A soft capsule composition for eye protection

Abstract

The application provides a soft capsule composition for eye protection, which has the effects of eliminating free radicals, resisting oxidation, protecting eyes, inhibiting tear secretion capacity reduction, relieving eye fatigue and dryness, repairing retina, protecting vision and preventing and controlling myopia, improving eye blood circulation and the like; the soft capsule of the application is more stable in wrapping anthocyanin, has higher bioavailability, significantly improves the preservation rate of anthocyanin, has more effective antioxidant activity, can be released in a positioning mode, and improves the absorption and conversion rate of anthocyanin.

Description

[0001] This application claims priority to Chinese Application No. 202510421889.9, filed on April 7, 2025, entitled “A soft capsule composition for eye protection,” the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention belongs to the field of health products and relates to a soft capsule composition for eye care. This soft capsule composition has the effects of eliminating free radicals, anti-oxidation, eye protection, inhibiting reduced tear secretion, relieving eye fatigue and dryness, repairing the retina, protecting vision, preventing myopia, and improving blood circulation in the eyes. The soft capsules of this invention encapsulate anthocyanins more stably, have higher bioavailability, significantly improve anthocyanin retention, are more effective in anti-oxidation, can be released at specific points, and improve the absorption and conversion rate of anthocyanins. Background Technology

[0003] With the continuous development of information technology and the rapid popularization of electronic products, people are spending more and more time in contact with computers, mobile phones and other electronic products. As a result, eye health problems such as myopia, eye fatigue and dry eyes are becoming increasingly serious, and eye-related health problems need greater attention.

[0004] Blue light from electronic screens can penetrate directly through the lens of the eye and reach the retina, causing atrophy or even death of retinal pigment epithelial cells. Prolonged close-range use of the eyes can lead to ciliary muscle tension and fatigue, as well as thinning of the choroid and elongation of the axial length of the eye, thus causing myopia.

[0005] Anthocyanins are powerful free radical scavengers that can relieve oxidative stress, protect the blood-retinal barrier, strengthen capillaries in the eyes to prevent vascular lesions, and protect the eyes by inhibiting reduced tear secretion, relieving eye fatigue and dryness, protecting vision, and improving myopia.

[0006] However, anthocyanins are relatively unstable and sensitive to factors such as light, temperature, pH, metal ions, and oxidants, which greatly limits their application range.

[0007] In the stomach, anthocyanins are absorbed without deglycosylation via specific transport proteins (such as sodium-dependent glucose cotransporter 1 and facilitated glucose transporter 1), while in the small intestine, they are mainly absorbed in aglycone form. Highly polymeric anthocyanins are readily degraded by colonic microbes into lowly polymeric forms or smaller phenolic acids, thereby improving their absorption and utilization.

[0008] In addition, anthocyanins have an extremely sour and astringent taste. Therefore, it is of great significance to prepare a stable anthocyanin composition that can be released in a targeted manner and improves its taste by expanding its application range and improving its bioavailability. Summary of the Invention

[0009] The purpose of this invention is to provide a soft capsule composition for eye protection. This soft capsule composition has the effects of eliminating free radicals, anti-oxidation, eye protection, inhibiting the reduction of tear secretion, relieving eye fatigue and dryness, repairing the retina, protecting vision, preventing myopia, and improving blood circulation in the eyes. The soft capsule of this invention encapsulates anthocyanins more stably, has higher bioavailability, significantly improves the preservation rate of anthocyanins, and has more effective antioxidant activity. It can release anthocyanins in a targeted manner, improving the absorption and conversion rate of anthocyanins. The contents are also highly homogeneous.

[0010] The soft capsule composition of the present invention has the following advantages:

[0011] 1. It has the effects of improving vision, anti-inflammatory and antibacterial, antioxidant and strong free radical scavenging ability. It can repair mitochondria, inhibit the reduction of tear secretion, relieve eye fatigue and dry eyes, protect vision, prevent myopia and improve blood circulation in the eyes;

[0012] 2. Soft capsules encapsulate anthocyanins more stably, resulting in higher bioavailability, significantly improving anthocyanin preservation rate, and enhancing antioxidant activity;

[0013] 3. Targeted release: The soft capsules can be targeted to the intestines for absorption, improving the absorption and conversion of anthocyanins, further enhancing their bioavailability, in vivo utilization, and absorption rate.

[0014] 4. The contents can remain stable for a long time, are very stable to oxygen in the air, and can prevent oxidation and moisture absorption; the contents have good uniformity and low content deviation; and there is no odor.

[0015] The composition of this invention is targeted at adolescent students.

[0016] The composition of this invention is designed for people who use their eyes for extended periods of time.

[0017] The composition of this invention is intended for working populations performing visual display terminal (VDT) tasks.

[0018] The composition of this invention is intended for people with eye discomfort.

[0019] The compositions of this invention are intended for children.

[0020] The present invention provides a soft capsule composition for eye care, wherein the soft capsule composition comprises anthocyanin-containing berry extract.

[0021] In one embodiment, the soft capsule composition of the present invention further includes other plant extracts beneficial to the eyes; further, the other plant extracts are eyebright extract, bayberry extract, cranberry extract, pine bark extract, parsley extract, citrus extract, ashwagandha extract, echinacea extract, euphorbia extract, galangal extract, longan pulp extract, bergamot extract, calendula extract, chrysanthemum extract, cassia seed extract, mulberry leaf extract, Hangzhou white chrysanthemum extract, ginkgo extract, lotus seedpod anthocyanin extract, grape seed extract, sea buckthorn extract, pycnogenol extract, red grape extract, ginseng extract, celosia seed extract, dodder seed extract, and honeysuckle extract. The extracts include one or more of the following: Buddleja officinalis extract, black sesame extract, dandelion extract, peppermint extract, raspberry extract, honeysuckle berry extract, kumquat extract, olive extract, green tea extract, apple extract, flaxseed extract, black tea extract, red wine extract, mulberry extract, scutellaria baicalensis extract, onion extract, sophora japonica flower extract, milk thistle extract, asparagus extract, rhodiola rosea extract, buckwheat extract, immature bitter orange extract, vine tea extract, dendrobium extract, wolfberry extract, pomegranate extract, turmeric extract, polygonum cuspidatum extract, black ginger extract, red ginseng extract, rhodiola rosea extract, gastrodia elata extract, perilla extract, privet fruit extract, schisandra fruit extract, and cocoa bean extract.

[0022] Eyebright extract contains flavonoids, various amino acids, sugars and other active ingredients. It has the effects of fighting free radicals, promoting blood circulation in the eyes, improving eye function, relieving eye fatigue, promoting tear secretion, relieving dry eyes, protecting and improving vision, and can also promote vasoconstriction, antibacterial, soothe inflammation, and form a protective film on the surface of the eye.

[0023] In a preferred embodiment, the other plant extract in the soft capsule composition of the present invention is eyebright extract.

[0024] In one embodiment, the soft capsule composition of the present invention comprises, wherein the active ingredients of the other plant extracts are one or more of flavonoids, flavonoid compounds, polyphenols, glycosides, polysaccharides, organic acids, sterols, glycosides, volatile oils, saponins, flavanols, triterpenoids, and flavonoid glycosides; further, the active ingredients of the other plant extracts are proanthocyanidins, catechins, piperidin, resveratrol, quercetin, kaempferol, isorhamnetin, terpene lactones, olive polyphenols, oleuropein, tea polyphenols, apple polyphenols, linolenic acid, anthocyanins, citrus flavonoids, flavan-3-ols, baicalin, rutin, hesperidin, and naringin. One or more of the following: silymarin, solanolactone, phenylpropanoid flavonoids, dihydromyricetin, romaine, betaine, ellagic acid, gallic acid, punicin, curcumin, methoxyflavonoids, diphenylheptane derivatives, phenylpropanoids, ginsenosides, rhodioloside, cinnamyl alcohol, chlorogenic acid, gastrodin, gastrogenin, gastrodia polysaccharide, p-hydroxybenzyl alcohol, barisonin, vanillin, betel nut extract, rosmarinic acid derivatives, cinnamic acid derivatives, lutein, ursolic acid, oleanolic acid, dextrorotatory mannose, acetyloleanolic acid, D-mannitol, lignans, pinene, malic acid, citric acid, tartaric acid, luteolin, cococatenic acid, and cocoa flavanol.

[0025] In one embodiment, the soft capsule composition of the present invention includes one or more of the following berry extracts: blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, blueberry extract, acai berry extract, blackberry extract, black goji berry extract, hibiscus extract, elderberry extract, and bosunberry extract.

[0026] In a preferred embodiment, the soft capsule composition of the present invention includes one or more of the following berry extracts: blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, blueberry extract, acai berry extract, and blackberry extract.

[0027] In a more preferred embodiment, the soft capsule composition of the present invention comprises a combination of blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract.

[0028] In a particularly preferred embodiment, the soft capsule composition of the present invention comprises a combination of blackcurrant extract, chokeberry extract, blueberry extract, and maquiberry extract.

[0029] In one embodiment, the soft capsule composition of the present invention contains other plant extract active ingredients beneficial to the eyes as flavonoids and / or flavonoid compounds.

[0030] In one embodiment, the soft capsule composition of the present invention, wherein the active ingredient is a flavonoid compound and / or other eye-beneficial plant extracts, such as eyebright extract, ginkgo extract, or one or more.

[0031] In a preferred embodiment, the soft capsule composition of the present invention contains eyebright extract as the active ingredient, which is a flavonoid compound and / or other plant extracts beneficial to the eyes.

[0032] In one embodiment, the soft capsule composition of the present invention contains proanthocyanidins as the other plant extract active ingredient beneficial to the eyes.

[0033] In a preferred embodiment, the soft capsule composition of the present invention includes one or more of the following: the active ingredient being proanthocyanidins, which are beneficial to the eyes: pine bark extract, grape seed extract, and cranberry extract.

[0034] In one embodiment, the soft capsule composition of the present invention further includes one or more of proanthocyanidins, lutein, zeaxanthin, β-carotene, astaxanthin, unsaturated fatty acids, and taurine.

[0035] In one embodiment, the soft capsule composition of the present invention further includes oil as its contents.

[0036] In one embodiment, the soft capsule composition of the present invention comprises one or more of sunflower seed oil, safflower seed oil, rapeseed oil, olive oil, tea seed oil, walnut oil, flaxseed oil, sunflower oil, corn oil, peanut oil, sesame oil, soybean oil, palm oil, animal oil, mineral oil, MCT oil, and coconut oil.

[0037] In a preferred embodiment, the soft capsule composition of the present invention comprises one or more of sunflower seed oil and MCT oil.

[0038] In a particularly preferred embodiment, the soft capsule composition of the present invention uses MCT oil.

[0039] In one embodiment, the soft capsule composition of the present invention further includes a suspending agent in its contents.

[0040] In one embodiment, the soft capsule composition of the present invention includes one or more of beeswax, polyethylene glycol (PEG), povidone, white beeswax, and ethyl cellulose as the suspending agent.

[0041] In a preferred embodiment, the soft capsule composition of the present invention uses beeswax as the suspending agent.

[0042] In one embodiment, the ratio of suspending agent to oil in the soft capsule composition of the present invention is 1:5 to 1:50.

[0043] In a preferred embodiment, the ratio of suspending agent to oil in the soft capsule composition of the present invention is 1:5 to 1:20.

[0044] In a more preferred embodiment, the ratio of suspending agent to oil in the soft capsule composition of the present invention is 1:10 to 1:20.

[0045] In a particularly preferred embodiment, the soft capsule composition of the present invention has a suspending agent to oil ratio of 1:15 to 1:20.

[0046] In one embodiment, the soft capsule composition of the present invention includes a plasticizer and a gelling agent in the capsule shell.

[0047] In one embodiment, the soft capsule composition of the present invention includes one or more of glycerol, sorbitol, maltitol, erythritol, xylitol, crystalline fructose, trehalose, and glucose as the plasticizer.

[0048] In a preferred embodiment, the soft capsule composition of the present invention uses one or more of glycerin and sorbitol as the plasticizer.

[0049] In a more preferred embodiment, the soft capsule composition of the present invention comprises a plasticizer being a combination of glycerin and sorbitol.

[0050] In one embodiment, the soft capsule composition of the present invention has a sorbitol to glycerol ratio of 1:1 to 1:20.

[0051] In a preferred embodiment, the soft capsule composition of the present invention has a sorbitol to glycerol ratio of 1:5 to 1:20.

[0052] In a more preferred embodiment, the soft capsule composition of the present invention has a sorbitol to glycerol ratio of 1:5 to 1:15.

[0053] In one embodiment, the soft capsule composition of the present invention comprises one or more of gelatin, carrageenan, agar, sodium alginate, pectin, pullulan, konjac gum, xanthan gum, locust bean gum, guar gum, flaxseed gum, guar gum, tamarind gum, starch, and carbomer.

[0054] In a preferred embodiment, the soft capsule composition of the present invention uses gelatin as the gelling agent.

[0055] In one embodiment, the soft capsule composition of the present invention has a plasticizer and gelling agent in a ratio of 1:1 to 1:15.

[0056] In a preferred embodiment, the ratio of the plasticizer to the gelling agent in the soft capsule composition of the present invention is 1:1 to 1:10.

[0057] In a more preferred embodiment, the ratio of the plasticizer to the gelling agent in the soft capsule composition of the present invention is 1:1 to 1:5.

[0058] In one embodiment, the soft capsule composition of the present invention includes one or more of delphinidin, cyanidin, geraniumin, paeoniflorin, iridoside, and malvidin.

[0059] In one embodiment, the soft capsule composition of the present invention contains anthocyanins in the form of glycosides.

[0060] In one embodiment, the soft capsule composition of the present invention comprises one or more of the following anthocyanins: glucose, galactose, rutin, mulberry polysaccharide, arabinose, xylose, mulberry disaccharide, and disaccharide.

[0061] In one embodiment, the soft capsule composition of the present invention contains delphinidin in the berry extract at a content of ≥5%.

[0062] In one embodiment, the soft capsule composition of the present invention comprises at least one or more of the following active ingredients of the berry extract: delphinidin-3-O-glucoside, delphinidin-3-morula-glucoside, delphinidin-3,5-diglucoside, delphinidin-3-morula-glucoside, delphinidin-3-O-rutin glycoside, cyanidin-3-O-galactoside, cyanidin-3-O-glucoside, cyanidin-3-O-arabinoside, cyanidin-3-O-rutin glycoside, cyanidin-3-morula-disaccharide-5-glucoside, and cyanidin disaccharide.

[0063] In one embodiment, the soft capsule composition of the present invention comprises blackcurrant extract and maqui berry extract in a ratio of 9:1 to 1:20.

[0064] In one embodiment, the soft capsule composition of the present invention comprises blackcurrant extract and maqui berry extract in a ratio of 9:1 to 1:9.

[0065] In a preferred embodiment, the soft capsule composition of the present invention contains blackcurrant extract and maqui berry extract in a ratio of 5:1 to 1:9.

[0066] In a more preferred embodiment, the soft capsule composition of the present invention contains blackcurrant extract and maqui berry extract in a ratio of 2:1 to 1:9.

[0067] In a particularly preferred embodiment, the soft capsule composition of the present invention comprises blackcurrant extract and maqui berry extract in a ratio of 1:1 to 1:5.

[0068] In one embodiment, the soft capsule composition of the present invention contains a blackcurrant extract content greater than or equal to 1% of the berry extract content.

[0069] In one embodiment, the soft capsule composition of the present invention contains blackcurrant extract at a content of 5-15% of the berry extract, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15%.

[0070] In a preferred embodiment, the blackcurrant extract content of the soft capsule composition of the present invention is 5-10%.

[0071] In one embodiment, the soft capsule composition of the present invention contains an anthocyanin content of ≥10%, preferably ≥20%, and more preferably ≥30% in the blackcurrant extract.

[0072] In one embodiment, the soft capsule composition of the present invention contains chokeberry extract at a content greater than or equal to 10% of the berry extract content.

[0073] In one embodiment, the soft capsule composition of the present invention contains 20-80% aronia berry extract as a percentage of the berry extract, such as 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 72, 73, 74, 75, 76, 77, 78, 79, 80%.

[0074] In a preferred embodiment, the soft capsule composition of the present invention contains 50-80% aronia berry extract.

[0075] In a more preferred embodiment, the soft capsule composition of the present invention contains 65-75% aronia berry extract.

[0076] In one embodiment, the soft capsule composition of the present invention contains ≥5% anthocyanin in the aronia berry extract, preferably ≥10% anthocyanin, and more preferably ≥20% anthocyanin.

[0077] In one embodiment, the soft capsule composition of the present invention contains ≥10% anthocyanin in the blueberry extract, preferably ≥20%, and more preferably ≥30%.

[0078] In one embodiment, the soft capsule composition of the present invention contains a maquillberry extract content greater than or equal to 1% of the berry extract content.

[0079] In one embodiment, the soft capsule composition of the present invention contains 5-70% of the maqui berry extract.

[0080] In one embodiment, the soft capsule composition of the present invention contains 5-60% of the maqui berry extract.

[0081] In one embodiment, the soft capsule composition of the present invention contains 10-60% of the maqui berry extract.

[0082] In one embodiment, the soft capsule composition of the present invention contains 10-50% of the maqui berry extract.

[0083] In one embodiment, the soft capsule composition of the present invention contains 10-35% maquilli extract, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, or 35%.

[0084] In a more preferred embodiment, the soft capsule composition of the present invention contains 15-25% of the maquill extract.

[0085] In one embodiment, the soft capsule composition of the present invention contains an anthocyanin content of ≥20%, preferably ≥40%, and more preferably ≥60% in the maquill extract.

[0086] In one embodiment, the active ingredient of the blackcurrant extract in the soft capsule composition of the present invention is one or more of delphinidin-3-O-glucoside, delphinidin-3-O-rutinoside, cyanidin-3-O-glucoside, and cyanidin-3-O-rutinoside.

[0087] In one embodiment, the active ingredient of the aronia berry extract in the soft capsule composition of the present invention is one or more of cyanidin-3-O-galactoside, cyanidin-3-O-glucoside, cyanidin-3-O-arabinoside, and cyanidin-3-xyloside.

[0088] In one embodiment, the active ingredient of the soft capsule composition of the present invention is one or more of delphinidin-3-morula-glucoside, delphinidin-3,5-diglucoside, cyanidin-3-morula-biglycoside-5-glucoside, cyanidin diglucoside, delphinidin-3-morula-biglycoside, delphinidin-3-glucoside, anthocyanin-3-morula-biglycoside, and cyanidin-3-O-glucoside.

[0089] In one embodiment, the soft capsule composition of the present invention comprises, at least, delphinidin-3-O-glucoside as an active ingredient of the blackcurrant extract.

[0090] In one embodiment, the soft capsule composition of the present invention comprises at least one or more of delphinidin-3-O-glucoside, delphinidin-3-sangbu-glucoside, and delphinidin-3,5-diglucoside as the active ingredient of the maquill extract.

[0091] In a preferred embodiment, the soft capsule composition of the present invention contains delphinidin in the berry extract at a content of ≥10%.

[0092] In a more preferred embodiment, the soft capsule composition of the present invention contains delphinidin in the berry extract at a content of ≥15%.

[0093] In a particularly preferred embodiment, the soft capsule composition of the present invention contains 10-20% delphinidin in the berry extract.

[0094] In some embodiments, the soft capsule composition of the present invention comprises, as a functional ingredient, at least delphinidin-3-O-glucoside; the delphinidin-3-O-glucoside is present in a content ≥1% in the composition, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10%.

[0095] In a preferred embodiment, the soft capsule composition of the present invention contains delphinidin-3-O-glucoside in the berry extract composition at a content of ≥2%.

[0096] In a more preferred embodiment, the soft capsule composition of the present invention contains 2-5% delphinidin-3-O-glucoside in the berry extract composition.

[0097] In one embodiment, the soft capsule composition of the present invention comprises at least one or more of delphinidin-3-O-glucoside, delphinidin-3-sangbu-glucoside, and delphinidin-3,5-diglucoside as its active ingredient.

[0098] In one embodiment, the soft capsule composition of the present invention comprises at least one or more of delphinidin-3-glucoside and delphinidin-3,5-diglucoside as its active ingredient.

[0099] In some embodiments, the soft capsule composition of the present invention contains delphinidin-3-morula-glucoside at a content of ≥1%, such as 1, 2, 3, 4, 5, 6, or 7%.

[0100] In some embodiments, the soft capsule composition of the present invention contains delphinidin-3,5-diglucoside at a content ≥1%, such as 1%, 2%, 3%, 4%, or 5%.

[0101] In a preferred embodiment, the soft capsule composition of the present invention contains ≥2% delphinidin-3-mori-glucoside in the berry extract composition.

[0102] In a more preferred embodiment, the soft capsule composition of the present invention contains 2-5% delphinidin-3-morula-glucoside in the berry extract composition.

[0103] In a preferred embodiment, the soft capsule composition of the present invention contains ≥2% delphinidin-3,5-diglucoside in the berry extract composition.

[0104] In a more preferred embodiment, the soft capsule composition of the present invention contains 2-5% delphinidin-3,5-diglucoside in the berry extract composition.

[0105] In some embodiments, the soft capsule composition of the present invention has an anthocyanin content of ≥10%, such as 10, 15, 20, 25, 30, 35, 40, 45, or 50%.

[0106] In a preferred embodiment, the soft capsule composition of the present invention has an anthocyanin content of ≥20% for the berry extract composition.

[0107] In a more preferred embodiment, the soft capsule composition of the present invention has an anthocyanin content of ≥30%.

[0108] In one embodiment, the soft capsule composition of the present invention contains eyebright extract in the form of 1-200 mg / serving.

[0109] In one embodiment, the soft capsule composition of the present invention contains 50-150 mg / serving of eyebright extract.

[0110] In a preferred embodiment, the soft capsule composition of the present invention contains eyebright extract in the form of 70-150 mg / serving.

[0111] In one embodiment, the soft capsule composition of the present invention contains 1-150 mg of berry extract per serving.

[0112] In one embodiment, the soft capsule composition of the present invention contains 30-100 mg / serving of berry extract.

[0113] In a preferred embodiment, the soft capsule composition of the present invention contains 40-100 mg / serving of berry extract.

[0114] In one embodiment, the soft capsule composition of the present invention comprises a ratio of berry extract to eyebright extract of 9:1 to 1:9.

[0115] In a preferred embodiment, the soft capsule composition of the present invention comprises a ratio of berry extract and eyebright extract of 5:1 to 1:9.

[0116] In a more preferred embodiment, the soft capsule composition of the present invention comprises a ratio of berry extract to eyebright extract of 1:1 to 1:9.

[0117] In a particularly preferred embodiment, the soft capsule composition of the present invention comprises a ratio of berry extract to eyebright extract of 1:1 to 1:5.

[0118] In a particularly preferred embodiment, the soft capsule composition of the present invention comprises a ratio of berry extract to eyebright extract of 1:1 to 1:3.

[0119] In one embodiment, the soft capsule composition of the present invention comprises eyebright extract at a concentration of 50-150 mg / part and berry extract at a concentration of 30-100 mg / part.

[0120] In a preferred embodiment, the soft capsule composition of the present invention contains 70-150 mg / part of eyebright extract and 40-100 mg / part of berry extract.

[0121] In one embodiment, the preparation method of the berry extract (such as blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, blueberry extract, etc.) / eyebright grass extract specifically includes: (1). Selecting and processing plant raw materials, such as washing, cutting or crushing;

[0122] (2) Active ingredients are extracted using enzymatic hydrolysis, water extraction, alcohol extraction, ultrasonic extraction, and supercritical fluid extraction.

[0123] (3) The extract was separated and purified by methods such as filtration, centrifugation, chromatography, membrane separation and crystallization;

[0124] (4) Concentrate and dry the extract using techniques such as evaporation, freeze drying or spray drying.

[0125] In one embodiment, the method for preparing the soft capsule composition includes:

[0126] A. Add purified water and excipients (such as plasticizers and gelling agents) and mix well;

[0127] B. Heating and gelling to obtain a glue solution, which is then stabilized to obtain a rubber sheet of uniform thickness;

[0128] C. Weigh the raw materials and add food-acceptable excipients (suspending agents, oils) to obtain the contents;

[0129] D. The contents are pressed or dripped into the gelatin shell to obtain a soft capsule composition.

[0130] The present invention also provides the use of any of the soft capsule compositions in eliminating free radicals, anti-oxidation, eye protection, inhibiting the reduction of tear secretion, relieving eye fatigue and dry eyes, repairing the retina, protecting vision, preventing myopia, and improving blood circulation in the eyes.

[0131] The present invention also provides the use of any of the described soft capsule compositions in eye care.

[0132] The present invention also provides the use of any of the soft capsule compositions in repairing the retina, protecting vision, preventing myopia, and improving blood circulation in the eyes.

[0133] The present invention also provides the use of any of the soft capsule compositions in inhibiting reduced tear secretion and relieving eye fatigue and dry eyes. Attached Figure Description

[0134] Figure 1 This is a schematic diagram of a soft capsule. Detailed Implementation

[0135] To facilitate understanding by those skilled in the art, the present invention will be further described below with reference to embodiments. The content mentioned in the embodiments is not intended to limit the present invention.

[0136] Example

[0137] A berry extract composition was obtained by adding blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract. The proportions refer to the percentage of the additives in the berry extract composition.

[0138] Example

[0139] Blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract were added in any of the amounts specified in Examples 1-5 to obtain a berry extract composition, wherein the anthocyanin content of the above berry extract composition was 30%.

[0140] Example 7

[0141] Blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract were added in any of the amounts specified in Examples 1-5 to obtain a berry extract composition, wherein the anthocyanin content of the above berry extract composition was 35%.

[0142] Example 8

[0143] Blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract were added in any of the amounts specified in Examples 1-5 to obtain a berry extract composition, wherein the anthocyanin content of the above berry extract composition was 25%.

[0144] Example 9

[0145] Blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract were added in any of the amounts specified in Examples 1-5 to obtain a berry extract composition, wherein the anthocyanin content of the above berry extract composition was 40%.

[0146] Example 10

[0147] Blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract were added in any of the amounts specified in Examples 1-5 to obtain a berry extract composition, wherein the delphinidin content in the above berry extract composition was 10%.

[0148] Example 11

[0149] Blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, and blueberry extract were added in any of the amounts specified in Examples 1-5 to obtain a berry extract composition, wherein the delphinidin content in the above berry extract composition was 15%.

[0150] Example 12

[0151] The composition was obtained by adding any one of the berry extract compositions from Examples 1-11 and eyebright extract.

[0152] Example 13

[0153] The composition was obtained by adding 70 mg of any one of the berry extract compositions from Examples 1-11 and 100 mg of eyebright extract.

[0154] Example 14

[0155] The composition was obtained by adding 35 mg of any one of the berry extract compositions from Examples 1-11 and 50 mg of eyebright extract.

[0156] Example 15

[0157] The composition was obtained by adding 30 mg of any one of the berry extract compositions from Examples 1-11 and 50 mg of eyebright extract.

[0158] Example: Rubber preparation

[0159] Mix the gelling agent and plasticizer in a suitable ratio beforehand, and weigh the mixture.

[0160]

[0161] Example Contents Preparation

[0162]

[0163] Example 22 Soft Capsule Composition

[0164] The eyebright extract and berry extract were mixed together, and excipients (MCT oil and beeswax) were added. The mixture was stirred until homogeneous to obtain the contents.

[0165] A certain amount of gelatin, glycerin, sorbitol syrup, and pigment were weighed, heated, and stirred until evenly mixed to prepare a soft capsule shell. The contents were then filled into the shell to obtain the soft capsule composition.

[0166] Biological test cases

[0167] Test Example 1: Stability Test

[0168] According to the operational guidelines for stability testing of health food products in China, the stability of the soft capsule composition of this invention was tested by accelerated testing.

[0169] The peroxide value of the soft capsule composition of the present invention was tested according to the first method of GB5009.227-2023, and the result was that the peroxide value of the soft capsule composition of the present invention was less than 0.05g / 100g.

[0170] Test Example 2: Collapse Time Limit Test

[0171] According to the requirements of General Chapter 0921, Part IV, of the 2020 edition of the Chinese Pharmacopoeia, the disintegration time of the soft capsule composition of the present invention was tested. The results showed that the disintegration time of the soft capsule composition of the present invention was less than 30 minutes.

[0172] Test Example 3: Colony Detection

[0173] The total bacterial count was determined according to GB4789.2-2022; the parameters for molds and yeasts were determined according to the first method of GB4789.15-2016; the parameters for coliform bacteria were determined according to the first method of GB 4789.3-2016; the parameters for Staphylococcus aureus were determined according to the first method of GB 4789.10-2016; and the parameters for Salmonella were determined according to GB 4789.4-2024.

[0174] According to the requirements of General Chapter 1108 of Part IV of the 2020 edition of the Chinese Pharmacopoeia, the soft capsule composition of the present invention was tested for bile-resistant Gram-negative bacteria and Escherichia coli.

[0175] Bile-tolerant Gram-negative bacteria

[0176] Preparation and pre-culture of test solution: Take the test sample and prepare a 1:10 test solution using trypsin-soybean stale liquid test solution preparation and pre-culture medium as a diluent, according to the "Method Suitability Test" section of "Microbial Counting" above. Mix well and incubate at 20-25°C. The incubation time should allow the bacteria in the test sample to fully recover but not proliferate (approximately 2 hours).

[0177] Selection and isolation culture: Pre-cultures of the test sample, equivalent to 0.1 g, 0.01 g, and 0.001 g (or other suitable sequential 3-stage dilutions), are inoculated into appropriate volumes (determined by method suitability testing) of enteric enrichment broth. The amount of test solution added should not exceed 10% of the broth volume. Incubate at 30–35°C for 24–48 hours. Each culture is then streaked onto purple-red bile salt glucose agar plates and incubated at 30–35°C for 18–24 hours.

[0178] Result interpretation: If colonies grow on the purple-red bile salt glucose agar plate, the corresponding culture tube is positive; otherwise, it is negative. Based on the test results of each culture tube, determine the possible number of bile salt-resistant Gram-negative bacteria in 1g or 1ml of the test sample from Table 3.

[0179] Table 3. Possible number (N) of bile salt-resistant Gram-negative bacteria

[0180]

[0181] Note: (1) + indicates that there is colony growth on the purple bile dextrose agar plate; - indicates that there is no colony growth on the purple bile dextrose agar plate.

[0182] (2) If the amount of test sample is reduced by 10 times (e.g., 0.01g or 0.01ml, 0.001g or 0.001ml, 0.0001g or 0.0001ml), the possible number of bacteria (N) in each 1g of test sample should be increased by 10 times accordingly.

[0183] Escherichia coli

[0184] Preparation of test solution and enrichment culture: Take the test sample and prepare a 1:10 test solution according to the "Method Suitability Test" section of "Microbial Counting" above. Take the test solution equivalent to 1g of the test sample and inoculate it into an appropriate volume (determined by the method suitability test) of tryptic soy peptone liquid medium. The amount of test solution added should not exceed 10% of the volume of the medium. Mix well and incubate at 30-35°C for 18-24 hours.

[0185] Selection and isolation culture: Take 1 ml of the above culture and inoculate it into 100 ml of MacConkey liquid medium, and incubate at 42-44°C for 24-48 hours. Streak the MacConkey liquid culture onto MacConkey agar plates and incubate at 30-35°C for 18-72 hours.

[0186] Result interpretation: If colonies grow on MacConkey agar plates, isolation, purification, and appropriate identification tests should be performed to confirm whether it is Escherichia coli; if no colonies grow on MacConkey agar plates, or if colonies grow but the identification result is negative, it is determined that Escherichia coli was not detected in the test sample.

[0187] The test results are shown in the table below.

[0188]

[0189] Test Example 4: Average Fill Weight Test

[0190] According to the requirements of General Chapter 0100, Part IV, Chinese Pharmacopoeia 2020, the average fill weight of the soft capsule composition of the present invention was tested.

[0191] The "filling volume difference" should be checked according to the following method and should comply with the regulations.

[0192] Unless otherwise specified, the testing method involves taking 20 capsules (10 capsules for traditional Chinese medicine), accurately weighing each, and emptying the contents (without damaging the capsule shell). For hard capsules, clean the shells with a small brush or other suitable tool; for soft capsules or hard capsules containing semi-solid or liquid contents, wash the shells with a volatile solvent such as ethyl acetate, place them in a ventilated area to allow the solvent to evaporate, and then accurately weigh each capsule shell to determine the content of each capsule and the average content. Compare the content of each capsule with the average content (for capsules with a labeled content, the content of each capsule should be compared with the labeled content). No more than two capsules should exceed the content difference limit, and no single capsule should exceed the limit by more than 100%.

[0193]

[0194] For capsules that are required to have their content uniformity checked, the content difference check is generally no longer required.

[0195] The average weight of the soft capsule composition of the present invention is 0.2-0.3g, and the average content is 100-150mg.

[0196] Test Example 5: Anthocyanin Content Detection

[0197] 1. Method Principles

[0198] The anthocyanins in the soft capsule composition of this invention are directly separated and determined by high performance liquid chromatography (HPLC). Gradient elution is performed using formic acid-water and acetonitrile-methanol-formic acid-water solutions as mobile phases, and detection is performed at a wavelength of 535 nm. Quantification is achieved using the external standard method.

[0199] 2. Sample preparation

[0200] Mix the contents of the capsule thoroughly and set aside.

[0201] 3. Sample extraction

[0202] Weigh an appropriate amount of sample (accurate to 0.1 mg) into a 50 mL centrifuge tube, add 25 mL of hydrochloric acid methanol solution, place on a multi-tube shaker and shake at 2500 r / min for 5 min, then sonicate for 10 min (temperature not exceeding 30°C). After the sample solution has cooled, transfer it to a 100 mL brown volumetric flask, rinse the centrifuge tube three times with 10% phosphoric acid solution, combine the washings in a 100 mL brown volumetric flask, dilute to the mark with 10% phosphoric acid solution, shake well, filter through a 0.45 μm filter membrane, and use for liquid chromatography determination.

[0203] 4. Determination by liquid chromatography

[0204] The standard working solution and the sample solution to be tested are injected in equal volumes. The retention time of the chromatographic peak of the sample solution is qualitatively determined based on the retention time and peak area of ​​the chromatographic peak of the standard solution, and the external standard method is used for quantification.

[0205] The total anthocyanins (calculated as delphinidin-3-O-rutin) in the soft capsule composition of the present invention were found to be 10-13 mg / capsule.

[0206] According to the first method of GB 5009.82-2016, the vitamin A (calculated as retinol) content in the soft capsule composition of the present invention is 40-90 µg / capsule.

[0207] It will be understood by those skilled in the art that, unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. It should also be understood that terms such as those defined in general dictionaries should be understood to have the same meaning as in the context of the prior art, and should not be interpreted in an idealized or overly formal sense unless specifically defined as herein.

[0208] It should be understood that the above detailed description of the technical solutions of the present invention with reference to preferred embodiments is illustrative and not restrictive. Those skilled in the art can modify the technical solutions described in the embodiments or make equivalent substitutions for some of the technical features based on reading this specification; however, these modifications or substitutions do not cause the essence of the corresponding technical solutions to depart from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A soft capsule composition for eye care, wherein, The composition includes anthocyanin-containing berry extracts.

2. The soft capsule composition according to claim 1, characterized in that, It also includes other plant extracts beneficial to the eyes; further, these other plant extracts include eyebright extract, bayberry extract, cranberry extract, pine bark extract, parsley extract, citrus extract, ashwagandha extract, echinacea extract, eucalyptus extract, galangal extract, longan pulp extract, bergamot extract, calendula extract, chrysanthemum extract, cassia seed extract, mulberry leaf extract, Hangzhou white chrysanthemum extract, ginkgo extract, lotus seedpod anthocyanin extract, grape seed extract, sea buckthorn extract, pycnogenol extract, red grape extract, ginseng extract, celosia seed extract, dodder seed extract, honeysuckle extract, buddleja extract, and black sesame extract. One or more of the following extracts: hemp extract, dandelion extract, peppermint extract, raspberry extract, honeysuckle berry extract, kumquat extract, olive extract, green tea extract, apple extract, flaxseed extract, black tea extract, red wine extract, mulberry extract, scutellaria baicalensis extract, onion extract, sophora japonica flower extract, milk thistle extract, asparagus extract, rhodiola rosea extract, buckwheat extract, immature bitter orange extract, vine tea extract, dendrobium extract, wolfberry extract, pomegranate extract, turmeric extract, polygonum cuspidatum extract, black ginger extract, red ginseng extract, rhodiola rosea extract, gastrodia elata extract, perilla extract, privet fruit extract, schisandra fruit extract, and cocoa bean extract.

3. The soft capsule composition according to claim 2, characterized in that, The active ingredients of the other plant extracts are one or more of the following: flavonoids, flavonoid compounds, polyphenols, glycosides, polysaccharides, organic acids, sterols, glycosides, volatile oils, saponins, flavanols, triterpenoids, and flavonoid glycosides; further, the active ingredients of the other plant extracts are proanthocyanidins, catechins, piperidin, resveratrol, quercetin, kaempferol, isorhamnetin, terpene lactones, olive polyphenols, oleuropein, tea polyphenols, apple polyphenols, linolenic acid lignans, anthocyanins, citrus flavonoids, flavan-3-ols, baicalin, rutin, hesperidin, naringin, silymarin, and solanolactone. Phenylacetic flavonoids, dihydromyricetin, romaine, betaine, ellagic acid, gallic acid, punicin, curcumin, methoxyflavonoids, diphenylheptane derivatives, phenylpropanoids, ginsenosides, rhodioloside, cinnamyl alcohol, chlorogenic acid, gastrodin, gastrogenin, gastrodia polysaccharide, p-hydroxybenzyl alcohol, barisonin, vanillin, betel nut extract, rosmarinic acid derivatives, cinnamic acid derivatives, lutein, ursolic acid, oleanolic acid, dextro-mannose, acetyloleanolic acid, D-mannitol, lignans, pinene, malic acid, citric acid, tartaric acid, luteolin, cococatenic acid, and one or more of the following.

4. The soft capsule composition according to claim 1, characterized in that, The berry extract is one or more of the following: blackcurrant extract, chokeberry extract, blueberry extract, maquiberry extract, blueberry extract, acai berry extract, blackberry extract, black goji berry extract, hibiscus extract, elderberry extract, and bosunberry extract.

5. The soft capsule composition according to claim 4, characterized in that, The berry extract contains ≥5% delphinidin.

6. The soft capsule composition according to claim 5, characterized in that, The ratio of blackcurrant extract to maquiberry extract in the berry extract is 9:1 to 1:

20.

7. The soft capsule composition according to claim 1, characterized in that, The composition further includes one or more of proanthocyanidins, lutein, zeaxanthin, β-carotene, astaxanthin, unsaturated fatty acids, and taurine.

8. The soft capsule composition according to claim 1, characterized in that, The contents also include oil; further, the oil is one or more of sunflower oil, safflower oil, rapeseed oil, olive oil, tea seed oil, walnut oil, flaxseed oil, sunflower oil, corn oil, peanut oil, sesame oil, soybean oil, palm oil, animal oil, mineral oil, medium-chain triglyceride oil (MCT oil), and coconut oil.

9. The soft capsule composition according to claim 1, characterized in that, The contents also include a suspending agent; further, the suspending agent is one or more of beeswax, polyethylene glycol (PEG), povidone, white beeswax, and ethyl cellulose.

10. The soft capsule composition according to claim 9, characterized in that, The ratio of suspending agent to oil is 1:5 to 1:

50.

11. The soft capsule composition according to claim 1, characterized in that, The soft capsule shell includes plasticizers and gelling agents.

12. The soft capsule composition according to claim 11, characterized in that, The plasticizer is one or more of glycerol, sorbitol, maltitol, erythritol, xylitol, crystalline fructose, trehalose, and glucose.

13. The soft capsule composition according to claim 11, characterized in that, The gelling agent is one or more of gelatin, carrageenan, agar, sodium alginate, pectin, pullulan, konjac gum, xanthan gum, locust bean gum, guar gum, flaxseed gum, guar gum, tamarind gum, starch, and carbomer.

14. The soft capsule composition according to claim 11, characterized in that, The ratio of plasticizer to gelling agent is 1:1 to 1:

15.

15. The soft capsule composition according to any one of claims 1-14, and its use in eye care, relieving eye fatigue and dryness, repairing the retina, protecting vision, preventing myopia, and improving blood circulation in the eyes.

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