Traditional Chinese medicine composition for improving stable-phase symptoms of chronic obstructive pulmonary disease

Abstract

The invention relates to a traditional Chinese medicine composition for improving symptoms of chronic obstructive pulmonary disease in a stable phase. The traditional Chinese medicine composition is prepared from the following medicinal materials in parts by weight: 13 to 17 parts of radix astragali preparata, 13.5 to 16.5 parts of radix codonopsis, 9 to 11 parts of radix rehmanniae preparata, 13.5 to 16.5 parts of fructus corni, 9 to 11 parts of cortex mori radicis, 9 to 11 parts of radix platycodonis, 5 to 7 parts of radix glycyrrhizae preparata, 5 to 7 parts of lumbricus, 27 to 33 parts of rhizoma dioscoreae nipponicae, 16 to 18 parts of thorny elaeagnus root, 7 to 9 parts of calcined fluorite and 13.5 to 16.5 parts of radix ophiopogonis. Clinical test research shows that the traditional Chinese medicine composition disclosed by the invention can obviously improve the stable-phase symptoms of the chronic obstructive pulmonary disease, and has obvious curative effects in the aspects of improving the symptoms such as cough, expectoration and chest distress, shortening the cough relieving time and curing time of a patient, improving the life quality and lung function indexes of the patient and the like; the result that the medicine is normal before treatment and abnormal after treatment is not found, and the medicine safety is good.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for improving the symptoms of chronic obstructive pulmonary disease in the stable phase. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease characterized by airway inflammation, which is mainly caused by smoking, air pollution, genetics and other factors. Western medicine mainly treats COPD by relieving symptoms such as anti-inflammatory and bronchial dilation, but its potential risks are that the bacterial resistance rate increases year by year, there are many adverse reactions, poor patient compliance, some patients cannot tolerate mechanical ventilation treatment, lung function shows a progressive decline, and the long-term prognosis is poor.

[0003] According to the current international and domestic authoritative diagnosis and treatment standards, COPD is divided into a stable period and an acute exacerbation period based on the stability and severity of the disease. In clinical practice, the "stable period" is a key stage of the disease, showing relatively stable clinical characteristics, which plays a vital role in the long-term management of the disease. This stage is also regarded as the core part of the disease process. In the clinical practice of traditional Chinese medicine, the stable period of COPD is mostly dominated by a state of relative balance between deficiency and excess, and subtle differences between deficiency and excess and their interrelationships need to be carefully distinguished during syndrome differentiation, while focusing on the accurate identification of single syndromes and complex syndromes. Since the syndrome differentiation and treatment and prescription compatibility in the stable period are both faced with challenges, more precise guidance and scientific verification are needed to ensure the effectiveness and safety of treatment.

[0004] The stable phase of COPD includes two main types: lung and kidney deficiency and phlegm and blood stasis blocking the lung. At present, Chinese patent CN119345319A discloses a Chinese medicine compound for treating the stable phase of chronic obstructive pulmonary disease and its application, wherein the Chinese medicine composition contains epimedium, curculigo, astragalus, salvia miltiorrhiza, earthworm, dactylum, ophiopogon japonicus, scutellaria baicalensis, adenophora australis, dried ginger, white mulberry bark, pinellia ternata, coptis chinensis and ginkgo. The prescription is mainly based on warming yang and replenishing qi (epimedium, curculigo, astragalus), and also clears heat and resolves phlegm (scutellaria baicalensis, white mulberry bark) and activates blood circulation and dredges (salvia miltiorrhiza, earthworm, dactylum australis). It has the risk of warming and drying to damage yin: the proportion of warming yang drugs such as epimedium, curculigo, and dried ginger is large, and long-term use may damage lung yin, especially for patients with yin deficiency type COPD (such as those with red tongue and less coating, dry cough and no phlegm), which may aggravate the symptoms; although ophiopogon japonicus and adenophora australis can nourish yin, their dosage is relatively weak compared with warming yang drugs, and it is difficult to completely balance them. In addition, pinellia tuber, dried ginger, coptis root, etc. may irritate the gastrointestinal tract and easily cause abdominal distension in people with weak spleen and stomach. The dosage of each herbal medicine in this prescription spans a wide range, and the rigor of the compatibility is questionable.

[0005] Chinese patent CN119139398A discloses a Chinese medicine compound for treating chronic obstructive pulmonary disease in the stable stage of lung and kidney deficiency syndrome, and its preparation method and application. The raw materials of the Chinese medicine compound include: 18-22g of Codonopsis pilosula, 9-12g of Morinda officinalis, 12-16g of roasted Astragalus membranaceus, 7-11g of Atractylodes macrocephala, 9-11g of Rehmannia glutinosa, 9-12g of Cuscuta chinensis, 3-8g of Cinnamon twig, 10-15g of Salvia miltiorrhiza and 2-6g of roasted Ephedra sinica. The prescription focuses on tonifying the lung and kidney (Codonopsis pilosula, Morinda officinalis, Rehmannia glutinosa), invigorating qi and activating blood circulation (roasted Astragalus membranaceus, Salvia miltiorrhiza), and assisting with pungent and warm lung-clearing (roasted Ephedra sinica, Cinnamon twig). Among them, the side effects of pungent and warm drugs are prominent. Roasted Ephedra sinica contains ephedrine, which may induce palpitations and increase blood pressure, and has a higher risk for COPD patients with cardiovascular diseases; Cinnamon twig is pungent and warm, which may aggravate hot flashes and night sweats in patients with yin deficiency and internal heat. The prescription contains only one herb, Rehmannia glutinosa, for nourishing yin and moistening the lungs, and the dosage is relatively low. It has limited efficacy for COPD of lung and kidney yin deficiency type (such as wheezing with dry throat, and little sticky sputum).

[0006] Chinese patent CN118217352A discloses a Chinese medicine composition for treating stable chronic obstructive pulmonary disease, which contains 15-45 parts of astragalus, 2-18 parts of white atractylodes, 2-18 parts of siler, 5-25 parts of prepared rehmannia, 10-30 parts of yam, 5-25 parts of cornus, 2-18 parts of salt alisma, 2-18 parts of peony bark, 5-25 parts of tuckahoe, 5-25 parts of ginseng, 10-30 parts of roasted epimedium, 2-18 parts of schisandra, 1-10 parts of gecko, 15-45 parts of walnut kernel, 2-18 parts of bitter almond, 2-18 parts of platycodon, 5-25 parts of thunbergii, and 100-150 parts of honey. The prescription comprehensively replenishes qi (astragalus, ginseng), nourishes yin (prepared rehmannia, cornus), promotes qi and relieves asthma (gecko, walnut kernel), and takes into account the phlegm and cough (platycodon, thunbergii). However, the medicinal taste is complex, the main ingredients are unclear, and the treatment direction is unclear, which may reduce the targeting of the main symptoms. Gecko is an endangered species and is very rare and difficult to obtain. Honey is not suitable for diabetic COPD patients. Similarly, the dosage of each medicinal material in this prescription spans a large range, and the rigor of the compatibility is still questionable.

[0007] In view of the shortcomings of the prior art, the present invention is based on the holistic treatment concept of harmony, balance and coordination, and proposes a Chinese medicine composition for improving the symptoms of stable chronic obstructive pulmonary disease, which can attack and supplement at the same time, harmonize qi and blood, reconcile yin and yang, coordinate the five flavors, and treat internal organs at the same time. Summary of the invention

[0008] 1. Technical issues to be resolved In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for improving the symptoms of stable chronic obstructive pulmonary disease, which solves the technical problems of the traditional Chinese medicine composition in the prior art, such as warm and dryness damaging yin, the use of a large number of pungent and warm medicinal materials in the formula, complex medicinal flavors, and insufficient targeting of the main symptoms.

[0009] (II) Technical solution In a first aspect, the present invention provides a traditional Chinese medicine composition for improving the symptoms of stable chronic obstructive pulmonary disease, which is made of a medicinal material composition comprising the following components, in parts by mass: 13-17 parts of roasted astragalus, 13.5-16.5 parts of codonopsis pilosula, 9-11 parts of cooked rehmannia, 13.5-16.5 parts of cornus officinalis, 9-11 parts of mulberry bark, 9-11 parts of platycodon, 5-7 parts of roasted liquorice, 5-7 parts of earthworm, 27-33 parts of rhizoma dioscoreae, 16-18 parts of elaeagnus root, 7-9 parts of calcined purple quartz and 13.5-16.5 parts of ophiopogon japonicus.

[0010] According to a preferred embodiment of the present invention, the medicinal material composition comprises: 15 parts of roasted Astragalus, 15 parts of Codonopsis, 10 parts of Rehmannia, 15 parts of Cornus, 10 parts of Morus alba, 10 parts of Platycodon, 6 parts of roasted Licorice, 6 parts of Pheretima, 30 parts of Rhizoma Dioscoreae, 17 parts of Elaeagnus Root, 8 parts of Amethyst and 15 parts of Radix Ophiopogonis; or, The medicinal material composition comprises: 15 parts of roasted Astragalus, 16 parts of Codonopsis, 9 parts of Rehmannia, 14 parts of Cornus, 10 parts of Morus alba, 10 parts of Platycodon, 7 parts of roasted Licorice, 5 parts of Pheretima, 32 parts of Rhizoma Dioscoreae, 18 parts of Elaeagnus Root, 9 parts of Amethyst and 16.5 parts of Radix Ophiopogonis; or, The medicinal material composition comprises: 17 parts of roasted Astragalus, 16.5 parts of Codonopsis, 11 parts of Rehmannia, 16.5 parts of Cornus, 9 parts of Morus alba, 9 parts of Platycodon, 5 parts of roasted Licorice, 7 parts of Pheretima, 33 parts of Rhizoma Dioscoreae, 16 parts of Elaeagnus Root, 8 parts of Amethyst and 14 parts of Radix Ophiopogonis; or, The medicinal material composition comprises: 13 parts of roasted astragalus, 13.5 parts of codonopsis pilosula, 11 parts of cooked rehmannia, 13.5 parts of cornus officinalis, 11 parts of mulberry bark, 11 parts of platycodon, 7 parts of roasted liquorice, 5 parts of earthworm, 27 parts of rhizoma dioscoreae, 16 parts of elaeagnus root, 7 parts of calcined purple quartz and 13.5 parts of ophiopogon.

[0011] According to a preferred embodiment of the present invention, the medicinal material composition further comprises 12-15 portions of houttuynia cordata. When heat syndrome is obvious, 12-15 portions of houttuynia cordata are added to strengthen the heat-clearing effect of the Chinese medicinal material composition.

[0012] According to a preferred embodiment of the present invention, the Chinese medicine composition is a decoction, capsule, tablet, pill, oral liquid, paste or powder.

[0013] According to a preferred embodiment of the present invention, the Chinese medicine composition is a decoction, and its preparation method is as follows: weigh the medicinal materials according to the components of the medicinal material composition, rinse the floating soil with clean water, dry and sterilize with microwaves; soak the Rhizoma Dioscoreae in 40-50°C warm water for 10-15min to soften the fibers, and then cut the roasted Astragalus, Codonopsis and Rhizoma Dioscoreae into 3-5mm thick slices; bake the earthworm to a moisture content of ≤8%, and then soak it in 70-75% ethanol for 20-30min after crushing, and filter out the ethanol; first put the calcined purple quartz into water and boil it for 30-50min, then put all the remaining medicinal materials into water and soak it for 30-40min, add water to exceed the surface of the medicine by 2-3cm, boil it for the first time for 15-20min, pour out 1 / 2 of the medicinal liquid, then add warm water for a second boiling for 25-35min, pour out all the medicinal liquid, combine the two medicinal liquids and mix them evenly to obtain the decoction.

[0014] According to a preferred embodiment of the present invention, the preparation method of the Chinese medicine composition comprises the following steps: Step 1: weigh the medicinal materials according to the components of the medicinal material composition, wash the floating soil with water, dry it, and then sterilize it with microwave; Step 2: Soak the Rhizoma Dioscoreae in 40-50℃ warm water for 10-15min to soften the fibers, then cut the roasted Astragalus, Codonopsis and Rhizoma Dioscoreae into 3-5mm thick slices; crush the calcined purple quartz into 80 mesh fine powder; dry the earthworm until the moisture content is ≤8%, and soak it in 70-75% ethanol for 20-30min to inactivate enzymes and reduce the fishy smell, and then filter to remove the ethanol; Step 3: Mix all the medicinal materials with 8 times the weight of water, and add 5wt% rice vinegar or citric acid to the water (to increase the Ca content in calcined purple quartz). 2+ Dissolution rate), pre-soak for 0.5-1h, heat to 90-95℃ and keep warm for 30-40min, stir synchronously, cool to 60-70℃, add 0.1% cellulase (w / w), enzymolysis for 40-70min, during the extraction process, connect a condensation reflux device to the top of the extraction tank to collect the volatile components of Morus alba and Platycodon grandiflorus (such as mulberry ketone A and platycodon saponin D), and finally add the collected condensate back to the liquid medicine; Step 4: Concentrate the extract under the conditions of vacuum degree -0.08MPa and temperature of 55-65°C to obtain a concentrated paste with a relative density of 1.25-1.30 at 70°C; Step 5: Add auxiliary materials to the concentrated paste and process it according to the preparation process of capsules, tablets, pills, pastes or powders. The finished product is sterilized by γ-ray irradiation at a dose of 8-10 kGy and packaged.

[0015] According to a preferred embodiment of the present invention, if the Chinese medicine composition is a powder, the method of step 5 is: the concentrated paste is mixed with dextrin and microcrystalline cellulose in a mass ratio of 1:0.9:0.3, and directly made into 80-100 mesh particles with a moisture content of ≤5% by a centrifugal spray drying tower (inlet air temperature 160°C, outlet air temperature 85°C).

[0016] Preferably, if the Chinese medicine composition is a capsule, the method of step 5 is: mixing the concentrated paste with dextrin and microcrystalline cellulose in a mass ratio of 1:0.9:0.3, directly preparing 80-100 mesh granules through a centrifugal spray drying tower, and then filling the capsules.

[0017] Preferably, if the traditional Chinese medicine composition is a tablet, the method of step 5 is: the concentrated paste is evenly spread on a stainless steel tray, placed in a vacuum drying oven and dried to a moisture content of ≤5% to obtain a dry paste, the dry paste is processed by a jet mill to a particle size of 80-100 mesh, sieved and mixed evenly with the auxiliary materials, sprayed with a wetting agent (such as a 5% HPMC solution) for granulation, the moisture content of the wet granules is controlled to be 8-12%, the wet granules are dried in a fluidized bed dryer to a moisture content of ≤3% to obtain dry granules, the dry granules are sieved through an oscillating sieve, magnesium stearate is added for secondary mixing, and the tablets are compressed on a machine, and the compressed tablets that pass the inspection are coated with an HPMC-based coating liquid to obtain tablets.

[0018] According to a preferred embodiment of the present invention, the preparation method of the calcined purple quartz is: smash the raw ore into small pieces, calcine the purple quartz in a vacuum furnace (pressure ≤ 0.01MPa), the calcination temperature is 750-800°C, and the calcination time is 2-3h to reduce fluoride volatilization pollution.

[0019] The preparation methods of roasted Astragalus, Rehmannia glutinosa, and roasted Licorice can be found in the "Pharmacopoeia of the People's Republic of China 2020 Edition". The medicinal materials that have undergone standardized processing can be used as raw materials for the Chinese medicine composition in this case, and can also be prepared according to the following steps.

[0020] The preparation method of roasted Astragalus: take Astragalus slices, put 25% by weight of honey in a pot, heat on low heat and stir constantly, and when the honey is light yellow, slightly sticky and has no obvious bubbles, pour in the Astragalus slices, mix well, and make the honey evenly adhere; then heat and stir-fry over low heat, and continue to stir-fry until the surface of the Astragalus slices is dark yellow and not sticky, then remove from the pot; place the fried Astragalus in a ventilated and dry place to dry, or dry it at 40-60℃, and after drying, use a sieve to remove debris and impurities to obtain roasted Astragalus.

[0021] Processing method of cooked rehmannia: take raw rehmannia, put it in 30-60% by weight of yellow wine and mix well, so that the yellow wine can fully soak the raw rehmannia; then put the soaked raw rehmannia and yellow wine into a suitable container, seal it, heat it in water and stew it until the wine is absorbed. The stewing time is relatively long, about 36-48 hours. Take out the raw Rehmannia root when it is black inside and out, soft in texture and sweet in taste; place it in a ventilated place to dry until there is no obvious moisture on the surface, then cut it into thick slices or blocks, and after drying, you will get the cooked Rehmannia root.

[0022] Preparation method of roasted licorice root: take roasted licorice root slices, put them in 25% honey by weight, stir evenly, make the roasted licorice root slices fully soaked in honey, let it sit for 30-60 minutes to allow the honey to be completely absorbed; then put the soaked roasted licorice root slices into a pot, heat with low heat, stir constantly, and stir-fry until the surface is old yellow, not sticky and has an aroma, then take it out of the pot immediately, spread it out and place it in a ventilated and dry place, cool it, sieve out the debris, and you will get roasted licorice root.

[0023] (III) Beneficial effects The Chinese medicine formula of the present invention is based on the holistic treatment concept of attacking and supplementing at the same time, harmonizing qi and blood, harmonizing yin and yang, coordinating the five flavors, treating viscera and harmonizing qi, avoiding the problems of the traditional prescriptions with strange medicinal properties, single prescription efficacy, warm and dry damage to yin, complex medicinal flavors and lack of pertinence. The Chinese medicine composition of the present invention is in line with the pathogenesis and characteristics of COPD, and takes into account the overall situation and peace, so as to achieve the dynamic balance of yin and yang, qi and blood, and viscera functions of the human body, and finally realize the healthy state of "yin and yang balance". Through the synergistic effect of multiple medicines, the present invention can not only improve the symptoms of COPD patients, but also regulate body functions and restore a healthy state, which is a profound embodiment of the overall harmony and dynamic balance concept of traditional Chinese medicine.

[0024] The Chinese medicine composition of the present invention achieves a balance between invigorating qi and nourishing yin and promoting blood circulation and unblocking collaterals. Roasted Astragalus membranaceus is combined with Codonopsis pilosula to invigorate qi, strengthen the qi of the lungs and spleen, and increase the strength of invigorating qi. Rehmannia glutinosa, Cornus officinalis, and Ophiopogon japonicus work together to nourish kidney yin and moisten lung dryness, making up for the deficiency of existing formulas that warm and dry and damage yin. The combination of earthworm and Rhizoma Dioscoreae can improve pulmonary microcirculation and solve the core pathogenesis of COPD in a targeted manner. Cornus officinalis strengthens the kidney and Ophiopogon japonicus moistens the lungs, which are in line with the pathological characteristics of COPD "long-term illness and kidney, lung and kidney deficiency"; Morus alba bark clears the lungs and resolves phlegm, Platycodon grandiflorum promotes lung function and discharges phlegm, and Rhizoma Dioscoreae unblocks collaterals and relieves asthma, targeting the pathogenesis of "mutual stagnation of phlegm and blood stasis, and obstruction of collaterals by phlegm and blood stasis".

[0025] The Chinese medicine composition of the present invention does not contain rare protected animal-derived medicinal materials and honey (contraindicated for diabetes), has abundant sources of medicinal materials, and is cost-controllable. Calcined purple quartz is combined with high-temperature calcination and vinegar quenching, and has low fluoride toxicity; Elaeagnus root contains quercetin, which has anti-inflammatory effects and may enhance the antiasthmatic effect. A higher dose of Rhizoma Dioscoreae exerts anti-inflammatory and immunomodulatory effects, and exerts a collateral-draining effect. When the heat syndrome is obvious, Houttuynia cordata and Morus alba bark are combined to clear lung heat. The Chinese medicine composition of the present invention is particularly suitable for the stable stage of COPD with deficiency of both lung and kidney qi and yin and phlegm and blood stasis (symptoms include shortness of breath and fatigue, wheezing when moving, dry cough with little sputum, and soreness of waist and knees).

[0026] In summary, the present invention improves the efficacy and safety of the drug by balancing tonic and expectorant and promoting blood circulation, and taking both tonic and eliminating effects. DETAILED DESCRIPTION

[0027] The present invention discloses a Chinese medicine composition for improving the symptoms of stable chronic obstructive pulmonary disease, which is prepared from a medicinal material composition comprising the following components: 13-17 parts of roasted astragalus, 13.5-16.5 parts of codonopsis, 9-11 parts of cooked rehmannia, 13.5-16.5 parts of cornus, 9-11 parts of white mulberry bark, 9-11 parts of platycodon, 5-7 parts of roasted licorice, 5-7 parts of earthworm, 27-33 parts of rhizoma scutellariae, 16-18 parts of elaeagnus root, 7-9 parts of calcined purple quartz and 13.5-16.5 parts of ophiopogon. The monarch drugs are roasted astragalus and codonopsis, the minister drugs are cooked rehmannia, cornus, purple quartz and ophiopogon; the adjuvant drugs are earthworm, rhizoma scutellariae, elaeagnus root, white mulberry bark and platycodon; and the guiding drug is roasted licorice.

[0028] Main medicine: Roasted Astragalus is sweet and warm, enters the lung and spleen meridians, greatly replenishes the qi of the lung and spleen, has the effects of protecting the skin surface, resisting external evil, raising yang qi and helping the circulation of qi and blood, and is an important medicine for replenishing the lung and spleen. Codonopsis is sweet and mild in nature, good at replenishing the qi of the spleen and stomach, and can benefit the lung qi, nourish blood and produce body fluid. When used together with roasted Astragalus, they can jointly play the effect of strengthening the spleen and benefiting the lungs, nourish the acquired foundation, make the qi and blood biochemical active, thereby nourishing the lung qi, and become the cornerstone of strengthening the body. After processing, the qi-replenishing effect of Astragalus is enhanced, and when used in combination with Codonopsis, it can significantly improve the effect of tonifying the spleen and benefiting the lungs.

[0029] Ministerial drugs: Rehmannia glutinosa is sweet and warm in nature, and has the effects of nourishing yin and blood, replenishing essence and benefiting marrow. Its main function is to nourish kidney yin and enrich kidney essence and qi, and it is an important medicine for nourishing kidney. Cornus officinalis tastes sour, astringent and slightly warm, and its function is to nourish liver and kidney and consolidate essence and qi. Amethyst belongs to the lung and kidney meridians, and its nature is sweet and warm. It can warm the kidney and assist yang, warm the lung and relieve asthma. By warming yang, it promotes the dissipation of phlegm and blood stasis, prevents the nourishment of greasy evil, and seeks yang in yin, so that yang is assisted by yin and infinite biochemical, and more effectively plays the role of warming the kidney and absorbing qi. Ophiopogon japonicus is sweet and slightly cold in nature, and belongs to the lung, heart, and stomach meridians. It has the effects of nourishing yin and moistening lungs, benefiting stomach and producing body fluids. It can nourish lung yin and avoid the excessive warming and dryness of yang-tonifying drugs. The various drugs cooperate with each other to achieve the whole prescription of yin and yang, moisturizing and dryness, and neither dryness nor greasy.

[0030] Adjuvant: Earthworm is salty and cold in nature, and belongs to the lung meridian. It has the effects of promoting blood circulation and relieving asthma, which helps to improve the stagnation of qi and blood in the lungs and relieve bronchospasm and wheezing symptoms. Rhizoma Dioscoreae is bitter and warm in nature, and enters the lung meridian. It can promote blood circulation and dredge collaterals, dispel wind and dampness, and relieve cough and asthma. When used together with purple quartz, it can "harmonize the lungs and kidneys", which not only treats superficial symptoms such as cough and asthma, but also fundamentally warms the kidneys and consolidates the body. Elaeagnus root is flat in nature, good at astringing lung qi, relieving cough and asthma, dispelling wind and dampness. The quercetin contained in Elaeagnus root inhibits the release of histamine and relieves bronchospasm. It is especially suitable for long-term cough and weak lungs. At the same time, Elaeagnus root has antibacterial effects, including inhibition of respiratory tract infection bacteria (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae) and representative Gram-positive bacteria (Bacillus subtilis). Morus alba bark is sweet and cold in nature, and specifically enters the lung meridian. It can relieve lung and asthma, promote diuresis and reduce swelling, and help restore the normal function of the lung. Platycodon grandiflorum is pungent, dispersing, bitter and purging, and can open and clear lung qi, remove phlegm and relieve sore throat. It can also carry drugs upward and guide drugs directly to the diseased area, that is, the lung meridian. Pheretima and Rhizoma Dioscoreae are used together to dredge meridians and relieve asthma, promote blood circulation and resist fibrosis. Morus alba bark is used together with Platycodon grandiflorum to clear lung and resolve phlegm, and the ascending and descending are caused by each other. Elaeagnus radix and Morus alba bark are used together to relieve cough and asthma, and have anti-inflammatory and antioxidant effects. Morus alba bark alone is not strong enough to clear lung heat in the prescription. If the patient has yellow and thick phlegm and fever, it needs to be combined with Houttuynia cordata to strengthen heat clearing.

[0031] Assistant drug: Roasted licorice root is sweet and mild in nature, and can harmonize various drugs and alleviate the medicinal properties of other drugs, ensuring that the entire prescription is nourishing without stagnation, attacking without hurting the body, and synergistically exerting the effects of nourishing the lungs, strengthening the spleen and kidneys, removing phlegm and removing blood stasis, and relieving asthma and cough.

[0032] The Chinese medicine composition of the present invention fully implements the principles of strengthening the body and eliminating evil, treating both the symptoms and the root causes, taking into account both yin and yang, combining movement and stillness, and harmonizing the organs, and the medicinal properties are mild. The prescription is dominated by strengthening the body, supplemented by eliminating evil, and through the method of attacking and replenishing, not only replenishes the deficiency of the human body, but also drives out the evil, avoids the stagnation of phlegm and turbidity that may be caused by simple replenishment, or only focuses on the damage caused by eliminating evil to the healthy qi, and perfectly embodies the treatment concept of "strengthening the body and eliminating evil" in traditional Chinese medicine. In terms of drug compatibility, the medicinal materials of nourishing yin and blood and nourishing qi and warming yang cooperate with each other, aiming to reconcile the yin and yang qi and blood in the human body, and restore the balanced state of body qi, blood, yin and yang. This prescription starts from the lung, spleen, and kidney, not only replenishes the qi of the lung and spleen, but also nourishes kidney yin, warms and replenishes kidney yang, focuses on overall regulation, and achieves the goal of treating the organs together. Through the method of combining movement and stillness, adjusting cold and heat, taking into account the five flavors, and attacking and replenishing, the bias of the medicinal properties is prevented, the overall peace of the prescription is guaranteed, and it is suitable for long-term use for conditioning, thereby achieving the purpose of optimizing health status.

[0033] The significant advantages of the Chinese medicine composition of the present invention are as follows: 1. Multi-target comprehensive treatment to treat both the symptoms and the root causes; By carefully selecting a variety of medicinal materials for combination, we have achieved the therapeutic effects of nourishing the lungs, spleen, and kidneys, as well as removing phlegm and blood stasis, relieving asthma and cough, etc., regulating the body's functions as a whole and improving the symptoms of the disease.

[0034] 2. Strengthen the body and eliminate evil, attack and supplement at the same time; With roasted Astragalus and Codonopsis as the main drugs, their main function is to greatly replenish the qi of the lungs and spleen; the auxiliary drugs such as Rehmannia glutinosa, Cornus officinalis, Amethyst and Ophiopogon japonicus are used to nourish the lungs, spleen and kidneys, and further enhance the body's positive qi. The adjuvant drugs of earthworms and Rhizoma Dioscoreae can promote blood circulation, dredge collaterals and relieve asthma, Elaeagnus root can astringe lung qi and relieve cough, Morus alba bark can purge the lungs and relieve asthma, and Platycodon grandiflorum can open up lung qi and eliminate phlegm, and play a role in expelling evil in the phenomenon of phlegm and blood stasis blocking the lungs. This design not only consolidates the root and eliminates the superficial symptoms, but also achieves the therapeutic effect of attacking and replenishing, which is particularly suitable for cases with a long course of disease and mixed deficiency and excess.

[0035] 3. Supplement both yin and yang; Among the ministerial drugs, Rehmannia glutinosa and Cornus officinalis nourish Yin, Amethyst warms Yang, and Ophiopogon japonicus nourishes Yin and moistens dryness. All the drugs are matched to supplement kidney Yang on the basis of nourishing Yin, promote the mutual growth and restriction of Yin and Yang in the kidney, and achieve a state of Yin and Yang balance. This compatibility strategy embodies the concept of "those who are good at replenishing Yin must seek Yin in Yang, so that Yin can be raised by Yang and the source is inexhaustible", while avoiding the problem of excessive warming and dryness of simple Yang-replenishing drugs, and jointly achieve the effect of replenishing Yin and Yang, so that the whole prescription replenishes without being dry, and nourishes without being greasy.

[0036] 4. Harmony of Qi and blood; In view of the principle that "qi is the leader of blood, and blood is the mother of qi", the composition regulates the dynamic balance of qi and blood by replenishing qi and activating blood circulation, nourishing yin and regulating qi, etc. Roasted Astragalus, Codonopsis, and Purple Quartz replenish the qi of the lungs, spleen, and kidneys, and when qi is sufficient, blood will be activated; Rhizoma Dioscoreae and Pheretima can activate blood circulation and dissipate blood stasis; Rehmannia glutinosa, Ophiopogon japonicus, and Fructus Corni can nourish yin and replenish blood; Platycodon grandiflorum and Morus alba can promote the flow of qi and descend the lungs, harmonize qi, and ensure that qi and blood flow smoothly.

[0037] 5. Combination of movement and stillness; The combination of tonic herbs and blood-activating herbs can both maintain the body's health statically and promote circulation dynamically. The main method is to replenish qi, supplemented by promoting blood circulation and removing blood stasis, ensuring that qi replenishment will not cause qi and blood stagnation, and effectively improving the state of phlegm and blood stasis blocking the lungs.

[0038] 6. Treat all internal organs at the same time; Taking into account the characteristics of the disease gradually affecting the spleen and kidney from the lungs, this prescription uses precise medication to achieve simultaneous treatment of the three organs of the lungs, spleen and kidneys. Through the effects of different medicinal materials, the different needs of the lungs, spleen and kidneys are supplemented respectively, realizing the application of the "holistic concept" and "simultaneous treatment" ideas of traditional Chinese medicine.

[0039] 7. Harmonize the medicinal properties; By using both cold and warm ingredients, the whole prescription is neither too warm nor too cold, which is in line with the core concept of TCM "balance". At the same time, licorice is used to reconcile the various drugs to ensure the balance of the medicinal properties, so that the whole prescription is tonic but not harsh, aggressive but not fierce, and the medicinal effect is gentle and orderly. Finally, through the design of the harmony of the five flavors and the orderly rise and fall of the medicinal flavors, a harmonious state of "yin and yang are balanced, and the spirit is cured" is achieved.

[0040] In order to better explain the present invention, for easy understanding, the following is a detailed description in conjunction with specific examples and clinical trials. Unless otherwise specified, the medicinal materials and reagents involved in the embodiments of the present invention are all commercially available products and can be purchased through commercial channels. The raw materials used in the basic formula all meet the requirements of the "Pharmacopoeia of the People's Republic of China 2020 Edition" published by China Medical Science and Technology Press.

[0041] Example 1 The present embodiment provides a traditional Chinese medicine decoction for improving the symptoms of stable chronic obstructive pulmonary disease, wherein the medicinal materials are: 15g of roasted astragalus, 15g of codonopsis pilosula, 10g of cooked rehmannia, 15g of cornus officinalis, 10g of mulberry bark, 10g of platycodon, 6g of roasted liquorice, 6g of earthworm, 30g of rhizoma schizonepetae, 17g of elaeagnus root, 8g of calcined purple quartz and 15g of ophiopogon.

[0042] The preparation method of the Chinese medicine decoction is as follows: the medicinal materials are weighed according to the components of the medicinal material composition, the floating soil is washed with clean water, and after drying, the medicinal materials are sterilized by microwave; the Rhizoma Dioscoreae is soaked in 50°C warm water for 15 minutes to soften the fibers, and then the roasted Astragalus, Codonopsis and Rhizoma Dioscoreae are cut into 3-5 mm thick slices; the earthworm is dried to a water content of ≤8%, and after being crushed, it is soaked in 70-75% ethanol for 20 minutes, and the ethanol is filtered out; the calcined purple quartz is first put into water and boiled for 30 minutes, and then all the remaining medicinal materials are put into water and soaked for 30 minutes, water is added to exceed the medicinal surface by 2-3 cm, the first boiling is for 20 minutes, 1 / 2 of the medicinal liquid is poured out, and warm water is added for the second boiling for 25 minutes, all the medicinal liquid is poured out, the two medicinal liquids are combined and mixed, and the Chinese medicine decoction is obtained, which is one dose and is taken twice a day, morning and evening.

[0043] Example 2 This embodiment provides a Chinese medicine decoction for improving the symptoms of stable chronic obstructive pulmonary disease, wherein the medicinal materials are: 16g of roasted Astragalus, 16g of Codonopsis, 9g of Rehmannia, 14g of Cornus, 10g of Morus alba, 10g of Platycodon, 7g of roasted Licorice, 5g of Pheretima, 32g of Rhizoma Dioscoreae, 18g of Elaeagnus root, 9g of Amethyst and 16.5g of Radix Ophiopogonis. The preparation method of the decoction is the same as that of Embodiment 1.

[0044] Example 3 The present embodiment provides a Chinese medicine decoction for improving the symptoms of stable chronic obstructive pulmonary disease, wherein the medicinal materials are: 17g of roasted Astragalus, 16.5g of Codonopsis, 10g of Rehmannia, 16.5g of Cornus, 10g of Morus alba, 10g of Platycodon grandiflorum, 14g of Houttuynia cordata, 5g of roasted Licorice root, 6g of Pheretima, 30g of Rhizoma Dioscoreae, 17g of Elaeagnus root, 8g of Amethyst and 15g of Radix Ophiopogonis. The preparation method of the decoction is the same as that of the embodiment 1. The Chinese medicine decoction of the present embodiment is aimed at patients with yellow and thick sputum and obvious fever, so as to assist Morus alba and Platycodon grandiflorum in clearing away heat and controlling heat symptoms.

[0045] Example 4 The present embodiment provides a Chinese medicine powder for improving the symptoms of stable chronic obstructive pulmonary disease, wherein the medicinal raw materials are: 17g of roasted astragalus, 16g of codonopsis, 11g of cooked rehmannia, 14g of cornus, 9g of mulberry bark, 9g of platycodon, 6g of roasted liquorice, 7g of earthworm, 33g of rhizoma spatholobi, 16g of root of elaeagnus officinalis, 8g of calcined purple quartz and 14g of ophiopogon.

[0046] The preparation method of Chinese medicine powder is as follows: Step 1: Rinse the medicinal materials with clean water to remove the floating soil. After drying, perform microwave sterilization (2450MHz, 3 minutes). This has a high sterilization rate and replaces the traditional multiple water washing to reduce the loss of water-soluble components.

[0047] Step 2: Soak the Rhizoma Dioscoreae in 50℃ warm water for 10 minutes to soften the fibers, then cut the roasted Astragalus, Codonopsis and Rhizoma Dioscoreae into 3-5mm thick slices; crush the calcined purple quartz into 80 mesh fine powder; bake the earthworm until the moisture content is ≤8%, and after crushing, soak it in 70% ethanol for 20 minutes to inactivate enzymes and reduce the fishy smell, and then filter to remove the ethanol.

[0048] Step 3: all the medicinal material compositions were mixed with 8 times the mass of water, 5wt% of rice vinegar was added to the water, and after pre-soaking for 0.5h, the temperature was raised to 90°C for 30min, and stirred simultaneously, and the temperature was lowered to 70°C, 0.1% cellulase (w / w) was added, and enzymolysis was performed for 60min. During the extraction process, a condensation reflux device was connected to the top of the extraction tank to collect the volatile components of Morus alba and Platycodon grandiflorum, and the collected condensate was finally added back to the medicinal solution; Step 4: Concentrate the extract under the conditions of vacuum degree -0.08MPa and temperature of 60°C to obtain a concentrated paste with a relative density of 1.30 at 70°C; Step 5: Mix the concentrated paste with dextrin and microcrystalline cellulose in a mass ratio of 1:0.9:0.3, and pass through a centrifugal spray drying tower (inlet air temperature 160°C, outlet air temperature 85°C) to make a granular powder with a mesh size of 80 and a moisture content of ≤5%. Divide the powder into two bags and take one bag each morning and evening with warm water.

[0049] Example 5 This embodiment provides a Chinese medicine powder for improving the symptoms of stable chronic obstructive pulmonary disease, and its raw materials are: 13g of roasted Astragalus, 13.5g of Codonopsis, 11g of Rehmannia, 13.5g of Cornus, 11g of Morus alba, 11g of Platycodon, 7g of roasted Licorice, 5g of Pheretima, 32g of Rhizoma Dioscoreae, 16g of Elaeagnus root, 7g of Calcined Amethyst and 13.5g of Radix Ophiopogonis. The preparation method of the Chinese medicine powder is the same as that of Example 4. The powder prepared according to the above prescription in this embodiment is packaged into two bags, and one bag is taken with warm water in the morning and evening.

[0050] Comparative Example 1 In this comparative example, the "purple quartz" in the ministerial drug and the "root of Elaeagnus chinensis" in the adjuvant drug are removed from the medicinal material components of Example 1, and the other components remain unchanged. After the ministerial drug of this comparative example lacks purple quartz, the overall prescription tends to be warm and dry; after the adjuvant drug lacks "root of Elaeagnus chinensis", the efficacy of the chronic cough syndrome of lung deficiency is weakened. According to the method of Example 1, a Chinese medicine decoction for relieving cough is obtained.

[0051] Clinical trials 1. General information and case sources: A total of 120 patients with COPD admitted to the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 1, 2021 to December 31, 2023 were collected as research subjects.

[0052] 2. Diagnostic criteria: 1. Western medicine diagnostic criteria: Refer to the diagnostic criteria for COPD in the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)": ① History of smoking, exposure to biomass fuels, air pollution and other risk factors or host factors; ②History of recurrent lower respiratory tract infection; ③The main symptoms are dyspnea, chronic cough or sputum; ④ Pulmonary function test: FEV1 / FVC < 0.7 after using bronchodilator; ⑤After excluding other diseases, COPD can be diagnosed according to ①②③④.

[0053] 2. TCM diagnostic criteria: Refer to the diagnostic criteria for lung-kidney qi-yin deficiency syndrome in the "Guidelines for TCM Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2019 Edition)" formulated by the Chinese Association of Traditional Chinese Medicine. Main symptoms: ① wheezing and shortness of breath, aggravated by movement; ② spontaneous sweating or fatigue, aggravated by movement; ③ easy to catch cold; ④ soreness of waist and knees; ⑤ tinnitus, dizziness or dizziness; Secondary symptoms: ① dry cough or little sputum, uncomfortable sputum; ② night sweats; ③ hot palms and soles; ④ pale or red tongue, thin or mottled tongue coating, or deep, thin, weak or fine pulse.

[0054] If two of the main symptoms ①, ②, and ③ are present, plus one of ④ and ⑤, plus two of the secondary symptoms are present, the patient can be diagnosed with deficiency of both lung and kidney qi and yin.

[0055] III. Inclusion criteria: 1. COPD patients who meet the diagnostic criteria of Western medicine; 2. Patients who meet the TCM diagnosis of COPD with deficiency of both lung and kidney qi and yin; Any of the above 1 and 2 is met; 3. Age 40 ≤ ≤ 85 years old, regardless of gender; 4. Those who are tolerant to the drugs and treatment methods designed in this study; voluntarily participate in this clinical study and sign the informed consent.

[0056] IV. Exclusion criteria: 1. Have other serious primary organic diseases, or serious complications of heart, liver, kidney, etc.; 2. Suffering from other diseases that cause coughing and wheezing, such as tuberculosis, lung cancer, bronchiectasis, pulmonary interstitial fibrosis, etc.; 3. Those with a history of allergy to drugs used in this study; 4. Pregnant and lactating women; 5. Suffering from mental disorders, cognitive impairment and other diseases; 6. Currently participating in other trials or researchers.

[0057] 5. Elimination, falling off and termination standards: 1. Patients with poor compliance and who do not strictly follow the prescribed treatment, thus affecting the efficacy assessment; 2. The statistical or evaluation data are missing or wrong, which affects the efficacy assessment; 3. Other diseases that may affect treatment during the trial; 4. Patients with severe adverse reactions during the trial; 5. Those who develop other serious complications or whose condition worsens during the trial and may suffer dangerous events.

[0058] 6. Test methods: 1. Grouping method: The research subjects were divided into two groups, the treatment group was recorded as group A and the control group was recorded as group B.

[0059] A total of 120 cases were collected in this trial, but due to follow-up and other reasons, only 108 cases completed the trial, and a total of 108 patients were included.

[0060] (II) Treatment methods: 1. General treatment: Basic treatment is given, including disease-related education, low-salt and low-fat diet, smoking cessation and alcohol restriction, moderate exercise, avoidance of wind and cold, emotional regulation, and careful daily life.

[0061] 2. Drug treatment: Conventional treatment and standardized Western medicine treatment refer to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)". The specific dosage plan is: budegol inhalation aerosol: 2 inhalations each time, twice a day; or salmeterol fluticasone powder inhalation / aerosol: 1 inhalation each time, twice a day.

[0062] The treatment group was treated with the traditional Chinese medicine decoction for improving the symptoms of chronic obstructive pulmonary disease in stable stage according to the present invention on the basis of the above conventional western medicine treatment. The prescription is shown in Example 1.

[0063] The control group was treated with the Chinese medicine decoction of comparative example 1 plus oral administration on the basis of the above conventional western medicine treatment. The above two prescriptions were decocted into decoctions by the Chinese medicine pharmacy of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, 2 bags per dose, 150ml / bag. Usage: One dose per day, warm and take half an hour after meals in the morning and evening.

[0064] For both groups, 14 days constituted one course of treatment, with a total of 1 course of treatment.

[0065] 3. Observation indicators: 1. Safety indicators: Body temperature, heart rate, blood pressure, pulse, blood routine, liver and kidney function, electrolytes, blood lipids, urine and stool routine tests (one test before and after treatment); Observe possible adverse reactions, including local skin reactions and systemic reactions, such as general rashes, allergic reactions, and gastrointestinal reactions. Pay attention to analyzing the causes of adverse reactions, make accurate judgments in a timely manner, and truthfully record the treatment process and results; 2. Efficacy indicators: 1) TCM syndrome scoring standard: According to the TCM syndrome scoring scale: cough, sputum, and wheezing are assigned different scores according to absence, mild, moderate, and severe as the main symptoms, from low to high, 0, 2, 4, and 6 points respectively. Fever, thirst, yellow and red urine, and dry stool are scored as 0, 1, 2, and 3 points according to absence, mild, moderate, and severe. The tongue and pulse are recorded truthfully and are not used as scoring items. The patients are informed of the TCM syndrome scores in detail, and the researchers collect the changes in the patients' symptoms before and after treatment.

[0066] 2) Criteria for judging the efficacy of Western medicine: ①mMRC dyspnea score; ② COPD CAT assessment test; ③ Pulmonary function indicators: FEV1 / FVC, percentage of FEV1 to predicted value.

[0067] ④ Six-minute walk distance (6MWD) mainly records the patient's activity distance within six minutes and tests the patient's exercise endurance. It is recorded once before and after treatment. The patient should be informed of the test content and precautions in detail before the test.

[0068] 3) Criteria for determining efficacy The efficacy determination criteria are determined in accordance with the 2002 edition of the Guiding Principles for Clinical Research of New Chinese Medicines, as follows: ①Clinical control: clinical symptoms and signs disappear or basically disappear, and the reduction rate of TCM syndrome score is ≥95%; markedly effective: ② Significantly effective: clinical symptoms and signs are significantly improved, and the reduction rate of TCM syndrome score is ≥70% and <95%; ③ Effective: clinical symptoms and signs have improved, and the reduction rate of TCM syndrome score is ≥30% and <70%; ④ Ineffective: clinical symptoms and signs have not been significantly improved, or even aggravated, and the reduction rate of TCM syndrome score is less than 30%; The reduction rate of TCM syndrome scores in the above efficacy judgment criteria was calculated using the nimodipine method, and the calculation formula was: reduction rate of TCM syndrome scores = [(total syndrome score before treatment - total syndrome score after treatment) / total syndrome score before treatment] × 100%.

[0069] 7. Statistical analysis SPSS 26.0 software was used to input and analyze the data. For quantitative data, mean ± standard deviation was used. Data description was performed. For data that met normal distribution and homogeneity of variance, paired sample t-test and Wilcoxon signed rank test were used for intra-group comparison; otherwise, rank sum test was used. Count data were expressed as frequency or percentage (%), and chi-square test was used for inter-group comparison. For rank data, rank sum test was used for inter-group comparison. When P < 0.05, the difference between the two groups of data was considered statistically significant.

[0070] 8. Research Results: 1. Comparison of gender between the two groups of patients: A total of 108 patients were included in this study, including 54 males and 54 females. There were 55 patients in the treatment group, including 29 males (52.73%) and 26 females (47.27%). There were 53 patients in the control group, including 25 males (47.17%) and 28 females (52.83%). The X2 test showed that X2=0.016, P=0.992>0.05, indicating that there was no statistically significant difference in gender between the two groups of patients, indicating that the gender data of the two groups were comparable. See Table 1.

[0071] Table 1: Gender comparison of the two groups of patients: .

[0072] 2. Age comparison between the two groups of patients: The age of the two groups of patients was compared. The oldest patient in the treatment group was 86 years old, the youngest was 51 years old, and the average age was 69.65±7.86 years old; the oldest patient in the control group was 86 years old, the youngest was 53 years old, and the average age was 71.9±7.30 years old. The rank sum test showed that P=0.122>0.05, indicating that there was no statistically significant difference in the age of the two groups of patients, indicating that the age data of the two groups were comparable. See Table 2.

[0073] Table 2: Comparison of age between the two groups of patients: .

[0074] 3. Comparison of TCM syndrome scores of patients before and after treatment: Comparison of intra-group data: After treatment, the TCM syndrome scores of both groups were reduced. The t-test showed that the treatment group t=10.319, P<0.001, and the control group t=16.162, P<0.001, indicating that there was a statistically significant difference in the TCM syndrome scores of the two groups before and after treatment, suggesting that the interventions in both groups were effective.

[0075] Comparison of intergroup data: The t-test showed that the difference in TCM syndrome scores between the two groups before treatment was t=0.016, P>0.05, which was not statistically significant, indicating that the TCM syndrome scores of the two groups before treatment were comparable; the difference in TCM syndrome scores between the two groups after treatment was t=-3.49, P=<0.05, which was statistically significant, indicating that the treatment group was more effective in improving TCM syndromes than the control group. See Table 3.

[0076] Table 3: Comparison of TCM syndrome scores between the two groups of patients before and after treatment (points): .

[0077] 4. Comparison of mMRC dyspnea scores between the two groups of patients before and after treatment: Comparison of intra-group data: After treatment, the mMRC dyspnea scores of both groups of patients were reduced. The t-test showed that the treatment group t=14.152, P<0.001, and the control group t=14.565, P<0.001, indicating that the difference in mMRC scores between the two groups of patients before and after treatment was statistically significant, suggesting that the interventions in both groups were effective.

[0078] 001 Comparison of intergroup data: The t-test showed that the difference in mMRC dyspnea scores between the two groups before treatment was t=0, P>0.05, which was not statistically significant, indicating that the mMRC dyspnea scores of the two groups before treatment were comparable; the difference in mMRC dyspnea scores between the two groups after treatment was t=-6.21, P=<0.001, which was statistically significant, indicating that the treatment group was more effective in improving the mMRC dyspnea scores of patients than the control group. See Table 4 for details.

[0079] Table 4: Comparison of mMRC scores between the two groups of patients before and after treatment (points): .

[0080] 5. Comparison of CAT scores in patients with COPD assessment test: Comparison of intra-group data: After treatment, the CAT scores of both groups decreased. The t-test showed that the treatment group t=8.30, P<0.001, and the control group t=7.0, P<0.001, indicating that the difference in CAT scores between the two groups of patients before and after treatment was statistically significant, suggesting that the interventions in both groups were effective.

[0081] Comparison of intergroup data: The t-test showed that the difference in CAT scores between the two groups before treatment was t=0, P>0.05, which was not statistically significant, indicating that the CAT score data of the two groups before treatment were comparable; the difference in CAT scores between the two groups after treatment was t=-16.27, P=<0.05, which was statistically significant, indicating that the treatment group had a more obvious effect on improving the CAT scores of patients than the control group. See Table 5 for details.

[0082] Table 5: Comparison of CAT scores in patients with COPD assessment test (points) .

[0083] 6. Comparison of forced expiratory volume in one second (FEV1) levels between the two groups of patients before and after treatment (%): Comparison of intra-group data: After treatment, the FEV1 levels of both groups of patients increased. The rank sum test showed that the treatment group Z=-6.49, P<0.001, and the control group Z=-6.458, P<0.001, indicating that the difference in FEV1 levels between the two groups of patients before and after treatment was statistically significant, suggesting that both interventions were effective.

[0084] Comparison of data between the groups: by t-test, the difference in FEV1 levels between the two groups of patients before treatment was t=0.17, P>0.05, which was not statistically significant, indicating that the FEV1 data of the two groups before treatment were comparable; the difference in FEV1 levels between the two groups of patients after treatment was t=4.8, P=<0.05, which was statistically significant, indicating that the treatment group was more effective in improving the FEV1 of patients than the control group. For details, see Table 6.

[0085] Table 6: Comparison of forced expiratory volume in one second (FEV1) between the two groups of patients before and after treatment (L / S): .

[0086] 7. Comparison of FEV1 / FVC levels between the two groups of patients before and after treatment: Comparison of intra-group data: After treatment, the FEV1 / FVC levels of both groups of patients were improved. The rank sum test showed that the treatment group Z=-8.58, P<0.001, and the control group Z=-4.775, P<0.001, indicating that the difference in FEV1 / FVC levels between the two groups of patients before and after treatment was statistically significant, suggesting that both interventions were effective.

[0087] Comparison of data between the groups: by t-test, the difference in FEV1 / FVC levels between the two groups of patients before treatment was t=-0.137, P>0.05, which was not statistically significant, indicating that the FEV1 data of the two groups before treatment were comparable; the difference in FEV1 / FVC levels between the two groups of patients after treatment was t=2.69, P=<0.05, which was statistically significant, indicating that the treatment group was more effective in improving the FEV1 / FVC of patients than the control group. For details, see Table 7.

[0088] Table 7: Comparison of FEV1 / FVC between the two groups of patients before and after treatment (%): .

[0089] 8. Comparison of six-minute walking distance (6MWD) levels between the two groups of patients before and after treatment: Comparison of intra-group data: After treatment, the 6MWD levels of both groups were improved. The t test showed that the treatment group t=-18.481, P<0.001; the control group Z=-13.149, P=<0.001, indicating that the difference between the 6MWD levels of the two groups before and after treatment was statistically significant, suggesting that the interventions in both groups were effective. Comparison of inter-group data: One-way ANOVA showed that there was no statistically significant difference in the 6MWD levels of the two groups before treatment (t=0.038, P>0.05), indicating that the 6MWD data of the two groups before treatment were comparable; the rank sum test showed that the difference in the 6MWD levels of the two groups after treatment was statistically significant (z=2.58, P<0.001), indicating that the treatment group had a more significant effect on improving the 6-minute walking distance level of patients than the control group. See Table 8.

[0090] Table 8: Comparison of six-minute walking distance (6MWD) between the two groups of patients before and after treatment: .

[0091] 9. Patient Outcomes After the treatment of this study was completed, there were 55 patients in the treatment group, of which 8 were clinically controlled, 25 were markedly effective, 19 were effective, and 3 were ineffective, with a total effective rate of 94.55%; there were 53 patients in the control group, of which 6 were clinically controlled, 23 were markedly effective, 15 were effective, and 9 were ineffective, with a total effective rate of 83.02%. The chi-square test was used to analyze the total effective rate of the two groups, and the chi-square test gave H c =8.941, P<0.001, indicating that there was a statistically significant difference in the total effective rate between the two groups, suggesting that the total effective rate of the treatment group was higher than that of the control group. For details, see Table 9.

[0092] Table 9: Comparison of clinical efficacy: .

[0093] Note: Total effective rate (%) = (clinical control + marked effect + effectiveness) / number of patients × 100%.

[0094] 10. Safety assessment: (1) Drug safety assessment: Before, during and after treatment, both groups of patients underwent routine examinations of vital signs, blood, urine, and stool, as well as liver and kidney function, electrocardiogram and other tests to evaluate the safety of the drug. No normal results before treatment were found but abnormal results after treatment, indicating that the drug is safe.

[0095] (2) Adverse reactions of patients: Only 2 cases experienced adverse reactions during the period, and both cases improved after symptomatic treatment.

[0096] Typical treatment cases Case 1: Patient 1, 60 years old, male, married, complained of “recurrent cough and asthma for more than 10 years”.

[0097] Current medical history: chest tightness and shortness of breath for 10 years, now occasionally coughs after catching a cold, without sputum, chest tightness and shortness of breath have improved significantly compared with before, occasionally feels general weakness, no obvious dryness and bitterness in the mouth, no back pain, no dizziness or headache, fear of cold, normal bowel movements, good appetite and sleep, dark red tongue with white coating and cracks, slightly tortuous sublingual veins, and thin pulse.

[0098] Previous examinations and tests: On October 17, 2023, a chest CT scan at an external hospital revealed emphysema, scattered chronic inflammation and hyperplasia in the left lung, which was similar to the previous one, and a 0.5*1cm nodule shadow was seen in the left lower lung. On August 8, 2022, the lung function test at an external hospital showed: pulmonary function after diastole: severe decrease in pulmonary ventilation function (mixed); severe decrease in lung diffusion function; FeNO: 35ppb. On April 5, 2023, a chest CT scan at an external hospital showed: changes in chronic bronchitis and emphysema; scattered chronic inflammation in the left lung; a 0.5*1cm nodule in the left lower lung.

[0099] Pulmonary function: April 26, 2023: VCmax (2.32, 57%); FVCex (2.32, 59%); FEV1 (1.04, 34%); FEV1 / VCmax (45, 56%); FEV1 / FVCex (45, 56%); MVV (43, 39%) Extremely severe mixed ventilation dysfunction; decreased maximum ventilation volume; decreased pulmonary diffusion function; increased residual-to-total ratio; increased airway resistance; decreased respiratory muscle strength; negative bronchial dilation test.

[0100] Past history, personal history, family history, etc.: History of chronic obstructive pulmonary disease, controlled by Budeglobose regularly. Smoked for 40 years, 1 pack / day, now quit smoking for 6 years; the condition often relapses. No history of diabetes, heart disease and hypertension; denies history of drug and food allergies; denies family history of genetic diseases.

[0101] Auxiliary examination: body temperature (T) 37.3℃, heart rate (P) 100 times / min, respiration (R) 21 times / min, blood pressure (BP) 112 / 89mmHg. Barrel chest, a small amount of moist rales were heard in both lungs.

[0102] The patient is an elderly male with cough, wheezing, and chest tightness. Due to long-term damage to lung qi, the lung's function of controlling qi and breathing is abnormal, resulting in lung qi deficiency and lung failure to descend. Lung qi deficiency is unable to promote blood circulation, blood circulation is slow, and blood stasis is formed, so the tongue is dark red and the veins under the tongue are slightly tortuous. At the same time, the lung fails to descend, and the distribution of body fluids is abnormal, gathering to form phlegm. Phlegm and blood stasis are intertwined and blocked in the lung network, resulting in poor lung qi and aggravated chest tightness and wheezing. Overall, the patient has lung qi deficiency and lung and kidney deficiency as the root, and the symptoms are the feeling of external evil and phlegm turbidity and blood stasis. In the stable stage of the disease, the main deficiency is the root deficiency, which manifests as insufficient lung qi and kidney failure to receive qi. After catching a cold, the external evil induces the phlegm and blood stasis inside, forming a superficial excess syndrome, with cough, chest tightness, and aggravated wheezing, which belongs to the syndrome of root deficiency and superficial excess.

[0103] TCM diagnosis: deficiency of both lung and kidney, diagnosed as stable stage of chronic obstructive pulmonary disease.

[0104] Intervention measures: Use the Chinese medicine decoction of Example 1. Take one dose per day, decoct in water and take warm twice a day in the morning and evening, for a total of 14 doses.

[0105] Disease progression and outcome: Second visit: The patient said that after taking the above prescription, chest tightness was significantly improved, with occasional cough and wheezing, chills and fatigue, and good appetite, good sleep, and normal bowel movements. Chinese medicine tongue and pulse: pale red tongue, white fur, and fine pulse. Continue to take the above prescription once a day, for a total of 14 doses. Follow-up after half a year, shortness of breath after activity is not obvious, no fever, physical strength has increased, and mental state is good.

[0106] Case 2: Patient 2, male, 63 years old, complained of “recurrent cough and asthma for more than 5 years”.

[0107] Current medical history: The condition is stable, but the patient currently has cough, chest tightness and shortness of breath after activity, little sputum, white sputum with a hint of yellow, slight wheezing, bowel movements twice a day, no fear of chills or fever, dark tongue with greasy white coating and cracks in the middle, slightly tortuous sublingual veins, and a thin pulse.

[0108] Past history, personal history, family history, etc.: Past history of COPD for 10 years, denial of coronary heart disease, history of diabetes, denial of infectious diseases such as hepatitis; denial of family history of genetic diseases.

[0109] Auxiliary examination: Pulmonary function test: October 25, 2023: VCmax (2.86, 74%); FVCex (2.86, 77%); FEV1 (1.45, 51%); FEV1 / VCmax (51, 64%); FEV1 / FVCex (51, 64%); Severe mixed pulmonary ventilation dysfunction.

[0110] TCM diagnosis: deficiency of both lung and kidney, blood stasis syndrome, diagnosed as stable stage of chronic obstructive pulmonary disease.

[0111] Intervention measures: Use the Chinese medicine decoction of Example 3. One dose per day, decoct in water and take warm twice a day in the morning and evening, for a total of 14 doses.

[0112] Disease progression and outcome: Second diagnosis: Slightly short of breath, aggravated after activity, easily relapsed when exposed to cold, slightly cold hands and feet, red tongue with yellow greasy coating, cracks in the middle, slightly congested veins under the tongue, thin pulse. Follow-up after half a year, the patient had slight chest tightness, and no other discomfort was obvious.

[0113] Clinical trials of the present invention have shown that the Chinese medicine composition of the present invention has significant therapeutic effects on the symptoms of stable chronic obstructive pulmonary disease, including improving symptoms such as cough, sputum, chest tightness, shortening the patient's cough relief time and cure time, improving the patient's quality of life and lung function indicators, and no results that were normal before treatment and abnormal after treatment were found, and the drug safety is good.

[0114] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions described in the above embodiments may still be modified, or some or all of the technical features therein may be replaced by equivalents. These modifications or replacements, or the technical features in the above embodiments may be combined in the manner described in the embodiments if they do not conflict with each other, and these modifications, replacements or combinations do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for improving the symptoms of chronic obstructive pulmonary disease in the stable phase, characterized in that: The traditional Chinese medicine composition is prepared from a medicinal material composition comprising the following components in parts by mass: 13-17 parts of roasted astragalus, 13.5-16.5 parts of codonopsis pilosula, 9-11 parts of cooked rehmannia, 13.5-16.5 parts of cornus officinalis, 9-11 parts of mulberry bark, 9-11 parts of platycodon, 5-7 parts of roasted liquorice, 5-7 parts of earthworm, 27-33 parts of rhizoma dioscoreae, 16-18 parts of elaeagnus root, 7-9 parts of calcined purple quartz and 13.5-16.5 parts of ophiopogon.

2. The Chinese medicine composition according to claim 1, characterized in that: The medicinal material composition comprises: 15 parts of roasted Astragalus, 15 parts of Codonopsis, 10 parts of Rehmannia, 15 parts of Cornus, 10 parts of Morus alba, 10 parts of Platycodon, 6 parts of roasted Licorice, 6 parts of Pheretima, 30 parts of Rhizoma Dioscoreae, 17 parts of Elaeagnus Root, 8 parts of Amethyst and 15 parts of Radix Ophiopogonis; or, The medicinal material composition comprises: 16 parts of roasted Astragalus, 16 parts of Codonopsis, 9 parts of Rehmannia, 14 parts of Cornus, 10 parts of Morus alba, 10 parts of Platycodon, 7 parts of roasted Licorice, 5 parts of Pheretima, 32 parts of Rhizoma Dioscoreae, 18 parts of Elaeagnus Root, 9 parts of Amethyst and 16.5 parts of Radix Ophiopogonis; or, The medicinal material composition comprises: 17 parts of roasted Astragalus, 16.5 parts of Codonopsis, 11 parts of Rehmannia, 16.5 parts of Cornus, 9 parts of Morus alba, 9 parts of Platycodon, 5 parts of roasted Licorice, 7 parts of Pheretima, 33 parts of Rhizoma Dioscoreae, 16 parts of Elaeagnus Root, 8 parts of Amethyst and 14 parts of Radix Ophiopogonis; or, The medicinal material composition comprises: 13 parts of roasted astragalus, 13.5 parts of codonopsis pilosula, 11 parts of cooked rehmannia, 13.5 parts of cornus officinalis, 11 parts of mulberry bark, 11 parts of platycodon, 7 parts of roasted liquorice, 5 parts of earthworm, 27 parts of rhizoma dioscoreae, 16 parts of elaeagnus root, 7 parts of calcined purple quartz and 13.5 parts of ophiopogon.

3. The Chinese medicine composition according to claim 1, characterized in that: The medicinal material composition also includes 12-15 portions of Houttuynia cordata.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is in the form of decoction, capsule, tablet, pill, oral liquid, paste or powder.

5. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is a decoction, and its preparation method is as follows: weigh the medicinal materials according to the components of the medicinal material composition, wash the floating soil with clean water, dry and sterilize with microwave; soak the Rhizoma Dioscoreae in 40-50℃ warm water for 10-15min to soften the fiber, and then cut the roasted Astragalus, Codonopsis and Rhizoma Dioscoreae into 3-5mm thick slices; bake the earthworm until the water content is ≤8%, and then soak it in 70-75% ethanol for 20-30min after crushing, and filter out the ethanol; first put the calcined purple quartz into water and boil it for 30-50min, then put all the other medicinal materials into water and soak it for 30-40min, add water to exceed the surface of the medicine by 2-3cm, boil it for the first time for 15-20min, pour out 1 / 2 of the medicinal liquid, then add warm water for the second boiling for 25-35min, pour out all the medicinal liquid, combine the two medicinal liquids and mix them evenly to obtain the decoction.

6. The Chinese medicine composition according to claim 1, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: Step 1: weigh the medicinal materials according to the components of the medicinal material composition, wash the floating soil with water, dry it, and then sterilize it with microwave; Step 2: Soak the Rhizoma Dioscoreae in 40-50℃ warm water for 10-15min to soften the fibers, then cut the roasted Astragalus, Codonopsis and Rhizoma Dioscoreae into 3-5mm thick slices; crush the calcined purple quartz into 80 mesh fine powder; dry the earthworm until the moisture content is ≤8%, and soak it in 70-75% ethanol for 20-30min to inactivate enzymes and reduce the fishy smell, and then filter to remove the ethanol; Step 3: Mix all the medicinal material compositions with 8 times the mass of water, add 5wt% rice vinegar or citric acid to the water, pre-soak for 0.5-1h, heat to 90-95°C for 30-40min, stir simultaneously, cool to 60-70°C, add 0.1wt% cellulase, and perform enzymolysis for 40-70min. During the extraction process, connect a condensation reflux device to the top of the extraction tank to collect the volatile components of Morus alba and Platycodon grandiflorum, and finally add the collected condensate back to the medicinal solution; Step 4: Concentrate the extract under the conditions of vacuum degree -0.08MPa and temperature of 55-65°C to obtain a concentrated paste with a relative density of 1.25-1.30 at 70°C; Step 5: Add auxiliary materials to the concentrated paste and process it according to the preparation process of capsules, tablets, pills, pastes or powders. The finished product is sterilized by γ-ray irradiation at a dose of 8-10 kGy and packaged.

7. The Chinese medicine composition according to claim 6, characterized in that: The Chinese medicine composition is a powder, and the method of step 5 is: mixing the concentrated paste with dextrin and microcrystalline cellulose in a mass ratio of 1:0.9:0.3, and preparing the particles with a size of 80-100 mesh and a moisture content of ≤5% by a centrifugal spray drying tower; or, The Chinese medicine composition is a capsule, and the method of step 5 is: mixing the concentrated paste with dextrin and microcrystalline cellulose in a mass ratio of 1:0.9:0.3, directly preparing 80-100 mesh granules through a centrifugal spray drying tower, and then filling the capsules; or, The Chinese medicine composition is a tablet. The method of step 5 is: evenly spread the concentrated paste on a stainless steel tray, place it in a vacuum drying oven and dry it to a moisture content of ≤5% to obtain a dry paste, process the dry paste with a jet mill to a particle size of 80-100 mesh, sieve it and mix it evenly with auxiliary materials, spray 5% HPMC solution to granulate, control the moisture content of the wet granules to 8-12%, dry the wet granules in a fluidized bed dryer to a moisture content of ≤3% to obtain dry granules, sieve the dry granules to size them, add magnesium stearate for secondary mixing, press them on a machine, and coat the qualified compressed tablets with an HPMC-based coating liquid to obtain tablets.

8. The Chinese medicine composition according to claim 1, characterized in that: The preparation method of the calcined purple quartz is: smash the raw ore into small pieces, and calcine the purple quartz in vacuum at a calcination temperature of 750-800° C. for 2-3 hours.