Compound anti-tumor traditional Chinese medicine composition, and preparation method and use thereof

Abstract

Compound anti-tumour traditional Chinese medicine composition comprising in parts by weight: 300-600 parts of Radix Astragali, 80-120 parts of red ginseng, 4-10 parts of large blister beetle, and 1-4 parts of Venenum Bufonis. Preparation method of said composition comprising the steps: crushing the red ginseng, Radix Astragali and Venenum Bufonis to obtain powders of each; mixing the large blister beetle with water to allow heating reflux extraction, conducting filtration and concentration; mixing the concentrate obtained with the powders of red ginseng, Radix Astragali and Venenum Bufonis evenly; drying and crushing the obtained mixture. Compound anti-neoplastic traditional Chinese medicine capsule prepared by loading the composition prepared by said method into a capsule. Use of said compound anti-tumor traditional Chinese medicine composition, or of a compound anti-tumor traditional Chinese medicine composition prepared by said method, or of said capsule, in preparation of an anti-cancer product.

Description

TECHNICAL FIELD

[0001] The present disclosure belongs to the technical field of traditional Chinese medicine, and specifically relates to a compound anti-tumor traditional Chinese medicine composition, and a preparation method and use thereof. BACKGROUND

[0002] At present, there are relatively few types of traditional Chinese medicine-based antitumor preparations, and most of them have many limitations such as complex medication methods and poor efficacy. Therefore, such preparations are difficult to promote and have low public recognition. Anti-tumor traditional Chinese medicines can be roughly divided into two types based on dosage form: injections and capsules. Similar anti-tumor traditional Chinese medicine preparations currently on the market include Delisheng Injection and Aidi Injection, both of which are injections that enter the blood directly and are highly toxic. Side effects such as vascular irritation (local pain at the injection site), and multiple organ toxicity such as heart (palpitation and facial flushing), kidney (hematuria), and intestinal tract (nausea, vomiting, dizziness, and oral numbness) limit the use of drugs by patients. Injections with fewer side effects, such as the Aidi Injection, have lower drug content and therefore limited efficacy.

[0003] Anti-tumor traditional Chinese medicine capsules such as Compound Banmao Capsule and Huachansu Capsule have less toxic and side effects, are easy for patients to use, and show a wide range of applications. However, the Compound Banmao Capsule adopts more components and has a complex compatibility, while the Huachansu Capsule has a single ingredient and limited therapeutic effect. Therefore, there is an urgent need for a drug that has fewer side effects, is easy to use, and shows significant effects on cancer. SUMMARY

[0004] The present disclosure provides a compound anti-tumor traditional Chinese medicine composition, and a preparation method and use thereof. The traditional Chinese medicine composition has the effects of clearing away heat and removing toxicity, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, as well as strengthening body resistance to eliminate pathogenic factors, shows small toxic and side effects, and can be used alone for primary tumors.

[0005] To solve the above technical problems, the present disclosure provides the following technical solutions:

[0006] The present disclosure provides a compound anti-tumor traditional Chinese medicine composition, including the following components in parts by weight: 300 parts to 600 parts of Radix Astragali, 80 parts to 120 parts of red ginseng, 4 parts to 10 parts of large blister beetle, and 1 part to 4 parts of Venenum Bufonis.

[0007] The present disclosure further provides a preparation method of the compound antitumor traditional Chinese medicine composition, including the following steps: crushing the red ginseng, the Radix Astragali, and the Venenum Bufonis to obtain a red ginseng powder, a Radix Astragali powder, and a Venenum Bufonis powder; and mixing the large blister beetle with water to allow heating reflux extraction, conducting filtration and concentration, mixing an obtained concentrate with the red ginseng powder, the Radix Astragali powder, and the Venenum Bufonis powder evenly, and then drying and crushing an obtained mixture.

[0008] Preferably, the red ginseng and the Radix Astragali are dried at 55°C to 65°C for 5 h to 7 h and then allowed to cool to a room temperature before the crushing.

[0009] Preferably, the red ginseng, the Radix Astragali, and the Venenum Bufonis after the crushing are sieved through a sieve of 80 mesh to 120 mesh.

[0010] Preferably, the large blister beetle is crushed into a coarse powder and then sieved through a sieve of 15 mesh to 25 mesh before mixing with the water.

[0011] Preferably, the water is added at 35 to 45 times the parts by weight of the large blister beetle.

[0012] Preferably, the heating reflux extraction is conducted 1 to 3 times for 1.5 h to 2.5 h each time.

[0013] Preferably, the concentration is conducted to 1 / 4 to 3 / 4 of a total volume.

[0014] The present disclosure further provides a compound anti-tumor traditional Chinese medicine capsule prepared by loading a compound anti-tumor traditional Chinese medicine composition prepared by the preparation method into a capsule.

[0015] The present disclosure further provides use of the compound anti-tumor traditional Chinese medicine composition, or a compound anti-tumor traditional Chinese medicine composition prepared by the preparation method, or the compound anti-tumor traditional Chinese medicine capsule in preparation of an anti-cancer product.

[0016] Compared with the prior art, the present disclosure has the following beneficial effects:

[0017] In the present disclosure, for the first time large blister beetle, Venenum Bufonis, Radix Astragali, and red ginseng are compounded to prepare an anti-cancer traditional Chinese medicine composition. In the traditional Chinese medicine composition, the large blister beetle is pungent, hot, and highly toxic, and can activate blood circulation to remove blood stasis, attack toxins, and disperse nodules; the Venenum Bufonis is pungent, warm, and toxic, and can detoxify, reduce swelling, and relieve pain. These two components are compounded to dispel evil, and serve as a monarch drug. The red ginseng is sweet and slightly bitter, has a neutral nature, and greatly replenishes vital energy, strengthens the spleen, and replenishes qi; the Radix Astragali is sweet and warm, can be combined with the red ginseng to exert the functions of replenishing qi, strengthening the body, and increasing function, thus serving as a ministerial drug. The monarch and ministerial drugs work together, when the qi is strong and the essence and blood are produced, the body will be strengthened and the vital qi will be replenished, such that the qi can be strong and the blood flows. The various medicines in the traditional Chinese medicine composition are used together to strengthen the body without clinging to the evil, eliminate the evil without hurting the body, and play the role of invigorating qi and strengthening the body, eliminating foot sores and dispersing stasis, and detoxifying and relieving pain. The traditional Chinese medicine composition has the effects of clearing away heat and removing toxicity, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, as well as strengthening body resistance to eliminate pathogenic factors. The combination of attack and supplement, as well as strengthening body resistance to eliminate pathogenic factors has become an important principle in the clinical treatment of malignant tumors, especially advanced tumors. The formula of the traditional Chinese medicine composition can embody a treatment principle of "strengthening body resistance to eliminate pathogenic factors" in the traditional Chinese medicine, and has a solid clinical theory of the traditional Chinese medicine.

[0018] In the present disclosure, the traditional Chinese medicine composition has the advantages of reasonable selection of components, excellent compatibility, convenient administration, desirable applicability, and convenience for promotion. Meanwhile, the traditional Chinese medicine composition shows little toxic and side effects, can be used alone for primary tumors or in combination with radiotherapy and chemotherapy drugs; while increasing the therapeutic effect, the composition can also reduce the toxic and side effects of radiotherapy and chemotherapy drugs on patients.

[0019] In the present disclosure, the traditional Chinese medicine composition is suitable for a variety of cancers and patients, including respiratory system cancer: lung cancer; adenocarcinoma insensitive to radiotherapy and chemotherapy; patients with digestive system cancer: esophageal cancer, gastric cancer, intestinal cancer, liver cancer, and pancreatic cancer; patients who cannot undergo radiotherapy and chemotherapy; patients who need combined medication during radiotherapy and chemotherapy; and patients who receive conservative treatment after radiotherapy and chemotherapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 shows a flow chart of the preparation process of the compound anti-tumor traditional Chinese medicine capsule;

[0021] FIG. 2 shows the changes in tumor volume and tumor markers of Case 1 after taking the compound anti-tumor traditional Chinese medicine capsule;

[0022] FIG. 3 shows the changes in tumor volume and tumor markers of Case 2 after taking the compound anti-tumor traditional Chinese medicine capsule; and

[0023] FIG. 4 shows the changes in tumor volume and tumor markers of Case 3 after taking the compound anti-tumor traditional Chinese medicine capsule. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0024] The present disclosure provides a compound anti-tumor traditional Chinese medicine composition, including the following components in parts by weight: 300 parts to 600 parts of Radix Astragali, 80 parts to 120 parts of red ginseng, 4 parts to 10 parts of large blister beetle, and 1 part to 4 parts of Venenum Bufonis. In the present disclosure, the compound anti-tumor traditional Chinese medicine composition includes preferably the following components in parts by weight: 350 parts to 550 parts of Radix Astragali, 90 parts to 110 parts of red ginseng, 5 parts to 9 parts of large blister beetle, and 2 part to 3.5 parts of Venenum Bufonis, more preferably 400 parts of Radix Astragali, 100 parts of red ginseng, 6 parts of large blister beetle, and 3 parts of Venenum Bufonis. The Radix Astragali, red ginseng, large blister beetle, and Venenum Bufonis are purchased in accordance with the national standards for traditional Chinese medicine.

[0025] In the present disclosure, the large blister beetle is pungent, hot, and highly toxic, and can activate blood circulation to remove blood stasis, attack toxins, and disperse nodules; the Venenum Bufonis is pungent, warm, and toxic, and can detoxify, reduce swelling, and relieve pain. These two components are compounded to dispel evil, and serve as a monarch drug. The red ginseng is sweet and slightly bitter, has a neutral nature, and greatly replenishes vital energy, strengthens the spleen, and replenishes qi; the Radix Astragali is sweet and warm, can be combined with the red ginseng to exert the functions of replenishing qi, strengthening the body, and increasing function, thus serving as a ministerial drug. The monarch and ministerial drugs work together, when the qi is strong and the essence and blood are produced, the body will be strengthened and the vital qi will be replenished, such that the qi can be strong and the blood flows. The various medicines are used together to strengthen the body without clinging to the evil, eliminate the evil without hurting the body, and play the role of invigorating qi and strengthening the body, eliminating foot sores and dispersing stasis, and detoxifying and relieving pain. The traditional Chinese medicine composition has the effects of clearing away heat and removing toxicity, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, as well as strengthening body resistance to eliminate pathogenic factors.

[0026] The present disclosure further provides a preparation method of the compound antitumor traditional Chinese medicine composition, including the following steps: crushing the red ginseng, the Radix Astragali, and the Venenum Bufonis to obtain a red ginseng powder, a Radix Astragali powder, and a Venenum Bufonis powder; and mixing the large blister beetle with water to allow heating reflux extraction, conducting filtration and concentration, mixing an obtained concentrate with the red ginseng powder, the Radix Astragali powder, and the Venenum Bufonis powder evenly, and then drying and crushing an obtained mixture.

[0027] In the present disclosure, the red ginseng needs to be cleaned, selected, impurities removed, air-dried, sliced, crushed, sieved, and weighed. The red ginseng is dried at 55°C to 65°C for 5 h to 7 h, placed at room temperature and then crushed into a fine powder, and then passed through an 80-120 mesh sieve to obtain a red ginseng powder. The red ginseng is preferably dried at 57°C to 63°C for 5.5 h to 6.5 h, and the fine powder is preferably sieved through a 90-100 mesh sieve.

[0028] In the present disclosure, the Radix Astragali needs to be cleaned, selected, impurities removed, air-dried, sliced, crushed, sieved, and weighed. The Radix Astragali is dried at 55°C to 65°C for 5 h to 7 h, placed at room temperature and then crushed into a fine powder, and then passed through an 80-120 mesh sieve to obtain a Radix Astragali powder. The Radix Astragali is preferably dried at 57°C to 63°C for 5.5 h to 6.5 h, and the fine powder is preferably sieved through a 90-100 mesh sieve.

[0029] In the present disclosure, the Venenum Bufonis needs to be selected, impurities removed, crushed, sieved, and weighed. The Venenum Bufonis is crushed into a fine powder, and then passed through an 80-120 mesh sieve to obtain a Venenum Bufonis powder. The fine powder is preferably sieved through a 100 mesh sieve.

[0030] In the present disclosure, the large blister beetle needs to be selected, impurities removed, crushed, sieved, and weighed. The large blister beetle is crushed into a coarse powder, passed through a 15-25 mesh sieve, weighed, water is added at 35 to 45 times a weight of the large blister beetle powder, and a resulting mixture is subjected to heating reflux extraction 1 to 3 times, each time for 1.5 h to 2.5 h. The obtained reflux solutions are combined, filtered through an 80-120 mesh sieve, and a resulting filtrate is concentrated to 1 / 4 to 3 / 4 of a total volume to obtain a large blister beetle concentrate. The coarse powder is preferably sieved through an 18-23 mesh sieve. The water is added at preferably 38 to 43 times the weight of the large blister beetle powder.

[0031] In the present disclosure, the red ginseng powder, Radix Astragali powder, and Venenum Bufonis powder in parts by weight are uniformly mixed with the large blister beetle concentrate, dried at 55°C to 65°C, crushed, and then sieved through a 10-30 mesh sieve to obtain the compound anti-tumor traditional Chinese medicine composition.

[0032] The present disclosure further provides a compound anti-tumor traditional Chinese medicine capsule prepared by loading the compound anti-tumor traditional Chinese medicine composition into a capsule. In the present disclosure, the compound anti-tumor traditional Chinese medicine capsule has a specification of 0.3 g to 0.6 g per capsule, preferably 0.4 g, with 10 capsules per plate.

[0033] The present disclosure further provides use of the compound anti-tumor traditional Chinese medicine composition, or a compound anti-tumor traditional Chinese medicine composition prepared by the preparation method, or the compound anti-tumor traditional Chinese medicine capsule in preparation of an anti-cancer product. In the present disclosure, the cancer includes digestive system cancer: esophageal cancer, gastric cancer, intestinal cancer, liver cancer, and pancreatic cancer; respiratory system cancer: lung cancer; adenocarcinoma insensitive to radiotherapy and chemotherapy. The compound anti-tumor traditional Chinese medicine composition and the compound anti-tumor traditional Chinese medicine capsule can also be applied to patients who cannot undergo radiotherapy or chemotherapy, patients who need combined medication during radiotherapy or chemotherapy, and patients who receive conservative treatment after radiotherapy or chemotherapy.

[0034] In the present disclosure, an application method of the compound anti-turnor traditional Chinese medicine capsule is as follows: two capsules at one time, three times one day; taking after meals, a course of treatment of 45 d or as directed by a doctor.

[0035] In the present disclosure, the compound anti-tumor traditional Chinese medicine composition can also be prepared into a tablet, a powder, a pill, a granule, and a suspension.

[0036] In the present disclosure, unless otherwise specified, all raw material components are commercially available products well known to persons skilled in the art.

[0037] The technical solutions of the present disclosure will be clearly and completely described below with reference to the examples of the present disclosure. Apparently, the described examples are merely a part rather than all of the examples of the present disclosure. All other examples obtained by those skilled in the art based on the examples of the present disclosure without creative efforts shall fall within the protection scope of the present disclosure.

[0038] Example 1

[0039] A compound anti-tumor traditional Chinese medicine composition included the following components in parts by weight: 400 parts of Radix Astragali, 100 parts of red ginseng, 6 parts of large blister beetle, and 3 parts of Venenum Bufonis.

[0040] A preparation method of the compound anti-tumor traditional Chinese medicine composition included the following steps:

[0041] (1) the red ginseng was dried at 60°C for 6 h, placed at room temperature and then crushed into a fine powder, and then passed through a 100 mesh sieve to obtain a red ginseng powder;

[0042] (2) the Radix Astragali was dried at 60°C for 6 h, placed at room temperature and then crushed into a fine powder, and then passed through a 100 mesh sieve to obtain a Radix Astragali powder;

[0043] (3) the Venenum Bufonis was crushed into a fine powder, and then passed through a 100 mesh sieve to obtain a Venenum Bufonis powder; and

[0044] (4) the large blister beetle was crushed into a coarse powder, passed through a 20 mesh sieve, weighed, water was added at 40 times a weight of the large blister beetle powder, and a resulting mixture was subjected to heating reflux extraction 2 times, each time for 2 h; obtained reflux solutions were combined, filtered through a 100 mesh sieve, and a resulting filtrate was concentrated to 1 / 2 of a total volume to obtain a large blister beetle concentrate; the red ginseng powder, a Radix Astragali powder, and a Venenum Bufonis powder were mixed well with the large blister beetle powder, dried at 60°C, crushed, and then sieved by a 20 mesh sieve to obtain the compound anti-tumor traditional Chinese medicine composition.

[0045] A compound anti-tumor traditional Chinese medicine capsule was prepared by loading the compound anti-tumor traditional Chinese medicine composition prepared by the preparation method into a capsule, where the capsule had a specification of 0.4 g per capsule, with 10 capsules per plate.

[0046] Example 2

[0047] A compound anti-tumor traditional Chinese medicine composition included the following components in parts by weight: 300 parts of Radix Astragali, 80 parts of red ginseng, 4 parts of large blister beetle, and 1 part of Venenum Bufonis.

[0048] A preparation method of the compound anti-tumor traditional Chinese medicine composition included the following steps:

[0049] (1) the red ginseng was dried at 65°C for 5 h, placed at room temperature and then crushed into a fine powder, and then passed through a 120 mesh sieve to obtain a red ginseng powder;

[0050] (2) the Radix Astragali was dried at 65°C for 5 h, placed at room temperature and then crushed into a fine powder, and then passed through a 120 mesh sieve to obtain a Radix Astragali powder;

[0051] (3) the Venenum Bufonis was crushed into a fine powder, and then passed through a 120 mesh sieve to obtain a Venenum Bufonis powder; and

[0052] (4) the large blister beetle was crushed into a coarse powder, passed through a 25 mesh sieve, weighed, water was added at 45 times a weight of the large blister beetle powder, and a resulting mixture was subjected to heating reflux extraction 3 times, each time for 2.5 h; obtained reflux solutions were combined, filtered through a 100 mesh sieve, and a resulting filtrate was concentrated to 3 / 4 of a total volume to obtain a large blister beetle concentrate; the red ginseng powder, a Radix Astragali powder, and a Venenum Bufonis powder were mixed well with the large blister beetle powder, dried at 65°C, crushed, and then sieved by a 25 mesh sieve to obtain the compound anti-tumor traditional Chinese medicine composition.

[0053] A compound anti-tumor traditional Chinese medicine capsule was prepared by loading the compound anti-tumor traditional Chinese medicine composition prepared by the preparation method into a capsule, where the capsule had a specification of 0.4 g per capsule, with 10 capsules per plate.

[0054] Example 3

[0055] A compound anti-tumor traditional Chinese medicine composition included the following components in parts by weight: 600 parts of Radix Astragali, 120 parts of red ginseng, 10 parts of large blister beetle, and 4 parts of Venenum Bufonis.

[0056] A preparation method of the compound anti-tumor traditional Chinese medicine composition included the following steps:

[0057] (1) the red ginseng was dried at 55°C for 7 h, placed at room temperature and then crushed into a fine powder, and then passed through an 80 mesh sieve to obtain a red ginseng powder;

[0058] (2) the Radix Astragali was dried at 55°C for 7 h, placed at room temperature and then crushed into a fine powder, and then passed through an 80 mesh sieve to obtain a Radix Astragali powder;

[0059] (3) the Venenum Bufonis was crushed into a fine powder, and then passed through an 80 mesh sieve to obtain a Venenum Bufonis powder; and

[0060] (4) the large blister beetle was crushed into a coarse powder, passed through a 15 mesh sieve, weighed, water was added at 35 times a weight of the large blister beetle powder, and a resulting mixture was subjected to heating reflux extraction 1 time, each time for 2.5 h; obtained reflux solutions were combined, filtered through a 100 mesh sieve, and a resulting filtrate was concentrated to 1 / 4 of a total volume to obtain a large blister beetle concentrate; the red ginseng powder, a Radix Astragali powder, and a Venenum Bufonis powder were mixed well with the large blister beetle powder, dried at 55°C, crushed, and then sieved by a 15 mesh sieve to obtain the compound anti-tumor traditional Chinese medicine composition.

[0061] A compound anti-tumor traditional Chinese medicine capsule was prepared by loading the compound anti-tumor traditional Chinese medicine composition prepared by the preparation method into a capsule, where the capsule had a specification of 0.4 g per capsule, with 10 capsules per plate.

[0062] Example 4 Clinical application of the compound anti-tumor traditional Chinese medicine capsule

[0063] The compound anti-tumor traditional Chinese medicine capsule prepared in Example 1 was applied to tumor patients, all of whom had poor treatment efficiency with targeted drugs, surgery, and chemotherapy or had given up treatment. An effect of the capsule on cancer patients was determined based on tumor size, tumor marker value, chest tightness, headache and other adverse reactions. Currently, there were 12 patients included in this clinical application statistics, and the patients and their tumor types were shown in Table 1. The above statistics were partial statistics of clinical trials on the compound anti-tumor traditional Chinese medicine capsules in the present disclosure, and the relevant clinical trials were still in progress and statistics were being collected.

[0064] Table 1 Tumor patient information

[0065] Patient Tumor type Case 1 Upper lobe adenocarcinoma with multiple metastases (bilateral lungs, mediastinum, right pleural effusion) Case 2 Left upper lobe adenocarcinoma with bone metastasis Case 3 Lung adenocarcinoma with multiple metastases Case 4 Invasive adenocarcinoma of the breast and postoperative recurrence with multiple metastases Case 5 Right lung squamous cell carcinoma Case 6 Adenocarcinoma of lung Case? Diffuse large B-cell lymphoma with widespread metastasis Case 8 Diffuse large B-cell lymphoma with widespread metastasis Case 9 Ovarian cancer with multiple pelvic and bilateral anterior iliac lymph node metastases + peritoneal, mesenteric and pelvic floor metastases Case 10 Poorly differentiated adenocarcinoma of intrahepatic bile duct Case 11 Multiple metastases of primary liver cancer with portal vein tumor thrombus, portal hypertension (splenomegaly, gastric artery varices, esophageal varices, and large amounts of ascites), anemia, hypoproteinemia Case 12 Lung metastasis and local metastasis after diversion and ostomy of bladder cancer surgery

[0066] After understanding the patient's condition, the compound anti-tumor traditional Chinese medicine capsule prepared in Example 1 of the present disclosure was administered at: two capsules at one time, three times one day; taking after meals, a course of treatment of 45 d or as directed by a doctor. Follow-up: the patient's conditions were tracked, the patient's physical conditions were learned, and the patient was allowed to go hospital for regular examinations of relevant tumor indicators. The final efficacy statistical results were shown in Tables 2 to 5. The changes in tumor volume and tumor markers for some patients were shown in FIG. 2 to FIG. 4.

[0067] Determination criteria were: significant: after taking the medicine, the primary tumor / metastatic lesions were reduced, the blood flow inside the tumor was reduced or partially calcified, the various indicators of tumor markers were reduced, and the patient's physical conditions were improved.

[0068] Effective: after taking the medicine, the tumor showed no tendency to shrink, but the cancer cells no longer spread, and common cancer symptoms disappeared, that is, "living with tumor".

[0069] Invalid: the conditions did not improve significantly after taking the medicine and continued to worsen.

[0070] Table 2 Efficacy results

[0071] Group Significant Effective Invalid Effective rate Treatment group 9 3 0 100%

[0072] Table 3 Changes in tumor volume

[0073] ^^^^Changes in tumor ^^^^volume Patient Reduced No significant change Increased Case 1 Tumor shrank by 34% after 57 d of medication - - Case 2 Tumor shrank by 60% after 54 d of medication - - Case 3 Tumor shrank by 37% after 36 d of medication - - Case 4 Right tumor shrunk by 40% and left tumor shrunk by 26% after 32 d of medication - - Case 5 - No volume change - Case 6 - No volume change Case 7 Right groin tumor shrank by 60% after 81 d of medication - - Case 8 - No volume change - Case 9 - No volume change - Case 10 Tumor shrank by 79% after 90 d of medication - - Case 11 - No volume change - Case 12 - No volume change -

[0074] Table 4 Tumor metastasis

[0075] Tumor rn^tastasis Patient Reduced / di sappeared Decreased blood flow distribution (distributed in a star shape) Fibrosis / calcifi cation Case 1 Multiple small metastases disappeared after 45 d of medication Primary lesion shrunk and internal blood flow decreased after 45 d of medication Calcifications increased after 45 d of medication; calcifications in both lungs further increased after 90 d of medication Case 2 CT scans revealing bone metastases disappeared after 9 d of medication; lung metastases disappeared after 21 d of medication Blood flow in tumor decreased after 90 d of medication CT report after 46 d of medication: multiple calcifications in cancer and multiple calcifications in lungs Case 3 Pancreatic metastases disappeared and most of adrenal metastases disappeared after 27 d of medication Blood flow of liver metastasis decreased after 27 d of medication - Case 4 Multiple breast metastases disappeared after one week of medication; lung metastases decreased after 131 d of medication Only one nodule remained with scattered (star-shaped) blood flow after 90 d of medication Calcifications increased after 131 d of medication Case 5 - Blood flow in tumor decreased after 64 d of medication Calcifications increased after 64 d of medication Case 6 - - - Case 7 Multiple metastatic lymphomas on left and right sides of neck disappeared after 38 d of medication - - Case 8 Multiple metastatic lymphomas disappeared after 14 d of medication - - Case 9 - - - Case 10 Review report after second course of treatment: peritoneal metastasis disappeared - - Case 11 - - - Case 12 All lung metastases reported by CT disappeared after 53 d of medication - -

[0076] Table 5 Changes in tumor marker

[0077] Tumor ^^marker Patient Reduced No significant change Increased Case 1 All markers decreased after 57 d of medication - - Case 2 Partial markers decreased after 54 d of medication - - Case 3 Partial markers decreased after 36 d of medication - - Case 4 All markers decreased after 90 d of medication - Case 5 - No change - Case 6 - No change - Case 7 - No change - Case 8 - No change - Case 9 - No change - Case 10 All tumor markers turned negative at the end of second course of treatment - - Case 11 - No change - Case 12 - No change -

[0078] Example 5 Typical cases

[0079] Lu, female, 66 years old, suffered from lung adenocarcinoma. The patient was discovered at the West China Hospital of Sichuan University in 2019 and underwent a puncture biopsy. The pathology report showed lung adenocarcinoma. She gave up radiotherapy and chemotherapy, and successfully used targeted therapy through target matching. Two years later, due to the failure of targeted therapy and massive pulmonary hemorrhage during the first puncture biopsy, the patient was afraid to undergo a puncture biopsy for gene matching, even if she took targeted drugs blindly. Subsequently, the patient experienced a gradual enlargement of the tumor, liver and kidney function damage, a decrease in white blood cells, 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 traditional Chinese medicine capsule (Banchan Capsule) prepared in Example 1, two capsules each time, three times one day, after meals. On August 27, 2023, the patient coughed up three pieces of milky yellow tissue when she woke up in the morning (two pieces were the size of corn kernels, and one piece was the size of one and a half com kernels). The patient suddenly felt that her breathing was unobstructed, and the original feeling of chest tightness and shortness of breath disappeared immediately. After one course of treatment (45 d), the primary lesions were reduced and various indicators of tumor markers were reduced. There were scattered high-density shadows inside the primary lesion -reduced internal blood flow and partial calcifications; there was no enlargement of the hilar and mediastinal lymph nodes - metastasis; the translucency of both lungs increased - lung function was enhanced (more healthy lung tissues).

[0080] Ran, female, 52 years old, suffered from primary lung adenocarcinoma with bone metastasis. As a medical worker, she knew that lung adenocarcinoma was not sensitive to radiotherapy and chemotherapy, so she prepared to do genetic testing in preparation for targeted therapy. During this period, she heard fellow patients talk about Banchan Capsule. When being presented, she had difficulty breathing, progressive weight loss, and fatigue. On September 10, 2023, the patient orally took the compound anti-turnor traditional Chinese medicine capsule (Banchan Capsule) prepared in Example 1, two capsules each time, three times one day, after meals. On the 9th day of medication, the CT report showed that the bone metastases had disappeared. On September 22, 2023, another CT scan showed that the metastatic lesions had disappeared and the primary lesions in the lungs had shrunk. The patient felt that her breathing was smoother, her physical strength was 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, and the patient reported no discomfort and was able to ride a bicycle for more than 10 km at a time and commute to get off work normally. On January 20, 2024, the second course of treatment ended, and its examination report compared with the first course of treatment was: the tumor was shrunk, and there were extensive calcification (scar tissue formed after tumor necrosis and absorption) and reduced blood flow in the tumor.

[0081] Qiu, male, 40 years old, suffered from multiple metastases of lung adenocarcinoma (liver, kidney, pancreas, bone, and intracranial tissue), and portal vein cancer thrombus. The patient was diagnosed two years ago and underwent targeted therapy through gene matching in the first phase, but it was invalid, so he took targeted drugs blindly. Later, the targeted drugs became invalid, and side effects became increasing. The primary lesions grew larger, the number of metastatic lesions increased, the pain worsened, and he could not bear it. On October 6, 2023, the patient took the compound anti-tumor traditional Chinese medicine capsule (Banchan Capsule) prepared in Example 1 after being introduced by a fellow patient, two capsules each time, three times one day, after meals. On October 26, 2023, the patient reported that his abdominal pain had disappeared (liver and pancreatic metastasis) and the pain in the lower back (multiple adrenal gland metastases) had been relieved. On November 2, 2023, the CT report showed a decrease in blood flow to the liver metastases, the disappearance of pancreatic metastases, and the vast majority of disappearance in adrenal metastases. Tumor marker indicators increased by dozens of times (with large areas of tumors rapidly undergoing apoptosis and a large amount of tumor markers entering the blood). The pain in his abdomen and waist disappeared completely.

[0082] Chen, female, 41 years old, suffered from vascular invasive breast cancer with extensive metastasis after surgery. The patient underwent breast cancer surgery two years ago and did not receive chemotherapy after the surgery. In July 2023, recurrence was found on the surgical side, and extensive metastasis occurred in the contralateral breast, bilateral axillae, and lungs. She developed pain and swelling in both breasts and axillae, persistent cough and coughing up large amounts of white foamy sputum (extensive metastasis in the lungs), anemia, and edema. On July 10, 2023, the patient orally took the compound anti-turn or traditional Chinese medicine capsule (Banchan Capsule) prepared in Example 1, two capsules each time, three times one day, after meals. One week later, the patient felt the pain was relieved, the severe cough caused by lung metastases and the large amount of white foamy sputum were significantly reduced, and the patient slept well and had a high-quality diet. On August 19, 2023, Doppler color ultrasound showed that all the metastatic lymph nodes under the axillary on both sides had 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 her breathing was smooth, her sleep was desirable, her appetite was high, and she did not have any pain or other discomfort. Her liver, kidney functions and blood routines were all normal. On January 17, 2024, the patient's tumor continued to shrink, the calcifications increased, and the lung metastases decreased. No other discomfort symptoms were found during this period.

[0083] Chen, female, 73 years old, suffers from diffuse large B-cell lymphoma with extensive metastasis. On August 8, 2023, the pathology report from the Nuclear Industry 416 Hospital of the Second Affiliated Hospital of Chengdu Medical College indicated a puncture biopsy of "abdominal mass" and diffuse large B-cell lymphoma. The patient voluntarily gave up treatment because her body could not tolerate it. On November 1, 2023, the patient orally took the compound anti-tumor traditional Chinese medicine capsule (Banchan Capsule) prepared in Example 1, two capsules each time, three times one day, after meals. On December 8, 2023, the patient's pigeon egg-sized lymphomas on the left and right sides of the neck, the lymphoma under the ribs, and the pigeon egg-sized lymphoma in the left groin had completely disappeared, her abdominal pain symptoms had completely disappeared, the weight had increased, her gray complexion had turned rosy, and her palpitations and fatigue 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, and she had gained weight, and was eating well and sleeping well.

[0084] Zhao, male, 66 years old, suffered from poorly differentiated adenocarcinoma of the intrahepatic bile duct. In mid-July 2023, the patient underwent partial liver resection + microwave ablation of liver tumor at the Fourth Medical Center of the PLA General Hospital in Beijing. On August 8, 2023, he received chemotherapy at the Central Hospital Affiliated to Fudan University in Shanghai. However, after only 3 d of medication, he developed severe fatigue, nausea and vomiting, and was bedridden, so he gave up treatment. The CT report showed a 5.5x5.1 cm mass in the liver, which was twice as large as before the surgery. On Thursday, August 24, 2023, the patient orally took the compound anti-tumor traditional Chinese medicine capsule (Banchan Capsule) prepared in Example 1, two capsules each time, three times one 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 well, 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 re-examination report showed that the tumor had shrunk to 2.5x4.2 cm, the peritoneal metastasis had disappeared, and all tumor markers had turned negative.

[0085] The above descriptions are merely preferred implementations of the present disclosure. It should be noted that a person of ordinary skill in the art may further make several improvements and modifications without departing from the principle of the present disclosure, but such improvements and modifications should be deemed as falling within the protection scope of the present disclosure.

Claims

1. A compound anti-tumor traditional Chinese medicine composition, comprising the following components in parts by weight: 300 parts to 600 parts of Radix Astragali, 80 parts to 120 parts of red ginseng, 4 parts to 10 parts of large blister beetle, and 1 part to 4 parts of Venenum Bufonis.

2. A preparation method of the compound anti-tumor traditional Chinese medicine composition according to claim 1, comprising the following steps:crushing the red ginseng, the Radix Astragali, and the Venenum Bufonis to obtain a red ginseng powder, a Radix Astragali powder, and a Venenum Bufonis powder; and mixing the large blister beetle with water to allow heating reflux extraction, conducting filtration and concentration, mixing an obtained concentrate with the red ginseng powder, the Radix Astragali powder, and the Venenum Bufonis powder evenly, and then drying and crushing an obtained mixture.

3. The preparation method according to claim 2, wherein the red ginseng and the Radix Astragali are dried at 55°C to 65°C for 5 h to 7 h and then allowed to cool to a room temperature before the crushing.

4. The preparation method according to claim 2, wherein the red ginseng, the Radix Astragali, and the Venenum Bufonis after the crushing are sieved through a sieve of 80 mesh to 120 mesh.

5. The preparation method according to claim 2, wherein the large blister beetle is crushed into a coarse powder and then sieved through a sieve of 15 mesh to 25 mesh before mixing with the water.

6. The preparation method according to claim 2, wherein the water is added at 35 to 45 times the parts by weight of the large blister beetle.

7. The preparation method according to claim 2, wherein the heating reflux extraction is conducted 1 to 3 times for 1.5 h to 2.5 h each time.

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

9. A compound anti-tumor traditional Chinese medicine capsule prepared by loading a compound anti-tumor traditional Chinese medicine composition prepared by the preparation method according to any one of claims 2 to 8 into a capsule.

10. Use of the compound anti-tumor traditional Chinese medicine composition according to claim 1, or a compound anti-turnor traditional Chinese medicine composition prepared by the preparation method according to any one of claims 2 to 8, or the compound anti-tumor traditional Chinese medicine capsule according to claim 9 in preparation of an anti-cancer product.

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