A composition for preventing cataract, maculopathy and diabetic retinopathy, and a method of preparation and use thereof

Abstract

The present application provides a kind of composition and preparation method and application for preventing cataract, macular lesion and diabetic retinopathy, belong to biological medicine technical field.The composition of the present application includes: nano active ingredient, plant extract, glycyrrhizic acid dipotassium, nicotinamide, taurine, ikdoin, caffeine and lutein;Plant extract is composed of wild chrysanthemum flower extract and gentian extract;Nano active ingredient is composed of nano-encapsulated astaxanthin and nanometer retinol.The composition of the present application effectively inhibits key pathological links such as lens protein oxidative denaturation, retinal pigment epithelial cell function decline and pathological angiogenesis by multi-dimensional synergistic mechanism of antioxidant-anti-inflammatory-vascular protection-metabolic regulation, thereby realizing the prevention and adjuvant therapy effect on three major blinding eye diseases of cataract, age-related macular degeneration and diabetic retinopathy.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, specifically to a composition for preventing cataracts, macular degeneration, and diabetic retinopathy, as well as its preparation method and application. Background Technology

[0002] The eyes are one of the most important sensory organs in the human body. However, with the aging population, the surge in screen time, and the rising prevalence of metabolic diseases such as diabetes, the incidence of age-related eye diseases is showing a global upward trend. Among them, cataracts, age-related macular degeneration (AMD), and diabetic retinopathy (DR) are currently the leading eye diseases causing vision impairment and even blindness, severely impacting patients' quality of life and imposing a huge social and medical burden.

[0003] While surgical treatments (such as phacoemulsification for cataracts) and anti-VEGF drug injections (for wet AMD and DR) exist for the aforementioned eye diseases, these methods are often costly and invasive, and effective treatments for diseases like dry AMD are still lacking. Therefore, developing a preventative product that enables early intervention, is safe, effective, and easy to use has significant clinical and social implications.

[0004] While some existing eye care products, such as oral supplements (containing lutein, zeaxanthin, vitamin C / E, etc.), have been shown to have certain benefits, their bioavailability is limited and requires long-term use. Eye patches, as a transdermal topical dosage form, can penetrate the skin around the eyes, allowing active ingredients to bypass the first-pass effect of the liver and act more directly on eye tissues, potentially becoming an innovative means of prevention and adjunctive intervention.

[0005] However, most eye patch products on the market currently have limited efficacy, focusing primarily on relieving eye strain and lacking scientifically formulated compound formulations that address the common pathological mechanisms of the three major blinding eye diseases mentioned above (such as oxidative stress, inflammation, and vascular abnormalities). Therefore, there is an urgent need to develop a specially designed eye patch composition that can target multiple points and work synergistically to provide a novel non-invasive solution for the prevention of cataracts, AMD, and DR. Summary of the Invention

[0006] The purpose of this invention is to provide a composition for preventing cataracts, macular degeneration, and diabetic retinopathy, as well as a method for its preparation and application. The composition provided by this invention has a positive preventive effect on eye diseases.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0008] This invention provides a composition for preventing cataracts, macular degeneration, and diabetic retinopathy, comprising the following raw materials in parts by weight: 1-2 parts of nano-active ingredient, 8-12 parts of plant extract, 0.3-0.5 parts of dipotassium glycyrrhizate, 0.5-1 part of nicotinamide, 1-2 parts of taurine, 0.5-1 part of ectoine, 3-5 parts of caffeine, 3-5 parts of lutein, and 5-8 parts of glycerin; wherein the plant extract is composed of wild chrysanthemum extract and gentian extract in a mass ratio of (5-10):(1-3); and the nano-active ingredient is composed of nano-encapsulated astaxanthin and nano-retinol in a mass ratio of (0.5-1):(0.5-1).

[0009] Preferably, the preparation method of the wild chrysanthemum extract includes: crushing wild chrysanthemum and mixing it with water to prepare a liquid culture medium, inoculating it with compound microorganisms for anaerobic fermentation, and then obtaining the wild chrysanthemum extract through microfiltration and nanofiltration.

[0010] More preferably, the composite microorganism consists of Bifidobacterium longum CCFM1029 and Lactobacillus fumigatus CICC 6129.

[0011] Preferably, the preparation method of the gentian extract includes: freezing fresh gentian roots and then freeze-drying them under vacuum, pulverizing them, and then extracting them with ethanol solution by ultrasonication and purifying them with macroporous adsorption resin to obtain the gentian extract.

[0012] Preferably, the preparation method of the nano-encapsulated astaxanthin includes: mixing astaxanthin oil, medium-chain triglycerides and soybean lecithin to obtain an oil phase; adding the oil phase to a yeast β-glucan solution and homogenizing to obtain a nanoemulsion; adding a quaternary ammonium salt chitosan solution to the nanoemulsion, maturing and drying to obtain nano-encapsulated astaxanthin.

[0013] Preferably, the preparation method of the nano-retinol includes: mixing retinol, ascorbate palmitate, zein and anhydrous ethanol to obtain a protein solution; adding the protein solution to a pectin colloidal solution, adjusting the pH value to 3.8-4.2, distilling under reduced pressure, and drying to obtain nano-retinol.

[0014] The present invention also provides a method for preparing the above composition, comprising: mixing dipotassium glycyrrhizate, nicotinamide, taurine, ectoine and water to obtain an aqueous phase; mixing caffeine, lutein and glycerol to obtain an oil phase; adding the oil phase to the aqueous phase, homogenizing, adding nano-active ingredients and plant extracts, stirring, and obtaining the composition.

[0015] The present invention also provides an application of the above composition in the preparation of products for the prevention and treatment of eye diseases.

[0016] Preferably, the eye disease is cataract, macular degeneration, or diabetic retinopathy.

[0017] Preferably, the product is a topical preparation.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] This invention provides a composition for preventing cataracts, macular degeneration, and diabetic retinopathy, comprising: nano-active ingredients, plant extracts, dipotassium glycyrrhizate, nicotinamide, taurine, ectoine, caffeine, and lutein; the plant extracts are composed of wild chrysanthemum extract and gentian extract; the nano-active ingredients are composed of nano-encapsulated astaxanthin and nano-retinol.

[0020] The nano-active ingredients in this invention provide deep antioxidant protection and regulate cellular metabolism; plant extracts exert anti-inflammatory and microcirculation-improving effects; dipotassium glycyrrhizate and ectoine synergistically enhance anti-inflammatory and soothing repair effects; nicotinamide and taurine work together to maintain cellular energy metabolism and osmotic pressure balance; caffeine promotes microcirculation and relieves edema; lutein acts as a blue light filter, protecting retinal photoreceptor cells. Through a multi-dimensional synergistic mechanism of antioxidant-anti-inflammatory-vascular protection-metabolic regulation, the composition effectively inhibits key pathological processes such as lens protein oxidative denaturation, retinal pigment epithelial cell dysfunction, and pathological angiogenesis, thereby achieving preventive and adjunctive therapeutic effects against three major blinding eye diseases: cataracts, age-related macular degeneration, and diabetic retinopathy. Detailed Implementation

[0021] This invention provides a composition for preventing cataracts, macular degeneration, and diabetic retinopathy, comprising the following raw materials in parts by weight: 1-2 parts of nano-active ingredient, 8-12 parts of plant extract, 0.3-0.5 parts of dipotassium glycyrrhizate, 0.5-1 part of nicotinamide, 1-2 parts of taurine, 0.5-1 part of ectoine, 3-5 parts of caffeine, 3-5 parts of lutein, and 5-8 parts of glycerin; wherein the plant extract is composed of wild chrysanthemum extract and gentian extract in a mass ratio of (5-10):(1-3); and the nano-active ingredient is composed of nano-encapsulated astaxanthin and nano-retinol in a mass ratio of (0.5-1):(0.5-1).

[0022] The preferred method for preparing the wild chrysanthemum extract of the present invention includes: pulverizing wild chrysanthemum and mixing it with water to prepare a liquid culture medium, inoculating it with a complex of microorganisms for anaerobic fermentation, and then microfiltration and nanofiltration to obtain the wild chrysanthemum extract. A more preferred method for preparing the wild chrysanthemum extract includes: inoculating the liquid culture medium with a complex of microorganisms, fermenting at 35-40℃ for 48-72 hours, sterilizing the fermentation broth, microfiltration at 0.22-0.65 μm, filtering the permeate through a nanofiltration membrane with a molecular cutoff of 500-1000 Da until the cutoff solution is 1 / 8-1 / 10 of the permeate volume, concentrating, and drying to a water content of 1wt%-5wt% to obtain the wild chrysanthemum extract. The composite microorganism is preferably composed of Bifidobacterium longum CCFM1029 and Lactobacillus fragrans CICC 6129. The number of Bifidobacterium longum CCFM1029 in the composite microorganism is preferably 100 million to 300 million CFU / g, more preferably 200 million CFU / g, and the number of Lactobacillus fragrans CICC6129 is preferably 300 million to 500 million CFU / g, more preferably 400 million CFU / g. The inoculation amount of the composite microorganism is preferably 3% to 5% of the mass of the liquid culture medium, more preferably 4%.

[0023] This invention utilizes specific microbial fermentation of wild chrysanthemum, which not only improves the dissolution rate of active ingredients but also generates new active substances through biotransformation, enhancing the overall efficacy of the extract. The wild chrysanthemum extract prepared using this invention exhibits antioxidant, anti-inflammatory, and microcirculation-improving effects. Its rich content of flavonoids, glycosides, and other active ingredients effectively eliminates reactive oxygen species generated by photodamage and metabolic abnormalities, inhibiting oxidative stress damage to lens epithelial cells and retinal pigment epithelial cells, thus intervening in the pathological process of cataracts and macular degeneration at its source. Simultaneously, this extract significantly inhibits the activation of inflammatory signaling pathways and reduces the expression of various inflammatory factors, effectively alleviating key inflammatory responses and vascular leakage in eye diseases such as diabetic retinopathy. Furthermore, its blood-activating and stasis-removing effects help improve ocular microcirculation disorders, providing more adequate blood perfusion to tissues such as the retina, and synergistically constructing a multi-target eye disease prevention system with other components.

[0024] The preferred method for preparing the gentian extract of the present invention includes: freezing fresh gentian roots, followed by vacuum freeze-drying, pulverizing, and then ultrasonically extracting with ethanol solution and purifying with macroporous adsorption resin to obtain the gentian extract. A more preferred method for preparing the gentian extract includes: cutting fresh gentian roots into 2-3 mm thin slices, rapidly freezing at -38~-42℃ for 2-3 hours, then vacuum freeze-drying at a cold trap temperature of -43℃~-48℃ and a vacuum degree of 15-25 Pa until the water content is 1wt%-3wt%, pulverizing and passing through a 50-100 mesh sieve to obtain gentian freeze-dried powder; and mixing the gentian freeze-dried powder with a 65%-75% (v / v) ethanol solution at a ratio of 1:10-15. Mix g / mL and extract 1-3 times with ultrasound at 400-500W and 50-60℃ for 20-40 min each time. Filter, combine the filtrates, concentrate the filtrate to 1 / 3-1 / 5 of the filtrate volume, adsorb onto macroporous adsorption resin, and elute sequentially with 3-5 BV deionized water and 4-6 BV 70%-80% ethanol solution. Collect the ethanol eluent, concentrate, and dry to a water content of 1wt%-4wt% to obtain gentian extract.

[0025] The gentian extract described in this invention exerts multiple core effects primarily through its high content of iridoid glycosides (such as gentiopicroside). This extract possesses remarkable anti-inflammatory activity, effectively inhibiting inflammatory signaling pathways and the production of key inflammatory mediators, thereby alleviating tissue damage associated with chronic inflammation in eye diseases. Simultaneously, it exhibits significant antioxidant capacity, helping to scavenge excess reactive oxygen species and protect retinal pigment epithelial cells and lens cells from oxidative stress. Furthermore, it improves microcirculation and vascular permeability, synergistically enhancing the composition's preventative and therapeutic effects on fundus vascular lesions.

[0026] The plant extracts of this invention target multiple pathological aspects of ocular diseases, exhibiting antioxidant, anti-inflammatory, and microcirculation-improving effects. They significantly inhibit the activation of key inflammatory pathways, reduce the cumulative damage of oxidative stress and chronic inflammation to the lens, retina, and fundus blood vessels, thereby synergistically enhancing the comprehensive preventive ability against cataracts, macular degeneration, and diabetic retinopathy on multiple targets.

[0027] The preferred method for preparing nano-encapsulated astaxanthin according to the present invention includes: mixing astaxanthin oil, medium-chain triglycerides, and soybean lecithin to obtain an oil phase; adding the oil phase to a yeast β-glucan solution and homogenizing to obtain a nanoemulsion; adding a quaternary ammonium salt chitosan solution to the nanoemulsion, maturing, and drying to obtain nano-encapsulated astaxanthin. A more preferred method for preparing nano-encapsulated astaxanthin includes: mixing astaxanthin oil, medium-chain triglycerides, and soybean lecithin at a mass ratio of (0.8-1.2):(1.5-2.5):(0.25-0.35) at 400-600 rpm and 45-55°C for 20-30 min to obtain an oil phase; mixing yeast β-glucan and deionized water at a mass ratio of (0.8-1.2):100 at 600-800 rpm and 58-63°C for 2-3 h to obtain an aqueous phase; and mixing the aqueous phase at 8000-10000 rpm. The oil phase is dropped into the aqueous phase at a speed of rpm, sheared for 3-7 min, and then homogenized at 55-65 MPa for 1-3 min to obtain a nanoemulsion. At a speed of 400-600 rpm, a 3-6 g / L quaternary ammonium salt chitosan solution is dropped into the nanoemulsion, stirred and matured at 250-350 rpm for 40-50 min, concentrated, and dried to a water content of 2wt%-5wt% to obtain nano-encapsulated astaxanthin. The volume ratio of the oil phase, aqueous phase, and quaternary ammonium salt chitosan solution is preferably 1:(15-20):(8-12), more preferably 1:18:10.

[0028] The core function of the nano-encapsulated astaxanthin described in this invention is as a photodamage protectant. Through a unique nano-encapsulation technology, it significantly improves the water dispersibility, stability, and bioavailability of astaxanthin in ocular tissues. It can efficiently penetrate biological barriers, target and accumulate in the retina and lens, inhibit photooxidative damage to retinal pigment epithelial cells and the formation of lipofuscin, and slow the progression of macular degeneration. Simultaneously, by reducing the oxidative cross-linking of lens proteins, it plays a crucial role in the prevention of cataracts.

[0029] The preferred method for preparing nano-retinol according to the present invention includes: mixing retinol, ascorbate palmitate, zein and anhydrous ethanol to obtain a protein solution; adding the protein solution to a pectin colloidal solution, adjusting the pH value to 3.8-4.2, distilling under reduced pressure, and drying to obtain nano-retinol. The preferred method for preparing the nano-retinol includes: mixing retinol, ascorbate palmitate, zein, and anhydrous ethanol at a mass ratio of 1:(0.2-0.3):(3-5):(75-85) at 300-400 rpm for 40-50 min to obtain a protein solution; adding 3-4 g / L pectin colloidal solution (pectin prepared by stirring in deionized water) to the protein solution at 600-800 rpm, stirring for 8-12 min, adjusting the pH of the system to 3.8-4.2 with 0.1 M hydrochloric acid solution, maintaining stirring at 600-800 rpm for 28-33 min, concentrating, and drying to a water content of 2wt%-5wt% to obtain nano-retinol. The volume ratio of the protein solution to the pectin colloidal solution is preferably 1:(4-6), more preferably 1:5.

[0030] This invention relates to nano-retinol, a key active ingredient for cell metabolism regulation and tissue repair. Through nanotechnology, its stability and transdermal permeability are significantly enhanced, enabling it to act gently and continuously on the periocular and deep ocular tissues. Nano-retinol can effectively promote the normal differentiation and renewal of retinal pigment epithelial cells and corneal epithelial cells, regulate extracellular matrix remodeling, and inhibit abnormal angiogenesis, thereby delaying the pathological progression of macular degeneration and diabetic retinopathy. Simultaneously, by optimizing fibroblast function, it helps maintain the structural integrity of ocular connective tissue, working synergistically with other ingredients to construct a multi-layered ocular health defense and repair system.

[0031] The nano-active ingredients in this invention solve the challenges of stability and transdermal absorption through nanotechnology, achieving highly efficient delivery to target tissues in the eye. Nano-encapsulated astaxanthin acts as a potent photodamage protectant and antioxidant, primarily scavenging free radicals and inhibiting photo-oxidative damage; nano-retinol focuses on regulating cell metabolism, promoting tissue repair and inhibiting abnormal angiogenesis. The nano-active ingredients provide multi-target, systemic protection against multiple pathological stages of cataracts, macular degeneration, and diabetic retinopathy.

[0032] This invention enhances the preventive efficacy of eye diseases through a multi-level synergistic mechanism combining nano-active ingredients and plant extracts. The nano-active ingredients (astaxanthin and retinol) provide high-intensity antioxidant and cellular metabolism regulation, while the plant extracts (wild chrysanthemum and gentian) exert broad-spectrum anti-inflammatory and microcirculation-improving effects. Together, they construct a complete defense chain of antioxidant-anti-inflammatory-tissue repair: the plant extracts inhibit inflammation initiation upstream, creating a stable environment for the nano-ingredients; the nano-ingredients precisely scavenge deep-seated free radicals and promote cell repair downstream, and their antioxidant effects are superimposed on the plant extracts, jointly reducing the cumulative damage to the retina and lens caused by oxidative stress and inflammatory responses, achieving a synergistic protective effect.

[0033] The nano-active ingredients in this invention provide deep antioxidant protection and regulate cellular metabolism; plant extracts exert anti-inflammatory and microcirculation-improving effects; dipotassium glycyrrhizate and ectoine synergistically enhance anti-inflammatory and soothing repair effects; nicotinamide and taurine work together to maintain cellular energy metabolism and osmotic pressure balance; caffeine promotes microcirculation and relieves edema; lutein acts as a blue light filter, protecting retinal photoreceptor cells. Through a multi-dimensional synergistic mechanism of antioxidant-anti-inflammatory-vascular protection-metabolic regulation, the composition effectively inhibits key pathological processes such as lens protein oxidative denaturation, retinal pigment epithelial cell dysfunction, and pathological angiogenesis, thereby achieving preventive and adjunctive therapeutic effects against three major blinding eye diseases: cataracts, age-related macular degeneration, and diabetic retinopathy.

[0034] The present invention also provides a method for preparing the above composition, comprising: mixing dipotassium glycyrrhizate, nicotinamide, taurine, ectoine and water to obtain an aqueous phase; mixing caffeine, lutein and glycerol to obtain an oil phase; adding the oil phase to the aqueous phase, homogenizing, adding nano-active ingredients and plant extracts, stirring, and obtaining the composition.

[0035] The present invention also provides an application of the above composition in the preparation of products for the prevention and treatment of eye diseases.

[0036] Preferably, the eye disease is cataract, macular degeneration, or diabetic retinopathy.

[0037] Preferably, the product is a topical preparation.

[0038] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0039] Unless otherwise specified, the following embodiments are all conventional methods.

[0040] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0041] The liquid culture medium in the examples and comparative examples was prepared as follows: wild chrysanthemum powder (dried wild chrysanthemum powder pulverized through a 100-mesh sieve), casein peptone, beef extract powder, glucose and water were mixed and sterilized at 121°C for 15 min to obtain liquid culture medium; the concentrations of each component in the liquid culture medium were as follows: wild chrysanthemum powder 15 g / L, casein peptone 10 g / L, beef extract powder 10 g / L, and glucose 20 g / L.

[0042] Bifidobacterium longum CCFM1029 was obtained from the Guangdong Provincial Center for Microbial Culture Collection, with accession number GDMCC No. 60461, and is disclosed in patent CN109652349A; Lactobacillus farraginis CICC 6129 was obtained from the China Industrial Microbial Culture Collection Center; Bifidobacterium adolescentis strain ZJ2 was obtained from the China Industrial Microbial Culture Collection Center, with accession number CGMCC NO. 18901, and is disclosed in patent CN112725219A; Lactobacillus brevis CICC 20269 was obtained from the China Industrial Microbial Culture Collection Center.

[0043] Example 1

[0044] Compositions for preventing cataracts, macular degeneration, and diabetic retinopathy

[0045] (1) Preparation of plant extracts

[0046] The compound microorganism consisted of Bifidobacterium longum CCFM1029 and Lactobacillus fragrans CICC 6129. The number of Bifidobacterium longum CCFM1029 was 200 million CFU / g, and the number of Lactobacillus fragrans CICC 6129 was 400 million CFU / g. The compound microorganism was inoculated into a liquid culture medium containing wild chrysanthemum pollen at 4% of the liquid culture medium mass. Anaerobic fermentation was carried out at 37℃ for 60 h. After sterilization of the fermentation broth, it was microfiltered through 0.45 μm. The permeate was filtered through a nanofiltration membrane with a molecular cutoff of 800 Da until the cutoff solution was 1 / 9 of the permeate volume. The solution was concentrated and dried to a water content of 3 wt% to obtain wild chrysanthemum extract.

[0047] Fresh gentian root was cut into 2-3 mm thin slices, quick-frozen at -40℃ for 2.5 h, and then freeze-dried under vacuum at -45℃ and 20 Pa to a water content of 2 wt%. The dried gentian root was then pulverized and passed through an 80-mesh sieve to obtain gentian freeze-dried powder. The gentian freeze-dried powder was mixed with 70% ethanol solution at a ratio of 1:12 g / mL and extracted twice by ultrasonication at 450 W and 55℃ for 30 min each time. The mixture was filtered, and the filtrates were combined. The filtrate was concentrated to 1 / 4 of its volume and then adsorbed onto a macroporous adsorption resin. The filtrate was then eluted sequentially with 4 BV of deionized water and 5 BV of 75% ethanol solution. The ethanol eluent was collected, concentrated, and dried to a water content of 3 wt% to obtain gentian extract.

[0048] Wild chrysanthemum extract and gentian extract were mixed at a mass ratio of 8:2 to obtain the plant extract.

[0049] (2) Preparation of nano-active ingredients

[0050] Astaxanthin oil, medium-chain triglycerides, and soybean lecithin were stirred at 500 rpm and 50°C for 25 min at a mass ratio of 1:2:0.3 to obtain an oil phase. Yeast β-glucan and deionized water were stirred at 700 rpm and 60°C for 2.5 h at a mass ratio of 1:100 to obtain an aqueous phase. The oil phase was added dropwise to the aqueous phase at 9000 rpm, sheared for 5 min, and then homogenized at 60 MPa for 2 min to obtain a nanoemulsion. A 5 g / L quaternary ammonium chitosan solution was added dropwise to the nanoemulsion at 500 rpm, stirred and matured at 300 rpm for 45 min, concentrated, and dried to a water content of 3 wt% to obtain nano-encapsulated astaxanthin. The volume ratio of the oil phase, aqueous phase, and quaternary ammonium chitosan solution was 1:18:10.

[0051] Retinol, ascorbate palmitate, zein, and anhydrous ethanol were mixed at a mass ratio of 1:0.25:4:80 and stirred at 350 rpm for 45 min to obtain a protein solution. The protein solution was then added to a 3.5 g / L pectin colloidal solution (prepared by stirring pectin in deionized water) at 700 rpm. After stirring for 10 min, the pH of the system was adjusted to 4.0 with 0.1 M hydrochloric acid solution. The mixture was then stirred at 700 rpm for 30 min to mature, concentrated, and dried to a water content of 4 wt% to obtain nano-retinol. The volume ratio of the protein solution to the pectin colloidal solution was 1:4.

[0052] Nano-encapsulated astaxanthin and nano-retinol were mixed at a mass ratio of 1:1 to obtain nano-active ingredients.

[0053] (3) Weighing

[0054] Based on 100 parts by weight, accurately weigh the following components: 1.5 parts of nano-active ingredients, 10 parts of plant extracts, 0.4 parts of dipotassium glycyrrhizate, 0.8 parts of nicotinamide, 1.5 parts of taurine, 0.8 parts of ectoine, 4 parts of caffeine, 4 parts of lutein, 7 parts of glycerin, with the remainder being deionized water.

[0055] (4) Preparation of the composition

[0056] Dipotassium glycyrrhizate, nicotinamide, taurine, and ectoine were mixed with deionized water at 78°C and stirred at 350 rpm for 20 min to obtain an aqueous phase. Caffeine, lutein, and glycerol at 50°C were mixed to obtain an oil phase. The oil phase was added dropwise to the aqueous phase and homogenized at 2500 rpm for 8 min. Nano-active ingredients and plant extracts were added sequentially and stirred at 250 rpm for 10 min to obtain the composition.

[0057] Example 2

[0058] Compositions for preventing cataracts, macular degeneration, and diabetic retinopathy

[0059] (1) Preparation of plant extracts

[0060] The compound microbial system consists of Bifidobacterium longum CCFM1029 and Lactobacillus fragrans CICC 6129. The number of Bifidobacterium longum CCFM1029 in the compound microbial system is 100 million CFU / g, and the number of Lactobacillus fragrans CICC 6129 is 300 million CFU / g.

[0061] A compound microorganism at 5% of the liquid culture medium mass was inoculated into a liquid culture medium containing wild chrysanthemum pollen and anaerobic fermented at 35°C for 72 h. After sterilization of the fermentation broth, it was filtered through a 0.22 μm microfiltration membrane. The permeate was then filtered through a nanofiltration membrane with a molecular cutoff of 500 Da until the cutoff solution was 1 / 8 of the permeate volume. The solution was then concentrated and dried to a water content of 5 wt% to obtain wild chrysanthemum extract.

[0062] Fresh gentian root was cut into 2-3 mm thin slices, quick-frozen at -38℃ for 3 h, and then freeze-dried under vacuum at -43℃ and 15 Pa to a water content of 3 wt%. The dried gentian root was then pulverized and passed through a 50-mesh sieve to obtain gentian freeze-dried powder. The gentian freeze-dried powder was mixed with a 65% ethanol solution at a ratio of 1:10 g / mL and extracted three times by ultrasonication at 400 W and 50℃ for 20 min each time. The mixture was filtered, and the filtrates were combined. The filtrate was concentrated to 1 / 3 of its volume and then adsorbed onto a macroporous adsorption resin. The filtrate was then eluted sequentially with 3 BV of deionized water and 4 BV of 70% ethanol solution. The ethanol eluent was collected, concentrated, and dried to a water content of 2 wt% to obtain gentian extract.

[0063] Wild chrysanthemum extract and gentian extract were mixed at a mass ratio of 5:1 to obtain the plant extract.

[0064] (2) Preparation of nano-active ingredients

[0065] Astaxanthin oil, medium-chain triglycerides, and soybean lecithin were stirred at 400 rpm and 45°C for 30 min at a mass ratio of 0.8:1.5:0.25 to obtain an oil phase. Yeast β-glucan and deionized water were stirred at 600 rpm and 58°C for 3 h at a mass ratio of 0.8:100 to obtain an aqueous phase. The oil phase was added dropwise to the aqueous phase at 8000 rpm, sheared for 7 min, and then homogenized at 55 MPa for 3 min to obtain a nanoemulsion. A 3 g / L quaternary ammonium chitosan solution was added dropwise to the nanoemulsion at 400 rpm, stirred and matured at 250 rpm for 50 min, concentrated, and dried to a water content of 2 wt% to obtain nano-encapsulated astaxanthin. The volume ratio of the oil phase, aqueous phase, and quaternary ammonium chitosan solution was 1:15:8.

[0066] Retinol, ascorbate palmitate, zein, and anhydrous ethanol were mixed at a mass ratio of 1:0.2:3:75 and stirred at 300 rpm for 50 min to obtain a protein solution. A 3 g / L pectin colloidal solution (prepared by stirring pectin in deionized water) was added to the protein solution at 600 rpm. After stirring for 12 min, the pH of the system was adjusted to 3.8 with 0.1 M hydrochloric acid solution. The mixture was then stirred at 600 rpm for 33 min to mature, concentrated, and dried to a water content of 2 wt% to obtain nano-retinol. The volume ratio of the protein solution to the pectin colloidal solution was 1:4.

[0067] Nano-encapsulated astaxanthin and nano-retinol were mixed at a mass ratio of 0.5:1 to obtain nano-active ingredients.

[0068] (3) Weighing

[0069] Based on 100 parts by weight, accurately weigh the following components: 1 part of nano-active ingredient, 12 parts of plant extract, 0.3 parts of dipotassium glycyrrhizate, 1 part of nicotinamide, 1 part of taurine, 1 part of ectoine, 3 parts of caffeine, 5 parts of lutein, 5 parts of glycerin, with the remainder being deionized water.

[0070] (4) Preparation of the composition

[0071] Dipotassium glycyrrhizate, nicotinamide, taurine, ectoine, and deionized water at 75°C were mixed and stirred at 300 rpm for 23 min to obtain an aqueous phase. Caffeine, lutein, and glycerol at 48°C were mixed to obtain an oil phase. The oil phase was added dropwise to the aqueous phase and homogenized at 2300 rpm for 10 min. Nano-active ingredients and plant extracts were added sequentially and stirred at 200 rpm for 12 min to obtain the composition.

[0072] Example 3

[0073] Compositions for preventing cataracts, macular degeneration, and diabetic retinopathy

[0074] (1) Preparation of plant extracts

[0075] The compound microbial system consists of Bifidobacterium longum CCFM1029 and Lactobacillus fragrans CICC 6129. The number of Bifidobacterium longum CCFM1029 in the compound microbial system is 300 million CFU / g, and the number of Lactobacillus fragrans CICC 6129 is 500 million CFU / g.

[0076] A compound microorganism at 3% of the liquid culture medium mass was inoculated into a liquid culture medium containing wild chrysanthemum pollen and anaerobic fermented at 40°C for 48 hours. After sterilization of the fermentation broth, it was filtered through a 0.65μm microfiltration membrane. The permeate was then filtered through a nanofiltration membrane with a molecular cutoff of 1000Da until the cutoff solution was 1 / 10 of the permeate volume. The solution was then concentrated and dried to a water content of 2wt% to obtain wild chrysanthemum extract.

[0077] Fresh gentian root was cut into 2-3 mm thin slices, quick-frozen at -42℃ for 2 h, and then freeze-dried under vacuum at -48℃ and 25 Pa to a water content of 1 wt%. The dried gentian root was then pulverized and passed through a 100-mesh sieve to obtain gentian freeze-dried powder. The gentian freeze-dried powder was mixed with 75% ethanol solution at a ratio of 1:15 g / mL and ultrasonically extracted at 500 W and 60℃ for 40 min. The mixture was filtered, and the filtrate was concentrated to 1 / 5 of its volume. After adsorption with macroporous adsorption resin, the filtrate was eluted sequentially with 5 BV deionized water and 6 BV 80% ethanol solution. The ethanol eluent was collected, concentrated, and dried to a water content of 4 wt% to obtain gentian extract.

[0078] Wild chrysanthemum extract and gentian extract were mixed at a mass ratio of 10:3 to obtain the plant extract.

[0079] (2) Preparation of nano-active ingredients

[0080] Astaxanthin oil, medium-chain triglycerides, and soybean lecithin were stirred at 500 rpm and 50°C for 25 min at a mass ratio of 1.2:2.5:0.35 to obtain an oil phase. Yeast β-glucan and deionized water were stirred at 800 rpm and 63°C for 2 h at a mass ratio of 1.2:100 to obtain an aqueous phase. The oil phase was added dropwise to the aqueous phase at 10000 rpm, sheared for 3 min, and then homogenized at 65 MPa for 1 min to obtain a nanoemulsion. A 6 g / L quaternary ammonium chitosan solution was added dropwise to the nanoemulsion at 400 rpm, stirred and matured at 350 rpm for 40 min, concentrated, and dried to a water content of 2 wt% to obtain nano-encapsulated astaxanthin. The volume ratio of the oil phase, aqueous phase, and quaternary ammonium chitosan solution was 1:20:12.

[0081] Retinol, ascorbate palmitate, zein, and anhydrous ethanol were mixed at a mass ratio of 1:0.3:5:85 and stirred at 400 rpm for 40 min to obtain a protein solution. A 4 g / L pectin colloidal solution (prepared by stirring pectin in deionized water) was added to the protein solution at 800 rpm and stirred for 8 min. The pH of the system was adjusted to 4.2 with 0.1 M hydrochloric acid solution, and the mixture was stirred at 800 rpm for 28 min to mature. The mixture was then concentrated and dried to a water content of 3 wt% to obtain nano-retinol. The volume ratio of the protein solution to the pectin colloidal solution was 1:6.

[0082] Nano-encapsulated astaxanthin and nano-retinol were mixed at a mass ratio of 1:0.5 to obtain nano-active ingredients.

[0083] (3) Weighing

[0084] Based on 100 parts by weight, accurately weigh the following components: 2 parts nano-active ingredients, 8 parts plant extracts, 0.5 parts dipotassium glycyrrhizate, 0.5 parts nicotinamide, 2 parts taurine, 0.5 parts ectoine, 5 parts caffeine, 3 parts lutein, 8 parts glycerin, with the remainder being deionized water.

[0085] (4) Preparation of the composition

[0086] Dipotassium glycyrrhizate, nicotinamide, taurine, and ectoine were mixed with deionized water at 80°C and stirred at 380 rpm for 18 min to obtain the aqueous phase. Caffeine, lutein, and glycerol at 52°C were mixed to obtain the oil phase. The oil phase was added dropwise to the aqueous phase and homogenized at 3000 rpm for 5 min. Nano-active ingredients and plant extracts were added sequentially and stirred at 300 rpm for 7 min to obtain the composition.

[0087] Comparative Example 1

[0088] Unlike Example 1, in step (1), the composite microorganism consists of Bifidobacterium adolescentis strain ZJ2 and Lactobacillus brevis CICC 20269. The number of Bifidobacterium adolescentis strain ZJ2 in the composite microorganism is 200 million CFU / g, and the number of Lactobacillus brevis CICC 20269 is 400 million CFU / g. Other conditions remain unchanged.

[0089] Comparative Example 2

[0090] Unlike Example 1, in step (1), the pretreatment method of gentian root is as follows: cut fresh gentian root into thin slices of 2-3 mm, put them into a hot air drying oven, dry them at 45°C for 2 hours, dry them at 53°C until the moisture content is 2 wt%, pulverize them through an 80-mesh sieve, and obtain gentian powder.

[0091] Comparative Example 3

[0092] Unlike Example 1, in step (2), the preparation method of nano-encapsulated astaxanthin and nano-retinol is abandoned. Astaxanthin and retinol are mixed at a mass ratio of 1:1 to obtain the active ingredients.

[0093] Comparative Example 4

[0094] Unlike Example 1, the nano-active ingredients in step (3) were discarded, and the weight of the plant extract was adjusted to 11.5 parts, with the total raw material weight being the same as in Example 1.

[0095] Comparative Example 5

[0096] Unlike Example 1, the plant extract in step (3) was omitted, and the weight of the nano-active ingredient was adjusted to 11.5 parts. The total weight of the raw materials was the same as in Example 1.

[0097] Experimental Example 1

[0098] Animal experiments on cataract prevention

[0099] Eighty SPF-grade SD rats, half male and half female, weighing 200-220g, were selected and acclimatized for one week. The ambient temperature was 22-25℃, the humidity was 50%-60%, and there was a 12-hour light-dark cycle. They were allowed free access to food and water.

[0100] 0.1g of the compositions prepared in Example 1 and Comparative Examples 1-5 were dropped into circular medical nonwoven fabric substrates with a diameter of 1.5-2cm to be tested.

[0101] Baseline lens transparency was assessed in all rats before the experiment, and all rats were initially in the same condition.

[0102] Rats were randomly divided into 8 groups: blank control group, model group, and experimental group (Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group and Comparative Example 5 group), with half males and half females in each group, and 10 rats in each group.

[0103] The model group and experimental group received daily subcutaneous injections of 5% D-galactose solution at a dose of 100 mg / kg in the neck and back. The blank control group received an equal volume of physiological saline. The experimental group underwent daily periorbital patch application (the skin around the rat's eyes was cleaned with physiological saline, the patch was applied, and a sterile cotton swab was used to gently press for 30 seconds to ensure adhesion; the rat's head was gently restrained with a rat restraint to prevent scratching; the patch was applied for 20 minutes, and after application, the patch was removed, and any residue around the eyes was gently wiped away with a sterile cotton swab). The blank control group and model group received blank saline-containing patch application (0.1 g of physiological saline was dropped into a circular medical non-woven fabric substrate with a diameter of 1.5-2 cm as the blank patch). This treatment was continued for 8 weeks.

[0104] After 8 weeks of experimentation, the lens opacity of each group of rats was observed using a slit-lamp microscope. The lens opacity was scored according to the lens opacity grading standard (Grade 0: transparent lens; Grade 1: slight peripheral lens opacity; Grade 2: moderate peripheral lens opacity, involving part of the cortex; Grade 3: most of the lens opacity, involving the cortex and nucleus; Grade 4: complete lens opacity). The average opacity grade of each group of rats was recorded after 8 weeks.

[0105] Rats in each group were sacrificed, and their lenses were quickly removed, rinsed thoroughly with physiological saline, blotted dry with filter paper, and weighed. The lenses were then placed in pre-cooled physiological saline and homogenized using a tissue homogenizer (mass-to-volume ratio 1:9). The homogenate was centrifuged at 12000 rpm for 15 min at 4°C, and the supernatant was collected. The levels of superoxide dismutase (SOD) and malondialdehyde (MDA) in the supernatant were detected using an ELISA kit.

[0106] The average opacity level of the lens of each group of rats and the content of SOD and MDA in the lens are shown in Table 1.

[0107] Table 1. Mean turbidity grade and SOD and MDA content of rats in each group

[0108]

[0109] As shown in Table 1, compared with the blank group, the model group had a much higher average opacity level, a significantly lower SOD content, and a much higher MDA content. This indicates that 5% D-galactose successfully constructed a cataract model, and the model group had severe oxidative damage to the lens.

[0110] Comparison between Example 1 group and model group: The average opacity level of Example 1 group was lower than that of the model group, the SOD content was close to that of the blank group, and the MDA content was significantly lower than that of the model group, indicating that the composition can significantly reduce lens opacity, enhance antioxidant capacity, reduce oxidative damage, and has a significant effect on cataract prevention.

[0111] Comparison with Example 1: The effects of all comparative examples were weaker than those of Example 1. Among them, Comparative Example 4, which lacked nano-active ingredients, and Comparative Example 5, which lacked plant extracts, showed the worst effects, indicating that nano-active ingredients and plant extracts are key raw materials for cataract prevention, and that nano-active ingredients and plant extracts have a synergistic effect in preventing and treating cataracts. Comparative Example 1, which used different microorganisms to prepare wild chrysanthemum extract, Comparative Example 2, which used hot air drying to prepare gentian extract, and Comparative Example 3, which did not contain nano-active ingredients, showed weaker effects, indicating that the specific preparation process of the raw materials (specific microbial fermentation, vacuum freeze drying, and nano-encapsulation) has a significant impact on the effect.

[0112] Experimental Example 2

[0113] Animal experiments on prevention of macular degeneration

[0114] Eighty SPF-grade C57BL / 6 mice, half male and half female, 12 months old, weighing 20-22g, were selected. They were acclimatized for one week in an environment with a temperature of 22-25℃, humidity of 50%-60%, 12-hour light-dark cycle, and free access to food and water.

[0115] All mice underwent baseline fundus examination before the experiment, and none of the mice showed any fundus lesions.

[0116] 0.05g of the compositions prepared in Example 1 and Comparative Examples 1-5 were dropped into circular medical nonwoven fabric substrates with a diameter of 1.2-1.5cm to be tested.

[0117] Mice were randomly divided into 8 groups: blank control group, model group, and experimental group (Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group and Comparative Example 5 group), with half males and half females in each group, and 10 mice in each group.

[0118] Every Monday, Wednesday, and Friday morning, except for the blank control group, mice were intraperitoneally injected with 200 μmol / L tert-butyl hydroperoxide (t-BHP) at a dose of 10 mL / kg. t-BHP induced oxidative damage in RPE cells, simulating the pathological process of AMD (Advanced Microsurgery) – chronic oxidative stress + age-related decline – in conjunction with the natural aging characteristics of 12-month-old mice. The blank control group received an equal volume of sterile saline intraperitoneally during the same period. Every afternoon, mice in the experimental group underwent periorbital patch treatment (the skin around the mice's eyes was cleaned with saline, the patch was applied for 20 minutes, and after application, the patch was removed, and any residue was gently wiped away with a sterile cotton swab). The blank control group and the model group received blank saline patches (0.05 g of saline was dropped into a circular medical non-woven fabric substrate with a diameter of 1.2-1.5 cm). This treatment was continued for 12 weeks.

[0119] Fundus morphology observation: Mice were anesthetized by intraperitoneal injection of 10% chloral hydrate, and mydriasis was performed (0.5% tropicamide eye drops were instilled). Fundus images of the posterior pole of both eyes were taken using a fundus camera. Three blind professionals scored the lesions according to the characteristics of AMD (scoring criteria: grade 0 = uniform reflection in the macular area, no pigmentary disturbance; grade 1 = punctate pigmentary disturbance in the macular area; grade 2 = patchy pigmentary disturbance in the macular area + a small number of drusen; grade 3 = confluent pigmentary disturbance in the macular area + a large number of drusen / local RPE atrophy). The average value was taken as the fundus lesion score for each group.

[0120] After observing the fundus morphology, mice were euthanized, and retinal tissue was collected. The retinal tissue was rinsed thoroughly with physiological saline, blotted dry with filter paper, and then homogenized with physiological saline at a mass-to-volume ratio of 1:9. The homogenate was prepared using a tissue homogenizer, centrifuged at 12,000 rpm for 15 min at 4°C, and the supernatant was collected. The levels of SOD and MDA in the retinal tissue supernatant were detected using an ELISA kit, strictly following the kit instructions. The degree of inflammatory response in each group of mice was analyzed.

[0121] The results of fundus lesion scores and SOD and MDA content in the retina of mice in each group are shown in Table 2.

[0122] Table 2. Fundus lesion scores and SOD and MDA contents of mice in each group.

[0123]

[0124] As shown in Table 2, compared with the control group, the model group had a significantly higher fundus lesion score, a significantly lower SOD content, and a higher MDA content. This indicates that t-BHP combined with natural aging successfully constructed a macular degeneration model, and the model group showed severe retinal oxidative damage and lesions.

[0125] Comparison between Example 1 group and model group: The fundus lesion score of Example 1 group was lower than that of the model group, the SOD content was higher than that of the model group, and the MDA content was lower than that of the model group. This indicates that the composition can significantly reduce macular lesions (such as pigmentary disorders and drusen), enhance the antioxidant capacity of the retina, reduce oxidative damage, and has a significant preventive effect on macular lesions.

[0126] Comparison with Example 1: The effects of the comparative examples were not as good as those of Example 1. Comparative examples 4 and 5 had the worst effects due to the lack of key raw materials, indicating that nano-active ingredients and plant extracts have a synergistic effect in the prevention and treatment of macular degeneration. The effects of comparative examples 1, 2, and 3 were weakened due to changes in the preparation process, further verifying the necessity of specific raw materials and processes for the prevention of macular degeneration.

[0127] Experimental Example 3

[0128] Animal experiments on the prevention of diabetic retinopathy

[0129] Eighty-five SPF-grade SD rats, half male and half female, weighing 200-220g, were selected and acclimatized for one week. The rearing environment was 22-25℃, with a humidity of 50%-60%, a 12-hour light-dark cycle, and free access to food and water.

[0130] All rats underwent baseline retinal fibrillation (FFA) examination prior to the experiment, and none of the rats showed retinal lesions.

[0131] 0.1g of the compositions prepared in Example 1 and Comparative Examples 1-5 were dropped into circular medical nonwoven fabric substrates with a diameter of 1.5-2cm to be tested.

[0132] Ten rats were randomly selected as blank controls. Except for the blank control group, the remaining rats were fasted for 12 hours but allowed free access to water, and then intraperitoneally injected with 10 mg / mL streptozotocin solution (solvent: 0.1 mol / L citrate-sodium citrate buffer, pH 4.5) at a dose of 60 mg / kg. The blank control group rats were injected with an equal volume of 0.1 mol / L citrate-sodium citrate buffer. 72 hours after injection, fasting blood glucose was measured by blood sample taken from the tail tip. If the blood glucose level was ≥16.7 mmol / L, the diabetes model was considered to have been successfully established. If the level was not reached, 10 mg / mL streptozotocin solution (30 mg / kg) was injected. The level was measured again after 1 week. Rats that still did not reach the level were eliminated. During the experiment, 3 rats (2 males and 1 female) were eliminated. 70 rats (35 males and 35 females) that met the criteria (successfully established diabetes model) were selected and randomly divided into 7 groups: model group and experimental group (Example 1, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4 and Comparative Example 5), with half males and half females in each group and 10 rats in each group.

[0133] After the diabetes model was successfully established, the experimental group mice were given eye patches around their eyes every day (the application method was the same as in Experiment 1), while the blank control group and the model group were given blank eye patches containing physiological saline (0.1g of physiological saline was dropped into a circular medical non-woven fabric substrate with a diameter of 1.5-2cm as a blank eye patch). The application method and duration were the same as in the experimental group, and the intervention was carried out continuously for 16 weeks.

[0134] Fasting blood glucose levels were measured by collecting blood from the tail tip of rats every two weeks to ensure that blood glucose levels in the model control group and each experimental group remained stable at ≥16.7 mmol / L. The mean blood glucose levels of each group of rats were statistically analyzed after 16 weeks of intervention.

[0135] After 16 weeks of intervention, rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 mL / kg), mydriasis was performed (0.5% tropicamide eye drops were instilled), and sodium fluorescein (10 mg / kg) was injected into the tail vein. Immediately afterward, fundus vascular images were captured using an FFA instrument to analyze whether typical diabetic retinopathy features such as "microaneurysms, vascular leakage, and capillary non-perfusion areas" appeared in the macular area and peripheral retinal vessels. The results were scored by three professionals in a double-blind manner (Grade 0: no abnormalities; Grade 1: 1-3 microaneurysms; Grade 2: ≥4 microaneurysms or slight leakage; Grade 3: significant leakage or non-perfusion areas). The average value was taken as the lesion score for each group.

[0136] After scoring each group of rats, retinal tissue from one side was taken, and pre-cooled physiological saline was added at a mass-to-volume ratio of 1:9. The tissue was homogenized in an ice bath using a tissue homogenizer, centrifuged at 12,000 rpm for 15 min at 4°C, and the supernatant was collected. The SOD activity and MDA content in the supernatant were detected according to the ELISA kit instructions.

[0137] The results of blood glucose levels, average lesion scores, SOD activity in the retina, and MDA content in each group of rats are shown in Table 3.

[0138] Table 3. Blood glucose levels, average lesion scores, and SOD activity and MDA content in the retina of rats in each group.

[0139]

[0140] As shown in Table 3, compared with the control group, the blood glucose level in the model group was 5.4 times that of the control group, the fundus lesion score was much higher in the model group, the SOD content was significantly lower in the model group, and the MDA content was significantly higher in the model group. This indicates that streptozotocin successfully constructed a model of diabetes and diabetic retinopathy. The model group showed severe blood glucose out-of-control, retinopathy (such as microaneurysms and leakage), and oxidative damage.

[0141] Comparison between Example 1 group and model group: The blood glucose level of Example 1 group was lower than that of the model group, the fundus lesion score was lower than that of the model group, the SOD content was significantly higher than that of the model group, and the MDA content was lower than that of the model group. This indicates that the composition can not only help regulate blood glucose, but also significantly reduce retinopathy and oxidative damage, and has a significant preventive effect on diabetic retinopathy.

[0142] Comparison with Example 1: The effects of the comparative examples were all weaker than those of Example 1. Comparative Examples 5 and 4 showed the worst lesion prevention effects due to the lack of key raw materials, indicating that the nano-active ingredients and plant extracts have a synergistic effect in preventing and treating diabetic retinopathy. The effects of Comparative Examples 1-3 were weakened due to changes in the process, further demonstrating that specific raw materials and preparation processes are the core of the composition's role in preventing diabetic retinopathy.

[0143] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition for preventing cataracts, macular degeneration, and diabetic retinopathy, characterized in that, The raw materials include the following parts by weight: 1-2 parts of nano-active ingredients, 8-12 parts of plant extracts, 0.3-0.5 parts of dipotassium glycyrrhizate, 0.5-1 part of nicotinamide, 1-2 parts of taurine, 0.5-1 part of ectoine, 3-5 parts of caffeine, 3-5 parts of lutein, and 5-8 parts of glycerin; the plant extracts are composed of wild chrysanthemum extract and gentian extract in a mass ratio of (5-10):(1-3); the nano-active ingredients are composed of nano-encapsulated astaxanthin and nano-retinol in a mass ratio of (0.5-1):(0.5-1). The preparation method of the wild chrysanthemum extract includes: crushing wild chrysanthemum and mixing it with water to prepare a liquid culture medium, inoculating it with compound microorganisms for anaerobic fermentation, and then obtaining the wild chrysanthemum extract through microfiltration and nanofiltration. The composite microorganism consists of Bifidobacterium longum CCFM1029 and Lactobacillus fragrans CICC 6129; The preparation method of the gentian extract includes: freezing fresh gentian roots, then freeze-drying them under vacuum, pulverizing them, and then extracting them with ethanol solution by ultrasonication and purifying them with macroporous adsorption resin to obtain the gentian extract.

2. The composition according to claim 1, characterized in that, The preparation method of the nano-encapsulated astaxanthin includes: mixing astaxanthin oil, medium-chain triglycerides and soybean lecithin to obtain an oil phase; adding the oil phase to a yeast β-glucan solution and homogenizing to obtain a nanoemulsion; adding a quaternary ammonium salt chitosan solution to the nanoemulsion, maturing and drying to obtain nano-encapsulated astaxanthin.

3. The composition according to claim 1, characterized in that, The preparation method of the nano-retinol includes: mixing retinol, ascorbate palmitate, zein and anhydrous ethanol to obtain a protein solution; adding the protein solution to a pectin colloidal solution, adjusting the pH value to 3.8-4.2, distilling under reduced pressure, and drying to obtain nano-retinol.

4. A method for preparing the composition according to any one of claims 1-3, characterized in that, include: Dipotassium glycyrrhizate, nicotinamide, taurine, and ectoine were mixed with water to obtain an aqueous phase; caffeine, lutein, and glycerin were mixed to obtain an oil phase; the oil phase was added to the aqueous phase, homogenized, and then nano-active ingredients and plant extracts were added and stirred to obtain the composition.

5. The use of the composition according to any one of claims 1-3 in the preparation of a medicament for the prevention and treatment of eye diseases; wherein the eye disease is cataract, macular degeneration, or diabetic retinopathy.

6. The application according to claim 5, characterized in that, The drug is a topical preparation.

Images