Medical instrument cleaning agent as well as preparation method and application thereof

Abstract

The invention discloses a medical instrument cleaning agent as well as a preparation method and application thereof, belongs to the technical field of cleaning agents, and solves the problem that a medical instrument cleaning agent in the prior art is not ideal in biological membrane removal effect. The medical instrument cleaning agent comprises the following components in parts by weight: 1-10 parts of compound enzyme, 1-5 parts of a deep eutectic solvent, 10-20 parts of a surfactant, 0.01-0.5 part 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 invention can efficiently clean medical instruments, can efficiently remove biological membrane adhesion on the medical instruments, and is relatively good in application effect.

Description

Technical Field

[0001] The present invention relates to the technical field of cleaning agents, and more specifically to a cleaning agent for medical devices and a preparation method and application thereof. Background Art

[0002] Cleaning is an important part of the disinfection process of medical devices, and qualified cleaning agents are the guarantee of good disinfection effects. Medical device cleaning mainly uses chemical cleaning agents and multi-enzyme cleaning agents. Chemical cleaning agents have poor cleaning effects and are corrosive to devices, and have been basically eliminated. Multi-enzyme cleaning agents are currently the more commonly used cleaning method.

[0003] In the prior art, multi-enzyme cleaning agents are often used to clean medical devices. They contain a variety of enzyme substances and can effectively remove stains, proteins, blood stains and other substances. However, the removal effect of multi-enzyme cleaning agents on biofilms is still not ideal. Many human bacterial infections are related to biofilms. Therefore, it is particularly important to improve the ability of medical device cleaning agents to remove biofilms. Summary of the invention

[0004] The present invention provides a medical device cleaning agent and a preparation method and application thereof, which are used to solve the problem that the medical device cleaning agent in the prior art has an unsatisfactory effect in removing biofilm.

[0005] In the first aspect, the present invention provides a medical device cleaning agent, comprising the following components by weight: 1 to 10 parts of complex enzyme, 1 to 5 parts of deep eutectic solvent, 10 to 20 parts of surfactant, 0.01 to 0.5 parts of preservative, 1 to 5 parts of propylene glycol, 1 to 5 parts of ethanol, 0.5 to 3 parts of pH adjuster, and some 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 method, the preparation of the deep eutectic solvent includes the following steps: mixing the hydrogen bond donor and the hydrogen bond acceptor in a molar ratio of 1:0.5 to 1.0, stirring at a constant temperature of 80 to 90° C. until transparent, to obtain the deep eutectic solvent.

[0008] As a possible implementation, the complex enzyme is one or a combination of proteases, lipases, cellulases, and amylases; and / or the surfactant is one or a combination of alkylphenol polyoxyethylene ethers, fatty alcohol polyoxyethylene ethers, alkyl alcohol amides, and polyoxyethylene amides; and / or the preservative is one or a combination of kasone, potassium citrate, and nitrite; and / or the pH adjuster is citric acid, EDTA, sodium bicarbonate, and disodium hydrogen phosphate.

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

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

[0011] In a second aspect, the present invention provides a method for preparing a medical device cleaning agent, comprising the following steps: mixing the raw material components in proportion according to the formula components contained in the medical device cleaning agent described in any possible implementation method of the first aspect, stirring evenly, to obtain the medical device cleaning agent.

[0012] In a third aspect, the present invention provides a use of the medical device cleaning agent described in any possible implementation of the first aspect or the medical device cleaning agent prepared by the preparation method described in any possible implementation of the second aspect in cleaning medical devices.

[0013] As a possible implementation manner, the medical device cleaning agent is used to remove bacterial biofilm.

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

[0015] The medical device cleaning agent provided by the present invention uses a deep eutectic solvent as the main active component for removing biofilms, which can improve the permeability, penetrate the biofilm, enable the complex enzyme to play a better role, and improve the biofilm removal ability and removal effect.

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

[0017] The use of the medical device cleaning agent provided by the present invention has a significant effect in removing bacterial biofilms. The deep eutectic solvent and the complex enzyme work synergistically to efficiently remove adhered biofilms while ensuring the cleaning effect of other impurities. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0019] Figure 1 A schematic diagram comparing the cleaning effects of different cleaning agents provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] In order to solve the problem that the medical device cleaning agent in the prior art is not effective in removing biofilm, the embodiment of the present invention provides a preparation experiment of a medical device cleaning agent and conducts a test experiment on the biofilm removal effect.

[0022] Biomembranes are composed of phospholipid molecules and proteins. Proteins are mainly distributed on the membrane surface and can bind to the membrane in different ways. Enzyme-containing cleaning agents can only remove small molecular pollutants such as proteins on the membrane surface, but cannot completely destroy the biomembrane. In the medical device cleaning agent provided by the present invention, the composite enzyme and the deep eutectic solvent work synergistically. The composite enzyme removes proteins outside the biomembrane, and the deep eutectic solvent penetrates the biomembrane, so that the composite enzyme can penetrate the biomembrane more effectively, so as to achieve the purpose of completely removing the biomembrane, thereby effectively eliminating bacteria and microorganisms.

[0023] Furthermore, an embodiment of the present invention provides an application experiment of medical device cleaning agents for removing biofilms. It can be seen that in actual application scenarios, in the medical device cleaning agents provided by the present invention, the complex enzyme and the deep eutectic solvent work synergistically to significantly improve the efficiency of removing biofilms, while ensuring the cleaning effect of other impurities, the adhered biofilm is efficiently removed.

[0024] The technical solution of the present invention will be further described below in conjunction with specific embodiments.

[0025] Example 1

[0026] This embodiment provides an experiment for preparing a medical device cleaning agent.

[0027] Mix 2 g of protease, 1.5 g of lipase, 1.5 g of cellulase, 2 g of amylase, 15 g of alkylphenol polyoxyethylene ether, 0.25 g of potassium citrate, 3 g of propylene glycol, 3 g of ethanol and 2.25 g of disodium hydrogen phosphate to obtain mixture A, mix mixture A with 7.6 g of water and stir for 1 hour to obtain cleaning agent A.

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

[0029] Mix 3 g of deep eutectic solvent B, 15 g of alkylphenol polyoxyethylene ether, 0.25 g of potassium citrate, 3 g of propylene glycol, 3 g of ethanol and 2.25 g of disodium hydrogen phosphate to obtain mixture B', and mix mixture B' with 6.6 g of water and stir for 1 hour to obtain cleaning agent B'.

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

[0031] Mix 3 g of deep eutectic solvent C, 15 g of alkylphenol polyoxyethylene ether, 0.25 g of potassium citrate, 3 g of propylene glycol, 3 g of ethanol and 2.25 g of disodium hydrogen phosphate to obtain mixture C', and mix mixture C' with 6.6 g of water and stir for 1 hour to obtain cleaning agent C'.

[0032] Example 2

[0033] This embodiment provides a test experiment for removing biofilm using a medical device cleaning agent.

[0034] Biofilm culture: The experimental bacteria provided in this example are Escherichia coli (E.) and Staphylococcus aureus (S.), and the bacterial solution is a newly revived E. bacterial solution, S. bacterial solution, or a mixed bacterial solution of E. and S., with a concentration of 10 6 CFU / mL. The bacterial solution was added to the substrate (a 48-well plate with HF-etched cell slides) and incubated in a 37°C, normoxic incubator; a microfluidic pump was used to maintain the culture medium (LB+1% glucose+10% FBS) in a dynamic state or the culture medium was frequently changed (the liquid was changed every 12 hours, and the supernatant was sucked out and the culture medium was changed) until the bacterial blanket was not easily blown away by the gun tip, and E. biofilm, S. biofilm, and E. and S. mixed biofilm were obtained as the biofilm infection sources of experimental group 1, experimental group 2, and experimental group 3, respectively.

[0035] Biofilm infection: 48 clean vascular clamps were randomly divided into 3 groups, namely Experimental Group 1, Experimental Group 2 and Experimental Group 3. 1g of biofilm infection source was accurately applied to the elbow, handgrip and shaft joint of the vascular clamp to ensure the consistency of the contaminated sample. After application, it was dried for 1 hour for use; 15 of the 16 vascular clamps in each group were randomly divided into 5 small groups, and the shaft joints were kept open and immersed in the 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; another one of the 16 vascular clamps in each group was used as a control group without cleaning agent treatment; after the immersion, the vascular clamp was 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 is detected by using the "luciferase-luciferin system". The ATP sampling swab is used to evenly wipe the shaft joint, tooth groove and other surfaces of the sampled vascular clamp, and then the sampling swab is quickly put back into the sampling tube until the tail end of the sampling swab is completely pressed into the sampling tube. The sampling tube is shaken to allow the monitoring liquid in the sampling tube to fully soak and elute the swab sampling part. After turning on the power of the ATP fluorescence tester and completing the equipment self-test, the sampling tube is inserted into the detection hole of the ATP tester to read the ATP value displayed on the monitor. (Principle: Based on the principle of firefly luminescence, the "luciferase-luciferin system" is used to quickly detect adenosine triphosphate (ATP). This detection method uses the fact that all living biological cells contain a constant amount of ATP. By detecting the ATP content (the lower the ATP value, the better the removal effect), it is clearly indicated how much bacteria and other biological residues are in the sample, so as to judge the biofilm removal effect of the multi-enzyme cleaning agent of each embodiment.) The results shown in Table 1 are obtained.

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

[0038]

[0039] As shown in Table 1, in the case of Escherichia coli, Staphylococcus aureus and mixed bacterial infection of Escherichia coli and Staphylococcus aureus, the removal effect of the biofilm by detergent B and detergent C was significantly better than that of detergent A, and was also significantly better than detergent B' and detergent C'.

[0040] Biomembranes are composed of phospholipid molecules and proteins. Proteins are mainly distributed on the membrane surface and can bind to the membrane in different ways. Enzyme-containing cleaning agents can only remove small molecular pollutants such as proteins on the membrane surface, but cannot completely destroy the biomembrane. In the medical device cleaning agent provided by the present invention, the composite enzyme and the deep eutectic solvent work synergistically. The composite enzyme removes proteins outside the biomembrane, and the deep eutectic solvent penetrates the biomembrane, so that the composite enzyme can penetrate the biomembrane more effectively, so as to achieve the purpose of completely removing the biomembrane, thereby effectively eliminating bacteria and microorganisms.

[0041] Example 3

[0042] This embodiment provides an application experiment of a medical device cleaning agent in removing biofilm.

[0043] 16 dried vascular clamps contaminated by sheep blood were randomly selected, of which 15 were randomly divided into 3 groups, and kept the shaft joints open and immersed in the 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°C for 10 minutes; the other one was used as a control group without cleaning agent treatment; after the immersion, the vascular clamps were taken out, rinsed and rinsed with low-pressure flowing pure water, dried in a hot air drying cabinet, and then the decontamination effect was detected using the "luciferase-luciferin system" shown in Example 2. The results are shown in Table 2 and Figure 1 Results shown.

[0044] Table 2 ATP value test results of vascular clamps after cleaning with different cleaning agents

[0045]

[0046] From Table 2 and Figure 1 It can be seen that the removal effect of cleaning agent B and cleaning agent C on biofilm is significantly better than that of cleaning agent A, and is also significantly better than that of cleaning agent B' and cleaning agent C'. In the medical device cleaning agent provided by the present invention, the composite enzyme and the deep eutectic solvent work synergistically, significantly improving the efficiency of removing biofilm, and efficiently removing the adhered biofilm while ensuring the cleaning effect of other impurities.

[0047] Although the preferred embodiments of the present invention have been described, those skilled in the art may make other changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

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

Claims

1. A medical device cleaning agent, characterized in that: The components include the following by weight: 1-10 parts of complex enzyme, 1-5 parts of deep eutectic solvent, 10-20 parts of surfactant, 0.01-0.5 parts of preservative, 1-5 parts of propylene glycol, 1-5 parts of ethanol, 0.5-3 parts of pH regulator, and some water; Wherein, the deep eutectic solvent consists of a hydrogen bond donor and a hydrogen bond acceptor.

2. The medical device cleaning agent according to claim 1, characterized in that: The hydrogen bond donor is choline chloride; And / or, the hydrogen bond acceptor is any one of malic acid and xylitol.

3. The medical device cleaning agent according to any one of claims 1 to 2, characterized in that: The preparation of the deep eutectic solvent comprises the following steps: The hydrogen bond donor and the hydrogen bond acceptor are mixed at a molar ratio of 1:0.5 to 1.0, and stirred at a constant temperature of 80 to 90° C. until transparent to obtain the deep eutectic solvent.

4. The medical device cleaning agent according to claim 1, characterized in that: The complex enzyme is one or a combination of protease, lipase, cellulase and amylase; And / or, the surfactant is one or a combination of alkylphenol polyoxyethylene ether, fatty alcohol polyoxyethylene ether, alkyl alcohol amide and polyoxyethylene amide; And / or, the preservative is one or a combination of kasone, potassium citrate and nitrite; And / or, the pH adjuster is citric acid, EDTA, sodium bicarbonate and disodium hydrogen phosphate.

5. The medical device cleaning agent according to claim 4, characterized in that: The complex enzyme is a combination of protease, lipase, cellulase and amylase; The surfactant is alkylphenol polyoxyethylene ether; The preservative is potassium citrate; The pH regulator is disodium hydrogen phosphate.

6. The medical device cleaning agent according to claim 1, characterized in that: The mass content of the water in the medical device cleaning agent is 15% to 25%.

7. A method for preparing a medical device cleaning agent, characterized in that: The following steps are involved: The raw material components are mixed according to the formula components contained in the medical device cleaning agent according to any one of claims 1 to 6 in proportion, and stirred evenly to obtain the medical device cleaning agent.

8. Use of the medical device cleaning agent according to any one of claims 1 to 6 or the medical device cleaning agent prepared by the preparation method according to claim 6 in cleaning medical devices.

9. The use according to claim 8, characterized in that: The medical device cleaning agent is used for removing bacterial biofilm.

10. The use according to claim 9, characterized in that: The bacteria are Escherichia coli and / or Staphylococcus aureus.

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