Scar repair gel containing recombinant mussel mucin and preparation method thereof

Abstract

The 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 is prepared from the following components in percentage by mass: 0.01 to 0.2 percent of recombinant mussel mucin, 0.4 to 0.8 percent of a thickening agent, 6 to 15 percent of a compound emulsifier, 1 to 2 percent of a pH regulator, 20 to 40 percent of silicone, 0.1 to 0.3 percent of a preservative and the balance of water, wherein the silicone comprises polydimethylsiloxane, a polydimethylsiloxane cross-linking agent and decamethylcyclopentasiloxane. The scar repair gel containing the recombinant mussel mucin has good film-forming property, forms a moisturizing barrier on the surface of a wound, can inhibit formation of hyperplasia scars, reduces pruritus in the wound healing process, reduces generation and deposition of melanin, and has the effects of repairing scars and repairing scars. The comfort of a patient in the use process and the compounding stability of the mussel mucin and silicone gel system are effectively improved.

Description

Technical Field

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

[0002] Scars are formed when the human skin tissue is severely damaged by physical, chemical and other factors, and the body cannot completely repair it. Scars are formed by the deposition of collagen secreted by the proliferating fibroblasts. Scars not only affect the appearance, but also weaken the skin function, causing physical and mental pain to the patient. As people pay more attention to health and appearance, the market demand for scar repair materials continues to grow.

[0003] Since Perkins and others discovered that silicone can inhibit scar formation, a series of scar repair products based on silicone have emerged on the market. Silicone gel has become the first choice for scar treatment due to its significant effects, simple use, and low price. Currently, the silicone scar repair gels on the market usually feel greasy on the skin, are not comfortable to use, and may be accompanied by itching, rashes and other problems when used.

[0004] Mussel mucin contains abundant dopa groups and has excellent anti-inflammatory and antioxidant effects. If mussel mucin is added to silicone scar repair gel, it can enhance the anti-itching effect of scar gel products and improve pigmentation and other problems. However, mussel mucin is dissolved in the water phase and is not well compounded with the silicone gel oil phase system. It is prone to stratification or agglomeration problems, and may also affect the anti-inflammatory and anti-itching effects of mussel protein. Therefore, the compatibility of recombinant mussel mucin with silicone gel and the problem of ensuring the stability of the protein's efficacy need to be solved.

[0005] Therefore, the prior art 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 solution of the present invention is 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 crosslinked product and decamethylcyclopentasiloxane is (1-3): (3-5): (3-5).

[0010] Optionally, the compound emulsifier includes an oil phase emulsifier and a water 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 water phase emulsifier is one or more of polysorbate 80, cetearyl alcohol, glyceryl stearate and PEG-100-stearate.

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

[0012] Optionally, the thickener is one or more of carbomer, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, 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 a solution B;

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

[0019] (d) Weighing the lyophilized powder of recombinant mussel mucin, adding it into water and stirring to form a solution, adding the recombinant mussel mucin solution into the solution C under 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) In the scar repair gel containing recombinant mussel mucin provided by the present invention, the recombinant mussel mucin is rich in DOPA, has good film-forming, anti-inflammatory and antioxidant, and wet adhesion capabilities, and helps to relieve redness, swelling and itching during wound healing. 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 hyperplastic scars, reduce itching during wound healing, reduce the generation 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 being placed for 60 minutes.

[0026] Figure 2 These are macroscopic photographs 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 test 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 the scar on the wound surface of the subject's arm.

[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 scars on the legs of subjects. DETAILED DESCRIPTION

[0033] The present invention provides a scar repair gel containing recombinant mussel mucin and a preparation method thereof. To make the purpose, technical scheme and effect of the present invention clearer and more specific, the present invention is further described in detail below. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used 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] The 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% of recombinant mussel mucin, 0.4-0.8% of thickener, 6-15% of compound emulsifier, 1-2% of pH adjuster, 20-40% of silicone, 0.1-0.3% of preservative and the balance of water; the silicone comprises polydimethylsiloxane, polydimethylsiloxane crosslinked product and decamethylcyclopentasiloxane.

[0036] The recombinant mussel mucin has a high content of DOPA, good film-forming properties, anti-inflammatory and antioxidant properties, and wet adhesion capabilities, which helps to alleviate the redness, swelling, and itching problems during wound healing. The compound emulsifier enhances the stability of the scar repair gel and the stability of the recombinant mussel mucin, which can be placed stably for a long time and have a warm and non-greasy skin feel. The silicone is cross-linked with components such as a 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 wound healing, and effectively improve the patient's comfort during use, solving the problems of poor skin feel and poor itching relief of existing silicone-containing scar repair products and poor stability 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. Among them, polydimethylsiloxane and polydimethylsiloxane cross-linked products have excellent biocompatibility and hydrophobicity, and are the main components of the moisturizing oil film formed in scar repair gel; decamethylcyclopentasiloxane has good lubricity and volatility, and is an important component in scar repair gel that promotes the formation of moisturizing oil film. Decamethylcyclopentasiloxane has excellent lubricity and volatility, which can improve the skin feel of the product, and through volatility, promote polydimethylsiloxane and polydimethylsiloxane cross-linked products to quickly cross-link with thickeners, recombinant mussel mucin and other substances in the product (physical) to form a layer of silicone-protein mixed membrane structure, which can enhance the moisturizing of the wound surface, help inhibit the formation of hypertrophic scars, relieve the redness, swelling and itching problems during wound healing, and lighten the color of scars.

[0039] In some embodiments, the compound emulsifier includes an oil phase emulsifier and a water 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 water phase emulsifier is one or more of polysorbate 80, cetearyl alcohol, glyceryl stearate and PEG-100-stearate.

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

[0041] The present invention adopts a composite emulsifier to better fuse the water phase and the oil phase, combines with the "water-in-oil-in-water" system formed in the preparation process of the scar repair gel, completes the mixing of the recombinant mussel mucin of the water phase and the oil phase, improves the greasy skin feel, solves the problem of poor compatibility between the silicone system itself and the recombinant mussel mucin, enhances the stability of the scar repair gel, and can be placed 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, solves the problem that the existing silicone-containing scar repair products have poor skin feel and poor itching, and also makes 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, hydroxypropylmethylcellulose, 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 and prolong 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 p-hydroxyacetophenone.

[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 a 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 homogenization 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 system is transformed into a water-in-oil-in-water system as a whole, and the stability of the obtained solution is greatly increased, and the stable storage time is greatly extended.

[0054] (d) Weighing the lyophilized powder of recombinant mussel mucin, adding it into water and stirring to form a solution, adding the recombinant mussel mucin solution into the solution C under 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, and can be stored stably for a long time. At the same time, the scar repair gel product feels warm and non-greasy on the skin, has good film-forming properties, and is applied to the surface of the healed wound to form a moisturizing barrier, which is beneficial to inhibiting the formation of hypertrophic scars.

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

[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 crosslinked (40%) and decamethylcyclopentasiloxane (40%), with a silicone 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 into a beaker;

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

[0063] S3. Accurately weigh the prescribed amount of carbomer, add it to pure water, heat it to 80±5℃, and keep heating for 1.5h 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 multiple 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, drop pure water on the slides at room temperature, and spread the water droplets 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 position. The results are shown in Figure 1 and Figure 2 .

[0071] like Figure 1 As shown in a, b and c, after the scar repair gel containing recombinant mussel mucin prepared in the example was heated in an oven at 37°C for 10 minutes, it was observed that the product formed a light white oily protective layer, and no liquid flow was observed when the glass slide was turned back and forth; 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 an oven at 37°C for 10 minutes, the water droplets on the pure water slide did not dry up, and no protective layer was visible. When the slide was turned back and forth, the water droplets flowed. After placing the slide containing pure water on the workbench for 60 minutes, the water droplets did not dry up, and no protective layer was 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 diagram for preparing the above-mentioned process is that, 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 formed in sequence, thereby enhancing the stability of the product and the stability of the recombinant mussel mucin, allowing it to be stably placed for a long time, so that the scar repair gel product feels warm 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 Part IV of the 2020 edition of the Chinese Pharmacopoeia (General Rule 0731 Protein Content Determination Method Second Method Folin-phenol Method 2) and YY / T 1293.6-2020 Contact Wound Dressings Part 6: Mussel Mucin Dressings, 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 moist skin feel, is centrifugal stable without stratification after aging at 45° C. for 60 days, and has little change in skin feel.

[0084] The viscosity of silicone in Example 2 is lower than that in Example 1, and the skin feel of the scar repair gel is similar. Silicones with different viscosities will lead to different skin feel and stability of the final product. The experimental results show that the product prepared by silicone with a viscosity of 1.2w has the best comprehensive skin feel and stability, the product with a viscosity of 5000 is easy to separate into oil and water, the product with a viscosity of 1.8w feels slightly greasy, and the product with a viscosity of 2.5w is difficult to prepare to form a uniform gel product.

[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 change of preservatives has 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 felt slightly greasy. Oil-water separation occurred at 45° C. for 7 days, indicating that the scar repair gel prepared with an oil-phase emulsifier as the main formulation had poor stability and was prone to oil-water separation.

[0088] In Comparative Examples 1-5, the mass percentage of each component in the formula of Example 1 was adjusted, and in Comparative Example 6, the recombinant mussel mucin was replaced with collagen. The scar repair gel was obtained by the same preparation method 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 Emulsions thereof" and "GB / T 29665-2013 Skin Care Emulsions", Comparative Examples 1 to 5 were subjected to a centrifugal test at 3000 rpm for 30 min. 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 envelop the oil phase during the mixing process of the oil phase and the water phase. The obtained product showed oil-water stratification after centrifugation. When placed in an environment of 45°C, 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 an oil-in-water system, which was milky white as a whole and greasy on the skin. After being placed in a 45°C environment for 7 days, oil-water separation was obvious, such as 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. It was placed in a 45°C environment for 60 days without stratification, and the color 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 anti-itching and scar-lightening effects become 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 prone to occur.

[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 the recombinant mussel mucin easily attracts the negatively charged thickener and causes agglomeration.

[0102] In Comparative Example 6, after the recombinant mussel mucin was replaced with collagen, the antipruritic 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 observer scale in 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] According to the patient scale in 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 to confirm the antipruritic effect. The antipruritic effects of wound scars on 10 subjects are 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 decreases.

[0114] It should be understood that the application of the present invention is not limited to the above examples. For ordinary technicians in this field, 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% of recombinant mussel mucin, 0.4-0.8% of thickener, 6-15% of compound emulsifier, 1-2% of pH regulator, 20-40% of silicone, 0.1-0.3% of preservative and the balance of water; the silicone comprises polydimethylsiloxane, polydimethylsiloxane crosslinking material and decamethylcyclopentasiloxane.

2. The scar repair gel containing recombinant mussel mucin according to claim 1, characterized in that: In the silicone, the mass ratio of polydimethylsiloxane, polydimethylsiloxane crosslinked product and decamethylcyclopentasiloxane is (1-3): (3-5): (3-5).

3. The scar repair gel containing recombinant mussel mucin according to claim 1, characterized in that: The compound emulsifier comprises an oil phase emulsifier and a water 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 water phase emulsifier is one or more of polysorbate 80, cetostearyl alcohol, glyceryl stearate and PEG-100-stearate.

4. The scar repair gel containing recombinant mussel mucin according to claim 3, characterized in that: The mass ratio of the water phase emulsifier to the oil phase emulsifier is (5-8):(1-3).

5. The scar repair gel containing recombinant mussel mucin according to claim 1, characterized in that: The thickener is one or more of carbomer, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, polyvinyl alcohol and dextran.

6. 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.

7. 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 paraben, sodium propylparaben, sodium benzoate, phenoxyethanol, sorbic acid, potassium sorbate, benzyl alcohol, hexylene glycol, pentylene glycol, ethylhexylglycerin and p-hydroxyacetophenone.

8. A method for preparing a scar repair gel containing recombinant mussel mucin according to any one of claims 1 to 7, characterized in that: Includes 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 a solution B; (c) slowly adding the solution B to the solution A multiple times under homogenization conditions, and cooling to room temperature to obtain a solution C; (d) Weighing the lyophilized powder of recombinant mussel mucin, adding it into water and stirring to form a solution, adding the recombinant mussel mucin solution into the solution C under stirring, and then adding the weighed preservative and pH adjuster to obtain the scar repair gel containing recombinant mussel mucin.

9. The method for preparing the scar repair gel containing recombinant mussel mucin according to claim 8, 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.

10. The method for preparing the scar repair gel containing recombinant mussel mucin according to claim 8, 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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