A peroxiacetic acid-based disinfectant for endoscope disinfection

Abstract

This invention relates to the field of medical disinfection technology, specifically to a peracetic acid-based disinfectant solution for endoscope disinfection, comprising the following components: peracetic acid, hydrogen peroxide, acetic acid, stabilizer, citric acid, decyl glucoside, benzotriazole, and deionized water. This invention provides a ready-to-use, single-component, highly stable, and low-corrosive peracetic acid-based disinfectant solution. By introducing a stabilizer composed of hydroxypropyl-β-cyclodextrin and 1,2-propanediol, synergistically with benzotriazole and decyl glucoside as corrosion inhibitors, the self-decomposition of peracetic acid is effectively inhibited, enhancing the stability of the disinfectant solution, significantly reducing its corrosiveness, minimizing the risk of corrosion to endoscope metal components, and further improving the safety and ease of use of the disinfectant solution.

Description

Technical Field

[0001] This invention relates to the field of medical disinfection technology, specifically to a peracetic acid-based disinfectant solution for disinfecting endoscopes. Background Technology

[0002] Endoscopes come into repeated contact with human cavities and fluids during clinical diagnosis and treatment. Due to their complex structure and narrow lumen, they require high levels of sterilization ability of disinfectants, material compatibility, and safety in use.

[0003] Peracetic acid is a high-level disinfectant that denatures proteins by oxidizing sulfhydryl groups and sulfur bonds, thereby disrupting cell wall permeability and affecting normal bacterial growth and reproduction. It is widely used for high-level disinfection of medical devices such as endoscopes due to its broad bactericidal spectrum, rapid action, and lack of drug resistance. However, existing peracetic acid disinfectants are mostly prepared on-site or through two-component mixing, resulting in cumbersome procedures, large concentration fluctuations, and insufficient safety. Furthermore, peracetic acid disinfectants have poor stability; to ensure their stability, strong acids or high concentrations of hydrogen peroxide are typically used as stabilizing systems, leading to highly corrosive disinfectants that can easily damage endoscope metal parts and polymer materials, and producing a strong, irritating odor, making them unsuitable for long-term clinical use.

[0004] Therefore, how to provide an endoscope disinfectant that is highly stable, low in corrosiveness, and easy to use while ensuring disinfection effectiveness remains a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a peracetic acid-based disinfectant for endoscopic disinfection.

[0006] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A peracetic acid-based disinfectant for endoscope disinfection comprises the following components: 0.25-0.40% (w / w) peracetic acid, 0.8-1.2% (w / w) hydrogen peroxide, 1.8-2.8% (w / w) acetic acid, 1.10-1.60% (w / w) stabilizer, 0.10-0.12% (w / w) citric acid, 0.10-0.12% (w / w) decyl glucoside, 0.02-0.03% (w / w) benzotriazole, with the balance being deionized water; The preparation method of the peracetic acid disinfectant includes the following steps: S1. Add acetic acid and hydrogen peroxide solution to the reaction vessel, stir and react for 30-60 min to obtain a pre-generated peracetic acid solution; S2. Add the pre-generated peracetic acid solution from step S1 to the stabilizer, control the addition time, and stir the reaction for 10-20 minutes; S3. Add benzotriazole and decyl glucoside to the solution obtained in step S2, stir for 5-10 min, add deionized water to make the final volume 100%, and let stand for 12-24 h to obtain the peracetic acid disinfectant solution. The stabilizer includes hydroxypropyl-β-cyclodextrin and 1,2-propanediol; The method for preparing the stabilizer includes the following steps: Add deionized water to the reaction vessel, making up 60% of the final volume, and add hydroxypropyl-β-cyclodextrin and 1,2-propanediol. Stir the reaction for 10-20 minutes, then add citric acid to adjust the pH of the system to 5.6-6.0 to obtain the stabilizer.

[0007] Furthermore, the mass ratio of the hydroxypropyl-β-cyclodextrin to 1,2-propanediol is 1:(4-8).

[0008] Furthermore, in step S2, the addition time is controlled to be 30-45 minutes.

[0009] The present invention also provides the application of peracetic acid disinfectant for endoscope disinfection.

[0010] This invention also provides the application of peracetic acid disinfectant for endoscope disinfection in the disinfection of medical devices.

[0011] This invention also provides the application of peracetic acid disinfectant for endoscope disinfection in the disinfection of metal products.

[0012] Compared with the prior art, the beneficial effects of the present invention are: The peracetic acid disinfectant solution prepared by this invention for endoscope disinfection effectively inhibits the self-decomposition of peracetic acid and improves its effective utilization rate by introducing a stabilizer composed of hydroxypropyl-β-cyclodextrin and 1,2-propanediol, thereby enhancing the stability of the disinfectant solution and maintaining good disinfection effect even at low peracetic acid content.

[0013] The peracetic acid disinfectant prepared in this invention also contains benzotriazole and decyl glucoside as corrosion inhibitors, which can reduce the corrosiveness of the disinfectant. Through the synergistic effect of the stabilizer system and the corrosion inhibitors, the corrosiveness of the system is significantly reduced while ensuring the disinfection effect, reducing the risk of corrosion to the metal parts of the endoscope, and further improving the safety and ease of use. This invention achieves a ready-to-use, single-component, highly stable, and low-corrosive peracetic acid disinfectant without the need for on-site generation of peracetic acid or the use of strong acid stabilizers. Attached Figure Description

[0014] Figure 1 This is a process flow diagram of the peracetic acid disinfectant solution used for endoscope disinfection according to the present invention. Detailed Implementation

[0015] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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.

[0016] Example 1: A peracetic acid disinfectant for endoscope disinfection, comprising the following components by mass concentration: 0.25% (w / w) peracetic acid, 0.80% (w / w) hydrogen peroxide, 1.80% (w / w) acetic acid, 1.10% (w / w) stabilizer, 0.10% (w / w) citric acid, 0.10% (w / w) decyl glucoside, 0.02% (w / w) benzotriazole, with the balance being deionized water.

[0017] 1. Preparation method of stabilizer Deionized water was added to the reaction vessel, accounting for 60% of the final volume. Hydroxypropyl-β-cyclodextrin was slowly added at 25°C and stirred at 300 rpm with a magnetic stirrer until the hydroxypropyl-β-cyclodextrin was completely dissolved. Then, 1,2-propanediol was slowly added while stirring at 150 rpm for 10 min. The mass ratio of hydroxypropyl-β-cyclodextrin to 1,2-propanediol was 1:4. Citric acid was added to adjust the pH of the system to 5.6 to obtain a homogeneous stabilizer.

[0018] 2. Preparation method of peracetic acid disinfectant S1. Add acetic acid solution to a separate reaction vessel and control the reaction temperature at 20°C. Then slowly add hydrogen peroxide solution and stir at 100 rpm for 30 min to obtain a pre-generated peracetic acid solution. S2. At 20°C, the pre-generated peracetic acid solution obtained in step S1 is slowly added to the stabilizer system, and the addition time is controlled to be 30 min. The mixture is stirred at 60 rpm for 10 min. S3. Add benzotriazole and decyl glucoside sequentially to the solution obtained in step S2, and stir at 60-100 rpm for 5-10 minutes to fully dissolve and disperse them. Add the remaining deionized water to make up the final volume to 100%, and then let it stand and mature for 12 hours in the dark to obtain the final product.

[0019] Example 2: A peracetic acid disinfectant for endoscope disinfection, comprising the following components by mass concentration: 0.30% (w / w) peracetic acid, 1.00% (w / w) hydrogen peroxide, 2.20% (w / w) acetic acid, 1.35% (w / w) stabilizer, 0.10% (w / w) citric acid, 0.10% (w / w) decyl glucoside, 0.02% (w / w) benzotriazole, with the balance being deionized water.

[0020] 1. Preparation method of stabilizer Deionized water was added to the reaction vessel, accounting for 60% of the final volume. Hydroxypropyl-β-cyclodextrin was slowly added at 25°C and stirred at 350 rpm with a magnetic stirrer until the hydroxypropyl-β-cyclodextrin was completely dissolved. Then, 1,2-propanediol was slowly added while stirring at 200 rpm for 15 min. The mass ratio of hydroxypropyl-β-cyclodextrin to 1,2-propanediol was 1:6. Citric acid was added to adjust the pH of the system to 5.8 to obtain the stabilizer.

[0021] 2. Preparation method of peracetic acid disinfectant S1. Add acetic acid solution to a separate reaction vessel and control the reaction temperature at 20°C. Then slowly add hydrogen peroxide solution and stir the reaction at 150 rpm for 45 min to obtain a pre-generated peracetic acid solution. S2. At 20°C, the pre-generated peracetic acid solution obtained in step S1 is slowly added to the stabilizer system, and the addition time is controlled to be 40 min. The mixture is stirred at 80 rpm for 15 min. S3. Add benzotriazole and decyl glucoside sequentially to the solution obtained in step S2, and stir at 80 rpm for 8 min to fully dissolve and disperse them. Add the remaining deionized water to make up the final volume to 100%, and then let it stand and mature for 18 h in the dark to obtain the final product.

[0022] Example 3: A peracetic acid disinfectant for endoscope disinfection, comprising the following components by mass concentration: 0.40% (w / w) peracetic acid, 1.20% (w / w) hydrogen peroxide, 2.80% (w / w) acetic acid, 1.60% (w / w) stabilizer, 0.12% (w / w) citric acid, 0.12% (w / w) decyl glucoside, 0.03% (w / w) benzotriazole, with the balance being deionized water.

[0023] 1. Preparation method of stabilizer Deionized water was added to the reaction vessel, accounting for 60% of the final volume. Hydroxypropyl-β-cyclodextrin was slowly added at 25°C and stirred at 400 rpm with a magnetic stirrer until the hydroxypropyl-β-cyclodextrin was completely dissolved. Then, 1,2-propanediol was slowly added while stirring at 200 rpm for 20 min. The mass ratio of hydroxypropyl-β-cyclodextrin to 1,2-propanediol was 1:8. Citric acid was added to adjust the pH of the system to 6.0 to obtain a homogeneous stabilizer.

[0024] 2. Preparation method of peracetic acid disinfectant S1. Add acetic acid solution to a separate reaction vessel and control the reaction temperature at 20°C. Then slowly add hydrogen peroxide solution and stir the reaction at 100 rpm for 60 min to obtain a pre-generated peracetic acid solution. S2. At 20°C, the pre-generated peracetic acid solution obtained in step S1 is slowly added to the stabilizer system, and the addition time is controlled to be 45 min. The reaction is carried out by stirring at 100 rpm for 20 min. S3. Add benzotriazole and decyl glucoside sequentially to the solution obtained in step S2, and stir at 100 rpm for 10 min to fully dissolve and disperse them. Add the remaining deionized water to make up the final volume to 100%, and then let it stand and mature for 24 h in the dark to obtain the final product.

[0025] Comparative Example 1: The difference between Comparative Example 1 and Example 1 is that in the preparation method of peracetic acid disinfectant, the stabilizer is sodium gluconate, while other conditions remain unchanged.

[0026] Comparative Example 2: Peracetic acid disinfectant and its preparation method as described in patent CN 113749094 B, and according to the components and preparation process listed in the patent, peracetic acid disinfectant was prepared.

[0027] Comparative Example 3: The difference between Comparative Example 3 and Example 1 is that benzotriazole is not added in the preparation method of peracetic acid disinfectant, while other conditions remain unchanged.

[0028] Comparative Example 4: The difference between Comparative Example 4 and Example 1 is that no stabilizer is added in the preparation method of the peracetic acid disinfectant. Benzotriazole and decyl glucoside are added sequentially to the pre-generated peracetic acid solution obtained in step S1, while other conditions remain unchanged.

[0029] Performance testing of peracetic acid disinfectant 1. Determination of peracetic acid content and disinfectant stability According to the method for determining the stability of disinfection products in the 2002 edition of the "Disinfection Technical Specifications", the peracetic acid content was determined and the stability of the disinfectant solution was tested. 500 mL of each group of disinfectant solutions described in Examples 1-3 and Comparative Examples 1-4 were prepared. During the experiment, each group of disinfectant solutions was placed in a constant temperature incubator at 37°C and stored for 3 months. The peracetic acid content was measured before and after storage.

[0030] Table 1. Changes in peracetic acid content in the disinfectants of the examples and comparative examples over 3 months. In the table, "--" indicates that it was not detected.

[0031] The results are shown in Table 1. Compared with the disinfectants prepared in Comparative Examples 1-4, the disinfectant solutions prepared in Examples 1-3 of this invention showed a significantly lower rate of decrease in peracetic acid content, indicating that the stabilizer composed of hydroxypropyl-β-cyclodextrin and 1,2-propanediol can significantly improve the stability of peracetic acid disinfectants. Meanwhile, the disinfectants prepared in Examples 1-3 all exhibited good stability during a 3-month storage period, meeting the requirement of ≤10% decrease in effective ingredient content in the 2002 edition of the "Disinfection Technical Specifications," indicating that the shelf life of the disinfectant prepared by this invention can be set at 2 years.

[0032] 2. Metal corrosion test Examples 1-3 and Comparative Examples 1-3 were tested according to the method for determining the corrosiveness of disinfectants to metals in the 2002 edition of the "Disinfection Technical Specifications".

[0033] Table 2 Metal corrosion rate (mm / a) The results are shown in Table 2. The disinfectant solutions prepared in Examples 1-3 of this invention all exhibited corrosion rates of less than 0.0100 mm / a on carbon steel, copper, aluminum, and stainless steel, indicating that they were essentially non-corrosive. This demonstrates that the disinfectant solutions prepared in Examples 1-3 have good corrosion inhibition properties for various metal materials. The corrosion rates of Comparative Examples 1 and 2 were in the range of 0.0100 to <0.100 mm / a, showing mild corrosivity and a significantly reduced corrosion inhibition effect. The corrosion rates of Comparative Examples 3 and 4 were generally close to 1.00 mm / a, with some metals even exceeding 1.00 mm / a, exhibiting moderate to severe corrosivity. In summary, the disinfectant solutions prepared in Examples 1-3 of this invention significantly reduced the corrosion rate on various metals, demonstrating good corrosion protection and making them suitable for efficient and safe disinfection of precision medical devices such as endoscopes.

[0034] 3. Sterilization performance test According to the "Technical Specifications for Testing the Disinfection Effect of Endoscope Cleaning and Disinfection Machines (Trial)" (Ministry of Health, 2003 Edition), experiments were conducted on the disinfectant solutions prepared in Examples 1-3 to simulate on-site tests of endoscope cleaning and disinfection machines.

[0035] Table 3. Results of bactericidal performance test The results are shown in Table 3. The disinfectant solutions prepared in Examples 1-3 all had a log reduction value of ≥3.00 against artificially contaminated Bacillus subtilis var. niger spores, which meets the relevant requirements of the "Technical Specifications for Disinfection Effect Testing of Endoscope Cleaning and Disinfection Machines (Trial)" (Ministry of Health, 2003 Edition), and the disinfection was qualified.

[0036] The peracetic acid disinfectant prepared by this invention can still produce a significant killing effect on highly resistant Bacillus subtilis var. niger spores even under conditions of low effective ingredient content, and has good bactericidal performance. It can meet the high-level disinfection requirements of precision medical devices such as endoscopes, and has good practical application value and promotion prospects.

[0037] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A peracetic acid-based disinfectant for endoscopic disinfection, characterized in that, It includes the following components: 0.25-0.40% (w / w) peracetic acid, 0.8-1.2% (w / w) hydrogen peroxide, 1.8-2.8% (w / w) acetic acid, 1.10-1.60% (w / w) stabilizer, 0.10-0.12% (w / w) citric acid, 0.10-0.12% (w / w) decyl glucoside, 0.02-0.03% (w / w) benzotriazole, with the balance being deionized water; The preparation method of the peracetic acid disinfectant includes the following steps: S1. Add acetic acid and hydrogen peroxide solution to the reaction vessel, stir and react for 30-60 min to obtain a pre-generated peracetic acid solution; S2. Add the pre-generated peracetic acid solution from step S1 to the stabilizer, control the addition time, and stir the reaction for 10-20 minutes; S3. Add benzotriazole and decyl glucoside to the solution obtained in step S2, stir for 5-10 min, add deionized water to make the final volume 100%, let stand and mature for 12-24 h to obtain the peracetic acid disinfectant solution. The stabilizer includes hydroxypropyl-β-cyclodextrin and 1,2-propanediol; The method for preparing the stabilizer includes the following steps: Add deionized water to the reaction vessel, making up 60% of the final volume, and add hydroxypropyl-β-cyclodextrin and 1,2-propanediol. Stir the reaction for 10-20 minutes, then add citric acid to adjust the pH of the system to 5.6-6.0 to obtain the stabilizer.

2. The peracetic acid-based disinfectant solution for endoscope disinfection according to claim 1, characterized in that, The mass ratio of hydroxypropyl-β-cyclodextrin to 1,2-propanediol is 1:(4-8).

3. The peracetic acid-based disinfectant solution for endoscope disinfection according to claim 1, characterized in that, In step S2, the addition time is controlled to be 30-45 minutes.

4. The application of a peracetic acid-based disinfectant solution for endoscope disinfection according to any one of claims 1-3 in endoscope disinfection.

5. The application of a peracetic acid-based disinfectant solution for endoscope disinfection according to any one of claims 1-3 in the disinfection of medical devices.

6. The application of a peracetic acid disinfectant solution for endoscope disinfection according to any one of claims 1-3 in the disinfection of metal products.

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