Traditional Chinese medicine preparation for treating ulcerative colitis and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine preparation for treating ulcerative colitis and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine preparation is prepared from 10-30 parts of sargentgloryvine stem, 10-30 parts of mulberry leaf, 5-20 parts of sophora flower, 5-20 parts of lotus seed, 1-15 parts of chalk, 1-15 parts of cortex ailanthi, 5-20 parts of lily, 5-20 parts of radix pseudostellariae, 1-15 parts of white hyacinth bean, 5-20 parts of radix linderae and 5-20 parts of fructus aurantii, and has the effects of clearing away heat and toxic materials, relieving diarrhea with astringents, regulating qi activity of spleen and stomach and regulating qi and yin. The traditional Chinese medicine preparation disclosed by the invention can be used for remarkably improving the trend of weight loss and clinical symptoms of UC mice as well as the condition of colon shortening of the UC mice, repairing and improving the integrity of a colon tissue structure, remarkably inhibiting secretion of inflammatory factors IL-6, IL-1beta and TNF-alpha and improving the inflammatory condition of colon tissues, and has anti-inflammatory and anti-inflammatory effects. According to the traditional Chinese medicine preparation, the cure rate and the total effective rate of ulcerative colitis can be remarkably increased, symptoms such as stomachache, diarrhea, bloody purulent stool and tenesmus of patients are improved and relieved, the pain of the patients is relieved to a great extent, and the traditional Chinese medicine preparation can serve as a medicine for treating ulcerative colitis to be applied and popularized.

Description

Technical Field

[0001] The 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 proctitis and 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 repeated bloody stools with mucus, pus, diarrhea and abdominal pain, as well as pathological manifestations such as mucosal erythema, loss of normal vascular morphology, granularity, erosion, fragility, bleeding and ulceration, and a clear boundary between inflammatory and non-inflammatory intestines. In clinical practice, ulcerative colitis is often divided into primary, chronic recurrent, chronic persistent, and acute fulminant types, among which chronic recurrent ulcerative colitis is the most common. Epidemiology shows that the incidence of UC is increasing year by year and has gradually evolved into a global disease. UC patients who are in an inflammatory state for a long time are more likely to develop intestinal tumor diseases such as colorectal cancer.

[0003] At present, the etiology and pathogenesis of UC are not completely clear, but most people believe that it is related to factors such as immunity, genetics, infection, spirit and intestinal environment. Its onset is mainly due to immune cells, dendritic cells, imbalance of multiple cytokines and abnormal intracellular signal transduction, which lead to a series of pathological manifestations such as inflammation of the intestinal mucosa and submucosal layer, and intestinal flora imbalance. Therefore, Western medicine often uses antibacterial drug treatment, hormone therapy, immunosuppressants and other methods to treat UC, and surgical treatment is performed if there are surgical indications, but there are many adverse reactions, easy recurrence, increased drug resistance, and high costs. In terms of the prevention and treatment of UC, traditional Chinese medicine is based on the overall situation of the patient. It plays an important role in the initiation, aggravation and prevention of recurrence of the disease, and has a definite effect and obvious advantages. The present invention aims to provide a safe and effective Chinese medicine preparation with a definite effect that can significantly improve the clinical manifestations of patients with ulcerative colitis and reduce the recurrence rate. Summary of the invention

[0004] 1. Technical issues to be 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] (II) 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, which 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 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 Toona sinensis 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 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 Toona sinensis root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of white hyacinth bean, 15 parts of Linderae umbellatae, and 15 parts of Citrus aurantium.

[0011] The Chinese medicine preparation provided by the present invention is used for preparing medicine for treating ulcerative colitis. The Chinese medicine preparation is prepared into oral dosage forms medically acceptable to human body according to conventional preparation methods. The dosage forms include decoction, granules, oral liquid, pills, tablets and lyophilized powder.

[0012] Furthermore, the Chinese medicine pills for treating ulcerative colitis are prepared according to the following steps:

[0013] Weigh each raw material according to the above weight proportions, wash, soak with 4 times purified water for 40 minutes, then boil for 30 minutes, filter and collect the filtrate; add 3 times water to the filter residue and boil for 30 minutes again, filter and collect the filtrate; add 3 times water to the filter residue and boil for 30 minutes again, filter and collect the filtrate, dry and crush the filter residue into powder for later use; combine the filtrates for three times and concentrate them into a non-flowing paste; dry and crush the paste into powder and mix it evenly with the filter residue and medicinal powder, then add 5%-10% honey of the amount of Chinese medicinal powder and mix to make concentrated pills with a particle size of 0.2-0.4cm and a mass of 0.3-0.5g.

[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 carbuncle and abdominal pain, heat and 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 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 kidney and nourish the heart, and are mainly used for spleen deficiency, chronic diarrhea, loss of appetite, and insufficient kidney qi.

[0019] Chalk: It is a block or powder of sedimentary rock chalk, the main component of which is calcium carbonate, with small amounts of aluminum silicate, magnesium silicate, calcium phosphate, iron oxide, etc.; bitter, warm, enters the lung and kidney meridians; warms the middle, astringes the intestines, stops bleeding, and heals sores. It is used to treat nausea, diarrhea, vomiting blood, epistaxis, red and rotten eye strings, and ecthyma.

[0020] Chinese toon root bark: cold in nature, bitter and astringent. It has the effects of clearing away heat and dampness, astringing and stopping leucorrhea, stopping diarrhea and stopping bleeding. It is often used for leucorrhea, damp-heat diarrhea, chronic diarrhea, blood in the 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 due to fatigue and hemoptysis, restlessness and palpitations, insomnia and dreaminess, and mental confusion.

[0022] Pseudostellariae Radix: sweet, slightly bitter; neutral in nature, enters the spleen and lung meridians; has the effects of invigorating qi and strengthening the spleen, promoting body fluid and moistening the lungs. It is often used for spleen deficiency, fatigue, loss of appetite, weakness after illness, insufficient qi and yin, spontaneous sweating and thirst, and dry cough due to lung dryness.

[0023] White lentil: sweet, slightly warm; has the effects of strengthening the spleen and eliminating dampness, harmonizing the middle and relieving heat; used to treat spleen and stomach weakness, poor appetite and loose stools, excessive leucorrhea, vomiting and diarrhea due to summer heat and dampness, chest tightness and abdominal distension. Stir-fried lentil strengthens the spleen and eliminates dampness, and treats spleen deficiency diarrhea, excessive leucorrhea and other symptoms.

[0024] Lindera stalks: spicy in taste, 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 and 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 cold menstruation.

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

[0026] (III) Beneficial effects

[0027] The present invention starts with the etiology and pathogenesis of ulcerative colitis, follows the principle of TCM treatment based on syndrome differentiation, and uses a Chinese medicine composition for treating ulcerative colitis composed of scutellaria baicalensis, mulberry leaves, sophora japonica flowers, lotus seeds, chalk, Chinese toon root bark, lily, Pseudostellaria heterophylla, white lentils, lindera striata, and fructus aurantii. Ulcerative colitis often has the situation of intestinal heat toxicity accumulation and qi and blood stasis. The present invention uses scutellaria baicalensis, which has the effects of clearing away heat and detoxicating, promoting blood circulation and unblocking collaterals, as the main medicine to achieve the purpose of clearing intestinal heat toxicity and improving the local qi and blood stasis state of the intestine. 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, and can dispersing the heat evil in the body as a whole to prevent the 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 dampness and heat and dissipate heat evil; lotus seeds are used to nourish the spleen and stop diarrhea, benefit the kidneys and astringe the essence, and chalk astringes the intestines and stops diarrhea, warms the middle and drives away the cold, so as to regulate the spleen and stomach qi and improve the patient's diarrhea symptoms. The adjuvant Chinese toon root bark clears away heat and dampness, astringes the intestines and stops diarrhea, and assists the main and ministerial drugs to treat symptoms such as damp heat in the intestines and diarrhea; lily moistens the lungs and stops coughing, clears the heart and calms the mind, Pseudostellaria pubescens replenishes qi and strengthens the spleen, promotes fluid and moistens the lungs, and White Labiatae strengthens the spleen and eliminates dampness, and assists lotus seeds to regulate the spleen and stomach qi and strengthen the spleen; Linderae radix promotes qi and stops pain, warms the kidney and dispels cold, and Citrus aurantium regulates qi and relieves stagnation and dissipates bloating, and assists the main and ministerial drugs to regulate the intestinal qi and relieves symptoms such as abdominal distension and abdominal pain caused by poor qi. The present invention adopts multiple methods such as clearing away 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 internal environment of the body 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 has 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 effective rate of ulcerative colitis, significantly improve and relieve the patient's 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 drug for treating ulcerative colitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 The figure shows the effect of the Chinese medicine preparation of the present invention on the body weight and DAI score 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 are the effects of the Chinese medicinal preparation of the present invention on the colon length and colon histopathological score of UC mice, wherein 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 are 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] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are 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 Chinese toon root bark, 5 parts of lily, 5 parts of Pseudostellaria heterophylla, 4 parts of white hyacinth bean, 5 parts of Linderae umbellatae, and 5 parts of Citrus aurantium.

[0036] The Chinese medicine preparation is used to prepare a medicine for treating ulcerative colitis. The 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.

[0037] Example 2

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

[0039] Weigh the following raw materials according to the following weight proportions: 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, 20 parts of Pseudostellaria heterophylla, 15 parts of Lablab datura, 20 parts of Linderae rutaecarpa, 20 parts of Citrus aurantium, wash, soak with 4 times purified water for 40 minutes, then decoct for 30 minutes, filter and collect the filtrate; add 3 times water to the filter residue and decoct for 30 minutes again, filter and collect the filtrate; add 3 times water to the filter residue and decoct for 30 minutes again, filter and collect the filtrate, dry and grind the filter residue into powder for standby use; combine the filtrates for three times and concentrate them into a non-flowing paste; dry and grind the paste into powder and mix it evenly with the filter residue and medicine powder, then add 5% honey of the amount of Chinese medicine powder to mix, and 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 of 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 toona root barks, 6 parts of lily, 8 parts of pseudoginseng, 4 parts of white labiata, 6 parts of lindera stalks, and 6 parts of fructus aurantii.

[0043] Example 4

[0044] The difference between this embodiment and embodiment 1 is that the 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 Toona sinensis root bark, 10 parts of lily, 10 parts of Pseudostellaria heterophylla, 5 parts of Lablab cyrtonema, 10 parts of Linderae umbellatae, and 10 parts of Citrus aurantium.

[0045] Example 5

[0046] The difference between this embodiment and embodiment 1 is that the 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 hyacinth bean, 20 parts of Linderae umbellatae, and 20 parts of Citrus aurantium.

[0047] Example 6

[0048] The difference between this embodiment and embodiment 1 is that the 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 hyacinth bean, 18 parts of Linderae umbellatae, and 12 parts of Citrus aurantium.

[0049] Example 7

[0050] The difference between this embodiment and embodiment 1 is that the 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 Toona sinensis root bark, 12 parts of lily, 16 parts of Pseudostellaria heterophylla, 8 parts of Lablab cyrtonema, 14 parts of Linderae umbellatae, and 16 parts of Citrus aurantium.

[0051] Example 8

[0052] The difference between this embodiment and embodiment 1 is that the 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 Toona sinensis root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of White Labain, 15 parts of Linderae umbellatae, 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 a suitable temperature and humidity, 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] Weigh 18 parts of red vine, 26 parts of mulberry leaves, 14 parts of Sophora japonica, 14 parts of lotus seeds, 6 parts of chalk, 10 parts of Toona sinensis root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of Lablab datura, 15 parts of Linderae umbellatae, and 15 parts of Fructus Aurantii Immaturus according to the following proportions, wash, soak in 4 times purified water for 30 minutes, then boil over high heat for 30 minutes, repeat the boiling twice, combine the decoctions, concentrate to a Chinese medicine stock solution with a drug content of 1 g / mL, refrigerate, and set aside.

[0060] 1.3 Animal grouping, modeling and drug treatment

[0061] Before the experiment, the mice were adaptively fed for 1 week, and the mice were divided into 5 groups by random number table method, namely 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; blank group: normal feeding, free drinking of sterilized mineral water; the remaining 4 groups of mice freely drank sterilized mineral water containing 10g / L DSS for 7 days, and established a mouse ulcerative colitis (UC) model. During the modeling period, the mesalazine group was administered with mesalazine (0.5g / kg / d), the low-dose Chinese medicine preparation group and the high-dose Chinese medicine preparation group were gavaged with 1g / kg / d and 4g / kg / d of the Chinese medicine preparation of the present invention, and 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, feces and blood in the stool of the mice were recorded, and the DAI score was calculated according to the literature. The specific scoring criteria are shown in Table 1.

[0065] Table 1 DAI scoring criteria

[0066] Score (points) 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 amount of loose stools Small amount of blood in stool 3 10％～20％ Lots of loose stools Heavy blood in the stool 4 >20％ Watery stool 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 Colon histological pathological scoring

[0071] The inflamed colon tissue of mice was rinsed twice with precooled 0.9% sodium chloride injection, and 1 cm of rectal tissue close to the anus was soaked in paraformaldehyde for 24 hours, dehydrated, paraffin-embedded, sliced ​​and HE stained. A 0-3 point system was used to describe the severity of inflammation, and the three parameters were added together, with the highest score being 9. The scoring table is shown in Table 2.

[0072] Table 2 Colonic histopathological scores

[0073]

[0074]

[0075] 1.4.4 Detection of inflammatory factors in colon tissue

[0076] Pretreatment of colon tissue samples: accurately weigh the weight of mouse colon tissue, add PBS at a ratio of weight (g): volume (mL) = 1g:18mL, put in grinding beads, grind in a freezing grinder, centrifuge at 3500r / min at 4°C for 20min, and dispense 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 instructions of BCA and ELISA kits.

[0078] 1.5 Data Analysis

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

[0080] 2 Results

[0081] 2.1 Effects of the Chinese medicine preparation of the present invention on the body weight and DAI score 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 movements, loose stools, watery stools, and bloody stools; the DAI scores of the model group mice were significantly increased compared with the blank group (P<0.01). Compared with the model group, the weight loss trend of mice in each medication group was significantly weakened, and the DAI scores were significantly increased (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 medicine preparation of the present invention on colon length and histopathological scores of UC mice

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

[0085] Compared with the blank group, the histopathological scores of mice in the model group increased significantly, and the difference was statistically significant (P<0.0001). Compared with the model group, the CMDI scores of mice in the low-dose and high-dose groups of Chinese medicine preparations decreased significantly, and the difference was statistically significant (P<0.0001); the CMDI scores of mice in the mesalazine group decreased significantly (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 medicine 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, the 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 the 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 the 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] A total of 84 patients with ulcerative colitis admitted to our hospital from January 2024 to December 2024 were selected and divided into an observation group and a control group according to a random blind sampling method, with 42 cases in each group. There were 22 males and 20 females in the observation group, aged 18-50 (32.19±6.08) years old, and the course of disease was 1-6 (3.01±1.20) months. There were 24 males and 18 females in the control group, aged 20-55 (34.57±5.14) years old, and the course of disease was 1-6 (3.22±0.87) months. There was no significant difference in clinical data between the two groups (P>0.05), and they were comparable.

[0093] 1.2 Case selection criteria

[0094] Diagnostic criteria: (1) Western medicine diagnosis: According to the "Expert Consensus on the Diagnosis and Treatment of Ulcerative Colitis by Traditional Chinese and Western Medicine (2017)": In terms 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, with continuous or repeated attacks. Most of the courses of the disease are 3-5 months, and may be accompanied by extraintestinal manifestations such as liver, gallbladder, joints, and skin. Colonoscopy can reveal continuous diffuse colorectal lesions, local congestion and edema, disordered and blurred intestinal mucosal vascular texture, purulent secretions in some cases, and brittleness and bleeding in some cases. The surface of the intestinal mucosa 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, and some of them show disappearance, bluntness, or shallowness of colonic pouches. (2) TCM diagnosis: formulated according to the "Consensus on TCM Diagnosis and Treatment of Ulcerative Colitis": Main symptoms: ① Abdominal pain, usually before dawn; ② Continuous diarrhea, symptoms improve after diarrhea; ③ Continuous intestinal rumbling; ④ Mucus and blood in the stool. Secondary symptoms: ① General chills, cold limbs; ② Poor appetite, bland taste; ③ Weak waist and knees; ④ Like to eat hot drinks; ⑤ The patient's complexion is pale, the tongue is light red, the tongue coating is white, and the pulse is thin, deep and weak.

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

[0096] Exclusion criteria: (1) patients with various mental illnesses and difficulty cooperating 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 were unable to complete the entire course of treatment.

[0097] 1.3 Treatment methods

[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 control group children, 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 Toona sinensis root bark, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of Lablab lentiscus, 15 parts of Linderae umbellatae, 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 the Diagnosis and Treatment of Ulcerative Colitis with Traditional Chinese and Western Medicine (2017)", the patients' diarrhea, abdominal pain, bloody stools, and tenesmus were scored before and after treatment, specifically 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 indicate severe activity, 6-10 points indicate moderate activity, 3-5 points indicate mild activity; ≤2 points indicate 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 index70-95%; effective: efficacy index30-<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, count data were expressed as percentages, and inter-group comparisons were performed using the χ 2 Test, P < 0.05 was considered 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 Significant effect 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 the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. 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 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 toona root bark, 5-20 parts of lily, 5-20 parts of pseudoginseng, 1-15 parts of white hyacinth bean, 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 Chinese toon root barks, 10-20 parts of lilies, 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.

3. A Chinese medicine preparation for treating ulcerative colitis according to claim 1, characterized in that: The 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 Chinese toon root barks, 14 parts of lily, 18 parts of Pseudostellaria heterophylla, 10 parts of white hyacinth bean, 15 parts of Linderae umbellatae, and 15 parts of Citrus 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 an oral dosage form that is medically acceptable to humans according to a conventional preparation method. The dosage form includes water decoction, granules, oral liquid, pills, tablets, and freeze-dried powder.

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 weight parts, washing, soaking with 4 times purified water for 40 minutes, then boiling for 30 minutes, filtering and collecting the filtrate; adding 3 times water to the filter residue and boiling for 30 minutes, filtering and collecting the filtrate; adding 3 times water to the filter residue and boiling for 30 minutes, filtering and collecting the filtrate, drying and crushing the filter residue into powder for standby use; combining the filtrates for three times and concentrating them into a non-flowing paste; drying and crushing the paste into powder and mixing it evenly with the filter residue and medicine powder, then adding 5%-10% honey of the amount of Chinese medicine powder and mixing to prepare concentrated pills with a particle size of 0.2-0.4cm and a mass of 0.3-0.5g.

Images