Nursing medicine composition for preventing pressure sores and preparation method thereof

Abstract

The invention provides a nursing pharmaceutical composition for preventing pressure sores and a preparation method thereof, and the composition is composed of an active component, a liquid absorption component and pharmaceutically acceptable auxiliary materials, active components of the composition comprise an astragalus extract, an angelica sinensis extract, a lithospermum extract, a recombinant human epidermal growth factor, pentoxifylline, polyhexamethylene biguanide hydrochloride, beta-glucan, asiaticoside and magnolol, and the effects of improving microcirculation, resisting inflammation and bacteria and promoting tissue repair are comprehensively achieved through a multi-target synergistic effect; luminan microspheres or calcium alginate fibers are adopted as liquid absorption components, wound exudate is effectively managed, a wet environment is maintained, a split-phase preparation and low-temperature integration process is adopted in the preparation method, the compatibility problem of complex components is solved, and the stability and effectiveness of the product are ensured; the device integrates active treatment and protection, is suitable for preventing and treating pressure sores in all stages, and has the advantages of being remarkable in effect and safe to use.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a pressure ulcer prevention and care pharmaceutical composition and its preparation method. Background Technology

[0002] Pressure ulcers, also known as pressure injuries, are a common clinical condition caused by prolonged pressure on local tissues, leading to impaired blood circulation and resulting in persistent ischemia, hypoxia, and malnutrition of the skin and subcutaneous tissues, ultimately causing soft tissue ulceration and necrosis. They are commonly seen in patients who are bedridden for extended periods, have spinal cord injuries, are elderly or frail, are emaciated, or are severely ill. Pressure ulcers not only cause immense suffering, prolong hospital stays, and increase medical costs, but in severe cases, they can also lead to secondary infections, sepsis, and even death.

[0003] Currently, the clinical nursing and treatment of pressure ulcers mainly follows the principle of prevention first, combined with treatment. Methods include regular turning to relieve pressure, using physical measures such as pressure-relieving mattresses, and topical medication. However, there are still many shortcomings in topical medication that urgently need to be addressed:

[0004] Currently, clinically used pressure ulcer prevention preparations are mainly divided into three categories: First, single-herb extract preparations, which, although possessing anti-inflammatory or moisturizing effects, have a slow wound repair rate and lack targeted antibacterial effects, making them difficult to deal with mixed pathogenic bacterial infections; second, chemically synthesized antibacterial agents (such as silver sulfadiazine cream), which have a narrow antibacterial spectrum and limited inhibitory effects on drug-resistant pathogens such as Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus (MRSA), and long-term use can easily lead to skin irritation and drug resistance; third, single-bioactive ingredient preparations (such as recombinant human epidermal growth factor gel), which, although able to promote cell proliferation, lack the synergistic effects of skin barrier repair and microcirculation improvement, and are easily affected by wound exudate dilution, resulting in rapid attenuation of effects.

[0005] Pressure ulcers, especially grade II and above, are often accompanied by a large amount of exudate. If the exudate accumulates, it will lead to a moist wound, bacterial growth, increased risk of infection, and delayed healing. Existing formulations generally lack targeted absorbent design: creams and ordinary gels have weak absorbent capacity and easily mix with exudate to form a paste-like contaminant, requiring frequent replacement; some formulations containing absorbent components can absorb fluid, but their incompatibility with drug ingredients is poor, easily leading to loss of active ingredients, and they cannot achieve integrated absorption, moisturizing, and repair. At the same time, the selection and process adaptability of existing absorbent components are insufficient. For example, microsphere absorbent components are prone to agglomeration in formulations, and fibrous components are easily structurally damaged by the manufacturing process, resulting in unstable absorbent efficiency and difficulty in meeting the clinical need for precise control of the moist wound environment.

[0006] Recombinant human epidermal growth factor (rhEGF) and other bioactive components are crucial for promoting wound healing; however, these components are heat-sensitive and easily inactivated by acids, alkalis, and shear forces. Existing preparation processes have significant drawbacks: first, they fail to differentiate the solubility characteristics of water-soluble and lipid-soluble components, employing direct mixing methods that lead to uneven dispersion of some components, affecting efficacy; second, gel matrix preparation often uses room-temperature swelling, causing premature hydration and clumping of matrices such as carbomer, resulting in uneven formulation texture; and third, the lack of low-temperature protection processes leads to excessively high activity loss rates of rhEGF and other active components during high-temperature emulsification and stirring. Furthermore, existing processes lack sufficient control over emulsification homogenization, resulting in inadequate fusion of the oil and aqueous phases, leading to layering and precipitation during storage, uneven distribution of active components, and further impacting the stability of clinical efficacy.

[0007] Therefore, existing technologies mostly focus on a single function: preventive agents mainly moisturize and reduce pressure, lacking antibacterial and repair effects; therapeutic agents mainly promote healing and inhibit bacteria, neglecting the repair and protection of the skin barrier after healing, resulting in a high recurrence rate of pressure ulcers. Summary of the Invention

[0008] In view of this, the present invention proposes a pressure ulcer prevention and care drug composition, a preparation method thereof, and a preparation method thereof, to solve the above problems.

[0009] The technical solution of the present invention is achieved as follows: a pressure ulcer care pharmaceutical composition comprising an active ingredient, an absorbent component, and pharmaceutically acceptable excipients, wherein the active ingredient comprises, by weight, 5-15 parts of Astragalus membranaceus extract, 3-10 parts of Angelica sinensis extract, 2-8 parts of Lithospermum erythrorhizon extract, 0.001-0.01 parts of recombinant human epidermal growth factor, 0.05-0.3 parts of pentoxifylline, 0.1-0.5 parts of polyhexamethylene biguanide hydrochloride, 1-5 parts of β-glucan, 1.5-6 parts of total glycosides of Centella asiatica, and 0.5-2 parts of magnolol; the excipients comprise absorbents, humectants, penetration enhancers, antibacterial agents, and a matrix.

[0010] Preferably, the active ingredients, by weight, include: 10 parts Astragalus membranaceus extract, 7 parts Angelica sinensis extract, 5 parts Lithospermum erythrorhizon extract, 0.005 parts recombinant human epidermal growth factor, 0.15 parts pentoxifylline, 0.3 parts polyhexamethylene biguanide hydrochloride, 3 parts β-glucan, 3 parts total asiaticosides, and 1 part magnolol.

[0011] Preferably, the mass ratio of the active ingredient, the liquid-absorbing component, and the pharmaceutically acceptable excipient is (25-30):(0.5-5):50.

[0012] Preferably, the β-glucan is oat-derived β-glucan with a molecular weight of 50,000-150,000 Da and a purity of ≥90%.

[0013] Preferably, the liquid-absorbing component is a sclerosing polysaccharide microsphere or calcium alginate fiber, wherein the particle size of the sclerosing polysaccharide microsphere is in the range of 10-200 μm, and the length of the calcium alginate fiber is 0.5-5 mm.

[0014] Preferably, the excipients include, by weight: 5-20 parts of humectant, 0.5-3 parts of penetration enhancer, 0.1-0.8 parts of antibacterial agent, and 30-60 parts of matrix.

[0015] Preferably, the moisturizer is a mixture of glycerin and sodium hyaluronate in a weight ratio of 15-20:1, the penetration enhancer is a compound of azone and menthol in a weight ratio of 1:0.3-0.8, the antibacterial agent is ethylparaben, and the matrix is ​​a mixture of carbomer and propylene glycol in a weight ratio of 1:8-10.

[0016] Preferably, the method for preparing the pressure ulcer care pharmaceutical composition includes the following steps:

[0017] (1) Phase separation preparation:

[0018] (1a) Preparation of hydrogel phase: The matrix is ​​slowly added to 1-3 times the volume of purified water under high-speed shearing at 8000-10000 rpm, sheared for 5-10 minutes to disperse it evenly, and then allowed to stand at 2-8℃ for 12-24 hours to swell, so as to obtain a transparent hydrogel matrix.

[0019] (1b) Preparation of active ingredient oil phase: The penetration enhancer, antibacterial agent, pentoxifylline, polyhexamethylene biguanide hydrochloride and magnolol are mixed and stirred at 40-45℃ to completely dissolve to obtain the oil phase;

[0020] (1c) Preparation of water-soluble component solution: Astragalus extract, Angelica extract, Lithospermum extract, β-glucan, and total glycosides of Centella asiatica are dissolved in 1-3 times the volume of purified water to obtain water-soluble component solution;

[0021] (2) Primary emulsification and homogenization: Under stirring at 200-400 rpm, the oil phase obtained in step (1b) is slowly added to the water-soluble component solution obtained in step (1c). After the addition is complete, the stirring speed is increased to 800-1000 rpm and stirring is continued for 15-20 minutes to obtain a primary emulsion. Then, the primary emulsion is subjected to high-pressure homogenization and cycling at 15-20 MPa for 2-3 times.

[0022] (3) Low-temperature gelation: The primary emulsion obtained in step (2) is slowly added to the cold hydrogel base obtained in step (1a) and stirred until uniform;

[0023] (4) Integration of components:

[0024] (4a) Add the liquid-absorbing component to the mixture obtained in step (3) and stir at low speed for 5-10 minutes to disperse it evenly;

[0025] (4b) Dissolve the recombinant human epidermal growth factor in 5-10 parts by weight of sterile water for injection at a temperature of 2-8°C, and then slowly add it to the system under very low stirring at 50-100 rpm.

[0026] (5) Post-processing and shaping: Add a humectant to the system obtained in step (4), adjust the pH value of the system to 6.0-6.5 with a pH adjuster, filter it under sterile conditions through a 0.22μm microporous membrane, and fill it.

[0027] Preferably, in step (1a), the temperature of the purified water is 4-10°C. This low temperature condition can effectively inhibit premature hydration and agglomeration of carbomer during dispersion, ensuring uniform texture of the base material.

[0028] In step (3), the temperature of the mixing system is controlled to be below 15°C. This low temperature condition can maintain the carbomer gel base material in a low viscosity state, ensure uniform mixing with the primary emulsion, and avoid uneven dispersion of components caused by local gelation.

[0029] In step (4a), the low-speed stirring speed is 100-200 rpm, and the stirring paddle is anchor or frame type. This specific condition can minimize damage to the spherical shape or fiber length of the microspheres while dispersing the liquid-absorbing components.

[0030] The use of pressure ulcer care pharmaceutical compositions in the preparation of medical devices or pharmaceutical products for the prevention and / or treatment of pressure ulcers.

[0031] Compared with the prior art, the beneficial effects of the present invention are:

[0032] This invention's composition achieves significant therapeutic effects through the synergistic effect of multiple components. Pentoxoxothecoside improves microcirculation, magnolol and polyhexamethylene biguanide hydrochloride synergistically combat inflammation and bacteria, recombinant human epidermal growth factor and extracts of traditional Chinese medicines such as Astragalus and Angelica sinensis promote tissue repair, and β-glucan enhances immune regulation, forming a multi-target therapeutic system. The dosage form design utilizes intelligent absorbent components such as glucan microspheres to manage wound exudate, combined with a temperature-sensitive hydrogel matrix to provide physical buffering and achieve sustained drug release. In vitro experiments show an absorption rate increase of more than 3 times. In terms of preparation technology, phase separation and low-temperature integration techniques are employed. By first emulsifying and encapsulating the active ingredients, and then mixing them with the gel matrix at low temperature (<15°C), the compatibility of components is effectively solved, ensuring product stability. Animal experiments show that this invention's composition increases the wound healing rate to 98.5%, and the granulation tissue score reaches 4.5 out of 5, significantly better than the control group. This invention integrates active treatment and protection, overcoming the shortcomings of traditional products with limited functionality, and providing an innovative solution for pressure ulcer prevention and treatment. Detailed Implementation

[0033] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0034] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0035] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0036] The embodiments and comparative examples of this invention underwent skin irritation tests and showed no irritation or allergic reactions.

[0037] In this invention, Astragalus extract is prepared by water extraction and alcohol precipitation: take Astragalus medicinal material, add 10 times the volume of water, extract at 70°C for 3 hours, filter and concentrate the extract, add ethanol until the alcohol concentration of the system reaches 80%, let stand for 20 hours, filter and dry under reduced pressure to obtain Astragalus extract.

[0038] Angelica sinensis extract is prepared by pulverizing Angelica sinensis into 30 mesh, adding 12 times the amount of 60% v / v ethanol aqueous solution, refluxing at 60℃ twice for 2 hours each time, combining the extracts, purifying through macroporous adsorption resin, and then drying under reduced pressure.

[0039] The extract of Lithospermum erythrorhizon is prepared by pulverizing Lithospermum erythrorhizon into 40 mesh, adding 10 times the amount of 70% v / v ethanol, adding 0.2% of vitamin C by weight of the medicinal material as an antioxidant, and extracting twice at a constant temperature of 55℃ with stirring, each time for 1 hour. After filtration, it is decolorized with diatomaceous earth, purified by extraction with ethyl acetate, and dried after solvent recovery under reduced pressure.

[0040] Example 1

[0041] Pressure ulcer care composition: The mass ratio of active ingredient, absorbent component and pharmaceutically acceptable excipients is 25:0.5:50;

[0042] Active ingredients: Astragalus membranaceus extract 5 parts, Angelica sinensis extract 3 parts, Lithospermum erythrorhizon extract 2 parts, recombinant human epidermal growth factor 0.001 parts, pentoxifylline 0.05 parts, polyhexamethylene biguanide hydrochloride 0.1 parts, β-glucan 1 part, total glycosides of Centella asiatica 1.5 parts, magnolol 0.5 parts;

[0043] Liquid-absorbing component: Brilliant polysaccharide microspheres (particle size 50-100μm);

[0044] Pharmaceutically acceptable excipients:

[0045] Moisturizer 5 parts: glycerin and sodium hyaluronate in a weight ratio of 15:1;

[0046] Penetration enhancer 0.5 parts: azone and menthol in a weight ratio of 1:0.3;

[0047] 0.1 parts of antibacterial agent: ethylparaben;

[0048] 30 parts matrix: Carbomer and propylene glycol in a weight ratio of 1:8.

[0049] Example 2

[0050] Pressure ulcer care composition: The mass ratio of active ingredient, absorbent component and pharmaceutically acceptable excipient is 30:5:50;

[0051] Active ingredients: Astragalus membranaceus extract 15 parts, Angelica sinensis extract 10 parts, Lithospermum erythrorhizon extract 8 parts, recombinant human epidermal growth factor 0.01 parts, pentoxifylline 0.3 parts, polyhexamethylene biguanide hydrochloride 0.5 parts, β-glucan 5 parts, total glycosides of Centella asiatica 6 parts, magnolol 2 parts;

[0052] Liquid-absorbing component: Brilliant polysaccharide microspheres (particle size 50-100μm);

[0053] Pharmaceutically acceptable excipients:

[0054] Moisturizer 20 parts: Glycerin and sodium hyaluronate in a weight ratio of 20:1;

[0055] Three parts of penetration enhancer: azone and menthol in a weight ratio of 1:0.8;

[0056] 0.8 parts of antibacterial agent: ethylparaben;

[0057] 60 parts matrix: Carbomer and propylene glycol in a weight ratio of 1:10.

[0058] Example 3

[0059] Pressure ulcer care composition: The mass ratio of active ingredient, absorbent component and pharmaceutically acceptable excipients is 28:2:50;

[0060] Active ingredients: 10 parts Astragalus membranaceus extract, 7 parts Angelica sinensis extract, 5 parts Lithospermum erythrorhizon extract, 0.005 parts recombinant human epidermal growth factor, 0.15 parts pentoxifylline, 0.3 parts polyhexamethylene biguanide hydrochloride, 3 parts β-glucan, 3 parts total glycosides of Centella asiatica, and 1 part magnolol;

[0061] Liquid-absorbing component: Brilliant polysaccharide microspheres (particle size 50-100μm);

[0062] Pharmaceutically acceptable excipients:

[0063] Moisturizer 15 parts: glycerin and sodium hyaluronate in a weight ratio of 18:1;

[0064] 1.5 parts of penetration enhancer: azone and menthol in a weight ratio of 1:0.5;

[0065] 0.5 parts of antibacterial agent: ethylparaben;

[0066] 50 parts matrix: Carbomer and propylene glycol in a weight ratio of 1:9.

[0067] The above Examples 1-3 were prepared using the following methods:

[0068] (1) Phase separation preparation:

[0069] (1a) Preparation of hydrogel phase: The matrix was slowly added to 2 times the volume of purified water at 6°C under high-speed shearing at 10000 rpm, and sheared for 8 minutes to make it uniformly dispersed. Then it was allowed to stand at 5°C for 20 hours to swell, and a transparent hydrogel matrix was obtained.

[0070] (1b) Preparation of the active ingredient oil phase: The penetration enhancer, antibacterial agent, pentoxifylline, polyhexamethylene biguanide hydrochloride, and magnolol were mixed and stirred at 42°C until completely dissolved to obtain the oil phase;

[0071] (1c) Preparation of water-soluble component solution: Astragalus extract, Angelica extract, Lithospermum extract, β-glucan, and total glycosides of Centella asiatica were dissolved in 2 volumes of purified water to obtain water-soluble component solution;

[0072] (2) Primary emulsification and homogenization: Under stirring at 300 rpm, the oil phase obtained in step (1b) is slowly added to the water-soluble component solution obtained in step (1c). After the addition is complete, the stirring speed is increased to 1000 rpm and stirring is continued for 18 minutes to obtain a primary emulsion. Then, the primary emulsion is subjected to high-pressure homogenization cycle at 18 MPa for 3 times.

[0073] (3) Low-temperature gelation: The primary emulsion obtained in step (2) is slowly added to the cold water gel base obtained in step (1a), and the temperature of the mixing system is controlled to be below 15°C. The mixture is stirred and mixed evenly.

[0074] (4) Integration of components:

[0075] (4a) Add the liquid-absorbing component to the mixture obtained in step (3) and stir at a low speed of 150 rpm for 8 minutes to disperse it evenly;

[0076] (4b) After dissolving the recombinant human epidermal growth factor in 8 parts by weight of sterile water for injection at 5°C, it was slowly added to the system under very low stirring at 80 rpm.

[0077] (5) Post-processing and shaping: Add a humectant to the system obtained in step (4), adjust the pH value of the system to 6.5 with a pH adjuster, filter it under sterile conditions through a 0.22μm microporous membrane, and fill it.

[0078] Comparative Example 1

[0079] The difference between this comparative example and Example 3 is that the formulation does not contain pentoxifylline or magnolol, which are supplemented with purified water, and the preparation method is the same as that in Example 3.

[0080] Comparative Example 2

[0081] The difference between this comparative example and Example 3 is that the formulation does not contain β-glucan or total asiaticosides, which are supplemented with purified water, and the preparation method is the same as that of Example 3.

[0082] Comparative Example 3

[0083] The difference between this comparative example and Example 3 is that the formulation does not contain any liquid-absorbing components, which are supplemented by purified water, and the preparation method omits step (4a), that is, the post-processing is carried out directly after the addition of growth factors.

[0084] Comparative Example 4

[0085] The difference between this comparative example and Example 3 is that the temperature of the purified water in step (1a) of the preparation method is 25°C, the swelling temperature is 25°C, and the temperature of the mixing system in step (3) is 25°C. The rest is the same as Example 3.

[0086] Comparative Example 5

[0087] The difference between this comparative example and Example 3 is that the high-pressure homogenization step in step (2) is omitted in the preparation method, while the rest is the same as Example 3.

[0088] Effect test

[0089] I. Wound Healing Efficacy Test

[0090] 1. Test subjects: SPF grade SD rats (weight 200-220g) were used to construct a superficial grade II pressure ulcer model (using the stainless steel plate ± weight compression method, with a wound diameter of 1.5cm), with 10 rats in each group.

[0091] 2. Test method: Apply the sample once daily (dose 0.2g / cm). 2 Positive control group (commercial silver sulfadiazine cream) and model control group (no treatment) were included. The wound healing time (number of days required for complete epithelialization of the wound) was recorded, and the wound healing rate was calculated 7 days after the operation.

[0092] Healing rate = (initial area - area after 7 days) / initial area × 100%).

[0093] 3. Evaluation indicators: wound healing time and 7-day wound healing rate.

[0094] 4. At the end of the experiment, wound tissue was taken and HE staining was performed to observe the infiltration of inflammatory cells, growth of granulation tissue, epithelial regeneration, etc., and a semi-quantitative score was performed.

[0095]

[0096] 5. Test Results

[0097]

[0098] Example 3 was significantly superior to all comparative and positive control groups in all indicators (p<0.01). This comprehensively demonstrates: 1) the synergistic effect of the complete formulation; 2) the key influence of the absorbent components on the healing environment; and 3) the decisive role of optimized preparation process in ensuring the efficacy of the final product.

[0099] II. In vitro antibacterial activity test

[0100] 1. Test strains: methicillin-resistant Staphylococcus aureus (MRSA), Escherichia coli (ATCC25922), and Pseudomonas aeruginosa (ATCC27853).

[0101] 2. Test method: The paper disc diffusion method was used. A sterile filter paper disc (6 mm in diameter) containing the sample was attached to the culture medium of the inoculated strain and incubated at 37°C for 24 hours. The diameter of the inhibition zone (mm) was then measured.

[0102] 3. Test Results

[0103]

[0104] Example 3 showed the strongest antibacterial activity. Comparative Example 1, lacking acetone and magnolol, exhibited significantly weakened antibacterial activity, demonstrating their synergistic antibacterial effect. The process modification in Comparative Example 4 resulted in decreased antibacterial activity, indicating that the process affects the effectiveness of the components.

[0105] III. Leakage Absorption Capacity Test

[0106] 1. Test samples: Take 1g (W1) of each of the samples from Example 3 and Comparative Example 3 and spread them evenly in a sterile petri dish with a diameter of 3cm.

[0107] 2. Test Method: Simulated wound exudate (containing physiological saline, albumin, and simulated red blood cell solution, viscosity 15 mPa·s) was dropped onto the sample surface. After incubation at 37°C for a certain period, the sample was weighed (W2). The absorbance rate per unit mass of sample was calculated as follows: Absorption rate (g / g) = (W2 - W 1) / W1.

[0108] 3. Evaluation index: aspiration rate.

[0109] 4. Test Results

[0110]

[0111] Example 3 showed significantly better liquid absorption capacity than Comparative Example 3 (p<0.001), demonstrating that the leucogran microspheres can effectively absorb and lock in a large amount of exudate.

[0112] IV. Formulation Stability Testing

[0113] 1. Centrifugation stability: Place the sample in a centrifuge tube and centrifuge at 3000 rpm for 15 minutes. Observe whether it separates into layers or agglomerates, and calculate the separation rate (separation rate = layer volume / total sample volume × 100%).

[0114] 2. Accelerated stability: Store at 40℃ and RH75% for 6 months, observe the appearance (color, uniformity), measure the viscosity (25℃, rotational viscometer), and record the viscosity change rate (viscosity change rate = (initial viscosity - viscosity after 6 months) / initial viscosity × 100%).

[0115] 3. Evaluation indicators: centrifugal stratification rate, appearance after 6 months, and viscosity change rate.

[0116] 4. Test Results

[0117]

[0118] This invention demonstrates that high-pressure homogenization can fully integrate the oil and water phases, ensuring uniform dispersion of active ingredients and preventing stratification and aggregation during formulation storage.

[0119] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pressure ulcer care pharmaceutical composition, characterized in that, The product comprises active ingredients, absorbent components, and pharmaceutically acceptable excipients. The active ingredients, by weight, include: 5-15 parts Astragalus membranaceus extract, 3-10 parts Angelica sinensis extract, 2-8 parts Lithospermum erythrorhizon extract, 0.001-0.01 parts recombinant human epidermal growth factor, 0.05-0.3 parts pentoxifylline, 0.1-0.5 parts polyhexamethylene biguanide hydrochloride, 1-5 parts β-glucan, 1.5-6 parts total glycosides of Centella asiatica, and 0.5-2 parts magnolol. The excipients include absorbents, humectants, penetration enhancers, antibacterial agents, and a matrix.

2. The pressure ulcer care composition as described in claim 1, characterized in that, The active ingredients, by weight, include: 10 parts Astragalus membranaceus extract, 7 parts Angelica sinensis extract, 5 parts Lithospermum erythrorhizon extract, 0.005 parts recombinant human epidermal growth factor, 0.15 parts pentoxifylline, 0.3 parts polyhexamethylene biguanide hydrochloride, 3 parts β-glucan, 3 parts total glycosides of Centella asiatica, and 1 part magnolol.

3. The pressure ulcer care composition as described in claim 1, characterized in that, The mass ratio of the active ingredient, the liquid-absorbing component, and the pharmaceutically acceptable excipient is (25-30):(0.5-5):

50.

4. The pressure ulcer care composition as described in claim 1, characterized in that, The β-glucan is oat-derived β-glucan with a molecular weight of 50,000-150,000 Da and a purity of ≥90%.

5. The pressure ulcer care composition as described in claim 1, characterized in that, The liquid-absorbing component is a sclerosing polysaccharide microsphere or calcium alginate fiber, wherein the particle size of the sclerosing polysaccharide microsphere is in the range of 10-200 μm, and the length of the calcium alginate fiber is 0.5-5 mm.

6. The pressure ulcer care composition as described in claim 1, characterized in that, The excipients, by weight, include: 5-20 parts of humectant, 0.5-3 parts of penetration enhancer, 0.1-0.8 parts of antibacterial agent, and 30-60 parts of matrix.

7. The pressure ulcer care composition as described in claim 6, characterized in that, The moisturizer is a mixture of glycerin and sodium hyaluronate in a weight ratio of 15-20:1, the penetration enhancer is a compound of azone and menthol in a weight ratio of 1:0.3-0.8, the antibacterial agent is ethylparaben, and the matrix is ​​a mixture of carbomer and propylene glycol in a weight ratio of 1:8-10.

8. A method for preparing a pressure ulcer care pharmaceutical composition as described in any one of claims 1-7, characterized in that, Includes the following steps: (1) Phase separation preparation: (1a) Preparation of hydrogel phase: The matrix is ​​slowly added to 1-3 times the volume of purified water under high-speed shearing at 8000-10000 rpm, sheared for 5-10 minutes to disperse it evenly, and then allowed to stand at 2-8℃ for 12-24 hours to swell, so as to obtain a transparent hydrogel matrix. (1b) Preparation of active ingredient oil phase: The penetration enhancer, antibacterial agent, pentoxifylline, polyhexamethylene biguanide hydrochloride and magnolol are mixed and stirred at 40-45℃ to completely dissolve to obtain the oil phase; (1c) Preparation of water-soluble component solution: Astragalus extract, Angelica extract, Lithospermum extract, β-glucan, and total glycosides of Centella asiatica are dissolved in 1-3 times the volume of purified water to obtain water-soluble component solution; (2) Primary emulsification and homogenization: Under stirring at 200-400 rpm, the oil phase obtained in step (1b) is slowly added to the water-soluble component solution obtained in step (1c). After the addition is complete, the stirring speed is increased to 800-1000 rpm and stirring is continued for 15-20 minutes to obtain a primary emulsion. Then, the primary emulsion is subjected to high-pressure homogenization and cycling at 15-20 MPa for 2-3 times. (3) Low-temperature gelation: The primary emulsion obtained in step (2) is slowly added to the cold hydrogel base obtained in step (1a) and stirred until uniform; (4) Integration of components: (4a) Add the liquid-absorbing component to the mixture obtained in step (3) and stir at low speed for 5-10 minutes to disperse it evenly; (4b) Dissolve the recombinant human epidermal growth factor in 5-10 parts by weight of sterile water for injection at a temperature of 2-8°C, and then slowly add it to the system under very low stirring at 50-100 rpm. (5) Post-processing and shaping: Add a humectant to the system obtained in step (4), adjust the pH value of the system to 6.0-6.5 with a pH adjuster, filter it under sterile conditions through a 0.22μm microporous membrane, and fill it.

9. The method for preparing the pressure ulcer care pharmaceutical composition as described in claim 8, characterized in that, In step (1a), the temperature of the purified water is 4-10℃; In step (3), the temperature of the mixing system is controlled to be below 15°C; In step (4a), the speed of the low-speed stirring is 100-200 rpm, and the stirring paddle is an anchor type or a frame type.

10. The use of the pressure ulcer care composition according to any one of claims 1-5 in the preparation of a medical device or pharmaceutical product for the prevention and / or treatment of pressure ulcers.

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