An external ointment for burns and scalds and its preparation method

Abstract

The application discloses an external ointment for treating burns and scalds and a preparation method thereof. The external ointment comprises a base and a traditional Chinese medicine composition super-micron powder. The traditional Chinese medicine composition comprises the following components in parts by weight: Huanglian 1-5 parts, Huangqi 1-5 parts, Huangbo 1-5 parts, Dilong 0.5-1.5 parts, Dajiugen 1-5 parts and Xianrenzong 1-5 parts. The base is an oil-in-water base and comprises the following components in parts by weight: glycerol 1-9 parts, triethanolamine 0.1-0.5 parts, 1,2-propylene glycol 0.5-5 parts, ethyl parahydroxybenzoate 0.01-0.3 parts, water 10-50 parts, white beeswax 0.2-5 parts, lanolin 1-10 parts, stearic acid 2-20 parts and glycerol monostearate 1-10 parts. The traditional Chinese medicine composition uses Huanglian, Huangqi and Huangbo as main effective components, and is combined with Dilong, Xianrenzong and Dajiugen, so that the traditional Chinese medicine composition has the effects of clearing heat and toxic material, dispersing blood stasis and eliminating muscle knot in the process of repairing burn and scald wound surface.

Description

[0001] This invention patent application is a divisional application of the invention patent application filed on October 24, 2022, with application number 202211304504.3 and invention title "A Traditional Chinese Medicine Composition for Wound Healing and Its Preparation and Application". Technical Field

[0002] This invention relates to the field of traditional Chinese medicine, specifically to a topical ointment for burns and scalds and its preparation method. Background Technology

[0003] Wound healing is an important topic in trauma (burn) surgery. Skin trauma is unavoidable in life, and burns, as a common disease in daily life, are characterized by their widespread and frequent occurrence in the field of human medicine. The wound healing mechanism of burns remains a hot topic and a challenge in current research.

[0004] In terms of treatment, depending on the severity of burns, Western medicine plays an important role with anti-infective drugs and biological agents. However, due to the exceptionally complex healing process of burn wounds, the weaknesses of Western medicine—its singular approach and lack of comprehensive therapeutic effect—become apparent. Currently, traditional Chinese medicine (TCM) preparations for burns are constantly being innovated, with TCM prescriptions and preparation processes continuously being optimized, gradually demonstrating the significant advantages of TCM preparations in external treatments for wound healing.

[0005] Currently, there are many types of traditional Chinese medicine preparations available on the market for treating burns. However, practice has shown that most of these preparations fail to effectively restore the physiological function of the burned wound. Summary of the Invention

[0006] To address the aforementioned deficiencies in the prior art, this invention provides a traditional Chinese medicine composition and preparation for wound repair, which can effectively promote the healing of burn wounds, reduce scarring, and control inflammation. This invention also provides a method for preparing the aforementioned traditional Chinese medicine preparation, and the application of this traditional Chinese medicine composition in wound repair medications.

[0007] To achieve the above objectives, a first aspect of the present invention provides a traditional Chinese medicine composition for wound healing, comprising the following traditional Chinese medicine components in parts by weight:

[0008] Coptis chinensis 1-10 parts, Scutellaria baicalensis 1-10 parts, Phellodendron chinense 1-10 parts, Pheretima aspergillum 0.5-5 parts, Cirsium japonicum root 1-10 parts, Prickly pear cactus 1-10 parts.

[0009] The traditional Chinese medicine composition provided by this invention mainly comprises Coptis chinensis, Phellodendron chinense, and Scutellaria baicalensis. These three components are widely used in medications for treating burns and scalds. The 2020 edition of the Chinese Pharmacopoeia records that Coptis chinensis and Phellodendron chinense can be used externally. Furthermore, Scutellaria baicalensis, Coptis chinensis, and Phellodendron chinense are common heat-clearing and detoxifying herbs, all of which are bitter and cold in nature, possessing the functions of clearing heat and drying dampness, purging fire and detoxifying. They are often used in combination to enhance their heat-clearing and detoxifying effects. Modern pharmacological studies have shown that they possess anti-inflammatory, antioxidant, free radical scavenging, anti-platelet aggregation, and pathogenic microbial proliferation-inhibiting effects. In addition, the traditional Chinese medicine composition provided by this invention also contains earthworm, cactus, and Cirsium japonicum root; these three components have immunomodulatory and anti-fibrotic effects. Through the synergistic effect of the above-mentioned components, the traditional Chinese medicine composition provided by this invention can effectively clear heat and toxins, disperse blood stasis, and dissipate muscle nodules during the repair of burn and scald wounds.

[0010] By further optimizing the formulation of the above-mentioned traditional Chinese medicine composition, the advantages of the interaction of multiple components, multiple targets, and multiple pathways of traditional Chinese medicine can be further utilized to promote wound healing, reduce scarring, and control inflammation. Therefore, it is of great significance for the clinical treatment of wound repair-related diseases. In a preferred embodiment, the traditional Chinese medicine composition for wound repair includes the following components in parts by weight: Coptis chinensis 1-5 parts, Scutellaria baicalensis 1-5 parts, Phellodendron chinense 1-5 parts, Pheretima aspergillum 0.5-1.5 parts, Cirsium japonicum root 1-5 parts, and Opuntia ficus-indica 1-5 parts. In particular, the effect is better when the amounts of Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Cirsium japonicum root, and Opuntia ficus-indica are basically equal, and the amount of Pheretima aspergillum is slightly less than the aforementioned five traditional Chinese medicine components. For example, the formula of the above-mentioned traditional Chinese medicine components is Coptis chinensis 2-3 parts, Scutellaria baicalensis 2-3 parts, Phellodendron chinense 2-3 parts, Pheretima aspergillum 0.5-1.5 parts, Cirsium japonicum root 2-3 parts, and Opuntia ficus-indica 2-3 parts. In the specific implementation process, the composition of the traditional Chinese medicine composition includes: 2.5 parts by weight of Coptis chinensis, 2.5 parts by weight of Scutellaria baicalensis, 2.5 parts by weight of Phellodendron chinense, 1.0 part by weight of Pheretima aspergillum, 2.5 parts by weight of Cirsium japonicum root, and 2.5 parts by weight of Opuntia ficus-indica.

[0011] A second aspect of the present invention provides a traditional Chinese medicine preparation for wound healing, comprising granules of the traditional Chinese medicine composition described in the first aspect, or comprising an extract of the traditional Chinese medicine composition described in the first aspect.

[0012] Specifically, the particles of the aforementioned traditional Chinese medicine composition can be powder particles obtained by pulverizing or grinding each traditional Chinese medicine component, and especially can be ultrafine powders of each traditional Chinese medicine component. For example, each traditional Chinese medicine component can be micronized and then mixed in a certain proportion to obtain an ultrafine powder mixture. The extract of the aforementioned traditional Chinese medicine composition can be an extract obtained by extracting the traditional Chinese medicine composition using any feasible extraction method in the field of traditional Chinese medicine. For example, an aqueous decoction obtained by extracting the traditional Chinese medicine composition using a decoction method, or an extract obtained by soaking in a solvent such as ethanol, or a concentrated product obtained by further concentrating the above-mentioned aqueous decoction or extract.

[0013] Considering that ultrafine powder of traditional Chinese medicine can fully dissolve the active ingredients in the medicinal components, ensuring high absorption rate and good efficacy, the active ingredients are in the form of ultrafine powder in a preferred embodiment of the present invention. That is, the traditional Chinese medicine preparation for wound healing includes ultrafine powder of each medicinal component, or may further include pharmaceutically acceptable excipients.

[0014] External application of traditional Chinese medicine (TCM) refers to the use of Chinese medicine, guided by TCM theory, to enter the body through the skin and mucous membranes of bodily cavities, achieving the purpose of preventing and treating diseases. The TCM preparation provided by this invention can be in the common dosage forms of burn and scald medications, such as the following:

[0015] (1) Semi-solid dosage forms: such as pastes, ointments, oils and gels, with a uniform and delicate appearance, and possessing adhesiveness and chemical stability;

[0016] (2) Liquid preparations: such as decoctions, tinctures, fluid extracts and extracts, can increase drug dispersibility and reduce the irritation of some drugs, but their chemical stability is slightly poor. At the same time, liquid preparations are large in volume, making them inconvenient to carry, transport and store. Aqueous liquid preparations are prone to mold growth and require the addition of preservatives.

[0017] (3) Gaseous dosage forms: such as sprays and aerosols, have stable, rapid-acting and targeted effects, but are prone to causing drug waste;

[0018] (4) Solid dosage form: such as powder, the dosage can be adjusted according to the severity of symptoms, and it is convenient to transport, carry and use. The preparation method is simple and the utilization rate of medicinal materials is high. However, the effective ingredients of the drug are easily destroyed by high temperature, and the dosage is also difficult to control.

[0019] Considering the viscosity of ointments, they gradually soften or melt after application, allowing for slow absorption and sustained therapeutic effect, making them suitable for surgical sores, boils, burns, and scalds. Therefore, in the preferred embodiment, this traditional Chinese medicine preparation uses a semi-solid dosage form, particularly an ointment. External ointments include ointments, plasters, and adhesive plasters.

[0020] Ointments are semi-solid topical preparations with a certain consistency, made by uniformly mixing a drug with a suitable base. Common bases for ointments include three categories: water-soluble bases, oil-based bases, and emulsion bases. Ointments made with emulsion bases are also called creams. Emulsion bases are formed by emulsifying an oil phase and a water phase at a certain temperature using an emulsifier. They can be divided into water-in-oil emulsions (W / O) and oil-in-water emulsions (O / W).

[0021] The experimental results show that, for the above-mentioned traditional Chinese medicine components in this patent, especially the ultrafine powder mixture of each component, when an O / W type emulsion, i.e., an O / W type matrix, is used, the cream exhibits excellent appearance and stability, and demonstrates a more prominent effect on the healing of burn wounds, significantly superior to other types of matrices. In particular, when the selected matrix includes the following components, not only can a uniform, fine, and stable cream be obtained, but it can also effectively promote the healing of burn wounds, reduce scarring, and control inflammation: glycerin, triethanolamine, 1,2-propanediol, ethylparaben, water, white beeswax, lanolin, stearic acid, and glyceryl monostearate.

[0022] According to the quality evaluation standards for ointments, a single-factor study was conducted to investigate the influence of each matrix component index on the overall quality score of the ointment, and a preliminary matrix formulation was selected. For example, within a certain dosage range, as the dosage of stearic acid increases, the ointment becomes drier and harder; however, as the dosage of stearic acid decreases, the ointment separates into layers upon centrifugation, with a pale yellow foam forming on the top layer. As the dosage of glyceryl monostearate increases, the ointment's spreadability decreases; however, as the dosage of glyceryl monostearate decreases, the ointment becomes uneven in color after centrifugation, and the pH value increases. As the dosage of the emulsifier triethanolamine increases, the ointment's pH value increases significantly; however, as the dosage of triethanolamine decreases, the ointment exhibits obvious granular appearance, separates upon centrifugation, and has very poor physical stability. In addition, the dosage of other components in the matrix will also affect the quality of the ointment to varying degrees.

[0023] Further orthogonal experiments and analysis of variance were conducted, using the overall score of the ointment as the dependent variable, to identify several factors that significantly affected the ointment's formation. These factors were: stearic acid, glyceryl monostearate, the emulsifier triethanolamine, and emulsification temperature. Among these, triethanolamine had a significant impact on the ointment quality (P<0.05), followed by stearic acid and glyceryl monostearate; other factors (i.e., other ingredients) had a relatively low impact on the ointment.

[0024] Based on the above investigation and analysis results, and considering factors such as efficacy, the matrix composition is determined as follows: 1-9 parts glycerin, 0.1-0.5 parts triethanolamine, 0.5-5 parts 1,2-propanediol, 0.01-0.3 parts ethylparaben, and 10-50 parts water; 0.2-5 parts beeswax, 1-10 parts lanolin, 2-20 parts stearic acid, and 1-10 parts glyceryl monostearate; in addition, the weight and specific amount of each herbal component's ultrafine powder can be 0.1-1 parts by weight. In particular, after further verification and adjustment through specific experimental examples, the optimal matrix ratio was determined to be: 1-9 parts glycerol, 0.15-0.30 parts triethanolamine, 0.5-1.5 parts 1,2-propanediol, 0.04-0.15 parts ethylparaben, and 15.5-18.5 parts water; 0.2-1.8 parts white beeswax, 1-3 parts lanolin, 2-4 parts stearic acid, and 1-2 parts glyceryl monostearate. The mixture of white beeswax, lanolin, stearic acid, and glyceryl monostearate is designated as "O" in the O / W matrix, while the mixture of glycerol, triethanolamine, 1,2-propanediol, ethylparaben, and water is designated as "W" in the O / W matrix.

[0025] Reasonably controlling the mass concentration of ultrafine powder in the ointment, or the ratio between ultrafine powder and O / W type matrix, is beneficial to the release of effective components in the traditional Chinese medicine components, so as to achieve the best therapeutic effect. In the specific implementation process, based on a total ointment mass of 30 parts by weight, the total weight of ultrafine powder of each traditional Chinese medicine component is 0.60 to 0.75 parts by weight.

[0026] In a preferred embodiment, based on a total ointment weight of 30 parts by weight, the traditional Chinese medicine ultrafine powder comprises 0.60–0.75 parts by weight, and the base composition is as follows: 2–4 parts stearic acid, 1–2 parts glyceryl monostearate, 0.15–0.30 parts triethanolamine, 0.2–1.8 parts beeswax, 1–3 parts lanolin, 1–9 parts glycerin, 0.5–1.5 parts 1,2-propanediol, 0.04–0.15 parts ethylparaben, and sufficient water to make up the difference. In particular, controlling the triethanolamine content to 0.20–0.30 parts, especially 0.20–0.25 parts, is more conducive to obtaining an ointment with excellent overall performance and ensures the ointment's healing effect on burn wounds.

[0027] In the specific implementation process, the single herb can first be pulverized into ultrafine powder, passed through a 100-mesh sieve, and mixed evenly in a certain proportion; finally, the ultrafine powder is mixed with the above-mentioned O / W type matrix to form an ointment. The specific preparation process can adopt existing ointment preparation technology.

[0028] In the specific implementation process, the second mixture (aqueous phase and ultrafine powder) is poured into the first mixture (oil phase), emulsified, and then cooled to obtain an ointment. The first mixture is obtained by melting and mixing components including beeswax, lanolin, stearic acid, and glyceryl monostearate in a specific ratio. The second mixture is obtained by mixing components including glycerin, triethanolamine, 1,2-propanediol, ethylparaben, and water, along with the ultrafine powder, in a specific ratio. Preferably, controlling the emulsification temperature within the range of 75–85°C, especially within the range of 80–85°C, is more conducive to obtaining a uniform, delicate, and stable traditional Chinese medicine compound ointment.

[0029] A third aspect of the present invention provides a method for preparing a traditional Chinese medicine preparation for wound healing, comprising: processing the aforementioned traditional Chinese medicine components into a target dosage form.

[0030] Specifically, the appropriate processing steps can be selected based on the target dosage form, such as semi-solid, liquid, gaseous, or solid dosage forms. Of course, depending on the target dosage form, pharmaceutically acceptable excipients can also be added during processing.

[0031] For example, if the target dosage form is a decoction, the herbal raw materials can be placed in a container, and water with a weight of 2 to 16 times the weight of the herbs can be added. The decoction can be prepared by boiling and extracting the liquid 2 to 3 times. After removing the residue, the liquid can be combined to prepare the decoction. Alternatively, if the target dosage form is a powder, the powder obtained by grinding the various herbal components can be mixed evenly.

[0032] For example, if the target dosage form is an ointment, a base required for forming the ointment is added during the processing. Practice has shown that, compared to other types of bases, oil-in-water bases are more suitable for the release of the effective components of the aforementioned traditional Chinese medicine ingredients and can produce ointments with more stable performance, thereby promoting wound healing and reducing scarring.

[0033] In practice, the process of preparing the ointment includes the following steps:

[0034] The first component is melted and mixed evenly to obtain the first mixture;

[0035] The second component and the ultrafine powders of each traditional Chinese medicine component are mixed evenly to obtain a second mixture; and

[0036] While maintaining stirring, the second mixture is poured into the first mixture, emulsified, and then cooled to obtain a paste;

[0037] The first component comprises the following components in parts by weight: 0.2-5 parts white beeswax, 1-10 parts lanolin, 2-20 parts stearic acid, and 1-10 parts glyceryl monostearate; the second component comprises the following components in parts by weight: 1-9 parts glycerin, 0.1-0.5 parts triethanolamine, 0.5-5 parts 1,2-propanediol, 0.01-0.3 parts ethylparaben, and 10-50 parts water; the total mass of the ultrafine powder can be 0.1-1 parts.

[0038] In a preferred embodiment, the first component comprises the following components in parts by weight: 0.2-1.8 parts white beeswax, 1-3 parts lanolin, 2-4 parts stearic acid, and 1-2 parts glyceryl monostearate; the second component comprises the following components in parts by weight: 1-9 parts glycerin, 0.15-0.25 parts triethanolamine, 0.5-1.5 parts 1,2-propanediol, 0.04-0.15 parts ethylparaben, and 15.5-18.5 parts water; the total mass of the ultrafine powder can be 0.6-0.75 parts.

[0039] Further research has shown that, in addition to the composition ratio of the matrix, the preparation process also affects the quality of the final ointment, especially the emulsification temperature. Using the matrix components with the above-mentioned ratio, when the emulsification temperature is controlled at 75–85℃, especially 80–85℃, the resulting ointment exhibits highly desirable quality, achieving optimal overall performance and therapeutic effect.

[0040] A fourth aspect of the invention provides the use of the traditional Chinese medicine composition described in the first aspect in the preparation of a medicament for wound healing. In particular, it is used in the preparation of a medicament for wound healing caused by burns and scalds.

[0041] The traditional Chinese medicine composition and preparation for wound repair provided by this invention use Coptis chinensis, Scutellaria baicalensis and Phellodendron chinense as the main effective ingredients, combined with earthworm, cactus and Cirsium japonicum root. Through the rational combination and synergistic effect of each traditional Chinese medicine component, the traditional Chinese medicine composition and preparation can play the role of clearing heat and toxins, dispersing blood stasis and eliminating muscle knots in the process of repairing burn wounds.

[0042] In particular, by selecting the ointment formulation and the optimal base ratio, the resulting ointment achieved a better overall score and effectively restored the physiological function of burn wounds. The effect of this ointment on promoting the healing of burn wounds was studied in a C57BL / 6J mouse burn model. The results showed that the ointment promoted rapid healing of burn wounds, reduced scarring, and controlled inflammation, with effects superior to commonly available burn ointments and the control group.

[0043] The method for preparing a traditional Chinese medicine preparation for wound repair provided by this invention, by selecting the optimal matrix ratio and the optimal process, especially by exploring the optimal emulsification temperature, results in an ointment with a better overall score, which can effectively promote rapid wound healing, effectively reduce scarring and control inflammation.

[0044] Because the above-mentioned traditional Chinese medicine composition has the effects described above, it can be applied to drugs for wound healing and has a very broad application prospect. Attached Figure Description

[0045] Figure 1 Photographs showing the appearance of the ointments prepared in Example 2 and Comparative Examples 1-3;

[0046] Figure 2 These are photographs showing the apparent healing of burn wounds in the four groups of mice in the experimental case.

[0047] Figure 3 The curves show the changes in the healing rate of burn wounds in the four groups of mice in the experiment.

[0048] Figure 4 The pathological sections (4×) of the scald junctions in the four groups of mice in the experimental case were taken on the 7th day after drug administration.

[0049] Figure 5 The pathological sections (10×) of the scald junctions in the four groups of mice in the experimental case on day 14 after drug administration.

[0050] Figure 6 The images show pathological sections (20×) of the scald junctions in the four groups of mice on day 21 of drug administration in the experimental case. Detailed Implementation

[0051] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are not all embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0052] Example 1

[0053] This embodiment provides a traditional Chinese medicine composition comprising the following components: 2.5g Coptis chinensis, 2.5g Scutellaria baicalensis, 2.5g Phellodendron chinense, 1g Pheretima aspergillum, 2.5g Cirsium japonicum root, and 2.5g Opuntia ficus-indica.

[0054] The single herb is pulverized into ultrafine powder, passed through a 100-mesh sieve, and then the ultrafine powder of the single herb is accurately weighed according to the above-mentioned quality and mixed.

[0055] Example 2

[0056] This embodiment provides an O / W type cream, the preparation method of which is as follows:

[0057] Add 1 g of white beeswax, 2 g of lanolin, 3 g of stearic acid, and 1.5 g of glyceryl monostearate to a dry 100 mL beaker (referred to as beaker A). Place the beaker in a glass water bath and heat it, keeping the water bath temperature constant at 75 ℃. Stir at 550 r / min until completely melted.

[0058] Take another 100 mL dry beaker (referred to as beaker B), add 5 g of glycerin, 15.53 g of distilled water, 0.2 g of triethanolamine, 1 g of 1,2-propanediol, 0.09 g of ethylparaben, and 0.68 g of the ultrafine powder from Example 1, and stir thoroughly until homogeneous;

[0059] Place beaker B in a glass water bath and control the water bath temperature at 75°C. Heat and stir for about 10 minutes. Then, while stirring, add the mixture from beaker A to beaker B and mix thoroughly. After emulsifying at 75°C and 550 r / min for 10 minutes, stop heating and continue stirring until cooled to room temperature.

[0060] Comparative Example 1

[0061] This comparative example provides an oily ointment, which is prepared as follows: a glass jar containing an appropriate amount of water is preheated to 70 ℃ on a magnetic stirrer and the temperature is kept stable; 15 g of liquid paraffin, 3 g of lanolin and 2 g of white beeswax are weighed and placed in a 100 mL beaker; the beaker is placed in a glass water bath and stirred and heated at 550 r / min for 10 min. After melting, 0.68 g of the traditional Chinese medicine ultrafine powder from Example 1 is slowly added and stirring is continued for 10 min; the mixture in the beaker is taken out and placed on a magnetic stirrer (without heating) and stirred evenly until it cools down to obtain a fine oily paste, i.e., an oily ointment.

[0062] Comparative Example 2

[0063] This comparative example provides a water-soluble ointment, which is prepared as follows: 0.6 g of sodium benzoate, 1.5 g of polyethylene glycol-4000, 2.5 g of glycerin, 1 g of 1,2-propanediol, 23 g of distilled water, and 0.68 g of the ultrafine powder from Example 1 are placed in a 100 mL beaker; the beaker is placed in a glass water bath and heated, with the water bath temperature controlled at 55 ℃, while the components in the beaker are stirred at a speed of 550 r / min. After they are dissolved and mixed evenly, the beaker is cooled to about 30 ℃ at room temperature, and 0.7 g of sodium carboxymethyl cellulose is slowly added to the beaker while stirring evenly. Then, the mixture is cooled to a viscous paste while maintaining stirring, which is the water-soluble ointment.

[0064] Comparative Example 3

[0065] This comparative example provides a W / O type cream, which is prepared as follows: 2.5 g of white beeswax, 7.5 g of liquid paraffin, 1.5 g of lanolin, 4 g of Span-80, and 2.5 g of stearic acid are added to a dry 100 mL beaker (denoted as beaker A). Beaker A is placed in a glass water bath and heated, with the water bath temperature controlled at a constant 70 °C. The mixture is stirred at a speed of 550 r / min until all components are completely melted. Then, another 100 mL dry beaker (denoted as beaker B) is taken and 5 g of glycerin, 0.4 g of Tween-80, 0.09 g of ethylparaben, 5.83 g of distilled water, and 0.68 g of the ultrafine powder from Example 1 are added to it. Beaker B is placed in a glass water bath and heated at 70 °C, and stirred for 10 min. After the components in both beakers are thoroughly mixed, the substance in beaker A is added to beaker B while stirring. The mixture is then emulsified at 70 °C and 550 r / min for 10 min. Heating is then stopped, and stirring is continued until the mixture cools to room temperature.

[0066] The ointments prepared in Example 2 and Comparative Examples 1-3 have the following appearance: Figure 1 As shown, A: Comparative Example 1; B: Comparative Example 2; C: Comparative Example 3; D: Example 2.

[0067] like Figure 1 A and Figure 1 As shown in Figure B, after adding the ultrafine powder of traditional Chinese medicine to the oily matrix and the water-soluble matrix respectively, the ointment appeared as a dark brown paste. When the water-soluble matrix was mixed with the ultrafine powder of traditional Chinese medicine, gel clumps were visible on the surface, making it difficult to stir evenly and resulting in a slightly thinner consistency.

[0068] like Figure 1 C and Figure 1 As shown in Figure D, after mixing the W / O type matrix and the O / W type matrix with the ultrafine powder of traditional Chinese medicine, the ointments both exhibited a delicate, glossy yellow paste appearance. However, the ointment in Comparative Example 3 showed poor thermal stability, exhibiting oil-water separation after being left at room temperature for one week. Despite multiple adjustments to the composition ratio of the W / O type matrix, the thermal stability of the ointment did not improve significantly. In contrast, the ointment in Example 2 maintained centrifugal stability (3000 r / min, 10 min) and thermal stability (55 ℃, 6 h), and no oil-water separation was observed after being left at room temperature for one week.

[0069] By creating a burn model, the greasy ointment in Comparative Example 1 and the O / W cream in Example 2 were administered to burned mice for one week for a preliminary drug treatment observation. The results showed that no obvious wound contraction was observed in the greasy ointment group, while obvious wound contraction was observed in the O / W cream group.

[0070] Example 3-11

[0071] Examples 3-11 provide an O / W type cream, and the raw material composition of each O / W type cream is shown in Table 1.

[0072] Table 1. Raw material ratios of the creams provided in Examples 3-11

[0073]

[0074] The preparation methods of each O / W type cream in Examples 3-11 are similar to those of the O / W type cream in Example 2, except that the emulsification temperature is different in some examples, as shown in Table 2.

[0075] Table 2. Emulsification temperature and overall score of the creams prepared in Examples 3-11

[0076]

[0077] The O / W type creams obtained in Examples 3-11 all have a uniform color and a smooth, delicate yellow appearance.

[0078] Creams are comprehensively scored based on their appearance, physical stability, spreadability, and pH value, comprising six criteria, each worth 10 points, for a total of 60 points. The scoring standards are shown in Tables 3 to 7.

[0079] ① Appearance characteristics scoring criteria

[0080] Table 3 Appearance Characteristics Scoring Criteria

[0081]

[0082] ② Physical stability scoring criteria

[0083] Physical stability reflects the overall stability of a cream, including centrifugation tests and cold and heat resistance tests.

[0084] Centrifugation test: Place 10 g of cream in a 50 mL centrifuge tube and centrifuge at 3000 r / min for 30 min. Observe whether the ointment exhibits demulsification phenomena such as oil-water separation, drug-base separation, foaming, or stratification. The ointment is scored based on its condition; the scoring criteria are shown in Table 4.

[0085] Table 4 Centrifugation Stability Scoring Criteria

[0086]

[0087] Cold resistance test: 5 g of ointment was placed in a centrifuge tube, sealed, and frozen at -20 ℃. After 24 h, the tube was removed and the appearance and color of the ointment were examined to see if the Chinese herbal ingredients and the matrix were separated. The scoring criteria are shown in Table 5.

[0088] Heat resistance test: Weigh 10 g of ointment into a centrifuge tube. To ensure that the ointment is evenly distributed at the bottom of the tube, centrifuge at 3000 r / min for 30 s, then place it in a constant temperature environment of 55 ℃. After 6 h, take it out and cool it to room temperature to observe whether the color of the ointment changes and whether the Chinese medicine components and the matrix are separated. The scoring criteria are shown in Table 5.

[0089] Table 5. Heat / Cold Stability Scoring Criteria

[0090]

[0091] ③ Scoring criteria for extensibility assessment:

[0092] The ointment's uniform and easy application is a sign of good spreadability. Take several glass plates (100 mm × 90 mm × 4 mm), and use the weight of a fixed glass plate (84 g) as pressure. Take 1 g of ointment that has been left for 24 hours and place it between the two glass plates. After 1 minute, measure the diameter of the spread ointment with a ruler. Take the average of the largest and smallest diameters as the final value. The spreadability scoring criteria are shown in Table 6.

[0093] ④ pH value evaluation and scoring criteria:

[0094] pH value reflects the stability of cream components and the quality of emulsification. Take 2.0 g of cream, accurately add 20 mL of distilled water, shake well, centrifuge at 3000 r / min for 10 min, filter, and measure the pH value of the filtrate. The pH value should ideally be close to that of body tissue fluid, between 7.1 and 7.4. The greater the deviation from the optimal range, the lower the score. The total score is 10 points, and the scoring criteria are shown in Table 7.

[0095] Table 6. Scoring Criteria for Extensibility

[0096]

[0097] Table 7 pH Value Scoring Criteria

[0098]

[0099] The comprehensive scoring results of the O / W type creams obtained in Examples 3-11 above are shown in Table 2. Generally speaking, a comprehensive score of 36 points or above is considered qualified, and 48 points or above is considered excellent. According to the comprehensive scoring results in Table 2, the creams in each example have high comprehensive scores. In comparison, the creams in Examples 4 and 10 have the best effect, with comprehensive scores above 50 points, followed by Examples 7, 8, and 11, with comprehensive scores of 48-49 points. Based on the comprehensive scores of Examples 3-11, it is inferred that when the weight of triethanolamine in the cream is 0.20-0.30g, especially 0.20-0.25g (based on a total ointment weight of 30g), and the emulsification temperature is 80-85℃, it is relatively more conducive to obtaining an ointment with better comprehensive performance.

[0100] Test case

[0101] The ointment prepared in Example 10 was applied to a C57BL / 6J mouse model of third-degree burns, with the burn area covering approximately 2% to 3% of the body surface area. The experiment was conducted in three batches. After modeling, blood was collected from the eyeballs of each batch on days 7, 14, and 21. The mice were then euthanized by cervical dislocation, and tissue samples from the burn wounds were taken for pathological sectioning to observe changes in skin morphology.

[0102] The grouping and medication details for each batch of animals are shown in Table 8. Each batch of animals was treated with medication 24 hours after the burn. As the wound gradually shrank, the dosage of medication was gradually reduced. The ointment was applied evenly to the wound with a thickness of 1 mm to 2 mm.

[0103] In this experimental case, the positive drug group was Mebo Moist Exposed Burn Ointment (MEBO). The main ingredients of Mebo Moist Exposed Burn Ointment (National Drug Approval Number Z20000004) are Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Pheretima aspergillum, and Papaver somniferum husk.

[0104] Table 8. Grouping and Medication of Each Batch of Animals

[0105]

[0106] The results of the healing rate of burn wounds in each group of mice are shown in Table 9, the time for complete scab removal in each group of mice is shown in Table 10, and the scar rate in the four groups of mice is shown in Table 11.

[0107] Table 9. Statistics on the healing rate of scalded wounds in each group of mice.

[0108]

[0109] Table 10 Time of complete scab removal in four groups of mice

[0110]

[0111] Table 11 Scarring rates in four groups of mice

[0112]

[0113] Figure 2 The appearance of wound healing in four groups of mice (model group, ointment group, MEBO group, and matrix group) from day 1 to day 21 after burns is shown. The scale bar is 3 mm long. Figure 3 The curves showing the changes in wound healing rate of four groups of mice from day 7 to day 21 are shown. There were significant differences between different time points in each group of mice. Different letters indicate significant differences, P<0.05.

[0114] Based on the statistical results in Table 4-6 and Figure 2-3 The ointment group showed faster swelling reduction in the wound and surrounding area compared to the other three groups. The ointment group and the model group exhibited better scab hardness, edge contraction tendency, and speed than the model group and the MEBO group. The duration of exudation under the scab in the ointment group was significantly shorter than that in the model group. Furthermore, the ointment group showed a wider range of hair growth on the wound surface on day 21 post-scald compared to the other three groups. Therefore, the ointment provided in this embodiment of the invention promotes scab formation speed, early healing speed, and the recovery of normal skin function, and its overall effect is superior not only to the model group and the matrix group but also to the MEBO group.

[0115] Figures 4 to 6 These are pathological sections (HE-stained) of the scald junctions in four groups of mice on days 7, 14, and 21 after drug administration. A: Model group; B: Ointment group; C: MEBO group; D: Matrix group. Figures 4 to 6 It was observed that on day 7 after drug administration, a large number of inflammatory cells infiltrated the skin, lipid membrane, and muscle layer in the junctional zone of mice in all groups. The main types of inflammatory cells were macrophages, with scattered monocytes and neutrophils. The model group had the most inflammatory cell infiltration, while the ointment group and the other two groups had less. On day 14 after drug administration, newly formed myofibroblasts were visible in the dermis of mice in all groups. Among them, the ointment group had the most orderly and concentrated arrangement of muscle fibers and the largest number of muscle bundles compared to the other three groups. On day 21 after drug administration, the skin structure repair effect of the ointment group was better than that of the other three groups. Therefore, it can be inferred that the ointment provided in this embodiment of the invention is more effective than the other three groups in promoting wound healing.

[0116] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A topical ointment for burns and scalds, characterized in that, Including ultrafine powders of matrix and traditional Chinese medicine composition; among which, The traditional Chinese medicine composition comprises the following traditional Chinese medicine components in parts by weight: 1-5 parts Coptis chinensis, 1-5 parts Scutellaria baicalensis, 1-5 parts Phellodendron chinense, 0.5-1.5 parts Pheretima aspergillum, 1-5 parts Cirsium japonicum root, and 1-5 parts Opuntia ficus-indica. The matrix is ​​an oil-in-water matrix, comprising the following components in parts by weight: 1-9 parts glycerol, 0.20-0.25 parts triethanolamine, 0.5-1.5 parts 1,2-propanediol, 0.04-0.15 parts ethylparaben, 15.5-18.5 parts water, 0.2-1.8 parts beeswax, 1-3 parts lanolin, 2-4 parts stearic acid, and 1-2 parts glyceryl monostearate; the matrix is ​​obtained by emulsifying at 80-85°C and then cooling. Based on a total weight of 30 parts for the topical ointment, the mass of the ultrafine powder is 0.60 to 0.75 parts.

2. The topical ointment according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components by weight: 2-3 parts Coptis chinensis, 2-3 parts Scutellaria baicalensis, 2-3 parts Phellodendron chinense, 0.5-1.5 parts Pheretima aspergillum, 2-3 parts Cirsium japonicum root, and 2-3 parts Opuntia ficus-indica.

3. The topical ointment according to claim 1 or 2, characterized in that, The topical ointment is a product obtained by pouring the second mixture into the first mixture, emulsifying it, and then cooling it. The first mixture is obtained by melting and mixing components including white beeswax, lanolin, stearic acid, and glyceryl monostearate in a certain proportion; the second mixture is obtained by mixing components including glycerol, triethanolamine, 1,2-propanediol, ethylparaben, and water, as well as the ultrafine powder in a certain proportion.

4. A method for preparing a topical ointment for burns and scalds, characterized in that, Includes the following steps: The first component is melted and mixed evenly to obtain the first mixture; The second component and the ultrafine powder of the traditional Chinese medicine composition are mixed evenly to obtain a second mixture; and While maintaining stirring, the second mixture is poured into the first mixture, emulsified at 80-85°C and then cooled to obtain a topical ointment. The first component comprises the following components in parts by weight: 0.2-1.8 parts white beeswax, 1-3 parts lanolin, 2-4 parts stearic acid, and 1-2 parts glyceryl monostearate; the second component comprises the following components in parts by weight: 1-9 parts glycerin, 0.20-0.25 parts triethanolamine, 0.5-1.5 parts 1,2-propanediol, 0.04-0.15 parts ethylparaben, and 15.5-18.5 parts water; the traditional Chinese medicine composition comprises the following traditional Chinese medicine components in parts by weight: 1-5 parts Coptis chinensis, 1-5 parts Scutellaria baicalensis, 1-5 parts Phellodendron chinense, 0.5-1.5 parts Pheretima aspergillum, 1-5 parts Cirsium japonicum root, and 1-5 parts Opuntia ficus-indica; based on the total weight of the external ointment being 30 parts, the mass of the ultrafine powder is 0.60-0.75 parts.

5. The preparation method according to claim 4, characterized in that, The traditional Chinese medicine composition comprises the following components by weight: 2-3 parts Coptis chinensis, 2-3 parts Scutellaria baicalensis, 2-3 parts Phellodendron chinense, 0.5-1.5 parts Pheretima aspergillum, 2-3 parts Cirsium japonicum root, and 2-3 parts Opuntia ficus-indica.

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