Traditional Chinese medicine composition for scalds and burns as well as preparation and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for scalds and burns as well as preparation and application thereof, and belongs to the technical field of traditional Chinese medicine treatment. The traditional Chinese medicine composition is prepared by combining raw materials including barks of barks of portulaca oleracea, barks of rubus corchorifolius, carbon crystals (coal crystals) and borneol according to a specific weight ratio, and raw tung oil is used as a matrix carrier. The preparation process is completed through the steps of raw material purification, drying, nanoscale crushing, precise proportioning, mixing and screening and the like, and the product is fine and uniform nanoscale powder. The traditional Chinese medicine composition is scientific and reasonable in formula, simple and controllable in preparation process and convenient and safe in medication mode, solves the problems of slow healing, obvious scars, easy infection, large side effects and the like of existing scald and burn treatment medicines, is suitable for various scenes such as family emergency, clinical medical treatment and outdoor operation, and has extremely high popularization and application values.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a scald and burn traditional Chinese medicine composition and preparation and application thereof. BACKGROUND

[0002] Scald and burn are common types of trauma in daily life, industrial production and accidents, and the essence is damage to the skin and subcutaneous tissue caused by high temperature. According to the depth of damage, scald and burn can be divided into degrees I, shallow II, deep II and III. Mild scald and burn mainly manifest as skin redness, swelling, pain and blister formation. Severe scald and burn can lead to skin ulceration, tissue necrosis, and even serious complications such as infection and shock, not only bringing great physiological pain and psychological trauma to patients, but also leaving permanent scars and seriously affecting the quality of life of patients.

[0003] At present, the drugs for treating scald and burn in clinical practice mainly include two categories of western medicine and traditional Chinese medicine. Western medicine drugs are mostly antibiotics and sulfonamide preparations (such as sulfadiazine silver cream and mupirocin ointment), which have the advantage of clear antibacterial and anti-inflammatory effect, but have obvious side effects, are prone to drug resistance, and have obvious scarring after healing. Some western medicines can also cause skin allergies and irritate the wound, and are particularly unsuitable for children, the elderly and patients with allergic constitution.

[0004] Traditional Chinese medicine has a long history and unique advantages in the treatment of scald and burn. Traditional Chinese medicine treatment is mainly based on clearing heat and resolving toxins, promoting blood circulation and removing blood stasis, and astringing and promoting tissue regeneration. Common traditional Chinese medicine raw materials include Coptis chinensis, Cortex Phellodendri, Rheum officinale, borneol and Arnebia euchroma. However, existing traditional Chinese medicine preparations have the following shortcomings: first, the formula design is unreasonable, and the synergistic effect of each component is not obvious, resulting in slow healing and limited treatment effect for deep II degree and above scald and burn; second, the preparation process is rough, and ordinary crushing is mostly used, so that the effective components of the raw materials are difficult to release fully, and the bioavailability is low; third, the drug administration method is complex, and frequent dressing and bandaging are required, which increases the risk of wound infection and is inconvenient to operate; fourth, some preparations have strong irritation and high scarring rate, and cannot meet the needs of clinical treatment.

[0005] In addition, there is a lack of scientific combination of mineral raw materials with plant raw materials and traditional Chinese medicine for opening the orifices in the prior art, especially the combination of Malin light tree bark, seven-star lotus, Guanshuayun hookstem and carbon crystal, borneol. Malin light tree bark is commonly used for external injury hemostasis in traditional folk medicine, seven-star lotus has the effects of clearing heat and resolving toxins, reducing swelling and relieving pain, Guanshuayun hookstem can promote blood circulation and remove blood stasis, promote tissue repair, carbon crystal has the effects of adsorbing and resisting bacteria and keeping the wound dry, and borneol can open the orifices and relieve pain, and promote drug penetration. Scientifically proportioning the above raw materials and using nanoscale crushing process can realize the synergistic effect of the effects of each component, and improve the bioavailability and treatment effect of the drug.

[0006] Therefore, developing a traditional Chinese medicine composition for burns and scalds that is scientifically formulated, easy to prepare, has definite curative effect, is safe with no side effects, and has a low scar formation rate is of great clinical significance and market value. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition for burns and scalds, its preparation and application, in order to solve the problems mentioned in the background art.

[0008] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition for burns and scalds comprises the following raw materials in parts by weight: 10 parts of *Rhizoma Scutellariae* bark, 10 parts of *Rhizoma Scutellariae*, 1.5 parts of *Rhizoma Scutellariae* stem, 1.5 parts of carbon crystal, and 0.5 parts of borneol; wherein the carbon crystal is a coal crystallization mineral purified from coal, with a purity ≥99.5%; and wherein each raw material is subjected to nano-level pulverization, with a powder particle size ≤100nm.

[0009] As a further aspect of the present invention: the bark of Viburnum macrocephalum is the dried bark of Viburnum macrocephalum, a plant of the Caprifoliaceae family. It is collected from October to December each year, and the outer bark and xylem impurities are removed, leaving only the phloem.

[0010] As a further aspect of the present invention: the seven-star lotus is the whole herb of the seven-star lotus plant of the Violaceae family and the Violaceae genus. The harvesting time is during the peak flowering period from June to August each year, and fresh plants that are free from diseases and pests and have strong growth are selected.

[0011] As a further aspect of the present invention: the rhizome of Rubus guanhua is the current year's lignified rhizome of Rubus guanhua, a plant of the genus Rubus in the family Rosaceae. The harvesting time is from September to October each year. Leaves, tender shoots and outer bark are removed, and the central xylem is retained.

[0012] A method for preparing a traditional Chinese medicine composition for burns and scalds includes the following steps: (1) Raw material pretreatment: The bark of the Malingguang tree, the stems of the Seven Star Lotus and the Guanhua Ruxie were cleaned to remove impurities, soil and non-medicinal parts. After washing, they were naturally sun-dried or dried at low temperature until the moisture content was ≤8% to make the raw materials brittle. (2) Nanoscale grinding: The pretreated raw materials are placed in a nano-grinding device and repeatedly hammered and crushed. The temperature is controlled at ≤40℃ during the grinding process to avoid loss of effective components. (3) Graded filtration: The crushed raw material powder is repeatedly filtered through multiple layers of filter screens. The first layer of filter screen has a pore size of 500 mesh, the second layer has a pore size of 1000 mesh, and the third layer has a pore size of 2000 mesh. Finally, nano-sized powder with a particle size ≤100nm is collected. (4) Precise proportioning: Weigh each raw material nano-powder according to the weight proportions described in claim 1 and place it in a sterile mixing device; (5) Mixing and sieving: The mixed powder after proportioning is stirred at a constant speed of 30-50 r / min for 30-60 minutes. After stirring, it is filtered again through a 2000 mesh filter to remove agglomerated particles and obtain the finished drug.

[0013] As a further aspect of the present invention: in step (1), the low-temperature drying temperature is 35-45℃, the drying time is 6-8 hours, and ventilation is maintained during the drying process to prevent the raw materials from becoming moldy.

[0014] As a further aspect of the present invention: in step (2), the nano-grinding equipment adopts a planetary ball mill, the grinding medium is zirconia balls, the ball-to-material ratio is 10:1, the grinding time is 2-4 hours, and the machine is stopped for 10 minutes every 30 minutes to cool down.

[0015] An application of a traditional Chinese medicine composition for burns and scalds, used in the treatment of first- to third-degree burns and scald wounds, with the specific method of administration as follows: (1) Wound treatment: First, clean the patient's wound, remove dirt and necrotic tissue, rinse with saline, disinfect with povidone-iodine, and let the wound air dry naturally; (2) Initial administration: Apply a layer of raw tung oil evenly to the dried wound surface. The thickness of the raw tung oil application should be 0.1-0.2 mm. Then apply the finished medicine evenly to the wound surface. The thickness of the application should be 0.3-0.5 mm. No bandaging is required. (3) Follow-up care: If the medicine does not fall off, apply raw tung oil evenly when the surface of the medicine is cracked to keep the medicine moist; if the medicine falls off due to external force, apply raw tung oil again and then apply the finished medicine until the wound heals on its own and the medicine falls off naturally.

[0016] As a further aspect of the present invention: the raw tung oil is fresh raw tung oil that is free from spoilage and odor, with an acid value ≤4mgKOH / g and a saponification value of 190-200mgKOH / g.

[0017] Compared with the prior art, the beneficial effects of the present invention are: 1. Scientific formulation and synergistic effect: This invention organically combines plant-based Chinese medicines (bark of *Lysimachia christinae*, *Symplocos buergeriana*, and stems of *Rubus idaeus*) with mineral raw materials (carbon crystals) and orifice-opening Chinese medicines (borneol). Each component is formulated in a specific ratio to achieve synergistic effects of clearing heat and detoxifying, reducing swelling and relieving pain, antibacterial and anti-inflammatory, promoting blood circulation and removing blood stasis, and promoting wound healing and tissue regeneration. The therapeutic effect is significantly better than that of single-component or traditional formulas.

[0018] 2. Rapid healing: The nano-level pulverization process ensures full release of the active ingredients, and borneol promotes transdermal absorption, significantly improving bioavailability. Experimental data shows that the healing time for first- to third-degree burns treated with the composition of this invention is shortened by 29.3%-40.0% compared to traditional Western medicine, with a clinical cure rate of 75.0%.

[0019] 3. Good antibacterial and anti-infection effects: Each component has a certain antibacterial effect, and under synergistic effect, it can effectively inhibit common pathogenic bacteria such as Staphylococcus aureus and Escherichia coli. The wound infection rate is less than 10%, which is significantly better than existing drugs.

[0020] 4. Significant analgesic effect: Borneol has a rapid analgesic effect, and combined with the anti-inflammatory effects of other components, it can effectively relieve severe pain after burns. The pain score can drop to below 3.2 points within 1 day after treatment, greatly improving patient comfort.

[0021] 5. Low scar formation rate: By promoting orderly repair of wound tissue and reducing abnormal collagen proliferation, the scar-free rate reaches 70.0%, the scar formation rate is only 30.0%, and there is no severe scar formation, thus improving the healing quality of patients.

[0022] 6. Convenient medication application, no bandaging required: The medication is applied using a "tung oil base + powder top dressing" method, which is simple to operate, requires no bandaging, keeps the wound breathable, reduces the number of dressing changes and the difficulty of operation, and is suitable for use in various scenarios such as home emergency and outdoor work.

[0023] 7. High safety and no side effects: All raw materials are natural Chinese medicines or minerals, which are scientifically purified and processed. In clinical trials, only one case of mild itching occurred, and there were no other serious adverse reactions. It is suitable for children, the elderly and patients with allergies. Detailed Implementation

[0024] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0025] The raw material composition and weight parts of a traditional Chinese medicine composition for burns and scalds are as follows: Bark of the Malingguang tree: 10 portions Seven-Star Lotus: 10 servings Raspberry stem: 1.5 parts Carbon crystal: 1.5 parts Borneol: 0.5 parts.

[0026] Selection criteria and pharmacological effects of each raw material 1. Bark of the Malingguang tree Viburnum macrocephalum is a plant belonging to the genus Viburnum in the family Caprifoliaceae. It is mainly distributed in southwestern and southern my country, and its bark is a traditional folk medicinal part. This invention selects Viburnum macrocephalum bark collected from October to December each year, when the content of effective ingredients in the bark is the highest. The outer bark and xylem impurities are removed, and only the phloem is retained.

[0027] Modern pharmacological studies have shown that the bark of the *Hylocereus undatus* tree contains flavonoids, phenolic acids, terpenes, and other active ingredients, which have the following pharmacological effects: Anti-inflammatory effects: Flavonoids can inhibit the release of inflammatory mediators such as histamine and prostaglandins, and reduce redness, swelling and pain in wounds; Hemostatic effect: Phenolic acid components can promote platelet aggregation, shorten clotting time, quickly stop bleeding, and reduce wound bleeding; Antibacterial effect: It has an inhibitory effect on common pathogens causing wound infections such as Staphylococcus aureus and Escherichia coli, reducing the risk of infection.

[0028] 2. Seven-star lotus Viola yedoensis is an annual herbaceous plant belonging to the genus Viola in the family Violaceae. It is widely distributed throughout my country, and the whole plant can be used medicinally. This invention selects fresh Viola yedoensis during its peak flowering period from June to August each year, when the plant is vigorous, has accumulated sufficient active ingredients, and is free from pests and diseases.

[0029] Seven-star lotus contains active ingredients such as violetin, flavonoid glycosides, and organic acids, and its pharmacological effects are as follows: Clearing heat and detoxifying: It can remove local heat toxins from the wound and relieve the burning pain after burns; Reduce swelling and relieve pain: By inhibiting the inflammatory response, it reduces swelling of the wound and relieves pain symptoms; Promotes healing: It can promote fibroblast proliferation and collagen synthesis, accelerate the growth of granulation tissue in the wound, and shorten the healing time.

[0030] 3. Close the stalk of the raspberry branch. Rubus guanhuaensis is a plant belonging to the genus Rubus in the family Rosaceae. It is mainly distributed in Yunnan, Sichuan, and Tibet in my country, and its stems have high medicinal value. This invention selects the current year's lignified stems collected in September and October each year, removes the leaves, tender shoots, and outer bark, and retains the central xylem.

[0031] The stems of Rubus guanyla contain tannins, polysaccharides, alkaloids, and other active ingredients, which have the following effects: Promotes blood circulation and removes blood stasis: Improves local blood circulation in the wound, promotes the dissipation of blood stasis, and provides sufficient nutrient supply for tissue repair; Astringent and tissue-regenerating: Tannins can astringe the wound, reduce exudation, protect the wound from external stimuli, and promote the regeneration of epithelial cells. Boosting immunity: Polysaccharide components can regulate the body's immune function and improve the local anti-infection ability of the wound.

[0032] 4. Carbon crystals (coal crystals) Carbon crystals are high-purity coal crystal minerals purified from coal. This invention selects carbon crystals with a purity of ≥99.5%, whose main component is elemental carbon, and which have a porous structure and a large specific surface area.

[0033] The pharmacological effects and functions of carbon crystals are as follows: Adsorption: The porous structure can adsorb secretions, pus and bacteria from the wound, keeping the wound dry and clean and reducing the chance of infection; Antibacterial effect: It inhibits bacterial growth and reproduction by physically adsorbing and destroying the bacterial cell membrane structure. It has a good inhibitory effect on both Gram-positive and Gram-negative bacteria. Thermal insulation and protection: When carbon crystal powder is applied to the wound, it can form a protective film, which can insulate against heat, prevent external friction and irritation, and reduce the patient's pain.

[0034] 5. Borneol Borneol is a resin product of the Dipterocarpus borneol plant (Dipterocarpus borneolaceae) or synthetic borneol. This invention uses natural borneol with a purity of ≥98%.

[0035] The pharmacological effects of borneol are as follows: It has a significant analgesic effect, which can quickly relieve severe pain after burns and scalds, and improve patient comfort. Promotes penetration: It can change the structure of the stratum corneum of the skin, increase the transdermal absorption efficiency of other drug components, and improve bioavailability; Antibacterial and anti-inflammatory: It has an inhibitory effect on a variety of pathogenic bacteria and works synergistically with other ingredients to enhance the anti-infection effect.

[0036] Synergistic effect principle of formulation ratio The formula of this invention is not a simple sum of ingredients, but rather based on the treatment principles of traditional Chinese medicine, namely "clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and promoting tissue regeneration and wound healing," combined with modern pharmacological research, to achieve synergistic effects among the components: The bark of the Malingguang tree and the seven-star lotus are used as the main ingredients, with the largest dosage (10 parts each). The two work together to clear heat and detoxify, reduce inflammation and relieve pain, and fight bacteria and stop bleeding, quickly controlling the inflammatory response of the wound and laying the foundation for tissue repair. The stem of Rubus guanhua (1.5 parts) is used as an adjuvant to promote blood circulation, remove blood stasis, promote wound healing, and accelerate healing. Carbon crystals (1.5 parts) are used as an adjuvant to adsorb and fight bacteria, protect the wound, solve the problems of excessive wound secretions and easy infection, and create a good environment for healing. Borneol (0.5 parts) is used as an adjuvant to open the orifices, relieve pain, and promote penetration. It can not only quickly relieve pain, but also promote the absorption of other effective ingredients and improve the overall efficacy.

[0037] The weight proportions of each component were determined through extensive experimental optimization. Insufficient dosage of *Rhizoma Scutellariae* bark or *Rhizoma Scutellariae* will weaken the anti-inflammatory and antibacterial effects; excessive dosage of *Rhizoma Scutellariae* stem may worsen wound bruising; excessive carbon crystal dosage will affect drug permeability; and excessive borneol dosage may irritate the wound. The formulation of this invention allows the components to complement each other's effects, achieving the best therapeutic effect.

[0038] Preparation method The preparation method of the traditional Chinese medicine composition of the present invention includes the following specific steps: 1. Raw material pretreatment Ma Lingguang bark: After collection, immediately remove the outer bark, wood and impurities, rinse with clean water 3-5 times to remove surface dust and dirt, then place in a ventilated and dry place to dry naturally, or put in a low temperature drying oven at 35-45℃ to dry for 6-8 hours, keeping the ventilation during the process to avoid mold, until the moisture content is ≤8%, so that the bark becomes brittle and easy to crush later. Seven Star Lotus: Collect fresh whole plant, remove weeds, dead leaves and soil, rinse with clean water, drain the water, place in a ventilated and dry place to dry naturally, or dry at low temperature until the moisture content is ≤8% to ensure the plant becomes brittle. Raspberry stems: After harvesting, cut into 5-10cm sections, remove leaves, tender shoots and outer skin, rinse with clean water, sun dry or low temperature dry until the moisture content is ≤8% and the texture becomes brittle; Carbon crystals: Select coal crystals with a purity of ≥99.5% from coal, remove impurities and gangue, and crush them into small pieces for later use; Borneol: Select natural borneol crystals, remove impurities, and keep them dry for later use.

[0039] 2. Nanoscale pulverization The pretreated bark of *Malus baccata*, *Symplocos buergeriana*, *Rubus idaeus* stems, carbon crystals, and borneol were placed in a planetary ball mill. Zirconia balls were used as the grinding medium, with a ball-to-material ratio of 10:1. The grinding time was 2-4 hours, with the mill stopped for 10 minutes every 30 minutes to cool down. The grinding temperature was controlled to be ≤40℃ to prevent the loss or deterioration of active ingredients due to high temperature.

[0040] 3. Staged filtration The pulverized raw material powders are then filtered separately through multiple layers of filter screens. First layer: 500-mesh filter to remove large particles of impurities; Second layer: 1000-mesh filter screen, for filtering medium-sized particles; The third layer: a 2000-mesh filter to collect nano-sized powders with a particle size ≤100nm.

[0041] After each filtration layer, the filter screen is cleaned to ensure filtration effect. The filtration is repeated 3-5 times until the powder particle size reaches the nanoscale standard. Then, the nanoscale powder of each raw material is placed in a sterile container and sealed for later use.

[0042] 4. Precise proportions According to the weight ratio (10 parts of bark of *Malus baccata*, 10 parts of *Symplocos buergeriana*, 1.5 parts of stem of *Rubus idaeus*, 1.5 parts of carbon crystal, and 0.5 parts of borneol), the nano-sized powders of each raw material were accurately weighed using an electronic balance (accuracy 0.001g) and placed into a sterile mixing device.

[0043] 5. Mixing and screening The mixed powders are stirred at a constant speed of 30-50 rpm for 30-60 minutes to ensure uniform mixing of all components. After stirring, the mixed powders are filtered again through a 2000-mesh filter to remove any agglomerated particles, resulting in a uniform and fine finished product. This product is then sealed in a package and stored in a cool, dry place.

[0044] Application methods The traditional Chinese medicine composition of this invention is mainly used for the treatment of first- to third-degree burns and scalds. It is convenient to administer and requires no bandaging. Specific application methods are as follows: 1. Wound treatment First, thoroughly clean the patient's wound. Gently wipe away dirt, necrotic tissue, and pus with sterile gauze. Then, rinse the wound with saline solution 3-5 times. Next, disinfect the wound and surrounding skin with povidone-iodine, extending the disinfection area 2-3 cm beyond the wound edge. Allow the wound to air dry naturally (avoid wiping with gauze to prevent damage to newly formed tissue).

[0045] 2. Initial administration After the wound has dried, apply a layer of fresh tung oil evenly with a sterile cotton swab. The acid value of the tung oil should be ≤4 mgKOH / g, and the saponification value should be 190-200 mgKOH / g. The application thickness should be 0.1-0.2 mm to ensure complete coverage of the wound. Then, take the finished medicine of this invention and apply it evenly to the wound with a sterile spoon to a thickness of 0.3-0.5 mm, ensuring full contact between the medicine and the wound. No bandaging is required; keep the wound breathable.

[0046] 3. Follow-up care If the medication does not fall off due to external force, friction, or other factors, there is no need to reapply it; simply observe the wound daily. If cracks appear on the surface of the medication, use a sterile cotton swab to apply raw tung oil evenly to the surface, keeping the medication moist until the wound heals on its own and the medication falls off naturally. If the medication is partially or completely detached due to external force, the wound needs to be cleaned again (rinsed with saline solution and dried), raw tung oil is applied, and the finished medication is applied again. For first-degree burns, there is generally no need to change the medication, and they will heal in 1-3 days; superficial second-degree burns heal in 7-10 days; deep second-degree burns heal in 15-20 days; and third-degree burns require 25-30 days to heal. During this period, the nursing care method should be adjusted according to the wound healing process. For critically ill patients with burns covering more than 30% of their body surface area, the composition of this invention should be used in conjunction with conventional treatments such as intravenous fluid replacement, anti-infection, and analgesia to ensure the stability of the patient's vital signs.

[0047] Experimental data and effect verification To verify the therapeutic effects of the traditional Chinese medicine composition of this invention, the applicant conducted a series of animal experiments and clinical trials, as detailed below: 1. Animal experiments (1) Experimental materials Laboratory animals: 60 SPF-grade SD rats, half male and half female, weighing 200-250g, provided by a certain laboratory animal center; Experimental drugs: the traditional Chinese medicine composition prepared in Example 1 of this invention (hereinafter referred to as "experimental group drug"), commercially available silver sulfadiazine cream (hereinafter referred to as "control group drug"), physiological saline, iodine tincture, and raw tung oil; Experimental equipment: electronic balance, constant temperature incubator, surgical instruments, wound measuring instrument, microscope, etc.

[0048] (2) Experimental methods Establishment of the burn model: After 3 days of adaptive feeding, rats were anesthetized by intraperitoneal injection of sodium pentobarbital (30 mg / kg). After hair removal on the back, a 2 cm diameter round copper rod was heated in an 80℃ constant temperature water bath for 5 minutes. Then, it was pressed on the hair removal area on the rat's back with a pressure of 0.5 kg / cm². The pressing time was 10 seconds for superficial second-degree burns and 20 seconds for deep second-degree burns to establish the burn model. Grouping: Sixty rats were randomly divided into 6 groups of 10 each: superficial second-degree burn experimental group, superficial second-degree burn control group, deep second-degree burn experimental group, deep second-degree burn control group, blank control group (treated with physiological saline only), and tung oil control group (treated with raw tung oil only). Administration method: The experimental group was administered the drug according to the application method of the present invention, the control group was given silver sulfadiazine cream once a day, the blank control group was rinsed with physiological saline, and the tung oil control group was given only raw tung oil. All groups were fed routinely and the wound healing was observed.

[0049] (3) Experimental indicators and results Healing time: The time for complete wound healing (100% epithelialization) in each group of rats was recorded. The results are shown in Table 1 below: Table 1 Wound healing time in rats of each group (x±s, days) Group Superficial Ⅱ degree burn Deep Ⅱ degree burn Experimental group 7.2±1.1 16.5±2.3 Control group 11.5±1.5 24.8±2.8 Blank control group 18.3±2.1 35.6±3.2 Tung oil control group 15.7±1.8 30.2±2.9 As shown in Table 1, the wound healing time in the experimental group was significantly shorter than that in the control group, the blank control group, and the tung oil control group (P < 0.05). The healing time for superficial second-degree burns was shortened by 37.4%, and the healing time for deep second-degree burns was shortened by 33.5%, indicating that the composition of the present invention can significantly accelerate wound healing.

[0050] Wound infection rate: The infection rate was calculated by observing whether the wounds of rats in each group showed symptoms of infection such as redness, swelling, suppuration, and increased secretions. The results are shown in Table 2 below. Table 2. Wound infection rate (%) in rats of each group Group Superficial Ⅱ degree burn Deep Ⅱ degree burn Experimental group 0 10% Control group 10% 20% Blank control group 60% 80% Tung oil control group 40% 60% As shown in Table 2, the wound infection rate in the experimental group was significantly lower than that in the other groups. No infection occurred in superficial second-degree burns, and the infection rate in deep second-degree burns was only 10%, indicating that the composition of the present invention has good antibacterial and anti-infective effects.

[0051] Histopathological observation: At 3, 7, and 14 days post-scald, two rats were randomly selected from each group, sacrificed, and the tissue away from the wound was stained with hematoxylin and eosin (HE) for microscopic observation of tissue repair. Results showed: Experimental group: 3 days after the burn, there was less infiltration of inflammatory cells in the wound and fibroblasts began to proliferate; 7 days later, granulation tissue grew vigorously and epithelial cells began to migrate and cover the wound; 14 days later, the wound was basically healed and collagen was neatly arranged. Control group: 3 days after the burn, there was obvious infiltration of inflammatory cells; 7 days after the burn, the growth of granulation tissue was slow; 14 days after the burn, there was still part of the wound that had not healed and the collagen arrangement was disordered. The blank control group and the tung oil control group showed that the tissue repair process was significantly delayed, the inflammatory response lasted for a long time, and the granulation tissue growth was sparse.

[0052] 2. Clinical trials (1) Experimental subjects This study selected 120 burn patients admitted to a hospital between January 2022 and January 2023, including 68 males and 52 females, aged 3-65 years, with a mean age of 32.5 years. Burn types included: first-degree burns (20 cases), superficial second-degree burns (50 cases), deep second-degree burns (40 cases), and third-degree burns (10 cases); burn area ranged from 5% to 30%, with an average burn area of ​​12.5%.

[0053] 120 patients were randomly divided into an experimental group and a control group, with 60 patients in each group. There were no significant differences in general information such as gender, age, degree of burn, and burn area between the two groups (P>0.05), and they were comparable.

[0054] (2) Treatment methods Experimental group: treated with the traditional Chinese medicine composition and application method of the present invention; Control group: The conventional treatment method was used, namely, after cleaning and disinfecting the wound, applying silver sulfadiazine cream, bandaging with sterile gauze, and changing the dressing once a day.

[0055] (3) Efficacy evaluation criteria Healed: The wound has completely healed with a 100% epithelialization rate and no symptoms of redness, swelling, pain, or infection. Significant effect: wound healing rate ≥80%, redness, swelling and pain significantly reduced, no infection; Effective: Wound healing rate ≥50%, redness, swelling and pain are reduced, and there is no obvious infection; Ineffective: Wound healing rate <50%, no improvement in redness, swelling, and pain, or infection or worsening of symptoms.

[0056] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0057] (4) Experimental results Clinical efficacy: The efficacy of the two groups of patients 28 days after treatment is shown in Table 3 below: Table 3 Comparison of clinical efficacy between the two groups of patients (cases, %) Group Number of cases Cure Marked effect Effectiveness Ineffectiveness Total effective rate Experimental group 60 45（75.0） 10（16.7） 3（5.0） 2（3.3） 96.7 Control group 60 28（46.7） 15（25.0） 8（13.3） 9（15.0） 85.0 As shown in Table 3, the cure rate and total effective rate of the experimental group were significantly higher than those of the control group (P<0.05), with a total effective rate of 96.7%, indicating that the clinical therapeutic effect of the composition of the present invention is better than that of conventional Western medicine.

[0058] Healing time: The healing time for different degrees of burns in the two groups of patients is shown in Table 4 below: Table 4 Wound healing time (x±s, days) for the two groups of patients Burn degree Experimental group Control group Shortening ratio Ⅰ degree 2.1±0.5 3.5±0.8 40.0% Superficial Ⅱ degree 8.5±1.2 13.2±1.5 35.6% Deep Ⅱ degree 17.8±2.5 26.5±2.8 32.8% Ⅲ degree 27.3±3.1 38.6±3.5 29.3% As shown in Table 4, the healing time of burns of all degrees in the experimental group was significantly shorter than that in the control group, with a reduction rate between 29.3% and 40.0%, indicating that the composition of the present invention can effectively shorten the wound healing time.

[0059] Pain rating: The visual analog scale (VAS) was used to assess the pain level of patients before treatment and at 1, 3, and 7 days after treatment. The maximum score is 10 points, with higher scores indicating more severe pain. The results are shown in Table 5 below: Table 5. VAS pain scores (x±s, points) for the two groups of patients. Time point Experimental group Control group Before treatment 7.8±1.2 7.6±1.3 1 day after treatment 3.2±0.8 5.5±1.1 3 days after treatment 1.5±0.5 3.8±0.9 7 days after treatment 0.3±0.2 1.6±0.6 As shown in Table 5, at each time point after treatment, the pain scores of the experimental group were significantly lower than those of the control group (P<0.05), indicating that the analgesic effect of the composition of the present invention is superior.

[0060] Scar formation: Three months after treatment, the scar formation on the patient's wound was observed. The scar height, color, and flexibility were assessed using the Scar Rating Scale (VSS). The results are shown in Table 6 below: Table 6 Comparison of scar formation between the two groups of patients (cases, %) Group Number of cases No scar Mild scar (VSS≤3 points) Moderate scar (3 Severe scar (VSS>6 points) Scar formation rate Experimental group 60 42（70.0） 15（25.0） 3（5.0） 0（0） 30.0 Control group 60 20（33.3） 22（36.7） 15（25.0） 3（5.0） 66.7 As shown in Table 6, the scar-free rate of the experimental group reached 70.0%, the scar formation rate was only 30.0%, and there was no severe scar formation; the scar-free rate of the control group was only 33.3%, and the scar formation rate was 66.7%, indicating that the composition of the present invention can significantly reduce the scar formation rate and improve the healing quality.

[0061] Safety evaluation: During treatment, both groups of patients were observed for adverse reactions such as allergies and irritation. In the experimental group, only one patient experienced mild skin itching, which subsided spontaneously without discontinuation of the medication. In the control group, eight patients experienced allergic reactions such as skin redness and itching, requiring discontinuation of the medication. This indicates that the composition of the present invention has higher safety and fewer side effects. Example

[0062] A traditional Chinese medicine composition for burns and scalds, comprising the following raw materials and parts by weight: 10g of bark of *Lysimachia christinae*, 10g of *Symplocos buergeriana*, 1.5g of stem of *Rubus idaeus*, 1.5g of carbon crystals, and 0.5g of borneol.

[0063] Preparation method: 1. Raw material pretreatment: Remove the outer bark and wood of the bark of the *Mallotus arvense* tree, wash it, and dry it at 35℃ for 6 hours with a moisture content of 7%; remove weeds and soil from the *Symplocos rubra* tree, wash it, and sun-dry it with a moisture content of 6%; cut the stems of *Rubus idaeus* into 5cm sections, remove the outer bark, wash it, and dry it at 40℃ for 7 hours with a moisture content of 8%; remove impurities from the carbon crystals and crush them into small pieces; remove impurities from the borneol and set aside.

[0064] 2. Nanoscale grinding: Place each raw material in a planetary ball mill with a ball-to-material ratio of 10:1, grind for 2 hours, and control the temperature at 35℃.

[0065] 3. Graded filtration: Powder with a particle size ≤100nm is collected by repeatedly filtering through 500-mesh, 1000-mesh, and 2000-mesh filters.

[0066] 4. Precise proportioning: Weigh each powder according to the above weight proportions and put them into a sterile mixing device.

[0067] 5. Mixing and sieving: Stir at 30 r / min for 30 minutes, filter through a 2000 mesh screen to obtain the finished drug.

[0068] Application method: 1. Wound treatment: Rinse the wound with saline solution, disinfect with povidone-iodine, and allow it to air dry.

[0069] 2. Initial administration: Apply a 0.1mm thick layer of raw tung oil, followed by a 0.3mm thick layer of the finished medication. No bandaging is required.

[0070] 3. Follow-up care: When the medicine dries and cracks, apply raw tung oil; when it falls off, reapply the medicine until it heals. Example

[0071] A traditional Chinese medicine composition for burns and scalds, comprising the following raw materials and their weight parts: 20g of bark of *Lysimachia christinae*, 20g of *Symplocos buergeriana*, 3g of stem of *Rubus idaeus*, 3g of carbon crystals, and 1g of borneol.

[0072] Preparation method: 1. Raw material pretreatment: The bark of the *Rhizophora stylosa* tree was washed and dried at 40℃ for 7 hours to a moisture content of 6%; the *Symplocos buergeriana* was dried at low temperature to a moisture content of 7%; the stems of *Rubus idaeus* were cut into 8cm sections and dried at 45℃ for 6 hours to a moisture content of 7%; carbon crystals and borneol were purified and prepared for use.

[0073] 2. Nanoscale grinding: Grinding in a planetary ball mill for 3 hours, ball-to-material ratio 10:1, temperature 38℃.

[0074] 3. Graded filtration: The powder with a particle size ≤80nm is collected by repeatedly filtering through multiple layers of filter screens 5 times.

[0075] 4. Precise proportioning: Weigh each powder according to the weight parts and put it into the mixing equipment.

[0076] 5. Mixing and sieving: Stir at 40 r / min for 45 minutes, filter through a 2000 mesh screen to obtain the finished product.

[0077] The application method is the same as in Example 1, and it is suitable for patients with large burn areas. Example

[0078] A traditional Chinese medicine composition for burns and scalds, comprising the following raw materials and their weight parts: 5g of bark of *Lysimachia christinae*, 5g of *Symplocos buergeriana*, 0.75g of stem of *Rubus idaeus*, 0.75g of carbon crystals, and 0.25g of borneol.

[0079] Preparation method: 1. Raw material pretreatment: Sun-dry the bark of *Mallotus philippinensis* to a moisture content of 8%; Sun-dry the *Symplocos rubra* to a moisture content of 6%; Cut the stems of *Rubus idaeus* into 10cm sections and sun-dry them to a moisture content of 7%; Purify carbon crystals and borneol for later use.

[0080] 2. Nanoscale grinding: Grinding in a planetary ball mill for 4 hours, ball-to-material ratio 10:1, temperature 32℃.

[0081] 3. Graded filtration: The powder with a particle size ≤90nm is collected by repeatedly filtering through multiple layers of filter screens 4 times.

[0082] 4. Precise proportioning: Weigh each powder according to the weight parts and put it into the mixing equipment.

[0083] Mixing and sieving: Stir at 50 rpm for 60 minutes, filter through a 2000-mesh filter to obtain the finished product.

[0084] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. A traditional Chinese medicine composition for burns and scalds, characterized in that, It is composed of the following raw materials in parts by weight: 10 parts of bark of *Rhizoma Spathiphyllum*, 10 parts of *Rhizoma Spathiphyllum*, 1.5 parts of stem of *Rhizoma Spathiphyllum*, 1.5 parts of carbon crystal, and 0.5 parts of borneol; the carbon crystal is a coal crystallization mineral purified from coal with a purity ≥99.5%; all raw materials are subjected to nano-level pulverization, and the powder particle size is ≤100nm.

2. The traditional Chinese medicine composition for burns and scalds according to claim 1, characterized in that, The bark of Viburnum macrocephalum is the dried bark of Viburnum macrocephalum, a plant belonging to the genus Viburnum in the family Caprifoliaceae. It is collected from October to December each year, and the outer bark and xylem impurities are removed, leaving only the phloem.

3. The traditional Chinese medicine composition for burns and scalds according to claim 1, characterized in that, The Seven Star Lotus refers to the whole plant of Viola spp., a plant belonging to the Violaceae family. The harvesting time is from June to August each year during the peak flowering period, selecting fresh plants that are free from pests and diseases and have vigorous growth.

4. The traditional Chinese medicine composition for burns and scalds according to claim 1, characterized in that, The *Rubus guanhuai* stems are the current year's woody stems of *Rubus guanhuai*, a plant belonging to the genus *Rubus* in the family Rosaceae. They are collected annually from September to October, with leaves, tender shoots, and outer bark removed, while retaining the central xylem.

5. A method for preparing a traditional Chinese medicine composition for burns and scalds as described in any one of claims 1-4, characterized in that, Includes the following steps: (1) Raw material pretreatment: The bark of the Malingguang tree, the stems of the Seven Star Lotus and the Guanhua Ruxie were cleaned to remove impurities, soil and non-medicinal parts. After washing, they were naturally sun-dried or dried at low temperature until the moisture content was ≤8% to make the raw materials brittle. (2) Nanoscale grinding: The pretreated raw materials are placed in a nano-grinding device and repeatedly hammered and crushed. The temperature is controlled at ≤40℃ during the grinding process to avoid loss of effective components. (3) Graded filtration: The crushed raw material powder is repeatedly filtered through multiple layers of filter screens. The first layer of filter screen has a pore size of 500 mesh, the second layer has a pore size of 1000 mesh, and the third layer has a pore size of 2000 mesh. Finally, nano-sized powder with a particle size ≤100nm is collected. (4) Precise proportioning: Weigh each raw material nano-powder according to the weight proportions described in claim 1 and place it in a sterile mixing device; (5) Mixing and sieving: The mixed powder after proportioning is stirred at a constant speed of 30-50 r / min for 30-60 minutes. After stirring, it is filtered again through a 2000 mesh filter to remove agglomerated particles and obtain the finished drug.

6. The preparation method according to claim 5, characterized in that, In step (1), the low-temperature drying temperature is 35-45℃ and the drying time is 6-8 hours. During the drying process, ventilation should be maintained to prevent the raw materials from becoming moldy.

7. The preparation method according to claim 5, characterized in that, In step (2), the nano-grinding equipment uses a planetary ball mill, the grinding media is zirconia balls, the ball-to-material ratio is 10:1, the grinding time is 2-4 hours, and the machine is stopped for 10 minutes every 30 minutes to cool down.

8. The application of the traditional Chinese medicine composition for burns and scalds according to claim 1, characterized in that, It is used to treat first- to third-degree burns and scalds. The specific method of administration is as follows: (1) Wound treatment: First, clean the patient's wound, remove dirt and necrotic tissue, rinse with saline, disinfect with povidone-iodine, and let the wound air dry naturally; (2) Initial administration: Apply a layer of raw tung oil evenly to the dried wound surface. The thickness of the raw tung oil application should be 0.1-0.2 mm. Then apply the finished medicine evenly to the wound surface. The thickness of the application should be 0.3-0.5 mm. No bandaging is required. (3) Follow-up care: If the medicine does not fall off, apply raw tung oil evenly when the surface of the medicine is cracked to keep the medicine moist; if the medicine falls off due to external force, apply raw tung oil again and then apply the finished medicine until the wound heals on its own and the medicine falls off naturally.

9. The application according to claim 8, characterized in that, The raw tung oil is fresh tung oil that has not deteriorated or has no off-odor, with an acid value ≤4mgKOH / g and a saponification value of 190-200mgKOH / g.