Disinfectant for washing endoscope lens in operation process and preparation method thereof

Abstract

The invention discloses a disinfectant for washing an endoscope lens in the operation process and a preparation method of the disinfectant, and belongs to the field of disinfectant preparation, the disinfectant is prepared from the following raw materials in parts by weight: 1.0-2.0 parts of quaternary ammonium salt, 0.05-0.5 part of antibacterial peptide, 50.0-100.0 parts of an active matter auxiliary agent, 1.0-10.0 parts of a dispersing agent, 0.1-5.0 parts of a humectant and 9 parts of an osmotic pressure regulator, the flushing disinfectant has the beneficial effects that the flushing disinfectant is obtained by compounding the active substance auxiliary agent, the low-concentration quaternary ammonium salt and the antibacterial peptide, is used for flushing an endoscope lens, can achieve the effects of preventing fog, quickly removing dirt and ensuring the cleanness of the lens and the clear view field, also has a disinfection and sterilization effect, and is suitable for popularization and application. And infection easily caused in the puncture process due to repeated flushing of iodine-containing disinfectant is avoided.

Description

Technical field:

[0001] The invention relates to the field of disinfectant preparation, and in particular to a disinfectant for flushing a laparoscope lens during a surgical procedure and a preparation method thereof. Background technology:

[0002] With the rapid development of modern medicine, laparoscopic surgery is increasingly used in clinical practice. Eyepiece surgical instruments are the golden key to minimally invasive surgery and the doctor's second pair of eyes. The surgical field of view conveyed by the laparoscope lens will also become the basis for the doctor to perform the operation. However, during the operation, due to the temperature difference between the inside and outside of the body cavity and the smoke generated during the use of electrocoagulation and electroresection surgical instruments, water mist is easily formed on the lens surface when the lens enters the body cavity or when the electrosurgical equipment is working, affecting the surgical field of view and screen clarity. In addition, when the lens contacts human tissue and blood, these will also adhere to the lens surface as contaminants, thereby affecting the clarity of the lens.

[0003] At present, the more commonly used solutions in clinical practice are: first, wipe with iodine tincture, but it needs to be cleaned repeatedly, which is easy to cause secondary contamination during the puncture process; second, use the lens anti-fog bubble washing thermos cup, but its effect also has certain limitations; third, mix iodine tincture with physiological saline to rinse the lens; For example, the invention patent 202410472726.9 "An iodine-containing cleaning and disinfecting solution for flushing laparoscopic lenses during surgery and its preparation method" jointly applied by our company and West China Hospital uses sodium carboxymethyl cellulose as a dispersant. Sodium carboxymethyl cellulose can work synergistically with the iodine chelating agent polyvinyl pyrrolidone to achieve an anti-fog effect, which has a relatively positive effect on lens anti-fog; carboxymethyl chitosan has a enhancing effect on the iodine chelating effect of the iodine chelating agent. This method generally requires heating for use, and requires multiple flushing to achieve the corresponding effect. Summary of the invention:

[0004] Based on the existing problems described in the background technology, the present invention proposes a disinfectant for flushing the laparoscope lens during surgery and a preparation method thereof. The disinfectant prepared by the present invention can be used at room temperature, and can achieve the effects of anti-fogging, decontamination and maintaining a clear field of vision after one flush. In addition, the quaternary ammonium salt bactericidal component contained has a sustained antibacterial effect, which can avoid secondary infection caused by repeated puncture after cleaning.

[0005] The specific technical solution of the present invention to solve the above technical problems is: The invention discloses a disinfectant for flushing a laparoscope lens during a surgical procedure, wherein the disinfectant comprises the following raw materials in a weight ratio: 1.0-2.0 parts of a quaternary ammonium salt, 0.05-0.5 parts of an antimicrobial peptide, 50.0-100.0 parts of an active ingredient auxiliary agent, 1.0-10.0 parts of a dispersant, 0.1-5.0 parts of a humectant, and 9 parts of an osmotic pressure regulator.

[0006] The quaternary ammonium salt bactericidal component is a single-chain quaternary ammonium salt, a double-chain quaternary ammonium salt or a composite quaternary ammonium salt.

[0007] The antimicrobial peptides are cationic antimicrobial peptides, including LL-37, rubber protein, GH12, and SAAP-148.

[0008] The active ingredient auxiliary agent is one or more of fatty alcohol polyoxyethylene ether, alkyl polyglycoside, Tween-80, polyoxyethyl nonylphenyl ether and alkyl aromatic polyoxyethylene ether with good detergency and wettability.

[0009] The moisturizing agent is one or more of glycerin, butylene glycol, propylene glycol and D-panthenol.

[0010] The osmotic pressure regulator is sodium chloride.

[0011] The dispersant is polyethylene glycol 400, which mainly plays a synergistic effect of removing silicone oil.

[0012] A method for preparing a disinfectant for flushing a laparoscope lens during a surgical procedure comprises the following steps: S1. Add the osmotic pressure regulator into sterile purified water, stir and dissolve for 10-20 minutes to obtain an isotonic sodium chloride solution; add the antimicrobial peptide into the above solution at room temperature and pressure, stir well for 2.5-4 hours to complete the activation reaction, and obtain an activated solution; S2. Add active ingredient additive, dispersant and moisturizer to the activation solution, stir and dissolve for 1 to 1.5 hours, then add quaternary ammonium salt, stir for 30 minutes, and prepare a flushing disinfectant containing quaternary ammonium salt.

[0013] The beneficial effects of the present invention are: The present invention utilizes the compound of active ingredient auxiliary agent, low concentration quaternary ammonium salt and antimicrobial peptide to obtain a flushing disinfectant for flushing laparoscope lens, which can not only prevent fogging, quickly remove dirt and ensure lens cleanliness and clear field of vision, but also has a disinfection and sterilization effect, avoiding infection easily caused by repeated flushing with iodine-containing disinfectant during the puncture process.

[0014] The disinfectant prepared by the present invention can be used at room temperature, and can achieve the effects of anti-fogging, decontamination and maintaining clear vision by one flushing. In addition, the quaternary ammonium salt bactericidal component contained has a continuous antibacterial effect, and can avoid secondary infection caused by repeated puncture after cleaning. Description of the drawings:

[0015] Attached Figure 1 It is a sterilization plate diagram of an embodiment of the present invention; Attached Figure 2 This is an anti-fog effect diagram of an embodiment of the present invention; Attached Figure 3 It is a sterilization plate diagram of Comparative Example 1 of the present invention; Attached Figure 4 This is an anti-fog effect diagram of Comparative Example 1 of the present invention; Attached Figure 5 It is the sterilization plate diagram of Comparative Example 2 of the present invention; Attached Figure 6 It is the anti-fog effect diagram of comparative example 2 of the present invention; Attached Figure 7 It is the sterilization plate diagram of Comparative Example 3 of the present invention; Attached Figure 8 It is the anti-fog effect diagram of comparative example 3 of the present invention; Attached Fig. 9 It is a sterilization plate diagram of Comparative Example 4 of the present invention; Attached Fig.10 It is the anti-fog effect diagram of comparative example 4 of the present invention; Attached Fig.11 It is a sterilization plate diagram of Comparative Example 5 of the present invention; Attached Fig.12 It is the anti-fog effect diagram of comparative example 5 of the present invention; Specific implementation method:

[0016] In the description of the present invention, specific details are only for a full understanding of the embodiments of the present invention, but those skilled in the art should know that the implementation of the present invention is not limited to these details. In addition, well-known structures and functions are not described or shown in detail to avoid blurring the key points of the embodiments of the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0017] Specific implementation of the present invention: In order to better understand the present invention, a specific embodiment is used for illustration. It is worth emphasizing that the effect of this embodiment is not substantially different from the various embodiments within the protection scope of the present invention, including the respective reagents and the content ratio of the reagents, and all of them can achieve the effects described in the present invention and solve the above-mentioned problems. Other combinations are not described here. The invention discloses a disinfectant for flushing a laparoscope lens during a surgical procedure, wherein the disinfectant comprises the following raw materials in a weight ratio: 1.0-2.0 parts of a quaternary ammonium salt, 0.05-0.5 parts of an antimicrobial peptide, 50.0-100.0 parts of an active ingredient auxiliary agent, 1.0-10.0 parts of a dispersant, 0.1-5.0 parts of a humectant, and 9 parts of an osmotic pressure regulator.

[0018] Embodiment 1: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Benzalkonium chloride: 1.0g LL-37: 0.5g Fatty alcohol polyoxyethylene ether: 50.0g Macrogol 400: 1.0g Glycerol: 0.1g Sodium chloride: 9.0g Purified water: add to 1000g Embodiment 2: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Tetradecyl dimethyl benzyl ammonium chloride: 1.2g LL-37: 0.4g Dodecyl dimethyl sulfonyl betaine: 60.0g Macrogol 400: 2.0g Butanediol: 1.2g Sodium chloride: 9.0g Purified water: add to 1000g Embodiment 3: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Benzalkonium bromide: 1.3g GH12: 0.2g Alkylphenol polyoxyethylene ether: 50.0g Macrogol 400: 5.0g Glycerin: 2.5g Sodium chloride: 9.0g Purified water: add to 1000g Embodiment 4: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Dodecyl dimethyl phenoxyethyl ammonium bromide: 1.5g LL-37: 0.2g Decyl Hydroxypropyl Sulfobetaine: 80.0g Macrogol 400: 2.0g Propylene glycol: 3.0g Sodium chloride: 9.0g Purified water: add to 1000g Embodiment 5: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Didecyldimethylammonium chloride: 1.6g SAAP-148: 0.1g Alkyl glycoside: 50.0g Macrogol 400: 8.0g Propylene glycol: 4.0g Sodium chloride: 9.0g Purified water: add to 1000g Embodiment 6: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Octyldecyl dimethyl ammonium chloride: 1.8g LL-37: 0.1g Dodecylethoxysulfobetaine: 100.0g Macrogol 400: 5.0g Glycerin: 2.0g Sodium chloride: 9.0g Purified water: add to 1000g Embodiment 7: The weight ratio of raw materials of quaternary ammonium salt flushing disinfectant is: Didecyldimethylammonium bromide: 2.0g LL-37: 0.05g Tween-80: 100.0g Macrogol 400: 10.0g Butanediol: 5.0g Sodium chloride: 9.0g Purified water: add to 1000g; According to the following preparation method according to Examples 1-7, S1. Add the osmotic pressure regulator into sterile purified water, stir and dissolve for 10-20 minutes to obtain an isotonic sodium chloride solution; add the antimicrobial peptide into the above solution at room temperature and pressure, stir well for 2.5-4 hours to complete the activation reaction, and obtain an activated solution; S2. Add active ingredient additive, dispersant and moisturizer to the activation solution, stir and dissolve for 1 to 1.5 hours, then add quaternary ammonium salt, stir for 30 minutes, and prepare a flushing disinfectant containing quaternary ammonium salt.

[0019] In order to more intuitively demonstrate the process advantages of the present invention, the disinfectant used for washing the laparoscope lens during surgery and its preparation method are compared with the method of equivalent replacement using the same process. Comparative Example 1: By way of reference, the Company's Lierkang ® Composite double-chain quaternary ammonium salt disinfectant, containing low-concentration composite quaternary ammonium salt and low-concentration active ingredient adjuvant; the concentration meets the recommended dosage of "General Requirements for Skin Disinfectants" in GB 27951-2021; The difference between this product and the present invention is that no antimicrobial peptide is added and it contains low-concentration composite quaternary ammonium salt and low-concentration active ingredient adjuvant; this product is a low-concentration diluent and can be used for cleaning and disinfecting the surface of ordinary objects, but cannot be used for flushing and disinfecting laparoscope lenses during surgery; Comparative Example 2: Comparative Example 2 is the concentrated solution of Comparative Example 1; that is, Comparative Example 1 is obtained by diluting Comparative Example 2 10 times, and the difference from the present invention is that no antimicrobial peptide is added and the concentration of the bactericidal component quaternary ammonium salt is high; Comparative Example 3: The difference between the preparation method and the embodiment is that: in the preparation process of this comparative example, no bactericidal component quaternary ammonium salt is added; Comparative Example 4: The preparation method is the same as that of the example, except that: in the preparation process of this comparative example, no antimicrobial peptide is added; Comparative Example 5: The preparation method is the same as that of the embodiment, except that: in the preparation process of this comparative example, no active ingredient auxiliary agent is added; The above examples and comparative examples were tested according to the following method: Killing test results of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans: 1. Staphylococcus aureus killing test The quaternary ammonium salt flushing disinfectant stock solution of the present invention uses D / E neutralizing broth as a neutralizer and acts on Staphylococcus aureus for 2 minutes, thereby effectively neutralizing the disinfectant remaining in the suspension, and the neutralizer and the neutralization product have no adverse effects on the test bacteria and the culture medium.

[0020] The quaternary ammonium salt flushing disinfectant stock solution (benzalkonium chloride content: 1000 mg / L) acts on Staphylococcus aureus for 2 minutes, and the killing logarithm value is greater than 5.00.

[0021] 2. E. coli killing test The quaternary ammonium salt flushing disinfectant stock solution (benzalkonium chloride content: 1000 mg / L) acts on Escherichia coli for 2 minutes, and the killing logarithm value is greater than 5.00.

[0022] 3. Pseudomonas aeruginosa killing test The quaternary ammonium salt flushing disinfectant stock solution (benzalkonium chloride content: 1000 mg / L) acts on Pseudomonas aeruginosa for 2 minutes, and the killing logarithm value is greater than 5.00.

[0023] Candida albicans killing test The quaternary ammonium salt flushing disinfectant stock solution of the present invention uses D / E neutralizing broth as a neutralizer and acts on Candida albicans for 2 minutes, thereby effectively neutralizing the disinfectant remaining in the suspension, and the neutralizer and the neutralization product have no adverse effects on the test bacteria and the culture medium.

[0024] The quaternary ammonium salt flushing disinfectant stock solution (benzalkonium chloride content: 1000 mg / L) acts on Candida albicans for 2 minutes, and the killing logarithm value is greater than 4.00.

[0025] Table 1: Comparative experimental data of sterilization effects of different embodiments

[0026] From the data analysis in Table 1, we can see that: (1) It can be seen from Examples 1-7 that: In terms of disinfection and sterilization effects, the various embodiments have little difference in killing Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans, all of which have excellent disinfection and sterilization effects, and meet the requirements of GB 27951-2021 "General Requirements for Skin Disinfectants" and GB 27949-2020 "General Requirements for Medical Device Disinfectants"; they can avoid infection that is easily caused by repeated flushing during the puncture process.

[0027] Table 2: Comparative experimental data of sterilization effect and anti-fogging effect of different embodiments and comparative examples

[0028] From the data analysis in Table 2, we can see that: (1) Comparison between Example 1 and Comparative Example 1 shows that: Comparative Example 1 is Lierkang sold by our company ® Composite double-chain quaternary ammonium salt disinfectant contains low-concentration composite quaternary ammonium salt and low-concentration active ingredient adjuvant; the concentration meets the recommended dosage of GB 27951-2021 "General Requirements for Skin Disinfectants"; it has excellent bactericidal effect and meets the requirements for bactericidal effect of GB 27951-2021 "General Requirements for Skin Disinfectants"; The difference between this product and the present invention is that no antimicrobial peptides are added and it contains low concentrations of active ingredient adjuvants; this product is a low concentration diluent, which is used for surface disinfection of ordinary objects and cannot be used for washing laparoscope lenses during surgery. The anti-fogging effect is extremely poor. For details, see Figure 4 ; (2) By comparing the embodiment and comparative example 4, it can be seen that: The inventive concept of the present invention is based on the company's product, namely, Lierkang ® Compound double-chain quaternary ammonium salt disinfectant. Since this product cannot be used to flush the laparoscope lens during surgery, the anti-fog effect is extremely poor. Figure 4 ; In order to obtain the anti-fog effect, the inventor increased the content of the active ingredient auxiliary agent that can promote the anti-fog effect. As expected, the anti-fog effect of the disinfectant prepared in this way can meet the needs of rinsing the laparoscope lens during the surgical process. It can be used at room temperature, and one rinse can achieve the effects of anti-fog, decontamination and maintaining a clear field of vision; However, when verifying the bactericidal effect, it was unexpectedly found that the bactericidal effect of the comparative example could not meet the requirements of GB 27951-2021 "General Requirements for Skin Disinfectants" for bactericidal effect; From this we can infer: Although the concentration and type of the quaternary ammonium salt added in the comparative example are the same as those of the present invention, it does not produce the same bactericidal effect as the present invention. It is preliminarily judged that the active ingredient auxiliary agent that can promote the anti-fog effect has a reverse inhibitory effect on the bactericidal effect of the low-concentration quaternary ammonium salt; (3) By comparing the embodiment with comparative examples 2 and 4, it can be seen that: Based on the problems of Example 4 and Comparative Example 4, the inventors further studied the influence of the concentration of quaternary ammonium salt and the interaction of active ingredient adjuvant on the bactericidal effect; The difference between Comparative Example 2 and Comparative Example 4 is that the concentration of quaternary ammonium salt is increased in order to obtain a disinfectant having an anti-fogging effect and a bactericidal effect at the same time, but the bactericidal effect of this comparative example cannot meet the requirements for bactericidal effect of GB 27951-2021 "General Requirements for Skin Disinfectants"; From this we can infer: Active additives that can promote the anti-fog effect have a reverse inhibitory effect on the bactericidal effect of low-concentration and high-concentration quaternary ammonium salts. The present invention unexpectedly and creatively adds antimicrobial peptides to eliminate the reverse inhibition of the active ingredient adjuvant on the bactericidal effect of low-concentration and high-concentration quaternary ammonium salts; (4) By comparing the embodiment and comparative example 3, it can be seen that: Comparative Example 3 is to verify the release principle of the antimicrobial peptide, and the difference from the present invention is that no high concentration of quaternary ammonium salt is added; that is, the interaction between the antimicrobial peptide and the active ingredient adjuvant is studied; Since antimicrobial peptides only have antimicrobial effects but no bactericidal effects, and active ingredient additives do not have bactericidal effects, theoretically, adding antimicrobial peptides will not promote the bactericidal effect. After verification, the antimicrobial peptide and active ingredient auxiliary agent were added to Comparative Example 3, but there was still no bactericidal effect, which was consistent with the theoretical inference. As for the anti-fog effect, there was no significant difference with the present invention. It can be seen that there was no unexpected effect between the antimicrobial peptide and the active ingredient auxiliary agent in the anti-fog effect and the antibacterial effect. (5) By comparing the embodiment and comparative example 5, it can be seen that: The inventors further studied the effects of antimicrobial peptides and quaternary ammonium salts on the bactericidal effect, namely, comparative example 5, which differs from the present invention in that no active ingredient adjuvant is added; The experimental results show that the absence of active ingredient additives causes the disinfectant to lose its anti-fogging effect, but the effect on the bactericidal effect is not significantly different from that of the present invention. Therefore, the antimicrobial peptide and the quaternary ammonium salt have neither a promoting effect nor an inhibiting effect on the bactericidal effect. In summary: Based on the experimental comparison of the above embodiments and comparative examples, it can be seen that the addition of active ingredient adjuvants, quaternary ammonium salts and antimicrobial peptides jointly affect the bactericidal effect, especially the antimicrobial peptides relieve the reverse inhibition of the active ingredient adjuvants on the bactericidal effect of low-concentration and high-concentration quaternary ammonium salts; The present invention utilizes a compound of active ingredient auxiliary agents, low-concentration quaternary ammonium salts and antimicrobial peptides to obtain a flushing disinfectant for flushing a laparoscope lens, which can not only prevent fogging, quickly remove dirt, and ensure lens cleanliness and clear vision, but also has a disinfection and sterilization effect, avoiding infection that is easily caused by repeated flushing with iodine-containing disinfectants during the puncture process.

[0029] The disinfectant prepared by the present invention can be used at room temperature, and can achieve the effects of anti-fogging, decontamination and maintaining clear vision by one flushing. In addition, the quaternary ammonium salt bactericidal component contained has a continuous antibacterial effect, and can avoid secondary infection caused by repeated puncture after cleaning.

Claims

1. A disinfectant for flushing the laparoscope lens during surgery, characterized in that The raw materials weight ratio of the disinfectant is: 1.0-2.0 parts of quaternary ammonium salt, 0.05-0.5 parts of antimicrobial peptide, 50.0-100.0 parts of active ingredient auxiliary agent, 1.0-10.0 parts of dispersant, 0.1-5.0 parts of moisturizer and 9 parts of osmotic pressure regulator.

2. The disinfectant for flushing the laparoscope lens during surgery according to claim 1, characterized in that The quaternary ammonium salt bactericidal component is a single-chain quaternary ammonium salt, a double-chain quaternary ammonium salt or a composite quaternary ammonium salt.

3. The disinfectant for flushing the laparoscope lens during surgery according to claim 1, characterized in that The antimicrobial peptides are cationic antimicrobial peptides, including LL-37, rubber protein, GH12, and SAAP-148.

4. The disinfectant for flushing the laparoscope lens during surgery according to claim 1, characterized in that The active ingredient auxiliary agent is one or more of fatty alcohol polyoxyethylene ether, alkyl glucosides, Tween-80, polyoxyethyl nonylphenyl ether and alkyl aromatic polyoxyethylene ether.

5. The disinfectant for flushing the laparoscope lens during surgery according to claim 1, characterized in that The moisturizing agent is one or more of glycerin, butylene glycol, propylene glycol and D-panthenol.

6. The disinfectant for flushing the laparoscope lens during surgery according to claim 1, characterized in that The osmotic pressure regulator is sodium chloride.

7. The disinfectant for flushing the laparoscope lens during surgery according to claim 1, characterized in that The dispersant is polyethylene glycol 400.

8. A method for preparing a disinfectant for flushing a laparoscope lens during surgery, using the disinfectant formulation of any one of claims 1 to 7, characterized in that The preparation method comprises the following steps: S1. Add an osmotic pressure regulator into sterile purified water, stir and dissolve for 10-20 minutes to obtain an isotonic sodium chloride solution; add an antimicrobial peptide into the above solution at room temperature and pressure, stir well for 2.5-4 hours to complete the activation reaction, and obtain an activated solution; S2. Add active ingredient additive, dispersant and moisturizer to the activation solution, stir and dissolve for 1-1.5 hours, then add quaternary ammonium salt, stir for 30 minutes, and prepare a flushing disinfectant containing quaternary ammonium salt.

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