An eye care patch for relieving eye dryness, visual fatigue and myopia and a preparation method thereof

Abstract

This invention provides an eye patch for relieving dry eyes, visual fatigue, and myopia, and its preparation method. The eye patch comprises, from the outside to the inside, an isolation layer, a solution carrier layer, and a non-woven fabric; the solution carrier layer is a breathable membrane impregnated with an eye-protecting composition. The eye-protecting composition is characterized by including matrix components such as glycerin, carbomer, and sodium alginate, as well as active ingredients in specific proportions such as squalene, ginger root extract, *Isodon japonicus* extract, *Cyperus rotundus* lysate extract, aesculin, lutein esters, zeaxanthin, B vitamins, and sodium hyaluronate. This combination of active ingredients, through multi-target synergistic action, can effectively relieve dryness, improve microcirculation, protect the retina, and slow the progression of myopia. This invention also provides a method for preparing the eye patch, including steps such as composition formulation, impregnation, compounding, and molding. This eye patch has the advantages of comfortable application, stable ingredients, and synergistic effects.

Description

Technical Field

[0001] This invention relates to the field of eye care product technology, and in particular to an eye patch for relieving dry eyes, visual fatigue and myopia, and its preparation method. Background Technology

[0002] With the advancement of information technology in modern society, the widespread use of electronic devices such as mobile phones, computers, and tablets has significantly increased the intensity of eye use among people. Coupled with factors such as dry air-conditioned environments and reduced outdoor activity time, eye health problems are becoming increasingly prominent. Dry eye syndrome, visual fatigue, and myopia have become globally prevalent eye diseases, with particularly high incidence rates among young and middle-aged adults and adolescents.

[0003] Dry eye syndrome, a common ocular surface disease, is characterized by decreased tear film stability, ocular surface inflammation, and corneal epithelial damage. Clinical symptoms include dryness, foreign body sensation, and burning sensation. Visual fatigue is often associated with prolonged ciliary muscle contraction, ocular surface microcirculation disorders, and oxidative stress damage, manifesting as eye strain, blurred vision, and dizziness, severely impacting work and daily life efficiency. Simultaneously, the incidence of myopia among adolescents is significantly increasing, exceeding 50% in my country. Myopia progression is closely related to retinal blue light damage, ciliary muscle spasm, and ocular surface malnutrition. Current interventions primarily rely on optical correction, lacking safe and effective topical care products.

[0004] To address the aforementioned eye problems, various eye care products have emerged in the current technology, mainly including the following types: First, artificial tears or basic moisturizing eye patches for relieving dryness. Their main ingredients are often moisturizers such as sodium hyaluronate and polyvinyl alcohol, offering relatively limited functionality and lacking effective intervention for eye strain and myopia progression caused by ciliary muscle spasm. Second, ordinary eye patches containing cooling agents such as menthol and borneol. While providing temporary relief, their active ingredients are simple, have poor permeability, and their effects are superficial and short-lived. They also cannot provide protection against key aspects of myopia development, such as scleral hypoxia and retinal light damage. Third, a few eye care products containing single plant extracts or vitamins, but their ingredient combinations lack systematicity and synergy, making it difficult to simultaneously address multiple issues such as dry eyes, accommodative fatigue, and myopia prevention. In summary, existing eye care products typically suffer from the following shortcomings: First, their functions tend to be singular, with most products focusing only on basic functions such as moisturizing or cooling, failing to address the combined needs of dry eyes, eye fatigue, and myopia control. Second, in terms of dosage form, traditional eye patch carrier materials struggle to achieve an ideal balance between breathability and ingredient retention. Insufficient breathability can lead to localized dampness and heat, while excessive breathability accelerates the evaporation of active ingredients. More importantly, regarding the compatibility of active ingredients, current technologies largely remain at the stage of simply layering known active ingredients, lacking in-depth research on the synergistic effects between components, particularly lacking scientifically formulated solutions that can simultaneously act on multiple physiological pathways such as tear film stabilization, ciliary muscle regulation, improvement of periocular microcirculation, and protection against retinal photodamage. Summary of the Invention

[0005] In view of this, the present invention proposes an eye patch for relieving dry eyes, visual fatigue and myopia, and a method for preparing the same, thereby solving the above problems.

[0006] The technical solution of the present invention is implemented as follows: an eye patch for relieving dry eyes, visual fatigue and myopia, comprising, from the outside to the inside, an isolation layer, a solution carrier layer and a non-woven fabric; the solution carrier layer is a breathable membrane impregnated with an eye-protecting composition; the eye-protecting composition comprises the following components in weight percentage: glycerin 5-8%, carbomer 0.1-0.3%, ethylene glycol 2-4%, sodium alginate 0.5-1.2%, disodium edetate 0.05-0.1%, triethanolamine 0.2-0.5%, hexanediol 1-3%, p-hydroxyacetophenone 0.1-0.2%, and a pharmaceutically acceptable solvent.

[0007] Preferably, the isolation layer is made of polyethylene film with a thickness of 20-50 μm, the breathable membrane is a medical breathable membrane with a thickness of 0.08-0.12 mm, and the solution loading is controlled at 1.2-1.5 g / cm³. 2 The appropriate balance between air permeability and thickness helps prevent eye discomfort while maintaining the retention rate of effective components in the solution layer.

[0008] Preferably, the eye-protecting composition further comprises the following components in weight percentage: squalene 0.3-1.2%, ginger flower root extract 2-8%, rice bran extract 1-3%, cyperus rotundus lysate extract 0.5-1.2%, aesculin 0.05-0.8%, lutein ester 2-6%, zeaxanthin 1-4%, B vitamins 0.2-1.5%, and sodium hyaluronate 0.5-3.0%.

[0009] More preferably, the ginger flower root extract is obtained by drying and pulverizing ginger flower roots, then extracting them with supercritical CO2 at a pressure of 35-45 MPa and a temperature of 40-50℃ for 1-3 hours. The extract is purified by chromatography, and the eluent is collected, concentrated, and dried to obtain an extract powder with a total flavonoid content of ≥28%.

[0010] More preferably, the *Solanum tuberosum* extract is prepared by drying and pulverizing the whole *Solanum tuberosum* herb, adding 7-9 times its weight of 60-70% v / v ethanol solution, and co-extracting at ultrasonic power 250-300W, microwave power 120-150W, and temperature 55-65℃ for 1.5h. After filtration, the extract is concentrated under reduced pressure until no alcohol odor remains, purified by chromatography, and the target elution peak is collected, concentrated, and freeze-dried to obtain an extract powder with a total polyphenol content ≥32% and a flavonoid content ≥25%.

[0011] Preferably, the extract of *Cyperus cytokines* lysate is prepared by the following method: (1) Cell culture: Take the bacteria for culture to obtain fermentation broth, centrifuge the fermentation broth and collect the cell precipitate; (2) Compound cell disruption: The bacterial cells are resuspended in cell disruption buffer to obtain a bacterial suspension, and then a compound enzyme is added for enzymatic hydrolysis; (3) Disruption and extraction: The bacterial suspension after enzymatic hydrolysis is subjected to intermittent ultrasonic treatment to obtain the bacterial cell disruption liquid; (4) Separation and purification: The bacterial cell lysate is subjected to solid-liquid separation, the liquid portion containing soluble active ingredients is collected, and then purified and concentrated to obtain the bacterial cell lysate extract.

[0012] More preferably, The culture conditions described in step (1) are: 25-30℃, pH 6.5-7.5, and shaking culture for 48-72 hours; the centrifugation conditions are: 4℃, 8000-12000rpm, and centrifugation for 15-20 minutes. The cell disruption buffer in step (2) is a phosphate buffer with a pH of 5.5-6.5 and a concentration of 0.02-0.05M; the ratio of bacterial cells to cell disruption buffer in g / mL is 1:5-15; the complex enzyme is lysozyme and snail enzyme in a mass ratio of 1:0.8-1.2; the amount of enzyme added is 0.5-1.0% of the bacterial suspension mass; the enzymatic hydrolysis temperature is 35-40℃; the pH is 5.5-6.5; and the duration is 2-4 hours. The ultrasonic power in step (3) is 300-500W, with a working time of 2 seconds and an interval of 3 seconds, for a total time of 10-15 minutes; The solid-liquid separation in step (4) is carried out by ultracentrifugation at 3-5℃ and 12000-18000rpm for 25-35 minutes, collecting the supernatant and filtering it through a 0.22μm filter membrane for sterilization. The concentration is carried out by ultrafiltration concentration using an ultrafiltration membrane with a molecular weight cutoff of 3kDa.

[0013] Preferably, the B vitamins are composed of vitamin B1, vitamin B6, and vitamin B12 in a weight ratio of 2:1:1.

[0014] This invention also provides a method for preparing eye patches, comprising the following steps: S1. Preparation of the composition: S11. Take a pharmaceutically acceptable solvent, preferably deionized water, and stir at a temperature of 35-45℃ and a speed of 300-500 rpm. Add carbomer and sodium alginate, and continue stirring for 1.5-2.5 hours until completely dissolved to form a gel matrix. S12. Add glycerol, ethylene glycol, hexanediol and disodium edetate to the gel matrix in sequence, stir for 30-40 min, then add triethanolamine dropwise to adjust the pH of the system to 6.0-7.0, and stir for 10-15 min. S13. Cool to 30-34℃, add p-hydroxyacetophenone, stir for 20-30 minutes to dissolve, then add squalene, ginger root extract powder, rice straw extract powder, cyperus rotundus lysate extract powder, aesculin, lutein ester, zeaxanthin, B vitamins and sodium hyaluronate in sequence, and ultrasonically disperse at 150-250W for 40-60 minutes to obtain the eye protection composition; S2, Solution carrier layer impregnation: Immerse the breathable membrane in the eye protection composition prepared in step S1, and impregnate it at a temperature of 25-30℃ for 20-30 minutes to form a solution carrier layer; S3, Lamination and Composite: Non-woven fabric, solution carrier layer and isolation layer are sequentially laminated under a pressure of 0.1-0.3MPa and a temperature of 30-35℃ to obtain composite substrate; S4. Molding: The composite substrate obtained in step S3 is cut and shaped to obtain the eye patch.

[0015] The eye patch of the present invention is used in the preparation of products for relieving dry eyes, visual fatigue and myopia.

[0016] Compared with the prior art, the beneficial effects of the present invention are: This invention's eye patch, by limiting the specific thickness and solution loading of the isolation layer and solution carrier layer, achieves excellent adhesion, breathability, and liquid-carrying capacity, effectively avoiding a stuffy feeling during use while ensuring the stable retention and continuous release of active ingredients. Furthermore, through the scientific compounding of basic moisturizing and stabilizing components and multiple core active ingredients, a multi-target synergistic system is constructed to relieve dryness, reduce fatigue, and intervene in myopia. Among these, squalene promotes cell regeneration and repair and improves local microcirculation; ginger flower root extract and rice bran extract broadly and efficiently scavenge free radicals and resist oxidative stress damage. Simultaneously, it effectively inhibits the expression of key inflammatory factors, specifically soothing periorbital tissue inflammation caused by prolonged eye use or dryness. Aesculin improves microcirculation, *Cyperus diffusa* lysate extract optimizes energy metabolism in ciliary muscle and scleral cells, promoting tissue repair; and lutein esters filter harmful blue light and quench free radicals such as singlet oxygen induced by light. The components complement each other and have synergistic effects, effectively solving the technical defects of existing products with single-target action and limited efficacy. Detailed Implementation

[0017] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0018] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0019] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0020] The nonwoven fabric used in this embodiment of the invention is medical-grade degreased cotton nonwoven fabric with a basis weight of 25-30 g / m². 2 .

[0021] The *Glaciecola agarilytica* strain used in this embodiment of the invention is *Glaciecola agarilytica*, which is sourced from the China Marine Microbial Culture Collection Center. Its Latin name is *Glaciecola agarilytica*, and its accession number is MCCC 1K00897.

[0022] Example 1 1. The eye-protecting composition comprises the following components in weight percentages: The formula contains 5% glycerol, 0.1% carbomer, 2% ethylene glycol, 0.5% sodium alginate, 0.05% disodium edetate, 0.2% triethanolamine, 1% hexanediol, 0.1% p-hydroxyacetophenone, 0.3% squalene, 2% ginger flower root extract, 1% *Isodon japonicus* extract, 0.5% *Cyperus rotundus* lysate extract, 0.05% aescin, 2% lutein ester, 1% zeaxanthin, 0.2% B vitamins, 0.5% sodium hyaluronate, and the balance being deionized water. The B vitamins consist of vitamin B1, vitamin B6, and vitamin B12 in a weight ratio of 2:1:1.

[0023] 2. Preparation of core components Ginger flower root extract: After drying and pulverizing ginger flower roots, supercritical CO2 extraction was performed at a pressure of 40 MPa and a temperature of 45℃ for 2 hours. The extract was purified by chromatography, and the eluent was collected, concentrated and dried to obtain an extract powder with a total flavonoid content of ≥28%.

[0024] Rice fern extract: The whole rice fern herb was dried and pulverized, and 8 times its weight of 65% v / v ethanol solution was added. The mixture was then extracted for 1.5 h under ultrasonic power of 300 W, microwave power of 150 W, and temperature of 60 °C. The extract was filtered and concentrated under reduced pressure until no alcohol odor was detected. The extract was purified by chromatography, and the target elution peak was collected, concentrated, and freeze-dried to obtain an extract powder with a total polyphenol content ≥32% and a flavonoid content ≥25%.

[0025] Extract of *Cyperus bisporus* lysate: (1) Cell culture: Inoculate the bacteria into a low-temperature fermentation medium and culture it with shaking at 28°C and pH=7 for 60 hours. Centrifuge the fermentation broth at 4°C and 10,000 rpm for 18 minutes, collect the cell precipitate, and wash it with pre-cooled phosphate buffer.

[0026] (2) Compound cell disruption: The bacterial body was resuspended in phosphate buffer solution with pH=6 and concentration of 0.03M at a material-to-liquid ratio of 1:10 g / mL to obtain a bacterial suspension. 0.8% of the bacterial suspension mass of the compound enzyme (lysozyme: snailase=1:1) was added and enzymatically hydrolyzed at 38℃ and pH=6 for 3 hours.

[0027] (3) Crushing and extraction: The enzymatically hydrolyzed bacterial suspension was placed in an ice bath and subjected to intermittent ultrasonic treatment at 400W power (working for 2 seconds and intermittently for 3 seconds) for 12 minutes;

[0028] (4) Separation and purification: The bacterial cell lysate was centrifuged at 4°C and 15,000 rpm for 30 minutes. The supernatant was collected and filtered through a 0.22 μm filter membrane for sterilization. The supernatant was concentrated using an ultrafiltration membrane with a molecular weight cutoff of 3 kDa and then freeze-dried to obtain the extract powder.

[0029] Example 2 1. The eye-protecting composition comprises the following components in weight percentages: The formula contains 8% glycerol, 0.3% carbomer, 4% ethylene glycol, 1.2% sodium alginate, 0.1% disodium edetate, 0.5% triethanolamine, 3% hexanediol, 0.2% p-hydroxyacetophenone, 1.2% squalene, 8% ginger flower root extract, 3% *Ipomoea batatas* extract, 1.2% *Cyperus rotundus* lysate extract, 0.8% aescin, 6% lutein ester, 4% zeaxanthin, 1.5% B vitamins, 3.0% sodium hyaluronate, and the balance being deionized water. The B vitamins consist of vitamin B1, vitamin B6, and vitamin B12 in a weight ratio of 2:1:1.

[0030] 2. Preparation of core components The preparation methods for ginger flower root extract, rice straw extract, and Cyperus rotundus lysate extract are the same as in Example 1.

[0031] Example 3 1. The eye-protecting composition comprises the following components in weight percentages: The formula contains 6.5% glycerol, 0.2% carbomer, 3% ethylene glycol, 0.8% sodium alginate, 0.08% disodium edetate, 0.35% triethanolamine, 2% hexanediol, 0.15% p-hydroxyacetophenone, 0.75% squalene, 5% ginger flower root extract, 2% *Ipomoea aquatica* extract, 0.85% *Cyperus rotundus* lysate extract, 0.4% aescin, 4% lutein ester, 2.5% zeaxanthin, 0.85% B vitamins, 1.75% sodium hyaluronate, and the balance being deionized water. The B vitamins consist of vitamin B1, vitamin B6, and vitamin B12 in a weight ratio of 2:1:1.

[0032] 2. Preparation of core components The preparation methods for ginger flower root extract, rice straw extract, and Cyperus rotundus lysate extract are the same as in Example 1.

[0033] 3. The eye-protecting compositions of Examples 1-3 described above were used to prepare eye patches according to the following method: S1. Preparation of the composition: S11. Take deionized water, stir at 40℃ and 400rpm, add carbomer and sodium alginate, and continue stirring for 2 hours until completely dissolved to form a gel matrix. S12. Add glycerol, ethylene glycol, hexanediol and disodium edetate to the gel matrix in sequence, stir for 35 min, then add triethanolamine dropwise to adjust the pH of the system to 6.5, and stir for 12 min. S13. Cool to 30℃, add p-hydroxyacetophenone, stir for 25 minutes to dissolve, then add squalene, ginger root extract powder, rice straw extract powder, lysate extract powder, aesculin, lutein ester, zeaxanthin, B vitamins and sodium hyaluronate in sequence, and ultrasonically disperse at 200W for 50 minutes to obtain the eye protection composition. S2, Solution carrier layer impregnation: Immerse the breathable membrane in the eye protection composition prepared in step S1 and impregnate at 28°C for 25 minutes to form a solution carrier layer; S3, Lamination and Composite: Nonwoven fabric, solution carrier layer and isolation layer are sequentially laminated under a pressure of 0.1-0.3MPa and a temperature of 32℃ to obtain composite substrate; S4. Molding: The composite substrate obtained in step S3 is cut and shaped to obtain the eye patch.

[0034] The aforementioned isolation layer is a polyethylene film with a thickness of 30 μm; the breathable membrane is a medical-grade breathable membrane with a thickness of 0.1 mm and a solution loading of 1.35 g / cm³. 2 The measured air permeability was 400±1.2 g / (m³). 2 •24h).

[0035] Comparative Example 1 The difference between this comparative example and Example 3 is that the eye-protecting composition does not contain squalene, ginger root extract, rice bran extract, cyperus rotundus lysate extract, aesculin, and lutein esters; the missing components are supplemented by deionized water.

[0036] Comparative Example 2 The difference between this comparative example and Example 3 is that the eye-protecting composition does not contain squalene, ginger flower root extract, or rice bran extract, and the missing components are made up with deionized water.

[0037] Comparative Example 3 The difference between this comparative example and Example 3 is that the eye protection composition does not contain Cyperus rotundus lysate extract, aescin, or lutein ester, and the missing components are made up by deionized water.

[0038] Comparative Example 4 The difference between this comparative example and Example 3 is that the eye protection composition does not contain the extract of Cyperus rotundus lysate, and the missing component is made up by deionized water.

[0039] I. Animal Model Efficacy Experiment 1. A model for relieving dry eye syndrome 1.1 Laboratory Animals and Grouping: Animals: Healthy New Zealand white rabbits, weighing 2.0-2.5 kg, with no eye diseases. Six rabbits per group, with one eye used for experimentation.

[0040] Grouping: Normal control group: No modeling or intervention.

[0041] Model control group: Model established, no treatment given.

[0042] Positive control group: Model established, daily use of commercially available sodium hyaluronate eye drops.

[0043] Examples 1-3: Modeling was performed, and the eye patches prepared in Examples 1-3 were applied daily.

[0044] Comparative Examples 1-4: Models were created, and the eye patches prepared in Comparative Examples 1-4 were applied daily.

[0045] 1.2 Experimental Methods Dry eye model establishment: Except for the normal control group, the experimental eyes of the other groups were instilled with 0.1% benzalkonium chloride solution twice a day, 10 μL each time, for 14 consecutive days to induce dry eye.

[0046] Intervention: Starting from day 8, one hour after the addition of benzalkonium chloride drops, each intervention group received the corresponding treatment for 7 days. The patch group had eye patches cut to an appropriate size and applied to the outside of the eyelids for 2 hours each time, once a day.

[0047] BUT Measurements: Measurements were performed by professionals under a slit-lamp microscope before intervention (day 7) and at the end of intervention (day 14). One drop of 1% sodium fluorescein was instilled into the lower fornix of the rabbit's eye, inducing several blinks. Under cobalt blue light, the time from the last complete blink to the appearance of the first randomly distributed black spot on the cornea (tear film rupture) was recorded using a stopwatch. The average of three measurements was taken.

[0048] 1.3 Test Results: Table 1: Effects of each intervention group on tear film breakup time in dry eye model rabbits (s, Mean±SD, n=6)

[0049] Results analysis: As shown in Table 1, the BUT extension value after intervention in the positive control group was 5.9 seconds, confirming the effectiveness of the basic treatment. After intervention in Examples 1-3, the BUT was all above 10.5 seconds, with an extension value of 6.3-6.6 seconds, significantly better than the positive control group. Example 3 showed the best effect, with an extension of 6.6 seconds, indicating that the dry eye relief efficacy of the formula of this invention is superior, and the synergistic ratio of the core components further enhances the effect. After intervention in Comparative Examples 1-4, the BUT extension values ​​were all lower than those in the Example groups, with Comparative Example 3 having an extension value of only 2.2 seconds, and Comparative Examples 2 and 4 having extension values ​​of 3.7 seconds and 4.2 seconds, respectively. This indicates that the dry eye relief effect is significantly reduced after the absence of the core active component or the change in the synergistic ratio.

[0050] 2. Determination of contractility of isolated ciliary muscle 2.1 Experimental Materials and Grouping Source of tissue: Healthy New Zealand white rabbits (weighing 2.0-2.5kg), male or female, the ciliary muscle was quickly separated and made into a muscle strip of about 2×5mm.

[0051] Reagents: Krebs-Henseleit nutrient solution (composition: NaCl 118 mmol / L, KCl 4.7 mmol / L, CaCl2 2.5 mmol / L, MgSO4 1.2 mmol / L, NaHCO3 25 mmol / L, KH2PO4 1.2 mmol / L, glucose 11 mmol / L, pH 7.3-7.4), acetylcholine (ACh, purity ≥98%) Grouping: Six ciliary muscle strips from different rabbits were randomly assigned to each experimental group.

[0052] Blank control group: Krebs solution treatment, without the addition of any extraction solution.

[0053] ACh model group: stimulated with ACh only.

[0054] Example 3 group: Pretreated with the extract of the eye patch from Example 3.

[0055] Comparative Example 1: Pretreated with the extract from the eye patch of Comparative Example 1.

[0056] Comparative Example 2: Pretreated with the extract from the eye patch of Comparative Example 2.

[0057] Comparative Example 3: Pretreated with the extract from the eye patch of Comparative Example 3.

[0058] Comparative Example 4: Pretreated with the extract from the eye patch of Comparative Example 4.

[0059] Preparation of extract: 1 cm 2 Each eye patch solution carrier layer of a certain size was immersed in 10 ml of Krebs solution, shaken to extract, filtered and sterilized to prepare medicated Krebs solution.

[0060] 2.2 Experimental Methods Instrument: Multichannel ex vivo tissue and organ bath system.

[0061] Muscle strip suspension: The two ends of the ciliary muscle strip are tied together, with one end fixed to the bottom of the bath and the other end connected to a tension sensor. The bath is filled with Krebs solution at 37°C, continuously circulated with 95% O2 / 5% CO2.

[0062] Equilibration: Introduce 1.0g of initial resting tension, equilibrate for 60 minutes, and change the nutrient solution every 15 minutes.

[0063] Pre-contraction and sensitivity test: Stimulation with 60 mL M KCl solution was used to confirm muscle strip activity. After rinsing and recovery, the ACh concentration that caused the maximum contraction (Emax) was recorded.

[0064] Efficacy test: The muscle strips were randomly assigned to each pretreatment group. The solution was then replaced with Krebs solution containing the corresponding eye patch extract, and incubated for 30 minutes.

[0065] After incubation, without changing the liquid, directly add the solution to a final concentration of 10. -4 M's ACh stimulates muscle strip contraction. Changes in muscle strip tension are recorded, and the maximum amplitude of contraction is measured.

[0066] Inhibition rate (%) = [1 - (maximum contraction amplitude of pretreatment group / maximum contraction amplitude of ACh model group)] × 100%; 3. Test Results Table 2: Inhibitory effect of eye patch extracts on ACh-induced contraction of isolated rabbit ciliary muscle

[0067] As shown in Table 2, the test results of Example 3 showed that the inhibition rate of acetylcholine (ACh)-induced isolated rabbit ciliary muscle contraction reached 58.0%. This inhibitory effect was significantly better than that of the other control groups, indicating that the seven core components contained in Example 3 form a synergistic system that can effectively inhibit ACh-induced ciliary muscle contraction, thereby demonstrating the best effect in relieving eye fatigue.

[0068] The inhibition rate of Comparative Example 1 was only 5.0%, and its formula lacked 6 core active ingredients, resulting in almost no inhibitory effect on ciliary muscle contraction. This confirms that the above-mentioned core components are the key to the eye patch of this invention's effect of relieving eye fatigue.

[0069] The inhibition rate of Comparative Example 2 was 39.0% and that of Comparative Example 3 was 35.0%. Both examples showed a significantly lower inhibition rate than Example 3 due to the absence of different core component combinations, which fully demonstrates the necessity of the synergistic effect between core components.

[0070] The inhibition rate of Comparative Example 4 was 50.0%, which was only lower than that of Example 3, indicating that the extract of *Acinetobacter lysate* and other ingredients in the formulation work together to form a complementary and synergistic system.

[0071] The excellent inhibitory effect achieved in Example 3 is the result of the combined action of this complete system, and its efficacy is significantly better than that of a single type of component or an incomplete combination of components.

[0072] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An eye patch for relieving dry eyes, visual fatigue, and myopia, characterized in that, From the outside to the inside, it includes an isolation layer, a solution carrier layer, and a nonwoven fabric; the solution carrier layer is a breathable membrane impregnated with an eye-protecting composition; the eye-protecting composition includes the following components in weight percentage: glycerin 5-8%, carbomer 0.1-0.3%, ethylene glycol 2-4%, sodium alginate 0.5-1.2%, disodium edetate 0.05-0.1%, triethanolamine 0.2-0.5%, hexanediol 1-3%, and p-hydroxyacetophenone 0.1-0.2%.

2. The eye patch as described in claim 1, characterized in that, The isolation layer is made of polyethylene film with a thickness of 20-50 μm; the breathable membrane is a medical breathable membrane with a thickness of 0.08-0.12 mm and a solution loading of 1.2-1.5 g / cm³. 2 .

3. The eye patch as described in claim 1, characterized in that, The eye-protecting composition further comprises the following components in weight percentage: squalene 0.3-1.2%, ginger flower root extract 2-8%, rice bran extract 1-3%, cyperus rotundus lysate extract 0.5-1.2%, aesculin 0.05-0.8%, lutein ester 2-6%, zeaxanthin 1-4%, B vitamins 0.2-1.5%, and sodium hyaluronate 0.5-3.0%.

4. The eye patch as described in claim 3, characterized in that, The preparation method of the *Cyperus bisporus* lysate extract includes the following steps: (1) Cell culture: Take the bacteria for culture to obtain fermentation broth, centrifuge the fermentation broth and collect the cell precipitate; (2) Compound cell disruption: The bacterial cells are resuspended in cell disruption buffer to obtain a bacterial suspension, and then a compound enzyme is added for enzymatic hydrolysis; (3) Disruption and extraction: The bacterial suspension after enzymatic hydrolysis is subjected to intermittent ultrasonic treatment to obtain the bacterial cell disruption liquid; (4) Separation and purification: The bacterial cell lysate is subjected to solid-liquid separation, the liquid portion containing soluble active ingredients is collected, and then purified and concentrated to obtain the bacterial cell lysate extract.

5. The eye patch as described in claim 4, characterized in that, The culture conditions described in step (1) are: 25-30℃, pH 6.5-7.5, and shaking culture for 48-72 hours; the centrifugation conditions are: 4℃, 8000-12000rpm, and centrifugation for 15-20 minutes. The cell disruption buffer in step (2) is a phosphate buffer with a pH of 5.5-6.5 and a concentration of 0.02-0.05M; the ratio of the bacterial cells to the cell disruption buffer in g / mL is 1:5-15; the enzymatic hydrolysis temperature is 35-40℃, the pH is 5.5-6.5, and the duration is 2-4 hours. The ultrasonic power in step (3) is 300-500W, with a working time of 2 seconds and an interval of 3 seconds, for a total time of 10-15 minutes; The solid-liquid separation in step (4) is carried out by ultracentrifugation at 3-5℃ and 12000-18000rpm for 25-35 minutes, collecting the supernatant and filtering it through a 0.22μm filter membrane for sterilization. The concentration is carried out by ultrafiltration concentration using an ultrafiltration membrane with a molecular weight cutoff of 3kDa.

6. The eye patch as described in claim 5, characterized in that, The compound enzyme in step (2) is lysozyme and snail enzyme in a mass ratio of 1:0.8-1.2, and the amount of enzyme added is 0.5-1.0% of the mass of the bacterial suspension.

7. The eye patch as described in claim 1, characterized in that, The B vitamins are composed of vitamin B1, vitamin B6, and vitamin B12 in a weight ratio of 2:1:

1.

8. The method for preparing the eye patch according to any one of claims 1-7, characterized in that, Includes the following steps: S1. Composition preparation: Mix each component with a pharmaceutically acceptable solvent to prepare an eye-protecting composition; S2, Solution carrier layer impregnation: Immerse the breathable membrane in the eye protection composition prepared in step S1, and impregnate it at a temperature of 25-30℃ for 20-30 minutes to form a solution carrier layer; S3, Lamination and Composite: Non-woven fabric, solution carrier layer and isolation layer are sequentially laminated under a pressure of 0.1-0.3MPa and a temperature of 30-35℃ to obtain composite substrate; S4. Molding: The composite substrate obtained in step S3 is cut and shaped to obtain the eye patch.

9. The method for preparing the eye patch as described in claim 8, characterized in that, The composition is formulated by: S11. Take a pharmaceutically acceptable solvent, stir at 35-45℃ and 300-500 rpm, add carbomer and sodium alginate, and continue stirring for 1.5-2.5 hours until completely dissolved to form a gel matrix; S12. Add glycerol, ethylene glycol, hexanediol and disodium edetate to the gel matrix in sequence, stir for 30-40 min, then add triethanolamine dropwise to adjust the pH of the system to 6.0-7.0, and stir for 10-15 min. S13. Cool to 30-34℃, add p-hydroxyacetophenone, stir for 20-30 minutes to dissolve, then add squalene, ginger root extract powder, rice straw extract powder, cyperus rotundus lysate extract powder, aesculin, lutein ester, zeaxanthin, B vitamins and sodium hyaluronate in sequence, and ultrasonically disperse at 150-250W for 40-60 minutes to obtain the eye protection composition.

10. The use of the eye patch according to any one of claims 1-7 in the preparation of products for relieving dry eyes, visual fatigue and myopia.

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