Contact lens care solution with long-acting moisturizing and antibacterial effects and preparation method thereof

Abstract

The invention discloses a contact lens care solution with long-acting moisturizing and antibacterial effects and a preparation method of the contact lens care solution, the care solution comprises the following components in percentage by mass: 0.05-1.5% of lysozyme; 0.01 to 0.5 percent of glycine betaine; 0.1-3% of a thickening agent; 0.05 to 4% of a surfactant; 0.2-5% of a pH regulator; 0.4-6% of an osmotic pressure regulator; and the balance of purified water. The preparation method comprises the following steps: adding part of purified water and lysozyme into a container, supplementing part of purified water, and stirring for dissolving; adding betaine, a thickening agent and a surfactant, supplementing part of purified water, uniformly stirring and mixing, adjusting the pH value to 6.5-7.8 and the osmotic pressure to 260-340 mOsm / kg.H2O, finally adding the balance of purified water, and uniformly stirring; and filtering and sub-packaging to obtain the product. The lysozyme and the betaine are added into the care solution at the same time, the synergistic effect of the lysozyme and the betaine has the effects of efficient moisturizing and lasting sterilization and disinfection, glasses can be effectively kept moist, and pollution of gram-positive bacteria such as staphylococcus aureus and escherichia coli can be resisted, so that eye inflammation and infection are relieved, and the effect of protecting eyes is achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of contact lens care, and in particular relates to a contact lens care solution with long-lasting moisturizing and antibacterial effects and a preparation method thereof. Background Art

[0002] Contact lenses are prone to deposits on the surface of the lenses during long-term wear, including proteins, lipids, and pathogenic microorganisms, which not only reduce the light transmittance and comfort of the lenses, but also cause varying degrees of pathological changes in the wearer's eyes. Therefore, contact lens care solutions are needed for cleaning and disinfection. With the widespread use of contact lenses, the application of contact lens care solutions is becoming more and more common. However, most bactericides in traditional contact lens care solutions use biguanide bactericides, such as polyhexamethylene biguanide hydrochloride, polyaminopropyl biguanide, etc., which cause great damage to the human body when the concentration in the eyes is too high due to long-term use, especially for people with sensitive corneas, which will cause varying degrees of pathological problems in the wearer's eyes. In addition, after long-term use of existing contact lens care solutions, the moisturizing effect is reduced, affecting the comfort of the wearer. Summary of the invention

[0003] Based on the above, the purpose of the present invention is to provide a contact lens care solution with long-lasting moisturizing and antibacterial effects, so as to solve the technical problems that the existing contact lens care solutions do not have long-lasting moisturizing effects and may cause damage to the human body after long-term use.

[0004] Another object of the present invention is to provide a method for preparing the contact lens care solution.

[0005] To achieve its purpose, the present invention adopts the following technical solution: A contact lens care solution with long-term moisturizing and antibacterial effects, comprising the following components by mass percentage: Lysozyme: 0.05-1.5%; Betaine: 0.01-0.5%; Thickener: 0.1-3.0%; Surfactant: 0.05-4.0%; pH adjuster: 0.2-5.0%; Osmotic pressure regulator: 0.4-6.0%; The balance is purified water.

[0006] As a further preferred embodiment of the technical solution of the present invention, the thickener is a mixture of one or more of sodium hyaluronate, hydroxypropyl methylcellulose or methyl glucose derivatives.

[0007] Furthermore, the surfactant is any one of poloxamer 407, glyceride or polysorbate.

[0008] Furthermore, the osmotic pressure regulator is one or a mixture of more than one of sodium chloride, potassium chloride or calcium chloride.

[0009] Furthermore, the pH adjuster is one or a mixture of dipotassium hydrogen phosphate, potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, boric acid or borax.

[0010] The preparation method of the contact lens care solution having long-term moisturizing and antibacterial effects comprises the following steps: (1) Weigh each component according to the formula and set aside; (2) Add some purified water into the container, then add lysozyme, then add some purified water, and stir to dissolve; (3) Add betaine, thickener and surfactant, add some purified water and stir to mix evenly. Add pH regulator and osmotic pressure regulator to adjust pH to 6.5-7.8 and osmotic pressure to 260-340 mOsm / kg·H2O, and finally add the remaining amount of purified water and stir for 2-3 hours; (4) Filtering the solution prepared in step (3), taking the filtrate and packaging it to obtain the contact lens care solution.

[0011] Furthermore, in step (2), the stirring time is 30-40 minutes.

[0012] Furthermore, in step (3), the stirring and mixing time is 1-2 hours.

[0013] Furthermore, in step (4), the solution prepared in step (3) is filtered using a 0.22 μm filter membrane.

[0014] Furthermore, in step (4), the solution prepared in step (3) is filtered twice using a 0.22 μm filter membrane.

[0015] By adopting the above technical solution, the present invention achieves the following beneficial effects: As a natural bactericide and preservative, lysozyme is non-toxic to the human body and has no side effects. It can completely replace traditional bactericides such as polyhexamethylene biguanide hydrochloride.

[0016] Betaine is a methylated amino acid that can provide active methyl groups to the body and regulate osmotic pressure. As a natural amino acid moisturizer, betaine can not only quickly improve water retention capacity due to its unique moisturizing properties and protective properties for cell membranes, but also increase the solubility of active ingredients in water, reduce the irritation of surfactants to the body, and can maintain long-lasting moisturizing even at low concentrations. In addition, betaine also has a cleaning effect and has a significant antibacterial effect on Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans. At the same time, betaine has a stabilizing effect on lysozyme and can be used as an additive to promote the refolding of denatured reduced lysozyme. In addition, betaine not only has effective hygroscopic and moisturizing properties, and does not absorb water from the body, but also, as a widely existing permeabilizer in nature, has a certain stabilizing effect on protein structure. Therefore, in the presence of betaine, the activity of lysozyme is well protected and the bactericidal effect is better.

[0017] In summary, the synergistic effect of adding lysozyme and betaine to contact lens care solution has the effects of efficient moisturizing, long-lasting bactericidal and disinfecting. It can effectively keep the lenses moist, fight against contamination by Gram-positive bacteria such as Staphylococcus aureus and Escherichia coli, thereby reducing eye inflammation and infection and protecting the eyes. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 The observation results of Escherichia coli in the antimicrobial effect test; Figure 2 The results of the antibacterial effect test on Staphylococcus aureus were observed; Figure 3 The figure is a comparison chart of the sterilization rates of the antibacterial care solutions in Example 5 and Comparative Example 1. DETAILED DESCRIPTION

[0019] The composition and performance of the care solution of the present invention are described in detail below through specific examples.

[0020] In the following examples of the present invention, the lysozyme was purchased from Sigma-Aldrich (Shanghai) Trading Co., Ltd., product number L4919.

[0021] Example 1 A contact lens care solution with long-term moisturizing and antibacterial effects: the solution comprises, by mass percentage, 0.1% lysozyme, 0.2% betaine, 0.5% sodium hyaluronate, 0.5% poloxamer 407, 1.2% boric acid, 0.4% borax, 0.9% sodium chloride, and the balance is purified water.

[0022] Example 2 A contact lens care solution with long-term moisturizing and antibacterial effects: the solution comprises, by mass percentage, 0.2% lysozyme, 0.3% betaine, 0.5% poloxamer 407, 0.2% hydroxypropyl methylcellulose, 1.2% boric acid, 0.4% borax, 0.8% sodium chloride, and the balance is purified water.

[0023] Example 3 A contact lens care solution with long-term moisturizing and antibacterial effects: the solution comprises, by mass percentage, 0.2% lysozyme, 0.1% betaine, 0.5% poloxamer 407, 0.2% hydroxypropyl methylcellulose, 1.2% boric acid, 0.4% borax, 0.9% sodium chloride, and the balance is purified water.

[0024] Example 4 A contact lens care solution with long-term moisturizing and antibacterial effects: the solution comprises, by mass percentage, 0.1% lysozyme, 0.3% betaine, 0.5% poloxamer 407, 0.2% hydroxypropyl methylcellulose, 1.2% boric acid, 0.4% borax, 0.8% sodium chloride, and the balance is purified water.

[0025] Example 5 A contact lens care solution with long-term moisturizing and antibacterial effects: the solution comprises, by mass percentage, 0.2% lysozyme, 0.3% betaine, 0.5% poloxamer 407, 0.2% sodium hyaluronate, 1.2% boric acid, 0.4% borax, 0.8% sodium chloride, and the balance is purified water.

[0026] Comparative Example 1 The other ingredients and contents of Comparative Example 1 are the same as those of Example 5, except that the antibacterial agent lysozyme is not added in Comparative Example 1.

[0027] Comparative Example 2 The other ingredients and contents of Comparative Example 2 and Example 3 are the same, except that the humectant betaine is not added in Comparative Example 2.

[0028] The performance parameters of the contact lens care solutions in the above embodiments and comparative examples are shown in Table 1.

[0029] The following tests were conducted on the moisturizing and lubricating effect, antibacterial effect and disinfecting effect of the contact lens care solution.

[0030] 1. Moisturizing and lubricating effect test Experiment 1: Evaluation of eye irritation and comfort of the care solution 50 people were randomly selected and evenly divided into 5 groups. The care solutions in Examples 1-5 were first dropped into the eyes for an eye irritation test, and then the contact lenses were immersed in them for 4 hours for a lens comfort test. At the same time, the care solutions were compared with those in Comparative Example 2, and the data were recorded. The above experimental data are shown in Table 2.

[0031] Experiment 2: Lens water loss rate test The contact lenses were immersed in the care solutions of Examples 1-5 and Comparative Example 2, respectively. 20 lenses were immersed in each group of care solutions for 24 hours. The water loss time of the water film was then tested with a halogen rapid moisture meter and the test results were recorded. The above experimental results are shown in Table 3.

[0032] Where: T: time of lens water loss; M1: weight of lens before water loss; M2: weight of lens after water loss; M 失 : Water loss of the lens; WL: Water loss rate of the lens (the amount of water lost by the lens per second).

[0033] The experimental results show that compared with the comparative example 2, the water loss of the care solutions in Examples 1-5 is significantly slowed down, and the lens drying time is significantly delayed, which shows that the care solutions prepared by the present invention have a good moisturizing effect and can greatly improve the wearing comfort of contact lenses.

[0034] (II) Antibacterial effect test After the contact lenses were soaked in the care solutions of Examples 3-4 and Comparative Example 1 for 6 hours, a microbial experiment was conducted to observe the antibacterial zone of the lenses. The specific operation was as follows: qualified lenses were soaked in the care solutions obtained in Examples 3, 4 and Comparative Example 1 for 6 hours, and then spread on the plates evenly coated with Escherichia coli and Staphylococcus aureus, and a drop of the care solution samples obtained in Examples 3, 4 and Comparative Example 1 was transferred to the corresponding lenses using a 100 uL range pipette. The plates were placed in a sterile incubator at 37°C for 24 hours. The observation results of Escherichia coli were shown in Table 1. Figure 1 The observation results of Staphylococcus aureus are shown in Figure 2 .

[0035] Figure 1-2 The results show that the antibacterial zone of the lens soaked in the care solution in Example 3-4 is large, and the antibacterial zone of the lens soaked in the care solution in Comparative Example 1 is small, indicating that the care solution in Example 3-4 has a strong antibacterial effect on Escherichia coli and Staphylococcus aureus.

[0036] 3. Disinfection effect test Citing "Ophthalmic Optical Contact Lens Care Products Part 3: Microbiological Requirements and Experimental Methods and Contact Lens Care Systems" (YY0719.3-2009), combined with GB19192-2003 "Hygiene Requirements for Contact Lens Care Solutions", the antibacterial care solutions produced in Example 5 and Comparative Example 1 were subjected to disinfection effect verification tests. The specific operation was as follows: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Fusarium solani in the slant culture medium were diluted with 0.1 M phosphate (PBS) buffer (pH 7.2) to a bacterial content of 1.4×10 7 cfu / mL, 1.2×10 7 cfu / mL, 1.2×10 7 cfu / mL, 1.2×10 6 cfu / mL, 1.1×10 6 cfu / mL of bacterial suspension, and then 100 uL of bacterial suspension was taken in PBS buffer to obtain 5 kinds of bacterial suspensions (the bacterial amount was 1.4×10 6 cfu / mL, 1.2×10 6 cfu / mL, 1.2×10 6 cfu / mL, 1.2×10 5 cfu / mL, 1.1×10 5 cfu / mL). Take 5 portions of 10 mL of the care solution obtained in Example 5 and the care solution obtained in Comparative Example 1, and add them to the above five bacterial suspensions respectively. The care solution in Example 5 and the care solution in Comparative Example 1 act on Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Fusarium solani for 1.5-24 h, respectively. After coating, incubate in an incubator for 48-72 h. Fusarium solani is incubated at 20-25°C for 10-14 days, and the colonies are counted. Record the experimental data. The bactericidal effect data of the care solution are shown in Table 4, and the bactericidal rate bar graph is shown in Figure 3 .

[0037] The results in Table 4 show that (1) Bactericidal effect on bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli): In Example 5, within the shortest recommended immersion time, the average reduction in the number of recovered growth bacteria per milliliter for each test bacteria was greater than 99.9% (3.0 logs); (2) Bactericidal effect on yeast and mold (Candida albicans, Fusarium solani of the Solanaceae family): In Example 5 and Comparative Example 1, within the shortest recommended immersion time, the average reduction in the number of recovered growth bacteria per milliliter for each test bacteria was greater than 90% (1.0 logs), and the bacterial count did not increase within a immersion time that was not less than four times the shortest recommended time, and the test error was within ±0.5 logs.

[0038] Figure 3The results show that the sterilization rates of the care solution in Example 5 against bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli), molds and yeasts (Candida albicans, Fusarium solani) are all higher than those in Comparative Example 1.

[0039] Therefore, adding lysozyme and betaine to contact lens care solution at the same time has a synergistic effect of highly efficient moisturizing, long-lasting bactericidal and disinfecting effects. It can effectively keep the lenses moist and fight against contamination by Gram-positive bacteria such as Staphylococcus aureus and Escherichia coli, thereby reducing eye inflammation and infection and protecting the eyes.

Claims

1. A contact lens care solution with long-term moisturizing and antibacterial effects, characterized in that: In terms of mass percentage, the care solution includes the following components: Lysozyme: 0.05-1.5%; Betaine: 0.01-0.5%; Thickener: 0.1-3.0%; Surfactant: 0.05-4.0%; pH adjuster: 0.2-5.0%; Osmotic pressure regulator: 0.4-6.0%; The balance is purified water.

2. A contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 1, characterized in that: The thickener is one or a mixture of more than one of sodium hyaluronate, hydroxypropyl methylcellulose or methyl glucose derivatives.

3. A contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 2, characterized in that: The surfactant is any one of poloxamer 407, glyceride or polysorbate.

4. A contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 1, characterized in that: The osmotic pressure regulator is one or a mixture of more than one of sodium chloride, potassium chloride or calcium chloride.

5. A contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 1, characterized in that: The pH regulator is one or a mixture of dipotassium hydrogen phosphate, potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, boric acid or borax.

6. A method for preparing a contact lens care solution with long-term moisturizing and antibacterial effects as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: (1) Weigh each component according to the formula and set aside; (2) Add some purified water into the container, then add lysozyme, then add some purified water, and stir to dissolve; (3) Add betaine, thickener and surfactant, add some purified water and stir to mix evenly. Add pH regulator and osmotic pressure regulator to adjust pH to 6.5-7.8 and osmotic pressure to 260-340 mOsm / kg·H2O, and finally add the remaining amount of purified water and stir for 2-3 hours; (4) Filtering the solution prepared in step (3), taking the filtrate and packaging it to obtain the contact lens care solution.

7. A method for preparing a contact lens care solution with long-term moisturizing and antibacterial effects as claimed in any one of claims 1 to 5, characterized in that: In step (2), the stirring time is 30-40 minutes.

8. The method for preparing a contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 7, characterized in that: In step (3), the stirring and mixing time is 1-2 hours.

9. The method for preparing a contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 8, characterized in that: In step (4), the solution prepared in step (3) is filtered using a 0.22 μm filter membrane.

10. The method for preparing a contact lens care solution with long-term moisturizing and antibacterial effects as claimed in claim 9, characterized in that: In step (4), the solution prepared in step (3) is filtered twice using a 0.22 μm filter membrane.

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