Traditional Chinese medicine composition for promoting healing of burn wounds, preparation method and application thereof

Abstract

This invention provides a traditional Chinese medicine composition for promoting burn wound healing, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition comprises the following components in parts by weight: 15-20 parts of Cnidium monnieri; 20-40 parts of Sargentodoxa cuneata; 20-40 parts of Taraxacum mongolicum; 20-40 parts of Polygonum cuspidatum; 25-30 parts of Phellodendron chinense; 25-30 parts of Sophora flavescens; 10-15 parts of Galla chinensis; 1-5 parts of a temperature-controlled release agent; and 1-5 parts of mucopolysaccharide. The temperature-controlled release agent includes menthol glycoside, tris(hydroxymethyl)aminomethane, and sodium alginate. This invention uses Cnidium monnieri, Sargentodoxa cuneata, Taraxacum mongolicum, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens, and Galla chinensis to form a traditional Chinese medicine composition. This composition possesses anti-inflammatory, antibacterial, healing-promoting, astringent, and analgesic effects. Combined with the temperature-controlled release agent and mucopolysaccharide, it effectively regulates the temperature required for fumigation while promoting the efficacy of the medicine, avoiding secondary damage to the wound due to improper temperature control.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a traditional Chinese medicine composition for promoting burn wound healing, its preparation method, and its application. Background Technology

[0002] Burns refer to tissue damage caused by heat, electric current, chemicals, lasers, radiation, etc. Burns manifest as redness, swelling, blisters, exudation, eschar, pain or loss of sensation. When a burn occurs, the integrity of the skin or mucous membrane is disrupted, forming an open wound. Therefore, promoting wound healing is key to the treatment outcome.

[0003] Among the many methods for treating burns, traditional Chinese medicine fumigation and washing is a traditional external treatment method that combines the effects of medicine and heat, and is widely used during the recovery period. Traditional Chinese medicine fumigation and washing involves two steps: first, the wound is fumigated with herbal steam; then, when the temperature drops to 40℃~42℃, the wound is rinsed or soaked with herbal liquid. During fumigation and washing, the medicine can act directly on the wound, resulting in significant therapeutic effects on local lesions. Simultaneously, the heat effect promotes blood circulation and accelerates wound healing. Compared to oral medications, traditional Chinese medicine fumigation and washing eliminates the first-pass effect caused by absorption through the digestive tract. Compared to direct topical application of medications, traditional Chinese medicine fumigation and washing does not require regular dressing changes, reducing secondary damage caused by drug adhesion.

[0004] However, to maximize the effectiveness of fumigation, the temperature of the herbal solution needs to be maintained at 40℃~42℃, or even higher. However, improper temperature control can easily lead to burns or irritation of the wound. Therefore, in many clinical settings, when using herbal fumigation to treat burns, it is necessary to simultaneously monitor various patient indicators, such as blood pressure, heart rate, and blood oxygen levels. Furthermore, the fumigation time is generally short, limiting the effectiveness of the herbal medicine. Summary of the Invention

[0005] Therefore, the present invention aims to provide a traditional Chinese medicine composition for promoting the healing of burn wounds, its preparation method and application, in order to solve at least one technical problem in the background art.

[0006] This invention is implemented as follows:

[0007] The first aspect of this invention provides a method for preparing a traditional Chinese medicine composition that promotes the healing of burn wounds. The traditional Chinese medicine composition comprises the following components in parts by weight: 15-20 parts of Cnidium monnieri; 20-40 parts of Sargentodoxa cuneata; 20-40 parts of Taraxacum mongolicum; 20-40 parts of Polygonum cuspidatum; 25-30 parts of Phellodendron chinense; 25-30 parts of Sophora flavescens; 10-15 parts of Galla chinensis; 1-5 parts of a temperature-controlled release agent; and 1-5 parts of mucopolysaccharide.

[0008] The temperature-controlled release agents include menthol glycosides, tris(hydroxymethyl)aminomethane, and sodium alginate;

[0009] The preparation method includes the following steps:

[0010] Cnidium monnieri, red vine, dandelion, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens and Galla chinensis are mixed in proportion, boiled with water and decocted until the liquid is concentrated to 1 / 5 to 1 / 2 to obtain the original liquid, or freeze-dried to obtain freeze-dried powder.

[0011] Then add a temperature-release agent and mucopolysaccharide, and mix to obtain the traditional Chinese medicine composition.

[0012] Furthermore, according to the mass ratio, in the temperature-release agent, menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = (5~10):(1~2):1.

[0013] Furthermore, according to the mass ratio, in the temperature-controlled release agent, the ratio of menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate is 5:1.5:1.

[0014] Furthermore, the mucopolysaccharide is at least one of yam polysaccharide and snail polysaccharide.

[0015] Furthermore, the mucopolysaccharide is a mixture of yam polysaccharide and snail polysaccharide; the mass ratio of yam polysaccharide to snail polysaccharide is 0.5~2:1.

[0016] Furthermore, before mixing, the gallnuts undergo pretreatment, specifically including:

[0017] The gallnuts were soaked in an organic weak acid solution for 30 to 60 minutes; the organic weak acid solution was citric acid, acetic acid, or malic acid, with a mass concentration of 1% to 2%.

[0018] After removing them from the oven, rinse them and bake them at a low temperature of 60℃~80℃ for 10 to 15 minutes, until the surface turns slightly yellow.

[0019] It is crushed into 80-100 mesh particles.

[0020] Furthermore, before mixing, the red vine undergoes pretreatment, specifically including:

[0021] Cut the red vine into thin slices of 2mm to 5mm;

[0022] Soak the slices of *Rhizoma Scutellariae* in a sodium bicarbonate solution with a mass concentration of 0.1% to 1% for 10 to 20 minutes;

[0023] After removing, rinse and dry, then spray the surface of the red rattan slices evenly with a 50%~70% ethanol solution and let it moisten for 1~2 hours;

[0024] Bake at a low temperature of 50-60℃ for 20-40 minutes.

[0025] The second aspect of the present invention provides a traditional Chinese medicine composition for promoting the healing of burn wounds prepared by the above preparation method.

[0026] A third aspect of this invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug that promotes the healing of burn wounds.

[0027] Furthermore, the method of using the drug is fumigation and washing.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] 1. This invention is a traditional Chinese medicine composition made from Cnidium monnieri, Sargentodoxa cuneata, Taraxacum mongolicum, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens, and Galla chinensis. It has anti-inflammatory, antibacterial, healing-promoting, astringent, and analgesic effects. Combined with a temperature-controlled release agent and mucopolysaccharide, it can effectively regulate the temperature required for fumigation and washing while promoting its efficacy, thus avoiding secondary damage to the wound due to improper temperature control.

[0030] 2. In this invention, Cnidium monnieri, Sargentodoxa cuneata, Taraxacum mongolicum, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens, and Galla chinensis work synergistically to enhance their anti-inflammatory and antibacterial effects, while also mitigating the adverse effects of the principal herbs.

[0031] 3. The traditional Chinese medicine composition of the present invention also incorporates a temperature-controlled release agent composed of menthol glycoside, tris(hydroxymethyl)aminomethane, and sodium alginate to construct a mild temperature-responsive sustained-release system, which can reduce the temperature of traditional Chinese medicine fumigation by 2°C to 3°C.

[0032] 4. The menthol glycosides in the temperature-release agent of the present invention have the characteristics of good water solubility and release of free menthol upon hydrolysis. When the liquid is heated, it can accelerate the hydrolysis of menthol glycosides and trigger further release of menthol, thereby driving the drug to volatilize and come into contact with the wound during fumigation; it can also bring a cooling sensation and relieve the discomfort of the wound caused by the fumigation temperature; menthol glycosides overcome the problem of poor water solubility of natural menthol.

[0033] 5. The tris(hydroxymethyl)aminomethane in the temperature-release agent of the present invention can regulate endothermic and exothermic reactions. Tris(hydroxymethyl)aminomethane can generate a controllable exothermic effect on the wound surface through a proton transfer reaction, thereby promoting microcirculation. It can promote a slight increase in the temperature of the wound surface without the need for high-temperature drug solution, which can dilate blood vessels, increase local blood flow and oxygen supply, and accelerate the resolution of inflammation and the formation of granulation tissue. In addition, tris(hydroxymethyl)aminomethane and menthol glycosides synergistically trigger drug release.

[0034] 6. The sodium alginate in the temperature-release agent of the present invention can inhibit the excessive exothermic reaction of tris(hydroxymethyl)aminomethane, thus avoiding the aggravation of inflammatory response or cell damage; at the same time, it forms a hydrogel on the wound surface, promotes hydration of the stratum corneum, expands the intercellular spaces of keratinocytes, enhances the penetration of hydrophilic Chinese medicine components, and regulates the rate of menthol release from the hydrolysis of menthol glycosides.

[0035] 7. The present invention adds a trace amount of mucopolysaccharide to the traditional Chinese medicine composition, which forms a protective barrier on the skin surface, increases the residence time of the active ingredients of the traditional Chinese medicine on the wound, and promotes the efficacy of the medicine; and utilizes the antioxidant properties of the mucopolysaccharide itself to further promote wound healing.

[0036] 8. The present invention pre-treats gallnut and red vine before decoction to improve the dissolution rate of tannic acid, the main medicinal component in gallnut; and promotes the simultaneous dissolution of water-soluble and fat-soluble components in red vine during decoction, so as to better exert the efficacy of the drug. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0038] The traditional Chinese medicine composition for promoting burn wound healing of the present invention comprises the following components in parts by weight: 15-20 parts of Cnidium monnieri; 20-40 parts of Sargentodoxa cuneata; 20-40 parts of Taraxacum mongolicum; 20-40 parts of Polygonum cuspidatum; 25-30 parts of Phellodendron chinense; 25-30 parts of Sophora flavescens; and 10-15 parts of Galla chinensis. Preferably, the composition comprises 18 parts of Cnidium monnieri; 30 parts of Sargentodoxa cuneata; 30 parts of Taraxacum mongolicum; 30 parts of Polygonum cuspidatum; 27 parts of Phellodendron chinense; 27 parts of Sophora flavescens; and 12 parts of Galla chinensis. However, the composition is not limited to the listed component values, and other unlisted values ​​within the range are also applicable.

[0039] The mechanism of action of this traditional Chinese medicine composition in treating burn wounds is mainly based on its multiple pharmacological activities, such as anti-inflammatory, antibacterial, healing-promoting, astringent, and analgesic effects, which are in line with the traditional Chinese medicine treatment principle of "clearing heat and toxins, resolving dampness and blood stasis, promoting tissue regeneration and wound healing".

[0040] In this invention, the principal herbs are Phellodendron bark and Sophora flavescens, which function to clear heat and dry dampness, detoxify and heal sores. Phellodendron bark (whose main active ingredient is berberine) and Sophora flavescens (whose main active ingredient is matrine) can strongly inhibit bacterial infection of wounds and reduce inflammatory reactions. The assistant herbs are Polygonum cuspidatum, Taraxacum mongolicum, and Cnidium monnieri. Polygonum cuspidatum and Taraxacum mongolicum assist in clearing heat and detoxifying, while also promoting blood circulation, removing blood stasis, reducing swelling and draining pus. Emodin in Polygonum cuspidatum promotes microcirculation in the wound, and dandelion polysaccharides accelerate tissue repair. Cnidium monnieri has the effects of drying dampness, killing parasites, promoting tissue regeneration and relieving pain. Its active ingredient (osthol) promotes epithelial cell proliferation, inhibits fungal infection, and effectively improves dampness and turbidity in sores and pain after burns. The adjuvant herbs are gallnut and red vine. Gallnut can astringe and stop bleeding, reduce exudation, and prevent the retention of dampness and toxins in the wound. Its active ingredient (tannic acid) forms a protein film to protect the wound, avoiding excessive inflammation and damage, and also harmonizes the bitter and cold nature of the principal herb to prevent it from harming the body's vital energy. Red vine invigorates blood circulation and unblocks the meridians, preventing local blood stasis after burns. Its active ingredient (flavonoids) improves microcirculation and promotes drug penetration. In addition, dandelion and red vine also serve as guiding herbs, directing the medicinal power directly to the affected area. The polysaccharide components of dandelion can enhance local drug retention, while red vine invigorates blood circulation and unblocks the meridians, together guiding the other herbs to the wound.

[0041] Because burn wounds are characterized by abundant necrotic tissue, disrupted microcirculation, significant inflammatory response, and high risk of infection, more meticulous wound management is required. This invention utilizes a traditional Chinese medicine composition consisting of Cnidium monnieri, Sargentodoxa cuneata, Taraxacum mongolicum, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens, and Galla chinensis, which can effectively promote wound healing. However, in actual fumigation and washing operations, a higher temperature (e.g., 40℃~42℃) is needed to maximize the efficacy of the medicine. For some patients with weaker constitutions or severe burns, high-temperature stimulation can easily cause secondary damage to the wound, thus hindering wound healing. Furthermore, the medicinal solution stays on the wound for a short time during fumigation and washing. To address these issues, the traditional Chinese medicine composition of this invention also includes 1 to 5 parts of a temperature-sustaining agent and 1 to 5 parts of mucopolysaccharide; preferably, 3 parts of the temperature-sustaining agent and 3 parts of the mucopolysaccharide. The temperature-release agent includes menthol glycoside, tris(hydroxymethyl)aminomethane, and sodium alginate, with a mass ratio of menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = (5~10):(1~2):1; the mucopolysaccharide is at least one of yam polysaccharide and snail polysaccharide.

[0042] This temperature-controlled release agent can serve as a mild, temperature-responsive sustained-release system. Menthol glycosides are the core component, a class of compounds formed by the glycosidic bond between menthol and a glycosyl group. Glycosidic bonds are temperature-sensitive and possess characteristics such as good water solubility and the release of free menthol upon hydrolysis, thus exhibiting a certain degree of volatility. Heating the liquid accelerates the hydrolysis of menthol glycosides, triggering further release of menthol, which then evaporates during fumigation and comes into contact with the wound. Furthermore, the temperature-controlled release agent provides a cooling sensation, alleviating discomfort caused by the fumigation temperature. Menthol glycosides overcome the poor water solubility of natural menthol and enhance the transdermal absorption of traditional Chinese medicine components. Menthol glycosides can be commercially available or synthesized in-house, such as using a glycosyltransferase (UGT) catalytic method, where UDP-glycosyltransferase (UGT) catalyzes the reaction of menthol with UDP-glucose to produce menthol glycosides. This synthesis process is existing technology and is not limited here.

[0043] Tris(hydroxymethyl)aminomethane is a commonly used pH buffer system, but in the temperature-controlled release agent of this invention, it is used to regulate endothermic and exothermic reactions. Tris(hydroxymethyl)aminomethane can produce a controllable exothermic effect locally on the wound surface through a proton transfer reaction. This is because the amino group in the weakly basic tris(hydroxymethyl)aminomethane molecule can accept protons (H+). + ) forms positively charged ammonium ions (NH3) + The wound exudate contains a high amount of acid, resulting in a weakly acidic pH. When tris(hydroxymethyl)aminomethane comes into contact with the acidic exudate on the wound surface, some of the Tris-NH3... + It will release H + Deprotonation generates local heat, thereby promoting microcirculation. It can promote a slight increase in the temperature of the wound surface without the need for high-temperature drug solutions. It can dilate blood vessels, increase local blood flow and oxygen supply, and accelerate the resolution of inflammation and the formation of granulation tissue. In addition, the synergistic effect of tris(hydroxymethyl)aminomethane and menthol glycosides triggers drug release.

[0044] In the temperature-controlled release agent of the present invention, the role of sodium alginate is: (1) to avoid excessive heat release of tris(hydroxymethyl)aminomethane, which can act as a heat dissipation carrier for tris(hydroxymethyl)aminomethane, and use water evaporation to dissipate heat, thereby avoiding aggravation of inflammatory response or cell damage; (2) sodium alginate is a natural polysaccharide that can form a hydrogel on the wound surface, promote hydration of the stratum corneum, expand the intercellular space of keratinocytes, and enhance the penetration of hydrophilic Chinese medicine components (such as flavonoids and alkaloids); (3) sodium alginate can also regulate the rate of menthol release by hydrolysis of menthol glycosides.

[0045] The reason for adding mucopolysaccharides to the traditional Chinese medicine composition in this invention is as follows: (1) A small amount of mucopolysaccharides can form a protective barrier on the skin surface, increasing the residence time of the active ingredients of traditional Chinese medicine on the wound and promoting the efficacy of the medicine; (2) It further promotes wound healing. For example, yam polysaccharides have an antioxidant effect, avoiding the overexpression of free radicals that leads to the deterioration of the inflammatory environment, protecting cells from oxidative damage, and thus promoting wound healing; snail polysaccharides enhance the body's defense function by activating immune cells such as macrophages, inhibiting inflammatory factors and clearing free radicals, stimulating the generation of collagen and elastic fibers, and accelerating wound healing. Among the mucopolysaccharides, the effect of the mixture of yam polysaccharides and snail polysaccharides is better than the effect of either one alone. In specific implementation, the two are mixed according to the ratio of yam polysaccharides to snail polysaccharides = 0.5~2:1 (mass ratio). In the following examples, a mass ratio of 1:1 is used to prepare the mucopolysaccharides, but it is not limited to the values ​​listed. Other unlisted values ​​within the range are also applicable.

[0046] Yam polysaccharides and snail polysaccharides can be purchased commercially or synthesized artificially. For example, yam polysaccharides are extracted using a fermentation and hot water extraction method with Lactobacillus plantarum; snail polysaccharides are obtained by protein denaturation and membrane filtration of snail mucus, or directly from the shelled snail body through defatting, enzymatic hydrolysis, dialysis, and chromatography. The synthesis processes for both are existing technologies and are not limited here.

[0047] The preparation method includes the following steps: Cnidium monnieri, red vine, dandelion, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens and Galla chinensis are mixed in proportion, boiled with water and decocted until the liquid is concentrated to 1 / 5 to 1 / 2 to obtain the original liquid, or freeze-dried to obtain freeze-dried powder; then a temperature-controlled release agent and mucopolysaccharide are added and mixed to obtain the traditional Chinese medicine composition.

[0048] In practice, the stock solution has a shorter shelf life and needs to be used promptly after decoction; the freeze-dried powder can be stored at specific low temperatures (such as -4℃) and has a longer shelf life. If the stock solution is used, the temperature-releasing agent and mucopolysaccharide can be added before use. For example, adjust the temperature of the stock solution to about 40℃, add the temperature-releasing agent and mucopolysaccharide, and mix well. If the freeze-dried powder is used, the temperature-releasing agent and mucopolysaccharide can be directly mixed with the solid powder, then stored at low temperature. When using, add water at about 40℃ to fully dissolve them.

[0049] In some preferred embodiments, the gallnut and red vine are pretreated because the main medicinal component of gallnut is tannic acid, which is not easily dissolved during decoction; the active components of red vine are more complex, including phenolic acids, flavonoids and glycosides, which have both water-soluble and fat-soluble components, making it difficult to effectively dissolve them simultaneously during decoction.

[0050] The specific steps of gallnut pretreatment include:

[0051] (1) Soak gallnut in organic weak acid solution for 30 min to 60 min; the organic weak acid solution is citric acid, acetic acid or malic acid, with a mass concentration of 1% to 2%; the purpose is to improve the stability of tannic acid in an acidic environment and prevent oxidative polymerization. At the same time, the acidity of organic weak acid is relatively weak, and the mild environment avoids denaturation of active ingredients.

[0052] (2) After taking it out, rinse it and bake the gallnut at a low temperature of 60℃~80℃ for 10min~15min until the surface is slightly yellow; the purpose of the low temperature baking is to destroy part of the cell wall structure and reduce the combination of tannic acid and protein.

[0053] (3) Crush into 80-100 mesh particles. The purpose is to increase the contact area with water during subsequent decoction and promote the dissolution of tannic acid.

[0054] The specific steps for pretreatment of red vine include:

[0055] (1) Cut red vine into 2mm~5mm thin slices; thereby increasing the surface area and promoting the simultaneous dissolution of water-soluble and fat-soluble components during subsequent decoction, while also benefiting the treatment effect of soaking and moistening reagents during pretreatment;

[0056] (2) Soak the slices of red vine in sodium bicarbonate solution for 10 min to 20 min; the mass concentration of sodium bicarbonate solution is 0.1% to 1%; the weakly alkaline environment created by sodium bicarbonate can hydrolyze some glycosides to generate aglycones that are more easily absorbed.

[0057] (3) After taking it out, rinse and dry it. Spray the surface of the red vine slices evenly with an ethanol solution of 50%~70% by volume and let it moisten for 1h~2h. Ethanol can extract fat-soluble components.

[0058] (4) Bake at a low temperature of 50℃~60℃ for 20min~40min to reduce the amount of water that is encapsulated by the active ingredients due to soaking and moistening, and promote the release of active ingredients after heat treatment.

[0059] The traditional Chinese medicine composition prepared by this invention can be used directly as a drug to promote the healing of burn wounds, or it can be mixed with other excipients permitted in the art to prepare a drug to promote the healing of burn wounds.

[0060] The medication is administered via fumigation or washing, but other methods of administration, such as iontophoresis, may also be used.

[0061] Example 1

[0062] A method for preparing a traditional Chinese medicine composition that promotes burn wound healing, comprising the following steps:

[0063] S1. Weigh out 18g of Cnidium monnieri, 30g of Sargentodoxa cuneata, 30g of Taraxacum mongolicum, 30g of Polygonum cuspidatum, 27g of Phellodendron chinense, 27g of Sophora flavescens, and 12g of Galla chinensis, and slice or crush them into granules; weigh out 3g of temperature-release agent and 3g of Dioscorea opposita polysaccharide; in the temperature-release agent, the mass ratio is menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = 5:1:1;

[0064] S2, Cnidium monnieri, Sargentodoxa cuneata, Taraxacum mongolicum, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens and Galla chinensis are mixed in proportion, 3L of water is added and boiled until the decoction is concentrated to 1L to obtain the original liquid. After cooling, temperature-release agent and mucopolysaccharide are added and stirred evenly to obtain the traditional Chinese medicine composition.

[0065] Example 2

[0066] Based on Example 1, this example replaces yam polysaccharide with snail polysaccharide, while other conditions and steps are the same as in Example 1.

[0067] Example 3

[0068] Based on Example 1, this example replaces yam polysaccharide with an equal amount of snail polysaccharide and yam polysaccharide, while other conditions and steps are the same as in Example 1.

[0069] Example 4

[0070] Based on Example 1, this example pre-treats gallnut and red vine before step S2, while other conditions and steps are the same as in Example 1.

[0071] The specific steps of the gallnut pretreatment include: soaking the gallnuts in a 1% malic acid solution for 50 minutes; rinsing them after removal; baking the gallnuts at a low temperature of 60℃~80℃ for 10 minutes until the surface turns slightly yellow; crushing them and passing them through an 80-mesh sieve to obtain gallnut particles.

[0072] The specific steps for pretreatment of red vine include: cutting red vine into thin slices of about 3 mm; soaking the red vine slices in a 0.5% sodium bicarbonate solution for 15 minutes; rinsing and drying them after soaking; spraying the surface of the red vine slices evenly with a 70% ethanol solution and allowing them to moisten for 1 hour; and baking them at a low temperature of 50℃~60℃ for 30 minutes.

[0073] Example 5

[0074] Based on Example 1, this example adjusts the ratio of each component of the temperature-release agent, specifically menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = 5:1.5:1, while other conditions and steps are the same as in Example 1.

[0075] Example 6

[0076] Based on Example 1, this example adjusts the ratio of each component of the temperature-release agent, specifically menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = 5:2:1, while other conditions and steps are the same as in Example 1.

[0077] Example 7

[0078] Based on Example 1, this example adjusts the ratio of each component of the temperature-release agent, specifically menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = 8:1:1, while other conditions and steps are the same as in Example 1.

[0079] Example 8

[0080] Based on Example 1, this example adjusts the ratio of each component of the temperature-release agent, specifically menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = 10:1:1, while other conditions and steps are the same as in Example 1.

[0081] Comparative Example 1

[0082] Based on Example 1, this comparative example omits the temperature-controlled release agent, while all other conditions and steps remain the same as in Example 1.

[0083] Comparative Example 2

[0084] Based on Example 1, this comparative example omits yam polysaccharide, while other conditions and steps are the same as in Example 1.

[0085] Comparative Example 3

[0086] Based on Example 1, this comparative example omits the temperature-release agent and yam polysaccharide, while keeping all other conditions and steps the same as in Example 1.

[0087] Comparative Example 4

[0088] Based on Example 1, the temperature-release agent of this comparative example has menthol glycosides removed, while other conditions and steps are the same as in Example 1.

[0089] Comparative Example 5

[0090] Based on Example 1, the temperature-release agent of this comparative example has been modified by removing tris(hydroxymethyl)aminomethane, while all other conditions and steps are the same as in Example 1.

[0091] Comparative Example 6

[0092] Based on Example 1, sodium alginate was removed from the temperature-release agent in this comparative example, while other conditions and steps were the same as in Example 1.

[0093] I. In vitro antibacterial test

[0094] 1. Test drugs: The traditional Chinese medicine compositions prepared in Examples 1 to 8 and Comparative Examples 1 to 6 were used as test drugs for the treatment group.

[0095] 2. Test bacterial suspensions: Frozen Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, and Candida albicans were revived, passaged, and preserved (-80℃). Activation was performed under aseptic conditions, and then single colonies were picked and cultured in LB broth. A concentration of 1.0 × 10⁻⁶ was prepared using McFarland tubes. 5 A bacterial suspension of CFU / mL was prepared as the test bacterial solution.

[0096] 3. Antibacterial test: Using the filter paper disc method, 100 μL of test bacterial suspensions of Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, and Candida albicans were evenly spread onto nutrient agar plates. Paper discs containing the test drug were also attached to the plates. Sterile water was used as a blank control group. The petri dishes were incubated at 37℃ for 24 h, and each gradient was repeated three times. The diameter of the inhibition zone was measured, and the inhibition rate was calculated. The results are shown in Table 1.

[0097] Antibacterial rate = (D CK -D SY ) / D CK D CK D SY The diameters of the inhibition zones were measured in antibacterial tests on sterile water and the test drug, respectively.

[0098] Table 1

[0099]

[0100] Note: Data in Table 1 are mean ± standard deviation. In the same column of data, groups with the same superscript letter indicate no significant difference between groups (P>0.05); groups with different superscript letters indicate significant difference between groups (P<0.05).

[0101] As shown in Table 1, the traditional Chinese medicine composition of the present invention has a high antibacterial effect against Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, and Candida albicans.

[0102] Comparing Examples 1 to 3, Comparative Example 2 and Comparative Example 3, the addition of yam polysaccharide and / or snail polysaccharide to the traditional Chinese medicine composition significantly improved the antibacterial effect.

[0103] Comparing Example 1 and Example 4, pretreatment of Gallnut and Red Vine before decoction increased the antibacterial effects against Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, and Candida albicans. The antibacterial effect on Candida albicans was the most significant, followed by Staphylococcus aureus and Streptococcus pyogenes, while the antibacterial effect on Pseudomonas aeruginosa was relatively weak.

[0104] Comparing Examples 1, 5 to 8, Comparative Examples 1, 4 to 6, removing any component from the temperature-release agent or adjusting its dosage had little effect on the antibacterial effect against Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, and Candida albicans.

[0105] II. Healing rate, scar thickness, and time to complete healing

[0106] 1. Test drugs: The traditional Chinese medicine compositions prepared in Examples 1 to 8 and Comparative Examples 1 to 6 were used as test drugs for the treatment group.

[0107] 2. Experimental subjects: SPF-grade male SD rats, weighing 200g ± 50g, were fed in an environment with a temperature of 25℃ ± 1℃, humidity of 70% ± 5%, and L / D of 12h / 12h, with sufficient food and water.

[0108] 3. Modeling, drug administration, and grouping: Rats were anesthetized intraperitoneally with 2% isoflurane, and the fur on their backs was shaved off. A 10mm diameter aluminum rod was heated to 100℃ and placed on the skin for 10 seconds to establish a rat burn model. The burn wounds were left untreated and designated as the model group. Different treatment groups were formed by fumigating the burn wounds with traditional Chinese medicine using the different experimental drugs mentioned above. Each group consisted of 5 rats and was treated repeatedly.

[0109] The fumigation and washing process is as follows: Mix the test drug with boiling water and pour it into a basin. First, use steam to fumigate the burn wound. When the temperature drops to about 38℃, directly soak and wash the affected area in the basin for 15 minutes, once in the morning and once in the evening.

[0110] 4. At 3, 7, 10, and 14 days after drug administration, the wound healing rate of rats in each group was measured, and the time to complete wound healing was recorded. After complete healing, the scar thickness was observed and measured under a microscope, and the results are recorded in Tables 2 and 3 below.

[0111] Wound healing rate = (S0 - S) t ) / S0; where S0 and S t These are the wound areas at the initial stage and during the initial detection, respectively.

[0112] Table 2

[0113]

[0114] Table 3

[0115]

[0116] Note: Data in Tables 2 and 3 are mean ± standard deviation. In the same column of data, groups with one or more identical superscript letters indicate no significant difference between groups (P>0.05); groups with no identical superscript letters indicate significant difference between groups (P<0.05).

[0117] As can be seen from the data in Tables 2 and 3, compared with the model group, the traditional Chinese medicine compositions prepared in each embodiment and comparative example of the present invention significantly increased the wound healing rate, greatly reduced the time required for complete healing, and significantly reduced the scar thickness after fumigation and washing of the wound.

[0118] The data in Table 2 show that the wound healing rate of rats showed an increasing trend over time. In the initial stage (3 days of administration), there was almost no significant difference in the wound healing rate between the examples and the comparative examples. However, as the administration time increased, the difference in wound healing rate between the examples and between the examples and the comparative examples increased. In particular, after 14 days of administration, the average wound healing rate of Examples 1 to 8 was greater than 99%, basically achieving complete healing. In contrast, the average wound healing rate of Comparative Examples 1 to 6 was less than 90%, indicating that the traditional Chinese medicine composition of the present invention has a significant effect on promoting wound healing.

[0119] Comparing Examples 1 to 3, Comparative Example 2, and Comparative Example 3, the addition of yam polysaccharide and / or snail polysaccharide to the traditional Chinese medicine composition significantly improved the wound healing rate over time.

[0120] Comparing Example 1 and Example 4, pretreatment of Gallnut and Red Vine before decoction significantly improved the wound healing rate.

[0121] Comparing Examples 1, 5 to 8, Comparative Examples 1, and 4 to 6, removing any component or adjusting the dosage in the temperature-release agent affected the wound healing rate. Especially in the early stages, the dosage of the adjusted component in the temperature-release agent caused significant fluctuations in wound healing effects, but in the later stages, the overall wound healing difference was not significant.

[0122] The data in Table 3 show that when the traditional Chinese medicine compositions prepared in Examples 1 to 8 of this invention are used to fumigate and wash the wounds, the average time required for complete wound healing is less than 15 days, and some wounds only require about 10 days, which shows a relatively fast healing speed. When the traditional Chinese medicine compositions prepared in Comparative Examples 1 to 6 are used to fumigate and wash the wounds, complete healing takes longer.

[0123] The main cause of scar formation after burns is the activation of an inflammatory response by patchy scars. The persistent inflammatory response leads to excessive proliferation of cells and the extracellular matrix, resulting in hypertrophic or contracture scars. When the traditional Chinese medicine compositions prepared in Examples 1 to 8 of this invention were used for fumigation and washing, the thickness of the regenerated scar significantly decreased after complete wound healing, indicating that the inflammatory response was effectively suppressed during wound repair. Simultaneously, the autophagy of fibroblasts was regulated, preventing their excessive proliferation. While the traditional Chinese medicine compositions prepared in Comparative Examples 1 to 6 improved the scar condition during fumigation and washing, their effects were not as good as those in the embodiments of this invention.

[0124] Comparing Examples 1 to 3, Comparative Example 2 and Comparative Example 3, the addition of yam polysaccharide and / or snail polysaccharide to the traditional Chinese medicine composition resulted in varying degrees of reduction in scar thickness.

[0125] Comparing Example 1 and Example 4, pretreatment of Gallnut and Red Vine before decoction resulted in a significant reduction in scar thickness.

[0126] Comparing Examples 1, 5 to 8, Comparative Examples 1, and 4 to 6, removing any component from the temperature-release agent or adjusting its dosage affected scar thickness. Specifically, removing any component resulted in a slight increase in scar thickness.

[0127] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A method for preparing a traditional Chinese medicine composition that promotes burn wound healing, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 15-20 parts of Cnidium monnieri; 20-40 parts of Sargentodoxa cuneata; 20-40 parts of Taraxacum mongolicum; 20-40 parts of Polygonum cuspidatum; 25-30 parts of Phellodendron chinense; 25-30 parts of Sophora flavescens; and 10-15 parts of Galla chinensis. Temperature-controlled release agent 1 to 5 parts; mucopolysaccharide 1 to 5 parts; The temperature-controlled release agents include menthol glycosides, tris(hydroxymethyl)aminomethane, and sodium alginate; The preparation method includes the following steps: Cnidium monnieri, red vine, dandelion, Polygonum cuspidatum, Phellodendron chinense, Sophora flavescens and Galla chinensis are mixed in proportion, boiled with water and decocted until the liquid is concentrated to 1 / 5 to 1 / 2 to obtain the original liquid, or freeze-dried to obtain freeze-dried powder. Then add a temperature-controlled release agent and mucopolysaccharide, and mix to obtain the traditional Chinese medicine composition; The mucopolysaccharide is at least one of yam polysaccharide and snail polysaccharide.

2. The method for preparing the traditional Chinese medicine composition for promoting burn wound healing according to claim 1, characterized in that, According to the mass ratio, in the temperature-release agent, menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = (5~10):(1~2):

1.

3. The method for preparing the traditional Chinese medicine composition for promoting burn wound healing according to claim 2, characterized in that, According to the mass ratio, in the temperature-release agent, menthol glycoside: tris(hydroxymethyl)aminomethane: sodium alginate = 5:1.5:

1.

4. The method for preparing the traditional Chinese medicine composition for promoting burn wound healing according to claim 1, characterized in that, The mucopolysaccharide is a mixture of yam polysaccharide and snail polysaccharide; According to the mass ratio, the ratio of yam polysaccharide to snail polysaccharide is 0.5~2:

1.

5. The method for preparing the traditional Chinese medicine composition for promoting burn wound healing according to claim 1, characterized in that, Before mixing, the gallnuts undergo pretreatment, specifically including: The gallnuts were soaked in an organic weak acid solution for 30 to 60 minutes; the organic weak acid solution was citric acid, acetic acid, or malic acid, with a mass concentration of 1% to 2%. After removing them from the oven, rinse them and bake them at a low temperature of 60℃~80℃ for 10 to 15 minutes, until the surface turns slightly yellow. It is crushed into 80-100 mesh particles.

6. The method for preparing the traditional Chinese medicine composition for promoting burn wound healing according to claim 1, characterized in that, Before mixing, the red vine undergoes pretreatment, specifically including: Cut the red vine into thin slices of 2mm to 5mm; Soak the slices of *Rhizoma Scutellariae* in a sodium bicarbonate solution with a mass concentration of 0.1% to 1% for 10 to 20 minutes; After removing, rinse and dry, then spray the surface of the red rattan slices evenly with a 50%~70% ethanol solution and let it moisten for 1~2 hours; Bake at a low temperature of 50-60℃ for 20-40 minutes.

7. The traditional Chinese medicine composition for promoting burn wound healing prepared by the method of any one of claims 1 to 6.

8. The application of the traditional Chinese medicine composition for promoting burn wound healing as described in claim 7, characterized in that, The application of the traditional Chinese medicine composition in the preparation of drugs that promote the healing of burn wounds.

9. The application of the traditional Chinese medicine composition for promoting burn wound healing according to claim 8, characterized in that, The method of using the medicine is fumigation and washing.

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