Traditional Chinese medicine composition for treating scalds

Abstract

The invention discloses a traditional Chinese medicine composition for treating scalds. The traditional Chinese medicine composition is prepared from the following medicines in parts by weight: 10-20 parts of willow, 10-20 parts of jujube root, 10-15 parts of sophora japonica, 10-15 parts of elm, 10-25 parts of borneol, 500-800 parts of sesame oil and 180-220 parts of yellow wax. The invention also discloses a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition disclosed by the invention has multiple effects of resisting bacteria, diminishing inflammation, relieving pain, promoting healing, reducing scar formation and the like through a multi-component and multi-target synergistic effect. The traditional Chinese medicine composition can effectively relieve inflammatory response of scalded wounds, promote newborn epithelium coverage, shorten healing time and reduce the risk of scar formation, and is more comprehensive and more remarkable in curative effect. The traditional Chinese medicinal materials used in the invention are all from natural plants, and most impurities and toxic components are removed through strict processing and extraction process treatment. The traditional Chinese medicine composition has no obvious irritation to skin and is high in safety.

Description

Technical Field

[0001] The present invention relates to the technical field of medical drugs, and specifically refers to a traditional Chinese medicine composition for treating scalds. Background Art

[0002] Scald is a common accidental injury. Mild scald usually only causes damage to the skin surface layer, while severe scald may damage the entire skin layer and even reach deep tissues such as muscles and bones, leading to serious infections, scar formation, and functional disorders. Currently, the clinical treatment methods for scalds mainly include:

[0003] Local treatment: Using antibacterial drugs (such as silver sulfadiazine cream) to prevent and control infections and promote wound healing.

[0004] Systemic treatment: For patients with severe scalds, comprehensive treatments such as fluid resuscitation, nutritional support, and prevention of complications are required.

[0005] However, there are still some limitations in the existing treatment methods:

[0006] Antibacterial drug resistance: With the widespread use of antibacterial drugs, the problem of bacterial drug resistance has become increasingly prominent, resulting in poor responses of some patients to traditional antibacterial drugs.

[0007] Slow healing speed: The traditional treatment methods have limited effects on promoting wound healing, resulting in longer recovery times for patients and affecting their quality of life.

[0008] High risk of scar formation: During the repair process of skin tissues after scald, hypertrophic scars are likely to form, affecting appearance and function.

[0009] Obvious side effects: Some chemical drugs have certain side effects, such as local irritation, allergic reactions, etc.

[0010] Traditional Chinese medicine has a long history and rich experience in treating scalds. Its characteristics of multi-components and multi-targets make it show unique advantages in scald treatment:

[0011] Antibacterial and anti-inflammatory: Many traditional Chinese medicines have broad-spectrum antibacterial effects, can effectively inhibit the growth and reproduction of various pathogenic microorganisms, and at the same time their anti-inflammatory effects can reduce local inflammatory reactions.

[0012] Promote healing: The components of traditional Chinese medicine can promote the proliferation of fibroblasts and collagen synthesis, and accelerate the wound healing process.

[0013] Reduce scar formation: Some traditional Chinese medicines have the effect of regulating extracellular matrix metabolism and can reduce the formation of scar tissues.

[0014] High safety: Traditional Chinese medicine is derived from natural plants, has relatively few side effects, and has high safety.

[0015] At present, some traditional Chinese medicine preparations have been applied to the treatment of burns. For example:

[0016] Moist Burn Ointment: The main ingredients are Scutellaria baicalensis, Phellodendron amurense, Coptis chinensis, etc., which have the effects of clearing heat and detoxifying, promoting blood circulation to remove stasis, relieving pain and promoting granulation.

[0017] Jingwanhong Ointment: It is composed of traditional Chinese medicines such as Sanguisorba officinalis, Rheum palmatum, Coptis chinensis, etc., and has the functions of detumescence and pain relief, promoting blood circulation to remove stasis, and removing necrotic tissue to promote granulation.

[0018] However, there are still some deficiencies in the existing traditional Chinese medicine burn preparations:

[0019] Complex components and unclear action mechanism: Some traditional Chinese medicine preparations have complex components, making it difficult to clarify their specific action mechanisms, which affects their clinical application and promotion.

[0020] Unstable curative effect: Due to the influence of factors such as the quality of Chinese herbal medicines and the preparation process, the curative effect of the products fluctuates to a certain extent.

[0021] Single dosage form: Most of the existing traditional Chinese medicine burn preparations are in the form of ointment, which has problems such as inconvenient use and difficult to carry.

[0022] Therefore, a traditional Chinese medicine composition for treating burns is proposed to solve the existing deficiencies. Summary of the Invention

[0023] The technical problem to be solved by the present invention is to overcome the above-mentioned technical defects and provide a traditional Chinese medicine composition for treating burns.

[0024] To solve the above technical problems, the technical solution provided by the present invention is a traditional Chinese medicine composition for treating burns: made from the following drugs in the following weight ratios: 10-20 parts of willow tree, 10-20 parts of jujube root, 10-15 parts of locust wood, 10-15 parts of elm wood, 10-25 parts of borneol, 500-800 parts of sesame oil, and 180-220 parts of yellow wax.

[0025] As an improvement, it is made from the following drugs in the following weight ratios: 15 parts of willow tree, 15 parts of jujube root, 12 parts of locust wood, 12 parts of elm wood, 17 parts of borneol, 650 parts of sesame oil, and 200 parts of yellow wax.

[0026] A preparation method of a traditional Chinese medicine composition for treating burns includes the following steps:

[0027] S1. Pretreatment of medicinal materials:

[0028] S1.1 Cleaning:

[0029] Rinse the willow tree, jujube root, locust wood, and elm wood separately with clean water to remove surface impurities and sediment, and dry naturally;

[0030] S1.2 Drying:

[0031] Put the dried willow, jujube roots, Chinese scholartrees, and elm woods into a traditional Chinese medicine grinder respectively, sieve through a 20-40 mesh sieve to obtain traditional Chinese medicine powder, then spread the traditional Chinese medicine powder evenly on a stainless steel tray, and place it in an oven at 50°C - 60°C to dry for 1.5 - 2 hours until the water content ≤ 8%;

[0032] S2. Low-temperature extraction:

[0033] S2.1 Sesame oil preheating:

[0034] Add sesame oil to a stainless steel double-layer pot and preheat it to 80°C;

[0035] S2.2 Feeding and decocting:

[0036] Put the pretreated traditional Chinese medicine powder in batches, keep the oil temperature at 80 ± 5°C and decoct slowly with continuous stirring, and stop heating when the medicinal materials turn dark brown after 35 - 40 minutes;

[0037] S2.3 Cold extraction and precipitation:

[0038] Cover and let stand for 24 hours to complete cold extraction and precipitation;

[0039] S3. Filtration:

[0040] Use a 200-mesh double-layer filter cloth in combination with a vacuum filtration device to filter the medicinal oil in three times. After the first filtration, let it stand and precipitate for 2 hours and then conduct the second filtration. Finally, obtain clarified reddish-brown medicinal oil with an oil yield ≥ 85%;

[0041] S4. Matrix fusion:

[0042] S4.1 Heating and melting:

[0043] Transfer the filtered medicinal oil to a constant temperature water bath, set the temperature at 75°C, and slowly add small pieces of yellow wax;

[0044] S4.2 Stirring and melting: Use a magnetic stirrer to stir evenly at 300 rpm, continuously heat for 20 - 25 minutes until completely melted to obtain a semi-fluid matrix;

[0045] S5. Shaping

[0046] S5.1 Adding borneol:

[0047] When the temperature of the matrix drops to 60°C, sprinkle the fine borneol powder evenly in three times;

[0048] S5.2 Stirring and dissolving:

[0049] Use a glass rod to stir unidirectionally and evenly, maintain a constant temperature of 55°C and stir for 10 - 15 minutes until completely dissolved;

[0050] S6. Sterilization and filling:

[0051] S6.1 Filtration and sterilization:

[0052] Under the condition of 55°C, terminal sterilization filtration is carried out with a 0.22μm microporous filter membrane;

[0053] S6.2 Filling:

[0054] Maintain liquid filling at 45°C into sterilized brown glass bottles.

[0055] The present invention also provides a traditional Chinese medicine composition, and the composition contains the above-mentioned composition or other pharmaceutically acceptable physical forms.

[0056] As an improvement, the traditional Chinese medicine composition is an aqueous solution or an ointment.

[0057] As an improvement, the present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a traditional Chinese medicine composition capable of treating scalds.

[0058] The pharmacological properties of each traditional Chinese medicine used are as follows:

[0059] Willow: Contains salicin, has significant anti-inflammatory effects, can also relieve pain, and is commonly used to treat mild to moderate pain. At the same time, willow extract has an inhibitory effect on certain bacteria. In this composition, willow can provide anti-inflammatory and analgesic effects, help relieve the inflammation and pain caused by scalds, and at the same time, cooperate with other components to enhance the overall therapeutic effect.

[0060] With jujube root, locust wood, elm wood: These components act together to enhance the anti-inflammatory and antibacterial effects.

[0061] With borneol: The cooling effect of borneol complements the anti-inflammatory effect of willow, further relieving the burning sensation caused by scalds.

[0062] With sesame oil, yellow wax: As a matrix, it helps to stabilize and slowly release the willow components.

[0063] Jujube root: Contains a variety of bioactive components, has antibacterial and antiviral effects, can inhibit the inflammatory response, reduce tissue damage, and at the same time contains components that promote cell proliferation and differentiation, helping wound healing. In this composition, jujube root can enhance the antibacterial and anti-inflammatory effects of the overall formula, and help the tissue repair and regeneration of the scalded area.

[0064] With willow, locust wood, elm wood: Act synergistically to enhance the anti-inflammatory and antibacterial effects.

[0065] With borneol: The cooling and antibacterial effects of borneol complement the antibacterial and wound-healing effects of jujube root.

[0066] With sesame oil, yellow wax: As a matrix, it helps to stabilize and slowly release the jujube root components.

[0067] Sophora japonica: It contains various alkaloids and flavonoid compounds, has antibacterial effects, can inhibit inflammatory reactions, reduce tissue damage, contains components that promote blood coagulation, and helps with hemostasis; in this composition, Sophora japonica can enhance the antibacterial and anti-inflammatory effects of the overall formula, help with hemostasis at the scald site, and reduce bleeding.

[0068] With willow, jujube root, and elm: They have a synergistic effect to enhance the anti-inflammatory and antibacterial effects.

[0069] With borneol: The cooling and antibacterial effects of borneol complement the antibacterial and hemostatic effects of Sophora japonica.

[0070] With sesame oil and yellow wax: As a matrix, it helps with the stability and slow release of the components of Sophora japonica.

[0071] Elm contains various bioactive components, has antibacterial effects, can inhibit inflammatory reactions, reduce tissue damage, contains components that promote cell proliferation and differentiation, and helps with wound healing. In this composition, elm can enhance the antibacterial and anti-inflammatory effects of the overall formula and assist in the tissue repair and regeneration at the scald site.

[0072] With willow, jujube root, and Sophora japonica: They have a synergistic effect to enhance the anti-inflammatory and antibacterial effects.

[0073] With borneol: The cooling and antibacterial effects of borneol complement the antibacterial and wound-healing effects of elm.

[0074] With sesame oil and yellow wax: As a matrix, it helps with the stability and slow release of the components of elm.

[0075] Borneol: It has a significant cooling sensation, can relieve the burning sensation caused by scalds, has inhibitory effects on various bacteria, can enhance the permeability of other drugs, and improve the therapeutic effect. In this composition, borneol can provide an immediate cooling sensation, relieve pain, while enhancing the antibacterial effect, help other components better penetrate the skin, and improve the overall therapeutic effect.

[0076] With willow, jujube root, Sophora japonica, and elm: They have a synergistic effect to enhance the antibacterial and anti-inflammatory effects.

[0077] With sesame oil and yellow wax: As part of the matrix, it helps with the stability and slow release of borneol.

[0078] Sesame oil has the effect of moisturizing the skin, can prevent skin dryness, contains antibacterial components, has inhibitory effects on certain bacteria, contains antioxidant components such as vitamin E, and helps protect the skin. In this composition, sesame oil acts as a solvent and matrix, dissolves and stabilizes other components, provides moisturizing and protective effects, and promotes wound healing

[0079] With all components: As a matrix, it dissolves and stabilizes other components.

[0080] Together with sesame oil: They jointly form a stable matrix to protect other ingredients.

[0081] Sesame oil: It has the effect of moisturizing the skin, can prevent skin dryness, contains antibacterial components, has an inhibitory effect on certain bacteria, forms a protective film on the skin surface, and protects the wound. In this composition, it jointly forms a stable matrix with yellow wax, dissolves and stabilizes other ingredients, forms a protective film on the skin surface, protects the wound, and prevents infection.

[0082] Together with yellow wax: They jointly form a stable matrix to protect other ingredients.

[0083] Together with all ingredients: As part of the matrix, it helps with the stability and slow release of other ingredients.

[0084] The advantages of the present invention compared with the prior art are as follows:

[0085] 1. The traditional Chinese medicine composition of the present invention is composed of seven ingredients: willow, jujube root, locust wood, elm wood, borneol, sesame oil and yellow wax, and there is a synergistic effect among the ingredients. Willow, jujube root, locust wood and elm wood are used as the core medicinal materials, rich in a variety of bioactive ingredients, having a significant antibacterial and anti-inflammatory effect, can effectively inhibit the growth and reproduction of common pathogenic microorganisms on the scald wound surface, and reduce the local inflammatory reaction. Borneol not only provides a cool feeling to relieve pain, but also enhances the permeability of other ingredients, improving the overall therapeutic effect. Sesame oil and yellow wax are used as the matrix. On the one hand, they can dissolve and stabilize other ingredients, and on the other hand, they form a protective film on the skin surface to prevent infection and promote wound healing. The ingredient compatibility of the present invention is scientific and reasonable, and the mechanism of action is clear and definite, which is more conducive to clinical application and promotion.

[0086] 2. The present invention uses a semi-fluid matrix, combining the advantages of ointment and gel. This dosage form not only has good adhesiveness, can closely adhere to the scald wound surface, but also is easy to apply and clean, and is convenient to use. In addition, the semi-fluid matrix can promote the release and absorption of drug ingredients, improve the bioavailability, and shorten the onset time. The dosage form design of the present invention is reasonable and can better meet the clinical needs.

[0087] 3. The traditional Chinese medicine composition of the present invention has multiple effects such as antibacterial and anti-inflammatory, pain relief, promoting healing, and reducing scar formation through the synergistic action of multiple ingredients and multiple targets. The present invention can effectively reduce the inflammatory reaction of the scald wound surface, promote the coverage of new epithelium, shorten the healing time, and reduce the risk of scar formation. The curative effect of the present invention is more comprehensive and remarkable.

[0088] 4. The Chinese medicinal materials used in the present invention all come from natural plants, and are processed through strict processing and extraction processes, removing most of the impurities and toxic components. The present invention has no obvious irritation to the skin and has high safety. Detailed implementation manners

[0089] The content of the present invention can be more easily understood by referring to the following detailed description of the preferred embodiments of the present invention and the included examples. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the definitions in this specification shall prevail.

[0090] As used herein, the term "composed of" is synonymous with "comprising". The terms "comprising", "including", "having", "containing" or any other variation thereof used herein are intended to cover non-exclusive inclusion. For example, a composition, step, method, article or apparatus containing the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article or apparatus.

[0091] The connecting phrase "consisting of" excludes any unstated element, step or component. If used in a claim, this phrase will render the claim closed, excluding materials other than those described, except for conventional impurities associated therewith. When the phrase "consisting of" appears in a clause of the claim body rather than immediately following the subject, it only limits the elements described in that clause; other elements are not excluded from the claim as a whole.

[0092] When an equivalent, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper preferred values and lower preferred values, this should be understood to specifically disclose all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value, whether or not the ranges are separately disclosed. For example, when the range "1 to 5" is disclosed, the described range should be interpreted to include the ranges "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within the range.

[0093] The singular form includes plural referents unless the context clearly indicates otherwise. "Optional" or "any one" means that the event or circumstance described thereafter may or may not occur, and the description includes both the case where the event occurs and the case where the event does not occur.

[0094] Approximate terms in the specification and claims are used to modify quantities, indicating that the present invention is not limited to the specific quantity, but also includes modified parts that are close to the quantity and acceptable without causing changes to relevant basic functions. Accordingly, modifying a numerical value with "about", "approximately", etc. means that the present invention is not limited to the exact numerical value. In some examples, the approximate term may correspond to the accuracy of the instrument for measuring the numerical value. In the specification and claims of the present application, range limitations can be combined and / or interchanged, and if not otherwise stated, these ranges include all sub-ranges contained therein.

[0095] In addition, the indefinite articles "a" and "an" before the elements or components of the present invention do not limit the quantity requirements (i.e., the number of occurrences) of the elements or components. Therefore, "a" or "an" should be interpreted as including one or at least one, and the singular form of the element or component also includes the plural form, unless the quantity clearly refers to the singular form.

[0096] "Polymer" means a polymeric compound prepared by polymerizing the same or different types of monomers. The general term "polymer" includes the terms "homopolymer", "copolymer", "terpolymer", and "copolymer blend". "Copolymer blend" means a polymer prepared by polymerizing at least two different monomers. The general term "copolymer blend" includes the term "copolymer" (which generally refers to a polymer prepared from two different monomers) and the term "terpolymer" (which generally refers to a polymer prepared from three different monomers). It also includes polymers manufactured by polymerizing more types of monomers. "Blend" means a polymer formed by physically or chemically mixing two or more polymers together.

[0097] In addition, any methods and materials similar or equivalent to the described content can be applied to the present invention. The preferred implementation methods and materials described in the text are for illustrative purposes only and do not limit the content of this application.

[0098] In the experimental methods in the following examples, unless otherwise specified, they are all conventional methods; in the test materials and test strains used in the following examples, unless otherwise specified, they are all purchased from commercial channels.

[0099] Example 1

[0100] A traditional Chinese medicine composition for treating scalds is made from the following drugs in the following weight ratios: 10 parts of willow, 10 parts of jujube root, 10 parts of locust tree, 10 parts of elm, 10 parts of borneol, 500 parts of sesame oil, and 180 parts of yellow wax.

[0101] A preparation method of a traditional Chinese medicine composition for treating scalds includes the following steps:

[0102] S1. Pretreatment of medicinal materials:

[0103] S1.1 Cleaning:

[0104] Rinse the willow, jujube roots, sophora wood, and elm wood separately with clean water, remove surface impurities and sediment, and air-dry naturally. Through cleaning and air-drying, remove the impurities and moisture on the surface of the medicinal materials, ensure the cleanliness and dryness of the medicinal materials, and prepare for the subsequent crushing and extraction steps.

[0105] S1.2 Drying:

[0106] Put the dried willow, jujube roots, sophora wood, and elm wood into a traditional Chinese medicine crusher respectively for crushing, pass through a 20-mesh sieve to obtain traditional Chinese medicine powder, then spread the traditional Chinese medicine powder evenly on a stainless steel tray, and place it in an oven at 50 °C for drying for 1.5 hours until the water content ≤ 8%;

[0107] In specific implementation, through crushing, the large pieces of medicinal materials are crushed into smaller particles, which is convenient for subsequent processing and extraction of active ingredients, and reducing the water content of the traditional Chinese medicine powder to ≤ 8% can prevent the medicinal materials from mildewing or deteriorating during subsequent storage and processing.

[0108] S2. Low-temperature extraction:

[0109] S2.1 Sesame oil preheating:

[0110] Add sesame oil to a stainless steel double-layer pot and preheat it to 80 °C;

[0111] In this embodiment, sesame oil is used as a solvent for the subsequent traditional Chinese medicine extraction process. By raising the temperature of the sesame oil, it can better dissolve and extract the active ingredients in the traditional Chinese medicine powder.

[0112] S2.2 Feeding and decocting:

[0113] Feed the pretreated traditional Chinese medicine powder in batches, keep the oil temperature at 75 °C and decoct slowly with continuous stirring, and stop heating when the medicinal materials turn dark brown after 35 minutes;

[0114] During implementation, feeding in batches can avoid excessive one-time feeding of traditional Chinese medicine powder, resulting in a sudden drop in oil temperature and affecting the extraction effect. Slow decocting can avoid local overheating, ensure uniform heating of the traditional Chinese medicine powder, fully extract the active ingredients, and ensure that the active ingredients in the traditional Chinese medicine powder are fully dissolved in the sesame oil.

[0115] S2.3 Cold extraction and precipitation:

[0116] Cover and let stand for 24 hours to complete cold extraction and precipitation;

[0117] During operation, due to the concentration difference between the traditional Chinese medicine powder and sesame oil, the active ingredients are slowly dissolved into the solvent. Specifically, cold extraction is carried out at a relatively low temperature to further dissolve the active ingredients in the traditional Chinese medicine powder into sesame oil. Through long-term standing, the concentration difference between the medicinal materials and sesame oil reaches equilibrium, ensuring that the active ingredients in the medicinal materials are fully dissolved into sesame oil.

[0118] S3. Filtration:

[0119] Use a 200-mesh double-layer filter cloth in combination with a vacuum filtration device to filter the medicinal oil in three times. After the first filtration, let it stand and precipitate for 2 hours before the second filtration. Finally, obtain a clarified reddish-brown medicinal oil with an oil yield ≥ 85%;

[0120] Specifically, through three times of filtration, solid impurities and suspended matters in the medicinal oil are removed to obtain clarified medicinal oil.

[0121] S4. Matrix fusion:

[0122] S4.1 Heating and melting:

[0123] Transfer the filtered medicinal oil to a constant temperature water bath, set it at 75 °C, and slowly add crushed yellow wax;

[0124] S4.2 Stirring and melting: Use a magnetic stirrer to stir evenly at 300 rpm, and continuously heat for 20 min until completely melted to obtain a semi-fluid matrix;

[0125] S5. Shaping

[0126] S5.1 Adding borneol:

[0127] When the temperature of the matrix drops to 60 °C, evenly sprinkle fine borneol powder in three times;

[0128] S5.2 Stirring and dissolving:

[0129] Use a glass rod to stir unidirectionally and evenly, maintain a constant temperature of 55 °C and stir for 10 min until completely dissolved;

[0130] S6. Sterilization and filling:

[0131] S6.1 Filtration and sterilization:

[0132] Under the condition of 55 °C, use a 0.22-μm microporous filter membrane for terminal sterilization filtration;

[0133] S6.2 Filling:

[0134] Maintain a liquid state at 45 °C and fill it into a sterilized brown glass bottle.

[0135] The present invention also provides a traditional Chinese medicine composition, and the composition comprises the above composition or other pharmaceutically acceptable physical forms.

[0136] Furthermore, the traditional Chinese medicine composition is in the form of a water-based preparation or an ointment.

[0137] Furthermore, the present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a traditional Chinese medicine composition capable of treating scalds.

[0138] Example 2

[0139] A traditional Chinese medicine composition for treating scalds is prepared from the following drugs in the following weight ratios: 15 parts of willow, 15 parts of jujube root, 12 parts of locust wood, 12 parts of elm wood, 17 parts of borneol, 650 parts of sesame oil, and 200 parts of yellow wax.

[0140] A preparation method of a traditional Chinese medicine composition for treating scalds includes the following steps:

[0141] S1. Pretreatment of medicinal materials:

[0142] S1.1 Cleaning:

[0143] Rinse the willow, jujube root, locust wood, and elm wood separately with clean water to remove surface impurities and sediment, and then air-dry them naturally; through cleaning and air-drying, remove the impurities and moisture on the surface of the medicinal materials to ensure the cleanliness and dryness of the medicinal materials, and prepare for the subsequent crushing and extraction steps.

[0144] S1.2 Drying:

[0145] Put the dried willow, jujube root, locust wood, and elm wood into a traditional Chinese medicine crusher respectively for crushing, and pass through a 30-mesh sieve to obtain traditional Chinese medicine powder. Then spread the traditional Chinese medicine powder evenly on a stainless steel tray and place it in an oven at 55°C for drying for 1.7 hours until the water content ≤ 8%;

[0146] In specific implementation, through crushing, the large pieces of medicinal materials are crushed into smaller particles, which is convenient for subsequent processing and extraction of active ingredients, and reducing the water content of the traditional Chinese medicine powder to ≤ 8% can prevent the medicinal materials from mildewing or deteriorating during subsequent storage and processing.

[0147] S2. Low-temperature extraction:

[0148] S2.1 Preheating of sesame oil:

[0149] Add sesame oil to a stainless steel double-layer pot and preheat it to 80°C;

[0150] In this embodiment, sesame oil is used as a solvent for the subsequent traditional Chinese medicine extraction process. By increasing the temperature of sesame oil, it can better dissolve and extract the active ingredients in the traditional Chinese medicine powder.

[0151] S2.2 Feeding and decocting:

[0152] Add the pre-treated Chinese medicine powder in batches, keep the oil temperature at 80℃ and simmer over low heat while stirring continuously. Stop the heat when the medicinal materials turn dark brown after 38 minutes.

[0153] During implementation, adding in batches can avoid adding too much Chinese medicine powder at one time, which will cause the oil temperature to drop suddenly and affect the extraction effect. Slow fire simmering can avoid local overheating, ensure that the Chinese medicine powder is evenly heated, fully extract the effective ingredients, and ensure that the effective ingredients in the Chinese medicine powder are fully dissolved in the sesame oil.

[0154] S2.3 Cold leaching precipitation:

[0155] Cover and let stand for 24 hours to complete cold leaching;

[0156] During operation, the effective ingredients are slowly dissolved into the solvent through the concentration difference between the Chinese medicine powder and the sesame oil. Specifically, cold leaching and precipitation are carried out at a relatively low temperature so that the effective ingredients in the Chinese medicine powder are further dissolved into the sesame oil. By standing still for a long time, the concentration difference between the medicinal materials and the sesame oil reaches a balance, thereby ensuring that the effective ingredients in the medicinal materials are fully dissolved in the sesame oil.

[0157] S3, Filtering:

[0158] Use a 200-mesh double-layer filter cloth with a vacuum filtration device to filter the medicinal oil three times. After the first filtration, let it settle for 2 hours and then filter it again, and finally obtain a clear brown-red medicinal oil with an oil yield of ≥85%;

[0159] Specifically, the solid impurities and suspended matter in the medicinal oil are removed by filtering three times to obtain clarified medicinal oil.

[0160] S4. Matrix fusion:

[0161] S4.1 Heating and melting:

[0162] Transfer the filtered medicinal oil to a constant temperature water bath, set to 75°C, and slowly add the yellow wax fragments;

[0163] S4.2 Stirring and melting: Use a magnetic stirrer to stir at a constant speed of 300 rpm and continue heating for 23 min until it is completely melted to obtain a semifluid matrix;

[0164] S5, Forming

[0165] S5.1 Add borneol:

[0166] When the substrate temperature drops to 60°C, sprinkle borneol powder evenly three times;

[0167] S5.2 Stirring to dissolve:

[0168] Use a glass rod to stir at a constant speed in one direction, maintain a constant temperature of 55°C and stir for 13 minutes until completely dissolved;

[0169] S6, Sterilization and filling:

[0170] S6.1 Filter sterilization:

[0171] At 55 °C, perform terminal sterilization filtration with a 0.22 μm microporous filter membrane;

[0172] S6.2 Filling:

[0173] Maintain at 45 °C in liquid state and fill into sterilized brown glass bottles.

[0174] The present invention also provides a traditional Chinese medicine composition, which comprises the above composition or other pharmaceutically acceptable physical forms.

[0175] Further, the traditional Chinese medicine composition is an aqueous solution or an ointment.

[0176] Further, the present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a traditional Chinese medicine composition capable of treating scalds.

[0177] Example 3

[0178] A traditional Chinese medicine composition for treating scalds is made from the following drugs in the following weight ratios: 20 parts of willow tree, 20 parts of jujube root, 15 parts of locust tree, 15 parts of elm tree, 25 parts of borneol, 800 parts of sesame oil, and 220 parts of yellow wax.

[0179] A preparation method of a traditional Chinese medicine composition for treating scalds comprises the following steps:

[0180] S1, Pretreatment of medicinal materials:

[0181] S1.1 Cleaning:

[0182] Rinse the willow tree, jujube root, locust tree, and elm tree separately with clean water to remove surface impurities and sediment, and air dry naturally; through cleaning and air drying, remove the impurities and moisture on the surface of the medicinal materials to ensure the cleanliness and dryness of the medicinal materials, and prepare for the subsequent crushing and extraction steps.

[0183] S1.2 Drying:

[0184] Put the dried willow tree, jujube root, locust tree, and elm tree into a traditional Chinese medicine crusher respectively for crushing, pass through a 40-mesh sieve to obtain traditional Chinese medicine powder, then spread the traditional Chinese medicine powder evenly on a stainless steel tray, and place it in an oven at 60 °C for drying for 1.5 - 2 hours until the water content ≤ 8%;

[0185] In specific implementation, through crushing, the large pieces of medicinal materials are crushed into smaller particles, which is convenient for subsequent processing and extraction of active ingredients, and reducing the water content of the traditional Chinese medicine powder to ≤ 8% can prevent the medicinal materials from mildewing or deteriorating during subsequent storage and processing.

[0186] S2. Low temperature extraction:

[0187] S2.1 Preheating sesame oil:

[0188] Add sesame oil to a stainless steel sandwich pot and preheat to 80°C;

[0189] In this embodiment, sesame oil is used as a solvent in the subsequent Chinese medicine extraction process. By increasing the temperature of the sesame oil, it can better dissolve and extract the effective ingredients in the Chinese medicine powder.

[0190] S2.2 Feeding and refining:

[0191] Add the pre-treated Chinese herbal powder in batches, keep the oil temperature at 85℃ and simmer over low heat while stirring continuously. Stop the heat when the herbal material turns dark brown after 40 minutes.

[0192] During implementation, adding in batches can avoid adding too much Chinese medicine powder at one time, which will cause the oil temperature to drop suddenly and affect the extraction effect. Slow fire simmering can avoid local overheating, ensure that the Chinese medicine powder is evenly heated, fully extract the effective ingredients, and ensure that the effective ingredients in the Chinese medicine powder are fully dissolved in the sesame oil.

[0193] S2.3 Cold leaching precipitation:

[0194] Cover and let stand for 24 hours to complete cold leaching;

[0195] During operation, the effective ingredients are slowly dissolved into the solvent through the concentration difference between the Chinese medicine powder and the sesame oil. Specifically, cold leaching and precipitation are carried out at a relatively low temperature so that the effective ingredients in the Chinese medicine powder are further dissolved into the sesame oil. By standing still for a long time, the concentration difference between the medicinal materials and the sesame oil reaches a balance, thereby ensuring that the effective ingredients in the medicinal materials are fully dissolved in the sesame oil.

[0196] S3, Filtering:

[0197] Use a 200-mesh double-layer filter cloth with a vacuum filtration device to filter the medicinal oil three times. After the first filtration, let it settle for 2 hours and then filter it again, and finally obtain a clear brown-red medicinal oil with an oil yield of ≥85%;

[0198] Specifically, the solid impurities and suspended matter in the medicinal oil are removed by filtering three times to obtain clarified medicinal oil.

[0199] S4. Matrix fusion:

[0200] S4.1 Heating and melting:

[0201] Transfer the filtered medicinal oil to a constant temperature water bath, set to 75°C, and slowly add the yellow wax fragments;

[0202] S4.2 Stirring and melting: Use a magnetic stirrer to stir evenly at 300 rpm, continuously heat for 25 min until completely melted to obtain a semi-fluid matrix;

[0203] S5. Shaping

[0204] S5.1 Adding borneol:

[0205] When the temperature of the matrix drops to 60 °C, evenly sprinkle the fine powder of borneol in three portions;

[0206] S5.2 Stirring and dissolving:

[0207] Use a glass rod to stir unidirectionally and evenly, maintain constant temperature stirring at 55 °C for 15 min until completely dissolved;

[0208] S6. Sterilization and filling:

[0209] S6.1 Filtration and sterilization:

[0210] Under the condition of 55 °C, use a 0.22 μm microporous membrane for terminal sterilization filtration;

[0211] S6.2 Filling:

[0212] Keep it in a liquid state at 45 °C and fill it into a sterilized brown glass bottle.

[0213] The present invention also provides a traditional Chinese medicine composition, and the composition contains the above composition or other pharmaceutically acceptable physical forms.

[0214] Furthermore, the traditional Chinese medicine composition is in the form of an aqueous solution or an ointment.

[0215] Furthermore, the present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a traditional Chinese medicine composition capable of treating scalds.

[0216] In order to better illustrate the technical effects of the present invention, the following experimental verifications are carried out.

[0217] Experiment 1: In vitro antibacterial experiment

[0218] 1) Bacterial strain preparation:

[0219] Take fresh bacterial solutions of Staphylococcus aureus (ATCC 25923) and Escherichia coli (ATCC 25922), and adjust them to 0.5 McFarland turbidity (1×10^8 CFU / mL) with physiological saline;

[0220] 2) Preparation of medicinal liquid:

[0221] Take 1 g of the ointment and dissolve it in 10 mL of sterile liquid paraffin, vortex and mix evenly to obtain a 10% medicinal liquid;

[0222] 3) Agar punching method:

[0223] Uniformly spread the bacterial solution on the MH agar plate;

[0224] Use a sterile punch (6 mm in diameter) to punch holes in the plate, and add 50 μL of the medicinal solution to each hole;

[0225] Cultivate for 18 hours at 37 °C, and measure the diameter of the inhibition zone.

[0226] The results are shown in Table 1:

[0227]

[0228] Conclusion: The traditional Chinese medicine composition of the present invention has a significant antibacterial effect on Gram-positive bacteria (such as Staphylococcus aureus) and Gram-negative bacteria (such as Escherichia coli).

[0229] Experiment 2: Skin irritation test

[0230] 1) Animal grouping:

[0231] Select 6 healthy New Zealand rabbits, depilate the back (4×4 cm area)

[0232] Divide them into a complete skin group (left side) and a damaged skin group (right side, abraded with sandpaper until bleeding)

[0233] 2) Drug administration:

[0234] Apply 0.5 g of the ointment daily for 7 consecutive days;

[0235] The blank control group applies physiological saline;

[0236] Scoring criteria:

[0237] Erythema / edema score: 0 points (none) - 4 points (severe ulceration)

[0238]

[0239] Conclusion: The traditional Chinese medicine composition of the present invention has no irritation to the complete skin, and the damaged skin shows reversible mild irritation (recovery after 3 days of drug withdrawal).

[0240] Experiment 3: Animal scald test

[0241] 1) Experimental animals

[0242] Healthy SD rats, SPF grade, weighing 200 ± 20 g, male. After 1 week of adaptive feeding of the rats, the rats are randomly divided into 4 groups, namely the model control group (coated with vaseline matrix), the positive control group (sulfadiazine silver cream), the low-dose group (0.1 g / cm 2 Example 2 preparation), and the high-dose group (0.2 g / cm 2 Example 2 preparation), with 8 rats in each group, once a day.

[0243] 2) Establishment of scald model

[0244] 2.1 Preoperative treatment:

[0245] Anesthetize by intraperitoneal injection of 10% chloral hydrate (3 mL / kg);

[0246] Shave the back hair (in the area of 6×6 cm) and apply conductive paste;

[0247] 2.2 Scald operation:

[0248] Vertically press the preheated copper hot head (100 °C) on the exposed skin;

[0249] Pressure: 300 g / cm 2 (Precisely controlled by weights);

[0250] Time: 10 seconds (standard for deep second-degree scald);

[0251] Then immediately rinse and cool with ice-cold normal saline;

[0252] 2.3 Wound surface confirmation:

[0253] Macroscopic observation: Pale eschar forms, without bleeding points;

[0254] Pathological section: Full-thickness necrosis of the epidermis and partial coagulative necrosis of the dermis;

[0255] 3) Observation indexes and data collection

[0256] 3.1 Macroscopic observation (recorded daily)

[0257]

[0258] 3.2 Histopathology (HE staining)

[0259]

[0260] 3.3 Collagen deposition analysis (Masson staining)

[0261]

[0262] Note: # indicates P < 0.05 compared with the model control group, and ## indicates P < 0.01

[0263] Conclusion:

[0264] Collagen maturity: The ratio of type I / III collagen in the high-dose group is close to that of normal skin (normal value ≈ 3.5 - 4.0), indicating a reduced risk of scar formation.

[0265] 3.4 Test results

[0266]

[0267] Conclusion:

[0268] Time shortening effect: The healing time of the high-dose group was shortened by 37.9% compared with the model group (P < 0.01), and it was better than the positive control group (shortened by 7.8%). This traditional Chinese medicine composition accelerates healing through multi-target synergy.

[0269] Inflection point of healing rate: Newly formed epithelium coverage (50%) appeared on the 7th day in the high-dose group, about 10 days earlier than the model group, indicating a significant early effect on promoting epithelialization.

[0270] Anti-inflammatory effect: The level of TNF-α decreased by 51.9% (P < 0.001), and the level of IL-6 decreased by 52.9% (P < 0.01), indicating that this traditional Chinese medicine composition significantly inhibits the pro-inflammatory cytokine storm.

[0271] Promoting angiogenesis: The expression of VEGF increased by 159% (P < 0.01), higher than 128% in the positive control group, suggesting that this traditional Chinese medicine composition (such as sophoraflavone) promotes angiogenesis by activating the HIF-1α pathway.

[0272] The above describes the present invention and its implementation manners. This description is not restrictive, and what is shown is only one of the implementation manners of the present invention. The actual structure is not limited thereto. Generally speaking, if those of ordinary skill in the art are inspired by it and design similar structural manners and embodiments without creative efforts without departing from the gist of the present invention, they shall fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating scalds, characterized in that, It is made from the following drugs in the following weight ratios: 10-20 parts of willow, 10-20 parts of jujube root, 10-15 parts of sophora wood, 10-15 parts of elm, 10-25 parts of borneol, 500-800 parts of sesame oil, and 180-220 parts of yellow wax.

2. The traditional Chinese medicine composition for treating scalds according to claim 1, wherein: It is made from the following drugs in the following weight ratios: 15 parts of willow, 15 parts of jujube root, 12 parts of sophora wood, 12 parts of elm, 17 parts of borneol, 650 parts of sesame oil, and 200 parts of yellow wax.

3. A preparation method of a traditional Chinese medicine composition for treating scalds, characterized in that, It includes the following steps: S1. Pretreatment of medicinal materials: S1.1 Cleaning: Rinse the willow, jujube root, sophora wood, and elm with clean water respectively, remove the surface impurities and sediment, and air dry naturally; S1.2 Drying: Put the dried willow, jujube root, sophora wood, and elm into a traditional Chinese medicine grinder respectively for grinding, pass through a 20-40 mesh sieve to obtain traditional Chinese medicine powder, then spread the traditional Chinese medicine powder evenly on a stainless steel tray, and place it in an oven at 50°C - 60°C for drying for 1.5 - 2 hours until the water content ≤ 8%; S2. Low-temperature extraction: S2.1 Preheating of sesame oil: Add sesame oil to a stainless steel double-layer pot and preheat it to 80°C; S2.2 Charging and decocting: Put the pretreated traditional Chinese medicine powder in batches, keep the oil temperature at 80 ± 5°C and decoct slowly with continuous stirring, and stop heating when the medicinal materials turn dark brown after 35 - 40 minutes; S2.3 Cold extraction and precipitation: Cover and let stand for 24 hours to complete cold extraction and precipitation; S3. Filtration: Use a 200-mesh double-layer filter cloth in combination with a vacuum filtration device to filter the medicinal oil in three times. After the first filtration, let it stand and precipitate for 2 hours and then conduct the second filtration. Finally, obtain a clarified reddish-brown medicinal oil with an oil yield ≥ 85%; S4. Matrix fusion: S4.1 Heating and melting: Transfer the filtered medicinal oil to a constant temperature water bath, set the temperature at 75°C, and slowly add yellow wax chips; S4.2 Stirring and melting: Use a magnetic stirrer to stir evenly at 300 rpm, continuously heat for 20 - 25 minutes until completely melted to obtain a semi-fluid matrix; S5. Shaping S5.1 Adding borneol: When the temperature of the matrix drops to 60°C, sprinkle the fine borneol powder evenly in three times; S5.2 Stirring and dissolving: Use a glass rod to stir unidirectionally and evenly, maintain a constant temperature of 55°C and stir for 10 - 15 minutes until completely dissolved; S6. Sterilization and filling: S6.1 Filter sterilization: Under the condition of 55°C, conduct terminal sterilization filtration with a 0.22μm microporous filter membrane; S6.2 Filling: Keep it in a liquid state at 45°C and fill it into a sterilized brown glass bottle.

4. A traditional Chinese medicine composition for treating burns, wherein the traditional Chinese medicine composition comprises the drug according to any one of claims 1-2 or the drug obtained by the preparation method according to claim 3 or other pharmaceutically acceptable physical forms.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The traditional Chinese medicine composition is in the form of a water-based agent or an ointment.

6. Use of the traditional Chinese medicine composition according to any one of claims 1-2 or the traditional Chinese medicine composition obtained by the preparation method according to claim 3 in the preparation of a traditional Chinese medicine composition capable of treating burns.

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