Contact lens preserving fluid and preparation method thereof
By combining components such as ectoine and schizopolysaccharide, the prepared contact lens preservation solution solves the problems of poor moisturizing and antibacterial effects in existing technologies, achieving long-lasting moisturizing, antibacterial and improved comfort, and reducing eye discomfort.
Patent Information
- Application Number
- CN202511812400.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-04
- Publication Date
- 2026-03-06
Abstract
Description
Technical Field
[0001] This invention relates to the field of contact lens technology, and more particularly to a contact lens preservation solution and its preparation method. Background Technology
[0002] Contact lenses are easily exposed to environments that come into contact with microorganisms during wear or storage, making them prone to becoming breeding grounds for microorganisms and easily contaminated. Soft contact lenses have high hydrophilicity and most carry a chemical charge, making them susceptible to the accumulation of proteins and lipids during use or storage. Insufficient moisturizing properties of contact lenses can lead to inadequate fluid filling between the cornea and the lens, while insufficient lubrication increases friction between the lens and the ocular surface. Prolonged wear of contact lenses can easily cause eye redness, dryness, congestion, trachoma, keratitis, and other eye diseases, seriously affecting people's normal lives.
[0003] The basic functions of contact lens preservation solutions are to clean, disinfect, and remove protein deposits from contact lenses, enhancing their moisturizing rate, antibacterial effect, and wearing comfort. Currently, commonly used contact lens preservation solutions with good moisturizing effects often contain hyaluronic acid and ectoine. Hyaluronic acid molecules contain a large number of carboxyl and hydroxyl groups, forming intramolecular and intermolecular hydrogen bonds in aqueous solutions, giving it a strong water-retention effect. However, it degrades rapidly in the body, resulting in a short retention time and failing to achieve long-term effectiveness. Ectoine has a unique highly polar molecular structure and strong water-retention and water-locking properties. The cyclic structure of ectoine molecules easily forms hydrogen bonds with water molecules, enhancing their association ability, and simultaneously forming a "hydration shell" around cells and proteins, similar to a stable protective film reducing water loss. Currently, contact lens preservation solutions containing ectoine cannot simultaneously achieve both moisturizing and antibacterial effects, and their moisturizing effect is relatively weak, providing only a temporary humidification effect and failing to maintain the wearer's comfort for an extended period.
[0004] Therefore, it is of great significance to provide a contact lens preservation solution containing ectoine that improves the comfort of wearing contact lenses and gives it long-lasting moisturizing and antibacterial properties. Summary of the Invention
[0005] The purpose of this invention is to provide a contact lens preservation solution and its preparation method to address the shortcomings of existing technologies.
[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a contact lens preservation solution comprising the following components in parts by weight: 1-5 parts ectoine, 0.3-4 parts schizopolysaccharide, 0.05-0.3 parts humectant, 0.3-1.2 parts pH adjuster, 0.5-1.5 parts osmotic pressure adjuster, 0.1-2 parts chelating agent, 0.1-3 parts surfactant, and 90-98 parts water.
[0007] Preferably, the molecular weight of the schizopolysaccharide is 50-150 kDa.
[0008] Preferably, the moisturizer is hydroxypropyl methylcellulose and / or collagen.
[0009] Preferably, the pH adjuster comprises boric acid and borax; the mass ratio of boric acid to borax is 2~5:1~3.
[0010] Preferably, the osmotic pressure regulator comprises one or more of sodium chloride, potassium chloride, and mannitol.
[0011] Preferably, the chelating agent comprises one or more of disodium ethylenediaminetetraacetate, citric acid, triethanolamine, and glycine.
[0012] Preferably, the surfactant comprises one or more of poloxamer, PEG-40 hydrogenated castor oil, polyethylene glycol, and decyl glucoside.
[0013] The present invention also provides a method for preparing the aforementioned contact lens preservation solution, comprising the following steps: 1) Mix the schizophyllum polysaccharide with water to obtain a schizophyllum polysaccharide solution; 2) Mix the schizopolysaccharide solution, ectoine, humectant, chelating agent, and surfactant to obtain a mixture; 3) Mix the mixture, pH adjuster and osmotic pressure adjuster to obtain the contact lens preservation solution.
[0014] Preferably, the mixing temperature in step 1) is 60~80℃ and the mixing time is 10~20min; the mixing temperature in steps 2) and 3) is independently 35~45℃ and the mixing time is independently 15~25min.
[0015] The beneficial effects of this invention are: 1) The combination of hydroxypropyl methylcellulose, collagen, and ectoine in this invention has good hydrophilicity, stability, and adhesion, allowing it to adhere to the surface of the contact object for a long time and retain moisture, thus improving the moisturizing effect of the contact lens preservation solution. Ectoine can keep the eyes moist, relieve dry eye symptoms caused by wearing contact lenses, and improve wearing comfort. Collagen can reduce abrasion between the contact lens and the cornea. The synergistic use of the two can keep the eyes moist and improve tear exchange, thus protecting the eyes. Hydroxypropyl methylcellulose can effectively absorb moisture and form a moisturizing layer on the surface of the eyeball, providing a long-lasting feeling of moisture. It can also increase the viscosity of the preservation solution, which helps to reduce friction on the lenses.
[0016] 2) Slit-fold polysaccharide has the effects of enhancing immunity, moisturizing, and antioxidation. It can easily penetrate into the cornea, thereby achieving the effects of eliminating inflammation and inhibiting bacteria, and preventing complications such as keratitis. Slit-fold polysaccharide and ectoine work together to have a synergistic effect, which can further improve the effects of moisturizing, anti-inflammatory, antibacterial and repair, and there is no need to add other functional ingredients, antibiotics, preservatives, etc. It can effectively kill bacteria and enhance eye resistance, and relieve eye fatigue.
[0017] 3) The preservation solution of the present invention can solve the problem of dry eyes, relieve eye fatigue, improve lubrication and moisturizing effect, eliminate inflammation, improve antibacterial ability, and improve the wearing comfort of contact lenses. Detailed Implementation
[0018] This invention provides a contact lens preservation solution comprising the following components in parts by weight: 1-5 parts ectoine, 0.3-4 parts schizopolysaccharide, 0.05-0.3 parts humectant, 0.3-1.2 parts pH adjuster, 0.5-1.5 parts osmotic pressure adjuster, 0.1-2 parts chelating agent, 0.1-3 parts surfactant, and 90-98 parts water.
[0019] The contact lens preservation solution of the present invention comprises 1-5 parts of ectoine, preferably 2-4 parts, more preferably 3 parts; 0.3-4 parts of schizopolysaccharide, preferably 0.7-3 parts, more preferably 1-2.5 parts, more preferably 1.5-2 parts; 0.05-0.3 parts of humectant, preferably 0.1-0.25 parts, more preferably 0.15-0.2 parts; and 0.3-1.2 parts of pH adjuster, preferably 0.5-1 parts, more preferably 0. 7-0.8 parts; 0.5-1.5 parts of osmotic pressure regulator, preferably 0.8-1.2 parts, more preferably 1 part; 0.1-2 parts of chelating agent, preferably 0.5-1.5 parts, more preferably 0.8-1.2 parts; 0.1-3 parts of surfactant, preferably 0.5-2.5 parts, more preferably 1-2 parts, more preferably 1.5-1.8 parts; 90-98 parts of water, preferably 92-96 parts, more preferably 94-95 parts.
[0020] In this invention, the molecular weight of the schizopolysaccharide is preferably 50-150 kD, more preferably 80-130 kD, and even more preferably 100-120 kD.
[0021] The slit polysaccharide of this invention can easily penetrate the cornea, further enhancing the multiple effects of the preservation solution, such as antifungal, anti-inflammatory, and promoting corneal epithelial repair. Moreover, due to its small molecular weight, the resulting contact lens preservation solution is highly water-soluble, non-toxic, has no side effects, and exhibits good anti-inflammatory properties.
[0022] In this invention, the moisturizer is preferably hydroxypropyl methylcellulose and / or collagen.
[0023] In this invention, hydroxypropyl methylcellulose is preferably hydroxypropyl methylcellulose K15M or K100M, collagen is preferably human type III collagen, and the molecular weight of collagen is preferably 20-40KD, more preferably 25-35KD, and even more preferably 30KD.
[0024] In this invention, the pH adjuster preferably comprises boric acid and borax; the mass ratio of boric acid to borax is preferably 2~5:1~3, more preferably 3~4:1.5~2.5, and even more preferably 3.5:2.
[0025] In this invention, boric acid and borax have good stability and can effectively resist changes in pH value, thereby improving the stability of the preservation solution.
[0026] In this invention, the osmotic pressure regulator preferably comprises one or more of sodium chloride, potassium chloride, and mannitol.
[0027] In this invention, sodium chloride, potassium chloride, and mannitol have good physiological compatibility and can adjust the osmotic pressure of the preservation solution to be close to the physiological osmotic pressure of the human body, thereby reducing stimulation or damage to cells.
[0028] In this invention, the chelating agent preferably comprises one or more of disodium ethylenediaminetetraacetate, citric acid, triethanolamine, and glycine.
[0029] In this invention, the surfactant preferably comprises one or more of poloxamer, PEG-40 hydrogenated castor oil, polyethylene glycol, and decyl glucoside; poloxamer is preferably poloxamer 188 or poloxamer 407.
[0030] In this invention, surfactants can enhance the ability of the preservation solution to remove protein deposits and lipid dirt on contact lenses, maintaining the cleanliness of the contact lenses; they can also increase the lubricity of contact lenses, reduce discomfort during wear, and improve comfort.
[0031] The present invention also provides a method for preparing the aforementioned contact lens preservation solution, comprising the following steps: 1) Mix the schizophyllum polysaccharide with water to obtain a schizophyllum polysaccharide solution; 2) Mix the schizopolysaccharide solution, ectoine, humectant, chelating agent, and surfactant to obtain a mixture; 3) Mix the mixture, pH adjuster and osmotic pressure adjuster to obtain the contact lens preservation solution.
[0032] In this invention, the mixing temperature in step 1) is preferably 60~80℃, more preferably 65~75℃, and even more preferably 70℃, and the mixing time is preferably 10~20min, more preferably 12~18min, and even more preferably 15~16min; the mixing temperatures in steps 2) and 3) are independently preferably 35~45℃, more preferably 37~43℃, and even more preferably 40℃, and the mixing times are independently preferably 15~25min, more preferably 17~23min, and even more preferably 20min.
[0033] 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.
[0034] In the examples and comparative examples, the molecular weight of the schizopolysaccharide was 100-120 kD, the hydroxypropyl methylcellulose was hydroxypropyl methylcellulose K100M, and the collagen was human type III collagen with a molecular weight of 30 kD. The stirring speed is 350 r / min.
[0035] Example 1
[0036] The contact lens preservation solution of this embodiment is made of the following components in parts by weight: 3 parts ectoine, 2.5 parts schizopolysaccharide, 0.2 parts humectant, 0.8 parts pH adjuster, 1 part osmotic pressure adjuster, 1.2 parts chelating agent, 1.8 parts surfactant, and 95 parts water; the humectant is collagen, the pH adjuster is boric acid and borax in a mass ratio of 3.5:2, the osmotic pressure adjuster is mannitol, the chelating agent is disodium ethylenediaminetetraacetate, and the surfactant is poloxamer 188.
[0037] The schizopolysaccharide and water were stirred and mixed at 70°C for 15 minutes to obtain a homogeneous schizopolysaccharide solution. The schizopolysaccharide solution, ectoine, humectant, chelating agent and surfactant were stirred and mixed at 40°C for 20 minutes to obtain a mixture. The mixture, pH adjuster and osmotic pressure adjuster were stirred and mixed at 40°C for 20 minutes to obtain a homogeneous contact lens preservation solution.
[0038] Example 2
[0039] The contact lens preservation solution of this embodiment is made of the following components in parts by weight: 2 parts ectoine, 1.5 parts schizopolysaccharide, 0.25 parts humectant, 0.5 parts pH adjuster, 1.2 parts osmotic pressure adjuster, 1.8 parts chelating agent, 0.5 parts surfactant, and 98 parts water; the humectant is hydroxypropyl methylcellulose, the pH adjuster is boric acid and borax in a mass ratio of 2:1, the osmotic pressure adjuster is sodium chloride, the chelating agent is citric acid, and the surfactant is polyethylene glycol 400.
[0040] Slit polysaccharide and water were stirred and mixed at 60°C for 20 minutes to obtain a homogeneous slit polysaccharide solution. The slit polysaccharide solution, ectoine, humectant, chelating agent and surfactant were stirred and mixed at 35°C for 25 minutes to obtain a mixture. The mixture, pH adjuster and osmotic pressure adjuster were stirred and mixed at 35°C for 25 minutes to obtain a homogeneous contact lens preservation solution.
[0041] Example 3
[0042] The contact lens preservation solution of this embodiment is made of the following components in parts by weight: 4 parts ectoine, 3.5 parts schizopolysaccharide, 0.1 parts humectant, 1 part pH adjuster, 0.6 parts osmotic pressure adjuster, 0.5 parts chelating agent, 2.5 parts surfactant, and 93 parts water; the humectant is collagen, the pH adjuster is boric acid and borax in a mass ratio of 4:1.5, the osmotic pressure adjuster is potassium chloride, the chelating agent is glycine, and the surfactant is decyl glucoside.
[0043] Slit polysaccharide and water were stirred and mixed at 80°C for 10 min to obtain a homogeneous slit polysaccharide solution. The slit polysaccharide solution, ectoine, humectant, chelating agent and surfactant were stirred and mixed at 45°C for 15 min to obtain a mixture. The mixture, pH adjuster and osmotic pressure adjuster were stirred and mixed at 45°C for 15 min to obtain a homogeneous contact lens preservation solution.
[0044] Comparative Example 1
[0045] The ingredients of schizopolysaccharide, collagen and disodium EDTA in Example 1 are omitted, and ectoine is replaced with 0.5 parts. Other process conditions are the same as in Example 1.
[0046] Comparative Example 2
[0047] Ectoin and poloxamer 188 were omitted in Example 1, and the molecular weight of the schizopolysaccharide was changed to 160kD. Other process conditions were the same as in Example 1.
[0048] The irritation, antibacterial properties, moisturizing properties, and comfort of the contact lens preservation solutions of Examples 1-3 and Comparative Examples 1-2 were tested.
[0049] (1) Irritation test of contact lens preservation solution: New Zealand rabbits were randomly divided into 5 groups of 8 rabbits each. There were no significant differences in age and weight among the groups. The preservation solutions prepared in Examples 1-3 and Comparative Examples 1-2 were used for the test. 0.05 mL of preservation solution was instilled into the left eye of each rabbit in each group, and the right eye served as a blank control, with an equal volume of water for injection instilled. The eyes of the rabbits were closed for 10 seconds after instillation of the test substance, twice a day for 28 consecutive days. The local eye reaction was observed and recorded after each administration. The eye irritation reaction scoring criteria were based on the eye irritation reaction judgment criteria in the "Guiding Principles for Preclinical Research of New Drugs (Western Medicines)," which were non-irritating, mildly irritating, moderately irritating, and strongly irritating. The results showed that rabbits treated with the preservation solutions of Examples 1-3 showed no irritation after 28 days, rabbits treated with the preservation solution of Comparative Example 1 showed mild irritation after 14 days, and rabbits treated with the preservation solution of Comparative Example 2 showed mild irritation after 28 days.
[0050] (2) Antibacterial test of the preservation solution: The preservation solutions of Examples 1-3 and Comparative Examples 1-2 were diluted 16 times with melted agar medium to prepare plate culture media. The plate culture media inoculated with the strains (the strains consisted of Staphylococcus aureus, Candida albicans, and Escherichia coli) were placed in an incubator at 37°C for 24 hours, and the growth of the strains on the culture media was observed. The results showed that no bacteria grew on the culture media prepared with the preservation solutions of Examples 1-3, while the culture media prepared with the preservation solutions of Comparative Examples 1-2 showed more obvious bacterial growth.
[0051] (3) Moisturizing and comfort test of the preservation solution: The test was conducted on 50 volunteers who wore contact lenses for a long time. The volunteers wore the same type of contact lenses, which were removed after being preserved in the preservation solution for 8 hours. They wore the lenses for 10 hours a day for 3 consecutive months. The contact lenses preserved in the preservation solutions of Examples 1 to 3 did not cause dry eyes, eye discomfort or foreign body sensation after 3 months of wear, and had excellent moisturizing performance and wearing comfort. The contact lenses preserved in the preservation solutions of Comparative Examples 1 to 2 began to cause dry eyes and foreign body sensation after 2 months of wear.
[0052] 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 contact lens storage solution, characterized by, The contact lens storage solution comprises components in the following mass fractions: 1-5 parts of ectoine, 0.3-4 parts of schizophyllan, 0.05-0.3 parts of humectant, 0.3-1.2 parts of pH regulator, 0.5-1.5 parts of osmotic pressure regulator, 0.1-2 parts of chelating agent, 0.1-3 parts of surfactant, and 90-98 parts of water.
2. The contact lens storage solution of claim 1, wherein The schizophyllan has a molecular weight of 50-150 kD.
3. The contact lens storage solution of claim 1 or 2, wherein, The humectant is hydroxypropyl methylcellulose and / or collagen.
4. The contact lens storage solution of claim 3, wherein, The pH regulator comprises boric acid and borax; the mass ratio of boric acid to borax is 2-5:1-3.
5. The contact lens storage solution of claim 3, wherein The osmotic pressure regulator comprises one or more of sodium chloride, potassium chloride, and mannitol.
6. The contact lens storage solution of claim 4 or 5, wherein, The chelating agent comprises one or more of disodium ethylenediaminetetraacetate, citric acid, triethanolamine, and glycine.
7. The contact lens storage solution of claim 6, wherein, The surfactant comprises one or more of poloxamer, PEG-40 hydrogenated castor oil, polyethylene glycol, and decyl glucoside.
8. The method of claim 1 to 7, wherein the contact lens storage solution is prepared by the steps of: The method comprises the following steps: 1) mixing schizophyllan and water to obtain a schizophyllan solution; 2) mixing the schizophyllan solution, ectoine, humectant, chelating agent, and surfactant to obtain a mixture; 3) mixing the mixture, pH regulator, and osmotic pressure regulator to obtain a contact lens storage solution.
9. The production method according to claim 8, characterized by, In step 1), the mixing temperature is 60-80°C, and the mixing time is 10-20 min; in steps 2) and 3), the mixing temperature is independently 35-45°C, and the mixing time is independently 15-25 min.