A traditional Chinese medicine composition for treating stuffiness and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a traditional Chinese medicine composition for treating fullness and application thereof. The traditional Chinese medicine composition comprises Chaihu, Baishao, Xinyinhua, Yujin, Taizishen, Wuzhimaotao, Fushen, Hehuanpi, Huazao, Jiguangxiang, Tanshang, Bamiaozha, Sharen, Baodoukou, Zixugeng, Lugen, Zhuzu, Dujiaojin, Chao'anyu, Busheye and Danshen. The traditional Chinese medicine composition has the effects of relieving depression and soothing the nerves, invigorating the spleen and tonifying qi, eliminating fullness and relieving distension, and follows the principles of 'treating the same disease with the same method' and 'treating the disease from the root'. The traditional Chinese medicine composition is in accordance with the principle of combination of monarch, minister, assistant and guide, has unique effects on chronic gastritis, functional dyspepsia and gastrointestinal neurosis of the type of liver depression and spleen deficiency, has no adverse reactions, is safe and effective, and is suitable for popularization and application.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations. More specifically, it relates to a traditional Chinese medicine composition for treating distension and fullness and its application. Background Art

[0002] Distension and fullness is a disease syndrome mainly characterized by discomfort and fullness in the epigastric and abdominal regions. The main symptoms are a feeling of distension and fullness in the epigastric region, which is soft when pressed, has no palpable mass, and is painless when pressed. In "Complete Works of Jingyue - Distension and Fullness", it is stated that: "Pi means blocked and unable to open; man means full and unable to move. Generally, fullness is similar to distension, while pi does not necessarily involve distension." Diseases such as chronic gastritis, functional dyspepsia, and gastrointestinal neurosis in modern medicine can all be classified into the category of "distension and fullness". According to traditional Chinese medicine theory, distension and fullness is caused by comprehensive factors such as exogenous pathogenic factors invading the interior, improper diet, phlegm-dampness obstruction, emotional disorders, and weakness of the spleen and stomach. It is commonly a syndrome of deficiency and excess complexity, with spleen deficiency as the root and qi stagnation, fire-heat, food accumulation, and phlegm-fluid retention as the branches. With the increase of pressure in various aspects such as society, work, and life, as well as the changes in eating habits and work and rest patterns, more and more people suffer from spleen and stomach system diseases. Among them, the incidence rate of distension and fullness accounts for the vast majority of patients in the outpatient department of the spleen and stomach department. And this disease is prone to relapse, which not only damages the physical and mental health of patients but also increases their economic burden, thereby reducing their quality of life.

[0003] Chronic gastritis refers to various chronic inflammatory lesions of the gastric mucosa caused by different etiologies. It is the most common digestive system disease in the Chinese population. Clinically, chronic superficial gastritis, chronic erosive gastritis, and chronic atrophic gastritis are commonly seen. According to a large-scale cross-sectional survey in China, among 8,892 patients diagnosed with chronic gastritis by endoscopy, the composition ratios of chronic atrophic gastritis and chronic non-atrophic gastritis are 17.7% and 82.3% respectively. Since most patients with chronic atrophic gastritis have no obvious digestive tract symptoms or have not undergone gastroscopy, the actual prevalence of chronic atrophic gastritis may be higher. It is estimated that the prevalence of chronic atrophic gastritis in the overall Chinese population is higher than 20%. Most chronic superficial gastritis can be reversed, and a small number can turn into chronic atrophic gastritis. If chronic gastritis is not treated in a timely manner, it may develop into gastric ulcer, and even further induce complications such as gastric bleeding, gastric perforation, pyloric obstruction, and gastric cancer.

[0004] Functional dyspepsia is a non-organic disease caused by disorders of the functions of the stomach and duodenum, manifested as symptoms such as postprandial fullness, early satiety, belching, loss of appetite, nausea, vomiting, etc. The onset is generally slow, showing a persistent or recurrent pattern, and can be induced by diet and mental factors. The incidence rate of functional dyspepsia is relatively high. According to the survey results, the prevalence of functional dyspepsia in China has reached 23%, accounting for more than half of the patients in the outpatient department of the spleen and stomach department, and there is still an upward trend every year.

[0005] Gastrointestinal neurosis is a complex digestive system disorder primarily caused by dysfunction of the autonomic nervous system due to impaired higher nervous activity. Symptoms mainly include belching, bloating, acid reflux, nausea, and early satiety, but clinical examinations reveal no organic lesions. If this condition remains untreated for a long period, it often negatively impacts the patient's quality of life.

[0006] Although chronic gastritis, functional dyspepsia, and gastrointestinal neurosis have different names, they are similar in nature and may all present with symptoms such as upper abdominal discomfort, bloating, loss of appetite, belching, acid reflux, and nausea. Clinically, they can be classified under the category of "epigastric fullness" in traditional Chinese medicine. Modern medicine usually treats chronic gastritis with quadruple therapy, which is a combination of a proton pump inhibitor, two antibiotics, and a bismuth preparation (Ismail Rehman, Wen Ning, Zeng Binfang. Research progress on the treatment of chronic atrophic gastritis with integrated traditional Chinese and Western medicine [J]. Xinjiang Journal of Traditional Chinese Medicine, 2023, 41(04):126-130). In the treatment of functional dyspepsia, proton pump inhibitors and prokinetic drugs are often used clinically (Gu Xiaoyan. Observation on the efficacy of Jianpi Liqi Xiaopi Decoction combined with conventional Western medicine in the treatment of functional dyspepsia with spleen deficiency and qi stagnation syndrome [J]. China Journal of Traditional Chinese Medicine Science and Technology, 2023, 30(02):365-367). For gastrointestinal neurosis, clinical treatment mainly involves the use of prokinetic drugs, gastric acid inhibitors, and intestinal flora regulators combined with psychological counseling (Liu Guanping. Clinical observation on the efficacy of acupuncture in the treatment of gastrointestinal neurosis [D]. Heilongjiang University of Traditional Chinese Medicine, 2015). Modern medical treatments for these three diseases are mostly symptomatic, which can only temporarily relieve symptoms, but all have problems such as uncertain efficacy, many side effects, and poor patient tolerance. Summary of the Invention

[0007] The technical problem this invention aims to solve is to overcome the shortcomings and deficiencies of existing drugs in treating epigastric fullness and related diseases, such as insignificant therapeutic effects, numerous side effects, and poor patient tolerance. This invention provides a traditional Chinese medicine composition for treating epigastric fullness and related diseases. This composition conforms to the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine formulation, possessing the effects of relieving depression and calming the mind, strengthening the spleen and replenishing qi, and eliminating epigastric fullness and related diseases. It has unique therapeutic effects on chronic gastritis, functional dyspepsia, and gastrointestinal neurosis diagnosed as liver stagnation and spleen deficiency, fully demonstrating the principles of "treating different diseases with the same method" and "treating the root cause of the disease."

[0008] The purpose of this invention is to provide a traditional Chinese medicine composition for treating abdominal distension and fullness in the preparation of a medicine for treating abdominal distension and fullness caused by liver stagnation and spleen deficiency.

[0009] The above-mentioned objective of this invention is achieved through the following technical solution:

[0010] The core pathogenesis of abdominal distension is liver dysfunction and spleen dysfunction. The spleen and stomach reside in the middle jiao (middle burner), serving as the pivot of the body's qi movement. The spleen governs transformation and transportation, while the stomach governs reception; together they manage the digestion, absorption, and distribution of food and water. The spleen governs the ascending of clear qi, while the stomach governs the descending of turbid qi; when clear qi ascends and turbid qi descends, the qi movement is smooth. The liver governs the free flow of qi, regulating the qi movement of the spleen and stomach. When liver qi flows smoothly, spleen qi ascends and stomach qi descends, resulting in smooth qi flow. The liver belongs to wood, while the spleen and stomach belong to earth. Wood has the function of regulating earth, but also the nature of restraining earth. Earth is aided by wood, as stated in *Treatise on Blood Disorders: On the Pathogenesis of Zang-Fu Organs*: "The nature of wood is to regulate and disperse. Food qi enters the stomach, entirely relying on the liver wood qi to regulate and disperse it, so that food and water can be transformed. If the clear yang of the liver does not ascend, it cannot regulate and disperse food and water, and the symptoms of abdominal distension are inevitable." In a pathological state, when liver qi fails to regulate and disperse, it inevitably attacks the spleen earth. When the spleen and stomach are deficient in qi, their digestive and absorptive functions are impaired, leading to disordered ascending and descending of qi in the middle jiao. The spleen fails to ascend clear qi, and the stomach loses its descending function, resulting in qi stagnation and fullness in the middle jiao. Therefore, imbalances in the spleen, stomach, and liver can all impair the qi flow in the middle jiao, causing spleen and stomach dysfunction and resulting in abdominal distension. Thus, treatment for abdominal distension should focus on the liver and spleen. Furthermore, clinical practice has demonstrated that traditional Chinese medicine has unique advantages in treating diseases related to abdominal distension, such as chronic gastritis, functional dyspepsia, and gastrointestinal neurosis, with high efficacy and minimal side effects.

[0011] Based on this, the present invention provides a traditional Chinese medicine composition for treating abdominal distension, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 3-10 parts of vinegar-processed Bupleurum chinense, 6-15 parts of Paeonia lactiflora, 5-10 parts of Jasminum sambac, 5-12 parts of Curcuma longa, 9-30 parts of Codonopsis pilosula, 15-30 parts of Ficus hirta, 9-15 parts of Poria cocos, 6-15 parts of Albizia julibrissin bark, 3-6 parts of Citrus reticulata peel, 6-15 parts of Angelica dahurica, 2-5 parts of Santalum album, 9-15 parts of Akebia quinata, 3-6 parts of Amomum villosum, 3-6 parts of Amomum cardamomum, 5-10 parts of Perilla frutescens stem, 5-10 parts of Areca catechu peel, 15-30 parts of Phragmites communis rhizome, 5-10 parts of Bambusa textilis shavings, 5-25 parts of Lepidium apetalum, 9-15 parts of stir-fried rice sprouts, 9-15 parts of Polygonum cuspidatum, 15-30 parts of Buzkabirica leaf, and 6-15 parts of Salvia miltiorrhiza.

[0012] Explanation of the formula of the traditional Chinese medicine composition of this invention:

[0013] In this formula, vinegar-processed Bupleurum chinense effectively soothes the liver, regulates Qi, raises Yang, and harmonizes the exterior and interior. The *Shennong Bencao Jing* states, "Bupleurum chinense is light and clear, rising and reaching the gallbladder Qi. When the gallbladder Qi flows smoothly, the eleven organs can follow its function, thus dispersing any stagnant Qi in the heart, abdomen, intestines, and stomach." Codonopsis pilosula invigorates Qi, strengthens the spleen, generates fluids, and moistens the lungs. Together, these two herbs serve as the principal herbs, achieving the effects of soothing the liver, relieving depression, strengthening the spleen, and invigorating Qi. Ficus hirta strengthens the spleen and lungs, further enhancing the spleen-tonifying and Qi-invigorating effects of Codonopsis pilosula. Paeonia lactiflora, slightly bitter and sour, also enters the liver meridian, nourishing blood and astringing Yin, with a tendency towards astringency. Vinegar-processed Bupleurum chinense and Paeonia lactiflora complement each other, one soothing and one astringent, resulting in synergistic effects. This prevents liver Qi stagnation and ensures the preservation of Yin blood, working together to soothe the liver without harming Yin blood and astringe the liver without stagnation of Qi. These two herbs serve as assistant herbs, assisting the principal herbs in enhancing the effects of soothing the liver, relieving depression, nourishing Yin, strengthening the spleen, and invigorating Qi. Jasmine, turmeric, Poria cocos, Albizia julibrissin bark, Citrus reticulata peel, Angelica dahurica, sandalwood, Akebia quinata, Amomum villosum, Amomum cardamomum, Perilla frutescens stem, Areca catechu peel, Phragmites communis rhizome, bamboo shavings, Strigaria heterophylla, roasted rice sprouts, Polygonum cuspidatum, and Broussonetia papyrifera leaf are used as adjuvant herbs. When liver qi is impaired, leading to emotional depression and insomnia, jasmine and turmeric are used to soothe the liver, relieve depression, and regulate qi. Poria cocos and Albizia julibrissin bark calm the mind, soothe the nerves, and aid sleep. When the spleen and stomach's ascending and descending functions are disrupted, causing qi stagnation, abdominal distension, and discomfort, Citrus reticulata peel, Angelica dahurica, sandalwood, and Akebia quinata are used to regulate qi and relieve stagnation. Amomum villosum has a pungent and turbid qi, while Amomum cardamomum is fragrant and clear; these two herbs are used together. This formula promotes the flow of Qi in the upper, middle, and lower Jiao (three burners), opening the chest and regulating Qi, relieving pain, dispelling turbidity, invigorating the spleen and stomach, and harmonizing the middle Jiao to aid digestion. Perilla stem excels at regulating Qi and is effective in harmonizing the middle Jiao. Areca peel has a downward-moving nature, resolving dampness and stagnant Qi, relieving bloating, and these two herbs enhance the effects of regulating Qi, relieving bloating, and eliminating distension. Reed rhizome invigorates the stomach and stops vomiting, while bamboo shavings relieve nausea and vomiting; their combined effect further enhances this effect. Due to spleen and stomach dysfunction, food stagnation is common, so *Striga asiatica* and roasted rice sprouts are added to aid digestion and eliminate food stagnation. *Polygonum cuspidatum* and *Broussonetia papyrifera* leaves are both excellent Lingnan herbs, functioning to eliminate dampness and stagnation, aligning with the spleen's preference for dryness and aversion to dampness. Based on the theory that "Qi is the commander of blood, and blood is the mother of Qi," *Salvia miltiorrhiza* is added to promote Qi, invigorate blood, and relieve stagnation, serving as the guiding herb. The combined effects of these herbs are balanced, nourishing without causing stagnation, and warming without causing dryness, achieving the combined effects of relieving depression and calming the mind, strengthening the spleen and replenishing Qi, and eliminating bloating and distension.

[0014] The medicinal properties of the traditional Chinese medicine used in this invention are as follows:

[0015] Vinegar-processed Bupleurum: Pungent and bitter in taste, slightly cold in nature; it enters the liver, gallbladder, and lung meridians. It has the effects of harmonizing the exterior and interior, soothing the liver and relieving depression, raising yang and lifting prolapse, and reducing fever and stopping malaria. It is mainly used to treat colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse. Modern pharmacological studies have shown that vinegar-processed Bupleurum can increase bile secretion, has good anti-fatty liver and transaminase effects, and has a significant protective effect against experimental liver injury.

[0016] White peony root: bitter and sour in taste, slightly cold in nature; it enters the liver and spleen meridians. It has the effects of nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening the liver and relieving pain, and calming liver yang. It is mainly used to treat blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache, and dizziness. Modern pharmacological research shows that white peony root has hepatoprotective, hematopoietic-promoting, liver-damaging, sedative, antidepressant, gastrointestinal-regulating, anti-ischemic, and anti-inflammatory effects.

[0017] Jasmine flower: Bitter in taste, neutral in nature; enters the liver meridian. It has the effects of soothing the liver and relieving depression, promoting qi circulation and relieving pain. It is mainly used to treat pain in the hypochondrium and abdomen, and abdominal pain due to diarrhea caused by liver qi stagnation. Modern pharmacological studies have shown that jasmine flower has antispasmodic and antitumor effects.

[0018] Turmeric: pungent and bitter in taste, cold in nature; enters the liver, heart, and lung meridians. It has the effects of promoting blood circulation and relieving pain, regulating qi and relieving depression, clearing heat from the heart and cooling the blood, and promoting bile secretion and reducing jaundice. It is mainly used to treat amenorrhea and dysmenorrhea, chest and abdominal distension and pain, febrile delirium, epilepsy with mania, jaundice, and dark urine. Modern pharmacological studies have shown that turmeric has immunosuppressive, anti-allergic, hepatoprotective, choleretic, gastric acid-inhibiting, lipid metabolism-promoting, arterial plaque-inhibiting, anticoagulant, platelet-aggregating, analgesic, and hypnotic effects.

[0019] Codonopsis pilosula: Sweet and slightly bitter in taste, neutral in nature; enters the spleen and lung meridians. It has the effects of invigorating qi and strengthening the spleen, promoting body fluid production and moistening the lungs. It is mainly used to treat spleen deficiency with fatigue, loss of appetite, weakness after illness, qi and yin deficiency, spontaneous sweating with thirst, and dry cough due to lung dryness. Modern pharmacological studies have shown that Codonopsis pilosula has the effects of enhancing immune function, improving memory, anti-stress, anti-fatigue, improving small intestine absorption, lowering blood sugar, lowering blood lipids, antibacterial, antitussive, antiviral, expectorant, and anti-inflammatory effects.

[0020] Five-finger peach (Ficus hirta): Slightly warm in nature and sweet in taste; it enters the lung, spleen, stomach, large intestine, and liver meridians. It has the effects of invigorating qi and strengthening the spleen, resolving phlegm and relieving asthma, promoting qi circulation and eliminating dampness, and relaxing muscles and tendons. It is mainly used to treat cough with phlegm due to lung deficiency, fatigue and weakness of limbs due to spleen and stomach qi deficiency, poor appetite and abdominal distension, edema due to spleen deficiency, leukorrhea, rheumatic pain, and lower back and leg pain. Modern pharmacological research shows that five-finger peach has a protective effect on the gastrointestinal tract and liver, can improve immune function, and has antioxidant, anti-radiation, and anti-aging effects.

[0021] Poria cocos (Fu Shen): Sweet in taste and neutral in nature; it enters the heart and spleen meridians. It has the effects of calming the mind and soothing the nerves, promoting diuresis and reducing swelling, and strengthening the spleen and stomach. It is mainly used to treat palpitations due to heart deficiency, forgetfulness, insomnia, epilepsy, and difficulty urinating. Modern pharmacological research shows that Poria cocos has an improving effect on gastrointestinal indigestion.

[0022] Albizia bark: sweet in taste and neutral in nature; it enters the heart, liver, and lung meridians. It has the effects of relieving depression and calming the mind, promoting blood circulation and reducing swelling. It is mainly used to treat restlessness, depression and insomnia, lung abscesses and sores, and injuries from falls. Modern pharmacological studies have shown that Albizia bark has sedative, antidepressant, immune-enhancing, and antitumor pharmacological effects.

[0023] Huajuhong (Citrus reticulata peel): pungent and bitter in taste, warm in nature; enters the lung and spleen meridians. It has the effects of regulating qi and relieving chest congestion, resolving phlegm and relieving cough, and strengthening the spleen and promoting digestion. It is mainly used to treat phlegm stagnation in the chest, cough and asthma, vomiting and hiccups, and food stagnation. Modern pharmacological research shows that Huajuhong has the effects of promoting gastric juice secretion, anti-inflammatory, antitussive and expectorant effects.

[0024] Chicken Bone Fragrance: Slightly bitter and pungent in taste, warm in nature; it enters the heart, lung, liver, stomach, and kidney meridians. It has the effects of regulating qi and relieving pain, dispelling wind and dampness, and reducing swelling and pain. It is mainly used to treat abdominal distension and pain, rheumatic pain, hernia pain, dysmenorrhea, sore throat, and traumatic swelling and pain. Modern pharmacological studies have shown that Chicken Bone Fragrance has significant anti-tumor, anti-inflammatory, analgesic, and antibacterial physiological activities.

[0025] Sandalwood: pungent in taste and warm in nature; it enters the spleen, stomach, heart, and lung meridians. It has the functions of regulating qi and warming the middle jiao, stimulating appetite and relieving pain. It is mainly used to treat cold stagnation of qi, chest pain, abdominal pain, stomach pain and poor appetite; coronary heart disease, angina pectoris. Modern pharmacological studies have shown that sandalwood can enhance gastrointestinal motility and promote the secretion of digestive juices.

[0026] Akebia quinata: Sweet in taste and cold in nature; it enters the liver, stomach, and bladder meridians. It has the effects of soothing the liver and stomach, promoting blood circulation and relieving pain, softening and dispersing nodules, and promoting urination. It is mainly used to treat liver and stomach qi stagnation, abdominal and hypochondriac distension and pain, indigestion, diarrhea, hernia pain, lower back pain, amenorrhea, and dysmenorrhea. Modern pharmacological studies have shown that Akebia quinata has antibacterial, anti-inflammatory, and liver-protective effects, and is very effective in treating hepatitis and gastric ulcers.

[0027] Amomum villosum: pungent in flavor and warm in nature; it enters the spleen, stomach, and kidney meridians. It has the effects of resolving dampness and stimulating appetite, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. It is mainly used to treat dampness obstructing the middle jiao, epigastric fullness and lack of appetite, spleen and stomach deficiency and cold, vomiting and diarrhea, morning sickness, and threatened abortion. Modern pharmacological studies have shown that Amomum villosum has the effects of regulating gastrointestinal function and anti-inflammatory and analgesic properties.

[0028] White cardamom: pungent in flavor and warm in nature; it enters the lung, spleen, and stomach meridians. It has the effects of resolving dampness and relieving stagnation, regulating qi and warming the middle jiao, and stimulating appetite and digestion. It is mainly used to treat dampness obstructing the middle jiao, loss of appetite, early stages of damp-heat syndrome, chest tightness and lack of hunger, nausea and vomiting due to cold-dampness, chest and abdominal distension and pain, and indigestion. Modern pharmacological studies have shown that white cardamom can promote gastric juice secretion, stimulate intestinal peristalsis, expel intestinal gas, and inhibit abnormal fermentation in the intestines, thus having good stomach-strengthening and antiemetic effects.

[0029] Perilla stem: pungent in flavor and warm in nature; it enters the lung and spleen meridians. It has the effects of regulating qi, relieving chest tightness, alleviating pain, and calming the fetus. It is mainly used to treat chest tightness, stomach pain, belching and vomiting, and threatened miscarriage. Modern pharmacological studies have shown that perilla stem can promote the motility of gastrointestinal smooth muscle.

[0030] Areca Peel: Pungent in taste and slightly warm in nature; it acts on the spleen, stomach, large intestine and small intestine meridians. It has the effects of promoting qi circulation to relieve distension and promoting diuresis to reduce edema. It is mainly used to treat dampness obstruction with qi stagnation, fullness and stuffiness in the epigastric and abdominal regions, unsmooth defecation, edema and distension, beriberi edema, and dysuria. Modern pharmacological research shows that areca peel mainly acts on the contraction of the large intestine smooth muscle, can increase the intestinal tension, and promote gastrointestinal motility.

[0031] Rhizoma Phragmitis: Sweet in taste and cold in nature; it acts on the lung and stomach meridians. It has the effects of clearing heat and promoting fluid production, removing vexation, stopping vomiting, and inducing diuresis. It is mainly used to treat febrile disease with dysphoria and thirst, vomiting due to stomach heat, cough due to lung heat, lung abscess with expectoration, and stranguria with pain due to heat. Modern pharmacological research shows that rhizoma phragmitis has antipyretic, sedative, analgesic, blood pressure-lowering, blood sugar-lowering, antioxidant and estrogen-like effects, and has an inhibitory effect on β-hemolytic streptococcus.

[0032] Caulis Bambusae in Taeniam: Sweet in taste and slightly cold in nature; it acts on the lung and stomach meridians. It has the effects of clearing heat and resolving phlegm, removing vexation and stopping vomiting. It is mainly used to treat cough due to phlegm-heat, phlegm-fire with bile involvement, vexation and vomiting, vomiting due to stomach heat, morning sickness during pregnancy, and restlessness of the fetus. Modern pharmacological research shows that caulis bambusae in taeniam has pharmacological effects such as reducing blood lipid, anti-fatigue, regulating digestive function, promoting bile secretion and inducing diuresis.

[0033] Striga asiatica (L.) Kuntze: Sweet and light in taste, cool in nature; it acts on the kidney, spleen and liver meridians. It has the effects of calming the liver and eliminating infantile malnutrition, strengthening the spleen and promoting digestion, clearing heat and inducing diuresis. It is mainly used to treat infantile malnutrition, infantile summer fever, infantile diarrhea, and icterohepatitis. Modern pharmacological research shows that striga asiatica (L.) kuntze can improve digestive function, promote appetite and regulate the balance of intestinal flora.

[0034] Fried Fructus Oryzae Germinatus: Sweet in taste and warm in nature; it acts on the spleen and stomach meridians. It has the effects of regulating the middle-jiao to promote digestion and strengthening the spleen to promote appetite. It is mainly used to treat indigestion, abdominal distension and halitosis, weakness of the spleen and stomach, and anorexia. Modern pharmacological research shows that fried fructus oryzae germinatus has effects such as promoting digestion, reducing blood sugar, and antifungal.

[0035] Herba Polygoni Chinensis: Slightly sour and astringent in taste, cool in nature; it acts on the liver and spleen meridians. It has the effects of clearing heat and detoxifying, promoting diuresis and eliminating stagnation, cooling blood and relieving itching, and removing nebula and improving eyesight. It is mainly used to treat dysentery, enteritis, indigestion, hepatitis, colds, etc. Modern pharmacological research shows that herba polygoni chinensis has effects such as anti-inflammatory and analgesic, antioxidant, anti-hepatitis B virus, antibacterial, and anti-diarrhea.

[0036] Folium Microcos: Slightly sour in taste, cool in nature; it acts on the spleen and stomach meridians. It has the effects of promoting digestion and resolving stagnation, clearing heat and promoting diuresis. It is mainly used to treat food retention, common cold with fever, and jaundice due to damp-heat. Modern pharmacological research shows that folium microcos has effects such as antioxidant, blood lipid-lowering, analgesic, anti-inflammatory, protecting the cardiovascular system, and antipyretic.

[0037] Danshen (Salvia miltiorrhiza): Bitter in taste and slightly cold in nature; it enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is mainly used to treat chest pain, abdominal pain, abdominal masses, painful arthralgia, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling. Modern pharmacological studies have shown that Danshen has effects such as protecting the myocardium, dilating blood vessels, resisting atherosclerosis, and preventing thrombosis.

[0038] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-10 parts of vinegar-processed Bupleurum chinense, 9-15 parts of Paeonia lactiflora, 6-10 parts of Jasminum sambac, 6-12 parts of Curcuma longa, 10-30 parts of Codonopsis pilosula, 20-30 parts of Ficus hirta, 9-12 parts of Poria cocos, 6-12 parts of Albizia julibrissin bark, 4-6 parts of Citrus reticulata peel, 9-15 parts of Artemisia argyi, 3-5 parts of Santalum album, 9-12 parts of Akebia quinata, 4-6 parts of Amomum villosum, 4-6 parts of Amomum cardamomum, 6-10 parts of Perilla frutescens stem, 6-10 parts of Areca catechu peel, 15-20 parts of Phragmites communis rhizome, 6-10 parts of Bambusa textilis shavings, 6-25 parts of Leonurus japonicus, 9-12 parts of stir-fried rice sprouts, 9-12 parts of Polygonum cuspidatum, 15-25 parts of Buzkabirica leaf, and 6-12 parts of Salvia miltiorrhiza.

[0039] More preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-10 parts of vinegar-processed Bupleurum chinense, 12-15 parts of Paeonia lactiflora, 6-9 parts of Jasminum sambac, 6-9 parts of Curcuma longa, 10-20 parts of Codonopsis pilosula, 25-30 parts of Ficus hirta, 9-10 parts of Poria cocos, 6-10 parts of Albizia julibrissin bark, 4-5 parts of Citrus reticulata peel, 10-15 parts of Artemisia argyi, 3-4 parts of Santalum album, 9-10 parts of Akebia quinata, 5-6 parts of Amomum villosum, 5-6 parts of Amomum cardamomum, 6-9 parts of Perilla frutescens stem, 9-10 parts of Areca catechu peel, 15-20 parts of Phragmites communis rhizome, 9-10 parts of Bambusa textilis shavings, 6-15 parts of Leonurus japonicus, 9-10 parts of stir-fried rice sprouts, 9-10 parts of Polygonum cuspidatum, 15-20 parts of Buzkabirica leaf, and 6-10 parts of Salvia miltiorrhiza.

[0040] Specifically, the traditional Chinese medicine composition includes the following raw materials in parts by weight: 9 parts vinegar-processed Bupleurum chinense, 15 parts white peony root, 6 parts jasmine flower, 6 parts turmeric, 15 parts codonopsis pilosula, 30 parts five-finger peach, 10 parts Poria cocos, 9 parts Albizia julibrissin bark, 5 parts Citrus reticulata peel, 12 parts chicken bone incense, 3 parts sandalwood, 10 parts Akebia quinata, 6 parts Amomum villosum, 6 parts white cardamom, 6 parts perilla stem, 10 parts Areca peel, 15 parts reed rhizome, 9 parts bamboo shavings, 10 parts single-stranded golden needle, 10 parts stir-fried rice sprouts, 10 parts Polygonum cuspidatum, 20 parts Buzkabirica leaf, and 10 parts Salvia miltiorrhiza.

[0041] This invention also protects an oral preparation of traditional Chinese medicine, which includes the traditional Chinese medicine composition described in this invention.

[0042] Furthermore, the oral preparation is a decoction, granules, capsules, tablets, pills, or oral liquid.

[0043] Meanwhile, this invention protects the use of the traditional Chinese medicine composition in the preparation of a medicine for treating abdominal distension due to liver stagnation and spleen deficiency.

[0044] Preferably, the liver stagnation and spleen deficiency type abdominal distension is a symptom of chronic gastritis, functional dyspepsia, or gastrointestinal neurosis.

[0045] The present invention has the following beneficial effects:

[0046] The traditional Chinese medicine composition of this invention includes vinegar-processed Bupleurum chinense, Paeonia lactiflora, Jasminum sambac, Curcuma longa, Pseudostellaria heterophylla, Ficus hirta, Poria cocos, Albizia julibrissin bark, Citrus reticulata peel, Artemisia argyi, Sandalwood, Akebia quinata, Amomum villosum, Amomum cardamomum, Perilla frutescens stem, Areca catechu peel, Phragmites communis rhizome, Bambusa textilis shavings, Strigaria heterophylla, stir-fried Oryza sativa sprouts, Polygonum cuspidatum, Bulbus buergerianum leaf, and Salvia miltiorrhiza. It conforms to the traditional Chinese medicine principle of "principal, assistant, adjuvant, and guide" in herbal formulation, with each component complementing the others to achieve the effects of relieving depression and calming the mind, strengthening the spleen and replenishing qi, and eliminating abdominal distension and fullness. Clinical trials have shown that the traditional Chinese medicine composition of this invention has good therapeutic effects on chronic gastritis, functional dyspepsia, and gastrointestinal neurosis of the liver-stagnation and spleen-deficiency type, with a total effective rate of over 93%, and no adverse reactions were observed, making it suitable for widespread application. Furthermore, the traditional Chinese medicine composition of this invention uses readily available herbs as raw materials, offering advantages such as low cost and ease of preparation. Detailed Implementation

[0047] The present invention will be further illustrated below with reference to specific embodiments, but the embodiments do not limit the present invention in any way. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in this technical field.

[0048] Unless otherwise specified, all reagents and materials used in the following examples are commercially available.

[0049] Example 1: A traditional Chinese medicine decoction for treating abdominal distension.

[0050] The formula of the traditional Chinese medicine composition is as follows: 9g of vinegar-processed Bupleurum chinense, 15g of Paeonia lactiflora, 6g of Jasminum sambac, 6g of Curcuma longa, 15g of Codonopsis pilosula, 30g of Ficus hirta, 10g of Poria cocos, 9g of Albizia julibrissin bark, 5g of Citrus reticulata peel, 12g of Angelica dahurica, 3g of Santalum album, 10g of Akebia quinata, 6g of Amomum villosum, 6g of Amomum cardamomum, 6g of Perilla frutescens stem, 10g of Areca catechu peel, 15g of Phragmites communis rhizome, 9g of Bambusa textilis, 15g of Leonurus japonicus, 10g of stir-fried rice sprouts, 10g of Polygonum cuspidatum, 20g of Buzkabanum jasminoides leaf, and 10g of Salvia miltiorrhiza.

[0051] Preparation method of decoction: Place one dose of Chinese medicine in 1000mL of water and soak for about 30 minutes. First, bring to a boil over high heat, then reduce to a simmer and cook for about 25 minutes. Filter to remove the dregs. The resulting decoction is the required Chinese medicine. One dose is decocted twice, yielding a total of 400-600mL of decoction, which is the daily dose.

[0052] Example 2: A traditional Chinese medicine decoction for treating abdominal distension

[0053] The formula of the traditional Chinese medicine composition is as follows: 10g of vinegar-processed Bupleurum chinense, 12g of Paeonia lactiflora, 5g of Jasminum sambac, 12g of Curcuma longa, 15g of Codonopsis pilosula, 25g of Ficus hirta, 9g of Poria cocos, 9g of Albizia julibrissin bark, 5g of Citrus reticulata peel, 10g of Angelica dahurica, 3g of Santalum album, 9g of Akebia quinata, 6g of Amomum villosum, 6g of Amomum cardamomum, 6g of Perilla frutescens stem, 6g of Areca catechu peel, 20g of Phragmites communis rhizome, 10g of Bambusa textilis shavings, 15g of Leonurus japonicus, 10g of stir-fried rice sprouts, 9g of Polygonum cuspidatum, 20g of Buzkabanum chinense leaf, and 12g of Salvia miltiorrhiza.

[0054] Preparation method of decoction: Same as in Example 1.

[0055] Example 3: A traditional Chinese medicine decoction for treating abdominal distension.

[0056] The formula of the traditional Chinese medicine composition is as follows: 10g of vinegar-processed Bupleurum chinense, 15g of Paeonia lactiflora, 6g of Jasminum sambac, 6g of Curcuma longa, 15g of Codonopsis pilosula, 20g of Ficus hirta, 15g of Poria cocos, 10g of Albizia julibrissin bark, 6g of Citrus reticulata peel, 10g of Angelica dahurica, 3g of Santalum album, 9g of Akebia quinata, 6g of Amomum villosum, 6g of Amomum cardamomum, 6g of Perilla frutescens stem, 10g of Areca catechu peel, 25g of Phragmites communis rhizome, 10g of Bambusa textilis shavings, 25g of Leonurus japonicus, 15g of stir-fried rice sprouts, 9g of Polygonum cuspidatum, 25g of Buzka arvense leaf, and 6g of Salvia miltiorrhiza.

[0057] Preparation method of decoction: Same as in Example 1.

[0058] Example 4: A traditional Chinese medicine composition granule for treating abdominal distension

[0059] The weight proportions of the traditional Chinese medicine composition are as follows: 9 parts vinegar-processed Bupleurum chinense, 15 parts white peony root, 6 parts jasmine flower, 6 parts turmeric, 15 parts codonopsis pilosula, 30 parts five-finger peach, 10 parts Poria cocos, 9 parts Albizia julibrissin bark, 5 parts Citrus reticulata peel, 12 parts chicken bone incense, 3 parts sandalwood, 10 parts Akebia quinata, 6 parts Amomum villosum, 6 parts white cardamom, 6 parts perilla stem, 10 parts Areca peel, 15 parts reed rhizome, 9 parts bamboo shavings, 10 parts single-stranded golden needle, 10 parts stir-fried rice sprouts, 10 parts Polygonum cuspidatum, 20 parts Buzkabirica leaf, and 10 parts Salvia miltiorrhiza.

[0060] Granule preparation method:

[0061] S1. Prepare the following ingredients according to the above formula in the specified weight proportions: vinegar-processed Bupleurum chinense, white peony root, jasmine flower, turmeric, codonopsis pilosula, five-finger peach, poria cocos, albizia bark, tangerine peel, chicken bone incense, sandalwood, akebia quinata, amomum villosum, white cardamom, perilla stem, areca peel, reed rhizome, bamboo shavings, single-stripe gold, stir-fried rice sprouts, fire charcoal motherwort, broom leaves, and salvia miltiorrhiza. Wash them, put them into a multi-functional extraction tank, add water and decoct twice, the first time for 2 hours and the second time for 1.5 hours. Combine the decoctions, filter, concentrate the filtrate, add alcohol to make the alcohol content reach 50%, stir well, let stand at 2-6℃ for 24 hours, filter, recover the ethanol from the filtrate, concentrate, and perform paste collection treatment in a timely manner. After vacuum drying, pulverize, pass through an 80-mesh sieve, mix well, and obtain dry extract powder.

[0062] S2. Mix dry extract powder, dextrin, and sucrose powder in a ratio of 1:0.5:1, moisten with an appropriate amount of ethanol to form granules, dry at below 80℃, granulate, sterilize, and package into bags to obtain granules.

[0063] Example 5: A traditional Chinese medicine composition capsule for treating abdominal distension

[0064] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0065] Capsule preparation method:

[0066] S1. Same as Example 4;

[0067] S2. Mix dry extract powder, dextrin, and sucrose powder in a ratio of 1:0.5:1, moisten with an appropriate amount of ethanol to granulate, dry at below 80℃, granulate, fill into capsules, sterilize, and package to obtain capsules.

[0068] Example 6: A traditional Chinese medicine composition tablet for treating abdominal distension

[0069] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0070] Preparation method of tablet-shaped traditional Chinese medicine composition:

[0071] S1. Same as Example 4;

[0072] S2. Mix dry extract powder, dextrin, and sucrose powder in a ratio of 1:0.5:1, moisten with an appropriate amount of ethanol to granulate, dry at below 80℃, granulate, compress, sterilize, and package to obtain tablets.

[0073] Example 7: A traditional Chinese medicine composition pill for treating abdominal distension

[0074] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0075] Preparation method of the traditional Chinese medicine composition for pills: Prepare the following ingredients according to the weight proportions of the above formula: vinegar-processed Bupleurum chinense, white peony root, jasmine flower, turmeric, codonopsis pilosula, five-finger peach, poria cocos, albizia bark, tangerine peel, chicken bone incense, sandalwood, akebia quinata, amomum villosum, white cardamom, perilla stem, areca peel, reed rhizome, bamboo shavings, single-stranded golden needle, stir-fried rice sprouts, firethorn, broom leaves, and salvia miltiorrhiza. Wash, dry, pulverize, and sieve to obtain powder for later use. Add water and refined honey to the powder, with a mass ratio of powder, refined honey, and water of 10:3:30. Stir until homogeneous, then add to a mold to obtain a pill-shaped traditional Chinese medicine composition with a particle size of 3-6 mm. Sterilize and package to obtain the pills.

[0076] Example 8: A traditional Chinese medicine oral liquid for treating abdominal distension

[0077] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0078] Preparation method of oral liquid of traditional Chinese medicine composition: Prepare the following ingredients according to the weight proportions of the above formula: vinegar-processed Bupleurum chinense, white peony root, jasmine flower, turmeric, codonopsis pilosula, five-finger peach, poria cocos, albizia bark, tangerine peel, chicken bone incense, sandalwood, akebia quinata, amomum villosum, white cardamom, perilla stem, areca peel, reed rhizome, bamboo shavings, single-stripe gold, stir-fried rice sprouts, firethorn, broom leaves, and salvia miltiorrhiza. Wash them, put them into a multi-functional extraction tank, add water and decoct twice, the first time for 2 hours and the second time for 1.5 hours. Combine the decoctions, filter, concentrate the filtrate, add alcohol to make the alcohol content reach 75%, stir well, let stand at 2-6℃ for 24 hours, filter, recover the ethanol from the filtrate, concentrate under reduced pressure to a thick paste, add an appropriate amount of monosaccharide syrup and sodium benzoate, dilute with water, mix well, cool, filter again, fill the original solution into a container, sterilize, and package to obtain the oral liquid preparation.

[0079] Comparative Example 1

[0080] Formula: The only difference from Example 1 is that vinegar-processed Bupleurum is replaced with raw Bupleurum, and white peony is replaced with red peony.

[0081] Preparation method: Same as in Example 1.

[0082] Comparative Example 2

[0083] Formula: The only difference from Example 1 is that the ingredients of Codonopsis pilosula and Prunus cerasifera are omitted.

[0084] Preparation method: Same as in Example 1.

[0085] This invention is applicable to: chronic gastritis, functional dyspepsia, and gastrointestinal neurosis diagnosed as liver stagnation and spleen deficiency.

[0086] Not for use by pregnant women.

[0087] Clinical validation: The decoction of traditional Chinese medicine composition for treating abdominal distension prepared in Example 1, Comparative Example 1 and Comparative Example 2 of the present invention was used in a clinical research program to further validate the beneficial effects of the present invention.

[0088] Experimental Example 1: The therapeutic effect of a traditional Chinese medicine composition on chronic gastritis

[0089] 1. Clinical subjects: 128 patients with chronic gastritis of the liver-stagnation and spleen-deficiency type were included in this study. They were randomly divided into a control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group, with 32 patients in each group. There were no significant differences among the groups in terms of age, gender, and disease duration.

[0090] The control group received routine Western medicine treatment: esomeprazole magnesium enteric-coated tablets, 20 mg twice daily before meals; amoxicillin dispersible tablets, 1 g twice daily after meals; clarithromycin sustained-release capsules, 0.5 g twice daily after meals; and bismuth potassium citrate capsules, 0.6 g twice daily after meals. The other three groups received the drug components from Example 1, Comparative Example 1, and Comparative Example 2, respectively (traditional Chinese medicine decoction, oral administration, one dose daily, divided into two warm doses, approximately 200-300 mL each time). Each group received treatment for 2 weeks as one course, for a total of one course of treatment.

[0091] 2. Diagnostic criteria:

[0092] Western medicine diagnostic criteria: Refer to the diagnostic criteria of the "Chinese Consensus Opinion on Chronic Gastritis" and the "Trial Opinions on Endoscopic Classification and Grading Standards and Treatment of Chronic Gastritis".

[0093] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria in the "Expert Consensus Opinion on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine (2017)".

[0094] 3. Efficacy evaluation criteria:

[0095] The clinical syndrome efficacy evaluation form for patients with chronic gastritis in this trial was developed with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". The total score of patients' clinical symptoms and signs was calculated based on the clinical syndrome efficacy evaluation form, and the percentage improvement was assessed using the following formula:

[0096] Therapeutic effect index = [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100%

[0097] Therapeutic effect evaluation: (1) Clinical cure: TCM clinical symptoms and signs disappear or basically disappear, efficacy index ≥ 95%; (2) Significant effect: TCM clinical symptoms and signs are significantly improved, 70% ≤ efficacy index < 95%; (3) Effective: TCM clinical symptoms and signs are all improved, 30% ≤ efficacy index < 70%; (4) Ineffective: TCM clinical symptoms and signs are not significantly improved, or even aggravated, efficacy index < 30%.

[0098] Overall efficacy (total effective rate) = (total number of cases - number of ineffective cases) / total number of cases × 100%.

[0099] 4. Treatment Results

[0100] After the treatment course, in Example 1 group, 10 cases were cured, 16 cases showed significant improvement, 4 cases were effective, and 2 cases were ineffective, with a total effective rate of 93.75%; in Comparative Example 1 group, 5 cases were cured, 12 cases showed significant improvement, 10 cases were effective, and 5 cases were ineffective, with a total effective rate of 84.38%; in Comparative Example 2 group, 3 cases were cured, 8 cases showed significant improvement, 14 cases were effective, and 7 cases were ineffective, with a total effective rate of 78.13%; in the control group, 1 case was cured, 3 cases showed significant improvement, 19 cases were effective, and 9 cases were ineffective, with a total effective rate of 71.88%. Furthermore, no adverse reactions were observed in patients treated with the herbal composition of this invention after the treatment course. The above results show that the total effective rate of Example 1 group was higher than that of other groups after treatment, indicating that the herbal preparation prepared using the raw materials and preparation method of this invention has a better effect on treating chronic gastritis of the liver-stagnation and spleen-deficiency type. The efficacy of Comparative Example 1 was affected by changes in the drugs used; the efficacy of the herbal preparation in Comparative Example 2 decreased due to the omission of the components of *Codonopsis pilosula* and *Ficus hirta*.

[0101] Experimental Example 2: The therapeutic effect of the traditional Chinese medicine composition on functional dyspepsia

[0102] 1. Clinical subjects: 172 patients with functional dyspepsia of the liver-stagnation and spleen-deficiency type were included in this study. They were randomly divided into a control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group, with 43 patients in each group. There were no significant differences among the groups in terms of age, gender, and disease duration.

[0103] The control group received routine Western medicine treatment: domperidone tablets, 10 mg orally 30 minutes before meals, three times a day. The other three groups were treated with the drug components of Example 1, Comparative Example 1, and Comparative Example 2, respectively (Chinese herbal decoction, orally, one dose per day, divided into two warm doses, approximately 200-300 mL each time). Each group received treatment for 4 weeks as one course, for a total of one course of treatment.

[0104] 2. Diagnostic criteria:

[0105] Western medicine diagnostic criteria: Refer to the "Chinese Expert Consensus on Functional Dyspepsia (2015, Shanghai)" and the Rome IV diagnostic criteria.

[0106] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria in the "Expert Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Traditional Chinese Medicine (2017)".

[0107] 3. Efficacy evaluation criteria:

[0108] The clinical syndrome efficacy evaluation form for patients with functional dyspepsia in this trial was developed with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". The efficacy was evaluated based on the sum of the scores for patients' clinical symptoms and signs according to the clinical syndrome efficacy evaluation form, and the percentage improvement was assessed using the following formula:

[0109] Therapeutic efficacy index (total effective rate) = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%

[0110] Therapeutic effect evaluation: (1) Clinical cure: TCM clinical symptoms and signs disappear or basically disappear, efficacy index ≥ 95%; (2) Significant effect: TCM clinical symptoms and signs are significantly improved, 70% ≤ efficacy index < 95%; (3) Effective: TCM clinical symptoms and signs are all improved, 30% ≤ efficacy index < 70%; (4) Ineffective: TCM clinical symptoms and signs are not significantly improved, or even aggravated, efficacy index < 30%.

[0111] Overall efficacy (total effective rate) = (total number of cases - number of ineffective cases) / total number of cases × 100%.

[0112] 4. Treatment results:

[0113] After the treatment course, in Example 1 group, 20 cases were cured, 17 cases showed significant improvement, 3 cases were effective, and 3 cases were ineffective, with a total effective rate of 93.02%; in Comparative Example 1 group, 13 cases were cured, 9 cases showed significant improvement, 14 cases were effective, and 7 cases were ineffective, with a total effective rate of 83.72%; in Comparative Example 2 group, 6 cases were cured, 7 cases showed significant improvement, 21 cases were effective, and 9 cases were ineffective, with a total effective rate of 79.07%; in the control group, 2 cases were cured, 4 cases showed significant improvement, 27 cases were effective, and 10 cases were ineffective, with a total effective rate of 76.74%. Furthermore, no adverse reactions were observed in patients treated with the herbal composition of this invention after the treatment course. The above results show that the total effective rate of Example 1 group was higher than that of other groups after treatment, indicating that the herbal preparation prepared using the raw materials and preparation method of this invention has a better effect on treating functional dyspepsia of the liver-stagnation and spleen-deficiency type. The efficacy of Comparative Example 1 was affected by changes in the drugs used; the efficacy of the herbal preparation in Comparative Example 2 decreased due to the omission of the components *Codonopsis pilosula* and *Ficus hirta*.

[0114] The therapeutic effect of the composition in Experiment 3 on gastrointestinal neurosis

[0115] 1. Clinical subjects: 156 patients with gastrointestinal neurosis of the liver-stagnation and spleen-deficiency type were included in this study. They were randomly divided into a control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group, with 39 patients in each group. There were no significant differences among the groups in terms of age, gender, and disease duration.

[0116] The control group received routine Western medicine treatment, and for those with severe anxiety and depression, appropriate psychological counseling was provided. The medication regimen was as follows: (1) For those with indigestion, domperidone tablets were administered orally 30 minutes before meals, 10 mg each time, 3 times a day; omeprazole enteric-coated capsules were administered orally before meals, 20 mg each time, 2 times a day. (2) For those with irritable bowel syndrome, Bifidobacterium triple live bacteria capsules were administered orally after meals, 420 mg each time, 3 times a day. The dosage could be doubled for severe cases. The other three groups were treated with the drug components of Example 1, Comparative Example 1, and Comparative Example 2, respectively (Chinese herbal decoction, oral administration, one dose per day, divided into two warm doses in the morning and evening, about 200-300 mL each time). Each group was treated for 4 weeks as one course of treatment, for a total of 1 course of treatment.

[0117] 2. Diagnostic criteria:

[0118] Western medicine diagnostic criteria: Refer to "Gastroenterology" and the Rome IV diagnostic criteria.

[0119] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine".

[0120] 3. Efficacy evaluation criteria:

[0121] The clinical syndrome efficacy evaluation form for patients with gastrointestinal neurosis in this trial was developed with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". The total score of patients' clinical symptoms and signs was calculated based on the clinical syndrome efficacy evaluation form, and the percentage improvement was evaluated using the following formula:

[0122] Therapeutic efficacy index (total effective rate) = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%

[0123] Therapeutic effect evaluation: (1) Clinical cure: TCM clinical symptoms and signs disappear or basically disappear, efficacy index ≥ 95%; (2) Significant effect: TCM clinical symptoms and signs are significantly improved, 70% ≤ efficacy index < 95%; (3) Effective: TCM clinical symptoms and signs are all improved, 30% ≤ efficacy index < 70%; (4) Ineffective: TCM clinical symptoms and signs are not significantly improved, or even aggravated, efficacy index < 30%.

[0124] Overall efficacy (total effective rate) = (total number of cases - number of ineffective cases) / total number of cases × 100%.

[0125] 4. Treatment results:

[0126] After the treatment course, in Example 1 group, 10 cases were cured, 23 cases showed significant improvement, 4 cases were effective, and 2 cases were ineffective, with a total effective rate of 94.87%; in Comparative Example 1 group, 5 cases were cured, 14 cases showed significant improvement, 13 cases were effective, and 7 cases were ineffective, with a total effective rate of 82.05%; in Comparative Example 2 group, 3 cases were cured, 8 cases showed significant improvement, 19 cases were effective, and 9 cases were ineffective, with a total effective rate of 76.92%; in the control group, 1 case was cured, 4 cases showed significant improvement, 24 cases were effective, and 10 cases were ineffective, with a total effective rate of 74.36%. Furthermore, no adverse reactions were observed in patients treated with the herbal composition of this invention after the treatment course. The above results show that the total effective rate of Example 1 group was higher than that of other groups after treatment, indicating that the herbal preparation prepared using the raw materials and preparation method of this invention has a better effect on treating gastrointestinal neurosis of the liver-stagnation and spleen-deficiency type. The efficacy of Comparative Example 1 was affected by changes in the drugs used; the efficacy of the herbal preparation in Comparative Example 2 decreased due to the omission of the components *Codonopsis pilosula* and *Ficus hirta*.

[0127] The above embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the above embodiments. Any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention shall be considered equivalent substitutions and shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating distention, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Radix Bupleuri 3-10 parts, Radix Paeoniae Alba 6-15 parts, Plumeria rubra L. 5-10 parts, Radix Curcumae 5-12 parts, Radix Pseudostellariae 9-30 parts, Ficus tikus 15-30 parts, Poria cocos 9-15 parts, Albizia julibrissin Durazz 6-15 parts, Citrus grandis 3-6 parts, Drynaria fortunei 6-15 parts, Dalbergia hupeana 2-5 parts, Potentilla discolor 9-15 parts, Amomum villosum 3-6 parts, Fructus Amomi Rotundus 3-6 parts, Perilla frutescens 5-10 parts, Pericarpium Arecae 5-10 parts, Rhizoma Phragmitis 15-30 parts, Bamboo Shavings 5-10 parts, Juncus 5-25 parts, Fried rice sprout 9-15 parts, Herba Polygoni Avicularis 9-15 parts, Herba Brevispicati 15-30 parts, Radix Salviae Miltiorrhizae 6-15 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Radix Bupleuri 5-10 parts, Radix Paeoniae Alba 9-15 parts, Plumeria rubra L. 6-10 parts, Radix Curcumae 6-12 parts, Radix Pseudostellariae 10-30 parts, Ficus tikus 20-30 parts, Poria cocos 9-12 parts, Albizia julibrissin Durazz 6-12 parts, Citrus grandis 4-6 parts, Drynaria fortunei 9-15 parts, Dalbergia hupeana 3-5 parts, Potentilla discolor 9-12 parts, Amomum villosum 4-6 parts, Fructus Amomi Rotundus 4-6 parts, Perilla frutescens 6-10 parts, Pericarpium Arecae 6-10 parts, Rhizoma Phragmitis 15-20 parts, Bamboo Shavings 6-10 parts, Juncus 6-25 parts, Fried rice sprout 9-12 parts, Herba Polygoni Avicularis 9-12 parts, Herba Brevispicati 15-25 parts, Radix Salviae Miltiorrhizae 6-12 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Radix Bupleuri 6-10 parts, Radix Paeoniae Alba 12-15 parts, Plumeria rubra L. 6-9 parts, Radix Curcumae 6-9 parts, Radix Pseudostellariae 10-20 parts, Ficus tikus 25-30 parts, Poria cocos 9-10 parts, Albizia julibrissin Durazz 6-10 parts, Citrus grandis 4-5 parts, Drynaria fortunei 10-15 parts, Dalbergia hupeana 3-4 parts, Potentilla discolor 9-10 parts, Amomum villosum 5-6 parts, Fructus Amomi Rotundus 5-6 parts, Perilla frutescens 6-9 parts, Pericarpium Arecae 9-10 parts, Rhizoma Phragmitis 15-20 parts, Bamboo Shavings 9-10 parts, Juncus 6-15 parts, Fried rice sprout 9-10 parts, Herba Polygoni Avicularis 9-10 parts, Herba Brevispicati 15-20 parts, Radix Salviae Miltiorrhizae 6-10 parts.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Radix Bupleuri 9 parts, Radix Paeoniae Alba 15 parts, Plumeria rubra L. 6 parts, Radix Curcumae 6 parts, Radix Pseudostellariae 15 parts, Ficus tikus 30 parts, Poria cocos 10 parts, Albizia julibrissin Durazz 9 parts, Citrus grandis 5 parts, Drynaria fortunei 12 parts, Dalbergia hupeana 3 parts, Potentilla discolor 10 parts, Amomum villosum 6 parts, Fructus Amomi Rotundus 6 parts, Perilla frutescens 6 parts, Pericarpium Arecae 10 parts, Rhizoma Phragmitis 15 parts, Bamboo Shavings 9 parts, Juncus 10 parts, Fried rice sprout 10 parts, Herba Polygoni Avicularis 10 parts, Herba Brevispicati 20 parts, Radix Salviae Miltiorrhizae 10 parts.

5. A traditional Chinese medicine oral preparation for treating pimel, characterized in that, The traditional Chinese medicine composition comprises any one of claims 1-4.

6. The oral formulation according to claim 5, wherein The oral preparation is a decoction, granules, capsules, tablets, pills or oral liquid.

7. Use of the traditional Chinese medicine composition of any one of claims 1-4 or the traditional Chinese medicine oral preparation of claim 5 or 6 in the preparation of a drug for treating liver stagnation and spleen deficiency type distention.

8. Use according to claim 7, characterized in that, The liver stagnation and spleen deficiency type distention is chronic gastritis.

9. Use according to claim 7, characterized in that, The liver stagnation and spleen deficiency type distention is functional dyspepsia.

10. Use according to claim 7, characterized in that, The liver stagnation and spleen deficiency type distention is gastrointestinal neurosis.