Preparation composition for preventing and treating eye diseases and delaying visual decline and preparation method thereof

Abstract

The invention discloses a preparation composition for preventing and treating eye diseases and delaying visual decline and a preparation method thereof. The composition is prepared from fructus lycii, semen cassiae, blueberries, marigold, eyebright, ligusticum wallichii, pseudo-ginseng, roxburgh rose, pleurotus citrinopileatus, bilberry, haematococcus pluvialis, xanthophyll, zeaxanthin, retinol, ergothioneine, beta-carotene, vitamin E, organic selenium, phospholipid DHA, procyanidine, curcumin and lycopene. The composition can prevent and treat eye diseases and delay visual decline. The traditional Chinese medicine composition can relieve asthenopia, can relieve the symptoms of blurred vision, dry eyes, soreness and swelling, pain and the like, and can treat macular degeneration. The composition has no side effect on a human body and is high in safety; injection administration and operation are avoided, no sequelae are left, and the medicine is convenient to take and carry by a patient; the preparation process is simple, the performance is stable and reliable, the production efficiency is high, the cost is low, and the application prospect is wide. The invention further discloses a polypeptide for relieving asthenopia, wherein the sequence of the polypeptide is shown as SEQ ID NO: 1.

Description

Technical Field

[0001] The present invention belongs to the field of biomedicine, and specifically relates to polypeptides, compositions, preparations and preparation methods thereof for preventing and treating eye diseases and delaying vision loss. Background Art

[0002] Visual fatigue, also known as eye fatigue or eye strain, refers to the symptoms of eye fatigue and discomfort caused by prolonged use or excessive load on the eyes. This condition is common when using the eyes at close range for a long time, such as using electronic devices (mobile phones, computers, tablets), reading, driving, etc. Common symptoms of visual fatigue include but are not limited to: sore or dry eyes, blurred vision or temporary vision loss, burning or foreign body sensation in the eyes, headache or neck and shoulder discomfort, eye congestion, tearing or frequent blinking, and light sensitivity.

[0003] The main causes of visual fatigue include but are not limited to: prolonged use of electronic screens; poor lighting; prolonged close-range use of the eyes; bad eye habits; uncorrected refractive errors (myopia, hyperopia, astigmatism), or wearing inappropriate glasses.

[0004] Ways to relieve visual fatigue include but are not limited to: follow the "20-20-20" rule, stare at an object 20 feet away (about 6 meters) for at least 20 seconds every 20 minutes of work; maintain good eye habits, adjust screen brightness, maintain a proper eye distance and posture, and ensure that the working environment has moderate light; regularly rest and relax the eyes, close the eyes, massage the eyes or apply hot compresses; keep the air moist; use artificial tears. However, the effects of these methods are still limited.

[0005] Macular Degeneration (AMD) is an age-related eye disease that primarily affects the macula, an area of ​​the retina, causing a gradual loss of central vision. It is one of the leading causes of blindness in older people. The macula is the area of ​​the retina responsible for sharp central vision, which is essential for daily activities such as reading, driving, and recognizing faces. There are two forms of AMD: dry (the most common and accounting for the majority of cases) and wet (less common, but more severe than the dry form and progresses more quickly). Damage to the macula occurs when abnormal new blood vessels grow under the retina and leak fluid or blood. This often results in rapid vision deterioration, which can occur over months or even weeks.

[0006] Common symptoms of macular degeneration include, but are not limited to: blurred central vision, difficulty seeing details, especially when reading or looking at distant objects; metamorphosis, where straight lines appear curved or distorted; central scotoma, where a dark shadow or blind spot may appear in the center of the field of vision; and changes in color vision, where colors can become difficult to distinguish or contrast is reduced.

[0007] The main risk factors for macular degeneration include but are not limited to: age, the incidence rate is higher in people over 50 years old; family history, people with a family history of macular degeneration are at higher risk; it will significantly increase the risk of disease; obesity and cardiovascular disease, people who are overweight or have cardiovascular disease are also at higher risk; long-term ultraviolet exposure, excessive sunlight exposure may increase the risk of macular degeneration.

[0008] Medical treatments for wet macular degeneration include, but are not limited to: photodynamic therapy, which combines drugs and laser therapy to treat new blood vessels in wet macular degeneration; laser therapy, which can destroy abnormal blood vessels through lasers to prevent further vision damage in some patients with wet macular degeneration. However, the above methods are inconvenient and have limited effects.

[0009] There is an urgent clinical need for drugs to relieve visual fatigue and treat macular degeneration. Summary of the invention

[0010] In one aspect of the present invention, a composition for preventing and treating eye diseases and delaying vision loss is provided, characterized in that the composition comprises the following components in parts by weight: 25-110 parts by weight of wolfberry, 25-95 parts by weight of cassia seed, 10-90 parts by weight of blueberry, 10-95 parts by weight of marigold, 10-90 parts by weight of eyebright grass, 10-90 parts by weight of chuanxiong, 10-90 parts by weight of notoginseng, 20-90 parts by weight of roxburghii, 15-90 parts by weight of pleurotus eryngii, 20-90 parts by weight of bilberry, 20-90 parts by weight of Haematococcus pluvialis, 10-85 parts by weight of lutein, 10-90 parts by weight of zeaxanthin, 10-90 parts by weight of retinol, 20-95 parts by weight of ergothioneine, 25-100 parts by weight of beta-carotene, 20-95 parts by weight of vitamin E, 10-90 parts by weight of organic selenium, 20-90 parts by weight of phospholipid DHA, 15-90 parts by weight of proanthocyanidins, 15-80 parts by weight of curcumin, and 15-95 parts by weight of lycopene.

[0011] In some embodiments of the present invention, the composition comprises the following components in parts by weight: 25-110 parts by weight of wolfberry, 25-95 parts by weight of cassia seed, 10-90 parts by weight of blueberry, 10-95 parts by weight of marigold, 10-90 parts by weight of eyebright grass, 10-90 parts by weight of chuanxiong, 10-90 parts by weight of notoginseng, 20-90 parts by weight of roxburghii, 15-90 parts by weight of golden top pleurotus, 20-90 parts by weight of bilberry, 20-90 parts by weight of Haematococcus pluvialis, 10-85 parts by weight of lutein, 10-90 parts by weight of zeaxanthin, 10-90 parts by weight of retinol, 20-95 parts by weight of ergothioneine, 25-100 parts by weight of beta-carotene, 20-95 parts by weight of vitamin E, 10-90 parts by weight of seleno-L-cysteine, and phospholipid DHA 20-90 parts by weight, proanthocyanidins 15-90 parts by weight, curcumin 15-80 parts by weight, lycopene 15-95 parts by weight.

[0012] In some embodiments of the present invention, the composition comprises the following components in parts by weight: 80 parts by weight of wolfberry, 80 parts by weight of cassia seed, 40 parts by weight of blueberry, 70 parts by weight of marigold, 80 parts by weight of eyebright, 50 parts by weight of chuanxiong, 40 parts by weight of notoginseng, 30 parts by weight of roxburghii, 80 parts by weight of golden top pleurotus, 30 parts by weight of bilberry, 80 parts by weight of Haematococcus pluvialis, 70 parts by weight of lutein, 80 parts by weight of zeaxanthin, 30 parts by weight of retinol, 50 parts by weight of ergothioneine, 30 parts by weight of beta-carotene, 30 parts by weight of vitamin E, 40 parts by weight of seleno-L-cysteine, 30 parts by weight of phospholipid DHA, 80 parts by weight of proanthocyanidins, 30 parts by weight of curcumin, and 30 parts by weight of lycopene.

[0013] In some embodiments of the present invention, the wolfberry is the dried fruit of wolfberry. In some embodiments of the present invention, the cassia seed is the dried mature seeds of cassia. In some embodiments of the present invention, the blueberry is the dried fruit of blueberry. In some embodiments of the present invention, the marigold is the dried leaves. In some embodiments of the present invention, the eyebright is the dried whole grass. In some embodiments of the present invention, the chuanxiong is the dried rhizome. In some embodiments of the present invention, the notoginseng is the dried rhizome. In some embodiments of the present invention, the roxburghii is the dried fruit. In some embodiments of the present invention, the golden top pleurotus is the dried fruiting body. In some embodiments of the present invention, the blueberry is the dried fruit.

[0014] In some embodiments of the present invention, the Haematococcus pluvialis is Haematococcus pluvialis powder. In some embodiments of the present invention, the Haematococcus pluvialis powder is purchased from ZOLANBIO. In some embodiments of the present invention, the lutein is purchased from Shaanxi Yikanglong Biology. In some embodiments of the present invention, the zeaxanthin is purchased from Wuhan Fengtai Weiyuan Technology. In some embodiments of the present invention, the retinol is purchased from Jiangxi Ruiweier Biology. In some embodiments of the present invention, the ergothioneine is purchased from Shenzhen Xijia Biology. In some embodiments of the present invention, the β-carotene is purchased from Sigma. In some embodiments of the present invention, the vitamin E is purchased from Hebei Zhenjia New Materials. In some embodiments of the present invention, the organic selenium is selenocysteine. In some embodiments of the present invention, the organic selenium is seleno-L-cysteine. In some embodiments of the present invention, the seleno-L-cysteine ​​is purchased from Wuhan Inno Pharmaceutical Technology. In some embodiments of the present invention, the CAS number of the phospholipid DHA is 59403-52-0. In some embodiments of the present invention, the phospholipid DHA is purchased from MCE®, catalog number HY-W440983. In some embodiments of the present invention, the proanthocyanidins are purchased from MCE® Proanthocyanidins, catalog number HY-N0794. In some embodiments of the present invention, the curcumin is purchased from Shaanxi Yikanglong Biotechnology. In some embodiments of the present invention, the lycopene is purchased from Nanjing Daosifu Biological.

[0015] In some embodiments of the present invention, the composition is the composition AMX-EYE-01, AMX-EYE-02 or AMX-EYE-03 described in Example 1. In some embodiments of the present invention, the composition is the composition AMX-EYE-03 described in Example 1. In some embodiments of the present invention, the composition comprises 0.01%-0.03% by weight of the polypeptide AMX-EYE-P1. The amino acid sequence of the polypeptide AMX-EYE-P1 is shown in SEQ ID NO: 1.

[0016] In some embodiments of the present invention, the composition is prepared by the method described in Example 1.

[0017] In some embodiments of the present invention, the composition is prepared by the following method: Take 80 grams of wolfberry, 80 grams of cassia seed, 40 grams of blueberry, 70 grams of marigold, 80 grams of eyebright, 50 grams of chuanxiong, 40 grams of panax notoginseng, 30 grams of roxburghii, 80 grams of golden top pleurotus, and 30 grams of bilberry; wash them respectively with water, air-dry at room temperature, and grind them into an average particle size of 500 microns; then mix them evenly with 80 grams of Haematococcus pluvialis, 70 grams of lutein, 80 grams of zeaxanthin, 30 grams of retinol, 50 grams of ergothioneine, 30 grams of β-carotene, 30 grams of vitamin E, 40 grams of seleno-L-cysteine, 30 grams of phospholipid DHA, 80 grams of proanthocyanidins, 30 grams of curcumin and 30 grams of lycopene to obtain the mixture.

[0018] In another aspect of the present invention, a method for preparing a composition for preventing and treating eye diseases and delaying vision loss is provided, characterized in that it comprises the following steps: Take 25-110 parts by weight of wolfberry, 25-95 parts by weight of cassia seed, 10-90 parts by weight of blueberry, 10-95 parts by weight of marigold, 10-90 parts by weight of eyebright, 10-90 parts by weight of chuanxiong, 10-90 parts by weight of notoginseng, 20-90 parts by weight of roxburghii, 15-90 parts by weight of golden top pleurotus, 20-90 parts by weight of bilberry, 20-90 parts by weight of Haematococcus pluvialis, 10-85 parts by weight of lutein, 10-90 parts by weight of zeaxanthin, 10-90 parts by weight of retinol, 20-95 parts by weight of ergothioneine, 25-100 parts by weight of beta-carotene, 20-95 parts by weight of vitamin E, 10-90 parts by weight of seleno-L-cysteine, and phospholipid DHA. 20-90 parts by weight, 15-90 parts by weight of proanthocyanidins, 15-80 parts by weight of curcumin and 15-95 parts by weight of lycopene are uniformly mixed to obtain the product.

[0019] In some embodiments of the present invention, the preparation method comprises the following steps: taking 80 grams of wolfberry, 80 grams of cassia seed, 40 grams of blueberry, 70 grams of marigold, 80 grams of eyebright grass, 50 grams of chuanxiong, 40 grams of Panax notoginseng, 30 grams of roxburghii, 80 grams of Pleurotus eryngii, and 30 grams of bilberry; washing them respectively with water, air-drying at room temperature, and crushing them to an average particle size of 500 microns; then mixing them evenly with 80 grams of Haematococcus pluvialis, 70 grams of lutein, 80 grams of zeaxanthin, 30 grams of retinol, 50 grams of ergothioneine, 30 grams of β-carotene, 30 grams of vitamin E, 40 grams of seleno-L-cysteine, 30 grams of phospholipid DHA, 80 grams of proanthocyanidins, 30 grams of curcumin, and 30 grams of lycopene to obtain the obtained mixture.

[0020] In some specific embodiments of the present invention, the preparation method of the composition is as described in Example 1.

[0021] In some embodiments of the present invention, the method for preparing the composition comprises: The above-mentioned composition is irradiated and sterilized, granulated, dried and sized to obtain granules.

[0022] In some embodiments of the present invention, the method for preparing the composition comprises: The above-mentioned composition is subjected to irradiation sterilization, granulation, drying and granulation to obtain granules; the granules are mixed with pharmaceutically acceptable excipients and then filled into capsule shells or the granules are directly filled into capsule shells to obtain capsules.

[0023] In some embodiments of the present invention, the granulation method is to add 65%-75% ethanol in a volume fraction of 3-6% by weight to the sterilized mixture to make a soft material, and then granulate it through a 10-16 mesh sieve.

[0024] In some embodiments of the present invention, the drying temperature is 50° C.-70° C., and the drying time is 2-4 hours.

[0025] In some embodiments of the present invention, the sterilization is radiation sterilization, and the environment of the radiation sterilization is: cobalt-60 radiation sterilization, and the radiation dose is ≤6 kGy.

[0026] In some embodiments of the present invention, the preparation method of the composition includes: irradiating the aforementioned composition for sterilization, 60Co radiation, and an irradiation dose of 3 kGy; adding 4% of its weight of 70% ethanol (V / V) to the sterilized mixture to make a soft material and then granulate it through a 12-mesh sieve; drying at 55 degrees Celsius for 3 hours; and granulating to obtain granules.

[0027] In some embodiments of the present invention, the preparation method of the composition includes: irradiating the aforementioned composition for sterilization, 60Co radiation, and an irradiation dose of 3 kGy; adding 4% of its weight of 70% ethanol (V / V) to the sterilized mixture to make a soft material and then granulate it through a 12-mesh sieve; drying at 55 degrees Celsius for 3 hours; granulating to obtain composition particles; and loading the composition particles into capsule shells to obtain capsules.

[0028] In some embodiments of the present invention, each capsule shell is filled with 400-800 mg of the composition particles.

[0029] In some embodiments of the present invention, each capsule shell is filled with 500 mg, 600 mg or 750 mg of the composition particles.

[0030] In some embodiments of the present invention, the capsule shell is a hard capsule shell and the capsule is a hard capsule.

[0031] In some embodiments of the present invention, the capsule shell is a soft capsule shell, and the capsule is a soft capsule.

[0032] In another aspect of the present invention, a polypeptide is provided, characterized in that the polypeptide comprises an amino acid sequence as shown in SEQ ID NO: 1 or 2.

[0033] In some embodiments of the present invention, the amino acid sequence of the polypeptide is shown in SEQ ID NO: 1 or 2.

[0034] In some embodiments of the present invention, the amino acid sequence of the polypeptide is shown in SEQ ID NO: 1.

[0035] In another aspect of the present invention, a preparation for preventing and treating eye diseases and delaying vision loss is provided, characterized in that the preparation comprises the composition according to the present invention.

[0036] In some specific embodiments of the present invention, the formulation is a pharmaceutical formulation.

[0037] In some specific embodiments of the present invention, the preparation is an oral dosage form.

[0038] In some specific embodiments of the present invention, the dosage form of the preparation is: capsule, granule, tablet, oral solution or pill.

[0039] In some embodiments of the present invention, the preparation is selected from: hard capsules, soft capsules, granules, tablets.

[0040] In some embodiments of the present invention, the composition described in any one of the present invention is sterilized by irradiation, granulated, dried, and sized to obtain granules.

[0041] In some embodiments of the present invention, the composition described in any one of the present invention is irradiated and sterilized, granulated, dried, and sized to obtain granules; the granules are loaded into capsule shells to obtain capsules.

[0042] In some embodiments of the present invention, the composition described in any one of the present invention is irradiated and sterilized, granulated, dried, and sized to obtain granules; the granules are loaded into soft capsule shells to obtain soft capsules.

[0043] In some embodiments of the present invention, the composition described in any one of the present invention is sterilized by irradiation, excipients are added, and tablets are pressed to prepare tablets.

[0044] In some embodiments of the present invention, the method for preparing the formulation comprises: The above-mentioned composition is subjected to irradiation sterilization, granulation, drying and granulation to obtain granules; the granules are mixed with pharmaceutically acceptable excipients and then filled into capsule shells or the granules are directly filled into capsule shells to obtain capsules.

[0045] In some embodiments of the present invention, the granulation method is to add 65%-75% ethanol in a volume fraction of 3-6% by weight to the sterilized mixture to make a soft material, and then granulate it through a 10-16 mesh sieve.

[0046] In some embodiments of the present invention, the drying temperature is 50° C.-70° C., and the drying time is 2-4 hours.

[0047] In some embodiments of the present invention, the sterilization is radiation sterilization, and the environment of the radiation sterilization is: cobalt-60 radiation sterilization, and the radiation dose is ≤6 kGy.

[0048] In some embodiments of the present invention, the preparation method of the preparation comprises: sterilizing the aforementioned composition by irradiation, 60Co radiation, and an irradiation dose of 3 kGy; adding 4% of its weight of 70% ethanol (V / V) to the sterilized mixture to make a soft material and then granulate it through a 12-mesh sieve; drying at 55 degrees Celsius for 3 hours; and granulating to obtain granules.

[0049] In some embodiments of the present invention, the preparation method of the preparation comprises: sterilizing the aforementioned composition by irradiation, 60Co radiation, and an irradiation dose of 3 kGy; adding 4% of its weight of 70% ethanol (V / V) to the sterilized mixture to make a soft material and then granulate it through a 12-mesh sieve; drying at 55 degrees Celsius for 3 hours; granulating to obtain composition particles; and loading the composition particles into a capsule shell to obtain a capsule.

[0050] In some embodiments of the present invention, each capsule shell is filled with 400-800 mg of the composition particles.

[0051] In some embodiments of the present invention, each capsule shell is filled with 500 mg, 600 mg or 750 mg of the composition particles.

[0052] In some embodiments of the present invention, the capsule shell is a hard capsule shell and the capsule is a hard capsule.

[0053] In some embodiments of the present invention, the capsule shell is a soft capsule shell, and the capsule is a soft capsule.

[0054] In some embodiments of the present invention, the preparation is any preparation as described in Example 7.

[0055] In another aspect of the present invention, provided is the use of the composition, the preparation and the polypeptide of the present invention in the preparation of a drug for relieving visual fatigue or treating macular degeneration.

[0056] In some embodiments of the present invention, there is provided use of the composition, the preparation and the polypeptide of the present invention in the preparation of a drug for relieving visual fatigue or treating macular degeneration.

[0057] In some embodiments of the present invention, use of the composition, the preparation and the polypeptide of the present invention in the preparation of a drug for reducing the thickness of Bruch's membrane is provided.

[0058] In some embodiments of the present invention, there is provided use of the composition, the preparation and the polypeptide of the present invention in the preparation of a medicament for preventing or treating macular degeneration by reducing the thickness of Bruch's membrane.

[0059] In some embodiments of the present invention, there is provided use of the composition, the preparation and the polypeptide of the present invention in the preparation of a drug for treating macular degeneration.

[0060] In some embodiments of the present invention, there is provided use of the composition of the present invention in the preparation of a drug for alleviating visual fatigue.

[0061] In some embodiments of the present invention, there is provided use of the polypeptide of the present invention in the preparation of a drug for alleviating visual fatigue.

[0062] In some embodiments of the present invention, there is provided use of the composition of the present invention in the preparation of a medicament for treating macular degeneration.

[0063] In some embodiments of the present invention, there is provided use of the polypeptide of the present invention in the preparation of a drug for treating macular degeneration.

[0064] The technical effects of the technical solution of the present invention are as follows: The composition, preparation and polypeptide of the present invention can prevent and treat eye diseases and delay vision loss. Specifically, it can relieve visual fatigue, reduce symptoms such as blurred vision, dry eyes, soreness, pain, etc., and treat macular degeneration. It can prevent and treat vision problems such as vision loss, night blindness, floaters, glaucoma, cataracts, etc. caused by macular degeneration, retinitis pigmentosa, and diabetic retinopathy, and can improve vision to the greatest extent.

[0065] The composition of the present invention has reasonable proportions of various components, has no side effects on the human body, is highly safe, and has significant therapeutic effects. The composition of the present invention avoids injection and surgery, does not leave any sequelae, and is convenient for patients to take and carry. The preparation process of the preparation is simple, the performance is stable and reliable, the production efficiency is high, the production cost is low, and it has broad application prospects. DETAILED DESCRIPTION

[0066] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples. The experimental methods in the following examples without specifying specific conditions are selected according to conventional methods and conditions, or according to the product specifications. Unless otherwise specified, the reagents and raw materials used in the present invention are all commercially available. Example

[0067] Take 80 grams of wolfberry (dried fruit of wolfberry), 80 grams of cassia seed (dried mature seeds of cassia), 40 grams of blueberry (dried fruit), 70 grams of marigold (dried leaves), 80 grams of eyebright (dried whole herb), 50 grams of chuanxiong (dried rhizome), 40 grams of panax notoginseng (dried rhizome), 30 grams of roxburghii (dried fruit), 80 grams of pleurotus eryngii (dried fruiting body), and 30 grams of bilberry (dried fruit); wash them respectively with water, air-dry them at room temperature, and crush them to an average particle size of 500 microns; mix them evenly to obtain a solid powder composition AMX-EYE-01.

[0068] Take 80g of Haematococcus pluvialis powder (purchased from ZOLANBIO), 70g of lutein (purchased from Shaanxi Yikanglong Biological), 80g of zeaxanthin (purchased from Wuhan Fengtai Weiyuan Technology), 30g of retinol (purchased from Jiangxi Ruiweier Biological), 50g of ergothioneine (purchased from Shenzhen Xijia Biological), 30g of β-carotene (Sigma), 30g of vitamin E (purchased from Hebei Zhenjia New Materials), 40g of seleno-L-cysteine ​​(purchased from Wuhan Yingnuo Pharmaceutical Technology), 30g of phospholipid DHA (CAS No. 59403-52-0, MCE®, product catalog No. HY-W440983), 30g of proanthocyanidins (MCE® Proanthocyanidins (catalog number HY-N0794) 80 g, curcumin (purchased from Shaanxi Yikanglong Biotechnology) 30 g, lycopene (purchased from Nanjing Daosifu Biology) 30 g; mix well to obtain a solid powder composition AMX-EYE-02.

[0069] Take 80g of wolfberry (dried fruit of wolfberry), 80g of cassia seed (dried mature seeds of cassia), 40g of blueberry (dried fruit), 70g of marigold (dried leaves), 80g of eyebright (dried whole herb), 50g of chuanxiong (dried rhizome), 40g of panax notoginseng (dried rhizome), 30g of roxburghii (dried fruit), 80g of golden top pleurotus (dried fruiting body), and 30g of bilberry (dried fruit); wash them with water, air-dry them at room temperature, and grind them into an average particle size of 500 μm; then mix them with 80g of Haematococcus pluvialis powder (purchased from ZOLANBIO), 80g of leaves, and 100g of celery. 70 g of flavin (purchased from Shaanxi Yikanglong Biological), 80 g of zeaxanthin (purchased from Wuhan Fengtai Weiyuan Technology), 30 g of retinol (purchased from Jiangxi Ruiweier Biological), 50 g of ergothioneine (purchased from Shenzhen Xijia Biological), 30 g of β-carotene (Sigma), 30 g of vitamin E (purchased from Hebei Zhenjia New Materials), 40 g of seleno-L-cysteine ​​(purchased from Wuhan Yingnuo Pharmaceutical Technology), 30 g of phospholipid DHA (CAS No. 59403-52-0, MCE®, product catalog No. HY-W440983), 80 g of proanthocyanidins (MCE® proanthocyanidins, catalog No. HY-N0794), 30 g of curcumin (purchased from Shaanxi Yikanglong Biotechnology), and 30 g of lycopene (purchased from Nanjing Daosifu Biological) were mixed evenly to obtain a solid powder composition AMX-EYE-03.

[0070] Example 2: Test of the function of alleviating visual fatigue

[0071] Healthy 8-month-old New Zealand rabbits (weight 4.45-4.51kg), half male and half female, were selected. They were randomly divided into groups, with 10 rabbits in each group. From the 1st to the 45th day, the experimental group animals were gavaged with a suspension of the composition AMX-EYE-01, AMX-EYE-02 or AMX-EYE-03 prepared by the method described in Example 1 every day (300 mg of the composition was stirred in 5 mL of water for 5 minutes). The negative control group was replaced with an equal volume of normal saline every day. From the 31st to the 34th day, all animals were irradiated with light with an intensity of 5000 Lux every day. Starting from the 35th day, the congestion of the rabbit eyes was observed and recorded every day, and the recovery time of iris and conjunctival congestion (the number of days from the 35th day to the day when the congestion was recovered) was calculated. The results are shown in Table 1 (the average value of each group is taken). Compared with other groups, the AMX-EYE-03 group can significantly reduce the recovery time of iris congestion and conjunctival congestion, both of which have statistically significant differences (P<0.01). This shows that the composition AMX-EYE-03 can significantly relieve eye fatigue, and the components have a synergistic effect, achieving unexpected technical effects.

[0072] Table 1. Test of visual fatigue relief function Average recovery time of iris congestion / day Average recovery time of conjunctival hyperemia / day AMX-EYE-01 Group 7.5 7.1 AMX-EYE-02 Group 7.3 6.4 AMX-EYE-03 Group 1.7 1.3 Negative control group 10.9 10.5 Example 3: Functional test for improving macular degeneration

[0073] Healthy Kunming mice weighing 19.4-20.1g and aged 3 weeks were selected, half male and half female. Each mouse was fed 5g of high-fat diet per day. After 5 months, the model of high-fat-induced macular degeneration was successfully established. The mice were randomly divided into 10 groups. The AMX-EYE-03 group continued to be fed with ordinary diet for 1 month, and 0.3mL of AMX-EYE-03 aqueous suspension of 6mg AMX-EYE-03 / 30g body weight was given by gavage every day; the blank control group continued to be fed with ordinary diet for 1 month, and 0.3mL of normal saline was given by gavage every day. After the end of ordinary diet feeding, the mice were killed, the eyeballs were removed, and tissue sections were made and stained. The color images of the sections were continuously captured by a color digital camera. 10 images of each specimen were randomly selected for analysis, and the thickness of Bruch's membrane was measured. The average value of 100 measurements (10 times per image) was taken for each specimen. The average value of each animal in each group was taken. The results are shown in Table 2. Compared with other groups, the AMX-EYE-03 group can significantly reduce the thickness of Bruch's membrane, and the differences are statistically significant (P<0.05), indicating that the composition AMX-EYE-03 can be used for macular degeneration.

[0074] Table 2. Macular degeneration tests Bruch film thickness / micron AMX-EYE-01 Group 1.45 AMX-EYE-02 Group 1.45 AMX-EYE-03 Group 1.40 Blank control group 1.47 Example 4: Some active ingredients of composition AMX-EYE-03

[0075] The solid powder composition AMX-EYE-03 prepared by the method described in Example 1 was stirred at room temperature for 5 hours in a 20-fold weight of ethanol-isopropanol-water mixed solvent (volume ratio 3:1:3), filtered, and the filtrate was evaporated to dryness under reduced pressure to obtain a crude product. The crude product was separated and purified using an InfinityLab Pursuit XRs C18 Preparative HPLC Column (acetonitrile-water gradient elution) to obtain a polypeptide AMX-EYE-P1 (SEQ ID NO: 1) accounting for 0.02% by weight in the composition AMX-EYE-03 and a polypeptide AMX-EYE-P2 (SEQ ID NO: 2) accounting for 0.03% by weight. The structural characterization data of the polypeptides AMX-EYE-P1 and AMX-EYE-P2 are the same as those in the following examples.

[0076] Polypeptide AMX-EYE-P1 (SEQ ID NO: 1): SRTHANNVKGGDYAEVRLVDQETHNK.

[0077] Polypeptide AMX-EYE-P2 (SEQ ID NO: 2): NRQTHSGKSTDNQEGARVYHSTA.

[0078] Example 5: Preparation and characterization of polypeptides

[0079] The crude products of peptides AMX-EYE-P1 and AMX-EYE-P2 were obtained by Fmoc solid phase synthesis using a peptide synthesizer (Aurora, VERSA 110).

[0080] The crude product was dried at 30°C under vacuum conditions; separated and purified using an InfinityLab Pursuit XRs C18Preparative HPLC Column (acetonitrile-water gradient elution) and freeze-dried to obtain polypeptides AMX-EYE-P1 (SEQ ID NO: 1) and AMX-EYE-P2 (SEQ ID NO: 2) with HPLC purities of 96.3% and 95.8%, respectively.

[0081] ESI-MS mass spectrometry analysis showed that its ion peaks were consistent with the molecular weight of the polypeptides of SEQ ID NO: 1 and 2.

[0082] Peptide AMX-EYE-P1: 1 H NMR (400 MHz, DMSO- d 6) δ 8.92-7.98 (m, 36H), 7.67(d, 8H), 7.43 (s, 6H), 7.22 (m, 2H), 7.01-6.92 (m, 2H), 6.85 (s, 2H), 6.63-6.54 (m, 2H), 5.02 (d, 2H), 4.89-3.78 (m, 39H), 3.54 -1.48 (m, 74H), 1.27-0.89 (m, 23H). Example 6: Functional detection of polypeptides

[0083] The same method as in Example 2 was used for testing, and the polypeptide was used instead of each composition for oral administration. The results are shown in Table 3. Compared with the other two groups, the AMX-EYE-P1 group can significantly reduce the recovery time of iris congestion and conjunctival congestion, both of which have statistically significant differences (P<0.001). This shows that the polypeptide AMX-EYE-P1 can significantly relieve eye fatigue.

[0084] Table 3. Test of visual fatigue relief function Average recovery time of iris congestion / day Average recovery time of conjunctival hyperemia / day AMX-EYE-P1 Group 3.5 3.1 AMX-EYE-P2 Group 9.3 9.4 Negative control group 10.9 10.5 Example 7. Preparation of Preparations

[0085] Preparation Example 1: The composition AMX-EYE-03 prepared as described in Example 1 is sterilized by irradiation, granulated, dried, and sized to obtain granules.

[0086] Preparation Example 2: The composition AMX-EYE-03 prepared as described in Example 1 is subjected to irradiation sterilization, granulation, drying, and granulation to obtain composition granules; the composition granules are loaded into soft capsule shells, each capsule shell is loaded with 200 mg of medicine, to obtain soft capsules; the composition granules are loaded into hard capsule shells, each capsule shell is loaded with 200 mg of medicine, to obtain hard capsules.

[0087] Preparation Example 3: The composition AMX-EYE-03 prepared as described in Example 1 was irradiated and sterilized with 60Co radiation at a dose of 3 kGy; 4% by weight of 70% ethanol (V / V) was added to the sterilized mixture to make a soft material, which was then granulated through a 12-mesh sieve; dried at 55 degrees Celsius for 3 hours; and granulated to obtain granules.

[0088] Preparation Example 4: The composition AMX-EYE-03 prepared by the method described in Example 1 is irradiated and sterilized with 60Co radiation and an irradiation dose of 3 kGy; 4% by weight of 70% ethanol (V / V) is added to the sterilized mixture to make a soft material and then granulated through a 12-mesh sieve; dried at 55 degrees Celsius for 3 hours; granulated to obtain composition granules; the composition granules are loaded into capsule shells, each capsule shell is loaded with 500 mg (mass of composition granules), and capsules are obtained.

[0089] Preparation Example 5: The composition AMX-EYE-03 prepared as described in Example 1 is irradiated and sterilized with 60Co radiation at a dose of 3 kGy; 4% by weight of 70% ethanol (V / V) is added to the sterilized mixture to make a soft material, which is then granulated through a 12-mesh sieve; dried at 55 degrees Celsius for 3 hours; granulated to obtain composition granules; the composition granules are loaded into capsule shells, with each capsule shell being loaded with 600 mg (mass of the composition granules) to obtain capsules.

[0090] Preparation Example 6: The composition AMX-EYE-03 prepared as described in Example 1 is irradiated and sterilized with 60Co radiation at a dose of 3 kGy; 4% by weight of 70% ethanol (V / V) is added to the sterilized mixture to make a soft material, which is then granulated through a 12-mesh sieve; dried at 55 degrees Celsius for 3 hours; granulated to obtain composition granules; the composition granules are loaded into capsule shells, with each capsule shell being loaded with 750 mg (mass of the composition granules) to obtain capsules.

[0091] Example 8. Acute toxicity test

[0092] Test sample: AMX-EYE-03 granules prepared as described in Preparation Example 3 of Example 7.

[0093] Experimental environmental conditions: temperature 24.5℃-25.3℃, humidity 54%-60%.

[0094] Experimental animals: 20 healthy, adult clean-grade SD rats weighing 196-210 g, half male and half female.

[0095] Experimental method: The maximum tolerated dose method was used. 100g of the test sample was weighed and added with distilled water to 200mL. The rats were gavaged twice a day at an interval of 4 hours. Each dose was 2mL / 100g body weight. Therefore, the total gavage dose on the day was equivalent to 20,000mg / kg body weight. The rats were fasted for 20 hours before gavage and observed for 7 consecutive days after gavage. The symptoms of poisoning and death were recorded.

[0096] Test results: After intragastric administration, rats showed no obvious signs of poisoning, and no rats died in 7 days. All animals were killed on the 8th day, and the surface of the liver, kidney, heart, lung, spleen, stomach, intestine and other major organs were smooth and normal in size and shape, with no visible pathological changes such as bleeding, congestion, edema, etc. The acute oral LD50 for male and female SD rats was greater than 20,000 mg / kg body weight.

[0097] Conclusion: Acute toxicity test shows that AMX-EYE-03 is non-toxic and has no side effects.

[0098] Although the embodiments of the present disclosure have been described above, it will be understood that the above embodiments are exemplary and do not constitute limitations to the present disclosure. Any modifications, equivalent substitutions and improvements made by ordinary technicians in the field within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A composition for preventing and treating eye diseases and delaying vision loss, characterized in that: The composition comprises the following components in parts by weight: 25-110 parts by weight of wolfberry, 25-95 parts by weight of cassia seed, 10-90 parts by weight of blueberry, 10-95 parts by weight of marigold, 10-90 parts by weight of eyebright grass, 10-90 parts by weight of chuanxiong, 10-90 parts by weight of notoginseng, 20-90 parts by weight of roxburghii, 15-90 parts by weight of golden top pleurotus, 20-90 parts by weight of bilberry, 20-90 parts by weight of Haematococcus pluvialis, 10-85 parts by weight of lutein, 10-90 parts by weight of zeaxanthin, 10-90 parts by weight of retinol, 20-95 parts by weight of ergothioneine, 25-100 parts by weight of beta-carotene, 20-95 parts by weight of vitamin E, 10-90 parts by weight of organic selenium, and phospholipid DHA 20-90 parts by weight, proanthocyanidins 15-90 parts by weight, curcumin 15-80 parts by weight, lycopene 15-95 parts by weight.

2. A composition for preventing and treating eye diseases and delaying vision loss, characterized in that: The composition comprises the following components in parts by weight: 80 parts by weight of wolfberry, 80 parts by weight of cassia seed, 40 parts by weight of blueberry, 70 parts by weight of marigold, 80 parts by weight of eyebright, 50 parts by weight of chuanxiong, 40 parts by weight of notoginseng, 30 parts by weight of roxburghii, 80 parts by weight of golden top pleurotus, 30 parts by weight of bilberry, 80 parts by weight of Haematococcus pluvialis, 70 parts by weight of lutein, 80 parts by weight of zeaxanthin, 30 parts by weight of retinol, 50 parts by weight of ergothioneine, 30 parts by weight of beta-carotene, 30 parts by weight of vitamin E, 40 parts by weight of seleno-L-cysteine, 30 parts by weight of phospholipid DHA, 80 parts by weight of proanthocyanidins, 30 parts by weight of curcumin, and 30 parts by weight of lycopene.

3. A method for preparing a composition for preventing and treating eye diseases and delaying vision loss, characterized in that: The following steps are involved: Take 25-110 parts by weight of wolfberry, 25-95 parts by weight of cassia seed, 10-90 parts by weight of blueberry, 10-95 parts by weight of marigold, 10-90 parts by weight of eyebright grass, 10-90 parts by weight of chuanxiong, 10-90 parts by weight of notoginseng, 20-90 parts by weight of roxburghii, 15-90 parts by weight of golden top pleurotus, 20-90 parts by weight of bilberry, 20-90 parts by weight of Haematococcus pluvialis, 10-85 parts by weight of lutein, 10-90 parts by weight of zeaxanthin, 10-90 parts by weight of retinol, 20-95 parts by weight of ergothioneine, 25-100 parts by weight of beta-carotene, 20-95 parts by weight of vitamin E, 10-90 parts by weight of seleno-L-cysteine, and phospholipid DHA. 20-90 parts by weight, 15-90 parts by weight of proanthocyanidins, 15-80 parts by weight of curcumin and 15-95 parts by weight of lycopene are uniformly mixed to obtain the product.

4. A method for preparing a composition for preventing and treating eye diseases and delaying vision loss, characterized in that: The following steps are involved: Take 80 grams of wolfberry, 80 grams of cassia seed, 40 grams of blueberry, 70 grams of marigold, 80 grams of eyebright, 50 grams of chuanxiong, 40 grams of panax notoginseng, 30 grams of roxburghii, 80 grams of golden top pleurotus, and 30 grams of bilberry; wash them respectively with water, air-dry at room temperature, and grind them into an average particle size of 500 microns; then mix them evenly with 80 grams of Haematococcus pluvialis, 70 grams of lutein, 80 grams of zeaxanthin, 30 grams of retinol, 50 grams of ergothioneine, 30 grams of β-carotene, 30 grams of vitamin E, 40 grams of seleno-L-cysteine, 30 grams of phospholipid DHA, 80 grams of proanthocyanidins, 30 grams of curcumin and 30 grams of lycopene to obtain the mixture.

5. A preparation for preventing and treating eye diseases and delaying vision loss, characterized in that: The preparation comprises the composition according to claim 1 or 2.

6. The preparation according to claim 5, characterized in that The preparation is an oral dosage form.

7. The preparation according to claim 5, characterized in that The dosage form of the preparation is capsule, granule, tablet, oral liquid or pill.

8. The preparation according to claim 5, characterized in that The preparation method of the preparation comprises: The composition of claim 1 or 2 is irradiated and sterilized, with 60Co radiation and an irradiation dose of 3 kGy; 70% ethanol is added to the sterilized mixture at a weight of 4% thereof to make a soft material, and then granulated through a 12-mesh sieve; dried at 55 degrees Celsius for 3 hours; and granulated to obtain granules; or, The composition of claim 1 or 2 is irradiated and sterilized by 60Co radiation with an irradiation dose of 3 kGy; 70% ethanol is added to the sterilized mixture at a weight of 4% to make a soft material, and then granulated through a 12-mesh sieve; dried at 55 degrees Celsius for 3 hours; granulated to obtain composition granules; and the composition granules are loaded into capsule shells to obtain capsules.