A traditional Chinese medicine composition for treating ulcerative colitis

Abstract

This invention provides a traditional Chinese medicine composition for treating ulcerative colitis. The raw materials of the composition, by weight, include 10-15 parts of prepared Pinellia ternata, 3-10 parts of Coptis chinensis, 3-10 parts of Scutellaria baicalensis, 20-30 parts of palm charcoal, 10-30 parts of Poria cocos, 3-10 parts of dried ginger, 3-10 parts of cinnamon, 3-10 parts of vinegar-processed Cyperus rotundus, 3-10 parts of Aucklandia lappa, 10-30 parts of Epimedium brevicornu, 3-10 parts of ginseng slices, and 5-20 parts of stir-fried Atractylodes macrocephala. This traditional Chinese medicine composition is based on Banxia Xiexin Decoction, which aligns with the original text of the *Shanghan Lun* (Treatise on Cold Damage) regarding its ability to treat "borborygmus and diarrhea." It innovatively diagnoses common UC patients in clinical practice as having a pattern of alternating cold and heat, upper heat and lower cold, and deficiency of both spleen and kidney. Utilizing the principle of harmonizing cold and heat in Banxia Xiexin Decoction and adjusting the ingredients, significant therapeutic effects have been achieved, providing a new option for traditional Chinese medicine prescriptions in the treatment of ulcerative colitis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating ulcerative colitis. Background Technology

[0002] Ulcerative colitis (UC) is a common inflammatory disease of the digestive tract. Its main clinical manifestations include abdominal pain, diarrhea, tenesmus, and bloody, mucous stools. Complications include colon cancer, bleeding, obstruction, and toxic megacolon. It directly or indirectly affects people's quality of life and work efficiency, and is prone to recurrence, resulting in significant medical expenses. Western medicine treatments for UC often include salicylates, corticosteroids, immunosuppressants, probiotics, and surgery. While these methods can alleviate symptoms to some extent, they have drawbacks such as difficulty in treatment, long treatment cycles, high recurrence rates, high medical costs, and numerous adverse reactions.

[0003] Traditional Chinese medicine (TCM) has significant advantages in treating ulcerative colitis (UC). It views the disease holistically and emphasizes syndrome differentiation and treatment. Clinically, it effectively alleviates patient symptoms, improves patient constitution, has fewer adverse reactions, a lower recurrence rate, and is more affordable than Western medicine.

[0004] The "Expert Consensus on the Diagnosis and Treatment of Ulcerative Colitis Using Integrated Traditional Chinese and Western Medicine" classifies UC into eight syndrome types: damp-heat accumulation in the intestines, intense heat and toxicity, internal accumulation of turbid toxicity, spleen deficiency with dampness, mixed cold and heat syndrome, liver stagnation and spleen deficiency syndrome, blood stasis obstructing the intestinal collaterals syndrome, and spleen and kidney yang deficiency syndrome. Currently, most traditional Chinese medicine prescriptions for UC on the market target patients with damp-heat stagnation, treating them by clearing heat and promoting diuresis. A few traditional Chinese medicines are designed for patients in remission, focusing on strengthening the spleen and replenishing qi, and warming and tonifying the spleen and kidneys. For example, Chinese invention patent CN119896715A discloses a traditional Chinese medicine composition for treating ulcerative colitis, prepared from the following raw medicinal materials in parts by weight: ginseng 5-15 parts, cinnamon twig 8-25 parts, nutmeg 5-15 parts, poria cocos 8-25 parts, stir-fried atractylodes macrocephala 8-25 parts, dried ginger 5-15 parts, stir-fried coix seed 10-30 parts, indigo naturalis 1-5 parts, and coptis chinensis 2-6 parts. This composition has the functions of strengthening the spleen and replenishing qi, warming the kidneys and stopping diarrhea, and eliminating dampness and toxins, and is used to treat ulcerative colitis. However, this traditional Chinese medicine composition cannot exert its tonifying effect during the acute phase, so the efficacy is not lasting; and it does not exert its effect of clearing residual pathogens during the remission phase, so relapse is easy, and the efficacy is limited.

[0005] Banxia Xiexin Decoction is a commonly used formula in the classic Chinese medicine text *Shanghan Lun*. Currently, it is mostly used clinically to treat spleen and stomach disorders, characterized by epigastric fullness without pain, and nausea. However, given its poor efficacy in treating ulcerative colitis (UC), there are no records of large-scale clinical efficacy verification or promotion of its use in UC treatment guidelines. Summary of the Invention

[0006] In view of this, the present invention aims to propose a traditional Chinese medicine composition for treating ulcerative colitis, based on Banxia Xiexin Decoction, to form a therapeutic combination that can cover the common symptoms and syndromes of ulcerative colitis patients and achieve significant therapeutic effects.

[0007] To achieve the above objectives, the technical solution of the present invention is implemented as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating ulcerative colitis, wherein the raw materials of the traditional Chinese medicine composition include, by mass parts, 10-15 parts of processed Pinellia ternata, 3-10 parts of Coptis chinensis, 3-10 parts of Scutellaria baicalensis, 20-30 parts of palm charcoal, 10-30 parts of Poria cocos, 3-10 parts of dried ginger, 3-10 parts of cinnamon, 3-10 parts of vinegar-processed Cyperus rotundus, 3-10 parts of Aucklandia lappa, 10-30 parts of Epimedium brevicornu, 3-10 parts of ginseng slices, and 5-20 parts of stir-fried Atractylodes macrocephala.

[0008] The core pathogenesis of chronic ulcerative colitis is "a complex mixture of cold and heat, with deficiency of both spleen and kidney as the root cause, and dampness obstructing qi and causing hematochezia as the manifestation." The treatment strategy is to tonify both the spleen and kidney, balance cold and heat, regulate qi, dry dampness, and stop bleeding. This approach is suitable for ulcerative colitis patients with a long disease course and prominent symptoms of spleen and kidney deficiency, such as hematochezia, loose stools, persistent diarrhea, aversion to cold, cold limbs, irritability, and insomnia. The combination of traditional Chinese medicine herbs follows a close logical relationship, balancing the strengthening of the body's foundation with the elimination of pathogens, and warming yang with clearing heat. A detailed analysis follows: I. Principal Herb: Tonifying both the spleen and kidneys + clearing heat and eliminating pathogens, thus solidifying the core of treatment. The principal herbs form a four-dimensional core combination of "warming and tonifying the spleen and kidneys + clearing heat and drying dampness", which not only strengthens the "foundation" of chronic ulcerative colitis, but also precisely targets the symptoms of damp heat, thus resolving the core contradiction of the disease.

[0009] Epimedium is pungent, sweet, and warm in nature. It enters the liver and kidney meridians. It has the effects of tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness. It directly addresses the core pathogenesis of chronic ulcerative colitis, which involves "spleen disease affecting the kidneys." Prolonged diarrhea depletes kidney yang, and insufficient kidney yang leads to a lack of warmth in the spleen, further weakening its digestive function and creating a vicious cycle of "spleen and kidney deficiency - diarrhea - worsening yang deficiency." Epimedium warms and tonifies kidney yang, restoring the spleen and stomach's digestive function from the root by "tonifying the kidneys to warm the spleen," breaking the vicious cycle. At the same time, its warming properties can help the intestinal blood and qi circulation, improving mucosal circulatory disorders.

[0010] Ginseng is sweet, slightly bitter, and slightly warm in nature. It enters the spleen, lung, and heart meridians. It has the effects of greatly replenishing vital energy and strengthening the spleen and lungs. Together with epimedium, it forms the core framework of "dual tonification of the spleen and kidneys." Ginseng strongly tonifies the qi of the spleen and stomach, enhancing their digestive function. Epimedium, one tonifying the acquired foundation (spleen) and the other tonifying the innate foundation (kidney), works synergistically to strengthen the body's resistance and consolidate its foundation, enhancing the body's vital energy to resist pathogenic factors.

[0011] Stir-fried Atractylodes macrocephala is sweet, bitter, and warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. It assists ginseng in enhancing the spleen-strengthening and qi-replenishing effects, while drying dampness and promoting diuresis, directly transforming dampness and turbidity in the intestines, relieving symptoms such as loose stools and abdominal distension. It is a key drug connecting the spleen and kidneys and transforming dampness, allowing the "warming and tonifying" effect of the principal drug to better act on the intestines.

[0012] Coptis chinensis is bitter and cold in nature. It enters the heart, liver, stomach, and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It targets the symptoms of damp-heat in the intestines, and is especially suitable for symptoms during the active phase such as mucus and bloody stools, tenesmus, etc. It clears damp-heat in the large intestine, detoxifies and stops dysentery. It forms a "combination of warming and clearing" pattern with warming and tonifying principal herbs, avoiding the stagnation of damp-heat caused by simply warming and tonifying.

[0013] Scutellaria baicalensis is bitter and cold in nature. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, and stopping bleeding. When used in combination with Coptis chinensis, it enhances the heat-clearing and dampness-drying effects. Its hemostatic effect can directly improve bleeding caused by intestinal mucosal erosion, thus simultaneously eliminating pathogens and stopping bleeding as needed, balancing the drying properties of the warming herbs in the principal herb.

[0014] The system of five principal herbs achieves three major breakthroughs: "simultaneous supplementation of innate and acquired constitutions", "simultaneous support of the body's resistance and elimination of pathogenic factors", and "balance between warming yang and clearing heat". Compared with the original Banxia Xiexin Decoction, which uses Banxia as the principal herb, this invention adjusts ginseng, coptis, and scutellaria to be the principal herbs, and adds stir-fried atractylodes macrocephala and epimedium. It can more comprehensively and accurately adapt to the complex pathogenesis of chronic ulcerative colitis, which involves both deficiency and excess and cold and heat. It is especially suitable for patients with recurrent attacks, a weak and cold constitution, but still have damp-heat symptoms during the active phase.

[0015] II. Assistant Herbs: Assist the principal herb, enhance its core efficacy, and harmonize its medicinal properties. The assistant herbs revolve around the core function of the principal herb, namely "warming and tonifying the spleen and kidneys, clearing heat and drying dampness," or enhance the effects of removing dampness and warming the middle jiao, or alleviate gastrointestinal symptoms, thus avoiding bias in the efficacy of the principal herb and balancing efficacy and safety.

[0016] Pinellia ternata is pungent, warm, and toxic. It enters the spleen, stomach, and lung meridians. It has the effects of drying dampness and resolving phlegm, suppressing nausea and vomiting, and dissipating lumps and nodules. It assists Atractylodes macrocephala and ginseng in enhancing its dampness-drying power. Simultaneously, it addresses common symptoms in patients with ulcers, such as nausea and abdominal distension, by dissipating lumps and nodules, harmonizing the stomach, and suppressing nausea and vomiting, thus improving gastrointestinal qi stagnation and creating a favorable spleen and stomach environment for the warming and heat-clearing effects of the principal herb.

[0017] Dried ginger is pungent and hot. It enters the spleen, stomach, kidney, heart, and lung meridians. It has the effects of warming the middle jiao and dispelling cold, restoring yang and unblocking the meridians. On the one hand, it assists epimedium and ginseng in warming yang and dispelling cold, enhancing the warming power of the spleen and kidneys, and relieving symptoms such as aversion to cold and abdominal pain with a preference for warmth; on the other hand, it assists in restraining the bitter and cold nature of the chief herbs coptis and scutellaria, preventing cold herbs from damaging the already deficient spleen yang. It is a key assistant herb in harmonizing the cold and heat of the whole formula.

[0018] Poria cocos is sweet, bland, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. When used in conjunction with Atractylodes macrocephala, it enhances the spleen-strengthening and dampness-eliminating effects. Poria cocos is also more inclined to "dampness elimination," which can expel dampness and turbidity from the intestines through urination, clearing pathogenic factors from the lower burner, reducing the irritation of dampness on the intestines, and assisting the principal herb in relieving diarrhea symptoms.

[0019] III. Adjuvant Drugs: These drugs enhance efficacy, address concurrent symptoms, and protect against altered symptoms. Adjuvant medicines are divided into adjuvant drugs and adjuvant herbs. Adjuvant drugs directly assist the principal and assistant drugs in treating concurrent and variant symptoms. Adjuvant herbs restrain the overall imbalance of the prescription and protect the spleen and stomach. They not only provide precise treatment for concurrent symptoms such as hematochezia and qi stagnation, but also further restrain the imbalance of the drugs, while taking into account the variant symptoms that may occur during the course of the disease.

[0020] Palm charcoal is bitter and astringent, neutral in nature, and enters the liver, lung, and large intestine meridians. Its core function is to astringe and stop bleeding. For typical symptoms of ulcerative colitis, such as bloody stools with mucus and pus, it can astringe bleeding from damaged intestinal mucosa and quickly control bleeding symptoms, making it a core adjuvant medicine for symptomatic treatment.

[0021] Vinegar-processed Cyperus rotundus is pungent, slightly bitter, and slightly sweet, and neutral in nature. It enters the liver, spleen, and triple burner meridians. Its core functions are to soothe the liver and regulate qi, and to strengthen the spleen and stomach. Patients with ulcers often experience abdominal distension due to qi stagnation caused by emotional distress or dampness obstruction. Vinegar-processed Cyperus rotundus can soothe the liver and regulate qi, harmonize the qi mechanism of the spleen and stomach, relieve abdominal distension and pain, and improve the condition exacerbated by emotional fluctuations.

[0022] Costus root is pungent, bitter, and warm in nature, and enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. Its core functions are to regulate qi, relieve pain, strengthen the spleen, and promote digestion. When used in combination with vinegar-processed Cyperus rhizome, it enhances the qi-regulating effect. Costus root is also good at relieving qi stagnation in the large intestine, and is particularly effective for tenesmus symptoms. It also promotes digestion and improves patients' loss of appetite.

[0023] Cinnamon is pungent, sweet, and very hot in nature. It enters the kidney, spleen, heart, and liver meridians, and its core function is to tonify fire and assist yang, and warm and unblock the meridians. It assists the chief herb, epimedium, in enhancing the kidney yang tonification effect, while warming and unblocking the intestinal meridians, relieving abdominal pain caused by cold stagnation and blood stasis. Its warming properties can further enhance the overall therapeutic effect of "warming and tonifying the spleen and kidneys".

[0024] Cinnamon and dried ginger work together not only as adjuvants but also as important adjuvants. Through their warming properties, they further neutralize the bitter and cold nature of Coptis chinensis and Scutellaria baicalensis, preventing damage to the spleen and stomach function caused by long-term use of cold medicines. At the same time, they restrain the drying nature of warm medicines such as Epimedium and ginseng, preventing excessive warming and tonification from causing internal heat, thus achieving "warming without drying and clearing without harming yang".

[0025] IV. Guiding the medicine: Harmonizes the various medicines and guides them directly to the affected area via the meridians. This prescription continues the "adjuvant-instead-of-guide" formulation model, with some adjuvant herbs also serving as the harmonizing and guiding herbs, eliminating the need for additional guiding herbs, making it concise and highly effective. Costus root and vinegar-processed Cyperus rhizome regulate Qi and harmonize the middle Jiao. They can not only relieve symptoms of Qi stagnation, but also harmonize the properties of all the medicines in the formula, allowing the effects of various medicines such as warming, tonifying, clearing heat, and stopping bleeding to work synergistically and avoiding drug conflicts. Cinnamon's warming and meridian-clearing effects can guide the warming and tonifying power of the principal and assistant herbs, as well as the heat-clearing and pathogen-expelling power of the herbs, directly to the intestinal lesions, enhancing local efficacy and acting as a guiding herb.

[0026] V. Summary of Overall Compatibility Characteristics The prescription's core highlight is "dual tonification of the spleen and kidneys," retaining the original formula's balance of cold and heat in Banxia Xiexin Decoction and its spleen-strengthening and qi-tonifying structure in Sijunzi Decoction, while simultaneously enhancing its kidney-warming effect. This forms a complete treatment system of "tonifying the kidneys and warming the spleen to consolidate the foundation, clearing heat and drying dampness to eliminate pathogens, regulating qi and stopping bleeding to treat the symptoms, and harmonizing cold and heat to protect the body." This formula is precisely suited for chronic recurrent ulcerative colitis (spleen and kidney yang deficiency with internal damp-heat syndrome), and is especially suitable for patients with persistent diarrhea, aversion to cold and cold limbs, mucus and bloody stools, irritability, and insomnia. It embodies the wisdom of traditional Chinese medicine in "treating the root cause of the disease, treating both the symptoms and the root cause, and considering both cold and heat, deficiency and excess."

[0027] This invention innovatively proposes that, from the perspective of traditional Chinese medicine, UC (ulcerative colitis) is located in the intestines, but involves dysfunction of multiple organs such as the spleen, stomach, liver, and kidneys. Therefore, the treatment prescription takes into account the spleen, stomach, liver, and kidneys. The traditional Chinese medicine composition of this patent takes into account the influence of liver qi stagnation and adds costus root and cyperus rhizome to play the role of soothing the liver and regulating qi. The traditional Chinese medicine composition of this patent takes into account the effect of kidney yang deficiency on bowel movements, and adds cinnamon and epimedium; The traditional Chinese medicine composition in this patent takes into account that charcoal-based drugs can both stop bleeding and warm the yang, and palm charcoal is added; The traditional Chinese medicine composition of this patent takes into account that ginseng is less greasy and causes less abdominal distension than codonopsis, so ginseng slices are added.

[0028] Furthermore, the raw materials of the traditional Chinese medicine composition include, by mass parts, 12-14 parts of processed Pinellia ternata, 5-8 parts of Coptis chinensis, 5-8 parts of Scutellaria baicalensis, 23-28 parts of palm charcoal, 20-28 parts of Poria cocos, 5-8 parts of dried ginger, 5-8 parts of cinnamon, 5-8 parts of vinegar-processed Cyperus rotundus, 5-8 parts of Aucklandia lappa, 15-25 parts of Epimedium brevicornu, 5-8 parts of ginseng slices, and 10-18 parts of stir-fried Atractylodes macrocephala.

[0029] Furthermore, the raw materials of the traditional Chinese medicine composition include, by mass parts, 13 parts of Pinellia ternata, 7 parts of Coptis chinensis, 7 parts of Scutellaria baicalensis, 25 parts of palm charcoal, 25 parts of Poria cocos, 7 parts of dried ginger, 7 parts of cinnamon, 7 parts of vinegar-processed Cyperus rotundus, 7 parts of Aucklandia lappa, 18 parts of Epimedium brevicornu, 5 parts of ginseng slices, and 12 parts of stir-fried Atractylodes macrocephala.

[0030] Secondly, the present invention provides a method for preparing a traditional Chinese medicine composition for treating ulcerative colitis, the preparation method comprising the following steps: S1. Weigh the following Chinese medicinal materials according to the following proportions by weight: 10-15 parts of processed Pinellia ternata, 3-10 parts of Coptis chinensis, 3-10 parts of Scutellaria baicalensis, 20-30 parts of palm charcoal, 10-30 parts of Poria cocos, 3-10 parts of dried ginger, 3-10 parts of cinnamon, 3-10 parts of vinegar-processed Cyperus rotundus, 3-10 parts of Aucklandia lappa, 10-30 parts of Epimedium brevicornu, 3-10 parts of ginseng slices, and 5-20 parts of stir-fried Atractylodes macrocephala. S2. After soaking the Chinese herbal raw materials from step S1 in cold water, put them into a sealed pressure container for high-temperature and high-pressure decoction. The pressure range is 0.1Mpa-0.15Mpa, and the decoction time is 1-2 hours. The sealed pressure container has a built-in filter device, so there is no need for concentration or drying, and a Chinese herbal composition is obtained.

[0031] Furthermore, in step S2, the amount of cold water added is 8-15 times the mass of the Chinese herbal medicine raw materials, for example, 8, 9, 10, 11, 12, 13, 14, or 15 times; preferably 10 times. It is added all at once.

[0032] Furthermore, in step S2, the soaking temperature is 15-30℃, for example, it can be 15℃, 18℃, 20℃, 22℃, 25℃, 28℃, or 30℃, preferably 18-28℃, and the soaking time is 30-60min, for example, it can be 30min, 35min, 40min, 45min, 50min, 55min, or 60min, preferably 35-50min.

[0033] Thirdly, the present invention provides a traditional Chinese medicine preparation for treating ulcerative colitis, the traditional Chinese medicine preparation comprising the traditional Chinese medicine composition as described in the first aspect or the traditional Chinese medicine composition prepared by the preparation method as described in the second aspect.

[0034] Furthermore, the traditional Chinese medicine preparation also includes medically acceptable excipients to formulate different dosage forms.

[0035] Furthermore, the traditional Chinese medicine preparation is one of the following: decoction, pill, granule, capsule, tablet, powder, ointment, oral liquid, or powder.

[0036] Fourthly, the present invention provides the use of the traditional Chinese medicine composition as described in the first aspect or the preparation method as described in the second aspect in the preparation of a medicament for treating inflammatory diseases of the digestive tract; Preferably, the inflammatory disease of the digestive tract is ulcerative colitis.

[0037] Compared with existing technologies, the traditional Chinese medicine composition for treating ulcerative colitis described in this invention has the following advantages: The traditional Chinese medicine composition of this invention is based on Banxia Xiexin Decoction, which is used to treat spleen and stomach diseases. It innovatively uses it as a basic formula to treat ulcerative colitis (UC), which is consistent with the original text of "Treatise on Febrile Diseases" which states that it can treat "borborygmus and diarrhea". At the same time, it innovatively identifies the common UC patients in clinical practice as having a syndrome of cold and heat intermingling and upper heat and lower cold. It applies the idea of ​​Banxia Xiexin Decoction to balance cold and heat and adds or subtracts ingredients. Animal experiments have shown that it can effectively relieve the symptoms of IBD mice and has achieved significant therapeutic effects. It has good therapeutic potential and provides a new traditional Chinese medicine prescription option for the treatment of ulcerative colitis. Attached Figure Description

[0038] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings: Figure 1 The images show the total ion chromatograms of the traditional Chinese medicine composition using UPLC-Q-TOF-MS / MS, with the upper image showing the baseline peak in positive ion mode and the lower image showing the baseline peak in negative ion mode. Figure 2 A visualization of the "Traditional Chinese Medicine-Compound-Predicted Target" network of traditional Chinese medicine compositions; Figure 3 Venn diagram showing the intersection of potential targets of traditional Chinese medicine compositions and disease targets of ulcerative colitis; Figure 4 This is a protein-protein interaction (PPI) network diagram showing the intersection of the Chinese medicine composition and the target of ulcerative colitis. Drug represents the target of the Chinese medicine composition, and UC represents the target of ulcerative colitis. Figure 5 Bar chart showing the gene ontology (GO) functional enrichment analysis of the intersection targets of traditional Chinese medicine composition and ulcerative colitis; Figure 6 Bubble chart of Kyoto Genetics and Genome Encyclopedia (KEGG) pathway enrichment analysis for the intersection targets of traditional Chinese medicine composition and ulcerative colitis; Figure 7 This is a schematic diagram of the mouse's weight change curve; Figure 8 This is a schematic diagram of the scoring results for bloody stools in mice. Figure 9 A bar chart comparing the length of the colorectal region in mice; Figure 10 This is a schematic diagram comparing the length of the colon and rectum in mice. Detailed Implementation

[0039] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0040] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0041] Example 1

[0042] The preparation method of the traditional Chinese medicine composition for treating ulcerative colitis in this embodiment includes the following steps: S1. Weigh the following Chinese medicinal materials by weight: 13g of Pinellia ternata, 7g of Coptis chinensis, 7g of Scutellaria baicalensis, 25g of palm charcoal, 25g of Poria cocos, 7g of dried ginger, 7g of cinnamon, 7g of Cyperus rotundus (processed with vinegar), 7g of Aucklandia lappa, 18g of Epimedium brevicornu, 5g of ginseng slices, and 12g of stir-fried Atractylodes macrocephala. Dry the above Chinese medicinal materials at a constant temperature. All Chinese medicinal materials used in this example were purchased from Beijing Chunfeng Pharmaceutical Co., Ltd. S2. After soaking the Chinese herbal raw materials from step S1 in 10 times the amount of cold water at 18°C ​​for 50 minutes, put them into a sealed pressure container for high-temperature and high-pressure decoction. The decoction pressure is 0.15 MPa and the decoction time is 1.5 hours. Filter the decoction to obtain the Chinese herbal composition.

[0043] Example 2 The difference from Example 1 is that in step S1, the following Chinese herbal raw materials are weighed by weight: 12g of Pinellia ternata, 5g of Coptis chinensis, 5g of Scutellaria baicalensis, 23g of palm charcoal, 20g of Poria cocos, 5g of dried ginger, 5g of cinnamon, 5g of vinegar-processed Cyperus rotundus, 5g of Aucklandia lappa, 15g of Epimedium brevicornu, 6g of ginseng slices, and 10g of stir-fried Atractylodes macrocephala.

[0044] The other steps are the same as in Example 1.

[0045] Example 3 The difference from Example 1 is that in step S1, the following Chinese herbal raw materials are weighed by weight: 14g of Pinellia ternata, 8g of Coptis chinensis, 8g of Scutellaria baicalensis, 28g of palm charcoal, 28g of Poria cocos, 8g of dried ginger, 8g of cinnamon, 8g of Cyperus rotundus (processed with vinegar), 8g of Aucklandia lappa, 25g of Epimedium brevicornu, 8g of ginseng slices, and 18g of stir-fried Atractylodes macrocephala.

[0046] The other steps are the same as in Example 1.

[0047] Experimental Example 1: Identification of Chemical Composition Based on UPLC-Q-TOF-MS / MS The LC-MS / MS technology was used to perform full component scanning and identification of the traditional Chinese medicine composition, and a chemical composition database of the composition was established. (1) Instruments and conditions Instruments: Ultra-high performance liquid chromatograph (Waters, ACQUITY UPLC I-Class) and tandem quadrupole-time-of-flight mass spectrometer (Waters, Xevo G2-XS QTOF).

[0048] Chromatographic conditions: The column was an ACQUITY UPLC HSS T3 column (2.1×100mm, 1.8μm); the mobile phase was 0.1% formic acid water (A)-acetonitrile (B), with gradient elution (0-2min, 5%B; 2-20min, 5%-95%B; 20-22min, 95%B; 22-22.1min, 95%-5%B; 22.1-25min, 5%B); the flow rate was 0.4mL / min; the column temperature was 40℃; and the injection volume was 2μL.

[0049] Mass spectrometry conditions: Electrospray ionization (ESI) source, positive and negative ion modes for separate acquisition; capillary voltage ±2.5 kV; ion source temperature 120℃; desolvation gas temperature 450℃; cone gas flow rate 50 L / h, desolvation gas flow rate 800 L / h; scan range m / z 50-1200; data acquisition using MSE mode (low collision energy 6 eV, high collision energy 20-40 eV ramp).

[0050] (2) Sample processing and data analysis An appropriate amount of the traditional Chinese medicine composition prepared in Example 1 was filtered through a 0.22 μm microporous membrane and then analyzed. The results are as follows. Figure 1 As shown. Raw data were processed using Progenesis QI software. Compound identification was performed by comparing the data with built-in databases (such as TCM and ChemSpider) and a self-built database, based on precise molecular weight (error <5 ppm), secondary fragment ion information, and retention time. Ultimately, a total of 151 major chemical components, including alkaloids, flavonoids, terpenes, and organic acids, were identified from this traditional Chinese medicine composition, clarifying its material profile.

[0051] Experimental Example 2: Mechanism Prediction Based on Network Pharmacology Based on the chemical components identified in Example 1, network pharmacology was used to screen potential active ingredients, predict their targets, and match them with UC disease targets to construct a multidimensional interaction network of "drug-component-target-pathway" to predict their mechanism of action at the system level. (1) Screening of active ingredients and prediction of targets Potential active ingredients were screened using the TCMSP database based on oral bioavailability (OB≥30%) and drug-likeness (DL≥0.18). Using the SwissTargetPrediction platform, potential human target proteins were predicted based on the 2D / 3D structural similarity principle of the ingredients. After collection and deduplication, a potential target set of the traditional Chinese medicine composition (T1, 791 in total) was obtained.

[0052] (2) Disease target acquisition and core target screening Using "Ulcerative Colitis" as the keyword, UC-related targets were searched in the GeneCards, OMIM, DisGeNET, and DrugBank databases. After merging and deduplicating, a disease target set (T2, 5992 targets) was obtained. The intersection of T1 and T2 yielded a potential core target set (T, 469 targets) for traditional Chinese medicine compositions to treat UC. A Venn diagram was drawn using the Venny 2.1 online tool (e.g., ...). Figure 3 (As shown).

[0053] (3) Network construction and topology analysis The relationships between active ingredients and overlapping targets were imported into Cytoscape 3.9.1 software to construct a "drug-ingredient-target" network (e.g., ...). Figure 2 (As shown). Using the Network Analyzer tool for topological analysis, with "Degree" and "Betweenness Centrality" as key indicators, 10 key active ingredients were screened, including hexahydrocurcumin, baicalin, hesperidin, 10-gingerol, baicalein II, palmatine, epiberberine, wogonin, and 8-gingerol, as well as 15 core targets, including TP53, STAT3, SRC, ESR1, JUN, AKT1, HSP90AA1, EP300, RELA, MAPK1, EGFR, NFKB1, HSP90AB1, MAPK3, and TNF.

[0054] (4) PPI network construction and enrichment analysis 469 intersecting target sites were imported into the STRING 11.5 database. A minimum interaction confidence level of 0.700 was set to construct a protein-protein interaction network. The results were exported to Cytoscape for visualization (e.g., ...). Figure 4 As shown). The DAVID 6.8 database was used to perform GO function and KEGG pathway enrichment analysis on the intersection targets, with P < 0.05 defined as significant. GO analysis showed that the targets were mainly enriched in biological processes such as white matter phosphorylation, insulin-like growth factor receptor signaling pathway, epidermal growth factor receptor signaling pathway, Ephrin receptor signaling pathway, and response to foreign stimuli (e.g., Figure 5 (As shown). KEGG analysis showed that the target was significantly enriched in cancer pathways, lipid and atherosclerosis, hepatitis B, Kaposi's sarcoma-associated herpesvirus infection, MAPK signaling pathway, etc. (e.g.) Figure 6 (As shown).

[0055] Experiment Example 3: Verification of Molecular Docking For the key active ingredients and core targets predicted by the network, molecular docking technology is used to simulate their combination, verifying the possibility of their interaction at the molecular level, thereby empirically validating and refining the prediction network. (1) Docking preparation From the core targets screened in Experiment Example 2, TP53, STAT3, SRC, ESR1, JUN, AKT1, HSP90AA1, EP300, RELA, MAPK1, EGFR, NFKB1, HSP90AB1, MAPK3, and TNF were selected as receptor proteins. The 3D structures of the key active ingredients hexahydrocurcumin, baicalin, hesperidin, 10-gingerol, and purslane were downloaded from the PubChem database as ligands. AutoDockTools 1.5.6 software was used to process the receptors and ligands: removing water molecules from the protein crystal structures, adding hydrogen, and distributing charges; the ligands were converted to pdbqt format.

[0056] (2) Analysis of docking process and results Semi-flexible docking was performed using AutoDock Vina 1.1.2. The docking grid was centered in the protoligand binding pocket or the protein active site, and the grid size was set to 40×40×40 Å. Docking results were evaluated using binding free energy (ΔG, kcal / mol), with a lower ΔG value indicating more stable binding. Generally, ΔG < -5.0 kcal / mol was considered to indicate good binding activity. The results are shown in Table 1. The binding energy of most active ingredients and core targets was ≤ -5.0 kcal / mol, indicating that the traditional Chinese medicine composition of this invention has strong binding to UC and is key to the treatment of UC.

[0057] Table 1. Binding energy between active ingredients and core targets

[0058] Experiment Example 4: Animal Experiment Six- to eight-week-old male C57BL / 6 mice were selected and, after one week of acclimatization, were randomly divided into five herbal medicine groups and one control group. The mice were then given 2.5% DSS solution orally for seven consecutive days. During this period, the five herbal medicine groups received the herbal composition prepared in Example 1 via gavage once daily at a concentration of 2 g / mL, 150 μL per mouse per dose. The control group received normal drinking water via gavage once daily. Body weight was measured daily, and fecal characteristics and bleeding were recorded, with a bloody stool score assigned. On day 8, the mice were sacrificed, and the length of the colon and rectum was measured and photographed. Data were recorded and statistically analyzed.

[0059] The methods for evaluating drug efficacy are as follows: (1) Weight change: Weigh yourself daily and plot a weight change curve; (2) Bloody stool score: The scoring criteria are shown in Table 2: Table 2 Scoring Criteria

[0060] (3) Colorectal length: Mice were sacrificed at the end of the experiment and the length of the colorectal length from the cecum to the anus was measured to reflect the degree of intestinal inflammation and fibrosis.

[0061] according to Figure 7 The results showed that the control group mice experienced a significant decrease in body weight, while the mice in the traditional Chinese medicine group experienced a slower decrease in body weight compared to the control group, and retained an average of more than 10% more body weight, proving that the traditional Chinese medicine composition in Example 1 can effectively slow down the rate of body weight loss in mice; according to Figure 8 The results showed that the bloody stool score was increased in the control group mice, while the bloody stool score in the traditional Chinese medicine group mice was reduced by more than 1.5 points compared to the control group, proving that the traditional Chinese medicine composition in Example 1 can effectively improve bloody stool and has a relieving effect on the inflammation of ulcerative colitis (UC); according to Figure 9-10 The results showed that the colon and rectum of mice in the control group were shortened, while the colon and rectum of mice in the traditional Chinese medicine group recovered significantly, with the colon and rectum length increasing by more than 1.5 cm compared with the control group (P<0.05). This demonstrates that the traditional Chinese medicine composition in Example 1 can effectively alleviate intestinal inflammation and fibrosis. All of the above results were statistically significant.

[0062] This invention innovatively uses Banxia Xiexin Decoction, a traditional Chinese medicine formula for treating spleen and stomach disorders, as a basic prescription for treating ulcerative colitis (UC). The therapeutic effect on UC is improved by adjusting the composition of the herbs. Simultaneously, this invention proposes an integrated research strategy for the modified traditional Chinese medicine composition: "LC-MS / MS chemical component identification → network pharmacology mechanism prediction → molecular docking key verification," achieving a complete chain of explanation from chemical substances to biological mechanisms. It not only confirms the potential targets and pathways of the traditional Chinese medicine composition (such as STAT3, AKT1, and PI3K-Akt pathways), but also confirms the binding potential of key chemical components to targets through molecular docking, making the mechanism research more convincing and in-depth. Animal experiments have demonstrated its ability to effectively alleviate IBD symptoms in mice, achieving significant therapeutic effects and showing good therapeutic potential for UC, providing a new traditional Chinese medicine prescription option for the treatment of ulcerative colitis. Furthermore, the clearly defined chemical composition spectrum of this invention provides a direct basis for subsequent quality control, standard setting, and screening of effective components.

[0063] The embodiments described above are only some embodiments of the present invention, not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are all within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating ulcerative colitis, characterized in that: The raw materials of the Chinese herbal composition, by mass parts, include 10-15 parts of processed Pinellia ternata, 3-10 parts of Coptis chinensis, 3-10 parts of Scutellaria baicalensis, 20-30 parts of palm charcoal, 10-30 parts of Poria cocos, 3-10 parts of dried ginger, 3-10 parts of cinnamon, 3-10 parts of vinegar-processed Cyperus rotundus, 3-10 parts of Aucklandia lappa, 10-30 parts of Epimedium brevicornu, 3-10 parts of ginseng slices, and 5-20 parts of stir-fried Atractylodes macrocephala.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The raw materials of the Chinese herbal composition, by mass parts, include 12-14 parts of processed Pinellia ternata, 5-8 parts of Coptis chinensis, 5-8 parts of Scutellaria baicalensis, 23-28 parts of palm charcoal, 20-28 parts of Poria cocos, 5-8 parts of dried ginger, 5-8 parts of cinnamon, 5-8 parts of vinegar-processed Cyperus rotundus, 5-8 parts of Aucklandia lappa, 15-25 parts of Epimedium brevicornu, 5-8 parts of ginseng slices, and 10-18 parts of stir-fried Atractylodes macrocephala.

3. The traditional Chinese medicine composition according to claim 1, characterized in that: The raw materials of the Chinese herbal composition, by mass parts, include 13 parts of Pinellia ternata, 7 parts of Coptis chinensis, 7 parts of Scutellaria baicalensis, 25 parts of palm charcoal, 25 parts of Poria cocos, 7 parts of dried ginger, 7 parts of cinnamon, 7 parts of vinegar-processed Cyperus rotundus, 7 parts of Aucklandia lappa, 18 parts of Epimedium brevicornu, 5 parts of ginseng slices, and 12 parts of stir-fried Atractylodes macrocephala.

4. A method for preparing a traditional Chinese medicine composition for treating ulcerative colitis as described in any one of claims 1-3, characterized in that, The preparation method includes the following steps: S1. Weigh the raw materials according to the mass fractions; S2. After soaking the Chinese herbal raw materials from step S1 in cold water, put them into a sealed pressure container and decoct them under high temperature and high pressure to obtain a Chinese herbal composition.

5. The preparation method according to claim 4, characterized in that: In step S2, the amount of cold water added is 8-15 times the mass of the Chinese herbal raw materials.

6. The preparation method according to claim 4, characterized in that: In step S2, the soaking temperature is 15-30℃ and the soaking time is 30-60 min; preferably, the high-temperature and high-pressure cooking pressure is 0.1-0.15 MPa and the time is 1-2 h.

7. A traditional Chinese medicine preparation for treating ulcerative colitis, characterized in that: The traditional Chinese medicine preparation includes the traditional Chinese medicine composition as described in any one of claims 1-3 or the traditional Chinese medicine composition prepared by the preparation method as described in any one of claims 4-6.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that: The traditional Chinese medicine preparations also include medically acceptable excipients.

9. The traditional Chinese medicine preparation according to claim 7, characterized in that: The traditional Chinese medicine preparation is one of the following: decoction, pill, granule, capsule, tablet, powder, ointment, oral liquid, or powder.

10. The use of the traditional Chinese medicine composition as described in any one of claims 1-3 or the preparation method as described in any one of claims 4-6 in the preparation of a medicament for treating inflammatory diseases of the digestive tract; preferably, the inflammatory disease of the digestive tract is ulcerative colitis.

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