A Chinese medicine composition for treating early chronic obstructive pulmonary disease and its application

Abstract

The invention discloses a Chinese medicine composition for treating early chronic obstructive pulmonary disease and its application, which belongs to the technical field of traditional Chinese medicine, and comprises the following raw materials by weight: 8-25 parts of astragalus, 8-25 parts of Pseudostellariae Radix, 5-20 parts of Pinellia ternata, 5-20 parts of Coltsfoot Flos, 5-20 parts of Perilla Fructus, 5-20 parts of Angelicae Sinensis, 5-20 parts of Peucedanum, 5-20 parts of Radix Ophiopogonis, and 5-20 parts of Radix Scutellariae. The beneficial effects of the invention are: while strengthening the spleen and lungs, resolving phlegm and relieving asthma, it focuses on harmonizing qi and blood, clearing heat and moistening the lungs, plays the role of strengthening the foundation, eliminating evil, and treating the symptoms at the same time, has the effects of replenishing ancestral qi, soothing the lungs and relieving cough, moistening the lungs and resolving phlegm, and taking into account the effects of promoting blood circulation and relieving asthma, can improve the cough and sputum symptoms of patients with early chronic obstructive pulmonary disease, reduce CAT scores, reduce the risk of acute exacerbation, improve exercise endurance and quality of life, and can effectively treat early chronic obstructive pulmonary disease.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating early chronic obstructive pulmonary disease and application thereof. Background Art

[0002] Chronic obstructive pulmonary disease, referred to as "COPD", is the third leading cause of death from human diseases, with high morbidity, high disability rate and high mortality rate. With the aging of the population, the socioeconomic burden of COPD is increasing, and the prevention and control situation is becoming increasingly severe. Early COPD refers to people whose COPD severity is classified as mild or moderate. Studies have shown that early COPD is the main body of COPD, accounting for about 92.7% of the total number of patients. The lung function of this group of people is in a rapid decline period, and the annual decline rate of FEV1 is 49-60mL / year. However, the symptoms of patients are relatively mild and the disease is hidden. When patients go to the doctor after symptoms such as shortness of breath and dyspnea, the best treatment period has been lost. Therefore, it is a key link in the prevention and control of COPD to move the prevention and control of COPD forward, achieve early diagnosis and treatment, delay the progression of the disease, and then reduce the disability rate and mortality rate.

[0003] In the prior art, non-drug means for treating early COPD include smoking cessation, vaccination, pulmonary rehabilitation, and maintaining nutritional status. Among them, smoking cessation can slow down the decline of lung function and improve survival rate, and pulmonary rehabilitation has been proven to improve symptoms and exercise tolerance. However, there are pain points and difficulties in the promotion and application of non-drug treatments. For example, smoking cessation is affected by a variety of complex factors such as physiology, psychology, and society, and the treatment effect is unsatisfactory. Pulmonary rehabilitation is often limited by venues and equipment, making it difficult to promote and apply. At the same time, drug treatment for early COPD is very limited. After receiving treatment, most patients with early COPD still have 36.6% of patients with mMRC scores ≥ 2 points and 76.4% of patients with CAT scores ≥ 10 points. Most of the existing Chinese patent medicines for the treatment of early COPD are preparations for the treatment of colds, coughs, and sputum. These drugs cannot take into account the effects of replenishing Zongqi, resolving phlegm and activating blood circulation at the same time, and are not completely symptomatic for the treatment of early COPD. Therefore, it is crucial to develop a Chinese medicine composition that mainly replenishes Zongqi and has the effects of resolving phlegm and activating blood circulation to treat early COPD. Summary of the invention

[0004] In order to solve the problem that most patients with early COPD still have symptoms after treatment and that existing Chinese medicines are not completely effective in treating early COPD, the inventors have verified through clinical research a Chinese medicine composition that can treat early COPD by replenishing the vital energy, resolving phlegm and activating blood circulation.

[0005] The first aspect of the present invention provides a traditional Chinese medicine composition for treating early chronic obstructive pulmonary disease, which comprises the following raw materials, by weight: 8-25 parts of astragalus, 8-25 parts of pseudoginseng, 5-20 parts of pinellia, 5-20 parts of coltsfoot, 5-20 parts of perilla, 5-20 parts of angelica, 5-20 parts of peucedanum, 5-20 parts of ophiopogon, and 5-20 parts of scutellaria.

[0006] As a preferred embodiment, the following raw materials are included by weight: 10-20 parts of astragalus, 10-20 parts of Pseudostellariae Radix, 8-15 parts of Pinellia ternata, 8-15 parts of Coltsfoot Flos, 8-15 parts of Perilla Seed, 8-15 parts of Angelica sinensis, 8-15 parts of Peucedanum peucedanum, 8-15 parts of Ophiopogon japonicus, and 8-15 parts of Scutellaria baicalensis.

[0007] As a preferred embodiment, the following raw materials are included by weight: 15 parts of astragalus, 15 parts of Pseudostellariae Radix, 10 parts of Pinellia ternata, 10 parts of Coltsfoot Flos, 10 parts of Perilla Fructus, 10 parts of Angelica Sinensis, 10 parts of Peucedanum peucedanum, 10 parts of Ophiopogon japonicus, and 10 parts of Scutellaria baicalensis.

[0008] The second aspect of the present invention provides use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating early chronic obstructive pulmonary disease.

[0009] The third aspect of the present invention provides a medicine for treating early chronic obstructive pulmonary disease, comprising the above-mentioned Chinese medicine composition for treating early chronic obstructive pulmonary disease and pharmaceutically acceptable excipients.

[0010] In some more preferred embodiments, the dosage form of the drug includes one or more of the following: granules, decoctions, pastes, pills, capsules, tablets, mixtures, suspensions, pastes, drops, powders or oral solutions.

[0011] The fourth aspect of the present invention provides a method for preparing the drug as a Chinese medicine decoction as follows:

[0012] Step 1, mix all the raw materials according to weight proportion, add purified water and soak;

[0013] Step 2: extract the raw material twice, filter and concentrate to obtain.

[0014] In some more preferred embodiments, in step 1, 6-7 times the amount of water is added to soak the API;

[0015] The extraction process in step 2 includes: collecting and filtering the medicinal solution after the first decoction for 2-4 hours, adding 5-6 times the amount of water of the total raw materials for the second decoction and decoct for 1-2 hours, collecting and filtering the medicinal solution, and combining the two extraction filtrates.

[0016] In some of the more preferred embodiments, the crude drug substance powder in the step 2 is extracted using a high-efficiency high-pressure continuous extraction technology, the mobile phase is pure water, and the extraction is performed twice continuously at 10-40°C with a high pressure difference of 0.1-35MPa and a time of 0.2-0.4 seconds, and the two extraction filtrates are combined.

[0017] In some of the more preferred embodiments, the extract in step 2 needs to be filtered twice, first with a 200-mesh fiber filter and then with a 500 nm ceramic membrane filter.

[0018] This prescription is mainly used to replenish vital energy and also to resolve phlegm and promote blood circulation to treat early COPD. Among them, Astragalus has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid and nourishing blood, removing stagnation and relieving numbness, expelling toxins and discharging pus, and astringing sores and promoting tissue regeneration. Pseudostellaria has the effects of replenishing qi and strengthening the spleen, promoting fluid and moistening the lungs. Pinellia has the effects of drying dampness and resolving phlegm. Coltsfoot Flos has the effects of moistening the lungs and lowering qi, relieving cough and resolving phlegm. Perilla Seed has the effects of descending qi and resolving phlegm, relieving cough and relieving asthma. Peucedanum has the effects of descending qi and resolving phlegm, dispersing wind and clearing heat. Angelica has the effects of replenishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. Ophiopogon has the effects of nourishing yin and promoting fluid, moistening the lungs and clearing the heart. Scutellaria baicalensis has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. The above components work together to replenish vital energy, soothe the lungs and relieve cough, moisten the lungs and resolve phlegm, while also taking into account the effects of promoting blood circulation and relieving asthma, reducing the number of acute exacerbations of patients, improving clinical symptoms and lung function, and can effectively treat early chronic obstructive pulmonary disease.

[0019] The beneficial effects produced by the technical solution of the present invention are as follows:

[0020] The present invention provides a traditional Chinese medicine composition for treating early-stage chronic obstructive pulmonary disease. The prescription focuses on harmonizing qi and blood, clearing away heat and moistening the lungs while strengthening the spleen and lungs, resolving phlegm and relieving asthma, playing the role of strengthening the foundation, eliminating evil, and treating both the symptoms and the root causes. The prescription has the effects of replenishing ancestral qi, soothing the lungs and relieving cough, moistening the lungs and resolving phlegm, while taking into account the effects of promoting blood circulation and relieving asthma. The prescription can improve the cough and sputum symptoms of patients with early-stage chronic obstructive pulmonary disease, reduce CAT scores, reduce the risk of acute exacerbation, improve exercise endurance and quality of life, and has good safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 This is a comparison chart of the improvement of cough symptom scores at each visit point in the treatment group of the present invention and the control group compared with before treatment;

[0023] Figure 2 is a comparison chart of the expectoration symptom scores at each visit point between the treatment group of the present invention and the control group;

[0024] Figure 3 This is a comparison chart of the improvement of CAT scores at each visit point in the treatment group and the control group compared with before treatment;

[0025] Figure 4 This is a comparison chart of the improvement degree of 6MWT distance at each visit point between the treatment group of the present invention and the control group compared with before treatment. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention is clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments. Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] The inventor has obtained a Chinese medicine composition for treating early chronic obstructive pulmonary disease and its application through clinical research and verification, which is widely applicable to the treatment of early chronic obstructive pulmonary disease, can improve exercise endurance and physical fitness, and has a certain therapeutic effect especially in the early stage of chronic obstructive pulmonary disease. The specific implementation method is as follows:

[0028] The first aspect of the present invention provides a traditional Chinese medicine composition for treating early chronic obstructive pulmonary disease, which comprises the following raw materials, by weight: 8-25 parts of astragalus, 8-25 parts of pseudoginseng, 5-20 parts of pinellia, 5-20 parts of coltsfoot, 5-20 parts of perilla, 5-20 parts of angelica, 5-20 parts of peucedanum, 5-20 parts of ophiopogon, and 5-20 parts of scutellaria.

[0029] The core pathogenesis of early COPD is "lung and spleen deficiency, phlegm and turbidity blocking the lungs". Different from conventional lung-tonifying, spleen-strengthening and phlegm-removing prescriptions, the Chinese medicine composition in the present invention has been scientifically designed in terms of drug composition and proportion. It not only replenishes the ancestral qi, relieves the lungs and relieves cough, but also focuses on promoting blood circulation and relieving asthma, playing the role of strengthening the foundation and eliminating evil, and treating both the symptoms and the root. Among them, Astragalus and Pseudostellariae Radix are the most used drugs in this prescription, playing the role of monarch drugs, strengthening the function of strengthening the spleen and lungs, and supporting the ancestral qi. The proportions of various phlegm-removing and cough-relieving medicinal materials are relatively balanced, ensuring the synergy of multiple effects. The four flavors of Pinellia ternata, Coltsfoot Flos, Perilla Fructus, and Peucedanum chinense are used as ministerial drugs, which play the role of drying dampness and strengthening the spleen, lowering qi and relieving asthma, relieving cough and removing phlegm, and further strengthening the function of Astragalus and Pseudostellariae Radix to move the spleen. This prescription also uses Angelica sinensis to moisten dryness and activate blood circulation, harmonize qi and blood, Ophiopogon japonicus and Scutellariae Radix to clear heat and moisten the lungs, and alleviate the warm dryness of other drugs.

[0030] A traditional Chinese medicine composition for treating early chronic obstructive pulmonary disease, wherein the optimal formula ratio is 10-20 parts by weight: 10-20 parts of astragalus, 10-20 parts of pseudoginseng, 8-15 parts of pinellia, 8-15 parts of coltsfoot, 8-15 parts of perilla, 8-15 parts of angelica, 8-15 parts of peucedanum, 8-15 parts of ophiopogon, and 8-15 parts of scutellaria.

[0031] A traditional Chinese medicine composition for treating early chronic obstructive pulmonary disease, wherein the optimal formula ratio is 15 parts by weight: 15 parts of astragalus, 15 parts of pseudostellaria, 10 parts of pinellia, 10 parts of coltsfoot flower, 10 parts of perilla seed, 10 parts of angelica, 10 parts of peucedanum, 10 parts of ophiopogon, and 10 parts of scutellaria.

[0032] Early COPD patients have mild symptoms such as cough, sputum, and shortness of breath, and the disease is still shallow. The pathogenesis is mostly lung and spleen deficiency. At the same time, due to dysfunction of spleen and stomach transportation and abnormal distribution of body fluids, sputum, dampness, and blood stasis are produced, which further leads to aggravation of cough, sputum, and wheezing, a vicious cycle, and lingering and difficult to cure. Therefore, the present invention focuses on replenishing ancestral qi, soothing the lungs and relieving cough, moistening the lungs and resolving phlegm, while taking into account blood circulation and relieving wheezing, reducing the risk of acute exacerbation, improving exercise endurance, improving physical fitness and improving quality of life.

[0033] The second aspect of the present invention provides use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating early chronic obstructive pulmonary disease.

[0034] The third aspect of the present invention provides a medicine for treating early chronic obstructive pulmonary disease, comprising the above-mentioned Chinese medicine composition for treating early chronic obstructive pulmonary disease and pharmaceutically acceptable excipients.

[0035] The auxiliary materials include at least one or more of the following: disintegrants, emulsifiers, fillers, flavoring agents, wetting agents, excipients, adhesives, absorption promoters, colorants and solubilizers.

[0036] In some more preferred embodiments, the dosage form of the drug includes one or more of the following: granules, decoctions, pastes, pills, capsules, tablets, mixtures, suspensions, pastes, drops, powders or oral solutions.

[0037] The fourth aspect of the present invention provides a method for preparing the drug as a Chinese medicine decoction as follows:

[0038] Step 1, mix all the raw materials according to weight proportion, add purified water and soak;

[0039] Step 2: extract the raw material twice, filter and concentrate to obtain.

[0040] In some more preferred embodiments, in step 1, 6-7 times the amount of water is added to soak the API;

[0041] The extraction process in step 2 includes: collecting and filtering the medicinal solution after the first decoction for 2-4 hours, adding 5-6 times the amount of water of the total raw materials for the second decoction and decoct for 1-2 hours, collecting and filtering the medicinal solution, and combining the two extraction filtrates.

[0042] In some of the more preferred embodiments, the crude drug substance powder in the step 2 is extracted using a high-efficiency high-pressure continuous extraction technology, the mobile phase is pure water, and the extraction is performed twice continuously at 10-40°C with a high pressure difference of 0.1-35MPa and a time of 0.2-0.4 seconds, and the two extraction filtrates are combined.

[0043] In some of the more preferred embodiments, the extract in step 2 needs to be filtered twice, first with a 200-mesh fiber filter and then with a 500 nm ceramic membrane filter.

[0044] In the present invention, Radix Astragali and Radix Pseudostellariae are the main drugs, and Radix Astragali mainly has the effects of invigorating qi and raising yang, supporting ancestral qi, enhancing immunity and anti-inflammatory. Modern pharmacological studies have shown that the flavonoid compounds in Radix Astragali can significantly improve the body's immunity and regulate the activity of immune cells. Radix Pseudostellariae can invigorate qi and nourish yin, improve spleen and stomach function, and enhance the body's resistance to pathogens. The combination of the two can effectively enhance physical fitness, improve the patient's overall immune function, and enhance resistance to chronic lung inflammation through the comprehensive effects of invigorating qi and nourishing yin. The effect brought about by this synergistic effect is difficult to directly predict through a single ingredient.

[0045] Pinellia ternata, coltsfoot flower, perilla seed, and peucedanum chinense are the ministerial drugs. The combination of these four drugs together has the effects of drying dampness and strengthening the spleen, descending qi and resolving phlegm, and relieving cough and asthma. Modern pharmacological studies have confirmed that these drugs can effectively relieve excessive airway mucus secretion, thereby playing an expectorant role. They also have anti-inflammatory, antioxidant, antitussive, and antiasthmatic effects. In addition, as ministerial drugs, they also have the effect of enhancing the monarch drug. For example, perilla seed combined with astragalus can regulate the release of inflammatory factors through multiple components, multiple targets, and multiple pathways to achieve the effect of treating COPD. On the one hand, it cooperates with the monarch drug to enhance the function of the spleen and stomach in the middle jiao, and on the other hand, it strengthens the ability to relieve cough, resolve phlegm, and relieve asthma. This multi-target, multi-pathway mode of action makes its efficacy surpass the effect of a single component or conventional compatibility.

[0046] Angelica, Ophiopogon and Scutellaria are all adjuvants. Angelica contains organic acids, coumarins, phthalides and other ingredients, and has multiple biological activities such as anti-inflammatory, antioxidant, and anti-platelet aggregation. At the same time, it has the effect of moistening the intestines and laxatives, which can improve the dry stool that may be caused by other warm and dry drugs. Ophiopogon contains Ophiopogonin D, which has a wide range of pharmacological effects such as anti-inflammatory, anti-tumor, lipid-lowering, and gastrointestinal protection. It is a fine product for moisturizing and removing dryness, and can also alleviate the warm and dry nature of the monarch and ministerial drugs. Scutellaria has the effect of clearing heat and removing dampness. It contains compounds such as baicalin, baicalein, and flavonoids. It has a wide range of pharmacological effects such as regulating immunity, anti-tumor, antibacterial, antiviral, and antioxidant. It can reduce lung inflammation and further enhance the overall efficacy of the formula. The pharmacological action directions of Angelica, Ophiopogon and Scutellaria are different, covering multiple aspects such as nourishing blood and moistening the intestines, promoting fluid and moistening the lungs, clearing heat and removing dampness, etc., and cooperate with monarch and ministerial drugs, and have good clinical effects, and its effects are difficult to directly predict through conventional drug combinations.

[0047] The combination of Astragalus, Pseudostellaria, Pinellia, Coltsfoot Flos, Perilla Seed, Peucedanum, Angelica, Ophiopogon, and Scutellaria can replenish the vital energy, soothe the lungs and relieve cough, moisten the lungs and resolve phlegm, while also activating blood circulation and relieving asthma, strengthening the foundation, eliminating evil, and treating both the symptoms and the root cause, so that various symptoms can be relieved. The components synergize to enhance the effectiveness of the combination, so that the advantages of various drugs are fully exerted to improve the overall efficacy.

[0048] The present invention is further described in detail below in conjunction with specific embodiments:

[0049] Example 1

[0050] Preparation of decoction of the Chinese medicine composition of the present invention (I)

[0051] The following medicinal materials were weighed by weight: 15 parts of Astragalus, 15 parts of Pseudostellariae Radix, 10 parts of Pinellia, 10 parts of Coltsfoot Flos, 10 parts of Perilla Fructus, 10 parts of Angelica Sinensis, 10 parts of Peucedanum, 10 parts of Ophiopogon japonicus, and 10 parts of Scutellariae Baicalensis.

[0052] Weigh the medicinal materials, add 7 times the amount of water to soak, set the decoction temperature to 100℃, operate at micro-pressure, decoct for the first time, collect the medicinal liquid after 2 hours of decoction and extraction and filter, decoct for the second time, add 6 times the amount of water of the total raw materials to the filter residue, decoct and extract for 1 hour, collect the medicinal liquid and filter; combine the two filtrates and concentrate to obtain.

[0053] Example 2

[0054] Preparation of decoction of the Chinese medicine composition of the present invention (II)

[0055] The following medicinal materials were weighed by weight: 8 parts of Astragalus, 25 parts of Pseudostellariae Radix, 15 parts of Pinellia, 5 parts of Coltsfoot Flos, 10 parts of Perilla Fructus, 15 parts of Angelicae Sinensis, 20 parts of Peucedanum, 5 parts of Ophiopogon japonicus, and 10 parts of Scutellariae Baicalensis.

[0056] The preparation method is the same as Example 1.

[0057] Example 3

[0058] Preparation of decoction of the Chinese medicine composition of the present invention (III)

[0059] The following medicinal materials were weighed by weight: 10 parts of Astragalus, 20 parts of Pseudostellariae Radix, 15 parts of Pinellia, 10 parts of Coltsfoot Flos, 15 parts of Perilla Fructus, 15 parts of Angelica Sinensis, 10 parts of Peucedanum, 15 parts of Ophiopogon japonicus, and 15 parts of Scutellariae Baicalensis.

[0060] The preparation method is the same as Example 1.

[0061] Example 4

[0062] Preparation of decoction of the Chinese medicine composition of the present invention (IV)

[0063] The following medicinal materials were weighed by weight: 10 parts of Astragalus, 20 parts of Pseudostellariae Radix, 10 parts of Pinellia, 15 parts of Coltsfoot Flos, 12 parts of Perilla Fructus, 13 parts of Angelica Sinensis, 12 parts of Peucedanum, 15 parts of Ophiopogon japonicus, and 15 parts of Scutellariae Baicalensis.

[0064] The preparation method is the same as Example 1.

[0065] Example 5

[0066] Preparation of decoction of the Chinese medicine composition of the present invention (V)

[0067] The following medicinal materials were weighed by weight: 15 parts of Astragalus, 18 parts of Pseudostellariae Radix, 9 parts of Pinellia, 10 parts of Coltsfoot Flos, 12 parts of Perilla Fructus, 10 parts of Angelica Sinensis, 12 parts of Peucedanum, 10 parts of Ophiopogon japonicus, and 10 parts of Scutellariae Baicalensis.

[0068] The preparation method is the same as Example 1.

[0069] Example 6

[0070] Preparation of granules of the Chinese medicine composition of the present invention

[0071] The following medicinal materials were weighed by weight: 15 parts of Astragalus, 15 parts of Pseudostellariae Radix, 10 parts of Pinellia, 10 parts of Coltsfoot Flos, 10 parts of Perilla Fructus, 10 parts of Angelica Sinensis, 10 parts of Peucedanum, 10 parts of Ophiopogon japonicus, and 10 parts of Scutellariae Baicalensis.

[0072] Weigh the medicinal materials, add 7 times the amount of water, soak for 6 hours, set the decoction temperature to 100°C, decoct for the first time, collect the medicinal liquid after 2 hours of decoction and extraction, and filter it. For the second decoction, add 6 times the amount of water of the total raw material to the filter residue, decoct and extract for 1 hour, collect the medicinal liquid and filter it; combine the two filtrates and concentrate them, centrifuge and concentrate under reduced pressure to obtain a concentrated solution; spray dry the concentrated solution to obtain a dry powder, add an excipient such as maltodextrin or magnesium stearate and mix evenly to obtain the dry powder.

[0073] Example 7

[0074] Preparation of tablets of the Chinese medicine composition of the present invention

[0075] The following medicinal materials were weighed by weight: 15 parts of Astragalus, 15 parts of Pseudostellariae Radix, 10 parts of Pinellia, 10 parts of Coltsfoot Flos, 10 parts of Perilla Fructus, 10 parts of Angelica Sinensis, 10 parts of Peucedanum, 10 parts of Ophiopogon japonicus, and 10 parts of Scutellariae Baicalensis.

[0076] The medicinal materials were weighed, added with 7 times the amount of water, and soaked for 6 hours. The decoction temperature was set to 100°C. The first decoction was performed. After 2 hours of decoction and extraction, the medicinal liquid was collected and filtered. After the second decoction, 6 times the amount of water of the total raw material was added to the filter residue. After 1 hour of decoction and extraction, the medicinal liquid was collected and filtered. The two filtrates were combined and concentrated, and a concentrated solution was obtained by centrifugal filtration and reduced pressure concentration. The concentrated solution was spray-dried to obtain a dry powder. An excipient (maltodextrin or magnesium stearate) was added, mixed evenly, and pressed into tablets.

[0077] Example 8

[0078] Preparation of capsules of the Chinese medicine composition of the present invention

[0079] The following medicinal materials were weighed by weight: 15 parts of Astragalus, 15 parts of Pseudostellariae Radix, 10 parts of Pinellia, 10 parts of Coltsfoot Flos, 10 parts of Perilla Fructus, 10 parts of Angelica Sinensis, 10 parts of Peucedanum, 10 parts of Ophiopogon japonicus, and 10 parts of Scutellariae Baicalensis.

[0080] The medicinal materials are weighed, added with 7 times the amount of water, and soaked for 6 hours. The decoction temperature is set to 100°C. The first decoction is performed. After 2 hours of decoction and extraction, the medicinal liquid is collected and filtered. For the second decoction, 6 times the amount of water of the total raw material is added to the filter residue. After 1 hour of decoction and extraction, the medicinal liquid is collected and filtered; the two filtrates are combined and concentrated, and a concentrated solution is obtained by centrifugal filtration and reduced pressure concentration; the concentrated solution is spray-dried to obtain a dry powder; an excipient such as maltodextrin or magnesium stearate is added, mixed evenly, and filled into capsule particles.

[0081] Example 9

[0082] Preparation of pills of the Chinese medicine composition of the present invention

[0083] Referring to the weight proportions described in any one of Examples 1 to 4, each medicinal material is weighed and crushed, and the fine powder is passed through an 80-mesh sieve; an appropriate amount of honey is placed in an evaporating dish and heated. If there are impurities, they can be filtered out, and the heating is continued until the honey is refined, and the foam is skimmed off; the medicinal powder and the refined honey are mixed in a ratio of 1:1; the dough-like soft material is exposed to the air for a certain period of time; the soft material is rolled into round and smooth pellets, and wrapped with wax paper.

[0084] Example 10

[0085] Preparation of the Chinese medicine composition of the present invention

[0086] Referring to the weight ratio described in any one of Examples 1 to 4, weigh each medicinal material, mix it and crush it, add 10 times the amount of water, and boil it twice, each time for 1 hour; filter and combine the filtrate separately, concentrate it at 80 to 85° C. to a relative density of 1.20, add 3 times the amount of ethanol after natural cooling, stir evenly and let it stand; filter the supernatant, steam it until there is no alcohol taste and let it stand; then take the supernatant and concentrate it under reduced pressure, add an appropriate amount of pharmaceutical excipients, such as honey, white sugar, ethylparaben, benzopropionic acid, etc., to prepare a mixture.

[0087] Embodiment 11

[0088] Preparation of paste of Chinese medicine composition of the present invention

[0089] Referring to the weight proportions described in any one of Examples 1 to 4, weigh each medicinal material, mix it and crush it, add 10 times the amount of water, and boil it twice, each time for 1 hour; filter and combine the filtrate separately, concentrate it at 80-85°C to a relative density of 1.20, add 3 times the amount of ethanol after natural cooling, stir evenly and let it stand; filter the supernatant, steam it until there is no alcohol taste and let it stand; then take the supernatant and concentrate it under reduced pressure, obtain the extract and drip it on mulberry paper, and transfer it into a sterile bottle and seal it for storage if there is no water seepage.

[0090] Example 12

[0091] Preparation of powders of the Chinese medicine composition of the present invention

[0092] Referring to the weight proportions described in any one of Examples 1 to 4, each medicinal material was weighed, mixed, and then pulverized. The fine powder was passed through an 80-mesh sieve and wrapped with wax paper.

[0093] Clinical trial of the Chinese medicine composition of the present invention

[0094] 1 Materials and methods

[0095] 1.1 Research subjects and groups

[0096] A total of 53 patients with an average age of (68.92±7.95) years old who were treated in the Respiratory Department of Guangdong Provincial Hospital of Traditional Chinese Medicine from December 2021 to December 2023 and diagnosed with early COPD were randomly selected. The clinical symptoms and signs before and after taking the Chinese medicine composition were recorded in the form of outpatient clinics, electronic medical record system collection and telephone follow-up, and the efficacy of the treatment of early COPD was evaluated by comparing the improvement of clinical symptoms and signs.

[0097] 1.2 Diagnostic criteria

[0098] Western medicine diagnostic criteria: Referring to the "Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD2021 Edition)", ① Chronic respiratory symptoms (cough, sputum, dyspnea, etc.); ② Chronic obstructive pulmonary disease risk factors such as smoking and biofuel exposure; ③ FEV1 / FVC <70% after inhalation of bronchodilators, and the post-diastolic FEV1% ≥50% of the predicted value.

[0099] TCM diagnostic criteria: refer to the TCM Syndrome Diagnostic Criteria for Chronic Obstructive Pulmonary Disease (2011 Edition), ① Cough or wheezing, shortness of breath, aggravated by movement; ② Fatigue, weakness or spontaneous sweating, aggravated by movement; ③ Aversion to wind, easy to catch cold; ④ Poor appetite or less food; ⑤ Fullness of the stomach or abdomen or loose stools; ⑥ Pale or enlarged tongue or with teeth marks, thin white or greasy tongue coating, deep and thin pulse or weak pulse or deep and slow pulse. If any 3 of the above items are present, it can be identified as Qi deficiency syndrome or Qi deficiency as the main syndrome.

[0100] 1.3 Inclusion and Exclusion Criteria

[0101] Inclusion criteria:

[0102] (1) Aged between 40 and 85 years old, regardless of gender; strong compliance, able to cooperate with medication to complete the course of treatment; signed the informed consent form.

[0103] (2) COPD that meets the Western medical diagnosis of GOLD1-2, with the TCM syndrome type being Qi deficiency or with Qi deficiency as the predominant symptom.

[0104] Exclusion criteria:

[0105] (1) Patients with bronchial asthma, bronchiectasis, obstructive sleep apnea syndrome, lung malignancy or active pulmonary tuberculosis;

[0106] (2) COPD patients who have experienced acute exacerbation in the past four weeks;

[0107] (3) A history of allergic or hypersensitivity reaction to any component of the study drug, or a disease that the researcher believes should be prohibited from using the study drug;

[0108] (4) TCM syndrome differentiation takes yin deficiency as the main symptom;

[0109] (5) Patients who have been taking Chinese herbal medicines (such as astragalus, ginseng, codonopsis, etc.) for a long time;

[0110] (6) Patients with severe cardiovascular, cerebrovascular, liver and kidney diseases or mental illness;

[0111] (7) Those whose blood alanine aminotransferase (ALT), aspartate aminotransferase (AST) or blood creatinine (Scr) exceeds 1.5 times the upper limit of normal value;

[0112] (8) Those who have received other investigational drugs within 1 month before the screening visit;

[0113] (9) Those who are unable to cooperate in completing lung function tests;

[0114] (10) Those who have participated or plan to participate in other clinical trials during the screening period.

[0115] 1.4 Treatment options

[0116] Specific plan:

[0117] The treatment group was treated with the granules of the Chinese medicine composition in Example 6 of the present invention, comprising 15 parts of Astragalus, 15 parts of Radix Pseudostellariae, 10 parts of Rhizoma Pinelliae, 10 parts of Flos Coltsfoot, 10 parts of Fructus Perillae, 10 parts of Radix Angelicae Sinensis, 10 parts of Peucedanum, 10 parts of Radix Ophiopogonis, and 10 parts of Radix Scutellariae to prepare granules.

[0118] The control group is treated with placebo granules of the Chinese medicine composition of the present invention. The preparation method of the placebo granules comprises the following steps:

[0119] (1) Add a certain amount of purified water to a batching tank and heat it to 50-65° C., then add caramel pigment, sucrose octaacetate, tartrazine, steviol glycoside, corn starch, maltodextrin, dextrin, and Chinese medicine composition preparation granules in sequence, stir evenly, and then spray dry to obtain a placebo granule spray-dried powder; pass through an 80-mesh sieve to obtain a placebo granule extract;

[0120] (2) Take lemon yellow, add corn starch, caramel pigment, and compound stabilizer No. 1 (composed of hydroxypropyl methylcellulose, sodium carboxymethylcellulose, and xanthan gum), mix, add placebo granule extract, mix evenly, and obtain a placebo granule mixture;

[0121] (3) using a dry granulator to granulate, and using 14 and 30 mesh sieves to screen the granules, and controlling the particle size to be in the range of 14-30 mesh, thereby obtaining the placebo granules of the traditional Chinese medicine composition.

[0122] Dosage: 1 dose per day (1 dose is 100g), divided into two doses.

[0123] Treatment course: 1 week of introduction, 12 weeks of treatment, and 12 weeks of follow-up.

[0124] Regulations on combined medication: In accordance with the "Guidelines for the Diagnosis and Treatment of COPD (2021 Revised Edition)" and GOLD2021, in principle, other Chinese medicines, Chinese patent medicines or Western medicines other than study drugs, LAMA and ICS / LABA shall not be used. If the patient experiences shortness of breath during treatment, ventolin can be used temporarily; if an acute attack of COPD occurs, treatment should be carried out according to the guidelines, and changes in the condition should be recorded in detail.

[0125] 1.5 Observation indicators

[0126] (1) CAT score: reflects the impact of COPD on quality of life. It includes 8 items with a total score ranging from 0 to 40 points. The higher the total score, the worse the quality of life.

[0127] (2) Cough and Sputum Assessment Questionnaire (CASA-Q): This questionnaire assesses the patient's cough and sputum symptoms and the impact of the symptoms on their quality of life. It consists of 20 items, each with a score of 0-4. The regional score is (the total score of all questions in each region / the maximum score of each region) multiplied by 100. The higher the score, the better the patient's health status.

[0128] (3) Annual average number of acute exacerbations: closely related to quality of life, hospitalization rate and disease progression.

[0129] (4) 6-minute walk distance (6MWT): The exercise endurance of the patient is assessed by measuring the distance the patient can walk briskly on a flat, hard surface within 6 minutes.

[0130] The above indicators were evaluated in the lead-in period (V1), before treatment (V2), the 6th week of treatment (V3), the 12th week of treatment (V4), the 6th week of follow-up (V5), and the 12th week of follow-up (V6), and recorded in the clinical case observation form.

[0131] 1.6 Statistical methods

[0132] Epidata 3.1 was used for data management. SPSS 17.0 was used for statistical analysis. All measurement data were described by (x±s), and count data were described by rate or percentage. Normally distributed measurement data were compared between groups using independent sample t test, and data that did not conform to normal distribution were compared with rank sum test; count data were compared between treatment groups using chi-square test or Fisher's exact probability method. p<0.05 was considered statistically significant.

[0133] 1.7 Statistical Results

[0134] 1.7.1 CASA-Q cough symptom score

[0135] At the 6th and 12th weeks of treatment, the CASA-Q cough symptom score of the treatment group was significantly better than that of the control group (15.07 vs 5.25, p = 0.043; 13.78 vs 0.91, p = 0.011). See Table 1 Comparison of the improvement of cough symptom scores at each visit point in the treatment group and the control group compared with before treatment. Figure 1 Comparison of the improvement degree of cough symptom scores at each visit point between the treatment group and the control group compared with before treatment.

[0136] Table 1 Comparison of the improvement of cough symptom scores at each visit point between the treatment group and the control group compared with before treatment

[0137]

[0138]

[0139] As shown in Table 1 and Figure 1 As shown, the CASA-Q scale further focuses on evaluating the improvement of the granules prepared in Example 6 on the cough and sputum symptoms of early COPD. The results show that after 12 weeks of treatment with the granules prepared in Example 6, the patient's cough symptoms improved, and the clinical effect was significant.

[0140] 1.7.2 CASA-Q sputum symptom score

[0141] At the 12th week of treatment, the CASA-Q expectoration symptom score of the treatment group was better than that of the control group, and the difference was statistically significant (77.24 vs 66.35, p = 0.036). See Table 2 Comparison of expectoration symptom scores at each visit point between the treatment group and the control group and Figure 2 Comparison of expectoration symptom scores at each visit point between the treatment group and the control group.

[0142] Table 2 Comparison of cough symptom scores at each visit point between the treatment group and the control group

[0143]

[0144] As shown in Table 2 and Figure 2 As shown, the CASA-Q scale further focuses on evaluating the improvement of cough and sputum symptoms of early COPD by Jianpi Shufei granules. The results show that after 12 weeks of treatment with the granules prepared in Example 6, the sputum symptoms of early COPD patients were improved, and the clinical effect was significant.

[0145] 1.7.3 CAT Scoring

[0146] After 12 weeks of treatment, at the 6th and 12th weeks of follow-up, the CAT score of the treatment group was better than that of the control group, and the difference was statistically significant (-4.12 vs -0.96, p = 0.035; -4.19 vs -0.74, p = 0.015). See Table 3 Comparison of the improvement of CAT scores at each visit point in the treatment group and the control group compared with before treatment. Figure 3 Comparison of the improvement of CAT scores at each visit point between the treatment group and the control group compared with before treatment.

[0147] Table 3 Comparison of the improvement of CAT scores at each visit point between the treatment group and the control group compared with before treatment

[0148]

[0149] As shown in Table 3 and Figure 3As shown, the CAT score is a scale that can comprehensively reflect the impact of COPD on the quality of life of patients, including comprehensive assessments of cough, sputum, chest tightness, shortness of breath, sleep impact, daily activity impact, mental state impact, etc. The higher the total score, the more severe the condition and the worse the quality of life. After 12 weeks of treatment with the particles prepared in Example 6, the CAT score of patients with early COPD decreased significantly (an average decrease of 4.12 and 4.19 points), indicating that the Chinese medicine composition prepared by the present invention has a multi-faceted improvement effect on the symptoms of cough, sputum, chest tightness, shortness of breath, etc. in patients with early COPD, with outstanding efficacy, and can improve the comprehensive quality of life of patients.

[0150] 1.7.4 Annual average number of acute exacerbations per capita

[0151] There was no statistically significant difference in the average annual number of acute exacerbations between the two groups, but the number of acute exacerbations in the treatment group was less than that in the control group. See Table 4 for a comparison of the average annual number of acute exacerbations in the treatment group and the control group.

[0152] Table 4 Comparison of the number of acute exacerbations per capita per year between the treatment group and the control group

[0153]

[0154]

[0155] As shown in Table 4, although there is no statistical difference between the two groups of results in terms of the indicator of the number of acute exacerbations per capita per year, it can be seen from the data that after 12 weeks of treatment with the particles prepared in Example 6, the number of acute exacerbations per capita per year in patients with early COPD was reduced by an average of 0.24 times compared with those who did not take the drug. For patients with COPD, each acute exacerbation will further deteriorate lung function, and further increase the risk of acute exacerbations in the future, and increase the risk of future hospitalization and mortality. Therefore, the trend of the particles prepared in Example 6 to reduce the number of acute exacerbations per year in patients with early COPD suggests that it has potential clinical value in reducing further deterioration of lung function and reducing the risk of future hospitalization and mortality.

[0156] 1.7.5 6MWT

[0157] At the 6th week of follow-up, the difference in the increase of 6MWT distance between the two groups was statistically significant (19.27 vs -10.19, p = 0.035), see Table 5 Comparison of the improvement of 6MWT distance at each visit point in the treatment group and the control group compared with before treatment. Figure 4 Comparison of the improvement of 6MWT distance at each visit point between the treatment group and the control group compared with before treatment.

[0158] Table 5 Comparison of the improvement of 6MWT distance at each visit point between the treatment group and the control group compared with before treatment

[0159]

[0160] As shown in Table 5 and Figure 4 As shown, the 6MWT index is specifically used to evaluate the patient's exercise tolerance and is closely related to the long-term prognosis. The research results indicate that after the early COPD patients received 12 weeks of treatment with the particles prepared in Example 6, the 6MWT distance increased by an average of 19.27 meters during the follow-up period, indicating that the particles prepared in Example 6 have an improving effect on the overall health status of early COPD patients, can improve exercise tolerance, and improve prognosis.

[0161] 1.7.5 Security

[0162] There were 6 adverse events in the treatment group, including 5 cases of acute upper respiratory tract infection and 1 case of acute gastroenteritis. There were 12 adverse events in the control group, including 4 cases of acute upper respiratory tract infection, 4 cases of osteoarthritis, 1 case of stomachache, 1 case of chest tightness and shortness of breath after quarreling with others, and 1 case of hematuria. There was no statistically significant difference in the incidence of adverse events between the two groups. The severity of adverse events was judged to be mild, with no causal relationship with the trial drugs, and the safety was good.

[0163] In summary, the Chinese medicine composition for treating early COPD provided by the present invention has the effects of replenishing zongqi, soothing the lungs and relieving cough, moistening the lungs and resolving phlegm, while taking into account the effects of promoting blood circulation and relieving asthma, treating both the symptoms and the root causes, thereby improving the patient's cough and sputum symptoms and reducing the risk of acute exacerbation. Clinical trial results show that the Chinese medicine composition can effectively improve clinical symptoms such as cough, sputum, shortness of breath, etc., reduce the risk of acute exacerbation, improve exercise endurance, improve physical fitness and improve quality of life, and has good safety, providing a new selection basis for the treatment of early clinical COPD.

[0164] 1.8 Specific clinical examples

[0165] Clinical Case 1:

[0166] District XX, male, 71 years old, born in 1950, lives in Huangpu District, Guangzhou. History of COPD (GOLD level 2), usually regularly inhaled umeclidinium bromide and vilanterol, visited the doctor on December 8, 2021, with symptoms of cough, obvious at night, aggravated by lying flat, coughing up white foamy sputum, a little shortness of breath after activity, occasional throat itching, easy to catch a cold, cold hands and feet, afraid of heat, easy to sweat, easy to get angry, unformed stool, red tongue with light white greasy coating, and slippery pulse. After taking the granules prepared in Example 6 for 14 days, the night cough improved significantly, the amount of sputum decreased, and he could go to the fields to do farm work, and the stool was adjusted. The granules prepared in Example 6 were taken for conditioning for 2 months. The lung ventilation was checked in June 2022 for mild obstruction, diastolic negative, and FEV1%pre=75.56% (GOLD level 2), indicating that the COPD condition was under stable control.

[0167] Clinical Case 2:

[0168] He Moumou, male, 63 years old, born in 1959, lives in Baiyun District, Guangzhou. History of chronic obstructive pulmonary disease (GOLD level 2), visited the doctor in January 2022, complained of an acute exacerbation 2 weeks ago, and the current symptoms showed worsening of asthma, obvious after activity, cough and sputum, yellow and white sputum in the morning, a little itchy throat, sore throat, occasional dry mouth and bitter mouth, dry stool, poor sleep, red tongue, thick and greasy yellow fur, and a stringy and slippery pulse. After taking the granules prepared in Example 6 for 7 days, the symptoms of cough, sputum, shortness of breath, etc. were significantly relieved, a little itchy throat, no sore throat, a little dry mouth, smooth bowel movements, and improved sleep.

[0169] Clinical Case 3:

[0170] He Moumou, male, 77 years old, born in 1945, lives in Liwan District, Guangzhou. History of chronic obstructive pulmonary disease, usually inhaled Xinbicol 320 / 9ug 1 inhalation bid regularly. When he was diagnosed, he complained that his asthma had slightly worsened recently, his cough had increased, there was not much sputum, itchy throat, no fever, chills and other discomforts, a little bitter mouth, poor sleep, good appetite, and normal bowel movements. The tongue was pale and dark, the fur was thin and white, and the pulse was stringy. Physical examination: the breath sounds of both lungs were slightly weak, and no obvious dry or wet rales were heard. After taking the granules prepared in Example 6 for 1 month, the telephone follow-up reported that the condition was stable recently, there was no obvious shortness of breath, occasional cough, not much sputum, and good appetite and sleep.

[0171] Clinical Case 4:

[0172] Xie, male, 69 years old, born in 1953, lives in Liwan District, Guangzhou. History of chronic obstructive pulmonary disease, visited the doctor on February 18, 2022, complained of repeated coughs in recent days, a lot of sputum, white and can be coughed up, a little shortness of breath after activity, no throat itching and soreness, no fever and chills, no nasal congestion and runny nose, poor sleep, regular urination, constipation during defecation. The tongue is light red, the tongue coating is yellow and greasy, and the pulse is stringy. After taking the granules prepared in Example 6 for 2 weeks, the follow-up report complained of significantly reduced cough, less white sputum, shortness of breath after activity, poor sleep, and 1-2 stools / day, formed. I continued to take the prescription for 1 month, and followed up and complained of less cough and sputum, no obvious shortness of breath, and stable condition control.

[0173] Clinical Case 5:

[0174] Luo Moumou, female, 75 years old, born in 1947, lives in Yuexiu District, Guangzhou. She has a history of chronic obstructive pulmonary disease for more than 20 years. She has been treated with long-term inhalation of Symbicort, but still has cough, sputum, and a little shortness of breath. After taking the granules prepared in Example 6 for 3 months, the symptoms of cough, sputum, shortness of breath, etc. were significantly improved compared with before, and the granules prepared in Example 6 were continued in the follow-up outpatient clinic.

[0175] Clinical Case 6:

[0176] Huang, male, 66 years old, born in 1956. History of COPD, standardized inhalation of budegfo inhalation aerosol treatment, in June 2022, he was diagnosed with obvious shortness of breath, not much cough and sputum, and occasionally coughed up white sticky sputum, and the mMRC was evaluated as 2 points (walking on flat ground is slower than that of peers, and he needs to stop and rest when walking). After taking the granules prepared in Example 6 for 1 month, the shortness of breath was improved compared with before, and the mMRC was evaluated again as 1 point. He was short of breath only when walking fast or climbing, and could go up to the 4th floor on the stairs without obvious coughing and sputum. After that, the granules prepared in Example 6 were given for long-term conditioning, and the COPD condition was controlled and stabilized.

Claims

1. A Chinese medicine composition for treating early chronic obstructive pulmonary disease, characterized in that: The raw materials are included by weight: 8-25 parts of astragalus, 8-25 parts of pseudoginseng, 5-20 parts of pinellia, 5-20 parts of coltsfoot, 5-20 parts of perilla, 5-20 parts of angelica, 5-20 parts of peucedanum, 5-20 parts of ophiopogon, and 5-20 parts of scutellaria.

2. The Chinese medicine composition for treating early chronic obstructive pulmonary disease according to claim 1, characterized in that: The raw materials are included by weight: 10-20 parts of astragalus, 10-20 parts of pseudoginseng, 8-15 parts of pinellia, 8-15 parts of coltsfoot, 8-15 parts of perilla, 8-15 parts of angelica, 8-15 parts of peucedanum, 8-15 parts of ophiopogon, and 8-15 parts of scutellaria.

3. The Chinese medicine composition for treating early chronic obstructive pulmonary disease according to claim 1, characterized in that: The raw materials are included by weight: 15 parts of astragalus, 15 parts of pseudoginseng, 10 parts of pinellia, 10 parts of coltsfoot lily, 10 parts of perilla seed, 10 parts of angelica, 10 parts of peucedanum, 10 parts of ophiopogon, 10 parts of radix scutellariae, and 10 parts of scutellariae.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating early chronic obstructive pulmonary disease.

5. A drug for treating early chronic obstructive pulmonary disease, characterized in that: The invention comprises the Chinese medicine composition for treating early chronic obstructive pulmonary disease according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

6. The drug for treating early chronic obstructive pulmonary disease according to claim 5, characterized in that: The dosage form of the drug includes one or more of the following: granules, decoctions, pastes, pills, capsules, tablets, mixtures, suspensions, pastes, drops, powders or oral solutions.

7. The method for preparing the drug for treating early chronic obstructive pulmonary disease according to claim 5 or 6, characterized in that: The medicine is a Chinese medicine decoction, and its preparation method is as follows: Step 1, mix all the raw materials according to weight proportion, add purified water and soak; Step 2: extract the raw material twice, filter and concentrate to obtain.

8. The preparation method according to claim 7, characterized in that: In the step 1, add 6-7 times the amount of water as the raw material to soak; The extraction process in step 2 includes: collecting and filtering the medicinal solution after the first decoction for 2-4 hours, adding 5-6 times the amount of water of the total raw materials for the second decoction and decoct for 1-2 hours, collecting and filtering the medicinal solution, and combining the two extraction filtrates.

9. The preparation method according to claim 7, characterized in that: In the step 2, the crude drug substance powder is extracted by high-efficiency high-pressure continuous extraction technology, the mobile phase is pure water, at 10-40°C, a high pressure difference of 0.1-35MPa, a time of 0.2-0.4 seconds, two consecutive extractions are performed, and the two extraction filtrates are combined.

10. The preparation method according to claim 7, characterized in that: The extract in step 2 needs to be filtered twice, first with a 200-mesh fiber filter and then with a 500nm ceramic membrane filter.

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