Moisturizing eye-moistening liquid as well as preparation method and application thereof

Abstract

The invention discloses a moisturizing eye lotion as well as a preparation method and application thereof, and relates to the technical field of eye care compositions. The eye moistening liquid is prepared from, by mass, 0.0005%-0.001% of xanthophyll, 0%-0.01% of taurine, 0.001%-0.01% of allantoin and 0%-0.01% of cowberry / eyesight improving grass / fructus lycii extract, a wetting agent, an emulsifying agent and a preservative are matched, various active ingredients synergistically relieve dry eyes, eye astringency and asthenopia, and the stability is guaranteed through the process that the active ingredients are dissolved and mixed step by step and then added. The eye-closing spray is used in the form of eye-closing spray, fog drops diffuse into eyes through eyelids, and direct stimulation is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of eye care compositions, in particular to a moisturizing eye drop and a preparation method and application thereof. BACKGROUND

[0002] With the popularity of electronic devices and the increase in eye use, dry eye and visual fatigue have become a global high-incidence eye problem. Traditional eye drops mainly temporarily relieve the symptoms of dry eyes by supplementing water or viscous substances, but still have the shortcomings of single function, low bioavailability and poor user experience.

[0003] Most eye drop products on the market rely only on sodium hyaluronate, glycerol and other moisturizers, and lack active ingredients for retinal protection and improvement. Commonly added plant extracts are prone to precipitation and uneven dispersion in conventional water-based systems due to high liposolubility, resulting in reduced efficacy.

[0004] Current eye drops are of the direct eye drop type, which can easily cause irritation reflex and blinking response, reducing user compliance. In recent years, although spray-type eye products have appeared, there are still problems such as simple ingredient combination, insufficient emulsion stability, etc., making it difficult to simultaneously achieve long-term moisturizing, anti-fatigue and vision protection functions. Therefore, there is an urgent need to develop an eye care solution with multiple components, friendly dosage form and high bioavailability. SUMMARY

[0005] The purpose of the present application is to provide a moisturizing eye drop and a preparation method and application thereof, which can not only effectively relieve dry eyes and eye dryness, but also reduce visual fatigue and visual blurring, and have the function of protecting vision.

[0006] The present application provides the following technical solutions:

[0007] A moisturizing eye drop, comprising the following components by mass percentage:

[0008] Lutein 0.0005% to 0.001%;

[0009] Taurine 0% to 0.01%;

[0010] Allantoin 0.001% to 0.01%;

[0011] Blueberry extract 0% to 0.01%;

[0012] Euphrasia officinalis extract 0% to 0.01%;

[0013] Medlar extract 0% to 0.01%.

[0014] Lutein as the core pigment in the macular region of the retina can filter harmful blue light, reduce oxidative damage, and delay macular degeneration; taurine promotes ocular blood circulation, regulates tear status, and enhances tear film stability; allantoin repairs ocular surface damage, promotes cell regeneration, and forms a protective film; anthocyanins in bilberry extract can improve microcirculation and relieve ciliary spasm; and eyebright and medlar extract synergistically enhance antioxidant capacity, improve nutrient supply, and relieve eye discomfort.

[0015] Further, the moisturizing eye drop composition further comprises ergothioneine, a humectant, an emulsifier, menthol, a preservative, and water.

[0016] Further, the humectant is one or more of sodium hyaluronate, glycerol, and polyethylene glycol 400.

[0017] Further, the emulsifier is one or more of polyoxyethylene 40 hydrogenated castor oil and soybean lecithin.

[0018] Further, the preservative is one or more of edetate disodium and benzalkonium chloride.

[0019] Further, the sodium hyaluronate is 0.005% to 0.02%, the glycerol is 0.5% to 1.0%, the polyethylene glycol 400 is 0.1% to 0.5%, the polyoxyethylene 40 hydrogenated castor oil is 0.1% to 0.5%, the soybean lecithin is 0.005% to 0.05%, the menthol is 0% to 0.06%, the edetate disodium is 0.005% to 0.01%, the benzalkonium chloride is 0.003% to 0.01%, and the ergothioneine is 0% to 0.01% by mass percentage.

[0020] Sodium hyaluronate, glycerol, and polyethylene glycol 400 are the moisturizing core of the composition, and the components synergistically enhance the moisturizing effect. Polyoxyethylene 40 hydrogenated castor oil and soybean lecithin ensure uniform dispersion of all ingredients, avoiding stratification or precipitation. The menthol is dispersed in the system after being solubilized by polyoxyethylene 40 hydrogenated castor oil and soybean lecithin, which can bring a "cooling sensation" to the user and relieve dryness and astringency of the eyes. The traditional Chinese medicine extract contains various active ingredients, which are solubilized and dispersed by polyoxyethylene 40 hydrogenated castor oil and soybean lecithin. The penetration-promoting effect of soybean lecithin can help the active ingredients better contact mucosal cells and exert efficacy. Edetate disodium can combine with metal ions to form stable chelates, avoiding interference with the system and prolonging product stability. Benzalkonium chloride prevents product deterioration by "inhibiting microorganisms", and both of them together guarantee the "chemical stability" and "microbial safety" of the system.

[0021] The application provides a preparation method of a moisturizing eye drop, which comprises the following steps:

[0022] (1) Sodium hyaluronate is added to purified water, and stirred at room temperature for 15-20 min to prepare A liquid;

[0023] (2) Glycerin, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, soybean lecithin are weighed in turn, and ultrasonic stirring is carried out for 1 h until complete dissolution to obtain B liquid; or glycerin, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, soybean lecithin, menthol are ultrasonically stirred for 1 h until complete dissolution to obtain B liquid;

[0024] (3) After mixing A liquid and B liquid, taurine, allantoin, bilberry extract, eyebright extract, wolfberry extract, disodium edetate and benzalkonium chloride are added in turn and uniformly mixed to obtain the moisturizing eye drop composition.

[0025] Further, the moisturizing eye drop composition is used for relieving visual fatigue.

[0026] The application provides a moisturizing eye drop composition eye spray product, which comprises the moisturizing eye drop composition.

[0027] Further, the use method of the eye spray product is to use it with eyes closed and spray it on eyelids and around eyes.

[0028] At present, most eye preparations are directly dropped into eyes, and eyes have high sensitivity to external substances, so the compliance and adherence of users are poor, and the experience is not good. The eye spray provided by the application can not only relieve dry eyes, eye dryness, visual fatigue, reduce visual blurring and protect vision, but also can form very small mist droplets by spraying on the ocular surface and around the eyes, and the mist droplets can enter the eyes by blinking, so the compliance is high and the experience is comfortable.

[0029] Compared with the prior art, the application has the beneficial effects that:

[0030] 1. The synergistic effect of lutein, taurine, allantoin and traditional Chinese medicine extracts can effectively relieve dry eyes, eye dryness, visual fatigue, protect vision and reduce visual blurring.

[0031] 2. The spray type avoids the irritation caused by direct eye drops, and improves the compliance and comfort of use.

[0032] 3. The micelles formed by polyoxyethylene 40 hydrogenated castor oil and soybean lecithin solubilize part of the fat-soluble ingredients such as lutein, avoid precipitation problems and ensure uniform dispersion of active ingredients. DETAILED DESCRIPTION

[0033] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0034] The present invention does not limit the source of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are all commercially available products in this technical field.

[0035] Example 1

[0036] A moisturizing eye care composition, the composition and dosage of which are shown in Table 1, is prepared as follows:

[0037] (1) Add sodium hyaluronate to water and stir at room temperature for 15 minutes to obtain solution A;

[0038] (2) Weigh out glycerin, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, soybean lecithin and menthol, and sonicate and stir for 1 hour until completely dissolved to obtain solution B;

[0039] (3) After mixing solution A and solution B, add taurine, allantoin, blueberry extract, ginseng extract, wolfberry extract, disodium edetate and benzalkonium chloride in sequence and mix evenly to obtain a moisturizing eye-care composition.

[0040] Example 2

[0041] The composition and dosage of Example 2 are shown in Table 1, and the specific preparation method is the same as that of Example 1.

[0042] Example 3

[0043] The difference between Example 3 and Example 1 is that menthol, taurine, and the extract were omitted. The remaining components and amounts are shown in Table 1. The specific preparation method is as follows:

[0044] (1) Add sodium hyaluronate to water and stir at room temperature for 15 minutes to obtain solution A;

[0045] (2) Weigh out glycerin, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein and soybean lecithin, and ultrasonically stir for 1 hour until completely dissolved to obtain solution B;

[0046] (3) After mixing solution A and solution B, add allantoin, disodium edetate and benzalkonium chloride in sequence and mix evenly to obtain a moisturizing eye-moisturizing composition.

[0047] Example 4

[0048] The difference between Example 4 and Example 1 is that menthol, taurine, and traditional Chinese medicine extracts were removed, and ergothioneine was added. The remaining components and dosages are shown in Table 1. The specific preparation method is as follows:

[0049] (1) Add sodium hyaluronate to water and stir at room temperature for 15 minutes to obtain solution A;

[0050] (2) Weigh out glycerin, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein and soybean lecithin, and ultrasonically stir for 1 hour until completely dissolved to obtain solution B;

[0051] (3) After mixing solution A and solution B, add ergothioneine, allantoin, disodium edetate and benzalkonium chloride in sequence and mix evenly to obtain a moisturizing eye-moisturizing composition.

[0052] Comparative Example 1

[0053] The difference between Comparative Example 1 and Example 1 is that Comparative Example 1 does not contain lutein, while the other components and dosages are the same as in Example 1.

[0054] Comparative Example 2

[0055] The difference between Comparative Example 2 and Example 1 is that it does not contain taurine, while the other components and amounts are the same as in Example 1.

[0056] Comparative Example 3

[0057] The difference between Comparative Example 3 and Example 1 is that it does not contain allantoin, while the other components and dosages are the same as in Example 1.

[0058] Comparative Example 4

[0059] The difference between Comparative Example 4 and Example 1 is that the amount of polyethylene glycol 400 is increased to 0.2%, while the other components and amounts are the same as in Example 1.

[0060] Comparative Example 5

[0061] The difference between Comparative Example 5 and Example 1 is that the amount of polyethylene glycol 400 and polyoxyethylene 40 hydrogenated castor oil is increased to 0.2%, while the remaining composition and amount are the same as in Example 1.

[0062] Comparative Example 6

[0063] The difference between Comparative Example 6 and Example 1 is that the amount of sodium hyaluronate is increased to 0.1%, while the other components and amounts are the same as in Example 1.

[0064] Table 1. Amounts of components used in Examples 1-4 (by mass fraction, unit: %)

[0065]

[0066] Product effectiveness test

[0067] Sixty patients with dry, itchy, and fatigued eyes were selected as subjects. They met the diagnostic criteria of the "Chinese Expert Consensus on the Diagnosis and Treatment of Visual Fatigue (2024)". All of them had visual impairment and eye discomfort due to various factors causing the human eye to see objects beyond its visual capacity, with or without systemic symptoms. They were randomly divided into 3 groups of 20 people in each group, aged 12-60 years, and all patients gave informed consent. Exclusion criteria: (1) patients with eye diseases; (2) patients who had been exposed to relevant tests in the two weeks prior to enrollment; (3) patients who were allergic to the ingredients of this product; (4) patients with mental disorders; (5) women who were pregnant or lactating.

[0068] How to use: Use with eyes closed, about 10cm away from the eyes, spray on the eyelids and around the eyes, spray 1-2 times, 3-4 times a day.

[0069] Ocular symptom scoring criteria: Before treatment and 4 weeks after treatment, the ocular symptoms (dry eyes, soreness, stinging, foreign body sensation, blurred vision, photophobia, tearing, heavy eyelids) of each group of patients were scored on a 4-level scale according to the severity. Among them, no symptoms were 0 points, mild symptoms were 2 points, moderate symptoms were 4 points, and severe symptoms were 6 points.

[0070] Statistical methods used SPASS data; measurements were expressed in parentheses (), and chi-square and t-tests were performed respectively; P < 0.05 was considered statistically significant.

[0071]

[0072] Note: Compared with before treatment, P<0.05; data are expressed as mean ± standard deviation.

[0073] Example 1 showed the best overall improvement effect. After treatment, the scores of dry eyes, eye irritation and eye fatigue all decreased significantly (all P<0.01), indicating that its complete formula (containing lutein, taurine, Chinese herbal extracts and menthol) has a significant synergistic effect in relieving various eye discomfort symptoms, and the cooling sensation also helps to provide immediate relief.

[0074] Example 4 showed particularly outstanding performance in relieving dry and itchy eyes, with no statistically significant difference compared to Example 1 (P>0.05). This indicates that ergothioneine, as a highly effective antioxidant and cell protectant, makes a significant contribution to enhancing the moisturizing and repair of the ocular surface, making it suitable for users who are sensitive to a cooling sensation or who prioritize long-lasting repair.

[0075] The improvement in symptoms in Comparative Example 1 was far less than that in Examples 1 and 4, confirming the indispensable role of lutein in filtering blue light, protecting the retina, and fundamentally reducing eye strain.

[0076] The effects of Comparative Examples 4–6 were also inferior to those of the Examples, indicating that the formulation ratios described in this invention have the best synergistic effect in terms of moisturizing, stability and bioavailability.

[0077] In the moisturizing eye drops provided by this invention, Examples 1 and 4 both exhibited the best and most similar symptom-relieving abilities, significantly outperforming the control formula lacking the key ingredient. This demonstrates the scientific validity and synergistic effect of this patented formula, while providing equally effective options for different user preferences.

Claims

1. A moisturizing eye drop, characterized by comprising: By mass percentage, the following components are included: Lutein 0.0005%~0.001%; Taurine 0%~0.01%; Allantoin 0.001%~0.01%; Blueberry extract 0%~0.01%; Eyebright extract 0%~0.01%; Medlar extract 0%~0.01%.

2. The moisturizing eye drops according to claim 1, wherein The moistening eye composition further includes ergothioneine, humectants, emulsifiers, menthol, preservatives, and water.

3. The moisturizing eye drops according to claim 2, wherein The humectants are one or more of sodium hyaluronate, glycerol, and polyethylene glycol 400.

4. The moisturizing eye drops of claim 2, wherein The emulsifiers are one or more of polyoxyethylene 40 hydrogenated castor oil and soybean lecithin.

5. The moisturizing eye drops of claim 2, wherein The preservatives are one or more of disodium edetate and benzalkonium chloride.

6. The moisturizing eye drops of claim 2, wherein By mass percentage, the sodium hyaluronate is 0.005%~0.02%, the glycerol is 0.5%~1.0%, the polyethylene glycol 400 is 0.1%~0.5%, the polyoxyethylene 40 hydrogenated castor oil is 0.1%~0.5%, the soybean lecithin is 0.005%~0.05%, the menthol is 0%~0.06%, the disodium edetate is 0.005%~0.01%, the benzalkonium chloride is 0.003%~0.01%, and the ergothioneine is 0%~0.01%.

7. A method of preparing a moisturizing eye drop, characterized by, The method comprises the following steps: (1) adding sodium hyaluronate into purified water, stirring at room temperature for 15-20 min to prepare A liquid; (2) weighing glycerol, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, and soybean lecithin in sequence, and stirring for 1 h under ultrasonic waves until completely dissolved to obtain B liquid; or, weighing glycerol, polyethylene glycol 400, polyoxyethylene 40 hydrogenated castor oil, lutein, soybean lecithin, and menthol in sequence, and stirring for 1 h under ultrasonic waves until completely dissolved to obtain B liquid; (3) mixing A liquid and B liquid, and then adding taurine, allantoin, blueberry extract, eyebright extract, medlar extract, disodium edetate, and benzalkonium chloride in sequence, and mixing uniformly to obtain the moistening eye composition.

8. Use of the moistening eye composition according to any one of claims 1-6 or prepared by the method of claim 7 in relieving visual fatigue.

9. An eye spray product comprising the moistening eye composition according to any one of claims 1-6.

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