A traditional Chinese medicine composition for wound healing and its preparation method

Abstract

This invention relates to the field of traditional Chinese medicine composition technology, and discloses a traditional Chinese medicine composition for wound healing and its preparation method. The composition for the early stage includes: 10-12 parts rhubarb, 5-6 parts coptis, 10-12 parts scutellaria, 10-12 parts phellodendron, 10-12 parts corydalis, 6-7 parts notoginseng, 5-6 parts cattail pollen, 4-5 parts dragon's blood, 10-12 parts burnet root, 10-13 parts mulberry twig, and 10-12 parts gallnut. The composition for the middle stage includes: 10-12 parts astragalus and 10-12 parts angelica. The herbal composition for later stages includes: 10-12 parts of Salvia miltiorrhiza, 10-12 parts of talc, 10-12 parts of mulberry twig, 10-12 parts of gallnut, 10-12 parts of Ligusticum chuanxiong, 4-5 parts of dragon's blood, 10-12 parts of frankincense, and 10-12 parts of myrrh; 10-12 parts of Astragalus membranaceus, 10-12 parts of Dipsacus asper, 10-12 parts of Angelica sinensis, 10-12 parts of Ligusticum chuanxiong, 10-12 parts of gallnut, 10-12 parts of mulberry twig, 10-12 parts of Codonopsis pilosula, 10-12 parts of Salvia miltiorrhiza, 10-12 parts of Morinda officinalis, and 10-12 parts of talc. This invention divides wound treatment into three stages, which can significantly improve the cure rate of chronic refractory wounds (CRW), inhibit inflammatory factors, and promote tissue regeneration.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for wound healing and its preparation method. Background Technology

[0002] Chronic refractory wounds (CRWs) are a common type of wound in clinical practice. They specifically refer to wounds caused by various factors such as trauma, infection, and diabetes, which, despite standardized treatment, fail to reach clinical healing standards within one month and remain in a state of inflammatory response and stagnant tissue repair. In the theoretical system of Traditional Chinese Medicine (TCM), CRWs fall under the categories of "sores," "ulcers," "stubborn sores," and "carbuncles." Their core pathogenesis is defined as a deficiency of Qi, blood, Yin, and Yang in the body after wound formation, leading to obstruction of the meridians and impaired Qi and blood circulation in the wound area. This prevents the skin and flesh from being nourished and metabolism from being promoted, thus causing the wound repair process to stagnate. Traditional Chinese medicine believes that the pathological essence of CRW is an imbalance of Qi, blood, Yin and Yang. The four major pathological factors of "deficiency", "toxin", "stasis" and "necrosis" are intertwined and mutually causal. When Qi and blood are deficient, there is no source for tissue regeneration; when toxins are retained, local inflammation is aggravated; when blood stasis is obstructed, Qi and blood cannot flow; and when necrotic tissue is not removed, new tissue is difficult to grow. "Removing necrotic tissue and promoting tissue regeneration" is the core treatment principle of TCM for CRW. It is precisely by removing necrotic tissue, clearing stasis, and replenishing Qi and blood that favorable conditions are created for wound repair.

[0003] From a clinical etiological perspective, diabetic foot is the leading cause of cerebral neuropathy (CRW). Due to long-term hyperglycemia, diabetic patients are prone to peripheral neuropathy, vascular disease, and decreased immune function, leading to impaired sensation, insufficient blood supply, and a significantly increased risk of infection in foot wounds. This makes the treatment of diabetic foot-related CRW extremely difficult, resulting not only in low healing rates but also a high risk of serious complications such as amputation, placing a heavy burden on the physical and mental health of patients and the healthcare system.

[0004] Currently, Western medicine treats CRW by "controlling the cause" The core concept is "local repair," and the main treatment methods include three dimensions: First, etiological control, based on hypoglycemic therapy, using oral hypoglycemic drugs, insulin injections, etc., to control blood sugar within a reasonable range and reduce the negative impact of hyperglycemia on wound repair. However, some patients have large fluctuations in blood sugar and difficulty in adjusting hypoglycemic regimens, making it difficult to continuously provide a stable internal environment for wound healing. Second, local debridement, using surgical, ultrasonic, or water jet debridement to remove necrotic tissue, purulent secretions, and foreign bodies from the wound, reducing the source of infection and promoting granulation tissue growth. However, controlling the depth and extent of debridement is difficult; excessive debridement may damage normal tissue, while incomplete debridement can easily lead to infection recurrence and affect the repair effect. Third, the application of new dressings, such as hydrocolloid dressings, foam dressings, and silver ion antibacterial dressings. These dressings can promote healing by maintaining a moist wound environment, releasing antibacterial components, and absorbing exudate. However, some dressings have problems such as high price, high replacement frequency, and limited effectiveness on severely infected wounds, which limits their clinical application. Overall, while existing Western medicine treatments can improve the prognosis of CRW to some extent, they still face problems such as incomplete control of the cause, low efficiency of local repair, and high risk of complications, and there is an urgent need to further optimize treatment plans. Summary of the Invention

[0005] The present invention aims to provide a traditional Chinese medicine composition for wound healing and its preparation method, in order to solve the problems of low repair efficiency and high risk of complications in the treatment of CRW wounds in the prior art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a traditional Chinese medicine composition for wound healing, employing staged treatment, dividing wound healing into early, middle, and late stages. The traditional Chinese medicine composition for early wound healing includes: rhubarb 10-12 parts, coptis 5-6 parts, scutellaria baicalensis 10-12 parts, phellodendron chinense 10-12 parts, corydalis yanhusuo 10-12 parts, notoginseng 6-7 parts, typha pollen 5-6 parts, dragon's blood 4-5 parts, sanguisorba officinalis 10-12 parts, mulberry twig 10-13 parts, and gallnut 10-12 parts; the traditional Chinese medicine composition for middle wound healing includes: astragalus 10-1... 2 parts, Angelica sinensis 10-12 parts, Salvia miltiorrhiza 10-12 parts, Talcum 10-12 parts, Morus alba twig 10-12 parts, Gallnut 10-12 parts, Ligusticum chuanxiong 10-12 parts, Dragon's blood 4-5 parts, Frankincense 10-12 parts, Myrrh 10-12 parts; A traditional Chinese medicine composition for late wound healing includes Astragalus membranaceus 10-12 parts, Dipsacus asper 10-12 parts, Angelica sinensis 10-12 parts, Ligusticum chuanxiong 10-12 parts, Gallnut 10-12 parts, Morus alba twig 10-12 parts, Codonopsis pilosula 10-12 parts, Salvia miltiorrhiza 10-12 parts, Morinda officinalis 10-12 parts, Talcum 10-12 parts.

[0007] Preferably, as an improvement, the mass parts of each raw material in the traditional Chinese medicine composition for early wound healing are: rhubarb 10 parts, coptis 5 parts, scutellaria 10 parts, phellodendron 10 parts, corydalis 10 parts, notoginseng 6 parts, cattail pollen 5 parts, dragon's blood 4 parts, sanguisorba officinalis 10 parts, mulberry twig 10 parts, and gallnut 10 parts; the mass parts of each raw material in the traditional Chinese medicine composition for mid-stage wound healing are: astragalus 10 parts, angelica sinensis 10 parts, salvia miltiorrhiza 10 parts, talc 10 parts, mulberry twig 10 parts, gallnut 10 parts, chuanxiong rhizome 10 parts, dragon's blood 4 parts, frankincense 10 parts, and myrrh 10 parts; the mass parts of each raw material in the traditional Chinese medicine composition for late-stage wound healing are: astragalus 10 parts, dipsacus 10 parts, angelica sinensis 10 parts, chuanxiong rhizome 10 parts, gallnut 10 parts, mulberry twig 10 parts, codonopsis pilosula 10 parts, salvia miltiorrhiza 10 parts, morinda officinalis 10 parts, and talc 10 parts.

[0008] Preferably, as an improvement, the traditional Chinese medicine composition for early wound healing is a powder; the traditional Chinese medicine composition for mid-stage wound healing and the traditional Chinese medicine composition for thick-stage wound healing are both ointments.

[0009] Preferably, as an improvement, a method for preparing a traditional Chinese medicine composition for wound healing is characterized by comprising the following steps:

[0010] Step 1: Crush, extract, and evaporate the raw materials of the traditional Chinese medicine composition for early wound healing to obtain medicinal powder;

[0011] Step 2: The raw materials of the traditional Chinese medicine composition used for mid- and late-stage wound healing are crushed, extracted, and evaporated to obtain medicinal powder, which is then prepared into a paste.

[0012] Preferably, as an improvement, in step one, the extraction stage uses 75% ethanol for extraction.

[0013] Preferably, as an improvement, in step two, the extraction stage uses 75% ethanol for extraction.

[0014] Preferably, as an improvement, when preparing the medicinal powder into a paste, sesame oil is added to the medicinal powder, and the sesame oil is sterilized at high temperature before use.

[0015] Preferably, as an improvement, in step one, the extraction conditions are: extraction temperature 25-35℃, extraction time 1h, and material-to-liquid ratio 33%.

[0016] Preferably, as an improvement, in step two, the extraction conditions are: extraction temperature 25-35℃, extraction time 1.5h, and material-to-liquid ratio 33%.

[0017] The principle and advantages of this solution are as follows: In practical application, this technical solution addresses the problems existing in the treatment of chronic refractory wounds (CRW) using traditional Chinese medicine's theory of "deficiency, toxin, stasis, and putrefaction," combined with the modern TIME principle of wound healing (Tissue Management, Infection / Inflammation, Moisture Balance, and Edge Advancement). Through "staged diagnosis and precise medication," it achieves highly efficient repair of CRW. Based on thorough local diagnosis and treatment of CRW, the wound treatment is divided into three stages:

[0018] Early stage (TI stage): targeting necrotic tissue (T) and infection (I), inflammation is quickly controlled and necrotic tissue is cleared by clearing heat and detoxifying drugs (such as rhubarb and coptis);

[0019] Mid-term (M stage): Targeting moisture balance (M) and granulation tissue growth (T), improve microcirculation and promote granulation tissue formation through blood-activating and qi-tonifying herbs (such as Panax notoginseng and Codonopsis pilosula);

[0020] Later stage (E stage): For wound edge closure (E), qi-tonifying and blood-nourishing herbs (such as astragalus and angelica) are used to accelerate epithelialization, achieving precise treatment through "dynamic adaptation"; and the herbal compositions for each stage of treatment are specifically optimized.

[0021] In the early stage of wound treatment (TI), after basic treatment such as local debridement, a first-stage traditional Chinese medicine powder containing rhubarb, coptis, scutellaria, and phellodendron was applied externally to the wound to promote detoxification, blood circulation, and tissue regeneration. This approach aimed to clear heat and detoxify, reduce swelling and stop bleeding, thus promoting the elimination of necrotic and infected tissue and laying the foundation for wound proliferation and remodeling. By measuring plasma inflammatory factor indicators (TNF-α, IL-6, IL-10) before and after treatment, it was found that inflammatory factors significantly decreased after 3 weeks of treatment (P<0.05), and the decrease was very significant after 6 weeks (P<0.01); in the control group, significant decreases only occurred after 6 weeks of treatment (P<0.05). This demonstrates that the first-stage application of the detoxification, blood circulation, and tissue regeneration traditional Chinese medicine powder effectively controls local inflammation, achieving the effects of clearing heat and detoxifying, reducing swelling and stopping bleeding, and promoting the elimination of necrotic and infected tissue. While CRW inflammation control is crucial, maintaining wound moisture balance and improving local microcirculation are also key aspects of treatment in the intermediate M stage. Building upon the initial treatment of clearing heat and detoxifying, the authors used Panax notoginseng, dragon's blood, Salvia miltiorrhiza, and Codonopsis pilosula. These herbs were ground into a fine powder according to a specific ratio, quenched with 75% alcohol, evaporated, and then mixed with a suitable amount of sesame oil to form a paste. An appropriate amount was applied to the wound to promote local blood circulation, remove blood stasis, nourish qi and blood, and promote granulation tissue growth. In the experimental group, EGF, TGF-β, and VEGF levels significantly increased after 3 weeks of treatment, and the increase was very significant after 6 weeks. In the control group, significant increases were only observed after 6 weeks of treatment, and wound blood supply was also significantly improved. The results indicate that the detoxifying, blood-activating, and tissue-regenerating powder effectively improves local blood supply and promotes granulation tissue growth. In the late stage E, promoting the convergence of the wound edges is precisely the period for TCM to replenish qi and blood, and promote tissue regeneration. During this stage, the granulation tissue of the wound grows well. The author used Astragalus membranaceus, Dipsacus asper, Angelica sinensis, Ligusticum chuanxiong, Gallnut, Codonopsis pilosula, and Morus alba branches, etc., and prepared them into a paste by mixing the above Chinese medicines into a fine powder in proportion. The paste was then applied to the affected area to replenish qi and blood, promote tissue regeneration, and promote early wound healing.

[0022] During the technology research and development stage, the combination of different proportions of traditional Chinese medicine in different stages and the preparation method of traditional Chinese medicine formulas for each stage were among the difficulties and key points in the research and development of this technical solution. The inventor once tried to treat the wound with the same traditional Chinese medicine formula (formula name: Detoxification and Blood-Generating Powder (Ointment) Composition: 10 parts rhubarb, 5 parts coptis, 10 parts scutellaria, 10 parts phellodendron, 10 parts astragalus, 10 parts frankincense, 10 parts myrrh, 10 parts angelica, 10 parts salvia miltiorrhiza, 10 parts chuanxiong, 6 parts notoginseng, 4 parts dragon's blood, 5 parts cattail pollen, 10 parts burnet root, 10 parts corydalis, 10 parts talc, 10 parts dipsacus, 10 parts morinda root, 10 parts gallnut, 10 parts mulberry twig) based solely on the observation of granulation tissue on the wound. However, the results showed that it could not achieve the desired and accurate treatment, and its efficacy was poor. To address this, the research team, based on thorough local diagnosis and treatment of chronic refractory wounds (CRW), divided wound treatment into three stages (early, middle, and late), using different traditional Chinese medicine (TCM) formulas for each stage. Furthermore, the preparation stage after formula determination also faced certain technical challenges: for resinous medicinal materials, such as frankincense and myrrh, prolonged high-temperature drying time was problematic as they tended to stick and were difficult to pulverize. The research team optimized the preparation process, first using a small pulverizer for pulverization, then co-pulverizing with other drugs using a large grinder, and finally selecting the required fineness for preparation. The sterilization of sesame oil used in the middle and late stages was also developed, continuously improving sterilization quality. Finally, a base sesame oil was selected, boiled, and then bottled under ultraviolet light before filling to ensure the base sesame oil was sterilized before use. The initial intention of this technical solution was to accelerate wound healing; however, results from the application of TCM powder in the middle and late stages showed that the TCM preparation of this solution, while promoting wound healing, also made the surrounding tissue smooth and rosy, exhibiting a certain cosmetic effect.

[0023] In summary, the beneficial effects of this technical solution are as follows:

[0024] 1. This technical solution innovates the treatment approach, breaks through the "single drug" approach, and achieves "staged precision treatment". It removes necrotic tissue in the early stage, removes blood stasis in the middle stage, and replenishes deficiency in the later stage, avoiding the "use of tonifying drugs to promote toxicity in the early stage and use of detoxifying drugs to harm the body's vital energy in the later stage".

[0025] 2. This technical solution achieves both symptomatic and root-cause treatment through innovative formulation of medicinal materials, focusing on the "core pathology".

[0026] 3. This technical solution innovatively combines the dosage forms of the composition. The early powder form can avoid the ointment form from hindering the drainage of necrotic tissue, which is suitable for wounds that "need drainage and observation". The mid-to-late stage ointment form conforms to the concept of "moist healing", providing long-lasting drug delivery and protecting new granulation tissue. Attached Figure Description

[0027] Figure 1 These are comparative images of animal experiments taken in the embodiments of the present invention.

[0028] Figure 2 This is a comparison chart of animal experiment results in the embodiments of the present invention. Detailed Implementation

[0029] The following detailed description provides further details on specific embodiments, but the embodiments of the present invention are not limited thereto. Unless otherwise specified, the technical means used in the following embodiments are conventional means well known to those skilled in the art; the experimental methods used are all conventional methods; and the materials and reagents used are all commercially available.

[0030] Overview of the plan:

[0031] A traditional Chinese medicine composition for wound healing employs staged treatment, classifying wound healing into early, middle, and late stages. The composition for early wound healing includes: rhubarb 10-12 parts, coptis 5-6 parts, scutellaria baicalensis 10-12 parts, phellodendron chinense 10-12 parts, corydalis yanhusuo 10-12 parts, notoginseng 6-7 parts, typha pollen 5-6 parts, dragon's blood 4-5 parts, sanguisorba officinalis 10-12 parts, mulberry twig 10-13 parts, and gallnut 10-12 parts. The composition for middle-stage wound healing includes: astragalus membranaceus 10-12 parts and angelica sinensis 10-12 parts. The following are traditional Chinese medicine compositions for wound healing: 10-12 parts of Astragalus membranaceus, 10-12 parts of Dipsacus asper, 10-12 parts of Angelica sinensis, 10-12 parts of Ligusticum chuanxiong, 4-5 parts of Dragon's Blood, 10-12 parts of Frankincense, and 10-12 parts of Myrrh; 10-12 parts of Codonopsis pilosula, 10-12 parts of Salvia miltiorrhiza, 10-12 parts of Morinda officinalis, and 10-12 parts of Talc.

[0032] A method for preparing a traditional Chinese medicine composition for wound healing, characterized by comprising the following steps:

[0033] Step 1: Crush the raw materials of the traditional Chinese medicine composition for early wound healing, extract with 75% ethanol, and evaporate to obtain medicinal powder;

[0034] Step 2: Crush the raw materials of the traditional Chinese medicine composition for mid- and late-stage wound healing, extract with 75% ethanol, evaporate to obtain medicinal powder, and then add high-temperature sterilized sesame oil to make the medicinal powder into a paste.

[0035] Example 1

[0036] In this embodiment, the traditional Chinese medicine composition for early wound healing includes: 10 parts rhubarb, 5 parts coptis, 10 parts scutellaria, 10 parts phellodendron, 10 parts corydalis, 6 parts notoginseng, 5 parts cattail pollen, 4 parts dragon's blood, 10 parts sanguisorba officinalis, 10 parts mulberry twig, and 10 parts gallnut; the traditional Chinese medicine composition for mid-stage wound healing includes: 10 parts astragalus, 10 parts angelica sinensis, 10 parts salvia miltiorrhiza, 10 parts talc, 10 parts mulberry twig, 10 parts gallnut, 10 parts chuanxiong, 4 parts dragon's blood, 10 parts frankincense, and 10 parts myrrh; the traditional Chinese medicine composition for late-stage wound healing includes: 10 parts astragalus, 10 parts dipsacus, 10 parts angelica sinensis, 10 parts chuanxiong, 10 parts gallnut, 10 parts mulberry twig, 10 parts codonopsis, 10 parts salvia miltiorrhiza, 10 parts morinda officinalis, and 10 parts talc.

[0037] Experiment Example 1 Effect Verification

[0038] Experimental subjects: wounds with an area of ​​1-36 cm² 2 Inclusion criteria: age 18-75 years and capable of independent behavior; good blood supply to the ulcer upon clinical assessment, with an ABI ≥ 0.6 for foot ulcers; not using immunosuppressants, or the dosage of immunosuppressants used has remained unchanged recently; informed consent and voluntary signing of the informed consent form; underlying conditions such as hypertension and diabetes maintained within a controllable range (blood pressure ≤ 140 / 90 mmHg (1 mmHg ≈ 0.133 kPa), fasting blood glucose < 7.00 mmol / L); according to Xi Jiuyi's TCM syndrome differentiation, the syndrome belongs to "damp-heat toxicity, tendon and flesh rot". Exclusion criteria: breastfeeding or pregnant women; those with allergies or allergies to the study drug or any of its components; those with diabetic ketoacidosis or nonketotic hyperosmolar coma; those with ulcers caused by malignant tumors; those with serious cardiovascular, cerebrovascular, hepatic, renal, endocrine or hematopoietic system diseases or mental illnesses; those currently undergoing other drug clinical trials or treatment for other diseases.

[0039] Patients with CRW (congenital cerebral ulceration) who were treated at the outpatient or inpatient department of Yubei District Traditional Chinese Medicine Hospital were included in this study. They were randomly divided into a control group and an observation group, with 41 patients in each group. There were no statistically significant differences in clinical data such as gender, age, etiology, and wound condition between the two groups (P > 0.05). This study was approved by the Ethics Committee of Yubei District Traditional Chinese Medicine Hospital, Chongqing Municipality, under the number Ybqzyy2023-25.

[0040] Experimental Methods: Both groups (control group and experimental group) received basic treatment: control of blood glucose and blood pressure, improvement of microcirculation, and selection of appropriate antibiotics for anti-infection treatment based on the results of bacteriological culture and drug sensitivity testing of wound secretions. Nutritional support was provided to malnourished patients. Wound debridement was performed to remove necrotic tissue.

[0041] The control group received basic treatment and local debridement followed by dressing changes with povidone-iodine gauze.

[0042] The experimental group received detoxification, blood-activating, and tissue-regenerating therapy in addition to the treatment given to the control group. Based on the TIME principle of wound bed preparation, CRW wounds were divided into early, middle, and late stages. The TI (Necrosis and Infection) stage, i.e., the early stage of treatment (debridement and detoxification stage): On the basis of local debridement, rhubarb, coptis, scutellaria, and phellodendron were used. The above Chinese medicines were ground into a fine powder according to the proportion, quenched with 75% alcohol, evaporated, dried, and bottled for later use. When needed, the powder was applied to the wound to clear heat and detoxify, reduce swelling and stop bleeding, so as to promote the removal of necrotic tissue and inflammatory exudate, and lay the foundation for wound proliferation and remodeling. The M (Moisture Balance) stage, also known as the mid-treatment stage (blood-activating and stasis-removing stage), builds upon the heat-clearing and detoxifying approach used in the early stage. This stage utilizes herbs such as Panax notoginseng, dragon's blood, Salvia miltiorrhiza, and Codonopsis pilosula. These herbs are ground into a fine powder according to a specific ratio, extracted with 75% alcohol, evaporated, and then mixed with a suitable amount of sesame oil to form a paste. An appropriate amount is applied to the wound to promote local blood circulation, remove blood stasis, nourish qi and blood, and promote granulation tissue growth. The E (Epidermalization) stage, also known as the late-treatment stage (astringent and tissue-regenerating stage), focuses on tonifying qi and blood, astringing and promoting tissue regeneration. This stage uses herbs such as Astragalus membranaceus, Dipsacus asper, Angelica sinensis, Ligusticum chuanxiong, Galla chinensis, and Morus alba. These herbs are ground into a fine powder according to a specific ratio, extracted with 75% alcohol, evaporated, and then mixed with a suitable amount of sesame oil to form a paste. An appropriate amount is applied to the wound to tonify qi and blood, astringe and promote tissue regeneration, and promote early wound healing. Both groups require daily dressing changes.

[0043] Observation indicators:

[0044] 1) Wound healing rate: The wound area was photographed with a digital camera and calculated using graphics software. Wound healing rate = (Ulcer area before treatment - Residual ulcer area after treatment) ÷ Ulcer area before treatment × 100%.

[0045] 2) Pain level assessment: The Visual Analogue Scale (VAS) was used for assessment, and the higher the score, the more severe the pain.

[0046] 3) Plasma inflammatory factors: The levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10) in patients were collected and measured before treatment, 3 weeks after treatment, and 6 weeks after treatment.

[0047] 4) Tissue growth factors: Epidermal growth factor (EGF), transforming growth factor-β (TGF-β), and vascular endothelial growth factor (VEGF) levels were collected and measured before treatment, 3 weeks after treatment, and 6 weeks after treatment.

[0048] 5) Local blood supply detection: Transcutaneous oxygen partial pressure and laser Doppler measurement were used to quantitatively analyze changes in wound blood supply before and after treatment.

[0049] Therapeutic criteria:

[0050] The evaluation criteria were determined with reference to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases". Cure: The patient's wound has completely healed, and edema, wound area, and wound exudate have essentially disappeared.

[0051] Significant effect: wound size reduced by ≥70%, and clinical symptoms significantly alleviated.

[0052] Effective: Wound size reduced by ≥40% or <70%, clinical symptoms alleviated.

[0053] Ineffective: Wound shrinkage <40%, no significant relief of clinical symptoms.

[0054] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) ÷ Total number of cases × 100%

[0055] 1.1 The results of wound healing rate are shown in Table 1. The results show that the experimental group adopted a staged treatment strategy, and the ulcer area was significantly reduced after three weeks of treatment compared with the control group. The wound healing rate was as high as 93.72%, which was significantly higher than 62.33% of the control group.

[0056] Table 1 Wound healing rates in the two groups

[0057]

[0058] 2.1 Inflammation-related detection indicators: The results are shown in Table 2. The results show that the inflammatory factors in the experimental group of this invention, which adopted a staged treatment strategy, were significantly reduced after 3 weeks of treatment (P<0.05), and the reduction was very significant after 6 weeks of treatment (P<0.01); the control group only showed a significant reduction after 6 weeks of treatment (P<0.05).

[0059] Table 2 Comparison of inflammatory factors between the two groups

[0060]

[0061] 3.1 Tissue growth factors: The results are shown in Table 3. The results showed that EGF, TGF-β and VEGF in the experimental group increased significantly 3 weeks after treatment and increased significantly 6 weeks after treatment; while in the control group, they only increased significantly 6 weeks after treatment and the blood supply to the wound was also significantly improved.

[0062] Table 3 Comparison of tissue growth factors between the two groups

[0063]

[0064] Experiment Example 2: Animal Experiment

[0065] Experimental methods: The team previously conducted basic research on the detoxification, blood circulation and muscle regeneration method in the CRW animal model. The experimental group used the detoxification and blood circulation and muscle regeneration method for intervention research (the composition formula in Example 1), while the control group used conventional iodine solution for dressing.

[0066] Experimental results: such as Figure 1 As shown, the wound area gradually decreased in both groups as healing time increased. Debridement and hemostasis are the first stages of wound healing. Compared to the control group (PBS treatment), applying the traditional Chinese medicine preparation used in the detoxification, blood-activating, and tissue-regenerating method to the wound showed effective hemostasis and reduced inflammatory exudate, with similarly significant effects during the proliferative phase (3-14 days). The difference in wound healing was even greater after 3 days; on day 7, as cytokines increased, the wound area in the detoxification, blood-activating, and tissue-regenerating method group was smaller than that in the control group. The difference gradually decreased on day 10, and after 14 days, the detoxification, blood-activating, and tissue-regenerating method group was almost completely healed, while the wound area in the control group remained approximately 5% of its initial size. The wound contraction rate between the two groups was compared (…). Figure 2 The values ​​in the detoxification, blood circulation and tissue regeneration group were always higher than those in the control group.

[0067] The above descriptions are merely embodiments of the present invention, and common knowledge such as specific technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A traditional Chinese medicine composition for wound healing, characterized in that: Staged treatment was adopted, dividing wound healing into early, middle, and late stages. The traditional Chinese medicine composition used for early wound healing was: rhubarb 10-12 parts, coptis 5-6 parts, scutellaria baicalensis 10-12 parts, phellodendron chinense 10-12 parts, corydalis yanhusuo 10-12 parts, notoginseng 6-7 parts, typha pollen 5-6 parts, dragon's blood 4-5 parts, sanguisorba officinalis 10-12 parts, mulberry twig 10-13 parts, and gallnut 10-12 parts. The traditional Chinese medicine composition used for middle wound healing was: astragalus membranaceus 10-12 parts, angelica sinensis 10-12 parts, salvia miltiorrhiza 10-12 parts, and talc 10-1... 2 parts of mulberry twigs, 10-12 parts of gallnut, 10-12 parts of chuanxiong rhizome, 4-5 parts of dragon's blood, 10-12 parts of frankincense, and 10-12 parts of myrrh; the traditional Chinese medicine composition for late-stage wound healing is: 10-12 parts of astragalus root, 10-12 parts of dipsacus root, 10-12 parts of angelica root, 10-12 parts of chuanxiong rhizome, 10-12 parts of gallnut, 10-12 parts of mulberry twigs, 10-12 parts of codonopsis root, 10-12 parts of salvia root, 10-12 parts of morinda root, and 10-12 parts of talc; the preparation method of the composition includes the following steps: Step 1: Crush, extract, and evaporate the raw materials of the traditional Chinese medicine composition for early wound healing to obtain medicinal powder; the extraction conditions are: extraction temperature 25-35℃, extraction time 1 hour, and material-to-liquid ratio 33%; Step 2: The raw materials of the traditional Chinese medicine composition for mid- and late-stage wound healing are crushed, extracted, and evaporated to obtain medicinal powder, which is then prepared into a paste. The extraction conditions are: extraction temperature 25-35℃, extraction time 1 hour, and material-to-liquid ratio 33%.

2. The traditional Chinese medicine composition for wound healing according to claim 1, characterized in that: The mass proportions of each raw material in the traditional Chinese medicine composition for early wound healing are as follows: rhubarb 10 parts, coptis 5 parts, scutellaria 10 parts, phellodendron 10 parts, corydalis 10 parts, notoginseng 6 parts, cattail pollen 5 parts, dragon's blood 4 parts, sanguisorba officinalis 10 parts, mulberry twig 10 parts, and gallnut 10 parts. The mass proportions of each raw material in the traditional Chinese medicine composition for mid-stage wound healing are as follows: astragalus 10 parts, angelica sinensis 10 parts, salvia miltiorrhiza 10 parts, talc 10 parts, mulberry twig 10 parts, gallnut 10 parts, chuanxiong rhizome 10 parts, dragon's blood 4 parts, frankincense 10 parts, and myrrh 10 parts. The mass proportions of each raw material in the traditional Chinese medicine composition for late-stage wound healing are as follows: astragalus 10 parts, dipsacus 10 parts, angelica sinensis 10 parts, chuanxiong rhizome 10 parts, gallnut 10 parts, mulberry twig 10 parts, codonopsis pilosula 10 parts, salvia miltiorrhiza 10 parts, morinda officinalis 10 parts, and talc 10 parts.

3. The traditional Chinese medicine composition for wound healing according to claim 2, characterized in that: The traditional Chinese medicine composition for early wound healing is in powder form; the traditional Chinese medicine composition for mid-stage wound healing and the traditional Chinese medicine composition for late-stage wound healing are both in ointment form.

4. The traditional Chinese medicine composition for wound healing according to claim 3, characterized in that: In step one, the extraction stage uses 75% ethanol for extraction.

5. A traditional Chinese medicine composition for wound healing according to claim 4, characterized in that: In step two, the extraction stage uses 75% ethanol for extraction.

6. A traditional Chinese medicine composition for wound healing according to claim 5, characterized in that: When preparing the medicinal powder into a paste, sesame oil is added to the powder. The sesame oil is sterilized at high temperature before use.

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