Traditional Chinese medicine composition for repairing and treating tumor damage and preparation thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for repairing and treating tumor damage, the traditional Chinese medicine composition can be orally taken or externally applied, and through oral administration or external application or a synergistic effect, the tumor ulceration symptom is rapidly controlled, wound healing is promoted, and the medical cost is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for treating tumor wound repair and its preparations. Background Art

[0002] The rupture of superficial tumors is a common complication of malignant tumor patients, mainly caused by rapid tumor proliferation leading to local ischemia and necrosis, external force injury or secondary infection. The clinical manifestations are wound pain, bleeding, exudation, foul odor, infection spread and tumor cell exposure. In severe cases, it can cause septicemia or tumor metastasis, endangering life.

[0003] Currently, clinical treatment mainly relies on methods such as debridement, suture, anti-infection and surgical resection, but there are the following defects:

[0004] (1) Traditional suture is difficult to effectively heal complex wounds, such as large area, irregular or near important organs, and is prone to scar formation or secondary damage, with limited healing effect;

[0005] (2) Tumor patients have low immunity, and debridement or implanted materials are prone to cause infection, interfering with healing or even leading to systemic infection, with a high risk of infection;

[0006] (3) Some repair techniques may damage the functions of surrounding normal tissues, such as swallowing, speech, joint movement,

[0007] (4) The repair material may cover up the signs of tumor recurrence, delaying treatment and making it difficult to monitor recurrence.

[0008] (5) Advanced therapies such as artificial skin and stem cell therapy are complex in operation and high in cost, and it is difficult to popularize the technology which is complex and costly.

[0009] (6) There is a lack of personalized solutions for different tumor types, locations and patient conditions.

[0010] Moreover, existing drugs have single functions, slow effects and are prone to recurrence, and cannot meet the needs of synchronous treatment of multiple symptoms of tumor rupture. Summary of the Invention

[0011] The purpose of the present invention is to provide a traditional Chinese medicine composition with multiple effects in one and simple operation. By taking orally, applying externally or through synergistic action, it can quickly control the symptoms of tumor rupture, promote wound healing and reduce medical costs. This purpose is achieved through the following technical solutions:

[0012] The first aspect of the present invention provides a traditional Chinese medicine composition for treating tumor wound repair, wherein the composition is composed of the following raw materials in parts by weight: 10 - 25 parts of honeysuckle, 6 - 15 parts of dandelion, and 15 - 40 parts of noni fruit.

[0013] Further, the composition is composed of the following raw medicinal materials by weight: 15-20 parts of honeysuckle, 9-12 parts of dandelion, and 18-30 parts of noni fruit.

[0014] Further, the composition is composed of the following raw medicinal materials by weight: 20 parts of honeysuckle, 12 parts of dandelion, and 30 parts of noni fruit.

[0015] The preparation method of the composition includes the following steps:

[0016] a. Weigh the raw materials according to each weight ratio;

[0017] b. Select a traditional Chinese medicine decocting pot and preheat it over low heat for 8-12 minutes;

[0018] c. Cut the honeysuckle, dandelion, and noni fruit into pieces, put them into the preheated traditional Chinese medicine decocting pot, then add pure water with a weight of 4-6 times that of the raw materials for the first time, and then stir and soak for 60-90 minutes;

[0019] d. For the traditional Chinese medicine decocting pot containing the soaked honeysuckle, dandelion, and noni fruit, first bring the water to a boil over high heat, then turn to low heat and simmer for 30-60 minutes, filter out the juice and residue with a filter screen, and temporarily let it cool;

[0020] e. Conduct a second decoction on the cooled traditional Chinese medicine decocting pot in step c. For the second decoction, add pure water with a weight of 3-5 times that of the remaining residue after filtration in step d. First bring the water to a boil over high heat, then turn to low heat and simmer for 20-30 minutes, and then filter out the juice and residue with a filter screen and temporarily let it cool;

[0021] f. Conduct a third decoction on the cooled traditional Chinese medicine decocting pot in step d. For the third decoction, add pure water with a weight of 2-3 times that of the remaining residue after filtration in step e. First bring the water to a boil over high heat, then turn to low heat and simmer for 20-30 minutes, and then filter out the juice and residue with a filter screen and temporarily let it cool;

[0022] g. Mix the juice filtered out by the filter screens in steps d, e, and f, pour it into the traditional Chinese medicine decocting pot, continuously stir and heat over low heat for 8-12 minutes for concentration to the required dosage, filter the juice with a filter screen, and after cooling, divide it into water-based preparations.

[0023] Further, in the preparation method of the composition, in step a, select clean, impurity-free, and non-moldy honeysuckle and dandelion, and select noni fruits that are eight-tenths ripe. Cut the noni fruits into slices, let them dry naturally in the shade, and then wash them clean and set aside.

[0024] Further, the usage methods of the preparation include oral administration, wet compress, application, perfusion, or gargling.

[0025] Furthermore, the use of the traditional Chinese medicine composition in the preparation of a drug for repairing damaged surface tumors, wherein the drug is used to inhibit tumor growth.

[0026] Furthermore, for the above use, the damaged tumor is a damaged wound of lung cancer, lymphoma, breast tumor, oropharyngeal cancer, melanoma, vulvar cancer, cervical cancer, low rectal cancer, hemangioma, epithelial cell carcinoma or osteosarcoma.

[0027] The advantages and beneficial effects of the present invention are as follows:

[0028] (1) A traditional Chinese medicine composition for treating damaged tumors of the present invention achieves pain relief, hemostasis, reduced exudation, and elimination of odor through multi-effect synergistic effects, significantly improving the repair effect of complex wounds; the present invention has a fast healing rate, with an average healing time of 16 to 35 days, which is significantly better than traditional therapies.

[0029] (2) A traditional Chinese medicine composition for treating damaged tumors of the present invention reduces the risk of infection through dual mechanisms of antibacterial and immunomodulatory effects.

[0030] (3) A traditional Chinese medicine composition for treating damaged tumors of the present invention adopts non-invasive oral, wet compress, smear, perfusion or gargle therapies, avoiding physical damage to normal tissues.

[0031] (4) A traditional Chinese medicine composition for treating damaged tumors of the present invention reduces the risk of recurrence by inhibiting the activity and metabolism of tumor cells.

[0032] (5) The raw materials of a traditional Chinese medicine composition for treating damaged tumors of the present invention are common medicinal materials, honeysuckle, dandelion and noni fruit, with low cost, simple extraction process, flexible operation and easy popularization.

[0033] (6) A traditional Chinese medicine composition for treating damaged tumors of the present invention achieves personalized treatment through flexible compatibility and multi-channel drug administration, adjusts the dosage according to the size of the wound, and the dosage form is suitable for special parts such as irregular, cavity, joint, etc.

[0034] (7) A traditional Chinese medicine composition for treating damaged tumors of the present invention has high safety, natural ingredients, no risk of immune rejection, simple operation, does not require professional medical staff, and dressing change can be completed at home. Description of the Drawings

[0035] By reading the following detailed description of the preferred embodiments, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Throughout the drawings, the same reference numerals are used to represent the same components.

[0036] In the drawings:

[0037] Figure 1 Efficacy comparison of the traditional Chinese medicine combined liquid of Example 1 of the present invention on the wound surface of a pharyngeal cancer patient in Typical Case 1

[0038] Figure 2 Efficacy comparison of the traditional Chinese medicine combined liquid of Example 1 of the present invention on the wound surface of a lymphoma rupture patient in Typical Case 2

[0039] Figure 3 Efficacy comparison of the traditional Chinese medicine combined liquid of Example 1 of the present invention on the wound surface of an aortic hemangioma patient in Typical Case 3

[0040] Figure 4 Efficacy comparison of the traditional Chinese medicine combined liquid of Example 1 of the present invention on the wound surface of a breast tumor patient in Typical Case 4

[0041] Figure 5 Efficacy comparison of the traditional Chinese medicine combined liquid of Example 1 of the present invention on the wound surface of an axillary lymph node tumor rupture patient in Typical Case 6

[0042] Figure 6 Efficacy comparison of the traditional Chinese medicine combined liquid of Example 1 of the present invention on the wound surface of a patient with advanced hemangioma in Typical Case 8 Detailed implementation manners

[0043] The present invention will be further described below in conjunction with specific embodiments.

[0044] Honeysuckle: Also known as Lonicera japonica, it is the dried flower buds or newly opened flowers of an evergreen vine of the genus Lonicera in the Caprifoliaceae family. It is sweet and cold in nature, and belongs to the lung, heart, and stomach meridians. It has the effects of clearing heat and detoxifying, and dispersing wind and heat. It is a traditional Chinese medicine and food homologous plant in China. Its main components are flavonoids, volatile oils, organic acids, and have anti-inflammatory, antioxidant, anti-tumor, and antiviral effects. Components such as chlorogenic acid can destroy the bacterial cell wall, stimulate the activity of lysozyme, inhibit the activity of bacterial enzymes, inhibit the growth and reproduction of bacteria, can promote the transformation of lymphocytes, enhance the phagocytic ability of white blood cells, thereby improving the body's immunity and enhancing the body's anti-infection ability. Luteolin in honeysuckle can block the NF-kB signaling pathway, reduce the expression of pro-inflammatory factors such as TNF-a, IL-1β, IL-6, etc., thereby inhibiting the inflammatory response. The effects of honeysuckle: antibacterial and antiviral, inhibiting Staphylococcus aureus, influenza virus, etc.; anti-inflammatory, reducing pro-inflammatory factors (TNF-α, IL-6) by blocking the NF-kB pathway; immune regulation, enhancing lymphocyte transformation and white blood cell phagocytic function.

[0045] Dandelion: A perennial herbaceous plant of the genus Taraxacum in the Compositae family, also known as Huanghuadiding and Popoding. It is bitter, sweet, and cold in nature, and belongs to the liver and stomach meridians. It has the effects of clearing heat and detoxifying, dissipating swelling and nodules, and promoting diuresis and relieving stranguria. It is a plant with both medicinal and edible uses. Anti-inflammatory and antibacterial: It inhibits Staphylococcus aureus and Streptococcus hemolyticus, and relieves mastitis and intestinal abscess. Dandelion efficacy: Antioxidant, scavenging free radicals, protecting liver cells; Cholagogic and hepatoprotective: Promoting bile secretion, improving damp-heat jaundice, and anti-inflammatory.

[0046] Noni fruit: The fruit of a tropical evergreen shrub of the genus Morinda in the Rubiaceae family, also known as Morinda citrifolia and Noni fruit. It is neutral in nature, pungent and sweet in taste, and belongs to the kidney, liver, and spleen meridians. It has the effects of antioxidant, anti-inflammatory, and immune regulation, etc. It is a traditional medicinal plant in the South Pacific. Noni fruit efficacy: Anti-inflammatory and analgesic: Relieving arthritis pain by inhibiting the COX-2 pathway; Immune regulation: Activating lymphocytes and macrophages, enhancing antiviral ability; Antioxidant: Scavenging free radicals, delaying cell aging.

[0047] A traditional Chinese medicine composition for treating tumor damage repair of the present invention, the composition is composed of the following raw materials in parts by weight: 10-25 parts of honeysuckle, 6-15 parts of dandelion, and 15-40 parts of noni fruit. It is combined with pure water to prepare an aqueous solution. Honeysuckle: Clearing heat and detoxifying, antibacterial and anti-inflammatory, enhancing immunity, and anti-tumor. As one of the main components of the traditional Chinese medicine composition, through its effects of clearing heat and detoxifying, antibacterial and anti-inflammatory, and anti-tumor, it provides a good environment for the healing of the wound surface, and helps to reduce the occurrence of inflammation and infection. Dandelion: Clearing heat and detoxifying, dissipating swelling and nodules, diuretic and laxative. The effect of dandelion in dissipating swelling and nodules helps to relieve the swelling and pain caused by tumor damage. At the same time, its effects of clearing heat and detoxifying and diuretic and laxative also help to accelerate the healing of the wound surface and the recovery of the body. Noni fruit: Antioxidant, regulating the immune system, anti-inflammatory, relieving pain, and anti-tumor. As another main component of the cell repair fluid, through its effects of antioxidant, regulating the immune system, anti-inflammatory, relieving pain, and anti-tumor, it provides comprehensive support for the healing of the wound surface. Its antioxidant and anti-inflammatory effects help to reduce the oxidative stress and inflammatory response of the wound surface, while the effects of regulating the immune system and relieving pain help to accelerate the healing of the wound surface and improve the quality of life of patients.

[0048] The compatibility of honeysuckle, dandelion, and noni fruit can produce a synergistic effect and jointly play the role of treating tumor damage repair. This compatibility not only enhances their respective pharmacological effects, but also expands the treatment scope and improves the treatment effect. Based on their respective unique pharmacological effects and the synergistic effect between them, it accelerates the healing of the tumor damage wound surface in a multi-effect combination manner and improves the quality of life of patients.

[0049] I. Preparation of traditional Chinese medicine composition

[0050] The following Examples 1-3 are calculated according to 1 part = 100 grams.

[0051] Example 1

[0052] 1. Chinese medicine raw materials and weights

[0053] 2000 grams of honeysuckle, 1200 grams of dandelion, 3000 grams of noni fruit.

[0054] 2. Preparation method

[0055] a. Weigh the raw materials according to the respective weight ratios;

[0056] b. Select a Chinese medicine decocting pot, and preheat it over low heat for 10 minutes; make the whole pot evenly heated and its performance stable, so as to better retain the medicinal properties.

[0057] c. Cut the honeysuckle, dandelion and noni fruit into pieces, put them into the preheated Chinese medicine decocting pot, then add pure water with a weight of 5 times the weight of the raw materials for the first time, and then stir and soak for 60 minutes; make the medicinal materials fully absorb water, which is beneficial to the dissolution of ingredients.

[0058] d. For the Chinese medicine decocting pot containing the soaked honeysuckle, dandelion and noni fruit, first bring the water to a boil over high heat, then turn to low heat and simmer for 30 minutes, filter out the juice and residue with a filter screen, and temporarily let it cool;

[0059] e. Conduct a second decoction on the cooled Chinese medicine decocting pot in step c. For the second decoction, add pure water with a weight of 4 times the weight of the remaining residue after filtration in step d. First bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes, and then filter out the juice and residue with a filter screen, and temporarily let it cool;

[0060] f. Conduct a third decoction on the cooled Chinese medicine decocting pot in step d. For the third decoction, add pure water with a weight of 3 times the weight of the remaining residue after filtration in step e. First bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes, and then filter out the juice and residue with a filter screen, and temporarily let it cool;

[0061] g. Mix the juice filtered out in steps d, e, and f, pour it into the Chinese medicine decocting pot, continuously stir and heat over low heat for 10 minutes for concentration to the required dosage, filter the juice with a filter screen, and after cooling, divide it into water-based preparations.

[0062] Furthermore, in step a, select clean, impurity-free and non-moldy honeysuckle and dandelion, and for the noni fruit, select fruits that are eight-tenths ripe. Cut the noni fruit into slices, let it dry naturally in the shade, and then wash it clean and set aside.

[0063] Example 2

[0064] 1. Chinese medicine raw materials and weights

[0065] 1000 grams of honeysuckle, 600 grams of dandelion, 1500 grams of noni fruit.

[0066] 2. Preparation method

[0067] a. Weigh the raw materials in each weight ratio.

[0068] b. Select a traditional Chinese medicine decocting pot, and preheat it over low heat for 10 minutes to make the whole pot evenly heated and have stable performance, so as to better retain the medicinal properties.

[0069] c. Cut honeysuckle, dandelion and noni fruit into pieces, put them into the preheated traditional Chinese medicine decocting pot, then add pure water with a weight of 5 times that of the raw materials for the first time, and then stir and soak for 60 minutes to make the medicinal materials fully absorb water, which is beneficial to the dissolution of components.

[0070] d. For the traditional Chinese medicine decocting pot containing the soaked honeysuckle, dandelion and noni fruit, first bring the water to a boil over high heat, then turn to low heat and simmer for 30 minutes, filter out the liquid and residue with a strainer, and temporarily let it cool.

[0071] e. Conduct a second decoction on the cooled traditional Chinese medicine decocting pot in c. For the second decoction, add pure water with a weight of 4 times that of the remaining residue after filtration in d. First bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes, and then filter out the liquid and residue with a strainer and temporarily let it cool.

[0072] f. Conduct a third decoction on the cooled traditional Chinese medicine decocting pot in d. For the third decoction, add pure water with a weight of 3 times that of the remaining residue after filtration in e. First bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes, and then filter out the liquid and residue with a strainer and temporarily let it cool.

[0073] g. Mix the liquid filtered out by the strainers in d, e and f, pour it into the traditional Chinese medicine decocting pot, continuously stir and heat over low heat for 10 minutes for concentration to the required amount, filter the liquid with a strainer, and after cooling, divide and package it into a liquid preparation.

[0074] Furthermore, in step a, select clean, impurity - free and non - mildewed honeysuckle and dandelion, and for the noni fruit, select fruits that are eight - tenths ripe. Slice the noni fruit, let it dry naturally in the shade, and then wash it clean for standby.

[0075] Example 3

[0076] 1. Traditional Chinese medicine raw materials and weights

[0077] 2500 grams of honeysuckle, 1500 grams of dandelion, 4000 grams of noni fruit.

[0078] 2. Preparation method

[0079] a. Weigh the raw materials in each weight ratio.

[0080] b. Select a traditional Chinese medicine decocting pot, and preheat it over low heat for 10 minutes to make the whole pot evenly heated and have stable performance, so as to better retain the medicinal properties.

[0081] c. Cut honeysuckle, dandelion, and noni fruits into segments, put them into a preheated traditional Chinese medicine decocting pot, then add pure water with a weight of 5 times that of the raw materials for the first time, and then stir and soak for 60 minutes; this allows the medicinal materials to fully absorb water, facilitating the dissolution of components.

[0082] d. For the traditional Chinese medicine decocting pot containing the soaked honeysuckle, dandelion, and noni fruits, first bring the water to a boil over high heat, then turn to low heat and simmer for 30 minutes. Filter out the liquid and residue with a strainer, and temporarily set it aside to cool.

[0083] e. Conduct a second decoction on the cooled traditional Chinese medicine decocting pot in step c. For the second decoction, add pure water with a weight of 4 times that of the remaining residue after filtration in step d. First bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes, and then filter out the liquid and residue with a strainer, and temporarily set it aside to cool.

[0084] f. Conduct a third decoction on the cooled traditional Chinese medicine decocting pot in step d. For the third decoction, add pure water with a weight of 3 times that of the remaining residue after filtration in step e. First bring the water to a boil over high heat, then turn to low heat and simmer for 20 minutes, and then filter out the liquid and residue with a strainer, and temporarily set it aside to cool.

[0085] g. Mix the liquid filtered out in steps d, e, and f, pour it into the traditional Chinese medicine decocting pot, continuously stir and heat over low heat for 10 minutes for concentration to the required dosage, filter the liquid with a strainer, and after cooling, divide it into water-based preparations for packaging.

[0086] Furthermore, in step a, select clean, impurity-free, and non-moldy honeysuckle and dandelion. For noni fruits, select fruits that are eight-tenths ripe. Cut the noni fruits into slices, dry them naturally in the shade, and then wash them clean and set aside.

[0087] II. The beneficial effects of the present invention are illustrated by the following Experimental Example 1

[0088] 1. Experimental materials

[0089] Yunnan Baiyao Plaster: One piece each time, 6.5 cm * 10 cm, once a day

[0090] Kangfuxin Solution: 20 ml each time, three times a day for wound cleaning

[0091] Silver Ion Anti-inflammatory Ointment: 3 g each time, twice a day for the first three days before use, and then once a day after three days

[0092] Hydrogen Peroxide: 3% hydrogen peroxide solution, twice a day for rinsing

[0093] Ceftriaxone: 2 g each time, administered twice a day

[0094] Ofloxacin Injection: 0.2 g each time, intravenously infused twice a day

[0095] The traditional Chinese medicine composition of the present invention: 30 ml each time, once a day

[0096] 2. Types of damaged tumor wounds

[0097] Damaged wounds of breast tumors and damaged wounds of low rectal cancer.

[0098] 3. Methods and results

[0099] (1) Repair of damaged breast tumors

[0100] In the enrolled cases, there were 17 cases of late in-situ recurrence and damage, 9 cases of tumor recurrence and breast metastasis and damage, 12 cases of radiotherapy damage, 7 cases of postoperative wound infection and damage, 6 cases of initial diagnosis damage, and 9 cases of chemotherapy drug side effect damage, with a total of 60 cases.

[0101] The age range of the patients was from 30 to 65 years old, all were female, with no restrictions on occupation and weight, the wound area was within 7 cm * 10 cm, the wound depth was from the sternum to the epidermis, and all patients were cases of damaged infection. The patients were divided into 3 groups, with 20 people in each group.

[0102] In experimental group 1, Kangfuxin Liquid was used. Each time 20 ml was used, and the wound was cleaned three times a day. Then, silver ion anti-inflammatory ointment was used: 3 g each time, twice a day for the first three days, and then once a day after three days, followed by dressing. In experimental group 2, Yunnan Baiyao was used, one tablet each time, once a day, and 3% hydrogen peroxide solution was used to rinse the wound twice a day, followed by dressing the wound. In experimental group 3, the traditional Chinese medicine composition of the present invention was used. Each time 30 ml was used, once a day. After rinsing the wound with saline, a degreased cotton sheet was covered, and the area of the cotton sheet was 1 cm larger than the wound edge. The cotton sheet was drenched with the liquid medicine, and it was exposed and waited for the liquid medicine to be completely absorbed by the wound before dressing, and the dressing was changed every day. After one week of observation, it could be clearly seen that the bleeding phenomenon, pain and tightness, and infection smell at the wound using the present invention were significantly better than those in experimental group 1 and experimental group 2. The results are shown in Table 1.

[0103] (2) Repair of damaged low rectal cancer within 5 cm from the anus

[0104] In the enrolled cases, there were 30 patients with postoperative non-healing infected wound damage, 35 patients with radiotherapy damage at the rectal tumor site, and 15 patients with chemotherapy and targeted drug rectal damage, with a total of 80 patients.

[0105] The age range of the patients was from 30 to 70 years old, with no gender restrictions. The inclusion criteria were that white or yellow secretions appeared at the rectal damage site, there was continuous dripping, accompanied by irregular bleeding, obvious pain, the desire to defecate many times a day but actually unable to defecate, there was always a feeling of residual feces at the anus, and there was involuntary fecal leakage at any time and unable to stay away from the toilet, seriously affecting the quality of life. The damage time was from 6 months to 3 years. The patients were divided into 4 groups, with 20 people in each group.

[0106] Experimental group 4 used topical hydrogen peroxide, 3% hydrogen peroxide solution, rinsed twice a day and combined with ceftriaxone: 2g each time, twice a day; experimental group 5 used Kangfuxin liquid: 20ml each time, three times a day for wound cleaning. Experimental group 6 used ofloxacin injection, 0.2g each time. Intravenous drip twice a day. Experimental group 7 used the Chinese medicine composition of the present invention, 10ml each time, pushed into the intestine with a rectal perfusion device, the depth of the rectal tube entering the intestine was greater than 1cm from the highest point of the wound, and each posture was maintained for 10-15 minutes in supine, left side, right side, and prone position, and then perfused the next time, and perfused continuously for 3 times, with a total dosage of 30ml. In the first three days, more white or yellow exudate and viscous substances will be discharged from the body. After three days, the patient's pain is significantly relieved, and only a slight feeling of stuffiness and distension, the feeling of anal stool disappears, and the stool is formed in about a week. There is only one defecation after applying the medicine in a day, and there is no feeling of defecation many times in the rest of the time. There is basically no bleeding phenomenon, and there is occasionally friction blood on the stool, and the quality of life is significantly improved. The healing time is less than 20 days. The results are shown in Table 2.

[0107] Table 1 Comparison of the effects of the present invention on the repair of breast tumor damage (used for 10 days)

[0108]

[0109] According to the above experimental comparison, the bacterial film of the Chinese medicine composition of the present invention was reduced by 70%, the amount of bleeding was reduced by 58%, the odor was reduced by 85%, and the repair rate was 90%. The present invention has a clear effect and long-term clinical significance on the repair of breast tumor damage. Symptom changes show that tumor damage repair plays an important role in tumor growth, metastasis and immune escape, and also shows that controlling the tumor damage repair process plays an important role in tumor treatment. The present invention inhibits bacterial growth, reduces wound infection, enhances the body's anti-infection ability, inhibits tumor inflammatory growth, promotes tissue fluid metabolism, accelerates the generation of new granulation tissue, and shortens the healing time.

[0110] Table 2 Comparison of the repairing effect of the present invention on the damage of lower rectal cancer (one week of use)

[0111]

[0112] According to the above experimental comparison, the exudate of the Chinese medicine composition of the present invention was reduced by 90%, the pain was reduced by 87%, the stool sensation disappeared, and the repair rate was 95%. The present invention has a clear effect and long-term clinical significance for the repair of low-segment rectal cancer damage. Symptom changes show that tumor damage repair plays an important role in tumor growth, metastasis and immune escape, and also show that controlling the tumor damage repair process plays an important and key role in tumor treatment. The present invention inhibits bacterial growth, reduces wound infection, enhances the body's anti-infection ability, inhibits tumor inflammatory growth, promotes tissue fluid metabolism, accelerates the generation of new granulation tissue, and shortens healing time.

[0113] III. Clinical Efficacy of the Trial Example 1

[0114] Trial Experimental Example 1: Clinical efficacy of the composition of the present invention in inhibiting tumor breakage and accelerating breakage repair.

[0115] Clinical cases: A total of 68 cases were observed, with the age range from 30 to 75 years old, and the average age was 56.79 ± 12.68 years old.

[0116] Inclusion criteria: Patients with tumor breakage, including inflammatory tumor breakage caused by chemotherapy and targeted drugs, radiation-induced tumor thermal injury breakage, tumor natural growth breakage, accidental injury-induced tumor site breakage, advanced tumor spread breakage, with the breakage area in the range of 3 cm - 20 cm, accompanied by bleeding, abnormal smell, tissue fluid overflow, and obvious pain.

[0117] Exclusion criteria: a. Those who do not meet the inclusion criteria; b. Those without epidermal breakage; c. Those intolerant to traditional Chinese medicine in this protocol and those who are participating in other repair treatments; d. Those who meet the inclusion criteria but have poor compliance with medical orders or cannot be followed up regularly, so that the curative effect cannot be determined or the data is incomplete and the curative effect cannot be evaluated.

[0118] Treatment method: Disinfect the epidermal surface and surrounding skin tissues of the wound surface with iodophor. After wiping the wound surface with normal saline, gently scrape the necrotic tissue on the surface of the wound with a dressing forceps. If there are large curls that cannot be scraped off, gently cut off the edges of the curls with a medical scissors. After flushing away the necrotic tissue with normal saline, cover the affected area with a medical absorbent cotton sheet, with the surrounding coverage area being 1 cm larger than the affected area. Pour the medicinal liquid of the present invention on the absorbent cotton. When the cotton sheet is soaked with the medicine and turns brown, wear medical gloves and gently press to make the absorbent cotton fully adhere to the wound surface. Gently squeeze the bulging areas and push them towards the edge to expel air bubbles so that the medicine can be better absorbed by the wound surface. After about 30 minutes, the absorbent cotton will change from the original brown to light brown and multiple bubbles will appear. If the exudate volume is large, pour the medicine again according to the above method. If there is almost no exudate, a dressing can be covered, and repeat the above process the next day for dressing change. Usually, once a day is enough. Under normal circumstances, for a wound surface with a diameter less than 5 cm, the dosage is 10 ml - 15 cm, and for a wound surface larger than 5 cm, 30 cm - 50 cm is required. In the case of a large amount of metabolic secretions, the number of usage times and the dosage can be increased as appropriate.

[0119] Curative effect judgment criteria: Refer to the curative effect criteria in the "Diagnostic and Curative Effect Criteria for Clinical Diseases of Traditional Chinese Medicine" promulgated by the State Administration of Traditional Chinese Medicine of China, and combine with clinical diagnosis and evaluation:

[0120] Cured: The wound surface epithelium is completely covered, the scar is firm, and there is no false healing phenomenon such as subcutaneous abscess.

[0121] Markedly effective: The reduction range of the wound surface area > 75%, the granulation tissue is fresh, and there is no purulent secretion

[0122] Improvement: The reduction range of the wound area is ≥ 25%, with no or a small amount of purulent secretion, and there is red granulation tissue. Ineffective: The reduction range of the wound area is < 25%, there is still purulent secretion, and accompanied by dark granulation tissue

[0123] Treatment outcome:

[0124] Negative conversion rate of wound surface bacteria culture: Before the experiment and on the 7th, 10th, 14th, and 21st days after treatment, the wound surface secretion bacteria culture was performed on the patients' wound surfaces once respectively, and the negative conversion rate of bacteria culture was calculated. The formula is negative conversion rate of bacteria = (number of cases with negative conversion of wound surface bacteria culture after medication / number of cases with positive bacteria culture before medication) × 100%. A total of 68 wound surfaces had bacterial infections before treatment. After 7 days of treatment, 42 cases had negative bacteria conversion, and the negative conversion rate was 61.76%. After 10 days of treatment, a total of 58 cases had negative bacteria conversion, and the negative conversion rate was 85.29%. After 14 days of treatment, a total of 60 cases had negative bacteria conversion, and the negative conversion rate was 88.23%. After 21 days of treatment, a total of 63 cases had negative bacteria conversion, and the negative conversion rate was 92.65%.

[0125] The experimental results show that the traditional Chinese medicine composition of the present invention has a good inhibitory effect on bacteria in tumor wound surfaces and has the effect of accelerating the healing of wound surface damage.

[0126] Therapeutic effect: After dressing changes for 21 days on 68 tumor wound surfaces that were difficult to heal with the traditional Chinese medicine composition of the present invention, the therapeutic effect is shown in Table 1. The effective rate is the sum of the cure rate, marked effective rate, and improvement rate.

[0127] Table 3 Therapeutic effect results after treatment with the traditional Chinese medicine composition of the present invention [n(%)]

[0128] Total cases Cured Markedly effective Improved Ineffective 68 19(27.94％) 48(70.58％) 1(1.47％) 0(0％)

[0129] It can be seen from the experimental results that the effective rate of the traditional Chinese medicine composition of the present invention can reach 100%.

[0130] Healing time of tumor wound surface damage: After 21 days, dressing changes were continued on 68 wound surfaces with tumor wound surface damage until the wound surface healed. Finally, all wound surfaces healed, and the average healing time was 25.17 days ± 9.16 days.

[0131] Conclusion: The experimental results show that the traditional Chinese medicine composition of the present invention has obvious effects on tumor wound surfaces that are difficult to heal.

[0132] III. Typical cases

[0133] Typical case 1: A patient with oropharyngeal cancer

[0134] Patient gender: male; age: 65 years old, oropharyngeal cancer patient for 5 years, with diabetes, hypertension, and postoperative radiotherapy. The wound surface has purulent secretions and a foul odor; the wound surface is wet compress with the traditional Chinese medicine combined liquid of Example 1 of the present invention, 90 ml per day for the first three days, once a day, and then reduced to 60 ml per day, once a day, as Figure 1 shown. After using the traditional Chinese medicine combined liquid of Example 1 of the present invention for four days, it can be clearly seen that the inflammatory bacterial film on the wound surface falls off, the purulent secretions are reduced by more than 80% compared with before use, the peculiar smell is almost gone, the wound surface is significantly reduced to 25% of the original wound surface size, and new granulation tissue appears inside the wound surface.

[0135] Typical case 2: A patient with lymphoma rupture

[0136] Patient gender: male; age: 55 years old, without underlying diseases, newly diagnosed case. Severe breathing obstruction leading to tracheotomy, need to gasp with open mouth, high fever, severe pain with restricted head movement, swollen and deformed neck, everted rupture surface, a large amount of tissue fluid overflowing inside (at least 5 large packages of thick degreased cotton yarn per day for the largest package), exposed tumor tissue, cell swelling and induration, rapid growth, and foul smell continuously released with breathing. The wound surface is 22*17 cm, as Figure 2 shown in the left figure on August 9, 2022. Starting from August 9, 2022, the wound surface is wet compress with the traditional Chinese medicine combined liquid of Example 1 of the present invention, 60 ml is taken orally every day, 30 ml each time, twice a day, and 150 ml is used for body surface wet compress. There is a large amount of exudate with blood every day. After continuous use for 21 days until September 1, 2022, as Figure 2 shown in the right figure, the wound surface is significantly reduced to 20% of the original wound surface, the peculiar smell is reduced, the wound surface area is 8*5 cm, the patient can turn the head slightly, breathe significantly smoother, can close the mouth and breathe with the nose, can walk slowly on the ground, and the body temperature is normal.

[0137] Typical case 3: A patient with aortic hemangioma

[0138] Patient gender: male; age: 72 years old. Had a vascular stent placed three years ago, weighs less than 100 catties, has severe anemia, and has a history of aortic hemangioma for more than 7 years. Ultrasonography shows 50% vascular compression, multiple breakpoints on the tumor epidermis, continuous oozing of venous blood from the tumor breakpoints, multiple purpuras on the body, unable to undergo surgery or radiotherapy. Due to possible uncontrollable bleeding from tumor rupture and infection, it is not recommended to use targeted drug resistance. Starting from October 19, 2022, the traditional Chinese medicine combined liquid of Example 1 of the present invention is used for body surface wet compress, 150 ml per day, initially twice a day. After three days, the dosage is gradually reduced according to the wound surface condition, as Figure 3 shown. After two months of treatment, the wound surface is completely closed. During the treatment period, the patient received blood transfusions 3 times, 800 - 1200 ml each time. The residual tumor tissue metabolized is necrotic tissue, and no tumor was detected after the wound surface healed.

[0139] Typical case 4: Breast tumor patient

[0140] Patient gender: female; age: 32 years old, married but childless, diagnosed for more than 4 years, no other medical history, chemotherapy side effects caused tumor rupture, severe pain, sinus fistula, strong rancid odor, hardening of the entire chest, rib pain, pain when walking, and inability to take care of oneself. On October 12, 2023, the Chinese medicine combination liquid of Example 1 of the present invention was used for wet compresses, 180 ml of wet compresses per day on the body surface, one-time use, the redness and swelling of the wound surface was effectively controlled, the odor was significantly reduced, the wound surface became dry, the bacterial film fell off, and the new granulation tissue was exposed. After 27 days of use, as shown Figure 4 The wound surface epidermis healed obviously.

[0141] Typical case 5: Lung cancer patient

[0142] Patient gender: female; age: 50 years old, sensitive constitution, multiple allergic reactions, diabetic patient, lung cancer for more than 5 years, targeted drugs and PDI induce systemic dermatitis, multiple ulcers with pus and water, swelling of the whole body, dry cracks and bleeding on the wound surface when the body moves, according to the patient's condition, it is recommended to take 60ml orally, once a day, and apply wet compresses on the key ulcers. The total dosage of the Chinese medicine combination liquid of Example 1 of the present invention is 120ml for four seriously affected areas, and wet compresses once a day. The effect is obvious. Within 7 days of use, the new granulation tissue on the wound surface reaches more than 85%, there is no purulent secretion, no odor and exudate, Figure 5 This is a comparison of the wound before and after three weeks of use.

[0143] Typical case 6: Patient with ruptured axillary lymph node tumor

[0144] Patient gender: female; age: 58 years old, weak and sick, three high patients, diagnosed with breast cancer for more than 8 years, clothes were worn out by friction, body surface wet compresses were used in a dosage of 60 ml per day, one-time use, after one day of wet compressing with the Chinese medicine combination liquid of Example 1 of the present invention, as shown in the figure Figure 5 It can be seen that the inflammatory bacterial film on the wound surface is reduced by more than 50%, the odor becomes lighter, the granulation tissue around the wound is exposed, and the bottom of the wound gradually appears. The patient's pain is significantly reduced, he can slightly lift his arms, and the swelling of the chest and shoulders is significantly reduced.

[0145] Typical case 7: Patient with advanced vulvar cancer

[0146] Patient gender: female; age: 42 years old, no previous medical history, first-diagnosed patient, during chemotherapy combined with radiotherapy, all indicators deteriorated, high fever persisted, waking up once every 10 minutes of sleep, basically no sleep, advanced stage of vulvar cancer, oral administration of the Chinese medicine combination liquid of Example 1 of the present invention 60 ml each time, once a day, external application of the Chinese medicine combination liquid of Example 1 of the present invention 30 ml once a day, after one month of use, the tumor lesions healed by more than 90%, and the normal values ​​of blood test indicators returned to normal.

[0147] Typical Case 8: A patient in the advanced stage of hemangioma

[0148] Patient's gender: male; age: 46 years old. The patient is a newly diagnosed case with no previous medical history and has been exposed to radiation sources. He is in the advanced stage of hemangioma. The damaged wound surface and the entire front chest were wet compress with the traditional Chinese medicine combined liquid of Example 1 of the present invention, with a daily dosage of 150 ml. During the use of the traditional Chinese medicine combined liquid of Example 1 of the present invention, a large amount of tissue fluid metabolism can reach more than 800 ml per day. On the third day of use, the damaged wound surface was completely exposed, and the bottom and surrounding tissues could be clearly seen, as Figure 6 shown. After 10 days of use, the redness, swelling and induration of the chest were significantly relieved, and the damaged surface was reduced to 50% of the original lesion. The skin became white and soft, returning to its normal color. The patient felt relaxed, the pain was reduced, there was basically no bleeding, and he began to have an appetite and could walk normally.

[0149] Typical Case 9: Advanced invasive ductal carcinoma

[0150] Patient's gender: female; age: 46 years old. With no previous medical history, she has been conservatively treated for 5 years of diagnosed invasive ductal carcinoma. Chemotherapy was suspended due to tumor rupture. During the use of the traditional Chinese medicine combined liquid of Example 1 of the present invention, the mammary ducts were gradually disconnected, and the tumor substances were completely metabolized out of the body. Two pieces of tumor tissues fell off, one was 6 cm * 3.5 cm and the other was 8.2 cm * 5 cm. Both were detected as tumor tissues. After 40 days of review, ultrasound biopsy, blood test, B-ultrasound all showed inflammation, and no tumor substances were detected by magnetic resonance imaging for tumor signals. The review report in Beijing showed breast hyperplasia. Once a day, 90 ml was perfused. Lie flat and wait for the medicine to completely penetrate into the subcutaneous tissue before getting up. As the wound surface shrinks, the dosage of the medicine gradually decreases.

[0151] Typical Case 10: Advanced triple-negative breast cancer

[0152] Patient's gender: female; age: 50 years old; with metastases to the head, scapula, collarbone, ankle bone, lungs, and cervical lymph nodes. With no previous medical history, she is a patient with artificial liver, newly diagnosed and treated. She has multi-organ failure of the heart and lungs, and there are a large number of damaged points on the chest. The blood oxygen is 80. The patient is in a coma with delirium, anemia, and general edema. During the use of the traditional Chinese medicine combined liquid of Example 1 of the present invention, 60 ml was taken orally, and 150 ml of the traditional Chinese medicine combined liquid of Example 1 of the present invention was wet compress on the outside of the front chest. After one week, the blood test indicators recovered. The patient's edema subsided, and the wound surface healed to more than 90% of the original wound surface. The patient did not need to take painkillers and could enter deep sleep. The appetite improved, and she could sit up and eat. The overall condition was significantly improved.

[0153] A traditional Chinese medicine composition for the treatment of tumor rupture repair of the present invention realizes multi-effect combined treatment through the scientific compatibility of honeysuckle, dandelion, and noni fruit, significantly shortens the healing time, reduces the risk of infection, and provides a safe and convenient treatment option for tumor patients.

[0154] As described above, it is only the preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A Chinese medicine composition for the treatment of tumor damage repair, characterized in that: The composition is composed of the following raw materials in parts by weight: 10-25 parts of honeysuckle, 6-15 parts of dandelions, and 15-40 parts of noni fruit.

2. The composition according to claim 1, characterized in that The composition is composed of the following raw materials in parts by weight: 15-20 parts of honeysuckle, 9-12 parts of dandelions, and 18-30 parts of noni fruit.

3. The composition according to claim 2, characterized in that The composition is composed of the following raw materials in parts by weight: 20 parts of honeysuckle, 12 parts of dandelions, and 30 parts of noni fruit.

4. The method for preparing the composition according to any one of claims 1 to 2, characterized in that: The preparation method comprises the following steps: a. Weigh the raw materials of each weight ratio; b. Use a Chinese medicine decoction pot and preheat it on low heat for 8-12 minutes; c. Cut honeysuckle, dandelion and noni fruit into segments, put them into a preheated Chinese medicine decoction pot, then add 4-6 times the weight of the raw materials of purified water for the first time, then stir and soak for 60-90 minutes; d. Put the Chinese medicine decoction pot with honeysuckle, dandelion and noni fruit in it, boil the water with high heat, then simmer for 30-60 minutes with low heat, filter out the juice and residue with a strainer, and let it cool temporarily; e. The cooled Chinese medicine decoction pot in c is decocted for the second time. The second decoction is added with 3-5 times the weight of the remaining residue after filtration in d. The water is boiled with high heat first, then simmered with low heat for 20-30 minutes, and then the juice and residue are filtered out with a filter, and then cooled temporarily; f. The cooled Chinese medicine decoction pot in d is decocted for the third time. The third decoction is added with 2-3 times the weight of the remaining residue after filtration in e. The water is boiled with high heat first, then simmered with low heat for 20-30 minutes, and then the juice and residue are filtered out with a filter, and then cooled temporarily; g. Filter the juice from d, e, and f with a filter, mix them, and pour them into the Chinese medicine decoction pot. Stir continuously and heat on low heat for 8-12 minutes to concentrate to the required amount. Filter the juice with a filter, cool and package it into aqueous preparations.

5. The method for preparing the composition according to claim 3, characterized in that: In step a, select clean, impurity-free and mildew-free honeysuckle and dandelion. Select the noni fruit that is 80% ripe. Slice the noni fruit, dry it naturally in the shade, then clean it and set aside.

6. The preparation according to claim 3, characterized in that Its usage includes oral administration, wet compress, application, infusion or gargle.

7. Use of the Chinese medicine composition according to claim 3 in the preparation of a drug for treating and repairing damaged tumors on the body surface, wherein the drug is used to inhibit tumor growth.

8. The use according to claim 3, characterized in that: The tumor damage is a damaged wound surface of lung cancer, lymphoma, breast tumor, oropharyngeal cancer, melanoma, vulvar cancer, cervical cancer, lower rectal cancer, hemangioma, epithelial cell cancer or osteosarcoma.

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