can effectively improve the itching symptoms during wound healing, and its antipruritic effect is better than that of the recombinant collagen group. The content of recombinant mussel mucin decreases after oxidation, and its antipruritic effect is reduced.

[0114] It should be understood that the application of the present invention is not limited to the above examples. For those skilled in the art, improvements or changes can be made based on the above description. All these improvements and changes should fall within the scope of protection of the claims attached to the present invention.

Claims

1. A scar repair gel containing recombinant mussel mucin, characterized in that: The invention comprises the following components in percentage by mass: 0.01-0.2% recombinant mussel mucin, 0.4-0.8% thickener, 6-15% compound emulsifier, 1-2% pH adjuster, 20-40% silicone, 0.1-0.3% preservative and the balance water; the silicone comprises polydimethylsiloxane, polydimethylsiloxane crosslinked product and decamethylcyclopentasiloxane; The compound emulsifier includes an oil phase emulsifier and an aqueous phase emulsifier, wherein the oil phase emulsifier is one or more of sorbitan oleate 80, glyceryl mono- and distearate, fumed silica, and polyethylene glycol-polydimethylsiloxane copolymer, and the aqueous phase emulsifier is one or more of polysorbate 80, cetostearyl alcohol, glyceryl stearate, and PEG-100 stearate; The mass ratio of the aqueous phase emulsifier to the oil phase emulsifier is (5-8): (1-3); In the silicone, the mass ratio of polydimethylsiloxane, polydimethylsiloxane crosslinked product and decamethylcyclopentasiloxane is (1-3): (3-5): (3-5); The thickener is one or more of carbomer, methylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol and dextran.

2. The scar repair gel containing recombinant mussel mucin according to claim 1, characterized in that: The pH regulator is one or more of sodium hydroxide, sodium acetate, diethanolamine, triethanolamine, lactic acid, malic acid, fumaric acid, sodium carbonate, sodium bicarbonate and sodium hydrogen phosphate.

3. The scar repair gel containing recombinant mussel mucin according to claim 1, characterized in that: The preservative is one or more of methylparaben, ethylparaben, propylparaben, sodium methylparaben, sodium propylparaben, sodium benzoate, phenoxyethanol, sorbic acid, potassium sorbate, benzyl alcohol, hexylene glycol, pentylene glycol, ethylhexylglycerin and p-hydroxyacetophenone.

4. A method for preparing a scar repair gel containing recombinant mussel mucin according to any one of claims 1 to 3, characterized in that: Including steps: (a) Weighing silicone and a compound emulsifier, adding the compound emulsifier to the silicone, heating and stirring, and homogenizing to obtain a solution A; (b) Weighing a thickener, adding it to water, heating and stirring, and then homogenizing to obtain solution B; (c) slowly adding the solution B to the solution A multiple times under homogenizing conditions, and cooling to room temperature to obtain solution C; (d) Weighing the lyophilized powder of recombinant mussel mucin, adding it to water and stirring to form a solution, adding the recombinant mussel mucin solution to the solution C while stirring, and then adding the weighed preservative and pH adjuster to obtain the scar repair gel containing recombinant mussel mucin.

5. The method for preparing the scar repair gel containing recombinant mussel mucin according to claim 4, characterized in that: In step (a), the heating and stirring temperature is 75-85° C., the heating and stirring time is 1-3 h, and the stirring speed is 300-500 rpm.

6. The method for preparing the scar repair gel containing recombinant mussel mucin according to claim 4, characterized in that: In step (b), the heating and stirring temperature is 75-85° C., the heating and stirring time is 1-1.5 h, and the stirring speed is 300-500 rpm.

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