A medical instrument cleaning agent, a preparation method and application thereof

Through the synergistic effect of complex enzymes and deep eutectic solvents, the problem of existing medical device cleaning agents being unsatisfactory in removing biofilms is solved, and efficient removal of biofilms is achieved.

CN119391490BActive Publication Date: 2025-10-17GUANGYUAN CENT HOSPITAL
View PDF 4 Cites 0 Cited by

Patent Information

Application Number
CN202411415609.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-10-11
Publication Date
2025-10-17
Estimated Expiration
2044-10-11

AI Technical Summary

Technical Problem

Existing medical device cleaning agents are not ideal in removing biofilms, especially their ability to remove biofilms is insufficient.

Method used

The synergistic effect of the complex enzyme and the deep eutectic solvent is adopted. The deep eutectic solvent improves the penetration power, so that the complex enzyme can penetrate the biofilm more effectively and completely remove the biofilm.

Benefits of technology

It significantly improves the removal efficiency of biofilm, ensures the cleaning effect of other impurities, and effectively removes the adhered biofilm.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN119391490B_ABST
    Figure CN119391490B_ABST
Patent Text Reader

Abstract

The application discloses a medical instrument cleaning agent and a preparation method and application thereof, and belongs to the technical field of cleaning agents, and solves the problem of unsatisfactory biofilm removal effect of the medical instrument cleaning agent in the prior art. The medical instrument cleaning agent comprises the following components in parts by weight: 1-10 parts of a composite enzyme, 1-5 parts of a deep eutectic solvent, 10-20 parts of a surfactant, 0.01-0.5 parts of a preservative, 1-5 parts of propylene glycol, 1-5 parts of ethanol, 0.5-3 parts of a pH regulator, and a certain amount of water; wherein the deep eutectic solvent is composed of a hydrogen bond donor and a hydrogen bond acceptor. The medical instrument cleaning agent provided by the application can efficiently clean medical instruments and remove biofilm adhesion on the medical instruments, and has a good application effect.
Need to check novelty before this filing date? Find Prior Art

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of cleaning agents, more particularly to a medical instrument cleaning agent, a preparation method and application thereof. BACKGROUND

[0002] Cleaning is an important link in the disinfection procedure of medical instruments, and qualified cleaning agents are the guarantee of good disinfection effect. Chemical cleaning agents and multi-enzyme cleaning agents are mainly used for cleaning medical instruments. The cleaning effect of chemical cleaning agents is poor, and they can corrode instruments, so they have been basically eliminated. Multi-enzyme cleaning agents are currently a commonly used cleaning method.

[0003] In the prior art, multi-enzyme cleaning agents are often used to clean medical instruments. They contain multiple enzyme substances, which can effectively remove stains, proteins, bloodstains and other substances. However, the cleaning effect of multi-enzyme cleaning agents on biofilms is still not ideal. Many human bacterial infections are related to biofilms, so it is particularly important to improve the removal ability of medical instrument cleaning agents on biofilms. SUMMARY

[0004] The present application provides a medical instrument cleaning agent, a preparation method and application thereof, to solve the problem of unsatisfactory cleaning effect of medical instrument cleaning agents on biofilms in the prior art.

[0005] In a first aspect, the present application provides a medical instrument cleaning agent, which comprises the following components by weight: 1-10 parts of a composite enzyme, 1-5 parts of a deep eutectic solvent, 10-20 parts of a surfactant, 0.01-0.5 parts of a preservative, 1-5 parts of propylene glycol, 1-5 parts of ethanol, 0.5-3 parts of a pH adjuster, and a certain amount of water; wherein the deep eutectic solvent is composed of a hydrogen bond donor and a hydrogen bond acceptor.

[0006] As a possible implementation manner, the hydrogen bond donor is choline chloride; and / or, the hydrogen bond acceptor is any one of malic acid and xylitol.

[0007] As a possible implementation manner, the preparation of the deep eutectic solvent comprises the following steps: mixing the hydrogen bond donor and the hydrogen bond acceptor in a molar ratio of 1:0.5-1.0, stirring at a constant temperature of 80-90℃ until transparent, to obtain the deep eutectic solvent.

[0008] As a possible implementation manner, the composite enzyme is one or a combination of several of protease, lipase, cellulase and amylase; and / or, the surfactant is one or a combination of several of alkylphenol polyoxyethylene ether, fatty alcohol polyoxyethylene ether, alkyl alcohol amide and polyoxyethylene amide; and / or, the preservative is one or a combination of several of carzone, potassium citrate and nitrite; and / or, the pH adjuster is citric acid, EDTA, sodium bicarbonate and disodium hydrogen phosphate.

[0009] As a possible implementation manner, the complex enzyme is a combination of protease, lipase, cellulase and amylase; the surfactant is alkyl phenol polyoxyethylene ether; the preservative is potassium citrate; and the pH regulator is disodium hydrogen phosphate.

[0010] As a possible implementation manner, the mass content of the water in the medical instrument cleaning agent is 15-25%.

[0011] In a second aspect, the present application provides a preparation method of the medical instrument cleaning agent, comprising the following steps: mixing the raw material components in proportion according to the formula components contained in the medical instrument cleaning agent according to any possible implementation manner of the first aspect, and stirring uniformly to obtain the medical instrument cleaning agent.

[0012] In a third aspect, the present application provides an application of the medical instrument cleaning agent according to any possible implementation manner of the first aspect or the medical instrument cleaning agent prepared by the preparation method according to any possible implementation manner of the second aspect in cleaning medical instruments.

[0013] As a possible implementation manner, the medical instrument cleaning agent is used for removing bacterial biofilm.

[0014] As a possible implementation manner, the bacteria are Escherichia coli and / or Staphylococcus aureus.

[0015] The medical instrument cleaning agent provided by the present application uses deep eutectic solvent as the main active component for removing biofilm, can improve the penetration force, penetrate the biofilm, make the complex enzyme play a better role, and improve the removal ability and removal effect on the biofilm.

[0016] The preparation method of the medical instrument cleaning agent provided by the present application has simple operation steps, low raw material cost, and is easy to industrialize, and has the potential for further popularization and application; and the raw materials used are non-toxic, harmless and green.

[0017] The application of the medical instrument cleaning agent provided by the present application has a remarkable effect on removing bacterial biofilm, and the deep eutectic solvent and the complex enzyme synergistically act to efficiently remove the adhered biofilm while ensuring the cleaning effect of other impurities. BRIEF DESCRIPTION OF DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiment or prior art description. Obviously, the drawings in the following description only some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor on the basis of these drawings.

[0019] Figure 1 A contrast diagram of cleaning effects of different cleaning agents provided by the embodiment of the present application is shown. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be clearly and completely described in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the protection scope of the present application.

[0021] To solve the problem of unsatisfactory biofilm removal effect of the medical instrument cleaning agent in the prior art, the embodiment of the present application provides a preparation experiment of a medical instrument cleaning agent and a test experiment of biofilm removal effect.

[0022] Biofilm is composed of phospholipid molecules and proteins, and the proteins are mainly distributed on the surface of the membrane, which can be combined with the membrane in different ways. Enzyme-containing cleaning agents can only remove small molecular pollutants such as proteins on the surface of the membrane, and cannot completely destroy the biofilm. The medical instrument cleaning agent provided by the present application has a synergistic effect of complex enzyme and deep eutectic solvent, the complex enzyme removes the proteins outside the biofilm, and the deep eutectic solvent penetrates the biofilm, so that the complex enzyme can more effectively penetrate the biofilm, thereby achieving the purpose of completely removing the biofilm, and effectively eliminating bacteria and microorganisms.

[0023] Further, the embodiment of the present application provides an application experiment of the medical instrument cleaning agent for removing biofilm, and it can be known that in the actual application, the medical instrument cleaning agent provided by the present application has a synergistic effect of complex enzyme and deep eutectic solvent, which significantly improves the efficiency of removing biofilm, and effectively removes the adhered biofilm while ensuring the cleaning effect of other impurities.

[0024] The technical solutions of the present application will be further described in combination with specific embodiments.

[0025] Embodiment 1

[0026] The embodiment provides a preparation experiment of a medical instrument cleaning agent.

[0027] Protease 2g, lipase 1.5g, cellulase 1.5g, amylase 2g, alkylphenol polyoxyethylene ether 15g, potassium citrate 0.25g, propylene glycol 3g, ethanol 3g and disodium hydrogen phosphate 2.25g are mixed to obtain a mixture A, and the mixture A is mixed with 7.6g of water and stirred for 1h to obtain a cleaning agent A.

[0028] Choline chloride and malic acid were mixed in a mass ratio of 1:1, stirred at a constant temperature of 80℃ for 3h to obtain a clear and transparent liquid, which was deep eutectic solvent B; protease 2g, lipase 1.5g, cellulase 1.5g, amylase 2g, deep eutectic solvent B 3g, alkylphenol polyoxyethylene ether 15g, potassium citrate 0.25g, propylene glycol 3g, ethanol 3g and disodium hydrogen phosphate 2.25g were mixed to obtain mixture B, and the mixture B was mixed with 8.4g of water and stirred for 1h to obtain cleaner B.

[0029] Deep eutectic solvent B 3g, alkylphenol polyoxyethylene ether 15g, potassium citrate 0.25g, propylene glycol 3g, ethanol 3g and disodium hydrogen phosphate 2.25g were mixed to obtain mixture B', and the mixture B' was mixed with 6.6g of water and stirred for 1h to obtain cleaner B'.

[0030] Choline chloride and xylitol were mixed in a mass ratio of 1:1, stirred at a constant temperature of 90℃ for 3h to obtain a clear and transparent liquid, which was deep eutectic solvent C; protease 2g, lipase 1.5g, cellulase 1.5g, amylase 2g, deep eutectic solvent C 3g, alkylphenol polyoxyethylene ether 15g, potassium citrate 0.25g, propylene glycol 3g, ethanol 3g and disodium hydrogen phosphate 2.25g were mixed to obtain mixture C, and the mixture C was mixed with 8.4g of water and stirred for 1h to obtain cleaner C.

[0031] Deep eutectic solvent C 3g, alkylphenol polyoxyethylene ether 15g, potassium citrate 0.25g, propylene glycol 3g, ethanol 3g and disodium hydrogen phosphate 2.25g were mixed to obtain mixture C', and the mixture C' was mixed with 6.6g of water and stirred for 1h to obtain cleaner C'.

[0032] Example 2

[0033] The present embodiment provides a test experiment for removing biofilm of a medical instrument cleaner.

[0034] Biofilm culture: the experimental bacteria provided by the present embodiment are Escherichia coli (E.) and Staphylococcus aureus (S.), and the bacterial solution is newly recovered E. bacterial solution, S. bacterial solution, mixed bacterial solution of E. and S., with a concentration of 10 6 CFU / mL. The bacterial solution was added to the substrate (48-well plate with HF etching cell climbing sheet), and was placed in a 37℃, normal oxygen incubator for incubation; a micro-flow pump was used to maintain the culture medium (LB+1% glucose+10% FBS) in a dynamic state or was cultured by frequent liquid exchange (liquid was changed every 12h, and the supernatant was removed and replaced with culture medium), so that the bacterial blanket could not be easily blown away by the gun head, to obtain E. biofilm, S. biofilm and mixed E. and S. biofilm, which were used as the biofilm infection sources of experimental group 1, experimental group 2 and experimental group 3, respectively.

[0035] Biofilm infection: 48 clean vascular forceps were randomly and evenly divided into three groups, namely experimental group 1, experimental group 2 and experimental group 3. 1g of biofilm infection source was accurately applied at the elbow, hand and shaft joint of the vascular forceps respectively to ensure the consistency of the contaminated samples. After application, the samples were dried for 1h for standby; 15 of the 16 vascular forceps in each group were randomly and evenly divided into 5 subgroups, and the shaft joints were kept open and immersed in cleaning agent A, cleaning agent B, cleaning agent B', cleaning agent C and cleaning agent C' prepared in Example 1 respectively, and immersed in a constant temperature water bath at 40±2℃ for 10min; the other one in each group was used as a control group without cleaning agent treatment; after immersion, the vascular forceps were taken out, rinsed and rinsed with low-pressure flowing pure water, and dried in a hot air drying cabinet.

[0036] Result detection: The decontamination effect was detected by using the "luciferase-luciferin system". ATP sampling swabs were used to evenly wipe the shaft joints, tooth grooves and other surfaces of the sampled vascular forceps, and then the sampling swabs were quickly returned to the sampling tube until the tail end of the sampling swab was completely pressed into the sampling tube. Shake the sampling tube to fully soak and elute the monitoring liquid in the sampling tube to the sampling part. After turning on the power of the ATP fluorescence tester and completing the self-checking of the equipment, insert the sampling tube into the detection hole of the ATP tester, and read the ATP value displayed on the monitor. (Principle: Based on the principle of firefly light, the "luciferase-luciferin system" is used to quickly detect adenosine triphosphate (ATP). This detection method uses the fact that all living cells contain a constant amount of ATP, and by detecting the content of ATP (the lower the ATP value, the better the removal effect), it can clearly indicate the amount of bacteria and other biological residues in the sample, so as to judge the biofilm removal effect of the multi-enzyme cleaning agent of each example. ) The results are shown in Table 1.

[0037] Table 1 Results of cleaning biofilm-infected vascular forceps with different cleaning agents

[0038]

[0039] As shown in Table 1, under the conditions of E. coli, S. aureus and mixed bacteria infection of E. coli and S. aureus, the removal effect of biofilm of cleaning agent B and cleaning agent C was significantly better than that of cleaning agent A, and significantly better than that of cleaning agent B' and cleaning agent C'.

[0040] The biological membrane is composed of phospholipid molecules and proteins, and the proteins are mainly distributed on the surface of the membrane, which can be combined with the membrane in different ways. The enzyme-containing cleaning agent can only remove small molecular pollutants such as proteins on the surface of the membrane, and cannot completely destroy the biological membrane. The medical device cleaning agent provided by the application has the synergistic effect of complex enzymes and deep eutectic solvent, the complex enzymes remove the proteins outside the biological membrane, the deep eutectic solvent penetrates the biological membrane, so that the complex enzymes can penetrate the biological membrane more effectively, so as to completely remove the biological membrane, and then effectively eliminate bacteria and microorganisms.

[0041] Example 3

[0042] The present embodiment provides an application experiment of a medical device cleaning agent for removing biological membrane.

[0043] Randomly select 16 pieces of blood vessel forceps contaminated by dried sheep blood, and randomly divide 15 pieces into 3 groups, keep the joint open state, and respectively immerse in cleaning agent A, cleaning agent B, cleaning agent B', cleaning agent C and cleaning agent C' prepared in Example 1, immerse in a constant temperature water bath box at a temperature of 40±2℃ for 10min; another piece is used as a control group without cleaning agent treatment; after the immersion is completed, the blood vessel forceps are taken out, washed and rinsed with low-pressure flowing pure water, dried in a hot air drying cabinet, and then the decontamination effect is detected by using the luciferase-luciferin system shown in Example 2. The results shown in Table 2 and Figure 1 .

[0044] Table 2 ATP value detection results of blood vessel forceps after cleaning with different cleaning agents

[0045]

[0046] As can be seen from Table 2 and Figure 1 , the removal effect of biological membrane of cleaning agent B and cleaning agent C is significantly better than that of cleaning agent A, and significantly better than that of cleaning agent B' and cleaning agent C'. In the medical device cleaning agent provided by the application, the synergistic effect of complex enzymes and deep eutectic solvent significantly improves the efficiency of removing biological membrane, and effectively removes the adhered biological membrane while ensuring the cleaning effect of other impurities.

[0047] Although the preferred embodiments of the present application have been described, those skilled in the art can make further changes and modifications to these embodiments once they know the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications falling within the scope of the present application.

[0048] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the claims of the present application and their equivalents, the present application also intends to include these modifications and variations.

Claims

1. A medical device cleaning agent, characterized in that: The invention is composed of the following components: complex enzyme 7 g, deep eutectic solvent 3 g, surfactant 15 g, preservative 0.25 g, propylene glycol 3 g, ethanol 3 g, pH adjuster 2.25 g and water 8.4 g; The complex enzyme is a combination of 2g protease, 1.5g lipase, 1.5g cellulase and 2g amylase; The surfactant is alkylphenol polyoxyethylene ether; The preservative is potassium citrate; The pH regulator is disodium hydrogen phosphate; The deep eutectic solvent consists of choline chloride and malic acid in a molar ratio of 1:

1.

2. The medical device cleaning agent according to claim 1, characterized in that The preparation of the deep eutectic solvent comprises the following steps: The choline chloride and the malic acid are mixed in a molar ratio of 1:1, and stirred at a constant temperature of 80-90° C. until transparent to obtain the deep eutectic solvent.

3. A method for preparing a medical device cleaning agent, characterized in that: The following steps are involved: According to the formula components contained in the medical device cleaning agent according to claim 1 or 2, the raw material components are mixed in proportion and stirred evenly to obtain the medical device cleaning agent.

4. Use of the medical device cleaning agent according to claim 1 or 2 or the medical device cleaning agent prepared by the preparation method according to claim 3 in cleaning medical devices.

5. The use according to claim 4, characterized in that The medical device cleaning agent is used for removing bacterial biofilm.

6. The use according to claim 5, characterized in that The bacteria are Escherichia coli and / or Staphylococcus aureus.

Citation Information

Patent Citations

  • Multi-enzyme cleaning agent, preparation method and application thereof

    CN111349524A

  • Deep eutectic solvent for extracting heavy metals as well as preparation method and application of deep eutectic solvent

    CN118341116A

  • Composition for inhibition and removal of biofilm

    KR1020180056225A

  • Anti-limescale composition

    US20230348822A1