A traditional Chinese medicine composition for treating intestinal inflammation, a preparation method and application thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating intestinal inflammation, which comprises, by weight, 27-33 grams of earth-anchoring herb, 27-33 grams of dandelion, 8-10 grams of Chinese plum pit charred, 8-10 grams of white arisaema, 13-17 grams of Japanese knotweed, and 27-33 grams of lotus node charred. The traditional Chinese medicine composition for treating intestinal inflammation is prepared by mixing the above-mentioned raw materials, adding 400 ml of water, boiling, continuing to decoct for 30 minutes, filtering to obtain medicinal liquid, adding 400 ml of water to the residue, boiling, continuing to decoct for 30 minutes, filtering to obtain medicinal liquid, and combining the medicinal liquids obtained by two times of extraction. The traditional Chinese medicine composition for treating intestinal inflammation is used for treating ulcerative colitis of the type of heat-toxin damage and blood stasis in intestinal collaterals, and has the effects of clearing heat and resolving toxin, resolving blood stasis, and cooling blood to stop bleeding.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating intestinal inflammation, its preparation method, and its application. Background Technology

[0002] Heat toxin damage and stagnation in the intestinal tract can cause various symptoms, such as acute exacerbations of ulcerative colitis, acute hemorrhagic enteritis, and acute exacerbations of other digestive system diseases. Symptoms include significant abdominal pain, increased frequency of diarrhea, bloody or purulent stools (more bloody than white, or entirely bloody and stale), yellowish-brown and foul-smelling stools, burning sensation in the anus, scanty and dark urine, thirst with a preference for cold drinks, a red tongue with a thin yellow or slightly greasy coating, and a slippery and rapid or floating and rapid pulse.

[0003] For this type of disease, there is a lack of effective traditional Chinese medicines in the current technology. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for treating intestinal inflammation, its preparation method, and its application. It can be used to treat ulcerative colitis caused by heat toxicity and intestinal stasis, and has the effects of clearing heat and detoxifying, regulating the intestines, removing blood stasis, cooling blood, and stopping bleeding.

[0005] To solve the above-mentioned technical problems, the present invention specifically provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating intestinal inflammation, wherein, by weight, the formulation of the traditional Chinese medicine composition includes at least the following: 27-33 grams of Euphorbia humifusa, 27-33 grams of Taraxacum mongolicum, 8-10 grams of charred Prunus mume, 8-10 grams of Bletilla striata, 13-17 grams of Agrimonia pilosa, and 27-33 grams of charred Nelumbo nucifera rhizome.

[0006] Preferably, the formula of the traditional Chinese medicine composition, based on parts by weight, is as follows: 30g of Euphorbia humifusa, 30g of Taraxacum mongolicum, 9g of charred Prunus mume, 9g of Bletilla striata, 15g of Agrimonia pilosa, and 30g of charred Nelumbo nucifera rhizome.

[0007] Preferably, the formula of the traditional Chinese medicine composition, based on parts by weight, is as follows: 27g of Euphorbia humifusa, 27g of Taraxacum mongolicum, 8g of charred Prunus mume, 8g of Bletilla striata, 13g of Agrimonia pilosa, and 27g of charred Nelumbo nucifera rhizome.

[0008] Preferably, the formula of the traditional Chinese medicine composition, based on parts by weight, is as follows: 33g of Euphorbia humifusa, 33g of Taraxacum mongolicum, 10g of charred Prunus mume, 10g of Bletilla striata, 17g of Agrimonia pilosa, and 33g of charred Nelumbo nucifera rhizome.

[0009] Preferably, the formula of the traditional Chinese medicine composition further includes, by weight, one or any combination of stir-fried Coptis chinensis, stir-fried Paeonia lactiflora, and Pulsatilla chinensis.

[0010] Preferably, the formula of the traditional Chinese medicine composition further includes, by weight, one or any of the following: stir-fried Saposhnikovia divaricata, dried tangerine peel, and stir-fried Atractylodes macrocephala.

[0011] In a second aspect of the present invention, a method for preparing a traditional Chinese medicine composition for treating intestinal inflammation is provided. According to the formula of the traditional Chinese medicine composition, all the traditional Chinese medicine raw materials are mixed and 400ml of water is added. After boiling over high heat, the mixture is decocted for 30 minutes and then filtered to extract the medicinal liquid. Add 400ml of water to the dregs, bring to a boil over high heat, and continue to simmer for 30 minutes. Filter to extract the liquid. Combine the extracts from the two extractions.

[0012] In a third aspect of the present invention, there is an application of a traditional Chinese medicine composition for treating intestinal inflammation, wherein the traditional Chinese medicine composition for treating intestinal inflammation is used to treat ulcerative colitis of the heat-toxin injury and blood stasis type, and has the effects of clearing heat and detoxifying, regulating the intestines, removing blood stasis, cooling blood and stopping bleeding.

[0013] Compared with the prior art, the present invention has the following advantages: This invention can treat ulcerative colitis caused by heat toxin damage and intestinal stasis, and has good effects of clearing heat and detoxifying, regulating the intestines, removing blood stasis, cooling blood and stopping bleeding.

[0014] This traditional Chinese medicine composition is used to treat ulcerative colitis caused by heat toxicity and blood stasis in the intestinal tract. It has the effects of clearing heat and detoxifying, regulating the intestines, removing blood stasis, cooling blood, and stopping bleeding.

[0015] Euphorbia humifusa has a bitter and pungent taste, and is neutral in nature. It enters the liver and large intestine meridians and has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding. Euphorbia humifusa also has the effect of regulating blood and qi. Dandelion has a bitter taste and is cold in nature. It enters the liver and stomach meridians and has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules. The combination of the two enhances the effects of clearing heat, detoxifying and regulating the intestines.

[0016] Ume plum has the effects of astringing the lungs and intestines, promoting body fluid production and expelling roundworms; when charred, it can treat hematochezia, metrorrhagia, and other bleeding disorders. Bletilla striata has the effects of astringing and stopping bleeding, reducing swelling and promoting tissue regeneration. Agrimonia pilosa has the effects of astringing and stopping bleeding, stopping dysentery, and detoxifying. Charred lotus root nodes can both astringe and stop bleeding, and also dissipate blood stasis, possessing the characteristic of stopping bleeding without leaving blood stasis. The combination of these four herbs focuses on stopping bleeding, cooling the blood, resolving blood stasis, and detoxifying. The entire formula, when used together, can clear heat, detoxify, regulate the intestines, resolve blood stasis, cool the blood, and stop bleeding. Detailed Implementation

[0017] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and 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.

[0018] This invention provides a traditional Chinese medicine composition for treating intestinal inflammation, wherein, by weight, the formulation of the traditional Chinese medicine composition includes at least: 27-33 grams of Euphorbia humifusa, 27-33 grams of Taraxacum mongolicum, 8-10 grams of charred Prunus mume, 8-10 grams of Bletilla striata, 13-17 grams of Agrimonia pilosa, and 27-33 grams of charred Nelumbo nucifera rhizome.

[0019] Euphorbia humifusa has a bitter and pungent taste, and is neutral in nature. It enters the liver and large intestine meridians and has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding. Euphorbia humifusa also has the effect of regulating blood and qi. Dandelion has a bitter taste and is cold in nature. It enters the liver and stomach meridians and has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules. The combination of the two enhances the effects of clearing heat, detoxifying and regulating the intestines.

[0020] Ume plum has the effects of astringing the lungs and intestines, promoting body fluid production and expelling roundworms; when charred, it can treat hematochezia, metrorrhagia, and other bleeding disorders. Bletilla striata has the effects of astringing and stopping bleeding, reducing swelling and promoting tissue regeneration. Agrimonia pilosa has the effects of astringing and stopping bleeding, stopping dysentery, and detoxifying. Charred lotus root nodes can both astringe and stop bleeding, and also dissipate blood stasis, possessing the characteristic of stopping bleeding without leaving blood stasis. The combination of these four herbs focuses on stopping bleeding, cooling the blood, resolving blood stasis, and detoxifying. The entire formula, when used together, can clear heat, detoxify, regulate the intestines, resolve blood stasis, cool the blood, and stop bleeding.

[0021] This traditional Chinese medicine composition is used to treat ulcerative colitis caused by heat toxicity and blood stasis in the intestinal tract. It has the effects of clearing heat and detoxifying, regulating the intestines, removing blood stasis, cooling blood, and stopping bleeding. The Chinese medicine name obtained is Dijinwubai Decoction. Example 1:

[0022] The formula for the traditional Chinese medicine composition is as follows: 30g of Euphorbia humifusa, 30g of Taraxacum mongolicum, 9g of charred Prunus mume, 9g of Bletilla striata, 15g of Agrimonia pilosa, and 30g of charred Nelumbo nucifera rhizome. Example 2:

[0023] The formula for the traditional Chinese medicine composition is as follows: 27g of Euphorbia humifusa, 27g of Taraxacum mongolicum, 8g of charred Prunus mume, 8g of Bletilla striata, 13g of Agrimonia pilosa, and 27g of charred Nelumbo nucifera rhizome. Example 3:

[0024] The formula for the traditional Chinese medicine composition is as follows: 33g of Euphorbia humifusa, 33g of Taraxacum mongolicum, 10g of charred Prunus mume, 10g of Bletilla striata, 17g of Agrimonia pilosa, and 33g of charred Nelumbo nucifera rhizome.

[0025] The preparation method is as follows: according to the formula of the Chinese herbal composition, mix all the Chinese herbal raw materials, add 400ml of water, bring to a boil over high heat, continue to decoct for 30 minutes, and filter to extract the medicinal liquid; Add 400ml of water to the dregs, bring to a boil over high heat, and continue to simmer for 30 minutes. Filter to extract the liquid. Combine the extracts from the two extractions.

[0026] Many digestive tract diseases are caused by dietary factors, external pathogens, or constitutional factors. The initial pathogenesis is often due to internal damp-heat, stagnation of qi and blood, impaired transmission, obstruction of the large intestine, stagnation of qi, accumulation of heat and toxicity, damage to the membranes and collaterals, resulting in bloody and purulent diarrhea. Prolonged diarrhea is most likely to damage the spleen, leading to spleen deficiency, qi deficiency and damage to yang. With prolonged illness, the spleen becomes weak and the liver becomes overactive. At the same time, the chronic depletion of qi and blood gradually worsens. Qi deficiency leads to weak blood circulation, and blood deficiency leads to sluggish blood flow, resulting in blood stasis, heat, scorching, damage to body fluids and obstruction of collaterals, causing the disease to recur.

[0027] Following the principle of "treating the symptoms in urgent cases and addressing the root cause in chronic cases," and adhering to Ye Tianshi's idea that "entering the blood may cause blood loss and movement, so it is necessary to cool the blood and disperse blood stasis," this treatment targets the root cause of heat toxin damage and stagnation in the intestinal tract. It organically combines methods of clearing heat and detoxifying with stopping bleeding and removing blood stasis. By clearing heat and detoxifying and cooling the blood, the heat is cleared, preventing the blood from burning body fluids and causing blood stasis. By dispersing blood stasis, the heat toxin loses its attachment and does not bind with the blood stasis, making it difficult to clear and resolve. Blood flows when it is warm, and when it is cool, it can follow the meridians, making the blood vessels unobstructed and stopping the reckless bleeding.

[0028] The two methods combined work synergistically to clear heat and detoxify, regulate the intestines, cool the blood, remove blood stasis, and stop bleeding. This formula focuses on acute attacks of diseases caused by heat toxins and blood stasis in the intestinal tract. The herb *Euphorbia humifusa* is particularly important in the *Euphorbia humifusa* decoction, as intestinal diseases are often accompanied by qi stagnation. *Euphorbia humifusa* not only clears heat and detoxifies, cools the blood, and stops bleeding, but also benefits qi regulation, thus regulating the intestines and removing blood stasis. The charred *Prunus mume* and charred *Lotus rhizome* not only enhance the hemostatic effect but also promote the production of yin fluids.

[0029] Dijinwubai Decoction targets the pathological mechanism of heat-toxin damage and intestinal stagnation. Its formula is based on clearing heat and detoxifying, resolving blood stasis and stopping bleeding, and its efficacy is consistent with the patient's condition. Clinically, this formula can be flexibly modified according to the specific symptoms. It can be used not only to treat acute exacerbations of gastrointestinal diseases, but also for various internal medicine systems, as well as diseases in gynecology, andrology, surgery, dermatology, and ENT, achieving satisfactory results.

[0030] The following specific clinical data is provided: Mr. Zhang, male, 35 years old, works in the information technology industry. Chief complaint: Blood and mucus in stool for more than 3 weeks. Three weeks ago, after drinking alcohol and eating barbecue, the patient developed loose stools, 5-6 times a day, accompanied by abdominal pain and diarrhea, without significant tenesmus or rectal pressure. The stool contained blood and mucus, dark red in color, in moderate quantity. He has a history of ulcerative colitis for more than 2 years. His appetite is fair, he sleeps slightly late but is generally well, urination is normal, and he has no other significant discomfort. His tongue is dark red with a thin yellow coating, and his pulse is wiry and slippery.

[0031] Previous auxiliary examinations: Colonoscopy showed ulcerative colitis. Stool routine examination: Red blood cells 10-15 / Hp, white blood cells 3-5 / Hp.

[0032] Diagnosis: Ulcerative colitis (acute phase); Syndrome differentiation: Damp-heat accumulation in the intestines, heat and blood stasis intertwined, damaging the intestinal collaterals.

[0033] Example 1 is preferred, in which a traditional Chinese medicine composition for treating intestinal inflammation is modified.

[0034] Prescription: 30g of Euphorbia humifusa, 30g of Taraxacum mongolicum, 9g of charred Prunus mume, 9g of Bletilla striata, 15g of Agrimonia pilosa, and 30g of charred Nelumbo nucifera rhizome.

[0035] 7 doses. One dose per day, taken twice daily while warm.

[0036] During the follow-up visit, the patient reported that all symptoms had improved after taking the medication. Recently, the patient had 3 to 4 bowel movements per day, which were not well-formed, or contained a small amount of dark red blood and mucus, and experienced slight night sweats. The tongue was pale red with a thin coating, and the pulse was wiry.

[0037] This formula can be used for various bleeding symptoms in the middle and lower jiao (middle burner and lower abdomen). As long as the diagnosis is accurate and the symptoms are due to heat-toxin injury, blood heat with blood stasis, etc., it can be applied. However, in clinical use, other factors should be considered.

[0038] If there is also internal damp-heat, stir-fried Coptis chinensis, stir-fried peony root, and Pulsatilla chinensis can be added.

[0039] For cases with concurrent liver stagnation and spleen deficiency, stir-fried Saposhnikovia divaricata, dried tangerine peel, and stir-fried Atractylodes macrocephala can be added.

[0040] If there is also deficiency of yin, Zengye Decoction (containing Rehmannia glutinosa, Scrophularia ningpoensis, and Ophiopogon japonicus) can be combined with other herbs.

[0041] In clinical practice, this formula, with modifications, is often used to treat acute exacerbations of hemorrhagic gastritis, duodenal ulcers, ulcerative colitis, hemorrhoids, and other hemorrhagic digestive system diseases with good results.

[0042] The following application examples further illustrate the clinical efficacy of Dijinwubai Decoction in treating ulcerative colitis (UC) of the heat-toxin stagnation type and its effect on improving patients' conditions.

[0043] Ulcerative colitis (UC) is a chronic, nonspecific intestinal disease of unknown etiology characterized by continuous, diffuse inflammation of the colorectal mucosa, and its global incidence continues to rise. The main features of UC are persistent or recurrent diarrhea, bloody mucus stools, abdominal pain, tenesmus, and in severe cases, systemic symptoms such as fever, anemia, and weight loss. Some patients may also experience extraintestinal manifestations such as joint pain and skin lesions. Bloody mucus is the most common symptom of UC, presenting in approximately 90% of patients.

[0044] Commonly used Western medicines clinically include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, biological agents, small molecule agents, etc. However, at present, some patients still have poor efficacy, drug dependence, recurrence of the disease, etc. In recent years, more and more traditional Chinese medicine studies have explored the potential of traditional Chinese medicine in the treatment of UC. Traditional Chinese medicine believes that the pathological changes in the active stage of UC lie in the invasion of damp-heat pathogens into the intestines, which combine with qi and blood, resulting in qi stagnation and blood stasis, and the accumulation of heat into toxins. The dampness, heat, stasis, and toxins are mutually bound in the intestines. Therefore, clinical treatment needs to closely follow the pathogenesis, with the core principles of clearing heat and detoxifying, promoting blood circulation to remove stasis and stop bleeding. And Dijin Wubai Decoction has the effects of clearing heat and detoxifying, regulating the intestines, promoting blood circulation to remove stasis, cooling blood and stopping bleeding. This application uses Dijin Wubai Decoction as a drug in the treatment of UC with heat-toxin stasis type, and demonstrates its clinical efficacy and improvement effect on patients through specific data.

[0045] Application Example 1: I. Subject Data and Judgment Criteria 1. Subject data: Forty patients with UC of heat-toxin stasis type who visited Tongxiang Traditional Chinese Medicine Hospital from January 2024 to December 2025 were selected and divided into two groups according to the random number table method, namely the control group and the observation group, with 20 patients in each group.

[0046] In the control group, there were 12 males and 8 females. The age was 20 - 59 years old, with an average age of (33.67 ± 7.26) years.

[0047] In the observation group, there were 11 males and 9 females. The age was 18 - 56 years old, with an average age of (34.25 ± 6.38) years.

[0048] There was no significant difference in the gender and age of the two groups of patients (P > 0.05).

[0049] 2. Diagnostic criteria: The Western medicine diagnostic criteria were formulated according to "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 · Xi'an)". There were clinical symptoms such as persistent or recurrent diarrhea, mucus purulent bloody stools, accompanied by abdominal pain, tenesmus, etc.; under endoscopy, mucosal congestion, edema, granular changes, easy bleeding, multiple erosions or ulcers were seen; pathological examination showed infiltration of inflammatory cells in the lamina propria, crypt abscess, and structural disorder. The traditional Chinese medicine diagnosis referred to the syndrome differentiation norms of the syndrome of excessive heat-toxin in "Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Ulcerative Colitis (2023)" and combined with clinical practice. <00001​​3. Inclusion criteria: ① Meets both the Western medicine diagnostic criteria for UC and the TCM diagnostic criteria for heat-toxin stagnation syndrome; ② Age 18-60 years; ③ No serious underlying diseases or mental illnesses, and possesses independent behavioral capacity; ④ Normal cognitive function, willing to participate in this study and sign an informed consent form; ⑤ Not taking other medications that may affect the observation of efficacy during the study period.

[0052] 4. Exclusion criteria: ① Patients with various malignant tumors or other serious systemic diseases; ② Patients with complications such as massive bleeding, intestinal perforation, or intestinal obstruction; ③ Patients aged <18 years or >60 years; ④ Women who are trying to conceive, pregnant, or breastfeeding; ⑤ Patients who are allergic to the test drug or any of its components.

[0053] 5. Exclusion and Dropout Criteria: Exclusion Criteria: ① Patients found to be ineligible for inclusion after enrollment; ② Patients with poor treatment adherence who failed to follow the treatment protocol; ③ Patients receiving other related treatments concurrently. Dropout Criteria: ① Patients who voluntarily withdrew due to adverse reactions; ② Patients who changed medications on their own, failed to follow medical advice, or failed to attend follow-up appointments on time, or were lost to follow-up; ③ Patients who completed the trial but whose dosage was less than 50% of the prescribed dosage.

[0054] 6. Treatment methods: Patients in the control group were given oral mesalazine extended-release tablets (Ferring International Center SA, H20181183) 1g four times a day for eight weeks.

[0055] In addition to the above treatment, the patients in the observation group received a decoction of *Euphorbia humifusa* and *Bletilla striata*, composed of: 30g of *Euphorbia humifusa*, 30g of dandelion, 9g of charred *Prunus mume*, 9g of *Bletilla striata*, 15g of *Agrimonia pilosa*, and 30g of charred *Nelumbo nucifera*. One dose was taken daily, decocted with an appropriate amount of water for 40 minutes, yielding 400mL of liquid. This was taken twice daily, 200mL each time, in the morning and evening, for 8 consecutive weeks.

[0056] 7. Observation Indicators: ① Disease Score. The modified Mayo Criterion was used for evaluation, consisting of 4 items, each scored from 0 to 3 points. Higher scores indicated more severe disease. ② Inflammatory Marker Assessment. Fasting venous blood samples were collected from both groups of patients before and after treatment to detect the expression levels of tumor necrosis factor-α (TNF-α) and erythrocyte sedimentation rate (ESR). Stool samples were collected from both groups of patients before and after treatment to detect the level of fecal calprotectin (FC). ③ Traditional Chinese Medicine Syndrome Score. Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)" published in 2002, the primary symptoms (sudden bloody or purulent stools, yellowish-brown and foul-smelling stools, abdominal pain aggravated by pressure), secondary symptoms (fever, thirst, burning sensation in the anus, scanty dark urine, thirst with a desire to drink), and tongue and pulse characteristics (red tongue, yellow and greasy coating, slippery and rapid or floating and rapid pulse) were quantitatively scored. The primary symptom is scored as follows: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6 respectively. Secondary symptoms are scored as follows: none, mild, moderate, and severe, with scores of 0, 1, 2, and 3 respectively. Tongue and pulse examination are scored as follows: none and present, with scores of 0 and 1 respectively. Higher scores indicate more severe symptoms. ④ Drug safety. Observe and record any adverse reactions that occur during the patient's medication period.

[0057] 8. Efficacy evaluation criteria: formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" published in 2002 and the "Guidelines for the Diagnosis and Treatment of Ulcerative Colitis with Traditional Chinese Medicine (2023)".

[0058] Clinical remission: Clinical symptoms and signs basically disappeared, and the syndrome score decreased by ≥95%; Marked effect: Clinical symptoms and signs significantly improved, with 70% ≤ syndrome score decrease <95%; Effective: Clinical symptoms and signs improved, with 30% ≤ syndrome score decrease <70%; Ineffective: Clinical symptoms and signs showed no significant improvement, or even worsened, with the syndrome score decrease <30%. The efficacy index was calculated using the nimodipine method to assess the degree of symptom improvement. Efficacy index = (Symptom score before treatment - Syndrome score after treatment) / Syndrome score before treatment × 100%.

[0059] 9. Statistical methods: Data were analyzed using SPSS 26.0 statistical software.

[0060] For normally distributed continuous data, a two-sample t-test is used, expressed as x±s; for data that do not conform to a normal distribution, a two-sample rank-sum test is used, expressed as the median (upper and lower quartiles) [M(P25, P75)]. For categorical data, a two-sample t-test is used. Test. A p-value < 0.05 is considered statistically significant.

[0061] II. Results Statistics 1. Comparison of modified Mayo scores before and after treatment in the two groups: The modified Mayo scores of both groups decreased after treatment (P<0.01). Compared with the control group, the Mayo score of the observation group decreased (P<0.01). See Table 1 (Comparison of modified Mayo scores before and after treatment in the two groups).

[0062] Table 1 Note: *P<0.01 compared with pre-treatment levels; ##P<0.01 compared with the control group.

[0063] As shown in Table 1, the modified Mayo score of the observation group was lower than that of the control group after treatment, indicating that the addition of Dijinwu Baijian can more effectively alleviate UC activity.

[0064] 2. Comparison of TNF-α, ESR, and FC levels before and after treatment in both groups: After treatment, serum TNF-α and ESR levels in both groups decreased significantly compared to before treatment (P < 0.01), and FC levels decreased significantly compared to before treatment (P < 0.01). After treatment, TNF-α, ESR, and FC levels in the observation group were lower than those in the control group (P < 0.01, P < 0.05, P < 0.01). See Table 2 (Comparison of TNF-α, ESR, and FC levels between the two groups).

[0065] Table 2 Note: TNF-α, tumor necrosis factor-α; ESR, erythrocyte sedimentation rate; FC, fecal calprotectin.

[0066] Compared with pre-treatment levels, *P<0.01; compared with the control group, #P<0.05, #P<0.01.

[0067] As shown in Table 2, the fecal FC expression level of UC patients in the observation group was lower than that in the control group after treatment, and the serum TNF-α and ESR levels were also lower than those in the control group. This indicates that adding Dijinwu Baijian can more effectively alleviate intestinal inflammatory response and promote mucosal tissue healing.

[0068] 3. Comparison of TCM syndrome scores before and after treatment in the two groups: The TCM syndrome scores of both groups decreased after treatment (P<0.01). Compared with the control group, the TCM syndrome score of the observation group decreased (P<0.01). See Table 3 (Comparison of TCM syndrome scores before and after treatment in the two groups).

[0069] Table 3 Note: *P<0.01 compared with pre-treatment levels; ##P<0.01 compared with the control group.

[0070] 4. Comparison of TCM syndrome efficacy between the two groups: The TCM syndrome efficacy of the two groups was statistically significant after treatment (P<0.05). The total effective rate of TCM syndrome efficacy in the control group was 80.00%, while that in the observation group was 95.00%, with the observation group showing a higher effective rate than the control group. See Table 4 (Comparison of TCM syndrome efficacy between the two groups).

[0071] Table 4 4. Adverse reactions: No serious adverse reactions occurred in either group of patients during the treatment period.

[0072] As shown in Tables 3 and 4, the TCM syndrome score of UC patients in the observation group decreased significantly more than that in the control group, and the TCM syndrome efficacy in the observation group was better than that in the control group, indicating that adding Dijinwu Baijian can effectively improve the clinical symptoms of UC patients.

[0073] III. Discussion of Results Ulcers (UC) is a chronic inflammatory bowel disease characterized by inflammatory changes in the colonic mucosa, clinically manifesting as symptoms such as abdominal pain, rectal bleeding, and weight loss. Studies have shown that the occurrence of UC is closely related to genetics, environment, gut microbiota, and immune factors. UC is complex, protracted, and prone to relapse; therefore, integrated traditional Chinese and Western medicine treatments for UC often show superior efficacy in controlling symptoms and relapse compared to Western medicine alone.

[0074] In Traditional Chinese Medicine (TCM), ulcerative colitis (UC) falls under the categories of "dysentery," "chronic dysentery," "relapsing dysentery," and "intestinal dysentery," with the disease location in the intestines. Chen Yongcan believes that the pathogenesis of UC during its active phase is mostly due to internal damp-heat, stagnation of qi and blood, impaired transmission, obstruction of the large intestine, stagnation of qi, accumulation of heat and toxicity, damage to the membranes and collaterals, hence the bloody, purulent, and purulent diarrhea. Prolonged diarrhea easily damages the spleen, leading to spleen qi deficiency, qi deficiency and yang deficiency. With prolonged illness, the spleen becomes weak and the liver becomes overactive. At the same time, the chronic depletion of qi and blood gradually worsens. Qi deficiency leads to insufficient blood circulation, and blood deficiency leads to sluggish blood flow, resulting in blood stasis, heat, and scorching of body fluids and obstruction of collaterals, causing the disease to recur. Following the principle of "treating the symptoms in acute cases and addressing the root cause in chronic cases," and adhering to Ye Tianshi's idea that "entering the blood may cause blood loss and movement, so it is necessary to cool the blood and disperse blood stasis," Chen Yongcan organically combines methods of clearing heat and detoxifying with stopping bleeding and removing blood stasis, targeting the root cause of heat toxin damage and intestinal stagnation. By clearing heat and detoxifying and cooling the blood, the heat is cleared, preventing the blood from burning body fluids and causing blood stasis. By dispersing blood stasis, the heat toxin loses its attachment and does not bind with the stagnant blood, making it difficult to clear. Blood flows when warm, and when cooled, it can follow the meridians, ensuring smooth blood flow and stopping erratic bleeding. The combined use of these two methods achieves the effects of clearing heat and detoxifying, regulating the intestines, cooling the blood, removing blood stasis, and stopping bleeding.

[0075] The formula for *Euphorbia humifusa* decoction contains *Euphorbia humifusa*, which is bitter and pungent, and enters the liver and large intestine meridians. It excels at clearing heat and detoxifying, cooling the blood and stopping bleeding. The *Jia You Materia Medica* states that *Euphorbia humifusa* "mainly promotes blood circulation and can also be used to treat qi stagnation," indicating its blood-regulating and qi-regulating effects; therefore, it is the principal herb. Dandelion is bitter and cold in nature, and enters the liver and stomach meridians. It clears heat and detoxifies, assisting the principal herb in clearing heat and detoxifying, regulating the intestines and cooling the blood; therefore, it is the assistant herb. *Prunus mume* charcoal is added to astringe the intestines and stop bleeding; *Bletilla striata* astringes and stops bleeding, reduces swelling and promotes tissue regeneration; *Agrimonia pilosa* has astringent, hemostatic, anti-dysentery, and detoxifying effects; and *Lotus rhizome charcoal* astringes and stops bleeding, dissipates blood stasis, and stops bleeding without leaving blood stasis. The four herbs combined focus on stopping bleeding, cooling the blood, resolving blood stasis, and detoxifying. The entire formula, when used together, clears heat and detoxifies, regulates the intestines, resolves blood stasis, cools the blood, and stops bleeding.

[0076] Application Example 1 showed that the modified Mayo score of the observation group was lower than that of the control group after treatment, indicating that adding Dijin Wubai Decoction could more effectively relieve the activity of UC. The expression level of fecal FC in UC patients of the observation group after treatment was lower than that of the control group, and the serum TNF-α and ESR levels were also lower than those of the control group, indicating that adding Dijin Wubai Decoction could more effectively relieve intestinal inflammatory response and promote mucosal tissue healing.

[0077] In terms of TCM syndrome scores, the decline range of TCM syndrome scores in UC patients of the observation group was significantly greater than that of the control group, and the curative effect of TCM syndromes in the observation group was better than that of the control group, indicating that adding Dijin Wubai Decoction could effectively improve the clinical symptoms of UC patients.

[0078] IV. Explanation of Mechanism of Action The main active components such as kaempferol in Euphorbia humifusa regulate intestinal inflammatory response and promote intestinal mucosal repair by acting on core targets such as TNF and interleukin 6. The main active component taraxasterol in Taraxacum mongolicum can play a role in treating UC by improving the destruction of intestinal barrier in addition to reducing the release of pro-inflammatory factors. Melia toosendan carbon has a synergistic effect in hemostasis, inhibiting inflammatory response, resisting oxidative stress and repairing intestinal mucosal barrier. Agrimonia pilosa has the effects of reducing antioxidant and inhibiting inflammatory response, thereby improving mucosal barrier and playing a hemostatic role. Nelumbo nucifera carbon achieves the effect of hemostasis by regulating the whole process of coagulation-anticoagulation-thrombosis and mediating hemodynamic changes. These multi-target effects synergistically constitute the potential biological basis for Dijin Wubai Decoction to exert anti-inflammatory, hemostatic and mucosal repair effects.

[0079] In summary, oral administration of Dijin Wubai Decoction combined with mesalazine sustained-release tablets in the treatment of UC patients with heat-toxin stasis type has significant curative effect, effectively relieves the activity of UC, improves the clinical symptoms of patients, and inhibits inflammatory response, providing new possibilities for the future treatment of UC.

[0080] The above embodiments are only exemplary embodiments of the present application and are not used to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements within the essence and protection scope of the present application, and such modifications or equivalent replacements should also be regarded as falling within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating intestinal inflammation, characterized in that, The formulation of the traditional Chinese medicine composition, by weight, includes at least the following: 27-33 grams of Euphorbia humifusa, 27-33 grams of Taraxacum mongolicum, 8-10 grams of charred Prunus mume, 8-10 grams of Bletilla striata, 13-17 grams of Agrimonia pilosa, and 27-33 grams of charred Nelumbo nucifera rhizome.

2. The traditional Chinese medicine composition for treating intestinal inflammation according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, is as follows: 30g of Euphorbia humifusa, 30g of Taraxacum mongolicum, 9g of charred Prunus mume, 9g of Bletilla striata, 15g of Agrimonia pilosa, and 30g of charred Nelumbo nucifera rhizome.

3. The traditional Chinese medicine composition for treating intestinal inflammation according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, is as follows: 27g of Euphorbia humifusa, 27g of Taraxacum mongolicum, 8g of charred Prunus mume, 8g of Bletilla striata, 13g of Agrimonia pilosa, and 27g of charred Nelumbo nucifera rhizome.

4. The traditional Chinese medicine composition for treating intestinal inflammation according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, is as follows: 33g of Euphorbia humifusa, 33g of Taraxacum mongolicum, 10g of charred Prunus mume, 10g of Bletilla striata, 17g of Agrimonia pilosa, and 33g of charred Nelumbo nucifera rhizome.

5. The traditional Chinese medicine composition for treating intestinal inflammation according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, also includes one or more of the following: stir-fried Coptis chinensis, stir-fried Paeonia lactiflora, and Pulsatilla chinensis.

6. The traditional Chinese medicine composition for treating intestinal inflammation according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, also includes one or more of the following: stir-fried Saposhnikovia divaricata, dried tangerine peel, and stir-fried Atractylodes macrocephala.

7. A method for preparing a traditional Chinese medicine composition for treating intestinal inflammation as described in any one of claims 1-6, characterized in that, According to the formula of the Chinese herbal composition, mix all the Chinese herbal raw materials, add 400ml of water, bring to a boil over high heat, continue to decoct for 30 minutes, and filter to extract the medicinal liquid. Add 400ml of water to the dregs, bring to a boil over high heat, and continue to simmer for 30 minutes. Filter to extract the liquid. Combine the extracts from the two extractions.

8. The application of a traditional Chinese medicine composition for treating intestinal inflammation as described in any one of claims 1-6, characterized in that, The traditional Chinese medicine composition for treating intestinal inflammation is used to treat ulcerative colitis caused by heat toxin damage and intestinal stasis, and has the effects of clearing heat and detoxifying, regulating the intestines, removing blood stasis, cooling blood, and stopping bleeding.

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