Traditional Chinese medicine composition with auxiliary function on colorectal cancer immunotherapy and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of biological medicine and food, and particularly discloses a traditional Chinese medicine composition with an auxiliary function on colorectal cancer immunotherapy and application of the traditional Chinese medicine composition, and the composition is prepared from the following components in parts by weight: 1-4 parts of turmeric extract, 1-2 parts of poria cocos extract and 1-2 parts of ginseng extract. The composition prepared by compounding and matching the turmeric extract, the ginseng extract and the poria cocos extract can induce activation of anti-tumor immune response in colorectal cancer tumors in a mouse tumor-bearing model, reverse an immunosuppressive microenvironment and promote response and efficacy exertion of an ICB therapy. Animal model tests prove that the composition has a remarkable synergistic effect on colorectal cancer immunotherapy; the composition disclosed by the invention is mild and stable in property, and can be effectively applied to preparation of medicinal and edible products.

Description

Technical Field

[0001] The present invention belongs to the technical field of biological medicines and foods, and relates to the development of a medicine or food for auxiliary immunotherapy, and specifically to a Chinese medicine composition with auxiliary function for immunotherapy of colorectal cancer and its application. Background Art

[0002] Colorectal cancer (CRC) is a common malignant tumor of the digestive system in clinical practice. Its incidence rate varies greatly in different regions of the world, with the highest rate in North America and Oceania, Europe in the middle, and lower rates in Asia and Africa. In southern my country, especially in the southeastern coastal areas, the incidence rate is significantly higher than in the north. In the past two decades, the incidence rate of colorectal cancer has been on the rise in most countries in the world. The China Cancer Statistics Report shows that the incidence and mortality rates of colorectal cancer in my country have maintained an upward trend, with cities much higher than rural areas, and the incidence rate of colon cancer in cities has increased significantly. More than 80% of patients are already in the middle and late stages when diagnosed, and more than 40% of patients have liver and lung metastases when discovered.

[0003] Immune checkpoint blockade (ICB) is an emerging immunotherapy that has achieved certain results in tumor treatment. Its principle is based on the activation mechanism of cytotoxic T lymphocytes (CTLs). At present, ICB therapy has become an important cancer treatment method after surgery, chemoradiotherapy and targeted therapy. For colorectal cancer, ICB therapy has become one of the important treatment methods currently used. However, ICB therapy is only effective for a small number of colorectal cancer patients with tumor microsatellite instability (MSI-high) and the response speed is generally slow. How to improve the response speed and anti-tumor ability of ICB therapy to improve the patient's survival cycle and survival rate is an important issue that needs to be urgently solved in the current clinical treatment of colorectal cancer. Studies have found that the heterogeneity of the tumor microenvironment and its mediated immunosuppression are one of the key factors affecting the effect of immunotherapy for colorectal cancer. The tumor microenvironment is composed of tumor cells, endothelial cells, immune cells, fibroblasts, signaling molecules and extracellular matrix. Similar to other solid tumors, colorectal tumors generally have an immunosuppressive microenvironment with high levels of immunosuppressive cells and low levels of effector immune cells, most of which are functionally failed. This can seriously hinder the response and efficacy of ICB therapy and lead to the occurrence of drug resistance. Summary of the invention

[0004] In view of the deficiencies in the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition with auxiliary function for immunotherapy of colorectal cancer. The traditional Chinese medicine composition of the present invention comprises turmeric extract, ginseng extract and Poria extract. The three components can activate anti-tumor immune response and reverse immunosuppressive microenvironment inside the tumor through synergistic action, which is beneficial to the response and efficacy of ICB therapy and realizes a significant synergistic effect on immunotherapy of rectal cancer.

[0005] The present invention is achieved through the following technical solutions:

[0006] A traditional Chinese medicine composition with auxiliary function for immunotherapy of colorectal cancer is composed of the following components in parts by weight: 1 to 4 parts of turmeric extract, 1 to 2 parts of Poria extract, and 1 to 2 parts of ginseng extract.

[0007] Preferably, the Chinese medicine composition having auxiliary function for immunotherapy of colorectal cancer is composed of the following components in parts by weight: 4 parts of turmeric extract, 1 part of Poria extract, and 1 part of ginseng extract.

[0008] A further improvement of the present invention is:

[0009] The turmeric extract is a product obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the rhizome of the ginger plant turmeric.

[0010] Furthermore, the Poria cocos extract is a product obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the sclerotium of the Polyporaceae fungus.

[0011] Furthermore, the ginseng extract is a product obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the root of ginseng of the Araliaceae family.

[0012] A further improvement of the present invention is:

[0013] The use of the above-mentioned Chinese medicine composition in the preparation of a drug having auxiliary function in immunotherapy of colorectal cancer.

[0014] Furthermore, the medicine also includes pharmaceutically acceptable excipients, and the dosage form of the medicine includes injection, tablet, powder, capsule, oral liquid or granule.

[0015] A further improvement of the present invention is:

[0016] The use of the above-mentioned Chinese medicine composition in the preparation of functional food or health care product with auxiliary function in immunotherapy of colorectal cancer.

[0017] Furthermore, the functional food also includes formula excipients acceptable for functional foods, and the dosage form of the functional food is soft capsules, hard capsules, oral liquids, granules or tablets; the health care products also include formula excipients acceptable for health care products, and the dosage form of the health care products is soft capsules, hard capsules, oral liquids, granules or tablets.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] The present invention provides a traditional Chinese medicine composition with auxiliary function for immunotherapy of colorectal cancer. The product combines three components, namely, turmeric extract, ginseng extract and Poria cocos extract, and has a significant synergistic effect in immunotherapy of colorectal cancer. The efficacy of the product is confirmed by animal model experiments. The composition of the present invention is mild and stable in nature and can be effectively used in the preparation of products for both medicinal and edible purposes.

[0020] The composition prepared by compounding three components of turmeric extract, ginseng extract and Poria cocos extract can induce anti-tumor immune response and reverse immunosuppressive microenvironment inside colorectal cancer tumors in mouse tumor-bearing models, thereby promoting the response and efficacy of ICB therapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a comparison chart of the proportions of different types of immune cells in the tumor tissues of tumor-bearing mice in each group;

[0022] Among them, (a) white blood cell ratio (CD45 + ); (b) T cell ratio (CD3 + ); (c) the proportion of cytotoxic T cells (CD8 + ); (d) helper T cell ratio (CD4 + ); (e) proportion of regulatory T cells (Foxp3 + CD4 + ). Note: Comparison of experimental group 1 with blank control group; comparison of experimental group 1 with comparison groups 1 and 2; comparison of experimental group 1 with experimental groups 2 and 3, *P<0.05, **P<0.01, ***P<0.001.

[0023] Figure 2 This is a diagram showing the synergistic effect of the composition of the present invention on tumor immunotherapy;

[0024] Among them, (a) changes in tumor mass in the blank control group and three experimental groups after 24 days of different treatments (Note: comparing experimental group 3 with the blank control group, *P<0.05, **P<0.01, ***P<0.001; comparing experimental group 3 with experimental groups 1 and 2 at the same time, #P<0.05, ##P<0.01, ###P<0.001); (b) tumor inhibition rate (tumor inhibition rate) of tumor-bearing mice in the three experimental groups.

[0025] Figure 3 The graph shows the survival time of tumor-bearing mice in each group. DETAILED DESCRIPTION

[0026] The present invention is described in detail below in conjunction with specific embodiments.

[0027] The turmeric extract used in the embodiment of the present invention is prepared by the following steps:

[0028] The product is prepared by sequentially washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the rhizome of turmeric.

[0029] The ginseng extract used in the embodiment of the present invention is prepared by the following steps:

[0030] The product is obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the root of ginseng.

[0031] The Poria cocos extract used in the embodiment of the present invention is prepared by the following steps:

[0032] The product is obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the sclerotium of Poria cocos.

[0033] Example 1

[0034] This embodiment provides a traditional Chinese medicine composition having an auxiliary function in immunotherapy of colorectal cancer, the composition comprising the following components in parts by weight: 4 parts of turmeric extract, 1 part of ginseng extract and 1 part of Poria extract.

[0035] Example 2

[0036] This embodiment provides a traditional Chinese medicine composition having an auxiliary function in immunotherapy of colorectal cancer, the composition comprising the following components in parts by weight: 2 parts of turmeric extract, 2 parts of ginseng extract and 2 parts of Poria extract.

[0037] Example 3

[0038] This embodiment provides a traditional Chinese medicine composition having an auxiliary function in immunotherapy of colorectal cancer, the composition comprising the following components in parts by weight: 1 part of turmeric extract, 2 parts of ginseng extract and 2 parts of Poria extract.

[0039] Comparative Example 1

[0040] In this comparative example, only 4 portions of turmeric extract were taken, and no ginseng extract or Poria extract was added.

[0041] Comparative Example 2

[0042] In this comparative example, 2 parts of ginseng extract and 2 parts of Poria cocos extract were taken, and no turmeric extract was added.

[0043] Verification Example 1

[0044] In order to verify the safety of the composition of the present invention as a medicine, functional food and health product, animal toxicity experiments were conducted on the products obtained in Examples 1 to 3, as follows:

[0045] 1. Experimental Animals

[0046] Wistar rats, SPF grade, male, 171-212 g, were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd.

[0047] 2. Experimental Plan

[0048] (1) Dosage regimen: Rats were randomly divided into 6 groups (15 rats in each group), including a blank control group, experimental groups 1 to 3, and comparative groups 1 and 2. The experimental groups 1 to 3 and comparative groups 1 and 2 were gavaged with 0.1 g / kg.bw of the test composition; the test composition used in the experimental groups 1 to 3 was the product obtained in Examples 1 to 3; the test composition used in the comparative groups 1 and 2 was the product obtained in Comparative Examples 1 and 2. The frequency of administration was once a day for 5 consecutive weeks. The blank control group was given the same volume of purified water.

[0049] (2) Preparation of oral preparations: For the test composition or single extract in each example or comparative example, 2 parts by weight of the test composition or single extract and 5 parts by weight of high-purity lecithin were added to a rotary evaporator, anhydrous ethanol was added to the evaporator, and the resulting mixture was heated at 60° C. for 20 minutes, then the ethanol was removed by reduced pressure distillation and vacuum dried. Finally, deionized water was added to the rotary evaporator and hydrated at 60° C. for 20 minutes, and then ultrasonically dispersed and homogenized at high speed to obtain an oral dosage form containing the composition.

[0050] (3) Data collection: The general condition of the rats was observed and recorded once a day. The rats were weighed once a week, and the measurement results are shown in Table 1. After the start of drug administration, the blood routine indicators of the rats in each group were measured at the end of the 1st, 3rd and 5th week of drug administration. The test items included white blood cell count (WBC), hemoglobin content (HGB), red blood cell count (RBC), platelet count (PLT), and monocyte count (Mono). The measurement results are shown in Table 2. After the start of drug administration, the blood biochemical indicators of the rats in each group were measured at the end of the 1st, 3rd and 5th week of drug administration. The test items included serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), serum urea (UREA) and creatinine (CREA) levels. The measurement results are shown in Table 3.

[0051] Table 1.

[0052] Group Before giving Week 1 Week 2 Week 3 Week 4 Week 5 Blank control group 192.21±13.42 247.57±20.33 323.69±24.51 382.57±35.88 443.83±37.21 491.32±36.9 Experimental Group 1 189.39±10.94 248.72±19.94 332.64±29.12 379.84±31.07 438.72±32.55 485.24±30.77 Experimental Group 2 190.16±11.66 250.32±21.74 326.41±25.92 369.41±29.88 425.94±32.77 475.21±34.56 Experimental Group 3 191.67±10.33 251.19±23.12 319.88±25.21 372.51±28.33 427.81±30.1 477.94±30.1 Comparison Group 1 188.93±9.89 246.97±19.57 336.74±29.76 383.54±30.21 432.81±29.46 482.65±32.24 Comparison Group 2 191.08±10.12 248.67±20.91 328.86±26.77 378.57±28.93 429.93±29.66 479.12±33.21

[0053] Note: Comparison between blank control group and experimental group, between experimental group and comparison group, and between experimental groups, *P<0.05, **P<0.01, ***P<0.001;

[0054] Table 2.

[0055]

[0056] Note: WBC reference range: 7.93-17.98 (10 9 / L); RBC reference range: 6.39-8.21 (10 12 / L); HGB reference range: 139-175 (g / L); PLT reference range: 933-1788 (10 9 / L); Mono reference range: 0.65-1.54 (10 9 / L). The above-mentioned reference ranges are derived from the data tested and released by Weitong Lihua.

[0057] Table 3.

[0058]

[0059]

[0060] Note: ALT reference range: 40.4-86.8 (U / L); AST reference range: 99.3-259.2 (U / L); ALP reference range: 174.4-523.8 (U / L); UREA reference range: 5.30-10.37 (mmol / L); CREA reference range: 24.2-39.6 (μmol / L). The above index reference ranges are derived from the data tested and released by Weitong Lihua.

[0061] Table 1 shows the weight growth trend of rats in each treatment group over time. The results show that there is no significant difference in weight growth between the experimental group and the blank control group; there is no significant difference in weight growth between the experimental group and the comparison group. There is no significant difference in weight growth between the experimental groups.

[0062] Table 2 shows the blood routine index measurement results of rats in each treatment group at the 1st, 3rd and 5th week. The blood routine index measurement results of rats in each group were within the reference range, and no abnormal individuals were found.

[0063] Table 3 shows the blood biochemical index measurement results of rats in each treatment group at the 1st, 3rd and 5th week. The blood biochemical index measurement results of rats in each group were within the reference range, and no abnormal individuals were found.

[0064] Verification Example 2

[0065] In order to verify that the composition of the present invention has the effect of regulating the tumor immune microenvironment, the products obtained in Examples 1 to 3 were subjected to functional verification, as follows:

[0066] 1. Experimental Animals

[0067] BALB / c mice, SPF grade, male, 19-22 g were selected.

[0068] 2. Experimental Plan

[0069] (1) Establishment of tumor model

[0070] ①Cell line selection: Use CT26 mouse colorectal cancer cell line and culture it normally.

[0071] ② Tumor inoculation: BALB / c male mice were selected as model animals. After the mice were anesthetized, the abdomen was surgically incised to expose the cecum. The needle was inserted into the cecum body along the cecum axis to the cecal mesentery triangle, and the colon cancer cell suspension was slowly injected (20 μL per mouse, containing 2×10 5 After the needle was withdrawn, the injection site was gently pressed to confirm that there was no fluid leakage. The mouse peritoneum and abdominal wall muscle layer were sutured, and finally the skin was sutured. After 20 days of feeding, relevant experiments were performed after palpable nodules appeared in the mouse abdomen.

[0072] (2) Preparation of oral preparations: For the test composition or single extract in each example or comparative example, 2 parts by weight of the test composition or single extract and 5 parts by weight of high-purity lecithin were added to a rotary evaporator, anhydrous ethanol was added to the evaporator, and the resulting mixture was heated at 60° C. for 20 minutes, then the ethanol was removed by reduced pressure distillation and vacuum dried. Finally, deionized water was added to the rotary evaporator and hydrated at 60° C. for 20 minutes, and then ultrasonically dispersed and homogenized at high speed to obtain an oral dosage form containing the composition.

[0073] (3) Experimental treatment: Tumor-bearing mice were randomly divided into 6 groups (20 mice in each group), including a blank control group, experimental groups 1 to 3, and comparison groups 1 and 2. Experimental groups 1 to 3 and comparison groups 1 and 2 were gavaged with 0.1 g / kg.bw of the test composition; the test composition used in experimental groups 1 to 3 was the product obtained in Examples 1 to 3; the test composition used in comparison groups 1 and 2 was the product obtained in Comparative Examples 1 and 2. The frequency of administration was 1 time / 2 days for 4 consecutive times. The blank control group was given the same volume of purified water. 12 hours after the 4th administration, the mouse tumor tissue was peeled off for immune cell detection.

[0074] (4) Immune cell flow cytometry detection: separate the tumor tissue, cut the tumor tissue into pieces with scissors (operate on ice), add digestion solution to the pieces of tumor tissue, and digest at 37°C. After digestion is terminated, the tumor tissue suspension is aspirated and filtered through a cell filter, centrifuged, and the supernatant is removed before dispersion. Finally, after blocking, antibody incubation, and washing, the sample is analyzed on the flow cytometer. The detection items are: white blood cell ratio (CD45 + ), T cell ratio (CD3 + ), cytotoxic T cell ratio (CD8 + ), helper T cell ratio (CD4 + ) and regulatory T cell ratio (Foxp3 + CD4 + ), test results Figure 1 shown.

[0075] The comparison results showed that the level of leukocytes (CD45 + ) increased the most, significantly higher than the blank control group, experimental groups 2, 3 and comparison groups 1, 2; the level of T cells in the tumor tissue of mice in experimental group 1 (CD3 + ) increased the most, significantly higher than the blank control group, experimental groups 2, 3 and comparison groups 1, 2; the level of cytotoxic T cells in the tumor tissue of mice in experimental group 1 (CD8 + ) increased the most, significantly higher than the blank control group, experimental groups 2, 3 and comparison groups 1, 2; the level of helper T cells in the tumor tissue of mice in experimental group 1 (CD4 + ) increased the most, significantly higher than the blank control group, experimental groups 2, 3 and comparison groups 1, 2; the proportion of regulatory T cells in tumor tissues of mice in experimental group 1 (Foxp3 + CD4 + ) decreased the least, which was significantly lower than that in the blank control group, experimental groups 2, 3 and comparison groups 1, 2. The above results show that the immune microenvironment of tumor tissue of mice in experimental group 1 was the best.

[0076] Verification Example 3

[0077] In Verification Example 2, the test composition of Example 1 (the mass ratio of turmeric extract, ginseng extract and Poria extract is 4:1:1) showed the best tumor immune microenvironment regulation effect. In order to verify that the test composition of Example 1 has a tumor immunotherapy synergistic effect, functional verification was carried out, as follows:

[0078] 1. Experimental Animals

[0079] BALB / c mice, SPF grade, male, 19-22 g were selected.

[0080] 2. Experimental Plan

[0081] (1) Establishment of tumor model

[0082] ①Cell line selection: The CT26 mouse colorectal cancer cell line was used in the study and cultured normally.

[0083] ② Tumor inoculation: BALB / c male mice were selected as model animals. After the mice were anesthetized, the abdomen was surgically incised to expose the cecum. The needle was inserted into the cecum body along the cecum axis to the cecal mesentery triangle, and the colon cancer cell suspension was slowly injected (20 μL per mouse, containing 2×10 5 After the needle was withdrawn, the injection site was gently pressed to confirm that there was no fluid leakage. The mouse peritoneum and abdominal wall muscle layer were sutured, and finally the skin was sutured. After 20 days of feeding, relevant experiments were performed after palpable nodules appeared in the mouse abdomen.

[0084] (2) Preparation of oral preparation: 4 parts by weight of turmeric extract, 1 part by weight of ginseng extract, 1 part by weight of Poria cocos extract and 15 parts by weight of high-purity lecithin were added to a rotary evaporator, anhydrous ethanol was added to the evaporator, and the resulting mixture was heated at 60°C for 20 minutes, then the ethanol was removed by reduced pressure distillation and vacuum dried. Finally, deionized water was added to the rotary evaporator and hydrated at 60°C for 20 minutes, then ultrasonically dispersed and homogenized at high speed to obtain an oral dosage form containing the composition.

[0085] (3) Experimental treatment 1: The tumor-bearing mice were randomly divided into 4 groups (20 mice in each group), including a blank control group, experimental group 1 (intraperitoneal injection of 0.01g / kg.bw PD-1 antibody), experimental group 2 (mice were gavaged with 0.1g / kg.bw of the test composition of Example 1) and experimental group 3 (mice were gavaged with 0.1g / kg.bw of the test composition of Example 1 and simultaneously intraperitoneally injected with 0.01g / kg.bw PD-1 antibody). The test composition of Example 1 was administered once every 2 days; the PD-1 antibody was administered once every 3 days for 24 consecutive days. The blank control group was given the same volume of purified water. After 24 days, the mouse tumors were peeled off and weighed, and the tumor inhibition rate (tumor inhibition rate) was calculated. The calculation formula is as follows: Tumor growth inhibition rate = (1-average tumor weight of the treatment group / average tumor weight of the control group) × 100%. The obtained values ​​were compared among the groups. For specific results, see Figure 2 .

[0086] The results showed that compared with the blank control group, experimental group 1 and experimental group 2, the tumor mass of mice in experimental group 3 decreased the least, and compared with experimental group 1 and experimental group 2, the tumor inhibition rate of experimental group 3 was the highest. Therefore, experimental group 3 showed a more significant tumor inhibition effect.

[0087] (3) Experimental treatment 2: The tumor-bearing mice were randomly divided into 4 groups (20 mice in each group), including a blank control group, experimental group 1 (intraperitoneal injection of 0.01 g / kg.bw PD-1 antibody), experimental group 2 (mice were gavaged with 0.1 g / kg.bw of the test composition of Example 1) and experimental group 3 (mice were gavaged with 0.1 g / kg.bw of the test composition of Example 1 and intraperitoneally injected with 0.01 g / kg.bw PD-1 antibody at the same time). The test composition of Example 1 was administered once every 2 days; the PD-1 antibody was administered once every 3 days for 60 consecutive days. The blank control group was administered with the same volume of purified water. Within 60 days, the death data of mice in each group were recorded and a survival curve was drawn. The results are shown in the table below. Figure 3 .

[0088] The results showed that compared with the blank control group, experimental group 1 and experimental group 2, the survival time of mice in experimental group 3 was significantly prolonged.

[0089] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent transformation or modification made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition having an auxiliary function in immunotherapy of colorectal cancer, characterized in that: The invention is composed of the following components in parts by weight: 1 to 4 parts of turmeric extract, 1 to 2 parts of tuckahoe extract and 1 to 2 parts of ginseng extract.

2. A Chinese medicine composition having an auxiliary function for immunotherapy of colorectal cancer according to claim 1, characterized in that: The invention is composed of the following components in parts by weight: 4 parts of turmeric extract, 1 part of Poria cocos extract and 1 part of ginseng extract.

3. A Chinese medicine composition having an auxiliary function for immunotherapy of colorectal cancer according to claim 1 or 2, characterized in that: The turmeric extract is a product obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the rhizome of the ginger plant turmeric.

4. A Chinese medicine composition having an auxiliary function for immunotherapy of colorectal cancer according to claim 1 or 2, characterized in that: The Poria cocos extract is a product obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the sclerotium of the Polyporaceae fungus.

5. A Chinese medicine composition having an auxiliary function for immunotherapy of colorectal cancer according to claim 1 or 2, characterized in that: The ginseng extract is a product obtained by washing, vacuum drying, crushing, ethanol extraction, solid-liquid separation, reduced pressure concentration and vacuum drying the root of ginseng of the Araliaceae family.

6. Use of the Chinese medicine composition as claimed in claim 1 or 2 in the preparation of a drug having an auxiliary function in immunotherapy of colorectal cancer.

7. Use of the Chinese medicine composition according to claim 6 in the preparation of a drug having an auxiliary function in immunotherapy of colorectal cancer, characterized in that: The medicine also includes pharmaceutically acceptable formula excipients, and the dosage form of the medicine includes injection, tablet, powder, capsule, oral liquid or granule.

8. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of functional foods or health products having auxiliary functions in immunotherapy of colorectal cancer.

9. Use of the Chinese medicine composition according to claim 8 in the preparation of functional food or health care product having auxiliary function in immunotherapy of colorectal cancer, characterized in that: The functional food also includes formula excipients acceptable for functional foods, and the dosage form of the functional food is soft capsules, hard capsules, oral liquids, granules or tablets; the health care products also include formula excipients acceptable for health care products, and the dosage form of the health care products is soft capsules, hard capsules, oral liquids, granules or tablets.

Images