Traditional Chinese medicine composition for treating gastroesophageal reflux disease, pharmaceutical preparation and preparation method and use

Abstract

The application discloses a traditional Chinese medicine composition for treating gastroesophageal reflux disease, a medicine preparation, a preparation method and application. The traditional Chinese medicine composition is prepared from raw medicinal materials, including 3-10 parts by weight of Radix Bupleuri, 3-10 parts by weight of Radix Paeoniae Alba, 3-10 parts by weight of Rhizoma Cyperi, 3-10 parts by weight of Radix Angelicae Pubescentis, 3-10 parts by weight of Atractylodes Rhizome, 3-10 parts by weight of Herba Taraxaci, 1-5 parts by weight of Rhizoma Coptidis, 1-4 parts by weight of Fructus Evodiae, 4-12 parts by weight of Fritillariae Thunbergii Miq, 3-10 parts by weight of Rhizoma Pinelliae, 4-12 parts by weight of Bamboo Shrub, 4-12 parts by weight of Jianqu, 3-10 parts by weight of Rhizoma Atractylodis Macrocephalae, 3-10 parts by weight of Fructus Aurantii, and 1-5 parts by weight of Radix Glycyrrhizae. The traditional Chinese medicine composition has the effects of soothing liver and stomach and reducing adverse flow and stopping vomiting, and is remarkably effective in treating gastroesophageal reflux disease of liver-stomach disharmony syndrome, and has a low recurrence rate.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, pharmaceutical preparation, and uses for treating gastroesophageal reflux disease. Background Technology

[0002] Gastroesophageal reflux disease (GERD) refers to a series of symptoms and complications caused by the reflux of stomach contents into the esophagus. It mainly includes three types: non-erosive reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus. Among these, non-erosive reflux disease (NERD) is a clinical syndrome characterized by typical gastroesophageal reflux symptoms (such as heartburn and acid reflux) but without endoscopic findings of esophageal mucosal damage, accounting for approximately 60%–70% of GERD patients.

[0003] The pathogenesis of NERD is complex, involving lower esophageal sphincter dysfunction, esophageal acid exposure, esophageal hypersensitivity, delayed gastric emptying, and psychological factors.

[0004] Currently, the first-line treatment for NERD in Western medicine is proton pump inhibitors (PPIs), such as omeprazole and rabeprazole. However, clinical practice shows that PPIs are significantly less effective for NERD patients than for patients with reflux esophagitis (RE), with a symptom relief rate of only 50%–60%. Furthermore, the relapse rate after discontinuation of the medication is high, and long-term use may lead to adverse reactions such as osteoporosis and intestinal flora imbalance.

[0005] Traditional Chinese medicine has demonstrated unique advantages in the treatment of NERD.

[0006] CN115282256A discloses a traditional Chinese medicine composition for treating digestive tract diseases, made from the following raw materials in parts by weight: Bupleurum chinense 3-15 parts, Cyperus rotundus 6-18 parts, Citrus aurantium 6-18 parts, Inula japonica 6-18 parts, Hematite 9-21 parts, Coptis chinensis 1-5 parts, Evodia rutaecarpa 1-5 parts, Gardenia jasminoides (roasted) 3-15 parts, Calcined oyster shell 20-40 parts, Mother-of-pearl 9-21 parts, Corydalis yanhusuo 3-15 parts, Polygonatum sibiricum 9-21 parts, and Zingiber officinale (fresh). This traditional Chinese medicine composition contains a large amount of mineral drugs such as hematite, calcined oyster shell, and mother-of-pearl, which are primarily sedatives and treat the symptoms; long-term use of these minerals can easily damage the spleen and stomach. Only the roasted Gardenia jasminoides clears heat; there are no expectorants or membrane-protecting agents, resulting in weak improvement for esophageal inflammation, excessive phlegm, and throat discomfort.

[0007] CN115487258A discloses a traditional Chinese medicine composition for treating gastroesophageal reflux disease, comprising the following components in parts by weight: Bupleurum chinense 6-10 parts, Cyperus rotundus 8-10 parts, Citrus aurantium 8-10 parts, Pinellia ternata 6-9 parts, Gardenia jasminoides 6-10 parts, Coptis chinensis 4-6 parts, Evodia rutaecarpa 3 parts, Hedyotis diffusa 15 parts, Ostrea gigas 20-30 parts, Perilla frutescens 10 parts, Hematite 15 parts, Cuttlebone 20-30 parts, Paeonia lactiflora 15 parts, Poria cocos 20 parts, Inula japonica 10 parts, and Glycyrrhiza uralensis 6 parts. This traditional Chinese medicine composition contains strong sedative and rebellious herbs (Ostrea gigas, Hematite, and Cuttlebone), which have a strong descending effect, thus counteracting the ascending and invigorating effect of liver qi, resulting in insufficient qi regulation. Poria cocos alone promotes diuresis and eliminates dampness, lacking tonifying power, and its phlegm-resolving and digestion-aiding effects are weak.

[0008] CN104306941A discloses a drug for non-erosive gastroesophageal reflux disease, made from the following raw materials in parts by weight: Bupleurum chinense 10-14 parts, Citrus aurantium 10-14 parts, Coptis chinensis 2-4 parts, Evodia rutaecarpa 2-4 parts, Gynostemma pentaphyllum 10-14 parts, Hematite 13-17 parts, Gardenia jasminoides 4-8 parts, Corydalis yanhusuo 10-14 parts, Melia toosendan 7-11 parts, Calcined oyster shell 27-33 parts, fresh ginger 2-4 parts, and Glycyrrhiza uralensis 4-8 parts. This formula contains no spleen-strengthening herbs, focusing solely on purging without tonifying, only regulating qi and relieving pain to treat the symptoms. Prolonged use depletes qi and easily leads to relapse. Gynostemma pentaphyllum only clears the lungs and resolves phlegm, offering limited improvement for patients with internal phlegm-heat in the middle jiao and upward reversal of stomach qi with phlegm. Summary of the Invention

[0009] In view of the above, one object of the present invention is to provide a traditional Chinese medicine composition for treating gastroesophageal reflux disease (GERD). This traditional Chinese medicine composition can be used to treat GERD, especially non-erosive GERD. It can address the root cause by soothing the liver and stomach, and relieving nausea and vomiting. Furthermore, the traditional Chinese medicine composition of the present invention can improve the patient's mood and regulate emotions. Even further, the traditional Chinese medicine composition of the present invention has a low recurrence rate. Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition as described above. A further object of the present invention is to provide a pharmaceutical preparation for treating GERD. This pharmaceutical preparation facilitates drug absorption. Furthermore, this pharmaceutical preparation is easy for patients to take, improving patient compliance. Yet another object of the present invention is to provide a method for preparing the pharmaceutical preparation as described above. A further object of the present invention is to provide the use of the traditional Chinese medicine composition or pharmaceutical preparation as described above.

[0010] The present invention achieves the above objectives using the following technical solutions.

[0011] On one hand, the present invention provides a traditional Chinese medicine composition for treating gastroesophageal reflux disease, the traditional Chinese medicine composition being made from the following raw materials: Bupleurum chinense 3-10 parts by weight, Paeonia lactiflora 3-10 parts by weight, Cyperus rotundus 3-10 parts by weight, Angelica dahurica 3-10 parts by weight, Acorus tatarinowii 3-10 parts by weight, Taraxacum mongolicum 3-10 parts by weight, Coptis chinensis 1-5 parts by weight, Evodia rutaecarpa 1-4 parts by weight, Fritillaria thunbergii 4-12 parts by weight, Pinellia ternata 3-10 parts by weight, Bambusa textilis 4-12 parts by weight, Medicated leaven 4-12 parts by weight, Atractylodes macrocephala 3-10 parts by weight, Citrus aurantium 3-10 parts by weight, and Glycyrrhiza uralensis 1-5 parts by weight.

[0012] According to the traditional Chinese medicine composition of the present invention, preferably, the traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 5-8 parts by weight, Paeonia lactiflora 5-9 parts by weight, Cyperus rotundus 5-9 parts by weight, Angelica dahurica 5-9 parts by weight, Acorus tatarinowii 5-9 parts by weight, Taraxacum mongolicum 5-9 parts by weight, Coptis chinensis 2-4 parts by weight, Evodia rutaecarpa 1-3 parts by weight, Fritillaria thunbergii 6-10 parts by weight, Pinellia ternata 5-9 parts by weight, Bambusa textilis 5-10 parts by weight, Medicated leaven 5-10 parts by weight, Atractylodes macrocephala 5-9 parts by weight, Citrus aurantium 5-9 parts by weight, and Glycyrrhiza uralensis 2-4 parts by weight.

[0013] According to the traditional Chinese medicine composition of the present invention, preferably, the traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 3-10 parts by weight, Paeonia lactiflora 3-10 parts by weight, Cyperus rotundus 3-10 parts by weight, Angelica dahurica 3-10 parts by weight, Acorus tatarinowii 3-10 parts by weight, Taraxacum mongolicum 3-10 parts by weight, Coptis chinensis 1-5 parts by weight, Evodia rutaecarpa 1-4 parts by weight, Fritillaria thunbergii 4-12 parts by weight, Pinellia ternata 3-10 parts by weight, Bambusa textilis 4-12 parts by weight, Medicated leaven 4-12 parts by weight, Atractylodes macrocephala 3-10 parts by weight, Citrus aurantium 3-10 parts by weight, and Glycyrrhiza uralensis 1-5 parts by weight.

[0014] According to the traditional Chinese medicine composition of the present invention, preferably, the traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 6 parts by weight, Paeonia lactiflora 6 parts by weight, Cyperus rotundus 6 parts by weight, Angelica dahurica 6 parts by weight, Acorus tatarinowii 6 parts by weight, Taraxacum mongolicum 6 parts by weight, Coptis chinensis 3 parts by weight, Evodia rutaecarpa 2 parts by weight, Fritillaria thunbergii 8 parts by weight, Pinellia ternata 6 parts by weight, Bambusa textilis 8 parts by weight, Medicated leaven 8 parts by weight, Atractylodes macrocephala 6 parts by weight, Citrus aurantium 6 parts by weight, and Glycyrrhiza uralensis 3 parts by weight; wherein, the Atractylodes macrocephala is stir-fried; the Citrus aurantium is stir-fried; and the Glycyrrhiza uralensis is prepared by roasting.

[0015] On the other hand, the present invention provides a method for preparing the traditional Chinese medicine composition as described above, preferably comprising the following steps: using water as the extraction solvent for each raw material medicine, extracting it by decoction, heating and reflux extraction or ultrasonic extraction, concentrating and mixing the extract to obtain the traditional Chinese medicine composition; or mixing and concentrating the extract to obtain the traditional Chinese medicine composition.

[0016] In another aspect, the present invention provides a pharmaceutical preparation for treating gastroesophageal reflux disease, comprising the traditional Chinese medicine composition as described above and pharmaceutically acceptable excipients.

[0017] According to the pharmaceutical preparation of the present invention, preferably, the pharmaceutical preparation is an oral preparation.

[0018] In another aspect, the present invention provides a method for preparing a pharmaceutical preparation for treating gastroesophageal reflux disease as described above, comprising the following steps: using water as the extraction solvent, extracting each raw material in the traditional Chinese medicine composition as described above by decoction, reflux extraction or ultrasonic extraction, concentrating the extract to obtain a clear extract of each component; adding excipients to the clear extract of each component, granulating them to obtain component granules; mixing the component granules to obtain a pharmaceutical preparation (referred to as traditional Chinese medicine granules).

[0019] In another aspect, the present invention provides the use of the traditional Chinese medicine composition or pharmaceutical preparation described above in the preparation of a medicament for treating gastroesophageal reflux disease.

[0020] According to the intended use of the present invention, preferably, the gastroesophageal reflux disease is non-erosive reflux disease, and the TCM diagnosis is liver-stomach disharmony syndrome.

[0021] The traditional Chinese medicine composition of this invention can be used to treat gastroesophageal reflux disease, especially non-erosive reflux disease. This composition regulates liver, spleen, and stomach functions by soothing the liver and regulating qi, harmonizing the stomach and suppressing rebellious qi. It not only relieves symptoms but also improves patients' anxiety and depression, breaking the vicious cycle of "emotional fluctuations - liver qi invading the stomach - symptom recurrence," resulting in a low recurrence rate (less than 17%). Detailed Implementation

[0022] The present invention will be further described below with reference to specific embodiments, but the scope of protection of the present invention is not limited thereto.

[0023] Based on pharmaceutical research and years of clinical experience, the inventors believe that the core pathogenesis of NERD is disharmony between the liver and stomach, and upward reversal of stomach qi. The inventors believe that although the pathogenesis of NERD is located in the esophagus and stomach, it is closely related to dysfunction of the liver's dispersing and regulating function and imbalance of the spleen and stomach's ascending and descending functions. Modern people face significant work and life pressures, and emotional distress easily leads to liver qi stagnation, which over time generates heat. Coupled with irregular eating habits and overeating, this easily damages the spleen and stomach function, resulting in weak spleen and stomach function, imbalance of qi in the middle jiao, and upward reversal of stomach qi carrying acid, thus causing a series of symptoms such as acid reflux, heartburn, and belching. Based on this core pathogenesis, the inventors established "soothing the liver and harmonizing the stomach" as the core therapeutic principle of the drug composition of this invention, precisely selecting and formulating the drug, achieving satisfactory clinical results. The drug composition of this invention is not a conventional choice. A detailed description follows.

[0024] <Traditional Chinese Medicine Composition> This invention provides a traditional Chinese medicine composition for treating gastroesophageal reflux disease, made from the following raw materials: Bupleurum chinense 3-10 parts by weight, Paeonia lactiflora 3-10 parts by weight, Cyperus rotundus 3-10 parts by weight, Angelica dahurica 3-10 parts by weight, Acorus tatarinowii 3-10 parts by weight, Taraxacum mongolicum 3-10 parts by weight, Coptis chinensis 1-5 parts by weight, Evodia rutaecarpa 1-4 parts by weight, Fritillaria thunbergii 4-12 parts by weight, Pinellia ternata 3-10 parts by weight, Bambusa textilis 4-12 parts by weight, Medicated leaven 4-12 parts by weight, Atractylodes macrocephala 3-10 parts by weight, Citrus aurantium 3-10 parts by weight, and Glycyrrhiza uralensis 1-5 parts by weight.

[0025] Preferably, the traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 5-8 parts by weight, Paeonia lactiflora 5-9 parts by weight, Cyperus rotundus 5-9 parts by weight, Angelica dahurica 5-9 parts by weight, Acorus tatarinowii 5-9 parts by weight, Taraxacum mongolicum 5-9 parts by weight, Coptis chinensis 2-4 parts by weight, Evodia rutaecarpa 1-3 parts by weight, Fritillaria thunbergii 6-10 parts by weight, Pinellia ternata 5-9 parts by weight, Bambusa textilis 5-10 parts by weight, Medicated leaven 5-10 parts by weight, Atractylodes macrocephala 5-9 parts by weight, Citrus aurantium 5-9 parts by weight, and Glycyrrhiza uralensis 2-4 parts by weight.

[0026] More preferably, the traditional Chinese medicine composition is made solely from the following raw materials: Bupleurum chinense 3-10 parts by weight, Paeonia lactiflora 3-10 parts by weight, Cyperus rotundus 3-10 parts by weight, Angelica dahurica 3-10 parts by weight, Acorus tatarinowii 3-10 parts by weight, Taraxacum mongolicum 3-10 parts by weight, Coptis chinensis 1-5 parts by weight, Evodia rutaecarpa 1-4 parts by weight, Fritillaria thunbergii 4-12 parts by weight, Pinellia ternata 3-10 parts by weight, Bambusa textilis 4-12 parts by weight, Medicated leaven 4-12 parts by weight, Atractylodes macrocephala 3-10 parts by weight, Citrus aurantium 3-10 parts by weight, and Glycyrrhiza uralensis 1-5 parts by weight.

[0027] More preferably, the traditional Chinese medicine composition is made solely from the following raw materials: Bupleurum chinense 5-8 parts by weight, Paeonia lactiflora 5-9 parts by weight, Cyperus rotundus 5-9 parts by weight, Angelica dahurica 5-9 parts by weight, Acorus tatarinowii 5-9 parts by weight, Taraxacum mongolicum 5-9 parts by weight, Coptis chinensis 2-4 parts by weight, Evodia rutaecarpa 1-3 parts by weight, Fritillaria thunbergii 6-10 parts by weight, Pinellia ternata 5-9 parts by weight, Bambusa textilis 5-10 parts by weight, Medicated leaven 5-10 parts by weight, Atractylodes macrocephala 5-9 parts by weight, Citrus aurantium 5-9 parts by weight, and Glycyrrhiza uralensis 2-4 parts by weight.

[0028] According to one embodiment of the present invention, the traditional Chinese medicine composition is made solely from the following raw materials: Bupleurum chinense 6 parts by weight, Paeonia lactiflora 6 parts by weight, Cyperus rotundus 6 parts by weight, Angelica dahurica 6 parts by weight, Acorus tatarinowii 6 parts by weight, Taraxacum mongolicum 6 parts by weight, Coptis chinensis 3 parts by weight, Evodia rutaecarpa 2 parts by weight, Fritillaria thunbergii 8 parts by weight, Pinellia ternata 6 parts by weight, Bambusa textilis 8 parts by weight, Medicated leaven 8 parts by weight, Atractylodes macrocephala 6 parts by weight, Citrus aurantium 6 parts by weight, and Glycyrrhiza uralensis 3 parts by weight.

[0029] In this invention, Atractylodes macrocephala is preferably stir-fried. Citrus aurantium is preferably stir-fried. Glycyrrhiza uralensis is preferably processed.

[0030] The components of the traditional Chinese medicine composition of the present invention work together to soothe the liver and stomach, relieve nausea and vomiting, promote the smooth flow of liver qi and the downward flow of stomach qi, thereby fundamentally improving liver-stomach disharmony and upward flow of stomach qi, effectively relieving liver qi stagnation and preventing recurrence.

[0031] In the pharmaceutical composition of this invention, Bupleurum is the principal ingredient. It is bitter and slightly cold in nature, and it soothes the liver, relieves stagnation, and raises Yang Qi. On the one hand, it inhibits gastric acid secretion and regulates gastrointestinal function; on the other hand, it harmonizes Qi, thus alleviating liver Qi stagnation at its root.

[0032] Cyperus rotundus, Pinellia ternata, bamboo shavings, Citrus aurantium, Coptis chinensis, Evodia rutaecarpa, Atractylodes macrocephala, and Acorus tatarinowii are the assistant herbs. Cyperus rotundus is slightly sweet and neutral in nature, soothing the liver, relieving depression, regulating qi, and relieving pain. It can assist Bupleurum chinense in soothing the liver and regulating qi, and also improve the patient's mood. Pinellia ternata is warm in nature, and relieves nausea and vomiting. Bamboo shavings are slightly cold in nature, clearing heat and resolving phlegm, relieving irritability and stopping vomiting, especially suitable for vomiting caused by stomach heat. The combination of Pinellia ternata and bamboo shavings can enhance the effect of harmonizing the stomach and relieving nausea. Citrus aurantium (especially stir-fried Citrus aurantium) breaks up qi stagnation and eliminates food stagnation, mainly treating chest tightness, hypochondriac distension, food stagnation, belching, and vomiting, assisting the principal herb Bupleurum chinense in regulating qi, relieving chest tightness, and relieving stomach qi stagnation. Coptis chinensis and Evodia rutaecarpa are combined to clear liver fire, warm the stomach, and relieve nausea, and can treat liver and stomach heat stagnation, acid reflux, and heartburn. Atractylodes macrocephala (especially stir-fried Atractylodes macrocephala) strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, promotes gastrointestinal motility, and enhances intestinal barrier function. Acorus tatarinowii has aromatic properties that dispel dampness, invigorate the spleen, and harmonize the stomach. All of the above herbs work together as assistant herbs, assisting the principal herb in enhancing its effects of soothing the liver and suppressing adverse reactions.

[0033] White peony root, dandelion, angelica root, fritillaria bulb, and medicated leaven are used as adjuvant herbs, providing supplementary effects of clearing heat, resolving turbidity, promoting digestion, and strengthening the spleen. White peony root is slightly cold in nature, nourishing blood, softening the liver, and relieving pain. Dandelion is bitter and cold in nature, clearing heat, detoxifying, and dispersing nodules. Angelica root is warm in nature, aromatically resolving turbidity, invigorating the spleen, and relieving pain. Fritillaria bulb is bitter and cold in nature, clearing heat, resolving phlegm, and dispersing nodules. Medicated leaven is bitter and warm in nature, promoting digestion, harmonizing the stomach, regulating qi, and resolving dampness.

[0034] Licorice (especially roasted licorice) is used as an adjuvant to harmonize the effects of other herbs and to replenish qi and strengthen the spleen.

[0035] The herbal composition of this invention combines cold and warm properties, regulates ascending and descending functions, and integrates tonification and purgation, making it highly applicable to gastroesophageal reflux disease (GERD) with liver-stomach disharmony, especially non-erosive GERD. Compared with existing technologies, this invention does not contain heavy sedative mineral drugs such as hematite, calcined oyster shell, and mother-of-pearl, avoiding stomach damage from prolonged use; at the same time, it is combined with sedative and calming herbs such as Cyperus rotundus and Acorus tatarinowii, which can improve patients' anxiety and depression, thereby breaking the vicious cycle of emotional fluctuations-liver qi invading the stomach-symptom recurrence and significantly reducing the recurrence rate.

[0036] <Preparation Method of Traditional Chinese Medicine Composition> The traditional Chinese medicine composition of the present invention can be obtained by extraction and preparation using conventional methods in the art. Any method capable of fully extracting the effective chemical components from the traditional Chinese medicine composition of the present invention can be applied. According to a preferred preparation method of the present invention, the step of extracting all medicinal materials with water is included. The present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: extracting each raw material with water as the extraction solvent using decoction, reflux extraction, or ultrasonic extraction; concentrating the extract to obtain the traditional Chinese medicine composition. According to one embodiment of the present invention, the method for preparing the traditional Chinese medicine composition comprises the following steps: taking all medicinal materials, decocting them with water 1 to 4 times, adding 6 to 20 times the weight of the medicinal materials each time, and extracting for 0.3 to 3.5 hours each time; concentrating the extract to obtain the traditional Chinese medicine composition. More preferably, decocting with water 1 to 3 times, adding 8 to 15 times the weight of the medicinal materials each time, and extracting for 0.5 to 3 hours each time.

[0037] In the preparation steps of the above-mentioned traditional Chinese medicine composition, decoction is preferably carried out over medium heat.

[0038] <Pharmaceutical Preparations and Their Preparation Methods> The present invention also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition as described above and pharmaceutically acceptable excipients.

[0039] In this invention, pharmaceutically acceptable excipients refer to pharmaceutical excipients conventional in the field of pharmaceutical formulations, which may be selected from one or more of fillers, binders, disintegrants, lubricants, pigments, flavoring agents, solvents, and stabilizers.

[0040] In this invention, fillers include, but are not limited to, starch, microcrystalline cellulose, sucrose, dextrin, lactose, mannitol, sorbitol, etc.; binders include, but are not limited to, starch paste, syrup, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, sodium alginate, povidone, methylcellulose, gum arabic, etc.; disintegrants include, but are not limited to, starch effervescent mixtures (i.e., sodium bicarbonate and citric acid), tartaric acid, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include, but are not limited to, magnesium stearate, stearic acid, sodium oleate, polyethylene glycol, micronized silica, talc, etc.; pigments include, but are not limited to, iron oxide, sodium copper chlorophyllin, β-carotene, tartrazine, indigo, etc.; flavoring agents include, but are not limited to, sucrose, fructose, sorbitol, mannitol, aspartame, sodium saccharin, fruit flavoring, peppermint flavoring, etc.; solvents include, but are not limited to, water, ethanol, etc.; stabilizers include, but are not limited to, silica, magnesium stearate, etc.

[0041] According to one specific embodiment of the present invention, the pharmaceutical preparation of the present invention uses the traditional Chinese medicine composition as the pharmaceutically active ingredient, but does not include other active ingredients. The pharmaceutical preparation is an oral preparation.

[0042] The oral formulations of the present invention can be oral solid dosage forms, such as dispersible tablets, enteric-coated tablets, granules, capsules, pills, powders, etc.; or oral liquid dosage forms, including but not limited to drug solutions, suspensions, and emulsions. Capsules or granules are preferred; granules are more preferred. According to a specific embodiment of the present invention, the pharmaceutical formulation of the present invention is a traditional Chinese medicine granule made from the traditional Chinese medicine composition described above.

[0043] Each bag of pharmaceutical preparation (traditional Chinese medicine granules) contains 60 to 100 parts by weight of prepared traditional Chinese medicine pieces; preferably, the total weight of prepared traditional Chinese medicine pieces is 75 to 90 parts by weight; more preferably, the total weight of prepared traditional Chinese medicine pieces is 83 to 88 parts by weight. According to one embodiment of the present invention, one bag of traditional Chinese medicine granules contains 86 parts by weight of prepared traditional Chinese medicine pieces.

[0044] This invention also provides a method for preparing a pharmaceutical preparation. The pharmaceutical preparation of this invention can be prepared using conventional formulation methods in the art. According to a preferred preparation method of this invention, the method includes the steps of extracting all medicinal materials separately with water, preparing all medicinal materials into component granules separately, and mixing all component granules. This invention provides a method for preparing a pharmaceutical preparation, comprising the following steps: extracting each raw material in the above-mentioned traditional Chinese medicine composition using water as the extraction solvent, employing decoction, reflux extraction, or ultrasonic extraction; concentrating the extracts separately to obtain clear extracts of each component; adding excipients to the clear extracts of each component separately, granulating them separately to obtain component granules, mixing them, and obtaining the pharmaceutical preparation. According to one embodiment of this invention, the method for preparing the pharmaceutical preparation comprises the following steps: taking all medicinal materials, decocting them separately with water 1 to 4 times, adding 6 to 20 times the weight of the medicinal materials with water each time, extracting for 0.3 to 3.5 hours each time, concentrating the extracts, then adding pharmaceutically acceptable excipients, drying, preparing formulation granules corresponding to each raw material, mixing them, and obtaining the pharmaceutical preparation. More preferably, the herbs are decocted in water 1 to 3 times, with 8 to 15 times the weight of the herbs added each time, and the extraction time is 0.5 to 3 hours each time.

[0045] In the preparation steps of the above-mentioned pharmaceutical preparation, decoction is preferably performed over medium heat. Pharmaceutically acceptable excipients are preferably one or more of maltodextrin or lactose.

[0046] <Uses of Traditional Chinese Medicine Compositions> The present invention also provides the use of the traditional Chinese medicine composition described above in the preparation of a medicament for treating gastroesophageal reflux disease.

[0047] In this invention, the gastroesophageal reflux disease is preferably non-erosive reflux disease. Using the traditional Chinese medicine granules of this invention to prepare a drug for treating non-erosive reflux disease, experiments showed that its effectiveness rate is greater than or equal to 80%. Preferably, the effectiveness rate is greater than or equal to 83%. More preferably, the effectiveness rate is greater than 83.3%. Its recurrence rate is less than 17%. Preferably, it is less than 16.5%.

[0048] In this invention, the traditional Chinese medicine composition for treating gastroesophageal reflux disease (GERD) falls under the TCM syndrome of liver-stomach disharmony. Preferably, the TCM composition of this invention treats GERD according to the TCM syndrome of liver-stomach disharmony, and its effect is particularly significant for patients with concurrent indigestion and qi stagnation. The TCM composition of this invention is significantly effective in treating GERD and has a low recurrence rate. Experiments using the TCM granules of this invention to treat liver-stomach disharmony showed an efficacy rate of ≥65%. Preferably, the efficacy rate is ≥78%. More preferably, the efficacy rate is ≥80%.

[0049] Example 1 - Traditional Chinese Medicine Composition The traditional Chinese medicine composition in this embodiment is prepared from the following raw materials according to the national standard for the preparation of formula granules. The specific preparation method is as follows: Add 6 parts by weight of Bupleurum to 10 times the amount of water, decoct over medium heat for 1 hour, and separate to obtain the first decoction and the first residue; add 8 times the amount of water to the first residue, decoct over medium heat for 1 hour, and separate to obtain the second decoction and the second residue; combine the first and second decoctions and concentrate to obtain Bupleurum Extract. The dry extract yield of Bupleurum Extract is 15%.

[0050] Add 6 parts by weight of white peony root to 12 times the amount of water, decoct over medium heat for 1 hour, and separate to obtain the first decoction and the first residue; add 10 times the amount of water to the first residue, decoct over medium heat for 1 hour, and separate to obtain the second decoction and the second residue; combine the first and second decoctions and concentrate to obtain white peony root extract. The dry extract yield of white peony root extract is 18%.

[0051] Six parts by weight of Cyperus rotundus were added to 10 times the amount of water and simmered over medium heat for 1 hour. The decoction was then separated. The decoction was concentrated to obtain Cyperus rotundus extract. The dry extract yield of Cyperus rotundus extract was 18%.

[0052] Add 6 parts by weight of Acorus tatarinowii to 8 times the amount of water, decoct over medium heat for 2 hours, and separate to obtain the first decoction and the first dregs; add 10 times the amount of water to the first dregs, decoct over medium heat for 1 hour, and separate to obtain the second decoction and the second dregs; combine the first and second decoctions and concentrate to obtain Acorus tatarinowii extract. The dry extract yield of Acorus tatarinowii extract is 10%.

[0053] Add 6 parts by weight of Angelica dahurica to 10 times the amount of water, decoct over medium heat for 1 hour, and separate to obtain the first decoction and the first residue; add 10 times the amount of water to the first residue, decoct over medium heat for 1 hour, and separate to obtain the second decoction and the second residue; combine the first and second decoctions and concentrate to obtain Angelica dahurica extract. The dry extract yield of Angelica dahurica extract is 26%.

[0054] Add 6 parts by weight of dandelion to 10 times the amount of water, decoct over medium heat for 1.5 hours, and separate to obtain the first decoction and the first residue; add 8 times the amount of water to the first residue, decoct over medium heat for 0.5 hours, and separate to obtain the second decoction and the second residue; combine the first and second decoctions and concentrate to obtain dandelion extract. The dry extract yield of dandelion extract is 22%.

[0055] Add 3 parts by weight of Coptis chinensis to 10 times the amount of water, decoct over medium heat for 1.5 hours, and separate to obtain the first decoction and the first residue; add 10 times the amount of water to the first residue, decoct over medium heat for 0.5 hours, and separate to obtain the second decoction and the second residue; combine the first and second decoctions and concentrate to obtain Coptis chinensis extract. The dry extract yield of Coptis chinensis extract is 18%.

[0056] Two parts by weight of Evodia rutaecarpa were added to 10 times the amount of water and decocted over medium heat for 1 hour. The first decoction and the first dregs were then separated. Eight times the amount of water was added to the first dregs and decocted over medium heat for 1 hour. The second decoction and the second dregs were then separated. The first and second decoctions were combined and concentrated to obtain Evodia rutaecarpa extract. The dry extract yield of Evodia rutaecarpa extract was 28%.

[0057] Eight parts by weight of Fritillaria thunbergii were added to 10 times the amount of water and simmered over medium heat for 1 hour. The first decoction and the first residue were then separated. Ten times the amount of water were added to the first residue and simmered over medium heat for 1 hour. The second decoction and the second residue were then separated. The first and second decoctions were combined and concentrated to obtain Fritillaria thunbergii extract. The dry extract yield of Fritillaria thunbergii extract was 19%.

[0058] Six parts by weight of processed Pinellia ternata were added to 10 times the amount of water and decocted over medium heat for 1 hour. The first decoction and the first dregs were then separated. Eight times the amount of water was added to the first dregs and decocted over medium heat for 1 hour. The second decoction and the second dregs were then separated. The first and second decoctions were combined and concentrated to obtain processed Pinellia ternata extract. The dry extract yield of processed Pinellia ternata extract was 19%.

[0059] Eight parts by weight of bamboo shavings were added to ten times the amount of water and simmered over medium heat for 1 hour. The first decoction and the first residue were then separated. Ten times the amount of water were added to the first residue and simmered over medium heat for 1 hour. The second decoction and the second residue were then separated. The first and second decoctions were combined and concentrated to obtain bamboo shaving extract. The dry extract yield of bamboo shaving extract was 8%.

[0060] Eight parts by weight of Jianqu were added to ten times the amount of water and simmered over medium heat for 1 hour. The first decoction and the first residue were then separated. Eight times the amount of water were added to the first residue and simmered over medium heat for 0.5 hours. The second decoction and the second residue were then separated. The first and second decoctions were combined and concentrated to obtain Jianqu Qinggao (clear extract). The dry extract yield of Jianqu Qinggao was 16%.

[0061] Add 6 parts by weight of stir-fried Atractylodes macrocephala to 10 times the amount of water and simmer over medium heat for 1.5 hours. Separate the first decoction and the first residue. Add 12 times the amount of water to the first residue and simmer over medium heat for 0.5 hours. Separate the second decoction and the second residue. Combine the first and second decoctions and concentrate them to obtain stir-fried Atractylodes macrocephala extract. The dry extract yield of the stir-fried Atractylodes macrocephala extract is 50%.

[0062] Add 6 parts by weight of stir-fried Citrus aurantium to 12 times the amount of water, decoct over medium heat for 2 hours, and separate to obtain the first decoction and the first dregs; add 10 times the amount of water to the first dregs, decoct over medium heat for 1 hour, and separate to obtain the second decoction and the second dregs; combine the first and second decoctions and concentrate to obtain the stir-fried Citrus aurantium extract. The dry extract yield of the stir-fried Citrus aurantium extract is 27%.

[0063] Add 3 parts by weight of prepared licorice root to 15 times the amount of water, decoct over medium heat for 1.5 hours, and separate to obtain the first decoction and the first residue; add 8 times the amount of water to the first residue, decoct over medium heat for 0.5 hours, and separate to obtain the second decoction and the second residue; combine the first and second decoctions and concentrate to obtain prepared licorice root extract. The dry extract yield of prepared licorice root extract is 38%.

[0064] The obtained extracts can be mixed to form a traditional Chinese medicine composition. Alternatively, the extracts can be prepared separately for use in the next step of developing a traditional Chinese medicine preparation.

[0065] Example 2 - Pharmaceutical Formulation Maltodextrin was added to the following extracts prepared in Example 1: Bupleurum extract, White peony extract, Cyperus extract, Acorus extract, Angelica dahurica extract, Dandelion extract, Coptis extract, Evodia extract, Fritillaria thunbergii extract, Bamboo shavings extract, Medicated leaven extract, Atractylodes macrocephala extract, and Citrus aurantium extract. The extracts were then dried and pulverized into fine powders. Maltodextrin and lactose were added to the following extracts prepared in Example 1: Prepared licorice extract and Prepared Pinellia ternata extract. The extracts were then dried and pulverized into fine powders. Maltodextrin was then added to each of these fine powders, mixed thoroughly, and granulated to obtain the corresponding component granules.

[0066] The obtained component granules are mixed and packaged into bags according to a specific weight ratio to obtain a pharmaceutical preparation (denoted as traditional Chinese medicine granules), with a specification of 25.27g / bag. The specific weight ratios are as follows: Bupleurum component granules, White peony component granules, Cyperus component granules, Acorus component granules, Angelica dahurica component granules, Dandelion component granules, Coptis component granules, Evodia component granules, Fritillaria thunbergii component granules, Pinellia ternata component granules, Bambusa textilis component granules, Medicated leaven component granules, Fried Atractylodes macrocephala component granules, Fried Citrus aurantium component granules, and Prepared licorice component granules are 1.5 parts by weight, 1.33 parts by weight, 1.2 parts by weight, 1.28 parts by weight, 2 parts by weight, 1.62 parts by weight, 0.67 parts by weight, 0.61 parts by weight, 2 parts by weight, 1.76 parts by weight, 0.8 parts by weight, 2 parts by weight, 5 parts by weight, 2 parts by weight, and 1.5 parts by weight.

[0067] Experimental Example 1 1. Clinical Data 1.1 Research Subjects This study included 60 patients who met the inclusion criteria. All of them were patients who visited the Department of Gastroenterology at the two campuses of Dongzhimen Hospital of Beijing University of Chinese Medicine between March 2025 and January 2026.

[0068] 1.2 Grouping This study employed a randomized controlled clinical trial method. Random numbers were generated and random assignments were produced using SAS 9.2 software. Patients were randomly divided into two groups at a 1:1 ratio: a treatment group and a control group, with 30 patients in each group. There were no significant differences in gender, age, or disease duration between the two groups.

[0069] 1.3 Diagnostic criteria 1.3.1 Western Medicine Diagnostic Criteria The diagnostic criteria for non-erosive reflux disease (NERD) were developed with reference to the "2020 Chinese Expert Consensus on Gastroesophageal Reflux Disease".

[0070] Clinical symptoms: Typical symptoms include heartburn and regurgitation; atypical symptoms include chest pain, upper abdominal burning sensation, upper abdominal distension, upper abdominal pain and belching, etc., after ruling out cardiac diseases; Endoscopic examination: Endoscopic examinations in the past 6 months have been negative, and no obvious roughness or damage to the esophageal mucosa was found.

[0071] 1.3.2 Traditional Chinese Medicine Diagnostic Criteria Refer to the relevant diagnostic criteria for liver-stomach disharmony syndrome in the "Consensus Opinion on the Diagnosis and Treatment of Gastroesophageal Reflux Disease with Integrated Traditional Chinese and Western Medicine (2017)".

[0072] Main symptoms: (1) acid reflux; (2) retrosternal pain; (3) chest and rib distension; Secondary symptoms: (1) chest tightness and frequent sighing; (2) emotional distress; (3) nausea and vomiting; Tongue and pulse: The tongue is pale red with a white or thin white coating, and the pulse is wiry.

[0073] If two primary symptoms and two secondary symptoms are present, and the tongue and pulse are examined, a diagnosis of liver-stomach disharmony can be made.

[0074] 1.4 Inclusion Criteria (1) Age 18-75 years old, gender not limited; (2) Simultaneously meets the above-mentioned Western medicine diagnostic criteria and traditional Chinese medicine syndrome diagnosis criteria; (3) Sign the informed consent form.

[0075] 1.5 Exclusion Criteria (1) History of surgery on the stomach, esophagus and duodenum; (2) Use of proton pump inhibitors (PPIs) or H2 receptor blockers within 2 weeks prior to enrollment; (3) Suffering from Zollinger-Ellison syndrome or primary esophageal motility disorder; (4) Patients with serious primary diseases of the liver, kidneys, hematopoietic system, heart, lungs, endocrine system, etc., and malignant tumors; (5) Pregnant women or women who are planning to become pregnant, and breastfeeding women; (6) Allergic constitution, such as a history of allergy to two or more drugs or foods; (7) Patients with severe mental illness; (8) Participate in other clinical trials within 1 month.

[0076] 1.6 Rejection Criteria (1) Patients for whom there is insufficient data to conduct efficacy and safety assessments; (2) Those who fail to use the medication as prescribed, change the test drug, or use prohibited drugs during the trial period.

[0077] 1.7 Shedding Criteria (1) The patient withdrew voluntarily; (2) Loss to follow-up.

[0078] 2. Treatment Plan Control group: Rabeprazole sodium enteric-coated tablets (20mg × 30 tablets / box, National Drug Approval Number H20020330) were administered orally, one tablet (20mg per tablet) once daily, half an hour before meals, for 4 consecutive weeks. Follow-up was conducted 4 weeks after discontinuation of the medication.

[0079] Treatment group: Oral administration of the traditional Chinese medicine granules of Example 2, one sachet each time, twice a day, half an hour after meals (the traditional Chinese medicine granules were processed by Beijing Kangrentang Pharmaceutical Co., Ltd.), for 4 consecutive weeks. Follow-up was conducted 4 weeks after discontinuation of medication.

[0080] In addition to the investigational drug, other medications for treating NERD are prohibited during the observation period.

[0081] 3. Observation Indicators The following indicators were compared and recorded between the two groups of patients before treatment, after treatment (i.e., after 4 weeks of treatment), and during the follow-up period (4 weeks after discontinuation of medication).

[0082] 3.1 Reflux Disease Questionnaire (RDQ) The RDQ scale was compared between the treatment group before and after treatment, and between the control group and the treatment group after treatment and during the follow-up period to evaluate the clinical efficacy of the treatment regimen for NERD patients.

[0083] 3.2 7-point Likert scale Patient satisfaction with symptom improvement was assessed using a 7-point Likert scale (1 = very dissatisfied, 7 = very satisfied). Differences in scores between the control and treatment groups were compared after treatment and during the follow-up period.

[0084] 3.3 Traditional Chinese Medicine Clinical Symptom Scores The clinical efficacy of the treatment regimen for patients with liver-stomach disharmony syndrome was evaluated by comparing the TCM clinical symptom scores of the treatment group before and after treatment, and the scores of the control group and the treatment group after treatment.

[0085] 3.4 Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) The GERD-HRQL scale was compared between the treatment group before and after treatment, and between the control group and the treatment group after treatment to evaluate the effect of the treatment regimen on improving the quality of life of patients with liver-stomach disharmony syndrome.

[0086] 3.5 Criteria for Recurrence Relapse: (1) RDQ score <12 after treatment (at the time of drug discontinuation), clinical symptoms worsened and RDQ score ≥12 during the follow-up period; (2) RDQ score ≥12 after treatment (at the time of drug discontinuation), RDQ score increased by ≥50% during the follow-up period compared with after treatment.

[0087] No recurrence: (1) No worsening of clinical symptoms during the follow-up period compared to after treatment (when medication was discontinued); (2) RDQ score <12 during the follow-up period; (3) RDQ score <50% increase during the follow-up period compared to after treatment (when medication was discontinued).

[0088] Relapse rate (%) = Number of patients with relapse / Total number of effective cases in the group that completed the trial × 100%.

[0089] 4. Clinical effectiveness determination 4.1.1 Western Medicine Clinical Effectiveness Assessment By combining the RDQ scores and 7-point Likert scale scores of the two groups of patients, longitudinal and cross-sectional comparisons were made on the changes before treatment, after treatment, and during the follow-up period. The efficacy index (N%) and overall effective rate (M%) were calculated. The calculation formulas are as follows: Therapeutic efficacy index: N% = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%. Based on the obtained N% value, clinical effectiveness is divided into four levels: cured, significantly effective, effective, and ineffective. Specifically: (1) Cured: Symptoms and signs disappear or basically disappear, 95%≤N.

[0090] (2) Significant effect: Symptoms and signs are significantly improved, 70%≤N%<95%.

[0091] (3) Effective: Symptoms and signs improved, 30%≤N%<70%.

[0092] (4) Ineffective: Symptoms and signs do not improve significantly or worsen, N% < 30%.

[0093] Overall effective rate: M% = (number of cured cases + number of cases with significant improvement + number of effective cases) / total number of cases × 100%.

[0094] 4.2 TCM Clinical Effectiveness Assessment: Based on the patient's clinical symptoms, the main symptoms were scored according to severity, with scores of 0, 2, 4, and 6 points respectively; the secondary symptoms were scored according to severity, with scores of 0, 1, 2, and 3 points respectively. Referring to the "Consensus Opinion on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Gastroesophageal Reflux Disease (2017)," the TCM syndrome score efficacy index was calculated, using the same formula and assessment criteria as in 4.1.

[0095] 5. Statistical Methods Data analysis was performed using SPSS 26.0 statistical software. P A value ≤0.05 was considered statistically significant. Normality and homogeneity of variance tests were performed on each group of data. For normally distributed continuous data, a t-test was used. This indicates that nonparametric tests are used for continuous data that do not conform to a normal distribution. M ( P 25 , P 75 The comparison between two groups was performed using the Mann-Whitney U test, and the comparison within groups was performed using the Wilcoxon signed-rank test for related samples.

[0096] 6. Results The following comparisons between two groups were made using the RDQ scale, the 7-point Likert scale, the Traditional Chinese Medicine Clinical Symptom Score Scale, and the GERD-HRQL scale.U , P Statistical symbols, within-group comparisons use Z , P Statistical measurement symbols.

[0097] 6.1 Statistical Analysis of Clinical Data This study included 60 patients who met the inclusion criteria. All were diagnosed with non-erosive reflux disease (NERD) and, according to Traditional Chinese Medicine (TCM) diagnosis, had liver-stomach disharmony syndrome. There were 30 patients in the treatment group and 30 in the control group. There was no statistically significant difference in gender composition between the two groups. χ 2 / t = 2.052, P >0.05); there was no statistically significant difference in age between the two groups ( χ 2 / t = 0.442, P >0.05). The two groups of patients were comparable in terms of gender and age. See Table 1 for details. During the follow-up period, all ineffective cases dropped out in both the treatment and control groups; specifically, 5 cases dropped out in the treatment group and 6 cases dropped out in the control group. These dropped-out cases were not included in the final efficacy analysis (i.e., recurrence rate analysis).

[0098] Table 1

[0099] 6.2 RDQ Scale 6.2.1 The RDQ scale scores of the control group and the treatment group before treatment are shown in Table 2.

[0100] Table 2

[0101] Table 2 shows that the treatment group and the control group both had lower scores in total RDQ indicators, as well as indices related to acid reflux, heartburn, retrosternal pain, and regurgitation. P >0.05, indicating no statistically significant difference. This means the two groups of patients were comparable before treatment.

[0102] 6.2.2 The RDQ scale scores of the control group before and after treatment are shown in Table 3.

[0103] Table 3

[0104] As shown in Table 3, after treatment, the overall symptoms of NERD patients in the control group were significantly improved, especially the symptoms of acid reflux and heartburn.

[0105] 6.2.3 The RDQ scale scores of the treatment group before and after treatment are shown in Table 4.

[0106] Table 4

[0107] As shown in Table 4, the total RDQ score of NERD patients was significantly improved after treatment with the herbal granules of this invention. The herbal granules of this invention also significantly improve the symptoms of acid reflux, heartburn, and regurgitation exhibited by NERD patients.

[0108] 6.2.4 The RDQ scale scores of the control group and the treatment group after treatment are shown in Table 5.

[0109] Table 5

[0110] Table 5 shows that there was no statistically significant difference in the RDQ scale between the control group and the treatment group, but the total RDQ score of the treatment group was lower than that of the control group. The herbal granules of this invention have a slightly better therapeutic effect on NERD patients than rabeprazole sodium enteric-coated tablets.

[0111] 6.2.5 The RDQ scale scores of the control group after treatment and during the follow-up period are shown in Table 6.

[0112] Table 6

[0113] As shown in Table 6, the total RDQ score of the control group increased during the follow-up period, and the overall symptoms recurred, especially the symptoms of acid reflux and heartburn, which were significantly aggravated.

[0114] 6.2.6 The RDQ scale scores of the treatment group after treatment and during the follow-up period are shown in Table 7.

[0115] Table 7

[0116] As shown in Table 7, the acid reflux and heartburn symptom scores in the treatment group increased during the follow-up period compared to after treatment.

[0117] 6.2.7 The RDQ scale scores of the control group and the treatment group during the follow-up period are shown in Table 8.

[0118] Table 8

[0119] As shown in Table 8, the treatment group had significantly lower scores for acid reflux, heartburn, and total RDQ during the follow-up period compared to the control group. Compared to rabeprazole sodium enteric-coated tablets, the herbal granules of this invention exhibit potential disease-modifying properties, continuously improving the patient's condition after discontinuation of the medication without rebound effect.

[0120] According to the RDQ scale, in the control group, 24 patients showed overall effectiveness, 11 relapsed, and 13 remained healthy, with a relapse rate of 45.83%. In the treatment group, 25 patients showed overall effectiveness, 4 relapsed, and 21 remained healthy, with a relapse rate of 16.00%. The relapse rate in the treatment group was significantly lower than that in the control group. χ 2 =5.131, P =0.024<0.05). Therefore, the traditional Chinese medicine granules of the present invention have a long-lasting post-treatment effect, can significantly prolong the clinical remission period, and reduce the recurrence rate.

[0121] 6.3 7-point Likert scale 6.3.1 The scores of the 7-point Likert scale in the control group and the treatment group after treatment are shown in Table 9.

[0122] Table 9

[0123] As shown in Table 9, the treatment effect in the treatment group was significantly better than that in the control group during the third and fourth weeks. Therefore, compared with rabeprazole sodium enteric-coated tablets, the traditional Chinese medicine granules of this invention have a stronger cumulative effect, a disease-modifying effect, and a more lasting and fundamental therapeutic effect on NERD.

[0124] 6.3.2 The scores of the 7-point Likert scale in the control group and the treatment group during the follow-up period are shown in Table 10.

[0125] Table 10

[0126] As shown in Table 10, the treatment group's 7-point Likert scale score was significantly lower than that of the control group during the follow-up period. The traditional Chinese medicine granules of this invention have a sustained post-treatment effect, significantly prolonging the clinical remission period and reducing the relapse rate.

[0127] In summary, based on the RDQ scale and the 7-point Likert scale scores, after treatment, in the control group, 1 case was cured, 4 cases showed significant improvement, 19 cases showed improvement, and 6 cases showed no improvement, for a total of 24 effective cases, with an effective rate of 80.00%. In the treatment group, 3 cases were cured, 8 cases showed significant improvement, 14 cases showed improvement, and 5 cases showed no improvement, for a total of 25 effective cases, with an effective rate of 83.33%. The efficacy of the traditional Chinese medicine granules of this invention is comparable to that of rabeprazole sodium enteric-coated tablets. Furthermore, the traditional Chinese medicine granules of this invention have a strong cumulative effect and a low recurrence rate.

[0128] 6.4 Traditional Chinese Medicine Clinical Symptom Scoring Scale 6.4.1 The TCM clinical symptom scores of the control group and the treatment group before treatment are shown in Table 11.

[0129] Table 11

[0130] As shown in Table 11, both groups showed similar performance in the aforementioned six indicators and the total symptom score. P >0.05, indicating no statistically significant difference. This means that the TCM clinical symptom scores of the two groups of patients were comparable before treatment.

[0131] 6.4.2 The TCM clinical symptom scores of the control group before and after treatment are shown in Table 12.

[0132] Table 12

[0133] As shown in Table 12, after treatment, the control group showed significant improvement in symptoms such as acid reflux, chest and rib distension, chest tightness and frequent sighing, mood disturbance and overall symptoms compared to before treatment.

[0134] 6.4.3 The TCM clinical symptom scores of the treatment group before and after treatment are shown in Table 13.

[0135] Table 13

[0136] As shown in Table 13, the symptoms of the treatment group were significantly improved after treatment. The herbal granules of this invention have a very significant therapeutic effect on liver-stomach disharmony syndrome. Furthermore, the herbal granules of this invention can significantly improve the patient's mood.

[0137] 6.4.4 The TCM clinical symptom scores of the control group and the treatment group after treatment are shown in Table 14.

[0138] Table 14

[0139] As shown in Table 14, the Chinese herbal granules of the present invention and the enteric-coated rabeprazole sodium tablets showed that the treatment group was significantly better than the control group in terms of overall symptom improvement and symptoms such as chest and rib distension, chest tightness and frequent sighing, and mood disturbance. The improvement effects of acid reflux, retrosternal pain, and nausea and vomiting were comparable between the two groups.

[0140] According to the Traditional Chinese Medicine Clinical Symptom Scoring Scale, after 4 weeks of treatment, in the control group, 1 case was cured, 3 cases showed significant improvement, 15 cases showed improvement, and 11 cases showed no improvement, for a total of 19 effective cases, with an effective rate of 63.33%. In the treatment group, 4 cases were cured, 6 cases showed significant improvement, 14 cases showed improvement, and 6 cases showed no improvement, for a total of 24 effective cases, with an effective rate of 80.00%. The efficacy of the two groups was compared using the rank-sum test. Z =1.992, P =0.046<0.05, the difference is statistically significant. Therefore, compared with rabeprazole sodium enteric-coated tablets, the traditional Chinese medicine granules of this invention have a significant therapeutic effect on liver-stomach disharmony syndrome.

[0141] 6.5 Health-Related Quality of Life Scale for Gastroesophageal Reflux Disease (GERD-HRQL) 6.5.1 The GERD-HRQL scores of the control group and the treatment group before treatment are shown in Table 15.

[0142] Table 15

[0143] As shown in Table 15, both the control group and the treatment group performed better in all nine indicators and the total score. P >0.05 indicates no statistically significant difference. This means the two groups of patients were comparable before treatment.

[0144] 6.5.2 The GERD-HRQL scores of the control group before and after treatment are shown in Table 16.

[0145] Table 16

[0146] As shown in Table 16, the control group experienced improvement in heartburn-related symptoms and overall lifestyle after treatment. Changes in eating habits, sleep disturbances, and bloating symptoms caused by heartburn also improved.

[0147] 6.5.3 The GERD-HRQL scale scores of the treatment group before and after treatment are shown in Table 17.

[0148] Table 17

[0149] As shown in Table 17, after treatment, the symptoms of the treatment group improved significantly and the quality of life improved significantly, especially in terms of heartburn, abdominal distension and overall quality of life.

[0150] 6.5.4 The GERD-HRQL scores of the control group and the treatment group after treatment are shown in Table 18.

[0151] Table 18

[0152] As shown in Table 18, the abdominal distension and overall quality of life of the patients in the treatment group were significantly improved after treatment. The traditional Chinese medicine granules of this invention can effectively treat liver-stomach disharmony syndrome, especially for patients with indigestion and qi stagnation.

[0153] In summary, after 4 weeks of treatment, the treatment group was superior to the control group (rabeprazole sodium enteric-coated tablet group) in terms of total TCM syndrome score and total effective rate. The total effective rate of TCM syndrome in the treatment group was 80.0%, which was higher than 63.3% in the control group, and the difference between the two groups was statistically significant. P <0.05).

[0154] 7. Safety Evaluation No significant adverse reactions were observed in either group during the treatment. In the control group, one patient had a slightly elevated alanine aminotransferase (ALT) level before treatment, which further increased slightly after treatment. Considering the patient's history of fatty liver disease, this ALT abnormality was considered to be primarily related to fatty liver. No clinically significant abnormalities were observed in laboratory tests, vital signs, or electrocardiograms of the remaining subjects before and after treatment.

[0155] This invention is not limited to the above-described embodiments. Any modifications, improvements, or substitutions that can be conceived by those skilled in the art without departing from the essential content of this invention fall within the scope of this invention.

Claims

1. A traditional Chinese medicine composition for treating gastroesophageal reflux disease, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 3-10 parts by weight, Paeonia lactiflora 3-10 parts by weight, Cyperus rotundus 3-10 parts by weight, Angelica dahurica 3-10 parts by weight, Acorus tatarinowii 3-10 parts by weight, Taraxacum mongolicum 3-10 parts by weight, Coptis chinensis 1-5 parts by weight, Evodia rutaecarpa 1-4 parts by weight, Fritillaria thunbergii 4-12 parts by weight, Pinellia ternata 3-10 parts by weight, Bambusa textilis 4-12 parts by weight, Medicated leaven 4-12 parts by weight, Atractylodes macrocephala 3-10 parts by weight, Citrus aurantium 3-10 parts by weight, and Glycyrrhiza uralensis 1-5 parts by weight.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 5-8 parts by weight, Paeonia lactiflora 5-9 parts by weight, Cyperus rotundus 5-9 parts by weight, Angelica dahurica 5-9 parts by weight, Acorus tatarinowii 5-9 parts by weight, Taraxacum mongolicum 5-9 parts by weight, Coptis chinensis 2-4 parts by weight, Evodia rutaecarpa 1-3 parts by weight, Fritillaria thunbergii 6-10 parts by weight, Pinellia ternata 5-9 parts by weight, Bambusa textilis 5-10 parts by weight, Medicated leaven 5-10 parts by weight, Atractylodes macrocephala 5-9 parts by weight, Citrus aurantium 5-9 parts by weight, and Glycyrrhiza uralensis 2-4 parts by weight.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 3-10 parts by weight, Paeonia lactiflora 3-10 parts by weight, Cyperus rotundus 3-10 parts by weight, Angelica dahurica 3-10 parts by weight, Acorus tatarinowii 3-10 parts by weight, Taraxacum mongolicum 3-10 parts by weight, Coptis chinensis 1-5 parts by weight, Evodia rutaecarpa 1-4 parts by weight, Fritillaria thunbergii 4-12 parts by weight, Pinellia ternata 3-10 parts by weight, Bambusa textilis 4-12 parts by weight, Medicated leaven 4-12 parts by weight, Atractylodes macrocephala 3-10 parts by weight, Citrus aurantium 3-10 parts by weight, and Glycyrrhiza uralensis 1-5 parts by weight.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Bupleurum chinense 6 parts by weight, Paeonia lactiflora 6 parts by weight, Cyperus rotundus 6 parts by weight, Angelica dahurica 6 parts by weight, Acorus tatarinowii 6 parts by weight, Taraxacum mongolicum 6 parts by weight, Coptis chinensis 3 parts by weight, Evodia rutaecarpa 2 parts by weight, Fritillaria thunbergii 8 parts by weight, Pinellia ternata 6 parts by weight, Bambusa textilis 8 parts by weight, Medicated leaven 8 parts by weight, Atractylodes macrocephala 6 parts by weight, Citrus aurantium 6 parts by weight, and Glycyrrhiza uralensis 3 parts by weight. Among them, the Atractylodes macrocephala is stir-fried; the Citrus aurantium is stir-fried; and the Glycyrrhiza uralensis is prepared by roasting.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, Includes the following steps: Each raw material was extracted using water as the extraction solvent, and the extraction was carried out by decoction, reflux extraction, or ultrasonic extraction. The extracts were then concentrated and mixed to obtain a traditional Chinese medicine composition; or the extracts were mixed and concentrated to obtain a traditional Chinese medicine composition.

6. A pharmaceutical preparation for treating gastroesophageal reflux disease, characterized in that, It includes the traditional Chinese medicine composition as described in any one of claims 1 to 4 and pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 6, characterized in that, The pharmaceutical preparation is an oral preparation.

8. A method for preparing a pharmaceutical preparation for treating gastroesophageal reflux disease according to claim 6, characterized in that, Includes the following steps: Each of the raw materials in the traditional Chinese medicine composition according to any one of claims 1 to 4 is extracted using water as the extraction solvent by decoction, reflux extraction, or ultrasonic extraction. The extracts are then concentrated to obtain clear extracts of each component. Excipients are added to the clear extracts of each component, and the components are granulated to obtain component granules. The component granules are then mixed to obtain a pharmaceutical preparation.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the pharmaceutical preparation according to claim 6 in the preparation of a medicament for treating gastroesophageal reflux disease.

10. The use according to claim 9, characterized in that, The gastroesophageal reflux disease mentioned is non-erosive reflux disease, and according to traditional Chinese medicine, it is a syndrome of disharmony between the liver and stomach.

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