Pretreatment humectant with disinfection function for reusable diagnosis and treatment instruments

Abstract

The invention discloses a pretreatment humectant with a disinfection function for reusable diagnosis and treatment instruments, which comprises nano-metal peroxide sustained-release particles, an infiltration component, a moisturizing component and a foaming component, and further improves, optimizes and balances the disinfection effect and the cleaning effect of materials. Therefore, a four-dimensional synergistic mechanism of slow-release embedding, foaming, infiltration and moisturizing components of the nano-metal peroxide provided by the invention is achieved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of disinfection and moisturizing, and particularly relates to a pretreatment moisturizer with disinfection function for multipurpose medical instruments. BACKGROUND

[0002] At present, similar products on the market are divided into two categories: 1. simple moisturizers, and 2. pretreatment moisturizers containing multiple enzymes. First, the existing conventional simple moisturizers have single function, can only delay the drying process of surface contaminants of the instruments, cannot remove surface contaminants (including proteins, lipids, gums, and general contaminants), and do not have sterilization ability, so they cannot effectively inhibit pathogenic microorganisms. Furthermore, although the pretreatment moisturizers containing multiple enzymes have the ability to remove surface contaminants, they face multiple problems in actual application. On the one hand, their production cost is high, which is not conducive to large-scale popularization and use. On the other hand, the multiple enzyme components have safety hazards in the spraying operation process, which may cause direct harm to the skin and mucous membranes of the operators and trigger health problems such as allergic reactions. Thirdly, the pretreatment moisturizer of this type contains multiple enzymes, and multiple enzymes are the key to cleaning. However, if disinfecting factors are added at the same time of pretreatment, the protein will be denatured with high probability, and the multiple enzymes as proteins will be interfered by the disinfecting factors, which will limit the subsequent cleaning efficiency. Therefore, cleaning and disinfection are contradictory here.

[0003] Secondly, the mechanism of action of traditional disinfecting factors has defects: they make the protein and other contaminants on the surface of the instruments denature and coagulate, which greatly increases the difficulty of subsequent cleaning and reduces the efficiency of instrument reuse. Therefore, the traditional disinfecting factors cannot be compatible with the existing moisturizer components.

[0004] In addition, the auxiliary components, buffer salts and chelating agents added to ensure the stability of multiple enzymes will have a corrosive effect on metal instruments, thereby affecting the service life and safety of the instruments.

[0005] Moreover, the peroxide mechanism itself has biochemical defects. First, the concentration effect, low concentration of peroxide usually leads to non-covalent aggregation between protein subunits (such as enhanced hydrophobic interaction, electrostatic interaction), which shows reversible or looser aggregation. High concentration of peroxide is more likely to induce oxidative modification of protein side chains (especially sulfur-containing amino acids such as cysteine and methionine), leading to irreversible covalent cross-linking (such as disulfide bond, carbonyl derivative cross-linking), forming large, insoluble aggregates. This is consistent with the classic mechanism of protein oxidative damage. Second, the pH effect, pH affects the denaturation and aggregation of proteins by affecting their net charge, conformational stability, and reactivity of amino acid side chains. The isoelectric point (pI) of hemoglobin is about 6.8. At acidic pH (<pI), hemoglobin is positively charged, and the intermolecular repulsion is relatively small, and the acidic environment itself may promote certain denaturation processes, making it more prone to flocculation. At alkaline pH (>pI), hemoglobin is negatively charged, and the intermolecular repulsion increases, and it is usually more stable and less likely to aggregate. In a medical environment, the instrument transfer process is prone to cause the instrument to be placed for a long time. In the epidemic situation caused by infectious pathogenic microorganisms or unknown bacteria, because the existing moisturizing agent has no sterilization function, it cannot control microbial contamination, and is prone to cause a large number of pathogenic microorganisms to reproduce during transfer, thereby causing the risk of infection and transmission. When the hospital supply room transfers the instrument, the transfer box is closed, and when it is opened after being placed for a long time, the concentration of pathogenic microorganisms in the box is much higher than that in the outside world, which has the risk of escaping and threatens the safety of medical staff in the supply room and related departments.

[0006] In view of the above technical difficulties, the present application realizes a low-concentration peroxide slow-release synergistic system under the condition of protein alkaline hydrolysis at pH 8.0-9.5 through the creative four-dimensional synergistic mechanism of nano-metal peroxide slow-release embedding, foaming, infiltration and moisturizing ingredients, which significantly improves the cleaning effect and innovatively integrates the continuous sterilization function, thereby completely solving the core defects of insufficient microbial control and mutual exclusion of moisturizing and disinfection functions in the prior art. The mechanism simultaneously realizes dynamic protection (continuous inhibition of microbial reproduction during instrument transfer) and basic non-corrosion (inhibitor + low surface tension synergistic protection of instruments), thereby constructing a "disinfection-cleaning-moisturizing-corrosion prevention" integrated technology guarantee for medical instrument safety pretreatment. SUMMARY

[0007] The technical problem to be solved by the present application is to overcome the defects that conventional peroxide cannot be stably present in a weak alkaline moisturizing agent environment and increases cleaning difficulty, and that ordinary peroxide, moisturizing, and surface active ingredients cannot achieve good moisturizing pretreatment effect by simple collocation, and to provide a pretreatment moisturizing agent with disinfection function for multipurpose medical treatment instruments, which further improves, optimizes, and balances the disinfection effect, cleaning effect, and other performances of the material, and achieves the four-dimensional synergistic mechanism of nano-metal peroxide slow-release embedding, foaming, infiltration, and moisturizing ingredients proposed in the present application.

[0008] To achieve the above object, the present application adopts the following technical scheme: The present application provides a pretreatment moisturizing agent with disinfection function for multipurpose medical treatment instruments, comprising nano-metal peroxide slow-release particles, infiltration ingredients, moisturizing ingredients, and foaming ingredients.

[0009] In the above technical scheme, the pretreatment moisturizing agent has a pH of 7.8-9.8, a surface tension of 24.9-27.5 mN / m, a contact angle of 17°-25°, and a H2O2 release rate of 0.75-1.2 μg·mL⁻¹·min⁻¹.

[0010] In the above technical scheme, the pretreatment moisturizing agent is one of a powder, a gel, an aqueous agent, and a paste.

[0011] In the above technical scheme, the pretreatment moisturizing agent comprises, by weight percentage, 25%-30% of nano-metal peroxide slow-release particles, 7%-11% of infiltration ingredients, 15%-22% of moisturizing ingredients, and 30%-40% of foaming ingredients, has a pH of 8.5-9.0, a surface tension of 25-27 mN / m, a contact angle of 19°-22°, and a H2O2 release rate of 0.8-0.9 μg·mL⁻¹·min⁻¹.

[0012] In the above technical scheme, the pretreatment moisturizing agent comprises, by weight percentage, 23%-28% of nano-metal peroxide slow-release particles, 11%-16% of infiltration ingredients, 20%-28% of moisturizing ingredients, and 25%-32% of foaming ingredients, has a pH of 7.8-8.2, a surface tension of 26-27.5 mN / m, a contact angle of 22°-25°, and a H2O2 release rate of 0.75-0.85 μg·mL⁻¹·min⁻¹.

[0013] In the above technical solution, the pre-treatment moisturizer comprises, by weight percentage, 23-28% of nano metal peroxide slow-release particles, 2-5% of infiltration ingredients, 5-12% of moisturizing ingredients, and 45-52% of foaming ingredients, the pH of the pre-treatment moisturizer is 9.2-9.8, the surface tension is 24-26 mN / m, the contact angle is 17-20°, and the H2O2 release rate is 1.0-1.2 μg·mL⁻¹·min⁻¹.

[0014] In the above technical solution, the nano metal peroxide comprises one or more of the following: sodium peroxide (Na2O2), calcium peroxide (CaO2), magnesium peroxide (MgO2), zinc peroxide (ZnO2), barium peroxide (BaO2), and titanium oxide (TiOx); the slow-release embedding material comprises one or more of the following: polyacrylic acid (PAA), polydopamine (PDA), sodium alginate (SA), and the nano metal peroxide slow-release particles obtained by processing through methods including, but not limited to, reverse microemulsion method and gas diffusion method.

[0015] In the above technical solution, the infiltration ingredients comprise one or more of the following: sucrose ester SE-15, glycerol monostearate (GMS), polyglycerol fatty acid ester (such as decaglycerol monolaurate), soybean phospholipid (lecithin), chitosan fatty acid ester, polyoxyethylene sorbitan fatty acid ester (Tween-20 / 80), alkyl polyglycoside (APG-1214), and trehalose.

[0016] In the above technical solution, the moisturizing ingredients comprise one or more of the following: trehalose, maltose, lactose, beta-cyclodextrin (β-CD), hyaluronic acid (HA), collagen peptide, polyethylene glycol (PEG-400), sorbitol, xylitol, maltitol, erythritol, 1,3-butanediol, propylene glycol, and inositol.

[0017] In the above technical solution, the foaming ingredients comprise one or more of the following: sodium dodecylbenzenesulfonate SDBS, sodium dodecyl sulfate, dioctyl sodium sulfosuccinate, disodium sulfosuccinimidodiacetate, sodium fatty acid methyl sulfonate, polyoxyethylene dodecyl ether phosphate ester salt or nonylphenol polyoxyethylene ether sulfosuccinate disodium salt, cetyltrimethylammonium bromide, dodecyltrimethylammonium bromide, myristyltrimethylammonium bromide, or cetyltrimethylammonium chloride, sodium alpha-olefin sulfonate AOS, and cocamide propyl betaine CAPB.

[0018] The present application has the following beneficial effects: 1. Moisturizing, pollutant decomposition, and sterilization functions in one, filling the technical gap: Prior art problems: existing conventional moisturizers can only delay the drying of pollutants and do not have sterilization and decontamination functions; traditional disinfectants cannot be compatible with moisturizers, and easily cause protein coagulation, increasing the difficulty of cleaning.

[0019] The present application: innovatively develops a powder-like pretreatment moisturizer with the functions of moisturizing, disinfecting and decomposing. The core is that through the multi-component synergistic mechanism of nano-metal peroxide slow-release particles (such as nCaO2@PDA), foaming ingredients (AOS / SDBS / CAPB), infiltrating ingredients (sucrose ester SE-15 / trehalose), and moisturizing ingredients (sorbitol / xylitol / trehalose), the sustained release of active oxygen (·OH / H2O2) is synergistically regulated in a weak alkaline environment (such as the H2O2 release rate of 0.85±0.03 μg·mL⁻¹·min⁻¹ in Example 1), avoiding protein coagulation caused by explosive oxidation, and avoiding the rapid inactivation of common peroxides under alkaline conditions.

[0020] Synergistic effect: it can not only ensure excellent moisturizing effect (the moisturizing time of Example 1 is up to 25 hours), but also achieve efficient sterilization within 3 minutes (the killing logarithm of Example 1 to Escherichia coli is Log5, and the inactivation rate is 99.999%), and effectively decompose proteins and ATP (the protein residue of Example 1 is only 0.06 μg per piece, and the ATP is 0.62 RLU per piece).

[0021] Comparison proves: traditional ordinary moisturizers (such as Comparative Example 2) can only delay the drying of pollutants on the surface of the equipment, the killing logarithm of Escherichia coli is 0, and they completely do not have sterilization and decomposition ability, the ATP residue is as high as 2.2 RLU per piece (more than 3.5 times of Example 1 of the present application), and the protein residue is 0.2 μg per piece (3.3 times of Example 1 of the present application). The present application realizes the three-in-one function of "moisturizing-disinfecting-decomposing organic matter" in the moisturizer for the first time through multi-component synergy, solving the core defects of traditional products that cannot inhibit microbial reproduction and have single function.

[0022] 2. Comprehensive optimization of performance, far superior to similar products: Disinfection performance: the killing logarithm of Examples 1-3 to Escherichia coli (3min Log3.8-5.0, still Log5 after 8h) is far superior to ordinary moisturizers (Log0) and composite multi-enzyme moisturizers (Log1). This is due to the sustained and stable release mechanism of active oxygen achieved by the synergistic effect of nano-metal peroxide slow-release particles in the weak alkaline environment maintained by the moisturizing component, the foaming component, and the infiltrating component. The problem of rapid inactivation of peroxide under alkaline conditions is successfully solved, which provides a prerequisite for protein hydrolysis and removal under alkaline conditions, achieving pH-peroxide slow-release synergistic balance (Comparative Example 6 proves that common peroxide without slow-release structure cannot achieve long-acting disinfection).

[0023] Cleaning effect: The ATP residual (Example 1-3: 0.43-0.75 RLU / piece) and protein residual (0.05-0.07 μg / piece) values after cleaning are significantly lower than those of traditional products. This is due to the significant reduction in surface tension (24.9-26.7 mN / m) of the foaming ingredients (AOS / SDBS / CAPB) in the synergistic system, the optimization of the contact angle (18-24°) by the synergistic infiltration ingredients (sucrose ester SE-15 / trehalose), which greatly improves the permeability and wettability, enabling the surfactant system to efficiently emulsify biological residues, while the active oxygen released by the slow-release particles effectively decomposes organic matter. (Comparative Examples 3 and 4 prove that the absence of foaming or infiltration ingredients results in an increase in surface tension and contact angle, leading to a significant increase in protein residue to 0.14 μg / piece and 0.67 μg / piece, respectively).

[0024] Instrument compatibility and safety: The product of the present application has no corrosion (relying on the synergistic effect of nano-metal peroxide slow-release mechanism and BTA corrosion inhibitor) and no mucous membrane irritation (benefiting from the mild surfactant CAPB), while the composite multi-enzyme moisturizing agent has moderate corrosion and strong irritation problems.

[0025] Overall performance: Through the precise synergistic combination of nano-metal peroxide slow-release particles and foaming, infiltration, and moisturizing ingredients, the overall performance achieves a synergistic breakthrough in efficient disinfection, deep cleaning, and instrument protection, far surpassing existing similar products.

[0026] Comparison: The composite multi-enzyme moisturizing agent (Comparative Example 1) has cleaning effect (protein residue 0.05 μg / piece), but weak disinfection performance (kill logarithm only 1) and moderate corrosion risk; Example 3 of the present application activates the disinfection potential through the synergistic oxidation effect of the high proportion (20%) of foaming core ingredient AOS and nano-metal peroxide and sodium percarbonate in the strong alkaline environment, achieving a kill logarithm of 4.5 in 3 minutes and maintaining 5 after 8 hours, while the protein residue of 0.07 μg / piece is better than the industry standard, and the surface tension of 24.9 mN / m is suitable for vertical surface wall treatment, significantly improving the overall performance.

[0027] 3. Precise scene adaptation to meet diverse needs: The present application: By designing three differentiated examples, adjusting the synergistic ratio between foaming, infiltration, and moisturizing ingredients and nano-metal peroxide slow-release particles, and precisely responding to different clinical scene needs.

[0028] Synergistic ratio for scene adaptation: Example 1 (pH 8.8, balanced type): In a neutral to alkaline environment, the slow-release particles (27.5%) and the foaming, infiltration, and moisturizing ingredients synergistically balance disinfection and cleaning, with a surface tension of 25.9 mN / m and a flowability of "medium", suitable for general-purpose instruments (such as lumen, shaft joint type) pretreatment.

[0029] Example 2 (pH 8.0, cleaning-enhanced): In weakly alkaline environment, the proportion of infiltrating core sucrose ester SE-15 (6.50%) is increased, the synergy with the foaming and slow-release particles is optimized, the emulsification efficiency and liquid film spreading property (contact angle 24°) are enhanced, the ATP residue is as low as 0.43 RLU / piece, the flowability is "low" to adapt to high-pressure spraying, and it is suitable for complex structure instruments (such as endoscopes and precision parts).

[0030] Example 3 (pH 9.5, disinfection-enhanced): In slightly alkaline environment, the proportion of foaming core AOS (20.00%) is greatly increased, the moisturizing / infiltrating components are simplified, the strong oxidation is activated by the synergy of sodium percarbonate and slow-release particles, the highest immediate killing (Log 4.5) and ultra-low surface tension (24.9 mN / m) are achieved, the flowability is "strong" and the adhesion is good, and it is suitable for heavily contaminated and high-microbial load instruments.

[0031] Limitations of the comparison: traditional products have single performance (such as pure moisturizing agents only for moisturizing, and multi-enzyme moisturizing agents for cleaning but weak disinfection and antagonism with enzymes), which cannot meet the full-scene demand of "general balance-complex cleaning-severe disinfection". The present application realizes scene-based precise adaptation through flexible matching of multi-component synergy mechanism.

[0032] 4. Safety and economy, conducive to popularization and application: Safety: no mucous membrane irritation (CAPB optimized biocompatibility), low odor grade (synergy system optimized), and no harm to operators (compared with strong irritation and allergenic risk of multi-enzyme moisturizing agents).

[0033] Economy: avoid using expensive multi-enzyme components (pain point of high cost of traditional multi-enzyme moisturizing agents), reduce production cost. At the same time, excellent comprehensive performance and scene adaptability reduce repeated processing or instrument damage due to poor effect.

[0034] Synergy advantage: the synergy system of nano-metal peroxide slow-release particles and foaming, infiltrating and moisturizing components itself does not depend on high-cost multi-enzyme, and the single-use cost is reduced through high efficiency (such as clinical verification of 35% reduction in single-instrument pretreatment cost). The dual advantages of safety and economy make it more conducive to large-scale popularization and application in medical and other fields. DETAILED DESCRIPTION

[0035] In order to better illustrate the purpose, technical scheme and advantages of the present application, the present application will be further described below in combination with specific embodiments. The present application can be implemented in many different forms, and should not be understood as being limited to the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure will be thorough and complete, and will fully convey the concept of the present application to those skilled in the art, and the present application will be limited only by the claims.

[0036] The application provides a pretreatment moisturizer with disinfection function for multiplexing diagnosis and treatment instruments, comprising nano-metal peroxide sustained-release particles, infiltration ingredients, moisturizing ingredients and foaming ingredients. The core innovation is to realize the three-in-one function of "moisturizing-disinfection-decomposition" through the multi-component synergistic mechanism of the nano-metal peroxide sustained-release embedding ingredients and the foaming, infiltration and moisturizing ingredients. The core effective ingredients and mechanism are the dynamic synergistic compatibility system of the nano-metal peroxide sustained-release particles and the foaming ingredients, the infiltration ingredients and the moisturizing ingredients, which can achieve the following effects: 1. Synergistically regulate the sustained release of active oxygen (·OH / H2O2), and avoid protein coagulation caused by explosive oxidation.

[0037] 2. Synergistically regulate the liquid surface tension to significantly reduce the liquid contact angle, and significantly improve the permeability and wettability.

[0038] 3. Synergistically regulate the sugar alcohol network to lock water, and the specific sugar alcohol moisturizing ingredients in the specific weak alkaline environment pH value are synergized by the nano-metal peroxide sustained-release particles to release peroxide oxidation-emulsification, so that the sustained decomposition ability and moisturizing effect of peroxide are significantly improved.

[0039] The pretreatment moisturizer of the application is one of a powder, a gel, a water agent and a paste.

[0040] The pH of the pretreatment moisturizer of the application is 7.8-9.8, the surface tension is 24.9-27.5 mN / m, the contact angle is 17°-25°, and the H2O2 release rate is 0.7-1.2 μg·mL⁻¹·min⁻¹.

[0041] During conventional pretreatment, the formula needs to be balanced and synergistic, and is suitable for surgical instruments, and has a Log5.0 sterilization rate and a 0.62RLU / piece residual control. According to the weight percentage, it comprises nano-metal peroxide sustained-release particles 25%-30%, infiltration ingredients 7%-11%, moisturizing ingredients 15%-22% and foaming ingredients 30%-40%, the pH of the pretreatment moisturizer is 8.5-9.0, the surface tension is 25-27 mN / m, the contact angle is 19°-22°, and the H2O2 release rate is 0.8-0.9 μg·mL⁻¹·min⁻¹.

[0042] As one of the embodiments, the infiltration ingredients are sucrose esters 2%-5%+ trehalose 3%-7%, the moisturizing ingredients are polyols 10%-15%+ sugar alcohols 5%-8%, and the foaming ingredients are anionic surfactants 20%-28%+ amphoteric surfactants 8%-12%.

[0043] For complex structure instruments, the formula needs to strengthen the cleaning synergy, ATP residue is as low as 0.43 RLU / piece, surface tension 26.7 mN / m enhances ductility, suitable for precision instruments such as endoscopes. By weight percentage, it includes nano-metal peroxide slow-release particles 23%-28%, infiltration ingredients 11%-16%, moisturizing ingredients 20%-28%, and foaming ingredients 25%-32%. The pretreatment moisturizer has a pH of 7.8-8.2, a surface tension of 26-27.5 mN / m, a contact angle of 22°-25°, and a H2O2 release rate of 0.75-0.85 μg·mL⁻¹·min⁻¹.

[0044] As one of the embodiments, the infiltration ingredients are sucrose esters 5%-8%+ trehalose 4%-9%, the moisturizing ingredients are polyols 10%-15%+ sugar alcohols 9%-14%, and the foaming ingredients are anionic surfactants 15%-20%+ amphoteric surfactants 8%-13%.

[0045] For severe pollution / high microbial load, the formula strengthens disinfection synergy, Log 4.5 instant kill, 98% biofilm clearance rate, no risk of protein coagulation, suitable for infectious disease rooms and epidemic instruments. By weight percentage, it includes nano-metal peroxide slow-release particles 23%-28%, infiltration ingredients 2%-5%, moisturizing ingredients 5%-12%, and foaming ingredients 45%-52%. The pretreatment moisturizer has a pH of 9.2-9.8, a surface tension of 24-26 mN / m, a contact angle of 17°-20°, and a H2O2 release rate of 1.0-1.2 μg·mL⁻¹·min⁻¹.

[0046] As one of the embodiments, the infiltration ingredients are sucrose esters 1%-3%+ trehalose 1%-3%, the moisturizing ingredients are polyols 3%-7%+ sugar alcohols 2%-5%, and the foaming ingredients are anionic surfactants 30%-38%+ amphoteric surfactants 12%-16%.

[0047] Among them, nano-metal peroxide: includes but is not limited to the following substances or their combinations: sodium peroxide (Na2O2), calcium peroxide (CaO2), magnesium peroxide (MgO2), zinc peroxide (ZnO2), barium peroxide (BaO2), and titanium oxide (TiOx), collectively abbreviated as POX (peroxide).

[0048] Slow-release embedding material: includes but is not limited to polyacrylic acid (PAA), polydopamine (PDA), sodium alginate (Sodium alginate, SA), and nano-metal peroxide after embedding by methods including but not limited to reverse microemulsion method and gas diffusion method.

[0049] Surfactant (foaming ingredient): includes but not limited to at least one of the following or combination thereof: sodium dodecyl benzene sulfonate (SDBS), sodium dodecyl sulfate, sodium dioctyl sulfosuccinate, disodium sulfosuccinimidodiacetate, fatty acid methyl sulfonate sodium, polyoxyethylene lauryl ether phosphate ester or nonylphenol polyoxyethylene ether sulfosuccinic acid monoester disodium salt, cetyl trimethyl ammonium bromide, dodecyl trimethyl ammonium bromide, tetradecyl trimethyl ammonium bromide or cetyl trimethyl ammonium chloride, alpha-olefin sulfonate (AOS), cocamidopropyl betaine (CAPB).

[0050] Infiltrating ingredient: includes but not limited to at least one of the following or combination thereof: sucrose ester SE-15, glycerol monostearate (GMS), polyglycerol fatty acid ester (such as decaglycerol monolaurate), soybean phospholipid (lecithin), chitosan fatty acid ester, polyoxyethylene sorbitan fatty acid ester (Tween-20 / 80), alkyl glycoside (APG-1214), trehalose.

[0051] Sugar alcohol ingredient (moisturizing ingredient) includes but not limited to at least one of the following or combination thereof: trehalose, maltose, lactose, beta-cyclodextrin (β-CD), hyaluronic acid (HA), collagen peptide, polyethylene glycol (PEG-400), sorbitol, xylitol, maltitol, erythritol, 1,3-butanediol, propylene glycol, inositol.

[0052] Their most basic function or role: in weak alkaline moisturizing environment, through the dynamic synergy of three types of ingredients by nano-metal peroxide slow-release structure: foaming ingredient reduces surface tension to 25.9 mN / m (increases to 42.1 mN / m when missing), infiltrating ingredient optimizes the contact angle to 20° (protein residue increases to 0.67 μg / piece when missing), and moisturizing ingredient maintains a 24.6-hour wet environment (moisturizing time drops to 5 hours when missing), while ensuring excellent moisturizing effect, continuously releasing strong oxidizing substances, achieving 3-minute Escherichia coli Log5 (99.999% inactivation rate) and decomposing protein / ATP to 0.06 μg / piece, and finally achieving the "moisturizing-disinfecting-decomposing" three-in-one function. The technical feature is to break through the defects of mutual exclusion of disinfection and moisturizing function, high surface tension, and high residual rate of instrument gap in traditional products, and to form a dynamic balance between active oxygen release rate and surface active emulsification, moisturizing environment through multi-component synergy.

[0053] In addition, the formula of the present application can also contain auxiliary oxidation ingredients, such as sodium percarbonate. As an auxiliary oxidation ingredient, sodium percarbonate cooperates with nano-metal peroxide slow-release particles to release active oxygen (・OH / H2O2), enhances the oxidative decomposition ability of stubborn organic matter (such as dry blood stains and protein films), and at the same time, assists the foaming ingredient to improve the emulsification efficiency and strengthen the cleaning effect.

[0054] Sodium percarbonate is a non-core essential component, but it is a preferred component. Its role can be replaced by increasing the proportion of nano-metal peroxide slow-release particles or adding other auxiliary oxidants (such as sodium perborate). The core is to maintain the synergistic balance of the oxidation ability of the system and the emulsification efficiency of the surfactant. Alternative substances include sodium perborate, urea peroxide, etc., which need to meet the stable release of active oxygen in a weak alkaline environment (pH 7.8-9.8), and do not interfere with the slow-release characteristics of nano-metal peroxide and the synergistic effect of foaming / wetting / moisturizing ingredients.

[0055] In addition, the formula of the present application can also contain corrosion inhibitors, such as benzotriazole BTA. The role of corrosion inhibitors is to avoid secondary residues caused by corrosion of the instrument, and to jointly ensure cleaning effect. Other corrosion inhibitors can also be selected, including inorganic corrosion inhibitors, organic corrosion inhibitors, and polymer corrosion inhibitors. Inorganic corrosion inhibitors mainly include chromate, nitrite, silicate, molybdate, tungstate, polyphosphate, zinc salt, etc. Organic corrosion inhibitors mainly include phosphonic acid (salt), phosphonic acid, lyl benzothiazole, benzotriazole, sulfonated lignin, and some nitrogen-containing heterocyclic compounds. Polymer corrosion inhibitors mainly include polyethylene, POCA, polyaspartic acid, and some oligomer macromolecular chemicals.

[0056] As one of the embodiments, the product formula of the present application is shown in Table 1 according to the mass percentage components.

[0057] Table 1 Product formula

[0058] The specific production process of the product shown in Table 1 is as follows: (1) Preparation of slow-release nano calcium peroxide (nCaO2@PDA) (reverse microemulsion method) 1) Accurate proportioning: accurately weigh a certain amount of calcium chloride (CaCl2), sodium dihydrogen phosphate (NaH2PO4) and cetyltrimethylammonium bromide (CTAB), for example, take 4.5g of calcium chloride, 0.4g of sodium dihydrogen phosphate and 0.8g of CTAB, to improve the stability and dispersibility of nano calcium peroxide.

[0059] 2) Ultrasonic dispersion: add the above substances to a proper amount of deionized water, and put them into an ultrasonic cleaner for ultrasonic treatment for 15 minutes. 45-50Hz. Make the components fully dispersed and uniform.

[0060] 3) Uniform stirring: transfer the ultrasonic solution to a conical flask, place it on a magnetic stirrer, and stir at a constant speed of 270r / min, while slowly adding 14ml of 1mol / L ammonia.

[0061] 4) Precise drop of hydrogen peroxide: 14ml of 30% H2O2 is slowly dropped using a constant flow pump, the dropping speed is controlled to ensure the reaction proceeds smoothly.

[0062] 5) Precipitation and washing: when the solution becomes a light yellow viscous liquid, precipitate with sodium hydroxide, then wash with ammonia solution three times and anhydrous ethanol twice under centrifugal conditions to improve the purity of the product.

[0063] 6) Drying and storage: the washed CaO2 precipitate is placed in a vacuum drying oven and dried at 75°C for 2.5h until completely dry, and then sealed and stored.

[0064] (2) The sodium percarbonate in the formula in Table 1 above is ground at low temperature and sieved, and particles with a particle size of not more than 150μm are taken, then mixed with α-sodium alkenyl sulfonate AOS, sodium dodecylbenzenesulfonate SDBS, (cocamidopropyl betaine) CAPB, benzotriazole (BTA) in proportion, and then added to the auxiliary mixing barrel for thorough mixing to obtain a mixture A (weak alkaline foaming core).

[0065] (3) Sorbitol, xylitol, sucrose ester SE-15, trehalose in the formula in Table 1 above are added to the auxiliary mixing barrel in proportion and mixed to obtain a mixture B (moisturizing and infiltrating core).

[0066] (4) The mixture in steps 1-3 is filled into the finished product package in proportion (A: 45.5%, B: 27%, nano-metal peroxide slow-release particles: 27.5%) to obtain the powdery pretreatment moisturizer of the application, which is then stored in a well-sealed container.

[0067] (5) 16.8g of the above product is dissolved in 1000g of water to obtain a powdery pretreatment moisturizer solution for reuse of medical instruments with disinfection function, wherein the peroxide concentration is not less than 1000mg / L.

[0068] In order to better reflect the performance of the product of the application and prove that there is a significant synergistic effect between the nano-metal slow-release embedding material and the foaming, infiltrating and moisturizing components, the following tests are made, and two other formulas and six comparative examples (multi-enzyme moisturizer and ordinary moisturizer, no foaming component, no infiltrating core, no moisturizing core and no nano slow-release material) are developed for comparison test, and the test results are shown in Table 2 below.

[0069] Table 2: Performance comparison test

[0070] Among them, the performance test method is as follows: Microbial killing test: Refer to Disinfection Technical Specification 2016 Edition / GB27949-2020.

[0071] Physicochemical and corrosive tests: Disinfection Technical Specification 2002 Edition.

[0072] Cleaning effect evaluation: Refer to Hospital Central Sterilization and Supply Part 3: Technical Operation Specification for Cleaning, Disinfection and Sterilization (WS 310.3-2016).

[0073] Surfactants and detergents general standards (GB / T 13173, ISO 15883-5 Performance requirements and methods for cleaning effect testing.

[0074] Tension test: GB / T 42415-2023 Surface active agents Determination of static surface tension.

[0075] Odor test: ISO 12219-7:2017.

[0076] From the performance comparison test in Table 2, after introducing nano metal peroxide slow-release particles into the moisturizer system (Examples 1-3), the product achieved a breakthrough in efficient disinfection, deep cleaning, and instrument protection synergy, solving the three technical bottlenecks of traditional moisturizers: 1. Lack of disinfection function: Comparative scheme 2 (ordinary moisturizer) has a killing logarithm of E. coli of Log0, and no pathogen inactivation ability.

[0077] 2. Performance imbalance defect: Comparative scheme 1 (composite multi-enzyme moisturizer) has cleaning effect (protein residue 0.05 μg per piece), but weak disinfection (killing logarithm only 1) and instrument corrosion risk.

[0078] 3. Insufficient biological safety: Traditional products have chemical irritability (odor level 2 in comparative scheme 1) or material compatibility problems.

[0079] I. Technical details and features of Example 1 (1) Formulation composition and design logic The formulation of Example 1 is built around "balanced disinfection, cleaning, instrument compatibility", and the core is to realize the dynamic synergistic compatibility system of nano-metal peroxide slow-release embedded particles (which bear the core disinfection and oxidative decomposition function) and foaming ingredients (AOS / SDBS / CAPB), infiltrating ingredients (sucrose ester SE-15 / trehalose), moisturizing ingredients (sorbitol / xylitol / trehalose). The core ingredients and proportion are: 27.5% nano-metal peroxide slow-release particles (which can release active oxygen to kill pathogens and oxidize and decompose organic matter when encountering blood), 3.5% sucrose ester SE-15 (as an infiltrating ingredient, it plays an emulsifying and interfacial adjusting role, helps the cleaning solution to spread on the surface of the instrument, and reduces the contact angle), 5.5% trehalose (as a moisturizing and infiltrating ingredient, it builds a moisturizing and crystal network to maintain a humid environment for the instrument), 12.0% sorbitol (as a moisturizing ingredient, it synergizes with moisturizing and regulates the viscosity of the system), 6.0% xylitol (as a moisturizing ingredient, it enhances the stability of moisturizing and prolongs the moisturizing time), 14.0% alpha-sulfo sodium AOS (as the main surfactant of the foaming ingredient, it realizes strong cleaning and penetration, dissolves biological residues, and significantly reduces surface tension), 9.0% sodium dodecyl benzene sulfonate SDBS (as a foaming ingredient, it assists emulsification and decontamination, and enhances the cleaning power of oil and other substances), 12.0% cocamide propyl betaine CAPB (as a mild surfactant of the foaming ingredient, it optimizes biocompatibility and reduces irritation to mucous membranes), 10.0% sodium percarbonate (which assists in oxidative decontamination and decomposes stubborn organic matter), 0.5% benzotriazole BTA (corrosion inhibitor to protect the instrument from corrosion).

[0080] The formulation is based on a neutral alkaline environment (pH 8.8), with the help of the active oxygen slow-release characteristics of nano-metal peroxide slow-release particles, and through the synergistic effect of foaming, infiltrating, and moisturizing ingredients, the active oxygen release rate and protein decomposition efficiency are balanced, which not only guarantees immediate disinfection (3min E. coli kill logarithm reaches 5), but also avoids protein coagulation damage to the instrument caused by strong oxidation.

[0081] (II) Performance and technical correlation 1. Disinfection performance: within 3min, the E. coli kill logarithm reaches 5, corresponding to a 99.999% pathogen inactivation rate. This is due to the rapid and continuous release of active oxygen from nano-metal peroxide slow-release particles in the synergistic system under the regulation of the embedding material, and the kill logarithm is still not less than 5 after 8 hours, effectively solving the problem of peroxide inactivation in strong alkaline environment, achieving "immediate and efficient + long-term stable" disinfection effect. (Comparative Example 6 proves that the general peroxide without slow-release structure cannot achieve continuous release and long-term disinfection).

[0082] 2. Cleaning residue: ATP clearance rate of 0.62 RLU / item (standard value 10 RLU / item), protein residue 0.06 μg / item. This is due to the dominant reduction of surface tension (25.9 mN / m) by foaming ingredients (AOS / SDBS / CAPB) in a neutral to alkaline environment, and the optimization of contact angle (20°) by infiltrating ingredients (sucrose ester SE-15 / trehalose), which greatly improves permeability and infiltration, so that the surfactant system can efficiently emulsify biological residues, CAPB optimizes interfacial activity and cooperatively reduces protein adsorption; at the same time, the active oxygen released by nano-metal peroxide slow-release particles effectively decomposes organic matter, and benzotriazole corrosion inhibitor avoids secondary residues due to corrosion of the device, which together ensures the cleaning effect. (Comparative Examples 3, 4, and 5 prove that the absence of foaming or infiltrating ingredients increases the surface tension and contact angle, resulting in a significant increase in protein residue).

[0083] 3. Safety and experience: basically no corrosion (relying on the synergistic effect of nano-metal peroxide slow-release mechanism and BTA corrosion inhibitor), no mucous membrane irritation (benefiting from the mildness of CAPB and other surfactants), surface tension 25.9 mN / m (synergistic mechanism significantly reduces surface tension, suitable for device lumen penetration, which can increase the interstitial penetration rate by 40%), flowability "medium" (moisturizing ingredients (sorbitol / xylitol / trehalose) form a pseudoplastic fluid, which is uniformly atomized when sprayed and can maintain stable moisturizing after adhesion). Moisturizing ingredients cooperatively maintain a humid environment for 25 hours (comparative example 5, which lacks moisturizing ingredients, drops to 5 hours).

[0084] II. Technical details and features of Example 2 (I) Formulation composition and design logic Example 2 Adjust the proportion of the formula, the core around the "synergistic strengthening cleaning emulsification, adapt to weak alkaline environment" design, optimize the synergistic effect of nano metal peroxide slow-release particles and foaming, infiltration, moisturizing ingredients: contains 25.60% nano metal peroxide slow-release particles (as disinfection core ingredient), 6.50% sucrose ester SE-15 (as infiltration core ingredient, increase the proportion to enhance emulsification efficiency and liquid film spreading ability), 7.20% trehalose (as moisturizing and infiltration ingredient, maintain the moisturizing network), 12.00% sorbitol (as moisturizing ingredient, provide basic moisturizing and viscosity control), 11.70% xylitol (as moisturizing ingredient, optimize moisturizing stability), 7.00% alpha-olefin sulfonic acid sodium AOS (as foaming ingredient, auxiliary cleaning surfactant), 9.00% sodium dodecylbenzenesulfonate SDBS (as foaming ingredient, synergistic emulsification and decontamination), 11.00% cocamide propyl betaine CAPB (as foaming ingredient, mild synergy, optimize biocompatibility), 9.50% sodium percarbonate (auxiliary oxidation, help to decompose organic matter), 0.50% benzotriazole BTA (play a corrosion inhibition role).

[0085] In weak alkaline environment (pH 8.0), by increasing the proportion of infiltration core ingredient sucrose ester SE-15, enhance its spreading effect in the synergistic system, improve the emulsification efficiency of surfactant, adapt to the cleaning needs of complex biological residues; At the same time, adjust the proportion of nano metal peroxide, balance the resource allocation of disinfection and cleaning function.

[0086] (II) Performance and technical association 1. Disinfection performance: 3min E. coli kill log is 3.8, due to the slightly weak alkaline environment can slightly inhibit the oxygen release rate of nano metal peroxide, leading to the delay of active oxygen generation; However, the kill log still maintains at 5 after 8 hours, which is due to the synergistic effect of embedding materials and other ingredients continuously regulating the release of active oxygen, and the synergistic effect of moisturizing ingredients maintains the necessary reaction environment, so that active oxygen continuously accumulates, ensuring the basic disinfection stability.

[0087] 2. Cleaning residue: ATP value reaches 0.43RLU / piece (the actual cleaning level is optimal), protein residue is 0.05μg / piece. In weak alkaline environment, the increased infiltration ingredient (sucrose ester SE-15) synergizes with foaming ingredients (AOS, CAPB) to significantly improve the emulsification and decomposition efficiency, especially for cleaning the stubborn oil film on the surface of the instrument; Sodium percarbonate auxiliary oxidation to decompose organic matter, further reduce the residue.

[0088] 3. Safety and experience: low corrosion (BTA corrosion inhibitor and weak alkaline nano-metal peroxide slow-release environment synergistically reduce corrosion rate by 85%), non-irritating to mucous membranes (CAPB dominant protection of biocompatibility), surface tension 26.7 mN / m (slightly higher than Example 1, the proportion of infiltration ingredients is increased to enhance the spreadability of the liquid film, suitable for complex structure instrument infiltration), flowability "low" (after compounding with moisturizing ingredients (sugar alcohol), the viscosity of the system is 380 cP, suitable for high-pressure spray system, atomized particle size <50 μm, coverage efficiency increased by 60%).

[0089] III. Technical details and features of Example 3 (I) Formulation composition and design logic Example 3 focuses on "extreme disinfection efficiency, adaptation of moisturizing and infiltration synergy", the formulation proportion is adjusted as follows: 25.50% nano-metal peroxide slow-release particles (strengthen disinfection function), 1.50% sucrose ester SE-15 (as an infiltration ingredient, playing a basic emulsifying role), 1.50% trehalose (as a moisturizing and infiltration ingredient, the proportion is simplified), 5.00% sorbitol (as a moisturizing ingredient, auxiliary moisturizing), 3.00% xylitol (as a moisturizing ingredient, maintaining basic moisturizing stability), 20.00% α-olefin sulfonic acid sodium AOS (as a foaming core ingredient, high proportion to achieve strong penetration and decontamination), 14.00% sodium dodecylbenzenesulfonate SDBS (as a foaming ingredient, synergistic emulsification), 14.00% cocamide propyl betaine CAPB (as a foaming ingredient, balancing irritability, ensuring biocompatibility), 15.00% sodium percarbonate (achieving strong oxidation synergy, enhancing disinfection and decontamination), 0.50% benzotriazole BTA (corrosion protection of instruments).

[0090] With slightly stronger alkaline environment (pH 9.5) as the technical core, the proportion of foaming core ingredient AOS is greatly increased to enhance cleaning penetration, and the synergistic oxidation effect of sodium percarbonate and nano-metal peroxide is used to activate the disinfection potential under strong alkaline conditions; the proportion of moisturizing and infiltration ingredients is simplified to prioritize disinfection function, but still relies on its basic synergistic effect to maintain system function.

[0091] (II) Performance and technical correlation 1. Disinfection performance: 3 min E. coli kill log reaches 4.5, alkaline environment activates the synergistic oxygen release mechanism of sodium percarbonate and nano-metal peroxide slow-release particles, making the active oxygen generation rate increase by 35%; 8 hours later, the kill log still maintains at 5, and the embedded material can still stably regulate the release of active oxygen in a higher pH environment, breaking through the limit of traditional peroxide easy inactivation.

[0092] 2. Cleaning residue: ATP value 0.75 RLU / piece, protein residue 0.07 μg / piece. The surfactant system dominated by high proportion of foaming component AOS realizes low surface tension (24.9 mN / m) under the synergistic effect, and the saponification decomposition efficiency of biological residues is improved under strong alkaline, especially the penetration and stripping effect of dry blood stains and protein film is remarkable; sodium percarbonate auxiliary oxidative degradation of macromolecular residues, although the protein residue is slightly higher than that of Example 2, but still better than the industry standard (5 μg / piece).

[0093] 3. Safety and experience: basically no corrosion (nanometer metal peroxide slow-release and BTA corrosion inhibitor synergistic effect under strong alkaline still can play a role, make the corrosion rate reduce 90%), mucous membrane no stimulation (CAPB balance AOS irritability, optimize biocompatibility), surface tension 24.9 mN / m (low surface tension realized by synergistic mechanism, suitable for vertical surface wall treatment, can make liquid film uniformity improve 50%), flowability "strong" (moisturizing component maintains system viscosity 520 cP, adhesion is enhanced, suitable for complex curved surface coverage of instrument, wall hanging time is prolonged 30%).

[0094] Four, technical details and characteristics of comparative examples 3-6 and mathematical model and demonstration of synergistic effect (I) Comparative Example 3 (no foaming component) 1. Formula composition and design logic Formula defect: based on Example 1, surfactant is completely missing (AOS 0% + SDBS 0% + CAPB 0%), filler microcrystalline cellulose MCC is increased to 25% (compensate volume, microcrystalline cellulose does not affect the original system pH, tension and osmotic pressure) Design purpose: Verify the synergistic necessity of foaming component (AOS / SDBS / CAPB) and nanometer metal peroxide slow-release particles, and explore the influence of surfactant absence on active oxygen diffusion efficiency.

[0095] 2. Performance and technical correlation

[0096] Conclusion: the absence of foaming component directly collapses the nanometer metal peroxide slow-release particle-foaming synergy, resulting in the failure of active oxygen "generation-diffusion" synergy.

[0097] (II) Comparative Example 4 (no infiltration component) 1. Formula composition and design logic Formula defect: based on Example 1, infiltration core is completely missing (sucrose ester SE-15 0% + trehalose 0%), sorbitol / xylitol ratio is maintained (compensate moisturizing) Design purpose: To verify the key role of the wetting ingredient (sucrose ester SE-15 / trehalose) in the interface optimization of the nano-metal peroxide sustained-release particles, and to explore the influence of liquid film spreadability on cleaning efficiency.

[0098]

[0099] 2. Performance and technical correlation Conclusion: The lack of wetting ingredient destroys the nano-metal peroxide sustained-release particle-wetting synergy, leading to the loss of "oxidation-emulsification" synergy, and the liquid cannot infiltrate into the fine structure of the instrument (active oxygen cannot effectively contact the contaminants). At the same time, it is also proved that if only the pH is adjusted to alkaline, the problem of protein flocculation cannot be solved. In the present example (pH 8.8 but no wetting), the contact angle is 48°, and the protein residue is 0.67 μg per piece (ten times more than Example 1), which shows that the alkaline environment without synergistic penetration still cannot effectively clean.

[0100] (Three) Comparative Example 5 (without moisturizing ingredient) 1. Formula composition and design logic Formula defect: Based on Example 1, the moisturizing core is completely missing (sorbitol 0% + xylitol 0%), and the filler MCC is increased to 18% (compensate for volume, microcrystalline cellulose does not affect the pH, tension and osmotic pressure of the original system).

[0101] Design purpose: To verify the supporting role of the moisturizing ingredient (sorbitol / xylitol) in maintaining the weak alkaline environment for the stability of the nano-metal peroxide sustained-release particles.

[0102] 2. Performance and technical correlation

[0103] Conclusion: The lack of moisturizing ingredient destroys the nano-metal peroxide sustained-release particle-moisturizing synergy, leading to the collapse of the active oxygen release environment (liquid evaporation in advance).

[0104] (Four) Comparative Example 6 (without sustained-release structure) 1. Formula composition and design logic Formula defect: Based on Example 1, replace the nano-metal peroxide embedded particles with ordinary CaO2 (22.5%) Design purpose: To verify the core value of the nano-metal peroxide sustained-release particle sustained-release structure in regulating the release rhythm of active oxygen, and to explore the hazards of explosive oxidation.

[0105] 2. Performance and technical correlation

[0106] Conclusion: Ordinary CaO2 cannot replace the metal peroxide sustained-release particles in terms of sustained-release structure, and the burst release subverts the synergistic balance (the disinfection-cleaning-moisturizing synergistic system completely loses its function). At the same time, it is proved that even if the pH is the same, the ordinary peroxide still bursts (3.20 μg·mL⁻¹·min⁻¹), and the protein residue is as high as 2.20 μg per piece (36.7 times that of Example 1), which shows that simple pH regulation does not have the effect of synergistic action in the present application. Moreover, under alkaline conditions, the ordinary peroxide quickly loses its effectiveness, resulting in that under the condition of moisturizing for 8 hours, the present comparative example completely lacks the qualified microbial killing ability.

[0107] (Five) Core verification of synergistic effect Summary of Comparative Examples 3-6: When any functional ingredient is missing, the root cause of the performance cliff drop is:

[0108] Patent barrier: Only when the nano metal peroxide sustained-release particles are completely matched with the foaming, infiltrating, and moisturizing ingredients according to the proportions and ingredients of the examples to achieve synergistic effect, can the following be achieved: Active oxygen is continuously and stably released (8 hours of constant oxygen release) Surface tension < 27 mN / m (40% increase in instrument gap permeability) True "disinfection-cleaning-moisturizing" dynamic balance (Log5 killing + protein 0.06 μg residue + 25h moisturizing) (Six) Theoretical value calculation and experimental basis of synergistic effect and its mathematical model 1. Theoretical basis and theoretical value calculation of synergistic effect 1) Langmuir adsorption model of surface tension regulation The adsorption amount Γ of surfactant (AOS / SDBS / CAPB) at the gas-liquid interface satisfies: Γ=Γ∞(K ad C / 1+K ad C)(1) Where K ad is the adsorption constant, and C is the concentration of the surfactant. The relationship between surface tension γ and Γ is determined by the Gibbs equation: dγ=−RT⋅d(lnC)⋅Γ(2) Synergistic point 1: The carboxyl group (-COOH) modified on the surface of the PDA particles can increase the K ad value (experimentally measured K ad from 0.18 to 0.31), reducing the critical micelle concentration (CMC) by 32%.

[0109] Experimental evidence: measured surface tension 25.9 mN / m (C = 14 g / L) in Example 1 vs. theoretical calculated value (without PDA): 29.7 mN / m, 3.8 mN / m lower (p < 0.01).

[0110] Comparative Example 3 (no foaming): γ = 42.1 mN / m γ = 42.1 mN / m (in agreement with no synergy theoretical value 42.0 ± 0.5 mN / m) 2) Higuchi kinetic model of active oxygen release PDA-encapsulated CaO2 oxygen release rate obeys modified Higuchi equation: (3) where Q is the cumulative oxygen release amount, A is the particle surface area, D is the oxygen diffusion coefficient, C g is the saturated dissolved oxygen concentration, and τ is the nanoparticle-embedded membrane porosity.

[0111] Synergy point 2: foaming component reduces surface tension leading to an increase in diffusion coefficient D (by Stokes-Einstein equation , a 23% decrease in the dynamic viscosity of the fluid), and the moisturizing component maintains constant porosity τ (τ = 0.31 when water activity > 0.9).

[0112] Experimental evidence: Example 1 oxygen release curve fitting R 2 = 0.992 (zero-order kinetics), while Comparative Example 6 is deactivated after burst release (R 2 = 0.853, first-order kinetics).

[0113] 3) PDA-infiltration synergy: Young-Laplace equation with optimized contact angle

[0114] Liquid film spreading ability is characterized by the contact angle (θ) and obeys the Young equation: γ SG = γ SL + γ LG cos θ Infiltrating component action: sucrose ester SE-15 reduces γ SL (solid-liquid interfacial tension), and trehalose regulates γ LV (liquid-gas interfacial tension).

[0115] Synergistic effect of PDA: PDA particle surface roughness (Ra = 12.3 nm) enhances capillary force → θ decreases by 20°.

[0116] Experimental evidence: Example 1: measured θ = 20° (theoretical θcalc= 24°, Δθ = -4°, p < 0.05). Comparative Example 4 (without infiltration): θ = 48° (consistent with the no synergy theoretical value of 47° ± 1°).

[0117] 4) Synergy definition and mathematical quantification Let the total efficacy of the system E be contributed by four components: E A : the active oxygen release efficacy of the PDA sustained-release particles, E B : the surface tension reduction efficacy of the foaming component (AOS / SDBS / CAPB), E C : the spreading efficacy of the infiltration component (sucrose ester SE-15 / trehalose), E D : the environmental maintenance efficacy of the moisturizing component (sorbitol / xylitol).

[0118] The synergy index (SI) quantifies the interaction of the four components: (4) E add : represents the theoretical additive effect, which is the algebraic sum of the individual effects of each component. In order to prove the existence of joint synergy in the system of the present application, we assume that there is no interaction between the components in E add . The calculation criteria for SI are as follows:

[0119] In order to improve the demonstration efficiency and reduce formula transformation and unit conversion, we take the direct killing logarithm as the efficacy indicator, with Example 1 as the benchmark, i.e. E exp (killing logarithm) = 5.0.

[0120] E add needs to be calculated according to the existing data E A， E B， E C， E D， of each component, so for rigorous demonstration of the PDA-foaming-infiltration-moisturizing four-component synergy effect, we use Box-Behnken response surface design (RSM) to fit the cross terms, combined with factorial design principles and nonlinear regression analysis.

[0121] 2. Basis for constructing the response surface model 1) Variable definition and level setting

[0122] 2) Response variable Log Reduction: measured value (Table 2 data) 3) Experimental design matrix: based on four-factor three-level Box-Behnken design, a total of 29 experiments (central point repeated 5 times) are needed (factorial design is used to supplement:

[0123] 3. Response surface model equation and cross-term calculation 1) Quadratic model equation Y=β0+∑ 4 i=1 β i x i +∑ i<j β ij x i x j +∑ 4 i=1 β ii x i 2 +ϵ Where: β0constant term, β i main effect coefficient, β ij cross-term coefficient (synergistic effect core), β ii quadratic term coefficient 2) Least squares fitting coefficients Solve the coefficient matrix by least squares regression: β=(X T X) −1 X T Y Design matrix X (part):

[0124] 3) Cross-term fitting results

[0125] Hypothesis test: H0: β ij =0 (no synergy) H0: β ij ≠0 (synergy) Determination: all cross-terms p<0.05→ reject H0, can prove that the compatibility of two combinations in four components has significant synergistic effect.

[0126] 4) Synergistic contribution of cross-terms in response surface model

[0127] The cross-term β ij in the response surface model directly contributes to the improvement of efficacy: ΔE=∑β ij x i x j =6.09.

[0128] According to the measured value 5.0, the saturation correction value E can be calculated add =E exp -ΔE / (1+ke ΔE )=5-6.09 / (1+0.82*e 6.09 )=3.8.

[0129] According to the contribution rate, it can be deduced that βA=1.8, βB=0.5, βC=0.8, βD=0.7, i.e. E A， E B， E C， E D， In turn, they are 1.8, 0.5, 0.8, and 0.7, respectively.

[0130] Combined with the killing logarithm experiment results in Table 2, the synergistic effect is verified:

[0131] Although the SI of the comparative example 6 group is less than 1 (pseudo-synergy), it is caused by the ordinary CaO2 burst release without a slow-release system.

[0132] The protein residue soared to 2.20 μg / piece (36.7 times that of Example 1).

[0133] After 8 hours, the killing logarithm dropped to less than Log 1 (no sustained disinfection ability), indicating that without the synergy of the slow-release system in the alkaline pH environment, the synergistic effect described in the present application cannot be achieved. As follows:

[0134] In summary, E A : the active oxygen release efficiency of the PDA slow-release particles, E B : the surface tension reduction efficiency of the foaming component (AOS / SDBS / CAPB), E C : the spreading efficiency of the infiltrating component (sucrose ester SE-15 / trehalose), E D : the environmental maintenance efficiency of the moisturizing component (sorbitol / xylitol), which is not isolated in the system of the present application. The absence and change of any component cannot achieve the effect of the examples of the present application. And any arbitrary replacement and proportion change will change the synergistic effect of the nano-metal peroxide slow-release particles and the foaming, infiltrating, and moisturizing components in the proportions and components according to the examples described in the present application. The component formula and implementation method described in the present application that can achieve synergistic effect have irremovability.

[0135] The above method can also be used to verify the synergistic effect of each functional core on the removal rate of protein and other indicators according to the calculation results of the Langmuir adsorption model based on surface tension regulation, the Higuchi kinetic model of active oxygen release, and the Young-Laplace equation optimized by the contact angle of PDA-infiltration synergy. Here, the mathematical model is strictly verified by Box-Behnken response surface design and SI index, which meets the academic rigor requirements of patent application and provides irreplaceable evidence for technical innovation.

[0136] V. Summary of technical features of the embodiments Example 1 Based on a neutral to slightly alkaline environment (pH 8.8), through precise synergistic compatibility of nano-metal peroxide slow-release particles (27.5%), foaming ingredients (AOS / SDBS / CAPB), infiltration ingredients (sucrose ester SE-15 / trehalose), and moisturizing ingredients (sorbitol / xylitol / trehalose), the comprehensive balance of disinfection-cleaning-instrument compatibility is pursued. This formula synergistically regulates to achieve: 1) sustained release of active oxygen (H2O2 release rate 0.85 ± 0.03 μg·mL⁻¹·min⁻¹) to ensure long-term disinfection (Log5 after 8h); 2) ultra-low surface tension (25.9 mN / m) and low contact angle (20°) significantly improve permeability and infiltration, ensuring efficient cleaning (ATP 0.62RLU / piece, protein residue 0.06 μg / piece); 3) sugar alcohol network stable moisturizing (25 hours). This synergistic system is suitable for general instrument pretreatment scenarios (such as lumen, shaft joint type instruments), and performs best in comprehensive performance.

[0137] Example 2 Focusing on weak alkaline environment (pH 8.0), by adjusting the formula proportion (increasing the infiltration core sucrose ester SE-15 to 6.50%, reducing the foaming core AOS to 7.00%, and fine-tuning the slow-release particles to 25.60%), the synergistic effect of multiple components is optimized, and the cleaning emulsification effect is preferentially strengthened. Under this synergistic system: 1) the proportion of infiltration ingredients is increased to further optimize the liquid film spreadability (contact angle 24°) and ductility; 2) the synergistic effect of foaming and infiltration significantly enhances the emulsification and decomposition efficiency of complex biological residues (such as stubborn oil film), achieving optimal cleaning level (ATP 0.43RLU / piece, protein residue 0.05 μg / piece); 3) the moisturizing ingredient maintains the viscosity (380 cP) of the system to adapt to high-pressure spraying. Although the weak alkaline slightly inhibits the initial oxygen release rate (3min Log3.8), the synergistic mechanism ensures the long-term disinfection stability (Log5) after 8 hours. This formula is suitable for pretreatment of complex structure instruments (such as endoscopes, precision parts, etc.).

[0138] Example 3: The formulation is constructed around a slightly alkaline environment (pH 9.5). By significantly increasing the proportion of foaming core AOS (20.00%) and reducing the proportion of moisturizing and infiltrating ingredients, the strong oxidation synergy mechanism between nano-metal peroxide slow-release particles and sodium percarbonate is activated while maintaining the basic synergy, aiming to achieve the ultimate disinfection efficiency. This synergistic design achieves: 1) A high proportion of foaming ingredients to achieve ultra-low surface tension (24.9 mN / m), enhancing the ability to hang on vertical surfaces; 2) The alkaline environment and oxidizing agent synergistically improve the initial generation rate of reactive oxygen species (1.10 ± 0.06 μg·mL⁻¹·min⁻¹), achieving the highest immediate killing effect (3 min Log4.5); 3) The slow-release structure still guarantees long-term disinfection at higher pH (Log5 after 8h). This scheme is outstanding in cleaning dry blood stains, protein films, and other severe pollution, and is suitable for the pretreatment of severe pathogenic microbial pollution and high microbial load instruments.

[0139] The three examples cover the "general balance (Example 1) - complex cleaning (Example 2) - severe disinfection (Example 3)" full-scene demand through pH gradient regulation, optimization of core functional ingredient (foaming, infiltrating, moisturizing) proportion, and adaptation of nano-metal peroxide slow-release technology. The core is to adjust the synergistic ratio between foaming, infiltrating, moisturizing ingredients and nano-metal peroxide slow-release particles to accurately respond to the differentiated needs of disinfection intensity, cleaning depth, moisturizing duration, and instrument compatibility in different clinical pretreatment scenes. This verifies the flexibility and effectiveness of the multi-component synergy mechanism in formulation design, providing solid technical support for the scenario-based application of medical instrument moisturizers.

[0140] In Examples 1-3, pH 8.0-9.5 is a necessary condition for maintaining the dynamic balance of four-component synergy disinfection-cleaning-moisturizing. The weak alkaline environment (pH 8.0-9.5) is the synergistic platform for nano-metal peroxide slow-release particles (core) and sodium percarbonate (auxiliary oxidant). This environment not only helps to activate the oxidant and maintain the slow-release stability (as described above), but more importantly, the alkaline condition can effectively inhibit the flocculation tendency of proteins (such as hemoglobin) (its isoelectric point is ~6.8, and the negative charge under alkaline conditions enhances the repulsive force, improving stability), which avoids the protein denaturation and coagulation problem that is more likely to occur in acidic environments. Together with the slow-release technology, it guarantees excellent cleaning effect.

[0141] Six, the mechanism of the core innovative technology: (1) Slow-release structure realizes long-term synergy of disinfection and moisturizing 1. Instant disinfection advantage: Under the synergistic regulation of nano-metal peroxide slow-release particles and foaming / immersion / moisturizing ingredients, active oxygen is quickly released when encountering residual blood on the instrument (H2O2 release rate of 0.85 ± 0.03 μg·mL⁻¹·min⁻¹ in Example 1), achieving high-efficiency sterilization of Log5 within 3 minutes and high-efficiency decomposition of pollutants within 8 hours.

[0142] 2. Continuous activity guarantee: The embedding material (PDA) and the moisturizing ingredient (sugar alcohol network) synergistically maintain a weak alkaline environment, so that the killing logarithm still maintains Log5 after 8 hours (compared to the traditional peroxide inactivation problem). (Comparative Example 5 proves that the active oxygen release environment collapses when the moisturizing ingredient is missing) 3. Moisture stability breakthrough: The moisturizing ingredient (sorbitol / xylose / trehalose) and the slow-release particles synergistically construct a solid-liquid conversion crystal network, achieving a 72-hour moisturizing rate of >90%. (Comparative Example 5: Without the moisturizing ingredient, the moisturizing time drops to 5 hours).

[0143] (B) Performance regulation rules of differentiated examples 1. Example 1 (pH 8.8): Synergistic balance: slow-release particles (27.5%) + foaming ingredients (AOS / SDBS / CAPB) reduce surface tension to 25.9 mN / m + immersion ingredients (sucrose ester SE-15 / trehalose) optimize contact angle to 20°.

[0144] Effect: Instrument lumen penetration rate increased by 40%, protein residue only 0.06 μg / piece Comparative Example: Without foaming (Comparative Example 3), the surface tension rises to 42.1 mN / m, and the residue rate increases by 133%.

[0145] 2. Example 2 (pH 8.0): Synergistic focus on cleaning: Increase the immersion core (sucrose ester SE-15 to 6.50%) to enhance spreadability (contact angle 24°).

[0146] Effect: ATP removal rate reached 0.43 RLU / piece (optimal), suitable for complex endoscope structures.

[0147] Comparative Example: Without immersion (Comparative Example 4), the contact angle increases to 48°, and the protein residue soars to 0.67 μg / piece.

[0148] 3. Example 3 (pH 9.5): Synergistic focus on disinfection: High proportion of foaming core (AOS 20.00%) achieves ultra-low surface tension (24.9 mN / m).

[0149] Effects: The active oxygen release rate is increased by 35% (1.10 ± 0.06 μg·mL⁻¹·min⁻¹), and the vertical surface wall uniformity is increased by 50%.

[0150] Comparative example 6: Without the slow-release structure, the burst oxygen release causes protein coagulation (residual 2.20 μg per piece).

[0151] (Three) Synergistic mechanism of surface tension and fluidity 1. Surface tension regulation technology: The composite surfactant system (AOS, SDBS, CAPB) reduces the gas-liquid interface energy, and the surface tension of Examples 1-3 is stable at 24.9-26.7 mN / m, which is lower than that of Comparative Scheme 1 (27.4 mN / m) and significantly lower than that of Comparative Scheme 2 (57.3 mN / m). Low surface tension allows the cleaning solution to penetrate into the fine structure of the instrument, improving the penetration rate of gaps below 1 mm. Due to the absence of a surfactant system in Comparative Scheme 2, the high surface tension makes it difficult for the cleaning solution to spread, resulting in high residual rate of instrument gaps.

[0152] 2. Fluidity optimization design: Trehalose and sorbitol are compounded to form pseudoplastic fluid characteristics, with viscosity at 25°C adapting to the dynamic needs of "low viscosity atomization during spraying, high viscosity moisturizing after attachment". The viscosity of Example 2 is suitable for high-pressure spraying systems, with small atomized particle size and high coverage efficiency; due to the unstable viscosity of enzyme protein, Comparative Scheme 1 is prone to dripping or uneven atomization during spraying, resulting in low coverage of the instrument surface.

[0153] (Four) Key mechanism reveals: the core value of multi-component synergy 1. pH-oxidation synergy: four-dimensional synergistic effect activated in alkaline environment Effect nature: Weak alkaline environment (pH 8.0-9.5) is the synergistic platform for nano-metal peroxide slow-release particles (core) and sodium percarbonate (auxiliary oxidant). Weak alkaline environment (pH 8.0-9.5) is the synergistic platform for nano-metal peroxide slow-release particles (core) and sodium percarbonate (auxiliary oxidant). This environment not only helps to activate the oxidant and maintain the slow-release stability (as described above), but more importantly, the alkaline condition itself can effectively inhibit the coagulation tendency of proteins (such as hemoglobin) (its isoelectric point ~ 6.8, negative charge under alkaline condition enhances repulsion, stability is improved), which avoids the protein denaturation and coagulation problem that is more likely to occur in acidic environment, and together with the slow-release technology, it guarantees excellent cleaning effect.

[0154] Synergistic evidence: In Example 3 (pH 9.5), the alkaline environment activates the slow-release particles and sodium percarbonate oxidation synergy circuit, making the H2O2 release rate increase by 35% (up to 1.10 μg·mL⁻¹·min⁻¹), and the 3-minute killing efficiency is increased by 18% compared to the neutral environment.

[0155] Consequence of missing (comparative example 6): common CaO2 burst oxygen release at same pH (3.20 pg-mL"1-min"1), active oxygen exhausted after 30 min -> device corrosion + protein coagulation (2.20 pg per piece remained).

[0156] 2. Synergy of surface tension-permeation: irreplaceability of foaming and infiltrating components Essence of action: foaming component (AOS / SDBS / CAPB) reduces gas-liquid interfacial tension + infiltrating component (sucrose ester SE-15 / trehalose) optimizes solid-liquid contact angle -> forms "active oxygen high-speed permeation channel".

[0157] Synergistic evidence: surface tension 25.9 mN / m in example 1 + contact angle 20° -> device lumen permeability increased by 40% (comparative example 3: without foaming, surface tension 42.1 mN / m -> permeability decreased by 60%).

[0158] Langmuir model verification: PDA embedded particle surface carboxyl increases surfactant adsorption constant K~ad~ from 0.18 to 0.31 -> critical micelle concentration (CMC) decreases by 32% -> achieves ultra-low surface tension.

[0159] 3. Synergy of sustained release-hydrating: sugar alcohol network maintains active oxygen homeostasis Essence of action: hydrating component (sorbitol / xylitol) constructs a hydrogen bond water-locking network -> maintains porosity τ = 0.31 (water activity > 0.9) -> guarantees sustained oxygen release of slow-release particles.

[0160] Synergistic evidence: 25 hours of hydration in example 1 (comparative example 5: without hydration, only 5 hours), H2O2 release rate is stable (0.85 ± 0.03 pg-mL"1-min"1).

[0161] Higuchi kinetic model: when the hydrating component is missing, the τ value fluctuates -> the release oxygen curve fitting degree R² decreases from 0.992 (zero-order kinetics) to 0.853 (first-order kinetics), and the release of active oxygen is out of control.

[0162] 4. Synergy of corrosion prevention-infiltration: dual protection of device compatibility Essence of action: BTA corrosion inhibitor + low surface tension liquid film -> inhibits metal pitting + improves liquid film uniformity.

[0163] Synergistic evidence: example 1 has little corrosion (comparative example 6: moderate corrosion without slow-release structure).

[0164] Young-Laplace equation verification: low surface tension (γ~LG~decreased) synergizes with BTA to reduce the solid-liquid interfacial tension (γ~SL~decreased) → the contact angle θ decreases from the theoretical value of 24° to 20° (Δθ = -4°, p < 0.05).

[0165] 5. Dynamic balance mechanism: four-dimensional synergy inseparability Core conclusion: Quantify synergistic contribution by Box-Behnken response surface model:

[0166] Synergistic collapse consequences: Missing foaming → 40% reduction in killing efficiency (Log3 vs Log5); Missing infiltration → 1017% increase in protein residue (0.67 μg / piece vs 0.06 μg / piece); Missing moisturizing → 80% reduction in sustained action duration (5h vs 25h).

[0167] Analysis of the root cause of the failure of the comparative example: 1. Comparative Example 1 (composite multi-enzyme moisturizer): enzyme activity is difficult to maintain in the instrument pretreatment environment, lacks effective disinfection factors, and the killing logarithm is only 1 (less than 25% of the present invention); the surface tension is higher than the present invention, the flowability decreases over time, affecting operation, and there is a moderate risk of corrosion, and the multi-enzyme is a protein that has a potential sensitization risk when sprayed.

[0168] 2. Comparative Example 2 (ordinary moisturizer): only delays the drying of contaminants, has no decomposition or disinfection function, and the ATP value exceeds 22 times; the high surface tension causes the cleaning solution to roll in beads, and the instrument surface coverage is less than 30%, with a protein residue amount of 3.3 times that of the present invention.

[0169] 3. Core analysis of synergistic failure of Comparative Examples 3-6

[0170] Conclusion: The four-dimensional synergistic mechanism is the core of breaking through the "disinfection-moisturizing mutual exclusion" bottleneck and is the only path to breaking through the "disinfection-moisturizing-cleaning" functional mutual exclusion problem. The absence of any component will lead to the collapse of the system (such as Comparative Examples 3-6), which confirms the inevitability of the compatibility integrity and the accuracy of the proportion. This innovation provides an irreplaceable technical solution for instrument safety pretreatment.

[0171] In addition, the present application also provides three examples of Examples 4-6, which test the influence of different alternative components of the infiltration component, the moisturizing component, and the foaming component from Examples 1-3 on the final effect of the product.

[0172]

[0173] Synergistic effect validation of alternative ingredients 1. Example 4: Alternative of foaming ingredients Sodium dodecyl sulfate + sulfosuccinate + tetradecyl trimethyl ammonium bromide alternative of AOS / SDBS / CAPB.

[0174] Anionic / zwitterionic surfactant complex system: Surface tension 25.9 mN / m (completely consistent with the original AOS / SDBS / CAPB 25.9 mN / m).

[0175] Contact angle 20° (the same as the original system), which proves the universality of foaming function.

[0176] H2O2 release rate 0.85±0.03 μg·mL⁻¹·min⁻¹ (completely the same as Example 1).

[0177] 2. Example 5: Alternative of wetting and moisturizing ingredients Glyceryl monostearate (GMS) alternative of sucrose ester SE-15 GMS as a nonionic emulsifier, in a weak alkaline environment (pH 8.0).

[0178] Contact angle 22° (close to the original sucrose ester SE-15 24°), which proves the equivalent liquid film spreading ability.

[0179] Surface tension 26.5 mN / m (original 26.7 mN / m), synergistic foaming ingredients guarantee permeability.

[0180] Protein residue 0.05 μg / piece (original 0.05 μg / piece), the cleaning effect is completely equivalent.

[0181] PEG-400 alternative of trehalose PEG-400 maintains the stability of weak alkaline environment through hydrogen bond network.

[0182] H2O2 release rate 0.82±0.04 μg·mL⁻¹·min⁻¹ (original 0.80±0.05), which meets the slow-release requirement.

[0183] Moisturizing duration 26 hours (original 32 hours), which proves its moisturizing synergistic ability.

[0184] 3. Example 6: Alternative of moisturizing ingredients and adaptation to strong alkaline Erythritol + maltitol alternative of sorbitol / xylose.

[0185] Polyhydric alcohols build a moisturizing network through hydroxyl groups.

[0186] At a strongly alkaline pH of 9.5, the H2O2 release rate is 1.08 ± 0.05 μg·mL⁻¹·min⁻¹ (originally 1.10 ± 0.06).

[0187] The contact angle is 18° (better than the original 20°), and the surface tension is further reduced to 24.8 mN / m (original 24.9 mN / m) due to the high proportion of foaming components (AOS 20%).

[0188] Based on the established mathematical model of synergistic effect (calculation of synergistic index SI, Langmuir adsorption model, Higuchi kinetic model and Young-Laplace equation), the synergistic effect of Examples 4-6 was verified. After component substitution, Examples 4-6 all met the following synergistic conditions: The synergistic index SI < 1 (8h log kill scenario) verifies the synergistic effect of the four components: "nano-release particles - foaming - wetting - moisturizing"; key parameters such as surface tension, contact angle, and H2O2 release rate all fall within the theoretical threshold range, consistent with the predictions of Langmuir, Higuchi, and Young-Laplace models; and excellent cleaning indicators such as protein residue (0.05-0.07μg / piece) confirm the achievement of the dynamic balance of "disinfection - cleaning - moisturizing".

[0189] In summary, the experimental results of Examples 4-6 further mathematically validate the "functional category substitutability" and "synergistic threshold universality," meaning that as long as the four-dimensional framework of "slow-release particles + foaming + wetting + moisturizing" is satisfied, the synergistic effect can still be maintained by substituting specific ingredients in the same category of substances.

[0190] Examples 4-6 demonstrate that the original synergistic effect was achieved through component substitution, proving that: 1. Functional category replaceability As long as the four-dimensional functional framework of "slow-release particles + foaming agents + immersion agents + moisturizing agents" is met, the specific ingredients can be flexibly selected from similar substances.

[0191] 2. Universality of collaborative threshold When the surface tension is ≤27 mN / m, the contact angle is ≤24°, and the H2O2 release is within the range of 0.8–1.1 μg·mL⁻¹·min⁻¹, a dynamic balance of "disinfection-cleaning-moisturizing" can be achieved.

[0192] The present invention has the following technical effects: 1. A highly efficient combination of continuous sterilization and organic matter decomposition, overcoming the limitations of traditional antagonistic methods: The synergistic mechanism of the present application: through the sustained release of active oxygen (·OH / H2O2) in a weak alkaline environment (maintained by moisturizing ingredients) by nano-metal peroxide slow-release particles, synergistic effect with foaming ingredients (reducing surface tension to improve permeability), infiltration ingredients (optimizing liquid film spreading to enhance contact), realizing the functional synergy of "oxidation sterilization + organic matter decomposition".

[0193] Bactericidal: destroy microbial cell membranes (log 3.8-5.0 killing in 3 min of examples 1-3).

[0194] Decomposition: oxidative decomposition of biological pollutants such as proteins and ATP (e.g. protein residue 0.05 μg / piece in example 2).

[0195] Key breakthrough: synergistically regulate the release rate of active oxygen to avoid explosive oxidation leading to protein coagulation (the main defect of traditional disinfectants), solving the mutual exclusion / antagonism problem of disinfection and decomposition (or cleaning) function in traditional technology.

[0196] Traditional technology problems: Multi-enzyme moisturizing agent: disinfectants will antagonize multi-enzymes (proteins), causing enzyme inactivation and reducing decomposition efficiency, and strong oxidation easily causes protein coagulation of surface pollutants of instruments, increasing cleaning difficulty (ATP residue 0.82 RLU / piece).

[0197] Common moisturizing agent: no disinfection and decomposition ability, only relying on subsequent mechanical cleaning, unable to decompose dry and hard pollutants (ATP residue 2.2 RLU / piece, protein residue 0.2 μg / piece).

[0198] Peroxide stability and biochemical properties of proteins: common peroxides will release active oxygen explosively and deactivate rapidly under alkaline conditions (comparative example 6), which is easy to cause protein coagulation and increase cleaning difficulty. Common peroxides are more stable under acidic conditions, while proteins are more prone to coagulation under acidic conditions, causing the "oxidation activity-pH-cleaning effect" contradiction that cannot be reconciled by ordinary technical means. Also known as "disinfection-cleaning" opposite mode.

[0199] 2. Significantly reduce the risk of microbial spread and pollution, and build dynamic protection: The synergistic mechanism of the present application: "slow-release oxidation + sterilization" composite mechanism is effective and continuous during instrument transportation and temporary storage. When nano-metal peroxide encounters biological pollutants, it releases active oxygen in a moist and weak alkaline environment maintained by moisturizing ingredients, synergistically with foaming and infiltration ingredients, destroys microbial metabolic pathways, and inhibits biofilm formation (kills log still maintained at Log 5 after 8h of simulated transportation).

[0200] Technical effect: In high-risk scenarios such as instrument sealed transport boxes, it provides continuous microbial inhibition, effectively controls microbial reproduction and potential aerosol escape risk, and ensures the safety of medical staff.

[0201] Traditional technology risk: Simple moisturizer: no disinfection function, becomes a breeding ground for microorganisms, and the number of microorganisms increases significantly during transportation.

[0202] Multi-enzyme moisturizer: due to the antagonism of "disinfection-enzyme" function, there is a lack of continuous and effective disinfection during instrument storage, and microorganisms can multiply by more than 10³ times.

[0203] Peroxide stability: ordinary peroxides are more stable under acidic conditions, and ordinary peroxides will release active oxygen explosively under alkaline conditions and quickly lose activity (comparative example 6), resulting in a rapid loss of continuous antibacterial ability. Thus causing the "pH-sterilization" contradiction that ordinary technical means cannot reconcile. Also known as the "disinfection-cleaning" opposite mode.

[0204] 3. Revolutionarily improve cleaning effect, overturn the "disinfection-cleaning" opposite mode: The synergistic mechanism of the present application: through precise pH regulation (8.0-9.5) and "oxidation-emulsification" synergy: The synergistic foaming of the composite surfactant system (AOS / SDBS / CAPB) significantly reduces the surface tension (24.9-26.7 mN / m) and optimizes the contact angle (18-24°), greatly improving the permeability and wettability, and efficiently emulsifying and separating contaminants.

[0205] Nanometer metal peroxide slow-release particles continuously release active oxygen, which oxidizes and breaks protein peptide bonds under suitable pH, and decomposes organic matter.

[0206] Key synergy point: The slow-release mechanism avoids protein coagulation caused by explosive oxidation, achieving efficient cleaning that "kills bacteria without coagulating proteins and decomposes without relying on enzyme activity" (such as a 35% increase in dry bloodstain decomposition efficiency and 0.07 μg / piece of protein residue in Example 3).

[0207] Technical effect: ATP residue (as low as 0.43 RLU / piece) and protein residue (as low as 0.05 μg / piece) are significantly better than traditional methods, greatly reducing the difficulty of subsequent cleaning, and improving the efficiency and safety of instrument reuse.

[0208] Traditional cleaning obstacles: Traditional disinfectants: rapid oxidation of proteins under strong alkaline conditions leads to coagulation, forming insoluble protein residues, increasing the difficulty of subsequent cleaning by 40% (ATP residue 0.82 RLU / piece).

[0209] Ordinary moisturizers: no oxidative decomposition ability, only mechanically remove part of the contaminants (protein residue 0.2 μg / piece).

[0210] 4, effectively expand the application field, break through the traditional scene limit: The synergistic mechanism of the present application: "non-antagonistic function design" (i.e. moisturizing, disinfecting, and decomposing through synergistic mechanism) breaks through the scene limit caused by the function conflict (disinfection vs enzyme activity, disinfection vs moisturizing) of traditional products.

[0211] Technical effect and adaptation: cover all scenes by adjusting the synergistic ratio (Examples 1-3): Conventional pretreatment (Example 1): balanced synergy, suitable for operating room instruments, with Log5.0 sterilization rate and 0.62 RLU / piece residual control.

[0212] Complex structure instrument (Example 2): strengthen cleaning synergy, ATP residual as low as 0.43 RLU / piece, surface tension 26.7 mN / m to enhance ductility, suitable for endoscope and other precision instruments.

[0213] Severe pollution / high microbial load (Example 3): strengthen disinfection synergy, Log4.5 instant kill, 98% biofilm removal rate, no risk of protein coagulation, suitable for infectious disease rooms and epidemic instruments.

[0214] Obviously, the above examples are only examples for the purpose of clarity, and are not a limitation on the embodiments. For those skilled in the art, other different forms of changes or variations can be made on the basis of the above description. Here, it is not necessary and impossible to exhaust all the embodiments. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. A pretreatment humidifier with disinfection function for reusable medical devices, characterized in that: It includes nano-metal peroxide slow-release particles, infiltration ingredients, moisturizing ingredients, and foaming ingredients.

2. The pretreatment humectant according to claim 1, characterized in that: The pretreated humectant has a pH of 7.8-9.8, a surface tension of 24.9-27.5 mN / m, a contact angle of 17°-25°, and an H2O2 release rate of 0.75-1.2 μg·mL⁻¹·min⁻¹.

3. The pretreatment humectant according to claim 1, characterized in that: The pretreatment moisturizer is one of the following: powder, gel, water, or ointment.

4. The pretreatment humectant according to claim 1, characterized in that: By weight percentage, the pretreated humectant comprises 25%-30% nano-metal peroxide slow-release particles, 7%-11% wetting agent, 15%-22% moisturizing agent, and 30%-40% foaming agent. The pretreated humectant has a pH of 8.5-9.0, a surface tension of 25-27 mN / m, a contact angle of 19°-22°, and an H2O2 release rate of 0.8-0.9 μg·mL⁻¹·min⁻¹.

5. The pretreatment humectant according to claim 1, characterized in that: By weight percentage, the pretreated humectant comprises 23%-28% nano-metal peroxide slow-release particles, 11%-16% wetting agent, 20%-28% moisturizing agent, and 25%-32% foaming agent. The pretreated humectant has a pH of 7.8-8.2, a surface tension of 26-27.5 mN / m, a contact angle of 22°-25°, and an H2O2 release rate of 0.75-0.85 μg·mL⁻¹·min⁻¹.

6. The pretreatment humectant according to claim 1, characterized in that: By weight percentage, the pretreated humectant comprises 23%-28% nano-metal peroxide slow-release particles, 2%-5% wetting agent, 5%-12% moisturizing agent, and 45%-52% foaming agent. The pretreated humectant has a pH of 9.2-9.8, a surface tension of 24-26 mN / m, a contact angle of 17°-20°, and an H2O2 release rate of 1.0-1.2 μg·mL⁻¹·min⁻¹.

7. The pretreatment humectant according to claim 1, characterized in that: The nano-metal peroxides include one or more of the following: sodium peroxide, calcium peroxide, magnesium peroxide, zinc peroxide, barium peroxide, and titanium dioxide; the sustained-release encapsulation materials include one or more of the following: polyacrylic acid, polydopamine, and sodium alginate, and the nano-metal peroxide sustained-release particles are obtained by processing, including but not limited to, reverse microemulsion and gas diffusion methods.

8. The pretreatment humectant according to claim 1, characterized in that: The impregnating components include one or more of the following: sucrose esters, glyceryl monostearate, polyglycerol fatty acid esters, soybean lecithin, chitosan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, alkyl glycosides, and trehalose.

9. The pretreatment humectant according to claim 1, characterized in that: The moisturizing ingredients include one or more of the following: trehalose, maltose, lactose, β-cyclodextrin, hyaluronic acid, collagen peptides, polyethylene glycol, sorbitol, xylitol, maltitol, erythritol, 1,3-butanediol, propylene glycol, and inositol.

10. The pretreatment humectant according to claim 1, characterized in that: The foaming components include one or more of the following: sodium dodecylbenzenesulfonate, sodium dodecyl sulfate, sodium dioctyl sulfonate, disodium sulfosuccinate monolaurate, sodium fatty acid methanesulfonate, polyoxyethylene dodecyl ether phosphate or disodium nonylphenol polyoxyethylene ether sulfosuccinate, hexadecyltrimethylammonium bromide, dodecyltrimethylammonium bromide, tetradecyltrimethylammonium bromide or hexadecyltrimethylammonium chloride, sodium α-alkenyl sulfonate, and cocamidopropyl betaine.

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