Traditional Chinese medicine composition for treating colorectal tumor by regulating immune function and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating colorectal tumor by regulating immune function. The invention further provides a traditional Chinese medicine extract and a preparation method thereof. The invention further provides a traditional Chinese medicine preparation. The invention further provides application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the traditional Chinese medicine preparation in preparation of medicines for treating colorectal tumor. According to the traditional Chinese medicine composition for treating the colorectal tumor by adjusting the immune function and the preparation method thereof, the prepared traditional Chinese medicine composition has the effects of supporting body resistance, invigorating spleen and tonifying kidney, clearing away heat and toxic materials, activating blood and removing stasis, tonifying qi and reinforcing vital essence, and removing stasis and food retention, and can be used for improving the immunosuppression microenvironment of the colorectal tumor in cooperation with chemotherapy drugs; the anti-tumor immune function of a colorectal tumor patient is improved, the tumor development is inhibited, and a new thought is provided for the immunotherapy of the colorectal tumor.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and a preparation method thereof. Background Art

[0002] Colorectal cancer (CRC) is a common cancer globally, and screening, early diagnosis, and treatment of colorectal cancer are particularly important.

[0003] In recent years, with the emergence of targeted drugs and immune drugs, the quality of life and survival rate of colorectal cancer patients have been significantly improved. However, the low incidence of microsatellite instability-high (MSI-H) / deficient mismatch repair (dMMR) makes the benefits of chemotherapy and immune checkpoint inhibitors (ICIs) such as anti-PD-1 / PD-L1 / CTLA-4 less in clinical use. Most of this is attributed to the tumor immunosuppressive microenvironment. For example, it is difficult for tumor-suppressive cells (such as CD8 + T cells, NK cells, etc.) to infiltrate, and the increase of immunosuppressive cells (regulatory T cells, tumor-associated neutrophils, tumor-associated fibroblasts, etc.) and immunosuppressive molecules (such as IL-4, IL-10, CCL2, etc.) are the main difficulties in current immunotherapy.

[0004] Currently, traditional Chinese medicine has received great attention as an adjuvant therapy for tumor treatment. Traditional Chinese medicine can not only directly kill tumor cells, but also activate the body's immune system and improve the immunosuppressive microenvironment, thereby assisting chemotherapy or immunotherapy to improve efficacy, reduce toxicity, and alleviate adverse reactions, thus improving the compliance of patients with tumor treatment. From the perspective of traditional Chinese medicine, colorectal cancer belongs to the categories of "intestinal wind", "visceral toxin", "intestinal polyp", and "accumulation". The etiology and pathogenesis are mostly due to factors such as internal deficiency of the body and exogenous six pathogenic factors, which cause abnormal generation and distribution of qi, blood, and body fluids in the body, resulting in pathological products such as phlegm, stasis, and toxin, which accumulate in the body's viscera and combine with each other to form a mass over time. In the prior art, the research on traditional Chinese medicine compounds for treating tumors mainly focuses on functions such as improving drug cytotoxicity (CN118236463A) and reducing the side effects of radiotherapy and chemotherapy (CN118161579A), lacking research on improving the immunosuppressive microenvironment, enhancing tumor immunogenic death, and immune checkpoint exposure. Summary of the Invention

[0005] In view of the above-mentioned disadvantages of the prior art, the object of the present invention is to provide a traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and its preparation method, which has the characteristics of rigorous formula, scientific compatibility, can maximize the efficacy of the drug, and is convenient to prepare, has good patient compliance, and has no toxic and side effects. It can use traditional Chinese medicines for strengthening healthy qi and cultivating the root, clearing heat and detoxifying as immune regulators, and play the advantages of multi-channel, multi-target, and multi-link effects of traditional Chinese medicines to improve the anti-tumor immune function of colorectal tumor patients and inhibit the progression of tumors.

[0006] To achieve the above object and other related objects, the first aspect of the present invention provides a traditional Chinese medicine composition for treating colorectal tumors by regulating immune function. Calculated by weight, it includes the following raw material components:

[0007] 10 - 30 parts of Codonopsis pilosula;

[0008] 20 - 35 parts of Astragalus membranaceus;

[0009] 10 - 20 parts of Epimedium brevicornu;

[0010] 10 - 25 parts of raw Atractylodes macrocephala;

[0011] 20 - 35 parts of Coix lacryma-jobi;

[0012] 15 - 30 parts of Akebia trifoliata;

[0013] 15 - 30 parts of Sargentodoxa cuneata;

[0014] 20 - 30 parts of Smilax glabra.

[0015] The second aspect of the present invention provides a traditional Chinese medicine extract, which is prepared by using the traditional Chinese medicine composition described in the first aspect of the present invention as raw materials.

[0016] The third aspect of the present invention provides a preparation method of the above-mentioned traditional Chinese medicine extract, including: taking each raw material component of the traditional Chinese medicine composition described in the first aspect of the present invention according to the ratio, mixing them, filtering the obtained mixture after decocting with water, and concentrating and drying the obtained extract into powder to provide the above-mentioned traditional Chinese medicine extract.

[0017] The fourth aspect of the present invention provides a traditional Chinese medicine preparation, which includes a therapeutically effective amount of the traditional Chinese medicine composition provided in the first aspect of the present invention, or a therapeutically effective amount of the traditional Chinese medicine extract provided in the second aspect of the present invention, and one or more conventional pharmaceutically acceptable excipients.

[0018] The fifth aspect of the present invention provides the use of the traditional Chinese medicine composition provided in the first aspect of the present invention, the traditional Chinese medicine extract provided in the second aspect of the present invention, or the traditional Chinese medicine preparation provided in the fourth aspect of the present invention in the preparation of drugs for treating colorectal tumors.

[0019] As described above, a traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and its preparation method provided by the present invention have the following beneficial effects:

[0020] (1) The traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and its preparation method provided by the present invention have the effects of strengthening the healthy qi and cultivating the root, invigorating the spleen and kidney, clearing heat and detoxifying, promoting blood circulation to remove stasis, replenishing qi and cultivating yuan, dissipating binds and reducing accumulation, increasing the possibility for the clinical treatment of this intractable disease of colorectal tumors.

[0021] (2) The traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and its preparation method provided by the present invention have been confirmed by in vitro and in vivo tests to have a good tumor inhibitory effect, can regulate the body's immune function, reverse the immunosuppressive microenvironment, transform "cold tumors" into "hot tumors", and can improve the chemotherapy efficacy when combined with chemotherapy drugs.

[0022] (3) The present invention aims to provide a traditional Chinese medicine composition for treating colorectal tumors and its preparation method with a rigorous formula, scientific compatibility, which can maximize the efficacy of the drug, and is convenient to prepare, has good patient compliance, and has no toxic and side effects. Using traditional Chinese medicines for strengthening the healthy qi and cultivating the root, clearing heat and detoxifying as immune regulators, giving play to the advantages of the multi-channel, multi-target and multi-link effects of traditional Chinese medicines to improve the anti-tumor immune function of colorectal tumor patients and inhibit the progression of tumors.

[0023] (4) The traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and its preparation method provided by the present invention can synergistically improve the immunosuppressive microenvironment of colorectal tumors with chemotherapy drugs, increase the local infiltration of cytotoxic T lymphocytes, and increase the possibility of clinically applying immune checkpoint inhibitors, providing new ideas for the immunotherapy of colorectal tumors.

[0024] (5) The traditional Chinese medicine composition for treating colorectal tumors by regulating immune function and its preparation method provided by the present invention are economical and practical, have good patient compliance, have no obvious toxic and side effects, have broad clinical application prospects, and the preparation process is simple, rapid, efficient, easy to operate, convenient to carry and convenient to take. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It shows the effect diagram of the traditional Chinese medicine composition obtained in the present invention on the activity of human microsatellite stable (MSS) type colon cancer cell line SW480.

[0026] Figure 2Shown is the immunoblotting map of STAT1, STING, p-STING, IFNA-R1, and PD-L1 proteins of the tumor cells SW480 in vitro by the Chinese medicine composition obtained in the present invention.

[0027] Figure 3 Shown is the comparison chart of the growth of colorectal tumors in mice after treatment with the Chinese medicine composition obtained in the present invention and combined with capecitabine.

[0028] Figure 4 Shown is the comparison chart of the expression levels of Ki-67 and PD-L1 in the colorectal of mice after treatment with the Chinese medicine composition obtained in the present invention and combined with capecitabine.

[0029] Figure 5 Shown is the CD8 in the colorectal tumors of mice after treatment with the Chinese medicine composition obtained in the present invention and combined with capecitabine + , Granzyme B + comparison chart of the infiltration of T cells.

[0030] Figure 6 Shown is the comparison chart of the levels of cytokines IFN-β and IFN-γ in the sera of mice after treatment with the Chinese medicine composition obtained in the present invention and combined with capecitabine.

[0031] Figure 7 Shown is the comparison chart of the effects of the Chinese medicine composition obtained in the present invention and combined with capecitabine on the mRNA expression of chemokines CCL5 and CXCL10 in colorectal tumors of mice.

[0032] Figure 8 Shown is the immunoblotting map of STING, cGAS, p-STING, and PD-L1 proteins in the colorectal tumors of mice after treatment with the Chinese medicine composition obtained in the present invention and combined with capecitabine.

[0033] Figure 9 Shown is the diagram of the effects of the Chinese medicine composition obtained in the present invention and combined with capecitabine on the liver and kidney functions of mice. Detailed implementation manners

[0034] Before further describing the specific implementation manners of the present invention, it should be understood that the protection scope of the present invention is not limited to the following specific implementation manners; it should also be understood that the terms used in the embodiments of the present invention are for the purpose of describing specific implementation manners, rather than limiting the protection scope of the present invention. The test methods without specific conditions indicated in the following examples are generally carried out under conventional conditions or according to the conditions recommended by each manufacturer.

[0035] When numerical ranges are given in the embodiments, it should be understood that unless otherwise specified in the present invention, both endpoints of each numerical range and any value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the art of this technology. In addition to the specific methods, devices, and materials used in the embodiments, according to the knowledge of those skilled in the art of this technology and the description of the present invention, any methods, devices, and materials of the prior art similar to or equivalent to those described in the embodiments of the present invention can also be used to implement the present invention.

[0036] Unless otherwise specified, the experimental methods, detection methods, and preparation methods disclosed in the present invention all adopt the conventional techniques in the art of this technology.

[0037] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for treating colorectal tumors by regulating immune function, which includes the following raw material components by weight:

[0038] Codonopsis pilosula 10 - 30 parts; specifically, such as 10 - 13 parts, 13 - 17 parts, 17 - 23 parts, 23 - 30 parts;

[0039] Astragalus membranaceus 20 - 35 parts; specifically, such as 20 - 28 parts, 28 - 32 parts, 32 - 35 parts;

[0040] Epimedium brevicornu 10 - 20 parts; specifically, such as 10 - 13 parts, 13 - 17 parts, 17 - 20 parts;

[0041] Atractylodes macrocephala Koidz. 10 - 25 parts; specifically, such as 10 - 16 parts, 16 - 20 parts, 20 - 25 parts;

[0042] Coix lacryma - jobi L. 20 - 35 parts; specifically, such as 20 - 28 parts, 28 - 32 parts, 32 - 35 parts;

[0043] Akebia trifoliata (Thunb.) Koidz. 15 - 30 parts; specifically, such as 15 - 20 parts, 25 - 28 parts, 28 - 30 parts;

[0044] Sargentodoxa cuneata (Oliv.) Rehd. et Wils. 15 - 30 parts; specifically, such as 15 - 20 parts, 20 - 25 parts, 25 - 30 parts;

[0045] Smilax glabra Roxb. 20 - 30 parts: specifically, such as 20 - 25 parts, 25 - 28 parts, 28 - 30 parts.

[0046] In the present invention, the Codonopsis pilosula is the dried root of Codonopsis pilosula Franch., Codonopsis pilosula Nannf. or Codonopsis tangshen Oliv., and has the effects of invigorating the spleen and benefiting the lung, nourishing blood and promoting the production of body fluid.

[0047] In the present invention, the Astragalus membranaceus is the dried root of Astragalus membranaceus (Fisch.) Bunge var. mongholicus (Bunge) Hsiao or Astragalus membranaceus (Fisch.) Bunge, and has the effects of invigorating qi and lifting yang, securing the exterior and stopping sweating, promoting diuresis and alleviating edema, nourishing blood and promoting the production of body fluid, activating qi and dredging collaterals, expelling pus and toxin, and promoting granulation and wound healing.

[0048] In the present invention, the Herba Epimedii, also known as Epimedium, is the dried leaves of the Berberidaceae plants Epimedium, Epimedium sagittatum, Epimedium pubescens or Epimedium koreana, and has the effects of invigorating kidney yang, strengthening tendons and bones, and removing rheumatism.

[0049] In the present invention, the raw Atractylodes macrocephala is the dried rhizome of the Atractylodes macrocephala plant of the Asteraceae family, and has the effects of invigorating the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and stabilizing pregnancy.

[0050] In the present invention, the coix seed is the dried mature seed of the Gramineae plant Coix, which has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stopping diarrhea, removing arthralgia, discharging pus, and detoxifying and dispersing nodules.

[0051] In the present invention, the August twig is the dried mature fruit of Akebia, Akebia trifoliata and Akebia scabra, which has the effects of soothing the liver and regulating qi, promoting blood circulation, dispersing blood stasis and relieving pain, and relieving restlessness and promoting diuresis.

[0052] In the present invention, the red vine is the stem of the red vine of the woody vine plant of the Akebia family, which has the effects of clearing away heat and detoxifying, relieving swelling and dispersing blood stasis, and dispelling wind and killing insects.

[0053] In the present invention, the Chinese smilax glabra is the dried rhizome of the lily family plant Smilax glabra, which has the effects of detoxification, dehumidification and joint unblocking.

[0054] The above-mentioned raw materials (or medicinal materials) used in the present invention can be purchased from ordinary medical stores or Chinese medicinal material sales companies. Their specifications meet national medical standards or meet relevant regulations such as the Chinese Pharmacopoeia, and are all included in the catalog of medicinal and edible products stipulated by the former Ministry of Health.

[0055] The Chinese medicine composition for treating colorectal tumors by regulating immune function fully follows the principle of syndrome differentiation and treatment in traditional Chinese medicine, takes "strengthening the body's qi and treating cancer" as the principle, takes Astragalus, Codonopsis and Epimedium as the main medicines, which can both strengthen the spleen and replenish qi, and warm and nourish the kidney yang, taking into account both the acquired and acquired constitutions, and jointly nourishing the vital energy, takes Raw Atractylodes and Coix Seed as the assistant medicines for strengthening the spleen and drying dampness, takes Atractylodes macrocephala, Caulis Smilax glabra and Smilax glabra as the adjuvants for regulating qi, unblocking meridians and detoxifying, and the eight medicines are used together and mutually compatible to exert their synergistic therapeutic effects, and together play the functions of nourishing qi and nourishing the vital energy, and regulating qi and detoxifying, and have the characteristics of "eliminating evil without hurting the body's qi, and strengthening the body's qi without restraining evil".

[0056] In a preferred embodiment of the present invention, the Chinese medicine composition comprises the following raw material components by weight:

[0057] Codonopsis pilosula 13-17 parts; specifically, 13-15 parts, 15-17 parts;

[0058] 28-32 parts of Astragalus; specifically 28-30 parts, 30-32 parts;

[0059] Epimedium 13 - 17 parts; specifically, 13 - 15 parts, 15 - 17 parts;

[0060] Atractylodes macrocephala Koidz. 16 - 20 parts; specifically, 16 - 18 parts, 18 - 20 parts;

[0061] Coix seed 28 - 32 parts; specifically, 28 - 30 parts, 30 - 32 parts;

[0062] Akebia trifoliata (Thunb.) Koidz. 20 - 29 parts; specifically, 25 - 27 parts, 27 - 29 parts;

[0063] Sargentodoxa cuneata 28 - 32 parts; specifically, 28 - 30 parts, 30 - 32 parts;

[0064] Smilax glabra Roxb. 28 - 32 parts; specifically, 28 - 30 parts, 30 - 32 parts.

[0065] In a further preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw material components by weight:

[0066] Codonopsis pilosula 15 - 17 parts; preferably 15 parts;

[0067] Astragalus membranaceus (Fisch.) Bunge 30 - 32 parts; preferably 30 parts;

[0068] Epimedium 15 - 17 parts; preferably 15 parts;

[0069] Atractylodes macrocephala Koidz. 18 - 20 parts; preferably 18 parts;

[0070] Coix seed 30 - 32 parts; preferably 30 parts;

[0071] Akebia trifoliata (Thunb.) Koidz. 27 - 29 parts; preferably 27 parts;

[0072] Sargentodoxa cuneata 30 - 32 parts; preferably 30 parts;

[0073] Smilax glabra Roxb. 30 - 32 parts; preferably 30 parts.

[0074] The second aspect of the present invention provides a traditional Chinese medicine extract, which is prepared from the traditional Chinese medicine composition described in the first aspect of the present invention.

[0075] The third aspect of the present invention provides a preparation method of the above traditional Chinese medicine extract, comprising: taking each raw material component of the traditional Chinese medicine composition described in the first aspect of the present invention according to the ratio, mixing them, filtering the obtained mixture after decocting with water, and concentrating and drying the obtained extract into powder to provide the traditional Chinese medicine extract.

[0076] In a preferred embodiment of the present invention, the filtering after decocting the mixture with water comprises the following steps:

[0077] 1) Decoct the mixture with water for the first time and then filter to obtain the first extract;

[0078] 2) Filter the mixture after the second decoction with water and obtain the second extract.

[0079] 3) Combine the first extract and the second extract to obtain the extract.

[0080] In the above step 1), in the first decoction with water, the ratio of the mass (g) of the mixture added to the volume (mL) of water added is 1:6 - 10, specifically such as 1:6 - 8, 1:8 - 10, 1:7 - 9, preferably 1:7 - 9, and more preferably 1:8. That is, the water is 6 - 10 times the amount of the mixture, specifically such as 6 - 8 times, 8 - 10 times, 7 - 9 times, preferably 7 - 9 times, and more preferably 8 times.

[0081] In the above step 1), the time of the first decoction with water is 0.5 - 2 h, specifically such as 0.5 - 1 h, 1 - 2 h, 0.5 - 1.5 h, preferably 0.5 - 1.5 h, and more preferably 1 h.

[0082] In the above step 2), in the second decoction with water, the ratio of the mass (g) of the mixture added to the volume (mL) of water added is 1:6 - 10, specifically such as 1:6 - 8, 1:8 - 10, 1:7 - 9, preferably 1:7 - 9, and more preferably 1:8. That is, the water is 6 - 10 times the amount of the mixture, specifically such as 6 - 8 times, 8 - 10 times, 7 - 9 times, preferably 7 - 9 times, and more preferably 8 times.

[0083] In the above step 2), the time of the second decoction with water is 0.5 - 2 h, specifically such as 0.5 - 1 h, 1 - 2 h, 0.5 - 1.5 h, preferably 0.5 - 1.5 h, and more preferably 1 h.

[0084] In the above step 1) or 2), the filtration is screen filtration, and the mesh number of the screen for the screen filtration is 180 - 220 mesh, specifically such as 180 - 200 mesh, 200 - 220 mesh, 190 - 210 mesh, preferably 190 - 210 mesh, and more preferably 200 mesh.

[0085] In a preferred embodiment of the present invention, the concentration is vacuum concentration, and the concentration is up to 0.5 - 1.5 g of crude drug / 5 mL, specifically such as 0.5 - 1.0 g of crude drug / 5 mL, 1.0 - 1.5 g of crude drug / 5 mL, 0.8 - 1.2 g of crude drug / 5 mL, preferably 0.8 - 1.2 g of crude drug / 5 mL, and more preferably 1.0 g of crude drug / 5 mL.

[0086] In a preferred embodiment of the present invention, the drying is spray drying, and the drying conditions are as follows: the inlet air temperature is 120 - 180°C, specifically such as 120 - 150°C, 150 - 180°C, 140 - 160°C, preferably 140 - 160°C, more preferably 150°C; the liquid feeding speed is 5 - 15 mL / min, specifically such as 5 - 9 mL / min, 9 - 15 mL / min, 8 - 10 mL / min, preferably 8 - 10 mL / min, more preferably 9 mL / min; the atomization pressure is 1.00 - 1.10 bar, specifically such as 1.00 - 1.05 bar, 1.05 - 1.10 bar, 1.04 - 1.06 bar, preferably 1.04 - 1.06 bar, more preferably 1.05 bar; the outlet air temperature is 70 - 110°C, specifically such as 70 - 90°C, 90 - 110°C, 80 - 100°C, preferably 80 - 100°C, more preferably 90°C.

[0087] After extracting the active ingredients from the traditional Chinese medicine composition by the above preparation method, the aforementioned pharmaceutical composition can be prepared by using conventional pharmaceutical excipients and additives.

[0088] The fourth aspect of the present invention provides a traditional Chinese medicine preparation, which includes a therapeutically effective amount of the traditional Chinese medicine composition provided by the first aspect of the present invention, or a therapeutically effective amount of the traditional Chinese medicine extract provided by the second aspect of the present invention, and one or more conventional pharmaceutically acceptable excipients.

[0089] Pharmaceutically acceptable excipients include but are not limited to: pharmaceutically acceptable carriers, diluents, fillers, binders, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives and other excipients. Therapeutically inert inorganic or organic carriers known to those skilled in the art include but are not limited to lactose, corn starch or its derivatives, talc, vegetable oils, waxes, fats, polyhydroxy compounds such as polyethylene glycol, water, sucrose, ethanol, glycerol, and the like, various preservatives, lubricants, dispersants, flavoring agents, humectants, antioxidants, sweeteners, colorants, stabilizers, salts, buffers and the like can also be added thereto, and these substances are used as needed to help the stability of the formulation or to improve the activity or its bioavailability.

[0090] In a preferred embodiment of the present invention, the dosage forms of the traditional Chinese medicine preparation include but are not limited to tablets, capsules, pills, syrups, granules, powders, ointments, dripping pills, suspensions or emulsions.

[0091] The traditional Chinese medicine preparations of the above various dosage forms can be prepared by conventional methods. The traditional Chinese medicine preparation of the present invention can also be used together with other therapeutic agents.

[0092] The therapeutically effective amount in the present invention is, based on the total weight of the raw medicinal materials. The specific dosage should also consider factors such as the administration route and the patient's health condition, which are all within the scope of the skills of a skilled physician.

[0093] The fifth aspect of the present invention provides the use of the traditional Chinese medicine composition provided by the first aspect of the present invention, the traditional Chinese medicine extract provided by the second aspect of the present invention, or the traditional Chinese medicine preparation provided by the fourth aspect of the present invention in the preparation of a drug for treating colorectal tumors.

[0094] The present invention has the effects of strengthening the healthy qi and cultivating the root, invigorating the spleen and kidney, clearing heat and detoxifying, promoting blood circulation and removing stasis, and replenishing qi and dissipating nodules for colorectal tumors, providing an effective therapeutic drug for the clinical treatment of this refractory disease of colorectal tumors. Basic experimental studies have shown that the present invention can synergistically improve the immunosuppressive microenvironment of colorectal tumors with chemotherapy drugs, increase the local infiltration of cytotoxic T lymphocytes, and improve the possibility of clinically applying immune checkpoint inhibitors.

[0095] The following further elaborates the present invention in combination with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the protection scope of the present invention.

[0096] The following illustrates the implementation manners of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0097] For the production processes, experimental methods or detection methods involved in the examples and comparative examples of the present invention, unless otherwise specified, they are all conventional methods in the prior art, and their names and / or abbreviations are all conventional names in the art and are very clear and definite in the relevant application fields. Those skilled in the art can understand the conventional process steps according to the name and apply the corresponding equipment and implement them under conventional conditions or the conditions recommended by the manufacturer.

[0098] There are no special restrictions on the sources of various instruments, equipment, raw materials or reagents used in the examples of the present invention. They are all conventional products that can be obtained through regular commercial channels, and can also be prepared according to the conventional methods well-known to those skilled in the art.

[0099] The sources of cells, animals, and drugs involved in the following examples are as follows:

[0100] Experimental cells: SW480 human MSS-type colorectal cancer cells, purchased from the Shanghai Institute of Cell Biology, Chinese Academy of Sciences.

[0101] Experimental animals: SPF-grade 7-8-week-old B6Cg-Krastm4Tyj Apc tm1Tno Tg(CDX-cre / ERT2)752Erf / MaraJ mice (weighing 18 - 20 g) were purchased from The Jackson Laboratory, USA, and raised in the animal center of Putuo District Central Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. The experimental animal license is [SYXK (Shanghai) 2022 - 0002]. They were raised in an environment with a temperature of 21 - 25 °C and a humidity of 45% - 65%, under 12h / 12h day-night intermittent lighting. The mice were fed with standard feed and had free access to water and food. During the breeding of the mice, humane care was given in accordance with the 3R principles of animal experiment use.

[0102] Experimental drug: The drug of the present invention was converted into a gavage dose for mice of 25.35 g / kg.

[0103] In the dose conversion between humans and mice, strictly in accordance with the equivalent dose conversion formula between humans and animals in "Pharmacological Experiment Methodology", by looking up the table, the conversion coefficient between a 20 g mouse and a 70 kg human is 0.026, and the dose multiple relationship is 9.1 times. That is, the drug in Example 3 was converted into a gavage dose for mice of 25.35 g / kg (0.507 g / 20 g mouse).

[0104] Unless otherwise specified, others are all of commercial origin.

[0105] Example 1

[0106] By weight, the raw material components in the traditional Chinese medicine composition for regulating immune function and treating colorectal tumors were taken respectively as follows: 15 parts by weight of Codonopsis pilosula, 30 parts by weight of Astragalus membranaceus, 15 parts by weight of Epimedium brevicornu, 18 parts by weight of raw Atractylodes macrocephala, 30 parts by weight of Coix lacryma-jobi, 27 parts by weight of Akebia trifoliata, 30 parts by weight of Sargentodoxa cuneata, 30 parts by weight of Smilax glabra, and the traditional Chinese medicine composition sample 1# was obtained.

[0107] Example 2

[0108] By weight, the raw material components in the traditional Chinese medicine composition for regulating immune function and treating colorectal tumors were taken respectively as follows: 17 parts by weight of Codonopsis pilosula, 32 parts by weight of Astragalus membranaceus, 17 parts by weight of Epimedium brevicornu, 20 parts by weight of raw Atractylodes macrocephala, 32 parts by weight of Coix lacryma-jobi, 29 parts by weight of Akebia trifoliata, 32 parts by weight of Sargentodoxa cuneata, 32 parts by weight of Smilax glabra, and the traditional Chinese medicine composition sample 2# was obtained.

[0109] Example 3

[0110] By weight, the raw material components in the traditional Chinese medicine composition for regulating immune function and treating colorectal tumors were taken respectively as follows: 16 parts by weight of Codonopsis pilosula, 31 parts by weight of Astragalus membranaceus, 16 parts by weight of Epimedium brevicornu, 19 parts by weight of raw Atractylodes macrocephala, 31 parts by weight of Coix lacryma-jobi, 28 parts by weight of Akebia trifoliata, 31 parts by weight of Sargentodoxa cuneata, 31 parts by weight of Smilax glabra, and the traditional Chinese medicine composition sample 3# was obtained.

[0111] Example 4

[0112] By weight, take each raw material component in the traditional Chinese medicine composition for regulating immune function and treating colorectal tumors, which are respectively: 13 parts by weight of Codonopsis pilosula, 28 parts by weight of Astragalus membranaceus, 13 parts by weight of Epimedium brevicornu, 16 parts by weight of raw Atractylodes macrocephala, 28 parts by weight of Coix lacryma-jobi, 25 parts by weight of Akebia trifoliata, 28 parts by weight of Sargentodoxa cuneata, 28 parts by weight of Smilax glabra, and obtain the traditional Chinese medicine composition sample 4#.

[0113] Example 5

[0114] By weight, take each raw material component in the traditional Chinese medicine composition for regulating immune function and treating colorectal tumors, which are respectively: 14 parts by weight of Codonopsis pilosula, 29 parts by weight of Astragalus membranaceus, 14 parts by weight of Epimedium brevicornu, 17 parts by weight of raw Atractylodes macrocephala, 29 parts by weight of Coix lacryma-jobi, 26 parts by weight of Akebia trifoliata, 29 parts by weight of Sargentodoxa cuneata, 29 parts by weight of Smilax glabra, and obtain the traditional Chinese medicine composition sample 5#.

[0115] Example 6

[0116] Mix the above traditional Chinese medicine composition sample 1# according to the ratio and extract the active ingredients to obtain the traditional Chinese medicine extract sample 1*. To extract the active ingredients, first take each raw material component according to the ratio and mix them. Add 8 times the amount of water to the obtained mixture and conduct the first water decoction for 1 h, then filter through a 200-mesh sieve to obtain the first extract. Then, add 8 times the amount of water to the mixture and conduct the second water decoction for 1 h, then filter through a 200-mesh sieve to obtain the second extract. Combine the first extract and the second extract to obtain the extract. Then, concentrate the obtained extract under reduced pressure to 1.0 g of crude drug / 5 mL, and then conduct spray drying into powder to obtain. The conditions for spray drying are: the inlet air temperature is 150 °C; the liquid feeding speed is 9 mL / min; the atomization pressure is 1.05 bar; the outlet air temperature is 90 °C.

[0117] Example 7

[0118] Mix the above traditional Chinese medicine composition sample 1# according to the ratio and extract the active ingredients to obtain the traditional Chinese medicine extract sample 2*. To extract the active ingredients, first take each raw material component according to the ratio and mix them. Add 9 times the amount of water to the obtained mixture and conduct the first water decoction for 1.5 h, then filter through a 210-mesh sieve to obtain the first extract. Then, add 9 times the amount of water to the mixture and conduct the second water decoction for 1.5 h, then filter through a 210-mesh sieve to obtain the second extract. Combine the first extract and the second extract to obtain the extract. Then, concentrate the obtained extract under reduced pressure to 0.8 g of crude drug / 5 mL, and then conduct spray drying into powder to obtain. The conditions for spray drying are: the inlet air temperature is 140 °C; the liquid feeding speed is 8 mL / min; the atomization pressure is 1.00 bar; the outlet air temperature is 80 °C.

[0119] Example 8

[0120] The above traditional Chinese medicine composition sample 1# was mixed according to the ratio and then the active ingredients were extracted to obtain the traditional Chinese medicine extract sample 3*. To extract the active ingredients, first, each raw material component was taken according to the ratio and mixed. The obtained mixture was added with 7 times the amount of water and decocted for the first time for 0.5 h, then filtered through a 190-mesh sieve to obtain the first extract. Then, the mixture was added with 7 times the amount of water and decocted for the second time for 0.5 h, and then filtered through a 190-mesh sieve to obtain the second extract. The first extract and the second extract were combined to obtain the extract. Then, the obtained extract was concentrated under reduced pressure to 1.2 g of crude drug / 5 mL, and then spray-dried into powder. The conditions for spray drying were: the inlet air temperature was 160 °C; the liquid inlet speed was 10 mL / min; the atomization pressure was 1.10 bar; the outlet air temperature was 100 °C.

[0121] Parallel to Example 9

[0122] SW480 cells in the logarithmic growth phase were seeded at 8×10 3 cells / well in a 96-well plate for in vitro culture. Each group had 6 wells. The cells were cultured in RPMI 1640 medium containing 10% fetal bovine serum at 5% CO2 and 37 °C for 24 h until the cells adhered completely. The original medium was discarded, and the traditional Chinese medicine composition sample 1# prepared in Example 1 was dissolved in RPMI 1640 medium containing 10% fetal bovine serum and filtered through a 0.22-μm filter tip. The final concentrations were 1.4, 1.6, 1.8, 2.0, 2.4, 2.6, and 2.8 mg / mL, and SW480 cells were intervened for 24 h, 48 h, and 72 h respectively. After the incubation was completed, 10 μL of CCK8 reagent was added to each well, and after continuing the incubation for 1.5 h, the absorbance at 450 nm was measured with an enzyme-linked immunosorbent assay (ELISA) reader. The relative cell viability was calculated as follows.

[0123] Relative cell viability = (absorbance of the drug-treated well - absorbance of the medium) / (absorbance of the blank group - absorbance of the medium).

[0124] The results were as Figure 1 shown: After intervention with the traditional Chinese medicine composition aqueous solution at different concentrations, the viability of MSS-type human colon cancer cells SW480 decreased in a concentration-dependent manner. At the same time, with the prolongation of the intervention time, the half-maximal inhibitory concentration (IC50) of the drug gradually decreased.

[0125] Example 10

[0126] SW480 cells in the logarithmic growth phase were seeded at 8×10 5Cells were seeded at a density of [[[number of cells or pores]]] / well in a 6-well plate and divided into the following groups: control group, 5-fluorouracil group (5-Fu), traditional Chinese medicine composition group, and traditional Chinese medicine combined with 5-Fu group. Each group had 3 parallel wells. The cells were cultured in RPMI 1640 medium containing 10% fetal bovine serum in an incubator at 37°C with 5% CO2 for 24 h until the cells were completely adherent. After discarding the original medium, the following treatments were carried out: Control group: intervened with 2 ml / well of RPMI 1640 medium containing 10% fetal bovine serum; 5-Fu group: intervened with 2 ml / well of RPMI 1640 medium containing 5-Fu (concentration 0.2 μg / ml) and 10% fetal bovine serum; Traditional Chinese medicine composition group: intervened with 2 ml of RPMI 1640 medium containing the traditional Chinese medicine composition sample 1# prepared in Example 1 (concentration 1.8 mg / ml) and 10% fetal bovine serum; Traditional Chinese medicine combined with 5-Fu group: intervened with 2 ml / well of RPMI 1640 medium containing 5-Fu (concentration 0.14 μg / ml) and traditional Chinese medicine composition sample 1# (concentration 0.6 mg / ml) and 10% fetal bovine serum. After the intervention, cell proteins were extracted for Western blot analysis.

[0127] One of the main mechanisms by which the immune system recognizes pathogenic microorganisms is to recognize their nucleic acids. Cyclic GMP-AMP synthase (cGAS) is a cytosolic DNA sensor that activates the cGAS-STING pathway upon sensing pathogenic DNA. This pathway not only mediates innate immune responses to resist infections by various DNA-containing pathogenic microorganisms but also senses tumor-derived DNA to generate anti-tumor immune responses, producing type I interferons and triggering immune responses, increasing antigen exposure. After type I IFN (IFN-α and IFN-β) binds to cell surface receptors (such as IFNA-R1), it can increase the expression of PD-L1. In addition, STAT1 can undergo tyrosine phosphorylation and interact with various proteins, including IFNAR1, IFNAR2, IFNGR1, etc., which contributes to its diverse cellular functions.

[0128] The results were as Figure 2 shown: After the intervention of traditional Chinese medicine composition combined with 5-Fu on SW480 cells, the expressions of STAT1, PD-L1, and IFNA-R1 were upregulated compared with other groups. The level of STING protein showed no obvious change, but the level of p-STING was upregulated, indicating that traditional Chinese medicine composition combined with 5-Fu can regulate the protein expressions of STAT1, PD-L1, and IFNA-R1 in tumor cells in vitro, promote STING phosphorylation, which changes the immune status of SW480 MSS-type human colorectal cancer cells, may be related to enhancing the immunogenicity of colorectal cancer cells and increasing the release of type I interferons, and is expected to enhance the immunotherapy effect when combined with PD-L1.

[0129] Example 11

[0130] The pharmacodynamic experiment of the traditional Chinese medicine composition in the present invention and its combination with capecitabine against MSS-type colorectal tumors was carried out as follows:

[0131] 1. Preparation of MSS-type colorectal tumor mouse model: Forty SPF-grade B6Cg-Krastm4TyjApctm1Tno Tg(CDX-cre / ERT2)752Erf / MaraJ mice, 7-8 weeks old and weighing 18-20 g, were selected. Tamoxifen powder was weighed and dissolved in corn oil (concentration: 10 mg / ml). After complete dissolution, intraperitoneal injection was used to induce the growth of intestinal tumors (induction dose: 1 mg / 20 g body weight), and the induction time was 4 weeks.

[0132] 2. Experimental grouping and drug intervention: After 4 weeks, the 40 mice were randomly divided into 4 groups, namely the model group (Model), the traditional Chinese medicine group, the capecitabine group (Capecitabine), and the traditional Chinese medicine combined with capecitabine group (Combination).

[0133] Model group: Given 0.9% normal saline by gavage, dose: 0.4 ml / 20 g body weight, once a day for 21 days.

[0134] Traditional Chinese medicine group: The dry powder of the traditional Chinese medicine composition 1 prepared in Example 1 was dissolved in 0.9% normal saline and given by gavage, dose: 0.507 g / 20 g body weight, once a day for 21 days.

[0135] Capecitabine group: Capecitabine powder was dissolved in 0.9% normal saline and given by gavage, dose: 1 mg / 20 g body weight, once a day for 21 days.

[0136] Traditional Chinese medicine combined with capecitabine group: The traditional Chinese medicine composition 1 prepared in Example 1 and capecitabine were given at the above dose: 1 mg / 20 g body weight, once a day for each, with an interval of 8 h, for 21 days.

[0137] 3. Specimen collection method: At the end of 21 days of treatment, the mice were sacrificed by cervical dislocation after anesthesia. The eyeballs were removed to collect blood, which was allowed to stand at room temperature for 1 h and then centrifuged at 3000 rpm for 5 min to collect the serum, which was stored in a -80 °C refrigerator for later use. The tissue from the cecum to the anus was taken out and quickly placed in a petri dish containing pre-cooled normal saline. A 5 mL syringe was filled with pre-cooled normal saline, the syringe needle was removed, and the intestinal segment was repeatedly rinsed to remove all feces. The intestinal segment was carefully longitudinally dissected with scissors, and the remaining feces were removed by rinsing with normal saline again. The excess normal saline was blotted with filter paper. The inner wall of the intestinal segment was facing up and laid flat on A4 paper. After photographing and recording, the intestinal segment was placed on an ice box for tumor counting. After counting, the intestinal segment containing tumors was cut and fixed at room temperature in 10% (v / v) formalin, routinely paraffin-embedded, and sectioned with a thickness of 4 - 5 mm. Immunohistochemical examination and immunofluorescence co-staining were performed successively. The tumor mass of the remaining intestinal segment was immediately removed, frozen in liquid nitrogen, and stored in a -80 °C refrigerator for later use.

[0138] 4. Observation items:

[0139] (1) General condition of the mice: During the treatment period, the activities, mental state, food and water intake, fecal shape, and hair color of the mice were observed, and the body weight was recorded.

[0140] (2) Number and size of colorectal tumors in the mice.

[0141] (3) Observation of the proliferation (Ki-67) and PD-L1 expression level in the colorectal of the mice by immunohistochemistry.

[0142] (4) Immunofluorescence co-staining to observe CD8 + , Granzyme B + T cell numbers in the colorectal tumors of the mice.

[0143] (5) Determination of the levels of immune cytokines IFN-β and IFN-γ in the serum of the mice by ELISA.

[0144] (6) Reverse transcription and fluorescence real-time quantitative PCR to determine the mRNA expression levels of chemokines CXCL10 and CCL5 in the colorectal tumors of the mice.

[0145] (7) Protein immunoblotting assay to detect the protein expression of cGAS, STING, p-STING, and PD-L1 in the colorectal tumors of the mice.

[0146] (8) Liver function (alanine aminotransferase, aspartate aminotransferase, total bilirubin) and kidney function (serum creatinine, blood urea nitrogen) of the mice.

[0147] 5. Statistical analysis: Data were processed using GraphPad 9.5.1 statistical software. Results were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups. A P value < 0.05 was considered statistically significant (*P < 0.05, **P < 0.01, ***P < 0.001, ns: no significant in the attached figures).

[0148] 6. Research results

[0149] 6.1 Number and size of mouse colon tumors: After the experiment, the abdomen of the mice was longitudinally dissected, and the cecum to anus segment of the mice was separated and longitudinally opened and laid flat on A4 paper. The size and number of tumors were counted. The results showed that Figure 3 different degrees of tumor nodules appeared in the colorectal segments of mice in each group, indicating that the tamoxifen-induced colorectal in-situ tumor model was successful. At the same time, after intervention with the traditional Chinese medicine composition of the present invention and capecitabine, the number of tumors that occurred was reduced and the volume was decreased compared with the model group, and the combination of traditional Chinese medicine and capecitabine group was the most obvious, indicating that the traditional Chinese medicine composition of the present invention can reduce the incidence rate and tumor burden of tamoxifen-induced mouse colon tumors and improve the therapeutic effect of capecitabine.

[0150] 6.2 Proliferation of mouse colorectal and PD-L1 expression level: Abnormal proliferation of cells is an important factor in the occurrence and development of tumors. The non-expression / low expression of PD-L1 is one of the main difficulties in current clinical immunotherapy for colorectal cancer. To verify the effect of the traditional Chinese medicine composition of the present invention or the combination of traditional Chinese medicine and capecitabine on the expression of Ki-67 and PD-L1 in mouse colorectal tumors, Ki-67 and PD-L1 were stained by immunohistochemistry.

[0151] As Figure 4 shown, both the capecitabine group and the traditional Chinese medicine group could reduce the expression of Ki67 in colorectal tumors and increase the expression of PD-L1, and the combination of traditional Chinese medicine and capecitabine group was the most obvious. The results showed that the combination drug group could inhibit the proliferation activity of abnormal intestinal epithelial cells, increase the expression of immune checkpoint PD-L1 in colorectal tumors, improve the tumor immunosuppressive microenvironment, and may enhance the reactivity of PD-L1 inhibitors.

[0152] 6.3 Number of CD8 + and Granzyme B + T cells in mouse colorectal tumors: Cytotoxic T lymphocytes are important adaptive immune cells participating in the body's anti-tumor response and can produce a variety of cytotoxic mediators to kill target cells, including perforin, granzyme, interferon, and tumor necrosis factor.

[0153] As Figure 5The results of immunofluorescence co-staining showed that: compared with other groups, the number of cells with co-localization of CD8 and Granzyme B immunofluorescence in the traditional Chinese medicine group combined with capecitabine group was significantly increased. It can be seen that the combined medication promoted the local infiltration of cytotoxic T lymphocytes in tumors and produced more granzyme B, indicating that after combined treatment, the cytotoxic function of CD8 + T cells was enhanced, the killing effect on tumors was enhanced, the immunosuppressive microenvironment was reversed to a certain extent, and the "cold tumor" was transformed into a "hot tumor".

[0154] 6.4 Levels of immune factors IFN-β and IFN-γ in mouse serum: IFN-β and IFN-γ are important interferon cytokines and play a key role in coordinating innate immune responses against various challenges, including infections, tumor development, and inflammatory stimuli. They are crucial for controlling the growth of tumor cells in terms of inducing apoptosis and anti-proliferation pathways.

[0155] The results were as Figure 6 shown. The levels of IFN-β and IFN-γ in the serum of mice in the capecitabine group and the traditional Chinese medicine group combined with capecitabine group were significantly higher than those in the model group, and the increase was most obvious in the traditional Chinese medicine group combined with capecitabine group, indicating that the combined medication could enhance the production of IFN-β and IFN-γ in mice more effectively than capecitabine treatment alone and regulate the anti-tumor immune response.

[0156] 6.5 Expression levels of chemokines CXCL10 and CCL5 mRNA in mouse colorectal tumors: CXCL10 and CCL5 are cytokines in the chemokine family, which can promote the chemotactic activity of various immune cells, induce apoptosis, regulate cell growth and proliferation, and participate in processes such as inflammation maintenance, transplantation, antiviral immunity, and tumor development.

[0157] As Figure 7 shown, the expression levels of CXCL10 and CCL5 mRNA in tumors of the capecitabine group and the traditional Chinese medicine group combined with capecitabine group were higher than those in the model group, and the increase was most obvious in the traditional Chinese medicine group combined with capecitabine group, indicating that the combined medication could enhance the transcription of local chemokines CXCL10 and CCL5 in tumors more effectively than capecitabine treatment alone, thereby further promoting the migration of immune cells such as T lymphocytes, NK cells, and dendritic cells.

[0158] 6.6 As Figure 8 shown, the expressions of cGAS, PD-L1, and p-STING in tumors of the traditional Chinese medicine group combined with capecitabine group were up-regulated compared with other groups, and the phosphorylation of STING increased, indicating that the combined medication could activate the cGAS-STING pathway, increase the secretion of type I interferon, improve the immunosuppressive microenvironment of colorectal tumors in MSS mice, and increase the positive expression of PD-L1.

[0159] 6.7 As Figure 9As shown, after drug treatment, the liver function (alanine aminotransferase, aspartate aminotransferase, total bilirubin) and kidney function (serum creatinine, blood urea nitrogen) of each group of mice did not show damage, indicating that the combined use of drugs is safe.

[0160] As described above, only the preferred embodiments of the present invention are given, and there is no limitation in any form and essence to the present invention. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the method of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention. For those who are familiar with this professional technology, without departing from the spirit and scope of the present invention, any equivalent changes made by using the technical content disclosed above, such as slight changes, modifications and evolutions, are all equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments according to the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition, comprising the following raw material components by weight: 10-30 parts of Codonopsis pilosula; Astragalus 20-35 parts; 10-20 portions of Epimedium; 10-25 parts of raw Atractylodes macrocephala; 20-35 parts coix seeds; 15-30 August cards; 15-30 parts of red vine; 20-30 servings of Smilax glabra.

2. The Chinese medicine extract according to claim 1, characterized in that By weight, it includes the following raw material components: 13-17 parts of Codonopsis pilosula; Astragalus 28-32 parts; 13-17 portions of Epimedium; 16-20 parts of raw Atractylodes macrocephala; 28-32 servings of coix seed; August 20-29 pieces; 28-32 parts of red vine; 28-32 servings of Smilax glabra.

3. A Chinese medicine extract obtained by extracting the Chinese medicine composition according to any one of claims 1-2 as raw material.

4. The method for preparing the Chinese medicine extract according to claim 3, comprising: The raw material components of the Chinese medicine composition according to any one of claims 1-2 are mixed according to the ratio, the obtained mixture is decocted with water and then filtered, and the obtained extract is concentrated and dried into powder to provide the Chinese medicine extract.

5. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: The mixture is boiled with water and then filtered, comprising the following steps: 1) boiling the mixture with water for the first time and filtering it to obtain a first extract; 2) boiling the mixture for a second time and filtering it to obtain a second extract; 3) combining the first extract and the second extract to obtain an extract.

6. The method for preparing the Chinese medicine extract according to claim 5, characterized in that: Includes any one or more of the following conditions: A1) In step 1), in the first decoction, the ratio of the mass of the mixture added to the volume of water added is 1:6-10, g / mL; A2) in step 1), the first decoction time is 0.5-2h; A3) In step 2), during the second decoction, the ratio of the mass of the mixture added to the volume of water added is 1:6-10, g / mL; A4) in step 2), the second decoction time is 0.5-2h; A5) In step 1) or 2), the filtration is performed by sieve filtration, and the mesh number of the sieve filtration is 180-220 meshes.

7. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: The concentration is reduced pressure concentration, and the concentration is to 0.5-1.5 g crude drug / 5 mL.

8. The method for preparing the Chinese medicine extract according to claim 4, characterized in that: The drying is spray drying, and the drying conditions are: air inlet temperature is 120-180°C; liquid inlet speed is 5-15mL / min; atomization pressure is 1.00-1.10bar; and air outlet temperature is 70-110°C.

9. A Chinese medicine preparation comprising a therapeutically effective amount of the Chinese medicine composition according to any one of claims 1 to 2, or a therapeutically effective amount of the Chinese medicine extract according to claim 3, and one or more conventional pharmaceutically acceptable excipients.

10. The Chinese medicine composition according to any one of claims 1-2, Use of the Chinese medicine extract according to claim 3 or the Chinese medicine preparation according to claim 9 in the preparation of a medicament for treating colorectal tumors.

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