Compositions and their use in the manufacture of products for the prevention of ocular disease, slowing of visual acuity decline

Abstract

The present application relates to the field of medicine, in particular to a composition and its use in the preparation of a product for preventing eye diseases and slowing down visual acuity decline. The present application provides a composition comprising, in parts by weight, any two or more of a carotenoid complex 2-10 parts, a vitamin complex 0.1-1 part, a mineral complex 0.01-0.5 part, and a plant active complex 5-15 parts. The present application provides a composition and its use in the preparation of a product for preventing eye diseases and slowing down visual acuity decline.

Description

Technical Field

[0001] This invention relates to the pharmaceutical field, and more particularly to compositions and their use in the preparation of products that prevent eye diseases and slow down vision decline. Background Technology

[0002] With the widespread use of electronic products, people are spending more time and energy using their eyes. The high-energy blue light (380-450nm) emitted by electronic screens has become a major factor posing significant harm to the eyes, making it a major killer of vision in teenagers. As people age, especially after 45, the function of RPE cells in the eye declines, reducing the ability to metabolize blue light and increasing the risk of macular degeneration. In individuals with high myopia, the elongated eyeball makes the macula more vulnerable, and the combined mechanical traction from blue light further increases the probability of disease. Fundus diseases will severely impact learning, work, and daily life.

[0003] Currently, the prevention and treatment of this condition both involve supplementing with lutein and zeaxanthin. However, due to the fat-soluble nature of lutein, lutein esters, zeaxanthin, and racemic zeaxanthin, and their instability to acid and light, the absorption and utilization rates of most products are not high. Although some products microencapsulate lutein and lutein esters, their encapsulation rate and stability are not satisfactory.

[0004] Therefore, developing a product with high inclusion rate, stable properties, and high utilization rate is of positive and important significance for the prevention of eye diseases and the slowing down of vision decline. Summary of the Invention

[0005] In view of this, the present invention provides a composition and its use in the preparation of products having the effects of preventing eye diseases and slowing down vision decline. The present invention provides a composition and its use in the preparation of products having the effects of preventing eye diseases and slowing down vision decline.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] The present invention provides a composition comprising, in parts by weight:

[0008] The combination of any two or more of the following: 2-10 parts of carotenoid complex, 0.1-1 part of vitamin complex, 0.01-0.5 parts of mineral complex, and 5-15 parts of plant active complex.

[0009] In some embodiments of the present invention, the carotenoid complex in the above composition comprises: lutein ester, lutein, zeaxanthin and racemic zeaxanthin; the mass ratio of the lutein ester, the lutein, the zeaxanthin and the racemic zeaxanthin is 1.2:0.2:0.2:0.05.

[0010] In some embodiments of the present invention, the vitamin complex in the above composition comprises: vitamin A, vitamin D, vitamin E, vitamin B1 and vitamin B2; the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1 and vitamin B2 is 0.002:0.000004:0.03:0.004:0.004.

[0011] In some embodiments of the present invention, the mineral complex in the above composition comprises selenium and zinc; the mass ratio of selenium to zinc is 1:1.

[0012] In some embodiments of the present invention, the plant-active complex in the above composition comprises: blueberry extract, blueberry peptide and goji berry peptide; the mass ratio of the blueberry extract, the blueberry peptide and the goji berry peptide is 16:1:1.

[0013] In some embodiments of the present invention, the above composition further includes a carrier; said carrier includes one or more of β-cyclodextrin, maltodextrin, hydroxypropyl-β-cyclodextrin, sulfobutyl-β-cyclodextrin, microcrystalline cellulose, and lactose.

[0014] In some embodiments of the present invention, the carrier in the above composition is β-cyclodextrin and / or maltodextrin.

[0015] In some embodiments of the present invention, the above composition comprises, by weight, the following components:

[0016] 6.6 parts of carotenoid complex, 0.5 parts of vitamin complex, 0.1 parts of mineral complex, and 9 parts of plant active complex;

[0017] The carotenoid complex comprises: 1.2 parts lutein ester, 0.2 parts lutein, 0.2 parts zeaxanthin, 0.05 parts racemic zeaxanthin, and 4.95 parts cyclodextrin;

[0018] The vitamin complex comprises: 0.002 parts of vitamin A, 0.004 parts of vitamin B1, 0.004 parts of vitamin B2, 0.000004 parts of vitamin D, 0.03 parts of vitamin E, and 0.459996 parts of maltodextrin;

[0019] The mineral complex comprises: 0.05 parts zinc glycine and 0.05 parts selenium-enriched protein powder;

[0020] The plant-active complex comprises: 8 parts blueberry extract, 0.5 parts blueberry peptide, and 0.5 parts goji berry peptide.

[0021] The present invention also provides the use of the above composition in the preparation of products that reduce oxidative stress levels and / or enhance antioxidant enzyme activity.

[0022] In some embodiments of the present invention, the composition described above has any of the following applications;

[0023] (a) Reduce the content of malondialdehyde; and / or

[0024] (b) Increase the activity of superoxide dismutase; and / or

[0025] (c) Increase the activity of glutathione peroxidase.

[0026] The present invention also provides the use of the above composition in the preparation of products for preventing eye diseases, slowing down vision decline and / or relieving visual fatigue.

[0027] In some embodiments of the present invention, the composition has any of the following applications in the above-described applications;

[0028] (d) Prevention of macular degeneration; and / or

[0029] (e) Improve pigment density in the macular region of the retina; and / or

[0030] (f) Reduce pathological damage to the retina caused by blue light and / or strong light exposure.

[0031] In some embodiments of the present invention, in the above applications, the product includes one or more of the following: medicines, food, special medical foods, health products, functional foods, and dietary supplements.

[0032] The present invention also provides a medicine or health product comprising: the above-described composition and acceptable excipients.

[0033] In some embodiments of the present invention, the excipients in the above-mentioned drugs or health products include one or more of sweeteners, flavoring agents, and antioxidants.

[0034] In some embodiments of the present invention, the above-mentioned examples of excipients in the drugs or health products are only used to illustrate the types of excipients that can be used in the present invention and do not constitute a limitation on the scope of protection of the present invention. Within the scope of the concept of the present invention, those skilled in the art can select other suitable pharmaceutical or food-grade excipients according to actual needs such as formulation type, route of administration, and product taste.

[0035] For example, in addition to the aforementioned sweeteners, flavoring agents and antioxidants, the excipients may also include, but are not limited to, one or more of the following: fillers or diluents, disintegrants, lubricants or flow aids, binders, pH adjusters or buffers, stabilizers or preservatives, thickeners or suspending agents, coating materials, etc.

[0036] In practice, the above excipients can be combined and proportioned in any feasible way according to the characteristics of the dosage form (such as tablets, capsules, granules, oral liquids, etc.) and process requirements, as long as the stability and efficacy of each active ingredient in this invention are not affected.

[0037] In some embodiments of the present invention, the above-mentioned medicine or health product includes the following components:

[0038] Erythritol 220.8 parts, Vitamin C 4 parts, Citric acid 5 parts, Sweet orange flavor 2.5 parts, Monk fruit glycoside 1.5 parts, Plant active complex 9 parts (Blueberry extract 8 parts, Blueberry peptide 0.5 parts, Goji berry peptide 0.5 parts), Mineral complex 0.1 parts (Zinc glycine 0.05 parts, Selenium-enriched protein powder 0.5 parts), Vitamin complex 0.5 parts (Vitamin A, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, and maltodextrin in a mass ratio of 0.002:0.000004:0.03:0.004:0.004:0.459996), and Yellow carrot complex 6.6 parts (Lutein ester, Lutein, Zeaxanthin, Racemic Zeaxanthin, and Cyclodextrin in a mass ratio of 1.2:0.2:0.2:0.05:4.95).

[0039] The present invention also provides a method for preparing the above-mentioned drug or health product, wherein the carotenoid complex, the vitamin complex, the mineral complex, the plant active complex and the excipients are mixed, granulated and dried to obtain the drug or health product.

[0040] In some embodiments of the present invention, the above preparation method is used to prepare a mixture of cyclodextrin.

[0041] In some embodiments of the present invention, the above-described preparation method is merely one of the embodiments of the present invention and is not intended to limit the scope of protection of the present invention. Within the scope of the concept of the present invention, those skilled in the art can adopt other feasible preparation processes according to actual needs, as long as the above-described active components and excipients can be uniformly compounded and a stable formulation can be formed.

[0042] For example, the preparation method may include, but is not limited to, one or more combinations of the following: direct tableting, wet granulation, dry granulation, capsule filling, granule / powder preparation, oral liquid preparation, microencapsulation or embedding, etc. Furthermore, conventional auxiliary steps in the art may be introduced during the preparation process as needed, such as sieving, pulverizing, mixing, granulation, polishing, coating, sterilization, quality control, etc., without affecting the core technical effects of the present invention.

[0043] This invention combines zinc-selenium compositions, compound vitamins, peptide compositions, and lutein ester compositions in pairs, in threes, or in all fours, to produce a synergistic effect under specific ratios. The components of this composition are derived from ingredients that are both medicinal and edible, possessing multiple functions in preventing macular degeneration, aiding weight loss, and mitigating vision decline. It also has a good taste, high compliance, and good effects in combating oxidation, protecting against blue light damage, and improving symptoms of macular degeneration. Attached Figure Description

[0044] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.

[0045] Figure 1 This is a flowchart illustrating the present invention;

[0046] Figure 2 The immunohistochemical results of each group in Example 2 are compared. Detailed Implementation

[0047] This invention discloses the composition and its use in the preparation of products that prevent eye diseases and slow down vision decline.

[0048] It should be understood that the expression “one or more of…” individually includes each of the objects described after the expression, as well as various different combinations of two or more of the described objects, unless otherwise understood from the context and usage. The expression “and / or” combined with three or more described objects should be understood to have the same meaning, unless otherwise understood from the context.

[0049] The terms “including,” “having,” or “containing,” including the use of their grammatical synonyms, should generally be understood as open-ended and non-restrictive, for example, not excluding other unstated elements or steps, unless otherwise specifically stated or understood from the context.

[0050] It should be understood that the order of the steps or the order in which certain actions are performed is not important as long as the invention remains operational. Furthermore, two or more steps or actions can be performed simultaneously.

[0051] The use of any and all instances or exemplary language such as “e.g.” or “including” in this document is merely intended to better illustrate the invention and is not intended to limit the scope of the invention unless the claims are made. No language in this specification should be construed as indicating that any unclaimed element is essential to the practice of the invention.

[0052] Furthermore, the numerical ranges and parameters used to define the present invention are approximate values, and the relevant values ​​in the specific embodiments have been presented as precisely as possible. However, any value inevitably contains standard deviations due to individual test methods. Therefore, unless explicitly stated otherwise, it should be understood that all ranges, quantities, values, and percentages used in this disclosure are modified with the word "approximately". Here, "approximately" generally means that the actual value is within plus or minus 10%, 5%, 1%, or 0.5% of a specific value or range.

[0053] The composition provided by the present invention, by weight, is prepared from two or more of the following components:

[0054] It is made from at least two of the following raw materials:

[0055] The composition consists of 2-10 parts of lutein ester, 0.1-1 parts of compound vitamins (vitamins A, B1, B2, D, E), 0.01-0.5 parts of zinc-selenium composition, and 5-15 parts of peptide composition.

[0056] In the lutein ester composition, the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin, and cyclodextrin is 1.2:0.2:0.2:0.05:4.95, and the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996.

[0057] The lutein ester composition is prepared from the following raw materials in parts by weight:

[0058] 0.5 to 2.5 parts lutein ester, 0.05 to 0.5 parts lutein, 0.05 to 0.5 parts zeaxanthin, 0.01 to 0.2 parts racemic zeaxanthin, 1 to 5 parts α-cyclodextrin, 1 to 5 parts β-cyclodextrin.

[0059] The zinc-selenium composition is prepared from the following raw materials in parts by weight:

[0060] Zinc glycinate 0.01 to 0.3 parts, selenium-enriched protein powder 0.01 to 0.3 parts;

[0061] The compound vitamins are prepared from the following raw materials in parts by weight:

[0062] Vitamin A 0.0005 to 0.1 parts, Vitamin E 0.001 to 0.05 parts, Vitamin D 0.000001 to 0.00001 parts, Vitamin B1 0.001 to 0.01 parts, Vitamin B2 0.001 to 0.01 parts, Maltodextrin 0.01 to 1 part.

[0063] In this invention, the lutein ester composition comprises lutein ester, lutein, zeaxanthin, and racemic zeaxanthin. Each component is scientifically formulated and its proportions optimized, resulting in excellent multi-antioxidant, blue light protection, and prevention of macular degeneration effects. Lutein and lutein ester form lutein, playing the primary role, while zeaxanthin and racemic zeaxanthin further enhance its effects in preventing eye diseases and slowing vision decline. Furthermore, the lutein ester composition can be used in combination with zinc-selenium compositions, peptide compositions, and compound vitamins to produce synergistic effects.

[0064] In this invention, the "parts" represent the same quality in the same scenario.

[0065] In some embodiments, the composition is prepared from the following parts by weight of raw materials:

[0066] The composition consists of 2-10 parts of lutein ester, 0.1-1 parts of compound vitamins (vitamins A, B1, B2, D, and E), 0.01-0.5 parts of zinc-selenium composition, and 5-15 parts of peptide composition.

[0067] In some specific embodiments, the composition is prepared from the following parts by weight of raw materials:

[0068] The compound contains 0.5 parts of vitamin compound, 6.6 parts of lutein ester composition, 0.1 parts of zinc selenium composition, and 9 parts of peptide composition. The lutein ester composition is prepared by mass ratio of 1.2 parts lutein ester, 0.2 parts lutein, 0.2 parts zeaxanthin, 0.05 parts racemic zeaxanthin, and 4.95 parts cyclodextrin.

[0069] The lutein ester composition of the present invention is prepared by three methods: dry grinding, wet grinding and solvent extraction. The compositions obtained by the three methods all have good inclusion rates, stable properties and effects in preventing eye diseases and slowing down vision decline.

[0070] The dry grinding method specifically includes: mixing lutein esters, lutein, racemic zeaxanthin, zeaxanthin, and cyclodextrin, and grinding them in a ball mill to obtain an inclusion composition.

[0071] In this method, the cyclodextrin is α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin, or hydroxyβ-cyclodextrin. This invention uses a 6:4 mixture of α-cyclodextrin and β-cyclodextrin as the inclusion material. Preferably, the method includes: grinding lutein ester, lutein, zeaxanthin, and racemic zeaxanthin in a ball mill at three times their mass as the inclusion material for 2 hours to obtain a lutein ester composition.

[0072] The wet grinding method specifically includes: mixing lutein ester, lutein, racemic zeaxanthin, zeaxanthin and cyclodextrin, wetting with 50%~80% v / v ethanol aqueous solution, grinding in a ball mill to obtain inclusion complex, and drying and pulverizing to obtain lutein ester inclusion complex.

[0073] In this method, lutein ester, lutein, racemic zeaxanthin, zeaxanthin and cyclodextrin are mixed in a ball mill, 1.2 times the amount of 75% v / v ethanol is added, and after grinding for 2 hours, the mixture is dried and pulverized into a 100-mesh fine powder lutein ester complex.

[0074] The solvent method includes: mixing lutein ester, lutein, racemic zeaxanthin, zeaxanthin and cyclodextrin, adding them to alcohol, and then refluxing, freezing, filtering, drying and pulverizing to obtain the lutein ester composition.

[0075] In this method, lutein ester, lutein, racemic zeaxanthin, zeaxanthin and cyclodextrin are mixed and heated under reflux for 2 hours with 3 times the mass of 75% v / v ethanol, then frozen at 0°C for 8 hours and filtered. The filter cake is dried at 60°C, pulverized and passed through a 100-mesh sieve to obtain the lutein ester composition.

[0076] This invention attempts to combine zinc-selenium compositions, lutein ester compositions, compound vitamin and peptide compositions in pairs, or in threes, or in all fours. It has been found that the combined use of each component is more effective than the use of each component alone, and that a significant synergistic effect can be produced under specific ratios.

[0077] For example:

[0078] The present invention has found that the following compositions all have synergistic effects, as detailed below:

[0079] The zinc-selenium combination and the compound vitamins can produce a synergistic effect at a ratio of 0.1:0.5.

[0080] The lutein ester composition and the peptide composition can produce a synergistic effect in a ratio of 6.6:9.

[0081] The lutein ester composition and the zinc selenium composition can produce a synergistic effect at a ratio of 6.6:0.1.

[0082] The zinc-selenium composition and the peptide composition can produce a synergistic effect at a ratio of 0.1:9.

[0083] The lutein ester composition and the compound vitamins can produce a synergistic effect at a ratio of 6.6:0.5.

[0084] A combination of vitamins and peptides in a 0.5:9 ratio can produce a synergistic effect.

[0085] Therefore, the compositions provided by the present invention are composed of a zinc-selenium composition and a compound vitamin, or a lutein ester composition and a peptide composition, or a peptide composition and a zinc-selenium composition, or a zinc-selenium composition and a lutein ester composition, or a compound vitamin and a lutein ester composition, or a compound vitamin and a peptide composition.

[0086] Alternatively, the composition provided by the present invention may consist of any three of the following: a zinc-selenium composition, a lutein ester composition, a compound vitamin, and a peptide composition. For example, it may consist of a zinc-selenium composition, a peptide composition, and a lutein ester composition; or it may consist of a peptide composition, a compound vitamin, and a lutein ester composition; or it may consist of a zinc-selenium composition, a compound vitamin, and a lutein ester composition; or it may consist of a zinc-selenium composition, a peptide composition, and a compound vitamin.

[0087] Alternatively, the composition provided by the present invention comprises a zinc-selenium composition, a peptide composition, a compound vitamin, and a lutein ester composition.

[0088] In some specific embodiments, the composition comprises the following components in parts by weight:

[0089] The compound contains 0.5 parts of vitamin compound, 9 parts of peptide composition, 0.1 parts of zinc-selenium composition, and 6.6 parts of lutein ester composition.

[0090] In this invention, the lutein ester composition is prepared from raw materials in the following mass ratio: the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin, and cyclodextrin is 1.2:0.2:0.2:0.05:4.95, that is, 6.6 parts of the composition prepared according to the mass ratio of 1.2 parts of lutein ester, 0.2 parts of lutein, 0.2 parts of zeaxanthin, 0.05 parts of racemic zeaxanthin, and 4.95 parts of cyclodextrin.

[0091] In the zinc-selenium composition, the mass ratio of each raw material is: selenium-enriched protein powder: zinc glycine = 0.05: 0.05.

[0092] The mass ratio of each ingredient in the compound vitamin is as follows: the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996.

[0093] In the peptide composition, the mass ratio of each raw material is: blueberry extract: blueberry peptide: goji berry peptide = 8:0.5:0.5.

[0094] Furthermore, the present invention provides the use of the composition as described above in the preparation of a product containing a composition that has the effect of preventing eye diseases and slowing down vision decline.

[0095] In this invention, the effects of preventing eye diseases and slowing down vision decline include preventing macular degeneration and slowing down vision decline.

[0096] Furthermore, the present invention also provides a product for preventing eye diseases and slowing down vision decline, comprising excipients and the composition as described above.

[0097] In this embodiment of the invention, the product for preventing eye diseases and slowing down vision decline has a mass fraction of 3-12% as described above, preferably 5-8%. Specifically, it can be 5.4%, 6.48%, or 7.2%.

[0098] The dosage forms of the products described in this invention are tablets, capsules, granules, powders, oral liquids, soft capsules, pills, ointments, teas, wines, beverages, chewable tablets, lozenges, effervescent tablets, drops, syrups, or powders.

[0099] In some embodiments of the present invention, the excipients include, but are not limited to, at least one of sweeteners, flavoring agents, and antioxidants. Other types of excipients may be added appropriately as needed.

[0100] Preferably, the sweetener is selected from at least one of glucose, white sugar, sucralose, fructose, maltose, lactose, xylitol, sorbitol, maltitol, mannitol, erythritol, steviol glycosides, mogrosides, aspartame, acesulfame potassium, neotame, alitame, isomaltulose, sematose, or ammonium glycyrrhizate.

[0101] Preferably, the flavoring agent is selected from at least one of acerola cherry powder, sweet orange powder, strawberry powder, lemon powder, apple powder, banana powder, instant coffee powder, peppermint flavoring, sweet orange flavoring, citric acid, sodium citrate, L-malic acid, or tartaric acid.

[0102] Preferably, the antioxidant is selected from at least one of natural or biosynthetic vitamin C and its derivatives, natural or synthetic vitamin E and its derivatives, β-carotene and its derivatives, lycopene, anthocyanins, astaxanthin micropowder, coenzyme Q10, and glutathione.

[0103] In some implementation schemes, the excipients are included in specific embodiments, such as isomaltulose, acerola cherry powder, instant coffee powder, vitamin C, and natural vitamins.

[0104] More specifically, the product is made from the following parts by weight of raw materials:

[0105] Erythritol 220.8 parts, Vitamin C 4 parts, Citric acid 5 parts, Flavor 2.5 parts, Blueberry extract 8 parts, Lutein 0.02 parts, Lutein ester 1.2 parts, Zeaxanthin 0.02 parts, Racemic zeaxanthin 0.05 parts, Vitamin A 0.002 parts, Vitamin B1 0.004 parts, Vitamin B2 0.004 parts, Vitamin D 0.000004 parts, Vitamin E 0.03 parts, Maltodextrin 0.459996 parts, Zinc glycine 0.05 parts, Selenium-enriched protein powder 0.05 parts, Blueberry extract 8 parts, Blueberry peptide 0.5 parts, Goji berry peptide 0.5 parts, β-cyclodextrin 1.98 parts, α-cyclodextrin 2.97 parts, and Monk fruit glycoside 1.5 parts.

[0106] Furthermore, the method for preparing the composition of the present invention includes:

[0107] S1. Thoroughly sieve zinc glycinate and selenium-enriched protein powder, mix well, and obtain a zinc-selenium composition.

[0108] S2. Thoroughly sieve vitamin A, vitamin B1, vitamin B2, vitamin D, vitamin E, and maltodextrin, mix them evenly, and obtain a compound vitamin;

[0109] S3. Thoroughly sieve and mix blueberry extract, blueberry peptide, and goji berry peptide to obtain a peptide composition.

[0110] S4. After mixing and sieving the antioxidant, flavoring agent, sweetener and lutein ester composition, mix with the peptide composition, compound vitamin, zinc selenium composition and lutein ester composition, granulate and dry.

[0111] In steps S1 to S4 of this invention, the sieving is performed through a 100-mesh sieve. The number of sieving operations is 2 to 4 times, specifically 2, 3, or 4 times.

[0112] In this invention, the drying process includes drying the granules obtained from granulation under both non-heating and heated conditions. The non-heating drying time is 15-20 minutes, specifically 15 minutes, 18 minutes, or 20 minutes. The heated drying time is 60-120 minutes, specifically 60 minutes, 90 minutes, 100 minutes, or 120 minutes.

[0113] In this invention, the drying process further includes a step of drying the dried particles to a moisture content of ≤5.0%. The drying temperature is 55~65℃, specifically 55℃, 60℃, or 65℃. The drying time is 1~2 hours.

[0114] In some embodiments of the present invention, the drying process further includes sieving and filling the dried granules. The sieving is performed through an 18-mesh sieve.

[0115] In some specific embodiments, the preparation method of the composition of the present invention includes the following steps:

[0116] Zinc glycinate and selenium-enriched protein powder are sieved through a 100-mesh sieve three times and mixed evenly to form a zinc-selenium composition. Vitamin A, vitamin B1, vitamin B2, vitamin D, vitamin E, and maltodextrin are mixed and sieved through a 100-mesh sieve three times and mixed evenly to form a compound vitamin. Blueberry extract, blueberry peptide, and goji berry peptide are mixed and sieved through a 100-mesh sieve three times and mixed evenly to form a peptide composition.

[0117] The zinc-selenium composition, lutein ester composition, peptide composition, and compound vitamins are mixed evenly and passed through a 100-mesh sieve three times. Then, antioxidants, flavoring agents, and sweeteners are mixed evenly using an equal-incrementing method. The mixture is then placed in a high-speed mixing granulator for granulation. The granules are dried in a fluidized bed dryer without heating for 15-20 minutes, and then dried in a drying oven at 55-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0118] Furthermore, the present invention also provides a method for preventing eye diseases and slowing down vision decline, which includes administering the composition or product as described above.

[0119] In this invention, the object to which the substance is given includes humans or mammals, and the mammals include bovines, equines, sheep, pigs, canines, felines, rodents, and primates.

[0120] This invention combines zinc-selenium compositions, compound vitamins, peptide compositions, and lutein ester compositions in pairs, in threes, or in all fours, to produce a synergistic effect under specific ratios. The components of this composition are derived from ingredients that are both medicinal and edible, possessing multiple functions in preventing macular degeneration, aiding weight loss, and mitigating vision decline. It also has a good taste, high compliance, and good effects in combating oxidation, protecting against blue light damage, and improving symptoms of macular degeneration.

[0121] The compositions of the present invention include:

[0122] Erythritol 220.8 parts, Vitamin C 4 parts, Citric acid 5 parts, Flavor 2.5 parts, Blueberry extract 8 parts, Lutein 0.02 parts, Lutein ester 1.2 parts, Zeaxanthin 0.02 parts, Racemic zeaxanthin 0.05 parts, Vitamin A 0.002 parts, Vitamin B1 0.004 parts, Vitamin B2 0.004 parts, Vitamin D 0.000004 parts, Vitamin E 0.03 parts, Maltodextrin 0.459996 parts, Zinc glycine 0.05 parts, Selenium-enriched protein powder 0.05 parts, Blueberry peptide 0.5 parts, Goji berry peptide 0.5 parts, β-cyclodextrin 1.98 parts, α-cyclodextrin 2.97 parts, Monk fruit glycoside 1.5 parts;

[0123] The compound contains 0.5 parts of vitamin compound, 9 parts of peptide composition, 0.1 parts of zinc-selenium composition, and 6.6 parts of lutein ester composition.

[0124] In this invention, the carotenoid complex is a lutein ester composition; the vitamin complex is a compound vitamin; the mineral complex is a zinc-selenium composition; and the plant active complex is a peptide composition.

[0125] The male rats used in this invention were purchased from Shanghai Yisen Biotechnology Co., Ltd.

[0126] The blueberry extract, blueberry peptide, and goji berry peptide of this invention were purchased from: Shaanxi Sinote Biotechnology Co., Ltd.; zinc glycine was purchased from: Hebei Donghua Jinlong Chemical Co., Ltd.; and selenium-enriched protein powder was purchased from: Zhuhai Tianxiangyuan Biotechnology Development Co., Ltd.

[0127] The lutein ester DHA algal oil powder produced by Bayer Plan (Xiamen) Biopharmaceutical Co., Ltd., with batch number 20250122, has the same lutein ester content as the present invention.

[0128] In Examples 1 to 12, Comparative Examples 1 to 4, and Verification Examples 1 to 3 of the present invention, the raw materials and reagents used can all be purchased from the market.

[0129] The present invention will be further illustrated below with reference to the embodiments:

[0130] Example 1

[0131] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate and 0.5 parts selenium-enriched protein powder) and 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, and 0.5 parts goji berry peptide).

[0132] The preparation method includes the following steps:

[0133] Erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, zinc-selenium composition, and peptide composition are passed through a 100-mesh stainless steel sieve three times, mixed and granulated in a high-speed mixing granulator, and the granules are dried in a fluidized bed dryer for 15-20 minutes without heating, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0134] Example 2

[0135] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2 and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996), and 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, and 0.5 parts goji berry peptide).

[0136] The preparation method includes the following steps:

[0137] Erythritol, vitamin C, citric acid, sweet orange flavor, mogrosides, peptide composition, and compound vitamins are passed through a 100-mesh stainless steel sieve three times, mixed and granulated in a high-speed mixing granulator, and the granules are dried in a fluidized bed dryer for 15-20 minutes without heating, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0138] Example 3

[0139] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 0.1 parts zinc-selenium composition (0.05 parts glycine, 0.5 parts selenium-enriched protein), and 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996).

[0140] The preparation method includes the following steps:

[0141] Erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, zinc-selenium combination, and compound vitamins are passed through a 100-mesh stainless steel sieve three times and then mixed and granulated in a high-speed mixing granulator. The granules are dried in a fluidized bed dryer without heating for 15-20 minutes, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0142] Example 4

[0143] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996), and 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin, and cyclodextrin is 1.2:0.2:0.2:0.05:4.95).

[0144] The preparation method includes the following steps

[0145] Step 1: Same as Comparative Example 1;

[0146] Step 2: Pass the erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, compound vitamins, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, and then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0147] Example 5

[0148] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts goji berry peptide) and 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin and cyclodextrin is 1.2:0.2:0.2:0.05:4.95).

[0149] The preparation method includes the following steps:

[0150] Step 1: Same as Comparative Example 1;

[0151] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, peptide composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0152] Example 6

[0153] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin and cyclodextrin is 1.2:0.2:0.2:0.05:4.95) and 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate and 0.05 parts selenium-enriched protein powder).

[0154] The preparation method includes the following steps:

[0155] Step 1: Same as Comparative Example 1;

[0156] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, zinc-selenium composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0157] Example 7

[0158] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin and cyclodextrin is 1.2:0.2:0.2:0.05:4.95), 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts goji berry peptide), and 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2 and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996).

[0159] The preparation method includes the following steps:

[0160] Step 1: Same as Comparative Example 1;

[0161] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, compound vitamins, peptide composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0162] Example 8

[0163] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin and cyclodextrin is 1.2:0.2:0.2:0.05:4.95), 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts wolfberry peptide), and 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate, 0.5 parts selenium-enriched protein powder).

[0164] The preparation method includes the following steps:

[0165] Step 1: Same as Comparative Example 1;

[0166] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, zinc-selenium composition, peptide composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0167] Example 9

[0168] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts goji berry peptide), 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate, 0.5 parts selenium-enriched protein powder), and 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996).

[0169] The preparation method includes the following steps:

[0170] Erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, compound vitamins, peptide composition, and zinc-selenium composition are passed through a 100-mesh stainless steel sieve three times, mixed and granulated in a high-speed mixing granulator, and the granules are dried in a fluidized bed dryer without heating for 15-20 minutes, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0171] Example 10

[0172] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts goji berry peptide), 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate, 0.5 parts selenium-enriched protein powder), 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996), and 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin, and cyclodextrin is 1.2:0.2:0.2:0.05:4.95).

[0173] The preparation method includes the following steps:

[0174] Step 1: Same as Comparative Example 1;

[0175] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, compound vitamins, zinc-selenium composition, peptide composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0176] Example 11

[0177] The prescription is the same as in Example 10.

[0178] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts goji berry peptide), 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate, 0.5 parts selenium-enriched protein powder), 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996), and 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin, and cyclodextrin is 1.2:0.2:0.2:0.05:4.95).

[0179] The preparation method includes the following steps:

[0180] Step 1: Lutein ester, lutein, racemic zeaxanthin, zeaxanthin, and cyclodextrin are mixed and moistened with a 50%–80% v / v ethanol aqueous solution. The mixture is then ground in a ball mill to obtain an inclusion complex, which is subsequently dried and pulverized to obtain the lutein ester inclusion complex. In this method, lutein ester, lutein, racemic zeaxanthin, zeaxanthin, and cyclodextrin are mixed in a ball mill, 1.2 times the amount of 75% v / v ethanol is added, and after grinding for 2 hours, the mixture is dried and pulverized into a 100-mesh fine powder of the lutein ester composition.

[0181] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, compound vitamins, zinc-selenium composition, peptide composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0182] Example 12

[0183] The prescription is the same as in Example 10.

[0184] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, 0.5 parts goji berry peptide), 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate, 0.5 parts selenium-enriched protein powder), 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996), and 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin, and cyclodextrin is 1.2:0.2:0.2:0.05:4.95).

[0185] The preparation method includes the following steps:

[0186] Step 1 (Solvent Method): Lutein ester, lutein, racemic zeaxanthin, zeaxanthin, and cyclodextrin are mixed and added to alcohol. After reflux, freezing, filtration, drying, and pulverization, the lutein ester composition is obtained. In this method, lutein ester, lutein, racemic zeaxanthin, zeaxanthin, and cyclodextrin are mixed and refluxed with 3 times their mass of 75% v / v ethanol for 2 hours, then frozen at 0°C for 8 hours, filtered, and the filter cake is dried at 60°C, pulverized, and passed through a 100-mesh sieve to obtain the lutein ester composition.

[0187] Step 2: Pass erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, compound vitamins, zinc-selenium composition, peptide composition, and lutein ester composition through a 100-mesh stainless steel sieve three times, then mix and granulate them in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0188] Comparative Example 1

[0189] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, and 6.6 parts lutein ester composition (the mass ratio of lutein ester, lutein, zeaxanthin, racemic zeaxanthin and cyclodextrin is 1.2:0.2:0.2:0.05:4.95).

[0190] The preparation method includes the following steps:

[0191] Step 1: Lutein ester, lutein, zeaxanthin, and racemic zeaxanthin were mixed with 3 times their mass of cyclodextrin as inclusion material and ground in a ball mill for 2 hours to obtain the lutein ester composition.

[0192] Step 2: Pass the combination of erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, and lutein ester through a 100-mesh stainless steel sieve three times, then mix and granulate it in a high-speed mixing granulator. Dry the granules in a fluidized bed dryer without heating for 15-20 minutes, and then dry them in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. After drying, pass the granules through an 18-mesh sieve and then fill them into containers.

[0193] Comparative Example 2

[0194] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, and 0.5 parts compound vitamins (the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and maltodextrin is 0.002:0.000004:0.03:0.004:0.004:0.459996).

[0195] The preparation method includes the following steps:

[0196] Erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, and compound vitamins are passed through a 100-mesh stainless steel sieve three times and then mixed and granulated in a high-speed mixing granulator. The granules are dried in a fluidized bed dryer without heating for 15-20 minutes, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0197] Comparative Example 3

[0198] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts monk fruit glycosides, and 9 parts peptide composition (8 parts blueberry extract, 0.5 parts blueberry peptide, and 0.5 parts goji berry peptide).

[0199] The preparation method includes the following steps:

[0200] Erythritol, vitamin C, citric acid, sweet orange flavor, mogrosides, and peptides are sieved through a 100-mesh stainless steel sieve three times, then mixed and granulated in a high-speed mixing granulator. The granules are dried in a fluidized bed dryer without heating for 15-20 minutes, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then sieved through an 18-mesh sieve and packaged.

[0201] Comparative Example 4

[0202] The prescription is as follows: 220.8 parts erythritol, 4 parts vitamin C, 5 parts citric acid, 2.5 parts sweet orange flavoring, 1.5 parts mogroside, and 0.1 parts zinc-selenium composition (0.05 parts zinc glycinate and 0.5 parts selenium-enriched protein powder).

[0203] The preparation method includes the following steps:

[0204] Erythritol, vitamin C, citric acid, sweet orange flavor, mogroside, and zinc selenium composition are passed through a 100-mesh stainless steel sieve three times, mixed and granulated in a high-speed mixing granulator, and the granules are dried in a fluidized bed dryer for 15-20 minutes without heating, and then dried in a drying oven at 50-65℃ for 1-2 hours until the moisture content is ≤5.0%. The dried granules are then passed through an 18-mesh sieve and packaged.

[0205] Verification Example 1: Animal Experiment

[0206] The efficacy of the compositions described in the previous examples or comparative examples was verified in two parts: animal experiments and human experiments.

[0207] 1. Laboratory animals

[0208] 1.1 Two hundred and seventy male Kunming rats weighing 150-170g were used for the verification. They were randomly divided into groups of 15 rats each.

[0209] Animal model preparation: Kunming male rats were randomly divided into normal group, model group, and experimental group using a random number table. Except for the normal group, the rats in the other groups were injected subcutaneously into the neck and back of the neck with 1.5 g / kg of D-galactose daily at a dose of 0.1 mL / 10 g to establish a D-galactose-induced aging model. (Referring to the method described in the reference "Study on the Improvement of Antioxidant Function of Lutein in Aged Rats" by Pei Lingpeng, Hui Bodi, and Dong Fuhui).

[0210] 1.2 Biochemical index determination

[0211] Determination of malondialdehyde (MDA) content: Thiobarbituric acid (TBA) colorimetric method;

[0212] Method for determining superoxide dismutase (SOD) activity: nitrite method;

[0213] Method for determining glutathione peroxidase (GSH-Px) activity: 5,5-dithio-p-nitrobenzoic acid (DTNB) colorimetric method.

[0214] 1.3 Experimental Grouping

[0215] After successful modeling, the experimental groups were given the products of Examples 1-12 and Comparative Examples 1-4, respectively. One bag of product was dissolved in 60mL of warm water, weighed regularly every day, and administered by gavage at a dose of 1mL / 100g / d, twice a day, for a total of 5 months. The normal group and the model group were fed normally.

[0216] 1.4 Experimental Results

[0217] The serum malondialdehyde (MDA) content and serum superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities of mice in each group were measured.

[0218] Table 1 Zinc-Selenium Compositions and Peptide Compositions

[0219]

[0220] Table 2. Compound Vitamin and Peptide Combinations

[0221]

[0222] Table 3 Zinc-Selenium Combinations and Compound Vitamins

[0223]

[0224] Table 4. Compound Vitamin and Lutein Ester Compositions

[0225]

[0226] Table 5. Lutein ester composition and peptide composition group

[0227]

[0228] Table 6. Lutein ester composition group and zinc selenium composition

[0229]

[0230] Table 7. Examples 10, 2, and 6

[0231]

[0232] Note: In Tables 1-7, ↑ indicates that the level has increased relative to the post-use level, and ↓ indicates that the level has decreased relative to the post-use level.

[0233] The results showed that all groups of test substances had varying degrees of antioxidant capacity. The product group of Example 10 showed the best effect.

[0234] 1.5. Evaluate the interaction effects between the test substances:

[0235] Based on the article "Evaluation of Research Methods for Measuring the Effects of Combined Drug Use" by Guo Jianyou, Huo Hairu, and Jiang Tingliang, which discusses methods for evaluating the effects of combined drug use, including simple algebraic and additive methods and isoline methods, this invention uses simple algebraic and additive methods for evaluation as follows:

[0236] Simple algebraic sum addition method: E A+B =E A +E B ;

[0237] Among them, E A E is the effect produced by drug A when used alone at a certain dosage. B This represents the effect of drug B when used alone at a certain dose. When drugs A and B are used together at their respective individual doses, the combined effect is the algebraic sum of their individual effects. This can be transformed into the formula for determining the combined effect: q = (E... A+B -E A ) / E B But E is required A =E B To avoid E A E B The q-value changes significantly upon interchange. The meaning of the q-value is as follows: q=1 indicates an additive effect, q>1 indicates a synergistic effect, and q<1 indicates an antagonistic effect.

[0238] Table 8

[0239]

[0240] Experimental results show that each component in the composition provided by this invention is indispensable and works together to achieve a good synergistic effect. Furthermore, it has been verified that regardless of the grouping method, the q-value of each group is greater than 1, demonstrating a synergistic effect.

[0241] Verification Example 2

[0242] 2.1 Kunming male rats were used for verification. They were randomly divided into groups of 8 rats each.

[0243] Animal preparation: Kunming male rats were randomly divided into a normal group and a model control group (i.e., experimental group) using a random number table. Except for the normal group, the rats in the other groups were fed a high-fat diet for 6 months, followed by the addition of 0.8% hydroquinone to their drinking water for another 3 months to establish the macular degeneration model. (Ref. "Establishment of a Hydroquinone-Induced Mouse Model of Age-Related Macular Degeneration" Anna, Chen Qiang, Liang Lina, Zhuang Zengyuan.)

[0244] 2.2 Experimental Grouping:

[0245] After successful modeling, the model control group was given lutein ester DHA algal oil powder (batch number 20250122) produced by Bayer Plan (Xiamen) Biopharmaceutical Co., Ltd., as described in Example 10. One packet of the product was dissolved in 60 mL of warm water, and the product was weighed regularly each day and administered by gavage at a dose of 1 mL / 100 g / d, once daily for 3 months. The normal group and the model group were fed normally.

[0246] 2.3 Experimental results after following the procedures outlined in the literature:

[0247] 2.3.1 General Results: Four experimental animals died: two in the model control group, one in the Example 10 group, and one in the lutein ester DHA algal oil powder group. The rest were normal.

[0248] 2.3.2 Comparison of immunohistochemical results among groups (e.g.) Figure 1 (As shown): Cat B expression: In the model control group, a large number of brown granules were observed throughout the entire retinal layer. In the example group: a moderate amount of brown granules were observed in the inner and middle layers of the retina; the lutein ester DHA algal oil powder group had more brown granules in the inner and middle layers of the retina than the example group; the model control group had a large number of brown granules throughout the entire retinal layer, more than the lutein direct drinking powder group. Among them, the model control group had the most, followed by the lutein direct drinking powder group, and the example group had the fewest.

[0249] Verification Example 3: Human Experiment

[0250] Select patients who meet the clinical diagnostic criteria for myopia, are myopic in both eyes, are willing to accept the treatment plan and be followed up, are 15 years or older and 9 years or older, and exclude patients with pathological myopia with ocular complications; patients with infectious diseases or skin ulcers; patients with serious systemic diseases or other eye diseases; patients with impaired consciousness, cognitive impairment, or mental illness; and patients who are receiving other treatments and have not yet completed their treatment course.

[0251] Judgment criteria: (1) Observe the refractive error of the two groups of myopic patients after treatment. (2) Use the TOPON-KR8900 computer optometry instrument to test the visual acuity of the two groups of myopic patients and observe the changes in visual acuity to determine the efficacy. ① Significant effect criterion: visual acuity improved by more than 2 lines; ② Effective criterion: visual acuity test results showed an increase of 1-2 lines; ③ Ineffective criterion: visual acuity did not change.

[0252] Overall clinical efficacy rate = (45 cases - number of ineffective cases) / 45 cases × 100.00%. Production: Occurrence status.

[0253] Ninety eligible individuals were selected as participants. The participants were randomly divided into two groups: a control group and an experimental group, with 45 participants in each group. Visual acuity was tested in all participants before the experiment.

[0254] The sample from Example 10 in the experimental group was taken once a day, one sachet each time, and vision was tested after 6 months of use.

[0255] The control group took commercially available Bayer Plan (Xiamen) Biopharmaceutical Co., Ltd. Their product, lutein ester DHA algal oil powder (batch number 20250122), contains lutein ester, zeaxanthin, blueberry extract, apple powder, xylitol, citric acid, sodium citrate, and vitamin E. They took one sachet once daily, and their vision was tested after six months of treatment.

[0256] The changes in visual acuity parameters of the participants were statistically analyzed. The results are shown in the table below:

[0257] Table 9 Comparison of treatment outcomes

[0258]

[0259] Experimental results show that the compositions provided in each of Examples 10 of the present invention have a good effect on preventing myopia.

[0260] 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, characterized in that, By weight, it includes: The combination of any two or more of the following: 2-10 parts of carotenoid complex, 0.1-1 part of vitamin complex, 0.01-0.5 parts of mineral complex, and 5-15 parts of plant active complex.

2. The composition according to claim 1, characterized in that, The carotenoid complex comprises: lutein ester, lutein, zeaxanthin, and racemic zeaxanthin; the mass ratio of the lutein ester, lutein, zeaxanthin, and racemic zeaxanthin is 1.2:0.2:0.2:0.

05.

3. The composition according to claim 1 or 2, characterized in that, The vitamin complex comprises vitamin A, vitamin D, vitamin E, vitamin B1, and vitamin B2; the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, and vitamin B2 is 0.002:0.000004:0.03:0.004:0.

004.

4. The composition according to any one of claims 1 to 3, characterized in that, The mineral complex comprises selenium and zinc; the mass ratio of selenium to zinc is 1:

1.

5. The composition according to any one of claims 1 to 4, characterized in that, The plant-active complex comprises: blueberry extract, blueberry peptide, and goji berry peptide; the mass ratio of the blueberry extract, the blueberry peptide, and the goji berry peptide is 16:1:

1.

6. The composition according to any one of claims 1 to 5, characterized in that, Also includes: carrier; The carrier includes one or more of the following: β-cyclodextrin, maltodextrin, hydroxypropyl-β-cyclodextrin, sulfobutyl-β-cyclodextrin, microcrystalline cellulose, and lactose.

7. The composition according to claim 6, characterized in that, By weight, it comprises the following components: 6.6 parts of carotenoid complex, 0.5 parts of vitamin complex, 0.1 parts of mineral complex, and 9 parts of plant active complex; The carotenoid complex comprises: 1.2 parts lutein ester, 0.2 parts lutein, 0.2 parts zeaxanthin, 0.05 parts racemic zeaxanthin, and 4.95 parts cyclodextrin; The vitamin complex comprises: 0.002 parts of vitamin A, 0.004 parts of vitamin B1, 0.004 parts of vitamin B2, 0.000004 parts of vitamin D, 0.03 parts of vitamin E, and 0.459996 parts of maltodextrin; The mineral complex comprises: 0.05 parts zinc glycine and 0.05 parts selenium-enriched protein powder; The plant-active complex comprises: 8 parts blueberry extract, 0.5 parts blueberry peptide, and 0.5 parts goji berry peptide.

8. Use of the composition according to any one of claims 1 to 7 in the preparation of products that reduce oxidative stress levels and / or enhance antioxidant enzyme activity.

9. The application as described in claim 8, characterized in that, The composition has any of the following applications; (a) Reduce the content of malondialdehyde; and / or (b) Increase the activity of superoxide dismutase; and / or (c) Increase the activity of glutathione peroxidase.

10. Use of the composition according to any one of claims 1 to 7 in the preparation of products for preventing eye diseases, slowing down vision decline and / or relieving visual fatigue.

11. The application as described in claim 10, characterized in that, The composition has any of the following applications; (d) Prevention of macular degeneration; and / or (e) Improve pigment density in the macular region of the retina; and / or (f) Reduce pathological damage to the retina caused by blue light and / or strong light exposure.

12. The application as described in any one of claims 8 to 11, characterized in that, The products include one or more of the following: pharmaceuticals, food, special medical foods, health products, functional foods, and dietary supplements.

13. A medicine or health product, characterized in that, include: The composition as described in any one of claims 1 to 7 and acceptable excipients.

14. The drug or health product as described in claim 13, characterized in that, The excipients include one or more of the following: sweeteners, flavoring agents, and antioxidants.

15. The method for preparing the drug or health product as described in claim 13 or 14, characterized in that, The drug or health product is obtained by mixing, granulating, and drying the carotenoid complex, the vitamin complex, the mineral complex, the plant active complex, and the excipients.

Images