A traditional Chinese medicine composition, preparation and application for treating lung flaccidity of qi-yin deficiency type

Abstract

The application discloses a traditional Chinese medicine composition, preparation and application for treating lung flaccidity of qi-yin deficiency type, and the traditional Chinese medicine composition is composed of ginseng 6-10g, canxi 1, astragalus 8-15g, ophiopogon 10-15g, prepared rehmannia 8-15g, schisandra 10-15g, purple yam 6-10g, mulberry bark 10-15g, dried tangerine or orange peel 10-20g and licorice 9-12g by weight. The traditional Chinese medicine composition is suitable for lung flaccidity of qi-yin deficiency type. The traditional Chinese medicine composition can also be used for treating deficiency heat syndrome, deficiency cold syndrome or lung collateral blockage syndrome by adding or subtracting on the basis of the prescription to achieve the purpose of treating diseases. The prescription is aimed at lung flaccidity caused by qi-yin deficiency, yin deficiency and fire exuberance, lung collateral blockage and long-term deficiency and yang damage, and mainly takes the basic therapeutic principle of tonifying qi and nourishing yin, and also has the basic therapeutic principle of promoting qi and resolving phlegm, and has the action of treating symptoms and root causes simultaneously. Clinical research finds that the medicine composition can relieve clinical symptoms of lung flaccidity patients and is relatively safe.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, preparation and application for treating pulmonary atrophy of the Qi and Yin deficiency type. Background Technology

[0002] Pulmonary atrophy refers to the weakening and non-use of the lung lobes, clinically characterized by coughing up turbid saliva and phlegm. It is a chronic debilitating disease of the lungs, primarily referring to pulmonary fibrosis in modern medicine. The *Jinkui Yaolue Xindian* (Essentials from the Golden Cabinet) states, "Atrophy means withering, like the withering and non-bearing of grass and trees." The term pulmonary atrophy first appeared in Zhang Zhongjing's *Jinkui Yaolue*, which provides a relatively systematic introduction to the main symptoms, etiology, pathogenesis, and differentiation of pulmonary atrophy. Sun Simiao of the Tang Dynasty, in his *Qianjin Yaofang* (Essential Prescriptions Worth a Thousand Gold Pieces), divided pulmonary atrophy into two categories: heat in the upper burner and deficiency-cold in the lungs. He believed that "although pulmonary atrophy has cold and heat distinctions, there is never an example of excess heat." He proposed that deficiency-cold pulmonary atrophy could be treated with ginger and licorice decoction or licorice decoction, while deficiency-heat pulmonary atrophy could be treated with roasted licorice decoction or ophiopogon decoction. Physicians throughout history have recognized that pulmonary atrophy is a chronic progression of various pulmonary diseases. Lung abscess, tuberculosis, chronic cough, asthma, and other conditions that damage the lungs can all potentially develop into pulmonary atrophy. Tang Dynasty physician Wang Tao, in his *Waitai Miyao* (Secret Essentials from the Outer Terrace), under the section on cough, quotes Xu Renze as saying: "Prolonged cough due to lung qi will eventually lead to pulmonary atrophy. Its symptoms are not limited by the seasons or temperature; the cough is constant day and night, with sputum as white as snow, fine and sticky, accompanied by shortness of breath, alternating chills and fever, and occasional attacks. The lips, mouth, throat, and tongue are dry and parched, and sometimes there is spitting blood. Gradually, one becomes thin and emaciated, with reddish urine, bluish-white urine, and hair standing on end. This is also a sign of 'steaming' (a condition where the body is overworked and fatigued), which, due to overwork and heat, damages the lung yin, and further development leads to pulmonary atrophy." Ming Dynasty physician Wang Kentang, in his *Zhengzhi Zhunsheng* (Standards of Diagnosis and Treatment), under the section on various qi disorders, states: "Prolonged cough with hemoptysis leads to pulmonary atrophy." Chen Shigong, in his *Orthodox Manual of Surgery: On Lung Abscess*, states: "Prolonged cough and overexertion, coughing up phlegm and blood, alternating chills and fever, emaciation, coughing up purulent sputum, hoarseness and sore throat, these symptoms can progress to pulmonary atrophy." This indicates that after a lung abscess ulcerates, the lingering heat and toxins damage yin and deplete qi, potentially leading to pulmonary atrophy. Zhang Lu, in his *Zhang's Medical Treatise: Pulmonary Atrophy*, summarizes its treatment in seven aspects: "treat slowly and steadily, generate stomach fluids, moisten lung dryness, relieve rebellious qi, clear accumulated phlegm, stop turbid saliva, replenish true qi…disperse heat," aiming to "open the small ducts of the lung" and "restore the lung's cleanliness." The principles are profound and highly practical. Shen Jin'ao's "Miscellaneous Diseases: Origins and Development - Lung Diseases" further supplements the prescriptions and contraindications for pulmonary atrophy: "When the symptoms appear, there will be alternating chills and fever, spontaneous sweating, shortness of breath, restlessness and excessive spitting, or with red streaks of pus and blood. It should be treated urgently. Generally speaking, the treatment for this disease is mainly to nourish the lungs, nourish the qi, nourish the blood, clear the lungs, and reduce fire."

[0003] Clinical observations show a significant increase in the incidence of pulmonary atrophy, possibly due to the long-term presence of various respiratory viruses and repeated infections, which repeatedly stimulate the pulmonary interstitium. Although significant progress has been made in the treatment of viral pneumonia, a considerable knowledge gap remains regarding the long-term sequelae of these patients. Therefore, how to better prevent and treat pulmonary atrophy has become an important topic in contemporary medical research. In response, Traditional Chinese Medicine (TCM) treatments, characterized by principles of invigorating Qi, nourishing Yin, and promoting blood circulation, are becoming an increasingly worthwhile approach in clinical practice. Furthermore, with the progress of human society and the development of science and technology, the medical model has shifted from the "biomedical model" to the "biopsychosocial model." TCM embodies this new direction of medical development, and finding safe and effective drugs for the prevention and treatment of pulmonary atrophy within TCM to improve patients' quality of life and prolong lifespan is an inevitable trend in modern medical research. Summary of the Invention

[0004] The first objective of this invention is to provide a traditional Chinese medicine composition for treating pulmonary atrophy of the Qi and Yin deficiency type, and the second objective is to provide a pharmaceutical preparation of the traditional Chinese medicine composition and its uses.

[0005] The first objective of this invention is achieved as follows: the traditional Chinese medicine composition for treating pulmonary atrophy of the Qi and Yin deficiency type is composed of 6-10g of ginseng, 1 piece of umbilicus, 8-15g of astragalus, 10-15g of ophiopogon japonicus, 8-15g of rehmannia glutinosa, 10-15g of schisandra chinensis, 6-10g of aster tataricus, 10-15g of mulberry bark, 10-20g of tangerine peel, and 9-12g of licorice.

[0006] The second objective is achieved as follows: the pharmaceutical preparation of the traditional Chinese medicine composition for treating pulmonary atrophy of qi and yin deficiency type is prepared by adding medically acceptable excipients to the traditional Chinese medicine composition and preparing it into any one of the following: decoction, granules, pills, tablets, capsules, ointments, syrups, powders, and powders.

[0007] The application of the traditional Chinese medicine composition is in the preparation of drugs for treating pulmonary atrophy due to deficiency of both qi and yin.

[0008] The inventor's research found that pulmonary flaccidity is a disease caused by multiple factors and involves multiple internal organs. The term "flaccidity" implies withering. Its etiology and pathogenesis include two aspects. First, deficiency of the lung affecting the kidney: prolonged coughing and wheezing consume qi and damage yin. The mutual nourishment between the lung and kidney fails, leading to deficiency of kidney yin. The upward flaming of deficient fire causes lung heat, which in turn scorches yin fluid, resulting in dryness of the lung and depletion of body fluids. The lung loses nourishment and develops into pulmonary flaccidity. This is what is described in "Plain Questions: Treatise on Flaccidity Disorders": "When the lung heat causes the leaves of the lung to wither, the skin and hair become weak, thin, and withered, leading to flaccidity and weakness of the lower limbs." "Essential Secrets of the Golden Chamber - Cough Disorders" also states: "Prolonged cough may develop into pulmonary flaccidity." In addition, inhalation of dry qi of minerals and stones through the mouth and nose into the lung can damage yin and scorch collaterals, also causing the lung to lose nourishment and resulting in pulmonary flaccidity. Second, deficiency of the lung affecting the spleen: deficiency of lung qi causes the son organ (the lung) to rob qi from the mother organ (the spleen), resulting in deficiency of middle-jiao qi. The stomach is the sea of water and grains. The spleen disperses body fluids and transports them upward to the lung. The spleen transports the body fluids for the stomach, and the lung governs the flow of qi in all vessels and distributes the qi throughout the body. Deficiency of the spleen and stomach leads to depletion of body fluids, which cannot be transported upward, resulting in dryness of the lung and depletion of body fluids. Just as stated in "Medical Laws - Pulmonary Flaccidity and Lung Abscess Disorders": "Pulmonary flaccidity... is always caused by the failure of the true fluids in the stomach to be transported to the lung, causing the lung to lose nourishment and gradually become dry and withered." Therefore, the flaccidity disorder in the upper jiao is closely related to the spleen and stomach in the middle jiao and the kidney water in the lower jiao, and they influence each other, which coincides with the holistic concept of traditional Chinese medicine.

[0009] As described above, "deficiency" is the basic pathogenesis of pulmonary flaccidity, and deficiency of lung qi is the core factor of lung deficiency. It is the causative factor for all clinical manifestations of pulmonary flaccidity. That is, on the basis of qi deficiency, the disease gradually develops, and then manifestations of yin deficiency and blood stasis appear. "Classic of Difficult Issues - Difficult Issue 8" states: "Qi is the root of a person... Deficiency of qi leads to various diseases." "Plain Questions: Treatise on Painful Obstruction" also states: "All diseases originate from qi." The lung is the master of qi, governing the qi of the whole body, covering all the zang-fu organs, and being responsible for defending the exterior. It is like a fence for the body. Therefore, exogenous pathogens easily enter through the mouth and nose and first attack the lung. Or due to congenital endowment deficiency, or due to prolonged illness damaging qi, or due to old age and physical weakness, or due to exogenous pathogens, it can lead to deficiency of lung qi, looseness of the interstices, and failure to defend the exterior. The dispersing and descending functions of the lung are impaired, blood circulation is不畅, and the qi transformation of body fluids is disordered. Eventually, phlegm and blood stasis obstruct the lung, resulting in coughing and restlessness. Therefore, in clinical practice, methods such as supplementing qi and nourishing yin or supplementing qi and activating blood circulation are often used for comprehensive treatment. When the lung is deficient, it robs qi from the mother organ above and fails to nourish the kidney yin below, and then the three organs of the lung, spleen, and kidney all become deficient. In patients with deficiency of lung qi, qi deficiency leads to blood stasis, manifested as cyanosis of the lips and loss of luster of the lips and nails; when the son organ is deficient, it must rob qi from the mother organ to nourish itself. In patients with deficiency of spleen qi, phlegm dampness is internally generated, and turbid saliva is expectorated, with fine foam being thick and sticky; due to the mutual nourishment between the lung and kidney, deficiency of the lung fails to nourish the kidney yin, resulting in yin deficiency with hectic fever and emaciation. This is the manifestation of pulmonary flaccidity turning from deficiency to excess ( Figure 1 ). Therefore, deficiency is the basic cause, and excess is the clinical symptom. That is, pulmonary flaccidity is a syndrome of deficiency in origin and excess in manifestation. For deficiency, tonifying methods should be used. When formulating prescriptions, herbs for tonifying deficiency should be the main treatment, supplemented by herbs for relieving cough, descending qi, and calming wheezing.

[0010] This invention relates to a traditional Chinese medicine composition targeting pulmonary atrophy caused by recurrent lung infections, chronic damage, or prolonged cough and asthma, leading to deficiency of both lung qi and yin, yin deficiency with exuberant fire, and obstruction of the lung collaterals. The composition comprises ginseng, astragalus, bupleurum, and ophiopogon japonicus, which tonify lung qi, nourish yin, and generate fluids, serving as the principal herbs. Ginseng is also a key herb for tonifying the spleen; rehmannia nourishes the kidneys and replenishes essence. The *Medical Prescriptions Collection* states: "When ginseng and astragalus are used for lung deficiency, the spleen is the mother of the lungs, and qi is the mother of water; when deficient, one tonifies the mother. Rehmannia is used because the kidneys are the children of the lungs; when the children are deficient, they will steal qi from the mother to nourish themselves. Therefore, kidney-tonifying herbs are used first to nourish the water element, and rehmannia is also an excellent phlegm-resolving agent." Schisandra chinensis astringes lung qi, serving as the assistant herb; aster, mulberry bark, and tangerine peel promote qi circulation, resolve phlegm, stop cough, and relieve asthma, serving as the adjuvant herbs; licorice harmonizes the other herbs and enhances their function. The combined herbs work synergistically to tonify lung qi, stop cough, and relieve asthma.

[0011] This invention's herbal composition treats both the root cause and symptoms of pulmonary atrophy due to Qi and Yin deficiency, simultaneously tonifying both Qi and Yin. Modifications can be made to address concurrent symptoms such as deficiency-heat, deficiency-cold, or lung meridian obstruction, achieving the goal of individualized treatment. The formula of this invention targets pulmonary atrophy caused by Qi and Yin deficiency, Yin deficiency with exuberant fire, and lung meridian obstruction, primarily focusing on tonifying Qi and nourishing Yin, while also relieving cough and resolving phlegm. It emphasizes tonifying Qi, promoting its flow without stagnation, while nourishing Yin and astringing the lungs, relieving cough and resolving phlegm, fully leveraging the synergistic effects of the herbs. This invention's herbal composition is precisely formulated, with mild and gentle properties, tonifying without causing stagnation, and promoting circulation without dispersing. It can improve lung function and exercise tolerance in patients with pulmonary atrophy, exhibiting strong clinical applicability, high acceptance, and good safety. Attached Figure Description

[0012] Figure 1 The etiology and pathogenesis of pulmonary atrophy in traditional Chinese medicine. Detailed Implementation

[0013] The present invention will be further described below with reference to embodiments, but this is not intended to limit the present invention in any way. Any modifications or substitutions made based on the technical teachings of the present invention shall fall within the protection scope of the present invention.

[0014] This invention discloses a traditional Chinese medicine composition for treating pulmonary atrophy of the Qi and Yin deficiency type, comprising, by weight: 6-10g ginseng, 1 piece of *Kanqi* (a type of medicinal herb), 8-15g astragalus, 10-15g *Ophiopogon japonicus*, 8-15g *Rehmannia glutinosa*, 10-15g schisandra chinensis, 6-10g aster tataricus, 10-15g mulberry bark, 10-20g dried tangerine peel, and 9-12g licorice.

[0015] The aforementioned Chinese herbal composition, with the addition of 6-10g of Adenophora stricta, 5-10g of Bambusa textilis, 6-10g of Polygonatum odoratum, and 10-15g of Phragmites communis, is suitable for those with both Qi and Yin deficiency, accompanied by deficiency-heat syndrome; in order to achieve the effect of nourishing Yin and clearing heat. The combination of the two enhances the effects of tonifying Qi and nourishing Yin, clearing heat, moistening the lungs and relieving cough.

[0016] The aforementioned traditional Chinese medicine composition, with the addition of 6-10g of dried ginger, 8-15g of jujube, 10-15g of stalactite, and 5-10g of gecko powder, is suitable for those with both qi and yin deficiency, accompanied by deficiency-cold syndrome; it has achieved the effect of warming and tonifying the lungs and kidneys. The combination of the two enhances the ability to replenish qi and nourish yin, warm the lungs and resolve phlegm, and tonify the kidneys and promote qi absorption.

[0017] The traditional Chinese medicine composition contains 1-2 centipedes, 2-4 scorpions, 6-10g of silkworm pupae, and 6-10g of earthworms. It is suitable for those with deficiency of both qi and yin, accompanied by obstruction of the lung collaterals. It has achieved the effects of promoting blood circulation, removing blood stasis, and clearing the collaterals. The combination of the two enhances the effects of tonifying qi and nourishing yin, promoting blood circulation, removing blood stasis, and clearing the lung collaterals.

[0018] The present invention also provides a pharmaceutical preparation based on the traditional Chinese medicine composition for treating pulmonary atrophy of qi and yin deficiency, wherein the traditional Chinese medicine composition is formulated with medically acceptable excipients and prepared into any one of the following: decoction, granules, pills, tablets, capsules, ointments, syrups, powders and powders.

[0019] The granules are prepared by the following steps:

[0020] (1) Decoction: Add water to each herb in the formula at a weight ratio of 1:6~8 and decoct 1 to 3 times, each time for 30 to 60 minutes, and combine the decoction liquid;

[0021] (2) Concentration: The obtained decoction is concentrated into a thick paste at 50~75℃ and -0.02~0.06MPa vacuum. The density of the thick paste at 50℃ is 1.20g / ml.

[0022] (3) Drying: Dry the thick paste at 60~70℃ and -0.02~-0.06MPa vacuum to form a dry paste for later use;

[0023] (4) The dry paste is pulverized and passed through a 100-mesh sieve to obtain mixed dry paste powder. 10-30g of granulation excipients are added and mixed evenly. An appropriate amount of 70%-90% ethanol is added, and wet granulation is performed. After drying, granules are obtained.

[0024] The granulation excipient is one or more of dextrin, maltodextrin, or sucrose.

[0025] The pills are prepared by the following steps:

[0026] (1) Decoction: Weigh each herb in the formula according to the formula amount, add water at a ratio of 1:6~10 and decoct 1~3 times, each time for 35~45 minutes, and combine the decoction liquid;

[0027] (2) Concentration: The obtained decoction is concentrated into a thick paste at 50~75℃ and -0.02~0.06MPa vacuum. The density of the thick paste at 50~60℃ is 1.20~1.35g / ml.

[0028] (3) Drying: Dry the thick paste at 50~75℃ and -0.02~0.06MPa vacuum to form a dry paste for later use;

[0029] (4) Pulverize the dry paste and pass it through a 100-mesh sieve to obtain mixed dry paste powder. Use water or an aqueous solution of ethanol with a concentration of 30% or less to form pills.

[0030] The present invention further provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating pulmonary atrophy of the Qi and Yin deficiency type.

[0031] Example 1

[0032] Formula: Ginseng 6g, one navel, Astragalus 10g, Ophiopogon japonicus 10g, Rehmannia glutinosa 10g, Schisandra chinensis 10g, Aster tataricus 6g, Morus alba root bark 15g, Citrus reticulata peel 15g, Glycyrrhiza uralensis 10g.

[0033] In the formula, each herb is decocted three times with water at a weight ratio of 1:10, each time for 60 minutes. The decoctions are then combined to obtain the decoction.

[0034] Example 2

[0035] Formula: Ginseng 10g, one navel, Astragalus 10g, Ophiopogon japonicus 10g, Rehmannia glutinosa 10g, Schisandra chinensis 10g, Aster tataricus 10g, Morus alba root bark 15g, Citrus reticulata peel 20g, Glycyrrhiza uralensis 9g.

[0036] The ingredients in the formula are decocted three times with water at a weight ratio of 1:6, each time for 30-60 minutes, and the decoctions are combined. The resulting decoctions are concentrated into a thick paste at 75℃ and a vacuum degree of -0.02~0.06MPa. The density of the thick paste at 60℃ is 1.35g / ml. The thick paste is dried into a dry paste at 60℃ and a vacuum degree of -0.02~-0.06MPa. The dry paste is pulverized and passed through a 100-mesh sieve to obtain a mixed dry paste powder. 10g of dextrin is added and mixed well. An appropriate amount of 70% ethanol is added, and the mixture is wet-granulated. After drying, the granules are obtained.

[0037] Example 3

[0038] Formula: Ginseng 8g, one navel, Astragalus 15g, Ophiopogon japonicus 10g, Rehmannia glutinosa 9g, Schisandra chinensis 10g, Aster tataricus 10g, Morus alba root bark 12g, Citrus reticulata peel 20g, Glycyrrhiza uralensis 9g.

[0039] Weigh each ingredient in the formula according to the prescribed amount, add water at a weight ratio of 1:8 and decoct twice, 60 minutes each time, and combine the decoctions. Concentrate the resulting decoction at 75℃ and under vacuum of -0.02~0.06MPa to form a thick paste. The density of the thick paste at 50℃ is 1.20g / ml. Dry the thick paste at 75℃ and under vacuum of -0.02~0.06MPa to form a dry paste. Crush the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Make pills with water to obtain pills.

[0040] Example 4

[0041] Formula: Ginseng 9g, one navel, Astragalus 10g, Ophiopogon japonicus 12g, Rehmannia glutinosa 10g, Schisandra chinensis 10g, Aster tataricus 10g, Morus alba root bark 15g, Citrus reticulata peel 20g, Glycyrrhiza uralensis 9g, Adenophora stricta 10g, Ophiopogon japonicus 10g, Polygonatum odoratum 10g, Phragmites communis rhizome 15g.

[0042] The ingredients in the formula are decocted three times with water at a weight ratio of 1:10, each time for 45 minutes, and the decoctions are combined. The resulting decoctions are concentrated into a thick paste at 65℃ under a vacuum of -0.02~0.06MPa. The density of the thick paste at 60℃ is 1.35g / ml. The thick paste is then dried at 65℃ under a vacuum of -0.02~-0.06MPa to obtain a dry paste. The dry paste is pulverized and passed through a 100-mesh sieve to obtain a mixed dry paste powder. 30g of maltodextrin is added and mixed well. An appropriate amount of 90% ethanol is added, and the mixture is wet-granulated and dried to obtain granules. This formula is suitable for deficiency of both qi and yin, with concurrent deficiency-heat syndrome; it aims to nourish yin and clear heat. The combination of the two ingredients enhances the effects of tonifying qi and nourishing yin, clearing heat, moistening the lungs, and relieving cough.

[0043] Example 5

[0044] Formula: Ginseng 10g, one navel, Astragalus 10g, Ophiopogon japonicus 10g, Rehmannia glutinosa 9g, Schisandra chinensis 15g, Aster tataricus 6g, Morus alba root bark 10g, Citrus reticulata peel 10g, Glycyrrhiza uralensis 10g, Adenophora stricta 10g, Ophiopogon japonicus 10g, Polygonatum odoratum 10g, Phragmites communis rhizome 10g.

[0045] Weigh each ingredient according to the prescribed dosage, add water at a ratio of 1:9 (medicine to water weight), and decoct three times, 45 minutes each time. Combine the decoctions. Concentrate the resulting decoction at 70℃ under a vacuum of -0.02~0.06MPa to form a thick paste. The density of the thick paste at 60℃ is 1.35g / ml. Dry the thick paste at 65℃ under a vacuum of -0.02~0.06MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Coagulate the powder with 30% ethanol to obtain pills. This formula is suitable for deficiency of both Qi and Yin, with concurrent deficiency-heat syndrome; it aims to nourish Yin and clear heat. The combination of the two ingredients enhances the effects of tonifying Qi and nourishing Yin, clearing heat, moistening the lungs, and relieving cough.

[0046] Example 6

[0047] Formula: Ginseng 6g, one navel, Astragalus 10g, Ophiopogon japonicus 15g, Rehmannia glutinosa 8g, Schisandra chinensis 12g, Aster tataricus 10g, Morus alba root bark 15g, Citrus reticulata peel 10g, Glycyrrhiza uralensis 10g, Zingiber officinale 10g, Jujube 15g, Stalactite 12g, Gecko powder 10g.

[0048] The ingredients in the formula are decocted three times with water at a weight ratio of 1:10, each time for 60 minutes, and the decoctions are combined. The resulting decoctions are concentrated into a thick paste at 75℃ under a vacuum of -0.02~0.06MPa. The density of the thick paste at 60℃ is 1.35g / ml. The thick paste is then dried at 72℃ under a vacuum of -0.02~-0.06MPa to obtain a dry paste. The dry paste is pulverized and passed through a 100-mesh sieve to obtain a mixed dry paste powder. 20g of sucrose is added and mixed well. An appropriate amount of 80% ethanol is added, and the mixture is wet-granulated and dried to obtain granules. This formula is suitable for deficiency of both qi and yin, with concurrent deficiency-cold syndrome. It has already achieved the effect of warming and tonifying the lungs and kidneys. The combination of the two enhances the effects of tonifying qi and nourishing yin, warming the lungs and resolving phlegm, and tonifying the kidneys and promoting qi absorption.

[0049] Example 7

[0050] Formula: Ginseng 6g, one navel, Astragalus 10g, Ophiopogon japonicus 15g, Rehmannia glutinosa 9g, Schisandra chinensis 12g, Aster tataricus 10g, Morus alba root bark 10g, Citrus reticulata peel 20g, Glycyrrhiza uralensis 9g, Zingiber officinale 6g, Jujube 10g, Stalactite 10g, Gecko powder 5g.

[0051] Weigh each ingredient according to the prescribed dosage, add water at a ratio of 1:10 (medicine to water) and decoct twice, 60 minutes each time. Combine the decoctions. Concentrate the resulting decoction at 70℃ under a vacuum of -0.02~0.06MPa to form a thick paste. The density of the thick paste at 60℃ is 1.35g / ml. Dry the thick paste at 70℃ under a vacuum of -0.02~0.06MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Make pills with 30% ethanol to obtain pills. This formula is suitable for deficiency of both qi and yin, with concurrent deficiency-cold syndrome. It has already achieved the effect of warming and tonifying the lungs and kidneys. The combination of the two enhances the effects of tonifying qi and nourishing yin, warming the lungs and resolving phlegm, and tonifying the kidneys and receiving qi.

[0052] Example 8

[0053] Formula: Ginseng 9g, 1 piece of ginseng root, Astragalus membranaceus 10g, Ophiopogon japonicus 10g, Rehmannia glutinosa 9g, Schisandra chinensis 10g, Aster tataricus 10g, Morus alba root bark 15g, Citrus reticulata peel 20g, Glycyrrhiza uralensis 12g, 1 centipede, 3 scorpions, Bombyx mori 6g, Pheretima aspergillum 9g.

[0054] The ingredients in the formula are decocted three times with water at a weight ratio of 1:10, each time for 60 minutes, and the decoctions are combined. The resulting decoctions are concentrated into a thick paste at 70℃ and a vacuum degree of -0.02~0.06MPa. The density of the thick paste at 50℃ is 1.20g / ml. The thick paste is dried at 70℃ and a vacuum degree of -0.02~-0.06MPa to obtain a dry paste. The dry paste is pulverized and passed through a 100-mesh sieve to obtain a mixed dry paste powder. 15g of dextrin is added and mixed well. An appropriate amount of 75% ethanol is added, and the mixture is wet-granulated and dried to obtain granules. It is suitable for deficiency of both qi and yin, with concurrent lung meridian obstruction. It has already achieved the effects of promoting blood circulation, removing blood stasis, and unblocking the meridians. The combination of the two enhances the effects of tonifying qi and nourishing yin, promoting blood circulation, removing blood stasis, and clearing the lung meridians.

[0055] Example 9

[0056] Formula: Ginseng 10g, one navel, Astragalus 9g, Ophiopogon japonicus 10g, Rehmannia glutinosa 9g, Schisandra chinensis 10g, Aster tataricus 6g, Morus alba root bark 15g, Citrus reticulata peel 20g, Glycyrrhiza uralensis 9g, one centipede, two scorpions, Bombyx mori 9g, and earthworm 6g.

[0057] Weigh each ingredient according to the prescribed dosage, add water at a ratio of 1:10 (medicine to water) and decoct three times, 60 minutes each time, combining the decoctions. Concentrate the resulting decoction at 70℃ under a vacuum of -0.02~0.06MPa to form a thick paste, with a density of 1.35g / ml at 60℃. Dry the thick paste at 70℃ under a vacuum of -0.02~0.06MPa to form a dry paste. Pulverize the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Make pills with 30% ethanol to obtain pills. This is suitable for deficiency of both Qi and Yin, with concurrent lung meridian obstruction. It has already achieved the effects of promoting blood circulation, removing blood stasis, and unblocking the meridians. The combination of the two enhances the effects of tonifying Qi and nourishing Yin, promoting blood circulation, removing blood stasis, and clearing the lung meridians.

[0058] Clinical Cases

[0059] Mr. Liu, male, 59 years old, presented on September 13, 2023, with a history of "recurrent chest tightness and cough for 6 years, worsening for over a month." Six years prior, he had sought treatment at another hospital for chest tightness and cough, where a chest HRCT scan revealed pulmonary interstitial fibrosis. He had been hospitalized multiple times during this period, receiving symptomatic and supportive treatment including anti-infection, antitussive, and expectorant medications, as well as long-term home oxygen therapy. One month prior to presentation, his chest tightness and cough worsened without any obvious cause. The cough was paroxysmal, mostly dry, occasionally producing small amounts of white frothy sputum, without blood in the sputum. The cough was exacerbated by activity; he would have to stop walking after about 10 meters due to palpitations and shortness of breath, which would subside with rest. He had no significant chills or fever, no joint pain in the limbs, and no obvious cyanosis of the lips. The patient's symptoms did not improve significantly after three days of anti-infection treatment at the local community hospital. The patient presented to our outpatient department today with the following current symptoms: frequent chest tightness and cough, mainly paroxysmal dry cough, occasionally with a small amount of sticky white sputum, no blood in the sputum; feeling weak, no chills or fever, no nasal congestion or runny nose, no cyanosis of the lips; normal bowel movements and urination, poor appetite, poor sleep, and no recent significant weight loss. The tongue is purplish-dark with a thin white coating, and the pulse is deep and weak. The patient has a history of hypertension for over 10 years, regularly taking antihypertensive medication, reporting good blood pressure control, denying other chronic diseases, no history of dust exposure, no history of drug abuse or special medication use, and denies smoking or drinking alcohol. Physical examination: symmetrical chest walls, symmetrically decreased vocal fremitus bilaterally, symmetrical respiratory movements, no pleural friction rub, hyperresonance on percussion of both lungs, Velcro rales bilaterally, prominent in both lower lung fields. Heart rate 116 bpm, regular rhythm, no obvious murmurs heard at any valve. Auxiliary examinations: Blood routine + CRP showed a white blood cell count of 12.4*10. 9 / L, CRP: 18 mg / L, Chest HRCT: Diffuse interstitial changes in both lungs. Pulmonary function tests: Restrictive ventilatory dysfunction, moderate obstructive ventilatory dysfunction.

[0060] Based on the patient's symptoms and tongue and pulse examination, the condition is considered to be Qi and Yin deficiency with lung meridian obstruction. The prescription includes: ginseng 8g, one kidney root, astragalus 10g, ophiopogon 12g, rehmannia 9g, schisandra 15g, aster 6g, mulberry bark 10g, tangerine peel 10g, licorice 10g, one centipede, two scorpions, silkworm 6g, and earthworm 9g. Seven doses, one dose per day, decocted in water and taken warm half an hour after breakfast and dinner. Avoid sour and cold foods, fruits, and fungi.

[0061] Second consultation on September 20th: The patient reported slight improvement in chest tightness and shortness of breath, and could walk 12-15 meters. Coughing and sputum production were also reduced compared to before. Tongue and pulse were basically the same as before. The original prescription was modified by adding 15g of dried tangerine peel, 10g of stir-fried Atractylodes macrocephala, and 15g of Poria cocos, for 14 doses. The patient was instructed to practice pursed-lip breathing to increase the pressure in the small airways, shifting the isobaric point towards the large airways, preventing premature collapse and closure of the small airways, facilitating the expulsion of residual air from the alveoli, and improving gas exchange. Home oxygen therapy was continued.

[0062] Third consultation on October 4: After taking 14 doses of the medicine, the patient reported that the symptoms of cough and fatigue were relieved, the chest tightness and shortness of breath after activity were better than before, and the expectoration was significantly relieved.

[0063] Note: The patient in this case was diagnosed with pulmonary fibrosis by Western medicine and pulmonary atrophy by Traditional Chinese Medicine. The patient had experienced recurrent chest tightness and cough for several years, primarily paroxysmal dry cough with occasional small amounts of sticky white sputum, which worsened after exertion. The bilateral chest walls were symmetrical, with symmetrically diminished vocal fremitus and symmetrical respiratory movements. There was no pleural friction rub. Percussion revealed hyperresonance in both lungs, and Velcro rales were present bilaterally, particularly in the lower lobes. The heart rate was 116 bpm, regular, with no obvious murmurs heard at any valve. Chest HRCT showed diffuse interstitial changes in both lungs. The tongue was purplish-dark with a thin white coating, and the pulse was deep and weak. Therefore, the diagnosis was Qi and Yin deficiency syndrome, complicated by lung meridian obstruction. Due to the patient's long-term recurrent cough, lung Qi was deficient, leading to Qi deficiency and blood stasis, resulting in blood stasis obstructing the lung meridians. The treatment principle is to use ginseng, umbilicus, and astragalus to replenish lung qi and the qi of the whole body; ophiopogon to nourish yin; centipede, scorpion, silkworm, and earthworm to invigorate blood and remove blood stasis; rehmannia to nourish kidney yin; schisandra to astringe yin; tangerine peel, dried tangerine peel, atractylodes macrocephala, and poria to regulate qi and strengthen the spleen to help the qi flow smoothly; mulberry bark and aster to stop cough and resolve phlegm; and to combine traditional Chinese medicine guiding techniques to help recovery.

[0064] The clinical efficacy trials of the present invention are described in detail below:

[0065] 1. Materials and Methods

[0066] 1.1 Source of Cases

[0067] Sixty patients who met the diagnostic criteria for Qi and Yin deficiency type pulmonary atrophy and were hospitalized in the Department of Respiratory Medicine at the Affiliated Suzhou Traditional Chinese Medicine Hospital of Nanjing University of Traditional Chinese Medicine from September 2022 to September 2023 were selected as the study subjects. Considering a dropout rate of no more than 20%, the total number of cases was set at 70. A total of 61 patients completed the 3-month follow-up, and 50 patients completed the 6-month follow-up. Five patients dropped out, including 3 who could not continue to seek medical treatment (including difficulties in long-distance travel, difficulty in preparing the medicine, and intolerance to the side effects of pirfenidone), 1 who dropped out due to economic reasons, and 1 who dropped out due to lung transplantation surgery; 3 patients were excluded, all of whom had no records; 1 patient experienced diarrhea and discomfort after taking traditional Chinese medicine and terminated the experiment, resulting in 61 valid cases participating in the study.

[0068] 1.2 Inclusion Criteria

[0069] (1) Meets both the Western and Traditional Chinese Medicine diagnostic criteria for pulmonary fibrosis;

[0070] (2) Age between 40 and 85 years old, with no gender restriction;

[0071] (3) Signed an informed consent form and did not participate in other clinical studies.

[0072] 1.2.1 Western Medicine Diagnostic Criteria

[0073] The diagnosis of pulmonary fibrosis mainly relies on a comprehensive analysis of chest HRCT and pulmonary function tests, as well as bronchoscopy or lung biopsy when necessary. Chest HRCT shows honeycomb lung or reticular shadows, with or without traction bronchiectasis. Combined with medical history, symptoms, and physical examination, a clinical diagnosis of pulmonary fibrosis can be made. Patients with pulmonary fibrosis include those with IPF (intrapulmonary fibrosis) and those with pulmonary fibrosis secondary to connective tissue diseases, autoimmune diseases, occupational or other environmental exposures, and toxic drug damage.

[0074] The diagnostic criteria for IPF are based on the 2022 International Clinical Practice Guidelines for Adult IPF:

[0075] (1) Excluding other known causes of ILD (e.g., environmental exposure such as home and occupation, connective tissue diseases and toxic drugs), plus clause 2 or 3;

[0076] (2) Patients whose HRCT findings are UIP type;

[0077] (3) Patients who have undergone surgical lung biopsy are diagnosed based on a specific combination of HRCT and surgical lung biopsy.

[0078] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0079] The diagnostic criteria for idiopathic pulmonary fibrosis in traditional Chinese medicine were formulated with reference to the "Standardized Diagnosis and Treatment of Internal Medicine Diseases in Traditional Chinese Medicine".

[0080] Diagnostic criteria for Qi and Yin deficiency syndrome in idiopathic pulmonary fibrosis: Qi and Yin deficiency syndrome was defined with reference to the "Standardized Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine" and "Internal Medicine in Traditional Chinese Medicine".

[0081] Main symptoms: (1) dry cough with little phlegm; (2) wheezing, which worsens after activity and is progressive.

[0082] Secondary symptoms: (1) weak cough; (2) fatigue, shortness of breath and weakness; (3) spontaneous sweating and aversion to wind; (4) dry mouth and thirst; (5) night sweats.

[0083] Tongue and pulse: The tongue is tender and red with little or no coating, and the pulse is weak and rapid or thin and feeble.

[0084] A diagnosis can be made based on two main symptoms plus one secondary symptom, or one main symptom plus two secondary symptoms.

[0085] 1.3 Exclusion Criteria

[0086] (1) Patients in the acute phase, or patients with severe lung infections or other acute and critical illnesses;

[0087] (2) Those who have already participated in other clinical trials;

[0088] (3) Those who are intolerant to or allergic to the treatment regimen in this study;

[0089] (5) Those with serious, life-threatening diseases of the heart, brain, liver, kidneys, or other systems, or those suffering from mental illness;

[0090] (5) Women who are preparing for pregnancy, pregnant women, and breastfeeding women;

[0091] (6) Patients who have taken glucocorticoids within one month prior to enrollment (e.g., prednisone exceeding 10 mg / day, or dexamethasone exceeding the equivalent dose); patients who have used immunosuppressants within one month prior to enrollment; patients who have used pirfenidone, nintedanib, or antacids within one month prior to enrollment.

[0092] 1.4 Exclusion Criteria

[0093] (1) Cases for which no records were kept after the trial was conducted;

[0094] (2) Those who did not use the medication properly during the experiment.

[0095] 1.5 Termination of Test Criteria

[0096] (1) If any intolerable adverse events occur, the study should be stopped;

[0097] (2) If, according to the doctor's judgment, the patient's condition worsens or other conditions affect the observation of the trial, the clinical trial should be stopped (and the patient should be treated as an invalid case).

[0098] (3) If, as determined by a doctor, there are serious deviations in the implementation of the clinical trial protocol, it is difficult to evaluate the drug effect, such as poor compliance.

[0099] (4) Subjects who do not wish to continue treatment and request to withdraw.

[0100] 1.6 Dropout criteria and management of dropout cases

[0101] (1) Criteria for dropout: Subjects who have been screened and entered the trial but whose treatment course and observation period do not meet the criteria of the study protocol for any reason are judged as dropout cases.

[0102] (2) Handling of dropout cases: a. When a subject drops out, the researcher should contact the subject as soon as possible to inquire about the reason and take appropriate measures, and continue to record the last medication time and observable indicators. b. Previous trial data of dropout cases should be kept on file.

[0103] 1.7 Research Methods

[0104] 1.7.1 Random Grouping

[0105] The 70 patients were assigned pre-numbered A1-A according to their admission time. 70 Read a 3-digit number from any row and any column of a simple random number table as the starting number of the random number record, and continuously generate 70 random number records B1-B2. 70 A1 corresponds to B1, A2 corresponds to B2, and so on. Then, record all the random numbers (B1-B2). 70 Number them from smallest to largest (C1-C) 70 (Random numbers with the same value are numbered according to the order of entry time), with serial numbers C1~C1. 35 As the control group, serial number C 36 ~C 70 The control group consisted of 36 patients and the treatment group consisted of 34 patients at enrollment; ultimately, 61 valid cases were included, of which 32 were in the control group and 29 were in the treatment group.

[0106] 1.7.2 Treatment Plan

[0107] Basic treatment: Provide good patient education, pay attention to protection from wind and cold, keep warm, avoid contact with irritating odors, particulate dust and chemical reagents, and adjust daily routines and diet.

[0108] Control group: In addition to basic treatment, patients received oral pirfenidone (Aisiri 100mg*54 tablets, manufactured by Beijing Kangtini Pharmaceutical Co., Ltd., batch number: National Drug Approval Number H20133376). Dosage: One tablet three times daily during the first week; two tablets three times daily during the second week; three tablets three times daily during the third week, and so on until the sixth week, with a daily dose of 1800mg. Closely monitor patient tolerance. If gastrointestinal symptoms occur, or if skin allergies to sunlight or ultraviolet radiation develop, or if liver or kidney function is impaired, reduce the dosage appropriately or discontinue use.

[0109] Treatment group: In addition to basic treatment, the following herbs were administered: ginseng 6g, one piece of *Kanqi* (a type of medicinal herb), astragalus 10g, *Ophiopogon japonicus* 12g, *Rehmannia glutinosa* 10g, *Schisandra chinensis* 10g, aster 6g, mulberry bark 15g, tangerine peel 15g, and licorice root 10g. Other herbs were added or subtracted as needed based on symptoms. The herbal decoction pieces were sourced from the pharmacy of Suzhou Municipal Hospital of Traditional Chinese Medicine. The herbs were decocted in 600ml of water for 30 minutes. One dose was administered daily, 150ml twice daily. One course of treatment lasted 3 months, with two consecutive courses administered. If acute exacerbations occurred during treatment, immediate symptomatic treatment was necessary. If medication was discontinued for no more than two weeks, the trial could continue.

[0110] Comorbid treatment: The names of medications that must be continued for comorbid diseases, dosages, and frequency of use must be recorded in the study medical records for analysis and reporting during the summary.

[0111] 1.7.3 Observation Indicators

[0112] 1.7.3.1 Traditional Chinese Medicine Symptom Scoring

[0113] Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" issued by the State Administration of Traditional Chinese Medicine, a TCM symptom scoring table was completed before treatment, 3 months after treatment, and 6 months after treatment. (See Table 1)

[0114] Table 1. Traditional Chinese Medicine Clinical Symptom Scoring Table

[0115]

[0116] Note: The scoring method is based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the State Administration of Traditional Chinese Medicine. Scoring principle: The main symptoms are scored as "mild, moderate, and severe", and are rated as "3 points, 6 points, and 9 points" respectively; the secondary symptoms are scored as "mild, moderate, and severe", and are rated as "2 points, 4 points, and 6 points" respectively.

[0117] 1.7.3.2 St. George's Respiratory Questionnaire (SGRQ) scoring

[0118] The SGRQ was assessed before treatment, 3 months after treatment, and 6 months after treatment, using the version revised by Professor Cai Baiqiang. The SGRQ is mainly used to evaluate the impact of chronic airway diseases on patients' quality of life. Many studies at home and abroad have also used the SGRQ to evaluate the quality of life of patients with pulmonary fibrosis. The questionnaire includes three parts: symptoms, activity level, and disease impact.

[0119] 1.7.3.3 Pulmonary function test

[0120] Lung function tests (including at least FEV1, FVC, and DLCOSB) were performed before treatment, at 3 months, and at 6 months after treatment.

[0121] 1.7.3.4 6-minute walk (6MWD)

[0122] Observe the changes in the patient's 6-minute walking distance before treatment, 3 months after treatment, and 6 months after treatment.

[0123] 1.7.3.5 SpO2% Determination

[0124] Observe the changes in SpO2% of patients before treatment, 3 months after treatment, and 6 months after treatment.

[0125] 1.7.3.6 Number of acute exacerbations

[0126] Observe the number of times the patient experiences acute exacerbations during treatment.

[0127] 1.7.3.7 Safety Observation

[0128] Observe blood routine tests and liver and kidney function before treatment and at 3 and 6 months of treatment. Also, record the occurrence of adverse events accurately.

[0129] 1.7.4 Evaluation Time Point

[0130] Table 2. Trial Follow-up Form

[0131]

[0132] 2. Statistical Analysis

[0133] This study used SPSS 20 statistical software for data analysis, and all statistical tests were two-tailed. p A value <0.05 was considered statistically significant. Quantitative data were described statistically as mean ± standard deviation (Mean ± SD). For normally distributed quantitative data, t-tests were used; independent samples t-tests were used for between-group comparisons, and paired t-tests were used for within-group comparisons. For non-normally distributed quantitative data, nonparametric tests (rank-sum tests) were used. Chi-square tests were used for categorical data; and rank-sum tests were used for ordinal data.

[0134] 3. Results

[0135] 3.1 Baseline Data

[0136] A total of 70 patients with pulmonary fibrosis were included. The gender, age, disease duration, and smoking status of the newly enrolled patients were statistically analyzed. Statistical analysis revealed no statistically significant differences in baseline data between the two groups (see Tables 3, 4, and 5), demonstrating the feasibility and scientific validity of the study.

[0137] Table 3. Gender distribution of the two groups

[0138]

[0139] Table 4. Age and average disease duration of the two groups

[0140]

[0141] Table 5 Smoking status of the two groups of patients

[0142]

[0143] 3.2 Traditional Chinese Medicine Symptom Scoring and SGRQ

[0144] This study included 61 patients. The TCM symptom scores and SGRQ (St. George's Respiratory Questionnaire) data conformed to a normal distribution. Paired t-tests were used for pre- and post-treatment comparisons, and unpaired t-tests were used for inter-group comparisons. Differences between 3 months and 6 months and pre-treatment levels, as well as differences between the treatment group and the control group, were statistically analyzed. Results showed that both scores significantly improved compared to pre-treatment levels, with the treatment group showing better results than the control group. Specific results are shown in Table 6.

[0145] Table 6 Comparison of TCM symptom scores and SGRQ before and after treatment

[0146]

[0147] Note: Compared with before treatment,* p <0.05,** p <0.01, “ns” indicates no statistical difference; compared with the control group, # p <0.05, "NS" indicates no statistically significant difference.

[0148] 3.3 Lung function

[0149] A total of 61 cases were included. Results showed that before treatment and at 3 and 6 months after treatment, the lung function (FEV1, FVC, DLCO SB) data in both groups conformed to a normal distribution. Paired t-tests were used before and after treatment, and unpaired t-tests were used for inter-group comparisons. Results showed that at 3 months after treatment, there were no statistically significant differences in lung function (FEV1, FVC, DLCO SB) compared to before treatment, indicating that treatment could inhibit further deterioration of lung function and delay the progression of pulmonary fibrosis. At 6 months after treatment, some lung function indicators (FEV1, FVC, DLCO SB) showed significant differences compared to before treatment, and the treatment group was superior to the control group (see Table 7 for details).

[0150] Table 7 Comparison of lung function before and after treatment

[0151]

[0152] Note: Compared with before treatment,* p <0.05,** p <0.01, “ns” indicates no statistical difference; compared with the control group, # p <0.05, "NS" indicates no statistically significant difference.

[0153] 3.4 SpO2% and 6MWD

[0154] A total of 61 cases were included. Data from both the treatment and control groups followed a normal distribution. Paired t-tests were used before and after treatment, and unpaired t-tests were used for inter-group comparisons. Results showed that after 3 and 6 months of treatment, the 6-minute walking distance increased in both groups compared to before treatment, with statistically significant differences. The treatment group showed greater improvement than the control group. Transcutaneous SpO2% increased after 3 and 6 months of treatment compared to before treatment, although there was no statistically significant difference between groups, but the treatment group showed a trend of increasing SpO2% compared to the control group (see Table 8). These results indicate that this traditional Chinese medicine composition can significantly improve the walking test in patients with pulmonary fibrosis, with a trend of increasing SpO2%. It is estimated that a prolonged treatment period may lead to a significant difference, and further in-depth analysis of this indicator will be conducted in future studies.

[0155] Table 8 Comparison of 6MWD and SpO2% before and after treatment

[0156]

[0157] Note: Compared with before treatment,* p <0.05,** p <0.01, “ns” indicates no statistical difference; compared with the control group, # p <0.05, "NS" indicates no statistically significant difference.

[0158] 3.5 Number of acute exacerbations

[0159] During the 6-month treatment period, none of the patients experienced acute exacerbations.

[0160] 3.6 Adverse reaction observation

[0161] During the follow-up period of this study, no patients experienced liver or kidney dysfunction or palpitations. Adverse events included: in the control group, one patient developed oral ulcers, one patient developed gastroesophageal reflux, and two patients developed diarrhea; all adverse events were improved in the treatment group compared to the control group. This traditional Chinese medicine composition can improve patients' gastrointestinal reactions and enhance their tolerance compared to the control group (see Table 9).

[0162] Table 9 Safety observations and adverse reactions

[0163]

[0164] 4 Results Analysis

[0165] This study investigated the differences in clinical efficacy between the control and treatment groups from several aspects, including baseline data, TCM symptom scores and the SGRQ (Spiritual Respiratory Questionnaire), pulmonary function, SpO2% and 6MWD (spO2% and 6MWD), number of acute exacerbations, and adverse reactions. Baseline data included indicators such as gender, age, disease duration, and smoking status; maintaining no differences in baseline data between groups was fundamental and a prerequisite for subsequent related research. The TCM symptom score is a rating scale that scores symptoms and signs of the disease according to certain weights and standards, used for clinical diagnosis and assessment. This scale has been used in several domestic hospitals and has certain research and application value internationally, ensuring the scientific rigor of this study. The SGRQ is one of the most widely used scales for measuring respiratory system impairment and quality of life. It can be divided into three main aspects: symptoms (frequency and severity of symptoms), activity (activity that causes shortness of breath or activity restriction caused by shortness of breath), and impact on daily activities (social impairment and psychological distress caused by airway disease). These three main aspects are scored according to the weight of different questions, and the scores are finally summed to obtain a total score. The higher the patient's score, the worse their quality of life. This study compared the TCM symptom scores and SGRQ scores of the two groups. While both groups showed significant improvement after 6 months, the treatment group showed a more significant improvement than the control group. Furthermore, the treatment group already exhibited a significant difference at the 3-month time point, suggesting that the TCM composition of this invention does indeed have an improving effect on pulmonary fibrosis. Lung function, SpO2%, and 6MWD are commonly used clinical evaluation indicators for pulmonary fibrosis, fully reflecting the differences between the two groups in oxygen utilization efficiency, hypoxia tolerance, and NO diffusion. These results clearly indicate that the TCM composition of this invention can improve patients' lung function and exercise tolerance. Adverse reactions in both groups were relieved without special treatment, indicating that both treatment regimens have high safety characteristics. The improved adverse reactions in the treatment group compared to the control group further confirm the safety of the TCM composition of this invention in widespread clinical application.

Claims

1. A traditional Chinese medicine composition for treating lung flaccidity of qi-yin deficiency, characterized in that, The traditional Chinese medicine composition is prepared from ginseng 6-10 g, can 1, astragalus 8-15 g, ophiopogon 10-15 g, prepared rehmannia 8-15 g, schisandra 10-15 g, purple yam 6-10 g, white mulberry bark 10-15 g, dried tangerine or orange peel 10-20 g, and licorice 9-12 g by weight.

2. The traditional Chinese medicine composition for treating lung flaccidity of qi-yin deficiency according to claim 1, characterized in that, The traditional Chinese medicine composition is added with sandwort 6-10 g, bamboo shoot 5-10 g, polygonatum 6-10 g, and reed root 10-15 g, and is suitable for treating qi-yin deficiency with deficiency heat syndrome.

3. The traditional Chinese medicine composition for treating lung flaccidity of qi-yin deficiency according to claim 1, characterized in that, The traditional Chinese medicine composition is added with dried ginger 6-10 g, jujube 8-15 g, stalactite 10-15 g, and haliotis powder 5-10 g, and is suitable for treating qi-yin deficiency with deficiency cold syndrome.

4. The traditional Chinese medicine composition for treating lung flaccidity of qi-yin deficiency according to claim 1, characterized in that, The traditional Chinese medicine composition is added with centipede 1-2, scorpion 2-4, silkworm chrysalis 6-10 g, and earthworm 6-10 g, and is suitable for treating qi-yin deficiency with lung collateral blockage syndrome.

5. A pharmaceutical preparation of the traditional Chinese medicine composition for treating lung flaccidity of deficiency of both qi and yin according to any one of claims 1 to 4, characterized in that, The traditional Chinese medicine composition is prepared into any one of a decoction, a granule, a pill, a tablet, a capsule, a plaster, a syrup, and a powder by adding a medically acceptable excipient.

6. The pharmaceutical preparation of the traditional Chinese medicine composition for treating lung flaccidity of qi-yin deficiency according to claim 5, characterized in that, The granule is prepared by the following steps: (1) decocting: each medicine in the formula is weighed according to the formula amount, and water is added at a ratio of 1:6-8 by weight to decoct 1-3 times, each time for 30-60 min, and the decocting liquid is combined; (2) concentrating: the obtained decocting liquid is concentrated into thick paste at 50-75 ℃ and a vacuum degree of -0.02-0.06 MPa, and the thick paste has a density of 1.20 g / mL at 50 ℃; (3) drying: the thick paste is dried into dry paste at 60-70 ℃ and a vacuum degree of -0.02-0.06 MPa, and the dry paste is reserved; (4) the dry paste is crushed and passed through a 100-mesh sieve to obtain mixed dry paste powder, 10-30 g of granulation excipient is added and uniformly mixed, and an appropriate amount of 70%-90% ethanol is added to wet-granulate, and the granule is obtained after drying.

7. The pharmaceutical preparation of the traditional Chinese medicine composition for treating lung flaccidity of qi-yin deficiency according to claim 6, characterized in that, The granulation excipient is one or a combination of more than one of dextrin, malt dextrin, or sucrose. The pill is prepared by the following steps:

8. The pharmaceutical preparation of the traditional Chinese medicine composition for treating Qi-Yin deficiency type of lung flaccidity according to claim 5, characterized in that, (1) decocting: each medicine in the formula is weighed according to the formula amount, and water is added at a ratio of 1:6-10 by weight to decoct 1-3 times, each time for 35-45 min, and the decocting liquid is combined; (2) concentrating: the obtained decocting liquid is concentrated into thick paste at 50-75 ℃ and a vacuum degree of -0.02-0.06 MPa, and the thick paste has a density of 1.20-1.35 g / mL at 50-60 ℃; (3) drying: the thick paste is dried into dry paste at 50-75 ℃ and a vacuum degree of -0.02-0.06 MPa, and the dry paste is reserved; (4) the dry paste is crushed and passed through a 100-mesh sieve to obtain mixed dry paste powder, and the powder is panned with water or a 30% or less concentration of ethanol aqueous solution to obtain the pill.

9. Use of the traditional Chinese medicine composition of any one of claims 1-4 in the preparation of a drug for treating qi-yin deficiency type lung atrophy. ​

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