A neutralizing hydrogen peroxide solution for contact lenses, its preparation method and usage method

Abstract

This invention relates to the field of medical solution preparation technology. Addressing the problems of incomplete and slow neutralization processes in traditional hydrogen peroxide contact lens solutions, which lead to eye irritation risks and low care efficacy, this invention specifically discloses a neutralized hydrogen peroxide contact lens solution, its preparation method, and its usage method. The solution comprises: 2.0-4.0% (w / v) hydrogen peroxide, 0.01-0.5% (w / v) poloxamer, 0.01-0.1% (w / v) diethylenetriaminepentamethylphosphonic acid, and 0.001-0.01% (w / v) UCNP@TiO2 nanomaterials, with the remainder being a buffer system, an osmotic pressure regulator, and purified water. The UCNP@TiO2 nanomaterials are a core-shell composite material with a lanthanide-doped upconversion nanomaterial core and a titanium dioxide shell. This invention introduces UCNP@TiO2 nanomaterials into the nursing solution. Under near-infrared light irradiation, this material can instantly generate a significant killing effect on microorganisms and can also rapidly and completely decompose hydrogen peroxide into water and oxygen, achieving a nursing effect of active light-controlled triggering for disinfection and sterilization.

Description

Technical Field

[0001] This invention relates to the field of medical preparation technology, and more specifically, to a neutralized hydrogen peroxide solution for contact lenses, its preparation method, and its usage method. Background Technology

[0002] Hydrogen peroxide contact lens solution is a medical-grade solution used for disinfection and sterilization of contact lenses. It relies on the strong oxidizing properties of hydrogen peroxide to achieve sterilization and disinfection, while also aiding in cleaning and protein removal, ultimately eliminating residual irritation through a neutralization reaction. However, traditional hydrogen peroxide contact lens solutions have two inherent technical drawbacks: firstly, the disinfection cycle is long, typically requiring 6 hours or more to achieve a sufficiently thorough sterilization effect; secondly, the neutralization reaction is dependent on and uncertain, as the neutralization process almost entirely depends on the chemical catalysis of platinum rings or neutralizing tablets. Platinum rings age and become ineffective, while neutralizing tablets involve cumbersome processing steps of adding and waiting, and incomplete neutralization can lead to serious eye irritation risks.

[0003] Currently, to improve or solve the above two problems, the corresponding effects are often enhanced by optimizing the existing system. For example, patent CN114891576A proposes a corneal contact lens care solution, its preparation method, and its application. The care solution includes a liquid component (care solution) and a solid component with a delayed-release coating (neutralizer). By compounding different surfactants and improving the added neutralizer, the negative effects of hydrogen peroxide care solution can be mitigated and reduced.

[0004] However, existing contact lens care solutions, such as those mentioned above, are inherently affected by the mode of action and working principle of the neutralizing agent. The degree and speed of the neutralization process cannot be fully controlled. That is, although the neutralization reaction process has been improved, it still cannot fundamentally or completely avoid the problems of incomplete and slow neutralization. There are still certain defects such as the risk of eye irritation and low care efficacy. Summary of the Invention

[0005] The purpose of this invention is to solve the problems of eye irritation risk and low care efficacy caused by the incomplete and slow neutralization process of traditional hydrogen peroxide contact lens solutions.

[0006] This invention is achieved through the following technical solution: This invention provides a neutralizing hydrogen peroxide solution for contact lenses, comprising the following components: 2.0-4.0% (w / v) hydrogen peroxide, 0.01-0.5% (w / v) poloxamer 17R4, 0.01-0.1% (w / v) diethylenetriaminepentimidephosphonic acid (DTPMPA), 0.001-0.01% (w / v) UCNP@TiO2 nanomaterials, buffer system and osmotic pressure regulator, balance being purified water.

[0007] Among them, UCNP@TiO2 nanomaterials are based on lanthanide-doped upconversion nanomaterials (UCNP) as the core and titanium dioxide (TiO2) as the outermost nanomaterial. 2 This refers to a core-shell structured composite material with a ytterbium-thulium-doped sodium yttrium fluoride upconversion nanomaterial as the core, whose general chemical formula can be written as NaYF4:Yb. 3+ ,Tm 3+ .

[0008] Preferably, the preparation method of UCNP@TiO2 nanomaterials includes the following steps: (1) First, synthesize lanthanide-doped upconversion nanomaterials as the core: Weigh out powders of yttrium oxide (Y2O3), ytterbium oxide (Yb2O3), and thulium oxide (Tm2O3), and dissolve them separately in excess dilute nitric acid. Heat and stir until completely dissolved to form a transparent rare earth nitrate solution. Then evaporate and crystallize to remove excess acid and water to obtain solid rare earth nitrates. Redissolve the solids in deionized water to prepare mother liquors of yttrium nitrate (Y(NO3)3), ytterbium nitrate (Yb(NO3)3), and thulium nitrate (Tm(NO3)3).

[0009] According to the doping concentration specified in the product, using NaYF4:20%Yb 3+ 2%Tm 3+ For example, the above-mentioned yttrium nitrate mother liquor, ytterbium nitrate mother liquor, and thulium nitrate mother liquor are accurately measured and added to the polytetrafluoroethylene (PTFE) liner of the reactor, and mixed to obtain a mixed rare earth solution; then, excess sodium fluoride (NaF) and / or ammonium fluoride (NH4F) are added to the PTFE liner containing the mixed rare earth solution as a fluorine source, and the amount added is usually according to RE 3+ :F -The molar ratio is 1:4-10, and an appropriate amount of sodium citrate and / or EDTA is added as a complexing stabilizer. Stir continuously for 10-60 minutes to ensure thorough mixing. Place the PTFE-lined container in a high-pressure reactor, seal it, and then place the reactor in a forced-air dryer. React at 160-220℃ for 6-24 hours. After the reaction, allow it to cool naturally to room temperature. Open the reactor and centrifuge the resulting milky white suspension at 8000-12000 rpm for 5-10 minutes. Collect the precipitate and wash it several times alternately with anhydrous ethanol and deionized water to thoroughly remove residual ions and impurities. Then, place the washed product in a vacuum drying oven and dry at 60-80℃ for 6-12 hours to obtain pure phase, uniformly sized NaYF4:Yb. 3+ ,Tm 3+ Upconversion nanomaterials are nanoscale particles with a particle size typically controlled below 100 nm. This size can be controlled by adjusting the concentration, ratio, and hydrothermal conditions of the aforementioned reactants to meet the requirements for suspension and dispersion in the nursing solution.

[0010] (2) Using the sol-gel method, a titanium dioxide shell was coated on the core surface to prepare UCNP@TiO2 nanomaterials: The upconversion nanomaterials prepared in the above steps are dispersed in a mixed solution of anhydrous ethanol and water, with the volume ratio of anhydrous ethanol to water controlled at approximately 3-5:1. The solution is then sonicated for 30-60 minutes using a probe sonicator to prepare a uniform and stable core suspension with a concentration of 1-5 mg / mL.

[0011] Take the core suspension and slowly add a solution of tetrabutyl titanate (TBOT) in ethanol dropwise under vigorous stirring. The amount of TBOT is determined according to the required TiO2 shell thickness, specifically controlled within a mass ratio of core to TiO2 shell of 1:0.5-2. After the addition is complete, continue stirring the mixture for 12-24 hours. During this process, TBOT slowly hydrolyzes and undergoes a condensation reaction on the core surface, forming an amorphous TiO2 hydrate gel layer, thus achieving shell coating. After the reaction is complete, centrifuge at 8000-12000 rpm for 5-10 minutes, collect the coated nanocomposite precipitate, and wash the precipitate several times alternately with anhydrous ethanol and deionized water to remove unreacted titanium source and byproducts. Then, place the washed product in a vacuum drying oven. The raw material is dried at 60-80℃ for 6-12 hours to obtain a preliminary powder. Finally, the preliminary powder is placed in a muffle furnace or tube furnace and heated to 500℃ at a heating rate of 2-5℃ / min in an air atmosphere, and held at that temperature for 2 hours for calcination and crystallization. Then, it is naturally cooled to room temperature. During this process, the amorphous TiO2 is transformed into anatase crystal form, thereby obtaining a well-crystallized UCNP@TiO2 nanomaterial with a core-shell structure and high photocatalytic activity. By controlling the amount of titanium source and hydrolysis conditions, a TiO2 shell layer of a certain thickness can be formed on the core surface. The thickness of the TiO2 shell layer is usually around 5-15nm, so that the overall particle size of the material is kept in the nanoscale range, preferably below 100nm, thereby ensuring its good dispersion stability in aqueous solution.

[0012] Preferably, the buffer system includes anhydrous disodium hydrogen phosphate, and / or sodium dihydrogen phosphate monohydrate, and / or phosphoric acid, and the buffer system is added to adjust the pH of the system to be stable in the range of 6.5-7.5.

[0013] Preferably, sodium chloride can be selected as the osmotic pressure regulator to adjust the osmotic pressure of the system to 250-320 mOsm / kg.

[0014] The present invention also provides a method for preparing the above-mentioned neutralized hydrogen peroxide solution for contact lenses, comprising the following steps: (1) Preparation of UCNP@TiO2 nanomaterial dispersion: Based on the total volume of the neutralized contact lens hydrogen peroxide treatment solution, take 10-20% purified water. Then, according to the formula, accurately weigh the UCNP@TiO2 nanomaterials and add them to the purified water. Place the solution in an ice-water bath and use a probe-type ultrasonic disruptor with a power setting of 200-400W. Immerse the ultrasonic probe about 1cm below the liquid surface for ultrasonic treatment. Specifically, use an intermittent ultrasonic mode, such as alternating between turning the ultrasonic on for 2-3 seconds and turning it off for 1-2 seconds. The total ultrasonic treatment time is 10-20 minutes, until the liquid in the container appears translucent or slightly opalescent to the naked eye, and there are no visible sediments at the bottom of the container. This yields a uniform and stable UCNP@TiO2 nanomaterial dispersion.

[0015] (2) Preparation of neutralizing hydrogen peroxide solution for contact lenses: According to the formula, take poloxamer 17R4, DTPMPA, buffer system, and osmotic pressure regulator, dissolve them in the remaining purified water, and stir evenly; then, under low temperature of 15-25℃ and stirring conditions, add hydrogen peroxide according to the formula and stir evenly; finally, add UCNP@TiO2 nanomaterial dispersion, mix evenly, and measure and adjust the pH value of the system to the range of 6.5-7.5 to obtain the neutralized hydrogen peroxide care solution for contact lenses.

[0016] The method of using the neutralized hydrogen peroxide solution for contact lenses in this invention involves immersing the contact lenses in the neutralized hydrogen peroxide solution, irradiating them with near-infrared light at a wavelength of 980±10nm for 1-15 minutes, then removing the contact lenses, rinsing them, and then wearing them.

[0017] The technical solution of the present invention has the following beneficial effects: This invention innovatively introduces photocatalytically active UCNP@TiO2 nanomaterials into traditional contact lens solutions. Under near-infrared light irradiation, this material converts light energy into ultraviolet light, activating TiO2 to produce a strong photocatalytic effect. This effect not only instantly and significantly enhances the killing efficacy against microorganisms but also rapidly and thoroughly decomposes hydrogen peroxide into water and oxygen. This transforms the passive disinfection and neutralization of traditional contact lens solutions into active, light-controlled triggering, thus solving the technical problems of long disinfection times and incomplete neutralization in traditional contact lens solutions. It achieves a significant increase in disinfection efficiency and rapid, thorough neutralization of hydrogen peroxide, while also maintaining extremely high safety.

[0018] To elaborate, traditional contact lens solutions require disinfection times of up to 6 hours. However, the UCNP@TiO2 nanomaterials introduced in this invention possess a certain catalytic disinfection effect in a hydrogen peroxide environment. When users need to completely disinfect and care for their contact lenses in a short time, they can immerse the lenses in the neutralized hydrogen peroxide solution proposed in this invention and irradiate them under a specific wavelength of near-infrared light for several tens of minutes. The UCNP core can convert the absorbed near-infrared light into ultraviolet light and transfer it to the TiO2 shell. The TiO2 is excited by the ultraviolet light to generate highly oxidizing hole-electron pairs, which instantly and greatly catalyze and enhance the decomposition of hydrogen peroxide to generate a large number of hydroxyl radicals, achieving a bombardment-style efficient killing of microorganisms and shortening the disinfection time from 6 hours to a few minutes to several tens of minutes.

[0019] In addition, the photocatalytic process described above not only powerfully sterilizes, but also rapidly and thoroughly decomposes hydrogen peroxide into water and oxygen. Therefore, users no longer need to rely on platinum rings or neutralizing tablets. The neutralization process can be actively controlled by the user, and the user can judge whether the neutralization reaction has ended and whether the sterilization care has been thorough by observing the cessation of bubble production.

[0020] The UCNP@TiO2 nanomaterial used in this invention has a UCNP core with good biocompatibility and a TiO2 shell that is a safe photocatalyst. By combining the two to form a specific core-shell structure, it is introduced into a neutralized hydrogen peroxide contact lens solution at an extremely low concentration. While achieving the above-mentioned effects, the UCNP core is completely encapsulated in the shell, preventing leakage into the solution. It will eventually settle at the bottom of the container containing the solution and be removed during rinsing, thus avoiding contact with the contact lenses and the user's eyes. Attached Figure Description

[0021] Figure 1 This is a schematic diagram illustrating the working principle of the UCNP@TiO2 nanomaterial in this invention; Figure 2 The graph shows the change in hydrogen peroxide concentration over time of the nursing solution in Example 1 under 980nm NIR light irradiation. Figure 3 The graph shows the change in the logarithmic kill rate of different bacterial species by the nursing solution in Example 1 after NIR light irradiation treatment over time. Figure 4 This is a schematic diagram illustrating the usage process of the neutralized hydrogen peroxide care solution for contact lenses in this invention. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, they are performed according to conventional conditions or conditions recommended by the manufacturer; where the manufacturers of the instruments, equipment, reagents, or raw materials used are not specified, they are all conventional products that can be purchased commercially.

[0023] Example 1 This embodiment uses the preparation method proposed in this invention to prepare a contact lens care solution. The specific process is as follows: (1) Synthesis and preparation of UCNP@TiO2 nanomaterial dispersion: Y₂O₃, Yb₂O₃, and Tm₂O₃ powders were weighed separately and dissolved in excess dilute nitric acid. The solution was heated and stirred until completely dissolved. Excess nitric acid was then removed by evaporation and crystallization. The dissolved powders were then thoroughly dissolved in deionized water to prepare Y(NO₃)₃, Yb(NO₃)₃, and Tm(NO₃)₃ mother liquors. These three rare earth mother liquors were added to the polytetrafluoroethylene (PTFE) liner of the reaction vessel and mixed to obtain a mixed rare earth solution. Then, the mixed rare earth solution was added to the PTFE liner containing the PTFE liner, typically according to RE... 3+ :F - The molar ratio was 1:7. Excess sodium fluoride and an appropriate amount of sodium citrate were added, and the mixture was stirred continuously for 30 minutes. The polytetrafluoroethylene liner was placed in a high-pressure reactor, sealed, and then the reactor was placed in a forced-air dryer. The reaction was carried out at 190°C for 15 hours. After the reaction was completed, the mixture was allowed to cool naturally to room temperature. The reactor was opened, and the resulting milky white suspension was centrifuged at 10,000 rpm for 8 minutes. The precipitate was collected and washed several times with anhydrous ethanol and deionized water alternately to thoroughly remove residual ions and impurities. The washed product was then placed in a vacuum drying oven and dried at 70°C for 9 hours to obtain NaYF4:Yb. 3+ ,Tm 3+ Upconversion nanomaterials.

[0024] NaYF4:Yb 3+ ,Tm 3+Upconversion nanomaterials were dispersed in a mixture of anhydrous ethanol and water at a volume ratio of 4:1 and sonicated for 45 min using a probe sonicator to prepare a core suspension with a concentration of 3 mg / mL. Then, under vigorous stirring, an ethanol solution of tetrabutyl titanate (TBOT) was slowly added dropwise at a core-to-TiO2 shell mass ratio of 1:1. After the addition was complete, the mixture was stirred for 18 h. After the reaction was completed, the mixture was centrifuged at 10,000 rpm for 8 min to collect the coated nanocomposite precipitate. The precipitate was washed several times with anhydrous ethanol and deionized water alternately, and then placed in a vacuum drying oven and dried at 70 °C for 9 h. Finally, it was transferred to a muffle furnace and heated to 500 °C at a heating rate of 3.5 °C / min under air atmosphere and held at that temperature for 2 h for calcination crystallization. After natural cooling to room temperature, UCNP@TiO2 nanomaterials were obtained.

[0025] Based on the total volume of the neutralized contact lens hydrogen peroxide treatment solution, take 15% purified water and place the UCNP@TiO2 nanomaterials in the purified water. Then place it in an ice-water bath environment and use a probe-type ultrasonic disruptor with a power setting of 300W. Immerse the ultrasonic probe about 1cm below the liquid surface for ultrasonic treatment. Use an intermittent ultrasonic mode, alternating between turning the ultrasonic on for 2-3 seconds and turning it off for 1-2 seconds. The total ultrasonic treatment time is 15 minutes to obtain a UCNP@TiO2 nanomaterial dispersion.

[0026] (2) Preparation of contact lens solution: According to the following prepared raw material components, take 3.0% (w / v) hydrogen peroxide, 0.1% (w / v) poloxamer 17R4, 0.05% (w / v) DTPMPA, 0.005% (w / v) UCNP@TiO2 nanomaterials, an appropriate amount of phosphate buffer system, an appropriate amount of sodium chloride, and the remaining purified water. The amount of phosphate buffer system is sufficient to adjust the pH of the system to 7.0, and the amount of sodium chloride is sufficient to adjust the osmotic pressure to 290 mOsm / kg. First, dissolve poloxamer 17R4, DTPMPA, phosphate buffer system, and sodium chloride in purified water and stir until homogeneous. Then, under low temperature (approximately 20°C) and stirring conditions, add hydrogen peroxide. Next, while stirring, add the UCNP@TiO2 nanomaterial dispersion, mix thoroughly, and adjust the pH to approximately 7.0 to obtain the care solution.

[0027] Comparative Example 1 The difference between this comparative example and Example 1 is that it does not contain UCNP@TiO2 nanomaterials, while the composition and relative amounts of the other raw materials remain unchanged.

[0028] Test case (1) Light-triggered neutralization rate test Test method: Take 10 mL of the care solution from Example 1 and place it in a transparent glass bottle. Use a 980 nm near-infrared laser and set the power density to 1 W / cm². 2 The liquid surface was irradiated vertically at a distance of 10 cm. Samples of the cleaning solution were taken at 0, 1, 3, 5, 7 and 10 min of irradiation. At the same time, another sample of the same cleaning solution was taken as a control group without NIR irradiation. The concentration of residual hydrogen peroxide was determined by potassium permanganate titration.

[0029] The data obtained from the above tests are summarized as follows: Figure 2 As shown in the test, the hydrogen peroxide concentration in the unirradiated contact lens solution sample decreased slowly, while the hydrogen peroxide in the NIR-irradiated solution sample was completely decomposed within 10 minutes. This proves that the neutralized hydrogen peroxide solution for contact lenses proposed in this invention can achieve rapid and active neutralization after near-infrared light irradiation, achieving efficient and rapid sterilization through hydrogen peroxide decomposition.

[0030] (2) Photocatalytic Enhancement of Disinfection Efficiency Test Test Method: The care solutions prepared in Example 1 and Comparative Example 1 were used as the irradiation group and control group, respectively. Several portions of the samples from both groups were taken, and a certain amount of suspensions of Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 9027), Candida albicans (ATCC 10231), and Fusarium moniliforme (ATCC 36031) were added to each group, controlling the initial concentration to be approximately 1×10⁻⁶. 6 CFU / mL; then, the irradiated group underwent 980nm NIR (1W / cm²). 2 The control group received irradiation for 10 minutes, while the control group received no irradiation. Samples of the nursing solution were taken at 0 (right after irradiation), 1, 2, 4, and 6 hours after irradiation, and the kill log value at each time point was calculated using the plate count method.

[0031] The data obtained from the above tests are summarized as follows: Figure 3 As shown, this test reveals the following: 2.1 Staphylococcus aureus (Gram-positive bacteria): Example 1 is the NIR irradiation group. After 10 minutes of NIR irradiation, the kill log value at 0 hours post-irradiation is instantaneously >5.0 log and remains stable thereafter, reaching >5.2 log at 6 hours. Comparative Example 1 is the control group. At 6 hours, the kill log value is approximately 3.2 log. According to the "Disinfection Technical Specifications" (2002 edition) and GB / T 15979-2002 "Hygienic Standard for Disposable Sanitary Products", the disinfection compliance line is ≥3.0 log. This group has just reached the disinfection compliance line, and the disinfection rate is slow.

[0032] 2.2 Escherichia coli (Gram-negative bacteria): Example 1 is the NIR irradiation group. After 10 minutes of NIR irradiation, the kill log value at 0 hours post-irradiation is as high as >5.5 log, indicating complete sterility, and it remains stable thereafter. Comparative Example 1 is the control group. At 6 hours, the kill log value is about 3.5 log, which meets the disinfection standard but takes a very long time.

[0033] 2.3 Pseudomonas aeruginosa (a Gram-negative bacterium): Example 1 is the NIR irradiation group. After 10 minutes of NIR irradiation, the kill log value at 0 hours post-irradiation is >5.3 log, which means that complete killing has been achieved. Comparative Example 1 is the control group. At 6 hours, the kill log value is about 3.2 log, which means that disinfection has just been achieved and the time required is extremely long.

[0034] 2.4 Candida albicans (fungus): Example 1 is the NIR irradiation group. After 10 minutes of NIR irradiation, the kill log value at 0 hours post-irradiation is >4.5 log, and it continues to increase steadily thereafter, reaching >4.9 log at 6 hours. Comparative Example 1 is the control group. At 6 hours, the kill log value is approximately 2.8 log, meaning that effective fungal eradication has not been achieved even after 6 hours.

[0035] 2.5 Fusarium (a fungus belonging to the Solanaceae family): Example 1 is the NIR irradiation group. After 10 minutes of NIR irradiation, the kill log value at 0 hours post-irradiation is >4.2 log, and it continues to increase steadily thereafter, reaching >4.7 log at 6 hours. Comparative Example 1 is the control group. At 6 hours, the kill log value is only 2.5 log, meaning that effective fungal eradication has not been achieved even after 6 hours, indicating the worst killing effect against Fusarium moniliformes.

[0036] (3) Biosafety (cytotoxicity) test Test method: The MTT assay was used to test the cytotoxicity of the extract of the nursing solution in Example 1 after complete neutralization (after irradiation) on L929 mouse fibroblasts according to ISO10993-5 standard.

[0037] The above tests revealed a relative cell proliferation rate (RGR) of approximately 98% and a toxicity grade of 0 or 1, indicating good safety in the final product state. This demonstrates that the neutralized hydrogen peroxide solution for contact lenses proposed in this invention possesses excellent biocompatibility.

[0038] (4) Nanomaterial Residue Test Test method: Inductively coupled plasma mass spectrometry (ICP-MS) was used to detect the residual amounts of Yttrium (Y) and Titanium (Ti) elements on the surface of contact lenses after treatment and rinsing with the care solution in Example 1.

[0039] The above tests revealed that the residual amounts of the aforementioned elements were all below the detection limit (<1ppb), indicating that the core nanomaterials in the neutralized contact lens hydrogen peroxide care solution proposed in this invention are not easily adsorbed onto the lens, and can be avoided by rinsing.

[0040] (5) Eye irritation test Test Methods: In accordance with OECD Test Guideline 405 and relevant FDA guidelines, an in vitro bovine corneal turbidity and permeability test (BCOP) was conducted to evaluate the potential eye irritation of the contact lens solution after photoneutralization treatment. The contact lens solution prepared in Example 1 was subjected to 980nm NIR light (1W / cm²). 2 After irradiation for 10 minutes to allow complete neutralization, the sample was used as the test substance. A negative control group (physiological saline) and a positive control group (1% saponin solution) were also established. Freshly isolated bovine corneas were placed in a special clamp, with the corneal epithelial surface in contact with the test substance and incubated for 10 minutes. Afterward, corneal turbidity (OV) was measured using a turbidimeter, and the amount of sodium fluorescein permeable to the cornea (Permeability Value, PV) was determined using a spectrophotometer. The in vitro stimulation score (IVIS) was calculated using the following formula ①: IVIS = OV + 15 PV formula ①.

[0041] Through experiments and calculations, the following results were obtained: the IVIS of the experimental group (Example 1) was 2.8, the IVIS of the negative control group (physiological saline) was 0.5, and the IVIS of the positive control group (1% saponin) was 89.6. In the art, it is generally considered that: IVIS < 3 is non-irritating; 3 ≤ IVIS < 25 is mildly irritating; and IVIS ≥ 55 is severely irritating.

[0042] The above experiments revealed that the in vitro irritation score of the care solution in Example 1 after near-infrared light irradiation was far below the mild irritation threshold, and it was classified as non-irritating. This is consistent with and corroborates the extremely low cytotoxicity results in the biosafety (cytotoxicity) test. This fully demonstrates that the neutralized hydrogen peroxide care solution for contact lenses of the present invention is safe for eye tissues in the final use state.

[0043] (6) Compatibility test with contact lenses Test Methods: Compatibility tests were conducted according to ISO 11986:2012 standard and the general principles for the evaluation of compatibility of medical device materials. These tests verified that the neutralized hydrogen peroxide solution for contact lenses proposed in this invention does not negatively affect key parameters of common contact lens materials, ensuring both the care function and lens safety. Two commercially available lens materials, silicone hydrogel lenses and hydrogel lenses, were selected as test lenses. The test lenses were immersed in the unneutralized care solution from Example 1 at 25°C for 72 hours to simulate long-term contact. Simultaneously, another set of test lenses was immersed in PBS buffer, with other treatment conditions remaining unchanged, serving as a negative control. After immersion, the lenses were rinsed with plenty of purified water, and the contact angle, oxygen permeability coefficient (Dk value), material stability, and visible appearance of the lenses were measured.

[0044] Contact angle: The water contact angle of the lens surface was measured using the seated drop method to assess changes in wettability.

[0045] Oxygen permeability coefficient (Dk value): Measured using polarography.

[0046] Material stability: The intrinsic viscosity (η) is measured to analyze whether the lens material has undergone chemical degradation or change.

[0047] Specifically, one of the most direct manifestations of chemical degradation in polymer materials (such as main chain breakage and hydrolysis) is the decrease in their average molecular weight. Intrinsic viscosity η is a classic and sensitive physical quantity that indirectly characterizes the hydrodynamic volume and molecular weight of a polymer in solution. By accurately measuring the change in intrinsic viscosity of lens materials before and after immersion, it is possible to quantitatively assess whether the contact lens solution has induced polymer chain breakage. The measurement method is as follows: Lens materials that have been thoroughly rinsed and dried after immersion are used as a blank control, with un-immersed lens materials from the same batch. The intrinsic viscosity is measured using an Ubbelohde viscometer at the same standard solvent (N,N-dimethylformamide DMF) and temperature (25.0±0.1℃). By comparing the change in intrinsic viscosity before and after immersion, it is possible to quantitatively determine whether polymer chain breakage has occurred.

[0048] Results: The intrinsic viscosity of both silicone hydrogel and hydrogel lenses, after immersion in the solution from Example 1 for 72 hours, showed a change rate of less than 5% compared to the PBS negative control group and the unimmersed blank control group, which is within the range of instrument measurement error. In the evaluation of the aging and stability of polymeric materials, the rate of change of intrinsic viscosity η is a recognized indicator for measuring the degree of degradation. Numerous studies and industrial practices have shown that for precision medical polymeric products such as contact lenses, a change in intrinsic viscosity within ±5% is generally considered to be within the normal fluctuation range of the testing method, indicating that the material has not undergone statistically significant chemical degradation with functional impact. A change in intrinsic viscosity of less than 5% indicates that the material has not undergone significant chemical degradation or molecular weight change. This result provides direct and quantitative evidence that the solution did not cause damage to the chemical structure of the lens material.

[0049] Visible appearance: Observe the surface of the lens under an optical microscope for wear, deposits, or discoloration.

[0050] The test results of the above experiments are summarized in Table 1 below: Table 1. Compatibility test results of different contact lens solutions.

[0051] As shown in Table 1 above, after soaking in the solution of Example 1, there were no statistically significant differences (p>0.05) between the two types of contact lenses and the PBS control group in terms of wettability (contact angle), oxygen permeability (Dk value), chemical structure (change rate of intrinsic viscosity), and physical appearance. This demonstrates that the neutralized hydrogen peroxide solution for contact lenses proposed in this invention has good compatibility with contact lenses, will not damage the lenses or alter their key performance parameters, and the results of the nanomaterial residue test further verify the safety of this neutralized hydrogen peroxide solution for contact lenses.

[0052] The above experiments and their results demonstrate that the neutralizing hydrogen peroxide solution for contact lenses proposed in this invention, along with its preparation and usage methods, can significantly accelerate and enhance the disinfection and neutralization process through near-infrared light triggering, and its safety has been fully verified.

[0053] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A neutralizing hydrogen peroxide solution for contact lens care, characterized in that, It consists of the following components: 2.0-4.0% (w / v) hydrogen peroxide, 0.01-0.5% (w / v) poloxamer, 0.01-0.1% (w / v) diethylenetriaminepentamidephosphonic acid, 0.001-0.01% (w / v) UCNP@TiO2 nanomaterials, with the balance being a buffer system, osmotic pressure regulator, and purified water; Among them, UCNP@TiO2 nanomaterials are core-shell composite materials with lanthanide-doped upconversion nanomaterials as the core and titanium dioxide as the shell.

2. The neutralizing hydrogen peroxide solution for contact lenses according to claim 1, characterized in that, In UCNP@TiO2 nanomaterials, the core is a ytterbium-thulium-doped sodium fluorine upconversion nanomaterial.

3. The neutralizing hydrogen peroxide solution for contact lenses according to claim 2, characterized in that, The preparation method of UCNP@TiO2 nanomaterials includes the following steps: A1. Prepare yttrium nitrate mother liquor, ytterbium nitrate mother liquor, and thulium nitrate mother liquor separately; mix the yttrium nitrate mother liquor, ytterbium nitrate mother liquor, and thulium nitrate mother liquor, add a fluorine source and a complexing stabilizer, mix well, and then place in a sealed environment and heat to 160-220℃ for 6-24 hours; after the reaction is completed, cool, centrifuge, wash, and dry to obtain the upconversion nanomaterial core. A2 disperses the upconversion nanomaterial core in a solvent, adds a titanium source to carry out a hydrolysis reaction, coats the core surface with an amorphous titanium dioxide layer, centrifuges, washes, dries, and then calcines at high temperature to obtain UCNP@TiO2 nanomaterials.

4. The neutralizing hydrogen peroxide solution for contact lenses according to claim 3, characterized in that, In step A1, the fluorine source is sodium fluoride and / or ammonium fluoride.

5. The neutralizing hydrogen peroxide solution for contact lenses according to claim 3, characterized in that, In step A1, the complexing stabilizer is sodium citrate and / or EDTA.

6. A method for preparing a neutralizing hydrogen peroxide solution for contact lenses according to any one of claims 1 to 5, characterized in that, Includes the following steps: S1 Preparation of UCNP@TiO2 nanomaterial dispersion: First, take a portion of purified water, add UCNP@TiO2 nanomaterials, and disperse by ultrasonication to obtain a UCNP@TiO2 nanomaterial dispersion. S2 Preparation of Neutralized Hydrogen Peroxide Solution for Contact Lenses: Take the correct amounts of poloxamer, diethylenetriaminepentamethylphosphonic acid, buffer system, and osmotic pressure regulator, dissolve them in the remaining purified water, and stir until homogeneous. Then, under stirring conditions at 15-25℃, add hydrogen peroxide and stir until homogeneous. Finally, add the UCNP@TiO2 nanomaterial dispersion and mix until homogeneous to obtain the neutralized hydrogen peroxide contact lens care solution.

7. The neutralizing hydrogen peroxide solution for contact lenses according to claim 6, characterized in that, In step S1, based on the total volume of the neutralized contact lens hydrogen peroxide treatment solution, take 10-20% of purified water, add UCNP@TiO2 nanomaterials, and alternate between turning on the ultrasonicator for 2-3 seconds and turning it off for 1-2 seconds. The total ultrasonic treatment time is 10-20 minutes to obtain a UCNP@TiO2 nanomaterial dispersion.

8. The neutralizing hydrogen peroxide solution for contact lenses according to claim 6, characterized in that, In step S2, the buffer system includes anhydrous disodium hydrogen phosphate, and / or sodium dihydrogen phosphate monohydrate, and / or phosphoric acid. The buffer system is added to adjust the pH of the system to 6.5-7.

5.

9. The neutralizing hydrogen peroxide solution for contact lenses according to claim 6, characterized in that, In step S2, the osmotic pressure regulator is sodium chloride, and the osmotic pressure regulator is added to adjust the osmotic pressure of the system to 250-320 mOsm / kg.

10. A method of using the neutralizing hydrogen peroxide solution for contact lenses according to any one of claims 1 to 5, characterized in that, Immerse the contact lenses in a neutralized hydrogen peroxide solution and irradiate them with near-infrared light at a wavelength of 980±10nm for 1-15 minutes. Then remove the contact lenses, rinse them, and they are ready to be worn.

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