Water-soluble lubricating composition and use in a lubricating cloth

Abstract

The application discloses a water-soluble lubricating composition and application in a lubricating cloth, and belongs to the technical field of medical lubricating materials. The composition takes a basic lubricating component with a specific ratio as a matrix, and is matched with a compounded water-soluble antibacterial component composed of polyhexamethylene guanidine hydrochloride, epsilon-polylysine hydrochloride and self-made quaternary ammonium hyaluronic acid sodium, and a preparation method of the composition and corresponding antibacterial lubricating cloth is disclosed. The application solves the core pain points of poor lubricating persistence, narrow antibacterial spectrum, easy drug resistance, insufficient storage stability, weak combination with non-woven fabric and great mucous membrane irritation of the existing urinary catheter lubricating products through system synergistic optimization, and the product has excellent lubricating drag reduction, broad-spectrum antibacterial performance, good storage stability and biocompatibility, can effectively reduce the urethral injury and infection risk of urinary catheter operation, and is suitable for clinical medical scenes.

Description

Technical Field

[0001] This invention belongs to the field of medical lubricating materials technology, specifically relating to a water-soluble antibacterial lubricating composition and its application in lubricating cloth. Background Technology

[0002] Urinary catheterization is one of the most commonly used invasive procedures in clinical practice, widely applied in scenarios such as urinary drainage, bladder function monitoring, and intracavitary drug administration for patients with urinary dysfunction, perioperative patients, and critically ill patients. However, urinary catheterization itself has two major clinical pain points: First, the physical friction between the catheter and the urethral mucosa can cause damage to urethral epithelial cells, leading to severe pain and urethral spasm in patients. In severe cases, it can cause urethral tears, bleeding, edema, and even long-term complications such as urethral stricture. Second, urinary catheterization is a leading cause of hospital-acquired infections, which not only prolongs hospital stays and increases the medical burden, but can also lead to bacteremia and sepsis in severe cases, endangering the patient's life.

[0003] Currently, commonly used catheter lubricants in clinical practice are mainly divided into two categories: one is water-soluble lubricant, with glycerin, propylene glycol, carbomer, etc. as core lubricating components. It can only achieve basic lubrication and drag reduction effects, without clear antibacterial function, and cannot reduce the risk of infection. It also has problems such as poor lubrication retention and easy loss during the advancement of the catheter, resulting in fluctuations in frictional resistance during insertion, poor operation, and aggravation of mucosal damage. The other category is pre-impregnated lubricating cloth, which uses non-woven fabric to absorb lubricant for convenient drug administration. However, existing products generally have the problem of poor bonding between the lubricating composition and the non-woven fabric. After impregnation, it is easy for the liquid to drip and the liquid retention rate is low. During use, the lubricating components are quickly detached due to friction, and it is impossible to achieve uniform and long-lasting lubrication and protection.

[0004] To address the need for antibacterial properties, some existing lubricating products contain added antibacterial ingredients, but many unresolved technical defects remain: First, the antibacterial system design is unreasonable, often using a single antibacterial agent, which has problems such as a narrow antibacterial spectrum, easy induction of bacterial resistance, and low bactericidal efficiency. In particular, it is ineffective against common clinical fungal pathogens and cannot effectively cover the main pathogens of CAUTI. Some products use a simple combination of multiple antibacterial agents, but fail to achieve synergistic effects. They can only improve the bactericidal effect by increasing the amount of antibacterial agent, which greatly increases the risk of urethral mucosal irritation.

[0005] Secondly, the antibacterial components have poor compatibility with water-soluble lubricating systems, and are prone to problems such as system stratification, precipitation, discoloration, and significant decrease in viscosity during storage. Performance deteriorates severely under hot storage, light exposure, and low temperature conditions, resulting in a significant decrease in lubrication and antibacterial properties within the product's shelf life, which fails to meet the stability requirements of medical products.

[0006] Third, the problem of bonding between the antibacterial lubricating composition and the medical nonwoven fabric has not been solved. The addition of antibacterial components further damages the bonding force between the system and the cellulose molecules of the nonwoven fabric, resulting in a further decrease in liquid retention. The lubricant is prone to dripping and leakage, and cannot achieve dual long-term protection of "lubrication + antibacterial".

[0007] Fourth, poor biocompatibility. Some antibacterial agents are highly irritating to the urethral mucosa, easily causing mucosal congestion, edema, and inflammatory reactions, which in turn damages the physiological barrier of the urethral mucosa and increases the risk of infection. They are not suitable for patients with long-term indwelling catheters or patients with existing urethral mucosal damage.

[0008] Therefore, developing a water-soluble lubricating composition that combines excellent lubrication and drag reduction properties, broad-spectrum and efficient synergistic antibacterial properties, excellent storage and light stability, strong bonding ability with medical nonwoven fabrics, and good biocompatibility, and its large-scale application in lubricating fabrics, is of great clinical significance and market application value for solving the core pain points of clinical catheterization, reducing the risk of urethral injury and infection, and improving the safety of clinical operations and patient comfort. Summary of the Invention

[0009] In view of the above-mentioned defects in the existing technology, the purpose of this invention is to provide a water-soluble antibacterial lubricating composition and its application in lubricating cloth. This composition solves the four core problems of existing catheter lubricating products, namely insufficient lubrication performance, poor antibacterial effect, poor storage stability, and weak bonding ability with non-woven fabrics, through the innovative design of synergistic optimization of the basic lubrication system and specific ratio compounding of water-soluble antibacterial system. It has outstanding substantive features and significant progress.

[0010] The objective of this invention can be achieved through the following technical solutions: A water-soluble antibacterial lubricating composition, by weight, comprises 100 parts of a basic lubricating component and 0.17-1.3 parts of a compounded water-soluble antibacterial component; The basic lubricating components, by weight, include: 10-30 parts glycerin, 0.1-0.5 parts carbomer, 0.05-0.3 parts xanthan gum, 5-15 parts polyethylene glycol 400, 0.1-0.6 parts triethanolamine, 0.05-0.2 parts methylparaben, 0.02-0.1 parts propylparaben, and 50-80 parts purified water; The compounded water-soluble antibacterial components, by weight, include: 0.05-0.3 parts of polyhexamethylene guanidine hydrochloride, 0.02-0.2 parts of ε-polylysine hydrochloride, and 0.1-0.8 parts of quaternized sodium hyaluronate; The preparation method of the quaternized sodium hyaluronate is as follows: S01 Raw material preparation: Take medical-grade sodium hyaluronate (molecular weight 80000-120000Da), 2,3-epoxypropyltrimethylammonium chloride (quaternization reagent), isopropanol, sodium hydroxide, hydrochloric acid, and purified water. All raw materials meet medical-grade standards and have no impurities. SO2 pretreatment: Add sodium hyaluronate to purified water, control the temperature at 30-40℃, stir at 150-200 r / min for 30-40 min until completely dissolved, to obtain a sodium hyaluronate aqueous solution with a mass concentration of 2-5%. Then add sodium hydroxide to adjust the pH of the system to 9.0-10.0, and keep warm for 10-15 min for activation treatment. SO3 Quaternization reaction: Isopropanol is added to the activated sodium hyaluronate aqueous solution, with a volume ratio of isopropanol to sodium hyaluronate aqueous solution of 1:1-1:2. After stirring evenly, 2,3-epoxypropyltrimethylammonium chloride is slowly added dropwise, with a mass ratio of 2,3-epoxypropyltrimethylammonium chloride to sodium hyaluronate of 0.3:1-0.6:1. After the addition is complete, the temperature is raised to 50-60℃, and the reaction is maintained at this temperature with stirring for 2-4 hours. The stirring speed is maintained at 180-220 r / min. During this period, samples are taken every 30 minutes to detect the degree of substitution of the system until the degree of substitution reaches 0.2-0.5, at which point the reaction is stopped. SO4 purification treatment: After the reaction is completed, adjust the pH of the system to 6.0-7.0 with hydrochloric acid, then pour the reaction solution into acetone, stir evenly, let stand for 15-20 min, precipitate, filter and collect the precipitate; wash the precipitate with isopropanol 2-3 times, centrifuge after each wash (3000-4000 r / min, time 5-10 min) to remove residual quaternizing reagents and impurities; S05 Drying and Pulverizing: Place the washed precipitate in a vacuum drying oven, control the drying temperature at 45-55℃ and the vacuum degree at -0.08~-0.06MPa, dry for 8-12 hours until the moisture content is ≤0.5%, then pulverize to 80-100 mesh, and after sieving, obtain a white powdery quaternized sodium hyaluronate product, which is sealed and stored for later use.

[0011] Further, the basic lubricating components, by weight, preferably include: 15-25 parts glycerin, 0.2-0.4 parts carbomer, 0.1-0.2 parts xanthan gum, 8-12 parts polyethylene glycol 400, 0.2-0.5 parts triethanolamine, 0.08-0.15 parts methylparaben, 0.03-0.08 parts propylparaben, and 60-75 parts purified water.

[0012] Further, the compounded water-soluble antibacterial components preferably include, by weight, 0.1-0.2 parts of polyhexamethylene guanidine hydrochloride, 0.05-0.15 parts of ε-polylysine hydrochloride, and 0.3-0.6 parts of quaternized sodium hyaluronate.

[0013] Furthermore, the mass ratio of polyhexamethylene guanidine hydrochloride to ε-polylysine hydrochloride is (1-3):1; the mass of the quaternized sodium hyaluronate is 2-5 times the total mass of polyhexamethylene guanidine hydrochloride and ε-polylysine hydrochloride.

[0014] Furthermore, the composition has a pH value of 5.5-7.0 and a dynamic viscosity of 8000-20000 mPa·s at 25°C, which is perfectly matched to the physiological environment of the human urethral mucosa, and has both excellent fluidity and adhesion.

[0015] The present invention also provides a method for preparing the above-mentioned water-soluble antibacterial lubricating composition, comprising the following steps: S1 Weigh the purified water according to the formula and add it to the sterile mixing tank. Heat it to 40-50℃, turn on the stirrer, and control the speed at 250-350r / min. Slowly add carbomer and xanthan gum, stir for 25-35min until completely dispersed, without clumping or dry powder particles, and continue to keep warm and swell for 1.5-2.5h to obtain a uniform and transparent aqueous matrix. S2: Keep the temperature of the mixing tank at 40-50℃ and the stirring speed at 250-350r / min. Add glycerol, polyethylene glycol 400, methylparaben, and propylparaben sequentially to the aqueous matrix of S1. Continue to keep the temperature and stir for 15-25min until all materials are completely dissolved, the system is uniform and transparent, and the mixture A is obtained. S3. While maintaining a stirring speed of 250-350 r / min, slowly add triethanolamine dropwise to mixture A from S2. After the addition is complete, continue stirring for 10-20 min to neutralize the system until the pH value is 5.5-7.0. The carbomer will completely swell to form a uniform and transparent gel system, thus obtaining the basic lubricating gel. S4. Cool the mixing tank to room temperature (25±2℃), adjust the stirring speed to 180-220 r / min, add polyhexamethylene guanidine hydrochloride, ε-polylysine hydrochloride, and quaternized sodium hyaluronate to the basic lubricating gel in S3, stir for 25-35 min until completely dissolved, then turn on the homogenizer, control the homogenization speed to 1200-1800 r / min, homogenize for 8-12 min, and vacuum degas for 15-25 min to obtain the water-soluble antibacterial lubricating composition.

[0016] This invention also provides the application of the above-mentioned water-soluble antibacterial lubricating composition in medical lubricating cloth, and the antibacterial lubricating cloth prepared from the composition, the antibacterial lubricating cloth comprising a medical nonwoven fabric carrier and the above-mentioned water-soluble antibacterial lubricating composition loaded on the medical nonwoven fabric carrier; the preparation method is as follows: the medical nonwoven fabric is completely immersed in the above-mentioned water-soluble antibacterial lubricating composition for 10-30 seconds, after being taken out, it is vertically suspended to drain excess free liquid, aseptically sealed and packaged, and sterilized with ethylene oxide to obtain the finished antibacterial lubricating cloth.

[0017] In the basic lubricating components of this invention, glycerin and polyethylene glycol 400 serve as polyol moisturizing lubricants, exhibiting excellent water solubility and film-forming properties. They can form a continuous hydrated lubricating film on the surface of the catheter and the urethral mucosa, significantly reducing the interfacial friction coefficient. Carbomer and xanthan gum serve as composite thickening rheology modifiers, exhibiting a significant synergistic thickening effect. Carbomer provides the system's base viscosity and gel structure, while xanthan gum imparts excellent shear resistance and thixotropy. During the dynamic shearing process of catheter insertion, the lubricating film remains intact and unbroken, preventing lubricant loss and achieving long-lasting lubrication. Triethanolamine serves as a neutralizing agent, precisely controlling the system's pH value to the suitable weakly acidic to neutral range for the human urethral mucosa, while simultaneously optimizing the swelling effect of carbomer and balancing the system's viscosity and flowability. Methylparaben and propylparaben serve as composite preservatives, broadly inhibiting the growth of bacteria and fungi in the system through the synergistic effect of parabens, ensuring the product's microbial safety during storage.

[0018] This invention employs three water-soluble antibacterial agents—polyhexamethylene guanidine hydrochloride, ε-polylysine hydrochloride, and quaternized sodium hyaluronate—in a specific ratio to achieve synergistic effects, which is the core inventive aspect of this invention. Polyhexamethylene guanidine hydrochloride is a cationic polymeric antibacterial agent. It adsorbs onto the negatively charged bacterial cell membrane surface through positively charged groups, destroying the phospholipid bilayer structure of the cell membrane, causing the bacterial contents to leak out and die. At the same time, it can coagulate bacterial proteins and inhibit the activity of bacterial enzyme systems. It has a rapid and efficient killing effect on both Gram-positive and Gram-negative bacteria and is not prone to drug resistance. ε-Polylysine hydrochloride is a bio-derived cationic antimicrobial peptide that adsorbs onto the bacterial cell wall, disrupting the peptidoglycan structure of the cell wall. Simultaneously, it penetrates the cell membrane to enter the cell, inhibiting the synthesis of bacterial DNA and proteins, thereby achieving a bactericidal effect. Its bactericidal mechanism is completely different from that of polyhexamethylene guanidine hydrochloride. When the two are combined, their antimicrobial spectra are completely complementary, enabling them to act on pathogenic bacteria from multiple targets simultaneously, significantly improving bactericidal efficiency, while significantly reducing the dosage of single antimicrobial agents and reducing mucosal irritation. Quaternized sodium hyaluronate is the key innovative component of this invention. It is a modified product in which quaternary ammonium cationic groups are introduced into the sodium hyaluronate molecular chain. It retains the excellent moisturizing and lubricating properties, biocompatibility and mucosal adhesion of sodium hyaluronate, while endowing it with specific antibacterial properties through cationic groups. At the same time, its cationic groups can synergistically interact with polyhexamethylene guanidine hydrochloride and ε-polylysine hydrochloride, enriching the two antibacterial agents on the surface of pathogenic bacteria through electrostatic adsorption, forming an "antibacterial enrichment zone" and greatly improving the bactericidal efficiency. More importantly, it can form a three-dimensional network structure in the system, anchoring the antibacterial agent molecules in the network, avoiding the degradation and inactivation of the antibacterial agents during storage, and significantly improving the storage stability of the antibacterial system.

[0019] This invention achieves a synergistic effect of "1+1+1>3" by combining three antibacterial agents in a specific ratio. It can kill more than 99.9% of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans, which are the most common clinical CAUTIs, after 2 minutes of contact. At the same time, it significantly reduces the total amount of antibacterial agents used and ensures the biosafety of the product.

[0020] This invention, through the molecular structure design of quaternized sodium hyaluronate, perfectly solves the problem of poor adhesion between the antibacterial lubricating composition and nonwoven fabric: the molecular chain of quaternized sodium hyaluronate contains a large number of hydroxyl and carboxyl groups, which can form a large number of hydrogen bonds with the cellulose molecules of medical nonwoven fabric. At the same time, its cationic groups can generate electrostatic adsorption with the negative potential point of cellulose molecules, thereby firmly anchoring the entire lubricating composition system to the surface of nonwoven fabric fibers, greatly improving the liquid retention rate after impregnation and preventing droplets from falling off. Meanwhile, its excellent film-forming and adhesive properties can form a continuous lubricating and antibacterial film on the surface of nonwoven fabric. After repeated friction during use, the lubricating components can still remain on the surface of nonwoven fabric in a high proportion, achieving long-lasting lubrication and antibacterial protection.

[0021] The composition of the present invention achieves excellent stability through precise design of system compatibility: the three-dimensional network structure formed by quaternized sodium hyaluronate can uniformly disperse the basic lubricating components and antibacterial components in the network, avoiding the formation of stratification and precipitation in the system; at the same time, its molecular structure has excellent heat resistance and photodegradation resistance, which can protect the antibacterial components in the system from being destroyed by high temperature and light, and avoid the decay of bactericidal performance.

[0022] The beneficial effects of this invention are: 1. The composition of the present invention can form a uniform, dense, and shear-resistant hydrated lubricating film on the surface of the catheter, which can significantly reduce the physical frictional resistance between the catheter and the urethral mucosa, avoid the obstruction caused by resistance fluctuations during operation, greatly reduce urethral mucosal damage, and alleviate patient pain and discomfort.

[0023] 2. The ternary compound antibacterial system of the present invention has complementary bactericidal mechanisms and synergistic effects. Its antibacterial spectrum covers all common pathogens of clinical CAUTI, which can quickly kill pathogens encountered during catheterization, while not easily developing drug resistance, thus reducing the risk of catheter-related urinary tract infections from the source.

[0024] 3. The composition of the present invention can maintain stable physicochemical and antibacterial properties under extreme temperature and light conditions, without delamination, discoloration, or performance degradation, thus solving the problem of rapid performance decline in existing antibacterial lubricating products during storage and significantly extending the product's shelf life.

[0025] 4. The composition of the present invention has a strong bonding force with medical nonwoven fabric, has a high liquid retention rate after impregnation, no dripping phenomenon, and a high residual rate of lubricating components after friction, which can achieve long-term lubrication and antibacterial protection; at the same time, the lubricating cloth preparation process is simple, only requiring immersion, removal and packaging, without complicated procedures, and is suitable for large-scale industrial production.

[0026] 5. The pH value of the composition of the present invention is completely matched with the physiological environment of the human urethral mucosa. All components are medical-grade water-soluble materials, non-sensitizing and non-mutagenic. Rabbit urethral mucosa irritation test has confirmed that it is non-irritating and will not cause adverse reactions such as urethral mucosal congestion and edema. It is suitable for all types of patients, including patients with urethral mucosal damage and patients with long-term indwelling catheters. Detailed Implementation

[0027] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with embodiments, is provided below.

[0028] Example 1

[0029] The water-soluble antibacterial lubricating composition of this embodiment has the following formulation: The basic lubricating components are 100 parts, specifically: 20 parts glycerin, 0.3 parts carbomer, 0.15 parts xanthan gum, 10 parts polyethylene glycol 400, 0.35 parts triethanolamine, 0.1 parts methylparaben, 0.05 parts propylparaben, and purified water to make up the difference. The compound contains 0.75 parts of water-soluble antibacterial components, specifically: 0.15 parts of polyhexamethylene guanidine hydrochloride, 0.1 parts of ε-polylysine hydrochloride, and 0.5 parts of quaternized sodium hyaluronate. The mass ratio of polyhexamethylene guanidine hydrochloride to ε-polylysine hydrochloride is 1.5:1, and the mass of quaternized sodium hyaluronate is twice the total mass of the two. The preparation method of the quaternized sodium hyaluronate is as follows: S01 Raw material preparation: Take medical grade sodium hyaluronate (molecular weight 100,000 Da), 2,3-epoxypropyltrimethylammonium chloride, isopropanol, sodium hydroxide, hydrochloric acid, and purified water; SO2 pretreatment: Sodium hyaluronate was added to purified water, the temperature was controlled at 35℃, the stirring speed was 180r / min, and the mixture was stirred for 35min until it was completely dissolved, resulting in a sodium hyaluronate aqueous solution with a mass concentration of 3%. Sodium hydroxide was added to adjust the pH of the system to 9.5, and the system was kept at this temperature for 12min to activate it. SO3 Quaternization reaction: Isopropanol was added to the activated sodium hyaluronate aqueous solution at a volume ratio of 1:1.5. After stirring evenly, 2,3-epoxypropyltrimethylammonium chloride was slowly added dropwise at a mass ratio of 0.45:1 to sodium hyaluronate. After the addition was complete, the temperature was raised to 55°C and the reaction was maintained at this temperature with stirring for 3 hours at a stirring speed of 200 r / min. The reaction was stopped when the degree of substitution reached 0.35. SO4 purification: Adjust the pH of the system to 6.5 with hydrochloric acid, pour the reaction solution into acetone, stir well, let stand for 18 min, precipitate, filter and collect the precipitate; wash the precipitate 3 times with isopropanol, centrifuge after each wash (3500 r / min, 8 min) to remove residual impurities. S05 Drying and Pulverizing: Place the washed precipitate in a vacuum drying oven, control the drying temperature at 50℃ and the vacuum degree at -0.07MPa, dry for 10 hours until the moisture content is ≤0.5%, then pulverize to 90 mesh, and after sieving, obtain a white powdery quaternized sodium hyaluronate product, which is sealed and stored for later use.

[0030] Preparation steps: S1 Weigh the purified water according to the formula, add it to the sterile mixing tank, heat it to 45℃, start stirring, control the speed at 300r / min, slowly add carbomer and xanthan gum, stir for 30min until completely dispersed, without clumping or dry powder particles, continue to keep warm and swell for 2h to obtain a uniform and transparent aqueous matrix. S2 maintains the temperature of the mixing tank at 45℃ and the stirring speed at 300r / min. Glycerin, polyethylene glycol 400, methylparaben, and propylparaben are added sequentially to the aqueous matrix of S1. Continue to keep warm and stir for 20min until all materials are completely dissolved, the system is uniform and transparent, and the mixture A is obtained. S3. While maintaining a stirring speed of 300 r / min, slowly add triethanolamine dropwise to mixture A from S2. After the addition is complete, continue stirring for 15 min to neutralize the system until the pH value is 6.2. Carbomer completely swells to form a uniform and transparent gel system, thus obtaining the basic lubricating gel. S4. Cool the mixing tank to room temperature (25°C), adjust the stirring speed to 200 r / min, add polyhexamethylene guanidine hydrochloride, ε-polylysine hydrochloride, and the quaternized sodium hyaluronate prepared above to the basic lubricating gel in S3, stir for 30 min until completely dissolved, then turn on the homogenizer, control the homogenization speed to 1500 r / min, homogenize for 10 min, and vacuum degas for 20 min to obtain the water-soluble antibacterial lubricating composition.

[0031] Example 2

[0032] The water-soluble antibacterial lubricating composition of this embodiment has the following formulation: The basic lubricating components are 100 parts, specifically: 15 parts glycerin, 0.2 parts carbomer, 0.1 parts xanthan gum, 8 parts polyethylene glycol 400, 0.25 parts triethanolamine, 0.08 parts methylparaben, 0.03 parts propylparaben, and purified water to make up the difference. The compound contains 0.45 parts of water-soluble antibacterial components, specifically: 0.1 parts of polyhexamethylene guanidine hydrochloride, 0.05 parts of ε-polylysine hydrochloride, and 0.3 parts of quaternized sodium hyaluronate. The mass ratio of polyhexamethylene guanidine hydrochloride to ε-polylysine hydrochloride is 2:1, and the mass of quaternized sodium hyaluronate is twice the total mass of the two. The preparation method of the quaternized sodium hyaluronate is as follows: S01 Raw material preparation: Take medical grade sodium hyaluronate (molecular weight 80000Da), 2,3-epoxypropyltrimethylammonium chloride, isopropanol, sodium hydroxide, hydrochloric acid, and purified water; SO2 pretreatment: Sodium hyaluronate is added to purified water, the temperature is controlled at 30℃, the stirring speed is 150r / min, and the stirring is carried out for 30min until it is completely dissolved, so as to obtain a sodium hyaluronate aqueous solution with a mass concentration of 2%. Sodium hydroxide is added to adjust the pH value of the system to 9.0, and the system is kept at the temperature for 10min for activation. SO3 Quaternization reaction: Isopropanol was added to the activated sodium hyaluronate aqueous solution at a volume ratio of 1:1. After stirring evenly, 2,3-epoxypropyltrimethylammonium chloride was slowly added dropwise at a mass ratio of 0.3:1 to sodium hyaluronate. After the addition was complete, the temperature was raised to 50°C and the reaction was maintained at this temperature with stirring for 2 hours at a stirring speed of 180 r / min. The reaction was stopped when the degree of substitution reached 0.2. SO4 purification: Adjust the pH of the system to 6.0 with hydrochloric acid, pour the reaction solution into acetone, stir well, let stand for 15 min, precipitate, filter and collect the precipitate; wash the precipitate twice with isopropanol, centrifuge after each wash (3000 r / min, 5 min) to remove residual impurities. S05 Drying and Pulverizing: Place the washed precipitate in a vacuum drying oven, control the drying temperature at 45℃ and the vacuum degree at -0.06MPa, dry for 8 hours until the moisture content is ≤0.5%, then pulverize to 80 mesh, and after sieving, obtain a white powdery quaternized sodium hyaluronate product, which is sealed and stored for later use.

[0033] Preparation steps: S1 Weigh the purified water according to the formula, add it to the sterile mixing tank, heat it to 40℃, start stirring, control the speed at 250r / min, slowly add carbomer and xanthan gum, stir for 25min until completely dispersed, without clumping or dry powder particles, continue to keep warm and swell for 1.5h to obtain a uniform and transparent aqueous matrix. S2 maintains the temperature of the mixing tank at 40℃ and the stirring speed at 250r / min. Glycerin, polyethylene glycol 400, methylparaben, and propylparaben are added sequentially to the aqueous matrix of S1. Continue to keep warm and stir for 15min until all materials are completely dissolved, the system is uniform and transparent, and the mixture A is obtained. S3. While maintaining a stirring speed of 250 r / min, slowly add triethanolamine dropwise to the mixture A from S2. After the addition is complete, continue stirring for 10 min to neutralize the system until the pH value is 5.8. The carbomer completely swells to form a uniform and transparent gel system, thus obtaining the basic lubricating gel. S4. Cool the mixing tank to room temperature (25°C), adjust the stirring speed to 180 r / min, add polyhexamethylene guanidine hydrochloride, ε-polylysine hydrochloride, and the above-prepared quaternized sodium hyaluronate to the basic lubricating gel in S3, stir for 25 min until completely dissolved, then turn on the homogenizer, control the homogenization speed to 1200 r / min, homogenize for 8 min, and vacuum degas for 15 min to obtain the water-soluble antibacterial lubricating composition.

[0034] Example 3

[0035] The water-soluble antibacterial lubricating composition of this embodiment has the following formulation: The basic lubricating components are 100 parts, specifically: 25 parts glycerin, 0.4 parts carbomer, 0.2 parts xanthan gum, 12 parts polyethylene glycol 400, 0.45 parts triethanolamine, 0.15 parts methylparaben, 0.08 parts propylparaben, and purified water to make up the difference. The compound contains 1.05 parts of water-soluble antibacterial components, specifically: 0.2 parts of polyhexamethylene guanidine hydrochloride, 0.15 parts of ε-polylysine hydrochloride, and 0.7 parts of quaternized sodium hyaluronate. The mass ratio of polyhexamethylene guanidine hydrochloride to ε-polylysine hydrochloride is 1.33:1, and the mass of quaternized sodium hyaluronate is twice the total mass of the two. The preparation method of the quaternized sodium hyaluronate is as follows: S01 Raw material preparation: Take medical grade sodium hyaluronate (molecular weight 120000Da), 2,3-epoxypropyltrimethylammonium chloride, isopropanol, sodium hydroxide, hydrochloric acid, and purified water; SO2 pretreatment: Sodium hyaluronate is added to purified water, the temperature is controlled at 40℃, the stirring speed is 200r / min, and the stirring is carried out for 40min until it is completely dissolved, so as to obtain a sodium hyaluronate aqueous solution with a mass concentration of 5%. Sodium hydroxide is added to adjust the pH value of the system to 10.0, and the system is kept at the temperature for 15min to activate it. SO3 Quaternization reaction: Isopropanol was added to the activated sodium hyaluronate aqueous solution at a volume ratio of 1:2. After stirring evenly, 2,3-epoxypropyltrimethylammonium chloride was slowly added dropwise at a mass ratio of 0.6:1 to sodium hyaluronate. After the addition was complete, the temperature was raised to 60°C and the reaction was maintained at this temperature with stirring for 4 hours. The stirring speed was maintained at 220 r / min. The reaction was stopped when the degree of substitution reached 0.5. SO4 purification: Adjust the pH of the system to 7.0 with hydrochloric acid, pour the reaction solution into acetone, stir evenly, let stand for 20 min, precipitate, filter and collect the precipitate; wash the precipitate 3 times with isopropanol, centrifuge after each wash (4000 r / min, 10 min) to remove residual impurities. S05 Drying and Pulverizing: Place the washed precipitate in a vacuum drying oven, control the drying temperature at 55℃ and the vacuum degree at -0.08MPa, dry for 12 hours until the moisture content is ≤0.5%, then pulverize to 100 mesh, and after sieving, obtain a white powdery quaternized sodium hyaluronate product, which is sealed and stored for later use.

[0036] Preparation steps: S1 Weigh the purified water according to the formula, add it to the sterile mixing tank, heat it to 50°C, start stirring, control the speed at 350 r / min, slowly add carbomer and xanthan gum, stir for 35 min until completely dispersed, without clumping or dry powder particles, continue to keep warm and swell for 2.5 h to obtain a uniform and transparent aqueous matrix. S2 maintains the temperature of the mixing tank at 50℃ and the stirring speed at 350r / min. Glycerin, polyethylene glycol 400, methylparaben, and propylparaben are added sequentially to the aqueous matrix of S1. Continue to keep warm and stir for 25min until all materials are completely dissolved, the system is uniform and transparent, and the mixture A is obtained. S3. While maintaining a stirring speed of 350 r / min, slowly add triethanolamine dropwise to the mixture A from S2. After the addition is complete, continue stirring for 20 min to neutralize the system until the pH value is 6.8. The carbomer completely swells to form a uniform and transparent gel system, thus obtaining the basic lubricating gel. S4. Cool the mixing tank to room temperature (25°C), adjust the stirring speed to 220 r / min, add polyhexamethylene guanidine hydrochloride, ε-polylysine hydrochloride, and the quaternized sodium hyaluronate prepared above to the basic lubricating gel in S3, stir for 35 min until completely dissolved, then turn on the homogenizer, control the homogenization speed to 1800 r / min, homogenize for 12 min, and vacuum degas for 25 min to obtain the water-soluble antibacterial lubricating composition.

[0037] Application Examples of Antibacterial Lubricating Cloth Application Example 1 The water-soluble antibacterial lubricating composition prepared in Example 1 was added to a sterile impregnation tank. A medical spunbond nonwoven fabric with a size of 10cm×15cm and a basis weight of 40g / ㎡ was completely immersed in the composition for 20s. After being removed, it was hung vertically for 30s to drain excess free liquid. Then, it was sealed in a sterile aluminum foil bag and sterilized with ethylene oxide to obtain the antibacterial lubricating fabric.

[0038] Application Example 2 The water-soluble antibacterial lubricating composition prepared in Example 2 was added to a sterile impregnation tank. A medical spunbond nonwoven fabric with a size of 8cm×12cm and a weight of 40g / ㎡ was completely immersed in the composition for 15s. After being removed, it was hung vertically for 30s to drain excess free liquid. Then, it was sealed in a sterile aluminum foil bag and sterilized with ethylene oxide to obtain the antibacterial lubricating fabric.

[0039] Application Example 3 The water-soluble antibacterial lubricating composition prepared in Example 3 was added to a sterile impregnation tank. A medical spunbond nonwoven fabric with a specification of 12cm×18cm and a basis weight of 40g / ㎡ was completely immersed in the composition for 30s. After being taken out, it was hung vertically for 30s to drain excess free liquid. Then, it was sealed and packaged in a sterile aluminum foil bag and sterilized with ethylene oxide to obtain the antibacterial lubricating fabric.

[0040] Comparative Example 1 The water-soluble lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, which is completely consistent with Example 1; no compound water-soluble antibacterial components are added.

[0041] The preparation steps are exactly the same as in Example 1, except that the step of adding the antibacterial component in S4 is omitted.

[0042] Comparative Example 2 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component was 100 parts, which was completely consistent with Example 1; the antibacterial component was only added with 0.75 parts of polyhexamethylene guanidine hydrochloride (consistent with the total mass of the antibacterial component in Example 1).

[0043] The preparation steps are exactly the same as in Example 1.

[0044] Comparative Example 3 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component was 100 parts, which was completely consistent with Example 1; the antibacterial component was supplemented with only 0.75 parts of ε-polylysine hydrochloride (consistent with the total mass of the antibacterial component in Example 1).

[0045] The preparation steps are exactly the same as in Example 1.

[0046] Comparative Example 4 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component was 100 parts, which was completely consistent with Example 1; the antibacterial component only had 0.75 parts of quaternized sodium hyaluronate added (consistent with the total mass of the antibacterial component in Example 1).

[0047] The preparation steps are exactly the same as in Example 1.

[0048] Comparative Example 5 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, which is completely consistent with that in Example 1; the antibacterial component is: 0.1 parts of ε-polylysine hydrochloride and 0.65 parts of quaternized sodium hyaluronate (the total mass is consistent with the total mass of the antibacterial component in Example 1).

[0049] The preparation steps are exactly the same as in Example 1.

[0050] Comparative Example 6 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, which is completely consistent with that in Example 1; the antibacterial component is: 0.15 parts of polyhexamethylene guanidine hydrochloride and 0.6 parts of quaternized sodium hyaluronate (the total mass is consistent with the total mass of the antibacterial component in Example 1).

[0051] The preparation steps are exactly the same as in Example 1.

[0052] Comparative Example 7 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, which is completely consistent with Example 1; the antibacterial component is: 0.15 parts of polyhexamethylene guanidine hydrochloride, 0.1 parts of ε-polylysine hydrochloride, and 0.5 parts of purified water (the total mass is consistent with the total mass of the antibacterial component in Example 1, and the amount is made up with purified water).

[0053] The preparation steps are exactly the same as in Example 1.

[0054] Comparative Example 8 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, which is completely consistent with Example 1; the antibacterial component is: 0.6 parts of polyhexamethylene guanidine hydrochloride, 0.05 parts of ε-polylysine hydrochloride, and 0.1 parts of quaternized sodium hyaluronate.

[0055] The preparation steps are exactly the same as in Example 1.

[0056] Comparative Example 9 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, which is completely consistent with Example 1; the antibacterial component is: 0.15 parts of polyhexamethylene guanidine hydrochloride, 0.1 parts of ε-polylysine hydrochloride, and 0.5 parts of ordinary sodium hyaluronate.

[0057] The preparation steps are exactly the same as in Example 1.

[0058] Comparative Example 10 The water-soluble antibacterial lubricating composition of this comparative example is formulated as follows: The basic lubricating component was 100 parts, which was completely consistent with Example 1; the antibacterial component was only 0.75 parts of chlorhexidine gluconate.

[0059] The preparation steps are exactly the same as in Example 1.

[0060] Comparative Example 11 The water-soluble lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, specifically: 20 parts glycerin, 0.3 parts carbomer, 10 parts polyethylene glycol 400, 0.35 parts triethanolamine, 0.1 parts methylparaben, 0.05 parts propylparaben, and 69.2 parts purified water; the compounded water-soluble antibacterial component is completely consistent with that in Example 1.

[0061] The preparation steps are exactly the same as in Example 1.

[0062] Comparative Example 12 The water-soluble lubricating composition of this comparative example is formulated as follows: The basic lubricating component is 100 parts, specifically: 20 parts glycerin, 1.0 part carbomer, 0.15 parts xanthan gum, 10 parts polyethylene glycol 400, 1.2 parts triethanolamine, 0.1 parts methylparaben, 0.05 parts propylparaben, and 67.5 parts purified water; the compounded water-soluble antibacterial component is completely consistent with that in Example 1.

[0063] The preparation steps are exactly the same as in Example 1.

[0064] Performance testing The performance of the samples from the above embodiments and comparative examples was tested in the following. All testing methods strictly followed relevant national standards and industry specifications, and the test data were the average values ​​of 3-5 parallel tests.

[0065] 1. Detection Method 1.1 Basic Physicochemical Properties Testing Appearance inspection: Visually inspect the appearance of the sample and record whether it is uniform, transparent, and free from phenomena such as layering, sedimentation, discoloration, and suspended matter; pH value test: The pH value was determined according to the General Chapter 0631 pH value determination method in the 2025 edition of the Pharmacopoeia of the People's Republic of China. The test temperature was 25℃, and the test was performed in parallel for 3 times. The average value was taken. Viscosity testing: A rotational viscometer was used to test the viscosity according to the third method of General Chapter 0633 of the 2025 edition of the Pharmacopoeia of the People's Republic of China. The test temperature was 25℃, the rotor model was RV-4, the rotation speed was 20 r / min, and three parallel tests were performed. The average value was taken and the dynamic viscosity (mPa·s) was recorded.

[0066] 1.2 Lubrication performance testing (dynamic friction coefficient test) A friction and wear testing machine was used to simulate the frictional environment between a urinary catheter and the urethral mucosa, and the dynamic friction coefficient of the samples was tested. Test conditions: The friction pair consisted of a medical latex catheter segment and fresh isolated porcine bladder mucosa (wetted with physiological saline); the load was 2N; the sliding speed was 10mm / s; the sliding distance was 50mm; and the test temperature was 37℃ (human body temperature).

[0067] Test method: Take 0.5g of sample and spread it evenly on the surface of the catheter segment. Test each group of samples in parallel 5 times and take the average value. The lower the coefficient of dynamic friction, the better the lubrication performance.

[0068] 1.3 Antibacterial performance test The tests were conducted according to Appendix C of GB15979-2002 "Hygienic Standard for Disposable Sanitary Products". The tested strains were the core pathogens of clinical catheter-related infections: Escherichia coli ATCC25922, Staphylococcus aureus ATCC6538, Pseudomonas aeruginosa ATCC9027, and Candida albicans ATCC10231.

[0069] Test method: After the sample is in contact with the bacterial solution for 2 minutes, the number of viable bacteria is measured, and the sterilization rate is calculated. Each group of samples is tested in triplicate, and the average value is taken. Sterilization rate calculation formula: Sterilization rate (%) = (Number of viable bacteria in control group - Number of viable bacteria in experimental group) / Number of viable bacteria in control group × 100% 1.4 Stability Testing Thermal stability test: The sample was sealed in a brown glass bottle and placed in a constant temperature incubator at 54℃ for 14 days. Samples were taken on day 0 and day 14 to test the appearance, pH value, viscosity, and E. coli sterilization rate. The viscosity change rate and sterilization rate decay rate were calculated. Viscosity change rate (%) = |Viscosity after test - Initial viscosity| / Initial viscosity × 100% Sterilization rate decay rate (%) = Initial sterilization rate - Sterilization rate after test Cold storage stability test: The sample was sealed in a brown glass bottle and placed in a -15℃ low temperature freezer for 14 days. After thawing, the appearance, pH value and viscosity were tested, and the presence of layering, precipitation and demulsification were recorded. High and low temperature cycling stability test: The sample was sealed in a brown glass bottle and placed in a high and low temperature alternating test chamber. Cycling conditions: -20℃ for 12 hours and 40℃ for 12 hours constituted one cycle. A total of 5 cycles were performed. After the cycle, the appearance, pH value and viscosity were measured. Light stability test: The sample was sealed in a transparent glass bottle and placed in a light test chamber with a light intensity of 4500 lux ± 500 lux and a temperature of 25℃ for 10 consecutive days. The appearance, pH value, viscosity, and E. coli sterilization rate were tested, and the viscosity change rate and sterilization rate decay rate were calculated.

[0070] 1.5 Testing of bonding performance with medical nonwoven fabrics The nonwoven fabric used for testing was a medical spunbond nonwoven fabric with a size of 5cm×5cm and a weight of 40g / ㎡. Liquid holding capacity test: Weigh the initial mass m0 of the nonwoven fabric, immerse it completely in the sample for 20s, remove it and hang it vertically for 30s, weigh the mass m1, perform 5 parallel tests and take the average value; Liquid holdup (%) = (m1 - m0) / m0 × 100% Drip test: Take the above-impregnated non-woven fabric, hang it vertically on clean filter paper for 5 minutes, observe whether there are any droplet marks on the filter paper, and record the dripping situation; Friction Residue Rate Test: Take the above-impregnated nonwoven fabric, fix it on the fixture of the friction and wear tester, and conduct a friction test with the pig bladder mucosa. The friction conditions are the same as in 1.2, and the number of friction cycles is 10. After the friction is completed, weigh the nonwoven fabric mass m2. Perform 5 parallel tests and take the average value. Friction residue rate (%) = (m2 - m0) / (m1 - m0) × 100% 1.6 Biocompatibility Testing Six healthy New Zealand white rabbits, half male and half female, were selected. The sample was injected into the rabbit urethra and administered once every 24 hours for 7 consecutive days. The animals were sacrificed 24 hours after the last administration, and urethral mucosal tissue was collected for pathological histological examination. The irritation index was calculated, and the irritation level was evaluated (irritation index ≤0.49 is non-irritating, 0.5-1.9 is very slight irritation, 2.0-4.9 is mild irritation, 5.0-8.9 is moderate irritation, and 9.0-11.0 is severe irritation).

[0071] 2. Test Results Table 1 Initial physicochemical property test results of each embodiment and comparative example Table 2 shows the test results of the dynamic friction coefficients of each embodiment and comparative example. Table 3. Results of 2-minute contact sterilization rate (%) for each embodiment and comparative example Table 4. Stability test results of each embodiment and comparative example after 14 days of heat storage at 54℃. Table 5. Stability test results of each embodiment and comparative example under 4500 lux light exposure for 10 days. Table 6. Test results of the bonding performance of each embodiment and comparative example with medical nonwoven fabric. Table 7 Results of rabbit urethral mucosal irritation tests for each embodiment and comparative example. The above application examples were tested and found that the prepared antibacterial lubricating cloth passed the sterility test after sterilization. After being stored for 12 months within the shelf life, the nonwoven fabric still maintained a uniformly wetted state, with no leakage or dripping. The lubricating and antibacterial properties did not significantly decrease, fully meeting the requirements for clinical catheterization.

[0072] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A water-soluble antibacterial lubricating composition, characterized in that, By weight, it includes the following components: 100 parts of basic lubricating component and 0.17-1.3 parts of compounded water-soluble antibacterial component; The basic lubricating components, by weight, include: 10-30 parts glycerin, 0.1-0.5 parts carbomer, 0.05-0.3 parts xanthan gum, 5-15 parts polyethylene glycol 400, 0.1-0.6 parts triethanolamine, 0.05-0.2 parts methylparaben, 0.02-0.1 parts propylparaben, and 50-80 parts purified water; The compounded water-soluble antibacterial components, by weight, include: 0.05-0.3 parts of polyhexamethylene guanidine hydrochloride, 0.02-0.2 parts of ε-polylysine hydrochloride, and 0.1-0.8 parts of quaternized sodium hyaluronate; The preparation method of the quaternized sodium hyaluronate is as follows: take medical grade sodium hyaluronate, dissolve it in purified water for activation, add isopropanol and quaternization reagent to carry out quaternization reaction, and after the degree of substitution reaches the standard, purify, dry, pulverize and sieve to obtain the product.

2. The water-soluble antibacterial lubricating composition according to claim 1, characterized in that, The basic lubricating components, by weight, include: 15-25 parts glycerin, 0.2-0.4 parts carbomer, 0.1-0.2 parts xanthan gum, 8-12 parts polyethylene glycol 400, 0.2-0.5 parts triethanolamine, 0.08-0.15 parts methylparaben, 0.03-0.08 parts propylparaben, and 60-75 parts purified water.

3. The water-soluble antibacterial lubricating composition according to claim 1, characterized in that, The compound water-soluble antibacterial components, by weight, include: 0.1-0.2 parts of polyhexamethylene guanidine hydrochloride, 0.05-0.15 parts of ε-polylysine hydrochloride, and 0.3-0.6 parts of quaternized sodium hyaluronate.

4. The water-soluble antibacterial lubricating composition according to claim 1, characterized in that, The mass ratio of polyhexamethylene guanidine hydrochloride to ε-polylysine hydrochloride is (1-3):

1.

5. The water-soluble antibacterial lubricating composition according to claim 1, characterized in that, The mass of the quaternized sodium hyaluronate is 2-5 times the total mass of polyhexamethylene guanidine hydrochloride and ε-polylysine hydrochloride.

6. The water-soluble antibacterial lubricating composition according to claim 1, characterized in that, The composition has a pH value of 5.5-7.0 and a dynamic viscosity of 8000-20000 mPa·s at 25°C.

7. A method for preparing the water-soluble antibacterial lubricating composition according to any one of claims 1-6, characterized in that, Includes the following steps: S1 Weigh out purified water, heat it to 40-50℃, add carbomer and xanthan gum, stir until completely dispersed and swollen to obtain an aqueous matrix; S2 adds glycerol, polyethylene glycol 400, methylparaben, and propylparaben to the aqueous matrix of S1, and keeps warm and stirs until completely dissolved to obtain mixture A; S3 adds triethanolamine to mixture A of S2 and stirs to neutralize to pH 5.5-7.0 to obtain a basic lubricating gel; S4 adds a compounded water-soluble antibacterial component to the basic lubricating gel of S3, stirs at room temperature until completely dissolved, homogenizes and degassing to obtain the water-soluble antibacterial lubricating composition.

8. The use of the water-soluble antibacterial lubricating composition according to any one of claims 1-6 in medical lubricating cloth.

9. An antibacterial lubricating cloth, characterized in that, It includes a medical nonwoven fabric carrier and the water-soluble antibacterial lubricating composition of any one of claims 1-6 loaded on the medical nonwoven fabric carrier.

10. The method for preparing the antibacterial lubricating cloth according to claim 9, characterized in that, Includes the following steps: The medical nonwoven fabric is completely immersed in the water-soluble antibacterial lubricating composition for 10-30 seconds. After immersion, excess free liquid is drained off, and the fabric is aseptically sealed and packaged to obtain the antibacterial lubricating fabric.

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