A traditional Chinese medicine preparation for treating ulcerative colitis and its preparation method

Abstract

The present invention provides a kind of Chinese medicine preparation for treating ulcerative colitis and its preparation method, relate to the field of Chinese medicine pharmaceutical technology. The Chinese medicine preparation of the present invention is made of 10-30 parts of red cauliflower, 10-30 parts of mulberry leaves, 5-20 parts of sophora japonica flowers, 5-20 parts of lotus seeds, 1-15 parts of chalk, 1-15 parts of Chinese toon root bark, 5-20 parts of lily, 5-20 parts of pseudoginseng, 1-15 parts of white labiatae, 5-20 parts of lindera striata, and 5-20 parts of fructus aurantii, with the effects of clearing away heat and detoxifying, astringing the intestines and stopping diarrhea, regulating the spleen and stomach qi, and regulating qi and yin. The Chinese medicine preparation of the present invention can significantly improve the trend and clinical symptoms of weight loss in UC mice, as well as the situation of shortened colon in UC mice, can repair and improve the integrity of colon tissue structure, significantly inhibit the secretion of inflammatory factors IL-6, IL-1β and TNF-α, improve the inflammatory situation of colon tissue, and has anti-inflammatory and anti-inflammatory effects. The Chinese medicine preparation of the present invention can significantly improve the cure rate and total effective rate of ulcerative colitis, improve and relieve the patient's symptoms such as abdominal pain, diarrhea, bloody stools and tenesmus, and greatly reduce the patient's pain. The Chinese medicine preparation of the present invention can be promoted and applied as a medicine for treating ulcerative colitis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical preparation, and in particular to a traditional Chinese medicine preparation for treating ulcerative colitis and a preparation method thereof. Background Art

[0002] Ulcerative colitis (UC), also known as idiopathic colorectal inflammation or chronic nonspecific ulcerative colitis, is an inflammatory bowel disease of unknown etiology that occurs specifically in the rectum and colon. It is characterized by objective manifestations such as recurrent bloody and mucus-purulent stools, diarrhea, and abdominal pain, as well as pathological manifestations such as mucosal erythema, loss of normal vascular morphology and granularity, erosion, friability, bleeding, and ulceration, with a clear demarcation between inflamed and non-inflamed bowel. Clinically, UC is categorized into primary, chronic recurrent, chronic persistent, and acute fulminant forms, with chronic recurrent ulcerative colitis being the most common. Epidemiological studies have shown that the incidence of UC has been increasing annually, and it has gradually evolved into a global disease. UC patients who experience a long-term inflammatory state are more likely to develop intestinal neoplasia such as colorectal cancer.

[0003] Currently, the etiology and pathogenesis of ulcerative colitis (UC) are not fully understood, but are generally believed to be related to immune, genetic, infectious, psychiatric, and intestinal environmental factors. Its pathogenesis is primarily due to imbalances in immune cells, dendritic cells, multiple cytokines, and abnormal intracellular signaling, leading to a series of pathological manifestations, including inflammation of the intestinal mucosa and submucosa, and dysbiosis of the intestinal flora. Therefore, Western medicine often uses antimicrobial agents, hormone therapy, immunosuppressants, and, where indicated, surgical treatment. However, these treatments are associated with numerous adverse reactions, high recurrence rates, increased drug resistance, and high costs. Traditional Chinese medicine (TCM) treats UC based on a patient's overall condition, playing a crucial role in the onset, progression, and prevention of recurrence of the disease. It also offers significant advantages and demonstrated efficacy. The present invention aims to provide a safe, effective, and therapeutically proven TCM preparation that can significantly improve the clinical manifestations and reduce the recurrence rate of patients with ulcerative colitis. Summary of the Invention

[0004] (1) Technical problems solved

[0005] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine preparation for treating ulcerative colitis and a preparation method thereof.

[0006] (2) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] First, the present invention provides a traditional Chinese medicine preparation for treating ulcerative colitis. The traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 10-30 parts of red vine, 10-30 parts of mulberry leaves, 5-20 parts of Sophora japonica flowers, 5-20 parts of lotus seeds, 1-15 parts of chalk, 1-15 parts of Chinese toon root bark, 5-20 parts of lily, 5-20 parts of Pseudostellaria heterophylla, 1-15 parts of white hyacinth bean, 5-20 parts of Linderae umbellatae, and 5-20 parts of Citrus aurantium.

[0009] Furthermore, the traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 15-30 parts of red vine, 15-30 parts of mulberry leaves, 10-20 parts of Sophora japonica flowers, 10-20 parts of lotus seeds, 1-10 parts of chalk, 5-15 parts of Chinese toon root bark, 10-20 parts of lily, 10-20 parts of Pseudostellaria heterophylla, 5-15 parts of white hyacinth bean, 10-20 parts of Linderae umbellatae, and 10-20 parts of Citrus aurantium.

[0010] Furthermore, the Chinese medicine preparation is made from the following raw materials in parts by weight: 18 parts of red vine, 26 parts of mulberry leaves, 14 parts of Sophora japonica flowers, 14 parts of lotus seeds, 6 parts of chalk, 10 parts of Chinese toon root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of white lentils, 15 parts of Linderae umbellatae, and 15 parts of Citrus aurantium.

[0011] The traditional Chinese medicine preparation provided by the present invention is used to prepare a medicine for treating ulcerative colitis. The traditional Chinese medicine preparation is prepared into a medically acceptable oral dosage form for human body according to a conventional preparation method. The dosage form includes water decoction, granules, oral liquid, pills, tablets, and freeze-dried powder.

[0012] Furthermore, a Chinese medicine pill for treating ulcerative colitis is prepared according to the following steps:

[0013] The raw materials are weighed according to the above weight parts, washed, soaked in 4 times purified water for 40 minutes, then decocted for 30 minutes, and the filtrate is collected by filtration; 3 times water is added to the filter residue and decocted for 30 minutes, and the filtrate is collected by filtration; 3 times water is added to the filter residue and decocted for 30 minutes, and the filtrate is collected by filtration, and the filter residue is dried and crushed into powder for later use; the three filtrates are combined and concentrated into a non-flowing paste; the paste is dried and crushed into powder and mixed evenly with the filter residue and medicinal powder, and then 5%-10% of honey is added to the Chinese medicinal powder to make concentrated pills with a particle size of 0.2-0.4 cm and a mass of 0.3-0.5 g.

[0014] The pharmacological effects of each component in the Chinese medicine preparation of the present invention are as follows:

[0015] Red vine: also known as large blood vine, bitter in taste, neutral in nature, enters the large intestine and liver meridians, clears away heat and detoxifies, promotes blood circulation, dispels wind and relieves pain; used for intestinal abscesses and abdominal pain, heat-toxic sores, amenorrhea, dysmenorrhea, swelling and pain from falls, and rheumatic pain.

[0016] Mulberry leaves: bitter and sweet in taste, cold in nature; enter the lung and liver meridians; have the effects of dispersing wind-heat, clearing the lungs and moistening dryness, calming the liver and improving eyesight, cooling blood and stopping bleeding; used for wind-heat colds, the initial stage of febrile diseases, lung heat coughs, red and blurred eyes, etc.

[0017] Sophora japonica flower: bitter in taste, slightly cold in nature, enters the liver and large intestine meridians; has the effects of cooling blood and stopping bleeding, clearing the liver and purging fire; mainly treats intestinal wind, bloody stools, hemorrhoids, liver fire headache, red and swollen eyes and other symptoms.

[0018] Lotus seeds: sweet, astringent, neutral in nature; enter the spleen, kidney, and heart meridians, consolidate essence and stop leukorrhea, tonify the spleen and stop diarrhea, benefit the kidneys and nourish the heart, mainly used for spleen deficiency, long-term diarrhea, loss of appetite and insufficient kidney qi.

[0019] Chalk: This is a lump or powder of sedimentary rock chalk, primarily composed of calcium carbonate, with minor inclusions of aluminum silicate, magnesium silicate, calcium phosphate, and iron oxide. It is bitter and warming, entering the lung and kidney meridians. It warms the middle meridians, astringes the intestines, stops bleeding, and heals sores. It is used to treat nausea, diarrhea, hematemesis, epistaxis, red and ulcerated eyes, and ecthyma.

[0020] Chinese toon root bark: It is cold in nature, bitter and astringent in taste. It has the effects of clearing heat and dampness, astringing and stopping leucorrhea, stopping diarrhea, and stopping bleeding. It is commonly used for leucorrhea, damp-heat diarrhea, chronic diarrhea, bloody stool, and metrorrhagia.

[0021] Lily: sweet in taste, cold in nature, enters the heart and lung meridians; it has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind. Lily is often used to treat yin deficiency and dry cough, cough with blood due to fatigue, restlessness and palpitations, insomnia and dreaminess, and mental confusion.

[0022] Pseudostellariae Radix: Sweet with a slightly bitter taste; neutral in nature, enters the spleen and lung meridians; benefits from invigorating Qi and strengthening the spleen, promoting fluid production and moistening the lungs. It is commonly used for spleen deficiency, fatigue, loss of appetite, weakness after illness, Qi and Yin deficiency, spontaneous sweating, thirst, and dry cough due to lung dryness.

[0023] White lentils: Sweet and slightly warm in nature, they strengthen the spleen and eliminate dampness, harmonize the stomach, and relieve summer heat. They are used to treat spleen and stomach deficiency, poor appetite, loose stools, excessive vaginal discharge, vomiting and diarrhea due to summer heat and dampness, and chest tightness and abdominal distension. Stir-fried lentils strengthen the spleen and eliminate dampness, and treat spleen deficiency, diarrhea, and excessive vaginal discharge.

[0024] Lindera scabra: spicy in flavor, warm in nature, enters the lung, spleen, kidney, and bladder meridians; has the effects of promoting qi and relieving pain, warming the kidney and dispersing cold; used for cold-stagnation qi stagnation, chest and abdominal distension and pain, qi reversal and shortness of breath, bladder deficiency and coldness, enuresis and frequent urination, hernia pain, and abdominal pain due to menstrual cold.

[0025] Citrus aurantium: Bitter, pungent, sour, slightly cold, enters the spleen and stomach meridians; has the effects of regulating qi, relieving fullness, and relieving stagnation and distension. It is commonly used to treat qi stagnation in the chest and flanks, distension and pain, indigestion, phlegm and fluid retention, and sagging organs.

[0026] (3) Beneficial effects

[0027] The present invention addresses the etiology and pathogenesis of ulcerative colitis and adheres to the principles of TCM syndrome differentiation and treatment. A Chinese medicinal composition comprising Caulis Sargentodoxae, mulberry leaves, Sophora japonica flowers, lotus seeds, chalk, Chinese toon root bark, lily bulb, Pseudostellaria chinensis, Lablab datura, Linderae striata, and Fructus Aurantii Immaturus is formulated for the treatment of ulcerative colitis. Ulcerative colitis is often associated with accumulation of intestinal heat and toxins, as well as qi and blood stasis. The present invention utilizes Caulis Sargentodoxae, which has the effects of clearing heat and toxins, and promoting blood circulation and unblocking meridians, as the main ingredient to clear intestinal heat and toxins and improve local qi and blood stasis in the intestines. Mulberry leaves, Sophora japonica flowers, lotus seeds and chalk are used as assistant medicines. Mulberry leaves have the effect of dispersing wind-heat, clearing the lungs and moistening dryness, dispersing heat evil in the body as a whole, and preventing heat evil from further aggravating intestinal lesions; Sophora japonica flowers are good at clearing the liver and purging fire, cooling blood and stopping bleeding. While achieving effective hemostasis of intestinal bleeding, they work together with mulberry leaves to clear damp heat and dissipate heat evil; assisted by lotus seeds to nourish the spleen and stop diarrhea, benefit the kidneys and astringe essence, chalk to astringe the intestines and stop diarrhea, warm the middle and dispel cold, so as to regulate the spleen and stomach qi and improve the patient's diarrhea symptoms. The adjuvant Chinese toon root bark clears heat and dampness, astringes the intestines and stops diarrhea, and assists the monarch and ministerial drugs in treating symptoms such as intestinal damp-heat and diarrhea; lily moistens the lungs and relieves coughs, clears the heart and calms the mind; Pseudostellaria pubescens replenishes qi and strengthens the spleen, promotes fluid production and moistens the lungs; white lentils strengthen the spleen and eliminate dampness, and assists lotus seeds in regulating the spleen and stomach qi and strengthening the spleen; Linderae radix promotes qi and relieves pain, warms the kidney and dispels cold; Citrus aurantium regulates qi and relieves fullness, promotes stagnation and relieves bloating, and assists the monarch and ministerial drugs in regulating the intestinal qi and alleviating symptoms such as abdominal distension and abdominal pain caused by sluggish qi. The present invention adopts multiple methods such as clearing heat and detoxifying, astringing the intestines and stopping diarrhea, regulating the spleen and stomach qi, and regulating qi and yin, aiming to improve the intestinal symptoms of patients with ulcerative colitis and regulate the body's internal environment to achieve the purpose of treating the disease.

[0028] The results of animal experiments show that the Chinese medicine preparation of the present invention can significantly improve the weight loss trend of UC mice, improve the clinical symptoms and colon shortening of UC mice, repair and improve the integrity of colon tissue structure, significantly inhibit the secretion of inflammatory factors IL-6, IL-1β and TNF-α, improve the inflammation of colon tissue, and have anti-inflammatory and anti-inflammatory effects.

[0029] In clinical application, the Chinese medicine preparation of the present invention can significantly improve the cure rate and total effectiveness rate of ulcerative colitis, significantly improve and relieve the patient's abdominal pain, diarrhea, bloody stools, tenesmus and other symptoms, and greatly reduce the patient's pain. The Chinese medicine preparation of the present invention can be promoted and applied as a drug for treating ulcerative colitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 The figure shows the effects of the Chinese medicinal preparation of the present invention on the body weight and DAI scores of UC mice, wherein A is the change rate of mouse body weight (%); B is the DAI score. Compared with the model group, ***P<0.001.

[0031] Figure 2The figures show the effects of the traditional Chinese medicine preparation of the present invention on the colon length and colon histopathological score of UC mice, where A is the colorectal length; B is the colon histopathological score; compared with the model group, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0032] Figure 3 The figures show the effects of the Chinese medicinal preparation of the present invention on the inflammatory factors IL-1β (A), IL-6 (B), and TNF-α (C) in the colon tissue of UC mice; compared with the model group, *P<0.05, **P<0.01, ***P<0.001. DETAILED DESCRIPTION

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0034] Example 1

[0035] A traditional Chinese medicine preparation for treating ulcerative colitis is prepared from the following raw materials in parts by weight: 10 parts of red vine, 10 parts of mulberry leaves, 5 parts of sophora japonica flowers, 5 parts of lotus seeds, 2 parts of chalk, 2 parts of toon root bark, 5 parts of lily, 5 parts of pseudoginseng, 4 parts of white hyacinth bean, 5 parts of lindera stalk, and 5 parts of aurantium.

[0036] The traditional Chinese medicine preparation is used to prepare a medicine for treating ulcerative colitis. The traditional Chinese medicine preparation is prepared into a medically acceptable oral dosage form according to a conventional preparation method. The dosage form includes water decoction, granules, oral liquid, pills, tablets, and freeze-dried powder.

[0037] Example 2

[0038] The Chinese medicine pills for treating ulcerative colitis are prepared according to the following steps:

[0039] The following raw materials were weighed according to the following weight ratios: 30 parts of red vine, 30 parts of mulberry leaves, 20 parts of Sophora japonica flowers, 20 parts of lotus seeds, 15 parts of chalk, 15 parts of Chinese toon root bark, 20 parts of lily bulbs, 20 parts of Pseudostellaria heterophylla, 15 parts of Lablab damiana, 20 parts of Linderae rutaecarpa, and 20 parts of Citrus aurantium, washed, soaked in 4 times purified water for 40 minutes, then decocted for 30 minutes, and the filtrate was collected by filtration; 3 times water was added to the filter residue and decocted for 30 minutes, and the filtrate was collected by filtration; 3 times water was added to the filter residue and decocted for 30 minutes, and the filtrate was collected by filtration, and the filter residue was dried and ground into powder for later use; the filtrates were combined and concentrated into a non-flowing paste; the paste was dried and ground into powder and mixed evenly with the filter residue and medicinal powder, and then 5% honey of the amount of the Chinese medicinal powder was added and mixed to prepare concentrated pills with a particle size of 0.2-0.4 cm and a mass of 0.3-0.5 g.

[0040] Example 3

[0041] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made from the following raw materials in parts by weight:

[0042] 12 parts of red cauline, 14 parts of mulberry leaves, 8 parts of sophora japonica flowers, 8 parts of lotus seeds, 3 parts of chalk, 4 parts of toon root barks, 6 parts of lilies, 8 parts of pseudoginseng, 4 parts of white labiatae, 6 parts of lindera stalks, and 6 parts of fructus aurantii.

[0043] Example 4

[0044] The difference between this embodiment and Example 1 is that the traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 15 parts of red vine, 15 parts of mulberry leaves, 10 parts of Sophora japonica flowers, 10 parts of lotus seeds, 3 parts of chalk, 5 parts of Chinese toon root bark, 10 parts of lily, 10 parts of Pseudostellaria heterophylla, 5 parts of white hyacinth bean, 10 parts of Linderae scutellariae, and 10 parts of Citrus aurantium.

[0045] Example 5

[0046] The difference between this embodiment and Example 1 is that the traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 30 parts of red vine, 30 parts of mulberry leaves, 20 parts of Sophora japonica flowers, 20 parts of lotus seeds, 10 parts of chalk, 15 parts of Chinese toon root bark, 20 parts of lily, 20 parts of Pseudostellaria heterophylla, 15 parts of white lentils, 20 parts of Linderae strychnifolia, and 20 parts of Citrus aurantium.

[0047] Example 6

[0048] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 22 parts of red vine, 24 parts of mulberry leaves, 18 parts of Sophora japonica flowers, 12 parts of lotus seeds, 4 parts of chalk, 12 parts of Chinese toon root bark, 16 parts of lily, 12 parts of Pseudostellaria heterophylla, 12 parts of white lentils, 18 parts of Linderae strychnifolia, and 12 parts of Citrus aurantium.

[0049] Example 7

[0050] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 26 parts of red vine, 20 parts of mulberry leaves, 14 parts of Sophora japonica flowers, 16 parts of lotus seeds, 5 parts of chalk, 8 parts of Chinese toon root bark, 12 parts of lily, 16 parts of Pseudostellaria heterophylla, 8 parts of white lentils, 14 parts of Linderae strychnifolia, and 16 parts of Citrus aurantium.

[0051] Example 8

[0052] The difference between this embodiment and Example 1 is that the traditional Chinese medicine preparation is made of the following raw materials in parts by weight: 18 parts of red vine, 26 parts of mulberry leaves, 14 parts of Sophora japonica flowers, 14 parts of lotus seeds, 6 parts of chalk, 10 parts of Chinese toon root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of white lentils, 15 parts of Linderae strychnifolia, and 15 parts of Citrus aurantium.

[0053] Test Example 1

[0054] Effect of the Chinese medicine composition of the present invention on the DSS-induced chronic enteritis mouse model

[0055] 1 Materials and Methods

[0056] 1.1 Experimental Animals

[0057] Twenty-five 6-week-old SPF male Kunming mice were selected and housed in an SPF environment, following the circadian cycle and maintaining an appropriate temperature and humidity environment, with an indoor temperature of 22-26°C and a relative humidity of 50%-60%.

[0058] 1.2 Preparation of the Chinese medicine preparation of the present invention

[0059] According to the following proportions, weigh 18 parts of red vine, 26 parts of mulberry leaves, 14 parts of Sophora japonica flowers, 14 parts of lotus seeds, 6 parts of chalk, 10 parts of Chinese toon root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of Lablab damiana, 15 parts of Linderae striata, and 15 parts of Citrus aurantium, wash them, soak them in 4 times purified water for 30 minutes, then decoct them over high heat for 30 minutes, repeat the decoction twice, combine the decoctions, concentrate them to a traditional Chinese medicine stock solution with a drug content of 1 g / mL, refrigerate them, and set aside.

[0060] 1.3 Animal grouping, modeling, and drug treatment

[0061] Before the experiment, mice were adaptively fed for 1 week and then randomly divided into 5 groups: blank group, model group, mesalazine group, low-dose Chinese medicine preparation group, and high-dose Chinese medicine preparation group, with 5 mice in each group. The blank group was fed normally and had free access to sterile mineral water. The remaining 4 groups of mice had free access to sterile mineral water containing 10g / L DSS for 7 days. A mouse ulcerative colitis (UC) model was established. During the modeling period, the mesalazine group was administered mesalazine (0.5g / kg / d). The low-dose and high-dose Chinese medicine preparation groups were gavaged with 1g / kg / d and 4g / kg / d of the Chinese medicine preparation of the present invention, respectively. The blank group and the model group were gavaged with the same amount of ultrapure water. Each group was administered once a day for 7 consecutive days.

[0062] 1.4 Observation indicators

[0063] 1.4.1 Mouse weight, feces, and blood in stool

[0064] The weight, fecal status, and blood in the stool of the mice were recorded, and the Disease Activity Index (DAI) was calculated according to the literature. The specific scoring criteria are shown in Table 1.

[0065] Table 1 DAI scoring criteria

[0066] Score (points) Degree of weight loss Stool form blood in the stool 0 0-1％ Normal morphology No blood in stool 1 1％～5％ Slightly loose stools Mild blood in stool 2 5％～10％ Small amounts of loose stools Small amounts of blood in the stool 3 10％～20％ Large amounts of loose stools Heavy blood in the stool 4 >20％ Watery stools Pure blood in stool

[0067] DAI score = (weight loss score + stool form score + blood in stool score) / 3

[0068] 1.4.2 Colon length measurement

[0069] After the treatment, the mice were killed by cervical dislocation, the intestinal tissue from the end of the cecum to the anus was separated, and the length from the anorectum to the junction of the colon and cecum was measured.

[0070] 1.4.3 Colonic histological pathological scoring

[0071] Inflamed colonic tissue from mice was rinsed twice with pre-chilled 0.9% sodium chloride injection. A 1 cm section of rectal tissue proximal to the anus was immersed in paraformaldehyde for 24 hours, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin. The severity of inflammation was described using a 0-3 point scale, with the sum of the three parameters, for a maximum score of 9. The scoring table is shown in Table 2.

[0072] Table 2 Colon histopathological scores

[0073]

[0074]

[0075] 1.4.4 Detection of inflammatory factors in colonic tissue

[0076] Colon tissue sample pretreatment: Accurately weigh the mouse colon tissue, add PBS at a ratio of weight (g): volume (mL) = 1 g: 18 mL, place grinding beads, grind in a cryo-grinder, centrifuge at 3500 rpm for 20 min at 4°C, and aliquot the supernatant into EP tubes to obtain colon tissue homogenate.

[0077] The total protein content in colon homogenate and the contents of IL-6, IL-1β and TNF-α in plasma and colon tissue homogenate were detected according to the BCA and ELISA kit instructions.

[0078] 1.5 Data Analysis

[0079] Statistical analysis was performed using Prism 8.0. One-way analysis of variance was used for comparisons between groups. The results are expressed as mean ± standard deviation. The data were analyzed using the t-test. P < 0.05 was considered statistically significant.

[0080] 2 Results

[0081] 2.1 Effects of the Chinese herbal preparation of the present invention on body weight and DAI scores of UC mice

[0082] Compared with the blank group mice, the body weight of the model group mice decreased significantly during the experiment (P<0.01), and the symptoms gradually became more severe, with lethargy, slow movement, loose stools, watery stools, and bloody stools; the DAI scores of the model group mice increased significantly compared with the blank group (P<0.01). Compared with the model group, the weight loss trend of the mice in each drug-treated group was significantly weakened, and the DAI scores increased significantly (P<0.01); among them, the DAI scores of the low-dose and high-dose groups of the Chinese medicine preparation of the present invention were significantly lower than those of the mesalazine group. The results show that the Chinese medicine preparation of the present invention can significantly improve the weight loss trend of UC mice and improve the clinical symptoms of UC mice, and the effect is better than mesalazine. The results are as follows Figure 1 shown.

[0083] 2.2 Effects of the Chinese herbal preparation of the present invention on colon length and histopathological scores in UC mice

[0084] Compared with the blank group, the colorectal length of the mice in the model group was significantly reduced (P<0.0001). Compared with the model group, the colorectal length of the mice in each drug-treated group increased to varying degrees, among which the mesalazine group and the low-dose Chinese medicine preparation group showed significant differences compared with the model group (P<0.05), and the high-dose Chinese medicine preparation group showed extremely significant differences compared with the model group (P<0.01). Figure 2 As shown in A.

[0085] Compared with the blank group, the histopathological scores of the mice in the model group were significantly increased, and the difference was statistically significant (P<0.0001). Compared with the model group, the CMDI scores of the mice in the low-dose and high-dose groups of the Chinese medicine preparation were significantly reduced, and the difference was statistically significant (P<0.0001); the CMDI scores of the mice in the mesalazine group were significantly reduced (P<0.001). Figure 2 As shown in B.

[0086] The above results indicate that the Chinese medicine preparation of the present invention can significantly improve the shortening of the colon in UC mice, repair and improve the integrity of the colon tissue structure, and improve the inflammation of the colon tissue.

[0087] 2.3 Effects of the Chinese herbal preparation of the present invention on inflammatory factors in colon tissue of UC mice

[0088] Compared with the blank group, the inflammatory factors IL-6, IL-1β and TNF-α in the colon tissue of the mice in the model group were significantly increased or decreased (P<0.05, P<0.001); compared with the model group, the inflammatory factor IL-1β in the colon tissue of the mice in the mesalazine group, low-dose and high-dose Chinese medicine preparation groups were significantly decreased (P<0.05), the inflammatory factor IL-6 in the colon tissue of the mice in the mesalazine group and high-dose Chinese medicine preparation group were significantly decreased (P<0.05), the inflammatory factor TNF-α in the colon tissue of the mice in the mesalazine group and high-dose Chinese medicine preparation group were significantly decreased (P<0.01), and the inflammatory factor TNF-α in the colon tissue of the mice in the low-dose Chinese medicine preparation group was significantly decreased (P<0.05). Figure 3 The above results show that the Chinese medicine preparation of the present invention has significant anti-inflammatory and anti-inflammatory effects on UC mice.

[0089] Test Example 2

[0090] 1 Materials and Methods

[0091] 1.1 Clinical Data

[0092] Methods: 84 patients with ulcerative colitis admitted to our hospital between January and December 2024 were randomly divided into an observation group and a control group, with 42 patients in each group. The observation group included 22 males and 20 females aged 18-50 years (32.19 ± 6.08) with a disease course of 1 to 6 months (3.01 ± 1.20). The control group included 24 males and 18 females aged 20-55 years (34.57 ± 5.14) with a disease course of 1 to 6 months (3.22 ± 0.87). There was no statistically significant difference in clinical data between the two groups (P > 0.05), indicating comparability.

[0093] 1.2 Case selection criteria

[0094] Diagnostic criteria: (1) Western medicine diagnosis: According to the "Consensus of Experts on Diagnosis and Treatment of Ulcerative Colitis in Traditional Chinese and Western Medicine (2017)": From the perspective of symptoms, the main symptoms are abdominal pain, diarrhea, and tenesmus. Some patients may have mucus, pus, and blood in the stool, which may be accompanied by various systemic discomforts and may be persistent or recurrent. Most patients have a course of 3-5 months and may be accompanied by extraintestinal manifestations such as liver, gallbladder, joints, and skin. Colonoscopy can reveal continuous and diffuse colorectal lesions. Under the microscope, local congestion and edema can be seen. The intestinal mucosal vascular texture is disordered and blurred. Some patients may have purulent secretions and some patients may be brittle and bleeding. The intestinal mucosa surface is rough and granular. In some severe cases, obvious multiple diffuse ulcers or erosions can be seen. Bridge-shaped mucosa or pseudopolyps can be seen. In some cases, the colon pouch disappears, becomes blunt, or becomes shallow. (2) Traditional Chinese Medicine Diagnosis: Based on the "Consensus on Diagnosis and Treatment of Ulcerative Colitis in Traditional Chinese Medicine": Main symptoms: ① Abdominal pain, usually occurring before dawn; ② Continuous diarrhea, which improves after diarrhea; ③ Continuous bowel sounds; ④ Bloody stools with mucus. Secondary symptoms: ① General chills and cold limbs; ② Poor appetite and bland taste; ③ Weakness and fatigue in the waist and knees; ④ Prefers hot drinks; ⑤ The patient's complexion is pale, the tongue is light red, the tongue coating is white, and the pulse is weak and deep.

[0095] Inclusion criteria: (1) patients with two main symptoms and one secondary symptom (or one main symptom plus two secondary symptoms); (2) patients and their families were informed of the study and voluntarily signed the consent form.

[0096] Exclusion criteria: (1) Patients with various mental illnesses who are difficult to cooperate with researchers; (2) Patients with abdominal pain, diarrhea, and bloody stools caused by other diseases; (3) Patients with severe heart and lung diseases; (4) Patients who are unable to complete the entire course of treatment.

[0097] 1.3 Treatment

[0098] Control group: mesalazine enteric-coated tablets, 1 g / time, 3 times a day, for 4 consecutive weeks.

[0099] Observation group: On the basis of the children in the control group, the children were given the Chinese medicine decoction of the present invention, specifically: 18 parts of red vine, 26 parts of mulberry leaves, 14 parts of Sophora japonica flowers, 14 parts of lotus seeds, 6 parts of chalk, 10 parts of Chinese toon root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of white lentils, 15 parts of Linderae striata, and 15 parts of Citrus aurantium. All the pieces were provided by the hospital's Chinese medicine pharmacy, decocted in conventional water, 1 dose per day, taken twice a day in the morning and evening, for 4 consecutive weeks.

[0100] 1.4 Observation indicators and methods

[0101] TCM symptom score: According to the "Expert Consensus on Diagnosis and Treatment of Ulcerative Colitis by Traditional Chinese and Western Medicine (2017)", the patients' diarrhea, abdominal pain, bloody stools, and tenesmus were scored before and after treatment, specifically as severe (9 points), severe (6 points), mild (3 points), and normal (0 points).

[0102] Mayo Activity Index Score: Refer to the "Consensus on Diagnosis and Treatment of Ulcerative Colitis in Traditional Chinese Medicine", 11-12 points are severe activity, 6-10 points are moderate activity, 3-5 points are mild activity; ≤2 points are symptom relief.

[0103] 1.5 Criteria for determining efficacy

[0104] According to the "Expert Consensus on the Diagnosis and Treatment of Ulcerative Colitis with Traditional Chinese and Western Medicine (2017)", the efficacy index = (TCM symptom score before treatment - TCM symptom score after treatment) / TCM symptom score before treatment × 100%.

[0105] Clinical cure: efficacy index > 95%; marked effect: efficacy index 70-95%; effective: efficacy index 30-<70%; ineffective: efficacy index <30%. Total effective rate = (clinical cure + marked effect + effective) / total number of cases × 100%

[0106] 1.6 Statistical methods

[0107] SPSS 21.0 statistical software was used to express measurement data as mean ± standard deviation. Non-independent sample t-test was used between groups, paired sample t-test was used within groups, and count data were expressed as percentages. The chi-square test was used for comparison between groups. 2 Test, P < 0.05 indicates that the difference is statistically significant.

[0108] 2 Results

[0109] 2.1 TCM symptom scores and Mayo activity index scores of the two groups of patients before and after treatment

[0110] As shown in Table 3, before treatment, there was no significant difference in the TCM symptom scores and Mayo activity index scores between the two groups (P>0.05); compared with before treatment, the TCM symptom scores and Mayo activity index scores of the two groups decreased significantly (P<0.05); among them, after treatment, the TCM symptom scores and Mayo activity index scores of the observation group were significantly lower than those of the control group (P<0.05).

[0111] Table 3 TCM symptom scores and Mayo activity index scores of the two groups of patients before and after treatment

[0112]

[0113] Note: Within this group, compared with before treatment, *P<0.05; after treatment, compared with the control group, # P<0.05

[0114] 2.2 Clinical efficacy of the two groups

[0115] As shown in Table 4, the clinical cure rate of the observation group was 28.57%, and the total effective rate was 100%; the clinical cure rate of the control group was only 9.52, the ineffective rate was 19.05%, and the total effective rate was 80.95%; the clinical efficacy of the observation group was significantly better than that of the control group.

[0116] Table 4 Clinical efficacy of the two groups [n (%)]

[0117] Grouping Number of cases cure efficient Significantly effective invalid Total effective control group 42 4(9.52) 12(28.57) 18(48.57) 8(19.05) 34(80.95) Observation Group 42 12(28.57) 22(52.38) 10(23.81) 0(0.00) 42(100)

[0118] 3 Conclusion

[0119] The above results show that the Chinese medicine preparation of the present invention can significantly improve the cure rate and total effective rate of ulcerative colitis, can significantly improve and relieve the clinical symptoms of patients such as abdominal pain, diarrhea, bloody stools and tenesmus, and greatly reduce the pain of patients. The Chinese medicine preparation of the present invention can be promoted and applied as a drug for the treatment of ulcerative colitis.

[0120] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A Chinese medicine preparation for treating ulcerative colitis, characterized in that: The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 10-30 parts of red vine, 10-30 parts of mulberry leaves, 5-20 parts of sophora japonica flowers, 5-20 parts of lotus seeds, 1-15 parts of chalk, 1-15 parts of toon root barks, 5-20 parts of lilies, 5-20 parts of pseudoginseng, 1-15 parts of white lentils, 5-20 parts of lindera stalks, and 5-20 parts of fructus aurantii.

2. A Chinese medicine preparation for treating ulcerative colitis according to claim 1, characterized in that The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 15-30 parts of red vine, 15-30 parts of mulberry leaves, 10-20 parts of sophora japonica flowers, 10-20 parts of lotus seeds, 1-10 parts of chalk, 5-15 parts of toon root barks, 10-20 parts of lilies, 10-20 parts of pseudoginseng, 5-15 parts of white lentils, 10-20 parts of lindera stalks, and 10-20 parts of fructus aurantii.

3. A Chinese medicine preparation for treating ulcerative colitis according to claim 1, characterized in that The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 18 parts of red vine, 26 parts of mulberry leaves, 14 parts of sophora japonica flowers, 14 parts of lotus seeds, 6 parts of chalk, 10 parts of toon root barks, 14 parts of lily, 18 parts of pseudoginseng, 10 parts of white lentils, 15 parts of lindera stalks, and 15 parts of aurantium.

4. Use of the Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of a medicament for treating ulcerative colitis, characterized in that: The Chinese medicine preparation is prepared into oral dosage forms that are medically acceptable to humans according to conventional preparation methods. The dosage forms include water decoctions, granules, oral liquids, pills, tablets, and freeze-dried powders.

5. The method for preparing the Chinese medicine preparation according to any one of claims 1 to 3, characterized in that: The Chinese medicine preparation is a Chinese medicine pill, which is prepared specifically according to the following steps: weighing each raw material according to the above-mentioned parts by weight, washing, soaking with 4 times purified water for 40 minutes, then decocting for 30 minutes, filtering and collecting the filtrate; adding 3 times water to the filter residue and decocting for 30 minutes again, filtering and collecting the filtrate; adding 3 times water to the filter residue and decocting for 30 minutes again, filtering and collecting the filtrate, drying and crushing the filter residue into powder for standby use; combining the three filtrates and concentrating them into a non-flowing paste; drying and crushing the paste into powder and uniformly mixing it with the filter residue and medicinal powder, then adding 5%-10% of honey in the amount of the Chinese medicine powder and mixing to prepare concentrated pills with a particle size of 0.2-0.4 cm and a mass of 0.3-0.5 g.

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