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

Abstract

This invention provides a traditional Chinese medicine composition for treating squamous cell carcinoma of the lung, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition for treating squamous cell carcinoma of the lung provided by this invention comprises the following raw materials in parts by weight: 20-30 parts of Ziziphus jujuba seed, 15-20 parts of ginseng, 10-15 parts of dried ginger, 15-30 parts of stir-fried Atractylodes macrocephala, 40-50 parts of Paeonia lactiflora, 20-30 parts of Rehmannia glutinosa, 15-20 parts of Trichosanthes kirilowii root, 40-50 parts of stir-fried Coix lacryma-jobi, 5-7 parts of honey-processed Ephedra sinica, 20-30 parts of Poria cocos, 5-10 parts of frankincense, 5-10 parts of myrrh, 10-20 parts of Alpinia oxyphylla, 20-30 parts of vinegar-processed tortoise shell, 20-30 parts of vinegar-processed turtle shell, 10-20 parts of Albizia julibrissin bark, and 9-12 parts of prepared licorice root. The aforementioned traditional Chinese medicine composition can effectively improve various clinical symptoms caused by squamous cell carcinoma of the lung, while inhibiting the growth and metastasis of the cancer cells, with significant effects and no side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating squamous cell carcinoma of the lung, its preparation method, and its application. Background Technology

[0002] Lung cancer is a malignant tumor with relatively high incidence and mortality rates worldwide. Histologically, lung cancer is divided into two main categories: non-small cell lung cancer (NSCLC) and small cell lung cancer, with NSCLC accounting for 85% of all lung cancer cases. Early-stage lung cancer often presents with no obvious symptoms, and most patients are diagnosed at an advanced stage, with an overall 5-year survival rate of only 15%. Traditional platinum-based doublet chemotherapy has low efficacy, short remission time, and limited survival benefits. Squamous cell carcinoma of the lung is one of the most common histological subtypes of lung cancer, accounting for approximately 30% of NSCLC patients. Early-stage squamous cell carcinoma of the lung lacks obvious symptoms, and most patients are diagnosed at an advanced stage, losing the opportunity for surgical treatment. Unlike lung adenocarcinoma, only a very small number of patients with squamous cell carcinoma of the lung have driver genes such as epidermal growth factor receptor mutations or anaplastic lymphoma kinase gene rearrangements, thus lacking opportunities for targeted drug therapy.

[0003] In recent years, numerous clinical studies have demonstrated that, compared to traditional chemotherapy, ICIs (intracellular immunotherapy) monotherapy or combination chemotherapy regimens can significantly improve the treatment response rate and survival time of patients with advanced squamous cell lung cancer, even leading to a change in the treatment paradigm for squamous cell lung cancer. However, clinically, only 15%–30% of patients with advanced NSCLC can achieve sustained remission and long-term survival through immunotherapy. Squamous cell lung cancer is more common in elderly male smokers, with 40% of patients diagnosed at the age of over 70. Elderly patients often have chronic comorbidities, decreased organ reserve function, and poor tolerance to chemotherapy drugs, exhibiting unique pharmacokinetic and clinical biological characteristics. Significant progress has been made in the application of traditional Chinese medicine (TCM) in cancer treatment in recent years. Therefore, the intervention of TCM is expected to improve patients' quality of life and prolong their survival to some extent, and can also be combined with targeted therapies to reduce toxicity and enhance efficacy. Currently, there are reports on various Chinese herbal medicines used for cancer treatment; however, there are no reports on TCM formulas specifically for the treatment of squamous cell lung cancer. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating squamous cell carcinoma of the lung. Based on many years of clinical treatment experience, this traditional Chinese medicine composition can effectively improve a variety of clinical symptoms caused by squamous cell carcinoma of the lung, with significant effects and no side effects.

[0005] This invention provides a traditional Chinese medicine composition for treating squamous cell carcinoma of the lung, comprising the following raw materials in parts by weight:

[0006] The ingredients are: 20-30 parts of jujube seed, 15-20 parts of ginseng, 10-15 parts of dried ginger, 15-30 parts of stir-fried atractylodes macrocephala, 40-50 parts of white peony root, 20-30 parts of prepared rehmannia root, 15-20 parts of trichosanthes root, 40-50 parts of stir-fried coix seed, 5-7 parts of honey-processed ephedra, 20-30 parts of poria cocos, 5-10 parts of frankincense, 5-10 parts of myrrh, 10-20 parts of alpinia oxyphylla, 20-30 parts of vinegar-processed tortoise shell, 20-30 parts of vinegar-processed turtle shell, 10-20 parts of albizia bark, and 9-12 parts of prepared licorice root.

[0007] Preferably, the raw materials include the following parts by weight:

[0008] 30 parts of jujube seed, 20 parts of ginseng, 15 parts of dried ginger, 20 parts of stir-fried atractylodes macrocephala, 50 parts of white peony root, 30 parts of prepared rehmannia root, 20 parts of trichosanthes root, 50 parts of stir-fried coix seed, 7 parts of honey-processed ephedra, 30 parts of poria cocos, 7 parts of frankincense, 7 parts of myrrh, 15 parts of alpinia oxyphylla, 20 parts of vinegar-processed tortoise shell, 20 parts of vinegar-processed turtle shell, 15 parts of albizia bark, and 10 parts of prepared licorice root.

[0009] This invention provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0010] The following herbs were decocted: jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root. The decoction was then separated to obtain a traditional Chinese medicine composition.

[0011] Preferably, the decoction method involves bringing the medicinal liquid to a boil over high heat, then simmering it over low heat.

[0012] Preferably, the decocting is performed 2 to 3 times.

[0013] Preferably, the first or second simmering time is 20 to 40 minutes each;

[0014] The third simmering time is 15-25 minutes.

[0015] Preferably, the amount of water used in each decoction is 2-3 cm above the level of the raw materials or the level of the dregs.

[0016] Preferably, before decocting, the following ingredients are soaked in water: jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root; the soaking time is 15-25 minutes.

[0017] This invention provides the use of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the preparation method in the preparation of drugs for the prevention and / or treatment of squamous cell carcinoma of the lung.

[0018] This invention provides a traditional Chinese medicine honey pill for treating squamous cell carcinoma of the lung, comprising honey and the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition obtained by the preparation method described above;

[0019] The mass ratio of the raw materials in the honey and the traditional Chinese medicine composition is (1.2-1.5):1.

[0020] The traditional Chinese medicine composition for treating squamous cell carcinoma of the lung provided by this invention comprises the following raw materials in parts by weight: 20-30 parts of jujube seed, 15-20 parts of ginseng, 10-15 parts of dried ginger, 15-30 parts of stir-fried atractylodes macrocephala, 40-50 parts of white peony root, 20-30 parts of prepared rehmannia root, 15-20 parts of trichosanthes root, 40-50 parts of stir-fried coix seed, 5-7 parts of honey-processed ephedra, 20-30 parts of poria cocos, 5-10 parts of frankincense, 5-10 parts of myrrh, 10-20 parts of alpinia oxyphylla, 20-30 parts of vinegar-processed tortoise shell, 20-30 parts of vinegar-processed turtle shell, 10-20 parts of albizia bark, and 9-12 parts of prepared licorice root. In the aforementioned herbal composition, jujube seed nourishes the heart and calms the mind, restoring the heart's function of governing the mind; ginseng greatly replenishes vital energy, invigorates qi and generates fluids, and, combined with jujube seed, enhances its ability to nourish the heart and calm the mind, assisting the heart and spirit; the spleen and stomach are the foundation of acquired constitution, dried ginger warms the middle jiao (spleen and stomach), stir-fried atractylodes macrocephala invigorates the middle jiao, replenishes qi, dries the spleen and removes dampness, and, together with ginseng and licorice, achieves the effect of regulating the middle jiao, warming and tonifying the middle jiao, nourishing the earth to generate metal, restoring the function of qi transformation and opening and closing of the pores, so that lung qi can be restored, the heart can be nourished, and the spirit can be relied upon; prepared rehmannia root nourishes yin, replenishes blood and benefits essence, and white... Peony root softens the liver and nourishes yin, suppressing excessive liver yang through nourishment instead of purging; Trichosanthes root generates fluids, nourishes the heart, and eliminates carbuncles and pus; Poria calms the mind and soothes the nerves, tonifying the heart and spleen; Albizia bark calms the nerves and relieves depression, assisting the heart and spirit, and aiding Ziziphus jujuba seed in regulating the heart and spirit; stir-fried Coix seed and Alpinia oxyphylla strengthen the spleen and promote diuresis; Frankincense and Myrrh invigorate blood and remove blood stasis; Vinegar-processed Tortoise Shell and Vinegar-processed Turtle Shell break up accumulations and eliminate masses; Honey-processed Ephedra promotes lung function, strengthens the exterior, and regulates qi; Prepared Licorice harmonizes all the herbs. The combined effects of these herbs promote spleen and stomach function, clear the mind, and restore the spirit's control, thus altering the metabolic environment. Applying the traditional Chinese medicine composition described in this invention to patients diagnosed with squamous cell carcinoma of the lung by Western medicine significantly alleviates the clinical symptoms of squamous cell carcinoma and significantly inhibits tumor growth and metastasis. The overall effective rate based on TCM symptom scores reached 76.5%, and the disease remission rate based on imaging results was over 64.7%. It is evident that the traditional Chinese medicine composition provided by this invention offers a new approach for the treatment or adjuvant treatment of squamous cell carcinoma of the lung, greatly alleviating patient suffering. Moreover, the raw materials are all plant-derived components, possessing drug safety, and can be promoted and applied clinically. Attached Figure Description

[0021] Figure 1The efficacy verification results of the traditional Chinese medicine composition provided by the present invention are as follows: A is the result of CCK-8 assay on the survival rate of human lung epithelial cells BEAS-2B after serum treatment containing XJSJF (5%, 10%, and 20%); B is the result of CCK-8 assay on the survival rate of SK-MES-1 cells after serum treatment containing XJSJF (5%, 10%, and 20%), **P < 0.01 vs. normal serum group; untreated cells served as the control group; C is the mRNA expression of CCL2, IL1B, IL6, STAT3, and PTGS2 in SK-MES-1 cells after treatment with serum containing 20% ​​XJSJF, **P < 0.01 vs. control group;

[0022] Figure 2 Volcano plot (left) and heatmap (right) of differentially expressed genes in GSE3268;

[0023] Figure 3 A Venn diagram showing the target genes of drugs acting on squamous cell carcinoma of the lung;

[0024] Figure 4 This is a network diagram of drugs, target genes, and active ingredients, where blue represents active ingredients, green represents drugs, and brown represents genes.

[0025] Figure 5 This is a PPI network diagram. Note: the darker the color, the greater the degree of intensity.

[0026] Figure 6 Results of PPI network core gene calculations using various algorithms;

[0027] Figure 7 This is a graph showing the intersection of core genes in the PPI network.

[0028] Figure 8 GO enrichment bar chart for the top 10;

[0029] Figure 9 A bar chart showing the top 10 KEGG enrichment values;

[0030] Figure 10 Survival KM curves for CCL2, IL1B, and IL6;

[0031] Figure 11 The main signaling pathways involved by CCL2, IL1B, and IL6;

[0032] Figure 12 The results show the docking of CCL2 and CID_445154 molecules;

[0033] Figure 13 The results show the docking of CCL2 and CID_5280343 molecules;

[0034] Figure 14 Results of IL1B docking with CID_445154 molecules;

[0035] Figure 15 Results of IL1B docking with CID_5280343 molecules;

[0036] Figure 16 The results show the docking of IL6 with CID_445154 molecules;

[0037] Figure 17 The results show the molecular docking of IL6 and CID_5280343. Detailed Implementation

[0038] This invention provides a traditional Chinese medicine composition for treating squamous cell carcinoma of the lung, comprising the following raw materials in parts by weight:

[0039] The ingredients are: 20-30 parts of jujube seed, 15-20 parts of ginseng, 10-15 parts of dried ginger, 15-30 parts of stir-fried atractylodes macrocephala, 40-50 parts of white peony root, 20-30 parts of prepared rehmannia root, 15-20 parts of trichosanthes root, 40-50 parts of stir-fried coix seed, 5-7 parts of honey-processed ephedra, 20-30 parts of poria cocos, 5-10 parts of frankincense, 5-10 parts of myrrh, 10-20 parts of alpinia oxyphylla, 20-30 parts of vinegar-processed tortoise shell, 20-30 parts of vinegar-processed turtle shell, 10-20 parts of albizia bark, and 9-12 parts of prepared licorice root.

[0040] In this invention, the raw material of the traditional Chinese medicine composition includes jujube seed. The jujube seed is preferably 25-30 parts by weight, and most preferably 30 parts. This invention does not specifically limit the source of the jujube seed; it can be prepared using conventional processing methods or be a commercially available product. The jujube seed has the effect of nourishing the heart and calming the mind.

[0041] In this invention, the raw material of the traditional Chinese medicine composition includes ginseng. The ginseng is preferably 18-20 parts by weight, and most preferably 20 parts. This invention does not have a special limitation on the source of the ginseng; conventional commercially available products are acceptable. The ginseng has the effect of greatly replenishing vital energy.

[0042] In this invention, the raw material of the traditional Chinese medicine composition includes dried ginger. The dried ginger is preferably 12-15 parts by weight, and most preferably 15 parts. This invention does not have a special limitation on the source of the dried ginger; conventional commercially available products are acceptable. The dried ginger has the effect of warming and tonifying the middle jiao (middle burner).

[0043] In this invention, the raw material of the traditional Chinese medicine composition includes stir-fried Atractylodes macrocephala. The stir-fried Atractylodes macrocephala is preferably 20-30 parts by weight, and most preferably 20 parts. This invention does not specifically limit the source of the stir-fried Atractylodes macrocephala; it can be prepared using conventional processing methods or be a commercially available product. The stir-fried Atractylodes macrocephala has the functions of tonifying the middle energizer and replenishing qi, drying the spleen and removing dampness.

[0044] In this invention, the raw material of the traditional Chinese medicine composition includes white peony root. The white peony root is preferably 42-50 parts by weight, and most preferably 50 parts. This invention does not have a special limitation on the source of the white peony root; conventional commercially available products are acceptable. The white peony root has the effect of soothing the liver and astringing yin.

[0045] In this invention, the raw material of the traditional Chinese medicine composition includes Rehmannia glutinosa (processed). The Rehmannia glutinosa is preferably 23-30 parts by weight, and most preferably 30 parts. This invention does not have a special limitation on the source of the Rehmannia glutinosa; conventional commercially available products are acceptable. The Rehmannia glutinosa has the effects of nourishing yin, replenishing blood, and benefiting essence.

[0046] In this invention, the raw material of the traditional Chinese medicine composition includes Trichosanthes kirilowii root. The Trichosanthes kirilowii root is preferably 18-20 parts by weight, and most preferably 20 parts. This invention does not have a special limitation on the source of the Trichosanthes kirilowii root; conventional commercially available products are acceptable. The Trichosanthes kirilowii root has the effects of promoting body fluid production, nourishing the heart, and relieving carbuncles and draining pus.

[0047] In this invention, the raw material of the traditional Chinese medicine composition includes stir-fried coix seed. The stir-fried coix seed is preferably 43-50 parts by weight, and most preferably 50 parts. This invention does not specifically limit the source of the stir-fried coix seed; it can be prepared using conventional processing methods or be a commercially available product. The stir-fried coix seed has the effect of strengthening the spleen and promoting diuresis.

[0048] In this invention, the raw material of the traditional Chinese medicine composition includes honey-processed ephedra. Preferably, the honey-processed ephedra comprises 6-7 parts by weight, and most preferably 7 parts. This invention does not specifically limit the source of the honey-processed ephedra; conventional commercially available products are acceptable. The honey-processed ephedra has the effects of clearing the lungs, consolidating the exterior, and promoting the smooth flow of Qi.

[0049] In this invention, the raw material of the traditional Chinese medicine composition includes Poria cocos. The preferred amount of Poria cocos by weight is 23-30 parts, and most preferably 30 parts. This invention does not have a special limitation on the source of the Poria cocos; conventional commercially available products are acceptable. The Poria cocos has the effect of calming the mind and soothing the nerves.

[0050] In this invention, the raw material of the traditional Chinese medicine composition includes frankincense. Preferably, the frankincense comprises 6-8 parts by weight, and most preferably 7 parts. This invention does not have a specific limitation on the source of the frankincense; conventional commercially available products are acceptable. The frankincense has the effect of promoting blood circulation and removing blood stasis.

[0051] In this invention, the raw material of the traditional Chinese medicine composition includes myrrh. The myrrh is preferably 6-8 parts by weight, and most preferably 7 parts. This invention does not have a special limitation on the source of the myrrh; conventional commercially available products are sufficient. The myrrh has the effect of promoting blood circulation and removing blood stasis.

[0052] In this invention, the raw material of the traditional Chinese medicine composition includes Alpinia oxyphylla. The Alpinia oxyphylla is preferably 13-17 parts by weight, and most preferably 15 parts. This invention does not have a special limitation on the source of the Alpinia oxyphylla; conventional commercially available products are acceptable. The Alpinia oxyphylla has the effect of strengthening the spleen and promoting diuresis.

[0053] In this invention, the raw material of the traditional Chinese medicine composition includes vinegar-processed tortoise shell. The vinegar-processed tortoise shell is preferably 20-27 parts by weight, and most preferably 20 parts. This invention does not specifically limit the source of the vinegar-processed tortoise shell; it can be prepared using conventional processing methods or be a commercially available product. The vinegar-processed tortoise shell has the effect of breaking up accumulations and eliminating masses.

[0054] In this invention, the raw material of the traditional Chinese medicine composition includes vinegar-processed turtle shell. The vinegar-processed turtle shell is preferably 20-27 parts by weight, and most preferably 20 parts. This invention does not specifically limit the source of the vinegar-processed turtle shell; it can be prepared using conventional processing methods or be a commercially available product. In this invention, the vinegar-processed turtle shell has the effect of breaking up accumulations and eliminating masses.

[0055] In this invention, the raw material of the traditional Chinese medicine composition includes Albizia bark. Preferred amounts of Albizia bark are 13-17 parts by weight, and most preferably 15 parts. This invention does not have a specific limitation on the source of the Albizia bark; conventional commercially available products are acceptable. In this invention, the Albizia bark has a calming and mood-lifting effect.

[0056] In this invention, the raw material of the traditional Chinese medicine composition includes prepared licorice root. The prepared licorice root is preferably 10-11 parts by weight, and most preferably 10 parts. This invention does not have a special limitation on the source of the prepared licorice root; conventional commercially available products are sufficient. In this invention, the prepared licorice root has the function of harmonizing the various medicinal ingredients.

[0057] The traditional Chinese medicine composition provided by this invention has been obtained through years of clinical verification and continuous optimization. The specific optimization process is as follows: (I) Tracing the origin and understanding lung cancer.

[0058] Regarding the understanding of tumor pathogenesis, the *Huangdi Neijing* (Yellow Emperor's Inner Classic) states, "When pathogenic factors invade the body... they linger in the vessels, persisting and not being expelled, eventually forming accumulations." The *Lingshu* (Spiritual Pivot) states, "When Qi rises in reverse, the six channels become obstructed, warm Qi cannot circulate, blood congeals and accumulates internally without dispersing, and body fluids become stagnant and seep, lingering and not being expelled, thus accumulations form." It is evident that tumor pathogenesis is characterized by deficiency in the root and excess in the branch. Deficiency in the root can be differentiated into Qi, blood, Yin, and Yang deficiency, while excess in the branch refers to pulmonary lesions formed by pathological products such as Qi stagnation, blood stasis, and phlegm accumulation. Conversely, already formed pulmonary lesions obstruct the flow of Qi, further aggravating Qi stagnation, blood stasis, and phlegm accumulation, causing the pulmonary lesions to continuously accumulate and grow. The inventor, in clinical practice treating patients with squamous cell carcinoma of the lung, observed clinical manifestations beyond visible pulmonary lesions on imaging, including cough, absence of sputum or white sticky sputum, abdominal distension and loose stools, dry mouth and shortness of breath, sallow complexion, fatigue, aversion to cold and cold limbs, abnormal sweating, mood or sleep disturbances, pale and swollen tongue with a white coating, and a deep and thready pulse. Based on the Eight Principles of Differentiation, this was analyzed as a case of Yang deficiency and cold excess. Combining this with the Zang-Fu differentiation method, the disease location was considered to be in the lungs, related to the spleen and liver. Lung disease accumulation affects the functions of governing Qi, respiration, and the circulation of Qi throughout the body, resulting in symptoms such as cough, sputum production, and shortness of breath. Insufficient respiration leads to deficiency of Zong Qi (ancestral Qi), insufficient Yang Qi, and internal excess of Yin cold, hence the sallow complexion, fatigue, aversion to cold, and cold limbs. The lungs and spleen have a mother-child relationship, physiologically related and pathologically interrelated. Lung disease accumulation inevitably leads to spleen yang deficiency, resulting in obstruction by cold and dampness, and the internal generation of phlegm and fluid retention. This manifests as abdominal distension, loose stools, dry mouth, pale and swollen tongue with a white coating, and a deep and thready pulse. In summary, lung squamous cell carcinoma patients are fundamentally suffering from lung and spleen yang deficiency. The prescription utilizes modifications of classic formulas such as Lizhong Decoction (dried ginger, stir-fried Atractylodes macrocephala, ginseng), Ma Huang Decoction (prepared ephedra, prepared licorice root), and Linggui Zhugan Decoction (Poria cocos, stir-fried Atractylodes macrocephala, prepared licorice root), with a small amount of white mustard seed added to warm the lungs, dispel cold, unblock the channels, and eliminate phlegm; and Alpinia oxyphylla to warm the kidneys and spleen, strengthen the body's foundation, and replenish deficiencies while simultaneously interrupting the production of pathological products.

[0059] On the other hand, regarding the understanding of tumor lesions, the *Zhongzang Jing* states: "The formation of carbuncles, boils, and sores is all due to the accumulation of toxins in the five viscera and six bowels, which, if not released, will lead to their development. It is not solely due to the obstruction of the *ying* and *wei*." It considers tumors to arise from the "accumulation of toxins" in the viscera. The *Weiji Baoshu* lists "cancer" as one of the "five types" of carbuncles. The *Ren Zhai Zhizhi Fu Yi Fang Lun* proposes that cancer is caused by "deeply hidden toxins," and initiated the exploration of bitter-cold detoxification methods for treating cancer. The inventor believed that the retention of lesions in the lungs affects the ascending and descending of *qi*, impairs the liver's function of dispersing and regulating, and simultaneously disrupts the lung's flow, leading to qi stagnation, blood stasis, phlegm accumulation, and the transformation of *qi* into fire. The local fire within the tumor lesion is the root cause of its continuous accumulation and growth. Therefore, clearing heat, detoxifying, nourishing yin, and reducing fire are methods for treating the superficial symptoms (lesions). The formula incorporates classic carbuncle and boil prescriptions such as Xianfang Huoming Yin (Trichosanthes kirilowii, frankincense, and myrrh), Yiyifuzi Baijiang San (stir-fried coix seed and Patrinia scabiosaefolia), and Sanjia Fupai Tang (white peony root, vinegar-processed tortoise shell, and vinegar-processed turtle shell), with modifications, to achieve the purpose of detoxifying and draining pus from the lesion, calming the liver and reducing fire. In addition, the inventors found that lung cancer patients all had varying degrees of emotional or sleep abnormalities, which they considered to be indirectly caused by dysfunction of the internal organs leading to mental and emotional disturbances and insufficient heart fluids. Therefore, the formula was supplemented with Albizia julibrissin bark to calm the mind, relieve depression, and soothe the nerves. In summary, the ingredients for the formula for treating squamous cell carcinoma of the lung are as follows: 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 10 parts ginseng, 10 parts prepared licorice root, 20 parts Trichosanthes kirilowii root, 20 parts white peony root, 30 parts stir-fried coix seed, 7 parts prepared ephedra, 30 parts Poria cocos, 7 parts frankincense, 7 parts myrrh, 15 parts Alpinia oxyphylla, 15 parts vinegar-processed tortoise shell, 15 parts vinegar-processed turtle shell, 15 parts Albizia julibrissin bark, 10 parts white mustard seed, and 20 parts Patrinia scabiosaefolia (Prescription 1).

[0060] (ii) Exploring the crux of the problem, losing mental control.

[0061] Prescription 1, after clinical verification, was found to be ineffective in improving abnormal sweating, mood disorders, or sleep disturbances. It was gradually recognized that the uncontrolled, uncontrolled growth of pulmonary lesions is a key factor distinguishing lung cancer from other diseases. The *Suwen* (Plain Questions) states, "The heart is the sovereign organ, from which the spirit emerges." This indicates that the heart is the commander of the spirit. The *Lingshu* (Spiritual Pivot) states, "The heart is the great master of the five viscera and six bowels, the abode of the spirit." The *Lingshu* also states, "That which governs things is called the heart," meaning the heart has the ability to manage and process things. When the sovereign is wise, the subordinates are at peace; when the sovereign is unwise, the twelve organs are in danger, and the functions of all the organs lose coordination. At this point, Professor Wang Tan proposed that the key to treating lung cancer lies in calming the mind and spirit. Qi and blood are the substance, and spirit is the function. Sufficient qi and blood result in abundant spirit and coordinated organ functions. Therefore, based on the previous prescription, ginseng is used in greater quantities, and jujube seed is added, with these as the principal herbs. Ginseng belongs to the heart, lung, and spleen meridians, and can preserve qi and spirit, nourish the heart and lungs, playing an important role in restoring the heart's function of governing the mind and replenishing lung qi. Sour jujube seed, together with licorice and poria, forms Sour Jujube Seed Decoction, which nourishes heart blood and liver blood, strengthens the heart's function of governing the mind, and inhibits tumor growth. Therefore, prescription 2 was optimized: the dosage of ginseng in prescription 1 was increased to 20 parts, and 20 parts of sour jujube seed were added.

[0062] (III) Focus on the long term, reduce losses and increase efficiency.

[0063] Prescription 2 contains white mustard seed, which is pungent and warm in nature, clearing phlegm, promoting qi circulation, dispersing nodules, and unblocking the meridians. It is mainly for those with excessive cold phlegm and obstruction of the meridians. Long-term use can easily lead to lung deficiency and loss of moisture, so it is contraindicated for those with lung deficiency cough or yin deficiency with fire excess. Patrinia scabiosifolia, on the other hand, is pungent, bitter, and cold in nature, and has strong effects of clearing heat and detoxifying, promoting blood circulation and draining pus. The "Compendium of Materia Medica" points out that Patrinia scabiosifolia is contraindicated for "prolonged illness with weak stomach and spleen, diarrhea and loss of appetite, and all diseases of deficiency and cold with prolapse." Lung cancer patients are based on deficiency, so prescription 2 is not suitable for long-term use. In addition, one of the two herbs is cold and the other is hot, mainly for expectorants for patients with excessive phlegm. Clinically, one should be selected as an addition or subtraction drug according to the presence or absence of symptoms and the severity of cold and heat. Therefore, the two herbs are deleted from the basic prescription. Prescription 3 is obtained by removing white mustard seed and Patrinia scabiosifolia from prescription 2.

[0064] (iv) Exquisite craftsmanship, balancing yin and yang.

[0065] Squamous cell carcinoma of the lung will exploit the body's essential nutrients for its own use, eventually leading to a deficiency of both Yin and Yang. Lung stagnation obstructs the flow of Yang Qi, hindering the upward movement of Shao Yang Qi. Stagnant heat consumes body fluids, depleting the essence of the lower abdomen, and ultimately damaging Yin as well. Insufficient kidney essence nourishes the liver, and insufficient liver blood prevents Yang Qi from reaching its proper place. Furthermore, since the stomach is the gateway to the kidneys, those with weak spleen and stomach often exhibit insufficient kidney essence. Rehmannia glutinosa (Shu Di Huang) is a key herb for nourishing Yin and replenishing essence, providing nourishment without being cloying. Therefore, adding Rehmannia glutinosa to strengthen the innate constitution and nourish the acquired constitution achieves the therapeutic goal of Yin-Yang balance and overall well-being. Prescription 4: Based on prescription 3, add 30 parts of Rehmannia glutinosa.

[0066] The final composition of the traditional Chinese medicine compound is as follows: 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 20 parts ginseng, 10 parts prepared licorice root, 20 parts Trichosanthes kirilowii root, 20 parts white peony root, 30 parts stir-fried coix seed, 7 parts prepared ephedra, 30 parts Poria cocos, 7 parts frankincense, 7 parts myrrh, 15 parts Alpinia oxyphylla, 15 parts vinegar-processed tortoise shell, 15 parts vinegar-processed turtle shell, 15 parts Albizia julibrissin bark, and 30 parts prepared Rehmannia glutinosa.

[0067] This invention provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0068] The following herbs were decocted: jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root. The decoction was then separated to obtain a traditional Chinese medicine composition.

[0069] In this invention, before decoction, it is preferable to soak the following ingredients in water: jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root; the soaking time is preferably 15-25 minutes, more preferably 20 minutes. Soaking helps to improve the dissolution of active ingredients in the water during subsequent decoction, thereby enhancing the efficacy.

[0070] In this invention, the preferred method of decoction is to bring the medicinal liquid to a boil over high heat, then simmer over low heat. The decoction is preferably performed three times. The first or second simmering time is preferably 20-40 minutes, more preferably 30 minutes. When decocted three times, the third simmering time is preferably 15-25 minutes, more preferably 20 minutes. Each time, the water level is preferably 2-3 cm above the level of the raw materials or the dregs. The three decoctions are combined to obtain the traditional Chinese medicine composition. Multiple decoctions facilitate the full extraction of active ingredients from the raw materials, improving efficacy.

[0071] This invention provides the use of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the preparation method in the preparation of drugs for the prevention and / or treatment of squamous cell carcinoma of the lung.

[0072] In this invention, the dosage form of the drug preferably includes at least one of the following: tablets, granules, capsules, and oral liquid preparations. This invention does not impose any particular limitation on the preparation method of the drug; any preparation method for a drug dosage form well known in the art can be used.

[0073] This invention provides a traditional Chinese medicine honey pill for treating squamous cell carcinoma of the lung, comprising honey and the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method; the mass ratio of the raw materials in the honey and the traditional Chinese medicine composition is (1.2-1.5):1.

[0074] In this invention, the mass ratio of the honey to the raw materials in the traditional Chinese medicine composition is (1.3-1.4):1. This invention does not have a specific limitation on the source of the honey; conventional commercially available products are acceptable.

[0075] In this invention, the method for preparing the traditional Chinese medicine honey pills preferably includes the following steps: grinding into powder, mixing with honey, refining honey, adjusting the medicine, and rolling into pills.

[0076] In this invention, the powdering process involves drying the raw materials—sour jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root—and then processing them into a fine powder. This invention does not specifically limit the drying method, but preferably employs gentle roasting or sun-drying. This invention also does not specifically limit the method for producing the fine powder, but preferably uses a powdering machine.

[0077] In this invention, the honey is preferably prepared by mixing Chinese medicinal materials with honey.

[0078] In this invention, the honey refining process involves boiling the honey. First, the honey is brought to a boil over high heat, then simmered over low heat. When the honey develops a yellowish foam, a drop is dipped into the honey using a bamboo chopstick. The chopstick is then placed above a bowl of cold water, allowing the honey to drip into the water. If the honey sinks to the bottom without spreading (i.e., "a drop forms a bead"), the honey is ready.

[0079] In this invention, the preparation of the medicine involves pouring refined honey into a sterilized basin containing medicinal powder using a spoon, while simultaneously stirring the powder with coarse bamboo chopsticks. Honey is added and mixed with the powder until the dry powder is barely visible. In this invention, the pill-making process can be performed using conventional methods. A small amount of glycerin, sesame oil, or peanut oil can be applied to the palm before rolling the pills.

[0080] In this invention, the prepared honey pills also include packaging and storage. Preferably, the prepared honey pills are round and smooth in shape, with a dense and moist surface, and no visible fibers or other discolored spots. After the pills sweat and harden on the outside, they are wrapped in waxed paper, cellophane, plastic bags, or wax shells and stored in a cool, dry place. In this invention, the sweating time of the pills is preferably 2 to 5 days, more preferably 3 days.

[0081] The traditional Chinese medicine composition of the present invention and the honey pills prepared therefrom can effectively improve squamous cell carcinoma of the lung and various clinical symptoms caused by it, with significant effects and no side effects.

[0082] The following detailed description, in conjunction with embodiments, illustrates a traditional Chinese medicine composition for treating squamous cell carcinoma of the lung, its preparation method, and its application. However, these descriptions should not be construed as limiting the scope of protection of this invention.

[0083] Example 1

[0084] A traditional Chinese medicine composition for treating squamous cell carcinoma of the lung and its preparation method

[0085] (1) Accurately weigh the following Chinese medicinal materials: 30g of Ziziphus jujuba seed, 20g of ginseng, 15g of dried ginger, 20g of stir-fried Atractylodes macrocephala, 50g of Paeonia lactiflora, 30g of Rehmannia glutinosa, 20g of Trichosanthes kirilowii root, 50g of stir-fried Coix lacryma-jobi, 7g of honey-processed Ephedra sinica, 30g of Poria cocos, 7g of frankincense, 7g of myrrh, 15g of Alpinia oxyphylla, 20g of vinegar-processed tortoise shell, 20g of vinegar-processed turtle shell, 15g of Albizia julibrissin bark, and 10g of prepared licorice root. Compact the mixture, add water to cover the herbs by 2cm, and soak for 20 minutes.

[0086] (2) After soaking the Chinese herbs, bring the decoction to a boil over high heat, then simmer over low heat for 30 minutes to obtain the first decoction and the first dregs.

[0087] (3) Add water to the first dregs obtained above the surface of the medicine by 2cm, bring the liquid to a boil over high heat, and then simmer over low heat for 30 minutes to obtain the second decoction and the second dregs.

[0088] (4) Add water to the second dregs obtained above the surface of the medicine by 2cm, bring the liquid to a boil over high heat, and then simmer over low heat for 20 minutes to obtain the third decoction and the third dregs.

[0089] (5) The first decoction, the second decoction and the third decoction obtained above are mixed to obtain a traditional Chinese medicine composition.

[0090] Example 2

[0091] A honey pill for treating squamous cell carcinoma of the lung and its preparation method

[0092] (1) Accurately weigh the following raw materials: 30g of jujube seed, 20g of ginseng, 15g of dried ginger, 20g of stir-fried atractylodes macrocephala, 50g of white peony root, 30g of prepared rehmannia root, 20g of trichosanthes root, 50g of stir-fried coix seed, 7g of honey-processed ephedra, 30g of poria cocos, 7g of frankincense, 7g of myrrh, 15g of alpinia oxyphylla, 20g of vinegar-processed tortoise shell, 20g of vinegar-processed turtle shell, 15g of albizia bark, and 10g of prepared licorice root. After sun-drying, grind them into fine powder using a grinder.

[0093] (2) Mix the above 245g of medicinal powder with honey in a ratio of 1:1.2;

[0094] (3) To refine honey, first boil it over high heat, then simmer it over low heat. When you find that the honey has yellow foam, dip a bamboo chopstick into the honey and then move the chopstick above a bowl of cold water to let the honey drip into the water. If the honey does not disperse in the water but sinks to the bottom (i.e., "drops form beads"), then you have obtained the refined honey.

[0095] (4) Pour the refined honey into the medicine powder in the sterilized basin with a spoon, and stir the medicine powder with coarse bamboo chopsticks at the same time. Add honey while mixing the medicine powder. Stop adding honey when the dry medicine powder is basically no longer visible.

[0096] (5) When rolling the pills, a small amount of glycerin can be applied to the palm of the hand. Each pill weighs 9g.

[0097] (6) The honey pills are round and smooth in shape, with a dense and moist surface and no visible fibers or other discolored spots. After the pills sweat (3 days) and the surface hardens, they are wrapped in wax paper, cellophane, plastic bags or wax shells and stored in a cool and dry place.

[0098] Example 3

[0099] Treatment of typical case 1

[0100] Mr. Sun, male, 64 years old, visited the outpatient department of the Affiliated Hospital of Changchun University of Traditional Chinese Medicine on July 22, 2021; chief complaint: cough and sputum for two months. Present illness: Two months prior, the patient developed cough and sputum without any obvious cause and sought medical attention at a tertiary hospital. A lung CT scan showed a patchy high-density shadow in the right lower lobe adjacent to the mediastinum, approximately 3.2cm × 2.5cm in size, with unclear demarcation from the mediastinum and pleura, a CT value of approximately 44 HU, and seemingly shallow lobulation at the margin. The contrast-enhanced CT value was approximately 83 HU in the arterial phase and approximately 85 HU in the venous phase. A bronchoscopy was subsequently performed, and the pathological biopsy indicated squamous cell carcinoma of the lung. No treatment was given, and he is now visiting our outpatient department. Current symptoms: cough, white, sticky sputum, small amount, difficult to expectorate, fatigue, shortness of breath, occasional chest tightness, occasional abdominal pain, poor appetite, normal sleep, bowel movements every 2-3 days, dry stool, normal urination.

[0101] Traditional Chinese Medicine diagnosis: Lung accumulation (Yang deficiency and liver stagnation syndrome); Western medicine diagnosis: Squamous cell carcinoma of the lung.

[0102] Sixty doses of the traditional Chinese medicine composition prepared in Example 1 were prepared. Each dose was decocted in water to obtain 300ml of juice. 150ml was taken orally twice a day.

[0103] Follow-up visit on February 23, 2022; Symptoms: occasional cough, no sputum, significant improvement in fatigue, no chest tightness or shortness of breath, good appetite and sleep, normal bowel movements; repeat lung CT scan showed no obvious space-occupying lesion in the paramedian area of ​​the right lower lobe. The patient's symptoms have lessened.

[0104] Example 4

[0105] Treatment of typical case 2

[0106] Mr. Fu, male, 69 years old, first visit January 24, 2022; Chief complaint: recurrent cough and sputum for 1 year. Present illness: One year ago, the patient developed cough and sputum without any obvious cause. He sought medical attention at a tertiary hospital and received antibiotic treatment, but there was no improvement. Gradually, hemoptysis appeared. A lung CT scan showed a lung mass, followed by bronchoscopy. A biopsy revealed squamous cell carcinoma of the lung. He underwent 6 cycles of chemotherapy and 30 cycles of radiotherapy, but his symptoms did not improve significantly. Current symptoms: Cough, sputum, hemoptysis, chest tightness, frequent sighing, shortness of breath on exertion, dry mouth, good appetite, poor sleep, dry stools (every 3-5 days), and difficulty urinating. Tongue and pulse: The tongue is large and dark red with a white, greasy coating; the pulse is wiry and rapid.

[0107] Traditional Chinese Medicine diagnosis: Lung accumulation (Yang deficiency and liver stagnation syndrome); Western medicine diagnosis: Squamous cell carcinoma of the lung.

[0108] Thirty doses of the traditional Chinese medicine composition prepared in Example 2 were used. Each dose was decocted in water to obtain 300ml of juice. 150ml was taken orally twice a day.

[0109] Follow-up visit on May 13, 2022; Symptoms: Occasional cough with small amount of sticky sputum, shortness of breath and chest tightness relieved after activity, appetite and sleep were good, bowel movements were normal. Tongue and pulse: The tongue was large and dark red with a slightly greasy white coating, and the pulse was wiry and thready. Follow-up lung CT scan showed no growth of the pulmonary lesion and no new metastases. The pulmonary tumor did not grow using the herbal composition of this invention, and the patient's clinical symptoms were significantly alleviated.

[0110] Example 5

[0111] Clinical trials and results analysis of the traditional Chinese medicine composition provided by this invention for the treatment of squamous cell carcinoma of the lung.

[0112] 1. Materials and Methods

[0113] 1.1 Research Subjects

[0114] The study subjects were selected from 17 patients diagnosed with squamous cell carcinoma of the lung admitted to the Affiliated Hospital of Changchun University of Traditional Chinese Medicine from July 2020 to July 2022, including 13 males and 4 females; their ages ranged from 44 to 74 years, with a mean age of 63.2 years.

[0115] 1.2 Diagnostic criteria for squamous cell carcinoma of the lung

[0116] 1.2.1 Western Medicine Diagnostic Criteria

[0117] Squamous cell carcinoma of the lung refers to a primary malignant tumor of the lung. Clinical symptoms mainly include cough, sputum production, hemoptysis, and weight loss. Imaging findings primarily include pulmonary nodules and masses. Pathologically, it is identified as squamous cell carcinoma.

[0118] 1.3 Screening Criteria

[0119] Inclusion criteria:

[0120] 1. Patients whose lung CT scan shows a dense mass in the lung and whose pathology suggests squamous cell carcinoma of the lung, or who have the above-mentioned manifestations before lung surgery.

[0121] 2. The patient or their family agrees to receive traditional Chinese medicine treatment.

[0122] 3. Exclude related diseases that may affect the measurement results, such as pulmonary infection, interstitial lung disease, etc.

[0123] Exclusion criteria:

[0124] 1. Patients whose lung CT scans show other signs of disease, making it impossible to diagnose squamous cell carcinoma of the lung.

[0125] 2. Patients need to have a lung CT scan before treatment and need to have a lung CT scan regularly after treatment, with at least one follow-up scan.

[0126] method

[0127] Ten doses of the traditional Chinese medicine composition prepared in Example 1 were administered. Each dose was decocted in water to obtain 300ml of liquid. The decoction was taken orally at a dose of 150ml twice a day for four weeks, with the patient's own treatment effects compared before and after.

[0128] 1.5 Efficacy Criteria

[0129] I. Symptom Observation: Observe the improvement of patients' clinical symptoms, such as cough, phlegm, chest tightness, shortness of breath, fatigue, and loss of appetite, by TCM treatment.

[0130] Assessment criteria: Traditional Chinese medicine symptoms are divided into 4 levels based on clinical observation:

[0131] (0) Asymptomatic

[0132] (1) Mild

[0133] (2) Moderate

[0134] (3) Severe

[0135] Treatment details are recorded based on the occurrence of symptoms.

[0136] Evaluation method: Comparison of total symptom scores before and after treatment (before treatment / after treatment)

[0137] Significant effect: Symptoms disappear, or symptom scores decrease by >= 2 / 3

[0138] Effective: Symptoms are reduced, or the symptom score is reduced by >=1 / 3 and <=2 / 3.

[0139] Ineffective: Symptoms do not improve, or the symptom score decreases by <=1 / 3.

[0140] II. Imaging observation:

[0141] Refer to the 2009 criteria for evaluating the efficacy of treatment for solid tumors

[0142] 1. CR: All lesions disappear completely during the observation period and last for at least 4 weeks.

[0143] 2. PR: During the observation period, the longest diameter of all lesions decreased by more than 30% and lasted for at least 4 weeks.

[0144] 3. PD: During the observation period, the longest diameter of the largest lesion increases by 20%, or the lesion increases by at least 5 mm, or a new lesion appears.

[0145] 4. SD: Lesions that do not meet either PR or PD criteria during the observation period.

[0146] *Note: Judgment is based on the calculation of the maximum long diameter of the lesion.

[0147] 1.6 Results Analysis

[0148] The statistical results of TCM symptom scores are shown in Table 1. Table 1 shows that the total effective rate of the decoction of the TCM composition provided by this invention reached 76.5%. The imaging statistical results are shown in Table 2, with a disease remission rate of 64.7%. It is evident that taking the TCM composition of this invention can effectively improve the symptoms of patients with squamous cell carcinoma of the lung and alleviate the progression of lung squamous cell carcinoma lesions.

[0149] Table 1 Results of Traditional Chinese Medicine Symptom Scores

[0150] Group Joining the group Effective efficient invalid Overall effectiveness (%) Example 1: Oral administration of traditional Chinese medicine 17 5 8 4 76.5

[0151] Table 2 Analysis of Imaging Results

[0152] Group Joining the group CR PR PD SD Disease remission rate (%) Example 1: Oral administration of traditional Chinese medicine 17 2 9 3 3 64.7

[0153] Example 6

[0154] Animal experiments on the efficacy of traditional Chinese medicine combinations

[0155] 1. Drug-containing serum preparations

[0156] Sprague Dawley rats (6-8 weeks old, male) of the specific pathogen-free grade were purchased from Hubei Beiente Biotechnology Co., Ltd., China. They were kept at room temperature with a 12-hour light / dark cycle, five rats per cage, and humidity maintained at 45%–55%. They had free access to food and water. A pharmaceutical solution with a concentration of 0.67 g / mL was prepared by dissolving 6 g of XJSJF in 9 mL of distilled water. The rats were divided into two groups: a drug serum group administered the prepared herbal composition XJSJF (10 g / kg) via tube feeding, and a normal serum group administered an equal volume of physiological saline for three consecutive days. Blood samples were collected 1.5 hours after the last administration. Rats were anesthetized by intraperitoneal injection of 1% sodium pentobarbital at a dose of 45 mg / kg. Blood was collected from the heart by opening the thoracic cavity, and the supernatant serum was aspirated and frozen for later dilution before experimental use.

[0157] 2. Cell Culture

[0158] Human lung epithelial cell line BEAS-2B was cultured in DMEM medium (Procell, China), while human lung cancer cell line SK-MES-1 was cultured in MEM medium (Procell). Both media were supplemented with 10% FBS (Excell Bio, Australia) and 1% penicillin / streptomycin. Cells were cultured in a 37°C cell culture incubator containing 5% CO2.

[0159] 3. CCK-8 detection

[0160] BEAS-2B and SK-MES-1 cells were seeded into 96-well plates (3 × 10⁶ cells per well). 2Cells were then exposed to normal serum or serum containing different concentrations (5%, 10%, 15%, and 20%) of XJSJF and incubated for 72 hours. Untreated cells served as a control. Subsequently, 10 μL of CCK-8 reagent (HYCEZMBIO, China) was added to each well, followed by an additional 2 hours of incubation. Cell viability was then measured by OD. 450nm To determine this, a microplate reader was used for measurement.

[0161] 3. RT-qPCR

[0162] Total RNA from the cells was extracted using TRIzol reagent (Ambion, USA). It was then reverse transcribed into cDNA and used... Real-time quantitative PCR (qPCR) was performed using IIQ RT SuperMix (VAZYME, China). Next, the reaction system was prepared using SYBR Green Master Mix (VAZYME), and detection was performed on a real-time PCR system (ABI, USA). GAPDH mRNA was used as an internal reference. Primer sequences are listed in Table 1.

[0163] Table 1. Primer sequences used in RT-qPCR.

[0164]

[0165] BEAS-2B and SK-MES-1 cells were treated with serum containing XJSJF (5%, 10%, and 20%). Results are shown below. Figure 1 CCK-8 assays showed that SK-MES-1 cell viability was significantly reduced after XJSJF treatment (P < 0.01), and viability decreased with increasing XJSJF concentration, while no effect was observed on BEAS-2B cells. RT-qPCR showed that 20% XJSJF treatment led to downregulation of CCL2, IL1B, IL6, STAT3, and PTGS2 expression in SK-MES-1 cells (P < 0.01).

[0166] Example 7

[0167] To further analyze the mechanism of action of the traditional Chinese medicine composition provided in this invention in treating squamous cell carcinoma of the lung, a network pharmacological study of traditional Chinese medicine and squamous cell carcinoma of the lung was conducted. The specific analytical methods are as follows:

[0168] 1. Database search for disease-related genes

[0169] In Genecards [1] DisGeNET [2] DigSee [3]Genes related to lung squamous cell carcinoma were searched in the database, and after merging and removing duplicates, 2295 disease-related genes were obtained. The results are shown in: Disease Targets\merge_target_disease.csv.

[0170] 2. Search for active ingredients in traditional Chinese medicine

[0171] In HIT [4] TCMSP [5] TCMID [6] The active ingredients of jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root were searched in the database. After merging the search results and deleting duplicates and compounds without Pubchem ID, 907 active ingredients were finally obtained.

[0172] 3. Active ingredient target retrieval

[0173] Based on the Pubchem ID, the target genes corresponding to the active ingredients were retrieved in HIT. After removing active ingredients that did not have target genes in the database, the search results were merged, and finally 1018 target genes corresponding to 226 active ingredients were obtained.

[0174] 4. Screening for differentially expressed genes in lung squamous cell carcinoma

[0175] The transcriptome dataset GSE3268 for lung squamous cell carcinoma was obtained from the GEO database, and limma was used to analyze it. [7] The package performs differential gene screening between the disease group and the control group, with a screening condition of p < 0.05.

[0176] 5. Identification of drug targets for lung squamous cell carcinoma

[0177] Using VennDiagram [8] (Version 1.7.3) The intersection of the disease-related genes, drug active ingredient targets, and differentially expressed genes selected above was obtained, yielding 199 intersection genes.

[0178] 6. PPI Network Construction

[0179] Utilize STRING [9]The database predicted the interactions and interacting proteins of 199 intersecting genes. The selection criteria were: score_cutoff > 0.4 and size_cutoff < 10, resulting in 3370 interaction pairs, which were plotted using Cytoscape software. The core genes in the PPI network were calculated and their intersections were taken using the EPC, MNC, and MCC algorithms in CytoHubba, yielding 11 hub-genes: IL6, IL1B, CCL2, GAPDH, HIF1A, MMP9, STAT3, SRC, JUN, CASP3, and PTGS2.

[0180] 7. Biofunctional enrichment analysis

[0181] Using clusterProfiler

[10] (Version 4.4.2) Perform GO and KEGG enrichment analysis on genes in the PPI network, where P-value < 0.01 is considered a valid enrichment result.

[0182] 8. Screening of candidate genes for molecular docking

[0183] For each active ingredient in traditional Chinese medicine, the target gene was intersected with 199 genes, and the gene with the most intersections was selected as the core component of the drug. Among them, CID: 445154 (Resveratrol) and CID: 5280343 (Quercetin) had significantly more intersection genes than other components, with 65 and 57 intersection genes, respectively.

[0184] Transcriptome and survival data of squamous cell carcinoma of the lung were downloaded from the TCGA database. KM survival analysis was performed on 11 hub genes screened in the PPI network, and CCL2, IL1B and IL6 were found to be independent prognostic factors.

[0185] Subsequently, CCL2, IL1B, and IL6 were selected as candidate genes for molecular docking and were respectively docked with the core active ingredients of traditional Chinese medicine, CID: 445154 (Resveratrol) and CID: 5280343 (Quercetin).

[0186] 9. Molecular docking

[0187] Molecular docking was used to verify the binding affinity between the screened key targets CCL2, IL1B, and IL6 and the core active ingredients CID: 445154 (Resveratrol) and CID: 5280343 (Quercetin). First, the structures of the target proteins were downloaded from the RCSB protein database (http: / / www.pdb.org / ), and the structure files of the active pharmaceutical ingredients in SDF format were downloaded from PubChem. The downloaded protein and drug files were converted to PDBQT format using Open Babel GUI software, and Pymol and Autodock 1.5.6 software were used for ligand removal, dehydration, hydrogen addition, amino acid optimization, and charge calculation of the proteins. 11 Finally, Autodock 1.5.6 was used for molecular docking, and Pymol was used to visualize the docking results.

[0188] result

[0189] 1. Differential gene screening

[0190] See the screening results Figure 2 A total of 4,168 differentially expressed genes were screened.

[0191] 2. Drug targeting genes in lung squamous cell carcinoma

[0192] Taking the intersection of disease-related genes, drug target genes, and differentially expressed genes yields 199 genes, such as... Figure 3 As shown in Table 2, a network diagram of the relationship between 199 genes and active pharmaceutical ingredients was constructed using Cytoscape, as shown in Table 2. Figure 4 .

[0193] Table 2. 199 target genes of drugs targeting lung squamous cell carcinoma.

[0194]

[0195]

[0196] 3. PPI Network Construction

[0197] Interacting proteins of intersecting genes were predicted using the STRING database, and a PPI network diagram was constructed using Cytoscape, such as... Figure 5 .like Figure 6 and Figure 7 The core genes in the PPI network were calculated and their intersection was taken using the EPC, MNC, and MCC algorithms in CytoHubba, resulting in 11 hub genes: IL6, IL1B, CCL2, GAPDH, HIF1A, MMP9, STAT3, SRC, JUN, CASP3, and PTGS2.

[0198] 4. Results of biological function analysis

[0199] In the GO enrichment analysis, a total of 1610 results were enriched. The top 10 results, filtered by pvalue, are shown below (see...). Figure 8 In the KEGG pathway enrichment analysis, there were 130 signaling pathways. The top 10 results were selected based on the p-value and are shown below (see [link]). Figure 9 ).

[0200] 5. Molecular docking candidate gene analysis

[0201] Intersections were taken between the target genes corresponding to each active ingredient in traditional Chinese medicine and 199 genes (see Table 3). The number of intersecting genes for CID: 445154 (Resveratrol) and CID: 5280343 (Quercetin) was significantly higher than that for other ingredients, with 65 and 57 intersecting genes, respectively.

[0202] Table 3. Intersection results of target genes of active ingredients and 199 genes in drugs (top 10)

[0203]

[0204] Transcriptome and survival data of lung squamous cell carcinoma were downloaded from the TCGA database. KM survival analysis was performed on 11 hub genes screened from the PPI network, revealing that CCL2, IL1B, and IL6 can serve as independent prognostic factors. (See details...) Figure 10 .

[0205] CID: 445154 (Resveratrol) and CID: 5280343 (Quercetin) are the core active ingredients of the drug, which will be used to verify their binding affinity with CCL2, IL1B, and IL6 through molecular docking. These three genes are primarily involved in signaling pathways such as... Figure 11 .

[0206] 6. Molecular docking

[0207] Three selected targets—CCL2, IL1B, and IL6—were subjected to molecular docking with CID: 445154 (Resveratrol) and CID: 5280343 (Quercetin). Binding energies less than -5.0 kcal / mol and the ability to form hydrogen bonds between the acceptor and ligand were used as criteria.

[12] The docking results are shown in Table 4 and... Figures 12-17 .

[0208] Table 4. Results of Molecular Docking

[0209]

[0210] References

[0211] 1. Safran M, Dalah I, Alexander J, et al. GeneCards Version 3: the human gene integrator. Database (Oxford). 2010; 2010: baq020. Published 2010 Aug 5.

[0212] 2. J, Ramirez - Anguita JM, Saüch - Pitarch J, Ronzano F, Centeno E, Sanz F, Furlong LI. The DisGeNET knowledge platform for disease genomics: 2019 update. Nucleic Acids Res. 2020 Jan 8; 48(D1): D845 - D855. doi:10.1093 / nar / akz1021. PMID: 31680165; PMCID: PMC7145631.

[0213] 3. Kim J, So S, Lee HJ, Park JC, Kim JJ, Lee H. DigSee: Disease gene search engine with evidence sentences (version cancer). Nucleic Acids Res. 2013; 41(WebServer issue): W510 - W517. doi:10.1093 / nar / gkt531.

[0214] 4.Yan D,Zheng G,Wang C,Chen Z,Mao T,Gao J,Yan Y,Chen X,Ji X,Yu J,MoS,Wen H,Han W,Zhou M,Wang Y,Wang J,Tang K,Cao Z.HIT 2.0:an enhanced platformfor Herbal Ingredients′Targets.Nucleic Acids Res.2022Jan 7;50(D1):D1238-D1243.doi:10.1093 / nar / gkab1011.PMID:34986599;PMCID:PMC8728248.

[0215] 5.RU J,LI P,WANG J,et.al.TCMSP:a database of systems pharmacology fordrug discovery from herbal medicines[J].J Cheminform,2014,6:13.

[0216] 6.HUANG L,XIE D,YU Y,et.al.TCMID 2.0:a comprehensive resource for TCM[J].Nucleic Acids Res,2018,46(D1):D1117-d1120.

[0217] 7.Ritchie ME,Phipson B,Wu D,et al.limma powers differentialexpression analyses for RNA-sequencing and microarray studies.Nucleic AcidsRes.2015;43(7):e47.doi:10.1093 / nar / gkv007.

[0218] 8.Chen H,Boutros PC.VennDiagram:a package for the generation ofhighly-customizable Venn and Euler diagrams in R0BMC Bioinformatics.2011;12:35.Published 2011Jan 26.

[0219] 9. Szklarczyk D, Gable AL, Nastou KC, et al. The STRING database in 2021: Customizable protein-protein networks, and functional characterization of user-uploaded gene / measurement sets [published correction appears in NucleicAcids Res. 2021 Oct 11; 49(18): 10800]. Nucleic Acids Res.2021;49(D1):D605-D612.

[0220] 10.Yu G, Wang LG, Han Y, He Q Y.clusterProfiler: an R package for comparing biological themes among gene clusters.OMICS.2012;16(5):284-287.

[0221] 11. Seeliger D, de Groot BL. Ligand docking and binding site analysis with PyMOL and Autodock / Vina.J Comput Aided Mol Des. 2010; 24(5): 417-422.

[0222] 12. Feng C, Zhao M, Jiang L, Hu Z, Fan

[0223] Example 8

[0224] The present invention provides a method for optimizing the composition of traditional Chinese medicine raw materials in traditional Chinese medicine compositions.

[0225] The aforementioned traditional Chinese medicine composition was obtained through continuous addition and subtraction of raw materials based on clinical application and summarization of formulas for treating non-small cell lung cancer. The specific process is as follows:

[0226] 1. The formula for treating non-small cell lung cancer includes the following ingredients: 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 10 parts ginseng, 10 parts prepared licorice root, 20 parts Trichosanthes kirilowii root, 20 parts white peony root, 30 parts stir-fried coix seed, 7 parts prepared ephedra, 30 parts Poria cocos, 7 parts frankincense, 7 parts myrrh, 15 parts Alpinia oxyphylla, 15 parts vinegar-processed tortoise shell, 15 parts vinegar-processed turtle shell, 15 parts Albizia julibrissin bark, 10 parts white mustard seed, and 20 parts Patrinia scabiosaefolia.

[0227] Professor Wang Tan applied a formula for treating non-small cell lung cancer to the treatment of squamous cell lung cancer. Through years of clinical observation and summarization, he found that non-small cell lung cancer is often associated with Yang deficiency. Yang deficiency leads to stagnation of Qi, impaired Qi circulation, liver Qi stagnation, failure of the ministerial fire to rise, and lack of support from the sovereign fire, resulting in weakened or impaired command. Abnormal microenvironments such as Qi stagnation, blood stasis, and phlegm-dampness can appear in all five internal organs, limbs, and bones. If the ministerial fire or sovereign fire command is simultaneously weakened or impaired, resulting in local obstruction, coupled with mental and spiritual dysfunction, Yang Qi accumulates and grows abnormally, leading to liver abnormalities. Therefore, the treatment is based on the theory of Yang deficiency and liver stagnation, and mental and spiritual dysfunction. This formula is based on Lizhong Wan, which warms and invigorates Yang and Qi. Combined with Poria cocos, it strengthens the spleen and eliminates dampness, warms and tonifies the middle Jiao, nourishes the earth to generate metal, so that lung Qi can be restored, and pathological products such as phlegm, fluid retention and blood stasis can be reduced or eliminated naturally, changing the microenvironment in the lungs that is suitable for the growth of foreign organisms. The spleen and stomach are the foundation of acquired constitution, which transforms into Ying and Wei. Ying Qi enters the heart and transforms into red, so that the heart is nourished and the spirit is supported. The ministerial fire needs the assistance of the Yang Qi of the middle Jiao to rise. When the middle Jiao is healthy, the ministerial fire can rise smoothly without stagnation. The spleen and stomach govern the function of the pores. Tonifying the spleen and stomach can partially restore the function of the opening and closing of the pores in the site of foreign organisms.

[0228] Patients with Yang deficiency and liver stagnation are more prone to phlegm and blood stasis, and obstruction of the lung meridians. Therefore, white mustard seed is added to warm the lungs, eliminate phlegm, promote Qi circulation, disperse stagnation, and unblock the meridians; trichosanthes root and white peony root are added to nourish Yin and suppress the liver; stir-fried coix seed and alpinia oxyphylla are added to strengthen the spleen and eliminate dampness; frankincense and myrrh are added to invigorate blood and remove blood stasis; vinegar-processed tortoise shell and vinegar-processed turtle shell are added to break up accumulations and eliminate masses; albizia bark is added to nourish the heart and relieve depression, restoring the heart's ability to govern the mind; patrinia scabiosifolia is added to remove blood stasis and drain pus, clearing the stagnation and carbuncles in the lung's abnormal environment; and roasted ephedra is added to guide the medicine into the lung meridian and at the same time unblock the lung meridians.

[0229] 2. Add 20 parts of Ziziphus jujuba seed to the formula for treating non-microcytic lymphoma, forming the following formula 2:

[0230] 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 10 parts ginseng, 10 parts prepared licorice root, 20 parts Trichosanthes kirilowii root, 20 parts white peony root, 30 parts stir-fried coix seed, 7 parts prepared ephedra, 30 parts Poria cocos, 7 parts frankincense, 7 parts myrrh, 15 parts Alpinia oxyphylla, 15 parts vinegar-processed tortoise shell, 15 parts vinegar-processed turtle shell, 15 parts Albizia julibrissin bark, 10 parts white mustard seed, 20 parts Patrinia scabiosaefolia, and 20 parts Ziziphus jujuba seed.

[0231] Professor Wang observed in his clinical practice that lung cancer patients, especially those in the early stages, often experience restlessness, such as intermittent and irregular, brief periods of mental confusion, unexplained sadness, and sleep disturbances. Other symptoms include excessive sweating and chest tightness. Since the function of the mind relies on blood as its material basis, insufficient heart blood cannot nourish the mind, and a clouded mind hinders the flow of vital energy ("the sovereign fire") and the smooth functioning of its functions. Therefore, based on the original prescription, he added jujube seed and albizia bark to nourish the heart and calm the mind. The addition of sour and neutral ingredients further nourishes heart and liver blood, strengthens the heart-nourishing and mind-calming effects, and restores the heart's ability to govern the mind. When the heart is clear, the body is at peace, thus addressing the abnormal environment in the lungs.

[0232] 3. Based on formula 2, increase the amount of ginseng to 20 parts to form formula 3:

[0233] 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 20 parts ginseng, 10 parts prepared licorice root, 20 parts Trichosanthes kirilowii root, 20 parts white peony root, 30 parts stir-fried coix seed, 7 parts prepared ephedra, 30 parts Poria cocos, 7 parts frankincense, 7 parts myrrh, 15 parts Alpinia oxyphylla, 15 parts vinegar-processed tortoise shell, 15 parts vinegar-processed turtle shell, 15 parts Albizia julibrissin bark, 10 parts white mustard seed, 20 parts Patrinia scabiosaefolia, and 20 parts Ziziphus jujuba seed.

[0234] Clinical observations show that patients with pulmonary allergies often present with a deficiency leading to excess, with localized lung lesions primarily caused by the internal retention of Yang Qi in the lower and middle Jiao (the two burners). Damage to the spleen and stomach results in insufficient production of Qi and blood, leading to an imbalance of Qi, blood, Yin, and Yang in the five internal organs and six bowels. Insufficient production of essential substances such as Qi, blood, and body fluids fails to nourish the whole body, causing weakness and fatigue. Professor Wang believes that patients with pulmonary allergies, whose condition is characterized by Yang deficiency and liver stagnation, are even more deficient in constitution and cannot tolerate medication. Clinically, they often present with fatigue, weakness, and reluctance to speak, especially after surgery, radiotherapy, or chemotherapy, when their vital energy is severely depleted. Ginseng in this formula can greatly replenish vital energy, tonify the spleen and lungs, and calm the mind. It is indicated for "insufficient Qi in the five internal organs, five types of overwork and seven types of injury, and weakness and emaciation." However, because modern ginseng is mostly artificially cultivated, 10 parts of ginseng are often insufficient to meet clinical needs. Therefore, the original formula was increased to 20 parts to enhance the tonifying effect of ginseng.

[0235] 4. Based on formula 3, remove the white mustard seeds to form formula 4:

[0236] 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 20 parts ginseng, 10 parts prepared licorice root, 20 parts Trichosanthes kirilowii root, 20 parts white peony root, 30 parts stir-fried coix seed, 7 parts prepared ephedra, 30 parts Poria cocos, 7 parts frankincense, 7 parts myrrh, 15 parts Alpinia oxyphylla, 15 parts vinegar-processed tortoise shell, 15 parts vinegar-processed turtle shell, 15 parts Albizia julibrissin bark, 20 parts Patrinia scabiosaefolia, and 20 parts Ziziphus jujuba seed.

[0237] Clinical observations indicate that patients with Yang deficiency and liver stagnation are more prone to phlegm and fluid retention, and obstructed lung meridians. White mustard seed in this formula is an expectorant that warms the lungs, eliminates phlegm, promotes Qi circulation, disperses stagnation, and unblocks the meridians. However, prolonged use of white mustard seed can cause stomach discomfort, nausea, and even vomiting, especially in patients with weak spleen and stomach, such as after surgery. After careful consideration, Professor Wang decided to remove white mustard seed from this formula to prevent adverse reactions in patients. This herb can be added clinically based on the patient's specific condition.

[0238] 5. Based on formula 4, remove Patrinia scabiosifolia and add 30 parts Rehmannia glutinosa to form formula 5:

[0239] 10 parts dried ginger, 20 parts stir-fried Atractylodes macrocephala, 20 parts ginseng, 10 parts prepared licorice root, and 20 parts Trichosanthes kirilowii root.

[0240] White peony root 20 parts, stir-fried coix seed 30 parts, prepared ephedra 7 parts, poria cocos 30 parts, frankincense 7 parts

[0241] Myrrh 7 parts, Alpinia oxyphylla 15 parts, vinegar-processed tortoise shell 15 parts, vinegar-processed turtle shell 15 parts, Albizia julibrissin bark 15 parts, Ziziphus jujuba seed 20 parts, Rehmannia glutinosa 30 parts.

[0242] After years of research, it is believed that Patrinia scabiosifolia has the effects of removing blood stasis, detoxifying, eliminating carbuncles, and draining pus. However, Patrinia scabiosifolia is a cold herb, and excessive use can easily affect the spleen and stomach, especially for patients with yang deficiency and liver stagnation. Long-term use can easily deplete yang qi, which is inconsistent with the principle of warming yang. Therefore, Patrinia scabiosifolia is removed from the agreed formula. However, in clinical practice, if patients show obvious carbuncles after surgery, Patrinia scabiosifolia may be added to this formula.

[0243] Lung pathogens themselves absorb the essence of the body for their own use, thus the symptoms appear as excess, while the underlying cause is deficiency. Rehmannia glutinosa is an essential herb for nourishing Yin and replenishing essence. In cases of Yang deficiency and liver stagnation, the Yang Qi in the middle Jiao (middle burner) is not flowing smoothly, and the ascending Qi of the Lesser Yang cannot be circulated. However, its essence is often due to deficiency in the lower Jiao (lower burner), insufficient kidney essence to nourish the liver, and insufficient liver blood, which in turn hinders the flow of Yang Qi. Furthermore, the stomach is the gateway to the kidneys. Those with weak spleen and stomach often have insufficient kidney essence, hence Rehmannia glutinosa is used to replenish the innate essence and nourish the acquired essence. Thirdly, those with insufficient Yin essence are susceptible to dampness, therefore Rehmannia glutinosa is used to replenish Yin. It can be combined with Lizhong Wan (a traditional Chinese medicine formula) to dispel dampness, preventing its retention and disrupting the local microenvironment.

[0244] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lung squamous carcinoma, characterized in that, Made from the following parts by weight of raw materials: 20-30 parts of jujube seed, 15-20 parts of ginseng, 10-15 parts of dried ginger, 15-30 parts of stir-fried atractylodes macrocephala, 40-50 parts of white peony root, 20-30 parts of prepared rehmannia root, 15-20 parts of trichosanthes root, 40-50 parts of stir-fried coix seed, 5-7 parts of honey-processed ephedra, 20-30 parts of poria cocos, 5-10 parts of frankincense, 5-10 parts of myrrh, 10-20 parts of alpinia oxyphylla, 20-30 parts of vinegar-processed tortoise shell, 20-30 parts of vinegar-processed turtle shell, 10-20 parts of albizia bark, and 9-12 parts of prepared licorice root.

2. The traditional Chinese medicine composition for treating lung squamous carcinoma according to claim 1, characterized in that, Made from the following parts by weight of raw materials: 30 parts of jujube seed, 20 parts of ginseng, 15 parts of dried ginger, 20 parts of stir-fried atractylodes macrocephala, 50 parts of white peony root, 30 parts of prepared rehmannia root, 20 parts of trichosanthes root, 50 parts of stir-fried coix seed, 7 parts of honey-processed ephedra, 30 parts of poria cocos, 7 parts of frankincense, 7 parts of myrrh, 15 parts of alpinia oxyphylla, 20 parts of vinegar-processed tortoise shell, 20 parts of vinegar-processed turtle shell, 15 parts of albizia bark, and 10 parts of prepared licorice root.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: The following herbs were decocted: jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root. The decoction was then separated to obtain a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The decoction method involves bringing the medicinal liquid to a boil over high heat, then simmering it over low heat.

5. The preparation method according to claim 4, characterized in that, The simmering process involves two to three cycles.

6. The preparation method according to claim 5, characterized in that, The first and second simmering times should be 20-40 minutes each; The third simmering time is 15-25 minutes.

7. The preparation method according to claim 6, characterized in that, Each time you decoct the herbs, the amount of water used should be 2-3 cm above the level of the raw materials or the level of the dregs.

8. The method of any one of claims 3 to 7, wherein the method further comprises the step of: Before decocting, the following ingredients are soaked in water for 15-25 minutes: jujube seed, ginseng, dried ginger, stir-fried atractylodes macrocephala, white peony root, prepared rehmannia root, trichosanthes root, stir-fried coix seed, honey-processed ephedra, poria cocos, frankincense, myrrh, alpinia oxyphylla, vinegar-processed tortoise shell, vinegar-processed turtle shell, albizia bark, and prepared licorice root.

9. The use of the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition obtained by any one of the preparation methods of claims 3 to 8 in the preparation of a medicament for the prevention and / or treatment of squamous cell carcinoma of the lung.

10. A traditional Chinese medicine pill for treating lung squamous carcinoma, characterized in that, The composition comprises honey and the traditional Chinese medicine combination as described in claim 1 or 2, or the traditional Chinese medicine composition obtained by any one of the preparation methods described in claims 3 to 8; The mass ratio of the raw materials in the honey and the traditional Chinese medicine composition is (1.2~1.5):1.

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