Traditional Chinese medicine composition for treating lung cancer as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating lung cancer and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines: lily, radix ophiopogonis, thunberg fritillary bulb, astragalus membranaceus, curcuma zedoary, lychee seed, poria cocos, radix scrophulariae, rhizoma anemarrhenae and loofah sponge. The traditional Chinese medicine composition has the effects of tonifying qi and yin, reducing phlegm and resolving masses, and is particularly suitable for treating a patient suffering from qi-yin deficiency and blood stasis type small cell lung cancer. The traditional Chinese medicine composition disclosed by the invention has the effects of reducing tumor cell proliferation, regulating tumor immunity, reducing toxicity and enhancing efficacy, and can also enhance the immunity of a patient, prolong the lifetime of the patient and improve the living quality of the patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Chinese patent application CN202411715978.6 filed on November 27, 2024, the entire contents of which are incorporated herein by reference. The applicant further declares that the applicant has the right to amend the description and claims of the present invention based on the priority document. Technical Field

[0003] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating lung cancer, a preparation method thereof and uses thereof. Background Art

[0004] Lung cancer is one of the most common malignant tumors in my country. Its morbidity and mortality rate are the highest among all malignant tumors, and it is the cancer with the fastest increasing mortality rate in the Chinese population. According to the histological classification of lung tumors proposed by the World Health Organization (WHO), lung cancer can be divided into two categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). At present, there are relatively many treatment methods for non-small cell lung cancer, and multidisciplinary comprehensive treatment methods including surgery, radiotherapy, chemotherapy, targeted therapy, etc. can be used. Small cell lung cancer accounts for 15%-20% of primary bronchial lung cancer. Compared with non-small cell lung cancer, small cell lung cancer has pathological and physiological characteristics such as low differentiation, high malignancy, and early occurrence of distal metastasis. Its prognosis is poor, and the average five-year survival rate does not exceed 10%. Unfortunately, the research on small cell lung cancer has been slow, and the clinical treatment options are extremely limited. For a long time, the first-line therapy for small cell lung cancer has generally been systemic chemotherapy based on platinum drugs combined with etoposide. Although small cell lung cancer is sensitive to chemotherapy, the vast majority of patients relapse quickly and die within two years. Finding new treatment strategies to improve the prognosis of small cell lung cancer has always been an important topic in the research of small cell lung cancer. In addition, how to more reasonably and effectively use existing treatment methods to improve efficacy and how to better balance efficacy and patient quality of life have become hot topics in current research.

[0005] In recent years, the efficacy of traditional Chinese medicine in treating various benign and malignant tumors has been continuously confirmed, and its position in the multidisciplinary comprehensive treatment model of malignant tumors has become increasingly important. Various studies on the treatment of malignant tumors with traditional Chinese medicine have also been carried out extensively and in depth, and the mechanism of the role of traditional Chinese medicine has gradually been revealed. Although there is no name of lung cancer in ancient Chinese medical books, similar records of this disease can be found in many ancient books and documents. From the analysis of its onset and clinical characteristics, it should belong to the categories of diseases such as "lung accumulation", "lung carbuncle", "breathing pain", and "piss addiction" in traditional Chinese medicine. There are more abundant records of similar symptoms and signs of this disease, such as "Lingshu·Evil Qi Zangfu Disease Form" records: "The lung pulse... is lazy, coughing and spitting blood, and it leads to the waist, back and chest." "Ji Sheng Lun" discusses: "The symptoms of breathing pain... The disease is reversed, back pain and lack of breath, forgetfulness and blindness, cold abdomen and occasional pain in the skin, or like lice, or like needle pricks." Regarding the etiology and pathogenesis of lung cancer, ancient doctors believed that the onset of lung cancer was caused by the imbalance of the lung meridians, the deficiency of yin and yang, qi and blood, and was closely related to factors such as the invasion of the six evils, infection of evil toxins, internal injuries caused by the seven emotions, diet and fatigue, insufficient endowment, chronic diseases, long-term illness, and old age. Although there is no unified understanding and summary of the TCM dialectical typing and treatment of lung cancer in ancient Chinese medical literature, it can be found through the review of literature that the TCM dialectical typing of lung cancer by ancient doctors is inseparable from the pathological factors such as deficiency, phlegm, stasis, and toxins, and the treatment is mostly based on the lungs, spleen, liver, kidneys and other internal organs.

[0006] The inventors have combined their clinical experience and clinical observation research results for many years, formulated the Chinese medicine composition of the present invention on the basis of Baihe Gujin Decoction, and developed a Chinese medicine composition that is particularly suitable for treating patients with Qi and Yin deficiency and blood stasis type small cell lung cancer. Summary of the invention

[0007] The purpose of the present invention is to overcome the deficiencies in the prior art and to provide a Chinese medicine composition for treating lung cancer and a preparation method and use thereof.

[0008] Specifically, the present invention is realized through the following technical solutions:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating lung cancer, which is prepared from the following raw materials in parts by weight: 1-30 parts of lily, 1-30 parts of ophiopogon japonicus, 1-30 parts of thunbergii bulbs, 1-25 parts of astragalus, 1-25 parts of curcuma, 1-25 parts of litchi seed, 1-20 parts of poria, 1-20 parts of scrophularia, 1-20 parts of anemarrhena, and 1-20 parts of luffa.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 5-20 parts of lily, 5-20 parts of ophiopogon japonicus, 5-20 parts of thunbergii bulbs, 5-15 parts of astragalus, 5-15 parts of curcuma, 5-15 parts of litchi seeds, 1-10 parts of poria, 1-10 parts of scrophularia, 1-10 parts of anemarrhena, and 1-10 parts of luffa.

[0011] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 12 parts of lily, 12 parts of Ophiopogon japonicus, 12 parts of Fritillaria thunbergii, 9 parts of Astragalus membranaceus, 9 parts of Curcuma zedoaria, 9 parts of litchi seed, 3 parts of Poria cocos, 3 parts of Scrophularia ningpoensis, 3 parts of Anemarrhena asphodeloides, and 3 parts of Luffa sponge.

[0012] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of invigorating qi and nourishing yin, resolving phlegm and dispersing nodules.

[0013] In the second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect, the preparation method comprising the following steps: crushing lily, ophiopogon, Fritillaria thunbergii, astragalus, zedoaria, litchi seed, poria, Scrophularia ningpoensis, Anemarrhena asphodeloides, and luffa, boiling with water, mixing the filtrate, and concentrating to obtain a concentrated solution.

[0014] As an optional manner, in the above preparation method, the decoction is performed twice, and after the first decoction for 1-3 hours, a primary filtrate is obtained by filtering, the filter residue is further decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering, and the primary filtrate and the secondary filtrate are combined.

[0015] As an optional manner, in the above preparation method, the material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 1.5 hours, and the water used for the first decoction and the second decoction is distilled water; preferably, the concentration is reduced pressure concentration.

[0016] In a third aspect, the present invention provides use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in preparing a drug for treating lung cancer.

[0017] As an optional mode, in the above use, the lung cancer is a Qi and Yin deficiency and blood stasis type lung cancer.

[0018] As an optional mode, in the above use, the lung cancer is small cell lung cancer.

[0019] Preferably, the small cell lung cancer is limited stage small cell lung cancer or extensive stage small cell lung cancer.

[0020] As an optional mode, in the above use, the extensive-stage small cell lung cancer is extensive-stage small cell lung cancer after chemotherapy.

[0021] "Limited-stage small cell lung cancer" refers to tumors confined to one side of the chest cavity, including patients with mediastinal, ipsilateral supraclavicular and anterior scalene lymph node metastases.

[0022] "Extensive-stage small cell lung cancer" refers to the progression of the tumor beyond the localized stage.

[0023] As an optional mode, in the above-mentioned use, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] (1) The Chinese medicine composition of the present invention has the effects of invigorating qi and nourishing yin, resolving phlegm and dispersing nodules, and is particularly suitable for treating patients with qi and yin deficiency and blood stasis type small cell lung cancer, while the original formula of Lily Gujin Decoction can only treat patients with qi and yin deficiency type lung cancer, and its efficacy for patients with small cell lung cancer is poor.

[0026] (2) The Chinese medicine composition of the present invention has the effects of reducing tumor cell proliferation, regulating tumor immunity, reducing toxicity and increasing efficacy. The Chinese medicine composition of the present invention can also enhance the patient's immunity, prolong the patient's survival period, and improve the patient's quality of life.

[0027] (3) The Chinese medicine composition of the present invention is based on the traditional Chinese medicine formula, uses modern preparation technology and is deeply optimized. The preparation method is simple, and the Chinese medicine composition of the present invention can be made into various dosage forms such as granules, tablets, oral liquids or capsules. DETAILED DESCRIPTION

[0028] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0029] Astragalus memeranaceus (Fisch.) Bge. Var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the genus Astragalus in the Leguminosae family. It is sweet in taste and slightly warm in nature. It enters the spleen and lung meridians. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, strengthening the body's defense system, promoting urination, and removing toxins and promoting muscle growth. It is mainly used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal for a long time, etc.

[0030] "Ezhu" is the dried rhizome of the ginger family plants Curcumaphaeocaulis Val., Curcumakwangsiensis SGLee et CFLiang or Curcuma wenyujin YHChen et C.Ling. It is warm in nature, pungent and bitter in taste. It enters the spleen and liver meridians. It promotes qi and resolves blood, eliminates stagnation and relieves pain. It belongs to the blood-removing and stagnation-removing medicine under the category of blood-activating and stasis-removing medicine. It is used to treat stagnation and lumps, blood stasis and amenorrhea, food stagnation and pain, and early cervical cancer.

[0031] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is sweet, light and neutral. It can dissipate dampness and promote diuresis; invigorate the spleen and stomach; soothe the mind and calm the nerves. It can also cause urination problems; edema; cough and reverse phlegm; vomiting; poor appetite due to spleen deficiency; diarrhea; palpitations and restlessness; insomnia and forgetfulness; and leukorrhea.

[0032] Lily is the fleshy scale leaf of Lilium brownii FEBrown var.viriduliumbaker or Lilium pumilium DC. of the Liliaceae family. It is sweet and cold in nature. It enters the heart and lung meridians. It has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind. It is mainly used to treat dry cough due to yin deficiency, cough due to fatigue and hemoptysis, insomnia and palpitations due to yin deficiency and heat, and lily disease syndrome of heart and lung yin deficiency and internal heat.

[0033] "Maidong" is the dried root of Ophiopogon japonicus (Thunb.) Ker-Gawl., a plant of the Liliaceae family. It is sweet, slightly bitter, and slightly cold. It enters the heart, lung, and stomach meridians. It nourishes yin and produces body fluid, moistens the lungs and clears the heart. It is used for dry cough due to lung dryness, cough due to consumptive tuberculosis, thirst due to loss of body fluid, restlessness and insomnia, internal heat and thirst, dry intestines and constipation, and diphtheria.

[0034] "Scrophularia" is the dried root of Scrophularia ningpoensis Hemsl. and Scrophularia buergeriana Miq. [S.oldhami Oliv.] of the Scrophulariaceae family. It tastes sweet, slightly bitter, and salty, and is slightly cold in nature. It enters the lung, stomach, and kidney meridians. It has the effects of clearing heat and cooling blood, purging fire and detoxifying, and nourishing yin. It is mainly used to treat warm pathogens entering the camp, internal pericardium, warm toxicity causing spots, febrile disease damaging yin, body fluid damage causing constipation, bone steaming and fatigue cough, red eyes and sore throat, scrofula, diphtheria, carbuncle, swelling, and sore.

[0035] "Fritillaria thunbergii" is the bulb of Fritillaria thunbergii Miq., a plant of the genus Fritillaria in the Liliaceae family. It tastes bitter and is cold in nature. It enters the lung and heart meridians. It has the effects of clearing away heat and resolving phlegm, dispersing stagnation and eliminating carbuncle. It is mainly used to treat wind-heat, cough due to phlegm heat, scrofula, goiter, breast carbuncle, and lung carbuncle.

[0036] "Anemarrhena" is the dried rhizome of Anemarrhena asphodeloides Bge., a plant of the genus Anemarrhena in the Liliaceae family. It is bitter, sweet and cold in nature. It enters the lung, stomach and kidney meridians. It has the effects of clearing away heat and purging fire, nourishing yin and moistening dryness. It is mainly used to treat fever, thirst, lung heat and dry cough, bone steaming and tidal fever, internal heat and thirst, and intestinal dryness and constipation.

[0037] "Lychee kernel" is the dried mature seed of Litchi chinensis Sonn., a plant of the Sapindaceae family. It tastes bitter and astringent, is slightly cold in nature, and enters the heart, spleen, and liver meridians. It has the effects of promoting qi and dispersing stagnation, dispersing cold and relieving pain. It is mainly used to treat hernia pain, testicular swelling and pain, chronic stomach pain, dysmenorrhea, and postpartum abdominal pain.

[0038] "Luffa" is the vascular bundle of the dried mature fruit of Luffa (L.) Roem., a plant of the Cucurbitaceae family. It is sweet and neutral in nature, and enters the lung, stomach, and liver meridians. It has the effects of dispelling wind, unblocking meridians, and activating blood circulation. It is mainly used to treat rheumatic arthralgia, chest and flank pain, milk obstruction, mastitis, traumatic injury, chest pain, etc.

[0039] The therapeutic principle of the Chinese medicine composition of the present invention is to invigorate qi and nourish yin, resolve phlegm and dissipate stagnation. The prescription principle of the Chinese medicine composition of the present invention is as follows: monarch medicine: lily, ophiopogon, thunbergia thunbergii; minister medicine: astragalus, zedoaria, litchi seed; adjuvant medicine: tuckahoe, scrophularia, rhizoma anemarrhenae, luffa.

[0040] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0041] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0042] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0043] Preparation Example:

[0044] Embodiment 1:

[0045] A traditional Chinese medicine composition for treating lung cancer, the traditional Chinese medicine composition is prepared from the following raw materials: 12g of lily, 12g of ophiopogon japonicus, 12g of thunbergii bulb, 9g of astragalus, 9g of curcuma, 9g of litchi seed, 3g of tuckahoe, 3g of scrophulariae, 3g of anemarrhena, and 3g of luffa.

[0046] The preparation method of the traditional Chinese medicine composition comprises the following steps: crushing lily, ophiopogon, fritillaria thunbergii, astragalus, zedoaria, litchi seed, tuckahoe, scrophularia, rhizoma anemarrhenae and luffa, adding water for decoction, decoction twice, the material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 1.5 hours, the water used for the first decoction and the second decoction is distilled water, mixing the filtrate after decoction, and concentrating under reduced pressure to obtain 200 mL of concentrated solution.

[0047] Embodiment 2:

[0048] A traditional Chinese medicine composition for treating lung cancer, the traditional Chinese medicine composition is prepared from the following raw materials: 11g of lily, 11g of ophiopogon japonicus, 11g of thunbergii bulb, 9g of astragalus, 9g of curcuma, 12g of litchi seed, 3g of tuckahoe, 3g of scrophulariae, 3g of anemarrhena, and 3g of luffa.

[0049] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0050] Comparative Example 1:

[0051] A traditional Chinese medicine composition is prepared from the following raw materials: 15g of lily, 15g of ophiopogon japonicus, 15g of fritillaria thunbergii, 9g of astragalus, 9g of zedoaria, 3g of tuckahoe, 3g of scrophulariae, 3g of anemarrhena, and 3g of luffa.

[0052] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0053] Comparative Example 2:

[0054] A traditional Chinese medicine composition is prepared from the following raw materials: 12g of lily, 12g of ophiopogon japonicus, 12g of thunbergii bulb, 9g of astragalus, 9g of zedoaria, 9g of litchi seed, 3g of tuckahoe, 3g of scrophularia, 3g of anemarrhena, and 3g of scutellaria barbata.

[0055] Comparative Example 3:

[0056] A traditional Chinese medicine composition is prepared from the following raw materials: 12g of lily, 12g of ophiopogon japonicus, 12g of fritillaria thunbergii, 9g of cooked rehmannia, 9g of raw rehmannia, 9g of radix radix angelicae, 3g of white peony root, 3g of liquorice, 3g of platycodon grandiflorum, and 3g of scrophularia ningpoensis.

[0057] Effect embodiment:

[0058] Effect Example 1: Effect of the Chinese medicine composition of the present invention on H446 mouse transplanted tumor model 1. Main experimental animals and experimental materials

[0059] SPF BALB / c female nude mice, 6-8 weeks old, weighing 18-22 g, were purchased from the Experimental Animal Center of Heilongjiang University of Chinese Medicine.

[0060] Human small cell lung cancer cell line H446 was purchased from the cell bank of the Chinese Academy of Medical Sciences; etoposide injection (20 mg / mL) was purchased from Qilu Pharmaceutical.

[0061] 2. Experimental Methods

[0062] 2.1 Establishment of transplanted tumor model and drug administration

[0063] BALB / c female nude mice were raised at room temperature and inoculated with H446 cells after they adapted to the environment. Each nude mouse was injected with 7×10 7 One week after inoculation, the nude mice were observed under the skin of the left armpit and rice-sized nodules were found at the inoculation site. The mice were kept until the tumor diameter was about 5 mm, and the nude mice with large differences in tumor size and weight were removed, and the remaining nude mice were randomly divided into groups.

[0064] This experiment was divided into the following groups, with 12 tumor-bearing mice in each group:

[0065] Model group: The mice were gavaged with an equal volume of normal saline once a day;

[0066] Positive control group: etoposide, 2 mg / kg / day, intraperitoneal injection in equal volume, once a day;

[0067] The Example 1-2 group and the Comparative Example 1-3 group were intragastrically administered with an equal volume of 30 mg / kg / day, once a day.

[0068] The drug was administered continuously for 4 weeks. After 4 weeks, half of the mice in each group were killed and the tumor masses were removed. The remaining mice continued to receive the drug according to the previous dosing regimen, and the survival time of each group was calculated.

[0069] 2.2 Evaluation indicators

[0070] 2.2.1 Tumor weight and tumor inhibition rate

[0071] After 4 weeks of administration, half of the mice in each group were killed, and the tumors were removed and weighed.

[0072] Tumor inhibition rate (%) = (average tumor weight of model group - average tumor weight of drug administration group) / average tumor weight of model group × 100%

[0073] 2.2.2 Lifetime

[0074] When evaluating survival, tumor-bearing animals that were in a moribund state were euthanized for animal welfare considerations.

[0075] 3. Statistical methods

[0076] The results were analyzed using SPSS 27.0 statistical software, and the data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and t-test was used for comparison between two groups. P < 0.05 indicated statistically significant differences.

[0077] 4. Experimental Results

[0078] 4.1 Inhibitory effect of the Chinese medicine composition of the present invention on tumors in tumor-bearing mice

[0079] In the experiment, after nude mice were inoculated with H446 cells, the tumors grew rapidly after a 5-day incubation period. As shown in Table 1 below, the results showed that the tumors of mice in the positive control group, Example 1 group, and Example 2 group were significantly inhibited (*p<0.05, **p<0.01), and the effect of Example 1 group was close to that of the positive control drug etoposide.

[0080] It can also be seen from the results of comparative examples 1-3 that when the medicinal flavors in the Chinese medicine composition of the present invention are replaced or removed, the effect of the Chinese medicine composition in inhibiting small cell lung cancer in mice is significantly weakened, indicating that the efficacy of the Chinese medicine composition of the present invention is closely related to the types of medicinal flavors in the prescription. In addition, it can be seen from the results of comparative example 3 that the effect of the original formula of Lily Solid Gold Decoction on small cell lung cancer is not ideal.

[0081] Table 1: Inhibitory effect of the Chinese medicine composition of the present invention on tumors in tumor-bearing mice 4 weeks after administration

[0082]

[0083] Note: *p<0.05, **p<0.01, compared with the model group.

[0084] 4.2 Effect of the Chinese medicine composition of the present invention on the survival period of tumor-bearing mice

[0085] The survival results of tumor-bearing mice are shown in Table 2. The results show that the survival of mice in the positive control group, Example 1 group, Example 2 group, and Comparative Example 1 group was significantly prolonged, and the survival of mice in Example 1 group and Example 2 group exceeded that of the positive control group. The reason for this phenomenon may be related to the strong toxicity of the chemotherapy drug etoposide itself, which shows that the Chinese medicine composition of Example 1 group and Example 2 group may be superior to the positive control drug in terms of safety.

[0086] It can also be seen from the results of comparative examples 1-3 that when the medicinal flavors in the Chinese medicine composition of the present invention are replaced or removed, the improvement effect of the Chinese medicine composition on the survival of tumor-bearing mice is significantly weakened, indicating that the efficacy of the Chinese medicine composition of the present invention is closely related to the types of each medicinal flavor in the prescription. In addition, it can be seen from the results of comparative example 3 that the original formula of Lily Solid Gold Decoction does not have a very obvious effect on improving the survival of mice bearing small cell lung cancer.

[0087] Table 2: Effect of the Chinese medicine composition of the present invention on the survival period of tumor-bearing mice

[0088]

[0089]

[0090] Note: *p<0.05, **p<0.01, compared with the model group.

[0091] In addition, in the above animal experiments, no obvious panic, anxiety or anorexia was found in the nude mice of the Chinese medicine composition group (Example 1 group and Example 2 group) of the present invention. No obvious adverse reactions were observed in the Chinese medicine composition of the present invention, and the experimental animals had good tolerance to it.

[0092] Effect Example 2: Effect of the Chinese medicine composition of the present invention on the interaction between tumor immune checkpoint protein PD-L1 / PD-1

[0093] The kit is used to detect the inhibitory activity of the Chinese medicine composition of the present invention on the interaction of tumor immune checkpoint proteins PD-L1 / PD-1, thereby detecting the regulatory effect of the Chinese medicine composition of the present invention on tumor immunity.

[0094] Tumor immune escape is a basic characteristic of malignant tumors. Tumor cells highly express immune checkpoints such as PD-L1 and other proteins on their surface. When they bind to proteins such as PD-1 on the surface of cytotoxic T lymphocytes, the T lymphocytes will be relieved of immune surveillance and immune-mediated killing of tumor cells, which is the immune escape mechanism. Purchase a PD-L1 kit (Cisbio PD-1 / PD-L1 binding assay kit), containing reagents such as anti-tag1-Eu, anti-tag2-XL665, and detection buffer, and positive drug BMS-1018. The various Chinese medicine compositions prepared in the above preparation examples are formulated into a buffer solution with a certain concentration gradient with DMSO, mixed evenly, and added to a 96-well white ELISA plate. After diluting PD-L1 and PD-1 proteins with buffer, add 4 mL to the wells of a 96-well white ELISA plate. After incubation for 15 minutes, add anti-tag1-Eu, anti-tag2-XL665, and detection buffer. After incubation at room temperature for 2 hours, use a Tecan Infinite F200 ELISA reader to detect the fluorescence signals at 665 nm and 620 nm. Calculate the inhibition rate of PD-L1 / PD-1 binding based on the fluorescence ratio value, and calculate the IC 50 The value was determined and the regulatory effect of the Chinese medicine composition of the present invention on tumor immunity was evaluated.

[0095] The experimental results are shown in Table 3.

[0096] Table 3: The regulatory effect of the Chinese medicine composition of the present invention on tumor immunity

[0097]

[0098]

[0099] It can be seen from the experimental results in Table 3 that the regulatory effect of the Chinese medicine composition of the present invention (Example 1 and Example 2) on tumor immunity is equivalent to that of the positive control drug.

[0100] It can also be seen from the results of comparative examples 1-3 that when the medicinal flavors in the traditional Chinese medicine composition of the present invention are replaced or removed, the regulatory effect of the traditional Chinese medicine composition on tumor immunity is weakened, indicating that the therapeutic effect of the traditional Chinese medicine composition of the present invention is closely related to the types of medicinal flavors in the prescription.

[0101] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating lung cancer, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-30 parts of lily, 1-30 parts of ophiopogon japonicus, 1-30 parts of thunbergii bulbs, 1-25 parts of astragalus, 1-25 parts of zedoaria, 1-25 parts of litchi seeds, 1-20 parts of tuckahoe, 1-20 parts of scrophulariae, 1-20 parts of anemarrhena, and 1-20 parts of luffa.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-20 parts of lily, 5-20 parts of ophiopogon, 5-20 parts of thunbergii, 5-15 parts of astragalus, 5-15 parts of zedoaria, 5-15 parts of litchi seeds, 1-10 parts of tuckahoe, 1-10 parts of scrophularia, 1-10 parts of anemarrhena, and 1-10 parts of luffa.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of lily, 12 parts of ophiopogon, 12 parts of thunbergii, 9 parts of astragalus, 9 parts of zedoaria, 9 parts of litchi seeds, 3 parts of tuckahoe, 3 parts of scrophularia, 3 parts of anemarrhena, and 3 parts of luffa.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition has the effects of invigorating qi and nourishing yin, resolving phlegm and dispersing stagnation.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method comprises the following steps: crushing lily, ophiopogon, fritillaria thunbergii, astragalus, zedoaria, litchi seed, tuckahoe, scrophularia, rhizoma anemarrhenae and luffa, adding water for decoction, mixing filtrate and concentrating to obtain concentrated solution.

6. The preparation method according to claim 5, characterized in that: The decoction is performed twice. After the first decoction for 1-3 hours, a primary filtrate is obtained by filtering. The filter residue is then decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined.

7. The preparation method according to claim 6, characterized in that: The material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 1.5 hours, and the water used in the first decoction and the second decoction is distilled water; preferably, the concentration is reduced pressure concentration.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 7 in preparing a drug for treating lung cancer.

9. The use according to claim 8, characterized in that: The lung cancer is small cell lung cancer. Preferably, the small cell lung cancer is limited stage small cell lung cancer or extensive stage small cell lung cancer.

10. The use according to claim 8, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

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