A traditional Chinese medicine composition with anticancer effect and a preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition which has excellent effect of treating liver cancer. The traditional Chinese medicine composition is composed of gentiana, dandelion, capillary random fiber, Chinese toona, eupolyphaga, monitor lizard, paris polyphylla, inula flower, ocher, tuber fleeceflower root, stone cypress, epimedium, cat's claw. The preparation method of the traditional Chinese medicine composition comprises the following steps: gentiana, dandelion and the like are respectively crushed and mixed, then extracted by using an organic solvent to obtain an organic solvent extract; the extract obtained by drying the organic solvent extract under reduced pressure is crushed, and ocher after crushing is added, so that the traditional Chinese medicine composition is obtained. The raw medicinal materials selected by the application are synergistic and mutually complementary in nature and effect, and jointly play a role in accordance with the overall concept of traditional Chinese medicine and inhibit the growth of cancer cells. The traditional Chinese medicine composition has the advantages of simple preparation process and the like, is suitable for commercial application, and has a wide application prospect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition with anti-cancer effects, its preparation method, and its application. Background Technology

[0002] Liver cancer is a malignant tumor that occurs in or originates in the liver. Cancer can also metastasize to the liver from other sites, a condition known as liver metastases, which occur more frequently than primary liver tumors. Symptoms of liver cancer include a lump or pain below the right side of the ribcage, ascites, jaundice, easy bruising, weight loss, and general weakness.

[0003] Liver cancer is the third most common malignant tumor with the third-highest mortality rate, after stomach and esophageal cancer. Early symptoms are often subtle, while late-stage symptoms include liver pain, fatigue, weight loss, jaundice, and ascites. Currently, there are many anti-cancer treatments available, including surgery, radiotherapy, chemotherapy, interventional therapy, targeted therapy, immunotherapy, and traditional Chinese medicine. However, in most cases, a single treatment method cannot eradicate cancer. Overcoming cancer requires a combination of treatments, leveraging the advantages of multiple approaches, i.e., individualized treatment based on the patient's specific condition.

[0004] Traditional Chinese medicine (TCM) often attributes the cause of tumors to stagnation of qi, blood, phlegm, and dampness; that is, tumors are formed by the binding of pathological products such as qi, blood, phlegm, and dampness. However, conventional treatments for qi stagnation, blood stasis, and phlegm accumulation are often ineffective. This prompts us to further explore the true nature of tumors. In fact, the nature of tumors is fundamentally different from the general qi stagnation, blood stasis, phlegm, and dampness accumulation in internal medicine. While factors of qi stagnation, blood stasis, phlegm, and dampness accumulation are indeed present in tumor patients, their essence lies in a potent toxin formed on the basis of inducing factors such as the six external evils (wind, cold, heat, dampness, dryness, and fire), the seven emotions (emotions, thirst, anger, and thirst), diet, and overwork. Treating this toxin requires the use of potent drugs, i.e., "fighting poison with poison."

[0005] The principles of Traditional Chinese Medicine (TCM) in treating tumors: The human body has the ability to protect itself and heal itself. It also has its own resistance to tumors. When the body's self-protective functions are sufficient to suppress the tumor, it appears normal; when the body's self-protective capabilities are insufficient, tumors develop. TCM treatment for tumors can be applied at all stages. Many patients only choose TCM treatment when Western medicine has exhausted its options and the tumor has reached an advanced stage. However, TCM treatment should actually be integrated into every stage of tumor treatment. In early-stage tumors, after surgery, TCM can help patients regulate their bodies, quickly restore their vital energy, adjust their physical environment, and prevent tumor recurrence. For patients with advanced tumors, after Western medicine has completed a series of treatments, TCM can help with "post-treatment care," alleviating various adverse reactions and reducing the risk of recurrence. When the tumor reaches the terminal stage, the application of TCM can alleviate the patient's suffering, improve their quality of life, and prolong their survival. Summary of the Invention

[0006] In order to overcome at least one of the technical problems existing in the prior art, the present invention first provides a traditional Chinese medicine composition; the traditional Chinese medicine composition has excellent therapeutic effect on liver cancer.

[0007] The technical problem to be solved by the present invention is achieved through the following technical solution:

[0008] A traditional Chinese medicine composition comprising the following raw materials: gentian root, dandelion, artemisia capillaris, Sichuan chinaberry, ground beetle, gecko, Paris polyphylla, Inula japonica, hematite, sclerotium affine, Selaginella tamariscina, Epimedium leaf, and cat's claw herb.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-5 parts gentian root, 3-10 parts dandelion, 0.2-1 parts artemisia capillaris, 0.2-0.5 parts Sichuan pepper, 0.05-0.15 parts ground beetle, 1-3 parts gecko, 0.1-0.5 parts Paris polyphylla, 2-7 parts Inula japonica, 0.01-0.03 parts hematite, 0.3-0.8 parts rhizome, 2-9 parts Selaginella tamariscina, 3-6 parts Epimedium leaf, and 1-8 parts Uncaria rhynchophylla.

[0010] The inventors unexpectedly discovered in their previous research that the traditional Chinese medicine composition prepared from thirteen kinds of Chinese medicinal herbs, including gentian, dandelion, artemisia capillaris, Sichuan chinaberry, ground beetle, gecko, Paris polyphylla, Inula japonica, hematite, sclerotium affine, Selaginella tamariscina, Epimedium leaf, and Uncaria rhynchophylla, has excellent anti-liver cancer effects.

[0011] Preferably, the liver cancer is hepatocellular carcinoma or intrahepatic cholangiocarcinoma.

[0012] Preferably, the liver cancer is hepatocellular carcinoma.

[0013] Preferably, the liver cancer is hepatocellular carcinoma.

[0014] The method for preparing the traditional Chinese medicine composition of the present invention comprises the following steps:

[0015] Gentian root, dandelion, artemisia capillaris, Sichuan chinaberry, ground beetle, gecko, Paris polyphylla, Inula japonica, Sedum aizoon, Epimedium leaf, and cat's claw grass were pulverized and mixed, then extracted with an organic solvent to obtain an organic solvent extract. The extract obtained after vacuum drying of the organic solvent extract was pulverized, and pulverized hematite was added to obtain the aforementioned traditional Chinese medicine composition.

[0016] Preferably, the organic solvent comprises one or more of ethanol, dichloromethane, petroleum ether, diethyl ether, and ethyl acetate.

[0017] Preferably, the organic solvent is selected from one or more of ethanol, dichloromethane, petroleum ether, diethyl ether, and ethyl acetate.

[0018] Preferably, the organic solvent is selected from any two of ethanol, dichloromethane, petroleum ether, diethyl ether, and ethyl acetate.

[0019] Gentian, also known as foxglove, is an autumn-flowering herbaceous plant with significant medicinal value. It contains abundant active ingredients with properties such as clearing heat and detoxifying, antibacterial and insecticidal effects, anti-inflammatory, anti-allergic, antiviral, and anti-cancer properties. The active ingredients in gentian can effectively inhibit the growth and division of tumor cells, reducing the damage caused by tumor cells to the body, thereby achieving an anti-cancer effect.

[0020] Dandelion contains the active ingredient T-1, which has an inhibitory effect on cancer cells corresponding to breast cancer, liver cancer, pancreatic cancer, gastric cancer, and ovarian cancer. Moreover, dandelion polysaccharides can significantly increase the spleen index and thymus index in mice, promote the growth and development of immune organs in mice, and help improve the immunity of mice, thereby achieving anti-tumor effects.

[0021] The coumarins, terpenes, flavonoids, coumaric acid, chlorogenic acid, and other components contained in Artemisia capillaris may have anti-cancer activity; Artemisia capillaris can exert anti-tumor effects by directly killing tumors, among which the effective component is chromogenone; citronella has a good protective effect against radiation and nitrogen mustard damage, and also shows a good detoxification effect against the carcinogen cyclophosphamide; Artemisia capillaris diacetylone and Artemisia capillaris dienone extracted from the methanol extract of Artemisia capillaris can both inhibit the activity of carcinogens.

[0022] The azadirachtin contained in *Melia toosendan* fruit exhibits inhibitory activity against various tumor cells, including ovarian cancer, Ewing's sarcoma, gastric cancer, colorectal cancer, and pancreatic cancer. Its mechanisms of action primarily include inhibiting cell proliferation, inducing apoptosis, arresting the cell cycle, inhibiting epithelial-mesenchymal transition in tumor cells, and regulating signal transduction and transcriptional activating factors and signaling pathways such as factor 3, p53, microRNA, Notch, and Wnt / β-linkin. Furthermore, azadirachtin can effectively reverse resistance to the antitumor drugs doxorubicin and regorafenib. When used in combination with cisplatin and doxorubicin, azadirachtin can enhance the sensitivity of tumor cells to these antitumor drugs, thereby strengthening the anticancer therapeutic effect and demonstrating its potential as an antitumor drug.

[0023] Modern Traditional Chinese Medicine (TCM) widely utilizes *Eupolyphaga sinensis* (a type of ground beetle) in the treatment of various tumors, such as breast cancer, stomach cancer, liver cancer, bone tumors, metastatic bone tumors, cervical cancer, multiple myeloma, leukemia, and lung cancer, achieving good therapeutic effects. Experimental studies have also shown that *Eupolyphaga sinensis* has a certain inhibitory effect on tumors in experimental animals, and can inhibit the in vitro proliferation of liver cancer, stomach cancer, esophageal cancer, lung cancer, sarcoma, breast cancer, and cervical cancer cells.

[0024] Gecko is also known as house lizard. In ancient times, traditional Chinese medicine practitioners discovered that geckos could be used as medicine, with the effects of dispelling wind, calming convulsions, relieving pain, and dissipating nodules. Modern pharmacological research has proven that geckos have anti-tumor effects. Medical staff found through in vitro experiments that its extracts can inhibit human liver cancer cells. Japanese scholars conducted preliminary screening research on its anti-cancer activity and confirmed that the inhibition rate of geckos on cancer cell growth is over 75%.

[0025] Paris polyphylla Smith is also known as Paris vietnamensis (Takht.) H. Li, Paris vietnamensis (Takht.) H. Li var. wangiana (Sun) H. Li, Trillium tschonoskii Maxim., etc. It is bitter, slightly cold, and slightly poisonous. It belongs to the liver meridian. It has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, cooling the liver and calming convulsions, and anti-cancer. Paris polyphylla Smith is one of the commonly used anti-cancer traditional Chinese medicines in clinical practice and can be used to treat thyroid cancer, nasopharyngeal cancer, lung cancer, cervical cancer, esophageal cancer, gastric cancer, intestinal cancer, brain tumors, malignant lymphoma, etc., and can also be used to treat cancerous fever and cancerous pain.

[0026] Inula japonica Thunb. can be used to treat various cancers such as esophageal cancer, gastric cancer, mediastinal tumors, colon cancer, gingival cancer, breast cancer, and brain tumors. In the folk of Yunnan, there is a folk tradition of using Inula japonica Thunb. to treat cancer. Modern pharmacological research has proven that the sesquiterpene lactones and flavonoid compounds contained in the flowers and leaves of Inula japonica Thunb. are its anti-cancer active ingredients. Inula japonica Thunb. is often combined with hematite as a medicinal pair.

[0027] Sarcandra glabra (Thunb.) Nakai can not only directly induce apoptosis of tumor cells, inhibit the proliferation of tumor cells, but also have a significant synergistic effect on radiotherapy and chemotherapy. Therefore, Sarcandra glabra (Thunb.) Nakai is currently widely used in the treatment of digestive tract tumors such as gastric cancer, esophageal cancer, pancreatic cancer, intestinal cancer, liver cancer, and gallbladder cancer, as well as various solid tumors such as lung cancer, breast cancer, bladder cancer, and prostate cancer. When treating cancer, Sarcandra glabra (Thunb.) Nakai tablets or Sarcandra glabra (Thunb.) Nakai injection can be used alone, or it can be used in combination with other drugs according to the methods of traditional Chinese medicine.

[0028] Selaginella doederleinii Hieron. is a common medicine in the prescriptions of traditional Chinese oncology and is often used to treat various cancers such as lung cancer, liver cancer, nasopharyngeal cancer, laryngeal cancer, cervical cancer, ovarian cancer, malignant hydatidiform mole, choriocarcinoma, and liposarcoma.

[0029] The extract of Epimedium leaves, after concentration treatment, has been shown by experiments to have inhibitory effects on both sarcoma and the metastasis of Lewis lung cancer, and can also prevent chemical carcinogenesis and Escherichia coli infection. At the same time, a brown compound with weak acidity that inhibits has been extracted from Epimedium brevicornu Maxim., which can enhance the immune function of normal cells against cancer cells.

[0030] Ranunculus ternatus Thunb. can treat various solid cancers, lymphomas, etc., with remarkable curative effects and high cure rates. It is a good traditional Chinese medicine for anti-tumor, detoxifying, and dissipating nodules. Modern experiments have shown that Ranunculus ternatus Thunb. has good inhibitory effects on mouse sarcoma S180, sarcoma S37, and Ehrlich ascites carcinoma in animal experiments.

[0031] The advantages of the present invention are as follows:

[0032] Traditional Chinese medicine (TCM) prescriptions emphasize the compatibility and synergistic effects between various medicinal components. This synergy enhances efficacy, expands the therapeutic range, and reduces adverse reactions. The combination of TCM components is not simply an additive effect of individual parts. The raw medicinal materials selected in this invention exhibit both synergistic and complementary properties, adhering to the holistic concept of TCM, working together to inhibit cancer cell growth.

[0033] The traditional Chinese medicine composition of the present invention also has the advantages of simple preparation process, making it suitable for commercial application and with broad application prospects. Detailed Implementation

[0034] The present invention will be further described below with reference to specific embodiments, and the advantages and features of the present invention will become clearer as a result. However, these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. Those skilled in the art should understand that modifications or substitutions can be made to the details and form of the technical solutions of the present invention without departing from the spirit and scope of the present invention, but all such modifications and substitutions fall within the protection scope of the present invention.

[0035] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0036] Take 1 part gentian root, 3 parts dandelion, 0.2 parts artemisia capillaris, 0.2 parts Sichuan chinaberry, 0.05 parts ground beetle, 1 part gecko, 0.1 part Paris polyphylla, 2 parts Inula japonica, 0.3 parts Euphorbia milii, 2 parts Selaginella tamariscina, 3 parts Epimedium leaf, and 1 part Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.02 parts crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0037] The ratio of the total weight of Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Sedum aizoon, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1 g: 10 mL.

[0038] The organic solvent is composed of ethanol and ethyl acetate in a volume ratio of 2:1.

[0039] Example 2: Preparation of the Traditional Chinese Medicine Composition

[0040] Take 2 parts of gentian root, 5 parts of dandelion, 0.5 parts of artemisia capillaris, 0.5 parts of Sichuan pepper, 0.1 parts of ground beetle, 2 parts of gecko, 0.3 parts of Paris polyphylla, 2 parts of Inula japonica, 0.5 parts of Euphorbia milii, 4 parts of Selaginella tamariscina, 4 parts of Epimedium brevicornu, and 3 parts of Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.01 parts of crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0041] The ratio of the total weight of Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Sedum aizoon, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1 g: 15 mL.

[0042] The organic solvent is composed of diethyl ether and ethyl acetate in a volume ratio of 1:3.

[0043] Example 3: Preparation of the Traditional Chinese Medicine Composition

[0044] Take 5 parts of gentian root, 9 parts of dandelion, 0.8 parts of artemisia capillaris, 0.5 parts of Sichuan pepper, 0.15 parts of ground beetle, 3 parts of gecko, 0.3 parts of Paris polyphylla, 5 parts of Inula japonica, 0.8 parts of Euphorbia milii, 8 parts of Selaginella tamariscina, 6 parts of Epimedium brevicornu, and 6 parts of Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.01 parts of crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0045] The ratio of the total weight of Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Sedum aizoon, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1g:20mL.

[0046] The organic solvent is composed of diethyl ether and petroleum ether in a volume ratio of 2:3.

[0047] Example 4: Preparation of the Traditional Chinese Medicine Composition

[0048] Take 4 parts of gentian root, 10 parts of dandelion, 1 part of artemisia capillaris, 0.5 parts of Sichuan pepper, 0.15 parts of ground beetle, 3 parts of gecko, 0.5 parts of Paris polyphylla, 7 parts of Inula japonica, 0.8 parts of Euphorbia milii, 5 parts of Selaginella tamariscina, 5 parts of Epimedium brevicornu, and 8 parts of Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.03 parts of crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0049] The ratio of the total weight of Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Rhizoma Sedum, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent was 1.5 g: 20 mL.

[0050] The organic solvent is composed of dichloromethane and petroleum ether in a volume ratio of 2:5.

[0051] Preparation of Traditional Chinese Medicine Composition in Comparative Example 1

[0052] Take 1 part gentian root, 3 parts dandelion, 0.2 parts artemisia capillaris, 0.2 parts Sichuan chinaberry, 0.05 parts ground beetle, 1 part gecko, 0.1 part Paris polyphylla, 2 parts Inula japonica, 0.3 parts Euphorbia milii, 2 parts Selaginella tamariscina, 3 parts Epimedium leaf, and 1 part Uncaria rhynchophylla. Grind them into powder and mix them. Place the mixture in a solvent and extract it at 25°C for 2 days to obtain a solvent extract. After drying the extract, grind the resulting extract and add 0.02 parts of ground hematite to obtain the traditional Chinese medicine composition.

[0053] The difference between Comparative Example 1 and Example 1 lies in the solvent used for extracting the traditional Chinese medicine; Comparative Example 1 uses water, while Example 1 uses an organic solvent consisting of ethanol and ethyl acetate in a volume ratio of 2:1. All other operations are the same as in Example 1.

[0054] Preparation of Traditional Chinese Medicine Composition in Comparative Example 2

[0055] Take 1 part gentian root, 3 parts dandelion, 0.2 parts artemisia capillaris, 0.2 parts Sichuan chinaberry, 0.05 parts ground beetle, 1 part gecko, 0.1 part Paris polyphylla, 2 parts Inula japonica, 0.3 parts Euphorbia milii, 2 parts Selaginella tamariscina, 3 parts Epimedium leaf, and 1 part Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, pulverize the resulting extract to obtain the aforementioned traditional Chinese medicine composition.

[0056] The ratio of the total weight of Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Sedum aizoon, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1 g: 10 mL.

[0057] The organic solvent is composed of ethanol and ethyl acetate in a volume ratio of 2:1.

[0058] The difference between Comparative Example 2 and Example 1 is that Comparative Example 2 did not include hematite, while Example 1 included 0.02 parts of pulverized hematite. The remaining operations were the same as in Example 1.

[0059] Preparation of the traditional Chinese medicine composition in Comparative Example 3

[0060] Take 1 part of Houttuynia cordata, 3 parts of Taraxacum mongolicum, 0.2 parts of Artemisia capillaris, 0.2 parts of Melia toosendan, 0.05 parts of Eupolyphaga sinensis, 1 part of Gecko, 0.1 parts of Paris polyphylla, 2 parts of Inula japonica, 0.3 parts of Rhizoma Sedum, 2 parts of Selaginella tamariscina, 3 parts of Epimedium brevicornu, and 1 part of Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.02 parts of crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0061] The ratio of the total weight of Houttuynia cordata, dandelion, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, gecko, Paris polyphylla, Inula japonica, Sedum aizoon, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1g:10mL.

[0062] The organic solvent is composed of ethanol and ethyl acetate in a volume ratio of 2:1.

[0063] The difference between Comparative Example 3 and Example 1 is that Comparative Example 3 uses Houttuynia cordata instead of Gentiana scabra. The rest of the operation is the same as in Example 1.

[0064] Preparation of the traditional Chinese medicine composition in Comparative Example 4

[0065] Take 1 part of Houttuynia cordata, 3 parts of Taraxacum mongolicum, 0.2 parts of Artemisia capillaris, 0.2 parts of Melia toosendan, 0.05 parts of Eupolyphaga sinensis, 1 part of Gecko, 0.1 parts of Paris polyphylla, 2 parts of Inula japonica, 0.3 parts of Rhizoma Scrophulariae, 2 parts of Curcumae zedoaria, 3 parts of Epimedium brevicornu, and 1 part of Uncaria rhynchophylla. Crush and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.02 parts of crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0066] The ratio of the total weight of Houttuynia cordata, dandelion, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, gecko, Paris polyphylla, Inula japonica, Rhizoma Scutellariae, Curcumae zedoaria, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1g:10mL.

[0067] The organic solvent is composed of ethanol and ethyl acetate in a volume ratio of 2:1.

[0068] The difference between Comparative Example 4 and Example 1 is that Comparative Example 4 uses Curcuma zedoaria instead of Selaginella tamariscina. The rest of the operation is the same as in Example 1.

[0069] Preparation of the traditional Chinese medicine composition in Comparative Example 5

[0070] Take 1 part of Houttuynia cordata, 3 parts of Taraxacum mongolicum, 0.2 parts of Artemisia capillaris, 0.2 parts of Melia toosendan, 0.05 parts of Eupolyphaga sinensis, 1 part of Gecko, 0.1 parts of Hedyotis diffusa, 2 parts of Inula japonica, 0.3 parts of Rhizoma Scrophulariae, 2 parts of Curcumae zedoaria, 3 parts of Epimedium brevicornu, and 1 part of Uncaria rhynchophylla. Crush them and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.02 parts of crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0071] The ratio of the total weight of Houttuynia cordata, dandelion, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, gecko, Hedyotis diffusa, Inula japonica, Sedum aizoon, Epimedium brevicornu, and Uncaria rhynchophylla to the volume of the organic solvent is 1g:10mL.

[0072] The organic solvent is composed of ethanol and ethyl acetate in a volume ratio of 2:1.

[0073] The difference between Comparative Example 5 and Example 1 is that Comparative Example 5 uses Hedyotis diffusa instead of Paris polyphylla. The rest of the operations are the same as in Example 1.

[0074] Preparation of Traditional Chinese Medicine Composition in Comparative Example 6

[0075] Take 1 part gentian root, 3 parts dandelion, 0.2 parts artemisia capillaris, 0.2 parts Sichuan chinaberry, 0.05 parts ground beetle, 1 part gecko, 0.1 part Paris polyphylla, 2 parts Selaginella tamariscina, and 3 parts Epimedium leaves. Crush them and mix them. Place the mixture in an organic solvent and extract it at 25°C for 2 days to obtain an organic solvent extract. After drying the organic solvent extract under reduced pressure, crush the resulting extract and add 0.02 parts crushed hematite to obtain the aforementioned traditional Chinese medicine composition.

[0076] The ratio of the total weight of Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Selaginella tamariscina, Epimedium brevicornu, and the volume of the organic solvent is 1g:10mL.

[0077] The organic solvent is composed of ethanol and ethyl acetate in a volume ratio of 2:1.

[0078] The difference between Comparative Example 6 and Example 1 is that Comparative Example 6 did not include Inula japonica, Rhizoma Scutellariae, and Herba Uncariae, while Example 1 included 2 parts Inula japonica, 0.3 parts Rhizoma Scutellariae, and 1 part Herba Uncariae. The remaining operations were the same as in Example 1.

[0079] Experiment Example 1: An experiment to inhibit the activity of liver cancer cells in vitro.

[0080] Cancer cells: HepG2 cells, a type of hepatocellular carcinoma.

[0081] Test drugs: Traditional Chinese medicine compositions prepared in Examples 1-4 and Comparative Examples 1-6.

[0082] Test method: Incubate in RPMI 1640 medium in 96-well plates, then add 3×10⁻⁶ ppm of the medium to each well. 4HepG2 cancer cells were placed in an incubator and cultured at 37°C with 5% CO2 for 36 hours. After culture, the culture medium was changed. The experimental groups were added with RPMI 1640 medium containing 0.01-200 μg / mL of the traditional Chinese medicine compositions of Examples 1-4 and Comparative Examples 1-6, respectively; the blank group was added with blank RPMI 1640 medium. After culturing for another 36 hours, MTT at a concentration of 5 mg / mL was added, and culture was continued for another 4 hours. After culture, the supernatant was aspirated, and then 100 μL of DMSO was added. The cells were placed in the dark for 15 minutes, and then the absorbance was measured at 570 nm using a microplate reader. Each treatment was repeated in 3 wells. Cell viability was calculated based on the absorbance, and the half-inhibitory concentration (IC50) was calculated based on the dose-response curve. Cell viability (%) = ΔOD drug treatment group / ΔOD blank group × 100%; the experimental results are shown in Table 1.

[0083] Table 1. Experimental results of the anti-hepatocellular carcinoma cell activity of the traditional Chinese medicine composition of the present invention.

[0084] Group IC50 value (ug / mL) The traditional Chinese medicine composition prepared in Example 1 1.0 The traditional Chinese medicine composition prepared in Example 2 5.6 The traditional Chinese medicine composition prepared in Example 3 3.6 The traditional Chinese medicine composition prepared in Example 4 8.4 The traditional Chinese medicine composition prepared in Comparative Example 1 22.3 The traditional Chinese medicine composition prepared in Comparative Example 2 36.7 The traditional Chinese medicine composition prepared in Comparative Example 3 73.5 The traditional Chinese medicine composition prepared in Comparative Example 4 44.6 The traditional Chinese medicine composition prepared in Comparative Example 5 38.6 The traditional Chinese medicine composition prepared in Comparative Example 6 60.7

[0085] As can be seen from the experimental data in Table 1, the traditional Chinese medicine compositions prepared in Examples 1-4 have an IC50 value against liver cancer cells. 50 The concentration was below 10 μg / mL, demonstrating excellent anti-cancer effects. This indicates that the herbal composition obtained by using thirteen kinds of traditional Chinese medicine as raw materials—gentian root, dandelion, artemisia capillaris, Sichuan pepper, ground beetle, gecko, Paris polyphylla, Inula japonica, hematite, Sedum aizoon, Selaginella tamariscina, Epimedium leaf, and Uncaria rhynchophylla—and extracted with one or more organic solvents composed of ethanol, dichloromethane, petroleum ether, diethyl ether, and ethyl acetate, exhibits excellent anti-cancer activity.

[0086] Although the traditional Chinese medicine compositions prepared in comparative examples 1-6 also showed good anti-cancer effects, IC 50 The values ​​were in the range of 20-80 μg / mL, but compared with Examples 1-4, their IC50 values ​​were lower. 50 The value increased significantly. The above results show that the anticancer effect of the traditional Chinese medicine composition obtained by organic solvent extraction is significantly better than that obtained by water extraction. Removing one or more of the following traditional Chinese medicines—Gentiana scabra, Taraxacum mongolicum, Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Hematite, Rhizoma Sedum, Selaginella tamariscina, Epimedium brevicornu, and Uncaria rhynchophylla—or replacing them with similarly effective herbs, significantly reduced the anticancer effect. It is evident that the effective components in the composition prepared by this invention exhibit a very significant synergistic effect. The selected raw medicinal materials are both synergistic and complementary in their properties and effects, adhering to the holistic concept of traditional Chinese medicine, working together to inhibit cancer cell growth, fully leveraging the advantages of traditional Chinese medicine in antitumor activity, and it is expected to alleviate patient suffering, improve quality of life, and prolong survival in clinical practice.

[0087] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition with anti-cancer effects, characterized in that, The composition comprises the following raw materials in parts by weight: 1-5 parts gentian root, 3-10 parts dandelion, 0.2-1 part artemisia capillaris, 0.2-0.5 parts Sichuan pepper, 0.05-0.15 parts ground beetle, 1-3 parts gecko, 0.1-0.5 parts Paris polyphylla, 2-7 parts Inula japonica, 0.01-0.03 parts hematite, 0.3-0.8 parts Euphorbia milii, 2-9 parts Selaginella tamariscina, 3-6 parts Epimedium leaf, and 1-8 parts Uncaria rhynchophylla; the preparation method of the composition is described below. The process includes the following steps: Artemisia capillaris, Melia toosendan, Eupolyphaga sinensis, Gecko, Paris polyphylla, Inula japonica, Rhizoma Sedum, Selaginella tamariscina, Epimedium brevicornu, and Uncaria rhynchophylla are pulverized and mixed, then extracted with an organic solvent to obtain an organic solvent extract; the organic solvent extract is dried under reduced pressure, and the resulting extract is pulverized, and pulverized hematite is added to obtain the aforementioned traditional Chinese medicine composition; the organic solvent is selected from any two of ethanol, dichloromethane, petroleum ether, diethyl ether, and ethyl acetate.

2. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating liver cancer.

3. The application according to claim 2, wherein the liver cancer is hepatocellular carcinoma.