A method for removing protein and sterilizing a semi-annual replacement contact lens and a detection method

Abstract

The application discloses a protein removing and sterilizing method and a detection method for a semi-annual throwing hydrogel contact lens. ‑ The protein attached to the surface of the semi-annual throwing hydrogel contact lens is charged in the physiological saline, the charged protein moves to the electrode position opposite to the electric property, Cl ‑ The generated hypochlorous acid is oxidized with the protein in the protein removing and sterilizing tank, the protein is degraded, the hypochlorous acid inactivates the functional protein of the microorganism, and the microorganism is killed; the detection method calculates the elution rate of the protein on the semi-annual throwing hydrogel contact lens by detecting the protein content before and after lens cleaning. The protein removing and sterilizing method and the detection method effectively solve the problems that the corneal contact lens is difficult to restore and the cleaning effect is difficult to evaluate.

Description

Technical Field

[0001] This invention relates to the field of corneal contact lenses, and more particularly to a method for removing proteins and sterilizing six-month disposable hydrogel contact lenses, as well as a testing method. Background Technology

[0002] The problem of protein removal from contact lenses has plagued the industry for over half a century, prompting the optometry industry worldwide to place great emphasis on contact lens safety. This is because contact lens materials have numerous microscopic permeability pores. The human eye constantly secretes large amounts of tears, which contain significant amounts of tear proteins. These tear proteins easily penetrate these pores, reducing the lens's DK value (oxygen permeability) and causing symptoms such as corneal hypoxia and edema. In severe cases, this can lead to corneal damage, bacterial infection, corneal inflammation, and even vision impairment.

[0003] To ensure eye safety, several contact lens cleaners are available on the market for cleaning and restoring worn contact lenses. However, the effectiveness of these cleaners for different lens sizes and models has not been tested, posing a potential safety hazard. If the cleaner and cleaning solution have limitations in cleaning and restoring contact lenses, users may continue to use them even when the cleaner is unsuitable. Over time, this could lead to eye problems, which is irresponsible and disregards eye safety. Currently, various sizes and models of contact lenses are available. Six-month disposable hydrogel contact lenses offer cost savings compared to quarterly lenses, and are safer than annual lenses due to their shorter lifespan. Therefore, six-month disposable hydrogel contact lenses are a common eye care product. Therefore, effectively removing proteins from the surface of six-month disposable hydrogel contact lenses to ensure eye safety is a major health concern for users. Thus, it is necessary to propose a protein removal and sterilization method for six-month disposable hydrogel contact lenses to safeguard users' eye safety.

[0004] Currently, various methods for removing tear proteins from the surface of contact lenses have been introduced to the market. However, since it is not visible to the naked eye whether tear proteins have been completely and effectively washed away and degraded, protein detection methods and sterilization detection methods have gradually been developed to verify the cleaning effect of contact lenses after cleaning and restoration by a cleaning device and to ensure the safety of consumers' eyes. This allows for scientific testing to effectively verify whether proteins and bacteria have been completely degraded and killed. However, the current detection methods for effective protein removal from contact lenses on the market have limitations. It is not yet possible to find a method that can directly, effectively, and accurately measure the specific amount of tear proteins adsorbed by the contact lens. Therefore, the test results are not comprehensive and only have certain reference value. They cannot be used as a professional test basis for quantitative and qualitative detection of the degree of protein degradation. Therefore, it is necessary to propose a testing method for the protein removal and sterilization effect of six-month disposable hydrogel contact lenses. This testing method can be used to test the effectiveness of the proposed protein removal and sterilization method for six-month disposable hydrogel contact lenses, and the test results can serve as a guarantee for users. This protein removal and sterilization method can guide users to properly clean and sterilize six-month disposable hydrogel contact lenses, thereby reducing the rate of eye infection and ensuring the safety of users' eyes.

[0005] Therefore, there is an urgent need to propose a new technical solution to address the above problems. Summary of the Invention

[0006] One objective of this invention is to provide a protein removal and sterilization method for six-month disposable hydrogel contact lenses. This method can remove proteins, bacteria, and lipids adsorbed on the surface and within the oxygen pores of the six-month disposable hydrogel contact lenses, achieving a complete restoration of the lenses. This provides consumers with an effective cleaning method for six-month disposable hydrogel contact lenses, ensuring lens safety when in contact with the eyes. Another objective of this invention is to provide a protein removal and sterilization testing method for six-month disposable hydrogel contact lenses. This method can effectively verify the restoration effect of the protein removal and sterilization method described in this invention on six-month disposable hydrogel contact lenses. This testing method detects bacteria, proteins, and lipids that are invisible to the naked eye, providing consumers with test results through chemical experiments. This demonstrates that the protein removal and sterilization method described in this invention can clean and restore six-month disposable hydrogel contact lenses, scientifically ensuring that lenses cleaned by the cleaner are safe and harmless, further protecting users' eye safety.

[0007] On the one hand, the present invention provides a method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens, the technical solution of which is as follows:

[0008] A method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens, comprising: detecting the elution rate of protein on the six-month disposable hydrogel contact lens after protein removal and sterilization, specifically including:

[0009] The protein content adsorbed on the surface of a six-month disposable hydrogel soft hydrophilic contact lens was detected to obtain the original protein content of the lens. The six-month disposable hydrogel soft hydrophilic contact lens was then placed in a protein removal sterilizer with physiological saline for protein removal sterilization treatment. The protein content of the six-month disposable hydrogel soft hydrophilic contact lens after treatment with the protein removal sterilizer was detected to obtain the remaining protein content of the lens after cleaning. The remaining protein content of the lens after cleaning was calculated and analyzed with the original protein content of the lens to obtain the elution rate of proteins adsorbed on the surface and in the oxygen permeable pores of the six-month disposable hydrogel soft hydrophilic contact lens by the protein removal sterilizer with physiological saline.

[0010] Furthermore, the above technical solution involves placing the six-month disposable hydrogel soft hydrophilic contact lens in a protein removal sterilizer and using physiological saline for protein removal sterilization treatment, specifically including:

[0011] Select the cleaning mode of the protein removal sterilizer, place the six-month disposable hydrogel soft hydrophilic contact lens in the protein removal sterilizer's protein removal sterilization tank and clean it with physiological saline for a predetermined time to obtain the six-month disposable hydrogel soft hydrophilic contact lens after protein removal sterilization treatment.

[0012] Furthermore, the protein content of the six-month disposable hydrogel soft hydrophilic contact lenses treated with the aforementioned protein removal sterilizer was detected to obtain the amount of residual protein in the lenses after cleaning, specifically including:

[0013] The six-month disposable hydrogel soft hydrophilic contact lens, which has been treated by the protein removal sterilizer, is placed in a protein extraction solution, and the protein is extracted by vibration. The protein concentration in the protein extraction solution is detected by a micro-ultraviolet spectrophotometer, and the amount of remaining protein in the lens after cleaning is calculated from the protein concentration value.

[0014] Furthermore, the predetermined time is 3 minutes. During the process of cleaning the semi-annual disposable hydrogel soft hydrophilic contact lens using the protein removal sterilizer, the voltage difference between the two electrophoretic dissociation probes in the protein removal sterilizer tank is 0.55V-4.8V, and the current value is 0.45-4.5mA.

[0015] Furthermore, the protein extract is composed of 50 parts acetonitrile, 50 parts deionized water and 0.2 parts 100% trifluoroacetic acid.

[0016] Furthermore, the amount of residual protein on the cleaned lens and the amount of original protein on the lens are calculated and analyzed to obtain the elution rate of proteins adsorbed on the surface and inside the oxygen-permeable pores of the six-month disposable hydrogel soft hydrophilic contact lens using a protein removal sterilizer and physiological saline:

[0017] .

[0018] Furthermore, the above technical solution also includes: testing the sterilization effect of the six-month disposable hydrogel contact lens after protein removal and sterilization using the above-mentioned protein removal and sterilization method, specifically including:

[0019] Physiological saline was added to the protein removal sterilization tank of the protein removal sterilizer. The protein removal sterilizer was started, and after a predetermined time, sterilization-generating water stock solution was obtained from the protein removal sterilization tank. A neutralizing agent and bacterial suspension for sterilization detection experiments were selected. The bacterial suspension and organic interfering substances were mixed at a weight ratio of 1:1 and placed in a water bath. After a predetermined time, the obtained sterilization-generating water stock solution was added to obtain a mixture. After a predetermined reaction time, the mixture was mixed with the neutralizing agent at a weight ratio of 1:9, diluted, inoculated, and viable bacteria were cultured and counted. The logarithmic killing value of the sterilization-generating water stock solution on the bacteria in the bacterial suspension was detected.

[0020] Furthermore, it also includes: testing the surface grease removal effect of six-month-old disposable hydrogel contact lenses sterilized using the aforementioned protein removal and sterilization method, specifically including:

[0021] The oil content on the surface of a six-month disposable hydrogel contact lens with adsorbed oil was detected.

[0022] Physiological saline was added to the protein removal sterilization tank of the protein removal sterilizer. The six-month disposable hydrogel contact lens with grease adsorbed on its surface was placed in the physiological saline. The protein removal sterilizer was started. After cleaning, the grease content on the surface of the six-month disposable hydrogel contact lens cleaned by the protein removal sterilizer was measured, and the grease removal rate of the six-month disposable hydrogel contact lens by the protein removal sterilizer and physiological saline was measured.

[0023] Furthermore, a light beam is emitted to the semi-annual disposable hydrogel contact lens with grease adsorbed on its surface using a fluorescence spectrophotometer, and the fluorescence intensity value of the emission spectrum is recorded. The fluorescence intensity value corresponds to the grease content on the surface of the semi-annual disposable hydrogel contact lens.

[0024] .

[0025] On the other hand, the present invention also provides a method for removing proteins and sterilizing semi-annual disposable hydrogel contact lenses, the technical solution of which is as follows:

[0026] A method for protein removal and sterilization of a six-month disposable hydrogel contact lens includes: providing a protein removal sterilizer, the sterilizer having a protein removal sterilization tank, wherein at least two electrophoretic dissociation probes are disposed in the protein removal sterilization tank; adding physiological saline and a six-month disposable hydrogel contact lens into the protein removal sterilization tank; activating the protein removal sterilizer; energizing the two electrophoretic dissociation probes, one of which is a positive electrode and the other a negative electrode; proteins adhering to the surface of the six-month disposable hydrogel contact lens becoming charged in the physiological saline, and the charged proteins moving towards the electrode position with the opposite charge; and the Cl in the physiological saline... - The protein moves toward the positive electrode, loses electrons, and is oxidized into chlorine gas. The chlorine gas dissolves in the physiological saline to generate hypochlorous acid. The hypochlorous acid reacts with the protein in the protein removal sterilization tank in a redox reaction, and the protein is degraded. The hypochlorous acid also undergoes its own redox reaction in the physiological saline, decomposing into hydrogen ions, chloride ions, and oxygen. During the decomposition process, the hypochlorous acid absorbs electrons from the functional proteins of the microorganisms in the protein removal sterilization tank, thereby inactivating the functional proteins of the microorganisms and killing them.

[0027] Furthermore, the above technical solution also includes: positively charged hydrogen ions in the saline solution move towards the negative electrode and undergo a reduction reaction near the negative electrode to generate hydrogen gas; sodium ions in the saline solution react with hydroxide ions to generate sodium hydroxide; and the grease on the surface of the six-month disposable hydrogel contact lens undergoes a saponification reaction with the sodium hydroxide, thereby removing the grease from the surface of the six-month disposable hydrogel contact lens.

[0028] Furthermore, the hypochlorous acid reacts with the protein in a protein-removing sterilization tank via a redox reaction, resulting in protein degradation. Specifically, this includes:

[0029] The hypochlorous acid reacts with the peptide chains that form the protein backbone to yield chloral-formamide. The peptide chains formed by chloral-formamide are then hydrolyzed in solution, resulting in the breakage of peptide bonds and decomposition into small protein molecules and amino acids. This protein degradation, and / or...

[0030] The hypochlorous acid reacts with the side chains of the peptide chains that form the protein backbone, the side chains including lysine side chains. The hypochlorous acid reacts with the lysine side chains to form chloramine on the lysine side chains and the amino groups of the protein. The chloramine decomposes to form organic molecular fragments in the form of carbonyl groups [1,2]. The peptide bonds on the lysine side chains break, decomposing into small molecule proteins and amino acids, and the protein is degraded.

[0031] Furthermore, the microorganisms include bacteria and viruses. During the decomposition process, the hypochlorous acid absorbs electrons from the functional proteins on the cell walls of the bacteria, thus inactivating the bacteria. During the decomposition process, the hypochlorous acid absorbs electrons from the functional proteins on the outer shell of the virus, thus inactivating the virus. The hypochlorous acid has strong oxidizing properties and penetrates into the microbial cells, reacting with the bacterial proteins, nucleic acids, and enzymes within the microbial cells to kill the microorganisms.

[0032] Compared with the prior art, the present invention has one or more of the following beneficial effects:

[0033] 1. This invention provides a method for protein removal and sterilization of six-month disposable hydrogel contact lenses. This method utilizes a protein removal sterilizer in conjunction with physiological saline to achieve electrophoretic dissociation and protein removal sterilization (physiological saline itself does not have a sterilizing effect). Two electrophoretic dissociation probes are positioned opposite each other in the protein removal sterilization tank of the sterilizer. When the sterilizer is energized, these two probes can transform into a positive electrode and a negative electrode, forming the basis for protein electrophoresis. Furthermore, the interaction between the two electrodes and physiological saline generates hypochlorous acid, a highly oxidizing agent. Hypochlorous acid can degrade proteins and also sterilize. Additionally, sodium hydroxide generated from sodium ions and hydroxide ions in the physiological saline can remove grease. Therefore, the protein removal and sterilization method described in this invention can effectively remove proteins and sterilize six-month disposable hydrogel contact lenses.

[0034] 2. This invention provides a protein removal and sterilization method for a six-month disposable hydrogel contact lens. It combines the principle of protein electrophoresis with electrolysis technology to obtain a novel electrophoretic dissociation protein removal and sterilization technique. This technique, combined with physiological saline (containing chloride ions), generates hypochlorous acid in the protein removal and sterilization tank. Hypochlorous acid, as a strong oxidant, can absorb electrons from the surface proteins of bacterial cell walls, thereby oxidizing the functional proteins on the bacterial surface. The bacteria eventually become inactive due to their inability to absorb nutrients, metabolize normally, and stop dividing, ultimately achieving sterilization and disinfection. Hypochlorous acid, as a strong oxidant, can also absorb electrons from the surface proteins on the outer shell of viruses, causing viral inactivation. Hypochlorous acid not only acts on the surface of microorganisms but can also penetrate into microbial cells, reacting with the bacterial (viral) proteins, nucleic acids, enzymes, and other organic macromolecules within the microbial cells to kill pathogenic microorganisms. Therefore, the protein removal and sterilization method described in this invention has the dual effects of protein removal and sterilization.

[0035] 3. Long-term use of six-month disposable hydrogel contact lenses will result in protein deposits in the cleaning tank. The protein removal and sterilization method described in this invention utilizes the property of hypochlorous acid to degrade tear proteins. The hypochlorous acid reacts with the deposited proteins through oxidation, which decomposes these stubborn deposited proteins into small molecule proteins and amino acids. Small molecule proteins are more easily adsorbed than deposited proteins. Therefore, the protein removal and sterilization method described in this invention can effectively remove the deposited proteins on six-month disposable hydrogel contact lenses.

[0036] 4. This invention utilizes hypochlorous acid to degrade proteins, which involves two methods: First, direct degradation of the protein's backbone peptide chain. This degradation occurs through the reaction of hypochlorous acid with the peptide backbone to form chloral-formamide. The chloral-formamide backbone is easily hydrolyzed in aqueous solution, leading to peptide bond breakage and protein degradation. Second, degradation of the side chains on the peptide backbone via hypochlorous acid. The side chains are arranged according to their reactivity with hypochlorous acid, in the order of methionine > cysteine ​​> histidine > α-amino acid > tryptophan > lysine > tyrosine > arginine > glutamic acid. Unstable chloramines are formed on the amino and lysine side chains, eventually decomposing into carbonyl organic molecular fragments [1,2]. Both degradation methods break down tear proteins into smaller protein molecules, aiding in electrophoretic adsorption and resulting in more thorough protein removal. Of course, due to the diversity of protein molecules, there are other ways to degrade proteins using hypochlorous acid besides these two methods. This invention only provides these two relatively effective degradation methods. Therefore, the protein removal method proposed in this invention can effectively remove proteins adsorbed on the surface and within the oxygen-permeable pores of a six-month disposable contact lens.

[0037] 5. The protein removal and sterilization method for a six-month disposable hydrogel contact lens provided by this invention achieves the effect of protein removal and sterilization through the combined action of a protein removal sterilizer and physiological saline. This method discloses the principle of protein removal and sterilization in depth through electrophoretic dissociation technology and interprets the effectiveness of the method from a biochemical perspective.

[0038] 6. This invention also provides a method for detecting protein removal and sterilization in six-month disposable hydrogel contact lenses. This method calculates the protein elution rate of the six-month disposable hydrogel contact lens using the protein removal and sterilization method described in this invention by detecting the content of proteins adsorbed on the surface and in the oxygen permeability pores of the lens before and after cleaning. The detection of the protein content adsorbed on the surface and in the oxygen permeability pores before and after cleaning is performed by vibration extraction using the protein extraction solution described in this invention. In the prior art, it is difficult to measure the specific content of tear proteins adsorbed by corneal contact lenses. However, this invention achieves protein extraction using a protein extraction solution composed of acetonitrile-pure water-trifluoroacetic acid mixed solution. The protein content in the protein extraction solution is then detected using an ultraviolet spectrophotometer, thereby determining the specific content of tear proteins adsorbed by the corneal contact lens. The protein separation solution described in this invention does not react with the corneal contact lens material and does not affect the protein measurement value. Corneal contact lenses cultured with artificial tears are used as test samples, placed in the protein separation solution for vibration extraction to separate proteins, and the protein elution rate of the protein separation solution is calculated.

[0039] 7. This invention also provides a method for detecting the sterilization effect of a protein removal sterilizer on a six-month disposable hydrogel contact lens. This method can detect the sterilization effect of a protein removal sterilizer combined with physiological saline on the six-month disposable hydrogel contact lens. To avoid contaminating the protein removal sterilizer, bacteria are not directly inoculated into it. The detection method involves adding physiological saline to the protein removal sterilization tank of the protein removal sterilizer, starting the sterilizer, and after a predetermined time, obtaining a sterilization-generating solution from the tank. The obtained sterilization-generating solution is then used for sterilization testing, and the logarithmic kill value of the sterilization-generating solution on the bacterial suspension is detected. It should be noted that the sterilization effect using the sterilization-generating solution is actually inferior to that using the protein removal sterilizer. When using a protein removal sterilizer combined with physiological saline, the sterilization solution in the sterilization tank is also subjected to electrophoretic dissociation by an electric current. Therefore, the sterilization effect using the protein removal sterilizer is actually superior to that using the sterilization-generating solution.

[0040] 8. The present invention also provides a method for detecting protein removal and sterilization of six-month disposable hydrogel contact lenses. The detection method of the present invention uses a fluorescence spectrophotometer to emit a light beam to the six-month disposable hydrogel contact lens with grease adsorbed on its surface, and records the fluorescence intensity value of the emitted spectrum to obtain the grease adhesion on the lens before and after cleaning. Then, by calculation and analysis, the effect of the protein removal sterilizer combined with physiological saline on the removal of grease on the surface of the six-month disposable hydrogel contact lens can be detected. Detailed Implementation

[0041] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0042] In the description of this invention, it should be understood that, unless otherwise expressly specified and limited, the terminology should be interpreted broadly, and those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0043] The essence of the present invention will be further illustrated below with reference to the embodiments.

[0044] Example 1:

[0045] Contact lenses were classified as Class III medical devices in 2012, and are subject to high-risk management. Cleaning solutions used with contact lenses are also classified as Class III medical devices. Cases of corneal infections caused by contact lenses are frequent, and even the best-selling six-month disposable hydrogel contact lenses pose a risk of corneal infection if not properly cleaned. Therefore, the issue of cleaning and restoring six-month disposable hydrogel contact lenses has become a focus of public attention. This invention focuses on providing a protein removal and sterilization method for six-month disposable hydrogel contact lenses. It utilizes electrophoretic dissociation technology to clean and restore the lenses, ensuring effective cleaning after use and guaranteeing safety for the eyes.

[0046] This invention provides a method for protein removal and sterilization of a six-month disposable hydrogel contact lens, comprising: providing a protein removal sterilizer, the protein removal sterilizer having a protein removal sterilization tank, the protein removal sterilization tank being provided with at least two electrophoretic dissociation probes, adding physiological saline to the protein removal sterilization tank, placing the six-month disposable hydrogel contact lens in the physiological saline, and activating the protein removal sterilizer, wherein...

[0047] The two electrophoretic dissociation probes form a positive electrode and a negative electrode after energization. Proteins attached to the surface of the semi-permanent hydrogel contact lens become charged in the physiological saline. The charged proteins migrate towards the electrode with the opposite charge (i.e., protein electrophoresis). The Cl in the physiological saline... -The protein moves towards the positive electrode, loses electrons, and is oxidized into chlorine gas. This chlorine gas dissolves in the physiological saline to generate hypochlorous acid (i.e., electrolysis). The hypochlorous acid reacts with the protein in the protein removal sterilization tank via a redox reaction, degrading the protein. This is the working principle of protein removal using electrophoretic dissociation technology. The electrophoretic dissociation probe described in this invention is a nanoscale coated material electrophoretic dissociation probe. Under the combined action of the protein removal sterilizer and physiological saline (or electrolyte solution), this probe promotes electrophoresis and dissociation reactions in the protein removal sterilization tank.

[0048] Further explanation of the principle of protein removal by electrophoresis as described in this invention:

[0049] This invention utilizes an electrophoretic dissociation method for protein sterilization, primarily combining protein electrophoresis and electrolysis techniques. First, protein electrophoresis refers to the movement of charged particles or molecules in an electric field. Large molecules such as proteins, polypeptides, viral particles, and even cells, or small molecules like amino acids and nucleosides, can undergo directional migration in an electric field. In the contact lens cleaner described in this invention, the charged tear proteins move towards the probe electrode position under the influence of the probe field strength within the cleaning chamber, thus achieving the effect of cleaning the corneal contact lens. Second, electrolysis refers to the process of inducing redox reactions at the cathode and anode after an electric current is passed through an electrolyte solution or molten electrolyte (also known as an electrolyte solution).

[0050] In one embodiment, the present invention uses physiological saline as the electrolyte solution for cleaning lenses. During electrolysis, chloride ions in the physiological saline move towards the positive electrode probe, lose electrons, and are reduced to chlorine gas. A portion of the chlorine gas generated from the physiological saline of a certain concentration is expelled through bubbles, while the remainder dissolves in water and undergoes the following chemical reaction:

[0051] Cl₂ + H₂O = HCl + HClO

[0052] The HClO produced by this reaction has the effect of degrading proteins and sterilizing.

[0053] The above theory proves that the electrolyte solution used in the electrophoretic dissociation protein removal and sterilization method of this invention can be any chloride-containing solution that does not contain heavy metals, even ordinary contact lens solutions (basically all commercially available contact lens solutions contain chloride ions). Common examples include NaCl solution, KCl solution, MgCl2 solution, and Cl-containing eyeglass care solutions, or combinations of these solutions (provided that no reaction occurs that would disrupt electrolysis and prevent the formation of hypochlorous acid in the lens cleaning tank). Therefore, in the electrophoretic dissociation protein removal and sterilization method of this invention, any available chloride-containing solution can achieve the dual effects of protein removal and sterilization.

[0054] In one embodiment, the hypochlorous acid of the present invention undergoes a redox reaction with the protein in a protein removal sterilization tank, and the protein is degraded by reacting the hypochlorous acid with the peptide chain that forms the protein backbone to obtain chloral aldehyde formamide. The peptide chain formed by chloral aldehyde formamide is hydrolyzed in solution, and the peptide bonds in the peptide chain break, decomposing into small molecule proteins and amino acids, thus degrading the protein.

[0055] In another embodiment, the hypochlorous acid of the present invention undergoes a redox reaction with the protein in a protein sterilization tank, and the protein is degraded by the reaction of the hypochlorous acid with the side chains of the peptide chains that form the protein backbone, the side chains including lysine side chains. The hypochlorous acid reacts with the lysine side chains to form chloramine on the lysine side chains and the amino groups of the protein. The chloramine decomposes to form organic molecular fragments in the form of carbonyl groups [1,2]. The peptide bonds on the lysine side chains break, decomposing into small molecule proteins and amino acids, thus degrading the protein.

[0056] In another embodiment, the hypochlorous acid of the present invention undergoes an oxidation-reduction reaction with the protein in a protein removal sterilization tank, and the protein is degraded by the reaction of the hypochlorous acid with the peptide chains that form the protein backbone and the side chains of the peptide chains that form the protein backbone.

[0057] Physiological saline itself does not have a bactericidal effect. However, the protein removal sterilization method described in this invention, using a protein removal sterilizer in conjunction with physiological saline, generates hypochlorous acid, which has bactericidal properties. Hypochlorous acid undergoes a self-redox reaction in the physiological saline, decomposing into hydrogen ions, chloride ions, and oxygen. During this decomposition process, it absorbs electrons from the functional proteins of microorganisms in the protein removal sterilization tank, thereby inactivating the functional proteins and killing the microorganisms. This is the principle of sterilization using the strong oxidizing properties of hypochlorous acid. In one embodiment, the microorganisms attached to the contact lens include bacteria and viruses. During the decomposition process, hypochlorous acid absorbs electrons from the functional proteins on the cell walls of bacteria, inactivating the bacteria; it also absorbs electrons from the functional proteins on the outer shell of viruses, inactivating the viruses. Hypochlorous acid, with its strong oxidizing properties, penetrates the microbial cells and reacts with the bacterial proteins, nucleic acids, and enzymes within the microbial cells, thus killing the microorganisms. These sterilization methods all utilize the strong oxidizing properties of hypochlorous acid.

[0058] In the above technical solution, when the protein removal sterilizer is activated, positively charged hydrogen ions in the physiological saline move towards the negative electrode and undergo a reduction reaction near the negative electrode to generate hydrogen gas. Sodium ions in the physiological saline react with hydroxide ions to form sodium hydroxide. The grease on the surface of the six-month disposable hydrogel contact lens undergoes a saponification reaction with the sodium hydroxide, and the grease on the surface of the six-month disposable hydrogel contact lens is hydrolyzed. This is the lipid removal effect brought about by the protein removal sterilization method of the present invention. The protein removal sterilization process also promotes the change of solution pH. When lipids are attached to the lens, electrophoretic dissociation promotes the saponification reaction. Therefore, when there is lipid on the surface of the six-month disposable contact lens, the electrophoretic dissociation protein removal sterilization method of the present invention can remove lipids incidentally.

[0059] Existing six-month disposable hydrogel contact lenses are very inefficient to clean daily by hand rubbing or soaking in cleaning solutions, achieving less than 10% protein removal. Furthermore, since the main component of these lenses is hydroxyethyl methacrylate, a colloidal material, rubbing them with fingers can easily scratch and damage the lenses, reducing their lifespan. The protein removal and sterilization method described in this invention uses electrophoretic dissociation technology for safe and efficient protein removal and sterilization. When oil adheres to the lens surface, it also removes lipids, offering multiple benefits: highly efficient cleaning and rapid restoration.

[0060] Example 2:

[0061] To test the cleaning effect of the protein removal sterilization method described in this invention on six-month disposable hydrogel contact lenses, this invention also proposes a protein removal sterilization testing method for six-month disposable hydrogel contact lenses, which includes: testing the elution rate of proteins adsorbed on the surface and oxygen permeable pores of the six-month disposable hydrogel contact lens by a protein removal sterilizer combined with physiological saline, specifically including:

[0062] The content of proteins adsorbed on the surface of a six-month disposable hydrogel soft hydrophilic contact lens was detected to obtain the original protein content of the lens.

[0063] The six-month disposable hydrogel soft hydrophilic contact lens was placed in a protein removal sterilizer and sterilized with physiological saline. The six-month disposable hydrogel soft hydrophilic contact lens was placed in the protein removal sterilizer and cleaned with physiological saline for 3 minutes. During the cleaning process, the voltage difference between the two electrophoretic dissociation probes in the protein removal sterilizer was 0.55V-4.8V, and the current was 0.45-4.5mA.

[0064] The protein content of the six-month disposable hydrogel soft hydrophilic contact lens after being treated by the protein removal sterilizer was detected to obtain the amount of residual protein in the lens after cleaning: The six-month disposable hydrogel soft hydrophilic contact lens treated by the protein removal sterilizer was placed in a protein extraction solution, and the protein was extracted by vibration. The protein concentration value in the protein extraction solution was detected by a micro-ultraviolet spectrophotometer, and the amount of residual protein in the lens after cleaning was calculated from the protein concentration value.

[0065] The amount of residual protein on the cleaned lens was calculated and analyzed in conjunction with the amount of original protein on the lens to obtain the elution rate of proteins adsorbed on the surface and within the oxygen-permeable pores of a six-month disposable hydrogel soft hydrophilic contact lens using a protein removal sterilizer and physiological saline.

[0066] .

[0067] In one embodiment, the protein extraction solution is composed of 50 parts acetonitrile, 50 parts deionized water, and 0.2 parts 100% trifluoroacetic acid. The main principle behind the above detection method is that tear proteins adsorbed on the surface and internal oxygen permeability pores of the corneal contact lens can be 100% extracted using a mixed solution of acetonitrile-trifluoroacetic acid-water. This protein extraction solution does not react with the corneal contact lens material and does not affect the protein measurement value. Therefore, the corneal contact lens used as the test sample can be placed in the protein extraction solution for vibration extraction and protein separation. The protein concentration in the protein extraction solution is then detected using a micro-ultraviolet spectrophotometer. The protein content adsorbed by the lens can be obtained by simple calculation of this protein concentration.

[0068] It should be noted that the currently known substance for extracting proteins is PBS solution (phosphate buffer solution, a standard salt solution), but it also has limitations, namely, it cannot fully extract proteins from contact lenses. Therefore, there is currently no universally accepted method to test the actual protein content adsorbed on contact lenses worn by the human eye. However, to demonstrate the effectiveness of the method described in this invention, experiments were conducted using contact lenses cultured in artificial tears. Given the lack of a specific method to measure the actual protein content adsorbed on contact lenses, this experiment assumes that the actual protein content adsorbed on contact lenses cultured in artificial tears is the theoretical protein content calculated from the lens adsorption.

[0069] The experimental steps to verify the above statement are as follows:

[0070] 1. The protein extract was prepared by mixing 50 parts acetonitrile, 50 parts deionized water and 0.2 parts 100% trifluoroacetic acid;

[0071] 2. Take FDA-classified Class IV soft hydrophilic contact lenses and incubate them at 37°C for one day in a centrifuge tube containing 1 ml of artificial tears (2.2 mg / ml). After removing the lenses, the protein concentration in the centrifuge tube was measured to be 1.328 mg / ml. The theoretical value of the protein content adsorbed by the lenses is 2.2 - 1.328 = 0.872 mg.

[0072] 3. Take 1 ml or 4 ml of the protein extraction solution to fully dissolve the lens cultured with artificial tears in step 2, and shake it at room temperature for 24 hours. After shaking extraction, the measured protein concentration is 0.805 mg / ml. Therefore, the protein extraction rate using the protein extraction solution is calculated to be 0.805 / 0.872*100%=92.3%.

[0073] The protein extraction capability of the protein extraction solution described in this invention has been verified through the above experiments. Therefore, the protein extraction solution described in this invention can be used to perform experiments on protein concentration extraction and detection.

[0074] Example 3:

[0075] An experiment was conducted using the detection method described in Example 2 to determine the elution rate of proteins adsorbed on the surface and within the oxygen-permeable pores of a six-month disposable hydrogel contact lens using a protein removal sterilizer and physiological saline. The experimental steps are as follows:

[0076] 1. Wearing CooperVision Essilor™ High Oxygen Permeability Semi-Disposable Lenses (National Medical Device Registration No. 20173226973, LOT: 453850619120) for 8 hours, lens material: Polymacon, water content: 38%;

[0077] 2. After wearing the glasses for 8 hours, remove the left and right lenses and place them into 1.5ml centrifuge tubes respectively. Add 1ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tubes and shake for 30 minutes. Then test the amount of lysozyme in the centrifuge tubes. The values ​​are 0.235mg and 0.237mg respectively. The average amount of protein adsorbed by the lenses after 1 day (8h) of wear is 0.236mg, which means that the original amount of protein in the lenses is 0.236mg.

[0078] 3. Repeat step 1. Wear the same person’s CooperVision Essilor™ high oxygen permeability six-month disposable (National Medical Device Registration No. 20173226973, LOT: 453850619120) hydrogel soft hydrophilic contact lens for 8 hours to obtain two corneal contact lenses with protein on the surface.

[0079] 4. Take one of the corneal contact lenses from step 3 and soak it in 1 ml of 0.9% physiological saline for 3 minutes. Then put it into a 1.5 ml centrifuge tube and add 1 ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tube. After shaking for 30 minutes, test the amount of lysozyme in the centrifuge tube. It is 0.232 mg.

[0080] 5. Take the other contact lens from step 3 and place it in the protein removal sterilization tank of the protein removal sterilizer. Add 1 ml of 0.9% physiological saline and start the protein removal sterilizer to clean for 3 minutes. During cleaning, measure the voltage across the probe at 4.45V and the current at 4.15mA (the voltage across the probe can be 0.55V-4.8V and the current can be 0.45-4.5mA). After cleaning, place the contact lens into a 1.5 ml centrifuge tube and add 1 ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tube. After shaking for 30 minutes, test the amount of lysozyme in the centrifuge tube. The result is 0.035 mg.

[0081] 6. Calculate the elution rate of proteins adsorbed on the surface and inside the oxygen-permeable pores of a 2-month disposable hydrogel contact lens using a protein removal sterilizer in conjunction with physiological saline:

[0082]

[0083] =(1-0.035mg / 0.236mg) *100% =85.2%;

[0084] Similarly, the protein elution rate of a disposable hydrogel contact lens soaked in physiological saline for six months is calculated to be (1-0.232mg / 0.236mg)*100%=1.7%.

[0085] Based on the above experimental results, it can be found that the protein removal sterilizer combined with physiological saline can achieve a protein elution rate of 85.2% for CooperVision Essilor™ high oxygen permeability six-month disposable hydrogel contact lenses, while the protein elution rate achieved by soaking CooperVision Essilor™ high oxygen permeability six-month disposable hydrogel contact lenses in physiological saline is only 1.7%. Therefore, the protein removal sterilizer combined with physiological saline can achieve a highly efficient cleaning and restoration effect for CooperVision Essilor™ high oxygen permeability six-month disposable hydrogel contact lenses.

[0086] It should be noted that in the experimental process described in the embodiments of the present invention, the protein is extracted by vibration using an acetonitrile-trifluoroacetic acid solution, which can detach the protein attached to the lens from the lens, that is, the protein dissolves in the protein extraction solution. Then, the absorbance value of the protein extraction solution is detected by a micro-ultraviolet spectrophotometer, and the protein content is calculated according to the protein concentration detection standard curve.

[0087] The protein concentration detection standard curve needs to be established manually. Establishing the protein concentration detection standard curve specifically includes:

[0088] Prepare a 4 mg / ml protein solution, serially dilute the protein solution, and test the absorbance and protein concentration of the protein solution multiple times. Record the average absorbance and the average protein concentration obtained from the test, as shown in Table 3-1 below. Construct a standard curve based on the average absorbance and the average protein concentration. If the linear deviation exceeds ±10%, the standard curve is considered invalid and needs to be repeated.

[0089] The functional expression for the protein concentration detection standard curve is:

[0090] y = 2.64033436x - 0.001002579,

[0091] Where y represents the measured protein concentration value, and x represents the absorbance value of the protein at 280 nm; curve fitting is performed based on the actual experimental data, and the degree of agreement between the experimental data and the fitting function is evaluated by a quantity R² related to the correlation coefficient. The closer the R² value is to 1, the higher the degree of agreement, and the closer it is to 0, the lower the degree of agreement. In one case, R² = 0.999999835 was calculated.

[0092] Table 3-1 Serial Dilution Table of Protein Solutions

[0093]

[0094] Example 4:

[0095] An experiment was conducted using the detection method described in Example 2 to determine the elution rate of proteins adsorbed on the surface and within the oxygen-permeable pores of a six-month disposable hydrogel contact lens using a protein removal sterilizer and physiological saline. The experimental steps are as follows:

[0096] 1. The human eye wears Haichang Clear Easy (National Medical Device Registration Certificate 20153221008, LOT: JMA025021) 6-month disposable hydrogel contact lenses for 8 hours. Lens material: polymerized from HEMA, EGDMA, D1173, MRA and coloring agents, water content: 38%;

[0097] 2. After wearing the glasses for 8 hours, remove the left and right lenses and place them into 1.5ml centrifuge tubes respectively. Add 1ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tubes and shake for 30 minutes. Then test the amount of lysozyme in the centrifuge tubes. The values ​​are 0.244mg and 0.249mg respectively. The average amount of protein adsorbed by the lenses after 1 day (8h) of wear is 0.246mg, which means that the original amount of protein in the lenses is 0.246mg.

[0098] 3. Repeat step 1, and wear Haichang Clear Easy (National Medical Device Registration Certificate 20153221008, LOT: JMA025021) six-month disposable hydrogel contact lenses for 8 hours to obtain two corneal contact lenses with protein on the surface;

[0099] 4. Take one of the corneal contact lenses from step 3 and soak it in 1 ml of 0.9% physiological saline for 3 minutes. Then put it into a 1.5 ml centrifuge tube and add 1 ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tube. After shaking for 30 minutes, test the amount of lysozyme in the centrifuge tube. It is 0.241 mg.

[0100] 5. Take the other contact lens from step 3 and place it in the protein removal sterilization tank of the protein removal sterilizer. Add 1 ml of 0.9% physiological saline and start the protein removal sterilizer to clean for 3 minutes. During cleaning, measure the voltage across the probe, which should be 4.68V and the current, which should be 4.27mA (the voltage across the probe can be 0.55V-4.8V and the current can be 0.45-4.5mA). After cleaning, place the contact lens in a 1.5ml centrifuge tube and add 1 ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tube. After shaking for 30 minutes, test the amount of lysozyme in the centrifuge tube. The result should be 0.028mg.

[0101] 6. Calculate the elution rate of proteins adsorbed on the surface and inside the oxygen-permeable pores of a 2-month disposable hydrogel contact lens using a protein removal sterilizer in conjunction with physiological saline:

[0102]

[0103] =(1-0.028mg / 0.246 mg) *100% =88.6%;

[0104] Similarly, the protein elution rate of a disposable hydrogel contact lens soaked in physiological saline for six months is calculated to be (1-0.241mg / 0.246mg)*100%=2%.

[0105] Based on the above experimental results, it can be found that the protein removal sterilizer combined with physiological saline can achieve a protein elution rate of 88.6% for Haichang Clear Easy six-month disposable hydrogel contact lenses, while the protein elution rate achieved by soaking Haichang Clear Easy six-month disposable hydrogel contact lenses in physiological saline is only 2%. Therefore, the protein removal sterilizer combined with physiological saline can achieve a highly efficient cleaning and restoration effect for Haichang ClearEasy six-month disposable hydrogel contact lenses.

[0106] Example 5:

[0107] An experiment was conducted using the detection method described in Example 2 to determine the elution rate of proteins adsorbed on the surface and within the oxygen-permeable pores of a six-month disposable hydrogel contact lens using a protein removal sterilizer and physiological saline. The experimental steps are as follows:

[0108] 1. Bausch & Lomb Clear 6-month disposable hydrogel soft hydrophilic contact lenses (National Medical Device Registration No. 20163223297, LOT No.: B13404300IEOG0265 / B13404300IEOG0273) for 8 hours. Lens material: polymerized from hydroxyethyl methacrylate (HEMA), N-vinylpyrrolidone (NVP) and colorants, etc., with a water content of 45%.

[0109] 2. After wearing the glasses for 8 hours, remove the left and right lenses and place them into 1.5ml centrifuge tubes respectively. Add 1ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tubes and shake for 30 minutes. Then test the amount of lysozyme in the centrifuge tubes. The values ​​are 0.231mg and 0.227mg respectively. The average amount of protein adsorbed by the lenses after 1 day (8h) of wear is 0.229mg, which means that the original amount of protein in the lenses is 0.229mg.

[0110] 3. Repeat step 1, and have the same person wear Bausch & Lomb Clear 6-month disposable hydrogel soft hydrophilic contact lenses (National Medical Device Registration No. 20163223297, LOT No.: B13404300IEOG0265 / B13404300IEOG0273) for 8 hours to obtain two corneal contact lenses with protein on the surface;

[0111] 4. Take one of the corneal contact lenses from step 3 and soak it in 1 ml of 0.9% physiological saline for 3 minutes. Then put it into a 1.5 ml centrifuge tube and add 1 ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tube. After shaking for 30 minutes, test the amount of lysozyme in the centrifuge tube. It is 0.223 mg.

[0112] 5. Take the other contact lens from step 3 and place it in the protein removal sterilization tank of the protein removal sterilizer. Add 1 ml of 0.9% physiological saline and start the protein removal sterilizer to clean for 3 minutes. During cleaning, measure the voltage across the probe at 4.8V and the current at 4.5mA (the voltage across the probe can be 0.55V-4.8V and the current can be 0.45-4.5mA). After cleaning, place the contact lens into a 1.5 ml centrifuge tube and add 1 ml of acetonitrile-trifluoroacetic acid solution to the centrifuge tube. After shaking for 30 minutes, test the amount of lysozyme in the centrifuge tube. The result is 0.031 mg.

[0113] 6. Calculate the elution rate of proteins adsorbed on the surface and inside the oxygen-permeable pores of a 2-month disposable hydrogel contact lens using a protein removal sterilizer in conjunction with physiological saline:

[0114]

[0115] =(1-0.031 mg / 0.229 mg)*100% =86.5%;

[0116] Similarly, the protein elution rate of a disposable hydrogel contact lens soaked in physiological saline for six months is calculated to be (1-0.223mg / 0.229mg)*100%=2.6%.

[0117] Based on the above experimental results, it can be found that the protein removal sterilizer combined with physiological saline can achieve a protein elution rate of 86.5% for Bausch & Lomb Clear 6-month disposable hydrogel contact lenses, while the protein elution rate achieved by soaking the Bausch & Lomb Clear 6-month disposable hydrogel contact lenses in physiological saline is only 2.6%. Therefore, the protein removal sterilizer combined with physiological saline can achieve a highly efficient cleaning and restoration effect for Bausch & Lomb Clear 6-month disposable hydrogel contact lenses.

[0118] As can be seen from Examples 2-5, the protein removal sterilizer described in this invention, when used with physiological saline, can effectively remove protein from six-month disposable hydrogel soft hydrophilic contact lenses from various brands.

[0119] Example 6:

[0120] To test the cleaning effect of the protein removal and sterilization method described in this invention on six-month disposable hydrogel contact lenses, this invention also proposes a method for testing the protein removal and sterilization effect on six-month disposable hydrogel contact lenses, comprising:

[0121] The sterilization effect of a protein-removing sterilizer combined with physiological saline on six-month disposable hydrogel contact lenses was tested, specifically including:

[0122] Add physiological saline to the protein removal sterilization tank of the protein removal sterilizer, start the protein removal sterilizer, and after a predetermined time, obtain sterilization water stock solution from the protein removal sterilization tank;

[0123] Choose the neutralizing agent and bacterial suspension for the sterilization test.

[0124] The bacterial suspension and organic interfering agent were mixed at a 1:1 ratio and placed in a water bath. After a predetermined time, the obtained sterilization-generating water stock solution was added to obtain a mixture. After a predetermined reaction time, the mixture was mixed with the neutralizing agent at a 1:9 ratio, diluted, inoculated, and viable bacteria were cultured and counted. The log killing effect of the sterilization-generating water stock solution on the bacteria in the bacterial suspension was then detected.

[0125] A bactericidal detection experiment was conducted using the bactericidal detection method described in this embodiment. The bactericidal species involved in the experiment was Escherichia coli. The specific bactericidal detection experiment steps are as follows:

[0126] I. Equipment

[0127] 1. Test strain: Escherichia coli ATCC8099

[0128] 2. Neutralizing agent: D / E neutralizing broth

[0129] 3. Effective concentration: Stock solution (protein removal sterilizer + 0.9% physiological saline generating water, i.e., physiological saline is added to the protein removal sterilizer's sterilization tank, the protein removal sterilizer is started, and after a predetermined time, sterilization generating water stock solution is obtained from the protein removal sterilization tank)

[0130] II. Methods

[0131] 1. Testing Basis: The neutralizing agent identification test and quantitative bactericidal test were conducted in accordance with Articles 2.1.1.5, 2.1.1.7, and 2.1.1.9 of the Ministry of Health's "Disinfection Technical Specifications" (2002 edition).

[0132] The KL standard requirement for the number of bacteria killed is: ≥5.00.

[0133] 2. Neutralizing agent identification test: The neutralizing agent used was D / E to neutralize the broth. The disinfectant concentration was undiluted, and the contact time was 2 minutes. The test was repeated three times, and the test strain was Staphylococcus aureus.

[0134] III. Results

[0135] 1. Neutralizing agent identification test

[0136] Group 1: 1.0 mL of bacterial suspension was added to 4.0 mL of test sample solution and allowed to react for the predetermined time. 0.5 mL of the mixture was then added to 4.5 mL of diluent, and 1.0 mL was aspirated for incubation and counting.

[0137] Group 2: Add 1.0 mL of bacterial suspension to 4.0 mL of test sample solution and let it react for the predetermined time. Take 0.5 mL of the mixture and add 4.5 mL of neutralizing agent. Mix well and let it react for 10 min. Aspirate 1.0 mL for culture and counting. Dilute 10 times with diluent.

[0138] Group 3: Add 0.1 mL of bacterial suspension to 0.4 mL of hard water, mix well, add 4.5 mL of neutralizing agent, mix well and let stand for 10 min, aspirate 1.0 mL for culture and counting, and dilute 10 times with neutralizing agent.

[0139] Group 4: Add 0.1 mL of bacterial suspension to 4.9 mL of neutralization product, mix well for 10 min, aspirate 1.0 mL for incubation and counting, and dilute 10 times with the neutralization product.

[0140] Group 5: Add 0.1 mL of bacterial suspension to 0.4 mL of hard water, mix well, then add 4.5 mL of diluent, mix well and let stand for 10 min, aspirate 1.0 mL for culture and counting, and dilute 10 times with diluent.

[0141] Group 6: 1.0 mL each of diluent, neutralizer and hard water were inoculated onto plates.

[0142] The results of the neutralizing agent identification test are shown in Table 6-1 below.

[0143] Table 6-1 Results of Neutralizer Identification Tests

[0144]

[0145] Analyzing the test results in Table 6-1, no bacteria grew in Group 1, more bacteria were present in Group 2 than in Group 1, but less than in Groups 3, 4, and 5, and similar amounts of test bacteria grew in Groups 3, 4, and 5, with an inter-group error rate of 6.9% (<15%). No bacteria grew in Group 6, and the neutralizing agent was deemed qualified.

[0146] 2. Killing effect on test bacteria

[0147] Take 0.5 mL of bacterial suspension, add 0.5 mL of organic interfering substance, mix well, and incubate in a water bath for 5 min. Then add 4.0 mL of disinfectant and allow to react for the predetermined time. Take 0.5 mL of the mixture and add it to 4.5 mL of neutralizing agent, mix well, and take an appropriate dilution. Inoculate 1.0 mL of the solution into a Petri dish and then perform viable cell culture and counting. At the same time, prepare a control sample. The results are detailed in Table 6-2 below.

[0148] Table 6-2 Logarithmic values ​​(KL) of the samples against the test bacteria

[0149]

[0150] IV. Conclusion

[0151] The sterilization water stock solution described in this embodiment, when reacted for 3 minutes, showed a kill value of >5.00 against Escherichia coli, indicating that the sterilization water stock solution has a killing effect on Escherichia coli.

[0152] Example 7:

[0153] To test the cleaning effect of the protein removal and sterilization method described in this invention on six-month disposable hydrogel contact lenses, this invention also proposes a testing method for the protein removal and sterilization effect of six-month disposable hydrogel contact lenses. This method mainly tests the delipidation effect of the lens, which includes:

[0154] The effectiveness of a protein removal sterilizer combined with physiological saline in removing grease from the surface of a six-month disposable hydrogel contact lens was tested, specifically including:

[0155] The oil content on the surface of a six-month disposable hydrogel contact lens with adsorbed oil was detected.

[0156] Physiological saline was added to the protein removal sterilization tank of the protein removal sterilizer. The six-month disposable hydrogel contact lens with grease adsorbed on its surface was placed in the physiological saline. The protein removal sterilizer was started. After cleaning, the grease content on the surface of the six-month disposable hydrogel contact lens cleaned by the protein removal sterilizer was measured, and the grease removal rate of the six-month disposable hydrogel contact lens by the protein removal sterilizer and physiological saline was measured.

[0157] Furthermore, a fluorescence spectrophotometer can be used to emit a light beam onto the semi-disposable hydrogel contact lens with grease adsorbed on its surface, and the fluorescence intensity value of the emission spectrum can be recorded. The fluorescence intensity value corresponds to the grease content on the surface of the semi-disposable hydrogel contact lens.

[0158] .

[0159] An experiment was conducted to detect the removal of grease from the lens surface as described in this embodiment. The experimental steps are as follows:

[0160] 1. Choose 6-month disposable lenses: Bausch & Lomb Clear 6-month disposable hydrogel soft hydrophilic contact lenses (National Medical Device Registration No. 20163223297, LOT No.: B13404300IEOF3251 / B13404300IEOF2617); Material: Polymerized from hydroxyethyl methacrylate (HEMA), N-vinylpyrrolidone (NVP) and colorants, etc.

[0161] 2. Prepare artificial tears: Phosphatidylcholine - 0.0005 mg / ml, Cholesterol - 0.0018 mg / ml, Lysozyme - 1.9 mg / ml, BSA - 0.2 mg / ml, γ-globulin - 0.1 mg / ml, NaCl - 9 mg / ml, GaCl2•2H2O - 0.25 mg / ml, Na2HPO4•7H2O - 0.28 mg / ml. Adjust the pH to 7.8 using NaOH or HCl.

[0162] 3. In vitro artificial adsorption process for corneal contact lenses: In a sterile environment, take two Bausch & Lomb Clear Lens 6-month disposable lenses and place them in the artificial tear solution prepared in step 2. The artificial tear solution must completely submerge the contact lenses. Then, place them in a 37°C incubator and change the artificial tear solution every 24 hours. After 3 days of adsorption of the deposits, remove the lenses from the solution, rinse them with physiological saline, and then perform the test.

[0163] 4. Fluorescence spectrophotometer test: Excitation wavelength 360nm, emission wavelength 360nm. Place the corneal contact lens after the deposit has been adsorbed in the fluorescence spectrophotometer, with the center of the lens facing the light beam, and record the fluorescence intensity value of the emission spectrum.

[0164] 5. After rinsing the two lenses cultured in step 3 with physiological saline, place them in a fluorescence spectrophotometer for testing and record the fluorescence intensity values ​​of the emission spectrum. The fluorescence intensity before cleaning is 26.5 and 26.7.

[0165] 6. Place the lens with a fluorescence intensity of 26.5 measured in step 5 into the protein removal sterilization tank of the protein removal sterilizer, add 1 ml of 0.9% physiological saline, start the protein removal sterilizer to clean for 3 minutes, take it out and place it in a fluorescence spectrophotometer for testing, record the fluorescence intensity value of the emission spectrum, and obtain the fluorescence intensity after cleaning as 7.6.

[0166] 7. Place the lens with a fluorescence intensity of 26.7 measured in step 5 into the protein removal sterilization tank of the protein removal sterilizer, add 1 ml of 0.9% physiological saline, let it stand and soak for 3 minutes, then take it out and place it in a fluorescence spectrophotometer for testing, record the fluorescence intensity value of the emission spectrum, and obtain the fluorescence intensity after cleaning as 25.4.

[0167] 8. The degreasing rate of the lenses after activating the protein removal sterilizer and cleaning with saline solution in step 6 is calculated as: (26.5-7.6) / 26.5=71.3%;

[0168] The fat removal rate of the lenses soaked in physiological saline in the protein removal sterilizer in step 7 is calculated as follows:

[0169] (26.7-25.4) / 26.7=4.9%.

[0170] Based on the above experimental results, it can be found that the protein removal sterilizer combined with physiological saline can remove 71.3% of the grease on the surface of Bausch & Lomb Clear 6-month disposable hydrogel contact lenses. However, the same lenses soaked in the protein removal sterilizer's sterilization tank with physiological saline can only remove 4.91% of the grease on the lens surface. Therefore, the protein removal sterilizer described in this invention, combined with physiological saline, also has the function of removing lipids when the cleaning is started.

[0171] In summary, this invention discloses a method and testing method for protein removal and sterilization of six-month disposable hydrogel contact lenses. The protein removal and sterilization method can remove proteins, bacteria, and lipids adsorbed on the surface and within the oxygen-permeable pores of the six-month disposable hydrogel contact lenses, achieving a complete restoration of the lenses. This provides consumers with an effective cleaning method for six-month disposable hydrogel contact lenses, ensuring lens safety when in contact with the eyes. The protein removal and sterilization testing method provided by this invention can effectively verify the restoration effect of the protein removal and sterilization method on six-month disposable hydrogel contact lenses. This testing method detects bacteria, proteins, and lipids invisible to the naked eye, providing consumers with test results through chemical experiments. This demonstrates that the protein removal and sterilization method of this invention can clean and restore six-month disposable hydrogel contact lenses, scientifically ensuring that lenses cleaned by the cleaner are safe and harmless, further protecting users' eye safety. Experimental results of the embodiments of this invention show that the protein removal and sterilization instrument of this invention, combined with physiological saline, can perform multi-faceted cleaning and restoration of six-month disposable hydrogel contact lenses, including protein removal, sterilization, and grease removal.

[0172] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0173] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications and variations to the above embodiments within the scope of the present invention.

Claims

1. A method for detecting protein removal and sterilization in semi-annual disposable hydrogel contact lenses, characterized in that, It includes: The elution rate of proteins on hydrogel contact lenses that have undergone protein removal and sterilization six months prior was measured, specifically including: The content of proteins adsorbed on the surface of a six-month disposable hydrogel soft hydrophilic contact lens was measured to obtain the original protein content of the lens. The six-month disposable hydrogel soft hydrophilic contact lens was placed in a protein removal sterilizer and sterilized with physiological saline. The cleaning mode of the protein removal sterilizer was selected, and the six-month disposable hydrogel soft hydrophilic contact lens was placed in the protein removal sterilization tank of the protein removal sterilizer and cleaned with physiological saline for a predetermined time to obtain a six-month disposable hydrogel soft hydrophilic contact lens after protein removal sterilization. The protein content of six-month disposable hydrogel soft hydrophilic contact lenses treated with the aforementioned protein removal sterilizer was measured to obtain the amount of residual protein in the lenses after cleaning. The amount of residual protein on the cleaned lens and the amount of original protein on the lens were calculated and analyzed to obtain the elution rate of protein adsorbed on the surface and oxygen pores of the six-month disposable hydrogel soft hydrophilic contact lens by a protein removal sterilizer combined with physiological saline. It also includes: The surface grease removal effect of a six-month-old disposable hydrogel contact lens sterilized using a protein removal sterilization method was tested, specifically including: The oil content on the surface of a six-month disposable hydrogel contact lens with adsorbed oil was detected. Physiological saline was added to the protein removal sterilization tank of the protein removal sterilizer. The six-month disposable hydrogel contact lens with grease adsorbed on its surface was placed in the physiological saline. The protein removal sterilizer was started. After cleaning, the grease content on the surface of the six-month disposable hydrogel contact lens cleaned by the protein removal sterilizer was measured, and the grease removal rate of the six-month disposable hydrogel contact lens by the protein removal sterilizer and physiological saline was measured.

2. The method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens according to claim 1, characterized in that, The protein content of a six-month disposable hydrogel soft hydrophilic contact lens was detected after treatment with the aforementioned protein removal sterilizer, and the amount of residual protein in the lens after cleaning was obtained, specifically including: The six-month-old disposable hydrogel soft hydrophilic contact lens, which had been treated by the protein removal sterilizer, was placed in the protein extraction solution, and the protein was extracted by vibration. The protein concentration in the protein extract was detected using a micro-ultraviolet spectrophotometer, and the amount of remaining protein in the lens after cleaning was calculated from the protein concentration value.

3. The method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens according to claim 2, characterized in that, The predetermined time is 3 minutes. During the process of cleaning the semi-annual disposable hydrogel soft hydrophilic contact lens using the protein removal sterilizer, the voltage difference between the two electrophoretic dissociation probes in the protein removal sterilizer tank is 0.55V-4.8V, and the current value is 0.45-4.5mA.

4. The method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens according to claim 2, characterized in that, The protein extraction solution is composed of 50 parts acetonitrile, 50 parts deionized water and 0.2 parts 100% trifluoroacetic acid; The amount of residual protein on the cleaned lens was calculated and analyzed in conjunction with the amount of original protein on the lens to obtain the elution rate of proteins adsorbed on the surface and within the oxygen-permeable pores of a six-month disposable hydrogel soft hydrophilic contact lens using a protein removal sterilizer and physiological saline. 。 5. The method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens according to claim 1, characterized in that, It also includes: The sterilization effect of six-month disposable hydrogel contact lenses sterilized using a protein removal sterilization method was tested, specifically including: Add physiological saline to the protein removal sterilization tank of the protein removal sterilizer, start the protein removal sterilizer, and after a predetermined time, obtain sterilization water stock solution from the protein removal sterilization tank; Choose the neutralizing agent and bacterial suspension for the sterilization test. The bacterial suspension and organic interfering agent were mixed in a 1:1 weight ratio and placed in a water bath. After a predetermined time, the obtained sterilization generating water stock solution was added to obtain a mixture. After a predetermined reaction time, the mixture was mixed with the neutralizing agent in a 1:9 weight ratio, diluted, inoculated, and viable bacteria were cultured and counted. The log killing effect of the sterilization generating water stock solution on the bacteria in the bacterial suspension was then detected.

6. The method for detecting protein removal and sterilization of a six-month disposable hydrogel contact lens according to claim 1, characterized in that, A fluorescence spectrophotometer is used to emit a light beam onto the semi-disposable hydrogel contact lens with grease adsorbed on its surface, and the fluorescence intensity value of the emitted spectrum is recorded. The fluorescence intensity value corresponds to the grease content on the surface of the semi-disposable hydrogel contact lens. 。 7. A method for detecting protein removal and sterilization of semi-annual disposable hydrogel contact lenses, characterized in that, It includes: A protein removal sterilizer is provided, wherein the protein removal sterilizer has a protein removal sterilization tank, and at least two electrophoretic dissociation probes are provided in the protein removal sterilization tank; Add physiological saline and a 2-month disposable hydrogel contact lens into the protein removal sterilization tank, start the protein removal sterilizer, and energize the two electrophoretic dissociation probes, with one electrophoretic dissociation probe as the positive electrode and the other electrophoretic dissociation probe as the negative electrode; The proteins attached to the surface of the semi-annual hydrogel contact lens are charged in the physiological saline, and the charged proteins move toward the electrode position with the opposite charge. Cl in physiological saline - The protein moves toward the positive electrode and loses electrons, becoming oxidized into chlorine gas. The chlorine gas dissolves in the physiological saline to generate hypochlorous acid. The hypochlorous acid reacts with the protein in the protein removal sterilization tank, causing the protein to be degraded. The hypochlorous acid undergoes a self-redox reaction in the physiological saline, decomposing into hydrogen ions, chloride ions and oxygen. During the decomposition process, the hypochlorous acid absorbs electrons from the functional proteins of the microorganisms in the protein removal sterilization tank, thereby inactivating the functional proteins of the microorganisms and killing the microorganisms. It also includes: The surface grease removal effect of a six-month-old disposable hydrogel contact lens sterilized using a protein removal sterilization method was tested, specifically including: The oil content on the surface of a six-month disposable hydrogel contact lens with adsorbed oil was detected. Physiological saline was added to the protein removal sterilization tank of the protein removal sterilizer. The six-month disposable hydrogel contact lens with grease adsorbed on its surface was placed in the physiological saline. The protein removal sterilizer was started. After cleaning, the grease content on the surface of the six-month disposable hydrogel contact lens cleaned by the protein removal sterilizer was measured, and the grease removal rate of the six-month disposable hydrogel contact lens by the protein removal sterilizer and physiological saline was measured.

8. The method for detecting protein removal and sterilization of a semi-annual disposable hydrogel contact lens according to claim 7, characterized in that, It also includes: Positively charged hydrogen ions in the saline solution move towards the negative electrode and undergo a reduction reaction near the negative electrode to generate hydrogen gas. Sodium ions in the saline solution react with hydroxide ions to generate sodium hydroxide. The grease on the surface of the six-month disposable hydrogel contact lens undergoes a saponification reaction with the sodium hydroxide, and the grease on the surface of the six-month disposable hydrogel contact lens is removed.

9. The method for detecting protein removal and sterilization of a semi-annual disposable hydrogel contact lens according to claim 7, characterized in that, The hypochlorous acid reacts with the protein in the protein removal sterilization tank via a redox reaction, resulting in protein degradation. Specifically, this includes: The hypochlorous acid reacts with the peptide chains that form the protein backbone to yield chloral-formamide. The peptide chains formed by chloral-formamide are then hydrolyzed in solution, resulting in the breakage of peptide bonds and decomposition into small protein molecules and amino acids. This protein degradation, and / or... The hypochlorous acid reacts with the side chains of the peptide chains that form the protein backbone, the side chains including lysine side chains. The hypochlorous acid reacts with the lysine side chains to form chloramine on the lysine side chains and the amino groups of the protein. The chloramine decomposes to form organic molecular fragments in the form of carbonyl groups [1,2]. The peptide bonds on the lysine side chains break, decomposing into small molecule proteins and amino acids, and the protein is degraded.

10. The method for detecting protein removal and sterilization of a semi-annual disposable hydrogel contact lens according to claim 7, characterized in that, The microorganisms include bacteria and viruses. During the decomposition process, the hypochlorous acid absorbs electrons from functional proteins on the cell walls of the bacteria, thereby inactivating the bacteria. During the decomposition process, the hypochlorous acid absorbs electrons from the functional proteins on the outer shell of the virus, thereby inactivating the virus. The hypochlorous acid has strong oxidizing properties. It penetrates into the microbial cells and reacts with the microbial proteins, nucleic acids, and enzymes within the cells to kill the microorganisms.

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