Traditional Chinese medicine compound preparation for cleaning wounds and preparation method thereof
Through scientific proportions and specific preparation methods of traditional Chinese medicine compound preparations, the problem of unstable efficacy of traditional Chinese medicine external preparations in the treatment of infectious wounds has been solved, and broad-spectrum antibacterial, healing promotion and biosafety have been achieved. It can adapt to the treatment needs of different wounds and is suitable for use in primary medical institutions.
Patent Information
- Application Number
- CN202511045695.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-29
- Publication Date
- 2025-09-26
AI Technical Summary
Existing Chinese herbal external-use preparations have the disadvantages of arbitrary formula proportions, simple and crude preparation processes, and single usage methods when treating infected wounds, resulting in unstable efficacy and difficulty in adapting to wounds of different infection degrees and types. In addition, the abuse of antibiotics leads to increased drug resistance, traditional antibiotics are expensive and have a long R&D cycle, and some patients are allergic to synthetic antibiotics.
The traditional Chinese medicine compound preparation is prepared by a precise combination of alum, sophora flavescens, cnidium monnieri, cassia twig and rhubarb through a specific preparation method. It contains matrine, oxymatrine, potassium aluminum sulfate, osthole, emodin and cinnamaldehyde. It adopts a process of step-by-step decoction and refrigerated storage, and provides two usage methods: cleaning and wet compress, which can adapt to wounds with different degrees of infection.
It significantly improves the therapeutic effect on chronic infected wounds, has broad-spectrum antibacterial properties, promotes healing, avoids allergic reactions and drug resistance to antibiotics, is simple and easy to use, has high biosafety, and is suitable for promotion in primary medical institutions.
Smart Images
Figure CN120695072A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of traditional Chinese medicine external preparations, in particular to a traditional Chinese medicine compound preparation for cleaning wounds and a preparation method thereof. Background Art
[0002] Currently, the mainstream clinical treatment for infected wounds is the combination of antibiotics and functional dressings. However, this approach has significant drawbacks. First, the long-term overuse of antibiotics has led to a rapid increase in pathogen resistance, even leading to the emergence of "superbugs" resistant to multiple antibiotics, significantly compromising treatment effectiveness. Second, the development of new antibiotics takes years and is costly, making it difficult to meet the clinical demand for effective, low-cost treatments. Furthermore, some patients experience allergic reactions to synthetic antibiotics, limiting their biosafety and further restricting their application.
[0003] Traditional Chinese Medicine (TCM) boasts a long history and unique advantages in the treatment of infected wounds. Studies have confirmed that traditional Chinese medicines such as Sophora flavescens, Alum, and Cnidium monnieri possess significant antimicrobial activity: matrine and oxymatrine in Sophora flavescens can disrupt bacterial cell membranes and inhibit nucleic acid synthesis; potassium aluminum sulfate in Alum exerts an antibacterial effect by interfering with bacterial energy metabolism while also astringing wound surfaces to reduce exudation; and osthole has a clear inhibitory effect on the growth of fungi (such as dermatophytes and Candida albicans). Based on 50 years of clinical experience by renowned Chinese medicine practitioners, the "Kufan Kushen Decoction" (a combination of Alum, Sophora flavescens, Cnidium monnieri, Cassia twig, and Rhubarb) has demonstrated promising results in the treatment of infected wounds. However, the standardization of its formulation, the standardization of its preparation process, and the clarification of its mechanism of action still require systematic research and optimization.
[0004] Existing external-use Chinese medicine preparations still have the following shortcomings: First, the formula ratio is very arbitrary, and there is a lack of precise dosage range research, resulting in unstable efficacy; second, the preparation process is simple and extensive, and the extraction process is not optimized according to the component characteristics of different medicinal materials, which may cause the loss of effective ingredients; third, the method of use is single, and it is difficult to adapt to different degrees of infection and different types of wounds (such as superficial infection and deep ulcers). Summary of the Invention
[0005] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine compound preparation for cleaning wounds and a preparation method thereof.
[0006] To achieve the above-mentioned purpose, the present invention provides the following technical solution: A Chinese medicine compound preparation for cleaning wounds of the present invention comprises the following raw materials in parts by weight: 8-12g of alum, 25-35g of sophora flavescens, 8-12g of cnidium monnieri, 8-12g of cassia twig, and 8-12g of rhubarb.
[0007] Preferably, the weight proportions of the raw materials are: 10 g of alum, 30 g of Sophora flavescens, 10 g of Cnidium monnieri, 10 g of Cinnamomum cassia twig, and 10 g of Rhubarb.
[0008] Further preferably, the active ingredients of Sophora flavescens include matrine and oxymatrine, the active ingredient of Alum is potassium aluminum sulfate, the active ingredient of Cnidium monnieri is osthole, the active ingredient of Rhubarb is emodin, and the active ingredient of Cinnamomum cassia is cinnamaldehyde.
[0009] Again preferably, a method for preparing a Chinese medicine compound preparation for cleaning wounds comprises the following preparation steps: S1. Weigh alum, sophora flavescens, cnidium monnieri, cassia twig, and rhubarb by weight and wrap them with non-woven fabric; S2. Add cold water and soak for 30 minutes. Bring to a boil over high heat and then simmer over low heat for 20 minutes. Add rhubarb and continue simmering for 10 minutes. Collect the liquid. S3. Add cold water again and boil again, combine the two medicinal solutions, divide into portions and store in the refrigerator. Rewarm to 37°C before use.
[0010] Preferably, the amount of water added for the two decoctions of S2 and S3 is 8-10 times the total weight of the raw materials, and the total amount of each dose of the combined medicinal liquid is 400-500 ml.
[0011] More preferably, the antibacterial spectrum of the liquid medicine obtained in step S3 includes: Staphylococcus aureus, Escherichia coli, Candida albicans, dermatophytes and Mycobacterium tuberculosis Again preferably, the liquid medicine obtained in step S3 includes a washing method and a wet compress method when used. The wet compress method is: soaking gauze with the liquid medicine, covering the wound surface and extending 2 cm beyond the wound edge, once a day, and continuously bandaging; for wounds with poor results, the liquid medicine soaking method is used, and each soaking time is 15-20 minutes; The cleaning method is: reheat the liquid to 37±1°C, and directly rinse the wound for 2-3 minutes, 1-2 times a day.
[0012] Compared with the prior art, the present invention provides a Chinese herbal compound preparation for cleaning wounds and a preparation method thereof, which has the following beneficial effects: This technical solution significantly improves the therapeutic effect on chronic infected wounds by scientifically combining a variety of Chinese medicinal materials and adopting a specific preparation method; Broad-spectrum antimicrobial: This technology, comprised of ingredients such as alum (potassium aluminum sulfate), Sophora flavescens (matrine, oxymatrine), Cnidium monnieri (osthole), Rhubarb (emodin), and Cinnamomum cassia (cinnamaldehyde), exhibits broad antimicrobial activity. It effectively inhibits a variety of pathogens, including Staphylococcus aureus, Escherichia coli, Candida albicans, dermatophytes, and Mycobacterium tuberculosis, reducing the risk of wound infection.
[0013] Promotes healing: The synergistic effect of these ingredients not only provides antibacterial and anti-inflammatory properties but also promotes tissue repair. In particular, the active ingredients in Sophora flavescens help accelerate wound healing, while the alum has astringent and hemostatic properties, further enhancing wound recovery and significantly reducing symptoms such as redness, swelling, and pus oozing.
[0014] Gentle and non-irritating: The optimized formula ensures the liquid is gentle and non-irritating to the skin during use, avoiding the allergic reactions and drug resistance that can occur with traditional antibiotics. Furthermore, the liquid undergoes a double decoction process to effectively extract and concentrate the active ingredients of the medicinal materials, enhancing the therapeutic effect.
[0015] Ease of Use: The preparation method is simple, making it suitable for widespread use in primary healthcare institutions. The solution is refrigerated after packaging and can be directly applied by simply rewarming to 37°C before use. Two application methods are available: wet compress and soaking, allowing for flexible selection based on the patient's specific needs, enhancing applicability and ease of use.
[0016] Excellent biosafety: All raw materials are common, widely sourced, safe, and reliable traditional Chinese medicines. The finished product undergoes rigorous quality testing to ensure its biosafety meets relevant standards. It is suitable for all populations, especially those with limited financial resources. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Figure 1 Schematic diagram of the configuration flow of the present invention. DETAILED DESCRIPTION
[0018] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.
[0019] See also Figure 1 The present invention provides a traditional Chinese medicine compound preparation for cleaning wounds, comprising the following raw materials in parts by weight: 8-12g of alum, 25-35g of sophora flavescens, 8-12g of cnidium monnieri, 8-12g of cassia twig, and 8-12g of rhubarb.
[0020] This technical solution is based on the core mechanism of "multi-component synergistic antibacterial + wound microenvironment regulation + promotion of tissue repair". Through the precise combination of alum, sophora flavescens, cnidium monnieri, cassia twig and rhubarb, it can achieve the cleaning, antibacterial and healing promotion of infected wounds. Its core logic is: The various active ingredients in the compound (such as matrine, potassium aluminum sulfate, osthole, etc.) exert broad-spectrum antibacterial effects by destroying the structure of pathogens and inhibiting their metabolism and reproduction; The drug ingredients synergistically regulate inflammatory responses, reduce wound exudation, and create a moist environment conducive to healing; The medicinal solution prepared by a specific process is applied to the wound surface through cleaning, wet compressing or soaking, directly contacting the pathogens and penetrating into the tissue, taking into account both local antibacterial effects and improvement of systemic inflammation, and is not prone to causing drug resistance.
[0021] Formula composition and active ingredient effects Core ingredients (by weight): 8-12g of alum, 25-35g of Sophora flavescens, 8-12g of Cnidium monnieri, and 8-12g of cassia twig; The preferred formula is 10g of kudzu root, 30g of sophora flavescens, 10g of cnidium monnieri, 10g of cassia twig, and 10g of rhubarb. This ratio, optimized based on the clinical experience of renowned traditional Chinese medicine practitioners, ensures the dominant effect of sophora flavescens (its core antibacterial ingredient) while also enhancing the synergistic effects of kudzu root (astringent) and cnidium monnieri (antifungal), avoiding the irritation caused by excessive concentrations of any single ingredient.
[0022] The selection conditions of each medicinal material in this technical solution are: alum (purity ≥98%), Sophora flavescens (origin in Shanxi, slice thickness 2-4mm), Cnidium monnieri (purified, free of impurities), cinnamon twig (diameter 0.3-0.5cm), and rhubarb (raw product, slice thickness 3-5mm).
[0023] Active ingredients and mechanism of action: Sophora flavescens (matrine, oxymatrine): As a core antibacterial ingredient, it can destroy the integrity of the cell membrane / cell wall of bacteria (such as Staphylococcus aureus, Mycobacterium tuberculosis) and fungi (Candida albicans), inhibit nucleic acid synthesis, and at the same time reduce the levels of inflammatory factors (IL-6, TNF-α) by regulating the NF-κB pathway, thereby reducing the redness, swelling, heat and pain of the wound.
[0024] Alum (potassium aluminum sulfate): It destroys the permeability of bacterial cell membranes through Al³⁺, inhibits the activity of key enzymes such as succinate dehydrogenase, and interferes with the energy metabolism of pathogens; at the same time, it exerts an astringent effect, reduces wound exudation, dries the wound surface to inhibit the reproduction of pathogens.
[0025] Cnidium monnieri (osthole): It has antibacterial effects against fungi (dermatophytes, Candida) and bacteria (Staphylococcus aureus) by destroying cell membranes and inhibiting hyphae development, while also regulating T cell function and reducing damage to tissues caused by excessive immune responses.
[0026] Rhubarb (rhubarb root): It inhibits bacterial DNA topoisomerase and RNA polymerase, interferes with nucleic acid synthesis, and has an inhibitory effect on both Gram-positive and Gram-negative bacteria; its heat-clearing and fire-purging effects can indirectly reduce the overgrowth of intestinal bacteria and reduce the risk of systemic infection.
[0027] Cinnamon twig (cinnamaldehyde): auxiliary antibacterial (effective against Staphylococcus aureus and Escherichia coli), mainly by improving local blood circulation, enhancing immune cell chemotaxis, promoting the penetration of other drug ingredients into the wound tissue, and improving the overall therapeutic effect.
[0028] Preparation process principle The scientific nature of step-by-step decoction: First, decoct alum, Sophora flavescens, Cnidium monnieri, and cassia twig (boil over high heat and then simmer over low heat for 20 minutes): the active ingredients of these herbs (such as alkaloids and volatile oils) require a longer decocting time to fully dissolve, and decocting over low heat can avoid excessive loss of volatile oils (such as cinnamaldehyde in cassia twig).
[0029] Then add rhubarb and simmer for 10 minutes: the anthraquinone components (emodin) in rhubarb are easily soluble in water and easily destroyed by long-term boiling. Short-term boiling can retain its antibacterial activity.
[0030] Decoction twice and combine the medicinal solutions: the first decoction extracts the easily soluble components, and the second decoction makes full use of the residual effective ingredients of the medicinal materials. The amount of water added is 8-10 times the total weight of the raw materials (to ensure that the ingredients are fully dissolved). After combination, each dose is 400-500ml, which ensures the appropriate concentration (to avoid excessive concentration that irritates the wound) and meets the needs of multiple uses.
[0031] Refrigerated storage and rewarming: Refrigeration at 4°C can inhibit microbial contamination and extend the shelf life of the drug solution (≥7 days); rewarm to 37°C (close to human body temperature) before use to avoid low temperature irritation to the wound surface, which may cause vasoconstriction and affect drug absorption and tissue repair.
[0032] Usage and antimicrobial spectrum Diverse usage: Wet compress: Soak gauze with the drug solution and cover the wound with it 2 cm beyond the edge. The sustained-release effect of the gauze allows the drug to continuously contact the wound (8-12 hours). It is suitable for moderate to mild infected wounds. Applying once a day can maintain effective drug concentration.
[0033] Soaking method: For wounds with heavy exudation and poor wet dressing effect (such as diabetic foot ulcers), soak for 15-20 minutes each time, using the liquid environment to allow the drug to fully penetrate the wound edge and deep tissues to enhance the antibacterial effect.
[0034] Cleaning: Directly flushing the wound with liquid medicine can remove surface purulent secretions and necrotic tissue, creating a clean environment for subsequent treatment.
[0035] Broad-spectrum antibacterial effect: The drug has inhibitory effects on Staphylococcus aureus (Gram-positive bacteria), Escherichia coli (Gram-negative bacteria), Candida albicans (fungus), dermatophytes (fungus) and Mycobacterium tuberculosis, covering common pathogens of infected wounds and solving the problem of limited antibacterial spectrum of a single antibiotic.
[0036] Detailed workflow Stage 1: Raw material preparation and weighing Select Chinese medicinal materials that meet the pharmacopoeia standards: alum (purity ≥98%), Sophora flavescens (thickness of the slices 2-4mm), Cnidium monnieri (purified and free of impurities), cinnamon twig (diameter 0.3-0.5cm), and rhubarb (raw slices, thickness 3-5mm).
[0037] Weigh according to the preferred weight: 10g of alum, 30g of Sophora flavescens, 10g of Cnidium monnieri, 10g of cinnamon twig, and 10g of rhubarb, and put them into non-woven medicine bags respectively (to avoid the herbs from scattering during decoction).
[0038] Phase 2: Preparation of drug solution First decoction: Place the medicine bags of alum, Sophora flavescens, Cnidium monnieri, and cassia twig into an automatic decoction machine, add 800ml of cold water (8 times the total weight of the raw materials), and soak for 30 minutes (to allow the medicinal materials to fully absorb water).
[0039] Bring to a boil over high heat (1000W), then reduce to low heat (500W) and simmer for 20 minutes, stirring 1-2 times to ensure even heating.
[0040] Add rhubarb and boil: add rhubarb bag, continue to boil on low heat for 10 minutes, and collect the first liquid (about 300ml).
[0041] Second decoction: Add 600ml of cold water (6 times the total weight of the raw materials) to the medicinal residue, boil over high heat, then simmer over low heat for 15 minutes, and collect the second medicinal liquid (about 200ml).
[0042] Combination and storage: Mix the two liquid medicines (total volume of about 450 ml), package them in 3 bags with a sterile packaging machine, each bag containing 150 ml, and store them in a refrigerator at 4°C (shelf life 7 days).
[0043] Phase 3: Wound treatment and medication Preoperative preparation: Remove the refrigerated solution and rewarm it to 37°C in a 37°C water bath; clean the skin around the wound according to routine aseptic techniques and remove obvious necrotic tissue and purulent secretions.
[0044] Medication method selection: For mild to moderately infected wounds (little exudation): soak 1 bag of liquid medicine in sterile gauze (3-4 layers thick), cover the wound and extend 2cm beyond the edge, and bandage with sterile dressing, once a day.
[0045] For wounds with severe infection or heavy exudation (such as pressure sores): Use the immersion method to immerse the wound in 37°C solution for 15-20 minutes each time, once a day; after soaking, use sterile gauze to gently press and absorb the surface solution, without bandaging.
[0046] Treatment course: Use continuously for 7-14 days, and adjust according to the wound healing situation (it can be changed to wet compress after the wound shrinks and exudation decreases).
[0047] Phase 4: Efficacy observation and adjustment Observe wound surface changes daily: record exudate (none / small / moderate / large), degree of redness and swelling, and pain score (VAS score).
[0048] Evaluation after 3 days of medication: If the redness and swelling of the wound are reduced and the exudation is reduced, continue with the original plan; if the symptoms do not improve, check for deep infection and increase the number of soaking times (twice a day) or combine with debridement.
[0049] Cure criteria: complete epithelialization of the wound, no exudation, disappearance of pain, and return of serum inflammatory indicators (WBC, CRP) to normal.
[0050] Clinical application examples Patient screening: 30 patients with infected wounds were randomly divided into a treatment group (15 cases) and a control group (15 cases). Inclusion criteria: wound area 2-10 cm², infection time ≥ 7 days, WBC> 10×10 9 / L, CRP>10mg / L. Exclusion criteria: allergy to traditional Chinese medicine, liver and kidney dysfunction.
[0051] Treatment: Control group: Dressing was changed according to the TIME principle (debridement, inflammation control, and maintenance of a moist environment), and a new functional dressing was applied externally (once daily), combined with intravenous infusion of sensitive antibiotics; Treatment group: Based on the TIME principle of dressing change, the patients were given a wet compress of the Chinese herbal compound of the present invention (once a day), with gauze soaked in the medicine covering the wound surface and extending 2 cm beyond the wound, combined with the same type of antibiotics; for those with more exudation, the patients were soaked in the medicine solution (37°C, 20 minutes each time).
[0052] Observation indicators: Healing time: The average healing time in the treatment group (14.2±2.5 days) was significantly shorter than that in the control group (17.8±3.1 days) (P<0.05); Inflammatory indicators: After 7 days of treatment, the serum CRP (8.5±2.1mg / L) and WBC (7.2±1.3×10 9 / L) were lower than those in the control group (12.3±3.2 mg / L, 9.8±1.5×10 9 / L) (P < 0.05); Cure rate: The cure rate in the treatment group was 86.7% (13 / 15), and that in the control group was 60% (9 / 15). The incidence of adverse reactions was 3.3% (local mild itching) in the treatment group and 13.3% (rash) in the control group.
[0053] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.
Claims
1. A Chinese medicinal compound preparation for cleaning wounds, characterized in that: The invention comprises the following raw materials in parts by weight: 8-12g of alum, 25-35g of sophora flavescens, 8-12g of cnidium monnieri, 8-12g of cassia twig and 8-12g of rhubarb.
2. A Chinese medicinal compound for cleaning wounds according to claim 1, characterized in that: The weight proportions of the raw materials are as follows: 10g of alum, 30g of Sophora flavescens, 10g of Cnidium monnieri, 10g of Cinnamomum cassia twig, and 10g of Rhubarb.
3. A Chinese medicinal compound preparation for cleaning wounds according to claim 2, characterized in that: The active ingredients of Sophora flavescens include matrine and oxymatrine, the active ingredient of Alum is potassium aluminum sulfate, the active ingredient of Cnidium monnieri is osthole, the active ingredient of Rhubarb is emodin, and the active ingredient of Cinnamomum cassia is cinnamaldehyde.
4. A method for preparing a Chinese herbal compound preparation for cleaning wounds, according to any one of claims 1 to 3, wherein: The method comprises the following preparation steps: S1. Weigh alum, sophora flavescens, cnidium monnieri, cassia twig, and rhubarb by weight and wrap them with non-woven fabric; S2. Add cold water and soak for 30 minutes. Bring to a boil over high heat and then simmer over low heat for 20 minutes. Add rhubarb and continue simmering for 10 minutes. Collect the liquid. S3. Add cold water again and boil again, combine the two medicinal solutions, divide into portions and store in the refrigerator. Rewarm to 37°C before use.
5. The method for preparing a Chinese medicinal compound preparation for cleaning wounds according to claim 4, wherein: The amount of water added for the two decoctions of S2 and S3 is 8-10 times the total weight of the raw materials, and the total amount of each dose of the medicinal liquid after combination is 400-500 ml.
6. The method for preparing a Chinese medicinal compound preparation for cleaning wounds according to claim 5, wherein: The antibacterial spectrum of the medicinal solution obtained in step S3 includes: Staphylococcus aureus, Escherichia coli, Candida albicans, dermatophytes and Mycobacterium tuberculosis.
7. The method for preparing a Chinese medicinal compound preparation for cleaning wounds according to claim 6, wherein: The liquid medicine obtained in step S3 can be used in a cleaning method or a wet compress method. The wet compress method is: soak gauze with the liquid medicine, cover the wound surface and extend 2 cm beyond the wound edge, once a day, and continue bandaging. For wounds with poor results, the liquid medicine soaking method is used, and each soaking time is 15-20 minutes. The cleaning method is: reheat the liquid to 37±1°C, and directly rinse the wound for 2-3 minutes, 1-2 times a day.