Traditional Chinese medicine composition for treating gastroesophageal reflux

Abstract

The invention discloses a traditional Chinese medicine composition for treating gastroesophageal reflux. The invention belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition is prepared from rhizoma bletillae, bulbus fritillariae thunbergii, cuttlebone, calcined concha arcae, fructus amomi and the like. The traditional Chinese medicine composition has the effects of relieving hyperacidity and pain, and regulating qi and harmonizing stomach. The traditional Chinese medicine composition disclosed by the invention has an excellent clinical effect in treating the gastroesophageal reflux disease, is mild in medicine property of the whole formula, is suitable for various syndromes of the gastroesophageal reflux disease, and is particularly suitable for patients with heartburn, sour regurgitation and belching, chest distress, inappetence, vomiting, throat discomfort, light red tongue, white fur and slippery pulse caused by phlegm-heat and qi stagnation.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating gastroesophageal reflux. BACKGROUND

[0002] Gastro-esophageal reflux disease (GERD) refers to a disease of reflux-related symptoms and (or) complications caused by the reflux of gastric contents into the esophagus. The gastro-esophageal reflux disease can be divided into three types of non-erosive reflux disease (NERD), erosive esophagitis (EE) and Barrett's esophagus (BE). The pathogenesis of the gastro-esophageal reflux disease is the weakening of the defense mechanism and the decline of the esophageal acid clearance capacity, mainly manifested as the decrease of the lower esophageal sphincter pressure (LESP), excessive transient lower esophageal sphincter relaxation (tLESR) and the like. The main damage factor of the gastro-esophageal reflux disease is the excessive reflux of gastric contents (mainly gastric acid) into the esophagus, which causes esophageal mucosal injury, and bile and digestive enzymes can also cause esophageal mucosal injury. The gastro-esophageal reflux disease has various clinical manifestations. Heartburn and acid reflux are the most common typical symptoms, and chest pain is also a common symptom. Other atypical symptoms include upper abdominal pain, stomach distension, belching, nausea and other dyspeptic symptoms, or accompanied by throat discomfort, dysphagia, sleep disorders, chronic cough, bronchial asthma, chronic laryngitis, dental erosion and the like. Complications include upper gastrointestinal bleeding, esophageal stenosis and the like. The above symptoms can be caused by improper diet, emotional stimulation, fatigue and climate change and the like. Some patients are also accompanied by mental tension, irritability, emotional depression, insomnia, palpitation, amnesia and the like, which in turn can aggravate the symptoms of the gastro-esophageal reflux disease, form a vicious cycle, complicate the disease and make it difficult to cure.

[0003] Traditional Chinese medicine believes that the causes of gastroesophageal reflux disease (GERD) include: exposure to external pathogens, cold or heat affecting the stomach; emotional distress and excessive thinking; irregular diet and excessive smoking and drinking; pre-existing gallbladder disease, gallbladder pathogens invading the stomach; and congenital deficiency and spleen and stomach weakness. Congenital deficiency and spleen and stomach weakness are the basic pathogenesis of GERD. When the earth element is deficient, the wood element overacts or the wood element is stagnant and the earth element is obstructed, the wood element becomes unrestrained and uncontrolled. The liver wood element overacts on the spleen earth element, and the gallbladder wood element counteracts the stomach earth element, leading to disharmony between the liver and stomach, liver and spleen, or gallbladder and stomach. When qi stagnation persists, it transforms into fire and produces acid. The evil heat of the liver and gallbladder invades the spleen and stomach, the spleen qi fails to ascend and the stomach qi fails to descend. The liver qi does not follow the spleen qi to ascend and the gallbladder qi does not follow the stomach qi to descend, so the stomach qi rises with fire and heat. The liver fire rises and insults the lungs, damaging the lung metal element, consuming body fluids, and the lungs lose their descending function, resulting in cough and shortness of breath. The qi mechanism is impaired, and phlegm and qi stagnate in the chest and diaphragm. When the disease progresses, the qi disease affects the blood, leading to blood stasis due to deficiency or qi stagnation and blood stasis. Currently, the treatment goals for gastroesophageal reflux disease (GERD) are to cure esophagitis, relieve symptoms, improve quality of life, and prevent complications. Treatment includes the following aspects: 1) Lifestyle modifications. Lifestyle changes such as elevating the head of the bed, avoiding eating 3 hours before bedtime, avoiding high-fat foods, quitting smoking and alcohol, and losing weight may benefit some GERD patients, but these changes are insufficient to control symptoms for most. 2) Drug therapy. Acid-suppressing drugs, which inhibit gastric acid secretion, are currently the basic method for treating GERD. Drugs that inhibit gastric acid include H2 receptor antagonists (H2RAs) and PPIs. Although these drugs can effectively relieve symptoms to some extent, long-term use can cause adverse reactions such as diarrhea, nausea, and dizziness, increase drug tolerance and dependence, and also increase the risk of infection and affect gastric acid secretion function. 3) Surgical treatment. Antireflux surgery is as effective as drug therapy in relieving symptoms and healing esophagitis. The incidence of surgical complications and mortality is closely related to the surgeon's experience and skill level.

[0004] Currently, the treatment of gastroesophageal reflux disease (GERD) with traditional Chinese medicine requires differentiation of syndromes based on the specific symptoms of each patient, thus enabling specific medication. Clinically, there is a lack of well-established Chinese medicine formulas that can be widely applied to the treatment of GERD for various patients. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating gastroesophageal reflux disease (GERD). The technical solution of this invention optimizes the compatibility ratio of raw materials and the preparation process, providing a traditional Chinese medicine composition with significant improvement effects for various syndromes of GERD, especially the typical symptoms caused by phlegm-heat and qi stagnation. Furthermore, through scientific formula design and advanced preparation processes, this invention provides a traditional Chinese medicine composition for treating GERD that is highly effective, safe, and widely applicable, filling the gap in existing technologies for widely used prepared traditional Chinese medicine formulas, and possessing significant clinical value and market prospects.

[0006] In order to achieve the above object, the technical scheme adopted by the present application is as follows: A traditional Chinese medicine composition for treating gastroesophageal reflux, which comprises the following components in parts by weight: 10-24 parts of white and 5-10 parts of Zhebei, 10-20 parts of sea squirt, 10-30 parts of calcined walnut fruit, and 3-9 parts of sand ginger.

[0007] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 12-24 parts of white and 9-10 parts of Zhebei, 10-15 parts of sea squirt, 15-30 parts of calcined walnut fruit, and 6-9 parts of sand ginger.

[0008] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of white and 10 parts of Zhebei, 10 parts of sea squirt, 15 parts of calcined walnut fruit, and 6 parts of sand ginger.

[0009] The present application also provides a preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux, which comprises the following steps:

[0010] (1) White and Zhebei, sea squirt, calcined walnut fruit and sand ginger are respectively weighed according to the specified weight ratio and are preliminarily processed;

[0011] (2) White and Zhebei are mixed and then are placed in an ultrasonic extractor, deionized water with a volume ratio of 1:5-1:10 is added, and the first extraction liquid is obtained by extraction under the conditions of an ultrasonic power of 400-600 W and a temperature of 40-60 ℃ for 30-60 minutes;

[0012] (3) Sea squirt and calcined walnut fruit are mixed and then are added with an ethanol solution with a volume ratio of 1:3-1:5, the second extraction liquid is obtained by stirring under the conditions of a stirring speed of 200-400 rpm and a temperature of 30-50 ℃ for 20-40 minutes, and then is filtered;

[0013] (4) Sand ginger is placed in a sealed container, distilled water with a volume ratio of 1:2-1:4 is added, and the third extraction liquid is obtained by heating to 80-90 ℃ and keeping for 10-20 minutes, and then is cooled;

[0014] (5) The first extraction liquid, the second extraction liquid and the third extraction liquid are mixed uniformly, and then are concentrated to a relative density of 1.10-1.20 by using a vacuum concentration technology under the conditions of a temperature of 50-70 ℃ and a vacuum degree of -0.08 to -0.1 MPa;

[0015] (6) The obtained extract is mixed with appropriate excipients, and then is subjected to spray drying treatment to obtain a powder-shaped traditional Chinese medicine composition.

[0016] Preferably, the working condition parameters of the ultrasonic extractor include an ultrasonic power of 450-550 W, an extraction time of 40-50 minutes, and an extraction temperature of 45-55 ℃.

[0017] Preferably, the working condition parameters of the stirring device include: a stirring speed of 250-350 rpm, a stirring time of 25-35 minutes, and a stirring temperature of 35-45 DEG C.

[0018] Preferably, the working condition parameters of the vacuum concentration device include: a concentration temperature of 55-65 DEG C, and a vacuum degree of -0.09 to -0.1 MPa.

[0019] Preferably, the working condition parameters of the spray drying device include: an air inlet temperature of 150-170 DEG C, and an air outlet temperature of 60-80 DEG C.

[0020] The application also provides a use of the traditional Chinese medicine composition for treating gastroesophageal reflux, wherein the traditional Chinese medicine composition is prepared into granules, capsules or powders, and is taken 2-3 times per day, with a dosage of 3-5 grams each time, which can be adjusted according to the patient's condition.

[0021] The application has the following beneficial effects: (1) the traditional Chinese medicine composition has good curative effect, which is verified by long-term clinical practice, and the dosage ratio is limited, so that significant technical progress is achieved, which is related to cost reduction, curative effect improvement, side effect reduction, patient compliance improvement and the like; (2) the traditional Chinese medicine composition has the effects of astringing and hemostasis by white, protecting gastric mucosa, clearing heat and reducing phlegm by Zhebei, eliminating inflammation and resolving masses, relieving pain and astringing by sea squirt, softening and resolving masses, hemostasis and eliminating stasis by calcined Wanezi, regulating qi and stomach, invigorating spleen and stomach, and the like, so that a compatibility system of cold and heat combination and ascending and descending coordination is formed; the compatibility design can comprehensively regulate the function of spleen and stomach, relieve various symptoms of gastroesophageal reflux disease, and is especially suitable for heartburn, acid regurgitation, chest distress, loss of appetite and the like caused by phlegm-heat and qi stagnation; (3) the application finds the optimal weight ratio according to clinical practice, so that the whole prescription has reasonable compatibility of monarch, minister, assistant and guide, and has optimal therapeutic effect. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 Comparison chart of GERD-Q scale total scores;

[0023] Figure 2 Comparison chart of TCM syndrome total scores.

[0024] The accompanying drawings are included to provide a further understanding of the application, and constitute a part of the specification, illustrate the application, and together with the embodiments serve to explain the principle of the application, and do not constitute a limitation of the application. DETAILED DESCRIPTION

[0025] Clearly, the embodiments described are only a part of the embodiments of the present application, rather than all the embodiments; based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art. Any methods and materials similar or equivalent to those described herein can be used in the practice of the present application. The described preferred methods and materials are only examples of the methods and materials that can be used.

[0027] The experimental methods in the following examples are all conventional methods unless otherwise specified; the experimental materials and experimental strains used in the following examples are all purchased from commercial channels unless otherwise specified.

[0028] Example 1

[0029] A traditional Chinese medicine composition for treating gastroesophageal reflux

[0030] The traditional Chinese medicine composition comprises the following components by weight: 15 parts of white bletilla, 10 parts of Zhebei, 10 parts of sea squid, 15 parts of calcined walnut, and 6 parts of amomum villosum.

[0031] The present application also provides a preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux, which comprises the following steps:

[0032] (1) white bletilla, Zhebei, sea squid, calcined walnut and amomum villosum are respectively weighed according to the specified weight ratio and are preliminarily treated;

[0033] (2) after mixing white bletilla and Zhebei, they are placed in an ultrasonic extractor, deionized water with a volume ratio of 1:8 is added, and the first extraction liquid is obtained under the conditions of ultrasonic power of 500 W and temperature of 50℃ for 45 minutes;

[0034] (3) after mixing sea squid and calcined walnut, ethanol solution with a volume ratio of 1:4 is added, and the second extraction liquid is obtained after stirring at a stirring speed of 300 rpm and a temperature of 40℃ for 30 minutes and filtering;

[0035] (4) amomum villosum is placed in a sealed container alone, distilled water with a volume ratio of 1:3 is added, heated to 82℃ and kept for 15 minutes, then taken out and cooled to obtain the third extraction liquid;

[0036] (5) mixing the first extract, the second extract and the third extract uniformly, and then using a vacuum concentration technology to concentrate the mixture to a relative density of 1.15 at a temperature of 60 DEG C and a vacuum degree of -0.09 MPa;

[0037] (6) mixing the obtained extract with appropriate excipients, and then performing a spray drying treatment to obtain a powder-shaped traditional Chinese medicine composition.

[0038] The working condition parameters of the ultrasonic extractor include that the ultrasonic power is 500 W, the extraction time is 45 minutes, and the extraction temperature is 50 DEG C.

[0039] The working condition parameters of the stirring equipment include that the stirring speed is 300 rpm, the stirring time is 30 minutes, and the stirring temperature is 40 DEG C.

[0040] The working condition parameters of the vacuum concentration equipment include that the concentration temperature is 60 DEG C, and the vacuum degree is -0.05 MPa.

[0041] The working condition parameters of the spray drying equipment include that the air inlet temperature is 160 DEG C, and the air outlet temperature is 70 DEG C.

[0042] The application further provides a use of the traditional Chinese medicine composition for treating gastroesophageal reflux.

[0043] Example 2

[0044] A traditional Chinese medicine composition for treating gastroesophageal reflux

[0045] The traditional Chinese medicine composition comprises the following components in parts by weight: 18 parts of white, 10 parts of Zhebei, 20 parts of sea squirt, 15 parts of calcined walnut, and 6 parts of sand ginger.

[0046] The application further provides a preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux.

[0047] Example 3

[0048] A traditional Chinese medicine composition for treating gastroesophageal reflux

[0049] The traditional Chinese medicine composition comprises the following components in parts by weight: 24 parts of white, 9 parts of Zhebei, 20 parts of sea squirt, 30 parts of calcined walnut, and 6 parts of sand ginger.

[0050] The application further provides a preparation method of the traditional Chinese medicine composition for treating gastroesophageal reflux.

[0051] Example 4

[0052] A traditional Chinese medicine composition for treating gastroesophageal reflux.

[0053] The traditional Chinese medicine composition comprises the following components in parts by weight: 12 parts of Bletilla striata, 10 parts of Fritillaria thunbergii, 15 parts of Cuttlebone, 15 parts of Calcined Ostrea gigas, and 9 parts of Amomum villosum.

[0054] The present invention also provides a method for preparing a traditional Chinese medicine composition for treating gastroesophageal reflux, wherein the preparation method is performed in accordance with Example 1.

[0055] Experimental Example 1

[0056] The therapeutic effect of a traditional Chinese medicine composition for treating gastroesophageal reflux.

[0057] 1. Sample: Among the 120 patients, the age ranged from 24 to 75 years, the duration of disease was mostly from 3 months to 10 years, and the average age was 51 years.

[0058] 2. Diagnostic criteria:

[0059] Western medicine diagnostic criteria: The criteria are based on the "Chinese Consensus Opinion on Gastroesophageal Reflux Disease (2014)" and the "Chinese Consensus Opinion on Gastroesophageal Reflux Disease (2007)": If the patient meets the typical symptoms of heartburn and reflux, and there is no evidence of gastrointestinal obstruction, the patient can be clinically diagnosed with GERD.

[0060] Traditional Chinese Medicine (TCM) diagnostic criteria: Based on the standards established in the "Expert Consensus on the Diagnosis and Treatment of Gastroesophageal Reflux Disease with Traditional Chinese Medicine (2017)".

[0061] Liver and stomach heat stagnation syndrome: heartburn and acid reflux are the main symptoms; burning pain behind the sternum, abdominal distension, and irritability are the secondary symptoms; red tongue with yellow coating, and wiry pulse.

[0062] Gallbladder heat invading the stomach syndrome: bitter taste in the mouth, dry throat, and heartburn are the main symptoms; distending pain in the hypochondrium, irritability, and insomnia are the secondary symptoms; red tongue with yellow and greasy coating, and wiry and slippery pulse.

[0063] Qi stagnation and phlegm obstruction syndrome: The main symptoms are a feeling of phlegm obstruction in the throat and discomfort in the chest; secondary symptoms are belching and difficulty swallowing; the tongue coating is white and greasy, and the pulse is wiry and slippery.

[0064] Blood stasis obstructing the collaterals syndrome: The main symptom is burning or stabbing pain behind the sternum; the secondary symptoms are back pain, hematemesis and melena; the tongue is dark purple with ecchymosis, and the pulse is choppy.

[0065] The main symptoms of deficiency of the middle jiao and rebellious qi are acid reflux, regurgitation of clear water, and belching; secondary symptoms include dull pain in the stomach and fatigue; the tongue is pale with a thin coating and the pulse is thready and weak.

[0066] Spleen deficiency with damp-heat syndrome: The main symptoms are acid reflux and bloating after meals; the secondary symptoms are burning pain in the stomach and fatigue; the tongue is pale red with a thin yellow and greasy coating, and the pulse is thready, slippery and rapid.

[0067] Inclusion criteria: Patients meeting both traditional Chinese medicine and Western medicine diagnostic criteria, aged 18-75 years, who signed informed consent forms and cooperated with follow-up. Exclusion criteria: Patients with severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, malignant tumors, mental illnesses, or other conditions that could affect the safety of the study.

[0068] 3. Treatment methods:

[0069] A randomized controlled clinical trial was conducted, randomly assigning 120 patients to either a traditional Chinese medicine (TCM) group or a Western medicine group. The TCM group received the basic formula of Jibei Haiwa Decoction prepared in Example 1 of this invention (Baiji 15g, Zhebei 10g, Haipiaoxiao 10g, calcined oyster shell 15g, Amomum villosum 6g), one dose daily, taken twice daily on an empty stomach, for a course of 4 weeks. The Western medicine group received esomeprazole enteric-coated tablets 20mg twice daily, 30 minutes before meals, for a course of 4 weeks.

[0070] 4. Treatment results:

[0071] Treatment evaluation criteria; Gerd Q scale, Traditional Chinese Medicine syndrome scoring scale.

[0072] Results analysis: such as Figure 1 As shown, before treatment, the baseline levels of the Gerd Q scale in the traditional Chinese medicine group and the Western medicine group were similar. After 4 weeks of treatment, the score in the traditional Chinese medicine group decreased to 6.65±1.02 points, and the score in the Western medicine group decreased to 6.08±0.95 points. Intra-group comparisons showed statistically significant differences before and after treatment in both the traditional Chinese medicine group and the Western medicine group. Figure 2 As shown, before treatment, the baseline levels of the total TCM syndrome scores in the two groups were similar. After 4 weeks of treatment, the score in the TCM group decreased to 4.21±1.56 points, while that in the Western medicine group decreased to 5.67±1.89 points. Intra-group comparisons showed statistical significance in the TCM group before and after treatment. Further analysis of the improvement in individual symptoms revealed that the TCM group showed a more significant improvement advantage over the Western medicine group in core symptoms such as epigastric burning sensation, frequency of belching, and degree of loss of appetite, especially in alleviating symptoms of phlegm-heat stagnation syndrome such as chest tightness, shortness of breath, and throat discomfort (P<0.01). The results showed that the efficacy of Jibei Haiwa Decoction in treating GERD was comparable to that of esomeprazole, while Jibei Haiwa Decoction demonstrated advantages in improving the overall TCM syndrome of patients. Jibei Haiwa Decoction is mild in nature, possessing astringent, acid-neutralizing, stomach-harmonizing, and nausea-reducing effects, making it suitable for treating various syndrome types of gastroesophageal reflux disease. By adjusting the formula according to individual symptoms, it can specifically regulate the pathological state of different patients, better regulating the functional state of their internal organs.

[0073] Experimental Example 2

[0074] Typical clinical cases

[0075] Clinical Case 1

[0076] Name: Li Moumou

[0077] Age: 25

[0078] Gender: Male

[0079] Complaint: Acid regurgitation and heartburn for more than 3 years, aggravated for 1 month

[0080] Present illness: The patient has acid regurgitation and heartburn, especially at night, warm air, and obvious after meals. He has dry mouth, bitter taste, poor appetite, cold preference, and normal urination and defecation.

[0081] Past history: The patient has no history of chronic diseases such as hypertension and diabetes.

[0082] Allergy history: The patient denies food and drug allergies.

[0083] Examination: The abdomen is soft, and there is no tenderness or rebound tenderness. There is no percussion pain in the liver and kidney areas.

[0084] Auxiliary examination: No gastrointestinal endoscopy results are available.

[0085] TCM diagnosis: Acid regurgitation and heartburn due to phlegm-heat and qi stagnation

[0086] Western medical diagnosis: Gastroesophageal reflux disease

[0087] Treatment: Clearing heat, reducing phlegm, regulating qi, and harmonizing the stomach

[0088] Prescription: Ji Bei Haixiawang Decoction (Baiji 15g, Zhebei 9g, Haixiaoke 10g, Chuanwalengzi 15g, Sharen 6g)

[0089] 7 doses, decocted in water, taken once a day, in two doses.

[0090] After 1 week of treatment, the patient returned for a follow-up visit:

[0091] The patient's acid regurgitation and heartburn symptoms were significantly reduced, from 5-6 episodes per day to 2-3 episodes. The retrosternal pain was relieved, the belching frequency was reduced, and the throat discomfort was alleviated. The tongue coating changed from white and greasy to thin white, and the pulse was more moderate than before. Chuanwalengzi was changed to 30g, and Haixiaoke was changed to 20g, and the patient continued to take the medicine for another week.

[0092] After 2 weeks of treatment, the patient returned for a follow-up visit:

[0093] The patient's heartburn only occurred occasionally after eating too much, and the acid regurgitation was significantly reduced. The chest tightness was basically gone, the appetite improved, and the sleep was more restful. The tongue was pale red, the coating was thin and white, and the pulse was stringy and slippery to stringy and slow. Chuanwalengzi was changed to 15g, and Haixiaoke was changed to 10g, and the patient continued to take the medicine for another 2 weeks.

[0094] After 4 weeks of treatment, the patient returned for a follow-up visit:

[0095] The patient's acid regurgitation and heartburn symptoms were basically gone, with only occasional mild belching. The chest tightness and throat discomfort were completely relieved, the appetite returned to normal, and the sleep quality improved significantly. The tongue was pale red, the coating was thin and white, and the pulse was even. The patient took the medicine for another week to consolidate the effect and then stopped taking it.

[0096] Case summary: The patient is a typical phlegm-heat and qi-stagnation type of gastroesophageal reflux disease. The Beihaiva Decoction targets the pathogenesis of the disease, with Zhebeimu clearing heat and reducing phlegm, Sharen regulating qi and harmonizing the stomach, Haipiao and Chuanwalengzi resolving acid and protecting the esophageal mucosa, and Baiji astringing and promoting tissue regeneration. The combination of these herbs achieves good results, demonstrating the advantages of Chinese medicine syndrome differentiation and treatment.

[0097] Clinical Case 2

[0098] Name: Li

[0099] Age: 33 years old

[0100] Gender: Male

[0101] Chief complaint: Burning discomfort in the epigastric region for more than 6 months, accompanied by cough and worsening at night

[0102] History: The patient experienced a burning sensation in the epigastric region after meals without obvious provocation 6 months ago. The pain was persistent and dull, radiating to the posterior sternum and back. The symptoms were most pronounced 30 minutes to 2 hours after meals and worsened at night. The patient also experienced cough, with thick and white sputum that was difficult to expectorate. The cough at night affected sleep, and the patient occasionally experienced belching. There was no significant acid reflux, and the patient experienced a decrease in appetite and occasional chest tightness. There was no significant change in body weight. The symptoms gradually worsened over the past 2 months, with significant burning discomfort and cough at night affecting rest. The patient had taken stomach medication without significant improvement. The tongue was pale red with a white and greasy coating, and the tongue body was large with tooth marks. The pulse was wiry and slippery.

[0103] Past medical history: The patient has a history of chronic gastritis and denies a history of hypertension, diabetes, heart disease, or surgical trauma.

[0104] Examination: The abdomen was soft without tenderness or rebound tenderness. There was no percussion pain in the liver or kidney areas.

[0105] Auxiliary examination: Gastroscopy showed reflux esophagitis (LA-A grade) and chronic superficial gastritis with bile reflux.

[0106] Chinese medical diagnosis: Acid regurgitation with phlegm-heat and qi-stagnation

[0107] Western medical diagnosis: 1. Gastroesophageal reflux disease, 2. Reflux esophagitis

[0108] Treatment principle: Clearing heat, reducing phlegm, regulating qi, harmonizing the stomach, resolving acid, and reducing adverse flow

[0109] Prescription: Beihaiva Decoction (Baiji 15g, Zhebeimu 9g, Haipiao 10g, Chuanwalengzi 15g, Sharen 6g, Gualou 15g, Jiegeng 9g)

[0110] 14 doses, decocted in water and taken once a day, divided into two doses.

[0111] Reexamination after 2 weeks of treatment:

[0112] The patient's stomach burning symptoms were significantly reduced, from persistent to intermittent, and the symptoms at night were reduced by 50%. The frequency of cough and sticky sputum was significantly reduced, and belching was improved. The tongue coating turned from white and greasy to thin white, and the pulse was stringy and slippery. Remove the Cane and Melon, and continue to take 2 weeks.

[0113] After 4 weeks of treatment, the patient returned for a follow-up:

[0114] The stomach burning sensation was basically gone, the night symptoms were completely relieved, the cough was occasional, the appetite was restored, the sleep quality was significantly improved, and the quality of life was significantly improved. The tongue was pale red, the coating was thin and white, and the pulse was smooth. The original prescription was taken for another week to consolidate the effect before stopping medication.

[0115] Case summary: This case of gastroesophageal reflux disease presented with stomach burning, night exacerbation, cough with sticky sputum, chest tightness, white and greasy tongue coating, and stringy and slippery pulse. The syndrome was acid regurgitation with phlegm-heat and qi stagnation. Treatment with self-made and Beihaiwa Decoction for clearing heat, reducing phlegm, regulating qi, and stomach, and for acid reduction and reverse, combined with Cane and Melon for lung expansion and phlegm elimination, and Melon for heat-clearing and phlegm-reducing to widen the chest, so that phlegm-heat is cleared and qi movement is smooth. After 4 weeks, the symptoms disappeared, indicating that in the treatment of gastroesophageal reflux disease, attention should be paid to the phlegm-heat and qi stagnation type. On the basis of acid protection and stomach protection, the combination of phlegm-heat and qi stagnation can significantly improve the clinical efficacy.

[0116] Clinical Case 3

[0117] Name: Li Moumou

[0118] Age: 44 years old

[0119] Gender: Male

[0120] Complaint: Stomach fullness with acid regurgitation and heartburn for more than 10 years, aggravated after meals.

[0121] History: The patient began to have postprandial stomach fullness and acid regurgitation and heartburn more than 10 years ago. The symptoms worsened over the years. Present symptoms include stomach fullness and pain, which occurs 30 minutes after meals and lasts for 2-3 hours, accompanied by acid regurgitation and heartburn, dry mouth and bitter taste, frequent belching, occasional nausea, poor appetite for hot food, mental fatigue, and restless sleep. The two excrements are still adjusted. She has taken western medicine many times, but the symptoms are recurrent.

[0122] Past history: 8 years of history of chronic gastritis, no history of other chronic diseases.

[0123] Examination: Abdominal soft, no abdominal tenderness and rebound tenderness, no percussion pain in liver and kidney area.

[0124] Auxiliary examination: Gastroscopy: reflux esophagitis (LA-B~C), esophageal hiatus hernia, chronic superficial gastritis.

[0125] TCM diagnosis: acid regurgitation with phlegm-heat and qi stagnation

[0126] Western medicine diagnosis: 1. Gastroesophageal reflux disease, 2. Reflux esophagitis, 3. Esophageal hiatal hernia

[0127] Treatment: warming the middle and invigorating the spleen, resolving phlegm and regulating qi, regulating acid and protecting the stomach

[0128] Prescription: Ji Bei Haiwa Decoction (Bletilla striata 15g, Spatholobi 9g, Concha Arcae 10g, Calcined Fructus Schisandrae 15g, Amomum 6g, Coptis 6g, Evodia 2g, Ginger and Magnolia Officinalis 12g, Inula 30g)

[0129] 14, decoction, one dose a day, two times a day.

[0130] After 2 weeks of treatment:

[0131] The patient's belching and nausea were significantly reduced, the fullness in the stomach was significantly reduced, the appetite was restored, and the mental state was improved. The tongue coating turned from white and greasy to thin white, and the pulse turned from deep and slippery to fine and slow. Calcined Fructus Schisandrae was changed to 30g, and the treatment was continued for another 2 weeks.

[0132] After 4 weeks of treatment:

[0133] The patient's fullness in the stomach, acid reflux and heartburn symptoms disappeared, belching occasionally, appetite returned to normal. The complexion turned moist, the tongue was pale red, the coating was thin and white, and the pulse was smooth. Calcined Fructus Schisandrae was changed to 15g, and Coptis, Evodia, Ginger and Magnolia Officinalis, and Inula were removed, and the treatment was continued for another week to consolidate the effect.

[0134] Case summary: This case is a patient with gastroesophageal reflux disease with esophageal hiatal hernia, with a course of more than 10 years. The symptoms include fullness in the stomach, acid reflux and heartburn, dry mouth and bitter taste, frequent belching, and preference for hot food. The syndrome is cold and heat mixed, phlegm and qi mutual knot. Treatment uses Ji Bei Haiwa Decoction plus Coptis and Evodia to regulate cold and heat, and Ginger and Magnolia Officinalis to resolve phlegm and reduce reverse distension. The original prescription is combined with stomach-protecting drugs to treat both the symptoms and the root cause. After 4 weeks, all symptoms disappeared, which shows that the complex pathogenesis of gastroesophageal reflux disease requires dialectical treatment. The use of cold and heat together and the method of resolving phlegm and reducing reverse can achieve satisfactory results for the cold and heat mixed type.

[0135] Although embodiments of the present application have been shown and described, it is to be understood that various modifications, substitutions, replacements and changes can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

[0136] The above describes the present application and its embodiments, which is not restrictive, and the drawings only show one of the embodiments of the present application, and the actual structure is not limited to this. In general, if a person skilled in the art is inspired, without departing from the purpose of the present application, without creative design, similar structure and embodiments of the technical solution can be obtained, which should belong to the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating gastroesophageal reflux, characterized in that: The raw materials include the following parts by weight: Bletilla striata 10-24 parts, Fritillaria thunbergii 5-10 parts, Cuttlebone 10-20 parts, Calcined Ostrea gigas 10-30 parts, and Amomum villosum 3-9 parts.

2. The traditional Chinese medicine composition for treating gastroesophageal reflux according to claim 1, characterized in that: The raw materials include the following parts by weight: Bletilla striata 12-24 parts, Fritillaria thunbergii 9-10 parts, Cuttlebone 10-15 parts, Calcined Ostrea gigas 15-30 parts, and Amomum villosum 6-9 parts.

3. The traditional Chinese medicine composition for treating gastroesophageal reflux according to claim 2, characterized in that: The raw materials include the following parts by weight: Bletilla striata 15 parts, Fritillaria thunbergii 10 parts, Cuttlebone 10 parts, Calcined Ostrea gigas 15 parts, and Amomum villosum 6 parts.

4. The method for preparing the traditional Chinese medicine composition for treating gastroesophageal reflux according to claims 1-3, characterized in that: The preparation method includes the following steps: (1) Weigh out Bletilla striata, Fritillaria thunbergii, Cuttlebone, Calcined Oyster Shell and Amomum villosum according to the prescribed weight proportions and perform preliminary processing; (2) Mix Bletilla striata and Fritillaria thunbergii and place them in an ultrasonic extractor. Add deionized water with a volume ratio of 1:5 to 1:10 and extract for 30 to 60 minutes under ultrasonic power of 400 to 600W and temperature of 40 to 60℃ to obtain the first extract. (3) After mixing cuttlebone and calcined oyster shell, add an ethanol solution with a volume ratio of 1:3 to 1:

5. Stir for 20 to 40 minutes at a stirring speed of 200 to 400 rpm and a temperature of 30 to 50°C. Filter to obtain the second extract. (4) Place the cardamom in a sealed container, add distilled water with a volume ratio of 1:2 to 1:4, heat to 80 to 90°C and maintain for 10 to 20 minutes, then remove and cool to obtain the third extract. (5) After the first extract, the second extract and the third extract are mixed evenly, the extract is concentrated to a relative density of 1.10 to 1.20 by vacuum concentration technology at a temperature of 50 to 70°C and a vacuum degree of -0.08 to -0.1 MPa. (6) After mixing the obtained extract with an appropriate amount of excipients, the mixture is spray-dried to obtain a powdered traditional Chinese medicine composition.

5. The method for preparing a traditional Chinese medicine composition for treating gastroesophageal reflux according to claim 4, characterized in that: The operating parameters of the ultrasonic extractor include: ultrasonic power of 450-550W, extraction time of 40-50 minutes, and extraction temperature of 45-55℃.

6. The method for preparing a traditional Chinese medicine composition for treating gastroesophageal reflux according to claim 5, characterized in that: The operating parameters of the stirring equipment include: stirring speed of 250-350 rpm, stirring time of 25-35 minutes, and stirring temperature of 35-45℃.

7. A method for preparing a traditional Chinese medicine composition for treating gastroesophageal reflux according to claim 6, characterized in that: The operating parameters of the vacuum concentration equipment include: concentration temperature of 55-65℃ and vacuum degree of -0.09--0.1MPa.

8. The method for preparing a traditional Chinese medicine composition for treating gastroesophageal reflux according to claim 7, characterized in that: The operating parameters of the spray drying equipment include: inlet air temperature of 150-170℃ and outlet air temperature of 60-80℃.

9. A traditional Chinese medicine composition for treating gastroesophageal reflux according to claims 1-3, characterized in that: The above-mentioned traditional Chinese medicine composition can be made into granules, capsules or powders.

10. The use of the traditional Chinese medicine composition according to claims 1-3 in the preparation of a medicine for treating gastroesophageal reflux disease with TCM syndromes of liver and stomach heat stagnation, gallbladder heat invading the stomach, qi stagnation and phlegm obstruction, blood stasis obstructing the collaterals, deficiency of the middle jiao and qi reversal, or spleen deficiency and damp heat.

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