Traditional Chinese medicine composition for treating active ulcerative colitis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating ulcerative colitis in an active stage as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-35 parts of humifuse euphorbia herb, 3-12 parts of carbonized sanguisorba root, 3-12 parts of sophora flower, 3-12 parts of madder, 3-12 parts of cacumen biotae, 1-6 parts of rhizoma bletillae, 0.5-5 parts of pseudo-ginseng, 2-10 parts of hairyvein agrimony and 3-12 parts of crinis trachycarpi. The traditional Chinese medicine composition has the advantages that the effects of clearing heat, cooling blood, astringing to stop bleeding, diminishing swelling and promoting tissue regeneration are achieved through synergistic interaction of the medicines, the traditional Chinese medicine composition is accurately adapted to the core pathogenesis of damp-heat accumulation, injury to blood collaterals due to heat and bleeding due to blood heat in the active period of ulcerative colitis, and the traditional Chinese medicine composition is especially suitable for active-period patients with blood, stomachache and tenesmus as main manifestations and is high in curative effect pertinence.

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 active phase 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 able to clean it up". 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 to moderate patients, drug treatment usually achieves good results; 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 phase and remission phase. The active phase is generally accompanied by abdominal pain, diarrhea, mucous blood stool, and tenesmus, and mucous blood stool is the most common manifestation in the active phase. Patients in the remission phase have no symptoms, and various laboratory indicators are normal, and even colonoscopy is normal. They may also have abdominal pain or diarrhea, but no blood in the stool. The active phase can enter the remission phase after effective treatment, but patients in the remission phase may relapse due to infection, overwork, improper diet, etc., and return to the active phase. Since ulcerative colitis is difficult to cure and prone to multiple relapses, maintenance medication is also required in the remission phase.

[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 traditional Chinese medicine compositions for treating ulcerative colitis, but Chinese medicine advocates treatment based on syndrome differentiation, and the principle of "prescription from method, method from syndrome", according to the principle, different compositions are composed of different monarchs, ministers, assistants and messengers, aiming at different pathological mechanisms and different directions, and the effects are different.

[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 based on years of clinical experience. The patent discloses a kind of drug composition for treating chronic ulcerative colitis and its preparation method, and the prescription of the drug composition is: 90-150 parts of Chinese ivy, 10-60 parts of lucid ganoderma, 60-120 parts of sanguisorba officinalis, 50-150 parts of purple pearl leaf, 20-100 parts of sophora flavescens, 20-80 parts of asparagus cochinensis, 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 the team of clinical experts, 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 show significant advantages. In order to solve this problem, the team optimizes the original prescription and obtains a new prescription composed of Chinese ivy, lucid ganoderma, poria cocos, asparagus cochinensis, sanguisorba officinalis, sophora flavescens, bletilla striata and panax notoginseng. However, further research and practice show that the new prescription still has room for improvement in the targeted treatment effect of chronic ulcerative colitis in active and remission stages, and it still cannot fully meet the needs of precise treatment of different stages of the disease in clinic. SUMMARY

[0008] The present application provides a kind of traditional Chinese medicine composition and its preparation method and application for treating ulcerative colitis active stage to solve the problems existing in prior art.

[0009] The technical solution adopted by the present application to solve the above problems is as follows: in a first aspect, the present application provides a kind of traditional Chinese medicine composition for treating ulcerative colitis active stage, which is composed of the following raw materials in weight ratio: 5-35 parts of Chinese ivy, 3-12 parts of sanguisorba officinalis carbon, 3-12 parts of sophora japonica, 3-12 parts of madder, 3-12 parts of biota orientalis, 1-6 parts of bletilla striata, 0.5-5 parts of panax notoginseng, 2-10 parts of asparagus cochinensis and 3-12 parts of palm carbon.

[0010] As some preferred embodiments of the present application, it is composed of raw materials in the following weight ratio: 15-30 parts of Euphorbia humifusa, 5-10 parts of Sanguisorba officinalis char, 6-8 parts of Sophora japonica, 6-9 parts of Rubia cordifolia, 6-9 parts of Biota orientalis, 2-5 parts of Bletilla striata, 1-4 parts of Panax notoginseng, 3-8 parts of Agrimonia pilosa, 7-11 parts of Trachycarpus fortunei char.

[0011] As some preferred embodiments of the present application, it is composed of raw materials in the following weight ratio: Prescription one: 30 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis char, 7 parts of Sophora japonica, 7 parts of Rubia cordifolia, 6 parts of Biota orientalis, 3 parts of Bletilla striata, 2 parts of Panax notoginseng, 4 parts of Agrimonia pilosa, 10 parts of Trachycarpus fortunei char.

[0012] Prescription two: 25 parts of Euphorbia humifusa, 7 parts of Sanguisorba officinalis char, 6 parts of Sophora japonica, 8 parts of Rubia cordifolia, 6 parts of Biota orientalis, 2 parts of Bletilla striata, 3 parts of Panax notoginseng, 3 parts of Agrimonia pilosa, 8 parts of Trachycarpus fortunei char.

[0013] Prescription three: 20 parts of Euphorbia humifusa, 10 parts of Sanguisorba officinalis char, 8 parts of Sophora japonica, 9 parts of Rubia cordifolia, 7 parts of Biota orientalis, 5 parts of Bletilla striata, 4 parts of Panax notoginseng, 8 parts of Agrimonia pilosa, 6 parts of Trachycarpus fortunei char.

[0014] Prescription four: 15 parts of Euphorbia humifusa, 5 parts of Sanguisorba officinalis char, 7 parts of Sophora japonica, 8 parts of Rubia cordifolia, 9 parts of Biota orientalis, 2 parts of Bletilla striata, 2 parts of Panax notoginseng, 6 parts of Agrimonia pilosa, 11 parts of Trachycarpus fortunei char.

[0015] Prescription five: 18 parts of Euphorbia humifusa, 6 parts of Sanguisorba officinalis char, 6 parts of Sophora japonica, 6 parts of Rubia cordifolia, 6 parts of Biota orientalis, 2 parts of Bletilla striata, 2 parts of Panax notoginseng, 6 parts of Agrimonia pilosa, 7 parts of Trachycarpus fortunei char.

[0016] Prescription six: 15 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis char, 8 parts of Sophora japonica, 8 parts of Rubia cordifolia, 8 parts of Biota orientalis, 4 parts of Bletilla striata, 1 part of Panax notoginseng, 7 parts of Agrimonia pilosa, 8 parts of Trachycarpus fortunei char.

[0017] In the second aspect, the present application provides a preparation method of the above-mentioned Chinese medicine composition for treating active ulcerative colitis, which comprises the following steps: weighing raw materials according to the ratio, adding 6-14 times of water or 50%-90% ethanol of the amount of crude drugs, heating and refluxing for 0.5-5 hours, adding water or 50%-90% ethanol of the amount of crude drugs, heating and refluxing for 1-3 times, filtering, combining the extract, concentrating under reduced pressure at 40-90℃, and drying to obtain the product.

[0018] As some preferred embodiments of the present application, the method comprises the following steps: S1: weighing raw materials according to the ratio for standby; S2: adding 6-14 times of water or 50%-90% ethanol to the Euphorbia humifusa, Sanguisorba officinalis char, Sophora japonica, and palm charcoal, and extracting by heating reflux for 0.5-5 hours, extracting by heating reflux for 1-3 times, filtering, combining the extract, and concentrating at 40-90 DEG C under reduced pressure for standby; S3: adding 6-14 times of water or 50%-90% ethanol to the Platycladus orientalis, Rubia, Bletilla striata, Panax notoginseng, and Agrimonia pilosa, and extracting by heating reflux for 0.5-5 hours, extracting by heating reflux for 1-3 times, filtering, combining the extract, and concentrating at 40-90 DEG C under reduced pressure for standby; S3: combining the concentrated liquids obtained in steps S1 and S2, and drying to obtain.

[0019] As some preferred embodiments of the present application, step S2 is adding 6-14 times of water to the Euphorbia humifusa, Sanguisorba officinalis char, Sophora japonica, and palm charcoal, 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 for standby; As some preferred embodiments of the present application, step S3 is adding 6-14 times of 50%-90% ethanol to the Platycladus orientalis, Rubia, Bletilla striata, Panax notoginseng, and Agrimonia pilosa, 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 for standby.

[0020] In a third aspect, the present application provides a preparation for treating active ulcerative colitis, which comprises the traditional Chinese medicine composition for treating active ulcerative colitis and at least one excipient.

[0021] 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.

[0022] In a fourth aspect, the present application provides the use of the traditional Chinese medicine composition described above in the preparation of a medicament for treating patients with diarrhea-damp-heat in the large intestine.

[0023] The composition of the present application is based on the main pathogenesis of the active stage of ulcerative colitis, that is, the downward injection of damp heat, the mutual knotting of dampness and heat, the heat damaging blood vessels, and the blood heat running wildly. According to the main pathogenesis of the mutual knotting of damp heat, the heat damaging blood vessels, and the blood heat running wildly, the method of clearing heat and cooling blood, astringing and stopping blood, and removing swelling and promoting tissue regeneration is adopted. The ground ivy is used as the monarch drug, which can not only clear and resolve the intestinal damp heat and toxic evil to treat the root cause, but also cool blood and stop bleeding to treat the symptoms. The ground ivy, sophora flower, and madder are used as the ministerial drugs, which can synergistically enhance the cooling blood and stopping bleeding of the monarch drug, and at the same time, stop bleeding without leaving stasis. The cypress leaf, sago charcoal, herbaceous peony, white yam, and sanqi are used as the auxiliary drugs, which can play the role of stopping bleeding from the aspects of cooling blood, astringing, and removing stasis, on the one hand, assist the monarch and ministerial drugs to enhance the effect of stopping bleeding, on the other hand, assist the monarch and ministerial drugs to treat the symptoms of intestinal damp heat, diarrhea, and hematochezia, and promote the healing of intestinal mucosa. The drugs can also enter the large intestine, enhance the overall therapeutic effect of the drugs. The drugs in the present application can play the role of stopping bleeding from different angles, but through the ingenious combination, the drugs can supplement the deficiency in astringency, open the obstruction in stopping, stop bleeding without leaving stasis. The drugs in the present application are all meridians of the large intestine, which can guide the drugs to the large intestine, enhance the overall therapeutic effect of the drugs. The present application provides a new application idea for the treatment of ulcerative colitis in the active stage. The combination of the drugs can achieve the effects of clearing heat and cooling blood, astringing and stopping blood, and removing swelling and promoting tissue regeneration, which is suitable for the patients with ulcerative colitis in the active stage, and the main manifestations are hematochezia, abdominal pain, and tenesmus, which are caused by the mutual knotting of damp heat, the heat damaging blood vessels, and the blood heat running wildly.

[0024] The beneficial effects of the composition of the present application are as follows: The composition of the present application is based on the main pathogenesis of the active stage of ulcerative colitis, that is, the downward injection of damp heat, the mutual knotting of dampness and heat, the heat damaging blood vessels, and the blood heat running wildly. According to the main pathogenesis of the mutual knotting of damp heat, the heat damaging blood vessels, and the blood heat running wildly, the method of clearing heat and cooling blood, astringing and stopping blood, and removing swelling and promoting tissue regeneration is adopted. The ground ivy is used as the monarch drug, which can not only clear and resolve the intestinal damp heat and toxic evil to treat the root cause, but also cool blood and stop bleeding to treat the symptoms. The ground ivy, sophora flower, and madder are used as the ministerial drugs, which can synergistically enhance the cooling blood and stopping bleeding of the monarch drug, and at the same time, stop bleeding without leaving stasis. The cypress leaf, sago charcoal, herbaceous peony, white yam, and sanqi are used as the auxiliary drugs, which can play the role of stopping bleeding from the aspects of cooling blood, astringing, and removing stasis, on the one hand, assist the monarch and ministerial drugs to enhance the effect of stopping bleeding, on the other hand, assist the monarch and ministerial drugs to treat the symptoms of intestinal damp heat, diarrhea, and hematochezia, and promote the healing of intestinal mucosa. The drugs can also enter the large intestine, enhance the overall therapeutic effect of the drugs. The drugs in the present application can play the role of stopping bleeding from different angles, but through the ingenious combination, the drugs can supplement the deficiency in astringency, open the obstruction in stopping, stop bleeding without leaving stasis. The drugs in the present application are all meridians of the large intestine, which can guide the drugs to the large intestine, enhance the overall therapeutic effect of the drugs. The present application provides a new application idea for the treatment of ulcerative colitis in the active stage. The combination of the drugs can achieve the effects of clearing heat and cooling blood, astringing and stopping blood, and removing swelling and promoting tissue regeneration, which is suitable for the patients with ulcerative colitis in the active stage, and the main manifestations are hematochezia, abdominal pain, and tenesmus, which are caused by the mutual knotting of damp heat, the heat damaging blood vessels, and the blood heat running wildly. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is the mouse weight chart in the effect example of the present application; Figure 2 is the typical pathological chart of the mouse in the present application. The left column is 40 times of the microscope, and the right column is 200 times of the microscope. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical scheme and advantages of the present application clearer, the present application will be described in detail below with specific examples.

[0027] The various terms and phrases used in the present application have the general meanings known to those skilled in the art, even though the present application still wishes to make more detailed explanation and interpretation of these terms and phrases here, and the terms and phrases mentioned are subject to the meanings expressed in the present application if they are inconsistent with the known meanings.

[0028] In the present application, the term "Euphorbia Humilis", whose Latin name is Euphorbia Humifusae Herb is the dry whole herb of Euphorbia Humilis Euphorbia humifusa Willd. or Euphorbia Humilis var. Euphorbia maculata L. It is collected in summer and autumn, impurities are removed, and dried.

[0029] In the present application, the term "Radix Ulmarae Carbonisata", whose Latin name is Carbonized Sanguisorba Root is the dry root of Ulmus pumila L. Sanguisorba officinalis L. or Ulmus macrocarpa Hance eelgrass officinalis L. var. longifolia (Bert.) Yüet Li The latter is commonly known as "Mian Ulmarae". It is dug up when sprouting in spring or after the plant withers in autumn, the rootlets are removed, washed and dried, or fresh sliced, dried, and prepared by roasting and carbonization.

[0030] In the present application, the term "Flos Sophorae", whose Latin name is Sophora Flower is the dry flower and flower bud of Sophora japonica L. Sophora japonica L.'s It is collected when the flower opens or the flower bud forms in summer, dried in time, and impurities are removed.

[0031] In the present application, the term "Rubia Cordifolia", whose Latin name is Rubia Root and Rhizoma is the dry root and rhizome of Rubia Cordifolia L. Rubia cordifolia L. It is dug up in spring and autumn, and dried after removing the mud and sand.

[0032] In the present application, the term "Cacumen Platycladi", whose Latin name is The peak of Platyclades, is the dry branchlet and leaf of Platycladus orientalis (L.) Franco. Platycladus orientalis (L.) Franco It is usually collected in summer and autumn, and dried in the shade.

[0033] In the present application, the term "Bletilla Striata", whose Latin name is Rhizoma of Bletillae, is the dry tuber of Bletilla Striata Reichb. 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 core, dried to half dry, the outer skin is removed, and dried.

[0034] In the present application, the term "Radix et Rhizoma Notoginseng", whose Latin name is Notoginseng Root and Rhizoma is the dry root and rhizome of Panax Notoginseng (Burk.) F. H. Chen. Panax notoginseng (Burk.) FHChen It is dug up in autumn before the flower opens, washed, separated into main roots, branch roots and rhizomes, and dried.

[0035] In the present application, the term "Herba Agrimoniae", whose Latin name is Agrimony HerbThe dried aerial part of Euphorbia humifusa Agrimonia pilosa Ledeb. is collected in summer and autumn when the stems and leaves are lush, impurities are removed, and dried.

[0036] In the present application, the term "palm charcoal" has the Latin name Carbonized Trachycarpa , and is the dried petiole or leaf sheath fiber of the palm Trachycarpus fortunei (Hook. f.) H. Wendl. processed by a specific processing method (calcination).

[0037] The various instruments, devices, equipment, reagents, products, etc. used in the embodiments of the present application are obtained through conventional commercial channels unless otherwise specified.

[0038] Example 1 A traditional Chinese medicine composition for treating active ulcerative colitis, the raw materials of which include, by weight, 30 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis charcoal, 7 parts of Sophora japonica, 7 parts of Rubia cordifolia, 6 parts of Biota orientalis, 3 parts of Bletilla striata, 2 parts of Panax notoginseng, 4 parts of Agrimonia pilosa, and 10 parts of Trachycarpus fortunei charcoal.

[0039] Specific preparation steps are as follows: S1: Take Euphorbia humifusa, Sanguisorba officinalis charcoal, Sophora japonica, and Trachycarpus fortunei charcoal and add 12 times the amount of water of the crude drug, reflux extract for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of 80% ethanol of the crude drug to the residue, reflux extract for 2 hours, filter, and combine the two extract solutions. Concentrate at 60°C under reduced pressure to a density of 1.08, and reserve. S2: Take Biota orientalis, Rubia cordifolia, Bletilla striata, Panax notoginseng, and Agrimonia pilosa and add 12 times the amount of 80% ethanol of the crude drug, reflux extract for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of water of the crude drug to the residue, reflux extract for 2 hours, filter, and combine the two extract solutions. Concentrate at 60°C under reduced pressure to a density of 1.08, and reserve. S3: Combine the concentrated solutions of steps S1 and S2, continue to concentrate to a density of 1.10, dry at 70°C, and then crush the dry extract to add excipients to prepare a capsule, thereby obtaining the present composition 1.

[0040] Example 2 A traditional Chinese medicine composition for treating active ulcerative colitis, the raw materials of which include, by weight, 25 parts of Euphorbia humifusa, 7 parts of Sanguisorba officinalis charcoal, 6 parts of Sophora japonica, 8 parts of Rubia cordifolia, 6 parts of Biota orientalis, 2 parts of Bletilla striata, 3 parts of Panax notoginseng, 3 parts of Agrimonia pilosa, and 8 parts of Trachycarpus fortunei charcoal.

[0041] Specific preparation steps are as follows: S1: Take Euphorbia humifusa, Sanguisorba officinalis charcoal, Sophora japonica, and Trachycarpus fortunei charcoal and add 12 times the amount of water of the crude drug, reflux extract for 2 hours, filter, and reserve the filtrate. Add 12 times the amount of 80% ethanol of the crude drug to the residue, reflux extract for 2 hours, filter, and combine the two extract solutions. Concentrate at 60°C under reduced pressure to a density of 1.08, and reserve. S2: Take Platycladus orientalis, Rubia cordifolia, Bletilla striata, Panax notoginseng, Agrimonia eupatoria 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, filter for use, the residue is added 12 times the amount of water, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, ready for use; S3: The concentrated liquid of step S1 and S2 is combined, and further concentrated to a density of 1.10, dried at 70°C, and then crushed to add 10% malt dextrin to adjust the dosage, prepared into granules, and the inventive composition 2 is obtained.

[0042] Example 3 A traditional Chinese medicine composition for treating active ulcerative colitis, the raw materials of which include, by weight, 20 parts of Euphorbia humifusa, 10 parts of Sanguisorba officinalis carbon, 8 parts of Sophora japonica, 9 parts of Rubia cordifolia, 7 parts of Platycladus orientalis, 5 parts of Bletilla striata, 4 parts of Panax notoginseng, 8 parts of Agrimonia eupatoria, and 6 parts of Areca carbon.

[0043] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba officinalis carbon, Sophora japonica, and Areca carbon, add 12 times the amount of water, reflux extraction 2 hours, filter, filter for use, the residue is added 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, ready for use; S2: Take Platycladus orientalis, Rubia cordifolia, Bletilla striata, Panax notoginseng, and Agrimonia eupatoria 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, filter for use, the residue is added 12 times the amount of water, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, ready for use; S3: The concentrated liquid of step S1 and S2 is combined, and further concentrated to a density of 1.10, dried at 70°C, and then crushed to add 10% malt dextrin to adjust the dosage, prepared into granules, and the inventive composition 2 is obtained.

[0044] Example 4 A traditional Chinese medicine composition for treating active ulcerative colitis, the raw materials of which include, by weight, 15 parts of Euphorbia humifusa, 5 parts of Sanguisorba officinalis carbon, 7 parts of Sophora japonica, 8 parts of Rubia cordifolia, 9 parts of Platycladus orientalis, 2 parts of Bletilla striata, 2 parts of Panax notoginseng, 6 parts of Agrimonia eupatoria, and 11 parts of Areca carbon.

[0045] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba officinalis carbon, Sophora japonica, and Areca carbon, add 12 times the amount of water, reflux extraction 2 hours, filter, filter for use, the residue is added 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, ready for use; S2: Take Platycladus orientalis, madder, white and three seven, 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, filter for use, the residue added 12 times the amount of water, reflux extraction 2 hours, filter, combined 2 times the extraction liquid, concentrated to density 1.08 at 60 ℃ under reduced pressure, ready for use; S3: The concentrated liquid of step S1 and S2 is combined, and continues to concentrate to density 1.10, dried at 70℃, and then crushed to add 10% malt dextrin to adjust the dosage, and then prepared into granules, which is the composition 4 of the application.

[0046] Example 5 A Chinese medicine composition for treating active ulcerative colitis, which raw materials include, by weight, 18 parts of Euphorbia humifusa, 6 parts of Sanguisorba officinalis carbon, 6 parts of Sophora japonica, 6 parts of madder, 6 parts of Platycladus orientalis, 2 parts of white and 2 parts of Panax notoginseng, 6 parts of Agrimonia pilosa, and 7 parts of Areca carbon.

[0047] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba officinalis carbon, Sophora japonica, and Areca carbon, add 10 times the amount of water, reflux extraction 1.5 hours, filter, filter for use, the residue added 10 times the amount of 60% ethanol, reflux extraction 1.5 hours, filter, combined 2 times the extraction liquid, concentrated to density 1.08 at 60 ℃ under reduced pressure, ready for use; S2: Take Platycladus orientalis, madder, white and three seven, 10 times the amount of 60% ethanol, reflux extraction 1.5 hours, filter, filter for use, the residue added 10 times the amount of water, reflux extraction 1.5 hours, filter, combined 2 times the extraction liquid, concentrated to density 1.08 at 70 ℃ under reduced pressure; S3: The concentrated liquid of step S1 and S2 is combined, and continues to concentrate to 1.12, and then dried at 60℃, and then crushed to add 10% malt dextrin, and then prepared into capsules, which is the composition 5 of the application.

[0048] Example 6 A Chinese medicine composition for treating active ulcerative colitis, which raw materials include, by weight, 15 parts of Euphorbia humifusa, 8 parts of Sanguisorba officinalis carbon, 8 parts of Sophora japonica, 8 parts of madder, 8 parts of Platycladus orientalis, 4 parts of white and 1 part of Panax notoginseng, 7 parts of Agrimonia pilosa, and 8 parts of Areca carbon.

[0049] Specific preparation steps: S1: Take Euphorbia humifusa, Sanguisorba officinalis carbon, Sophora japonica, and Areca carbon, add 10 times the amount of water, reflux extraction 1.5 hours, filter, filter for use, the residue added 10 times the amount of 60% ethanol, reflux extraction 1.5 hours, filter, combined 2 times the extraction liquid, concentrated to density 1.08 at 60 ℃ under reduced pressure, ready for use; S2: Take the cypress leaves, madder, white, Sanqi, Xianhe grass plus 10 times the amount of 60% ethanol, reflux extraction 1.5 hours, filter, filter for use, the residue plus 10 times the amount of water, reflux extraction 1.5 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 70°C under reduced pressure; S3: The concentrated liquid of step S1 and S2 were combined and continued to concentrate to 1.12, the concentrated liquid was dried at 60°C, the dried extract was crushed and then 10% malt dextrin was added to adjust the dosage, and granules were prepared, thus obtaining the inventive composition 6.

[0050] Comparative Example 1 A traditional Chinese medicine composition for treating ulcerative colitis, the raw materials of which include, by weight, 100 parts of Chinese sumac; 120 parts of Ganoderma lucidum; 80 parts of white willow; 70 parts of purple olive leaves; 50 parts of Sophora flavescens; 30 parts of Herba Agrimoniae; 60 parts of Rubia cordifolia; 30 parts of Poria cocos; 30 parts of Gorgon nut; 20 parts of Platycladus orientalis; 30 parts of Sophora japonica; 40 parts of Concha Arcae; 20 parts of gallnut; 30 parts of Bletilla striata; 20 parts of Uncaria; and 15 parts of Sanqi.

[0051] Specific preparation steps are as follows: ①Take Chinese sumac, white willow, Sophora japonica, Ganoderma lucidum, Sophora flavescens, Poria cocos, Gorgon nut, Concha Arcae, gallnut, and Uncaria, and add 12 times the amount of water, reflux extraction 2 hours, filter, filter for use, the residue plus 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, for use; ②Take Platycladus orientalis, purple olive leaves, Rubia cordifolia, Bletilla striata, Sanqi, and Herba Agrimoniae, and add 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, filter for use, the residue plus 12 times the amount of water, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, and combine the concentrated liquid of step ①, continue to concentrate to a density of 1.10, for use; ③Dry the concentrated liquid of step ② at 70°C, crush the dried extract, then add 10% malt dextrin to adjust the dosage, and prepare granules, thus obtaining comparative composition 1.

[0052] Comparative Example 2 A traditional Chinese medicine composition for treating ulcerative colitis, the raw materials of which include, by weight, 20 parts of Chinese sumac, 8 parts of white willow charcoal, 6 parts of Gorgon nut, 3 parts of Bletilla striata, 2 parts of gallnut, 0.2 parts of Uncaria, and 0.09 parts of pearl powder Specific preparation steps are as follows: ①Take Chinese sumac, white willow charcoal, Uncaria, and pearl powder, and add 12 times the amount of water, reflux extraction 2 hours, filter, filter for use, the residue plus 12 times the amount of 80% ethanol, reflux extraction 2 hours, filter, combined 2 times the extract, concentrated to a density of 1.08 at 60°C under reduced pressure, for use; ii) Take Ginkgo, white and gallnut plus 12 times the amount of 80% ethanol, reflux extraction for 2 hours, filter, filter for use, the residue plus 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two extraction liquid, concentrated to density 1.08 at 60°C under reduced pressure, combine the concentrated liquid of step i), continue to concentrate to density 1.10, for use; iii) Dry the concentrated liquid of step ii) at 70°C, crush the dry paste, add 10% malt dextrin to adjust the dosage, prepare into granules, the comparative composition 2 is obtained.

[0053] Comparative Example 3 A Chinese medicine composition for treating ulcerative colitis, the raw materials include, by weight, 23 parts of Chinese mercury grass, 10 parts of Ganoderma lucidum, 8 parts of Poria cocos, 6 parts of Agrimonia eupatoria, 6 parts of Sanguisorba officinalis, 5 parts of Sophora flavescens, 2 parts of Bletilla striata, and 4 parts of Panax notoginseng.

[0054] Specific preparation steps: i) Take Ginkgo, white and gallnut plus 12 times the amount of 80% ethanol, reflux extraction for 2 hours, filter, filter for use, the residue plus 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two extraction liquid, concentrated to density 1.08 at 60°C under reduced pressure, combine the concentrated liquid of step i), continue to concentrate to density 1.10, for use; ii) Take Ginkgo, white and gallnut plus 12 times the amount of 80% ethanol, reflux extraction for 2 hours, filter, filter for use, the residue plus 12 times the amount of water, reflux extraction for 2 hours, filter, combine the two extraction liquid, concentrated to density 1.08 at 60°C under reduced pressure, combine the concentrated liquid of step i), continue to concentrate to density 1.10, for use; iii) Dry the concentrated liquid of step ii) at 70°C, crush the dry paste, add 10% malt dextrin to adjust the dosage, prepare into granules, the comparative composition 2 is obtained.

[0055] Example 1 animal efficacy test 1 Test purpose DSS is used to construct a mouse model of ulcerative colitis, and the effectiveness and mechanism of different Chinese medicine compositions in treating mouse ulcerative colitis are investigated.

[0056] 2 Test design 2.1 Experimental method SPF male C57BL / 6J mice, 6-8 weeks old, weighing 20±2g, after adaptive feeding, according to the body weight, randomly divided into normal control group and modeling group, 5 animals in normal control group, 85 animals in modeling group, normal feeding in normal control group, and 2% DSS drinking water in modeling group. After modeling for 7 days, the modeling group is divided into model control group, positive control group, and Chinese medicine composition group according to the DAI score, see Table 1 for specific grouping and administration scheme.

[0057] Table 1 mouse grouping information table

[0058] 2.2 detection index Table 2 detection index

[0059] 2.3 statistical analysis For quantitative data, first, the data homogeneity test is performed by Bartlett test method. If the data is homogeneous (test P≥0.05), the variance analysis test (F test) is performed. If the result of Bartlett test is significant (p<0.05), the Kruskal-wallis test is performed. ②If the result of variance analysis test is significant (p<0.05), further multiple comparison test is performed by Dunett parameter test method. If the result of variance analysis is not significant (p≥0.05), the statistics is ended. ③If the result of Kruskal-wallis test is significant (p<0.05), further multiple comparison test is performed by Dunett non-parametric test method. If the result of Kruskal-wallis test is not significant, the statistics is ended.

[0060] 3 experimental results 3.1 clinical observation Under the conditions of this experiment, all animals in each group survived until the end of the experiment. All animals in the blank control group were clinically observed to be normal, and the animal's mental state was good. After modeling, some animals showed reduced movement from D5, and all modeling animals showed decreased activity from D7. After administration, 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.

[0061] 3.2 modeling results Under the conditions of this 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 significantly higher scores than the normal control group (p<0.001), indicating that the model was successfully established. The DAI score results are shown in Table 3.

[0062] Table 3 DAI score table after 7 days of modeling (x±SD)

[0063] Note: *** represents comparison with the normal control group p <0.001 3.3 experimental results of administration 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 animals in the positive drug group was significantly higher than that in the model control group (p<0.05, p<0.01, p<0.001); the body weight of the animals in the traditional Chinese medicine composition groups 1-4 was significantly higher than that in 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 animals in the traditional Chinese medicine composition group 2 was always higher than that in the other three groups, and was significantly higher than that in 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 in the traditional Chinese medicine composition group 3 in D12 and D13 (p<0.05). See Tables 4-5. Figure 1 .

[0064] 3.3.2 Body weight score According to the decrease of animal body weight, the body weight score was performed. The model control group was significantly higher than the normal group with statistical difference (p<0.001); the positive control group was significantly different from the model control group 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.

[0065] Table 4 Body weight score table (x±SD)

[0066] 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 5 Body weight score table (x ± SD)

[0068] 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.

[0069] 3.3.3 Fecal occult blood score After modeling, fecal occult blood was detected in the model group animals, and the detection score of each group before administration was higher than 1 (reagent coloration time index), which had a significant difference (p < 0.001) compared with the blank control group. After grouping and administration, the occult blood of the positive control group and the test product group (traditional Chinese medicine composition groups 1-4) was no longer aggravated, and gradually reduced. The model control group, the occult blood gradually aggravated over time. During the administration period: the model control group had a significant difference (p < 0.001) compared with the normal control group; the positive control group had a significant difference (p < 0.01) compared with the model control group on D10 (the third day of administration), and then had a very significant difference (p < 0.001) compared with the model control group; the traditional Chinese medicine composition group 1 had a significant difference (p < 0.05) compared with the model control group on D9 and D10 (the second and third days of administration), and then had a very significant difference (p < 0.001) compared with the model control group; the traditional Chinese medicine composition group 2 had a very significant difference (p < 0.001) compared with the model control group since D11 (the fourth day of administration); the traditional Chinese medicine composition group 3 had a significant difference (p < 0.05) compared with the model control group on D10 (the third day of administration), and then had a very significant difference (p < 0.001) compared with the model control group; the traditional Chinese medicine composition group 4 had a significant difference (p < 0.05) compared with the model control group on D9 and D10 (the second and third days of administration), and then had a very significant difference (p < 0.001) compared with the model control group. See Tables 6-7.

[0070] Table 6 Occult blood score table (x ± SD)

[0071] 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.

[0072] Table 7 Occult blood score table (x ± SD)

[0073] Note: *** represents p<0.001 compared with normal control group; ### represents p<0.001 compared with model control group; ## represents p<0.01 compared with model control group; # represents p<0.05 compared with model control group.

[0074] 3.3.4 Stool viscosity score After modeling, the stool viscosity of the modeling group animals increased significantly, which was significantly different from 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 weakened. The viscosity of the model control group gradually aggravated over time. During the administration period: the viscosity increase of the model control group compared with the normal control group showed no significant difference on D8, and then showed significant difference (p<0.001) during the test period; the positive control group showed significant difference (p<0.01) compared with the model control group on D9 and D10 (the second and third days of administration), and then showed extremely significant difference (p<0.001) compared with the model control group; the traditional Chinese medicine composition 1 group showed significant difference (p<0.01, p<0.001) compared with the model control group; the traditional Chinese medicine composition 2 group showed significant difference (p<0.05) compared with the model control group from D9 to D12 (the second to fifth days of administration), showed significant difference (p<0.01) from D13 to D14 (the sixth and seventh days of administration), and then showed extremely significant difference (p<0.001) compared with the model control group; the traditional Chinese medicine composition 3 group showed significant difference (p<0.05) compared with the model control group on D11 and D12 (the fourth and fifth days of administration), showed significant difference (p<0.01) from D13 to D14 (the sixth and seventh days of administration), and then showed extremely significant difference (p<0.001) compared with the model control group; the traditional Chinese medicine composition 4 group showed significant difference (p<0.01) compared with the model control group from D9 to D12 (the second to fifth days of administration), and then showed extremely significant difference (p<0.001) compared with the model control group. See Tables 8-9.

[0075] Table 8 Viscosity score table (x±SD)

[0076] Note: *** represents p<0.001 compared with normal control group p <0.001; ### represents p<0.001 compared with model control group p <0.001, ## represents p<0.01 compared with model control group p <0.01, # represents p<0.05 compared with model control group p <0.05.

[0077] Table 9 Viscosity score table (x±SD)

[0078] Note: *** represents p<0.001 compared with the normal control group p <0.001; ### represents p<0.001 compared with the model control group p <0.001, ## represents p<0.01 compared with the model control group p <0.01, # represents p<0.05 compared with the model control group p <0.05.

[0079] 3.3.5 DAI score The DAI numerical score of each group was calculated according to the body weight score, occult blood score and fecal viscosity score. During the treatment period: there was a significant difference (p<0.001) between the model control group and the normal control group; there was a significant difference (p<0.01, p<0.001) between the positive control group and the model control group; there was a significant difference (p<0.05, p<0.01, p<0.001) between the traditional Chinese medicine composition groups 1-4 and the model control group; comparison between the traditional Chinese medicine composition groups 1-4 showed that the traditional Chinese medicine composition groups 2 and 4 were significantly lower than the traditional Chinese medicine composition group 1 (p<0.05, p<0.01, p<0.001) on D3-9, and the traditional Chinese medicine composition groups 2 and 4 were better than the traditional Chinese medicine composition group 3 in terms of score results, and the traditional Chinese medicine composition group 1 had the slowest effect. See Tables 10-11.

[0080] Table 10 DAI score table (x±SD)

[0081] 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, # represents p<0.05 compared with the model control group.

[0082] Table 11 DAI score table (x±SD)

[0083] 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, # represents p<0.05 compared with the model control group.

[0084] 3.3.6 Colon weight coefficient After modeling, the colon weight coefficient of the modeling group was significantly reduced. Compared with the model control group, the normal control group was significantly reduced (p<0.05); the positive control group and the model control group were significantly increased (p<0.001); the Chinese medicine composition 1 group was significantly increased compared with the model control group (p<0.05); the Chinese medicine composition 2 group was increased compared with the model control group, but no difference was found (p>0.05); the Chinese medicine composition 3 group was increased compared with the model control group, but no difference was found (p>0.05); the Chinese medicine composition 4 group was significantly increased compared with the model control group (p<0.01). See Table 12.

[0085] Table 12 Colon weight coefficient table (x ± SD)

[0086] 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.

[0087] 3.3.6 Pathological results After histopathological examination, it was found 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, long tubular, and the number of goblet cells was rich; the smooth muscle cells in the muscularis mucosae separated the intestinal glands from the submucosa, which 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, long tubular, and the number of goblet cells was rich; the smooth muscle cells in the muscularis mucosae separated the intestinal glands from the submucosa, which 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 Figure 2 .

[0088] 4 Discussion In clinical, UC most often occurs in young adults, according to the statistical data of China, the peak age of incidence is 20-49 years old, there is no significant difference between men and women. UC is characterized by persistent or recurrent diarrhea, mucous blood stool, abdominal pain and tenesmus, etc. In clinical, it is divided into active and remission period according to the course of 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 show mucous blood stool in most studies. Physical examination should pay special attention to the general condition and nutritional status of the patient, and conduct detailed abdominal, perianal, perineal examination and digital rectal examination. At the same time, pay attention to the extraintestinal manifestations and perianal conditions of mouth, skin, joints, eyes, etc.

[0089] The experiment successfully established a mouse model of UC, and compared the efficacy of active and remission periods. Under the conditions of this experiment, the Chinese medicine compositions 1-4 in the test product group had good protective effect on the weight loss of the model mice. For this test, DAI score and pathology are the two gold indicators of this model, among which DAI score can see the improvement of the drug on the weight loss, diarrhea, mucous blood stool, abdominal pain and tenesmus caused by UC, and pathology can directly see the protection of the drug to the colon. From the two indicators to observe the effectiveness of different test products in this case, it can be seen that the weight and DAI score of Chinese medicine composition 1 are the worst in the first 9 days, but from the 9th day onwards, the weight and blood stool gradually recover, and finally show good intestinal protection in pathology. The weight protection effect of Chinese medicine composition 2 is the best, the DAI score is significantly better than that of Chinese medicine composition 4, the pathology is only second to 3, the effect is the fastest, and finally also has good intestinal protection effect. The weight and DAI score of Chinese medicine composition 3 have been at a medium level, but the protection effect on intestinal damage in pathology is the best. The weight and DAI score of Chinese medicine composition 4 are inferior to Chinese medicine composition 2. According to the clinical manifestations of UC and the efficacy of the 4 drugs, the effectiveness of the drugs in this case is Chinese medicine composition 2> Chinese medicine composition 3> Chinese medicine composition 4> Chinese medicine composition 1. In the treatment of active UC, Chinese medicine composition 2 group, i.e. the composition 2 of the invention, is better than the other three comparative compositions.

[0090] 5CONCLUSION The ulcerative colitis mouse model is successfully established. Under the experimental conditions, the traditional Chinese medicine compositions (traditional Chinese medicine compositions 1-4) in the test product group have good protective effect on the body weight reduction of the model mice, relieve the hematochezia of the model mice, prevent the model from deteriorating, and have good repair effect on the intestinal tract. Combined with the body weight and pathological performance, the effectiveness of the drugs in this test is ranked as 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 the remission stage, the traditional Chinese medicine composition 2 group, that is, the inventive composition 2, is better than the other three comparative compositions.

[0091] Typical cases of clinical application of the traditional Chinese medicine composition of the present application: Case 1: Sun, male, 30 years old, the patient has intermittent mucous and pus blood stool for more than 10 years, and has aggravated for 1 year. The patient was diagnosed as ulcerative colitis by colonoscopy 10 years ago due to pus blood stool, and the symptoms were slightly relieved after treatment by traditional Chinese and western medicine (specifically unknown), intermittent attack, and the patient had 3-5 times of stool per day, with blood and mucus, accompanied by abdominal distension, intestinal rumbling, and a lot of exhaust, red tongue, yellow and greasy fur, and slippery pulse, which was diarrhea-damp heat in the large intestine. The patient took the traditional Chinese medicine composition 2 of the present application, 10g twice a day, for 1 month, and the mucous and pus blood in stool was significantly reduced, and the stool quality was thicker than before. After 3 months of follow-up, the patient had 1-2 times of stool per day, and did not complain of hematochezia, abdominal distension and other discomforts.

[0092] Case 2: Zhao, female, 35 years old, the patient was treated due to intermittent abdominal pain and diarrhea for 2 weeks. Two weeks ago, the patient had diarrhea without inducement, 2-4 times a day, with blood and white mucus in stool, and occasional anal prolapse. Electronic colonoscopy showed that the sigmoid colon mucosa was significantly hyperemic and edematous, accompanied by mucous secretion, scattered superficial ulcer on the mucosal surface, covered with mucous-like white fur and a small amount of bleeding, and the examination diagnosis was ulcerative colitis. The tongue was red, the fur was slightly yellow and greasy, and the pulse was thin and stringy, which was diarrhea-damp heat in the large intestine. The patient took the traditional Chinese medicine composition 2 of the present application, 10g twice a day, for 1 month, and the symptoms of abdominal pain and diarrhea were gradually relieved, and the mucus in stool was reduced compared with before. After half a year of follow-up, the patient's symptoms did not worsen.

[0093] Case 3: Bai, male, 40 years old, the patient had intermittent abdominal pain and mucous and pus blood stool for more than 1 month. More than 1 month ago, the patient had abdominal pain and diarrhea after continuous drinking for many days, with mucous and pus blood stool, and was accompanied by anal burning discomfort, food intake was still possible, and occasional mouth dryness. Colonoscopy showed ulcerative colitis. The tongue was red, the fur was yellow and greasy, and the pulse was thin and slippery, which was diarrhea-damp heat in the large intestine. The patient took the traditional Chinese medicine composition 2 of the present application, 10g twice a day, for 2 weeks, and the symptoms of abdominal pain and pus blood stool were improved, and the anal burning sensation gradually disappeared.

[0094] Case 4: Geng, female, 46 years old, complained of abdominal pain, pus and blood stool for more than 1 month. 1 month ago, the patient had abdominal pain, pus and blood stool, and anal prolapse. Colonoscopy confirmed ulcerative colitis. The patient had 3-4 stools per day, pus and blood stool, anal burning, short and dark urine, and bitter taste in the mouth. The patient had a history of eating fatty, sweet and spicy food. Physical examination showed red tongue, yellow and greasy fur, and slippery pulse, which was diarrhea-dampness in the large intestine. The patient took the traditional Chinese medicine composition 2, 2 times a day, 10g each time, for 2 weeks. The patient's abdominal pain and pus and blood stool were relieved, and the amount of mucus in the stool was reduced. The stool was basically formed, and there were occasional anal burning, short and dark urine, and bitter taste in the mouth. The treatment effect was satisfactory.

[0095] Case 5: Ge, female, 56 years old, complained of abdominal pain, diarrhea, and blood stool for more than 1 month. 1 month ago, the patient had abdominal pain, diarrhea, and blood stool. Electronic colonoscopy showed mild hyperemia and edema of the sigmoid colon mucosa, with white mucus secretion. Scattered superficial ulcers were observed on the mucosal surface, with an area of about 1.5x1 cm. A small amount of bleeding was observed. Diagnosis: Ulcerative colitis. The patient had 3-5 stools per day, mixed with fresh blood and white mucus. Oral mesalazine enteric-coated tablets could alleviate the symptoms, but the symptoms recurred. The tongue was red, the fur was thin and yellow, and the pulse was slippery, which was diarrhea-dampness in the large intestine. The patient took the traditional Chinese medicine composition 2, 2 times a day, 10g each time, for half a month. The patient's abdominal pain and diarrhea were significantly reduced, and the stool was paste-like without obvious blood in the stool. The remaining symptoms were basically gone. Six months later, colonoscopy showed that the rectal mucosa was smooth and there was no obvious lesion.

[0096] Case 6: Kong, female, 47 years old, complained of intermittent lower abdominal pain and diarrhea for 2 months. 2 months ago, the patient had lower abdominal pain and diarrhea. Electronic colonoscopy showed ulcerative colitis 12 cm below the anus. Oral Huangliansu and Blakeslea trispora were still intermittently discharged mucus, 3-4 times a day. The tongue was red, the fur was yellow, and the pulse was slippery, which was diarrhea-dampness in the large intestine. The patient took the traditional Chinese medicine composition 2, 2 times a day, 10g each time, for 1 month. The patient's abdominal pain and diarrhea were relieved, and the stool was paste-like with reduced mucus. After 3 months of follow-up, the patient's stool was basically normal, and the symptoms of abdominal pain, diarrhea, and mucus did not recur.

[0097] Case 7: Zeng, male, 74 years old, diagnosed with ulcerative colitis for more than 3 years, and aggravated for more than 1 month. 3 years ago, the patient was diagnosed with ulcerative colitis due to diarrhea and pus and blood stool. After symptomatic treatment with western medicine, the symptoms were controlled, and the patient took medicine intermittently to maintain. 1 month ago, the patient's condition recurred, with 5-6 stools per day, a small amount of mucus, and pus and blood. The patient also had bitter taste in the mouth, dry mouth, and no obvious abdominal pain. The tongue was red, the fur was yellow and greasy, and the pulse was slippery, which was diarrhea-dampness in the large intestine. The patient took the traditional Chinese medicine composition 2, 2 times a day, 10g each time, for 2 months. The patient's diarrhea, pus and blood mucus symptoms were significantly reduced, and the stool was basically formed. After 1 month of follow-up, the patient's stool was basically normal and did not affect normal life.

[0098] Case 8: Gao, male, 76 years old, the patient was diagnosed with ulcerative colitis 20 years, relapse for more than 1 month. The patient was diagnosed with ulcerative colitis 20 years ago, and the patient reported that the treatment was improved by traditional Chinese and Western medicine, and the specific medication was unknown. More than 1 month ago, abdominal pain, diarrhea and mucous and bloody stool again, complained of 1-2 times of stool per day, accompanied by anal burning and a feeling of sinking, no obvious dry mouth and bitter taste, dark red tongue, yellow and greasy fur, pulse stringy and slippery, for diarrhea-dampness in the large intestine. Take the traditional Chinese medicine composition 2, 3 months, 2 times a day, 10g each time, the patient's abdominal pain, diarrhea and bloody stool improved, stool not shaped, still a small amount of white mucus, the rest of the symptoms basically disappeared. Follow-up after 6 months, the patient's stool was basically normal, and the symptoms of abdominal pain, diarrhea and bloody stool did not recur.

[0099] Although the present application is described in detail with reference to the foregoing embodiments, those skilled in the art can modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for part of the technical features; and these modifications or substitutions do not make the essence of the corresponding technical solutions 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 active ulcerative colitis, characterized in that, It is composed of raw materials in the following weight ratio: Euphorbia humifusa 5-35 parts, Sanguisorba officinalis carbon 3-12 parts, Sophora japonica 3-12 parts, Rubia cordifolia 3-12 parts, Biota orientalis 3-12 parts, Bletilla striata 1-6 parts, Panax notoginseng 0.5-5 parts, Agrimonia pilosa 2-10 parts, and Palm carbon 3-12 parts.

2. The traditional Chinese medicine composition for treating active ulcerative colitis according to claim 1, characterized in that, It is composed of raw materials in the following weight ratio: Euphorbia humifusa 15-30 parts, Sanguisorba officinalis carbon 5-10 parts, Sophora japonica 6-8 parts, Rubia cordifolia 6-9 parts, Biota orientalis 6-9 parts, Bletilla striata 2-5 parts, Panax notoginseng 1-4 parts, Agrimonia pilosa 3-8 parts, and Palm carbon 7-11 parts.

3. The traditional Chinese medicine composition for treating active ulcerative colitis according to claim 1, characterized in that, It is composed of raw materials in the following weight ratio: Prescription one: Euphorbia humifusa 30 parts, Sanguisorba officinalis carbon 8 parts, Sophora japonica 7 parts, Rubia cordifolia 7 parts, Biota orientalis 6 parts, Bletilla striata 3 parts, Panax notoginseng 2 parts, Agrimonia pilosa 4 parts, and Palm carbon 10 parts; Prescription two: Euphorbia humifusa 25 parts, Sanguisorba officinalis carbon 7 parts, Sophora japonica 6 parts, Rubia cordifolia 8 parts, Biota orientalis 6 parts, Bletilla striata 2 parts, Panax notoginseng 3 parts, Agrimonia pilosa 3 parts, and Palm carbon 8 parts; Prescription three: Euphorbia humifusa 20 parts, Sanguisorba officinalis carbon 10 parts, Sophora japonica 8 parts, Rubia cordifolia 9 parts, Biota orientalis 7 parts, Bletilla striata 5 parts, Panax notoginseng 4 parts, Agrimonia pilosa 8 parts, and Palm carbon 6 parts; Prescription four: Euphorbia humifusa 15 parts, Sanguisorba officinalis carbon 5 parts, Sophora japonica 7 parts, Rubia cordifolia 8 parts, Biota orientalis 9 parts, Bletilla striata 2 parts, Panax notoginseng 2 parts, Agrimonia pilosa 6 parts, and Palm carbon 11 parts; Prescription five: Euphorbia humifusa 18 parts, Sanguisorba officinalis carbon 6 parts, Sophora japonica 6 parts, Rubia cordifolia 6 parts, Biota orientalis 6 parts, Bletilla striata 2 parts, Panax notoginseng 2 parts, Agrimonia pilosa 6 parts, and Palm carbon 7 parts; Prescription six: Euphorbia humifusa 15 parts, Sanguisorba officinalis carbon 8 parts, Sophora japonica 8 parts, Rubia cordifolia 8 parts, Biota orientalis 8 parts, Bletilla striata 4 parts, Panax notoginseng 1 part, Agrimonia pilosa 7 parts, and Palm carbon 8 parts.

4. A method for preparing the traditional Chinese medicine composition for treating active ulcerative colitis according to any one of claims 1-3, characterized in that, The raw materials are weighed according to the ratio, and 6-14 times the amount of water or 50%-90% ethanol is added for heating reflux extraction for 0.5-5 hours. The extraction is performed 1-3 times, and the filtrate is combined and concentrated at 40-90°C under reduced pressure. The concentrated solution is dried to obtain the product.

5. The method for preparing the traditional Chinese medicine composition for treating the active phase of ulcerative colitis according to claim 4, characterized in that, The method comprises the following steps: S1: Weigh the raw materials according to the ratio for standby; S2: Add 6-14 times the amount of water or 50%-90% ethanol to Euphorbia humifusa, Sanguisorba officinalis carbon, Sophora japonica, and Palm carbon for heating reflux extraction for 0.5-5 hours. The extraction is performed 1-3 times, and the filtrate is combined and concentrated at 40-90°C under reduced pressure for standby; S3: Add 6-14 times the amount of water or 50%-90% ethanol to Biota orientalis, Rubia cordifolia, Bletilla striata, Panax notoginseng, and Agrimonia pilosa for heating reflux extraction for 0.5-5 hours. The extraction is performed 1-3 times, and the filtrate is combined and concentrated at 40-90°C under reduced pressure for standby; S3: Combine the concentrated solutions 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 active phase of ulcerative colitis according to claim 5, characterized in that, Step S2 is to add 6-14 times the amount of water to the rehmannia, white mulberry root-bark, palm, and carbonized white mulberry root-bark, and reflux extract for 0.5-5 hours. Filter, add 6-14 times the amount of 50%-90% ethanol to the residue, and reflux extract for 0.5-5 hours. Filter, combine the extract, and concentrate under reduced pressure at 40-90°C to a density of 1.01-1.

20. Reserve.

7. The method for preparing the traditional Chinese medicine composition for treating the active phase of ulcerative colitis according to claim 5, characterized in that, Step S3 is to add 6-14 times the amount of 50%-90% ethanol to the cypress, madder, white pith, panax, and knotweed, and reflux extract for 0.5-5 hours. Filter, add 6-14 times the amount of water to the residue, and reflux extract for 0.5-5 hours. Filter, combine the extract, and concentrate under reduced pressure at 40-90°C to a density of 1.01-1.

20. Reserve.

8. A preparation for treating active ulcerative colitis, characterized by, The application further discloses a Chinese medicine composition for treating active ulcerative colitis, which comprises the Chinese medicine composition of any one of claims 1-3 and at least one excipient.

9. The preparation for treating ulcerative colitis in active phase 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 of any one of claims 1-3 in the preparation of a medicament for treating patients with diarrhea due to damp-heat in the large intestine.

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