Medical sodium carboxymethyl cellulose flushing fluid

Abstract

The invention relates to the technical field of medical apparatus and instruments, in particular to a medical sodium carboxymethyl cellulose flushing fluid which comprises sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium citrate and / or citric acid, sodium chloride / potassium chloride and water for injection, has various excellent characteristics, is non-toxic, non-irritant and non-immune antigenicity to human bodies, and can be used for preparing the medical sodium carboxymethyl cellulose flushing fluid. The hydrogel has good biocompatibility, can be completely decomposed and metabolized in a body, has good safety, has an effect of preventing tissue adhesion, and can protect normal biological activity of tissues, relieve stimulation and promote repair of epithelium, mucosa and tissue wounds.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a medical sodium carboxymethyl cellulose irrigation solution. BACKGROUND

[0002] In the field of clinical medicine, the wound surface or surgical incision needs to be irrigated. The physiological saline is commonly used in clinical application. However, the conventional physiological saline irrigation can only flush the wound surface or incision, and cannot promote healing and prevent adhesion. Therefore, many patients have delayed healing of postoperative incision and wound surface, and even postoperative adhesion, which causes great pain to the patients.

[0003] At present, with the progress of medicine, researchers add chitosan or its derivatives to physiological saline to promote the formation of granulation and tissue, have the effects of coagulation, anti-inflammatory and anti-exudation, and can be used for irrigation or wet compress of animal large-area open wounds. However, chitosan and its derivatives still have disadvantages. On the one hand, chitosan and its derivatives are animal-derived raw materials, which can produce an immune response in the body. Before use, skin test detection must be performed. On the other hand, chitosan and its derivatives have a slow degradation rate in the body. It takes about three to four weeks to completely degrade and absorb. Therefore, some people use carboxymethyl cellulose sodium obtained from plant sources to replace chitosan or its derivatives. Carboxymethyl cellulose sodium does not produce an immune response in the body, has a fast degradation rate, and has a better film-forming effect. It can be completely degraded and absorbed in about one to two weeks. However, the irrigation solution prepared by directly replacing chitosan with carboxymethyl cellulose sodium has poor antibacterial effect and poor irrigation effect on the coagulated blood clots on the wound or surgical incision. Therefore, there is an urgent need for a medical carboxymethyl cellulose sodium irrigation solution that can efficiently inhibit bacteria and quickly flush away coagulated blood clots. SUMMARY

[0004] The present application aims to provide a medical sodium carboxymethyl cellulose irrigation solution to solve the problems in the background art. The specific technical scheme is as follows:

[0005] To achieve the above-mentioned objects and other related objects, the present application provides a medical sodium carboxymethyl cellulose irrigation solution. The composition of the irrigation solution comprises sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium citrate and / or citric acid, sodium chloride / potassium chloride, and water for injection. The composition mass formula is as follows:

[0006]

[0007] Preferably, the composition mass formula of the irrigation solution is as follows:

[0008]

[0009] Preferably, the pH value of the irrigation solution is between 4 and 8.

[0010] Preferably, the flushing liquid composition further comprises glycerol.

[0011] Preferably, the flushing liquid composition further comprises propylene glycol.

[0012] Preferably, the glycerol is present in a mass ratio of 0.1-50 parts, more preferably in a mass ratio of 1-30 parts, and most preferably in a mass ratio of 5-20 parts.

[0013] Preferably, the propylene glycol is present in a mass ratio of 0.1-50 parts, more preferably in a mass ratio of 0.5-30 parts, and most preferably in a mass ratio of 1-10 parts.

[0014] Preferably, the flushing liquid composition further comprises phosphate, including but not limited to sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, and dipotassium hydrogen phosphate, which can be added as a single component or a combination of two or more components.

[0015] Preferably, the phosphate salt is present in a mass ratio (in terms of phosphate ions) of 0.1-50 parts, more preferably in a mass ratio of 0.3-35 parts, and most preferably in a mass ratio of 0.8-25 parts.

[0016] Preferably, the osmotic pressure of the flushing liquid is in the range of 250-350 mOsm / kg, and more preferably in the range of 270-330 mOsm / kg.

[0017] The medical sodium carboxymethyl cellulose flushing liquid provided by the present application has the following beneficial effects: compared with chitosan, sodium carboxymethyl cellulose, as a plant source raw material, has many excellent properties, is non-toxic, non-irritating, and non-immunogenic to the human body, has good biocompatibility, can be completely decomposed and metabolized in the body, and has good safety. It has the effects of preventing tissue adhesion, protecting the normal biological activity of tissues, relieving irritation, and promoting the repair of epithelium, mucosa, and tissue wounds. By adding sodium dodecanol sulfate, citric acid, and / or sodium citrate, metal ions and sodium in the extracellular polysaccharide matrix can be chelated, sodium dodecanol sulfate can reduce the surface biological end tension and lyse bacterial cells, thereby achieving a synergistic antibacterial effect. The sodium carboxymethyl cellulose forms a film structure on the incision surface, has a surprising synergistic effect, and has a very excellent effect on antibacterial ability compared with a flushing liquid using sodium carboxymethyl cellulose alone, a flushing liquid using pueraria polysaccharide alone, and physiological saline. Sodium dodecanol sulfate, as a surfactant, has good wetting, floating, and decontamination foaming properties, and greatly improves the flushing effect on impurities such as clotted blood. DETAILED DESCRIPTION

[0018] The following will further illustrate in detail a medical sodium carboxymethyl cellulose irrigating solution according to the present application in connection with specific examples. The advantages and features of the present application will be more apparent according to the following description.

[0019] Example 1

[0020] Formulation:

[0021]

[0022] Preparation method: sodium carboxymethyl cellulose, sodium lauryl sulfate and sodium citrate are weighed according to the above formulation, mixed and stirred to dissolve in 1L of injection water, the mixed solution is filtered, sterilely filled, sterilized by high pressure steam at 115°C for 30 minutes to obtain the finished product of the irrigating solution.

[0023] Example 2

[0024] Formulation:

[0025]

[0026] Preparation method: sodium carboxymethyl cellulose, sodium lauryl sulfate and citric acid are weighed according to the above formulation, mixed and stirred to dissolve in 1L of injection water, the mixed solution is filtered, sterilely filled, sterilized by high pressure steam at 115°C for 30 minutes to obtain the finished product of the irrigating solution.

[0027] Example 3

[0028] Formulation:

[0029]

[0030] Preparation method: sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium citrate and citric acid are weighed according to the above formulation, mixed and stirred to dissolve in 1L of injection water, the mixed solution is filtered, sterilely filled, sterilized by high pressure steam at 115°C for 30 minutes to obtain the finished product of the irrigating solution.

[0031] Example 4

[0032] Formulation:

[0033]

[0034] Preparation method: sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium citrate and citric acid are weighed according to the above formulation, mixed and stirred to dissolve in 1L of injection water, the mixed solution is filtered, sterilely filled, sterilized by high pressure steam at 115°C for 30 minutes to obtain the finished product of the irrigating solution.

[0035] Example 5

[0036] formula:

[0037]

[0038] Preparation method: Weigh out sodium carboxymethyl cellulose, sodium dodecyl sulfate, sodium citrate, and citric acid according to the above formula, mix and stir to dissolve in 1L of water for injection, filter the mixed solution by suction filtration and fine filtration, aseptically fill the solution, and sterilize it by high pressure steam at 115℃ for 30 minutes to obtain the finished rinsing solution.

[0039] Example 6

[0040] formula:

[0041]

[0042] Preparation method: Weigh out sodium carboxymethyl cellulose, sodium dodecyl sulfate, sodium citrate, and citric acid according to the above formula, mix and stir to dissolve in 1L of water for injection, filter the mixed solution by suction filtration and fine filtration, aseptically fill the solution, and sterilize it by high pressure steam at 115℃ for 30 minutes to obtain the finished rinsing solution.

[0043] Comparative Example 1

[0044] Dissolve 9g of sodium chloride in 1L of water for injection and use it as a rinsing solution.

[0045] Comparative Example 2

[0046] formula:

[0047] 60g of sodium carboxymethyl cellulose;

[0048] 6g of sodium chloride;

[0049] 1L of water for injection.

[0050] Preparation method: Weigh out sodium carboxymethyl cellulose and sodium chloride according to the above formula, mix and stir to dissolve in 1L of water for injection, filter the mixed solution by suction filtration and fine filtration, aseptically fill the solution, and sterilize it by high pressure steam at 115℃ for 30 minutes to obtain the finished rinsing solution.

[0051] Comparative Example 3

[0052] formula:

[0053] 60g of water-soluble chitosan;

[0054] 8g of sodium chloride;

[0055] 1L of water for injection.

[0056] Preparation method: Weigh water-soluble chitosan and sodium chloride according to the above formula, mix and stir to dissolve in 1L of water for injection, filter and fine filter the mixed solution and then aseptically fill it, sterilize it with high pressure steam at 115℃ for 30 minutes to obtain the finished rinsing solution.

[0057] Comparative Example 4

[0058] formula:

[0059] 50g of sodium carboxymethyl cellulose;

[0060] 10g of sodium lauryl sulfate;

[0061] 1L of water for injection.

[0062] Preparation method: Weigh out sodium carboxymethyl cellulose and sodium dodecyl sulfate according to the above formula, mix and stir to dissolve in 1L of water for injection, filter the mixed solution by suction filtration and fine filtration, aseptically fill the solution, and sterilize it by high pressure steam at 115℃ for 30 minutes to obtain the finished rinsing solution.

[0063] Comparative Example 5

[0064] formula:

[0065]

[0066] Preparation method: Weigh out sodium carboxymethyl cellulose, sodium citrate, and citric acid according to the above formula, mix and stir to dissolve in 1L of water for injection, filter the mixed solution by suction filtration and fine filtration, aseptically fill the solution, and sterilize it by high pressure steam at 115℃ for 30 minutes to obtain the finished rinsing solution.

[0067] Experimental Example 1

[0068] The products prepared in Examples 1-6 and Comparative Examples 1-5 were compared in a test. After shaving the test mice, a surgical incision 2 cm long and 0.5 cm deep was made on the back of the test mice. The surgical incision was then cleaned with the products prepared in Examples 1-6 and Comparative Examples 1-5, and the rinsing effect was observed.

[0069] Table 1. Comparative tests of the products prepared in Examples 1-6 and Comparative Examples 1-5

[0070]

[0071] As shown in Table 1, compared with Comparative Examples 1-5, Examples 1-6 resulted in more thorough wound cleaning with no blood, blood clots, or other impurities remaining. Compared with Comparative Example 5, Example 4, which added sodium lauryl sulfate, exhibited better wetting, flocculation, decontamination, and foaming properties, achieving a superior cleaning effect. Since water-soluble chitosan is an animal-derived product, it can cause immune rejection and slow degradation in vivo, potentially leading to inflammatory reactions. In contrast, sodium carboxymethyl cellulose is a plant-derived product with better biocompatibility, superior moisturizing properties, providing a suitable moist healing environment for the wound and promoting healing. It also effectively prevents bleeding and reduces the exudation of inflammatory mediators.

[0072] Experimental Example 2

[0073] The products prepared in Examples 1-6 and Comparative Examples 1-5 were subjected to antibacterial tests. The antibacterial test method was as follows: Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Aspergillus niger, and yeast were inoculated onto slant culture medium and cultured for 24 h. The bacterial groups on the slant culture medium were washed with PBS buffer and diluted to prepare bacterial suspension. 20 ml of washing solution was poured onto a sterile degreased cloth with a diameter of 3 cm. 0.5 ml of bacterial suspension of each strain was dropped onto the sterile degreased cloth and cultured at 30 °C for 30 min, 60 min, and 300 min. The film formed by the washing solution was carefully peeled off with tweezers. The bacterial degreased cloth was soaked in 10 ml of PBS buffer and washed thoroughly. 1 ml of the solution was then inoculated and cultured. Viable bacteria were counted. Comparative Example 1 was used as a blank control group, and the antibacterial rate was calculated.

[0074] Table 2. Results of the 30-minute antibacterial test on the products prepared in Examples 1-6 and Comparative Examples 1-5.

[0075]

[0076] Table 3. Results of the 60-minute antibacterial test on the products prepared in Examples 1-6 and Comparative Examples 1-5.

[0077]

[0078]

[0079] Table 4. Results of the 300-minute antibacterial test on the products prepared in Examples 1-6 and Comparative Examples 1-5.

[0080]

[0081] As shown in Tables 2-4, the rinsing solutions prepared in Examples 1-6 have good antibacterial effects. After 5 hours, the rinsing solutions prepared in Examples 4-6 can still maintain 99.9% antibacterial effect. The film-forming properties of sodium carboxymethyl cellulose and the synergistic effect of citric acid and sodium citrate achieve long-lasting bacterial protection. At the same time, they effectively inhibit a variety of fungi and bacteria, demonstrating excellent broad-spectrum antibacterial efficacy.

[0082] Experimental Example 3

[0083] The products prepared in Examples 1-6 were subjected to safety testing.

[0084] Referring to GB / T 16886.5-2022 and GB / T 16886.10-2012, which were developed based on the biological safety evaluation standard GB / T 16886.1-2022 Medical Device Biological Evaluation - Part 1: Evaluation and Testing in the Risk Management Process, the following tests were conducted on the product: 1. Cytotoxicity; 2. Sensitization; 3. Irritation or intradermal reaction; 4. Material-mediated pyrogenicity; 5. Acute systemic toxicity.

[0085] The product test results of Examples 1-6 were all passed. The sodium carboxymethyl cellulose, sodium dodecyl sulfate, citric acid and sodium citrate used were all non-irritating, would not react with commonly used surgical implants, and had strong compatibility.

[0086] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A medical-grade sodium carboxymethyl cellulose rinsing solution, characterized in that, The rinsing solution comprises: sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium citrate and / or citric acid, sodium chloride / potassium chloride, and water for injection, with the following composition and mass formula:

2. The medical carboxymethyl cellulose sodium rinsing solution according to claim 1, characterized in that, The composition and mass formula of the rinsing solution are as follows:

3. A medical carboxymethyl cellulose sodium rinsing solution according to claim 1 or 2, characterized in that, The pH value of the rinsing solution is between 4 and 8.

4. The medical carboxymethyl cellulose sodium rinsing solution according to claim 3, characterized in that, The rinsing solution also includes glycerin.

5. The medical carboxymethyl cellulose sodium rinsing solution according to claim 4, characterized in that, The rinsing solution also includes propylene glycol.

6. The medical carboxymethyl cellulose sodium rinsing solution according to claim 3, characterized in that, The glycerol mass ratio is 0.1-50 parts, more preferably 1-30 parts, and most preferably 5-20 parts.

7. The medical carboxymethyl cellulose sodium rinsing solution according to claim 4, characterized in that, The mass ratio of propylene glycol is 0.1-50 parts, more preferably 0.5-30 parts, and most preferably 1-10 parts.

8. A medical carboxymethyl cellulose sodium rinsing solution according to claim 1 or 2, characterized in that, The rinsing solution also includes phosphates, including but not limited to sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, and dipotassium hydrogen phosphate. When added, a single component or a combination of two or more components can be selected.

9. The medical carboxymethyl cellulose sodium rinsing solution according to claim 8, characterized in that, The mass ratio of the buffer salt (based on phosphate ions) is 0.1-50 parts, more preferably 0.3-35 parts, and optimally 0.8-25 parts.

10. A medical carboxymethyl cellulose sodium rinsing solution according to claim 1 or 2, characterized in that, The osmolar concentration of the flushing solution is 250-350 mOsm / kg, and more preferably 270-330 mOsm / kg.

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