A traditional Chinese medicine composition for pulmonary nodule and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine composition for pulmonary nodules and its preparation method. The composition is prepared from the following components in parts by weight: 6-30 parts raw oyster shell, 3-15 parts Scrophularia ningpoensis, 3-15 parts Fritillaria thunbergii, 2-10 parts Uncaria rhynchophylla, 3-15 parts vinegar-processed turtle shell, 3-15 parts stir-fried Bombyx mori, 2-10 parts stir-fried mustard seed, 2-10 parts processed Pinellia ternata, 3-15 parts Codonopsis pilosula, 2-10 parts vinegar-processed Curcuma zedoaria, 3-15 parts Rhodiola rosea, 2-10 parts bee honeycomb, 6-30 parts lily bulb, 3-15 parts dried plum, 3-15 parts Ganoderma lucidum, 2-10 parts stir-fried bitter almond, 3-15 parts honey-processed mulberry bark, and 2-10 parts Scutellaria baicalensis. This invention has the functions of resolving phlegm and removing blood stasis, attacking toxins and dispersing nodules, invigorating qi and promoting qi circulation, and nourishing yin and moistening the lungs. It is used in medicines and health products for pulmonary nodules.

Description

Technical Field

[0002] This invention relates to the field of traditional Chinese medicine for pulmonary nodules, and more specifically to a traditional Chinese medicine composition for pulmonary nodules and its preparation method. Background Technology

[0004] In the medical field, pulmonary nodules are a health topic of great concern. With the continuous advancement of medical imaging technology, the detection rate of pulmonary nodules has gradually increased, drawing widespread attention to this disease.

[0005] According to the latest data released by the National Cancer Center in 2024, lung cancer ranks first in both incidence and mortality among malignant tumors in my country, with a crude incidence rate of 75.13 / 100,000 and a crude mortality rate of 51.94 / 100,000. Early-stage lung cancer or precancerous lesions mainly appear as pulmonary nodules on imaging, making pulmonary nodules a crucial window for early diagnosis and treatment of lung cancer. Pulmonary nodules are defined on imaging as focal, round or oval, solid or subsolid pulmonary shadows with increased density, ≤3 cm in diameter. They can be solitary or multiple, without atelectasis, hilar lymphadenopathy, or pleural effusion. The detection rate of pulmonary nodules in individuals undergoing chest CT scans ranges from 20% to 50%.

[0006] To this end, national and international industry standards have formulated a series of diagnostic criteria for pulmonary nodules, such as the "Guidelines for Classification, Diagnosis and Treatment of Pulmonary Nodules in China (2016 Edition)," the 2017 Fleischner Society Guidelines for the Management of Pulmonary Nodules, the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)," the 2023 "Expert Consensus on the Integrated Traditional Chinese and Western Medicine Management of Pulmonary Nodules," and the "Expert Consensus on the Diagnosis and Management of Pulmonary Nodules Based on Screening of High-Risk Groups for Lung Cancer," etc., which are standardized guidelines for the diagnosis and treatment of pulmonary nodules using both traditional Chinese and Western medicine. The criteria are limited to pulmonary nodules with a diameter ≤3cm, regardless of the location, number (single or multiple), shape (irregular or round), density (solid, non-solid / pure ground-glass opacity, partially solid / mixed ground-glass opacity), or the duration of the disease from nodule discovery to consultation. There are no restrictions on the patient's race, ethnicity, age, or the TCM syndrome at the time of consultation.

[0007] In recent years, the incidence of pulmonary nodules has been on the rise due to factors such as environmental pollution and smoking habits. According to the latest medical research reports, the incidence of pulmonary nodules is increasing globally, especially in large countries with large populations like China. Data from the Chinese Center for Disease Control and Prevention shows that the incidence of pulmonary nodules in China is approximately 10%, reflecting to some extent the challenges facing public health in the country. In large cities like Shanghai, the incidence may be even higher due to factors such as environmental pollution, life stress, and an aging population. One study indicated that the incidence of pulmonary nodules among Shanghai residents may exceed the national average, reaching 12.5%. Furthermore, patients with lung infections following the spread of COVID-19 in 2022 all developed residual pulmonary nodules to varying degrees.

[0008] The danger of lung nodules depends primarily on their nature. Benign lung nodules usually do not cause serious symptoms, but malignant lung nodules can develop into lung cancer, endangering life. Therefore, timely detection and diagnosis of lung nodules are crucial. Malignant lung nodules are a health threat that cannot be ignored. According to multiple medical studies, malignant lung nodules may lead to lung cancer. Early stages may be asymptomatic, but as the disease progresses, they can invade surrounding tissues and even metastasize to distant sites, posing a serious threat to life.

[0009] The causes of pulmonary nodules are complex and diverse, mainly including infection, inflammation, autoimmune diseases, and lung cancer. Infections such as pneumonia and tuberculosis are common causes of pulmonary nodules; while factors such as smoking and environmental pollution may increase the risk of lung cancer, thus leading to malignant pulmonary nodules. Pulmonary nodules may originate from inflammation, infection such as tuberculosis and fungal infections, or benign lung tumors such as hamartomas. However, the most concerning aspect is their relationship with lung cancer, with 15%–20% of pulmonary nodules eventually being diagnosed as malignant. Smoking, environmental exposure, such as long-term asbestos exposure, and genetic factors may all increase the risk of developing malignant pulmonary nodules. In addition, immune system diseases, such as Wegener's granulomatosis, may also lead to the development of pulmonary nodules. Early detection and diagnosis are crucial because the five-year survival rate for early-stage lung cancer is much higher than that for late-stage lung cancer.

[0010] Pulmonary nodules are an imaging diagnosis, and there is no corresponding disease name in ancient Chinese medicine texts. Based on their space-occupying nature, they can be categorized under the TCM concepts of lung accumulation and mass. If accompanied by clinical symptoms, they can be classified under the lung-related diseases such as cough and wheezing. According to literature reports, pulmonary nodules are generally a disease of deficiency of vital energy and excess of pathogenic factors. They may be caused by emotional distress, improper diet, overwork or lack of rest, or congenital deficiencies leading to lung qi deficiency, coupled with external pathogenic factors such as smoke, smog, six pathogenic factors, and ionizing radiation, resulting in poor circulation of qi and blood, phlegm and blood stasis accumulating in the lung collaterals, eventually forming nodules. Dampness, phlegm, blood stasis, and toxins are considered key pathological factors in the development of pulmonary nodules, while tonifying qi, resolving phlegm, dispersing nodules, and unblocking collaterals are considered important treatment principles for pulmonary nodules. Internal treatment methods are based on the principle of syndrome differentiation and treatment. For example, Zhang Xichun, a physician of the Qing Dynasty, proposed a method of clearing heat, resolving phlegm, detoxifying, and dispersing nodules in his book *Medical Records of Integrating Chinese and Western Medicine*. This method often uses herbs such as Scutellaria baicalensis, Platycodon grandiflorus, and Fritillaria thunbergii to address lung heat and phlegm stasis. Modern research has also confirmed that these herbs have anti-inflammatory, antioxidant, and immunomodulatory effects. Clinical data shows that traditional Chinese medicine treatment for pulmonary nodules can alleviate symptoms, shrink nodules to some extent, and improve patients' quality of life; however, there are currently no drugs on the market that can completely eliminate nodules.

[0011] Currently, surgical treatment is the primary approach, but it has significant limitations. While a single, isolated nodule can be treated with minimally invasive surgery, multiple nodules may require partial or even complete lobectomy. Furthermore, many patients experience prolonged wound healing periods post-surgery, and the side effects of peripheral neuralgia are particularly difficult to endure. Therefore, researching innovative drugs to address nodule issues is crucial and readily accepted by patients, given the large number of nodule sufferers. Effective drug treatment not only ensures timely care but also reduces the incidence of lung cancer. In the long run, this can effectively lower national medical insurance costs and alleviate the burden on the national healthcare system.

[0012] Therefore, as of now, there are no effective drugs for pulmonary nodules that have been researched and marketed, making this invention significant and innovative. Summary of the Invention

[0014] The purpose of this invention is to provide a traditional Chinese medicine composition and preparation method for treating pulmonary nodules.

[0015] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition is prepared from the following components in parts by weight: 6-30 parts raw oyster shell, 3-15 parts scrophularia root, 3-15 parts Fritillaria thunbergii, 2-10 parts Uncaria rhynchophylla, 3-15 parts vinegar-processed turtle shell, 3-15 parts stir-fried silkworm pupae, 2-10 parts stir-fried mustard seed, 2-10 parts processed Pinellia ternata, 3-15 parts Codonopsis pilosula, 2-10 parts vinegar-processed Curcuma zedoaria, 3-15 parts Rhodiola rosea, 2-10 parts bee honeycomb, 6-30 parts lily bulb, 3-15 parts dried plum, 3-15 parts Ganoderma lucidum, 2-10 parts stir-fried bitter almond, 3-15 parts honey-processed mulberry bark, and 2-10 parts Scutellaria baicalensis.

[0016] This traditional Chinese medicine composition is based on many years of clinical experience. From TCM theory to formulation, the first step is to summarize TCM theory based on the etiology and pathogenesis of common patients in clinical practice, design the functions and indications according to TCM theory, and then proceed to the formulation. After the formulation is composed, it is repeatedly refined in clinical practice, and finally the optimal formulation and proportions are determined.

[0017] According to embodiments of the present invention, the present invention can be further optimized, and the optimized technical solution is as follows: In one preferred embodiment, the traditional Chinese medicine composition further includes the following medicinal materials in parts by weight: 0.001 to 5 parts of toad venom.

[0018] The beneficial technical effects of the traditional Chinese medicine composition of this invention are as follows: Traditional Chinese medicine (TCM) possesses advantages in syndrome differentiation and treatment, holistic regulation, and comprehensive management, enabling it to participate in the construction and improvement of the nodule diagnosis and treatment system in a full-cycle and multi-dimensional manner. TCM plays a certain role in shrinking nodules, alleviating symptoms, improving patients' physical condition, reducing the probability of nodule malignancy, and improving the microenvironment of pulmonary nodules.

[0019] The root cause of pulmonary nodules is the deficiency of both Qi and Yin, leading to impaired lung function. Zhang Gao's *Medical Discourses* states that "the lung is a delicate organ, sensitive to cold and averse to heat, thus easily damaged by pathogenic factors and difficult to treat." Traditional Chinese medicine classifies pulmonary nodules under the category of "accumulation syndromes," specifically one of the five types of accumulations, specifically an accumulation in the lungs, known as "pulmonary accumulation." The main evolutionary process of pulmonary nodules involves Qi stagnation, phlegm and blood stasis accumulation, and over time, toxicity, and is related to the lungs, heart, liver, and spleen. The core pathogenesis of pulmonary nodules is the deficiency of both Qi and Yin, with the manifestation of phlegm and blood stasis. Therefore, the treatment principle is to dispel blood stasis and nodules, and to nourish Qi and Yin. Treatment focuses on resolving phlegm, dispelling blood stasis and nodules, and nourishing Qi and Yin to moisten the lungs, employing a combined approach of addressing the symptoms and strengthening the root cause.

[0020] Raw oyster has the functions of nourishing yin and suppressing yang, softening hardness and resolving phlegm; Scrophularia has the functions of nourishing yin and cooling blood, detoxifying and dispersing nodules; Fritillaria thunbergii has the functions of clearing heat and resolving phlegm, dispersing nodules and reducing swelling; Uncaria rhynchophylla has the functions of clearing heat and detoxifying, resolving phlegm and dispersing nodules; Vinegar-processed turtle shell has the functions of nourishing yin and suppressing yang, softening hardness and dispersing nodules; and stir-fried Bombyx mori has the functions of resolving phlegm and dispersing nodules. These six herbs work together to nourish yin, soften hardness, resolve phlegm and disperse nodules, directly targeting pulmonary nodules as the principal herbs; stir-fried mustard seed has the functions of warming the middle and dispelling cold, promoting qi and resolving phlegm; processed Pinellia ternata has the function of resolving phlegm; Codonopsis pilosula has the functions of tonifying the middle and replenishing qi, resolving phlegm and relieving cough; and vinegar-processed Curcuma zedoaria has the functions of promoting qi and breaking blood stasis, eliminating accumulation and relieving pain. The functions of Rhodiola rosea are to replenish qi, clear the lungs, disperse blood stasis, and reduce swelling. Beehive has the functions of attacking toxins and relieving pain. The six herbs work together to resolve phlegm, replenish qi, promote qi circulation, disperse blood stasis, attack toxins, and relieve pain, assisting the principal herbs and serving as assistant herbs. Lily bulb has the functions of nourishing yin and moistening the lungs. Mume has the functions of astringing the lungs and generating fluids. Ganoderma lucidum has the functions of replenishing qi, stopping coughs, and relieving asthma. Fried bitter almond has the functions of lowering qi, stopping coughs, and relieving asthma. Honey mulberry bark has the functions of purging the lungs, relieving asthma, promoting diuresis, and reducing swelling. Scutellaria baicalensis has the functions of clearing heat and purging fire. The six herbs work together to nourish yin and moisten the lungs, clear heat and purge the lungs, stop coughs, and relieve asthma, assisting the principal herbs and serving as adjuvant herbs.

[0021] The above-mentioned principal, assistant, adjuvant, and guiding herbs work together to resolve phlegm and remove blood stasis, attack toxins and dissipate nodules, invigorate qi and promote qi circulation, and nourish yin and moisten the lungs. The treatment of pulmonary nodules adopts the principle of treating both the symptoms and the root cause, with the primary focus on addressing the symptoms and the secondary focus on strengthening the root cause.

[0022] The traditional Chinese medicine composition described in this invention has controllable quality, is convenient and safe to use, and is suitable for industrial production.

[0023] The raw materials of the traditional Chinese medicine composition of this invention are mainly natural medicinal materials, and the main active ingredients are isolated; it treats both the symptoms and the root cause, and addresses both internal and external issues. It is mild, safe and effective, and fills a gap in clinical drug use.

[0024] The traditional Chinese medicine composition for pulmonary nodules of the present invention extracts the active ingredients of medicinal materials through conventional and / or unconventional extraction methods, and prepares them into appropriate formulations. These formulations possess the functions of resolving phlegm and removing blood stasis, attacking toxins and dispersing nodules, invigorating qi and promoting qi circulation, and nourishing yin and moistening the lungs, and are used for pulmonary nodules. Long-term use is safe and effective, fully meeting green requirements. Therefore, this traditional Chinese medicine composition also has significant innovativeness and social benefits from industrialization.

[0025] This invention provides a safe and effective traditional Chinese medicine composition for pulmonary nodules, which uses natural medicinal materials as the main raw materials, is easily accepted by patients with nodules, has definite curative effect, controllable quality, and is suitable for industrial production. Detailed Implementation

[0027] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0028] Example

[0029] Prescription: Raw oyster shell 6 parts, Scrophularia ningpoensis 3 parts, Fritillaria thunbergii 3 parts, Uncaria rhynchophylla 2 parts, Vinegar-processed turtle shell 3 parts, stir-fried silkworm 3 parts, stir-fried mustard seed 2 parts, processed Pinellia ternata 2 parts, Codonopsis pilosula 3 parts, Vinegar-processed Curcuma zedoaria 2 parts, Rhodiola rosea 3 parts, Vespa nidus 2 parts, Lilium brownii 6 parts, Prunus mume 3 parts, Ganoderma lucidum 3 parts, stir-fried bitter almond 2 parts, honey-processed mulberry bark 3 parts, Scutellaria baicalensis 2 parts.

[0030] Step 1: Take vinegar-processed Curcuma zedoaria, add 6 times the amount of water, and extract the volatile oil by steam distillation. Pack the volatile oil into powder and set aside. Separately collect the aqueous solution and set aside the residue.

[0031] Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds. Use 6 times 70% ethanol to reflux and extract twice, 1.5 hours each time. Filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.13 (50℃). Set aside for later use. Set aside the dregs for later use.

[0032] Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria root to the dregs from step 3 and step 2. Decoct twice with water (8 and 6 times the amount), 1.5 hours each time. Filter the decoction in batches and combine the filtrates.

[0033] Step 4: Take the volatile oil and extract from Steps 1 to 3, concentrate under reduced pressure to a thick paste with a relative density of 1.30 to 1.35 (50°C), vacuum dry, pulverize, add micronized silica gel, dextrin and the above volatile oil inclusions, mix well, form into granules, and fill into capsules or tablets to obtain the final product. Example

[0034] Prescription: 15 parts raw oyster shell, 8 parts scrophularia, 8 parts fritillaria thunbergii, 5 parts cat's claw herb, 8 parts vinegar-processed turtle shell, 8 parts stir-fried silkworm, 5 parts stir-fried mustard seed, 5 parts processed pinellia, 8 parts codonopsis, 5 parts vinegar-processed turmeric, 8 parts rhodiola rosea, 5 parts bee honeycomb, 15 parts lily bulb, 7 parts dried plum, 7 parts ganoderma lucidum, 5 parts stir-fried bitter almond, 8 parts honey-processed mulberry bark, 5 parts scutellaria baicalensis.

[0035] Step 1: Take vinegar-processed Curcuma zedoaria, add 7 times the amount of water, and extract the volatile oil by steam distillation. Pack the volatile oil into powder and set aside. Separately collect the aqueous solution and set aside the residue.

[0036] Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds. Use 8 times 75% ethanol to reflux and extract twice, 1 hour each time. Filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.15 (50℃). Set aside for later use. Set aside the dregs for later use.

[0037] Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria baicalensis to the dregs from step 3 and step 2. Decoct twice with water (7 and 5 times the amount), 2 hours each time. Filter the decoction in batches and combine the filtrates.

[0038] Step 4: Take the volatile oil and extract from Steps 1 to 3, concentrate under reduced pressure to a thick paste with a relative density of 1.30 to 1.35 (50°C), vacuum dry, pulverize, add micronized silica gel, dextrin and the above volatile oil inclusions, mix well, form into granules, and fill into capsules or tablets to obtain the final product. Example

[0039] Prescription: 30 parts raw oyster shell, 15 parts scrophularia, 15 parts Zhejiang fritillary bulb, 10 parts cat's claw herb, 15 parts vinegar-processed turtle shell, 15 parts stir-fried silkworm pupae, 10 parts stir-fried mustard seed, 10 parts processed pinellia, 15 parts codonopsis, 10 parts vinegar-processed turmeric, 15 parts rhodiola, 10 parts bee honeycomb, 30 parts lily bulb, 15 parts dried plum, 15 parts Ganoderma lucidum, 10 parts stir-fried bitter almond, 15 parts honey-processed mulberry bark, 10 parts scutellaria.

[0040] Step 1: Take vinegar-processed Curcuma zedoaria, add 10 times the amount of water, and extract the volatile oil by steam distillation. Collect the volatile oil for later use, and separately collect the aqueous solution for later use. Keep the residue for later use.

[0041] Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds. Use 10 times 80% ethanol to reflux and extract twice, 1 hour each time. Filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.2 (50℃). Set aside for later use. Set aside the dregs for later use.

[0042] Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria root to the dregs from step 3 and step 2. Decoct twice with water (10 and 8 times the amount), 1.5 hours each time. Filter the decoction in batches and combine the filtrates.

[0043] Step 4: Take the volatile oil and extract from Steps 1 to 3, add an appropriate amount of excipients, and mix thoroughly to obtain the oral liquid or granule formulation of the traditional Chinese medicine composition of the present invention. Example

[0044] Prescription: Raw oyster shell 6 parts, Scrophularia ningpoensis 3 parts, Fritillaria thunbergii 3 parts, Uncaria rhynchophylla 2 parts, Vinegar-processed turtle shell 3 parts, Fried silkworm 3 parts, Fried mustard seed 2 parts, Prepared Pinellia ternata 2 parts, Codonopsis pilosula 3 parts, Vinegar-processed Curcuma zedoaria 2 parts, Rhodiola rosea 3 parts, Bee honeycomb 2 parts, Lilium brownii 6 parts, Prunus mume 3 parts, Ganoderma lucidum 3 parts, Fried bitter almond 2 parts, Honey-processed mulberry bark 3 parts, Scutellaria baicalensis 2 parts, Toad venom 0.001 parts.

[0045] Step 1: Take vinegar-processed Curcuma zedoaria, add 6 times the amount of water, and extract the volatile oil by steam distillation. Pack the volatile oil into powder and set aside. Separately collect the aqueous solution and set aside the residue.

[0046] Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds. Use 6 times 70% ethanol to reflux and extract twice, 1.5 hours each time. Filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.13 (50℃). Set aside for later use. Set aside the dregs for later use.

[0047] Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria root to the dregs from step 3 and step 2. Decoct twice with water (8 and 6 times the amount), 1.5 hours each time. Filter the decoction in batches and combine the filtrates.

[0048] Step 4: Take toad venom, crush it, and soak it thoroughly in 5 times weak acid water / purified water at room temperature. Wash and filter it 3 times. Take the residue and extract it twice by reflux with 10 times 80% ethanol for 2 hours each time. Filter it, recover the ethanol from the filtrate, and keep the extract for later use.

[0049] Step 5: Take the volatile oil and extract from Steps 1 to 4, concentrate under reduced pressure to a thick paste with a relative density of 1.30 to 1.35 (50°C), vacuum dry, pulverize, add micronized silica gel, dextrin and the above volatile oil inclusions, mix well, form into granules, and fill into capsules or tablets to obtain the final product. Example

[0050] Prescription: 15 parts raw oyster shell, 8 parts scrophularia root, 8 parts Zhejiang fritillary bulb, 5 parts cat's claw herb, 8 parts vinegar-processed turtle shell, 8 parts stir-fried silkworm pupae, 5 parts stir-fried mustard seed, 5 parts processed pinellia tuber, 8 parts codonopsis root, 5 parts vinegar-processed turmeric, 8 parts rhodiola rosea, 5 parts bee honeycomb, 15 parts lily bulb, 7 parts dried plum, 7 parts Ganoderma lucidum, 5 parts stir-fried bitter almond, 8 parts honey-processed mulberry bark, 5 parts scutellaria root, 2 parts toad venom.

[0051] Step 1: Take vinegar-processed Curcuma zedoaria, add 7 times the amount of water, and extract the volatile oil by steam distillation. Pack the volatile oil into powder and set aside. Separately collect the aqueous solution and set aside the residue.

[0052] Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds. Use 8 times 75% ethanol to reflux and extract twice, 1 hour each time. Filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.15 (50℃). Set aside for later use. Set aside the dregs for later use.

[0053] Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria baicalensis to the dregs from step 3 and step 2. Decoct twice with water (7 and 5 times the amount), 2 hours each time. Filter the decoction in batches and combine the filtrates.

[0054] Step 4: Take toad venom, crush it, and soak it thoroughly in 6 times weak acid water / purified water at room temperature. Wash and filter it 4 times. Take the residue and extract it twice by reflux with 8 times 90% ethanol for 1.5 hours each time. Filter it, recover the ethanol from the filtrate, and keep the extract for later use.

[0055] Step 5: Take the volatile oil and extract from Steps 1 to 4, concentrate under reduced pressure to a thick paste with a relative density of 1.30 to 1.35 (50°C), vacuum dry, pulverize, add micronized silica gel, dextrin and the above volatile oil inclusions, mix well, form into granules, and fill into capsules or tablets to obtain the final product. Example

[0056] Prescription: 30 parts raw oyster shell, 15 parts scrophularia, 15 parts Zhejiang fritillary bulb, 10 parts cat's claw herb, 15 parts vinegar-processed turtle shell, 15 parts stir-fried silkworm pupae, 10 parts stir-fried mustard seed, 10 parts processed pinellia, 15 parts codonopsis, 10 parts vinegar-processed turmeric, 15 parts rhodiola rosea, 10 parts bee honeycomb, 30 parts lily bulb, 15 parts dried plum, 15 parts Ganoderma lucidum, 10 parts stir-fried bitter almond, 15 parts honey-processed mulberry bark, 10 parts scutellaria baicalensis, 5 parts toad venom.

[0057] Step 1: Take vinegar-processed Curcuma zedoaria, add 10 times the amount of water, and extract the volatile oil by steam distillation. Collect the volatile oil for later use, and separately collect the aqueous solution for later use. Keep the residue for later use.

[0058] Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds. Use 10 times 80% ethanol to reflux and extract twice, 1 hour each time. Filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.2 (50℃). Set aside for later use. Set aside the dregs for later use.

[0059] Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria root to the dregs from step 3 and step 2. Decoct twice with water (10 and 8 times the amount), 1.5 hours each time. Filter the decoction in batches and combine the filtrates.

[0060] Step 4: Take toad venom, crush it, and soak it thoroughly in 7 times weak acid water / purified water at room temperature. Wash and filter it 5 times. Take the residue and extract it once by reflux with 7 times 100% ethanol for 1 hour each time. Filter it, recover the ethanol from the filtrate, and keep the extract for later use.

[0061] Step 5: Take the volatile oil and extract from Steps 1 to 4, add an appropriate amount of excipients, and mix thoroughly to obtain the oral liquid or granule formulation of the traditional Chinese medicine composition of the present invention.

[0062] Example 7: Observation and case studies on the effects of the composition of the present invention on pulmonary nodules in volunteers. 7.1 General Information The volunteers were 60 patients diagnosed with pulmonary nodules at the hospital between June 2023 and July 2024. They were randomly divided into two groups of 30 each.

[0063] Control group: 20 males and 10 females, aged 33 to 70 years, with a mean age of 45.84 ± 6.89 years; nodule diameter ranged from 5 to 11 mm, with a mean of 6.83 ± 1.35 mm.

[0064] Volunteer group: 23 males and 7 females, aged 35 to 69 years, with a mean age of 44.53 ± 6.85 years; lung nodules diameter 4 to 10 mm, with a mean of 6.91 ± 1.47 mm.

[0065] 7.2 Observation Methods The volunteer group used Example 5 of the present invention, taking it three times a day (morning, noon, and evening) for 30 consecutive days.

[0066] The control group received a placebo, which was similar in appearance, color, and shape to that of Example 5, but did not contain the active ingredient of Example 5. The active ingredient was selected as microcrystalline cellulose and starch, which had no pharmacological activity and good safety. It was taken three times a day, morning, noon and evening, for 30 consecutive days.

[0067] 7.3 Observation Indicators To observe the size of the lung nodules, volunteers went back to their original medical institutions for examination of the lung nodules to check the condition of the lung nodules before and after using this invention.

[0068] 7.4 Treatment Results Table 1. Lung nodule clearance rate after treatment in the two groups (%) Group example Number of lung nodules eliminated after treatment (people) Clearance rate (%) control group 30 0 0 Volunteer Group 30 23 76.67 Table 2. Comparison of the diameter of pulmonary nodules that were not cleared before and after treatment in the two groups (mm, x±s) Group example Before treatment (mm) Post-treatment (mm) control group 30 6.83±1.35 6.82±1.34 Volunteer Group 7 9.32±1.94 4.30±1.02 7.5 Examples of Case Studies The patient, a 55-year-old male, first visited on July 17, 2024. A chest CT scan was performed. Imaging findings: The chest was symmetrical; no abnormalities were seen in the ribs or chest wall soft tissues. Lung markings were clear and naturally arranged; lung lobes had good translucency. A nodule measuring approximately 11 x 9 mm was observed in the left lower lung, with a pale and uneven density. A pale-density, fine nodule was also observed in the subpleural region of the left lower leg. A few blurred shadows were present in the subpleural region of both lower lungs. The hilum of both lungs were not enlarged. There was no longitudinal displacement; the heart and great vessels appeared normal in shape, and no enlarged nodes were seen in the longitudinal region. No pleural effusion or pleural thickening was observed. Imaging diagnosis: 1. Pale-density nodules and small nodules in the left lower lung. 2. A few inflammatory changes in the subpleural region of both lower lungs.

[0069] Volunteers used Example 5 of the present invention, taking it three times a day (morning, noon, and evening) for 30 consecutive days. During the medication period, they avoided spicy and irritating foods, refrained from smoking and limited alcohol consumption, and ensured sufficient sleep.

[0070] Thirty days later (August 26, 2024), a follow-up chest CT scan was performed. Imaging findings: The chest was symmetrical, and no abnormalities were seen in the ribs or chest wall soft tissues. The lung markings were clear and naturally arranged, with good lung lobes. The previous nodule in the left lower lung had disappeared. The faint, fine nodule in the left lower pleural crura had disappeared. The subpleural areas of both lower lungs were clear. The hilum of both lungs were not enlarged. There was no longitudinal deviation. The heart and great vessels appeared normal in shape, and no enlarged nodes were seen in the longitudinal region. No pleural effusion or pleural thickening was observed.

[0071] The patient's lung nodules were completely cleared, and he recovered.

[0072] The above-mentioned traditional Chinese medicine composition has the functions of resolving phlegm and removing blood stasis, attacking toxins and dispersing nodules, invigorating qi and promoting qi circulation, and nourishing yin and moistening the lungs. It is safe and effective for treating pulmonary nodules.

[0073] This traditional Chinese medicine composition can fill the gap in clinical treatment drugs. The raw materials of the medicine described in this invention are of high quality and readily available, with definite curative effect. It has the advantages of being simple, efficient, safe, low cost, easy to operate, highly scalable, and with broad application prospects.

[0074] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

[0075] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for lung nodules and a preparation method thereof, characterized in that, It is prepared from the following components in parts by weight: 6-30 parts raw oyster shell, 3-15 parts scrophularia, 3-15 parts Fritillaria thunbergii, 2-10 parts Uncaria rhynchophylla, 3-15 parts vinegar-processed turtle shell, 3-15 parts stir-fried silkworm pupae, 2-10 parts stir-fried mustard seeds, 2-10 parts processed Pinellia ternata, 3-15 parts Codonopsis pilosula, 2-10 parts vinegar-processed Curcuma zedoaria, 3-15 parts Rhodiola rosea, 2-10 parts bee honeycomb, 6-30 parts lily bulb, 3-15 parts dried plum, 3-15 parts Ganoderma lucidum, 2-10 parts stir-fried bitter almond, 3-15 parts honey-processed mulberry bark, and 2-10 parts Scutellaria baicalensis.

2. The traditional Chinese medicine composition for pulmonary nodule according to claim 1, characterized in that, It also includes the following medicinal materials in parts by weight: toad venom 0.001 to 5 parts.

3. A method of preparing the traditional Chinese medicine composition for pulmonary nodule according to any one of claims 1, characterized in that Includes the following steps: Step 1: Weigh the Chinese herbal composition according to the weight proportions in claims 1-2 for later use; extract the volatile oil from the vinegar-processed Curcuma zedoaria for later use; collect the aqueous solution for later use; and keep the residue for later use. Step 2: Take the dregs from Step 1, add cat's claw grass, stir-fried mustard seeds, rhodiola rosea, honeycomb, lily, Ganoderma lucidum, and stir-fried bitter almonds, extract with ethanol, recover the ethanol from the filtrate, and set aside. Set aside the dregs. Add raw oyster shell, scrophularia root, fritillaria thunbergii, cat's claw herb, vinegar-processed turtle shell, stir-fried silkworm pupae, prepared pinellia tuber, codonopsis root, dried plum, honey-processed mulberry bark, and scutellaria baicalensis to the dregs from step 3 and step 2, decoct with water, filter, combine the filtrates, and set aside. Step 4: Take the aqueous solution from Step 1 and the filtrate from Steps 2 and 3, concentrate them to obtain a thick paste, dry it, pulverize it, add the auxiliary agent and the volatile oil inclusion complex from Step 1, mix them well, and then prepare different dosage forms.

4. The production method according to claim 3, characterized by, In step 2, use 5 to 15 times the amount of 60 to 90% ethanol to reflux and extract 1 to 3 times, each time for 1 to 3 hours.

5. The preparation method according to claim 4, characterized in that, In step 3, add 5 to 15 times the amount of water and boil 1 to 3 times, each time for 1 to 3 hours.

6. A traditional Chinese medicine composition for pulmonary nodules and a method for preparing it, as described in any one of claims 1 to 2, for use in pharmaceuticals or health products for pulmonary nodules.