Protein-containing moisturizing eye drops and preparation method thereof

Abstract

The invention provides a protein-containing moisturizing eye lotion and a preparation method thereof, and belongs to the technical field of eye lotions. The protein-containing moisturizing eye drops disclosed by the invention are prepared from the following components in percentage by mass: 0.05 to 0.3 percent of human-derived III type collagen, 0.05 to 0.3 percent of plant extract, 0.1 to 0.5 percent of humectant, 0.05 to 0.12 percent of taurine, 0.5 to 1.5 percent of osmotic pressure regulator, 0.3 to 1 percent of stabilizer, 0.5 to 1.5 percent of pH regulator and the balance of water. The human-derived III-type collagen, the plant extract, the taurine and the humectant are combined, so that the eye lotion has an excellent moisturizing effect and is free of irritation and discomfort, and the long-acting moisturizing and soothing effects of the eye lotion are achieved together with the osmotic pressure regulator, the stabilizer and the pH regulator.

Description

Technical Field

[0001] This invention relates to the field of eye drops technology, and more particularly to a protein-containing moisturizing eye drop and its preparation method. Background Technology

[0002] With increasing work pressure and the rapid development of electronic products, people are spending more and more time using computers, mobile phones, and other electronic devices, leading to increasingly common symptoms such as dry eyes, eye fatigue, and eye inflammation in daily life. Myopia is becoming more prevalent, and some people wear contact lenses for aesthetic reasons. After wearing contact lenses, eyes may experience fatigue, dryness, and bacterial invasion. These eye symptoms often require the relief of moisturizing eye drops. Currently, commonly used moisturizing and lubricating factors include hyaluronic acid, sodium pyrrolidone carboxylate, polyvinyl alcohol, glycerin, propylene glycol, and sorbitol, which can provide soothing and moisturizing effects, reduce redness and fatigue. Polyvinyl alcohol is a soluble resin that can irritate the eyes. Sodium pyrrolidone carboxylate is a natural moisturizer with excellent hygroscopic properties, stronger than traditional moisturizers such as glycerin, propylene glycol, and sorbitol. Hyaluronic acid is a high-molecular-weight polysaccharide, a major component of many connective tissues in the human body, and has excellent water-retention properties, making it an ideal natural moisturizing factor. However, the existing eye drops containing hyaluronic acid are far from sufficient in terms of long-lasting moisturizing performance and relief of dry eyes.

[0003] Therefore, it is of great significance to provide an eye drop that relieves dry eyes, provides long-lasting hydration, and is safe and non-irritating. Summary of the Invention

[0004] The purpose of this invention is to provide a protein-containing moisturizing eye drop and its preparation method, addressing the shortcomings of existing technologies.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a protein-containing moisturizing eye drop, which comprises the following components by mass fraction: 0.05-0.3% human type III collagen, 0.05-0.3% plant extract, 0.1-0.5% humectant, 0.05-0.12% taurine, 0.5-1.5% osmotic pressure regulator, 0.3-1% stabilizer, 0.5-1.5% pH adjuster, and the remainder being water.

[0006] Preferably, the human type III collagen has a molecular weight of 20-30 kDa.

[0007] Preferably, the plant extract is blueberry extract and / or chamomile extract.

[0008] Preferably, the blueberry extract is obtained by enzymatic hydrolysis with a complex glycosidase, which is a mixture of β-D-glucosidase and α-L-arabinosidase in a mass ratio of 1 to 3:1.

[0009] Preferably, the enzymatic hydrolysis temperature is 35~45℃ and the enzymatic hydrolysis time is 6~8h.

[0010] Preferably, the moisturizer is one or more of hydroxypropyl methylcellulose, hyaluronic acid, and sodium hyaluronate.

[0011] Preferably, the osmotic pressure regulator is sodium chloride and / or potassium chloride.

[0012] Preferably, the stabilizer is hydroxypropyl-β-cyclodextrin and / or hydroxypropyl methylcellulose.

[0013] Preferably, the pH adjuster is boric acid and borax, and the mass ratio of boric acid to borax is 2~4:1~3.

[0014] The present invention also provides a method for preparing the protein-containing moisturizing eye drop, comprising the following steps: mixing plant extracts, moisturizers, taurine, stabilizers and water, then adding osmotic pressure regulators and pH regulators and mixing, and finally adding human type III collagen and mixing to obtain a protein-containing moisturizing eye drop.

[0015] The beneficial effects of this invention are: 1) Blueberry extract contains active ingredients such as anthocyanins and flavonoids, which can provide moisturizing and soothing effects to the ocular mucosa, relieve dry eyes, foreign body sensation, and eye fatigue; anthocyanins also have antioxidant effects, reducing free radical damage to the ocular surface and retina, and helping to improve eye fatigue; Chamomile extract contains apigenin, chamomile glycosides, flavonols, and other components, which can inhibit mild inflammatory reactions of the ocular mucosa, and its polysaccharide components can form a thin hydrating film on the ocular surface, locking in moisture, increasing ocular surface hydration, and relieving dryness.

[0016] 2) Human type III collagen has the characteristics of strong water solubility and high biological activity, which can effectively replenish the missing collagen, promote tissue cell regeneration, and fundamentally improve the eye environment.

[0017] 3) Taurine can improve the microcirculation and metabolism of eye tissues, reduce eye fatigue caused by prolonged use of the eyes, and increase the moisture of the eye surface to relieve discomfort such as dryness, soreness, and foreign body sensation. It also has a certain antioxidant effect, which can remove free radicals generated in the eyes due to metabolism and external stimuli (such as blue light and ultraviolet rays), reduce oxidative damage, and at the same time have a certain protective effect on retinal ganglion cells.

[0018] 4) The combination of human type III collagen, plant extracts, taurine, and moisturizer in this invention has excellent moisturizing effects and is free from irritation and discomfort. Together with osmotic pressure regulators, stabilizers, and pH adjusters, it achieves long-lasting moisturizing and soothing effects for eye drops. Detailed Implementation

[0019] This invention provides a protein-containing moisturizing eye drop, comprising the following components by mass fraction: 0.05-0.3% human type III collagen, 0.05-0.3% plant extract, 0.1-0.5% moisturizer, 0.05-0.12% taurine, 0.5-1.5% osmotic pressure regulator, 0.3-1% stabilizer, 0.5-1.5% pH adjuster, and the remainder being water.

[0020] In the protein-containing moisturizing eye drop of the present invention, human type III collagen is preferably 0.1-0.25%, more preferably 0.15-0.2%; plant extract is preferably 0.1-0.25%, more preferably 0.15-0.2%; moisturizer is preferably 0.2-0.4%, more preferably 0.3%; taurine is preferably 0.06-0.1%, more preferably 0.07-0.08%; osmotic pressure regulator is preferably 0.8-1.2%, more preferably 0.9-1%; stabilizer is preferably 0.5-0.8%, more preferably 0.6-0.7%; and pH adjuster is preferably 0.8-1.2%, more preferably 0.9-1%.

[0021] In this invention, the molecular weight of the human type III collagen is preferably 20-30 kDa, more preferably 22-28 kDa, and even more preferably 24-26 kDa.

[0022] In this invention, the plant extract is preferably blueberry extract and / or chamomile extract.

[0023] In this invention, the blueberry extract is preferably obtained by enzymatic hydrolysis with a complex glycosidase. The complex glycosidase is preferably a mixture of β-D-glucosidase and α-L-arabinosidase in a mass ratio of 1 to 3:1, and more preferably a mixture of β-D-glucosidase and α-L-arabinosidase in a mass ratio of 2:1.

[0024] In this invention, the enzymatic hydrolysis temperature is preferably 35~45℃, more preferably 37~42℃, and even more preferably 40℃, and the enzymatic hydrolysis time is preferably 6~8h, more preferably 6.5~7.5h, and even more preferably 7h.

[0025] In this invention, the moisturizer is preferably one or more of hydroxypropyl methylcellulose, hyaluronic acid, and sodium hyaluronate.

[0026] In this invention, the osmotic pressure regulator is preferably sodium chloride and / or potassium chloride.

[0027] In this invention, the stabilizer is preferably hydroxypropyl-β-cyclodextrin and / or hydroxypropyl methylcellulose; hydroxypropyl-β-cyclodextrin and hydroxypropyl methylcellulose have both stabilizing and moisturizing functions.

[0028] In this invention, the pH adjuster is preferably boric acid and borax, and the mass ratio of boric acid to borax is preferably 2~4:1~3, more preferably 3:2.

[0029] The present invention also provides a method for preparing the protein-containing moisturizing eye drop, comprising the following steps: mixing plant extracts, moisturizers, taurine, stabilizers and water, then adding osmotic pressure regulators and pH regulators and mixing, and finally adding human type III collagen and mixing to obtain a protein-containing moisturizing eye drop.

[0030] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0031] In the examples and comparative examples, the chamomile extract was prepared using dried chamomile flowers as raw material and by methods well known in the art; the molecular weight of human type III collagen was 24-26 kDa.

[0032] Example 1

[0033] 300g of dried and pulverized blueberry powder was added to 12.5L of ethanol (70% by mass) and ultrasonically extracted at 250W frequency and 60℃ for 30min. After rotary evaporation and drying, 5 times the mass of deionized water was added, and the pH was adjusted to 5.5 with 1mol / L hydrochloric acid. A complex glycosidase, a mixture of β-D-glucosidase and α-L-arabinosidase in a mass ratio of 1~3:1, was added at 8000U / g of blueberry powder. Enzymatic hydrolysis was carried out at 40℃ for 8h, followed by enzyme inactivation at 90℃ for 15min. The enzymatic hydrolysis product was filtered, rotary evaporated, dried, and pulverized to obtain the blueberry extract.

[0034] The protein-containing moisturizing eye drops are prepared from the following components by mass fraction: 0.15% human type III collagen, 0.2% blueberry extract, 0.3% moisturizer (sodium hyaluronate, molecular weight 180~200kDa), 0.08% taurine, 1% osmotic pressure regulator (sodium chloride), 0.7% stabilizer (hydroxypropyl methylcellulose K100M), 1% pH adjuster (boric acid and borax in a mass ratio of 3:2), and the remainder is deionized water.

[0035] Blueberry extract, moisturizer, taurine, stabilizer and deionized water are mixed evenly, then osmotic pressure regulator and pH regulator are added and mixed evenly, and finally human type III collagen is added and mixed evenly to obtain a protein-containing moisturizing eye drop.

[0036] Example 2

[0037] The preparation process of the blueberry extract is the same as in Example 1.

[0038] The protein-containing moisturizing eye drops are prepared from the following components by mass fraction: 0.2% human type III collagen, 0.15% blueberry extract, 0.4% humectant (hydroxypropyl methylcellulose K100M), 0.06% taurine, 1.2% osmotic pressure regulator (sodium chloride), 0.5% stabilizer (hydroxypropyl-β-cyclodextrin, molecular weight 1541.54 Da), 1.5% pH adjuster (boric acid and borax in a mass ratio of 2:1), and the remainder is deionized water.

[0039] Blueberry extract, moisturizer, taurine, stabilizer and deionized water are mixed evenly, then osmotic pressure regulator and pH regulator are added and mixed evenly, and finally human type III collagen is added and mixed evenly to obtain a protein-containing moisturizing eye drop.

[0040] Example 3

[0041] The protein-containing moisturizing eye drops are prepared from the following components by mass fraction: 0.22% human type III collagen, 0.1% chamomile extract, 0.2% moisturizer (hyaluronic acid, molecular weight 180~200kDa), 0.1% taurine, 0.8% osmotic pressure regulator (potassium chloride), 1% stabilizer (hydroxypropyl methylcellulose K100M), 0.7% pH adjuster (boric acid and borax in a mass ratio of 4:3), and the remainder is deionized water.

[0042] Blueberry extract, moisturizer, taurine, stabilizer and deionized water are mixed evenly, then osmotic pressure regulator and pH regulator are added and mixed evenly, and finally human type III collagen is added and mixed evenly to obtain a protein-containing moisturizing eye drop.

[0043] Comparative Example 1

[0044] The blueberry extract and sodium hyaluronate of Example 1 are omitted, and the human type III collagen content is 0.5%. Other process conditions are the same as in Example 1.

[0045] Comparative Example 2

[0046] The human type III collagen and hydroxypropyl methylcellulose K100M from Example 1 are omitted, and the other process conditions are the same as in Example 1.

[0047] Comparative Example 3

[0048] The chamomile extract and taurine in Example 3 are omitted, and the other process conditions are the same as in Example 3.

[0049] The performance of the eye drops from Examples 1-3 and Comparative Examples 1-3 was tested.

[0050] (1) Eye irritation test: New Zealand rabbits were randomly divided into 6 groups of 10 rabbits each. There were no significant differences in age and weight among the groups. The eye drops prepared in Examples 1-3 and Comparative Examples 1-3 were used for the test. 0.05 mL of the eye drop was instilled into the left eye of each rabbit in each group, while the right eye served as a blank control and was instilled with an equal amount of water for injection. The eyes of the rabbits were closed for 10 seconds after the eye drops were instilled, twice a day for 21 consecutive days. The irritation of the left eye of the rabbits by different eye drops was tested using the Draize eye irritation test. The results showed that after 21 days, the left eyes of rabbits instilled with the eye drops of Examples 1-3 showed no obvious discharge, no congestion, and no irritation; the left eyes of rabbits instilled with the eye drops of Comparative Example 2 showed obvious discharge, congestion, and mild irritation after 21 days; and the left eyes of rabbits instilled with the eye drops of Comparative Examples 1 and 3 showed obvious discharge, congestion, and mild irritation after 14 days.

[0051] (2) Comfort test: Sixty volunteers who wear contact lenses long-term were tested: 10 volunteers in each group wore the same type of contact lenses and had no eye diseases. They wore the contact lenses for 12 hours after instilling 1 drop of lubricating eye drops every day for 3 months. Volunteers who instilled lubricating eye drops from Examples 1-3 did not experience dry eyes, eye discomfort, or foreign body sensation after wearing contact lenses for 12 hours every day; volunteers who instilled lubricating eye drops from Comparative Examples 1-3 began to experience dry eyes and foreign body sensation after wearing contact lenses for 8 hours every day.

[0052] (3) Moisturizing performance test: 60 volunteers with normal vision who did not need to wear glasses were tested: 10 volunteers in each group instilled 1 drop of eye drops daily and then read continuously in the same routine environment. When they felt discomfort such as dry eyes or blurred vision, they instilled the eye drops again. The instillation time intervals for the eye drops in the examples and comparative examples were recorded. The results showed that the instillation time interval for the eye drops in Examples 1-3 was 4-5 hours, while the instillation time interval for the eye drops in Comparative Examples 1-3 was less than 2.5 hours.

[0053] As can be seen from the examples and comparative examples, the human-derived type III collagen, plant extracts, taurine, and moisturizer of the present invention work synergistically to provide excellent moisturizing effects without irritation or discomfort, and have a long-lasting moisturizing effect. Arbitrarily changing the components and dosage of the eye drops of the present invention will lead to a decrease in the performance of the eye drops. The eye drops of Examples 1-3 of the present invention have an osmotic pressure of 280-300 mOsmol / kg and a pH value of 6.5-7.5, which can regulate the body's balance function, enhance eye cell vitality, and improve eye microcirculation; they also have a long-lasting moisturizing effect and relieve eye fatigue.

[0054] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A protein-containing moisturizing eye drop, characterized in that, The moisturizing eye drops contain the following components by weight: 0.05-0.3% human type III collagen, 0.05-0.3% plant extracts, 0.1-0.5% humectant, 0.05-0.12% taurine, 0.5-1.5% osmotic pressure regulator, 0.3-1% stabilizer, 0.5-1.5% pH adjuster, and the remainder is water.

2. The protein-containing moisturizing eye drop according to claim 1, characterized in that, The molecular weight of the human type III collagen is 20-30 kDa.

3. The protein-containing moisturizing eye drop according to claim 1 or 2, characterized in that, The plant extract is blueberry extract and / or chamomile extract.

4. The protein-containing moisturizing eye drop according to claim 3, characterized in that, Blueberry extract was obtained by enzymatic hydrolysis with a complex glycosidase, which was a mixture of β-D-glucosidase and α-L-arabinosidase in a mass ratio of 1 to 3:

1.

5. The protein-containing moisturizing eye drop according to claim 4, characterized in that, The enzymatic hydrolysis temperature is 35~45℃, and the enzymatic hydrolysis time is 6~8h.

6. The protein-containing moisturizing eye drop according to claim 3, characterized in that, The moisturizer is one or more of hydroxypropyl methylcellulose, hyaluronic acid, and sodium hyaluronate.

7. The protein-containing moisturizing eye drop according to claim 6, characterized in that, The osmotic pressure regulator is sodium chloride and / or potassium chloride.

8. The protein-containing moisturizing eye drop according to claim 6 or 7, characterized in that, The stabilizer is hydroxypropyl-β-cyclodextrin and / or hydroxypropyl methylcellulose.

9. The protein-containing moisturizing eye drop according to claim 8, characterized in that, The pH adjuster is boric acid and borax, with a mass ratio of boric acid to borax of 2~4:1~3.

10. A method for preparing the protein-containing moisturizing eye drop according to any one of claims 1 to 9, characterized in that, The process includes the following steps: mixing plant extracts, moisturizers, taurine, stabilizers, and water; then adding osmotic pressure regulators and pH regulators and mixing again; finally, adding human type III collagen and mixing again to obtain a protein-containing moisturizing eye drop.