A traditional Chinese medicine composition for treating lung cancer, a medicine, and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating lung cancer, a medicine and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition comprises Bupleurum chinense, Dendrobium, Trichosanthes kirilowii, Fritillaria thunbergii Miq., Smilax riparia, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, oyster shell, stir-fried Perilla frutescens, Platycodon grandiflorum and raw licorice. The composition takes Bupleurum chinense as a monarch drug, takes Dendrobium, Trichosanthes kirilowii, Fritillaria Thunbergii Miq. and Smilax riparia as minister drugs, takes Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia, oyster shell, stir-fried Perilla frutescens and Platycodon grandiflorum as auxiliary drugs, and takes raw licorice as a guide drug. The monarch, minister and auxiliary drugs are combined in a strict manner, and multiple effects of soothing liver and regulating qi, clearing heat and reducing phlegm, softening and resolving, benefiting qi and nourishing yin, and cooling blood and stopping bleeding are considered. The composition not only plays an inhibiting role on lung cancer tumor lesions, but also pays attention to regulating the body function of patients, supports the healthy and expels the evil, and can effectively improve the clinical symptoms of lung cancer patients, improve the quality of life, and prolong the survival period.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, drug, preparation method and application for treating lung cancer. Background Technology

[0002] Lung cancer is a highly prevalent malignant tumor worldwide, ranking first in both incidence and mortality among malignant tumors, seriously threatening human life and health. Currently, clinical treatment for lung cancer mainly involves surgery, radiotherapy and chemotherapy, targeted therapy, and immunotherapy. However, many patients in the middle and late stages lose the opportunity for surgery, and postoperative recurrence and metastasis are common. Radiotherapy and chemotherapy have significant side effects, easily damaging normal tissues and organs such as the gastrointestinal tract and hematopoietic system, leading to decreased patient tolerance and affecting treatment adherence. While targeted therapy and immunotherapy are highly specific, their applicability is limited, and they are prone to drug resistance, resulting in poor long-term efficacy.

[0003] Traditional Chinese medicine (TCM) possesses unique advantages in the treatment of lung cancer. Guided by a holistic approach and centered on syndrome differentiation and treatment, it can effectively alleviate clinical symptoms, reduce the toxic side effects of radiotherapy and chemotherapy, enhance the body's immunity, inhibit tumor progression, and improve patients' quality of life. However, current TCM preparations for lung cancer treatment still suffer from drawbacks such as limited dosage forms, inconsistent quality control standards, unclear mechanisms of action, and insufficient clinical evidence. Therefore, developing a scientifically formulated, effective, and low-side-effect TCM composition tailored to the pathogenesis of lung cancer patients has significant clinical value and application prospects. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition, drug, preparation method, and application for treating lung cancer, thereby solving the problems existing in the prior art. This invention uses Bupleurum as the principal ingredient, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, and Actinidia chinensis root as assistant ingredients, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, raw oyster shell, stir-fried Perilla frutescens seed, and Platycodon grandiflorus as adjuvant ingredients, and raw Glycyrrhiza uralensis as the guiding ingredient to prepare a traditional Chinese medicine composition for treating lung cancer. The combination of principal, assistant, adjuvant, and guiding ingredients is rigorous, taking into account multiple effects such as soothing the liver and regulating qi, clearing heat and resolving phlegm, softening and dispersing masses, tonifying qi and nourishing yin, cooling blood and stopping bleeding. It not only inhibits lung cancer tumor lesions but also focuses on regulating the patient's bodily functions, combining strengthening the body's resistance with eliminating pathogenic factors, effectively improving the clinical symptoms of lung cancer patients, enhancing their quality of life, and prolonging their survival.

[0005] To achieve the above objectives, the present invention provides the following solution: This invention provides a traditional Chinese medicine composition for treating lung cancer, comprising the following raw materials by weight: Bupleurum chinense 10-20 parts, Scutellaria barbata 10-20 parts, Trichosanthes kirilowii 10-30 parts, Fritillaria thunbergii 5-15 parts, Actinidia chinensis root 20-40 parts, Scrophularia ningpoensis 10-30 parts, Astragalus membranaceus 10-30 parts, Agrimonia pilosa 20-40 parts, raw oyster shell 20-40 parts, stir-fried Perilla frutescens seed 10-30 parts, Platycodon grandiflorus 5-15 parts, and raw Glycyrrhiza uralensis 5-15 parts.

[0006] Furthermore, by weight, it includes the following raw materials: Bupleurum 15 parts, Scutellaria barbata 15 parts, Trichosanthes kirilowii 20 parts, Fritillaria thunbergii 10 parts, Actinidia chinensis root 30 parts, Scrophularia ningpoensis 20 parts, Astragalus membranaceus 20 parts, Agrimonia pilosa 30 parts, raw oyster shell 30 parts, stir-fried Perilla frutescens seed 20 parts, Platycodon grandiflorus 10 parts, and raw Glycyrrhiza uralensis 10 parts.

[0007] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating lung cancer.

[0008] The present invention also provides a medicament for treating lung cancer, wherein the medicament comprises the above-mentioned traditional Chinese medicine composition.

[0009] Optionally, the dosage form of the drug includes decoction, capsule, tablet, granule, pill, powder, and oral liquid.

[0010] Optionally, the drug may also contain a pharmaceutically acceptable carrier or excipient.

[0011] Optionally, the excipients include excipient diluents, binders, disintegrants, lubricants, solubilizers, preservatives, flavoring agents, and coating materials.

[0012] The present invention also provides a method for preparing the above-mentioned drug. When the dosage form of the drug is a decoction, the preparation method includes the following steps: Crush the raw oyster and mix it with Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw Glycyrrhiza uralensis. Soak the mixture in water, decoct it twice, filter it, and combine the two filtrates to obtain the medicine.

[0013] Furthermore, the amount of water added is 8-10 times the total mass of the raw materials; the soaking time is 30-60 minutes; For the first decoction, bring to a boil over high heat, then simmer over low heat for 20-30 minutes. For the second decoction, add 6-8 times the amount of water to the dregs from the first decoction, bring to a boil over high heat, then simmer over low heat for 15-20 minutes.

[0014] Furthermore, when the dosage form of the drug is a capsule, the preparation method includes the following steps: The raw oyster is crushed and mixed with Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw Glycyrrhiza uralensis. After drying and pulverizing, a fine powder of medicinal materials is obtained. The fine powder of medicinal materials is mixed with excipients, made into granules, and loaded into capsules to obtain the drug.

[0015] Furthermore, the drying temperature is 60-80℃, and the drying is carried out until the moisture content is ≤8%; The powder is then passed through a 100-120 mesh sieve.

[0016] Optionally, the excipients include starch, lactose, micronized silica gel, and ethanol solution (adhesive), etc.

[0017] Furthermore, when the dosage form of the drug is a tablet, the preparation method includes the following steps: The raw oyster is crushed and mixed with Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw Glycyrrhiza uralensis. After drying and pulverizing, a fine powder of medicinal materials is obtained. The fine powder of medicinal materials is mixed with excipients and compressed into tablets to obtain the drug.

[0018] Furthermore, the drying temperature is 60-80℃, and the drying is carried out until the moisture content is ≤8%; The powder is then passed through a 100-mesh sieve.

[0019] Optionally, the excipients include starch (diluent), hydroxypropyl methylcellulose (adhesive), and magnesium stearate (lubricant).

[0020] The present invention discloses the following technical effects: Addressing the current challenges in lung cancer treatment and considering its pathogenesis, this invention provides a traditional Chinese medicine composition for treating lung cancer. This composition uses Bupleurum as the principal ingredient, with Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, and Actinidia chinensis root as assistant ingredients, and Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, raw oyster shell, stir-fried Perilla frutescens seed, and Platycodon grandiflorus as adjuvant ingredients, and raw Glycyrrhiza uralensis as the guiding ingredient. It combines multiple effects such as soothing the liver and regulating qi, clearing heat and resolving phlegm, softening and dispersing masses, tonifying qi and nourishing yin, cooling blood and stopping bleeding. It not only inhibits lung cancer tumor lesions but also focuses on regulating the patient's bodily functions, simultaneously supporting the body's resistance and eliminating pathogenic factors. This can effectively improve the clinical symptoms of lung cancer patients, enhance their quality of life, and prolong their survival. The composition of this invention uses natural Chinese medicinal materials, has a reasonable formula, is mild in nature, has no obvious toxic side effects, is well-tolerated by patients, and can be taken long-term. It can be prepared into various dosage forms such as decoctions, capsules, and tablets, making it convenient for different groups of people and applicable to a wide range of situations. It requires no complex equipment, is easy to operate, has low cost, is suitable for industrial production, and has good clinical application value.

[0021] The herbal composition of this invention can be used to prepare drugs for treating lung cancer, especially suitable for patients with intermediate and advanced lung cancer. It can be used alone or in combination with conventional clinical treatments such as radiotherapy, chemotherapy, and targeted therapy. When used in combination with radiotherapy and chemotherapy, this drug can effectively reduce the side effects of radiotherapy and chemotherapy, such as nausea, vomiting, fatigue, and bone marrow suppression, improve the patient's immunity, enhance the therapeutic effect of radiotherapy and chemotherapy, and improve the patient's quality of life. When used alone, it can inhibit the proliferation of lung cancer tumor cells, delay tumor progression, relieve clinical symptoms such as cough, wheezing, hemoptysis, and chest and rib pain, and prolong the patient's survival. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is the CT diagnostic report from Songyuan Jilin Oilfield Hospital before treatment of clinical case 1; Figure 2 This is the CT diagnostic report from the Cancer Hospital of the Chinese Academy of Medical Sciences before treatment of clinical case 1; Figure 3 This is the CT diagnostic report from Songyuan Jilin Oilfield Hospital after treatment of clinical case 1; Figure 4 This is the CT diagnostic report from Xuanwu Hospital of Capital Medical University before treatment of clinical case 2; Figure 5 The pathological results obtained by bronchoscopy at Xuanwu Hospital of Capital Medical University before the treatment of clinical case 2; Figure 6 This is the CT diagnostic report from Miyun District Hospital in Beijing after treatment of clinical case 2. Detailed Implementation

[0024] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0025] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0026] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0027] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0028] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0029] Unless otherwise specified, the experimental methods used in the following examples are conventional methods. Unless otherwise specified, the instruments and equipment used in the following examples are all conventional laboratory instruments and equipment; unless otherwise specified, the experimental materials used in the following examples were all purchased from conventional biochemical reagent stores.

[0030] The technical concept of this invention is as follows: Lung cancer falls under the categories of "lung accumulation" and "breath retention" in Traditional Chinese Medicine (TCM). Its pathogenesis is complex, often resulting from factors such as deficiency of vital energy (Qi), emotional imbalance, improper diet, and external pathogenic factors, leading to Qi stagnation, blood stasis, phlegm accumulation, and toxin accumulation, which over time form a mass. The core pathogenesis is a combination of deficiency and excess, specifically: deficiency of vital energy is the root cause, while Qi stagnation, phlegm accumulation, blood stasis, and toxin accumulation are the manifestations. These four factors intertwine and, over time, accumulate in the lungs to form a mass. Details are as follows: First, the deficiency of vital energy is the root cause of the disease: The onset of lung cancer is predicated on a deficiency of the body's vital energy, which allows pathogenic factors to take advantage of the weakness and accumulate over time, as discussed in numerous historical documents.

[0031] The Ling Shu (Spiritual Pivot) states in the chapter "Needling the Joints and True Evils": "When evil enters the body deeply, cold and heat fight each other, and it lingers for a long time and becomes internal... Evil qi resides in the middle and does not return, and it manifests as tendons and ducts... It congeals and becomes more and more serious every day, and it gathers together to form tumors." This clearly states that "the depletion of vital qi and the retention of evil qi" is the core premise for the formation of tumors, which is consistent with the pathogenesis of lung cancer, which is "deficiency of vital qi and invasion of evil qi".

[0032] The book "Essentials of Living Methods" states: "Strong people do not accumulate, but weak people do... Therefore, to treat accumulation, one should first nourish the body's vital energy, and the accumulation will naturally disappear." This directly clarifies that the deficiency of vital energy is the intrinsic root cause of accumulation syndromes (including lung accumulation), providing theoretical support for the "strengthening the body's vital energy and consolidating the foundation" treatment of lung cancer.

[0033] Secondly, qi stagnation is the beginning of phlegm and blood stasis: Emotional imbalance and qi stagnation are important contributing factors to the formation of pulmonary edema. When qi is not flowing smoothly, blood circulation is obstructed and body fluids stagnate, which in turn leads to the production of phlegm and blood stasis.

[0034] The earliest record of the disease name for lung accumulation is "Xi Ben" in the 56th chapter of the Classic of Difficult Issues. It says: "The accumulation in the lung is called Xi Ben. It is located under the right rib and is as large as a cup. The lung wants to return to the heart, but the heart refuses to accept it, so it accumulates and forms an accumulation." This indicates that the key pathogenesis of lung accumulation is the abnormal transmission of Qi and the accumulation in the lung.

[0035] The "Jisheng Fang" further explains: "When the qi of worry, joy, anger... is excessive, it will injure the five internal organs, go against the four seasons, and fail to be transmitted and controlled, thus accumulating and forming the five accumulations." It is clear that emotional injury leading to qi disorder is an important inducing factor for the occurrence of lung accumulation.

[0036] Thirdly, the mutual binding of phlegm and blood stasis forms the manifestation of accumulation: Phlegm and blood stasis combine and obstruct the lung meridians, which is the core pathological link in the formation of tangible tumors in lung cancer.

[0037] The Danxi Heart Method states: "If the lungs are distended and coughing occurs, or if one cannot sleep on the right side, this is because phlegm and blood stasis obstruct the flow of qi, causing illness." This directly relates to the pathogenesis of lung diseases and "phlegm and blood stasis intermingling," and is highly consistent with the clinical manifestations of lung cancer, such as cough, chest and rib pain, and tumor formation.

[0038] The Treatise on the Causes and Symptoms of Various Diseases states, “All phlegm is caused by the obstruction of blood vessels, causing water to accumulate and not dissipate, thus producing phlegm.” The Treatise on Blood Disorders adds, “When blood stasis persists for a long time, it can also transform into phlegm.” Together, they elucidate the pathological process in which phlegm and blood stasis are mutually causal, mutually generating and mutually transforming, and ultimately accumulate in the lungs to form an accumulation.

[0039] Fourth, toxin accumulation is a cause of disease progression: The lingering of pathogenic factors and the transformation of phlegm and blood stasis into toxins further deplete the body's vital energy and aggravate the accumulation of masses, which is an important mechanism for the protracted nature of lung cancer. Although there was no term "cancer toxin" in ancient times, the "Nan Jing" describes the condition of "Xi Ben" as "not healing for a long time, with chills and fever, shortness of breath and cough, and the development of lung abscess." The manifestations of "chills and fever, shortness of breath and cough, and not healing for a long time" are essentially pathological reactions of phlegm and blood stasis transforming into toxins and depleting the lung collaterals.

[0040] Based on the pathogenesis of lung cancer, this invention uses keywords such as "lung accumulation" and "breathing qi" from ancient texts to explore related syndromes and treatments for lung cancer. After compatibility verification, a traditional Chinese medicine composition for treating lung cancer was finally obtained. This composition targets the core pathogenesis of lung cancer patients, namely "phlegm and blood stasis, qi stagnation and yin deficiency, and deficiency of vital energy." It adopts the compatibility principles of soothing the liver and regulating qi, nourishing yin and resolving phlegm, softening and dispersing masses, tonifying qi and strengthening the body's resistance, and clearing heat and detoxifying. The formula is scientific and synergistic, which can effectively inhibit the growth of lung cancer tumors, alleviate clinical symptoms, and enhance the body's immunity.

[0041] This traditional Chinese medicine composition consists of the following raw medicinal materials: Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, raw oyster shell, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw licorice.

[0042] The efficacy and compatibility mechanisms of each raw medicinal material are as follows: Bupleurum: pungent, bitter, slightly cold, enters the liver and gallbladder meridians. Its functions are to soothe the liver and regulate qi, and harmonize the lesser yang. As the chief herb, it can relieve liver qi stagnation and break up qi stagnation, laying the foundation for subsequent phlegm-resolving, blood-cooling and hemostatic effects. It is effective for lung cancer patients with symptoms such as chest and rib pain and qi stagnation caused by qi stagnation.

[0043] Scutellaria barbata: bitter, cold, enters the lung, gallbladder, spleen, large intestine and small intestine meridians. Its functions are to clear heat and dry dampness, purge fire and detoxify. It is an assistant herb. When combined with Bupleurum chinense, it can enhance the effect of soothing the liver and clearing heat, clearing the internal heat, and targeting the toxic heat symptoms formed by qi stagnation and heat transformation and phlegm-heat accumulation in lung cancer patients. At the same time, it can restrain the drying properties of other warm herbs.

[0044] Trichosanthes kirilowii: sweet, slightly bitter, cold, enters the lung, stomach, and large intestine meridians, with the functions of clearing heat and resolving phlegm, relieving chest congestion and dissipating nodules, and moistening the intestines and promoting bowel movements; Fritillaria thunbergii: bitter, cold, enters the lung and heart meridians, with the functions of clearing heat and resolving phlegm, dissipating nodules and eliminating carbuncles. The two are used as assistant herbs, working together with Scutellaria barbata to clear heat and resolve phlegm, targeting the phlegm-heat stagnation syndrome in lung cancer patients. At the same time, Trichosanthes kirilowii relieves chest congestion and dissipates nodules, while Fritillaria thunbergii softens and dissipates nodules, which can directly act on the tumor lesions and relieve the symptoms of tumor compression.

[0045] The root of *Actinidia chinensis* is sour, astringent, and cool in nature. It enters the stomach and large intestine meridians. Its functions include clearing heat and detoxifying, dispelling wind and dampness, promoting blood circulation and reducing swelling. It is used as an assistant herb. Modern pharmacological studies have shown that it has certain anti-tumor activity, which can inhibit the proliferation of tumor cells, clear heat and toxins from the body, promote blood circulation and improve blood circulation around the tumor, and enhance the efficacy of other medicinal materials.

[0046] Scrophularia: sweet, bitter, salty, slightly cold, enters the lung, stomach, and kidney meridians. Its functions are to clear heat and cool blood, nourish yin and reduce fire, and detoxify and dissipate nodules. Astragalus: sweet, slightly warm, enters the spleen and lung meridians. Its functions are to replenish qi and raise yang, consolidate the exterior and stop sweating, and promote diuresis and reduce swelling. The two are used as adjuvant herbs. Scrophularia nourishes yin and cools blood, relieving the symptoms of yin deficiency and internal heat in lung cancer patients. Astragalus invigorates qi and strengthens the spleen, making up for the deficiency of the patient's vital energy, enhancing the body's immunity, and preventing the spread and metastasis of tumors. The two nourish and replenish, taking into account both supporting the body's resistance and eliminating pathogens.

[0047] Agrimony: bitter, astringent, neutral, enters the heart and liver meridians, with the functions of astringing and stopping bleeding, treating malaria, stopping dysentery, and detoxifying; Raw oyster: salty, slightly cold, enters the liver, gallbladder, and kidney meridians, with the functions of calming the mind, nourishing yin and yang, and softening and dispersing nodules. Together, they are adjuvant herbs. Agrimony is used to treat symptoms such as hemoptysis and blood in sputum that may occur in lung cancer patients, astringing and stopping bleeding without leaving blood stasis. Raw oyster softens and disperses nodules, enhancing the inhibitory effect on tumors, while calming the mind and relieving symptoms such as irritability and insomnia in patients.

[0048] Fried perilla seeds: pungent, warm, enters the lung and large intestine meridians, with the functions of lowering qi and resolving phlegm, relieving cough and asthma, and moistening the intestines and promoting bowel movement; Platycodon grandiflorus: bitter, pungent, neutral, enters the lung meridian, with the functions of clearing the lungs, benefiting the throat, resolving phlegm, and draining pus. The two are used as adjuvant drugs. Fried perilla seeds lower qi and resolve phlegm, which is effective for lung cancer patients with symptoms such as cough, asthma, and excessive phlegm. Platycodon grandiflorus clears the lungs and benefits the throat, carries the medicine upward, and guides the medicine directly to the lesion in the lung meridian, thereby enhancing the efficacy of the medicine.

[0049] Raw licorice: sweet, neutral, enters the heart, lung, spleen, and stomach meridians. Its functions include invigorating qi and tonifying the middle jiao, clearing heat and detoxifying, and harmonizing the effects of other herbs. As an adjuvant, it can moderate the properties of bitter and cold herbs in the formula to avoid damaging the spleen and stomach. At the same time, it harmonizes the compatibility between various herbs, so that all herbs can work together to enhance their effects and exert an overall therapeutic effect.

[0050] The traditional Chinese medicine composition of this invention features a rigorous formulation of principal, assistant, and adjuvant herbs, taking into account multiple effects such as soothing the liver and regulating qi, clearing heat and resolving phlegm, softening and dispersing masses, tonifying qi and nourishing yin, cooling blood and stopping bleeding. It not only inhibits lung cancer tumor lesions but also focuses on regulating the patient's bodily functions, simultaneously supporting the body's resistance and eliminating pathogenic factors. This approach can effectively improve the clinical symptoms of lung cancer patients, enhance their quality of life, and prolong their survival. The efficacy of the traditional Chinese medicine composition of this invention has been verified through the following examples: Example 1: Preparation and Application of Decoction Weigh out the raw medicinal materials: Bupleurum chinense 15g, Scutellaria barbata 15g, Trichosanthes kirilowii 20g, Fritillaria thunbergii 10g, Actinidia chinensis root 30g, Scrophularia ningpoensis 20g, Astragalus membranaceus 20g, Agrimonia pilosa 30g, raw oyster shell 30g, stir-fried Perilla frutescens seed 20g, Platycodon grandiflorus 10g, and raw Glycyrrhiza uralensis 10g.

[0051] Preparation method: Crush the raw oysters, pass them through a 24-mesh sieve, and put them into a decoction pot with the other medicinal materials. Add 8 times the amount of distilled water, soak for 40 minutes, bring to a boil over high heat, then simmer over low heat for 25 minutes. Filter and collect the first decoction. Add 6 times the amount of distilled water to the dregs, bring to a boil over high heat, then simmer over low heat for 20 minutes. Filter and collect the second decoction. Combine the two decoctions and divide them into two portions, each 200-300 mL.

[0052] Application method: This treatment is indicated for patients with mid-to-late stage lung adenocarcinoma. One dose is taken daily, divided into two warm administrations, for 30 consecutive days as one course of treatment. Clinical observations show that after taking this medication, patients experienced significant relief of cough and wheezing symptoms, disappearance of hemoptysis, improved physical condition, and control of tumor progression, with no significant side effects.

[0053] Example 2: Preparation and application of capsules Weigh out the following raw medicinal materials: Bupleurum chinense 150g, Scutellaria barbata 150g, Trichosanthes kirilowii 200g, Fritillaria thunbergii 100g, Actinidia chinensis root 300g, Scrophularia ningpoensis 200g, Astragalus membranaceus 200g, Agrimonia pilosa 300g, raw oyster shell 300g, stir-fried Perilla frutescens seed 200g, Platycodon grandiflorus 100g, and raw Glycyrrhiza uralensis 100g.

[0054] Preparation method: Crush raw oysters and dry them together with other medicinal materials at 70℃ until the moisture content is ≤8%. Grind them and pass them through a 120-mesh sieve to obtain fine powder of medicinal materials. Add 200g of starch and 10g of micronized silica gel to the fine powder, mix them evenly, use 75% ethanol solution as a binder, granulate, dry at 60℃, granulate, fill into empty capsules, make 1000 capsules, each with a content of 0.4g.

[0055] Application: This medication is used in combination with chemotherapy for patients with advanced squamous cell lung cancer. It is taken concurrently with chemotherapy, 5 tablets three times daily with warm water, for two consecutive chemotherapy cycles (21 days per cycle). Results showed that patients experienced significant reductions in gastrointestinal reactions such as nausea and vomiting, as well as bone marrow suppression symptoms, during chemotherapy. Immunity was improved, and the effective rate of chemotherapy was 15%-20% higher than that of the chemotherapy-only group.

[0056] Experimental Example 1 1. Case Source: A single-group retrospective medical record analysis was conducted, selecting 30 complete medical records from 2022 to 2025 of patients diagnosed with non-small cell lung cancer, diagnosed with Qi stagnation and phlegm accumulation, Qi deficiency, and toxic blood stasis according to Traditional Chinese Medicine (TCM) differentiation. These patients were divided into two categories based on whether they received Western medicine anti-tumor treatment: 1) Simple Chinese medicine group: 12 cases. Due to advanced age, multiple underlying diseases, and refusal of Western medicine anti-tumor treatments such as radiotherapy, chemotherapy / targeted therapy / immunotherapy, they only received symptomatic nutritional support + oral administration of the Chinese medicine composition decoction of this invention throughout the course of treatment (Example 1). 2) Chemotherapy combined with traditional Chinese medicine group: 18 cases, who received standard chemotherapy plus basic symptomatic treatment such as gastric protection, antiemetics, and white blood cell boosting (all from other hospitals, details unknown), and simultaneously took the decoction of the traditional Chinese medicine composition of this invention (Example 1).

[0057] All cases had a treatment duration of ≥90 days, with no cases of medication discontinuation or changes in the core treatment plan.

[0058] 2. Observation indicators: 1) Primary symptoms of lung cancer: cough with sputum, chest tightness and shortness of breath, blood in sputum, chest and rib pain, insomnia and irritability, fatigue and weakness; 2) Chemotherapy-specific toxic side effects (case records only for combined chemotherapy): nausea and vomiting, decreased appetite, and decreased white blood cell count; 3) Quality of life assessment: The total score of all symptoms is used as the quantitative standard for quality of life. The lower the score, the better the quality of life.

[0059] 3. Scoring and efficacy evaluation criteria: The following four-level scoring system is used: 0 points = no discomfort; 1 point = mild, does not affect daily life; 2 points = moderate, intermittently affects life; 3 points = severe, persistent discomfort; 4 points = very severe, unable to live a normal life.

[0060] 4. Evaluation of treatment efficacy for a single symptom: Clinically cured: score decreased by ≥90% from the initial diagnosis baseline; Significantly effective: 60% ≤ score decrease <90%; Effective: 30% ≤ score decrease <60%; Ineffective: score decrease <30% or symptoms worsened; Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases in this group × 100%.

[0061] 5. Observation time points: initial diagnosis baseline (0 days of medication), 30 days of continuous medication, and 90 days of continuous medication.

[0062] 6. Results The results are shown in Tables 1-3. To objectively evaluate the effects of the traditional Chinese medicine composition of this invention on improving clinical symptoms, reducing chemotherapy toxicity, and enhancing quality of life in patients with non-small cell lung cancer, a retrospective case analysis was conducted. A total of 30 patients diagnosed with non-small cell lung cancer were included and divided into two groups according to the clinical intervention plan: Group 1 consisted of 12 cases treated with traditional Chinese medicine alone. These patients, due to advanced age, multiple underlying chronic diseases, or subjective refusal of Western anti-tumor treatments such as surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy, received only basic nutrition and symptomatic support, and were given the traditional Chinese medicine decoction of this invention orally throughout the entire treatment (representative cases are shown in clinical cases 1 and 2); Group 2 consisted of 18 cases receiving combined traditional Chinese and Western medicine intervention. These patients received standard chemotherapy regimens, along with routine symptomatic treatments such as gastric protection, antiemetics, and white blood cell boosting, and continued oral administration of the traditional Chinese medicine composition of this invention. Symptom scores were recorded for all cases at baseline (day 0), day 30, and day 90. Self-comparison before and after treatment was used to evaluate the degree of symptom relief and changes in quality of life, and to observe the benefits of medication for the patients.

[0063] As shown in Table 1, for the group receiving only traditional Chinese medicine, the degree of clinical symptom relief in non-small cell lung cancer patients who did not receive Western anti-tumor treatment gradually improved with the duration of medication. At the initial diagnosis stage, multiple symptoms related to tumors, including cough, wheezing, chest pain, hemoptysis, insomnia, and fatigue, were present, with an overall total score of 17.97. After 30 days of continuous medication, the scores of all symptoms decreased significantly, with a more significant improvement in hemoptysis. By 90 days of medication, physical discomfort was further reduced, and most patients experienced a significant relief in their daily activities, resulting in a stable improvement in their quality of life.

[0064] As shown in Table 2, patients undergoing concurrent chemotherapy and traditional Chinese medicine treatment experienced both primary lung cancer symptoms and chemotherapy-induced gastrointestinal discomfort and bone marrow suppression at baseline, resulting in a higher overall symptom burden. After taking this traditional Chinese medicine combination for 30 days in addition to standard chemotherapy, both tumor-related symptoms and chemotherapy toxicities were simultaneously reduced. After 90 days of treatment, adverse reactions to chemotherapy such as nausea, vomiting, decreased appetite, and leukopenia were significantly controlled, while tumor-related symptoms such as cough, wheezing, and fatigue continued to improve. This effectively reduced the physical suffering caused by chemotherapy and improved patients' tolerance to chemotherapy.

[0065] As shown in Table 3, the efficacy statistics reveal a pattern in both groups where the longer the medication duration, the higher the symptom improvement rate. In the group treated with traditional Chinese medicine alone, the overall efficacy rate for all symptoms ranged from 68.33% to 83.33% after 30 days of treatment, increasing to 83.33% to 91.67% after 90 days, with the best improvement observed in hemoptysis. In the chemotherapy combined with traditional Chinese medicine group, in addition to the gradual relief of primary tumor symptoms, the overall efficacy rate for chemotherapy-related gastrointestinal and bone marrow suppression adverse reactions reached 83.33% to 88.89% after 90 days of treatment. Among all enrolled cases, only a few patients showed limited improvement, and no cases experienced a significant worsening of symptoms compared to baseline.

[0066] In summary, the herbal composition of this invention is suitable for different clinical intervention scenarios in non-small cell lung cancer: For patients who cannot tolerate or refuse Western anti-tumor treatment, long-term use alone can gradually alleviate tumor-related discomforts such as cough, chest tightness, hemoptysis, and fatigue, steadily improve daily quality of life, and stably delay lesion progression; For non-small cell lung cancer patients undergoing chemotherapy, the combination of this formula with standard chemotherapy can simultaneously alleviate primary tumor symptoms, reduce chemotherapy-induced nausea, vomiting, loss of appetite, and decreased white blood cell count, reduce physical suffering during chemotherapy, and ensure the smooth completion of the chemotherapy course. Whether used alone or in combination with chemotherapy, the symptom relief effect continues to improve with the extension of the medication period, and long-term follow-up of typical cases showed no symptom recurrence, demonstrating stable and reliable clinical application value.

[0067] Table 1. Average symptom scores of patients in the traditional Chinese medicine-only group (12 cases, without Western anti-tumor treatment) after different numbers of days of medication. Table 2. Average symptom scores of patients in the chemotherapy combined with traditional Chinese medicine group (18 cases, who received this formula in addition to chemotherapy) at different medication days. Table 3. Overall effective rate of symptom improvement in the two groups of cases after 30 days and 90 days of medication. Clinical Case 1 Ms. Yao, female, 74 years old. First visit on May 29, 2024. On April 17, 2024, the patient underwent a CT scan at Jilin Songyuan Oilfield Hospital due to "cough for more than a month without response to antibiotic treatment." The scan showed a 15×10mm nodule in the posterior segment of the right upper lobe, with irregular shape, spiculation, and lobulation, suggestive of malignancy (see...). Figure 1 On August 28, 2024, a CT scan at the Cancer Hospital of the Chinese Academy of Medical Sciences showed a 1.5×0.9×0.9cm nodule in the posterior segment of the right upper lobe. The nodule was irregular in shape with rough edges, and showed local adhesion and traction on the interlobar pleura, with slight pleural indentation in the affected area. Multiple enlarged lymph nodes were also observed in the mediastinum and hilum (see...). Figure 2 The patient was diagnosed with lung cancer by Western medicine and surgery, radiotherapy, and chemotherapy were recommended. Due to the patient's advanced age, the family preferred conservative treatment and consulted me.

[0068] Based on traditional Chinese medicine diagnosis, the patient currently presents with occasional cough, chest tightness, shortness of breath, irritability, difficulty falling asleep, and frequent awakenings. The tongue is dark red with a pale white coating and the pulse is slippery. This diagnosis matches the pattern described in this prescription, and the patient is given 168 doses of this decoction orally.

[0069] A follow-up CT scan conducted on February 13, 2025, at Jilin Songyuan Oilfield Hospital showed that the lung lesion and enlarged lymph nodes had disappeared. (See...) Figure 3 ).

[0070] Clinical Case 2 Mr. Liu, male, 71 years old. First visit on November 3, 2022. On September 7, 2022, the patient underwent a CT scan at Xuanwu Hospital of Capital Medical University due to "cough for one month," which showed: tracheal transection in the left upper lobe bronchus with surrounding obstructive changes (see...). Figure 4 On September 7, a bronchoscopy was performed and the pathology report showed squamous cell carcinoma (see...). Figure 5 Because the patient was elderly, the family wanted conservative treatment and consulted me.

[0071] Based on the TCM diagnosis, the patient's condition was found to be consistent with the pattern of this formula, and the patient was given this formula decoction for 4 months of treatment.

[0072] A follow-up CT scan at Miyun Hospital in Beijing in 2023 showed that the lungs were normal, with only a few nodules <5mm (see...). Figure 6 ).

[0073] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lung cancer, characterized in that, By weight, it includes the following raw materials: Bupleurum chinense 10-20 parts, Scutellaria barbata 10-20 parts, Trichosanthes kirilowii 10-30 parts, Fritillaria thunbergii 5-15 parts, Actinidia chinensis root 20-40 parts, Scrophularia ningpoensis 10-30 parts, Astragalus membranaceus 10-30 parts, Agrimonia pilosa 20-40 parts, raw oyster shell 20-40 parts, stir-fried Perilla frutescens seed 10-30 parts, Platycodon grandiflorus 5-15 parts, and raw Glycyrrhiza uralensis 5-15 parts.

2. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating lung cancer.

3. A drug for treating lung cancer, characterized in that, The drug comprises the traditional Chinese medicine composition according to claim 1.

4. The drug according to claim 3, characterized in that, The dosage forms of the drug include decoctions, capsules, tablets, granules, pills, powders, and oral liquids.

5. The method for preparing the drug according to claim 3 or 4, characterized in that, When the dosage form of the drug is a decoction, the preparation method includes the following steps: Crush the raw oyster and mix it with Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw Glycyrrhiza uralensis. Soak the mixture in water, decoct it twice, filter it, and combine the two filtrates to obtain the medicine.

6. The preparation method according to claim 5, characterized in that, The amount of water added is 8-10 times the total mass of the raw materials; the soaking time is 30-60 minutes; For the first decoction, bring to a boil over high heat, then simmer over low heat for 20-30 minutes. For the second decoction, add 6-8 times the amount of water to the dregs from the first decoction, bring to a boil over high heat, then simmer over low heat for 15-20 minutes.

7. The preparation method according to claim 5, characterized in that, When the dosage form of the drug is a capsule, the preparation method includes the following steps: The raw oyster is crushed and mixed with Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw Glycyrrhiza uralensis. After drying and pulverizing, a fine powder of medicinal materials is obtained. The fine powder of medicinal materials is mixed with excipients, made into granules, and loaded into capsules to obtain the drug.

8. The preparation method according to claim 7, characterized in that, The drying temperature is 60-80℃, and the drying is carried out until the moisture content is ≤8%. The powder is then passed through a 100-120 mesh sieve.

9. The preparation method according to claim 5, characterized in that, When the dosage form of the drug is a tablet, the preparation method includes the following steps: The raw oyster is crushed and mixed with Bupleurum, Scutellaria barbata, Trichosanthes kirilowii, Fritillaria thunbergii, Actinidia chinensis root, Scrophularia ningpoensis, Astragalus membranaceus, Agrimonia pilosa, stir-fried Perilla frutescens seed, Platycodon grandiflorus, and raw Glycyrrhiza uralensis. After drying and pulverizing, a fine powder of medicinal materials is obtained. The fine powder of medicinal materials is mixed with excipients and compressed into tablets to obtain the drug.

10. The preparation method according to claim 9, characterized in that, The drying temperature is 60-80℃, and the drying is carried out until the moisture content is ≤8%. The powder is then passed through a 100-mesh sieve.

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