Medical instrument humectant and preparation method thereof

Abstract

The invention provides a medical instrument humectant and a preparation method thereof. The medical instrument humectant comprises the following components: 5-10 parts of a first anionic surfactant; 1-4 parts of a zwitterionic surfactant; 1-3 parts of a second anionic surfactant; 2 to 5 parts of a polyol humectant; 0.10 to 0.30 part of a first bacteriostatic agent; 0.1 to 0.4 part of an organic phosphonic acid antirust agent; 1-4 parts of a small molecule polyol humectant; 0.01 to 0.08 part of a second bacteriostatic agent; 0.005 to 0.03 part of protease; and the balance of deionized water. According to the present invention, the inhibition rate of common pathogenic bacteria can be improved, and the antibacterial duration can be prolonged; the anti-rust performance is improved; protein residues on the surface of the instrument are efficiently decomposed, meanwhile, a stable moisturizing film is formed, and synergistic cleaning and moisturizing are achieved; the product stability is improved, and layering and precipitation in the storage process are avoided.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical instrument nursing, and particularly relates to a medical instrument moisturizer and a preparation method thereof. BACKGROUND

[0002] Medical instruments such as surgical scissors, hemostatic forceps and flexible endoscopes need to be cleaned, moisturized and disinfected after use so as to meet the standards. The Technical Standard for Cleaning and Disinfection of Flexible Endoscopes stipulates that the endoscope should be cleaned and disinfected in time after use, the transport container should be airtight, and the time interval from use to cleaning should not exceed 30 minutes. Therefore, for the flexible endoscope, if the transfer time may exceed 30 minutes, measures need to be taken to prevent the dirt from drying, for example, a moisturizer is used.

[0003] The moisturizer can form a protective film on the surface of the medical instrument such as the flexible endoscope, reduce oxidation and rust, inhibit the growth of microorganisms, prolong the service life of the medical instrument and reduce the risk of cross infection. Therefore, the medical instrument moisturizer has become a key product for clinical instrument nursing and disinfection.

[0004] At present, the formula of the medical instrument moisturizer is mainly suitable for metal parts, and the bacteriostatic and moisturizing effects on other materials are weak, and it is not directly applicable. However, medical instruments are not entirely composed of metal parts, for example, flexible endoscopes may also include silicone rubber, Teflon and other special materials.

[0005] Therefore, the technical problem to be solved at present is to develop a medical instrument moisturizer which has significant bacteriostatic effect, excellent rust prevention performance, high cleaning and moisturizing synergistic efficiency and strong stability, and can also be applied to parts such as silicone hoses other than metals. SUMMARY

[0006] The present application is carried out to solve the above problems, and aims to provide a medical instrument moisturizer and a preparation method thereof, which overcome the defects of the existing medical instrument moisturizer such as insufficient bacteriostatic effect, short rust prevention time, poor cleaning and moisturizing synergistic effect and poor product stability.

[0007] The present application provides a medical instrument moisturizer, which has the following characteristics: 5-10 parts of a first anionic surfactant; 1-4 parts of a zwitterionic surfactant; 1-3 parts of a second anionic surfactant; 2-5 parts of a polyol moisturizer; 0.10-0.30 parts of a first bacteriostatic agent; 0.1-0.4 parts of an organic phosphonic acid rust inhibitor; 1-4 parts of a small molecule polyol moisturizer; 0.01-0.08 parts of a second bacteriostatic agent; 0.005-0.03 parts of a protease; and the balance is deionized water.

[0008] In the medical device moisturizer provided by the application, the first anionic surfactant can be sodium lauryl ether sulfate, the zwitterionic surfactant can be cocamidopropyl betaine, and the second anionic surfactant can be sodium dodecyl sulfate. The mass ratio of the sodium lauryl ether sulfate and the cocamidopropyl betaine is 7: (2-4).

[0009] In the medical device moisturizer provided by the application, the first bacteriostatic agent can be triclosan, and the second bacteriostatic agent can be methylisothiazolinone. The mass ratio of the triclosan and the methylisothiazolinone is (4-6): 1.

[0010] In the medical device moisturizer provided by the application, the polyhydric alcohol moisturizer can be polyethylene glycol, and the average molecular weight of the polyethylene glycol is 200-400 g / mol.

[0011] In an embodiment, the polyethylene glycol is polyethylene glycol-400.

[0012] In the medical device moisturizer provided by the application, the organic phosphonic acid-based rust inhibitor can be diethylenetriamine penta(methylene phosphonic acid), and the small-molecule polyhydric alcohol moisturizer can be at least one of propylene glycol, 1,3-propanediol, or butanediol.

[0013] In the medical device moisturizer provided by the application, the mass ratio of the small-molecule polyhydric alcohol moisturizer to the polyhydric alcohol moisturizer is 1: (1-2).

[0014] In an embodiment, the mass ratio of the propylene glycol to the polyethylene glycol-400 is 1:1.5.

[0015] The application further provides a preparation method of the medical device moisturizer, which comprises the following steps: adding 5-10 parts of the first anionic surfactant, 1-4 parts of the zwitterionic surfactant, 1-3 parts of the second anionic surfactant, 2-5 parts of the polyhydric alcohol moisturizer, and 0.10-0.30 parts of the first bacteriostatic agent into deionized water to obtain a first mixed solution, heating and stirring the first mixed solution until all the components are completely dissolved to form a uniform and transparent phase A; The temperature of the phase A is reduced to 30-40°C to obtain a cooled phase A; The organic phosphonic acid-based rust inhibitor (0.1-0.4 parts), the small-molecule polyhydric alcohol moisturizer (1-4 parts), the second bacteriostatic agent (0.01-0.08 parts), and the protease (0.005-0.03 parts) are sequentially added into the cooled phase A, and stirred for 10-20 minutes to obtain a phase B; Phase B was allowed to stand and filtered to remove tiny particulate impurities, yielding a medical device moisturizer.

[0016] The preparation method of the medical device moisturizer provided by the present invention may also have the following feature: wherein, when heating and stirring the first mixture until all components are completely dissolved, the heating temperature is 70~80℃.

[0017] In one embodiment, the heating temperature is 80°C.

[0018] The preparation method of the medical device moisturizer provided by the present invention may also have the following characteristics: when heating and stirring the first mixture until all components are completely dissolved, the stirring time is 40 to 60 minutes and the stirring speed is 80 to 120 rpm.

[0019] In one embodiment, the stirring speed is 100 rpm.

[0020] The preparation method of the medical device moisturizer provided by the present invention may also have the following characteristics: when the B phase is allowed to stand and filtered, the standing time is at least 12 hours, and the filtration uses a filter screen with a mesh size of not less than 400.

[0021] In one embodiment, the settling time is 12 hours, and a 400-mesh filter is used for filtration.

[0022] The role and effect of invention The medical device moisturizer and its preparation method according to the present invention have the following beneficial effects: The present invention forms a dual antibacterial system by simultaneously using triclosan and methylisothiazolinone, producing a synergistic effect, achieving an inhibition rate of ≥99% against common pathogenic bacteria such as Escherichia coli, Staphylococcus aureus, and Candida albicans, and prolonging the duration of antibacterial action; the addition of diethylenetriaminepentamethylphosphonic acid ensures that medical devices do not show significant corrosion after 168 hours of storage in a humid environment, improving rust prevention performance; it efficiently decomposes protein residues on the surface of medical devices while forming a stable moisturizing film, achieving synergistic cleaning and moisturizing; it improves product stability, avoids stratification and sedimentation during storage, and extends the shelf life to more than 12 months; it also has good moisturizing and antibacterial effects on non-metallic parts of medical devices such as silicone tubing and Teflon, making it more suitable for flexible endoscopes such as gastroscopes, colonoscopes, and bronchoscopes. Detailed Implementation

[0023] The technical solutions disclosed in this invention will be described in detail below with reference to specific embodiments.

[0024] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] To make the technical means, creative features, objectives and effects of this invention easy to understand, the following embodiments specifically illustrate the medical device moisturizer and its preparation method of this invention.

[0026] This invention provides a medical device moisturizer for clinical instrument care, primarily used in the pretreatment stage after use and before formal cleaning and disinfection of medical devices. During pretreatment, medical personnel immerse the medical devices in the moisturizer according to standard operating procedures to prevent contaminants on the device surface from drying out and to inhibit microbial growth, thus laying the foundation for subsequent formal disinfection. Furthermore, this medical device moisturizer not only moisturizes metal surfaces but also exhibits good moisturizing effects on special materials such as silicone and Teflon, making it more suitable for flexible endoscopes such as gastroscopes, colonoscopes, and bronchoscopes.

[0027] The medical device moisturizer provided in this invention comprises, by weight, the following components: 5-10 parts of a first anionic surfactant; 1-4 parts of an amphoteric surfactant; 1-3 parts of a second anionic surfactant; 2-5 parts of a polyol moisturizer; 0.10-0.30 parts of a first antibacterial agent; 0.1-0.4 parts of an organophosphonic acid rust inhibitor; 1-4 parts of a small molecule polyol moisturizer; 0.01-0.08 parts of a second antibacterial agent; 0.005-0.03 parts of a protease; and the balance being deionized water.

[0028] The first anionic surfactant, acting as the primary cleaning agent, is mainly used for removing dirt, dispersing grease, and resolving particulate residues of contaminants during the use of medical devices. In this invention, sodium lauryl ether sulfate is selected as the first anionic surfactant, providing basic and highly efficient cleaning power to ensure the removal of physical residues from the surface of medical devices.

[0029] Amphoteric surfactants are used in conjunction with a first anionic surfactant for auxiliary cleaning. In this invention, cocamidopropyl betaine is selected and compounded with sodium lauryl ether sulfate to optimize the overall performance of the system.

[0030] The second anionic surfactant plays a synergistic role in cleaning and wetting, reducing the surface tension of the medical device moisturizer and helping it to spread and penetrate better. This invention uses sodium dodecyl sulfate, which not only enhances the overall cleaning effect of the medical device moisturizer but also ensures that, when the medical device is immersed in the moisturizer according to standard operating procedures, the moisturizer evenly covers the surface of the medical device.

[0031] In this invention, the mass ratio of sodium lauryl ether sulfate and cocamidopropyl betaine is set to 7:(2~4). Within this ratio range, sodium lauryl ether sulfate and cocamidopropyl betaine can produce the best synergistic effect. While sodium lauryl ether sulfate provides sufficient dominant cleaning power, cocamidopropyl betaine can form a stable mixed micelle structure with it. In actual use, since the structure of medical devices is usually quite complex and delicate, with many cavities inside, this configuration ratio can prolong the contact and interaction time between the active ingredients and the surface of the medical device, while making the overall viscosity suitable and ensuring a balance between coverage and flowability.

[0032] The first antibacterial agent is used to construct the first line of defense in an antibacterial system, typically for the efficient killing of common bacteria. In this invention, triclosan is selected as the first antibacterial agent, which has a broad-spectrum antibacterial effect and exerts its antibacterial effect primarily by disrupting the cell membrane structure.

[0033] The second antibacterial agent is methylisothiazolinone, which is highly effective against both bacteria and fungi by interfering with cell metabolism. In this invention, methylisothiazolinone and triclosan are used together as antibacterial components, and the mass ratio of triclosan to methylisothiazolinone is set at (4~6):1. During use, triclosan preferentially disrupts the cell membrane structure to achieve broad-spectrum antibacterial activity, while methylisothiazolinone then enters the cell to better interfere with metabolism. The two agents work synergistically and complementaryly, significantly expanding the antibacterial spectrum while ensuring long-lasting antibacterial effects.

[0034] Polyol moisturizers can achieve long-lasting hydration and form a film on the surface of medical devices, creating a stable hydrophilic protective film that locks in moisture. In this invention, polyethylene glycol is selected as the polyol moisturizer. The average molecular weight of polyethylene glycol is 200~400 g / mol, mainly polyethylene glycol-200 and polyethylene glycol-400. This prevents medical devices from drying out and losing water during storage, thereby avoiding contaminants from penetrating and adhering to the surface of the medical devices before formal cleaning begins.

[0035] Small molecule polyol moisturizers are mainly used for immediate moisturizing and penetration enhancement. In this invention, the small molecule polyol moisturizer is selected from at least one of propylene glycol, 1,3-propanediol or butylene glycol. It can quickly capture moisture and can be used as a solvent for other functional ingredients. Propylene glycol is the most preferred, as it can not only provide a rapid moisturizing effect, but also assist in the dissolution and penetration of other effective ingredients.

[0036] In this invention, the mass ratio of propylene glycol to polyethylene glycol is set to 1:(1~2). Propylene glycol, a small-molecule polyol humectant, rapidly attracts and penetrates water, providing immediate hydration. Polyethylene glycol-400 is used to form a continuous physical water-locking film on the surface of the medical device. Through intermolecular interactions, the two work together to construct a stable composite humidifying film structure, ensuring that the moisturizing components on the surface of the medical device maintain long-lasting adhesion and high humidifying performance.

[0037] Organophosphonic acid rust inhibitors are primarily used to actively protect metal instruments in humid environments, preventing corrosion caused by moisture. This invention uses diethylenetriaminepentamethylenephosphonic acid, which works by chelating metal ions on the surface of medical instruments to prevent corrosion.

[0038] When propylene glycol is used in combination with diethylenetriaminepentamethylenephosphonic acid (DIPA), it improves the uniformity of DIPA's dissolution in the system, allowing it to more effectively chelate metal ions and firmly adsorb onto the surface of medical devices, preventing corrosion. Simultaneously, propylene glycol itself forms a stable moisturizing layer on the surface of the medical devices. The synergistic effect of both creates a dual protective network of chemical chelation barrier and physical moisturizing, achieving efficient and long-lasting balance between rust prevention and moisturizing functions in humid environments.

[0039] Proteases are mainly used to solve protein residues that are difficult to remove during the cleaning process. Based on the application scenario of this invention, the pretreatment of medical devices such as flexible endoscopes is used, and the main contaminants targeted are protein stains, such as blood and human tissue.

[0040] When bronchoscopy requires disinfection and pretreatment, the focus is usually on sputum; when gastroscopy and colonoscopy require disinfection and pretreatment, the focus is usually on secretions and blood. These protein-based contaminants can coagulate on the anterior endoscope of a flexible endoscope, forming a biofilm. Once formed, this biofilm is extremely difficult to thoroughly clean and disinfect. Therefore, this invention uses alkaline protease, which can effectively decompose protein-based contaminants on the surface of the anterior endoscope, playing a deep cleaning role in the system.

[0041] In summary, this invention cleans surface stains on medical devices using a first anionic surfactant, an amphoteric surfactant, and a second anionic surfactant. Simultaneously, it combines with a protease to specifically target and deeply clean protein-based stains, which are most common during the use of medical devices. The synergistic effect of the first and second antibacterial agents achieves broad-spectrum sterilization. In this invention, the polyol humectant forms a protective film on the surface of the medical device, primarily for water retention. However, a humid environment is a major condition for inducing corrosion. Therefore, the inventors further added a certain proportion of organophosphonic acid rust inhibitors to the system, dissolving them into the humidifying film. These organophosphonic acid rust inhibitors can chelate free iron ions from the metal surface of the medical device, fundamentally inhibiting corrosion.

[0042] Example 1 This embodiment discloses a method for preparing a medical device moisturizer A, which specifically includes the following steps: Preparation of Phase A: Take 7 parts of sodium lauryl ether sulfate, 3 parts of cocamidopropyl betaine, 1.5 parts of sodium dodecyl sulfate, 3 parts of PEG-400 (i.e., polyethylene glycol-400), and 0.25 parts of triclosan and add them to 82.58 parts of deionized water to obtain the first mixture. Heat the mixture to 80°C and stir it at 100 rpm until all components are completely dissolved to form a uniform and transparent Phase A.

[0043] Cooling treatment: The temperature of phase A is reduced to 40℃ to obtain the cooled phase A.

[0044] Compound mixing: Add 0.6 parts of diethylenetriaminepentamidephosphonic acid, 2 parts of propylene glycol, 0.05 parts of methylisothiazolinone, and 0.02 parts of alkaline protease to the cooled phase A in sequence, stir for 20 minutes until all components are fully mixed and homogeneous to obtain phase B.

[0045] Post-processing: Phase B was allowed to stand for 12 hours, then filtered through a 400-mesh filter to remove tiny particulate impurities, and finally aseptically filled to obtain medical device moisturizer A.

[0046] In this embodiment, the components are synergistically designed: by simultaneously using triclosan and methylisothiazolinone, a dual antibacterial system is formed, enabling the system to possess both broad-spectrum antibacterial and highly effective antibacterial effects, effectively solving the problem of incomplete antibacterial action of existing single-component moisturizers. In the system of this invention, triclosan preferentially disrupts the bacterial cell membrane, allowing methylisothiazolinone to successfully enter the bacterial interior and bind to multiple targets such as bacterial DNA and key metabolic enzymes, thus completely killing the bacteria. The two work together synergistically to kill bacteria, not only improving the bactericidal speed but also reducing the possibility of bacteria developing drug resistance, enabling this invention to achieve a highly efficient and long-lasting broad-spectrum antibacterial effect.

[0047] However, this system can lead to a conflict between cleaning and antibacterial properties. To address this, the alkaline protease used in this embodiment can achieve enzymatic cleaning within the system, thus achieving a synergistic effect between antibacterial and cleaning.

[0048] In this embodiment, the proportions of each component were precisely optimized: Sodium lauryl ether sulfate and cocamidopropyl betaine were selected, and sodium dodecyl sulfate was used in combination to control the mass ratio of sodium lauryl ether sulfate, cocamidopropyl betaine and sodium dodecyl sulfate to 7:3:1.5, which effectively balanced the cleaning power and moisturizing properties, and avoided the problems that may exist in the prior art: insufficient cleaning power leading to difficult removal of residues; or excessive cleaning leading to damage to the protective film on the surface of medical devices.

[0049] Meanwhile, this embodiment also controls the mass ratio of propylene glycol to PEG-400 to 2:3 to ensure the stability and long-lasting effect of the protective film on the surface of medical devices. However, this may lead to corrosion of the metal parts of medical devices when stored in a humid environment. In this embodiment, by adding diethylenetriaminepentamethylphosphonic acid and controlling the mass ratio of diethylenetriaminepentamethylphosphonic acid to the total mass of propylene glycol and PEG-400 to 0.12:1, the anti-rust effect is precisely improved, achieving a balance between moisturizing and anti-rust.

[0050] In this embodiment, the process parameters were controlled: By employing a two-stage temperature control method of "dissolving at 80℃ and compounding at 40℃", the activity of protease and the stability of antibacterial components are avoided from being damaged by high temperature.

[0051] A stirring speed of 100 rpm ensures uniform mixing of components, avoiding defects such as stratification, sedimentation, and poor stability.

[0052] By using a 12-hour settling period and a 400-mesh filtration process, the product uniformity is improved, preventing tiny particles from affecting the performance.

[0053] In summary, this embodiment integrates four core functions—antibacterial, moisturizing, rust prevention, and cleaning—into a single formula, eliminating the need for multiple additional care products, simplifying clinical procedures, and enabling its wide range of applications.

[0054] Example 2 The difference between this comparative example and Example 1 is that, in the preparation of phase A: 5 parts of sodium lauryl ether sulfate, 1 part of cocamidopropyl betaine, 1 part of sodium dodecyl sulfate, 3 parts of PEG-400, and 0.25 parts of triclosan were added to 87.08 parts of deionized water to obtain a first mixture. The mixture was heated to 80°C and stirred at 100 rpm until all components were completely dissolved, forming a uniform and transparent phase A.

[0055] With all other conditions remaining unchanged, we obtain medical device moisturizer B.

[0056] Example 3 The difference between this comparative example and Example 1 is that, in the preparation of phase A: 10 parts of sodium lauryl ether sulfate, 4 parts of cocamidopropyl betaine, 3 parts of sodium dodecyl sulfate, 3 parts of PEG-400, and 0.25 parts of triclosan were added to 77.08 parts of deionized water to obtain a first mixture. The mixture was heated to 80°C and stirred at 100 rpm until all components were completely dissolved, forming a uniform and transparent phase A.

[0057] With all other conditions remaining unchanged, we obtain medical device moisturizer C.

[0058] Example 4 The difference between this comparative example and Example 1 is that the first mixture was heated to 80°C during the preparation of phase A, and the temperature of phase A was reduced to 60°C during the cooling process.

[0059] With all other conditions remaining unchanged, we obtain medical device moisturizer D.

[0060] Example 5 The difference between this comparative example and Example 1 is that the first mixture was heated to 70°C during the preparation of phase A, and the temperature of phase A was reduced to 60°C during the cooling process.

[0061] With all other conditions remaining unchanged, we obtain medical device moisturizer E.

[0062] Example 6 The difference between this comparative example and Example 1 is that, during the compounding process, 2 parts of diethylenetriaminepentamethylphosphonic acid, 0.6 parts of propylene glycol, 0.05 parts of methylisothiazolinone, and 0.02 parts of alkaline protease were added sequentially to the cooled A phase, and stirred for 20 minutes until all components were fully mixed and homogeneous to obtain phase B.

[0063] With all other conditions remaining unchanged, we obtain medical device moisturizer F.

[0064] Comparative Example 1 This comparative example discloses a method for preparing humectant A, which specifically includes the following steps: Take 5 parts of cocamidopropyl betaine, 3 parts of propylene glycol, 0.5 parts of rust inhibitor, and 91.5 parts of deionized water, and mix them evenly at room temperature to obtain humectant A.

[0065] Comparative Example 2 This comparative example discloses a method for preparing humectant B, which specifically includes the following steps: Take 6 parts sodium lauryl ether sulfate, 4 parts PEG-400, and 90 parts water, and mix them evenly at room temperature to obtain humectant B.

[0066] The present invention is based on the experiments conducted in Example 1 and Comparative Example 1 and Comparative Example 2 described above.

[0067] Experimental conditions: Experimental equipment: 10 pairs each of commonly used carbon steel surgical scissors and stainless steel hemostatic forceps, which are prepared for use after standardized cleaning.

[0068] Pathogenic bacterial strains: Escherichia coli (ATCC 25922), Staphylococcus aureus (ATCC 29213), and Candida albicans (ATCC 10231).

[0069] Experimental environment: temperature 25℃±2℃, humidity 85%±5%.

[0070] Testing standards: Antibacterial rate was tested according to GB 15979-2002 "Hygienic Standard for Disposable Sanitary Products". Rust prevention duration was determined by observing the time the instrument remained rust-free under humid conditions. Protein residue removal rate was tested using spectrophotometry. Product stability was determined by observing changes in appearance after 12 months of storage at room temperature. Skin irritation was tested on rabbits according to GB / T 16886.10.

[0071]

[0072] Based on the above experimental data, it can be seen that, compared with Comparative Example 1 and Comparative Example 2, Embodiment 1 of the present invention has the following beneficial effects: Significant antibacterial effect: According to GB 15979 standard testing, the 24-hour antibacterial rate of this invention against Escherichia coli, Staphylococcus aureus and Candida albicans reached 99.8%, 99.7% and 99.5% respectively, which is more than 17% higher than that of comparative example 1 and comparative example 2 (antibacterial rate below 85%). The antibacterial effect lasts for a long time and effectively reduces the risk of cross-infection.

[0073] Excellent rust prevention performance: In a humid environment with a temperature of 25℃ and a humidity of 85%, the medical carbon steel instruments in Examples 1, 2, and 3 showed no rust after being immersed in this product and stored for 168 hours. The rust prevention time corresponding to Comparative Examples 1 and 2 was only 48-72 hours. The rust prevention time of Example 1 of this invention is increased by more than 133%, which can better extend the service life of medical instruments.

[0074] Synergistic Cleaning and Moisturizing: The synergistic effect of protease and surfactant achieves a 99.2% removal rate of protein residues on the surface of instruments. At the same time, the moisturizing film formed by propylene glycol and PEG-400 can maintain the appropriate moisture content of the instrument surface. After 7 days of storage, there is no drying or cracking, thus resolving the contradiction between cleaning and moisturizing in existing products.

[0075] The product exhibits strong stability: after 12 months of storage at room temperature, the product showed no layering or sedimentation, and remained uniformly transparent in appearance, extending its shelf life by more than 50% compared to the existing product's 6-8 months.

[0076] High safety: All raw materials meet medical-grade standards. The product has a pH value of 6.5~7.5, which is close to the pH value of human skin. It has been verified by GB / T 16886.10 rabbit skin irritation test to be non-irritating and non-corrosive to medical devices.

[0077] In summary, the medical device moisturizer obtained in Embodiment 1 of the present invention has significantly improved in terms of antibacterial rate, rust prevention duration, cleaning effect, stability and safety.

[0078] In this invention, the 24-hour antibacterial rate in Examples 2 and 3 was significantly improved compared to Comparative Examples 1 and 2. The main antibacterial components, triclosan and methylisothiazolinone, remained unchanged and still exhibited good broad-spectrum and long-lasting antibacterial effects. However, the mass ratio of sodium lauryl ether sulfate, cocamidopropyl betaine, and sodium lauryl sulfate was not optimal, resulting in a weaker balance between cleansing and moisturizing effects. Therefore, the overall effect was slightly lower than that of Example 1.

[0079] In Embodiment 1 of this invention, a two-stage temperature control process of 80°C high-temperature dissolution and 40°C low-temperature compounding is employed. The 80°C high-temperature dissolution step is primarily used to ensure the complete dissolution of sodium lauryl ether sulfate, cocamidopropyl betaine, and sodium dodecyl sulfate, thereby forming a uniform and transparent A phase, improving product stability, and preventing stratification during long-term storage. The 40°C low-temperature step strictly controls the low temperature to protect components that are more sensitive to high temperatures. In the system of this invention, this is mainly to ensure that the alkaline protease is in an optimal activity temperature environment, preventing thermal denaturation and inactivation of its spatial structure, thus ensuring the enzymatic cleaning ability of the alkaline protease. Simultaneously, the two-stage temperature control process also prevents the thermal decomposition of triclosan and methylisothiazolinone, maintaining the long-lasting efficacy of the dual antibacterial system.

[0080] In Examples 4 and 5 of this invention, the specific temperature during the preparation process was adjusted, which to some extent disrupted the synergistic balance of the system in Examples 4 and 5, resulting in a slight decrease in the dual antibacterial effect. Due to the change in temperature in the low-temperature section, some proteases underwent thermal denaturation and inactivation, leading to a significant decrease in the protein residue removal rate and a reduction in cleaning efficiency. At the same time, due to the temperature adjustment in the high-temperature section in Example 5, the product stability of Example 5 also decreased slightly. Although the appearance remained uniform and transparent, slight layering occurred.

[0081] In Example 6 of the present invention, the mass ratio of diethylenetriaminepentamethylenephosphonic acid and propylene glycol was adjusted. The uniformity of dissolution of diethylenetriaminepentamethylenephosphonic acid in the system decreased, and some metal ions could not be fully chelated during use, thus the rust prevention effect was reduced to a certain extent.

[0082] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within the present invention.

[0083] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A medical device moisturizer, characterized by, By weight parts, including the following components: The first anionic surfactant 5~10 parts; Zwitterionic surfactant 1~4 parts; The second anionic surfactant 1~3 parts; Polyol moisturizing agent 2~5 parts; The first bacteriostatic agent 0.10~0.30 parts; Organic phosphonic acid type rust inhibitor 0.1~0.4 parts; Small molecule polyol moisturizing agent 1~4 parts; The second bacteriostatic agent 0.01~0.08 parts; Protease 0.005~0.03 parts; The rest is deionized water.

2. The medical device moisturizer according to claim 1, characterized in that: The first anionic surfactant is selected from sodium lauryl ether sulfate, the zwitterionic surfactant is selected from cocamidopropyl betaine, and the second anionic surfactant is selected from sodium dodecyl sulfate, The mass ratio of sodium lauryl ether sulfate and cocamidopropyl betaine is 7:(2~4).

3. The medical device moisturizer according to claim 1, characterized in that: The first bacteriostatic agent is selected from triclosan, and the second bacteriostatic agent is selected from methyl isothiazolinone, The mass ratio of triclosan and methyl isothiazolinone is (4~6):

1.

4. The medical device moisturizer according to claim 1, characterized in that: The polyol moisturizing agent is selected from polyethylene glycol, and the average molecular weight of the polyethylene glycol is 200~400g / mol.

5. The medical device moisturizer according to claim 4, characterized in that: The organic phosphonic acid type rust inhibitor is selected from diethylene triamine penta methylene phosphonic acid, and the small molecule polyol moisturizing agent is selected from at least one of propylene glycol, 1,3-propanediol or butanediol.

6. The medical device moisturizer according to claim 1, characterized in that: The mass ratio of the small molecule polyol moisturizing agent to the polyol moisturizing agent is 1:(1~2).

7. A method of preparing a medical device moisturizer, characterized by, Including the following steps: Take the first anionic surfactant 5~10 parts, zwitterionic surfactant 1~4 parts, second anionic surfactant 1~3 parts, polyol moisturizing agent 2~5 parts and first bacteriostatic agent 0.10~0.30 parts, add them into deionized water to get the first mixed solution, heat and stir the first mixed solution until all components are completely dissolved to form a uniform transparent A phase; The temperature of the A phase is reduced to 30~40℃ to get the cooled A phase; To the cooled A phase, add organic phosphonic acid type rust inhibitor 0.1~0.4 parts, small molecule polyol moisturizing agent 1~4 parts, second bacteriostatic agent 0.01~0.08 parts and protease 0.005~0.03 parts in turn, stir for 10~20 minutes to get B phase; The B phase is placed, filtered and the micro-particle impurities are removed to get the medical device moisturizer.

8. The preparation method of the medical device moisturizer according to claim 7, characterized in that: When heating and stirring the first mixed solution until all components are completely dissolved, the heating temperature is 70~80℃.

9. The preparation method of the medical device moisturizer according to claim 7, characterized in that: Heating and stirring the first mixture to complete dissolution of the components, the stirring time is 40-60 minutes, the stirring speed is 80-120 rpm.

10. The method of claim 7, wherein the medical device moisturizer is prepared by: The B phase is allowed to stand and filter, the standing time is at least 12 hours, and the filter screen used is not less than 400 meshes.

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