A moisturizing eye composition and method of making and using same

Abstract

The application belongs to the technical field of compositions, and provides a moisturizing eye composition, a preparation method and application thereof. The moisturizing eye composition provided by the application is combined by soybean lecithin, retinol palmitate liposome, lutein, oligomeric hyaluronic acid and ethylenediaminetetraacetic acid in a specific ratio, and good synergies can be achieved among the components, the effect of relieving asthenopia, protecting eyesight and maintaining normal vision is improved, and the effect of improving and relieving the symptoms of dry eyes and dry eyes caused by various reasons (such as fatigue, wearing contact lenses, using electronic products, overuse of eyes, etc.) is improved.

Description

Technical Field

[0001] This invention relates to the field of composition technology, and more specifically, to a moisturizing eye composition, its preparation method, and its application. Background Technology

[0002] Insufficient or excessive lutein intake leading to light-induced damage is a major cause of myopia and amblyopia. Currently available ophthalmic products for dry and itchy eyes caused by fatigue, contact lens wear, electronic device use, and excessive eye strain can only relieve these symptoms; they do not alleviate eye strain, protect vision, or maintain normal visual function.

[0003] Therefore, there is an urgent need to develop an eye care product that can not only relieve dry and itchy eyes, but also relieve eye fatigue, protect vision, and maintain normal vision. Summary of the Invention

[0004] The present invention aims to at least solve one of the technical problems existing in the prior art. To this end, the present invention proposes a moisturizing eye-care composition, its preparation method, and its application. The moisturizing eye-care composition provided by the present invention can not only relieve symptoms of dry and itchy eyes, but also relieve symptoms of eye fatigue, protect vision, and maintain normal visual function.

[0005] A first aspect of the present invention provides a moisturizing eye composition.

[0006] Specifically, a moisturizing eye care composition comprises, by weight, the following components:

[0007] Soybean lecithin 0.1-10 parts, retinyl palmitate liposomes 1-5 parts, lutein 1.2-5 parts, oligomeric hyaluronic acid (oligomeric HA) 0.1-10 parts, ethylenediaminetetraacetic acid (EDTA) 0.01-10 parts.

[0008] Lutein plays an important protective role in the macula of the retina, effectively relieving eye fatigue symptoms and protecting vision. Retinyl palmitate liposomes have improved permeability and are biocompatible with the skin, reducing sensitivity to light, temperature, and oxygen, thus effectively maintaining normal visual function. Oligomeric hyaluronic acid (HA) is a component of human skin and is the most widely distributed acidic mucosaccharide in the human body, present in the matrix of connective tissue. It has excellent moisturizing properties and is used to relieve dry eye syndrome. This invention uses a specific ratio of soybean lecithin, retinyl palmitate liposomes, lutein, oligomeric hyaluronic acid, and EDTA. Retinyl palmitate liposomes reduce the eye's sensitivity to light, temperature, and oxygen, maintaining normal visual function and thus protecting vision. Lutein relieves eye fatigue symptoms and protects vision. The effects of retinyl palmitate liposomes and lutein complement each other, not only relieving eye fatigue, dryness and irritation caused by wearing contact lenses, using electronic products, and excessive eye strain, but also significantly improving the effects of relieving eye fatigue symptoms, protecting vision, and maintaining normal vision.

[0009] Preferably, the moisturizing eye-moisturizing composition further includes at least one of a lubricant, a humectant, a pH buffer, menthol, and water.

[0010] More preferably, the moisturizing eye-care composition further comprises, by weight, 0.2-5 parts lubricant, 1-10 parts humectant, 0.02-15 parts pH buffer, 0.12-10 parts menthol, and 80-100 parts water.

[0011] Preferably, the lubricant is polyoxyethylene 40 hydrogenated castor oil.

[0012] Preferably, the humectant is polyethylene glycol 400 (PEG400) and / or glycerin.

[0013] Preferably, the pH buffer is sodium dihydrogen phosphate and / or disodium hydrogen phosphate.

[0014] More preferably, the moisturizing eye-care composition comprises, by weight, 0.1-10 parts soybean lecithin, 1-5 parts retinyl palmitate liposomes, 1.2-5 parts lutein, 0.1-10 parts oligomeric hyaluronic acid, 0.01-10 parts ethylenediaminetetraacetic acid, 0.2-5 parts polyoxyethylene 40 hydrogenated castor oil, 0.2-5 parts polyethylene glycol 400, 1-5 parts glycerin, 0.042-3 parts sodium dihydrogen phosphate, 0.25-10 parts disodium hydrogen phosphate, 0.12-10 parts menthol, and 80-100 parts water.

[0015] PEG400 and glycerin are miscible with water in any proportion, are not easily volatile, and act as humectants to absorb and retain moisture. Sodium dihydrogen phosphate and disodium hydrogen phosphate are used to adjust the product's pH, osmotic pressure, and overall pH level to closely match the eye's environment and intraocular pressure. This prevents dehydration or water absorption after product use, thus avoiding any increase or decrease in intraocular pressure. As pH buffers, sodium dihydrogen phosphate and disodium hydrogen phosphate work together to maintain the product's neutral pH, ensuring stability and preventing eyelid irritation; they are gentle on the skin. Menthol is used as a stimulant, acting on the skin or mucous membranes to provide a cooling and antipruritic effect. Without menthol, a moisturizing product is obtained; with menthol, a cooling product is produced.

[0016] A second aspect of the present invention provides a method for preparing a moisturizing eye composition.

[0017] A method for preparing a moisturizing eye-care composition includes the following steps:

[0018] (1) Take the solution containing soybean lecithin, which is solution A;

[0019] (2) Add retinyl palmitate liposome, lutein, oligomeric hyaluronic acid and ethylenediaminetetraacetic acid to water in sequence, mix and obtain solution B;

[0020] (3) Mix liquid A and liquid B to obtain the moisturizing eye-moisturizing composition.

[0021] Preferably, in step (1), the method for preparing the soy lecithin-containing solution is as follows: water is added to soy lecithin, and the mixture is heated and stirred at 80-90°C for 10-20 minutes to obtain the soy lecithin-containing solution. Heating helps the soy lecithin dissolve more quickly.

[0022] Preferably, in step (2), retinyl palmitate liposomes, polyethylene glycol 400, lutein, oligomeric hyaluronic acid, ethylenediaminetetraacetic acid, glycerin, sodium dihydrogen phosphate, and disodium hydrogen phosphate are added sequentially to water and stirred until completely dissolved to obtain solution B; or, retinyl palmitate liposomes, polyethylene glycol 400, lutein, oligomeric hyaluronic acid, menthol, ethylenediaminetetraacetic acid, glycerin, sodium dihydrogen phosphate, and disodium hydrogen phosphate are added sequentially to water and stirred until completely dissolved to obtain solution B.

[0023] A third aspect of the present invention provides an application of a moisturizing eye-care composition.

[0024] Application of a moisturizing eye-lubricating composition in the preparation of ophthalmic products.

[0025] A fourth aspect of the present invention provides an ophthalmic spray product.

[0026] An ophthalmic spray product comprising the aforementioned moisturizing eye-lubricating composition.

[0027] Preferably, the ophthalmic spray product is used by closing the eyes and then spraying the ophthalmic spray product onto the surface of the eyelids.

[0028] Currently, most eye care products are applied by directly dripping liquid into the eyeball. However, many people, especially children, are resistant to this method. Furthermore, when foreign objects enter the eye, the eyeball will reflexively blink to protect itself, resulting in wasted liquid and reduced treatment effectiveness. The ophthalmic spray product provided by this invention not only relieves dry and itchy eyes but also alleviates symptoms of eye strain, protects vision, and maintains normal visual acuity. Moreover, the spray application is gentle and non-irritating, increasing acceptability, minimizing liquid waste, and ensuring good treatment results.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] The moisturizing and eye-care composition provided by this invention uses a specific ratio of soybean lecithin, retinyl palmitate liposomes, lutein, oligomeric hyaluronic acid, and EDTA. The components can exert a good synergistic effect, improve the effect of relieving eye fatigue, protecting vision, and maintaining normal vision. It can improve the relief of dry and itchy eye symptoms caused by various reasons (such as fatigue, wearing contact lenses, using electronic products, and excessive eye use). Detailed Implementation

[0031] To enable those skilled in the art to more clearly understand the technical solutions described in this invention, the following embodiments are provided for illustration. It should be noted that the following embodiments do not constitute a limitation on the scope of protection claimed by this invention.

[0032] Unless otherwise specified, the raw materials, reagents or devices used in the following examples are available from conventional commercial sources or can be obtained by existing known methods.

[0033] The main sources of raw materials used in the embodiments and comparative examples of this invention are as follows:

[0034] Soy lecithin: Produced by Henan Siwei Biotechnology Co., Ltd., with a peroxide value ≤5.

[0035] Retinyl palmitate liposomes: produced by Guangzhou Zhongkang Pharmaceutical Technology Co., Ltd., with a pH value (1% aqueous solution, 20℃) of 6-7.

[0036] Lutein: Produced by Guangzhou Baoyi Biotechnology Co., Ltd., water-soluble, pH value 4.0-8.0.

[0037] Oligomeric HA: Produced by Dongying Fosite Biotechnology Co., Ltd., with an average relative molecular mass of <10 kDa.

[0038] PEG400: Produced by Xi'an Taihua Pharmaceutical Technology Co., Ltd., with an average molecular weight of 380-420 and an acidity of 4.0-7.0.

[0039] Polyoxyethylene 40 hydrogenated castor oil: BASF (China) Co. Ltd. Shanghai, maximum acid value 0.8 mg KOH / g.

[0040] EDTA: Produced by Chengdu Huayi Pharmaceutical Excipients Manufacturing Co., Ltd., pH value is 4.0-5.0.

[0041] Menthol: Produced by Guangzhou Fuyou New Material Technology Co., Ltd., water-soluble, pH value (1% aqueous solution, 20℃) is 5.5-8.5.

[0042] Example 1 (Moisturizing Type)

[0043] A moisturizing eye care composition comprising, by weight, the components shown in Table 1.

[0044] The preparation method of the above-mentioned moisturizing eye-care composition includes the following steps:

[0045] (1) Add water to soybean lecithin, heat and stir at 85±2℃ for 15 minutes to obtain solution A;

[0046] (2) Add retinyl palmitate liposome, PEG400, lutein, oligo HA, EDTA, glycerol, sodium dihydrogen phosphate monohydrate, and disodium hydrogen phosphate dodecahydrate to water in sequence and stir until completely dissolved to obtain solution B.

[0047] (3) Mix liquid A and liquid B to obtain a moisturizing eye-care composition with stable product performance.

[0048] Example 2 (Moisturizing Type)

[0049] A moisturizing eye care composition comprising, by weight, the components shown in Table 1.

[0050] The above-mentioned moisturizing and eye-care composition is the same as in Example 1.

[0051] Example 3 (Moisturizing Type)

[0052] A moisturizing eye care composition comprising, by weight, the components shown in Table 1.

[0053] The above-mentioned moisturizing and eye-care composition is the same as in Example 1.

[0054] Example 4 (Cooling Type)

[0055] A moisturizing eye care composition, which differs from Example 1 in that it contains 0.12 parts of menthol.

[0056] The preparation method of the above-mentioned moisturizing eye-care composition includes the following steps:

[0057] (1) Add water to soybean lecithin, heat and stir at 85±2℃ for 15 minutes to obtain solution A;

[0058] (2) Add retinyl palmitate liposome, PEG400, lutein, oligo HA, menthol, EDTA, glycerol, sodium dihydrogen phosphate monohydrate, and disodium hydrogen phosphate dodecahydrate to water in sequence and stir until completely dissolved to obtain solution B.

[0059] (3) Mix liquid A and liquid B to obtain the product, which has stable performance.

[0060] Example 5 (Cooling Type)

[0061] A moisturizing eye-care composition, differing from Example 2 in that it contains 10 parts menthol. The preparation method is the same as in Example 4.

[0062] Comparative Example 1

[0063] One composition, which differs from Example 1, is free of lutein.

[0064] Comparative Example 2

[0065] A composition that differs from Example 1 in that it does not contain retinyl palmitate liposomes.

[0066] Comparative Example 3

[0067] A composition differs from Example 1 in that the amount of soybean lecithin is reduced to 0.05 parts.

[0068] Comparative Example 4

[0069] A composition that differs from Example 1 in that PEG400 is replaced with an equal part by weight of PEG200.

[0070] Comparative Example 5

[0071] A composition that differs from Example 1 in that it does not contain oligomeric HA.

[0072] Comparative Example 6

[0073] A composition differs from Example 1 in that the amount of soybean lecithin is increased to 15 parts.

[0074] Comparative Example 7

[0075] A composition that differs from Example 1 in that oligomeric hyaluronic acid is replaced with an equal part by weight of hyaluronic acid.

[0076] Comparative Example 8

[0077] A composition, differing from Example 1 in that the preparation method is changed as follows:

[0078] (1) Add water to soybean lecithin, heat and stir at 85°C for 15 minutes, then add retinyl palmitate liposomes and lutein to obtain solution A;

[0079] (2) Add PEG400, oligo HA, EDTA, glycerol, sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate dodecahydrate to water in sequence and stir until completely dissolved to obtain solution B;

[0080] (3) Mix liquid A and liquid B to obtain a composition.

[0081] The components and their amounts in each embodiment are shown in Table 1 below:

[0082] Table 1. Components and their amounts (parts by weight) for each embodiment.

[0083]

[0084]

[0085] Product effectiveness test

[0086] 130 patients with dry, itchy, and fatigued eyes due to video terminals were screened. These patients met the diagnostic criteria of the "Expert Consensus on the Diagnosis and Treatment of Visual Fatigue (2014)" and experienced symptoms such as itchy, dry, and itchy eyes after prolonged use of electronic products such as computers, mobile phones, and televisions. They were randomly divided into 13 groups of 10 patients each. The effects of different implementation examples and comparative examples of the products were tested. Patients were aged 18-40 years and used video terminals continuously for more than 5 hours per day. All patients provided informed consent. Exclusion criteria: (1) patients with eye fatigue due to other causes; (2) patients with other eye diseases; (3) patients who received related treatments within 2 weeks prior to enrollment; (4) patients allergic to any component of the product; (5) patients with mental disorders; (6) pregnant or lactating women.

[0087] Product usage instructions: Use with eyes closed. Keep your eyes closed and maintain a distance of about 10cm. Spray the product onto your eyelids 1-2 times each time, 3-4 times a day.

[0088] Ocular symptom scoring criteria: Before treatment and 4 weeks after treatment, the ocular symptoms (including dry eyes, eye irritation, and eye fatigue) of each group of patients were scored on a 4-level scale according to the severity. The scores were as follows: 0 points for no symptoms, 2 points for mild symptoms, 4 points for moderate symptoms, and 6 points for severe symptoms.

[0089] Visual acuity test: The patient's visual acuity was tested before and after treatment. The treatment period was 4 weeks. The specific method was as follows: the pupils were dilated with compound tropicamide. Half an hour later, refractive tests were performed using an optometry device.

[0090] Statistical methods used SPSS 22.0 statistical data; quantitative methods used... The results indicate that chi-square and t-tests were performed respectively; P < 0.05 was considered statistically significant.

[0091] Table 2. Effect test results of each embodiment and comparative example.

[0092]

[0093]

[0094] As shown in the table above, the moisturizing and eye-nourishing compositions provided in Examples 1-5 of this invention have significant effects in relieving dry eyes, eye strain, and eye fatigue. They help alleviate eye symptoms, increase patient eye comfort, and can be used for symptoms such as dry eyes and eye strain caused by fatigue, wearing contact lenses, using electronic products, and excessive eye use. In addition, they can protect vision, maintain normal visual function, and have a certain protective effect on vision, and can even achieve a certain improvement effect (uncorrected visual acuity is improved after treatment). They are also convenient to use, inexpensive, and safe, and can be widely used.

[0095] Compared with Example 1, Comparative Example 1 and Comparative Example 2 did not contain lutein and retinyl palmitate liposomes, respectively, resulting in a significant decrease in the effect of relieving dry eyes, eye irritation and eye fatigue, and no significant effect on protecting vision.

[0096] Compared with Example 1, Comparative Example 3 reduced the amount of soybean lecithin, making it difficult for it to interact with other components. This resulted in a significant decrease in its ability to relieve dry eyes, eye irritation, and eye fatigue, and it failed to protect vision. Long-term use of the composition of Comparative Example 3 may even lead to a decline in vision if the discomfort symptoms (dry eyes, eye irritation, and eye fatigue) are not relieved.

[0097] Compared with Example 1, Comparative Example 4 replaced PEG400 with an equal weight of PEG200, resulting in a significant decrease in the effect of relieving dry eyes, eye irritation and eye fatigue, and failing to protect vision.

[0098] Compared with Example 1, Comparative Example 5 does not contain oligomeric HA, resulting in a significant decrease in its ability to relieve dry eyes, eye strain and eye fatigue, and it does not play a role in protecting vision.

[0099] Compared with Example 1, Comparative Example 6 increased the amount of soybean lecithin, which resulted in the inability to be quickly absorbed through the skin and exert its effect. Therefore, the effect of relieving dry eyes, eye irritation and eye fatigue was significantly reduced, and it failed to protect vision.

[0100] Compared to Example 1, Comparative Example 7, which replaced oligomeric HA with an equal weight of HA, showed a significant decrease in its effect of relieving dry eyes, eye irritation, and eye fatigue. HA has a large molecular weight (the weight-average molecular weight of HA is 500-730 kDa, while the average relative molecular mass of oligomeric HA is <10 kDa), whereas the oligomeric HA used in Example 1 has a much smaller molecular weight. This not only eliminates sunlight-induced reactive oxygen species, enhancing cellular antioxidant capacity, but also improves the skin's defense against UVB. Furthermore, it possesses bioactivity, can be better absorbed through the eyelids, has good moisturizing effects, and can synergistically work with other components to enhance the relief of dry eyes, eye irritation, and eye fatigue. Moreover, it did not protect vision. Long-term use of the composition in Comparative Example 7, without relief of eye discomfort symptoms (dry eyes, eye irritation, and eye fatigue), could even lead to decreased vision.

[0101] Compared with Example 1, Comparative Example 8 changed the mixing method of the components. Since retinyl palmitate liposomes and lutein are not heat-resistant, they will be degraded at this temperature and lose their original properties. As a result, the composition’s effect of relieving dry eyes, eye irritation and eye fatigue is significantly reduced, and it also fails to protect vision.

Claims

1. A moisturizing eye-care composition, characterized in that, It consists of the following components in parts by weight: Soybean lecithin 0.1-10 parts, retinyl palmitate liposomes 1-5 parts, lutein 1.2-5 parts, oligomeric hyaluronic acid 0.1-10 parts, ethylenediaminetetraacetic acid 0.01-10 parts, polyoxyethylene 40 hydrogenated castor oil 0.2-5 parts, polyethylene glycol 400 0.2-5 parts, glycerin 1-5 parts, sodium dihydrogen phosphate 0.042-3 parts, disodium hydrogen phosphate 0.25-10 parts, menthol 0.12-10 parts, and water 80-100 parts; Oligomeric hyaluronic acid has an average relative molecular mass of <10 kDa; The moisturizing and eye-moisturizing composition is prepared by a method comprising the following steps: (1) Add water to soybean lecithin and heat and stir at 80-90℃ for 10-20 minutes to obtain a solution containing soybean lecithin, which is solution A; (2) Add retinyl palmitate liposome, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, oligomeric hyaluronic acid, menthol, ethylenediaminetetraacetic acid, glycerol, sodium dihydrogen phosphate and disodium hydrogen phosphate to water in sequence, and stir until completely dissolved to obtain solution B. (3) Mix liquid A and liquid B to obtain the moisturizing eye-moisturizing composition.

2. A moisturizing eye-care composition, characterized in that, It consists of the following components in parts by weight: 0.1 parts soybean lecithin, 1 part retinyl palmitate liposome, 1.2 parts lutein, 0.1 parts oligomeric hyaluronic acid, 0.01 parts ethylenediaminetetraacetic acid, 0.2 parts polyoxyethylene 40 hydrogenated castor oil, 0.2 parts polyethylene glycol 400, 1 part glycerin, 0.042 parts sodium dihydrogen phosphate, 0.25 parts disodium hydrogen phosphate, and 80 parts water; Oligomeric hyaluronic acid has an average relative molecular mass of <10 kDa; The moisturizing and eye-moisturizing composition is prepared by a method comprising the following steps: (1) Add water to soybean lecithin and heat and stir at 80-90℃ for 10-20 minutes to obtain a solution containing soybean lecithin, which is solution A; (2) Add retinyl palmitate liposome, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, oligomeric hyaluronic acid, ethylenediaminetetraacetic acid, glycerol, sodium dihydrogen phosphate and disodium hydrogen phosphate to water in sequence, and stir until completely dissolved to obtain solution B. (3) Mix liquid A and liquid B to obtain the moisturizing eye-moisturizing composition.

3. A moisturizing eye-care composition, characterized in that, It consists of the following components in parts by weight: 10 parts soybean lecithin, 5 parts retinyl palmitate liposomes, 5 parts lutein, 10 parts oligo-hyaluronic acid, 10 parts ethylenediaminetetraacetic acid, 5 parts polyoxyethylene 40 hydrogenated castor oil, 5 parts polyethylene glycol 400, 5 parts glycerin, 3 parts sodium dihydrogen phosphate, 10 parts disodium hydrogen phosphate, and 100 parts water. Oligomeric hyaluronic acid has an average relative molecular mass of <10 kDa; The moisturizing and eye-moisturizing composition is prepared by a method comprising the following steps: (1) Add water to soybean lecithin and heat and stir at 80-90℃ for 10-20 minutes to obtain a solution containing soybean lecithin, which is solution A; (2) Add retinyl palmitate liposome, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, oligomeric hyaluronic acid, ethylenediaminetetraacetic acid, glycerol, sodium dihydrogen phosphate and disodium hydrogen phosphate to water in sequence, and stir until completely dissolved to obtain solution B. (3) Mix liquid A and liquid B to obtain the moisturizing eye-moisturizing composition.

4. A moisturizing eye-care composition, characterized in that, It consists of the following components in parts by weight: 5 parts soybean lecithin, 3 parts retinyl palmitate liposomes, 3 parts lutein, 5 parts oligomeric hyaluronic acid, 5 parts ethylenediaminetetraacetic acid, 3 parts polyoxyethylene 40 hydrogenated castor oil, 3 parts polyethylene glycol 400, 3 parts glycerin, 1.5 parts sodium dihydrogen phosphate, 5 parts disodium hydrogen phosphate, and 90 parts water. Oligomeric hyaluronic acid has an average relative molecular mass of <10 kDa; The moisturizing and eye-moisturizing composition is prepared by a method comprising the following steps: (1) Add water to soybean lecithin and heat and stir at 80-90℃ for 10-20 minutes to obtain a solution containing soybean lecithin, which is solution A; (2) Add retinyl palmitate liposome, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, oligomeric hyaluronic acid, ethylenediaminetetraacetic acid, glycerol, sodium dihydrogen phosphate and disodium hydrogen phosphate to water in sequence, and stir until completely dissolved to obtain solution B. (3) Mix liquid A and liquid B to obtain the moisturizing eye-moisturizing composition.

5. The method for preparing the moisturizing eye-nourishing composition according to claim 1, characterized in that, Includes the following steps: (1) Add water to soybean lecithin and heat and stir at 80-90℃ for 10-20 minutes to obtain a solution containing soybean lecithin, which is solution A; (2) Add retinyl palmitate liposome, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, oligomeric hyaluronic acid, menthol, ethylenediaminetetraacetic acid, glycerol, sodium dihydrogen phosphate and disodium hydrogen phosphate to water in sequence, and stir until completely dissolved to obtain solution B. (3) Mix liquid A and liquid B to obtain the moisturizing eye-moisturizing composition.

6. The use of the moisturizing and eye-moisturizing composition according to any one of claims 1-4 in the preparation of ophthalmic articles.

7. An ophthalmic spray product comprising the moisturizing eye-lubricating composition according to any one of claims 1-4.

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