Traditional Chinese medicine oral decoction for ulcerative colitis with large intestine damp-heat syndrome

Abstract

This invention relates to the field of traditional Chinese medicine technology, specifically to an oral decoction of traditional Chinese medicine for ulcerative colitis with damp-heat syndrome of the large intestine. The composition of this invention consists of Astragalus membranaceus, Sargentodoxa cuneata, raw Coix lacryma-jobi, Agrimonia pilosa, charred Sanguisorba officinalis, cuttlebone, Bletilla striata, Panax notoginseng powder, Fagopyrum dibotrys, Benincasa hispida seeds, Alpinia oxyphylla, stir-fried Atractylodes lancea, Gleditsia sinensis thorns, Notopterygium incisum, and Angelica pubescens. The combined effects of these herbs are to strengthen the spleen and stop diarrhea, promote blood circulation and stop bleeding, promote tissue regeneration and reduce swelling, and astringe sores, with synergistic effects. Used in the acute phase of ulcerative colitis (damp-heat syndrome of the large intestine), it can improve the patient's clinical symptoms, rapidly control mucus and bloody stools, eliminate inflammation, and promote the healing of intestinal mucosal ulcers.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to an oral decoction of traditional Chinese medicine for ulcerative colitis with damp-heat syndrome of the large intestine. Background Technology

[0002] Ulcerative colitis (UC) is a chronic, nonspecific inflammatory bowel disease with an unclear etiology, prevalent in Western countries such as Europe and the United States. In my country, the incidence of UC is 1.18 per 100,000 people, primarily affecting young adults aged 20-49. It seriously impacts the physical health and quality of life of the Chinese population, becoming a common and difficult-to-treat disease of the digestive system.

[0003] While significant progress has been made in the treatment of ulcerative colitis (UC) with Western medicine, several issues remain to be addressed, such as: how to treat patients with relapse or those maintaining remission; how to treat the small number of patients with severe relapse or chronic non-remission; glucocorticoid dependence and resistance; the side effects of glucocorticoids and immunosuppressants; the high cost of biologics; easy relapse upon discontinuation of medication; and poor long-term efficacy. Traditional Chinese medicine (TCM), due to its safety, effectiveness, low price, good long-term efficacy, and low relapse rate, is widely welcomed by patients and plays an important role in the treatment of UC. According to literature reports, the treatment choices for UC patients in my country are as follows: 18.6% use Western medicine alone, 20.1% use TCM alone, and 59.1% use a combination of Western and TCM. This indicates that a combination of Western and TCM is still the first choice for ulcerative colitis patients in my country, representing a significant market demand. The "2023 Chinese Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease" explicitly recommends the use of TCM in treatment. However, the types of TCM preparations currently available for treating ulcerative colitis are still relatively limited, and their efficacy is not very significant. Summary of the Invention

[0004] To address the problems existing in the prior art, the purpose of this invention is to provide a traditional Chinese medicine oral decoction for ulcerative colitis with damp-heat syndrome of the large intestine. The oral decoction disclosed in this invention is used to treat the acute phase of ulcerative colitis (damp-heat syndrome of the large intestine), and can rapidly control mucus and bloody stools, eliminate inflammation, and promote the healing of intestinal mucosal ulcers.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solutions.

[0006] This invention provides a traditional Chinese medicine composition for ulcerative colitis with damp-heat syndrome of the large intestine, characterized in that the raw materials of the composition include the following components: Astragalus membranaceus, Sargentodoxa cuneata, raw Coix lacryma-jobi, Agrimonia pilosa, charred Sanguisorba officinalis, cuttlebone, Bletilla striata, Panax notoginseng powder, Fagopyrum dibotrys, Benincasa hispida seeds, Alpinia oxyphylla, stir-fried Atractylodes lancea, Gleditsia sinensis thorns, Notopterygium incisum, and Angelica pubescens.

[0007] Further, the raw materials of the composition include the following components in parts by weight: Astragalus membranaceus 30-100g, Sargentodoxa cuneata 20-30g, raw Coix lacryma-jobi 20-30g, Agrimonia pilosa 30-100g, Sanguisorba officinalis charcoal 15-30g, Cuttlebone 10-20g, Bletilla striata 3-6g, Panax notoginseng powder 3-6g, Fagopyrum dibotrys 20-30g, Benincasa hispida seeds 15-30g, Alpinia oxyphylla 20-45g, stir-fried Atractylodes lancea 20-30g, Gleditsia sinensis thorns 10-20g, Notopterygium incisum 5-10g, Angelica pubescens 5-10g.

[0008] Furthermore, the raw materials of the composition include the following parts by weight of raw materials: Astragalus membranaceus 30g, Sargentodoxa cuneata 20g, Coix lacryma-jobi 30g, Agrimonia pilosa 50g, Sanguisorba officinalis charcoal 20g, Cuttlebone 20g, Bletilla striata 6g, Panax notoginseng powder 3g, Fagopyrum dibotrys 30g, Benincasa hispida seeds 20g, Alpinia oxyphylla 30g, Atractylodes lancea (fried) 30g, Gleditsia sinensis thorns 15g, Notopterygium incisum 6g, Angelica pubescens 6g.

[0009] The present invention also provides the application of the traditional Chinese medicine composition described in any one of the above-mentioned claims in the preparation of a medicine for treating ulcerative colitis with damp-heat syndrome of the large intestine.

[0010] The present invention also provides a traditional Chinese medicine oral decoction for ulcerative colitis with damp-heat syndrome of the large intestine, comprising any of the above-described traditional Chinese medicine compositions.

[0011] Furthermore, the oral decoction for treating ulcerative colitis with damp-heat syndrome of the large intestine is characterized by the following preparation steps: soaking in 900mL of cold water (excluding Panax notoginseng powder) for 30 minutes, then boiling over high heat until boiling, then reducing to low heat and simmering for 40 minutes; simmering to obtain 450mL of medicinal liquid, adding Panax notoginseng powder, and dividing into 3 portions of 150mL each.

[0012] Furthermore, the oral decoction is taken orally twice a day, 30-60 minutes after breakfast and lunch.

[0013] The formulation compatibility principle of this invention is as follows.

[0014] The principal ingredient.

[0015] Astragalus, sweet and warm in nature, enters the lung and spleen meridians. Its functions include tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, and promoting tissue regeneration and detoxification. It is primarily used to treat all syndromes of qi and blood deficiency, such as spleen deficiency diarrhea, rectal prolapse, carbuncles that are difficult to heal or have been ulcerated for a long time. The *Shennong Bencao Jing* states, "Astragalus is the main treatment for carbuncles, chronic sores, draining pus and relieving pain." The *Rihua Zi* states, "Astragalus strengthens qi and bones, promotes muscle growth and replenishes blood, breaks up masses, and treats intestinal wind, dysentery, etc." The *Yixue Qiyuan* states, "Astragalus is good at treating spleen and stomach weakness, sores with poor blood circulation, internal support for yin syndromes, and sores." The *Bencao Beiyao* states, "Astragalus generates blood, promotes tissue regeneration, drains pus and promotes internal support; it is a holy medicine for carbuncles and sores." The *Bencao Huiyan* states, "For carbuncles with pus and blood ulceration, where yang qi is deficient and the wound does not heal, astragalus can promote muscle growth, and it is also effective for yin sores that do not heal." "Astragalus can help to expel pus and toxins, especially in cases where the Yang Qi is deficient but the ulceration is not yet complete." The *Ben Cao Zheng* states, "It treats diarrhea and dysentery with turbid discharge because it strengthens the Qi and removes the ulceration itself; hence the saying 'lifting up what is trapped.'" "Raw Astragalus is slightly cooling and can treat carbuncles and boils." The *Yao Pin Hua Yi* states, "Astragalus treats diarrhea due to spleen deficiency, chronic malaria and dysentery, and hematemesis and epistaxis." The *Ben Jing Feng Yuan* states, "(Astragalus) enters the lungs to strengthen the exterior and prevent spontaneous sweating due to deficiency; it enters the spleen to expel ulcerated carbuncles and boils." The *Ben Jing* first mentions that for chronic carbuncles and boils, to drain pus and relieve pain, raw Astragalus is used to clear the heat of the Wei Qi. It is evident that Astragalus not only has a tonic effect on patients with chronic diarrhea and dysentery, but also promotes tissue regeneration and detoxification. It is suitable for patients with significant microscopic mucosal changes during the active phase of ulcerative colitis. In particular, since the lungs and large intestine are internally and externally related, Astragalus readily enters the lung and spleen meridians. It not only tonifies lung qi and astringes the large intestine to prevent incomplete bowel movements, but also tonifies spleen qi and helps the spleen ascend clear qi. This restores the spleen and stomach's regulatory mechanism, allowing the spleen and stomach to ascend and descend in harmony, dry and dampness to balance each other, and digestion and transportation to be coordinated, thus stopping diarrhea. Furthermore, it can nourish muscles and strengthen defensive qi. Therefore, Astragalus is an indispensable herb and the principal herb.

[0016] *Sargentodoxa cuneata*, bitter and neutral in nature, enters the large intestine and liver meridians. Its functions include detoxification, reducing swelling, promoting blood circulation and relieving pain, dispelling wind and dampness, and killing parasites. It is primarily used to treat intestinal abscesses, dysentery, mastitis, dysmenorrhea, amenorrhea, traumatic injuries, rheumatic pain, and abdominal pain due to intestinal parasites. *New Compilation of Herbal Medicines* states, "*Sargentodoxa cuneata* is used as an astringent. It treats excessive menstruation and dysmenorrhea in women, and cures bloody dysentery and intestinal abscesses." This shows that *Sargentodoxa cuneata* has astringent properties while promoting blood circulation, just as Ye Tianshi said, "Prolonged illness enters the collaterals" and "Prolonged illness inevitably leads to blood stasis." While promoting blood circulation, it also has astringent effects on the intestines, which is very beneficial for patients with ulcerative colitis, damp-heat syndrome of the large intestine, bloody stools, and long-term illness.

[0017] When Astragalus membranaceus and Sargentodoxa cuneata are used together, they work synergistically to promote tissue regeneration, eliminate carbuncles, and heal sores. The combination of these two herbs is beneficial without causing stagnation, and effective without harming the body's vital energy. They also have the advantage of combining tonification and purgation. Therefore, these two herbs are used throughout the entire treatment and serve as the principal herbs.

[0018] Minister's medicine.

[0019] Job's tears (Coix seed) is sweet, bland, and slightly cold in nature. It enters the spleen, stomach, and lung meridians. Its functions include promoting diuresis and strengthening the spleen, relaxing muscles and relieving numbness, clearing heat and draining pus. It is primarily used to treat diarrhea, lung pain, and intestinal pain. The *Compendium of Materia Medica* states, "Job's tears strengthen the spleen and benefit the stomach, nourish the lungs and clear heat, dispel wind and eliminate dampness." The *Compendium of Materia Medica* states, "Job's tears can strengthen the spleen and benefit the stomach; it is used for diarrhea and edema." The *Commentary on the Materia Medica* states, "Job's tears, being dry in nature, can eliminate dampness; its sweet taste can enter the spleen and nourish it; its blandness can promote diuresis, benefit the intestines and stomach, and reduce edema." The *Medicinal Properties Explained* states, "Job's tears can strengthen spleen yin and greatly benefit the intestines and stomach. It is primarily used to treat diarrhea due to spleen deficiency." This leads to edema. The *Compendium of Materia Medica* states, "Job's tears are excellent at promoting urination without depleting one's true yin energy. They are most suitable for those with excessive dampness in the lower body. The dosage should be adjusted according to the severity of the illness to avoid harming yin and yang, and to easily eliminate dampness." The *Essentials of Herbal Properties* states, "Job's tears treat injuries from falls, stop bleeding, and disperse sores and toxins." The *Mirror of Herbs* states, "It lowers qi and invigorates blood, treats various diseases, disperses fullness and distension, treats bleeding from falls, metrorrhagia, and intestinal bleeding." The *Supplement to the Compendium of Materia Medica* states, "Ge Zu's prescription: Job's tears treat malaria, intestinal bleeding, and hemorrhoids." The fundamental pathogenesis of ulcerative colitis, according to Traditional Chinese Medicine, is a mixture of deficiency and excess in the spleen and stomach. Raw Job's tears tonify the spleen and stomach, clear heat and eliminate dampness, and also have the properties of draining pus. It also has the effect of relieving spasms and pain. The *Classic of Materia Medica* states, "It treats muscle spasms and contractures, inability to bend or stretch, rheumatic pain, and lowers qi." Looking at the famous physician Zhang... In Zhang Zhongjing's *Treatise on Febrile and Miscellaneous Diseases*, the formula Yi Yi Fu Zi Bai Jiang San states, "For intestinal abscess, the skin is rough and scaly, the abdominal skin is tense, and when pressed, it is soft, like a swelling. There is no accumulation in the abdomen, no fever, and the pulse is rapid. This indicates that there is abscess pus in the intestines, and Yi Yi Fu Zi Bai Jiang San is the main treatment." The formula Yi Yi Fu Zi San also states, "For chest pain with varying degrees of urgency, Yi Yi Fu Zi San is the main treatment." These descriptions demonstrate the remarkable efficacy of coix seed in relieving urgency and pain, clearing heat and dampness, reducing swelling and draining pus.

[0020] Agrimony, bitter and astringent in nature, neutral in nature. It enters the lung, liver, and spleen meridians. Its functions are to astringe and stop bleeding, eliminate stagnation and stop diarrhea, detoxify and reduce swelling. It is mainly used to treat hemoptysis, hematemesis, epistaxis, hematuria, hematochezia, metrorrhagia, external bleeding, diarrhea, diseases, exhaustion and fatigue, malaria, and boils and carbuncles. Agrimony is most effective in replenishing qi and strength, and is also known as the "exhaustion herb". It is good at treating exhaustion and fatigue, chronic loose stools, various deficiencies and injuries, and in cases where there is no complete qi after vomiting and diarrhea, and qi deficiency leads to loose stools, which recurs. Therefore, it is necessary to replenish all deficiencies. Agrimony replenishes without causing heat, and is cooling and moistening without being cold. It is good at replenishing qi and strength, so it is used as an assistant herb.

[0021] Burnt Sanguisorba officinalis charcoal is primarily used for hemostasis. It is mainly used to treat bleeding disorders such as hematochezia, hematuria, and metrorrhagia. Burnt Sanguisorba officinalis cools the blood, promotes blood circulation, and stops bleeding. When charred, its blood-cooling effect is weak, but its hemostatic effect is strong. For every degree of bleeding, there is a degree of blood stasis; for every degree of blood stasis, there is a degree of blood deficiency; and for every degree of blood deficiency, there is a degree of deficiency heat. Burnt Sanguisorba officinalis charcoal cools the blood, promotes blood circulation, and stops bleeding. For patients with damp-heat syndrome in the large intestine, where heat is more prominent than dampness, and the heat evil has scorched the intestinal vessels leading to bleeding, as shown by colonoscopy, with mucosal bleeding, erosion, and increased mucosal fragility, burnt Sanguisorba officinalis charcoal can effectively promote blood circulation, remove blood stasis, cool the blood, and stop bleeding.

[0022] Sepia, salty, astringent, warm in nature. It acts on the liver and kidney meridians. Its functions include arresting bleeding, astringing essence and arresting vaginal discharge, alleviating acid regurgitation, and promoting the subsidence of damp eczema. It is mainly used to treat hematemesis, epistaxis, metrorrhagia and menorrhagia, hematochezia, hematuria, traumatic bleeding, spermatorrhea and emission due to kidney deficiency, leukorrhea, epigastric pain with gastric discomfort, acid regurgitation, eczema and ulcer. *Depei Bencao* says: "It promotes blood circulation, dispels cold-dampness, treats bloody dysentery, eliminates phlegm and malaria, and also treats leukorrhea, swelling and pain of vulva erosion, fright invading the abdomen, and umbilical pain." *Bielu* says: "The bone of sepia is a drug for nourishing yin and blood. Its taste is salty and it enters the blood. Therefore, blood depletion, emaciation, amenorrhea, metrorrhagia and leukorrhea are the diseases of Jueyin meridian. It is warm and dries dampness, so it also treats ulcers with much purulent discharge." *Yugang Yaojie* says: "Sepia officinalis can astringe fresh blood and disperse stasis. Its saltiness can enter the lower jiao, and its astringency can arrest involuntary discharge and consolidate the intestine. For patients with chronic diarrhea and dysentery, sepia can astringe the stool and takes effect quickly."

[0023] Bletilla striata, bitter, sweet, astringent, slightly cold in nature. It acts on the lung and kidney meridians. Its functions include arresting bleeding, detumescence and promoting granulation. It is mainly used to treat hemoptysis, hematemesis, epistaxis, hematochezia, traumatic bleeding, swelling toxin, scald and burn, chapped hands and feet, anal fissure. *Shennong Bencaojing* says: "Bletilla striata is mainly used to treat carbuncles, ulcers, gangrene, injury of yin and necrosis of muscles, pathogenic factors in the stomach, sudden attack of wind, fright epilepsy, flaccidity and inability to contract." *Rihuazi Bencao* says: "It arrests fright epilepsy, blood epilepsy, carbuncles, red eyes, goiter, back carbuncle, scrofula, intestinal wind, hemorrhoids, knife and arrow wounds, contusion and injury, warm malaria, bloody dysentery, scald and burn, promotes granulation and relieves pain, and treats wind bi." *Bencao Huiyan* says: "Bletilla striata is a drug for astringing qi, eliminating phlegm, arresting bleeding and relieving pain. It can disperse carbuncles, support the subsidence of ulcers, remove necrotic muscles, clean up pus and blood, and has the wonderful effect of promoting the subsidence of old sores and generating new tissues." *Bencao Qiuzhen* says: "Bletilla striata has both dispersion in astringency and breaking in tonification, so it is also recorded in books to remove putrefaction, disperse stasis and generate new tissues." *Bencao Zhengyi* says: "Bletilla striata is rich in viscous substances and lipid fluids. It can not only disperse carbuncles and reduce swelling and heat when the carbuncle is not formed, but also remove putrefaction and promote granulation when the carbuncle has ulcerated. Bletilla striata is rich in lipid fluids, which can protect the wound surface, prevent the ulcerated surface in the intestine from being stimulated by other substances, and prevent continuous exudation and resulting in continuous diarrhea."

[0024] Panax notoginseng, sweet, slightly bitter, warm in nature. It acts on the liver, stomach, heart and large intestine meridians. Its functions include arresting bleeding, dispersing stasis, detumescence and alleviating pain. It is mainly used to treat hematemesis, hemoptysis, hematuria, hematochezia, bloody dysentery, metrorrhagia and menorrhagia, postpartum hemorrhage, traumatic bleeding, falls and injuries, chest impediment with heart pain, chronic pain in the wrist and hypochondrium, abdominal mass, blood stasis and amenorrhea, dysmenorrhea, postpartum stasis and abdominal pain, carbuncles and sores with swelling and pain. *Compendium of Materia Medica* says: "Panax notoginseng arrests bleeding, disperses blood stasis and alleviates pain. For those with bleeding due to sword and arrow wounds, falls and injuries, and contusions and wounds where bleeding does not stop, chew it and apply it, or sprinkle the powder on the wound, and the bleeding will stop immediately. It is also used to treat hematemesis, epistaxis, hematochezia, bloody dysentery, carbuncles and sores." *Zhongzhong Canxilu* says: "Panax notoginseng can also treat bleeding from the two excretory organs, metrorrhagia of women, bloody dysentery with bright red blood that has not healed for a long time, erosion and ulceration in the intestine, and the dysentery with purple and fetid discharge mixed with fat membrane, which means the intestine is about to perforate (Panax notoginseng can transform putrefaction and generate new tissues, so it can be used to treat this disease)."

[0025] The combination of these herbs arrests bleeding, promotes granulation, eliminates carbuncles and astringes ulcers.

[0026] Assistant herbs.

[0027] Golden buckwheat is sour, bitter, and cold in nature. It enters the lung, stomach, and liver meridians. Its functions include clearing heat and detoxifying, resolving phlegm and soothing the throat, and promoting blood circulation and reducing swelling. It is mainly used to treat lung abscess, cough and asthma due to lung heat, sore throat, and dysentery. The *Xinxiu Bencao* states: "It treats various types of dysentery, including red and white dysentery, cold and hot dysentery, stops bleeding, breaks up blood stasis, treats red and white leukorrhea, and promotes tissue regeneration." The *Bencao Shiyi* states: "It treats carbuncles, malignant sores, toxic swellings, red and white rashes, insect bites, silkworm bites, snake bites, and dog bites. It can be applied to the sores with vinegar, or the pounded stems and leaves can be applied topically; to prevent poisoning, it can also be boiled and taken orally."

[0028] Winter melon seeds are sweet and slightly cold in nature. They enter the lung and large intestine meridians. Their functions include clearing the lungs and resolving phlegm, eliminating carbuncles and draining pus, and promoting diuresis. They are mainly used to treat cough with phlegm and heat, lung pain, intestinal abscess, leukorrhea, edema, and urinary tract infections. The *Diannan Bencao Tushuo* states that they "treat intestinal abscesses." The *Bencao Jing Shu* says, "They open the stomach and invigorate the spleen, treating tenesmus after dysentery." The *Changsha Yaoxie* states, "They clear the lungs and moisten the intestines, draining pus and resolving blood stasis." The *Bencao Shengchang* states, "Raw seeds are neutral in nature, clearing the lungs and generating fluids; stir-fried seeds are warm in nature, moistening the intestines and harmonizing the middle jiao." The *Bencao Cuoyao* states, "They are an essential medicine for malaria with chills and fever, and for intestinal spasms."

[0029] When buckwheat and winter melon seeds are used together, they are particularly effective in clearing and purifying lung qi. Since the lungs and large intestine are internally and externally related, excessive diarrhea with mucus and blood in the stool can be relieved by clearing and purifying lung qi and restoring its cleanliness. This will naturally clear the qi of the large intestine, allowing the phlegm and blood stasis in the lungs to be expelled, and thus the phlegm and blood stasis in the large intestine to be expelled as well.

[0030] Alpinia oxyphylla, pungent and warm in nature, enters the spleen and kidney meridians. Its functions include warming the spleen to stop diarrhea, warming the kidneys to reduce urination and consolidate essence. It is primarily used to treat spleen and stomach deficiency-cold, and diarrhea. The *Compendium of Materia Medica* states, "It treats abdominal pain due to cold." The *Essentials of Materia Medica* states, "It can astringe essence and consolidate qi, warm the middle and promote appetite. It treats vomiting and diarrhea, cold invading the stomach, abdominal pain due to cold, metrorrhagia, leukorrhea, and seminal emission." The *Commentary on the Materia Medica* states, "Alpinia oxyphylla kernel, due to its astringent properties, treats seminal emission, urinary incontinence, and dribbling urination, all symptoms of kidney qi deficiency." The *Seeking Truth in Materia Medica* states, "Alpinia oxyphylla, pungent and hot in nature, is specifically used to dry the spleen and warm the stomach, and to astringe the rebellious qi of the spleen and kidneys, allowing it to return to its source." In the Suoquan Pill, Alpinia oxyphylla kernel is selected to warm the lower burner, tonify kidney qi, and prevent loose stools. In the Five Elements theory of mutual generation and restraint, fire generates earth; this is a method of tonifying fire and earth.

[0031] Stir-fried Atractylodes lancea is pungent, bitter, and warm in nature. It enters the spleen, stomach, and liver meridians. Its functions include drying dampness and strengthening the spleen, dispelling wind-dampness, and improving eyesight. It is primarily used to treat dampness affecting the spleen and stomach, fatigue, lethargy, chest tightness, abdominal distension, loss of appetite, vomiting, diarrhea, phlegm retention, edema, external syndromes with dampness, headache and body aches, arthralgia due to dampness, and soreness and heaviness in the limbs. The Compendium of Materia Medica states, "It treats damp phlegm retention, or stagnation of blood forming sacs, as well as spleen dampness causing turbid leukorrhea, and slippery diarrhea." The Jade Olive Pharmacopoeia states, "It dries the earth, promotes urination, eliminates phlegm and fluid retention, and promotes blood circulation and relieves stagnation." The Origin of Materia Medica states, "It strengthens the spleen, stops watery diarrhea, treats diarrhea caused by food poisoning or summer heat, and treats spleen dampness causing bloody stools." Atractylodes lancea strengthens the spleen and dispels dampness. Its aromatic and drying nature is very compatible with spleen qi. Therefore, Atractylodes lancea is good at tonifying spleen qi and helping the spleen ascend clear qi. The Inner Canon states, "When clear qi is downward, it causes diarrhea; when clear qi ascends, diarrhea stops."

[0032] Use medicine.

[0033] Gleditsia sinensis thorns are pungent and warm in nature. They enter the liver, lung, and stomach meridians. Their functions include reducing swelling and promoting pus drainage, dispelling wind, and killing parasites. They are primarily used to treat carbuncles, boils, and stubborn skin diseases caused by wind. The *Supplement to the Compendium of Materia Medica* states: "It treats carbuncles that have already ulcerated, drawing the pus to the affected area; it is very effective." The *Compendium of Materia Medica* says: "It treats carbuncles, mastitis, wind-related sores, retained placenta, and kills parasites." The *Seeking the Origins of Materia Medica* states: "It can expel wind toxins from the blood, treat wind-related diseases, kill parasites, break up painful boils and sores, and treat sores in the intestines."

[0034] Notopterygium root (Qianghuo) is pungent, bitter, and warm in nature. It enters the bladder and kidney meridians. Its functions include dispersing external cold, expelling wind and dampness, benefiting joints, and relieving pain. It is primarily used to treat exogenous wind-cold, headache without sweating, wind-cold-dampness arthralgia, edema due to wind, and carbuncles and boils. The *Xinxiu Bencao* states, "For treating wind-related conditions, use Angelica pubescens; for treating edema, use Notopterygium root." It further states, "Notopterygium root is a bitter and pungent herb. Its function is to reach the limbs, unblock blood vessels, attack pathogenic factors, and disperse wind-cold and wind-dampness. Therefore, for carbuncles, it can drain pus and promote tissue regeneration; for eye conditions, it can treat blurred vision, swelling, and difficulty in opening the eyes; for wind-related conditions, it can treat flaccidity, spasms, epilepsy, carbuncles, paralysis, and fainting. Because it is light and not heavy, clear and not turbid, pungent and dispersing, and its nature is continuous, it ascends to the head and descends to the feet, reaching all parts of the body to clear pathogenic factors from the qi level."

[0035] Angelica pubescens, bitter, pungent, and slightly warm in nature, enters the kidney and bladder meridians. Its functions include dispelling wind and dampness, dispersing cold and relieving pain. It is primarily used to treat wind-cold-dampness arthralgia, lower back and knee pain, headache, and toothache. Zhang Yuansu stated, "It disperses carbuncles and blood stasis." The *Compendium of Materia Medica* states, "All wind-related symptoms, such as inability to bend or straighten the head and neck, inability to flex or extend the waist and knees, or numbness and pain making walking difficult, are caused by wind and cold, and damage from summer heat and dampness. Angelica pubescens, with its bitter, pungent, and warm properties, must be used to invigorate qi and blood, and dispel cold pathogens. Therefore, the *Compendium of Materia Medica* states that it can disperse beriberi, resolve abdominal distension, treat fatigue, and eliminate carbuncles and swellings." The *Medicinal Properties Explained* states, "(Angelica pubescens) can treat wind, and wind overcomes dampness; it is a particularly effective remedy for dispelling dampness."

[0036] When notopterygium root and angelica root are used together, both are considered wind-dispelling herbs. Wind-dispelling herbs have three characteristics: First, wind can soothe the liver. Wind flows through the liver, so the liver qi is soothed, the wood qi flows smoothly, and it does not overpower the spleen, thus the spleen and stomach become healthy. Second, wind can overcome dampness, thus transforming dampness. Third, wind can ascend clear qi, so the yang qi rises, dampness is transformed, and diarrhea stops.

[0037] The composition of this invention comprises Astragalus membranaceus, Sargentodoxa cuneata, raw Coix lacryma-jobi, Agrimonia pilosa, charred Sanguisorba officinalis, cuttlebone, Bletilla striata, Panax notoginseng powder, Fagopyrum dibotrys, Benincasa hispida seeds, Alpinia oxyphylla, stir-fried Atractylodes lancea, Gleditsia sinensis thorns, Notopterygium incisum, and Angelica pubescens. The combined effects of these herbs are to strengthen the spleen and stop diarrhea, promote blood circulation and stop bleeding, promote tissue regeneration and reduce swelling, and astringe sores, with synergistic effects. While improving the patient's clinical symptoms, it also addresses their endoscopic findings, promoting endoscopic mucosal healing.

[0038] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0039] Based on traditional Chinese medicine theory and with a problem-oriented approach, this invention delves into the damp-heat syndrome of ulcerative colitis, resulting in an oral decoction for this condition. This oral decoction is used during the acute phase of ulcerative colitis (damp-heat syndrome of the large intestine) to rapidly control mucus and bloody stools, eliminate inflammation, and promote the healing of intestinal mucosal ulcers. Detailed Implementation

[0040] The present invention will be further described in detail below with reference to specific embodiments. However, this should not be construed as limiting the scope of the above-described subject matter of the present invention to the following embodiments; all technologies implemented based on the content of the present invention fall within the scope of the present invention.

[0041] Unless otherwise specified, all reagents and materials used in this invention are commercially available.

[0042] Example 1. Specific dosage and preparation method of the formulation of the present invention.

[0043] Formula and dosage: Astragalus membranaceus 30g, Sargentodoxa cuneata 20g, Coix lacryma-jobi 30g, Agrimonia pilosa 50g, Sanguisorba officinalis charcoal 20g, Cuttlebone 20g, Bletilla striata 6g, Panax notoginseng powder 3g, Fagopyrum dibotrys 30g, Benincasa hispida seeds 20g, Alpinia oxyphylla 30g, Atractylodes lancea (fried) 30g, Gleditsia sinensis thorns 15g, Notopterygium incisum 6g, Angelica pubescens 6g.

[0044] Preparation method: Soak in 900mL of cold water (except for Panax notoginseng powder) for 30 minutes, then bring to a boil over high heat, then reduce to low heat and simmer for 40 minutes. Boil to obtain 450mL of decoction, add Panax notoginseng powder, divide into 3 portions of 150mL each, and take orally twice a day, 30-60 minutes after breakfast and lunch.

[0045] Example 2. Experimental demonstration of the efficacy of the formulation of the present invention.

[0046] We collected case information from 40 patients diagnosed with damp-heat type ulcerative colitis at the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from January 2021 to December 2023. Patients were divided into two groups: a TCM group (oral TCM twice daily plus mesalazine 4.0g once daily) and a Western medicine group (mesalazine 4.0g once daily). Modified Mayo Cognitive Assessment (MCA) scores and TCM symptom quantification scores were compared between the two groups before treatment and 8 weeks after treatment.

[0047] The specific dosage of the oral Chinese medicine is as follows: Astragalus membranaceus 30g, Sargentodoxa cuneata 20g, Coix lacryma-jobi 30g, Agrimonia pilosa 50g, Sanguisorba officinalis charcoal 20g, Sepia esculenta 20g, Bletilla striata 6g, Panax notoginseng powder 3g, Fagopyrum dibotrys 30g, Benincasa hispida seeds 20g, Alpinia oxyphylla 30g, Atractylodes lancea (fried) 30g, Gleditsia sinensis thorns 15g, Notopterygium incisum 6g, Angelica pubescens 6g. The preparation method is the same as described in Example 1.

[0048] Table 1 Improved Mayo Scoring

[0049] .

[0050] Note: Each subject served as a self-control to assess the degree of abnormality in bowel movement frequency; the daily bleeding score represented the most severe bleeding in 1 day; the physician's overall evaluation included 3 criteria: the subject's review of abdominal discomfort, overall well-being, and other performance: total score <2 points and no individual sub-score >1 points indicated remission; 3-5 points indicated mild activity; 6-10 points indicated moderate activity; and 11-12 points indicated severe activity.

[0051] Table 2. Traditional Chinese Medicine Syndrome Scoring Table

[0052] .

[0053] The experimental results and statistical data are as follows.

[0054] 1. Post-hoc analysis using ANOVA test of Mayo scores. The comparison results are shown in the table below.

[0055] .

[0056] After treatment, the modified Mayo scores of the two groups were compared before and after treatment, and the comparison was performed post-hocly using ANOVA. Before treatment, the mean Mayo scores of the two groups were: the traditional Chinese medicine group (TCM group) was 7.15±1.39, and the mean score of the Western medicine group was 7.55±1.43. There was no statistically significant difference between the two groups before treatment (P=0.100, P>0.05), indicating comparability. After treatment, the mean Mayo score of the TCM group was 3.85±2.62, and the mean score of the Western medicine group was 5.55±1.93. The difference between the two groups after treatment was statistically significant (P=0.006, P≤0.05). The individual before-and-after comparisons within the TCM group and the Western medicine group were statistically significant (p<0.001), indicating that both treatment methods were effective, with the TCM group showing better efficacy than the Western medicine group.

[0057] 2. Traditional Chinese Medicine syndrome score.

[0058] 2.1 Rank sum test of TCM syndrome scores (the observation group was the TCM group, and the control group was the Western medicine group), the results are shown in the table below.

[0059] .

[0060] In the traditional Chinese medicine (TCM) group, 0 patients (10%) were cured, 9 patients (45%) showed significant improvement, 10 patients (50%) showed improvement, and 1 patient (10%) showed no improvement. The overall effective rate in the TCM group was 95% (19 / 20). In the Western medicine (Western medicine) group, 0 patients (60%) were cured or showed significant improvement, 57 patients (60%) showed improvement, and 5 patients (25%) showed no improvement. The overall effective rate in the Western medicine group was 75% (15 / 20). Let cured = 1, significant improvement = 2, improvement = 3, and no improvement = 4. Using the rank-sum test, P = 0.001 (< 0.05), indicating a statistically significant difference.

[0061] 2.2 Comparison of total TCM syndrome scores before and after treatment.

[0062] .

[0063] After treatment, the modified Mayo scores of the two groups were compared before and after treatment, and the comparison was performed post-hocly using ANOVA. Before treatment, the Mayo scores of the two groups were as follows: the quartiles of the traditional Chinese medicine group were 20 (19, 21), and the quartiles of the Western medicine group were 20.5 (19.25, 22). There was no statistically significant difference between the two groups before treatment (P=0.925, P>0.05), indicating comparability. After treatment, the quartiles of the traditional Chinese medicine group were 7 (4, 9), and the quartiles of the Western medicine group were 12 (9.25, 15.75). The difference between the two groups after treatment was statistically significant (P=0.001, P≤0.05). The individual before-and-after comparisons of the traditional Chinese medicine group and the Western medicine group were all p<0.001, indicating statistical significance. This suggests that both treatment methods have certain efficacy, and the treatment effect of the traditional Chinese medicine group is superior to that of the Western medicine group.

[0064] 3. Individual comparisons (the observation group was the traditional Chinese medicine group, and the control group was the Western medicine group).

[0065] 3.1 Abdominal pain.

[0066] .

[0067] Twenty patients in both the observation and control groups experienced abdominal pain. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median abdominal pain score before treatment was 4.00 (2.00, 4.00), and the median abdominal pain score after treatment was 0.00 (0.00, 2.00), with a median difference of 2.00 (2.00, 4.00). In the control group, the median abdominal pain score before treatment was 4.00 (2.00, 4.00), and the median abdominal pain score after treatment was 2.00 (2.00, 2.00), with a median difference of 1.50 (1.00, 2.00). The differences before and after treatment were statistically significant between the two groups (z=-2.168, P=0.03).

[0068] 3.2 Frequency of bowel movements.

[0069] .

[0070] Twenty patients in both the observation and control groups developed diarrhea. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median diarrhea score before treatment was 4.00 (4.00, 4.00), and the median diarrhea score after treatment was 2.00 (0.00, 2.00), with a median difference of 2.00 (0.00, 4.00). In the control group, the median diarrhea score before treatment was 4.00 (4.00, 4.00), and the median diarrhea score after treatment was 2.00 (2.00, 4.00), with a median difference of 1.50 (1.00, 2.00). There was no statistically significant difference in the differences before and after treatment between the two groups (z=-0.844, P=0.399).

[0071] 3.3 Rectal bleeding.

[0072] .

[0073] Twenty patients in both the observation and control groups experienced rectal bleeding. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median rectal bleeding score before treatment was 3.00 (2.00, 4.00), and the median score after treatment was 0.00 (0.00, 2.00), with a median difference of 2.00 (0.50, 2.00). In the control group, the median rectal bleeding score before treatment was 4.00 (2.50, 4.00), and the median score after treatment was 2.00 (2.00, 3.50), with a median difference of 1.50 (1.00, 2.00). There was no statistically significant difference in the differences before and after treatment between the two groups (z=-0.683, P=0.494).

[0074] 3.4 Tenesmus.

[0075] .

[0076] Twenty patients in the observation group and 20 patients in the control group experienced tenesmus. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median tenesmus score before treatment was 4.00 (2.00, 4.00), and the median tenesmus score after treatment was 0.00 (0.00, 2.00), with a median difference of 2.00 (0.00, 3.00). In the control group, the median tenesmus score before treatment was 2.00 (2.00, 4.00), and the median tenesmus score after treatment was 2.00 (0.00, 2.00), with a median difference of 1.50 (1.00, 2.00). The differences before and after treatment were statistically significant between the two groups (z=-2.292, P=0.022).

[0077] 3.5 Abdominal distension.

[0078] .

[0079] Twenty patients in both the observation and control groups experienced abdominal distension. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median abdominal distension score before treatment was 2.50 (2.00, 3.00), and the median score after treatment was 1.00 (0.00, 1.00), with a median difference of 1.00 (1.00, 2.00). In the control group, the median abdominal distension score before treatment was 2.00 (2.00, 3.00), and the median score after treatment was 2.00 (1.00, 2.00), with a median difference of 1.50 (1.00, 2.00). There was no statistically significant difference in the differences before and after treatment between the two groups (z=-2.255, P=0.24).

[0080] 3.6 Burning sensation in the anus.

[0081] .

[0082] Fifteen patients in both the observation and control groups experienced anal burning. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median anal burning score before treatment was 1.00 (1.00, 2.00), and the median score after treatment was 0.00 (0.00, 1.00), with a median difference of 0.00 (0.00, 1.00). In the control group, the median anal burning score before treatment was 1.00 (1.00, 2.00), and the median score after treatment was 1.00 (1.00, 1.00), with a median difference of 1.50 (1.00, 2.00). The differences before and after treatment were statistically significant between the two groups (z=-2.427, P=0.015).

[0083] 3.7 Hematuria.

[0084] .

[0085] Twenty cases of hematuria occurred in both the observation group and the control group. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median hematuria score before treatment was 2.00 (2.00, 2.00), and the median hematuria score after treatment was 1.00 (1.00, 1.00), with a median difference of 1.00 (0.00, 1.00). In the control group, the median hematuria score before treatment was 2.00 (1.00, 2.00), and the median hematuria score after treatment was 1.00 (1.00, 2.00), with a median difference of 1.50 (1.00, 2.00). The differences before and after treatment were statistically significant between the two groups (z = -2.401, P = 0.016).

[0086] 3.8 Dry mouth.

[0087] .

[0088] Sixteen patients in the observation group and nineteen patients in the control group experienced dry mouth. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median dry mouth score before treatment was 1.00 (1.00, 1.00), and the median dry mouth score after treatment was 0.00 (0.00, 1.00), with a median difference of 0.00 (0.00, 1.00). In the control group, the median dry mouth score before treatment was 1.00 (1.00, 1.00), and the median dry mouth score after treatment was 1.00 (1.00, 1.00), with a median difference of 2.00 (1.00, 2.00). The differences before and after treatment were statistically significant between the two groups (z=-2.572, P=0.01).

[0089] 3.9 Bitter taste in the mouth.

[0090] .

[0091] Eleven patients in the observation group and ten patients in the control group experienced a bitter taste in their mouths. Since the data did not conform to normality, a rank-sum test was used. In the observation group, the median bitter taste score before treatment was 1.00 (1.00, 1.00), and the median bitter taste score after treatment was 0.00 (0.00, 1.00), with a median difference of 0.00 (0.00, 1.00). In the control group, the median bitter taste score before treatment was 1.00 (1.00, 1.00), and the median bitter taste score after treatment was 1.00 (1.00, 1.00), with a median difference of 1.00 (1.00, 2.00). There was no statistically significant difference in the differences before and after treatment between the two groups (z=-2.835, P=0.005).

[0092] 3.10 Comparison of effectiveness rates for individual symptoms; the statistical results are shown in the table below.

[0093] .

[0094] Conclusion: The overall effective rate of treatment in the traditional Chinese medicine group was 95%, while the overall effective rate in the Western medicine group was 75%. For patients with diarrhea, the effective rate was 65% in the observation group and 50% in the control group; for patients with bloody stools, the effective rate was 80% in the experimental group and 70% in the control group; for patients with abdominal pain, the effective rate was 90% in the observation group and 85% in the control group; for patients with tenesmus, the effective rate was 90% in the observation group and 60% in the control group; for patients with anal burning sensation, the effective rate was 66.67% in the observation group and 20% in the control group; for patients with abdominal distension, the effective rate was 85% in the observation group and 70% in the control group; for patients with dark urine, the effective rate was 80% in the observation group and 40% in the control group; for patients with dry mouth, the effective rate was 62.5% in the observation group and 21.1% in the control group; and for patients with bitter taste in the mouth, the effective rate was 72.7% in the experimental group and 10% in the control group. The traditional Chinese medicine group was significantly superior to the Western medicine group.

[0095] Example 3. Typical Case.

[0096] Ms. Zhang, 45 years old, presented to the outpatient clinic on October 24, 2022, with a 4-year history of recurrent mucus and bloody stools, which had worsened in the past month. Symptoms included: mucus and bloody stools, occurring more than 10 times daily, accompanied by tenesmus, borborygmus, poor appetite, fatigue, poor sleep, and no fever. Her tongue was pale with a white coating, and her pulse was thready and weak.

[0097] The colonoscopy report from another hospital indicated continuous congestion, edema, and ulceration in the hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, and rectum. The patient was treated with an oral Chinese herbal decoction (specific dosage of the herbs: Astragalus membranaceus 30g, Sargentodoxa cuneata 20g, Coix lacryma-jobi 30g, Agrimonia pilosa 50g, Sanguisorba officinalis charcoal 20g, Sepia esculenta 20g, Bletilla striata 6g, Panax notoginseng powder 3g, Fagopyrum dibotrys 30g, Benincasa hispida seed 20g, Alpinia oxyphylla 30g, Atractylodes lancea (fried) 30g, Gleditsia sinensis thorns 15g, Notopterygium incisum 6g, Angelica pubescens 6g; preparation method as described in Example 1). The diarrhea, mucoid bloody stools, and abdominal pain disappeared. A follow-up colonoscopy after 8 weeks of treatment showed no abnormalities in the entire colon and rectum. The patient entered remission.

[0098] The above description is merely a preferred embodiment of the present invention and is not intended to limit the patent scope of the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating ulcerative colitis with damp-heat syndrome of the large intestine, characterized in that, The raw materials of the composition are: Astragalus membranaceus 30-100g, Sargentodoxa cuneata 20-30g, Coix lacryma-jobi 20-30g, Agrimonia pilosa 30-100g, Sanguisorba officinalis charcoal 15-30g, Cuttlebone 10-20g, Bletilla striata 3-6g, Panax notoginseng powder 3-6g, Fagopyrum dibotrys 20-30g, Benincasa hispida seeds 15-30g, Alpinia oxyphylla 20-45g, Atractylodes lancea (fried) 20-30g, Gleditsia sinensis thorns 10-20g, Notopterygium incisum 5-10g, Angelica pubescens 5-10g.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials of the composition are: Astragalus membranaceus 30g, Sargentodoxa cuneata 20g, Coix lacryma-jobi 30g, Agrimonia pilosa 50g, Sanguisorba officinalis charcoal 20g, Cuttlebone 20g, Bletilla striata 6g, Panax notoginseng powder 3g, Fagopyrum dibotrys 30g, Benincasa hispida seeds 20g, Alpinia oxyphylla 30g, Atractylodes lancea (fried) 30g, Gleditsia sinensis thorns 15g, Notopterygium incisum 6g, Angelica pubescens 6g.

3. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for treating ulcerative colitis with damp-heat syndrome of the large intestine.

4. A traditional Chinese medicine oral decoction for treating ulcerative colitis with damp-heat syndrome of the large intestine, made from the traditional Chinese medicine composition described in any one of claims 1 to 2.

5. The traditional Chinese medicine decoction for treating ulcerative colitis with damp-heat syndrome of the large intestine according to claim 4, characterized in that, The preparation method is as follows: Soak the other raw materials except Panax notoginseng powder in 900mL of cold water for 30 minutes, then boil over high heat until boiling, then turn to low heat and boil for 40 minutes; boil down to 450mL of liquid, add Panax notoginseng powder, divide into 3 portions, each 150mL.