A traditional Chinese medicine external spray liquid for treating burns and scalds and a preparation method thereof

Abstract

The present application belongs to the field of traditional Chinese medicine external use spray, in particular to a kind of traditional Chinese medicine external use spray liquid for treating burn and scald and preparation method thereof, the traditional Chinese medicine external use spray liquid is composed of traditional Chinese medicine ethanol extract and 75% ethanol aqueous solution, the traditional Chinese medicine ethanol extract is extracted from the following weight parts of raw medicinal materials: 22-35 parts of white mulberry root, 16-30 parts of Chinese cork tree, 14-25 parts of pomegranate peel, 14-25 parts of gall, 10-22 parts of spade heron, 12-26 parts of Chinese angelica, 10-20 parts of Szechuan lovage, 12-18 parts of Baizhi and 8-16 parts of lavender; the total amount of raw medicinal materials corresponding to 1000mL of traditional Chinese medicine external use spray liquid is 156-179g. Thus, the problems of single formula composition, insufficient cooperation of various drug components and unstable nursing effect of existing burn and scald external use traditional Chinese medicine are solved, and the consistency of extraction degree of different batches of medicinal liquid is improved, thus solving the problems of insufficient extraction of effective components of medicinal materials, more residues of medicinal liquid and fluctuation of medicinal liquid component content in existing single extraction process.

Description

Technical Field

[0001] This invention belongs to the field of external sprays for traditional Chinese medicine, and in particular relates to an external spray for treating burns and scalds and its preparation method. Background Technology

[0002] Existing topical medications for burns and scalds are usually in the form of ointments, tinctures, or sprays. They use traditional Chinese medicine ingredients with astringent, heat-clearing, antibacterial, and blood-activating effects to care for burn and scald wounds. Among them, sprays are used because they are convenient to use and can reduce direct contact with the wound.

[0003] The extraction and purification processes of existing traditional Chinese medicine burn sprays are relatively simple, which can easily lead to insufficient leaching of effective ingredients, a large number of impurities in the liquid, and precipitation during storage. As a result, the composition and stability of different batches of liquid are difficult to maintain, leading to unstable burn wound care effects. Summary of the Invention

[0004] The purpose of this invention is to address the problem that the existing extraction and purification processes of traditional Chinese medicine burn sprays, as mentioned in the background section, are relatively simple, which easily leads to insufficient leaching of effective ingredients, a large number of impurities in the liquid, and precipitation during storage. This results in inconsistent composition and stability of different batches of liquid, and unstable burn wound care effects.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a traditional Chinese medicine external spray for treating burns, wherein the traditional Chinese medicine external spray is composed of a traditional Chinese medicine ethanol extract and a 75% (v / v) ethanol aqueous solution, wherein the traditional Chinese medicine ethanol extract is obtained by extracting the following raw materials in parts by weight: 22-35 parts of Sanguisorba officinalis, 16-30 parts of Phellodendron chinense, 14-25 parts of Punica granatum peel, 14-25 parts of Galla chinensis, 10-22 parts of Portulaca oleracea, 12-26 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 12-18 parts of Angelica dahurica, and 8-16 parts of Lavender; the total amount of the raw materials corresponding to each 1000 mL of the traditional Chinese medicine external spray is 156-179 g.

[0006] Specifically, the raw materials include 30 parts of Sanguisorba officinalis, 25 parts of Phellodendron chinense, 20 parts of pomegranate peel, 20 parts of gallnut, 18 parts of purslane, 18 parts of Angelica sinensis, 12 parts of Ligusticum chuanxiong, 15 parts of Angelica dahurica, and 10 parts of lavender. The total amount of the raw materials corresponding to each 1000 mL of the traditional Chinese medicine external spray is 168 g.

[0007] Specifically, the raw materials include 35 parts of Sanguisorba officinalis, 30 parts of Phellodendron chinense, 25 parts of pomegranate peel, 25 parts of gallnut, 22 parts of purslane, 12 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 12 parts of Angelica dahurica and 8 parts of lavender. The total amount of the raw materials corresponding to each 1000 mL of the traditional Chinese medicine external spray is 179 g.

[0008] Specifically, the raw materials include 22 parts of Sanguisorba officinalis, 16 parts of Phellodendron chinense, 14 parts of pomegranate peel, 14 parts of gallnut, 10 parts of purslane, 26 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 18 parts of Angelica dahurica, and 16 parts of lavender. The total amount of the raw materials corresponding to each 1000 mL of the traditional Chinese medicine external spray is 156 g.

[0009] A method for preparing a traditional Chinese medicine external spray for treating burns includes the following steps: S1. Weigh out 22-35 parts of Sanguisorba officinalis, 16-30 parts of Phellodendron chinense, 14-25 parts of pomegranate peel, 14-25 parts of gallnut, 10-22 parts of purslane, 12-26 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 12-18 parts of Angelica dahurica, and 8-16 parts of lavender according to the weight. Remove impurities, wash and air-dry them separately, then grind them into coarse powder. Mix the coarse powders of each raw material. S2. Add a 75% (v / v) aqueous ethanol solution to the mixed raw material powder, and perform a first impregnation under sealed and light-proof conditions. Separate the solid and liquid to obtain a first extract and a residue. Add a 75% (v / v) aqueous ethanol solution to the residue for a second impregnation, and separate the solid and liquid to obtain a second extract. Combine the first extract and the second extract. S3. The combined extracts are subjected to coarse filtration and microporous membrane fine filtration in sequence. The filtrate after fine filtration is allowed to settle under light-proof and low-temperature conditions. The supernatant after settling is collected and the ethanol volume fraction of the supernatant is adjusted to 75%. S4. The supernatant after adjusting the ethanol volume fraction is sterilized and filtered, and then filled into a spray container in a clean environment to obtain the traditional Chinese medicine external spray.

[0010] Specifically, in step S2, the mass of the 75% ethanol aqueous solution added for the first impregnation is 6 to 8 times the total mass of the raw material. The first impregnation lasts for 10 to 15 days at room temperature. The second impregnation uses the same volume fraction of ethanol aqueous solution as the first impregnation.

[0011] Specifically, in step S3, the coarse filtration adopts plate and frame filtration, the microporous membrane fine filtration adopts a microporous filter membrane with a pore size of 0.45μm, the filtrate after fine filtration is allowed to settle in the dark at 5-15℃, and the supernatant is obtained by siphon.

[0012] Specifically, in step S4, the sterilization filtration uses a sterilization filter membrane with a pore size of 0.22 μm, and the sterilized filtered medicine is sealed and filled into a spray container in a clean environment.

[0013] Compared with existing technologies, the advantages of this traditional Chinese medicine external spray for treating burns and scalds and its preparation method are as follows: 1. This invention achieves a synergistic combination of astringent, heat-clearing, blood-activating, and aromatic volatile drug components through a compound formulation system composed of Sanguisorba officinalis, Phellodendron chinense, pomegranate peel, gallnut, purslane, Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and lavender. This solves the problems of existing external Chinese medicine formulas for burns and scalds having a single composition, insufficient combination of various drug components, and unstable nursing effects.

[0014] 2. This invention achieves full extraction of tannins, alkaloids, flavonoids, volatile oils and fat-soluble components from raw materials by performing a two-stage ethanol extraction process, which involves a first soaking of mixed medicinal materials and a second soaking of the residue. It also improves the consistency of extraction degree between different batches of medicinal liquid, thereby solving the problems of insufficient extraction of effective components of medicinal materials, excessive residue, and fluctuation of medicinal liquid composition in existing single-stage extraction processes.

[0015] 3. This invention achieves the step-by-step removal of medicinal residue particles, fine suspended matter, unstable precipitates, and microorganisms through a graded purification and filling process consisting of plate and frame coarse filtration, microporous membrane fine filtration, low-temperature static sedimentation, and terminal sterilization filtration. This results in a clear medicinal liquid suitable for spray output and sealed storage, thereby solving the problems of existing Chinese medicine external spray liquids having many impurities, being prone to turbidity and precipitation during storage, and having poor product quality stability. Attached Figure Description

[0016] Figure 1 This is a flowchart illustrating a method for preparing a traditional Chinese medicine external spray for treating burns provided by the present invention. Detailed Implementation

[0017] The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0018] like Figure 1 As shown, this application proposes a traditional Chinese medicine external spray for treating burns, which may include a traditional Chinese medicine external spray composed of a traditional Chinese medicine ethanol extract and a 75% (v / v) ethanol aqueous solution. The traditional Chinese medicine ethanol extract is obtained by extracting the following raw materials in parts by weight: 22-35 parts of Sanguisorba officinalis, 16-30 parts of Phellodendron chinense, 14-25 parts of Punica granatum peel, 14-25 parts of Galla chinensis, 10-22 parts of Portulaca oleracea, 12-26 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 12-18 parts of Angelica dahurica, and 8-16 parts of Lavender; the total amount of raw materials corresponding to each 1000 mL of traditional Chinese medicine external spray is 156-179 g.

[0019] It should be noted that the herbal external spray described in this embodiment uses Sanguisorba officinalis, Phellodendron chinense, pomegranate peel, gallnut, purslane, Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and lavender as raw materials, and uses an ethanol-water solution as the extraction medium and liquid carrier. Among them, Sanguisorba officinalis, pomegranate peel, and gallnut constitute an astringent drug combination; Phellodendron chinense and purslane constitute a heat-clearing drug combination; Angelica sinensis and Ligusticum chuanxiong constitute a blood-activating drug combination; and Angelica dahurica and lavender constitute an aromatic volatile drug combination. All kinds of raw materials are combined in a coordinated proportion to form a compound herbal extraction system.

[0020] Specifically, after the ethanol-water solution comes into contact with each raw material, tannins, alkaloids, flavonoids, volatile oils, and fat-soluble components in the raw materials are co-extracted, ensuring that the extracted components from different raw materials are evenly dispersed in the spray solution. When used as a spray, the solution covers the surface of the skin to be treated, and the synergistic effect between the components creates astringent, cleansing, and skin-restoring care effects. By limiting the composition and relative dosage of the raw materials, a well-defined traditional Chinese medicine ethanol extract is formed, reducing the differences in the composition of the solution caused by inconsistent selection of herbs and proportions at the formulation level. This solves the problems of unstable composition and inconsistent care effects between different batches in existing traditional Chinese medicine burn sprays.

[0021] Furthermore, such as Figure 1 As shown, the raw materials include 30 parts of Sanguisorba officinalis, 25 parts of Phellodendron chinense, 20 parts of pomegranate peel, 20 parts of gallnut, 18 parts of purslane, 18 parts of Angelica sinensis, 12 parts of Ligusticum chuanxiong, 15 parts of Angelica dahurica, and 10 parts of lavender. The total amount of raw materials corresponding to each 1000mL of herbal external spray is 168g.

[0022] It should be noted that the active pharmaceutical ingredient (API) formulation described in this embodiment is a relatively balanced combination of various drug components. Sanguisorba officinalis, Phellodendron chinense, pomegranate peel, and gallnut form the main astringent and heat-clearing drug base, with Portulaca oleracea complementing it. Angelica sinensis and Ligusticum chuanxiong are used to supplement blood-activating components, while Angelica dahurica and lavender are used to supplement volatile and aromatic components. After mixing and extraction, the APIs together form a relatively balanced compound Chinese medicine ethanol extract.

[0023] Specifically, the ethanol-extractable components from Sanguisorba officinalis, pomegranate peel, and gallnut, along with related components from Phellodendron chinense and Portulaca oleracea, are extracted into the medicinal liquid. Simultaneously, the fat-soluble or volatile components from Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and lavender are extracted, resulting in a spray containing extracts from multiple traditional Chinese medicines. By using a standardized formula for weighing and preparing each raw material, each batch of spray has a relatively uniform raw material composition, solving the problem of fluctuating quality and efficacy caused by arbitrary drug compatibility and imbalanced proportions of different functional components in existing sprays.

[0024] Furthermore, such as Figure 1As shown, the raw materials include 35 parts of Sanguisorba officinalis, 30 parts of Phellodendron chinense, 25 parts of pomegranate peel, 25 parts of Galla chinensis, 22 parts of Portulaca oleracea, 12 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 12 parts of Angelica dahurica and 8 parts of Lavender. The total amount of raw materials corresponding to each 1000mL of Chinese herbal external spray is 179g.

[0025] It should be noted that the active pharmaceutical ingredient formulation described in this embodiment increases the relative proportions of Sanguisorba officinalis, Phellodendron chinense, Punica granatum peel, Galla chinensis, and Portulaca oleracea in the compound, while correspondingly reducing the relative proportions of Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and Lavender, resulting in a higher proportion of astringent and heat-clearing drug extracts in the obtained ethanol extract of traditional Chinese medicine. This formulation still retains blood-activating and aromatic volatile drugs to maintain the synergistic relationship between various components.

[0026] Specifically, after ethanol extraction, the tannins in Sanguisorba officinalis, pomegranate peel, and gallnut, along with related components in Phellodendron chinense and Portulaca oleracea, enter the extract. The extracts from Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and lavender are dispersed as co-processing components in the liquid, creating a compound system primarily composed of astringent and heat-clearing extracts. By clearly defining the raw material composition of this type of formula, it is possible to avoid arbitrarily adding or removing medicinal ingredients during production, which could lead to an imbalance in the content of the main components. This solves the problems of lacking a unified standard for the composition of the liquid and significant batch-to-batch variations in extracted components in existing technologies.

[0027] Furthermore, such as Figure 1 As shown, the raw materials include 22 parts of Sanguisorba officinalis, 16 parts of Phellodendron chinense, 14 parts of pomegranate peel, 14 parts of gallnut, 10 parts of purslane, 26 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 18 parts of Angelica dahurica and 16 parts of lavender. The total amount of raw materials corresponding to each 1000mL of Chinese herbal external spray is 156g.

[0028] It should be noted that the active pharmaceutical ingredient (API) formulation described in this embodiment increases the relative proportions of Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and Lavender in the compound, while retaining Sanguisorba officinalis, Phellodendron chinense, Punica granatum peel, Galla chinensis, and Portulaca oleracea as basic components. This results in a corresponding increase in the proportion of blood-activating and aromatic volatile drug extracts in the obtained ethanol extract of traditional Chinese medicine. All APIs are still formulated according to a fixed composition to form a compound solution suitable for skin recovery and care.

[0029] Specifically, the fat-soluble components of Angelica sinensis and Ligusticum chuanxiong, as well as the volatile components of Angelica dahurica and Lavender, are extracted with ethanol and then incorporated into the medicinal liquid. These components, along with extracts from Sanguisorba officinalis, Phellodendron chinense, Punica granatum peel, Galla chinensis, and Portulaca oleracea, form a complex extraction system, enabling the spray to be used for external skin care during wound recovery. By defining the relative relationships of the raw materials in the recovery care formula, the resulting medicinal liquid has a clear and reproducible composition, addressing the problems of inconsistent product quality caused by the lack of standardization in existing external medicinal liquid formulas for the recovery period and the inconsistent dosage of blood-activating and aromatic components.

[0030] Furthermore, such as Figure 1 The procedure includes the following steps: S1. Weigh out 22-35 parts of Sanguisorba officinalis, 16-30 parts of Phellodendron chinense, 14-25 parts of pomegranate peel, 14-25 parts of Gallnut, 10-22 parts of Portulaca oleracea, 12-26 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 12-18 parts of Angelica dahurica, and 8-16 parts of Lavender according to their respective weights. After removing impurities, washing, and air-drying, grind them into coarse powder and mix the coarse powders of each raw material; S2. Add a 75% (v / v) ethanol aqueous solution to the mixed coarse powder of the raw materials, and carry out the first impregnation under sealed and light-proof conditions. Separate the solid and liquid to obtain the first impregnation solution. S1. Extract and residue; add 75% ethanol aqueous solution to the residue for a second soaking, separate the solid and liquid to obtain the second extract, and combine the first and second extracts; S2. subject the combined extract to coarse filtration and microporous membrane fine filtration in sequence, let the filtrate after fine filtration stand for sedimentation under light-proof and low-temperature conditions, take the supernatant after sedimentation and adjust the ethanol volume fraction of the supernatant to 75%; S3. subject the supernatant after adjusting the ethanol volume fraction to sterile filtration, and fill it into spray containers in a clean environment to obtain the traditional Chinese medicine external spray.

[0031] It should be noted that the preparation method described in this embodiment is carried out sequentially according to the following steps: herbal pretreatment step S1, secondary impregnation and extraction step S2, filtration, sedimentation and purification step S3, and sterilization and filling step S4. Herbal pretreatment step S1 is used to standardize the cleanliness and particle state of each raw material; secondary impregnation and extraction step S2 is used to ensure that the raw materials are in full contact with the ethanol aqueous solution; filtration, sedimentation and purification step S3 is used to remove the residue, suspended solids and sediments in the liquid step by step; sterilization and filling step S4 is used to perform final treatment on the liquid after purification and form a spray product.

[0032] Specifically, in the herbal pretreatment step S1, the raw materials are processed into a mixed coarse powder to increase the contact area between the raw materials and the extraction medium. In the secondary impregnation extraction step S2, the mixed coarse powder is first impregnated, and then the separated residue is impregnated a second time, and the two extracts are combined. In the filtration, sedimentation, and purification step S3, the combined extract is subjected to graded filtration and low-temperature sedimentation to obtain a clear supernatant. Finally, in the sterilization and filling step S4, sterilization and sealing are completed. By forming a continuous and standardized extraction, purification, and filling process, the problems of insufficient extraction, impurity residue, and easy precipitation during storage of existing Chinese medicine sprays, which lead to unstable quality of the liquid, are solved.

[0033] Furthermore, such as Figure 1As shown, in step S2, the mass of the 75% ethanol aqueous solution added for the first impregnation is 6 to 8 times the total mass of the raw material. The first impregnation lasts for 10 to 15 days at room temperature. The second impregnation uses the same volume fraction of ethanol aqueous solution as the first impregnation.

[0034] It should be noted that in this embodiment, the secondary impregnation extraction step S2 uses the same type of ethanol-water solution to extract the mixed raw drug powder and the residue after the first impregnation, respectively. After the first impregnation is completed, the first extract is promptly separated from the residue, and new extraction medium is added to the residue so that the components in the residue that were not extracted in the first impregnation can continue to enter the second extract. The two extracts are then combined and proceeded to the subsequent purification process.

[0035] Specifically, during the first impregnation, the ethanol-water solution penetrates the crude drug powder and dissolves the ethanol-soluble components. After solid-liquid separation, some components that have not fully diffused into the first extract remain inside the residue. The second impregnation, by re-establishing the concentration difference between the drug powder and the extraction medium, allows the remaining components to migrate further into the extraction medium. By impregnating twice and combining the extracts, the loss of effective extractable components caused by the discharge of the residue is reduced, solving the problems of insufficient extraction in a single impregnation and large fluctuations in the extraction degree between different batches.

[0036] Furthermore, such as Figure 1 As shown, in step S3, coarse filtration is performed using plate and frame filtration, and fine filtration using a microporous membrane with a pore size of 0.45 μm. The filtrate after fine filtration is allowed to settle in the dark at 5–15 °C, and the supernatant is obtained by siphon.

[0037] It should be noted that the filtration, sedimentation, and purification step S3 described in this embodiment includes plate and frame coarse filtration, microporous membrane fine filtration, low-temperature settling, and supernatant separation. The plate and frame coarse filtration is performed before the microporous membrane fine filtration to retain medicinal fiber, residue particles, and larger suspended solids, thereby reducing the filtration load on the subsequent microporous membrane. The filtrate after fine filtration is transferred to a light-proof container for low-temperature settling, allowing fine particles not completely retained by the membrane and insoluble components precipitated under low-temperature conditions to gradually settle.

[0038] Specifically, the combined extract is first filtered through a plate and frame filter to remove larger impurities, and then filtered through a microporous membrane to retain fine suspended solids, achieving a high degree of clarity in the filtrate. Subsequently, low-temperature settling allows residual fine impurities to aggregate and settle to the bottom of the container. The supernatant is then obtained from the top of the sediment layer by siphoning, avoiding disturbance of the bottom sediment during the extraction process. This staged purification method, involving coarse filtration, fine filtration, and low-temperature sedimentation, solves the problem of fine impurities remaining and re-precipitation after the drug solution has been left to stand due to the use of only one ordinary filtration in existing processes.

[0039] Furthermore, such as Figure 1 As shown, in step S4, the sterilization filtration uses a sterilization filter membrane with a pore size of 0.22μm, and the sterilized filtered drug solution is sealed and filled into a spray container in a clean environment.

[0040] It should be noted that the sterilization filling step S4 described in this embodiment is performed after the impregnation extraction, graded filtration, low-temperature sedimentation, and ethanol concentration adjustment are completed. The pipelines, storage containers, and spray containers that come into contact with the sterilization filter membrane and the drug solution are cleaned before use. The sterilized drug solution directly enters the clean filling area and is dispensed and sealed under conditions that minimize contact with outside air and the operating environment, thus preventing the purified drug solution from being recontaminated during the filling process.

[0041] Specifically, when the supernatant passes through the sterile filter membrane, microorganisms and residual fine particles in the medicinal solution are trapped by the membrane. The filtered, clarified medicinal solution is directly delivered to the spray container and sealed, ensuring that the extracted and purified medicinal solution is in a relatively closed storage environment. By setting up sterile filtration and clean, sealed filling at the end of the preparation process, the turbidity, precipitation, and quality changes of the medicinal solution during storage due to microbial contamination or the entry of external impurities are reduced. This solves the problems of insufficient terminal treatment and difficulty in ensuring product storage stability in existing traditional Chinese medicine spray solutions.

[0042] Example 1 This embodiment provides a traditional Chinese medicine external spray for treating burns and scalds. The raw materials are weighed as follows: 30g of Sanguisorba officinalis, 25g of Phellodendron chinense, 20g of pomegranate peel, 20g of Galla chinensis, 18g of Portulaca oleracea, 18g of Angelica sinensis, 12g of Ligusticum chuanxiong, 15g of Angelica dahurica and 10g of Lavender, with a total weight of 168g.

[0043] The traditional Chinese medicine external spray solution is prepared according to the following steps: S1. Pretreatment of medicinal materials. The following raw materials were cleaned and purified: Sanguisorba officinalis, Phellodendron chinense, pomegranate peel, gallnut, purslane, Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica and lavender. The cleaned raw materials were air-dried and then crushed into coarse powder. The coarse powders were then mixed evenly to obtain a mixed medicinal powder.

[0044] S2. Secondary immersion extraction. The mixed medicinal powder is placed in a sealed extraction vessel, and a 75% (v / v) ethanol aqueous solution, seven times the total weight of the mixed medicinal powder, is added to immerse the powder in the ethanol aqueous solution. The mixture is immersed for 12 days under normal temperature, sealed, and light-protected conditions. After the first immersion, solid-liquid separation is performed to obtain the first extract and the residue. A second immersion is performed by adding a 75% (v / v) ethanol aqueous solution to the residue. After the second immersion, solid-liquid separation is performed to obtain the second extract. The two extracts are then combined. Example 1, using a 7-fold ethanol aqueous solution and a 12-day immersion period, is an intermediate implementation method within the scope defined by the claims.

[0045] S3. Filtration and purification. The combined extracts were first coarsely filtered through a plate and frame filter, and then finely filtered through a microporous membrane with a pore size of 0.45 μm. The finely filtered filtrate was placed at 10°C in the dark to settle. After settling, the supernatant was obtained by siphoning, and the ethanol concentration was calibrated and adjusted to 1000 mL using a 75% (v / v) ethanol aqueous solution.

[0046] S4. Sterilization Filling. The calibrated medicinal solution is filtered through a sterile filter membrane with a pore size of 0.22 μm for terminal sterilization. The sterile filtered medicinal solution is then sealed and filled into a spray container in a clean environment to obtain a traditional Chinese medicine external spray for treating burns and scalds. The 10°C sedimentation, volume adjustment to 1000 mL, and 0.22 μm terminal sterilization in the original embodiment have been specifically described.

[0047] This embodiment uses a relatively balanced ratio of various raw materials to form a compound Chinese medicine ethanol extraction system, which can be used as a relatively balanced specific formula in this invention.

[0048] To illustrate the application of the traditional Chinese medicine external preparation of this invention in the care of large-area burn wounds, relevant case data were observed. One patient, a 47-year-old male, suffered burns to multiple areas including the head, face, neck, and both upper limbs due to a biogas explosion, with burns covering approximately 49% of his body surface area. Upon admission, the wounds exhibited significant redness, swelling, blisters, ruptured oozing, and partial skin peeling, accompanied by significant pain. During treatment, external application of traditional Chinese medicine was combined with routine symptomatic treatment. The wounds gradually dried, scabbed over, and fell off. Pain and limited mobility gradually improved. By discharge, the wounds had healed, with no residual scabs or obvious scars, only a color difference with the surrounding skin. The case data recorded that he received treatment including topical application of traditional Chinese medicine, anti-inflammatory medication, and vitamin supplementation. By discharge, 49% of the burn area had healed.

[0049] Another patient, a 38-year-old male, suffered burns to his face, neck, and both upper limbs due to an electrical short circuit explosion. He was diagnosed with deep second-degree burns, covering approximately 41% of his body surface area. Upon admission, the wounds were red and swollen, with ruptured blisters and significant exudate and pain. After treatment with topical traditional Chinese medicine and routine symptomatic therapy, the facial and neck wounds gradually healed, the redness and swelling and blisters on his upper limbs gradually disappeared, the scabs gradually fell off, and the pain significantly decreased. By the time of discharge, the burn wounds had completely healed, with no residual scabs or obvious scarring.

[0050] Example 2 This embodiment provides another traditional Chinese medicine external spray for treating burns and scalds. The raw materials are weighed as follows: 35g of Sanguisorba officinalis, 30g of Phellodendron chinense, 25g of pomegranate peel, 25g of Galla chinensis, 22g of Portulaca oleracea, 12g of Angelica sinensis, 10g of Ligusticum chuanxiong, 12g of Angelica dahurica and 8g of Lavender, with a total weight of 179g.

[0051] First, the above-mentioned raw materials are subjected to impurity removal, cleaning, and air-drying. The air-dried raw materials are then crushed into coarse powder and mixed evenly.

[0052] Subsequently, the mixed powder was placed in a sealed extraction tank, and 6 times the total weight of the mixed powder was added with a 75% ethanol aqueous solution. The first impregnation was carried out under normal temperature, sealed and light-proof conditions for 10 days. After the first impregnation, solid-liquid separation was performed, and the first extract was collected. A 75% ethanol aqueous solution was added to the obtained residue for a second impregnation. After the second impregnation, solid-liquid separation was performed, and the two extracts were combined.

[0053] The combined extracts were subjected to coarse plate and frame filtration and fine filtration through a 0.45 μm microporous membrane. The filtrate after fine filtration was then allowed to settle at 5°C in the dark. After settling, the supernatant was obtained by siphoning. The ethanol concentration was calibrated and the volume was adjusted using a 75% (v / v) ethanol aqueous solution to obtain a total volume of 1000 mL. Finally, the solution was subjected to terminal sterilization filtration through a 0.22 μm sterile filter membrane and sealed and filled into spray containers in a clean environment to obtain a traditional Chinese medicine external spray. The 6-fold dosage, 10-day immersion, and 5°C settling in this embodiment correspond to the lower limit of the scope defined in the claims.

[0054] Compared with Example 1, this example increases the relative amounts of Sanguisorba officinalis, Phellodendron chinense, pomegranate peel, gallnut, and purslane, and correspondingly reduces the relative amounts of Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica, and lavender. This results in a relatively higher proportion of astringent and heat-clearing raw materials in the obtained ethanol extract of traditional Chinese medicine, which can be used as a specific formula for a stage of burn wound with significant exudation.

[0055] As a case study related to the application of the traditional Chinese medicine external preparation of this invention in the care of burn wounds, a 40-year-old female patient suffered burns to her face, ears, neck, chest, both upper and lower limbs due to a gas leak and subsequent explosion. She was diagnosed with deep second-degree burns, covering approximately 43% of her total body surface area. Upon admission, the wounds showed extensive redness and swelling, ruptured blisters, significant exudation, and marked pain. After treatment with the traditional Chinese medicine external preparation combined with conventional therapy, the redness and swelling gradually subsided, scabs formed and gradually fell off, and the pain gradually disappeared. By the time of discharge, the wounds had healed, with no significant limitation of movement, and no residual scabs or obvious scarring were observed.

[0056] Another patient, a 57-year-old male, was admitted to the hospital seven days after suffering a scald to his right lower limb from boiling water. He was diagnosed with a deep second-degree burn, covering approximately 27% of his body surface area. Before admission, the burn site already showed significant infection, manifested as redness, swelling, ruptured blisters, oozing, and pain, accompanied by limited movement of the right lower limb. After admission, he received topical treatment with traditional Chinese medicine combined with anti-inflammatory and other routine treatments. The wound exudate and related symptoms gradually improved. By the time of discharge, approximately 25% of the burn area had healed, with only about 2% still requiring continued care due to scab formation. No obvious scarring was observed in the healed areas.

[0057] Example 3 This embodiment provides another traditional Chinese medicine external spray for treating burns and scalds. The raw materials are weighed as follows: 22g of Sanguisorba officinalis, 16g of Phellodendron chinense, 14g of pomegranate peel, 14g of gallnut, 10g of purslane, 26g of Angelica sinensis, 20g of Ligusticum chuanxiong, 18g of Angelica dahurica and 16g of lavender, with a total weight of 156g.

[0058] The above-mentioned raw materials were cleaned and purified, and the cleaned raw materials were air-dried and crushed into coarse powder. The coarse powders of the raw materials were then mixed evenly.

[0059] Add the mixed medicinal powder to a sealed extraction vessel, and add 8 times the total weight of the mixed medicinal powder with a volume fraction of 75% ethanol aqueous solution. Soak for 15 days under normal temperature, sealed and light-proof conditions. After the first soaking is completed, separate the first extract from the residue, and then add a volume fraction of 75% ethanol aqueous solution to the residue for a second soaking. Collect the second extract and combine it with the first extract.

[0060] The combined extract was first coarsely filtered through a plate and frame filter, then finely filtered through a microporous membrane with a pore size of 0.45 μm. The finely filtered filtrate was then allowed to settle at 15°C in the dark. After settling, the supernatant was obtained by siphoning, and the ethanol concentration was calibrated and the volume was adjusted using a 75% (v / v) ethanol aqueous solution to obtain a total volume of 1000 mL. Subsequently, the obtained solution was subjected to terminal sterilization filtration through a sterile membrane with a pore size of 0.22 μm, and then sealed and filled into spray containers in a clean environment to obtain a traditional Chinese medicine external spray. This embodiment uses 8 times the amount of ethanol, 15 days of immersion, and 15°C settling, corresponding to the other end of the relevant process parameters in the claims.

[0061] Compared with Example 1, this example increases the relative amounts of Angelica sinensis, Ligusticum chuanxiong, Angelica dahurica and lavender in the raw materials, and correspondingly reduces the relative amounts of Sanguisorba officinalis, Phellodendron chinense, Punica granatum peel, Galla chinensis and Portulaca oleracea, so that the proportion of blood-activating and aromatic volatile raw materials in the obtained Chinese herbal ethanol extract is relatively increased, which can be used as a specific formula for the recovery and care stage of burn wounds.

[0062] As a relevant case, a 1-year-6-month-old girl suffered deep second-degree burns to her left upper limb, chest, abdomen, and both lower limbs due to steam and water from a pressure cooker. The burns covered approximately 27% of her total body surface area. Upon admission, she presented with significant redness, swelling, blisters, ruptured oozing fluid, and pain. The case file indicated a diagnosis of 27% deep second-degree burns. After topical application of traditional Chinese medicine combined with conventional treatment, the redness and blisters gradually subsided, scabs formed on the burned areas and gradually fell off, and by discharge, approximately 25% of the burn area had healed, with only about 2% still bearing scabs. No obvious scarring was observed in the healed areas.

[0063] Another patient, a boy aged 1 year and 4 months, suffered burns to his back, waist, ribs, buttocks, perineum, and both lower limbs after falling into a container of boiling water. He was diagnosed with deep second-degree burns, covering approximately 47% of his body surface area. Upon admission, the wounds were extensively red and swollen, with ruptured blisters, significant exudation, and marked pain. After treatment with topical Chinese medicine and conventional therapy, the redness and blisters gradually subsided, scabs formed and gradually fell off, and the wound area continued to shrink. By the time of discharge, approximately 45% of the burn area had healed, with only about 2% still showing scabs. No obvious scarring was observed in the healed areas.

[0064] Example 4 This embodiment illustrates the specific combination of secondary impregnation, graded filtration, low-temperature sedimentation, and terminal sterilization filtration in the preparation process of this invention.

[0065] According to the formula in Example 1, 168g of raw materials were weighed. After impurity removal, washing, air drying, pulverizing, and mixing, the resulting mixed powder was placed in a sealed extraction tank, and a 75% (v / v) ethanol aqueous solution was added for the first impregnation. After the first impregnation, the first extract and the residue were separated into solid and liquid components. Then, a 75% (v / v) ethanol aqueous solution was added to the residue for a second impregnation, allowing the ethanol-soluble components remaining in the residue after the first impregnation to further enter the second extract.

[0066] The two extracts were combined and first subjected to plate and frame filtration to remove medicinal fiber, residue particles, and larger suspended solids. Then, a microporous membrane with a pore size of 0.45 μm was used for fine filtration to reduce fine suspended solids in the solution. The filtrate was then allowed to settle under low temperature and dark conditions, allowing any remaining fine insoluble components and unstable components precipitated at low temperature to settle to the bottom of the container. The supernatant was then obtained by siphoning to minimize disturbance to the bottom sediment during the extraction process.

[0067] After the obtained supernatant was calibrated for ethanol concentration, it was then filtered through a sterile filter membrane with a pore size of 0.22 μm for terminal sterilization, and then directly sealed and filled into spray containers in a clean environment.

[0068] This embodiment employs a continuous extraction process through secondary impregnation, a graded purification process through plate and frame coarse filtration, microporous membrane fine filtration, and low-temperature settling, and incorporates terminal sterilization filtration before filling. This seamlessly integrates raw material extraction, impurity removal, liquid clarification, and sterilization filling, thereby reducing drug residue particles, fine suspended matter, and unstable precipitates in the liquid, resulting in a traditional Chinese medicine external spray suitable for spray output and sealed storage. This process arrangement is consistent with the technical content of Example 4 in the original specification.

[0069] It should be noted that the above embodiments and case observations are only used to illustrate the composition, preparation method and application of the topical Chinese medicine preparation of the present invention in the care of burn wounds, and are not intended to limit the scope of protection of the present invention.

[0070] In summary, the working principle of this traditional Chinese medicine external spray for treating burns and scalds and its preparation method is as follows: In the pretreatment step S1, the following raw materials are first processed: *Sanguisorba officinalis*, *Phellodendron chinense*, pomegranate peel, *Galium affine*, *Portulaca oleracea*, *Angelica sinensis*, *Ligusticum chuanxiong*, *Angelica dahurica*, and lavender are cleaned, washed, air-dried, pulverized, and mixed to form a uniformly mixed coarse powder. Then, in the secondary impregnation and extraction step S2, the mixed coarse powder is first impregnated with an ethanol-water solution, and the separated residue is impregnated a second time. The extracts obtained from the two impregnations are combined, ensuring that the ethanol-soluble components of each raw material are fully incorporated into the extract. Finally, in the filtration, sedimentation, and purification step S3, the combined extract is sequentially subjected to coarse filtration, microporous membrane fine filtration, and low-temperature, light-protected sedimentation. The supernatant is obtained by siphoning and the ethanol concentration is adjusted to remove medicinal residues, suspended particles, and unstable precipitates step by step. Finally, in the sterilization and filling step S4, the supernatant is sterilized and filtered, and then sealed and filled into spray containers in a clean environment to obtain a traditional Chinese medicine external spray. When used, the spray is evenly sprayed onto the area to be treated, so that the compound extracts of the nine raw materials work together on the skin surface. This preparation method, which combines standardized formula, secondary immersion extraction, graded filtration, low-temperature sedimentation, and terminal sterilization, solves the problems of insufficient extraction of effective ingredients, high impurity content, easy precipitation during storage, and difficulty in maintaining stable quality and care effect between different batches of products in existing traditional Chinese medicine burn sprays.

[0071] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine external spray for treating burns and scalds, characterized in that, The herbal external spray is composed of an ethanol extract of traditional Chinese medicine and a 75% (v / v) aqueous ethanol solution. The ethanol extract of traditional Chinese medicine is obtained by extracting the following raw materials in parts by weight: 22-35 parts of Sanguisorba officinalis, 16-30 parts of Phellodendron chinense, 14-25 parts of Punica granatum peel, 14-25 parts of Galla chinensis, 10-22 parts of Portulaca oleracea, 12-26 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 12-18 parts of Angelica dahurica, and 8-16 parts of Lavender. The total amount of the raw materials corresponding to each 1000 mL of the herbal external spray is 156-179 g.

2. The traditional Chinese medicine external spray for treating burns according to claim 1, characterized in that, The raw materials include 30 parts of Sanguisorba officinalis, 25 parts of Phellodendron chinense, 20 parts of pomegranate peel, 20 parts of gallnut, 18 parts of purslane, 18 parts of Angelica sinensis, 12 parts of Ligusticum chuanxiong, 15 parts of Angelica dahurica, and 10 parts of lavender. The total amount of the raw materials corresponding to each 1000 mL of the herbal external spray is 168 g.

3. The traditional Chinese medicine external spray for treating burns and scalds according to claim 1, characterized in that, The raw materials include 35 parts of Sanguisorba officinalis, 30 parts of Phellodendron chinense, 25 parts of pomegranate peel, 25 parts of gallnut, 22 parts of purslane, 12 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 12 parts of Angelica dahurica and 8 parts of lavender. The total amount of the raw materials corresponding to each 1000 mL of the traditional Chinese medicine external spray is 179 g.

4. The traditional Chinese medicine external spray for treating burns according to claim 1, characterized in that, The raw materials include 22 parts of Sanguisorba officinalis, 16 parts of Phellodendron chinense, 14 parts of pomegranate peel, 14 parts of gallnut, 10 parts of purslane, 26 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 18 parts of Angelica dahurica and 16 parts of lavender. The total amount of the raw materials corresponding to each 1000mL of the traditional Chinese medicine external spray is 156g.

5. A method for preparing a traditional Chinese medicine external spray for treating burns, characterized in that, Includes the following steps: S1. Weigh out 22-35 parts of Sanguisorba officinalis, 16-30 parts of Phellodendron chinense, 14-25 parts of pomegranate peel, 14-25 parts of Gallnut, 10-22 parts of Portulaca oleracea, 12-26 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 12-18 parts of Angelica dahurica, and 8-16 parts of Lavender according to the weight. Remove impurities, wash and air-dry them separately, then grind them into coarse powder. Mix the coarse powders of each raw material. S2. Add a 75% (v / v) ethanol aqueous solution to the mixed raw material powder, and perform a first impregnation under sealed and light-proof conditions. Separate the solid and liquid to obtain a first extract and a residue. Add a 75% (v / v) ethanol aqueous solution to the residue for a second impregnation, and separate the solid and liquid to obtain a second extract. Combine the first extract and the second extract. S3. The combined extracts are subjected to coarse filtration and microporous membrane fine filtration in sequence. The filtrate after fine filtration is allowed to settle under light-proof and low-temperature conditions. The supernatant after settling is collected and the ethanol volume fraction of the supernatant is adjusted to 75%. S4. The supernatant after adjusting the ethanol volume fraction is sterilized and filtered, and then filled into a spray container in a clean environment to obtain the traditional Chinese medicine external spray.

6. The method for preparing the traditional Chinese medicine external spray for treating burns according to claim 5, characterized in that, In step S2, the mass of the 75% ethanol aqueous solution added for the first impregnation is 6 to 8 times the total mass of the raw material. The first impregnation lasts for 10 to 15 days at room temperature. The second impregnation uses the same volume fraction of ethanol aqueous solution as the first impregnation.

7. The method for preparing the traditional Chinese medicine external spray for treating burns according to claim 6, characterized in that, In step S3, the coarse filtration adopts plate and frame filtration, the microporous membrane fine filtration adopts a microporous filter membrane with a pore size of 0.45μm, the filtrate after fine filtration is allowed to settle in the dark at 5-15℃, and the supernatant is obtained by siphon.

8. The method for preparing the traditional Chinese medicine external spray for treating burns according to claim 7, characterized in that, In step S4, the sterilization filtration uses a sterilization filter membrane with a pore size of 0.22 μm, and the sterilized filtered medicine solution is sealed and filled into a spray container in a clean environment.

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