A traditional Chinese medicine gel preparation for treating diabetic skin ulcers and a preparation method thereof

Abstract

The present application relates to the technical field of medical preparations, in particular to a traditional Chinese medicine gel preparation for treating diabetic skin ulcers and a preparation method thereof. The traditional Chinese medicine gel preparation comprises the following components in parts by weight: Coptis 5-10 parts, Sophora flavescens 2-5 parts, Radix et Rhizoma Rhei 5-10 parts, zinc oxide quantum dots 0.4-0.8 parts, outer gel matrix 30-50 parts, Astragalus membranaceus 10-20 parts, Angelica sinensis 8-15 parts, Panax notoginseng 5-10 parts, Salvia miltiorrhiza 8-15 parts, nano selenium 0.5-0.8 parts, Ginkgo biloba extract 3-8 parts, and inner gel matrix 30-50 parts. The present application adopts a unique double-layer gel structure, effectively combines antibacterial and healing effects, the outer gel can play an antibacterial role, the inner gel focuses on promoting wound healing, enhances the permeability and bioavailability of drugs, continuously releases drug efficacy, directly acts on the lesion site of diabetic skin ulcers, and the synergistic effect of the inner and outer components significantly improves the treatment effect.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparation technology, specifically to a traditional Chinese medicine gel preparation for treating diabetic skin ulcers and its preparation method. Background Technology

[0002] Diabetes is a chronic metabolic disease characterized by persistently high blood sugar levels due to insufficient insulin secretion or impaired insulin utilization. This persistent hyperglycemia not only causes widespread damage to the patient's organs and tissues throughout the body but also significantly affects the wound healing process, particularly in the healing of skin ulcers. Diabetic skin ulcers are one of the most common complications in diabetic patients, especially foot ulcers (diabetic foot). These ulcers typically heal slowly, are prone to infection, and can lead to serious complications such as gangrene, amputation, and even death, causing immense suffering and financial burden on patients.

[0003] In recent years, gel formulations have been widely used as a form of topical treatment for skin ulcers due to their good moisturizing properties, comfortable feel, and good adhesion to wounds. However, existing gel formulations for treating diabetic skin ulcers have several drawbacks that limit their efficacy and application. First, these gel formulations often have insufficient drug penetration, making it difficult to reach deep skin tissues, especially in diabetic patients whose skin barrier function is impaired, hindering the full effectiveness of the medication. Second, many gel formulations have limited moisturizing capabilities, easily leading to wound dryness and thus delaying wound healing. Furthermore, gels with insufficient antibacterial properties cannot effectively inhibit or kill pathogens, increasing the risk of infection. Some gel formulations also contain complex chemical components that may cause skin irritation or allergic reactions, especially for diabetic patients with sensitive skin. Short duration of efficacy is also a significant problem, requiring frequent replacements, increasing inconvenience and financial burden. Therefore, there is an urgent need for an improved gel formulation to enhance the treatment of diabetic skin ulcers and meet clinical needs. Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, this invention provides a traditional Chinese medicine gel preparation for treating diabetic skin ulcers and its preparation method. It adopts a unique double-layer gel structure, which effectively combines antibacterial and healing effects. The outer gel can exert antibacterial effects, while the inner gel focuses on promoting wound healing and tissue regeneration, enhancing drug permeability and bioavailability, and continuously releasing the drug effect, directly acting on the lesion site of diabetic skin ulcers. The synergistic effect of the inner and outer layer components significantly improves the therapeutic effect.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows: The present invention proposes a traditional Chinese medicine gel preparation for treating diabetic skin ulcers, the traditional Chinese medicine gel preparation comprising the following components in parts by weight: 5-10 parts of Coptis chinensis, 2-5 parts of Sophora flavescens, 5-10 parts of Rheum palmatum, 0.4-0.8 parts of zinc oxide quantum dots, 30-50 parts of outer gel matrix, 10-20 parts of Astragalus membranaceus, 8-15 parts of Angelica sinensis, 5-10 parts of Panax notoginseng, 8-15 parts of Salvia miltiorrhiza, 0.5-0.8 parts of nano selenium, 3-8 parts of Ginkgo biloba extract, and 30-50 parts of inner gel matrix.

[0006] Preferably, the method for preparing the zinc oxide quantum dots includes the following steps: A1. Prepare a 1-2 mmol / L zinc acetate ethanol solution and a 0.2 mol / L potassium hydroxide ethanol solution; A2. Add 50 mL of the zinc acetate ethanol solution prepared in step A1 dropwise to 10 mL of the potassium hydroxide ethanol solution prepared in step A1, and stir continuously at 400-600 rpm for 8-12 h. After the reaction is complete, centrifuge to obtain the product, wash it three times alternately with ethanol and deionized water, and then place it in a vacuum drying oven at 40-60℃ for 12-24 h to obtain zinc oxide quantum dots.

[0007] Preferably, the outer gel matrix is ​​composed of sodium alginate and sodium carboxymethyl cellulose in a mass ratio of 1:1.

[0008] Preferably, the inner gel matrix is ​​composed of chitosan and sodium hyaluronate in a mass ratio of 1:1.

[0009] Preferably, the preparation method of the ginkgo leaf extract includes the following steps: B1. Pulverize dried ginkgo leaves into powder with a diameter of 2 mm, add to ethanol, reflux at 60~80℃ for 12 h, filter to remove insoluble impurities, and obtain the extract. B2. Concentrate the extract prepared in step B1 under reduced pressure until it is reduced to 1 / 4 to 1 / 5 of its original volume to obtain concentrated ginkgo leaf extract. B3. The concentrated ginkgo leaf extract prepared in step B2 is purified by passing it through a resin adsorption column. The purified concentrated ginkgo leaf extract is then freeze-dried to obtain ginkgo leaf extract.

[0010] Preferably, in step B1, the ratio of ginkgo leaf powder to ethanol is 1~3 g: 100 mL.

[0011] This invention also proposes a method for preparing a traditional Chinese medicine gel preparation for treating diabetic skin ulcers, specifically including the following steps: S1. Weigh out the inner layer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform inner layer gel matrix solution. S2. Weigh out Astragalus membranaceus, Angelica sinensis, Panax notoginseng, Salvia miltiorrhiza, nano-selenium and Ginkgo biloba extract by weight and add them to the inner layer gel matrix solution prepared in step S1. Stir and disperse evenly to obtain the inner layer gel solution. S3. Place the inner layer gel solution prepared in step S2 into a homogenizer, set the homogenization pressure to 15000~20000psi, and homogenize 2~3 times to obtain inner layer gel microparticles. S4. Weigh out the outer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform outer gel matrix solution. S5. Weigh out Coptis chinensis, Sophora flavescens, rhubarb and zinc oxide quantum dots by weight and add them to the outer gel matrix solution prepared in step S4. Stir and disperse evenly to obtain the outer gel solution. S6. Add the inner layer gel microparticles prepared in step S3 to the outer layer gel solution prepared in step S5, stir at 300~500 rpm for 4~6 h at 30℃, pour into a mold after the reaction is completed, remove air bubbles by vacuum treatment, and freeze dry to obtain the traditional Chinese medicine gel preparation.

[0012] The beneficial effects of this invention are as follows: This invention combines the inner active ingredient with the outer matrix to form a traditional Chinese medicine gel preparation with a dual-layer structure, effectively combining antibacterial and healing effects to create a dual protection and treatment mechanism. This dual-layer architecture not only ensures the potent antibacterial function of the outer layer, providing immediate protection for the wound, but also promotes deep wound healing through the continuous release effect of the inner layer. The dual-layer design allows the drug to act synergistically at different levels, improving the overall therapeutic effect and prolonging the duration of efficacy, reducing the need for patients to frequently change medications.

[0013] The outer gel primarily serves an antibacterial protective function, ensuring the wound is protected from external pathogens. The outer gel matrix contains ingredients such as Coptis chinensis, Sophora flavescens, rhubarb, and zinc oxide quantum dots. Coptis chinensis is rich in berberine, which effectively inhibits the growth of various pathogens; Sophora flavescens contains matrine, which has broad-spectrum antibacterial and anti-inflammatory effects, further enhancing the antibacterial effect; rhubarb, with its unique anthraquinone compounds, not only inhibits bacteria but also helps remove necrotic tissue, keeping the wound clean and healthy; zinc oxide quantum dots, through their nanoscale particle structure, provide stronger antibacterial efficacy and have a mild anti-inflammatory effect. These ingredients work synergistically in the outer gel to ensure adequate protection of the wound in the early stages of treatment, preventing infection, while providing a continuous moisturizing environment to effectively prevent wound dryness, thereby promoting rapid wound healing.

[0014] The inner gel layer focuses on promoting wound healing and regeneration. Herbal ingredients such as Coptis chinensis, Sophora flavescens, and rhubarb are homogenized into nano- or micron-sized particles, significantly improving drug permeability and bioavailability. This allows the gel to directly target the lesions of diabetic skin ulcers, exerting potent antibacterial, anti-inflammatory, and healing-promoting effects. Astragalus membranaceus, a classic qi-tonifying herb, not only enhances immune function but also promotes skin cell proliferation and accelerates wound healing. Angelica sinensis helps replenish blood and promotes blood circulation, repairing damaged tissues and accelerating wound healing. Panax notoginseng, with its hemostatic, blood-stasis-dispersing, swelling-reducing, and pain-relieving effects, is particularly suitable for the recovery period of wound healing. Salvia miltiorrhiza improves microcirculation through its blood-activating, stasis-removing, and antioxidant effects, further accelerating tissue repair. Nano-selenium, as a powerful antioxidant, reduces oxidative stress damage to the wound, protects tissue cells, and promotes regeneration. Ginkgo biloba extract effectively reduces wound inflammation by inhibiting the release of inflammatory mediators. Through its rational structural design, this formulation allows the inner and outer layers to fully exert their respective effects on the wound surface, working synergistically to enhance the overall therapeutic effect. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only for this invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a transmission electron microscope image of the zinc oxide quantum dots prepared in Example 1 of the present invention; Figure 2 These are test graphs showing the antibacterial properties of the traditional Chinese medicine gel preparations prepared in Examples 1-3 and Comparative Examples 1-2. Detailed Implementation

[0017] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. It should be noted that, unless otherwise specified, the raw materials involved in the present invention are all purchased through conventional commercial channels.

[0018] Example 1: This example proposes a traditional Chinese medicine gel preparation for treating diabetic skin ulcers. The traditional Chinese medicine gel preparation comprises the following components in parts by weight: 10 parts Coptis chinensis, 2 parts Sophora flavescens, 7 parts Rheum palmatum, 0.6 parts zinc oxide quantum dots, 40 parts outer gel matrix, 20 parts Astragalus membranaceus, 8 parts Angelica sinensis, 10 parts Panax notoginseng, 10 parts Salvia miltiorrhiza, 0.8 parts nano selenium, 6 parts Ginkgo biloba extract, and 40 parts inner gel matrix.

[0019] The method for preparing the zinc oxide quantum dots includes the following steps: A1. Prepare a 2 mmol / L zinc acetate ethanol solution and a 0.2 mol / L potassium hydroxide ethanol solution; A2. Add 50 mL of the zinc acetate ethanol solution prepared in step A1 dropwise to 10 mL of the potassium hydroxide ethanol solution prepared in step A1, and stir continuously at 600 rpm for 8 h. After the reaction is completed, centrifuge to obtain the product, wash it three times alternately with ethanol and deionized water, and then place it in a vacuum drying oven at 60℃ for 12 h to obtain zinc oxide quantum dots.

[0020] The outer gel matrix is ​​composed of sodium alginate and sodium carboxymethyl cellulose in a mass ratio of 1:1.

[0021] The inner gel matrix is ​​composed of chitosan and sodium hyaluronate in a mass ratio of 1:1.

[0022] The preparation method of the Ginkgo biloba extract includes the following steps: B1. Pulverize 3 g of dried ginkgo leaves into ginkgo leaf powder with a diameter of 2 mm, add it to 100 mL of ethanol, reflux at 80℃ for 12 h, filter to remove insoluble impurities, and obtain the extract. B2. Concentrate the extract prepared in step B1 under reduced pressure until it is reduced to 1 / 4 of its original volume to obtain concentrated ginkgo leaf extract. B3. The concentrated ginkgo leaf extract prepared in step B2 is purified by passing it through a resin adsorption column. The purified concentrated ginkgo leaf extract is then freeze-dried to obtain ginkgo leaf extract.

[0023] This embodiment also proposes a method for preparing a traditional Chinese medicine gel preparation for treating diabetic skin ulcers, specifically including the following steps: S1. Weigh out the inner layer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform inner layer gel matrix solution. S2. Weigh out Astragalus membranaceus, Angelica sinensis, Panax notoginseng, Salvia miltiorrhiza, nano-selenium and Ginkgo biloba extract by weight and add them to the inner layer gel matrix solution prepared in step S1. Stir and disperse evenly to obtain the inner layer gel solution. S3. Place the inner layer gel solution prepared in step S2 into a homogenizer, set the homogenization pressure to 20000 psi, and homogenize twice to obtain inner layer gel microparticles. S4. Weigh out the outer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform outer gel matrix solution. S5. Weigh out Coptis chinensis, Sophora flavescens, rhubarb and zinc oxide quantum dots by weight and add them to the outer gel matrix solution prepared in step S4. Stir and disperse evenly to obtain the outer gel solution. S6. Add the inner layer gel microparticles prepared in step S3 to the outer layer gel solution prepared in step S5, stir at 30°C and 500 rpm for 4 h, pour into a mold after the reaction is completed, remove air bubbles by vacuum treatment, and freeze dry to obtain the traditional Chinese medicine gel preparation.

[0024] Example 2: This example proposes a traditional Chinese medicine gel preparation for treating diabetic skin ulcers. The traditional Chinese medicine gel preparation comprises the following components in parts by weight: 5 parts Coptis chinensis, 5 parts Sophora flavescens, 10 parts Rheum palmatum, 0.4 parts zinc oxide quantum dots, 30 parts outer gel matrix, 10 parts Astragalus membranaceus, 15 parts Angelica sinensis, 5 parts Panax notoginseng, 8 parts Salvia miltiorrhiza, 0.5 parts nano selenium, 8 parts Ginkgo biloba extract, and 50 parts inner gel matrix.

[0025] The method for preparing the zinc oxide quantum dots includes the following steps: A1. Prepare a 1 mmol / L zinc acetate ethanol solution and a 0.2 mol / L potassium hydroxide ethanol solution; A2. Add 50 mL of the zinc acetate ethanol solution prepared in step A1 dropwise to 10 mL of the potassium hydroxide ethanol solution prepared in step A1, and stir continuously at 400 rpm for 12 h. After the reaction is completed, centrifuge to obtain the product, wash it three times alternately with ethanol and deionized water, and then place it in a vacuum drying oven at 40℃ for 24 h to obtain zinc oxide quantum dots.

[0026] The outer gel matrix is ​​composed of sodium alginate and sodium carboxymethyl cellulose in a mass ratio of 1:1.

[0027] The inner gel matrix is ​​composed of chitosan and sodium hyaluronate in a mass ratio of 1:1.

[0028] The preparation method of the Ginkgo biloba extract includes the following steps: B1. Pulverize 2 g of dried ginkgo leaves into ginkgo leaf powder with a diameter of 2 mm, add it to 100 mL of ethanol, reflux at 60℃ for 12 h, filter to remove insoluble impurities, and obtain the extract. B2. Concentrate the extract prepared in step B1 under reduced pressure until it is reduced to 1 / 5 of its original volume to obtain concentrated ginkgo leaf extract. B3. The concentrated ginkgo leaf extract prepared in step B2 is purified by passing it through a resin adsorption column. The purified concentrated ginkgo leaf extract is then freeze-dried to obtain ginkgo leaf extract.

[0029] This embodiment also proposes a method for preparing a traditional Chinese medicine gel preparation for treating diabetic skin ulcers, specifically including the following steps: S1. Weigh out the inner layer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform inner layer gel matrix solution. S2. Weigh out Astragalus membranaceus, Angelica sinensis, Panax notoginseng, Salvia miltiorrhiza, nano-selenium and Ginkgo biloba extract by weight and add them to the inner layer gel matrix solution prepared in step S1. Stir and disperse evenly to obtain the inner layer gel solution. S3. Place the inner layer gel solution prepared in step S2 into a homogenizer, set the homogenization pressure to 15000 psi, and homogenize it 3 times to obtain inner layer gel microparticles. S4. Weigh out the outer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform outer gel matrix solution. S5. Weigh out Coptis chinensis, Sophora flavescens, rhubarb and zinc oxide quantum dots by weight and add them to the outer gel matrix solution prepared in step S4. Stir and disperse evenly to obtain the outer gel solution. S6. Add the inner layer gel microparticles prepared in step S3 to the outer layer gel solution prepared in step S5, stir at 300 rpm for 6 h at 30°C, pour into a mold after the reaction is completed, remove air bubbles by vacuum treatment, and freeze dry to obtain the traditional Chinese medicine gel preparation.

[0030] Example 3: This example proposes a traditional Chinese medicine gel preparation for treating diabetic skin ulcers. The traditional Chinese medicine gel preparation comprises the following components in parts by weight: 7 parts Coptis chinensis, 3 parts Sophora flavescens, 5 parts Rheum palmatum, 0.8 parts zinc oxide quantum dots, 50 parts outer gel matrix, 16 parts Astragalus membranaceus, 11 parts Angelica sinensis, 7 parts Panax notoginseng, 15 parts Salvia miltiorrhiza, 0.6 parts nano selenium, 3 parts Ginkgo biloba extract, and 30 parts inner gel matrix.

[0031] The method for preparing the zinc oxide quantum dots includes the following steps: A1. Prepare a 1.5 mmol / L zinc acetate ethanol solution and a 0.2 mol / L potassium hydroxide ethanol solution; A2. Add 50 mL of the zinc acetate ethanol solution prepared in step A1 dropwise to 10 mL of the potassium hydroxide ethanol solution prepared in step A1, and stir continuously at 500 rpm for 10 h. After the reaction is completed, centrifuge to obtain the product, wash it three times alternately with ethanol and deionized water, and then place it in a vacuum drying oven at 50 °C for 16 h to obtain zinc oxide quantum dots.

[0032] The outer gel matrix is ​​composed of sodium alginate and sodium carboxymethyl cellulose in a mass ratio of 1:1.

[0033] The inner gel matrix is ​​composed of chitosan and sodium hyaluronate in a mass ratio of 1:1.

[0034] The preparation method of the Ginkgo biloba extract includes the following steps: B1. Pulverize 1 g of dried ginkgo leaves into ginkgo leaf powder with a diameter of 2 mm, add it to 100 mL of ethanol, reflux at 70℃ for 12 h, filter to remove insoluble impurities, and obtain the extract. B2. Concentrate the extract prepared in step B1 under reduced pressure until it is reduced to 1 / 5 of its original volume to obtain concentrated ginkgo leaf extract. B3. The concentrated ginkgo leaf extract prepared in step B2 is purified by passing it through a resin adsorption column. The purified concentrated ginkgo leaf extract is then freeze-dried to obtain ginkgo leaf extract.

[0035] This embodiment also proposes a method for preparing a traditional Chinese medicine gel preparation for treating diabetic skin ulcers, specifically including the following steps: S1. Weigh out the inner layer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform inner layer gel matrix solution. S2. Weigh out Astragalus membranaceus, Angelica sinensis, Panax notoginseng, Salvia miltiorrhiza, nano-selenium and Ginkgo biloba extract by weight and add them to the inner layer gel matrix solution prepared in step S1. Stir and disperse evenly to obtain the inner layer gel solution. S3. Place the inner layer gel solution prepared in step S2 into a homogenizer, set the homogenization pressure to 18000 psi, and homogenize it 3 times to obtain inner layer gel microparticles. S4. Weigh out the outer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform outer gel matrix solution. S5. Weigh out Coptis chinensis, Sophora flavescens, rhubarb and zinc oxide quantum dots by weight and add them to the outer gel matrix solution prepared in step S4. Stir and disperse evenly to obtain the outer gel solution. S6. Add the inner layer gel microparticles prepared in step S3 to the outer layer gel solution prepared in step S5, stir at 30°C and 400 rpm for 5 h, pour into a mold after the reaction is completed, remove air bubbles by vacuum treatment, and freeze dry to obtain the traditional Chinese medicine gel preparation.

[0036] Comparative Example 1: This comparative example presents a traditional Chinese medicine gel preparation for treating diabetic skin ulcers. The only difference between this example and Example 1 is that zinc oxide quantum dots are not added. All other components, component contents, and experimental steps are the same as in Example 1.

[0037] Comparative Example 2: This comparative example presents a traditional Chinese medicine gel preparation for treating diabetic skin ulcers. The only difference between this preparation and Example 1 is that it does not use a double-layer structure. All other components and their contents are the same as in Example 1. The traditional Chinese medicine gel preparation includes the following components in parts by weight: 10 parts Coptis chinensis, 2 parts Sophora flavescens, 7 parts Rheum palmatum, 0.6 parts zinc oxide quantum dots, 40 parts outer gel matrix, 20 parts Astragalus membranaceus, 8 parts Angelica sinensis, 10 parts Panax notoginseng, 10 parts Salvia miltiorrhiza, 0.8 parts nano selenium, 6 parts Ginkgo biloba extract, and 40 parts inner gel matrix.

[0038] The method for preparing the zinc oxide quantum dots includes the following steps: A1. Prepare a 2 mmol / L zinc acetate ethanol solution and a 0.2 mol / L potassium hydroxide ethanol solution; A2. Add 50 mL of the zinc acetate ethanol solution prepared in step A1 dropwise to 10 mL of the potassium hydroxide ethanol solution prepared in step A1, and stir continuously at 600 rpm for 8 h. After the reaction is completed, centrifuge to obtain the product, wash it three times alternately with ethanol and deionized water, and then place it in a vacuum drying oven at 60℃ for 12 h to obtain zinc oxide quantum dots.

[0039] The outer gel matrix is ​​composed of sodium alginate and sodium carboxymethyl cellulose in a mass ratio of 1:1.

[0040] The inner gel matrix is ​​composed of chitosan and sodium hyaluronate in a mass ratio of 1:1.

[0041] The preparation method of the Ginkgo biloba extract includes the following steps: B1. Pulverize 3 g of dried ginkgo leaves into ginkgo leaf powder with a diameter of 2 mm, add it to 100 mL of ethanol, reflux at 80℃ for 12 h, filter to remove insoluble impurities, and obtain the extract. B2. Concentrate the extract prepared in step B1 under reduced pressure until it is reduced to 1 / 4 of its original volume to obtain concentrated ginkgo leaf extract. B3. The concentrated ginkgo leaf extract prepared in step B2 is purified by passing it through a resin adsorption column. The purified concentrated ginkgo leaf extract is then freeze-dried to obtain ginkgo leaf extract.

[0042] This comparative example also proposes a method for preparing a traditional Chinese medicine gel preparation for treating diabetic skin ulcers, specifically including the following steps: S1. Weigh out the inner layer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform inner layer gel matrix solution. S2. Weigh out Astragalus membranaceus, Angelica sinensis, Panax notoginseng, Salvia miltiorrhiza, nano-selenium and Ginkgo biloba extract by weight and add them to the inner layer gel matrix solution prepared in step S1. Stir and disperse evenly to obtain the inner layer gel solution. S3. Weigh out the outer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform outer gel matrix solution. S4. Weigh out Coptis chinensis, Sophora flavescens, rhubarb and zinc oxide quantum dots by weight and add them to the outer gel matrix solution prepared in step S4. Stir and disperse evenly to obtain the outer gel solution. S5. Add the inner gel solution prepared in step S2 to the outer gel solution prepared in step S5, stir at 30°C and 500 rpm for 4 h, pour into a mold after the reaction is completed, remove air bubbles by vacuum treatment, and freeze dry to obtain the traditional Chinese medicine gel preparation.

[0043] Experimental Example 1: The microstructure of the zinc oxide quantum dots prepared in Example 1 was observed using a transmission electron microscope.

[0044] Figure 1 The image shows a transmission electron microscope (TEM) image of the zinc oxide quantum dots prepared in Example 1 of this invention. As shown in the figure, the zinc oxide quantum dots have a small particle size, with a diameter of about 10 nm, and slight agglomeration. The 0.24 nm lattice spacing shown in the inset image belongs to the diffraction of the (101) crystal plane of the zinc oxide quantum dots, indicating the successful preparation of zinc oxide quantum dots.

[0045] Experiment Example 2: Antibacterial Performance Test: Prepare and sterilize LB medium. When the medium cools to approximately 45°C, pour 20 mL into sterile Petri dishes and allow it to solidify. Take a Staphylococcus aureus culture in the logarithmic growth phase and dilute it with sterile physiological saline to a concentration of 1×10^6 CFU / mL. Take 200 µL of the diluted Staphylococcus aureus culture and spread it evenly on the surface of the Petri dish, allowing it to stand for 5 minutes to allow bacterial adsorption. Using sterile filter paper (6 mm in diameter), take an appropriate amount of the traditional Chinese medicine gel preparation and a blank gel, place the filter paper on an agar plate coated with the bacterial solution, and gently press it down. Place the agar plate in a 37°C incubator and incubate for 24 hours. Observe and measure the diameter (mm) of the inhibition zone around the filter paper.

[0046] Figure 2 The figures show the antibacterial performance test results of the traditional Chinese medicine gel preparations prepared in Examples 1-3 and Comparative Examples 1-2. As shown in the figures, the antibacterial zones of the traditional Chinese medicine gel preparations prepared in Examples 1-3 are larger, much larger than those in Comparative Examples 1-2. Among them, the antibacterial zone of Comparative Example 1 is the smallest, indicating that zinc oxide quantum dots can significantly improve the antibacterial performance of the traditional Chinese medicine mixture. At the same time, the construction of the double-layer structure is also beneficial to the inhibitory effect of the traditional Chinese medicine gel preparation on bacteria.

[0047] Experiment Example 3: Wound Healing Performance Test: Eight-week-old C57BL / 6 mice were used to induce a diabetic model by intraperitoneal injection of streptozotocin (STZ). Each mouse was injected with 50 mg / kg of STZ for 5 consecutive days. Fasting blood glucose was measured after 14 days, and mice with blood glucose levels higher than 16.7 mmol / L were considered diabetic model mice. A standardized circular wound model was established by removing a full-thickness skin with a diameter of about 8 mm from the back of the diabetic model mice using a skin punch. The corresponding traditional Chinese medicine gel preparations (Examples 1-3 and Comparative Examples 1-2) were evenly applied to the wound daily for 12 days. On days 2, 6, and 12 of treatment, the changes in wound area were recorded, and the wound healing rate was calculated (healing rate = [initial wound area - residual wound area] / initial wound area × 100%). The test results are shown in Table 1.

[0048] Table 1 Wound healing performance test

[0049] The wound healing performance tests are shown in the table above. The traditional Chinese medicine gel preparations of Examples 1-3 have significant effects in treating diabetic skin ulcers. In particular, the combination of a double-layer structure and zinc oxide quantum dots not only improves drug permeability and bioavailability but also enhances antibacterial ability and promotes rapid wound healing. In contrast, the healing effects of Comparative Examples 1 and 2 are significantly worse than those of the Examples, verifying that the double-layer structure and zinc oxide quantum dots help improve the treatment effect of diabetic skin ulcers.

[0050] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention. The actual application is not limited to this. In conclusion, if those skilled in the art are inspired by this description and design similar methods and embodiments without departing from the spirit of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine gel preparation for treating diabetic skin ulcers, characterized in that, The traditional Chinese medicine gel preparation is composed of the following components in parts by weight: 5-10 parts Coptis chinensis, 2-5 parts Sophora flavescens, 5-10 parts Rheum palmatum, 0.4-0.8 parts zinc oxide quantum dots, 30-50 parts outer gel matrix, 10-20 parts Astragalus membranaceus, 8-15 parts Angelica sinensis, 5-10 parts Panax notoginseng, 8-15 parts Salvia miltiorrhiza, 0.5-0.8 parts nano selenium, 3-8 parts Ginkgo biloba extract, and 30-50 parts inner gel matrix. The method for preparing the zinc oxide quantum dots includes the following steps: A1. Prepare zinc acetate ethanol solution and potassium hydroxide ethanol solution; A2. Add the zinc acetate ethanol solution prepared in step A1 dropwise to the potassium hydroxide ethanol solution prepared in step A1, and stir continuously for 8-12 h. After the reaction is completed, centrifuge to obtain the product, wash it three times alternately with ethanol and deionized water, and dry it under vacuum to obtain zinc oxide quantum dots.

2. The traditional Chinese medicine gel preparation for treating diabetic skin ulcers according to claim 1, characterized in that, The outer gel matrix is ​​composed of sodium alginate and sodium carboxymethyl cellulose in a mass ratio of 1:

1.

3. The traditional Chinese medicine gel preparation for treating diabetic skin ulcers according to claim 2, characterized in that, The inner gel matrix is ​​composed of chitosan and sodium hyaluronate in a mass ratio of 1:

1.

4. The traditional Chinese medicine gel preparation for treating diabetic skin ulcers according to claim 3, characterized in that, The preparation method of the Ginkgo biloba extract includes the following steps: B1. Pulverize the dried ginkgo leaves into ginkgo leaf powder, add it to ethanol, reflux at 60~80℃ for 12 h, filter to remove insoluble impurities, and obtain the extract. B2. Concentrate the extract prepared in step B1 under reduced pressure until it is reduced to 1 / 4 to 1 / 5 of its original volume to obtain concentrated ginkgo leaf extract. B3. The concentrated ginkgo leaf extract prepared in step B2 is purified by passing it through a resin adsorption column. The purified concentrated ginkgo leaf extract is then freeze-dried to obtain ginkgo leaf extract.

5. A traditional Chinese medicine gel preparation for treating diabetic skin ulcers according to claim 4, characterized in that, In step B1, the ratio of ginkgo leaf powder to ethanol is 1~3 g: 100 mL.

6. A method for preparing a traditional Chinese medicine gel preparation for treating diabetic skin ulcers as described in any one of claims 1-5, characterized in that, Specifically, the following steps are included: S1. Weigh out the inner layer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform inner layer gel matrix solution. S2. Weigh out Astragalus membranaceus, Angelica sinensis, Panax notoginseng, Salvia miltiorrhiza, nano-selenium and Ginkgo biloba extract by weight and add them to the inner layer gel matrix solution prepared in step S1. Stir and disperse evenly to obtain the inner layer gel solution. S3. Place the inner layer gel solution prepared in step S2 into a homogenizer, set the homogenization pressure to 15000~20000 psi, and homogenize 2~3 times to obtain inner layer gel microparticles. S4. Weigh out the outer gel matrix by weight, add 4 times the weight of water, stir to dissolve and form a uniform outer gel matrix solution. S5. Weigh out Coptis chinensis, Sophora flavescens, rhubarb and zinc oxide quantum dots by weight and add them to the outer gel matrix solution prepared in step S4. Stir and disperse evenly to obtain the outer gel solution. S6. Add the inner layer gel microparticles prepared in step S3 to the outer layer gel solution prepared in step S5, stir at 30°C for 4-6 hours, pour into a mold after the reaction is completed, remove air bubbles by vacuum treatment, and freeze dry to obtain the traditional Chinese medicine gel preparation.

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