Efficient antibacterial carboxymethyl cellulose anti-adhesion flushing fluid and preparation method thereof
By adding benzalkonium chloride to sodium carboxymethyl cellulose rinsing solution and adjusting the pH value, a physical barrier is formed, which solves the problem of poor anti-inflammatory, antibacterial and anti-adhesion effects of existing rinsing solutions, achieving highly efficient antibacterial, anti-inflammatory and anti-adhesion effects, and improving biocompatibility.
Patent Information
- Application Number
- CN202410706633.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-06-03
- Publication Date
- 2025-12-05
AI Technical Summary
Existing flushing solutions are insufficient in terms of anti-inflammatory, antibacterial, and anti-adhesion effects. Traditional saline solutions have limited functions, animal-derived flushing solutions have poor biocompatibility, plant cellulose-based flushing solutions have poor anti-inflammatory effects, and biocompatibility issues still exist even after adding chitosan.
Adding benzalkonium chloride as an antibacterial component to sodium carboxymethyl cellulose rinsing solution and adjusting the pH to 5.5-6.5 utilizes the film-forming properties of sodium carboxymethyl cellulose to form a physical barrier, combined with the disinfecting effect of benzalkonium chloride, to achieve the effects of cleaning wounds and preventing tissue adhesion.
It achieves highly effective antibacterial and anti-inflammatory effects, improves biocompatibility, forms a physical barrier to prevent tissue adhesion, and provides a favorable environment for wound healing.
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Figure BDA0004872759170000051
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to a carboxymethyl cellulose anti-adhesion rinse solution. BACKGROUND
[0002] In the treatment of surgical trauma, mucosa or surgical incision, it is usually necessary to rinse and clean the wound, so as to improve the surgical field and the surgical environment. The market's rinse products are mainly divided into three categories: traditional physiological saline, rinse solution made of animal-derived materials such as chitosan, and rinse solution made of plant-derived materials such as sodium carboxymethyl cellulose. The traditional physiological saline has a single function and cannot achieve the effects of anti-inflammatory, antibacterial and anti-adhesion, and can only achieve a simple flushing and cleaning of the wound or incision; the rinse solution made of animal-derived materials has a certain antibacterial function, but generally has poor biocompatibility, causes allergic reactions and increases the risk of surgery; the rinse solution made of plant cellulose has good anti-adhesion effect, is non-toxic, non-irritating and non-immunogenic to the human body, and has good biocompatibility, but has poor anti-inflammatory and antibacterial effect. In order to increase the antibacterial and anti-inflammatory effect, some products add chitosan materials to the sodium carboxymethyl cellulose rinse solution, but still cannot solve the problem of poor biocompatibility caused by chitosan materials.
[0003] The present application adds benzalkonium chloride component to the sodium carboxymethyl cellulose rinse solution, the benzalkonium chloride solution can be used for skin disinfection before surgery, mucosa and wound disinfection, and after effective mixing of the two components in proportion, the effect of cleaning the wound and preventing tissue adhesion can be achieved, and the antibacterial and anti-inflammatory effect is also effectively increased. Through the film-forming property of the sodium carboxymethyl cellulose rinse solution, the antibacterial component is uniformly formed into a physical barrier on the tissue wound, and a favorable growth environment is provided for wound healing. Through patent search, there is no report on adding benzalkonium chloride to the sodium carboxymethyl cellulose rinse solution at home and abroad. SUMMARY
[0004] The present application provides a high-efficiency antibacterial carboxymethyl cellulose anti-adhesion rinse solution and a preparation method thereof. Through the film-forming property of the sodium carboxymethyl cellulose rinse solution, the antibacterial component is uniformly formed into a physical barrier on the tissue wound, and a favorable growth environment is provided for wound healing.
[0005] To achieve the above-mentioned purpose, the present application provides the following technical scheme: a high-efficiency antibacterial carboxymethyl cellulose anti-adhesion rinse solution and a preparation method thereof, according to weight percentage, including 5% of sodium carboxymethyl cellulose, 0.1% of benzalkonium chloride, 0.02% of glacial acetic acid, and the rest of ultrapure water.
[0006] Further, the sodium carboxymethyl cellulose uses a pharmaceutical grade dressing, the substitution degree is 0.59-1.0, and the viscosity is 6000 mPa.s.
[0007] Further, a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse and a preparation method thereof include the following steps:
[0008] (1) Disperse sodium carboxymethyl cellulose in ultrapure water, and stir completely to obtain solution A;
[0009] (2) Pour benzalkonium chloride into solution A, and fully stir and mix to obtain solution B;
[0010] (3) Add glacial acetic acid to adjust the pH value of solution B to 5.5-6.5;
[0011] (4) Take a sample to observe that there is no precipitate, and determine the pH value, viscosity performance, and film-forming performance; after passing the quality inspection, perform filling, sealing, high-temperature and high-humidity sterilization, and a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse is obtained.
[0012] Compared with the prior art, the present application provides a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse and a preparation method thereof, which have the following beneficial effects:
[0013] In research and development, the applicant found that the rinse products used in clinical practice all have corresponding deficiencies. Traditional normal saline has a single function and cannot achieve the effects of anti-inflammatory and antibacterial and anti-adhesion, and can only achieve a simple flushing and cleaning of the wound or incision; the rinse made of animal-derived raw materials has a certain antibacterial function, but generally has poor biocompatibility and has the risk of allergic reaction; the rinse made of plant cellulose has good anti-adhesion effect and good biocompatibility, but has poor anti-inflammatory and antibacterial effect; in order to increase the antibacterial and anti-inflammatory effect, some products add chitosan raw materials to the rinse made of sodium carboxymethyl cellulose, but still cannot solve the problem of poor biocompatibility caused by chitosan raw materials. The present application adds benzalkonium chloride component to the rinse made of sodium carboxymethyl cellulose; the formula selects benzalkonium chloride which can be used for skin disinfection before surgery, mucosa and wound disinfection as an antibacterial disinfectant component, has high safety, and after effective mixing of the two components in proportion, a physical barrier is formed on the tissue wound by the film-forming property of the sodium carboxymethyl cellulose rinse, which can achieve the effects of cleaning the wound, preventing tissue adhesion, and inhibiting bacteria and inflammation; the formula product has high safety and can provide a favorable growth environment for wound healing. DETAILED DESCRIPTION
[0014] Embodiment 1: A high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse solution, comprising, by weight percentage, sodium carboxymethyl cellulose 5%, benzalkonium chloride 0.1%, glacial acetic acid 0.02%, and the balance being ultrapure water. The sodium carboxymethyl cellulose uses a medicinal grade dressing with a degree of substitution of 0.59-1.0 and a viscosity of 6000 mPa.s.
[0015] The sodium carboxymethyl cellulose is dispersed in ultrapure water and stirred completely to obtain solution A; the benzalkonium chloride is poured into solution A and mixed and stirred completely to obtain solution B; the glacial acetic acid is added to adjust the pH value of solution B to between 5.5-6.5; a sample is observed for no precipitate, the pH value, viscosity performance, and film-forming performance are measured, and after passing the quality inspection, the solution is filled, sealed, and high-temperature and high-humidity sterilized to obtain a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse solution.
[0016] Control group 1: comprising, by weight percentage, sodium carboxymethyl cellulose 5%, glacial acetic acid 0.02%, and the balance being ultrapure water. The sodium carboxymethyl cellulose uses a medicinal grade dressing with a degree of substitution of 0.59-1.0 and a viscosity of 6000 mPa.s.
[0017] The sodium carboxymethyl cellulose is dispersed in ultrapure water and stirred completely to obtain solution A; the glacial acetic acid is added to adjust the pH value to between 5.5-6.5; a sample is observed for no precipitate, the pH value, viscosity performance, and film-forming performance are measured, and after passing the quality inspection, the solution is filled, sealed, and high-temperature and high-humidity sterilized to obtain a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse solution.
[0018] Control group 2: comprising, by weight percentage, carboxymethyl chitosan 5%, glacial acetic acid 0.02%, and the balance being ultrapure water.
[0019] The carboxymethyl chitosan is dispersed in ultrapure water and stirred completely to obtain solution A; the glacial acetic acid is added to adjust the pH value to between 5.5-6.5; a sample is observed for no precipitate, the pH value, viscosity performance, and film-forming performance are measured, and after passing the quality inspection, the solution is filled, sealed, and high-temperature and high-humidity sterilized to obtain a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse solution.
[0020] Control group 3: comprising, by weight percentage, sodium carboxymethyl cellulose 3%, carboxymethyl chitosan 2%, glacial acetic acid 0.02%, and the balance being ultrapure water.
[0021] The sodium carboxymethyl cellulose is dispersed in ultrapure water and stirred completely to obtain solution A; the carboxymethyl chitosan is dispersed in ultrapure water and stirred completely to obtain solution B; solution A and solution B are mixed and stirred completely; the glacial acetic acid is added to adjust the pH value to between 5.5-6.5; a sample is observed for no precipitate, the pH value, viscosity performance, and film-forming performance are measured, and after passing the quality inspection, the solution is filled, sealed, and high-temperature and high-humidity sterilized to obtain a high-efficiency bacteriostatic carboxymethyl cellulose anti-adhesion rinse solution.
[0022] The film-forming property, bacteriostasis and cytotoxicity tests were performed on the product of Example 1 and the products of the control groups, which were respectively single addition of sodium carboxymethyl cellulose, single addition of carboxymethyl chitosan, and simultaneous addition of sodium carboxymethyl cellulose and carboxymethyl chitosan.
[0023] Film-forming property test method: at a temperature of 20-25℃, the product was cast on a dry flat glass plate and naturally dried to form a transparent or translucent film.
[0024] Bacteriostasis test method: the test was performed according to the method described in WS / T 650-2019. If the diameter of the bacteriostasis ring of the test sample was >7mm, it was determined to have bacteriostasis; if the diameter of the bacteriostasis ring was ≤7mm, it was determined to have no bacteriostasis.
[0025] Cytotoxicity test method: the test was performed according to the method described in GB / T 16886.5-2017. The leaching liquid of the test sample was observed for obvious cytotoxicity to L-929 cells.
[0026] The experimental results are shown in Table 1.
[0027] Table 1
[0028]
[0029] Although embodiments of the present application have been shown and described, it is to be understood that various modifications, substitutions, replacements and variations can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.
Claims
1. A high bacteriostatic carboxymethyl cellulose anti-blocking rinse solution and a method for preparing the same, characterized in that, By weight percentage, including sodium carboxymethyl cellulose 5%, benzalkonium chloride 0.1%, glacial acetic acid 0.02%, the rest is ultrapure water.
2. A high bacteria-inhibiting carboxymethyl cellulose anti-blocking rinse solution and a method of preparing the same according to claim 1, characterized by, The sodium carboxymethyl cellulose uses pharmaceutical grade dressing, substitution degree 0.59-1.0, viscosity 6000 mPa.s.
3. A high bacteriostatic carboxymethyl cellulose anti-blocking rinse solution according to claims 1-2 and a method for preparing the same, characterized in that, Including the following steps: (1) Disperse sodium carboxymethyl cellulose in ultrapure water, stir completely to obtain solution A; (2) Pour benzalkonium chloride into solution A, mix well by stirring to obtain solution B; (3) Add glacial acetic acid to adjust the pH value of solution B to 5.5-6.5; (4) Take samples to observe the appearance without precipitation, measure the pH value, viscosity performance, film forming performance, and after passing the quality inspection, carry out filling, sealing, high temperature and humidity sterilization, to obtain a high-efficiency antibacterial carboxymethyl cellulose anti-adhesion rinse.