Physical cooling cold compress material for children and preparation method

Abstract

The invention discloses a physical cooling cold compress material for children and a preparation method, and belongs to the technical field of medical materials. The cold compress material is prepared from polyvinyl alcohol hydrogel, microencapsulated n-octadecane, glycerol, sodium carboxymethyl cellulose, a composite antibacterial agent (nano silver and chitosan), sodium hyaluronate, an aloe extract, citric acid and glutaraldehyde. The preparation method comprises the steps of phase change material microencapsulation, hydrogel matrix construction, functional component mixing, forming, post-treatment and the like. Through the design of the microencapsulated phase-change material and the composite antibacterial system, the dual functions of precise temperature control and long-acting antibacterial are realized, and meanwhile, the composite antibacterial temperature-controlled phase-change material has the advantages of skin friendliness, convenience in use, high biological safety and the like, and is suitable for physical cooling during fever of children.

Description

Technical Field

[0001] The present invention relates to the technical field of medical materials, and particularly relates to a physical cooling cold compress material for children and a preparation method thereof. Background Art

[0002] Fever in children is a common clinical symptom, and physical cooling is one of the important means to relieve fever. Traditional cold compress materials such as ice bags and wet towels have problems such as inaccurate temperature control, inconvenient use, and easy bacterial growth. In addition, children's skin is delicate, traditional cold compress materials are likely to cause skin irritation or frostbite, and lack long-term antibacterial function, there are certain safety hazards.

[0003] In recent years, hydrogel materials have been gradually applied to the cold compress field due to their good biocompatibility and water retention. However, existing hydrogel cold compress materials generally have problems such as short-term cooling effect, inaccurate temperature control, and insufficient antibacterial performance. Therefore, developing a physical cooling cold compress material for children with characteristics such as precise temperature control, long-term antibacterial, and skin-friendly has important clinical application value. Summary of the Invention

[0004] The purpose of the present invention is to provide a physical cooling cold compress material for children and a preparation method thereof.

[0005] To achieve the above object, the present invention is implemented according to the following technical scheme:

[0006] A physical cooling cold compress material for children of the present invention is made of polyvinyl alcohol hydrogel, microencapsulated n-octadecane, glycerol, sodium carboxymethyl cellulose, composite antibacterial agent, sodium hyaluronate, Rhodiola rosea extract, citric acid, and glutaraldehyde.

[0007] The composite antibacterial agent is made of nano silver and chitosan.

[0008] By weight, it contains 15 parts of the polyvinyl alcohol hydrogel, 10 parts of the microencapsulated n-octadecane, 5 parts of the glycerol, 2 parts of the sodium carboxymethyl cellulose, 1.8 parts of the composite antibacterial agent, 0.5 part of the sodium hyaluronate, 0.2 part of the Rhodiola rosea extract, 0.1 part of the citric acid, and 0.1 part of the glutaraldehyde; by weight, in the composite antibacterial agent, there are 0.3 part of nano silver and 1.5 parts of chitosan.

[0009] The phase change temperature of the microencapsulated n-octadecane is 28 - 32 °C; the particle size of the nano silver is 20 nm; the deacetylation degree of the chitosan ≥ 90%; the citric acid is adjusted to a pH of 5.5 - 6.5; the glutaraldehyde is a 0.05% solution.

[0010] The preparation method of the physical cooling cold compress material for children of the present invention includes the following steps:

[0011] S1: Heat n-octadecane to 35 °C until it completely melts, add 1% titanium dioxide, and stir and mix evenly to obtain the core material;

[0012] S2: Dissolve gelatin and gum arabic in deionized water at 60 °C in a ratio of 1:1 to prepare a 5% solution, and adjust the pH to 4.5 to obtain the wall material;

[0013] S3: Slowly drop the molten core material into the wall material solution at a volume ratio of 1:3, shear emulsify at 1000 rpm for 10 minutes, and cool to 10 °C to initiate phase separation to form microcapsules.

[0014] S4: Add 0.5% formaldehyde solution based on the amount of the core material for crosslinking and curing for 2 hours, centrifugally wash and then spray dry to obtain phase change microcapsules with a particle size of 50 - 100 μm.

[0015] S5: Add 15 g of polyvinyl alcohol powder to 80 ml of deionized water, stir in a water bath at 90 °C for 1 hour until completely dissolved, and cool to 40 °C to obtain polyvinyl alcohol hydrogel;

[0016] S6: Sequentially add glycerol, sodium carboxymethylcellulose, sodium hyaluronate, and aloe extract, and stir at 500 rpm for 20 minutes.

[0017] S7: Drop 5 ml of 0.05% glutaraldehyde solution, stir at a constant temperature of 45 °C for 30 minutes to form a three-dimensional network structure.

[0018] S8: Disperse silver nanoparticles in 10 ml of deionized water, and dissolve chitosan in 1% acetic acid solution.

[0019] S9: Sequentially add the phase change microcapsules, silver nanoparticle dispersion, and chitosan solution to the hydrogel matrix, and gradually reduce the stirring speed 800 rpm → 300 rpm to avoid breaking the microcapsules.

[0020] S10: Drop the citric acid solution, adjust the pH of the system to 5.8 ± 0.2, and let it stand for defoaming for 30 minutes.

[0021] S11: Inject the colloid into a special mold with a medical non-woven fabric on the surface, and control the thickness at 3 mm.

[0022] S12: Freeze at -20 °C for 2 hours, and then refrigerate at 4 °C for 12 hours to promote the stability of the gel structure.

[0023] S13: Sterilize by γ-ray irradiation with a dose of 25 kGy, vacuum package with an aluminum foil bag, and place a desiccant inside.

[0024] The beneficial effects of the present invention are:

[0025] The present invention is a physical cooling cold compress material for children and its preparation method. Compared with the prior art, the present invention has the following technical effects:

[0026] Precise temperature control: Through the phase change characteristics of microencapsulated n-octadecane, the cold compress material can maintain a stable low temperature in the range of 28 - 32 °C, avoiding local overcooling or overheating, and is suitable for use on the delicate skin of children.

[0027] Long-lasting antibacterial: The dual antibacterial mechanism of the composite antibacterial agent (nano silver + chitosan) can effectively inhibit the growth of bacteria, prevent secondary infections, and ensure the safety of use.

[0028] Skin friendliness: The addition of sodium hyaluronate and aloe vera extract enhances the moisturizing and anti-inflammatory properties of the material, reducing the irritation of the high-humidity environment to children's skin.

[0029] Convenient to use: The material is soft and conformable, with a moderate thickness, comfortable to use, reusable, economical and environmentally friendly.

[0030] High biological safety: All raw materials meet medical standards and pass cytotoxicity tests to ensure no irritation to children's skin. Specific implementation mode

[0031] The following and specific embodiments further describe the present invention. The illustrative embodiments and descriptions of the present invention are used to explain the present invention, but do not limit the present invention.

[0032] A physical cooling cold compress material for children of the present invention is made of polyvinyl alcohol hydrogel, microencapsulated n-octadecane, glycerol, sodium carboxymethyl cellulose, composite antibacterial agent, sodium hyaluronate, aloe vera extract, citric acid, and glutaraldehyde.

[0033] The composite antibacterial agent is made by compounding nano silver and chitosan.

[0034] By weight, it contains 15 parts of the polyvinyl alcohol hydrogel, 10 parts of the microencapsulated n-octadecane, 5 parts of the glycerol, 2 parts of the sodium carboxymethyl cellulose, 1.8 parts of the composite antibacterial agent, 0.5 part of the sodium hyaluronate, 0.2 part of the aloe vera extract, 0.1 part of the citric acid, and 0.1 part of the glutaraldehyde; by weight, in the composite antibacterial agent, there are 0.3 parts of nano silver and 1.5 parts of chitosan.

[0035] The phase change temperature of the microencapsulated n-octadecane is 28 - 32 °C; the particle size of the nano silver is 20 nm; the deacetylation degree of the chitosan is ≥90%; the pH of the citric acid is adjusted to 5.5 - 6.5; the glutaraldehyde is a 0.05% solution.

[0036] The preparation method of the physical cooling cold compress material for children of the present invention includes the following steps:

[0037] S1: Heat n-octadecane to 35 °C until it completely melts, add 1% titanium dioxide, and stir and mix evenly to obtain the core material;

[0038] S2: Dissolve gelatin and gum arabic in deionized water at 60°C in a ratio of 1:1 to prepare a 5% solution, and adjust the pH to 4.5 to obtain the wall material.

[0039] S3: Slowly drop the molten core material into the wall material solution at a volume ratio of 1:3, emulsify it at high speed with a shear rate of 1000 rpm for 10 minutes, and cool it to 10°C to initiate phase separation to form microcapsules.

[0040] S4: Add a 0.5% formaldehyde solution based on the amount of the core material for cross-linking and curing for 2 hours, wash by centrifugation, and then spray-dry to obtain phase change microcapsules with a particle size of 50 - 100 μm.

[0041] S5: Add 15 g of polyvinyl alcohol powder to 80 ml of deionized water, stir in a water bath at 90°C for 1 hour until completely dissolved, and cool to 40°C to obtain a polyvinyl alcohol hydrogel.

[0042] S6: Sequentially add glycerol, sodium carboxymethylcellulose, sodium hyaluronate, and aloe extract, and stir at 500 rpm for 20 minutes.

[0043] S7: Drop 5 ml of a 0.05% glutaraldehyde solution, stir at a constant temperature of 45°C for 30 minutes to form a three-dimensional network structure.

[0044] S8: Disperse silver nanoparticles in 10 ml of deionized water, and dissolve chitosan in a 1% acetic acid solution.

[0045] S9: Sequentially add the phase change microcapsules, silver nanoparticle dispersion, and chitosan solution to the hydrogel matrix, and gradually reduce the stirring speed from 800 rpm to 300 rpm to avoid breaking the microcapsules.

[0046] S10: Drop a citric acid solution, adjust the pH of the system to 5.8 ± 0.2, and let it stand for defoaming for 30 minutes.

[0047] S11: Inject the colloid into a special mold with a medical non-woven fabric on the surface, and control the thickness at 3 mm.

[0048] S12: Freeze at -20°C for 2 hours, and then refrigerate at 4°C for 12 hours to promote the stability of the gel structure.

[0049] S13: Sterilize by γ-ray irradiation with a dose of 25 kGy, vacuum package with an aluminum foil bag, and place a desiccant inside.

[0050]

[0051]

[0052] Key parameters and quality control:

[0053] Phase change performance: The phase change temperature measured by DSC is 28 - 32°C, and the latent heat is ≥180 J / g.

[0054] Antibacterial effect: According to the ISO 22196 standard, the antibacterial rate against Staphylococcus aureus and Escherichia coli is ≥99.9%.

[0055] Biological safety: Passed the ISO 10993 - 5 cytotoxicity test (the cell survival rate of the leaching solution is ≥80%).

[0056] Duration of use: It can continuously cool down for 4 - 5 hours at 25°C, and the number of repeated uses is ≥10 times.

[0057] Equipment requirements: It requires conventional chemical engineering equipment such as high - speed emulsifiers, vacuum degassing machines, and spray drying towers.

[0058] Raw material specifications: The purity of nano - silver is ≥99.9%, the degree of alcoholysis of PVA is 88%, and the purity of the phase - change material is ≥98%.

[0059] Operation protection: The addition stage of glutaraldehyde needs to be carried out in a fume hood, and the operator should wear goggles and chemical - resistant gloves.

[0060] Example: Preparation and performance test of a physical cooling cold compress material for children

[0061] 1. Material preparation

[0062] Prepare raw materials according to the following parts by weight:

[0063] Polyvinyl alcohol hydrogel: 15 parts

[0064] Microencapsulated n - octadecane: 10 parts

[0065] Glycerol: 5 parts

[0066] Sodium carboxymethyl cellulose: 2 parts

[0067] Compound antibacterial agent (0.3 parts of nano - silver + 1.5 parts of chitosan): 1.8 parts

[0068] Sodium hyaluronate: 0.5 part

[0069] Aloe vera extract: 0.2 part

[0070] Citric acid: 0.1 part

[0071] Glutaraldehyde (0.05% solution): 0.1 part

[0072] 2. Preparation steps

[0073] Step 1: Heat n - octadecane to 35°C until it completely melts, add 1% titanium dioxide, and stir and mix evenly to obtain the core material.

[0074] Step 2: Dissolve gelatin and gum arabic in deionized water at 60 °C in a 1:1 ratio to prepare a 5% solution, adjust the pH to 4.5, and obtain the wall material.

[0075] Step 3: Slowly drop the molten core material into the wall material solution at a volume ratio of 1:3, emulsify at high speed with a shear rate of 1000 rpm for 10 minutes, cool to 10 °C to initiate phase separation, and form microcapsules.

[0076] Step 4: Add a 0.5% formaldehyde solution based on the amount of the core material for crosslinking and curing for 2 hours, centrifugally wash, and then spray dry to obtain phase change microcapsules with a particle size of 50 - 100 μm.

[0077] Step 5: Add 15 g of polyvinyl alcohol powder to 80 ml of deionized water, stir in a water bath at 90 °C for 1 hour until completely dissolved, and cool to 40 °C to obtain a polyvinyl alcohol hydrogel.

[0078] Step 6: Sequentially add glycerol, sodium carboxymethylcellulose, sodium hyaluronate, and aloe extract, and stir at 500 rpm for 20 minutes.

[0079] Step 7: Dropwise add 5 ml of a 0.05% glutaraldehyde solution, stir at a constant temperature of 45 °C for 30 minutes to form a three-dimensional network structure.

[0080] Step 8: Disperse silver nanoparticles in 10 ml of deionized water, and dissolve chitosan in a 1% acetic acid solution.

[0081] Step 9: Sequentially add the phase change microcapsules, silver nanoparticle dispersion, and chitosan solution to the hydrogel matrix, gradually reduce the stirring speed (800 rpm → 300 rpm), and avoid breaking the microcapsules.

[0082] Step 10: Dropwise add a citric acid solution, adjust the pH of the system to 5.8 ± 0.2, and let it stand for defoaming for 30 minutes.

[0083] Step 11: Inject the colloid into a special mold with a medical non-woven fabric on the surface, and control the thickness at 3 mm.

[0084] Step 12: Freeze at -20 °C for 2 hours, and then refrigerate at 4 °C for 12 hours to promote the stability of the gel structure.

[0085] Step 13: Sterilize by γ-ray irradiation with a dose of 25 kGy, vacuum package in an aluminum foil bag, and place a desiccant inside.

[0086] 3. Performance Testing

[0087] Phase Change Performance: Tested by differential scanning calorimetry (DSC), the phase change temperature is 28 - 32 °C, and the latent heat is 185 J / g.

[0088] Antibacterial performance: Tested according to ISO 22196 standard, the antibacterial rates against Staphylococcus aureus and Escherichia coli are both ≥99.9%.

[0089] Biological safety: Passed the ISO 10993-5 cytotoxicity test, and the cell survival rate of the extract is 85%, meeting the safety standards for medical materials.

[0090] Duration of use: In an environment of 25°C, the cold compress material can continuously cool down for 4.5 hours, and its performance shows no obvious decline after being reused 10 times.

[0091] The technical solution of the present invention is not limited to the limitations of the above specific embodiments. Any technical deformation made according to the technical solution of the present invention falls within the protection scope of the present invention.

Claims

1. A physical cooling cold compress material for children, characterized by: It is made of polyvinyl alcohol hydrogel, microencapsulated n-octadecane, glycerol, sodium carboxymethyl cellulose, composite antibacterial agent, sodium hyaluronate, Luhui extract, citric acid and glutaraldehyde.

2. The physical cooling cold compress material for children according to claim 1, characterized in that: The composite antibacterial agent is prepared by composite nano silver and chitosan.

3. The physical cooling cold compress material for children according to claim 2, characterized in that: In parts by weight, it contains 15 parts of the polyvinyl alcohol hydrogel, 10 parts of the microencapsulated n-octadecane, 5 parts of glycerol, 2 parts of sodium carboxymethyl cellulose, 1.8 parts of the composite antibacterial agent, 0.5 parts of sodium hyaluronate, 0.2 parts of Luhui extract, 0.1 parts of citric acid, and 0.1 parts of glutaraldehyde; in parts by weight, the composite antibacterial agent contains 0.3 parts of nanosilver and 1.5 parts of chitosan.

4. The physical cooling cold compress material for children according to claim 3, characterized in that: The phase transition temperature of the microencapsulated n-octadecane is 28-32° C.; the particle size of the nanosilver is 20 nm; the deacetylation degree of the chitosan is ≥90%; the pH of the citric acid is adjusted to 5.5-6.5; and the glutaraldehyde is a 0.05% solution.

5. A method for preparing the physical cooling cold compress material for children as claimed in claim 4, characterized in that: The following steps are involved: S1: heat n-octadecane to 35°C to completely melt, add 1% titanium dioxide, stir and mix evenly to obtain a core material; S2: Dissolve gelatin and gum arabic in 60° C. deionized water in a ratio of 1:1 to prepare a 5% solution, and adjust the pH to 4.5 to prepare the wall material; S3: The core material melt was slowly dripped into the wall material solution at a volume ratio of 1:3, and high-speed shear emulsification was performed at 1000 rpm for 10 minutes. The temperature was lowered to 10°C to induce phase separation and form microcapsules. S4: adding 0.5% formaldehyde solution of the core material for cross-linking and curing for 2 hours, centrifugally washing and spray drying to obtain phase change microcapsules with a particle size of 50-100 μm. S5: Add 15 g of polyvinyl alcohol powder to 80 ml of deionized water, stir in a 90 °C water bath for 1 hour until completely dissolved, and cool to 40 °C to obtain polyvinyl alcohol hydrogel; S6: Add glycerol, sodium carboxymethyl cellulose, sodium hyaluronate and aloe extract in sequence, and stir at 500 rpm for 20 minutes. S7: 5 ml of 0.05% glutaraldehyde solution was added dropwise and stirred at 45° C. for 30 minutes to form a three-dimensional network structure. S8: Disperse nanosilver in 10 ml of deionized water and dissolve chitosan in 1% acetic acid solution. S9: Add phase change microcapsules, nanosilver dispersion, and chitosan solution to the hydrogel matrix in sequence, and gradually reduce the stirring speed from 800 rpm to 300 rpm to avoid microcapsule rupture. S10: Add citric acid solution dropwise to adjust the pH of the system to 5.8±0.2, and let it stand for degassing for 30 minutes. S11: Inject the colloid into a special mold covered with medical non-woven fabric, with the thickness controlled at 3 mm. S12: Freeze at -20°C for 2 hours and then refrigerate at 4°C for 12 hours to promote the stability of the gel structure. S13: Sterilized by γ-ray irradiation at a dose of 25 kGy, vacuum packaged in aluminum foil bag, with built-in desiccant.

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