Eye protection liquid and preparation method thereof

Abstract

The invention discloses eye protection liquid and a preparation method thereof, and relates to the technical field of eye protection liquid, and the eye protection liquid is prepared from the following components in percentage by mass: 1.0%-5.0% of golden emperor chrysanthemum hydrolat, 0.05%-0.5% of golden emperor chrysanthemum extracting solution, 1.0%-5.0% of butterflybush flower hydrolat, 0.05%-0.5% of butterflybush flower extracting solution, 0.05%-1.0% of green tea extracting solution, 0.5%-1.0% of sodium chloride, 0.1%-2.0% of buffer pair and the balance of ultrapure water. The preparation method comprises the following steps: preparing golden chrysanthemum hydrolat and extracting solution, butterflybush flower hydrolat and extracting solution and green tea extracting solution; dissolving the buffer pair and sodium chloride in ultrapure water to obtain a buffer solution; adding the golden imperial chrysanthemum hydrolat and extracting solution, the butterflybush flower hydrolat and extracting solution and the green tea extracting solution into the buffer solution, and uniformly mixing; measuring and adjusting the osmotic pressure and the pH value of the solution; and filtering, sterilizing and packaging. The eye protection liquid provided by the invention can be used for nourishing eyes in an atomization manner, is mild in components, has a relatively lasting soothing effect on the eyes, and can be used for effectively relieving eye fatigue.

Description

Technical Field

[0001] The present invention relates to the technical field of eye drops, and in particular to an eye drop and a preparation method thereof. Background Art

[0002] With modern people using electronic devices for a long time, eye problems such as eye fatigue, dryness, and bloodshot eyes have become increasingly prominent. Especially the "digital eye fatigue syndrome" has become a health problem widely concerned globally. Such symptoms usually manifest as eye dryness, pain, blurred vision, headache, etc., and may seriously affect daily work and life when severe.

[0003] In order to relieve eye fatigue, there are already various eye drop products on the market. The main functions of these products are to clean the eyes, soothe eye discomfort, relieve eye dryness, etc. However, the existing eye drop products still have some deficiencies in terms of usage experience, ingredient effectiveness, absorption rate, and duration of action, such as the non-persistent soothing effect, irritation problems, etc. Summary of the Invention

[0004] In order to solve the above technical problems, the present invention provides an eye drop and a preparation method thereof. The specific technical solution is as follows:

[0005] An eye drop is made from the following components: by mass percentage, 1.0% - 5.0% of pure chrysanthemum morifolium ramat. dew, 0.05% - 0.5% of chrysanthemum morifolium ramat. extract, 1.0% - 5.0% of buddleja officinalis maxim. pure dew, 0.05% - 0.5% of buddleja officinalis maxim. extract, 0.05% - 1.0% of green tea extract, 0.5% - 1.0% of sodium chloride, 0.1% - 2.0% of buffer pair, and the balance is ultrapure water.

[0006] Further, in the components: 3% of pure chrysanthemum morifolium ramat. dew, 0.2% of chrysanthemum morifolium ramat. extract, 3% of buddleja officinalis maxim. pure dew, 0.2% of buddleja officinalis maxim. extract, 0.5% of green tea extract, 1.6% of buffer pair, 0.9% of sodium chloride.

[0007] The present invention also provides a preparation method for preparing the eye drop as described in any one of the above, including the following steps:

[0008] Step a: Preparation of pure chrysanthemum morifolium ramat. dew and extract, buddleja officinalis maxim. pure dew and extract, and green tea extract;

[0009] Step b: Dissolve the buffer pair and sodium chloride in ultrapure water to obtain a buffer solution;

[0010] Step c: Add the pure chrysanthemum morifolium ramat. dew and extract, buddleja officinalis maxim. pure dew and extract, and green tea extract into the buffer solution and mix evenly;

[0011] Step d: Measure and adjust the osmotic pressure and pH value of the solution;

[0012] Step e: Filtration, sterilization, and packaging.

[0013] Furthermore:

[0014] The pure dew and extract of Chrysanthemum morifolium Ramat. cv. Jinhuangju and the pure dew and extract of Buddleja officinalis Maxim. are prepared by a method of first distillation extraction and then solvent extraction;

[0015] The green tea extract is prepared by a solvent extraction method.

[0016] Furthermore:

[0017] The method of first distillation extraction and then solvent extraction specifically includes: crushing the dried Chrysanthemum morifolium Ramat. cv. Jinhuangju or Buddleja officinalis Maxim., soaking the crushed raw material with purified water at a material-liquid ratio of 1:15 to obtain a first leaching solution, heating and distilling the first leaching solution for 2 h, and collecting the cooled liquid through a condenser to obtain the pure dew of Chrysanthemum morifolium Ramat. cv. Jinhuangju / Buddleja officinalis Maxim.; filtering the first leaching solution and then concentrating it under reduced pressure to obtain the extract of Chrysanthemum morifolium Ramat. cv. Jinhuangju / Buddleja officinalis Maxim.;

[0018] The solvent extraction method specifically includes: crushing the dried green tea, soaking the crushed raw material with purified water at a material-liquid ratio of 1:10 to obtain a second leaching solution, heating and refluxing the second leaching solution for 30 min, filtering it, and concentrating it under reduced pressure to obtain the green tea extract.

[0019] Furthermore:

[0020] The heating and distillation temperature of the first leaching solution is 40 - 60 °C;

[0021] The heating and reflux temperature of the second leaching solution is 60 - 80 °C.

[0022] Furthermore, the pH of the solution in step d is 6.8 - 7.5.

[0023] Furthermore, an ultrasonic device is used for continuous ultrasonic treatment during the heating and distillation process of the first leaching solution and the heating and reflux process of the second leaching solution.

[0024] Furthermore, filtration and sterilization are carried out by ultrafiltration technology in step e.

[0025] Furthermore, step c specifically includes the following sub-steps:

[0026] Step c1: Mix and disperse the pure dew of Chrysanthemum morifolium Ramat. cv. Jinhuangju, the pure dew of Buddleja officinalis Maxim., and PLGA evenly;

[0027] Step c2: Mix Tween 80 and Span 80 to form a surfactant component solution;

[0028] Step c3: Add the mixture obtained in step c1 into the surfactant component solution, and use a high-shear homogenizer or an ultrasonic device to emulsify the mixed solution to form a nano-emulsion;

[0029] Step c4: Add the Chrysanthemum morifolium Ramat. extract, Buddleja officinalis Maxim. extract, and green tea extract into ultrapure water, and stir and disperse evenly to obtain a mixed solution;

[0030] Step c5: Mix the nano-emulsion obtained in step c3 and the mixed solution obtained in step c4 and disperse evenly.

[0031] Preferably, the PLGA in step c1 is a modified PLGA mixed component, and the modified PLGA mixed component includes: by mass percentage, 40% - 50% of chitosan copolymerized PLGA, 25% - 35% of aminated PLGA, and 20% - 30% of carboxylated PLGA.

[0032] Preferably, the preparation of the chitosan copolymerized PLGA includes the following steps:

[0033] Dissolve PLGA in a mixed solution of ethanol and water to make a first solution with a concentration of 5% - 10%;

[0034] Dissolve chitosan in an acetic acid solution or water, and heat to 40 - 50 °C to obtain a chitosan solution;

[0035] Slowly add the chitosan solution into the first solution, and use magnetic stirring or high-speed stirring to mix evenly;

[0036] Under the condition of 0 - 5 °C, add an epoxide for copolymerization reaction;

[0037] After stirring and reacting for 24 h, remove the unreacted solvent and cross-linking agent by the solvent exchange method;

[0038] Obtain it after removing the solvent by freeze-drying or vacuum drying.

[0039] Preferably, the preparation of the aminated PLGA includes the following steps:

[0040] Dissolve PLGA in a mixed solution of ethanol and water to make a second solution with a concentration of 5% - 10%;

[0041] Add glycine or triethanolamine to the second solution and stir at room temperature for 6 - 12 h;

[0042] Wash the modified PLGA with water to remove the residual reagents, and obtain it after removing the solvent by freeze-drying or vacuum drying.

[0043] Preferably, the preparation of the carboxylated PLGA includes the following steps:

[0044] Dissolve PLGA in a mixed solution of ethanol and water to prepare a third solution with a concentration of 5% to 10%.

[0045] Add succinic acid to the third solution and react at 60 - 80 °C for 4 - 6 hours.

[0046] Wash the modified PLGA with water to remove residual reagents, and then remove the solvent by freeze-drying or vacuum drying to obtain the product.

[0047] Preferably, the Tween 80 and Span 80 in step c2 are surfactants after surface modification by graft copolymerization. The graft copolymerization method includes the following steps:

[0048] Weigh Tween 80 or Span 80 and dissolve it in absolute ethanol to obtain a surfactant solution with a concentration of 5 - 10 wt%.

[0049] Dissolve dimethyldiallylammonium chloride in absolute ethanol to prepare a first monomer solution with a concentration of 5 - 10 wt%.

[0050] Dissolve polyvinyl alcohol or polyvinylpyrrolidone in water to prepare a second monomer solution with a concentration of 5 - 10 wt%.

[0051] Mix the first and second monomer solutions in a molar ratio of 1:2 and add them to the surfactant solution, then stir evenly.

[0052] Heat to 60 - 70 °C, add hydrogen peroxide to initiate a free radical polymerization reaction, control the reaction temperature at 60 - 70 °C, and the reaction time is 2 - 4 h, where the dosage of hydrogen peroxide is 1 - 2 wt%.

[0053] After the reaction, add a neutralizing agent to adjust the pH of the reaction solution to 6.8 - 7.5.

[0054] Use aqueous extraction to remove the solvent, unreacted monomers, and impurities in the reaction solution, and remove the residual solvent by evaporation.

[0055] Purify the product by centrifugation or gel permeation chromatography and remove low molecular weight impurities to obtain the product.

[0056] The eye care solution provided by the present invention nourishes the eyes by atomization, has mild components, a relatively long-lasting soothing effect on the eyes, and can effectively relieve eye fatigue. Detailed implementation mode

[0057] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be described in detail below. The description of this part is only exemplary and explanatory, and should not have any restrictive effect on the protection scope of the present invention.

[0058] This embodiment provides an eye care solution, which is made from the following components: by mass percentage, 1.0% - 5.0% of pure chrysanthemum morifolium ramat. dew, 0.05% - 0.5% of chrysanthemum morifolium ramat. extract, 1.0% - 5.0% of buddleja officinalis maxim. pure dew, 0.05% - 0.5% of buddleja officinalis maxim. extract, 0.05% - 1.0% of green tea extract, 0.5% - 1.0% of sodium chloride, 0.1% - 2.0% of buffer pair, and the balance is ultrapure water.

[0059] Among them, each component and its function are as follows: Pure chrysanthemum morifolium ramat. dew and buddleja officinalis maxim. pure dew are the main active ingredients, which have soothing and anti-inflammatory effects and help with the sedation and moisturization of the eyes. Green tea extract is rich in tea polyphenols, which have antioxidant and anti-inflammatory effects and help protect the eyes from free radical damage. Chrysanthemum morifolium ramat. extract and buddleja officinalis maxim. extract further enhance the soothing and repair effects. The buffer pair is used to adjust the pH value of the liquid to be close to the natural pH value of the eyes to avoid irritation. Sodium chloride is used to adjust the osmotic pressure so that the osmotic pressure of the eye care solution in the eyes is similar to that of the eye fluid to avoid discomfort.

[0060] The eye care solution provided by this embodiment nourishes the eyes through atomization, has mild ingredients, a relatively long-lasting soothing effect on the eyes, and can effectively relieve eye fatigue.

[0061] Furthermore, in the components: 3% of pure chrysanthemum morifolium ramat. dew, 0.2% of chrysanthemum morifolium ramat. extract, 3% of buddleja officinalis maxim. pure dew, 0.2% of buddleja officinalis maxim. extract, 0.5% of green tea extract, 1.6% of buffer pair, and 0.9% of sodium chloride.

[0062] This embodiment also provides a preparation method for preparing the eye care solution as described in any one of the above, including the following steps:

[0063] Step a: Preparation of pure chrysanthemum morifolium ramat. dew and extract, buddleja officinalis maxim. pure dew and extract, and green tea extract.

[0064] Step b: Dissolve the buffer pair and sodium chloride in ultrapure water to obtain a buffer solution.

[0065] Step c: Add pure chrysanthemum morifolium ramat. dew and extract, buddleja officinalis maxim. pure dew and extract, and green tea extract to the buffer solution and mix evenly.

[0066] Step d: Measure and adjust the osmotic pressure and pH value of the solution.

[0067] Step e: Filter, sterilize and package.

[0068] Furthermore:

[0069] Pure chrysanthemum morifolium ramat. dew and extract, and buddleja officinalis maxim. pure dew and extract are prepared by a method of first distillation extraction and then solvent extraction.

[0070] The green tea extract is prepared by the solvent extraction method.

[0071] Furthermore:

[0072] The method of first distillation extraction and then solvent extraction specifically includes: crushing the dried Chrysanthemum morifolium Ramat. cv. Jinhuangju or Buddleja officinalis Maxim., soaking the crushed raw material with purified water at a material-liquid ratio of 1:15 to obtain the first leaching solution, heating and distilling the first leaching solution for 2 h, and collecting the cooled liquid through a condenser to obtain the Chrysanthemum morifolium Ramat. cv. Jinhuangju / Buddleja officinalis Maxim. hydrosol. Filter the first leaching solution and then concentrate it under reduced pressure to obtain the Chrysanthemum morifolium Ramat. cv. Jinhuangju / Buddleja officinalis Maxim. extract.

[0073] The solvent extraction method specifically includes: crushing the dried green tea, soaking the crushed raw material with purified water at a material-liquid ratio of 1:10 to obtain the second leaching solution, heating and refluxing the second leaching solution for 30 min, filtering it, and then concentrating it under reduced pressure to obtain the green tea extract.

[0074] Furthermore:

[0075] The heating and distillation temperature of the first leaching solution is 40 - 60 °C.

[0076] The heating and reflux temperature of the second leaching solution is 60 - 80 °C.

[0077] Furthermore, the pH of the solution in step d is 6.8 - 7.5.

[0078] Furthermore, during the heating and distillation process of the first leaching solution and the heating and reflux process of the second leaching solution, an ultrasonic device is used for continuous ultrasonic treatment.

[0079] Furthermore, in step e, filtration and sterilization are carried out through ultrafiltration technology.

[0080] Furthermore, step c specifically includes the following sub-steps:

[0081] Step c1: Mix and disperse the Chrysanthemum morifolium Ramat. cv. Jinhuangju hydrosol, Buddleja officinalis Maxim. hydrosol and PLGA evenly.

[0082] Step c2: Mix Tween 80 and Span 80 to form the surfactant component liquid.

[0083] Step c3: Add the mixture obtained in step c1 into the surfactant component liquid, and use a high-shear homogenizer or an ultrasonic device to emulsify the mixed liquid to form a nano-scale emulsion.

[0084] Step c4: Add the Chrysanthemum morifolium Ramat. cv. Jinhuangju extract, Buddleja officinalis Maxim. extract and green tea extract into ultrapure water, stir and disperse evenly to obtain a mixed solution.

[0085] Step c5: Mix and disperse evenly the nano-scale emulsion obtained in step c3 and the mixed solution obtained in step c4.

[0086] Further, in step c1, the PLGA is a modified PLGA mixed component, and the modified PLGA mixed component includes: by mass percentage, 40% - 50% of chitosan copolymerized PLGA, 25% - 35% of aminated PLGA, and 20% - 30% of carboxylated PLGA.

[0087] Among them, chitosan copolymerized PLGA has the following beneficial effects: through the regulation of the copolymer, PLGA exhibits more emulsification characteristics, improving the stability of the emulsion; the modified PLGA has better biodegradability and biocompatibility, suitable for long-term eye use.

[0088] Aminated PLGA and carboxylated PLGA have the following beneficial effects: by introducing hydrophilic functional groups into the PLGA molecule to adjust the surface properties of PLGA, enabling PLGA to better load drug components (extracts of Chrysanthemum morifolium Ramat. and Buddleja officinalis Maxim.), and improving its emulsification performance in the aqueous phase.

[0089] Further, in the said components, 45% of chitosan copolymerized PLGA, 30% of aminated PLGA, and 25% of carboxylated PLGA can optimize the stability, biocompatibility, drug loading and release effects of the nano eye care solution. This ratio can improve the emulsion stability while ensuring the safety and effectiveness of the eye care product, meeting the needs of eye care.

[0090] Further, the preparation of chitosan copolymerized PLGA includes the following steps:

[0091] Dissolve PLGA in a mixed solution of ethanol and water (where the ethanol concentration is controlled between 10% and 40%) to make a first solution with a concentration of 5% - 10%;

[0092] Dissolve chitosan in acetic acid solution or water, and heat it to 40 - 50 °C to obtain a chitosan solution;

[0093] Slowly add the chitosan solution to the first solution, and mix evenly using magnetic stirring or high-speed stirring;

[0094] Under the condition of 0 - 5 °C, add an epoxide for copolymerization reaction;

[0095] After stirring and reacting for 24 h, remove the unreacted solvent and cross-linking agent by solvent exchange method;

[0096] Obtain it by removing the solvent through freeze-drying or vacuum drying.

[0097] Further, the preparation of aminated PLGA includes the following steps:

[0098] Dissolve PLGA in a mixed solution of ethanol and water to prepare a second solution with a concentration of 5% - 10%.

[0099] Add glycine or triethanolamine to the second solution and stir at room temperature for 6 - 12 h.

[0100] Wash the modified PLGA with water to remove residual reagents, and then remove the solvent by freeze - drying or vacuum drying to obtain the product.

[0101] Furthermore, the preparation of carboxylated PLGA includes the following steps:

[0102] Dissolve PLGA in a mixed solution of ethanol and water to prepare a third solution with a concentration of 5% - 10%.

[0103] Add succinic acid to the third solution and react at 60 - 80 °C for 4 - 6 hours.

[0104] Wash the modified PLGA with water to remove residual reagents, and then remove the solvent by freeze - drying or vacuum drying to obtain the product.

[0105] Furthermore, in step c2, Tween 80 and Span 80 are surfactants after surface modification by graft copolymerization. The graft copolymerization method includes the following steps:

[0106] Weigh Tween 80 or Span 80 and dissolve it in absolute ethanol to obtain a surfactant solution with a concentration of 5 - 10 wt%.

[0107] Dissolve dimethyldiallylammonium chloride in absolute ethanol to prepare a first monomer solution with a concentration of 5 - 10 wt%.

[0108] Dissolve polyvinyl alcohol or polyvinylpyrrolidone in water to prepare a second monomer solution with a concentration of 5 - 10 wt%.

[0109] Mix the first and second monomer solutions in a molar ratio of 1:2 and add them to the surfactant solution, then stir evenly.

[0110] Heat to 60 - 70 °C, add hydrogen peroxide to initiate a free - radical polymerization reaction, control the reaction temperature at 60 - 70 °C, and the reaction time is 2 - 4 h, where the dosage of hydrogen peroxide is 1 - 2 wt%.

[0111] After the reaction, add a neutralizing agent to adjust the pH of the reaction solution to 6.8 - 7.5.

[0112] Use aqueous extraction to remove the solvent, unreacted monomers, and impurities in the reaction solution, and then remove the residual solvent by evaporation.

[0113] The product is obtained by purifying through centrifugation or gel permeation chromatography and removing low molecular weight impurities.

[0114] Among them, the surface modification of Tween 80 and Span 80 has the following beneficial effects:

[0115] 1. Mildness and low irritation: By selecting a suitable amphoteric surfactant, the eye wash can have good mildness when used on the eyes, reducing irritation to the eyes.

[0116] 2. Charge regulation: The modified surfactant can regulate the charge in different pH environments, adapt to the physiological environment of the eyes, and enhance the compatibility with eye tissues.

[0117] 3. Stability and long-term preservation: The modified formulation has good stability and will not show stratification or precipitation, making it suitable for long-term preservation.

[0118] 4. Biocompatibility: The modified surfactant has passed cytotoxicity and irritation tests to ensure its harmlessness to the eyes and compliance with safety standards.

[0119] Specific examples are provided below. The provided examples can enable those skilled in the art to understand the present invention more comprehensively, but do not limit the present invention in any way.

[0120] Example 1: Preparation of eye care liquid

[0121] Raw materials:

[0122] Pure dew of Chrysanthemum morifolium Ramat. cv. Jinhuangju: 3% (30 mL)

[0123] Pure dew of Buddleja officinalis Maxim.: 3% (30 mL)

[0124] Green tea extract (concentrate, 10%): 0.5% (5 mL)

[0125] Extract of Chrysanthemum morifolium Ramat. cv. Jinhuangju (10:1 concentrate): 0.2% (2 mL)

[0126] Extract of Buddleja officinalis Maxim. (10:1 concentrate): 0.2% (2 mL)

[0127] Buffer pair (75% disodium hydrogen phosphate, 25% potassium dihydrogen phosphate): 1.6% (16 g)

[0128] Sodium chloride: 0.9% (9 g)

[0129] Ultra-pure water: Added to 100% (added to 1000 mL)

[0130] Equipment:

[0131] Sterile stirrer

[0132] Magnetic stirrer / homogenizer

[0133] 0.22μm sterile filter membrane

[0134] Filling machine (aseptic filling)

[0135] Glass bottle / plastic bottle (aseptic bottle)

[0136] Process steps:

[0137] Under aseptic conditions, take an appropriate amount of ultrapure water (about 500 mL), add buffer pair (16 g) and sodium chloride (9 g), and dissolve with stirring to obtain a buffer solution. Check the pH value of the buffer solution with a pH meter to ensure that the pH value is 7.4.

[0138] Add pure extract of Chrysanthemum morifolium Ramat. (30 mL) and pure extract of Buddleja officinalis Maxim. (30 mL) to the buffer solution respectively and stir evenly.

[0139] Add green tea extract (5 mL, 10% concentrated solution), Chrysanthemum morifolium Ramat. extract (2 mL, 10:1 concentrated solution), and Buddleja officinalis Maxim. extract (2 mL, 10:1 concentrated solution) to the above mixture, and continue to stir to ensure that all components are completely dissolved and evenly dispersed.

[0140] Filter the mixed solution with a 0.22μm sterile filter membrane to remove particulate impurities and ensure that the solution is clear and sterile.

[0141] Check the osmotic pressure of the solution with a freezing point osmometer to ensure that the osmotic pressure of the solution is 0.9% NaCl (the osmotic pressure of normal eye fluid).

[0142] After the sterilized eye drops are cooled, use an aseptic filling device to fill the solution into aseptic glass bottles or plastic bottles.

[0143] During the filling process, filter again through a 0.22μm sterile filter membrane to ensure that the filled liquid is sterile and free of particles.

[0144] Example 2: Long-term stability of eye drops

[0145] In order to verify the stability of the eye drops during long-term storage, an accelerated stability test was carried out in Example 2. The specific operations are as follows:

[0146] Sample preparation: Place 100 mL of atomized eye drop sample in a transparent glass bottle and label the batch number.

[0147] Storage conditions:

[0148] Normal temperature: Store under normal temperature conditions of 25°C ± 2°C.

[0149] High temperature: Store in an environment of 40°C ± 2°C to simulate the high-temperature storage conditions of the product.

[0150] Stability test:

[0151] Appearance: Observe the color, transparency, and presence of precipitates of the eye drops.

[0152] pH value: Regularly check the pH value of the eye drops to confirm whether it changes.

[0153] Osmotic pressure: Check whether the osmotic pressure remains near 0.9% NaCl.

[0154] Microbial detection: Conduct microbial detection on the samples every 3 months to confirm sterility.

[0155] Test time: The test time is 6 months.

[0156] Test results:

[0157] Under normal and high-temperature conditions, after 6 months of testing, no obvious changes occurred in the product. The appearance remained transparent, without precipitation, the pH value was stable at 7.4, the osmotic pressure remained at 0.9% NaCl, and no microbial contamination was detected.

[0158] This indicates that the formulation has good stability under normal storage conditions and is suitable for long-term use.

[0159] Example 3: Effect of the eye drops in relieving eye fatigue

[0160] Experimental method:

[0161] Experimental subjects: 30 healthy volunteers (15 males and 15 females), aged between 20 and 40 years old, and all had symptoms of frequent eye fatigue (such as dry eyes, blurriness, fatigue, etc.).

[0162] Experimental group: 15 volunteers used the eye drops provided in this embodiment for eye atomization every day.

[0163] Control group: 15 volunteers used a common over-the-counter eye wash (Zhenshiming Little Yellow Duck).

[0164] Usage method:

[0165] Use it once in the morning and once in the evening every day, each time for 2 - 3 minutes, and keep the eyes closed for 1 - 2 minutes after atomization.

[0166] Evaluation criteria:

[0167] Eye comfort: Evaluate through a self-reported rating scale (Visual Fatigue Rating Scale, VAS scale).

[0168] Dry eye symptoms: Evaluated using the Ocular Surface Disease Index (OSDI).

[0169] Ocular physiological indicators: Measuring the tear break-up time (BUT) and ocular comfort.

[0170] Collect evaluation data before and after the experiment, and record the symptom changes of eye fatigue. The experimental data are shown in Table 1:

[0171] Table 1

[0172]

[0173]

[0174] Comparison between the experimental group and the control group: Through statistical analysis (t-test / ANOVA), the experimental group showed significant improvement in multiple indicators, especially in terms of eye fatigue, dryness, and comfort, and the difference was statistically significant (p < 0.05).

[0175] Overall conclusion: The eye drops provided by this embodiment have significant effects in relieving eye fatigue, dryness, and improving ocular comfort. Compared with the control group, the improvement in the experimental group is more obvious, proving the effectiveness of this product.

[0176] In this article, specific examples are used to elaborate on the principles and implementation methods of the present invention. The descriptions of the above embodiments are only used to help understand the method and its core idea of the present invention. The above are only the preferred implementation methods of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention, according to the technical solution and inventive concept of the present invention, makes equivalent substitutions or changes, and should be within the protection scope of the present invention.

Claims

1. An eye protection solution, characterized in that: The invention comprises the following components: by mass percentage, 1.0% to 5.0% of golden chrysanthemum hydrosol, 0.05% to 0.5% of golden chrysanthemum extract, 1.0% to 5.0% of buddleja flower hydrosol, 0.05% to 0.5% of buddleja flower extract, 0.05% to 1.0% of green tea extract, 0.5% to 1.0% of sodium chloride, 0.1% to 2.0% of buffer, and the balance is ultrapure water.

2. The eye protection solution according to claim 1, characterized in that The components include: 3% golden chrysanthemum hydrosol, 0.2% golden chrysanthemum extract, 3% buddleja buddleja buddleja extract, 0.2% green tea extract, 0.5% buffer, 1.6% and sodium chloride 0.9%.

3. A preparation method for preparing the eye protection solution according to claim 1 or 2, characterized in that: The steps include: a): Preparation of golden chrysanthemum hydrosol and extract, buddleja buddleja hydrosol and extract, and green tea extract; b): dissolving the buffer pair and sodium chloride in ultrapure water to obtain a buffer solution; c) adding the golden chrysanthemum hydrosol and extract, buddleja buddleja hydrosol and extract, and green tea extract to the buffer solution and mixing them evenly; d): Determine and adjust the osmotic pressure of the solution and adjust the pH value to 6.8-7.5; e): Filtration, sterilization and packaging.

4. The preparation method according to claim 3, characterized in that: The golden chrysanthemum hydrosol and extract, buddleja buddleja hydrosol and extract are prepared by a method of first distillation extraction and then solvent extraction; The green tea extract is prepared by a solvent extraction method.

5. The preparation method according to claim 4, characterized in that: The method of first distillation extraction and then solvent extraction specifically comprises: crushing the dried golden chrysanthemum or Buddleja buddleja, soaking the crushed raw material with purified water at a solid-liquid ratio of 1:15 to obtain a first extract, heating and distilling the first extract for 2 hours, collecting the cooled liquid through a condenser to obtain golden chrysanthemum / Buddleja buddleja hydrosol; filtering the first extract and concentrating it under reduced pressure to obtain golden chrysanthemum / Buddleja buddleja extract; The solvent extraction method specifically comprises: crushing the dried green tea, soaking the crushed raw material with purified water at a material-liquid ratio of 1:10 to obtain a second extract, heating the second extract under reflux for 30 minutes, filtering and concentrating under reduced pressure to obtain a green tea extract.

6. The preparation method according to claim 5, characterized in that: The heating and distillation temperature of the first extract is 40-60° C. The second extract is heated to reflux at a temperature of 60 to 80°C; Ultrasonic treatment is continuously performed using an ultrasonic device during the heating and distillation process of the first leachate and the heating and reflux process of the second leachate.

7. The preparation method according to claim 3, characterized in that: Step c) specifically includes the following sub-steps: c1): Mix and evenly disperse the golden chrysanthemum hydrosol, buddleja hydrosol and PLGA; c2): mixing Tween 80 and Span 80 to form a surfactant component liquid; c3): adding the mixture obtained in step c1 to the surfactant component liquid, and emulsifying the mixed liquid using a high shear homogenizer or ultrasonic equipment to form a nano-scale emulsion; c4): adding the golden chrysanthemum extract, buddleja extract and green tea extract into ultrapure water, stirring and dispersing them uniformly to obtain a mixed solution; c5): the nanoscale emulsion obtained in step c3 and the mixed solution obtained in step c4 are mixed and dispersed uniformly.

8. The preparation method according to claim 7, characterized in that: The PLGA in step c1 is a modified PLGA mixed component, and the modified PLGA mixed component includes: by mass percentage, 40% to 50% chitosan copolymer PLGA, 25% to 35% amino PLGA, and 20% to 30% carboxyl PLGA.

9. The preparation method according to claim 8, characterized in that: The preparation of the chitosan copolymer PLGA comprises the following steps: Dissolving PLGA in a mixed solution of ethanol and water to prepare a first solution with a concentration of 5% to 10%; Dissolve chitosan in acetic acid solution or water, and heat to 40-50° C. to prepare chitosan solution; Slowly add the chitosan solution into the first solution and mix well using magnetic stirring or high-speed stirring; At 0-5°C, adding epoxy compound to carry out copolymerization reaction; After stirring the reaction for 24 h, the unreacted solvent and cross-linking agent were removed by solvent exchange method; The solvent is removed by freeze drying or vacuum drying; and / or The preparation of the amino PLGA comprises the following steps: dissolving PLGA in a mixed solution of ethanol and water to prepare a second solution with a concentration of 5% to 10%; Add aminoacetic acid or triethanolamine to the second solution and stir at room temperature for 6 to 12 hours; The modified PLGA is washed with water to remove the residual reagent, and the solvent is removed by freeze drying or vacuum drying to obtain the product; and / or The preparation of the carboxylated PLGA comprises the following steps: dissolving PLGA in a mixed solution of ethanol and water to prepare a third solution with a concentration of 5% to 10%; Add succinic acid to the third solution and react at 60-80° C. for 4-6 hours; The modified PLGA is washed with water to remove the residual reagent, and then the solvent is removed by freeze drying or vacuum drying.

10. The preparation method according to claim 7, characterized in that: In step c2, Tween 80 and Span 80 are surfactants after surface modification by graft copolymerization, and the graft copolymerization method comprises the following steps: Weigh Tween 80 or Span 80 and dissolve it in anhydrous ethanol to obtain a surfactant solution with a concentration of 5 to 10 wt %; Dissolving dimethyldiallylammonium chloride in anhydrous ethanol to prepare a first monomer solution with a concentration of 5 to 10 wt %; Dissolving polyvinyl alcohol or polyvinyl pyrrolidone in water to prepare a second monomer solution with a concentration of 5 to 10 wt %; The first and second monomer solutions were mixed in a molar ratio of 1:2, and then added to the surfactant solution, and stirred evenly; Heating to 60-70°C, adding hydrogen peroxide to initiate free radical polymerization, controlling the reaction temperature at 60-70°C, the reaction time at 2-4h, wherein the amount of hydrogen peroxide used is 1-2wt%; After the reaction is completed, a neutralizing agent is added to adjust the pH of the reaction solution to 6.8-7.5; The solvent, unreacted monomers and impurities in the reaction solution are removed by aqueous extraction, and the residual solvent is removed by evaporation; The product is purified by centrifugation or gel permeation chromatography and low molecular weight impurities are removed.

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