Traditional Chinese medicine composition for preventing or treating liver cancer and / or resisting liver injury

Abstract

The invention provides a traditional Chinese medicine composition for preventing or treating liver cancer and / or resisting liver injury, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention is prepared from the following raw materials: saussurea involucrate, dandelion, phellinus igniarius, lucid ganoderma, red ginseng, rabdosia rubescens, turmeric, pine needle, radix scrophulariae and coptis chinensis. The traditional Chinese medicine composition provided by the invention has excellent liver cancer cell proliferation inhibiting activity and excellent liver injury resisting activity, and can be used for preparing medicines for preventing or treating liver cancer and / or medicines for resisting liver injury.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for preventing or treating liver cancer and / or resisting liver damage. Background Art

[0002] Liver cancer is a malignant tumor of the liver, which can be divided into two categories: primary and secondary. Primary malignant liver tumors originate from the epithelial or mesenchymal tissue of the liver. The former is called primary liver cancer, which is a highly prevalent and extremely harmful malignant tumor in my country; the latter is called sarcoma, which is relatively rare compared with primary liver cancer. Secondary or metastatic liver cancer refers to malignant tumors originating from multiple organs throughout the body that invade the liver. It is generally common in liver metastases from malignant tumors of organs such as the stomach, bile duct, pancreas, colorectum, ovary, uterus, lung, and breast.

[0003] The etiology and exact molecular mechanism of primary liver cancer are not yet fully understood. It is believed that its onset is a complex process with multiple factors and steps, which is affected by both environmental and dietary factors. Epidemiological and experimental research data show that hepatitis B virus (HBV) and hepatitis C virus (HCV) infection, aflatoxin, drinking water pollution, alcohol, cirrhosis, sex hormones, nitrosamines, trace elements, etc. are all related to the onset of liver cancer. Secondary liver cancer (metastatic liver cancer) can develop through different pathways, such as metastasis through blood and lymph or direct invasion of the liver.

[0004] Treatments for liver cancer include surgery, radiotherapy, chemotherapy, intervention, targeted drugs, immunotherapy, and other methods. Individualized comprehensive treatment according to the different stages of liver cancer is the key to improving efficacy; treatment methods include surgery, hepatic artery ligation, hepatic artery chemoembolization, radiofrequency, freezing, laser, microwave, chemotherapy, and radiotherapy. Biological treatment and traditional Chinese medicine are also widely used in the treatment of liver cancer.

[0005] Traditional Chinese medicine therapy adopts the method of syndrome differentiation and treatment, and is often used in combination with other therapies. It can improve the body's resistance to disease, improve the general condition and symptoms, and reduce the adverse reactions of chemotherapy and radiotherapy. Under the guidance of the clinical medicine system of combining traditional Chinese and Western medicine, a clinical diagnosis and treatment model combining disease and syndrome is adopted, and the use of Chinese medicine prescriptions, modern Chinese medicine preparations, and Chinese medicine characteristic diagnosis and treatment techniques can improve the clinical symptoms of liver cancer patients, improve the body's resistance, reduce the adverse reactions of radiotherapy, chemotherapy, immunotherapy, etc., reduce the postoperative recurrence rate, prolong the postoperative recurrence-free survival period, and improve the quality of life of patients. However, the traditional Chinese medicine therapy of the existing technology still has problems such as slow onset and low efficacy.

[0006] Therefore, there is still an urgent need for an anti-liver cancer drug composition with rapid onset and good efficacy. Summary of the invention

[0007] In order to solve the above technical problems, the present invention provides the following technical solutions.

[0008] In a first aspect, the present invention provides a Chinese medicine composition.

[0009] A Chinese medicine composition comprises the following raw materials: snow lotus, dandelion, mulberry linterus, ganoderma lucidum, red ginseng, rubescens, turmeric, pine needles, Scrophularia ningpoensis and coptis root.

[0010] In some embodiments, the weight parts of each raw material in the traditional Chinese medicine composition are: 3-7 weight parts of Saussurea tianshanica (for example, 3 weight parts, 4 weight parts, 5 weight parts, 6 weight parts or 7 weight parts), 20-30 weight parts of Taraxacum officinale (for example, 20 weight parts, 21 weight parts, 22 weight parts, 23 weight parts, 24 weight parts, 25 weight parts, 26 weight parts, 27 weight parts, 28 weight parts, 29 weight parts or 30 weight parts), 15-25 weight parts of Phellinus linteus (for example, 15 weight parts, 16 weight parts, 17 weight parts, 18 weight parts, 19 weight parts, 20 weight parts, 21 weight parts, 22 weight parts, 23 weight parts, 24 weight parts or 25 weight parts), 15-25 weight parts of Ganoderma lucidum (for example, 15 weight parts, 16 parts by weight, 17 parts by weight, 18 parts by weight, 19 parts by weight, 20 parts by weight, 21 parts by weight, 22 parts by weight, 23 parts by weight, 24 parts by weight or 25 parts by weight), 1-5 parts by weight of red ginseng (e.g., 1 part by weight, 2 parts by weight, 3 parts by weight, 4 parts by weight or 5 parts by weight), 5-15 parts by weight of wintergrass (e.g., 5 parts by weight, 6 parts by weight, 7 parts by weight, 8 parts by weight, 9 parts by weight, 10 parts by weight, 11 parts by weight, 12 parts by weight, 13 parts by weight, 14 parts by weight or 15 parts by weight), 5-15 parts by weight of turmeric (e.g., 5 parts by weight, 6 parts by weight, 7 parts by weight, 8 parts by weight, 9 parts by weight, 10 parts by weight, 11 parts by weight, 12 parts by weight, 13 parts by weight, 14 parts by weight or 15 parts by weight), 1-3 parts by weight (e.g., 1 part by weight, 2 parts by weight, or 3 parts by weight) of pine needles, 1-5 parts by weight (e.g., 1 part by weight, 2 parts by weight, 3 parts by weight, 4 parts by weight, or 5 parts by weight) of Scrophularia ningpoensis, and 2-6 parts by weight (e.g., 2 parts by weight, 3 parts by weight, 4 parts by weight, 5 parts by weight, or 6 parts by weight) of Coptis chinensis.

[0011] In some embodiments, the Chinese medicine composition is composed of the following raw materials in parts by weight: 3 parts by weight of Saussurea involucrata, 20 parts by weight of Taraxacum mongolicum, 15 parts by weight of Phellinus igniarius, 15 parts by weight of Ganoderma lucidum, 1 part by weight of Red ginseng, 5 parts by weight of Rubescens rubescens, 5 parts by weight of Curcuma longa, 1 part by weight of Pine needles, 1 part by weight of Scrophularia ningpoensis and 2 parts by weight of Coptis chinensis.

[0012] In some embodiments, the Chinese medicine composition is composed of the following raw materials in parts by weight: 5 parts by weight of Saussurea involucrata, 25 parts by weight of Taraxacum mongolicum, 19 parts by weight of Phellinus igniarius, 19 parts by weight of Ganoderma lucidum, 3 parts by weight of red ginseng, 10 parts by weight of Rubescens rubescens, 10 parts by weight of Curcuma longa, 2 parts by weight of pine needles, 3 parts by weight of Scrophularia ningpoensis and 4 parts by weight of Coptis chinensis.

[0013] In some embodiments, the Chinese medicine composition is composed of the following raw materials in parts by weight: 7 parts by weight of Saussurea involucrata, 30 parts by weight of Taraxacum mongolicum, 25 parts by weight of Phellinus igniarius, 25 parts by weight of Ganoderma lucidum, 5 parts by weight of Red ginseng, 15 parts by weight of Rubescens rubescens, 15 parts by weight of Curcuma longa, 3 parts by weight of pine needles, 5 parts by weight of Scrophularia ningpoensis and 6 parts by weight of Coptis chinensis.

[0014] In some embodiments, the dosage form of the Chinese medicine composition is tablets, capsules, granules, pills, pastes or powders.

[0015] In some embodiments, the dosage form of the Chinese medicine composition is honey pills.

[0016] Saussurea involucrata: This product is the dried aerial part of Saussurea involucrata (Kar.et Kir.) Sch.-Bip. of the Asteraceae family. Its nature and flavor are slightly bitter and warm. Its functions and indications are warming the kidney and assisting yang, dispelling wind and dampness, and promoting menstruation and blood circulation. It is used for wind-cold-damp arthritis, rheumatoid arthritis, cold pain in the lower abdomen, and irregular menstruation.

[0017] Phellinus igniarius: It is the dried fruiting body of Sanghuangporus vaninii (Ljub) LWZhou & Y.C.Dai. Its nature and flavor: pungent, slightly bitter, cold; it enters the liver, stomach, and large intestine meridians; its functions and indications are to soften and dissipate lumps, promote blood circulation and remove blood stasis, clear the stomach, and stop diarrhea. It is used for accumulation of masses, scrofula, metrorrhagia, leukorrhea, stomach heat and vomiting, damp-heat diarrhea, and bleeding from trauma.

[0018] Dandelion: This product is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum borealisinense Kitam. or several plants of the same genus in the Asteraceae family; it is bitter, sweet and cold in nature and enters the liver and stomach meridians. Its functions and indications are clearing away heat and detoxifying, reducing swelling and dispersing stagnation, and promoting diuresis and relieving stranguria. It is used for carbuncle, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, and hot stranguria with astringent pain.

[0019] Ganoderma lucidum: This product is the dried fruiting body of the Polyporaceae fungus Ganoderma lucidum (Leyss.ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang; its nature and flavor are sweet and mild; it enters the heart, lung, liver and kidney meridians; its functions and indications are to replenish qi and calm the mind, relieve cough and relieve asthma; it is used for restlessness, insomnia and palpitations, lung deficiency cough and asthma, fatigue and shortness of breath, and loss of appetite.

[0020] Red ginseng: This product is the dried root and rhizome of the cultivated product of Panax ginseng CAMey. of the Araliaceae family. It is sweet and slightly bitter in nature and enters the spleen, lung, heart and kidney meridians. Its functions and indications are to replenish vital energy, restore the pulse and consolidate the body, and replenish qi and retain blood. It is used for physical weakness and fainting, cold limbs and weak pulse, qi and blood not being able to be retained, and metrorrhagia and bleeding.

[0021] Rabdosia rubescens: This product is the dried aerial part of the Lamiaceae plant Rabdosia rubescens (Hemsl.) Hara; it is sweet, slightly cold, bitter in nature, and enters the lung, stomach, and liver meridians; its functions and indications are clearing away heat and detoxifying, promoting blood circulation and relieving pain. It is used for sore throat, lumps, and snake and insect bites.

[0022] Turmeric: This product is the dried rhizome of Curcuma longa L., a plant of the ginger family; its nature and flavor: pungent, warm, bitter, and enters the spleen and liver meridians; its functions and indications: breaking blood and promoting qi, dredge menstruation and relieve pain. It is used for chest and flank pain, chest obstruction and heart pain, dysmenorrhea and amenorrhea, masses, rheumatic shoulder and arm pain, and swelling and pain caused by falls.

[0023] Pine needles: dried leaves of Pinus massoniana Lamb.; bitter, warm; heart and spleen meridians; functions and indications: dispelling wind and dampness, promoting blood circulation and calming the mind. Used for rheumatic pain, traumatic injury, insomnia, etc.

[0024] Scrophularia: This product is the dried root of Scrophularia ningpoensis Hemsl. of the Scrophulariaceae family; its nature and flavor are sweet, bitter, and salty, and it enters the lung, stomach, and kidney meridians; its functions and indications are clearing away heat and cooling blood, nourishing yin and reducing fire, and detoxifying and dispersing stagnation. It is used for heat entering the blood, fever toxicity causing spots, febrile disease damaging yin, red tongue and thirst, body fluid damage and constipation, bone steaming and fatigue cough, red eyes, sore throat, diphtheria, scrofula, carbuncle, swelling and sore.

[0025] Coptis chinensis: This product is the dried rhizome of Coptis chinensis Franch, Coptisdeltoidea CYCheng et Hsiao or Coptis teeta Wall. of the Ranunculaceae family. It is bitter and cold in nature and enters the heart, spleen, stomach, liver, gallbladder and large intestine meridians. Its functions and indications are clearing away heat and dampness, purging fire and detoxifying. It is used for damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, restlessness and insomnia, palpitations, vomiting and bleeding due to blood heat, red eyes, toothache, thirst, carbuncle, furuncle; external treatment of eczema, wet sores and pus in the ear canal.

[0026] This prescription adopts the principle of one consolidation and one attack. One consolidation is for consolidating the foundation. It mainly uses Ganoderma lucidum, Tianshan Saussurea, and red ginseng, which have the effects of replenishing qi and calming the mind, replenishing qi and warming the kidney and assisting yang, and promoting blood circulation. The honey pills made of it have a certain effect of increasing the curative effect of consolidating the foundation; one attack is for attacking, and it mainly uses dandelion, mulberry, turmeric, winter rubescens, etc., which have the effects of clearing heat and detoxifying, softening and dispersing nodules, and promoting blood circulation and relieving pain; this prescription has one consolidation and one attack, attacking without hurting the foundation, consolidating the foundation and benefiting the attack, and the two have the effects of clearing heat and detoxifying, softening and dispersing nodules, replenishing qi and promoting blood circulation and relieving pain. In this prescription, mulberry is sweet and bitter in taste and cold in nature, and has the effects of promoting blood circulation and stopping bleeding, softening and dispersing nodules; dandelion is bitter in taste and cold in nature, and has the effects of clearing heat and detoxifying, reducing swelling and dispersing nodules. The two are the main medicines, with the effects of clearing heat and detoxifying, softening and dispersing nodules. Modern pharmacological studies have shown that the two drugs have obvious anti-tumor activity and inhibit tumor cell proliferation. Ganoderma lucidum, Tianshan Saussurea, and red ginseng have the effects of replenishing qi and calming the mind, invigorating qi and warming the kidney and supporting yang, and promoting blood circulation, which are helpful to replenish qi and support yang and enhance resistance; winter rubescens and turmeric clear away heat and detoxify, promote blood circulation and relieve pain, and break blood and promote qi circulation, and are all ministerial drugs. Coptis chinensis clears heat and dries dampness, purges fire and detoxifies; Scrophularia ningpoensis clears heat and cools blood, nourishes yin and reduces fire, and detoxifies and disperses knots; pine needles dispel wind and dampness, promote blood circulation and calm the mind. The three medicines are used together to play the role of clearing heat and purging fire, removing dampness and detoxifying, and are adjuvant drugs. Looking at the whole prescription, the monarch and ministers work together, and the ministers and assistants coordinate to play the role of clearing heat and detoxifying, softening and dispersing knots, replenishing qi and promoting blood circulation and relieving pain. The experimental results of the present invention show that the raw materials of this prescription cooperate with each other to achieve unexpected anti-tumor and anti-liver damage technical effects.

[0027] In a second aspect, the present invention provides a use of the traditional Chinese medicine composition described in the first aspect.

[0028] A use of the traditional Chinese medicine composition according to the first aspect in preparing a drug for preventing or treating liver cancer and / or a drug for resisting liver damage.

[0029] In a third aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect.

[0030] In some embodiments, a method for preparing the Chinese medicine composition of the first aspect, wherein the Chinese medicine composition is a pill, comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) sterilizing the drug powder; (3) The sterilized powder in step (2) is added with refined honey and water to make pills to obtain the pharmaceutical composition.

[0031] In some embodiments, the method for preparing refined honey is: take honey, heat it with steam until it boils, and refine it until the temperature of the honey is 110-120°C.

[0032] In some embodiments, a method for preparing the Chinese medicine composition of the first aspect, wherein the Chinese medicine composition is a powder, comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) Sterilizing the drug powder to obtain the drug composition.

[0033] In some embodiments, a method for preparing the Chinese medicine composition of the first aspect, wherein the Chinese medicine composition is a tablet, comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) sterilizing the drug powder, mixing it with pharmaceutically acceptable excipients, and tableting to obtain the Chinese medicine composition.

[0034] In some embodiments, a method for preparing the Chinese medicine composition of the first aspect, wherein the Chinese medicine composition is a capsule, comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) sterilizing the drug powder and filling capsules to obtain the Chinese medicine composition.

[0035] In some embodiments, the sieving in any of the foregoing methods comprises sieving through a 80-mesh to 120-mesh screen. In some embodiments, the sieving in any of the foregoing methods comprises sieving through a 80-mesh, 100-mesh or 120-mesh screen.

[0036] In some embodiments, the particle size D90 distribution range of the drug powder in any of the above methods is 130 μm-145 μm. In some embodiments, the particle size D90 distribution range of the drug powder in any of the above methods is 130 μm, 135 μm, 140 μm or 145 μm.

[0037] In some embodiments, the sterilization in any of the aforementioned methods comprises a high temperature instantaneous sterilization method.

[0038] In some embodiments, the sterilization temperature of the high temperature instantaneous sterilization method is 140° C.-180° C. In some embodiments, the sterilization temperature of the high temperature instantaneous sterilization method is 140° C., 150° C., 160° C., 170° C. or 180° C.

[0039] In some embodiments, the sterilization time of the high temperature instantaneous sterilization method is 7 seconds to 15 seconds. In some embodiments, the sterilization time of the high temperature instantaneous sterilization method is 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds or 15 seconds.

[0040] Beneficial Effects Compared with the prior art, the technical solution provided by the present invention has at least one of the following beneficial technical effects: (1) In the in vitro anti-liver cancer cell experiment, compared with the Chinese medicine composition lacking a certain raw material or using only one raw material, the Chinese medicine composition containing all the raw materials provided by the present invention has a much higher inhibition rate on the growth of in vitro liver cancer cells than the in vitro growth inhibition rate of liver cancer cells of Rubescens at the same dosage concentration and the in vitro growth inhibition rate of liver cancer cells of other raw materials at the same dosage concentration, the in vitro growth inhibition rate of liver cancer cells of pine needles at the same dosage concentration and the in vitro growth inhibition rate of liver cancer cells of other raw materials at the same dosage concentration, the in vitro growth inhibition rate of liver cancer cells of Scrophularia ningpoensis at the same dosage concentration and the in vitro growth inhibition rate of liver cancer cells of other raw materials at the same dosage concentration, and the in vitro growth inhibition rate of liver cancer cells of turmeric at the same dosage concentration. The inhibition rate of in vitro liver cancer cell growth is the same as the in vitro liver cancer cell growth inhibition rate of other raw materials with the same dosage concentration, which indicates that the inhibition rate of the traditional Chinese medicine composition containing all the raw materials provided by the present invention on the in vitro liver cancer cell growth is much higher than the theoretical inhibition rate of in vitro liver cancer cell growth of wintergrass combined with other raw materials of the present invention, the theoretical inhibition rate of in vitro liver cancer cell growth of pine needles combined with other raw materials of the present invention, the theoretical inhibition rate of in vitro liver cancer cell growth of Scrophularia combined with other raw materials of the present invention, and the theoretical inhibition rate of in vitro liver cancer cell growth of turmeric combined with other raw materials of the present invention, which indicates that the raw materials in the traditional Chinese medicine composition containing all the raw materials provided by the present invention synergistically improve the pharmacological activity of inhibiting the growth of liver cancer cells, and have unexpected technical effects.

[0041] (2) In the in vivo anti-liver cancer experiment, compared with the Chinese medicine composition lacking a certain raw material or using only one raw material, the Chinese medicine composition containing all the raw materials provided by the present invention has a much higher inhibition rate on the growth of liver cancer cells in vivo than the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of wintergrass and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of other raw materials, the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of pine needles and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of other raw materials, the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of Scrophularia ningpoensis and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of other raw materials, and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of turmeric and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of turmeric. This shows that the inhibition rate of the Chinese medicine composition containing all the raw materials provided by the present invention on the growth of liver cancer cells in vivo is much higher than the theoretical inhibition rate of liver cancer cells in vivo when wintergrass is combined with other raw materials of the present invention, the theoretical inhibition rate of liver cancer cells in vivo when pine needles are combined with other raw materials of the present invention, the theoretical inhibition rate of liver cancer cells in vivo when Scrophularia ningpoensis is combined with other raw materials of the present invention, and the theoretical inhibition rate of liver cancer cells in vivo when turmeric is combined with other raw materials of the present invention. This shows that the raw materials in the Chinese medicine composition containing all the raw materials provided by the present invention synergistically improve the pharmacological activity of inhibiting the growth of liver cancer cells in vivo, and have unexpected technical effects.

[0042] (3) The Chinese medicine composition provided by the present invention can not only protect liver cells from damage, but also significantly inhibit the growth of liver cancer cells, and has excellent technical effects.

[0043] (4) Compared with other formulations in the prior art, the present invention has low cost, high safety and simple preparation.

[0044] Terminology In the above text of the present invention, regardless of whether the words "about" or "approximately" are used, all the numbers disclosed herein are approximate values. Based on the disclosed numbers, the value of each number may vary by less than ±10% or reasonable differences considered by those skilled in the art, such as ±1%, ±2%, ±3%, ±4% or ±5%.

[0045] The terms "optional", "optional" or "optionally" mean that the subsequently described event or circumstance may but need not occur.

[0046] The term "and / or" should be understood to mean any one of the optional items or a combination of any two or more of the optional items.

[0047] The mesh size standard of the sieve described in the present invention is the mesh size standard specified in the general rules of Part II of the 2020 edition of the Chinese Pharmacopoeia.

[0048] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction. DETAILED DESCRIPTION

[0049] In order to enable those skilled in the art to better understand the technical solution of the present invention, some non-limiting embodiments are further disclosed below to further illustrate the present invention in detail.

[0050] The reagents used in the present invention can be purchased from the market or prepared by the method described in the present invention.

[0051] The term "crude drug" refers to the medicinal materials in the traditional Chinese medicine composition (excluding auxiliary materials (such as refined honey)). The crude drugs in the present invention are Tianshan Saussurea, Taraxacum, Phellinus linteus, Ganoderma lucidum, Red ginseng, Rubescens herb, Curcuma longa, Pine needles, Scrophularia ningpoensis and Coptis chinensis.

[0052] Example 1: Chinese medicine composition A Chinese medicine composition for treating liver cancer and a preparation method thereof. The raw materials are: 3kg of Tianshan Saussurea, 20kg of Taraxacum mongolicum, 15kg of Phellinus linteus, 15kg of Ganoderma lucidum, 1kg of Red Ginseng, 5kg of Rabdosia rubescens, 5kg of Curcuma longa, 1kg of Pine Needle, 1kg of Scrophularia ningpoensis, and 2kg of Coptis chinensis.

[0053] The preparation method of the above-mentioned Chinese medicine composition is as follows: (1) respectively taking Saussurea involucrata, dandelion, Phellinus linteus, Ganoderma lucidum, red ginseng, Rubescens herb, turmeric, pine needle, Scrophularia ningpoensis, and Coptis chinensis, coarsely grinding them, then finely grinding them, passing them through an 80-mesh sieve, and mixing them to obtain medicinal powder; (2) Mix the above-mentioned drug powders and sterilize them in a high-temperature instantaneous sterilizer. The temperature is set to 140°C and the sterilization time is set to 15 seconds.

[0054] (3) Take honey, heat it with steam until it boils, and refine it until the temperature of the honey reaches 117°C to obtain refined honey; (4) The sterilized mixed powder is mixed with refined honey and water to make pills to obtain the pharmaceutical composition.

[0055] Example 2: Chinese medicine composition A Chinese medicine composition for treating liver cancer and a preparation method thereof. The raw materials are: 5kg of Tianshan Saussurea, 25kg of Taraxacum mongolicum, 19kg of Phellinus linteus, 19kg of Ganoderma lucidum, 3kg of Red Ginseng, 10kg of Rubescens herb, 10kg of Curcuma longa, 2kg of Pine needles, 3kg of Scrophularia ningpoensis, and 4kg of Coptis chinensis.

[0056] The preparation method is the same as that of Example 1.

[0057] Example 3: Chinese medicine composition A Chinese medicine composition for treating liver cancer and a preparation method thereof. The raw materials are: 7kg of Tianshan Saussurea, 30kg of Taraxacum mongolicum, 25kg of Phellinus igniarius, 25kg of Ganoderma lucidum, 5kg of Red Ginseng, 15kg of Rabdosia rubescens, 15kg of Curcuma longa, 3kg of Pine needles, 5kg of Scrophularia ningpoensis, and 6kg of Coptis chinensis.

[0058] The preparation method is the same as that of Example 1.

[0059] Comparative Example 1-Comparative Example 8: Comparative Example 1: The difference from Example 1 is that Rubescens rubescens is not added.

[0060] Comparative Example 2: The difference from Example 1 is that all raw materials are replaced by Rubescens rubescens.

[0061] Comparative Example 3: The difference from Example 1 is that pine needles are not contained.

[0062] Comparative Example 4: The difference from Example 1 is that all raw materials are replaced by pine needles.

[0063] Comparative Example 5: The difference from Example 1 is that Scrophularia ningpoensis is not contained.

[0064] Comparative Example 6: The difference from Example 1 is that all raw materials are replaced with Scrophularia ningpoensis.

[0065] Comparative Example 7: The difference from Example 1 is that turmeric is not added.

[0066] Comparative Example 8: The difference from Example 1 is that all raw materials are replaced by turmeric.

[0067] Test Example 1: Hepatoma Cell Inhibition Rate (1) Grouping: Blank control group: DMEM medium was used as the drug administration reagent; Example 1 Chinese medicine composition group low concentration group (0.1 g crude drug / ml): take the Chinese medicine composition obtained in Example 1, dilute it with DMEM medium to 0.1 g crude drug / ml and use it as a dosing agent; Medium concentration group of the Chinese medicine composition group in Example 1 (0.2 g crude drug / ml): the Chinese medicine composition obtained in Example 1 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Example 1 Chinese medicine composition group High concentration group (0.3 g crude drug / ml): Take the Chinese medicine composition obtained in Example 1, dilute it with DMEM medium to 0.3 g crude drug / ml and use it as a dosing agent; Comparative Example 1 (0.2 g crude drug / ml): the Chinese medicine composition obtained in Comparative Example 1 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 2 (0.2 g crude drug / ml): The Chinese medicine composition obtained in Comparative Example 2 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 3 (0.2 g crude drug / ml): The Chinese medicine composition obtained in Comparative Example 3 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 4 (0.2 g crude drug / ml): The Chinese medicine composition obtained in Comparative Example 4 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 5 (0.2 g crude drug / ml): The Chinese medicine composition obtained in Comparative Example 5 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 6 (0.2 g crude drug / ml): The Chinese medicine composition obtained in Comparative Example 6 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 7 (0.2 g crude drug / ml): the Chinese medicine composition obtained in Comparative Example 7 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent; Comparative Example 8 (0.2 g crude drug / ml): The Chinese medicine composition obtained in Comparative Example 8 was diluted with DMEM medium to 0.2 g crude drug / ml and used as a dosing agent.

[0068] (2) Operation HepG2 cells (Hunan Slake Jingda Experimental Animal Co., Ltd.) of the human liver cancer cell line were inoculated into a culture dish and cultured in an incubator at 37°C and 5% CO2. The experiment was performed when the cells grew to the logarithmic growth phase. The HepG2 cells were divided into 10 groups, and the grouping was described in the above step "(1) Grouping". The corresponding drug administration reagent was added to each group. After 24 hours of treatment, CCK-8 reagent was added to the cells in each group, and the absorbance (OD) value was detected on an ELISA instrument, and the cell growth inhibition rate was calculated. The results are shown in Table 2.

[0069] Table 2: Results of liver cancer cell growth inhibition rate Group Hepatocellular carcinoma cell growth inhibition rate% Blank control group / Example 1 Chinese medicine composition group low concentration group (0.1g crude drug / ml) 28.1 Example 1 Chinese medicine composition group medium concentration group (0.2g crude drug / ml) 41.6 Example 1 Chinese medicine composition group high concentration group (0.3g crude drug / ml) 41.3 Comparative Example 1 (0.2 g crude drug / ml) 21.9 Comparative Example 2 (0.2 g crude drug / ml) 2.6 Comparative Example 3 (0.2 g crude drug / ml) 31.4 Comparative Example 4 (0.2 g crude drug / ml) 3.5 Comparative Example 5 (0.2 g crude drug / ml) 29.8 Comparative Example 6 (0.2 g crude drug / ml) 2.5 Comparative Example 7 (0.2 g crude drug / ml) 22.5 Comparative Example 8 (0.2 g crude drug / ml) 3.1 Calculation formula: Hepatoma cell growth inhibition rate % = (OD 对照组 -OD 中药组合物组 ) / OD 对照组☓100% Conclusion: In the in vitro anti-liver cancer cell experiment, compared with the Chinese medicine composition lacking a certain raw material or using only one raw material, the Chinese medicine composition containing all the raw materials provided by the present invention has a much higher inhibition rate on the growth of in vitro liver cancer cells than the in vitro growth inhibition rate of liver cancer cells of Rubescens at the same dosage concentration and the in vitro growth inhibition rate of liver cancer cells of other raw materials at the same dosage concentration, the in vitro growth inhibition rate of liver cancer cells of pine needles at the same dosage concentration and the in vitro growth inhibition rate of liver cancer cells of other raw materials at the same dosage concentration, the in vitro growth inhibition rate of liver cancer cells of Scrophularia ningpoensis at the same dosage concentration and the in vitro growth inhibition rate of liver cancer cells of other raw materials at the same dosage concentration, and the in vitro growth inhibition rate of liver cancer cells of turmeric at the same dosage concentration. The inhibition rate of in vitro liver cancer cell growth is the same as the in vitro liver cancer cell growth inhibition rate of other raw materials with the same dosage concentration, which indicates that the inhibition rate of the traditional Chinese medicine composition containing all the raw materials provided by the present invention on the in vitro liver cancer cell growth is much higher than the theoretical inhibition rate of in vitro liver cancer cell growth of wintergrass combined with other raw materials of the present invention, the theoretical inhibition rate of in vitro liver cancer cell growth of pine needles combined with other raw materials of the present invention, the theoretical inhibition rate of in vitro liver cancer cell growth of Scrophularia combined with other raw materials of the present invention, and the theoretical inhibition rate of in vitro liver cancer cell growth of turmeric combined with other raw materials of the present invention, which indicates that the raw materials in the traditional Chinese medicine composition containing all the raw materials provided by the present invention synergistically improve the pharmacological activity of inhibiting the growth of liver cancer cells, and have unexpected technical effects.

[0070] Test Example 2: Anti-liver damage experiment 1. Experimental animals: Breed / strain: SD rat; Grade: SPF grade; Gender: male; Number of animals used: 32; Weight range: 140.7-170.0 g; Supplier: Hunan Slake Jingda Experimental Animal Co., Ltd.

[0071] 2. Test methods (1) Test article dosage design and drug preparation The proposed clinical dosage of the Chinese medicine combination of this product is 16g of crude drug / day. According to the conversion table of equivalent doses between animal species based on body surface area in the fourth edition of Pharmacological Experimental Methodology edited by Wei Wei, the rat equivalent dose is 16×0.018÷0.2=1.44g crude drug / kg. This experiment selected the maximum clinical intended dose of .5, 1, and 2 times the rat equivalent dose as the low, medium, and high dose groups, with dosages of 0.72g crude drug / kg, 1.44g crude drug / kg, and 2.88g crude drug / kg, respectively.

[0072] Drug preparation: Weigh the Chinese medicine composition pills obtained in Example 1, add pure water and stir to mix, and prepare into 0.036g crude drug / mL, 0.072g crude drug / mL, and 0.144g crude drug / mL medicinal solutions respectively, and stir evenly before use.

[0073] Table 3: Dosage design table Group Dosage Dosing concentration Dosing volume ml / 100g Number of animals Control group — — 2 8 Example 1 Chinese medicine composition group ① 0.72g crude drug / kg 0.036g crude drug / mL 2 8 Example 1 Chinese medicine composition group ② 1.44g crude drug / kg 0.072g crude drug / mL 2 8 Example 1 Chinese medicine composition group ③ 2.88g crude drug / kg 0.144g crude drug / mL 2 8 (2) Modeling, grouping and drug administration: 32 SD male rats (DEN-induced liver cancer model rats) were randomly divided into control group, Chinese medicine composition group ①, Chinese medicine composition group ②, and Chinese medicine composition group ③ according to body weight, with 8 rats in each group. The rats in the control group were free to drink tap water and were gavaged with 0.9% saline at 2ml / 100g once a day. The rats in the Chinese medicine composition group were free to drink water, and the Chinese medicine composition group was gavaged with the corresponding dose of drug solution (Table 3) at 2ml / 100g, once a day for 30 consecutive days.

[0074] (3) Testing indicators: The animals were weighed first, and then 4 ml of blood was collected from each animal by decapitation and centrifugation. The serum was collected and the levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) were measured using an automatic biochemical analyzer.

[0075] (4) Test results: The results of liver function indicators AST, ALT and ALP of the control group and the Chinese medicine combination group are shown in Table 4.

[0076] Table 4: Liver function index results Group n AST(U / L) ALT(U / L) ALP(U / L) Control group 8 356±75.74 254.33±95.41 286.01±92.01 Example 1 Chinese medicine composition group ① 8 267±57.08 175±56.85 196±45.62 Example 1 Chinese medicine composition group ② 8 185±52.12 105±43.77 158±40.03 Example 1 Chinese medicine composition group ③ 8 191±84.91 106±35.24 166±32.71 (5) Results analysis Compared with the control group, the liver function indexes AST, ALT and ALP in the Chinese medicine combination group were significantly reduced, among which the indexes in Chinese medicine combination group ② and Chinese medicine combination group ③ were significantly decreased (P<0.05), and all of them were reduced to the normal range (the AST, ALT and ALP values ​​of normal rats were: 69.7-322.9 U / L, 33.7-98.7U / L, 1.3-210.0 U / L, respectively (see the literature "Sun Jin, Xu Yuanhong. Establishment of reference ranges for common hematological test indicators in SD rats. Clinical Blood Transfusion and Laboratory [J]. 2008, (3): 253-255."). The results of AST and ALP in Chinese medicine combination group ① were already in the normal range, and ALT had a trend towards the normal value; the results of AST, ALT and ALP in Chinese medicine combination groups ② and ③ were already in the normal range.

[0077] (6) Conclusion Based on the results of Experimental Examples 1 and 2, it can be seen that the Chinese medicine composition provided by the present invention can not only protect liver cells from damage, but also significantly inhibit the growth of liver cancer cells, and has excellent technical effects.

[0078] Test Example 3: Anti-liver cancer experiment Establishment of human liver cancer xenograft tumor model in nude mice: 4-5 week-old female BALB / c nude mice were subcutaneously inoculated with Hep-3B cells in the left axilla. Each nude mouse was injected with 4×10 6 The tumor volume reaches 100-300mm 3 The nude mice were randomly divided into 12 groups, with 10 animals in each group.

[0079] Drug preparation: Weigh the Chinese medicine composition pills obtained in the above examples or comparative examples respectively, add pure water and stir to mix, prepare a drug solution with a concentration of 0.072 g crude drug / mL, and stir evenly before use.

[0080] The 12 groups were divided into 1 model group and 11 drug-administered groups. Drugs were administered by gavage. The grouping of each group is shown in Table 5. Each group was administered once a day for 3 consecutive weeks (21 days). The animals were observed once a day and their clinical status was recorded. The long diameter and short diameter of the tumor were tested twice a week, and the tumor volume and tumor inhibition rate (%) were calculated according to the following formula.

[0081] Tumor volume V = 0.5 × a × b × b, Where a is the long diameter of the tumor and b is the short diameter of the tumor.

[0082] Tumor inhibition rate (%) = (model group V - drug administration group V) / model group V × 100%.

[0083] After 21 consecutive days of administration, the tumor volume test results are shown in Table 6.

[0084] Table 5: Grouping Group Administering medication Dosage Dosing concentration Dosing volume ml / 100g Number of animals Model Group water — — 2 10 Example 1 Dosage Group Example 1 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Example 2 Dosage Group Example 2 Obtained Chinese Medicine Composition 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Example 3 Administration Group Example 3 Obtained Chinese medicine composition 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 1: Drug administration group Comparative Example 1 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 2: Drug administration group Comparative Example 2 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 3: Administration Group Comparative Example 3 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 4: Administration Group Comparative Example 4 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 5: Administration Group Comparative Example 5 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 6: Drug administration group Comparative Example 6 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 7: Administration Group Comparative Example 7 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Comparative Example 8: Administration Group Comparative Example 8 Chinese medicine composition obtained 1.44g crude drug / kg 0.072g crude drug / mL 2 10 Table 6: Tumor volume and tumor inhibition rate after 21 days of administration Group Tumor volume (mm3) Tumor inhibition rate (%) Model Group 1125 / Example 1 Dosage Group 501 55.5 Example 2 Dosage Group 526 53.2 Example 3 Administration Group 517 54.0 Comparative Example 1: Drug administration group 809 28.1 Comparative Example 2: Drug administration group 1075 4.4 Comparative Example 3: Administration Group 758 32.6 Comparative Example 4: Administration Group 1052 6.5 Comparative Example 5: Administration Group 767 31.8 Comparative Example 6: Drug administration group 1064 5.4 Comparative Example 7: Administration Group 893 20.6 Comparative Example 8: Administration Group 1081 3.9 Conclusion: It can be seen from the results in Table 6 that in the in vivo anti-liver cancer experiment, compared with the Chinese medicine composition lacking a certain raw material or using only one raw material, the Chinese medicine composition containing all the raw materials provided by the present invention has a much higher inhibition rate on the growth of liver cancer cells in vivo than the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of wintergrass and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of other raw materials, the in vivo growth inhibition rate of liver cancer cells in vivo of pine needles and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of other raw materials, the in vivo growth inhibition rate of liver cancer cells in vivo of Scrophularia ningpoensis and the in vivo growth inhibition rate of liver cancer cells in vivo of the same dosage of other raw materials, and the in vivo growth inhibition rate of liver cancer cells in vivo of turmeric at the same dosage. The in vivo liver cancer cell growth inhibition rate is the same as the in vivo liver cancer cell growth inhibition rate of other raw materials with the same dosage, which indicates that the inhibition rate of the traditional Chinese medicine composition containing all the raw materials provided by the present invention on the in vivo liver cancer cell growth is much higher than the theoretical in vivo liver cancer cell growth inhibition rate of wintergrass combined with other raw materials of the present invention, the theoretical in vivo liver cancer cell growth inhibition rate of pine needles combined with other raw materials of the present invention, the theoretical in vivo liver cancer cell growth inhibition rate of Scrophularia combined with other raw materials of the present invention, and the theoretical in vivo liver cancer cell growth inhibition rate of turmeric combined with other raw materials of the present invention, which indicates that the raw materials in the traditional Chinese medicine composition containing all the raw materials provided by the present invention synergistically improve the pharmacological activity of inhibiting the growth of liver cancer cells in vivo, and have unexpected technical effects.

[0085] The method of the present invention has been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein within the content and scope of the present invention to implement and apply the technology of the present invention. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters. It is particularly important to point out that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The ingredients include: Tianshan Snow Lotus, Dandelion, Coriolus linteus, Ganoderma lucidum, Red Ginseng, Rubescens, Turmeric, Pine Needle, Scrophularia and Coptis chinensis.

2. The Chinese medicine composition according to claim 1, wherein the weight parts of each raw material in the Chinese medicine composition are: 3-7 weight parts of Tianshan Snow Lotus, 20-30 weight parts of Taraxacum, 15-25 weight parts of Phellinus linteus, 15-25 weight parts of Ganoderma lucidum, 1-5 weight parts of red ginseng, 5-15 weight parts of Rubescens, 5-15 weight parts of Curcuma, 1-3 weight parts of pine needles, 1-5 weight parts of Scrophularia and 2-6 weight parts of Coptis chinensis.

3. The Chinese medicine composition according to claim 1, wherein the Chinese medicine composition is composed of the following raw materials in parts by weight: 3 parts by weight of Saussurea involucrata, 20 parts by weight of Taraxacum mongolicum, 15 parts by weight of Phellinus linteus, 15 parts by weight of Ganoderma lucidum, 1 part by weight of Red Ginseng, 5 parts by weight of Rubescens rubescens, 5 parts by weight of Curcuma longa, 1 part by weight of Pine Needle, 1 part by weight of Scrophularia ningpoensis, and 2 parts by weight of Coptis chinensis; or 5 parts by weight of Saussurea involucrata, 25 parts by weight of Taraxacum mongolicum, 19 parts by weight of Phellinus linteus, 19 parts by weight of Ganoderma lucidum, 3 parts by weight of Red Ginseng, 10 parts by weight of Rubescens rubescens, 10 parts by weight of Curcuma longa, 2 parts by weight of Pine Needle, 3 parts by weight of Scrophularia ningpoensis, and 4 parts by weight of Coptis chinensis; or 7 parts by weight of Saussurea involucrata, 30 parts by weight of Taraxacum mongolicum, 25 parts by weight of Phellinus linteus, 25 parts by weight of Ganoderma lucidum, 5 parts by weight of Red Ginseng, 15 parts by weight of Rubescens rubescens, 15 parts by weight of Curcuma longa, 3 parts by weight of Pine needles, 5 parts by weight of Scrophularia ningpoensis and 6 parts by weight of Coptis chinensis.

4. The Chinese medicine composition according to any one of claims 1 to 3, wherein the dosage form of the Chinese medicine composition is tablets, capsules, granules, pills, paste or powder.

5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for preventing or treating liver cancer and / or a drug for resisting liver damage.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is a pill, and the preparation method of the Chinese medicine composition comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) sterilizing the drug powder; (3) The sterilized powder in step (2) is added with refined honey and water to make pills to obtain the pharmaceutical composition.

7. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is a powder, and the preparation method of the Chinese medicine composition comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) Sterilizing the drug powder to obtain the drug composition.

8. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is a tablet, and the preparation method of the Chinese medicine composition comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) sterilizing the drug powder, mixing it with pharmaceutically acceptable excipients, and tableting to obtain the Chinese medicine composition.

9. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is a capsule, and the preparation method of the Chinese medicine composition comprises the following steps: (1) Grinding, sieving and mixing the raw materials to obtain drug powder; (2) sterilizing the drug powder and filling capsules to obtain the Chinese medicine composition.