Medicinal sponge sheet for inhibiting growth of nasal polyp as well as preparation method and application of medicinal sponge sheet

Abstract

The invention belongs to the technical field of medicine, and discloses a medicinal sponge sheet for inhibiting growth of nasal polyp, the medicinal sponge sheet is composed of a medical grade absorptive gelatin sponge base material, triamcinolone acetonide and hydroxypropyl methyl cellulose, the medicinal sponge sheet adopts the medical gelatin base material with the porosity of 95% and the water absorption expansion rate of less than or equal to 30%, the size is 60mm * 20mm * 5mm, each sheet loads 60mg of triamcinolone acetonide, and the hydroxypropyl methyl cellulose is added into the medicinal sponge sheet. And 10% of hydroxypropyl methyl cellulose with the molecular weight of 35000 Da and the viscosity of 700 mPa.s is supplemented to construct a slow release system. Efficient and safe treatment of chronic nasosinusitis with nasal polyp is achieved through multi-dimensional innovative design, the three-dimensional interpenetrating pore structure of the medical gelatin base material provides an ideal carrier for drug release, 60%-70% of triamcinolone acetonide is continuously released within 7 days through the gradient slow release technology, a local high-concentration microenvironment is constructed, and the effect of treating chronic nasosinusitis with nasal polyp is achieved. The device directly acts on the polyp root to block an inflammation cascade reaction; in the formula, hydroxypropyl methyl cellulose is used as a core slow-release carrier.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and specifically relates to a medicinal sponge tablet for inhibiting the growth of nasal polyps, and a preparation method and application thereof. Background Art

[0002] Nasal polyps are chronic inflammatory diseases of the nasal and sinus mucosa. Their occurrence and development are closely related to factors such as genetics, abnormal immune function, abnormal nasal anatomical structure, and bacterial and fungal infections. Patients often experience persistent nasal congestion, increased mucous or purulent secretions, decreased sense of smell, and even sleep disorders due to the proliferation of polyp tissue, which seriously affects their quality of life. Current clinical treatment mainly relies on glucocorticoid drugs to control inflammation and endoscopic surgery to remove polyps. However, the use of systemic hormones is prone to side effects such as adrenocortical suppression, and traditional snare surgery has a high recurrence rate due to its inability to completely remove the diseased tissue in the sinuses. Although gelatin sponge is widely used in postoperative hemostasis and wound repair due to its good biocompatibility and degradability, its insufficient hydrophilicity leads to limited blood absorption, and it lacks antibacterial and anti-inflammatory functions. Sponge residue is prone to secondary infection in the treatment of infected wounds. Summary of the Invention

[0003] The purpose of the present invention is to provide a medicinal sponge tablet for inhibiting the growth of nasal polyps and its preparation method and application, so as to solve the problems raised in the above background technology.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a medicinal sponge sheet for inhibiting the growth of nasal polyps, comprising a medical-grade absorbable gelatin sponge substrate, triamcinolone acetonide, and hydroxypropyl methylcellulose. The medicinal sponge sheet utilizes a medical gelatin substrate with a porosity of 85%-95% and a water absorption expansion rate of ≤30%, and has a size of 60 mm × 20 mm × 5 mm. Each sheet is loaded with 40-80 mg of triamcinolone acetonide and supplemented with 10% hydroxypropyl methylcellulose with a molecular weight of 10,000-50,000 Da and a viscosity of 400-1000 mPa·s to form a sustained-release system. The surface can be coated with dexamethasone sodium phosphate or gentamicin, thereby achieving anti-inflammatory and antibacterial synergy through drug synergy.

[0005] Preferably, the medicinal sponge sheet adopts a spray drying method to evenly coat the synergistic ingredients on the sponge surface, the drying temperature is less than or equal to 40 degrees, and the coating thickness is precisely controlled at 5-10 μm to avoid sudden release of the drug; the drug content decreases within 6 months to ensure the long-term stability of the coating.

[0006] Preferably, the medicinal sponge sheet is freeze-dried to form an interpenetrating network structure, and the pore size is precisely controlled at 50-200 μm, which not only ensures uniform distribution of the drug, but also ensures sufficient penetration of nasal secretions; its wet tensile strength is above 0.5 MPa, and it maintains structural integrity when packed, perfectly adapting to the anatomical surface of the nasal cavity, achieving a balance between therapeutic fit and mechanical properties.

[0007] Preferably, the medicinal sponge tablet constructs a sustained-release system through HPMC. In vitro tests show that triamcinolone acetonide is continuously released at 65% within 7 days, effectively avoiding sudden release. After nasal administration to rats, the local concentration of the drug reaches 15-20 times the systemic blood concentration, and the systemic exposure is less than 5%, achieving highly efficient and low-toxic nasal targeted treatment.

[0008] Preferably, the medicinal sponge sheet constructs an efficient drug sustained-release system by optimizing the molecular weight and viscosity properties of hydroxypropyl methylcellulose; HPMC with a molecular weight of 10,000-50,000Da is selected to form a three-dimensional network gel structure after absorbing water, extending the release period of triamcinolone acetonide through a swelling-diffusion mechanism, and achieving a gradient release of 60%-70% within 7 days; and HPMC with a viscosity of 400-1000mPa·s exhibits optimal rheological properties in the composite solution, which can not only evenly disperse drug particles but also avoid clogging of the gelatin sponge pores caused by high viscosity, thereby ensuring a balance between efficient loading of drug molecules in the sponge matrix and release kinetics.

[0009] Preferably, the specific steps of the preparation method are as follows: S1: Substrate cutting and sterilization Medical-grade gelatin sponge is precisely cut to a size of 60mm x 20mm x 5mm, sterilized using ethylene oxide to ensure sterility, and then vacuum-dried to control the moisture content to less than or equal to 2%; S2: Preparation of drug compound solution Under sterile conditions, triamcinolone acetonide was dissolved in the hydroxypropyl methylcellulose aqueous solution and stirred continuously until completely dissolved to form a uniform drug sustained-release carrier solution; S3: Vacuum negative pressure drug loading The pretreated gelatin sponge was immersed in the composite solution and adsorbed under a vacuum pressure of -0.08 MPa for 45 minutes until the sponge weight gain reached 80%-90%, and then centrifuged at 1000 rpm for five minutes to remove the residual solution on the surface; S4: Spray application of synergistic ingredients Prepare a coating solution containing dexamethasone sodium phosphate or gentamicin, add 2% polyvinyl alcohol as a film-forming agent, and spray the coating solution evenly on the surface of the medical sponge sheet using a spray drying method to form a stable coating with a thickness of 5-10 μm; S5: Low temperature drying and packaging storage The coated medicinal sponge sheet is low-temperature dried at 35°C ± 2°C until the moisture content is less than or equal to 5%, cut into individual pieces, and sealed in an aluminum foil bag and stored in nitrogen to ensure long-term stability.

[0010] Preferably, strict quality control is implemented during the preparation process: the content of triamcinolone acetonide is detected by HPLC; and a microbial limit test is performed simultaneously, with the bacterial count of each sponge piece being less than or equal to 10 CFU / g and the fungal count being less than or equal to 10 CFU / g.

[0011] Preferably, the medicinal sponge tablet is developed for chronic sinusitis with nasal polyps and recurrent nasal polyps, and adopts nasal packing targeted drug delivery technology; in clinical use, after the nasal cavity is cleaned, special tweezers are used to accurately pack the sponge into the root of the polyps in the middle nasal meatus, and it is replaced every 2-3 weeks, with 3-4 times as a course of treatment; it can be used in combination with mometasone furoate nasal spray, through the synergistic effect of local sustained-release triamcinolone acetonide and surface spray.

[0012] Preferably, after 12 weeks of standardized treatment, the patient's nasal polyp volume score decreased by ≥2 points compared with the baseline, and the clinical efficacy was significant; long-term follow-up data showed that the recurrence rate 6 months after surgery was lower than that of the simple endoscopic sinus surgery group.

[0013] The beneficial effects of the present invention are as follows: 1. The present invention achieves efficient and safe treatment of chronic sinusitis with nasal polyps through multi-dimensional innovative design: the three-dimensional interpenetrating pore structure of its medical gelatin substrate not only provides an ideal carrier for drug release, but also uses gradient sustained-release technology to enable triamcinolone acetonide to continuously release 60%-70% within 7 days, creating a local high-concentration microenvironment, directly acting on the root of the polyp to block the inflammatory cascade reaction; the hydroxypropyl methylcellulose used in the formula as the core sustained-release carrier, with its molecular weight of 10,000-50,000Da, forms a gel barrier, effectively avoiding the fluctuation of blood drug concentration caused by sudden drug release, and controlling the systemic absorption rate to a safety threshold of less than 5%, significantly reducing the risks caused by traditional hormone therapy. The clinical program innovatively introduces modular synergistic coating technology, which can spray dexamethasone sodium phosphate or gentamicin according to the individual needs of patients, forming a dual protective layer with anti-inflammatory / antibacterial properties. A large-sample clinical trial has confirmed that the recurrence rate 6 months after surgery can be reduced by 40% compared with the simple surgery group; in terms of humanized design, the pre-cut size of 60mm×20mm×5mm perfectly fits the anatomical structure of the nasal cavity, and the flexibility of medical-grade gelatin ensures a non-invasive packing experience. Combined with a convenient replacement cycle every 2-3 weeks, patient compliance is increased by more than 65% compared with traditional nasal sprays. It is particularly suitable for patients with recurrent nasal polyps who require long-term management.

[0014] 2. The present invention innovatively combines a triamcinolone acetonide sustained-release system with a chitosan oligosaccharide-functionalized gelatin substrate through a composite medical sponge material with precise treatment and tissue repair functions. This material constructs a three-dimensional interpenetrating network structure using medical-grade gelatin, achieving a gradient release of 60%-70% of triamcinolone acetonide over 7 days. Combined with HPMC sustained-release carrier technology, the local drug concentration reaches 10-20 times that of systemic administration, significantly reducing the risk of adrenal cortex suppression. In particular, water-soluble chitosan oligosaccharides with a molecular weight of ≤3200Da are evenly embedded in the gelatin skeleton, and their positive charge characteristics are used to form a broad-spectrum antibacterial barrier, with an inhibition rate of over 85% against Staphylococcus aureus, while activating the fibroblast migration pathway and promoting the epithelialization process; the sponge sheet adopts a 60mm×20mm×5mm pre-cut design, and after ethylene oxide sterilization, the water content is ≤2%, which perfectly fits the nasal anatomical structure to achieve non-invasive packing. The patient's compliance of self-replacement every 2-3 weeks is significantly improved compared with traditional therapies; preclinical studies have shown that this material reduces the recurrence rate of nasal polyps 6 months after surgery, and the healing speed in the infectious wound model is faster than that of traditional gelatin sponges, showing broad prospects for translational applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 The present invention is a schematic flow chart of the preparation method. DETAILED DESCRIPTION

[0016] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 efforts are within the scope of protection of the present invention.

[0017] like Figure 1 As shown, an embodiment of the present invention provides a medicinal sponge sheet for inhibiting the growth of nasal polyps. The sheet is composed of a medical-grade absorbable gelatin sponge substrate, triamcinolone acetonide, and hydroxypropyl methylcellulose (HPMC). The sheet uses a medical gelatin substrate with a porosity of 85%-95% and a water absorption expansion rate of ≤30%. The sheet has a size of 60mm×20mm×5mm. Each sheet is loaded with 40-80mg of triamcinolone acetonide and supplemented with 5%-15% of hydroxypropyl methylcellulose (HPMC) with a molecular weight of 10,000-50,000Da and a viscosity of 400-1000mPa·s to construct a sustained-release system. The surface can be coated with dexamethasone sodium phosphate (1%-5%) or gentamicin (0.1%-1%) to achieve anti-inflammatory and antibacterial synergy through drug synergy.

[0018] Among them, the medicinal sponge sheet adopts the spray drying method to evenly coat the synergistic ingredients on the sponge surface. The drying temperature is less than or equal to 40 degrees, and the coating thickness is precisely controlled at 5-10μm to avoid sudden release of drugs. It is verified by the accelerated test at 40℃±2℃ / 75%RH±5%RH that the drug content decrease rate within 6 months is less than 5%, ensuring the long-term stability of the coating.

[0019] Among them, the medicinal sponge sheet is freeze-dried to form an interpenetrating network structure, and the pore size is precisely controlled at 50-200μm, which not only ensures the uniform distribution of the drug, but also ensures sufficient penetration of nasal secretions; its wet tensile strength is above 0.5MPa, and it maintains structural integrity when packed, perfectly adapting to the anatomical surface of the nasal cavity, achieving a balance between therapeutic fit and mechanical properties.

[0020] Among them, the medicinal sponge tablet uses HPMC to construct a sustained-release system. In vitro tests show that triamcinolone acetonide is continuously released at 60%-70% within 7 days, effectively avoiding sudden release; after nasal administration to rats, the local concentration of the drug reaches 15-20 times the systemic blood concentration, and the systemic exposure is less than 5%, achieving highly efficient and low-toxic nasal targeted treatment.

[0021] The medicinal sponge tablet constructs a highly efficient drug sustained-release system by optimizing the molecular weight and viscosity properties of hydroxypropyl methylcellulose (HPMC). HPMC with a molecular weight of 10,000-50,000 Da forms a three-dimensional network gel structure after absorbing water, extending the release period of triamcinolone acetonide through a swelling-diffusion mechanism, achieving a gradient release of 60%-70% over 7 days. HPMC with a viscosity of 400-1000 mPa·s exhibits optimal rheological properties in the composite solution, which can evenly disperse drug particles while avoiding clogging of the gelatin sponge pores caused by high viscosity, ensuring a balance between efficient loading of drug molecules in the sponge matrix and release kinetics.

[0022] This medicinal sponge tablet creates a highly effective sustained-release drug system by precisely controlling the molecular weight and viscosity of hydroxypropyl methylcellulose (HPMC). HPMC with a molecular weight of 10,000-50,000 Da forms a three-dimensional network gel structure upon water absorption. This structure utilizes a swelling-diffusion mechanism to significantly prolong the release period of triamcinolone acetonide, achieving a gradient release of 60%-70% over 7 days, ensuring sustained drug action. Furthermore, HPMC with a viscosity of 400-1000 mPa·s exhibits optimal rheological properties in the composite solution, uniformly dispersing drug particles while preventing clogging of the gelatin sponge pores due to high viscosity. This ensures efficient drug loading within the sponge matrix and a balanced release kinetics, thereby enhancing therapeutic efficacy and patient compliance.

[0023] The specific steps of the preparation method are as follows: S1: Substrate cutting and sterilization Medical-grade gelatin sponge was precisely cut to a size of 60 mm × 20 mm × 5 mm and sterilized using ethylene oxide (EO) (EO concentration 600 mg / L, temperature 55°C, relative humidity 60%, for 3 hours) to ensure sterility. The water content was then controlled to less than or equal to 2% by vacuum drying (-0.09 MPa, 30°C, for 2 hours). S2: Preparation of drug compound solution Under sterile conditions, triamcinolone acetonide (40-80 mg / mL) was dissolved in a hydroxypropyl methylcellulose (HPMC) aqueous solution (50-150 mg / mL) and stirred continuously until completely dissolved to form a uniform drug sustained-release carrier solution; S3: Vacuum negative pressure drug loading The pretreated gelatin sponge was immersed in the composite solution and adsorbed under a vacuum pressure of -0.08 MPa for 30-60 minutes until the sponge weight gain reached 80%-90%, and then centrifuged at 1000 rpm for five minutes to remove the residual drug solution on the surface; S4: Spray application of synergistic ingredients A coating solution containing dexamethasone sodium phosphate (2 mg / mL) or gentamicin (0.5 mg / mL) was prepared, and 2% polyvinyl alcohol (PVA) was added as a film-forming agent. The coating solution was evenly sprayed onto the surface of the medical sponge sheet using a spray drying method (atomization pressure 0.2 MPa, inlet air temperature 60°C, outlet air temperature 40°C) to form a stable coating with a thickness of 5-10 μm. S5: Low temperature drying and packaging storage The coated medicinal sponge sheet is low-temperature dried at 35°C ± 2°C until the moisture content is less than or equal to 5%, cut into individual pieces, and sealed in an aluminum foil bag and stored in nitrogen to ensure long-term stability.

[0024] This preparation method achieves process innovation and quality assurance through five core steps: 1) Ethylene oxide sterilization combined with vacuum drying achieves a 99.9% sterilization rate at 55°C while precisely controlling the substrate's moisture content to below 2%, ensuring sponge structural stability. 2) The HPMC-triamcinolone acetonide complex is constructed under aseptic conditions, forming a three-dimensional sustained-release matrix with HPMC (30,000 Da) to achieve a 7-day gradient release. 3) A vacuum adsorption process achieves a drug loading rate of 85%, while centrifugal desorption eliminates surface residues. 4) Spray drying deposits an ultra-thin coating of 5-10 μm, synergistically enhancing anti-infective efficacy with dexamethasone sodium phosphate and gentamicin. 5) Low-temperature drying at 35°C combined with nitrogen-filled packaging limits drug degradation to 4.2% per six months, extending the shelf life to 24 months. The entire process undergoes 12 online testing nodes to ensure that each tablet meets the sterility standards of the Chinese Pharmacopoeia, providing a safe and effective carrier platform for the treatment of nasal polyps.

[0025] Strict quality control is implemented during the preparation process: the HPLC method is used to detect the content of triamcinolone acetonide to ensure a recovery rate of 98%-102% and an RSD of less than 2%. At the same time, a microbial limit test is performed, with the number of bacteria on each sponge piece ≤10 CFU / g and the number of fungi ≤10 CFU / g, fully complying with the sterile preparation standards of the 2025 edition of the Chinese Pharmacopoeia.

[0026] The preparation process of this medicinal sponge tablet implements a dual set of stringent quality controls: 1) High-performance liquid chromatography (HPLC) is used to accurately determine the content of triamcinolone acetonide, with a recovery rate strictly controlled at 98%-102% and an RSD of <2%. This ensures accurate dosage and highly consistent release behavior for each tablet, guaranteeing reproducible clinical efficacy. 2) Comprehensive microbial limit testing is performed, with bacterial counts ≤10 CFU / g and fungal counts ≤10 CFU / g. This improves cleanliness by 50% compared to the sterile preparation standards of the 2025 edition of the Chinese Pharmacopoeia, significantly reducing the risk of postoperative infection. This dual quality control system not only ensures the reliability of targeted drug dosage, but also enhances product safety through sterility assurance, providing patients with chronic sinusitis with an innovative, effective and reliable treatment option.

[0027] Among them, this medicinal sponge tablet is developed for chronic sinusitis with nasal polyps (CRS with NP) and recurrent nasal polyps (CRSwNP), and adopts nasal packing targeted drug delivery technology; in clinical use, after the nasal cavity is cleaned, special tweezers are used to accurately pack the sponge into the root of the polyps in the middle nasal meatus, and it is replaced every 2-3 weeks, and 3-4 times constitutes a course of treatment; it can be used in combination with mometasone furoate nasal spray (once a day), through the synergistic effect of local sustained-release triamcinolone acetonide and surface spray, it can significantly inhibit polyp growth and reduce inflammatory response; a one-week interval is required between treatment courses to evaluate the efficacy, and the total treatment cycle shall not exceed 12 weeks, taking into account both therapeutic effect and medication safety.

[0028] This medicinal sponge sheet is designed for chronic sinusitis with nasal polyps and recurrent nasal polyps. It uses nasal packing targeted drug delivery technology to accurately locate the root of the polyps in the middle nasal passages and significantly increase local drug concentration. It is replaced every 2-3 weeks, and a course of treatment consists of 3-4 times, which is convenient for patients to use. Combined with mometasone furoate nasal spray, it effectively inhibits polyp growth and reduces inflammatory response through the synergistic effect of local sustained-release triamcinolone acetonide and surface spray. The interval between treatment courses is one week, which is convenient for evaluating the efficacy. The total treatment cycle does not exceed 12 weeks, taking into account both the therapeutic effect and the safety of the drug, providing patients with an efficient, convenient and safe treatment plan.

[0029] Among them, after 12 weeks of standardized treatment, the patient's nasal polyp volume score (NPS) decreased by ≥2 points compared with the baseline, and the clinical efficacy was significant; long-term follow-up data showed that the recurrence rate 6 months after surgery was 40% lower than that of the simple endoscopic sinus surgery group (P < 0.05); this improved efficacy was due to the local high-concentration drug delivery in the nasal cavity achieved by the drug sustained-release system, which can not only continuously inhibit polyp proliferation through triamcinolone acetonide's anti-inflammatory effect, but also reduce the risk of systemic hormone exposure, providing patients with chronic sinusitis and nasal polyps with an innovative treatment plan that is both effective and safe.

[0030] Example: Preparation and clinical application of a medicinal sponge tablet for inhibiting the growth of nasal polyps 1. Materials and recipe Substrate: Use medical-grade gelatin sponge with a porosity of 90% and a water absorption expansion rate of 25%, and cut it into a size of 60mm×20mm×5mm.

[0031] Active ingredient: Each tablet contains 60 mg of triamcinolone acetonide, supplemented with 10% HPMC with a molecular weight of 30,000 Da and a viscosity of 800 mPa·s to construct a sustained-release system.

[0032] Synergistic coating: The surface is sprayed with a composite coating containing 2% dexamethasone sodium phosphate and 0.5% gentamicin. The coating thickness is precisely controlled at 8μm, and 2% polyvinyl alcohol (PVA) is used as a film-forming agent.

[0033] 2. Preparation process S1: Substrate pretreatment The gelatin sponge was sterilized with ethylene oxide (600 mg / L, 55°C, relative humidity 60%, for 3 hours) and vacuum dried (-0.09 MPa, 30°C, for 2 hours) to a water content of 1.8%.

[0034] S2: Preparation of drug compound solution Under sterile conditions, 60 mg of triamcinolone acetonide was dissolved in 100 mg / mL HPMC solution and stirred continuously until completely dissolved to form a uniform sustained-release carrier solution.

[0035] S3: Vacuum negative pressure drug loading The sponge was immersed in the composite solution and adsorbed under vacuum at -0.08 MPa for 45 minutes, with a weight gain of 85%. The residual liquid on the surface was removed by centrifugation (1000 rpm, 5 minutes).

[0036] S4: Enhanced coating spraying A coating solution containing 2% dexamethasone sodium phosphate, 0.5% gentamicin and 2% PVA was prepared and spray-dried (atomization pressure 0.2 MPa, air inlet temperature 60°C, air outlet temperature 40°C) to form an 8 μm coating.

[0037] S5: Low temperature drying and packaging Dry at 35℃ to a moisture content of 4.8%, seal the individual pieces in aluminum foil bags, and store under nitrogen.

[0038] 3. Quality Control Drug content: The content of triamcinolone acetonide was determined by HPLC and was 58.2 mg (recovery rate 97%, RSD=1.8%).

[0039] Microbial limits: bacterial count 8 CFU / g, fungal count 5 CFU / g, in line with the sterility standards of the 2025 edition of the Chinese Pharmacopoeia.

[0040] Stability: After 6 months of accelerated testing at 40°C / 75%RH, the drug content decreased by 4.2%, and the coating remained intact without falling off.

[0041] 4. Clinical application plan Indications: Chronic rhinosinusitis with nasal polyps (CRS with NP) and recurrent sinusitis with nasal polyps (CRSwNP).

[0042] Directions: After cleaning the nasal cavity, use special tweezers to pack the sponge into the root of the middle nasal passage polyp. Replace it every 2 weeks, and 4 times constitute a course of treatment.

[0043] Combined with mometasone furoate nasal spray (once a day), with an interval of 1 week between treatment courses, and a total treatment course of 12 weeks.

[0044] 5. Efficacy Evaluation Nasal polyp volume score (NPS): After 12 weeks, NPS decreased by 2.8 points compared with baseline (P < 0.01), and the clinical efficacy was 89%.

[0045] Recurrence rate: After 6 months of follow-up, the recurrence rate was 9.2%, which was 40% lower than that of the simple surgery group (15.3%) (P < 0.05).

[0046] Safety: Systemic hormone exposure is <5%, and no cases of adrenal cortex suppression have been reported.

[0047] Patient compliance: The non-invasive design and 2-week replacement cycle increase compliance to 92%.

[0048] 6. Innovation Advantage Precise sustained release: HPMC three-dimensional gel network achieves 65% gradient release of triamcinolone acetonide within 7 days, with local concentration reaching 18 times that of the whole body.

[0049] Synergistic effect: The composite coating inhibits postoperative infection, promotes inflammation resolution, and significantly reduces the recurrence rate.

[0050] Mechanical properties: Wet tensile strength of 0.5MPa, perfectly adapts to the anatomical surface of the nasal cavity, and has a high degree of treatment fit.

[0051] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0052] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A medicinal sponge sheet for inhibiting the growth of nasal polyps, comprising a medical-grade absorbable gelatin sponge substrate, triamcinolone acetonide, and hydroxypropyl methylcellulose, characterized in that: The medicinal sponge sheet uses a medical gelatin substrate with a porosity of 95% and a water absorption expansion rate of less than or equal to 30%. It has a size of 60mm×20mm×5mm. Each sheet is loaded with 60mg of triamcinolone acetonide and supplemented with 10% hydroxypropyl methylcellulose with a molecular weight of 35,000Da and a viscosity of 700mPa·s to construct a sustained-release system. The surface can be coated with dexamethasone sodium phosphate or gentamicin to achieve anti-inflammatory and antibacterial synergy through drug synergy.

2. The medicinal sponge tablet for inhibiting the growth of nasal polyps according to claim 1, characterized in that: The medicinal sponge sheet adopts a spray drying method to evenly coat the synergistic ingredients on the sponge surface. The drying temperature is less than or equal to 40 degrees. The coating thickness is precisely controlled at 5-10 μm to avoid sudden release of the drug. The drug content decreases within 6 months to ensure the long-term stability of the coating.

3. The medicinal sponge tablet for inhibiting the growth of nasal polyps according to claim 1, characterized in that: The medicinal sponge sheet is freeze-dried to form an interpenetrating network structure with a pore size precisely controlled at 50-200 μm, which not only ensures uniform distribution of the drug but also ensures sufficient penetration of nasal secretions; Its wet tensile strength is over 0.5MPa, maintaining structural integrity during packing, perfectly adapting to the anatomical surface of the nasal cavity, and achieving a balance between therapeutic fit and mechanical properties.

4. The medicinal sponge tablet for inhibiting the growth of nasal polyps according to claim 1, characterized in that: The medicinal sponge tablet uses HPMC to construct a sustained-release system. In vitro tests show that triamcinolone acetonide is continuously released at 65% within 7 days, effectively avoiding sudden release. After nasal administration in rats, the local concentration of the drug reaches 15-20 times the systemic blood concentration, and the systemic exposure is less than 5%, achieving highly efficient and low-toxic nasal targeted treatment.

5. The medicinal sponge tablet for inhibiting the growth of nasal polyps according to claim 1, characterized in that: The medicinal sponge tablet constructs a highly efficient drug sustained-release system by optimizing the molecular weight and viscosity properties of hydroxypropyl methylcellulose. HPMC with a molecular weight of 10,000-50,000 Da is selected to form a three-dimensional network gel structure after absorbing water, extending the release period of triamcinolone acetonide through a swelling-diffusion mechanism, achieving a gradient release of 60%-70% within 7 days. HPMC with a viscosity of 400-1000 mPa·s exhibits optimal rheological properties in the composite solution, which can evenly disperse drug particles while avoiding clogging of the gelatin sponge pores caused by high viscosity, ensuring a balance between efficient loading of drug molecules in the sponge matrix and release kinetics.

6. A method for preparing a medicinal sponge tablet for inhibiting the growth of nasal polyps, characterized in that: The specific steps of this preparation method are as follows: S1: Substrate cutting and sterilization Medical-grade gelatin sponge is precisely cut to a size of 60mm x 20mm x 5mm, sterilized using ethylene oxide to ensure sterility, and then vacuum-dried to control the moisture content to less than or equal to 2%; S2: Preparation of drug compound solution Under sterile conditions, triamcinolone acetonide was dissolved in the hydroxypropyl methylcellulose aqueous solution and stirred continuously until completely dissolved to form a uniform drug sustained-release carrier solution; S3: Vacuum negative pressure drug loading The pretreated gelatin sponge was immersed in the composite solution and adsorbed under a vacuum pressure of -0.08 MPa for 45 minutes until the sponge weight gain reached 80%-90%, and then centrifuged at 1000 rpm for five minutes to remove the residual solution on the surface; S4: Spray application of synergistic ingredients Prepare a coating solution containing dexamethasone sodium phosphate or gentamicin, add 2% polyvinyl alcohol as a film-forming agent, and spray the coating solution evenly on the surface of the medical sponge sheet using a spray drying method to form a stable coating with a thickness of 5-10 μm; S5: Low temperature drying and packaging storage The coated medicinal sponge sheet is low-temperature dried at 35°C ± 2°C until the moisture content is less than or equal to 5%, cut into individual pieces, and sealed in an aluminum foil bag and stored in nitrogen to ensure long-term stability.

7. The method for preparing a medicinal sponge tablet for inhibiting the growth of nasal polyps according to claim 6, characterized in that: Strict quality control is implemented during the preparation process: the content of triamcinolone acetonide is detected by HPLC; and a microbial limit test is performed simultaneously, with the bacterial count of each sponge piece being less than or equal to 10 CFU / g and the fungal count being less than or equal to 10 CFU / g.

8. Use of a medicinal sponge tablet in the preparation of a medicament for treating chronic sinusitis with nasal polyps, characterized in that: This medicinal sponge tablet is developed for chronic sinusitis with nasal polyps and recurrent nasal polyps, and adopts nasal packing targeted drug delivery technology; in clinical use, after the nasal cavity is cleaned, special tweezers are used to accurately pack the sponge into the root of the polyps in the middle nasal cavity. It is replaced every 2-3 weeks, and 3-4 times constitutes a course of treatment; it can be used in combination with mometasone furoate nasal spray, through the synergistic effect of local sustained-release triamcinolone acetonide and surface spray.

9. Use of a medicinal sponge sheet according to claim 8 in preparing a medicament for treating chronic sinusitis with nasal polyps, characterized in that: After 12 weeks of standardized treatment with this application, the patient's nasal polyp volume score decreased by ≥2 points compared with the baseline, with significant clinical efficacy; long-term follow-up data showed that the recurrence rate 6 months after surgery was lower than that of the simple endoscopic sinus surgery group.

Images