A contact lens care composition and method of making same

Abstract

The application relates to the technical field of contact lens care products, and particularly discloses a contact lens care composition containing agar oligosaccharide. The application also discloses the use of agar oligosaccharide as a component of the contact lens care composition. The contact lens care composition of the application can effectively reduce the occurrence of dry eye symptoms and reduce or relieve the discomfort caused by dry eye symptoms in addition to the cleaning and disinfection functions of the contact lens care product.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of contact lens care solution, more particularly, it relates to a contact lens care composition and a preparation method thereof. BACKGROUND

[0002] The definition of contact lens in GB / T11417 Ophthalmic optics contact lenses is "all ophthalmic lenses for wearing on the anterior surface of the eyeball". Different categories can be divided according to different attributes, such as corneal contact lenses and scleral contact lenses according to the size of the diameter, hard contact lenses and soft contact lenses according to the shape of the lens material, and single-focus contact lenses, bifocal contact lenses and multifocal contact lenses according to the optical design of the lens. Regardless of how it is divided and designed, its unchanging attribute is to cover the anterior surface of the eyeball, to varying degrees, contact with the cornea, sclera, conjunctiva and other eye tissues, and interact with tears to affect eye health.

[0003] Because the contact lens is worn into the eye, it is covered in front of the cornea, hindering the contact of the cornea with the air and causing corneal hypoxia. In addition, in addition to moistening the cornea and conjunctiva, the tear fluid also moistens the lens, causing a lack of tear fluid, causing the lens wearer to have eye dryness and acid swelling. A dedicated wetting solution is usually used to maintain moisture to meet the requirements of comfort and physiology. Moreover, with the development of society and technology, the channel for obtaining human information is more through electronic device reading, which brings the side effect that the contact time of the eye gradually increases, causing the eye to be in contact with the mobile phone screen, computer screen and projection device for a long time, causing the eye to have different degrees of dry eye symptoms. When dry eye occurs, the later stage basically relies on artificial tear products to relieve the discomfort caused. When inflammation is induced, the symptoms will be aggravated, and it may not be suitable to wear contact lenses.

[0004] Therefore, it is necessary to provide a contact lens care composition which can increase the moisturizing performance of the lens, effectively prevent or reduce the occurrence of dry eye, and effectively relieve the discomfort symptoms when dry eye occurs, and has a certain nourishing function for the eye. SUMMARY

[0005] In order to overcome the shortcomings of the prior art, the present application provides a contact lens care composition and a preparation method thereof. The contact lens care composition provided by the present application can improve the defects of poor moisturizing property and poor anti-inflammatory effect of the existing contact lens care solution.

[0006] To achieve the above technical purpose, the present application provides a contact lens care composition, which adopts the following technical scheme:

[0007] A contact lens care composition contains 0.01-1.0% mass percentage of agar oligosaccharide.

[0008] Preferably, further comprising 0.05-5.0% of vitamin B5 by mass percentage.

[0009] Preferably, further comprising one or more of bacteriostatic agent, surfactant, buffer, pH adjuster, osmotic pressure adjuster.

[0010] Further preferably, the contact lens care composition consists of the following components by mass percentage: oligo-gellan 0.01-1.0%, vitamin B5 0.01-1.0%, trehalose 0.05-5.0%, alkyl glycoside 0.01-0.05%, poloxamer 0.01-1.0%, sodium citrate 0.01-0.8%, polyaminopropyl biguanide 0.0001-0.2%, sodium chloride 0.1-0.9%, boric acid 0.1-0.8%, amino propanol 0.01-1.0%, water balance.

[0011] Preferably, the contact lens care composition consists of the following components by mass percentage: oligo-gellan 0.05-0.1%, vitamin B5 0.2-0.4%, trehalose 0.1-0.2%, alkyl glycoside 0.01-0.05%, poloxamer 0.01-1.0%, sodium citrate 0.01-0.8%, polyaminopropyl biguanide 0.0001-0.2%, sodium chloride 0.1-0.9%, boric acid 0.1-0.8%, amino propanol 0.01-1.0%, water balance.

[0012] Further preferably, the oligo-gellan is extracted from the seaweed of genus Gracilaria.

[0013] The application also provides a preparation method of the contact lens care composition, which adopts the following technical scheme:

[0014] A preparation method of a contact lens care composition, comprising the following steps:

[0015] S1, take a part of water, add oligo-gellan into the water, heat to dissolve and mix uniformly to obtain an oligo-gellan solution;

[0016] S2, take another part of water, add trehalose, vitamin B5, alkyl glycoside, poloxamer, sodium citrate, sodium chloride, boric acid, amino propanol, dissolve and mix uniformly, then add polyaminopropyl biguanide, stir uniformly, then add the oligo-gellan solution and mix uniformly, and add the remaining water;

[0017] S3, sterilize and filter the solution prepared in S2, and divide the filtrate.

[0018] The application also provides a use of the contact lens care composition in cleaning or disinfecting a contact lens.

[0019] The application also provides a use of oligo-gellan as a component of a contact lens care composition.

[0020] The application also provides a use of a combination of agar oligosaccharide and pro-vitamin B5 as an ingredient of a contact lens care composition

[0021] Agar is a polysaccharide component in the cell wall of marine red algae, which is usually extracted from Gelidium or Gracilaria algae. However, its high viscosity and poor solubility greatly limit its high-value application in medicine, health food and cosmetics. Agar oligosaccharide obtained by enzymatic or acid hydrolysis of agar has a reduced molecular weight, good water solubility and is easily absorbed by the human body, and its biological activity and application value are significantly improved. Agar oligosaccharide (AOS) is usually an oligosaccharide formed by 2-20 repeating units of agarobiose, which can be divided into two series of agar oligosaccharide (3, 6-endo-α-L-galactose residue) and neoagar oligosaccharide (β-D-galactose residue) according to the difference in the reducing end structure of the carbon chain. Its small molecular characteristics can quickly supplement the water in the contact lens, slowly release after wearing the lens to play a moisturizing role; its antioxidant properties can effectively prevent and / or reduce the probability of oxidative stress occurring in the eye; effectively relieve the swelling and pain symptoms in the eye, and synergistically with the nutritional effect of pro-vitamin B5, which is more conducive to eye health. The contact lens care composition containing agar oligosaccharide provided in the application can not only have the functions of cleaning and disinfection of conventional contact lens care compositions, but also can quickly supplement the water in the contact lens, improve the wearing comfort, effectively reduce the occurrence of dry eye symptoms, and reduce or relieve the discomfort caused by dry eye and inflammation.

[0022] The application has the following beneficial effects: compared with the prior art, the contact lens care composition containing agar oligosaccharide provided in the application has the moisturizing performance of polysaccharide and various biological activities of agar oligosaccharide, including antioxidant and anti-inflammatory activities. Its small molecular characteristics can quickly supplement the water in the contact lens, slowly release after wearing the lens to play a moisturizing role. Its antioxidant properties can effectively prevent and / or reduce the probability of oxidative stress occurring in the eye, effectively relieve the swelling and pain symptoms in the eye, and synergistically with the nutritional effect of pro-vitamin B5, which is more conducive to eye health. DETAILED DESCRIPTION

[0023] The application will be further described in detail below in combination with examples.

[0024] Example

[0025] Example 1

[0026] A contact lens care composition, the components and their corresponding mass percentages are shown in Table 1, and is prepared by the following steps:

[0027] S1, take one-third of purified water, add agar oligosaccharide to the purified water, heat to 90°C to dissolve and mix evenly, to obtain an agar oligosaccharide solution;

[0028] S2, take another one-third of purified water, add trehalose, vitamin B5, alkyl glycoside, poloxamer, sodium citrate, sodium chloride, boric acid, aminopropanol, dissolve and mix evenly at room temperature, then add polyaminopropyl biguanide, stir evenly, then add the agar oligosaccharide solution, and mix evenly, and add the remaining purified water;

[0029] S3, sterilize the solution prepared in S2, and filter the filtrate.

[0030] Examples 2-7

[0031] A contact lens care composition was prepared in the same way as Example 1, and the components and amounts are shown in Table 1.

[0032] Table 1 Components and mass percentages in Examples 1-7 (unit: %; total amount 100g)

[0033] Example 1 2 3 4 5 6 7 Gel oligosaccharides 0.1 0.01 1.0 0.1 0.1 0.1 0.1 Pantothenic acid precursor 0.1 0.01 1.0 0 0.1 0.1 0.1 Trehalose 0.5 0.05 5.0 0.5 0 0.5 0.5 Alkyl glycoside 0810 0.05 0.05 0.05 0.05 0.05 0 0.05 Poloxamer 127 0.2 0.2 0.2 0.2 0.2 0.2 0 Sodium citrate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Polyaminopropyl biguanide 0.0015 0.0015 0.0015 0.0015 0.0015 0.0015 0.0015 Sodium chloride 0.5 0.5 0.5 0.5 0.5 0.5 0.5 Boric acid 0.6 0.6 0.6 0.6 0.6 0.6 0.6 Aminopropanol 0.1 0.2 0.1 0.1 0.1 0.1 0.1 Purified water 97.7485 98.2785 91.4485 97.8485 98.2485 97.7985 97.9985

[0034] Comparative Examples

[0035] Comparative Example 1

[0036] A contact lens care composition was prepared in the same way as Example 1, and the difference from Example 1 is that Comparative Example 1 does not contain agar oligosaccharide, and the amount of vitamin B5 is increased to 0.2%.

[0037] Comparative Example 2

[0038] A contact lens care composition was prepared in the same way as Example 1, and the difference from Example 1 is that Comparative Example 1 does not contain agar oligosaccharide and vitamin B5, and the amount of purified water is increased to 97.9985%.

[0039] Performance test

[0040] I. Dry eye relief test

[0041] 1. Tear secretion test:

[0042] The contact lens care compositions prepared in Examples 1-7 and Comparative Examples 1-2 were used as test samples.

[0043] New Zealand white rabbits weighing 2-2.5 kg were used for the test. One drop of 1.0% atropine sulfate (AS) aqueous solution was added to both eyes of the animals, 3 times a day (9 am, 1 pm and 5 pm) for 5 days, to reduce tear production and induce dry eye. 10 milliliters of contact lens care composition was used to rinse the right eye 5 minutes after each AS administration.

[0044] Animals were subjected to the Schirmer I test at day 0 (before treatment) and at days 2, 3, 4, 5 after the beginning of the treatment. The tear secretion was measured once a day during the test, by placing a strip of absorbent paper in the lower conjunctival fornix of each eye of the rabbits before each administration of the solutions (AS and AG-Sol). The growth of the tear along the strip of absorbent paper was measured in millimeters. The values obtained for the eyes treated with atropine sulfate alone were compared with the values obtained for the eyes treated with the contact lens care compositions of the application.

[0045] The basal value of tear secretion was measured in a group of control animals, which were not subjected to the drug treatment.

[0046] The results of the tests are reported in Table 2 below.

[0047] Table 2 Results of the dry eye relief test (in mm) for Examples 1-7, Comparative Examples 1-2

[0048]

[0049] As can be seen from the results of the tests of Examples 1-3, the amount of tear secretion in the animals treated with the care compositions was not only not reduced, but was significantly increased, indicating that the contact lens care compositions prepared according to the application have a protective effect against the onset of dry eye. Example 1 is the best example.

[0050] A comparison of the results of Examples 1, 4 and Comparative Examples 1, 2 shows that the care compositions containing agar oligosaccharides significantly increase the amount of tear secretion in the eyes of the animals treated with them, while the care compositions containing pantothenic vitamin B5 increase the amount of tear secretion to a lesser extent. The care compositions containing both agar oligosaccharides and pantothenic vitamin B5 increase the amount of tear secretion to a much greater extent than the two components used alone, indicating that the combination of agar oligosaccharides and pantothenic vitamin B5 has a synergistic effect against dry eye.

[0051] 2. Corneal epithelial alteration test

[0052] The contact lens care composition prepared in Example 1 was used as the sample to be tested.

[0053] In the test for tear secretion, on days 3, 4 and 5 after the beginning of the treatment, the corneas were stained with 10 μL of a 1% w / w aqueous solution of fluorescein, and the degree of corneal epithelial alteration due to dry eye was evaluated by observing the corneas with a slit lamp equipped with a blue filter. In the presence of epithelial alterations, areas of the corneal surface were observed which were colored: fluopositive eyes.

[0054] The results of the tests are reported in Table 3.

[0055] Table 3 Slit lamp observation results

[0056]

[0057] As can be seen from the test results in Table 3, the percentage of fluorescence positive in the eyes not treated with the contact lens care composition of Example 1 increased with days, and exceeded 60% on the 4th day; while the percentage of fluorescence positive in the eyes treated with the care composition remained constant between the 4th day and the 5th day, and the percentage of fluorescence positive was greatly reduced, about 23%.

[0058] II. Lubrication and moisturization performance test

[0059] The contact lens care compositions prepared in Examples 1 and 5 were used as the sample to be tested.

[0060] 1. Lubrication performance test

[0061] A reciprocating moving micro-friction meter was used to study the friction coefficient of the lens: a glass disc coated with protein was installed on a rotating disc to simulate the surface of the eyelid.

[0062] Friction coefficient (CoF) = FF / FN

[0063] Where FF is the friction force between the lens surface and the friction disc surface, and FN is the normal load. The linear velocity covers the range of physiologically relevant eyelid velocity: 0.1 mm / s corresponds to the eyelid velocity when not fully blinking; 8 cm / s corresponds to the eyelid velocity when fully blinking.

[0064] Linear velocity of the friction disc v = r * RPM * 0.10472

[0065] Where v is the linear velocity, unit: m / s; r is the radius, unit: m; RPM is the angular velocity, unit: RPM (revolutions per minute); 0.10472 comes from the ratio of 2π / 60 RPM to rad / s.

[0066] The normal force applied on the lens is 2 mN.

[0067] The friction coefficient of the lens was tested at 0 min and 60 min, and the test results are shown in Table 2 below.

[0068] 2. Moisturization performance test:

[0069] The contact angle can be used to measure the moisturization performance of the care solution, the better the moisturization performance, the smaller the contact angle, and the more comfortable to wear.

[0070] Test Method: The contact angle of the contact solution with the lens was measured using the static drop method. The lens was immersed in the contact solution to be tested, and after 12 hours, the contact angle was measured using a surface tension meter. The contact solution was drawn up with a syringe, and a droplet was suspended at the needle tip and brought into contact with the lens. A photograph was taken immediately after contact, and the forward and backward contact angles were calculated from the images.

[0071]

[0072] Comparing the test results of Examples 1 and 5, it can be seen that after adding trehalose in Example 1, the coefficient of friction at 0 min and 60 min decreased significantly, indicating that the care composition containing trehalose can adhere to the contact lens surface and form a stable moisturizing and lubricating barrier layer of a certain thickness. At the same time, the contact angle of Example 1 also decreased significantly, indicating that trehalose, with its good biocompatibility, has high moisturizing properties.

[0073] In summary, the contact lens care composition containing agar oligosaccharides proposed in this application uses alkyl glycosides and poloxamer as cleaning agents and polyaminopropyl biguanide as a bactericide, giving it the basic and highly effective cleaning and disinfection functions of a care product; it uses agar oligosaccharides as an antioxidant and is combined with provitamin B5, which can effectively prevent and / or reduce the probability of dry eye caused by ocular oxidative stress and relieve symptoms of eye swelling and pain; it uses trehalose as a lubricant and moisturizer, which has good biocompatibility and lubricity, enhances comfort and lubrication, and can relieve eye dryness and other discomfort for a long time.

[0074] The contact lens care composition of this application, in addition to having the cleaning and disinfection functions of contact lens care products, can effectively reduce the occurrence of dry eye symptoms and reduce or alleviate the discomfort caused by dry eye syndrome.

[0075] The above description is merely a preferred embodiment of this application. The scope of protection of this application is not limited to the above embodiments. All technical solutions falling within the scope of this application's concept are within the scope of protection of this application. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of this application should also be considered within the scope of protection of this application.

Claims

1. A contact lens care composition characterized in that, 0.01-1.0% by mass of agar oligosaccharide and 0.05-5.0% by mass of vitamin B5.

2. The contact lens care composition of claim 1, wherein, It also contains one or more of bacteriostatic agent, surfactant, buffer, pH adjuster, osmotic pressure adjuster.

3. The contact lens care composition of claim 2, wherein, It is composed of the following components by mass percentage: agar oligosaccharide 0.01-1.0%, vitamin B5 0.01-1.0%, trehalose 0.05-5.0%, alkyl glycoside 0.01-0.05%, poloxamer 0.01-1.0%, sodium citrate 0.01-0.8%, polyaminopropyl biguanide 0.0001-0.2%, sodium chloride 0.1-0.9%, boric acid 0.1-0.8%, aminopropanol 0.01-1.0%, water balance.

4. The contact lens care composition of claim 3, wherein, It is composed of the following components by mass percentage: agar oligosaccharide 0.01-1.0%, vitamin B5 0.01-1.0%, trehalose 0.05-5.0%, alkyl glycoside 0.01-0.05%, poloxamer 0.01-1.0%, sodium citrate 0.01-0.8%, polyaminopropyl biguanide 0.0001-0.2%, sodium chloride 0.1-0.9%, boric acid 0.1-0.8%, aminopropanol 0.01-1.0%, water balance.

5. The contact lens care composition of claim 4, wherein, The agar oligosaccharide is extracted from Gracilaria seaweed.

6. A method of preparing a contact lens care composition according to any one of claims 3 to 5 characterised in that, It comprises the following steps: S1, take a part of water, add agar oligosaccharide into the water, heat and dissolve and mix evenly to obtain an agar oligosaccharide solution; S2, take another part of water, add trehalose, vitamin B5, alkyl glycoside, poloxamer, sodium citrate, sodium chloride, boric acid, aminopropanol, dissolve and mix evenly, then add polyaminopropyl biguanide, stir evenly, then add the agar oligosaccharide solution and mix evenly, and add the remaining water; S3, sterilize the solution prepared in S2, filter the filtrate and divide it into portions.

7. Use of the contact lens care composition according to any one of claims 1-5 for cleaning or disinfecting contact lenses.

8. Use of a combination of 0.01-1.0% by mass of agar oligosaccharide and 0.05-5.0% by mass of vitamin B5 as an ingredient of a contact lens care composition.

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