A traditional Chinese medicine composition for stopping ulceration and promoting tissue regeneration, its preparation method, medicinal ointment, and its application.

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for ulcer repair and tissue regeneration, its preparation method, a traditional Chinese medicine ointment, and its application. The traditional Chinese medicine composition includes the following components: calamine, calcined gypsum, calcined dragon bone, red lead, pearl, camphor, borneol, borax, yellow gelatin, and lanolin. The traditional Chinese medicine composition provided by this invention has the effects of removing necrotic tissue and promoting tissue regeneration, drying dampness and promoting skin growth. It is used to treat vascular-related ulcers such as thromboangiitis obliterans, lower extremity arteriosclerosis obliterans, and lower extremity venous ulcers, and can also treat various chronic and difficult-to-heal ulcers such as bedsores and postoperative wound non-healing, with significant therapeutic effects. This invention also uses specific excipients, namely, utilizing the synergistic effect between refined honey, rosin, and menthol, to prepare an ointment with better permeability and bioavailability.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for stopping ulceration and promoting tissue regeneration, its preparation method, a traditional Chinese medicine ointment, and its application. Background Technology

[0002] Chronic wounds, also known as chronic non-healing wounds or intractable skin ulcers, are a common skin condition characterized by prolonged and slow-healing wounds. These include traumatic injuries, venous ulcers, pressure sores, diabetic foot ulcers, radiation-associated dermatitis, and incontinence-related dermatitis. When the wound site is infiltrated by exudate, the wound remains unhealed, increasing the risk of infection. Furthermore, inflammation can easily spread to deeper tissues, ultimately leading to deep infection and seriously impacting the patient's health and life.

[0003] Chinese invention patent publication number CN113262264A discloses a traditional Chinese medicine composition for pain relief and tissue regeneration, and its preparation method. The traditional Chinese medicine composition includes the following raw materials in parts by weight: 80-110 parts calcined gypsum, 50-70 parts dragon's blood, 35-50 parts cuttlebone, 35-50 parts calcined dragon bone, and 18-30 parts borneol. This invention uses a combination of multiple traditional Chinese medicines to comprehensively treat wounds, and has the effects of promoting tissue regeneration and stopping bleeding, clearing heat and relieving pain, and astringing and healing sores. It has good effects on treating cuts, non-healing wounds after surgery, burns, etc. It prevents the invasion of external bacteria, reduces inflammation, prevents infection, promotes the rapid growth of tissues around the wound, accelerates wound healing, and thus shortens the course of the disease.

[0004] Another Chinese invention patent publication number, CN1197589C, discloses an ointment for treating sores and its preparation method. The ointment is composed of liquid paraffin, calamine, borneol, pearl, borax, ammoniac, artificial bezoar, amber, musk, lanolin, and petrolatum. The steps are as follows: First, the pearl and amber are pulverized; second, the musk, bezoar, and half of the calamine are ground together with the pearl and amber powder; third, the borax, ammoniac, borneol, and calamine are ground together; fourth, the powders are mixed evenly; fifth, the mixed powders are pulverized using a micronization process; sixth, petrolatum is melted, sterilized, and cooled; seventh, lanolin is sterilized; eighth, liquid paraffin is sterilized and cooled; and ninth, petrolatum, lanolin, and liquid paraffin are stirred evenly. This invention has good efficacy for various skin diseases such as impetigo, boils, carbuncles, ulcers, non-healing wounds, and insect bites.

[0005] However, the drugs prepared by the aforementioned invention patents are not very effective in treating refractory ulcers, and their safety is unclear. Therefore, there is an urgent need in the field for a traditional Chinese medicine composition that is more effective in treating refractory ulcers and also has therapeutic effects on vascular-related ulcers such as thromboangiitis obliterans, lower extremity arteriosclerosis obliterans, or lower extremity venous ulcers. Summary of the Invention

[0006] This invention addresses the problems existing in the prior art by providing a traditional Chinese medicine composition for stopping ulceration and promoting tissue regeneration, its preparation method, a traditional Chinese medicine ointment, and its application.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition for stopping ulceration and promoting tissue regeneration includes the following components: calamine, calcined gypsum, calcined dragon bone, red lead, pearl, camphor, borneol, borax, yellow gelatin, and lanolin.

[0008] Preferably, the pearl is nacre powder, and the components also include water.

[0009] Preferably, by weight, it comprises the following components: 15-25 parts calamine, 10-25 parts calcined gypsum, 10-20 parts calcined dragon bone, 5-15 parts red lead, 5-15 parts pearl powder, 10-30 parts camphor, 8-12 parts borneol, 10-20 parts borax, 40-60 parts yellow gelatin, 10-30 parts lanolin, and 150-250 parts water.

[0010] More preferably, by weight, it comprises the following components: 17-23 parts calamine, 12-18 parts calcined gypsum, 12-18 parts calcined dragon bone, 8-12 parts red lead, 8-12 parts pearl powder, 13-27 parts camphor, 9-11 parts borneol, 14-16 parts borax, 48-52 parts yellow gelatin, 16-24 parts lanolin, and 180-220 parts water.

[0011] More preferably, by weight, it comprises the following components: 20 parts calamine, 20 parts calcined gypsum, 15 parts calcined dragon bone, 10 parts red lead, 10 parts pearl powder, 20 parts camphor, 10 parts borneol, 15 parts borax, 50 parts yellow gelatin, 20 parts lanolin, and 200 parts water.

[0012] The medicinal properties and mechanisms of action of each of the above components are as follows: Calamine: [Properties and Channels Entered] Sweet, neutral. Enters the Liver and Spleen channels. [Functions and Indications] Detoxifies, improves vision, removes corneal opacity, astringes dampness, relieves itching, and promotes wound healing. Used for red, swollen, and painful eyes; red and inflamed eyelids; corneal opacity; pterygium covering the eye; non-healing ulcers; oozing pus; and itchy, damp sores.

[0013] Calcined gypsum: [Properties and Channels Entered] Sweet, pungent, astringent, cold. Enters the Lung and Stomach channels. [Functions and Indications] Absorbs dampness, promotes tissue regeneration, heals sores, and stops bleeding. Used externally for non-healing ulcers, eczema and itching, burns, and external bleeding.

[0014] Calcined Dragon Bone: Take the medicinal dragon bone, remove impurities and ash, calcine it according to the method until it turns red-hot, let it cool, remove it, and crush it.

Properties and Channels Entered

Functions and Indications

[0015] Red lead oxide (also known as cinnabar): [Properties and Channels Entered] Pungent, salty, cold. Enters the Heart, Spleen, and Liver channels. [Functions and Indications] Drains toxins and promotes tissue regeneration, eliminates phlegm and calms the nerves. Used for carbuncles, boils, slow-healing ulcers, epilepsy, and mania.

[0016] Pearl powder: [Properties and Channels Entered] Sweet, salty, cold. Enters the Heart and Liver channels. [Functions and Indications] Calms the mind and relieves fright, improves eyesight and removes corneal opacity, detoxifies and promotes tissue regeneration, moisturizes the skin and removes blemishes. Used for palpitations and insomnia, infantile convulsions and epilepsy, red eyes with corneal opacity, non-healing sores, and skin pigmentation.

[0017] Camphor: [Properties and Channels Entered] Pungent, hot. Enters the Heart and Spleen channels. [Functions and Indications] Opens the orifices; promotes qi circulation; dispels foulness; kills parasites and relieves itching; reduces swelling and relieves pain. Used for fever with delirium; sudden collapse due to sudden illness; abdominal pain with vomiting and diarrhea; beriberi due to cold and dampness; scabies and stubborn tinea; tinea capitis; frostbite; leg ulcers; burns; traumatic injuries; toothache; conjunctivitis due to wind and heat.

[0018] Borneol: [Properties and Channels Entered] Pungent, bitter, slightly cold. Enters the Heart, Spleen, and Lung channels. [Functions and Indications] Opens the orifices and awakens the mind, clears heat and relieves pain. Used for delirium due to febrile diseases, convulsions, stroke with phlegm syncope, sudden syncope due to qi stagnation, coma due to sudden illness, chest pain, red eyes, oral ulcers, sore throat, and purulent discharge from the ear canal.

[0019] Borax: [Properties and Channels Entered] Sweet, salty, cool. Enters the Lung and Stomach channels. [Functions and Indications] Clears heat and resolves phlegm; detoxifies and prevents decay. Used for sore throat; mouth and tongue sores; red eyes with pterygium; genital ulcers; bone obstruction; esophageal obstruction; cough with thick phlegm.

[0020] Yellow gelatin: [Properties and Channels Entered] Sweet, neutral. Enters the Lung and Large Intestine channels. [Functions and Indications] Nourishes Yin and moistens dryness; nourishes blood and stops bleeding; invigorates blood and reduces swelling; detoxifies. Mainly used for consumptive lung atrophy; cough with hemoptysis; hematemesis; metrorrhagia; dysentery with hematochezia; traumatic injuries; carbuncles and boils; burns and scalds.

[0021] Lanolin: [Properties and Channels Entered] Sweet, warm. Enters the spleen, heart, and kidney channels. [Functions and Indications] Tonifies deficiency; moistens dryness; dispels wind; detoxifies. Used for general weakness and emaciation; chronic dysentery; dry mouth and constipation; chapped skin; weakness and numbness; erysipelas and carbuncles; sores and tinea; burns and scalds; frostbite.

[0022] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) First, calamine, calcined gypsum and calcined dragon bone are crushed and sieved to obtain powder 1; (2) Mix powder 1, red lead and pearl powder, and sieve to obtain powder 2; (3) Grind the camphor and borneol, sieve them, and obtain powder 3; (4) Finally, heat and mix borax, yellow gelatin, lanolin and water, then add powder 2, keep warm and stir, cool and add powder 3, mix well, and you will get the product.

[0023] Preferably, the mesh size of the sieve in steps (1) to (3) is 80-120 mesh.

[0024] Preferably, in step (4), the heating temperature is 90-110℃; the stirring speed is 200-400 rpm; the stirring time is 5-15 min; and the cooling temperature is 50-60℃.

[0025] The present invention also provides a traditional Chinese medicine ointment for stopping ulceration and promoting tissue regeneration, comprising the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method, and pharmaceutically acceptable excipients.

[0026] Preferably, the excipients include refined honey, rosin, and menthol in a mass ratio of 2-3:1-2:1-2.

[0027] More preferably, the excipients include honey, rosin, and menthol in a mass ratio of 2:1:2.

[0028] Preferably, the mass ratio of the traditional Chinese medicine composition to the excipients is 15-50:1.

[0029] More preferably, the mass ratio of the traditional Chinese medicine composition to the excipients is 30-45:1.

[0030] More preferably, the mass ratio of the traditional Chinese medicine composition to the excipients is 35-40:1.

[0031] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine ointment in the preparation of a medicine for treating ulcers.

[0032] Preferably, the ulcer includes thromboangiitis obliterans, lower extremity arteriosclerosis obliterans, and lower extremity venous ulcers.

[0033] Compared with the prior art, the present invention has the following beneficial effects: (1) The efficacy of the traditional Chinese medicine composition provided by the present invention is: removing necrotic tissue and promoting tissue regeneration, drying dampness and promoting skin growth. It is used to treat thromboangiitis obliterans, arteriosclerosis obliterans of the lower extremities, venous ulcers of the lower extremities and other vascular-related ulcers. It can also treat bedsores, non-healing wounds after surgery and other types of chronic and difficult-to-heal ulcers, with significant therapeutic effects.

[0034] (2) The theory of principal, assistant, adjuvant, and guide herbs in the traditional Chinese medicine composition provided by this invention is as follows: Calamine is the principal herb, which astringes and heals sores; calcined gypsum and calcined dragon bone are the assistant herbs, which help to astringe and heal; borax and camphor are the adjuvant herbs, which detoxify and kill parasites; borneol and camphor are the adjuvant herbs, which relieve pain; pearl powder is the adjuvant herb, which promotes tissue regeneration; and yellow gelatin and lanolin are the guide herbs, which are used to blend and shape the medicine. When all the herbs are used together, they work together to astringe and heal sores, detoxify and reduce swelling, promote tissue regeneration and relieve pain.

[0035] (3) The present invention uses specific excipients, namely, the synergistic effect of honey, rosin and menthol, to prepare ointments with better permeability and bioavailability. Detailed Implementation

[0036] It is worth noting that all raw materials used in this invention are commercially available products. Calcined gypsum, calcined dragon bone, and red lead were purchased from Kanglong Pharmaceutical Co., Ltd.; pearl powder was purchased from Guangdong Meihua Pharmaceutical Co., Ltd.; and borax was purchased from Shaanxi Panlong Yihai Pharmaceutical Co., Ltd.

[0037] Example 1 A traditional Chinese medicine ointment for stopping ulceration and promoting tissue regeneration, by weight, is composed of the following components: 20 parts calamine, 20 parts calcined gypsum, 15 parts calcined dragon bone, 10 parts red lead, 10 parts pearl powder, 20 parts camphor, 10 parts borneol, 15 parts borax, 50 parts yellow gelatin, 20 parts lanolin, 10 parts matrix excipients (composed of refined honey, rosin and menthol in a mass ratio of 2:1:2), and 200 parts water.

[0038] The preparation method of this traditional Chinese medicine ointment is as follows: (1) First, calamine, calcined gypsum and calcined dragon bone are crushed and passed through a 100-mesh sieve to obtain powder 1; (2) Mix powder 1, red lead and pearl powder, and pass through a 100-mesh sieve to obtain powder 2; (3) Grind the camphor and borneol, and pass them through a 100-mesh sieve to obtain powder 3; (4) Finally, heat borax, yellow gelatin, lanolin and water to 100°C and mix them. Then add powder 2, keep warm, stir at 300 rpm for 10 min, cool to 50°C and add powder 3, mix well, add matrix auxiliary materials, stir well, and you will get the product.

[0039] Example 2 A traditional Chinese medicine ointment for stopping ulceration and promoting tissue regeneration, by weight, is composed of the following components: 25 parts calamine, 30 parts calcined gypsum, 10 parts calcined dragon bone, 5 parts red lead, 5 parts pearl powder, 30 parts camphor, 12 parts borneol, 10 parts borax, 40 parts yellow gelatin, 10 parts lanolin, 22 parts matrix excipients (composed of refined honey, rosin and menthol in a mass ratio of 3:1:1), and 250 parts water.

[0040] The preparation method of this traditional Chinese medicine ointment is as follows: (1) First, calamine, calcined gypsum and calcined dragon bone are crushed and passed through a 100-mesh sieve to obtain powder 1; (2) Mix powder 1, red lead and pearl powder, and pass through a 100-mesh sieve to obtain powder 2; (3) Grind the camphor and borneol, and pass them through a 100-mesh sieve to obtain powder 3; (4) Finally, heat borax, yellow gelatin, lanolin and water to 90°C and mix them. Then add powder 2, keep warm, stir at 200 rpm for 5 min, cool to 60°C and add powder 3, mix well, add matrix auxiliary materials, stir well, and you will get the product.

[0041] Example 3 A traditional Chinese medicine ointment for stopping ulceration and promoting tissue regeneration, by weight, is composed of the following components: 15 parts calamine, 10 parts calcined gypsum, 20 parts calcined dragon bone, 15 parts red lead, 15 parts pearl powder, 10 parts camphor, 8 parts borneol, 20 parts borax, 60 parts yellow gelatin, 30 parts lanolin, 8 parts matrix excipients (composed of refined honey, rosin and menthol in a mass ratio of 2:2:1), and 150 parts water.

[0042] The preparation method of this traditional Chinese medicine ointment is as follows: (1) First, calamine, calcined gypsum and calcined dragon bone are crushed and passed through a 100-mesh sieve to obtain powder 1; (2) Mix powder 1, red lead and pearl powder, and pass through a 100-mesh sieve to obtain powder 2; (3) Grind the camphor and borneol, and pass them through a 100-mesh sieve to obtain powder 3; (4) Finally, heat borax, yellow gelatin, lanolin and water to 90°C and mix them. Then add powder 2, keep warm, stir at 200 rpm for 5 min, cool to 60°C and add powder 3, mix well, add matrix auxiliary materials, stir well, and you will get the product.

[0043] Comparative Example 1 Compared with Example 1, the only difference is that calamine is replaced with sophora flavescens, resulting in a traditional Chinese medicine ointment that stops ulceration and promotes tissue regeneration.

[0044] Comparative Example 2 Compared with Example 1, the only difference is that calcined dragon bone is replaced with calcined oyster shell, resulting in a traditional Chinese medicine ointment that stops ulceration and promotes tissue regeneration.

[0045] Comparative Example 3 Compared with Example 1, the only difference is that camphor is replaced with frankincense, resulting in a traditional Chinese medicine ointment that stops ulceration and promotes tissue regeneration.

[0046] Comparative Example 4 Compared with Example 1, the only difference is the component ratio. Specifically, a traditional Chinese medicine ointment for stopping ulceration and promoting tissue regeneration is composed of the following components by weight: 20 parts calamine, 30 parts calcined gypsum, 45 parts calcined dragon bone, 10 parts red lead, 10 parts pearl powder, 20 parts camphor, 5 parts borneol, 5 parts borax, 50 parts yellow gelatin, 20 parts lanolin, 10 parts matrix excipients (composed of refined honey, rosin and menthol in a mass ratio of 2:1:0.2), and 200 parts water.

[0047] Comparative Example 5 Compared with Example 1, the only difference is the preparation method. The preparation method of this traditional Chinese medicine ointment is as follows: (1) First, calamine, calcined gypsum and calcined dragon bone are crushed and passed through a 100-mesh sieve to obtain powder 1; (2) Mix powder 1, red lead and pearl powder, and pass through a 100-mesh sieve to obtain powder 2; (3) Grind the camphor and borneol, and pass them through a 100-mesh sieve to obtain powder 3; (4) Finally, heat borax, yellow gelatin, lanolin and water to 100°C and mix them. Then add powder 2, keep warm, stir at 300 rpm for 10 min, cool to 70°C and add powder 3, mix well, add matrix auxiliary materials, stir well, and you will get the product.

[0048] Comparative Example 6 Compared with Example 1, the only difference is that the matrix excipients are composed of honey and rosin in a mass ratio of 2:1.

[0049] Comparative Example 7 Compared with Example 1, the only difference is that the matrix excipients are composed of refined honey and menthol in a mass ratio of 1:1.

[0050] Comparative Example 8 Compared with Example 1, the only difference is that the matrix excipients consist of rosin and menthol in a mass ratio of 1:2.

[0051] Test Example 1 Epidermal penetration experiments were conducted on the traditional Chinese medicine ointments prepared in Example 1 and Comparative Examples 6-8, respectively. The specific experimental methods are as follows: (1) Test samples: Chinese herbal ointments prepared in Example 1 and Comparative Examples 6-8.

[0052] (2) Experimental animals: SPF grade SD rats, male, weighing 250±20 g.

[0053] (3) Grouping and administration: Rats were randomly divided into 4 groups of 10 each, namely the example group and the comparative examples 6-8.

[0054] Rats were anesthetized with sodium pentobarbital, and then the fur on the back of the animals was shaved to expose a skin area of ​​approximately 3 cm × 3 cm. A 3 mg / cm² solution was then applied. 2 The herbal ointment was evenly applied to the exposed skin area on the animal's back, and then covered with a breathable dressing to prevent the medicine from falling off and becoming contaminated.

[0055] At 1 h, 6 h, 12 h, and 24 h after application, skin tissue was collected from the application site and a surrounding area (within a 1 cm radius of the application center). The collected skin tissue was rinsed thoroughly with physiological saline to remove any residual medication, and then homogenized using a tissue homogenizer. 5 mL of a methanol-water (7:3, v / v) mixture was added, and the mixture was shaken for 30 min. The homogenate was then centrifuged at 10,000 rpm for 10 min, and the supernatant was used as the test sample.

[0056] The content of the main active ingredients in the traditional Chinese medicine ointment in the skin tissue extract was determined by HPLC (calculated as the sum of camphor and borneol content).

[0057] (4) Experimental results: As shown in Table 1, it can be seen from Table 1 that the traditional Chinese medicine ointment of Example 1 has the best drug absorption effect in skin tissue. Example 1 performs better than Comparative Examples 6-8 in terms of drug absorption indicators, indicating that the traditional Chinese medicine ointment of the present invention has better release and absorption characteristics.

[0058] Table 1 Results of drug absorption test

[0059] Note: Compared with Example 1, # This indicates that p < 0.05. ## This indicates that p < 0.01.

[0060] Test Example 2 The effects of the traditional Chinese medicine ointments prepared in Examples 1-3 and Comparative Examples 1-5 on the rat model of deep vein ulceration in the lower extremities were studied. The specific experiments are as follows: (1) Test samples: Chinese herbal ointments prepared in Examples 1-3 and Comparative Examples 1-5.

[0061] (2) Experimental animals: SPF grade SD rats, male, weighing 250±20 g.

[0062] (3) Establishment of a deep vein ulcer model of the lower extremities: After anesthetizing the rats, the hair at the root of the left thigh was cut off, and the rats were placed in a supine position with their limbs abducted and fixed. The rats were disinfected with medical iodine, covered with a sterile perforated drape, and the medial field of vision of the left groin was exposed. An incision of 2.0-2.5 cm in length was made in the center of the field of vision with ophthalmic scissors. After blunt dissection of the subcutaneous tissue, the common iliac vein was exposed and separated. The proximal, tributary and distal ends of the left common iliac vein of the rat were ligated with 3-0 surgical silk sutures. After ligation, the blood vessels at the ligation site were congested and thickened. After repositioning the surrounding tissues, the muscle layer and skin were sutured continuously with silk sutures. The incision was disinfected with iodine. The rats were housed in individual cages, and the abdominal incision was disinfected with iodine once a day.

[0063] Three days later, the rats were anesthetized, and the modeling location was marked with a 1.5 cm diameter punch. Full-thickness skin was cut from the marked location to create a 1.5 cm diameter circular skin defect reaching the deep subcutaneous fascia, thus establishing a deep vein ulcer model of the lower extremities.

[0064] (4) Grouping and administration: Rats were randomly divided into 12 groups of 10 each, namely the model group, positive drug group, low-dose group of Example 1, medium-dose group of Example 1, high-dose group of Example 1, group 2, group 3 and comparative examples 1-5.

[0065] In the positive control group, mupirocin ointment was applied evenly to the rat wounds at a daily dose of 0.2 g. In Example 1, the low-dose group received 0.1 g of the herbal ointment prepared in Example 1 daily; the medium-dose group received 0.2 g of the herbal ointment prepared in Example 1 daily; the high-dose group received 0.5 g of the herbal ointment prepared in Example 1 daily; and the groups in Examples 2-3 and Comparative Examples 1-5 received 0.2 g of the corresponding herbal ointment daily. The model group received no treatment. The medication was applied twice daily for 14 consecutive days. Wound healing was observed and recorded on days 1, 7, and 15, and the wound healing rate was calculated using the following formula: Wound healing rate (%) = (Initial wound area - Unhealed area on the current day) ÷ Initial wound area × 100% (5) The wound healing rate of each group of rats is shown in Table 2. As can be seen from Table 2, compared with the model group, the wound healing rate of the positive drug group and the example group was significantly improved, and the differences were statistically significant (p<0.05 or p<0.01). This indicates that the Chinese medicine ointment provided by the present invention can effectively promote the healing of ulcer wounds and the effect is better than that of commercially available ointments.

[0066] Table 2 Wound healing rate results

[0067] Note: Compared with the model group, # This indicates that p < 0.05. ## This indicates that p < 0.01.

[0068] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for stopping ulceration and promoting tissue regeneration, characterized in that, It includes the following components: calamine, calcined gypsum, calcined dragon bone, red lead, pearl, camphor, borneol, borax, yellow gelatin, and lanolin.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The pearl is nacre powder, and the components also include water.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, By weight, it comprises the following components: 15-25 parts calamine, 10-25 parts calcined gypsum, 10-20 parts calcined dragon bone, 5-15 parts red lead, 5-15 parts pearl powder, 10-30 parts camphor, 8-12 parts borneol, 10-20 parts borax, 40-60 parts yellow gelatin, 10-30 parts lanolin, and 150-250 parts water.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, By weight, it comprises the following components: 17-23 parts calamine, 12-18 parts calcined gypsum, 12-18 parts calcined dragon bone, 8-12 parts red lead, 8-12 parts pearl powder, 13-27 parts camphor, 9-11 parts borneol, 14-16 parts borax, 48-52 parts yellow gelatin, 16-24 parts lanolin, and 180-220 parts water.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 2-4, characterized in that, Includes the following steps: (1) First, calamine, calcined gypsum and calcined dragon bone are crushed and sieved to obtain powder 1; (2) Mix powder 1, red lead and pearl powder, and sieve to obtain powder 2; (3) Grind the camphor and borneol, sieve them, and obtain powder 3; (4) Finally, heat and mix borax, yellow gelatin, lanolin and water, then add powder 2, keep warm and stir, cool and add powder 3, mix well, and you will get the product.

6. The preparation method according to claim 5, characterized in that, The mesh size for sieving in steps (1) to (3) is 80-120 mesh. In step (4), the heating temperature is 90-110℃; the stirring speed is 200-400 rpm and the stirring time is 5-15 min; the cooling temperature is 50-60℃.

7. A traditional Chinese medicine ointment for stopping ulceration and promoting tissue regeneration, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method according to claim 5 or 6, and pharmaceutically acceptable excipients.

8. The traditional Chinese medicine ointment according to claim 7, characterized in that, The excipients include refined honey, rosin, and menthol in a mass ratio of 2-3:1-2:1-2.

9. The traditional Chinese medicine ointment according to claim 7, characterized in that, The mass ratio of the traditional Chinese medicine composition to the excipients is 15-50:

1.

10. The use of a traditional Chinese medicine composition according to any one of claims 1-4 or a traditional Chinese medicine ointment according to any one of claims 7-9 in the preparation of a medicament for treating ulcers, characterized in that, The ulcers include thromboangiitis obliterans, arteriosclerosis obliterans of the lower extremities, and venous ulcers of the lower extremities.

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