A traditional Chinese medicine composition for treating lung nodules and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating pulmonary nodules and its application, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition of this invention comprises the following components: *Hedyotis diffusa*, *Hedyotis diffusa*, *Fritillaria thunbergii*, *Lobelia chinensis*, *Sinapis alba*, *Morus alba* leaf, *Perilla frutescens* leaf, *Citrus medica*, *Pogostemon cablin*, *Laminaria japonica*, *Prunus mume*, *Glycyrrhiza uralensis*, *Chrysanthemum morifolium*, *Lonicera japonica*, and *Rosa rugosa*. This traditional Chinese medicine composition can effectively improve symptoms such as dry cough, wheezing, shortness of breath, and chest tightness in patients with pulmonary nodules; it also takes into account the regulation of the spleen, stomach, and liver, avoiding the gastrointestinal discomfort and heavy burden caused by oral medications, and avoiding potential liver and kidney damage caused by medication.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating pulmonary nodules and its application. Background Technology

[0002] Pulmonary nodules are focal, roundish shadows with a diameter ≤3 cm on lung imaging, exhibiting increased density compared to the lung parenchyma. Whether benign or malignant, large or numerous, pulmonary nodules occupy lung space, compress surrounding normal lung tissue, and impair lung ventilation and gas exchange. Patients may experience symptoms such as dyspnea and shortness of breath, especially after activity, thus affecting daily life and work. Their formation is complex, primarily related to infection, inflammation, environmental pollution, and genetic factors. Western medicine lacks specific drugs for treating pulmonary nodules, and surgical resection has clinical limitations such as high invasiveness and a high risk of postoperative complications. Traditional Chinese medicine classifies pulmonary nodules under the category of "pulmonary accumulation." "Pulmonary accumulation" is one of the "five accumulations" in TCM. The *Nan Jing* (Classic of Difficult Issues), in its 56th chapter, states, "The accumulation of the lung is called *xi ben*," referring to the stagnation and accumulation of pathogenic factors in the lungs. Today, it is often used to refer to diseases such as pulmonary nodules and lung cancer. The formation of pulmonary nodules is closely related to factors such as insufficient vital energy, invasion of external pathogens, emotional imbalance, and stagnation of phlegm and blood stasis. Its essence is the abnormal circulation of qi, blood and body fluids in the human body, which leads to the accumulation of local pathological products, often involving dysfunction of organs such as the lungs, spleen, kidneys and liver.

[0003] Although Traditional Chinese Medicine (TCM) has conducted some research on pulmonary nodules, no effective TCM formulas with clearly defined mechanisms of action have been reported, and there are currently no mature therapeutic drugs available clinically. Therefore, current clinical prescriptions suffer from insufficient patient experience, significant biases, and arbitrary extraction processes, making it difficult to guarantee the consistency of effective components and thus failing to meet general treatment needs. Some prescriptions even use cold-natured herbs, which may exacerbate nodule formation. Therefore, developing relevant drugs with definite therapeutic effects is an urgent clinical problem to be solved. Summary of the Invention

[0004] In order to solve the problems existing in the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating pulmonary nodules and its application. It mainly targets pulmonary nodules caused by external wind-evil, blood stasis and internal obstruction, and damp-heat inflammation, while also taking into account the conditioning of the spleen, stomach and liver. It can avoid the gastrointestinal discomfort and heavy burden caused by oral medication, and avoid the liver and kidney damage that may be caused by taking medication.

[0005] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A traditional Chinese medicine composition for treating pulmonary nodules is provided, comprising the following components in parts by weight: 1.0-10.0 parts of Hedyotis diffusa, 1.0-10.0 parts of Hedyotis diffusa, 1.0-10.0 parts of Fritillaria thunbergii, 1.0-10.0 parts of Lobelia chinensis, 1.0-8.0 parts of Sinapis alba, 1.0-8.0 parts of Morus alba leaf, 1.0-8.0 parts of Perilla frutescens leaf, 1.0-8.0 parts of Citrus medica, 1.0-8.0 parts of Pogostemon cablin, 1.0-8.0 parts of Laminaria japonica, 1.0-8.0 parts of Prunus mume, 1.0-8.0 parts of Glycyrrhiza uralensis, 1.0-8.0 parts of Chrysanthemum morifolium, 0.5-6.0 parts of Lonicera japonica, and 0.5-6.0 parts of Rosa rugosa.

[0006] Furthermore, the traditional Chinese medicine composition comprises the following components in parts by weight: 2.0-3.0 parts of Hedyotis diffusa, 2.0-3.0 parts of Hedyotis diffusa, 2.0-3.0 parts of Fritillaria thunbergii, 2.0-3.0 parts of Lobelia chinensis, 1.5-2.5 parts of Sinapis alba, 1.5-2.0 parts of Morus alba leaf, 1.5-2.0 parts of Perilla frutescens leaf, 1.5-2.0 parts of Citrus medica, 1.5-2.0 parts of Pogostemon cablin, 1.5-2.0 parts of Laminaria japonica, 1.5-2.0 parts of Prunus mume, 1.5-2.0 parts of Glycyrrhiza uralensis, 1.5-2.0 parts of Chrysanthemum morifolium, 1.0-1.5 parts of Lonicera japonica, and 0.8-1.2 parts of Rosa rugosa.

[0007] Furthermore, the traditional Chinese medicine composition includes the following components in parts by weight: 2.5 parts of Hedyotis diffusa, 2.5 parts of Hedyotis diffusa, 2.5 parts of Fritillaria thunbergii, 2.5 parts of Lobelia chinensis, 2 parts of Sinapis alba, 1.67 parts of Morus alba leaf, 1.67 parts of Perilla frutescens leaf, 1.67 parts of Citrus medica, 1.67 parts of Pogostemon cablin, 1.67 parts of Laminaria japonica, 1.67 parts of Prunus mume, 1.67 parts of Glycyrrhiza uralensis, 1.67 parts of Chrysanthemum morifolium, 1.33 parts of Lonicera japonica, and 1 part of Rosa rugosa.

[0008] This invention provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of a traditional Chinese medicine preparation for treating pulmonary nodules.

[0009] This invention provides a traditional Chinese medicine preparation for treating pulmonary nodules, comprising the above-mentioned traditional Chinese medicine composition.

[0010] Furthermore, traditional Chinese medicine preparations also include pharmaceutically acceptable excipients or carriers.

[0011] Furthermore, the traditional Chinese medicine preparation is for internal use.

[0012] Furthermore, the dosage forms of traditional Chinese medicine preparations include decoctions, syrups, mixtures, granules, tablets, or capsules.

[0013] The present invention has the following beneficial effects: (1) Traditional Chinese medicine believes that the pathogenesis of pulmonary nodules is mainly due to two aspects: firstly, the lungs are inherently weak and the body is congenitally deficient; secondly, the body is malnourished after birth. Both of these factors can lead to a decline in the lungs' ability to resist pathogens under the influence of various pathogenic factors. Heat, phlegm, blood stasis, cold coagulation, and lung toxins can invade the lung system, causing stagnation of the lung collaterals and accumulation, resulting in pulmonary nodules. The treatment principles of traditional Chinese medicine are clearing heat and detoxifying, softening and dispersing nodules, clearing heat and phlegm, soothing the liver and relieving depression, promoting lung function and regulating qi, and detoxifying and resolving nodules. The herbal composition of this invention can effectively improve the symptoms of dry cough, wheezing, shortness of breath and chest tightness in patients with pulmonary nodules. It has a stronger effect on shortness of breath, wheezing, coughing and expectoration when dissolving pulmonary nodules. At the same time, it takes into account the conditioning of the spleen, stomach and liver, which can avoid the gastrointestinal discomfort and heavy burden caused by oral medications, as well as the liver and kidney damage caused by drugs.

[0014] (2) The traditional Chinese medicine composition of the present invention uses Hedyotis diffusa and Hedyotis diffusa as the principal herbs; Hedyotis diffusa clears heat and detoxifies, promotes diuresis and eliminates carbuncles; Hedyotis diffusa clears heat and detoxifies, invigorates blood and qi, and relieves pain; the two herbs together have the functions of clearing heat and detoxifying, softening hardness and dissipating nodules. Lobelia chinensis, Fritillaria thunbergii, Sinapis alba, Laminaria japonica, Lonicera japonica, Chrysanthemum morifolium and Prunus mume are the assistant herbs; Lobelia chinensis clears heat and detoxifies, promotes diuresis and reduces swelling; Fritillaria thunbergii clears heat, resolves phlegm and stops cough, detoxifies and dissipates nodules and eliminates carbuncles; Sinapis alba warms and transforms cold phlegm, unblocks collaterals and relieves pain; Laminaria japonica resolves phlegm, softens hardness and dissipates nodules, promotes diuresis and reduces swelling; Lonicera japonica clears heat and detoxifies, disperses wind-heat; Chrysanthemum morifolium disperses wind and clears heat, calms the liver and improves eyesight, clears heat and detoxifies; Prunus mume astringes the lungs, astringes the intestines, generates fluids and expels roundworms; the combination of these herbs has the functions of clearing heat and phlegm, soothing the liver and relieving depression, promoting lung qi and regulating qi, detoxifying and dissipating nodules. The formula uses patchouli, perilla leaves, mulberry leaves, and bergamot as adjuvant herbs. Patchouli, in particular, is aromatic and dispels turbidity, harmonizes the stomach and stops vomiting, and releases exterior pathogens and relieves summer heat. Perilla leaves release exterior pathogens and dispel cold, regulate qi and harmonize the stomach. Mulberry leaves disperse wind-heat, clear the lungs and moisten dryness, and clear the liver and improve eyesight. Bergamot soothes the liver and regulates qi, harmonizes the stomach and relieves pain, and dries dampness and resolves phlegm. These herbs together act as adjuvant herbs, dispelling exterior pathogens, regulating qi and clearing heat, descending pathogenic factors, and softening and dissolving nodules. Licorice and rose are used as guiding herbs to harmonize the liver and lungs. The combined effects of these herbs directly target the affected area, working synergistically to soften and shrink the nodules until they disappear. Detailed Implementation

[0015] The principles and features of the present invention are described below with reference to embodiments. These embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Unless otherwise specified, specific conditions or manufacturer-recommended conditions should be followed in the embodiments. Reagents or instruments whose manufacturers are not specified are all commercially available products.

[0016] Example 1: A traditional Chinese medicine composition for treating pulmonary nodules comprises the following components in parts by weight: 2.0 parts of Hedyotis diffusa, 2.0 parts of Hedyotis diffusa, 2.0 parts of Fritillaria thunbergii, 2.0 parts of Lobelia chinensis, 1.5 parts of Sinapis alba, 1.5 parts of Morus alba leaf, 1.5 parts of Perilla frutescens leaf, 1.5 parts of Citrus medica, 1.5 parts of Pogostemon cablin, 1.5 parts of Laminaria japonica, 1.5 parts of Prunus mume, 1.5 parts of Glycyrrhiza uralensis, 1.5 parts of Chrysanthemum morifolium, 1.0 part of Lonicera japonica, and 0.8 parts of Rosa rugosa.

[0017] The above-mentioned traditional Chinese medicine composition is prepared into traditional Chinese medicine granules. The preparation method includes the following steps: (1) White flower snake tongue grass, rock hemp, Zhejiang fritillary bulb, half lobelia, mulberry leaf, perilla leaf, chrysanthemum, honeysuckle, rose and patchouli are cleaned, the stems are removed and dried. Kelp, dried plum and licorice are sieved to remove impurities and the pre-treated raw material 1 is obtained. (2) Crush the white mustard seeds and break the Buddha's hand to obtain pre-treated raw material 2; (3) Mix the pretreated raw materials 1 and 2 obtained in steps (1) and (2) evenly, and then package them to obtain Chinese medicine packs; (4) Put the Chinese herbal medicine package obtained in step (3) into a stainless steel extraction tank, add water at a weight ratio of Chinese herbal medicine to water of 1:10 and soak for 1 hour, then heat to 100°C, boil and maintain the temperature for 1 hour, and collect the extract. After the first extraction, add water at a weight ratio of Chinese herbal medicine to water of 1:8 and soak again for half an hour, then heat to 100°C, boil and maintain the temperature for 1 hour, and combine to obtain the extract; (5) After passing the extract obtained in step (4) through a 300-mesh or high-speed separation device, concentrate it in a concentrator at a temperature of 75°C and a vacuum of -0.04MPa to obtain a concentrated solution; (6) The concentrate obtained in step (5) is concentrated at 65°C and -0.06MPa vacuum, and the relative density is controlled at 1.10-1.20 to obtain a traditional Chinese medicine extract; (7) The Chinese herbal extract from step (6) is processed into Chinese herbal granules by passing it through a one-step granulator (spraying speed: 150-200mL / min, air inlet temperature: 65-85℃); (8) After measuring the moisture, particle size and content of marker components of the Chinese medicine granules obtained in step (7), they are put into a granule packaging machine and packaged into 10g / bags to obtain Chinese medicine compound granules, thus obtaining Chinese medicine granules for the treatment of pulmonary nodules.

[0018] Example 2: A traditional Chinese medicine composition for treating pulmonary nodules comprises the following components in parts by weight: 3.0 parts of Hedyotis diffusa, 3.0 parts of Hedyotis diffusa, 3.0 parts of Fritillaria thunbergii, 3.0 parts of Lobelia chinensis, 2.5 parts of Sinapis alba, 2.0 parts of Morus alba leaf, 2.0 parts of Perilla frutescens leaf, 2.0 parts of Citrus medica, 2.0 parts of Pogostemon cablin, 2.0 parts of Laminaria japonica, 2.0 parts of Prunus mume, 2.0 parts of Glycyrrhiza uralensis, 2.0 parts of Chrysanthemum morifolium, 1.5 parts of Lonicera japonica, and 1.2 parts of Rosa rugosa.

[0019] The above-mentioned traditional Chinese medicine composition was prepared into traditional Chinese medicine granules, and the preparation method was the same as in Example 1.

[0020] Example 3: A traditional Chinese medicine composition for treating pulmonary nodules comprises the following components in parts by weight: A traditional Chinese medicine composition for dissolving pulmonary nodules comprises the following raw materials in parts by weight: 2.5 parts of Hedyotis diffusa, 2.5 parts of Hedyotis diffusa, 2.5 parts of Fritillaria thunbergii, 2.5 parts of Lobelia chinensis, 2 parts of Sinapis alba, 1.67 parts of Morus alba leaf, 1.67 parts of Perilla frutescens leaf, 1.67 parts of Citrus medica, 1.67 parts of Pogostemon cablin, 1.67 parts of Laminaria japonica, 1.67 parts of Prunus mume, 1.67 parts of Glycyrrhiza uralensis, 1.67 parts of Chrysanthemum morifolium, 1.33 parts of Lonicera japonica, and 1 part of Rosa rugosa.

[0021] The above-mentioned traditional Chinese medicine composition was prepared into traditional Chinese medicine granules, and the preparation method was the same as in Example 1.

[0022] Comparative Example 1: The only difference between Comparative Example 1 and Example 3 is that the principal ingredient is only Hedyotis diffusa. The traditional Chinese medicine composition of Comparative Example 1 was prepared into traditional Chinese medicine granules, and the preparation method was the same as that of Example 1.

[0023] Comparative Example 2: The only difference between Comparative Example 2 and Example 3 is that the principal ingredient is only *Hemiberlesia lingua*. The herbal composition of Comparative Example 2 was prepared into herbal granules using the same method as in Example 1.

[0024] Comparative Example 3: The only difference between Comparative Example 3 and Example 3 is that *Scutellaria baicalensis* was replaced with *Ophiopogon japonicus*. The herbal composition of Comparative Example 3 was prepared into herbal granules using the same method as in Example 1.

[0025] Comparative Example 4: The only difference between Comparative Example 4 and Example 3 is that Lobelia chinensis was replaced with dandelion and white mustard seed was replaced with Lepidium apetalum. The traditional Chinese medicine composition of Comparative Example 4 was prepared into traditional Chinese medicine granules, and the preparation method was the same as in Example 1.

[0026] Comparative Example 5: The only difference between Comparative Example 5 and Example 3 is that Fritillaria thunbergii was replaced with oyster shell and Laminaria japonica was replaced with Prunella vulgaris. The traditional Chinese medicine composition of Comparative Example 5 was prepared into traditional Chinese medicine granules, and the preparation method was the same as in Example 1.

[0027] Trial example: Clinical trial The traditional Chinese medicine compositions of Example 3 and Comparative Examples 1-5 were subjected to a randomized controlled clinical trial, and the specific methods are as follows: (1) Case selection: The Chinese expert consensus on the diagnosis and treatment of pulmonary nodules (2018 edition) and the Chinese guidelines for the classification, diagnosis and treatment of pulmonary nodules (2016 edition) drafted by the Chinese Expert Group on Early Diagnosis and Treatment of Lung Cancer in 2016 were referenced. (2) Selected cases: 180 patients with pulmonary nodules who came to the hospital were randomly divided into 6 groups, with 30 people in each group.

[0028] (3) Exclusion criteria: having underlying diseases that are relatively serious, having many or serious concurrent symptoms, requiring adjustments to the prescription based on the symptoms during treatment, or having symptoms that do not match the prescription.

[0029] (4) Treatment method: 30 patients in each group of Example 3 and Comparative Examples 1-5 were given two bags of the prepared Chinese medicine formula composition three times a day for 90 days.

[0030] (5) Efficacy criteria: Observe the morphology of nodules on CT after treatment. If the nodules shrink significantly or disappear in patients treated with this formula, it is determined to be effective; if the condition is stable and the nodules shrink by less than 2 mm or the nodules do not change but the symptoms are relieved, it is determined to be effective; if the nodules increase slightly but are still within a controllable range, it is determined to be ineffective.

[0031] (6) Treatment results: The treatment status of patients with pulmonary nodules was statistically analyzed 3 months later. The statistical results are shown in Table 1 and Table 2.

[0032] Table 1 Statistical Results of Treatment

[0033] Table 2 Statistical results of nodule changes after treatment

[0034] (7) Adverse reactions: No obvious side effects or adverse reactions were found in the patients during the treatment.

[0035] (8) Clinical Conclusions: The clinical data in Tables 1-2 show that the efficacy of the traditional Chinese medicine composition provided by the present invention in Example 3 reached 90%, which is much higher than that of Comparative Examples 1-5. Among them, the removal of *Hedyotis diffusa* from Comparative Example 1 reduced the efficacy of this formula in softening and dispersing nodules; the removal of *Hedyotis diffusa* from the principal herb in Comparative Example 2 reduced the efficacy of this formula in clearing heat and detoxifying; and the replacement of *Hedyotis diffusa* with *Ophiopogon japonicus* in Comparative Example 3, since *Ophiopogon japonicus* mainly has the effect of nourishing yin and moistening the lungs, the absence of *Hedyotis diffusa* would reduce the effect of this formula in promoting blood circulation and breaking up nodules. Therefore, changing the principal herb would significantly reduce the clinical efficacy for treating nodules. Replacing *Lobelia chinensis* and *Sinapis alba* from the assistant herbs with *Taraxacum mongolicum* and *Lepidium apetalum*, *Lobelia chinensis* can simultaneously disperse blood stasis, promote diuresis, and eliminate local swelling and nodules, making it suitable for nodules caused by phlegm and dampness stagnation; *Taraxacum mongolicum* focuses on clearing heat and reducing inflammation, but lacks the effect of resolving blood stasis and unblocking collaterals, and cannot clear stagnant nodules in the lungs. White mustard seed excels at penetrating meridians and dissolving deep-seated phlegm nodules and lumps; Lepidium seed can only drain superficial phlegm and cannot dissolve solidified phlegm, resulting in a poorer effect on shrinking substantial nodules in clinical treatment. In the auxiliary herbs, Fritillaria thunbergii and Laminaria japonica are replaced with Ostrea gigas and Prunella vulgaris. Fritillaria thunbergii specializes in clearing the lungs, resolving phlegm, relieving stagnation, and dispersing nodules, effectively breaking down phlegm-laden lumps in the lungs; Ostrea gigas only has astringent and softening properties, with weak phlegm-resolving and penetrating abilities, unable to dissolve phlegm nodules layer by layer. Laminaria japonica promotes diuresis, eliminates phlegm, and penetrates deep nodules, with strong penetrating power for hidden nodules in the lungs; Prunella vulgaris focuses on superficial goiter lumps, with insufficient effect on dispersing nodules deep in the lungs, resulting in a poorer effect on deep nodules. Therefore, changing the auxiliary herbs reduces the clinical efficacy of this formula. This demonstrates that the components of this invention have a synergistic effect, and changing, subtracting, or replacing any component of the herbal composition will lead to a decrease in its therapeutic effect.

[0036] Typical Case: Case 1: Ms. Ji, female, 61 years old, first visited our hospital in December 2023. Chief complaint: The patient suffered from a severe cold accompanied by general weakness, and a physical examination revealed pulmonary nodules. She also experienced shortness of breath, chest tightness, and occasional cough. Present illness: Chest CT scan showed multiple nodules in the left lung, right upper lobe, and right lower lobe, with the largest located in the lateral basal segment of the left lower lobe (long diameter approximately 8mm). Western medicine diagnosis: Pulmonary nodules, upper respiratory tract infection. Traditional Chinese medicine diagnosis: Lung heat toxin accumulation, pulmonary mass. She took the Chinese herbal composition of Example 3 for 3 months. At her follow-up visit in May 2024, her chief complaint was that her cough had improved and she was still weak. Her symptoms had significantly improved, and a repeat chest CT scan showed scattered solid micronodules in both lungs, less than 5mm in diameter, which had significantly shrunk compared to the previous scan.

[0037] Case 2: Mr. Zhu, male, 73 years old, first visited our hospital in December 2023. Chief complaint: Cough, shortness of breath, foreign body sensation in the throat, and lower back and leg pain in recent years; pale, swollen, and dark-colored tongue with a white coating. Present illness: Chest CT scan showed small nodules in both lungs, the largest being located in the lower lobe of the left lung (long diameter approximately 6mm). Western medicine diagnosis: pulmonary nodule, chronic pharyngitis. Traditional Chinese medicine diagnosis: pulmonary tumor, heat toxin accumulation. He took the Chinese herbal composition of Example 3 for 3 months. At his follow-up visit in March 2024, his chief complaint was that his cough had improved and he still had lower back pain. A follow-up CT scan in March 2024 showed multiple punctate shadows and multiple calcifications in both lungs, and the nodules had disappeared.

[0038] Case 3: Ms. Cheng, female, 47 years old, first visited our hospital in September 2022. Chief complaint: The patient experienced excessive sweating, hot flashes, and poor sleep. Present illness: The patient's chest CT report showed increased lung markings in both lungs, nodular calcification in the upper lobe of the right lung, and a 5mm diameter ground-glass nodule in the lower lobe of the right lung. Western medicine diagnosis: Pulmonary nodules. Traditional Chinese medicine diagnosis: Lung mass, Yin deficiency with excessive fire. The patient took the herbal composition of Example 3 for 3 months. A follow-up CT scan in May 2023 showed multiple scattered patchy, linear, and nodular areas of increased density in the upper lobe of the left lung, with some lesions calcified. The bronchi were patent. The nodules had disappeared.

[0039] Case 4: Mr. Fan, male, 40 years old, first visited our hospital in October 2021. Chief complaint: Pulmonary sarcoidosis, cough with excessive sputum and discomfort. Present illness: Chest CT report showed a pure ground-glass nodule in the posterior segment of the left lower lobe, measuring approximately 12.1 mm × 6.9 mm. Several solid and ground-glass nodules were seen in the right lung, the largest being located in the right lower lobe, with a diameter of approximately 3 mm. Western medicine diagnosis: Pulmonary nodule, upper respiratory tract infection. Traditional Chinese medicine diagnosis: Pulmonary mass, phlegm and blood stasis obstruction. He took the Chinese medicine composition of Example 3 for 3 months. At the follow-up visit in April 2022, a chest CT scan showed multiple small solid nodules in the right lung, all less than 5 mm in diameter, significantly smaller than before.

[0040] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating pulmonary nodules, characterized in that, The product comprises the following components in parts by weight: 1.0-10.0 parts of Hedyotis diffusa, 1.0-10.0 parts of Hedyotis diffusa, 1.0-10.0 parts of Fritillaria thunbergii, 1.0-10.0 parts of Lobelia chinensis, 1.0-8.0 parts of Sinapis alba, 1.0-8.0 parts of Morus alba leaf, 1.0-8.0 parts of Perilla frutescens leaf, 1.0-8.0 parts of Citrus medica, 1.0-8.0 parts of Pogostemon cablin, 1.0-8.0 parts of Laminaria japonica, 1.0-8.0 parts of Prunus mume, 1.0-8.0 parts of Glycyrrhiza uralensis, 1.0-8.0 parts of Chrysanthemum morifolium, 0.5-6.0 parts of Lonicera japonica, and 0.5-6.0 parts of Rosa rugosa.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The formula comprises the following components in parts by weight: 2.0-3.0 parts of Hedyotis diffusa, 2.0-3.0 parts of Hedyotis diffusa, 2.0-3.0 parts of Fritillaria thunbergii, 2.0-3.0 parts of Lobelia chinensis, 1.5-2.5 parts of Sinapis alba, 1.5-2.0 parts of Morus alba leaf, 1.5-2.0 parts of Perilla frutescens leaf, 1.5-2.0 parts of Citrus medica, 1.5-2.0 parts of Pogostemon cablin, 1.5-2.0 parts of Laminaria japonica, 1.5-2.0 parts of Prunus mume, 1.5-2.0 parts of Glycyrrhiza uralensis, 1.5-2.0 parts of Chrysanthemum morifolium, 1.0-1.5 parts of Lonicera japonica, and 0.8-1.2 parts of Rosa rugosa.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The ingredients include the following components by weight: 2.5 parts Oldenlandia diffusa, 2.5 parts Hedyotis diffusa, 2.5 parts Fritillaria thunbergii, 2.5 parts Lobelia chinensis, 2 parts Sinapis alba, 1.67 parts Morus alba leaf, 1.67 parts Perilla frutescens leaf, 1.67 parts Citrus medica, 1.67 parts Patchouli, 1.67 parts Laminaria japonica, 1.67 parts Prunus mume, 1.67 parts Glycyrrhiza uralensis, 1.67 parts Chrysanthemum morifolium, 1.33 parts Lonicera japonica, and 1 part Rosa rugosa.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a traditional Chinese medicine preparation for treating pulmonary nodules.

5. A traditional Chinese medicine preparation for treating pulmonary nodules, characterized in that, Includes the traditional Chinese medicine composition according to any one of claims 1-3.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, It also includes pharmaceutically acceptable excipients or carriers.

7. The traditional Chinese medicine preparation according to claim 5 or 6, characterized in that, The traditional Chinese medicine preparation is for internal use.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, syrups, mixtures, granules, tablets, or capsules.

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