Traditional Chinese medicine composition for treating phlegm stasis type pulmonary nodule and preparation method thereof

Through a traditional Chinese medicine composition containing a variety of Chinese medicine ingredients, it can eliminate phlegm and promote blood circulation, promote qi and disperse nodules, and solve the problem of the side effects and insignificant efficacy of the existing methods for treating phlegm and blood stasis blocking lung nodules, achieving high efficiency and safety therapeutic effect.

CN119424592AActive Publication Date: 2025-02-14AFFILIATED HOSPITAL OF JIANGXI UNIV OF TCM
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Patent Information

Application Number
CN202510019640.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-07
Publication Date
2025-02-14
Estimated Expiration
2045-01-07

AI Technical Summary

Technical Problem

The existing methods for treating phlegm-stasis blocked lung nodules have side effects or insignificant efficacy, and there is a lack of a treatment plan with obvious clinical efficacy and few side effects.

Method used

Provided is a traditional Chinese medicine composition, including tangerine peel, Pinellia ternata, Poria cocos, peach kernel, quartz, Wangbuli, cat claw grass, Curcuma zedo, Coix seed, barbed lotus and licorice, through synergistic action, to eliminate phlegm and promote blood circulation, and to promote qi and sanitary septicism and promote blood circulation and to promote qi and sanitary septicism. Nodules, treat pulmonary nodules with phlegm and blood stasis blocking.

Benefits of technology

This traditional Chinese medicine composition has the characteristics of treating both symptoms and root causes, few side effects, high efficiency, good effect and low cost. It significantly improves the clinical efficacy of phlegm and blood stasis blocking lung nodules, and it also changes phlegm and blood stasis to heat and toxic lung nodules over time. The nodes also have significant therapeutic effects.

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Abstract

The invention discloses a traditional Chinese medicine composition for treating phlegm stagnation type pulmonary nodules and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials: 3-10 parts of pericarpium citri reticulatae, 3-10 parts of rhizoma pinellinae praeparata, 10-15 parts of poria cocos, 5-10 parts of peach kernels, 8-15 parts of quartz, 8-15 parts of cowherb seeds, 15-30 parts of radix ranunculi ternati, 6-10 parts of curcuma zedoary, 10-30 parts of coix seeds, 10-30 parts of sculellaria barbata and 2-10 parts of liquorice. The traditional Chinese medicine composition can be used for treating phlegm stagnation type pulmonary nodule, has the characteristics of treating both symptoms and root causes, high efficiency, good effect and low cost, and is convenient to use and good in patient compliance.
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Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules and a preparation method thereof. Background Art

[0002] Pulmonary nodules refer to focal, round-shaped, solid or subsolid lung shadows with a diameter of ≤3 cm in the lungs that are surrounded by lung parenchyma and found by imaging examinations. They may be solitary or multiple, without atelectasis, hilar lymphadenopathy, or pleural effusion. Phlegm-stasis-blocking lung nodules are mostly asymptomatic, with only ground-glass or mixed ground-glass high-density shadows appearing on CT.

[0003] Lung nodules belong to the category of "lung accumulation" in traditional Chinese medicine. They are mostly caused by the invasion of six evil haze toxins or lung qi deficiency. The basic pathogenesis is "qi stagnation, dampness obstruction, phlegm and blood stasis stagnation". The lung is the canopy of the five internal organs. It controls qi and breathing, treats the meridians and regulates the body, and controls the qi mechanism to spread and descend and help the water flow. The lung is a delicate organ, and the lung qi is connected to the sky. People are born with qi from nature and communicate with the air in nature through the mouth and nose. External evil haze toxins can easily damage the lungs and cause lung qi deficiency. The damage to the lung qi mechanism is the first to be affected, which can cause water and dampness stagnation, and then cause phlegm turbidity and blood stasis to stagnate and cause lung accumulation. Over time, the toxicity can evolve into lung cancer. Either the lung qi is congenitally insufficient or acquired malnutrition, and the invasion of six evil haze toxins consumes the lung qi, which reduces the lung's ability to resist evil and causes dysfunction, abnormal distribution of qi, blood and body fluids, and phlegm turbidity and blood stasis eventually lead to lung accumulation. Therefore, qi stagnation, dampness obstruction, phlegm and blood stasis are the basic pathogenesis of lung accumulation, and phlegm and blood stasis obstruction is the key pathogenesis of lung accumulation.

[0004] Pulmonary sarcoidosis is a highly coordinated immune response involving sequential antigen-driven CD4 + T cell activation, chemokine-driven accumulation of activated T cells in the lungs, local macrophage accumulation and granuloma formation. The characteristic pathological changes are non-caseating epithelioid cell granulomas, which are mainly composed of well-differentiated mononuclear phagocytes (epithelioid cells and giant cells) and lymphocytes. A typical feature of active sarcoidosis is that the affected organs mainly express interferon-γ (IFN-γ), as well as other important cytokines such as interleukin 2 (IL-2), IL-12 and tumor necrosis factor-α (TNF-α). Typical non-caseating granulomas are sterile, and the center of the granuloma is mainly CD4 + T cells, while peripheral cells are mainly CD8 + T cells. Sarcoid granulomas either dissipate or develop into fibrosis, and are mainly distributed along the lymphatic channels in the lungs. The pathogenesis of pulmonary sarcoidosis is very complex and is not yet clear. It includes other unknown mechanisms such as innate immune response, T cell action, and the effect of Th17 cells on IFN-γ release in adaptive immune response.

[0005] There are many methods for treating lung nodules, including lifestyle adjustments, drug therapy, surgical resection and other treatment methods. Among them, lifestyle adjustments have the disadvantages of slow effect and long time consumption. Drug therapy is the most commonly used in clinical practice. Commonly used therapeutic drugs include: glucocorticoids and immunosuppressants, but they are often accompanied by some side effects. Surgical resection is the first treatment option for high-risk lung nodules, and is not suitable for the treatment of medium- and low-risk lung nodules.

[0006] Therefore, studying treatment options for phlegm and blood stasis type lung nodules that have significant clinical efficacy, few side effects and are appropriate has become an important direction for current medical workers to work on. Summary of the invention

[0007] In view of the above situation, it is necessary to provide a Chinese medicine composition for treating phlegm and blood stasis type pulmonary nodules and a preparation method thereof.

[0008] The invention provides a traditional Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules. The traditional Chinese medicine composition is prepared from the following raw materials by weight: 3-10 parts of dried tangerine peel, 3-10 parts of French pinellia, 10-15 parts of tuckahoe, 5-10 parts of peach kernel, 8-15 parts of quartz, 8-15 parts of fenugreek, 15-30 parts of cat's claw, 6-10 parts of zedoaria, 10-30 parts of coix seeds, 10-30 parts of barbata scutellaria and 2-10 parts of liquorice.

[0009] In the present invention, the Pinellia tuber has a pungent and warm taste, and is in the spleen, stomach, and lung meridians; it can dry dampness and resolve phlegm, reduce adverse reactions and stop vomiting, and eliminate lumps and resolve lumps. Various processed products have obvious antitussive effects, which are similar to codeine but weaker in effect, and have a certain expectorant effect. It can inhibit the vomiting center and exert an antiemetic effect, and can significantly inhibit gastric juice secretion. Its water decoction and alcohol precipitation have significant preventive and therapeutic effects on gastric ulcers caused by multiple reasons. It can increase the activity of tyrosine aminotransferase in the liver and also promote bile secretion. Its diluted alcohol, water extract or its polysaccharide components and alkaloids have a wide range of anti-tumor effects.

[0010] Tangerine peel tastes bitter, pungent, warm, and enters the spleen and lung meridians; it can regulate qi and strengthen the spleen, dry dampness and resolve phlegm. Tangerine peel decoction has a significant promoting effect on salivary amylase activity, can inhibit the spontaneous activity of isolated rabbit duodenum, reduce contraction, and reduce tension; it has a direct inhibitory effect on isolated and intestinal gastric and intestinal motility.

[0011] Poria cocos tastes sweet, light and flat, and it enters the heart, lung, spleen and kidney meridians; it can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind and nerves. Poria cocos decoction, syrup, alcohol extract and ether extract have the effects of diuresis, sedation, anti-tumor and increasing myocardial contractility. The polysaccharides contained in Poria cocos have the effect of enhancing immune function.

[0012] Peach kernel tastes bitter, sweet and flat, and enters the heart, liver and large intestine meridians; peach kernel decoction and extract have analgesic, anti-inflammatory, antibacterial, antitussive and anti-asthmatic effects and anti-liver fibrosis effects.

[0013] Vaccariae is bitter and flat in taste, and enters the liver and stomach meridians; it can promote blood circulation and menstruation, promote lactation and reduce swelling, and promote diuresis and relieve stranguria. Both the water extract and ether extract of Vaccariae have anti-tumor effects.

[0014] Cat's claw is sweet, spicy, warm, and enters the liver and lung meridians; it can resolve phlegm and resolve nodules, detoxify and reduce swelling. The aqueous extract of this product has inhibitory effects on Staphylococcus aureus, Staphylococcus albus, Shigella dysenteriae, etc., and can inhibit drug-resistant tuberculosis. In addition, it has antitussive, expectorant, anti-tumor, and immune-enhancing effects.

[0015] Coix seeds are sweet, light and cool. They enter the spleen, stomach and lung meridians; they can promote diuresis and eliminate dampness, strengthen the spleen and stop diarrhea, eliminate numbness, discharge pus, detoxify and disperse nodules. The alcohol and acetone extracts in coix seeds have a significant inhibitory effect on cancer cells. And its fatty oil can reduce serum calcium and blood sugar levels, and has antipyretic, sedative, analgesic, and immune-regulating effects.

[0016] Scutellaria barbata tastes pungent, bitter, and cold, and enters the lung, liver, and kidney meridians; it can clear away heat and detoxify, remove blood stasis and promote diuresis. It is suitable for treating carbuncle, sore throat, pain from falls, edema, jaundice, snake and insect bites, etc.

[0017] Curcuma zedoaria is pungent, bitter, warm, and enters the liver and spleen meridians; it can break blood and promote qi, eliminate accumulation and relieve pain. Curcuma zedoaria volatile oil preparations have anti-cancer effects and can inhibit the growth of various pathogenic bacteria; Curcuma zedoaria oil has anti-inflammatory, anti-gastric ulcer, and liver protection effects. Curcuma zedoaria water extract can inhibit platelet aggregation, promote the recovery of arteriolar blood flow, and promote the recovery of local microcirculation; Curcuma zedoaria water extract alcohol precipitation has an inhibitory effect on thrombosis in the body. In addition, Curcuma zedoaria has a direct inactivation effect on respiratory syncytial virus.

[0018] Quartz tastes sweet and warm. It is good for the lungs, kidneys and heart. It can warm the lungs and kidneys, calm the mind and promote urination. Silicon (Si) absorbed by the human body not only has special therapeutic effects on heart disease and cancer, but also maintains the elasticity of blood vessel walls to prevent hardening.

[0019] Licorice is sweet and flat in taste, and it enters the heart, lung, spleen, and stomach meridians; it can nourish the spleen and replenish qi, clear away heat and detoxify, relieve phlegm and cough, relieve acute pain, and harmonize various medicines. Glycyrrhizic acid and flavonoids are the two main active ingredients of licorice. Glycyrrhizic acid and flavonoids have antitussive, expectorant, and antiasthmatic effects. In addition, glycyrrhizic acid and flavonoids also have antiarrhythmic, reduce intestinal tension, reduce contraction amplitude, and relieve spasm.

[0020] The Chinese medicine composition of the present invention comprises pinellia tuber and peach kernel as the main drugs, dried orange peel and radix cyperi as the assistant drugs, tuckahoe, quartz, cat's claw, zedoaria, coix seed and scutellaria barbata as the auxiliary drugs, and liquorice as the guiding drug. The raw materials used in the Chinese medicine composition are matched according to their effects and have a synergistic effect.

[0021] Banxia is good at drying dampness and resolving phlegm to treat damp phlegm in the internal organs, and it can also eliminate lumps and resolve knots, and enter the lung, stomach, and spleen meridians; peach kernel has the effects of promoting blood circulation and removing blood stasis, relieving cough and relieving asthma, and enters the heart, liver, lung, and large intestine meridians. The combination of the two can achieve the effect of resolving phlegm, promoting blood circulation and resolving knots. Tangerine peel can regulate qi and relieve stagnation, dry dampness and resolve phlegm, so as to enhance the function of drying dampness and resolving phlegm. At the same time, when qi moves, dampness is difficult to gather, and the source of phlegm is eliminated; Vaccaria can promote blood circulation, dredge meridians and eliminate carbuncle, enter the blood, and is good at unblocking blood vessels, which can enhance the function of promoting blood circulation, unblocking collaterals and resolving knots. The two medicines are ministers to help the monarch to strengthen the power of phlegm, promoting blood circulation and resolving knots.

[0022] Poria strengthens the spleen and eliminates dampness, and when paired with dried tangerine peel, it can eliminate the source of phlegm. Quartz, cat's claw, zedoaria, coix seed, and Scutellaria barbata can be used together to disperse nodules and dissolve blood stasis. Among them, zedoaria can also break up qi and has a strong power to move qi. As the saying goes, when qi moves, body fluid moves, and when qi moves, blood moves. When qi is regulated, blood vessels are unobstructed. When qi and blood vessels are regulated, phlegm and blood stasis are difficult to cause trouble. Licorice harmonizes all the medicines and is a guiding medicine.

[0023] The invention focuses on dissolving phlegm, blood stasis and nodules, regulating qi and blood, and uses the herbs such as Pinellia ternata and dried orange peel to dry dampness and resolve phlegm in the formula, and adds Poria cocos and licorice to strengthen the spleen, while preventing the regeneration of phlegm and dampness; uses the herbs such as peach kernel, Vaccaria segetalis, quartz to dredge meridians, dissolve blood stasis and resolve nodules, and adds the effect of Curcuma zedoaria to break up qi and resolve nodules, so that qi stagnation is removed and blood vessels are harmonized, and the phlegm and blood stasis obstruction type lung accumulation is treated together. Therefore, the various medicines in the prescription play the effects of dissolving phlegm, activating blood circulation, promoting qi and resolving nodules, and are mainly used to treat phlegm and blood stasis obstruction type lung nodules.

[0024] The Chinese medicine composition of the present invention is novel and unique in formula, and is used for treating pulmonary nodules of phlegm and blood stasis type, and has the characteristics of treating both the symptoms and the root causes, having few side effects, high efficiency, good effect, and low cost, and is convenient to use and has good patient compliance. At the same time, it also has a significant therapeutic effect on pulmonary nodules of phlegm and blood stasis type that turns into heat and toxicity over a long period of time.

[0025] Furthermore, the above-mentioned Chinese medicine composition is made of the following raw materials, by weight: 10 parts of tangerine peel, 10 parts of French pinellia, 15 parts of Poria, 10 parts of peach kernel, 15 parts of quartz, 15 parts of fenugreek, 20 parts of cat's claw, 10 parts of Curcuma, 30 parts of coix seed, 10 parts of Scutellaria barbata, and 6 parts of licorice.

[0026] Furthermore, in the above-mentioned Chinese medicine composition, among its raw materials, the amount of the drug for dispersing nodules is greater than the amount of the drug for resolving phlegm and unblocking meridians in the prescription.

[0027] Furthermore, in the above-mentioned Chinese medicine composition, the coix seed is raw coix seed.

[0028] Furthermore, the above-mentioned Chinese medicine composition also contains pharmaceutically acceptable excipients and is made into decoction, granules, capsules or pills.

[0029] The present invention also discloses a method for preparing the Chinese medicine composition as described in any one of the above, comprising: Weigh each raw material according to the ratio; The fine powder of the raw material or the water extract of the raw material is used as the active ingredient, and pharmaceutically acceptable auxiliary materials are added to prepare decoction, granules, capsules or pills.

[0030] Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention. DETAILED DESCRIPTION

[0031] In order to make the purpose, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the examples. Several embodiments of the present invention are given in the examples. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.

[0032] Example 1 A Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules, comprising the following raw materials: 10g of French Pinellia, 10g of dried tangerine peel, 15g of Poria, 10g of peach kernel, 15g of quartz, 15g of Vaccaria, 20g of Cat's Claw, 10g of Curcuma, 30g of Coix seed, 10g of Scutellaria barbata, and 6g of Licorice.

[0033] Soak the medicine in water for half an hour, then boil it for 30 to 40 minutes, collect and extract it, and then take it orally.

[0034] Example 2 A Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules, comprising the following raw materials: 10g of French Pinellia, 10g of dried tangerine peel, 15g of Poria, 10g of peach kernel, 15g of quartz, 15g of Vaccaria, 20g of Cat's Claw, 10g of Curcuma, 30g of Coix seed, 10g of Scutellaria barbata, and 6g of Licorice.

[0035] The above raw materials are processed into granules after being boiled, concentrated, dried and other processes.

[0036] Example 3 A Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules, comprising the following raw materials: 5g of French Pinellia, 4g of Tangerine Peel, 10g of Poria, 8g of Peach Kernel, 10g of Quartz, 12g of Vaccaria, 15g of Cat's Claw, 10g of Curcuma, 20g of Coix Seed, 10g of Scutellaria Scutellariae, and 2g of Licorice.

[0037] Soak the medicine in water for half an hour, then boil it for 30 to 40 minutes, collect and extract it, and then take it orally.

[0038] Example 4 A Chinese medicine composition for treating phlegm and blood stasis obstruction type pulmonary nodules, comprising the following raw materials: 3g of Pinellia ternata, 3g of dried tangerine peel, 12g of Poria cocos, 5g of peach kernel, 8g of quartz, 8g of Vaccaria segetalis, 30g of Cat's Claw, 6g of Curcuma zedoaria, 10g of Coix seed, 30g of Scutellaria barbata, and 10g of Licorice.

[0039] Soak the medicine in water for half an hour, then boil it for 30 to 40 minutes, collect and extract it, and then take it orally.

[0040] The experimental protocol is as follows.

[0041] 1. General Information Fifty patients with phlegm-stasis obstruction type pulmonary nodules who met the criteria were selected and divided into two groups according to the random number table method, 25 cases in the treatment group and 25 cases in the control group. The two groups were comparable in age, gender, and course of disease.

[0042] 2. Diagnostic criteria Referring to the 2018 Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules: The imaging manifestations are focal, round, increased density, solid or subsolid lung shadows with a diameter of ≤3 cm, which may be solitary or multiple, without atelectasis, hilar lymphadenopathy, and pleural effusion.

[0043] 3. Inclusion criteria: (1) Meet the diagnostic criteria for pulmonary nodules, diameter ≤ 1 cm; (2) The characteristics of the nodules on chest CT are solid nodules or pure ground glass nodules; (3) The syndrome is diagnosed as phlegm and blood stasis according to TCM diagnosis; (4) Aged between 18 and 80 years old; (5) Voluntarily seek treatment with traditional Chinese medicine.

[0044] 4. Exclusion criteria (1) Diffuse nodules (≥10); (2) Patients whose disease has seriously affected their daily life or who have other diseases with obvious symptoms; (3) Patients with serious diseases of the heart, liver, kidney and hematopoietic system; (4) Pregnant women, breastfeeding women, and patients with mental illness; (5) Those who are allergic to the study drugs.

[0045] 5. Elimination criteria (1) Those who fail to take Chinese medicine as required due to various reasons; (2) Those who take other Chinese or Western medicines during medication; (3) Subjects whose other diseases significantly affect the efficacy and safety of medication during medication; 6. Termination criteria (1) Serious adverse events occurred during the intervention period; (2) Complications and special physiological changes; 7. Treatment methods Treatment group: conventional treatment (psychological counseling, health education, advising patients to eat a balanced and nutritious diet, quit smoking, and stay away from harmful environments such as secondhand smoke) combined with Chinese medicine treatment, using the Chinese medicine composition in Example 1, with 2 months as one course of treatment. After one course of treatment, chest CT was reviewed 6 months later.

[0046] Control group: conventional treatment (psychological counseling, health education, advising patients to eat a balanced and nutritious diet, quit smoking, and stay away from harmful environments such as secondhand smoke).

[0047] 8. Efficacy indicators According to the diagnostic criteria and classification of lung nodules, efficacy determination criteria were formulated based on the patient's chest CT imaging changes.

[0048] (1) Based on the changes in lung nodule volume before and after treatment in the two groups, the efficacy evaluation criteria are shown in Table 1.

[0049] Table 1

[0050] (2) Evaluation of the efficacy of malignant risk scores of pulmonary nodules before and after treatment in the two groups The Mayo model prediction formula was used to calculate the change in nodule malignancy risk score before and after treatment. Multiple nodules were graded according to the nodule with the highest risk. The calculation formula is as follows: Probability of malignancy ( P )=e x / (1+e x ), X = -6.8272 + (0.0391 × age) + (0.7917 × smoking history) + (1.3388 × history of malignant tumor) + (0.1274 × diameter) + (1.0407 × burrs) + (0.7838 × upper lobe); e is the natural coefficient; age is in years; diameter is in mm; smoking history is counted as 1, no history is counted as 0; burrs are counted as 1, no history is counted as 0; located in the upper lobe of the lung is counted as 1, and others are counted as 0.

[0051] (3) The TCM syndrome efficacy evaluation of symptoms and signs of patients with lung nodules in the two groups before and after treatment is shown in Table 2.

[0052] Table 2

[0053] 9. Statistical analysis After the basic information, relevant information and various data of the subjects were collected and collated and proofread, SPSS26.0 statistical software was used for data collation and analysis. The paired sample t test was used for comparison within the two groups, and the two independent sample t test was used for comparison between the two groups. The count data were expressed as frequency (percentage), and the chi-square test was used for comparison between the two groups. P<0.05 was considered statistically significant.

[0054] Experimental Results (1) Comparison of general data between the two groups The chi-square test and two independent sample t-tests showed that there was no statistically significant difference in gender, disease course and age between the two groups (P>0.05). Tables 3, 4 and 5 below show the comparison of general data between the two groups.

[0055] Table 3. Cases included

[0056] Table 4 Comparison of gender of included cases

[0057] Table 5 Age of included cases

[0058] (2) Comparison of lung nodule data between the two groups of patients before treatment. The comparison of lung nodule size is shown in Table 6, and the comparison of lung nodule location and density is shown in Table 7.

[0059] Table 6 Comparison of lung nodule volume between the two groups before treatment

[0060] There were more patients with multiple pulmonary nodules, with the ratio of multiple pulmonary nodules to solitary pulmonary nodules being approximately 2.84:1; there were more patients in the right lung than in the left lung, and the right upper lobe was the largest in the right lung, accounting for approximately 50% of the right lung; there were more patients with ground-glass nodules than with solid nodules, accounting for approximately 61.7% of the total number, as shown in Table 7 for details.

[0061] Table 7 Comparison of location and density of pulmonary nodules between the two groups of patients before treatment

[0062] The comparison results of the maximum diameter of lung nodules in the two groups of patients before and after treatment are shown in Tables 8 and 9.

[0063] Table 8 Comparison of the maximum diameter of lung nodules in the treatment groups (before and after treatment)

[0064] Table 9 Comparison of the maximum diameter of lung nodules in the control group (before and after treatment)

[0065] Note: Compared with before treatment, P < 0.05.

[0066] (3) Comparison of clinical efficacy of pulmonary nodule malignancy risk scores before and after treatment between the two groups After one month of treatment, the cure rate and effective rate of the treatment group were higher than those of the control group (P < 0.05), as shown in Table 10.

[0067] Table 10 Comparison of malignancy risk scores within the group before and after treatment

[0068] The clinical efficacy evaluation of TCM syndromes in the two groups of patients before and after treatment of pulmonary nodules is shown in Table 11 (n (%)).

[0069] Table 11 Comparison of TCM syndrome scores within the same group before and after treatment

[0070] (4) Safety evaluation During the trial, the two groups of patients underwent routine blood, urine, and stool tests before and after treatment, as well as liver and kidney function and electrocardiogram tests to evaluate the safety of the drug. Results: No results were found that were normal before treatment and abnormal after treatment, indicating that the prescription is safe.

[0071] Typical clinical cases Case 1: A 59-year-old male patient was diagnosed with multiple nodules in both lungs for 9 days during a physical examination at the hospital. The larger one was located in the dorsal segment of the left lower lobe of the lung, showing a solid density of about 7*4mm in size. The trachea and bronchus were unobstructed, and no clear enlarged lymph nodes were found in the hilum of both lungs and the mediastinum. The patient had no obvious discomfort when he visited the hospital, and his mental appetite was good, his bowel movements were normal, and his sleep was good. Diagnosis: pulmonary sarcoidosis, the Chinese medicine decoction of Example 1 was given for two months, and a chest CT scan was performed six months later, showing: rough textures in both lungs, multiple micro- and small nodules in both lungs, the larger one was located in the dorsal segment of the left lower lobe of the lung, showing a solid density of about 5*3mm in size. No increase was observed after a follow-up visit six months later.

[0072] Case 2: Patient female, 61 years old, the patient suspected of catching a cold and coughing a week ago, the intravenous anti-inflammatory effect of the local clinic was not good, and the cough was slightly relieved by taking Fenghan Ganmao Granules and Xuanfei Zhisou Mixture on her own. The chest CT scan of the previous hospital showed: multiple micro-nodules in both lungs, the larger one was located in the outer segment of the right middle lobe of the lung, with a solid density of about 6*4mm, and an average CT value of about -354.6HU. Symptoms during the visit: cough, coughing when itchy throat, day and night, white and sticky sputum, no dry mouth and bitter mouth, no chest tightness and asthma, general spirit, and the rest of the situation can be diagnosed as cough and pulmonary sarcoidosis. I took the Chinese medicine decoction of embodiment 1 for two months, and the chest CT was checked after two months: the texture of both lungs was rough and chaotic, and multiple micro-nodules in both lungs were seen, the larger one was located in the outer segment of the right middle lobe of the lung, with a solid density of about 4*2mm. Follow-up after 6 months did not increase.

[0073] Case 3: A 49-year-old male patient had repeated coughs for more than 2 years, which worsened for 4 days. The patient developed coughs due to smoking 4 years ago, but did not pay attention to them. 4 days ago, the cough worsened, accompanied by sputum. He then underwent chest CT in the hospital, which showed: coarsening of the texture of both lungs, scattered patches, cords, and strips of increased density in both lungs, and some unclear boundaries; a few small nodules were seen in the upper lobes of both lungs, with clear boundaries and no calcification, and the larger ones were about 4mm in diameter. The trachea and bronchus were unobstructed, and no obvious enlarged lymph nodes were found in the hilum of both lungs and the mediastinum. Symptoms during outpatient visits: cough, coughing with sputum, liking to clear the throat, white and sticky sputum, itchy throat, no chest tightness and shortness of breath, easy fatigue, fatigue aggravated after activity, weak spirit, normal appetite, normal bowel movements, poor sleep, pale tongue with white greasy coating, and stringy and slippery pulse; diagnosis: cough, pulmonary sarcoidosis. The patient was given the Chinese medicine decoction of Example 1 for two months, and a chest CT scan was performed 6 months later, showing: increased texture in both lungs, a few solid nodules in the right lung, clear boundaries, and a diameter of about 3 mm, unobstructed trachea and bronchus, and no clear enlarged lymph nodes in both hilum and mediastinum.

[0074] According to the experimental results, any one of the Chinese medicine compositions in Examples 2 to 4 of the present invention was used to carry out the above experiment, and all of them had the efficacy of treating phlegm and blood stasis type lung nodules.

[0075] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0076] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A Chinese medicine composition for treating phlegm and blood stasis type pulmonary nodules, characterized in that: The invention is made of the following raw materials by weight: 3-10 parts of dried tangerine peel, 3-10 parts of French pinellia, 10-15 parts of poria, 5-10 parts of peach kernel, 8-15 parts of quartz, 8-15 parts of fenugreek, 15-30 parts of cat's claw, 6-10 parts of zedoaria, 10-30 parts of coix seed, 10-30 parts of barbata, and 2-10 parts of licorice.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is made from the following raw materials by weight: 10 parts of dried tangerine peel, 10 parts of French pinellia, 15 parts of tuckahoe, 10 parts of peach kernel, 15 parts of quartz, 15 parts of fenugreek, 20 parts of cat's claw, 10 parts of zedoaria, 30 parts of coix seed, 10 parts of barbata scabra, and 6 parts of licorice.

3. The Chinese medicine composition according to claim 1, characterized in that: The coix seeds are raw coix seeds.

4. The Chinese medicine composition according to claim 1, characterized in that: The invention also contains pharmaceutically acceptable auxiliary materials and is prepared into decoction, granules, capsules or pills.

5. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: include: Weigh each raw material according to the ratio; The fine powder of the raw material or the water extract of the raw material is used as the active ingredient, and pharmaceutically acceptable auxiliary materials are added to prepare decoction, granules, capsules or pills.

Citation Information

Patent Citations

  • Medicine composition and application thereof in preparation of medicine for treating lung cancer

    CN111067995A

  • Oral liquid for relieving chest stuffiness and regulating qi

    CN112546194A

  • Composition for treating pulmonary nodules and preparation method thereof

    CN113197992A

  • Pharmaceutical composition for treating pulmonary nodule as well as preparation and application thereof

    CN115252748A

  • Traditional Chinese medicine composition for treating phlegm-blood stasis type pulmonary nodule, preparation method and application thereof

    CN115381914A