Traditional Chinese medicine composition and application thereof in preparation of medicine for treating pulmonary nodule

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and application thereof in preparation of medicines for treating pulmonary nodules. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 30 to 60 parts of rhizoma fagopyri dibotryis, 10 to 20 parts of rhizoma pinelliae, 10 to 30 parts of poria cocos, 5 to 12 parts of liquorice root, 10 to 20 parts of pericarpium citri reticulatae, 10 to 30 parts of radix salviae miltiorrhizae, 10 to 20 parts of radix ranunculi ternati, 10 to 30 parts of radix astragali seu hedysari, 10 to 30 parts of radix codonopsis and 10 to 20 parts of rhizoma atractylodis macrocephalae. The traditional Chinese medicine composition for treating pulmonary nodules is mainly used for reducing phlegm, removing blood stasis, detoxifying and removing stasis, takes qi of lung and spleen as a basic treatment rule, is composed of traditional Chinese medicines for reducing phlegm, removing blood stasis, detoxifying and removing stasis and tonifying lung and spleen, and has a remarkable curative effect on pulmonary nodules.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine. More specifically, it relates to a traditional Chinese medicine composition and its use in the preparation of a drug for treating pulmonary nodules. Background Art

[0002] According to the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2024 Edition)" published by the Lung Cancer Group of the Chinese Medical Association's Respiratory Disease Branch and the Expert Group of the Chinese Lung Cancer Prevention and Control Alliance: "The imaging manifestation of pulmonary nodules is a focal, round-shaped, solid or subsolid shadow with a maximum diameter ≤ 3 cm and increased density compared to the lung parenchyma, which can be solitary or multiple, without atelectasis, hilar lymphadenopathy, and pleural effusion. Solitary pulmonary nodules are mostly asymptomatic, presenting as a soft tissue shadow with clear boundaries, increased density, a maximum diameter ≤ 3 cm, and surrounded by aerated lung tissue." In most cases, smaller pulmonary nodules are asymptomatic. Screening and detailed collection of medical history, such as occupational exposure history, exposure history to endemic fungi, and any history of primary tumors, should be relied on to assist in detection. A few larger pulmonary nodules may have symptoms or signs, such as cough, expectoration, or hemoptysis, or metastatic lymphadenopathy. Multiple pulmonary nodules often present as a single pulmonary nodule accompanied by one or more nodules; generally, diffuse pulmonary nodules with > 10 nodules are mostly caused by metastatic malignant tumors or benign lesions (inflammatory diseases caused by infectious or non-infectious factors).

[0003] In the treatment of pulmonary nodules by traditional Chinese medicine, on the one hand, it relieves stasis, softens hardness, dissipates nodules, expels toxins, controls or reduces pulmonary nodules, and even eliminates nodules. On the other hand, it changes the environment of the patient's lungs, regulates the balance of yin and yang in the body, and prevents the recurrence of nodules. The theoretical systems of traditional Chinese medicine and Western medicine are different, and their methods of preventing and treating diseases are also different, each having its own advantages. Western medicine advocates the treatment of the "cancer" entity. During the "nodule" stage, only observation is possible. During the "cancer" stage, radiotherapy, chemotherapy, and surgery are used. Traditional Chinese medicine, however, targets the cause of "cancer", strengthening the healthy qi and eliminating pathogenic factors, regulating qi and blood, balancing yin and yang, preventing and treating diseases. For the prevention and treatment of pulmonary nodules, traditional Chinese medicine has good efficacy. It differentiates symptoms and signs when there are symptoms, and regulates the constitution when there are no symptoms. It can also regulate the overall physical condition, or the condition after surgery for early or ultra-early lung cancer, or the anxiety state caused by nodules, etc., in order to achieve the purpose of preventing disease before it occurs, preventing the progression of existing disease, and preventing recurrence after recovery.

[0004] Modern medicine mainly focuses on observation and follow-up reexamination for the prevention and treatment of pulmonary nodules. For those with a relatively high probability of malignancy, surgical intervention is carried out. More and more patients with pulmonary nodules seek traditional Chinese medicine treatment. Therefore, combining the advantages of Western medicine imaging and the advantages of traditional Chinese medicine syndrome differentiation and treatment to give full play to the greatest advantages of integrated traditional Chinese and Western medicine in the diagnosis and treatment of pulmonary nodules is also the main way and method for early detection and early treatment of patients with pulmonary nodules. Different doctors, based on the prevention and treatment concepts of traditional Chinese medicine's dynamic view and overall view, adopt different treatment ideas and adjust the compatibility of medicines according to the needs of patients with pulmonary nodules at different stages, and have accumulated rich experience in the treatment of pulmonary nodules. Based on the understanding of the etiology and pathogenesis of pulmonary nodules in traditional Chinese medicine and clinical experience, a traditional Chinese medicine formula guided by a systematic diagnosis and treatment concept will be an effective medicine for the treatment of pulmonary nodules. Summary of the Invention

[0005] The present invention aims to develop a new and effective traditional Chinese medicine composition for the treatment of pulmonary nodules, which can intervene in the treatment of pulmonary nodules at an early stage and has important value for the clinical treatment of pulmonary nodules.

[0006] The purpose of the present invention is to provide a traditional Chinese medicine composition and a preparation method thereof.

[0007] Another purpose of the present invention is to provide the application of the traditional Chinese medicine composition in the preparation of a medicine for the treatment of pulmonary nodules.

[0008] The above objects of the present invention are achieved by the following technical solutions:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition, which comprises the following components in parts by weight: 30 - 60 parts of Fagopyrum dibotrys, 10 - 20 parts of Pinellia ternata, 10 - 30 parts of Poria cocos, 5 - 12 parts of Glycyrrhiza uralensis, 10 - 20 parts of Citrus reticulata Blanco, 10 - 30 parts of Salvia miltiorrhiza, 10 - 20 parts of Ranunculus ternatus Thunb., 10 - 30 parts of Astragalus membranaceus, 10 - 30 parts of Codonopsis pilosula, 10 - 20 parts of Atractylodes macrocephala Koidz.

[0010] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 40 - 50 parts of Fagopyrum dibotrys, 13 - 16 parts of Pinellia ternata, 15 - 25 parts of Poria cocos, 7 - 10 parts of Glycyrrhiza uralensis, 13 - 17 parts of Citrus reticulata Blanco, 12 - 20 parts of Salvia miltiorrhiza, 14 - 18 parts of Ranunculus ternatus Thunb., 15 - 25 parts of Astragalus membranaceus, 15 - 25 parts of Codonopsis pilosula, 13 - 16 parts of Atractylodes macrocephala Koidz.

[0011] Most preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 45 parts of Fagopyrum dibotrys, 15 parts of Pinellia ternata, 20 parts of Poria cocos, 9 parts of Glycyrrhiza uralensis, 15 parts of Citrus reticulata Blanco, 15 parts of Salvia miltiorrhiza, 15 parts of Ranunculus ternatus Thunb., 20 parts of Astragalus membranaceus, 20 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala Koidz.

[0012] The above traditional Chinese medicine composition is decocted and taken, and has a significant curative effect on pulmonary nodules. Therefore:

[0013] Second aspect, the present invention provides a traditional Chinese medicine, which is prepared from the above traditional Chinese medicine composition. Preferably, it is prepared by decocting the above traditional Chinese medicine composition.

[0014] As an alternative embodiment, the specific method of decocting is as follows: Mix the raw materials of each component, add 5 - 8 times the volume of water and soak for 20 - 40 minutes, then boil over high heat until boiling, and decoct over low heat for 10 - 50 minutes to obtain.

[0015] Preferably, soak with 6 - 8 times the volume of water.

[0016] Most preferably, soak with 6 - 7 times the volume of water.

[0017] Preferably, the soaking time is 20 - 30 minutes.

[0018] Most preferably, the soaking time is 25 minutes.

[0019] Preferably, the decocting time over low heat is 20 - 40 minutes.

[0020] Most preferably, the decocting time over low heat is 30 minutes.

[0021] In addition, the traditional Chinese medicine may further include a pharmaceutically acceptable carrier, diluent or excipient to prepare various different dosage forms as required.

[0022] Second aspect, the present invention provides the application of the above traditional Chinese medicine composition or traditional Chinese medicine in the preparation of a drug for treating pulmonary nodules.

[0023] According to the dialectical treatment of traditional Chinese medicine, "deficiency, phlegm, and blood stasis" are the basic pathogenesis of lung nodules; "phlegm and blood stasis" are the main pathological factors of lung nodules; "phlegm toxins and blood stasis toxins" are the key pathogenesis of lung nodules; therefore, "deficiency, phlegm, blood stasis, and toxins" are the core pathogenesis of lung nodules. The treatment principle for lung nodules determined based on the pathogenesis and location should be to treat phlegm, blood stasis, toxins and deficiency together, taking both deficiency and excess into consideration, with resolving phlegm, removing blood stasis, detoxifying and dispersing nodules as the main method, while taking into consideration the qi of the lungs and spleen as the basic treatment principle. The whole prescription should be composed of Chinese medicines that can resolve phlegm, remove blood stasis, detoxify and dispersing nodules and tonify the lungs and invigorate the spleen. In addition, based on the main symptoms and treatment principles, golden buckwheat, which can clear the lungs and resolve phlegm, remove blood stasis and discharge pus, clear away heat and detoxify, invigorate the spleen and eliminate dampness; fight tumors, and enhance the body's immunity, is determined as the main medicine to resolve phlegm, remove blood stasis and detoxify, while pinellia, poria, licorice and tangerine peel are used as auxiliary medicines to assist golden buckwheat in resolving phlegm, removing dampness and removing blood stasis. The main and auxiliary medicines are used to resolve phlegm, remove blood stasis and detoxify, and are assisted by salvia miltiorrhiza and cat's claw to remove blood stasis and disperse nodules, while astragalus, codonopsis and atractylodes are used to adjust the medicinal properties and harmonize the lungs and spleen. Licorice not only harmonizes the medicinal properties of the formula but also possesses multiple pharmacological activities, including anti-tumor, antibacterial, antiviral, anti-inflammatory, immune-modulating, and anti-fibrotic properties. Data mining methods confirmed that "Licorice-Poria-Pinellia" is the most frequently used combination in traditional Chinese medicine formulas for pulmonary nodules, with the highest support and confidence in association rules. It boasts the efficacy of tonifying the lungs and spleen, and removing blood stasis and dampness. The entire formula works together to resolve phlegm, dispel blood stasis, detoxify, and disperse nodules, while also tonifying the lungs and spleen, achieving the goal of treating both the symptom and the root cause of pulmonary nodules.

[0024] The Chinese medicine composition of the present invention uses the following components and raw materials:

[0025] Golden buckwheat is the dried rhizome of Fagopyrum dibotrys (D. Don) Hara, a plant of the Polygonaceae family. Meridian Entrance: Lung Meridian. Properties: Slightly pungent, astringent, cooling. Functions: Clears heat and detoxifies, dispels pus and blood stasis, and clears the lungs and resolves phlegm. It is used for lung abscesses, measles pneumonia, and peritonsillar abscesses.

[0026] Pinellia ternata (Pinellia ternata) Breit., a plant of the Araceae family, is a dried tuber. It enters the spleen, stomach, and lung meridians. Its properties are pungent, warm, and toxic. It primarily dries dampness and resolves phlegm, relieves nausea and vomiting, and dissipates lumps and masses. It is used for cough and asthma caused by excessive phlegm, dizziness and palpitations due to phlegm and fluid retention, dizziness caused by wind and phlegm, headaches caused by phlegm syncope, vomiting and nausea, chest and abdominal distension, and plum pit qi. It can also be used externally in the raw form to treat carbuncles, swellings, and phlegm nodules. Ginger Pinellia ternata is often used to relieve nausea and vomiting.

[0027] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It enters the Heart, Lung, Spleen, and Kidney meridians. Its properties are sweet, mild, and neutral. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0028] Licorice root is the dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. of the Leguminosae family. Meridian tropism: It pertains to the heart, lung, spleen, and stomach meridians. Nature and flavor: Sweet and neutral. Functions and indications: Tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and harmonizing various medicinal herbs. It is used for weakness of the spleen and stomach, lassitude and fatigue, palpitations and shortness of breath, profuse phlegm and cough, spasmodic pain in the abdomen and extremities, carbuncles and sores, and relieving the toxicity and potency of medicinal herbs.

[0029] Tangerine peel is the dried mature pericarp of Citrus reticulata Blanco of the Rutaceae family and its cultivated varieties. Meridian tropism: It pertains to the lung and spleen meridians. Nature and flavor: Bitter, pungent, and warm. Functions and indications: Regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is used for fullness and distension in the chest and epigastrium, anorexia and vomiting or diarrhea, and profuse phlegm and cough.

[0030] Salvia miltiorrhiza is the dried root and rhizome of Salvia miltiorrhiza Bunge. of the Labiatae family. Meridian tropism: It pertains to the heart and liver meridians. Nature and flavor: Bitter and slightly cold. Functions and indications: Removing stasis and alleviating pain, activating blood circulation and dredging meridians, clearing the heart and relieving vexation. It is used for irregular menstruation, amenorrhea and dysmenorrhea, mass in the abdomen, stabbing pain in the chest and abdomen, arthralgia due to heat pathogen, swelling and pain of sores and ulcers, restlessness and insomnia; hepatosplenomegaly, angina pectoris.

[0031] Ranunculus ternatus Thunb. is the dried tuberous root of Ranunculus ternatus Thunb. of the Ranunculaceae family. Meridian tropism: It pertains to the liver and lung meridians. Nature and flavor: Sweet, pungent, and warm. Functions and indications: Resolving masses and reducing swelling. It is used for scrofula not yet ulcerated, lymph node tuberculosis.

[0032] Astragalus root is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family. Meridian tropism: It pertains to the lung and spleen meridians. Nature and flavor: Sweet and warm. Functions and indications: Tonifying qi and consolidating the exterior, inducing diuresis and expelling toxins, discharging pus, and promoting granulation for wound healing. It is used for qi deficiency and weakness, anorexia and loose stools, sinking of qi of the middle-jiao, chronic diarrhea with rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to deficiency of the exterior, qi deficiency edema, difficulty in ulceration of carbuncles and sores, non-healing of long-standing ulcers, sallow complexion due to blood deficiency, internal heat and thirst; proteinuria in chronic nephritis, diabetes mellitus.

[0033] Codonopsis pilosula, the dried root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) L. T. Shen or Codonopsis tangshen Oliv. of the Campanulaceae family. Meridian tropism: Spleen and Lung meridians. Nature and flavor: Sweet, mild. Functions and indications: Tonifying the middle-Jiao and replenishing qi, strengthening the spleen and nourishing the lung. Used for weakness of the spleen and lung, shortness of breath and palpitations, anorexia and loose stools, dyspnea with cough, and internal heat with thirst.

[0034] Atractylodes macrocephala, the dried rhizome of Atractylodes macrocephala Koidz. of the Asteraceae family. Meridian tropism: Spleen and Stomach meridians. Nature and flavor: Bitter, sweet, warm. Functions and indications: Strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and preventing miscarriage. Used for anorexia due to spleen deficiency, abdominal distension and diarrhea, dizziness and palpitation due to phlegm retention, edema, spontaneous sweating, and restlessness during pregnancy. Stir-fried Atractylodes macrocephala with earth strengthens the spleen, harmonizes the stomach, and prevents miscarriage. Used for anorexia due to spleen deficiency, loose stools, and restlessness during pregnancy.

[0035] The present invention has the following beneficial effects:

[0036] The traditional Chinese medicine composition for treating pulmonary nodules in the present invention mainly focuses on resolving phlegm, removing stasis, detoxifying, and dissipating nodules, and takes into account the qi of the lung and spleen as the basic treatment principle. The whole formula is composed of traditional Chinese medicines for resolving phlegm, removing stasis, detoxifying, and dissipating nodules, and tonifying the lung and strengthening the spleen. Fagopyrum dibotrys is determined as the monarch drug, and Pinellia ternata, Poria cocos, Glycyrrhiza uralensis, and Citrus reticulata are used as ministerial drugs to assist Fagopyrum dibotrys in resolving phlegm, removing stasis, and removing dampness. The monarch and ministerial drugs are combined to resolve phlegm, remove stasis, and detoxify. Salvia miltiorrhiza and Nepeta cataria are used as adjuvant drugs to remove stasis and dissipate nodules, and Astragalus membranaceus, Codonopsis pilosula, and Atractylodes macrocephala are used as guiding drugs to regulate the properties of the medicine and harmonize the lung and spleen.

[0037] Through in vivo efficacy evaluation, the traditional Chinese medicine composition for treating pulmonary nodules in the present invention significantly reduces the elevated IFN-γ and IL-12 expressed in the lung tissue of the sarcoidosis granuloma mouse model.

[0038] Through clinical efficacy evaluation, the traditional Chinese medicine composition of the present invention has an effective rate of up to 86.4% for the efficacy determination of lung-RADS of pulmonary nodules, and an effective rate of up to 90.9% for the efficacy determination of traditional Chinese medicine syndromes, significantly reducing the diameter of pulmonary nodules, and the curative effect is remarkable. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 Relative expression levels of IFN-γ and IL-12 in mouse lung tissue. DETAILED DESCRIPTION OF THE INVENTION

[0040] The following further illustrates the present invention in conjunction with the accompanying drawings of the specification and specific embodiments, but the embodiments do not limit the present invention in any form.

[0041] Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in the technical field.

[0042] Unless otherwise specified, the reagents and materials used in the following examples are all commercially available.

[0043] Example 1

[0044] A traditional Chinese medicine composition for treating pulmonary nodules, which is made from the following raw materials in parts by weight: 45 parts of Fagopyrum dibotrys, 15 parts of Pinellia ternata, 20 parts of Poria cocos, 9 parts of Glycyrrhiza uralensis, 15 parts of Citrus reticulata Blanco, 15 parts of Salvia miltiorrhiza, 15 parts of Ranunculus ternatus Thunb., 20 parts of Astragalus membranaceus, 20 parts of Codonopsis pilosula, and 15 parts of Atractylodes macrocephala Koidz.

[0045] The preparation method includes the following steps: Weigh each component of the raw materials, mix the raw materials, soak them in 6 times the volume of water for 25 minutes, then boil them over high heat until boiling, and decoct them over low heat for 30 minutes to obtain the decoction.

[0046] Example 2

[0047] A traditional Chinese medicine composition for treating pulmonary nodules, which is made from the following raw materials in parts by weight: 40 parts of Fagopyrum dibotrys, 13 parts of Pinellia ternata, 15 parts of Poria cocos, 7 parts of Glycyrrhiza uralensis, 13 parts of Citrus reticulata Blanco, 12 parts of Salvia miltiorrhiza, 14 parts of Ranunculus ternatus Thunb., 15 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, and 13 parts of Atractylodes macrocephala Koidz.

[0048] The preparation method includes the following steps: Weigh each component of the raw materials, mix the raw materials, soak them in 6 times the volume of water for 25 minutes, then boil them over high heat until boiling, and decoct them over low heat for 30 minutes to obtain the decoction.

[0049] Example 3

[0050] A traditional Chinese medicine composition for treating pulmonary nodules, which is made from the following raw materials in parts by weight: 50 parts of Fagopyrum dibotrys, 16 parts of Pinellia ternata, 25 parts of Poria cocos, 10 parts of Glycyrrhiza uralensis, 17 parts of Citrus reticulata Blanco, 20 parts of Salvia miltiorrhiza, 18 parts of Ranunculus ternatus Thunb., 25 parts of Astragalus membranaceus, 25 parts of Codonopsis pilosula, and 16 parts of Atractylodes macrocephala Koidz.

[0051] The preparation method includes the following steps: Weigh each component of the raw materials, mix the raw materials, soak them in 6 times the volume of water for 25 minutes, then boil them over high heat until boiling, and decoct them over low heat for 30 minutes to obtain the decoction.

[0052] Comparative Example 1

[0053] Use an equal amount of Fritillaria thunbergii Miq. to replace Fagopyrum dibotrys as the monarch drug, and the others are the same as in Example 1.

[0054] Comparative Example 2

[0055] Use an equal amount of Sinapis alba L. to replace Fagopyrum dibotrys as the monarch drug, and the others are the same as in Example 1.

[0056] Comparative Example 3

[0057] A traditional Chinese medicine composition, which is made from the following raw materials in parts by weight: 45 parts of Fagopyrum dibotrys, 15 parts of Prunella vulgaris, 20 parts of Taraxacum mongolicum, 9 parts of Glycyrrhiza uralensis, 15 parts of Citrus reticulata Blanco, 15 parts of Salvia miltiorrhiza, 15 parts of Ranunculus ternatus Thunb., 20 parts of Astragalus membranaceus (Fisch.) Bunge, 20 parts of Codonopsis pilosula (Franch.) Nannf., and 15 parts of Atractylodes macrocephala Koidz.

[0058] The preparation method includes the following steps: weighing each component of the raw materials, mixing the raw materials of each component, soaking them in 6 times the volume of water for 25 minutes, then boiling them over high heat until boiling, and decocting them over low heat for 30 minutes to obtain the decoction.

[0059] Experimental example 1 Evaluation of in vivo efficacy

[0060] 1. Modeling method

[0061] Pulmonary nodules belong to Th1-type immune disorder diseases, and the expression of IFN-γ and IL-12 will increase in the lung tissue affected by pulmonary nodules. Referring to the method of Swaisgood et al., use C 57 57BL / 6 mice to make a sarcoidosis granuloma animal model (Development of a sarcoidosis murine lung granuloma model using Mycobacterium superoxide dismutase A peptide, Am J Respir Cell Mol Biol, 2011 Feb; 44(2):166-74.), observe the pathological changes of lung tissue and lymph nodes by HE staining, confirm the formation of sarcoidosis-like granulomas, and the modeling is successful.

[0062] 2. Experimental animals

[0063] Select SPF-grade 10-week-old male C 57 57BL / 6 mice, with a body weight of 20-25 g, good fur luster, no hair loss, no trauma or disability, normal limb movement, and good spirit (purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., production license number: SCXK (Beijing) 2016-0006, quality certificate number: NO.1100111911051800.). Adaptively raise them with mouse maintenance feed that meets national standards for one week. Animal breeding conditions: 12 hours of lighting, 12 hours of darkness, breed in a SPF barrier environment, keep the temperature at 21-24 °C, humidity at 40-60%, keep the breeding environment quiet, prevent noise, and allow the animals to eat and drink freely.

[0064] 3. Animal grouping and administration

[0065] The decoctions prepared in Example 1 and Comparative Examples 1-3 were concentrated 3-fold and gavaged to mice once in the morning and once in the evening for 3 consecutive weeks starting from the 15th day of modeling in each group of mice, with a dose of 0.2 mL / 10 g body weight. The control group was gavaged with an equal dose of PBS buffer.

[0066] 4. Result Detection

[0067] The mice were sacrificed, and the total proteins in the lung tissues of each group of mice were extracted to detect the expression levels of IFN-γ and IL-12, with β-actin as the internal reference. The statistical results are as Figure 1 , different lowercase letters indicate significant differences in the IFN-γ expression level (p < 0.05), and different capital letters indicate significant differences in the IL-12 expression level (p < 0.05).

[0068] The results showed that:

[0069] (1) Compared with the control group, the expression levels of IFN-γ and IL-12 in the lung tissues of the sarcoidosis granuloma mouse model were significantly increased.

[0070] (2) Compared with the model group, the traditional Chinese medicine composition for treating lung nodules of the present invention could significantly reduce the expression levels of IFN-γ and IL-12 in the model mice.

[0071] (3) Compared with the model group, there was no significant difference in the IFN-γ expression level in Comparative Examples 1-2, and although the IL-12 expression level decreased significantly, the degree of decrease was less than that in Example 1, and there was still a significant difference compared with Example 1 (p < 0.05), indicating that the change of the monarch drug in Comparative Examples 1-2 seriously damaged the formula principle, affected the synergistic effect and overall balance of the medicinal flavors, and caused a loss of medicinal efficacy.

[0072] (4) Compared with the model group, the expression levels of IFN-γ and IL-12 in Comparative Example 3 both decreased significantly, but the degree of decrease was less than that in Example 1, and there was still a significant difference compared with Example 1 (p < 0.05), indicating that the leading therapeutic effect of the monarch drug also needs to be appropriately assisted by the proper compatibility of ministerial drugs, etc., in order to play properly, and the change of the ministerial drug compatibility also significantly affects the overall therapeutic effect of the formula.

[0073] Test Example 2 Clinical Efficacy Evaluation

[0074] A total of 104 patients with lung nodules, aged 30-55 years, regardless of gender, were diagnosed by lung CT in the outpatient department of the provincial traditional Chinese medicine hospital or the physical examination center, meeting the western medicine diagnostic criteria for small nodules, and the diagnostic criteria referred to the "Chinese Expert Consensus on the Diagnosis and Treatment of Lung Nodules (2018 Edition)". The informed consent form was signed, and they voluntarily participated and cooperated with the follow-up reexamination.

[0075] The 104 patients with lung nodules were divided into five groups, and there were no significant differences in gender, age, lung nodule condition, etc. among the groups, and the course of treatment was 12 weeks.

[0076] High-dose group: Take the decoction prepared in Example 1 once in the morning and once in the evening every day.

[0077] Low-dose group: Take the decoction prepared in Example 1 once a day.

[0078] Comparison group 1: Take the decoction prepared in Comparative Example 1 once in the morning and once in the evening every day.

[0079] Comparison group 2: Take the decoction prepared in Comparative Example 2 once in the morning and once in the evening every day.

[0080] Comparison group 3: Take the decoction prepared in Comparative Example 3 once in the morning and once in the evening every day.

[0081] Table 1 Lung-RADS efficacy criteria

[0082] Efficacy determination Determination criteria Cured The nodules disappeared Marked effect lung-RADS category 3 decreased to category 2 Ineffective The nodule grade did not decrease or even increased

[0083] Total effective rate = (number of cured cases + number of markedly effective cases) / total number of cases * 100%.

[0084] Table 2 Efficacy of lung nodules in lung-RADS

[0085] Group Cured / case Marked effect / case Ineffective / case Effective rate (%) High-dose group 10 9 3 86.4 Low-dose group 5 9 7 66.7* Comparison group 1 4 6 10 50.0*# Comparison group 2 2 8 11 47.6*# Comparison group 3 6 7 7 65.0*

[0086] Compared with the high-dose group, *P < 0.05; compared with the low-dose group, # P < 0.05.

[0087] Table 3 Efficacy criteria for traditional Chinese medicine syndromes (formulated according to the Guidelines for Clinical Research of New Chinese Medicines)

[0088] Efficacy determination Determination criteria Recovery Clinical symptoms and signs disappeared or basically disappeared, and the efficacy index N of syndrome score ≥ 90% Marked effect The clinical symptoms and signs have significantly disappeared, and the curative effect index of the syndrome score is 70% ≤ N < 90% Effective The clinical symptoms and signs have improved, and the curative effect index of syndrome score is 30% ≤ N < 70% Ineffective The clinical symptoms and signs show no obvious improvement or get worse, and the curative effect index of syndrome score N < 30%

[0089] Syndrome score efficacy index = [(score before treatment - score after treatment) / score before treatment] * 100%; effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases * 100%

[0090] Table 4 Efficacy of traditional Chinese medicine syndromes

[0091]

[0092]

[0093] Compared with the high-dose group, *P < 0.05; compared with the low-dose group, # P < 0.05.

[0094] Table 5 Comparison of the maximum diameter of nodules

[0095] Group Before treatment / mm After treatment / mm High-dose group 5.924±0.411 4.176±0.430 Low-dose group 6.120±0.283 5.419±0.476* Comparison group 1 6.007±0.346 5.805±0.517*# Comparison group 2 6.252±0.384 5.931±0.472*# Comparison group 3 6.083±0.425 5.510±0.439*

[0096] *P < 0.05 compared with the high-dose group; compared with the low-dose group, # P < 0.05.

[0097] The high-dose group of the traditional Chinese medicine composition for treating pulmonary nodules in the present invention has a significant therapeutic effect. The effective rate of the lung-RADS efficacy determination for pulmonary nodules is as high as 86.4%, and the effective rate of the traditional Chinese medicine syndrome efficacy determination is as high as 90.9%, significantly reducing the diameter of pulmonary nodules. Although the number of cured cases in the low-dose group is significantly less than that in the high-dose group, the lung-RADS efficacy and the traditional Chinese medicine syndrome efficacy determination of the traditional Chinese medicine composition for treating pulmonary nodules in the present invention still show that it has a good therapeutic effect at low doses. On the contrary, in Comparative Group 1 with fritillaria thunbergii as the monarch drug and Comparative Group 2 with white mustard as the monarch drug, the effective rates of the lung-RADS efficacy and the traditional Chinese medicine syndrome efficacy determination of pulmonary nodules are significantly lower than those of the high-dose group, and even lower than those of the low-dose group. There is basically no difference in the nodule diameter before and after 12 weeks of treatment. In Comparative Group 3 with prunella vulgaris, dandelion, licorice, and tangerine peel as the ministerial drugs, the effective rates of the lung-RADS efficacy and the traditional Chinese medicine syndrome efficacy determination of pulmonary nodules are also significantly lower than those of the high-dose group, and the improvement effect on the nodule diameter is far less than that of the high-dose group.

[0098] The clinical efficacy evaluation is sufficient to show that the present invention uses fagopyrum dibotrys, which clears the lung and resolves phlegm, removes stasis and discharges pus, clears heat and detoxifies, and strengthens the spleen and promotes diuresis, as the monarch drug, which conforms to the core pathogenesis of pulmonary nodules of "deficiency, phlegm, stasis, and toxin", resolves phlegm, removes stasis, detoxifies and dissipates nodules, and takes into account the therapeutic principle of regulating the qi of the lung and spleen. The ministerial drugs are pinellia ternata, poria cocos, licorice, and tangerine peel to assist fagopyrum dibotrys in resolving phlegm and removing stasis. The adjuvant drugs are salvia miltiorrhiza and cat's claw herb to remove stasis and dissipate nodules. The guiding drug is astragalus membranaceus, codonopsis pilosula, and atractylodes macrocephala to regulate the drug properties and harmonize the lung and spleen, and can achieve significant therapeutic effects.

[0099] The above describes the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification is only the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 30-60 parts of Fagopyrum dibotrys, 10-20 parts of Pinellia ternata, 10-30 parts of Poria cocos, 5-12 parts of Glycyrrhiza uralensis, 10-20 parts of Citrus reticulata Blanco, 10-30 parts of Salvia miltiorrhiza, 10-20 parts of Ranunculus ternatus, 10-30 parts of Astragalus membranaceus, 10-30 parts of Codonopsis pilosula, and 10-20 parts of Atractylodes macrocephala Koidz.

2. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition comprises the following components in parts by weight: 40-50 parts of Fagopyrum dibotrys, 13-16 parts of Pinellia ternata, 15-25 parts of Poria cocos, 7-10 parts of Glycyrrhiza uralensis, 13-17 parts of Citrus reticulata Blanco, 12-20 parts of Salvia miltiorrhiza, 14-18 parts of Ranunculus ternatus, 15-25 parts of Astragalus membranaceus, 15-25 parts of Codonopsis pilosula, and 13-16 parts of Atractylodes macrocephala Koidz.

3. The traditional Chinese medicine composition according to claim 2, wherein The traditional Chinese medicine composition comprises the following components in parts by weight: 45 parts of Fagopyrum dibotrys, 15 parts of Pinellia ternata, 20 parts of Poria cocos, 9 parts of Glycyrrhiza uralensis, 15 parts of Citrus reticulata Blanco, 15 parts of Salvia miltiorrhiza, 15 parts of Ranunculus ternatus, 20 parts of Astragalus membranaceus, 20 parts of Codonopsis pilosula, and 15 parts of Atractylodes macrocephala Koidz.

4. A traditional Chinese medicine, characterized in that, It is prepared from the traditional Chinese medicine composition according to any one of claims 1-3.

5. The traditional Chinese medicine according to claim 4, wherein It is prepared by decocting the traditional Chinese medicine composition according to any one of claims 1-3.

6. The traditional Chinese medicine according to claim 5, wherein The decocting method is as follows: after mixing the raw materials of each component, add 5-8 times the volume of water and soak for 20-40 min, then boil over high heat until boiling, and decoct over low heat for 10-50 min to obtain.

7. The traditional Chinese medicine according to claim 6, wherein The soaking time is 20-30 min.

8. The traditional Chinese medicine according to claim 6, wherein The low-heat decocting time is 20-40 min.

9. The traditional Chinese medicine according to any one of claims 4-8, characterized in that, It further comprises a pharmaceutically acceptable carrier, diluent or excipient.

10. Use of the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine according to any one of claims 4-9 in the preparation of a drug for treating lung nodules.

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