Application of traditional Chinese medicine compound decoction in treatment of non-small cell lung cancer

Abstract

The invention discloses an application of a traditional Chinese medicine compound decoction in treatment of non-small cell lung cancer in the technical field of medicines, effective components of the traditional Chinese medicine compound decoction can inhibit proliferation and migration of non-small cell lung cancer cells, induce cell apoptosis and S-phase arrest of a cell cycle, inhibit activation of an IL-6 / AKT signal channel, inhibit apoptosis of the cells and inhibit apoptosis of the cells. Meanwhile, Ki-67 protein expression can be down-regulated to inhibit cell proliferation, the response not only can directly inhibit tumor cell proliferation and promote apoptosis in curative effect, but also can obviously enhance the sensitivity of the existing chemotherapeutic drugs, and has a unique protective effect of preventing or reducing liver and kidney toxicity caused by chemotherapy, so that the synergistic treatment purpose of reducing toxicity and improving efficiency is achieved.

Description

Technical Field

[0001] This invention belongs to the field of medical technology, specifically the application of a traditional Chinese medicine compound decoction in the treatment of non-small cell lung cancer. Background Technology

[0002] Lung cancer has become the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 80% of all lung cancers. Since over 75% of patients are diagnosed at an advanced stage, missing the opportunity for radical surgical treatment, current platinum-based chemotherapy, radiotherapy, immune checkpoint inhibitors, and targeted therapy, while prolonging progression-free survival, still result in an overall five-year survival rate of less than 20%. Furthermore, these treatments are accompanied by significant bone marrow suppression, gastrointestinal reactions, immune-related adverse events, and acquired drug resistance, severely impacting patient adherence and quality of life.

[0003] Although traditional Chinese medicine (TCM) does not have a specific disease name, "lung cancer," its symptoms such as cough, hemoptysis, chest pain, and shortness of breath often fall under the categories of "lung accumulation" and "abdominal distension," with the pathogenesis generally being a combination of deficiency and excess. Modern TCM believes that deficiency of vital energy (Qi) is the intrinsic basis for tumor development, allowing pathogenic factors to invade the lungs, leading to Qi stagnation, blood stasis, phlegm accumulation, and toxin buildup, eventually forming masses. Therefore, treatment focuses on "strengthening the body's resistance and eliminating pathogenic factors," emphasizing tonifying Qi and nourishing Yin, clearing heat and detoxifying, resolving phlegm and dissipating masses, and promoting blood circulation and removing blood stasis. In recent years, TCM compound formulas, due to their advantages of multiple components, multiple targets, multiple pathways, and overall regulation, have shown unique value in improving symptoms, enhancing immune function, prolonging survival, and reducing the toxic side effects of radiotherapy and chemotherapy in NSCLC patients, attracting widespread attention.

[0004] With advancements in analytical techniques, research on the pharmacodynamic material basis of traditional Chinese medicine (TCM) compound formulas for NSCLC treatment has shifted from empirical compatibility studies to modern scientific explanations encompassing components, targets, pathways, and effects. The combination of network pharmacology with techniques such as UHPLC-MS / MS, molecular docking, gene chips, and molecular dynamics simulations allows researchers to reveal, at a holistic level, the synergistic regulatory effects of active substances in the compound formulas, including flavonoids, saponins, alkaloids, and polysaccharides, on key signaling pathways such as PI3K-Akt, p53, RAS-RAF-MEK-ERK, HIF-1, and mTOR. Furthermore, representative components such as tetrandrine, matrine, astragaloside A, tanshinone, and turmeric alcohol have been found to inhibit NSCLC cell proliferation and metastasis through mechanisms such as inducing apoptosis, ferroptosis, autophagy, and cell cycle arrest. For example, Qingfei Heji induces apoptosis through the PI3K-Akt / p53 pathway, and tetrandrine has been identified as the key active ingredient; Fuzheng Yiliu Fang predicts the "drug-component-target-disease" association through network pharmacology, and experiments have confirmed that it can significantly inhibit tumor growth; other studies have confirmed that Yangyin Jiedu Tang can block the cell cycle and induce cell senescence.

[0005] However, existing patents and literature mostly focus on single-herb active components or fixed-combination granule / capsule preparations, with insufficient attention paid to decoctions, which best conform to traditional Chinese medicine, best reflect the dynamic decoction process of compound prescriptions, and are conducive to the dissolution and synergy of active ingredients; moreover, most compound prescriptions lack systematic research combining modern pharmacodynamic material basis and TCM syndrome characteristics, resulting in vague clinical positioning and difficulty in meeting the needs of precision treatment.

[0006] Therefore, targeting the core syndrome of NSCLC characterized by deficiency of both Qi and Yin and mutual accumulation of toxins and blood stasis, and focusing on the treatment principle of "tonifying Qi and nourishing Yin, detoxifying and dispersing nodules," this study selects classic prescriptions that have been repeatedly verified to be effective in clinical practice and have relatively clear material basis. It adopts the traditional decoction form and further elucidates its active component groups, key target network, and mechanisms of synergistic effect and toxicity reduction. This is of great significance for filling the gap in the field, promoting the modernization of traditional Chinese medicine compound prescriptions, and providing safe and effective new treatment strategies for patients with advanced NSCLC. Summary of the Invention

[0007] To address the aforementioned problems, the purpose of this invention is to provide an application of a traditional Chinese medicine compound decoction in the treatment of non-small cell lung cancer. This involves scientifically combining a principal herb (strengthening the spleen and replenishing qi, supporting the body's resistance) with an assistant herb (resolving phlegm and dissipating nodules, detoxifying), and supplementing with herbs that dry dampness, resolve phlegm, and promote blood circulation to harmonize the various herbs, ultimately forming a multi-component, multi-target, and multi-pathway synergistic treatment regimen. This application not only directly inhibits tumor cell proliferation and promotes apoptosis but also significantly enhances the sensitivity to existing chemotherapy drugs and uniquely possesses a protective effect against or reduces chemotherapy-induced liver and kidney toxicity, thereby achieving a synergistic therapeutic goal of "reducing toxicity and increasing efficacy."

[0008] To achieve the above objectives, the technical solution of the present invention is as follows: The application of a traditional Chinese medicine compound decoction in the treatment of non-small cell lung cancer, wherein the traditional Chinese medicine compound decoction is made from raw materials comprising the following parts by weight:

[0009] Astragalus membranaceus 15-30 parts, Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-15 parts, Scutellaria barbata 15-30 parts, Hedyotis diffusa 20-40 parts, Solanum nigrum 10-20 parts, Pinellia ternata 6-12 parts, Solanum lyratum 10-15 parts, Poria cocos 10-20 parts, Citrus reticulata 6-12 parts, Coix lacryma-jobi 15-30 parts, Massa fermentata 10-20 parts, Hordeum vulgare 10-20 parts, Platycodon grandiflorus 6-12 parts, Epimedium brevicornu 10-15 parts, and Glycyrrhiza uralensis 3-9 parts.

[0010] Furthermore, the traditional Chinese medicine compound decoction is made from raw materials comprising the following parts by weight:

[0011] Astragalus membranaceus 25 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 12 parts, Scutellaria barbata 25 parts, Hedyotis diffusa 30 parts, Solanum nigrum 15 parts, Pinellia ternata 9 parts, Solanum lyratum 12 parts, Poria cocos 15 parts, Citrus reticulata 9 parts, Coix lacryma-jobi 25 parts, Massa fermentata 15 parts, Hordeum vulgare 15 parts, Platycodon grandiflorus 9 parts, Epimedium brevicornu 12 parts, Glycyrrhiza uralensis 6 parts.

[0012] Furthermore, the effective components of the traditional Chinese medicine compound decoction include one or more of the following: kaempferol, quercetin, naringenin, isoliquiritigenin, luteolin, physostigmine, β-sitosterol, stigmasterol, and sennasterol.

[0013] The basic principle of the formula is as follows: Astragalus membranaceus, Codonopsis pilosula, and Atractylodes macrocephala are the principal herbs in the formula, which invigorate qi and strengthen the spleen, rebuilding the spleen and stomach's digestive function and ensuring that "when the body's vital energy is abundant, pathogens cannot invade." This enhances Th1-type cellular immunity by upregulating T-bet / STAT1 signaling and activating the AMPK / mTOR pathway to induce tumor autophagy. Scutellaria barbata, Hedyotis diffusa, Solanum nigrum, and Solanum lyratum are the secondary herbs, which clear heat and detoxify. Their rich flavonoid groups, such as kaempferol, quercetin, and naringenin, can directly inhibit the EGFR / PI3K / Akt / NF-κB axis, downregulate Bcl-2, and upregulate Bax and Caspas. e-3 expression promotes tumor cell apoptosis while inhibiting VEGF secretion and blocking tumor angiogenesis. Pinellia ternata, Poria cocos, Citrus reticulata peel, and Coix lacryma-jobi are used as adjuvants to dry dampness, resolve phlegm, regulate qi, and harmonize the middle jiao, reducing the levels of inflammatory factors such as IL-6 and TNF-α in the microenvironment, reversing M2 polarization of tumor-associated macrophages, and synergistically blocking STAT3 signal-driven invasion and metastasis. Massa fermentata, Hordeum vulgare, Platycodon grandiflorus, and Epimedium are used as guiding herbs to harmonize the spleen and stomach, raise clear yang, and warm kidney yang, promoting drug absorption and distribution, increasing blood drug concentration, and reducing first-pass metabolism of chemotherapy drugs by regulating the CYP450 enzyme system. After the combination of these herbs, multiple components form a multidimensional network of "immunity-inflammation-metabolism-apoptosis," both supporting the body's resistance and eliminating pathogenic factors, inhibiting tumor proliferation and reversing drug resistance, achieving overall synergistic effects of the compound.

[0014] The beneficial effects of the basic regimen are: 1. By synergistically blocking key signals of tumor proliferation through multiple components, it induces programmed cell death in cancer cells, thereby significantly slowing down or stabilizing lesion progression.

[0015] 2. Activate the anti-tumor activity of the body's T cells and macrophages, rebuild immune surveillance, and improve the patient's own defense capabilities.

[0016] 3. Relieves tumor-related symptoms such as fatigue, loss of appetite, cough, and shortness of breath, and improves physical condition and quality of life.

[0017] 4. Regulates the spleen and stomach's digestive function, improves intestinal flora imbalance, and reduces the incidence of chemotherapy-related diarrhea or constipation.

[0018] 5. Inhibits the release of pro-inflammatory factors in the tumor microenvironment, reducing local and systemic chronic inflammatory responses.

[0019] 6. By inhibiting angiogenesis and epithelial-mesenchymal transition, it reduces the risk of recurrence and distant metastasis after surgery or radiotherapy and chemotherapy.

[0020] 7. The body tolerates it well, with no significant additional adverse reactions, making it easier for patients to accept long-term combination therapy.

[0021] Furthermore, the traditional Chinese medicine compound decoction is used to prepare a sensitizer that enhances the sensitivity of non-small cell lung cancer to chemotherapy drugs.

[0022] Furthermore, the chemotherapy drug is cisplatin.

[0023] Furthermore, the traditional Chinese medicine compound decoction is used to prepare a protective agent to prevent or reduce liver and kidney toxicity caused by chemotherapy drugs.

[0024] Furthermore, the chemotherapy drug is cisplatin.

[0025] The basic principle of the regimen is as follows: When used in combination with platinum-based chemotherapy regimens, phytosterols such as β-sitosterol and stigmasterol in the formula can insert into the tumor cell membrane, increase membrane fluidity, and promote the transmembrane uptake of drugs such as cisplatin and paclitaxel; flavonoids, by downregulating the expression of DNA repair genes such as ERCC1 and BRCA1, block the nucleotide excision repair pathway, thereby significantly reducing the resistance threshold of tumor cells to platinum; at the same time, astragalus polysaccharides and codonopsis saponins synergistically activate the Nrf2 / HO-1 pathway, enhance the body's antioxidant capacity, and reduce cisplatin-induced ROS burst; glycyrrhizic acid and glycyrrhetinic acid, by inhibiting NF-κB and TGF-β / Smad signaling, reduce inflammation and fibrosis of renal tubular epithelial cells and block chemotherapy-induced nephrotoxicity; atractylodes lactone I and solanine, by inhibiting CYP2E1 and upregulating GSH-Px and SOD activities, reduce hepatic lipid peroxidation and protect hepatocyte mitochondrial function, thereby preventing or significantly reducing chemotherapy-induced liver and kidney damage.

[0026] The beneficial effects of the basic regimen are: 1. It increases the sensitivity of tumor cells to conventional chemotherapy drugs, reduces the incidence of drug resistance, and significantly improves the efficacy of chemotherapy regimens with the same dosage.

[0027] 2. Protect liver and kidney function, reduce transaminase elevation and renal tubular damage caused by drugs such as cisplatin, maintain stable liver and kidney function, reduce abnormal elevation of transaminase and serum creatinine, and avoid dose-limiting toxicity.

[0028] 3. While enhancing the efficacy of cisplatin, reducing its dose-limiting toxic side effects provides a feasible way to improve the safety window of medication in clinical practice.

[0029] 4. By strengthening the body's resistance and consolidating its foundation, it enhances the body's cellular immune response, improves the immunosuppressive state after chemotherapy, and further consolidates the anti-tumor effect of cisplatin.

[0030] Furthermore, the mechanism of action of the drug includes inhibiting the proliferation and / or migration of non-small cell lung cancer cells.

[0031] The beneficial effects of the basic protocol are: 1. By blocking key nodes of the cell cycle through multiple targets, it significantly inhibits the continuous division and clonal expansion of non-small cell lung cancer cells.

[0032] 2. Downregulate the expression of epithelial-mesenchymal transition-related proteins, reduce cell invasion and distant metastasis, and decrease the risk of dissemination after surgery or chemotherapy.

[0033] 3. While inhibiting proliferation and migration, it increases the efficiency of cisplatin entering tumor cells, further amplifying the cytotoxic effect of chemotherapy drugs.

[0034] Furthermore, the mechanism of action of the drug includes inducing apoptosis and / or S-phase arrest of non-small cell lung cancer cells.

[0035] The beneficial effects of the basic regimen are: 1. By activating mitochondrial-dependent and death receptor pathways, it induces programmed cell death in non-small cell lung cancer cells, accelerating lesion shrinkage and stabilization.

[0036] 2. Synchronously arresting tumor cells during the DNA synthesis phase increases the efficiency of cisplatin-DNA adduct formation and significantly improves chemosensitivity.

[0037] 3. While enhancing apoptosis and cell cycle arrest in cancer cells, it protects normal liver and kidney cells from the adverse effects of cisplatin toxicity, achieving "high efficiency and low toxicity".

[0038] 4. By intervening in both apoptosis and cell cycle, we can reduce adaptive mutations in surviving tumor cell subsets and decrease the probability of acquired drug resistance.

[0039] Furthermore, the induction of apoptosis is associated with the upregulation of Caspase-3 protein expression; the inhibition of cell proliferation is associated with the downregulation of Ki-67 protein expression.

[0040] The beneficial effects of the basic regimen are: 1. By upregulating the expression of Caspase-3 protein, it strengthens the tumor cell apoptosis signaling cascade, prompts non-small cell lung cancer cells to rapidly and irreversibly enter programmed cell death, and significantly reduces the tumor burden.

[0041] 2. Downregulating Ki-67 protein expression effectively inhibits the proliferation of tumor cells, blocks their continuous division and clonal expansion, and delays lesion progression.

[0042] 3. The above mechanism, in synergy with cisplatin, can further amplify the apoptosis effect induced by chemotherapy drugs and reduce the liver and kidney toxicity caused by cisplatin, achieving the combined therapeutic advantage of "reducing toxicity and increasing efficacy".

[0043] Furthermore, the mechanism of action of the drug includes inhibiting the activation of the IL-6 / AKT signaling pathway.

[0044] The beneficial effects of the basic regimen are: 1. By blocking the IL-6 / AKT signaling pathway, it significantly inhibits the survival and proliferation of non-small cell lung cancer cells and reduces the tumor burden.

[0045] 2. It weakens the IL-6-mediated inflammatory microenvironment, inhibits cancer cell migration and invasion, and reduces the risk of metastasis.

[0046] 3. Inhibits excessive AKT activation, reverses cisplatin resistance, and improves chemosensitivity.

[0047] 4. Reduces IL-6 / AKT pathway-induced oxidative stress and inflammatory response, protects liver and kidney function, and reduces cisplatin-related toxicity.

[0048] Furthermore, the drug is an oral preparation, preferably a decoction, granules, tablets, or capsules.

[0049] Furthermore, the traditional Chinese medicine compound decoction is used in combination with the chemotherapy drugs to achieve synergistic treatment, reduce toxicity and enhance efficacy.

[0050] The benefits of the basic regimen are: 1. It is available in various oral formulations such as decoction, granules, tablets or capsules, which are convenient for patients to take for a long time and have good compliance.

[0051] 2. When used in combination with cisplatin, it significantly enhances the antitumor activity of chemotherapy drugs against non-small cell lung cancer through multiple target mechanisms such as inhibiting the IL-6 / AKT signaling pathway, upregulating Caspase-3, and downregulating Ki-67.

[0052] 3. Effectively blocks cisplatin-induced oxidative stress and inflammatory response, reduces liver and kidney toxicity, and ensures the smooth completion of chemotherapy.

[0053] 4. While maintaining high efficacy in fighting tumors, it reduces common side effects such as bone marrow suppression and gastrointestinal reactions, thereby improving patients' quality of life and tolerance. Attached Figure Description

[0054] Figure 1 This is an intersection diagram of the targets of traditional Chinese medicine compound ingredients and NSCLC targets (Note: the green part represents the targets of traditional Chinese medicine compound decoctions; the blue part represents the targets of non-small cell lung cancer).

[0055] Figure 2 To construct the core target protein interaction network.

[0056] Figure 3 GO analysis of the interaction targets between traditional Chinese medicine compound and NSCLC (Note: BP: biological process; CC: cellular component; MF: molecular function).

[0057] Figure 4 KEGG analysis of the interaction targets between traditional Chinese medicine compound and NSCLC.

[0058] Figure 5 This shows the docking of sitosterol, stigmasterol, β-sitosterol, and spinasterol with the target protein AKT-1.

[0059] Figure 6 The effects of traditional Chinese medicine compound on the proliferation of A549 and H460 cells were investigated using the CCK8 assay, EdU cell proliferation assay, and LDH assay (Note: * represents P < 0.05, ** represents P < 0.01, *** represents P < 0.00).

[0060] Figure 7 The effect of different drug treatments on cell apoptosis was detected by bright-field microscopy and TUNEL assay (×10).

[0061] Figure 8 To detect the effects of different drug treatments on cell cycle and apoptosis using flow cytometry.

[0062] Figure 9 The data show the body weight and liver and kidney parameters of the nude mice in each group during the nude mouse experiment. Detailed Implementation

[0063] The following detailed description illustrates the specific implementation method:

[0064] Example 1

[0065] The application of a traditional Chinese medicine compound decoction in the treatment of non-small cell lung cancer, wherein the traditional Chinese medicine compound decoction is made from raw materials comprising the following parts by weight:

[0066] Astragalus membranaceus 15-30 parts, Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-15 parts, Scutellaria barbata 15-30 parts, Hedyotis diffusa 20-40 parts, Solanum nigrum 10-20 parts, Pinellia ternata 6-12 parts, Solanum lyratum 10-15 parts, Poria cocos 10-20 parts, Citrus reticulata 6-12 parts, Coix lacryma-jobi 15-30 parts, Massa fermentata 10-20 parts, Hordeum vulgare 10-20 parts, Platycodon grandiflorus 6-12 parts, Epimedium brevicornu 10-15 parts, and Glycyrrhiza uralensis 3-9 parts.

[0067] The specific implementation process is as follows: The traditional Chinese medicine compound decoction of this invention strictly follows the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine. Its pharmacological effect is not a simple superposition of single medicinal materials, but a synergistic effect produced by organic combination.

[0068] The principal drug group aims to protect the body's fundamental health, enhance its resistance, and provide a foundation for treatment.

[0069] Astragalus: Sweet and warm in nature, it enters the spleen and lung meridians. It is an essential herb for tonifying qi. Modern pharmacology shows that astragalus polysaccharides and astragaloside can significantly enhance the body's immune function, promote lymphocyte transformation, and enhance the activity of natural killer cells (NK) and macrophages, thereby regulating the immunosuppressive state in the tumor microenvironment. It can also reduce the toxic side effects of radiotherapy and chemotherapy and protect hematopoietic function. Codonopsis: Sweet and neutral in nature, it enters the spleen and lung meridians. It excels at tonifying the middle jiao and replenishing qi, strengthening the spleen and benefiting the lungs. Its active ingredient, Codonopsis polysaccharide, can increase superoxide dismutase (SOD) activity, scavenge free radicals, combat fatigue, protect liver and kidney function, and provide an energy basis for the body's anti-tumor struggle. Atractylodes: Bitter, sweet, and warm in nature, it enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis. Atractylodes lactone and other components have the effects of regulating intestinal flora, protecting the gastric mucosa, and improving immunity. Its spleen-strengthening effect, combined with that of astragalus and Codonopsis, strengthens the acquired constitution and improves common spleen deficiency symptoms such as fatigue and poor appetite in cancer patients.

[0070] The herbal formula is the main force that directly targets the pathogenic factors of "phlegm toxins" and exerts its anti-cancer effect.

[0071] *Scutellaria barbata*: Pungent, bitter, and cold in nature, it enters the lung, liver, and kidney meridians. It clears heat and detoxifies, resolves blood stasis, and promotes diuresis. It is a recognized anti-cancer Chinese medicine; its flavonoids and polysaccharides can directly inhibit the proliferation of various cancer cells (such as A549 and H460), induce apoptosis and cell cycle arrest, and inhibit tumor angiogenesis. *Hedyotis diffusa*: Sweet, bland, and cool in nature, it enters the stomach, large intestine, and small intestine meridians. It clears heat and detoxifies, promotes diuresis, and relieves strangury. Its main components, cypermethrin and anthraquinone compounds, have broad anti-tumor activity, inhibiting tumor growth by regulating multiple signaling pathways (such as PI3K / Akt), and forming a well-known anti-cancer drug pair with *Scutellaria barbata*, synergistically enhancing their effects. *Solanum nigrum*: Bitter, cold, and slightly toxic in nature, it enters the lung and bladder meridians. It clears heat and detoxifies, invigorates blood, and reduces swelling. Solanine and other alkaloids are key components of its anti-tumor activity, inducing tumor cell apoptosis by disrupting mitochondrial function and producing reactive oxygen species (ROS). Pinellia ternata: Pungent, warm, and toxic in nature; enters the spleen, stomach, and lung meridians. It dries dampness and resolves phlegm, relieves nausea and vomiting, and dissipates lumps and nodules. Its alkaloids can inhibit tumor cell proliferation and effectively suppress vomiting, alleviating nausea and vomiting caused by chemotherapy. Solanum lyratum: Bitter, slightly cold, and slightly toxic in nature; enters the liver and stomach meridians. It clears heat and detoxifies, promotes diuresis and reduces swelling. Its steroidal saponins have anti-tumor and immunomodulatory effects.

[0072] The adjuvant herbs assist the principal and assistant herbs in exerting their effects, while also regulating the spleen and stomach functions.

[0073] Poria cocos: Sweet, bland, and neutral in nature, it enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Poria cocos polysaccharides are excellent immune enhancers, improving edema and promoting the excretion of metabolic waste. Dried tangerine peel: Bitter, pungent, and warm in nature, it enters the lung and spleen meridians. It regulates qi, strengthens the spleen, dries dampness, and resolves phlegm. Its volatile oils promote the secretion of digestive juices, enhance gastrointestinal motility, and relieve abdominal distension. Coix seed: Sweet, bland, and cool in nature, it enters the spleen, stomach, and lung meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, stops diarrhea, clears heat, and drains pus. Coix seed oil has been proven to inhibit cancer cell proliferation and induce differentiation and apoptosis, especially beneficial for lung cancer. Shenqu (medicated leaven) and malt: Both are sweet and warm in nature, entering the spleen and stomach meridians. They function to aid digestion and harmonize the stomach, strengthen the spleen, and stimulate appetite. Rich in digestive enzymes and vitamins, they can effectively improve loss of appetite and indigestion in cancer patients caused by disease and treatment, ensuring the absorption of drugs and nutrients.

[0074] This allows the medicine to guide its effects to the affected area and harmonizes the overall properties of the prescription.

[0075] Platycodon grandiflorus: Bitter, pungent, and neutral in nature, it enters the Lung meridian. It clears the lungs, benefits the throat, eliminates phlegm, and drains pus. As a "carrier," it guides other herbs upwards to the affected area of ​​the Lung meridian. Its saponin components also promote respiratory secretions, dilute phlegm, and facilitate its expulsion. Epimedium: Pungent, sweet, and warm in nature, it enters the Liver and Kidney meridians. It tonifies Kidney Yang and strengthens tendons and bones. Epimedium glycosides can bidirectionally regulate immunity and, to some extent, reverse multidrug resistance in tumors, enhancing the sensitivity to chemotherapy drugs. Glycyrrhiza uralensis: Sweet and neutral in nature, it enters the Heart, Lung, Spleen, and Stomach meridians. It tonifies the Spleen and benefits Qi, clears heat and detoxifies, eliminates phlegm and relieves cough, alleviates spasms and pain, and harmonizes other herbs. Glycyrrhizic acid and glycyrrhetinic acid have anti-inflammatory, hepatoprotective, and detoxifying effects, mitigating the toxicity and severity of other drugs, especially protecting the liver from chemotherapy drug damage.

[0076] The comprehensive therapeutic effect of this compound formula embodies the essence of traditional Chinese medicine's "holistic view" and "treatment based on syndrome differentiation".

[0077] The formula contains Astragalus membranaceus, Codonopsis pilosula, and Atractylodes macrocephala to strengthen the body's resistance and improve the patient's immunity and quality of life; and Scutellaria barbata and Hedyotis diffusa to detoxify and directly inhibit tumors. These two ingredients complement each other, avoiding the drawbacks of either "attacking without tonifying" which depletes the body's vital energy or "tonifying without attacking" which appeases the tumor. This compound works synergistically through multiple mechanisms: direct cytotoxic effects (inducing apoptosis and cell cycle arrest), immune regulation (enhancing NK cell and macrophage function), inhibition of angiogenesis, reversal of multidrug resistance, and regulation of the tumor microenvironment (inhibiting the IL-6 / AKT inflammatory pathway), forming a comprehensive treatment network targeting multiple targets. The most distinctive value of this formula lies in its "toxicity-reducing and efficacy-enhancing" effect when used in combination with chemotherapy drugs (such as cisplatin). The "enhancing effect" is reflected in the fact that ingredients such as Epimedium can sensitize chemotherapy; the "reducing toxicity" is reflected in the fact that licorice, Poria, and Atractylodes macrocephala can significantly protect liver and kidney function, reduce the nephrotoxicity and digestive system reactions of cisplatin, and medicated leaven and malt improve appetite, thereby ensuring the smooth completion of chemotherapy courses and improving patients' survival and quality of life. The formula covers a variety of treatment methods, including regulating qi (tangerine peel), resolving phlegm (Pinellia ternata and Poria), removing dampness (Coix seed), and promoting digestion (medicated leaven and malt), comprehensively improving common systemic symptoms in cancer patients such as phlegm-dampness, qi stagnation, and poor appetite, and restoring the body's balance.

[0078] Example 2

[0079] The difference from the above embodiments is that, as Figures 1 to 5 As shown, the traditional Chinese medicine compound decoction is made from raw materials comprising the following parts by weight:

[0080] Astragalus membranaceus 25 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 12 parts, Scutellaria barbata 25 parts, Hedyotis diffusa 30 parts, Solanum nigrum 15 parts, Pinellia ternata 9 parts, Solanum lyratum 12 parts, Poria cocos 15 parts, Citrus reticulata 9 parts, Coix lacryma-jobi 25 parts, Massa fermentata 15 parts, Hordeum vulgare 15 parts, Platycodon grandiflorus 9 parts, Epimedium brevicornu 12 parts, Glycyrrhiza uralensis 6 parts.

[0081] The effective components of traditional Chinese medicine compound decoctions include one or more of the following: kaempferol, quercetin, naringenin, isoliquiritigenin, luteolin, physostigmine, β-sitosterol, stigmasterol, and sennasterol.

[0082] The drug is an oral preparation, preferably a decoction, granules, tablets or capsules.

[0083] The specific implementation process is as follows: In order to explore the biological mechanism of traditional Chinese medicine compound treatment for advanced NSCLC, the main effective components of traditional Chinese medicine compound were analyzed and identified based on network pharmacology and HPLC-Q-TOF-MS / MS technology.

[0084] I. Network Pharmacological Analysis

[0085] 1. Screening of target points for traditional Chinese medicine compound decoctions

[0086] A total of 298 effective components from 16 Chinese herbal medicines in the compound were obtained, and after deduplication, 1141 effective targets were identified, as detailed in Table 1.

[0087] Table 1. Information on active ingredients in traditional Chinese medicine compound prescriptions

[0088]

[0089] 2. Network pharmacological analysis of traditional Chinese medicine compound decoctions

[0090] After removing duplicates, the effective component targets of traditional Chinese medicine compound prescriptions totaled 1141, while the disease targets of NSCLC totaled 6513. A Venn diagram was plotted using their intersection targets, combined with... Figure 1 As shown, 610 overlapping targets between the drug and the disease were identified. (Combined with...) Figure 2 As shown, 106 core targets and 3 major targets (TP53, IL6, and AKT1) were screened. Combined with... Figure 3 As shown, the KEGG enrichment analysis results indicate that biological processes (BP) mainly involve protein phosphorylation, protein autophosphorylation, and upregulation of cell proliferation; cell components (CC) mainly include the cell membrane, cytoplasm, and cytosolic fluid; and molecular functions (MF) are related to protein serine / threonine / tyrosine kinase activity, ATP binding, and protein kinase activity. Bubble charts and bar charts were plotted using the top 25 results from the KEGG enrichment analysis. Combined with... Figure 4 As shown, key targets are mainly enriched in cancer pathogenesis pathways, lipids and atherosclerosis, hepatitis B virus, EGFR-TKIs resistance, and HIF-1 signaling pathway.

[0091] The four active ingredients of traditional Chinese medicine compound selected from the PPI network are sitosterol, stigmasterol, beta-sitosterol, and spinasterol. These components dock with target proteins AKT-1, Bcl-2, IL6, TP53, and GAPDH, binding... Figure 5As shown in Table 2, the optimal conformation was selected based on the binding energy and hydrogen bond formation during each docking of the compound with the target protein. Each active ingredient and the AKT-1 active pocket of the target protein showed suitable docking sites and hydrogen bond formation during the docking process. The docking results of four active ingredients with five target proteins are shown in Table 2. The binding energy of all active ingredients with the target proteins was less than 0, indicating that these ingredients can spontaneously dock and establish binding relationships with the receptor proteins. This indicates that the main components of the traditional Chinese medicine compound can bind well to the target proteins AKT-1, Bcl-2, IL6, TP53, and GAPDH. These results suggest that the targets of the traditional Chinese medicine compound in regulating the pathogenesis of lung cancer, predicted using network pharmacology, are reliable. In summary, semperol showed the highest binding affinity to the target proteins, AKT-1 was the strongest binding target among all compounds, and the docking results of semperol with AKT-1 were more ideal, suggesting that it may play an important role in the regulation of the pathogenesis of lung cancer by the traditional Chinese medicine compound.

[0092] Table 2. Docking of sitosterol, stigmasterol, β-sitosterol and spinasterol with target proteins AKT-1, Bcl-2, IL6, TP53 and GAPDH.

[0093]

[0094]

[0095] II. HPLC-Q-TOF-MS / MS technique for analysis and identification of the main effective components of traditional Chinese medicine compound decoctions

[0096] By combining the retention time of reference standards, quasi-molecular ions, secondary mass spectrometry fragment information comparison, MassHunter PCDLManager (version B.08.00) database comparison, and confirmation from relevant literature, a total of 68 components of traditional Chinese medicine compound were identified, such as: arbutin, luteolin, isoliquiritin, kaempferol, quercetin, naringenin, etc.

[0097] Example 3

[0098] The difference from the above embodiments is that, as Figures 6 to 9 As shown, a traditional Chinese medicine compound decoction is used to prepare a sensitizer that enhances the sensitivity of non-small cell lung cancer to chemotherapy drugs, wherein the chemotherapy drug is cisplatin.

[0099] An application of a traditional Chinese medicine compound decoction for preparing a protective agent to prevent or reduce liver and kidney toxicity caused by chemotherapy drugs, wherein the chemotherapy drug is cisplatin.

[0100] The drug's mechanism of action includes inhibiting the proliferation and / or migration of non-small cell lung cancer cells, inducing apoptosis and / or S-phase arrest of the cell cycle in non-small cell lung cancer cells, wherein the induction of apoptosis is associated with upregulation of Caspase-3 protein expression; the inhibition of cell proliferation is associated with downregulation of Ki-67 protein expression; and the drug's mechanism of action includes inhibiting the activation of the IL-6 / AKT signaling pathway. The traditional Chinese medicine compound decoction is used in combination with the chemotherapy drug to achieve synergistic treatment, reduce toxicity, and enhance efficacy.

[0101] The specific experimental procedure is as follows: I. Experiment on inhibiting NSCLC cells using the above-mentioned compound Chinese medicine decoction.

[0102] The effects of serum containing traditional Chinese medicine compound (traditional Chinese medicine compound decoction) on the proliferation of lung cancer cell lines A549 and H460 were investigated using CCK8 assay, EdU cell proliferation assay and LDH assay.

[0103] 1. Traditional Chinese medicine compound decoctions can effectively inhibit the proliferation of NSCLC cells.

[0104] The results showed that 24 hours after administration, compared with the control group, cisplatin had no significant inhibitory effect on the proliferation of A549 and H460 (P>0.05), and the traditional Chinese medicine compound decoction alone also had no significant inhibitory effect on A549 (P>0.05), while the traditional Chinese medicine compound decoction alone had a significant inhibitory effect on H460 (P<0.05), indicating that H460 is more sensitive to the traditional Chinese medicine compound decoction.

[0105] Furthermore, for both A549 and H460, the combination of traditional Chinese medicine decoction and cisplatin significantly enhanced the inhibitory effect on proliferation (P < 0.05). We further observed the effects of different concentration gradients of traditional Chinese medicine decoction combined with cisplatin on the proliferation of A549 and H460, combined with... Figure 6 The results showed that with increasing drug concentration, the inhibitory effect of the traditional Chinese medicine compound decoction combined with cisplatin on the proliferation of A549 and H460 gradually increased (P<0.05). Except for the traditional Chinese medicine compound decoction combined with cisplatin to intervene in A549 as detected by CCK8 assay, there was no significant difference in the inhibitory effect of different concentrations of traditional Chinese medicine compound decoction combined with chemotherapy (P>0.05). It is considered that low dose of traditional Chinese medicine compound decoction combined with chemotherapy has a strong inhibitory effect and reaches a plateau phase.

[0106] 2. Traditional Chinese medicine compound decoctions can induce apoptosis in NSCLC cells.

[0107] Bright-field microscopy revealed that both traditional Chinese medicine decoctions and cisplatin could cause morphological changes and ghosting of A549 and H460. Figure 7The red arrows indicate that the combination of traditional Chinese medicine (TCM) compound decoction and cisplatin intervention further increased the number of cells with morphological changes, indicating that both TCM compound decoction and cisplatin can induce apoptosis, and the combination of TCM compound decoction and cisplatin intervention can further promote apoptosis. Tunel experiments further confirmed that the TCM compound decoction promoted apoptosis in A549 and H460 cells. Apoptotic cells were labeled with Cy3 fluorescence, appearing red under an inverted fluorescence microscope. The control group showed a lighter red nuclear label and fewer cells. After intervention with cisplatin and the TCM compound decoction respectively, the nuclear label was slightly darker red and more numerous. After combined intervention with cisplatin and the TCM compound decoction, the cell nuclei were round or oval, bright red, and the number of stained nuclei significantly increased. This suggests that the TCM compound decoction can promote apoptosis in A549 and H460 cells.

[0108] To further investigate the effects of traditional Chinese medicine (TCM) compound decoctions on apoptosis in A549 and H460 cells, flow cytometry was used to observe the effects of the drugs on cell cycle and apoptosis rate. Cell cycle results showed that, compared with the control group, after 24 hours of intervention with cisplatin and the TCM compound decoction, respectively, A549 and H460 cell lines were significantly arrested in the S phase (i.e., the DNA synthesis phase). After intervention with cisplatin combined with the TCM compound decoction, the proportion of cells in the S phase further increased, indicating that the TCM compound decoction delayed cell proliferation. Apoptosis results were combined with… Figure 8 As shown, compared with the control group, after 24 hours of intervention with cisplatin and the traditional Chinese medicine compound decoction, the proportions of early and late apoptotic cells in A549 and H460 cell lines, respectively, significantly increased. The combination of the traditional Chinese medicine compound decoction and cisplatin intervention further significantly increased the apoptotic proportions in both A549 and H460 cell lines, indicating that the traditional Chinese medicine compound decoction promotes cell apoptosis. In summary, the traditional Chinese medicine compound decoction may induce apoptosis through cell cycle arrest.

[0109] 3. Traditional Chinese medicine compound decoctions can effectively inhibit the metastasis of NSCLC cells.

[0110] The effects of a traditional Chinese medicine (TCM) compound decoction on the migration of A549 and H460 cell lines were further investigated using the scratch assay. Cell wound healing was observed at 0h, 12h, and 24h. Results showed that at 12h and 24h, compared with the control group, interventions with the TCM compound decoction and cisplatin, respectively, and the combination of the TCM compound decoction and cisplatin significantly inhibited scratch healing in both A549 and H460 cell lines, indicating that the TCM compound decoction can inhibit the migration of A549 and H460 cells.

[0111] II. Animal experiments using the above-mentioned traditional Chinese medicine compound decoction

[0112] 1. Traditional Chinese medicine compound decoctions inhibit subcutaneous tumors in nude mice by inducing apoptosis.

[0113] Compared with the model group, the tumor volume and mass of nude mice in each treatment group were significantly reduced (P<0.05); although the tumor volume and mass of the traditional Chinese medicine compound decoction group were reduced compared with the model group (P<0.05), there was no statistically significant difference compared with the positive drug cisplatin group (P<0.05); the combination of traditional Chinese medicine compound decoction and cisplatin further reduced the tumor weight.

[0114] 2. Preliminary safety evaluation of traditional Chinese medicine compound decoctions

[0115] (1) Rat experiment

[0116] Rats were administered low, medium, and high concentrations of a traditional Chinese medicine (TCM) compound decoction. After preparing serum containing the TCM compound decoction, we conducted a safety assessment on the rats. The survival rate of the rats was 100% during the experiment, and no obvious toxic reactions such as diarrhea or loss of appetite were observed. The body weight of rats in all groups gradually increased over time, and there was no significant statistical difference between the groups (P > 0.05). HE staining of the major organs (heart, liver, spleen, lung, and kidney) in each group showed no obvious morphological changes or lesions in the low, medium, and high dose groups of the TCM compound decoction. Biochemical tests indicated no abnormalities in liver and kidney indicators in the low, medium, and high dose groups of the TCM compound decoction. This indicates that the TCM compound decoction has good biocompatibility.

[0117] (2) Nude mouse experiment

[0118] During the nude mouse experiment, we also conducted a safety assessment of the traditional Chinese medicine compound decoction. The survival rate of the nude mice was 100% during the experiment, and no obvious toxic reactions such as diarrhea or loss of appetite were observed. Except for the chemotherapy group, where the body weight of the nude mice did not change significantly, the body weight of the nude mice in all other groups gradually increased over time, but there was no statistically significant difference between the groups (P>0.05). Figure 9 As shown in the figure, except for the cisplatin group where renal function indicators Urea and CRE were significantly elevated (P < 0.05), all other groups had normal biochemical tests, suggesting that cisplatin has nephrotoxicity, while the traditional Chinese medicine compound decoction could reverse the kidney damage caused by cisplatin. This indicates that the traditional Chinese medicine compound decoction has good biocompatibility.

[0119] 3. Effects of traditional Chinese medicine compound decoction on the expression of Ki-67 and Caspase 3, apoptosis-related proteins, in nude mouse tumor tissues.

[0120] Caspase3 protein can cleave various intracellular protein substrates, inducing apoptosis, and its expression level can reflect the degree of apoptosis. Ki-67 is a synthetic antigen related to cell proliferation. Studies have shown that inhibiting Ki-67 can promote the initiation of apoptosis mechanisms in cells, effectively curbing their abnormal proliferation. Our results show that a traditional Chinese medicine compound decoction can inhibit Ki-67 protein expression and promote Caspase3 protein expression in nude mouse tumor tissues, indicating that this formula can effectively inhibit lung cancer by suppressing cell proliferation.

[0121] 4. Effects of traditional Chinese medicine compound decoction on the AKT axis of tumor tissue in nude mice

[0122] IL-6, secreted by T cells and macrophages, is a core inflammatory cytokine bridging inflammation and tumors. High expression of IL-6 in tumor tissues is associated with lung cancer progression, treatment resistance, and poor prognosis in lung cancer patients. Studies have reported that IL-6 signaling can activate AKT (also known as proteinase B), and Akt activation can promote cell survival and inhibit apoptosis. The PI3K / Akt pathway is abnormally activated in various tumors, enabling tumor cells to evade apoptosis.

[0123] This study found that the tumor tissue in the model group expressed the strongest IL-6 and AKT. Intervention with the traditional Chinese medicine compound decoction and cisplatin alone could reduce the expression levels of IL-6 and AKT in the transplanted tumor tissue. However, combined intervention with the traditional Chinese medicine compound decoction and cisplatin significantly reduced the expression of IL-6 and AKT, indicating that the traditional Chinese medicine compound decoction may inhibit the malignant biological behavior of tumor cells by suppressing the IL-6 / AKT signaling pathway. However, other mechanisms of action of the traditional Chinese medicine compound decoction in treating lung cancer require further investigation.

[0124] Example 4

[0125] The difference from the above embodiments is that the above-mentioned compound decoction of traditional Chinese medicine was used in a randomized controlled clinical trial for the treatment of non-small cell lung cancer (NSCLC).

[0126] 1. Research Design and Subjects

[0127] A randomized controlled trial protocol was used to evaluate the clinical efficacy of the traditional Chinese medicine compound decoction of this invention in the treatment of non-small cell lung cancer.

[0128] One hundred and fifty patients who met the diagnostic criteria for NSCLC and were treated at the Affiliated Cancer Hospital of Chongqing University between January 2024 and January 2025 were selected. All patients were pathologically diagnosed with stage IIIB–IV non-small cell lung cancer, had a Karnofsky Performance Status (KPS) score ≥60, an expected survival of ≥3 months, and voluntarily signed informed consent forms. They were randomly divided into five groups of 30 patients each: Control Group 1: conventional chemotherapy (cisplatin + pemetrexed); Control Group 2: conventional chemotherapy + traditional Chinese medicine decoction lacking the principal herbs (Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala); Control Group 3: conventional chemotherapy + traditional Chinese medicine decoction lacking the assistant herbs (Scutellaria barbata, Hedyotis diffusa, Solanum nigrum); Control Group 4: conventional chemotherapy + traditional Chinese medicine decoction lacking the adjuvant herbs (Citrus reticulata peel, Poria cocos, Glycyrrhiza uralensis); Experimental Group: conventional chemotherapy + a complete traditional Chinese medicine compound decoction (prepared according to the formula in Example 1). There were no statistically significant differences in baseline data such as age, sex, pathological type, and TNM stage among the five groups of patients (P>0.05), making them comparable.

[0129] 2. Intervention methods

[0130] Experimental group: Oral administration of the traditional Chinese medicine compound decoction of this invention (100mL twice daily), combined with conventional chemotherapy (cisplatin 75mg / mL). 2 +Pemetrexed 500mg / m 2 (One cycle every 3 weeks); Control group 1: received only conventional chemotherapy; Control groups 2, 3, and 4: received a partial prescription lacking the corresponding components plus conventional chemotherapy.

[0131] The treatment cycle consists of 6 cycles (18 weeks), with efficacy and safety assessed every 3 weeks during the treatment period.

[0132] 3. Evaluation Indicators

[0133] Primary efficacy endpoints: Objective response rate (ORR), progression-free survival (PFS)

[0134] Secondary efficacy endpoints: Quality of life score (QoL), performance status (KPS score), and incidence of chemotherapy-related liver and kidney toxicity (serum creatinine, blood urea nitrogen, ALT, AST).

[0135] Traditional Chinese Medicine syndrome score: includes items such as cough, chest pain, shortness of breath, fatigue, and poor appetite, with each item scored from 0 to 3 points, for a total score of 0 to 15 points.

[0136] 4. Statistical methods

[0137] Data analysis was performed using SPSS 26.0 software. Quantitative data were expressed as mean ± standard deviation (x ± s), and comparisons between groups were performed using t-tests or ANOVA. Categorical data were expressed as x ± s. 2 Test. P < 0.05 is considered statistically significant.

[0138] 5. Statistical data

[0139] As shown in the table below:

[0140] Table 3. Comparison of Objective Response Rates (ORR) after treatment [n(%)]

[0141]

[0142]

[0143] Note: Compared with control group 1, P < 0.05*

[0144] Table 4. Comparison of progression-free survival (PFS) and quality of life scores (x±s)

[0145]

[0146] Note: Compared with control group 1, P < 0.05*

[0147] Table 5. Comparison of the incidence of chemotherapy-related liver and kidney toxicity in patients [n(%)]

[0148]

[0149] Note: Compared with control group 1, P < 0.05*

[0150] 6. Research Conclusions

[0151] The results of this clinical trial demonstrate that the traditional Chinese medicine compound decoction of this invention, combined with chemotherapy, can significantly improve the objective response rate, prolong progression-free survival, improve quality of life and physical condition in patients with non-small cell lung cancer, and significantly reduce chemotherapy-induced liver and kidney toxicity. The absence of any one of the drug groups (principal, assistant, adjuvant, and guide) leads to a decrease in efficacy, indicating that the compound formula of this invention is rationally formulated, has a significant synergistic effect, and possesses important clinical application value.

[0152] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0153] The above descriptions are merely embodiments of the present invention. Commonly known structures and characteristics are not described in detail here. Those skilled in the art are aware of all common technical knowledge in the field prior to the application date or priority date, are aware of all existing technologies in that field, and have the ability to apply conventional experimental methods prior to that date. Those skilled in the art can, under the guidance of this application, improve and implement this solution in combination with their own capabilities. Some typical known structures or methods should not be obstacles for those skilled in the art to implement this application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the structure of the present invention. These should also be considered within the scope of protection of the present invention, and will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. The application of a traditional Chinese medicine compound decoction in the treatment of non-small cell lung cancer, characterized in that: The traditional Chinese medicine compound decoction is made from raw materials comprising the following parts by weight: Astragalus membranaceus 15-30 parts, Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-15 parts, Scutellaria barbata 15-30 parts, Hedyotis diffusa 20-40 parts, Solanum nigrum 10-20 parts, Pinellia ternata 6-12 parts, Solanum lyratum 10-15 parts, Poria cocos 10-20 parts, Citrus reticulata 6-12 parts, Coix lacryma-jobi 15-30 parts, Massa fermentata 10-20 parts, Hordeum vulgare 10-20 parts, Platycodon grandiflorus 6-12 parts, Epimedium brevicornu 10-15 parts, and Glycyrrhiza uralensis 3-9 parts.

2. The application according to claim 1, characterized in that: The traditional Chinese medicine compound decoction is made from raw materials comprising the following parts by weight: Astragalus membranaceus 25 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 12 parts, Scutellaria barbata 25 parts, Hedyotis diffusa 30 parts, Solanum nigrum 15 parts, Pinellia ternata 9 parts, Solanum lyratum 12 parts, Poria cocos 15 parts, Citrus reticulata 9 parts, Coix lacryma-jobi 25 parts, Massa fermentata 15 parts, Hordeum vulgare 15 parts, Platycodon grandiflorus 9 parts, Epimedium brevicornu 12 parts, Glycyrrhiza uralensis 6 parts.

3. The application according to claim 2, characterized in that: The effective components of traditional Chinese medicine compound decoctions include one or more of the following: kaempferol, quercetin, naringenin, isoliquiritigenin, luteolin, physostigmine, β-sitosterol, stigmasterol, and sennasterol.

4. An application of the traditional Chinese medicine compound decoction as described in claim 1, characterized in that: Used to prepare sensitizers that enhance the sensitivity of non-small cell lung cancer to chemotherapeutic drugs.

5. The application according to claim 4, characterized in that: The chemotherapy drug is cisplatin.

6. An application of the traditional Chinese medicine compound decoction as described in claim 1, characterized in that: Used to prepare protective agents to prevent or reduce liver and kidney toxicity caused by chemotherapy drugs.

7. The application according to claim 6, characterized in that: The chemotherapy drug is cisplatin.

8. The application according to any one of claims 1-7, characterized in that: The drug's mechanism of action includes inhibiting the proliferation and / or migration of non-small cell lung cancer cells.

9. The application according to any one of claims 1-7, characterized in that: The drug's mechanism of action includes inducing apoptosis in non-small cell lung cancer cells and / or arresting the S phase of the cell cycle.

10. The application according to claim 9, characterized in that: The induction of apoptosis is associated with upregulation of Caspase-3 protein expression; the inhibition of cell proliferation is associated with downregulation of Ki-67 protein expression.

11. The application according to any one of claims 1-7, characterized in that: The mechanism of action of the drug includes inhibiting the activation of the IL-6 / AKT signaling pathway.

12. The application according to any one of claims 1-7, characterized in that: The drug is an oral preparation, preferably a decoction, granules, tablets or capsules.

13. The application according to claim 4 or 6, characterized in that: The traditional Chinese medicine compound decoction is used in combination with the chemotherapy drugs to achieve synergistic treatment, reduce toxicity and enhance efficacy.

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