Traditional Chinese medicine composition for treating chronic refractory cough and preparation method and application thereof
By using a combination of traditional Chinese medicine to clear the lungs, dispel pathogens, and resolve phlegm, the treatment of chronic and refractory cough has been solved, achieving rapid improvement in cough and accompanying symptoms, and exhibiting stable long-term efficacy and high safety.
Patent Information
- Application Number
- CN202511827250.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-05
- Publication Date
- 2026-02-24
AI Technical Summary
Existing technologies are insufficient to effectively treat chronic refractory cough, especially refractory chronic cough caused by COVID-19 infection, and conventional treatment methods often lead to prolonged and difficult-to-cure cough.
A traditional Chinese medicine composition, including Belamcanda chinensis, processed Ephedra sinica, Asarum heterotropoides, and Pinellia ternata sap, is prepared by water extraction. It is used to relieve cough and promote lung function, and to treat cough by lowering qi. It targets the syndrome of "residual evil transforming into turbidity and lung qi obstruction", expelling evil, promoting lung function and dispersing evil, lowering qi and resolving phlegm. It also combines the antiviral and immunomodulatory effects of modern pharmacological components.
It significantly improves chronic refractory cough and accompanying symptoms such as nasal congestion and decreased sense of smell, with good overall efficacy, stable and safe long-term efficacy, and no obvious adverse reactions.
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Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating chronic refractory cough, its preparation method, and its uses. Background Technology
[0002] Chronic cough has complex causes, and misdiagnosis and mistreatment are common in clinical practice. Currently, some patients with chronic cough often cannot be diagnosed despite comprehensive and standardized examinations, or their cough does not significantly improve after empirical treatment for a known cause; this is known as refractory chronic cough. A nationwide multicenter survey on the etiology of chronic cough shows that the proportion of patients with refractory chronic cough is approximately 8.4%, and this proportion has increased particularly after COVID-19 infection, becoming a pressing and challenging problem in clinical practice.
[0003] In traditional Chinese medicine, refractory chronic cough is categorized as "prolonged cough" or "stubborn cough." Regarding its etiology and pathogenesis, physicians throughout history have offered various insights and treatment methods. Generally, the main themes are exogenous and endogenous factors. As stated in *Zheng Zhi Hui Bu* (Collection of Diagnostic and Treatment Methods), "The lungs belong to the metal element, like a bell. A bell will not ring unless struck. Wind, cold, summer heat, dampness, dryness, and fire—the six external evils—strike from the outside, causing it to ring. Excessive labor, emotional stress, improper diet, and the fire of roasting and baking attack from within, also cause it to ring." Exogenous pathogenic factors (wind, cold, summer heat, dampness, dryness, and fire) invade the lungs, leading to cough. Endogenous causes are often due to emotional distress, improper diet, overwork, prolonged illness, and damage to the internal organs, all of which affect the lungs. Exogenous and endogenous coughs are interconnected. The key to its pathogenesis lies in the obstruction of lung qi, but it is also closely related to the functions of other organs, such as liver fire rising, spleen deficiency producing phlegm, and kidney failing to receive qi. In other words, "All five viscera and six bowels can cause cough, not just the lungs." In terms of treatment, physicians should "remove the instrument that makes the bell ring," that is, remove the cause of the cough, rather than using modern medical cough suppressants to "grind and wear down the bell every day." If the cause is not treated, simply suppressing the cough will make it linger and difficult to cure, just like "a bell that is damaged and its sound is hoarse but still rings as before."
[0004] Therefore, there is an urgent need to develop a traditional Chinese medicine composition that can effectively treat refractory chronic cough. Summary of the Invention
[0005] In order to overcome the problems existing in the prior art, the present invention, based on the treatment ideas of opening the door to expel the enemy, driving away evil spirits, clearing the lungs and relieving pain, and lowering qi to treat cough, provides a traditional Chinese medicine composition for treating chronic refractory cough, its preparation method and uses.
[0006] To achieve the above and other related objectives, the present invention adopts the following technical solution: The first aspect of the present invention provides a traditional Chinese medicine composition for treating chronic refractory cough, comprising the following components in the indicated weight proportions: 10-20 parts of Belamcanda chinensis, 4-8 parts of processed Ephedra sinica, 2-5 parts of Asarum heterotropoides, 10-20 parts of Pinellia ternata with bamboo sap, 6-12 parts of raw Glycyrrhiza uralensis, 10-20 parts of Bupleurum chinense, 10-20 parts of stir-fried Scutellaria baicalensis, 6-12 parts of Citrus aurantium, 6-12 parts of Platycodon grandiflorus, 10-20 parts of processed Perilla frutescens, 6-12 parts of Prunus armeniaca, 30-50 parts of Fagopyrum dibotrys, 9-15 parts of Phyllanthus urinaria, 9-15 parts of Phyllanthus urinaria, and 20-40 parts of Trichosanthes kirilowii peel.
[0007] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in the indicated weight ratios: 15 parts Belamcanda chinensis, 6 parts processed Ephedra sinica, 3 parts Asarum heterotropoides, 15 parts Pinellia ternata with bamboo sap, 9 parts raw Glycyrrhiza uralensis, 15 parts Bupleurum chinense, 15 parts stir-fried Scutellaria baicalensis, 9 parts Citrus aurantium, 9 parts Platycodon grandiflorus, 15 parts processed Perilla frutescens, 9 parts Prunus armeniaca, 40 parts Fagopyrum dibotrys, 12 parts Phyllanthus urinaria, 12 parts Phyllanthus urinaria, and 30 parts Trichosanthes kirilowii peel.
[0008] A second aspect of the present invention provides a method for preparing the aforementioned traditional Chinese medicine composition, wherein the preparation method is a water extraction method.
[0009] In some embodiments of the present invention, the preparation method is as follows: take each component raw material, add water and decoct, filter, add an appropriate amount of water to the medicinal material, decoct again, filter, and combine the two filtrates to obtain the final product.
[0010] In some embodiments of the present invention, the amount of water added during the decoction is 1.8 to 4 times the total weight of the raw materials, preferably 2.5 to 3 times. The amount of water added during the second decoction is 1 to 3 times the total weight of the raw materials, preferably 1.4 to 2 times.
[0011] In some embodiments of the present invention, the decocting time is 25-35 min, which can be 25-30 min, or 30-35 min, preferably 30 min; the re-decocting time is 15-25 min, which can be 15-20 min, or 20-25 min, preferably 20 min.
[0012] A third aspect of the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating chronic refractory cough.
[0013] In some embodiments of the present invention, the chronic refractory cough conforms to the syndrome of residual pathogenic factors transforming into turbidity and lung qi obstruction in traditional Chinese medicine.
[0014] A fourth aspect of the present invention provides a traditional Chinese medicine preparation comprising the aforementioned traditional Chinese medicine composition.
[0015] In some embodiments of the present invention, the traditional Chinese medicine preparation is an oral preparation, including solutions, granules, pills, tablets, capsules, syrups, and sprays.
[0016] Pharmaceutically acceptable excipients include, but are not limited to, pharmaceutically acceptable carriers, diluents, fillers, binders, and other excipients. Therapeutic inert inorganic or organic carriers known in the art include, but are not limited to, lactose, corn starch or derivatives thereof, talc, vegetable oils, waxes, fats, polyhydroxy compounds such as polyethylene glycol, water, sucrose, ethanol, glycerin, and the like, as well as various preservatives, lubricants, dispersants, and flavoring agents. Humectants, antioxidants, sweeteners, colorants, stabilizers, salts, buffers, and the like may also be added as needed to aid in the stability of the formulation or to contribute to its activity or bioavailability, or to produce an acceptable taste or odor when taken orally. Traditional Chinese medicine preparations, such as granules and ointments, can be prepared by conventional methods. The pharmaceutical compositions of the present invention can also be used with other therapeutic agents.
[0017] In one embodiment, the traditional Chinese medicine preparation is an oral preparation, including but not limited to solutions, granules, pills, tablets, capsules, syrups, and sprays.
[0018] After extracting the effective components from the traditional Chinese medicine composition, the aforementioned traditional Chinese medicine preparations can be prepared using conventional pharmaceutical excipients and additives.
[0019] The Chinese medicinal materials used in the embodiments of this invention are all listed in the Chinese Pharmacopoeia and meet the pharmacopoeia's quality requirements. Specifically, the properties, meridian tropism, and indications of these Chinese medicinal materials are as follows: (1)shoot dry Properties and Channels Entered: Bitter, cold. Enters the Lung Channel.
[0020] Functions and indications: Clears heat and detoxifies, resolves phlegm, and soothes the throat. Used for heat-toxin phlegm-fire stagnation, sore throat, excessive phlegm, cough, and asthma.
[0021] Ephedra Properties and Channels Entered: Pungent, slightly bitter, warm. Enters the Lung and Bladder channels.
[0022] Functions and indications: Induces sweating and dispels cold, clears the lungs and relieves asthma, promotes diuresis and reduces edema. Used for common cold due to wind-cold, chest tightness and cough, edema due to wind-dampness; bronchial asthma.
[0023] Processing method for processed ephedra: Take ephedra segments and stir-fry them using the honey-processing method until they are no longer sticky. Use 20 kg of refined honey for every 100 kg of ephedra. After honey processing, the ephedra is warm and moist in nature, and its pungent and diaphoretic effects are moderated, making it more effective in relieving lung congestion and asthma.
[0024] Asarum Properties and Channels Entered: Pungent, warm. Slightly toxic. Enters the Heart, Lung, and Kidney channels.
[0025] Functions and indications: Relieves exterior syndromes and dispels cold, dispels wind and relieves pain, clears the nasal passages, warms the lungs and resolves phlegm. Used for common cold due to wind-cold, headache, toothache, nasal congestion and runny nose, rhinitis, sinusitis, rheumatic pain, cough and asthma due to phlegm.
[0026] Pinellia Properties and Channels Entered: Pungent, warm. Enters the spleen, stomach, and lung channels.
[0027] Functions and indications: It dries dampness and resolves phlegm, relieves nausea and vomiting, and dissipates lumps and nodules. It is used for cough and asthma with excessive phlegm, dizziness and palpitations due to phlegm retention, dizziness due to wind-phlegm, headache due to phlegm syncope, vomiting and nausea, chest and epigastric fullness, and globus hystericus; when used externally, it is used to treat carbuncles and phlegm nodules.
[0028] Bamboo sap processing method for Pinellia: Soak Pinellia until there is no dry core inside, then boil it together with ginger, alum, and bamboo sap until the juice is exhausted. Remove and dry. After processing with bamboo sap, its warming and drying properties are greatly reduced, making it good at clearing heat and resolving phlegm, calming wind and relieving convulsions.
[0029] licorice Properties and Channels Entered: Sweet, neutral. Enters the Heart, Lung, Spleen, and Stomach channels.
[0030] Functions and indications: Clears heat and detoxifies, eliminates phlegm and relieves cough, relieves spasms and pain. Used for sore throat, carbuncles and boils, drug and food poisoning, cough with excessive phlegm, and abdominal and limb spasms and pain.
[0031] Bupleurum Properties and Channels Entered: Bitter, slightly cold. Enters the Liver, Gallbladder, and Lung channels.
[0032] Functions and indications: Relieves fever, soothes the liver and relieves depression, and invigorates Yang Qi. Used for fever due to colds, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.
[0033] Scutellaria baicalensis Properties and Channels Entered: Bitter, cold. Enters the Lung, Gallbladder, Spleen, Large Intestine, and Small Intestine channels.
[0034] Functions and indications: Clears heat and dries dampness, drains fire and detoxifies, stops bleeding, and calms the fetus. Used for damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, blood-heat vomiting and nosebleeds, carbuncles and boils, and threatened abortion.
[0035] Method for preparing stir-fried Scutellaria baicalensis: Take clean Scutellaria baicalensis slices and stir-fry them using the same method as for plain stir-frying until the surface is slightly charred. After stir-frying, its bitter and cold properties are slightly reduced, and it is often used to stabilize pregnancy.
[0036] Citrus aurantium Properties and Channels Entered: Bitter, pungent, sour, slightly cold. Enters the Spleen and Stomach channels.
[0037] Functions and indications: Regulates Qi and relieves chest tightness, promotes circulation and eliminates bloating. Used for Qi stagnation in the chest and hypochondrium, distension and pain, indigestion, phlegm retention, and organ prolapse.
[0038] Platycodon grandiflorus Properties and Channels Entered: Bitter, pungent, neutral. Enters the Lung Channel.
[0039] Functions and indications: Clears the lungs, soothes the throat, eliminates phlegm, and drains pus. Used for cough with excessive phlegm, chest tightness, sore throat and hoarseness, and lung abscess with purulent sputum.
[0040] Su Zi Properties and Channels Entered: Pungent, warm. Enters the Lung Channel.
[0041] Functions and indications: It regulates qi and resolves phlegm, relieves cough and asthma, and moistens the intestines to promote bowel movement. It is used for phlegm accumulation and qi stagnation, cough and asthma, and constipation due to intestinal dryness.
[0042] Preparation method for roasted perilla seeds: Take clean perilla seeds and stir-fry them using the honey-roasting method until they are no longer sticky. Honey roasting enhances their effects of moisturizing the lungs, relieving cough, and calming asthma.
[0043] almond Properties and Channels Entered: Bitter, slightly warm; slightly toxic. Enters the Lung and Large Intestine channels.
[0044] Functions and indications: It relieves cough and asthma, and moistens the intestines to promote bowel movements. It is used for cough and asthma, chest fullness with excessive phlegm, and constipation due to intestinal dryness.
[0045] Golden buckwheat Properties and Channels Entered: Slightly pungent, astringent, and cool. Enters the Lung Channel.
[0046] Functions and indications: Clears heat and detoxifies, drains pus and removes blood stasis. Used for lung abscess with purulent sputum, lung heat with cough and wheezing, and tonsillitis with swelling and pain.
[0047] Tianjiang Shell Properties and Channels Entered: Sweet, pungent, neutral. Enters the Lung and Liver channels.
[0048] Functions and indications: Clears the lungs and resolves phlegm, relieves cough and asthma, and promotes rash eruption. Used for cough with excessive phlegm, asthma, and poor rash eruption.
[0049] Brocade Lantern Properties and Channels Entered: Bitter, cold. Enters the Lung Channel.
[0050] Functions and indications: Clears heat and detoxifies, soothes the throat and resolves phlegm, promotes urination. Used for sore throat and hoarseness, cough with phlegm and heat, and difficulty urinating; externally used to treat pemphigus and eczema.
[0051] Trichosanthes peel Properties and Channels Entered: Sweet, cold. Enters the Lung and Stomach channels.
[0052] Functions and indications: Clears heat and phlegm, promotes qi circulation and relieves chest tightness. Used for cough with phlegm and heat, chest tightness and hypochondriac pain.
[0053] Based on years of clinical experience, the inventors of this invention propose that "turbid pathogens harm the lungs and obstruct lung qi" is the core pathogenesis of refractory chronic cough. Through clinical observation and analysis, they believe that its etiology is multifaceted, involving external pathogenic factors such as wind-cold, wind-heat, summer-dampness, dryness, and epidemic pathogens (such as the novel coronavirus). In particular, external wind-cold pathogens accompanied by dampness, phlegm, or turbidity, or environmental pollutants such as smog (PM2.5), dust, cigarette smoke, and cooking fumes, etc., are considered "external turbidity" or "filthy qi." External or internal turbid pathogens dry out the lungs, causing the lungs to lose their clear qi. When the body is clear of pathogenic factors, coughing occurs frequently. Simultaneously, turbid pathogens (whether external or internal) invade the lung's defensive qi. Their heavy, turbid, and sticky nature makes it difficult for the body to clear them, thus obstructing the flow of qi (manifested as cough, chest tightness, sticky and difficult-to-expectorate phlegm), clouding the sensory orifices (manifested as nasal congestion, hoarseness, decreased or abnormal sense of smell), damaging the lung collaterals (manifested as severe cough with chest and rib pain, coughing with blood in the sputum), suppressing the clear yang (manifested as heaviness in the head and body, chest tightness and epigastric fullness), and affecting the defensive qi function (manifested as recurrent colds, with the cough worsening again after a cold). Therefore, the cough is persistent and recurring. In summary, the inventor believes that "residual pathogenic factors transforming into turbidity, and lung qi obstruction" is a relatively common TCM syndrome in clinical practice. For this type of refractory chronic cough, the aim is to promote the flow of qi, dispel wind and disperse the exterior, clear the sensory orifices, and expel turbid pathogens, thereby restoring the lung's function of clearing and dispersing. When the lung's function of clearing and dispersing is restored, the cough will naturally stop.
[0054] The traditional Chinese medicine composition “Xuanfei Juanzhuo Decoction” of the present invention has the following characteristics: it combines the meaning of “Shegan Mahuang Decoction” (from “Synopsis of Prescriptions of the Golden Chamber”) and “Qingjin Huatan Decoction” (from “General Principles of Medicine”) to treat cough by clearing the lungs, relieving exterior symptoms, resolving phlegm and reducing turbidity. Bupleurum in this formula dispels wind and releases the exterior, expelling any remaining pathogens; Belamcanda chinensis and Ephedra sinica promote lung function and dispel cold, relieving airway spasms; Apricot kernel and Perilla frutescens descend qi and reduce turbidity, assisting the lung's descending function; Asarum heterotropoides is warm and pungent, clearing blocked lung orifices; Bamboo sap, Pinellia ternata, Trichosanthes kirilowii peel, and Gynostemma pentaphyllum clear the lungs and dissipate nodules, resolving internal phlegm; Citrus aurantium and Platycodon grandiflorus ascend and descend, regulating the lung's qi, and together with Glycyrrhiza uralensis, they also have a soothing effect on the throat; Scutellaria baicalensis, Fagopyrum dibotrys, and Physalis alkekengi are used together to clear heat and detoxify, soothe the throat and relieve numbness; Glycyrrhiza uralensis clears heat and detoxifies, and also harmonizes the other herbs; all the herbs work together to promote lung function, dispel pathogens from the exterior, descend qi, resolve phlegm and eliminate turbidity, allowing the remaining pathogens to be released from the exterior, and the phlegm and turbidity to descend from the large intestine (the lung and large intestine are internally and externally related), thus eliminating and expelling the remaining pathogens and phlegm and turbidity, restoring the lung's function of clearing and descending, and stopping the cough.
[0055] In addition, modern pharmacological studies have shown that Physalis alkekengi, Scutellaria baicalensis, Glycyrrhiza uralensis, and Fagopyrum cymosum in the formula all have anti-Staphylococcus aureus, antiviral, and immunomodulatory effects.
[0056] Compared with the prior art, the present invention has the following beneficial effects: 1. The traditional Chinese medicine composition provided by this invention can comprehensively and significantly improve various symptoms of "residual pathogenic factors transforming into turbidity and lung qi obstruction syndrome", demonstrating the precision of its "clearing the lungs and eliminating turbidity" treatment method. When treating chronic intractable cough (diagnosed as residual pathogenic factors transforming into turbidity and lung qi obstruction syndrome), it can not only quickly and significantly improve the core symptoms such as cough and phlegm, but also effectively relieve accompanying symptoms such as nasal congestion and decreased sense of smell, and has a good comprehensive therapeutic effect.
[0057] 2. The traditional Chinese medicine composition provided by this invention, in addition to its short-term antitussive and expectorant effects, also has a relatively stable long-term effect after treating the underlying cause of the disease. The efficacy is definite, and no obvious adverse reactions were observed in any patient during the entire treatment process. It has high safety and good clinical application value. Detailed Implementation
[0058] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention. Test methods in the following embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the respective manufacturers.
[0059] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the present invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art. In addition to the specific methods, apparatus, and materials used in the embodiments, based on the knowledge of the prior art possessed by one of ordinary skill in the art and the description of this invention, any prior art methods, apparatus, and materials similar to or equivalent to those described, apparatus, and materials in the embodiments of this invention may be used to implement the present invention.
[0060] Unless otherwise stated, the experimental methods, detection methods and preparation methods disclosed in this invention all adopt conventional techniques in this technical field.
[0061] Example 1 A traditional Chinese medicine composition for treating chronic refractory cough comprises the following components in the indicated weight proportions: 10g of Belamcanda chinensis, 4g of processed Ephedra sinica, 2g of Asarum heterotropoides, 10g of Pinellia ternata (processed with bamboo sap), 6g of raw Glycyrrhiza uralensis, 10g of Bupleurum chinense, 10g of processed Scutellaria baicalensis, 6g of Citrus aurantium, 6g of Platycodon grandiflorus, 10g of processed Perilla frutescens, 6g of Prunus armeniaca, 30g of Fagopyrum dibotrys, 9g of Gynostemma pentaphyllum, 9g of Physalis alkekengi, and 20g of Trichosanthes kirilowii peel.
[0062] A method for preparing a traditional Chinese medicine composition for treating chronic refractory cough includes the following steps: 10g of Belamcanda chinensis, 4g of processed Ephedra sinica, 2g of Asarum heterotropoides, 10g of Pinellia ternata (processed with bamboo sap), 6g of raw Glycyrrhiza uralensis, 10g of Bupleurum chinense, 10g of stir-fried Scutellaria baicalensis, 6g of Citrus aurantium, 6g of Platycodon grandiflorus, 10g of processed Perilla frutescens, 6g of Prunus armeniaca, 30g of Fagopyrum dibotrys, 9g of Gynostemma pentaphyllum, 9g of Physalis alkekengi, and 20g of Trichosanthes kirilowii peel are decocted in 310mL of water for 25 minutes, filtered, and the residue is then decocted again in 220mL of water for 15 minutes, filtered, and the two filtrates are combined to obtain the final product.
[0063] Example 2 A traditional Chinese medicine composition for treating chronic refractory cough comprises the following components in the indicated weight proportions: 15g of Belamcanda chinensis, 6g of processed Ephedra sinica, 3g of Asarum heterotropoides, 15g of Pinellia ternata (processed with bamboo sap), 9g of raw Glycyrrhiza uralensis, 15g of Bupleurum chinense, 15g of stir-fried Scutellaria baicalensis, 9g of Citrus aurantium, 9g of Platycodon grandiflorus, 15g of processed Perilla frutescens, 9g of Prunus armeniaca, 40g of Fagopyrum dibotrys, 12g of Gynostemma pentaphyllum, 12g of Physalis alkekengi, and 30g of Trichosanthes kirilowii peel.
[0064] A method for preparing a traditional Chinese medicine composition for treating chronic refractory cough includes the following steps: 15g of Belamcanda chinensis, 6g of processed Ephedra sinica, 3g of Asarum heterotropoides, 15g of Pinellia ternata (processed with bamboo sap), 9g of raw Glycyrrhiza uralensis, 15g of Bupleurum chinense, 15g of stir-fried Scutellaria baicalensis, 9g of Citrus aurantium, 9g of Platycodon grandiflorus, 15g of processed Perilla frutescens, 9g of Prunus armeniaca, 40g of Fagopyrum dibotrys, 12g of Gynostemma pentaphyllum, 12g of Physalis alkekengi, and 30g of Trichosanthes kirilowii peel are decocted in 400mL of water for 30 minutes, filtered, and the residue is then decocted again in 300mL of water for 20 minutes, filtered, and the two filtrates are combined to obtain the final product.
[0065] Example 3 A traditional Chinese medicine composition for treating chronic refractory cough comprises the following components in the indicated weight proportions: 20g of Belamcanda chinensis, 8g of processed Ephedra sinica, 5g of Asarum heterotropoides, 20g of Pinellia ternata (processed with bamboo sap), 12g of raw Glycyrrhiza uralensis, 20g of Bupleurum chinense, 20g of stir-fried Scutellaria baicalensis, 12g of Citrus aurantium, 12g of Platycodon grandiflorus, 20g of processed Perilla frutescens, 12g of Prunus armeniaca, 50g of Fagopyrum dibotrys, 15g of Gynostemma pentaphyllum, 15g of Physalis alkekengi, and 40g of Trichosanthes kirilowii peel.
[0066] A method for preparing a traditional Chinese medicine composition for treating refractory cough includes the following steps: 20g of Belamcanda chinensis, 8g of processed Ephedra sinica, 5g of Asarum heterotropoides, 20g of Pinellia ternata (processed with bamboo sap), 12g of raw Glycyrrhiza uralensis, 20g of Bupleurum chinense, 20g of stir-fried Scutellaria baicalensis, 12g of Citrus aurantium, 12g of Platycodon grandiflorus, 20g of processed Perilla frutescens, 12g of Prunus armeniaca, 50g of Fagopyrum dibotrys, 15g of Gynostemma pentaphyllum, 15g of Physalis alkekengi, and 40g of Trichosanthes kirilowii peel are decocted in 450mL of water for 30 minutes, filtered, and the residue is then decocted again in 350mL of water for 20 minutes, filtered, and the two filtrates are combined to obtain the final product.
[0067] Clinical data Preliminary Clinical Work: In recent years, the "Xuanfei Juanzhuo" formula has been used to treat dozens of patients with chronic refractory cough of the "residual evil transforming into turbidity and lung qi obstruction" type. These patients ranged in age from 30 to 70 years old. Most of these patients had sought treatment at traditional Chinese medicine clinics after failing to respond to Western medicine treatments such as cough suppressants and hormones or being unable to tolerate neuromodulators. After two weeks of treatment with the herbal composition of this invention, the clinical symptoms of all patients improved to varying degrees. Moreover, after 4-8 weeks of continuous treatment, more than half of the cases remained symptom-free during a follow-up period of six months or one year. This suggests that in addition to the short-term cough-suppressing and expectorant effects, this formula also has a relatively stable long-term efficacy after treating the underlying cause.
[0068] Clinical efficacy observation: The subjects were 61 patients aged 28-75 years who visited and were diagnosed with chronic refractory cough at Shanghai Pudong New Area Gongli Hospital between July 2022 and December 2024. They were randomly divided into two groups: one group (treatment group, n=31) was treated with the traditional Chinese medicine composition of this invention; the other group (control group, n=30) was treated with Xuanfei Zhike Mixture. There were no statistically significant differences between the two groups in terms of age, gender, course of disease, and other general information. P >0.05).
[0069] 1. Diagnostic criteria Referring to the diagnosis of wind-cough, intractable cough, and other diseases in "Internal Medicine of Traditional Chinese Medicine," "New Insights into Medicine," and related guidelines, and based on the syndrome differentiation of residual pathogenic factors transforming into turbidity and lung qi obstruction, the diagnostic criteria are as follows: (1) Main symptoms: At least two of the following symptoms are present, and the total score is ≥3 points: cough Coughing up phlegm (sticky phlegm) Itchy throat (2) Secondary symptoms: At least one of the following symptoms is present: Nasal congestion Chest tightness Decreased sense of smell (3) Tongue and pulse: The tongue must be pale red or dark red, with a yellow or white greasy coating; and the pulse must be wiry and slippery or thin and slippery.
[0070] The above (1), (2), and (3) must be met simultaneously for a diagnosis to be confirmed.
[0071] The severity grading of symptoms of residual pathogenic factors transforming into turbidity and obstructing lung qi is shown in Table 1 below.
[0072] Table 1. Severity Grading of Symptoms of Residual Evil Transforming into Turbidity and Lung Qi Obstruction Syndrome
[0073] 2. Experimental methods and observation indicators The traditional Chinese medicine treatment group was given the decoction of the traditional Chinese medicine composition of Example 2 of the present invention, with a dose of 200ml, one dose per day, taken twice a day, morning and evening; the treatment continued for 8 weeks.
[0074] The control group was given a lung-clearing and cough-relieving compound, one vial twice a day, for 8 weeks.
[0075] 3. Comprehensive evaluation of therapeutic effects The clinical research of new traditional Chinese medicine drugs should be conducted in accordance with the following four levels: 2) Clinical control: Cough and accompanying symptoms disappear or basically disappear after treatment, and the score decreases by ≥95% compared with before treatment; 3) Significant effect: After treatment, cough and accompanying symptoms are significantly improved, and the score is reduced by more than 70% compared with before treatment; 4) Effective: Cough and accompanying symptoms improved after treatment, and the score decreased by 30% to 69% compared with before treatment; Ineffective: Cough and accompanying symptoms do not improve significantly or worsen, and the score is reduced by less than 30% compared with before treatment.
[0076] 4. Results Safety assessment Throughout the treatment and follow-up period, no significant adverse reactions were reported in either the treatment or control group. Vital signs remained stable, and laboratory tests for liver and kidney function showed no abnormalities. The results indicate that both treatment regimens have good safety profiles.
[0077] Statistical methods: Wilcoxon signed-rank test was used for comparisons within groups before and after treatment, and Mann-Whitney U test was used for comparisons between groups.
[0078] The results of the symptomatic changes are shown in Table 2 below: Table 2. Changes in TCM symptom scores after drug treatment in the two groups.
[0079] Note: Comparison before and after treatment within the same group, * P <0.05,** P <0.01; compared with the control group, # P <0.05, ## P <0.01.
[0080] As shown in Table 2, after 8 weeks of medication, the scores of all symptoms of lung qi obstruction syndrome in the treatment group were significantly lower than before treatment. P <0.01); In the control group, symptoms of cough, chest tightness, and itchy throat were significantly improved compared with those before treatment ( P <0.01), while nasal congestion, coughing, and decreased sense of smell showed no significant improvement (P >0.05). The treatment group showed a significant difference compared to the control group in improving the above symptom scores ( P <0.01 or P <0.05).
[0081] The overall efficacy evaluation is shown in Table 3 below.
[0082] Table 3 Comparison of overall therapeutic effects between the two groups
[0083] As shown in Table 3, after 8 weeks of treatment, in the treatment group, 12 cases were cured, 16 cases showed significant improvement, 3 cases showed improvement, and 0 cases were ineffective, with a total effective rate of 100%; in the control group, 1 case was cured, 5 cases showed significant improvement, 19 cases showed improvement, and 5 cases were ineffective, with a total effective rate of 83.3%. The difference between the two groups was statistically significant. P <0.01).
[0084] The above clinical application results show that the traditional Chinese medicine composition provided by the present invention has the effects of clearing the lungs and dispelling pathogens, reducing phlegm and eliminating turbidity, and has a good therapeutic effect on chronic refractory cough.
[0085] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.
Claims
1. A traditional Chinese medicine composition for treating chronic refractory cough, characterized in that, The ingredients include the following components in the indicated weight proportions: 10-20 parts Belamcanda chinensis, 4-8 parts processed Ephedra sinica, 2-5 parts Asarum heterotropoides, 10-20 parts Pinellia ternata with bamboo sap, 6-12 parts raw Glycyrrhiza uralensis, 10-20 parts Bupleurum chinense, 10-20 parts stir-fried Scutellaria baicalensis, 6-12 parts Citrus aurantium, 6-12 parts Platycodon grandiflorus, 10-20 parts processed Perilla frutescens, 6-12 parts Prunus armeniaca, 30-50 parts Fagopyrum dibotrys, 9-15 parts Phyllanthus urinaria, 9-15 parts Phyllanthus urinaria, and 20-40 parts Trichosanthes kirilowii peel.
2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The ingredients include the following components in the indicated weight proportions: 15 parts Belamcanda chinensis, 6 parts processed Ephedra sinica, 3 parts Asarum heterotropoides, 15 parts Pinellia ternata with bamboo sap, 9 parts raw Glycyrrhiza uralensis, 15 parts Bupleurum chinense, 15 parts stir-fried Scutellaria baicalensis, 9 parts Citrus aurantium, 9 parts Platycodon grandiflorus, 15 parts processed Perilla frutescens, 9 parts Prunus armeniaca, 40 parts Fagopyrum dibotrys, 12 parts Phyllanthus urinaria, 12 parts Phyllanthus urinaria, and 30 parts Trichosanthes kirilowii peel.
3. A method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The preparation method is water extraction.
4. The preparation method according to claim 3, characterized in that, The preparation method is as follows: take each component raw material, add water and decoct, filter, add an appropriate amount of water to the medicinal material, decoct again, filter, and combine the two filtrates to obtain the final product.
5. The preparation method according to claim 4, characterized in that, It also includes one or more of the following features: (a) The decocting time is 25-35 min; (b) The decoction time is 15-25 min.
6. Use of the traditional Chinese medicine composition as described in claim 1 or 2, or the traditional Chinese medicine composition prepared by the preparation method as described in any one of claims 3 to 5, in the preparation of a medicament for treating chronic refractory cough.
7. The use as described in claim 6, characterized in that, The chronic refractory cough conforms to the syndrome of residual pathogenic factors transforming into turbidity and obstruction of lung qi in traditional Chinese medicine.
8. A traditional Chinese medicine preparation comprising the traditional Chinese medicine composition as described in claim 1 or 2, or the traditional Chinese medicine composition prepared by the preparation method as described in any one of claims 3 to 5.
9. The traditional Chinese medicine preparation as described in claim 8, characterized in that, The traditional Chinese medicine preparations mentioned are oral preparations, including solutions, granules, pills, tablets, capsules, syrups, and sprays.