Pharmaceutical composition for tonifying qi, activating blood and removing stasis as well as preparation and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, and discloses a qi-tonifying, blood-activating and stasis-removing pharmaceutical composition and a preparation and application thereof, the pharmaceutical composition comprises 10-30 parts of companumoea root, 5-20 parts of radix tetrastigme, 10-20 parts of rubia yunnanensis, 5-15 parts of zingiber officinale and 5-15 parts of crepis phoenix. The preparation method comprises the following steps: mixing an alcohol extract and a water extract of the pharmaceutical composition with pharmaceutically acceptable auxiliary materials required by the preparation to prepare capsules or pills. Experiments prove that the composition has good effects of tonifying qi, activating blood and removing stasis, is used for dissipating lung nodules of qi deficiency and blood stasis type patients, achieves a remarkable treatment effect, and is free of toxic and side effects, safe and reliable. Wide application prospects are realized.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a medicine composition for invigorating qi, promoting blood circulation and dispersing stagnation, and a preparation and application thereof. Background Art

[0002] The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.

[0003] With the application of high-resolution CT, the detection rate of lung nodules has gradually increased. Lung nodules refer to focal, rounded, solid or subsolid lung shadows with a diameter of ≤3 cm, which may be solitary or multiple, without atelectasis, hilar lymphadenopathy, and pleural effusion. Among people who undergo chest CT examinations, the detection rate of lung nodules is 20% to 50%. Although most lung nodules are benign nodules, especially those with smaller diameters, some nodules will evolve into precancerous lesions or early lung cancer. Early lung cancer or precancerous lesions of lung cancer mainly appear in the form of lung nodules on imaging. Lung nodules are a key window for early diagnosis and treatment of lung cancer.

[0004] At present, modern medicine manages lung nodules by performing positron emission tomography / computed tomography (PET / CT) examinations and biopsies to determine whether they are benign or malignant, or directly performing surgical resection of high-risk nodules. In addition, most patients with lung nodules are only given follow-up expectant treatment based on regular imaging review or blind intervention with some antibacterial drugs. Traditional Chinese medicine has the advantages of syndrome differentiation, overall regulation, and full-process management, and can participate in the construction and improvement of the diagnosis and treatment system of lung nodules in a full cycle and in multiple dimensions. Therefore, it is very necessary to explore the basic treatment methods of traditional Chinese medicine intervention for lung nodules, further give play to the advantages of traditional Chinese medicine in "preventive treatment", and develop a drug that can treat both the symptoms and the root causes and dissipate lung nodules. Summary of the invention

[0005] The purpose of the present invention is to provide a medicine composition for invigorating qi, activating blood circulation and dispersing nodules, and its preparation and application, in response to the problem of lack of intervention means and drugs for lung nodules in current modern medicine, so as to solve the problem of lack of intervention drugs for lung nodules, give full play to the advantage of traditional Chinese medicine of "preventive treatment", treat both the symptoms and the root cause, dissipate lung nodules, and avoid further evolution of nodules.

[0006] The technical solution of the present invention is as follows:

[0007] On one hand, the present invention provides a medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation, which is composed of the following components by weight: 10-30 parts of Codonopsis pilosula, 5-20 parts of Tripterygium wilfordii, 10-20 parts of Small Red Ginseng, 5-15 parts of Black Heart Ginger and 5-15 parts of Wanzhangshen.

[0008] According to a preferred embodiment, the composition is composed of the following components by weight: 12-28 parts of Codonopsis pilosula, 7-18 parts of Tripterygium wilfordii, 12-18 parts of Small Red Ginseng, 7-18 parts of Black Heart Ginger, and 7-18 parts of Wanzhangshen.

[0009] According to a preferred embodiment, the composition is composed of the following components by weight: 15-25 parts of Codonopsis pilosula, 8-16 parts of Tripterygium wilfordii, 13-18 parts of Small Red Ginseng, 10-15 parts of Black Heart Ginger, and 10-15 parts of Wanzhangshen.

[0010] There is no name for lung nodules in traditional Chinese medicine. Based on clinical manifestations, traditional Chinese medicine classifies them into categories such as "lung accumulation", "phlegm nodules" and "cough". "Medical Essential Reading" states: "Accumulation is caused by insufficient righteousness, which is then occupied by evil qi". Deficiency of righteousness is the root cause of lung nodules. Innate deficiency or long-term illness damages lung qi, the body's ability to resist external evil is reduced, qi is out of balance, and vital energy is weak, which can easily lead to abnormal metabolism of lung fluids, stagnation of water and moisture, and phlegm, which hinders qi and blood, and blood stasis. The lungs are rich in veins, and phlegm and blood stasis accumulate in the lung veins for a long time, resulting in nodules. In the pharmaceutical composition of the present application, Radix Codonopsis pilosulae is sweet, slightly bitter, warm in nature, non-toxic, enters the lung, spleen, and kidney meridians, and is included in the Quality Standards for Traditional Chinese and Ethnic Medicinal Materials in Guizhou Province (2003 Edition) and has the effects of tonifying the middle and replenishing qi, moistening the lungs and promoting the production of body fluid, stopping bleeding, and promoting lactation; Radix Tripterygii is bitter and pungent in taste, flat in nature, and has the effects of dispersing stagnation and reducing swelling, clearing away heat and detoxifying, and dispelling wind and resolving phlegm; the two are used together as the monarch medicine to replenish the middle and replenish qi, dispersing stagnation and reducing swelling. The minister medicine, Radix Codonopsis pilosulae, was first seen in the Southern Yunnan Materia Medica written by Lan Mao, which stated in the book that "purple ginseng, bitter, sweet and flat, slightly warm in nature; it circulates through the twelve meridians". As a unique ethnic medicine in Yunnan, it is included in the Yunnan Provincial Drug Standards and the Chinese Pharmacopoeia (1977 Edition). The Yunnan National Medicine Records records that the Bai and Yi people believe that small red ginseng is sweet and flat in nature, and has the effects of softening and breaking up knots, replenishing blood and activating blood circulation, removing blood stasis and promoting new blood, and calming the nerves. It is combined with the main medicine to activate blood circulation, remove blood stasis, and disperse knots. The adjuvant black heart ginger tastes bitter and pungent, is warm in nature, non-toxic, enters the lung and spleen meridians, promotes qi and breaks blood, stimulates appetite and digestion, and relieves pain. It is the "key medicine for breaking blood and removing blood stasis"; it is supplemented with the main and auxiliary medicines to break blood and remove blood stasis and promote qi and help disperse knots. The auxiliary medicine Wanzhangshen tastes slightly sweet and bitter, is cool in nature, enters the lung and liver meridians, and has the effects of strengthening the spleen and eliminating accumulation, clearing away heat and detoxifying, moistening the lungs and relieving cough, eliminating carbuncle, and replenishing deficiency. First, it can prevent the whole prescription from being too warm and dry and hurting yin, and second, it can strengthen the spleen. If the spleen is healthy, the qi and blood will be active and run normally. The combination of various medicines can treat both the symptoms and the root causes, and together they can replenish qi and activate blood circulation, remove blood stasis and disperse knots. It is used to dissipate lung nodules in patients with qi deficiency and blood stasis.

[0011] Pharmacological analysis:

[0012] Codonopsis pilosula: It is the dried root of Campanumoea javanicaBL.subsp.japonica (Makino) Hong of the Campanulaceae family. It is a perennial herb and is often distributed in roadside grass and bushes below 2400m above sea level. It is sweet in nature, flat in taste, and enters the spleen and lung meridians. It has the effects of tonifying the middle and replenishing qi, moistening the lungs and promoting fluid production, stopping bleeding, and promoting lactation. It is mainly used to treat physical weakness after illness, cough due to lung deficiency, sweating, neurasthenia, malnutrition in children, loss of appetite, chronic diarrhea, and postpartum milk retention. Modern research shows that Codonopsis pilosula contains polysaccharides, acetylene glycosides, saponins, flavonoids and other components, among which acetylene glycosides and total polysaccharides are the main ones. Codonopsis pilosula acetylene glycosides have anti-tumor, anti-ulcer, anti-inflammatory, and anti-pathogenic microorganism effects, and total polysaccharides have anti-fatigue, immune enhancement, anti-hypoxia, and anti-cerebral ischemia.

[0013] Three-leaf green: It is a fresh or dried root of a perennial herbaceous climbing vine of the genus Tetrastigma in the Vitaceae family. It is also known as three-leaf green, golden thread hanging gourd, snake aconite, stone mouse, etc. It tastes bitter and pungent, is neutral in nature, and has the effects of clearing away heat and detoxifying, dispelling wind and resolving phlegm, dispersing nodules and reducing swelling. Modern research shows that it includes a variety of compounds such as flavonoids, phenolic acids, polysaccharides, volatile oils and fatty acids, and flavonoids and polysaccharides are the main biologically active components of three-leaf green, which has anti-tumor, anti-inflammatory, antibacterial, antiviral and immunomodulatory effects.

[0014] Small red ginseng: The dried root of Rubia yunnanensis (Fr.) Diels., a plant of the Rubiaceae family; mainly grown in weeds or roadsides under sparse forests on sunny hillsides; distributed in central, northwestern and northeastern Yunnan. It tastes sweet and flat, and has the effects of softening and breaking up lumps, replenishing blood and activating blood circulation, removing blood stasis and promoting new blood circulation, and calming the nerves. More than 30 chemical components extracted and separated from small red ginseng have been reported so far, with anthraquinones and their glycosides and triterpenes accounting for the majority. In addition, cyclohexyl peptides, naphthoquinones and other components have also been isolated. Modern pharmacological experiments have shown that the extract of small red ginseng has anti-tumor, anti-myocardial ischemia, T lymphocyte regulation, and expectorant effects.

[0015] Black-hearted ginger: It is the dried rhizome of Curcuma phaeocaulis VaL, Curcuma wangsiensis SGLee et CFLiang or Curcuma wenyujin YHChen et C.Ling, plants of the ginger family. It tastes pungent and bitter, is warm in nature, and enters the liver and spleen meridians. It has the effects of eliminating accumulation and relieving pain, breaking blood and removing blood stasis, and is a "key medicine for breaking blood and removing blood stasis". Modern research shows that black-hearted ginger contains volatile oils and curcumin active chemical components, both of which have anti-tumor, anti-coagulation, anti-platelet aggregation and other effects.

[0016] Wanzhangshen: It is a perennial herb of the genus Huanyangshen in the Asteraceae family. Its root is used as medicine. It has the effects of nourishing the lungs, clearing away heat and detoxifying, promoting digestion and regulating qi, and promoting lactation. It is used to treat dizziness due to physical weakness, limb weakness, pneumonia, bronchitis, malnutrition in children, insufficient milk in women, muscle and bone pain, traumatic injuries, sores, boils, and swelling. Modern pharmacological studies have shown that it contains tannic acid, polysaccharides, sugars, glycosides, volatile oils, and reducing compounds, and has anti-cancer, anti-inflammatory, anti-thrombotic, liver-protecting, and lipid-lowering effects.

[0017] Another aspect of the present invention provides a pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing stagnation, comprising an ethanol extract and a water extract of the pharmaceutical composition for invigorating qi, promoting blood circulation and dispersing stagnation as described above and pharmaceutically acceptable excipients required for the preparation.

[0018] According to a preferred embodiment, the preparation is a capsule or a pill.

[0019] According to a preferred embodiment, the capsule is prepared by the following preparation method:

[0020] Step (1): extracting with ethanol to obtain an alcohol extract of a medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules, and adding water to the medicinal residue after the alcohol extraction to obtain a water extract;

[0021] Step (2): the alcohol extract and the water extract are concentrated and then mixed, and dried and crushed to obtain a dry paste powder;

[0022] Step (3): adding auxiliary materials to the dry paste powder prepared in step (2), and mixing to obtain a mixture;

[0023] Step (4): add 60%-80% ethanol to the mixture to obtain wet granules, dry at 55-75°C to obtain dry granules, add a lubricant, mix thoroughly, and then fill into hollow capsule shells to obtain the Qi-invigorating, blood-activating and knot-dispersing medicinal composition capsules.

[0024] Preferably, step (1) specifically includes the following sub-steps:

[0025] Step (1.1): Weigh each herb according to the formula, dry and crush them respectively, and mix them evenly to obtain a mixed material;

[0026] Step (1.2): adding 65%-75% ethanol by volume to the mixed material for reflux extraction, wherein the amount of ethanol added is 6-8 times the mass of the mixed material, the extraction time is 1-2 hours, the extraction is repeated 1-2 times, each time using an equal amount of ethanol, and filtering to obtain a filtrate and a medicinal residue;

[0027] Step (1.3): recovering ethanol from the filtrate under reduced pressure to obtain an alcohol extract; then adding water to the medicinal residue for extraction once, with the mass ratio of medicinal residue to water being 1:7-10, and the extraction time being 1-2 hours, to obtain a water extract.

[0028] Preferably, step (2) specifically comprises: concentrating the alcohol extract and the water extract at 60-80° C. respectively to obtain an extract with a relative density of 1.20-1.35, mixing the extracts, and obtaining a dry paste powder with a water content of 6%-8% after drying and crushing.

[0029] Preferably, the auxiliary materials described in step (3) include starch, lactose and microcrystalline cellulose, and the mass ratio of dry cream powder, starch, lactose and microcrystalline cellulose is: 1: 0.1-0.2: 0.1-0.2: 0.1-0.2.

[0030] Preferably, the lubricant in step (4) is selected from at least one of silicon dioxide and magnesium stearate, and the total amount is 0.6%-1% of the dry particles.

[0031] Preferably, in step (4), each capsule contains 0.6 g.

[0032] According to a preferred embodiment, the pills are prepared by the following preparation method:

[0033] Step (1): extracting with ethanol to obtain an alcohol extract of a medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules, and adding water to the medicinal residue after the alcohol extraction to obtain a water extract;

[0034] Step (2): the alcohol extract and the water extract are concentrated and then mixed, and dried and crushed to obtain a dry paste powder;

[0035] Step (3): adding a disintegrant to the dry paste powder prepared in step (2), and mixing to obtain a mixture;

[0036] Step (4): adding 60%-80% ethanol to the mixture prepared in step (3) to prepare micropills, and drying to obtain the Qi-invigorating, blood-activating and knot-dispersing medicinal composition pills.

[0037] Preferably, step (1) specifically includes the following sub-steps:

[0038] Step (1.1): Weigh each herb according to the formula, dry and crush them respectively, and mix them evenly to obtain a mixed material;

[0039] Step (1.2): adding 65%-75% ethanol by volume to the mixed material for reflux extraction, wherein the amount of ethanol added is 6-8 times the mass of the mixed material, the extraction time is 1-2 hours, the extraction is repeated 1-2 times, each time using an equal amount of ethanol, and filtering to obtain a filtrate and a medicinal residue;

[0040] Step (1.3): recovering ethanol from the filtrate under reduced pressure to obtain an alcohol extract; then adding water to the medicinal residue for extraction once, with the mass ratio of medicinal residue to water being 1:7-10, and the extraction time being 1-2 hours, to obtain a water extract.

[0041] Preferably, step (2) specifically comprises: concentrating the alcohol extract and the water extract at 60-80° C. respectively to obtain an extract with a relative density of 1.20-1.35, mixing the extracts, and obtaining a dry paste powder with a water content of 6%-8% after drying and crushing.

[0042] Preferably, the disintegrant in step (3) is selected from at least one of sodium carboxymethyl starch CMS-Na, cross-linked sodium carboxymethyl cellulose CC-Na, cross-linked polyvinylpyrrolidone PVPP, low-substituted hydroxypropyl cellulose L-HPC, and microcrystalline cellulose MCC, and the total amount of the disintegrant is 0.6%-1% of the mass of the dry paste powder prepared in step (2).

[0043] Preferably, after drying in step (4), the pills of the Qi-invigorating, blood-activating and knot-dispersing pharmaceutical composition are subjected to pill selection.

[0044] Another aspect of the present invention provides a use of the aforementioned medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules in the preparation of a medicament for treating qi deficiency and blood stasis type pulmonary nodules.

[0045] Another aspect of the present invention provides a use of the aforementioned medicinal composition preparation for invigorating qi, promoting blood circulation and dispersing nodules in the preparation of a medicine for treating qi deficiency and blood stasis type pulmonary nodules.

[0046] Compared with the prior art, the present invention has the following beneficial effects:

[0047] 1. Provide a medicinal composition for invigorating qi, activating blood circulation and dispersing nodules, wherein Radix Codonopsis pilosulae and Radix Tripterygii are used together as the main medicine, and have the effects of invigorating the middle qi, dispersing nodules and reducing swelling; Radix Codonopsis pilosulae is used as the ministerial medicine, and Ginger chinensis is used as the adjuvant medicine, and the main and ministerial medicines are used to break blood, dissolve blood stasis, and promote qi circulation to help dispersing nodules; the combination of the medicines is very effective, and the medicines are used together, with the treatment focus on invigorating the middle qi, activating blood circulation and dispersing blood stasis, and dispersing nodules and reducing swelling, treating both the symptoms and the root causes, and having the effects of invigorating qi, activating blood circulation, and dispersing nodules, and being used to dissipate the lung nodules of patients with qi deficiency and blood stasis, and having achieved remarkable therapeutic effects, and having no toxic side effects, and being safe and reliable;

[0048] 2. A pharmaceutical composition preparation for invigorating qi, activating blood circulation and dispersing nodules is also provided. The Chinese medicine composition is prepared into capsules or pills for use, which has the advantages of being convenient to use, easy to store and take; it can perform long-term sustained release of the drug, which is beneficial to the application of Chinese medicine resources;

[0049] 3. A pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing nodules, which adopts a combination of alcohol extraction and water extraction to extract and collect the effective ingredients in the composition, and then mix the effective ingredients to prepare the pharmaceutical preparation; it can fully extract the effective ingredients in the pharmaceutical composition; it is applied to the treatment of qi deficiency and blood stasis type lung nodules, forming a unique preparation of Yunnan's ethnic medicine resources, with scientific prescription and compatibility, reasonable materials, significant efficacy, safety and no side effects. DETAILED DESCRIPTION

[0050] The specific embodiments listed in the present invention are only examples of the present invention, and the present invention is not limited to the specific embodiments described below. For those skilled in the art, any equivalent modifications and substitutions to the embodiments described below are also within the scope of the present invention. Therefore, the equal transformations and modifications made without departing from the spirit and scope of the present invention should be included in the scope of the present invention. If the specific conditions are not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer. If the manufacturers are not specified for all reagents or instruments, they are all conventional products that can be purchased commercially. In order to better illustrate the present invention, numerous specific details are given in the specific embodiments below. It should be understood by those skilled in the art that the present invention can also be implemented without certain specific details. In other embodiments, the methods, means, equipment and steps well known to those skilled in the art are not described in detail in order to highlight the purport of the present invention.

[0051] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art. Unless otherwise specified, the units used in this specification are all international standard units, and the numerical values ​​and numerical ranges appearing in the present invention should be understood to include the inevitable systematic errors in industrial production.

[0052] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0053] Example 1 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0054] A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation is composed of the following components by weight: 30 parts of Codonopsis pilosula, 20 parts of Tripterygium wilfordii, 20 parts of Small Red Ginseng, 15 parts of Black Heart Ginger and 15 parts of Wanzhangshen.

[0055] Example 2 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0056] A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation is composed of the following components by weight: 10 parts of Codonopsis pilosula, 5 parts of Tripterygium wilfordii, 10 parts of Small Red Ginseng, 5 parts of Black Heart Ginger and 5 parts of Wanzhangshen.

[0057] Example 3 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0058] A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation is composed of the following components by weight: 12 parts of Codonopsis pilosula, 7 parts of Tripterygium wilfordii, 12 parts of Small Red Ginseng, 7 parts of Black Heart Ginger and 7 parts of Wanzhangshen.

[0059] Example 4 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0060] A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation is composed of the following components by weight: 28 parts of Radix Codonopsis pilosulae, 18 parts of Tripterygium wilfordii, 18 parts of Rhizoma Cibotii, 18 parts of Rhizoma Cibotii, 18 parts of Rhizoma Cibotii, and 18 parts of Rhizoma Cibotii.

[0061] Example 5 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0062] A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation is composed of the following components by weight: 15 parts of Codonopsis pilosula, 8 parts of Tripterygium wilfordii, 13 parts of Small Red Ginseng, 10 parts of Black Heart Ginger and 10 parts of Wanzhangshen.

[0063] Example 6 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0064] A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation is composed of the following components by weight: 25 parts of Codonopsis pilosula, 16 parts of Tripterygium wilfordii, 18 parts of Small Red Ginseng, 15 parts of Black Heart Ginger and 15 parts of Wanzhangshen.

[0065] Example 7 A medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0066] A medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules is composed of the following components in parts by weight: the medicinal composition includes 20 parts of Codonopsis pilosula, 12 parts of Tripterygium wilfordii, 15 parts of Small Red Ginseng, 12 parts of Black Heart Ginger and 12 parts of Wanzhangshen in parts by weight.

[0067] Example 8 Pills of a medicinal composition for replenishing qi, promoting blood circulation and dispersing nodules

[0068] According to the composition formula of Example 7, pills were prepared according to the following steps:

[0069] Step (1):

[0070] Step (1.1): weigh each herb according to the above-mentioned formula, dry and crush them respectively, and mix them evenly to obtain a mixed material;

[0071] Step (1.2): adding 65% ethanol by volume to the mixed material for reflux extraction, wherein the amount of ethanol added is 8 times the mass of the mixed material, the extraction time is 1 hour, and the extraction is repeated twice, using an equal amount of ethanol each time, and filtering to obtain a filtrate and a medicinal residue;

[0072] Step (1.3): recovering ethanol from the filtrate under reduced pressure to obtain an ethanol extract; then adding water to the medicinal residue for extraction once, with the mass ratio of medicinal residue to water being 1:10, and the extraction time being 1 hour, to obtain a water extract;

[0073] Step (2) respectively concentrating the alcohol extract and the water extract to obtain an extract with a relative density of 1.30 (60° C.), mixing the extracts, drying and pulverizing to obtain a dry paste powder (with a water content of 6%);

[0074] Step (3): adding disintegrant sodium carboxymethyl starch (CMS-Na) to the dry paste powder, with the total amount being 1% of the mass of the dry paste powder prepared in step (2), and mixing well to obtain a mixture.

[0075] Step (4): Add 70% ethanol to the mixture obtained in step (3) to prepare micro-pills, wherein the amount of ethanol used is 0.2 times of the mixture. The micro-pills are dried at 65° C. to obtain the Qi-invigorating, blood-activating and knot-dispersing medicinal composition pills.

[0076] Example 9

[0077] According to the formula of the Chinese medicine composition of Example 1, capsules are prepared according to the following steps:

[0078] Step (1):

[0079] Step (1.1): weigh each herb according to the above-mentioned formula, dry and crush them respectively, and mix them evenly to obtain a mixed material;

[0080] Step (1.2): adding 65% ethanol by volume to the mixed material for reflux extraction, wherein the amount of ethanol added is 8 times the mass of the mixed material, the extraction time is 1 hour, and the extraction is repeated twice, using an equal amount of ethanol each time, and filtering to obtain a filtrate and a medicinal residue;

[0081] Step (1.3): recovering ethanol from the filtrate under reduced pressure to obtain an ethanol extract; then adding water to the medicinal residue for extraction once, with the mass ratio of medicinal residue to water being 1:10, and the extraction time being 1 hour, to obtain a water extract;

[0082] Step (2) respectively concentrating the alcohol extract and the water extract to obtain an extract with a relative density of 1.30 (60° C.), mixing the extracts, drying and pulverizing to obtain a dry paste powder (with a water content of 6%);

[0083] Step (3): adding auxiliary materials to the dry paste powder, the auxiliary materials including starch, lactose and microcrystalline cellulose; the mass ratio of the dry paste powder, starch, lactose and microcrystalline cellulose is 1:0.2:0.2:0.2, mixing well to obtain a mixture.

[0084] Step (4): add 70% ethanol to the mixture to obtain wet granules, dry (at 65°C) to obtain dry granules, add lubricant silicon dioxide in an amount of 1% of the dry granules, mix thoroughly, and fill into hollow capsule shells, 0.6 g per capsule, polish, and package to obtain the Qi-invigorating, blood-activating, and knot-dispersing pharmaceutical composition capsules.

[0085] Application Example 1 Clinical observation of the pharmaceutical composition of the present invention in patients with pulmonary nodules of qi deficiency and blood stasis type

[0086] 1. Materials and methods

[0087] 1.1 Clinical Data

[0088] A total of 200 patients with benign pulmonary nodules of qi deficiency and blood stasis type detected in the Dongchuan District Traditional Chinese Medicine Hospital of Kunming from September 2020 to June 2023 were included in the research subjects. A double-blind design was adopted, and the patients were divided into two groups according to the random number table method, with 100 cases in each group.

[0089] Finally, 184 valid cases were collected. Among the valid cases, 86 cases were in the control group, including 28 males and 58 females, aged 38-66 years old, with an average age of 53.06±6.83 years old; body mass index (BMI) 18.68~24.85kg / m 2 , average (22.18±1.38)kg / m 2 ; The average diameter of lung nodules (mm) was 6.56±0.42; Among the types of lung nodules detected, there were 92 solid nodules and 105 ground glass nodules.

[0090] There were 98 cases in the treatment group, including 31 males and 67 females, aged 33-69 years old, with an average age of 51.68±7.54 years old; body mass index (BMI) 19.16~25.29kg / m 2 , average (22.36±1.27)kg / m 2 ; The average diameter of pulmonary nodules (mm) was 6.49±0.38; Among the types of pulmonary nodules detected, there were 106 solid nodules and 104 ground glass nodules. There was no significant difference in general data between the two groups (P>0.05), as shown in Table 1:

[0091] Table 1 Comparison of baseline data between the two groups of patients

[0092]

[0093] 1.2 Diagnostic criteria

[0094] (1) Pulmonary nodules meet the relevant diagnostic criteria in the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)", and the diagnosis is confirmed by physical examination and chest CT examination;

[0095] (2) TCM syndrome differentiation: Refer to the "Guidelines for Clinical Research of New Chinese Medicines", "Standards for Diagnosis and Efficacy of TCM Diseases" and TCM diagnosis, and TCM syndrome differentiation belongs to the Qi deficiency and blood stasis type. Main symptoms: cough, expectoration, chest and flank pain; secondary symptoms: fatigue, spontaneous sweating, poor appetite, hemoptysis or blood in sputum; tongue and pulse: dark purple tongue or ecchymosis, thickened sublingual veins, thin white or greasy tongue coating, tooth marks, thin or astringent pulse. Anyone who meets 2 or more main symptoms and 1 or more secondary symptoms; or meets 1 or more main symptoms and 2 or more secondary symptoms, combined with tongue and pulse, can be diagnosed as Qi deficiency and blood stasis syndrome.

[0096] 1.3 Inclusion criteria

[0097] (1) Meet the diagnostic criteria;

[0098] (2) In the first case of the disease, CT examination showed that the pulmonary nodules were solid or benign nodules with ground-glass opacities in the lungs, 0.5 cm ≤ diameter ≤ 1.0 cm;

[0099] (3) 18 years old ≤ ≤ 85 years old;

[0100] (4) The patient is conscious, compliant, and able to cooperate with the trial.

[0101] 1.4 Exclusion criteria

[0102] (1) Alcoholism and / or psychoactive substance or drug abusers and addicts;

[0103] (2) Patients with severe primary diseases;

[0104] (3) Combined with malignant tumors or systemic infectious diseases;

[0105] (4) Intolerance or allergy to the study drug;

[0106] (5) Pulmonary nodules are diffuse in the lungs (the number of pulmonary nodules is more than 10).

[0107] 1.5 Elimination criteria

[0108] (1) Those who have poor compliance during the trial, fail to take medication according to regulations, or violate the trial protocol, thus affecting the judgment of drug efficacy;

[0109] (2) Unwilling to continue the clinical trial or voluntarily withdraw from the clinical trial.

[0110] 1.6 Grouping and treatment methods

[0111] Control group: No Chinese or Western medicine treatment was given, and patients were hospitalized for reexamination at 3 and 6 months of follow-up, with a focus on observing the patients' clinical symptoms and detecting changes in the size of lung nodules.

[0112] Treatment group: Orally take the drug combination capsules for dispersing nodules prepared in Example 9 of the present invention, 5 capsules each time, three times a day, half an hour after meals.

[0113] 1.7 Treatment duration and follow-up period

[0114] The treatment lasted for 6 months. The two groups of patients were followed up at the time of consultation, 3 months after treatment, and 6 months after treatment to evaluate the TCM syndrome scores, changes in lung nodule size, and tumor marker levels before and after medication.

[0115] 1.8 Evaluation Indicators

[0116] 1.8.1 TCM Syndrome Score

[0117] According to the TCM syndrome standard evaluation of the "Guidelines for Clinical Research of New Chinese Medicines", the TCM syndrome score is determined by the patient's main symptoms, secondary symptoms, tongue and pulse. The main symptoms and secondary symptoms are scored 6, 4, 2, 0 points and 3, 2, 1, 0 points respectively according to the severity of the patient's clinical symptoms (severe, moderate, mild, none). The tongue and pulse score is 0 points for normal and 1 point for abnormal. The total score of the patient's TCM syndrome score ranges from 0 to 37 points. The higher the TCM syndrome score, the more severe the patient's clinical symptoms.

[0118] TCM syndrome score: quantitative scoring of symptoms.

[0119] Main symptoms:

[0120] ① Cough: no symptoms (none: 0 points); intermittent cough during the day, not affecting daily life and work (mild: 2 points); cough during the day or occasionally at night, but still able to go to work (moderate: 4 points); frequent cough or paroxysmal cough during the day and night, affecting work and rest (severe: 6 points).

[0121] ②Expectoration: no symptoms (none: 0 points); expectoration of 10-50 ml day and night (mild: 2 points); expectoration of 50-100 ml day and night (moderate: 4 points); expectoration of more than 100 ml day and night (severe: 6 points).

[0122] ③ Chest and flank pain: no symptoms (none: 0 points); mild pain, no impact on life, and can be relieved on its own (mild: 2 points); mild pain, prolonged pain, and need painkillers to relieve (moderate: 4 points); frequent pain attacks, prolonged pain, and need painkillers to relieve (severe: 6 points).

[0123] Secondary symptoms:

[0124] ① Fatigue: no symptoms (none: 0 points); obvious fatigue and lack of energy after activities (mild: 1 point); feeling fatigue and mental fatigue as soon as moving (moderate: 2 points); feeling obvious fatigue and mental fatigue even when resting (severe: 3 points).

[0125] ② Spontaneous sweating: no symptoms (none: 0 points); excessive sweating after extensive activity (mild: 1 point); sweating after a little activity (moderate: 2 points); excessive sweating, even without moving (severe: 3 points).

[0126] ③ Poor appetite: no symptoms (none: 0 points); boring eating every day, and the amount of food eaten remains unchanged (mild: 1 point); poor appetite, and the amount of food eaten is reduced by about 1 / 3 (moderate: 2 points); aversion to eating, and the amount of food eaten is reduced by 1 / 2 (severe: 3 points).

[0127] ④ Coughing up blood or blood in sputum: no symptoms (none: 0 points); blood in sputum (mild: 1 point); blood in sputum (moderate: 2 points); frequent hemoptysis (severe: 3 points).

[0128] 1.8.2 Changes in the size of pulmonary nodules: ① Complete disappearance: the target lesion disappears and lasts for at least 4 weeks; ② Partial reduction: the maximum diameter of the baseline lesion decreases by at least 30% and lasts for at least 4 weeks; ③ Progression of lesions: the maximum diameter of the baseline lesion increases by at least 20%; ④ Stable lesions: the change in the maximum diameter of the baseline lesion is between partial reduction and progression of lesions. Pulmonary nodule reduction rate = (number of completely disappeared lesions + number of partially reduced lesions) / total number of pulmonary nodules × 100%.

[0129] 1.8.3 Tumor markers: 3 ml of fasting peripheral cubital venous blood was collected at the time of consultation, 3 months and 6 months of follow-up, and the blood was centrifuged (3500 r / min, centrifugal radius 10 cm, centrifugation for 15 min) to obtain serum. Carcinoembryonic antigen (CEA) and cytokeratin 19 fragment antigen 21-1 (CYFRA21-1) were measured using an automatic biochemical analyzer. The specific operations followed the equipment instructions and standard operating procedures.

[0130] 1.8.4 Medication safety: Patients in the treatment group underwent routine blood and urine tests as well as liver and kidney function tests at the time of consultation and at the end of the study. If patients had serious adverse reactions during treatment, they were treated promptly.

[0131] 1.9 Statistical methods

[0132] SPSS 25.0 statistical software was used to analyze the research data. The t test was used for counting data, [n(%)] for binary data or sample composition ratio data, and χ 2 Test, rank-sum test was used for rank data, and P < 0.05 was considered statistically significant.

[0133] 2. Results

[0134] 2.1 Comparison of TCM syndrome scores between the two groups of patients

[0135] At 3 and 6 months of follow-up, the TCM syndrome scores of both groups were lower than those at the time of consultation, and the score in the treatment group was lower than that in the control group (P<0.05). At 6 months of follow-up, the TCM syndrome scores of both groups were lower than those at 3 months, and the score in the treatment group was lower than that in the control group (P<0.05), see Table 2.

[0136] Table 2 Comparison of TCM syndrome scores between the two groups point]

[0137]

[0138] Note: Compared with the same group at the time of treatment, ◇ P<0.05; compared with the same group at 3 months follow-up, ● P<0.05.

[0139] 2.2 Comparison of changes in the size of pulmonary nodules between the two groups of patients

[0140] At 3 and 6 months of follow-up, the lung nodule reduction rate in the treatment group was higher than that in the control group, and the overall proportion of disappeared and reduced lung nodules was higher than that in the control group (P<0.05), as shown in Tables 3 and 4.

[0141] Table 3 Comparison of changes in size and number of pulmonary nodules between the two groups at 3-month follow-up [n (%)]

[0142]

[0143]

[0144] Table 4 Comparison of changes in the size of pulmonary nodules between the two groups at 6 months of follow-up [n (%)]

[0145]

[0146] 2.3 Comparison of tumor marker levels between the two groups

[0147] At 3 and 6 months of follow-up, the serum CEA and CYFRA21-1 levels in the treatment group were lower than those at the time of consultation, and the treatment group was lower than the control group (P<0.05). At 6 months of follow-up, the serum CEA levels of both groups were lower than those at 3 months, and the treatment group was lower than the control group (P<0.05); while the serum CYFRA21-1 level in the control group was not significantly different from that at 3 months (P>0.05), and that in the treatment group was lower than that at 3 months, which was statistically significant (P<0.05), and the treatment group was lower than the control group (P<0.05) (see Tables 5 and 6).

[0148] Table 5 Comparison of serum CEA levels between the two groups ng / ml]

[0149]

[0150] Note: Compared with the same group at the time of treatment, ◇ P<0.05; compared with the same group at 3 months follow-up, ● P<0.05.

[0151] Table 6 Comparison of serum CYFRA21-1 levels between the two groups ng / ml]

[0152]

[0153] Note: Compared with the same group at the time of treatment, ◇ P<0.05; compared with the same group at 3 months follow-up, ● P<0.05.

[0154] 2.4 Medication safety

[0155] During the treatment, the blood and urine routine tests as well as liver and kidney function indicators of the patients in the treatment group were within the normal range, and no adverse reactions were observed during the treatment.

[0156] 3. Conclusion

[0157] The pharmaceutical composition of the present invention has good clinical efficacy in treating patients with qi deficiency and blood stasis type pulmonary nodules, can effectively reduce the TCM syndrome score of patients, improve the pulmonary nodule reduction rate, and reduce the level of tumor markers. It has high safety in clinical use.

[0158] Application Example 2 Clinical observation of the pharmaceutical composition of the present invention in patients with sub-centimeter pulmonary nodules of Qi deficiency and blood stasis type

[0159] 1. Materials and methods

[0160] 1.1 Clinical Data

[0161] A total of 72 patients with sub-centimeter pulmonary nodules of Qi deficiency and blood stasis type who were admitted to the Traditional Chinese Medicine Hospital of Dongchuan District, Kunming from June 2022 to June 2023 were included in the study and divided into a treatment group and a control group, with 36 cases in each group. Both groups of patients signed informed consent and voluntarily participated in this study. The research plan was approved by the Medical Ethics Committee of the hospital. The subjects were grouped using a single-blind method. At the end of the study, 2 patients in the control group voluntarily withdrew from the study during the study period and 2 were lost to follow-up. There were 36 final effective cases in the treatment group and 32 final effective cases in the control group. There was no statistically significant difference in the baseline data of the two groups of patients (P>0.05). See Table 6 for details.

[0162] Table 6 Comparison of baseline data between the two groups of patients

[0163]

[0164] 1.2 Case selection criteria

[0165] 1.2.1 Diagnostic criteria

[0166] (1) Western medicine diagnostic criteria: Refer to the diagnostic criteria for pulmonary nodules in the Fleischner Society and the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)": Focal lesions in the lungs, imaging manifestations of single or multiple shadows with a diameter of ≤3 cm and nearly round and increased density, which are divided into solid and subsolid nodules according to density. Subsolid nodules include ground glass nodules and mixed nodules. Subcentimeter pulmonary nodules refer to pulmonary nodules with a diameter of ≤1 cm.

[0167] (2) TCM diagnostic criteria: With reference to the relevant contents of the "TCM Diagnosis and Efficacy Criteria for Diseases and Symptoms" and the "Guidelines for Clinical Research of New Chinese Medicines", combined with the patient's clinical symptoms, the TCM diagnostic criteria for patients with qi deficiency and blood stasis type pulmonary nodules are formulated: ① Patients with pulmonary nodules may have symptoms such as cough, sputum, chest tightness, chest pain, shortness of breath, etc., but there may also be no clinical manifestations. ② Symptoms of qi deficiency and blood stasis syndrome: fatigue, spontaneous sweating, poor appetite, hemoptysis or blood in sputum. For patients who have imaging support for the diagnosis of pulmonary nodules and meet ≥ 3 of the above symptoms of qi deficiency and blood stasis syndrome, with or without the first symptom, the diagnosis can be made in combination with tongue and pulse. Tongue and pulse: dark tongue, or with ecchymosis, thickened sublingual collaterals, thin white or greasy tongue coating, tooth marks, thin or astringent pulse.

[0168] 1.2.2 Inclusion criteria:

[0169] (1) Those who meet the above-mentioned Chinese and Western medical diagnostic criteria.

[0170] (2) A single pulmonary nodule with a diameter of ≤1 cm; or multiple pulmonary nodules with the largest one with a diameter of ≤1 cm and the number of pulmonary nodules ≤5.

[0171] (3) Patients who have no surgical indications after comprehensive assessment and are recommended to have regular follow-up; or patients who have surgical indications but refuse surgery and require regular follow-up.

[0172] (4) Aged 30 to 70 years old; regardless of gender, and the patient or family member consents to participate in the clinical trial.

[0173] 1.2.3 Exclusion criteria

[0174] (1) Those who do not meet the diagnostic criteria and / or inclusion criteria of Western medicine and traditional Chinese medicine.

[0175] (2) Patients whose nodules are likely to be malignant after comprehensive assessment and who are recommended by the clinic to undergo surgical treatment and / or related follow-up treatment in the near future.

[0176] (3) Patients with major chronic respiratory diseases (such as chronic obstructive pulmonary disease, bronchopulmonary tumors, bronchial asthma, silicosis, idiopathic pulmonary fibrosis, etc.).

[0177] (4) Patients with serious diseases of the cardiovascular, cerebrovascular, liver, kidney and blood systems, as well as mental illness.

[0178] (5) Patients who had used inhaled, oral or intravenous medications containing glucocorticoids within 6 months prior to enrollment.

[0179] (6) Women who are pregnant or breastfeeding, or those who are allergic to related drugs.

[0180] 1.2.4 Exit criteria

[0181] Cases in which drug treatment was suspended or terminated during the treatment process or lost to follow-up during the study period were considered as withdrawal cases.

[0182] 1.3 Treatment methods

[0183] Treatment group: The pills prepared by the method described in Example 8 were administered orally half an hour after meals, twice a day, 1 bag each time, each bag containing 8 g.

[0184] Control group: those who refused to take medication and were only willing to be followed up.

[0185] Patients in both groups were followed up at the time of enrollment and 3 months after enrollment.

[0186] 1.4 Observation indicators

[0187] 1.4.1 Diameter of a single pulmonary nodule or the largest diameter of multiple pulmonary nodules: The diameters of pulmonary nodules in the lung CT examinations of the two groups of patients were compared before treatment and at the end of 3 months of treatment.

[0188] 1.4.2 Pulmonary function indicators: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and the ratio of forced expiratory volume in one second to forced vital capacity (FEV1 / FVC%) were tested and compared between the two groups of patients before treatment and at the end of 3 months of treatment.

[0189] 1.4.3 Immune inflammation indexes: Before treatment and at the end of 3 months of treatment, fasting peripheral venous blood samples were collected from the two groups of patients: serum tumor necrosis factor-α (TNF)-α, interleukin (IL)-1β, IL-6, and IL-10 levels were detected by enzyme-linked immunosorbent assay; serum immunoglobulin (Ig) G, IgA, and IgM levels were detected by immunoturbidimetry; peripheral blood CD4 + T lymphocyte ratio, CD8+T lymphocyte ratio, CD4 + / CD8 + The T lymphocyte ratio was tested.

[0190] 1.4.4 Medication safety: Patients in the treatment group underwent routine blood and urine tests as well as liver and kidney function tests at the time of consultation and at the end of the study. If patients had serious adverse reactions during treatment, they were treated promptly.

[0191] 1.5 Statistical methods

[0192] SPSS22.0 was used to analyze the data. Normal distribution data were expressed as (x±s), and non-normal distribution data were expressed as Median (P25, P75). The Kolmogorov-Smirnov method was used to test whether the variables obeyed the normal distribution. The paired sample t test was used for intra-group comparison, and the two independent sample t test was used for inter-group comparison. The Wilcoxon test was used for intra-group comparison of non-normal distribution data, and the Mann-Whitney U test was used for inter-group comparison. The count data were expressed as n (%) and the chi-square test was used. 2 P < 0.05 was considered statistically significant.

[0193] 2. Results

[0194] 2.1 Comparison of lung nodule diameters between the two groups before and after treatment

[0195] Before treatment, there was no significant difference in the diameter of lung nodules between the two groups (P>0.05). After 3 months of treatment, the diameter of lung nodules in the treatment group was reduced compared with that before treatment, with a significant difference (P<0.05); while there was no significant difference in the diameter of lung nodules in the control group compared with that before treatment (P>0.05); and the diameter of lung nodules in the treatment group was significantly lower than that in the control group (P<0.05). See Table 7 for details.

[0196] Table 7 Comparison of lung nodule diameters between the two groups of patients before and after treatment ( mm)

[0197]

[0198] 2.2 Comparison of lung function indicators between the two groups before and after treatment

[0199] Before treatment, there was no significant difference in the lung function indexes between the treatment group and the control group (P>0.05). After 3 months of treatment, there was no significant difference in the lung function indexes of the control group compared with those before treatment (P>0.05); the lung function indexes of the treatment group were higher after treatment than before treatment, with significant difference (P<0.05), and the treatment group was significantly higher than the control group, with significant difference (P<0.05). See Table 8 for details.

[0200] Table 8 Comparison of lung function between the two groups of patients before and after treatment

[0201]

[0202] 2.3 Comparison of immune and inflammatory indicators between the two groups of patients before and after treatment

[0203] Before treatment, there were no significant differences in immune inflammation indexes between the treatment group and the control group (P>0.05). After 3 months of treatment, there were no significant differences in immune inflammation indexes between the control group and before treatment (P>0.05); serum IL-10, IgG, IgA, IgM levels, peripheral blood CD4+T lymphocyte ratio, CD4+ / CD8+T lymphocyte ratio in the treatment group were higher than those before treatment, serum TNF-α, IL-1β, IL-6 levels and peripheral blood CD8+T lymphocyte ratio were lower than those before treatment, with significant differences (P<0.05); and serum IL-10, IgG, IgA, IgM levels, peripheral blood CD4+T lymphocyte ratio, CD4+ / CD8+T lymphocyte ratio in the treatment group were significantly higher than those in the control group, serum TNF-α, IL-1β, IL-6 levels and peripheral blood CD8+T lymphocyte ratio were significantly lower than those in the control group, with significant differences (P<0.05). See Table 9 for details.

[0204] Table 9 Comparison of immune and inflammatory indicators between the two groups of patients before and after treatment

[0205]

[0206] 2.4 Medication safety

[0207] During the treatment, the blood and urine routine tests as well as liver and kidney function indicators of the patients in the treatment group were within the normal range, and no adverse reactions were observed during the treatment.

[0208] 3. Conclusion: The pharmaceutical composition described in Example 1 is applied to the treatment of patients with sub-centimeter pulmonary nodules of Qi deficiency and blood stasis type, which can reduce pulmonary nodules, alleviate inflammatory response, improve immune imbalance, and enhance lung function.

[0209] The specific implementation methods of the present application are expressed, and the description is relatively specific and detailed, but it cannot be regarded as

[0210] It should be understood as limiting the protection scope of this application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the technical solution concept of this application, which all belong to the protection scope of this application.

Claims

1. A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation, characterized in that: The composition is calculated by weight: 10-30 parts of Codonopsis pilosula, 5-20 parts of Tripterygium wilfordii, 10-20 parts of Small Red Ginseng, 5-15 parts of Black Heart Ginger and 5-15 parts of Wanzhangshen.

2. A medicinal composition for invigorating qi, promoting blood circulation and dispersing stagnation according to claim 1, characterized in that: The composition is calculated by weight: 12-28 parts of Codonopsis pilosula, 7-18 parts of Tripterygium wilfordii, 12-18 parts of Small Red Ginseng, 7-18 parts of Black Heart Ginger and 7-18 parts of Wanzhangshen.

3. A medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules according to claim 2, characterized in that: The composition is calculated by weight: 15-25 parts of Codonopsis pilosula, 8-16 parts of Tripterygium wilfordii, 13-18 parts of Small Red Ginseng, 10-15 parts of Black Heart Ginger and 10-15 parts of Wanzhangshen.

4. A pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing stagnation, characterized in that: The invention comprises an alcohol extract and a water extract of a medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules as claimed in any one of claims 1 to 3 and pharmaceutically acceptable excipients required for the preparation.

5. The pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing nodules according to claim 4, characterized in that: The preparation is in the form of capsules or pills.

6. The pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing nodules according to claim 5, characterized in that: The capsule is prepared by the following preparation method: Step (1): extracting with ethanol to obtain an alcohol extract of a medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules, and adding water to the medicinal residue after the alcohol extraction to obtain a water extract; Step (2): the alcohol extract and the water extract are concentrated and then mixed, and dried and crushed to obtain a dry paste powder; Step (3): adding auxiliary materials to the dry paste powder prepared in step (2), and mixing to obtain a mixture; Step (4): add 60%-80% ethanol to the mixture to obtain wet granules, dry at 55-75°C to obtain dry granules, add a lubricant, mix thoroughly, and then fill into hollow capsule shells to obtain capsules of the medicinal composition for invigorating qi, activating blood circulation and dispersing knots.

7. The pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing stagnation according to claim 6, characterized in that: The auxiliary materials described in step (3) include starch, lactose and microcrystalline cellulose, and the mass ratio of dry powder, starch, lactose and microcrystalline cellulose is: 1: 0.1-0.2: 0.1-0.2: 0.1-0.2; the lubricant described in step (4) is selected from at least one of silicon dioxide and magnesium stearate, and the total amount is 0.6%-1% of the dry particles.

8. The pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing nodules according to claim 5, characterized in that: The pills are made by the following preparation method: Step (1): extracting with ethanol to obtain an alcohol extract of a medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules, and adding water to the medicinal residue after the alcohol extraction to obtain a water extract; Step (2): the alcohol extract and the water extract are concentrated and then mixed, and dried and crushed to obtain a dry paste powder; Step (3): adding a disintegrant to the dry paste powder prepared in step (2), and mixing to obtain a mixture; Step (4): adding 60%-80% ethanol to the mixture prepared in step (3) to prepare micropills, and drying to obtain pills of the medicinal composition for invigorating qi, activating blood circulation and dispersing nodules.

9. Use of a medicinal composition for invigorating qi, promoting blood circulation and dispersing nodules as claimed in any one of claims 1 to 3 in the preparation of a medicament for treating pulmonary nodules of qi deficiency and blood stasis type.

10. Use of the pharmaceutical composition preparation for invigorating qi, promoting blood circulation and dispersing nodules as claimed in any one of claims 5 to 8 in the preparation of a medicine for treating pulmonary nodules of qi deficiency and blood stasis type.

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