Traditional Chinese medicine prescription for treating radiation enteritis as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine prescription for treating radiation enteritis and a preparation method and application thereof. The traditional Chinese medicine prescription is prepared from, by mass, 10-15 g of radix puerariae, 9-12 g of rhizoma coptidis, 6-15 g of radix scutellariae, 6-10 g of radix aucklandiae, 5-10 g of herba pogostemonis, 8-12 g of herba eupatorii, 20-25 g of herba taraxaci, 15-20 g of herba agrimoniae, 15-25 g of caulis sargentodoxae, 5-15 g of radix sanguisorbae, 6-10 g of flos sophorae, 5-10 g of charred pollen typhae and 10-20 g of rhizoma alismatis. The invention solves the problem of lack of long-term effective treatment means for radiation enteritis with small side effect in the prior art, and provides a traditional Chinese medicine alternative scheme for radiation enteritis, which is safe and effective, can be used for local targeted treatment and has the advantages of simple preparation and low cost.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and in particular relates to a traditional Chinese medicine formula for treating radiation enteritis, its preparation method and application. Background Technology

[0002] Radiation enteritis is caused by radiation damage to the intestines during radiotherapy for malignant tumors in the pelvic cavity, abdominal cavity, and retroperitoneum. With increasing radiation dose, radiation directly damages intestinal mucosal cells, leading to increased vasculitis and submucosal fibrosis, thickening of the intestinal wall, and eventually ulceration and necrosis. In severe cases, it can cause intestinal perforation. Recovery from radiation enteritis is slow and prone to recurrence. If left untreated, it can lead to chronic diarrhea, malnutrition, and even a deterioration of the patient's overall health, severely impacting their quality of life.

[0003] Currently, Western medicine treatments for radiation enteritis typically rely on large amounts of antibiotics and hormones. However, these treatments have limited effectiveness, and long-term use can easily lead to side effects such as drug resistance and dysbiosis. In contrast, traditional Chinese medicine enemas have the advantages of being highly targeted and having significant local effects. They can act directly on the intestines, effectively relieving inflammation and discomfort caused by radiation enteritis. Through the synergistic effect of multiple components, traditional Chinese medicine enemas can promote intestinal repair, improve mucosal damage, and reduce systemic side effects, making them suitable for long-term use by patients with chronic diseases.

[0004] However, while existing traditional Chinese medicine enemas have advantages in local treatment, most formulations lack standardized processes and clear evidence of dose-response relationships. Therefore, to address the current challenges in treatment, this invention aims to explore a traditional Chinese medicine enema for treating radiation enteritis. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine formula for treating radiation enteritis, its preparation method, and its application, thereby solving the problem of the lack of long-term effective treatment methods for radiation enteritis with few side effects in the existing technology. This invention provides a safe, effective, locally targeted treatment alternative for radiation enteritis, which also has the advantages of simple preparation and low cost.

[0006] The technical solution adopted in this invention is a traditional Chinese medicine formula for treating radiation enteritis, comprising the following raw materials in the indicated mass proportions: Kudzu root 10-15g, Coptis chinensis 9-12g, Scutellaria baicalensis 6-15g, Aucklandia lappa 6-10g, Pogostemon cablin 5-10g, Eupatorium fortunei 8-12g, Taraxacum mongolicum 20-25g, Agrimonia pilosa 15-20g, Sargentodoxa cuneata 15-25g, Sanguisorba officinalis 5-15g, Sophora japonica 6-10g, Typha orientalis pollen charcoal 5-10g, Alisma plantago-aquatica 10-20g.

[0007] Furthermore, it comprises the following active pharmaceutical ingredient in the indicated mass proportions: Kudzu root 10g, Coptis chinensis 10g, Scutellaria baicalensis 6g, Aucklandia lappa 8g, Pogostemon cablin 5g, Eupatorium fortunei 10g, Taraxacum mongolicum 20g, Agrimonia pilosa 20g, Sargentodoxa cuneata 20g, Sanguisorba officinalis 5g, Sophora japonica 6g, Typha orientalis pollen charcoal 5g, Alisma plantago-aquatica 10g.

[0008] Furthermore, the preparation method of the traditional Chinese medicine formula includes the following steps: (1) Weigh the raw materials of the Chinese herbal medicine formula according to the mass ratio, soak them in water and then decoct them, and combine the decoctions; (2) The decoction is filtered and then centrifuged; (3) The centrifuged drug solution is concentrated under reduced pressure to a clear extract with a relative density of 1.03 to 1.12 at 60°C; (4) Add preservatives to the ointment, add water to make up the volume, stir evenly, filter and fill to obtain the finished product.

[0009] Further, in step (1), the herbs are soaked in water for 30-60 minutes and decocted 2-3 times under normal pressure and 100℃ conditions; wherein, the amount of water added for the first decoction is 6-10 times the total mass of the herbs, and the decoction is carried out for 1.5-2.0 hours; the amount of water added for the second decoction is 6-8 times the total mass of the herbs, and the decoction is carried out for 1.0-1.5 hours; and the amount of water added for the third decoction is 5-7 times the total mass of the herbs, and the decoction is carried out for 1.0-1.5 hours.

[0010] Furthermore, in step (2), the decoction is filtered through a 100-200 mesh filter, and the resulting filtrate is centrifuged online at a speed of 15000-25000 r / min.

[0011] Furthermore, step (3) is carried out under conditions of vacuum of -0.05 MPa to -0.10 MPa and temperature of 60°C to 70°C.

[0012] Furthermore, in step (4), the preservative is sodium benzoate, and the amount of sodium benzoate added is 2g per 1000mL of finished product.

[0013] The present invention also provides the application of the above-mentioned traditional Chinese medicine formula in the preparation of a drug for treating radiation enteritis.

[0014] The beneficial effects of this invention are as follows: Addressing the current lack of standardized treatment protocols, inconsistent efficacy evaluation systems, and specific drugs for radiation enteritis in clinical practice, this invention provides a definite and effective traditional Chinese medicine enema treatment plan. The traditional Chinese medicine formula used in this plan consists of multiple herbs including kudzu root, coptis root, scutellaria root, costus root, patchouli, eupatorium, dandelion, agrimony, sarsaparilla root, burnet root, sophora flower, charred cattail pollen, and alisma rhizome, which can effectively improve intestinal barrier damage caused by radiotherapy. Through rectal drip administration, the drug can directly act on the lesion site, increasing local blood drug concentration and significantly enhancing clinical efficacy, while avoiding the first-pass effect of oral medication and reducing the burden on the patient's liver and kidneys. Furthermore, the formula described in this invention has the comprehensive advantages of simple preparation, low cost, good stability, high safety, and significant efficacy. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a graph showing the results of the enema solution of the present invention on the general condition score of model rats.

[0017] Figure 2 This is a graph showing the results of the enema solution of the present invention on the pathological damage score of rat rectal tissue.

[0018] Figure 3 The diagram shows a comparison of the regulatory effects of the enema solution of this invention on serum inflammatory factors in model rats. In the diagram, A represents IL-6, B represents IL-8, C represents IL-10, and D represents TNF-α. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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.

[0020] The pharmacodynamic and toxicity tests of this invention were mainly conducted on the preparation of the medicine prepared in Example 4. The different component ratios provided in Examples 1 to 3, and the alternative process parameters disclosed in Examples 5 and 6, are all specific implementations guided by the core formulation principles of this invention (i.e., clearing heat and detoxifying, cooling blood and stopping bleeding, resolving dampness and stopping diarrhea). These examples, by adjusting the dosage ratios of each medicinal material or the extraction and concentration process conditions, aim to adapt to the differences in constitution and severity of illness among different patients. Their efficacy is based on the shared principles of principal, assistant, adjuvant, and guide formulation and the main active ingredients. Therefore, given that the effectiveness and safety of Example 4 have been verified, those skilled in the art can reasonably expect that other examples based on the same treatment principles can also achieve the beneficial effects of this invention. The invention will be further described in detail below through specific examples.

[0021] Example 1: A traditional Chinese medicine formula for treating radiation enteritis comprises the following components by weight: Kudzu root 10g, Coptis chinensis 10g, Scutellaria baicalensis 6g, Aucklandia lappa 8g, Pogostemon cablin 5g, Eupatorium fortunei 10g, Taraxacum mongolicum 20g, Agrimonia pilosa 20g, Sargentodoxa cuneata 20g, Sanguisorba officinalis 5g, Sophora japonica 6g, Typha orientalis pollen charcoal 5g, Alisma plantago-aquatica 10g.

[0022] Example 2: A traditional Chinese medicine formula for treating radiation enteritis comprises the following components by weight: Kudzu root 12g, Coptis chinensis 12g, Scutellaria baicalensis 9g, Aucklandia lappa 10g, Pogostemon cablin 6g, Eupatorium fortunei 12g, Taraxacum mongolicum 20g, Agrimonia pilosa 20g, Sargentodoxa cuneata 25g, Sanguisorba officinalis 10g, Sophora japonica 10g, Typha orientalis pollen charcoal 6g, Alisma plantago-aquatica 15g.

[0023] Example 3: A traditional Chinese medicine formula for treating radiation enteritis comprises the following components by weight: Kudzu root 15g, Coptis chinensis 9g, Scutellaria baicalensis 15g, Aucklandia lappa 6g, Pogostemon cablin 10g, Eupatorium fortunei 8g, Taraxacum mongolicum 25g, Agrimonia pilosa 15g, Sargentodoxa cuneata 15g, Sanguisorba officinalis 15g, Sophora japonica 10g, Typha orientalis pollen charcoal 10g, Alisma plantago-aquatica 20g.

[0024] Example 4: A method for preparing a traditional Chinese medicine formula for treating radiation enteritis includes the following steps: According to the formulation of the traditional Chinese medicine prescription in Example 1, the names and specifications of the medicinal slices are as follows: 10g of kudzu root, 10g of coptis root, 6g of scutellaria root, 8g of costus root, 5g of patchouli, 10g of eupatorium, 20g of dandelion, 20g of agrimony, 20g of sarsaparilla, 5g of burnet root, 6g of sophora flower, 5g of charred cattail pollen, and 10g of alisma rhizome. All medicinal slices are qualified processed medicinal slices that meet the quality standards of the 2025 edition of the Pharmacopoeia of the People's Republic of China, and no pulverization or other pretreatment is performed before feeding.

[0025] In preparation, firstly, add water equivalent to 8 times the total mass of the medicinal materials and soak for 45 minutes; then heat to 100℃ under normal pressure and decoct three times; the first decoction lasts for 2.0 hours, the second decoction adds 7 times the mass of the medicinal materials and decocts for 1.5 hours; the third decoction adds 6 times the total mass of the medicinal materials and decocts for 1.5 hours, and combines all the decoctions; the decoction is filtered through a 150-mesh filter and then centrifuged online at 20,000 r / min using a tubular centrifuge; the centrifuged liquid is placed in a vacuum concentration device and concentrated under vacuum of -0.08 MPa and working temperature of 65℃ to a clear extract with a relative density of 1.10 at 60℃; after cooling the clear extract, add 2g of sodium benzoate as a preservative, stir until completely dissolved, then add drinking water to make up to a total volume of 1000mL, stir thoroughly, filter again, and finally fill into the final product.

[0026] Example 5: A method for preparing a traditional Chinese medicine formula for treating radiation enteritis includes the following steps: According to the formulation of the traditional Chinese medicine prescription in Example 1, the names and specifications of the medicinal slices are as follows: 10g of kudzu root, 10g of coptis root, 6g of scutellaria root, 8g of costus root, 5g of patchouli, 10g of eupatorium, 20g of dandelion, 20g of agrimony, 20g of sarsaparilla, 5g of burnet root, 6g of sophora flower, 5g of charred cattail pollen, and 10g of alisma rhizome. All medicinal slices are qualified processed medicinal slices that meet the quality standards of the 2025 edition of the Pharmacopoeia of the People's Republic of China, and no pulverization or other pretreatment is performed before feeding.

[0027] In preparation, firstly, add water equivalent to 6 times the total mass of the medicinal materials and soak for 30 minutes; then heat to 100℃ under normal pressure and decoct three times; the first decoction lasts for 1.5 hours, the second decoction adds water equivalent to 6 times the mass of the medicinal materials and decocts for 1.0 hour; the third decoction adds water equivalent to 5 times the total mass of the medicinal materials and decocts for 1.0 hour, and combines all the decoctions; the decoction is filtered through a 100-mesh filter and then centrifuged online at 15000 r / min using a tubular centrifuge; the centrifuged decoction is placed in a vacuum concentration device and concentrated under vacuum of -0.05 MPa and working temperature of 60℃ to a clear extract with a relative density of 1.12 at 60℃; after cooling the clear extract, add 2g of sodium benzoate as a preservative, stir until completely dissolved, then add drinking water to make up to a total volume of 1000mL, stir thoroughly, filter again, and finally fill into the final product.

[0028] Example 6: A method for preparing a traditional Chinese medicine formula for treating radiation enteritis includes the following steps: According to the formulation of the traditional Chinese medicine prescription in Example 1, the names and specifications of the medicinal slices are as follows: 10g of kudzu root, 10g of coptis root, 6g of scutellaria root, 8g of costus root, 5g of patchouli, 10g of eupatorium, 20g of dandelion, 20g of agrimony, 20g of sarsaparilla, 5g of burnet root, 6g of sophora flower, 5g of charred cattail pollen, and 10g of alisma rhizome. All medicinal slices are qualified processed medicinal slices that meet the quality standards of the 2025 edition of the Pharmacopoeia of the People's Republic of China, and no pulverization or other pretreatment is performed before feeding.

[0029] In preparation, firstly, add water equivalent to 10 times the total mass of the medicinal materials and soak for 60 minutes; then heat to 100℃ under normal pressure and decoct three times; the first decoction lasts for 2.0 hours, the second decoction adds water equivalent to 8 times the mass of the medicinal materials and decocts for 1.5 hours; the third decoction adds water equivalent to 7 times the total mass of the medicinal materials and decocts for 1.5 hours, and combines all the decoctions; the decoction is filtered through a 200-mesh filter and then centrifuged online at 25000 r / min using a tubular centrifuge; the centrifuged decoction is placed in a vacuum concentration device and concentrated under vacuum of -0.10 MPa and working temperature of 70℃ to a clear extract with a relative density of 1.03 at 60℃; after cooling the obtained clear extract, add 2g of sodium benzoate as a preservative, stir until completely dissolved, then add drinking water to make up to a total volume of 1000mL, stir thoroughly, filter again, and finally fill into the final product.

[0030] The specific administration method of the traditional Chinese medicine formula of the present invention is as follows: rectal drip, allowing the medicine to directly contact the lesion site through retention enema, with a dose of 125ml each time, twice a day; the dosage can be flexibly adjusted according to the patient's condition.

[0031] The medicinal properties and efficacy of each raw material in the traditional Chinese medicine formula of this invention are described below: Kudzu root: the dried root of the legume *Pueraria lobata*; sweet and warm in nature, it enters the liver and kidney meridians; it has the functions of removing blood stasis, generating new blood, and promoting blood circulation; it is mainly used to treat numbness in the hands and feet, anemia, and irregular menstruation; the *Shennong Bencao Jing* records that it treats thirst, high fever, vomiting, various types of numbness, invigorates yin energy, and detoxifies. In the treatment of radiation enteritis, kudzu root can firstly raise the clear yang of the spleen and stomach to stop diarrhea; secondly, it can relieve muscle tension and reduce fever to disperse the "fire toxins" in the intestines and muscles.

[0032] Coptis chinensis: the dried rhizome of the plant Coptis chinensis (Ranunculaceae family); bitter and cold in nature, it enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians; it has the functions of clearing heat and drying dampness, purging fire and detoxifying; it is mainly used to treat damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and delirium, excessive heart fire, restlessness and insomnia, palpitations, hematemesis and epistaxis due to blood heat, red eyes, toothache, diabetes, carbuncles and sores. In the treatment of radiation enteritis, Coptis chinensis can clear and purge the excess fire in the intestines to directly counteract the heat toxicity; secondly, it can purge fire, cool the blood, and detoxify to calm the collaterals and stop bleeding.

[0033] Scutellaria baicalensis: the dried root of Scutellaria baicalensis, a plant in the Lamiaceae family; bitter and cold in nature, it enters the lung, gallbladder, spleen, large intestine, and small intestine meridians; it has the functions of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus; it is mainly used to treat damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, hematemesis and epistaxis due to blood heat, carbuncles and boils, and threatened abortion. In the treatment of radiation enteritis, the effects of Scutellaria baicalensis are similar to those of Coptis chinensis: firstly, it can dry dampness and clear heat, thicken the intestines and stop diarrhea, thus removing damp-heat from the intestines; secondly, it can purge fire and cool the blood, detoxify and calm the collaterals, thus calming the bleeding and stopping abnormal bleeding.

[0034] Costus root: The dried root of Costus root (Aucklandia lappa), a plant in the Asteraceae family; pungent and warm in nature, bitter in taste. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians; it has the functions of regulating qi and relieving pain, strengthening the spleen and promoting digestion; it is mainly used to treat chest and rib pain, abdominal distension and pain, tenesmus after diarrhea, indigestion, loss of appetite, and diarrhea with abdominal pain. In the treatment of radiation enteritis, Costus root can: 1) regulate qi and relieve stagnation, break up blockages and eliminate lumps, thus clearing obstructed qi in the internal organs; 2) regulate qi and relieve chest congestion, invigorate the spleen and aid digestion, thus restoring the function of the middle burner; 3) regulate qi and relieve pain, harmonize blood and stop diarrhea, thus eliminating tenesmus and bloody stools.

[0035] Patchouli: The dried aerial parts of the patchouli plant (Lamiaceae family); pungent and warm in nature. It enters the spleen, stomach, and lung meridians; it functions to resolve dampness and invigorate the spleen, dispel foulness and harmonize the middle jiao, relieve summer heat, and release exterior pathogens; it is mainly used to treat dampness obstructing the spleen and stomach, abdominal distension, early stage of damp-heat syndrome, vomiting, diarrhea, summer-heat dampness, fever and chills, chills and fever, chest and abdominal fullness, etc. The *Illustrated Materia Medica* records it as the most important medicine for treating vomiting due to spleen and stomach ailments. In the treatment of radiation enteritis, patchouli can invigorate the spleen and resolve dampness to relieve the dampness trapping the middle jiao; secondly, it can release exterior pathogens and disperse stagnation.

[0036] Eupatorium fortunei: The dried aerial parts of the plant Eupatorium fortunei (family Asteraceae); pungent in taste and neutral in nature. It enters the spleen, stomach, and lung meridians; it has the functions of aromatically resolving dampness, invigorating the spleen and stomach, releasing exterior pathogens and relieving summer heat; it is mainly used to treat dampness obstructing the middle jiao, epigastric fullness and nausea, sweet and greasy taste in the mouth, halitosis, excessive salivation, summer-dampness exterior syndrome, early stage of damp-heat syndrome, fever, fatigue, and chest tightness. In the treatment of radiation enteritis, Eupatorium fortunei can resolve dampness, invigorate the spleen, and indirectly stop diarrhea to relieve symptoms of loose stools.

[0037] Dandelion: The dried whole herb of *Taraxacum mongolicum*, a plant in the Asteraceae family; bitter, sweet, and cold in nature. It enters the liver and stomach meridians; it has the functions of clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting urination; it is mainly used to treat boils, carbuncles, mastitis, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and painful urination due to heat. In the treatment of radiation enteritis, dandelion can: 1) clear heat and detoxify, directly suppressing fire toxins to clear the intestinal tract of rampant inflammation; 2) reduce swelling and dissipate nodules, promote tissue regeneration and wound healing to repair eroded intestinal membranes; and 3) promote urination and eliminate dampness, separating clear from turbid fluids to guide damp-heat pathogens from the lower abdomen and intestines.

[0038] Agrimony: The dried aerial parts of Agrimony, a plant in the Rosaceae family; bitter, astringent, and neutral in nature. It enters the Heart and Liver meridians; it has astringent and hemostatic functions, treats malaria, stops dysentery, detoxifies, and tonifies deficiency. The *Bai Cao Jing* records that it lowers qi and invigorates blood, treats various diseases, and disperses abdominal distension; it is used for vomiting blood from falls, metrorrhagia, dysentery, and intestinal bleeding. In the treatment of radiation enteritis, Agrimony has the following effects: 1. It can astringe and stop bleeding, cool the blood and calm the collaterals to consolidate blood damaged in the intestinal collaterals; 2. It can astringe the intestines and stop dysentery, consolidate and prevent prolapse, to treat chronic diarrhea and dysentery; 3. It can tonify deficiency and strengthen the body, replenish qi and support the body's resistance, to restore the body's vital energy and blood.

[0039] *Sargentodoxa cuneata* (also known as *Sargentodoxa cuneata* var. *majorticoides*): The dried stem of this plant, belonging to the Lardizabalaceae family; bitter in taste and neutral in nature. It enters the large intestine and liver meridians; possessing the functions of clearing heat and detoxifying, promoting blood circulation, dispelling wind, and relieving pain. It is mainly used to treat intestinal abscesses and abdominal pain, sores caused by heat toxins, amenorrhea, dysmenorrhea, traumatic swelling and pain, and rheumatic pain. The *Illustrated Materia Medica* records that it "attacks blood stasis and treats blood clots." In the treatment of radiation enteritis, *Sargentodoxa cuneata* can clear heat and detoxify, disperse nodules and reduce swelling, thus relieving the accumulation of heat toxins in the intestines; secondly, it can promote blood circulation, remove blood stasis, and relieve pain, thus breaking up local blood stasis in the intestines.

[0040] Sanguisorba officinalis: the dried root of Sanguisorba officinalis, a plant in the Rosaceae family; bitter, sour, astringent, and slightly cold in nature. It enters the liver and large intestine meridians; it has the functions of cooling the blood and stopping bleeding, detoxifying and astringing sores; it is mainly used to treat hematochezia, hemorrhoidal bleeding, bloody dysentery, metrorrhagia, burns, carbuncles, and boils; the *Shennong Bencao Jing* records that it treats breast pain in women, seven types of injuries, leukorrhea, relieves pain, removes necrotic tissue, stops sweating, and heals wounds. In the treatment of radiation enteritis, Sanguisorba officinalis can: 1) cool the blood and clear heat, directly suppressing the fire to clear the excessive heat in the blood; 2) astringe and consolidate, reaching directly to the lower burner to consolidate the spilled blood from injury; and 3) detoxify, astringe sores, promote tissue regeneration, and protect the intestinal lining to repair eroded sores.

[0041] Sophora japonica flower: The dried flowers and buds of the Sophora japonica plant (family Fabaceae); bitter, slightly cold. It enters the liver and large intestine meridians; it has the functions of cooling the blood and stopping bleeding, clearing liver heat and purging fire. According to *Pharmacopoeia of Chinese Herbal Medicines*, Sophora japonica flower is bitter, and bitterness can directly purge blood; it is also thick and heavy, mainly used to clear intestinal bleeding, hemorrhoids, and intestinal bleeding. In the treatment of radiation enteritis, Sophora japonica flower can cool the blood and calm the meridians, clear heat and stop bleeding to soothe the blood flowing erratically in the intestines; secondly, it can dispel wind and clear heat, effectively treating intestinal wind to stabilize the exacerbation of wind and fire.

[0042] Cattail pollen charcoal: made from the dried pollen of plants such as Typha orientalis (family Typhaceae), which is charred by stir-frying. It is sweet and neutral in nature. It enters the liver and pericardium meridians; it has hemostatic, blood-activating, and urinary tract-clearing functions; it is mainly used to treat hematemesis, epistaxis, hemoptysis, metrorrhagia, traumatic bleeding, amenorrhea, dysmenorrhea, chest and abdominal pain, traumatic swelling and pain, and painful hematuria. The *Compendium of Materia Medica* records: "Cattail pollen is cool in nature and has a diuretic effect. It can cleanse the bladder and clear the qi of the small intestine, therefore it is a must-have for treating urinary retention." In the treatment of radiation enteritis, cattail pollen charcoal can astringe and directly reach the affected area to protect the damaged and eroded intestinal lining; secondly, it can invigorate blood circulation, relieve pain, and clear the intestinal tract to alleviate abdominal pain caused by blood stasis.

[0043] Alisma plantago-aquatica (Ze Xie): The dried tuber of Alisma plantago-aquatica (Ze Xie), a plant in the Alismataceae family; sweet and bland in taste, cold in nature. It enters the kidney and bladder meridians; it has the functions of promoting diuresis and eliminating dampness, clearing heat, resolving turbidity and lowering lipids; it is mainly used to treat dysuria, edema, diarrhea with scanty urine, phlegm retention and dizziness, painful urination due to heat, and hyperlipidemia; *Ben Cao Yan Yi* records that its effect is particularly good at promoting diuresis. In the treatment of radiation enteritis, Alisma plantago-aquatica can, firstly, promote diuresis and eliminate dampness, separating clear from turbid, to guide the damp heat flowing down into the intestines; secondly, it can clear heat, strengthen yin, and clear the ministerial fire, to eliminate the vexation and heat caused by yin deficiency and dampness.

[0044] The formulation of this invention is as follows: Kudzu root is the chief ingredient, used to invigorate the spleen and stomach, clear heat, and stop diarrhea. It also promotes fluid production, clears heat, and guides the medicinal effects to the spleen, stomach, and intestines. Coptis chinensis and Scutellaria baicalensis, being bitter and cold, directly clear damp-heat in the intestines, enhancing their heat-clearing power; these are the assistant ingredients. Patchouli, Eupatorium fortunei, and Aucklandia lappa are aromatic and invigorate the spleen, promoting qi circulation and resolving dampness to relieve fullness in the middle jiao. Alisma plantago-aquatica is mildly diuretic, guiding pathogens out through urination. Taraxacum mongolicum and Sargentodoxa cuneata clear deep-seated heat toxins and stagnation in the intestines. Agrimonia pilosa, Sanguisorba officinalis, Sophora japonica, and Typha orientalis pollen (charred) enter the blood level, combining blood-cooling, astringent, and blood-stasis-resolving properties, specifically addressing hematochezia caused by blood loss due to collateral damage. All of the above are adjuvant ingredients. The combined effects of these herbs clear heat and detoxify, promote blood circulation and stop bleeding, and prevent blood stasis. Together, they achieve the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, and resolving dampness and stopping diarrhea. This clears away heat and toxins, calms the blood vessels, and promotes the smooth flow of qi and dampness, thus alleviating the symptoms of radiation enteritis.

[0045] Pharmacodynamics Trial 1: The therapeutic effect of this invention on chronic radiation enteritis was evaluated through animal experiments. Fifty healthy male SPF-grade SD rats, aged 6-8 weeks and weighing approximately 200-220g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. They were housed in an SPF-grade animal laboratory with relative humidity controlled at 30%-60%, temperature controlled at 20-24℃, and a 12h / 12h light / dark cycle. After 7 days of acclimatization, the 50 rats were randomly divided into 5 groups using a random number table: blank control group, model group, low-dose traditional Chinese medicine group, medium-dose traditional Chinese medicine group, and high-dose traditional Chinese medicine group.

[0046] The experimental drugs were the traditional Chinese medicine formula prepared in Example 4 of this invention and physiological saline. The experimental instruments included a low-temperature high-speed centrifuge (Beijing Medical Centrifuge Factory, model LD5-2A), an ELISA reader (Manufactured in China, Designed in California, USA, SMP500-18272-LSIO), and an AE-240 electronic balance (Mettler Toledo).

[0047] Except for the blank control group, rats in the other groups were anesthetized with sodium pentobarbital, fixed in a supine position, and subjected to a single irradiation of the lower abdomen (from the pubic symphysis to the anus, with an irradiation field of approximately 3 cm × 4 cm) using 6 MV X-rays at a dose of 10 Gy (dose rate 400 cGy / min, source-skin distance 100 cm). Diarrhea, mucopurulent bloody stools, and rectal pathological changes were considered successful model establishment after irradiation.

[0048] The day after successful model establishment, drug administration began and continued for 14 days, once daily. To ensure full drug absorption, the rats emptied their bladder and bowels before the enema. After anesthetizing and fixing the rats, the enema solution was inserted approximately 2 cm into the rat's anus (pre-lubricated) using a syringe through a pediatric catheter. The solution was pushed in at a uniform rate, and the catheter was then withdrawn and held in place for 20 minutes. The low, medium, and high dose groups were each given 1.5 mL of a different concentration of traditional Chinese medicine enema (prepared in Example 4 of this invention) rectally, equivalent to 0.1 times, 1 times, and 2 times the clinically equivalent dose, respectively. The blank control group and the model group received an equal volume of 0.9% sodium chloride injection.

[0049] Rats were observed daily for general physical signs such as food and water intake, defecation, and free movement. The scoring criteria for general physical signs are as follows: 1 point: Formed stool, intact anal skin, normal food and water intake, no weight loss, normal activity, and smooth, clean fur; 2 points: Unformed, mucous stool, hair loss area perianal <0.5 cm in diameter, slightly reduced food and water intake, weight loss of 1-2 g, reduced activity, and slightly less smooth fur; 3 points: Diarrhea, mucous and bloody stool, hair loss area perianal 0.5-1.0 cm in diameter, significantly reduced food and water intake, weight loss of 2-3 g, occasional curling up, reduced activity, and significantly less smooth fur; 4 points: Diarrhea, watery stool and / or excessive mucus, hair loss area perianal >1.0 cm in diameter, refusal to eat or drink, weight loss >3 g, curling up and less moving, with bending and twisting movements, and dull fur.

[0050] After treatment, rectal tissue was collected from rats for pathological examination. The rats were graded according to the pathological state of radiation-induced proctitis, and a rectal pathological damage score was calculated: Grade 0: Normal rectal mucosa, 0 points; Grade 1: Very minor damage, very minor rectal inflammation and / or very minor rectal gland damage, 1 point; Grade 2: Mild damage, rectal inflammation or glandular changes are more pronounced than Grade 1, 2 points; Grade 3: Moderate damage, significant rectal epithelial shedding, 3 points; Grade 4: Severe damage, ulceration or necrosis, 4 points.

[0051] After the last administration, carotid artery blood samples were collected from rats and allowed to stand. After the serum was separated, the samples were centrifuged at 3000 r / min for 15 min at 4℃. The serum was collected and the levels of IL-6, IL-8, IL-10 and TNF-α in rat serum were detected using an ELISA kit.

[0052] The experimental results are as follows: General physical signs: Control group rats showed good mental state, normal activity, stable food and water intake, steady weight gain, and thick, glossy fur. Model group rats, however, exhibited reduced food and water intake, weight loss, decreased activity, sluggishness, dull and disheveled fur, and abnormal symptoms such as loose stools, mucus stools, or bloody stools. General physical signs were significantly improved in all treatment groups (low, medium, and high doses) compared to the model group. General physical sign scores showed that the model group was significantly higher than the control group (P<0.001); all treatment groups were significantly lower than the model group (P<0.001); the medium and high dose groups were significantly lower than the low dose group (P<0.001); and the high dose group was also significantly lower than the medium dose group (P<0.001). Results are shown in Table 1. Figure 1 As shown; where, the symbol ### Compared with the control group, P < 0.001; symbol *** Compared with the model group, P<0.001; Con is the control group, Model is the model group; GCY-L is the low-dose enema solution of the present invention, GCY-M is the medium-dose enema solution of the present invention, and GCY-H is the high-dose enema solution of the present invention.

[0053] Rectal pathological damage: In the control group, the rectal tissue morphology of rats was normal, the intestinal epithelial cells were neatly arranged, the intestinal villi structure was clear, and no obvious pathological damage was observed. In contrast, the model group rats showed dilation or disappearance of rectal mucosal crypt structures, a reduction in goblet cells, mucosal necrosis, epithelial atrophy, glandular structure destruction, accompanied by ulceration and extensive neutrophil infiltration, with obvious local congestion and edema. Rectal pathological damage in all treatment groups (low, medium, and high doses) was improved to varying degrees, with the overall pathological grade lower than that in the model group. The results of rectal tissue pathological damage scoring showed that the model group was significantly higher than the control group (P<0.001); all treatment groups were significantly lower than the model group (P<0.001); the medium and high dose groups were significantly lower than the low dose group (P<0.001); and the high dose group was also significantly lower than the medium dose group (P<0.001). The results are shown in Table 2. Figure 2 As shown; where, the symbol ### Compared with the control group, P < 0.001; symbol ***Compared with the model group, P<0.001; Con is the control group, Model is the model group, GCY-L is the low-dose enema solution of the present invention, GCY-M is the medium-dose enema solution of the present invention, and GCY-H is the high-dose enema solution of the present invention.

[0054] Inflammatory factor levels: Serum IL-6, IL-8, and TNF-α levels in the model group rats were significantly higher than those in the control group, while IL-10 levels were significantly lower (P<0.001). Compared with the model group, IL-6, IL-8, and TNF-α levels were significantly decreased in all dose groups, while IL-10 levels were significantly increased (P<0.001). Further comparisons showed that the high-dose group was superior to the low-dose and medium-dose groups in reducing pro-inflammatory factors (IL-6, IL-8, TNF-α) and increasing the anti-inflammatory factor IL-10 (P<0.001). Results are shown in Table 3. Figure 3 As shown; Figure 3 (A)- Figure 3 (D) Shows the changes in the levels of IL-6, IL-8, IL-10, and TNF-α; where the symbols... ### Compared with the control group, P < 0.001; symbol *** Compared with the model group, P<0.001; Con is the control group, Model is the model group; GCY-L is the low-dose enema solution of the present invention, GCY-M is the medium-dose enema solution of the present invention, and GCY-H is the high-dose enema solution of the present invention.

[0055] The results of this experiment demonstrate that the herbal enema solution provided by this invention can significantly improve the general condition of rats with chronic radiation enteritis, reducing symptoms such as diarrhea and hematochezia. Its mechanism of action may be related to regulating the body's inflammatory response balance, specifically downregulating the expression of pro-inflammatory factors (IL-6, IL-8, TNF-α) and upregulating the expression of anti-inflammatory factors (IL-10). Simultaneously, this formula can effectively alleviate pathological damage to radiation-induced rectal tissue. These results validate the efficacy and dose-response relationship of the drug in this invention in animal models, providing a pharmacological basis for its clinical application.

[0056] Pharmacodynamics Experiment 2: To clinically observe the efficacy and safety of this invention in treating radiation enteritis, 122 patients with radiation enteritis complicated by histologically or cytologically confirmed malignant tumors were selected and randomly divided into a traditional Chinese medicine treatment group and a control group. The treatment group consisted of 62 patients (22 males and 40 females), aged 39–65 years (mean age 48.5 years), including 20 cases of cervical cancer, 18 cases of ovarian cancer, 8 cases of prostate cancer, 10 cases of rectal cancer, and 6 cases of renal cancer; 12 cases had mild diarrhea, 37 cases had moderate diarrhea, 8 cases had severe diarrhea, and 5 cases had extremely severe diarrhea. The control group consisted of 60 patients (20 males and 40 females), aged 41–66 years (mean age 49.8 years), including 24 cases of cervical cancer, 16 cases of rectal cancer, 12 cases of colon cancer, and 8 cases of ovarian cancer; 14 cases had mild diarrhea, 30 cases had moderate diarrhea, 10 cases had severe diarrhea, and 6 cases had extremely severe diarrhea. The severity of diarrhea in clinical manifestations is defined as follows: 3-4 times / day is mild, 5-8 times / day is moderate, 9-10 times / day is severe, and >10 times / day is extremely severe. Fiberoptic colonoscopy of enrolled patients revealed intestinal mucosal congestion and edema, erosion or ulceration, secretions, and bleeding.

[0057] The treatment methods are as follows: The treatment group used the traditional Chinese medicine formula prepared in Example 4 of this invention. 60-80 ml of the medicine solution was taken, and the temperature was controlled at 35-40℃. Patients were instructed to empty their bowels and bladder before bedtime and undergo a cleansing enema. They were then placed in a left lateral decubitus position with their hips elevated at a 30-degree angle. The medicine solution was injected through a 16-18 gauge catheter using a syringe and retained for at least 6 hours, once daily. The control group used a Western medicine enema solution (60 ml of normal saline plus 10 berberine tablets and 5 mg of dexamethasone), once daily. The treatment course for both groups was 14 days.

[0058] The efficacy evaluation criteria are divided into cure, improvement, and ineffectiveness. Cure: Clinical symptoms disappear, one bowel movement per day, negative stool routine and occult blood test, and colonoscopy showing that the lesioned mucosa has returned to normal or only scarring remains; Improvement: Symptoms are significantly reduced, the number of bowel movements per day decreases to less than four, negative stool routine, positive occult blood test, and colonoscopy showing reduced mucosal lesions; Ineffectiveness: Symptoms do not significantly improve, stool still contains mucus or pus and blood, and colonoscopy shows no improvement or worsening.

[0059] There were no statistically significant differences in gender, age, disease duration, and diarrhea severity between the two groups (P>0.05), indicating comparability. The results showed that after treatment, the distribution of diarrhea severity (mild, moderate, severe, and extremely severe) in the traditional Chinese medicine treatment group was significantly improved compared to the control group, with statistically significant differences between the groups (P<0.05), as shown in Table 4.

[0060] Post-treatment evaluation showed that the total effective rate in the traditional Chinese medicine treatment group was 95.2% (59 / 62), which was significantly better than the 80.0% (48 / 60) in the control group, and the difference was statistically significant (P<0.05). The results are shown in Table 5.

[0061] During the treatment period, the incidence of adverse reactions in the traditional Chinese medicine treatment group was 1.6% (1 / 62, manifested as mild abdominal pain), which was significantly lower than that in the control group (15.0% (9 / 60, including rash, nausea / vomiting, and abdominal pain), and the difference was statistically significant (P<0.05). The results are shown in Table 6.

[0062] The above clinical research results show that, compared with conventional Western medicine enema regimens, the use of the traditional Chinese medicine enema solution described in this invention to treat radiation enteritis can more effectively reduce the severity of diarrhea in patients, has a higher overall clinical effective rate, and significantly reduces the incidence of adverse reactions, demonstrating good efficacy and safety.

[0063] Toxicity testing: The pharmacological toxicity of the present invention was evaluated through animal experiments.

[0064] The toxicity of the decoction prepared according to Example 4 was assessed.

[0065] Methods: Eighteen rats, half male and half female, were selected and fasted overnight. To ensure adequate drug absorption, the rats emptied their bladder and bowels before the enema. After anesthetizing and fixing the rats, the enema solution was inserted approximately 2 cm into the rat's anus using a syringe through a pediatric catheter (pre-lubricated). The solution was injected at a uniform rate, and the catheter was then withdrawn and left in place for 20 minutes. Different concentrations of the herbal enema solution (prepared in Example 4 of this invention) were administered rectally at 1.5 mL each, equivalent to 1 times (crude drug: 14.2 g / kg), 2 times (crude drug: 28.4 g / kg), and 4 times (crude drug: 56.8 g / kg) of the clinically equivalent dose, respectively. Immediately after administration, the animals' symptoms of poisoning (mental state, motor function, etc.) and mortality were observed and recorded. The observation period was 7 days.

[0066] Results: No obvious toxicity was observed in the mixture (see Table 7).

[0067] The results of this experiment show that the traditional Chinese medicine enema solution provided by this invention is safe and has no obvious acute toxicological reactions, providing a toxicological basis for its clinical application.

[0068] The various embodiments in this specification are described in a related manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, the system embodiments are basically similar to the method embodiments, so the description is relatively simple; relevant parts can be referred to the descriptions of the method embodiments.

[0069] The above description is merely a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention are included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine formula for treating radiation enteritis, characterized in that, The raw medicinal materials comprise the following mass proportions Composition: Pueraria 10-15g, Coptis 9-12g, Scutellaria 6-15g, Saussurea 6-10g, Pogostemon 5-10g, Pterocephalus 8-12g, Taraxacum 20-25g, Agrimonia 15-20g, Sargentodoxa 15-25g, Hippophae 5-15g, Sophora 6-10g, Typha 5-10g, Alisma 10-20g.

2. The traditional Chinese medicine prescription for treating radiation enteritis according to claim 1, characterized in that, The raw medicinal materials comprise the following mass proportions Pueraria 10g, Coptis 10g, Scutellaria 6g, Saussurea 8g, Pogostemon 5g, Pterocephalus 10g, Taraxacum 20g, Agrimonia 20g, Sargentodoxa 20g, Hippophae 5g, Sophora 6g, Typha 5g, Alisma 10g.

3. The preparation method of the traditional Chinese medicine formula for treating radiation enteritis according to claim 1 or 2, characterized in that, The method comprises the following steps: (1) according to the mass ratio, the raw medicinal materials of the traditional Chinese medicine prescription are weighed, and then soaked in water and decocted, and the decoction is combined; (2) the decoction is filtered and centrifuged; (3) the centrifuged medicinal liquid is reduced pressure concentrated to a clear paste with a relative density of 1.03-1.12 at 60℃; (4) a preservative is added to the clear paste, and the volume is adjusted with water, then stirred uniformly, filtered and filled, and the finished product is obtained.

4. The preparation method of the traditional Chinese medicine prescription for treating radiation enteritis according to claim 3, characterized in that, In step (1), the water is added and soaked for 30-60 minutes, and decocted under normal pressure at 100℃ for 2-3 times; wherein, the water added for the first time is 6-10 times the total mass of medicinal materials, and decocted for 1.5-2.0 hours; the water added for the second time is 6-8 times the total mass of medicinal materials, and decocted for 1.0-1.5 hours; the water added for the third time is 5-7 times the total mass of medicinal materials, and decocted for 1.0-1.5 hours.

5. The preparation method of the traditional Chinese medicine prescription for treating radiation enteritis according to claim 3, characterized in that, In step (2), the decoction is filtered through a 100-200 mesh filter screen, and the obtained filtrate is centrifuged online at a speed of 15000-25000 r / min.

6. The preparation method of the traditional Chinese medicine prescription for treating radiation enteritis according to claim 3, characterized in that, In step (3), the operation is carried out under the conditions of a vacuum degree of-0.05 MPa to-0.10 MPa and a temperature of 60℃ to 70℃.

7. The preparation method of the traditional Chinese medicine prescription for treating radiation enteritis according to claim 3, characterized in that, In step (4), the preservative is sodium benzoate, and the addition amount of the sodium benzoate is 2g per 1000mL of the finished product.

8. Use of the traditional Chinese medicine prescription according to any one of claims 1-2 in the preparation of a medicament for treating radiation enteritis.

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