A traditional Chinese medicine compound composition and preparation for treating acute radiation cystitis and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine compound composition, preparation and a preparation method thereof for treating acute radiation cystitis, and belongs to the technical field of medicines. The traditional Chinese medicine compound composition for treating acute radiation cystitis is prepared based on the screening of compound components by means of modern molecular biology and the theory of traditional Chinese medicine compound, and is prepared from Lysimachia christinae 2-4 parts, Herba Epimedii 1-3 parts, Herba Patriniae 2-4 parts, Smilax glabra 2-4 parts, Sophora flavescens 0.8-2.8 parts, Lobelia 1-3 parts, Semen Lagenariae 1.4-3.4 parts, Hippophae rhamnoides 1-3 parts, Herba Erigerontis 1-3 parts and Glycyrrhiza 1-3 parts by extraction. The traditional Chinese medicine compound can solve the problems of lack of targeted mechanism intervention, limited curative effect, large side effect and poor patient compliance in the prior art; in addition, the application proposes key target points and effective components of drugs for treating acute radiation cystitis, and experiments prove that the treatment effect on acute radiation cystitis is obvious.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine compound composition, preparation and preparation method for treating acute radiation cystitis. Background Technology

[0002] Acute radiation cystitis is a common acute side effect of radiation therapy for pelvic tumor patients, manifesting as urinary frequency, urgency, dysuria, and hematuria. In severe cases, it can lead to a significant decrease in bladder capacity, bladder wall fibrosis, and even urinary retention, severely impacting patients' quality of life. Current bladder instillation methods require frequent and complex procedures, and some patients experience significant bladder irritation symptoms during instillation, resulting in poor compliance. Hyperbaric oxygen therapy has a long cycle, high cost, high equipment requirements, and is difficult to popularize, and its efficacy is limited for some patients. Non-steroidal anti-inflammatory drugs (NSAIDs), flavonoids, and other anti-inflammatory or antioxidant drugs have low bioavailability in local bladder tissue and limited efficacy. Based on these shortcomings, developing a standard drug that targets the molecular mechanisms of radiation-induced bladder injury, targets multiple sites, and systematically regulates local inflammation, oxidative stress, and tissue damage has become a pressing technical problem that needs to be solved. Summary of the Invention

[0003] Based on the technical problems to be solved by the present invention, the present invention proposes a traditional Chinese medicine compound composition, preparation and preparation method for treating acute radiation cystitis by screening compound ingredients using modern molecular biology methods and combining them with the theory of traditional Chinese medicine compound prescriptions.

[0004] One of the objectives of this invention is to provide a traditional Chinese medicine compound composition for treating acute radiation cystitis. The traditional Chinese medicine compound composition is prepared by extraction of 2-4 parts of Lysimachia christinae, 1-3 parts of Epimedium, 2-4 parts of Patrinia scabiosaefolia, 2-4 parts of Smilax glabra, 0.8-2.8 parts of Sophora flavescens, 1-3 parts of Lobelia chinensis, 1.4-3.4 parts of Cuscuta chinensis, 1-3 parts of Hippophae rhamnoides, 1-3 parts of Erigeron breviscapus, and 1-3 parts of Glycyrrhiza uralensis, according to the weight percentages.

[0005] Furthermore, the traditional Chinese medicine compound composition is prepared by extraction of 2.5-3.5 parts of Lysimachia christinae, 1.5-2.5 parts of Epimedium brevicornu, 2.5-3.5 parts of Patrinia scabiosaefolia, 2.5-3.5 parts of Smilax glabra, 1.3-2.3 parts of Sophora flavescens, 1.5-2.5 parts of Lobelia chinensis, 1.9-2.9 parts of Cuscuta chinensis, 1.5-2.5 parts of Hippophae rhamnoides, 1.5-2.5 parts of Erigeron breviscapus, and 1.5-2.5 parts of Glycyrrhiza uralensis, according to the weight parts.

[0006] Furthermore, the traditional Chinese medicine compound composition is prepared by extraction of 3 parts of Lysimachia christinae, 2 parts of Epimedium, 3 parts of Patrinia scabiosaefolia, 3 parts of Smilax glabra, 1.8 parts of Sophora flavescens, 2 parts of Lobelia chinensis, 2.4 parts of Cuscuta chinensis, 2 parts of Hippophae rhamnoides, 2 parts of Asarum sieboldii, and 2 parts of Glycyrrhiza uralensis, according to the weight parts.

[0007] The second objective of this invention is to provide a traditional Chinese medicine compound preparation for treating acute radiation cystitis.

[0008] Furthermore, the traditional Chinese medicine compound preparations include oral solutions, tablets, and granules.

[0009] Furthermore, the pharmaceutical excipient is a pharmaceutically acceptable excipient.

[0010] The third objective of this invention is to provide a method for preparing a traditional Chinese medicine compound preparation for treating acute radiation cystitis, comprising the following steps.

[0011] S1. Weigh the following ingredients according to the following weight ratio: Lysimachia christinae: Epimedium: Patrinia scabiosaefolia: Smilax glabra: Sophora flavescens: Lobelia chinensis: Cuscuta chinensis: Hippophae rhamnoides: Asarum sieboldii: Glycyrrhiza uralensis = (2~4): (1~3): (2~4): (2~4): (0.8~2.8): (1~3): (1.4~3.4): (1~3): (1~3): (1~3) to obtain the weighed compound Chinese medicine composition.

[0012] S2. Add 8-12 times the volume of water to the weighed traditional Chinese medicine compound composition and soak for 20-40 minutes to obtain the soaked traditional Chinese medicine compound composition. The water addition ratio and soaking time mentioned in this invention were determined through experimental optimization. Based on multiple experimental comparisons of the effects of different water addition ratios (6 times, 8 times, 10 times, 12 times, 14 times) on the extraction rate, the results showed that when the water addition ratio was less than 8 times, the concentration of the medicinal solution was too high, the local decoction was uneven, and the extraction rate of some components decreased; while exceeding 12 times led to dilution of the medicinal solution, a decrease in the concentration of effective components, and a decrease in the overall efficacy and extraction efficiency. This invention determined that the water volume should be 8-12 times the weight of the medicinal material. Experiments comparing the effects of soaking for 10, 20, 30, 40, and 60 minutes on the content of major components (such as flavonoids and polysaccharides) in the extract showed that soaking for 20–40 minutes allowed the medicinal materials to fully absorb water and swell, softening the cell walls and facilitating the subsequent dissolution of components, thus improving the yield and stability of the extract. Approximately 30 minutes was identified as the optimal balance point between water absorption and dissolution; therefore, this invention determined the optimal soaking time to be 20–40 minutes. Using the above-mentioned water addition ratio and soaking time ensures more complete extraction of the active ingredients in the compound, stable extract concentration, reduced batch-to-batch fluctuations, and improved bioactivity and efficacy consistency of the compound. It also avoids prolonged soaking leading to oxidation or hydrolysis of some components, thus guaranteeing the quality of the preparation.

[0013] S3. The soaked herbal compound composition is heated and decocted, the decoctions are combined and filtered to obtain a decocted and filtered extract of the herbal compound composition. Insufficient decoction can easily lead to incomplete dissolution of the active ingredients, while excessive time can cause degradation of some heat-sensitive components. The number of heating and decoction times selected in this invention can significantly improve the extraction rate and concentration stability of the active ingredients in the compound, and the decoction is uniform in color, clear and transparent; at the same time, it reduces energy consumption and operation time, and ensures the stability of efficacy and the repeatability of the process.

[0014] S4. The extract of the decocted and filtered traditional Chinese medicine compound composition is concentrated, and then processed into a formulation, quality controlled, packaged, and sterilized to obtain the traditional Chinese medicine compound preparation. This process can significantly improve the purity and stability of the powder. The preparation obtained after freeze-drying is a light yellow, loose powder that is easy to store and reconstitute, with good solubility and small batch-to-batch variation. Compared with traditional atmospheric pressure concentration or hot air drying, the retention rate of active ingredients is increased by about 15% to 25%, the efficacy is enhanced, and the shelf life and transport stability of the preparation are extended.

[0015] Furthermore, the heating and decoction is performed 2-3 times, each time for 30-45 minutes. Experiments comparing different decoction times (1-3 times), times (20-60 minutes), and water addition ratios (6-12 times) revealed that when the decoction frequency was 2-3 times and each time for 30-45 minutes, the extraction rate of the main active ingredients (such as flavonoids, polysaccharides, and saponins) was the highest, with the smallest batch-to-batch variation. These decoction parameters were determined through single-factor optimization experiments. When the number of decoctions was less than 2, the effective components in the medicinal materials were not fully released; when it exceeded 3 times, the extraction rate did not improve significantly and energy consumption increased. When the time was less than 30 minutes, the dissolution rate was insufficient; when it was more than 45 minutes, partial degradation of flavonoids was detected. This time and number of decoctions achieve a balance between the dissolution of the active ingredients and the stability of the components, improving the extraction efficiency by approximately 15-25%, ensuring the consistency of the preparation quality and the reliability of the efficacy.

[0016] The fourth objective of this invention is to provide the application of a traditional Chinese medicine compound preparation for treating acute radiation cystitis in the preparation of drugs for treating acute radiation cystitis.

[0017] Furthermore, the aforementioned traditional Chinese medicine compound preparation is administered orally once daily, divided into three doses. This dosing regimen was determined based on animal experiments and clinical experience in traditional Chinese medicine. Comparison of different dosing frequencies (once, twice, and three times daily) revealed that divided dosing maintains stable blood drug concentrations, ensuring the sustained effect of the active ingredients in the compound within the body. Given that the duration of drug metabolism and pharmacological effects in the body is approximately 6–8 hours, choosing to administer one dose daily, divided into three doses, maintains continuous efficacy, enhances absorption and utilization, significantly improves treatment compliance and safety, and ensures stable efficacy throughout the day and night without fluctuations in drug potency. Following the traditional Chinese medicine principle of "small doses, frequent administration, and sustained nourishment," divided administration helps reduce gastrointestinal irritation from a single large dose, improving patient compliance and absorption efficiency. Compared to a single large dose, this dosing regimen can increase the bioavailability of the active ingredients by approximately 10%–20%, while reducing the risk of potential adverse reactions, ensuring stable and repeatable efficacy.

[0018] Compared with the prior art, the present invention proposes a traditional Chinese medicine compound composition, preparation and preparation method for treating acute radiation cystitis, which has the following beneficial effects:

[0019] The traditional Chinese medicine compound composition for acute radiation cystitis proposed in this invention can solve the problems of lack of targeted intervention, limited efficacy, large side effects and poor patient compliance in existing treatments.

[0020] Furthermore, this invention uses reverse network pharmacology to screen key targets and effective drug components for the treatment of acute radiation cystitis. It is designed in combination with the theory of syndrome differentiation and treatment in traditional Chinese medicine and the principle of "principal, assistant, adjuvant and guide" in drug formulation. It has comprehensive effects such as clearing heat and detoxifying, promoting diuresis and relieving strangury, and promoting blood circulation and removing blood stasis. It can regulate the functions of the internal organs as a whole, reduce bladder tissue damage, promote repair, and improve bladder function indicators. This invention proposes a traditional Chinese medicine compound composition and preparation with multiple targets, systemic effect, and high safety for the treatment of acute radiation cystitis. Attached Figure Description

[0021] Figure 1 A Venn diagram of a radiation cystitis disease target according to an embodiment of the present invention is shown.

[0022] Figure 2 This invention illustrates a core target map of disease targets in a disease database according to an embodiment of the present invention.

[0023] Figure 3 This diagram illustrates a screening map of core targets for differentially expressed genes in single-cell transcriptome data according to an embodiment of the present invention.

[0024] Figure 4 This diagram illustrates a screening map of core targets for differentially expressed genes in ordinary transcriptome data according to an embodiment of the present invention.

[0025] Figure 5 This paper illustrates a "target-compound-traditional Chinese medicine" network diagram according to an embodiment of the present invention.

[0026] Figure 6 A forward network pharmacology analysis diagram of a traditional Chinese medicine compound according to an embodiment of the present invention is shown.

[0027] Figure 7 This illustrates a verification of forward and reverse network pharmacology in an embodiment of the present invention—a core target intersection diagram.

[0028] Figure 8 This illustrates a verification of forward and reverse network pharmacology—a core compound intersection diagram—based on an embodiment of the present invention.

[0029] Figure 9 This diagram illustrates the target GO enrichment analysis of a traditional Chinese medicine compound composition in a network pharmacology analysis according to an embodiment of the present invention.

[0030] Figure 10 This diagram illustrates the KEGG enrichment analysis of a traditional Chinese medicine compound composition as a target in a network pharmacology analysis according to an embodiment of the present invention.

[0031] Figure 11 The image shows the appearance of bladder tissue after 14 days of treatment with a traditional Chinese medicine compound composition according to an embodiment of the present invention for acute cystitis.

[0032] Figure 12 A pressure measurement diagram of a leakage point according to an embodiment of the present invention is shown.

[0033] Figure 13 A graph showing the measurement of bladder capacity after 14 days of medication according to an embodiment of the present invention is shown.

[0034] Figure 14 A urine analysis diagram according to an embodiment of the present invention is shown.

[0035] Figure 15 This diagram illustrates a pathological staining analysis according to an embodiment of the present invention.

[0036] Figure 16 The diagram shows a transmission electron microscope analysis of an embodiment of the present invention, wherein (a) is the normal group; (b) is the model group; and (c) is the drug-treated group.

[0037] Figure 17 The present invention illustrates a pathological staining analysis of a major organ according to an embodiment of the present invention.

[0038] Figure 18 The diagram shows a measurement of bladder capacity after 14 days of medication according to an embodiment of the present invention, used to observe the improvement effect of the dosage of the compound drug relative to the model group.

[0039] Figure 19 The diagram shows a measurement of leakage point pressure after 14 days of medication according to an embodiment of the present invention, used to observe the improvement effect of the dosage of the compound drug relative to the model group.

[0040] Figure 20 The diagram shows a urine analysis of a patient after 14 days of medication according to an embodiment of the present invention, used to observe the improvement effect of the dosage of the compound drug relative to the model group.

[0041] Figure 21 The diagram shows a pathological staining analysis of the compound drug after 14 days of medication, in accordance with an embodiment of the present invention, to observe the improvement effect of the dosage relative to the model group.

[0042] Figure 22 The diagram shows a measurement of bladder capacity after 14 days of medication according to an embodiment of the present invention, used to observe the effect comparison of low, medium and high doses of compound drugs.

[0043] Figure 23 The diagram shows a measurement of the pressure at the leakage point after 14 days of medication according to an embodiment of the present invention, used to observe the effect comparison of low, medium and high doses of compound drugs.

[0044] Figure 24 The illustration shows a urine analysis chart after 14 days of medication according to an embodiment of the present invention, used to observe the effect comparison of low, medium and high doses of compound drugs.

[0045] Figure 25 The diagram shows a pathological staining analysis of the compound drug after 14 days of medication, according to an embodiment of the present invention, to observe the effect comparison of low, medium and high doses of the compound drug.

[0046] Figure 26 The diagram shows a measurement of bladder capacity after 14 days of medication according to an embodiment of the present invention, used to observe the improvement effect of the dosage of the compound drug relative to the dexamethasone treatment group.

[0047] Figure 27 The diagram shows a measurement of the pressure at the leakage point after 14 days of medication according to an embodiment of the present invention, used to observe the improvement effect of the dosage of the compound drug relative to the dexamethasone treatment group.

[0048] Figure 28 The diagram shows a urine analysis of a patient after 14 days of medication according to an embodiment of the present invention, used to observe the improvement effect of the compound drug at a specific dosage relative to the dexamethasone treatment group.

[0049] Figure 29 The diagram shows a pathological staining analysis of the compound drug at 14 days of medication, according to an embodiment of the present invention, to observe the improvement effect of the dosage of the compound drug relative to the dexamethasone treatment group.

[0050] Figure 30 The diagram shows bladder capacity measurements after 7 and 14 days of medication according to an embodiment of the present invention, used to observe the effect of the length of the treatment cycle on the recovery of bladder function.

[0051] Figure 31 The diagram shows pathological staining analysis images at 7 and 14 days of medication according to an embodiment of the present invention, used to observe the effect of the length of the treatment cycle on the repair effect of bladder pathological damage.

[0052] Figure 32 The figure shows a high-performance mass spectrometry (HPLC) analysis of a compound traditional Chinese medicine powder according to an embodiment of the present invention. Detailed Implementation

[0053] Exemplary embodiments of the present application will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present application are shown in the drawings, it should be understood that the present application may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the scope of the present application to those skilled in the art.

[0054] Unless otherwise specified, the technical means used in the following embodiments are conventional means well known to those skilled in the art, and the reagents and materials in this invention are obtained from the market or other public channels.

[0055] The experimental materials and equipment involved in this invention mainly include, but are not limited to:

[0056] Reagents (see Table 1):

[0057] Table 1. Information on Main Reagents

[0058]

[0059] Instruments (see Table 2):

[0060] Table 2 Main Instrument Information Table

[0061]

[0062] The present invention discloses a traditional Chinese medicine compound composition, preparation, and preparation method for treating acute radiation cystitis. The main technical principles of this invention include:

[0063] This invention provides a traditional Chinese medicine compound composition for treating acute radiation-induced cystitis. The composition is formulated based on a reverse network pharmacology method to screen disease-related core targets and their potential active ingredients, combined with the TCM syndrome differentiation of "kidney deficiency, damp-heat, and blood stasis" and the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine. It possesses the effects of clearing heat and detoxifying, promoting diuresis and relieving strangury, and activating blood circulation and removing blood stasis. This composition is used to relieve symptoms such as urinary frequency, urgency, dysuria, and hematuria caused by acute radiation-induced cystitis, regulate bladder function, protect mucosal structure, inhibit inflammatory responses, and promote bladder tissue repair.

[0064] This invention presents a traditional Chinese medicine compound composition, preparation, and preparation method for treating acute radiation cystitis, which has significant advantages over existing technologies: First, it has a clear targeting mechanism and multi-pathway synergistic intervention. This invention uses reverse network pharmacology to systematically screen core active ingredients from 58 core targets related to acute radiation cystitis, and formulates a compound based on traditional Chinese medicine theory. Network analysis and pathway enrichment results indicate that this compound can act on multiple key pathological processes such as inflammation, oxidative stress, apoptosis, and tissue repair, possessing multi-target and systemic regulatory effects. Second, animal experiments confirm its efficacy. Using a rat model of acute radiation cystitis constructed after radiotherapy, animal experimental results show that the bladder capacity of the treated rats significantly increased, and the leakage point pressure significantly increased, showing statistically significant differences compared to the model group. P <0.05); the levels of red blood cells, white blood cells, and protein in the urine were significantly reduced, indicating a reduction in bladder inflammation; HE and Masson staining showed that the bladder epithelial structure in the treatment group was more intact, collagen deposition was reduced, and inflammatory infiltration was significantly decreased; transmission electron microscopy revealed that the ultrastructure of the bladder epithelium in the treatment group was well restored, cell junctions were tight, and mitochondria were intact; transcriptome sequencing revealed that the treatment group was regulated in multiple signaling pathways, involving mechanisms such as cell repair, antioxidation, and immune regulation. Furthermore, it has high safety, good compliance, and is suitable for widespread application. The traditional Chinese medicine composition or preparation described in this invention is used for acute radiation cystitis. Compared with bladder instillation or hyperbaric oxygen therapy, this invention uses oral administration, the preparation is naturally derived, has few toxic side effects, and no obvious adverse reactions were observed in animal experiments, demonstrating good safety and acceptability. Finally, it is simple to prepare and can be industrially produced. This traditional Chinese medicine compound can be applied by decocting traditional Chinese medicine slices, or it can be further concentrated and dried to produce granules, tablets, and other formulations that meet the purpose of this invention.

[0065] Based on the above principles, this invention proposes a traditional Chinese medicine compound composition, preparation, and preparation method for treating acute radiation cystitis.

[0066] The traditional Chinese medicine compound composition of the present invention is prepared by extraction from 2-4 parts of Lysimachia christinae, 1-3 parts of Epimedium, 2-4 parts of Patrinia scabiosaefolia, 2-4 parts of Smilax glabra, 0.8-2.8 parts of Sophora flavescens, 1-3 parts of Lobelia chinensis, 1.4-3.4 parts of Cuscuta chinensis, 1-3 parts of Hippophae rhamnoides, 1-3 parts of Erigeron breviscapus, and 1-3 parts of Glycyrrhiza uralensis, according to the weight parts.

[0067] Furthermore, the traditional Chinese medicine compound composition is prepared by extraction of 2.5-3.5 parts of Lysimachia christinae, 1.5-2.5 parts of Epimedium brevicornu, 2.5-3.5 parts of Patrinia scabiosaefolia, 2.5-3.5 parts of Smilax glabra, 1.3-2.3 parts of Sophora flavescens, 1.5-2.5 parts of Lobelia chinensis, 1.9-2.9 parts of Cuscuta chinensis, 1.5-2.5 parts of Hippophae rhamnoides, 1.5-2.5 parts of Erigeron breviscapus, and 1.5-2.5 parts of Glycyrrhiza uralensis, according to the weight parts.

[0068] Furthermore, the traditional Chinese medicine compound composition is prepared by extraction of 3 parts of Lysimachia christinae, 2 parts of Epimedium, 3 parts of Patrinia scabiosaefolia, 3 parts of Smilax glabra, 1.8 parts of Sophora flavescens, 2 parts of Lobelia chinensis, 2.4 parts of Cuscuta chinensis, 2 parts of Hippophae rhamnoides, 2 parts of Asarum sieboldii, and 2 parts of Glycyrrhiza uralensis, according to the weight parts.

[0069] The traditional Chinese medicine compound preparation for treating acute radiation cystitis described in this invention includes mixtures, tablets, granules, and any other formulations that can satisfy the purpose of this invention.

[0070] The method for preparing the traditional Chinese medicine compound preparation for treating acute radiation cystitis according to the present invention includes:

[0071] S1. Weigh the following ingredients according to the following weight ratio: Lysimachia christinae: Epimedium: Patrinia scabiosaefolia: Smilax glabra: Sophora flavescens: Lobelia chinensis: Cuscuta chinensis: Hippophae rhamnoides: Asarum sieboldii: Glycyrrhiza uralensis = (2~4): (1~3): (2~4): (2~4): (0.8~2.8): (1~3): (1.4~3.4): (1~3): (1~3): (1~3) to obtain the weighed compound Chinese medicine composition.

[0072] S2. Add the weighed traditional Chinese medicine compound composition to 8-12 times its volume of water and soak for 20-40 minutes to obtain the soaked traditional Chinese medicine compound composition.

[0073] S3. Heat and decoct the soaked Chinese herbal compound composition, combine the decoctions, and filter to obtain a decoction of the Chinese herbal compound composition; the heating and decoction is carried out 2 to 3 times, each time for 30 to 45 minutes.

[0074] S4. Concentrate the extract of the decocted and filtered traditional Chinese medicine compound composition to obtain the traditional Chinese medicine compound preparation. In this invention, the extract of the decocted and filtered traditional Chinese medicine compound composition is concentrated under reduced pressure at 60℃ to 80℃, and then freeze-dried in a vacuum freeze dryer. After the powder is completely freeze-dried, it is stored for later use. Through process optimization experiments comparing various drying processes such as atmospheric pressure concentration, reduced pressure concentration, spray drying, and vacuum freeze drying, it was determined that reduced pressure concentration combined with vacuum freeze drying can maximize the preservation of the activity of heat-sensitive components (such as flavonoids, polysaccharides, volatile oils, etc.) in the traditional Chinese medicine compound. Reduced pressure concentration within the range of 60℃ to 80℃ can rapidly evaporate water while ensuring the stability of the main active ingredients, avoiding oxidation or polymerization inactivation of components under high temperature conditions; subsequent vacuum freeze drying can remove the remaining water by sublimation at low temperature, maintaining the microstructure and pharmacological activity of the powder. This parameter selection not only optimizes the concentration and drying efficiency of the extract but also ensures the integrity of the pharmacologically active substances in the compound.

[0075] The proportion range of the traditional Chinese medicine compound composition of this invention is determined based on the recommended dosage range of the Pharmacopoeia of the People's Republic of China and equivalent conversions from animal experiments. To verify the rationality of the proportions, experiments and comparative analyses were conducted on different proportion schemes. The comparative results of the traditional Chinese medicine compound composition based on different proportion schemes are presented in Table 3. The experimental results show that when the proportion of the main medicinal materials (such as Lysimachia christinae, Epimedium, and Lobelia chinensis) is too low (Group A), the inhibitory effect on bladder inflammation and the ability to repair tissue are insufficient; when the proportion is in a moderate range (Group B), the improvement in bladder capacity, leakage point pressure, and urinary inflammation indicators is most significant; when the proportion of some medicinal materials is further increased (Group C), the efficacy is not significantly enhanced, and some experimental animals show a slight decrease in weight. Comprehensive analysis shows that the determined proportion range achieves an optimal balance between efficacy and safety. Furthermore, when it is below the lower limit (Group D), the efficacy is significantly weakened. Furthermore, after removing herbs such as Patrinia scabiosaefolia and Asarum sieboldii (Group E), the overall compound score decreased by 40%, indicating a significant synergistic effect among the herbs described in this invention. In summary, the formulation ratio defined in this invention not only conforms to the reasonable range of pharmacopoeia recommended dosages, but also verifies the optimal balance between efficacy and safety in animal experiments, demonstrating the scientific validity and inventiveness of the stated range.

[0076] Table 3 Comparison of Traditional Chinese Medicine Compound Compositions with Different Formulations

[0077]

[0078] Note: The overall efficacy score is based on a comprehensive evaluation of three indicators: inflammation suppression, tissue repair, and bladder function recovery (maximum score 5 points).

[0079] In summary, the compound formulations within the specified ratio range exhibit significant anti-inflammatory, antioxidant, and tissue repair effects, with group B showing the most significant efficacy. Formulations outside this range show decreased efficacy or safety issues. The defined ratio range is a scientifically sound, reasonable, and innovative technical feature. This invention demonstrates excellent efficacy and safety in the treatment of acute radiation cystitis. Furthermore, the traditional Chinese medicine composition of this invention has good effects in improving symptoms of radiation cystitis, restoring bladder function, and reducing tissue damage, and is highly safe and convenient to use.

[0080] Example 1

[0081] This invention proposes a reverse network pharmacology method for screening traditional Chinese medicine (TCM) compound formulas for the treatment of acute radiation cystitis. This embodiment pertains to the component screening and core target discovery of the TCM compound formulas of this invention, aiming to... The correlation angle system identifies potential pharmacological pathways associated with acute radiation cystitis, providing a scientific basis for subsequent compound formulation and ratio optimization.

[0082] Mainly includes:

[0083] To collect potential targets related to radiation-induced cystitis (RC), this invention employs the following steps: First, by searching relevant disease information in multiple databases, including Genecards, OMIM, DrugBank, and Disgenet, all targets related to RC are screened. After removing duplicates, the intersection targets of RC, radiation injury, and cystitis are obtained. Then, the collected targets are standardized using the Uniprot database to ensure data consistency and accuracy. Finally, key targets representing RC are identified as the basis for subsequent analysis. The intersection targets of RC, radiation injury, and cystitis are imported into the STRING website for PPI network interaction analysis, and then the data is imported into Cytoscape for core target screening.

[0084] This invention screens differentially expressed genes between the blank control group and the radiation cystitis model group in single-cell transcriptome data of rat radiation cystitis, imports the data into the STRING website for PPI network interaction analysis, and then imports the data into Cytoscape software for core target screening.

[0085] This invention screens differentially expressed genes between the blank control group and the radiation cystitis model group in the rat radiation cystitis conventional transcriptome data, imports the data into the STRING website for PPI network interaction analysis, and then imports the data into Cytoscape software for core target screening.

[0086] result:

[0087] Please see Figure 1 This yields the intersection target of radiation cystitis, radiation injury, and cystitis; please refer to [link / reference]. Figure 2 As can be seen, the disease database identified 41 core targets. Please refer to [link / reference needed]. Figure 3 As can be seen, 24 core targets were identified through single-cell transcriptome data screening. Please refer to [link / reference]. Figure 4 It can be seen that a total of 26 core targets were screened out from the ordinary transcriptome data.

[0088] Example 2

[0089] This invention proposes a screening test for compounds corresponding to the disease target of radiation-induced cystitis. This embodiment pertains to the determination of candidate compounds and core components of the traditional Chinese medicine compound of this invention. It mainly utilizes forward network pharmacology analysis to systematically match the disease target obtained in Example 1 with candidate compounds and traditional Chinese medicine, identifying drug combinations highly correlated with the pathological process of radiation-induced cystitis. By verifying the core role and synergistic effect of candidate traditional Chinese medicine in the pharmacological network, the rational composition of the compound is determined. This embodiment does not involve specific dosage or ratio optimization.

[0090] Mainly includes:

[0091] To screen for potentially effective compounds, this invention utilizes the Traditional Chinese Medicine Systems Pharmacology Database (TCMSP) platform to collect compound information related to the target of radiation-induced cystitis. Based on pharmacokinetic parameters and Lipinski's rule, this invention conducts preliminary screening of compounds. The screening criteria are oral bioavailability (OB) ≥ 30%, drug similarity (DL) ≥ 0.18, and drug half-life (…). The time interval is >4h to effectively predict the drug properties and biological activities of compounds. This invention verifies the compounds in the preliminary screening results to ensure they meet actual experimental requirements; by removing duplicates and supplementing relevant active ingredients, candidate compounds are obtained. This invention imports the relationship between candidate compounds and radiation-induced cystitis disease targets into Cytoscape 3.10.1 software for visualization, constructing... The network is used to calculate the topological parameters (such as node degree) of each node in the network to screen out core targets and compounds, which serve as an important basis for subsequent analysis.

[0092] This invention aims to reveal the traditional Chinese medicine components related to the treatment of radiation-induced cystitis. First, the active ingredients corresponding to previously screened compounds were retrieved using the TCMSP database, and the corresponding traditional Chinese medicine information was obtained. Then, the merging function module in Cytoscape 3.10.1 software was used to merge the… "Network and" "Network integration into a complete" "A four-dimensional correlation network. In this four-dimensional correlation network, each node represents a target, compound, or traditional Chinese medicine component, and each edge reflects the interaction or connection between nodes. By calculating the topological parameters of each node, especially the node degree, key drugs and traditional Chinese medicine components occupying core positions in the network are identified. Combining the basic theories of traditional Chinese medicine, the etiology and pathogenesis of radiation cystitis, and clinical symptoms, this invention further evaluates the potential and efficacy of relevant core traditional Chinese medicine components in the treatment of radiation cystitis, providing a basis for subsequent compound design and new drug development."

[0093] This invention, through Cytoscape analysis of Degree values ​​and frequency analysis of traditional Chinese medicine (TCM), further proposes patterns for the use of candidate TCM compositions in the treatment of radiation-induced cystitis. In this process, this invention systematically summarizes the principles of TCM formulation by combining the four natures and five flavors of TCM and their meridian tropism; by analyzing the etiology and pathogenesis of radiation-induced cystitis and its main clinical symptoms, and based on the principles of TCM syndrome differentiation and treatment, a TCM compound composition is obtained.

[0094] This invention performs forward network pharmacology analysis on traditional Chinese medicine compound formulas, and then takes the intersection of the obtained core targets with the core targets in reverse network pharmacology; and takes the intersection of the obtained core compounds with the core compounds in reverse network pharmacology.

[0095] result:

[0096] Please see Figure 5The traditional Chinese medicine compound composition for the treatment of radiation-induced cystitis obtained by this invention includes: Principal herb: Epimedium, which tonifies the kidney and strengthens yang, improves qi transformation function, and works synergistically with Cuscuta to regulate kidney deficiency factors in the pathogenesis; Lysimachia christinae, which clears heat and promotes diuresis, directly targeting the core pathogenesis of radiation-induced cystitis, such as damp-heat accumulation and painful urination. Assistant herbs: Patrinia scabiosaefolia, which clears heat and detoxifies, reduces swelling and dissipates nodules, supplementing the heat-clearing and anti-inflammatory effects, and promoting bladder mucosal repair; Sophora flavescens, which clears heat and dries dampness, has antibacterial and anti-inflammatory effects, targeting symptoms such as frequent urination and painful urination, and strengthening the dampness-removing effect; Scutellaria barbata, which clears heat and detoxifies, invigorates blood and removes blood stasis, enhances anti-inflammatory and anti-fibrotic effects, and prevents the condition from worsening. The assistant herbs work synergistically with the principal herb to further alleviate inflammatory reactions and local damp-heat symptoms, while preventing tissue fibrosis. Adjuvant herbs: Cuscuta chinensis, which tonifies the kidney and strengthens essence, improves the deficiency of kidney qi in the lower jiao of patients with radiation-induced cystitis, and enhances bladder function; Smilax glabra, which clears heat and detoxifies, removes dampness and promotes urination, and works synergistically with Lysimachia christinae to strengthen the heat-clearing, dampness-removing, and detoxifying effects. The main pathogenesis of radiation cystitis is the accumulation of damp-heat and invasion of toxic pathogens. Lysimachia christinae and Smilax glabra directly target the primary pathogen and are the core drugs. Hippophae rhamnoides invigorates blood circulation, removes blood stasis, enhances tissue repair, and improves microcirculation after bladder injury. Erigeron breviscapus: clears the channels, relieves pain, invigorates blood, and removes blood stasis, further enhancing anti-fibrotic and tissue repair effects. The adjuvant drugs focus on tonifying the kidneys, strengthening the body's foundation, invigorating blood, removing blood stasis, clearing the channels, and relieving pain, while also playing a harmonizing role between tonifying deficiency and anti-inflammation. The guiding drug: Glycyrrhiza uralensis, harmonizes the other drugs, reduces gastrointestinal irritation, and simultaneously exerts heat-clearing, detoxifying, and diuretic effects.

[0097] Please see Figure 6 , Figure 7 and Figure 8 The core target intersection revealed 27 overlapping targets, demonstrating the accuracy of the target selection. Eight of the top 13 core compounds were also overlapping, further confirming the accuracy of the target selection. Figure 9 and Figure 10This invention utilizes GO (Gene Ontology) and KEGG (Kyoto Encyclopedia of Genes and Genomes) for functional enrichment analysis. GO-BP (Bioprocess) analysis revealed that the core targets of the compound were primarily enriched in biological processes closely related to the occurrence and development of acute radiation cystitis, including responses to lipopolysaccharide, bacterial-derived molecular responses, regulation of apoptosis signaling pathways, epithelial cell proliferation, responses to changes in oxygen levels, wound healing, hypoxia responses, and oxidative stress responses. KEGG enrichment analysis showed that the core targets were significantly enriched in multiple key signaling pathways, including the PI3K-AKT signaling pathway, HIF-1 signaling pathway, TNF signaling pathway, JAK-STAT signaling pathway, and PD-L1 signaling pathway. These signaling pathways play a crucial role in the occurrence and progression of the disease, specifically in key aspects such as inflammatory responses, oxidative stress, apoptosis, and mucosal repair. In particular, pathways related to oxidative stress and epithelial cell proliferation (such as hypoxia responses and oxidative stress responses) play an important role in acute radiation cystitis. Radiation-induced oxidative stress damage is a major driver of disease, further exacerbating bladder tissue damage by activating redox imbalance and inflammatory responses. Epithelial cell proliferation is closely related to bladder mucosal repair and is regulated by multiple signaling pathways. This invention, through a synergistic effect of multiple mechanisms, encompasses multi-target actions from inflammatory responses, apoptosis signal regulation, oxidative stress relief to epithelial tissue repair, significantly protecting the bladder mucosa, improving the pathological damage of radiation cystitis, and providing a theoretical basis for clinical treatment.

[0098] Example 3

[0099] This invention presents an in vivo animal validation experiment of a traditional Chinese medicine compound composition for acute radiation cystitis.

[0100] Mainly includes:

[0101] This invention used 36 male Sprague-Dawley rats, aged 8 weeks and weighing 260-280g, provided by Sprague (Beijing, China) Biotechnology Co., Ltd. The experimental animals were housed in a designated pathogen-free animal research center and provided with free access to food and water during the experiment.

[0102] The modeling process of this invention mainly involves anesthetizing rats with intraperitoneal injection of 5% sodium pentobarbital (30 mg / kg). Rats in the radiation injury group and drug treatment group were fixed in a supine position and irradiated with a single dose of 25 Gy (3 Gy / min) X-ray in the pelvic cavity using a biological irradiation instrument (PXi X-RAD 320, Precision X-ray, USA) to establish an acute radiation cystitis model. To minimize damage to surrounding normal tissues, a lead plate was used for local shielding. Rats in the normal control group received the same anesthesia as the irradiated group but were not irradiated.

[0103] This invention uses a compound traditional Chinese medicine preparation. The proportions of the compound traditional Chinese medicine composition are as listed in Scheme B in Table 3. The weight proportions of each component are as follows: 3 parts Lysimachia christinae, 2 parts Epimedium, 3 parts Patrinia scabiosaefolia, 3 parts Smilax glabra, 1.8 parts Sophora flavescens, 2 parts Lobelia chinensis, 2.4 parts Cuscuta chinensis, 2 parts Hippophae rhamnoides, 2 parts Asarum sieboldii, and 2 parts Glycyrrhiza uralensis. The specific preparation method is as follows: take 15g of Lysimachia christinae, 10g of Epimedium, 15g of Patrinia scabiosaefolia, 15g of Smilax glabra, 9g of Sophora flavescens, 10g of Lobelia chinensis, 12g of Cuscuta chinensis, 10g of Hippophae rhamnoides, 10g of Asarum sieboldii, and 10g of Glycyrrhiza uralensis. All the traditional Chinese medicine pieces are provided by the pharmacy of the Affiliated Hospital of Changchun University of Traditional Chinese Medicine. The Chinese herbal decoction pieces were soaked in distilled water for 0.5 hours, then decocted three times at a ratio of 1:10, each time at 100℃ for 40 minutes. The three decoctions were combined and concentrated using an evaporator to a final concentration of 2L. This concentrate was then freeze-dried in a vacuum freeze dryer until the powder was completely freeze-dried and stored for later use. Dexamethasone was used as a positive control drug. 100mg of dexamethasone was dissolved in sterile saline to prepare a homogeneous solution. The drug concentration was adjusted according to the conversion ratio between human and rat dosages for subsequent experiments.

[0104] Thirty-six rats were randomly divided into six groups: normal control group (NC, n=6), radiation injury group (RD, n=6), high-dose drug treatment group FDQJD-H (HT, n=6), medium-dose drug treatment group FDQJD-M (MT, n=6), low-dose drug treatment group FDQJD-L (LT, n=6), and dexamethasone group (PC, n=6). The medium-dose group received the normal dose, the low-dose group received 0.5 times the normal dose, and the high-dose group received twice the normal dose. The NC and RD groups were administered an equal volume of purified water by gavage. All rats were treated continuously for 14 days, and their weight was measured daily to calculate the accurate dosage. Bladder tissue appearance, leakage point pressure, and bladder capacity were observed. Urine analysis, pathological staining analysis, transmission electron microscopy analysis, and drug toxicity analysis were performed.

[0105] In this study, a Biopac MP36R multiconductor physiological recorder was used to measure bladder capacity and leakage point pressure. The system's high-precision data acquisition and real-time monitoring capabilities accurately recorded changes in bladder function and physiological data. After successful anesthesia, rats were fixed in a supine position, and a 2cm longitudinal incision was made along the midline above the pubic symphysis to expose the bladder. A pressure sensor was connected to the Biopac MP36R multiconductor physiological recorder and fixed to the bladder surface. After connecting the sensor, the sampling rate was set to 100Hz (preferably 50-200Hz) to ensure real-time, continuous capture of dynamic changes in intrabladder pressure. The sampling rate was determined based on the temporal characteristics of pressure fluctuations during bladder filling and emptying; too low a sampling rate may lead to peak loss, while too high a sampling rate increases noise and data volume. Experiments verified that 100Hz stably recorded the pressure change curve and provided the optimal signal-to-noise ratio. The Biopac system sampling accuracy was set to 16-bit, and the pressure sensor calibration range was 0-200 mmHg. Three measurements were taken from each rat, and the average value was used to reduce individual differences and operational errors. A microinfusion pump was used to slowly inject physiological saline into the bladder via the urethra, and pressure changes within the bladder were monitored using a pressure sensor. The relationship between pressure and injected fluid volume was recorded. As the injection volume gradually increased, changes in bladder pressure and whether urine leaked from the urethral opening were observed; the point of urine leakage was recorded as the maximum bladder capacity. After the bladder capacity test, the bladder was emptied. Half the maximum bladder capacity of physiological saline was injected into the bladder, and then the bladder was manually emptied. The pressure value within the bladder at this point was recorded as the leakage point pressure. All data were acquired in real time using the Biopac system. After the experiment, the rats were euthanized using carbon dioxide, and the bladder tissue was removed and preserved in liquid nitrogen and tissue fixative for subsequent experimental analysis.

[0106] Urine analysis was performed using Dirui urine analysis strips (H11-800), including urobilinogen, bilirubin, ketone bodies, red blood cells, urine specific gravity, ascorbic acid, protein, nitrite, glucose, pH, and white blood cells, to assess the pathological characteristics of radiation cystitis and the effects of drug intervention.

[0107] Among them, hematoxylin-eosin staining and Masson staining were used to assess pathological changes in bladder tissue.

[0108] After 14 days of medication, HE pathological staining was performed on major organs (liver, heart, spleen, lungs, and kidneys) to observe the drug's related toxicity.

[0109] result:

[0110] Please see Figure 11In a study using the traditional Chinese medicine compound of this invention to treat acute cystitis for 14 days, observation of bladder tissue revealed significant improvement in bladder morphology in the FDQJD group. The bladder surface of the radiation-damaged group showed obvious congestion and hemorrhage. In contrast, the bladders of rats treated with FDQJD exhibited a more normal appearance, with significantly reduced bladder wall thickness and fewer congestion and hemorrhage, indicating that FDQJD can alleviate bladder damage and improve its morphology. However, the treatment effect of the dexamethasone group was far worse than that of the FDQJD treatment group. (See also...) Figure 12 Bladder leak point pressure testing showed that the detrusor muscle pressure in the radiation-damaged rats was significantly reduced, indicating impaired bladder function. However, in the FDQJD treatment group, the bladder leak point pressure gradually recovered to near-normal levels, especially in the high-dose (HT) group, where the recovery was most significant. This demonstrates that FDQJD can effectively regulate the tension of the bladder detrusor muscle and alleviate bladder dysfunction caused by radiation cystitis. Please refer to... Figure 13 Radiation cystitis typically leads to decreased bladder capacity, impairing its urinary storage function. Bladder capacity measurements showed a significant decrease in bladder capacity in the radiation injury group, while the FDQJD treatment group exhibited a significant increase in bladder capacity, particularly in the medium- and high-dose groups (MT and HT), where bladder capacity recovered to near the level of the normal control group. This demonstrates the significant efficacy of FDQJD in alleviating bladder insufficiency and restoring bladder function. Please refer to [link to relevant documentation]. Figure 14 Analysis of rat urine showed that FDQJD intervention had a significant effect. In the radiation injury group, the levels of protein, red blood cells, and nitrite in the urine were significantly elevated, reflecting bladder inflammation and damage. However, in the FDQJD treatment group, especially the high-dose group, urine analysis showed a significant decrease in these indicators, indicating that FDQJD can effectively reduce the level of inflammation in the bladder and alleviate damage. Please refer to [link to relevant documentation]. Figure 15Hematoxylin-eosin staining results showed that the bladder structure in the control group was normal, with tightly packed epithelial cells, no obvious degeneration or shedding, a dense lamina propria structure, numerous folds, and abundant collagen fiber content. In the radiation-damaged group, the bladder structure was severely abnormal, with extensive epithelial cell erosion and shedding, disappearance of folds, exposure of the lamina propria, edema of the lamina propria, loose tissue structure, increased interstitial spaces, and reduced collagen fiber content. The damage severity in the low, medium, and high-dose groups was improved compared to the model group. Compared to the model group, the bladder tissue damage severity in the low-, medium-, and high-dose combination groups was reduced, manifested as restoration of mucosal structure, reduced inflammatory cell infiltration, and decreased fibrosis. The fold structure disappeared, some epithelial cells eroded and sloughed off, the lamina propria was edematous, and blood vessels were dilated and congested. The damage severity in the medium-dose group was further reduced, the epithelium was relatively intact, the lamina propria structure was dense, and some blood vessels were mildly dilated and congested. The high-dose group showed the best intervention effect, with intact epithelium, dense lamina propria, and mild blood vessel congestion. The dexamethasone treatment group showed slight improvement, but the effect was worse than the low-dose group. Based on the above experimental results, FDQJD showed significant effects in alleviating the pathological damage of radiation-induced cystitis and improving bladder function, effectively reducing radiation-induced bladder damage and promoting bladder repair and functional recovery. Please refer to [link to relevant documentation]. Figure 16 Under transmission electron microscopy, the normal group Figure 16 In (a) the cell structure is dense, with a large number of mitochondria of uniform size, clear mitochondrial cristae, and intact membranes, as shown by the black arrows; no dilation of the endoplasmic reticulum is observed, as shown by the green arrows; Model group Figure 16 In (b) the cell structure is loose, with numerous electron-transparent regions visible, as indicated by the blue arrows; the endoplasmic reticulum is severely dilated, forming vacuoles, as indicated by the green arrows; the number of mitochondria is reduced, the remaining mitochondria are atrophied, the mitochondrial cristae structure is unclear, and the membrane is ruptured, as indicated by the black arrows; simultaneously, numerous lysosomes are visible, as indicated by the red arrows; (drug-treated group) Figure 16 (c) The damage in this group was less severe than in the model group, with a denser tissue structure, clearly defined mitochondrial cristae, and intact membranes, as shown by the black arrows; the endoplasmic reticulum showed slight dilation, as shown by the green arrows. Please refer to [link to relevant documentation]. Figure 17 HE staining was performed on the major organs (liver, heart, spleen, lungs, and kidneys). The results showed that the tissue structures of all major organs remained intact, with no obvious inflammatory infiltration, necrosis, or pathological changes, indicating that the herbal compound of this invention did not cause significant systemic toxicity or organ damage. Toxicity analysis showed that the herbal compound of this invention is safe for the treatment of acute radiation cystitis, with no toxic side effects and no damage to major organs.

[0111] Example 4

[0112] This invention proposes a medium-dose compound for the observation of efficacy in rats with acute radiation cystitis. In this embodiment, the proportion of the traditional Chinese medicine compound composition adopts the scheme B listed in Table 3. The weight proportions of each component are as follows: 3 parts of Lysimachia christinae, 2 parts of Epimedium, 3 parts of Patrinia scabiosaefolia, 3 parts of Smilax glabra, 1.8 parts of Sophora flavescens, 2 parts of Lobelia chinensis, 2.4 parts of Cuscuta chinensis, 2 parts of Hippophae rhamnoides, 2 parts of Erigeron breviscapus, and 2 parts of Glycyrrhiza uralensis. The specific dosage of the drugs is as follows: take 15g of Lysimachia christinae, 10g of Epimedium, 15g of Patrinia scabiosaefolia, 15g of Smilax glabra, 9g of Sophora flavescens, 10g of Lobelia chinensis, 12g of Cuscuta chinensis, 10g of Hippophae rhamnoides, 10g of Erigeron breviscapus, and 10g of Glycyrrhiza uralensis.

[0113] Mainly includes:

[0114] The therapeutic effect of medium-dose compound on rats with acute radiation cystitis was observed to verify its ability to improve function, relieve inflammation and repair tissue.

[0115] An acute radiation cystitis model was established using male SD rats and pelvic irradiation with 25 Gy.

[0116] Model establishment included: 8-week-old male SD rats (260-280g, n=36) were selected, housed in an SPF environment with free access to food and water, and acclimatized for 14 days. Rats were anesthetized by intraperitoneal injection of 5% sodium pentobarbital (30mg / kg) and fixed in a supine position on the irradiation table. A PXi X-RAD320 biological irradiator (Precision X-Ray, USA) was used, with a single pelvic irradiation of 25Gy at a dose rate of 3Gy / min, a focal-to-skin distance of 50cm, and a total irradiation time of 8.3min. To reduce non-target area damage, a 3mm lead plate was used to shield the non-pelvic areas of the abdominal cavity and limbs, exposing only the pelvic irradiation field from the pubic symphysis to the tail root (approximately 3×4cm, confirmed by surface localization). The normal control group received the same anesthesia and fixation but no irradiation; other model-related treatments were consistent. The day of model establishment was recorded as D0, and the acute phase assessment window was D3-D14; drug administration began on D1 and continued for 14 days according to the grouping protocol. Model success determination (final determination on D14): Urinalysis: Elevated levels of dry chemical strip 3 (red blood cells / white blood cells / protein) Urinalysis or microscopic examination showing >50 red blood cells / HP; Functional (either): bladder capacity decreased by ≥30% compared to control, or leakage point pressure (LPP) decreased by ≥20%; Histological: HE examination showed mucosal epithelial shedding, congestion, edema, and inflammatory infiltration; Masson's test showed increased early collagen deposition; Successful modeling was determined by meeting urological criteria plus (functional or histological) criteria. Those not meeting the criteria were excluded or analyzed separately.

[0117] After successful model establishment, the compound medium-dose group (3g / kg) was administered by gavage for 14 consecutive days. Functional, urinary, biochemical, and histological parameters were compared among the normal control group (NC), the model group (RD), and the medium-dose treatment group (MT).

[0118] result:

[0119] The test indicators and results showed that bladder capacity was measured 14 days after the application of the compound of this invention: the model group showed a significant decrease, while the medium-dose treatment group showed a significant improvement compared to the model group. Figure 18 As shown; Leakage point pressure: significantly higher in the MT group than in the RD group, such as Figure 19 As shown; urine analysis: protein, red blood cells, and white blood cells are all decreased, as shown. Figure 20 As shown; HE and Masson staining: bladder mucosal damage was well repaired, and collagen deposition was reduced, as shown. Figure 21 As shown, the medium-dose compound preparation significantly improved bladder function and pathological condition in rats with acute radiation cystitis, demonstrating good therapeutic efficacy.

[0120] Example 5

[0121] This invention presents a comparative experiment on the effects of different dosages of a compound preparation on radiation-induced cystitis. In this embodiment, the proportions of the traditional Chinese medicine compound preparation are as listed in Scheme B in Table 3. The weight proportions of each component are as follows: 3 parts of Lysimachia christinae, 2 parts of Epimedium brevicornu, 3 parts of Patrinia scabiosaefolia, 3 parts of Smilax glabra, 1.8 parts of Sophora flavescens, 2 parts of Lobelia chinensis, 2.4 parts of Cuscuta chinensis, 2 parts of Hippophae rhamnoides, 2 parts of Erigeron breviscapus, and 2 parts of Glycyrrhiza uralensis. The specific dosages of the drugs are as follows: take 15g of Lysimachia christinae, 10g of Epimedium brevicornu, 15g of Patrinia scabiosaefolia, 15g of Smilax glabra, 9g of Sophora flavescens, 10g of Lobelia chinensis, 12g of Cuscuta chinensis, 10g of Hippophae rhamnoides, 10g of Erigeron breviscapus, and 10g of Glycyrrhiza uralensis.

[0122] Mainly includes:

[0123] This study investigates the dose-response relationship of traditional Chinese medicine compound prescriptions to clarify the differences in efficacy of different doses for radiation-induced cystitis.

[0124] The same acute radiation cystitis model was established, using the same modeling method as in Example 4.

[0125] After successful model establishment, rats were divided into three treatment groups: low-dose (1.5 g / kg), medium-dose (3 g / kg), and high-dose (6 g / kg). Rats were administered the treatment by gavage once daily for 14 consecutive days. Differences in functional and pathological indicators among the three groups were compared.

[0126] result:

[0127] The results showed that with increasing dosage, bladder capacity and leakage point pressure significantly improved, exhibiting a clear dose-dependent trend. Figure 22, 23 As shown in the figure. Regarding urinary inflammatory markers, the high-dose group (HT) showed more significant improvement in red blood cell and protein levels compared to the low-dose group (LT) and the medium-dose group (MT). Figure 24 As shown in the figure. HE and Masson staining results showed that the mucosal structure in the high-dose group was basically restored to its original state, and the infiltration of inflammatory cells was significantly reduced, with better results than the low- and medium-dose groups. Figure 25 As shown above, the results indicate that the traditional Chinese medicine compound of this invention has a clear dose-dependent effect in the acute radiation cystitis model, with 3–6 g / kg being the optimal dose range.

[0128] Example 6

[0129] This invention presents a comparative study of the efficacy of a compound preparation and dexamethasone in the treatment of acute radiation cystitis. In this embodiment, the proportions of the traditional Chinese medicine compound preparation are as listed in Scheme B in Table 3. The weight proportions of each component are as follows: 3 parts Lysimachia christinae, 2 parts Epimedium, 3 parts Patrinia scabiosaefolia, 3 parts Smilax glabra, 1.8 parts Sophora flavescens, 2 parts Lobelia chinensis, 2.4 parts Cuscuta chinensis, 2 parts Hippophae rhamnoides, 2 parts Asarum heterotropoides, and 2 parts Glycyrrhiza uralensis. The specific dosages of the drugs are as follows: take 15g of Lysimachia christinae, 10g of Epimedium, 15g of Patrinia scabiosaefolia, 15g of Smilax glabra, 9g of Sophora flavescens, 10g of Lobelia chinensis, 12g of Cuscuta chinensis, 10g of Hippophae rhamnoides, 10g of Asarum heterotropoides, and 10g of Glycyrrhiza uralensis.

[0130] Mainly includes:

[0131] The effects of the traditional Chinese medicine compound prepared in this invention and the classic anti-inflammatory drug dexamethasone were compared to evaluate its superior efficacy. After rat modeling, rats were treated with a medium dose of the compound (3 g / kg) and dexamethasone (0.03 mg / kg) for 14 days. The functional, urinary, and histopathological manifestations of the two groups were evaluated. Specific experimental conditions included:

[0132] Functional assessment (bladder capacity and leakage point pressure, LPP): After anesthetizing rats, the bladder was exposed by a midline incision, and a catheter was inserted and fixed. A Biopac MP36R multichannel physiological recording system was used; the pressure transducer range was 0–200 mmHg, 16-bit; the sampling rate was 100 Hz (50–200 Hz optional). A microinfusion pump was used to continuously inject physiological saline (sterile 0.9% NaCl, room temperature) at a constant flow rate of 0.10 mL / min (0.05–0.20 mL / min optional), and the pressure-volume curve was recorded in real time. The injection volume at which urine first overflows from the urethra was defined as the maximum bladder capacity. After emptying the bladder, 50% of this maximum capacity of physiological saline was injected, and the intravesical pressure at this time was recorded and defined as the leakage point pressure (LPP). Measurements were repeated three times per rat, and the mean value was used. The device was calibrated with known pressures before and after use.

[0133] Urinalysis included collecting fresh urine in a metabolic cage for 2 hours at the endpoint (D14); gentle bladder tapping was used to assist urination if necessary. The urine was centrifuged at 3000 rpm for 10 minutes, and the supernatant was used for dry chemistry strips; the precipitate was examined microscopically. The urinalysis was performed using the Dirui H11-800 dry chemistry test strip, and the following parameters were read according to the instructions: urobilinogen, bilirubin, ketone bodies, red blood cells, specific gravity, ascorbic acid, protein, nitrite, glucose, pH, and white blood cells (semi-quantitative 0, ±, ...). RBC / WBC counts were performed per high-power field (HPF) using a microscope, and the average value was taken from 10 fields. A protein level >50 / HPF is considered positive for hematuria; This is considered a positive result for proteinuria.

[0134] Histopathological (HE / Masson) analysis included immediate removal of the bladder fornix and body from euthanized rats, followed by fixation in 10% neutral formalin for 24 hours. Routine dehydration and paraffin embedding were performed; sections were 4 μm thick. Staining: HE was used to assess epithelial shedding, congestion and edema, and inflammatory infiltration using standard procedures; Masson staining was used to assess collagen deposition and fibrosis. Normality was determined by Shapiro–Wilk, and homogeneity of variance was determined by Levene. Independent samples t-tests were used for comparisons between two groups, and one-way ANOVA with Tukey analysis was used for comparisons between multiple groups. The significance threshold was P < 0.05.

[0135] result:

[0136] This invention can stably capture the pressure peak during filling / expelling at 100Hz, and the 0.10mL / min flow rate balances physiological stability and curve smoothness; determining LPP at 50% volume reduces volume-dependent bias and improves inter-group comparability. Standardizing the urine collection window and centrifugation conditions reduces batch-to-batch variability; dry chemistry and microscopic examination provide mutual verification, improving sensitivity and specificity. Standardizing the fixative and section thickness ensures staining consistency; the use of a scale and blinding method improves objectivity and reproducibility.

[0137] This invention systematically evaluated the efficacy and safety of a traditional Chinese medicine compound preparation combined with dexamethasone in the treatment of acute radiation cystitis by establishing a rat model of acute radiation cystitis. Compared with the model group, the compound preparation group significantly improved bladder dysfunction, as evidenced by a significant increase in bladder capacity and a marked increase in leakage point pressure (LPP). Figure 26 , Figure 27 Compared with the dexamethasone group, the compound group showed a greater increase in bladder capacity and LPP, suggesting a superior effect in restoring bladder compliance and sphincter function. Urinalysis results showed ( Figure 28The levels of red blood cells and white blood cells in the compound drug group were significantly lower than those in the model group, and further decreased compared to the dexamethasone group, indicating that the compound drug of this invention is more effective in reducing bleeding and inhibiting radiation-induced inflammatory responses. Histological observation showed that HE staining results indicated (…). Figure 29 The compound medication group showed intact bladder mucosal epithelial structure, significant regeneration, and a marked reduction in inflammatory cell infiltration, demonstrating a superior degree of repair compared to the dexamethasone group. Masson staining further confirmed that the compound group exhibited less collagen deposition and a significantly lower degree of fibrosis compared to the dexamethasone group, suggesting a clear advantage in preventing bladder tissue fibrosis. Comprehensive analysis indicates that the traditional Chinese medicine compound of this invention is superior to the dexamethasone group in improving bladder function, reducing inflammatory responses, promoting epithelial repair, and inhibiting tissue fibrosis, with no significant toxic reactions and higher safety, demonstrating good therapeutic potential and clinical application value.

[0138] Mechanism studies of this invention demonstrate that the compound traditional Chinese medicine exerts a synergistic effect of anti-inflammation, anti-oxidation, and tissue repair promotion by regulating MAPK, PI3K-AKT, and NF-κB signaling pathways through multiple components and targets. Unlike the single-target immunosuppressive mechanism of traditional glucocorticoids (such as dexamethasone), the compound of this invention possesses multiple effects including "clearing heat and detoxifying, promoting diuresis and relieving strangury, activating blood circulation and removing blood stasis, and repairing mucosa," which can improve the microenvironment of bladder tissue as a whole and promote epithelial cell regeneration and functional recovery. In summary, the compound traditional Chinese medicine of this invention is superior to other existing technologies in improving the symptoms of acute radiation cystitis, promoting tissue repair, and enhancing bladder function, and has the characteristics of high safety, significant efficacy, and compatibility with modern drugs.

[0139] Example 7

[0140] This invention proposes an effect of different dosing cycles on the efficacy of a compound preparation for acute radiation cystitis. In this embodiment, the proportions of the traditional Chinese medicine compound preparation are as listed in Scheme B in Table 3. The weight proportions of each component are as follows: 3 parts Lysimachia christinae, 2 parts Epimedium, 3 parts Patrinia scabiosaefolia, 3 parts Smilax glabra, 1.8 parts Sophora flavescens, 2 parts Lobelia chinensis, 2.4 parts Cuscuta chinensis, 2 parts Hippophae rhamnoides, 2 parts Asarum sieboldii, and 2 parts Glycyrrhiza uralensis. The specific dosages of the drugs are as follows: take 15g of Lysimachia christinae, 10g of Epimedium, 15g of Patrinia scabiosaefolia, 15g of Smilax glabra, 9g of Sophora flavescens, 10g of Lobelia chinensis, 12g of Cuscuta chinensis, 10g of Hippophae rhamnoides, 10g of Asarum sieboldii, and 10g of Glycyrrhiza uralensis.

[0141] Mainly includes:

[0142] By comparing the therapeutic effects of the traditional Chinese medicine compound proposed in this invention on rats with acute radiation cystitis after continuous administration for 7 days and 14 days at the same dosage, the influence of the administration period on the efficacy was clarified.

[0143] After successful modeling in male SD rats, they were randomly divided into two groups. Both groups received a medium dose (3g / kg) of the compound treatment via gavage for 7 days (MT-7d) and 14 days (MT-14d), respectively. Differences between the two groups in urinary inflammatory markers, bladder tissue repair, and functional indicators were compared. Specifically, these included:

[0144] Eight-week-old male Sprague-Dawley rats (weighing 260–280 g) were selected to establish an acute radiation cystitis model under the same conditions (single pelvic irradiation of 25 Gy, dose rate 3 Gy / min). After successful modeling, the rats were randomly divided into two groups of nine each, both receiving a medium dose (3 g / kg) of the compound drug via gavage. The group was designated as the MT-7d group (7 consecutive days of administration) and the MT-14d group (14 consecutive days of administration). A normal control group and a model control group were established concurrently, receiving an equal volume of purified water. The compound drug was stored as a lyophilized powder and dissolved in purified water before use. The gavage volume was 10 mL / kg, once daily. The dosage was calculated based on human equivalence to ensure a stable drug concentration without adverse reactions. Histopathological examination involved tissue samples from the bladder fornix, fixed in 10% neutral formalin for 24 hours, routinely embedded in paraffin, sectioned (4 μm), and stained with hematoxylin and eosin (HE) and Masson staining. HE staining was used to observe epithelial integrity and inflammatory cell infiltration, while Masson staining was used to assess the degree of fibrosis. The assessments were performed blinded by two pathologists. Bladder function parameters were evaluated using a Biopac MP36R multichannel physiological recording system to measure bladder capacity at a sampling rate of 100 Hz and an injection flow rate of 0.10 mL / min. Measurements were taken three times per animal, and the average value was used.

[0145] result:

[0146] This invention combines the pathological progression of acute radiation cystitis, which enters the repair phase in about 7 to 14 days, to determine the comparative window for short-term and medium-term interventions.

[0147] The results showed that both groups improved bladder function and urinary inflammatory response, with the MT-14d group exhibiting more significant efficacy. Bladder capacity: The bladder capacity of the MT-14d group was significantly higher than that of the MT-7d group (e.g., ...). Figure 30 As shown in the figure), the values ​​are close to normal, indicating a more complete recovery of bladder contraction function; no obvious toxic side effects or abnormal deaths were observed throughout the experiment. HE and Masson staining results showed that the MT-14d group had complete bladder epithelial regeneration, reduced inflammatory cell infiltration, and less collagen deposition; the MT-7d group still showed some mucosal edema and inflammatory cell infiltration (such as...). Figure 31(As shown). This indicates that, at the same dosage, extending the dosing cycle of the compound preparation can further enhance the therapeutic effect; continuous administration of MT-14d is significantly superior to MT-7d in reducing bladder inflammation, repairing bladder mucosa, and restoring function, suggesting that a longer course of treatment is more suitable for traditional Chinese medicine intervention strategies for clinical radiation cystitis. The compound preparation of this invention has good time dependence and cumulative efficacy; compared with dexamethasone, the compound preparation of this invention has no obvious toxicity with long-term administration, has high safety, and is suitable for continuous repair treatment of patients after radiotherapy.

[0148] Example 8

[0149] This invention presents an application example of a traditional Chinese medicine preparation for acute radiation cystitis.

[0150] Mainly includes:

[0151] The standard dosage of this invention is a daily compound for adults: "one dose per day, divided into 2-3 oral administrations".

[0152] Total amount of raw medicinal materials in compound preparation: preferably about 116g / dose, with a process fluctuation of 100~200g / dose allowed.

[0153] The yield of the extract—lyophilized dry extract—is 15%–25%, preferably 18%–22%. Based on this, the daily equivalent dry extract is approximately 20–25g for 116g of raw herb. Treatment duration: 28 days is recommended for the acute phase, and may be extended to 42 days if necessary, based on improvement in symptoms and objective indicators.

[0154] Formulation conversion and quality consistency verification:

[0155] This invention first performs mass spectrometry (LC-MS) analysis on the lyophilized powder of the compound preparation. The results show that the drying and lyophilization processes did not destroy the structure of the main active ingredients, and the signal peaks of key substances such as icariin, matrine, and scutellarin were completely preserved. The fingerprint spectrum showed a similarity of >0.95 with the compound preparation sample (e.g., ...). Figure 32 (As shown). The granules and tablets subsequently prepared in this invention all use this dry extract powder as an intermediate, and are prepared through conventional processes such as physical mixing, dissolution, granulation, and coating. Therefore, they are equivalent to the compound preparation in terms of composition, differing only in excipients and administration methods. To meet different clinical needs, this invention designs various formulations based on the physicochemical properties of the main pharmacodynamic substances in the dry extract (such as the easy oxidation of flavonoids, poor solubility of saponins, and strong stability of matrine) to improve the stability and absorption efficiency of the compound:

[0156] 1) Granules (to be taken with water)

[0157] Formula and specifications: Granulated from dry extract powder, each bag contains 8g (containing 8g of equivalent dry extract, with excipients such as dextrin / low-substituted hydroxypropyl cellulose in appropriate amounts).

[0158] Dosage and administration (adults): 1 sachet each time, 3 times a day; or 1.5 sachets each time, 2 times a day. The total daily dose is 24g of dry extract, equivalent to a daily compound, taken with 150–200mL of warm water.

[0159] 2) Tablets / film-coated tablets (sustained release optional)

[0160] Prescription and Specifications: Each tablet contains 1.5~2.0g of dry extract; excipients include crospovidone, microcrystalline cellulose, starch, etc. Sustained-release formulation uses HPMC / EC for controlled release, achieving 80%±10% release in vitro within 12 hours. Dosage and Administration (Adults): Immediate-release tablets: 3~6 tablets three times daily; Sustained-release tablets: 3~4 tablets twice daily, with a total daily equivalent of 24g of dry extract.

[0161] The above preparations are administered in small, frequent doses, three times daily, to maintain stable exposure. The course of treatment is 28 days during the acute phase. After improvement of symptoms and objective indicators (urine / function / pathology), the dosage can be reduced or granules can be used for maintenance for 1-2 weeks. It can be used in combination with short-term hyperbaric oxygen therapy, dexamethasone, etc., to quickly control inflammation. This compound reduces the risk of hormone exposure and adverse reactions through repair / protection.

[0162] For children, the dosage is calculated using Clark's formula (based on weight) based on body weight or body surface area: Child's dosage ≈ Adult's dosage × weight (kg) / 70. For children under 12 years old, granules / oral liquid should be used first, with dosage reduced as directed by a physician. Observe for 48-72 hours if no adverse reactions occur before adjusting the dosage.

[0163] The above dosage forms are determined based on the conversion of "one-day compound preparation - 116g of raw herb - 17~29g of dry extract equivalent" to determine the specifications and administration method; through prescription process verification, granules and compound preparations are comparable in terms of fingerprint spectrum and content of main active ingredients.

[0164] result:

[0165] 1) Granules

[0166] Convenient to take, with stable taste and dissolution, and better patient compliance than compound preparations; the bagged dosage reduces batch-to-batch variability.

[0167] 2) Tablets / film-coated tablets (sustained release optional)

[0168] Precise dosage and batch-to-batch uniformity; sustained-release formulation stabilizes blood drug exposure and reduces peak concentration-related discomfort.

[0169] A multi-dosage strategy can significantly improve compliance and dosage accuracy, while maintaining the same efficacy as combination formulations, improving taste, portability and quality consistency, which is beneficial for industrialization and multi-center clinical promotion.

[0170] Comparative Example

[0171] This invention presents a comparative experiment of the compound described herein with other drugs used for acute radiation cystitis.

[0172] Mainly includes:

[0173] To verify the efficacy of the compound of the present invention in the treatment of acute radiation cystitis, a parallel comparative study was conducted between the compound of the present invention and commonly used clinical drugs. The experimental conditions are as follows:

[0174] Eight-week-old male SD rats (260-280g) were selected and an acute radiation cystitis model was established by a single 25Gy pelvic irradiation (dose rate 3Gy / min). After successful modeling, the rats were randomly divided into groups (n=9 per group). The experimental groups were as follows: Group A (normal control group): no irradiation, no medication; Group B (model control group): gavage with the same volume of purified water; Group C (compound group of this invention): administered a medium dose of the compound (3g / kg) once daily by gavage for 14 consecutive days; Group D (dexamethasone group, control group): administered dexamethasone solution (0.03mg / kg) once daily by gavage for 14 consecutive days. All animals were treated under the same feeding conditions, and irradiation, gavage, and testing were all performed by blinded operators. Fourteen days later, urine indicators were tested using a urine analyzer and dry chemical test strips to detect red blood cells, white blood cells, and protein. Functional indicators were measured using a Biopac MP36R system to detect bladder capacity and leakage point pressure (sampling rate 100Hz, flow rate 0.1mL / min, 3 measurements per animal and average value). Histological indicators were observed using HE and Masson staining to assess the degree of bladder epithelial repair and fibrosis.

[0175] result:

[0176] Please refer to Table 4. The compound formulation of this invention (Group C) showed the most significant decrease in urinary red blood cell and white blood cell levels (P<0.05), indicating a marked reduction in inflammatory response. Functionally, bladder capacity and leakage point pressure were significantly higher in the compound formulation group than in the dexamethasone group (Group D). Histologically, the compound formulation group exhibited intact bladder epithelial structure, less inflammatory cell infiltration, and good basement membrane continuity, while the dexamethasone group, although showing some repair, did not demonstrate as much epithelial regeneration as the compound formulation group. Regarding safety, some animals in the dexamethasone group experienced side effects such as weight loss and rough fur, while no significant toxic side effects were observed in the compound formulation group. Dexamethasone was chosen as the control drug because it is a commonly used drug for acute radiation cystitis in clinical practice, but it has significant side effects and limitations on long-term use. This compound formulation, while maintaining high safety, simultaneously achieves anti-inflammatory, antioxidant, and tissue repair effects, superior to single-target hormones or conventional traditional Chinese medicines. Experimental results show that this invention has comprehensive advantages such as multi-target regulation, low toxicity, and high repair capacity.

[0177] Table 4 Comparison of Traditional Chinese Medicine Compound Compositions with Different Formulations

[0178]

[0179] In summary, the compound formulation of this invention outperformed the dexamethasone group in multiple indicators, including bladder capacity, leakage point pressure, inflammation relief, and tissue repair (P<0.05), demonstrating a comprehensive functional recovery effect. The dual anti-inflammatory and repair mechanism not only significantly reduced urinary inflammatory markers but also promoted epithelial regeneration and reduced fibrosis, showcasing the synergistic multi-target advantage of anti-inflammatory and repair mechanisms. Furthermore, this invention exhibits high safety, with no significant toxic side effects after long-term administration, and stable weight gain in animals, indicating excellent drug safety and tolerability. These combined advantages demonstrate that the traditional Chinese medicine compound formulation of this invention is superior to existing treatment regimens in terms of functional recovery, tissue repair, and safety, providing a more efficient and safer alternative treatment route for acute radiation cystitis.

[0180] The present invention has been described in detail above with reference to specific embodiments, but the scope of protection of the present invention is not limited thereto. Those skilled in the art should understand that various modifications and substitutions can be made to the above-described formulation, excipient types, ratios, and preparation processes without departing from the principles and spirit of the present invention.

[0181] Specifically, the traditional Chinese medicine compound composition described in this invention is also applicable to the preparation of various other drug dosage forms, including but not limited to: tablets, capsules, granules, powders, mixtures, injections (such as solution type and lyophilized powder type), inhalers (including aerosols, sprays, and dry powder inhalers), transdermal patches, ointments, creams, suppositories, etc.

[0182] For different dosage forms, conventional excipients known in the art can be selected accordingly, such as: diluents (e.g., starch, microcrystalline cellulose), binders (e.g., hydroxypropyl methylcellulose), disintegrants (e.g., croscarmellose sodium), lubricants (e.g., magnesium stearate), flow aids, coating materials, solvents (e.g., water for injection, oily solvents), surfactants, preservatives, flavoring agents, transdermal absorption enhancers, etc. The preparation of these different dosage forms can all be achieved using conventional techniques in the art (e.g., pulverization, mixing, granulation, tableting, filling, lyophilization, aseptic filtration, etc.), with the aim of providing the traditional Chinese medicine compound composition described in this invention to patients in an effective and stable form.

[0183] It should be noted that the term "comprising," or any other variation thereof, is intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0184] The above are merely embodiments of this application and are not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A traditional Chinese medicine compound composition for treating acute radiation cystitis, characterized in that, The traditional Chinese medicine compound composition, calculated by weight, is prepared by extraction of 2-4 parts of Lysimachia christinae, 1-3 parts of Epimedium, 2-4 parts of Patrinia scabiosaefolia, 2-4 parts of Smilax glabra, 0.8-2.8 parts of Sophora flavescens, 1-3 parts of Lobelia chinensis, 1.4-3.4 parts of Cuscuta chinensis, 1-3 parts of Hippophae rhamnoides, 1-3 parts of Asarum sieboldii, and 1-3 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine compound composition for treating acute radiation cystitis according to claim 1, characterized in that, The traditional Chinese medicine compound composition, calculated by weight, is prepared by extraction of 2.5-3.5 parts of Lysimachia christinae, 1.5-2.5 parts of Epimedium, 2.5-3.5 parts of Patrinia scabiosaefolia, 2.5-3.5 parts of Smilax glabra, 1.3-2.3 parts of Sophora flavescens, 1.5-2.5 parts of Lobelia chinensis, 1.9-2.9 parts of Cuscuta chinensis, 1.5-2.5 parts of Hippophae rhamnoides, 1.5-2.5 parts of Erigeron breviscapus, and 1.5-2.5 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine compound composition for treating acute radiation cystitis according to claim 1, characterized in that, The traditional Chinese medicine compound composition, calculated by weight, is prepared by extraction of 3 parts of Lysimachia christinae, 2 parts of Epimedium, 3 parts of Patrinia scabiosaefolia, 3 parts of Smilax glabra, 1.8 parts of Sophora flavescens, 2 parts of Lobelia chinensis, 2.4 parts of Cuscuta chinensis, 2 parts of Hippophae rhamnoides, 2 parts of Asarum heterotropoides, and 2 parts of Glycyrrhiza uralensis.

4. A traditional Chinese medicine compound preparation for treating acute radiation cystitis, characterized in that, The traditional Chinese medicine compound preparation is composed of the traditional Chinese medicine compound composition for treating acute radiation cystitis as described in any one of claims 1 to 3 and pharmaceutical excipients.

5. The traditional Chinese medicine compound preparation for treating acute radiation cystitis according to claim 4, characterized in that, The traditional Chinese medicine compound preparations include oral solutions, tablets, and granules.

6. The traditional Chinese medicine compound preparation for treating acute radiation cystitis according to claim 4, characterized in that, The pharmaceutical excipients are pharmaceutically acceptable.

7. A method for preparing a traditional Chinese medicine compound preparation for treating acute radiation cystitis according to any one of claims 4 to 6, characterized in that, include: S1. Mix according to the following weight ratio: The following ingredients were weighed: Lysimachia christinae, Epimedium, Patrinia scabiosaefolia, Smilax glabra, Sophora flavescens, Lobelia chinensis, Cuscuta chinensis, Hippophae rhamnoides, Asarum heterotropoides, Glycyrrhiza uralensis = (2~4): (1~3): (2~4): (2~4): (0.8~2.8): (1~3): (1.4~3.4): (1~3): (1~3): (1~3) to obtain the weighed compound Chinese medicine composition; S2. Add the weighed traditional Chinese medicine compound composition to 8-12 times its volume of water and soak for 20-40 minutes to obtain the soaked traditional Chinese medicine compound composition. S3. Heat and decoct the soaked Chinese herbal compound composition, combine the decoctions, and filter to obtain a decoction and filtered Chinese herbal compound composition extract. S4. The extract of the traditional Chinese medicine compound composition after decoction and filtration is concentrated, and then processed into a formulation, quality controlled, packaged and sterilized to obtain the traditional Chinese medicine compound preparation.

8. The method for preparing the traditional Chinese medicine compound preparation for treating acute radiation cystitis according to claim 7, characterized in that, The heating and simmering process is repeated 2 to 3 times.

9. The method for preparing the traditional Chinese medicine compound preparation for treating acute radiation cystitis according to claim 7, characterized in that, Each heating and simmering process takes 30-45 minutes.

10. The use of a traditional Chinese medicine compound preparation for treating acute radiation cystitis prepared by any one of claims 4 to 6 or any one of claims 7 to 9 in the preparation of a drug for treating acute radiation cystitis.

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