Traditional Chinese medicine extracting solution for promoting healing of burns and scalds and preparation process

Abstract

The invention relates to the technical field of traditional Chinese medicines, and solves the problems that the traditional Chinese medicine compound preparation is limited to a high-temperature decoction or alcohol extraction process, so that effective components are degraded, the content of healing promoting components is insufficient, an extracting solution contains macromolecular impurities, anaphylactic reaction is easily caused, and the stability of the preparation is reduced. The traditional Chinese medicine extracting solution is prepared from the following raw materials in parts by weight: 12 to 18 parts of herba artemisiae scopariae, 8 to 12 parts of rhizoma coptidis, 8 to 12 parts of herba adiantum capillus, 3 to 7 parts of caesalpinia cucullata and 80 to 120 parts of edible white spirit with the concentration of 50 to 60 percent vol. The preparation process of the extracting solution comprises the following steps: raw material pretreatment, crushing and sieving, low-temperature extraction, solid-liquid separation, aging treatment and finished product preparation. The method has the advantages that the process is refined, the temperature is accurately regulated and controlled, and active ingredients are reserved to the maximum extent; the purity and the stability of the extracting solution are guaranteed; and the quantitative ratio is optimized, and the effectiveness is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine extract for promoting the healing of burns and scalds and a preparation process thereof. Background Art

[0002] Burn wounds are characterized by high exudation, susceptibility to infection, and impaired tissue repair. The continuous release of inflammatory factors destroys the microcirculation of the wound, hinders fibroblast proliferation, and disrupts collagen deposition, leading to slow granulation tissue formation, delayed epithelialization, and a high risk of residual scars. Existing treatment methods are through chemical drugs and biological agents or the use of traditional Chinese medicine compound prescriptions.

[0003] Traditional Chinese medicine compound has unique advantages in astringency, hemostasis, anti-inflammation and tissue regeneration, but also has some shortcomings:

[0004] 1. High-temperature decoction or alcohol extraction processes destroy heat-sensitive active substances (such as flavonoids and alkaloids), resulting in insufficient content of healing-promoting ingredients;

[0005] 2. The crude extract contains macromolecular impurities such as tannins and proteins, which can easily cause allergic reactions and reduce the stability of the preparation;

[0006] 3. Terminal high-temperature sterilization (such as boiling) exacerbates the degradation of components, while conventional filtration sterilization is not thorough and cannot meet the requirements for aseptic treatment of wounds. Summary of the Invention

[0007] The present invention aims to solve the problems that the preparation of the above-mentioned traditional Chinese medicine compound is limited by high-temperature decoction or alcohol extraction process, which leads to degradation of effective ingredients, insufficient content of healing-promoting ingredients, the extract contains large molecular impurities, easily induces allergic reactions and reduces the stability of the preparation. The present invention provides a Chinese medicine extract for promoting the healing of burns and scalds and a preparation process.

[0008] To solve the above technical problems, the present invention provides a technical solution: a Chinese medicine extract for promoting the healing of burns and scalds and a preparation process thereof, which is prepared from the following raw materials in parts by weight:

[0009] 12-18 parts of Artemisia capillaris, 8-12 parts of Coptis chinensis, 8-12 parts of Herba Lycopodii, 3-7 parts of Herba Cyperi, and 80-120 parts of edible liquor with a concentration of 50-60% vol;

[0010] Among them, Coptis chinensis (containing berberine) and Herba Lycopodii (containing alkaloids) synergistically exert a strong hemostatic effect, quickly controlling bleeding by constricting blood vessels and promoting platelet aggregation; Artemisia capillaris (berberine and chlorogenic acid) has significant astringency, can reduce tissue fluid exudation, and relieve wound edema; Artemisia capillaris (chlorogenic acid) and Herba Lycopodii (total flavonoids) have both broad-spectrum antibacterial and anti-inflammatory activities, clearing pathogenic microorganisms from the wound and inhibiting inflammatory responses; Herba Lycopodii ingredients directly stimulate fibroblast proliferation and collagen synthesis, accelerate granulation tissue formation and epithelial regeneration, and are added to white wine for soaking. The purpose of adding white wine is to reduce inflammation and prevent wound infection. Another benefit of adding wine is that it facilitates the shelf life and storage of drugs. When treating burns and scalds, applying the medicine to the affected area (or spraying) will immediately relieve pain, shrink moisture quickly, and there will be no water flow from the affected area in a short time. The skin will be automatically repaired without scars.

[0011] The preparation process of the extract comprises the following steps:

[0012] S1: Raw material pretreatment: remove impurities from Artemisia capillaris, Coptis chinensis, Herba Lycopodii and Herba Cyperi, wash with clean water and place in a cool place to dry naturally;

[0013] Removing impurities and washing with clean water ensure the purity of the raw materials and avoid external contamination. Drying them naturally in a cool place avoids the loss of volatile components or damage to heat-sensitive components that may be caused by high-temperature drying, preserving the original medicinal properties of the raw materials to the greatest extent possible.

[0014] S2: Grinding and screening: Use a circulating water-cooled grinder to grind the dried medicinal materials into 80-120 mesh to obtain a mixed coarse powder;

[0015] Among them, the circulating water-cooled grinder can effectively control the heat generated during the grinding process, preventing the oxidation, decomposition or denaturation of medicinal components (especially volatile and heat-sensitive components) caused by high temperature. The appropriate fineness increases the contact area between the medicinal materials and the solvent, improving the extraction efficiency; at the same time, it avoids the difficulty of filtering caused by excessively fine powder and the extraction of excessive ineffective components.

[0016] S3: Low temperature extraction: Mix the mixed coarse powder with white wine in a weight ratio of 1:(4-6), place in a sealed container and soak at 15-25℃ for 15-30 days, stirring 3-5 times a day;

[0017] Among them, the low temperature environment avoids the destruction of heat-sensitive active ingredients (such as certain glycosides, volatile oils, and alkaloids) caused by high temperature, retains the original active ingredients and flavor substances of the medicinal materials to the greatest extent, ensures sufficient dissolution time, and allows the ingredients to slowly and fully diffuse from the medicinal materials into the solvent.

[0018] S4: solid-liquid separation: first use a 200-mesh filter for preliminary filtration, then use a ceramic membrane filtration system for fine filtration, and collect the filtrate;

[0019] Among them, the fine filtration of the ceramic membrane filtration system can effectively remove fine particles, colloids, some macromolecular impurities, and even some microorganisms, significantly improving the clarity and stability of the extract, and reducing the burden on subsequent aging and sterilization filtration.

[0020] S5: Aging treatment: transfer the filtrate to a brown glass container and age it at 0-4°C for 30-60 days;

[0021] Among them, low temperature (0-4℃) can inhibit the growth of microorganisms, slow down the rate of chemical reactions, and facilitate precipitation.

[0022] S6: Finished product preparation: The aged extract is finally sterilized by filtration through a 0.22 μm microporous filter membrane and dispensed into sterile containers;

[0023] Among them, the microporous filter membrane can effectively intercept bacteria, molds and yeasts, achieving a sterile or near-sterile state (in line with microbial index requirements), while avoiding the destruction of heat-sensitive components by high-temperature sterilization (such as boiling and high-pressure sterilization), and retaining the activity of effective ingredients to the greatest extent.

[0024] Furthermore, the preferred weight ratio of the raw materials is: 15 parts of Artemisia capillaris, 10 parts of Coptis chinensis, 10 parts of Herba Lycopodii, 5 parts of Herba Cyperi, and 100 parts of edible liquor.

[0025] Among them, a reasonable range and clear preferred values are provided, which not only ensure the flexibility of the formula to adapt to the differences in raw material batches, but also provide a verified optimal ratio benchmark to ensure the stability of effect and quality.

[0026] Furthermore, the crushing process in step S2 adopts a segmented crushing process:

[0027] a) Initial crushing: crush the medicinal materials into 40-60 mesh;

[0028] b) Ultrasonic treatment: The primary crushed material is subjected to 20kHz ultrasonic treatment for 15-20 minutes. The cavitation effect, mechanical vibration and thermal effect of ultrasound are used to strongly destroy the plant cell walls, making it easier to release the active ingredients in the cells;

[0029] c) Secondary pulverization: The material after ultrasonic treatment is further pulverized to 80-120 mesh. On the basis that the cell wall has been destroyed by ultrasonic waves, it is easier to achieve the target fineness, further increase the surface area, and significantly improve the subsequent extraction efficiency and yield.

[0030] Furthermore, the aging treatment in step S5 includes a gradient cooling program:

[0031] a) Initial stage (0-15 days): Maintain a constant temperature of 4°C to start the precipitation process at a relatively mild low temperature;

[0032] b) Mid-term stage (16-30 days): Cool down to 0°C at a rate of 0.5°C / day. Slow cooling promotes more orderly and complete precipitation of components whose solubility decreases with temperature (such as higher alcohols, esters, and certain impurities), and avoids rapid cooling that may cause precipitation to encapsulate active ingredients or form unstable fine suspended matter.

[0033] c) Final stage (31-60 days): Maintain a constant temperature of 0°C and allow the solution to stand at the lowest temperature for a long time to ensure complete precipitation and maximum stability and clarity of the solution.

[0034] Furthermore, the active ingredient content of the extract meets the following indicators:

[0035] Berberine (calculated as Coptis chinensis) ≥0.8mg / mL; chlorogenic acid (calculated as Artemisia capillaris) ≥1.2mg / mL; total flavonoids (calculated as Achyranthes bidentata) ≥2.5mg / mL; alkaloids (calculated as Hematoxylin and Leuconostoc) ≥0.5mg / mL; and the microbial indicators meet the requirements: total bacterial count ≤10CFU / mL, total mold and yeast count ≤5CFU / mL, and pathogenic bacteria must not be detected.

[0036] Furthermore, the sterilization filtration in step S6 comprises:

[0037] a) pH adjustment: Use food-grade sodium bicarbonate to adjust the pH of the extract to 6.8-7.2, which helps to improve the stability of the Chinese herbal extract in the extract and reduce the irritation of the extract to the skin;

[0038] b) Aseptic filling: Nitrogen filling is carried out in a Class A clean area, and the error of each bottle filling volume is controlled within ±1%.

[0039] Among them, by filling the container with inert gas nitrogen before filling and discharging the headspace oxygen, it can effectively prevent the active ingredients (such as phenols, flavonoids, and easily oxidized ingredients) from being oxidized and deteriorated after filling and during storage, extend the shelf life of the product, and maintain the color and flavor.

[0040] The advantages of the present invention are:

[0041] 1. Refined technology and precise temperature control maximize the retention of active ingredients. From raw material drying, water-cooled crushing, low-temperature extraction, gradient cooling aging to terminal sterilization and filtration, high-temperature links are avoided throughout the process. Furthermore, refined processes such as segmented crushing + ultrasonic wall breaking, ceramic membrane fine filtration, and gradient aging are used to maximize the protection of the activity and content of heat-sensitive, photosensitivity, and easily oxidized active ingredients (such as berberine, chlorogenic acid, flavonoids, and alkaloids), ensuring that the final product meets strict active ingredient content indicators.

[0042] 2. Ensure the purity and stability of the extract. Through strict raw material purification, ceramic membrane fine filtration, gradient low-temperature aging, terminal sterilization filtration, aseptic nitrogen filling, and pH adjustment, the product achieves high clarity and good stability. The low-temperature preparation (extraction and aging) throughout the entire process effectively protects heat-sensitive hemostatic components (such as hemostatic alkaloids) and healing factors.

[0043] 3. Optimize the quantitative ratio to improve the effectiveness of the present invention. Use the preferred ratio (15 grams of Artemisia capillaris / 10 grams of Coptis chinensis / 10 grams of Herba Lycopodii / 5 grams of Herba Cyperi / 100 grams of Liquor) and a reasonable range to achieve the extract's strong astringency and hemostasis, promote tissue repair and wound healing, reduce patient pain, shorten the burn recovery period, and repair the skin so that there are no obvious scars after recovery. DETAILED DESCRIPTION

[0044] To make the objects, features, and advantages of the present invention more readily apparent, the following detailed description of the specific embodiments of the present invention is provided in conjunction with the following examples. Several embodiments of the present invention are provided in the examples. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these examples are provided to provide a more thorough and comprehensive understanding of the present invention.

[0045] A Chinese medicine extract for promoting the healing of burns and scalds and its preparation process, with the following raw material ratios:

[0046] 150g of Artemisia capillaris, 100g of Coptis chinensis, 100g of Herba Lycopodii, 50g of Herba Cyperi, and 1000mL of 55%vol edible liquor.

[0047] Preparation process:

[0048] Raw material pretreatment:

[0049] Select the whole herbs of Artemisia capillaris, Coptis chinensis, and Clerodendrum truncatum and their rhizomes, and remove the mud, sand and non-medicinal parts.

[0050] Rinse with running water for 3 times, spread flat on a ventilated screen, and dry naturally in a cool place at 25℃ until the moisture content is ≤8%.

[0051] Crushing and screening:

[0052] Segmented crushing:

[0053] a) Primary pulverization: Use a circulating water-cooled pulverizer (speed 1800 rpm) to coarsely crush the medicinal materials to 50 mesh;

[0054] b) Ultrasonic treatment: The coarse powder was placed in an ultrasonic processor and treated at a frequency of 20 kHz for 18 minutes;

[0055] c) Secondary crushing: Continue crushing to 100 mesh, pass through a 100 mesh vibrating sieve, and collect the mixed coarse powder.

[0056] Low temperature extraction:

[0057] The mixed coarse powder and white wine were mixed in a weight ratio of 1:5 (total mass 1500 g) and placed in a 304 stainless steel sealed tank.

[0058] The ambient temperature was controlled at 20°C ± 2°C, and the culture was immersed for 25 days. Stirring was performed with a sterile paddle 4 times a day (60 rpm), each time for 10 minutes.

[0059] Solid-liquid separation:

[0060] Primary filtration: 200-mesh stainless steel filter to remove large particles of residue;

[0061] Fine filtration: Use a ceramic membrane filtration system with a pore size of 0.1 μm (operating pressure 0.2 MPa) to collect the transparent filtrate.

[0062] Aging treatment:

[0063] Transfer the filtrate to a brown glass jar and process according to the gradient cooling program:

[0064] a) Days 0-15: Keep at a constant temperature of 4°C;

[0065] b) 16-30 days: reduce the temperature by 0.5°C daily to 0°C;

[0066] c) Days 31-60: Maintain a constant temperature of 0°C.

[0067] Finished product preparation:

[0068] The aged solution was sterile filtered through a 0.22 μm polyethersulfone microporous filter membrane;

[0069] Adjust pH to 7.0 with food-grade sodium bicarbonate;

[0070] Nitrogen filling is carried out in a Class A clean area (ISO5), with each bottle containing 100 mL and a filling error of ±0.5 mL.

[0071] Quality inspection: Active ingredients: berberine 1.12 mg / mL, chlorogenic acid 1.58 mg / mL, total flavonoids 3.05 mg / mL, alkaloids 0.62 mg / mL; Microorganisms: total bacteria 3 CFU / mL, no mold / yeast detected, no pathogenic bacteria detected.

[0072] Example 2

[0073] Raw material ratio:

[0074] 120g of Artemisia capillaris, 80g of Coptis chinensis, 80g of Herba Lycopodii, 30g of Herba Cyperi, and 800mL of 50%vol edible liquor.

[0075] Process adjustment: the medicinal materials were crushed to 80 mesh, low-temperature extracted for 15 days (15°C environment), aged for 30 days (directly maintained at 0°C), and the remaining steps were the same as in Example 1.

[0076] Quality inspection: Active ingredients: berberine 0.85 mg / mL, chlorogenic acid 1.25 mg / mL, total flavonoids 2.68 mg / mL, alkaloids 0.53 mg / mL, microbial indicators meet the standards.

[0077] Example 3

[0078] Raw material ratio: 180g of Artemisia capillaris, 120g of Coptis chinensis, 120g of Herba Lycopodii, 70g of Herba Cyperi, and 1200mL of edible liquor with a concentration of 60%vol.

[0079] Process adjustment: crush to 120 mesh, low-temperature extraction for 30 days (25°C environment), aging for 60 days (including gradient cooling), and the remaining steps are the same as Example 1.

[0080] Quality inspection: Active ingredients: berberine 1.35 mg / mL, chlorogenic acid 1.82 mg / mL, total flavonoids 3.41 mg / mL, alkaloids 0.75 mg / mL, microbial indicators meet the standards.

[0081] Example 4

[0082] The raw material ratio is the same as that in Example 1, but the following steps are omitted: ultrasonic treatment is not performed during the pulverization process; and the aging treatment is directly performed at a constant temperature of 4°C for 60 days.

[0083] Quality inspection: active ingredients: berberine 0.72 mg / mL, chlorogenic acid 0.98 mg / mL (significantly lower than Example 1), microbial indicators: total bacterial count 25 CFU / mL (exceeding the standard).

[0084] The above description of the present invention and its embodiments is non-limiting, and the actual structure is not limited thereto. In short, if a person skilled in the art is inspired by the above description and, without departing from the purpose of the present invention, designs a structure and embodiment similar to the technical solution without creatively designing, they shall fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine extract for promoting the healing of burns and scalds and a preparation process thereof, characterized in that: It is prepared from the following raw materials in parts by weight: 12-18 parts of Artemisia capillaris, 8-12 parts of Coptis chinensis, 8-12 parts of Herba Lycopodii, 3-7 parts of Herba Cyperi, and 80-120 parts of edible liquor with a concentration of 50-60% vol; The preparation process of the extract comprises the following steps: S1: Raw material pretreatment: remove impurities from Artemisia capillaris, Coptis chinensis, Herba Lycopodii and Herba Cyperi, wash with clean water and place in a cool place to dry naturally; S2: Grinding and screening: Use a circulating water-cooled grinder to grind the dried medicinal materials into 80-120 mesh to obtain a mixed coarse powder; S3: Low temperature extraction: Mix the mixed coarse powder with white wine in a weight ratio of 1:(4-6), place in a sealed container and soak at 15-25℃ for 15-30 days, stirring 3-5 times a day; S4: solid-liquid separation: first use a 200-mesh filter for preliminary filtration, then use a ceramic membrane filtration system for fine filtration, and collect the filtrate; S5: Aging treatment: transfer the filtrate to a brown glass container and age it at 0-4°C for 30-60 days; S6: Finished product preparation: The aged extract is finally sterilized by filtration through a 0.22 μm microporous filter membrane and dispensed into sterile containers.

2. The Chinese medicinal extract for promoting the healing of burns and scalds and its preparation process according to claim 1, characterized in that: The preferred weight ratio of the raw materials is: 15 parts of Artemisia capillaris, 10 parts of Coptis chinensis, 10 parts of Herba Lycopodii, 5 parts of Herba Cyperi, and 100 parts of edible liquor.

3. The Chinese medicinal extract for promoting the healing of burns and scalds and its preparation process according to claim 1, characterized in that: The pulverization process in step S2 adopts a segmented pulverization process: a) Initial crushing: crush the medicinal materials into 40-60 mesh; b) Ultrasonic treatment: The primary pulverized material is subjected to 20 kHz ultrasonic treatment for 15-20 minutes; c) Secondary crushing: the material after ultrasonic treatment is further crushed to 80-120 mesh.

4. The Chinese medicinal extract for promoting the healing of burns and scalds and its preparation process according to claim 1, characterized in that: The aging treatment in step S5 includes a gradient cooling process: a) Initial stage (0-15 days): Maintain a constant temperature of 4°C; b) Middle stage (16-30 days): Cool down to 0°C at a rate of 0.5°C / day; c) Final stage (31-60 days): Maintain a constant temperature of 0°C.

5. The Chinese medicinal extract for promoting the healing of burns and scalds and its preparation process according to claim 1, characterized in that: The content of the active ingredient in the extract meets the following indicators: Berberine (calculated as Coptis chinensis) ≥0.8mg / mL; chlorogenic acid (calculated as Artemisia capillaris) ≥1.2mg / mL; total flavonoids (calculated as Achyranthes bidentata) ≥2.5mg / mL; alkaloids (calculated as Hematoxylin and Leuconostoc) ≥0.5mg / mL; and the microbial indicators meet the requirements: total bacterial count ≤10CFU / mL, total mold and yeast count ≤5CFU / mL, and pathogenic bacteria must not be detected.

6. The Chinese medicinal extract for promoting the healing of burns and scalds and its preparation process according to claim 1, characterized in that: The sterilization filtration of step S6 comprises: a) pH adjustment: Use food grade sodium bicarbonate to adjust the pH of the extract to 6.8-7.2; b) Aseptic filling: Nitrogen filling is carried out in a Class A clean area, and the error of each bottle filling volume is controlled within ±1%.