A functional liquid dressing for hemostasis and promotion of nasal mucosa repair and a preparation process

Abstract

The present application relates to a kind of medical dressings, specifically to a kind of functional liquid dressing for hemostasis and promote nasal mucosa repair and preparation process, the functional dressing is prepared by the following components by mass percentage: potassium alginate 0.8-0.9%, hydroxypropyl methyl cellulose 1.5-1.8%, polycarboxyl methyl aminopolysaccharide 0.3-0.4%, the rest is physiological saline with 0.9% sodium chloride content.The functional dressing of the present application is suitable for postoperative bleeding of nasal cavity, nasal mucosa damage bleeding and promote nasal mucosa erosion and other wound surface hemostasis, repair, antibacterial and protection, and degradation is complete, can be absorbed by body, no toxic side effects to body, safe to use.

Description

TECHNICAL FIELD

[0001] The present application relates to a medical dressing, in particular to a functional liquid dressing for hemostasis and promoting the repair of nasal mucosa. BACKGROUND

[0002] With the change of external air quality and climate, the number of patients with nasal bleeding and damaged nasal mucosa is increasing. There are many causes of nasal bleeding and damaged nasal mucosa, and the more common ones are:

[0003] 1. Nasal dryness: If you are in a dry environment for a long time, it may cause damage to the nasal mucosa, and you can use compound peppermint oil nasal drops according to the doctor's advice;

[0004] 2. Deviated nasal septum: Patients with deviated nasal septum may also have symptoms of damaged nasal mucosa due to weak nasal mucosa, and can use oxymetazoline hydrochloride nasal spray under the guidance of a doctor to relieve symptoms. If conservative treatment is ineffective, a deviated nasal septum correction surgery can be performed;

[0005] 3. Rhinitis: caused by infection, allergy and other reasons, patients with rhinitis may also have damaged nasal mucosa under the stimulation of inflammation, and can use physiological seawater to rinse the nasal cavity, and use mometasone furoate nasal spray, fluticasone propionate nasal spray, etc. At the same time, you can take rhinitis tablets, amoxicillin capsules and other drugs for treatment;

[0006] 4. Sinusitis: sinusitis is often secondary to rhinitis, and patients may also have damaged nasal mucosa under the stimulation of inflammation. You can take clarithromycin sustained-release tablets, biyan shu oral liquid and other drugs for treatment. Patients with nasal dryness can use compound peppermint oil nasal drops for treatment;

[0007] 5. Others: damage to the nose, nasal trauma and other reasons can also cause damage to the nasal mucosa.

[0008] At present, antibiotics, hormone drugs and nasal irrigation methods are often used to solve the problem, but the effect is not very ideal. SUMMARY

[0009] To solve the above problems, the present application provides a functional dressing suitable for postoperative bleeding, damaged nasal mucosa, and promoting the repair of nasal mucosa and other wound surfaces, hemostasis, repair, antibacterial and protection.

[0010] To achieve the above purpose, the technical scheme adopted by the present application is:

[0011] A functional liquid dressing for hemostasis and promoting the repair of nasal mucosa, prepared from the following components by mass percentage:

[0012] Potassium alginate 0.8-0.9%, hydroxypropyl methyl cellulose 1.5-1.8%, polycarboxymethyl amino polysaccharide 0.3-0.4%, the rest is physiological saline with sodium chloride content of 0.9%.

[0013] The application also provides a preparation method of the functional liquid dressing for hemostasis and promoting repair of nasal mucosa, comprising the following steps:

[0014] S1, under sterile conditions, taking 800g of physiological saline heated to 70-80℃, slowly adding 15-20g of hydroxypropyl methyl cellulose and 8-10g of potassium alginate, and fully stirring uniformly by a high-speed dispersion machine, so that the hydroxypropyl methyl cellulose and the potassium alginate are fully dissolved, and then cooling to room temperature for standby;

[0015] S2, taking 3-5g of polycarboxymethyl amino polysaccharide dissolved in 100g of physiological saline at 80℃ to obtain a polycarboxymethyl amino polysaccharide solution;

[0016] S3, mixing the mixed solution and the polycarboxymethyl amino polysaccharide solution, adding physiological saline to make up to 1000g, stirring uniformly, filtering through 40-mesh filter cloth, adjusting the pH value to 4.5-6.5 by hydrochloric acid or glacial acetic acid, and packaging, sterilizing and warehousing.

[0017] Further, in the step S3, the stirring speed should not be greater than 900rpm, and the stirring temperature should be below 80℃.

[0018] The functional dressing of the application is suitable for postoperative bleeding of the nasal cavity, damaged nasal mucosa bleeding and promoting hemostasis, repair, antibiosis and protection of the wound surface of nasal mucosa erosion, and can be completely degraded and absorbed by the body, has no toxic and side effects on the body, and is safe to use. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 ROS levels bar graph (x±s, n=5). DETAILED DESCRIPTION

[0020] The application will be described in detail below with specific examples. The following examples will help those skilled in the art to further understand the application, but do not limit the application in any form. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the application. These all belong to the protection scope of the application.

[0021] Example 1

[0022] S1, under sterile conditions, take 800g of physiological saline heated to 70℃, slowly add 15g of hydroxypropyl methyl cellulose and 8g of potassium alginate, fully stirred by high-speed dispersion machine to make hydroxypropyl methyl cellulose and potassium alginate fully dissolved, then get a mixed solution, and cool to room temperature for standby;

[0023] S2, take 3g of polycarboxymethyl aminopolysaccharide (carboxymethyl aminopolysaccharide) and dissolve in 100g of physiological saline at 80℃ to get a polycarboxymethyl aminopolysaccharide solution;

[0024] S3, after mixing the mixed solution and the polycarboxymethyl aminopolysaccharide solution, add physiological saline to make up to 1000g, stir evenly, the stirring speed should not be greater than 900rpm, the stirring temperature should be below 80℃, the stirring time should be controlled within 45min, filter with 40 mesh filter cloth, adjust the pH value to 4.5 with hydrochloric acid or glacial acetic acid, package, sterilize and store in warehouse.

[0025] Example 2

[0026] S1, under sterile conditions, take 800g of physiological saline heated to 80℃, slowly add 20g of hydroxypropyl methyl cellulose and 10g of potassium alginate, fully stirred by high-speed dispersion machine to make hydroxypropyl methyl cellulose and potassium alginate fully dissolved, then get a mixed solution, and cool to room temperature for standby;

[0027] S2, take 5g of polycarboxymethyl aminopolysaccharide (carboxymethyl aminopolysaccharide) and dissolve in 100g of physiological saline at 80℃ to get a polycarboxymethyl aminopolysaccharide solution;

[0028] S3, after mixing the mixed solution and the polycarboxymethyl aminopolysaccharide solution, add physiological saline to make up to 1000g, stir evenly, the stirring speed should not be greater than 900rpm, the stirring temperature should be below 80℃, the stirring time should be controlled within 65min, filter with 40 mesh filter cloth, adjust the pH value to 6.5 with hydrochloric acid or glacial acetic acid, package, sterilize and store in warehouse.

[0029] Example 3

[0030] S1, under sterile conditions, take 800g of physiological saline heated to 75℃, slowly add 17.5g of hydroxypropyl methyl cellulose and 9g of potassium alginate, fully stirred by high-speed dispersion machine to make hydroxypropyl methyl cellulose and potassium alginate fully dissolved, then get a mixed solution, and cool to room temperature for standby;

[0031] S2, take 4g of polycarboxymethyl aminopolysaccharide (carboxymethyl aminopolysaccharide) and dissolve in 100g of physiological saline at 80℃ to get a polycarboxymethyl aminopolysaccharide solution;

[0032] S3, after mixing the mixed solution and the polycarboxymethyl aminopolysaccharide solution, physiological saline is added to make up to 1000g, and the mixture is stirred uniformly, the stirring speed should not be greater than 900rpm, the stirring temperature is below 80℃, the stirring time is controlled within 55min, 40 mesh filter cloth is used for filtration, hydrochloric acid or glacial acetic acid is used to adjust the pH value to 5.5, and then the mixture is packaged, sterilized and stored in warehouse.

[0033] Comparative Example 1

[0034] The hydroxypropyl methyl cellulose in Example 1 is replaced with an equal amount of potassium alginate.

[0035] Comparative Example 2

[0036] The polycarboxymethyl aminopolysaccharide (carboxymethyl aminopolysaccharide) in Example 2 is replaced with an equal amount of hydroxypropyl methyl cellulose.

[0037] Comparative Example 3

[0038] The potassium alginate in Example 3 is replaced with an equal amount of hydroxypropyl methyl cellulose.

[0039] Test data:

[0040] 80 SPF level 6-7 week old SD male rats weighing 160-190g are selected, and after 3 days of adaptive adaptation, an AR model of the rats is established by inducing with ovalbumin (OVA), the modeling method is as follows: on the 1st, 5th, 14th and 21st days, the mice are given intraperitoneal injection of a suspension containing OVA 25μg, aluminum hydroxide gel [Al(OH)3] 1mg and isotonic saline 0.5ml to perform basic sensitization, and after the basic sensitization, on the 28th day, the mice are given bilateral intranasal instillation of 500μg OVA plus 20μl isotonic saline, which is continuously performed for 10 days.

[0041] The successfully modeled rats are randomly divided into a model group, a test group 1 (50μg per side, twice a day), a test group 2 (50μg per side, twice a day), a test group 3 (50μg per side, twice a day), a control group 1 (50μg per side, twice a day), a control group 2 (50μg per side, twice a day), a control group 3 (50μg per side, twice a day) and a blank group, 10 rats in each group. The rats in each drug group are given the corresponding drug, and the rats in the blank group and the model group are given an equal amount of normal saline, which is continuously performed for 4 weeks.

[0042] 4 hours after the end of the last administration, 5 rats are randomly selected from each group for anesthesia, and after being sacrificed, the nasal mucosa is taken and fixed in 40ng / L paraformaldehyde for 48 hours, dehydrated, embedded in paraffin and sliced (thickness 3μm), HE staining is performed, and the pathological changes of the nasal mucosa are observed under a light microscope, 10 200x fields are selected to observe the pathological conditions of the mucosal epithelial layer, lamina propria, basement membrane and submucosal layer, and the results are quantified according to the standard in Table 1, and the results are shown in Table 2.

[0043] Table 1 Rat nasal mucosa pathological quantitative score standard

[0044]

[0045]

[0046] Table 2 Nasal mucosa pathological score of each group

[0047]

[0048] Results show that the nasal mucosa tissue structure of the model group rats is disordered, the blood vessels of the lamina propria are dilated, the epithelium is shed and hyperplasia in a large area, and a large number of inflammatory cells infiltrate; after 4 weeks of intervention of each test group drug, the epithelium of the nasal mucosa tissue of the rats is arranged in order, the blood vessels of the lamina propria are not significantly dilated, the epithelial layer structure is restored and the inflammatory cell infiltration is significantly reduced, and the nasal mucosa pathological score is significantly lower than that of the model group; at the same time, after 4 weeks of intervention of each control group drug, the epithelium of the nasal mucosa tissue of the rats is arranged in order, the blood vessels of the lamina propria are dilated, the epithelial layer is generally restored, and the inflammatory cell infiltration is slightly reduced than the model group, and the nasal mucosa pathological score of each test group is significantly lower than that of each control group, and the reason may be that there is a synergistic relationship among potassium alginate, hydroxypropyl methyl cellulose and polycarboxymethyl amino polysaccharide.

[0049] Take the nasal mucosa tissue of 5 rats in each group above, cut into small pieces with an area of about 1mm 2 , wash with phosphate buffer solution, add collagenase 1mL, incubate at 37℃ for 10min (shake every 5min); after the tissue is completely dissociated, stop digestion with 3% fetal bovine serum, and filter with a 70μm filter screen; add phosphate buffer solution 10mL to the cells, centrifuge. Remove the supernatant; add DCFH-DA working solution (prepared with serum-free RPMI-1640 culture medium, final concentration 10μmol / L) 500μL to the cells, incubate at 37℃ for 20min, wash with serum-free RPMI-1640 culture medium 3 times, resuspend with phosphate buffer solution, and detect the fluorescence intensity with a flow cytometer to represent the ROS level (in direct proportion).

[0050] Results: As Figure 1Compared with the blank group, the ROS level in the nasal mucosa tissue of the model group was significantly increased (P<0.05), indicating that the injury and inflammation of the nasal mucosa tissue of the rat can be related to the increase of the ROS level; compared with the model group, the ROS level in the nasal mucosa tissue of each test group and the control group was significantly decreased (P<0.05), and the ROS level in the nasal mucosa tissue of each test group was significantly lower than that in the nasal mucosa tissue of the control group (P<0.05), indicating that the improvement of the nasal mucosa tissue injury and inflammation of the rat in each test group and the control group can be related to the decrease of the ROS level, and there is a synergistic relationship among potassium alginate, hydroxypropyl methyl cellulose and polycarboxymethyl amino polysaccharide.

[0051] In summary, the functional dressing of the present application is mainly used for treating the inflammation of the nasal cavity caused by the bleeding, bleeding or injury of the nasal mucosa, and the components can effectively relieve the discomfort of the nose and promote wound healing, repair and nourish the nasal mucosa, and have the function of cleaning and washing the nasal cavity, so that the nasal cavity can restore the ideal physiological function.

[0052] In the use of the embodiment, the spray is directly sprayed on the bleeding point of the nasal cavity, the postoperative or injured surface and the inflamed nasal mucosa in the form of spray, and is sprayed once every 3-4 hours according to the degradation time, and 3-4 sprays are sprayed in each nostril each time.

[0053] The specific embodiments of the present application are described above. It should be understood that the present application is not limited to the above specific embodiments, and various modifications or changes can be made by those skilled in the art within the scope of the claims, which does not affect the essential content of the present application.

Claims

1. A method of preparing a functional liquid dressing for hemostasis and promotion of nasal mucosa repair, characterized by: It comprises the following steps: S1. Under sterile conditions, 800g of normal saline is heated to 70-80℃, 15-20g of hydroxypropyl methyl cellulose and 8-10g of potassium alginate are slowly added, and the mixture is fully stirred by a high-speed dispersion machine until the hydroxypropyl methyl cellulose and potassium alginate are fully dissolved to obtain a mixed solution, which is cooled to room temperature for standby; S2. 3-5g of polycarboxymethyl aminopolysaccharide is dissolved in 100g of normal saline at 80℃ to obtain a polycarboxymethyl aminopolysaccharide solution; S3. The mixed solution and the polycarboxymethyl aminopolysaccharide solution are mixed, 1000g of normal saline is added, and the mixture is stirred uniformly and filtered through a 40-mesh filter cloth. The pH value is adjusted to 4.5-6.5 with hydrochloric acid or glacial acetic acid, and the mixture is packaged, sterilized and stored in a warehouse.

2. The production method according to claim 1, characterized by: In the step S3, the stirring speed should not be greater than 900rpm, and the stirring temperature should be below 80℃.

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