A traditional Chinese medicine composition for treating chronic enteritis

Abstract

This invention provides a traditional Chinese medicine composition for treating chronic enteritis, relating to the field of traditional Chinese medicine pharmaceutical technology. The invention provides a traditional Chinese medicine composition for treating chronic enteritis, composed of Gentiana scabra, Sophora flavescens, Phellodendron chinense, Sparganium stoloniferum, Oroxylum indicum, Areca catechu, Paeonia lactiflora, Rosa laevigata, Hematite, Codonopsis pilosula, Magnolia officinalis, Raphanus sativus, and Prunus persica. This traditional Chinese medicine composition has the effects of clearing heat and drying dampness, strengthening the spleen and replenishing qi, promoting qi circulation and eliminating stagnation, astringing the intestines and stopping diarrhea, and promoting blood circulation and relieving pain. The purpose of this traditional Chinese medicine composition is to regulate the overall function of the body, enhance the spleen and stomach's digestive function, improve intestinal qi and blood circulation and water metabolism, thereby achieving the purpose of treating chronic enteritis. This traditional Chinese medicine composition can significantly alleviate weight loss, fecal condition, and hematochezia in a mouse model of DSS-induced chronic enteritis. It can significantly improve colonic shortening and pathological changes in colonic tissue in the DSS-induced chronic enteritis mouse model, restore damaged tissue structure, reduce the number and infiltration range of inflammatory cells, and has good anti-inflammatory effects. This traditional Chinese medicine composition has broad application prospects in the preparation of drugs for treating chronic enteritis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing technology, specifically to a traditional Chinese medicine composition for treating chronic enteritis. Background Technology

[0002] Chronic enteritis is a common gastroenterological disease. The main clinical symptoms include long-term, chronic, and recurrent diarrhea and abdominal pain, loss of appetite, abnormal bowel movements, and increased frequency of bowel movements. With changes and diversification in modern diets, the incidence of chronic enteritis is increasing. This disease often requires colonoscopy, which can detect pathological findings such as mucosal congestion or erosion, resulting in a high diagnostic rate. The etiology of this disease is complex, it is difficult to cure completely, and it has a high recurrence rate, and may even progress to intestinal tumors. Therefore, effectively controlling symptoms is of great significance for improving patients' quality of life.

[0003] Currently, clinical treatment often involves immunosuppressants and amino acid salicylic acid preparations to help patients control disease progression. However, the relapse rate is high after discontinuation of medication, increasing the difficulty of treatment. With the widespread clinical application of Traditional Chinese Medicine (TCM) in recent years, it has been used in the treatment of various diseases and has achieved significant therapeutic effects. TCM theory considers chronic enteritis to fall under the category of diarrhea, primarily affecting the small and large intestines, spleen, and stomach, while also being closely related to organs such as the kidneys and liver. When the body experiences emotional imbalance, mental stress, or liver qi stagnation, it is prone to spleen deficiency and dampness, metabolic disorders, and other conditions, leading to chronic enteritis. The application of TCM in the clinical treatment of digestive diseases is beneficial in further improving the overall efficacy of treatment, with fewer adverse reactions and higher safety. This invention aims to provide a TCM composition with a high efficacy rate in treating chronic enteritis and significantly improving patients' clinical symptoms. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating chronic enteritis.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] This invention provides a traditional Chinese medicine composition for treating chronic enteritis, the composition comprising the following raw materials in parts by weight: 5-20 parts of Gentiana scabra, 5-20 parts of Sophora flavescens, 5-20 parts of Phellodendron chinense, 1-15 parts of Sparganium stoloniferum, 1-15 parts of Oroxylum indicum, 1-15 parts of Areca catechu, 5-20 parts of Paeonia lactiflora, 5-20 parts of Rosa laevigata, 5-15 parts of Huangshizhi, 5-20 parts of Codonopsis pilosula, 5-20 parts of Magnolia officinalis, 1-15 parts of Raphanus sativus, and 1-10 parts of Prunus persica.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-20 parts of Gentiana scabra, 5-15 parts of Sophora flavescens, 10-20 parts of Phellodendron chinense, 5-15 parts of Sparganium stoloniferum, 5-15 parts of Oroxylum indicum, 1-10 parts of Areca catechu, 5-15 parts of Paeonia lactiflora, 10-20 parts of Rosa laevigata, 5-10 parts of Huangshizhi (a type of herb), 10-20 parts of Codonopsis pilosula, 5-15 parts of Magnolia officinalis, 5-15 parts of Raphanus sativus, and 1-6 parts of Prunus persica.

[0010] Furthermore, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 16 parts gentian root, 10 parts sophora root, 14 parts phellodendron bark, 10 parts sparganium rhizome, 10 parts oroxylum indicum, 8 parts areca nut, 12 parts white peony root, 16 parts rosehip, 8 parts yellow ochre, 15 parts codonopsis root, 12 parts magnolia bark, 10 parts radish seed, and 4 parts peach blossom.

[0011] This invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for treating chronic enteritis. The traditional Chinese medicine composition can be prepared into any oral dosage form acceptable to the human body according to conventional medical preparation methods. The dosage form includes oral liquid, decoction, granules, pills, freeze-dried powder, powder, etc.

[0012] The pharmacological effects of each medicinal material in the traditional Chinese medicine composition of this invention:

[0013] Gentian root: bitter in taste, cold in nature, enters the liver and gallbladder meridians; has the effects of clearing heat and drying dampness, purging liver and gallbladder fire; used for damp-heat jaundice, vulvar swelling and itching, leukorrhea, eczema and itching, red eyes due to liver fire, tinnitus and deafness, hypochondriac pain and bitter taste in the mouth, priapism, and infantile convulsions.

[0014] Sophora flavescens: Bitter, cold. It has the functions of clearing heat and drying dampness, killing parasites, and promoting diuresis. It is used for dysentery, hematochezia, jaundice and urinary retention, leukorrhea, vulvar swelling and itching, eczema, damp sores, pruritus, scabies, leprosy, and externally for trichomonal vaginitis.

[0015] Phellodendron bark: bitter and cold in nature; enters the kidney and bladder meridians; clears heat and dries dampness, drains fire and eliminates steaming heat, detoxifies and heals sores; used for damp-heat diarrhea, jaundice with red urine, leukorrhea and vulvar itching, painful and painful urination, beriberi with weakness, bone steaming fever, night sweats, seminal emission, sores and carbuncles, eczema and damp sores.

[0016] Sparganium rhizome: Its properties are bitter, pungent, and neutral. According to *Ben Cao Shi Yi* (Supplement to the Compendium of Materia Medica), it is sweet, neutral, and warm. Its meridians are liver and spleen. Functions and indications: It breaks up blood stasis and promotes qi circulation, eliminates stagnation and relieves pain, treats abdominal masses, qi and blood stagnation, abdominal pain, rib pain, amenorrhea, postpartum abdominal pain due to blood stasis, traumatic injuries, and hard sores and swellings. *Kai Bao Ben Cao* (Kai Bao Materia Medica) treats chronic abdominal masses and lumps.

[0017] Wood Orchid: Bitter, sweet, and cool in nature. It enters the lung, liver, and stomach meridians. It clears the lungs and soothes the throat, calms the liver and stomach. It is used for lung heat cough, sore throat, hoarseness, and liver and stomach pain. The *Compendium of Materia Medica Supplement* states: "It treats heart pain, liver pain, and damp heat in the lower body. Xiang Qiuzi also said that it can be applied to treat boils and carbuncles that fail to heal."

[0018] Areca nut: bitter, pungent, warm; enters the stomach and large intestine meridians; kills parasites, eliminates food stagnation, promotes qi circulation, promotes urination, and treats malaria; used for tapeworm disease, ascariasis, fasciolopsiasis, abdominal pain due to intestinal parasites, diarrhea due to food stagnation, tenesmus, edema, beriberi, and malaria.

[0019] White peony root: bitter, sour, slightly cold, enters the liver and spleen meridians; nourishes blood and softens the liver, relieves pain, astringes yin and stops sweating; mainly treats chest, abdominal and rib pain, diarrhea and abdominal pain, spontaneous sweating and night sweats, yin deficiency fever, irregular menstruation, metrorrhagia and leukorrhea.

[0020] Rosehip: It tastes sour, sweet, and astringent, and is neutral in nature; it enters the kidney, bladder, and large intestine meridians; it has the effects of consolidating essence and reducing urination, consolidating metrorrhagia and stopping leukorrhea, and astringing the intestines and stopping diarrhea; it is used for symptoms such as spermatorrhea, enuresis, frequent urination, metrorrhagia, leukorrhea, chronic diarrhea, and chronic dysentery; Rosehip mainly contains polysaccharides, triterpenes, tannins, flavonoids, and other effective chemical components; modern pharmacological studies have shown that Rosehip has antioxidant, immunomodulatory, hypoglycemic, lipid-lowering, antibacterial, anti-inflammatory, and antitumor effects, and also has good antipyretic, antidiarrheal, analgesic, and hemostatic effects.

[0021] Yellow clay: A medicinal mineral composed mainly of sphagnum mica or green kaolinite; bitter, neutral in nature, and enters the spleen and large intestine meridians; it has the effects of strengthening the spleen and astringing the intestines, stopping bleeding and promoting wound healing; it is mainly used to treat dysentery with purulent blood; carbuncles and malignant sores; and sores that are slow to heal.

[0022] Codonopsis pilosula: Sweet in taste, neutral in nature, and non-toxic, it enters the spleen and lung meridians; it has the effects of tonifying the middle energizer, replenishing qi, and promoting body fluid production. It is used for symptoms such as spleen and stomach weakness, deficiency of both qi and blood, fatigue, poor appetite, thirst, chronic diarrhea, and rectal prolapse. Codonopsis pilosula also has the effects of enhancing immunity, dilating blood vessels, lowering blood pressure, improving microcirculation, and enhancing hematopoietic function, thus enhancing the body's resistance.

[0023] Magnolia officinalis: bitter and pungent in taste; warm in nature; enters the spleen, stomach, lung, and large intestine meridians; dries dampness and eliminates phlegm, lowers qi and relieves fullness; used for dampness stagnation injuring the middle jiao, epigastric fullness and vomiting and diarrhea, food stagnation and qi stagnation, abdominal distension and constipation, phlegm retention and cough.

[0024] Radish seed: sweet in taste, neutral in nature, enters the lung and stomach meridians; used to relieve asthma and promote digestion. Treats cough with phlegm and wheezing, food stagnation and qi stagnation, chest tightness and abdominal distension, and tenesmus after diarrhea.

[0025] Peach blossom: bitter, neutral, with diuretic, blood-activating, and laxative effects; treats edema, beriberi, phlegm retention, stagnation, difficulty in urination and defecation, and amenorrhea.

[0026] (III) Beneficial Effects

[0027] This invention provides a traditional Chinese medicine composition for treating chronic enteritis, consisting of gentian root, sophora root, phellodendron bark, sparganium rhizome, oroxylum indicum, areca nut, white peony root, rosehip, ochre, codonopsis root, magnolia bark, radish seed, and peach blossom. The composition uses gentian root, sophora root, and phellodendron bark as the principal herbs. Gentian root clears heat and dries dampness, and purges liver and gallbladder fire; sophora root clears heat and dries dampness, kills parasites, and promotes urination; phellodendron bark clears heat and dries dampness, purges fire and detoxifies, reduces fever and eliminates steaming sensations. The three herbs work together to clear heat and dry dampness, primarily targeting damp-heat symptoms in the intestines. Ochre, sparganium rhizome, and peach blossom are used as assistant herbs. Ochre astringes the intestines and stops diarrhea, assisting the principal herbs in relieving diarrhea symptoms; sparganium rhizome breaks up blood stasis and promotes qi circulation, eliminates stagnation and relieves pain; peach blossom promotes urination and bowel movements, invigorates blood and removes blood stasis. Based on the heat-clearing and dampness-drying effects of the principal herbs, it disperses intestinal blood stasis and assists the principal herbs in improving intestinal inflammation. The formula also includes Codonopsis pilosula, Magnolia officinalis, Oroxylum indicum, Areca catechu, Paeonia lactiflora, Rosa laevigata, and Raphanus sativus as adjuvant herbs. Codonopsis pilosula strengthens the spleen and lungs, nourishes blood and generates fluids; Magnolia officinalis dries dampness, eliminates phlegm, and relieves abdominal distension; Oroxylum indicum soothes the liver and harmonizes the stomach; Areca catechu promotes qi circulation and eliminates stagnation; Paeonia lactiflora softens the liver, relieves pain, and alleviates spasms; Rosa laevigata astringes the intestines and stops diarrhea; and Raphanus sativus promotes digestion and relieves bloating. These herbs, along with the principal and assistant herbs, work together to clear heat and dry dampness, strengthen the spleen and replenish qi, promote qi circulation and eliminate stagnation, astringe the intestines and stop diarrhea, and invigorate blood and relieve pain. This herbal composition aims to regulate the body's overall function, enhance spleen and stomach function, improve intestinal blood circulation and fluid metabolism, thereby treating chronic enteritis.

[0028] The herbal composition of this invention can significantly alleviate weight loss, fecal condition, and hematochezia in a mouse model of DSS-induced chronic enteritis, demonstrating a significant therapeutic effect. It can significantly improve colonic shortening and pathological changes in colonic tissue in the DSS-induced chronic enteritis mouse model, restore damaged tissue structure, and reduce the number and extent of inflammatory cell infiltration. This herbal composition reduces the progression of inflammation in the DSS-induced chronic enteritis mouse model by downregulating the expression of pro-inflammatory factors (IL-1β and TNF-α) and upregulating the expression of anti-inflammatory factor (IL-10), exhibiting good anti-inflammatory effects. This herbal composition has broad application prospects in the preparation of drugs for treating chronic enteritis. Attached Figure Description

[0029] Figure 1 DAI scores were assigned to mice in each group; compared with the model group, **P<0.01, ***P<0.001.

[0030] Figure 2 The results of colon length measurement in mice of each group are shown in (A) and photographs of the colons (B); compared with the model group, **P<0.01.

[0031] Figure 3 The results of histopathological scoring of colon tissue in each group of mice are shown; compared with the model group, **P<0.01, ***P<0.001.

[0032] Figure 4The relative expression levels of inflammatory factors IL-1β (A), TNF-α (B), and IL-10 (C) in the colon tissue of mice in each group were compared with those in the model group. *P<0.05, **P<0.01, ***P<0.001. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of 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 some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating chronic enteritis, the composition comprising the following raw materials in parts by weight: 5 parts gentian root, 5 parts sophora root, 5 parts phellodendron bark, 3 parts sparganium rhizome, 3 parts oroxylum indicum, 3 parts areca nut, 5 parts white peony root, 5 parts rosehip, 5 parts yellow ochre, 5 parts codonopsis root, 5 parts magnolia bark, 3 parts radish seed, and 3 parts peach blossom.

[0036] The above-mentioned traditional Chinese medicine composition is used to prepare a drug for treating chronic enteritis. The traditional Chinese medicine composition can be prepared into any oral dosage form acceptable to the human body according to conventional medical preparation methods. The dosage form includes oral liquid, decoction, granules, pills, freeze-dried powder, powder, etc.

[0037] Example 2

[0038] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Gentiana scabra, 20 parts of Sophora flavescens, 20 parts of Phellodendron chinense, 15 parts of Sparganium stoloniferum, 15 parts of Oroxylum indicum, 15 parts of Areca catechu, 20 parts of Paeonia lactiflora, 20 parts of Rosa laevigata, 15 parts of Huangshizhi (a type of herb), 20 parts of Codonopsis pilosula, 20 parts of Magnolia officinalis, 15 parts of Raphanus sativus, and 10 parts of Prunus persica.

[0039] Example 3

[0040] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 8 parts of gentian root, 8 parts of sophora root, 6 parts of phellodendron bark, 3 parts of sparganium rhizome, 3 parts of oroxylum indicum, 5 parts of areca nut, 8 parts of white peony root, 8 parts of rosehip, 6 parts of yellow ochre, 8 parts of codonopsis root, 8 parts of magnolia bark, 4 parts of radish seed, and 3 parts of peach blossom.

[0041] Example 4

[0042] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts of gentian root, 15 parts of sophora root, 16 parts of phellodendron bark, 12 parts of sparganium rhizome, 10 parts of oroxylum indicum, 12 parts of areca nut, 16 parts of white peony root, 18 parts of rosehip, 12 parts of yellow ochre, 18 parts of codonopsis root, 16 parts of magnolia bark, 10 parts of radish seed, and 8 parts of peach blossom.

[0043] Example 5

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of gentian root, 5 parts of sophora root, 10 parts of phellodendron bark, 5 parts of sparganium rhizome, 5 parts of oroxylum indicum, 3 parts of areca nut, 5 parts of white peony root, 10 parts of rosehip, 5 parts of yellow ochre, 10 parts of codonopsis root, 5 parts of magnolia bark, 5 parts of radish seed, and 2 parts of peach blossom.

[0045] Example 6

[0046] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of gentian root, 15 parts of sophora root, 20 parts of phellodendron bark, 15 parts of sparganium rhizome, 15 parts of oroxylum indicum, 10 parts of areca nut, 15 parts of white peony root, 20 parts of rosehip, 10 parts of yellow ochre, 20 parts of codonopsis root, 15 parts of magnolia bark, 15 parts of radish seed, and 6 parts of peach blossom.

[0047] Example 7

[0048] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 14 parts of gentian root, 12 parts of sophora flavescens root, 12 parts of phellodendron bark, 8 parts of sparganium rhizome, 8 parts of oroxylum indicum root, 4 parts of areca nut, 10 parts of white peony root, 12 parts of rosehip, 6 parts of yellow ochre, 12 parts of codonopsis root, 10 parts of magnolia bark, 8 parts of radish seed, and 3 parts of peach blossom.

[0049] Example 8

[0050] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 16 parts of gentian root, 10 parts of sophora root, 14 parts of phellodendron bark, 10 parts of sparganium rhizome, 10 parts of oroxylum indicum, 8 parts of areca nut, 12 parts of white peony root, 16 parts of rosehip, 8 parts of yellow ochre, 15 parts of codonopsis root, 12 parts of magnolia bark, 10 parts of radish seed, and 4 parts of peach blossom.

[0051] Experimental Example 1

[0052] The anti-inflammatory effect of the traditional Chinese medicine composition of this invention on intestinal mucosal microvascular endothelial cells (RIMVECs)

[0053] 1 Method

[0054] 1.1 Preparation of LPS solution

[0055] Dilute LPS powder with high-glucose DMEM solution, mix thoroughly, prepare a 1 mg / mL solution, and freeze at -20°C. Take the 1 mg / mL LPS solution out of the freezer, thaw, shake to mix, dilute with high-glucose DMEM, prepare a 40 μg / mL LPS solution, and then add FBS and insulin injection solution to make their concentrations 3% and 0.27%, respectively.

[0056] 1.2 Preparation of test reagent solutions

[0057] Medicine 1: Gentian root 16 parts, Sophora flavescens 10 parts, Phellodendron bark 14 parts, Sparganium rhizome 10 parts, Oroxylum indicum 10 parts, Areca nut 8 parts, White peony root 12 parts, Rosa laevigata fruit 16 parts, Yellow ochre 8 parts, Codonopsis pilosula 15 parts, Magnolia officinalis 12 parts, Radish seed 10 parts, Peach blossom 4 parts

[0058] Medicine 2: Gentian root 16 parts, Phellodendron bark 14 parts, Sparganium rhizome 10 parts, Oroxylum indicum 10 parts, Areca nut 8 parts, Yellow ochre 8 parts, Codonopsis root 15 parts, Magnolia bark 12 parts, Radish seed 10 parts, Peach blossom 4 parts

[0059] Medicine 3: 10 parts Sophora flavescens, 10 parts Sparganium stoloniferum, 10 parts Oroxylum indicum, 8 parts Areca catechu, 12 parts Paeonia lactiflora, 16 parts Rosa laevigata, 8 parts Huangshizhi (a type of resin), 15 parts Codonopsis pilosula, 12 parts Magnolia officinalis.

[0060] Medicine 4: Gentian root 16 parts, Sophora flavescens 10 parts, Phellodendron bark 14 parts, White peony root 12 parts, Rosa laevigata 16 parts, Yellow ochre 8 parts, Codonopsis pilosula 15 parts, Magnolia officinalis 12 parts, Radish seed 10 parts, Peach blossom 4 parts

[0061] Medicine 5: Gentian root 16 parts, Sophora flavescens 10 parts, Phellodendron bark 14 parts, Sparganium rhizome 10 parts, Oroxylum indicum 10 parts, Areca nut 8 parts, White peony root 12 parts, Rosa laevigata fruit 16 parts, Radish seed 10 parts, Peach blossom 4 parts

[0062] Weigh each raw material according to the above weight proportions, add 4 times the amount of water and decoct twice, filter, combine the decoctions, and concentrate to a Chinese herbal medicine stock solution 1-5 with a drug content of 1g / mL (equivalent to 1g of raw drug per milliliter), sterilize, refrigerate and store for later use; when using, first prepare a test stock solution with a concentration of 25mg / mL using DMSO solvent, then dilute it with high-sugar DMEM to a drug concentration of 2.5mg / mL, mix well and add 3% FBS to obtain the test drug solution 1-5.

[0063] 1.3 Protective effect on LPS-induced RIMVECs cells

[0064] The cultured RIMVECs cells were cultured in complete culture medium at 10 4The cells were densely packed in 96-well plates and cultured in a cell culture incubator for 12 hours. The supernatant of each well was discarded, and the corresponding PLS solution and test drug 1-5 solution were added respectively. The blank control group was added with maintenance medium. Each group was set up with 6 replicates. After culturing in a cell culture incubator for 6 hours, the supernatant was collected for use. 100 μL of 10% CCK8 DMEM solution was added to the cells, and after standing at 37°C in the dark for 1.5 hours, the OD value was measured at 450 nm using a microplate reader, and the cell viability of RIMVECs was calculated.

[0065] Cell viability (%) = (OD) 试验 -OD 空白 ) / (OD 对照 -OD 空白 )×100%

[0066] 1.4 Detection of inflammatory factors in LPS-induced RIMVECs cells

[0067] The levels of TNF-α, IL-6, and IL-1β in cell supernatant were detected using ELISA.

[0068] 1.5 Data Analysis

[0069] Statistical analysis was performed using Prism 8.0, and one-way ANOVA was used for inter-group comparisons. Results are expressed as mean ± standard deviation. The results were analyzed using a t-test. P < 0.05 was considered statistically significant.

[0070] 2 Results

[0071] 2.1 Protective effect of the traditional Chinese medicine composition of the present invention on LPS-induced RIMVECs cells

[0072] The results are shown in Table 1. Compared with the blank control group, LPS caused significant damage to RIMVECs and significantly reduced cell viability. Compared with the positive control group, the cell viability of experimental groups 1-5 all showed varying degrees of increase, and the differences were significant (P<0.05). Among them, the cell viability of experimental group 1 reached 96.26%, which was significantly higher than that of experimental groups 2-5 (P<0.05).

[0073] Table 1. LPS-induced cell viability of RIMVECs under different drug treatments.

[0074]

[0075]

[0076] Note: The same lowercase letter on the shoulder indices indicates P>0.05; different lowercase letters on the shoulder indices indicate P<0.05.

[0077] 2.2 Effects of the herbal composition of the present invention on the secretion of inflammatory factors by LPS-induced RIMVECs cells

[0078] The results are shown in Table 2. Compared with the blank control group, LPS stimulation of RIMVECs cells significantly increased the expression of inflammatory factors (TNF-α, IL-6, IL-1β) in RIMVECs cells (P<0.05). Compared with the positive control group, under the action of test drugs 1-5, the expression of inflammatory factors (TNF-α, IL-6, IL-1β) in RIMVECs cells of experimental groups 1-5 decreased to varying degrees (P<0.05). Among them, the expression of inflammatory factors (TNF-α, IL-6, IL-1β) in RIMVECs cells of experimental group 1 was significantly lower than that in experimental groups 2-5 (P<0.05).

[0079] Table 2. Levels of inflammatory factors secreted by LPS-induced RIMVECs cells under different drug treatments.

[0080] Grouping TNF-α (pg / mL) IL-6 (pg / mL) IL-1β (pg / mL) Blank control group <![CDATA[30.02±5.03 a ]]> <![CDATA[24.16±2.74 a ]]> <![CDATA[32.39±4.09 a ]]> Positive control group <![CDATA[123.36±7.99 b ]]> <![CDATA[69.15±3.49 b ]]> <![CDATA[113.09±8.44 b ]]> Experimental group 1 <![CDATA[42.11±3.97 c ]]> <![CDATA[31.16±1.84 c ]]> <![CDATA[46.97±5.66 c ]]> Experimental group 2 <![CDATA[74.19±6.87 d ]]> <![CDATA[49.10±3.12 d ]]> <![CDATA[78.14±6.07 d ]]> Experimental group 3 <![CDATA[83.16±5.47 d ]]> <![CDATA[46.31±2.71 de ]]> <![CDATA[71.26±5.22 d ]]> Experimental group 4 <![CDATA[66.19±8.01 e ]]> <![CDATA[40.26±3.11 ef ]]> <![CDATA[62.18±3.74 e ]]> Experimental group 5 <![CDATA[58.92±4.77 e ]]> <![CDATA[38.48±5.06 f ]]> <![CDATA[57.19±4.89 e ]]>

[0081] Note: The same lowercase letter on the shoulder indices indicates P>0.05; different lowercase letters on the shoulder indices indicate P<0.05.

[0082] 3. Conclusion

[0083] The above results indicate that high concentrations of LPS can cause damage to RIMVECs cells and the development of inflammation. The test drugs 1-5 provided in this experiment all showed varying degrees of protective and anti-inflammatory effects against high-concentration LPS-induced cell damage. However, the components of the herbal composition of this invention (test drug 1) synergistically enhance each other, working together to achieve the best protective and anti-inflammatory effect against LPS-induced cell damage.

[0084] Experimental Example 2

[0085] Effects of the herbal composition of this invention on a mouse model of DSS-induced chronic enteritis

[0086] 1. Materials and Methods

[0087] 1.1 Laboratory Animals

[0088] Fifteen 6-8 week old SPF-grade male BALB / c mice were selected and housed in an SPF-grade environment, following a diurnal cycle, with suitable temperature and humidity maintained. The indoor temperature was 22-26℃ and the relative humidity was 50%-60%.

[0089] 1.2 Preparation of the herbal extract of this invention

[0090] Gentian root 16 parts, Sophora flavescens 10 parts, Phellodendron bark 14 parts, Sparganium rhizome 10 parts, Oroxylum indicum 10 parts, Areca nut 8 parts, White peony root 12 parts, Rosa laevigata fruit 16 parts, Yellow ochre 8 parts, Codonopsis pilosula 15 parts, Magnolia officinalis 12 parts, Radish seed 10 parts, Peach blossom 4 parts

[0091] 1.2 Animal grouping, model establishment, and drug administration

[0092] Before the experiment, mice were acclimatized for one week and then randomly divided into three groups of five mice each using a random number table. The healthy control group was fed normally and had free access to sterilized mineral water. The other two groups of mice had free access to sterilized mineral water containing 10g / LDS for seven days, followed by sterile distilled water for seven days. Two weeks constituted one cycle (three cycles in total) to establish a mouse model of chronic enteritis. The experimental group was given the original Chinese medicine extract of this invention (10g / kg·mouse) by gavage starting on the second day after the mice began drinking the DSS solution, until the end of the experiment.

[0093] 1.3 Observation Indicators

[0094] 1.3.1 Mouse body weight, fecal condition, and bloody stool

[0095] Mouse weight, fecal condition, and fecal blood loss were recorded, and the Disease Activity Index (DAI) was calculated using references. The specific scoring criteria were as follows:

[0096] Mouse weight: No weight loss is 0 points; weight loss of 1% to 5% is 1 point; weight loss of 5% to 10% is 2 points; weight loss of 10% to 20% is 3 points; weight loss of more than 20% is 4 points.

[0097] Stool: Normal stool is 0 points; soft stool is 1 point; wet and soft stool is 2 points; semi-loose stool is 3 points; loose stool is 4 points.

[0098] Blood in stool: 0 points for no blood in stool; 2 points for positive result; 4 points for pure blood in stool.

[0099] DAI = (weight score + stool characteristics score + bloody stool score) / 3, with DAI ranging from 0 (healthy) to 4 (most severe colitis symptoms).

[0100] 1.3.2 Colon length measurement

[0101] After treatment, the mice were euthanized by cervical dislocation. The intestinal tissue from the end of the cecum to the anus was separated, and the length from the anus to the rectum to the junction of the colon and cecum was measured.

[0102] 1.3.3 Colonic histological scoring

[0103] Inflamed colonic tissue from mice was rinsed twice with pre-cooled 0.9% sodium chloride injection. A 1cm section of rectal tissue near the anus was soaked in paraformaldehyde for 24 hours, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The severity of inflammation was described using a 0-3 scale, with the three parameters summed, and a maximum score of 9. The scoring table is shown in Table 3.

[0104] Table 3. Colonic tissue pathology scores

[0105]

[0106] 1.3.4 Detection of inflammatory factors in colon tissue

[0107] Total RNA was extracted from mouse colonic inflammation tissue using Trizol reagent. Quantitative PCR was performed strictly according to the manufacturer's protocol. Primer sequences are shown in Table 4.

[0108] Table 4 Primer sequences

[0109]

[0110] 1.4 Data Analysis

[0111] Statistical analysis was performed using Prism 8.0, and one-way ANOVA was used for inter-group comparisons. Results are expressed as mean ± standard deviation. The results were analyzed using a t-test. P < 0.05 was considered statistically significant.

[0112] 2 Results

[0113] 2.1 Effect of the herbal composition of the present invention on the DAI score of a mouse model of chronic enteritis

[0114] Compared with the healthy control group, mice that freely drank water containing DSS began to show significantly reduced food intake, decreased body weight, and loose stools on day 3. As time progressed, the model group mice exhibited lethargy, reduced food intake, and watery or even bloody stools. The experimental group mice also showed effects on body weight, fecal characteristics, and bloody stools. Compared with the healthy control group, the DAI score of the model group mice was significantly higher (P<0.001); compared with the model group, the DAI score of the experimental group mice was significantly lower (P<0.01). Results are as follows. Figure 1 As shown.

[0115] 2.2 Effects of the herbal composition of the present invention on colon length and histopathological score in a mouse model of chronic enteritis

[0116] Measurements of colon length in mice across different groups revealed that the colon length in the model group was significantly shorter than that in the healthy control group (P<0.01); compared to the model group, the colon length in the experimental group was significantly longer (P<0.01). Results are as follows... Figure 2 As shown.

[0117] The histopathological scores of the colon tissues of mice in each group showed that ( Figure 3 Compared with the healthy control group, the colon histopathological score of mice in the model group was significantly increased (P<0.001); compared with the model group, the colon histopathological score of mice in the experimental group was significantly decreased (P<0.01).

[0118] 2.3 Effects of the herbal composition of the present invention on inflammatory factors in the colonic tissue of a mouse model of chronic enteritis

[0119] Compared with the healthy control group, the relative expression levels of IL-1β and TNF-α inflammatory factors in the colonic tissue of the model group of chronic enteritis mice were significantly increased (P<0.001), and the relative expression level of IL-10 inflammatory factor was significantly decreased (P<0.01). Compared with the model group, the relative expression levels of IL-1β and TNF-α inflammatory factors in the colonic tissue of the experimental group of chronic enteritis mice were significantly decreased (P<0.001), and the relative expression level of IL-10 inflammatory factor was significantly decreased (P<0.05). These results indicate... Figure 4 As shown.

[0120] 3. Conclusion

[0121] The above results indicate that the herbal composition of this invention, administered via gavage, can significantly alleviate weight loss, fecal condition, and hematochezia in a mouse model of DSS-induced chronic enteritis, demonstrating a significant therapeutic effect. It can significantly improve colonic shortening and pathological changes in colonic tissue in the DSS-induced chronic enteritis mouse model, restore damaged tissue structure, and reduce the number and extent of inflammatory cell infiltration. Furthermore, the herbal composition of this invention reduces the progression of inflammation in the DSS-induced chronic enteritis mouse model by downregulating the expression of pro-inflammatory factors (IL-1β and TNF-α) and upregulating the expression of anti-inflammatory factor (IL-10), thus exhibiting good anti-inflammatory effects.

[0122] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic enteritis, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 5-20 parts of gentian root, 5-20 parts of sophora root, 5-20 parts of phellodendron bark, 1-15 parts of sparganium rhizome, 1-15 parts of oroxylum indicum, 1-15 parts of areca nut, 5-20 parts of white peony root, 5-20 parts of rosehip, 5-15 parts of ochre, 5-20 parts of codonopsis root, 5-20 parts of magnolia bark, 1-15 parts of radish seed, and 1-10 parts of peach blossom.

2. The traditional Chinese medicine composition for treating chronic enteritis as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10-20 parts of gentian root, 5-15 parts of sophora flavescens root, 10-20 parts of phellodendron bark, 5-15 parts of sparganium rhizome, 5-15 parts of oroxylum indicum root, 1-10 parts of areca nut, 5-15 parts of white peony root, 10-20 parts of rosa laevigata fruit, 5-10 parts of ochre, 10-20 parts of codonopsis root, 5-15 parts of magnolia bark, 5-15 parts of radish seed, and 1-6 parts of peach blossom.

3. The traditional Chinese medicine composition for treating chronic enteritis as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 16 parts gentian root, 10 parts sophora root, 14 parts phellodendron bark, 10 parts sparganium rhizome, 10 parts oroxylum indicum, 8 parts areca nut, 12 parts white peony root, 16 parts rosehip, 8 parts yellow ochre, 15 parts codonopsis root, 12 parts magnolia bark, 10 parts radish seed, and 4 parts peach blossom.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a drug for treating chronic enteritis, characterized in that, The traditional Chinese medicine composition is prepared into any one of the following forms: oral liquid, decoction, granules, pills, freeze-dried powder, or powder, according to conventional medical preparation methods.

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