A traditional Chinese medicine composition for resolving phlegm, promoting blood circulation and removing blood stasis and a preparation method and application of a decoction thereof

Abstract

The application provides a kind of traditional Chinese medicine composition of resolving phlegm and promoting blood circulation and removing stasis and preparation method and application of its decoction, the traditional Chinese medicine composition of resolving phlegm and promoting blood circulation and removing stasis includes the following components by weight fraction: turtle shell 10-30 parts, oyster 10-30 parts, Huangqi 1-5 parts, Fahanxia 1-10 parts, Renshen 1-10 parts, Baichizi 1-10 parts, Zhebeimu 1-10 parts, Maozhaocao 1-10 parts, Zaokesheng 1-10 parts, Eshu 1-10 parts, Jinqiaomei 1-10 parts and Zhigancao 1-10 parts.The traditional Chinese medicine composition of resolving phlegm and promoting blood circulation and removing stasis provided by the application has good treatment effect, small side effect and high safety, and its decoction has the effects of resolving phlegm and promoting blood circulation, removing stasis and eliminating stasis, benefiting qi and strengthening body resistance, is mainly used for treating phlegm and blood stasis blocking lung type lung nodule, can be used as long-term treatment drug for lung nodule ≤8mm, can also be used for the adjuvant therapy of lung nodule 8-30mm, is suitable for and relieves the symptoms of phlegm and blood stasis blocking lung type lung nodule with cough, expectoration, chest distress and lassitude.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for resolving phlegm, promoting blood circulation and dispersing nodules, and its preparation method and application in decoction. Background Technology

[0002] The incidence of pulmonary nodules is rising year by year, and their pathogenesis remains unclear, resulting in very limited treatment options. How to intervene in pulmonary nodules has become a current hot topic and a challenge. Pulmonary nodules have various causes, such as developmental abnormalities, infections, inflammation, old lesions, and tumors. Western medicine often focuses on follow-up for pulmonary nodules that do not meet surgical indications, with limited treatment options. Patients often do not receive effective treatment, leading to significant psychological stress and a vicious cycle. At this point, Traditional Chinese Medicine (TCM) can fully leverage its advantages, offering multi-target, multi-pathway, and multi-stage treatment for pulmonary nodules. TCM believes that the pathogenesis of pulmonary nodules involves the interplay of "deficiency," "phlegm," "blood stasis," and "toxins," obstructing the flow of Qi. Currently, document CN115381914A, "A Chinese medicine composition for treating pulmonary nodules of phlegm-blood stasis type, preparation method and application", and document CN114699502B, "A Chinese medicine composition for dispersing nodules, resolving phlegm and promoting blood circulation, preparation method and application", disclose phlegm-resolving Chinese medicine compositions. However, both of them have the drawbacks of having many components and relatively poor efficacy. Summary of the Invention

[0003] In order to solve the above-mentioned technical problems, one of the objectives of this invention is to provide a traditional Chinese medicine composition that combines tonifying the body's resistance with eliminating pathogenic factors, which can not only improve the clinical efficacy of pulmonary nodules, but also maintain or reduce the size of benign pulmonary nodules to a certain extent, and can also treat pulmonary nodules of the phlegm-stasis obstructing the lungs.

[0004] To achieve the above objectives, the technical solution of the present invention is as follows: a traditional Chinese medicine composition for resolving phlegm, promoting blood circulation, and dispersing nodules, comprising the following components by weight: 10-30 parts of turtle shell, 10-30 parts of oyster shell, 1-5 parts of scutellaria baicalensis, 1-10 parts of prepared pinellia ternata, 1-10 parts of ginseng, 1-10 parts of white mustard seed, 1-10 parts of fritillaria thunbergii, 1-10 parts of cat's claw herb, 1-10 parts of gleditsia sinensis thorn, 1-10 parts of turmeric, 1-10 parts of buckwheat, and 1-10 parts of prepared licorice root.

[0005] Preferably, the ingredients include the following components by weight: 20 parts turtle shell, 20 parts oyster shell, 5 parts scutellaria baicalensis, 5-10 parts prepared pinellia ternata, 5 parts ginseng, 5-10 parts white mustard seed, 5-10 parts Zhejiang fritillary bulb, 5-10 parts cat's claw herb, 5-10 parts soapberry thorn, 5-10 parts turmeric, 5-10 parts buckwheat, and 5 parts prepared licorice root.

[0006] Further preferred, by weight, it includes the following components: 20 parts turtle shell, 20 parts oyster shell, 5 parts Scutellaria baicalensis, 5 or 10 parts prepared Pinellia ternata, 5 or 10 parts ginseng, 5 or 10 parts white mustard seed, 5 or 10 parts Fritillaria thunbergii, 5 or 10 parts Uncaria rhynchophylla, 5 or 10 parts Gleditsia sinensis thorn, 5 or 10 parts Curcuma zedoaria, 5 or 10 parts Fagopyrum dibotrys, and 5 parts prepared licorice root.

[0007] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine decoction for resolving phlegm, promoting blood circulation, and dispersing nodules.

[0008] To achieve the above objectives, the technical solution of the present invention is as follows: a method for preparing a traditional Chinese medicine decoction for resolving phlegm, promoting blood circulation and dispersing nodules, wherein the preparation method involves adding water to the above-mentioned traditional Chinese medicine composition for resolving phlegm, promoting blood circulation and dispersing nodules and decocting it, filtering the filtrate, and then concentrating the filtrate to obtain the traditional Chinese medicine decoction for resolving phlegm, promoting blood circulation and dispersing nodules.

[0009] The specific decoction process of the phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine composition is as follows: after decocting the turtle shell and oyster shell in the phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine composition with water for 20-40 minutes, add Scutellaria baicalensis, Pinellia ternata, ginseng, white mustard seed, Fritillaria thunbergii, Uncaria rhynchophylla, Gleditsia sinensis thorn, Curcuma zedoaria, Fagopyrum dibotrys and Glycyrrhiza uralensis and continue to decoct for 20-40 minutes.

[0010] The filtrate is concentrated to a concentration of 0.3-0.4 g / mL, calculated according to the traditional Chinese medicine composition for resolving phlegm, promoting blood circulation, and dispersing nodules.

[0011] The concentration method mentioned above involves heating for concentration.

[0012] The third objective of this invention is to provide a traditional Chinese medicine decoction for resolving phlegm, promoting blood circulation, and dispersing nodules, prepared using the method described above.

[0013] The fourth objective of this invention is to provide the application of the above-mentioned phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine composition or the above-mentioned phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine decoction in the preparation of drugs for treating pulmonary nodules of the phlegm-blood stasis obstructing the lungs.

[0014] The beneficial effects of this invention are as follows: the traditional Chinese medicine composition for resolving phlegm, promoting blood circulation, and dispersing nodules provided by this invention has good therapeutic effect, few side effects, and high safety. Its decoction has the effects of resolving phlegm, promoting blood circulation, dispersing nodules and eliminating masses, and invigorating qi and strengthening the body. It is mainly used to treat pulmonary nodules of the phlegm-blood stasis type. It can be used as a long-term treatment drug for pulmonary nodules ≤8mm. It can also be used as an adjunct treatment for pulmonary nodules of 8-30mm. It is suitable for and relieves the symptoms of pulmonary nodules of the phlegm-blood stasis type that patients have at the same time have cough, sputum, chest tightness, and fatigue. Detailed Implementation

[0015] The principles and features of the present invention are described below with reference to embodiments. The examples given are for illustrative purposes only and are not intended to limit the scope of the invention. The advantages and features of the present invention will become clearer from the following description and claims.

[0016] This embodiment provides a traditional Chinese medicine composition for resolving phlegm, promoting blood circulation, and dispersing nodules. Its characteristic is that, by weight, it comprises the following components: 10-30 parts of turtle shell (which can be any value or a range between any two values ​​from 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 parts); and 10-30 parts of oyster shell (which can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 parts). The range of any two values ​​(1, 22, 23, 24, 25, 26, 27, 28, 29, or 30 parts) is provided. Other options include: Scutellaria baicalensis (1-5 parts, which can be any two values ​​(1, 2, 3, 4, or 5 parts)); Pinellia ternata (1-10 parts, which can be any two values ​​(1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts)); and Panax ginseng (1-10 parts, which can be any two values ​​(1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts) are provided. The range includes: white mustard seed 1-10 parts (any value or any two values ​​from 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts); Zhejiang fritillary bulb 1-10 parts (any value or any two values ​​from 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts); cat's claw herb 1-10 parts (any value or any two values ​​from 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts); and soapberry thorn 1-10 parts (any value or any two values ​​from 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts). The range of any two values, including 6, 7, 8, 9, or 10 parts, is as follows: Curcuma zedoaria 1-10 parts (which can be any two values, including 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts), Buckwheat 1-10 parts (which can be any two values, including 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts), and Prepared Licorice Root 1-10 parts (which can be any two values, including 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts).

[0017] Preferably, the ingredients include the following components by weight: 20 parts turtle shell, 20 parts oyster shell, 5 parts scutellaria baicalensis, 5 or 10 parts prepared pinellia ternata, 5 or 10 parts ginseng, 5 or 10 parts white mustard seed, 5 or 10 parts Zhejiang fritillary bulb, 5 or 10 parts cat's claw herb, 5 or 10 parts soapberry thorn, 5 or 10 parts turmeric, 5 or 10 parts buckwheat, and 5 parts prepared licorice root.

[0018] This embodiment also provides a method for preparing the decoction corresponding to the above-mentioned phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine composition. The specific preparation method is as follows: Boil turtle shell and oyster shell in water for 20-40 minutes (this can be any value or a range between any two values ​​from 20 min, 21 min, 22 min, 23 min, 24 min, 25 min, 26 min, 27 min, 28 min, 29 min, 30 min, 31 min, 32 min, 33 min, 34 min, 35 min, 36 min, 37 min, 38 min, 39 min, and 40 minutes), then add Scutellaria baicalensis, Pinellia ternata, and human... Continue to decoct ginseng, white mustard seed, fritillaria thunbergii, cat's claw grass, soapberry thorn, turmeric, buckwheat and prepared licorice for 20-40 minutes (any value or range between any two values ​​from 20 min, 21 min, 22 min, 23 min, 24 min, 25 min, 26 min, 27 min, 28 min, 29 min, 30 min, 31 min, 32 min, 33 min, 34 min, 35 min, 36 min, 37 min, 38 min, 39 min and 40 min), then filter the filtrate, and then heat and concentrate the filtrate to obtain the phlegm-resolving, blood-activating and nodule-dispersing traditional Chinese medicine decoction. The mass-to-volume ratio of the phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine composition to water is at least 0.5 g / mL (of course, more water is not necessarily better; it is best not to exceed 1.5 g / mL, and can be any value or a range between any two values ​​from 0.5 g / mL, 0.6 g / mL, 0.7 g / mL, 0.8 g / mL, 0.9 g / mL, 1 g / mL, 1.1 g / mL, 1.2 g / mL, 1.3 g / mL, 1.4 g / mL, and 1.5 g / mL); the filtrate is concentrated to a value of 0. 3-0.4g / mL (specifically, it can be any value or any two of 0.3g / mL, 0.31g / mL, 0.32g / mL, 0.33g / mL, 0.34g / mL, 0.35g / mL, 0.36g / mL, 0.37g / mL, 0.38g / mL, 0.39g / mL, and 0.4g / mL), which can be understood as the amount of water added to 100g of the phlegm-resolving, blood-activating, and nodule-dispersing traditional Chinese medicine composition being at least 500mL and at most 1500mL, while the concentrated medicinal liquid after steaming and boiling can be 300-400mL.

[0019] Mechanism analysis of the drug raw materials in this embodiment:

[0020] Turtle shell: Salty, slightly cold. Enters the liver and kidney meridians.

Functions and Indications

[0021] Oyster: Salty, slightly cold. Enters the liver, gallbladder, and kidney meridians.

Functions and Indications

[0022] Scutellaria baicalensis: Bitter, cold. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians.

Functions and Indications

[0023] Pinellia ternata (processed): pungent, warm. Enters the spleen, stomach, and lung meridians.

Functions and Indications

[0024] Ginseng: Sweet, slightly bitter, neutral. Enters the spleen, lung, and heart meridians.

Functions and Indications

[0025] White mustard seed: pungent; warm. Enters the lung, liver, spleen, stomach, and pericardium meridians.

Functions and Indications

[0026] Fritillaria thunbergii: Bitter, cold. Enters the Lung and Heart meridians. [Functions and Indications] Clears heat and dissipates nodules, resolves phlegm and relieves cough. Used for wind-heat invading the lungs, cough with phlegm and fire, lung abscess, mastitis, scrofula, and carbuncles.

[0027] Cat's Claw Herb: Sweet, pungent, and warm in nature. It enters the liver and lung meridians.

Functions and Indications

[0028] Gleditsia sinensis thorns: pungent in taste and warm in nature. Enters the liver and stomach meridians.

Functions and Indications

[0029] Curcuma zedoaria: pungent, bitter, and warm. It enters the liver and spleen meridians.

Functions and Indications

[0030] Buckwheat: Slightly pungent, astringent, and cool in nature. It enters the Lung meridian.

Functions and Indications

[0031] Prepared licorice root: Sweet, neutral. Enters the heart, lung, spleen, and stomach meridians.

Functions and Indications

[0032] In the formulation of the herbal composition for resolving phlegm, promoting blood circulation, and dispersing nodules provided in this embodiment, turtle shell and oyster shell are used in large quantities to soften hardness and disperse nodules, and to unblock the meridians and relieve pain; soapberry thorn and cat's claw grass assist turtle shell and oyster shell in softening hardness, dispersing nodules, and resolving phlegm; turmeric breaks up blood stasis and clears the meridians; prepared pinellia, white mustard seed, and fritillaria thunbergii remove phlegm and dampness; buckwheat clears the lungs, drains pus, and removes blood stasis; scutellaria clears heat, dries dampness, purges fire, and detoxifies; ginseng tonifies qi and strengthens the body; and prepared licorice harmonizes all the herbs.

[0033] Clinical report:

[0034] Materials and Methods

[0035] 1. General Information:

[0036] 120 patients with pulmonary nodules of the phlegm-blood stasis type, with benign pulmonary nodules ≤8mm, were randomly divided into 4 groups of 30 patients each, and the clinical study lasted for 3 months.

[0037] 2. Clinical research methods:

[0038] The group was divided into four groups: control group, treatment group 1, treatment group 2, and treatment group 3. Treatment groups 1, 2, and 3 received a decoction of the expectorant, blood-activating, and nodule-dispersing composition orally three times daily, with each dose being 100 mL. The control group received standard basic treatment for benign pulmonary nodules without intervention. The treatment period for all three groups was three months. After the treatment period, symptom scoring and chest CT scans were performed.

[0039] Treatment Group 1's decoction and treatment method were as follows: 20g of turtle shell and 20g of oyster shell were placed in a decoction pot, 1100mL of water was added, and the decoction was boiled for 30 minutes. Then, 5g of Scutellaria baicalensis, 10g of Pinellia ternata, 5g of ginseng, 10g of white mustard seed, 10g of Fritillaria thunbergii, 10g of Uncaria rhynchophylla, 5g of Gleditsia sinensis thorns, 5g of Curcuma zedoaria, 10g of Fagopyrum dibotrys, and 5g of Glycyrrhiza uralensis were added, and the decoction was continued for 30 minutes. The mixture was filtered to obtain 300mL of filtrate. The decoction was taken warm, 100mL three times a day after meals (morning, noon, and evening). During the treatment period, spicy and cold foods should be avoided, wind and cold should be avoided, emotions should be regulated, and daily life should be carefully managed.

[0040] Treatment Group 2's decoction and treatment method were as follows: 20g of turtle shell and 20g of oyster shell were placed in a decoction pot with 1050mL of water and simmered for 30 minutes after boiling. Then, 5g of Scutellaria baicalensis, 5g of Pinellia ternata, 5 parts of ginseng, 5g of white mustard seed, 5g of Fritillaria thunbergii, 5g of Uncaria rhynchophylla, 10g of Gleditsia sinensis thorns, 10g of Curcuma zedoaria, 5g of Fagopyrum dibotrys, and 5g of Glycyrrhiza uralensis were added. The decoction was continued for another 30 minutes, filtered, and 300mL of filtrate was obtained. The decoction was taken warm, 100mL three times a day after meals (morning, noon, and evening). During the treatment period, spicy and cold foods should be avoided, wind and cold should be avoided, emotions should be regulated, and daily life should be carefully managed.

[0041] The treatment group 3's decoction and treatment method were as follows: 20g of turtle shell and 20g of oyster shell were placed in a decoction pot with 1000mL of water and simmered for 30 minutes after boiling. Then, 5g each of Scutellaria baicalensis, Pinellia ternata, Ginseng, Sinapis alba, Fritillaria thunbergii, Uncaria rhynchophylla, Gleditsia sinensis thorns, Curcuma zedoaria, Fagopyrum dibotrys, and Glycyrrhiza uralensis were added. The decoction was continued for another 30 minutes, filtered, and 300mL of filtrate was obtained. The decoction was taken warm, 100mL each time, three times a day after meals (morning, noon, and evening). During the treatment period, spicy and cold foods should be avoided, wind and cold should be avoided, emotions should be regulated, and daily life should be carefully managed.

[0042] The general basic treatment for the control group was as follows: no intervention measures were taken for the patients in the control group. They were advised to avoid spicy and cold foods, avoid wind and cold, regulate their emotions, and be careful about their daily life.

[0043] 3. The test results are as follows:

[0044] The symptom scores are shown in Table 1:

[0045] Table 1 shows the effective rate of pulmonary nodules in the control group and the treatment group.

[0046] Group Clinical efficacy rate (%) control group 78.53 Treatment group 1 91.45 Treatment group 2 94.12 Treatment group 3 96.78

[0047] Among them, effective evaluation criteria

[0048] 1) A follow-up chest CT scan three months later showed that the lesion in the same location had disappeared;

[0049] 2) A follow-up chest CT scan 3 months later showed that the lesion at the same location had shrunk by ≥1mm.

[0050] 3) A follow-up chest CT scan three months later showed no change in the lesion at the same location, but the patient's symptoms improved (the criteria for judging symptom improvement are only noted).

[0051] Invalid evaluation criteria

[0052] 1) A follow-up chest CT scan 3 months later showed an increase in lesion size of ≥1mm at the same location.

[0053] 2) Three months later, a follow-up chest CT scan showed that the lesion at the same location was stable or the lesion had shrunk by ≥1mm but showed signs of lobulation, spiculation or pleural indentation.

[0054] Note: Evaluation of symptom improvement (significant effect and effectiveness are considered symptom improvement):

[0055] The efficacy index n = (pre-treatment score - post-treatment score) / pre-treatment score × 100%, where the full score is 100 points, and the pre-treatment score and post-treatment score are scored by the attending physician.

[0056] Significant effect: Symptoms basically or completely disappear, or n≥70%;

[0057] Effective: Symptoms improved, n≥30%;

[0058] No improvement: Symptoms showed no significant improvement, n<30%;

[0059] Symptoms worsen: Symptoms worsen, n<0.

[0060] The results of the chest CT scan are shown in Table 2:

[0061] Table 2 shows the chest CT scan results for the control group and the treatment group.

[0062]

[0063] The results showed that compared with the control group, the treatment group not only improved the clinical efficacy of pulmonary nodules, but also maintained or reduced the size of benign pulmonary nodules to a certain extent, and was mainly used to treat pulmonary nodules of the phlegm-blood stasis obstructing the lungs type.

[0064] In this embodiment, the same drugs were used in the treatment groups, but the dosages differed. In treatment group 1, the dosages of Pinellia ternata, Sinapis alba, Fritillaria thunbergii, Uncaria rhynchophylla, and Fagopyrum cymosum were relatively large. These five drugs are mainly used to resolve phlegm and dissipate nodules. Pinellia ternata has the effects of drying dampness and resolving phlegm, eliminating masses and dissipating nodules, and relieving nausea and vomiting. It is used for symptoms such as cough with excessive phlegm, goiter, scrofula, sores and swelling, globus hystericus, stomach upset, nausea and vomiting, chest tightness, chest pain, and chest congestion. The tuber contains volatile oil, a small amount of fat, various amino acids, ephedrine, trigonelline, and alkaloids with pharmacological effects similar to coniine. Pharmacological experiments have shown that the dilute alcohol or water extract of Pinellia ternata has a significant inhibitory effect on experimental tumors in animals. The *Ben Cao Zheng Yi* (Correct Interpretation of Materia Medica) states that "white mustard seed quickly eliminates phlegm, lumps, and abdominal distension. Because of its strong flavor and light aroma, it opens up quickly without consuming much qi. Since it can remove phlegm from the ribs and skin, its effect on other nearby areas is self-evident." Fritillaria thunbergii not only resolves phlegm and dissipates nodules, but modern pharmacological research shows that it also has a protective effect on the lungs and is used to treat lung diseases. Studies have found that phytosterols and polysaccharides in Fritillaria thunbergii can promote lung cell growth and repair, reducing lung damage. Cat's claw herb has a pungent flavor and is good at dispersing phlegm and stagnation in the body, with significant effects in dispersing phlegm and stagnation. Pharmacological studies show that cat's claw herb has antibacterial, antiviral, antitumor, and immune-enhancing effects. Buckwheat clears heat and detoxifies, removes blood stasis and drains pus. Pharmacological studies show that its active ingredients can inhibit bacteria, fight cancer, and enhance immunity. In treatment group 2, the dosage of Gleditsia sinensis thorns and Curcuma zedoaria was relatively large, enhancing the blood-activating effect of the formula. In treatment group 3, the dosage of ginseng was relatively large, while the dosage of drugs for expelling pathogens was relatively small compared to treatment groups 1 and 2. Firstly, as the "Suwen" states, "Where pathogens gather, the qi must be deficient," so increasing the dosage of ginseng addresses the root cause. Secondly, although drugs for expelling pathogens can enhance the effects of resolving phlegm, dispersing nodules, and promoting blood circulation to achieve the effect of expelling pathogens, they inevitably damage the body's vital energy.

[0065] Case 1

[0066] This embodiment provides a traditional Chinese medicine composition for a phlegm-resolving, blood-activating, and nodule-dispersing decoction, which consists of the following raw materials in parts by weight: 20g of turtle shell, 20g of oyster shell, 5g of scutellaria baicalensis, 10g of prepared pinellia ternata, 5g of ginseng, 10g of white mustard seed, 10g of fritillaria thunbergii, 10g of cat's claw herb, 5g of soapberry thorn, 5g of turmeric, 10g of buckwheat, and 5g of prepared licorice root.

[0067] Patient 1, female, 26 years old, presented with cough with phlegm, fatigue, pale and dark tongue with a slippery coating and a yellow and greasy pulse. Treatment focused on resolving phlegm, promoting blood circulation, dispersing nodules and lumps, and tonifying qi and strengthening the body (with a bias towards resolving phlegm). The herbal composition of the Phlegm-Resolving, Blood-Activating, and Nodule-Dispersing Decoction from Example 1 was selected. First, the above-mentioned turtle shell and oyster shell were placed in a decoction pot, 1000mL of water was added, and the decoction was simmered for 30 minutes. Then, the above-mentioned Scutellaria baicalensis, Pinellia ternata, ginseng, white mustard seed, Fritillaria thunbergii, Uncaria rhynchophylla, Gleditsia sinensis thorns, Curcuma zedoaria, Fagopyrum dibotrys, and Glycyrrhiza uralensis were added, and the decoction was continued for another 30 minutes. The decoction was filtered, and the filtrate was concentrated to 300mL to obtain the decoction of the herbal composition for dispersing nodules, resolving phlegm, and promoting blood circulation. The decoction was taken warm, 100mL three times a day after meals (morning, noon, and evening). During the medication period, spicy and cold foods should be avoided, wind and cold should be avoided, emotions should be regulated, and daily life should be carefully managed. After one course of treatment (one course of treatment is one month), the symptoms improved (see the relevant notes on the evaluation of the degree of symptom improvement above for the criteria for judging symptom improvement).

[0068] Case 2

[0069] This embodiment provides a traditional Chinese medicine composition for a phlegm-resolving, blood-activating, and nodule-dispersing decoction, which is composed of the following raw materials in parts by weight: 20g of turtle shell, 20g of oyster shell, 5g of scutellaria baicalensis, 5g of prepared pinellia ternata, 5g of ginseng, 5g of white mustard seed, 5g of fritillaria thunbergii, 5g of cat's claw herb, 10g of soapberry thorn, 10g of turmeric, 5g of buckwheat, and 5g of prepared licorice root.

[0070] Patient 2, female, 56 years old, presented with cough with phlegm, chest tightness, fatigue, dark tongue with ecchymosis and petechiae, varicose veins under the tongue, yellow and greasy tongue coating, and wiry pulse. Treatment focused on resolving phlegm, promoting blood circulation, dispersing nodules and lumps, and tonifying qi and strengthening the body (leaning towards promoting blood circulation). The herbal composition of the Phlegm-Resolving, Blood-Activating, and Nodule-Dispersing Decoction from Example 2 was selected. First, the aforementioned turtle shell and oyster shell were placed in a decoction pot, 1000mL of water was added, and the decoction was simmered for 30 minutes. Then, the aforementioned Scutellaria baicalensis, Pinellia ternata, ginseng, white mustard seed, Fritillaria thunbergii, Uncaria rhynchophylla, Gleditsia sinensis thorns, Curcuma zedoaria, Fagopyrum dibotrys, and Glycyrrhiza uralensis were added, and the decoction was continued for another 30 minutes. The decoction was filtered, and the filtrate was concentrated to 300mL to obtain the decoction of the herbal composition for resolving phlegm, dispersing nodules, and promoting blood circulation. The patient was to take 100mL three times a day after meals, warm. During the treatment period, spicy and cold foods were avoided, wind and cold were prevented, emotions were regulated, and daily life was carefully managed. After one course of treatment, the symptoms improved.

[0071] Case 3

[0072] This embodiment provides a traditional Chinese medicine composition for a phlegm-resolving, blood-activating, and nodule-dispersing decoction, which is composed of the following raw materials in parts by weight:

[0073] 20g of turtle shell, 20g of oyster shell, 5g of scutellaria baicalensis, 5g of prepared pinellia ternata, 10g of ginseng, 5g of white mustard seed, 5g of fritillaria thunbergii, 5g of cat's claw herb, 5g of soapberry thorn, 5g of turmeric, 5g of buckwheat, and 5g of prepared licorice root.

[0074] Patient 3, male, 48 years old, presented with cough with phlegm, wheezing, fatigue, and weakness. His tongue was pale with a white, greasy coating, and his pulse was deep and thready. He sought medical attention. The treatment principle was to resolve phlegm, invigorate blood circulation, disperse nodules and lumps, and tonify Qi and strengthen the body (leaning towards tonifying Qi). The herbal composition of the Phlegm-Resolving, Blood-Activating, and Nodule-Dispersing Decoction from Example 3 was selected. First, the aforementioned turtle shell and oyster shell were placed in a decoction pot, and 1000mL of water was added and simmered for 30 minutes. Then, the aforementioned Scutellaria baicalensis, Pinellia ternata, ginseng, white mustard seed, Fritillaria thunbergii, Uncaria rhynchophylla, Gleditsia sinensis thorns, Curcuma zedoaria, Fagopyrum dibotrys, and Glycyrrhiza uralensis were added, and the decoction was continued for another 30 minutes. The decoction was filtered, and the filtrate was concentrated to 300mL to obtain the decoction of the Phlegm-Resolving, Nodule-Dispersing, and Blood-Activating Herbal Composition. The patient was to take 100mL three times a day after meals, warm. During the treatment period, the patient was advised to avoid spicy and cold foods, avoid wind and cold, regulate emotions, and be mindful of daily activities. After one course of treatment, the symptoms improved.

[0075] The decoction (Phlegm-resolving, blood-activating, and nodule-dispersing decoction) prepared by the traditional Chinese medicine composition for resolving phlegm, activating blood circulation, and dispersing nodules provided in this embodiment can not only effectively improve the clinical efficacy of pulmonary nodules, but also maintain or shrink the size of benign pulmonary nodules to a certain extent. It can effectively relieve common symptoms such as cough, phlegm, weakness, and fatigue caused by benign pulmonary nodules, improve the quality of life of patients, and has few side effects and high safety.

[0076] Compared to Reference 1 (CN115381914A "A Traditional Chinese Medicine Composition for Treating Pulmonary Nodules of Phlegm-Blood Stasis Type, Preparation Method and Application") and Reference 2 (CN114699502B "A Traditional Chinese Medicine Composition for Dispersing Nodules, Resolving Phlegm and Activating Blood Circulation, Preparation Method and Application"), this embodiment reduces the following components: Bupleurum, Belamcanda chinensis, Bombyx batryticatus, Prepared Ginger, Prepared Aconite Root, Red Peony Root, Cinnamon Twig, Lepidium Seed, Pyrrosia lingua, Moutan Bark, Cornus officinalis, Eupolyphaga sinensis, Vespa nidus, Peach Kernel, Cremastra appendiculata, and Magnolia officinalis. Among these, Peach Kernel, Eupolyphaga sinensis, Red Peony Root, and Moutan Bark break up blood stasis and clear the meridians, while this invention retains Curcuma zedoaria to activate blood circulation and remove blood stasis; Cremastra appendiculata has been shown to have anti-tumor properties in modern pharmacological studies, but it is pungent and cold in nature, and is used to clear heat and detoxify, reduce swelling and disperse nodules, mainly treating carbuncles, malignant sores, scrofula, tuberculosis, and sore throat. Expectorants, blood-activating and stasis-removing drugs, and heat-clearing and detoxifying drugs are all used to expel pathogens, while ginseng is the only tonifying agent. Considering the patient's pathogenesis, this combination might easily deplete the body's vital energy. The *Suwen* (Plain Questions) states, "Where pathogens gather, the vital energy must be deficient," emphasizing the dominant role of the body's vital energy in disease development. Therefore, this example includes roasted licorice root to both tonify the vital energy and harmonize the other drugs. Furthermore, both of these methods could damage the spleen and stomach. The spleen governs transportation, and the stomach governs transformation; therefore, the combination of drugs and food... Similarly, all these conditions require the digestive and absorptive functions of the spleen and stomach. Most of the aforementioned medications are cold in nature, which can easily obstruct the flow of Qi in the spleen and stomach, affecting the function of the middle Jiao and leading to the internal generation of phlegm and dampness. Therefore, the bitter and cold herbs such as Lepidium apetalum, Pyrrosia lingua, and Belamcanda chinensis were removed, and only Fagopyrum dibotrys and Scutellaria baicalensis were used to clear lung heat, detoxify, and dry dampness. Although Beehive and Bombyx mori can penetrate the nest and reach the affected area directly, both are expelling pathogens, and insect-based drugs have a strong expelling effect. Considering the weak constitution of these patients, these medications were not used. I use: Prepared ginger is pungent and hot in nature, and processed aconite root is extremely pungent and hot, entering the spleen and stomach meridians. It is often used to treat abdominal pain and diarrhea caused by spleen and stomach deficiency and cold. Cinnamon twig is used to warm the yang and transform qi, warm the meridians and unblock the vessels, and there is a principle that "for those with phlegm and fluid retention, warm medicines should be used to harmonize them." However, considering this treatment principle, it is mainly suitable for phlegm and fluid retention caused by spleen yang deficiency, and the effect is better when combined with poria, atractylodes macrocephala, and other drugs. However, its pathogenesis is not suitable for this type of pulmonary nodule patient; Cornus officinalis is used to tonify... This formula primarily benefits the liver and kidneys, and has astringent and consolidating properties. However, liver and kidney deficiency is rare in this type of patient, and this formula is often greasy and can impair digestion, so it is not used here. Magnolia officinalis dries dampness, eliminates phlegm, and relieves fullness. It mainly enters the spleen and stomach meridians and is used to treat indigestion and abdominal distension. Although Bupleurum chinense can regulate the body's functions, it can easily deplete liver yin. Since the treatment period for this disease is long, it should ideally be combined with liver-soothing herbs. However, this embodiment strives for fewer herbs and more focused effects. To prevent the dispersion of medicinal power, the formula has been reduced. After long-term clinical observation, the efficacy of this embodiment is indeed excellent.

[0077] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Those skilled in the art can readily implement the present invention according to the description and above. However, any modifications, alterations, or variations made by those skilled in the art without departing from the scope of the present invention, based on the disclosed technical content, are equivalent embodiments of the present invention. Furthermore, any equivalent changes, alterations, or variations made to the above embodiments based on the essential technology of the present invention are still within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating pulmonary nodules of the phlegm-blood stasis type, characterized in that, The ingredients are composed of the following components by weight: 20 parts turtle shell, 20 parts oyster shell, 5 parts scutellaria baicalensis, 5-10 parts prepared pinellia ternata, 5 or 10 parts ginseng, 5-10 parts white mustard seed, 5-10 parts Zhejiang fritillary bulb, 5-10 parts cat's claw herb, 5-10 parts soapberry thorn, 5-10 parts turmeric, 5-10 parts buckwheat, and 5 parts prepared licorice root.

2. The traditional Chinese medicine composition for treating pulmonary nodules of the phlegm-blood stasis type according to claim 1, characterized in that, The ingredients are composed of the following components by weight: 20 parts turtle shell, 20 parts oyster shell, 5 parts scutellaria baicalensis, 5 or 10 parts prepared pinellia ternata, 5 or 10 parts ginseng, 5 or 10 parts white mustard seed, 5 or 10 parts Zhejiang fritillary bulb, 5 or 10 parts cat's claw herb, 5 or 10 parts soapberry thorn, 5 or 10 parts turmeric, 5 or 10 parts buckwheat, and 5 parts prepared licorice root.

3. A method for preparing a traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type, characterized in that, The preparation method is to decoct the traditional Chinese medicine composition for treating pulmonary nodules of the phlegm-blood stasis type as described in any one of claims 1-2 with water, filter the filtrate, and then concentrate the filtrate to obtain the traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type.

4. The method for preparing the traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type according to claim 3, characterized in that, The specific decoction process for treating pulmonary nodules of the phlegm-blood stasis type is as follows: Boil turtle shell and oyster shell in water for 20-40 minutes, then add scutellaria baicalensis, pinellia ternata, ginseng, white mustard seed, fritillaria thunbergii, cat's claw herb, gleditsia sinensis thorn, turmeric, buckwheat and prepared licorice root and continue to decoct for another 20-40 minutes.

5. The method for preparing the traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type according to claim 3, characterized in that, The mass-to-volume ratio of the traditional Chinese medicine composition for treating pulmonary nodules of the phlegm-blood stasis type to water is at least 0.5 g / mL.

6. The method for preparing the traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type according to claim 3, characterized in that, The filtrate is concentrated to 0.3-0.4 g / mL, based on the traditional Chinese medicine composition for treating pulmonary nodules of the phlegm-blood stasis type.

7. The method for preparing the traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type according to claim 3, characterized in that, The concentration method is heating concentration.

8. A traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type, characterized in that, It is prepared by the preparation method described in any one of claims 3-7.

9. The use of a traditional Chinese medicine composition for treating pulmonary nodules of the phlegm-blood stasis type as described in any one of claims 1-3, or a traditional Chinese medicine decoction for treating pulmonary nodules of the phlegm-blood stasis type as described in claim 8, in the preparation of a drug for treating pulmonary nodules of the phlegm-blood stasis type.

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