Compound Anti-tumor traditional chinese medicine composition, and preparation method therefor and use thereof

Abstract

A compound anti-tumor traditional Chinese medicine composition, and a preparation method therefor and the use thereof. The compound anti-tumor traditional Chinese medicine composition comprises the following components in parts by weight: 300-600 parts of astragali radix, 80-120 parts of red ginseng, 4-10 parts of blister beetle and 1-4 parts of bufonis venenum. The combination of these components has the effects of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, softening hardness to remove stasis, and strengthening body resistance to eliminate pathogenic factors.

Description

A compound anti-tumor Chinese medicine composition and its preparation method and application

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on February 26, 2024, with application number 202410207968.5 and invention name “A compound anti-tumor Chinese medicine composition, its preparation method and application”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a compound anti-tumor traditional Chinese medicine composition and its preparation method and application. Background Art

[0003] At present, there are relatively few types of traditional Chinese medicine anti-tumor preparations, and most of them have many limitations such as complex medication methods and poor efficacy. Therefore, they are difficult to promote and have low public recognition. According to the dosage form, anti-tumor traditional Chinese medicines are roughly divided into two types: injections and capsules. Similar traditional Chinese medicine preparations for anti-tumor Chinese medicine currently on the market include Delisheng injection and Aidi injection. Both are injections that enter the blood directly and are highly toxic. Side effects such as vascular irritation (local pain at the injection site), and multi-organ / visceral toxicity such as heart (palpitations, facial flushing), kidney (hematuria), and intestine (nausea, vomiting, dizziness, and numbness in the mouth) limit their use by patients. Injections with fewer side effects, such as Aidi injection, have lower drug content, so their efficacy is limited.

[0004] Traditional Chinese medicine anti-tumor capsules, such as compound mylabris capsules and cinobacterial capsules, have minimal toxicity and side effects, are easy to use, and have a wide range of applications. However, compound mylabris capsules use multiple components, resulting in a complex formulation, while cinobacterial capsules have a single ingredient, resulting in limited therapeutic efficacy. Therefore, a drug with minimal side effects, ease of use, and significant anti-cancer efficacy is urgently needed. Summary of the Invention

[0005] The present application provides a compound anti-tumor Chinese medicine composition, a preparation method and an application thereof. The Chinese medicine composition has the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, softening and dispersing nodules, strengthening the body and eliminating evil, has little toxic and side effects, and can be used alone for primary tumors.

[0006] To solve the above technical problems, this application provides the following technical solutions:

[0007] The present application provides a compound anti-tumor Chinese medicine composition, which comprises the following components in parts by weight: 300-600 parts of astragalus, 80-120 parts of red ginseng, 4-10 parts of mylabris, and 1-4 parts of toad venom.

[0008] The present application provides a preparation method of the compound anti-tumor Chinese medicine composition, comprising the following steps: crushing red ginseng, astragalus and toad venom separately to obtain red ginseng powder, astragalus powder and toad venom powder; mixing mylabris with water, heating and refluxing for extraction, filtering, concentrating, adding red ginseng powder, astragalus powder and toad venom powder, mixing evenly, drying and crushing.

[0009] The present application also provides a compound anti-tumor Chinese medicine capsule, which is obtained by putting the compound anti-tumor Chinese medicine composition obtained by the preparation method into a capsule.

[0010] The present application also provides the use of the compound anti-tumor Chinese medicine composition or the compound anti-tumor Chinese medicine composition obtained by the preparation method or the compound anti-tumor Chinese medicine capsule in the preparation of anti-cancer products. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a flow chart of the preparation process of compound anti-tumor Chinese medicine capsules.

[0012] Figure 2 shows the changes in tumor volume and tumor markers in Case 1 after taking the compound anti-tumor Chinese medicine capsule.

[0013] Figure 3 shows the changes in tumor volume and tumor markers in Case 2 after taking the compound anti-tumor Chinese medicine capsule.

[0014] Figure 4 shows the changes in tumor volume and tumor markers in Case 3 after taking the compound anti-tumor Chinese medicine capsule. DETAILED DESCRIPTION

[0015] The present application provides a compound anti-tumor Chinese medicine composition, comprising the following components by weight: 300-600 parts of Astragalus, 80-120 parts of Red Ginseng, 4-10 parts of Mylabris, and 1-4 parts of Venenum Bufon. The compound anti-tumor Chinese medicine composition described herein preferably comprises the following components by weight: 350-550 parts of Astragalus, 90-110 parts of Red Ginseng, 5-9 parts of Mylabris, and 2-3.5 parts of Venenum Bufon. It further preferably comprises the following components by weight: 400 parts of Astragalus, 100 parts of Red Ginseng, 6 parts of Mylabris, and 3 parts of Venenum Bufon. The Astragalus, Red Ginseng, Mylabris, and Venenum Bufon described herein were purchased in accordance with national standards for traditional Chinese medicine.

[0016] In the present application, the blister beetle is pungent and hot, highly toxic, promotes blood circulation, removes blood stasis, attacks toxins and disperses nodules; the toad venom is pungent and warm, toxic, detoxifies, reduces swelling and relieves pain; these two flavors are combined to dispel evil and are the monarch medicine; the red ginseng is sweet and slightly bitter, neutral in nature, greatly replenishes vital energy, strengthens the spleen and replenishes qi; the astragalus is sweet and warm, and when combined with red ginseng, the function of replenishing qi and strengthening the body is enhanced, and it is the minister medicine; the monarch and minister work together, and when qi is strong and essence and blood are produced, the body is strengthened and nourished, and when true qi is replenished, qi is strengthened and blood circulates; all the medicines are used together to strengthen the body without clinging to evil, and to eliminate evil without hurting the body, and together play the role of replenishing qi and strengthening the body, eliminating nausea and vomiting, and detoxifying and relieving pain, and have the effects of clearing away heat and toxins, promoting blood circulation and removing blood stasis, softening and dispersing nodules, and strengthening the body and eliminating evil.

[0017] The present application provides a preparation method of the compound anti-tumor Chinese medicine composition, comprising the following steps: crushing red ginseng, astragalus and toad venom separately to obtain red ginseng powder, astragalus powder and toad venom powder; mixing mylabris with water, heating and refluxing for extraction, filtering, concentrating, adding red ginseng powder, astragalus powder and toad venom powder, mixing evenly, drying and crushing.

[0018] In this application, red ginseng is cleaned, sorted, impurities removed, air-dried, sliced, crushed, sieved, and weighed. The red ginseng described in this application is dried at 55-65°C for 5-7 hours, allowed to stand at room temperature, crushed into a fine powder, and sieved through an 80-120 mesh sieve to obtain the red ginseng powder. The red ginseng drying temperature described in this application is preferably 57-63°C, the drying time is preferably 5.5-6.5 hours, and the fine powder is preferably sieved through a 90-100 mesh sieve.

[0019] In this application, the astragalus root needs to be cleaned, selected, impurities removed, dried, sliced, crushed, sieved, and weighed. The astragalus root described in this application is dried at 55-65°C for 5-7 hours, placed at room temperature, crushed into a fine powder, and passed through an 80-120 mesh sieve to obtain the astragalus root powder. The astragalus root described in this application is preferably dried at a temperature of 57-63°C for 5.5-6.5 hours, and the fine powder is preferably sieved through a 90-100 mesh sieve.

[0020] In this application, the toad venom is selected, impurities are removed, crushed, sieved, and weighed. The toad venom described in this application is crushed into a fine powder and passed through an 80-120 mesh sieve to obtain the toad venom powder. The fine powder is preferably sieved to a 100 mesh.

[0021] In this application, the mylabris blister beetles need to be selected, impurities removed, crushed, sieved, and weighed. The mylabris blister beetles described in this application are crushed into coarse powder, passed through a 15-25 mesh sieve, weighed, and 35-45 times the weight of the mylabris blister powder is added with water. The mixture is heated and refluxed for 1-3 times, each time for 1.5-2.5 hours. The reflux liquid is combined and filtered through an 80-120 mesh sieve. The filtrate is concentrated to 1 / 4-3 / 4 of the total volume to obtain a mylabris blister concentrate. The coarse powder described in this application is preferably sieved with a mesh size of 18-23 mesh. The amount of water added described in this application is preferably 38-43 times the weight of the mylabris blister powder.

[0022] In the present application, the red ginseng powder, astragalus powder and toad venom powder in the aforementioned parts by weight are uniformly mixed with the above-mentioned mylabris concentrate, dried at 55-65° C., crushed, and passed through a 10-30 mesh sieve to obtain a compound anti-tumor Chinese medicine composition.

[0023] The present application also provides a compound anti-tumor Chinese medicine capsule, which is prepared by putting the compound anti-tumor Chinese medicine composition into a capsule. The compound anti-tumor Chinese medicine capsule described in the present application has a specification of 0.3-0.6g per capsule, preferably 0.4g, and 10 capsules per plate.

[0024] This application also provides the use of the compound anti-tumor Chinese medicine composition, or the compound anti-tumor Chinese medicine composition obtained by the preparation method, or the compound anti-tumor Chinese medicine capsule in the preparation of anti-cancer products. The cancers described in this application include digestive system cancers such as esophageal cancer, gastric cancer, intestinal cancer, liver cancer, and pancreatic cancer; respiratory system cancers such as lung cancer; and adenocarcinomas insensitive to radiotherapy and chemotherapy. The anti-tumor Chinese medicine composition and anti-tumor Chinese medicine capsule described in this application can also be used for patients who are unable to undergo radiotherapy or chemotherapy, patients who require combination therapy with radiotherapy or chemotherapy, and patients who require conservative treatment after radiotherapy or chemotherapy.

[0025] In the present application, the application method of the compound anti-tumor Chinese medicine capsule is as follows: two capsules at a time, three times a day; take after meals, one course of treatment is 45 days or follow the doctor's advice.

[0026] In the present application, the compound anti-tumor Chinese medicine composition can also be prepared into tablets, powders, pills, granules, and suspensions.

[0027] This application has the following beneficial effects:

[0028] This application is the first to compound mylabris, toad venom, astragalus and red ginseng to prepare an anticancer drug. In this Chinese medicine composition, mylabris is pungent and hot, highly toxic, promotes blood circulation and removes blood stasis, and attacks toxins and disperses stagnation. Toad venom is pungent and warm, toxic, and detoxifies, reduces swelling and relieves pain. These two flavors are compounded to dispel pathogenic factors and are the monarch drug; red ginseng is sweet and slightly bitter, has a neutral nature, greatly replenishes vital energy, strengthens the spleen and replenishes qi, and astragalus is sweet and warm. When combined with red ginseng, it can increase the effect of replenishing qi and strengthening the body, and is the minister drug; this monarch and minister work together, and when qi is strong and blood is generated, the body is strengthened and the true qi is replenished, then qi is strong and blood is circulated. The various drugs in this application's Chinese medicine composition are combined to strengthen the body without clinging to the pathogenic factors, and to dispel the pathogenic factors without hurting the body, and together they play the functions of replenishing qi and strengthening the body, eliminating paralysis and dispersing stagnation, and detoxifying and relieving pain. It has the effects of clearing away heat and toxic substances, promoting blood circulation and removing blood stasis, softening and dispersing stagnation, and strengthening the body and eliminating pathogenic factors. Based on the combination of attacking and replenishing, strengthening the body and eliminating pathogenic factors has become an important rule for the clinical treatment of malignant tumors, especially advanced tumors. The composition of the Chinese medicine composition of the present application can embody the TCM treatment principle of "strengthening the body's resistance and eliminating pathogenic factors" and has a solid TCM clinical theory.

[0029] The Chinese medicine composition of the present application has rationally selected ingredients, excellent compatibility, is easy to take, has good applicability, and is easy to promote. At the same time, the Chinese medicine composition has few toxic and side effects and can be used alone for primary tumors or in combination with radiotherapy or chemotherapy drugs. While increasing the therapeutic effect, it can also reduce the toxic and side effects of radiotherapy and chemotherapy drugs on patients.

[0030] The Chinese medicine composition of the present application is suitable for a variety of cancers and patients, such as respiratory system cancer: lung cancer; adenocarcinoma that is insensitive to radiotherapy and chemotherapy; digestive system cancer: esophageal cancer, gastric cancer, intestinal cancer, liver cancer, pancreatic cancer; patients who cannot undergo radiotherapy and chemotherapy; patients who need combined medication during radiotherapy and chemotherapy; and patients receiving conservative treatment after radiotherapy and chemotherapy.

[0031] In this application, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0032] The present application will be further described below with reference to the accompanying drawings and embodiments.

[0033] Unless otherwise specified, the methods used in the following examples are all conventional methods.

[0034] Example 1

[0035] A compound anti-tumor traditional Chinese medicine composition is prepared from the following components in parts by weight: 400 parts of astragalus, 100 parts of red ginseng, 6 parts of mylabris, and 3 parts of toad venom.

[0036] A method for preparing a compound anti-tumor Chinese medicine composition comprises the following steps:

[0037] (1) Dry red ginseng at 60°C for 6 hours, place it at room temperature, and then grind it into fine powder. Then, pass it through a 100-mesh sieve to obtain red ginseng powder.

[0038] (2) Dry the Astragalus root at 60°C for 6 h, place it at room temperature, and then grind it into fine powder. Then, pass it through a 100-mesh sieve to obtain the Astragalus root powder.

[0039] (3) Grind the toad venom into fine powder and pass it through a 100-mesh sieve to obtain the toad venom powder;

[0040] (4) The blister beetles are crushed into coarse powder, passed through a 20-mesh sieve, weighed according to the above weight parts, and 40 times the weight of the blister beetle powder is added with water, and the mixture is heated and refluxed for extraction twice, each time for 2 hours. The reflux liquid is combined and filtered through a 100-mesh sieve. The filtrate is concentrated to 1 / 2 of the total volume, and red ginseng powder, astragalus powder, and toad venom powder are added according to the above weight parts, mixed evenly, dried at 60°C, crushed, and passed through a 20-mesh sieve to obtain the product.

[0041] A preparation method of a compound anti-tumor Chinese medicine capsule comprises the following steps: the compound anti-tumor Chinese medicine composition prepared in the above steps is filled into capsules, wherein the capsule specification is 0.4g per capsule and 10 capsules per plate.

[0042] Example 2

[0043] A compound anti-tumor traditional Chinese medicine composition is prepared from the following components in parts by weight: 300 parts of astragalus, 80 parts of red ginseng, 4 parts of mylabris, and 1 part of toad venom.

[0044] A method for preparing a compound anti-tumor Chinese medicine composition comprises the following steps:

[0045] (1) Red ginseng was dried at 65°C for 5 h, then ground into fine powder after being allowed to stand at room temperature, and passed through a 120-mesh sieve to obtain red ginseng powder;

[0046] (2) Dry the Astragalus root at 65°C for 5 h, place it at room temperature, and grind it into fine powder. Then, pass it through a 120-mesh sieve to obtain the Astragalus root powder.

[0047] (3) Grind the toad venom into fine powder and pass it through a 120-mesh sieve to obtain the toad venom powder;

[0048] (4) The blister beetles are crushed into coarse powder, passed through a 25-mesh sieve, weighed according to the above weight parts, and 45 times the weight of the blister beetle powder is added with water, and the mixture is heated and refluxed for extraction 3 times, each time for 2.5 hours. The reflux liquid is combined and filtered through a 100-mesh sieve. The filtrate is concentrated to 3 / 4 of the total volume, and red ginseng powder, astragalus powder, and toad venom powder are added according to the above weight parts, mixed evenly, dried at 65° C., crushed, and passed through a 25-mesh sieve to obtain the product.

[0049] A preparation method of a compound anti-tumor Chinese medicine capsule comprises the following steps: the compound anti-tumor Chinese medicine composition prepared in the above steps is filled into capsules, wherein the capsule specification is 0.4g per capsule and 10 capsules per plate.

[0050] Example 3

[0051] A compound anti-tumor traditional Chinese medicine composition is prepared from the following components in parts by weight: 600 parts of astragalus, 120 parts of red ginseng, 10 parts of mylabris, and 4 parts of toad venom.

[0052] A method for preparing a compound anti-tumor Chinese medicine composition comprises the following steps:

[0053] (1) Red ginseng was dried at 55°C for 7 h, allowed to stand at room temperature, and then ground into fine powder. The powder was then passed through an 80-mesh sieve to obtain red ginseng powder.

[0054] (2) Dry the Astragalus root at 55°C for 7 h, place it at room temperature, grind it into fine powder, and pass it through an 80-mesh sieve to obtain the Astragalus root powder;

[0055] (3) Grind the toad venom into fine powder and pass it through an 80-mesh sieve to obtain the toad venom powder;

[0056] (4) The blister beetles are crushed into coarse powder, passed through a 15-mesh sieve, weighed according to the above weight parts, and 35 times the weight of the blister beetle powder is added with water, and the mixture is heated under reflux and extracted once for 2.5 hours each time. The mixture is filtered through a 100-mesh sieve, and the filtrate is concentrated to 1 / 4 of the total volume. The red ginseng powder, astragalus powder, and toad venom powder are added according to the above weight parts, mixed evenly, dried at 55° C., crushed, and passed through a 15-mesh sieve to obtain the product.

[0057] A preparation method of a compound anti-tumor Chinese medicine capsule comprises the following steps: the compound anti-tumor Chinese medicine composition prepared in the above steps is filled into capsules, wherein the capsule specification is 0.4g per capsule and 10 capsules per plate.

[0058] Example 4 Clinical Application of Compound Anti-tumor Chinese Medicine Capsules

[0059] The compound anti-tumor Chinese medicine capsule prepared in Example 1 was applied to tumor patients, all of whom were patients who had poor treatment efficiency or had given up treatment, such as taking targeted drugs, surgery, chemotherapy, etc. The impact of the capsule on tumor patients was determined using tumor size, tumor marker values, chest tightness, headache and other adverse reactions as evaluation criteria. Currently, there are 12 patients included in this clinical application statistics, and the patients and their tumor types are shown in Table 1. The above statistics are part of the clinical trial statistics for the compound anti-tumor Chinese medicine capsule in this application, and related clinical trials are still ongoing and being compiled.

[0060] Table 1 Tumor patient information

[0061] After understanding the patient's condition, the compound anti-tumor Chinese medicine capsule prepared in Example 1 of this application was administered. Dosage: Two capsules three times daily after meals, for a 45-day course of treatment or as directed by a physician. The patient's condition was monitored, and their physical condition was inquired about. The patient was regularly examined at the hospital for relevant tumor markers. The final efficacy statistical results are shown in Table 2-5. Changes in tumor volume and tumor marker levels for selected patients are shown in Figure 2-4.

[0062] Among them, the judgment criteria are: significant: after taking the medicine, the primary tumor / metastatic lesion shrinks, the blood flow inside the tumor decreases or partially calcifies, the various indicators of tumor markers decrease, and the patient's physical condition improves.

[0063] Effectiveness: After taking the medicine, the tumor shows no signs of shrinking, but the cancer cells no longer spread, and common cancer symptoms disappear, that is, "living with tumor."

[0064] Ineffective: The condition does not improve significantly after taking the medicine and continues to worsen.

[0065] Table 2 Efficacy results

[0066] Table 3 Changes in tumor volume

[0067] Table 4 Tumor metastasis

[0068] Table 5 Changes of tumor markers

[0069] Example 5 Typical Cases

[0070] Lu, female, 66 years old, lung adenocarcinoma. It was discovered in 2019 at the West China Hospital of Sichuan University and underwent a puncture biopsy. The pathological report was lung adenocarcinoma. The patient gave up radiotherapy and chemotherapy, and the target matching successfully used targeted therapy. Two years later, due to the failure of targeted therapy and massive intrapulmonary hemorrhage during the first puncture biopsy, the patient was afraid of puncture biopsy for gene matching, even if the targeted drug was taken blindly. Subsequently, the tumor gradually increased in size, liver and kidney function was damaged, white blood cell count decreased, weight loss, loss of appetite, and peripheral neurogenic edema (both lower limbs and hands). On August 10, 2023, the patient began to take the compound anti-tumor Chinese medicine capsules prepared in Example 1 (Banchan Capsules), two capsules each time, three times a day, after meals. On August 27, 2023, when he woke up in the morning, he coughed up three pieces of milky yellow tissue (two pieces as big as corn kernels, and one and a half corn kernels). The patient suddenly felt that his breathing was unobstructed, and the original chest tightness and shortness of breath disappeared immediately. After one course of treatment (45 days), the primary lesion shrank, and tumor markers decreased. Scattered high-density shadows appeared within the primary lesion, indicating decreased blood flow and partial calcification. No enlargement of the hilar and mediastinal lymph nodes was observed, indicating metastasis. Increased translucency in both lungs indicated improved lung function (increased healthy lung tissue).

[0071] Ran, female, 52 years old, had bone metastasis of primary lung adenocarcinoma. As a medical staff member, she knew that lung adenocarcinoma was insensitive to radiotherapy and chemotherapy, and was preparing to do genetic testing to prepare for targeted treatment. During this period, she heard fellow patients talk about Banchan Capsules. When she visited the hospital, she had limited breathing, progressive weight loss, and fatigue. On September 10, 2023, she took the compound anti-tumor Chinese medicine capsules (Banchan Capsules) prepared in Example 1 orally, two capsules each time, three times a day, after meals. On the 9th day of medication, the CT report showed that the bone metastases had disappeared. On September 22, 2023, the CT scan was repeated, and the metastases had disappeared, the primary lesions in the lungs had shrunk, and she felt that her breathing was smooth, her physical strength had increased compared to before, and she had no discomfort. On October 26, 2023, the CT report showed multiple calcifications in the cancer body and multiple calcifications in the lungs. The second course of treatment was conducted on November 9, 2023. The patient reported no discomfort, could ride a bicycle for more than 10 kilometers at a time, and went to and from get off work normally. On January 20, 2024, the second course of treatment ended, and the examination report compared with the first course of treatment: the tumor had shrunk, and extensive calcification (scar tissue formed after tumor necrosis and absorption) and reduced blood flow appeared in the tumor.

[0072] Qiu, male, 40 years old, had multiple metastases of lung adenocarcinoma (liver, kidney, pancreas, bone, and intracranial), and portal vein cancer thrombus. The patient was diagnosed two years ago and underwent targeted therapy through gene matching in the first phase, but the subsequent treatment was ineffective, that is, he took it blindly. Later, the targeted drug failed, the side effects became more and more, and the primary lesions increased, the metastases increased, the pain worsened, and he could not bear it. After being introduced by a fellow patient, he took the compound anti-tumor Chinese medicine capsules (Banchan Capsules) prepared in Example 1 on October 6, 2023, two capsules each time, three times a day, after meals. On October 26, 2023, the patient complained: the main abdominal pain disappeared (hepatopancreatic metastasis), and the pain in the waist (multiple adrenal metastases) was relieved. On November 2, 2023, the CT report showed: the blood flow of the metastatic lesions in the liver decreased, the pancreatic metastases disappeared, and the vast majority of the adrenal metastases had disappeared. The tumor marker indicators showed a dozens of times increase (the tumor rapidly apoptosis over a large area, and a large amount of tumor markers enter the blood). The pain in the abdomen and waist completely disappeared.

[0073] Chen, female, 41 years old, had extensive metastasis after surgery for vascular invasive breast cancer. She underwent breast cancer surgery two years ago and did not receive chemotherapy after surgery. In July 2023, she was found to have recurrence on the surgical side, extensive metastasis in the contralateral breast, bilateral axilla, and lungs, pain and swelling in the bilateral breasts and axilla, persistent cough, and coughing up a large amount of white foamy sputum (extensive metastasis in the lungs), anemia, and edema. On July 10, 2023, she took the compound anti-tumor Chinese medicine capsule (Banchan Capsule) prepared in Example 1 orally, two capsules each time, three times a day, after meals. After a week, the pain was relieved, the lung metastasis caused severe cough, and the large amount of white foamy sputum was significantly relieved. She had good sleep and good diet. On August 19, 2023, Doppler color ultrasound showed: all the metastatic lymph nodes under the bilateral axilla disappeared, and only one nodule in the breast had scattered star-shaped blood flow; the metastatic lesions in the lungs were reduced, the cough was significantly relieved, and the white foamy sputum was significantly reduced; the patient felt that he had smooth breathing, good sleep, good appetite, and no pain or other discomfort. Liver and kidney function and blood routine tests were all normal. On January 17, 2024, the patient's tumor continued to shrink, calcification foci increased, and lung metastases decreased. No other discomfort symptoms were reported during this period.

[0074] Chen, female, 73 years old, diffuse large B-cell lymphoma with extensive metastasis. The pathology report from the Second Affiliated Hospital of Chengdu Medical College, Nuclear Industry 416 Hospital on August 8, 2023 indicated: "Abdominal cavity mass" puncture biopsy, diffuse large B-cell lymphoma, because the body could not tolerate it, she voluntarily gave up treatment. On November 1, 2023, she took the compound anti-tumor Chinese medicine capsules (Banchan Capsules) prepared in Example 1 orally, two capsules each time, three times a day, after meals. On December 8, 2023, the left and right pigeon egg-sized lymphomas in the neck, subcostal lymphoma, and left groin pigeon egg-sized lymphoma had completely disappeared, the abdominal pain symptoms had completely disappeared, weight had increased, the gray complexion turned rosy, and palpitations and fatigue had disappeared. On January 21, 2024, during the second course of treatment, the patient's right groin had shrunk by 60%, the pain had completely disappeared, weight had increased, and the diet and sleep were good.

[0075] Mr. Zhao, male, 66 years old, had moderately poorly differentiated adenocarcinoma of the intrahepatic bile duct. In mid-July 2023, he underwent partial liver resection + microwave ablation of liver tumor at the Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army in Beijing. On August 8, 2023, he received chemotherapy at the Central Hospital Affiliated to Fudan University in Shanghai. Because the patient had only taken the medicine for 3 days, he developed severe fatigue, nausea and vomiting, and was bedridden, so he gave up treatment. The CT report showed a 5.5×5.1cm space-occupying mass in the liver, which was twice as large as before the operation. On August 24, 2023, he took the compound anti-tumor Chinese medicine capsules prepared in Example 1 (Banchan Capsules) orally, two capsules each time, three times a day, after meals. On October 6, 2023, after one course of oral treatment, the patient's jaundice disappeared, abdominal distension disappeared, pain disappeared, his diet returned to normal, his sleep was good, his physical strength returned to normal, his weight increased, and he reported no abnormalities. On January 24, 2024, the second course of treatment ended, and the reexamination report showed that the tumor had shrunk to 2.5×4.2cm, the peritoneal metastasis had disappeared, and all tumor markers turned negative.

[0076] The above is only a preferred embodiment of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications should also be regarded as the scope of protection of the present application.

Claims

1. A compound anti-tumor Chinese medicine composition, characterized in that: The compound anti-tumor traditional Chinese medicine composition comprises the following components in parts by weight: 300-600 parts of astragalus, 80-120 parts of red ginseng, 4-10 parts of mylabris, and 1-4 parts of toad venom.

2. The method for preparing the compound anti-tumor Chinese medicine composition according to claim 1, wherein: The method comprises the following steps: crushing red ginseng, astragalus and toad venom separately to obtain red ginseng powder, astragalus powder and toad venom powder; mixing mylabris with water, heating and refluxing for extraction, filtering, concentrating, adding red ginseng powder, astragalus powder and toad venom powder, mixing evenly, drying and crushing.

3. The preparation method according to claim 2, wherein The red ginseng and astragalus root need to be dried at 55-65° C. for 5-7 hours before being crushed and then placed at room temperature.

4. The preparation method according to claim 2, wherein The crushed red ginseng, astragalus and toad venom are passed through an 80-120 mesh sieve.

5. The preparation method according to claim 2, wherein Before mixing with water, the blister beetles need to be crushed into a coarse powder and passed through a 15-25 mesh sieve.

6. The preparation method according to claim 2, wherein The amount of water added is 35 to 45 times the weight of the mylabris.

7. The preparation method according to claim 2, wherein The extraction times of heating and reflux are 1 to 3 times, each time for 1.5 to 2.5 hours.

8. The preparation method according to claim 2, wherein The concentration is to 1 / 4 to 3 / 4 of the total volume.

9. A compound anti-tumor Chinese medicine capsule, characterized in that: The compound anti-tumor Chinese medicine composition obtained by the preparation method according to any one of claims 2 to 8 is put into capsules to obtain the product.

10. Use of the compound anti-tumor Chinese medicine composition according to claim 1, or the compound anti-tumor Chinese medicine composition obtained by the preparation method according to any one of claims 2 to 8, or the compound anti-tumor Chinese medicine capsule according to claim 9 in the preparation of anti-cancer products.

11. The use according to claim 10, characterized in that The cancer includes lung adenocarcinoma, liver cancer, ovarian cancer, pancreatic cancer, bone cancer, breast cancer, lymphoma, hepatobiliary cancer, stomach cancer or esophageal cancer.

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