A disinfectant for medical instruments, a method for preparing the same, and a method for using the same

Abstract

The application belongs to the technical field of medical instrument disinfection and relates to a disinfectant for medical instruments, a preparation method and a use method, which comprises the following steps: dispersing aminosilica mesoporous silica in deionized water, obtaining a dispersion liquid after ultrasonic dispersion, adding carboxymethyl chitosan sodium salt to the dispersion liquid, performing a first stirring and heating reaction, then adding polyhexamethylene biguanide hydrochloride, performing a second stirring and heating reaction, and obtaining a carrier bacteriostatic solution; adding benzalkonium chloride, epsilon-polylysine, ethylenediaminetetraacetic acid disodium salt and polyvinylpyrrolidone K30 in deionized water, uniformly mixing and stirring to obtain a synergistic bacteriostatic solution; under stirring, adding the carrier bacteriostatic solution into the synergistic bacteriostatic solution, uniformly mixing, adjusting the pH value, and obtaining the disinfectant for medical instruments. The disinfectant prepared by the application has the advantages of broad-spectrum antibacterial and long-acting bacteriostatic, and the comprehensive performance is better than that of a simple physical mixing type disinfectant.

Description

Technical Field

[0001] This invention belongs to the field of medical device disinfection technology, and relates to a disinfectant for medical devices, its preparation method and usage method. Background Technology

[0002] In the field of medical device disinfection and sterilization, the choice of disinfectant directly affects medical safety, device lifespan, and patient health. Currently commonly used clinical disinfectants, such as chlorine-based, aldehyde, and alcohol-based disinfectants, while possessing certain bactericidal effects, generally suffer from strong irritating odors, corrosiveness to medical devices, potential for toxic residues, or environmental impact. In recent years, novel disinfectant components, represented by quaternary ammonium salts, biguanides, and bio-derived molecules, have attracted attention due to their broad-spectrum antibacterial properties and relatively good safety profiles. However, disinfectants with single active ingredients are prone to inducing microbial resistance, and their effects are often limited, with limited effectiveness against complex biofilms.

[0003] To overcome the shortcomings of single-component formulations, combining multiple components with different bactericidal mechanisms has become an important research direction. However, simple physical mixing often faces challenges: components with different charge properties may flocculate or precipitate in solution, leading to poor physical stability of the formulation and inactivation of the active ingredient; in addition, most liquid disinfectants have the disadvantages of short action time and easy loss, making it difficult to form a long-lasting protective layer on the surface of instruments.

[0004] Therefore, developing a disinfectant that can stably load multiple bactericidal components, achieve synergistic effects, and prolong the duration of action is an urgent technical problem to be solved. Summary of the Invention

[0005] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a disinfectant for medical devices, its preparation method and application method. The disinfectant prepared has the advantages of broad-spectrum antibacterial and long-lasting bacteriostatic properties, and its comprehensive performance is superior to that of simple physical mixed disinfectants.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a method for preparing a disinfectant for medical devices, the method comprising:

[0008] (I) Aminated mesoporous silica is dispersed in deionized water and ultrasonically dispersed to obtain a dispersion. Sodium carboxymethyl chitosan is added to the dispersion and a first stirring and heating reaction is carried out. Then, polyhexamethylene biguanide hydrochloride is added and a second stirring and heating reaction is carried out to obtain a carrier antibacterial solution.

[0009] (II) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution;

[0010] (III) Under stirring conditions, the carrier antibacterial solution is added to the enhanced antibacterial solution, mixed evenly, and the pH value is adjusted to obtain the disinfectant for medical devices.

[0011] This invention uses aminated mesoporous silica as a sustained-release carrier, loading sodium carboxymethyl chitosan and polyhexamethylene biguanide hydrochloride (PHMB) through electrostatic interactions, and utilizing polyvinylpyrrolidone K30 as a stabilizer. This effectively prevents flocculation and precipitation when antibacterial components with different charges are mixed, ensuring the dispersion stability of the disinfectant. Furthermore, the bactericidal disinfection system designed in this invention includes a long-acting antibacterial component and an immediate bactericidal component. The long-acting antibacterial component is aminated mesoporous silica loaded with PHMB, while the immediate bactericidal component includes benzalkonium chloride and ε-polylysine. Additionally, the metal chelating agent disodium EDTA is added to enhance the penetration of the bactericidal components into biofilms and bacterial outer membranes. This results in a disinfectant that combines broad-spectrum antibacterial activity with long-acting antibacterial action, exhibiting superior overall performance compared to simple physical mixture disinfectants.

[0012] This invention involves adding sodium carboxymethyl chitosan to an aminated mesoporous silica dispersion. Utilizing the electrostatic attraction between the positively charged aminated mesoporous silica and the negatively charged sodium carboxymethyl chitosan, the sodium carboxymethyl chitosan adsorbs onto the surface of the aminated mesoporous silica, forming a coating layer. Through electrostatic repulsion and steric hindrance, the uniformity of the aminated mesoporous silica dispersion in water is enhanced. Subsequently, PHMB, a cationic polymer bactericide, is added. PHMB further interacts with the negatively charged groups on the sodium carboxymethyl chitosan, resulting in its firm adsorption onto the surface of the coating layer. This effectively solves the problems of short action time and easy loss of liquid disinfectants. During use, it allows for the slow release of antibacterial components, providing long-lasting antibacterial capabilities and extending the effective protection time of medical device surfaces.

[0013] In the synergistic antibacterial solution, benzalkonium chloride, as a quaternary ammonium salt surfactant, inserts its hydrophobic chain into and disrupts the integrity of the cell membrane phospholipid bilayer, leading to intracellular leakage. ε-Polylysine, as a cationic polypeptide, binds to macromolecules on the bacterial cell membrane surface through multiple positively charged sites, forming transmembrane pores and subsequently causing bacterial cell membrane disintegration. Disodium EDTA, as a metal ion chelating agent, can disrupt membrane structure integrity by chelating metal ions in the bacterial cell wall. Based on this, benzalkonium chloride and ε-Polylysine can more effectively synergistically act on microorganisms protected by biofilms, improving the removal effect on complex biofilms. Polyvinylpyrrolidone K30, as a stabilizer and dispersant, uses its long-chain molecules to exert steric hindrance, preventing flocculation and precipitation due to charge neutralization when the carrier antibacterial solution and the synergistic antibacterial solution are mixed, ensuring the storage stability of the disinfectant.

[0014] As a preferred technical solution of the present invention, in step (I), the aminated mesoporous silica is prepared by the following method:

[0015] Mesoporous silica was dispersed in anhydrous ethanol and ultrasonically dispersed to obtain a suspension. Under nitrogen atmosphere and stirring conditions, 3-aminopropyltriethoxysilane was added dropwise to the suspension and refluxed. After the reaction was completed, the aminated mesoporous silica was obtained by centrifugation, washing and drying.

[0016] This invention uses 3-aminopropyltriethoxysilane (APTES) for amino modification. Amino groups are grafted onto the surface of mesoporous silica. In aqueous solution, the amino groups can be protonated to form positively charged ammonium ions, thereby making the entire material surface positively charged. Negatively charged sodium carboxymethyl chitosan is adsorbed onto the surface of the positively charged aminated mesoporous silica through electrostatic interaction, achieving a stable combination of the two and forming a coating structure.

[0017] The reflux reaction in anhydrous ethanol is primarily to suppress the formation of oligomer precipitates, a byproduct of the reaction, thereby preventing them from clogging the pore structure of mesoporous silica. If the water content in the reaction solution is too high, the ethoxy groups of APTES will rapidly undergo uncontrolled hydrolysis, generating a large amount of highly reactive silanols. These silanol molecules readily condense to form oligomer precipitates, which deposit on the surface of mesoporous silica, clogging the pore structure and significantly reducing the effective loading area of ​​the mesoporous silica. Using anhydrous ethanol as the reaction solvent allows the water content during the reaction to be controlled to extremely low levels. The water required for the hydrolysis of APTES comes only from the hydroxyl groups on the surface of mesoporous silica and trace amounts of ambient moisture, thus inhibiting the rapid hydrolysis of PATES and preventing the formation of oligomer precipitates.

[0018] As a preferred embodiment of the present invention, the average pore size of the mesoporous silica is 5~10nm, for example, it can be 5.0nm, 5.5nm, 6.0nm, 6.5nm, 7.0nm, 7.5nm, 8.0nm, 8.5nm, 9.0nm, 9.5nm or 10.0nm, but is not limited to the listed values, other unlisted values ​​within this range are also applicable.

[0019] In some optional instances, the average diameter of the mesoporous silica is 100 to 200 nm, for example, it can be 100 nm, 110 nm, 120 nm, 130 nm, 140 nm, 150 nm, 160 nm, 170 nm, 180 nm, 190 nm or 200 nm, but is not limited to the listed values, other unlisted values ​​within this range are also applicable.

[0020] In some optional instances, the mass fraction of mesoporous silica in the suspension is 1 to 3 wt%, for example, it may be 1.0 wt%, 1.2 wt%, 1.4 wt%, 1.6 wt%, 1.8 wt%, 2.0 wt%, 2.2 wt%, 2.4 wt%, 2.6 wt%, 2.8 wt%, or 3.0 wt%, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0021] In some alternative examples, the mass ratio of the mesoporous silica to 3-aminopropyltriethoxysilane is 1:(0.15~0.25), for example, it can be 1:0.15, 1:0.16, 1:0.17, 1:0.18, 1:0.19, 1:0.2, 1:0.21, 1:0.22, 1:0.23, 1:0.24 or 1:0.25, but is not limited to the listed values, other unlisted values ​​within this range are also applicable.

[0022] This invention specifically limits the mass ratio of mesoporous silica to APTES to 1:(0.15~0.25), effectively avoiding side reactions and oligomer formation caused by excessive silane. When the amount of APTES is too low, it cannot completely cover all the silanol groups on the surface of mesoporous silica, resulting in a low grafting rate and insufficient amination degree of APTES, which in turn affects its subsequent electrostatic bonding with negatively charged sodium carboxymethyl chitosan. When the amount of APTES is too high, the excess APTES cannot be grafted onto the surface of mesoporous silica, and the free APTES will undergo its own hydrolysis and condensation to form oligomer precipitates, blocking the pore structure of mesoporous silica and significantly reducing its specific surface area.

[0023] In some alternative instances, the reflux reaction temperature is 75 to 85°C, for example, 75°C, 76°C, 77°C, 78°C, 79°C, 80°C, 81°C, 82°C, 83°C, 84°C, or 85°C, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0024] In some optional instances, the reflux reaction time is 6 to 12 hours, for example, 6.0 hours, 6.5 hours, 7.0 hours, 7.5 hours, 8.0 hours, 8.5 hours, 9.0 hours, 9.5 hours, 10.0 hours, 10.5 hours, 11.0 hours, 11.5 hours, or 12.0 hours, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0025] In some optional instances, the centrifugation speed is 3000 to 5000 rpm, for example, it can be 3000 rpm, 3200 rpm, 3400 rpm, 3600 rpm, 3800 rpm, 4000 rpm, 4200 rpm, 4400 rpm, 4600 rpm, 4800 rpm or 5000 rpm, but is not limited to the listed values, other unlisted values ​​within this range are also applicable.

[0026] In some optional instances, the centrifugation time is 5 to 10 minutes, for example, 5.0 minutes, 5.5 minutes, 6.0 minutes, 6.5 minutes, 7.0 minutes, 7.5 minutes, 8.0 minutes, 8.5 minutes, 9.0 minutes, 9.5 minutes, or 10.0 minutes, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0027] In some alternative instances, the drying temperature is 60 to 80°C, for example, 60°C, 62°C, 64°C, 66°C, 68°C, 70°C, 72°C, 74°C, 76°C, 78°C or 80°C, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0028] In some optional instances, the drying time is 6 to 12 hours, for example, 6.0 hours, 6.5 hours, 7.0 hours, 7.5 hours, 8.0 hours, 8.5 hours, 9.0 hours, 9.5 hours, 10.0 hours, 10.5 hours, 11.0 hours, 11.5 hours, or 12.0 hours, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0029] As a preferred technical solution of the present invention, in step (I), the mass fraction of aminated mesoporous silica in the dispersion is 1~3wt%, for example, it can be 1.0wt%, 1.2wt%, 1.4wt%, 1.6wt%, 1.8wt%, 2.0wt%, 2.2wt%, 2.4wt%, 2.6wt%, 2.8wt%, or 3.0wt%, but it is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0030] In some optional instances, the ultrasonic power of the ultrasonic dispersion is 300 to 500 W, for example, 300 W, 320 W, 340 W, 360 W, 380 W, 400 W, 420 W, 440 W, 460 W, 480 W or 500 W, but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0031] In some optional instances, the ultrasonic dispersion time is 10 to 20 minutes, for example, 10 minutes, 11 minutes, 12 minutes, 13 minutes, 14 minutes, 15 minutes, 16 minutes, 17 minutes, 18 minutes, 19 minutes or 20 minutes, but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0032] As a preferred technical solution of the present invention, in step (I), the mass ratio of the aminated mesoporous silica to the sodium carboxymethyl chitosan salt is 1:(1~1.5), for example, it can be 1:1.0, 1:1.05, 1:1.1, 1:1.15, 1:1.2, 1:1.25, 1:1.3, 1:1.35, 1:1.4, 1:1.45 or 1:1.5, but it is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0033] This invention specifically specifies a mass ratio of aminated mesoporous silica to sodium carboxymethyl chitosan salt of 1:(1~1.5), which enables the formation of a complete and stable sodium carboxymethyl chitosan salt coating layer on the surface of aminated mesoporous silica. If the amount of sodium carboxymethyl chitosan salt is too low, the coating on the surface of aminated mesoporous silica will be uneven, affecting its stable dispersion in water and also affecting the subsequent electrostatic bonding between PHMB and sodium carboxymethyl chitosan salt, ultimately affecting the PHMB loading rate. If the amount of sodium carboxymethyl chitosan salt is too high, the excess sodium carboxymethyl chitosan salt cannot be completely fixed on the surface of aminated mesoporous silica through electrostatic interaction, and the free sodium carboxymethyl chitosan salt will interfere with the subsequent adsorption of PHMB.

[0034] In some alternative instances, the temperature of the first stirring and heating reaction is 40 to 50°C, for example, 40°C, 41°C, 42°C, 43°C, 44°C, 45°C, 46°C, 47°C, 48°C, 49°C or 50°C, but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0035] In some alternative instances, the first stirring and heating reaction time is 2 to 4 hours, for example, 2.0 hours, 2.2 hours, 2.4 hours, 2.6 hours, 2.8 hours, 3.0 hours, 3.2 hours, 3.4 hours, 3.6 hours, 3.8 hours, or 4.0 hours, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0036] In some optional instances, the rotational speed of the first stirring and heating reaction is 300 to 500 rpm, for example, 300 rpm, 320 rpm, 340 rpm, 360 rpm, 380 rpm, 400 rpm, 420 rpm, 440 rpm, 460 rpm, 480 rpm or 500 rpm, but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0037] Positively charged aminated mesoporous silica combines with negatively charged sodium carboxymethyl chitosan through electrostatic interactions, forming a hydrophilic, negatively charged coating layer on the carrier surface. This greatly enhances the dispersibility and compatibility of silica in aqueous solution. At the same time, the negatively charged groups such as carboxyl groups on its molecular chain also provide a large number of electrostatic interaction sites for the subsequent adsorption of PHMB.

[0038] As a preferred technical solution of the present invention, in step (I), the mass ratio of the polyhexamethylene biguanide hydrochloride to the sodium carboxymethyl chitosan salt is (0.4~0.5):1, for example, it can be 0.4:1, 0.41:1, 0.42:1, 0.43:1, 0.44:1, 0.45:1, 0.46:1, 0.47:1, 0.48:1, 0.49:1 or 0.5:1, but it is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0039] This invention specifically specifies a mass ratio of polyhexamethylene biguanide hydrochloride to sodium carboxymethyl chitosan (PHMB) of (0.4~0.5):1, thereby ensuring a uniform and stable loading of PHMB on the silica carrier. If the amount of PHMB used is too low, the negatively charged binding sites provided by the sodium carboxymethyl chitosan coating layer cannot be fully utilized, resulting in an insufficient PHMB loading and failing to achieve an effective antibacterial concentration, thus affecting the long-lasting antibacterial ability of the disinfectant. If the amount of PHMB used is too high, the excess PHMB cannot be fully and firmly bound to the carrier through electrostatic interactions, and the free PHMB is prone to flocculation in the solution, affecting the stability of the product.

[0040] In some alternative instances, the temperature of the second stirring and heating reaction is 40 to 50°C, for example, 40°C, 41°C, 42°C, 43°C, 44°C, 45°C, 46°C, 47°C, 48°C, 49°C or 50°C, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0041] In some alternative examples, the second stirring and heating reaction time is 1 to 2 hours, for example, 1.0 hours, 1.1 hours, 1.2 hours, 1.3 hours, 1.4 hours, 1.5 hours, 1.6 hours, 1.7 hours, 1.8 hours, 1.9 hours, or 2.0 hours, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0042] In some optional instances, the second stirring and heating reaction is carried out at a speed of 300 to 500 rpm, for example, 300 rpm, 320 rpm, 340 rpm, 360 rpm, 380 rpm, 400 rpm, 420 rpm, 440 rpm, 460 rpm, 480 rpm or 500 rpm, but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0043] As a preferred technical solution of the present invention, in step (II), the mass fraction of benzalkonium chloride in the synergistic antibacterial solution is 0.15~0.2wt%, for example, it can be 0.15wt%, 0.155wt%, 0.16wt%, 0.165wt%, 0.17wt%, 0.175wt%, 0.18wt%, 0.185wt%, 0.19wt%, 0.195wt%, or 0.2wt%, but it is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0044] In some optional instances, the mass fraction of ε-polylysine in the synergistic antibacterial solution is 0.03 to 0.08 wt%, for example, it may be 0.03 wt%, 0.035 wt%, 0.04 wt%, 0.045 wt%, 0.05 wt%, 0.055 wt%, 0.06 wt%, 0.065 wt%, 0.07 wt%, 0.075 wt%, or 0.08 wt%, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0045] ε-Polylysine, as a cationic polypeptide, can strongly adsorb onto the negatively charged bacterial cell membrane surface through electrostatic interactions, thereby disrupting the arrangement of the lipid bilayer and forming temporary pores. This leads to the leakage of key intracellular ions, energy substances, and other contents, resulting in the loss of cell membrane integrity. Benzalkonium chloride, as a quaternary ammonium salt surfactant, can damage the microbial cell membrane / wall. Furthermore, benzalkonium chloride can penetrate deeper into the cell, binding to the active sites of various intracellular enzymes and inactivating them. This directly blocks the core life activities of bacteria, such as the respiratory chain, energy synthesis, and nutrient metabolism, leading to bacterial death due to energy depletion and metabolic paralysis. The synergistic effect of these two substances is that ε-Polylysine initially disrupts the bacterial membrane structure, facilitating the entry of benzalkonium chloride molecules into the cell. Once inside the cell, benzalkonium chloride can strongly inhibit the activity of metabolic enzymes, causing bacteria to lose their ability to repair membrane damage.

[0046] In some optional instances, the mass fraction of disodium ethylenediaminetetraacetate in the synergistic antibacterial solution is 0.1 to 0.15 wt%, for example, it may be 0.1 wt%, 0.105 wt%, 0.11 wt%, 0.115 wt%, 0.12 wt%, 0.125 wt%, 0.13 wt%, 0.135 wt%, 0.14 wt%, 0.145 wt%, or 0.15 wt%, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0047] In some optional instances, the mass fraction of polyvinylpyrrolidone K30 in the synergistic antibacterial solution is 1 to 2 wt%, for example, it may be 1.0 wt%, 1.1 wt%, 1.2 wt%, 1.3 wt%, 1.4 wt%, 1.5 wt%, 1.6 wt%, 1.7 wt%, 1.8 wt%, 1.9 wt%, or 2.0 wt%, but is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0048] As a preferred embodiment of the present invention, in step (III), the carrier antibacterial solution is added dropwise to the synergistic antibacterial solution at a stirring speed of 300-500 rpm, for example, 300 rpm, 320 rpm, 340 rpm, 360 rpm, 380 rpm, 400 rpm, 420 rpm, 440 rpm, 460 rpm, 480 rpm, or 500 rpm, at a dropping rate of 1-2 mL / min, for example, 1.0 mL / min, 1.1 mL / min, 1.2 mL / min, 1.3 mL / min, etc. Add the solution at a rate of L / min, 1.4 mL / min, 1.5 mL / min, 1.6 mL / min, 1.7 mL / min, 1.8 mL / min, 1.9 mL / min, or 2.0 mL / min. After adding all the solution, continue stirring for 30 to 50 minutes, for example, 30 minutes, 32 minutes, 34 minutes, 36 minutes, 38 minutes, 40 minutes, 42 minutes, 44 minutes, 46 minutes, 48 ​​minutes, or 50 minutes. However, this is not limited to the listed values; other unlisted values ​​within this range are also applicable.

[0049] The main component of the carrier antibacterial solution is mesoporous silica loaded with PHMB. The mesoporous structure of the silica allows for the slow release of PHMB, which continuously releases the active ingredient and inhibits the regrowth of microorganisms, providing a sustained and effective antibacterial effect on the instrument surface. This solution aims to address the problem of easy loss of active ingredients in liquid disinfectants.

[0050] The enhanced antibacterial solution mainly contains bactericidal components that are fast-acting and broad-spectrum, providing immediate disinfection and sterilization effects. Benzalkonium chloride and ε-polylysine can disrupt cell membranes and inhibit cell metabolism, while EDTA-2Na enhances permeability by chelating metal ions to disrupt biomembrane structures. Polyvinylpyrrolidone K30 acts as a stabilizer to prevent component flocculation.

[0051] When the two are mixed in a certain proportion, the active ingredients in the synergistic antibacterial solution can quickly and immediately kill microorganisms on the surface of instruments, while the PHMB in the carrier antibacterial solution can be slowly released under the action of the mesoporous silica carrier, thus achieving long-lasting antibacterial effect and ultimately achieving a broad-spectrum, long-lasting and stable disinfection effect.

[0052] In some optional instances, the volume ratio of the carrier antibacterial solution to the synergistic antibacterial solution is 1:(4~6), for example, it can be 1:4.0, 1:4.2, 1:4.4, 1:4.6, 1:4.8, 1:5.0, 1:5.2, 1:5.4, 1:5.6, 1:5.8 or 1:6.0, but is not limited to the listed values, other unlisted values ​​within this range are also applicable.

[0053] This invention specifically limits the volume ratio of the carrier antibacterial solution to the synergistic antibacterial solution to 1:(4~6). If the amount of synergistic antibacterial solution is too low, the concentration of PHMB-loaded nanoparticles in the final disinfectant will be too high, easily leading to aggregation and precipitation, thus compromising product stability. Simultaneously, if the concentrations of benzalkonium chloride and ε-polylysine in the disinfectant are too low, it will affect the product's rapid and immediate sterilization capability during initial use. If the amount of synergistic antibacterial solution is too high, the concentration of PHMB-loaded nanoparticles in the final disinfectant will be too low, making it difficult to achieve a long-lasting antibacterial effect.

[0054] In some optional instances, the pH is adjusted to 5.5–6.5 after thorough mixing. For example, it could be 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, or 6.5, but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0055] Secondly, the present invention provides a disinfectant for medical devices prepared by the preparation method described in the first aspect.

[0056] Thirdly, the present invention provides a method of using the disinfectant for medical devices described in the second aspect, the method comprising:

[0057] The medical device is sprayed or evenly coated with a disinfectant and then allowed to air dry.

[0058] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0059] This invention uses aminated mesoporous silica as a sustained-release carrier, loading sodium carboxymethyl chitosan and polyhexamethylene biguanide hydrochloride (PHMB) through electrostatic interactions, and utilizing polyvinylpyrrolidone K30 as a stabilizer. This effectively prevents flocculation and precipitation when antibacterial components with different charges are mixed, ensuring the dispersion stability of the disinfectant. Furthermore, the bactericidal disinfection system designed in this invention includes a long-acting antibacterial component and an immediate bactericidal component. The long-acting antibacterial component is aminated mesoporous silica loaded with PHMB, while the immediate bactericidal component includes benzalkonium chloride and ε-polylysine. Additionally, the metal chelating agent disodium EDTA is added to enhance the penetration of the bactericidal components into biofilms and bacterial outer membranes. This results in a disinfectant that combines broad-spectrum antibacterial activity with long-acting antibacterial action, exhibiting superior overall performance compared to simple physical mixture disinfectants. Attached Figure Description

[0060] Figure 1 This is a flowchart illustrating the preparation process of a disinfectant for medical devices provided in Embodiment 1 of the present invention.

[0061] Figure 2This is a colony diagram of Staphylococcus aureus against the medical device disinfectant provided in Embodiment 1 of the present invention;

[0062] Figure 3 This is a colony diagram of Pseudomonas aeruginosa against the medical device disinfectant provided in Embodiment 1 of the present invention.

[0063] Figure 4 This is a colony diagram of Candida albicans against the medical device disinfectant provided in Embodiment 1 of the present invention. Detailed Implementation

[0064] The technical solutions of the present invention will be described in detail below with reference to specific embodiments and accompanying drawings. The embodiments described herein are specific implementations of the present invention, used to illustrate the concept of the present invention; these descriptions are explanatory and exemplary, and should not be construed as limiting the implementation methods or the scope of protection of the present invention. In addition to the embodiments described herein, those skilled in the art can employ other obvious technical solutions based on the content disclosed in the claims and specification of this application. These technical solutions include those that make any obvious substitutions and modifications to the embodiments described herein.

[0065] Example 1

[0066] This embodiment provides a method for preparing a disinfectant for medical devices, such as... Figure 1 As shown, the preparation method specifically includes the following steps:

[0067] (1) Mesoporous silica with an average pore size of 5 nm and an average diameter of 100 nm was dispersed in anhydrous ethanol and ultrasonically dispersed for 20 min under an ultrasonic power of 300 W to obtain a suspension with a mass fraction of 1 wt% of mesoporous silica in the suspension; 3-aminopropyltriethoxysilane was added dropwise to the suspension under a nitrogen atmosphere and stirring at 300 rpm, with a mass ratio of mesoporous silica to 3-aminopropyltriethoxysilane of 1:0.15. After all the addition was done, the mixture was refluxed at 75 °C for 12 h; after the reaction was completed, the reaction product was centrifuged at 3000 rpm for 10 min, the precipitate was washed until neutral, and finally dried at 60 °C for 12 h to obtain aminated mesoporous silica.

[0068] (2) The aminated mesoporous silica obtained in step (1) was dispersed in deionized water and ultrasonically dispersed for 20 min at an ultrasonic power of 300 W to obtain a dispersion with a mass fraction of 1 wt% of aminated mesoporous silica. Sodium carboxymethyl chitosan was added to the dispersion with a mass ratio of 1:1 between aminated mesoporous silica and sodium carboxymethyl chitosan. The mixture was stirred and heated at 40 °C and 300 rpm for 4 h. Subsequently, polyhexamethylene biguanide hydrochloride was added with a mass ratio of 0.4:1 between polyhexamethylene biguanide hydrochloride and sodium carboxymethyl chitosan. The mixture was stirred and heated at 40 °C and 300 rpm for 2 h to obtain a carrier antibacterial solution.

[0069] (3) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution. The mass fraction of benzalkonium chloride in the enhanced antibacterial solution is 0.15 wt%, the mass fraction of ε-polylysine is 0.08 wt%, the mass fraction of disodium ethylenediaminetetraacetate is 0.14 wt%, and the mass fraction of polyvinylpyrrolidone K30 is 1 wt%.

[0070] (4) At a stirring speed of 300 rpm, the carrier antibacterial solution obtained in step (2) is added dropwise to the enhanced antibacterial solution obtained in step (3) at a dropping rate of 1 mL / min. The volume ratio of the carrier antibacterial solution to the enhanced antibacterial solution is 1:4. After all the solution is added, continue stirring for 30 min. Finally, adjust the pH value to 5.5 to obtain the disinfectant for medical devices.

[0071] Example 2

[0072] This embodiment provides a method for preparing a disinfectant for medical devices, such as... Figure 1 As shown, the preparation method specifically includes the following steps:

[0073] (1) Mesoporous silica with an average pore size of 6 nm and an average diameter of 120 nm was dispersed in anhydrous ethanol and ultrasonically dispersed for 18 min at an ultrasonic power of 350 W to obtain a suspension with a mass fraction of 1.5 wt% of mesoporous silica in the suspension; 3-aminopropyltriethoxysilane was added dropwise to the suspension under a nitrogen atmosphere and stirring at 350 rpm, with a mass ratio of mesoporous silica to 3-aminopropyltriethoxysilane of 1:0.18. After all the addition was done, the mixture was refluxed at 78 °C for 10 h; after the reaction was completed, the reaction product was centrifuged at 3500 rpm for 8 min, the precipitate was washed until neutral, and finally dried at 65 °C for 10 h to obtain aminated mesoporous silica.

[0074] (2) The aminated mesoporous silica obtained in step (1) was dispersed in deionized water and ultrasonically dispersed for 18 min at an ultrasonic power of 350 W to obtain a dispersion with a mass fraction of 1.5 wt% of aminated mesoporous silica. Sodium carboxymethyl chitosan was added to the dispersion with a mass ratio of 1:1.1 between aminated mesoporous silica and sodium carboxymethyl chitosan. The mixture was stirred and heated at 42 °C and 350 rpm for 3.5 h. Subsequently, polyhexamethylene biguanide hydrochloride was added with a mass ratio of 0.42:1 between polyhexamethylene biguanide hydrochloride and sodium carboxymethyl chitosan. The mixture was stirred and heated at 42 °C and 350 rpm for 1.8 h to obtain a carrier antibacterial solution.

[0075] (3) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution. The mass fraction of benzalkonium chloride in the enhanced antibacterial solution is 0.16 wt%, the mass fraction of ε-polylysine is 0.08 wt%, the mass fraction of disodium ethylenediaminetetraacetate is 0.13 wt%, and the mass fraction of polyvinylpyrrolidone K30 is 1.2 wt%.

[0076] (4) At a stirring speed of 350 rpm, the carrier antibacterial solution obtained in step (2) is added dropwise to the enhanced antibacterial solution obtained in step (3) at a dropping rate of 1.2 mL / min. The volume ratio of the carrier antibacterial solution to the enhanced antibacterial solution is 1:4.5. After all the solution is added, continue stirring for 35 min. Finally, adjust the pH value to 5.8 to obtain the disinfectant for medical devices.

[0077] Example 3

[0078] This embodiment provides a method for preparing a disinfectant for medical devices, such as... Figure 1 As shown, the preparation method specifically includes the following steps:

[0079] (1) Mesoporous silica with an average pore size of 7 nm and an average diameter of 150 nm was dispersed in anhydrous ethanol and ultrasonically dispersed for 15 min at an ultrasonic power of 400 W to obtain a suspension with a mass fraction of 2 wt% of mesoporous silica in the suspension; 3-aminopropyltriethoxysilane was added dropwise to the suspension under a nitrogen atmosphere and stirring at 400 rpm, with a mass ratio of mesoporous silica to 3-aminopropyltriethoxysilane of 1:0.2. After all the addition was done, the mixture was refluxed at 80 °C for 8 h; after the reaction was completed, the reaction product was centrifuged at 4000 rpm for 7 min, the precipitate was washed until neutral, and finally dried at 70 °C for 8 h to obtain aminated mesoporous silica.

[0080] (2) The aminated mesoporous silica obtained in step (1) was dispersed in deionized water and ultrasonically dispersed for 15 min at an ultrasonic power of 400 W to obtain a dispersion with a mass fraction of 2 wt% of aminated mesoporous silica. Sodium carboxymethyl chitosan was added to the dispersion with a mass ratio of 1:1.2 between aminated mesoporous silica and sodium carboxymethyl chitosan. The mixture was stirred and heated at 45 °C and 400 rpm for 3 h. Subsequently, polyhexamethylene biguanide hydrochloride was added with a mass ratio of 0.45:1 between polyhexamethylene biguanide hydrochloride and sodium carboxymethyl chitosan. The mixture was stirred and heated at 45 °C and 400 rpm for 1.5 h to obtain a carrier antibacterial solution.

[0081] (3) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution. The mass fraction of benzalkonium chloride in the enhanced antibacterial solution is 0.17 wt%, the mass fraction of ε-polylysine is 0.07 wt%, the mass fraction of disodium ethylenediaminetetraacetate is 0.13 wt%, and the mass fraction of polyvinylpyrrolidone K30 is 1.5 wt%.

[0082] (4) At a stirring speed of 400 rpm, the carrier antibacterial solution obtained in step (2) is added dropwise to the enhanced antibacterial solution obtained in step (3) at a dropping speed of 1.5 mL / min. The volume ratio of the carrier antibacterial solution to the enhanced antibacterial solution is 1:5. After all the solution is added, continue stirring for 40 min. Finally, adjust the pH value to 6.0 to obtain the disinfectant for medical devices.

[0083] Example 4

[0084] This embodiment provides a method for preparing a disinfectant for medical devices, such as... Figure 1 As shown, the preparation method specifically includes the following steps:

[0085] (1) Mesoporous silica with an average pore size of 8 nm and an average diameter of 180 nm was dispersed in anhydrous ethanol and ultrasonically dispersed for 12 min at an ultrasonic power of 450 W to obtain a suspension with a mass fraction of 2.5 wt% of mesoporous silica in the suspension; 3-aminopropyltriethoxysilane was added dropwise to the suspension under a nitrogen atmosphere and stirring at 450 rpm, with a mass ratio of mesoporous silica to 3-aminopropyltriethoxysilane of 1:0.22. After all the addition was done, the mixture was refluxed at 82 °C for 7 h; after the reaction was completed, the reaction product was centrifuged at 4500 rpm for 6 min, the precipitate was washed until neutral, and finally dried at 75 °C for 7 h to obtain aminated mesoporous silica.

[0086] (2) The aminated mesoporous silica obtained in step (1) was dispersed in deionized water and ultrasonically dispersed for 12 min at an ultrasonic power of 450 W to obtain a dispersion with a mass fraction of 2.5 wt% of aminated mesoporous silica. Sodium carboxymethyl chitosan was added to the dispersion with a mass ratio of 1:1.3 between aminated mesoporous silica and sodium carboxymethyl chitosan. The mixture was stirred and heated at 48 °C and 450 rpm for 2.5 h. Subsequently, polyhexamethylene biguanide hydrochloride was added with a mass ratio of 0.48:1 between polyhexamethylene biguanide hydrochloride and sodium carboxymethyl chitosan. The mixture was stirred and heated at 48 °C and 450 rpm for 1.2 h to obtain a carrier antibacterial solution.

[0087] (3) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution. The mass fraction of benzalkonium chloride in the enhanced antibacterial solution is 0.18 wt%, the mass fraction of ε-polylysine is 0.03 wt%, the mass fraction of disodium ethylenediaminetetraacetate is 0.15 wt%, and the mass fraction of polyvinylpyrrolidone K30 is 1.8 wt%.

[0088] (4) At a stirring speed of 450 rpm, the carrier antibacterial solution obtained in step (2) is added dropwise to the enhanced antibacterial solution obtained in step (3) at a dropping rate of 1.8 mL / min. The volume ratio of the carrier antibacterial solution to the enhanced antibacterial solution is 1:5.5. After all the solution is added, continue stirring for 45 min. Finally, adjust the pH value to 6.2 to obtain the disinfectant for medical devices.

[0089] Example 5

[0090] This embodiment provides a method for preparing a disinfectant for medical devices, such as... Figure 1 As shown, the preparation method specifically includes the following steps:

[0091] (1) Mesoporous silica with an average pore size of 10 nm and an average diameter of 200 nm was dispersed in anhydrous ethanol and ultrasonically dispersed for 10 min under an ultrasonic power of 500 W to obtain a suspension with a mass fraction of 3 wt% of mesoporous silica in the suspension; 3-aminopropyltriethoxysilane was added dropwise to the suspension under a nitrogen atmosphere and stirring at 500 rpm, with a mass ratio of mesoporous silica to 3-aminopropyltriethoxysilane of 1:0.25. After all the addition was done, the mixture was refluxed at 85 °C for 6 h; after the reaction was completed, the reaction product was centrifuged at 5000 rpm for 5 min, the precipitate was washed until neutral, and finally dried at 80 °C for 6 h to obtain aminated mesoporous silica.

[0092] (2) The aminated mesoporous silica obtained in step (1) was dispersed in deionized water and ultrasonically dispersed for 10 min at an ultrasonic power of 500 W to obtain a dispersion with a mass fraction of 3 wt% of aminated mesoporous silica. Sodium carboxymethyl chitosan was added to the dispersion with a mass ratio of 1:1.5 between aminated mesoporous silica and sodium carboxymethyl chitosan. The mixture was stirred and heated at 50 °C and 500 rpm for 2 h. Subsequently, polyhexamethylene biguanide hydrochloride was added with a mass ratio of 0.5:1 between polyhexamethylene biguanide hydrochloride and sodium carboxymethyl chitosan. The mixture was stirred and heated at 50 °C and 500 rpm for 1 h to obtain a carrier antibacterial solution.

[0093] (3) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution. The mass fraction of benzalkonium chloride in the enhanced antibacterial solution is 0.2 wt%, the mass fraction of ε-polylysine is 0.06 wt%, the mass fraction of disodium ethylenediaminetetraacetate is 0.1 wt%, and the mass fraction of polyvinylpyrrolidone K30 is 2 wt%.

[0094] (4) At a stirring speed of 500 rpm, the carrier antibacterial solution obtained in step (2) is added dropwise to the enhanced antibacterial solution obtained in step (3) at a dropping speed of 2 mL / min. The volume ratio of the carrier antibacterial solution to the enhanced antibacterial solution is 1:6. After all the solution is added, continue stirring for 50 min. Finally, adjust the pH value to 6.5 to obtain the disinfectant for medical devices.

[0095] Example 6

[0096] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the mass ratio of mesoporous silica to APTES is adjusted to 1:0.1, while the other operating steps and process parameters are exactly the same as in Embodiment 1.

[0097] Example 7

[0098] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the mass ratio of mesoporous silica to APTES is adjusted to 1:0.3, while the other operating steps and process parameters are exactly the same as in Embodiment 1.

[0099] Example 8

[0100] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the mass ratio of aminated mesoporous silica to sodium carboxymethyl chitosan is adjusted to 1:0.5, while the other operating steps and process parameters are exactly the same as in Embodiment 1.

[0101] Example 9

[0102] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the mass ratio of aminated mesoporous silica to sodium carboxymethyl chitosan is adjusted to 1:2, while the other operating steps and process parameters are exactly the same as in Embodiment 1.

[0103] Example 10

[0104] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the mass ratio of polyhexamethylene biguanide hydrochloride to sodium carboxymethyl chitosan is adjusted to 0.2:1. Other operating steps and process parameters are exactly the same as in Embodiment 1.

[0105] Example 11

[0106] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the mass ratio of polyhexamethylene biguanide hydrochloride to sodium carboxymethyl chitosan is adjusted to 0.8:1. Other operating steps and process parameters are exactly the same as in Embodiment 1.

[0107] Example 12

[0108] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the volume ratio of the carrier antibacterial solution to the synergistic antibacterial solution is adjusted to 1:2, while the other operating steps and process parameters are exactly the same as in Embodiment 1.

[0109] Example 13

[0110] This embodiment provides a method for preparing a disinfectant for medical devices. The difference from Embodiment 1 is that the volume ratio of the carrier antibacterial solution to the synergistic antibacterial solution is adjusted to 1:8, while the other operating steps and process parameters are exactly the same as in Embodiment 1.

[0111] The corrosiveness and laboratory microbial killing index of the disinfectants for medical devices prepared in Examples 1-13 were tested in accordance with the national standard GB 27949-2020 "General Requirements for Disinfectants for Medical Devices".

[0112] (1) Metal corrosion test of disinfectant

[0113] Referring to the national standard GB / T 38498-2020 "Evaluation Method for Metal Corrosion of Disinfectants", the specific test steps are as follows:

[0114] Carbon steel sheets, copper sheets, aluminum sheets and stainless steel sheets were pretreated using the sample pretreatment method provided by the national standard. They were then immersed in 500 mL of the medical device disinfectant prepared in Example 1 for 72 hours. After immersion, they were taken out, cleaned and weighed, the corrosion rate was calculated and the corrosion level was determined according to the national standard.

[0115] The test results of corrosion rate and corrosion level are shown in Table 1.

[0116] Table 1

[0117]

[0118] Table 1 shows the corrosivity of the disinfectant provided in Example 1 of this invention to four common metals. Stainless steel exhibits the best resistance, with a corrosion rate of only 0.0018 mm / a, falling into the "virtually non-corrosive" category. This indicates that the disinfectant prepared according to this invention can be widely used in medical devices made of stainless steel. The corrosion rates of aluminum and copper are 0.0054 mm / a and 0.0087 mm / a, respectively, still within the "virtually non-corrosive" category, and their corrosive impact on these two metals is within acceptable limits.

[0119] (2) Laboratory test of microbial killing indicators

[0120] The laboratory microbial killing index of disinfectants was tested according to the carrier immersion quantitative bactericidal test provided in the national standard GB / T 38502-2020 "Laboratory Test Methods for the Bactericidal Efficacy of Disinfectants". The specific test steps are as follows:

[0121] Standard strains of Staphylococcus aureus (ATCC 6538), Pseudomonas aeruginosa (ATCC 15442), and Candida albicans (ATCC 10231) were selected to prepare experimental bacterial discs. The discs were carried by stainless steel discs, and the number of recovered bacteria per disc was 1 × 10⁻⁶. 6 CFU / tablet ~5×10 6 CFU / film.

[0122] Take a sterile petri dish and add 5.0 mL of the disinfectant prepared in the example into each dish. Place the petri dish containing the disinfectant in a water bath at 20℃±1℃ for 5 minutes. Use sterile forceps to take 3 pre-prepared bacterial tablets and place them into the petri dish, immersing them in the disinfectant solution. This time is T0.

[0123] After the bacterial solution and disinfectant have interacted for the set time (T0+5min, T0+1h, T0+2h, T0+4h, and T0+6h), use sterile forceps to remove the bacterial slabs and transfer them into a test tube containing 5.0mL of neutralizing agent. Mix with an electric mixer for 20s, or shake the test tube on your palm 80 times for 10min of neutralization. After mixing, take 1.0mL and inoculate it directly into a Petri dish. Inoculate two Petri dishes from each tube and determine the number of viable bacteria.

[0124] Take another petri dish, add 10.0 mL of diluent instead of disinfectant, and place 2 bacterial tablets in it as a control group. The subsequent experimental steps and viable cell counts are the same as those of the experimental group.

[0125] All test samples were cultured in a constant temperature incubator at 36℃±1℃ for 48 hours for bacterial vegetative cells and 72 hours for bacterial spores.

[0126] The experiment was repeated three times. The viable bacterial count (CFU / tablet) of each group was calculated and converted to logarithmic value (N). The logarithmic kill value (KL) was calculated according to the following formula:

[0127] KL=N0-N x

[0128] Where N0 is the logarithm of the average viable count in the control group, N x This is the logarithm of the average viable count in the experimental group.

[0129] The test results of the disinfectant's logarithmic killing effect on Staphylococcus aureus at different time points are shown in Table 2.

[0130] Table 2

[0131]

[0132] The test results of the disinfectant's logarithmic killing effect on Pseudomonas aeruginosa at different time points are shown in Table 3.

[0133] Table 3

[0134]

[0135] The test results of the disinfectant's logarithmic killing effect on Candida albicans at different time points are shown in Table 4.

[0136] Table 4

[0137]

[0138] As can be seen from the test data provided in Tables 2, 3 and 4, Examples 1-5 maintained extremely high kill log values ​​(KL>4) throughout the entire 6-hour test period, which meets the requirements of the national standard GB 27949-2020 "General Requirements for Disinfectants for Medical Devices" for the bactericidal performance of disinfectants (KL>3), proving that they have excellent immediate killing and long-lasting antibacterial capabilities.

[0139] In Examples 6 and 7, the mass ratio of mesoporous silica to APTES was adjusted. Over time, the kill log value continued to decrease, indicating that the degree of amination of the silica carrier affected the stable loading and sustained release of PHMB, resulting in a reduction in the long-term antibacterial ability of the disinfectant.

[0140] Examples 8 and 9 adjusted the mass ratio of aminated mesoporous silica to sodium carboxymethyl chitosan. Over time, the kill log value continued to decrease, indicating that the incomplete carrier coating layer affected the long-lasting antibacterial ability of the product.

[0141] In Examples 10 and 11, the mass ratio of polyhexamethylene biguanide hydrochloride to sodium carboxymethyl chitosan was adjusted. In Example 10, the initial test showed a good bactericidal effect, but the long-term antibacterial effect was poor. This indicates that the dosage of PHMB as a long-term antibacterial component was too low, resulting in a reduction in its long-term antibacterial ability. In Example 11, the antibacterial effect at each time point was poor. This was because excessive PHMB interfered with the stability of the product.

[0142] In Examples 12 and 13, the volume ratio of the carrier antibacterial solution to the synergistic antibacterial solution was adjusted. In Example 12, the amount of synergistic antibacterial solution was too low and the amount of carrier antibacterial solution was too high, resulting in insufficient immediate bactericidal components and poor initial killing effect, but the subsequent antibacterial effect was slightly improved. In Example 13, the amount of synergistic antibacterial solution was too high, resulting in good killing effect in the early stage of the test, but poor long-term antibacterial effect.

[0143] The applicant declares that the above description is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention fall within the protection and disclosure scope of the present invention.

Claims

1. A method for preparing a disinfectant for medical devices, characterized in that, The preparation method includes: (I) Aminated mesoporous silica is dispersed in deionized water and ultrasonically dispersed to obtain a dispersion. Sodium carboxymethyl chitosan is added to the dispersion and a first stirring and heating reaction is carried out. Then, polyhexamethylene biguanide hydrochloride is added and a second stirring and heating reaction is carried out to obtain a carrier antibacterial solution. (II) Add benzalkonium chloride, ε-polylysine, disodium ethylenediaminetetraacetate and polyvinylpyrrolidone K30 to deionized water, mix and stir evenly to obtain an enhanced antibacterial solution; (III) Under stirring conditions, the carrier antibacterial solution is added to the enhanced antibacterial solution, mixed evenly, and the pH value is adjusted to obtain the disinfectant for medical devices.

2. The preparation method according to claim 1, characterized in that, In step (I), the aminated mesoporous silica is prepared by the following method: Mesoporous silica was dispersed in anhydrous ethanol and ultrasonically dispersed to obtain a suspension. Under nitrogen atmosphere and stirring conditions, 3-aminopropyltriethoxysilane was added dropwise to the suspension and refluxed. After the reaction was completed, the aminated mesoporous silica was obtained by centrifugation, washing and drying.

3. The preparation method according to claim 2, characterized in that, The average pore size of the mesoporous silica is 5~10 nm; The average diameter of the mesoporous silica is 100~200 nm; The mass fraction of mesoporous silica in the suspension is 1-3 wt%. The mass ratio of the mesoporous silica to 3-aminopropyltriethoxysilane is 1:(0.15~0.25); The reflux reaction temperature is 75~85℃; The reflux reaction time is 6-12 hours.

4. The preparation method according to claim 1, characterized in that, In step (I), the mass fraction of aminated mesoporous silica in the dispersion is 1-3 wt%. The ultrasonic power of the ultrasonic dispersion is 300~500W; The ultrasonic dispersion time is 10-20 minutes.

5. The preparation method according to claim 1, characterized in that, In step (I), the mass ratio of the aminated mesoporous silica to the sodium carboxymethyl chitosan is 1:(1~1.5); The temperature of the first stirring and heating reaction is 40~50℃; The first stirring and heating reaction takes 2 to 4 hours.

6. The preparation method according to claim 1, characterized in that, In step (I), the mass ratio of the polyhexamethylene biguanide hydrochloride to the sodium carboxymethyl chitosan is (0.4~0.5):1; The temperature of the second stirring and heating reaction is 40~50℃; The second stirring and heating reaction takes 1 to 2 hours.

7. The preparation method according to claim 1, characterized in that, In step (II), the mass fraction of benzalkonium chloride in the synergistic antibacterial solution is 0.15~0.2wt%. The mass fraction of ε-polylysine in the synergistic antibacterial solution is 0.03~0.08 wt%. The mass fraction of disodium ethylenediaminetetraacetate in the synergistic antibacterial solution is 0.1~0.15 wt%. The mass fraction of polyvinylpyrrolidone K30 in the enhanced antibacterial solution is 1~2wt%.

8. The preparation method according to claim 1, characterized in that, In step (III), the carrier antibacterial solution is added dropwise to the enhanced antibacterial solution at a stirring speed of 300-500 rpm at a dropping rate of 1-2 mL / min. After all the solution has been added, stirring is continued for 30-50 min. The volume ratio of the carrier antibacterial solution to the synergistic antibacterial solution is 1:(4~6); After mixing thoroughly, adjust the pH value to 5.5-6.

5.

9. A disinfectant for medical devices prepared by the preparation method according to any one of claims 1 to 8.

10. A method of using the disinfectant for medical devices according to claim 9, characterized in that, The method of use includes: The medical device is sprayed or evenly coated with a disinfectant and then allowed to air dry.

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