A traditional Chinese medicine composition for improving the symptoms of stable chronic obstructive pulmonary disease

Abstract

The present invention relates to a traditional Chinese medicine composition for improving the symptoms in the stable stage of chronic obstructive pulmonary disease. By mass, the traditional Chinese medicine composition is prepared from a medicinal material composition comprising the following components: 13-17 parts of stir-fried Astragalus membranaceus, 13.5-16.5 parts of Codonopsis pilosula, 9-11 parts of Rehmannia glutinosa, 13.5-16.5 parts of Cornus officinalis, 9-11 parts of Morus alba root bark, 9-11 parts of Platycodon grandiflorum, 5-7 parts of stir-fried Glycyrrhiza uralensis, 5-7 parts of Pheretima aspergillum, 27-33 parts of Dioscorea nipponica, 16-18 parts of Elaeagnus root, 7-9 parts of calcined fluorite, and 13.5-16.5 parts of Ophiopogon japonicus. Clinical trial research shows that the traditional Chinese medicine composition of the present invention has obvious improvement in the symptoms in the stable stage of chronic obstructive pulmonary disease, including improving symptoms such as cough, expectoration, and chest tightness, shortening the cough remission time and cure time of patients, improving the quality of life and lung function indexes of patients, etc., all having significant curative effects, and no results that are normal before treatment but abnormal after treatment are found, and the drug safety is good.

Description

Technical Field

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

[0002] Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease, which is mainly characterized by airway inflammation and is caused by multiple factors such as smoking, air pollution, and genetics. Western medicine mainly relieves symptoms through anti-inflammatory and bronchodilation to treat COPD, but its potential risks are the increasing bacterial resistance rate year by year, many adverse reactions, poor patient compliance, some patients cannot tolerate mechanical ventilation treatment, the 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 guidelines, COPD is divided into a stable stage and an acute exacerbation stage according to the stable condition and severity of the disease. In clinical practice, the "stable stage" is a key stage of this disease, showing relatively stable clinical characteristics and playing a crucial role in the long-term management of the disease. This stage is also regarded as the core part of the disease process. In traditional Chinese medicine clinical practice, the stable stage of COPD is mainly characterized by deficiency of the root and excess of the tip, and a relatively balanced state of deficiency and excess. When differentiating syndromes, it is necessary to carefully distinguish the subtle differences and their interrelationships between deficiency and excess, and at the same time pay attention to the accurate identification of single syndromes and compound syndromes. Since the syndrome differentiation and treatment and the compatibility of prescriptions in the stable stage both face challenges, more accurate guidance and scientific verification are needed to ensure the effectiveness and safety of treatment.

[0004] The stable stage of COPD includes two main types: deficiency of both the lung and kidney, and phlegm stasis obstructing the lung. At present, Chinese Patent CN119345319A discloses a traditional Chinese medicine compound for treating the stable stage of chronic obstructive pulmonary disease and its application. The traditional Chinese medicine composition contains epimedium, curculigo rhizome, astragalus membranaceus, salvia miltiorrhiza, earthworm, dioscorea nipponica, ophiopogon japonicus, scutellaria baicalensis, southern adenophora root, dried ginger, mulberry bark, pinellia ternata, coptis chinensis, and ginkgo biloba. This prescription mainly focuses on warming yang and supplementing qi (epimedium, curculigo rhizome, astragalus membranaceus), and also has the functions of clearing heat and resolving phlegm (scutellaria baicalensis, mulberry bark) and promoting blood circulation and dredging collaterals (salvia miltiorrhiza, earthworm, dioscorea nipponica). It has the risk of injuring yin due to warmth and dryness: the proportion of yang-warming drugs such as epimedium, curculigo rhizome, and dried ginger is large, and long-term use may consume lung yin, especially for patients with yin-deficiency type COPD (such as those with red tongue and little coating, and dry cough without phlegm), which may aggravate the symptoms; although ophiopogon japonicus and southern adenophora root can nourish yin, their dosages are relatively weak compared with the yang-warming drugs and are difficult to completely balance. In addition, pinellia ternata, dried ginger, coptis chinensis, etc. may stimulate the gastrointestinal tract and easily cause abdominal distension in those with weak spleen and stomach. The dosage span of each medicinal material in this prescription is large, and the rigor of the compatibility is in doubt.

[0005] Chinese Patent CN119139398A discloses a traditional Chinese medicine compound for treating chronic obstructive pulmonary disease (COPD) in the stable stage of the syndrome of deficiency of both the lung and kidney, and its preparation method and application. The raw materials of the traditional Chinese medicine compound include: 18 - 22 g of Codonopsis pilosula, 9 - 12 g of Morinda officinalis, 12 - 16 g of Astragalus membranaceus (prepared with honey), 7 - 11 g of Atractylodes macrocephala, 9 - 11 g of Rehmannia glutinosa, 9 - 12 g of Cuscuta chinensis, 3 - 8 g of Cinnamomum cassia, 10 - 15 g of Salvia miltiorrhiza, and 2 - 6 g of Ephedra sinica (prepared with honey). This prescription focuses on tonifying the lung and kidney (Codonopsis pilosula, Morinda officinalis, Rehmannia glutinosa), supplementing qi and promoting blood circulation (Astragalus membranaceus (prepared with honey), Salvia miltiorrhiza), and is assisted by drugs with pungent - warm properties for dispersing the lung - qi (Ephedra sinica (prepared with honey), Cinnamomum cassia). Among them, the side effects of pungent - warm drugs are prominent. Ephedra sinica (prepared with honey) contains ephedrine, which may induce palpitation and elevated blood pressure, posing a higher risk to COPD patients with concomitant cardiovascular diseases; Cinnamomum cassia is pungent - warm and dispersing, which may exacerbate the tidal fever and night sweats in patients with yin - deficiency and internal heat. There is only one herb, Rehmannia glutinosa, for nourishing yin and moistening the lung in the prescription, and its dosage is relatively low, resulting in limited efficacy for COPD patients with deficiency of both lung and kidney yin (such as wheezing accompanied by dry throat and scanty, sticky phlegm).

[0006] Chinese Patent CN118217352A discloses a traditional Chinese medicine composition for treating stable - stage chronic obstructive pulmonary disease, which contains 15 - 45 parts of Astragalus membranaceus, 2 - 18 parts of Atractylodes macrocephala, 2 - 18 parts of Saposhnikovia divaricata, 5 - 25 parts of Rehmannia glutinosa, 10 - 30 parts of Dioscorea opposita, 5 - 25 parts of Cornus officinalis, 2 - 18 parts of Alisma orientale (prepared with salt), 2 - 18 parts of Paeonia suffruticosa, 5 - 25 parts of Poria cocos, 5 - 25 parts of Panax ginseng, 10 - 30 parts of Epimedium brevicornu (prepared with honey), 2 - 18 parts of Schisandra chinensis, 1 - 10 parts of Gecko, 15 - 45 parts of Juglans regia, 2 - 18 parts of Armeniaca vulgaris, 2 - 18 parts of Platycodon grandiflorum, 5 - 25 parts of Fritillaria thunbergii, and 100 - 150 parts of honey. This formula comprehensively supplements qi (Astragalus membranaceus, Panax ginseng), nourishes yin (Rehmannia glutinosa, Cornus officinalis), arrests wheezing by taking in qi (Gecko, Juglans regia), and takes into account resolving phlegm and relieving cough (Platycodon grandiflorum, Fritillaria thunbergii). However, the herbs are numerous and miscellaneous, the relationship between the monarch, minister, assistant, and envoy herbs is blurred, the treatment direction is not clear, which may reduce the pertinence to the main symptoms. Gecko is an endangered species and is extremely scarce and difficult to obtain. Honey is not suitable for diabetic COPD patients. Similarly, the dosage range of each herb in this prescription is large, and the rigor of the compatibility remains in doubt.

[0007] In view of the deficiencies of the prior art, based on the overall treatment concept of harmony, balance, and coordination, the present invention proposes a traditional Chinese medicine composition for improving the symptoms of stable - stage chronic obstructive pulmonary disease, which combines reducing pathogenic factors and strengthening healthy qi, regulating qi and blood, harmonizing yin and yang, coordinating the five flavors, and treating the zang - fu organs simultaneously. Summary of the Invention

[0008] (I) Technical Problems to be Solved

[0009] 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 - stage chronic obstructive pulmonary disease, which solves the technical problems existing in the prior - art traditional Chinese medicine compositions, such as warm - dryness damaging yin, using more pungent - warm herbs in the formula, numerous and miscellaneous herbs, and insufficient pertinence to the main symptoms.

[0010] (2) Technical Solution

[0011] In a first aspect, the present invention provides a traditional Chinese medicine composition for improving the symptoms in the stable stage of chronic obstructive pulmonary disease. Calculated by mass parts, it is made from a medicinal material composition comprising the following components: 13 - 17 parts of stir-fried astragalus membranaceus, 13.5 - 16.5 parts of codonopsis pilosula, 9 - 11 parts of rehmannia glutinosa, 13.5 - 16.5 parts of cornel, 9 - 11 parts of mulberry bark, 9 - 11 parts of platycodon grandiflorum, 5 - 7 parts of stir-fried licorice root, 5 - 7 parts of pheretima aspergillum, 27 - 33 parts of dioscorea nipponica, 16 - 18 parts of elaeagnus root, 7 - 9 parts of calcined fluorite, and 13.5 - 16.5 parts of ophiopogon japonicus.

[0012] According to a preferred embodiment of the present invention, the medicinal material composition comprises: 15 parts of stir-fried astragalus membranaceus, 15 parts of codonopsis pilosula, 10 parts of rehmannia glutinosa, 15 parts of cornel, 10 parts of mulberry bark, 10 parts of platycodon grandiflorum, 6 parts of stir-fried licorice root, 6 parts of pheretima aspergillum, 30 parts of dioscorea nipponica, 17 parts of elaeagnus root, 8 parts of calcined fluorite, and 15 parts of ophiopogon japonicus; or,

[0013] the medicinal material composition comprises: 15 parts of stir-fried astragalus membranaceus, 16 parts of codonopsis pilosula, 9 parts of rehmannia glutinosa, 14 parts of cornel, 10 parts of mulberry bark, 10 parts of platycodon grandiflorum, 7 parts of stir-fried licorice root, 5 parts of pheretima aspergillum, 32 parts of dioscorea nipponica, 18 parts of elaeagnus root, 9 parts of calcined fluorite, and 16.5 parts of ophiopogon japonicus; or,

[0014] the medicinal material composition comprises: 17 parts of stir-fried astragalus membranaceus, 16.5 parts of codonopsis pilosula, 11 parts of rehmannia glutinosa, 16.5 parts of cornel, 9 parts of mulberry bark, 9 parts of platycodon grandiflorum, 5 parts of stir-fried licorice root, 7 parts of pheretima aspergillum, 33 parts of dioscorea nipponica, 16 parts of elaeagnus root, 8 parts of calcined fluorite, and 14 parts of ophiopogon japonicus; or,

[0015] the medicinal material composition comprises: 13 parts of stir-fried astragalus membranaceus, 13.5 parts of codonopsis pilosula, 11 parts of rehmannia glutinosa, 13.5 parts of cornel, 11 parts of mulberry bark, 11 parts of platycodon grandiflorum, 7 parts of stir-fried licorice root, 5 parts of pheretima aspergillum, 27 parts of dioscorea nipponica, 16 parts of elaeagnus root, 7 parts of calcined fluorite, and 13.5 parts of ophiopogon japonicus.

[0016] According to a preferred embodiment of the present invention, the medicinal material composition further includes 12 - 15 parts of houttuynia cordata. When the heat syndrome is obvious, 12 - 15 parts of houttuynia cordata are added to enhance the heat-clearing power of the traditional Chinese medicine composition.

[0017] According to a preferred embodiment of the present invention, the traditional Chinese medicine composition is in the form of decoction, capsule, tablet, pill, oral liquid, ointment or powder.

[0018] According to a preferred embodiment of the present invention, the traditional 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 clear water, dry them, and then sterilize them by microwave. Dioscorea nipponica Makino is soaked in warm water at 40-50 °C for 10-15 minutes to soften the fibers, and then roasted Astragalus membranaceus, Codonopsis pilosula, and Dioscorea nipponica Makino are cut into slices with a thickness of 3-5 mm. Pheretima is baked until the water content is ≤ 8%, crushed, and then soaked in 70-75% ethanol for 20-30 minutes, and the ethanol is filtered off. First, calcined fluorite is put into water and decocted for 30-50 minutes, and then all the remaining medicinal materials are put into water and soaked for 30-40 minutes. Add water to exceed the drug surface by 2-3 cm, decoct for the first time for 15-20 minutes, pour out 1 / 2 of the medicinal liquid, add warm water for the second decoction for 25-35 minutes, pour out all the medicinal liquid, and mix the two medicinal liquids evenly to obtain the decoction.

[0019] According to a preferred embodiment of the present invention, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0020] Step 1: Weigh the medicinal materials according to the components of the medicinal material composition, rinse the floating soil with clear water, dry them, and then sterilize them by microwave;

[0021] Step 2: Dioscorea nipponica Makino is soaked in warm water at 40-50 °C for 10-15 minutes to soften the fibers, and then roasted Astragalus membranaceus, Codonopsis pilosula, and Dioscorea nipponica Makino are cut into slices with a thickness of 3-5 mm; Calcined fluorite is crushed into fine powder of 80 meshes; Pheretima is baked until the water content is ≤ 8%, crushed, and then soaked in 70-75% ethanol for 20-30 minutes to inactivate enzymes and reduce the fishy smell, and then the ethanol is filtered off;

[0022] Step 3: Mix all the medicinal material compositions with 8 times the mass of water, add 5 wt% of rice vinegar or citric acid (to increase the dissolution rate of Ca in calcined fluorite) to the water, pre-soak for 0.5-1 hour, then heat up to 90-95 °C and keep warm for 30-40 minutes, stir synchronously, cool down to 60-70 °C, add 0.1% cellulase (w / w), and enzymolyze for 40-70 minutes. During the extraction process, a condensation reflux device is connected to the top of the extraction tank to collect the volatile components of Morus alba L. root bark and Platycodon grandiflorum A. DC. (such as mulberrone A and platycodin D), and the collected condensate is finally added back to the medicinal liquid; 2+ Step 4: Under the conditions of a vacuum degree of -0.08 MPa and a temperature of 55-65 °C, concentrate the extract to obtain a concentrated paste with a relative density of 1.25-1.30 at 70 °C;

[0023] Step 5: Add excipients to the concentrated paste, and process according to the preparation procedures of capsules, tablets, pills, ointments or powders. The finished product is sterilized by γ-ray irradiation with a dose of 8-10 kGy and then packaged.

[0024] Step 5: Add excipients to the concentrated paste, and process according to the preparation procedures of capsules, tablets, pills, ointments or powders. The finished product is sterilized by γ-ray irradiation with a dose of 8-10 kGy and then packaged.

[0025] According to a preferred embodiment of the present invention, if the traditional Chinese medicine composition is a powder, the method of step 5 is as follows: mixing the concentrated paste with dextrin and microcrystalline cellulose according to a mass ratio of 1:0.9:0.3, and directly making particles with 80-100 meshes and water content ≤ 5% through a centrifugal spray drying tower (inlet air temperature 160 °C, outlet air temperature 85 °C).

[0026] Preferably, if the traditional Chinese medicine composition is a capsule, the method of step 5 is as follows: mixing the concentrated paste with dextrin and microcrystalline cellulose according to a mass ratio of 1:0.9:0.3, directly making 80-100 mesh particles through a centrifugal spray drying tower, and then filling capsules.

[0027] Preferably, if the traditional Chinese medicine composition is a tablet, the method of step 5 is as follows: evenly spreading the concentrated paste on a stainless-steel tray, placing it in a vacuum drying oven to dry until the water content ≤ 5% to obtain a dry paste, processing the dry paste with a jet mill to a particle size of 80-100 meshes, sieving and then mixing evenly with auxiliary materials, spraying a wetting agent (such as 5% HPMC solution) to granulate, controlling the water content of the wet particles at 8-12%, drying the wet particles in a fluidized bed dryer until the water content ≤ 3% to obtain dry particles, sizing the dry particles through a vibrating sieve, adding magnesium stearate for secondary mixing, tableting on a machine, and coating the qualified tablets with an HPMC-based coating solution to obtain tablets.

[0028] According to a preferred embodiment of the present invention, the processing method of the calcined purple quartz is as follows: smashing the original ore into small pieces, calcining the purple quartz in a vacuum furnace (pressure ≤ 0.01 MPa), with a calcining temperature of 750-800 °C and a calcining time of 2-3 h to reduce the volatilization and pollution of fluoride.

[0029] The processing methods of roasted astragalus root, prepared rehmannia root, and roasted licorice root can be referred to the "Chinese Pharmacopoeia 2020 Edition". The processed medicinal materials can be used as the raw materials of the traditional Chinese medicine composition in this case, or the processing can also be carried out with reference to the following steps.

[0030] Processing method of roasted astragalus root: Take astragalus root slices, place 25% by weight of honey in a pot, heat it over low heat and stir continuously. When the honey turns light yellow, slightly viscous and has no obvious bubbles, pour in the astragalus root slices and mix evenly to make the honey evenly adhere; then heat and stir-fry over low heat, continuously stir-fry until the surface of the astragalus root slices turns dark yellow and is not sticky to the hand, and then take it out of the pot; place the stir-fried astragalus root in a ventilated and dry place to dry, or dry it at 40-60 °C, and sieve out debris and impurities with a sieve after drying to obtain roasted astragalus root.

[0031] Processing method of prepared rehmannia root: Take raw rehmannia root, place it in 30-60% by weight of yellow rice wine and mix evenly to make the yellow rice wine fully infiltrate the raw rehmannia root; then put the infiltrated raw rehmannia root and yellow rice wine into a suitable container, seal it, and heat it in a water bath until the wine is absorbed (the stewing time is relatively long, about 36-48 hours).

[0032] Take it out when the interior and exterior of the rehmannia glutinosa are both black, the texture is soft, and it tastes sweet; after taking it out, place it in a ventilated place to dry. When there is no obvious moist feeling on the surface, cut it into thick slices or pieces, and dry it to obtain prepared rehmannia glutinosa.

[0033] Processing method of roasted licorice root: Take roasted licorice root slices, place them in honey with a weight fraction of 25%, stir evenly to fully soak the roasted licorice root slices in honey, let it stand for moistening 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 gentle fire, keep stir-frying, stir-fry until the surface shows an old yellow color, is not sticky to the touch and has a fragrance escaping, immediately take it out of the pot, spread it out and place it in a ventilated and dry place to cool, sieve out the debris, and then obtain roasted licorice root.

[0034] (III) Beneficial effects

[0035] The traditional Chinese medicine formula of the present invention is based on the overall treatment concept of combining purgation and supplementation, harmony of qi and blood, balance of yin and yang, coordination of five flavors, simultaneous treatment of zang-fu organs and regulation of qi movement, avoiding problems such as perverse properties of traditional prescriptions, single efficacy of formula composition, damage to yin due to warm and dry nature, miscellaneous taste of herbs and lack of pertinence. The traditional Chinese medicine composition of the present invention conforms to the pathogenesis and characteristics of COPD, pays more attention to the overall situation and harmony, so as to achieve the dynamic balance of human yin and yang, qi and blood, and zang-fu organ functions, and finally realize the healthy state of "yin and yang in balance". Through the synergistic effect of multiple herbs, the present invention can not only improve the symptoms of COPD patients, but also regulate the body function and restore the healthy state, which is a profound embodiment of the concept of overall harmony and dynamic balance in traditional Chinese medicine.

[0036] The traditional Chinese medicine composition of the present invention realizes the balance between supplementing qi and nourishing yin and activating blood circulation and dredging collaterals. The combination of roasted astragalus membranaceus and codonopsis pilosula realizes qi supplementation, strengthens the qi of the lung and spleen, and increases the strength of qi supplementation; the three herbs of prepared rehmannia glutinosa, cornelian cherry fruit and ophiopogon japonicus work together to nourish the kidney yin and moisten the lung dryness, making up for the deficiency of damaging yin due to warm and dry nature in the existing formula; the combination of pheretima and dioscorea nipponica can improve the pulmonary microcirculation and specifically solve the core pathogenesis of COPD; cornelian cherry fruit strengthens the kidney and ophiopogon japonicus moistens the lung, which fits the pathological characteristics of "prolonged illness involving the kidney and deficiency of both the lung and kidney" in COPD; mulberry bark clears the lung and resolves phlegm, platycodon grandiflorum disperses the lung and expels phlegm, and dioscorea nipponica dredges collaterals and relieves asthma, aiming at the pathogenesis of "intermingled phlegm and stasis, phlegm and stasis blocking collaterals".

[0037] The traditional Chinese medicine composition of the present invention does not contain rare and protected animal-derived medicinal materials and honey (contraindicated for diabetes), the sources of medicinal materials are rich, and the cost is controllable. Calcined fluorite combines high-temperature calcination and vinegar quenching, with low fluoride toxicity; elaeagnus root contains quercetin and has an anti-inflammatory effect, which may enhance the anti-asthma effect. A relatively high dose of dioscorea nipponica exerts anti-inflammatory and immune regulatory effects and also exerts a collateral dredging effect. When the heat syndrome is obvious, houttuynia cordata and mulberry bark are combined to clear the lung heat. The traditional Chinese medicine composition of the present invention is especially suitable for the stable stage of COPD with deficiency of both qi and yin of the lung and kidney and intermingled phlegm and stasis (symptoms include shortness of breath, fatigue, wheezing on movement, dry cough with little phlegm, and soreness and weakness of the waist and knees).

[0038] In summary, by balancing tonifying and resolving phlegm, activating blood circulation, and applying both tonification and elimination, the present invention enhances the effectiveness and safety of the medicine. Detailed implementation mode

[0039] A traditional Chinese medicine composition for improving the symptoms of the stable stage of chronic obstructive pulmonary disease according to the present invention is prepared from a medicinal material composition comprising the following components: 13 - 17 parts of stir-fried astragalus membranaceus, 13.5 - 16.5 parts of codonopsis pilosula, 9 - 11 parts of rehmannia glutinosa, 13.5 - 16.5 parts of cornel officinalis, 9 - 11 parts of mulberry bark, 9 - 11 parts of platycodon grandiflorum, 5 - 7 parts of stir-fried licorice root, 5 - 7 parts of pheretima aspergillum, 27 - 33 parts of dioscorea nipponica, 16 - 18 parts of elaeagnus root, 7 - 9 parts of calcined fluorite, and 13.5 - 16.5 parts of ophiopogon japonicus. Among them, the sovereign drugs are stir-fried astragalus membranaceus and codonopsis pilosula; the ministerial drugs are rehmannia glutinosa, cornel officinalis, fluorite, and ophiopogon japonicus; the adjuvant drugs are pheretima aspergillum, dioscorea nipponica, elaeagnus root, mulberry bark, and platycodon grandiflorum; the guiding drug is stir-fried licorice root.

[0040] Sovereign drugs: Stir-fried astragalus membranaceus is sweet and warm in nature, entering the lung and spleen meridians, greatly tonifying the qi of the lung and spleen, having the effects of protecting the muscle surface, resisting exogenous pathogens, lifting yang qi, and promoting the circulation of qi and blood, and is an important drug for tonifying the lung and spleen. Codonopsis pilosula is sweet in taste and neutral in nature, being good at supplementing the qi of the spleen and stomach, and can also benefit the lung qi, nourish blood, and promote the production of body fluid. Combined with stir-fried astragalus membranaceus, they jointly play the role of strengthening the spleen and nourishing the lung, cultivating the acquired foundation, enabling the qi and blood to be generated from the source, thereby nourishing the lung qi and becoming the cornerstone of strengthening the healthy qi and consolidating the root. After stir-frying, the qi-tonifying effect of astragalus membranaceus is enhanced. When used in combination with codonopsis pilosula, it can significantly improve the effect of strengthening the spleen and nourishing the lung.

[0041] Ministerial drugs: Rehmannia glutinosa is sweet and warm in nature, having the effects of nourishing yin and blood, replenishing essence and marrow, mainly acting on nourishing the kidney yin and enriching the essence in the kidney, and is an important drug for tonifying the kidney. Cornel officinalis is sour, astringent, and slightly warm in taste, with the function of tonifying the liver and kidney and consolidating essence qi. Fluorite enters the lung and kidney meridians, is sweet and warm in nature, can warm the kidney and assist yang, warm the lung and relieve asthma, promote the dissipation of phlegm and stasis by warming yang, prevent nourishing and greasy substances from obstructing pathogens, and seek yang in yin, enabling yang to be assisted by yin and generating infinitely, and more effectively play the role of warming the kidney and accepting qi. Ophiopogon japonicus is sweet and slightly cold in nature, belonging to the lung, heart, and stomach meridians, having the effects of nourishing yin and moistening the lung, promoting the production of body fluid in the stomach, being able to nourish the lung yin and avoid the overly warm and dry nature of the yang-tonifying drugs. All these drugs cooperate with each other to achieve the effect of tonifying both yin and yang and coordinating moistening and dryness in the whole formula, being neither hot and dry nor greasy.

[0042] Assistant herbs: Earthworm is salty and cold in nature, belonging to the lung meridian, with the effects of dredging meridians and collaterals, and relieving asthma, which helps to improve the stasis of qi and blood in the lungs and relieve bronchospasm and wheezing symptoms. Dioscorea nipponica is bitter and warm in nature, entering the lung meridian, capable of activating blood circulation to dredge collaterals, expelling wind and removing dampness, relieving cough and asthma. When used together with fluorite, it "regulates both the lung and the kidney", treating not only surface symptoms such as cough and asthma, but also fundamentally warming the kidney and consolidating the root. Elaeagnus root is neutral in nature, good at astringing the lung qi, relieving cough and asthma, expelling wind and removing dampness. Quercetin contained in Elaeagnus root inhibits the release of histamine and relieves bronchospasm, especially suitable for cases of persistent cough and weak lung qi. At the same time, Elaeagnus root has antibacterial effects, including inhibiting respiratory tract infection bacteria (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae) and Gram-positive representative bacteria (Bacillus subtilis). Morus alba root-bark is sweet and cold in nature, specifically entering the lung meridian, capable of purging the lung to relieve asthma, promoting diuresis and reducing edema, and helping to restore the normal function of the lungs. Platycodon grandiflorum is pungent and dispersing, bitter and cathartic, dispersing the lung qi, eliminating phlegm and relieving sore throat, and can also conduct drugs upward, guiding the drugs directly to the affected area, that is, the lung meridian. The combination of earthworm and Dioscorea nipponica dredges collaterals and relieves asthma, activates blood circulation and resists fibrosis. The combination of Morus alba root-bark and Platycodon grandiflorum disperses the lung qi and resolves phlegm, with the ascending and descending acting in concert. The combination of Elaeagnus root and Morus alba root-bark relieves cough and asthma, and has anti-inflammatory and antioxidant effects. In the formula, only Morus alba root-bark is insufficient in clearing lung heat. When the patient has yellow and thick phlegm and fever, Houttuynia cordata needs to be added to strengthen the heat-clearing effect.

[0043] Guiding herb: Prepared licorice is sweet and flat in nature, harmonizing all herbs, moderating the properties of other herbs, ensuring that the whole formula is tonifying without stagnation, attacking without damaging the healthy qi, and synergistically exerting the effects of tonifying the lung, strengthening the spleen and kidney, eliminating phlegm and removing stasis, relieving asthma and cough.

[0044] The traditional Chinese medicine composition of the present invention fully implements the principles of strengthening healthy qi and eliminating pathogenic factors, treating both the symptoms and the root causes, taking into account yin, yang, qi and blood, combining movement and stillness, and regulating the viscera together, with a mild medicinal property. This formula takes strengthening healthy qi as the leading factor, supplemented by eliminating pathogenic factors. Through the method of combining supplementation and purgation, it not only supplements the deficiency of the human body, but also expels external pathogenic factors, avoiding the phlegm stagnation that may be caused by simple supplementation, or the damage to healthy qi caused by only focusing on eliminating pathogenic factors, perfectly reflecting the treatment concept of "strengthening healthy qi and eliminating pathogenic factors" in traditional Chinese medicine. In terms of drug compatibility, the herbs for nourishing yin and blood and benefiting qi and warming yang cooperate with each other, aiming to harmonize yin, yang, qi and blood in the human body and restore the balance of qi, blood, yin and yang in the body. This formula starts from the three viscera of the lung, spleen and kidney, not only supplementing the qi of the lung and spleen, but also nourishing the kidney yin and warming the kidney yang, focusing on overall regulation and achieving the goal of treating the viscera together. Through the methods of combining movement and stillness, regulating cold and heat, taking into account the five flavors, and combining supplementation and purgation appropriately, the bias of the medicinal properties is prevented, ensuring the overall mildness of the formula, suitable for long-term taking for conditioning, so as to achieve the purpose of optimizing the health status.

[0045] The significant advantages of the traditional Chinese medicine composition of the present invention are as follows:

[0046] 1. Comprehensive treatment with multiple targets, treating both the symptoms and the root causes;

[0047] By carefully selecting a variety of medicinal materials for compatibility, it achieves the effects of tonifying the lungs, spleen, and kidneys, as well as treating multiple aspects such as resolving phlegm and removing stasis, relieving asthma and cough, and regulating the body's functions as a whole to improve disease symptoms.

[0048] 2. Strengthen the healthy qi and dispel pathogenic factors, combining supplementation and purgation;

[0049] Using roasted astragalus root and codonopsis pilosula as the sovereign herbs, whose main function is to greatly tonify the qi of the lungs and spleen; the ministerial herbs such as rehmannia glutinosa, cornel fruit, fluorite, and ophiopogon japonicus are used to nourish the lungs, spleen, and kidneys, further enhancing the healthy qi of the body. Among the assistant herbs, pheretima aspergillum and dioscorea nipponica activate blood circulation and dredge collaterals and relieve asthma, elaeagnus root astringes the lung qi and relieves cough, mulberry bark purges the lung and relieves asthma, and platycodon grandiflorum disperses the lung qi and eliminates phlegm, playing the role of dispelling pathogenic factors for the phenomenon of phlegm and stasis obstructing the lungs. Designed in this way, it not only strengthens the root but also eliminates surface symptoms, achieving the therapeutic effect of combining supplementation and purgation, and is especially suitable for cases with a long course of disease and a mixture of deficiency and excess.

[0050] 3. Tonify both yin and yang;

[0051] Among the ministerial herbs, rehmannia glutinosa and cornel fruit nourish yin, fluorite warms yang, and ophiopogon japonicus nourishes yin and moistens dryness. When these herbs are combined, on the basis of nourishing yin, they supplement the kidney yang, promoting the mutual generation and restriction of yin and yang in the kidney, achieving a state of yin-yang balance. This compatibility strategy embodies the concept of "those who are good at nourishing yin must seek yin from yang, so that yin can be promoted by yang and the source will never dry up", and at the same time avoids the problem of excessive warmth and dryness of simple yang-tonifying drugs, jointly achieving the effect of tonifying both yin and yang, making the whole formula tonifying without being dry and nourishing without being greasy.

[0052] 4. Regulate both qi and blood;

[0053] In view of the principle of "qi is the commander of blood, and blood is the mother of qi", this composition regulates the dynamic balance of qi and blood by tonifying qi and activating blood circulation, nourishing yin and regulating qi, etc. Roasted astragalus root, codonopsis pilosula, and fluorite tonify the qi of the lungs, spleen, and kidneys, and sufficient qi promotes blood circulation; dioscorea nipponica and pheretima aspergillum activate blood circulation and remove stasis; rehmannia glutinosa, ophiopogon japonicus, and cornel fruit nourish yin and enrich blood; platycodon grandiflorum and mulberry bark disperse and descend the lung qi, regulating qi movement to ensure the smooth flow of qi and blood.

[0054] 5. Combine movement and stillness;

[0055] Adopt the method of combining tonifying medicinal materials and blood-activating medicinal materials, which can not only statically maintain the normal state but also dynamically dredge and promote. With qi-tonifying as the main, supplemented by promoting blood circulation and removing stasis, it ensures that qi-tonifying will not lead to qi and blood stagnation, effectively improving the state of phlegm and stasis obstructing the lungs.

[0056] 6. Treat multiple viscera simultaneously;

[0057] Considering the characteristic that the disease gradually affects the spleen and kidneys from the lungs, this formula accurately uses medicine to achieve the simultaneous treatment of the lungs, spleen, and kidneys. Through the effects of different medicinal materials, it respectively tonifies the different needs of the lungs, spleen, and kidneys, realizing the application of the traditional Chinese medicine ideas of "holistic concept" and "simultaneous treatment".

[0058] 7. Harmonize the medicinal properties;

[0059] By using the method of combining cold and warm herbs, the whole formula is neither overly warm and dry nor overly cold, which conforms to the core concept of traditional Chinese medicine of "achieving balance". At the same time, licorice is used to harmonize all the herbs, ensuring the balance of medicinal properties, making the whole formula tonify without being overly drastic and purge without being overly fierce, with the medicinal power gentle and orderly. Finally, through the design of harmonious combination of the five flavors and orderly ascending and descending of the medicinal flavors, the harmonious state of "yin and yang are in equilibrium, and the spirit is well-governed" is achieved.

[0060] To better explain the present invention for easy understanding, the following will be described in detail in combination with specific examples and clinical trials. Unless otherwise specified, the medicinal materials and reagents involved in the embodiments of the present invention are commercially available products and can be obtained through commercial channels. The raw medicinal materials used in the basic formula all meet the requirements of the "Pharmacopoeia of the People's Republic of China (2020 Edition)" published by the China Medical Science and Technology Press.

[0061] Example 1

[0062] This example provides a traditional Chinese medicine decoction for improving the symptoms in the stable stage of chronic obstructive pulmonary disease. Its raw medicinal materials are: 15 g of roasted astragalus root, 15 g of codonopsis pilosula, 10 g of rehmannia glutinosa, 15 g of cornel, 10 g of mulberry bark, 10 g of platycodon grandiflorum, 6 g of roasted licorice root, 6 g of earthworm, 30 g of dioscorea nipponica, 17 g of elaeagnus root, 8 g of calcined fluorite, and 15 g of ophiopogon japonicus.

[0063] The preparation method of the traditional Chinese medicine decoction is as follows: Weigh the medicinal materials according to the components of the medicinal material composition, rinse the floating soil with clear water, dry them, and then sterilize them by microwave; Dioscorea nipponica is pre-soaked in warm water at 50 °C for 15 min to soften the fibers, and then the roasted astragalus root, codonopsis pilosula, and dioscorea nipponica are cut into slices 3 - 5 mm thick; The earthworm is dried until the water content is ≤ 8%, pulverized, and then soaked in 70 - 75% ethanol for 20 min, and the ethanol is filtered off; First, put the calcined fluorite into water and decoct for 30 min, then soak the remaining all medicinal materials in water for 30 min, add water 2 - 3 cm above the surface of the medicinal materials, decoct for 20 min for the first time, pour out 1 / 2 of the decoction, add warm water for the second decoction for 25 min, pour out all the decoction, and mix the two decoctions evenly to obtain the traditional Chinese medicine decoction, which is one dose and taken twice, morning and evening.

[0064] Example 2

[0065] This example provides a traditional Chinese medicine decoction for improving the symptoms in the stable stage of chronic obstructive pulmonary disease. Its raw medicinal materials are: 16 g of roasted astragalus root, 16 g of codonopsis pilosula, 9 g of rehmannia glutinosa, 14 g of cornel, 10 g of mulberry bark, 10 g of platycodon grandiflorum, 7 g of roasted licorice root, 5 g of earthworm, 32 g of dioscorea nipponica, 18 g of elaeagnus root, 9 g of calcined fluorite, and 16.5 g of ophiopogon japonicus. The preparation method of the decoction is the same as that in Example 1.

[0066] Example 3

[0067] This embodiment provides a traditional Chinese medicine decoction for improving the symptoms of stable chronic obstructive pulmonary disease. The raw materials of the medicinal herbs are: 17 g of roasted Astragalus membranaceus, 16.5 g of Codonopsis pilosula, 10 g of Rehmannia glutinosa, 16.5 g of Cornus officinalis, 10 g of Morus alba root bark, 10 g of Platycodon grandiflorum, 14 g of Houttuynia cordata, 5 g of roasted Glycyrrhiza uralensis, 6 g of Pheretima aspergillum, 30 g of Dioscorea nipponica, 17 g of Elaeagnus pungens root, 8 g of calcined fluorite, and 15 g of Ophiopogon japonicus. The preparation method of the decoction is the same as that of Example 1. The traditional Chinese medicine decoction of this embodiment is for patients with yellow and thick phlegm and obvious fever symptoms, to assist the heat-clearing power of Morus alba root bark and Platycodon grandiflorum and control the heat syndrome.

[0068] Example 4

[0069] This embodiment provides a traditional Chinese medicine powder for improving the symptoms of stable chronic obstructive pulmonary disease. The raw materials of the medicinal herbs are: 17 g of roasted Astragalus membranaceus, 16 g of Codonopsis pilosula, 11 g of Rehmannia glutinosa, 14 g of Cornus officinalis, 9 g of Morus alba root bark, 9 g of Platycodon grandiflorum, 6 g of roasted Glycyrrhiza uralensis, 7 g of Pheretima aspergillum, 33 g of Dioscorea nipponica, 16 g of Elaeagnus pungens root, 8 g of calcined fluorite, and 14 g of Ophiopogon japonicus.

[0070] The preparation method of the traditional Chinese medicine powder is as follows:

[0071] Step 1: Rinse the medicinal herbs with clear water to remove the floating soil, and after drying, perform microwave sterilization (2450 MHz, 3 minutes). The sterilization rate is high, replacing traditional multiple water washings and reducing the loss of water-soluble components.

[0072] Step 2: Soak Dioscorea nipponica in warm water at 50 °C for 10 min to soften the fibers, and then cut roasted Astragalus membranaceus, Codonopsis pilosula, and Dioscorea nipponica into slices 3 - 5 mm thick; crush calcined fluorite into fine powder of 80 mesh; dry Pheretima aspergillum until the water content ≤ 8%, crush it, and soak it in 70% ethanol for 20 min to inactivate enzymes and reduce the fishy smell, and then filter to remove the ethanol.

[0073] Step 3: Mix all the medicinal herb compositions with 8 times the mass of water, add 5 wt% of rice vinegar to the water, pre-soak for 0.5 h, then heat up to 90 °C and keep warm for 30 min, stir synchronously, cool down to 70 °C, add 0.1% cellulase (w / w), and enzymolyze for 60 min. During the extraction process, connect a condensation reflux device to the top of the extraction tank to collect the volatile components of Morus alba root bark and Platycodon grandiflorum, and finally add the collected condensate back to the medicinal liquid;

[0074] Step 4: Under the conditions of a vacuum degree of -0.08 MPa and a temperature of 60 °C, concentrate the extract to obtain a concentrated paste with a relative density of 1.30 at 70 °C;

[0075] Step 5: Mix the concentrated paste with dextrin and microcrystalline cellulose according to a mass ratio of 1:0.9:0.3, and make it into a granular powder of 80 mesh and water content ≤ 5% through a centrifugal spray drying tower (inlet air temperature 160 °C, outlet air temperature 85 °C), and divide it into two bags for packaging. Take one bag with warm boiled water each in the morning and evening.

[0076] Example 5

[0077] This example provides a traditional Chinese medicine powder for improving the symptoms of stable chronic obstructive pulmonary disease. Its raw materials are: 13 g of roasted Astragalus membranaceus, 13.5 g of Codonopsis pilosula, 11 g of Rehmannia glutinosa, 13.5 g of Cornus officinalis, 11 g of Mori Cortex, 11 g of Platycodon grandiflorum, 7 g of roasted Glycyrrhiza uralensis, 5 g of Pheretima aspergillum, 32 g of Dioscorea nipponica, 16 g of Elaeagnus root, 7 g of calcined Fluorite, and 13.5 g of Ophiopogon japonicus. The preparation method of the traditional Chinese medicine powder is the same as that in Example 4. The powder prepared according to the above prescription in this example is divided into two bags and taken one bag each morning and evening by mixing with warm water.

[0078] Control Example 1

[0079] In this control example, among the medicinal materials components in Example 1, "Fluorite" in the ministerial drug and "Elaeagnus root" in the adjuvant drug are removed, and the other components remain unchanged. After the ministerial drug in this control example lacks Fluorite, the overall prescription tends to be warm and dry; after the adjuvant drug lacks "Elaeagnus root", the curative effect on the syndrome of chronic cough due to lung deficiency becomes weaker. The traditional Chinese medicine decoction for relieving cough is obtained according to the method in Example 1.

[0080] Clinical Trials

[0081] I. General Information and Case Sources:

[0082] A total of 120 COPD patients in the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 1, 2021 to December 31, 2023 were collected as the research objects.

[0083] II. Diagnostic Criteria:

[0084] 1. Western Medicine Diagnostic Criteria:

[0085] Refer to the diagnostic criteria for COPD in the "Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (2021 Revised Edition)":

[0086] ① Having a history of smoking, exposure to risk factors such as biomass fuel exposure and air pollution, or host factors;

[0087] ② Having a history of repeated lower respiratory tract infections;

[0088] ③ The main symptoms are dyspnea, chronic cough, or expectoration;

[0089] ④ Pulmonary function measurement: FEV1 / FVC < 0.7 after using bronchodilators;

[0090] ⑤ After excluding other diseases, it can be diagnosed as COPD according to ①②③④.

[0091] 2. Traditional Chinese Medicine (TCM) diagnostic criteria: Refer to the diagnostic criteria for the syndrome of deficiency of both lung and kidney qi and yin in the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease in Traditional Chinese Medicine (2019 Edition) formulated by the Chinese Association of Chinese Medicine. The main symptoms are: ① Wheezing and shortness of breath, aggravated by movement; ② Spontaneous sweating or fatigue, aggravated by movement; ③ Prone to catching colds; ④ Weakness and soreness of the waist and knees; ⑤ Tinnitus, dizziness or vertigo. The secondary symptoms are: ① Dry cough or scanty sputum, expectoration not smooth; ② Night sweats; ③ Feverish sensation in the palms and soles of the feet; ④ Pale or red tongue, thin, scanty or peeled tongue coating, or deep, thready, weak or rapid and thready pulse.

[0092] Meeting 2 items out of ①, ②, ③ in the main symptoms, 1 item out of ④, ⑤, and 2 items in the secondary symptoms can be diagnosed as the syndrome of deficiency of both lung and kidney qi and yin.

[0093] III. Inclusion criteria:

[0094] 1. COPD patients who meet the Western medicine diagnostic criteria;

[0095] 2. Patients who meet the TCM disease differentiation belonging to the syndrome of deficiency of both lung and kidney qi and yin in COPD;

[0096] Meeting any one of the above two items;

[0097] 3. Aged 40 years ≤ age ≤ 85 years, gender is not limited;

[0098] 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 form.

[0099] IV. Exclusion criteria:

[0100] 1. Having other serious primary organic diseases, or having serious complications such as heart, liver, and kidney;

[0101] 2. Suffering from other diseases causing cough and wheezing, such as pulmonary tuberculosis, lung cancer, bronchiectasis, interstitial pulmonary fibrosis, etc.;

[0102] 3. Those with a history of allergy to the drugs used in this study;

[0103] 4. Pregnant and lactating women;

[0104] 5. Suffering from diseases such as mental abnormalities and cognitive disorders;

[0105] 6. Those who are currently participating in other trials or research.

[0106] V. Criteria for exclusion, dropout, and termination:

[0107] 1. Patients with poor compliance, who do not strictly follow the prescribed treatment and affect the evaluation of curative effect;

[0108] 2. Statistical or evaluation data are missing, incorrect or omitted, affecting the evaluation of curative effect;

[0109] 3. Other diseases that may affect treatment during the trial;

[0110] 4. Patients with severe adverse reactions during the trial;

[0111] 5. Those who develop other serious complications or whose condition worsens during the trial and may suffer dangerous events.

[0112] 6. Test methods:

[0113] 1. Grouping method:

[0114] 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.

[0115] 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.

[0116] (II) Treatment methods:

[0117] 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.

[0118] 2. Drug treatment:

[0119] 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.

[0120] 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.

[0121] 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.

[0122] For both groups, 14 days constituted one course of treatment, with a total of 1 course of treatment.

[0123] (III) Observation indicators:

[0124] 1. Safety indicators:

[0125] 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);

[0126] Observe possible adverse reactions, including local skin reactions and systemic reactions, such as whether general rashes, allergic reactions, and gastrointestinal reactions occur. Pay attention to analyzing the causes of adverse reactions, make accurate judgments in a timely manner, and truthfully record the treatment process and results;

[0127] 2. Efficacy indicators:

[0128] 1) Traditional Chinese medicine (TCM) syndrome scoring criteria: According to the TCM syndrome integral scale, cough, expectoration, and wheezing are regarded as the main symptoms, and different scores are assigned according to none, mild, moderate, and severe, from low to high as 0, 2, 4, and 6 points respectively. The four secondary symptoms of fever, thirst with preference for drinking, yellowish and scanty urine, and dry stools are rated as 0, 1, 2, and 3 points according to none, mild, moderate, and severe. The tongue and pulse are recorded as they are and are not counted as scoring items. The patients should be informed in detail about the TCM syndrome scoring situation, and the researchers should collect the changes in the patients' symptoms before and after treatment respectively.

[0129] 2) Western medicine efficacy evaluation criteria:

[0130] ① mMRC dyspnea score;

[0131] ② COPD Assessment Test (CAT);

[0132] ③ Pulmonary function indices: FEV1 / FVC, percentage of FEV1 predicted value.

[0133] ④ Six-minute walk distance (6MWD), mainly record the activity distance of the patient within six minutes, test the exercise endurance of the patient, record it once before and after treatment respectively, and the patient should be informed in detail about the test content and precautions before the test.

[0134] 3) Efficacy judgment criteria

[0135] Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" (2002 edition) to determine the efficacy judgment criteria, which are as follows:

[0136] ① Clinical control: Clinical symptoms and signs disappear or basically disappear, and the reduction rate of TCM syndrome integral ≥ 95%; Marked effect:

[0137] ② Marked effect: Clinical symptoms and signs are significantly improved, and the reduction rate of TCM syndrome integral ≥ 70% and < 95%;

[0138] ③ Effective: Clinical symptoms and signs are all improved, and the reduction rate of TCM syndrome integral ≥ 30% and < 70%;

[0139] ④ Ineffective: Clinical symptoms and signs are not significantly improved or even worsened, and the reduction rate of TCM syndrome integral < 30%;

[0140] The reduction rate of TCM syndrome scores in the above curative effect evaluation criteria is calculated using the Nimodipine method. The calculation formula is: Reduction rate of TCM syndrome scores = [(Total syndrome scores before treatment - Total syndrome scores after treatment) / Total syndrome scores before treatment] × 100%.

[0141] VII. Statistical analysis:

[0142] The SPSS 26.0 software was used to input and analyze the data. For measurement data, the mean ± standard deviation was used for data description. For data that conformed to normal distribution and homogeneity of variance, paired sample t-tests and Wilcoxon signed-rank tests were used for within-group comparisons; for data that did not conform, the rank sum test was used. For count data, frequencies or percentages (%) were used for representation, and chi-square tests were used for between-group comparisons. For ranked data, the rank sum test was used for between-group comparisons. When P < 0.05, the difference between the two groups of data was considered statistically significant.

[0143] VIII. Research results:

[0144] 1. Comparison of the genders of the two groups of patients:

[0145] 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, accounting for 52.73%, and 26 females, accounting for 47.27%. There were 53 patients in the control group, including 25 males, accounting for 47.17%, and 28 females, accounting for 52.83%. After X2 test, X2 = 0.016 and P = 0.992 > 0.05, indicating that there was no statistically significant difference in the genders of the two groups of patients, suggesting that the gender data of the two groups were comparable. See Table 1.

[0146] Table 1: Comparison of the genders of the two groups of patients:

[0147] .

[0148] 2. Comparison of the ages of the two groups of patients:

[0149] The ages of the two groups of patients were compared. The maximum age of the patients in the treatment group was 86 years old, the minimum age was 51 years old, and the average age was 69.65 ± 7.86 years old; the maximum age of the patients in the control group was 86 years old, the minimum age was 53 years old, and the average age was 71.9 ± 7.30 years old. After the rank sum test, P = 0.122 > 0.05, indicating that there was no statistically significant difference in the ages of the two groups of patients, suggesting that the age data of the two groups were comparable. See Table 2.

[0150] Table 2: Comparison of the ages of the two groups of patients:

[0151] .

[0152] ​3. Comparison of Traditional Chinese Medicine (TCM) syndrome scores of patients before and after treatment:

[0153] Comparing the data within the groups: After treatment, the TCM syndrome scores of both groups decreased. Through t-test, it was obtained that for the treatment group, t = 10.319, P < 0.001, and for 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 of patients before and after treatment, suggesting that both interventions were effective.

[0154] Comparing the data between the groups: Through t-test, it was obtained that the difference in the TCM syndrome scores of the two groups of patients before treatment was t = 0.016, P > 0.05, without statistical significance, indicating that the TCM syndrome score data of the two groups before treatment were comparable; the difference in the TCM syndrome scores of the two groups of patients after treatment was t = -3.49, P = < 0.05, with statistical significance, suggesting that the treatment group had a more obvious effect in improving the TCM syndromes of patients compared with the control group. See Table 3.

[0155] Table 3: Comparison of TCM syndrome scores of two groups of patients before and after treatment (points):

[0156] 。

[0157] 4. Comparison of mMRC dyspnea scores of two groups of patients before and after treatment:

[0158] Comparing the data within the groups: After treatment, the mMRC dyspnea scores of both groups of patients decreased. Through t-test, it was obtained that for the treatment group, t = 14.152, P < 0.001, and for the control group, t = 14.565, P < 0.001, indicating that there was a statistically significant difference in the mMRC scores of the two groups of patients before and after treatment, suggesting that both interventions were effective.

[0159] 001Comparing the data between the groups: Through t-test, it was obtained that the difference in the mMRC dyspnea scores of the two groups of patients before treatment was t = 0, P > 0.05, without statistical significance, indicating that the mMRC dyspnea score data of the two groups before treatment were comparable; the difference in the mMRC dyspnea scores of the two groups of patients after treatment was t = -6.21, P = < 0.001, with statistical significance, suggesting that the treatment group had a more obvious effect in improving the mMRC dyspnea scores of patients compared with the control group. Details are shown in Table 4.

[0160] Table 4: Comparison of mMRC scores of two groups of patients before and after treatment (points):

[0161] 。

[0162] 5. Comparison of CAT scores of patients with chronic obstructive pulmonary disease assessment test:

[0163] Compare the data within the groups: After treatment, the CAT scores of both groups decreased. After t-test, it was found that in the treatment group, t = 8.30, P < 0.001, and in 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 both interventions were effective.

[0164] Compare the data between the groups: After t-test, it was found that the difference in CAT scores before treatment between the two groups of patients was t = 0, P > 0.05, without statistical significance, indicating that the CAT score data before treatment in the two groups were comparable; the difference in CAT scores after treatment between the two groups of patients was t = -16.27, P < 0.05, with statistical significance, suggesting that the treatment group had a more obvious effect in improving the CAT scores of patients compared with the control group. See Table 5 for details.

[0165] Table 5: Comparison of CAT scores in the Chronic Obstructive Pulmonary Disease Assessment Test for patients (points)

[0166] 。

[0167] 6. Comparison of the levels of Forced Expiratory Volume in One Second (FEV1) in the two groups of patients before and after treatment (%):

[0168] Compare the data within the groups: After treatment, the FEV1 levels of both groups of patients increased. After rank sum test, it was found that in the treatment group, Z = -6.49, P < 0.001, and in 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.

[0169] Compare the data between the groups: After t-test, it was found that the difference in FEV1 levels before treatment between the two groups of patients was t = 0.17, P > 0.05, without statistical significance, indicating that the FEV1 data before treatment in the two groups were comparable; the difference in FEV1 levels after treatment between the two groups of patients was t = 4.8, P < 0.05, with statistical significance, suggesting that the treatment group had a more obvious effect in increasing the FEV1 of patients compared with the control group. See Table 6 for details.

[0170] Table 6: Comparison of Forced Expiratory Volume in One Second (FEV1) in the two groups of patients before and after treatment (L / S):

[0171] 。

[0172] 7. Comparison of the FEV1 / FVC levels in the two groups of patients before and after treatment:

[0173] Compare the data within the groups: After treatment, the FEV1 / FVC levels of both groups of patients increased. After the rank sum test, it was found that in the treatment group, Z = -8.58, P < 0.001, and in the control group, Z = -4.775, P < 0.001. This indicates that there is a statistically significant difference in the FEV1 / FVC levels of the two groups of patients before and after treatment, suggesting that both interventions are effective.

[0174] Compare the data between the groups: After the t-test, it was found that the difference in the FEV1 / FVC levels of 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 the FEV1 / FVC levels of the two groups of patients after treatment was t = 2.69, P = < 0.05, which was statistically significant, suggesting that the treatment group had a more obvious effect in improving the FEV1 / FVC of patients. For details, see Table 7.

[0175] Table 7: Comparison of FEV1 / FVC of two groups of patients before and after treatment (%)

[0176] 。

[0177] 8. Comparison of the six-minute walking distance (6MWD) levels of two groups of patients before and after treatment

[0178] Compare the data within the groups: After treatment, the 6MWD levels of both groups increased. After the t-test, it was found that in the treatment group, t = -18.481, P < 0.001; in the control group, Z = -13.149, P = < 0.001. This indicates that there is a statistically significant difference in the 6MWD levels of the two groups of patients before and after treatment, suggesting that both interventions are effective. Compare the data between the groups: After one-way ANOVA, it was found that the difference in the 6MWD levels of the two groups of patients before treatment was not statistically significant (t = 0.038, P > 0.05), indicating that the 6MWD data of the two groups before treatment were comparable; after the rank sum test, the difference in the 6MWD levels of the two groups of patients after treatment was statistically significant (z = 2.58, P < 0.001), suggesting that the treatment group had a more obvious effect in increasing the six-minute walking distance level of patients. See Table 8.

[0179] Table 8: Comparison of six-minute walking distance (6MWD) of two groups of patients before and after treatment

[0180] 。

[0181] 9. Efficacy of patients

[0182] After the completion of the entire treatment course of this study, there were 55 patients in the treatment group. Among them, 8 cases had clinical control, 25 cases had marked efficacy, 19 cases had effective results, and 3 cases had ineffective results. The total effective rate was 94.55%. There were 53 patients in the control group. Among them, 6 cases had clinical control, 23 cases had marked efficacy, 15 cases had effective results, and 9 cases had ineffective results. The total effective rate was 83.02%. Chi-square test was used to analyze the total effective rates of the two groups. After chi-square test, we got H c = 8.941, P < 0.001, indicating that there was a statistically significant difference in the total effective rates between the two groups, suggesting that the total effective rate of the treatment group was higher than that of the control group. The details are shown in Table 9.

[0183] Table 9: Comparison of clinical efficacy:

[0184] .

[0185] Note: Total effective rate (%) = (clinical control + marked efficacy + effective) / number of patients × 100%.

[0186] 10. Safety assessment:

[0187] (1) Drug safety assessment:

[0188] During the treatment before, during, and after the treatment, the two groups of patients underwent routine examinations of vital signs, blood, urine, and feces, as well as liver and kidney functions, electrocardiogram, etc. to evaluate the drug safety. No abnormal results were found that were normal before treatment but abnormal after treatment, indicating that the drug was safe.

[0189] (2) Adverse reactions of patients: Only 2 cases had adverse reactions during the period, and they all improved after symptomatic treatment.

[0190] Typical treatment cases

[0191] Case 1: Patient 1, 60 years old, male, married. Chief complaint: "Repeated cough and asthma for more than 10 years".

[0192] Current medical history: Chest tightness and shortness of breath for 10 years. Now, after getting cold, there is occasional cough, no sputum, chest tightness and shortness of breath have improved significantly compared with before, occasional general weakness, no obvious dry mouth and bitter taste, no low back pain, no dizziness and headache, fear of cold, normal defecation and urination, normal appetite and sleep. The tongue is dark red, the tongue coating is white with cracks, the sublingual veins are slightly tortuous, and the pulse is thready.

[0193] Previous examinations and tests: On October 17, 2023, a chest CT examination at an external hospital found pulmonary emphysema, scattered chronic inflammation and proliferative foci in the left lung, which were similar to the previous ones, and a nodular shadow of 0.5*1 cm could be seen in the lower left lung. On August 8, 2022, the pulmonary function at an external hospital showed: Pulmonary function after lung dilation: Severe impairment of pulmonary ventilation function (mixed type); Severe reduction of pulmonary diffusion function; FeNO: 35 ppb. On April 5, 2023, a chest CT at an external hospital showed: Changes of chronic bronchitis and pulmonary emphysema; Scattered chronic inflammation in the left lung; A nodule of 0.5*1 cm in the lower left lung.

[0194] Pulmonary function: On 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 type ventilatory dysfunction; Decrease in maximum ventilation volume; Decrease in pulmonary diffusion function; Increase in residual / total ratio; Increase in airway resistance; Decrease in respiratory muscle strength; Negative bronchial dilation test.

[0195] Past history, personal history, family history, etc.: History of chronic obstructive pulmonary disease, regularly controlled with Budesonide and Formoterol. Smoking for 40 years, 1 pack / day, and has quit smoking for 6 years; The condition often relapses. No history of diabetes, heart disease or hypertension; Denied drug and food allergies; Denied family genetic history.

[0196] Auxiliary examinations: Body temperature (T) 37.3°C, heart rate (P) 100 beats / min, respiratory rate (R) 21 times / min, blood pressure (BP) 112 / 89 mmHg. Barrel chest, and a small amount of moist rales were heard in both lungs.

[0197] The patient is an elderly male, presenting with cough, wheezing and chest tightness. Due to long-term damage to the lungs, the functions of the lungs in governing qi and respiration are abnormal, leading to deficiency of lung qi, and the failure of the lungs to disperse and descend, thus causing the condition. Moreover, due to the deficiency of lung qi, the promotion of blood circulation is weak, the blood flow is slow, and stasis is formed, so the tongue is dull red and the sublingual veins are slightly tortuous. At the same time, due to the failure of the lungs to disperse and descend and the abnormal distribution of body fluids, phlegm is formed. The phlegm turbidity and stasis interact with each other and block the lung collaterals, resulting in unsmooth flow of lung qi and aggravating symptoms such as chest tightness and shortness of breath. Generally speaking, the patient is based on deficiency of lung qi and deficiency of both the lung and kidney, and marked by being attacked by exogenous pathogens and blockage of phlegm turbidity and stasis. During the stable stage of the disease, it is mainly deficiency of the root, manifested as deficiency symptoms such as insufficiency of lung qi and failure of the kidney to receive qi. After getting cold, exogenous pathogens trigger the latent phlegm and stasis inside, forming a syndrome of excess of the branch, presenting manifestations such as aggravated cough, chest tightness and shortness of breath, belonging to the syndrome of deficiency of the root and excess of the branch.

[0198] Traditional Chinese medicine diagnosis: Deficiency of both the lung and kidney, diagnosed as the stable stage of chronic obstructive pulmonary disease.

[0199] Intervention measures: Use the traditional Chinese medicine decoction in Example 1. Take 1 dose per day, decoct with water and take it warm twice a day, morning and evening, for a total of 14 doses.

[0200] Condition changes and prognosis:

[0201] Second diagnosis: The patient reported that after taking the above prescription, the chest tightness had significantly improved, with occasional coughing and wheezing. The feelings of chilliness and fatigue were alleviated compared to before. The appetite was normal, the sleep was normal, and the bowel and bladder movements were normal. Traditional Chinese medicine tongue and pulse conditions: The tongue was pale red, the coating was white, and the pulse was thready. Continue to take the above prescription once a day for a total of 14 doses. During the follow-up half a year later, the sense of shortness of breath after activities was not obvious, there was no fever, the physical strength had increased, and the mental state was good.

[0202] Case 2: Patient 2, male, 63 years old. Chief complaint: "Repeated coughing and wheezing for more than 5 years."

[0203] Current medical history: The condition was stable. Currently, there was coughing, chest tightness and shortness of breath after activities, less phlegm, expectorating white phlegm with a little yellow, slightly wheezing, defecating 2 times a day, no chilliness or fever, the tongue was dull, the coating was white and greasy, there were cracks in the middle, the sublingual collaterals were slightly tortuous, and the pulse was thready.

[0204] Past medical history, personal history, family history, etc.: There was a 10-year history of COPD in the past. Coronary heart disease and diabetes were denied. Infectious diseases such as hepatitis were denied; Family genetic history was denied.

[0205] Auxiliary examinations: Pulmonary function examinations: On October 25, 2023: VCmax (2.86, 74%); FVCex (2.86, 77%); FEV1 (1.45, 51%); FEV1 / VCmax (51, 64%); FEV1 / FVCex (51, 64%);

[0206] Severe mixed pulmonary ventilation dysfunction.

[0207] Traditional Chinese medicine diagnosis: Deficiency of both the lung and kidney, stasis blocking the collaterals syndrome, diagnosed as the stable stage of chronic obstructive pulmonary disease.

[0208] Intervention measures: Use the traditional Chinese medicine decoction in Example 3. Take 1 dose per day, decoct with water and warm it for oral administration twice in the morning and evening, for a total of 14 doses.

[0209] Condition changes and prognosis:

[0210] Second diagnosis: Slightly wheezing, aggravated after activities, the condition is prone to recurrence when exposed to cold, hands and feet are slightly cold, the tongue is red, the coating is yellow and greasy, there are cracks in the middle, the sublingual collaterals are slightly tortuous, and the pulse is thready. During the follow-up half a year later, the patient had slightly chest tightness, and other discomforts were not obvious.

[0211] The clinical trial research of the present invention shows that the traditional Chinese medicine composition of the present invention has obvious improvement in the symptoms of the stable stage of chronic obstructive pulmonary disease, including improving symptoms such as coughing, expectorating phlegm, and chest tightness, shortening the cough remission time and cure time of patients, improving the quality of life of patients and pulmonary function indicators, etc., all having significant curative effects, and no results that were normal before treatment but abnormal after treatment were found, and the drug safety is good.

[0212] 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 foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements, or in the case where the technical features in the above embodiments do not conflict with each other, can be combined in the manner described in the embodiments, and these modifications, replacements or combinations do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for improving the symptoms in the stable stage of chronic obstructive pulmonary disease, characterized in that, The traditional Chinese medicine composition is prepared from a medicinal material composition comprising the following components by mass parts: 13 - 17 parts of stir-fried Astragalus membranaceus, 13.5 - 16.5 parts of Codonopsis pilosula, 9 - 11 parts of Rehmannia glutinosa, 13.5 - 16.5 parts of Cornus officinalis, 9 - 11 parts of Morus alba root bark, 9 - 11 parts of Platycodon grandiflorum, 5 - 7 parts of stir-fried Glycyrrhiza uralensis, 5 - 7 parts of Pheretima aspergillum, 27 - 33 parts of Dioscorea nipponica, 16 - 18 parts of Elaeagnus root, 7 - 9 parts of calcined Fluorite, and 13.5 - 16.5 parts of Ophiopogon japonicus.

2. The traditional Chinese medicine composition according to claim 1, wherein The medicinal material composition comprises: 15 parts of stir-fried Astragalus membranaceus, 15 parts of Codonopsis pilosula, 10 parts of Rehmannia glutinosa, 15 parts of Cornus officinalis, 10 parts of Morus alba root bark, 10 parts of Platycodon grandiflorum, 6 parts of stir-fried Glycyrrhiza uralensis, 6 parts of Pheretima aspergillum, 30 parts of Dioscorea nipponica, 17 parts of Elaeagnus root, 8 parts of calcined Fluorite, and 15 parts of Ophiopogon japonicus; or, The medicinal material composition comprises: 16 parts of stir-fried Astragalus membranaceus, 16 parts of Codonopsis pilosula, 9 parts of Rehmannia glutinosa, 14 parts of Cornus officinalis, 10 parts of Morus alba root bark, 10 parts of Platycodon grandiflorum, 7 parts of stir-fried Glycyrrhiza uralensis, 5 parts of Pheretima aspergillum, 32 parts of Dioscorea nipponica, 18 parts of Elaeagnus root, 9 parts of calcined Fluorite, and 16.5 parts of Ophiopogon japonicus; or, The medicinal material composition comprises: 17 parts of stir-fried Astragalus membranaceus, 16.5 parts of Codonopsis pilosula, 11 parts of Rehmannia glutinosa, 16.5 parts of Cornus officinalis, 9 parts of Morus alba root bark, 9 parts of Platycodon grandiflorum, 5 parts of stir-fried Glycyrrhiza uralensis, 7 parts of Pheretima aspergillum, 33 parts of Dioscorea nipponica, 16 parts of Elaeagnus root, 8 parts of calcined Fluorite, and 14 parts of Ophiopogon japonicus; or, The medicinal material composition comprises: 13 parts of stir-fried Astragalus membranaceus, 13.5 parts of Codonopsis pilosula, 11 parts of Rehmannia glutinosa, 13.5 parts of Cornus officinalis, 11 parts of Morus alba root bark, 11 parts of Platycodon grandiflorum, 7 parts of stir-fried Glycyrrhiza uralensis, 5 parts of Pheretima aspergillum, 27 parts of Dioscorea nipponica, 16 parts of Elaeagnus root, 7 parts of calcined Fluorite, and 13.5 parts of Ophiopogon japonicus.

3. The traditional Chinese medicine composition according to claim 1, wherein: The medicinal material composition further includes 12 - 15 parts of Houttuynia cordata.

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

5. The traditional Chinese medicine composition according to claim 1, wherein The traditional 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 clear water, dry them, and then sterilize them by microwave; Soak Dioscorea nipponica in warm water at 40 - 50 °C for 10 - 15 min to soften the fibers, and then cut stir-fried Astragalus membranaceus, Codonopsis pilosula, and Dioscorea nipponica into slices with a thickness of 3 - 5 mm; Bake Pheretima aspergillum until the water content ≤ 8%, crush it, soak it in 70 - 75% ethanol for 20 - 30 min, and filter to remove the ethanol; First, put the calcined Fluorite into water and decoct for 30 - 50 min, then soak all the remaining medicinal materials in water for 30 - 40 min, add water 2 - 3 cm above the drug surface, decoct for the first time for 15 - 20 min, pour out 1 / 2 of the medicinal liquid, add warm water for the second decoction for 25 - 35 min, pour out all the medicinal liquid, and mix the two decoctions evenly to obtain the decoction.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine composition comprises the following steps: Step 1: Weigh the medicinal materials according to the components of the medicinal material composition, rinse the floating soil with clear water, dry them, and then sterilize them by microwave; Step 2: Dioscorea nipponica Makino is soaked in warm water at 40 - 50 °C for 10 - 15 min to soften the fibers, and then Dioscorea nipponica Makino, Astragalus membranaceus (Fisch.) Bunge var. mongholicus (Bunge) Hsiao & K. C. Hsia, and Codonopsis pilosula are cut into slices with a thickness of 3 - 5 mm; Calcinated Fluoritum is pulverized into fine powder of 80 meshes; Pheretima is baked until the water content ≤ 8%, pulverized, and then infiltrated with 70 - 75% ethanol for 20 - 30 min to inactivate enzymes and reduce the fishy smell, and then the ethanol is filtered off; Step 3: All the medicinal material compositions are mixed with 8 times the mass of water, and 5 wt% of rice vinegar or citric acid is added to the water. After pre - soaking for 0.5 - 1 h, the temperature is raised to 90 - 95 °C and kept warm for 30 - 40 min with synchronous stirring. Then the temperature is lowered to 60 - 70 °C, and 0.1 wt% of cellulase is added and enzymolyzed for 40 - 70 min. During the extraction process, a condensation reflux device is connected to the top of the extraction tank to collect the volatile components of Mori Cortex and Platycodonis Radix, and the collected condensate is finally added back to the medicinal liquid; Step 4: Under the conditions of a vacuum degree of - 0.08 MPa and a temperature of 55 - 65 °C, the extract is concentrated to obtain a concentrated paste with a relative density of 1.25 - 1.30 at 70 °C; Step 5: Adjuvants are added to the concentrated paste, and it is processed according to the preparation procedures of capsules, tablets, pills, ointments or powders. The finished product is sterilized by γ - ray irradiation with a dose of 8 - 10 kGy and then packaged.

7. The traditional Chinese medicine composition according to claim 6, wherein: The traditional Chinese medicine composition is a powder, and the method of Step 5 is: The concentrated paste is mixed with dextrin and microcrystalline cellulose according to a mass ratio of 1:0.9:0.3, and made into particles of 80 - 100 meshes with a water content ≤ 5% through a centrifugal spray drying tower; or, The traditional Chinese medicine composition is a capsule, and the method of Step 5 is: The concentrated paste is mixed with dextrin and microcrystalline cellulose according to a mass ratio of 1:0.9:0.3, directly made into particles of 80 - 100 meshes through a centrifugal spray drying tower, and then filled into capsules; or, The traditional Chinese medicine composition is a tablet, and the method of Step 5 is: The concentrated paste is evenly spread on a stainless - steel tray and placed in a vacuum drying oven to dry until the water content ≤ 5% to obtain a dry paste. The dry paste is processed by a jet mill to a particle size of 80 - 100 meshes, and after sieving, it is mixed evenly with adjuvants, and 5% HPMC solution is sprayed to granulate, controlling the water content of the wet granules to be 8 - 12%. The wet granules are dried in a fluidized - bed dryer until the water content ≤ 3% to obtain dry granules. The dry granules are sized by an oscillating sieve, magnesium stearate is added for secondary mixing, and then pressed into tablets on a tablet press. For the qualified tablets after inspection, they are coated with HPMC - based coating solution to obtain tablets.

8. The traditional Chinese medicine composition according to claim 1, wherein The processing method of the calcinated Fluoritum is: The raw ore is broken into small pieces, and Fluoritum is calcined in a vacuum at a calcination temperature of 750 - 800 °C for 2 - 3 h.