A pharmaceutical composition for preventing and / or treating hepatocarcinoma and its cachexia, and a preparation method and application thereof

Abstract

The application provides a kind of drug composition for preventing and / or treating liver cancer and cachexia and its preparation method and application. Wherein, by weight parts, the drug composition is composed of the following components: yam 1-10 parts, ophiopogon 1-10 parts, ginseng 2-20 parts, yiyi 1-10 parts, dried tangerine or orange peel 1.5-15 parts. The drug composition provided by the application can not only reduce the tumor size of liver cancer patients, but also increase muscle and fat of patients and increase body weight, thereby playing a role in reversing cachexia and improving nutrition, and has a good curative effect on preventing or treating liver cancer cachexia.

Description

Technical Field

[0001] The present invention belongs to the fields of traditional Chinese medicine and food. Specifically, the present invention relates to a pharmaceutical composition for preventing and / or treating liver cancer and its cachexia, as well as a preparation method and use thereof. Background Art

[0002] Liver cancer-related cachexia is a major factor affecting the quality of life of patients with advanced liver cancer, and malignant tumors are prone to develop cachexia in the late stage of the disease. China is a country with a high incidence of liver cancer. According to the latest global cancer burden data released by the International Agency for Research on Cancer of the World Health Organization in December 2020, the number of new cases of primary liver cancer in China accounted for 42.5% of the global total in the past five years, with an annual average of 995,000 new cases. As a common malignant tumor in China, liver cancer has high malignancy and rapid development, and its incidence and mortality show an upward trend year by year. Due to the insidious onset of liver cancer, most clinical diagnoses are made at the advanced malignant stage, making the five-year survival rate of patients only 14.1%, which seriously affects the health of Chinese people.

[0003] Most traditional Chinese medicine compositions currently on the market are mainly focused on anti-tumor efficacy, and rarely have the effect of treating cachexia. For example, patent application CN110882298A discloses an anti-tumor traditional Chinese medicine composition, its preparation method and use. The traditional Chinese medicine composition is prepared from Gerbera anandria and Gentiana rhodantha as raw materials, and can be applied to the preparation of anti-tumor drugs and foods, which can significantly inhibit the invasion and metastasis of hepatocellular carcinoma and non-small cell lung cancer. However, the traditional Chinese medicine composition does not show efficacy against liver cancer cachexia, such as increasing fat or muscle, and increasing body weight. Patent application CN113769044A discloses a traditional Chinese medicine composition for treating malignant tumors and a preparation method thereof. The traditional Chinese medicine composition comprises the following raw materials: Sargassum, Glycyrrhizae Radix et Rhizoma, Momordicae Semen, Trionycis Carapax, Hedyotis Diffusa, Paridis Rhizoma, Meretricis Concha, Zingiberis Rhizoma Recens, Scrophulariae Radix, Ostreae Concha, Fritillariae Cirrhosae Bulbus, Cremastrae Pseudobulbus. The traditional Chinese medicine composition is obtained by sequentially weighing the above raw materials, adding water for decoction, mixing and pulverizing, grinding, filtering and mixing. The traditional Chinese medicine composition can inhibit the growth of cancer cells with low toxic and side effects, but does not show effects in improving liver cancer cachexia such as improving appetite and body weight in patients.

[0004] In summary, there is currently no effective and convenient drug that exerts an anti-tumor effect while also having the effect of treating cachexia. Summary of the Invention

[0005] In view of the deficiencies of the prior art, the object of the present invention is to provide a pharmaceutical composition for preventing and / or treating liver cancer and its cachexia, as well as a preparation method and use thereof. The inventor found through research that the pharmaceutical composition of the present invention can not only reduce the tumor size of patients with liver cancer cachexia, but also increase the muscle, fat and body weight of patients, thereby reversing the disease and improving nutrition, and has good efficacy for preventing or treating liver cancer cachexia.

[0006] The above-mentioned objective of the present invention is achieved by providing the following technical solution:

[0007] In a first aspect, the present invention provides a pharmaceutical composition for the prevention and / or treatment of liver cancer and its cachexia, comprising, by weight, the following components: 1-10 parts of yam, 1-10 parts of ophiopogon japonicus, 2-20 parts of ginseng, 1-10 parts of coix seed, and 1.5-15 parts of dried tangerine peel.

[0008] Secondly, the present invention provides a food composition for improving liver cancer cachexia, which, by weight, consists of the following components: 1-10 parts of yam, 1-10 parts of Ophiopogon japonicus, 2-20 parts of ginseng, 1-10 parts of coix seed, and 1.5-15 parts of dried tangerine peel.

[0009] Preferably, the composition contains 5-10 parts by weight of yam, more preferably 10 parts.

[0010] Preferably, the composition contains 5-10 parts by weight of Ophiopogon japonicus, more preferably 10 parts.

[0011] Preferably, the composition contains 10-20 parts of ginseng, more preferably 20 parts, by weight.

[0012] Preferably, the composition contains 5-10 parts by weight of Job's tears, more preferably 10 parts.

[0013] Preferably, the composition contains 8-15 parts by weight of dried tangerine peel, more preferably 15 parts.

[0014] According to some embodiments of the present invention, the weight ratio of yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel contained in the composition is 2: 2: 4: 2: (3-4).

[0015] Thirdly, the present invention provides a pharmaceutical extract for the prevention and / or treatment of liver cancer and its cachexia, which is prepared from the pharmaceutical composition according to the first aspect of the present invention.

[0016] Fourthly, the present invention provides a food extract for improving liver cancer cachexia, which is prepared from the food composition described in the second aspect of the present invention.

[0017] Fifthly, the present invention provides a method for preparing a drug extract or food extract according to the third or fourth aspect of the present invention, comprising:

[0018] (a) Mix yam, ophiopogon japonicus, ginseng, coix seed, and dried tangerine peel, extract with solvent, and then concentrate and dry the resulting extract sequentially; or

[0019] (b) Extract yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel separately with solvent, then concentrate and dry the extracts obtained separately, and then mix them.

[0020] According to some embodiments of the present invention, in (a) or (b), the solvent is an aqueous solution of water and / or ethanol; preferably, the volume fraction of the aqueous solution of ethanol is 50-100%.

[0021] According to some embodiments of the present invention, in (a) or (b), the weight ratio of the extract to the solvent is 1:5-25, preferably 1:5-10.

[0022] According to some embodiments of the present invention, in (a) or (b), the extraction is selected from one or more of decoction extraction, maceration extraction and ultrasonic extraction.

[0023] Preferably, the decoction extraction is carried out under the following conditions: extraction temperature is 90-100℃; extraction is performed 1-5 times; and each extraction takes 2-4 hours.

[0024] Preferably, the extraction process includes soaking and heating extraction in sequence; more preferably, the soaking time is 12-24 hours; even more preferably, the heating extraction is carried out under the following conditions: extraction temperature is 90-100℃; extraction is performed 1-5 times; and each extraction takes 0.5-2 hours.

[0025] Preferably, the ultrasonic extraction is performed under the following conditions: ultrasonic frequency of 30-80 Hz; extraction temperature of 30-40℃; extraction times of 1-5 times; and extraction time of 1-4 hours per extraction.

[0026] Preferably, in step (a) or (b), the yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel are pulverized and sieved respectively before extraction; more preferably, the sieve mesh number is 50-200 mesh, preferably 100 mesh.

[0027] In a sixth aspect, the present invention provides a traditional Chinese medicine preparation for the prevention and / or treatment of liver cancer and its cachexia, comprising a pharmaceutical composition according to the first aspect of the present invention or a pharmaceutical extract according to the third aspect of the present invention, and optionally pharmaceutically acceptable excipients.

[0028] According to some embodiments of the present invention, the pharmaceutically acceptable excipient is selected from one or more of solvents, disintegrants, flavoring agents, preservatives, and colorants.

[0029] According to some embodiments of the present invention, the dosage form of the traditional Chinese medicine preparation is an oral preparation or an injectable preparation; more preferably, the oral preparation is selected from one or more of tablets, capsules, pills, granules, suspensions, drop pills and oral liquid preparations.

[0030] In a seventh aspect, the present invention provides a method for preparing a traditional Chinese medicine preparation according to the sixth aspect of the present invention, comprising: mixing a pharmaceutical composition according to the first aspect of the present invention or a pharmaceutical extract according to the third aspect of the present invention with an optional pharmaceutically acceptable excipient.

[0031] Eighthly, the present invention provides a food for improving liver cancer cachexia, comprising a food composition according to the second aspect of the present invention or a food extract according to the fourth aspect of the present invention, and optionally food-acceptable excipients.

[0032] According to some embodiments of the present invention, the food-acceptable excipients are selected from one or more of solvents, disintegrants, flavoring agents, preservatives, and colorants.

[0033] In a ninth aspect, the present invention provides a method for preparing a food according to the eighth aspect of the present invention, comprising: mixing a food composition according to the second aspect of the present invention or a food extract according to the fourth aspect of the present invention with optional food-acceptable excipients.

[0034] In a tenth aspect, the present invention provides the use of a pharmaceutical composition according to the first aspect of the present invention, a pharmaceutical extract according to the third aspect of the present invention, or a traditional Chinese medicine preparation according to the sixth aspect of the present invention in the preparation of a medicament for the prevention and / or treatment of liver cancer and its cachexia.

[0035] Eleventhly, the present invention provides the use of the food composition according to the second aspect of the present invention, the food extract according to the fourth aspect of the present invention, or the food according to the eighth aspect of the present invention in the preparation of a product for improving liver cancer cachexia.

[0036] According to some embodiments of the present invention, the symptoms of liver cancer cachexia are selected from one or more reductions in muscle, fat, and body weight.

[0037] The present invention has at least the following beneficial effects:

[0038] (1) The composition provided by the present invention can reduce the tumor size of liver cancer patients and increase the patient’s muscle and fat and weight, thereby reversing cachexia and improving nutrition, and has a good therapeutic effect on the prevention or treatment of liver cancer cachexia.

[0039] (2) The raw materials of the composition of the present invention are inexpensive and readily available, the preparation method is simple, and the administration is convenient.

[0040] (3) Through animal experiments, the inventors unexpectedly discovered that the pharmaceutical composition of the present invention performed well in improving liver cancer cachexia, and its effect was comparable to that of positive drugs with excellent efficacy. This strongly confirms that the pharmaceutical composition of the present invention has high feasibility and significant clinical application value in the treatment of liver cancer cachexia. Attached Figure Description

[0041] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings, wherein:

[0042] Figure 1 This is a schematic diagram showing the tumor growth status of mice in each group during animal experiments.

[0043] Figure 2 This is a schematic diagram of the tumor mass at the treatment endpoint in each group of mice during animal experiments.

[0044] Figure 3 This is a schematic diagram showing the changes in fat content in mice of different groups during animal experiments.

[0045] Figure 4 This is a schematic diagram showing the changes in receptor weight (including mouse body weight and tumor weight) in each group of mice during animal experiments.

[0046] Figure 5 This is a schematic diagram showing the changes in body weight of mice in each group during animal experiments.

[0047] Figure 6 This is a schematic diagram showing the changes in luciferase signal intensity in different groups of mice during animal experiments.

[0048] Figure 7 This is a schematic diagram showing the final tumor size of mice in each group during the animal experiment; compared with the model group, *p<0.05, **p<0.01;

[0049] Figure 8 This is a schematic diagram showing the ratio of body weight to tumor weight in mice of each group during animal experiments; where, compared with the model group, *p<0.05, **p<0.01, ***p<0.001, and ns indicates no significance;

[0050] Figure 9 Schematic diagram of pathological sections of white adipose tissue from mice in various groups during animal experiments;

[0051] Figure 10 This is a schematic diagram of pathological sections of brown adipose tissue from mice in various groups during animal experiments.

[0052] Figure 11 This is a schematic diagram of pathological sections of the thighs of mice in each group during animal experiments.

[0053] Figure 12This is a schematic diagram of pathological sections of the gastrocnemius muscle of mice in each group during animal experiments.

[0054] Figure 13 This is a schematic diagram showing the H&E staining results of liver cancer tissues from various groups of mice in animal experiments. Detailed Implementation

[0055] The present invention will be further described in detail below with reference to specific embodiments. The embodiments given are only for illustrating the present invention and are not intended to limit the scope of the present invention.

[0056] Experimental medicinal materials and reagents

[0057] The following examples use Chinese yam (scientific name: Dioscoreae Rhizoma) harvested from Shanxi Province, China; Ophiopogon japonicus (Linn. f.) Ker-Gawl. harvested from Guangdong Province, China; Panax ginseng (scientific name: Panax ginseng CA Mey.) harvested from Jilin Province, China; Coix lacryma-jobi (scientific name: Coicis Semen) harvested from Fujian Province, China; and Citrus reticulata Blanco (dried tangerine peel) harvested from Guangdong Province, China.

[0058] The liver cancer cell line PLC used in the following examples was purchased from ATCC, Inc., USA, and the liver cancer cell line MHCC-97L was obtained from the Department of Surgery, University of Hong Kong, China.

[0059] laboratory animals

[0060] The mice used in the following animal experiments were all Athymic nude mice, obtained from the Laboratory Animal Centre of the University of Hong Kong.

[0061] Example 1

[0062] (1) Grind the yam, ophiopogon japonicus, ginseng, coix seed and dried tangerine peel into powder and pass them through a 100-mesh sieve;

[0063] (2) Weigh 10 parts of yam, 10 parts of Ophiopogon japonicus, 20 parts of ginseng, 10 parts of coix seed and 15 parts of tangerine peel after sieving, mix them and add 5 times the total weight of the extract to a 50% ethanol aqueous solution. Extract the extract at room temperature for 2 hours at a frequency of 50 Hz to obtain a composite extract.

[0064] (3) The composite extract obtained in step (2) is concentrated and dried sequentially to obtain the composite extract.

[0065] Example 2

[0066] (1) Grind the yam, ophiopogon japonicus, ginseng, coix seed and dried tangerine peel into powder and pass them through a 100-mesh sieve;

[0067] (2) Weigh out 5 parts of yam, 5 parts of Ophiopogon japonicus, 10 parts of ginseng, 5 parts of coix seed and 8 parts of tangerine peel after sieving, mix them and add them to boiling water with a total weight of 6 times that of the extract to be extracted and decoct for 2 hours. Decoction is repeated 3 times, filtered, and the filtrates are combined to obtain the compound extract.

[0068] (3) The composite extract obtained in step (2) is concentrated and dried sequentially to obtain the composite extract.

[0069] Example 3

[0070] Preparation of tablets for treating liver cancer cachexia: Take the compound extract obtained in Example 2, add pharmaceutically acceptable excipients according to conventional process to prepare tablets, each tablet containing 0.5g of the compound extract, 3-4 tablets each time, 3 times a day.

[0071] Example 4

[0072] Preparation of pills for treating liver cancer cachexia: Take the compound extract obtained in Example 2, add pharmaceutically acceptable excipients according to conventional process to prepare pills, each pill containing 0.5g of the compound extract, 3-4 pills 3 times a day.

[0073] Example 5

[0074] Preparation of a health drink to improve symptoms of liver cancer cachexia: Take the compound extract obtained in Example 2, add food-acceptable excipients according to conventional process to prepare a health drink, each bottle 10ml, containing 0.3g of the compound extract, 2 bottles per day.

[0075] Comparative Example 1

[0076] The compound extract was prepared according to the method of Example 2, except that Ophiopogon japonicus and dried tangerine peel were not added.

[0077] Comparative Example 2

[0078] The compound extract was prepared according to the method of Example 2, the difference being that: by weight, the raw materials were 2 parts of yam, 30 parts of Ophiopogon japonicus, 25 parts of ginseng, 30 parts of coix seed, and 35 parts of dried tangerine peel.

[0079] animal experiments

[0080] The composite extracts obtained in Example 2 and Comparative Examples 1-2 were used to study the inhibition of orthotopic liver cancer growth in mice. The mouse weight in this animal experiment refers to the net weight of the mouse excluding the tumor.

[0081] In this animal experiment, the compound extracts for treating liver cancer cachexia were selected from Comparative Example 1, Example 2, and Comparative Example 2, and were respectively denoted as Formula 1-3.

[0082] The animal research protocol was conducted with permission from the Animal Committee of the University of Hong Kong. The orthotopic transplantation animal model used was the nude mouse (BALB / cAnA-nude). The nude mice were randomly divided into a normal group (Normal & Control), a model group, a compound extract group (Formulas 1-3), and a megestrol acetate (positive control) group (MA group). Mice in the normal group were bred normally without any additional treatment. The model group, compound extract group, and megestrol acetate group underwent modeling under the same conditions, i.e., primary liver cancer transplantation. The specific steps were as follows: First, luciferase-labeled MHCC-97L cells were transplanted subcutaneously into mice. After the tumors grew and developed subcutaneously, they were cut and placed in PBS buffer. The tumors were then cut into multiple 1mm×1mm×1mm pieces, ready for implantation into nude mice in the model group and the compound extract group. Before surgery, mice were anesthetized with a mixture of ketamine / toluidine (100mg and 10mg / kg). The nude mice were then opened abdominally, and the 1mm×1mm×1mm tumor pieces were transplanted into the left lobe of the liver and sutured. Two weeks later, in situ hepatocellular carcinoma was clearly observed in the nude mice, along with emaciation, reduced muscle mass and fat, weight loss, and a transition to cachexia. The model group received no medication. Mice in the compound extract group received a fixed dose of the compound extract (1g / kg body weight) weekly, while mice in the medroxyprogesterone acetate group received a fixed dose of medroxyprogesterone acetate (1g / kg body weight) weekly. This was continued for four weeks, as shown in the attached diagram (weeks 1-4). The tumor size and weight changes of mice in each group were recorded every week using a luciferase imaging analysis system (IVIS).

[0083] At the end of the experiment, all mice were euthanized by injecting an overdose of pentobarbital (200 mg / kg). Paraffin-embedded sections (5 μm) were collected using glass slides, dewaxed in xylene, and rehydrated with a gradient of ethanol from 100% to 70% (10% per 10% v / v). After rehydration, the slides were incubated with hematoxylin for 5 minutes, followed by incubation in 100 ml of 0.25% wt eosin for 1 minute (Sigma Aldrich, USA). Subsequently, the slides were immersed in Canada balsam (Sigma Aldrich, USA), and the morphology of H&E-stained hepatocellular carcinoma tissue was observed under a BX43 optical microscope (Olympus, Japan).

[0084] Experimental results are as follows Figures 1 to 13 As shown.

[0085] Figure 1 This diagram illustrates the tumor growth status of mice in each group after intervention. The liver tumors in the Model group were significantly larger than those in the compound extract groups (Formulas 1-3). Within the Formula groups, the tumors in Formula 2 mice were closest to those in the MA group, indicating that the compound extract in Formula 2 effectively inhibited tumor growth.

[0086] Figure 2 This is a schematic diagram of tumors at the treatment endpoint in mice. The Model group showed the most significant tumor growth, while the Formula 1-3 groups showed tumor reduction. The Formula 2 group showed a more significant reduction in tumor size compared to Formula 1 and Formula 3, indicating that the compound extract in Formula 2 can more effectively slow tumor growth.

[0087] Figure 3 This diagram illustrates the changes in fat content in mice during the experiment. Except for the normal control group, the fat content of mice in the other groups decreased due to the continuous growth of the tumor. The decrease in fat content in the Model group was significantly greater than that in Formula 1-3. Formula 2 showed the smallest decrease and exhibited a clear upward curve in weeks 1-2, indicating that Formula 2 effectively slowed the decline in fat content and provided nutritional supplementation.

[0088] Figure 4 This diagram illustrates the changes in receptor weight (including mouse body weight and tumor weight) in mice during the experiment. As mice aged, both body weight and tumor weight increased; 3-week-old mice are equivalent to 1-year-old humans, experiencing rapid weight gain. Therefore, the weight changes shown in the diagram are significant between weeks 3 and 4. Since receptor weight includes both mouse body weight and tumor weight, the situation in the Model group, where weight loss was offset by tumor growth, is similar to that in the Formula group, making it difficult to draw definitive conclusions. However... Figure 5 The results are more pronounced in the mouse body weight (net weight, excluding tumor weight) shown.

[0089] Figure 5 This diagram illustrates the changes in mouse body weight during the experiment. The final body weight of the Formula 2 group was closest to that of the normal group and slightly higher than that of the MA group, indicating that Formula 2 improved nutrition and increased body weight.

[0090] Figure 6 This diagram illustrates the changes in luciferase signal intensity in mice during the experiment. The signal intensity variation range in the Model group was significantly higher than that in the Formula and MA groups, a statistically significant result. Among the Formula groups, Formula 2 showed the lowest value, closest to the MA group, indicating that Formula 2 was more effective.

[0091] Figure 7 This is a schematic diagram of the final tumor size in mice. Compared to the model group, *p<0.05, **p<0.01. It is clearly observed that the tumors in the Model group were larger than those in the other four groups. The final tumors in the Formula 2 group were the smallest and significantly smaller than those in the other four groups. This indicates that Formula 2 has a more significant advantage in inhibiting tumor growth and improving cachexia, and all results are statistically significant.

[0092] Figure 8 This diagram illustrates the ratio of mouse body weight to tumor weight. Compared to the model group, *p<0.05, **p<0.01, ***p<0.001, and ns indicate no statistical significance. It was observed that the ratio in the Formula 2 group was similar to that in the MA group, only lower than the normal group. This may be attributed to Formula 2's effect of increasing mouse body weight and inhibiting tumor size. Furthermore, the Formula 2 group mice showed significantly higher weight than the Model group, a statistically significant result.

[0093] Figure 9-12 These are schematic diagrams of pathological sections of white fat, brown fat, thigh, and gastrocnemius muscle from a mouse. Figure 9 and 10 It can be seen that the white and brown adipose tissues of Formula 2 mice increased, from... Figure 11 and 12 It can be seen that the thigh and gastrocnemius muscles of mice in Formula 2 increased, indicating that Formula 2 has the effects of increasing nutrition, increasing fat and increasing muscle.

[0094] Figure 13 This is a schematic diagram showing the H&E staining results of liver cancer tissues from each group of mice. Figure 13 It can be seen that formulation 2 has the best therapeutic effect and is closest to the normal group.

[0095] In summary, mice in the compound extract group had a larger body weight, smaller tumor size (especially in group 2), and higher muscle fat content compared to the model group. Group 2 showed a greater advantage in inhibiting tumor growth than groups 1 and 3. Therefore, the compound extract of this invention has a good effect on increasing muscle fat content and improving nutrition, and has a significant therapeutic effect on treating liver cancer cachexia in mice. Simultaneously, this compound extract also inhibits the growth of liver tumors and has a certain effect on slowing tumor enlargement.

[0096] The above descriptions are merely several exemplary embodiments of the present invention and are not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any equivalent or related embodiments obtained by those skilled in the art through some modifications or variations made to the above-disclosed technical content without departing from the scope of the present invention are within the scope of the present invention.

Claims

1. A pharmaceutical composition for the prevention and / or treatment of liver cancer and its cachexia, comprising, by weight, the following components: 1-10 parts of yam, 1-10 parts of Ophiopogon japonicus, 2-20 parts of ginseng, 1-10 parts of coix seed, and 1.5-15 parts of dried tangerine peel.

2. A food composition for improving cachexia in liver cancer, comprising, by weight, the following components: 1-10 parts of yam, 1-10 parts of Ophiopogon japonicus, 2-20 parts of ginseng, 1-10 parts of coix seed, and 1.5-15 parts of dried tangerine peel.

3. The composition according to claim 1 or 2, wherein, The composition comprises 5-10 parts by weight of yam, preferably 10 parts; Preferably, the composition contains 5-10 parts by weight of Ophiopogon japonicus, more preferably 10 parts; Preferably, the composition contains 10-20 parts of ginseng, more preferably 20 parts, by weight. Preferably, the composition comprises 5-10 parts by weight of Job's tears, more preferably 10 parts; Preferably, the composition contains 8-15 parts by weight of dried tangerine peel, more preferably 15 parts.

4. The composition according to any one of claims 1-3, wherein, The weight ratio of yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel in the composition is 2: 2: 4: 2: (3-4).

5. A pharmaceutical extract for the prevention and / or treatment of liver cancer and its cachexia, prepared from a pharmaceutical composition according to claim 1, 3 or 4.

6. A food extract for improving liver cancer cachexia, prepared from the food composition according to claim 2, 3 or 4.

7. A method for preparing a pharmaceutical extract according to claim 5 or a food extract according to claim 6, comprising: (a) Mix yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel and extract with solvent, then concentrate and dry the obtained extract in sequence; or (b) Extract yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel separately with solvent, then concentrate and dry the extracts obtained separately, and then mix them.

8. The method according to claim 7, wherein, In (a) or (b), the solvent is an aqueous solution of water and / or ethanol; preferably, the volume fraction of the aqueous ethanol solution is 50-100%. Preferably, in (a) or (b), the weight ratio of the extract to the solvent is 1:5-25, more preferably 1:5-10; Preferably, in (a) or (b), the extraction is selected from one or more of decoction extraction, maceration extraction and ultrasonic extraction; More preferably, the decoction extraction is carried out under the following conditions: extraction temperature is 90-100℃; extraction is performed 1-5 times; and each extraction takes 2-4 hours. More preferably, the extraction process includes soaking and heating extraction in sequence; more preferably, the soaking time is 12-24 hours; even more preferably, the heating extraction is carried out under the following conditions: extraction temperature is 90-100℃; the number of extractions is 1-5; and the extraction time for each extraction is 0.5-2 hours. More preferably, the ultrasonic extraction is performed under the following conditions: ultrasonic frequency of 30-80 Hz; extraction temperature of 30-40℃; extraction times of 1-5 times; and extraction time of 1-4 hours per extraction. Preferably, in step (a) or (b), the yam, ophiopogon japonicus, ginseng, coix seed and tangerine peel are pulverized and sieved respectively before extraction; more preferably, the sieve mesh number is 50-200 mesh, preferably 100 mesh.

9. A traditional Chinese medicine preparation for the prevention and / or treatment of liver cancer and its cachexia, comprising the pharmaceutical composition according to claim 1, 3 or 4 or the pharmaceutical extract according to claim 5, and optionally pharmaceutically acceptable excipients; Preferably, the pharmaceutically acceptable excipient is selected from one or more of solvents, disintegrants, flavoring agents, preservatives, and colorants; Preferably, the dosage form of the traditional Chinese medicine preparation is an oral preparation or an injectable preparation; more preferably, the oral preparation is selected from one or more of tablets, capsules, pills, granules, suspensions, drop pills and oral liquid preparations.

10. A food for improving liver cancer cachexia, comprising a food composition according to claim 2, 3 or 4 or a food extract according to claim 6, and optionally food-acceptable excipients; Preferably, the food-acceptable excipients are selected from one or more of solvents, disintegrants, flavoring agents, preservatives, and colorants.

11. Use of the pharmaceutical composition according to claim 1, 3 or 4, the pharmaceutical extract according to claim 5 or the traditional Chinese medicine preparation according to claim 9 in the preparation of a medicament for the prevention and / or treatment of liver cancer and its cachexia.

12. Use of the food composition according to claim 2, 3 or 4, the food extract according to claim 6 or the food according to claim 10 in the preparation of a product for improving liver cancer cachexia; Preferably, the symptoms of liver cancer cachexia are selected from one or more reductions in muscle, fat, and body weight.

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