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

Abstract

The present application belongs to the technical field of traditional Chinese medicine, 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 medicinal materials: lily, ophiopogon, Zhejiang fritillary bulb, astragalus, curcuma zedoary, lychee kernel, poria, figwort, anemarrhena, and gourd retinervus. The traditional Chinese medicine composition has the effects of benefiting qi and nourishing yin and resolving phlegm and removing stasis, and is particularly suitable for treating small cell lung cancer patients with deficiency of both qi and yin and blood stasis. The traditional Chinese medicine composition has the effects of reducing tumor cell proliferation, regulating tumor immunity, reducing toxicity and increasing efficacy. The traditional Chinese medicine composition can also enhance the immunity of patients, prolong the survival period of patients, and improve the life quality of patients.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Chinese patent application No. 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 this priority document. Technical Field

[0003] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating lung cancer, a preparation method thereof and an application thereof. Background Art

[0004] Lung cancer is one of the most common malignant tumors in my country, with the highest incidence and mortality rates of all malignant tumors, and is the fastest-rising cancer mortality rate in the country. According to the World Health Organization (WHO) lung tumor histological classification, lung cancer can be divided into two major categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Currently, a relatively wide range of treatment options are available for NSCLC, including a multidisciplinary approach encompassing surgery, radiotherapy, chemotherapy, and targeted therapy. SCLC accounts for 15%-20% of primary bronchogenic carcinomas. Compared to NSCLC, SCLC exhibits pathophysiological characteristics such as poor differentiation, high malignancy, and early development of distant metastases. This results in a poor prognosis, with an average five-year survival rate of less than 10%. Unfortunately, research on SCLC has been slow, and clinical treatment options are extremely limited. For a long time, first-line treatment for SCLC has generally been systemic chemotherapy based on platinum-based drugs combined with etoposide. Although SCLC is sensitive to chemotherapy, the vast majority of patients rapidly relapse and die within two years. Finding new treatment strategies to improve the prognosis of SCLC has always been a key focus in SCLC research. In addition, how to more reasonably and effectively integrate 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 (TCM) in treating various benign and malignant tumors has been continuously demonstrated, and its role in the multidisciplinary comprehensive treatment model for malignant tumors has become increasingly important. Extensive and in-depth research on TCM treatment of malignant tumors has also been conducted, and the mechanisms of its effectiveness have gradually been revealed. Although lung cancer is not specifically named in ancient Chinese medical texts, similar descriptions of this condition can be found in numerous ancient texts. Analysis of its onset and clinical features suggests that it falls under the TCM categories of "lung accumulation," "lung carbuncle," "breathing pain," and "piss and pain." There are even more extensive records of similar symptoms and signs of this disease. For example, the "Lingshu" (Lingshu) states: "The lung pulse...is sluggish, with coughing up blood and spitting blood, and pain in the waist, back, and chest." The "Ji Sheng Lun" (Ji Sheng Lun) discusses: "The symptoms of breathing pain...are characterized by qi reversal, back pain, shortness of breath, forgetfulness, blurred vision, abdominal coldness, and occasional pain in the skin, sometimes like lice or like needle pricks." Regarding the etiology and pathogenesis of lung cancer, ancient physicians generally believed that lung cancer is caused by imbalances in the lung meridians, leading to deficiency of yin and yang, qi, and blood. This is closely related to factors such as the invasion of the six exogenous pathogens, infection with pathogenic toxins, internal injury from the seven emotions, overeating, fatigue, insufficient endowment, pre-existing illness, chronic illness, and aging. While there is no unified understanding or summary of the TCM dialectical classification and treatment of lung cancer in ancient Chinese medical texts, a review of the literature reveals that ancient physicians consistently used TCM dialectical classifications of lung cancer based on pathological factors such as deficiency, phlegm, blood stasis, and toxins, and treatments often focused on the lungs, spleen, liver, and kidneys.

[0006] The inventors combined their many years of clinical experience and clinical observation research results to formulate 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 provide a traditional Chinese medicine composition for treating lung cancer, a preparation method thereof and use thereof.

[0008] Specifically, the present invention is achieved 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, 1-30 parts of thunbergia, 1-25 parts of astragalus, 1-25 parts of zedoaria, 1-25 parts of litchi seeds, 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, 5-20 parts of thunbergia, 5-15 parts of astragalus, 5-15 parts of zedoaria, 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, 12 parts of thunbergia, 9 parts of astragalus, 9 parts of zedoaria, 9 parts of litchi seeds, 3 parts of poria, 3 parts of scrophularia, 3 parts of anemarrhena, and 3 parts of luffa.

[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 a 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, thunbergia thunbergii, astragalus, zedoaria, litchi seed, poria, Scrophularia ningpoensis, anemarrhena, and luffa, decocting with water, mixing the filtrate, and concentrating to obtain a concentrated solution.

[0014] As an optional method, in the above preparation method, the decoction is performed twice, the first decoction is performed for 1-3 hours and then filtered to obtain a primary filtrate, the filter residue is then decocted with water for 1-3 hours and filtered to obtain a secondary filtrate, 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 lung cancer of the Qi and Yin deficiency and blood stasis type.

[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 alternative, 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 limited stage.

[0023] As an optional mode, in the above 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 Baihe 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., both of the genus Astragalus in the Leguminosae family. It has a sweet taste and slightly warm properties, and enters the spleen and lung meridians. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting sunken qi, strengthening the exterior defense, promoting urination, and expelling toxins and promoting tissue regeneration. It is primarily used to treat spleen qi deficiency, lung qi deficiency, spontaneous sweating due to qi deficiency, qi and blood deficiency, and ulcers that are difficult to heal or that persist for a long time.

[0030] Curcuma zedoaria is the dried rhizome of Curcuma phaeocaulis Val., Curcuma wangsiensis SGLee et CFLiang, or Curcuma wenyujin YHChen et C.Ling, all members of the Zingiberaceae family. It is warm in nature, pungent and bitter in flavor, and enters the spleen and liver meridians. It promotes qi and resolves blood, dissipates stagnation, and relieves pain. It belongs to the blood-activating and stasis-removing category of herbs. It is used to treat lumps and masses, amenorrhea due to blood stasis, distension and pain caused by food stagnation, and early-stage cervical cancer.

[0031] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is sweet, light, and neutral. It dissipates dampness and promotes diuresis; strengthens the spleen and stomach; and soothes the mind. It can also treat dysuria, edema, cough and reverse phlegm; vomiting; poor appetite due to spleen deficiency; diarrhea; palpitations and restlessness; insomnia and forgetfulness; and turbid spermatorrhea.

[0032] Lily refers to the fleshy scale leaves of Lilium brownii FEBrown var. viridulium baker or Lilium pumilium DC., both of the Liliaceae family. It has a sweet flavor and a cold nature. It enters the Heart and Lung meridians. It nourishes Yin and moistens the lungs, clears the heart and calms the mind. It is primarily used to treat dry coughs caused by Yin deficiency, coughs caused by exertion and hemoptysis, insomnia and palpitations due to Yin deficiency and heat, and internal heat syndromes caused by Yin deficiency in the heart and lungs due to Lily disease.

[0033] Ophiopogon japonicus (Thunb.) Ker-Gawl. (Liliaceae) is a dried root tuber from the Liliaceae family. It is sweet, slightly bitter, and slightly cold. It enters the Heart, Lung, and Stomach meridians. It nourishes Yin and promotes fluid production, moistening the lungs and clearing the heart. It is used for dry coughs caused by lung dryness, coughs due to consumptive consumption, thirst due to loss of fluid, restlessness and insomnia, polydipsia due to internal heat, constipation caused by dry intestines, and diphtheria.

[0034] Scrophularia ningpoensis (Scrophularia ningpoensis Hemsl.) and Scrophularia buergeriana Miq. (S. oldhami Oliv.), both of the Scrophulariaceae family, are dried roots. It has a sweet, slightly bitter, and salty flavor and a slightly cold nature. It enters the lung, stomach, and kidney meridians. It clears heat and cools the blood, purges fire and detoxifies, and nourishes yin. It is primarily used to treat pathogenic warmness invading the Ying meridians, causing pericardial invasion, rashes caused by warm toxins, yin damage caused by febrile illnesses, constipation caused by fluid loss, bone steaming and cough due to fatigue, red eyes and sore throat, scrofula, diphtheria, and carbuncles and sores.

[0035] Fritillaria thunbergii (Fritillaria thunbergii) is a plant of the genus Fritillaria in the Liliaceae family. It has a bitter taste and cold properties, and enters the Lung and Heart meridians. It clears heat and resolves phlegm, dissipates stagnation, and eliminates carbuncles. It is primarily used to treat wind-heat, phlegm-heat cough, scrofula, goiter, mastitis, and lung abscesses.

[0036] Zhimu (Anemarrhena asphodeloides Bge.) is the dried rhizome of Anemarrhena asphodeloides Bge., a plant of the Liliaceae family. It is bitter, sweet, and cold in nature. It enters the lung, stomach, and kidney meridians. It clears heat and purges fire, nourishes yin and moistens dryness. It is primarily used to treat fever-induced thirst, lung-heat-induced dry cough, bone-steaming hot flashes, internal heat-induced polydipsia, and constipation due to intestinal dryness.

[0037] Litchi kernels are the dried, mature seeds of the plant Litchi chinensis Sonn. (Litchi genus, Sapindaceae). They are bitter and astringent, slightly cold in nature, and enter the Heart, Spleen, and Liver meridians. They promote qi circulation, dissipate stagnation, and relieve pain. They are primarily used to treat hernia pain, testicular swelling and pain, chronic epigastric pain, dysmenorrhea, and postpartum abdominal pain.

[0038] Luffa refers to the vascular bundle of the dried, mature fruit of Luffa (Luffa lindrica) Roem. It is sweet and neutral in nature, and enters the lung, stomach, and liver meridians. It dispels wind, dredges the meridians, and promotes blood circulation. It is primarily used to treat rheumatic arthritis, chest and flank pain, milk stagnation, mastitis, traumatic injuries, and chest pain.

[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 composition principle of the Chinese medicine composition of the present invention is as follows: monarch drugs: lily, ophiopogon, thunbergia thunbergii; minister drugs: astragalus, zedoaria, litchi seed; adjuvant drugs: tuckahoe, scrophularia, anemarrhena, luffa.

[0040] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to illustrate 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 experiments were carried out according to the techniques or conditions described in the literature in the field or according to the product instructions. 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] Example 1:

[0045] A traditional Chinese medicine composition for treating lung cancer is prepared from the following raw materials: 12g of lily, 12g of ophiopogon, 12g of thunbergia bulb, 9g of astragalus, 9g of zedoaria, 9g of litchi seed, 3g of poria, 3g of scrophularia, 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, poria, scrophularia, rhizoma anemarrhenae, and luffa, decocting the mixture with water, decocting the mixture twice, wherein the material-liquid ratio of the first decoction and the second decoction are both 1:4, the decoction time of the first decoction and the second decoction are both 1.5 hours, the water used in the first decoction and the second decoction is distilled water, and after decoction, the filtrates are mixed and concentrated under reduced pressure to obtain 200 mL of concentrated solution.

[0047] Example 2:

[0048] A traditional Chinese medicine composition for treating lung cancer is prepared from the following raw materials: 11g of lily, 11g of ophiopogon, 11g of thunbergia thunbergii, 9g of astragalus, 9g of zedoaria, 12g of litchi seed, 3g of poria, 3g of scrophularia, 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, 15g of thunbergia bulb, 9g of astragalus, 9g of zedoaria, 3g of poria, 3g of scrophularia, 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, 12g of thunbergia thunbergii, 9g of astragalus, 9g of zedoaria, 9g of litchi seed, 3g of poria, 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, 12g of thunbergia bulb, 9g of cooked rehmannia, 9g of raw rehmannia, 9g of radix radix angelicae, 3g of white peony root, 3g of liquorice, 3g of platycodon, and 3g of scrophulariae.

[0057] Effect embodiment:

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

[0059] SPF-grade BALB / c female nude mice, 6–8 weeks old and 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 after they were acclimated, they were inoculated with H446 cells, 7x10 7 After one week of inoculation, the left axillary subcutaneous of the nude mice was observed, and it was found that the inoculation site of the nude mice generated a rice-sized nodule. Continue to raise, when the tumor diameter is about 5mm, remove the nude mice with large differences in tumor size and body weight, and randomly divide the remaining nude mice into groups.

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

[0065] Model group: equal volume of normal saline was used for gavage, and the administration method was once a day;

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

[0067] Example 1-2 group and comparative example 1-3 group, respectively, 30mg / kg / day equal volume gavage, once a day.

[0068] Continuous administration for 4 weeks. After 4 weeks, half of the mice in each group were sacrificed, and the tumor mass was stripped. The remaining mice were continued to be administered according to the previous administration scheme, and the survival period of each group was calculated.

[0069] 2.2 Evaluation index

[0070] 2.2.1 Tumor weight and tumor inhibition rate

[0071] After 4 weeks of administration, half of the mice in each group were sacrificed, and the tumor mass was weighed after stripping.

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

[0073] 2.2.2 Survival period

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

[0075] 3. Statistical method

[0076] The results were analyzed by SPSS 27.0 statistical software, and the data were represented as mean ± standard deviation. One-way ANOVA was used for comparison among multiple groups, and t-test was used for comparison between two groups. p<0.05 indicates that the difference is statistically significant.

[0077] 4. Experimental results

[0078] 4.1 Inhibition effect of traditional Chinese medicine composition on tumor-bearing mice in the present application

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

[0080] It can also be seen from the results of the Comparative Examples 1-3 that when the medicinal ingredients in the traditional Chinese medicine composition of the present application are replaced or removed, the effect of the traditional Chinese medicine composition on inhibiting small cell lung cancer in mice is significantly weakened, indicating that the therapeutic effect of the traditional Chinese medicine composition of the present application is closely related to the types of medicinal ingredients in the prescription. In addition, it can be seen from the results of the Comparative Example 3 that the original prescription Baihe Gugong Decoction is not ideal for small cell lung cancer.

[0081] Table 1: Inhibition of the traditional Chinese medicine composition of the present application on tumors of tumor-bearing mice after 4 weeks of administration

[0082]

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

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

[0085] The survival period of tumor-bearing mice is shown in Table 2 below. The results show that the survival period of the mice in the positive control group, the Example 1 group, the Example 2 group and the Comparative Example 1 group were all significantly prolonged, and the survival period of the mice in the Example 1 group and the Example 2 group has already exceeded that of the animals in the positive control group. The reason for this phenomenon may be related to the strong toxicity of the chemotherapeutic drug etoposide itself, which shows that the traditional Chinese medicine composition in the Example 1 group and the 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 the Comparative Examples 1-3 that when the medicinal ingredients in the traditional Chinese medicine composition of the present application are replaced or removed, the effect of the traditional Chinese medicine composition on improving the survival period of tumor-bearing mice is significantly weakened, indicating that the therapeutic effect of the traditional Chinese medicine composition of the present application is closely related to the types of medicinal ingredients in the prescription. In addition, it can be seen from the results of the Comparative Example 3 that the original prescription Baihe Gugong Decoction is not ideal for improving the survival period of tumor-bearing mice with small cell lung cancer.

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

[0088]

[0089]

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

[0091] Furthermore, in the aforementioned animal experiments, no significant panic, anxiety, or food refusal was observed in the nude mice treated with the Chinese herbal composition of the present invention (Example 1 and Example 2). No significant adverse reactions were observed with the Chinese herbal 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 proteins 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 the tumor immune checkpoint protein 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 the positive drug BMS-1018. The various Chinese medicine compositions prepared in the above preparation examples were prepared with DMSO into a buffer solution with a certain concentration gradient, mixed evenly, and added to a 96-well white ELISA plate in 2 mL. After diluting PD-L1 and PD-1 proteins with buffer, add 4 mL to 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 microplate 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 and the regulatory effect of the Chinese medicine composition of the present invention on tumor immunity were evaluated.

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

[0096] Table 3: Regulatory effects of the Chinese medicine composition of the present invention on tumor immunity

[0097]

[0098]

[0099] From the experimental results in Table 3, it can be seen that the regulatory effect of the Chinese medicine composition of the present invention (Example 1 and Example 2) on tumor immunity is comparable 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 may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if such changes and modifications fall within the scope of the claims and their equivalents, the present invention is intended to include such changes and modifications.

Claims

1. A Chinese medicine composition for treating small cell lung cancer, characterized in that: The traditional 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 thunbergia thunbergii, 9 parts of astragalus, 9 parts of zedoaria, 9 parts of litchi seeds, 3 parts of poria, 3 parts of scrophularia, 3 parts of anemarrhena, and 3 parts of luffa. The traditional Chinese medicine composition has the effects of invigorating qi and nourishing yin, and resolving phlegm and dispersing stagnation.

2. The method for preparing the Chinese medicine composition according to claim 1, wherein: The preparation method comprises the following steps: crushing lily, ophiopogon, thunbergia thunbergii, astragalus, zedoaria, litchi seed, tuckahoe, scrophularia, anemarrhena and luffa, adding water for decoction, mixing filtrate and concentrating to obtain concentrated solution.

3. The preparation method according to claim 2, wherein: 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 another 1-3 hours, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined.

4. The preparation method according to claim 3, wherein: The material-liquid ratio of the first decoction and the second decoction was 1:4, the decoction time of the first decoction and the second decoction was 1.5 hours, and the water used in the first decoction and the second decoction was distilled water.

5. Use of the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 2 to 4 in the preparation of a medicament for treating small cell lung cancer.

6. The use according to claim 5, characterized in that: The small cell lung cancer is limited stage small cell lung cancer or extensive stage small cell lung cancer.

7. The use according to claim 5, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

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