Novel silicone hydrogel contact lens and preparation method thereof

By optimizing the raw materials and manufacturing process of silicone hydrogel contact lenses, using fluorinated siloxane monomers and polyether-modified siloxane oligomers, combined with technologies such as ultrasonic treatment and supercritical CO2 extraction, the problems of lens turbidity, decreased oxygen permeability, and comfort of traditional silicone hydrogel contact lenses have been solved. This has improved the light transmittance and wearing comfort of the lenses, and reduced the production defect rate.

CN121574490APending Publication Date: 2026-02-27HUA NUOSEN (WUHAN) BIOMEDICAL TECH CO LTD
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Patent Information

Application Number
CN202511786747.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-01
Publication Date
2026-02-27

AI Technical Summary

Technical Problem

Traditional silicone hydrogel contact lenses are prone to problems such as lens clouding, decreased oxygen permeability, reduced comfort, and low production qualification rate during long-term wear. This is mainly due to the fact that the hydrophobic surface of the siloxane component easily adsorbs biomolecules, phase separation during polymerization, insufficient hydration stability of hydrophilic monomers, and poor mold release properties.

Method used

The preparation process is optimized to improve lens performance by using raw materials such as fluorinated siloxane monomers, polyether-modified siloxane oligomers, complex hydrophilic monomers, functional crosslinking agents, anti-deposition agents and natural moisturizing factors, combined with processes such as ultrasonic treatment, ultraviolet prepolymerization, supercritical CO2 extraction and plasma treatment.

Benefits of technology

It significantly improves the oxygen permeability, anti-deposition properties, wearing comfort, and production efficiency of the lenses, reduces protein adsorption, enhances the mechanical properties and light transmittance of the lenses, and reduces the risk of eye irritation.

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Abstract

The invention provides a novel silicone hydrogel contact lens and a preparation method thereof. The novel silicone hydrogel contact lens is prepared from the following raw materials in parts by weight: 5-30 parts of fluorine-containing siloxane monomer, 3-15 parts of polyether modified siloxane oligomer, 40-80 parts of composite hydrophilic monomer, a functional cross-linking agent, a photoinitiator, an anti-deposition agent and a natural moisturizing factor. The preparation method comprises the following steps: mixing and filtering the raw materials, performing ultraviolet prepolymerization and thermal polymerization, removing unreacted monomers through supercritical CO2 extraction, and performing post-treatment sterilization. Deposition resistance and oxygen permeability are improved through fluorine-containing siloxane, compatibility is optimized through polyether modified oligomer, wearing comfort is enhanced through an anti-deposition agent and a natural moisturizing factor, the oxygen permeability coefficient reaches 140-180 barrs, the protein adsorption quantity is reduced, the continuous wearing comfort is prolonged, and the contact lens is suitable for the field of high-performance contact lenses.
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Description

TECHNICAL FIELD

[0001] The present application relates to the field of contact lenses, in particular to a novel silicone hydrogel contact lens and a preparation method thereof. BACKGROUND

[0002] As an optical correction device for eyes, the wearing comfort, oxygen permeability and biocompatibility of contact lenses are the core performance indicators. Silicone hydrogel materials have become the mainstream development direction due to their high oxygen permeability and hydrophilicity. However, the existing technology still has the following key problems:

[0003] The hydrophobic surface of the siloxane component in traditional silicone hydrogel easily adsorbs biological macromolecules such as proteins and lipids in tears, which can cause lens turbidity, reduced oxygen permeability, and even eye inflammation after long-term wearing. The polarity difference between siloxane monomers and hydrophilic monomers is large, and phase separation easily occurs during polymerization, resulting in uneven mechanical properties and reduced light transmittance of the lens. The hydration stability of existing hydrophilic monomers is insufficient, and the lens surface can easily become dry and uncomfortable, especially after long-term wearing. Traditional solvent washing method cannot completely remove unreacted monomers, and residual components can cause eye irritation. Poor mold release property can easily cause lens edge damage, affecting product qualification rate. SUMMARY

[0004] The present application provides a novel silicone hydrogel contact lens and a preparation method thereof, which aims to improve the anti-deposition, oxygen permeability and wearing comfort of silicone hydrogel contact lenses by innovating the raw material system and optimizing the preparation process, to meet the long-term safe wearing needs.

[0005] The present application provides a novel silicone hydrogel contact lens, which comprises the following raw materials by weight: 30-50 parts of fluorine-containing siloxane monomer, 15-20 parts of polyether-modified siloxane oligomer, 20-30 parts of composite hydrophilic monomer, 0.1-0.5 parts of functional crosslinking agent, 0.3-1.0 parts of photoinitiator, 0.8-2.5 parts of anti-deposition agent, and 1.0-3.0 parts of natural moisturizing factor.

[0006] The fluorine-containing siloxane monomer is an acrylate derivative, which has the following structural characteristics: one end of the molecule is a trifluoromethyl group, which is connected to a C1-C3 alkylene group through 1-3 fluoromethylene groups; the alkylene group is connected to a silicon atom, and the silicon atom is bonded to a methyl or ethyl group, and a hydrogen atom or a C1-C2 alkyl-substituted oxygen group; the other end of the silicon atom is connected to an acrylate group through a C2-C4 alkylene group;

[0007] The polyether-modified siloxane oligomer has a number average molecular weight of 5,000-12,000, and its main chain is composed of two types of repeating units alternating between: one is a polydimethylsiloxane unit, and the other is a polyoxyethylene unit; wherein the total molecular weight of the polyoxyethylene unit is 500-1,800, and the molar ratio of polydimethylsiloxane unit to polyoxyethylene unit is 1:0.5-1.2.

[0008] The composite hydrophilic monomer is composed of hydroxyethyl methacrylate, N-vinylcaprolactam and acrylamide, with a weight ratio of 1-3:1:0.5-2.

[0009] The anti-deposition agent is a polyethylene glycol-poly(ε-caprolactone) block copolymer with a molecular weight of 2000-5000, and the natural moisturizing factor is a complex of ceramide and pyrrolidone carboxylic acid with a weight ratio of 1:2-5.

[0010] According to the present invention, a novel silicone hydrogel contact lens is provided, wherein the fluorinated siloxane monomer is selected from 3,3,3-trifluoropropylmethyldiethoxysilane acrylate or 2,2,2-trifluoroethylethyldimethoxysilane methacrylate.

[0011] According to the present invention, a novel silicone hydrogel contact lens is provided, wherein the functional crosslinking agent is a hydroxyl-containing dimethacrylate, specifically dimethylolpropane dimethacrylate or trimethylolethane dimethacrylate.

[0012] According to the present invention, a novel silicone hydrogel contact lens is provided, wherein the photoinitiator is 2-hydroxy-2-methyl-1-phenyl-1-propanone or 1-hydroxycyclohexylphenyl ketone, and its dispersion in the raw material system is optimized by ultrasonic treatment; the ultrasonic treatment power is 300-500W and the time is 5-10min.

[0013] A method for preparing the novel silicone hydrogel contact lens as described above is provided, comprising the following steps:

[0014] S1. Mix the fluorinated siloxane monomer, polyether-modified siloxane oligomer and composite hydrophilic monomer, stir in a 30°C constant temperature water bath for 30 min, add functional crosslinking agent, photoinitiator, anti-deposition agent and natural moisturizing factor, continue stirring until homogeneous, and then filter through a 0.22μm polytetrafluoroethylene filter membrane.

[0015] S2. Inject the filtrate into a breathable mold and prepolymerize under ultraviolet light for 15–25 min. The ultraviolet light wavelength is 365 nm, and the power is 10–20 mW / cm². 2 ;

[0016] S3. Remove unreacted monomers using supercritical CO2 extraction; pressure 8-12 MPa, temperature 40-50℃, time 30-45 min.

[0017] S4. Place the lenses in a borate buffer solution containing 0.05-0.2 wt% sodium hyaluronate for 24 hours to equilibrate, and then package them after sterilization at 120°C.

[0018] According to the present invention, a novel method for preparing silicone hydrogel contact lenses is provided, wherein the breathable mold in step S2 is made of poly4-methyl-1-pentene material, and the surface of the mold is subjected to plasma treatment to improve the release properties; the plasma treatment power is 100-200W and the time is 3-10s.

[0019] According to the method for preparing a novel silicone hydrogel contact lens provided by the present invention, the flow rate of supercritical CO2 extraction in step S3 is 1-2 L / min, and a step-wise pressure reduction is adopted during the extraction process, with a reduction of 2 MPa every 10 min.

[0020] This invention provides a novel silicone hydrogel contact lens and its preparation method. The trifluoromethyl and fluoromethylene structures of the fluorinated siloxane monomers reduce the surface energy of the lens, decreasing the physical adsorption of proteins and lipids. An anti-deposition agent further inhibits the deposition of biomolecules through steric hindrance. Experiments show that the amount of protein adsorption on the lens is reduced, and the wearing period is extended. The polyether-modified siloxane oligomer, through the alternating structure of polyoxyethylene and polydimethylsiloxane segments, forms a bridge between the siloxane and the hydrophilic monomer, effectively alleviating phase separation, improving lens transmittance and mechanical properties. The composite hydrophilic monomer, through the synergistic effect of multiple hydroxyl and amide groups, enhances hydration stability, maintaining a stable water content of 45%-75%. Natural moisturizing factors mimic tear film moisturizing components, reducing water evaporation; even after 16 hours of continuous wear, the surface remains moist, significantly reducing dryness. Fluorinated siloxane monomers have small fluorine atomic radii and high electronegativity, which can enhance the free volume of the molecular chain, resulting in an oxygen permeability coefficient of 140-180 barrers, which is higher than that of traditional silicone hydrogels. Supercritical CO2 extraction process thoroughly removes unreacted monomers, and combined with gamma-ray sterilization, it significantly reduces the risk of eye irritation. After plasma treatment, the surface polarity of poly4-methyl-1-pentene molds is improved, increasing the success rate of demolding. The two-step method of ultraviolet prepolymerization and thermal polymerization reduces internal stress, lowers the breakage rate of lens edges, and greatly improves production efficiency. Detailed Implementation

[0021] The embodiments described in this invention are only some, not all, of the embodiments of this invention. Generally, the components or methods described in the embodiments of this invention can be arranged and designed in various different configurations.

[0022] Therefore, the detailed description of the embodiments of the present invention provided below is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0025] This application provides a novel silicone hydrogel contact lens, comprising the following raw materials by weight: 30-50 parts of fluorinated siloxane monomer, 15-20 parts of polyether-modified siloxane oligomer, 20-30 parts of composite hydrophilic monomer, 0.1-0.5 parts of functional crosslinking agent, 0.3-1.0 parts of photoinitiator, 0.8-2.5 parts of anti-deposition agent, and 1.0-3.0 parts of natural moisturizing factor;

[0026] The fluorinated siloxane monomer is an acrylate derivative with the following structural features: one end of the molecule is a trifluoromethyl group, which is connected to a C1-C3 alkylene group through 1-3 fluoromethylene groups; the alkylene group is connected to a silicon atom, and the silicon atom is respectively bonded with a methyl or ethyl group, as well as a hydrogen atom or a C1-C2 alkyl-substituted oxygen group; the other end of the silicon atom is connected to an acrylate group through a C2-C4 alkylene group.

[0027] The polyether-modified siloxane oligomer has a number average molecular weight of 5,000-12,000, and its main chain is composed of two types of repeating units alternating between: one is a polydimethylsiloxane unit, and the other is a polyoxyethylene unit; wherein the total molecular weight of the polyoxyethylene unit is 500-1,800, and the molar ratio of polydimethylsiloxane unit to polyoxyethylene unit is 1:0.5-1.2.

[0028] The composite hydrophilic monomer is composed of hydroxyethyl methacrylate, N-vinylcaprolactam and acrylamide, with a weight ratio of 1-3:1:0.5-2.

[0029] The anti-deposition agent is a polyethylene glycol-poly(ε-caprolactone) block copolymer with a molecular weight of 2000-5000, and the natural moisturizing factor is a complex of ceramide and pyrrolidone carboxylic acid with a weight ratio of 1:2-5.

[0030] To further optimize the above technical solution, the fluorinated siloxane monomer is selected from 3,3,3-trifluoropropylmethyldiethoxysilane acrylate or 2,2,2-trifluoroethylethyldimethoxysilane methacrylate.

[0031] To further optimize the above technical solution, the functional crosslinking agent is a hydroxyl-containing dimethacrylate, specifically dimethylolpropane dimethacrylate or trimethylolethane dimethacrylate.

[0032] To further optimize the above technical solution, the photoinitiator is 2-hydroxy-2-methyl-1-phenyl-1-propanone or 1-hydroxycyclohexylphenyl ketone, and its dispersion in the raw material system is optimized by ultrasonic treatment; the ultrasonic treatment power is 300-500W and the time is 5-10min.

[0033] A method for preparing the novel silicone hydrogel contact lens as described above is provided, comprising the following steps:

[0034] S1. Mix the fluorinated siloxane monomer, polyether-modified siloxane oligomer and composite hydrophilic monomer, stir in a 30°C constant temperature water bath for 30 min, add functional crosslinking agent, photoinitiator, anti-deposition agent and natural moisturizing factor, continue stirring until homogeneous, and then filter through a 0.22μm polytetrafluoroethylene filter membrane.

[0035] S2. Inject the filtrate into a breathable mold and prepolymerize under ultraviolet light for 15–25 min. The ultraviolet light wavelength is 365 nm, and the power is 10–20 mW / cm². 2 ;

[0036] S3. Remove unreacted monomers using supercritical CO2 extraction; pressure 8-12 MPa, temperature 40-50℃, time 30-45 min.

[0037] S4. Place the lenses in a borate buffer solution containing 0.05-0.2 wt% sodium hyaluronate for 24 hours to equilibrate, and then package them after sterilization at 120°C.

[0038] To further optimize the above technical solution, the breathable mold in step S2 is made of poly4-methyl-1-pentene material, and the surface of the mold is treated with plasma to improve demolding properties; the plasma treatment power is 100-200W and the time is 3-10s.

[0039] To further optimize the above technical solution, the flow rate of supercritical CO2 extraction in step S3 is 1-2 L / min, and a step-wise pressure reduction is adopted during the extraction process, with a reduction of 2 MPa every 10 min.

[0040] To provide a clearer and more detailed description of the novel silicone hydrogel contact lens and its preparation method provided by the embodiments of the present invention, the following description will be based on specific embodiments.

[0041] Example 1

[0042] The preparation of a novel silicone hydrogel contact lens comprises the following raw materials by weight: 45 parts of fluorinated siloxane monomer 3,3,3-trifluoropropylmethyldiethoxysilane acrylate; 8 parts of polyether-modified siloxane oligomer with a number-average molecular weight of 8000, wherein the total molecular weight of polyoxyethylene units is 800, and the molar ratio of polydimethylsiloxane units to polyoxyethylene units is 1:0.8; and a composite hydrophilic monomer composed of hydroxyethyl methacrylate, N-vinylcaprolactam, and acrylamide in a weight ratio of 2:1:0.8. The dosages of the components were 10 parts, 5 parts, and 4 parts, respectively; the functional crosslinking agent was dimethylolpropane dimethacrylate, with a dosage of 0.3 parts; the photoinitiator was 2-hydroxy-2-methyl-1-phenyl-1-propanone, with a dosage of 0.6 parts, which was ultrasonically treated with 400W power for 8 minutes before use to optimize its dispersion in the raw material system; the anti-deposition agent was polyethylene glycol-poly(ε-caprolactone) block copolymer with a molecular weight of 3000, with a dosage of 1.5 parts; and the natural moisturizing factor was a complex composed of ceramide and pyrrolidone carboxylic acid in a weight ratio of 1:3, with a dosage of 2.0 parts.

[0043] The preparation process is as follows: First, the raw materials are mixed and pretreated. The above-mentioned fluorinated siloxane monomer, polyether modified siloxane oligomer, and hydroxyethyl methacrylate, N-vinylcaprolactam, and acrylamide in the composite hydrophilic monomer are added sequentially into a 500mL three-necked flask equipped with a stirring device. The flask is placed in a constant temperature water bath at 30℃, and stirring is started. The stirring speed is controlled at 300r / min and stirring is continued for 30 minutes to make the above raw materials initially mixed evenly. Subsequently, the functional crosslinking agent dimethylolpropane dimethacrylate, the photoinitiator 2-hydroxy-2-methyl-1-phenyl-1-propanone (treated with ultrasound), the anti-deposition agent polyethylene glycol-poly(ε-caprolactone) block copolymer, and the natural moisturizing factor were added to the mixture. The mixture was then stirred for 45 minutes at a water bath temperature of 30°C and a stirring rate of 300 r / min until a homogeneous and transparent solution was formed. At this point, the mixture was pressure filtered through a polytetrafluoroethylene (PTFE) filter membrane with a pore size of 0.22 μm to remove any possible small impurities and undissolved particles, resulting in a clear polymer solution.

[0044] Next, polymerization molding is performed using a breathable mold made of poly-4-methyl-1-pentene. Before use, the mold undergoes plasma treatment at a power of 150W for 4 seconds to improve its surface polarity and demolding performance. The filtered polymerization liquid is injected into the treated mold through a precision injection device, with the injection volume controlled at 95% of the mold cavity volume. The mold is then closed and sealed. The closed mold is transferred to an ultraviolet (UV) polymerization apparatus at a wavelength of 365nm and a power of 15mW / cm². 2 Prepolymerization is carried out under ultraviolet light for 20 minutes to allow the polymer solution to solidify and form.

[0045] After polymerization, unreacted monomers are removed using supercritical CO2 extraction. The mold containing the lens preform is placed in a supercritical extraction vessel, and CO2 gas is introduced after the vessel is closed to raise the pressure inside the vessel to 10 MPa. The temperature is controlled at 45°C, and the CO2 flow rate is adjusted to 1.5 L / min. Extraction is carried out under these conditions for 40 minutes. During the extraction process, a step-down pressure reduction method is used, reducing the pressure by 2 MPa every 10 minutes until the pressure inside the vessel drops to atmospheric pressure, so as to completely remove the unreacted monomers and small molecule impurities remaining in the lens.

[0046] Finally, the lenses undergo post-processing and packaging. The lenses, after supercritical fluid extraction, are removed from the mold and placed in a pre-prepared borate buffer solution containing 0.1 wt% sodium hyaluronate. They are equilibrated at room temperature for 24 hours to ensure complete hydration and adjust the pH to a physiologically suitable range (7.2-7.4). After equilibration, the lenses, along with the buffer solution, are placed into sterile packaging cups, sealed, and sterilized at 120°C with a sterilization dose of 30 kGy. Upon sterilization, the finished novel silicone hydrogel contact lenses are obtained.

[0047] Example 2

[0048] A novel silicone hydrogel contact lens is prepared using the following raw materials by weight: 40 parts of fluorinated siloxane monomer 2,2,2-trifluoroethyl ethyl dimethoxysilane methacrylate; 5 parts of polyether-modified siloxane oligomer with a number average molecular weight of 5000, wherein the total molecular weight of polyoxyethylene units is 500, and the molar ratio of polydimethylsiloxane units to polyoxyethylene units is 1:0.5; and 6 parts of a composite hydrophilic monomer consisting of hydroxyethyl methacrylate, 6 parts of N-vinylcaprolactam, and propylene. The product consists of 3 parts of amide in a weight ratio of 1:1:0.5; the functional crosslinking agent is trimethylolpropane dimethacrylate, with a dosage of 0.2 parts; the photoinitiator is 1-hydroxycyclohexylphenyl ketone, with a dosage of 0.4 parts, which is ultrasonically treated at 300W power for 10 minutes before use; the anti-deposition agent is polyethylene glycol-poly(ε-caprolactone) block copolymer with a molecular weight of 2000, with a dosage of 1.0 part; and the natural moisturizing factor is a complex of ceramide and pyrrolidone carboxylic acid in a weight ratio of 1:2, with a dosage of 1.5 parts.

[0049] In the preparation process, during the raw material mixing stage, the fluorinated siloxane monomer, polyether-modified siloxane oligomer, and composite hydrophilic monomer were first added to a three-necked flask and stirred at 300 rpm for 30 minutes in a 30°C water bath. Then, the remaining raw materials were added and stirring continued for 60 minutes until homogeneous. The mixture was then filtered through a 0.22 μm polytetrafluoroethylene membrane. For polymerization molding, a mold made of poly4-methyl-1-pentene was used. The surface of the mold was treated with 100W plasma for 6 seconds. After the polymerization liquid was injected, the mold was subjected to 365nm ultraviolet light (power 10mW / cm²).2 Polymerization was carried out for 25 minutes. Supercritical CO2 extraction conditions were: pressure 8 MPa, temperature 40 °C, flow rate 1 L / min, extraction time 30 minutes, using a step-wise pressure reduction. In the post-processing stage, the lenses were equilibrated in a borate buffer solution containing 0.05 wt% sodium hyaluronate for 24 hours, then sterilized at 120 °C before packaging.

[0050] Example 3

[0051] The preparation of a novel silicone hydrogel contact lens comprises the following raw materials by weight: 50 parts of fluorinated siloxane monomer 3,3,3-trifluoropropylmethyldiethoxysilane acrylate; 12 parts of polyether-modified siloxane oligomer with a number average molecular weight of 10,000, a total molecular weight of 1,000 in polyoxyethylene units, and a molar ratio of polydimethylsiloxane units to polyoxyethylene units of 1:1.2; 15 parts of a composite hydrophilic monomer consisting of hydroxyethyl methacrylate, 5 parts of N-vinylcaprolactam, and 10 parts of acrylamide in a weight ratio of 3:1:2; 0.5 parts of a functional crosslinking agent dimethylolpropane dimethacrylate; 0.9 parts of a photoinitiator 2-hydroxy-2-methyl-1-phenyl-1-propanone, which is ultrasonically treated at 500W for 5 minutes; 2.0 parts of an anti-deposition agent consisting of a polyethylene glycol-poly(ε-caprolactone) block copolymer with a molecular weight of 5,000; and 2.5 parts of a natural moisturizing factor consisting of a complex of ceramide and pyrrolidone carboxylic acid in a weight ratio of 1:5.

[0052] During preparation, the raw materials were mixed and stirred for 30 minutes before adding the remaining components. Stirring continued until homogeneous, followed by filtration. The mold was treated with 200W plasma for 5 seconds, and after the polymerization solution was injected, it was subjected to 365nm ultraviolet light (power 20mW / cm²). 2 Polymerization was carried out for 15 minutes. Supercritical CO2 extraction was performed at a pressure of 12 MPa, a temperature of 50°C, a flow rate of 2 L / min, and a time of 45 minutes, with a stepwise pressure reduction. After equilibration in a borate buffer solution containing 0.2 wt% sodium hyaluronate, the lenses were sterilized at 120°C and then packaged.

[0053] The performance of the novel silicone hydrogel contact lenses prepared in the above three embodiments was tested. The results showed that the oxygen permeability coefficient of Example 1 reached 165 barrers, the water content was 62%, and the protein adsorption capacity was only 8.2 μg / cm³. 2 The light transmittance is 96%, and there is no obvious dryness even after wearing it continuously for 16 hours. The mold release success rate is 98.5%. Example 2 has an oxygen permeability coefficient of 142 barrers, a water content of 48%, and a protein adsorption capacity of 9.5 μg / cm³. 2 It has a light transmittance of 95%, no dryness after 15 hours of continuous wear, and a demolding success rate of 98.2%; Example 3 has an oxygen permeability coefficient of 178 barrers, a water content of 70%, and a protein adsorption capacity of 7.8 μg / cm³. 2With a light transmittance of 97%, no dryness after 17 hours of continuous wear, and a 99.0% success rate in demolding. Compared with traditional silicone hydrogel contact lenses, the product prepared by this invention has significant improvements in oxygen permeability, anti-deposition properties, light transmittance, wearing comfort, and production stability, fully demonstrating the technical effect of synergistic innovation in raw material formulation and preparation process.

[0054] Therefore, this invention provides a novel silicone hydrogel contact lens and its preparation method. The trifluoromethyl and fluoromethylene structures of the fluorinated siloxane monomers can reduce the surface energy of the lens and decrease the physical adsorption of proteins and lipids. The anti-deposition agent further inhibits the deposition of biomolecules through steric hindrance. Experiments show that the amount of protein adsorption on the lens is reduced, and the wearing period is extended. The polyether-modified siloxane oligomer, through the alternating structure of polyoxyethylene segments and polydimethylsiloxane segments, forms a bridge between the siloxane and the hydrophilic monomer, effectively alleviating phase separation, improving lens transmittance, and enhancing mechanical properties. The composite hydrophilic monomer, through the synergistic effect of multiple hydroxyl groups and amide groups, improves hydration stability, and the water content can be stabilized at 45%-75%. The natural moisturizing factor mimics the moisturizing components of tears, reducing water evaporation, and the surface remains moist even after 16 hours of continuous wear, significantly reducing dryness. Fluorinated siloxane monomers have small fluorine atomic radii and high electronegativity, which can enhance the free volume of the molecular chain, resulting in an oxygen permeability coefficient of 140-180 barrers, which is higher than that of traditional silicone hydrogels. Supercritical CO2 extraction process thoroughly removes unreacted monomers, and combined with gamma-ray sterilization, it significantly reduces the risk of eye irritation. After plasma treatment, the surface polarity of poly4-methyl-1-pentene molds is improved, increasing the success rate of demolding. The two-step method of ultraviolet prepolymerization and thermal polymerization reduces internal stress, lowers the breakage rate of lens edges, and greatly improves production efficiency.

[0055] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A novel silicone hydrogel contact lens, characterized in that, The ingredients, by weight, include the following: 30-50 parts fluorinated siloxane monomer, 15-20 parts polyether-modified siloxane oligomer, 20-30 parts complex hydrophilic monomer, 0.1-0.5 parts functional crosslinking agent, 0.3-1.0 parts photoinitiator, 0.8-2.5 parts anti-deposition agent, and 1.0-3.0 parts natural moisturizing factor; The fluorinated siloxane monomer is an acrylate derivative and has the following structural characteristics: One end of the molecule is a trifluoromethyl group, which is connected to a C1-C3 alkylene group through 1-3 fluoromethylene groups; the alkylene group is connected to a silicon atom, and the silicon atom is respectively bonded with a methyl or ethyl group, as well as a hydrogen atom or a C1-C2 alkyl-substituted oxygen group; the other end of the silicon atom is connected to an acrylate group through a C2-C4 alkylene group. The polyether-modified siloxane oligomer has a number average molecular weight of 5,000-12,000, and its main chain is composed of two types of repeating units alternating between: one is a polydimethylsiloxane unit, and the other is a polyoxyethylene unit; wherein the total molecular weight of the polyoxyethylene unit is 500-1,800, and the molar ratio of polydimethylsiloxane unit to polyoxyethylene unit is 1:0.5-1.

2. The composite hydrophilic monomer is composed of hydroxyethyl methacrylate, N-vinylcaprolactam and acrylamide, with a weight ratio of 1-3:1:0.5-2. The anti-deposition agent is a polyethylene glycol-poly(ε-caprolactone) block copolymer with a molecular weight of 2000-5000, and the natural moisturizing factor is a complex of ceramide and pyrrolidone carboxylic acid with a weight ratio of 1:2-5.

2. The novel silicone hydrogel contact lens according to claim 1, characterized in that, The fluorinated siloxane monomer is selected from 3,3,3-trifluoropropylmethyldiethoxysilane acrylate or 2,2,2-trifluoroethylethyldimethoxysilane methacrylate.

3. The novel silicone hydrogel contact lens according to claim 1, characterized in that, The functional crosslinking agent is a hydroxyl-containing dimethacrylate, specifically dimethylolpropane dimethacrylate or trimethylolethane dimethacrylate.

4. The novel silicone hydrogel contact lens according to claim 1, characterized in that, The photoinitiator is 2-hydroxy-2-methyl-1-phenyl-1-propanone or 1-hydroxycyclohexylphenyl ketone, and its dispersion in the raw material system is optimized by ultrasonic treatment; the ultrasonic treatment power is 300-500W and the time is 5-10min.

5. A method for preparing a novel silicone hydrogel contact lens as described in claims 1-4, characterized in that, Includes the following steps: S1. Mix the fluorinated siloxane monomer, polyether-modified siloxane oligomer and composite hydrophilic monomer, stir in a 30°C constant temperature water bath for 30 min, add functional crosslinking agent, photoinitiator, anti-deposition agent and natural moisturizing factor, continue stirring until homogeneous, and then filter through a 0.22μm polytetrafluoroethylene filter membrane. S2. Inject the filtrate into a breathable mold and prepolymerize under ultraviolet light for 15–25 min. The ultraviolet light wavelength is 365 nm, and the power is 10–20 mW / cm². 2 ; S3. Remove unreacted monomers using supercritical CO2 extraction; pressure 8-12 MPa, temperature 40-50℃, time 30-45 min. S4. Place the lenses in a borate buffer solution containing 0.05-0.2 wt% sodium hyaluronate for 24 hours to equilibrate, and then package them after sterilization at 120°C.

6. The method for preparing a novel silicone hydrogel contact lens according to claim 5, characterized in that, The breathable mold described in step S2 is made of poly4-methyl-1-pentene material, and the surface of the mold is treated with plasma to improve demolding properties; the plasma treatment power is 100-200W and the time is 3-10s.

7. The method for preparing a novel silicone hydrogel contact lens according to claim 5, characterized in that, In step S3, the flow rate of supercritical CO2 extraction is 1-2 L / min, and a step-wise pressure reduction is adopted during the extraction process, with a decrease of 2 MPa every 10 min.