A topical application type high osmotic gel and a preparation method thereof

Abstract

The application discloses a body surface smearing type hypertonic gel as well as a preparation method and application thereof, and belongs to the technical field of medical wound dressings. The hypertonic gel is a homogeneous gel with an osmotic pressure of 600mOsm / L-1200mOsm / L and is composed of a core base material and a functional component; the core base material is a gel matrix, and the functional component is a metal salt. The hypertonic gel of the application forms a pressure difference with the osmotic pressure of the human body, so that the swelling liquid between body tissues is permeated to the outside of the body and is absorbed by the gel, and then a significant de-swelling effect on the swelling of the body surface soft tissue is achieved. The hypertonic gel of the application is stable in structure, and has a high clinical application value and industrialization value.

Description

Technical Field

[0001] This invention belongs to the field of medical wound dressing technology, specifically relating to a topical hypertonic gel and its preparation method. Background Technology

[0002] Soft tissue edema is a common problem in acute soft tissue trauma, postoperative surgical wounds, and soft tissue injuries to athletes.

[0003] Currently, the mainstream anti-swelling dressing in clinical practice is hypertonic sodium chloride dressing, which has inherent defects such as instantaneous hypertonicity, strong impact, obvious burning pain on the wound surface, easy damage to the rapid dehydration of newly formed granulation tissue, and short effective time (for example, the effective time of the Mononic-produced Meisa wound dressing is less than 1 hour), resulting in poor patient compliance.

[0004] Existing commercial wound dressings primarily use sodium carboxymethyl cellulose, low-crosslinked chitosan, or a single PVA system as their base material. Sodium carboxymethyl cellulose is a plant-based inert polymer with no natural antibacterial properties or wound-healing bioactivity; it only possesses basic water absorption and moisturizing functions and cannot stably release high osmotic pressure. Low-crosslinked (20%–25%) carboxymethyl chitosan has a loose molecular network structure and weak ion-locking capacity, making it prone to instantaneous release of magnesium ions. This not only poses a risk of local wound irritation but also results in poor long-term storage stability of the effective osmotic pressure, failing to simultaneously meet the core requirements of efficient swelling reduction, long-lasting effect, and safe use. PVA focuses only on film-forming protection, creating a moist healing environment, but lacks antibacterial and high-osmotic functions.

[0005] In summary, existing technologies for reducing soft tissue swelling after injury generally suffer from the following core technical shortcomings: First, the osmotic pressure parameters are not properly matched, with hypertonic systems irritating the wound and hypotonic systems being ineffective in reducing swelling; second, high-osmotic pressure compatibility systems have poor stability and are prone to crystallization and stratification during long-term storage; third, osmotic pressure release is uncontrollable, resulting in short-term effects and preventing long-term intervention; and fourth, some high-osmotic pressure dressings pose a risk of ion accumulation in the bloodstream, limiting their safety. Currently, there is no multifunctional innovative hypertonic gel that can simultaneously meet the requirements of hypertonic swelling reduction, long-lasting sustained release, low irritation, storage stability, suitability for sports scenarios, and no risk of systemic absorption. Summary of the Invention

[0006] To address the numerous shortcomings of existing technologies, this invention provides a topical hypertonic gel, its preparation method, and its application. By crosslinking the core substrate with functional components to form a homogeneous gel with an osmotic pressure of 600 mOsm / L to 1200 mOsm / L, this invention solves the problems of poor anti-swelling effect, short duration of action, poor stability, and high irritation associated with existing hypertonic gels.

[0007] In a first aspect, the present invention provides a surface-applied hypertonic gel, which is a homogeneous gel with an osmotic pressure of 600 mOsm / L to 1200 mOsm / L composed of a core substrate and functional components; wherein the core substrate is a gel matrix and the functional components are metal salts.

[0008] Furthermore, the gel matrix is ​​selected from any one of carboxymethyl chitosan, sodium carboxymethyl cellulose, and alginate.

[0009] Furthermore, the aforementioned metal salt is selected from any one of magnesium salts, iron salts, and aluminum salts.

[0010] It should be noted that the aforementioned metal salts include, but are not limited to, the magnesium salts, iron salts, and aluminum salts mentioned above. Other metal salts that are harmless to the human body can also be used, such as zinc salts, manganese salts, potassium salts, and sodium salts.

[0011] Preferably, the gel matrix is ​​carboxymethyl chitosan; and the metal salt is magnesium sulfate.

[0012] Furthermore, the components, by mass percentage, are: carboxymethyl chitosan 4wt%–12wt%, magnesium sulfate 6wt%–18wt%, and the remainder is purified water.

[0013] In a second aspect, the present invention provides a method for preparing the hypertonic gel provided in the first aspect above, comprising the following steps: S1. Substrate swelling: Under normal temperature conditions, the carboxymethyl chitosan powder is uniformly dispersed in purified water until the powder is completely swollen and the system is uniform and transparent to obtain the CMCS matrix; S2. Preparation of magnesium sulfate solution: Add the magnesium sulfate to pure water, vortex until the magnesium sulfate is completely dissolved, and let stand at room temperature; S3. Gel preparation: Add the magnesium sulfate solution and pure water to the above CMCS matrix and stir until the magnesium sulfate solution is fully dispersed in the CMCS matrix. The carboxymethyl chitosan crosslinks with magnesium ions to form a stable three-dimensional network structure, thus obtaining a stable gel.

[0014] Furthermore, in S1 above, at room temperature, pure water is first placed in a stirrer and stirred, then carboxymethyl chitosan powder is added in batches, and after stirring continuously for 1 to 3 hours, degassing is performed.

[0015] Furthermore, in S2, the vortex oscillation processing time is 1 min to 2 min.

[0016] Furthermore, in S3, the stirring time is 1h to 3h.

[0017] Thirdly, the present invention also provides the application of the hypertonic gel as provided in the first aspect above or the hypertonic gel prepared by the preparation method provided in the second aspect above, applying it to reduce swelling of soft tissues on the body surface.

[0018] For example, it has a significant swelling-reducing effect on soft tissue edema caused by acute soft tissue trauma, postoperative surgical wounds, and soft tissue injuries to athletes.

[0019] Beneficial effects Compared with the prior art, the beneficial effects of the present invention are reflected in the following aspects: First, the overall osmotic pressure of the hypertonic gel of the present invention is stably controlled at 600mOsm / L to 1200mOsm / L, which avoids the strong irritation to the wound surface caused by existing dressings, improves comfort, and greatly enhances patient compliance with the product.

[0020] Secondly, this invention preferably selects carboxymethyl chitosan as the optimal gel matrix, which has a stable structure. This solves the defects of existing gel structures such as loose structure, ion leakage, crystallization and stratification, and poor stability.

[0021] Third, the hypertonic gel of the present invention is not only suitable for acute postoperative wounds and acute traumatic wounds, but also fills the gap in the special gel for reducing swelling of soft tissue injuries on the body surface of athletes. The gel of the present invention has strong toughness and can be adapted to competitive sports such as football and basketball. It is suitable for high-intensity sports with high sweating and high activity levels, and specifically solves the pain point of difficult care after sports injuries. Its adaptability to different scenarios is far superior to traditional dressings. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the three-dimensional network-sustained release effect structure of the hypertonic gel of the present invention.

[0023] Figure 2 For Experimental Example 1 of this invention, the CMCS-Mg² values ​​at various osmotic pressures are... + Photo of the gel product.

[0024] Figure 3 For Experimental Example 1 of this invention, the CMCS-Mg² values ​​at various osmotic pressures are... + Results of flowability testing for gel products.

[0025] Figure 4 For Experimental Example 1 of this invention, the CMCS-Mg² values ​​at various osmotic pressures are... + Results of the extensibility test for the gel product.

[0026] Figure 5 These are photographs of the right hind limbs of nude mice at different time points in Experiment Example 2 of this invention.

[0027] Figure 6 This is the HE staining result from Experimental Example 3 of this invention.

[0028] Figure 7This is the Masson staining result from Experiment Example 3 of this invention.

[0029] Figure 8 The osmotic pressure-time curve is shown in Experiment Example 3 of the invention.

[0030] Figure 9 This is a fluorescence imaging image of DAPI in Experimental Example 3 of the invention. Detailed Implementation

[0031] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] Example 1: A hypertonic gel was prepared using carboxymethyl chitosan as the gel matrix and magnesium sulfate as the metal salt. The specific steps are as follows: S1. Preparation of 8wt% CMCS matrix Weigh out CMCS (batch number: SJKT-251102) powder. Based on the mass of CMCS, CMCS-Mg... 2+ Based on a total gel preparation mass of 8wt%, weigh 0.24g of CMCS. Using a clean 10mL vial as the preparation container, accurately measure 1.8mL (60% of total weight) of pure water using a single-channel manual pipette with a maximum capacity of 1mL. Place the water in the center of the magnetic stir bar and turn on the stirrer. Adjust the stirrer knob to approximately 70% of its maximum scale (about 2 / 3 of the total stroke) to ensure stable high-speed rotation without jumping. While continuously stirring, evenly sprinkle the accurately weighed CMCS powder into the center of the liquid surface in small, repeated additions. Wait until each addition is completely wetted and incorporated into the liquid surface before adding the next. Repeat this process until all CMCS powder has been added. Throughout the process, avoid adding large amounts at once, as this can cause the powder surface to rapidly absorb water and clump together into insoluble matter. After the addition of materials is complete, maintain the above-mentioned stirring speed and continue stirring for 2 hours. During this period, every 30 minutes, use a stainless steel scraper to scrape the CMCS flocs that are not yet fully dispersed and adhere to the bottle wall and around the stir bar into the liquid matrix to promote its full hydration and dispersion. After stirring, seal the vial and let it stand at room temperature (20℃~25℃) for 2 hours until all the air bubbles in the solution have escaped, finally obtaining a completely clear and transparent CMCS matrix for later use.

[0033] S2. Preparation of magnesium sulfate solution: Accurately weigh 0.37 g of MgSO4·7H2O solid (batch number: A2425183) into a 5 mL centrifuge tube. Using a single-channel manual pipette with a maximum capacity of 1 mL, add 60% of the working solution volume (1.8 mL) of pure water to the tube. Tightly cap the tube and vortex for 2 minutes to allow the solid to initially dissolve. If undissolved particles remain, allow the solution to stand at room temperature (20℃~25°C) and vortex repeatedly until the solution is completely clear and transparent with no visible insoluble matter at the bottom. After complete dissolution, add pure water to a final volume of 0.75 mL. A 0.4929 g / mL MgSO4 solution is obtained. After preparation, label the tube with the theoretical osmotic pressure and preparation date, seal and store for later use.

[0034] S3. Gel preparation: Using a single-channel manual pipette with a maximum capacity of 1 mL, accurately measure 0.75 mL of the MgSO4 solution prepared in step S2 and 0.21 mL of pure water, and add them to the CMCS matrix (2.04 g) prepared in step S1. After addition, place each vial in the center of a magnetic stirrer, turn on the stirrer, and adjust the magnetic stirrer knob to approximately 70% of the maximum scale (approximately 2 / 3 of the total stroke) to ensure stable high-speed rotation without jumping. Continue stirring at this speed at room temperature (20℃~25℃) for 2 hours to ensure the MgSO4 solution is fully and uniformly dispersed in the CMCS matrix, while simultaneously promoting the ionic cross-linking reaction between magnesium ions and the carboxyl groups on the CMCS molecular chains, forming a three-dimensional network structure of magnesium ion-crosslinked carboxymethyl chitosan gel. In the hypertonic gel product prepared in this example, the mass percentage of magnesium sulfate is 14.1 wt%. During stirring, carefully observe the state of the gel in each bottle. If gel adheres to the bottle walls or around the stir bar, scrape it back into the gel mass every 30 minutes using a stainless steel spatula to ensure uniform mixing. After preparation, seal and store, allowing to stand to defoam.

[0035] Example 2: The difference from Example 1 is that the mass percentage of CMCS in the hypertonic gel product prepared in this example is 4 wt%.

[0036] Example 3: The difference from Example 1 is that the mass percentage of CMCS in the hypertonic gel product prepared in this example is 12 wt%.

[0037] Example 4: The difference from Example 1 is that the mass percentage of magnesium sulfate in the hypertonic gel product prepared in this example is 6 wt%.

[0038] Example 5: The difference from Example 1 is that the mass percentage of magnesium sulfate in the hypertonic gel product prepared in this example is 18 wt%.

[0039] Example 6: The difference from Example 1 is that in S1, the stirring time is 1 hour.

[0040] Example 7: The difference from Example 1 is that in S1, the stirring time is 3 hours.

[0041] Example 8: The difference from Example 1 is that in S2, the vortex oscillation processing time is 1 minute.

[0042] Example 9: The difference from Example 1 is that in S2, the vortex oscillation processing time is 1.5 min.

[0043] Example 10: The difference from Example 1 is that in S3, the stirring time is 1 hour.

[0044] Example 11: The difference from Example 1 is that in S3, the stirring time is 3 hours.

[0045] Example 12: The difference from Example 1 is that the gel matrix used in this example is sodium carboxymethyl cellulose.

[0046] Example 13: The difference from Example 1 is that the gel matrix used in this example is sodium alginate.

[0047] Example 14: The difference from Example 12 is that the metal salt used in this example is an iron salt.

[0048] Example 15: The difference from Example 13 is that the metal salt used in this example is an aluminum salt.

[0049] Example 16: The difference from Example 13 is that the metal salt used in this example is a potassium salt.

[0050] To verify the feasibility of the formulation design and stability of the hypertonic gel product of the present invention, the anti-swelling effect of hypertonic gels with different osmotic pressures and the safety of the product, we further investigated the hypertonic gel product of the present invention in conjunction with the following experimental examples 1 to 3.

[0051] Experimental Example 1: Preparation and property characterization of hyperosmotic gel products with different osmotic pressure gradients.

[0052] Following the method described in Example 1 above, a series of magnesium ion-crosslinked carboxymethyl chitosan hyperosmotic gels (hereinafter referred to as CMCS-Mg) with theoretical osmotic pressures of 400, 600, 800, 1000, and 1200 mOsm / L were prepared. 2+ The gel was tested, and its actual osmotic pressure at 24h and 48h was measured to verify the feasibility and stability of the formulation design. The specific formulation preparation is shown in Table 1.

[0053] Table 1: CMCS-Mg² at various osmotic pressures + Gel Formula (1) Observation of gel properties Each CMCS-Mg² prepared according to the above formula + The gels were examined for their appearance (see...). Figure 2 ), liquidity testing (see Figure 3 ) and ductility testing (see Figure 4 The results showed that all gels were clear and transparent in appearance, had a uniform texture, showed almost no flow when inverted, and exhibited good spreadability, making them suitable for topical application to the skin.

[0054] (2) Gel osmotic pressure detection For each of the above CMCS-Mg² + After the gel and blank CMCS gel were allowed to stand for 24 h and 48 h respectively, their osmotic pressure was measured. The results are shown in Table 2 and Table 3.

[0055] Table 2: 24h CMCS-Mg² + Gel osmotic pressure Table 3: CMCS-Mg² for 48h + Gel osmotic pressure As can be seen from the data in Tables 2 and 3, the deviation between the measured osmotic pressure and the theoretical value of each gel formulation is ≤35mOsm / L, and the deviation (RSD) from the standard value is ≤5%.

[0056] The results show that the formulation and preparation process of the present invention are reasonably designed, and the prepared hyperosmotic gel product has a stable osmotic pressure gradient and good deviation control, which can effectively control the target osmotic pressure.

[0057] Experimental Example 2: Investigation into the anti-swelling effect of hypertonic gel products.

[0058] (1) Establishment of the swelling model: Forty BALB / c nude mice were randomly divided into eight groups of five each: model control group, positive control group, blank CMCS gel experimental group, and 400 mOsm / LCMCS-Mg² group. + Gel experimental group, 600mOsm / L CMCS-Mg² + Gel experimental group, 800mOsm / LCMCS-Mg² + Gel experimental group, 1000mOsm / LCMCS-Mg² + Gel experimental group, 1200 mOsm / LCMCS-Mg²+ Gel experimental group.

[0059] For each group of mice, 0.15 mL of 0.9% sodium chloride injection solution was slowly injected subcutaneously using a 1 mL sterile syringe. The injection process was uniform and slow to avoid leakage, subcutaneous bleeding, and tissue traction damage. After injection, the local tissue morphology was observed. The model was considered successful if there was obvious swelling at the injection site and no extravasation of the injection solution or subcutaneous hematoma was observed. After successful modeling, the weight of each nude mouse was measured, and the width and thickness of the corresponding marked site on the right hind limb thigh of each nude mouse were measured. Morphological images of the right hind limb of each group of nude mice were also collected.

[0060] (2) Apply saline dressing or apply gel: ① After successful modeling and completion of swelling size measurement, weight measurement and image acquisition, each group of nude mice was initially treated with saline dressing or gel.

[0061] The model control group received only a waterproof bandage covering the swollen area of ​​the right hind limb thigh; the positive control group received Mesalt hypertonic dressing; each experimental group received blank CMCS gel and 400, 600, 800, 1000, and 1200 mOsm / LCMCS-Mg²2 solutions respectively using a 1 mL syringe. + Apply 0.2 mL (0.22 g) of gel evenly to cover the swollen area, covering an area of ​​approximately 1 cm², with a gel thickness of approximately 0.2 cm. All dressings or gel layers are wrapped with waterproof bandages and secured with medical tape, applying gentle and even pressure to avoid compressing the limb and affecting local blood circulation.

[0062] ② Treatment with application of saline dressing or gel for 12 hours: After applying saline dressing or gel for 12 hours, gently remove the original waterproof bandages from each group. Weigh the nude mice in each group, and then use digital calipers to measure the width and thickness of the swollen area in the right hind leg thigh of each group of nude mice. At the same time, take photos at the 12-hour time point for record-keeping.

[0063] Replace with a brand new dressing or gel of the same group as described above for the initial application of the saline dressing or gel, re-fix it, and continue to apply the saline dressing or gel for 24 hours.

[0064] ③ Apply saline dressing or gel for 24 hours: Remove all drained wound dressings from all groups, weigh the nude mice in each group, and follow the steps in ② above to measure the width and thickness of the swollen area on the right hind limb of each group of nude mice and take photos of the right hind limb of each group of nude mice.

[0065] (3) Calculation of swelling reduction rate: We collected and summarized the body weight, width (w), and thickness (h) of the right hind limb thigh of all nude mice before modeling, at 0h, 12h, and 24h. We calculated the volume (V) of the right hind limb thigh and the edema reduction rate (DR) at each time point to reflect the degree of edema reduction, and calculated the average values. The calculation formula is as follows: Note: V1 is the volume of the right hind leg thigh of a nude mouse 0h after modeling; V0 is the volume of the right hind leg thigh of a nude mouse before modeling; V2 is the volume of the right hind leg thigh of a nude mouse 12h or 24h.

[0066] (4) Experimental results The body weight and right hind leg thigh volume of each group of nude mice were recorded at different time points. Figure 5 The swelling reduction rate was calculated in the manner described above, and the results are shown in Tables 4 to 6.

[0067] Table 4: Body weight of nude mice in each group Table 5: Thigh volume of the right hind leg of nude mice in each group Table 6: Swelling reduction rate of each group of nude mice at 12h and 24h (5) Experimental conclusions: The subcutaneous soft tissue swelling model of the right hind limb thigh in nude mice constructed in this experiment evaluated the effects of different gradient design osmotic pressures (400, 600, 800, 1000, 1200 mOsm / L) on CMCS-Mg². + The results showed that the gel had a de-inflammatory effect: Compared to blank CMCS gel, the CMCS-Mg² gels with different osmotic pressure gradients prepared in this invention... + Gels can all reduce tissue swelling to some extent.

[0068] 1000 mOsm / LCMCS Mg² + The gel significantly reduced tissue swelling 12 h and 24 h after application to the body surface (P < 0.0001), and the swelling reduction was significantly better than other experimental groups (i.e., Example 1 of the present invention is the best example).

[0069] No abnormal fluctuations in body weight were observed in any group of experimental animals, and no obvious adverse reactions such as skin ulceration were observed, indicating that under the five osmotic pressure conditions, CMCS-Mg² + The gel has no obvious toxicity or skin irritation.

[0070] Experimental Example 3: Safety Investigation of Hypertonic Gel Products

[0071] This experimental example uses animal skin tissue section staining, dynamic monitoring of water absorption osmotic pressure, and DAPI fluorescence tracing experiments to study the effects of 1000 mOsm / L CMCS-Mg²⁺. + The safety and water absorption properties of the hypertonic gel were evaluated.

[0072] (1) HE staining and Masson staining of animal skin Skin tissue from the hind thighs of nude mice in each group of Experiment 2 was fixed, embedded in paraffin, sectioned, and then stained with H&E and Masson staining. The staining results are shown in the figures below. Figure 6 and Figure 7 .

[0073] Depend on Figure 6 HE staining results of nude mouse skin tissues from various groups showed that, compared with the model control group and the blank CMCS gel group, different osmotic gradients of CMCS-Mg²... + The skin epidermis, dermis, and subcutaneous tissue structure in the gel group remained intact, with no obvious inflammatory cell infiltration, tissue necrosis, or structural damage observed. Furthermore, compared to the model control group, the levels of CMCS-Mg² in each group were significantly lower. + The intercellular spaces of the skin tissue in the gel group narrowed, suggesting that the gel has a certain tendency to improve local tissue swelling.

[0074] Depend on Figure 7 Masson staining results showed that the collagen fibers were arranged in a regular manner, with no obvious fibrosis or pathological hyperplasia.

[0075] HE staining and Masson staining results showed that the hyperosmotic gel of this invention, within an osmotic pressure range of 600 mOsm / L-1200 mOsm / L, CMCS-Mg² + The gel has no obvious toxicity or irritation to the skin and is safe for the skin.

[0076] (2) Osmotic pressure change of 1000 mOsm / L hypertonic gel in water Freshly prepared 1000 mOsm / L hypertonic gel was placed under sealed and immersion conditions, and samples were taken at 0 h, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h, 24 h, 25 h, and 26 h. The osmotic pressure was measured using a freezing point osmometer. The statistical results are shown in Table 7, and osmotic pressure-time curves were plotted. Figure 8 .

[0077] Table 7: Osmotic pressure of 1000 mOsm / L hypertonic gel after water absorption and sealing treatment From Table 7 and Figure 8 The results show that the osmotic pressure of the 1000 mOsm / L hypertonic gel prepared in this invention continuously decreased over time after immersion in water, dropping from approximately 1000 mOsm / L to approximately 300 mOsm / L within 26 hours, falling within the isotonic range recognized by the Chinese Pharmacopoeia. Meanwhile, the osmotic pressure of the sealed storage group remained consistently at approximately 1000 mOsm / L. This result indicates that the gel has good water absorption properties and can gradually reduce its own osmotic pressure by absorbing water.

[0078] (3) Fluorescence images of 1000 mOsm / L hypertonic gel after soaking in fluorescent solution for 6, 12, and 24 h respectively. Figure 9 ).

[0079] Figure 9 The DAPI fluorescence imaging results showed that the fluorescence intensity inside the gel gradually increased with the extension of soaking time. The fluorescence signal was weak at 0 h, and the blue fluorescence was significantly enhanced at 24 h, which directly characterized the process of water penetrating into the gel, and was consistent with the result of continuous decrease in osmotic pressure.

[0080] In summary, CMCS-Mg² + Hypertonic gels combine good anti-swelling effects, water absorption properties, and biocompatibility, providing experimental evidence and data support for the subsequent clinical translation of anti-swelling gels.

[0081] 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 topical hypertonic gel, characterized in that, It is a homogeneous gel with an osmotic pressure of 600 mOsm / L to 1200 mOsm / L, composed of a core substrate and functional components; the core substrate is a gel matrix, and the functional components are metal salts.

2. The topical hypertonic gel according to claim 1, characterized in that, The gel matrix is ​​selected from any one of carboxymethyl chitosan, sodium carboxymethyl cellulose, and alginate.

3. The topical hypertonic gel according to claim 1, characterized in that, The metal salt is selected from any one of magnesium salts, iron salts, and aluminum salts.

4. The topical hypertonic gel according to claim 1, characterized in that, The gel matrix is ​​carboxymethyl chitosan; the metal salt is magnesium sulfate.

5. The topical hypertonic gel according to claim 4, characterized in that, The components, by mass percentage, are: carboxymethyl chitosan 4wt%–12wt%, magnesium sulfate 6wt%–18wt%, and the remainder is purified water.

6. The method for preparing a topical hypertonic gel according to claim 5, characterized in that, Includes the following steps: S1. Substrate swelling: Under normal temperature conditions, the carboxymethyl chitosan powder is uniformly dispersed in purified water until the powder is completely swollen and the system is uniform and transparent to obtain the CMCS matrix; S2. Preparation of magnesium sulfate solution: Add the magnesium sulfate to pure water, vortex until the magnesium sulfate is completely dissolved, and let stand at room temperature; S3. Gel preparation: Add the magnesium sulfate solution and pure water to the above CMCS matrix and stir until the magnesium sulfate solution is fully dispersed in the CMCS matrix. The carboxymethyl chitosan crosslinks with magnesium ions to form a stable three-dimensional network structure, thus obtaining a stable gel.

7. The method for preparing a topical hypertonic gel according to claim 6, characterized in that, In S1, at room temperature, pure water is first placed in a stirrer and stirred, then carboxymethyl chitosan powder is added in batches and stirred continuously for 1 to 3 hours before degassing.

8. The method for preparing a topical hypertonic gel according to claim 6, characterized in that, In S2, the vortex oscillation processing time is 1 min to 2 min.

9. The method for preparing a topical hypertonic gel according to claim 6, characterized in that, In S3, the stirring time is 1h to 3h.

10. The application of a topical hypertonic gel as described in any one of claims 1 to 5, or a gel prepared by the method described in any one of claims 6 to 9, characterized in that, It is used to reduce swelling in soft tissues on the body surface.

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