Seawater nasal cavity cleaning dressing and preparation method thereof

Abstract

The invention provides a seawater nasal cavity cleaning dressing which is particularly suitable for rhinitis patients. The dressing is composed of sea salt water and a specially prepared composite dispersion liquid. The composite dispersion liquid is a stable colloidal solution formed by magnesium lithium silicate with high specific surface area (gt; 350m / g) and sodium carboxymethyl cellulose with specific viscosity (600-5600mPa. S) through electrostatic interaction. Due to the high specific surface area of the magnesium lithium silicate, the adsorption capacity is high, and harmful substances such as pathogens and allergens in the nasal cavity can be effectively adsorbed; and the sodium carboxymethyl cellulose endows the composite dispersion liquid with excellent adhesion, so that the composite dispersion liquid can form a uniform and stable protective film on the nasal mucosa, and the residence time of the dressing in the nasal cavity is prolonged. Compared with a traditional seawater nasal cavity cleaning agent, the composite dispersion liquid of the dressing is unique in structure and higher in adsorption performance, the rhinitis symptom can be more effectively relieved, and the life quality of a patient is remarkably improved.

Description

Technical Field

[0001] The invention relates to the field of medicine and medical equipment, in particular to a seawater nasal cavity cleaning dressing for treating rhinitis. Background Art

[0002] Rhinitis is a common inflammatory disease of the nasal mucosa, and its incidence is high worldwide. In China, with the acceleration of industrialization and changes in the living environment, the number of rhinitis patients is also increasing year by year. Allergic rhinitis is one of the more common types, affecting up to 200 million Chinese people. Symptoms of rhinitis include sneezing, nasal congestion, itchy nose, runny nose, etc., which seriously affect the quality of life of patients.

[0003] The treatment and care of rhinitis face many challenges. First, the inflammatory response of the nasal mucosa may lead to a decrease in the mucosal barrier function and increase the risk of infection. Second, traditional seawater nasal cleaning dressings have limitations in cleaning effect and retention time, and often cannot keep the nasal cavity moist and clean for a long time, resulting in poor treatment effect. In addition, the repeated exposure of allergic rhinitis patients to allergens causes repeated symptoms and is difficult to effectively control.

[0004] Existing seawater nasal cleaning dressings have limitations in cleaning effect and retention time, and a new type of seawater nasal cleaning dressing is needed to improve the cleaning effect and prolong the retention time in the nasal cavity. In addition, existing seawater nasal cleaning solutions and nasal liquid dressings may not have good adsorption properties and cannot effectively adsorb and remove pathogens and allergens in the nasal cavity.

[0005] In addition, the sterile seawater nasal cleaning dressing that has been sterilized by radiation can also be used for postoperative care after the implantation of nasal hemostatic sponge, effectively removing residual blood and secretions, protecting the wound surface, and reducing the risk of infection. Summary of the invention

[0006] The present invention provides a seawater nasal cleaning dressing, which achieves better cleaning effect and longer retention time through specific components and preparation methods, thereby improving the nursing effect of rhinitis. The seawater nasal cleaning dressing of the present invention comprises sea salt, water, sodium carboxymethyl cellulose and lithium magnesium silicate, wherein the lithium magnesium silicate has a viscosity of more than 350 m 2 / g specific surface area, sodium carboxymethyl cellulose has a specific viscosity, these properties make the dressing have good adsorption performance and stability.

[0007] In view of the above problems, the object of the present invention is to provide a seawater nasal cleaning dressing, which is composed of the following components: sea salt water and a composite dispersion, wherein the composite dispersion contains: lithium magnesium silicate with a high specific surface area (>350 m² / g); sodium carboxymethyl cellulose with a specific viscosity (600-5600 mPa·s); the composite dispersion is a stable colloidal solution formed by electrostatic action, which is used to enhance the adhesion of the dressing, increase the residence time of the dressing in the nasal cavity, and has good adsorption and biocompatibility.

[0008] A method for preparing a seawater nasal cleaning dressing, characterized in that it comprises the following steps: (1) Preparing a composite dispersion: adding sodium carboxymethyl cellulose to water and stirring until completely dissolved to obtain solution A; adding lithium magnesium silicate to water and stirring at 40-80° C., cooling to room temperature to obtain solution B; adding solution B to solution A and stirring at high speed to obtain a sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion C; (2) Preparation of sea salt solution: Add sea salt to water and stir until completely dissolved to obtain solution D; (3) Mixing and adjusting pH: Add the composite dispersion C to solution D, stir evenly, then add a pH adjuster to adjust the pH value to weak acidity, and keep stirring to obtain a uniform dispersion; (4) Filling and sterilization: The uniform dispersion obtained is filled into a container and sterilized to obtain the seawater nasal cleaning dressing.

[0009] In the step (1), the ratio of sodium carboxymethyl cellulose to lithium magnesium silicate is 1:1-2.

[0010] The high-speed stirring speed in step (1) is 8000-12000 rpm.

[0011] The amount of sea salt in step (2) is calculated based on a final concentration of 0.9-2.3%.

[0012] The pH adjuster used in step (3) is at least one of hydrochloric acid, phosphoric acid, citric acid, malic acid, gluconic acid and lactic acid.

[0013] In the step (3), the pH value is adjusted to 3.0-6.5.

[0014] The sterilization method of step (4) is Co60 radiation sterilization, and the sterilization dose is 15-25 kGy.

[0015] The water in the seawater nasal cleaning dressing of the present invention is the basic component of the seawater nasal cleaning dressing, which can dilute and wash the impurities of nasal mucus. The various trace elements and minerals in the sea salt have certain bactericidal and anti-inflammatory effects. The pH regulator can ensure that the seawater nasal cleaning dressing is within the physiological pH range, thereby protecting the nasal mucosa from damage, helping the effective ingredients in the seawater nasal cleaning dressing to play a better role and improve the cleaning effect.

[0016] The sodium carboxymethylcellulose-lithium magnesium silicate composite dispersion of the present invention has the following characteristics: (1) Uniform dispersion: Sodium carboxymethyl cellulose and lithium magnesium silicate form a stable composite system through electrostatic interaction. The carboxylate ions on the molecular chain of sodium carboxymethyl cellulose are negatively charged, and they have strong electrostatic attraction with the positively charged magnesium ions on the surface of lithium magnesium silicate crystals, making the two evenly dispersed in the solution. Depending on the concentration, lithium magnesium silicate needs to be heated appropriately (40-80°C) to accelerate the formation of the dispersion.

[0017] (2) Adsorption: Lithium magnesium silicate has a unique layered structure with a negatively charged surface and a positively charged edge. This charge heterogeneity allows it to self-assemble in aqueous solution to form a hydrogel with a three-dimensional network structure. This structure not only provides a large specific surface area, but also has an uneven distribution of surface charge, which can effectively adsorb microorganisms such as bacteria and viruses with opposite charges. In addition, the layered structure of lithium magnesium silicate makes it easier for it to contact the surface of pathogens, thereby enhancing its ability to adsorb and remove pathogens.

[0018] Compared with the prior art, the seawater nasal cleaning dressing of the present invention has the following beneficial effects: By using high specific surface area (>350m 2 / g) of lithium magnesium silicate improves the adsorption performance of the cleaning dressing and can effectively adsorb and remove pathogens and allergens in the nasal cavity; The specific viscosity range of sodium carboxymethylcellulose ensures the stability and safety of the dressing and reduces irritation to the nasal mucosa; The formation of sodium carboxymethylcellulose-lithium magnesium silicate composite dispersion improves the distribution uniformity and residence time of the dressing in the nasal cavity, and enhances the nursing effect; Through the interaction of positive and negative charges, the adhesion of the dressing to the nasal mucosa is enhanced, thereby improving the care effect and reducing the recurrence of rhinitis symptoms. DETAILED DESCRIPTION

[0019] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0020] Example 1 A method for preparing a seawater nasal cleaning dressing is as follows: (1) 0.05 g of sodium carboxymethyl cellulose (labeled viscosity 800 mPa·s) was added to 100 mL of water and stirred until completely dissolved to obtain solution A. 0.1 g of lithium magnesium silicate (Laponite XLG-XR) was added to 200 mL of water and stirred at 40°C. The mixture was cooled to room temperature to obtain solution B. Solution B was added to solution A and stirred at 8000-10000 rpm to obtain sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion C. (2) Add 4.5 g of sea salt to 200 mL of water and stir until completely dissolved to obtain solution D. (3) adding the composite dispersion C to the solution D, stirring at room temperature, then adding a pH adjuster, citric acid, to adjust the pH value to 4.5, and continuing stirring to obtain a uniformly dispersed liquid, thereby obtaining the seawater nasal cleaning dressing; (4) Fill into a spray bottle and sterilize by 25kGy Co60 irradiation before use with the spray bottle. Example 2

[0021] (1) 0.5 g of sodium carboxymethyl cellulose (labeled viscosity 4000 mPa·s) was added to 100 mL of water and stirred until completely dissolved to obtain solution A. 0.5 g of lithium magnesium silicate (Laponite XLG-XR) was added to 200 mL of water and stirred at 80°C. The mixture was cooled to room temperature to obtain solution B. Solution B was added to solution A and stirred at 8000-10000 rpm to obtain sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion C. (2) Add 4.5 g of sea salt to 200 mL of water and stir until completely dissolved to obtain solution D. (3) adding the composite dispersion C to the solution D, stirring at room temperature, and then adding a pH adjuster 85% phosphoric acid to adjust the pH value to 5.5, and continuing stirring to obtain a uniformly dispersed liquid, thereby obtaining the seawater nasal cleaning dressing; (4) Fill into a spray bottle and sterilize by 25kGy Co60 irradiation before use with the spray bottle.

[0022] Example 3 (1) 2.5 g of sodium carboxymethyl cellulose (labeled viscosity 800 mPa·s) was added to 100 mL of water and stirred until completely dissolved to obtain solution A. 2.5 g of lithium magnesium silicate (Laponite XLG-XR) was added to 200 mL of water and stirred at 80°C. The mixture was cooled to room temperature to obtain solution B. Solution B was added to solution A and stirred at 8000-10000 rpm to obtain sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion C. (2) Add 11.5 g of sea salt to 200 mL of water and stir until completely dissolved to obtain solution D. (3) adding the composite dispersion C to the solution D, stirring at room temperature, then adding a pH adjuster, citric acid, to adjust the pH value to 6.0, and continuing stirring to obtain a uniformly dispersed liquid, thereby obtaining the seawater nasal cleaning dressing; (4) Fill into a spray bottle and sterilize by 25kGy Co60 irradiation before use with the spray bottle.

[0023] Comparative Example 1 (1) Add 4.5 g of sea salt, 0.5 g of sodium carboxymethyl cellulose (labeled viscosity 800 mPa·s), and 0.5 g of lithium magnesium silicate (Laponite XLG-XR) to 500 mL of water and stir at 40-80°C. (2) adding citric acid to adjust the pH value to a weakly acidic pH of 6.0, and stirring at room temperature until completely dissolved, thereby obtaining the seawater nasal cleaning dressing; (3) Fill into a spray bottle and sterilize by 25kGy Co60 irradiation before use with the spray bottle.

[0024] Comparative Example 2 A method for preparing a seawater nasal cleaning dressing is as follows: (1) Add 4.5 g of sea salt to 500 mL of water and stir until completely dissolved to obtain sea salt water; (2) Add 0.5 g of sodium carboxymethyl cellulose (labeled viscosity 800 mPa·s) to sea salt water and stir at 80°C; (3) Add 0.5 g of lithium magnesium silicate (Laponite XLG-XR) to the solution in (2) and stir at 80°C; (4) adding citric acid to adjust the pH value to a weakly acidic pH of 5.5, and stirring at room temperature until the mixture is fully dissolved, thereby obtaining the seawater nasal cleaning dressing; (5) Fill into a spray bottle and sterilize by 25kGy Co60 irradiation before use with the spray bottle.

[0025] Viscosity test The seawater nasal cleaning dressings in the embodiment and the comparative example were respectively subjected to viscosity tests, and the test was performed according to the rotational viscometer method in the general rule 0633 viscosity determination method of the Pharmacopoeia 2020 Edition Part IV, and the test steps were as follows: The seawater nasal cleaning dressings of the examples and comparative examples were shaken up and down for 1-5 minutes. After being fully shaken, 20 mL was taken into a container and tested using a rotational viscometer. Three parallel samples were measured in each group.

[0026] Table 1 Viscosity test results sample Viscosity Example 1 18.49 mPa·s Example 2 30.40 mPa·s Example 3 51.81 mPa·s Comparative Example 1 22.11 mPa·s Comparative Example 2 21.9 1mPa·s From the viscosity test results, it can be seen that the viscosity of the comparative example is less than that of Example 2. The difference is that in Example 2, the "sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion" is first prepared and then added to the sea salt solution. In the sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion solution, the charges of sodium carboxymethyl cellulose and lithium magnesium silicate interact with each other, so that the two are further fully dissolved in the system and stably combined. In Examples 1-3, the viscosity increases with the increase of the feed amount.

[0027] Appearance stability test The seawater nasal cleaning dressings in the examples and comparative examples were tested for appearance stability, and the test steps were as follows: Use a measuring cylinder to take 50 mL of the freshly prepared test sample and place it in a transparent container. Store it in a 4°C refrigerator, room temperature (23-25°C), or a 37°C constant temperature box for 24 hours for stability testing. Observe whether the seawater nasal cleaning dressing has stratification and precipitation at low temperature, room temperature, or above room temperature. If the above phenomenon occurs, it is recorded as a non-uniform liquid.

[0028] Table 3 Appearance stability test results temperature 4℃ Room temperature 37℃ Example 1 Homogenous liquid Homogenous liquid Homogenous liquid Example 2 Homogenous liquid Homogenous liquid Homogenous liquid Example 3 Homogenous liquid Homogenous liquid Homogenous liquid Comparative Example 1 Inhomogeneous liquid Inhomogeneous liquid Inhomogeneous liquid Comparative Example 2 Inhomogeneous liquid Inhomogeneous liquid Inhomogeneous liquid From the stability test results, it can be seen that when the seawater nasal cleaning dressing is stored at 4°C, room temperature, and 37°C for 24 hours, the appearance of Examples 1-3 is stable and maintains a uniform liquid state, while the comparative example will have stratification and precipitation. This result confirms the benefits of the preparation method of the present invention, and the uniform liquid form is conducive to the application of the seawater nasal cleaning dressing.

[0029] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A seawater nasal cleaning dressing, characterized in that: The ingredients include sea salt water and a composite dispersion, wherein the composite dispersion contains: lithium magnesium silicate with a high specific surface area (>350 m² / g) and sodium carboxymethyl cellulose with a specific viscosity (600-5600 mPa·s); the composite dispersion is a stable colloidal solution formed by electrostatic action, which is used to enhance the adhesion of the dressing, increase the retention time of the dressing in the nasal cavity, and has good adsorption and biocompatibility.

2. A method for preparing the seawater nasal cleaning dressing according to claim 1, characterized in that The following steps are involved: (1) Preparing a composite dispersion: adding sodium carboxymethyl cellulose to water and stirring until completely dissolved to obtain solution A; adding lithium magnesium silicate to water and stirring at 40-80° C., cooling to room temperature to obtain solution B; adding solution B to solution A and stirring at high speed to obtain a sodium carboxymethyl cellulose-lithium magnesium silicate composite dispersion C; (2) Preparation of sea salt solution: Add sea salt to water and stir until completely dissolved to obtain solution D; (3) Mixing and adjusting pH: Add the composite dispersion C to solution D, stir evenly, then add a pH adjuster to adjust the pH value to weak acidity, and keep stirring to obtain a uniform dispersion; (4) Filling and sterilization: The uniform dispersion obtained is filled into a container and sterilized to obtain the seawater nasal cleaning dressing.

3. The preparation method according to claim 2, characterized in that: In the step (1), the ratio of sodium carboxymethyl cellulose to lithium magnesium silicate is 1:1-2.

4. The preparation method according to claim 2, characterized in that: The high-speed stirring speed in step (1) is 8000-12000 rpm.

5. The preparation method according to claim 2, characterized in that: The amount of sea salt in step (2) is calculated based on a final concentration of 0.9-2.3%.

6. The preparation method according to claim 2, characterized in that: The pH adjuster used in step (3) is at least one of hydrochloric acid, phosphoric acid, citric acid, malic acid, gluconic acid and lactic acid.

7. The preparation method according to claim 2, characterized in that: In the step (3), the pH value is adjusted to 3.0-6.

5.

8. The preparation method according to claim 2, characterized in that: The sterilization method of step (4) is Co 60 Radiation sterilization, sterilization dose is 15~25kGy.