Traditional Chinese medicine composition for treating chronic cough caused by phlegm-dampness obstructing lung and wind disturbing reversed flow of qi as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic cough caused by phlegm-dampness obstructing lung and wind-disturbing reversed-qi flow as well as a preparation method and application of the traditional Chinese medicine composition, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 to 18 parts of radix bupleuri, 7 to 14 parts of radix scutellariae, 10 to 18 parts of rhizoma pinelliae, 10 to 14 parts of cortex magnoliae officinalis, 8 to 12 parts of semen armeniacae amarae, 7 to 12 parts of lumbricus, 10 to 15 parts of poria cocos, 6 to 12 parts of fructus perillae, 6 to 12 parts of radix platycodonis and 8 to 12 parts of radix angelicae sinensis. The radix bupleuri and the pinellia ternate are used as monarch drugs for treating core pathogenesis, the ministerial drugs are used for assisting and synergism, the adjuvant drugs are used for comprehensively complementing the pathogenesis and performing targeted conditioning, so that the drugs are used for guiding channels and regulating the middle warmer, strengthening the body resistance and harmonizing and progressively increasing layer by layer, the symptoms such as cough, asthma and excessive phlegm are quickly relieved, and the effects of reducing phlegm, clearing damp, regulating qi activity, fixing and protecting lung and spleen and completely eradicating relapse are achieved. The traditional Chinese medicine composition accords with the principle that the symptoms are treated when urgent treatment is carried out and the root is treated when slow treatment is carried out, and a unique treatment scheme is formed.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi reversal type, as well as its preparation method and application. Background Technology

[0002] Chronic cough is a common respiratory symptom in clinical practice, with an incidence rate as high as 10%. It has a prolonged course and complex pathogenesis. Western medicine believes that the occurrence of chronic cough is mostly related to chronic airway inflammation, with the activation of various inflammatory cells such as eosinophils. Traditional Chinese medicine classifies chronic cough into the categories of "prolonged cough" and "stubborn cough," believing that its pathogenesis is diverse. Among them, "phlegm-dampness obstructing the lungs and wind disturbing the upward flow of qi" is a core and common syndrome. The essence of this syndrome lies in the spleen's failure to transport and transform qi, resulting in the internal generation of phlegm-dampness, which disturbs the lungs, causing lung qi to be congested and its function of dispersing and descending qi to be impaired. At the same time, the liver fails to disperse and drain qi, and the Shaoyang pivot is not in harmony. The qi stagnation obstructs the lung qi's intake and output, generating heat and wind, which helps phlegm-dampness to accumulate, forming "phlegm stagnation." The internal dysfunction of the pivot and the stagnation of phlegm-dampness easily attract external wind or internal liver wind. The wind and phlegm fight each other, disturbing the pivot of lung qi's dispersing and descending qi, leading to lung qi rising upward and persistent cough. Clinical manifestations include recurrent cough, copious and sticky or frothy sputum, rattling in the throat, coughing upon itching of the throat, chest tightness, shortness of breath, epigastric fullness, greasy tongue coating, and wiry and slippery pulse.

[0003] Modern Western medicine treatment for chronic cough often involves inhaled low-dose corticosteroids combined with bronchodilators (β2-receptor agonists or aminophylline, etc.), or combination preparations of both such as budesonide / formoterol or fluticasone / salmeterol. Short-term oral low-dose corticosteroid therapy may be used if necessary. Treatment duration should be no less than 8 weeks. While it can control symptoms in the short term, it has significant limitations: symptoms are prone to recurrence after discontinuation, requiring long-term management; individual drug responses vary greatly, with some patients experiencing allergies or poor efficacy; long-term use of Western medicine and hormone therapy can induce side effects such as oral candidiasis and hoarseness.

[0004] Modern medicine believes that chronic cough is often related to allergic factors. Traditional Chinese medicine (TCM) clinical practice should therefore add herbs with anti-allergic effects, such as Xu Changqing (Radix Cynanchi Atrati), Jingjie (Radix Schizonepetae), Chanyi (Semen Cicadae Periostracum), Dilong (Radix Pheretimae), Huangqin (Radix Scutellariae), Jiangcan (Radix Bombyx Batryticatus), and Fangfeng (Radix Saposhnikoviae). Currently, there are numerous TCM formulas for treating chronic cough, such as Er Chen Tang (Decoction of Two Ingredients), Zhisou San (Sophora Seed Powder for Cough Relief), Sangju Yin (Mulberry Leaf and Chrysanthemum Decoction), Xiao Qinglong Tang (Minor Blue Dragon Decoction), and Wuling San (Five-Ingredient Powder with Poria), with modifications, reflecting the diversity and flexibility of TCM's syndrome differentiation and treatment. However, when dealing with chronic cough with complex etiologies and mechanisms and a protracted course, the clinical application of these formulas still generally faces the following problems: (1) The accuracy of the formula correspondence needs to be improved: Some formulas are good at warming and resolving cold phlegm and strengthening the spleen and drying dampness (such as Er Chen Tang), but for the pathogenesis of wind-evil disturbance and qi stagnation, their ability to dispel wind and relieve spasm and harmonize the liver and lungs is often insufficient, resulting in unsatisfactory control of the sudden onset, paroxysmal and emotionally related symptoms of cough in some patients; Some formulas focus on dispelling wind, ventilating the lungs and stopping cough (such as Zhisou San), but for those with phlegm and dampness accumulation or qi deficiency, the effects of resolving phlegm and reversing adverse flow and strengthening the body are relatively weak, making it difficult to block the source of phlegm and dampness or prevent the cough from being prolonged and recurring; Other formulas are good at relieving exterior cold and warming the lungs and resolving phlegm (such as Xiao Qinglong Tang), but if the patient has heat stagnation or yin deficiency, it is easy to cause the drawback of warming and drying, damaging body fluids and promoting heat.

[0005] (2) Insufficient modern scientific support for efficacy evaluation: The efficacy of many empirical formulas, hospital preparations, or commonly used clinical formulas for treating chronic cough is mostly based on the personal experience of physicians or small-scale case observations, lacking large-sample clinical trials that follow modern evidence-based medicine principles and are rigorously designed (such as randomized, double-blind, placebo-controlled, and multicenter). Symptom scores are mostly subjective descriptions, and objective evaluation indicators (such as cough frequency monitoring, airway sensitivity measurement, inflammatory markers, etc.) are rarely used, resulting in a low degree of quantification and acceptance of efficacy evidence, which restricts its widespread recognition and application both domestically and internationally.

[0006] (3) The modernization of classic prescriptions is lagging behind: Although many classic prescriptions (such as Banxia Houpu Decoction and Xiaochaihu Decoction) are exquisitely formulated and rigorously based on theory, there is still a lack of systematic, in-depth and reproducible high-quality research on their precise indications, optimal dosage range, clear dose-effect relationship and specific mechanism of action elucidated by modern pharmacology and molecular biology for the treatment of "chronic cough" as a specific modern disease category. As a result, their valuable clinical value has been buried and they have failed to be effectively transformed into new Chinese medicines that meet the needs of modern clinical practice.

[0007] In conclusion, there is an urgent clinical need for a safe and effective traditional Chinese medicine compound treatment plan that, while inheriting the essence of TCM syndrome differentiation and treatment, can more accurately address the complex core pathogenesis of chronic cough (phlegm-dampness obstructing the lungs and wind-disturbing qi), and is supported by sufficient modern clinical research data and scientific evidence. Summary of the Invention

[0008] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for treating chronic cough due to phlegm-dampness obstructing the lungs and wind-disturbed qi, along with its preparation method and application. The primary objective is to provide a scientifically formulated, holistic, effective, and safe traditional Chinese medicine composition. This composition is designed based on the unified treatment principle of "regulating the body's mechanisms to extinguish wind, drying dampness and resolving phlegm to clear the lungs, and unblocking the channels and strengthening the body's resistance to treat chronic illness." It includes a basic formula and two optimized formulas formed by adding or subtracting ingredients from the basic formula to address different concurrent symptoms. Another objective of this invention is to provide the preferred ratio range and best embodiments of the traditional Chinese medicine composition. A further objective is to provide a preparation method for this traditional Chinese medicine composition and its application in preparing medications for treating chronic cough due to phlegm-dampness obstructing the lungs and wind-disturbed qi, and to demonstrate its significant efficacy using rigorous retrospective clinical data.

[0009] In order to achieve the objective of this invention, the following solution is proposed: A traditional Chinese medicine composition for treating chronic cough due to phlegm-dampness obstructing the lungs and wind-disturbed qi, comprising the following raw materials in parts by weight: Bupleurum chinense 10-18 parts, Scutellaria baicalensis 7-14 parts, Pinellia ternata 10-18 parts, Magnolia officinalis 10-14 parts, Prunus armeniaca 8-12 parts, Pheretima aspergillum 7-12 parts, Poria cocos 10-15 parts, Perilla frutescens 6-12 parts, Platycodon grandiflorus 6-12 parts, and Angelica sinensis 8-12 parts; wherein Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

[0010] As one preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Bupleurum chinense 10-18 parts, Scutellaria baicalensis 7-14 parts, Pinellia ternata 10-18 parts, Magnolia officinalis 10-14 parts, Prunus armeniaca 8-12 parts, Pheretima aspergillum 7-12 parts, Poria cocos 10-15 parts, Perilla frutescens 6-12 parts, Platycodon grandiflorus 6-12 parts, Angelica sinensis 8-12 parts, Bombyx mori 6-12 parts, and Taraxacum mongolicum 10-20 parts; wherein Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

[0011] As another preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Bupleurum chinense 10-18 parts, Scutellaria baicalensis 7-14 parts, Pinellia ternata 10-18 parts, Magnolia officinalis 10-14 parts, Prunus armeniaca 8-12 parts, Pheretima aspergillum 7-12 parts, Poria cocos 10-15 parts, Perilla frutescens 6-12 parts, Platycodon grandiflorus 6-12 parts, Angelica sinensis 8-12 parts, Bombyx mori 6-12 parts, Taraxacum mongolicum 10-20 parts, Zingiber officinale 3-5 parts, and Schisandra chinensis 5-8 parts; wherein Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

[0012] Specifically, the type of Bupleurum mentioned is: Bupleurum chinense DC, a plant of the Apiaceae family. Remove impurities and residual stems, wash, soak thoroughly, cut into thick slices, and dry.

[0013] Specifically, the Scutellaria type mentioned is the dried root of Scutellaria baicalensis Georgi, a plant belonging to the Lamiaceae family. Preparation: Remove impurities, boil in boiling water for 10 minutes or steam for 30 minutes, remove, slice thinly, and dry.

[0014] Specifically, the type of Magnolia officinalis mentioned refers to the dried bark, root bark, and branch bark of Magnolia officinalis Rehd. etWils., a plant belonging to the Magnoliaceae family. Preparation: Scrape off the outer bark, wash, moisten thoroughly, shred, and dry.

[0015] Specifically, the type of Pinellia is: the dried tuber of Pinellia ternata (Thunb.) Breit., a plant of the Araceae family; this product is a toxic traditional Chinese medicine, and is generally used in medicine as a processed product, which requires the removal of impurities during purification.

[0016] Specifically, the earthworm type is: Pheretima aspergillum (E. Perrier), a species of worm family, after removing impurities, washing, cutting into sections, and drying.

[0017] Specifically, the almond type is: dried, mature seeds of Prunus armeniaca L., with impurities and residual hard shells removed (crushed before use).

[0018] Specifically, the type of Poria cocos is: the dried sclerotium of the fungus Poria cocos (Schw.) Wolf of the Polyporaceae family. Take one Poria cocos, soak it, wash it, moisten it and steam it slightly, peel off the outer skin in time, cut it into pieces or thick slices, and dry it.

[0019] Specifically, the perilla seed type is: the dried, mature fruit of Perilla frutescens (L.) Britt., a plant of the Lamiaceae family, after removing impurities, washing, and drying (crushing before use).

[0020] Specifically, the type of Platycodon is: the dried root of Platycodon grandiflorum (Jacq.) A. DC., a plant of the Campanulaceae family, after removing impurities, washing, soaking thoroughly, cutting into thick slices, and drying.

[0021] Specifically, the dried ginger is: the dried rhizome of Zingiber officinale Rosc. (a plant in the ginger family), after removing impurities, soaking briefly, washing, moistening thoroughly, cutting into thick slices or chunks, and drying.

[0022] Specifically, the type of Schisandra chinensis is: the dried, mature fruit of Schisandra chinensis (Turcz.) Baill., a plant of the Magnoliaceae family, after removing the fruit stalks and impurities.

[0023] Specifically, the Angelica type is: the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family, after removing impurities, washing, soaking thoroughly, slicing thinly, and drying.

[0024] Specifically, the type of silkworm that is killed is the dried body of the 4th to 5th instar larvae of the silkworm (Bombyx mori Linnaeus) infected (or artificially inoculated) with Beauveria bassiana (Bals.) Vuillant, after removing impurities and residual silk, washing, and drying.

[0025] Specifically, the dandelion type is: the dried whole herb of Taraxacum mongolicum Hand.-Mazz., a plant of the Asteraceae family, after removing impurities, washing, cutting into sections, and drying.

[0026] Explanation of the principles of prescription formulation and traditional Chinese medicine theory: The formulation of this invention is not a simple accumulation of drugs, but rather an organic whole formed based on a profound understanding of the pathogenesis of "chronic cough due to phlegm-dampness obstructing the lungs and wind disturbing the qi," strictly adhering to the traditional Chinese medicine theory of "principal, assistant, adjuvant, and guide" drug pairing. The entire formula is based on "regulating the pivot to extinguish wind, drying dampness and resolving phlegm to clear the lungs, and unblocking the channels and supporting the body's resistance to treat chronic diseases." Its formulation logic is explained as follows: The principal herbs (Bupleurum and Pinellia) resolve phlegm and relieve nausea, dispel wind and promote lung function, regulate the body's functions, guide the course of the disease, and target the core pathogenesis.

[0027] Bupleurum: Bitter and pungent in taste, slightly cold in nature, it enters the liver, gallbladder, and lung meridians. It is the chief herb of the classic formula Xiao Chai Hu Tang, and here it is also the chief herb, which can "soothe the liver to benefit the lungs, regulate the pivot to harmonize the interior, and promote the flow of qi to the exterior." Its mechanism of action is as follows: First, it can soothe the liver and relieve depression, and regulate the flow of qi. Professor Wu Weiping said, "If the liver qi is not smooth, the pivot will not be smooth, and the lung qi will be obstructed." Bupleurum enters the liver meridian, which can regulate the flow of qi and restore the liver's function of dispersing and draining, thereby relieving the stagnation of qi in the lungs. Second, it can harmonize the pivot and expel pathogens. Bupleurum can enter the Shaoyang meridian, soothe the triple burner, and unblock the flow of qi, blood, and body fluids, so that internal phlegm and dampness can be resolved, and external wind can also be expelled and expelled. Third, it can promote the flow of qi in the lungs and expel pathogens, and extinguish internal wind. Its nature is ascending and dispersing, which guides qi upward, helps the lung qi to spread, and at the same time soothes the liver to extinguish internal wind.

[0028] Pinellia ternata: pungent in taste and warm in nature, it enters the spleen, stomach, and lung meridians. It is the chief herb in the classic formula Banxia Houpu Decoction, and here it also serves as the chief herb, effectively drying dampness and resolving phlegm. Targeting the core pathogenesis of phlegm-dampness obstructing the lungs and the upward reversal of lung qi, it directly eliminates phlegm-dampness and calms the upward-reversing lung qi. Simultaneously, Pinellia ternata enters the spleen meridian, assisting the spleen in its function of transformation and transportation, thus eliminating the source of phlegm production, consistent with the theory that "the spleen is the source of phlegm, and the lungs are the receptacle for phlegm."

[0029] Assistant herbs (Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, Pheretima aspergillum): assist the principal herbs, address both the symptoms and the root cause, and enhance the therapeutic effect.

[0030] Scutellaria baicalensis: Bitter in taste and cold in nature, it enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It excels at clearing lung heat and drying dampness. For chronic cough with the concurrent symptom of "phlegm-dampness stagnation transforming into heat," it clears and resolves stagnant heat in the lung meridian, preventing the heat evil from further transforming fluids into phlegm and aggravating phlegm-dampness obstructing the lungs. Additionally, Scutellaria baicalensis clears heat and dries dampness, assisting Pinellia ternata and Magnolia officinalis in resolving phlegm-dampness. Together with the principal herb Bupleurum chinense, it can dispel wind-heat in the Shaoyang meridian, expel internal and external evils, and enhance the overall effect of the formula in dispelling wind and clearing heat, harmonizing the exterior and interior, thus strengthening the "regulating the pivot and expelling evil" effect of the principal herb from the perspectives of Qi and heat.

[0031] Magnolia officinalis: bitter and pungent in taste, warm in nature, and enters the spleen, stomach, lung, and large intestine meridians. It excels at promoting qi circulation, dispersing stagnation, drying dampness and resolving phlegm, and relieving fullness by lowering qi. Its nature is mainly descending, which can enhance the qi-lowering, phlegm-resolving, asthma-relieving, and cough-suppressing effects of Pinellia ternata. Magnolia officinalis can not only promote the qi circulation of the spleen and stomach and assist the spleen in its transformation and transportation functions, but also reduce the generation of phlegm and dampness from the source. Since it enters the large intestine meridian, it can also promote the downward flow of qi in the internal organs. The lung and large intestine are internally and externally related. When the qi of the large intestine is unobstructed, it helps the lung qi to descend. This is the principle of "treating both internal organs and viscera".

[0032] Almond and Platycodon grandiflorus: Almond is bitter and warm, entering the lung and large intestine meridians. It excels at descending rebellious lung qi, relieving cough and asthma, moistening dryness and resolving phlegm. It can strengthen the descending qi power of the principal herb and Magnolia officinalis, allowing the rebellious lung qi to descend quickly, thus relieving cough and asthma. Its laxative properties also help to clear the bowels and descend lung qi. Platycodon grandiflorus is bitter, pungent, and neutral, specifically entering the lung meridian. It promotes lung function, soothes the throat, and eliminates phlegm. It assists Bupleurum in dispelling wind and promoting lung function, relieving stagnation in the lung meridian. When combined with almond, Magnolia officinalis, and other qi-descending herbs, one promotes and the other descends, restoring the dynamic balance of lung qi's dispersing and descending functions, directly regulating the lung's qi mechanism.

[0033] Earthworm: Salty and cold, it enters the liver, lung, and bladder meridians. It clears heat and unblocks the meridians, relieves asthma and promotes urination. It clears phlegm, dampness, and stagnant heat, and unblocks the lung meridians to relieve asthma. It promotes urination and eliminates dampness, which helps Poria to resolve dampness. Its descending nature also helps lung qi to descend. At the same time, it reduces the heat of the warm and drying medicines in the formula, and takes into account the symptoms of stagnant heat. As an insect medicine, earthworm can relieve spasms, unblock the meridians, dispel wind and stop spasms. It can relieve airway spasms and spasmodic cough. It complements the "calming internal wind" effect of the chief medicine Bupleurum, and strengthens the wind-dispelling and spasm-relieving power of the whole formula.

[0034] The adjuvant herbs (Perilla seed, Poria cocos, dried ginger, Schisandra chinensis, Angelica sinensis, Bombyx batryticatus, and Taraxacum mongolicum) each perform their respective functions, work synergistically to enhance efficacy, and restrain any imbalances.

[0035] Perilla seed: Perilla seed is pungent and warm, and enters the lung and large intestine meridians. It is good at lowering qi and resolving phlegm, relieving cough and asthma, and assisting pinellia and apricot kernel in lowering rebellious lung qi.

[0036] Silkworm: Silkworm has a salty, pungent and neutral taste. It enters the liver and lung meridians. It dispels wind and resolves phlegm, disperses nodules and unblocks the meridians. It is good at relieving wind evil in the lung meridian and assisting Bupleurum in dispelling wind. At the same time, it resolves phlegm and disperses nodules, unblocks the meridians and relieves urgency. It is effective for paroxysmal cough caused by wind disturbing the qi and cough and wheezing caused by stagnation of the lung meridians.

[0037] Poria cocos, dried ginger, and schisandra chinensis: Poria cocos is sweet, bland, and neutral in nature, entering the spleen, lung, and kidney meridians. It strengthens the spleen, eliminates dampness, promotes urination, and resolves phlegm. Its sweet and bland nature strengthens the spleen and eliminates the source of phlegm, while its bland nature promotes urination and eliminates dampness, allowing phlegm and dampness to be expelled from the lower burner. When combined with Pinellia ternata and Magnolia officinalis, it combines drying and dampness-eliminating effects, making its phlegm-resolving and dampness-removing power even more pronounced. Dried ginger is pungent and hot, entering the spleen, lung, and stomach meridians. It warms the lungs, transforms phlegm, warms the middle burner, and strengthens the spleen. It is effective for phlegm-dampness obstructing the lungs and lung cold. It warms and disperses cold phlegm in the lungs to help resolve phlegm, warms the middle burner, strengthens the spleen, and prevents the internal generation of cold and dampness. At the same time, it moderates the cold nature of the bitter and cold ingredients in the formula, preventing bitter and cold from damaging Yang. Schisandra chinensis is sour and warm, entering the lung and kidney meridians. It astringes the lungs, stops cough, nourishes the kidneys, and astringes Qi. It is effective for chronic cough that depletes lung Qi and causes the lungs to lose their astringent and descending function. When combined with dried ginger, one warms and the other astringes, one opens and the other closes, which aligns with the principle that "the lungs need to astringe, so eat sour foods to astringe them."

[0038] Angelica sinensis: sweet, pungent, and warm in nature, it enters the liver, heart, and spleen meridians, nourishing and invigorating blood, harmonizing the collaterals, and relieving pain. Its uses are: firstly, the *Shennong Bencao Jing* states that Angelica sinensis can treat coughs; secondly, "to treat wind, first treat the blood, for when the blood flows smoothly, the wind will naturally subside," thus assisting insect-based medicines in clearing the collaterals and extinguishing wind; thirdly, it moistens dryness to counteract the warming and drying properties of other medicines in the formula; and fourthly, it nourishes blood to address the deficiency resulting from prolonged illness.

[0039] Dandelion: bitter, sweet, and cold in nature, it enters the liver, stomach, and lung meridians. It clears heat and detoxifies, reduces swelling and dissipates nodules, and promotes diuresis. It assists Scutellaria baicalensis in clearing heat in the lung meridian and spleen and stomach. Its sweet and cold nature clears heat without harming yin, preventing warm and drying medicines from consuming lung fluids. At the same time, it disperses nodules and resolves phlegm, targeting cough and wheezing caused by phlegm and dampness accumulation.

[0040] The ingenuity of this invention lies not only in inheriting the essence of the classic formula Xiao Chai Hu Tang combined with Ban Xia Hou Po Tang, but also in its innovative use of "Chai Hu" and "Ban Xia" as the principal herbs, establishing the primary principle of treatment that emphasizes both "regulating the liver and treating the lungs" and "resolving phlegm and descending rebellious qi." This elevates the relieving of internal qi stagnation to a strategic level of equal importance with the removal of tangible phlegm and dampness, directly addressing the core pathogenesis of chronic cough's persistent and difficult-to-cure nature. Simultaneously, the ten or twelve assistant herbs are systematically divided into multiple synergistic units based on their core functions, such as "dispersing and descending," "dispelling wind and unblocking the meridians," "strengthening the spleen and warming the middle jiao to consolidate the foundation," and "activating blood, moistening dryness, and clearing heat." This system organizes and clarifies the complex auxiliary forces, collectively constructing a precise support system centered around the principal and assistant herbs, addressing various concurrent symptoms, and maintaining the body's balance.

[0041] The preparation method of the traditional Chinese medicine composition includes the following steps: S1. Accurately weigh each raw material; S2. Place all ingredients in a decoction container, add 6 to 12 times (based on the total weight of the ingredients) of drinking water, and soak at room temperature for 35 to 60 minutes; first bring to a boil over high heat, then reduce to a simmer and decoct for 30 to 50 minutes; filter the first decoction through a strainer. S3. Add 4 to 8 times the amount of drinking water to the dregs, bring to a boil over high heat, then simmer over low heat for 20 to 40 minutes, and filter out the second decoction. S4. Combine the decoctions obtained from the two decoctions to obtain the decoction of the Chinese herbal composition.

[0042] The aforementioned traditional Chinese medicine composition is used to treat chronic cough of the type caused by phlegm-dampness obstructing the lungs and wind-disturbed qi.

[0043] The beneficial effects of this invention are as follows: 1. Theoretical Innovation and Precise Combination: Based on a deep understanding of the pathogenesis, this invention uses Bupleurum and Pinellia as the principal herbs to directly target the core pathogenesis. The assistant herbs enhance the efficacy and take into account concurrent symptoms. The adjuvant herbs comprehensively supplement the pathogenesis and target the condition, so that the medicine guides the medicine to the meridians and harmonizes the middle jiao, strengthens the body and regulates the body, and progresses step by step. It can not only quickly relieve symptoms such as cough, asthma and phlegm, but also fundamentally resolve phlegm and dampness, regulate qi, and protect the lungs and spleen, and prevent recurrence. It conforms to the principle of "treating the symptoms in acute cases and treating the root cause in chronic cases", forming a unique treatment plan.

[0044] 2. Regulating Qi and Promoting the Interaction of Ascending and Descending: Skillfully using the "ascending and descending combination", Bupleurum and Platycodon promote the ascending and dispersing of the lungs, Pinellia, Magnolia officinalis, Apricot kernel and Perilla seed descend the rebellious Qi and calm the lungs, and Dried ginger and Schisandra chinensis open and close, so that the lung Qi can return to normal, which is in line with the physiological characteristics of "the lung governs the dispersing and descending". When the Qi is regulated, the cough will stop.

[0045] 3. Definite efficacy and data support: This invention provides clinical data support for this formulation based on modern evidence-based medicine for the first time. Through standardized retrospective studies and rigorous statistical analysis (P<0.001), quantitative evidence has been used to prove the objectivity and reliability of its efficacy, overcoming the shortcoming of traditional Chinese medicine formulas lacking modern clinical validation.

[0046] 4. High safety and good patient compliance: Through strict processing techniques and drug compatibility, this invention effectively controls potential toxic side effects, ensuring the safety of clinical medication, which is beneficial for long-term treatment and improves patient compliance. Attached Figure Description

[0047] Figure 1 A schematic diagram of the "Traditional Chinese Medicine Syndrome Scoring Scale" is shown; Figure 2 A schematic diagram of the VAS Cough Visual Analogue Scale is shown. Figure 3 A partial illustration of the Leicester Cough Scale is shown. Figure 1 ; Figure 4 A partial illustration of the Leicester Cough Scale is shown. Figure 2 . Detailed Implementation

[0048] Example 1 This embodiment provides a traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi type, comprising the following raw materials in parts by weight: Bupleurum chinense 12g, Scutellaria baicalensis 10g, Pinellia ternata 15g, Magnolia officinalis 12g, Prunus armeniaca 10g, Pheretima aspergillum 10g, Poria cocos 12g, Perilla frutescens 10g, Platycodon grandiflorus 10g, and Angelica sinensis 10g. Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

[0049] The preparation method includes the following steps: accurately weigh each raw material; place all raw materials in a decoction container, add 8 times the amount of drinking water (based on the total weight of the raw materials), and soak at room temperature for 45 minutes; first bring to a boil over high heat, then reduce to a simmer and decoct for 35 minutes; filter out the first decoction (first decoction); add 6 times the amount of drinking water to the dregs again, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter out the second decoction (second decoction); combine the decoctions obtained from the two decoctions to obtain the herbal composition of this example. It can be dispensed and stored in a refrigerator at 3℃~5℃, or further prepared into other dosage forms.

[0050] Example 2 In one preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Bupleurum chinense 12g, Scutellaria baicalensis 10g, Pinellia ternata 15g, Magnolia officinalis 12g, Prunus armeniaca 10g, Pheretima aspergillum 10g, Poria cocos 12g, Perilla frutescens 10g, Platycodon grandiflorus 10g, Angelica sinensis 10g, Bombyx mori 9g, and Taraxacum mongolicum 15g. Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

[0051] The preparation method includes the following steps: accurately weigh each raw material; place all raw materials in a decoction container, add 6 times the amount of drinking water (based on the total weight of the raw materials), and soak at room temperature for 35 minutes; first bring to a boil over high heat, then reduce to a simmer and decoct for 40 minutes; filter out the first decoction (first decoction); add 4 times the amount of drinking water to the dregs again, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter out the second decoction (second decoction); combine the decoctions obtained from the two decoctions to obtain the herbal composition of this example. It can be dispensed and stored in a refrigerator at 3℃~5℃, or further prepared into other dosage forms.

[0052] Example 3 In another preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Bupleurum chinense 12g, Scutellaria baicalensis 10g, Pinellia ternata 15g, Magnolia officinalis 12g, Prunus armeniaca 10g, Pheretima aspergillum 10g, Poria cocos 12g, Perilla frutescens 10g, Platycodon grandiflorus 10g, Angelica sinensis 10g, Bombyx batryticatus 9g, Taraxacum mongolicum 15g, Zingiber officinale 4g, and Schisandra chinensis 6g. Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

[0053] The preparation method includes the following steps: accurately weigh each raw material; place all raw materials in a decoction container, add 10 times the amount of drinking water (based on the total weight of the raw materials), and soak at room temperature for 50 minutes; first bring to a boil over high heat, then reduce to a simmer and decoct for 50 minutes; filter out the first decoction (first decoction); add 8 times the amount of drinking water to the dregs again, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter out the second decoction (second decoction); combine the decoctions obtained from the two decoctions to obtain the herbal composition of this example. It can be dispensed and stored in a refrigerator at 3℃~5℃, or further prepared into other dosage forms.

[0054] To objectively and scientifically evaluate the clinical efficacy of the traditional Chinese medicine composition of this invention (using the decoction obtained in Example 1), researchers conducted a standardized retrospective clinical study. Details are as follows: (1) Inclusion criteria: ① No age or gender restrictions; ② Meets the diagnostic criteria of both traditional Chinese medicine and Western medicine in the "Guidelines for the Diagnosis and Treatment of Cough Variant Asthma in Traditional Chinese Medicine"; ③ Received decoction treatment according to Example 1 at an outpatient clinic between January 2024 and November 2025; ④ Complete records of the chronic cough-related symptoms and syndrome scoring scale before and after treatment (or at the last follow-up) in the medical record, the content of which is as follows: Figures 1-4 As shown.

[0055] (2) Exclusion criteria: ① The presence of other clear causes of cough that require priority treatment, such as: confirmed malignant lung tumors, active pulmonary tuberculosis, acute exacerbation of bronchiectasis, chronic heart failure, known severe gastroesophageal reflux disease, etc.; ② Those who participated in other drug clinical trials during the study period; ③ Those whose medical records are severely missing, making it impossible to conduct effective efficacy or safety evaluations (such as missing post-treatment symptom records); ④ Pregnant or lactating women, and those with a history of allergy to known drug components in the prescription of this study.

[0056] (3) Final enrollment: A total of 90 cases meeting the criteria were included (Table 1).

[0057] (4) Treatment method: All enrolled patients used the modified Chinese herbal decoction of Example 1, one dose per day, taken twice a day, morning and evening.

[0058] (5) Evaluation indicators: The TCM syndrome score, VAS cough visual analog scale, and LCQ Lester cough scale were used as the core efficacy evaluation indicators. The TCM syndrome score mainly assesses related syndromes such as cough, expectoration, sore throat, chills and fever, headache and body pain, chest tightness and shortness of breath, and tongue coating; the VAS cough visual analog scale mainly assesses the patient's overall subjective feeling about the severity of cough; the LCQ Lester cough scale mainly assesses the multidimensional impact on the patient's quality of life, including: physiological domain (e.g., physical strength, sleep), psychological domain (e.g., emotion, attention), and social domain (e.g., social interaction, work).

[0059] (6) Screening and Data Extraction of Study Subjects: Cases meeting the criteria were screened using the outpatient electronic medical record system according to established inclusion and exclusion standards. Basic information was extracted from the outpatient medical records of the selected eligible cases. The "Chronic Cough Related Symptoms and Syndrome Scoring Scale" was completed based on the medical records to determine the initial severity of the patient's condition upon enrollment. For example, a retrospective scoring was performed based on the description of symptoms and syndromes in the patient's case. Data was extracted from the medical records of the patient's second follow-up visit or regular follow-up. A follow-up study (disease prognosis) scale was completed based on the medical records from the follow-up visit to assess the patient's prognosis.

[0060] (7) Data statistics and analysis: Table 1. Scores of 90 patients before and after treatment In Table 1, ID represents the patient number, TCM-B represents the TCM syndrome score before treatment, TCM-A represents the TCM syndrome score after treatment, VAS-B represents the visual analog scale score for cough before treatment, VAS-A represents the visual analog scale score for cough before treatment, LCQ-B represents the Leicester Cough Scale score before treatment, LCQ-A represents the Leicester Cough Scale score after treatment, TOTAL-B represents the total score for chronic cough before treatment, and TOTAL-A represents the total score for chronic cough after treatment.

[0061] Table 2. Results of Normality Test In Table 2, 'a' represents the Lilliefers significance level correction.

[0062] Statistical analysis was performed using SPSS 26.0 software. Quantitative data were first tested for normality using the Shapiro-Wilk test. Data conforming to a normal distribution were expressed as mean ± standard deviation (x ± s) and analyzed using a paired samples t-test; data not conforming to a normal distribution were expressed as median (lower quartile, upper quartile) [M(P25,P75)] and analyzed using the Wilcoxon signed-rank test. A p-value < 0.05 was considered statistically significant. If Sig. > 0.05, the difference in the indicator was considered to follow a normal distribution; if Sig. < 0.05, the difference in the indicator was considered not to follow a normal distribution.

[0063] Table 3. Statistical Results of TCM Syndrome Scores and Total Scores Before and After Treatment Table 4. Results of Paired Sample Test Table 5. Statistical table of median and percentile values ​​of VAS and LCQ before and after treatment. Table 6. Results of the Wilcoxon Signed Rank Tests for AVS and LCQ In Table 6, a indicates that the VAS score after treatment is less than the VAS score before treatment; b indicates that the VAS score after treatment is greater than the VAS score before treatment; c indicates that the VAS score after treatment is equal to the VAS score before treatment; d indicates that the LCQ score after treatment is less than the LCQ score before treatment; e indicates that the LCQ score after treatment is greater than the LCQ score before treatment; and f indicates that the LCQ score after treatment is equal to the LCQ score before treatment.

[0064] Table 7. Results of the Wilcoxon Signed Rank Test for AVS and LCQ In Table 7, 'a' indicates a positive rank.

[0065] All data were statistically analyzed using SPSS 26.0. A normality test was performed on the difference in scores before and after treatment for 90 patients. Table 2 shows that the TCM syndrome score (Sig. 0.145) > 0.05 and the total score (Sig. 0.290) > 0.05; therefore, a paired-samples t-test was used, and the results are shown in Tables 3-4. Table 2 also shows that the VAS score (Sig. 0.001) and LCQ score (Sig. 0.001) < 0.05; therefore, a Wilcoxon signed-rank test was used, and the results are shown in Tables 5-7.

[0066] (8) Research results: All patient indicators showed significant changes compared to pre-treatment levels (all P < 0.001), as detailed below: Regarding symptom scores: the TCM syndrome score decreased significantly from (9.80±2.649) before treatment to (4.39±2.277); the VAS cough visual analog scale score decreased significantly from 7.00 (6.00, 7.00) before treatment to 3.0 (2.0, 4.0).

[0067] Regarding quality of life: The total score on the Leicester Cough Scale (LCQ) decreased from 9.00 (7.75, 10.00) before treatment to 5 (3.00, 6.00), indicating a significant improvement in cough-related quality of life.

[0068] In terms of overall efficacy: the total treatment score decreased significantly from (25.47±5.211) points to (12.33±4.781) points.

[0069] Safety observation: During the treatment period, no drug-related serious adverse events were reported in any of the 90 patients, indicating that the drug of this invention has good safety in clinical application.

[0070] The above results suggest that this treatment regimen can comprehensively and significantly improve the clinical symptoms and quality of life of patients with cough.

[0071] (9) Clinical conclusion: This retrospective clinical study, through rigorous statistical analysis, confirmed that the traditional Chinese medicine composition provided by this invention can significantly reduce the TCM syndrome score, AVS score, and LCQ Leicester score in patients with chronic cough, with highly statistically significant differences (P<0.001). This directly reflects the definite efficacy of this formula in relieving cough frequency, severity, and related TCM syndrome-related symptoms (such as itchy throat and phlegm accumulation). The results objectively and conclusively demonstrate that the drug of this invention has a clear and significant clinical efficacy for chronic cough caused by phlegm-dampness obstructing the lungs and wind-disturbed qi, with acceptable safety. More importantly, the decrease in the LCQ Leicester score, from the perspectives of patient subjective experience, psychological and social functioning, confirms that this approach not only targets the 'disease' but also focuses on improving the overall state of the 'person'.

[0072] The above embodiments are only used to illustrate the technical ideas and features of the present invention, and are not intended to be unique or to limit the present invention. Those skilled in the art should understand that various changes or equivalent substitutions made to the present invention without departing from its scope are all within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi, characterized in that, The ingredients include the following parts by weight: Bupleurum chinense 10-18 parts, Scutellaria baicalensis 7-14 parts, Pinellia ternata 10-18 parts, Magnolia officinalis 10-14 parts, Prunus armeniaca 8-12 parts, Pheretima aspergillum 7-12 parts, Poria cocos 10-15 parts, Perilla frutescens 6-12 parts, Platycodon grandiflorus 6-12 parts, and Angelica sinensis 8-12 parts; among them, Bupleurum chinense and Pinellia ternata are the principal herbs, Scutellaria baicalensis, Magnolia officinalis, Prunus armeniaca, Platycodon grandiflorus, and Pheretima aspergillum are the assistant herbs, and the rest are adjuvant herbs.

2. The traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi type according to claim 1, characterized in that, It also includes 6 to 12 parts of silkworm pupae and 10 to 20 parts of dandelion.

3. The traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi type according to claim 2, characterized in that, It also includes 3 to 5 parts dried ginger and 5 to 8 parts schisandra chinensis.

4. The traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi type according to claim 1, characterized in that, Bupleurum 12 parts, Scutellaria baicalensis 10 parts, Pinellia ternata 15 parts, Magnolia officinalis 12 parts, Prunus armeniaca 10 parts, Pheretima aspergillum 10 parts, Poria cocos 12 parts, Perilla frutescens 10 parts, Platycodon grandiflorus 10 parts, Angelica sinensis 10 parts.

5. The traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi type according to claim 2, characterized in that, Nine portions of silkworm pupae and 15 portions of dandelion.

6. The traditional Chinese medicine composition for treating chronic cough of the phlegm-dampness obstructing the lungs and wind-disturbed qi type according to claim 3, characterized in that, 4 parts dried ginger, 6 parts schisandra chinensis.

7. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 6, characterized in that, Includes the following steps: S1. Accurately weigh each raw material; S2. Place all ingredients in a decoction container, add 6 to 12 times (based on the total weight of the ingredients) of drinking water, and soak at room temperature for 35 to 60 minutes; first bring to a boil over high heat, then reduce to a simmer and decoct for 30 to 50 minutes; filter the first decoction through a strainer. S3. Add 4 to 8 times the amount of drinking water to the dregs, bring to a boil over high heat, then simmer over low heat for 20 to 40 minutes, and filter out the second decoction. S4. Combine the decoctions obtained from the two decoctions to obtain the decoction of the Chinese herbal composition.

8. The application of the traditional Chinese medicine composition according to any one of claims 1 to 6, characterized in that, It is used to treat chronic cough caused by phlegm-dampness obstructing the lungs and wind-disturbed qi.

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