Self-release oxygen and hydrogen mixed gas eye pad and preparation method thereof

Abstract

The invention discloses a self-release oxygen and hydrogen mixed gas eye pad and a preparation method thereof, and relates to the technical field of medical instruments, the self-release oxygen and hydrogen mixed gas eye pad comprises an airtight barrier layer, a gas-producing gas crystal chip layer and a breathable layer, the airtight barrier layer is arranged on the outer side of the gas-producing gas crystal chip layer, the gas-producing gas crystal chip layer is arranged on the outer side of the breathable layer, and the breathable layer is arranged on the outer side of the breathable layer. The airtight barrier layer is made of a plastic film material with excellent airtightness, the breathable layer is made of a non-woven fabric material with strong hydrophilicity and excellent breathability, and the gas-generating gas crystal chip layer is prepared by mixing an oxygen release material, a hydrogen release material, a slow release agent and an auxiliary additive. The structural design that the airtight barrier layer, the gas-producing gas crystal chip layer and the breathable layer are combined is adopted, the gas-producing gas crystal chip layer is formed by mixing calcium peroxide, aluminum powder, chitosan and other substances, the mixture can produce oxygen and hydrogen when meeting water, a high-oxygen and high-hydrogen microenvironment is formed around eyes, oxygen and hydrogen play a role at the same time, and therefore the eye protection effect is achieved. Harmful free radicals can be neutralized, inflammatory response can be regulated, and eye diseases can be prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and specifically relates to a self-releasing oxygen-hydrogen mixed gas eye patch and a preparation method thereof. Background Art

[0002] In today's digital age, people use electronic devices for a long time, and the burden on the eyes is increasing day by day. Problems such as eye fatigue, dryness, and inflammation are becoming more and more common. Traditional eye patches mainly relieve eye discomfort through physical moisturization or drug penetration, but it is difficult to fundamentally improve the eye physiological environment.

[0003] Oxygen is of great significance for maintaining the normal metabolism and function of eye tissues. Sufficient oxygen supply can not only promote aerobic respiration of cells and enhance cell vitality, but also reduce the risk of anaerobic bacteria infection. Hydrogen has significant antioxidant and anti-inflammatory properties, can neutralize free radicals in the eyes, reduce oxidative stress damage, and inhibit inflammatory reactions, and has a positive effect on preventing and improving various eye diseases. In summary, developing an eye patch that can autonomously release oxygen-hydrogen mixed gas has important practical significance for improving the micro gas environment of the eyes and enhancing the level of eye care.

[0004] Based on this, a self-releasing oxygen-hydrogen mixed gas eye patch and a preparation method thereof are now provided, which can eliminate the drawbacks of existing technical solutions. Summary of the Invention

[0005] The purpose of the present invention is to provide a self-releasing oxygen-hydrogen mixed gas eye patch and a preparation method thereof, so as to solve the problem that traditional eye patches in the background art are difficult to fundamentally improve the eye physiological environment.

[0006] To achieve the above purpose, the present invention provides the following technical solutions: A self-releasing oxygen-hydrogen mixed gas eye patch, including an airtight barrier layer, a gas-producing gas crystal chip layer, and a breathable layer. The airtight barrier layer is arranged on the outside of the gas-producing gas crystal chip layer, and the gas-producing gas crystal chip layer is arranged on the outside of the breathable layer; The airtight barrier layer is made of a plastic film material with excellent airtightness. The mass of the airtight barrier layer is set to 3% - 5% of the total mass of the eye patch. The breathable layer is made of a non-woven fabric material with strong hydrophilicity and good air permeability. The mass of the breathable layer is set to 8% - 12% of the total mass of the eye patch. The gas-producing gas crystal chip layer is prepared by mixing an oxygen-releasing material, a hydrogen-releasing material, a slow-release agent, and an auxiliary additive.

[0007] Preferably, the oxygen-releasing material is selected as calcium peroxide material, and the mass of the oxygen-releasing material is set to be 15% - 25% of the total amount of the gas-producing gas crystal chip layer. The hydrogen-releasing material is selected as surface-treated aluminum powder material, and the mass of the hydrogen-releasing material is set to be 5% - 10% of the total amount of the gas-producing gas crystal chip layer. The sustained-release agent is made of chitosan material, and the mass of the sustained-release agent is set to be 45% - 55% of the total amount of the gas-producing gas crystal chip layer. The auxiliary additives are a pH regulator and a moisturizer, and the masses of the auxiliary additives are set to be 8% - 12% and 7% - 10% of the total amount of the gas-producing gas crystal chip layer respectively.

[0008] Preferably, the pH regulator is sodium bicarbonate, and the moisturizer is glycerol.

[0009] Preferably, the preparation steps of the gas-producing gas crystal chip layer are as follows: Step 1: Through preprocessing the calcium peroxide material, dry calcium peroxide fine powder is obtained. Step 2: Add the nanoscale aluminum powder material into the ethanol solution containing stearic acid, and by means of ultrasonic dispersion and centrifugal separation, surface-treated aluminum powder is obtained. Step 3: Dissolve the chitosan material in the acetic acid solution, add a cross-linking agent, and after stirring, a gel-like chitosan substance is obtained. Step 4: Mix the dry calcium peroxide fine powder, the surface-treated aluminum powder, the chitosan substance and the auxiliary additives, and add a hydrogel matrix to obtain a paste-like mixture. Step 5: Uniformly coat the paste-like mixture on one side of the breathable layer to prepare and form the gas-producing gas crystal chip layer.

[0010] Preferably, Step 1 specifically includes the following steps: Grind the calcium peroxide sample until it is ground into fine powder with a particle size of 1 - 5 μm, pass through a 200 - 300 mesh sieve, put the sieved calcium peroxide fine powder into a vacuum drying oven, and dry it at a temperature of 50 - 60 °C for 2 - 3 h to obtain dry calcium peroxide fine powder.

[0011] Preferably, Step 2 specifically includes the following steps: Step 21: Add the nanoscale aluminum powder into the ethanol solution containing stearic acid. The average particle size of the nanoscale aluminum powder is 20 - 80 nm, and the mass ratio of the nanoscale aluminum powder to stearic acid is 10:1. Step 22: Carry out ultrasonic dispersion operation on the above solution at a temperature of 60 °C. The time of the ultrasonic dispersion operation is set to be 30 - 60 min until the surface of the aluminum powder is uniformly coated with stearic acid. Step 23: Separate the aluminum powder through centrifugation, immerse the aluminum powder in a cleaning tank containing an ethanol solution, and wash it 2 - 3 times until the excess stearic acid on the surface of the aluminum powder is removed. Then, perform a vacuum drying operation on the aluminum powder at a temperature of 50 - 60°C, and set the drying time to 2 - 3h to obtain the surface-treated aluminum powder.

[0012] Preferably, step 3 specifically includes the following steps: Step 31: Dissolve the chitosan material in an acetic acid solution with a mass concentration range of 1% - 2%. While stirring, raise the temperature to 50 - 60°C, and maintain the stirring time between 2 - 3h until the chitosan material is completely dissolved in the solution to obtain a chitosan solution with a mass concentration range of 2% - 5%. Step 32: Add glutaraldehyde as a cross-linking agent to the above solution. The mass ratio of the chitosan material to glutaraldehyde is 20:1, and stir for another 1 - 2h to fully cross-link the chitosan and form a chitosan gel with good sustained-release performance.

[0013] Preferably, the deacetylation degree of the chitosan material in step 31 is ≥90%.

[0014] Preferably, the thickness of the gas-producing gas crystal chip layer in step 5 is set to 0.6 - 1.2mm.

[0015] A preparation method of a self-releasing oxygen-hydrogen mixed gas eye patch, and the specific preparation steps are as follows: S1. Uniformly coat the above paste-like mixture on one side of the breathable layer to prepare a gas-producing gas crystal chip layer. Before the surface of the gas-producing gas crystal chip layer dries, cover the airtight barrier layer on the other side of the gas-producing gas crystal chip layer. S2. Make the airtight barrier layer, the gas-producing gas crystal chip layer, and the breathable layer closely adhere to each other through a hot pressing and compounding method. S3. Cut the adhered material into a shape that conforms to the size of the human eye circumference, and round the edges. S4. Pack the eye patch into a sealed packaging bag in an inert gas environment, evacuate the air and then perform a heat sealing operation to obtain the final self-releasing oxygen-hydrogen mixed gas eye patch.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The present invention provides a self-releasing oxygen-hydrogen mixed gas eye patch, which adopts a structural design combining an airtight barrier layer, a gas-producing gas crystal chip layer, and a breathable layer. The gas-producing gas crystal chip layer is composed of a mixture of substances such as calcium peroxide, aluminum powder, and chitosan. This mixture can produce oxygen and hydrogen when encountering water, forming a high-oxygen and high-hydrogen microenvironment around the eyes, providing sufficient oxygen supply for the eyes, promoting blood circulation in the eyes, and effectively preventing eye diseases. 2. The present invention is provided with an oxygen-releasing material, and the generated oxygen can significantly increase the oxygen content of the tissues around the eyes, effectively promote the aerobic respiration of eye cells, enhance cell vitality, thereby effectively improving the blood circulation of the eyes, and the sufficient oxygen can inhibit the growth of anaerobic bacteria, greatly reducing the risk of eye infections; 3. The present invention is provided with a hydrogen-releasing material, and hydrogen can selectively neutralize toxic free radicals such as hydroxyl free radicals in the eyes, significantly reduce the damage of oxidative stress to eye tissues, effectively inhibit the release of inflammatory factors, reduce the eye inflammatory reaction, and has a positive and significant effect on preventing and improving eye diseases such as eye fatigue, dry eye syndrome, and conjunctivitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic structural diagram of the eye patch of the present invention.

[0018] Figure 2 It is a preparation step diagram of the gas-producing gas crystal chip layer of the present invention.

[0019] Figure 3 It is a preparation step diagram of the eye patch of the present invention.

[0020] Annotation of reference numerals: airtight barrier layer 1, gas-producing gas crystal chip layer 2, breathable layer 3. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0021] In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the drawings and embodiments.

[0022] As Figures 1 - 3 shown, a self-releasing oxygen-hydrogen mixed gas eye patch includes an airtight barrier layer 1, a gas-producing gas crystal chip layer 2 and a breathable layer 3. The eye patch has a three-layer tightly bonded structure. The airtight barrier layer 1 is arranged outside the gas-producing gas crystal chip layer 2. The airtight barrier layer 1 can effectively prevent the internally generated gas from escaping, enabling the gas to be supplied directionally. The gas-producing gas crystal chip layer 2 is arranged outside the breathable layer 3. The breathable layer 3 is in direct contact with the eye skin, ensuring that the mixed gas can act on the eyes and their surroundings evenly and stably, so that the oxygen-hydrogen mixed gas can achieve the functions of promoting eye blood circulation, anti-inflammation, anti-infection, antioxidant and preventing eye diseases; The airtight barrier layer 1 is made of a plastic film material with excellent airtightness. The mass of the airtight barrier layer 1 is set to 3% - 5% of the total mass of the eye patch. The breathable layer 3 is made of a non-woven fabric material with strong hydrophilicity and good air permeability. The mass of the breathable layer 3 is set to 8% - 12% of the total mass of the eye patch. The gas-producing gas crystal chip layer 2 is prepared by mixing an oxygen-releasing material, a hydrogen-releasing material, a slow-release agent and an auxiliary additive.

[0023] The oxygen-releasing material is selected as calcium peroxide material, and the mass of the oxygen-releasing material is set to be 15% - 25% of the total amount of the gas-producing gas crystal chip layer 2. The hydrogen-releasing material is selected as the surface-treated aluminum powder material, and the mass of the hydrogen-releasing material is set to be 5% - 10% of the total amount of the gas-producing gas crystal chip layer 2. The slow-release agent is made of chitosan material, and the mass of the slow-release agent is set to be 45% - 55% of the total amount of the gas-producing gas crystal chip layer 2. The auxiliary additives are a pH regulator and a moisturizer, and the masses of the auxiliary additives are set to be 8% - 12% and 7% - 10% of the total amount of the gas-producing gas crystal chip layer 2 respectively. The pH regulator is sodium bicarbonate, and the moisturizer is glycerol.

[0024] The preparation steps of the gas-producing gas crystal chip layer 2 are as follows: Step 1: Through the pretreatment operation of the calcium peroxide material, dry calcium peroxide fine powder is obtained; Specifically, the calcium peroxide sample is ground until it is ground into fine powder with a particle size of 1 - 5 μm, and then sieved through a 200 - 300 mesh sieve to ensure that the material particle sizes are uniform. The sieved calcium peroxide fine powder is put into a vacuum drying oven and dried at a temperature of 50 - 60 °C for 2 - 3 h to obtain dry calcium peroxide fine powder; Step 2: The nano-aluminum powder material is added to the ethanol solution containing stearic acid, and the surface-treated aluminum powder is obtained by ultrasonic dispersion and centrifugal separation; Specifically, the nano-aluminum powder is added to the ethanol solution containing stearic acid. The average particle size of the nano-aluminum powder is 20 - 80 nm, and the mass ratio of the nano-aluminum powder to stearic acid is 10:1. The above solution is subjected to ultrasonic dispersion operation at a temperature of 60 °C, and the ultrasonic dispersion operation time is set to 30 - 60 min until the surface of the aluminum powder is uniformly coated with stearic acid, so that a layer of hydrophobic protective film is formed on the surface of the aluminum powder, effectively preventing the aluminum powder from reacting with water in advance before use. The aluminum powder is separated by centrifugal separation operation, and the aluminum powder is immersed in a cleaning tank containing ethanol solution and washed 2 - 3 times until the excess stearic acid on the surface of the aluminum powder is removed. The aluminum powder is subjected to vacuum drying operation at a temperature of 50 - 60 °C, and the drying time is set to 2 - 3 h; Step 3: The chitosan material is dissolved in the acetic acid solution, and a cross-linking agent is added, and after stirring, a gel-like chitosan substance is obtained; Specifically, the chitosan material is dissolved in an acetic acid solution with a mass concentration range of 1% to 2%. The degree of deacetylation of the chitosan material is ≥90%. While stirring, the temperature is raised to 50 - 60°C, and the stirring time is maintained between 2 - 3 hours until the chitosan material is completely dissolved in the solution, obtaining a chitosan solution with a mass concentration range of 2% to 5%. Glutaraldehyde is added to the above solution as a crosslinking agent. The chitosan molecular chain contains a large number of amino groups (-NH2), and glutaraldehyde has two aldehyde groups (-CHO). When an appropriate amount of glutaraldehyde is added as a crosslinking agent and the mass ratio of chitosan to glutaraldehyde is 20:1, the aldehyde groups of glutaraldehyde react with the amino groups of chitosan to form a Schiff base reaction, causing the carbon atom in the aldehyde group and the nitrogen atom in the amino group to form a C=N double bond through dehydration condensation, that is, the Schiff base structure (-CH=N-), enabling glutaraldehyde to form a crosslinking bridge between the chitosan molecular chains, connecting the original linear chitosan molecules and constructing a three-dimensional network structure. Stir again for 1 - 2 hours to fully crosslink the chitosan, forming a chitosan gel with good slow-release performance. The crosslinked structure can effectively control the contact rate between the oxygen-releasing material, hydrogen-releasing material, and water, ensuring that the eye patch can continuously and stably release the oxygen-hydrogen mixed gas; Step 4: Mix the dry calcium peroxide fine powder, surface-treated aluminum powder, chitosan substance, and auxiliary additives, and add a hydrogel matrix to obtain a paste-like mixture; Step 5: Uniformly coat the paste-like mixture on one side of the breathable layer 3 to prepare a gas-producing gas crystal chip layer 2, and set the thickness of the gas-producing gas crystal chip layer 2 to 0.6 - 1.2 mm.

[0025] The specific preparation steps of the self-releasing oxygen-hydrogen mixed gas eye patch are as follows: Uniformly coat the above paste-like mixture on one side of the breathable layer 3 to prepare a gas-producing gas crystal chip layer 2. Before the surface of the gas-producing gas crystal chip layer 2 dries, cover the other side of the gas-producing gas crystal chip layer 2 with the airtight barrier layer 1, and make the airtight barrier layer 1, the gas-producing gas crystal chip layer 2, and the breathable layer 3 fit tightly through hot pressing or bonding. When using the bonding method, add an adhesive layer to the above result. Cut the bonded material into a shape that conforms to the size of the human eye circumference, and round the edges. Pack the eye patch in a sealed packaging bag in an inert gas environment, such as a nitrogen or argon environment, evacuate and then perform a heat-sealing operation to obtain the final self-releasing oxygen-hydrogen mixed gas eye patch. Example 1

[0026] The preparation operation of the gas-producing gas crystal chip layer 2 is carried out according to the above steps 1-5. Among them, calcium peroxide is 17.0 g, nano-aluminum powder is 7.0 g, its particle size is 60 nm, chitosan raw material is 43.0 g, the breathable layer 3 uses a non-woven fabric material with strong hydrophilicity and good air permeability, its mass is 10.0 g, the airtight barrier layer 1 uses a polyethylene film material with excellent airtightness, its mass is 4.0 g, the pH regulator is sodium bicarbonate, its mass is 9.0 g, and glycerol is 7.0 g. The calcium peroxide pretreatment, aluminum powder surface treatment, and chitosan solution preparation operations are carried out in sequence according to the above preparation method to obtain the gas-producing gas crystal chip layer 2. Then, the airtight barrier layer 1, the gas-producing gas crystal chip layer 2, and the breathable layer 3 are closely bonded together by an assembly method to obtain a self-releasing oxygen-hydrogen mixed gas eye patch.

[0027] Performance tests are carried out on the prepared eye patch. The test contents include the release rate and duration of the oxygen-hydrogen mixed gas, as well as the promoting effect on eye blood circulation, the scavenging ability of free radicals, and the anti-inflammatory effect, etc. The test contents include simulation tests and volunteer tests, which are specifically as follows: 1. Simulation test: Simulate the real eye environment, accurately control the temperature to the average temperature of 32-34 °C of the skin around the human eye, and maintain the humidity in the appropriate range of 40% - 60% to ensure that the test conditions are highly close to the actual use scenario. In this environment, place the self-releasing oxygen-hydrogen mixed gas eye patch in a special closed detection device equipped with a high-precision gas flow sensor and a timer. After the detection is completed, summarize and analyze the multiple test data to draw a conclusion; The data shows that the oxygen release rate is stably in the range of 1.9-2.7 mL / min. In the initial stage, the oxygen release rate is relatively fast, about 2.7 mL / min. As time goes by, the rate gradually levels off and maintains at about 2.1 mL / min to continuously and stably supply oxygen to meet the eye's needs. The oxygen continuous release duration can reach 8-10 hours. After the 8th hour, the release rate has a downward trend but still remains above 1.9 mL / min to ensure a long-term effective oxygen supply; The hydrogen release rate fluctuates between 0.8-1.1 mL / min. Initially, the rate is close to 1.1 mL / min, and then it gradually slows down to around 1.0 mL / min. The hydrogen continuous release time is 6.0-8.0 hours. By the 6th hour, the hydrogen release rate drops to about 0.8 mL / min but still maintains a stable output, ensuring the persistence of the hydrogen's effect.

[0028] 50 volunteers aged 25 to 45 years old, with daily eye use time exceeding 8 hours and obvious eye fatigue symptoms, were screened out and randomly divided into an experimental group and a control group. All volunteers in the experimental group used self-releasing oxygen-hydrogen mixed gas eye patches, and all volunteers in the control group used ordinary eye patches, with 25 people in each group, to ensure that there were no significant differences between the two groups in terms of age, eye use habits, physical basic conditions, etc.; 2. Volunteer testing: Before the volunteers used the eye patches, a laser Doppler blood flowmeter was used to accurately measure and record the blood flow velocity in specific areas around their eyes, such as the outer canthus, inner canthus, and lower eyelid, to obtain basic data. The skin tissue samples around the eyes of the volunteers before using the eye patches were collected, and an electron paramagnetic resonance spectrometer (EPR) was used to determine the free radical content in the samples. The tear samples of the volunteers before using the eye patches were collected, and ELISA technology was used to detect the level of inflammatory factors in the tears. After the volunteers used the eye patches for 30 minutes, the blood flow velocity in the above areas was measured again using the same equipment and method, and the skin tissue samples and tear samples around the eyes of the volunteers after using the eye patches were collected to draw conclusions; The results showed that after the volunteers in the experimental group used the eye patches for 30 minutes, the average blood flow velocity around the eyes increased by 25% - 35%, the eye blood circulation was significantly improved, the level of inflammatory factors decreased, the free radical level in the samples was significantly reduced, and the eye fatigue symptoms were effectively relieved. Compared with before use, there were significant statistical differences (P < 0.05). After the control group used ordinary eye patches, although the blood flow velocity increased slightly, the increase was only 5% - 10%, and there was no statistical significance (P > 0.05).

[0029] Principle of use: Before using the eye patch, spray an appropriate amount of pure water on the eyes. After the eye patch comes into contact with the eyes, the moisture around the eyes will gradually penetrate through the breathable layer 3 into the gas-producing crystal chip layer 2. The calcium peroxide material in the gas-producing crystal chip layer 2 undergoes a decomposition reaction when it encounters water. Principle of use: Sodium bicarbonate is selected as the pH regulator in this eye patch. Before using the eye patch, spray an appropriate amount of pure water on the eyes. After the eye patch comes into contact with the eyes, the moisture around the eyes will gradually penetrate through the breathable layer 3 into the gas-producing crystal chip layer 2. The calcium peroxide material in the gas-producing crystal chip layer 2 undergoes a decomposition reaction when it encounters water. The chemical equation is: 2CaO2 + 2H2O ═ 2Ca(OH)2 + O2↑. The generated Ca(OH)2 will create an alkaline environment. At this time, sodium bicarbonate (NaHCO3) will react with Ca(OH)2. The chemical equation is: Ca(OH)2 + NaHCO3 ═ CaCO3↓ + NaOH + H2O (when Ca(OH)2 is in excess) to reduce the pH value and make the reaction system weakly alkaline (pH 8 - 9). Aluminum powder reacts under the action of water and the alkaline environment to produce hydrogen. The chemical equation is: 2Al + 2NaOH + 2H2O = 2NaAlO + 3H2↑. Chitosan, as a slow-release agent, precisely regulates the contact rate between the oxygen and hydrogen release materials and water through its own swelling, degradation, etc. processes to achieve the continuous and stable release of the oxygen-hydrogen mixed gas. At the same time, the reaction between sodium bicarbonate and Ca(OH)2 also helps to stabilize the pH value of the system and ensure the smooth progress of the entire gas-producing reaction. Example 2

[0030] Perform the preparation operation of the gas-producing crystal chip layer 2 according to the above steps 1 - 5. Among them, calcium peroxide is 22.0 g, nano-scale aluminum powder is 8.0 g, its particle size is 60 nm, the chitosan raw material is 54.0 g, the breathable layer 3 uses a non-woven fabric material with strong hydrophilicity and good air permeability, its mass is 12.0 g, the airtight barrier layer 1 uses a polyethylene film material with excellent airtightness, its mass is 3.0 g, sodium bicarbonate is selected as the pH regulator, its mass is 12.0 g, and glycerol is 10.0 g. Perform the calcium peroxide pretreatment, aluminum powder surface treatment, and chitosan solution preparation operations in sequence according to the above preparation method to obtain the gas-producing crystal chip layer 2. Then, tightly bond the airtight barrier layer 1, the gas-producing crystal chip layer 2, and the breathable layer 3 together through an assembly method to obtain the self-releasing oxygen-hydrogen mixed gas eye patch.

[0031] Conduct performance tests on the prepared eye patch. The test contents include the release rate and duration of the oxygen-hydrogen mixed gas, as well as the promotion effect on eye blood circulation, the scavenging ability of free radicals, and the anti-inflammatory effect, etc. The test contents include simulation tests and volunteer tests, as follows: 1. Simulation test: Simulate the real environment of the eye, accurately control the temperature to the average temperature of the skin around the human eye of 32~34℃, and maintain the humidity in the appropriate range of 40%~60% to ensure that the test conditions are highly close to the actual use scenario. In this environment, the self-releasing oxygen-hydrogen mixed gas eye patch is placed in a special closed detection device equipped with a high-precision gas flow sensor and timer. After the test, the multiple test data are summarized and analyzed to draw conclusions; The data showed that the oxygen release rate was stable in the range of 2.1-3.0 mL / min. In the initial stage, the oxygen release rate was relatively fast, about 3.0 mL / min. As time went on, the rate gradually stabilized and maintained at about 2.5 mL / min, so as to meet the needs of the eyes with a continuous and stable oxygen supply. The oxygen release time could reach 8-12 hours. After the 8th hour, the release rate showed a downward trend, but it still remained above 2.1 mL / min, ensuring long-term effective oxygen supply. The hydrogen release rate fluctuates between 0.9 and 1.4 mL / min. Initially, the rate is close to 1.4 mL / min, and then gradually slows down to around 1.1 mL / min. The continuous release time of hydrogen is 8.0 to 10.0 hours. By the 8th hour, the hydrogen release rate drops to about 0.9 mL / min, but still maintains a stable output, ensuring the durability of the hydrogen effect.

[0032] 2. Volunteer testing: 60 volunteers aged 25 to 45 years old with long-term excessive eye use, obvious symptoms of visual fatigue, and varying degrees of dry eyes and redness were selected. All volunteers used self-releasing oxygen-hydrogen mixed gas eye patches. Before the test, the volunteers underwent a comprehensive eye examination, and basic data such as vision, intraocular pressure, tear secretion, ocular surface inflammation indicators, and antioxidant enzyme activity were recorded in detail. During the trial, volunteers used the self-releasing oxygen-hydrogen mixed gas eye patch at the prescribed frequency every day for one week. During this week, the patients were asked and recorded their subjective eye feelings every day, such as the degree of relief of visual fatigue, changes in dryness, and the disappearance of redness and swelling. After the one-week trial period, the volunteers were re-examined comprehensively, and basic data such as vision, intraocular pressure, tear secretion, ocular surface inflammation indicators, and antioxidant enzyme activity were recorded in detail to draw conclusions; The data showed that up to 85% of the volunteers experienced significant improvement in their visual fatigue symptoms, as evidenced by improved visual clarity and greatly reduced soreness and pain after long-term eye use. In terms of eye appearance, patients who originally had symptoms of dry, red and swollen eyes had significantly alleviated their dryness, their tear secretion increased, the redness and swelling basically subsided, and ocular surface inflammation was effectively controlled.

[0033] Analyzing eye tissue samples, it was found that after using the eye patches, the antioxidant enzyme activities in the eyes of the volunteers were significantly enhanced. For example, the activities of key antioxidant enzymes such as superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) were significantly increased compared with those before the test. Moreover, the contents of indicators reflecting the degree of eye inflammation, such as the inflammatory factors interleukin-8 (IL-8) and C-reactive protein (CRP), all showed significant decreases. This indicates that the self-releasing oxygen-hydrogen mixture eye patches can effectively promote the function of the eye's antioxidant defense system, reduce eye inflammatory reactions, and comprehensively assist in the recovery of eye health, demonstrating excellent effectiveness in improving eye fatigue and relieving eye discomfort symptoms; Principle of use: The same as that in Example 1 The above is only the specific implementation manner of this application, but the protection scope of this application is not limited thereto. Any person skilled in the art within the technical scope disclosed in this application can easily think of changes or substitutions, which should all be covered within the protection scope of this application. Therefore, the protection scope of this application shall be subject to the protection scope of the claims.

Claims

1. A self-releasing oxygen-hydrogen mixed gas eye patch, comprising an airtight barrier layer (1), a gas-producing gas crystal chip layer (2) and a breathable layer (3). The airtight barrier layer (1) is disposed outside the gas-producing gas crystal chip layer (2), and the gas-producing gas crystal chip layer (2) is disposed outside the breathable layer (3). It is characterized in that The airtight barrier layer (1) is made of a plastic film material with excellent airtightness. The mass of the airtight barrier layer (1) is set to 3% - 5% of the total mass of the eye patch. The breathable layer (3) is made of a non-woven fabric with strong hydrophilicity, good breathability and good heat dissipation function. The mass of the breathable layer (3) is set to 8% - 12% of the total mass of the eye patch. The gas-producing gas crystal chip layer (2) is prepared by mixing an oxygen-releasing material, a hydrogen-releasing material, a slow-release agent and an auxiliary additive.

2. The self-releasing oxygen-hydrogen mixture eye patch according to claim 1, characterized in that, The oxygen-releasing material is selected as calcium peroxide material, and the mass of the oxygen-releasing material is set to 15% - 25% of the total amount of the gas-producing gas crystal chip layer (2). The hydrogen-releasing material is selected as surface-treated aluminum powder material, and the mass of the hydrogen-releasing material is set to 5% - 10% of the total amount of the gas-producing gas crystal chip layer (2). The slow-release agent uses chitosan material, and the mass of the slow-release agent is set to 45% - 55% of the total amount of the gas-producing gas crystal chip layer (2). The auxiliary additives are a pH regulator and a moisturizer, and the masses of the auxiliary additives are respectively set to 8% - 12% and 7% - 10% of the total amount of the gas-producing gas crystal chip layer (2).

3. The self-releasing oxygen-hydrogen mixture eye patch according to claim 2, wherein The pH regulator is set as sodium bicarbonate, and the moisturizer is set as glycerol.

4. The self-releasing oxygen-hydrogen mixture eye patch according to claim 3, characterized in that, The preparation steps of the gas-producing gas crystal chip layer (2) are as follows: Step 1: Through pretreatment of the calcium peroxide material, dry calcium peroxide fine powder is obtained. Step 2: Add the nano-level aluminum powder material into the ethanol solution containing stearic acid, and by means of ultrasonic dispersion and centrifugal separation, surface-treated aluminum powder is obtained. Step 3: Dissolve the chitosan material in the acetic acid solution, add a cross-linking agent, and stir to obtain a gel-like chitosan substance. Step 4: Mix the dry calcium peroxide fine powder, the surface-treated aluminum powder, the chitosan substance and the auxiliary additives, and add a hydrogel matrix to obtain a paste-like mixture. Step 5: Uniformly coat the paste-like mixture on one side of the breathable layer (3) to prepare and form the gas-producing gas crystal chip layer (2).

5. The self-oxygen-releasing hydrogen mixed gas eye patch according to claim 4, wherein The specific steps of Step 1 include the following steps: Grind the calcium peroxide sample until it is ground into fine powder with a particle size of 1 - 5 μm, pass through a 200 - 300 mesh sieve, put the sieved calcium peroxide fine powder into a vacuum drying oven, and dry it at a temperature of 50 - 60 °C for 2 - 3 h to obtain dry calcium peroxide fine powder.

6. The self-oxygen-releasing hydrogen mixed gas eye patch according to claim 5, characterized in that, The specific steps of Step 2 include the following steps: Step 21: Add the nano-level aluminum powder into the ethanol solution containing stearic acid. The average particle size of the nano-level aluminum powder is 20 - 80 nm, and the mass ratio of the nano-level aluminum powder to stearic acid is 10:

1. Step 22: Perform ultrasonic dispersion operation on the above solution at a temperature of 60 °C. The time of the ultrasonic dispersion operation is set to 30 - 60 min until the surface of the aluminum powder is uniformly coated with stearic acid. Step 23: Separate the aluminum powder by centrifugation, immerse the aluminum powder in a cleaning tank containing an ethanol solution, and wash it 2 - 3 times until the excess stearic acid on the surface of the aluminum powder is removed. Then, perform a vacuum drying operation on the aluminum powder at a temperature of 50 - 60°C for a drying time of 2 - 3 h to obtain the surface-treated aluminum powder.

7. The self-releasing oxygen-hydrogen mixture eye patch according to claim 6, characterized in that, The specific steps of step 3 are as follows: Step 31: Dissolve the chitosan material in an acetic acid solution with a mass concentration range of 1% - 2%. While stirring, raise the temperature to 50 - 60°C and maintain the stirring time between 2 - 3 h until the chitosan material is completely dissolved in the solution to obtain a chitosan solution with a mass concentration range of 2% - 5%. Step 32: Add glutaraldehyde as a cross-linking agent to the above solution. The mass ratio of the chitosan material to glutaraldehyde is 20:

1. Stir again for 1 - 2 h to fully cross-link the chitosan and form a chitosan gel with good sustained-release performance.

8. The self-releasing oxygen-hydrogen mixed gas eye patch according to claim 7, characterized in that, The degree of deacetylation of the chitosan material in step 31 is ≥90%.

9. The self-releasing oxygen-hydrogen mixed gas eye patch according to claim 8, characterized in that, The thickness of the gas-producing gas crystal chip layer (2) in step 5 is set to 0.6 - 1.2 mm.

10. A method for preparing the oxygen and hydrogen mixed gas self-releasing eye patch according to any one of claims 1-9, characterized in that, The specific preparation steps are as follows: S1. Uniformly coat the above paste-like mixture on one side of the breathable layer (3) to prepare and form the gas-producing gas crystal chip layer (2). Before the surface of the gas-producing gas crystal chip layer (2) dries, cover the gas-tight barrier layer (1) on the other side of the gas-producing gas crystal chip layer (2). S2. Make the gas-tight barrier layer (1), the gas-producing gas crystal chip layer (2), and the breathable layer (3) closely adhere to each other through a hot-pressing and compounding method. S3. Cut the adhered material into a shape that conforms to the size of the human eye circumference and round the edges. S4. Pack the eye patch into a sealed packaging bag in an inert gas environment, evacuate it, and then perform a heat-sealing operation to obtain the final self-releasing oxygen-hydrogen mixed gas eye patch.

Images