Traditional Chinese medicine composition for treating gastroesophageal reflux cough and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating gastroesophageal reflux cough and a preparation method thereof. The traditional Chinese medicine composition disclosed by the invention is constructed by carefully selecting a medicine formula under the guidance of a traditional Chinese medicine theory and clinical experience and through a compatibility theory of monarch, minister, assistant and guide of traditional Chinese medicines. In the traditional Chinese medicine composition, the inula flower has the effects of promoting blood circulation, removing stasis and turbidity, clearing the airway and removing phlegm and fluid retention, and the mangnolia officinalis has the effects of promoting qi circulation, removing food retention, calming adverse-rising energy and relieving asthma, and both serve as monarch drugs; the dried orange peel has the effects of regulating qi and removing stagnation, the poria cocos has the effects of tonifying spleen, eliminating dampness and phlegm and breaking up the source of phlegm, and the bulbus fritillariae cirrhosae has the effects of clearing heat and moistening lung and resolving phlegm and relieving asthma; the rhizoma atractylodis macrocephalae has the effects of invigorating the spleen, replenishing qi, eliminating dampness and inducing diuresis, and the endothelium corneum gigeriae galli has the effects of promoting digestion and invigorating the stomach and is an assistant and guide drug. The whole prescription is ordered in monarch and minister, focuses on pathogenesis, is rigorous in prescription, has the effects of relieving cough and asthma, clearing heat and moistening lung, and strengthening spleen and stomach, and treats both symptoms and root causes of cough.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating gastroesophageal reflux cough and its preparation method. Background Technology

[0002] Gastroesophageal reflux disease (GERD) is a common gastrointestinal motility disorder caused by abnormalities in the structure or function of the anti-reflux barrier, leading to the reflux of stomach contents into the esophagus, pharynx, mouth, and lungs, resulting in corresponding symptoms or complications. Cough caused by GERD can be divided into two main categories: one is cough accompanied by typical reflux symptoms. The term "stomach cough" was first mentioned in the *Huangdi Neijing* (Yellow Emperor's Inner Classic), and the *Suwen* (Plain Questions) section on cough states: "The symptoms of stomach cough are coughing and vomiting; if the vomiting is severe, long worms will be expelled." The *Jingyue Quanshu* (Complete Works of Jingyue) on cough states: "In my view, the essentials of cough are only two symptoms… one is external pathogenic factor, and the other is internal injury, and that is all." Cough is accompanied by vomiting, acid reflux, heartburn, and other symptoms. The other category is cough without typical reflux symptoms, which is easily misdiagnosed as a lung disease.

[0003] Gastroesophageal reflux cough (GERD) is a clinical syndrome characterized by coughing, caused by the reflux of gastric acid and other gastric contents into the esophagus. It is a specific type of gastroesophageal reflux disease (GERD) and a common cause of chronic cough. Current research suggests that GERD may result from the combined effects of multiple factors, including microaspiration, esophageal-tracheal reflex, neuronal dysfunction, immune mediation, psychological factors, and non-gastric H1N1 cough. + / K + -ATPase, acid-producing enzymes, etc. Western medicine uses prokinetic agents, acid suppressants, mucosal protectants, esophageal sphincter relaxants, antibiotics, and proton pump inhibitors. Although these methods have some inhibitory effect on the disease, long-term use can lead to many adverse reactions such as headache, abdominal pain, nausea, vomiting, diarrhea, constipation, dermatitis, itching, dizziness, dry mouth, and urticaria. It is difficult to control the recurrence of the disease, let alone achieve a radical cure. Summary of the Invention

[0004] The purpose of this invention is to provide a safe and effective traditional Chinese medicine composition for treating gastroesophageal reflux cough and its preparation method.

[0005] This invention provides a traditional Chinese medicine composition for treating gastroesophageal reflux cough, the composition being made from Inula japonica, Magnolia officinalis, Citrus reticulata peel, Poria cocos, Fritillaria cirrhosa, Citrus aurantium, Atractylodes macrocephala, and chicken gizzard lining.

[0006] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux cough is made from the following raw materials: 7-12 parts of Inula japonica, 8-13 parts of Magnolia officinalis, 8-13 parts of Citrus reticulata peel, 12-18 parts of Poria cocos, 2-6 parts of Fritillaria cirrhosa, 8-13 parts of Citrus aurantium, 10-15 parts of Atractylodes macrocephala, and 8-13 parts of chicken gizzard lining.

[0007] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux cough comprises the following ingredients by weight: 9 parts of Inula japonica, 10 parts of Magnolia officinalis, 10 parts of Citrus reticulata peel, 15 parts of Poria cocos, 3 parts of Fritillaria cirrhosa, 10 parts of Citrus aurantium, 12 parts of Atractylodes macrocephala, and 10 parts of chicken gizzard lining.

[0008] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux cough comprises the following ingredients by weight: 12 parts of Inula japonica, 8 parts of Magnolia officinalis, 13 parts of Citrus reticulata peel, 12 parts of Poria cocos, 6 parts of Fritillaria cirrhosa, 13 parts of Citrus aurantium, 10 parts of Atractylodes macrocephala, and 8 parts of chicken gizzard lining.

[0009] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux cough comprises the following ingredients by weight: 7 parts of Inula japonica, 13 parts of Magnolia officinalis, 8 parts of Citrus reticulata peel, 18 parts of Poria cocos, 2 parts of Fritillaria cirrhosa, 8 parts of Citrus aurantium, 15 parts of Atractylodes macrocephala, and 13 parts of chicken gizzard lining.

[0010] The preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux cough of the present invention is as follows: weigh each medicinal material, mix them, soak them in water, decoct them, filter them, and combine the filtrates to obtain the traditional Chinese medicine composition decoction for treating gastroesophageal reflux cough.

[0011] Furthermore, the preparation method of the present invention is as follows: weigh each medicinal material, soak for 30-50 minutes, decoct with purified water, decoct twice, add 500 mL of purified water each time, decoct for 30-60 minutes each time, concentrate the filtrate, combine the filtrates, and the decoction of traditional Chinese medicine composition for treating gastroesophageal reflux cough is obtained.

[0012] The traditional Chinese medicine composition for treating gastroesophageal reflux cough described in this invention is prepared in the form of decoction, pill, gel, tablet, mixture, capsule, granule, powder or ointment.

[0013] Furthermore, the traditional Chinese medicine composition for treating gastroesophageal reflux cough is prepared as a decoction.

[0014] This invention provides the use of the traditional Chinese medicine composition for treating gastroesophageal reflux cough in the preparation of drugs for the prevention or treatment of gastroesophageal reflux cough.

[0015] The pharmacological effects of each ingredient in the traditional Chinese medicine composition for treating gastroesophageal reflux cough of this invention are as follows: Inula japonica: Salty in taste, warm in nature, enters the lung, spleen, stomach and large intestine meridians, lowers qi, eliminates phlegm, promotes diuresis and stops vomiting; used to treat wind-cold cough, phlegm accumulation, chest tightness, wheezing with excessive phlegm, vomiting and belching, and epigastric fullness and hardness.

[0016] Magnolia officinalis: It tastes bitter and pungent, and is warm in nature. It enters the spleen, stomach, and large intestine meridians. It promotes qi circulation and eliminates food stagnation; dries dampness and relieves fullness; and relieves nausea and asthma. It is mainly used to treat food stagnation and qi stagnation; abdominal distension and constipation; dampness obstructing the middle jiao, causing epigastric fullness, vomiting, and diarrhea; phlegm accumulation and qi reversal; and chest fullness, wheezing, and cough.

[0017] Dried tangerine peel: pungent and bitter in taste, warm in nature, enters the spleen, stomach, and lung meridians. It regulates qi and strengthens the spleen, harmonizes the middle jiao, dries dampness, and resolves phlegm. It is used for abdominal distension or pain due to spleen and stomach qi stagnation, indigestion, chest tightness and abdominal distension due to dampness obstructing the middle jiao, poor appetite and loose stools. It is also used for cough and asthma due to phlegm and dampness obstructing the lungs, and for chest and abdominal distension, poor appetite, vomiting and diarrhea, and cough with excessive phlegm.

[0018] Poria cocos: sweet in taste, neutral in nature, enters the heart, spleen, kidney and lung meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations and gastroesophageal reflux cough.

[0019] Fritillaria cirrhosa: It tastes bitter and sweet, and is slightly cold in nature. It enters the lung and heart meridians. It has the effects of clearing heat and moistening the lungs, resolving phlegm and relieving cough, and dispersing nodules and eliminating carbuncles. It is mainly used to treat dry cough due to lung heat, dry cough with little phlegm, yin deficiency and consumptive cough, hemoptysis, scrofula, mastitis, lung abscess, etc.

[0020] Fructus Aurantii Immaturus: It tastes bitter, pungent, and sour, and is slightly cold in nature. It enters the spleen and stomach meridians, regulates qi and relieves chest tightness, and promotes the flow of qi and relieves bloating. It is used for qi stagnation in the chest and ribs, fullness and pain, food stagnation, phlegm retention, and organ prolapse.

[0021] Atractylodes macrocephala: It tastes bitter and sweet, is warm in nature, and enters the liver and kidney meridians. It invigorates the spleen and replenishes qi, dries dampness and promotes diuresis. It is used for symptoms such as poor appetite due to spleen deficiency, indigestion, diarrhea, edema, spontaneous sweating, and threatened abortion.

[0022] Chicken gizzard lining: sweet in taste, neutral in nature, enters the spleen, stomach, small intestine and bladder meridians. It strengthens the stomach and promotes digestion, astringes essence and stops seminal emission, and clears urinary stones and dissolves stones. It is used for indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, seminal emission, painful urination with stones, and gallbladder distension and hypochondriac pain.

[0023] The mechanism of action of the traditional Chinese medicine formulation in this invention is as follows: This invention relates to a traditional Chinese medicine composition formulated based on carefully selected herbs, guided by traditional Chinese medicine theory and clinical experience, and constructed using the principles of principal, assistant, adjuvant, and guide herbs in traditional Chinese medicine. In this composition, Inula japonica promotes blood circulation, removes blood stasis and turbidity, clears the airways, and eliminates phlegm; Magnolia officinalis promotes qi circulation, eliminates stagnation, and relieves asthma; these two herbs together serve as the principal herbs. Citrus reticulata peel regulates qi and removes stagnation; Poria cocos strengthens the spleen, dries dampness, and resolves phlegm, cutting off the source of phlegm production; Fritillaria cirrhosa clears heat, moistens the lungs, resolves phlegm, and relieves asthma; these two herbs together serve as the assistant herbs. Citrus aurantium enters the chest, diaphragm, lungs, and stomach, relieving lung discomfort and upward flow of qi; Atractylodes macrocephala strengthens the spleen, replenishes qi, dries dampness, and promotes diuresis; and chicken gizzard membrane aids digestion and strengthens the stomach; these herbs serve as the adjuvant and guide herbs. The entire formula follows a proper order of principal and assistant herbs, precisely targeting the pathogenesis, and is meticulously formulated. Together, they achieve the effects of relieving cough and asthma, clearing heat and moistening the lungs, and strengthening the spleen and stomach, thus treating both the symptoms and the root cause of cough.

[0024] Compared with the prior art, the present invention has the following advantages: The herbal composition of this invention significantly reduces lung tissue permeability, reduces airway inflammation, and significantly improves symptoms of gastroesophageal reflux cough. The synergistic effect of multiple medicinal ingredients in the herbal composition of this invention achieves the therapeutic effect on gastroesophageal reflux cough.

[0025] The herbal composition of this invention can harmonize and regulate stomach qi, promote lung qi, and soothe liver qi, thereby improving the patient's quality of life while treating the disease. Attached Figure Description

[0026] Figure 1 To compare the tracheal tissue inflammation scores of each group with the model control group, P < 0.05 P < 0.01; compared with Example 1 group, # P < 0.05.

[0027] Figure 2 To compare the concentration of dye permeability in lung tissue among different groups, and to compare with the model control group, P < 0.05 P < 0.01; compared with Example 1 group, # P < 0.05 ## P < 0.01.

[0028] Figure 3 The scores of daytime cough symptoms were compared among the groups, and compared with those before treatment. P < 0.05 P < 0.01; compared with the control group after treatment, △ P < 0.05.

[0029] Figure 4 To compare the nighttime cough symptom scores of each group with those before treatment, P < 0.05 P < 0.01; compared with the control group after treatment, △ P < 0.05. Detailed Implementation

[0030] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings, but the scope of protection of the present invention is not limited to the following description.

[0031] Example 1 A traditional Chinese medicine composition for the prevention or treatment of gastroesophageal reflux cough is made from the following raw materials: 9 parts of Inula japonica, 10 parts of Magnolia officinalis, 10 parts of Citrus reticulata peel, 15 parts of Poria cocos, 3 parts of Fritillaria cirrhosa, 10 parts of Citrus aurantium, 12 parts of Atractylodes macrocephala, and 10 parts of chicken gizzard lining.

[0032] Weigh out each herb, soak for 50 minutes, decoct with purified water twice, adding 500 mL of purified water each time, and decoct for 60 minutes each time. Concentrate the filtrate, combine the filtrates, and you will get a traditional Chinese medicine decoction for treating gastroesophageal reflux cough.

[0033] Example 2 A traditional Chinese medicine composition for the prevention or treatment of gastroesophageal reflux cough is made from the following raw materials: 12 parts of Inula japonica, 8 parts of Magnolia officinalis, 13 parts of Citrus reticulata peel, 12 parts of Poria cocos, 6 parts of Fritillaria cirrhosa, 13 parts of Citrus aurantium, 10 parts of Atractylodes macrocephala, and 8 parts of chicken gizzard lining.

[0034] Weigh out each herb, soak for 35 minutes, decoct with purified water twice, adding 500 mL of purified water each time, and decoct for 60 minutes each time. Concentrate the filtrate, combine the filtrates, and you will get a traditional Chinese medicine decoction for treating gastroesophageal reflux cough.

[0035] Example 3 A traditional Chinese medicine composition for the prevention or treatment of gastroesophageal reflux cough is made from the following raw materials: 7 parts of Inula japonica, 13 parts of Magnolia officinalis, 8 parts of Citrus reticulata peel, 18 parts of Poria cocos, 2 parts of Fritillaria cirrhosa, 8 parts of Citrus aurantium, 15 parts of Atractylodes macrocephala, and 13 parts of chicken gizzard lining.

[0036] Weigh out each herb, soak for 35 minutes, decoct with purified water twice, adding 500 mL of purified water each time, and decoct for 40 minutes each time. Concentrate the filtrate, combine the filtrates, and you will get a traditional Chinese medicine decoction for treating gastroesophageal reflux cough.

[0037] Example 4 A traditional Chinese medicine composition for the prevention or treatment of gastroesophageal reflux cough is made from the following raw materials: 9 parts of Inula japonica, 8 parts of Magnolia officinalis, 13 parts of Citrus reticulata peel, 15 parts of Poria cocos, 2 parts of Fritillaria cirrhosa, 10 parts of Citrus aurantium, 10 parts of Atractylodes macrocephala, and 13 parts of chicken gizzard lining.

[0038] Weigh out each herb, soak for 40 minutes, decoct with purified water twice, adding 500 mL of purified water each time, and decoct for 50 minutes each time. Concentrate the filtrate, combine the filtrates, and you will get a traditional Chinese medicine decoction for treating gastroesophageal reflux cough.

[0039] Example 5 A traditional Chinese medicine composition for the prevention or treatment of gastroesophageal reflux cough is made from the following raw materials: 12 parts of Inula japonica, 10 parts of Magnolia officinalis, 8 parts of Citrus reticulata peel, 18 parts of Poria cocos, 6 parts of Fritillaria cirrhosa, 13 parts of Citrus aurantium, 15 parts of Atractylodes macrocephala, and 10 parts of chicken gizzard lining.

[0040] Weigh out each herb, soak for 50 minutes, decoct with purified water twice, adding 500 mL of purified water each time, and decoct for 60 minutes each time. Concentrate the filtrate, combine the filtrates, and you will get a traditional Chinese medicine decoction for treating gastroesophageal reflux cough.

[0041] Example 6 A traditional Chinese medicine composition for the prevention or treatment of gastroesophageal reflux cough is made from the following raw materials: 7 parts of Inula japonica, 13 parts of Magnolia officinalis, 10 parts of Citrus reticulata peel, 12 parts of Poria cocos, 3 parts of Fritillaria cirrhosa, 8 parts of Citrus aurantium, 12 parts of Atractylodes macrocephala, and 8 parts of chicken gizzard lining.

[0042] Weigh out each herb, soak for 35 minutes, decoct with purified water twice, adding 500 mL of purified water each time, and decoct for 30 minutes each time. Concentrate the filtrate, combine the filtrates, and you will get a traditional Chinese medicine decoction for treating gastroesophageal reflux cough.

[0043] Comparative Example 1 10 parts dried tangerine peel, 15 parts Poria cocos, 3 parts Fritillaria cirrhosa, 10 parts Citrus aurantium, 12 parts Atractylodes macrocephala, and 10 parts chicken gizzard lining.

[0044] Compared with Example 1, the difference is that it does not contain Inula japonica or Magnolia officinalis, while the other components and their amounts remain the same.

[0045] The preparation method is the same as in Example 1.

[0046] Comparative Example 2 Nine parts of Inula japonica, 10 parts of Magnolia officinalis, 3 parts of Fritillaria cirrhosa, 10 parts of Citrus aurantium, 12 parts of Atractylodes macrocephala, and 10 parts of chicken gizzard lining.

[0047] Compared with Example 1, the difference is that it does not contain tangerine peel or poria cocos, while the other components and their amounts remain the same.

[0048] The preparation method is the same as in Example 1.

[0049] Comparative Example 3 Nine parts of Inula japonica, 10 parts of Magnolia officinalis, 10 parts of Citrus reticulata peel, 15 parts of Poria cocos, 12 parts of Atractylodes macrocephala, and 10 parts of chicken gizzard lining.

[0050] Compared with Example 1, the difference is that it does not contain Fritillaria cirrhosa or Citrus aurantium, while the other components and their amounts remain the same.

[0051] The preparation method is the same as in Example 1.

[0052] Comparative Example 4 Inula japonica 9 parts, Citrus reticulata peel 10 parts, Poria cocos 15 parts, Fritillaria cirrhosa 3 parts, Citrus aurantium 10 parts and Atractylodes macrocephala 22 parts.

[0053] Compared with Example 1, the difference is that it does not contain Magnolia officinalis, the amount of Atractylodes macrocephala is increased, it does not contain chicken gizzard lining, and the other components and their amounts remain unchanged.

[0054] The preparation method is the same as in Example 1.

[0055] Experimental study on the effect of the traditional Chinese medicine composition of the present invention on gastroesophageal reflux cough. 1. Establishment of a guinea pig model of gastroesophageal reflux cough Of the 64 guinea pigs, 8 were randomly selected as the blank control group, and the rest were used to create the model.

[0056] The modeling method was as follows: Except for the blank control group, guinea pigs in all other groups were fasted for 12 hours and then lightly anesthetized intraperitoneally with 2% sodium pentobarbital. A gastric tube was inserted into the lower esophagus through the oral cavity, and a disposable infusion set was connected to the gastric tube to infuse 0.1 mol / L hydrochloric acid at a rate of 8 drops / minute for 20 minutes, once daily for 14 consecutive days. After infusion, normal diet was provided.

[0057] After modeling, the guinea pigs were randomly divided into 7 groups according to their weight, with 8 animals in each group. These groups were the model control group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group.

[0058] Example 1 group: 7.25 g / kg of Example 1 decoction administered by gavage. Example 2 group: 7.25 g / kg of Example 2 decoction administered by gavage. Comparative Example 1 group: 7.25 g / kg of Comparative Example 1 decoction administered by gavage. Comparative Example 2 group: 7.25 g / kg of Comparative Example 2 decoction administered by gavage. Comparative Example 3 group: 7.25 g / kg of Comparative Example 3 decoction administered by gavage. Comparative Example 4 group: 7.25 g / kg of Comparative Example 4 decoction administered by gavage.

[0059] All drug dosages were calculated based on the amount of raw medicinal material. Guinea pigs in the blank control group and model control group were administered an equal volume of physiological saline by gavage at a dose of 10 mL / kg. Administration was once daily for 14 consecutive days.

[0060] 2. Indicator Testing Pulmonary capillary permeability measurement Guinea pigs were anesthetized by intraperitoneal injection of 0.1 mL / g of 2% sodium pentobarbital. 1 mg / kg of 2% Evans blue was injected via femoral vein. The guinea pigs were euthanized 15 minutes later. After thoracotomy, 10 mL of physiological saline was injected into the right ventricle at a constant rate to flush out the dye within the blood vessels. The lungs were removed, and after removing all surface moisture, their wet mass was weighed using an electronic balance. The lungs were then placed in 4 mL of formamide and incubated at 37°C for 24 hours to extract the dye from the tissue. The solution was filtered, and the OD value was read at 620 nm using a spectrophotometer. The amount of dye extracted was calculated using a standard curve, with the amount of dye extracted per unit tissue reflecting pulmonary capillary permeability.

[0061] Preparation of tracheal specimen pathological sections A 0.5 cm section of tissue from the trachea near the larynx was removed, fixed in 10% formaldehyde solution, dehydrated, embedded in paraffin, sectioned, stained with hematoxylin and eosin, and mounted with resin. The morphological features of the trachea were observed under a light microscope. The pathological grading of tracheal inflammation was based on the eight pathological indicators for small airways established by He Quanying et al.

[0062] 3. Statistical Methods Data processing was performed using Graphpad Prism 7.0 software. Quantitative data were expressed as mean ± standard deviation. This indicates that one-way ANOVA was used for comparisons among multiple groups, and pairwise comparisons between groups were performed using SNK-q, with P < 0.05 considered statistically significant.

[0063] 4. Experimental Results 4.1 Effects on tracheal tissue inflammation Compared with the blank control group, the tracheal tissue inflammation score of the model control group was significantly increased, indicating that the model was successfully established.

[0064] Compared with the model control group, the tracheal tissue inflammation scores of Example 1 group and Example 2 group were significantly reduced.

[0065] Compared with comparative groups 1-4, group 1 of Example 1 showed a significant difference in reducing the tracheal tissue inflammation score, as shown in the following figures. Figure 1 .

[0066] 4.2 Effects on lung tissue permeability Compared with the blank control group, the lung tissue permeability of the model control group was significantly increased.

[0067] Compared with the model control group, the lung tissue permeability of Example 1 group and Example 2 group was significantly reduced.

[0068] Compared with comparative groups 1-4, group 1 of Example 1 showed a significant difference in reducing lung tissue permeability, as shown in the results below. Figure 2 .

[0069] The herbal composition of this invention significantly reduces lung tissue permeability, reduces airway inflammation, and significantly improves symptoms of gastroesophageal reflux cough. The synergistic effect of multiple medicinal ingredients in the herbal composition of this invention achieves the therapeutic effect on gastroesophageal reflux cough.

[0070] Observation on the therapeutic effect of the traditional Chinese medicine composition of the present invention on gastroesophageal reflux cough I. Materials and Methods 1. Clinical Data Sixty patients with gastroesophageal reflux cough who presented to the hospital were randomly divided into two groups: a study group and a control group, with 30 patients in each group. The study group consisted of 20 males and 15 females, with an average age of 51.14 ± 9.56 years; the control group consisted of 19 males and 16 females, with an average age of 49.93 ± 10.27 years. There were no statistically significant differences in gender or age between the two groups.

[0071] 2. Case selection criteria Western medicine diagnostic criteria According to the relevant diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Cough (2015)": ① Coughing is more likely to occur when changing body position or standing upright, and is more common during the day. It can be aggravated by greasy or acidic foods, and is mainly a dry cough; ② Accompanying symptoms include acid reflux and retrosternal pain; ③ Imaging examination shows gastroesophageal reflux and inflammation; ④ Demeester score > 12.7 points; ⑤ Symptoms are significantly relieved or disappear after anti-reflux or acid-suppressing treatment.

[0072] Traditional Chinese Medicine Diagnosis Standards According to the relevant diagnostic criteria in the "Expert Consensus on the Diagnosis and Treatment of Cough in Traditional Chinese Medicine (2011 Edition)": Main symptoms: Paroxysmal choking cough, aggravated by eating or lying flat, vomiting of sour and bitter fluid; Secondary symptoms: Accompanied by burning pain, belching with a foul odor, acid regurgitation or heartburn, and daily upper abdominal discomfort; Tongue and pulse: thin white tongue coating, red tongue body, and wiry pulse.

[0073] 3. Inclusion criteria The patient meets the diagnostic criteria of Western medicine and the syndrome differentiation criteria of traditional Chinese medicine; has normal cognitive and communication abilities; has not received any other drug or surgical treatment in the past month; and is aged 20-70 years.

[0074] 4. Exclusion Criteria Individuals aged 20 or under, or 70 or over; pregnant or breastfeeding women; individuals with serious cardiovascular, liver, kidney, or hematopoietic system diseases, or mental illness; individuals with allergies or allergies to multiple medications.

[0075] 5. Treatment methods The study group took the decoction from Example 1 orally twice a day.

[0076] The control group received oral omeprazole magnesium enteric-coated tablets, 20 mg twice daily, before meals.

[0077] The efficacy was determined after both groups took the medication continuously for 4 weeks.

[0078] 6. Indicator Observation Daytime and nighttime cough symptom scores Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the daytime and nighttime cough symptoms of the two groups of patients before and after treatment were scored. The symptoms were scored as 0 points for none, 1 point for mild, 2 points for moderate, and 3 points for severe. The higher the score, the more severe the symptoms.

[0079] Efficacy assessment criteria Cured: Cough disappears, and the reduction rate of TCM syndrome score is >90%; Significantly effective: Cough is significantly relieved, and the reduction rate of TCM syndrome score is 70%-89%; Effective: Cough is somewhat relieved, and the reduction rate of TCM syndrome score is 30%-69%; Ineffective: Cough remains unchanged, and the reduction rate of TCM syndrome score is <30%.

[0080] Effectiveness rate = (cured + significantly effective + effective) / number of cases × 100%.

[0081] 7. Statistical Methods Data processing was performed using SPSS 17.0 software. Measurement data were expressed as mean ± standard deviation. The t-test was used for comparisons between groups, and the χ² test was used for count data. 2 The test showed that P < 0.05 was statistically significant.

[0082] II. Results 1. Comparison of daytime and nighttime cough symptom scores before and after treatment After treatment, the daytime and nighttime cough symptom scores of both groups were lower than before treatment, and the scores of the study group were lower than those of the control group after treatment, with statistically significant differences (P < 0.05). Results are shown below. Figure 3 , Figure 4 .

[0083] 2. Comparison of clinical efficacy The efficacy and total efficacy of the herbal composition of this invention are better than those of the control group, as shown in Table 1.

[0084] Table 1 Comparison of clinical efficacy between the two groups The above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description, and such obvious variations or modifications are still within the scope of protection of this invention.

Claims

1. A traditional Chinese medicine composition for treating gastroesophageal reflux cough, characterized in that, The traditional Chinese medicine composition for treating gastroesophageal reflux cough is made from the following raw materials: 7-12 parts of Inula japonica, 8-13 parts of Magnolia officinalis, 8-13 parts of Citrus reticulata peel, 12-18 parts of Poria cocos, 2-6 parts of Fritillaria cirrhosa, 8-13 parts of Citrus aurantium, 10-15 parts of Atractylodes macrocephala, and 8-13 parts of chicken gizzard lining.

2. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to claim 1, characterized in that, The traditional Chinese medicine composition for treating gastroesophageal reflux cough includes the following ingredients: 9 parts of Inula japonica, 10 parts of Magnolia officinalis, 10 parts of Citrus reticulata peel, 15 parts of Poria cocos, 3 parts of Fritillaria cirrhosa, 10 parts of Citrus aurantium, 12 parts of Atractylodes macrocephala, and 10 parts of chicken gizzard lining.

3. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to claim 1, characterized in that, The traditional Chinese medicine composition for treating gastroesophageal reflux cough includes the following ingredients: 12 parts of Inula japonica, 8 parts of Magnolia officinalis, 13 parts of Citrus reticulata peel, 12 parts of Poria cocos, 6 parts of Fritillaria cirrhosa, 13 parts of Citrus aurantium, 10 parts of Atractylodes macrocephala, and 8 parts of chicken gizzard lining.

4. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to claim 1, characterized in that, The traditional Chinese medicine composition for treating gastroesophageal reflux cough includes the following ingredients: 7 parts of Inula japonica, 13 parts of Magnolia officinalis, 8 parts of Citrus reticulata peel, 18 parts of Poria cocos, 2 parts of Fritillaria cirrhosa, 8 parts of Citrus aurantium, 15 parts of Atractylodes macrocephala, and 13 parts of chicken gizzard lining.

5. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to any one of claims 1-4, characterized in that, The preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux cough is as follows: weigh each medicinal material, mix them, soak them in water, decoct them, filter them, and combine the filtrates to obtain the traditional Chinese medicine composition decoction for treating gastroesophageal reflux cough.

6. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to any one of claims 1-4, characterized in that, The preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux cough is as follows: weigh each herb, soak for 30-50 minutes, decoct with purified water, decoct twice, add 500 mL of purified water each time, decoct for 30-60 minutes each time, concentrate the filtrate, combine the filtrates, and the decoction of the traditional Chinese medicine composition for treating gastroesophageal reflux cough is obtained.

7. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition for treating gastroesophageal reflux cough is prepared in the form of decoction, pills, gel, tablets, mixture, capsules, granules, powder, or ointment.

8. The traditional Chinese medicine composition for treating gastroesophageal reflux cough according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition for treating gastroesophageal reflux cough is prepared as a decoction.

9. The use of the traditional Chinese medicine composition for treating gastroesophageal reflux cough according to any one of claims 1-4 in the preparation of a medicine for preventing or treating gastroesophageal reflux cough.

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