A traditional Chinese medicine composition for treating diarrhea of spleen deficiency and dampness-heat type and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition for treating diarrhea caused by spleen deficiency and damp-heat, and its application. The raw materials of the traditional Chinese medicine composition of this invention include five-finger peach, codonopsis, Chinese yam, white cardamom, agastache, light bamboo leaf, plantain, broom leaf, firethorn, kapok flower, frangipani, tangerine peel, citronella, bergamot, clematis, roasted rice sprouts, roasted radish seeds, euryale seed, schisandra fruit, pomegranate peel, and prepared licorice root. All are inexpensive and readily available traditional Chinese medicinal materials, natural and safe, with no toxic side effects. The traditional Chinese medicine composition of this invention is formulated under the guidance of classical traditional Chinese medicine theory, with a scientific and rational combination. The combined effects of these herbs are to invigorate the spleen and replenish qi, clear heat and remove dampness, astringe the intestines and stop diarrhea. It treats the root cause of the disease, addressing both the symptoms and the underlying cause, and has a unique therapeutic effect on diarrhea caused by spleen deficiency and damp-heat (especially diarrhea-predominant irritable bowel syndrome, chronic enteritis, and functional diarrhea), with no obvious adverse reactions observed, showing good application prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology. More specifically, it relates to a traditional Chinese medicine composition for treating diarrhea of ​​spleen deficiency and damp-heat type and its application. Background Technology

[0002] Diarrhea is a disease characterized by increased frequency of bowel movements, loose stools, or even watery stools. It is often accompanied by abdominal discomfort, bloating, abdominal pain, borborygmus, poor appetite, and difficulty urinating. In ancient times, loose stools with a slow, gradual onset were called "xie," while watery stools with a rapid onset were called "xie." Now, both are collectively referred to as diarrhea. Traditional Chinese medicine believes that diarrhea is often caused by external pathogens, improper diet, emotional imbalance, weakness of the internal organs, or congenital deficiencies. The *Jingyue Quanshu* (Complete Works of Jingyue) states in its section on diarrhea: "The root of diarrhea is invariably the spleen and stomach." The spleen is the root of diarrhea, and its location is in the spleen, stomach, and large and small intestines, closely related to the liver and kidneys. The *Suwen* (Plain Questions) records: "Those with spleen disease, when deficient, experience abdominal fullness, borborygmus, diarrhea, and indigestion." Weakness of the spleen and stomach is the main pathogenesis of diarrhea, and the main pathogenic factor is dampness, as described in the *Nanjing* (Classic of Difficult Issues): "Excessive dampness leads to five types of diarrhea," and there is also the saying, "When dampness prevails, there is watery diarrhea," and "Diarrhea is inseparable from dampness."

[0003] The spleen and stomach are the foundation of postnatal health, internally and externally related. They are responsible for receiving and transforming food and water, their essence permeating all organs, generating qi, blood, and defensive qi, thus being called the "source of qi and blood" in the human body. The spleen governs transformation and transportation, producing the essence of food and water, preferring dryness and disliking dampness, and its health depends on the ascending of clear qi. The stomach, on the other hand, receives and digests food and water, preferring moisture and disliking dryness, and its function depends on the descending of clear qi. Their ascending and descending functions maintain the harmonious balance of qi in the body. Dampness is a yin evil, primarily damaging the spleen and stomach. When dampness impairs the spleen, its function of transportation and transportation is disrupted, leading to impaired spleen and stomach function in receiving, transforming, ascending, and descending. Clear qi fails to ascend, food and water are not transformed, the small intestine cannot separate clear from turbid, and the large intestine's transformation and transportation become abnormal. Water becomes dampness, and food becomes stagnant. The essence of qi cannot be transported and transformed, mixing and descending directly to the intestines, resulting in diarrhea. Dampness is sticky and heavy, and easily combines with heat evil to invade the spleen and stomach, obstructing the middle jiao, forcing down to the large intestine and causing diarrhea.

[0004] Prolonged diarrhea can easily shift from an excess to a deficiency pattern, often presenting as a mixed deficiency and excess. Clinically, spleen deficiency with damp-heat type diarrhea is more common, which is closely related to changes in people's lifestyles. Modern life is fast-paced, with long-term mental stress, anxiety, and overwork, which damages the spleen and stomach over time. A diet high in spicy, rich, and greasy foods, along with excessive alcohol consumption, easily leads to the accumulation of heat in the spleen, stomach, and intestines. This disrupts the separation of clear and turbid substances in the intestines, causing dysfunction in digestion and transformation, resulting in "spleen deficiency with damp-heat type diarrhea." This syndrome is rooted in spleen deficiency, with damp-heat as the manifestation. Weakness of the spleen and stomach, and impaired digestion, often presents with symptoms such as poor appetite, abdominal distension, fatigue, and pale complexion. Damp-heat accumulation and stagnation of Qi often present with symptoms such as abdominal pain, sticky stools, scanty dark urine, and dry mouth and thirst. Modern medicine categorizes gastrointestinal diseases such as irritable bowel syndrome, chronic enteritis, and functional diarrhea as "diarrhea" based on clinical symptoms, with the spleen deficiency with damp-heat type increasingly prevalent.

[0005] Diarrhea-predominant irritable bowel syndrome (IBS) is a persistent or intermittent functional bowel disorder characterized by abdominal pain, bloating, changes in bowel habits and / or stool consistency. The overall prevalence of IBS in the general population of my country is 1.4%–1.5%, with a slightly higher prevalence in women than men. It occurs in all age groups, but is more common in young adults aged 18–59. It shows a familial clustering tendency and often coexists with other gastrointestinal functional disorders such as functional dyspepsia.

[0006] Chronic enteritis refers to a chronic inflammatory disease of the intestines. It is a common and stubborn disease in clinical practice. The causes can be infections by microorganisms such as bacteria, fungi, viruses, and protozoa, as well as allergies and hypersensitivity reactions. Clinical manifestations include long-term chronic or recurrent abdominal pain, diarrhea, and indigestion. In severe cases, there may be mucus or watery stools. The condition is recurrent, with varying degrees of severity, and is difficult to cure. The course of the disease is relatively long, and the incidence rate is showing an increasing trend year by year.

[0007] Functional diarrhea (FPD) is a syndrome characterized by persistent or recurrent loose or watery stools without abdominal pain or discomfort. It is a common functional gastrointestinal disorder, and its pathological mechanism is currently unclear. However, abnormal gastrointestinal motility, visceral hypersensitivity, intestinal microecological dysbiosis, abnormal gastrointestinal hormone secretion, and psychological factors can all contribute to its development. FPD is characterized by its chronic, recurrent, and refractory nature. Epidemiological surveys show that its incidence is continuously increasing, with a significantly higher incidence in the Chinese population compared to other parts of Asia.

[0008] Modern medicine lacks specific drugs for treating diarrhea, and treatment is mostly symptomatic. Clinically, antidiarrheal drugs, antispasmodics, and antibiotics are commonly used to relieve diarrhea; probiotics can relieve abdominal pain and bloating; psychotropic drugs can be used to treat anxiety and depression, and fluid and electrolyte supplements can be replenished (Zhou Ronghua, Chen Yibin. Research progress in the treatment of diarrhea-predominant irritable bowel syndrome with traditional Chinese and Western medicine [J]. China Medical Guide, 2022, 24(11):1119-1122; Tian Di, Wang Chuijie. Research progress in the treatment of functional diarrhea with traditional Chinese and Western medicine [J]. Journal of Liaoning University of Traditional Chinese Medicine, 2019, 21(11):222-224.). These methods often ignore the root cause, treat the symptoms but not the root cause, and the treatment effect is not obvious and the treatment result is incomplete; leading to repeated attacks of the disease and obvious side effects. For example, antidiarrheal drugs may cause nausea and vomiting; antispasmodics may cause palpitations and hypotension; long-term use of antibiotics may lead to intestinal flora imbalance; psychotropic drugs have dependence and addiction, etc. Prolonged diarrhea can lead to dehydration, electrolyte imbalance, malnutrition, and other symptoms, negatively impacting daily life and work and severely reducing quality of life. Summary of the Invention

[0009] The technical problem to be solved by the present invention is to overcome the defects and shortcomings of existing antidiarrheal drugs, which often ignore the root cause, treat the symptoms but not the root cause, have little therapeutic effect and obvious side effects. The present invention provides a traditional Chinese medicine composition for treating diarrhea of ​​spleen deficiency and damp-heat type. The traditional Chinese medicine composition has the effects of strengthening the spleen and replenishing qi, clearing heat and removing dampness and astringing the intestines to stop diarrhea. It is particularly effective in treating diarrhea-predominant irritable bowel syndrome, chronic enteritis and functional diarrhea.

[0010] The purpose of this invention is to provide an oral preparation of a traditional Chinese medicine composition.

[0011] The purpose of this invention is to provide an application of a traditional Chinese medicine composition in the preparation of a drug with the effects of invigorating the spleen and replenishing qi, clearing heat and removing dampness.

[0012] Another objective of this invention is to provide the application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating diarrhea caused by spleen deficiency and damp-heat.

[0013] The above-mentioned objective of this invention is achieved through the following technical solution:

[0014] Diarrhea due to spleen deficiency and damp-heat is characterized by spleen deficiency as the root cause and damp-heat as the manifestation. The condition is complex, has a long course, and is prone to recurrence. Therefore, the key pathological mechanism of spleen deficiency and damp-heat should be grasped in the treatment. The treatment should focus on strengthening the spleen and replenishing qi, clearing heat and removing dampness, and should follow the nature of the spleen and stomach, nourishing and tonifying slowly, and strengthening the earth to control water. The medicine for removing damp-heat should not be too strong, so as not to damage the stomach yin.

[0015] Based on this, the present invention proposes a traditional Chinese medicine composition for treating diarrhea of ​​spleen deficiency and damp-heat type, comprising the following raw materials in parts by weight: 20-30 parts of *Ficus hirta*, 15-30 parts of *Codonopsis pilosula*, 15-30 parts of *Dioscorea opposita*, 5-10 parts of *Amomum villosum*, 5-10 parts of *Eupatorium fortunei*, 6-10 parts of *Lophatherum gracile*, 9-20 parts of *Plantago asiatica*, 15-30 parts of *Clerodendrum trichotomum*, 9-15 parts of *Polygonum cuspidatum*, 6-9 parts of *Bombax ceiba*, 5-9 parts of *Frangipani*, 3-6 parts of *Citrus reticulata*, 5-10 parts of *Citrus medica*, 9-30 parts of *Impatiens balsamina*, 10-15 parts of stir-fried rice sprouts, 5-10 parts of stir-fried radish seeds, 9-15 parts of *Euryale ferox*, 2-6 parts of *Schisandra chinensis*, 3-9 parts of pomegranate peel, and 3-10 parts of prepared licorice root.

[0016] Explanation of the formula of the traditional Chinese medicine composition of this invention:

[0017] Diarrhea due to spleen deficiency and damp-heat is caused by spleen deficiency as the root cause, with damp-heat as the superficial manifestation accompanied by fluid depletion. In this formula, *Ficus hirta*, produced in Lingnan, can both tonify the spleen and replenish qi, and also promote qi circulation and eliminate dampness. Its nature is neither warm nor dry; it tonifies qi without generating fire, and is known as "Southern Astragalus." *Codonopsis pilosula* tonifies qi and generates fluids without promoting dampness, supports the body's resistance without retaining pathogenic factors, and tonifies deficiency without being drastic. *Dioscorea opposita* tonifies both yin and yang, and is an essential medicine for strengthening the spleen and stomach, effectively stopping diarrhea. These three herbs strengthen the spleen and stomach, nourish the body's resistance, and strengthen the earth element to control water, serving as the principal herbs. Their effects are mild and gentle, without the risk of generating heat and damaging fluids, nor causing qi stagnation. "The earth is warm and loves fragrance," so white cardamom and agastache are used to dispel dampness and promote qi circulation, invigorate the spleen and stomach, and regulate the middle jiao, enhancing the spleen and stomach's digestive function. This further assists the principal herbs in enhancing the spleen-strengthening and qi-tonifying effects. Lophatherum gracile and plantain are mildly diuretic and promote diuresis, allowing water to flow downwards and clear the urinary tract, thus "promoting urination and solidifying stool." Buzha leaf and charcoal bud are mild in nature and excel at clearing damp-heat from the spleen and stomach. Buzha leaf can also aid digestion and eliminate food stagnation, while charcoal bud has a slightly sour taste, clearing heat without harming yin. Adding kapok flower and frangipani flower enhances the heat-clearing and dampness-draining effects. These eight herbs together serve as assistant herbs, removing damp-heat without the harmful effects of bitterness and coldness on the stomach. When the spleen is weak and unable to function properly, damp-heat obstructs the qi mechanism of the middle jiao, common symptoms include abdominal distension, abdominal pain, borborygmus, poor appetite, and loss of appetite. The formula uses Citrus reticulata peel, Citrus medica var. sarcodactylis, and Citrus medica var. sarcodactylis to invigorate the spleen, dry dampness, regulate qi, relieve pain, and promote the circulation of qi in the middle jiao. It is supplemented with stir-fried rice sprouts and stir-fried radish seeds to harmonize the middle jiao, aid digestion, and invigorate the spleen and stomach. Since prolonged spleen deficiency can affect kidney yang, Euryale ferox, with its sweet and astringent taste, excels at tonifying the kidneys, securing essence, and stopping diarrhea. Pomegranate peel and Schisandra chinensis, with their sour and astringent tastes, are also used. Schisandra chinensis excels at tonifying the kidneys and securing essence, while pomegranate peel excels at astringing the intestines and stopping diarrhea. The three herbs used together achieve the effects of tonifying the spleen and kidneys, astringing the intestines, and stopping diarrhea. These eight herbs are used as adjuvant herbs. Prepared licorice root invigorates the spleen, harmonizes the middle jiao, relieves spasms and pain, and harmonizes the effects of the other herbs, serving as the guiding herb. Overall, the formula combines spleen-invigorating and damp-heat-clearing herbs, addressing both the root cause and the symptoms. It tonifies while purging, supporting the body's resistance without retaining pathogens; it clears while astringing, expelling pathogens without harming the body's resistance. Furthermore, it is supplemented with qi-regulating and digestion-aiding herbs to further benefit the spleen and stomach. Together, these herbs tonify the spleen and qi, clear heat and dampness, and astringe the intestines to stop diarrhea.

[0018] The medicinal properties of the traditional Chinese medicine used in this invention are as follows:

[0019] Five-finger peach: Sweet in taste and neutral in nature. It enters the spleen, lung, and liver meridians. It has the effects of strengthening the spleen and lungs, promoting qi circulation and removing dampness, and relaxing muscles and tendons. It is mainly used to treat spleen deficiency edema, poor appetite and weakness, pulmonary tuberculosis cough, night sweats, leukorrhea, postpartum agalactia, rheumatic pain, edema, ascites due to cirrhosis, hepatitis, and traumatic injuries. Modern research has found that five-finger peach has multiple pharmacological effects, including antibacterial, immune-enhancing, expectorant, antioxidant, anti-inflammatory and analgesic, and smooth muscle relaxant effects.

[0020] Codonopsis pilosula: Sweet and slightly bitter in taste, neutral in nature. It enters the spleen and lung meridians. It invigorates qi and strengthens the spleen, generates fluids and moistens the lungs. It is used for spleen deficiency with fatigue, loss of appetite, post-illness weakness, qi and yin deficiency, spontaneous sweating with thirst, and dry cough due to lung dryness. Modern research has found that Codonopsis pilosula has multiple pharmacological effects, including enhancing immune function, improving memory, anti-stress, anti-fatigue, improving small intestine absorption, lowering blood sugar, lowering blood lipids, antibacterial, antitussive, antiviral, and anti-inflammatory properties.

[0021] Chinese yam: Sweet in taste, neutral in property. It acts on the lung, spleen, kidney, and stomach meridians. It invigorates the spleen and nourishes the stomach, promotes the production of fluid and benefits the lung, tonifies the kidney and arrests seminal emission. It is used for diarrhea due to spleen deficiency, chronic dysentery, consumptive cough, spermatorrhea and leukorrhagia, frequent urination, diabetes, uterine prolapse. Modern research has found that Chinese yam has multiple pharmacological effects such as lowering blood sugar, reducing blood lipid, anti-tumor and anti-mutation.

[0022] Amomum kravanh: Pungent in taste, warm in property. It acts on the lung, spleen, and stomach meridians, resolves dampness and promotes qi movement; warms the middle-jiao and stops vomiting; promotes appetite and aids digestion. It is mainly used for damp obstruction and qi stagnation; disharmony between the spleen and stomach; abdominal distension and fullness; loss of appetite; the initial stage of damp-warm syndrome; chest distress and lack of hunger; vomiting due to stomach cold; indigestion. Modern research has found that Amomum kravanh has multiple pharmacological effects such as protecting the gastrointestinal tract, antioxidant, lowering blood sugar, sedative hypnotic and antibacterial anti-inflammatory.

[0023] Eupatorium fortunei: Pungent in taste, neutral in property. It acts on the spleen, stomach, and lung meridians. It aromatically resolves dampness, awakens the spleen and promotes appetite, induces sweating and relieves summer heat. It is used for damp turbidity obstructing the middle-jiao, fullness and vomiting in the epigastrium, sweet taste in the mouth, bad breath, excessive salivation, summer dampness exterior syndrome, the initial stage of damp-warm syndrome, fever and lassitude, chest distress and discomfort. Modern research has found that Eupatorium fortunei has multiple pharmacological effects such as anti-inflammatory, anti-tumor, enhancing immunity, bacteriostasis and exciting gastric smooth muscle.

[0024] Lophatherum gracile: Sweet and bland in taste, cold in property. It acts on the heart, stomach, and small intestine meridians. It clears heat and purges fire, relieves restlessness and quenches thirst, promotes diuresis and discharges dampness. It is used for restlessness and thirst due to febrile disease, short and red painful urination, aphtha of the mouth and tongue. Modern research has found that Lophatherum gracile has multiple pharmacological effects such as bacteriostasis, antioxidant, protecting the liver, constricting blood vessels, antiviral, reducing blood lipid and protecting the myocardium.

[0025] Plantago asiatica: Sweet in taste, cold in property. It acts on the liver, kidney, lung, and small intestine meridians. It clears heat, promotes diuresis and discharges dampness, reduces phlegm, cools the blood, and detoxifies. It is used for painful and difficult urination due to heat strangury, edema with scanty urine, diarrhea due to summer dampness, cough due to phlegm-heat, spitting blood and nosebleed, carbuncles and sores. Modern research has found that Plantago asiatica has multiple pharmacological effects such as antibacterial anti-inflammatory, antiviral, antioxidant, enhancing immunity, lowering blood sugar, reducing blood lipid, reducing blood uric acid and antidepressant.

[0026] Microcos paniculata: Slightly sour in taste, cool in property. It acts on the spleen and stomach meridians. It promotes digestion and removes stagnation, clears heat and promotes diuresis. It is used for food retention, common cold with fever, jaundice due to damp-heat. Modern research has found that Microcos paniculata has multiple pharmacological effects such as reducing blood lipid, antipyretic, analgesic, anti-inflammatory, regulating gastric juice secretion and protecting the myocardium.

[0027] Polygonum chinense: Slightly sour and astringent in taste, cool in property; it acts on the liver and spleen meridians. It has the effects of clearing heat and promoting diuresis, cooling the blood and detoxifying, soothing the liver and improving eyesight, activating blood circulation and relaxing tendons. It is used for dysentery, diarrhea, sore throat, diphtheria, cough due to lung heat, pertussis, hepatitis, leukorrhagia, cancer, otitis media, eczema, dizziness and tinnitus, corneal nebula, traumatic injury. "Common Handbook of Chinese Herbal Medicines" records: "Clearing and promoting dampness, eliminating stagnation and detoxifying, treating dysentery, enteritis, and indigestion." Modern research has found that Polygonum chinense has multiple pharmacological effects such as antioxidant, anti-pathogenic microorganism, anti-inflammatory, analgesic, anti-diarrhea and anti-hepatocarcinoma.

[0028] Kapok flower: Sweet and light in flavor, cool in nature. It pertains to the large intestine meridian. It clears heat and promotes diuresis, and detoxifies. It is used for diarrhea, dysentery, and hemorrhoids bleeding. Modern research has found that kapok flower has multiple pharmacological effects such as anti-inflammatory, antibacterial, anti-tumor, antioxidant, hypoglycemic, and liver protection.

[0029] Plumeria rubra 'Acutifolia': Sweet and slightly bitter in flavor, cool in nature. It pertains to the lung and large intestine meridians. It clears heat and relieves summer heat, promotes diuresis, relieves cough, and prevents heatstroke. It is used for diarrhea, bacillary dysentery, indigestion, infantile malnutrition, infectious hepatitis, and bronchitis. Modern research has found that plumeria rubra 'Acutifolia' has multiple pharmacological effects such as antipyretic analgesia, antitussive, expectorant, free radical scavenging, bacteriostatic, anti-tumor, antioxidant, and lipid-lowering.

[0030] Exocarpium Citri Grandis: Pungent and bitter in flavor, warm in nature. It pertains to the lung and spleen meridians. It regulates qi and relieves fullness, dries dampness and resolves phlegm. It is used for cough with profuse phlegm, food retention due to excessive drinking, nausea and stuffiness. Modern research has found that exocarpium citri grandis has multiple pharmacological effects such as resolving phlegm and relieving cough, anti-inflammatory, antioxidant, immune regulation, and myocardial protection.

[0031] Buddha's hand: Pungent, bitter, and sour in flavor, warm in nature. It pertains to the liver, spleen, stomach, and lung meridians. It soothes the liver and regulates qi, harmonizes the stomach and relieves pain, dries dampness and resolves phlegm. It is used for liver-stomach qi stagnation, chest and hypochondriac pain, gastric fullness and stuffiness, anorexia and vomiting, cough with profuse phlegm. Guangfo's hand is a plant of the genus Citrus in the Rutaceae family, mainly produced in Lecheng Town, Gaoyao, Wulong, Deqing, Yunfu, Yunan and other places. It has a long cultivation history and is one of the "Ten Famous Guangdong Medicines", the local authentic medicinal materials in Guangdong. Modern research has found that Buddha's hand has multiple pharmacological effects such as antioxidant, antibacterial, anti-inflammatory, anti-tumor, hypoglycemic, lipid-lowering, immune regulation, and anti-aging.

[0032] Ilex rotunda: Bitter in flavor, cold in nature. It pertains to the lung, stomach, large intestine, and liver meridians. It clears heat and detoxifies, promotes diuresis and relieves pain. It is used for summer dampness fever, sore throat, damp-heat diarrhea, abdominal distension pain, rheumatic arthralgia, eczema, furuncle, and traumatic injury. Modern research has found that Ilex rotunda has multiple pharmacological effects such as bacteriostatic, analgesic and anti-inflammatory, cardiovascular protection, liver protection, and anti-tumor.

[0033] Fructus Germinatus Oryzae: Sweet in flavor, warm in nature. It pertains to the spleen and stomach meridians. It promotes digestion and regulates the middle, strengthens the spleen and promotes appetite. It is used for food retention, abdominal distension and bad breath, spleen and stomach weakness, anorexia. Stir-fried Fructus Germinatus Oryzae is prepared by stir-frying Fructus Germinatus Oryzae with gentle fire, and its effect of promoting digestion and strengthening the spleen is slightly stronger. Modern research has found that Fructus Germinatus Oryzae has multiple pharmacological effects such as promoting digestion, reducing blood pressure, and reducing blood lipid.

[0034] Semen Raphani: Pungent and sweet in flavor, neutral in nature. It pertains to the lung, spleen, and stomach meridians. It promotes digestion and relieves distension, descends qi and resolves phlegm. It is used for food stagnation, abdominal distension pain, constipation, diarrhea due to food retention, cough with phlegm congestion. Stir-fried Semen Raphani is Semen Raphani stir-fried according to the method of stir-frying (General Rules 0213) until slightly bulged. Modern research has found that Semen Raphani has multiple pharmacological effects such as antiasthmatic, antitussive, expectorant, antioxidant, blood pressure reduction, lipid-lowering, antibacterial, and enhancing gastrointestinal motility.

[0035] Gorgon Fruit: Sweet, astringent, with a neutral nature. It acts on the spleen and kidney meridians. It benefits the kidney and consolidates essence, strengthens the spleen and stops diarrhea, eliminates dampness and stops leukorrhea. It is used for spermatorrhea and emission, enuresis and frequent urination, chronic diarrhea due to spleen deficiency, leukorrhea with turbid discharge, and vaginal discharge. "Seeking Truth from Herbs" records: "How does gorgon fruit strengthen the spleen? Because of its sweet taste; how does gorgon fruit consolidate the kidney? Because of its astringent taste. Only because of its sweet taste for strengthening the spleen, it can promote diuresis and treat diarrhea and abdominal pain; only because of its astringent taste for consolidating the kidney, it can close qi and cure spermatorrhea, leukorrhea, and incontinence of urine." Modern pharmacological research has found that gorgon fruit has effects such as antioxidant, antibacterial, anti-tumor, hypoglycemic, and lipid-lowering.

[0036] Schisandra chinensis: Sour, sweet, with a warm nature. It acts on the lung, heart, and kidney meridians. It has the functions of astringing and consolidating, replenishing qi and promoting fluid production, tonifying the kidney and calming the mind. It is used for chronic cough and dyspnea, spermatorrhea and emission, enuresis and frequent urination, chronic diarrhea, spontaneous sweating and night sweating, thirst due to fluid consumption, internal heat and polydipsia, palpitation and insomnia. Modern research has found that Schisandra chinensis has multiple pharmacological effects such as sedative and hypnotic, antioxidant, antidepressant, anti-fatigue, immune regulation, hypoglycemic, lipid-lowering, protecting the cardiovascular system, and protecting neurons.

[0037] Pomegranate Peel: Sour, astringent, with a warm nature. It acts on the large intestine meridian. It has the functions of astringing the intestine and stopping diarrhea, stopping bleeding, and expelling worms. It is used for chronic diarrhea, dysentery, hematochezia, rectal prolapse, metrorrhagia and metrostaxis, vaginal discharge, and abdominal pain due to worm accumulation. Modern research has found that pomegranate peel has multiple pharmacological effects such as anti-tumor, antibacterial, antiviral, protecting the liver, and lipid-lowering.

[0038] Licorice Root: Sweet, with a neutral nature. It acts on the heart, lung, spleen, and stomach meridians. It strengthens the spleen and replenishes qi, clears heat and detoxifies, reduces phlegm and relieves cough, alleviates spasm and pain, and harmonizes various medicinal herbs. It is used for spleen and stomach weakness, lassitude and weakness, palpitation and shortness of breath, cough with profuse phlegm, abdominal and limb spasm and pain, carbuncles and sores, and relieving drug toxicity. Prepared licorice root is licorice root baked with honey. Modern pharmacological research has found that licorice root has effects such as anti-inflammatory, anti-tumor, antibacterial, antiviral, antioxidant, and immune regulation.

[0039] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 21 - 25 parts of Ficus hirta, 15 - 20 parts of Pseudostellaria heterophylla, 16 - 20 parts of Dioscorea opposita, 6 - 8 parts of Amomum kravanh, 6 - 8 parts of Eupatorium fortunei, 6 - 8 parts of Lophatherum gracile, 10 - 15 parts of Plantago asiatica, 16 - 20 parts of Microcos paniculata, 10 - 15 parts of Polygonum chinense, 6 - 8 parts of Bombax ceiba, 6 - 8 parts of Plumeria rubra, 5 - 6 parts of Citrus grandis 'Tomentosa', 6 - 8 parts of Citrus medica var. sarcodactylis, 10 - 15 parts of Ilex rotunda, 10 - 12 parts of stir-fried Oryza sativa sprouts, 6 - 8 parts of stir-fried Semen raphani, 9 - 10 parts of gorgon fruit, 3 - 5 parts of Schisandra chinensis, 5 - 8 parts of pomegranate peel, 5 - 6 parts of prepared licorice root.

[0040] More preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 25 parts of *Ficus hirta*, 20 parts of *Codonopsis pilosula*, 20 parts of *Dioscorea opposita*, 8 parts of *Amomum villosum*, 8 parts of *Eupatorium fortunei*, 8 parts of *Lophatherum gracile*, 15 parts of *Plantago asiatica*, 20 parts of *Broussonetia papyrifera*, 15 parts of *Polygonum chinense*, 8 parts of *Bombax ceiba*, 8 parts of *Frangipani*, 6 parts of *Citrus reticulata*, 8 parts of *Citrus medica*, 15 parts of *Illicium verum*, 12 parts of stir-fried rice sprouts, 8 parts of stir-fried radish seeds, 10 parts of *Euryale ferox*, 5 parts of *Schisandra chinensis*, 8 parts of pomegranate peel, and 6 parts of prepared licorice root.

[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 Chinese medicine preparation is an oral preparation made by adding pharmaceutically acceptable excipients to a Chinese medicine composition and preparing it according to conventional processes.

[0043] Preferably, the oral preparation is a decoction, capsule, granule, tablet, pill, or oral liquid.

[0044] Preferably, the excipients are magnesium stearate, dextrin, sucrose, honey, refined honey, or sorbic acid.

[0045] Meanwhile, the present invention also protects the use of the aforementioned traditional Chinese medicine composition or oral preparation in the preparation of drugs with the effects of invigorating the spleen and replenishing qi, clearing heat and removing dampness.

[0046] In addition, the present invention protects the use of the traditional Chinese medicine composition or oral preparation of traditional Chinese medicine in the preparation of a drug for treating diarrhea caused by spleen deficiency and damp-heat; preferably, the diarrhea caused by spleen deficiency and damp-heat is diarrhea-predominant irritable bowel syndrome, chronic enteritis, or functional diarrhea.

[0047] The present invention has the following beneficial effects:

[0048] This invention provides a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat. The composition includes five-finger peach, codonopsis, Chinese yam, white cardamom, eupatorium, light bamboo leaf, plantain, *Broussonetia papyrifera* leaf, *Polygonum chinense*, kapok flower, frangipani flower, tangerine peel, citronella, *Citrus medica*, *Ligusticum striatum*, stir-fried rice sprouts, stir-fried radish seeds, euryale seed, schisandra fruit, pomegranate peel, and prepared licorice root. Through rational combination, this medicine conforms to the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine, synergistically tonifying the spleen and replenishing qi, clearing heat and removing dampness, and astringing the intestines to stop diarrhea. The medicinal materials selected in this invention are authentic and well-matched, complementing each other functionally. It is safe to take with no side effects and suitable for a wide range of people. Clinical results show that the weight ratio of the components in this invention is optimal, exhibiting significant therapeutic effects on diarrhea due to spleen deficiency and damp-heat, especially diarrhea-predominant irritable bowel syndrome, chronic enteritis, and functional diarrhea, with a total effective rate exceeding 93%. Detailed Implementation

[0049] 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.

[0050] Unless otherwise specified, all reagents and materials used in the following examples are commercially available.

[0051] Example 1: A decoction of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0052] Formula: 25g of Five-Finger Peach, 20g of Codonopsis pilosula, 20g of Chinese Dioscorea opposita, 8g of White Cardamom, 8g of Eupatorium fortunei, 8g of Lophatherum gracile, 15g of Plantago asiatica, 20g of Buzhaye, 15g of Polygonum cuspidatum, 8g of Bombax ceiba, 8g of Plumeria rubra, 6g of Citrus reticulata peel, 8g of Citrus medica var. sarcodactylis, 15g of Medicago sativa, 12g of stir-fried rice sprouts, 8g of stir-fried radish seeds, 10g of Euryale ferox, 5g of Schisandra chinensis, 8g of pomegranate peel, and 6g of prepared licorice root.

[0053] Preparation method: Select, wash and dry all the above-mentioned medicinal materials, weigh them according to the amount, add 6 to 10 times the amount of water to soak, first boil over high heat, then simmer over low heat for 30 to 60 minutes, filter and collect the filtrate; add 3 to 6 times the amount of water to the filter residue and repeat the above decoction and filtration steps, mix the two filtrates to obtain the one-day dose decoction of the Chinese medicine composition.

[0054] Example 2: A decoction of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0055] Formula: 20g of Five-Finger Peach, 15g of Codonopsis pilosula, 15g of Chinese Dioscorea opposita, 6g of White Cardamom, 6g of Eupatorium fortunei, 6g of Lophatherum gracile, 10g of Plantago asiatica, 15g of Buzhaye, 10g of Polygonum cuspidatum, 6g of Bombax ceiba, 6g of Plumeria rubra, 5g of Citrus reticulata peel, 5g of Citrus medica var. sarcodactylis, 10g of Rehmannia glutinosa sprouts, 10g of stir-fried rice sprouts, 5g of stir-fried radish seeds, 9g of Euryale ferox, 3g of Schisandra chinensis, 5g of pomegranate peel, and 5g of prepared licorice root.

[0056] Preparation method: Same as in Example 1.

[0057] Example 3: A decoction of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0058] Formula: 25g of Five-Finger Peach, 20g of Codonopsis pilosula, 15g of Chinese Dioscorea opposita, 8g of White Cardamom, 8g of Eupatorium fortunei, 8g of Lophatherum gracile, 12g of Plantago asiatica, 16g of Buzhaye, 12g of Polygonum cuspidatum, 8g of Bombax ceiba, 8g of Plumeria rubra, 5g of Citrus reticulata peel, 6g of Citrus medica, 12g of Rehmannia glutinosa sprouts, 12g of stir-fried rice sprouts, 6g of stir-fried radish seeds, 9g of Euryale ferox, 5g of Schisandra chinensis, 6g of pomegranate peel, and 5g of prepared licorice root.

[0059] Preparation method: Same as in Example 1.

[0060] Example 4: A capsule formulation of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0061] The weight proportions of the traditional Chinese medicine composition are as follows: 25 parts of five-finger peach, 20 parts of codonopsis, 20 parts of Chinese yam, 8 parts of white cardamom, 8 parts of agastache, 8 parts of light bamboo leaf, 15 parts of plantain, 20 parts of buzha leaf, 15 parts of fire charcoal, 8 parts of kapok flower, 8 parts of frangipani, 6 parts of tangerine peel, 8 parts of citronella, 15 parts of lycium barbarum sprouts, 12 parts of stir-fried rice sprouts, 8 parts of stir-fried radish seeds, 10 parts of euryale seed, 5 parts of schisandra fruit, 8 parts of pomegranate peel, and 6 parts of prepared licorice root.

[0062] Preparation method:

[0063] S1: Select, wash and dry all the above-mentioned medicinal materials, weigh them according to the amount, crush them separately and pass them through a 10-mesh sieve, mix them evenly, add water and decoct twice, filter, and combine the two filtrates; add 6 to 10 times the amount of water for the first time and decoct for 2 hours; add 3 to 6 times the amount of water for the second time and decoct for 1 hour.

[0064] S2: Concentrate the filtrate obtained in step S1 to obtain a clear paste with a relative density of 1.0 to 1.2 at 50 to 60°C. Dry the paste at low temperature, pulverize it, and pass it through a 120-mesh sieve. Add 1% to 3% magnesium stearate by weight of the clear paste, mix evenly, granulate, and fill into capsules to obtain the capsule preparation.

[0065] Example 5: Granules of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0066] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0067] Preparation method:

[0068] S1: Same as Example 4;

[0069] S2: Concentrate the filtrate obtained in step S1 to obtain a clear paste with a relative density of 1.0 to 1.2 at 50 to 60°C. Dry it at low temperature, pulverize it, and pass it through an 80-mesh sieve. Add 50% of the total weight of dextrin powder and an equal weight of sucrose powder to the clear paste and mix well. Make wet granules with 70% ethanol, dry them, granulate them, and package them into bags to obtain granules.

[0070] Example 6: A tablet of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0071] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0072] Preparation method:

[0073] S1: Same as Example 4;

[0074] S2: Concentrate the filtrate obtained in step S1 to obtain a clear paste with a relative density of 1.0 to 1.2 at 50 to 60°C. Dry it at low temperature, pulverize it, and pass it through a 100-mesh sieve. Add 30% of the total weight of dextrin to granulate the paste and dry it to obtain dry granules. Add 1% to 3% of the weight of magnesium stearate to the dry granules, mix well, compress and coat the mixture to make tablets.

[0075] Example 7: A pill-shaped traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0076] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0077] Preparation method:

[0078] S1: According to the weight proportions of the traditional Chinese medicine composition formula in Example 4, all the medicinal materials are selected, washed, dried, weighed, pulverized separately, passed through an 80-120 mesh sieve, and mixed evenly.

[0079] S2: Add 1.5 times the weight of honey to the mixed powder obtained in step 1, mix well, add water to form pills, and dry to obtain pills.

[0080] Example 8: An oral liquid of a traditional Chinese medicine composition for treating diarrhea due to spleen deficiency and damp-heat.

[0081] The weight proportions of the traditional Chinese medicine composition formula are consistent with those in Example 4.

[0082] Preparation method:

[0083] S1: Same as Example 4;

[0084] S2: Concentrate the filtrate obtained in step S1 to obtain a clear extract with a relative density of 1 to 1.2 at 50°C. Add sucrose, refined honey, and sorbic acid and mix well. The total amount of excipients is 50% of the total weight of the clear extract. Package and sterilize according to conventional methods to obtain the oral liquid.

[0085] Comparative Example 1

[0086] Formula: The difference from Example 1 is that the weight of the following components is reduced: 10g of Five-finger Peach, 5g of Codonopsis pilosula, and 5g of Chinese yam.

[0087] Preparation method: Same as in Example 1.

[0088] Comparative Example 2

[0089] Formula: The difference from Example 1 is that the white cardamom and agastache components are omitted.

[0090] Preparation method: Same as in Example 1.

[0091] This invention is applicable to diarrhea caused by spleen deficiency and damp-heat, especially diarrhea-predominant irritable bowel syndrome, chronic enteritis, and functional diarrhea.

[0092] Pregnant women should use with caution.

[0093] Clinical validation: The traditional Chinese medicine preparations for treating spleen deficiency and damp-heat type diarrhea prepared in Example 1, Comparative Example 1 and Comparative Example 2 of this invention were used in a clinical research program to further validate the beneficial effects of this invention.

[0094] The therapeutic effect of the composition in Experiment 1 on diarrhea-predominant irritable bowel syndrome

[0095] 1. Clinical subjects: 112 patients with diarrhea-predominant irritable bowel syndrome (IBS) and spleen deficiency with damp-heat syndrome were randomly divided into four treatment groups: control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group, with 28 patients in each group. Statistical analysis showed no significant differences in gender, age, or disease duration among the four groups (P > 0.05).

[0096] The four treatment groups included in this study received the following treatments: The control group received pinaverium bromide tablets, 50 mg three times daily, taken with meals. The other three groups received the traditional Chinese medicine decoctions of Example 1, Comparative Example 1, and Comparative Example 2 of this invention, one dose daily (divided into two doses, taken warm in the morning and evening). The treatment course for all four groups was 4 weeks. The clinical efficacy of each group was evaluated after the treatment.

[0097] 2. Diagnostic criteria

[0098] Western medicine diagnostic criteria: Refer to the Rome IV diagnostic criteria.

[0099] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria in the "Expert Consensus Opinion on the Diagnosis and Treatment of Irritable Bowel Syndrome with Traditional Chinese Medicine (2017)" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs".

[0100] 3. Efficacy evaluation criteria

[0101] Referring to the TCM syndrome efficacy evaluation standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the nimodipine method was used to calculate the efficacy index: [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%, which is divided into four levels: clinical cure, significant effect, effective, and ineffective.

[0102] Clinical cure: The main symptoms and signs have disappeared or basically disappeared, and the efficacy index is ≥95%;

[0103] Significant effect: Major symptoms and signs are significantly improved, with 70% ≤ efficacy index < 95%;

[0104] Effective: Major symptoms and signs show significant improvement, with 30% ≤ efficacy index < 70%;

[0105] Ineffective: The main symptoms and signs show no significant improvement or even worsen, and the efficacy index is <30%.

[0106] Overall efficacy (total effective rate) = (total number of cases - number of ineffective cases) / total number of cases × 100%.

[0107] 4. Treatment Results

[0108] After the treatment course, in the control group, 2 cases were cured, 8 cases showed significant improvement, 11 cases showed improvement, and 7 cases showed no improvement, with a total effective rate of 75.0%. In Example 1 group, 7 cases were cured, 15 cases showed significant improvement, 5 cases showed improvement, and 1 case showed no improvement, with a total effective rate of 96.4%. In Comparative Example 1 group, 3 cases were cured, 10 cases showed significant improvement, 9 cases showed improvement, and 6 cases showed no improvement, with a total effective rate of 78.6%. In Comparative Example 2 group, 4 cases were cured, 6 cases showed significant improvement, 14 cases showed improvement, and 4 cases showed no improvement, with a total effective rate of 85.7%. The traditional Chinese medicine preparation prepared using the raw materials and preparation method of this invention has a significant therapeutic effect on patients with diarrhea-predominant irritable bowel syndrome with spleen deficiency and damp-heat syndrome. Patients treated using Example 1 of this invention experienced no adverse reactions after the treatment course. Experimental results show that the clinical efficacy of Example 1 is significantly better than that of the control group. The efficacy of the traditional Chinese medicine preparation in Comparative Example 1 is significantly reduced due to the reduction in the weight of the components of *Ficus hirta*, *Codonopsis pilosula*, and *Dioscorea opposita*. The efficacy of Comparative Example 2 is weakened due to the omission of the components of *Eupatorium fortunei* and *Amomum villosum*.

[0109] The therapeutic effect of the composition in Experimental Example 2 on chronic enteritis

[0110] 1. Clinical subjects: 140 patients with chronic enteritis and spleen deficiency with damp-heat syndrome were randomly divided into four treatment groups: control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group, with 35 patients in each group. Statistical analysis showed no significant differences in gender, age, and disease course among the four groups (P>0.05).

[0111] The four treatment groups included in this study received the following treatments: The control group received compound glutamine enteric-coated capsules, 0.4g three times daily; and compound Lactobacillus acidophilus tablets, 1g three times daily. The other three groups received the traditional Chinese medicine decoction of Example 1, Comparative Example 1, and Comparative Example 2 of this invention, one dose daily (divided into two doses, taken warm in the morning and evening). The treatment course for all four groups was 4 weeks. The clinical efficacy of each group was evaluated after the treatment.

[0112] 2. Diagnostic criteria

[0113] Western medicine diagnostic criteria: Refer to the diagnostic criteria of "Western Medicine Internal Medicine".

[0114] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria in the "Expert Consensus Opinion on Diagnosis and Treatment of Diarrhea in Traditional Chinese Medicine (2017)" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs".

[0115] 3. Efficacy evaluation criteria

[0116] Referring to the TCM syndrome efficacy evaluation standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the nimodipine method was used to calculate the efficacy index: [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%, which is divided into four levels: clinical cure, significant effect, effective, and ineffective.

[0117] Clinical cure: The main symptoms and signs have disappeared or basically disappeared, and the efficacy index is ≥95%;

[0118] Significant effect: Major symptoms and signs are significantly improved, with 70% ≤ efficacy index < 95%;

[0119] Effective: Major symptoms and signs show significant improvement, with 30% ≤ efficacy index < 70%;

[0120] Ineffective: The main symptoms and signs show no significant improvement or even worsen, and the efficacy index is <30%.

[0121] Overall efficacy (total effective rate) = (total number of cases - number of ineffective cases) / total number of cases × 100%.

[0122] 4. Treatment Results

[0123] After the treatment course, in the control group, 3 cases were cured, 8 cases showed significant improvement, 15 cases showed improvement, and 9 cases showed no improvement, with a total effective rate of 74.3%. In Example 1 group, 11 cases were cured, 15 cases showed significant improvement, 7 cases showed improvement, and 2 cases showed no improvement, with a total effective rate of 94.3%. In Comparative Example 1 group, 5 cases were cured, 10 cases showed significant improvement, 12 cases showed improvement, and 8 cases showed no improvement, with a total effective rate of 77.1%. In Comparative Example 2 group, 6 cases were cured, 14 cases showed significant improvement, 9 cases showed improvement, and 6 cases showed no improvement, with a total effective rate of 82.9%. The traditional Chinese medicine preparation prepared using the raw materials and preparation method of this invention has a significant therapeutic effect on patients with chronic enteritis and spleen deficiency with damp-heat syndrome. Patients treated using Example 1 of this invention experienced no adverse reactions after the treatment course. Experimental results show that the clinical efficacy of the decoction prepared in Example 1 is significantly better than that of the control group. The efficacy of the traditional Chinese medicine preparation in Comparative Example 1 decreased due to the reduction in the weight of the components of five-finger peach, codonopsis, and Chinese yam; the efficacy of Comparative Example 2 was weakened due to the omission of the components of agastache and cardamom.

[0124] The therapeutic effect of the composition in Experimental Example 3 on functional diarrhea

[0125] 1. Subjects: 128 patients with functional diarrhea due to spleen deficiency and damp-heat syndrome were randomly divided into four groups: control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group, with 32 patients in each group. Statistical analysis showed no significant differences in gender, age, or disease duration among the four groups (P > 0.05).

[0126] The four treatment groups included in this study received the following treatments: The control group received oral Bifidobacterium triple live bacteria capsules, 2 capsules twice daily. The other three groups received the traditional Chinese medicine decoction of Example 1, Comparative Example 1, and Comparative Example 2 of this invention, one dose daily (divided into two doses, taken warm in the morning and evening). The treatment course for all four groups was 4 weeks. The clinical efficacy of each group was evaluated after the treatment.

[0127] 2. Diagnostic criteria

[0128] Western medicine diagnostic criteria: Refer to the diagnostic criteria for functional diarrhea in the Rome III diagnostic criteria for functional gastrointestinal disorders.

[0129] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria in the "Expert Consensus Opinion on Diagnosis and Treatment of Diarrhea in Traditional Chinese Medicine (2017)" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs".

[0130] 3. Efficacy evaluation criteria

[0131] Referring to the TCM syndrome efficacy evaluation standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the nimodipine method was used to calculate the efficacy index: [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%, which is divided into four levels: clinical cure, significant effect, effective, and ineffective.

[0132] Clinical cure: The main symptoms and signs have disappeared or basically disappeared, and the efficacy index is ≥95%;

[0133] Significant effect: Major symptoms and signs are significantly improved, with 70% ≤ efficacy index < 95%;

[0134] Effective: Major symptoms and signs show significant improvement, with 30% ≤ efficacy index < 70%;

[0135] Ineffective: The main symptoms and signs show no significant improvement or even worsen, and the efficacy index is <30%.

[0136] Overall efficacy (total effective rate) = (total number of cases - number of ineffective cases) / total number of cases × 100%.

[0137] 4. Treatment Results

[0138] After the treatment course, in the control group, 1 case was cured, 9 cases showed significant improvement, 15 cases showed improvement, and 7 cases showed no improvement, with a total effective rate of 78.1%. In Example 1 group, 6 cases were cured, 16 cases showed significant improvement, 8 cases showed improvement, and 2 cases showed no improvement, with a total effective rate of 93.8%. In Comparative Example 1 group, 2 cases were cured, 7 cases showed significant improvement, 17 cases showed improvement, and 6 cases showed no improvement, with a total effective rate of 81.3%. In Comparative Example 2 group, 4 cases were cured, 13 cases showed significant improvement, 10 cases showed improvement, and 5 cases showed no improvement, with a total effective rate of 84.4%. The traditional Chinese medicine preparation prepared using the raw materials and preparation method of this invention has a significant therapeutic effect on patients with functional diarrhea due to spleen deficiency and damp-heat syndrome. Patients treated using Example 1 of this invention experienced no adverse reactions after the treatment course. Experimental results show that the clinical efficacy of Example 1 is significantly better than that of the control group. The efficacy of the traditional Chinese medicine preparation in Comparative Example 1 decreased due to the reduction in the weight of the components of Five-Finger Peach, Codonopsis pilosula, and Dioscorea opposita. The efficacy of Comparative Example 2 was weakened due to the omission of the components of Eupatorium fortunei and Amomum villosum.

[0139] 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 diarrhea due to spleen deficiency and damp-heat, characterized in that, It is composed of the following ingredients in parts by weight: 20-30 parts of Five-Finger Peach, 15-30 parts of Codonopsis pilosula, 15-30 parts of Chinese yam, 5-10 parts of White Cardamom, 5-10 parts of Eupatorium fortunei, 6-10 parts of Lophatherum gracile, 9-20 parts of Plantago asiatica, 15-30 parts of Buzhaye, 9-15 parts of Polygonum cuspidatum, 6-9 parts of Bombax ceiba, 5-9 parts of Plumeria rubra, 3-6 parts of Citrus reticulata peel, 5-10 parts of Citrus medica, 9-30 parts of Rhizoma Cynodon dactylis, 10-15 parts of Rhizoma Cynodon dactylis, 5-10 parts of Rhizoma Radix Raphanus sativus, 9-15 parts of Fructus Euryale ferox, 2-6 parts of Fructus Schisandrae, 3-9 parts of Pericarpium Punicae, and 3-10 parts of Radix Glycyrrhizae Praeparata.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: 21-25 parts of Five-Finger Peach, 15-20 parts of Codonopsis pilosula, 16-20 parts of Chinese Dioscorea opposita, 6-8 parts of White Cardamom, 6-8 parts of Eupatorium fortunei, 6-8 parts of Lophatherum gracile, 10-15 parts of Plantago asiatica, 16-20 parts of Buzhaye, 10-15 parts of Polygonum cuspidatum, 6-8 parts of Bombax ceiba, 6-8 parts of Plumeria rubra, 5-6 parts of Citrus reticulata peel, 6-8 parts of Citrus medica, 10-15 parts of Ligusticum striatum, 10-12 parts of stir-fried rice sprouts, 6-8 parts of stir-fried radish seeds, 9-10 parts of Euryale ferox, 3-5 parts of Schisandra chinensis, 5-8 parts of pomegranate peel, and 5-6 parts of prepared licorice root.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, It is composed of the following ingredients in parts by weight: 25 parts of Five-Finger Peach, 20 parts of Codonopsis pilosula, 20 parts of Chinese yam, 8 parts of White Cardamom, 8 parts of Eupatorium fortunei, 8 parts of Lophatherum gracile, 15 parts of Plantago asiatica, 20 parts of Buzhaye, 15 parts of Polygonum cuspidatum, 8 parts of Bombax ceiba, 8 parts of Plumeria rubra, 6 parts of Citrus reticulata peel, 8 parts of Citrus medica, 15 parts of Rhizoma Citri Reticulatae, 12 parts of Rhizoma Citri Reticulatae, 8 parts of Rhizoma Raphanus sativus, 10 parts of Fructus Euryale ferox, 5 parts of Fructus Schisandrae, 8 parts of Pericarpium Citri Reticulatae, and 6 parts of Radix Glycyrrhizae Praeparata.

4. A traditional Chinese medicine oral preparation, characterized in that, The oral preparation comprises any one of the traditional Chinese medicine compositions according to claims 1 to 3.

5. The oral preparation of traditional Chinese medicine according to claim 4, characterized in that, The oral preparations are decoctions, capsules, granules, tablets, pills, or oral liquids.

6. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the oral preparation of traditional Chinese medicine according to claim 4 or 5 in the preparation of a drug for treating diarrhea caused by spleen deficiency and damp-heat.

7. The application according to claim 6, characterized in that, The diarrhea caused by spleen deficiency and damp-heat is diarrhea-predominant irritable bowel syndrome.

8. The application according to claim 6, characterized in that, The diarrhea caused by spleen deficiency and damp-heat is chronic enteritis.

9. The application according to claim 6, characterized in that, The diarrhea caused by spleen deficiency and damp-heat is functional diarrhea.