Traditional Chinese medicine composition for treating lung cancer and application thereof

By developing a traditional Chinese medicine composition containing components such as red ginseng, northern ginseng, aparagus, coix seed, gecko, toad skin, dragon syrup and fritillaria, the traditional Chinese medicine composition for treating lung cancer in the prior art has been solved. The therapeutic effect of the traditional Chinese medicine composition for treating lung cancer in the prior art is solved. The problem of major toxic side effects has achieved significant tumor inhibition and immune regulation, and the toxic side effects are relatively small.

CN119424576APending Publication Date: 2025-02-14SHENZHEN BAOAN PURE TCM TREATMENT HOSPITAL +1
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Patent Information

Application Number
CN202310991039.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-08-07
Publication Date
2025-02-14

AI Technical Summary

Technical Problem

In the prior art, the traditional Chinese medicine composition for treating lung cancer has problems of inaccurate efficacy and major toxic side effects. It is urgent to develop an anti-cancer traditional Chinese medicine composition with accurate efficacy and minor toxic side effects.

Method used

Provide a traditional Chinese medicine composition, including red ginseng, northern ginseng, aparagus, coix seed, gecko, toad skin, dragon sunflower and fritillaria, etc., through strengthening the spleen and replenishing qi, removing dampness and phlegm, detoxifying and removing blood stasis, dispersing knots The effect of cough relieving is suitable for the treatment of lung cancer and metastatic patients.

Benefits of technology

In animal experiments in mouse lung cancer ectopic tumor transplantation model, this traditional Chinese medicine composition significantly inhibits tumor growth, has significant tumor inhibition and immunomodulation effects, outstanding therapeutic effects, and has fewer toxic side effects, and has good practical application value.

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Abstract

The invention relates to a traditional Chinese medicine composition for treating lung cancer and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-20% of red ginseng, 10-20% of radix glehniae, 10-20% of rhizoma arisaematis, 10-40% of coix seeds, 5-10% of gecko, 5-10% of toad skin, 10-20% of black nightshade and 10-20% of Based on animal experiments of a mouse lung cancer transplantation tumor model, the traditional Chinese medicine composition has remarkable tumor inhibition and immunoregulation effects, can remarkably prolong the lifetime of a C57BL / 6 lung cancer mouse, remarkably inhibit tumor growth, improve the proportion of CD4 + and CD8 + T cells of the spleen, increase the proportion of dendritic cells (DC) in a tumor microenvironment and reduce the proportion of myeloid-derived suppressor cells (PMN-MDSC), and can be used for preparing a medicine for treating the lung cancer. The curative effect is prominent.
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Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine and medical preparations, and in particular to a traditional Chinese medicine composition for treating lung cancer and application thereof. Background Art

[0002] Traditional Chinese medicine combined with surgery, radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy can improve tumor symptoms, reduce recurrence and metastasis after treatment, and prolong survival [1]. Various traditional Chinese medicine compounds and their effective components can exert multi-pathway, multi-target and multi-effect anti-tumor effects by improving the body's immune function, regulating the tumor immune microenvironment, inhibiting angiogenesis and inducing tumor cell apoptosis [1]. Therefore, it is of great significance to discover effective anti-tumor prescriptions from traditional Chinese medicine.

[0003] According to TCM theory, lung cancer belongs to the category of "lung accumulation" and "breath congestion" in TCM. The overall nature of the disease is due to deficiency leading to excess. The deficiency is more common in the lungs and spleen, while the excess is caused by phlegm and blood stasis. Long-term disease enters the meridians, and deficiency of the body and phlegm stagnation are the key pathogenesis of lung cancer occurrence and metastasis. "Yinqi and phlegm removal" is the main treatment method for preventing and treating lung cancer in TCM.

[0004] In previous literature, a journal article [2] disclosed the inhibitory effect of Yiqi Chutan prescription on the epithelial-mesenchymal transition of lung cancer cells. The prescription is mainly composed of 6 herbs: ginseng, coix seed, arisaema, nightshade, toad venom, gecko, and toad skin. The journal article [3] disclosed that Yiqi Chutan prescription has a good therapeutic effect in the clinical treatment of lung cancer. The prescription is composed of 15g of Codonopsis pilosula, 15g of raw Pinellia, 15g of Trillium, 6g of gecko, 15g of Fritillaria thunbergii, 30g of Agrimoniae, and 15g of Poria.

[0005] Compared with the prescription mentioned in the journal document [2], the Chinese medicine composition of the present invention replaces ginseng with red ginseng, adds Adenophora australis and Fritillaria thunbergii, and removes toad venom. The main ingredients of the Chinese medicine composition of the present invention are red ginseng and Adenophora australis. Red ginseng is made by steaming and then drying ginseng. It is better produced in Jilin and is easier to absorb than unprocessed ginseng. Its qi-tonifying effect is stronger than that of ginseng. In addition, red ginseng has a blood-tonifying effect. It has the functions of both qi-tonifying and blood-nourishing, and helps to improve the body's immunity. Adenophora australis nourishes yin and clears the lungs, benefits the stomach and produces body fluids.

[0006] The "New Compendium of Materia Medica" states that it "specially nourishes the lung yin, clears the lung fire, and treats chronic cough and lung atrophy". The two are both the main drugs, which not only have a strong effect on nourishing the lung and spleen qi, but also can nourish the lung yin and relieve cough and resolve phlegm. In addition, the fritillaria thunbergii can clear away heat and resolve phlegm, relieve depression and resolve stagnation, while the toad venom, which is toxic and not suitable for use in decoctions, is removed, which not only reduces the toxic and side effects of the present invention, but also makes the preparation of the present invention more flexible. Therefore, the Chinese medicine composition of the present invention has a stronger effect of nourishing the lung, resolving phlegm and resolving stagnation, less toxic and side effects, and more flexible preparation than the prescription mentioned in the journal literature [2].

[0007] The Chinese medicine composition of the present invention is different from the prescription mentioned in the journal document [2] in that: the Chinese medicine composition of the present invention contains red ginseng, which greatly replenishes vital energy, and northern adenophora, which nourishes yin and clears the lungs, and has a stronger lung-replenishing effect. It also contains Solanum nigrum, which relieves cough and eliminates phlegm, and toad skin, which "fights poison with poison", and has a stronger heat-clearing, detoxifying and stagnation-dispersing effect. The Chinese medicine composition of the present invention removes toxic raw pinellia and trillium, which reduces toxic and side effects. Therefore, the Chinese medicine composition of the present invention has a stronger lung-replenishing, phlegm-resolving and stagnation-dispersing effect and less toxic and side effects than the prescription mentioned in the journal document [2].

[0008] Although there are different drug combination schemes under the treatment principle of "invigorating qi and removing phlegm", the development of anticancer Chinese medicine compositions with definite efficacy and few toxic and side effects is still an urgent problem to be solved. The Chinese medicine composition of the present invention mainly invigorates qi and removes phlegm, and also has the functions of detoxifying and removing blood stasis, softening and dispersing nodules, and treating both the symptoms and the root causes, and is suitable for the treatment of patients with lung cancer and metastasis.

[0009] There is currently no report on the use of the Chinese medicine composition of the present application to treat lung cancer. Summary of the invention

[0011] The purpose of the present invention is to provide a Chinese medicine composition for treating lung cancer in view of the deficiencies of the prior art; and to provide a method for preparing the Chinese medicine composition.

[0012] 1. To achieve the above object, the technical solution adopted by the present invention is as follows:

[0013] Provided is a Chinese medicine composition for treating lung cancer, which is composed of effective Chinese medicine components and medically acceptable excipients, wherein the effective Chinese medicine components are made of the following raw materials:

[0014] A traditional Chinese medicine composition for treating lung cancer is prepared from the following raw materials in parts by weight: 10-20% of red ginseng, 10-20% of northern adenophora, 10-20% of arisaema, 10-40% of coix seed, 5-10% of gecko, 5-10% of toad skin, 10-20% of solanum nigrum and 10-20% of thunbergii bulb.

[0015] Preferably, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 10-20% red ginseng, 10-20% northern adenophora, 10-15% arisaema, 15-25% coix seed, 5-10% gecko, 5-10% toad skin, 10-20% solanum nigrum, and 15-20% thunbergii bulb.

[0016] The optimal ratio of the raw materials of the Chinese medicine composition of the present invention is:

[0017] Red ginseng 11.5%, northern adenophora 11.5%, arisaema 11.5%, coix seed 22.9%, gecko 4.6%, toad skin 7.6%, Solanum nigrum 15.3%, Fritillaria thunbergii 15.3%.

[0018] Preferably, the Chinese medicine composition further comprises a pharmaceutically acceptable conventional carrier, including: an emulsifier, a filler, a binder, a wetting agent, a disintegrant, an absorption promoter, a flavoring agent, a colorant, and a solubilizing agent. However, those skilled in the art will also know that the pharmaceutical carriers that can be used in the present invention are not limited to the above types.

[0019] Preferably, the dosage form of the Chinese medicine composition includes, but is not limited to, decoction, pills, tablets, mixtures, capsules, granules, powders, pastes or wines.

[0020] In order to realize the application of the above-mentioned Chinese medicine composition in the preparation of a medicine for treating lung cancer, the technical solution adopted by the present invention is:

[0021] The preparation method can use a variety of preparation methods to process the raw material into medicine. The processing includes but is not limited to: crushing, water extraction, organic solvent, supercritical extraction, etc. More specifically, the processing includes the steps of weighing, crushing, decoction, precipitation, etc.

[0022] The dosage form may include, but is not limited to, decoction, pill, tablet, mixture, capsule, granule, powder, paste or wine. In the preparation process, other pharmaceutically (or food science or health care product science) acceptable carriers may also be selectively added.

[0023] 2. The beneficial effects of the oral medication described in the present invention are further confirmed by the following studies.

[0024] In an animal experiment of a mouse lung cancer heterotopic transplant tumor model, a therapeutically effective dose of the pharmaceutical composition is administered to a subject.

[0025] The Chinese medicine composition of the present invention can be directly used to treat lung cancer. The Chinese medicine composition of the present invention can also contain other optional medicinal materials or medicinal material extracts.

[0026] The dosage of the Chinese medicine composition of the present invention may vary with the mode of administration, dosage form and severity of the disease to be treated. However, generally, satisfactory results can be obtained when the composition of the present invention is administered at a dosage of about 0.02 to 2 g / kg of animal body weight per day. For most large mammals, the total daily dose is about 0.1 to 50 g, preferably about 0.5 to 20 g. This dosage regimen can be adjusted to provide the best therapeutic effect. For example, a single dose may be administered several times a day, or the dose may be reduced proportionally, or administered in a sustained release form, depending on the needs of the treatment condition. Of course, the specific dosage should also take into account factors such as the mode of administration and the physical condition of the subject of administration, which are all within the skill range of the art.

[0027] 3. Compared with the prior art, the above one or more technical solutions have achieved the following beneficial effects:

[0028] The above technical scheme provides a Chinese medicine composition for treating lung cancer. Animal experiments based on mouse lung cancer heterotopic transplant tumor models have proved that the Chinese medicine composition of the present invention has significant tumor inhibition and immunomodulatory effects, and has outstanding therapeutic effects. At the same time, the scientific formulation fully considers the water-soluble and fat-soluble effective ingredients to establish a variety of Chinese medicinal materials extraction processes, so it has good practical application value.

[0029] 4. The advantages of the present invention are:

[0030] 1) According to the TCM theory of nourishing the earth to produce metal, a Chinese medicine composition that strengthens the spleen and replenishes qi, removes dampness and resolves phlegm is used to implement the "replenishing qi and removing phlegm" treatment method, improve the key pathogenesis of "deficiency of body fluid and phlegm stagnation" in the occurrence and metastasis of lung cancer, and achieve the purpose of resisting the invasion and metastasis of lung cancer.

[0031] According to the theory of traditional Chinese medicine, the overall nature of lung cancer is due to deficiency. The deficiency of the lung and spleen is common, while the deficiency of the symptoms is caused by phlegm and blood stasis. Long-term illness enters the collaterals, and the phlegm stagnation of the body is the key pathogenesis of lung cancer metastasis. In the prescription, red ginseng belongs to the spleen and lung meridians, greatly replenishes the vital energy, replenishes the spleen and lungs, and is regarded as a special medicine for replenishing spleen qi in the Compendium of Materia Medica; northern ginseng belongs to the lung and stomach meridians, nourishes yin and clears the lungs, and relieves phlegm and coughs, and is the main medicine. The combination of the two medicines can play the effects of replenishing the spleen and lungs, cultivating soil and producing gold, and replenishing qi and removing phlegm. Arisaema is bitter in taste, pungent and warm in nature, can dry dampness and resolve phlegm, reduce swelling and disperse knots, and is often used to treat stubborn phlegm cough and chest and diaphragm stuffiness; coix is ​​sweet, light and slightly cold, belongs to the spleen, stomach, and lung meridians, and can penetrate, clear and replenish. It can not only clear dampness and heat, remove numbness and discharge pus, but also slightly strengthen the spleen; the combination of the two medicines enhances the power of removing dampness and resolving phlegm. Gecko tastes salty and is cold in nature, with a little poison. It is good at dispelling wind, activating collaterals, detoxifying and dispersing knots; toad skin can clear away heat and detoxify, promote diuresis and relieve swelling. The two medicines also imply "fighting poison with poison", and their combined use enhances the power of reducing swelling and dispersing knots. The above four herbs are collectively the ministerial drugs, which are used for their functions of dispelling dampness, resolving phlegm and dispersing knots to help the effect of "invigorating qi and strengthening the spleen". Solanum nigrum is bitter and cold, clears heat and activates blood circulation, relieves cough and eliminates phlegm; Fritillaria thunbergii belongs to the lung meridian, clears heat and dispersing knots, resolves phlegm and relieves cough; the two herbs are collectively the adjuvants, which can not only resolve phlegm and relieve cough, but also clear heat and dissipate knots, which helps to improve the phlegm and wheezing symptoms caused by the mutual accumulation of phlegm and blood stasis in patients. Overall, the whole prescription is mainly to invigorate qi and eliminate phlegm, and also to detoxify and resolve blood stasis, disperse knots and relieve cough, and treat both the symptoms and the root causes. It is suitable for the treatment of lung cancer and metastasis patients.

[0032] 2) The Chinese medicine composition of the present invention is made of pure Chinese medicine and has less toxic and side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1This is the effect of the Chinese medicine composition of the present invention on the tumor growth of Lewis lung cancer mice in Example 6 of the present invention. In the figure, it is marked: M: model group; SD: low-dose group of the Chinese medicine composition of the present invention by water extraction process; SZ: medium-dose group of the Chinese medicine composition of the present invention by water extraction process; CCD: low-dose group of the Chinese medicine composition of the present invention by water extraction and alcohol precipitation process; CCZ: medium-dose group of the Chinese medicine composition of the present invention by water extraction and alcohol precipitation process; CTD: low-dose group of the Chinese medicine composition of the present invention by alcohol extraction process; CTZ: medium-dose group of the Chinese medicine composition of the present invention by alcohol extraction process; DDP: positive control cisplatin group. Statistical mark: ****p<0.0001, drug administration group compared with model group (M).

[0034] Figure 2 The effect of the Chinese medicine composition of the present invention on the body weight of Lewis lung cancer mice in Example 7 of the present invention. Figure 1 .

[0035] Figure 3 The effect of the Chinese medicine composition of the present invention on the number of dendritic cells in the tumor microenvironment of Lewis lung cancer mice in Example 8 of the present invention. Figure 1 Statistical symbols: ***p<0.001, **p<0.01, *p<0.05, comparison between drug-treated group and model group (M).

[0036] Figure 4 This is the effect of the Chinese medicine composition of the present invention on the number of TAMs in the tumor microenvironment of Lewis lung cancer mice in Example 9 of the present invention. Figure 1 Statistical symbols: ***p<0.001, **p<0.01, *p<0.05, comparison between drug-treated group and model group (M).

[0037] Figure 5 The effect of the Chinese medicine composition of the present invention on the number of T cells in the spleen of Lewis lung cancer mice in Example 10 of the present invention. Figure 1 Statistical symbols: ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05, comparison between drug-treated group and model group (M); ##p<0.01, comparison between blank control group and model group (M).

[0038] Figure 6 The effect of the Chinese medicine composition of the present invention on the number of T cells in the spleen of Lewis lung cancer mice in Example 11 of the present invention. Figure 1 Statistical symbols: ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05, comparison between drug-treated group and model group (M); ##p<0.01, comparison between blank control group and model group (M). DETAILED DESCRIPTION

[0039] 1. The specific implementation methods provided by the present invention are described in detail below.

[0040] In a typical embodiment of the present invention, a Chinese medicine composition for treating lung cancer is provided, wherein the Chinese medicine composition for treating lung cancer comprises the following raw materials in weight: 11.5% red ginseng, 11.5% northern radix adenophorae, 11.5% arisaema, 22.9% coix seed, 4.6% gecko, 7.6% toad skin, 15.3% solanum nigrum, and 15.3% thunbergii. The efficacy of the above core Chinese medicine composition for treating lung cancer is specifically manifested in any one or more of the following effects:

[0041] a) inhibiting tumor cell proliferation; b) inhibiting tumor cell migration; c) inhibiting tumor cell invasion; d) inhibiting tumor growth; e) regulating subject macrophage polarization; f) restoring the proliferation capacity of subject T lymphocytes and DC cells, improving subject cellular immune function; g) improving the immunosuppressive activity of subject Treg cells and MDSC cells. Wherein, the tumor is lung cancer. The subject refers to an animal that has been the subject of treatment, observation or experiment, preferably a mammal (such as a mouse, a human, etc.).

[0042] 2. In another specific embodiment of the present invention, a method for preparing the above-mentioned Chinese medicine composition is provided, the method comprising the following steps:

[0043] Example 1: Preparation of the aqueous extract of the Chinese medicine composition of the present invention (I)

[0044] The above raw medicinal materials were added with 10 times, 8 times and 6 times the amount of water respectively and decocted for 3 times, each time for 1 hour. The filtrates were combined and concentrated to an appropriate concentration.

[0045] Example 2: Preparation of the water-extracted alcohol-precipitated solution of the Chinese medicine composition of the present invention (II)

[0046] The above raw medicinal materials were added with 10 times, 8 times and 6 times the amount of water respectively and decocted for 3 times, each time for 1 hour. The filtrates were combined and concentrated to a relative density of 1.10, cooled to room temperature, and ethanol was added to a final concentration of 70%. The mixture was allowed to stand, the supernatant was filtered and concentrated to an appropriate concentration.

[0047] Example 3: Preparation of the alcohol extract of the Chinese medicine composition of the present invention (III)

[0048] The above raw medicinal materials are crushed, 10 times the amount of ethanol and 8 times the amount of ethanol are added, heated and refluxed for extraction, and the filtrates are filtered, combined, and concentrated to obtain an alcohol extract.

[0049] 3. The technical solution of the present invention will be described in detail below in conjunction with specific embodiments.

[0050] 3.1 Example of preparation of drug solution:

[0051] Example 1: The inventor prepared the Chinese herbal medicine extract of Example 1 by the following process: take 15g of Arisaema, add 10 times the amount of deionized water, soak for half an hour, heat and reflux and decocted for one hour; at the same time, take 15g of Adenophora australis, 6g of Gecko, 30g of Coix seeds, 20g of Solanum nigrum, 20g of Fritillaria thunbergii, and 10g of Toad skin, add 10 times the amount of deionized water, and soak for half an hour. Arisaema is decocted first, and its extract is combined with the residue into the above mixed herbal medicine soaking liquid, heated and refluxed for extraction for 1 hour, filtered to obtain the filtrate, and then 8 times the amount of water and 6 times the amount of water are added respectively, heated and refluxed for extraction for 1 hour. Combine the three filtrates and concentrate under reduced pressure to an appropriate amount. Take 15g of red ginseng and decocted separately, the method is the same as before.

[0052] Example 2: The inventor prepared the Chinese herbal medicine extract of Example 2 by the following process: Take 15g of Arisaema, add 10 times the amount of deionized water, soak for half an hour, heat and reflux and decocted for one hour; at the same time, take 15g of Adenophora australis, 6g of Gecko, 30g of Coix seeds, 20g of Solanum nigrum, 20g of Fritillaria thunbergii, and 10g of Toad skin, add 10 times the amount of deionized water, and soak for half an hour. Arisaema is first decocted, and its extract is combined with the residue into the above mixed herbal medicine soaking liquid, heated and refluxed for extraction for 1 hour, filtered to obtain the filtrate, and then 8 times the amount of water and 6 times the amount of water are added to heat and reflux for extraction for 1 hour. Combine the three filtrates, concentrate under reduced pressure to a relative density of 1.10, cool to room temperature, add 95% ethanol, slowly stir until the final concentration of ethanol is 70%, stand overnight, filter to obtain the filtrate, reduce pressure to recover ethanol, and concentrate to an appropriate amount. Take another 15g of red ginseng and extract it separately, the method is the same as before.

[0053] Example 3: The inventor prepared the Chinese herbal medicine extract of Example 3 by the following process: take 15g of Arisaema, 15g of Red Ginseng, 15g of Adenophora australis, 6g of Gecko, 30g of Coix Seed, 20g of Solanum nigrum, 20g of Fritillaria thunbergii, 10g of Toad Skin, add 10 times the amount of 70% ethanol, heat and reflux for extraction for 2 hours, filter to obtain a filtrate, then add 8 times the amount of 70% ethanol and heat and reflux for extraction for 1.5 hours. Combine the two filtrates, concentrate under reduced pressure to a relative density of 1.10, cool to room temperature, add 95% ethanol, slowly stir until the final concentration of ethanol is 70%, stand overnight, filter to obtain a filtrate, recover ethanol under reduced pressure, concentrate to an appropriate amount, add Tween-80 to a final concentration of 2%, and mix evenly.

[0054] 3.2 In vivo efficacy study example:

[0055] Example 4: Establishment of Lewis lung cancer mouse model. After one week of adaptive feeding, 6-8 week old male C57BL / 6L mice were subcutaneously inoculated with Lewis lung cancer cells (LLC) to construct a Lewis lung cancer model. The steps were as follows: LLC cells in the exponential growth phase were taken, digested with 0.25% trypsin, washed with sterile PBS, centrifuged at 160g for 10 minutes, the supernatant cell pellet was discarded, and the cell concentration was adjusted to 5×10 6 Wipe the right abdominal skin of the mouse with 75% alcohol, draw 0.2 mL of cell suspension with a 1 mL sterile syringe, and inject subcutaneously into the right forelimb armpit of the mouse to establish Lewis lung cancer mouse model.

[0056] Example 5: Lewis lung cancer mouse drug administration experiment After inoculation, when the volume of the mouse tumor is half larger than 50mm 3 The C57BL / 6J mice were randomly divided into a blank control group, a model group, a Chinese medicine composition group, and a positive control group, with 12 mice in each group. The Chinese medicine composition extract prepared in Example 1, Example 2, and Example 3 was administered by gavage, the low-dose administration amount was equivalent to 9.825 g of the original medicinal material / kg body weight, the medium-dose administration amount was equivalent to 19.65 g of the original medicinal material / kg body weight (equivalent to the clinical equivalent dose), the gavage volume was 0.2 mL / 10 g body weight, and the gavage was performed once a day for 17 consecutive days; the positive control group was given cisplatin 2 mg / kg by intraperitoneal injection, and the drug was administered once every other day; the blank control group and the model group mice were gavaged with an equal amount of drinking water every day.

[0057] Example 6: Study on tumor inhibition efficacy During the administration period, the long and short diameters (mm) of the subcutaneous transplanted tumors were accurately measured with a vernier caliper every two days, and the tumor volume (mm) was calculated according to the formula 3 ) = 1 / 2 × major diameter × minor diameter 2 Calculate the volume of the subcutaneous transplanted tumor. After the administration, the mice were killed, the subcutaneous tumors were removed and weighed, and the tumor inhibition rate was calculated from the tumor volume and tumor weight. The calculation formula is as follows: Tumor inhibition rate (tumor volume, %) = (1 ~ average tumor volume of the experimental group / average tumor volume of the model group) × 100%; Tumor inhibition rate (tumor mass, %) = (1 ~ average tumor mass of the experimental group / average tumor mass of the model group) × 100%. From Figure 1 From the tumor growth curve and the calculation results of the tumor inhibition rate of each medication group in Table 1, it can be seen that each Chinese medicine combination treatment group has a good inhibitory effect on tumors, among which the tumor inhibition rate of Chinese medicine three treatment group reached more than 70%, with the best effect.

[0058] Table 1 and Table 2 show the effect of the Chinese medicine composition of the present invention on the tumor inhibition rate of Lewis lung cancer mice in Example 6 of the present invention. Figure 1Statistical symbols: ****p<0.0001, ***p<0.001, **p<0.01, comparison between drug-treated group and model group (M).

[0059]

[0060] Example 7: Study on the effect of Lewis lung cancer on body weight of mice. The body weight of mice was measured and recorded every 2 days during the administration period. The body weight curve was drawn as follows: Figure 2 As shown. During the experiment, the weight of mice in each group treated with the Chinese medicine composition remained relatively stable, while the weight of mice in the positive control cisplatin group decreased significantly. This shows that mice have good compliance with the Chinese medicine composition and it has good safety at the dosage.

[0061] Example 8: Comparison of the number of dendritic cells in mouse tumor microenvironment. The tumor tissue was minced into 2-3 mm pieces, digested with DMEM medium containing type IV collagenase, hyaluronic acid, and DNase on a shaker at 37°C for 30 min, vortexed and dispersed, and filtered through a 70um filter. Centrifuged, the supernatant was discarded, CD16 / CD32 was added for blocking for 5 min, and then flow antibody staining was performed, washed with PBS and resuspended, and tested on a machine. The cell percentage was analyzed using Novoexpress. The results are shown in Figure 3 As shown, after the Chinese medicine compositions of Examples 1, 2, and 3 were administered to tumor-bearing mice, the CD11b + CD80 + DCs, CD11b + CD86 + DCs, CD11b + MHCII + The number of DCs increased significantly compared with the model group. Mature dendritic cells highly expressed MHC class II molecules and co-stimulatory molecules such as CD80 and CD86, had strong antigen presentation capabilities, and stimulated cellular immune responses. It can be seen that the Chinese medicine composition can promote the phenotypic and functional maturation of dendritic cells and the immune activation function in the tumor microenvironment.

[0062] Example 9: Comparison of the number of tumor-associated macrophages (TAMs) in the mouse tumor microenvironment. The method was the same as above. The results are as follows: Figure 4 As shown, after the Chinese medicine compositions of Examples 1, 2, and 3 were administered to tumor-bearing mice, the proportion of M1 cells in the tumor increased and the proportion of M2 cells decreased compared with the model group. M1 macrophages have tumor cell toxicity in tumor tissues and can effectively present antigens and promote anti-tumor immune responses; M2 macrophages, on the contrary, are considered to have tumor-promoting effects. It can be seen that the Chinese medicine composition can effectively regulate the polarization of M1 and M2 macrophages in the tumor microenvironment, thereby exerting anti-tumor functions.

[0063] Example 10: Comparison of the number of granulocyte-derived MDSCs (PMN-MDSCs) in the mouse tumor microenvironment. The method was the same as above. The results are shown in Figure 5 As shown, after the Chinese medicine compositions of Examples 1, 2, and 3 were administered to tumor-bearing mice, the proportion of PMN-MDSC cells in the tumor decreased compared with the model group. MDSC plays a key role in tumor progression, poor prognosis, and reduced effectiveness of immunotherapy strategies. Among them, in tumor tissue, PMN-MDSC is considered to be the main subpopulation that promotes tumor development. It can be seen that this Chinese medicine composition can effectively regulate the PMN-MDSC cell subpopulation in the tumor microenvironment, thereby exerting anti-tumor function.

[0064] Embodiment 11:

[0065] Comparison of the number of T cells in mouse spleen. The spleen of tumor-bearing mice was removed under sterile conditions, the spleen capsule was torn off, and the spleen was cut into small pieces with ophthalmic scissors. The pieces were placed in PBS buffer, and the spleen was ground and filtered through a tissue grinder and a 200-mesh filter. The pieces were blown evenly to prepare a single-cell suspension. Centrifugation was performed, the supernatant was removed, and 10 times the volume of the cell pellet was added with red blood cell lysis buffer. The red blood cells were lysed at room temperature and away from light for 5 minutes, washed and resuspended with PBS, and CD16 / CD32 was added for blocking for 5 minutes. Flow cytometry antibody staining was performed, the pieces were washed and resuspended with PBS, and the pieces were tested on the machine. The cell percentage was analyzed using Novoexpress. The results are as follows. Figure 6 As shown, after the Chinese medicine compositions of Examples 1, 2, and 3 were administered to tumor-bearing mice, the spleen CD4 + With CD8 + The number of T cells increased significantly compared with the model group. T lymphocytes play an important role in inhibiting the growth of tumor cells and killing tumor cells in the body's anti-tumor process. It can be seen that the Chinese medicine composition can enhance the killing function of T cells and play an anti-tumor effect.

[0066] It should be noted that the above examples are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention is described in detail with reference to the given examples, it is possible for a person skilled in the art to correct or supplement the technical solution of the present invention as needed, and these corrections or supplements should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lung cancer, which is prepared from the following raw materials in parts by weight: 10-20% red ginseng, 10-20% northern adenophora, 10-20% arisaema, 10-40% coix seed, 5-10% gecko, 5-10% toad skin, 10-20% solanum nigrum, and 10-20% thunbergii bulb.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20% red ginseng, 10-20% northern adenophora, 10-15% arisaema, 15-25% coix seed, 5-10% gecko, 5-10% toad skin, 10-20% solanum nigrum, and 15-20% thunbergii bulb.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following components in parts by weight: 11.5% red ginseng, 11.5% northern adenophora, 11.5% arisaema, 22.9% coix seed, 4.6% gecko, 7.6% toad skin, 15.3% solanum nigrum and 15.3% thunbergii bulb.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition also contains a conventional pharmaceutically acceptable carrier.

5. The Chinese medicine composition according to claim 3, characterized in that: The conventional pharmaceutical carriers include emulsifiers, fillers, binders, wetting agents, disintegrants, absorption promoters, flavoring agents, colorants, and solubilizers.

6. The Chinese medicine composition according to claim 1, characterized in that: The dosage form of the Chinese medicine composition is decoction, pill, tablet, mixture, capsule, granule, powder, paste or wine.

7. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicine for treating lung cancer.