Regulation and application type traditional Chinese medicine ointment for tumor refractory ulcer and preparation method of regulation and application type traditional Chinese medicine ointment

Abstract

The invention relates to a blending and applying type traditional Chinese medicine ointment for tumor refractory ulcer and a preparation method thereof. In the embodiment of the invention, the traditional Chinese medicine ointment (traditional Chinese medicine decoction mixed application type) can be used for remarkably improving refractory ulcers of tumor patients caused by tumors, treated or combined diseases and the like. The traditional Chinese medicine ointment is composed of three basic prescriptions and modified prescriptions, is simple to prepare, convenient to store and remarkable in clinical curative effect, and the traditional Chinese medicines are repeatedly utilized, so that effective traditional Chinese medicine components can be maximally used, and the treatment cost is reduced. The traditional Chinese medicine liquid can be used for cleaning wounds and blending and applying ointment, and due to the fact that tumor patients have many disease changes and complex illness conditions, in the treatment process, medicine use can be adjusted at any time according to the guidance of the basic theory of traditional Chinese medicine, and medicine use is more flexible and convenient. For some patients, the bottleneck that no effective treatment means exist in the advanced stage of tumors can be broken through, the life quality of the patients can be improved to the maximum extent, and the medicine has development prospects and important social benefits and economic benefits.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medicine, more particularly relates to a Tiaofu type traditional Chinese medicine ointment for tumor refractory ulcer and a preparation method thereof. The Tiaofu type traditional Chinese medicine ointment is especially suitable for refractory ulcer combined with post-chemotherapy or advanced tumor patients. BACKGROUND

[0002] Tumor-induced refractory ulcer is a common complication in patients with tumors, which is caused by tumor invasion, treatment side effects, or low immunity. The ulcer wound does not heal for a long time, and is even accompanied by infection and pain. The following are the common types and characteristics: (1) Ulcer caused by direct invasion or compression of tumor: Breakdown of skin cancer (such as squamous cell carcinoma, basal cell carcinoma), breast cancer, malignant melanoma, and other superficial or near-surface tumors. Clinically, the tumor tissue grows rapidly, the center is necrotic and broken due to ischemia, forming an irregular ulcer, with a raised edge, hard quality, and uneven base, often accompanied by bloody or purulent secretions, easy to bleed and pain. (2) Obstructive ulcer of cavity tumor: such as esophageal cancer, gastric cancer, colorectal cancer, etc. After the tumor blocks the lumen, the local tissue is ischemic and infected, forming an ulcer. Intraluminal ulcers (such as esophageal ulcers, gastric ulcers) can be accompanied by dysphagia, hematemesis, and hematochezia. Due to stenosis or obstruction of the lumen, drugs are difficult to reach, and healing is difficult. (3) Tumor treatment-related refractory ulcer: radiation-induced ulcer after radiotherapy: common in patients with head and neck cancer, breast cancer, pelvic tumors, etc. receiving radiotherapy. The skin or mucosa in the radiotherapy area is broken due to radiation damage, with pale wound, fibrosis at the edge, and severe pain, long healing period, and easy to secondary infection (due to local immune suppression by radiotherapy). (4) Skin and mucosa ulcer after chemotherapy: Chemotherapy drugs (such as paclitaxel, fluorouracil) cause skin and mucosa damage, or cause ulcer due to bone marrow suppression and low immunity. Shallow ulcers often occur in the oral cavity, perianal mucosa, and other mucosa sites, accompanied by pain and difficulty eating, and severe fungal infection. (5) Complication ulcer in advanced tumor. (6) Malnutrition ulcer: Patients with advanced tumors suffer from chronic consumption, cachexia, protein and nutrient deficiency, leading to decreased skin and mucosa repair capacity. It often occurs in pressure areas (such as sacrococcygeal, heel), similar to bedsores, with edema, pale granulation, and low proteinemia and anemia. Simple dressing is difficult to heal. (7) Cancer neuropathic ulcer: Tumor invasion or local blood circulation disorder leads to decreased skin sensation, insufficient blood supply, and easy repeated injury to form an ulcer. The ulcer does not heal for a long time, with numbness, tingling, or paresthesia, poor local blood supply, and obvious pain during dressing. Although Western medicine treats tumor refractory ulcer with local treatment, systemic support, and etiological intervention as the core, it has significant limitations, and it is difficult to completely reverse the fundamental causes of tumor invasion, cachexia, and low immunity, leading to a "weak foundation" for wound repair. Local treatment is contradictory, debridement can cause bleeding or tumor residue, long-term anti-infection can cause drug resistance, and growth factors and other healing-promoting methods are limited in the abnormal microenvironment of tumors, especially for ischemic fibrotic wounds of radiation ulcers and repeated damage of chemotherapy mucosa ulcers. Symptoms management and quality of life improvement are insufficient, and severe pain is difficult to completely control. The overall efficacy is restricted by multiple factors.

[0003] Tumor refractory ulcer is a chronic wound caused by local tissue ischemia and necrosis, low immune function, infection and other reasons in tumor patients, which has the pathological characteristics of "deficiency, blood stasis and toxin" coexistence: the deficiency of vital qi leads to the long non-healing of the wound, blood stasis leads to poor local blood supply, and the accumulation of heat and toxin leads to difficult infection control. In the existing treatment, the debridement and antibiotics of western medicine can easily cause drug resistance, and cannot improve the general deficiency state; the external use of traditional Chinese medicine drugs is mostly single formula, which is difficult to meet the multiple needs of "tonifying deficiency, removing blood stasis and detoxifying", and the curative effect is limited. Therefore, it has important clinical value to develop a traditional Chinese medicine ointment based on multi- syndrome type cooperation and flexible deployment, which can accurately intervene the complex pathogenesis of tumor ulcer. SUMMARY

[0004] In view of the above problems, the present application provides a kind of for tumor refractory ulcer's regulating and applying type traditional Chinese medicine ointment and its manufacturing method. Western medicine treatment of tumor refractory ulcer, because the patient's condition is various, cannot be effectively handled, it is difficult to completely reverse the root causes such as tumor invasion, cachexia and low immunity, debridement can easily cause bleeding or tumor residue, long-term anti-infection can easily cause drug resistance, the effect of repeated damage to radioactive ulcer and chemotherapy mucosa ulcer is not good, the improvement of symptoms management and life quality is insufficient, severe pain is difficult to completely control, high frequency of dressing change and ulcer related discomfort can easily cause patients' physical and mental stress, and patients often have difficulty in adhering to the whole treatment due to multiple organ dysfunction, the overall curative effect is restricted by multiple factors. The pathogenesis of tumor ulcer "toxicity, blood stasis and deficiency" is the generalization of the core pathological changes of tumor development to ulcer stage by traditional Chinese medicine, and the three are interwoven and cause and effect, which together lead to ulcer healing and lingering illness. The present application is guided by the basic theory of traditional Chinese medicine, and the invented traditional Chinese medicine ointment can be used more flexibly to solve the above problems.

[0005] One of the objectives of this invention is to address the pathogenesis of refractory tumor ulcers characterized by the coexistence of "deficiency, blood stasis, and toxicity" by providing a traditional Chinese medicine ointment with three basic formulas and combinations of modified formulas. Through the application of the basic formulas alone or in combination, and by adjusting the formulas according to symptoms, the invention achieves single or synergistic effects of "tonifying qi and promoting tissue regeneration, resolving blood stasis and relieving pain, and clearing heat and detoxifying," thereby promoting ulcer healing, reducing pain, and lowering the risk of infection. A traditional Chinese medicine ointment for promoting wound healing, tissue regeneration, and relieving pain is provided, with the following ingredients: Basic Formulas (3 types): F1 Heat-Clearing and Detoxifying Formula: Honeysuckle 20 parts, Dandelion 15 parts, Sophora flavescens 12 parts, Viola yedoensis 15 parts, Forsythia suspensa 18 parts. Efficacy: This formula mainly clears heat and detoxifies, dries dampness, and is suitable for symptoms caused by heat toxicity or damp heat, such as sores, carbuncles, and red, swollen, hot, and painful skin. F2 Blood-Activating and Blood-Stasis-Resolving Formula: Angelica sinensis 18 parts, Paeonia lactiflora 12 parts, Frankincense 8 parts, Myrrh 8 parts. Efficacy: Primarily functions to invigorate blood circulation, remove blood stasis, and relieve pain. It can be used for pain and swelling caused by blood stasis, or for lingering blood stasis after external injury. F3 Tonifying and Muscle-Generating Formula: Astragalus membranaceus 25 parts, Angelica dahurica 10 parts, Dragon's Blood 10 parts, Spatholobus suberectus 20 parts. Efficacy: Has the effects of tonifying qi and nourishing deficiency, invigorating blood circulation and promoting muscle regeneration. Suitable for conditions such as physical weakness, slow-healing sores, and slow muscle growth. Modifications: For excessive exudation, add Phellodendron chinense 10g, Sophora flavescens 10g, and Portulaca oleracea 15g (to enhance the effects of clearing heat, drying dampness, and astringing). For excessive necrotic tissue, add Smilax glabra 20g (to strengthen detoxification and dampness removal, helping to remove necrotic tissue). For slow granulation tissue growth, add Astragalus membranaceus 20g, Codonopsis pilosula 15g, and Codonopsis pilosula 15g (to enhance qi and nourish deficiency, promoting granulation tissue growth). For dryness, peeling, and itching, add Rehmannia glutinosa 15g, Scrophularia ningpoensis 15g, and Ophiopogon japonicus 15g. (Nourishes Yin and moistens dryness, relieves dryness and itching). For itching, add 15g of Phellodendron bark, 15g of Kochia scoparia fruit, and 15g of Dictamnus dasycarpus root bark. (Clears heat and dries dampness, dispels wind and relieves itching). Excipients: Vaseline and beeswax.

[0006] The second object of the present application The traditional Chinese medicine ointment formula is composed of three basic prescriptions and one modified prescription. The most suitable basic prescription is used as the main prescription for the ulcer of the tumor patient, and the modified prescription is used as the auxiliary. The prescription is used according to the disease, and the drug is used according to the symptoms. The drug effect is faster than that of the traditional Chinese medicine ointment, the drug dose is easier to control, and the clinical treatment effect is better. In the treatment process, the drug can be adjusted according to the condition at any time, breaking the limitation of the traditional ointment. The use of it needs to analyze the TCM etiology of the patient's ulcer, and the drug is used according to the symptoms and stages, so as to achieve the purpose of curing the disease. For the patient, compared with the long treatment time and high cost of western medicine, the present application has the advantages of short treatment course, quick effect, no recurrence after recovery, low cost and no side effects, and is worthy of wide application and promotion to benefit the tumor patients. Through the judgment of the basic TCM syndrome type of "toxicity, deficiency and blood stasis", the basic prescription is used for treatment, which can achieve significant clinical effect. Because part of the tumor patients will be accompanied by other western medicine treatment in the treatment process, such as radiotherapy, chemotherapy, targeted drugs, immunity, surgery and other tumor treatment methods, if the patient's condition changes during the use process, the modified prescription can be used to adjust the treatment in time, so as to achieve the effect of treating the symptoms and the root cause. With the recognition of traditional Chinese medicine, the application of the present application will also be accepted and used by more patients.

[0007] The third object of the present application is a dressing type traditional Chinese medicine ointment for tumor refractory ulcer and its preparation method, which is characterized by the following specific steps: (1) pretreatment of medicinal materials: select the base formula and wash it; (2) extraction of effective components: take the medicinal materials of the base formula, add 8-10 times the amount of water, soak for 50 minutes, put into a pot, simmer for 30 minutes on low heat, filter to obtain medicinal liquid; add water to the medicinal residue and simmer for 20 minutes, filter to obtain medicinal liquid, combine the two medicinal liquids, if necessary, retain an appropriate amount of medicinal liquid for patients who need to take orally or rinse the wound, and concentrate the remaining medicinal liquid on low heat until it is thick (about 50-60 ml), so as to facilitate the control of the thickness during dressing, and let it cool down for standby use (decoction needs to be decocted immediately, and is stored in cold storage for no more than 24 hours); let it cool down for standby use. If a modified formula of traditional Chinese medicine is used, the medicinal materials are treated in the same way. Dressing of the ointment: preparation of the ointment body of traditional Chinese medicine (base ointment), extraction of ointment body medicinal materials: simmer the remaining medicinal residue, dry or dry it, cut it into pieces and powder it; grind them into fine powder respectively, pass them through an 8# sieve with 150 meshes, and standby use (reduce the particle feeling of the ointment body, and avoid the stimulation of particles to the wound); melt the base: put vaseline and beeswax into a clean pot, heat it with water bath (water bath temperature is 60-70℃), stir until it is completely melted, keep it slightly warm for standby use; mixing and preparation of the ointment: slowly add the traditional Chinese medicine powder into the melted base, stir until it is uniform and delicate, continue to stir until the temperature of the ointment body decreases to about 40℃ after the fire is turned off, so as to avoid the loss of efficacy of the powder due to high temperature; after the ointment body slightly solidifies, store it in sterile jars, seal and store in cold storage (validity period is 1 month); (4) storage: store the ointment in sterile jars, seal and store in a cool and dry place (or in cold storage), avoid contamination, and the shelf life is about 1 month; (5) operation steps of decoction dressing: pretreatment of the wound: rinse the ulcer surface with normal saline or the above-mentioned traditional Chinese medicine decoction (before concentration), gently remove necrotic tissue and secretions (avoid violent wiping); dressing of the ointment body: take 5-10 g of traditional Chinese medicine ointment body (adjust according to the size of the wound), add 2-5 ml of concentrated traditional Chinese medicine decoction, stir until it is paste-like (the thickness is appropriate to be "not dripping, easy to spread"); dressing method: evenly spread the prepared paste-like ointment on the wound surface with a sterile cotton swab, the thickness is about 1-2 mm, cover the edge of the wound surface by 0.5 cm, then cover and bandage it with sterile gauze, change the dressing 1-2 times a day; (1) clean the wound before use (use normal saline or traditional Chinese medicine lotion to gently rinse, remove pus and necrotic tissue); (2) take an appropriate amount of ointment and evenly spread it on sterile gauze, cover the wound, change the dressing 1 time a day or every other day, adjust the frequency according to the exudation of the wound (3) sterile requirement: keep the container and tool clean during preparation, the powdered medicinal materials can be sterilized by ultraviolet light for 30 minutes to avoid contamination of the ointment body; (4) if allergic or irritating reactions such as local swelling, itching, pain aggravation occur after use, stop using immediately and consult a doctor; (5) this ointment is only an auxiliary treatment method, which needs to be combined with the treatment of the primary disease and wound care, and cannot replace the standard anti-tumor treatment.This method has the dual effects of "paster drug loading + decoction synergism", and takes into account local detoxification and muscle regeneration and overall tonification, and is suitable for conservative treatment of advanced tumor intractable ulcers, and needs to be dynamically adjusted under the guidance of a TCM doctor according to the patient's constitution and sore surface.

[0008] The fourth purpose of the present application provides a core mechanism of a regulating and applying type traditional Chinese medicine ointment for tumor intractable ulcers as follows: promoting wound repair: improving local microcirculation by promoting blood circulation and unblocking collaterals, and promoting granulation tissue growth. Anti-inflammatory and antibacterial: reducing local inflammatory response and inhibiting pathogenic microorganisms by using heat-clearing and detoxifying and drying dampness and astringing sore drugs. Regulating local microenvironment: improving the nutritional status of the ulcer by tonifying qi and nourishing blood and invigorating the spleen and removing dampness, and reducing exudation. The core application target is to improve the microenvironment of the wound by local administration, and to assist in promoting healing and reducing symptoms, which needs to be used in a standard way according to the specific ulcer site, nature and patient's general state. It can be applied to post-radiotherapy radiation ulcers, post-chemotherapy skin and mucous membrane ulcers, advanced tumor complication ulcers, cancer neuropathic ulcers, and reduction of intractable ulcers in elderly tumor patients.

[0009] The pharmacological effects of the present application are as follows: F1 heat-clearing and detoxifying formula: honeysuckle 15g, dandelion 20g, sophora flavescens 15g, purple flower dindin 15g, forsythia 15g. Function: the main effect of this formula is to clear heat and detoxify, dry dampness, and is suitable for heat or dampness caused by disease, such as sore abscess, skin redness, swelling and pain. Honeysuckle: contains chlorogenic acid, luteolin and other components, has broad-spectrum antibacterial (inhibits bacteria, fungi), anti-inflammatory effect, can reduce the local redness, swelling and pain caused by infection in ulcer, at the same time, enhance the phagocytic function of immune cells, clear necrotic tissue. Dandelion: contains dandelion sterol, inulin, etc., can inhibit the release of inflammatory factors (such as TNF-α, IL-6), has antibacterial and antioxidant effects, reduces the inflammatory reaction of ulcer, and promotes the subsidence of inflammation. Sophora flavescens: the main component is sophoramine, has the effects of anti-inflammatory, antibacterial (especially for fungi, anaerobic bacteria), inhibiting excessive immune response, at the same time, can reduce the exudation of ulcer, relieve local damp-heat state. Purple flower dindin: contains flavonoids, can enhance the phagocytic ability of white blood cells, inhibit pathogenic bacteria (such as staphylococcus aureus), and reduce the edema of the tissue around the ulcer by anti-inflammatory to control the spread of infection. Forsythia: contains forsythoside, etc., has antibacterial, antiviral and anti-inflammatory effects, can reduce the level of inflammatory factors in the local ulcer, at the same time, promotes the expression of angiogenesis related factors, lays the foundation for tissue repair. F2 blood-activating and stasis-removing formula: angelica 10g, red peony root 10, myrrh (processed) 6g, frankincense (processed) 6g. Function: mainly activating blood and removing blood stasis, and can be used for pain and swelling caused by blood stasis, or blood stasis after trauma. Angelica: contains ferulic acid, angelica polysaccharide, etc., can inhibit platelet aggregation, improve blood circulation in the local ulcer, increase oxygen and nutrient supply to the tissue, at the same time, promote the absorption of inflammatory exudates, reduce local swelling. Red peony root: contains paeoniflorin, can inhibit thrombin activity, improve microcirculation stasis, reduce blood viscosity, at the same time, protect vascular endothelium by anti-inflammatory and antioxidant effects, reduce the damage to the tissue around the ulcer. Frankincense (processed), myrrh (processed): contains volatile oil, resin and other components, can inhibit inflammatory reaction and relieve pain, at the same time, promote local blood circulation, accelerate the dispersion of blood stasis, create conditions for tissue regeneration (processed can reduce the irritation, enhance the effect of activating blood and relieving pain). F3 tonifying and muscle-regenerating formula: astragalus 20g, baizhi 10g, dragon's blood 6g, kanglei 15g. Function: has the effects of tonifying qi and blood, activating blood and promoting muscle regeneration, and is suitable for physical weakness, sore abscess for a long time, slow muscle growth and other conditions. Astragalus: contains astragalus polysaccharide, astragaloside A, etc., can enhance the immune function of the body (promote the activity of lymphocytes and macrophages), stimulate the proliferation of fibroblasts and the synthesis of collagen, accelerate the growth of granulation tissue, at the same time, improve the microcirculation, provide nutrition for ulcer healing. Baizhi: contains imperatorin, etc., has antibacterial and anti-inflammatory effects, can inhibit local infection in ulcer, at the same time, promote the migration of epithelial cells, accelerate wound coverage, reduce scar formation. Dragon's blood: contains dracorhodin, haematoxylin and other components, can promote platelet aggregation (local hemostasis), at the same time, stimulate capillary neogenesis and granulation tissue proliferation, accelerate the repair of ulcer surface, also has certain antibacterial effect.Caulis Spatholobi: contains spatholobus amarus, etc., can improve local blood circulation, increase tissue blood supply, regulate immune function, promote inflammation subsides and tissue regeneration. Add and subtract: more exudation can add 10g of Huang Bai, 10g of Ku Shen, 15g of Marsdenia. (Enhance the effect of clearing heat and drying dampness, astringency) Huang Bai contains berberine, which can enhance antibacterial, anti-inflammatory and astringent effect, reduce exudation; Marsdenia contains flavonoids, which can inhibit bacteria and promote wound dryness, synergistically control local wet and rotten. More can add 20g of Smilax Glabra. (Strengthen detoxification and dampness, help remove the rotten meat) contains smilax glycosides, has anti-inflammatory, antibacterial (especially for deep infection) and promotes necrotic tissue shedding effect, helps "rotten". Slow growth of granulation can add 20g of Astragalus, 15g of Taizishen, 15g of Dangshen. (Enhance qi and invigorate the body, promote the growth of granulation) Taizishen and Dangshen contain saponins and polysaccharides, which can enhance the qi of Astragalus, promote immune cell activity and fibroblast proliferation, accelerate the formation of granulation tissue. Dry and scaly pruritus can add 15g of Rehmannia, 15g of Xuan Shen, 15g of Ophiopogon. (Nourishing yin and moistening dryness, relieving dry and itchy) The three contain iridoid components, which have antioxidant and anti-inflammatory effects, can improve local mucosa / skin dryness (by regulating body fluid metabolism), relieve itching caused by nerve sensitivity during tissue repair process. Pruritus can add 15g of Huang Bai, 15g of Fructus Kochiae, 15g of Bitter Orange Peel. (Clearing heat and drying dampness, dispelling wind and relieving itching) Fructus Kochiae contains triterpenoid saponins, and Bitter Orange Peel contains wilfordine, which can inhibit histamine release (anti-allergic), synergistically enhance the anti-inflammatory and itching effect of Huang Bai, reduce local discomfort.

[0010] As can be seen from the above technical solutions, compared with the prior art, the beneficial effects of the present invention are: (1) The present invention can solve the problems of pain in intractable ulcers, wound infection, and patients with obvious clinical symptoms without effective drug treatment, and can solve the problems of safety and efficacy of external Chinese medicine ointment formulation. (2) The Chinese medicine ointment of the present invention is flexible in diagnosis and treatment, and is composed of basic formula and modified formula. For patients with a single disease, the basic formula has a significant effect. For patients, the modified formula can be adjusted at any time due to changes in their own condition or other treatment methods, or the basic formula can be used in combination. The composition of the prescription is based on the combination of blood-activating and stasis-removing, strengthening the body and eliminating pathogens, dispersing nodules and reducing swelling, and the dosage is summarized from years of clinical experience. (3) Due to its special preparation method, the Chinese medicine ointment of the present invention can add or delete drugs at any time during use, which is more flexible than the traditional Chinese medicine ointment combination. The efficacy is synergistic. F1 replenishes deficiency and promotes repair, F2 removes blood stasis and promotes blood circulation, and F3 detoxifies and controls infection. The three work together to improve the local microenvironment and accelerate healing. (4) The herbal combination of the present invention has relatively mild medicinal properties and safe dosage, making it suitable for external use on most cancer patients with refractory ulcers. All medicinal materials are listed in the pharmacopoeia and, after processing and dosage control, have no obvious irritation. (5) The herbal ointment of the present invention is simple, economical, safe, and effective in preparation. The ointment, which is prepared by mixing decoction with other ingredients, has a suitable texture and can be applied directly to ulcers in different locations. (6) The present invention is effective for ulcers caused by bedsores, diabetic foot, and other complications in elderly cancer patients. (7) In the present invention, the herbal materials can be taken orally, used to clean wounds, made into external ointments, and recycled, increasing the therapeutic effect and avoiding excessive waste of medicine. Attached Figure Description Figure 1 These are before-and-after photos of a patient using the basic formula F1 external application before and after 7 days of treatment. Figure 2 These are before-and-after photos of a patient using the F3 basic formula, and 10 days after treatment.

[0011] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Since its development, the invention has been tested on more than 180 patients, including 32 cases of skin ulcers, 50 cases of dermatitis, 23 cases of herpes zoster, and 32 cases of radiation-induced skin ulcers. These patients showed improvement within 14 days in 150 cases, with 0 cases of allergy, achieving a healing rate of 83%, an improvement rate of 45%, and an effectiveness rate of 100%. Example of basic formula used alone: ​​Example 1 (F1 used alone): Ingredients: F1 (honeysuckle 20 parts, dandelion 15 parts, sophora flavescens 12 parts, violet 15 parts, forsythia 18 parts), mixing agent (beeswax, petrolatum, appropriate amount). Preparation: Prepare F1 herbal ointment according to the method steps, add beeswax and petrolatum, mix to form an ointment. Applicable syndrome type: Heat-toxin accumulation syndrome (redness and swelling of the wound, excessive exudation, accompanied by purulent discharge). Example 2 (F2 alone): Ingredients: F2 (Angelica sinensis 18 parts, Paeonia lactiflora 12 parts, Boswellia carterii 8 parts, Commiphora myrrha 8 parts), blending agent (beeswax, petrolatum as needed). Preparation: Prepare F2 herbal ointment. Applicable syndrome: Blood stasis syndrome (dark purple wound, significant pain, with a small amount of necrotic tissue). Example 3 (F3 alone): Ingredients: F3 (Astragalus membranaceus 25 parts, Angelica dahurica 10 parts, Dracaena cochinchinensis 10 parts, Spatholobus suberectus 20 parts), blending agent (beeswax, petrolatum as needed). Preparation: Prepare F3 herbal ointment. Applicable syndrome: Qi deficiency and blood stasis syndrome (pale red wound, no redness or swelling, slow to heal). Example of mixed application of basic formula: Example 4 (F1+F2+F3, ratio 1:1:1): Ingredients: F1, F2, and F3 are taken according to the optimal weight proportions, mixed to make a herbal ointment, and then the blending agent is added. Applicable syndrome type: Complex syndrome (coexisting redness and paleness of the wound, pain, and excessive exudation). Example of modified formula application: Example 5 (F1+F2+Itching with modifications): Ingredients: F1 (optimal amount) + F2 (optimal amount). For itching, add 10 parts of Phellodendron bark, 8 parts of Kochia scoparia fruit, and 8 parts of Dictamnus dasycarpus root bark. Mix to make a medicinal ointment and then add a harmonizing agent. Applicable syndrome type: Complex syndrome of blood stasis and heat toxicity accompanied by severe itching.

[0012] Typical Case: Case 1: Lung cancer with bone metastasis and lumbosacral skin ulcer, treated with F1 heat-clearing and detoxifying formula combined with F3 tonifying and muscle-regenerating formula as the base prescription. Patient condition: Male, 68 years old, late-stage lung cancer with bone metastasis (lumbosacral region). Due to tumor compression and skin damage after radiotherapy, a 3cm × 2.5cm ulcer formed. The wound was red and swollen with a small amount of exudate, and the edges were hard and tough. The granulation tissue at the base was pale red and growing slowly. The patient also experienced fatigue, shortness of breath, and poor appetite. The wound failed to heal for a long time (duration of disease: 2 months). Diagnosis: Residual heat toxin (redness, swelling, exudate) + Qi deficiency (fatigue, slow granulation tissue growth), which is consistent with the synergistic application of F1 heat-clearing and detoxifying formula and F3 tonifying and muscle-regenerating formula. Treatment Plan (F1+F3 Combined) 1. Basic Formula Combination: F1 Heat-Clearing and Detoxifying Formula (Honeysuckle 15g, Dandelion 20g, Sophora flavescens 15g, Viola yedoensis 15g, Forsythia suspensa 15g): Clears residual heat toxins locally and prevents the spread of infection; F3 Nourishing and Tissue-Regenerating Formula (Astragalus membranaceus 20g, Angelica dahurica 10g, Dragon's Blood 6g, Spatholobus suberectus 15g): Tonifies Qi and invigorates blood, promotes granulation tissue proliferation and wound repair. 2. Adjustments: Due to slow granulation tissue growth, add Codonopsis pilosula 15g and Codonopsis pilosula 15g (to enhance Qi and promote repair); Usage: Oral administration: Decoction of the above herbs, one dose per day, divided into two warm doses in the morning and evening; External application: Decoction of F1 herbs separately, cooled, used to clean the wound and apply as a wet compress, once a day for 20 minutes each time (to reduce stimulation to fragile granulation tissue). Treatment Efficacy (Stage Observation): After 1 week: Wound redness and swelling subsided, exudation stopped, no new signs of infection, and the patient's fatigue was slightly reduced. After 2 weeks: The basal granulation tissue deepened in color (turning bright red) and began to grow towards the center; the ulcer area shrank to 2cm × 1.8cm. After 4 weeks: The ulcer area shrank to 1cm × 0.8cm, the granulation tissue was fully filled, and new epithelial growth was visible at the edges; the patient's appetite improved, and shortness of breath was relieved. Combined Medication Logic: The role of F1: Through the antibacterial and anti-inflammatory effects of honeysuckle, dandelion, etc., potential wound infection is controlled, and the damage of inflammation to granulation tissue is reduced, thus "clearing obstacles" for repair. The role of F3: Astragalus, Codonopsis, etc., which tonify Qi, enhance the body's immunity and repair capabilities; Spatholobus suberectus and Dragon's Blood promote local blood circulation, providing nutrition for granulation tissue growth; Angelica dahurica helps the wound to astringe and regenerate tissue. The two form a progressive relationship of "detoxification-tonification-promoting repair". This case is applicable to the mid-stage of tumor ulceration (infection is basically controlled but the repair momentum is insufficient), reflecting the idea of ​​"clearing first and then replenishing, and combining clearing and replenishing". It is especially suitable for elderly and weak tumor patients, which can enhance their own repair ability by replenishing qi while controlling local inflammation.

[0013] Case 2: Case: Post-mastectomy chest wall tumor ulcer with blood stasis, treated with F2 Blood-Activating and Stasis-Removing Formula as the base. Patient condition: Female, 55 years old, recurrence of chest wall tumor after breast cancer surgery, forming a 4cm×3cm ulcer on the chest wall. The base of the wound is dark purple, with stiff and raised edges (resembling a "levee"), a small amount of dark exudate, and low local skin temperature. The patient reported significant stinging and numbness in the wound, which worsened upon touch (VAS score 5). The course of the disease has been 3 months, and there has been no progress in healing after routine dressing changes. Diagnosis: Blood stasis (dark purple wound, stiff edges, stinging pain), consistent with the applicable pathogenesis of F2 Blood-Activating and Stasis-Removing Formula. Treatment Plan (based on F2): 1. Basic Formula: Prepare a traditional Chinese medicine ointment using the complete F2 formula (Angelica sinensis 10g, Paeonia lactiflora 10g, processed myrrh 6g, processed frankincense 6g). Take an appropriate amount of the herbal liquid and retain it. Soak sterile gauze in the filtered liquid and apply it gently to the wound once daily (avoiding irritation) for 20 minutes each time. The ointment is also used externally. Treatment Effect (observed in stages): After 1 week: The base color of the wound lightens (dark purple → dark red), the frequency of stinging decreases, numbness lessens, and the stiffness at the edges is slightly relieved. After 2 weeks: Capillary proliferation is visible around the wound, scattered fresh granulation tissue appears at the base, the exudate color becomes clearer, and the pain score drops to 3. After 4 weeks: The ulcer area shrinks to 2.5cm × 2cm, the edges soften and begin to shrink towards the center, the granulation tissue at the base is bright red, and the stinging pain basically disappears. This case demonstrates the effectiveness of F2 formula in addressing the core pathogenesis of "blood stasis" in tumor ulcers, and it is particularly suitable for stages of wound ischemia, stiff edges, and stagnant healing, creating conditions for subsequent combination with F3 formula to replenish deficiency and promote tissue regeneration (enhancing repair momentum).

[0014] Case 3: Case: Stage III pressure ulcer in an elderly patient who has been bedridden for a long time, treated with F3 Buxu Shengji Decoction as the base formula. Patient condition: Male, 80 years old, bedridden for a long time due to lung tumor with multiple metastases, developed a stage III pressure ulcer on the sacrum and coccyx, the ulcer area was about 3cm × 4cm, the granulation tissue at the base was pale and edematous, there was no obvious necrotic tissue or exudate, but the growth was slow (no reduction in size after 2 months). The patient also had a pale complexion, fatigue, poor appetite, pale tongue with a thin white coating (suggesting qi deficiency and blood weakness). Diagnosis: Qi deficiency and blood stasis (pale granulation tissue, slow growth, general weakness), which is consistent with the applicable pathogenesis of F3 Buxu Shengji Decoction, which "tonifies qi and invigorates blood, promotes tissue regeneration". Treatment plan 1. Base formula: F3 whole formula (Astragalus membranaceus 20g, Angelica dahurica 10g, Dragon's blood 6g, Spatholobus suberectus 15g), prepared as a Chinese herbal ointment for external use, to replenish the body's vital energy and promote local repair. 2. Adjustments: Due to slow granulation tissue growth, add 15g of Codonopsis pilosula and 15g of Codonopsis pilosula (to enhance qi-tonifying effects and improve the body's repair capabilities); 3. External application: Soak sterile gauze in the F3 formula solution (filtered) and gently cover the wound. Change the dressing once a day (to avoid friction damage to the fragile granulation tissue). Simultaneously, strengthen turning (every 2 hours) and use an air mattress for decompression. Treatment effects (staged observation): After 1 week: The patient's fatigue lessened, appetite slightly improved, and the color of the granulation tissue on the wound slightly deepened (pale → light pink). After 2 weeks: The granulation tissue turned bright red and began to fill towards the center; edema subsided, and the wound area shrank to 2.5cm × 3cm. After 4 weeks: The wound shrank to 1cm × 1.5cm, the base was covered by fresh granulation tissue, and epithelial tissue could be seen crawling at the edges. The patient's mental state significantly improved. This case demonstrates that F3 addresses the core issues of pressure ulcers, namely "qi deficiency and blood weakness, and inability to repair," by using a dual approach of "tonifying deficiency and promoting blood circulation." This approach enhances the body's own repair capabilities while strengthening nursing care, and is particularly suitable for the mid-stage of pressure ulcers (after infection control and slow granulation tissue growth).

[0015] Case 4: Case: Perineal tumor ulcer complicated with infection after rectal cancer surgery, treated with F1 heat-clearing and detoxifying formula as the base formula. Patient condition: Male, 72 years old, pelvic recurrence after rectal cancer surgery, 2cm×3cm ulcer formed in the perineum, the wound was red and swollen, with thick exudate (with odor), the surrounding skin was hot, and the patient reported significant local pain (VAS score 6), body temperature fluctuated between 37.5-38℃, blood routine showed high proportion of white blood cells and neutrophils (considering bacterial infection). Diagnosis: Intense heat and toxin (local redness, swelling, heat and pain, exudate, infection), which is consistent with the applicable pathogenesis of F1 heat-clearing and detoxifying formula. Treatment plan 1. Base formula: F1 whole formula (honeysuckle 15g, dandelion 20g, sophora flavescens 15g, violet 15g, forsythia 15g), 1 dose per day, take the residue to prepare ointment, decoct again to obtain the liquid, cool and apply to the ulcer surface with sterile gauze, twice a day, 30 minutes each time. 2. Targeted Adjustments: Due to excessive exudation and unpleasant odor, 10g of Phellodendron bark (to enhance drying and antibacterial effects) and 15g of Purslane (to astringe exudation) were added and decocted together with Formula F1. Treatment Effects (Stage Observation): After 3 days: Local exudation decreased, odor lessened, body temperature dropped below 37℃, pain was relieved (VAS score 4), and the area of ​​redness and swelling on the wound shrank. After 1 week: Exudation was basically controlled, a small amount of fresh granulation tissue was visible on the wound, the burning sensation of the surrounding skin disappeared, and the proportion of white blood cells and neutrophils returned to normal. After 2 weeks: The ulcer area shrank to 1cm × 1.5cm, the wound was dry, there were no obvious signs of infection, and the pain was basically relieved (VAS score 1-2). This case demonstrates the targeted effect of Formula F1 on the core pathogenesis of "heat-toxin infection" in tumor ulcers, especially suitable for stages with significant inflammation and exudation, laying the foundation for subsequent combination with Formula F2 (promoting blood circulation and removing blood stasis) and Formula F3 (tonifying deficiency and promoting tissue regeneration).

Claims

1. A traditional Chinese medicine ointment (prepared as a decoction) for treating refractory tumor ulcers and its preparation method, characterized in that... The raw material composition by weight is as follows: Basic formulas (3 types): F1 Heat-Clearing and Detoxifying Formula: Honeysuckle 15-25 parts, Dandelion 12-20 parts, Sophora flavescens 10-15 parts, Viola yedoensis 10-18 parts, Forsythia suspensa 15-20 parts. F2 Blood-Activating and Stasis-Removing Formula: Angelica sinensis 15-20 parts, Paeonia lactiflora 10-15 parts, Boswellia carterii 6-10 parts, Commiphora myrrha 6-10 parts; F3 Nourishing and Muscle-Regenerating Formula: Astragalus membranaceus 20-30 parts, Angelica dahurica 8-12 parts, Dragon's Blood 8-12 parts, Spatholobus suberectus 15-25 parts; Addition and subtraction: For excessive exudation, add 8-12 parts of Phellodendron bark, 6-10 parts of Sophora flavescens root, and 10-15 parts of Portulaca oleracea root; For excessive rotten flesh, add 15-20 parts of Smilax glabra (Tufuling); If granulation tissue grows slowly, add 10-15 parts of Astragalus membranaceus, 10-15 parts of Codonopsis pilosula, and 10-15 parts of Codonopsis pilosula. For dry, peeling skin, add 10-15 parts of Rehmannia glutinosa, 10-15 parts of Scrophularia ningpoensis, and 10-15 parts of Ophiopogon japonicus. For itching, add 6-10 parts of Phellodendron bark, 8-12 parts of Kochia scoparia fruit, and 8-12 parts of Dictamnus dasycarpus root bark; Additives: petroleum jelly, beeswax.

2. The herbal ointment (prepared as a traditional Chinese medicine decoction) for treating refractory tumor ulcers according to claim 1, and its preparation method, characterized in that, The optimal weight proportions of each base formula of raw materials are: F1 Heat-Clearing and Detoxifying Formula: Honeysuckle 20 parts, Dandelion 15 parts, Sophora flavescens 12 parts, Viola yedoensis 15 parts, Forsythia suspensa 18 parts. Efficacy: This formula mainly clears heat and detoxifies, and dries dampness. It is suitable for symptoms caused by heat toxins or damp heat, such as sores, boils, carbuncles, and red, swollen, hot, and painful skin. F2 Blood-Activating and Stasis-Removing Formula: Angelica sinensis 18 parts, Paeonia lactiflora 12 parts, Boswellia carterii 8 parts, Commiphora myrrha 8 parts. Efficacy: Primarily functions to activate blood circulation, remove blood stasis, and relieve pain. It can be used for pain and swelling caused by blood stasis, or for lingering blood stasis after external injury. F3 Nourishing and Muscle-Generating Formula: Astragalus membranaceus 25 parts, Angelica dahurica 10 parts, Dragon's Blood 10 parts, Spatholobus suberectus 20 parts. Efficacy: This formula invigorates Qi and nourishes deficiency, promotes blood circulation and muscle regeneration, and is suitable for conditions such as physical weakness, slow-healing sores, and slow muscle growth. Addition and subtraction: For excessive exudation, add 8-12 parts of Phellodendron bark, 6-10 parts of Sophora flavescens root, and 10-15 parts of Portulaca oleracea root (to enhance the effects of clearing heat, drying dampness, and astringing). For cases with excessive necrotic tissue, add 15-20 parts of Smilax glabra (to enhance detoxification and dampness removal, and help remove necrotic tissue). For slow granulation tissue growth, add 10-15 parts of Astragalus membranaceus, 10-15 parts of Codonopsis pilosula, and 10-15 parts of Codonopsis pilosula. (This will enhance the replenishment of Qi and blood, and promote granulation tissue growth). For dryness and peeling, add 10-15 parts of Rehmannia glutinosa, 10-15 parts of Scrophularia ningpoensis, and 10-15 parts of Ophiopogon japonicus. (This nourishes Yin and moistens dryness, relieving dryness and itching). For itching, add 6-10 parts of Phellodendron bark, 8-12 parts of Kochia scoparia fruit, and 8-12 parts of Dictamnus dasycarpus root bark. (Clears heat and dries dampness, dispels wind and relieves itching).

3. The herbal ointment according to claim 1, characterized in that, When the base formula is used in combination, the weight ratio of F1, F2, and F3 is 1-2:1:1-2.

4. A traditional Chinese medicine ointment (prepared as a decoction) for treating refractory tumor ulcers and its preparation method, characterized in that, The specific steps are as follows: (1) Pre-treatment of medicinal materials: Select basic formula and wash them. (2) Extraction of active ingredients: Take the above-mentioned medicinal materials from the basic formula, add 8-10 times the amount of water, soak for 50 minutes, put them in a pot, simmer over low heat for 30 minutes, filter to obtain the liquid; add water to the dregs and simmer for another 20 minutes, filter to obtain the liquid, combine the two liquids, if patients need to take it or rinse the wound, an appropriate amount of liquid can be reserved, the remaining liquid is concentrated over low heat to a thick consistency (about 50-60ml) to facilitate control of the consistency when applying, let it cool for later use (the decoction should be decocted fresh for use, and refrigerated for no more than 24 hours). If the prescription is modified, the drug treatment is the same. (3) Preparation of medicinal pastes: Preparation of traditional Chinese medicine pastes (basic pastes) Extracting medicinal materials for ointment: The remaining Chinese medicine residue after decoction is dried or baked and then chopped and ground into powder; grind into very fine powder and pass through a No. 8 sieve with a mesh size of 150 for later use (to reduce the grainy feel of the ointment and avoid irritating the wound with particles). Melting the base: Put petroleum jelly and beeswax into a clean pot and heat in a water bath (60-70℃), stirring until completely melted, and keep warm for later use. Preparation of the ointment: Slowly add the herbal powder to the molten base while stirring until it is smooth and uniform. After turning off the heat, continue stirring until the temperature of the ointment drops to about 40°C to prevent the powder from becoming ineffective due to high temperature. After the ointment has slightly solidified, dispense it into sterile wide-mouth bottles, seal and refrigerate (shelf life 1 month). (4) Storage: Put the ointment into a sterile wide-mouth bottle, seal it and store it in a cool and dry place (or refrigerate) to avoid contamination. The shelf life is about 1 month. (5) Procedure for preparing and applying decoction Pre-treatment of the ulcer: Rinse the ulcer with saline or the above-mentioned Chinese herbal decoction (before concentration) and gently remove necrotic tissue and secretions (avoid vigorous rubbing). Prepare the ointment: Take 5-10g of Chinese herbal ointment (adjust according to the size of the sore), add 2-5ml of concentrated Chinese herbal decoction, and stir until it becomes a paste (the consistency should be "not dripping and easy to apply"). Application method: Use a sterile cotton swab to evenly apply the prepared paste-like ointment to the wound, about 1-2 mm thick, covering the wound 0.5 cm beyond the edge. Then gently cover and bandage with sterile gauze. Change the dressing 1-2 times a day.

5. A traditional Chinese medicine ointment (prepared as a decoction) for treating refractory tumor ulcers according to claim 3, and its preparation method, characterized in that, In step (2), the soaking time is 50 minutes.

6. The traditional Chinese medicine ointment (prepared as a decoction) for treating refractory tumor ulcers according to claim 3, and its preparation method, characterized in that, In step (2), the traditional Chinese medicine solution can be taken orally or used to rinse the wound.

7. A traditional Chinese medicine ointment (prepared as a decoction) for treating refractory tumor ulcers according to claim 3, and its preparation method, characterized in that, In step (5), the concentrated Chinese herbal decoction is added to prepare the ointment.

8. A traditional Chinese medicine ointment (prepared as a decoction) for treating refractory tumor ulcers according to claim 3, and its preparation method, characterized in that, In step (5), the screen is a No. 8 screen with a mesh size of 150.

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