A traditional Chinese medicine composition, preparation and application for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome.

Abstract

This invention relates to the field of pharmaceutical technology for treating laryngopharyngeal reflux disease, specifically to a traditional Chinese medicine composition, preparation, and application for treating lung-stomach disharmony syndrome in laryngopharyngeal reflux disease. The active ingredients of the traditional Chinese medicine composition, by weight, include the following: 8 parts of Belamcanda chinensis, 10 parts of Terminalia chebula, 8 parts of Oroxylum indicum, 6 parts of stir-fried Coptis chinensis, 3 parts of processed Evodia rutaecarpa, 9 parts of ginger-processed Pinellia ternata, 15 parts of processed Magnolia officinalis, 20 parts of white snail shell, 20 parts of Ganoderma lucidum, and 30 parts of Serissa japonica. The beneficial effects of this invention are: the traditional Chinese medicine composition of this invention can effectively treat lung-stomach disharmony syndrome in laryngopharyngeal reflux disease, and has high safety with no obvious adverse reactions, and can improve some of the patient's throat symptoms and TCM syndromes.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology for treating laryngopharyngeal reflux disease, and more specifically, to a traditional Chinese medicine composition, preparation, and application for treating lung-stomach disharmony syndrome in laryngopharyngeal reflux disease. Background Technology

[0002] Laryngopharyngeal reflux disease (LPRD) is a throat discomfort caused by the reflux of stomach contents, gastric acid, pepsin, and conjugated bile acids into the upper respiratory tract and digestive region. It includes a range of symptoms, not limited to cough, hoarseness, a feeling of a lump in the throat, sore throat, dysphagia, postnasal drip, and chronic repetitive throat clearing. Many mucosal changes are associated with LPRD, including supraglottic edema and erythema, posterior pharyngeal cobblestones, vocal cord ulcers, medial muscle wall edema, and vocal cord granulomas. Disease progression can lead to ulcerative diseases, granulomas, subglottic stenosis, and laryngeal cancer. Laryngopharyngeal reflux (LPR) is the process of stomach contents refluxing into the larynx and pharynx. There is an association between LPRD and extraesophageal syndromes of gastroesophageal reflux disease (GERD). A growing number of gastroenterologists, pulmonologists, and otolaryngologists are paying increasing attention to symptoms of throat discomfort. Current data indicates that up to 60% of GERD patients experience throat symptoms, potentially increasing the risk of laryngeal cancer.

[0003] The pathogenesis of laryngopharyngeal reflux disease (LDR) involves the reflux of gastrointestinal contents (such as pepsin, bile salts, and other gastrointestinal proteins) into the mucosa of the upper respiratory and digestive tract. In particular, the deposition of pepsin can lead to mucosal damage, inflammation, mucus dryness, epithelial thickening, and microtrauma. Mucosal irritation causes mucus production and dehydration; the accumulation of thick mucus induces postnasal drip, globus hystericus, throat clearing, dysphagia, and coughing. Depending on the patient's mucosal sensitivity, both acute and chronic LDR patients may experience varying degrees of symptoms.

[0004] The reflux theory posits that laryngopharyngeal reflux disease (LDR) is caused by the microaspiration of acids, bile acids, and pepsin. These acids, bile acids, and pepsin can directly damage the larynx and cause symptoms. The finding of elevated levels of salivary pepsin and bile acids in patients with LDR supports this. Furthermore, the reflex theory suggests that the reflux of acidic gastric contents from the distal esophagus stimulates the vagus nerve, thereby inducing laryngeal symptoms. LDR may or may not be accompanied by typical symptoms of gastroesophageal disease. Currently, three mechanisms explain this. First, the direct action of acidic gastric contents on the more sensitive pharynx and larynx causes irritation. Second, the reflux of gastric contents into the distal esophagus stimulates the vagus nerve reflex, leading to a chronic cough, which in turn induces LDR symptoms. Finally, the reflux of non-acidic gastric contents can also cause laryngeal damage. Impairment of the main mechanisms defending against reflux is likely the primary cause of acid reflux. Theoretically, weakened esophageal motility and LES and UES pressures could lead to an increase in esophageopharyngeal reflux events. Furthermore, laryngopharyngeal reflux disease (LRPD) is suspected to be associated with many prevalent diseases, such as Parkinson's disease, pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), and systemic sclerosis (SSc). Impairment of respiratory, digestive, or swallowing physiology associated with these diseases may be linked to an increased risk of reflux. Similarly, taking certain medications such as benzodiazepines, antidepressants, anticholinergics, calcium channel blockers, lidocaine, and prostaglandins can increase the risk of LRPD.

[0005] Due to the lack of definitive and effective treatment options, proton pump inhibitors (PPIs) are widely used in the real world to treat laryngopharyngeal reflux disease (LDR). Empirical use of high-dose PPIs is still recommended for suspected LDR patients. Therefore, although PPI therapy is currently a popular first-line treatment for LDR, it carries potential risks. Long-term PPI use has long been suspected of being associated with adverse events such as altered mineral and vitamin absorption, fractures, orthopedic injuries, acute coronary syndrome, colitis, increased risk of infection, and increased risk of death. Furthermore, the over-prescription of PPIs, especially in elderly patients, has a significant impact on healthcare costs, making reflux one of the most expensive diseases to manage. Therefore, for LDR, we need to prioritize traditional Chinese medicine (TCM) treatments, which offer safety and cost-effectiveness. In recent years, numerous studies have shown that TCM treatment based on syndrome differentiation is significantly effective in treating LDR, eliminating and alleviating clinical symptoms to some extent and reducing the side effects of PPIs. Therefore, TCM treatment can be considered for LDR.

[0006] Traditional Chinese medicine (TCM) has a unique understanding and therapeutic effect on laryngopharyngeal reflux disease (LHDR). While there is no directly corresponding disease name for LHDR, TCM often refers to it as "pharyngeal-stomach related disease" or "gastric-pharyngeal combined disease," believing that pharyngeal diseases are often inseparable from stomach lesions. Based on its clinical manifestations, it is often classified as "esophageal obstruction" or "globus hystericus." If gastrointestinal symptoms are significant, it can also be treated according to diseases such as "acid reflux," "heartburn," "gastric fullness," or "stomach pain." The earliest relevant discussion of LHDR in TCM is found in the *Synopsis of Prescriptions of the Golden Chamber* (Jin Gui Yao Lue), specifically in the section on "Miscellaneous Diseases of Women," which states: "For women, if there is a lump in the throat, the Banxia Houpu Decoction is the main treatment." This is generally considered the earliest record of the treatment of "globus hystericus." The term "globus hystericus" first appeared in the Song Dynasty text *Ren Zhai Zhi Zhi Fang* (Ren Zhai's Direct Prescriptions), describing its clinical manifestations as a feeling of obstruction in the throat, unable to be vomited or swallowed, accompanied by fullness in the hypochondrium, coughing, vomiting, a white and moist or white and slippery tongue coating, and a wiry and slow or wiry and slippery pulse. Furthermore, Traditional Chinese Medicine (TCM) believes that the esophagus, the passageway through which the stomach receives food, is governed by the stomach's Qi (vital energy). The stomach is responsible for digestion and absorption, and the ascending and descending functions of the middle Jiao (middle burner) allow for the unimpeded transformation and distribution of dietary essence and the smooth downward flow of waste. If the ascending and descending functions of the middle Jiao are disrupted, Qi stagnation occurs, and the ascending and descending functions become disordered, acidic fluid can rise to the throat, causing a series of throat discomforts, including cough, esophageal obstruction, and hoarseness. If stomach contents enter the esophagus and are aspirated into the lungs, the acidic contents can cause damaging infections; or, due to reflux, the esophagus may be stimulated, leading to secondary bronchoconstriction regulated by nerves, resulting in choking, wheezing attacks of bronchitis, aspiration pneumonia, or even suffocation. Li Dongyuan, one of the four great masters of the Jin-Yuan period, believed that acid reflux and vomiting were caused by cold in nature, arguing that "miscellaneous diseases of the heart, with turbid qi failing to descend, lead to abdominal distension; how can cold medicine cure this?" Danxi, on the other hand, believed that "acid reflux is caused by damp heat accumulating in the liver and then lurking between the lungs and stomach," and further stated that "the *Suwen* speaks of heat, referring to the root cause; Dongyuan speaks of cold, referring to the branch." In treatment, he advocated using Coptis chinensis as the chief herb, supplemented by stir-fried Evodia rutaecarpa. The lungs are the organ of purification and cleansing; they cannot tolerate even a single substance. If stomach contents accidentally enter the airways, it leads to impaired lung qi circulation, causing it to rise instead of descend, or even phlegm obstructing the lungs, making the pathogenesis of this disease more complex. In such cases, treatment should focus on descending lung qi and harmonizing the stomach, clearing the lungs and stomach, or even strengthening the spleen and benefiting the lungs, tonifying the earth to generate metal, and invigorating qi and promoting yang to improve the therapeutic effect.

[0007] The etiology, pathogenesis, and syndrome differentiation of laryngopharyngeal reflux disease can be roughly summarized as follows: ① External pathogens invading the stomach: Cold, summer heat, dampness, and turbidity invade the stomach, causing it to lose its descending function. Gastric juices rise upwards along with stomach qi to the diaphragm, as stated in the *Suwen* (Plain Questions) chapter "On Pain": "When cold qi invades the intestines and stomach, it causes qi to rise upwards." The *Suwen* chapter "On the Essential Principles of Medicine" states: "When Jueyin prevails... the stomach and diaphragm transform from cold to heat, causing pain in the epigastrium and heart... obstruction of the diaphragm and throat... When Shaoyang prevails, heat invades the stomach, causing restlessness, heart pain... vomiting acid and excessive hunger... When Taiyin prevails, internal heat stagnates... heart pain and heat retention... internal dampness stagnates." When dampness accumulates in the stomach, it generates heat, which transforms into wood, leading to acid reflux. ② Improper diet: This can cause food stagnation in the stomach and diaphragm, causing stomach qi to rise upwards, overflowing into the throat and injuring the throat. Overeating leads to stomach discomfort and indigestion. If one indulges in fried, spicy, sweet, or greasy foods, it can lead to the accumulation of heat in the stomach due to the rich and greasy nature of these foods. Alternatively, hot foods can deplete the spleen and stomach's fluids, causing dryness and deficiency heat. ③ Emotional imbalance: Worry and distress can cause liver qi stagnation, which then attacks the stomach, leading to acid reflux into the throat. Excessive mental strain can damage the spleen's blood, impairing its function and causing the spleen to fail to properly digest food, resulting in the throat lacking nourishment. ④ Constitutional differences: If a patient has a history of spleen and stomach deficiency and insufficient chest yang, external pathogens can further damage the spleen and stomach, causing dysfunction in their ascending and descending functions, obstructing the flow of qi, leading to upward flow of turbid qi, belching, acid reflux, and throat discomfort. Furthermore, disharmony of stomach qi can cause upward flow of cold qi into the chest and diaphragm, transforming into heat, resulting in burning sensation in the epigastrium and diaphragm. The chest is highly susceptible to pathogens because it is open and vulnerable; once the yang qi in the chest is weak, cold pathogens can carry phlegm and saliva upwards and accumulate in the throat. Therefore, impaired qi flow in the chest leads to throat discomfort.

[0008] In summary, laryngopharyngeal reflux disease is located in the upper abdomen and throat. "Acid reflux is characterized by belching in the throat, and the disease is located in the highest part of the upper abdomen." "In the middle abdomen and stomach, there is often nausea and vomiting, and what is vomited is all sour." "On occasional vomiting may produce sour, bitter, or other unpleasant tastes, which are the result of accumulated phlegm and fluid in the intestines and stomach." This suggests that such refluxed material can invade the throat and sensory organs, causing a series of throat discomforts.

[0009] Currently, there is limited research on the TCM syndrome differentiation of laryngopharyngeal reflux disease (LDR). Li Yunying differentiates and treats LDR based on five syndrome types: liver qi stagnation, liver and stomach heat stagnation, qi stagnation and phlegm obstruction, middle jiao deficiency and qi reversal, and blood stasis obstructing the collaterals. Zhong Xiuting et al. investigated 195 LDR patients and summarized seven common LDR syndrome types. In her observation group, liver-stomach disharmony and liver qi stagnation and spleen deficiency were the most common, followed by spleen and stomach weakness, liver and stomach heat stagnation, phlegm and qi obstruction, stomach yin deficiency, and qi stagnation and blood stasis. Li Ping et al. summarized the TCM syndrome types of LDR into five categories: liver-spleen disharmony, qi stagnation and phlegm obstruction, liver fire invading the stomach, dampness obstructing the middle jiao, lung-stomach disharmony, and stomach yin deficiency. Cai Yanwen et al., in clinical practice, summarized three TCM syndrome types of LDR: qi stagnation and phlegm accumulation, lung-stomach damp-heat, and lung-stomach yin deficiency. Liu Tieling and others also summarized three syndrome types in their clinical observations: Qi stagnation and phlegm accumulation, damp-heat in the lungs and stomach, and Yin deficiency in the lungs and stomach.

[0010] Here are some common syndrome types: ① Phlegm and Qi obstruction: Clinical manifestations include a foreign body sensation in the throat, chest tightness, abdominal distension, belching, occasional acid reflux, and heartburn. The severity and onset of the condition are often related to emotions. Treatment often focuses on soothing the liver and regulating Qi, resolving phlegm and lowering Qi. A modified Si Ni San combined with Ban Xia Hou Po Tang can be used. For those with a pronounced foreign body sensation in the throat, pharyngeal follicular hyperplasia is common. For those with cough, Belamcanda chinensis, Oroxylum indicum, and Platycodon grandiflorus can be added. For dry throat with phlegm, Ophiopogon japonicus and Fritillaria thunbergii can be added. For excessive phlegm, Radish seed and Fritillaria thunbergii can be added. ② Spleen and stomach deficiency: Clinical manifestations include a foreign body sensation in the throat, hoarseness after slight exertion or excessive vocalization, a sallow and dull complexion, abdominal distension, poor appetite, belching, acid reflux, occasional heartburn, loose or scanty stools, and a thin white tongue coating. Treatment focuses on strengthening the spleen and replenishing Qi, soothing the liver and harmonizing the stomach. This type of patient is mostly obese. Modern medicine believes that increased abdominal pressure due to obesity is one of the main causes of gastroesophageal reflux. From the perspective of traditional Chinese medicine, the spleen governs the muscles, and spleen deficiency leads to muscle weakness or flaccidity. ③ Spleen and stomach damp-heat, clinical manifestations: foreign body sensation in the throat, even burning sensation, abdominal distension, dry mouth and bitter taste, chest and abdominal discomfort, occasional heartburn and belching, incomplete bowel movements or constipation, and dark yellow urine. Treatment: mainly clearing heat and dampness, soothing the liver and harmonizing the stomach. Banxia Xiexin Decoction combined with Si Ni San can be used with modifications. If liver qi is significantly invading the stomach, there will be frequent belching, distending discomfort in the hypochondriac region; if there is eye discharge in the morning, mulberry leaves and chrysanthemum can be added; if there is incomplete bowel movements or significant constipation, the dosage of Polygonum cuspidatum and dandelion can be increased to clear heat, dry dampness and promote bowel movement. ④ Lung and Stomach Fluid Deficiency: Symptoms include burning sensation in the chest and epigastrium, frequent heartburn or belching, dry throat, dry and bitter mouth, excessive hunger and thirst, dry or hard stools, red tongue with little coating, and a thready and rapid pulse. This is caused by external pathogenic heat that depletes the fluids of the diaphragm and stomach. Emotional distress leads to qi stagnation and fire, further scorching stomach yin, resulting in insufficient fluids and burning pain in the chest and epigastrium. Treatment should focus on nourishing yin, replenishing fluids, and soothing the throat. Chinese herbal medicines such as *Oroxylum indicum*, *Adenophora stricta*, *Ophiopogon japonicus*, *Rehmannia glutinosa*, *Polygonatum odoratum*, *Dendrobium nobile*, and *Phragmites communis* can be used to nourish the lungs and stomach, soothe the throat, and moisten the throat. *Paeonia suffruticosa*, *Coptis chinensis*, and *Bamboo shavings* can clear heat, harmonize the stomach, and suppress acid reflux.

[0011] III. Understanding Laryngopharyngeal Reflux Disease Due to Lung-Stomach Disharmony

[0012] He Mengyao stated, "Food enters the stomach, and the spleen, responsible for transporting the essence of Qi, circulates it throughout the body daily, but it first ascends to the lungs, benefiting them first. This is the principle of 'spleen earth generating lung metal.' When the lungs receive the benefits of the spleen, their Qi becomes stronger, transforming water and descending to nourish all the meridians." From the perspective of the Five Elements, the lungs belong to Metal, and the spleen and stomach belong to Earth; Earth generates Metal. The lungs reside in the upper Jiao (upper burner), while the spleen and stomach reside in the middle Jiao; the lungs govern descending, while the spleen governs ascending. The lungs regulate water metabolism, while the spleen governs the transformation and transportation of fluids. The lungs and spleen / stomach are mutually generative. The spleen and stomach are the mother organs of the lungs; the lungs govern Qi, and the spleen benefits Qi. Thus, the Qi of the lungs ultimately originates from the spleen—the essence of food and water produced by the spleen and stomach—which first reaches and nourishes the lungs. Therefore, most dysfunctions of the spleen and stomach, affecting their ascending, descending, or transforming functions, will first impact the physiological and pathological state of the lungs. The lungs and stomach are mother and child organs, physiologically interdependent and mutually supportive. The lungs govern all qi, and all the five viscera and six bowels rely on lung qi to maintain their normal physiological functions. Simultaneously, the essence of the body's organs is replenished through the lungs' dispersing and dispersing function, including the stomach, which is also regulated by lung qi for digestion and transformation. Therefore, abundant lung qi replenishes and strengthens stomach qi, while deficient lung qi weakens stomach qi. This illustrates the close relationship between the lungs and stomach. Numerous clinical facts prove this close correlation, and the *Suwen* (Plain Questions) chapter on cough describes, "If a spleen cough persists, the stomach will also be affected. The symptoms of a stomach cough are coughing and vomiting; severe vomiting may even cause worms to expel." This is due to the lungs being affected by pathogenic factors, mistreatment, or improper treatment, leading to the pathogenic factors lodging in the stomach, causing stomach qi to rise and resulting in both coughing and vomiting. This type of "stomach cough" is indeed frequently seen clinically. However, when lung-tonifying herbs are added to stomach-tonifying prescriptions, the above symptoms gradually disappear. This is not an isolated or accidental phenomenon. Because the lung and stomach meridians are connected, and the Stomach Meridian of Foot Yangming and the Lung Meridian of Hand Taiyin meet at the throat, stomach ailments also manifest as throat discomfort. This means the root cause is in the stomach, but the symptoms manifest in the lungs; both are related. Several other similar phenomena of stomach ailments and lung-related issues can be listed. Many physicians throughout history have been adept at treating the stomach by addressing the lungs. Chen Xiuyuan of the Qing Dynasty is a prime example; his "Lily and Black Root Decoction" for treating stomach pain has been consistently effective. Chen Xiuyuan himself stated, "Lily, being white, enters the lungs; the lungs govern Qi, and when lung Qi descends, all Qi is harmonized." Therefore, treating stomach ailments by regulating lung Qi is not without basis. For patients with laryngopharyngeal reflux disease, treatment can begin with clearing the lungs, calming the stomach, and relieving throat discomfort.

[0013] Preliminary clinical observations have revealed that the incidence of reflux disease is increasing year by year due to changes in people's lifestyles and dietary structures, and the incidence of laryngopharyngeal reflux disease is also increasing accordingly. The *Suwen* (Plain Questions) states, "When discussing the yin and yang of the human body's organs, the viscera are yin, and the stomach is yang..." The spleen is the viscera, and the stomach is the stomach; therefore, the spleen is yin earth, and the stomach is yang earth. The stomach, being yang earth, has a preference for moisture and aversion to dryness; it is also known as dry earth, or Yangming dry earth. It thrives on yin, and sufficient fluids in the stomach are essential for digesting food and maintaining its downward flow. As a body of deficiency, the lungs prefer moisture. If the diet is uncontrolled and unbalanced, with a preference for spicy and stimulating foods, it will scorch the lungs and stomach, depleting their fluids and leading to upward flaring of deficiency fire. This depletes the qi of the lungs and stomach, causing the lungs to lose their purifying function, resulting in the upward reversal of lung qi, which can then develop into reflux, cough, or itchy throat. The pharynx is associated with the lungs, and lung-stomach disharmony is extremely common in southern regions. The overall pathogenesis of laryngopharyngeal reflux disease (LDR) can be summarized as follows: "When the lungs and stomach are not in harmony, the stomach qi fails to descend, leading to internal heat, which, along with stomach contents, ascends to the lungs, causing symptoms such as a foreign body sensation in the throat and chronic cough." LDR is located in the pharynx and is closely related to the lungs and stomach. In southern regions, its pathogenesis is often attributed to deficiency heat, fluid depletion, and dampness obstruction.

[0014] Chinese invention patent (publication number: CN114177269B, publication date: March 21, 2023) discloses a traditional Chinese medicine composition for treating reflux laryngitis. The composition is made from the following raw materials in parts by weight: 10-14 parts of Inula japonica, 13-17 parts of calcined hematite, 10-14 parts of Pinellia ternata, 10-14 parts of Magnolia officinalis, 13-17 parts of Poria cocos, 10-14 parts of Perilla frutescens leaf, 1-5 parts of fresh ginger, 7-11 parts of licorice root, 7-11 parts of Platycodon grandiflorus, 7-11 parts of Belamcanda chinensis, 1-5 parts of Coptis chinensis, 1-5 parts of Evodia rutaecarpa, 28-32 parts of calcined oyster shell, 18-22 parts of cuttlebone, and 13-17 parts of Clematis chinensis. This invention targets laryngeal reflux disease due to qi stagnation and phlegm obstruction, and its symptom improvement and clinical efficacy are superior to those of rabeprazole sodium enteric-coated capsules for treating reflux laryngitis. Summary of the Invention

[0015] This invention addresses the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome. This composition effectively treats laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, exhibits high safety with no significant adverse reactions, and can improve some of the patient's throat symptoms and TCM syndromes.

[0016] To achieve the above objectives, the present invention adopts the following technical solution:

[0017] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the traditional Chinese medicine composition include the following ingredients in parts by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of stir-fried Coptis chinensis, 1-5 parts of processed Evodia rutaecarpa, 5-15 parts of ginger-processed Pinellia ternata, 10-20 parts of processed Magnolia officinalis, 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, and 25-35 parts of Serissa japonica.

[0018] Preferably, the active ingredients of the traditional Chinese medicine composition include the following ingredients by weight: 8 parts of Belamcanda chinensis, 10 parts of Terminalia chebula, 8 parts of Oroxylum indicum, 6 parts of Coptis chinensis (fried), 3 parts of Evodia rutaecarpa (processed), 9 parts of Pinellia ternata (processed), 15 parts of Magnolia officinalis (processed), 20 parts of white snail shell, 20 parts of Ganoderma lucidum, and 30 parts of Serissa japonica.

[0019] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition further include the following raw materials in parts by weight:

[0020] Platycodon grandiflorus 2-10 parts, Corydalis yanhusuo 5-15 parts;

[0021] Alternatively, stir-fry 15-25 parts of Atractylodes macrocephala, 10-20 parts of Poria cocos, and 5-15 parts of Dolichos lablab;

[0022] Alternatively, use 2-10 parts dried tangerine peel and 2-10 parts cardamom.

[0023] Alternatively, stir-fry 15-25 parts chicken gizzard, 10-20 parts malt, and 10-20 parts rice sprouts;

[0024] Alternatively, 15-25 parts of calcined oyster shell and 15-25 parts of calcined oyster shell.

[0025] Preferably, the active ingredient raw materials of the traditional Chinese medicine composition further include the following raw materials in parts by weight:

[0026] Platycodon grandiflorus 6 parts, Corydalis yanhusuo 9 parts;

[0027] Alternatively, stir-fry 20 parts of Atractylodes macrocephala, 15 parts of Poria cocos, and 9 parts of white hyacinth bean;

[0028] Alternatively, use 6 parts dried tangerine peel and 6 parts cardamom.

[0029] Alternatively, stir-fry 20 parts chicken gizzard, 15 parts malt, and 15 parts rice sprouts.

[0030] Alternatively, 20 parts of calcined oyster shell and 20 parts of calcined oyster shell.

[0031] Preferably, the traditional Chinese medicine composition further includes appropriate amounts of other traditional Chinese medicine extracts and / or other raw materials.

[0032] Furthermore, the present invention also discloses a traditional Chinese medicine composition preparation for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the traditional Chinese medicine composition preparation includes the aforementioned traditional Chinese medicine composition and / or pharmaceutical excipients and / or food additives.

[0033] Preferably, the traditional Chinese medicine composition is in the form of tablets, chewable tablets, powders, granules, powders, capsules, ointments, pills, or liquid preparations.

[0034] Furthermore, the present invention also discloses the application of the aforementioned traditional Chinese medicine composition and traditional Chinese medicine composition preparation in the preparation of a medicine for treating pharyngeal reflux disease with lung-stomach disharmony syndrome.

[0035] The principle of the formulation design of this invention:

[0036] This invention uses Terminalia chebula and Oroxylum indicum as the principal herbs in its traditional Chinese medicine composition. The combined effect of these two herbs significantly enhances their lung-moistening and throat-soothing properties. Belamcanda chinensis and Serissa japonica, one cold and one hot, further strengthen the efficacy of the principal herbs, serving as assistant herbs in the formula. Prepared Evodia rutaecarpa counteracts the effects of stir-fried Coptis chinensis to clear and reduce deficiency fire; ginger-processed Pinellia ternata and prepared Magnolia officinalis dry dampness, resolve phlegm, relieve nausea and vomiting, and dissipate lumps and nodules. White snail shell is added to resolve dampness, stop reflux, harmonize the stomach, and relieve pain. Finally, Ganoderma lucidum is added to nourish qi and blood, calm the mind, and strengthen the lungs and stomach. The entire formula works synergistically to soothe the throat, reduce stomach upset, moisten the lungs, and clear heat, allowing the qi of the lungs and stomach to flow smoothly. This eliminates deficiency fire, alleviates reflux, and relieves throat discomfort. This is a good supplement and adjustment to the treatment of laryngopharyngeal reflux disease with proton pump inhibitors alone.

[0037] Belamcanda chinensis enters the lung and liver meridians. It is bitter and cold in nature and slightly toxic. It has the functions of clearing heat and detoxifying, reducing fire and eliminating phlegm, dispersing blood and dissipating nodules. It can treat diseases such as sore throat, wheezing and shortness of breath, phlegm accumulation and scrofula, amenorrhea, and acid reflux.

[0038] The western green fruit enters the lung and large intestine meridians. It is neutral in nature and has a bitter, slightly sweet and astringent taste. It is mainly used to clear heat, promote body fluid production, soothe the throat, and detoxify.

[0039] The wood butterfly enters the lung, liver, and stomach meridians. It has a slightly bitter and sweet taste and a slightly cold nature. It has the effects of relieving sore throat and moistening the lungs; soothing the liver and harmonizing the stomach; and promoting wound healing and tissue regeneration. It can be used to treat sore throat, hoarseness, cough, and other symptoms.

[0040] Coptis chinensis enters the heart, liver, stomach, and large intestine meridians. It is bitter and cold in nature and has the functions of purging fire, drying dampness, detoxifying, and treating heat toxicity, typhoid fever with fullness and vomiting, vomiting, nosebleeds, whooping cough, sore throat, and canker sores.

[0041] Evodia rutaecarpa enters the liver, spleen, stomach, and kidney meridians. It is pungent, bitter, and hot in nature, and slightly toxic. Its main functions are to dispel cold and relieve pain, suppress nausea and vomiting, and tonify yang to stop diarrhea. It can be used for vomiting and acid regurgitation, and early morning diarrhea. Its use in combination with Coptis chinensis is a classic example of a counteracting effect.

[0042] Pinellia ternata enters the spleen, stomach, and lung meridians. It is pungent and warm in nature and is toxic. It can dry dampness and resolve phlegm, relieve nausea and vomiting, and dissipate lumps and nodules. It is used in the famous ancient prescription "Pinellia and Magnolia Bark Decoction" by Zhang Zhongjing. It is an important medicine for treating phlegm and qi stagnation and plum pit qi. It can improve symptoms such as cough, asthma, phlegm accumulation, sore throat, vomiting and nausea, and fullness and discomfort in the middle jiao.

[0043] Magnolia officinalis enters the spleen, stomach, lung, and large intestine meridians. It is bitter, pungent, and warm in nature. It is mainly used to dry dampness and eliminate phlegm, lower qi and relieve fullness. It is used for symptoms such as cough with phlegm, dampness stagnation injuring the middle jiao, epigastric fullness and vomiting, food stagnation and qi stagnation, and abdominal distension.

[0044] White snail shells are associated with the lung, heart, and stomach meridians. They are sweet and bland in taste and neutral in nature. They can resolve phlegm, disperse nodules, relieve pain, and promote wound healing. They are used to treat symptoms such as cough with phlegm due to heat, nausea, stomach pain, and acid reflux.

[0045] Reishi mushroom enters the heart, lung, liver, and kidney meridians. It is sweet and neutral in nature. Its functions and indications include tonifying qi and calming the mind, relieving cough and asthma, and is used for palpitations, shortness of breath, and consumptive cough and asthma.

[0046] June snow enters the liver and spleen meridians. It has a bland and slightly spicy taste and is cool in nature. It is mainly used to dispel wind and release the exterior, clear heat and promote diuresis, and relax muscles and tendons. It can be used for colds, coughs, acute tonsillitis, pharyngitis, and other symptoms.

[0047] Pharmacological principles of the single-herb formula in this invention:

[0048] Belamcanda chinensis: Decoctions or infusions of Belamcanda chinensis have inhibitory or delaying effects on certain viruses causing exogenous diseases and throat ailments in vitro, and also inhibit mucosal exudation. Oral or injectable alcohol or water extracts of Belamcanda chinensis can promote saliva secretion in rabbits. In addition, it has estrogen-like effects.

[0049] Terminalia chebula: Terminalia chebula contains 20%–40% tannins, with chebulic acid, chebulic acid, tannin, protochebulic acid, ellagic acid, and gallic acid as the main components. The "National Compendium of Chinese Herbal Medicines" records that 2–3 Terminalia chebula fruits are remarkably effective in treating sore throat and swelling. The specific method involves grinding the Terminalia chebula fruits into juice, swallowing it slowly at room temperature, and allowing it to remain in the throat for as long as possible to achieve the desired effect.

[0050] Oroxylum indicum: The bark and seeds of Oroxylum indicum contain baicalin, which has anti-inflammatory and anti-immune abnormality effects, as well as diuretic, bile duct beneficial, cholesterol-lowering, and atherosclerotic effects. In addition to baicalin, Oroxylum indicum also contains components such as scutellarin, which have a synergistic and toxicity-reducing effect on chemotherapy for nasopharyngeal carcinoma cells.

[0051] Fried Coptis chinensis: Coptis chinensis has broad-spectrum antibacterial effects. Berberine has inhibitory effects on various bacteria and viruses. Low concentrations inhibit bacteria, while high concentrations kill bacteria. Berberine has inhibitory effects on both acute and chronic inflammation. Coptis chinensis and berberine enhance the phagocytic function of leukocytes, and berberine reduces the production of inflammatory mediators.

[0052] Evodia rutaecarpa: Decoctions have strong inhibitory effects on Vibrio cholerae and Epidermophyton floccosum. Large amounts of Evodia rutaecarpa have a stimulating effect on the central nervous system and can cause visual impairment and illusions. The alcoholic extract of Evodia rutaecarpa from Japan has analgesic effects, with analgesic potency roughly equivalent to antipyrine or aminopyrine. Its alkaloids and hydrochloride salts have sedative-hypnotic effects on mice.

[0053] Pinellia ternata: Decoctions of raw Pinellia ternata, ginger-processed Pinellia ternata, ginger-soaked Pinellia ternata, and alum-processed Pinellia ternata have a significant antitussive effect on coughs, which can last for more than 5 hours. It also inhibits glandular secretion and has a certain antiemetic effect.

[0054] Magnolia officinalis: The decoction of Magnolia officinalis has antibacterial effects against various bacteria, making it one of the most potent antibacterial traditional Chinese medicines. In addition to its antibacterial effects, the decoction of Magnolia officinalis can stimulate gastrointestinal motility at low concentrations, while exhibiting an inhibitory effect at high concentrations.

[0055] White snail shell: The main component of white snail shell is calcium carbonate. This product has the effects of relieving cough and phlegm, strengthening the stomach and promoting digestion, and astringing sores and reducing inflammation. It can relieve cough and phlegm, and is used to treat cough symptoms caused by lung heat and lung dryness. It can relieve cough, excessive phlegm and thick phlegm, and is also effective for difficulty in expectoration and persistent cough.

[0056] Reishi mushroom: The alcoholic extract of reishi mushroom has an inhibitory effect on the central nervous system and has a synergistic effect with the sedative sodium pentobarbital. In addition, the decoction of reishi mushroom has anticonvulsant effects, can inhibit spontaneous activity in mice, and also has a certain analgesic effect.

[0057] Serissa japonica: Serissa japonica contains active ingredients such as glycosides, tannins, phytosterols, small amounts of alkaloids, sugars, and fatty acids. Its decoction can significantly inhibit various bacteria and viruses. Furthermore, clinical practice has shown that Serissa japonica also possesses multiple effects, including disease prevention and anti-aging, enhancing physical strength and immunity.

[0058] The beneficial effects of the present invention are as follows: 1) The traditional Chinese medicine composition of the present invention can effectively treat the lung-stomach disharmony syndrome of laryngopharyngeal reflux disease, and has high safety with no obvious adverse reactions; 2) The traditional Chinese medicine composition of the present invention can improve some of the patient's throat symptoms, especially in terms of erythema / congestion, vocal cord edema, posterior commissure hyperplasia, granuloma, and thick mucus adhesion in the larynx; 3) The traditional Chinese medicine composition of the present invention can improve the patient's TCM syndrome. Attached Figure Description

[0059] Figure 1 To compare the completion status of the two groups of cases ( n ).

[0060] Figure 2 Comparison of gender between the two groups of patients ( n ).

[0061] Figure 3 The age of the two groups of patients was compared.

[0062] Figure 4 To compare the disease course between the two groups of patients.

[0063] Figure 5 This study compares the pre-treatment RFS scores of the two groups.

[0064] Figure 6 This is a comparison of the pre-treatment RSI scores between the two groups.

[0065] Figure 7 This study compares the TCM syndrome scores of the two groups before treatment.

[0066] Figure 8 For the comparison of the overall efficacy between the two groups of patients ( n ).

[0067] Figure 9 This study compares the total RFS scores of the two groups after treatment.

[0068] Figure 10 This is a comparison of the total RSI scores of the two groups after treatment.

[0069] Figure 11 Comparison of TCM syndrome efficacy between two groups of patients ( n ).

[0070] Figure 12 This is a comparison chart of TCM syndrome scores after treatment in the two groups.

[0071] Figure 13 To compare the adverse reactions of the two groups of subjects ( n ). Detailed Implementation

[0072] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present invention.

[0073] Example 1

[0074] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the composition, by weight, include the following ingredients: 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts stir-fried Coptis chinensis, 3 parts processed Evodia rutaecarpa, 9 parts ginger-processed Pinellia ternata, 15 parts processed Magnolia officinalis, 20 parts white snail shell, 20 parts Ganoderma lucidum, and 30 parts Serissa japonica. It is prepared by decoction, with the white snail shell decocted first.

[0075] Example 2

[0076] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the composition, by weight, include the following ingredients: 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts stir-fried Coptis chinensis, 3 parts processed Evodia rutaecarpa, 9 parts ginger-processed Pinellia ternata, 15 parts processed Magnolia officinalis, 20 parts white snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 6 parts Platycodon grandiflorus, and 9 parts Corydalis yanhusuo. It is prepared by decoction, with the white snail shell decocted first.

[0077] Example 3

[0078] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the composition, by weight, include the following ingredients: 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts stir-fried Coptis chinensis, 3 parts processed Evodia rutaecarpa, 9 parts ginger-processed Pinellia ternata, 15 parts processed Magnolia officinalis, 20 parts white snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 20 parts stir-fried Atractylodes macrocephala, 15 parts Poria cocos, and 9 parts white hyacinth bean. It is prepared by decoction, with the white snail shell decocted first.

[0079] Example 4

[0080] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the composition, by weight, include the following ingredients: 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts stir-fried Coptis chinensis, 3 parts processed Evodia rutaecarpa, 9 parts ginger-processed Pinellia ternata, 15 parts processed Magnolia officinalis, 20 parts white snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 6 parts dried tangerine peel, and 6 parts Amomum villosum. It is prepared by decoction, with the white snail shell decocted first and the Amomum villosum added later.

[0081] Example 5

[0082] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the composition, by weight, include the following ingredients: 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts stir-fried Coptis chinensis, 3 parts processed Evodia rutaecarpa, 9 parts ginger-processed Pinellia ternata, 15 parts processed Magnolia officinalis, 20 parts white snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 20 parts stir-fried chicken gizzard lining, 15 parts stir-fried malt, and 15 parts stir-fried rice sprout. It is prepared by decoction, with the white snail shell decocted first.

[0083] Example 6

[0084] A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony syndrome, wherein the active ingredients of the composition, by weight, include the following ingredients: 8 parts of Belamcanda chinensis, 10 parts of Terminalia chebula, 8 parts of Oroxylum indicum, 6 parts of stir-fried Coptis chinensis, 3 parts of processed Evodia rutaecarpa, 9 parts of ginger-processed Pinellia ternata, 15 parts of processed Magnolia officinalis, 20 parts of white snail shell, 20 parts of Ganoderma lucidum, 30 parts of Serissa japonica, 20 parts of calcined oyster shell, and 20 parts of calcined oyster shell. It is prepared by decoction, with the white snail shell, calcined oyster shell, and calcined oyster shell decocted first.

[0085] Study on the beneficial effects of this invention:

[0086] I. Research Materials and Methods

[0087] (a) Research Data

[0088] 1. Research Subjects

[0089] The patients included in this study were all outpatients from October 2021 to January 2023, and were from Linhai City Traditional Chinese Medicine Hospital. Their diagnoses met the Western medicine criteria for laryngopharyngeal reflux disease and the traditional Chinese medicine diagnostic criteria for lung-stomach disharmony.

[0090] 2. Diagnostic criteria and syndrome differentiation criteria

[0091] 2.1 Western Medicine Diagnostic Criteria

[0092] Referring to the diagnostic criteria for laryngopharyngeal reflux disease in the 2020 "Research Progress in Diagnosis and Treatment of Laryngopharyngeal Reflux Disease", the patients were evaluated using the refluxfinding score (RFS) and refluxsymptom index (RSI) through detailed medical history taking and laryngoscopy.

[0093] RFS scoring scale: ① False vocal cord groove: 0 points if absent, 2 points if present; ② Disappearance of laryngeal ventricle: 0 points if absent, 2 points if partially present, 4 points if completely present; ③ Erythema / congestion: 0 points if absent, 2 points if localized to the arytenoid cartilage, 4 points if diffuse; ④ Vocal cord edema: 0 points if absent, 1 point for mild, 2 points for moderate, 3 points for severe, 4 points for obstruction; ⑤ Diffuse laryngeal edema: 0 points if absent, 1 point for mild, 2 points for moderate, 3 points for severe, 4 points for obstruction; ⑥ Posterior commissure hyperplasia: 0 points if absent, 1 point for mild, 2 points for moderate, 3 points for severe, 4 points for obstruction; ⑦ Granuloma: 0 points if absent, 2 points if present; ⑧ Thick mucus adhering to the larynx: 0 points if absent, 2 points if present.

[0094] RSI scoring scale: ① hoarseness or speech impairment; ② persistent throat clearing; ③ excessive sputum or postnasal drip; ④ difficulty swallowing food, water, or pills; ⑤ coughing after meals or lying down; ⑥ difficulty breathing or recurrent episodes of suffocation; ⑦ annoying cough; ⑧ a feeling of something stuck in the throat; ⑨ heartburn, chest pain, or stomach pain. Patients rate their symptoms according to severity, with 0 representing no symptoms and 5 representing very severe symptoms.

[0095] If RFS > 7 and / or RSI > 13, the patient can be diagnosed as suspected laryngopharyngeal reflux disease.

[0096] 2.2 Traditional Chinese Medicine Diagnostic Criteria

[0097] Based on the research results of "A Study on the Distribution Patterns of Traditional Chinese Medicine Syndromes and Symptoms in Laryngopharyngeal Reflux Disease" and combined with clinical practice, this study proposes the following criteria for "Lung-Stomach Disharmony Syndrome" in this disease:

[0098] Main symptoms: ① foreign body sensation in the throat or difficulty swallowing; ② cough, throat clearing or accompanied by phlegm; ③ dry throat, itchy throat or accompanied by sore throat; ④ hoarseness.

[0099] Secondary symptoms: ① sticky feeling in the mouth and throat; ② abdominal distension; ③ poor appetite.

[0100] Tongue and pulse: ① Red tongue with a thin yellow or yellow-greasy coating; ② Weak and rapid pulse.

[0101] A diagnosis can be made by observing two primary symptoms and two or more secondary symptoms, along with an assessment of the tongue and pulse.

[0102] 3. Inclusion criteria

[0103] ① Meets the above-mentioned Western medical diagnostic criteria for laryngopharyngeal reflux disease;

[0104] ② Meets the TCM diagnostic criteria for lung-stomach disharmony syndrome;

[0105] ③ The age range is between 18 and 60 years old;

[0106] ④ I agree to participate in this study and personally sign the informed consent form;

[0107] ⑤ Not taking any medications that treat laryngopharyngeal reflux disease, or if taking them, having stopped taking them for more than 2 weeks before enrollment.

[0108] 4. Exclusion Criteria

[0109] ① Patients with other digestive tract diseases or ENT diseases, or those with liver, kidney or other organ dysfunction;

[0110] ② Individuals allergic to the drugs used in this study (including the traditional Chinese medicine composition of this invention and omeprazole capsules);

[0111] ③ Women who are trying to conceive, breastfeeding, or pregnant;

[0112] ④ Patients with organic lesions, such as laryngeal cancer, esophageal cancer, nasopharyngeal cancer, etc.;

[0113] ⑤ Those who fail to follow medical advice or cooperate with treatment for various reasons;

[0114] ⑥ Those who fell off during the research process for various reasons;

[0115] ⑦ Those with a history of alcoholism or drug abuse;

[0116] ⑧ In cases where the individual is simultaneously participating in other clinical studies, taking other medications, or in other situations where the investigator determines that the individual is not suitable for inclusion.

[0117] 5. Elimination Criteria

[0118] ①Incorrect inclusion;

[0119] ②Those who did not take medication as prescribed by the doctor after enrollment;

[0120] ③ Patients for whom efficacy and safety assessments could not be conducted due to incomplete data collection during the observation period.

[0121] 6. Shedding Criteria

[0122] ① The patient's complications are intolerable;

[0123] ② Other diseases were discovered during the research process;

[0124] ③ Patients are lost to follow-up or voluntarily withdraw from follow-up.

[0125] 7. Criteria for Terminating Clinical Trials

[0126] ① To protect patients' health, the trial should be terminated promptly if a patient experiences a serious adverse reaction during the study.

[0127] ②Those who voluntarily request to terminate this clinical study.

[0128] II) Research Methods

[0129] 1. Sample size estimation

[0130] This study was a randomized, parallel, controlled trial. The overall effective rate of the experimental and control groups was used as the observed outcome measure. The sample size was calculated using the following formula:

[0131]

[0132] in n Z represents the sample size required for each group, and the value represents the two-tailed test result. Let two-tailed = 0.05, with a power of 80%, then Z... α =0.96, Z β =1.28. P 1 and P 2 represents the estimated total effective rate of the experimental group and the control group, respectively, and p represents... P 1 and P The mean of 2, where q represents 1- P 1 and 1- P The mean of 2. By reviewing relevant clinical trial literature on laryngopharyngeal reflux disease, it was found that the overall effective rate in the experimental group of this study was likely around 90%, while the effective rate in the control group was likely around 60%, i.e. P 1 = 0.9 P 2 = 0.6. This is calculated based on the above formula. n =44 cases. Calculations were performed with a shedding rate not exceeding 10%, and the final result was...n 1= n 2=48 (example).

[0133] 2. Grouping method

[0134] Based on the order of their visits after enrollment, all patients were sequentially numbered 1-96. Using SPSS 25.0 statistical software, they were randomly assigned to either group 0 or 1, with 48 patients in each group. Following the correspondence between patient numbers, patients numbered 0 were assigned to the experimental group, and patients numbered 1 were assigned to the control group.

[0135] 3. Treatment Plan

[0136] 3.1 Traditional Chinese Medicine Experimental Group

[0137] The traditional Chinese medicine experimental group was treated mainly with the traditional Chinese medicine composition of the present invention (the composition of the medicine is as follows: 8g of Belamcanda chinensis, 10g of Terminalia chebula, 8g of Oroxylum indicum, 6g of Coptis chinensis (fried), 3g of Evodia rutaecarpa (processed), 9g of Pinellia ternata (processed), 15g of Magnolia officinalis (processed), 20g of white snail shell (decocted first), 20g of Ganoderma lucidum, and 30g of Serissa japonica). For severe sore throat, add 6g of Platycodon grandiflorus and 9g of Corydalis yanhusuo; for severe stickiness in the mouth and throat, add 20g of stir-fried Atractylodes macrocephala, 15g of Poria cocos, and 9g of Dolichos lablab; for abdominal distension, add 6g of Citrus reticulata peel and 6g of Amomum villosum (added later); for poor appetite, add 20g of stir-fried chicken gizzard lining, 15g of stir-fried malt, and 15g of stir-fried rice sprouts; for belching, acid reflux, and heartburn, add 20g of calcined oyster shell (decocted first) and 20g of calcined oyster shell (decocted first); the above Chinese medicinal materials can be decocted by a Chinese medicine pharmacy or by self-decocting, each time 200ml is decocted and taken twice a day, morning and evening; 2 weeks is one course of treatment, and a total of 2 courses of treatment are required.

[0138] 3.2 Western medicine control group

[0139] Omeprazole enteric-coated capsules (Approval number: National Drug Approval Number H19991118, Product Batch Number: JA2205005B. Manufacturer: Zhejiang Jinhua Kang Enbei Biopharmaceutical Co., Ltd.) 20mg, taken orally before meals, twice a day, morning and evening. One course of treatment is 2 weeks, and a total of 2 courses of treatment are required.

[0140] Treatment course and follow-up: The treatment course for both groups was 4 weeks, and follow-up was conducted 4 weeks after the end of the treatment course.

[0141] 4. Observation Indicators

[0142] 4.1 Case Demographic Data

[0143] Record patient information such as name, gender, age, and course of illness in detail and accurately.

[0144] 4.2 Safety Observation Indicators

[0145] Typical physical examination items include: blood pressure, heart rate, heart rhythm, respiration, and weight.

[0146] Relevant examinations: routine blood, urine, and stool tests; liver and kidney function tests; electrocardiogram. These examinations will be conducted before treatment and again 4 weeks after treatment. The patient will be monitored for any toxic side effects after taking the medication.

[0147] 4.3 Indicators for Evaluating Therapeutic Effect

[0148] 4.3.1 Overall efficacy assessment method

[0149] According to the "Standardized Diagnosis and Treatment of Laryngopharyngeal Reflux Disease":

[0150] Significant effect is defined as the disappearance of pharyngeal and laryngeal symptoms, complete disappearance of mucosal congestion under electronic laryngoscopy, or ulcer healing, with an RSI score ≤13.

[0151] It effectively relieved various symptoms in patients, reduced inflammation, improved mucosal lesions under electronic laryngoscopy, and the RSI score was >13 points, but lower than before treatment;

[0152] Ineffective is defined as no improvement in the patient's symptoms and laryngoscopic signs, and no decrease in the RSI score. The RFS and RSI scoring scales can be found in Western medicine diagnostic criteria.

[0153] 4.3.2 Methods for Determining the Therapeutic Effect of Traditional Chinese Medicine Syndromes

[0154] The following efficacy evaluation criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines": Percentage improvement of TCM syndrome = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%.

[0155] Significant efficacy is defined as the basic disappearance of TCM symptoms and signs, and an improvement rate of ≥80% in TCM syndrome.

[0156] Effective improvement of TCM symptoms and signs by more than 50%, that is, 50% ≤ TCM syndrome improvement rate < 80%;

[0157] Ineffective is defined as no improvement in TCM symptoms and signs, and an improvement rate of <50% in TCM syndrome.

[0158] 4.4 Safety Assessment Method

[0159] Accurately record patient adverse reactions and count the number of occurrences in each group. Evaluation criteria are based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs":

[0160] ① Grade I: Safe, no adverse reactions occurred during treatment;

[0161] ② Grade II: Relatively safe. If adverse reactions occur, no special treatment is required, and subsequent drug therapy can be administered.

[0162] ③ Level III: There are safety issues. Certain adverse reactions occurred during the test. After appropriate treatment, subsequent tests can be carried out.

[0163] ④ Grade IV: Serious adverse reactions occur, and the clinical trial needs to be terminated.

[0164] (III) Statistical Methods

[0165] Statistical analysis was performed using SPSS 25.0 software. Chi-square tests were used for count data, and data conforming to or approximately normally distributed distributions were analyzed using... t Tests. Paired comparisons were used to compare results before and after treatment. t Tests and between-group comparisons use two independent samples. t The test is performed using mean ± standard deviation (SD). ± s )express, P <0.05 indicates that the difference is statistically significant.

[0166] II. Results

[0167] (a) Case completion status

[0168] A total of 96 patients were included and randomly assigned to the experimental group and the control group according to a random number table. n 1= n =2 = 48 (cases). During the trial, two patients in each group dropped out due to failure to attend follow-up appointments. Additionally, one patient in the control group was excluded for self-medicating with a drug that could affect the study (pantoprazole), and one patient in the experimental group discontinued the trial due to planning pregnancy. Ultimately, 45 patients were recruited in both the experimental and control groups, completing the study protocol. The overall dropout rate was 6.67%. See Table 1 below. Figure 1 :

[0169] Table 1 Comparison of completion status between the two groups of cases ( n )

[0170] Group Number of cases included Excluded cases Shedding cases Completed Case experimental group 48 0 3 45 control group 48 1 2 45

[0171] (II) Comparison of baseline characteristics of cases

[0172] 1. Gender comparison

[0173] In the experimental group, there were 18 males (40%) and 27 females (60%); in the control group, there were 19 males (57.8%) and 26 females (42.2%). There was no statistically significant difference in gender between the two groups. P >0.05), the two groups are comparable. See Table 2 below. Figure 2 :

[0174] Table 2 Comparison of gender between the two groups of patients ( n )

[0175]

[0176] 2. Age comparison

[0177] Of the 90 patients who met the inclusion criteria, the experimental group ranged in age from 22 to 54 years, with a mean age of (38.89 ± 9.83) years; the control group ranged in age from 25 to 54 years, with a mean age of (40.36 ± 8.27) years. The ages of patients in both groups were close to a normal distribution. Therefore, independent samples were used for comparison. t Test. There was no statistically significant difference in age between the two groups. P >0.05). See Table 3 for details. Figure 3 .

[0178] Table 3 Comparison of ages between the two groups of patients

[0179]

[0180] 3. Comparison of disease course between the two groups

[0181] In the 90 eligible participants, the disease duration in the experimental group ranged from 5 to 47 months, while that in the control group ranged from 6 to 46 months. The disease duration in both groups was approximately normally distributed, and independent samples were used for comparison. t Test. There was no statistically significant difference in age between the two groups. P >0.05). See Table 4 for details. Figure 4 .

[0182] Table 4 Comparison of disease course between the two groups of patients

[0183]

[0184] 4. Comparison of RFS scores between the two groups before treatment

[0185] RFS scores of 90 patients meeting the inclusion criteria were statistically analyzed. The individual symptom scores of the experimental group and the control group before treatment were approximately normally distributed. The comparison was conducted using two independent samples. t The test showed no statistically significant difference. P >0.05 indicates that there were no significant differences in individual symptoms between the two groups before treatment, making them comparable. See Table 5 for details. Figure 5 .

[0186] Table 5 Comparison of RFS scores before treatment in the two groups

[0187]

[0188] 5. Comparison of RSI scores between the two groups before treatment

[0189] The RSI scores of 90 patients meeting the inclusion criteria were statistically analyzed. The pre-treatment individual symptom scores of the experimental group and the control group were approximately normally distributed. The comparison was conducted using two independent samples. t The tests showed no statistically significant differences in any of the items except for persistent throat clearing. P >0.05 indicates that there was no significant difference in individual symptoms between the two groups before treatment, and the two groups are comparable. See Table 6 for details. Figure 6 .

[0190] Table 6 Comparison of RSI scores before treatment in the two groups

[0191]

[0192] 6. Comparison of TCM syndrome scores between the two groups before treatment

[0193] Ninety patients meeting the inclusion criteria were scored according to their TCM syndromes. The scores of individual symptoms in the experimental group and the control group before treatment showed an approximately normal distribution. The comparison was conducted using two independent samples. t The test showed no statistically significant difference. P >0.05 indicates that there were no significant differences in individual TCM syndromes between the two groups before treatment, making them comparable. See Table 7 for details. Figure 7 .

[0194] Table 7 Comparison of TCM syndrome scores between the two groups before treatment

[0195]

[0196] (III) Comparison of therapeutic effects

[0197] 1. Comparison of overall therapeutic effects

[0198] After 4 weeks of treatment, the total effective rate of the herbal composition of this invention in the experimental group for treating laryngopharyngeal reflux disease was 88.88%, while the total effective rate of omeprazole in the control group was 62.22%. The difference in total effective rate between the two groups was statistically significant after chi-square test. P <0.01). See Table 8. Figure 8 :

[0199] Table 8 Comparison of efficacy rates between the two groups of patients ( n )

[0200]

[0201] 2. Comparison of RFS scores before and after treatment in the two groups

[0202] RFS scores were reassessed after treatment in 90 patients. Paired samples were used to compare individual RFS symptoms before and after treatment. tThe test results indicated that, except for the false vocal cord groove, disappearance of the laryngeal ventricle, and granuloma, all other items were statistically significant. P <0.05). Furthermore, in both groups of patients, the herbal composition of this invention showed therapeutic effects in the areas of erythema / congestion, etc. P <0.05), while PPI treatment is less effective ( P >0.05). See Table 9 for details. Figure 9 .

[0203] Table 9 Comparison of RFS scores before and after treatment in the two groups

[0204]

[0205] 3. Comparison of RSI scores before and after treatment in the two groups

[0206] After treatment, the RSI scores of both groups of patients were reassessed. Paired samples were used to compare the individual symptom scores after treatment with those before treatment. t In the experimental group, all items except for dysphagia, difficulty breathing, or recurrent episodes of suffocation were statistically significant. P <0.05), and in the control group, only excessive sputum or postnasal drip, annoying cough, heartburn, chest pain, and stomach pain were statistically significant ( P <0.05). See Table 10. Figure 10 .

[0207] Table 10 Comparison of RSI scores before and after treatment in the two groups

[0208]

[0209] 4. Comparison of TCM syndrome differentiation and efficacy before and after treatment

[0210] After 4 weeks of treatment, the total effective rate of the herbal composition of this invention in treating laryngopharyngeal reflux disease was 80.00%, while the total effective rate of PPI in treating laryngopharyngeal reflux disease was 48.89%. The difference in the total effective rate between the herbal composition of this invention and PPI was statistically significant. P <0.05). See Table 11. Figure 11 :

[0211] Table 11 Comparison of the effective rates of TCM syndrome treatment between the two groups of patients ( n )

[0212]

[0213] 5. Comparison of TCM syndrome scores before and after treatment in the two groups

[0214] After the trial of 90 patients was completed, the results of TCM syndrome differentiation were statistically analyzed again. Paired samples were used to compare individual symptoms between the two groups after treatment and before treatment. tThe test results showed that all parameters in the experimental group were statistically significant. P <0.05), the control group showed statistically significant differences in pharyngeal foreign body sensation or difficulty swallowing, oral and pharyngeal stickiness, and abdominal distension. P <0.05). See Table 12 for details. Figure 12 .

[0215] Table 12 Comparison of TCM syndrome scores before and after treatment in the two groups

[0216]

[0217] (iv) Safety Comparison

[0218] After the experiment, the vital signs of both groups of subjects were within the normal range, and no significant abnormalities were found in the results of routine blood tests, urine tests, stool tests, and routine electrocardiograms before and after treatment. However, during the study, 3 cases of dizziness, 8 cases of diarrhea, and 3 cases of abnormal liver function occurred in the control group, while 0 cases of dizziness and 2 cases of bitter taste in the treatment group occurred. There was a statistically significant difference in the adverse reaction rate between the two groups. P <0.01). See Table 13. Figure 13 .

[0219] Table 13 Comparison of adverse reactions between the two groups of subjects ( n )

[0220]

[0221] III. Analysis of Research Results

[0222] (I) Analysis of Case Demographic Data

[0223] A total of 96 patients with pharyngeal reflux disease due to lung-stomach disharmony were included, and 90 patients ultimately completed the study, including 37 males and 53 females. Although there was no statistically significant difference in the male-to-female ratio between the two groups ( P >0.05), but the number of female patients was significantly higher than that of male patients, which may be related to the fact that women are more susceptible to stress and psychological factors that can cause acid reflux. The mean age of patients in the experimental group was (38.89±9.83) years, and the mean age of patients in the control group was (40.36±8.27) years. There was no statistically significant difference in age between the two groups. P The incidence rate was >0.05, with the age range of onset being primarily young and middle-aged adults, possibly related to the predominantly affected population at tertiary hospitals. In this study, the average disease duration in the experimental group was (28.40±12.79) months, while the average disease duration in the control group was (27.84±13.46) months, indicating that laryngopharyngeal reflux disease (LDR) has a long course and places significant stress on patients' lives and finances. However, this study had a small sample size and a single sample source, therefore it cannot represent the overall demographic characteristics of LDR patients.

[0224] (II) Analysis of clinical efficacy and TCM syndrome efficacy before and after treatment

[0225] After 4 weeks of treatment, the total effective rate for laryngopharyngeal reflux disease in the experimental group was 88.88%, while that in the control group was 62.22%. The difference in total effective rate between the two groups was statistically significant. P <0.05). The effective rate of TCM syndrome in the experimental group for laryngopharyngeal reflux disease was 80.00%, while that in the control group was 48.89%. The difference in the effective rate of TCM syndrome between the two groups was statistically significant. P <0.05). The effectiveness of PPI treatment during this period was not entirely satisfactory, which can be explained by the following: Although the association between reflux disease and throat symptoms is well-established, and more than half of attending physicians use PPIs in treatment, the exact pathological mechanism leading to laryngopharyngeal reflux disease (LDR) remains unclear. LDR may be caused by a variety of complex factors, resulting in a low success rate for empirical PPI treatment. Currently, PPIs are the first-line treatment for LDR, but studies have shown that up to 40% of LDR patients do not experience symptom relief with PPIs, similar to our results. Therefore, substantial clinical evidence regarding the effectiveness of PPIs for LDR lacks sufficient evidence. Given the complexity of the symptoms and mechanisms of LDR and the questionable efficacy of PPIs, traditional Chinese medicine has a greater advantage in treating LDR. Patients with laryngopharyngeal reflux disease (LDR) experience a range of symptoms including a dull, dry throat, a feeling of obstruction as if something is stuck in the throat, difficulty coughing up or swallowing, or only being able to expectorate a small amount of white, sticky phlegm. They also experience a feeling of tightness and choking in the throat and chest, persistent belching that is relieved by belching, and sometimes a burning sensation in the throat and chest. In addition, they often experience epigastric fullness and pain, abdominal distension, belching, heartburn, and poor appetite. This condition is similar to "globus hystericus" (plum pit syndrome). Traditional treatments, focusing on the interaction between phlegm and qi, often use herbs to soothe the liver, regulate qi, and resolve phlegm, such as Banxia Houpu Tang, but these are often ineffective. The applicant's invention, a traditional Chinese medicine composition for treating LDR caused by lung-stomach disharmony, focuses on the patient's symptoms and is tailored to the pathogenesis of the southern population, thus demonstrating significant clinical efficacy.

[0226] (III) Analysis of RFS and RSI scores before and after treatment

[0227] The RSI and RFS scales are widely used diagnostic tools for laryngopharyngeal reflux disease (LDR). RSI and RFS can be used to assess and quantify a patient's physical symptoms and the severity of LDR. An RSI score >13 is considered a reliable diagnostic indicator for LDR, and these patients often undergo laryngoscopy to further quantify their LDR using RFS. RFS aims to score patients based on endoscopic findings; a score of 7 or higher is generally considered diagnostically significant for LDR. After 4 weeks of treatment with different regimens, the before-and-after comparisons of "erythema / congestion," "vocal cord edema," "posterior commissure hyperplasia," "granuloma," and "thick mucus adhesion in the laryngeal cavity" in each group were statistically significant. P <0.05), which suggests that the PPI and the herbal composition of this invention are effective in treating the above-mentioned conditions in both groups of patients. However, in the case of "diffuse laryngeal edema," the experimental group... P <0.05, control group P A value >0.05 indicates that traditional Chinese medicine can improve the diffuse laryngeal edema signs in patients with laryngopharyngeal reflux disease (LDR), but the efficacy of PPI treatment is limited. Flexible nasopharyngoscopy allows direct observation of the pharynx and larynx. LDR commonly presents with typical inflammatory features under nasopharyngoscopy, including dry pharyngeal mucosa with thick secretions or mucus, a cobblestone appearance of the mucosa, and edema and erythema of the vocal cords and supraglottic region. Patients with LDR may experience thickening and edema behind the glottis, which can extend to the subglottic region, causing stenosis. Granulomas may also appear in the glottic, subglottic, or supraglottic regions. Depending on the size and location of the vocal cord granulomas, vocal cord movement may be restricted, and adduction may be impaired. Therefore, the terms "disappearance of the laryngeal ventricle" and "false vocal cord groove" are different. P >0.05 is because these two signs are very rare in patients with laryngopharyngeal reflux disease. There was a statistically significant difference between the erythema / congestion test group and the control group after treatment ( P <0.05), suggesting that traditional Chinese medicine treatment has a greater advantage in improving this sign. This suggests that in clinical practice, when encountering patients with laryngopharyngeal reflux disease with significant erythema / congestion, the traditional Chinese medicine composition of this invention may have a better effect than PPI treatment. Analysis of RSI score results showed that, except for dysphagia, dyspnea, or recurrent asphyxia, all other items in the experimental group were statistically significant ( P <0.05), which suggests that the herbal composition of the present invention is effective for most symptoms of laryngopharyngeal reflux disease. The reason why the improvement of difficulty swallowing, difficulty breathing or recurrent suffocation may be poor is that these patients have a long course of disease, severe symptoms, and a small number of cases, making it difficult to obtain statistically positive results; while the control group only showed statistical significance for excessive sputum or postnasal drip, annoying cough, heartburn, chest pain and stomach pain. PThe result (<0.05) suggests that PPIs have limited ability to improve symptoms in patients with laryngopharyngeal reflux disease (LDR), and since heartburn, chest pain, and stomach pain are also related symptoms of gastrointestinal diseases, they may have a higher response rate to PPI treatment. Overall, in clinical practice, for patients with LDR who exhibit persistent hoarseness or speech difficulties, significant throat clearing, coughing after meals or lying down, coughing, and a foreign body sensation in the throat, the herbal composition of this invention may be more effective than PPI treatment.

[0228] (iv) Analysis of TCM syndrome scores before and after treatment

[0229] Analysis of TCM syndrome data after treatment showed that the experimental group had statistically significant results in all aspects of TCM syndromes. P <0.05), the control group only showed statistical significance in symptoms such as a foreign body sensation in the throat or difficulty swallowing, a sticky feeling in the mouth and throat, and abdominal distension. P <0.05). In the herbal composition of this invention, theoretically, Belamcanda chinensis, Terminalia chebula, and Oroxylum indicum moisten the lungs and soothe the throat; Serissa japonica and processed Evodia rutaecarpa counteract the effects of stir-fried Coptis chinensis to clear and reduce deficiency fire; Pinellia ternata and processed Magnolia officinalis dry dampness, resolve phlegm, relieve nausea and vomiting, dissipate lumps and nodules; and white snail shell is added to resolve dampness, stop reflux, harmonize the stomach, and relieve pain. Finally, Ganoderma lucidum is added to nourish qi and blood, calm the mind, and strengthen the lungs and stomach. The whole formula works together to benefit the throat, reduce stomach reflux, moisten the lungs, and clear heat, so that the qi mechanism of the lungs and stomach can be unblocked, thus eliminating deficiency fire, relieving reflux, and alleviating throat discomfort. The research results show that the herbal composition of this invention does have the effect of improving the TCM syndrome of laryngopharyngeal reflux disease. However, it is not very obvious on the tongue and pulse, possibly because the manifestation of the depth of the disease on the tongue and pulse is not as rapid as the symptoms. Overall, PPI treatment did not significantly improve TCM symptoms. This may be due to decreased UES pressure and esophageal motility in the elderly to reflux and post-reflux residues, and the presence of hiatal hernia leading to refractory laryngopharyngeal reflux disease. PPIs can treat epigastric fullness because epigastric fullness is also a symptom of gastrointestinal diseases, and therefore may have a higher response rate to PPI treatment.

[0230] (iv) Security Analysis

[0231] During the study, 3 patients in the control group experienced dizziness, 8 patients experienced diarrhea, and 3 patients experienced abnormal liver function. In the treatment group, 0 patients experienced dizziness and 2 patients experienced bitter taste in their mouth. There was a statistically significant difference in the adverse reaction rates between the two groups. P <0.05). This demonstrates the safety of traditional Chinese medicine treatment.

[0232] The foregoing description of embodiments of the present invention, through which those skilled in the art are able to implement or use the present invention, will be readily apparent to those skilled in the art. Various modifications to these embodiments will be readily apparent to those skilled in the art. The general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novelty disclosed herein.

Claims

1. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of Coptis chinensis (fried), 1-5 parts of Evodia rutaecarpa (processed), 5-15 parts of Pinellia ternata (processed), 10-20 parts of Magnolia officinalis (processed), 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, and 25-35 parts of Serissa japonica.

2. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for making the active ingredients of the traditional Chinese medicine composition are, by weight: 8 parts of Belamcanda chinensis, 10 parts of Terminalia chebula, 8 parts of Oroxylum indicum, 6 parts of Coptis chinensis (fried), 3 parts of Evodia rutaecarpa (processed), 9 parts of Pinellia ternata (processed), 15 parts of Magnolia officinalis (processed), 20 parts of white snail shell, 20 parts of Ganoderma lucidum, and 30 parts of Serissa japonica.

3. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of Coptis chinensis (fried), 1-5 parts of Evodia rutaecarpa (processed), 5-15 parts of Pinellia ternata (processed), 10-20 parts of Magnolia officinalis (processed), 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, 25-35 parts of Serissa japonica, 2-10 parts of Platycodon grandiflorus, and 5-15 parts of Corydalis yanhusuo.

4. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of stir-fried Coptis chinensis, 1-5 parts of processed Evodia rutaecarpa, 5-15 parts of ginger-processed Pinellia ternata, 10-20 parts of processed Magnolia officinalis, 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, 25-35 parts of Serissa japonica, 15-25 parts of stir-fried Atractylodes macrocephala, 10-20 parts of Poria cocos, and 5-15 parts of white hyacinth bean.

5. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of stir-fried Coptis chinensis, 1-5 parts of processed Evodia rutaecarpa, 5-15 parts of ginger-processed Pinellia ternata, 10-20 parts of processed Magnolia officinalis, 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, 25-35 parts of Serissa japonica, 2-10 parts of dried tangerine peel, and 2-10 parts of Amomum villosum.

6. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of stir-fried Coptis chinensis, 1-5 parts of processed Evodia rutaecarpa, 5-15 parts of ginger-processed Pinellia ternata, 10-20 parts of processed Magnolia officinalis, 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, 25-35 parts of Serissa japonica, 15-25 parts of stir-fried chicken gizzard lining, 10-20 parts of stir-fried malt, and 10-20 parts of stir-fried rice sprouts.

7. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 4-12 parts of Belamcanda chinensis, 5-15 parts of Terminalia chebula, 4-12 parts of Oroxylum indicum, 2-10 parts of stir-fried Coptis chinensis, 1-5 parts of processed Evodia rutaecarpa, 5-15 parts of ginger-processed Pinellia ternata, 10-20 parts of processed Magnolia officinalis, 15-25 parts of white snail shell, 15-25 parts of Ganoderma lucidum, 25-35 parts of Serissa japonica, 15-25 parts of calcined oyster shell, and 15-25 parts of calcined oyster shell.

8. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for making the active ingredients of the traditional Chinese medicine composition are as follows (by weight): 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts Coptis chinensis (fried), 3 parts Evodia rutaecarpa (processed), 9 parts Pinellia ternata (processed), 15 parts Magnolia officinalis (processed), 20 parts White snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 6 parts Platycodon grandiflorus, and 9 parts Corydalis yanhusuo.

9. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 8 parts of Belamcanda chinensis, 10 parts of Terminalia chebula, 8 parts of Oroxylum indicum, 6 parts of Coptis chinensis (fried), 3 parts of Evodia rutaecarpa (processed), 9 parts of Pinellia ternata (processed), 15 parts of Magnolia officinalis (processed), 20 parts of white snail shell, 20 parts of Ganoderma lucidum, 30 parts of Serissa japonica, 20 parts of Atractylodes macrocephala (fried), 15 parts of Poria cocos, and 9 parts of Dolichos lablab.

10. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for making the active ingredients of the traditional Chinese medicine composition are as follows (by weight): 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts Coptis chinensis (fried), 3 parts Evodia rutaecarpa (processed), 9 parts Pinellia ternata (processed), 15 parts Magnolia officinalis (processed), 20 parts White snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 6 parts Citrus reticulata peel, and 6 parts Amomum villosum.

11. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for preparing the active ingredients of the traditional Chinese medicine composition are, by weight: 8 parts of Belamcanda chinensis, 10 parts of Terminalia chebula, 8 parts of Oroxylum indicum, 6 parts of Coptis chinensis (fried), 3 parts of Evodia rutaecarpa (processed), 9 parts of Pinellia ternata (processed), 15 parts of Magnolia officinalis (processed), 20 parts of white snail shell, 20 parts of Ganoderma lucidum, 30 parts of Serissa japonica, 20 parts of chicken gizzard lining (fried), 15 parts of malt (fried), and 15 parts of rice sprouts (fried).

12. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The raw materials for making the active ingredients of the traditional Chinese medicine composition are as follows (by weight): 8 parts Belamcanda chinensis, 10 parts Terminalia chebula, 8 parts Oroxylum indicum, 6 parts stir-fried Coptis chinensis, 3 parts processed Evodia rutaecarpa, 9 parts ginger-processed Pinellia ternata, 15 parts processed Magnolia officinalis, 20 parts white snail shell, 20 parts Ganoderma lucidum, 30 parts Serissa japonica, 20 parts calcined oyster shell, and 20 parts calcined oyster shell.

13. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony, characterized in that, The traditional Chinese medicine composition preparation is made from the traditional Chinese medicine composition and / or pharmaceutical excipients as described in any one of claims 1-12.

14. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony according to claim 13, characterized in that, The traditional Chinese medicine composition preparation is in the form of tablets, powders, capsules, ointments, pills, or liquid preparations.

15. A traditional Chinese medicine composition for treating laryngopharyngeal reflux disease with lung-stomach disharmony according to claim 13, characterized in that, The traditional Chinese medicine composition is a chewable tablet or granule.

16. The use of the traditional Chinese medicine composition according to any one of claims 1-12 or the traditional Chinese medicine composition preparation according to any one of claims 13-15 in the preparation of a medicine for treating laryngopharyngeal reflux disease with lung-stomach disharmony.

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