Traditional Chinese medicine composition for treating ulcerative colitis in remission stage as well as preparation method and application of traditional Chinese medicine composition
By optimizing the formulation and preparation method of traditional Chinese medicine compositions such as Euphorbia humifusa, and targeting the pathogenesis of ulcerative colitis in the remission period, the treatment principle of "strengthening the body's resistance as the main focus and clearing residual pathogens" was adopted. This solved the problem of insufficient targeting of existing compositions in the remission period and achieved efficient intestinal mucosal repair and relapse prevention effects.
Patent Information
- Application Number
- CN202511800193.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-02
- Publication Date
- 2026-01-20
AI Technical Summary
Existing Chinese herbal medicine compositions lack specificity in treating the remission phase of ulcerative colitis, making it difficult to effectively address the treatment needs of different disease stages, and conventional drug treatments have adverse reactions.
Using a combination of traditional Chinese medicines such as Euphorbia humifusa, Sanguisorba officinalis charcoal, Euryale ferox, Bletilla striata, Galla chinensis, Catechu, and pearl powder, various dosage forms are prepared through heating and reflux extraction and vacuum concentration. Targeting the pathogenesis characteristics during the remission period, the treatment principle of "strengthening the body's resistance as the main focus and clearing residual pathogens" is adopted, combined with the idea of "external treatment and internal application" to synergistically repair the intestinal mucosa and clear residual damp-heat pathogens.
It significantly improves the treatment effect of ulcerative colitis in remission, reduces adverse reactions, enhances the intestinal mucosal repair capacity, and prevents recurrence. It meets the goals of mucosal healing in modern medicine and is suitable for the pathogenesis characteristics of ulcerative colitis in remission, where damp-heat gradually recedes and spleen deficiency manifests.
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Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating ulcerative colitis in remission period and a preparation method and application thereof. BACKGROUND
[0002] Ulcerative colitis (UC for short) is a chronic intestinal inflammatory disease that mainly affects the rectum and large intestine. Disease types include initial onset and recurrence, and lesion ranges can be divided into rectal type (E1), left half colon type (E2), and extensive colon type (E3). The cause of the disease is not clear, and it may be related to environmental, genetic, intestinal microecology, and immune factors. The disease can occur at any age, but it is most common in young adults aged 20 to 49 years, and there is no significant gender difference. The mortality rate is low, but long-term illness may increase the risk of intestinal cancer.
[0003] The typical symptoms of ulcerative colitis include recurrent diarrhea and abdominal pain, and the stool is often accompanied by blood, mucus or pus, and accompanied by the abnormal feeling of "always wanting to go to the toilet but not being clean". The severity of the disease varies, with mild patients having less than 4 bowel movements per day, and severe patients having more than 10. In addition, there may also be systemic symptoms such as fever, malnutrition, and extraintestinal manifestations such as arthritis and skin erythema.
[0004] The treatment goal of ulcerative colitis is to control inflammation, relieve symptoms, prevent complications, and improve the quality of life of patients. Common treatment methods include general treatment such as adequate rest and nutritious diet, drug treatment such as aminosalicylic acid preparations, glucocorticoids, and immunosuppressants, and surgical treatment. For mild and moderate patients, drug treatment usually achieves good results; and for severe patients or patients with complications such as massive hemorrhage and intestinal perforation, emergency surgery may be required.
[0005] Ulcerative colitis has a long research history, and with the progress of medicine, the understanding of its pathogenesis and treatment methods is also continuously deepening. According to the disease condition, it can be divided into active and remission periods. In the active period, there are abdominal pain, diarrhea, mucous blood stool, and tenesmus, and mucous blood stool is the most common manifestation in the active period. Patients in the remission period have basically no symptoms, and various laboratory indicators are normal, and even colonoscopy is normal. They may also have symptoms such as abdominal pain or diarrhea, but no blood in the stool. After effective treatment in the active period, it can enter the remission period, but patients in the remission period may relapse due to infection, overwork, improper diet, etc., and return to the active period. Since ulcerative colitis is difficult to cure and prone to multiple relapses, maintenance medication is also required in the remission period.
[0006] The current drug treatment method has adverse reactions, and existing studies show that Chinese medicine can treat ulcerative colitis from the aspects of deficiency, excess, cold and heat, and at the same time, acupuncture treatment is used, which significantly improves the treatment effect of patients and reduces the incidence of adverse reactions, greatly improves the quality of life of patients and long-term prognosis. There are many Chinese medicine compositions for treating ulcerative colitis, but Chinese medicine advocates treatment based on syndrome differentiation, and the principle of "formula from method, method from syndrome", according to the treatment principle of each composition, different components of monarch, minister, assistant and messenger are composed, different pathological mechanisms are targeted, different directions are focused on, and different effects are obtained.
[0007] The team has long focused on the treatment of chronic ulcerative colitis and has carried out a lot of systematic work. Among them, the technical solution of patent No. CN102940779A is an experienced prescription formed by clinical experts in the team based on years of clinical experience. The patent discloses a pharmaceutical composition for treating chronic ulcerative colitis and a preparation method thereof. The pharmaceutical composition formula is: 90-150 parts of earthbound morningglory, 10-60 parts of ganoderma lucidum, 60-120 parts of sanguisorba officinalis, 50-150 parts of purple pearl leaf, 20-100 parts of sophora flavescens, 20-80 parts of aspidistra elatior, 50-110 parts of madder, 10-70 parts of poria cocos, 10-70 parts of gordon euryale, 10-80 parts of biota orientalis, 10-70 parts of concha arcae, 5-40 parts of gallnut, 10-70 parts of bletilla striata, 0-40 parts of catechu, and 0-40 parts of panax notoginseng. After years of clinical application observation by clinical experts in the team, it is found that the above experienced prescription has certain therapeutic effect on chronic ulcerative colitis, but in the treatment of different stages of the disease, it does not have a significant advantage. In order to solve this problem, the team optimizes the original prescription and obtains a new formula composed of earthbound morningglory, ganoderma lucidum, poria cocos, aspidistra elatior, sanguisorba officinalis, sophora flavescens, bletilla striata and panax notoginseng. However, further research and practice show that the new formula still has room for improvement in the targeted treatment effect of chronic ulcerative colitis in the active stage and the remission stage, and has not fully met the needs of clinical precise treatment of different stages. SUMMARY
[0008] The present application provides a kind of traditional Chinese medicine composition for treating ulcerative colitis remission period and preparation method and application thereof to solve the problems in prior art.
[0009] The technical solutions adopted by the present application to solve the above problems are as follows: In a first aspect, the present application provides a traditional Chinese medicine composition for treating remission stage of ulcerative colitis, which is composed of the following raw materials in the weight ratio: 5-35 parts of Euphorbia humifusa, 3-12 parts of Sanguisorba officinalis char, 3-12 parts of Euryale ferox, 1-6 parts of Bletilla striata, 0.5-5 parts of Rhus galla, 0.06-0.3 parts of Catechu, and 0.02-0.12 parts of Pearl powder.
[0010] As some preferred embodiments of the present application, the traditional Chinese medicine composition is composed of the following raw materials in the weight ratio: 15-30 parts of Euphorbia humifusa, 6-10 parts of Sanguisorba officinalis char, 6-9 parts of Euryale ferox, 2-5 parts of Bletilla striata, 1-4 parts of Rhus galla, 0.09-0.15 parts of Catechu, and 0.04-0.09 parts of Pearl powder.
[0011] As some preferred embodiments of the present application, the traditional Chinese medicine composition is composed of the following raw materials in the weight ratio: Prescription one: 30 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis char, 7 parts of Euryale ferox, 3 parts of Bletilla striata, 2 parts of Rhus galla, 0.08 parts of Catechu, and 0.08 parts of Pearl powder; Prescription two: 25 parts of Euphorbia humifusa, 7 parts of Sanguisorba officinalis char, 6 parts of Euryale ferox, 2 parts of Bletilla striata, 3 parts of Rhus galla, 0.09 parts of Catechu, and 0.05 parts of Pearl powder; Prescription three: 20 parts of Euphorbia humifusa, 10 parts of Sanguisorba officinalis char, 8 parts of Euryale ferox, 5 parts of Bletilla striata, 4 parts of Rhus galla, 0.1 parts of Catechu, and 0.09 parts of Pearl powder; Prescription four: 15 parts of Euphorbia humifusa, 5 parts of Sanguisorba officinalis char, 9 parts of Euryale ferox, 2 parts of Bletilla striata, 2 parts of Rhus galla, 0.12 parts of Catechu, and 0.06 parts of Pearl powder; Prescription five: 18 parts of Euphorbia humifusa, 6 parts of Sanguisorba officinalis char, 6 parts of Euryale ferox, 2 parts of Bletilla striata, 2 parts of Rhus galla, 0.15 parts of Catechu, and 0.07 parts of Pearl powder; Prescription six: 15 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis char, 8 parts of Euryale ferox, 4 parts of Bletilla striata, 1 part of Rhus galla, 0.09 parts of Catechu, and 0.04 parts of Pearl powder.
[0012] In a second aspect, the present application provides a preparation method of the traditional Chinese medicine composition for treating remission stage of ulcerative colitis, which comprises the following steps: weighing the raw materials according to the ratio, adding 6-14 times of the amount of water or 50%-90% ethanol of the raw drug, extracting by heating reflux for 0.5-5 hours, extracting 1-3 times, filtering, combining the extraction liquid, concentrating under reduced pressure at 40-90°C, and drying to obtain the traditional Chinese medicine composition.
[0013] As some preferred embodiments of the present application, the preparation method comprises the following steps: S1: weighing the raw materials according to the ratio for standby; S2: adding 6-14 times of water or 50%-90% ethanol to the Euphorbia humifusa, Radix Toxicodendri, Euryale ferox, and pearl powder, and extracting by heating reflux for 0.5-5 hours, extracting 1-3 times, filtering, combining the extract, and concentrating at 40-90 DEG C under reduced pressure; S3: adding 6-14 times of water or 50%-90% ethanol to the Bletilla striata, Chinese gall, and Uncaria, and extracting by heating reflux for 0.5-5 hours, extracting 1-3 times, filtering, combining the extract, and concentrating at 40-90 DEG C under reduced pressure; S3: combining the concentrated liquids obtained in steps S1 and S2, and drying to obtain the product.
[0014] As some preferred embodiments of the present application, step S2 is adding 6-14 times of water to the Euphorbia humifusa, Radix Toxicodendri, Euryale ferox, and pearl powder, and extracting by heating reflux for 0.5-5 hours, filtering, adding 6-14 times of 50%-90% ethanol to the residue, extracting by heating reflux for 0.5-5 hours, filtering, combining the extract, and concentrating at 40-90 DEG C under reduced pressure to a density of 1.01-1.20.
[0015] As some preferred embodiments of the present application, step S3 is adding 6-14 times of 50%-90% ethanol to the Bletilla striata, Chinese gall, and Uncaria, and extracting by heating reflux for 0.5-5 hours, filtering, adding 6-14 times of water to the residue, extracting by heating reflux for 0.5-5 hours, filtering, combining the extract, and concentrating at 40-90 DEG C under reduced pressure to a density of 1.01-1.20.
[0016] In a third aspect, the present application provides a preparation for treating remission of ulcerative colitis, which comprises the traditional Chinese medicine composition for treating remission of ulcerative colitis and at least one excipient.
[0017] The preparation is a tablet, a capsule, a granule, a pill, a mixture, a syrup, a decoction, a powder, a gel, a spray, or an injection.
[0018] In a fourth aspect, the present application provides use of the above traditional Chinese medicine composition in the preparation of a medicament for treating patients with diarrhea-dampness accumulation due to spleen deficiency.
[0019] The composition of the present application is based on the essence of the remission period of ulcerative colitis, that is, "main deficiency and incomplete elimination of excess". That is, the evil of damp-heat and blood stasis is reduced, but the vital qi is damaged, and the remaining evil is not completely eliminated. According to this pathogenesis, the research team has repeatedly refined the medicinal ingredients, and adopted the treatment principle of "mainly supporting the healthy qi, and clearing the remaining evil", that is, focusing on invigorating the spleen and replenishing qi, supplemented by clearing heat and resolving toxins, promoting blood circulation and removing blood stasis, etc., to consolidate the curative effect and prevent recurrence. The composition of the present application takes Rubus corchorifolius L. as the monarch drug, which can target the key contradiction of the remission period of ulcerative colitis, attack the core of the pathogenesis, and eliminate the residual damp-heat evil in the intestines. At the same time, it breaks through the conventional method of using whitehead, Coptis, Cortex Phellodendri, and Cortex Fraxini as the monarch drug for clearing heat and resolving toxins, and also conforms to modern pharmacological research. Euryale ferox Salisb and Gallic acid are used as the ministerial drug, and the deficiency of spleen qi is the most common core pathogenesis in the remission period. The combination of the two can not only enhance the ability of astringing intestines and stopping diarrhea, but also can remove dampness and astringe sores, and promote wound healing. The combination of Sanguisorba officinalis L., Bletilla striata, Camellia sinensis, and pearl powder can target the core goal of intestinal mucosa repair in the remission period, and synergistically enhance the ability of protecting and repairing intestinal mucosa. Here, "external treatment and internal use" is used to achieve better results in the treatment of colonic ulcers. The whole prescription is novel in idea, perfectly combines traditional Chinese medicine theory with modern pharmacology, and provides a new application idea for the treatment of ulcerative colitis in the remission period. In addition, Sanguisorba officinalis L. and Bletilla striata are used together, and the two drugs can jointly assist the monarch drug to strengthen the hemostatic effect from the aspects of cooling blood and astringing. Euryale ferox Salisb is used as the ministerial drug to guide the action of various drugs to the middle-jiao spleen and stomach, and directly to the disease site, while regulating the medicinal properties, and preventing the damage of Rubus corchorifolius L. and Sanguisorba officinalis L. to the spleen and stomach yang qi. The combination of various drugs takes into account the elimination of evil and the tonification of deficiency, clears the remaining heat, removes blood stasis, and invigorates the spleen and consolidates the root. The combination of dynamic and static promotes blood circulation and prevents blood stasis, and astringes to prevent the consumption of healthy qi. The combination of multiple medicinal ingredients astringes sores and promotes tissue regeneration, and directly targets the core goal of ulcer healing. At the same time, the amount of the drug is precise, the monarch drug is used in large amount to dominate the clearing of heat and blood, and the repair drugs such as Camellia sinensis and pearl powder are used in small amount and are highly efficient, which avoids the excessive use of the drug. The whole prescription is based on the treatment idea of "clearing the remaining evil without damaging the healthy qi, and tonifying the spleen without assisting the evil" in the remission period, and has clear structure and level, which not only conforms to the idea of Chinese medicine syndrome differentiation and treatment, but also conforms to the treatment goal of modern medicine mucosa healing, and is suitable for the pathogenesis characteristics of ulcerative colitis in the remission period, that is, the gradual reduction of damp-heat and the exposure of spleen deficiency.
[0020] The beneficial effects of the composition of the present application are as follows: The composition of the present application is based on the core pathogenesis of ulcerative colitis in the remission period, that is, "main deficiency and incomplete elimination of excess", and is formulated according to the principle of "mainly supporting the healthy qi, and clearing the remaining evil". The monarch drug breaks through the traditional and conventional method, and innovatively adopts the idea of "external treatment and internal use". The combination of various drugs takes into account the elimination of evil and the tonification of deficiency, the combination of dynamic and static, the precise amount and effect, and the mild medicinal properties, which can not only astringe sores, promote tissue regeneration, and repair intestinal mucosa to meet the modern mucosa healing goal, but also clear the remaining evil, invigorate the spleen, and consolidate the root to consolidate the curative effect and prevent recurrence. The prescription is scientific and reasonable, and the animal efficacy test and clinical application verify the exact curative effect, which provides a new and effective idea for the traditional Chinese medicine treatment of the disease. BRIEF DESCRIPTION OF DRAWINGS
[0021] Figure 1 is a mouse weight chart in the effect example of the present application; Figure 2 is a typical mouse pathological chart of the present application; the left column is 40 times of a microscope, and the right column is 200 times of a microscope. DETAILED DESCRIPTION
[0022] In order to make the objects, technical solutions and advantages of the present application clearer, the present application will be clearly and completely described below in conjunction with specific examples.
[0023] Various terms and phrases used in the present application have the general meanings known to those skilled in the art, even so, the present application still wishes to make more detailed explanations and interpretations of these terms and phrases here, and the terms and phrases mentioned herein are subject to the meanings expressed in the present application if they are inconsistent with the known meanings.
[0024] In the present application, the term "Euphorbia humifusa", whose Latin name is Euphorbia humifusa, Euphorbia Humifusae Herb is the dry whole plant of Euphorbia humifusa. Euphorbia humifusa Willd. or Euphorbia humifusa. Euphorbia maculata L. is collected in summer and autumn, impurities are removed, and dried.
[0025] In the present application, the term "Ulmus macrocarpa", whose Latin name is Ulmus macrocarpa, Carbonized Sanguisorba Root is the dry root of Ulmus macrocarpa. Sanguisorba officinalis L. or Ulmus macrocarpa. Bloodroot officinalis L. var. longifolia (Bert.) Yüet Li The latter is commonly known as "Mian Ulmus". It is dug up when sprouting in spring or after the plant withers in autumn, the rootlets are removed, washed, dried, or fresh sliced, dried, and processed into charred preparation.
[0026] In the present application, the term "Gualou", whose Latin name is Gualou, Euryales Seed is the dry mature seed kernel of Gualou. Euryale ferocious Salisb. The mature fruits are collected in late autumn and early winter, the pericarp is removed, the seeds are taken out, washed, and the hard shell (exotesta) is removed, and dried.
[0027] In the present application, the term "Bletilla striata", whose Latin name is Bletilla striata, Rhizoma of Bletillae, is the dry tuber of Bletilla striata. Bletilla striata (Thunb.) Reichb.f. It is dug up in summer and autumn, the rootlets are removed, washed, boiled or steamed in boiling water until there is no white heart, dried until half dry, the outer skin is removed, and dried.
[0028] In the present application, the term "Gallnut", whose Latin name is Gallnut, Chinese Galla is the insect gall on the leaves of Rhus chinensis, Rhus chinensis Mill. Rhus potaninii, Rhus potaninii Maxim Rhus punjabensis. Rhus punjabensis Stew var. Chinese (Diels) Rehd. and Wils. The insect gall is mainly composed of gallnut aphid. Melaphis chinensis (Bell) Baker It is formed by parasitism. Harvest in autumn, briefly boil or steam in boiling water until the surface turns gray to kill the aphids, then remove and dry.
[0029] In this invention, the term "catechu" is its Latin name. Catechu It is a legume plant called catechu. Acacia catechu (Lf) Willd. The bark is removed from the branches and the dried branches are then boiled to make an extract. The branches and branches are harvested in winter, the outer bark is removed, they are chopped into large pieces, boiled in water, concentrated, and then dried.
[0030] In this invention, the term "pearl powder" has the Latin name... Pearl Dust, It is the pearl oyster of the pearl family Pinctada maxima. Pteria martensii (Dunker) Triangular sail mussel (a species of mussel) Hyriopsis cumingii (Lea) Or the pleated crown mussel Cristaria plicata (Leach) Pearls formed by stimulation of bivalves. Removed from the body, washed, dried, ground, and made into the finest powder using the water-milling method (Pharmacopoeia General Chapter 0213).
[0031] Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc. used in the embodiments of this invention are obtained through conventional commercial channels.
[0032] Example 1 A traditional Chinese medicine composition for treating the remission phase of ulcerative colitis, comprising the following ingredients by weight: 30 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis charcoal, 7 parts of Euryale ferox, 3 parts of Bletilla striata, 2 parts of Galla chinensis, 0.08 parts of Catechu, and 0.08 parts of Pearl Powder.
[0033] Specific preparation steps: S1: Take 12 times the amount of raw herbs of Euphorbia humifusa, charred Sanguisorba officinalis, Euryale ferox, and pearl powder, add water, reflux for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs of 80% ethanol to the residue, reflux for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08 for later use. S2: Take Bletilla striata, Galla chinensis, and Catechu and add 12 times the amount of raw herbs to 80% ethanol. Reflux and extract for 2 hours. Filter and set aside the filtrate. Add 12 times the amount of raw herbs to the residue and reflux and extract for 2 hours. Filter and combine the two extracts. Concentrate under reduced pressure at 60℃ to a density of 1.08 and set aside. S3: Combine the concentrates from steps S1 and S2, continue to concentrate to a density of 1.10, dry at 70°C, pulverize the dried paste, add excipients, and prepare capsules to obtain the invention composition 1.
[0034] Example 2 A traditional Chinese medicine composition for treating the remission phase of ulcerative colitis, comprising, by weight, 25 parts of Euphorbia humifusa, 7 parts of Sanguisorba officinalis charcoal, 6 parts of Euryale ferox, 2 parts of Bletilla striata, 3 parts of Galla chinensis, 0.09 parts of Catechu, and 0.05 parts of Pearl Powder.
[0035] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba carbon, Euryale ferox, pearl powder and 12 times the amount of water, reflux extraction for 2 hours, filter, filter for standby, the residue is added to 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two times of extraction liquid, concentrated to density 1.08 at 60℃ under reduced pressure, standby; S2: Take white and black, gallnut, and tea, add 12 times the amount of 80% ethanol, reflux extraction for 2 hours, filter, filter for standby, the residue is added to 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two times of extraction liquid, concentrated to density 1.08 at 60℃ under reduced pressure, combine the concentrated liquid of step S1, continue to concentrate to density 1.10, standby; S3: Combine the concentrated liquid of step S1 and S2, continue to concentrate to density 1.10, dry at 70℃, after crushing the dry extract, add 10% malt dextrin to adjust the dosage, prepare into granules, the invention composition 2 is obtained.
[0036] Example 3 A traditional Chinese medicine composition for treating ulcerative colitis remission, the raw materials include Euphorbia humifusa 20 parts, Sanguisorba carbon 10 parts, Euryale ferox 8 parts, white and black 5 parts, gallnut 4 parts, tea 0.1 parts, pearl powder 0.09 parts.
[0037] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba carbon, Euryale ferox, white and black, gallnut, tea, and pearl powder and 12 times the amount of water, reflux extraction for 2 hours, filter, filter for standby, the residue is added to 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two times of extraction liquid, concentrated to density 1.08 at 60℃ under reduced pressure, standby; S2: Dry the concentrated liquid at 60℃, after crushing the dry extract, add excipients, prepare into capsules, the invention composition 3 is obtained.
[0038] Example 4 A traditional Chinese medicine composition for treating ulcerative colitis remission, the raw materials include Euphorbia humifusa 15 parts, Sanguisorba carbon 5 parts, Euryale ferox 9 parts, white and black 2 parts, gallnut 2 parts, tea 0.12 parts, pearl powder 0.06 parts.
[0039] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba carbon, Euryale ferox, white and black, gallnut, tea, and pearl powder and 12 times the amount of water, reflux extraction for 2 hours, filter, filter for standby, the residue is added to 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two times of extraction liquid, concentrated to density 1.08 at 60℃ under reduced pressure, standby; S2: Dry the concentrate at 60°C, pulverize the dried paste, add 10% maltodextrin to adjust the dosage, and prepare granules to obtain the invention composition 4.
[0040] Example 5 A traditional Chinese medicine composition for treating the remission phase of ulcerative colitis, comprising the following ingredients by weight: 18 parts of Euphorbia humifusa, 6 parts of Sanguisorba officinalis charcoal, 6 parts of Euryale ferox, 2 parts of Bletilla striata, 2 parts of Galla chinensis, 0.15 parts of Catechu, and 0.07 parts of Pearl Powder.
[0041] Specific preparation steps: S1: Take 10 times the amount of raw herbs of Euphorbia humifusa, Sanguisorba officinalis charcoal, Euryale ferox, and pearl powder, add water, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs of 60% ethanol to the residue, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.06 for later use. S2: Take Bletilla striata, Galla chinensis, and Catechu and add 10 times the amount of raw herbs to 60% ethanol. Reflux and extract for 1.5 hours. Filter and set aside the filtrate. Add 10 times the amount of raw herbs to the residue and reflux and extract for 1.5 hours. Filter and combine the two extracts. Concentrate under reduced pressure at 70℃ to a density of 1.06. S3: Combine the concentrates from steps S1 and S2, and continue to concentrate to 1.09. Dry the concentrate at 60°C, pulverize the dried paste, add 10% maltodextrin, granulate, and prepare into capsules to obtain the invention composition 5.
[0042] Example 6 A traditional Chinese medicine composition for treating the remission phase of ulcerative colitis, comprising the following ingredients by weight: 15 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis charcoal, 8 parts of Euryale ferox, 4 parts of Bletilla striata, 1 part of Galla chinensis, 0.09 parts of Catechu, and 0.04 parts of Pearl Powder.
[0043] Specific preparation steps: S1: Take 10 times the amount of raw herbs of Euphorbia humifusa, charred Sanguisorba officinalis, Euryale ferox, and pearl powder, add water, reflux for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs of 60% ethanol to the residue, reflux for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.06 for later use. S2: Take Bletilla striata, Galla chinensis, and Catechu and add 10 times the amount of raw herbs to 60% ethanol. Reflux and extract for 1.5 hours. Filter and set aside the filtrate. Add 10 times the amount of raw herbs to the residue and reflux and extract for 1.5 hours. Filter and combine the two extracts. Concentrate under reduced pressure at 70℃ to a density of 1.06. S3: Combine the concentrates from steps S1 and S2, and continue to concentrate to 1.09. Dry the concentrate at 60°C. After pulverizing the dried paste, add 10% maltodextrin to adjust the dosage and prepare granules to obtain the invention composition 6.
[0044] Comparative Example 1 A traditional Chinese medicine composition for treating ulcerative colitis, raw materials of which include, by weight, 100 parts of Euphorbia humifusa, 120 parts of Ganoderma lucidum, 80 parts of Hippophae rhamnoides, 70 parts of Callicarpa japonica, 50 parts of Sophora flavescens, 30 parts of Agrimonia pilosa, 60 parts of Rubia cordifolia, 30 parts of Poria cocos, 30 parts of Euryale ferox, 20 parts of Biota orientalis, 30 parts of Sophora japonica, 40 parts of Arca inflata, 20 parts of Rhus succedaneum, 30 parts of Camellia japonica, 20 parts of Uncaria sinensis, and 15 parts of Panax notoginseng.
[0045] Specific preparation steps are as follows: ①Take Euphorbia humifusa, Hippophae rhamnoides, Sophora japonica, Ganoderma lucidum, Sophora flavescens, Poria cocos, Euryale ferox, Arca inflata, Rhus succedaneum, and Uncaria sinensis, and add 12 times the amount of water of crude drugs, reflux extraction for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of 80% ethanol of crude drugs to the residue, reflux extraction for 2 hours, filter, and combine the two extraction solutions. Concentrate at 60°C under reduced pressure to a density of 1.08, and reserve. ②Take Biota orientalis, Callicarpa japonica, Rubia cordifolia, Camellia japonica, Uncaria sinensis, and Agrimonia pilosa, and add 12 times the amount of 80% ethanol of crude drugs, reflux extraction for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of water of crude drugs to the residue, reflux extraction for 2 hours, filter, and combine the two extraction solutions. Concentrate at 60°C under reduced pressure to a density of 1.08. Combine the concentrated solution of step ①, and continue to concentrate to a density of 1.10, and reserve. ③Dry the concentrated solution of step ② at 70°C, crush the dry extract, add 10% malt dextrin to adjust the dosage, and prepare granules. Comparative composition 1 is obtained.
[0046] Comparative Example 2 A traditional Chinese medicine composition for treating ulcerative colitis, raw materials of which include, by weight, 25 parts of Euphorbia humifusa, 7 parts of Hippophae rhamnoides carbon, 6 parts of Sophora japonica, 8 parts of Rubia cordifolia, 6 parts of Biota orientalis, 2 parts of Camellia japonica, 3 parts of Uncaria sinensis, 3 parts of Agrimonia pilosa, and 8 parts of Areca catechu carbon.
[0047] Specific preparation steps are as follows: ①Take Euphorbia humifusa, Hippophae rhamnoides carbon, Sophora japonica, and Areca catechu carbon, and add 12 times the amount of water of crude drugs, reflux extraction for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of 80% ethanol of crude drugs to the residue, reflux extraction for 2 hours, filter, and combine the two extraction solutions. Concentrate at 60°C under reduced pressure to a density of 1.08, and reserve. ②Take Biota orientalis, Rubia cordifolia, Camellia japonica, Uncaria sinensis, and Agrimonia pilosa, and add 12 times the amount of 80% ethanol of crude drugs, reflux extraction for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of water of crude drugs to the residue, reflux extraction for 2 hours, filter, and combine the two extraction solutions. Concentrate at 60°C under reduced pressure to a density of 1.08. Combine the concentrated solution of step ①, and continue to concentrate to a density of 1.10, and reserve. ③Dry the concentrated solution of step ② at 70°C, crush the dry extract, add 10% malt dextrin to adjust the dosage, and prepare granules. Comparative composition 2 is obtained.
[0048] Comparative Example 3 A traditional Chinese medicine composition for treating ulcerative colitis, the raw materials of which include, in parts by weight, 23 parts of Euphorbia humifusa, 10 parts of Ganoderma lucidum, 8 parts of Poria cocos, 6 parts of Agrimonia eupatoria, 6 parts of Radix Sophorae Flavescentis, 5 parts of Sophora flavescens, 2 parts of Bletilla striata, and 4 parts of Panax notoginseng.
[0049] Specific preparation steps are as follows: ①Take Euphorbia humifusa, Radix Sophorae Flavescentis, Sophora flavescens, Poria cocos, and Ganoderma lucidum and add 12 times the amount of water of the crude drug, reflux extraction for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of 80% ethanol of the crude drug to the residue, reflux extraction for 2 hours, filter, and combine the two extraction solutions. Concentrate at 60°C under reduced pressure to a density of 1.08, and reserve. ②Take Agrimonia eupatoria, Bletilla striata, and Panax notoginseng and add 12 times the amount of 80% ethanol of the crude drug, reflux extraction for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of water of the crude drug to the residue, reflux extraction for 2 hours, filter, and combine the two extraction solutions. Concentrate at 60°C under reduced pressure to a density of 1.08. Combine the concentrated solution of step ① and continue to concentrate to a density of 1.10, and reserve. ③Dry the concentrated solution of step ② at 70°C, crush the dry extract, and add 10% malt dextrin to adjust the dosage to prepare granules. The comparative composition 3 is obtained.
[0050] Example 1 Animal efficacy test 1. Test purpose A DSS was used to construct a mouse model of ulcerative colitis to investigate the effectiveness and mechanism of different traditional Chinese medicine compositions in treating ulcerative colitis in mice.
[0051] 2. Test design 2.1 Experimental method SPF male C57BL / 6J mice, 6-8 weeks old, weighing 20±2g, were adaptively fed, and then randomly divided into a normal control group and a modeling group according to the body weight. The normal control group had 5 animals, and the modeling group had 85 animals. The normal control group was normally fed, and the modeling group was changed to 2% DSS drinking water. After 7 days of modeling, the modeling group was divided into a model control group, a positive control group, and a traditional Chinese medicine composition group according to the DAI score. The specific grouping and administration scheme are shown in Table 1.
[0052] Table 1 Information of mouse grouping 2.2 Detection index Table 2 Detection index 2.3 Statistical analysis For quantitative data, first, the data homogeneity test was conducted by Bartlett test method. If the data were homogeneous (test P≥0.05), the variance analysis test (F test) was conducted. If the result of Bartlett test was significant (p<0.05), the Kruskal-wallis test was conducted. If the result of variance analysis test was significant (p<0.05), the multiple comparison test was conducted by Dunett parameter test method. If the result of variance analysis was not significant (p≥0.05), the statistics ended. If the result of Kruskal-wallis test was significant (p<0.05), the multiple comparison test was conducted by Dunett non-parameter test method. If the result of Kruskal-wallis test was not significant, the statistics ended.
[0053] 3. Results of Experiment 3.1 Clinical Observation Under the conditions of the present experiment, all animals in each group survived until the end of the experiment. No abnormality was observed in the clinical observation of all animals in the blank control group, and the animals were in good mental state. After modeling, some animals showed reduced movement from D5, and all modeling animals showed decreased activity from D7. After administration, the animals in groups other than the blank control group showed decreased activity and movement. The feces of animals in the test product group were black.
[0054] 3.2 Modeling Results Under the conditions of the present experiment, the animals were randomly divided into a normal control group and a modeling group. The normal control group had 5 animals, and the modeling group had 85 animals. DAI scores were obtained after 7 days of modeling. The modeling group showed higher scores than the normal control group, with a significant difference (p<0.001), indicating that the modeling was successful. The DAI score results are shown in Table 3.
[0055] Table 3 DAI score table after 7 days of modeling (x±SD) Note: *** represents comparison with the normal control group p <0.001 3.3 Results of Administration Experiment 3.3.1 Body Weight Results The body weight of the blank control group was significantly higher than that of the model group after modeling, with significant difference (p<0.05, p<0.01, p<0.001). After modeling and administration, the body weight of the model control group gradually decreased. In the first week of administration: the body weight of the positive control group was significantly higher than that of the model control group after D3 (p<0.05, p<0.01, p<0.001), and there was no significant difference in the body weight between the test product groups and the model group. In the second week: the body weight of the animals in the positive control group and the test product groups (traditional Chinese medicine composition groups 1-4) tended to be stable and did not show significant decrease, and the body weight of the animals in the model control group significantly decreased. The body weight of the positive drug group was significantly higher than that of the model control group (p<0.05, p<0.01, p<0.001); the body weight of the traditional Chinese medicine composition groups 1-4 was significantly higher than that of the model control group (p<0.05, p<0.01, p<0.001). Comparison between the traditional Chinese medicine composition groups 1-4 showed that the body weight of the traditional Chinese medicine composition group 2 was always higher than that of the other three groups, and was significantly higher than that of the traditional Chinese medicine composition group 1 in D1-9 (p<0.05, p<0.01, p<0.001), and was significantly higher than that of the traditional Chinese medicine composition group 3 in D12 and D13 (p<0.05). See Figure 1 .
[0056] 3.3.2 Body weight score According to the decrease of animal body weight, the body weight score was conducted. The model control group and the normal group were significantly increased with statistical difference (p<0.001); the positive control group and the model control group were significantly different from each other starting from D10 (p<0.05), and then had extremely significant difference (p<0.001); the traditional Chinese medicine composition group 1 was significantly different from the model control group starting from D16 (p<0.01), and then had extremely significant difference (p<0.001); the traditional Chinese medicine composition group 2 was significantly different from the model control group after administration (p<0.05, p<0.001); the traditional Chinese medicine composition group 3 was significantly different from the model control group in D12 and D14 (p<0.05), and was significantly different from the model control group in D15 and D16 (p<0.01) and then had extremely significant difference (p<0.001); the traditional Chinese medicine composition group 4 was significantly different from the model control group in D14 (p<0.05), and was significantly different from the model control group in D15 and D16 (p<0.01) and then had extremely significant difference (p<0.001); see Tables 4-5.
[0057] Table 4 Body weight score table (x±SD) Note: *** represents p<0.001 compared with the normal control group; ### represents p<0.001 compared with the model control group, ## represents p<0.01 compared with the model control group, and # represents p<0.05 compared with the model control group.
[0058] Table 5 Body weight score table (x±SD) Note: *** represents p<0.001 compared with the normal control group; ### represents p<0.001 compared with the model control group, ## represents p<0.01 compared with the model control group, and # represents p<0.05 compared with the model control group.
[0059] 3.3.3 Fecal occult blood score After the modeling of the animals, fecal occult blood was obviously detected in the modeling group, and the detection score of each group before administration was higher than 1 (the coloration time index of the kit), which was significantly different from that of the blank control group (p<0.001). After grouping and administration, the occult blood of the positive control group and the test product groups (traditional Chinese medicine compositions 1-4 groups) was no longer aggravated and gradually alleviated. The occult blood of the model control group gradually aggravated over time. During the administration period: the model control group was significantly different from the normal control group (p<0.001); the positive control group was significantly different from the model control group on D10 (the third day of administration) (p<0.01), and then was extremely significantly different from the model control group (p<0.001); the traditional Chinese medicine composition 1 group was significantly different from the model control group on D9 and D10 (the second and third days of administration) (p<0.05), and then was extremely significantly different from the model control group (p<0.001); the traditional Chinese medicine composition 2 group was extremely significantly different from the model control group since D11 (the fourth day of administration) (p<0.001); the traditional Chinese medicine composition 3 group was significantly different from the model control group on D10 (the third day of administration) (p<0.05), and then was extremely significantly different from the model control group (p<0.001); and the traditional Chinese medicine composition 4 group was significantly different from the model control group on D9 and D10 (the second and third days of administration) (p<0.05), and then was extremely significantly different from the model control group (p<0.001). See Tables 6-7.
[0060] Table 6 Fecal occult blood score table (x±SD) Note: *** represents p<0.001 compared with the normal control group; ### represents p<0.001 compared with the model control group, ## represents p<0.01 compared with the model control group, and # represents p<0.05 compared with the model control group.
[0061] Table 7 Fecal occult blood score table (x±SD) Note: *** represents p<0.001 compared with the normal control group; ### represents p<0.001 compared with the model control group, ## represents p<0.01 compared with the model control group, and # represents p<0.05 compared with the model control group.
[0062] 3.3.4 Stool Viscosity Score After the animals were modeled, the stool viscosity of the animals in the modeling group increased significantly, and there was a significant difference compared with the blank control group (p<0.001). After grouping and administration, the viscosity aggravation degree of the positive control group and the test product groups (traditional Chinese medicine composition groups 1-4) was reduced. The viscosity of the model control group gradually aggravated over time. During the administration period: there was no significant difference in the viscosity increase between the model control group and the normal control group on D8, and then there was a significant difference during the test period (p<0.001); the positive control group had a significant difference compared with the model control group on D9 and D10 (the second and third days of administration) (p<0.01), and then had a very significant difference compared with the model control group (p<0.001); the traditional Chinese medicine composition 1 group had a significant difference compared with the model control group (p<0.01, p<0.001); the traditional Chinese medicine composition 2 group had a significant difference compared with the model control group from D9 to D12 (the second day to the fifth day of administration) (p<0.05), had a significant difference compared with the model control group from D13 to D14 (the sixth and seventh days of administration) (p<0.01), and then had a very significant difference compared with the model control group (p<0.001); the traditional Chinese medicine composition 3 group had a significant difference compared with the model control group on D11 and D12 (the fourth and fifth days of administration) (p<0.05), had a significant difference compared with the model control group from D13 to D14 (the sixth and seventh days of administration) (p<0.01), and then had a very significant difference compared with the model control group (p<0.001); the traditional Chinese medicine composition 4 group had a significant difference compared with the model control group from D9 to D12 (the second day to the fifth day of administration) (p<0.01), and then had a very significant difference compared with the model control group (p<0.001). See Tables 8-9.
[0063] Table 8 Viscosity Score Table (x±SD) Note: *** represents a significant difference compared with the normal control group p <0.001; ### represents a significant difference compared with the model control group p <0.001, ## represents a significant difference compared with the model control group p <0.01, # represents a significant difference compared with the model control group p <0.05.
[0064] Table 9 Viscosity Score Table (x±SD) Note: *** represents a significant difference compared with the normal control group p <0.001; ### represents a significant difference compared with the model control group p <0.001, ## represents a significant difference compared with the model control group p <0.01, # represents a significant difference compared with the model control group p<0.05.
[0065] 3.3.5 DAI score DAI numerical score was calculated according to the body weight score, occult blood score and fecal viscosity score. During the treatment: the model control group was significantly different from the normal control group (p<0.001); the positive control group was significantly different from the model control group (p<0.01, p<0.001); the traditional Chinese medicine compositions 1-4 groups were significantly different from the model control group (p<0.05, p<0.01, p<0.001); comparison between the traditional Chinese medicine compositions 1-4 groups showed that the traditional Chinese medicine compositions 2 and 4 groups were significantly lower than the traditional Chinese medicine composition 1 group (p<0.05, p<0.01, p<0.001) on D3-9, and the traditional Chinese medicine composition 2 and 4 groups were better than the traditional Chinese medicine composition 3 group in terms of score results, and the traditional Chinese medicine composition 1 group took the longest time to take effect. See Tables 10-11.
[0066] Table 10 DAI score table (x±SD) Note: *** represents p<0.001 compared with the normal control group; ### represents p<0.001 compared with the model control group, ## represents p<0.01 compared with the model control group, and # represents p<0.05 compared with the model control group.
[0067] Table 11 DAI score table (x±SD) Note: *** represents p<0.001 compared with the normal control group; ### represents p<0.001 compared with the model control group, ## represents p<0.01 compared with the model control group, and # represents p<0.05 compared with the model control group.
[0068] 3.3.6 Colon weight coefficient After modeling, the colon weight coefficient of the modeling group was significantly reduced. The model control group was significantly lower than the normal control group (p<0.05); the positive control group was significantly higher than the model control group (p<0.001); the traditional Chinese medicine composition 1 group was significantly higher than the model control group (p<0.05); the colon weight coefficient of the traditional Chinese medicine composition 2 group was higher than that of the model control group, but no difference was found (p>0.05); the colon weight coefficient of the traditional Chinese medicine composition 3 group was higher than that of the model control group, but no difference was found (p>0.05); the traditional Chinese medicine composition 4 group was significantly higher than the model control group (p<0.01). See Table 12.
[0069] Table 12 Colon weight coefficient table (x±SD) Note: * represents p < 0.05 compared with the normal control group; ### represents p < 0.001 compared with the model control group, ## represents p < 0.01 compared with the model control group, and # represents p < 0.05 compared with the model control group.
[0070] 3.3.6 Pathological results The histopathological examination showed that the intestinal tissue of the normal control group of mice had no obvious folds, the mucosal epithelium was mainly composed of columnar epithelial cells and a small amount of goblet cells, and the mucosal epithelium was complete; the intestinal glands in the lamina propria were densely arranged in long tubular shape, and the number of goblet cells was rich; the mucosal muscle layer composed of smooth muscle cells separated the intestinal glands from the submucosal layer, the submucosal layer was composed of connective tissue, and the remaining part of the intestinal wall included the muscle layer composed of smooth muscle cells and the serous layer, and no other obvious abnormalities were found. The mucosal epithelium of the intestinal tissue of the model group of mice was mainly composed of columnar epithelial cells and a small amount of goblet cells, and mucosal epithelial cell loss was visible; the intestinal glands in the lamina propria were densely arranged in long tubular shape, and the number of goblet cells was rich; the mucosal muscle layer composed of smooth muscle cells separated the intestinal glands from the submucosal layer, the submucosal layer was composed of connective tissue, and the remaining part of the intestinal wall included the muscle layer composed of smooth muscle cells and the serous layer. After administration, the positive control group and each administration group had good therapeutic effect, and the traditional Chinese medicine composition 3 was the best, as shown in Figure 2 .
[0071] 4 Discussion In clinical practice, ulcerative colitis most commonly occurs in young adults, according to statistical data in China, the peak age of onset is 20-49 years old, and there is no significant difference between men and women. The clinical manifestations of ulcerative colitis are persistent or recurrent diarrhea, mucous blood stool, abdominal pain, and tenesmus, etc. In clinical practice, it is divided into active and remission periods according to the course of the disease, and patients with severe disease may also have varying degrees of systemic symptoms including weight loss, fever, tachycardia, fatigue, and even nausea and vomiting, etc. Among them, mucous blood stool is the most common symptom of UC, and about 90% of patients are reported to have mucous blood stool. Physical examination should pay special attention to the general condition and nutritional status of the patient, and careful abdominal, perianal, perineal examination and digital rectal examination should be performed. At the same time, attention should be paid to the extraintestinal manifestations and perianal conditions of the mouth, skin, joints, eyes, etc.
[0072] The experiment successfully established a mouse model of ulcerative colitis, and compared the efficacy of active and remission periods. Under the conditions of this experiment, the traditional Chinese medicine compositions 1-4 in the test product group had good protective effect on the body weight reduction of the model mice. For this test, DAI score and pathology were two gold indicators of this model, among which DAI score could see the improvement of the drug on the body weight loss, diarrhea, mucous blood, abdominal pain and tenesmus caused by ulcerative colitis, and pathology could directly see the protection of the drug on the colon. From the two indicators to observe the effectiveness of different test products, it can be seen that the body weight and DAI score of traditional Chinese medicine composition 1 are the worst in the first 9 days, but from the 9th day, the body weight and blood stool gradually recover, and finally show good intestinal protection effect in pathology. The body weight protection effect of traditional Chinese medicine composition 2 is the best, the DAI score is significantly better than that of traditional Chinese medicine composition 4, the pathology is only second to that of No. 3, the effect is the fastest, and finally there is also a good intestinal protection effect. The body weight and DAI score of traditional Chinese medicine composition 3 are always at a medium level, but the protection effect on intestinal injury in pathology is the best. The body weight and DAI score of traditional Chinese medicine composition 4 are inferior to those of traditional Chinese medicine composition 2. According to the clinical manifestations of ulcerative colitis and the efficacy of the four drugs, the effectiveness of the drugs is traditional Chinese medicine composition 2 > traditional Chinese medicine composition 3 > traditional Chinese medicine composition 4 > traditional Chinese medicine composition 1. In the treatment of ulcerative colitis in remission period, the traditional Chinese medicine composition 3 group, that is, the composition 2 of the application, is better than the other three comparative compositions.
[0073] 5CONCLUSION The experiment successfully established a mouse model of ulcerative colitis. Under the conditions of this experiment, the traditional Chinese medicine compositions (traditional Chinese medicine compositions 1-4) in the test product group had good protective effect on the body weight reduction of the model mice, relieved the blood stool of the model mice, prevented the deterioration of the model, and had good repair effect on the intestine. Combined with body weight and pathological performance, the effectiveness of the drugs is traditional Chinese medicine composition 2 > traditional Chinese medicine composition 3 > traditional Chinese medicine composition 4 > traditional Chinese medicine composition 1. In the treatment of ulcerative colitis in remission period, the traditional Chinese medicine composition 3 group, that is, the composition 2 of the application, is better than the other three comparative compositions.
[0074] Typical cases of clinical application of the traditional Chinese medicine composition of the application: Case 1: Wang, female, 66 years old, the patient was diagnosed with ulcerative colitis for more than 7 years. More than 7 years ago, the patient had abdominal pain, diarrhea, mucous and bloody stool and other discomforts. Colonoscopy showed that the patient was diagnosed with ulcerative colitis. The symptoms were alleviated after western medicine treatment, but still occasionally attacked. Now, the patient has abdominal pain, 1-2 times of stool per day, and can eat normally. The tongue is pale red, the coating is white, and the pulse is deep and weak. It is a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the present application, twice a day, 10g each time, for 3 months. The patient's abdominal pain symptoms basically disappeared, and there were no obvious symptoms such as bloody stool and mucus. After half a year, the patient was followed up, and the patient reported that the stool quality was normal, and the abdominal pain symptoms did not recur.
[0075] Case 2: Sheng, female, 61 years old, the patient was diagnosed with ulcerative colitis for more than 1 year. More than 1 year ago, the patient had abdominal pain, diarrhea and mucous and bloody stool. Colonoscopy showed that the patient was diagnosed with ulcerative colitis. The symptoms were alleviated after oral administration of Chinese and western medicine (the specific prescription is unknown), but the patient had diarrhea, abdominal pain and other symptoms after eating cold and greasy food. The tongue is pale red, the coating is thin and white, and the pulse is thin and stringy. It is a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the present application, twice a day, 10g each time, for 2 months. The patient had no abdominal pain, diarrhea, bloody stool and mucus. After half a year, the patient was followed up, and the patient could eat normally, and there was no recurrence of the disease.
[0076] Case 3: Jia, female, 46 years old, the patient was diagnosed with chronic ulcerative colitis for 3 years. The patient had abdominal distension, diarrhea and bloody stool, mainly white mucus, at least 2 times a day, indigestion, more severe at night, accompanied by hiccups, headache, fatigue, colonoscopy showed that the patient was diagnosed with ulcerative colitis. The symptoms were basically alleviated after oral administration of mesalazine, but the patient had recurrence after being cold. The tongue is pale red, the coating is thin and white, and the pulse is thin and slow. It is a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the present application, twice a day, 10g each time, for 2 months. The patient had no abdominal distension, diarrhea, bloody stool and other discomforts. After half a year, the patient was followed up by telephone, and the patient reported that there were no discomforts after being cold, and there was no recurrence so far.
[0077] Case 4: Li, male, 45 years old, the patient was diagnosed with ulcerative colitis for more than 3 years. Three years ago, the patient had bloody stool, 3-4 times of stool per day, mixed with blood and mucus. Colonoscopy showed that the patient was diagnosed with ulcerative colitis. The patient took mesalazine and montmorillonite powder by himself, and the symptoms were occasionally attacked, especially after eating cold and greasy food. The tongue is pale, the coating is thin and white, and the pulse is deep. It is a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the present application, twice a day, 10g each time, for 2 months. The abdominal distension and intestinal sound symptoms basically disappeared. Later, the patient was followed up, and the patient had occasional attacks after being cold, tired and eating greasy food, which did not affect normal work and life.
[0078] Case 5: Guo, male, 60 years old, the patient was diagnosed with ulcerative colitis for more than 5 years. 5 years ago, the patient had abdominal pain, abdominal distension, and pus and blood stool, and other discomforts. Colonoscopy showed that the patient was diagnosed with ulcerative colitis. After treatment with western medicine (details unknown), the symptoms were relieved. The symptoms were easy to recur after improper diet. The tongue was dark red, the tongue fur was white, and the pulse was stringy and weak. It was a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the application, twice a day, 10g each time, for 4 months. The abdominal pain and abdominal distension disappeared. There was no obvious blood and mucus in the stool. The stool was basically shaped. Three months after stopping treatment, the patient's life basically returned to normal, and the disease did not recur.
[0079] Case 6: Li, female, 62 years old, the patient was diagnosed with ulcerative colitis for 20 years. 20 years ago, the patient had mucous and pus and blood stool, and diarrhea. Colonoscopy showed that the patient was diagnosed with ulcerative colitis. Intermittent combination of Chinese and Western medicine treatment (details unknown), occasionally after cooling and eating meat, the symptoms were repeated. There may be abdominal distension and mucus in the stool. The tongue was pale, the tongue fur was white, and the pulse was thin and weak. It was a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the application, twice a day, 10g each time, for 3 months. The abdominal pain and abdominal distension were significantly reduced. The blood and mucus in the stool were reduced. The stool was basically shaped. After re-examination, the patient continued to take the medicine for 2 months. The symptoms of pus and blood stool, diarrhea and other discomforts were basically controlled. Later, the patient took the medicine intermittently for maintenance treatment, which did not affect the subsequent normal life.
[0080] Case 7: Chai, male, 44 years old, the patient was diagnosed with ulcerative colitis for more than 2 months. More than 2 months ago, the patient had diarrhea after cooling. The stool was thin, the daily defecation frequency was more than 10 times, and there was a small amount of white mucus. The abdominal discomfort was relieved after defecation. The local hospital diagnosed the patient as having ulcerative colitis and gave him mesalazine tablets and traditional Chinese medicine for symptomatic treatment. The patient complained that the symptoms were significantly reduced. Sometimes after improper diet, the stool frequency increased. The tongue was dark, the tongue fur was white and greasy, and the pulse was thin and weak. It was a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient took the traditional Chinese medicine composition 2 of the application, twice a day, 10g each time, for 2 months. The stool frequency was 1-2 times a day, and there was no diarrhea, abdominal pain and other abdominal discomfort. After 3 months of follow-up, the patient's work and life basically returned to normal.
[0081] Case 8: Wang, male, 66 years old, the patient had intermittent mucous and pus and blood stool for 4 years. Four years ago, the patient had mucous and pus and blood stool after drinking. There were abdominal pain and diarrhea, 4-6 times a day. After eating, the abdominal distension was not digestible. The patient was tired and weak. Electronic colonoscopy showed that the patient was diagnosed with ulcerative colitis. The patient complained that the community gave him oral "anti-diarrhea drugs and anti-inflammatory drugs" (details unknown). The symptoms could be improved, but were easy to recur. The tongue was pale red with tooth marks on the edge. The tongue fur was white, and the pulse was stringy and weak. It was a diarrhea-spleen deficiency and dampness accumulation syndrome. The patient required traditional Chinese medicine treatment. The patient took the traditional Chinese medicine composition 2 of the application, twice a day, 10g each time, for 3 months. The patient complained that there was no obvious recurrence of the disease.
[0082] The pipe is described in detail with reference to the foregoing embodiments, and those skilled in the art can still modify the technical solutions recorded in the foregoing embodiments or make equivalent replacement for part of the technical features; and the modification or replacement does not make the essence of the corresponding technical solution deviate from the spirit and scope of the technical solutions of the embodiments of the present application.
Claims
1. A traditional Chinese medicine composition for treating ulcerative colitis remission, characterized in that, It is composed of raw materials in the following weight ratio: 5-35 parts of Euphorbia humifusa, 3-12 parts of Sanguisorba officinalis char, 3-12 parts of Euryale ferox, 1-6 parts of Bletilla striata, 0.5-5 parts of Rhus semialata, 0.06-0.3 parts of Catechu, and 0.02-0.12 parts of Pearl powder.
2. The traditional Chinese medicine composition for treating ulcerative colitis remission period according to claim 1, characterized in that, It is composed of raw materials in the following weight ratio: 15-30 parts of Euphorbia humifusa, 6-10 parts of Sanguisorba officinalis char, 6-9 parts of Euryale ferox, 2-5 parts of Bletilla striata, 1-4 parts of Rhus semialata, 0.09-0.15 parts of Catechu, and 0.04-0.09 parts of Pearl powder.
3. The traditional Chinese medicine composition for treating ulcerative colitis remission period according to claim 1, characterized in that, It is selected from any one of the following prescriptions composed of raw materials in the following weight ratio: Prescription one: Euphorbia humifusa 30 parts, Sanguisorba officinalis char 8 parts, Euryale ferox 7 parts, Bletilla striata 3 parts, Rhus semialata 2 parts, Catechu 0.08 parts, and Pearl powder 0.08 parts; Prescription two: Euphorbia humifusa 25 parts, Sanguisorba officinalis char 7 parts, Euryale ferox 6 parts, Bletilla striata 2 parts, Rhus semialata 3 parts, Catechu 0.09 parts, and Pearl powder 0.05 parts; Prescription three: Euphorbia humifusa 20 parts, Sanguisorba officinalis char 10 parts, Euryale ferox 8 parts, Bletilla striata 5 parts, Rhus semialata 4 parts, Catechu 0.1 parts, and Pearl powder 0.09 parts; Prescription four: Euphorbia humifusa 15 parts, Sanguisorba officinalis char 5 parts, Euryale ferox 9 parts, Bletilla striata 2 parts, Rhus semialata 2 parts, Catechu 0.12 parts, and Pearl powder 0.06 parts; Prescription five: Euphorbia humifusa 18 parts, Sanguisorba officinalis char 6 parts, Euryale ferox 6 parts, Bletilla striata 2 parts, Rhus semialata 2 parts, Catechu 0.15 parts, and Pearl powder 0.07 parts; Prescription six: Euphorbia humifusa 15 parts, Sanguisorba officinalis char 8 parts, Euryale ferox 8 parts, Bletilla striata 4 parts, Rhus semialata 1 part, Catechu 0.09 parts, and Pearl powder 0.04 parts.
4. A method of preparing the traditional Chinese medicine composition for treating ulcerative colitis in remission according to any one of claims 1-3, characterized in that, The raw materials are weighed according to the ratio, and water or 50%-90% ethanol in an amount of 6-14 times the amount of crude drugs is added for reflux extraction for 0.5-5 hours. The extraction is performed 1-3 times, and the filtrate is combined and concentrated under reduced pressure at 40-90°C. After drying, the product is obtained.
5. The method for preparing the traditional Chinese medicine composition for treating the remission phase of ulcerative colitis according to claim 4, characterized in that, The steps include: S1: Weigh the raw materials according to the ratio for standby; S2: Add water or 50%-90% ethanol in an amount of 6-14 times the amount of crude drugs to Euphorbia humifusa, Sanguisorba officinalis char, Euryale ferox, and Pearl powder, and perform reflux extraction for 0.5-5 hours. The extraction is performed 1-3 times, and the filtrate is combined and concentrated under reduced pressure at 40-90°C for standby; S3: Add water or 50%-90% ethanol in an amount of 6-14 times the amount of crude drugs to Bletilla striata, Rhus semialata, and Catechu, and perform reflux extraction for 0.5-5 hours. The extraction is performed 1-3 times, and the filtrate is combined and concentrated under reduced pressure at 40-90°C for standby; S3: Combine the concentrated liquids obtained in steps S1 and S2, and dry to obtain the product.
6. The method for preparing the traditional Chinese medicine composition for treating the remission phase of ulcerative colitis according to claim 5, characterized in that, Step S2 is to add water in an amount of 6-14 times the amount of crude drugs to Euphorbia humifusa, Sanguisorba officinalis char, Euryale ferox, and Pearl powder, and perform reflux extraction for 0.5-5 hours. The residue is filtered, and 50%-90% ethanol in an amount of 6-14 times the amount of crude drugs is added to the residue for reflux extraction for 0.5-5 hours. The filtrate is combined and concentrated under reduced pressure at 40-90°C to a density of 1.01-1.20 for standby.
7. The method for preparing the traditional Chinese medicine composition for treating the remission phase of ulcerative colitis according to claim 5, characterized in that, Step S3 is to add 6-14 times of the amount of raw material of Bletilla striata, Chinese gall and catechu to 50%-90% ethanol, heat reflux extraction for 0.5-5 hours, filter, then add 6-14 times of the amount of raw material of water to the residue, heat reflux extraction for 0.5-5 hours, filter, combine the extract, and concentrate under reduced pressure at 40-90℃ to a density of 1.01-1.20, ready for use.
8. A formulation for treating ulcerative colitis in remission, characterized by, The application further discloses a Chinese medicine composition for treating ulcerative colitis remission period, which comprises the Chinese medicine composition and at least one excipient.
9. The formulation for remission of ulcerative colitis according to claim 8, wherein The preparation is a tablet, a capsule, a granule, a pill, a mixture, a syrup, a decoction, a powder, a gel, a spray or an injection.
10. Use of the Chinese medicine composition for treating ulcerative colitis remission period according to any one of claims 1-3 in the preparation of a medicine for treating patients with diarrhea-spleen deficiency and dampness accumulation.
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Patent Citations
Medicine composition for treating chronic ulcerative colitis and preparation process of medicine composition
CN102940779A