Traditional Chinese medicine composition for treating pulmonary nodule as well as preparation, preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating pulmonary nodule as well as a preparation, a preparation method and application thereof. The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 30-45 parts of oyster, 15-30 parts of selfheal, 10-15 parts of radix scrophulariae, 10-15 parts of thunberg fritillary bulb, 10-15 parts of dandelion, 10-15 parts of curcuma zedoary and 5-10 parts of pseudobulbus cremastrae seu pleiones. The traditional Chinese medicine composition for treating the phlegm-heat stagnation type pulmonary nodules has the effects of clearing heat, eliminating phlegm, removing blood stasis and eliminating stagnation, is obvious in clinical effect, has a reliable empirical basis, and is expected in economic and social benefits.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating pulmonary nodules, a preparation thereof, a preparation method and an application thereof. Background Art

[0002] In recent years, with the popularization of physical examination awareness and the improvement of CT resolution, the detection rate of lung nodules has increased significantly. Most of them are benign nodules, and some are malignant, progressing rapidly and with poor prognosis, which has attracted people's attention. At present, the intervention methods of Western medicine for lung nodules are mainly imaging follow-up, in addition to empirical antibacterial treatment, local thermal ablation, surgical operation and other treatment methods. Due to the lack or inaccuracy of professional information, many patients equate lung nodules with lung cancer, which leads to anxiety and fear, which is not beneficial to the condition. Some patients with benign nodules will also take radical treatments such as surgery and intervention, and the complications and adverse reactions caused by the treatment, such as pneumonia, postoperative pain, and decreased lung function, seriously affect the quality of life of patients. This is avoidable. Therefore, it is necessary to reduce overdiagnosis and treatment. According to the "Chinese Expert Consensus on the Diagnosis and Treatment of Lung Nodules", the incidence and mortality of lung cancer in my country are both high. Therefore, early diagnosis and treatment are crucial to improving the five-year survival rate and prognosis of patients. Given that lung nodules are often early signs of lung cancer, the market demand for its treatment and prevention is particularly urgent. Clinical practice has proved that traditional Chinese medicine has unique advantages in the health management of patients with lung nodules.

[0003] The diagnostic concept of pulmonary nodules was discovered and defined with the advancement of medical imaging technology. There is no corresponding disease name in traditional Chinese medicine. According to symptoms and space-occupying properties, it can be classified into categories such as cough, phlegm nodules, and accumulated diseases. There are many different opinions on its etiology and pathogenesis. Professor Zhang Zhiwen proposed that the key to the pathogenesis of pulmonary nodules lies in the imbalance of qi, blood, body fluids, disharmony of internal organs, abnormal opening and closing of the Xuanfu, poor distribution of body fluids, phlegm and blood stasis, and long-term accumulation of toxins; Professor Yuan Changjin believes that the fundamental reason for the formation of pulmonary nodules is the deficiency of yang qi, which fails to transform into qi, resulting in the accumulation of tangible evil qi such as qi, blood stasis, phlegm, and fire in the lungs; Professor Jiang Liangduo pointed out that the main pathogenesis of pulmonary nodules is deficiency of righteous qi, stagnation of qi and dampness, phlegm and blood stasis, and accumulation and obstruction. Different doctors have different understandings of this, resulting in the lack of effective Chinese medicine combination for the treatment of pulmonary nodules. Summary of the invention

[0004] In view of the above problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating pulmonary nodules, a preparation thereof, a preparation method and an application thereof.

[0005] The technical solution of the present invention is as follows:

[0006] The first object of the present invention is to provide a Chinese medicine composition for treating pulmonary nodules, wherein the Chinese medicine raw materials are in the following weight ratio:

[0007] 30-45 parts of oyster, 15-30 parts of selfheal, 10-15 parts of figwort, 10-15 parts of thunbergia thunbergii, 10-15 parts of dandelion, 10-15 parts of zedoaria and 5-10 parts of trillium.

[0008] In one embodiment of the present invention, the raw materials of the Chinese medicine composition for treating pulmonary nodules are as follows by weight:

[0009] 45 parts of oysters, 30 parts of selfheal, 15 parts of figwort, 15 parts of fritillaria thunbergii, 15 parts of dandelions, 15 parts of zedoary zedoary and 10 parts of trillium.

[0010] The second object of the present invention is to provide a Chinese medicine preparation prepared from the above-mentioned Chinese medicine composition, wherein the Chinese medicine preparation is a liquid preparation or a solid preparation.

[0011] In one embodiment of the present invention, the liquid preparation is a decoction or a mixture.

[0012] In one embodiment of the present invention, the solid preparation is one of tablets, capsules and granules.

[0013] In one embodiment of the present invention, the above-mentioned traditional Chinese medicine preparation contains pharmaceutical excipients.

[0014] In one embodiment of the present invention, the pharmaceutical excipient is one or more of sucrose, dextrin, starch and lactose.

[0015] The third object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine preparation, comprising the following steps: each raw material is measured in parts by weight;

[0016] Accurately weigh 30-45 parts of oysters, 15-30 parts of Prunella Vulgaris, 10-15 parts of Scrophularia, 10-15 parts of Fritillaria, 10-15 parts of Taraxacum, 10-15 parts of Curcuma and 5-10 parts of Tripterygium wilfordii;

[0017] Soak the above raw materials in cold water for 30-60 minutes, add water in an amount that is 2-3 cm above the surface of the medicinal materials, and decoct twice. The first decoction is boiled and decocted for 20-25 minutes. After the decoction is finished, filter the residue to obtain the first decoction juice; the second decoction is to add water to the residue and decoct for 15-20 minutes, and filter the residue to obtain the second decoction juice;

[0018] Combine the two decoctions to make a decoction.

[0019] In one embodiment of the present invention, the two decoctions are combined and concentrated, the concentrated extract is dried into powder, excipients are added, and the extract is compressed or made into granules, namely tablets or granules.

[0020] The fourth object of the present invention is to provide a use of a traditional Chinese medicine preparation in the preparation of a medicine for treating pulmonary nodules.

[0021] In the present invention application, it is believed that pulmonary nodules are diseases, or due to the infiltration of six evils, improper diet, emotional disorder, and insufficient endowment, resulting in dysfunction of the lung, liver, spleen and other internal organs, stagnation of lung qi, dysfunction of the descending and ascending functions, unfavorable qi mechanism, obstruction of blood circulation, accumulation of body fluid into phlegm, stagnation of blood into blood stasis, and mutual obstruction of phlegm and blood stasis, which form lumps and tumors over time. Based on this, a medicine for treating pulmonary nodules of phlegm-heat stagnation type is provided.

[0022] Usage: Take in the morning and evening, 3 months as a course of treatment.

[0023] Among the above drugs,

[0024] Oyster, this product is the shell of the long oyster Ostrea gigas Thunberg, Dalian Bay oyster OstreatalienwhanensisCrosse or Ostrea rivularis Gould. It tastes salty and is slightly cold. It calms the mind, subdues yang and replenishes yin, softens and disperses nodules. It is used for palpitations, insomnia, vertigo, tinnitus, scrofula, phlegm nodules, and lumps.

[0025] Prunella vulgaris, this product is the dried fruit spike of Prunella vulgaris L., a plant of the Labiatae family. It tastes pungent and bitter, and is cold in nature. It clears away internal heat and improves eyesight, dissipates stagnation and reduces swelling. It is used for red and swollen eyes, headache, scrofula, goiter, and breast abscess.

[0026] Scrophularia ningpoensis, this product is the dried root of Scrophularia ningpoensis Hensl., a plant of the Scrophulariaceae family. It tastes sweet, bitter, and salty, and is slightly cold in nature. It clears away heat and cools blood, nourishes yin and reduces fire, and detoxifies and disperses stagnation. It is used for warm pathogens entering the Ying, invading the pericardium, warm toxins causing spots, febrile diseases damaging the yin, red tongue and thirst, body fluid damage and constipation, bone steaming and fatigue cough, sore throat, scrofula and sputum nodules, sores, carbuncles, and swelling.

[0027] Fritillaria thunbergii Miq., a plant of the Liliaceae family, is a dried bulb. It tastes bitter and is cold in nature. It clears away heat and resolves phlegm, dissipates stagnation and detoxifies. It is used for wind-heat cough, lung abscess, throat paralysis, scrofula, and sores and swelling.

[0028] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz. of the Asteraceae family. It tastes sweet and slightly bitter, and is cold in nature. It clears away heat and detoxifies, and relieves swelling and resolves stagnation. It is used for sores, carbuncle, swelling, damp-heat jaundice, and painful stranguria caused by heat.

[0029] Curcuma phaeocaulis Val. is a dried root of the ginger family plant. It tastes pungent and bitter, and is warm in nature. It can dispel blood stasis, promote qi circulation and relieve pain. It is used for treating abdominal masses, amenorrhea due to blood stasis, chest pain, food stagnation and qi stagnation, and abdominal distension and pain.

[0030] Cremastra appendiculata (D. Don) Makino is a dried pseudobulb of Cremastra appendiculata (D. Don) Makino, an orchidaceae plant. It tastes sweet, slightly spicy, and cool; it is slightly toxic. It clears away heat and detoxifies, resolves phlegm and dissipates stagnation. It is used for sore throat, scrofula, carbuncle, sore swelling, and postpartum stasis.

[0031] The beneficial technical effects of the present invention are:

[0032] ① Examine the pathogenesis, phlegm, blood stasis and heat accumulation: There is no clear name for lung nodules in traditional Chinese medicine. Combined with clinical experience, it is proposed that the pathogenesis of lung nodules is the dysfunction of the lungs, liver, spleen and other internal organs, and the interweaving of phlegm, blood stasis and heat toxins.

[0033] ② Simplified formula, innovative development: The Chinese medicine composition of the present invention is composed of oyster, Prunella vulgaris, Scrophularia ningpoensis, Fritillaria thunbergii, Taraxacum officinale, Curcuma zedoaria and Tripterygium wilfordii. Oyster, Fritillaria ningpoensis and Scrophularia ningpoensis in the formula can clear away heat, resolve phlegm and dissipate nodules; Prunella vulgaris can clear liver fire and dissipate depression; "Ben Cao Yan Yi Buyi" says that dandelion can "resolve heat and toxins, eliminate malignant tumors and tuberculosis, resolve food poisoning, and disperse stagnant qi"; long-term illness enters the collaterals, and phlegm and fire condense for a long time, qi and blood flow is not smooth, blood stasis blocks the collaterals, leading to aggravated accumulation, Curcuma zedoaria is good at opening the hard nodules, promoting blood circulation and removing blood stasis, breaking blood and promoting qi circulation, qi and blood flow smoothly, and nodules disappear by themselves; Tripterygium wilfordii enters the liver and spleen meridians, and "Ben Cao Shi Yi" says that it "mainly treats carbuncle, sore, fistula, scrofula and tuberculosis, etc.", which helps oyster soften and dissipate nodules, and studies have shown that it has good anti-tumor activity and can prevent nodular cancer transformation.

[0034] The Chinese medicine composition of the present invention has the functions of clearing away heat and resolving phlegm, removing blood stasis and dispersing nodules, so that phlegm and blood stasis have no place to gather and fire toxins have no place to stay, thereby promoting the smooth flow of qi and blood, restoring the lung's function of clearing and purging, dispersing nodules and relieving symptoms; it focuses on blood stasis, and in addition to increasing the power of resolving phlegm in the treatment, it is combined with products that can remove blood stasis, detoxify and disperse nodules.

[0035] ③ Confirmation of efficacy and scientific support: Preliminary clinical observations have confirmed that the present invention has unique advantages in the treatment of lung nodules, has good clinical efficacy and safety, can improve the clinical symptoms of patients with lung nodules of phlegm-heat stagnation syndrome, and the maximum diameter of the lung nodules is smaller after taking traditional Chinese medicine than before (P < 0.05). DETAILED DESCRIPTION

[0036] The present invention will be described in detail below in conjunction with the embodiments.

[0037] The principles and features of the present invention will be described in detail below through embodiments. The examples listed are only used to illustrate the present invention and do not limit its scope of application. Any technology implemented based on the content of the present invention belongs to the scope of the present invention.

[0038] Embodiment 1:

[0039] A Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0040] Mix 45g of oyster, 30g of Prunella Vulgaris, 15g of Scrophularia, 15g of Fritillaria Thunbergii, 15g of Taraxacum, 15g of Curcuma and 10g of Trillium, add water to cover the surface of the medicinal materials by 2cm, and soak in cold water for 30min; then decoct twice, boil the first decoction and then simmer for 20min, filter the residue after the end to obtain the first decoction; add water to the residue for the second decoction and boil for 15min, filter the residue to obtain the second decoction.

[0041] Combine the two decoctions and prepare a decoction. Usage: 1 dose per day, 1 dose totaling 400 mL, divided into two doses, morning and evening, 200 mL each time, taken warm after meals, 3 months as a course of treatment.

[0042] Embodiment 2:

[0043] A Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0044] Take 30g of oyster, 30g of Prunella Vulgaris, 12g of Scrophularia, 12g of Fritillaria Thunbergii, 12g of Taraxacum, 10g of Curcuma and 10g of Trillium, mix them, add water to cover the surface of the medicinal materials by 2cm, and soak them in cold water for 30min; then decoct them twice, boil the first decoction and then decoct for 25min, filter the residue after the end to obtain the first decoction; add water to the residue for the second decoction and decoct for 15min, filter the residue to obtain the second decoction.

[0045] Combine the two decoctions and concentrate them. The concentrated extract is dried into powder, and excipients are added to prepare granules. Usage: Take one dose per day, 200 mL of boiled water per dose, twice a day, warm after meals, and one course of treatment is 3 months.

[0046] Embodiment 3:

[0047] A Chinese medicine preparation for treating pulmonary nodules comprises the following steps:

[0048] Mix 30g of oyster, 15g of Prunella Vulgaris, 15g of Scrophularia, 10g of Fritillaria Thunbergii, 10g of Taraxacum, 12g of Curcuma and 5g of Trillium, add water to cover the surface of the medicinal materials by 2cm, and soak in cold water for 45min; then decoct twice, boil the first decoction and then simmer for 25min, filter the residue after the end to obtain the first decoction; decoct the second decoction by adding water to the residue and decocting for 20min, filter the residue to obtain the second decoction.

[0049] Combine the two decoctions and prepare a decoction. Usage: 1 dose per day, 1 dose totaling 400 mL, divided into two doses, morning and evening, 200 mL each time, taken warm after meals, 3 months as a course of treatment.

[0050] Clinical observations related to the medicament obtained in Example 1

[0051] 1. Research methods and efficacy evaluation criteria

[0052] The cases were from 69 patients diagnosed with pulmonary nodules and phlegm-heat stagnation syndrome by lung CT in the outpatient department of the Department of Oncology, Wuxi Traditional Chinese Medicine Hospital from September 1, 2022 to October 31, 2024. The inclusion criteria are patients who meet the Western medicine diagnosis criteria for pulmonary nodules, the Chinese medicine phlegm-heat obstruction lung syndrome differentiation criteria, and have taken the medicament of the present invention for more than 3 months. At the same time, patients with serious primary diseases such as heart, liver, and kidney, less than 3 months of treatment time, and incomplete medical records that cannot evaluate the efficacy are excluded. Each patient took the decoction prepared in Example 1 of the present invention orally, 1 dose per day, 400 mL for 1 dose, divided into two doses in the morning and evening, 200 mL each time, warm after meals, and the course of treatment is 3 months. After 3 months, the patient reviewed CT.

[0053] The observation indicators include the general information of the patients, such as gender, age, smoking history, and efficacy observation indicators. The efficacy observation indicators specifically include: ① Lung-RADS grade, size, and density of lung nodules. The maximum diameter and density of lung nodules are measured by chest high-resolution CT, and the Lung-RADS grade is recorded once before and after treatment; ② TCM syndrome score. The main clinical symptoms of patients, including foreign body sensation in the throat, dry mouth, cough, sputum, chest tightness, etc., are observed, and a semi-quantitative grade scoring evaluation method is used. The main symptoms are counted as 0, 2, 4, and 6 points respectively for absence, mild, moderate, and severe, and 0, 1, 2, and 3 points respectively for absence, mild, moderate, and severe secondary symptoms. The score is recorded once before and after treatment, and the pulse is not scored.

[0054] The efficacy evaluation method is as follows:

[0055] ① Efficacy of reduction of maximum diameter of nodules: If the lung nodules completely disappear, it is defined as clinical cure; if the maximum diameter of the nodules is reduced by more than 50%, it is evaluated as markedly effective; if the reduction of the maximum diameter of the nodules is between 25% and 50%, it is considered effective; if the maximum diameter of the nodules is reduced by less than 25% but has not increased, the condition is considered stable; if the maximum diameter of the nodules is increased compared to before, it is judged as ineffective. The calculation formula for the effective rate is: (number of clinically cured cases + number of markedly effective cases + number of effective cases) / total number of cases * 100%.

[0056] ②Evaluation of the efficacy of nodule Lung-RADS grade: When the nodule completely disappears, it is defined as clinical cure; when the nodule Lung-RADS grade is lower than before, it is considered effective; when the nodule grade remains unchanged, it is considered to be a stable state; if the nodule grade is higher than before, it is considered ineffective. Total effective rate = (number of clinically cured cases + number of effective cases) / total number of cases * 100%.

[0057] ③ TCM syndrome score efficacy: The efficacy index was calculated using the nimodipine method to compare the total scores before and after treatment. The efficacy index ≥ 70% was markedly effective, 30% ≤ efficacy index < 70% was effective, and efficacy index < 30% was ineffective. Total effective rate = (markedly effective + effective) / total number of cases × 100%.

[0058] The count data and rank data were described by frequency (%) and Wilcoxon rank sum test was used; the measurement data were described by mean ± standard deviation and t test when they were in accordance with normal distribution, and the median was used when they were not in accordance with normal distribution (P 25 , P 75 ) description, and the Wilcoxon rank sum test was used.

[0059] 2 Results

[0060] 2.1 General Information

[0061] All cases were diagnosed with pulmonary nodules by chest CT at the time of consultation. All cases were diagnosed with phlegm-heat stagnation syndrome by TCM differentiation. No empirical antibacterial treatment, local thermal ablation, etc. were received. There were 20 males and 49 females in this group; 5 cases were aged 20-39 years, 37 cases were aged 40-59 years, 24 cases were aged 60-79 years, and 3 cases were 80 years and above. 39 cases had a history of tumor. See Table 1.

[0062] Table 1 General information of patients

[0063]

[0064]

[0065] 2.2 Comparison of efficacy

[0066] 2.2.1 Comparison of the maximum diameter of nodules before and after treatment

[0067] After treatment, the nodules were smaller than before treatment, and the difference was statistically significant (P<0.05), as shown in Table 2. The total effective rate of the clinical efficacy of the maximum diameter reduction of lung nodules after taking Chinese medicine was 7.25%, as shown in Table 3.

[0068] Table 2 Comparison of the maximum diameter of lung nodules before and after treatment (mm)

[0069]

[0070] Table 3 Effect of reducing the maximum diameter of pulmonary nodules (cases)

[0071] time Number of cases get well Significant effect efficient Stablize invalid Total Effectiveness After treatment 69 1 1 3 63 1 7.25％

[0072] 2.2.2 Comparison of Lung-RADS grades of pulmonary nodules before and after treatment

[0073] Before treatment, 24 patients had lung nodules with Lung-RADS grade 2, 27 with grade 3, 15 with grade 4A, 2 with grade 4B, and 1 with grade 5, as shown in Table 4. After treatment, 1 patient had complete recovery of lung nodules, and the Lung-RADS grade was reduced to grade 2 in 26 patients, grade 3 in 26 patients, grade 4A in 13 patients, grade 4B in 2 patients, and grade 5 in 1 patient, as shown in Table 5. The total effective rate after taking the medicine was calculated to be 4.35%, as shown in Table 6.

[0074] Table 4 Comparison of the largest pulmonary nodule grade before treatment (cases)

[0075] time Number of cases 2 3 4A 4B 5 Before treatment 69 24 27 15 2 1

[0076] Table 5 Comparison of the largest lung nodule grade after treatment (examples)

[0077] time Number of cases none 2 3 4A 4B 5 After treatment 69 1 26 26 13 2 1

[0078] Table 6 Comparison of the efficacy of the largest lung nodule grade after treatment (cases)

[0079] Number of cases get well efficient Stablize invalid Total Effectiveness 69 1 2 66 0 4.35％

[0080] 2.2.3 Comparison of TCM syndrome scores before and after treatment

[0081] After treatment, the TCM syndrome score was significantly lower than that before treatment, and the difference was statistically significant (P<0.001), as shown in Table 7. The total effective rate of TCM syndrome clinical efficacy after taking Chinese medicine was 85.96%, as shown in Table 8.

[0082] Table 7 Comparison of TCM syndrome scores before and after treatment (points)

[0083]

[0084] Table 8 Comparison of clinical efficacy of TCM syndromes after treatment (cases)

[0085] time Number of cases Significant effect efficient invalid Total Effectiveness After treatment 69 14 46 9 86.96％

[0086] 2.3 Summary

[0087] This clinical observation aims to explore the efficacy and safety of the medicament of the present invention in treating pulmonary nodules. The results show that the maximum diameter of pulmonary nodules after taking Chinese medicine is smaller than before (P<0.05), and the total effective rate is 7.25%; the total effective rate of Lung-RADS grade efficacy of pulmonary nodules after taking the medicine is calculated to be 4.35%; although the total effective rate of nodule reduction and grade efficacy is not high, the composition is observed and it is found that the proportion of stable patients is relatively large, which shows that the medicament of the present invention has a certain effect in controlling the progression of pulmonary nodules. Although the efficiency of shrinking pulmonary nodules is limited, it can maintain the stability of the disease, which is of great significance for preventing further deterioration of pulmonary nodules and possible canceration, which may gain more treatment time and options for patients. In addition, in terms of the improvement of clinical symptoms of traditional Chinese medicine, the treatment after treatment is significantly better than before treatment (P<0.001), and the total effective rate is 85.96%, indicating that the Chinese medicine of the present invention is effective in improving related symptoms. Since this study is an outpatient observation, no reports on adverse reactions have been received so far. However, due to the limitations of the observation items and time, these preliminary results need to be further verified in larger-scale and longer-term studies to ensure the comprehensiveness of the evaluation and the reliability of the conclusions.

[0088] Example 2 Clinical cases related to the obtained drug

[0089] ① Wang, male, 59 years old, rectal cancer surgery, postoperative pathology: adenocarcinoma, no invasion of blood vessels and nerves, no lymph node metastasis, no postoperative radiotherapy or chemotherapy. 2023-04-23 CT showed multiple nodules in the lungs, the largest of which was ground glass, with a long diameter of about 6mm. 2023-05-07 came for treatment, and the following findings were seen during the visit: night sweats, bitter taste in the mouth in the morning, slightly dry mouth, coughing up sputum, yellow in color, occasional coolness in the shoulders and back, good appetite, normal two times, poor sleep at night, no chest tightness, irritability and other symptoms, red tongue with cracks in the middle, white greasy fur, and a stringy and slippery pulse.

[0090] Orally take the granules prepared in Example 2 of the present invention, 1 dose per day, 1 dose of 200mL boiled water, divided into two doses of warm after meals in the morning and evening. CT examination on 2023-09 showed multiple small nodules in both lungs, the largest of which was ground glass, with a long diameter of about 5mm. Later, on 2023-09-11, the patient went to the doctor and showed that the bitter taste in the morning and poor sleep at night were improved compared with the previous ones, with occasional coolness in the shoulders and back, good appetite, two times normal, no symptoms such as coughing and sputum, chest tightness, irritability, etc., the tongue was red with cracks in the middle, thin white fur, and stringy pulse.

[0091] ② Hu Moumou, female, 54 years old, reported during outpatient consultation on 2024-05-26 that a solid lung nodule was found on a recent CT scan, with a long diameter of about 7mm. During the consultation, she had the following symptoms: fatigue, bitter taste in the mouth, good appetite, dry stool, normal sleep at night, no symptoms such as coughing and sputum, chest tightness, irritability, etc. The tongue was dark red, the tongue coating was thin and greasy, and the pulse was stringy and slippery.

[0092] Orally take the granules prepared in Example 2 of the present invention, 1 dose per day, 1 dose of 200 mL of boiled water, divided into two doses, morning and evening, warm after meals. Later, on 2024-08-21, the patient reported that CT examination found that the long diameter of the lung nodule was reduced from 7 mm to 3-4 mm, the bitter taste in the mouth and dry stool were improved compared with before, and the other symptoms were similar to before, the tongue was dark, the tongue coating was thin and white, and the pulse was stringy.

[0093] Example 3 Clinical cases related to the obtained drug

[0094] ① Guo, male, 45 years old, underwent surgery for lung cancer. On 2023-01-26, a postoperative CT scan revealed a lung nodule with a long diameter of less than 5mm. He came to the hospital for treatment on 2023-04-17. During the visit, he had poor sleep at night, obvious bitter taste in the mouth at night, good appetite, regular bowel movements, no symptoms such as chest tightness, shortness of breath, cough and sputum, red tongue, thin white greasy coating, and a wiry and slippery pulse.

[0095] The decoction prepared in Example 3 of the present invention was taken orally, 1 dose per day, 1 dose of 200 mL of boiled water, divided into two doses, warm after meals in the morning and evening. Later, on 2023-08-14, the lung nodules were reduced to 3 mm. The patient complained of poor sleep at night, good appetite, regular bowel movements, no symptoms such as chest tightness and asthma, cough and sputum, bitter taste in the mouth, etc. The tongue was pale with cracks, the tongue coating was thin and white, and the pulse was thin.

[0096] ② Ms. Weng, female, 69 years old, was found to have solid nodules in both lungs on CT scan on January 15, 2024, with the largest long diameter of about 7mm. She came to the hospital for treatment on February 18, 2024. During the visit, she was found to have: fatigue, slight cough, chest tightness and palpitations, bitter taste in the mouth, poor sleep at night, good appetite, regular bowel movements, no symptoms such as coughing up sputum and asthma, dark tongue, thin white greasy tongue coating, and slippery and stringy pulse.

[0097] Orally take the decoction prepared in Example 3 of the present invention, 1 dose per day, 1 dose of 200 mL of boiled water, divided into two doses, morning and evening, warm after meals. After 2024-04-25, the lung nodules were found to be reduced, with the maximum long diameter of about 3.2 mm. On 2024-05-10, the patient complained of cough, chest tightness and palpitations, fatigue, poor sleep at night, no sputum, asthma and other symptoms, pale tongue, thin white fur, and thin and stringy pulse.

[0098] The embodiments provided above are not intended to limit the scope of the present invention, and the steps described are not intended to limit the execution order thereof. Those skilled in the art may make obvious improvements to the present invention in combination with existing common knowledge, which also fall within the scope of protection defined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating pulmonary nodules, characterized in that: The weight ratio of the Chinese medicine raw materials is: 30-45 parts of oyster, 15-30 parts of selfheal, 10-15 parts of figwort, 10-15 parts of thunbergia thunbergii, 10-15 parts of dandelion, 10-15 parts of zedoaria and 5-10 parts of trillium.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight ratio of the Chinese medicinal materials is as follows: 45 parts of oyster, 30 parts of selfheal, 15 parts of Scrophularia, 15 parts of Fritillaria thunbergii, 15 parts of dandelion, 15 parts of Curcuma zedoaria and 10 parts of Trillium.

3. A Chinese medicine preparation prepared from the Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine preparation is a liquid preparation or a solid preparation.

4. The Chinese medicine preparation according to claim 3, characterized in that: Liquid preparations are decoctions and mixtures; solid preparations are tablets, capsules, and granules.

5. The Chinese medicine preparation according to claim 3, characterized in that: Contains pharmaceutical excipients.

6. The Chinese medicine preparation according to claim 5, characterized in that: The pharmaceutical excipients are one or more of sucrose, dextrin, starch and lactose.

7. A method for preparing the Chinese medicine preparation according to claim 3, characterized in that: The method comprises the following steps: each raw material is measured by weight; Accurately weigh 30-45 parts of oysters, 15-30 parts of Prunella Vulgaris, 10-15 parts of Scrophularia, 10-15 parts of Fritillaria, 10-15 parts of Taraxacum, 10-15 parts of Curcuma and 5-10 parts of Tripterygium wilfordii; Soak the above raw materials in cold water for 30-60 minutes, add water in an amount that is 2-3 cm above the surface of the medicinal materials, and decoct twice. The first decoction is boiled and decocted for 20-25 minutes. After the decoction is finished, filter the residue to obtain the first decoction juice; the second decoction is to add water to the residue and decoct for 15-20 minutes, and filter the residue to obtain the second decoction juice; Combine the two decoctions to make a decoction.

8. The preparation method according to claim 7, characterized in that: The two decoctions are combined and concentrated, and the concentrated extract is dried into powder, added with auxiliary materials, and compressed or made into granules to obtain tablets or granules.

9. Use of the traditional Chinese medicine preparation according to claim 3 in preparing medicine for treating pulmonary nodules.

Images