Composition for preventing and treating myopia and preparation method thereof

Abstract

The present invention relates to a composition for myopia prevention and treatment, including 3-3.5 parts by weight of bilberry extract, 2-2.5 parts by weight of taurine, 0.2-0.3 parts by weight of L-ergothioneine, a pH regulator and water. In the composition for myopia prevention and treatment, L-ergothioneine can significantly improve the stability of bilberry extract in aqueous solution. L-ergothioneine, taurine and bilberry extract can be matched to remove oxygen free radicals produced by fatigue of extraocular muscles and ciliary muscles, protect retina and eye nerves, promote blood circulation of eyes, increase choroid thickness, improve scleral fiber elasticity, control the length of eye axis, comprehensively prevent and treat myopia, and have a synergistic effect. The composition for myopia prevention and treatment of the present invention has good stability, long shelf life and remarkable myopia prevention and treatment effect.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and in particular relates to a composition for preventing and treating myopia and a preparation method thereof. Background Art

[0002] In modern society, due to the popularity of television and computers and the increasing pressure of work and life, eye diseases such as eye fatigue and myopia are increasing.

[0003] Bilberry is a natural fruit similar to blueberry. Its main function is to prevent blood vessel rupture. It is also known as a capillary repairman, protects the eyes, prevents cancer, and also improves chronic hepatitis B. Its main ingredients are natural rhodopsin and flavonoids. Rhodopsin is the most basic substance for the eyes to produce vision, which can enhance the sensitivity of adapting to darkness and weak light. Flavonoids have the activity of vitamin P and are the best substances to protect blood vessels. The human eye is an organ with a highly sophisticated structure, and its capillaries are most susceptible to damage. Therefore, eating bilberry rich in anthocyanins is very effective in protecting the eyes. Experts believe that bilberry has the effect of protecting eyesight, preventing blindness, glaucoma, cataracts, retinal hemorrhage, improving myopia, diabetic retinopathy, pigmentary retinitis, retinal detachment and night blindness.

[0004] The content of anthocyanin pigments in bilberry fruit is as high as 0.07-3.38%, mainly 15 kinds of anthocyanins formed by the combination of 5 kinds of anthocyanins (delphinidin, cyanidin, primulin, petunigenin, methyl anthocyanin) and 3 kinds of sugars (glucose, galactose, arabinose). In addition, it also contains glucose and fructose; organic acids such as citric acid, quinic acid, malic acid; vitamins such as vitamin C and vitamin B5; trace elements such as iron, potassium, manganese, and dietary fiber, chlorogenic acid, yellow quercetin, and flavonol glycosides of myricetin. Studies have shown that anthocyanin pigments in bilberry can promote the resynthesis of rhodopsin in the retina, enhance human vision, and prevent myopia.

[0005] Taurine has many functions, such as promoting brain and intellectual development, preventing cardiovascular diseases, enhancing human immunity, and protecting the liver. It can be regarded as the core raw material of health food. Taurine can also improve nerve conduction and visual function. If infants and young children lack taurine, retinal dysfunction will occur. For patients who receive long-term intravenous nutrition infusion, if there is no taurine in the infusion, the patient's electroretinogram will change. Only a large dose of taurine can correct this change.

[0006] When the prior art bilberry extract exists in an aqueous solution, it is very easy to undergo direct or indirect oxidation reactions, resulting in changes in the chemical composition, affecting the activity of the active ingredients and the stability of the product. In particular, during the high-temperature sterilization process, the bilberry extract is severely degraded. Therefore, the existing bilberry extract products for improving vision are mostly solid preparations, such as capsules, tablets and granules, which are inconvenient to use and are not suitable for children or other people with dysphagia. Oral liquid has many characteristics such as small dosage, high content of active ingredients, high absorption rate, easy to take, and can also be used as a thirst-quenching beverage, which is more competitive in the market than tablets and capsules. Summary of the invention

[0007] In order to solve the above-mentioned problems, the present invention provides a composition for preventing and treating myopia with good stability and long shelf life and a preparation method thereof.

[0008] A composition for preventing and treating myopia comprises 3-3.5 parts by weight of bilberry extract, 2-2.5 parts by weight of taurine, 0.2-0.3 parts by weight of L-ergothioneine, 6.5-13 parts by weight of a pH regulator and 300-500 parts by weight of water. The pH of the composition for preventing and treating myopia is 7.0-7.5.

[0009] The mass percentage of anthocyanins in the bilberry extract is 25%.

[0010] The pigment contained in bilberry fruit is anthocyanin natural pigment, which is also the most important biologically active ingredient of bilberry. Anthocyanin has poor stability and is easily affected by its own structure, pH, temperature, light, oxygen, food additives, metal ions, solvent system and enzymes. Under natural conditions, anthocyanin usually forms anthocyanin with one or more glucose, rhamnose, galactose, arabinose, etc. through glycosides. Bilberry extract is prone to color changes or structural changes during processing and storage. The researchers of the present invention found that under the condition of a small amount of L-ergothioneine, the anthocyanin in the bilberry extract has higher stability in aqueous solution, and unexpectedly obtained a longer shelf life.

[0011] Ergothioneine is a natural water-soluble amino acid derivative with antioxidant properties and good stability. L-ergothioneine has a planar imidazole ring structure. The nitrogen atom on the imidazole ring can provide additional electron density to the π electrons on the ring through lone pairs of electrons, which has an electron-repelling effect. The basic mother nucleus unit of anthocyanin is 2-phenylbenzopyran, i.e., the anthocyanin motif. Due to its lack of electrons, it has strong reactivity and is easily attacked by active oxygen anions and free electrons, and has a strong electron-withdrawing effect. L-ergothioneine can be conjugated with anthocyanin or anthocyanidin to form a vertically stacked complex, thereby preventing the addition of the hydrophilic core and improving the stability of the bilberry extract. Anthocyanin or anthocyanidin is also prone to self-polymerization in the presence of L-ergothioneine, thereby improving the stability of the bilberry extract.

[0012] L-ergothioneine can help protect the eyes by removing chronic active oxidative free radicals, reducing the production of active oxidative free radicals in cells and inhibiting oxidation-induced epithelial-mesenchymal transition. L-ergothioneine can also provide nutrition to the choroid at the posterior pole of the eye, thicken the choroid, and increase the elasticity of the scleral fibers, thereby effectively controlling the length of the eye axis, thereby preventing and treating myopia and controlling the increase in myopia.

[0013] L-ergothioneine can be obtained by extraction from Pleurotus ostreatus of the Pleurotus genus of the Pleurotus family. L-ergothioneine can also be obtained by extraction and separation from white button mushrooms, small brown mushrooms, portobello mushrooms, king oyster mushrooms, oyster mushrooms, shiitake mushrooms, maitake mushrooms, ganoderma lucidum, hericium erinaceus, shiitake mushrooms, chanterelles, boletus edulis, morels and other mushrooms using methods known in the prior art.

[0014] After oral administration, in the strongly acidic environment of the stomach, the conjugate between anthocyanidins or anthocyanins and L-ergothioneine is easily separated, and each exerts its physiological activity.

[0015] The composition for preventing and treating myopia further comprises 0.5-0.8 parts by weight of tryptophan.

[0016] Tryptophan is an amino acid substance. Tryptophan has an indole planar structure, and a N-containing heterocyclic structure is connected to the benzene ring. The indole ring is an electron-rich system. In acidic aqueous solution, the indole ring and the carbonyl group have strong electron-repelling ability, which can be conjugated with anthocyanidins to form a stable vertically stacked complex structure. Both tryptophan and L-ergothioneine have planar N-containing heterocyclic rings, which can form π-π conjugated systems with two different phenolic hydroxyl groups on anthocyanidins or anthocyanins, respectively. Two different N atoms can stabilize two different phenolic hydroxyl groups, respectively, which enhances the hydrophobicity of the anthocyanidin motif and improves the stability of anthocyanidins or anthocyanins.

[0017] In addition to being used as a stabilizer, tryptophan also plays an important role in the metabolic process of humans and animals. Tryptophan is an important precursor for the production of vitamin PP in the human body. Vitamin PP, also known as vitamin B3, niacin, and nicotinic acid, can promote metabolism and dilate blood vessels. Vitamin PP can promote the metabolism of eye cells, promote the synthesis of neurotransmitters, and increase the excitability of the nervous system, thereby reducing the symptoms of eye fatigue caused by long-term use of the eyes.

[0018] The pH regulators are citric acid, sodium citrate and tartaric acid.

[0019] In order to prevent strong acid from damaging anthocyanidins and anthocyanins in bilberry extract, the present invention uses an organic acid with lower acidity. Citric acid-sodium citrate buffer solution has good pH adjustment performance and high stability. Adding a small amount of tartaric acid to the pH buffer solution system has a co-coloring effect on anthocyanidins and anthocyanins, and can also provide the composition with a richer taste and flavor, which is conducive to improving the refreshing taste of the composition.

[0020] The pH regulator is 2.5-10.2 parts by weight of citric acid, 0.6-8.7 parts by weight of sodium citrate, and 1.8-2.2 parts by weight of tartaric acid.

[0021] The composition for preventing and treating myopia further comprises 2-3.5 parts by weight of Panax notoginseng flower extract, 2-3.5 parts by weight of Lycium barbarum extract and 0.5-1 part by weight of zinc gluconate.

[0022] Panax notoginseng flower extract is derived from the stem and leaf extract of Panax notoginseng flower, a perennial herbaceous plant of the Araliaceae family. It is native to Wenshan Prefecture, Yunnan Province, China. It is sweet and cool in nature, light yellow to brownish yellow in color, bitter and slightly sweet, and has hygroscopic properties. The total saponins in Panax notoginseng flower extract are mainly ginsenoside Rb3 (C 53 H 90 O 22 ) shall not be less than 10%. In the field of medicine, Panax notoginseng flower extract has a variety of pharmacological activities, such as anti-inflammatory, analgesic, liver-protecting, and blood pressure-lowering effects. In the present invention, the active ingredients in Panax notoginseng flower can promote blood circulation, relieve symptoms such as eye congestion and swelling, help improve retinal ischemia, anti-oxidation and inhibit apoptosis. The main component of Panax notoginseng total saponin in Panax notoginseng flower extract can soften the meningeal microvessels, accelerate blood flow, and increase blood flow in the head and eyes. The rich vitamin A in Panax notoginseng flower extract can promote the formation of photosensitive pigments in the eyes, improve vision, and relieve various symptoms caused by visual fatigue.

[0023] The main components of wolfberry extract are Lycium barbarum polysaccharides, betaine, zeaxanthine, carotene and amino acids. The molecular weight of wolfberry polysaccharide is 22-25kD, and it is composed of 6 monosaccharide components: arabinose, glucose, galactose, mannose, xylose and rhamnose. Wolfberry extract has the effect of nourishing the liver and kidney, improving eyesight and improving vision. It is rich in carotene, vitamin A, B1, B2, C and calcium, iron and other essential nutrients for eye health, so it is good at improving eyesight, so it is commonly known as "bright eyes". Wolfberry extract can protect retinal ganglion cells by regulating the activity of microglia, thereby improving retinal light damage, preventing and treating myopia.

[0024] Zinc gluconate is a zinc supplement, and zinc deficiency may lead to hypofunction of the eyelid glands, reduced tear secretion, and induce dry eye syndrome. Appropriate use of zinc gluconate can supplement the trace elements needed by the body, promote retinal development, prevent and treat myopia, and relieve visual fatigue.

[0025] Bilberry extract, taurine, wolfberry extract, L-ergothioneine, tryptophan, zinc gluconate and Panax notoginseng flower extract have different characteristics of action. When used together, they can remove oxygen free radicals produced by fatigue of the extraocular muscles and ciliary muscles, protect the retina, protect the ocular nerves, promote blood circulation in the eyes, increase the thickness of the choroid, improve the elasticity of the scleral fibers, control the length of the eye axis, and comprehensively prevent and treat myopia, with a synergistic effect.

[0026] Preferably, the composition for preventing and treating myopia comprises 3 parts by weight of bilberry extract, 2.5 parts by weight of taurine, 3 parts by weight of wolfberry extract, 0.2 parts by weight of L-ergothioneine, 0.8 parts by weight of tryptophan, 3 parts by weight of Panax notoginseng flower extract, 0.5 parts by weight of zinc gluconate, 6.5-13 parts by weight of a pH adjuster and 300-500 parts by weight of water.

[0027] A preparation method for a composition for preventing and treating myopia comprises the following steps: (1) adding a formula amount of L-ergothioneine and tryptophan to 30-50 ml of a buffer solution with a pH of 3-5, heating to 30-40°C, stirring until completely dissolved, adding a formula amount of bilberry extract, stirring evenly, and standing at 4-15°C in the dark for 40-90 minutes to obtain an acidic solution; (2) adding a formula amount of taurine, wolfberry extract, zinc gluconate and Panax notoginseng flower extract to 270-450 ml of pure water to dissolve, adding the acidic solution obtained in step (1) and mixing evenly; (3) filtering and removing impurities, and degassing and deoxygenating by a vacuum method to remove oxygen and other gases in the mixed solution; and (4) heating the deoxygenated mixed solution to 121°C, keeping it for 5 seconds, and sterilizing it to obtain a composition for preventing and treating myopia.

[0028] Add the formulated amount of L-ergothioneine and tryptophan to the pH buffer solution, heat it to 30-40°C, and then add the bilberry extract, which increases the molecular movement between L-ergothioneine, tryptophan and anthocyanins or anthocyanins, mixes the three more evenly, and facilitates the conjugation between anthocyanins or anthocyanins and L-ergothioneine and tryptophan. The increase in temperature easily leads to the degradation of anthocyanins or anthocyanins in bilberry extract. Heating L-ergothioneine and tryptophan before adding bilberry extract can avoid the thermal decomposition of bilberry extract as much as possible. When the concentration of bilberry extract in acidic aqueous solution is 6-12%, conjugation polymerization is most likely to occur. The conjugation between anthocyanins or anthocyanins and L-ergothioneine and tryptophan is an exothermic reaction. Under the condition of high concentration of bilberry extract, anthocyanins or anthocyanins and L-ergothioneine and tryptophan are closely arranged under the condition of low temperature of 5-15°C and light-proof, and vertically stacked to form a regular and stable complex. The highly active phenolic hydroxyl group and hydrophilic core on anthocyanidin or anthocyanin have been protected by L-ergothioneine and tryptophan, preventing the addition reaction between the hydrophilic core and water from forming colorless semialdehyde anthocyanidin or chalcone structure. The obtained complex has strong stability, is insensitive to pH reaction, and is not easy to combine with water molecules. The shelf life of the composition for myopia prevention and treatment is greatly extended. Anthocyanidin, L-ergothioneine, and tryptophan mainly rely on π-π conjugation to enhance the intermolecular binding, no chemical changes occur, the chemical properties of each component remain unchanged, and the biological activity of each component will not be affected.

[0029] The present invention adopts a tubular sterilizer, and the sterilization condition is 121°C for 5 seconds, which can completely sterilize the anthocyanin on the basis of achieving a preservation rate of 95%.

[0030] The pH of the buffer solution in step (1) is 3-4.

[0031] The pH of 3-4 is more conducive to the π-π conjugation between anthocyanidins or anthocyanins and L-ergothioneine and tryptophan. The pH of the composition obtained after mixing with a mixed solution of taurine, wolfberry extract, zinc gluconate and Panax notoginseng flower extract is 4-5, and the nutritional components have good storage stability and a long shelf life.

[0032] The invention has the following characteristics: 1. L-ergothioneine and tryptophan can be conjugated with anthocyanidin or anthocyanin, thereby improving the stability of the bilberry extract in the aqueous solution, having good storage stability, and extending the shelf life of the composition for preventing and treating myopia; 2. The bilberry extract, taurine, wolfberry extract, L-ergothioneine, tryptophan and Panax notoginseng flower extract are used in combination to remove oxygen free radicals generated by fatigue of the extraocular muscles and ciliary muscles, promote blood circulation in the eyes, relieve eye fatigue, increase the thickness of the choroid, improve the elasticity of scleral fibers, control the length of the eye axis, comprehensively prevent and treat myopia, and have a synergistic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a line graph of the experimental results of anthocyanin retention rate in the long-term stability experiment of Experimental Example 1 of the present invention.

[0034] Figure 2 It is a bar graph of the experimental results of zebrafish axial length in Experimental Example 2 of the present invention. DETAILED DESCRIPTION

[0035] Preparation of pH buffer solution: prepare 0.1 mol / L citric acid solution, prepare 0.1 mol / L sodium citrate solution, prepare 0.1 mol / L tartaric acid solution, mix different volumes of citric acid solution, sodium citrate solution and tartaric acid solution, measure the pH to obtain different pH buffer solutions. Example 1

[0036] (1) adding 0.2 g of L-ergothioneine to 30 ml of a pH 3 buffer solution, heating to 30° C., stirring until completely dissolved, adding 3 g of bilberry extract, stirring evenly, and standing at 5° C. in the dark for 90 minutes to obtain an acidic solution; (2) adding 2.5 g of taurine to 270 ml of purified water to dissolve, adding the acidic solution obtained in step (1) and mixing evenly; (3) filtering and removing impurities, and then degassing and deoxygenating by a vacuum method to remove oxygen and other gases in the mixed solution; (4) heating the deoxygenated mixed solution to 121° C., maintaining for 5 seconds, and sterilizing to obtain a composition for preventing and treating myopia. Example 2

[0037] (1) adding 0.25 g of L-ergothioneine and 0.8 g of tryptophan to 50 ml of a pH 4 buffer solution, heating to 30° C., stirring until completely dissolved, adding 3 g of bilberry extract, stirring evenly, and standing at 10° C. in the dark for 40 minutes to obtain an acidic solution; (2) adding 2 g of taurine to 450 ml of purified water to dissolve, adding the acidic solution obtained in step (1) and mixing evenly; (3) filtering and removing impurities, and degassing and deoxygenating by a vacuum method to remove oxygen and other gases in the mixed solution; (4) heating the deoxygenated mixed solution to 121° C., maintaining for 5 seconds, and sterilizing to obtain a composition for preventing and treating myopia. Example 3

[0038] (1) adding 0.2 g L-ergothioneine and 0.5 g tryptophan to 40 ml of pH 5 buffer solution, heating to 40° C., stirring until completely dissolved, adding 3.5 g bilberry extract, stirring evenly, and standing at 15° C. in the dark for 60 minutes to obtain an acidic solution; (2) adding 2.5 g taurine, 3.5 g wolfberry extract, 1 g zinc gluconate and 3.5 g Panax notoginseng flower extract to 360 ml of purified water for dissolution, adding the acidic solution obtained in step (1) and mixing evenly; (3) filtering and removing impurities, and degassing and deoxygenating by vacuum method to remove oxygen and other gases in the mixed solution; (4) heating the deoxygenated mixed solution to 121° C., maintaining for 5 seconds, and sterilizing to obtain a composition for preventing and treating myopia. Example 4

[0039] (1) adding 0.3 g of L-ergothioneine and 0.7 g of tryptophan to 40 ml of a pH 5 buffer solution, heating to 35° C., stirring until completely dissolved, adding 3 g of bilberry extract, stirring evenly, and standing at 10° C. in the dark for 50 min to obtain an acidic solution; (2) adding 2.2 g of taurine, 2 g of wolfberry extract, 0.5 g of zinc gluconate and 2 g of Panax notoginseng flower extract to 360 ml of purified water for dissolution, adding the acidic solution obtained in step (1) and mixing evenly; (3) filtering and removing impurities, and degassing and deoxygenating by a vacuum method to remove oxygen and other gases in the mixed solution; (4) heating the deoxygenated mixed solution to 121° C., maintaining for 5 seconds, and sterilizing to obtain a composition for preventing and treating myopia. Example 5

[0040] (1) Add 0.2 g L-ergothioneine and 0.8 g tryptophan to 50 ml pH 3 buffer solution, heat to 35° C., stir until completely dissolved, add 3 g bilberry extract, stir evenly, and stand at 10° C. in the dark for 60 minutes to obtain an acidic solution; (2) Add 2.5 g taurine, 3 g wolfberry extract, 0.5 g zinc gluconate and 3 g Panax notoginseng flower extract to 450 ml pure water to dissolve, add the acidic solution obtained in step (1) and mix evenly; (3) After filtering and removing impurities, vacuum degassing and deoxygenation are performed to remove oxygen and other gases in the mixed solution; (4) The deoxygenated mixed solution is heated to 121° C. and maintained for 5 seconds for sterilization to obtain a composition for the prevention and treatment of myopia. Comparative Example 1

[0041] (1) adding 3 g of bilberry extract to 50 ml of pH 3 buffer solution to obtain an acidic solution; (2) adding 2.5 g of taurine, 3 g of wolfberry extract, 0.5 g of zinc gluconate and 3 g of Panax notoginseng flower extract to 450 ml of purified water to dissolve, adding the acidic solution obtained in step (1) to mix evenly; (3) filtering and removing impurities, and then degassing and deoxygenating by vacuum method to remove oxygen and other gases in the mixed solution; (4) heating the deoxygenated mixed solution to 121° C. and maintaining it for 5 seconds to sterilize to obtain a composition for preventing and treating myopia.

[0042] Experimental Example 1: Evaluation of the stability of bilberry extract

[0043] The myopia prevention and treatment compositions prepared in Examples 1-5 and Comparative Example 1 were placed in sealed strips, 20 ml per strip, and stored at a temperature of 37±2°C, a relative humidity of RH75±5%, and away from direct sunlight for 6 months.

[0044] Anthocyanin was used as the stability evaluation index of bilberry extract, and the dual-wavelength pH differential method was used to determine the anthocyanin content C0 and C1. Cyanidin 3-0-glucoside was used as a reference. Take 5 ml of the test solution, add 20 ml of NaAc-HAc buffer solution (pH 4.5, 0.4 mol / L) and KCl-HCl buffer solution (pH 1.0, 0.25 mol / L), shake well, let it stand for 20 minutes, transfer it to a cuvette with a light path length of 1 cm, use the buffer solution as a blank control, and measure the absorbance at wavelengths of 510 nm and 710 nm, respectively. The anthocyanin content calculation formula is: C (mg / 100g) = ( A × M x DF × V ×100)÷ ε ;in A =( A 510 - A 710 ) pH1.0 -( A 510 - A 710 ) pH4.5； Mw = 449.2 g / mol (Mw is the molar mass of cyanidin 3-0-glucoside); DF is the dilution multiple (5 times); V= 100mL( V is the volume of the composition of the present application after being fixed to volume); ε =26900 mol / (L·cm)( εis the molar extinction coefficient of cyanidin 3-0-glucoside). Anthocyanin retention rate = C1 / C0×100%. The results are shown in Table 1.

[0045] Table 1. Anthocyanin retention rate (%) of the compositions for myopia prevention and treatment prepared in different examples.

[0046]

[0047] It can be seen from Table 1 that the retention rate of anthocyanidins in Examples 1-5 of the present invention is much higher than the retention rate of anthocyanidins without adding L-ergothioneine and tryptophan in Comparative Example 1. It is illustrated that L-ergothioneine and tryptophan can significantly improve the storage stability of anthocyanidins in aqueous solution. It can be seen from the data comparison of Example 1 and Example 2-5 that in Example 2-5, under the condition of the simultaneous presence of L-ergothioneine and tryptophan, the stability of anthocyanidins in aqueous solution is better than that of Example 1 in which L-ergothioneine is added separately.

[0048] Experimental Example 2: Evaluation of myopia prevention and treatment effects using a zebrafish model

[0049] The blood vessel structure of zebrafish eyes is very similar to that of humans, and the structure of zebrafish retina is also highly similar to that of humans, so it is often used as an experimental subject for ophthalmological research. Knocking out the zebrafish (zlum) gene can lead to thinning of the sclera and expansion of its diameter, which is consistent with the characteristics of human high myopia.

[0050] The model control group and Example 1-5 groups adopted the zebrafish lumican (Zlum) gene knockout model, with 10 fish in each group. The zebrafish lumican gene (zlum) morpholino (10ng / 2μl) targeting the zebrafish was microinjected into the single-cell zebrafish embryo to cause excessive expansion of the sclera and obtain the zebrafish lumican (Zlum) gene knockout model. The normal control group adopted healthy zebrafish. The model control group and the normal control group were raised normally. The Example 1-5 groups ingested the composition for myopia prevention and treatment prepared in Example 1-5 of the present invention (the dosage of the composition for myopia prevention and treatment was 60ml / L fish farming water). The rearing conditions were water temperature 25±1℃, 14 hours of light, and 10 hours of darkness. Three-dimensional in vivo continuous imaging monitoring was performed using optical coherence tomography technology on the 7th, 15th, and 30th days after zebrafish microinjection, respectively, to measure the zebrafish eye axis length.

[0051] Table 2 Axial length of zebrafish (Zlum) knockout model (µm).

[0052] Group Day 7 Day 15 Day 30 Normal control group 336.4±15.6 389.8±13.2 781.6±9.3 Model control group 406.3±38.1 468.5±42.8 990.1±56.7 Example 1 Group 397.5±53.2 423.7±39.5 852.4±35.8 Example 2 Group 386.7±28.6 418.4±26.7 839.6±26.2 Example 3 Group 378.8±42.8 402.5±34.8 802.4±32.5 Example 4 Group 382.3±35.6 406.5±35.9 827.7±29.4 Example 5 Group 375.4±39.6 397.7±28.4 798.5±23.7

[0053] From Table 2, Figure 2It can be seen that the axial length of the zebrafish in Examples 1-5 of the present invention is significantly shorter than that in the model control group. On the 30th day, the axial length of the zebrafish was similar to that of the normal control group, indicating that the composition for myopia prevention and treatment prepared in Examples 1-5 of the present invention can prevent the axial expansion caused by the knockout of the zebrafish (zlum) gene and reduce the axial length of the zebrafish (zlum) gene knockout model. It is confirmed that the composition for myopia prevention and treatment of the present invention has the effect of preventing and treating myopia and protecting eyesight.

[0054] Experimental Example 3. Experimental verification of the effect of the composition of the present invention on improving vision

[0055] The test substance is the composition prepared in Examples 1-5 of the present invention. 40 subjects aged 18-35 years with mild myopia symptoms due to long-term eye use were selected on a voluntary basis and randomly divided into Groups 1-5 of Examples. Exclusion criteria: (1) patients with a history of eye lesions, surgery, systemic or nervous system abnormalities; (2) patients with strabismus and amblyopia in the initial optometry examination; (3) patients with abnormal intraocular pressure (intraocular pressure <10 mmHg or intraocular pressure >21 mmHg or intraocular pressure difference between the two eyes >5 mmHg); (4) patients who cannot undergo regular eye examinations; (5) patients who have participated in any myopia control clinical research trials within three months, and have previously used or are currently using hard corneal contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, light feeding devices, low-concentration atropine drugs, etc.; (6) manifest strabismus; the amount of latent strabismus when looking at distance or near is ≥20 prism degrees. The composition for myopia prevention and treatment of Examples 1-5 of the present invention was taken twice a day, 20 ml each time. It was taken for two consecutive months. During the trial period, the subjects stopped taking other drugs or health products related to improving vision. The refractive power and corneal curvature were measured before and after the test, and the left and right eyes were measured three times each, and the average value was taken. The axial length of the eye was checked using an axial measuring instrument, and the left and right eyes were measured 3 times each, and the average value was taken.

[0056] Table 3 Changes in the subjects' average refractive power, corneal curvature and axial length.

[0057] Group Corneal curvature before test D Axial length before test (mm) Refraction before test Corneal curvature after test D Axial length of eye after test (mm) Refraction after test Example 1 Group 44.56±1.42 25.31±1.89 -0.75DS 43.47±1.41 23.84±1.78 -0.50DS Example 2 Group 43.64±1.49 24.90±1.91 -1.50DS 42.79±1.50 24.42±1.37 -0.50DS Example 3 Group 44.58±1.53 25.08±1.86 -1.25DS 43.42±1.47 24.53±1.67 -0.50DS Example 4 Group 43.74±1.41 24.42±1.84 -1.50DS 42.48±1.37 23.78±1.19 -0.50DS Example 5 Group 43.71±1.52 24.84±1.78 -0.75DS 42.50±1.43 24.22±1.42 -0.50DS

[0058] It can be seen from Table 3 that after two months of oral administration of the composition for myopia prevention and treatment of Examples 1-5 of the present invention, the corneal curvature, axial length and diopter of the subjects all returned to normal values, indicating that the present invention has a significant effect of improving vision and preventing and treating myopia.

Claims

1. A composition for preventing and treating myopia, characterized in that: The invention comprises 3-3.5 parts by weight of bilberry extract, 2-2.5 parts by weight of taurine, 0.2-0.3 parts by weight of L-ergothioneine, 6.5-13 parts by weight of a pH regulator and 300-500 parts by weight of water.

2. A composition for preventing and treating myopia according to claim 1, characterized in that: The composition for preventing and treating myopia further comprises 0.5-0.8 parts by weight of tryptophan.

3. A composition for preventing and treating myopia according to claim 2, characterized in that: The pH regulators are citric acid, sodium citrate and tartaric acid.

4. A composition for preventing and treating myopia according to claim 2 or 3, characterized in that: The composition for preventing and treating myopia further comprises 2-3.5 parts by weight of Panax notoginseng flower extract, 2-3.5 parts by weight of Lycium barbarum extract and 0.5-1 part by weight of zinc gluconate.

5. A composition for preventing and treating myopia according to claim 4, characterized in that: The composition for preventing and treating myopia comprises 3 parts by weight of bilberry extract, 2.5 parts by weight of taurine, 3 parts by weight of wolfberry extract, 0.2 parts by weight of L-ergothioneine, 0.8 parts by weight of tryptophan, 3 parts by weight of notoginseng flower extract, 0.5 parts by weight of zinc gluconate, 6.5-13 parts by weight of a pH regulator and 300-500 parts by weight of water.

6. A method for preparing a composition for preventing and treating myopia according to claim 4 or 5, characterized in that: The steps include: (1) adding a formula amount of L-ergothioneine and tryptophan to 30-50 ml of a pH 3-5 buffer solution, heating to 30-40° C., stirring until completely dissolved, adding a formula amount of bilberry extract, stirring evenly, and standing in dark at 4-15° C. for 40-90 min to obtain an acidic solution; (2) Add the formulated amount of taurine, wolfberry extract, zinc gluconate and Panax notoginseng flower extract into 270-450 ml of purified water to dissolve, and add the obtained acidic solution to mix evenly; (3) After filtering and removing impurities, vacuum method is used for degassing and deoxygenation to remove oxygen and other gases in the mixed solution; (4) The deoxygenated mixed solution is heated to 121° C. and maintained for 5 seconds for sterilization to obtain a composition for preventing and treating myopia.

7. The method for preparing a composition for preventing and treating myopia according to claim 6, characterized in that: The pH of the buffer solution is 3-4.

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