Medical dressing for skin repair and production process thereof

Abstract

The invention relates to the technical field of medical instruments, and discloses a medical dressing for skin repair and a production process thereof, the medical dressing is prepared by taking sodium alginate and carboxymethyl cellulose as base materials and taking a macromolecular antibacterial agent, medical grade sodium hyaluronate and the like as auxiliary materials through the processes of mixing, standing for gelling and freeze drying. Wherein the macromolecular antibacterial agent is a shikimic acid derived macromolecular substance connected by a quaternary ammonium cation group, and a large number of active hydroxyl functional groups can be generated in the preparation process of the macromolecular antibacterial agent and can generate a hydrogen bond association network with sodium alginate, carboxymethyl cellulose and the like in the dressing, so that pores of the formed medical dressing are more compact, and the antibacterial property of the medical dressing is improved. Meanwhile, the macromolecular antibacterial agent can endow the dressing with excellent broad-spectrum antibacterial performance, and the macromolecular antibacterial agent cannot be easily migrated in the hydrogen bond association network, so that the antibacterial effect of the dressing can be guaranteed.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a medical dressing for skin repair and a production process thereof. BACKGROUND

[0002] Skin, as the largest organ of the human body, bears core functions such as protection, metabolism, immunity and perception. However, damage types such as burns, trauma, surgical incisions and chronic ulcers not only destroy the skin barrier function, but also may cause infection, inflammatory response and scar formation, therefore, it is necessary to use a dressing and other external medical devices to assist in recovery, help wound healing. Although traditional gauze, cotton pad and other dressings can physically cover the wound, they have defects such as easy adhesion, liquid retention, poor antibacterial properties, resulting in pain during dressing change, increased risk of infection and prolonged healing period. Therefore, it is a clinical necessity to develop a new type of medical dressing that has antibacterial, healing and scar reduction properties.

[0003] Gel dressing, as a new type of functional medical material, has shown significant advantages in the field of skin repair due to its unique physical and chemical properties and biocompatibility. In the process of wound repair, wound infection is the primary risk factor for delayed healing, which requires the dressing to have excellent antibacterial properties. However, conventional gel dressings generally need to add cationic quaternary ammonium salt or natural antibacterial agents to achieve antibacterial modification of the dressing. However, in practical applications, it is found that most small molecule quaternary ammonium salts have the phenomenon of easy precipitation and migration, and have the problem of poor antibacterial durability. In addition, natural antibacterial agents are easily oxidized, which also makes it difficult to ensure the long-term antibacterial properties of the dressing. Based on this, the present application provides a medical dressing with good antibacterial effect for skin repair, solving the problems in the prior art. SUMMARY

[0004] In order to solve the problems mentioned in the background art, the purpose of the present application is to provide a medical dressing for skin repair and a production process thereof.

[0005] The purpose of the present application can be achieved by the following technical solutions: A medical dressing for skin repair, comprising the following raw materials in parts by weight: Sodium alginate 25-35 parts; Carboxymethyl cellulose 10-15 parts; Macromolecular antibacterial agent 1-3 parts; Medical grade sodium hyaluronate 3-6 parts; Biomass glue 5-10 parts; Deionized water 40-50 parts.

[0006] As a further scheme of the present application, the preparation method of the macromolecular antibacterial agent comprises the following steps: Step one, the shikimic acid is added to the ethanol solution with volume fraction of 60-70%, after stirring and mixing uniformly, the condensing agent and catalyst are added to the formed mixture, after adding, stirring at room temperature for 30-60 min, then the functional modification reagent is added, after adding, the temperature is increased to 40-50℃, after stirring and keeping warm for 6-12 h, the heating is stopped, the temperature is decreased to take out the product, and the shikimic acid derivative is prepared; Step two, the shikimic acid derivative and methanol are added to the reaction kettle filled with nitrogen, after adding, the stirring is started, after stirring uniformly, the chain elongating agent is added to the reaction kettle, after adding, the mixture is stirred and mixed uniformly, the heating is started, the temperature is increased to 70-80℃, and the temperature is kept for 12-18 h, then the heating is stopped, and the product is separated after natural cooling, and the macromolecular antibacterial agent is prepared after purification and treatment.

[0007] As a further scheme of the present application, in step one, the condensing agent is dicyclohexyl carbodiimide or 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide.

[0008] As a further scheme of the present application, in step one, the catalyst is any one of N-hydroxysuccinimide, 4-dimethylaminopyridine or 1-hydroxybenzotriazole.

[0009] As a further scheme of the present application, in step one, the molar ratio of the shikimic acid and the functional modification reagent is 1:1.

[0010] As a further scheme of the present application, in step one, the functional modification reagent is 1,3-diglycidyl ether glycerol or 3-[bis(glycidyloxymethyl)methoxy]-1,2-propanediol.

[0011] As a further scheme of the present application, in step two, the chain elongating agent is pentamethyl diethylene triamine or 1,1,4,7,10,10-hexamethyl triethylene tetramine.

[0012] As a further scheme of the present application, in step two, the molar ratio of the shikimic acid derivative and the chain elongating agent is 1:0.8-1.

[0013] In the above technical scheme, first, the condensing agent and the catalyst are used to activate the substituted carboxyl of the shikimic acid, then the hydroxyl substituent in the structure of the functional modification reagent is condensed, so that the shikimic acid derivative containing multiple active epoxy substituents in the structure is prepared, the epoxy substituent in the structure can continuously quaternary ammonium reaction with the tertiary amine in the structure of the chain elongating agent under high temperature conditions, so that the macromolecular substance derived from the shikimic acid connected by the quaternary ammonium cation group, i.e. the macromolecular antibacterial agent, is prepared.

[0014] As a further scheme of the present application, the biomass glue is any one of gelatin, xanthan gum or pectin.

[0015] A production process of a medical dressing for skin repair, comprising the following steps: The first step is to weigh each raw material according to the weight fraction, and complete the preparation; The second step is to add sodium alginate, carboxymethyl cellulose, a macromolecular antibacterial agent, medical-grade sodium hyaluronate and biomass glue into deionized water, mechanically stir and mix uniformly, then pour into a mold, stand for gelation, and then place in a freeze dryer for freeze drying, thereby obtaining the medical dressing.

[0016] The beneficial effects of the present application are: The present application uses a shikimic acid derivative macromolecule connected by a quaternary ammonium cation group as a macromolecular antibacterial agent. Firstly, a large number of active hydroxyl functional groups are generated in the quaternization ring-opening reaction process, which can form a hydrogen bond association network with sodium alginate, carboxymethyl cellulose and medical-grade sodium hyaluronate in the dressing, thereby producing a bridging effect to connect each raw material into a whole. Therefore, the mixture of each raw material has excellent gelation properties. After freeze drying, the formed aerogel-type medical dressing has a more compact pore structure, thereby exhibiting excellent water absorption and moisture absorption effects, which can maintain the dryness of the wound surface and keep the wound surface in a relatively dry environment, which is conducive to accelerating the wound healing process. Secondly, the macromolecular antibacterial agent structure contains a large number of quaternary ammonium cations and natural antibacterial agent shikimic acid structures, which can synergize to give the dressing excellent broad-spectrum antibacterial properties. In the hydrogen bond association network, the macromolecular antibacterial agent is "confined" and cannot easily migrate, thereby ensuring the antibacterial persistence of the dressing.

[0017] Of course, implementing any product of the present application does not necessarily require achieving all the advantages described above. DETAILED DESCRIPTION

[0018] The technical solutions of the present application will be described below in conjunction with the embodiments, obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0019] Embodiment 1 A medical dressing for skin repair, comprising the following raw materials according to weight fraction: Sodium alginate 25 parts; Carboxymethyl cellulose 10 parts; Macromolecular antibacterial agent 1 part; Medical-grade sodium hyaluronate 3 parts; Gelatin 5 parts; Deionized water 40 parts.

[0020] The preparation method of the medical dressing comprises the following steps: Step 1, each raw material is weighed according to the weight fraction, and the preparation is completed; Step 2, sodium alginate, carboxymethyl cellulose, macromolecular antibacterial agent, medical grade sodium hyaluronate and gelatin are added to deionized water, mechanically stirred and mixed uniformly, then poured into a mold, and placed in a freeze dryer for freeze drying, thereby obtaining the medical dressing.

[0021] The preparation method of the macromolecular antibacterial agent comprises the following steps: Step 1, 0.5g shikimic acid is added to an ethanol solution with a volume fraction of 60%, stirred and mixed uniformly, then 1,3-diepoxy glycerol glycerol is added to the formed mixture, after the addition is completed, the temperature is increased to 45℃, and the stirring is continued for 9h, then the heating is stopped, the temperature is lowered, and the product is separated out, and after the purification process, the macromolecular antibacterial agent is obtained. Step 2, 0.3g shikimic acid derivative and methanol are added to a nitrogen-filled reaction kettle, then the stirring is started, 0.12g pentamethyl diethylene triamine is added to the reaction kettle after the stirring is uniform, then the mixture is mixed uniformly, the heating is started, the temperature is increased to 75℃, and the temperature is maintained for 16h, then the heating is stopped, the product is separated out after natural cooling, and after the purification process, the macromolecular antibacterial agent is obtained.

[0022] Example 2 A medical dressing for skin repair, according to the weight fraction, comprises the following raw materials: Sodium alginate 26 parts; Carboxymethyl cellulose 12 parts; Macromolecular antibacterial agent 1.5 parts; Medical grade sodium hyaluronate 4 parts; Xanthan gum 6 parts; Deionized water 45 parts.

[0023] The preparation method of the medical dressing comprises the following steps: Step 1, each raw material is weighed according to the weight fraction, and the preparation is completed; Step 2, sodium alginate, carboxymethyl cellulose, macromolecular antibacterial agent, medical grade sodium hyaluronate and xanthan gum are added to deionized water, mechanically stirred and mixed uniformly, then poured into a mold, and placed in a freeze dryer for freeze drying, thereby obtaining the medical dressing.

[0024] The preparation method of the macromolecular antibacterial agent is the same as that in Example 1.

[0025] Example 3 A medical dressing for skin repair, comprising, by weight, the following ingredients: 28 parts of sodium alginate; 12 parts carboxymethyl cellulose; Two parts of macromolecular antibacterial agent; Four parts of medical-grade sodium hyaluronate; 8 parts xanthan gum; 45 parts of deionized water.

[0026] The preparation method of the medical dressing includes the following steps: Step 1: Weigh each raw material according to the specified weight proportions to complete the material preparation; The second step involves adding sodium alginate, carboxymethyl cellulose, macromolecular antibacterial agent, medical-grade sodium hyaluronate, and xanthan gum to deionized water, mechanically stirring until evenly mixed, pouring the mixture into a mold, allowing it to stand to form a gel, and then placing it in a freeze dryer for freeze drying to obtain the medical dressing.

[0027] The preparation method of the macromolecular antibacterial agent is the same as that in Example 1.

[0028] Example 4 A medical dressing for skin repair, comprising, by weight, the following ingredients: 30 parts sodium alginate; 12 parts carboxymethyl cellulose; 2.5 parts of macromolecular antibacterial agent; Four parts of medical-grade sodium hyaluronate; 8 parts xanthan gum; 45 parts of deionized water.

[0029] The preparation method of the medical dressing includes the following steps: Step 1: Weigh each raw material according to the specified weight proportions to complete the material preparation; The second step involves adding sodium alginate, carboxymethyl cellulose, macromolecular antibacterial agent, medical-grade sodium hyaluronate, and xanthan gum to deionized water, mechanically stirring until evenly mixed, pouring the mixture into a mold, allowing it to stand to form a gel, and then placing it in a freeze dryer for freeze drying to obtain the medical dressing.

[0030] The preparation method of the macromolecular antibacterial agent is the same as that in Example 1.

[0031] Example 5 A medical dressing for skin repair, comprising, by weight, the following ingredients: 35 parts sodium alginate; 15 parts carboxymethyl cellulose; 3 parts of macromolecular antibacterial agent; Six parts of medical-grade sodium hyaluronate; 10 parts xanthan gum; 50 parts deionized water.

[0032] The preparation method of the medical dressing includes the following steps: Step 1: Weigh each raw material according to the specified weight proportions to complete the material preparation; The second step involves adding sodium alginate, carboxymethyl cellulose, macromolecular antibacterial agent, medical-grade sodium hyaluronate, and xanthan gum to deionized water, mechanically stirring until evenly mixed, pouring the mixture into a mold, allowing it to stand to form a gel, and then placing it in a freeze dryer for freeze drying to obtain the medical dressing.

[0033] The preparation method of the macromolecular antibacterial agent is the same as that in Example 1.

[0034] Comparative Example 1 A medical dressing for skin repair, comprising, by weight, the following ingredients: 28 parts of sodium alginate; 12 parts carboxymethyl cellulose; 2.5 parts of shikimic acid; Four parts of medical-grade sodium hyaluronate; 8 parts xanthan gum; 45 parts of deionized water.

[0035] The preparation method of the medical dressing includes the following steps: Step 1: Weigh each raw material according to the specified weight proportions to complete the material preparation; The second step involves adding sodium alginate, carboxymethyl cellulose, shikimic acid, medical-grade sodium hyaluronate, and xanthan gum to deionized water, mechanically stirring until evenly mixed, pouring the mixture into a mold, allowing it to stand to form a gel, and then placing it in a freeze dryer for freeze drying to obtain the medical dressing.

[0036] Comparative Example 2 A medical dressing for skin repair, comprising, by weight, the following ingredients: 28 parts of sodium alginate; 12 parts carboxymethyl cellulose; Four parts of medical-grade sodium hyaluronate; 8 parts xanthan gum; 45 parts of deionized water.

[0037] The preparation method of the medical dressing includes the following steps: Step 1: Weigh each raw material according to the specified weight proportions to complete the material preparation; The second step involves adding sodium alginate, carboxymethyl cellulose, medical-grade sodium hyaluronate, and xanthan gum to deionized water, mechanically stirring until evenly mixed, pouring the mixture into a mold, allowing it to stand to form a gel, and then placing it in a freeze dryer for freeze drying to obtain the medical dressing.

[0038] Test case ① Prepare test samples with a diameter of 5 mm using the medical dressings from the examples and comparative examples, leave them for one month, and then coat the surface of the nutrient agar medium with a concentration of 10. 5 CFU / mL Staphylococcus aureus bacterial suspension was prepared, and then the test sample was placed on nutrient agar medium and incubated at 37°C for 12 hours before the diameter of the inhibition zone was measured. ② Take a mass of medical dressing M from the examples and comparative examples, then soak it in water. After it becomes saturated with water, take it out and drain it until no more water drips. Record the mass as m. Calculate the water absorption ratio of the medical dressing using the formula (mM) / M.

[0039] Analysis of the test results shows that the medical dressing made with the addition of macromolecular antibacterial agents has significantly better antibacterial properties and better water absorption, which can absorb a large amount of exudate from the wound, thus promoting wound healing.

[0040] Replacing macromolecular antibacterial agents with natural antibacterial agents such as shikimic acid has several drawbacks. Firstly, shikimic acid is unstable and oxidizes during storage, leading to its inactivation. Secondly, the absence of quaternary ammonium salt cationic antibacterial components results in a significant decrease in the antibacterial properties of the prepared dressing. Furthermore, since shikimic acid cannot act as a "bridge" to connect the various components, the resulting aerogel structure has low porosity, affecting the water absorption and moisture absorption of the medical dressing.

[0041] This document uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of these embodiments are merely to aid in understanding the method and core ideas of the present invention, including the best mode, and to enable any person skilled in the art to practice the present invention, including manufacturing and using any device or system, and implementing any combined method. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from its principles, and these improvements and modifications also fall within the scope of protection of the claims. The scope of protection of this patent is defined by the claims and may include other embodiments that can be conceived by those skilled in the art. If these other embodiments have structural elements similar to those expressed in the claims, or if they include equivalent structural elements that are not substantially different from those expressed in the claims, then these other embodiments should also be included within the scope of the claims.

[0042] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A medical dressing for skin repair, characterized in that, By weight, it includes the following ingredients: 25-35 parts sodium alginate; 10-15 parts of carboxymethyl cellulose; 1-3 parts of macromolecular antibacterial agent; 3-6 parts of medical-grade sodium hyaluronate; 5-10 parts of biomass gum; 40-50 parts deionized water.

2. The medical dressing for skin repair according to claim 1, characterized in that, The preparation method of the macromolecular antibacterial agent includes the following steps: Step 1: Add shikimic acid to a 60-70% (v / v) ethanol solution, stir and mix thoroughly. Then add a condensing agent and a catalyst to the mixture. After the addition is complete, stir at room temperature for 30-60 minutes. Then add a functionalizing agent. After the addition is complete, raise the temperature to 40-50℃, keep it warm and stir for 6-12 hours. Then stop heating, cool down and discharge the material to obtain the shikimic acid derivative. Step 2: Add shikimic acid derivative and methanol to a nitrogen-filled reactor. After the addition is complete, start stirring until the mixture is homogeneous. Then add the chain elongating agent to the reactor. After the addition is complete, mix the mixture thoroughly. Start heating and raise the temperature to 70-80℃. Maintain the temperature for 12-18 hours. Stop heating and allow the mixture to cool naturally. Separate the product and purify it to obtain the macromolecular antibacterial agent.

3. A medical dressing for skin repair according to claim 2, characterized in that, In step one, the condensing agent is dicyclohexylcarbodiimide or 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide.

4. A medical dressing for skin repair according to claim 2, characterized in that, In step one, the catalyst is any one of N-hydroxysuccinimide, 4-dimethylaminopyridine, or 1-hydroxybenzotriazole.

5. A medical dressing for skin repair according to claim 2, characterized in that, In step one, the molar ratio of shikimic acid to the functionalizing agent is 1:

1.

6. A medical dressing for skin repair according to claim 2, characterized in that, In step one, the functionalizing agent is 1,3-diepoxyglycerol ether glycerol or 3-[bis(glycidoxymethyl)methoxy]-1,2-propanediol].

7. A medical dressing for skin repair according to claim 2, characterized in that, In step two, the chain elongating agent is pentamethyldiethylenetriamine or 1,1,4,7,10,10-hexamethyltriethylenetetramine.

8. A medical dressing for skin repair according to claim 2, characterized in that, In step two, the molar ratio of the shikimic acid derivative and the chain elongating agent is 1:0.8-1.

9. A medical dressing for skin repair according to claim 1, characterized in that, The biomass gum is any one of gelatin, xanthan gum, or pectin.

10. A manufacturing process for a medical dressing for skin repair as described in claim 1, characterized in that, Includes the following steps: Step 1: Weigh each raw material according to the specified weight proportions to complete the material preparation; The second step involves adding sodium alginate, carboxymethyl cellulose, macromolecular antibacterial agent, medical-grade sodium hyaluronate, and biomass gel to deionized water, mechanically stirring until evenly mixed, pouring the mixture into a mold, allowing it to stand to form a gel, and then placing it in a freeze dryer for freeze drying to obtain the medical dressing.

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