Silica hydrogel lens as well as preparation method and application thereof

Abstract

The invention provides a silicone hydrogel lens as well as a preparation method and application thereof, and belongs to the technical field of contact lenses. According to the invention, an organic silicon monomer is taken as a main body, a composite formula system of a high-oxygen-permeability silicon-based skeleton and a hydrophilic functional monomer is adopted, and a physical mixing process is adopted to realize dual-advantage fusion and accurate proportion of each core component, so that a product system with both oxygen permeability and comfort is obtained, and safe, comfortable and healthy vision correction choices are provided for consumers.

Description

Technical Field

[0001] This invention relates to the field of contact lens technology, and more particularly to a silicone hydrogel lens, its preparation method, and its application. Background Technology

[0002] Contact lenses, as a widely used vision correction tool, have evolved from rigid gas-permeable lenses to hydrogel lenses, and now to the mainstream silicone hydrogel lenses. The oxygen permeability of traditional hydrogel lenses depends on the water content of the material; according to Henry's Law, oxygen dissolved in the aqueous phase diffuses to the cornea. However, their oxygen permeability has a theoretical limit, often failing to meet the physiological oxygen demand of the cornea during prolonged periods of eye closure, potentially leading to corneal hypoxia and complications such as edema and neovascularization.

[0003] Silicone hydrogel materials have achieved a breakthrough in oxygen permeability by introducing organosiloxane components into the hydrogel polymer network. Due to their extremely low oxygen transport resistance, the siloxane segments can form highly efficient oxygen diffusion channels, increasing the oxygen permeability of the material several times compared to traditional hydrogels. This supports the physiological metabolic needs of the cornea and makes it possible to wear lenses for extended periods, even overnight.

[0004] However, despite the significant advantages of silicone hydrogels in oxygen permeability, a sharp contradiction remains between their inherent material properties and the physiological environment of the ocular surface, constituting a long-standing technical bottleneck in this field. This bottleneck is mainly reflected in the following three aspects: First, there is a contradiction between high oxygen permeability and surface wettability. To achieve high oxygen permeability, the material needs to contain a sufficient proportion of hydrophobic siloxane components. However, hydrophobic surfaces result in poor tear wettability, a large contact angle, accelerated tear film breakup, and lead to dryness and visual fluctuations. Simultaneously, hydrophobic surfaces are more prone to adsorbing biomolecules such as proteins and lipids from tears, forming deposits that affect visual clarity and may irritate the ocular surface. Existing technologies often employ surface modification treatments (such as plasma oxidation and hydrophilic polymer coatings) to improve hydrophilicity. For example, oxygen plasma treatment introduces hydrophilic groups such as hydroxyl and carboxyl groups onto the lens surface; or grafting polyvinylpyrrolidone coatings enhances surface wettability. However, these surface modification layers have durability issues; they may wear down or degrade under friction and eye discharge during wear, causing hydrophilicity to decline over time and failing to guarantee long-term comfort.

[0005] Second, there is a conflict between material modulus and wearing comfort. High siloxane content and the cross-linking density required to maintain lens shape often result in a high elastic modulus (typically >0.8 MPa) for silicone hydrogel lenses. A higher modulus means greater lens rigidity, potentially increasing mechanical irritation to the cornea and eyelids, leading to a foreign body sensation, especially for patients with sensitive eyes. Simultaneously, high-modulus lenses have poor dynamic adaptability to corneal curvature. Although some technologies have attempted to reduce modulus by introducing long-chain flexible siloxane monomers (such as TRIS-VC) or using lactone monomers, these often result in reduced material strength, poorer processing performance, or impaired oxygen permeability, making it difficult to achieve an ideal balance between low modulus, high strength, and high oxygen permeability.

[0006] Therefore, developing a novel silicone hydrogel material that achieves a balance between oxygen permeability, wearing comfort, and long-term stability has become an urgent technical need in this field. Summary of the Invention

[0007] The purpose of this invention is to provide a silicone hydrogel lens, its preparation method and application, which has both high oxygen permeability and comfort, and precise size, enabling long-term stable wear.

[0008] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a silicone hydrogel lens, wherein the raw materials for preparation, by weight percentage, include 20-60% hydrophilic monomer, 30-70% organosilicon monomer, 0.1-2% crosslinking agent, 0.1-2% initiator, and 5-20% additives; The hydrophilic monomers include at least two of the following: hydroxyethyl methacrylate, N-vinylpyrrolidone, N,N-dimethylacrylamide, methacrylic acid, and 2-methacryloyloxyethylphosphorylcholine. The organosilicon monomers include at least two of the following: hydroxyl-modified silicon monomers, low molecular weight silicon monomers, and high molecular weight silicon monomers.

[0009] Preferably, the hydroxyl-modified silicon monomer comprises one or more of trimethylsilanol, hydroxypropyl-terminated polydimethylsiloxane, (3-methacryloyloxy-2-hydroxypropoxy)propylbis(trimethylsiloxy)methylsilane, and 2-(trimethylsiloxy)ethyl methacrylate. The low molecular weight silicon monomers include one or more of the following: methacryloxypropyl monoterminated polydimethylsiloxane, allyltrimethylsilane, vinyltrimethoxysilane, vinyltriethoxysilane, and triisopropylsilyl methacrylate. The high molecular weight silicon monomer is one or more of the following: methacryloxypropyl dual-terminated polydimethylsiloxane, methacryloxypropyl tris(trimethylsiloxane)silane, and 3-acetoxy-2-hydroxypropoxypropyl-terminated polydimethylsiloxane.

[0010] Preferably, the crosslinking agent includes at least one selected from ethylene glycol dimethacrylate, triethylene glycol dimethacrylate, N,N'-methylenebisacrylamide, and trimethylolpropane trimethacrylate.

[0011] Preferably, the initiator includes at least one of azobisisobutyronitrile, azobisisoheptanenitrile, benzoyl peroxide, and 2,2'-azobis(2-methylpropanediamine) dihydrochloride.

[0012] Preferably, the additives include one or more of antioxidants, moisturizing lubricants, anti-deposition moisturizing additives, and wetting anti-deposition additives.

[0013] Preferably, the antioxidant includes 2,6-di-tert-butyl-p-cresol, the moisturizing lubricant includes sodium hyaluronate, the anti-deposition moisturizing aid includes polyvinylpyrrolidone, and the wetting and anti-deposition aid includes polyethylene glycol 400.

[0014] This invention provides a method for preparing the silicone hydrogel lens described in the above technical solution, comprising the following steps: Hydrophilic monomers, organosilicon monomers, crosslinking agents, initiators and additives are mixed, and after polymerization, the mixture is molded to obtain a lens molded body. After plasma treatment of the lens molded body, the resulting lens is extracted in purified water to obtain a silicone hydrogel lens.

[0015] Preferably, the polymerization reaction is carried out at a temperature of 80~130℃ for 1~3h; the plasma treatment conditions include: oxygen gas, power of 100~300 W, pressure of 0.5~5.0 Pa, and time of 60~180s.

[0016] Preferably, the extraction temperature is 90~95℃ and the time is 1~3h.

[0017] This invention provides the application of the silicone hydrogel lens described in the above technical solution or the silicone hydrogel lens prepared by the preparation method described in the above technical solution as a contact lens.

[0018] The beneficial effects of this invention are: This invention uses organosilicon monomers as the main body and adopts a composite formula system of "high oxygen permeability silicon matrix + hydrophilic functional monomers". It achieves the fusion of dual advantages through physical mixing process. The proportion of each core component has been accurately calculated and optimized. The formula proportion is precisely optimized to obtain a product system that combines oxygen permeability and comfort. Moreover, the size is accurate and it can be worn stably for a long time, providing consumers with a safe, comfortable and healthy vision correction option.

[0019] The silicone hydrogel lens provided by this invention has hydrophilic properties and a honeycomb structure, combining the high oxygen permeability of silicone materials with the softness of hydrogels. By copolymerizing organosilicon monomers and hydrophilic monomers, highly oxygen-permeable siloxane groups are introduced into the hydrogel material. The presence of numerous siloxane groups provides excellent channels for oxygen transfer, enabling oxygen to be transported through both the organosilicon phase and the hydrogel phase, thus improving the oxygen permeability of the silicone hydrogel material. Attached Figure Description

[0020] Figure 1 A photograph of the actual silicone hydrogel lens prepared in Example 1; Figure 2 This is a photograph of the silicone hydrogel lens prepared in Example 1, after being stretched and its length measured. Detailed Implementation

[0021] In this invention, unless otherwise specified, the raw materials or reagents required for preparation are all commercially available products well known to those skilled in the art.

[0022] In this invention, the mass percentage of each component is based on 100% of the total mass percentage of the silicone hydrogel lens.

[0023] This invention provides a silicone hydrogel lens, wherein the raw materials for preparation, by weight percentage, include 20-60% hydrophilic monomer, 30-70% organosilicon monomer, 0.1-2% crosslinking agent, 0.1-2% initiator, and 5-20% additives; The hydrophilic monomers include at least two of the following: hydroxyethyl methacrylate, N-vinylpyrrolidone, N,N-dimethylacrylamide, methacrylic acid, and 2-methacryloyloxyethylphosphorylcholine. The organosilicon monomers include at least two of the following: methacryloyloxypropyltris(trimethylsiloxane), (3-methacryloyloxy-2-hydroxypropoxy)propylbis(trimethylsiloxane), vinyltriethoxysilane, methacryloyloxypropyl mono-terminated polydimethylsiloxane, hydroxyl-modified silicon monomers, low molecular weight silicon monomers, and high molecular weight silicon monomers.

[0024] The raw materials for preparing the silicone hydrogel lens provided by the present invention, by weight percentage, include 20-60% hydrophilic monomers, preferably 30-55%, and more preferably 43-50%.

[0025] In this invention, the hydrophilic monomer includes at least two of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone, N,N-dimethylacrylamide, methacrylic acid, and 2-methacryloyloxyethylphosphorylcholine, more preferably 2-hydroxyethyl methacrylate and N-vinylpyrrolidone.

[0026] In this invention, when the hydrophilic monomers are two or more of the above-mentioned types, the proportion of different types of hydrophilic monomers is not particularly limited and can be adjusted according to needs; more preferably, it is 20-50% hydroxyethyl 2-methacrylate, 5-30% N-vinylpyrrolidone, 5-20% N,N-dimethylacrylamide, 3-10% methacrylic acid and 3-15% 2-methacryloyloxyethylphosphorylcholine.

[0027] In the hydrophilic monomers described in this invention, 2-hydroxyethyl methacrylate (HEMA) is used as the basic hydrophilic monomer. The HEMA molecule contains hydrophilic hydroxyl groups, which can improve the wettability of the lens surface, help the tear film to adhere stably, reduce friction between the lens and the cornea, reduce foreign body sensation, and at the same time improve the dryness problem caused by the hydrophobicity of pure organosilicon monomers, so that the silicone hydrogel lens has both high oxygen permeability and water-moisturizing properties.

[0028] NVP (N-vinylpyrrolidone), as a highly hydrophilic monomer, has extremely strong hydrophilicity and can significantly improve the lens's water absorption rate and oxygen permeability, further optimize tear film adhesion, and enhance wearing comfort. It is especially suitable for use with high-silica formulations to balance hydrophobic and hydrophilic properties and reduce lens dehydration and shrinkage.

[0029] DMAA (N,N-dimethylacrylamide), as a flexible hydrophilic monomer, has a flexible molecular structure that can reduce the glass transition temperature of lenses, improve lens flexibility and fit, reduce foreign body sensation during wear, and at the same time have good biocompatibility, which can reduce the risk of eye irritation.

[0030] MA (methacrylic acid), as a weakly acidic hydrophilic monomer, can precisely control the swelling and mechanical strength of the lens, optimize the lens forming precision, and enhance the slight adhesion between the lens and the cornea, thereby improving wearing stability.

[0031] MPC (2-methacryloyloxyethylphosphorylcholine) is a biomimetic hydrophilic monomer. The MPC molecular structure mimics the phospholipid groups of cell membranes, exhibiting excellent biocompatibility. It can form a hydration layer on the lens surface, significantly inhibiting the non-specific adhesion of proteins, lipids, and cells, greatly reducing the risk of lens deposition, while improving lens surface lubrication and wearing comfort, and reducing the probability of eye inflammation.

[0032] The raw materials for preparing the silicone hydrogel lens provided by the present invention, by weight percentage, include 30-70% organosilicon monomer, preferably 35-60%, and more preferably 40-50%.

[0033] In this invention, the organosilicon monomer preferably includes at least two of hydroxyl-modified silicon monomer, low molecular weight silicon monomer, and high molecular weight silicon monomer. When the organosilicon monomer is two or more of the above, this invention does not have a special limitation on the ratio of different types of organosilicon monomers, and can be adjusted according to needs; more preferably, it is 5-20% hydroxyl-modified silicon monomer, 10-25% low molecular weight silicon monomer, and 10-30% high molecular weight silicon monomer.

[0034] In this invention, the hydroxyl-modified silicon monomer preferably includes one or more of trimethylsilanol, hydroxypropyl-terminated polydimethylsiloxane, (3-methacryloyloxy-2-hydroxypropoxy)propylbis(trimethylsiloxy)methylsilane, and 2-(trimethylsiloxy)ethyl methacrylate. The low molecular weight silicon monomer preferably includes one or more of the following: methacryloxypropyl monoterminated polydimethylsiloxane, allyltrimethylsilane, vinyltrimethoxysilane, vinyltriethoxysilane, and triisopropylsilyl methacrylate. The high molecular weight silicon monomer is preferably a methacryloyloxypropyl dual-terminated polydimethylsiloxane, a methacryloyloxypropyl tris(trimethylsiloxane)silane, or a 3-acetoxy-2-hydroxypropoxypropyl-terminated polydimethylsiloxane.

[0035] In the organosilicon monomer of the present invention: Methacryloxypropyltris(trimethylsiloxane)silane (TRIS, CAS No. 17096-07-0) is a high molecular weight silicon monomer, belonging to the category of highly oxygen-permeable silicon monomers. TRIS contains a high silicon content structure, significantly improving lens oxygen permeability and effectively alleviating corneal hypoxia. It also enhances lens breathability and anti-aging properties. Furthermore, it can precisely control the lens's mechanical strength and elastic modulus, optimizing the lens-corneal fit.

[0036] (3-Methacryloxy-2-hydroxypropoxy)propylbis(trimethylsiloxy)methylsilane (SiGMMA, CAS No. 69861-02-5) contains hydroxyl-modified groups and is a hydroxyl-modified silicon monomer. As a balanced silicon monomer, it can balance the oxygen permeability and hydrophilicity of lenses, improve the surface lubricity of lenses, reduce the hydrophobic drawbacks of organosilicon monomers, and enhance the mechanical strength and molding stability of lenses. This monomer can enhance the hydrogen bonding force with hydrophilic monomers, improve the compatibility of silicon-hydrophilic components, inhibit phase separation, and at the same time, the hydroxyl groups can improve the surface wettability of lenses, balance the hydrophobic drawbacks of high-silica formulations, and improve oxygen permeability and comfort.

[0037] VTES (vinyltriethoxysilane) is a low molecular weight silicon monomer, belonging to the silane coupling type of silicon monomer. It can enhance the compatibility between silicon-containing components and hydrophilic components, inhibit phase separation during polymerization, improve lens transparency and uniformity, and optimize the mechanical stability of the lens.

[0038] Methacryloxypropyl mono-terminated polydimethylsiloxane (MCR-M11) is a low molecular weight silicon monomer with excellent flowability. It can improve the processing performance of the polymerization system, enhance lens molding uniformity, reduce lens modulus, and increase softness. When used in combination with high-silicon monomers, it balances lens oxygen permeability and wearing comfort. It can also precisely control the elastic modulus and flexibility of the lens, improving lens fit and synergistically enhancing oxygen permeability. It has good compatibility with hydrophilic monomers.

[0039] The raw materials for preparing the silicone hydrogel lens provided by the present invention, by weight percentage, include 0.1-2% crosslinking agent, preferably 0.4-1.5%, and more preferably 0.5-1.0%.

[0040] In this invention, the crosslinking agent preferably includes at least one selected from ethylene glycol dimethacrylate, triethylene glycol dimethacrylate, N,N'-methylenebisacrylamide, and trimethylolpropane trimethacrylate. When the crosslinking agent is two or more of the above, this invention does not have a special limitation on the ratio of different types of crosslinking agents, and any ratio is acceptable.

[0041] In the crosslinking agent of the present invention: EGDMA (ethylene glycol dimethacrylate) is a rigid crosslinking agent, preferably in the range of 0.2% to 3.0%. EGDMA can undergo crosslinking reactions with monomers to form a rigid crosslinking network, which effectively improves the mechanical strength and anti-swelling properties of the lens, reduces the swelling and deformation of the lens in tears, and ensures the stability of the lens shape and the accuracy of optical performance.

[0042] TEGDMA (triethylene glycol dimethacrylate) is a flexible crosslinking agent, preferably in the range of 0.2% to 3.5%. As a flexible crosslinking component, TEGDMA can build a flexible crosslinking network, improve the flexibility and elasticity of the lens, reduce the risk of lens breakage, and at the same time lower the glass transition temperature of the lens, thus improving wearing comfort.

[0043] MBA (N,N'-methylenebisacrylamide) is a highly efficient crosslinking agent, preferably at a ratio of 0.2% to 2.5%. MBA has high crosslinking efficiency and can quickly form a dense crosslinking network, significantly improving the lens's resistance to deformation and mechanical stability, reducing the lens swelling rate, and ensuring that the lens does not change shape during long-term use, making it suitable for lenses worn for extended periods.

[0044] TMPTMA (trimethylolpropane trimethacrylate) is a highly active crosslinking agent, preferably in the range of 0.4% to 2.8%. TMPTMA has high polymerization activity and can quickly form a dense crosslinking network with hydrophilic and silicon monomers, effectively improving the dimensional stability and tear resistance of lenses and reducing the risk of deformation during wear.

[0045] The raw materials for preparing the silicone hydrogel lens provided by the present invention, by weight percentage, include 0.1-2% initiator, preferably 0.5-1.5%, and more preferably 0.6-1.0%.

[0046] In this invention, the initiator preferably includes at least one selected from azobisisobutyronitrile, azobisisoheptanenitrile, benzoyl peroxide, and 2,2'-azobis(2-methylpropanediamine) dihydrochloride. When the initiator is two or more of the above, this invention does not have a special limitation on the ratio of different types of initiators, and any ratio is acceptable.

[0047] In the initiator described in this invention: AIBN (azobisisobutyronitrile) is a low-temperature thermal initiator, preferably with a proportion of 0.1~1.0%. When heated, AIBN can decompose steadily to generate free radicals, which can initiate the polymerization reaction of hydrophilic monomers and silicon monomers. The reaction process is mild and easy to control, which can improve the uniformity of the polymerization reaction, reduce the internal stress of the lens, and ensure the stable quality of lens molding.

[0048] ADVN (azobisisoheptanenitrile) is a medium-to-high temperature thermal initiator, preferably with a proportion of 0.1% to 1.0%. When heated, it slowly decomposes to generate free radicals, resulting in a gentler exothermic reaction during polymerization. This reduces the problems of lens bubbles and yellowing caused by local overheating in the polymerization system, and improves the optical uniformity of the lens.

[0049] BPO (benzoyl peroxide) is a thermal initiator, preferably at a concentration of 0.2-1.2%. BPO has a moderate decomposition temperature, making it suitable for high-temperature polymerization processes. It can significantly improve the polymerization conversion rate, ensure sufficient monomer reaction, enhance the crosslinking density of the lens, improve the mechanical strength of the lens, and reduce the risk of lens deformation.

[0050] AAPH (2,2'-azobis(2-methylpropanediamine) dihydrochloride) is a water-soluble thermal initiator, preferably in a proportion of 0.1-0.9%. AAPH is a water-soluble thermal initiator with good biocompatibility, suitable for aqueous polymerization systems of hydrophilic monomers, can avoid organic solvent residues, improve the safety of wearing lenses, and at the same time, the initiation reaction is stable, ensuring uniform lens performance.

[0051] The raw materials for preparing the silicone hydrogel lens provided by the present invention, by weight percentage, include 5-20% additives, preferably 6-18%, and more preferably 9-15%.

[0052] In this invention, the additives include one or more of antioxidants, moisturizing lubricants, anti-deposition moisturizing additives, and wetting anti-deposition additives. When the additives are two or more of the above, this invention does not have a special limitation on the ratio of different types of additives, and can be adjusted according to needs. More preferably, the ratio is 0.1-1.0% antioxidant, 0.1-2.5% moisturizing lubricant, 0.3-4% anti-deposition moisturizing additive, and 0.5-5% wetting anti-deposition additive.

[0053] In this invention, the antioxidant preferably includes 2,6-di-tert-butyl-p-cresol (BHT), which effectively prevents monomer oxidative degradation during polymerization, improves material storage stability, and at the same time avoids aging and yellowing of finished lenses during use, extends lens lifespan, and ensures stable optical performance.

[0054] In this invention, the moisturizing lubricant preferably includes sodium hyaluronate (HA). HA has extremely strong moisturizing and lubricating properties, which can enhance the hydration of the lens surface, help the tear film adhere stably, relieve dryness and foreign body sensation after long-term wear, and at the same time improve the biocompatibility of the lens and reduce the risk of eye allergies.

[0055] In this invention, the anti-deposition moisturizing agent preferably includes polyvinylpyrrolidone (PVP). PVP can adsorb protein molecules in tears, reduce protein deposition on the lens surface, avoid decreased lens transparency and eye irritation, and at the same time have a certain moisturizing property, thus synergistically improving wearing comfort.

[0056] In this invention, the wetting and anti-deposition aid preferably includes polyethylene glycol 400 (PEG400). PEG400 is a low molecular weight polyethylene glycol derivative that has both hydrophilicity and lubricity. It can form a hydration protective film on the lens surface, enhance tear film spreadability, reduce the adsorption and deposition of proteins and lipids on the lens surface, and improve the lubrication and fit between the lens and the cornea, thereby relieving the dryness and discomfort caused by prolonged wear.

[0057] This invention provides a method for preparing the silicone hydrogel lens described in the above technical solution, comprising the following steps: Hydrophilic monomers, organosilicon monomers, crosslinking agents, initiators and additives are mixed, and after polymerization, the mixture is molded to obtain a lens molded body. After plasma treatment of the lens molded body, the resulting lens is extracted in purified water to obtain a silicone hydrogel lens.

[0058] The present invention does not impose any special limitations on the mixing process; it can be carried out according to a process known in the art.

[0059] In this invention, the temperature of the polymerization reaction is preferably 80~130℃, more preferably 90~120℃, even more preferably 100~110℃, and the time is preferably 1~3h, more preferably 1.5~2h.

[0060] The present invention does not have any special limitations on the molding process, and can be carried out according to the process known in the art.

[0061] In this invention, the plasma treatment conditions preferably include: oxygen gas, power of 100-300 W, more preferably 150-200 W, pressure of 0.5-5.0 Pa, more preferably 2-3 Pa, and time of 60-180 s, more preferably 100-150 s. This invention uses active particles generated by plasma ionization of gas to bombard the lens surface, introducing hydrophilic polar groups (such as -OH hydroxyl groups and -COOH carboxyl groups) at the nanoscale, significantly improving surface wettability, reducing deposit adsorption, and making wearing more comfortable.

[0062] In this invention, the extraction temperature is 90~95℃, more preferably 95℃, and the extraction time is preferably 1~3h, more preferably 2h.

[0063] This invention provides the application of the silicone hydrogel lens described in the above technical solution or the silicone hydrogel lens prepared by the preparation method described in the above technical solution as a contact lens.

[0064] The specific embodiments of the present invention are described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. 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.

[0065] Unless otherwise specified, the experimental methods described in the various embodiments of this invention are conventional methods; unless otherwise specified, the reagents and raw materials described below are all commercially available.

[0066] Example 1

[0067] The silicone hydrogel lens provided in this embodiment is prepared by means of 55% hydrophilic monomer, 35% organosilicon monomer, 0.5% crosslinking agent, 0.5% initiator, and 9% additives by weight percentage. The hydrophilic monomers are 20% hydroxyethyl 2-methacrylate, 10% N-vinylpyrrolidone, 5% N,N-dimethylacrylamide, 10% methacrylic acid, and 10% 2-methacryloyloxyethyl phosphorylcholine. The organosilicon monomers are 15% hydroxyl-modified silicon monomers (10% trimethylsilanol, 5% hydroxypropyl-terminated polydimethylsiloxane), 10% low molecular weight silicon monomers (methacryloyloxypropyl mono-terminated polydimethylsiloxane), and 10% high molecular weight silicon monomers (methacryloyloxypropyl tris(trimethylsiloxane)silane). The crosslinking agents are 0.3% ethylene glycol dimethacrylate and 0.2% N,N'-methylenebisacrylamide; The initiator is 0.4% azobisisobutyronitrile and 0.1% 2,2'-azobis(2-methylpropanediamine) dihydrochloride; The additives are: 1% sodium hyaluronate (HA) as a moisturizing lubricant, 4% polyvinylpyrrolidone (PVP) as an anti-deposition moisturizing agent, and 4% polyethylene glycol 400 (PEG400) as a wetting and anti-deposition agent.

[0068] The method for preparing the silicone hydrogel lens is as follows: The hydrophilic monomer, organosilicon monomer, crosslinking agent, initiator and additives are mixed, polymerized at 100℃ for 2 hours, and then molded to obtain the lens molded body. The lens molded body was treated with oxygen plasma at a power of 200 W, a pressure of 2.0 Pa, and a time of 100 s. The resulting lens was then extracted in purified water at a temperature of 95 °C for 2 h to obtain a silicone hydrogel lens.

[0069] Example 2

[0070] The silicone hydrogel lens provided in this embodiment is prepared by means of 43% hydrophilic monomer, 50% organosilicon monomer, 0.4% crosslinking agent, 0.6% initiator, and 6% additives by weight percentage. The hydrophilic monomers are 23% hydroxyethyl 2-methacrylate, 5% N-vinylpyrrolidone, 10% N,N-dimethylacrylamide, and 5% 2-methacryloyloxyethyl phosphorylcholine. The organosilicon monomers consist of 15% hydroxyl-modified silicon monomers (2-(trimethylsiloxy)ethyl methacrylate), 25% low molecular weight silicon monomers (10% allyltrimethylsilane and 15% triisopropylsilyl methacrylate), and 10% high molecular weight silicon monomers (3-acetoxy-2-hydroxypropoxypropyl-terminated polydimethylsiloxane). The crosslinking agents are 0.2% ethylene glycol dimethacrylate and 0.2% triethylene glycol dimethacrylate; The initiators are 0.3% azobisisobutyronitrile and 0.3% azobisisoheptanenitrile; The additives are sodium hyaluronate (HA) as a moisturizing and lubricating agent at 1% and polyethylene glycol 400 (PEG400) as a wetting and anti-deposition agent at 5%. The method for preparing the silicone hydrogel lens is as follows: The hydrophilic monomer, organosilicon monomer, crosslinking agent, initiator and additives are mixed, polymerized at 100℃ for 2 hours, and then molded to obtain the lens molded body. The lens molded body was treated with oxygen plasma at a power of 200 W, a pressure of 2.0 Pa, and a time of 100 s. The resulting lens was then extracted in purified water at a temperature of 95 °C for 2 h to obtain a silicone hydrogel lens.

[0071] Performance testing

[0072] 1) Figure 1 A photograph of the actual silicone hydrogel lens prepared in Example 1; as shown. Figure 1 As shown, the silicone hydrogel lenses have a naturally clear, light blue tint, not a heavy artificial color, but a uniform and natural light blue tone that is both aesthetically pleasing and practical. The light blue makes the lenses easily visible in contact lens solution, allowing for easy removal. Once in the eye, they blend naturally with the whites of the eyes, appearing completely invisible without being obtrusive or giving the unnatural "colored contact lens" look. The clear texture combined with the light blue not only enhances visibility during handling but also provides comfort and a beautiful appearance for everyday wear.

[0073] 2) Figure 2 This is a photograph of the silicone hydrogel lens prepared in Example 1, taken after stretching and measuring its length. Figure 2 As shown, silicone hydrogel lenses are flexible and can be stretched to 20% of their original length. They are not difficult to wear due to excessive softness. Once in the eye, they fit snugly along the corneal curvature, and there is no foreign body sensation or slippage when blinking. They are also not easily torn.

[0074] 3) Silicone hydrogel lenses achieve precise batch-wide control over two core fitting parameters: diameter and base curve, with test results showing 100% compliance with wearing standards. The lens diameter is strictly controlled within the golden range of 13.80~14.20mm, fitting the eye shapes of most Asians, ensuring a snug fit without pinching or slipping. The base curve is precisely adjusted to 8.4~8.8mm, perfectly matching the corneal curvature, ensuring a stable attachment and preventing lens detachment while avoiding slippage caused by an excessively tight base curve pressing on the cornea or an excessively loose base curve. Each batch of lenses undergoes individual optical testing, with diameter and base curve deviations controlled within ±0.2mm, ensuring a comfortable fit and clear vision after wearing, fundamentally eliminating problems such as foreign body sensation, soreness, and tearing caused by parameter mismatches.

[0075] 4) Test the oxygen permeability coefficient of the silicone hydrogel lens to verify the oxygen permeability of the lens. The results are shown in Table 1.

[0076] Table 1. Test data of silicone hydrogel lenses in Examples 1-2

[0077] As shown in Table 1, the oxygen permeability increases with the percentage of organosilicon monomers, from low to high. At a organosilicon monomer percentage of 35%, the oxygen permeability coefficient is 48.829 × 10⁻⁶. -11 (cm 2 / s)[mlO2 / (ml·hPa); Organosilicon monomer content is 50%, oxygen permeability coefficient is 135.919× 10 -11 (cm 2 / s)[mlO2 / (ml·hPa), indicating that the silicone hydrogel lens provided by the present invention has high oxygen permeability.

[0078] 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 silicone hydrogel lens, characterized in that, The raw materials, by mass percentage, include 20-60% hydrophilic monomers, 30-70% organosilicon monomers, 0.1-2% crosslinking agents, 0.1-2% initiators, and 5-20% additives. The hydrophilic monomers include at least two of the following: hydroxyethyl methacrylate, N-vinylpyrrolidone, N,N-dimethylacrylamide, methacrylic acid, and 2-methacryloyloxyethylphosphorylcholine. The organosilicon monomers include at least two of the following: hydroxyl-modified silicon monomers, low molecular weight silicon monomers, and high molecular weight silicon monomers.

2. The silicone hydrogel lens according to claim 1, characterized in that, The hydroxyl-modified silicon monomer includes one or more of trimethylsilanol, hydroxypropyl-terminated polydimethylsiloxane, (3-methacryloyloxy-2-hydroxypropoxy)propylbis(trimethylsiloxy)methylsilane, and 2-(trimethylsiloxy)ethyl methacrylate; The low molecular weight silicon monomers include one or more of the following: methacryloxypropyl monoterminated polydimethylsiloxane, allyltrimethylsilane, vinyltrimethoxysilane, vinyltriethoxysilane, and triisopropylsilyl methacrylate. The high molecular weight silicon monomer is one or more of the following: methacryloxypropyl dual-terminated polydimethylsiloxane, methacryloxypropyl tris(trimethylsiloxane)silane, and 3-acetoxy-2-hydroxypropoxypropyl-terminated polydimethylsiloxane.

3. The silicone hydrogel lens according to claim 1, characterized in that, The crosslinking agent includes at least one of ethylene glycol dimethacrylate, triethylene glycol dimethacrylate, N,N'-methylenebisacrylamide, and trimethylolpropane trimethacrylate.

4. The silicone hydrogel lens according to claim 1, characterized in that, The initiator includes at least one of azobisisobutyronitrile, azobisisoheptanenitrile, benzoyl peroxide, and 2,2'-azobis(2-methylpropanediamine) dihydrochloride.

5. The silicone hydrogel lens according to claim 1, characterized in that, The additives include one or more of antioxidants, moisturizing lubricants, anti-deposition moisturizing additives, and wetting anti-deposition additives.

6. The silicone hydrogel lens according to claim 5, characterized in that, The antioxidant includes 2,6-di-tert-butyl-p-cresol, the moisturizing lubricant includes sodium hyaluronate, the anti-deposition moisturizing aid includes polyvinylpyrrolidone, and the wetting and anti-deposition aid includes polyethylene glycol 400.

7. The method for preparing the silicone hydrogel lens according to any one of claims 1 to 6, characterized in that, Includes the following steps: Hydrophilic monomers, organosilicon monomers, crosslinking agents, initiators and additives are mixed, and after polymerization, the mixture is molded to obtain a lens molded body. After plasma treatment of the lens molded body, the resulting lens is extracted in purified water to obtain a silicone hydrogel lens.

8. The preparation method according to claim 1, characterized in that, The polymerization reaction is carried out at a temperature of 80~130℃ for 1~3h; the plasma treatment conditions include: oxygen gas, power of 100~300 W, pressure of 0.5~5.0 Pa, and time of 60~180s.

9. The preparation method according to claim 1, characterized in that, The extraction temperature is 90~95℃, and the time is 1~3h.

10. The application of the silicone hydrogel lens according to any one of claims 1 to 5 or the silicone hydrogel lens prepared by the preparation method according to any one of claims 6 to 8 as a contact lens.

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