Traditional Chinese medicine coated granulation-promoting repair agent for treating diabetic foot ulcer

Abstract

The invention discloses a traditional Chinese medicine coated granulation-promoting repair agent for treating diabetic foot ulcer, and belongs to the technical field of traditional Chinese medicine external preparations. Aiming at the defects that existing related preparations are poor in fitting property, uneven in drug release and incapable of meeting stepped treatment requirements, the invention selects seven traditional Chinese medicines of dragon's blood, angelica sinensis, honeysuckle, fructus forsythiae, safflower carthamus, astragalus membranaceus and rhizoma bletillae for compatibility, constructs a synergistic system for clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, tonifying qi and promoting tissue regeneration, and adopts gradient extraction of alcohol extraction and water extraction. The preparation method comprises the following steps: taking process enriched effective components; carrying out ultrasonic dispersion; taking polyvinyl alcohol bletilla gum as a composite film-forming material; and matching with glycerol and polysorbate-80 to prepare the film agent. The repairing agent can be stably attached to a wound surface, realizes uniform and continuous release of a drug, can accurately match a stepped repairing process for removing necrotic tissue, activating blood and promoting granulation, has a wound healing rate of 85% or more after 20 days of treatment, has significant anti-inflammatory and angiogenesis promoting effects, has good dosage form stability and no obvious irritation, is convenient to use, and can promote patients. Due to compliance, wound infection and amputation risks can be reduced, and the external application medicine is suitable for external treatment of diabetic foot ulcer.

Description

Technical Field

[0001] This invention relates to the field of external application of traditional Chinese medicine, and in particular to a traditional Chinese medicine coating and tissue-regenerating repair agent for treating diabetic foot ulcers. Background Technology

[0002] Diabetic foot ulcers are one of the most serious chronic complications of diabetes. Their pathological mechanisms are complex and are mainly related to factors such as peripheral neuropathy, vascular disease and infection. The wounds are difficult to heal, and improper treatment can easily lead to the spread of infection and even amputation, which seriously affects the patient's quality of life and increases the medical burden.

[0003] Currently, the main topical Chinese medicine preparations for diabetic foot ulcers include ointments, powders, and films made from single film-forming materials. However, existing formulations of this type have many insurmountable defects in practical applications: First, poor wound adhesion. Diabetic foot ulcers are often irregular, and existing formulations are prone to falling off, failing to achieve continuous wound coverage and resulting in unstable drug action on the wound. Second, uneven drug release. Due to unreasonable formulation design and poor drug dispersion, the drug concentration at the wound site is prone to being too high or too low. Too high a concentration may cause local irritation, while too low a concentration will not achieve an effective therapeutic concentration. Third, insufficient formulation stability. Ointments are prone to layering and mold growth, powders are prone to absorbing moisture and clumping, and films made of single film-forming materials have poor flexibility and are prone to breakage, affecting storage and usage effectiveness. Fourth, weak targeted tissue regeneration and repair. The healing of diabetic foot ulcers requires a step-by-step process of "debridement-blood circulation-tissue regeneration." Existing formulations mostly focus on only a single repair stage and cannot synergistically meet the repair needs of each stage, resulting in limited treatment effects. Patient compliance is generally low due to long treatment cycles, poor efficacy, and inconvenience of use.

[0004] Therefore, developing a topical Chinese medicine preparation that can achieve stable wound adhesion, uniform and continuous drug release, good dosage form stability, and accurately match the stepwise treatment needs of "debridement-blood circulation-tissue regeneration" is of great significance for improving the treatment effect of diabetic foot ulcers, increasing patient compliance, and reducing the risk of amputation. It is also a technical problem that urgently needs to be solved in the field of topical Chinese medicine preparations. Summary of the Invention

[0005] In view of this, the present invention aims to provide a traditional Chinese medicine coating and tissue-regenerating repair agent for treating diabetic foot ulcers, so as to solve or alleviate the technical problems existing in the prior art, and at least provide a beneficial option.

[0006] The objective of this invention can be achieved through the following technical measures: a traditional Chinese medicine coating for treating diabetic foot ulcers, prepared from traditional Chinese medicine raw materials and excipients, wherein the traditional Chinese medicine raw materials are, by weight: 5-10 parts of dragon's blood, 10-15 parts of angelica sinensis, 15-20 parts of honeysuckle, 12-18 parts of forsythia suspensa, 8-12 parts of safflower, 15-25 parts of astragalus membranaceus, and 10-15 parts of bletilla striata; wherein the excipients are, by weight: 10-15 parts of polyvinyl alcohol, 5-8 parts of bletilla striata gum, 3-5 parts of glycerin, 2 parts of polysorbate-801, and 80-100 parts of distilled water.

[0007] The objective of this invention can also be achieved through the following technical measures: A method for preparing a traditional Chinese medicine coating for treating diabetic foot ulcers and promoting tissue regeneration and repair includes the following steps: (1) Gradient extraction: Angelica sinensis, safflower and dragon's blood were extracted by alcohol extraction, while honeysuckle, forsythia, astragalus and bletilla were extracted by water extraction. The alcohol extract and water extract were combined and then ultrasonically dispersed to obtain the extract of effective components of traditional Chinese medicine. (2) Composite film formation: Polyvinyl alcohol and Bletilla striata gum are dissolved in distilled water, glycerin and polysorbate-80 are added in sequence and stirred evenly, and then the extract of the effective components of the Chinese medicine is added and mixed. After coating, drying, peeling and cutting, a film is obtained.

[0008] The objective of this invention can also be achieved through the following technical measures: The weight ratio of the Chinese medicinal materials is as follows: 7 parts of dragon's blood, 12 parts of angelica sinensis, 18 parts of honeysuckle, 15 parts of forsythia suspensa, 10 parts of safflower, 20 parts of astragalus membranaceus, and 12 parts of bletilla striata.

[0009] The objective of this invention can also be achieved through the following technical measures: After pulverizing Angelica sinensis, safflower, and dragon's blood, pass them through an 80-mesh sieve. Add 8-10 times their weight of 70%-80% ethanol solution and reflux extract twice at 60-70℃, each time for 2-3 hours. Combine the ethanol extracts, filter, and concentrate under reduced pressure to a concentrated ethanol extract with a relative density of 1.10-1.15 at 60℃.

[0010] The objective of this invention can also be achieved through the following technical measures: The conditions for the water extraction process described in step (1) are as follows: honeysuckle, forsythia, astragalus, and bletilla are pulverized and passed through a 60-mesh sieve. 10-12 times the weight of distilled water is added, and the mixture is decocted and extracted twice at 90-100℃ for 1.5-2 hours each time. The water extracts are combined, filtered, and concentrated under reduced pressure to a water extract concentrate with a relative density of 1.05-1.10 at 60℃.

[0011] The objective of this invention can also be achieved through the following technical measures: The conditions for ultrasonic dispersion in step (1) are: power 200-300W, temperature 30-40℃, ultrasonic dispersion for 30-40min, stirring once every 10min during the process, and filtering after ultrasonic dispersion to obtain the extract of the effective components of the Chinese medicine.

[0012] The objective of this invention can also be achieved through the following technical measures: The dissolution conditions for polyvinyl alcohol and Bletilla striata gum in step (2) are: stirring and dissolving in a water bath at 70-80℃ to form a uniform film-forming material solution; the coating thickness is 0.2-0.3mm, and the drying conditions are vacuum drying at 40-50℃ for 2-3h.

[0013] The objective of this invention can also be achieved through the following technical measures: The weight ratio of the excipients is as follows: 12 parts polyvinyl alcohol, 6 parts Bletilla striata gum, 4 parts glycerin, 1.5 parts polysorbate-80, and 90 parts distilled water.

[0014] The objective of this invention can also be achieved through the following technical measures: The volume ratio of the extract of effective components of traditional Chinese medicine to the film-forming material solution in step (2) is 1:3-1:5.

[0015] The objective of this invention can also be achieved through the following technical measures: The repair agent is suitable for diabetic foot ulcer wounds that require a step-by-step repair process of "debridement-blood circulation-tissue regeneration".

[0016] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: I. Significantly Improved Wound Adhesion and Drug Release Stability: This invention uses a polyvinyl alcohol-bletilla striata composite film-forming material, combined with glycerin plasticizing and polysorbate-80 emulsification optimization. The prepared film can adhere tightly to irregular wounds of diabetic foot ulcers, achieving stable adhesion without falling off for 8-12 hours. This ensures continuous and uniform drug release at the wound site, avoiding the defects of poor adhesion and easy drug loss in existing formulations, and providing a stable drug action environment for stepwise repair.

[0017] II. Achieving a step-by-step synergistic treatment of "debridement-blood circulation-tissue regeneration" with excellent wound healing effect: The synergistic system of "heat-clearing and detoxification-blood circulation-qi-tissue regeneration" constructed by the combination of seven Chinese herbs can accurately match the repair process of diabetic foot ulcers. In the early stage, the heat-clearing and detoxifying effects of honeysuckle and forsythia remove necrotic tissue and inhibit infection. In the middle stage, the blood circulation-activating and stasis-removing effects of angelica, safflower, and dragon's blood improve local blood circulation and promote the dissipation of blood stasis. In the later stage, the qi-tissue regeneration effects of astragalus and bletilla accelerate the growth of granulation tissue. Combined with the gradient extraction process to fully enrich the effective components of each stage, the experimental verification shows that the wound healing rate of the repair agent of this invention can reach more than 85% after 20 days of treatment, which is significantly better than the existing topical Chinese medicine preparations.

[0018] III. Significant anti-inflammatory and angiogenesis-promoting effects: The effective components of traditional Chinese medicine in the repair agent of this invention can significantly reduce the level of local inflammatory factors (such as TNF-α and IL-6) in the wound, alleviate the inflammatory response of the wound, and at the same time promote the expression of vascular endothelial growth factor (VEGF), accelerate angiogenesis, provide sufficient nutritional supply for wound healing, and further enhance the repair effect.

[0019] IV. Good dosage form stability, high safety, and improved patient compliance: The film prepared by this invention shows no significant stability issues such as discoloration, cracking, or mold growth when stored at room temperature and sealed for 6 months; skin irritation tests have verified that it has no significant irritation to normal skin and the skin around ulcers; the film is convenient to use, can be cut according to the size of the wound, adheres stably and without significant discomfort, effectively solving the problem of low patient compliance caused by the inconvenience and poor efficacy of existing formulations.

[0020] V. Broad application prospects and high clinical value: This invention can be directly applied to the external treatment of diabetic foot ulcers, especially suitable for wounds that require a stepwise repair process of "cleansing necrotic tissue, promoting blood circulation, and promoting tissue regeneration". It can significantly reduce the risk of wound infection and amputation, providing a new and effective solution for the clinical treatment of diabetic foot ulcers. It has important promotion and application value in the field of traditional Chinese medicine external preparations.

[0021] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application 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 some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the logical structure of traditional Chinese medicine compatibility in this invention; Figure 2 This is a flow chart of the repair agent preparation process of the present invention; Figure 3 This is a schematic diagram of the step-by-step treatment mechanism of the present invention. Detailed Implementation

[0024] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0025] It is important to note that terms such as "first," "second," "symmetric," and "array" are used only to distinguish between descriptive and positional descriptions and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features specified with terms such as "first" or "symmetric" may explicitly or implicitly include one or more of that feature; similarly, when the quantity of certain features is not limited by words such as "two" or "three," it should be noted that such features also explicitly or implicitly include one or more features. In this invention, unless otherwise explicitly specified and limited, terms such as "installation," "connection," and "fixation" should be interpreted broadly; for example, they can refer to a fixed connection, a detachable connection, or an integral molding; they can refer to a mechanical connection, a direct connection, a welding connection, or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the accompanying drawings and specific circumstances.

[0026] The embodiments of the present invention will be described in detail below.

[0027] like Figure 1-3 As shown, a traditional Chinese medicine film-coated tissue-regenerating and repairing agent for treating diabetic foot ulcers is based on the construction of a synergistic treatment system of "clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and invigorating qi and promoting tissue regeneration," and combines gradient extraction technology with composite film-forming technology to prepare the film-forming agent. The specific steps include: Chinese herbal raw material compatibility Seven Chinese medicinal herbs were selected as raw materials: dragon's blood, angelica, honeysuckle, forsythia, safflower, astragalus, and bletilla. The weight ratio of each raw material was as follows: dragon's blood 5-10 parts, angelica 10-15 parts, honeysuckle 15-20 parts, forsythia 12-18 parts, safflower 8-12 parts, astragalus 15-25 parts, and bletilla 10-15 parts.

[0028] The design of this formula is based on the fact that diabetic foot ulcers are often accompanied by symptoms of heat toxicity and blood stasis, as well as deficiency of qi and blood. Therefore, it is necessary to address the issues of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and tonifying qi and promoting tissue regeneration. Honeysuckle and forsythia are the principal herbs for clearing heat and detoxifying, effectively removing heat toxicity from the wound and inhibiting infection, thus solving the core problem of the "cleaning necrotic tissue" stage. Angelica sinensis, safflower, and dragon's blood are the assistant herbs for promoting blood circulation and removing blood stasis. Angelica sinensis tonifies and invigorates blood, safflower invigorates blood and unblocks menstruation, and dragon's blood invigorates blood, removes blood stasis, and relieves pain. Together, these three herbs improve local blood circulation in the wound, promote the dissipation of blood stasis, and provide support for the "blood invigoration" stage. Astragalus membranaceus and Bletilla striata are the adjuvant herbs for tonifying qi and promoting tissue regeneration. Astragalus membranaceus invigorates qi and strengthens the spleen, promotes detoxification and tissue regeneration, while Bletilla striata astringes, stops bleeding, reduces swelling, and promotes tissue regeneration. Together, they promote the growth of granulation tissue in the wound, accelerate wound healing, and fulfill the repair needs of the "tissue regeneration" stage. The combination of these seven Chinese herbs forms a synergistic system, precisely matching the step-by-step treatment logic of "cleaning necrotic tissue - promoting blood circulation - tissue regeneration."

[0029] Gradient extraction and ultrasonic dispersion of active ingredients in traditional Chinese medicine Because the active ingredients in the above seven Chinese herbs have different polarities, a single extraction method cannot fully enrich the active ingredients. Therefore, a gradient extraction process of "alcohol extraction + water extraction" is adopted. The specific steps are as follows: (1) Alcohol extraction: Take Angelica sinensis, safflower and dragon's blood, crush them, pass them through an 80-mesh sieve, add 8-10 times the weight of 70%-80% ethanol solution, reflux extract twice at 60-70℃, each time for 2-3 hours, combine the two alcohol extracts, filter, and concentrate under reduced pressure to an alcohol extract concentrate with a relative density of 1.10-1.15 (60℃) for later use; this step can efficiently extract fat-soluble active ingredients that promote blood circulation and remove blood stasis, such as ferulic acid in Angelica sinensis, safflower yellow pigment in safflower and dragon's blood glycoside in dragon's blood.

[0030] (2) Water extraction: Take honeysuckle, forsythia, astragalus and bletilla striata, crush them, pass them through a 60-mesh sieve, add 10-12 times the weight of distilled water, decoct and extract twice at 90-100℃, each time for 1.5-2 hours, combine the two water extracts, filter, and concentrate under reduced pressure to a water extract concentrate with a relative density of 1.05-1.10 (60℃) for later use; this step can fully extract the water-soluble effective components of clearing heat and detoxifying, invigorating qi and promoting tissue regeneration, such as chlorogenic acid in honeysuckle, forsythoside in forsythia, astragaloside A in astragalus, and bletilla polysaccharide in bletilla striata.

[0031] (3) Ultrasonic dispersion: Mix the above-mentioned alcohol extract concentrate and water extract concentrate, add an appropriate amount of distilled water to dilute, place in an ultrasonic device, and ultrasonically disperse for 30-40 minutes at a power of 200-300W and a temperature of 30-40℃, stirring once every 10 minutes during the process. After ultrasonication, filter to obtain the extract of effective components of traditional Chinese medicine. Ultrasonic dispersion can make the effective components in the two extracts fully mixed and uniform, avoid the aggregation of effective components, and ensure the uniformity of subsequent drug release.

[0032] Preparation of composite film agents To address the issues of poor adhesion and insufficient stability in existing films, this invention selects polyvinyl alcohol-bletilla spores as the composite film-forming material, and combines it with glycerin as a plasticizer and polysorbate-80 as an emulsifier to prepare the film. The specific steps are as follows: (1) Dissolution of composite film-forming material: Take 10-15 parts of polyvinyl alcohol and 5-8 parts of Bletilla striata gum, add 80-100 parts of distilled water, stir and dissolve in a water bath at 70-80℃ to form a uniform film-forming material solution; polyvinyl alcohol has good film-forming properties and high mechanical strength, but weak adhesion. Bletilla striata gum has excellent bioadhesion and tissue regeneration effect. The combination of the two can achieve complementary advantages, improve the adhesion performance of the film agent to the wound, and enhance the tissue regeneration effect.

[0033] (2) Addition and mixing of excipients: Add 3-5 parts of glycerol and 1-2 parts of polysorbate-80 to the above film-forming material solution and stir evenly. Glycerol can increase the flexibility of the film and prevent the film from cracking after drying. Polysorbate-80 can promote the dissolution and dispersion of the effective components of traditional Chinese medicine in the film-forming material and further ensure the uniformity of drug release.

[0034] (3) Film Forming: Slowly add the extract of the effective components of traditional Chinese medicine prepared in step 3.2.2 to the above mixed solution and stir evenly to obtain the film stock solution; place the film stock solution on a flat glass plate, coat it with a thickness of 0.2-0.3 mm, dry it in a vacuum drying oven at 40-50℃ for 2-3 hours, take it out and peel it off, cut it into film of appropriate size, and thus obtain the traditional Chinese medicine film-coated tissue repair agent for treating diabetic foot ulcers.

[0035] The following are several specific embodiments of the application of the present invention. Example 1:

[0036] A traditional Chinese medicine coating for treating diabetic foot ulcers, the preparation steps of which are as follows: (1) Combination of Chinese medicinal materials: Select 6 parts of blood dragon, 11 parts of angelica, 16 parts of honeysuckle, 13 parts of forsythia, 9 parts of safflower, 18 parts of astragalus, and 11 parts of bletilla, and set aside.

[0037] (2) Gradient extraction: ① Alcohol extraction: Angelica sinensis, safflower, and dragon's blood were pulverized, passed through an 80-mesh sieve, and 8.5 times their weight of 72% ethanol solution were added. The mixture was refluxed twice at 62℃ for 2.2 hours each time. The alcohol extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.11 at 60℃. ② Water extraction: Lonicera japonica, forsythia suspensa, Astragalus membranaceus, and Bletilla striata were pulverized, passed through a 60-mesh sieve, and 10.5 times their weight of distilled water were added. The mixture was decocted twice at 92℃ for 1.6 hours each time. The water extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.06 at 60℃. ③ Ultrasonic dispersion: The alcohol and water extracts were mixed, diluted with an appropriate amount of distilled water, and placed in a 220W ultrasonic device. The mixture was ultrasonically dispersed at 32℃ for 32 minutes, with stirring every 10 minutes. The mixture was then filtered to obtain the extract of the effective components of the Chinese herbal medicine.

[0038] (3) Preparation of composite film: ① Dissolution of film-forming material: Take 11 parts of polyvinyl alcohol and 5.5 parts of Bletilla striata gum, add 85 parts of distilled water, stir and dissolve in a water bath at 72℃ to form a film-forming material solution; ② Addition of excipients: Add 3.5 parts of glycerol and 1.2 parts of polysorbate-80 to the film-forming material solution and stir evenly; ③ Film forming: Slowly add the extract of the effective components of traditional Chinese medicine to the mixed solution and stir evenly to obtain the film stock solution; Coat the film stock solution on a flat glass plate with a coating thickness of 0.22 mm, dry in a vacuum drying oven at 42℃ for 2.2 h, peel off and cut into 4 cm × 6 cm film to obtain the film. Example 2:

[0039] A traditional Chinese medicine coating for treating diabetic foot ulcers, the preparation steps of which are as follows: (1) Combination of Chinese medicinal materials: Select 8 parts of blood dragon, 13 parts of angelica, 19 parts of honeysuckle, 16 parts of forsythia, 11 parts of safflower, 22 parts of astragalus, and 14 parts of bletilla, and set aside.

[0040] (2) Gradient extraction: ① Alcohol extraction: Angelica sinensis, safflower, and dragon's blood were pulverized, passed through an 80-mesh sieve, and 9.5 times their weight of 78% ethanol solution were added. The mixture was refluxed twice at 68℃ for 2.8 hours each time. The alcohol extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.14 at 60℃. ② Water extraction: Lonicera japonica, forsythia suspensa, Astragalus membranaceus, and Bletilla striata were pulverized, passed through a 60-mesh sieve, and 11.5 times their weight of distilled water were added. The mixture was decocted twice at 98℃ for 1.9 hours each time. The water extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.09 at 60℃. ③ Ultrasonic dispersion: The alcohol and water extracts were mixed, diluted with an appropriate amount of distilled water, and placed in a 280W ultrasonic device. The mixture was ultrasonically dispersed at 38℃ for 38 minutes, with stirring every 10 minutes. The mixture was then filtered to obtain the extract of the effective components of the Chinese herbal medicine.

[0041] (3) Preparation of composite film: ① Dissolution of film-forming material: Take 14 parts of polyvinyl alcohol and 7.5 parts of Bletilla striata gum, add 95 parts of distilled water, stir and dissolve in a water bath at 78℃ to form a film-forming material solution; ② Addition of excipients: Add 4.5 parts of glycerol and 1.8 parts of polysorbate-80 to the film-forming material solution and stir evenly; ③ Film forming: Slowly add the extract of the effective components of traditional Chinese medicine to the mixed solution and stir evenly to obtain the film stock solution; Coat the film stock solution on a flat glass plate with a coating thickness of 0.28 mm, dry in a vacuum drying oven at 48℃ for 2.8 h, peel off and cut into 6 cm × 6 cm film to obtain the film.

[0042] 4.6 Example 6 A traditional Chinese medicine coating for treating diabetic foot ulcers, the preparation steps of which are as follows: (1) Combination of Chinese medicinal materials: Select 9 parts of blood dragon, 14 parts of angelica, 17 parts of honeysuckle, 17 parts of forsythia, 10.5 parts of safflower, 23 parts of astragalus, and 13 parts of bletilla, and set aside.

[0043] (2) Gradient extraction: ① Alcohol extraction: Angelica sinensis, safflower, and dragon's blood were pulverized, passed through an 80-mesh sieve, and 9.2 times their weight of 76% ethanol solution were added. The mixture was refluxed twice at 66℃ for 2.6 hours each time. The alcohol extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.13 at 60℃. ② Water extraction: Lonicera japonica, forsythia suspensa, Astragalus membranaceus, and Bletilla striata were pulverized, passed through a 60-mesh sieve, and 11.2 times their weight of distilled water were added. The mixture was decocted twice at 96℃ for 1.7 hours each time. The water extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.07 at 60℃. ③ Ultrasonic dispersion: The alcohol and water extracts were mixed, diluted with an appropriate amount of distilled water, and placed in a 260W ultrasonic device. The mixture was ultrasonically dispersed at 36℃ for 36 minutes, with stirring every 10 minutes. The mixture was then filtered to obtain the extract of the effective components of the Chinese herbal medicine.

[0044] (3) Preparation of composite film: ① Dissolution of film-forming material: Take 13 parts of polyvinyl alcohol and 6.5 parts of Bletilla striata gum, add 92 parts of distilled water, stir and dissolve in a water bath at 76℃ to form a film-forming material solution; ② Addition of excipients: Add 4.2 parts of glycerol and 1.6 parts of polysorbate-80 to the film-forming material solution and stir evenly; ③ Film forming: Slowly add the extract of the effective components of traditional Chinese medicine to the mixed solution and stir evenly to obtain the film stock solution; Coat the film stock solution on a flat glass plate with a coating thickness of 0.26 mm, dry in a vacuum drying oven at 46℃ for 2.6 h, peel off and cut into 5 cm × 6 cm film to obtain the film. Example 3:

[0045] A traditional Chinese medicine coating for treating diabetic foot ulcers, the preparation steps of which are as follows: (1) Combination of Chinese herbal raw materials: Select 5.5 parts of blood dragon, 10.5 parts of angelica, 20 parts of honeysuckle, 14 parts of forsythia, 8.5 parts of safflower, 16 parts of astragalus, and 10.5 parts of bletilla, and set aside.

[0046] (2) Gradient extraction: ① Alcohol extraction: Angelica sinensis, safflower, and dragon's blood were pulverized, passed through an 80-mesh sieve, and 8.8 times their weight of 71% ethanol solution were added. The mixture was refluxed twice at 61℃ for 2.1 h each time. The alcohol extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.105 at 60℃. ② Water extraction: Lonicera japonica, forsythia suspensa, Astragalus membranaceus, and Bletilla striata were pulverized, passed through a 60-mesh sieve, and 10.8 times their weight of distilled water were added. The mixture was decocted twice at 91℃ for 1.55 h each time. The water extracts were combined, filtered, and concentrated under reduced pressure to a concentration of 1.055 at 60℃. ③ Ultrasonic dispersion: The alcohol and water extracts were mixed, diluted with an appropriate amount of distilled water, and placed in a 210W ultrasonic device. The mixture was ultrasonically dispersed at 31℃ for 31 min, with stirring every 10 min. The mixture was then filtered to obtain the extract of the effective components of the Chinese herbal medicine.

[0047] (3) Preparation of composite film: ① Dissolution of film-forming material: Take 10.5 parts of polyvinyl alcohol and 5.2 parts of Bletilla striata gum, add 82 parts of distilled water, stir and dissolve in a water bath at 71℃ to form a film-forming material solution; ② Addition of excipients: Add 3.2 parts of glycerol and 1.1 parts of polysorbate-80 to the film-forming material solution and stir evenly; ③ Film forming: Slowly add the extract of the effective components of traditional Chinese medicine to the mixed solution and stir evenly to obtain the film stock solution; Coat the film stock solution on a flat glass plate with a coating thickness of 0.21 mm, dry in a vacuum drying oven at 41℃ for 2.1 h, peel off and cut into 4 cm × 4 cm film to obtain the film. Example 4:

[0048] A traditional Chinese medicine coating for treating diabetic foot ulcers, the preparation steps of which are as follows: (1) Combination of Chinese herbal raw materials: Select 7 parts of blood dragon, 12 parts of angelica, 18 parts of honeysuckle, 15 parts of forsythia, 10 parts of safflower, 20 parts of astragalus, and 12 parts of bletilla, and set aside.

[0049] (2) Gradient extraction: ① Alcohol extraction: Take Angelica sinensis, Carthamus tinctorius and Dracaena cochinchinensis, crush them, pass them through an 80-mesh sieve, add 9 times the weight of 75% ethanol solution, and reflux extract twice at 65℃ for 2.5h each time. Combine the alcohol extracts, filter, and concentrate under reduced pressure to a concentrated alcohol extract with a relative density of 1.12 (60℃); ② Water extraction: Take Lonicera japonica, Forsythia suspensa, Astragalus membranaceus and Bletilla striata, crush them, pass them through a 60-mesh sieve, add 11 times the weight of distilled water, and decoct at 95℃ for 1.8h each time. Combine the water extracts, filter, and concentrate under reduced pressure to a concentrated water extract with a relative density of 1.08 (60℃); ③ Ultrasonic dispersion: Mix the concentrated alcohol extract and the concentrated water extract, add an appropriate amount of distilled water to dilute, place in a 250W ultrasonic device, and ultrasonically disperse at 35℃ for 35min, stirring once every 10min. Filter to obtain the extract of effective components of traditional Chinese medicine.

[0050] (3) Preparation of composite film: ① Dissolution of film-forming material: Take 12 parts of polyvinyl alcohol and 6 parts of Bletilla striata gum, add 90 parts of distilled water, stir and dissolve in a water bath at 75℃ to form a film-forming material solution; ② Addition of excipients: Add 4 parts of glycerol and 1.5 parts of polysorbate-80 to the film-forming material solution and stir evenly; ③ Film forming: Slowly add the extract of the effective components of traditional Chinese medicine to the mixed solution and stir evenly to obtain the film stock solution; Coat the film stock solution on a flat glass plate with a coating thickness of 0.25 mm, dry in a vacuum drying oven at 45℃ for 2.5 h, peel off and cut into 5 cm × 5 cm film to obtain the film.

[0051] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine coating for treating diabetic foot ulcers, characterized in that, It is prepared from Chinese medicinal materials and excipients. The Chinese medicinal materials are as follows by weight: 5-10 parts of dragon's blood, 10-15 parts of angelica, 15-20 parts of honeysuckle, 12-18 parts of forsythia, 8-12 parts of safflower, 15-25 parts of astragalus, and 10-15 parts of bletilla. The excipients are as follows by weight: 10-15 parts of polyvinyl alcohol, 5-8 parts of bletilla gum, 3-5 parts of glycerin, 2 parts of polysorbate-801, and 80-100 parts of distilled water.

2. A method for preparing a traditional Chinese medicine coating for treating diabetic foot ulcers, characterized in that, Includes the following steps: (1) Gradient extraction: Angelica sinensis, safflower and dragon's blood were extracted by alcohol extraction, while honeysuckle, forsythia, astragalus and bletilla were extracted by water extraction. The alcohol extract and water extract were combined and then ultrasonically dispersed to obtain the extract of effective components of traditional Chinese medicine. (2) Composite film formation: Polyvinyl alcohol and Bletilla striata gum are dissolved in distilled water, glycerin and polysorbate-80 are added in sequence and stirred evenly, and then the extract of the effective components of the Chinese medicine is added and mixed. After coating, drying, peeling and cutting, a film is obtained.

3. The repair agent according to claim 1, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: 7 parts of dragon's blood, 12 parts of angelica sinensis, 18 parts of honeysuckle, 15 parts of forsythia suspensa, 10 parts of safflower, 20 parts of astragalus membranaceus, and 12 parts of bletilla striata.

4. The preparation method according to claim 2, characterized in that, The conditions for the alcohol extraction process described in step (1) are as follows: Angelica sinensis, safflower, and dragon's blood are pulverized and passed through an 80-mesh sieve. 8-10 times their weight of 70%-80% ethanol solution is added, and the mixture is refluxed twice at 60-70℃ for 2-3 hours each time. The alcohol extracts are combined, filtered, and concentrated under reduced pressure to a concentrated alcohol extract with a relative density of 1.10-1.15 at 60℃.

5. The preparation method according to claim 2, characterized in that, The conditions for the water extraction process described in step (1) are as follows: honeysuckle, forsythia, astragalus, and bletilla are pulverized and passed through a 60-mesh sieve. 10-12 times the weight of distilled water is added, and the mixture is decocted and extracted twice at 90-100℃ for 1.5-2 hours each time. The water extracts are combined, filtered, and concentrated under reduced pressure to a water extract concentrate with a relative density of 1.05-1.10 at 60℃.

6. The preparation method according to claim 2, characterized in that, The conditions for ultrasonic dispersion in step (1) are: power 200-300W, temperature 30-40℃, ultrasonic dispersion for 30-40min, stirring once every 10min during the process, and filtering after ultrasonic dispersion to obtain the extract of the effective components of the Chinese medicine.

7. The preparation method according to claim 2, characterized in that, The dissolution conditions for polyvinyl alcohol and Bletilla striata gum in step (2) are: stirring and dissolving in a water bath at 70-80℃ to form a uniform film-forming material solution; the coating thickness is 0.2-0.3mm, and the drying conditions are vacuum drying at 40-50℃ for 2-3h.

8. The repair agent according to claim 1, characterized in that, The weight ratio of the excipients is as follows: 12 parts polyvinyl alcohol, 6 parts Bletilla striata gum, 4 parts glycerin, 1.5 parts polysorbate-80, and 90 parts distilled water.

9. The preparation method according to claim 2, characterized in that, The volume ratio of the extract of effective components of traditional Chinese medicine to the film-forming material solution in step (2) is 1:3-1:

5.

10. The application of the repair agent according to claim 1 in the preparation of a topical formulation for treating diabetic foot ulcers, characterized in that, The repair agent is suitable for diabetic foot ulcer wounds that require a step-by-step repair process of "debridement-blood circulation-tissue regeneration".

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