Wound dressing pharmaceutical composition as well as preparation method and application thereof

Abstract

The invention relates to the field of wound nursing materials, and discloses a dressing pharmaceutical composition for wound nursing as well as a preparation method and application thereof. The dressing is composed of a polymer substrate layer and an active medicine layer, and is integrally prepared through an electrostatic spinning or spray deposition technology. The polymer substrate layer comprises a hydrophilic film-forming component and a hydrophobic film-forming component, the hydrophilic film-forming component comprises a cross-linking agent and a gold-based nano enzyme, and the active drug layer comprises an alkenyl compound. According to the dressing pharmaceutical composition, through the synergistic effect of the polymer substrate layer and the active medicine layer, a functional barrier is formed on a wound surface, through the synergistic effect of active ingredients, the physical blocking and removing effects are achieved, bacterial infection is effectively inhibited, pathological products are removed, and therefore wound surface healing is promoted.

Description

Technical Field

[0001] This invention belongs to the field of wound care materials, specifically relating to a dressing composition for wounds, its preparation method and application. Background Technology

[0002] Wounds are a common and challenging health problem in clinical practice, especially when accompanied by infection or tissue necrosis, making treatment complex and significantly burdensome on healthcare. According to the World Health Organization, the risk of amputation due to severe wounds remains high globally, with a disability rate even exceeding that of some malignant tumors. The typical clinical feature of such wounds is full-thickness skin loss in the distal lower extremities, often accompanied by varying degrees of infection and tissue necrosis.

[0003] In the clinical treatment and management of wounds, the selection and application of dressings have always been crucial. Traditional dressings still have many limitations in terms of functional design and manufacturing processes. According to the Chinese guidelines for wound treatment and relevant domestic expert consensus, an ideal functional dressing should possess multiple characteristics, including exudate management, antibacterial and anti-inflammatory properties, maintenance of a moist healing environment, and promotion of tissue repair. However, most products currently on the market fail to fully meet these requirements: for example, traditional gauze can easily cause secondary damage to newly formed granulation tissue when changed (CN120865111A); hydrocolloid dressings are prone to infiltration and softening of surrounding skin when there is excessive exudate (CN116509629A); and while silver-containing dressings have a certain antibacterial effect, their activity is limited in duration and they lack the ability to effectively regulate the abnormal accumulation of metabolic end products in the wound microenvironment (CN117398237A).

[0004] The core mechanism of wound slow healing lies in the accumulation of pathological products (such as AGEs, advanced glycation end products) caused by metabolic abnormalities in the local microenvironment, which in turn induces persistent inflammatory responses, oxidative stress, and impaired angiogenesis, severely affecting the healing process. This complex pathophysiological mechanism requires modern dressings to not only meet basic coverage and protection functions, but also to have the ability to actively intervene in the wound microenvironment, including regulating abnormal metabolites, effectively fighting infection, precisely managing exudate, and promoting angiogenesis and granulation tissue formation, among other goals. Summary of the Invention

[0005] To address the limitations of existing dressings in terms of repair efficiency, exudate management, and large-scale production, this invention provides a wound dressing pharmaceutical composition, its preparation method, and its application.

[0006] This invention develops a three-layer integrated dressing composition, focusing on improving repair efficiency, optimizing exudate management, and promoting large-scale production. The product utilizes a nanofiber matrix to carry active ingredients, inhibiting AGEs formation and generating antibacterial substances through a cascade reaction. Simultaneously, it employs alkenyl compounds, precisely applied via a spray process, to achieve highly efficient and specific removal of deposited AGEs. The hydrophilic-hydrophobic composite structure enables unidirectional exudate drainage, effectively preventing peri-wound maceration. The production process is based on mature spinning technology, with readily available materials and a simple process, supporting stable large-scale production.

[0007] To achieve the aforementioned objectives, the present invention provides the following technical solution: The first objective of this invention is to provide a dressing pharmaceutical composition for wound care, the dressing pharmaceutical composition being a topical dressing comprising a functional layer, the functional layer being composed of a polymer base layer and a functional modification layer: The first layer includes a hydrophilic film-forming component, which comprises a hydrophilic polymer, a crosslinking agent, and ultra-small gold nanoparticles, wherein the ultra-small gold nanoparticles refer to gold nanoparticles with a particle size ≤ 5 nm. The second layer includes a hydrophobic film-forming component, wherein the hydrophobic film-forming component includes a hydrophobic polymer; The first and second layers constitute the polymer base layer; The third layer is the functional modification layer, which contains alkenyl compounds.

[0008] Furthermore, the dressing pharmaceutical composition also includes one or more of a backing layer, an adhesive layer, and a protective layer.

[0009] Furthermore, the hydrophilic polymer is selected from one or more of polyvinyl alcohol, cellulose and its derivatives, chitosan, polyvinylpyrrolidone, gelatin, and sodium alginate with different degrees of alcoholysis. The crosslinking agent is selected from one or more of glutaraldehyde, glycerol, genipin, maleic anhydride, citric acid, or diisocyanate; Preferably, the weight percentage of the hydrophilic polymer to the crosslinking agent is 0.4:1 to 20:1; the weight percentage of the ultrasmall gold nanoparticles to the hydrophilic polymer to the crosslinking agent is 1:5.4:13.6 to 9:20:1.

[0010] Furthermore, the hydrophobic polymer is selected from one or more of polyurethane, polystyrene, polyvinylidene fluoride, polytetrafluoroethylene, ethyl cellulose, polycaprolactone, or polymethylhydrosiloxane. The hydrophobic polymer is compounded with the hydrophilic film-forming component. Preferably, the mass ratio of the hydrophobic polymer to the hydrophilic polymer is 1:6.

[0011] Furthermore, the alkenyl compound is selected from one or more of 6-maleimide hexanoic acid, vinylpyridine, polyethylene glycol-vinyl sulfone, and acrylonitrile, and the mass ratio of the alkenyl compound to the ultra-small gold nanoparticles is 1:90 to 3:5.

[0012] Furthermore, the thickness of the first layer is 60 ± 2 μm, the thickness of the second layer is 48 ± 3 μm, and the spraying density of the third layer is 1.75 ~ 3.0 mg / cm³. 2 .

[0013] The hydrophilic layer, loaded with ultra-small gold nanoparticles, inhibits the formation of AGEs (Advanced Glycation End Products) by consuming glucose from the wound surface and generates reactive oxygen species through activation of peroxidase-like activity in the acidic microenvironment, achieving a self-cascade antibacterial effect. The hydrophobic layer forms a composite structure with the hydrophilic layer, enabling unidirectional drainage of wound exudate and acting as a physical barrier to prevent tissue adhesion. The spray layer removes AGEs deposited on the wound surface through click chemistry. The hydrophilic, hydrophobic, and spray layers synergistically achieve bidirectional regulation of AGEs formation inhibition and deposition removal.

[0014] A second objective of this invention is to provide a method for preparing the aforementioned dressing pharmaceutical composition, wherein the polymer base layer and the functional modification layer are integrally formed by electrospinning or spray deposition techniques, specifically including: (a) 1 wt% tetrachloroauric acid, 1 wt% sodium citrate, and 0.75 mM sodium borohydride were reacted at 0 °C in a volume ratio of 1:2:3. After centrifugation and filtration, ultra-small gold nanoparticles were obtained. A hydrophilic film-forming polymer, a crosslinking agent, and ultra-small gold nanoparticles are dispersed in a first solvent system, which is deionized water, to form a first spinning precursor. (b) Dispersing the hydrophobic polymer in a second solvent system, wherein the second solvent system is N,N-dimethyl sulfoxide, to form a second spinning precursor; (c) The first spinning precursor is shaped into a fiber substrate layer by electric field driving technology, and the second spinning precursor is sequentially applied to the surface of the substrate layer to form an integral biphase fiber at the interface between the two phases. (d) A functional modification layer is applied to the outer surface of the biphasic fiber carrier by spray deposition technology to form a dressing pharmaceutical composition; (e) The obtained dressing composition is dried and placed in a cutting machine to obtain a functional layer of the dressing composition. The functional layer is combined with one or more of a backing layer, an adhesive layer and a protective layer to obtain the dressing composition.

[0015] Furthermore, the concentration of the hydrophilic polymer in the first spinning precursor is 5% to 20 wt%, the loading of the ultra-small gold nanoparticles is 5 to 30 v / v, the concentration of the hydrophobic polymer in the second spinning precursor is 10% to 30 wt%, and the concentration of the alkenyl compound in the functional modification layer is 0.5% to 3% wt.

[0016] Furthermore, the electrospinning parameters of the first spinning precursor solution in (c) are: voltage of 10 ~ 30 kV, receiving distance of 5 ~ 20 cm, feed rate of 2.25 ~ 5.22 mL / h, humidity of 30% ~ 60%, and temperature of 20 ~ 70℃. Electrospinning parameters for the second spinning precursor solution: voltage 5 ~ 20 kV, receiving distance 8 ~ 30 cm, feed rate 0.75 ~ 2.25 mL / h, humidity 30% ~ 60%, temperature 20 ~ 70℃; (d) Spraying parameters for the functional modification layer: voltage 15 ~ 30 kV, receiving distance 5 ~ 20 cm, propulsion speed 0.15 ~ 1.5 mL / h, humidity 30% ~ 60%, and temperature 20 ~ 70℃.

[0017] A third object of the present invention is to provide the use of the aforementioned dressing pharmaceutical composition in the preparation of a wound dressing pharmaceutical for inhibiting and / or clearing wound pathological products, preferably AGEs.

[0018] This dressing drives exudate management through interlayer wettability differences: The spray side, along with the hydrophobic and hydrophilic sides, forms a unidirectional pumping system that actively and continuously drains excess exudate from the wound, effectively preventing maceration. Simultaneously, the outer hydrophilic layer, with its excellent absorbency and suitable water vapor permeability, maintains a stable moist healing environment. This mechanism synergizes with the dressing's drug therapy function: after absorbing exudate, the hydrophilic layer releases ultra-small gold nanoparticles, achieving cascade antibacterial action and inhibiting the formation of harmful AGEs (end-stage clearance); while the spray layer, in direct contact with the wound, neutralizes existing AGEs (end-stage clearance), achieving a dual breakthrough in exudate management and active treatment.

[0019] The dressing has a three-layer structure, and the spray side is applied directly to the wound during use. It is recommended to change it every 12-48 hours and can be used continuously for 1-6 months. The dressing allows for patient self-administration and monitoring, and can be flexibly cut to fit the wound size, with the duration of use and frequency of replacement dynamically adjusted based on healing progress.

[0020] Furthermore, this dressing can be used as part of a comprehensive treatment plan, in conjunction with various advanced therapies: it can be the preferred covering after surgical debridement and negative pressure wound therapy, effectively managing postoperative bleeding and exudation, preventing infection, and protecting granulation tissue. It can be used in conjunction with topical growth factors and antibiotics (as directed by a physician), as the ideal moist environment created by this dressing helps these medications achieve their optimal efficacy.

[0021] The advantages of this invention compared to existing technologies and treatment approaches are as follows: A dressing composition for wound treatment has been developed that integrates active ingredients with formulation processes and dressing properties.

[0022] (1) Through a three-layer structure design, this invention achieves targeted management of wound exudate. The hydrophilic layer can quickly absorb excess exudate, while the hydrophobic layer, through its interfacial properties, enables unidirectional drainage of liquid from the inside out, thereby significantly reducing the risk of tissue maceration and dressing adhesion. In addition, the dressing as a whole has good breathability, biocompatibility, and exudate absorption capacity, which helps maintain a moderately moist healing environment for the wound, improving patient comfort and treatment compliance.

[0023] (2) The preparation of this dressing relies on advanced electrospinning technology. Compared with traditional dressings, its biggest feature is that it can actively and biomimetously construct nanoscale fiber scaffolds, simulating the physical structure and function of the extracellular matrix, creating a guiding microenvironment for wound repair, and fundamentally promoting the healing process. At the manufacturing level, this technology achieves functional integration through multi-layer co-spinning, avoiding the complexity and instability of subsequent composite processes, and is compatible with existing production lines, thus ensuring the superior performance of the product and the economy of the production process from the source, giving it strong market competitiveness in terms of cost control and quality stability.

[0024] (3) Based on the pathological characteristics of wounds, this invention develops a dressing that can bidirectionally regulate AGEs (inhibit formation + remove deposition). It utilizes the dual enzyme-like activity of ultra-small gold nanoparticles (GOx catalyzes glucose → acidifies the microenvironment → activates POD → generates ·OH) to inhibit AGEs formation and achieve antibacterial self-circulation without external stimulation; at the same time, the dressing carries alkenyl compounds that have the unique function of directly removing AGEs. This multi-mechanism strategy of ultra-small gold nanoparticles and alkenyl compounds works synergistically under special ratios, significantly enhancing the dressing's comprehensive ability to regulate the wound microenvironment. Attached Figure Description

[0025] Figure 1 The exudate absorption rate of the dressing pharmaceutical composition described in this invention.

[0026] Figure 2 The water vapor permeability of the dressing pharmaceutical composition of the present invention.

[0027] Figure 3 The binding rate of AGEs in the dressing pharmaceutical composition of the present invention is given.

[0028] Figure 4 This refers to the cumulative release rate of the dressing pharmaceutical composition described in this invention.

[0029] Figure 5 The wound healing status of diabetic ulcer mice after receiving treatment in each group.

[0030] Figure 6 The AGEs content of diabetic ulcer mice after each treatment group.

[0031] Figure 7 This is a schematic diagram of the structure of the dressing pharmaceutical composition of the present invention. Detailed Implementation

[0032] The present invention will be further explained below with reference to the embodiments, but the embodiments do not limit the present invention in any way.

[0033] This invention provides a wound dressing pharmaceutical composition, its preparation method, and its application. The wound dressing pharmaceutical composition is prepared using a sequential electrospinning method, such as... Figure 7 As shown, the functional layer of the dressing composition comprises three layers: a hydrophilic film-forming component and a crosslinking agent as the first layer, providing highly efficient exudate absorption without degradation; a hydrophobic film-forming component as the second layer, improving interfacial compatibility and preventing delamination; the first and second layers constitute the polymer base layer; and a functional modification layer spray containing alkenyl compounds as the third layer, which directly contacts the wound and is hydrophobic, preventing adhesion and secondary damage upon contact with the wound.

[0034] I. Preparation of Wound Dressing Drug Composition (a) Tetrachloroauric acid was reacted with sodium citrate and sodium borohydride in a reaction system, and after centrifugation and filtration, ultra-small gold nanoparticles were obtained; the volume ratio of 1 wt% tetrachloroauric acid to 1 wt% sodium citrate and 0.75 mM sodium borohydride was 1:2:3, and the reaction condition was 0℃.

[0035] A hydrophilic film-forming component, a crosslinking agent, and ultra-small gold nanoparticles are dispersed in a first solvent system to form a first spinning precursor; the first solvent system is deionized water. (b) The hydrophobic film-forming group is dispersed in a second solvent system to form a second spinning precursor; the second solvent system is N,N-dimethyl sulfoxide; (c) The first spinning precursor is shaped into a fiber substrate layer by electric field driving technology, and the second spinning precursor is sequentially applied to the surface of the substrate layer to form an integral biphase fiber at the interface between the two phases. (d) A functional modification medium, namely an alkenyl compound, is applied to the outer surface of the biphasic fiber carrier by spray deposition technology to form a dressing pharmaceutical composition; (e) The obtained dressing drug composition is dried and placed in a cutting machine to obtain dressings of different specifications and shapes. The dressings are then combined with a backing layer, an adhesive layer and a protective layer and packaged to obtain the target product.

[0036] In a particular embodiment, the composite order of the functional layer, backing layer, adhesive layer, and protective layer from top to bottom is adhesive layer, functional layer, backing layer, and protective layer.

[0037] The first spinning precursor, the second spinning precursor, and the functional modification medium were placed in an electrospinning high-voltage electric field and spun into films with the parameters shown in Table 2, respectively obtaining hydrophilic film-forming components, hydrophobic film-forming components, and spray deposition components. The dosage of each reactant and process parameters are detailed in the table below.

[0038] Table 1. Preparation Formula of Wound Dressing Drug Composition

[0039]

[0040] Table 2. Process parameters for electrospinning / spraying of wound dressing drug compositions

[0041]

[0042] Comparative Example 1 The difference between this comparative example and Example 1 is that the loading of ultra-small gold nanoparticles in the first layer is 0% (v / v), and the injection volume of the alkenyl compound in the third layer is 0 mL, thus preparing a blank dressing without ultra-small gold nanoparticles and alkenyl compound. The preparation process is the same as in Example 8.

[0043] Comparative Example 2 The difference between this comparative example and Example 1 is that the loading of ultra-small gold nanoparticles in the first layer is 0% (v / v), meaning that a dressing containing only alkenyl compounds and no ultra-small gold nanoparticles is prepared. The preparation process is the same as in Example 8.

[0044] Comparative Example 3 The difference between this comparative example and Example 1 is that the injection volume of the alkenyl compound in the third layer is 0 mL, resulting in a dressing containing only ultra-small gold nanoparticles and no alkenyl compound. The preparation process is the same as in Example 8.

[0045] Comparative Example 4 The difference between this comparative example and Example 1 is that the loading of ultra-small gold nanoparticles in the first layer is 40% (v / v), and the injection volume of the alkenyl compound is 2 mL. The preparation process is the same as in Example 8.

[0046] Comparative Example 5 The difference between this comparative example and Example 1 is that the loading of ultra-small gold nanoparticles in the first layer is 1% (v / v), the injection volume of the alkenyl compound is 2 mL, and the preparation process is the same as in Example 8.

[0047] Comparative Example 6 The difference between this comparative example and Example 1 is that the preparation order of the dressing is changed. First, the third layer of alkenyl compound is electrosprayed; after this is completed, the first layer of ultra-small gold nanoparticles is loaded. The preparation process is the same as in Example 8.

[0048] Comparative Example 7 The difference between this comparative example and Example 1 is that no layered loading was performed. An equivalent amount of ultrasmall gold nanoparticles and an alkenyl compound were pre-mixed physically to form a homogeneous mixture, which was then loaded onto a dressing substrate in a single step. The preparation process was the same as in Example 8.

[0049] II. Properties of Wound Dressing Drug Compositions 1. Exudate absorption capacity of wound dressing drug compositions Using the formulations shown in Examples 1-7 and the method described in Example 8, a wound dressing drug composition was constructed for an exudate absorption performance study. A 2 cm × 2 cm section of the dressing was cut along its center, and the exudate absorption capacity of the dressing was studied by weighing. The dressing was dried at 50°C for 24 h, and the dry weight (W0) was recorded. It was then soaked in 50 mL of exudate mimic (SWF), and the SWF was perfected according to the standard EN 13726. 800 mL of deionized water was taken, and NaCl (110 mM), KCl (2.7 mM), MgCl2 (0.5 mM), KH2PO4 (1.3 mM), and NaHCO3 (20 mM) were added sequentially, and stirred until completely dissolved. Bovine serum albumin (BSA) was then added to a final concentration of 34 g / L, and gently stirred for 3-4 h to ensure complete dissolution of BSA. CaCl2 was dissolved in 100 mL of deionized water (2.2 mM) and then slowly added to the above solution. Finally, bring the total volume of the solution to 1 L with deionized water. After standing at room temperature for 2 h, remove the sample, filter the supernatant, hold the remaining sample with tweezers for 30 s to remove excess deionized water from the sample surface, then weigh it again and record the wet weight. The hygroscopic capacity is measured by the difference in weight before and after measurement. Each sample is tested three times.

[0050] The results are as follows Figure 1 As shown, the permeate absorption rate test results of each embodiment all exhibit excellent performance. Among them, the absorption rates of Examples 1, 3, and 4 all exceed 950%, and in particular, Examples 1 and 3 break through 1060%, representing the optimal effect of this technical solution. This data series verifies the significant progress of this patent in efficient liquid absorption and clearly reveals that product performance can be substantially improved by optimizing specific technical parameters.

[0051] 2. Water vapor permeability of wound dressing drug composition Using the formulations shown in Examples 1-7 and the method described in Example 8, a wound dressing drug composition was constructed for water vapor transmission rate study. A 2 cm × 2 cm section of the dressing was cut along the center and placed over a WVT bottle (13 mm in diameter) containing 10 mL of SWF. The dressing was then secured to the bottle opening with sealing film and rubber bands to prevent any water vapor loss through the boundary. The bottle was placed in a 37°C constant temperature and humidity chamber, where water vapor transmission rate was negligible. The weight of the WVT bottle (m1) was accurately measured, and the weight was recorded as m2 after 24 hours. The area of ​​the bottle opening was considered the water vapor transmission area and recorded as s, with units of g / m². 2 • 24 h. Ambient parameters: temperature 37℃, relative humidity 20%. Each sample was tested three times, and the average value was used as the WVTR of the fiber membrane. WVTR was calculated using the formula:

[0052] The results are as follows Figure 2 As shown, the water vapor transmission rate of all embodiments remained stable above 1500 g / m²·day, demonstrating excellent overall performance. Examples 2 (2006.05) and 1 (1903.79) constitute a high-performance range, particularly suitable for applications requiring extremely high gas exchange efficiency; Examples 3 (1859.08), 5 (1749.81), and 6 (1699.32) constitute a core range with concentrated and stable performance.

[0053] 3. AGEs binding capacity of wound dressing drug compositions Using the formulations shown in Examples 1-7 and Comparative Examples 1-7, and the method described in Example 8, a wound dressing drug composition was constructed for AGEs binding performance study. A 2 cm × 2 cm section of the dressing was cut along the center and fixed onto a vertical Franz diffusion cell system (TK-24BL, Shanghai Kaikai). The receiving cell was pre-filled with 14.0 mL of AGEs solution (1 mg / mL) (effective diffusion area 1.77 cm², receiving cell volume 14.0 mL). The mixture was magnetically stirred at 37°C (600 rpm) for 1 h. 0.25 mL of the receiving solution was precisely transferred, and 6 mL of PBS and 0.4 mL of DTNB were added. The mixture was reacted in the dark for 2 min, centrifuged (5000 × g, 10 min, 4°C), and the AGEs content in the test solution was measured using an ELISA reader. The AGEs binding rate was calculated.

[0054] The results are as follows Figure 3 As shown, the binding rate of AGEs in Examples 1 to 7 is consistently above 90%, indicating that within the core technical framework of this patent, even with appropriate adjustments and changes to the specific implementation conditions, the final product can maintain consistent and excellent performance in the key function of binding AGEs.

[0055] The binding rates of Comparative Example 2 (containing only alkenyl compounds) and Comparative Example 3 (containing only ultrasmall gold nanoparticles) (80.11 ± 1.71% and 8.28 ± 1.06%, respectively) showed some activity, but were significantly lower than those of Example 1 (96.59 ± 1.5%). This result clearly shows that the combination of ultrasmall gold nanoparticles and alkenyl compounds in the structure of the present invention produces a synergistic effect, with the final binding performance far exceeding that of any single component, achieving a more efficient and stable therapeutic effect. The binding rates of Comparative Example 4 and Comparative Example 5 (with gold nanoparticle loadings of 40% and 1%, respectively) (85.72 ± 1.98% and 69.09 ± 2.17%) failed to reach the optimal level of Example 1. This proves that the loading amount determined in Example 1 is a narrow and optimized window for achieving this synergistic effect.

[0056] Finally, the binding rates of Comparative Example 6 (with altered electrospinning sequence) and Comparative Example 7 (using physical mixing) dropped sharply to approximately 12.22 ± 2.06% and 9.53 ± 2.11%, respectively, almost losing their effective binding capacity. This confirms that the specific layered preparation sequence used in this invention is a key step in constructing the special structure capable of producing the aforementioned synergistic effect.

[0057] In summary, the technical solution of Example 1 demonstrates statistically significantly superior binding performance in direct comparisons with all comparative examples. This superior performance stems from the clear pharmacodynamic synergy between components, the precise optimization of key parameters, and the accurate construction of the active structure through a unique process. All three are indispensable and together constitute the inventive core that distinguishes this invention from existing technologies.

[0058] 4. In vitro release study of the drug composition for wound dressings Using the formulations shown in Examples 1-7 above, and the method described in Example 8, a wound dressing drug composition was constructed for in vitro release. A 2 cm × 2 cm section of the dressing was cut along the center and vertically fixed onto a Franz diffusion cell system (TK-24BL, Shanghai Kaikai). The receiving cell was pre-filled with 14.0 mL of SWF, and the drug was released by stirring at a constant temperature of 37°C for 24 h. At preset time points of 1, 2, 4, 8, 12, and 24 h, 2 mL samples were taken and an equal volume of SWF was immediately added. Immediately after sampling, the content of ultra-small gold nanoparticles was measured using a UV spectrophotometer, and the cumulative release rate was calculated.

[0059] The results are as follows Figure 4 As shown, the in vitro release characteristics of the seven embodiments prepared according to the technical solution of this patent within 24 hours are illustrated. All embodiments achieved rapid onset of action within 1 hour, followed by a smooth transition in release rate, with continuous release within 4 to 8 hours, and finally achieving a high cumulative release rate of over 90% within 24 hours, indicating that the active ingredient was fully utilized.

[0060] 5. Investigation of the antibacterial properties of the wound dressing drug composition Using the formulations shown in Examples 1-7 and Comparative Examples 1-7, and the method described in Example 8, a wound dressing drug composition was constructed for antibacterial performance evaluation. Staphylococcus aureus (Staphylococcus aureus) was used as the control. S. aureus ATCC 25923 ) and Escherichia coli ( E. coli ATCC 25922 To prepare the test bacteria, cut a 2 cm × 2 cm piece from the center of the dressing and mix it with 15 mL of [unclear - possibly a specific solution]. S. aureus or E. coli Bacterial suspension (1×10) 6 The cultures (CFU / mL) were co-cultured in LB broth at 35°C for 24 h. After culturing, each culture was diluted 10⁻⁶. 5 Take 50 μL of the diluted bacterial solution and spread it evenly on an agar plate. Place the plate in a 35°C incubator and incubate with shaking at 90 rpm for 24 h. After incubation, count the colony-forming units on the agar plate and calculate the inhibition rate.

[0061] Table 1. Results of in vitro antibacterial performance testing of wound dressing drug compositions

[0062] The results showed that Example 1 exhibited near-complete inhibitory effects against both Staphylococcus aureus (99.35%) and Escherichia coli (99.78%). Compared to all comparative examples, its comprehensive and significant superiority was demonstrated on three levels: First, compared to the almost ineffective comparative examples 1 and 2 (inhibition rate <0.2%) and the significantly ineffective comparative examples 5 and 7 (15-67%), Example 1 achieved an order-of-magnitude performance leap; second, even compared to the better-performing comparative examples 3, 4, and 6 (87-91%), Example 1 maintained an inhibition rate close to 100% against both strains, proving its superior broad-spectrum activity and potency. The combination of key components under the specific formulation and process of this invention produced an antibacterial effect far exceeding that of a single component or conventional combinations, achieving highly efficient and balanced inhibition of both Gram-positive and Gram-negative bacteria, indicating that it may act synergistically through multiple mechanisms.

[0063] 6. Pharmacodynamic evaluation of wound dressing drug compositions This experiment was divided into 5 groups: (1) blank group, (2) blank dressing group, (3) dressing group containing only ultra-small gold nanoparticles of Comparative Example 3, (4) dressing group containing only alkenyl compounds of Comparative Example 2, and (5) dressing drug composition group of Example 1.

[0064] The treatment groups were divided into five categories: (1) a blank group, which received no treatment; (2) a blank dressing group, which received treatment with a blank dressing containing no active substances; (3) a dressing group containing only ultra-small gold nanoparticles, which received treatment with a dressing containing only ultra-small gold nanoparticles; (4) a dressing group containing only alkenyl compounds, which received treatment with a dressing containing only alkenyl compounds; and (5) a dressing drug composition group, which contained both ultra-small gold nanoparticles and alkenyl compounds, and the wound healing ability of the dressing drug composition was evaluated. All groups were given medication daily for 14 days.

[0065] 6.1 Investigation of wound healing rate Mice with diabetic ulcers infected with Staphylococcus aureus were used as a model for in vivo pharmacodynamic evaluation to investigate the effect of the dressing composition on infected diabetic ulcer wounds. Figure 5As shown in Figure A, in the control group, the healing of diabetic ulcer wounds was severely delayed. On days 3 and 7, varying degrees of bacterial infection appeared in the control group, the blank dressing group, and the dressing group containing only alkenyl groups. However, no bacterial infection was observed in the two groups containing ultra-small gold nanoparticles, indicating that the dressing has good antibacterial effects. Furthermore, the nanoscale nature of the dressing also prevented bacterial invasion to some extent, avoiding wound infection and accelerating healing. On day 14, significant scab formation appeared in the control group and the blank dressing group. The medicated dressing, however, exhibited good water retention properties, maintaining a certain level of moisture at the wound site and creating an environment conducive to healing. Figure 5 As shown in Figure B, on day 14, the average wound area recovery rates were 84.43% and 92.40% for the dressing group containing only ultra-small gold nanoparticles and the dressing group containing only alkenyl compounds, respectively. However, when a dressing containing both ultra-small gold nanoparticles and alkenyl compounds was used in combination, the wound healing rate increased to 99.17%, significantly higher than the other groups. These results indicate that the dressing-medicated composition is an ideal treatment for the healing of diabetic ulcers, producing satisfactory therapeutic effects.

[0066] 6.2 Determination of AGEs content The content of AGEs in the wound was assessed using an ELISA kit on days 0, 7, and 14, respectively. Figure 6 As shown, on day 0, the AGEs content in the wounds of all groups was at a high level. After 7 days of treatment, the dressing group containing only ultra-small gold nanoparticles and the dressing group containing only alkenyl compounds reduced the AGEs content to 4.7 and 3.8 μg / mL, respectively. When the treatment period was extended to 14 days, the present invention showed significantly better results, with the wound AGEs content decreasing to 0.78 μg / mL, significantly lower than any single-component treatment group. The above differences between groups fully demonstrate that ultra-small gold nanoparticles and alkenyl compounds, in the specific combination and structure provided by the present invention, can produce a synergistic effect, jointly promoting the effective clearance of AGEs in the wound.

[0067] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A dressing composition for wound care, characterized in that, The dressing pharmaceutical composition is a topical patch, comprising a functional layer consisting of a polymer base layer and a functional modification layer. composition: The first layer includes a hydrophilic film-forming component, which comprises a hydrophilic polymer, a crosslinking agent, and ultra-small gold nanoparticles, wherein the ultra-small gold nanoparticles refer to gold nanoparticles with a particle size ≤ 5 nm. The second layer includes a hydrophobic film-forming component, wherein the hydrophobic film-forming component includes a hydrophobic polymer; The first and second layers constitute the polymer base layer; The third layer is the functional modification layer, which contains alkenyl compounds.

2. The dressing pharmaceutical composition according to claim 1, characterized in that, The dressing pharmaceutical composition further includes one or more of a backing layer, an adhesive layer, and a protective layer.

3. The dressing pharmaceutical composition according to claim 1, characterized in that, The hydrophilic polymer is selected from one or more of polyvinyl alcohol, cellulose and its derivatives, chitosan, polyvinylpyrrolidone, gelatin, and sodium alginate with different degrees of alcoholysis. The crosslinking agent is selected from one or more of glutaraldehyde, glycerol, genipin, maleic anhydride, citric acid, or diisocyanate; Preferably, the weight percentage of the hydrophilic polymer to the crosslinking agent is 0.4:1 to 20:1; the weight percentage of the ultrasmall gold nanoparticles to the hydrophilic polymer to the crosslinking agent is 1:5.4:13.6 to 9:20:

1.

4. The dressing pharmaceutical composition according to claim 1, characterized in that, The hydrophobic polymer is selected from one or more of polyurethane, polystyrene, polyvinylidene fluoride, polytetrafluoroethylene, ethyl cellulose, polycaprolactone, or polymethylhydrosiloxane. Preferably, the mass ratio of the hydrophobic polymer to the hydrophilic polymer is 1:

6.

5. The dressing pharmaceutical composition according to claim 1, characterized in that, The alkenyl compound is selected from one or more of 6-maleimide hexanoic acid, vinylpyridine, polyethylene glycol-vinyl sulfone, and acrylonitrile, and the mass ratio of the alkenyl compound to the ultra-small gold nanoparticles is 1:90 to 3:

5.

6. The dressing pharmaceutical composition according to claim 1, characterized in that, The first layer has a thickness of 60 ± 2 μm, the second layer has a thickness of 48 ± 3 μm, and the third layer has a spray density of 1.75 ~ 3.0 mg / cm³. 2 .

7. A method for preparing the dressing pharmaceutical composition according to any one of claims 1 to 6, characterized in that, The polymer base layer and the functional modification layer are integrally formed by electrospinning or spray deposition technology, specifically including: (a) 1 wt% tetrachloroauric acid, 1 wt% sodium citrate, and 0.75 mM sodium borohydride were reacted at 0 °C in a volume ratio of 1:2:

3. After centrifugation and filtration, ultra-small gold nanoparticles were obtained. A hydrophilic film-forming polymer, a crosslinking agent, and ultra-small gold nanoparticles are dispersed in a first solvent system, which is deionized water, to form a first spinning precursor. (b) Dispersing the hydrophobic polymer in a second solvent system, wherein the second solvent system is N,N-dimethyl sulfoxide, to form a second spinning precursor; (c) The first spinning precursor is shaped into a fiber substrate layer by electric field driving technology, and the second spinning precursor is sequentially applied to the surface of the substrate layer to form an integral biphase fiber at the interface between the two phases. (d) A functional modification layer is applied to the outer surface of the biphasic fiber carrier by spray deposition technology to form a dressing pharmaceutical composition; (e) The obtained dressing composition is dried and placed in a cutting machine to obtain a functional layer of the dressing composition. The functional layer is combined with one or more of a backing layer, an adhesive layer, and a protective layer to obtain the dressing composition.

8. The preparation method according to claim 7, characterized in that, The concentration of the hydrophilic polymer in the first spinning precursor is 5% to 20 wt%, the loading of the ultra-small gold nanoparticles is 5 to 30 v / v, the concentration of the hydrophobic polymer in the second spinning precursor is 10% to 30 wt%, and the concentration of the alkenyl compound in the functional modification layer is 0.5% to 3% wt.

9. The preparation method according to claim 7, characterized in that, (c) The parameters for electrospinning of the first spinning precursor solution are: voltage 10 ~ 30 kV, receiving distance 5 ~ 20 cm, feed rate 2.25 ~ 5.22 mL / h, humidity 30% ~ 60%, and temperature 20 ~ 70℃. Electrospinning parameters for the second spinning precursor solution: voltage 5 ~ 20 kV, receiving distance 8 ~ 30 cm, feed rate 0.75 ~ 2.25 mL / h, humidity 30% ~ 60%, temperature 20 ~ 70℃; (d) Spraying parameters for the functional modification layer: voltage 15 ~ 30 kV, receiving distance 5 ~ 20 cm, propulsion speed 0.15 ~ 1.5 mL / h, humidity 30% ~ 60%, and temperature 20 ~ 70℃.

10. The use of the dressing pharmaceutical composition of any one of claims 1 to 6 in the preparation of a wound dressing pharmaceutical for inhibiting and / or clearing wound pathological products, preferably, the pathological products being AGEs.

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