A medical sodium hyaluronate dressing and preparation method thereof

Abstract

The invention relates to the technical field of medical dressings, and discloses a medical sodium hyaluronate dressing and a preparation method thereof, comprising a substrate and a dressing coated on the substrate, wherein the dressing is composed of the following raw materials in parts by weight: 2 to 5 parts of sodium hyaluronate, 2 to 5 parts of carbomer, 1 to 3 parts of antibacterial agent, 1 to 3 parts of analgesic and anti-inflammatory agent, 15 to 20 parts of glycerol, 8 to 12 parts of bioactive glass powder, 5 to 8 parts of propylene glycol, and the remainder is purified water. The bioactive glass powder is 45S5 bioactive glass, and 80% of the powder particle size is 1.0 to 5.0 μm. The antibacterial agent is selected from tea tree oil, cinnamon oil and honey, and the analgesic and anti-inflammatory agent is selected from aloe extract, allantoin and licorice extract. The present invention significantly improves the moisture retention, antibacterial and anti-inflammatory effects of the dressing by optimizing the components and the preparation method, reduces the use of antibiotics and silver ions, has good biosafety, no cytotoxicity, no skin irritation, and is suitable for the treatment of various wounds.

Description

Technical Field

[0001] The invention relates to the technical field of medical dressings, and in particular to a medical sodium hyaluronate dressing and a preparation method thereof. Background Art

[0002] With the development of medical technology, medical dressings play an important role in promoting wound healing, preventing infection and relieving pain. Traditional medical dressings are mostly made of single materials, such as gauze and non-woven fabrics. Although they can provide basic protection and absorption functions, they have limitations in terms of moisture retention, antibacterial properties and biocompatibility. In recent years, sodium hyaluronate has been widely used in medical dressings due to its excellent moisture retention and biocompatibility, but high molecular weight sodium hyaluronate has poor permeability and is difficult to fully play its role in promoting wound healing. In addition, the antibiotics and antibacterial components such as silver ions commonly used in traditional dressings have drug resistance and potential cytotoxicity problems, which limit their wide application in clinical practice. Therefore, the development of a medical sodium hyaluronate dressing with excellent moisture retention, high-efficiency antibacterial and anti-inflammatory effects, good biocompatibility and mechanical properties has become the focus of current research. Therefore, we propose a medical sodium hyaluronate dressing and a preparation method thereof. Summary of the invention

[0003] The main purpose of the present invention is to provide a medical sodium hyaluronate dressing and a preparation method thereof, which can effectively solve the problems in the background technology.

[0004] To achieve the above object, the technical solution adopted by the present invention is:

[0005] A medical sodium hyaluronate dressing comprises a substrate and a dressing coated on the substrate, wherein the dressing is composed of the following raw materials in parts by weight: 2-5 parts of sodium hyaluronate, 2-5 parts of carbomer, 1-3 parts of antibacterial agent, 1-3 parts of analgesic and anti-inflammatory agent, 15-20 parts of glycerol, 8-12 parts of bioactive glass powder, 5-8 parts of propylene glycol, and the balance is purified water.

[0006] Preferably, the sodium hyaluronate is low molecular weight sodium hyaluronate, and its molecular weight is 250-350 kDa.

[0007] Preferably, the bioactive glass powder is 45S5 bioactive glass, and 80% of the bioactive glass powder has a particle size of 1.0 to 5.0 μm.

[0008] Preferably, the antibacterial agent is one or a combination of tea tree oil, cinnamon oil and honey.

[0009] Preferably, the analgesic and anti-inflammatory agent is selected from aloe extract, allantoin and licorice extract, and the mass ratio of the aloe extract, allantoin and licorice extract is 3:1:2.

[0010] Preferably, the substrate is a hydrogel.

[0011] The present invention also discloses a method for preparing a medical sodium hyaluronate dressing, comprising the following steps:

[0012] S1: Add sodium hyaluronate to deionized water at 50°C and stir for 15 to 30 minutes until it is completely dissolved to form a sodium hyaluronate solution;

[0013] S2: Slowly add carbomer into the sodium hyaluronate solution while stirring at high speed to ensure that the carbomer is evenly dispersed;

[0014] S3: slowly add the antibacterial agent and the analgesic and anti-inflammatory agent to the solution of S2 in sequence, stirring while adding, and after stirring evenly, slowly add glycerin and propylene glycol to the solution, stirring while adding, until the mixture is evenly mixed;

[0015] S4: slowly adding the bioactive glass powder into the mixed solution of S3, stirring at high speed, and then using an ultrasonic disperser to evenly disperse the bioactive glass powder in the mixed solution of S3;

[0016] S5: Continue stirring the solution of S4 at a stirring speed of 500 rpm for 30 min until the solution is completely uniform and a stable mixed solution is formed;

[0017] S6: The prepared mixed solution is evenly coated on the hydrogel substrate, and sterilized after drying to obtain a medical sodium hyaluronate dressing.

[0018] Preferably, in S2 and S4, the rotation speed of the high-speed stirring is 1000 rpm, and the stirring time is 10 to 15 min; in S3, the entire stirring process adopts low-speed stirring, and the rotation speed is 200 to 300 rpm.

[0019] Preferably, in S4, the power of the ultrasonic disperser is 200 W, the frequency is 20 kHz, and the processing time is 12 to 15 minutes.

[0020] Preferably, in S6, the coating method may be any one of spraying, dipping and brushing, and the coating thickness is 0.8-1.2 mm.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. The present invention significantly improves the moisturizing performance of the dressing by using low molecular weight sodium hyaluronate (250-350 kDa). Low molecular weight sodium hyaluronate has stronger moisturizing ability and permeability, can quickly absorb and lock moisture, maintain a moist environment for the wound, promote cell proliferation and migration, and accelerate wound healing. In addition, sodium hyaluronate has good biocompatibility, almost no immunogenicity and toxicity, and is suitable for various types of wounds.

[0023] 2. The present invention The present invention uses a variety of natural antibacterial agents such as tea tree oil, cinnamon oil and honey, as well as analgesic and anti-inflammatory agents such as aloe extract, allantoin and licorice extract. These natural ingredients have a broad spectrum of antibacterial and anti-inflammatory effects, can effectively inhibit the growth and reproduction of bacteria, reduce the risk of infection, and reduce inflammatory reactions and relieve pain. Through the use of these natural ingredients, the present invention significantly reduces the use of antibiotics and silver ions, reduces the drug resistance and side effects that may be caused by excessive use of antibiotics and silver ions, and has good biosafety.

[0024] 3. The present invention significantly improves the mechanical properties and biological activity of the dressing by adding 45S5 bioactive glass powder. The particle size of the bioactive glass powder is controlled at 1.0 to 5.0 μm, and can be evenly dispersed in the dressing, improving the mechanical strength and toughness of the dressing, making it more durable. At the same time, the bioactive glass powder can release ions (such as calcium, silicon, phosphorus, etc.), promote the formation of extracellular matrix and cell proliferation, and accelerate wound healing. In addition, the bioactive glass powder also has certain antibacterial and anti-inflammatory effects, further enhancing the comprehensive performance of the dressing.

[0025] 4. The present invention selects hydrogel as the substrate. The hydrogel has good air permeability and softness, can fit the irregular wound surface, and reduce friction and discomfort. At the same time, the high water absorption and water retention of the hydrogel can keep the wound moist and promote healing. In addition, the preparation method of the present invention is simple and easy. By accurately controlling the temperature, stirring speed and time of each step, the uniform dispersion and stable mixing of the components are ensured, and the final dressing has good skin compatibility and ease of use. All ingredients have undergone strict biosafety tests to ensure that they are non-cytotoxic, non-skin irritating, and will not cause damage to the human body, and are suitable for various clinical application scenarios. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 The present invention is a preparation flow chart of a medical sodium hyaluronate dressing. DETAILED DESCRIPTION

[0027] Example 1

[0028] like Figure 1As shown, a medical sodium hyaluronate dressing includes a substrate and a dressing coated on the substrate, wherein the dressing is composed of the following raw materials in parts by weight: 2 parts of sodium hyaluronate, 2 parts of carbomer, 1 part of antibacterial agent, 1 part of analgesic and anti-inflammatory agent, 15 parts of glycerin, 8 parts of bioactive glass powder, 5 parts of propylene glycol, and the balance is purified water.

[0029] Wherein, the sodium hyaluronate is low molecular weight sodium hyaluronate, and its molecular weight is 250-350 kDa.

[0030] Wherein, the bioactive glass powder is 45S5 bioactive glass, and 80% of the bioactive glass powder has a particle size of 1.0 to 5.0 μm.

[0031] Wherein, the antibacterial agent is one or a combination of tea tree oil, cinnamon oil and honey.

[0032] Wherein, the analgesic and anti-inflammatory agent is selected from aloe extract, allantoin and licorice extract, and the mass ratio of the aloe extract, allantoin and licorice extract is 3:1:2.

[0033] Wherein, the substrate is a hydrogel.

[0034] The preparation method of the medical dressing containing collagen comprises the following steps:

[0035] S1: Add sodium hyaluronate to deionized water at 50°C and stir for 15 to 30 minutes until it is completely dissolved to form a sodium hyaluronate solution;

[0036] S2: Slowly add carbomer to the sodium hyaluronate solution while stirring at high speed. The speed of high-speed stirring is 1000 rpm and the stirring time is 10 to 15 minutes to ensure that the carbomer is evenly dispersed.

[0037] S3: slowly add the antibacterial agent and the analgesic and anti-inflammatory agent to the solution of S2 in sequence, stirring at a low speed of 200-300 rpm, and after stirring evenly, slowly add glycerin and propylene glycol to the solution, stirring at a low speed of 200-300 rpm, until the mixture is evenly mixed;

[0038] S4: slowly add the bioactive glass powder to the mixed solution of S3, stirring at high speed, the speed of high-speed stirring is 1000 rpm, the stirring time is 10 to 15 minutes, and then use an ultrasonic disperser to evenly disperse the bioactive glass powder in the mixed solution of S3, the power of the ultrasonic disperser is 200 W, the frequency is 20 kHz, and the processing time is 12 to 15 minutes;

[0039] S5: Continue stirring the solution of S4 at a stirring speed of 500 rpm for 30 min until the solution is completely uniform and a stable mixed solution is formed;

[0040] S6: The prepared mixed solution is evenly coated on the hydrogel substrate. The coating method can be any one of spraying, dipping and brushing. The coating thickness is 0.8 to 1.2 mm. After drying, sterilization is performed to obtain a medical sodium hyaluronate dressing.

[0041] Example 2

[0042] like Figure 1 As shown, a medical sodium hyaluronate dressing includes a substrate and a dressing coated on the substrate, wherein the dressing is composed of the following raw materials in parts by weight: 5 parts of sodium hyaluronate, 5 parts of carbomer, 3 parts of antibacterial agent, 3 parts of analgesic and anti-inflammatory agent, 20 parts of glycerol, 12 parts of bioactive glass powder, 8 parts of propylene glycol, and the balance is purified water.

[0043] Wherein, the sodium hyaluronate is low molecular weight sodium hyaluronate, and its molecular weight is 250-350 kDa.

[0044] Wherein, the bioactive glass powder is 45S5 bioactive glass, and 80% of the bioactive glass powder has a particle size of 1.0 to 5.0 μm.

[0045] Wherein, the antibacterial agent is one or a combination of tea tree oil, cinnamon oil and honey.

[0046] Wherein, the analgesic and anti-inflammatory agent is selected from aloe extract, allantoin and licorice extract, and the mass ratio of the aloe extract, allantoin and licorice extract is 3:1:2.

[0047] Wherein, the substrate is a hydrogel.

[0048] The preparation method of the medical dressing containing collagen comprises the following steps:

[0049] S1: Add sodium hyaluronate to deionized water at 50°C and stir for 15 to 30 minutes until it is completely dissolved to form a sodium hyaluronate solution;

[0050] S2: Slowly add carbomer to the sodium hyaluronate solution while stirring at high speed. The speed of high-speed stirring is 1000 rpm and the stirring time is 10 to 15 minutes to ensure that the carbomer is evenly dispersed.

[0051] S3: slowly add the antibacterial agent and the analgesic and anti-inflammatory agent to the solution of S2 in sequence, stirring at a low speed of 200-300 rpm, and after stirring evenly, slowly add glycerin and propylene glycol to the solution, stirring at a low speed of 200-300 rpm, until the mixture is evenly mixed;

[0052] S4: slowly add the bioactive glass powder to the mixed solution of S3, stirring at high speed, the speed of high-speed stirring is 1000 rpm, the stirring time is 10 to 15 minutes, and then use an ultrasonic disperser to evenly disperse the bioactive glass powder in the mixed solution of S3, the power of the ultrasonic disperser is 200 W, the frequency is 20 kHz, and the processing time is 12 to 15 minutes;

[0053] S5: Continue stirring the solution of S4 at a stirring speed of 500 rpm for 30 min until the solution is completely uniform and a stable mixed solution is formed;

[0054] S6: The prepared mixed solution is evenly coated on the hydrogel substrate. The coating method can be any one of spraying, dipping and brushing. The coating thickness is 0.8 to 1.2 mm. After drying, sterilization is performed to obtain a medical sodium hyaluronate dressing.

[0055] Example 3

[0056] like Figure 1 As shown, a medical sodium hyaluronate dressing includes a substrate and a dressing coated on the substrate, wherein the dressing is composed of the following raw materials in parts by weight: 4 parts of sodium hyaluronate, 3 parts of carbomer, 2 parts of antibacterial agent, 2 parts of analgesic and anti-inflammatory agent, 18 parts of glycerol, 10 parts of bioactive glass powder, 6 parts of propylene glycol, and the balance is purified water.

[0057] Wherein, the sodium hyaluronate is low molecular weight sodium hyaluronate, and its molecular weight is 250-350 kDa.

[0058] Wherein, the bioactive glass powder is 45S5 bioactive glass, and 80% of the bioactive glass powder has a particle size of 1.0 to 5.0 μm.

[0059] Wherein, the antibacterial agent is one or a combination of tea tree oil, cinnamon oil and honey.

[0060] Wherein, the analgesic and anti-inflammatory agent is selected from aloe extract, allantoin and licorice extract, and the mass ratio of the aloe extract, allantoin and licorice extract is 3:1:2.

[0061] Wherein, the substrate is a hydrogel.

[0062] The preparation method of the medical dressing containing collagen comprises the following steps:

[0063] S1: Add sodium hyaluronate to deionized water at 50°C and stir for 15 to 30 minutes until it is completely dissolved to form a sodium hyaluronate solution;

[0064] S2: Slowly add carbomer to the sodium hyaluronate solution while stirring at high speed. The speed of high-speed stirring is 1000 rpm and the stirring time is 10 to 15 minutes to ensure that the carbomer is evenly dispersed.

[0065] S3: slowly add the antibacterial agent and the analgesic and anti-inflammatory agent to the solution of S2 in sequence, stirring at a low speed of 200-300 rpm, and after stirring evenly, slowly add glycerin and propylene glycol to the solution, stirring at a low speed of 200-300 rpm, until the mixture is evenly mixed;

[0066] S4: slowly add the bioactive glass powder to the mixed solution of S3, stirring at high speed, the speed of high-speed stirring is 1000 rpm, the stirring time is 10 to 15 minutes, and then use an ultrasonic disperser to evenly disperse the bioactive glass powder in the mixed solution of S3, the power of the ultrasonic disperser is 200 W, the frequency is 20 kHz, and the processing time is 12 to 15 minutes;

[0067] S5: Continue stirring the solution of S4 at a stirring speed of 500 rpm for 30 min until the solution is completely uniform and a stable mixed solution is formed;

[0068] S6: The prepared mixed solution is evenly coated on the hydrogel substrate. The coating method can be any one of spraying, dipping and brushing. The coating thickness is 0.8 to 1.2 mm. After drying, sterilization is performed to obtain a medical sodium hyaluronate dressing.

[0069] Experimental Group

[0070] 1. The medical sodium hyaluronate dressings prepared in the above three embodiments and medical dressings selected from the market were subjected to closed sensitization test, and the test results are as follows:

[0071]

[0072]

[0073] It can be seen from the above data that the medical sodium hyaluronate dressings prepared in Examples 1 to 3 do not irritate the skin and do not cause allergic reactions in the skin.

[0074] 2. Cytotoxicity test: The medical sodium hyaluronate dressings and silver ion dressings prepared in the above three embodiments were firstly extracted with DMEM culture medium for 48 hours, the negative control group was 10% fetal bovine serum DMEM, and the positive control group was 5% dimethyl sulfoxide; each experimental group was then co-cultured with fibroblast L929 cells for 72 hours; finally, the cytotoxicity was determined by MTT colorimetry, and the test results are shown below:

[0075] serial number Relative appreciation rate Cytotoxicity Grading Results Assessment Negative control 1.000 Level 0 Non-toxic Positive Control 0.193 Level 5 Severe toxicity Example 1 1.162 Level 0 Non-toxic Example 2 1.159 Level 0 Non-toxic Example 3 1.185 Level 0 Non-toxic Silver ion dressing 0.482 Level 3 Moderate toxicity

[0076] From the above data, it can be seen that after the medical sodium hyaluronate dressings prepared in Examples 1 to 3 were in contact with cells for 72 hours, the relative proliferation rate of the cells was greater than 100%, and there was no cytotoxicity, indicating that the medical dressings prepared by the invention have good biosafety and will not cause harm to the human body. At the same time, it can be found that silver ion dressings have obvious cytotoxicity, and long-term use of silver ion dressings is easy to deposit in human organs and cause harm to the human body.

[0077] In addition, the medical sodium hyaluronate dressing of the present invention significantly improves the moisturizing performance of the dressing by using low molecular weight sodium hyaluronate (250-350kDa). Low molecular weight sodium hyaluronate has stronger moisturizing ability and permeability, can quickly absorb and lock moisture, maintain a moist environment for the wound, promote cell proliferation and migration, and accelerate wound healing. In addition, sodium hyaluronate has good biocompatibility, almost no immunogenicity and toxicity, and is suitable for various types of wounds; a variety of natural antibacterial agents such as tea tree oil, cinnamon oil and honey, as well as analgesic and anti-inflammatory agents such as aloe extract, allantoin and licorice extract are used. These natural ingredients have a broad spectrum of antibacterial and anti-inflammatory effects, can effectively inhibit the growth and reproduction of bacteria, reduce the risk of infection, and reduce inflammatory reactions and relieve pain. Through the use of these natural ingredients, the present invention significantly reduces the use of antibiotics and silver ions, reduces the drug resistance and side effects that may be caused by excessive use of antibiotics and silver ions, and has good biosafety; by adding 45S5 bioactive glass powder, the mechanical properties and biological activity of the dressing are significantly improved. The particle size of bioactive glass powder is controlled at 1.0-5.0 μm, which can be evenly dispersed in the dressing, improving the mechanical strength and toughness of the dressing and making it more durable. At the same time, bioactive glass powder can release ions (such as calcium, silicon, phosphorus, etc.), promote the formation of extracellular matrix and cell proliferation, and accelerate wound healing. In addition, bioactive glass powder also has certain antibacterial and anti-inflammatory effects, further enhancing the comprehensive performance of the dressing; hydrogel is selected as the base material. Hydrogel has good air permeability and softness, can fit irregular wound surfaces, and reduce friction and discomfort. At the same time, the high water absorption and water retention of hydrogel can keep the wound moist and promote healing.

[0078] The preparation method of the medical dressing containing collagen provided by the present invention is simple and easy to implement. By precisely controlling the temperature, stirring speed and time of each step, the uniform dispersion and stable mixing of each component are ensured, and the final dressing has good skin compatibility and convenience in use. All components have undergone strict biosafety tests to ensure that they are non-cytotoxic, non-skin irritating, and will not cause damage to the human body, and are suitable for various clinical application scenarios.

[0079] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A medical sodium hyaluronate dressing, characterized in that: The invention comprises a substrate and a dressing coated on the substrate, wherein the dressing is composed of the following raw materials in parts by weight: 2-5 parts of sodium hyaluronate, 2-5 parts of carbomer, 1-3 parts of antibacterial agent, 1-3 parts of analgesic and anti-inflammatory agent, 15-20 parts of glycerol, 8-12 parts of bioactive glass powder, 5-8 parts of propylene glycol, and the balance is purified water.

2. A medical sodium hyaluronate dressing according to claim 1, characterized in that: The sodium hyaluronate is low molecular weight sodium hyaluronate, and its molecular weight is 250-350 kDa.

3. A medical sodium hyaluronate dressing according to claim 1, characterized in that: The bioactive glass powder is 45S5 bioactive glass, and 80% of the bioactive glass powder has a particle size of 1.0 to 5.0 μm.

4. A medical sodium hyaluronate dressing according to claim 3, characterized in that: The antibacterial agent is one or a combination of tea tree oil, cinnamon oil and honey.

5. A medical sodium hyaluronate dressing according to claim 1, characterized in that: The analgesic and anti-inflammatory agent is selected from aloe extract, allantoin and licorice extract, and the mass ratio of the aloe extract, allantoin and licorice extract is 3:1:

2.

6. A medical sodium hyaluronate dressing according to claim 1, characterized in that: The substrate is a hydrogel.

7. A method for preparing a medical sodium hyaluronate dressing according to any one of claims 1 to 6, characterized in that: The following steps are involved: S1: Add sodium hyaluronate to deionized water at 50°C and stir for 15 to 30 minutes until it is completely dissolved to form a sodium hyaluronate solution; S2: Slowly add carbomer into the sodium hyaluronate solution while stirring at high speed to ensure that the carbomer is evenly dispersed; S3: slowly add the antibacterial agent and the analgesic and anti-inflammatory agent to the solution of S2 in sequence, stirring while adding, and after stirring evenly, slowly add glycerin and propylene glycol to the solution, stirring while adding, until the mixture is evenly mixed; S4: slowly adding the bioactive glass powder into the mixed solution of S3, stirring at high speed, and then using an ultrasonic disperser to evenly disperse the bioactive glass powder in the mixed solution of S3; S5: Continue stirring the solution of S4 at a stirring speed of 500 rpm for 30 min until the solution is completely uniform and a stable mixed solution is formed; S6: The prepared mixed solution is evenly coated on the hydrogel substrate, and sterilized after drying to obtain a medical sodium hyaluronate dressing.

8. The method for preparing a medical sodium hyaluronate dressing according to claim 7, characterized in that: In S2 and S4, the rotation speed of the high-speed stirring is 1000 rpm, and the stirring time is 10 to 15 minutes; in S3, the entire stirring process adopts low-speed stirring, and the rotation speed is 200 to 300 rpm.

9. The method for preparing a medical sodium hyaluronate dressing according to claim 7, characterized in that: In S4, the power of the ultrasonic disperser is 200 W, the frequency is 20 kHz, and the processing time is 12 to 15 minutes.

10. The method for preparing a medical sodium hyaluronate dressing according to claim 7, characterized in that: In S6, the coating method may be any one of spraying, dipping and brushing, and the coating thickness is 0.8-1.2 mm.

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