Traditional Chinese medicine compound composition with effect of preventing and treating radioactive injury as well as preparation method and application of traditional Chinese medicine compound composition

Abstract

The invention discloses a traditional Chinese medicine compound composition with an effect of preventing and treating radioactive injury as well as a preparation method and application thereof. The traditional Chinese medicine compound composition is prepared from 5-15 parts of American ginseng, 3-6 parts of sea-buckthorn and 10-30 parts of rhizoma polygonati. The composition is proportioned and optimized according to the theory of treatment based on syndrome differentiation, and the medicines are combined to achieve the effects of tonifying qi, activating blood and nourishing yin. Clinical experiment results show that the traditional Chinese medicine compound composition provided by the invention has a remarkable effect of preventing and treating radioactive injury, particularly has a remarkable curative effect in the aspects of improving oral mucositis, dry mouth, weakness, sleep disorder and the like after radiotherapy, and is safe in clinical medication.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine compound, specifically a traditional Chinese medicine compound composition for preventing and treating radiation damage. The invention also discloses its preparation method and medical uses. Background Technology

[0002] Radiotherapy, as a radical treatment for malignant tumors, benefits the vast majority of patients, whether used alone in the early stages or in combination with surgery or chemotherapy in later stages. Although we have entered the era of precision radiotherapy, it is still impossible to avoid temporary or permanent changes in normal tissues within the radiation zone. These radiotherapy-related adverse reactions are known as radiation toxicity or radiation injury. Radiation injury manifests in various forms, commonly including radiation pneumonitis, radiation enteritis, radiation oral mucositis, and radiation dermatitis, severely impacting patients' quality of life and even shortening their survival. Because the pathological mechanisms of radiation injury are not fully understood, modern medicine struggles to develop standardized and effective prevention and treatment protocols, leading to delays in the treatment of radiation injury. Currently, radiation injury prevention measures are extremely limited. While radiation shielding agents are effective, their economic burden often prevents them from being considered by most people. Treatment focuses primarily on the development of anti-inflammatory, antioxidant, and cytokine agents, but due to the complexity of the tumor environment, the selection of low-toxicity, highly effective drugs is extremely limited. Over the past decade or so, as natural medicines have become increasingly involved in the treatment of tumors, traditional Chinese medicine has also played an increasingly prominent role in the prevention and treatment of radiation damage. It has the advantages of significant efficacy, low price and few side effects. In particular, traditional Chinese medicines that are both food and medicine are highly favored because of their "zero toxicity" characteristics.

[0003] Radiation, being ionizing radiation, is an external poison. Due to its specific pathogenic characteristics, it is often categorized under the category of "fire-heat toxins" in Traditional Chinese Medicine, also known as "ionizing poisons." Its pathological nature is particularly characterized by heat and dryness. Fire and heat are yang evils, with an upward-flaming nature, easily scorching yin fluids. The fire-heat toxin easily damages body fluids and depletes qi, causing the limbs to become malnourished and the nine orifices to become dry, resulting in a syndrome of both qi and yin deficiency. Since body fluids and blood share the same origin, the depletion of yin fluids also leads to a deficiency of blood, causing the blood vessels to become empty and blood circulation to become stagnant. Alternatively, the fire toxin may directly damage the blood vessels, forcing blood to flow erratically, causing blood to overflow outside the vessels, resulting in blood stasis. Or, blood and heat may combine to form blood stasis. Therefore, we believe that the pathogenesis of radiation damage can be summarized as primarily qi and yin deficiency, accompanied by blood stasis, generally a syndrome of deficiency in the root and excess in the branch. Prolonged illness deprives the five internal organs of nourishment. Damage to the liver leads to emotional instability, damage to the heart to sleep disorders, damage to the spleen and stomach to impaired digestion, damage to the lungs to dry throat and mouth, damage to the kidneys to impaired lower jiao (lower burner), and damage to the large intestine to impaired transmission. Radiation damage can cause a variety of symptoms, including fatigue, dry mouth, pain, irritability, spontaneous sweating, night sweats, insomnia, dark yellow urine, and constipation. Therefore, the treatment of radiation damage should combine methods such as tonifying the body's resistance, replenishing qi and nourishing yin, and promoting blood circulation and removing blood stasis. Prevention and treatment should be combined, and both traditional Chinese and Western medicine should be used together to maintain the body's ability to eliminate cancer toxins, while preventing the harmful effects of radiation damage to body fluids and qi. Summary of the Invention

[0004] Purpose of the invention: The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine compound with a scientifically reasonable formulation and significant effect in preventing and treating radiation damage; another purpose of this invention is to provide a method for preparing the traditional Chinese medicine compound composition and its application.

[0005] Technical solution: To achieve the above objectives, the technical solution adopted by this invention is as follows: A traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage is made from the following raw materials in parts by weight: American ginseng 5-15 parts, sea buckthorn 3-6 parts, and polygonatum 10-30 parts.

[0006] As a preferred embodiment, the above-mentioned traditional Chinese medicine compound composition with the function of preventing and treating radiation damage is made from the following raw materials in parts by weight: 10-15 parts of American ginseng, 5-6 parts of sea buckthorn, and 15-30 parts of polygonatum.

[0007] As a more preferred embodiment, the above-mentioned traditional Chinese medicine compound composition with the function of preventing and treating radiation damage is made from the following raw materials in parts by weight: 15 parts American ginseng, 6 parts sea buckthorn, and 30 parts Polygonatum sibiricum.

[0008] Based on the theory of syndrome differentiation and treatment in traditional Chinese medicine, this invention has screened the formula through a large number of clinical trials. The entire Chinese herbal compound is used to prevent and treat radiation damage, with symptoms such as dry mouth and throat, fatigue and poor appetite, chest tightness and shortness of breath, restlessness and insomnia, dry stools, dark yellow urine, or even oral and skin erosion, red tongue with little coating, and thready pulse.

[0009] In the compound formula: American ginseng, which is sweet and slightly bitter in taste and cool in nature, replenishes qi and nourishes yin, clears heat and generates fluids, and enters the heart, spleen and kidney meridians; it is the principal ingredient.

[0010] Sea buckthorn, with a sour and astringent taste and warm nature, enters the spleen, stomach, lung, and heart meridians. It invigorates blood circulation, removes blood stasis, strengthens the spleen and aids digestion, and relieves cough and phlegm. Polygonatum, with a sweet taste and neutral nature, enters the spleen, lung, and kidney meridians. It can replenish qi and nourish yin, strengthen the spleen, moisten the lungs, and benefit the kidneys. The two are used as assistant herbs. The combination of these herbs in this invention has the effects of invigorating qi and nourishing yin, clearing heat and promoting body fluid production, and promoting blood circulation and removing blood stasis. It has a good preventive and therapeutic effect on tumor-related radiation-induced oral mucositis and other conditions.

[0011] A drug with the function of preventing and treating radiation damage is prepared by using an extract of the traditional Chinese medicine compound composition of the present invention and a pharmaceutically acceptable carrier into an oral liquid, granule, capsule, pill, tablet, powder injection, drop pill or injection dosage form.

[0012] When preparing the extracts of each raw material of the traditional Chinese medicine compound provided by the present invention into an oral liquid, the extracts of each raw material are dissolved in distilled water, filtered, and the pH value is adjusted to prepare the oral liquid.

[0013] When the extracts of the raw materials of the traditional Chinese medicine compound provided by the present invention are made into tablets, the raw materials and lactose or corn starch, and lubricants such as magnesium stearate are added as needed, mixed evenly, granulated, and then compressed into tablets.

[0014] When the extract of the traditional Chinese medicine compound provided by the present invention is made into capsules, the extracts of each raw material and excipients such as carrier lactose or corn starch are mixed evenly, granulated, and then filled into capsules to make capsules.

[0015] When the extracts of each raw material in the traditional Chinese medicine compound provided by the present invention are made into granules, the extracts of each raw material and the diluent lactose or corn starch are mixed evenly, granulated, dried and made into granules.

[0016] When the extracts of each raw material in the traditional Chinese medicine compound provided by the present invention are made into powder injections, the extracts of each raw material are freeze-dried and sterilized to make powder injections.

[0017] When the extracts of each raw material of the traditional Chinese medicine compound provided by the present invention are made into an injection, the extracts of each raw material are dissolved in physiological saline, then activated carbon is added, stirred evenly, heated at 80°C for 30 minutes, filtered, pH value is adjusted, filtered until clear using a sintered glass funnel or other filter, filled into bottles, and sterilized at 100 to 115°C for 30 minutes to make an injection.

[0018] The method for preparing the drug with radiation-induced damage prevention and treatment effect according to the present invention includes the following steps: (1) Take American ginseng, sea buckthorn and polygonatum according to the weight parts, extract them with water to obtain an aqueous extract, concentrate them to obtain an extract, and set aside for later use; (2) Take the extract from step (1) and prepare it into an oral liquid, granule, capsule (including soft capsule), pill, tablet, powder for injection, drop pill or injection dosage form.

[0019] As a preferred option, the preparation method of the drug with the function of preventing and treating radiation damage described above, the extraction method of step (1) is decoction, maceration or reflux extraction, the amount of water added is 6 to 15 times the weight of the medicinal material, the number of extractions is 1 to 3 times, and the extraction time is 0.5h to 2h.

[0020] As a preferred option, the above step (1) involves adding water and decocting for extraction three times, with the amount of water added being 8 times, 6 times, and 6 times respectively, and the extraction time being 2 hours, 1 hour, and 1 hour respectively.

[0021] The application of the traditional Chinese medicine compound composition with the function of preventing and treating radiation damage described in this invention in the preparation of drugs for the prevention and treatment of radiation damage.

[0022] Beneficial effects: The advantages of the traditional Chinese medicine compound composition with radiation damage prevention and treatment effects provided by this invention are as follows: Based on the principles of traditional Chinese medicine (TCM) syndrome differentiation and treatment, this invention utilizes a combination of herbs that synergistically invigorate Qi and nourish Yin, clear heat and generate fluids, and promote blood circulation and remove blood stasis. Clinical trial results show that the TCM compound composition provided by this invention has significant preventive and therapeutic effects on symptoms such as dry mouth and throat, fatigue, poor appetite, chest tightness, shortness of breath, constipation, and insomnia after radiotherapy. Furthermore, it is safe for clinical use and has no obvious toxic side effects.

[0023] Furthermore, network pharmacology studies have shown that the traditional Chinese medicine compound composition described in this invention, which has the effect of preventing and treating radiation damage, has a good intervention effect on radiation-induced oral mucositis, exhibiting multi-target and multi-pathway action characteristics. The effective components of the traditional Chinese medicine compound have 131 target sites that interact with radiation-induced oral mucositis. Topological analysis revealed 10 core target sites, corresponding to the genes AKT1, TNF, STAT3, CASP3, EGFR, HIF1A, BCL2, SRC, MMP9, and PTGS2, which show a good correlation with radiation damage.

[0024] The method for preparing traditional Chinese medicine compound compositions provided by this invention has a reasonable process design. It uses optimized industrial extraction methods to extract the active ingredients of each Chinese medicinal material separately. The resulting Chinese medicine extract has high active ingredients and few impurities, and can be made into various dosage forms required for clinical use, enabling large-scale industrial production. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the drug-disease co-target, also known as a Venn diagram.

[0026] Figure 2It is a PPI network diagram.

[0027] Figure 3 It is a drug-active ingredient-target-disease network.

[0028] Figure 4 It is a GO term enrichment bar chart.

[0029] Figure 5 It is a KEGG enrichment bubble chart.

[0030] Figure 6 It is a heat map of binding energy.

[0031] Figure 7 It is a visualization of molecular docking. Detailed Implementation

[0032] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. After reading the present invention, any modifications of the present invention in various equivalent forms by those skilled in the art will fall within the scope defined by the appended claims.

[0033] Example 1 1. A traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage, which is made from the following raw materials in parts by weight: American ginseng 5g, sea buckthorn 3g, and polygonatum 15g.

[0034] 2. The preparation method of the traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage according to the present invention includes the following steps: (1) Take 5g of American ginseng, 3g of sea buckthorn, and 15g of polygonatum, and make it into a tea substitute. (Batch No.: 001) Example 2 1. A traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage, which is made from the following raw materials in parts by weight: American ginseng 15g, sea buckthorn 6g, and polygonatum 30g.

[0035] 2. The preparation method of the traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage according to the present invention includes the following steps: (1) Take 15g of American ginseng, 6g of sea buckthorn and 30g of polygonatum, add water and decoct to extract 3 times (the amount of water added is 8 times, 6 times and 6 times respectively, and the extraction time is 2h, 1h and 1h respectively), combine the 3 extracts, concentrate to obtain Chinese herbal compound extract (extract), and set aside. (2) Take the extract from step (1), add an appropriate amount of corn starch, mix well, dry, and make into granules. (Batch No.: 002) Example 3 1. A traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage, which is made from the following raw materials in parts by weight: American ginseng 15g, sea buckthorn 6g, and polygonatum 30g.

[0036] 2. The preparation method of the traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage according to the present invention includes the following steps: (1) Take 15g of American ginseng, 6g of sea buckthorn, and 30g of polygonatum. Soak them in water for 30 minutes, then decoct twice (add water 3-5cm above the herbs for the first time, and add water to the herbs for the second time; bring to a boil over high heat, then simmer over low heat for 20 minutes). Combine the two decoctions, put them in a bag, and prepare a decoction substitute (approximately 200ml per dose). (Batch No.: 003) Example 4 Network Pharmacology Study 1. Target screening 1.1 Drug Targets The drug components of "American ginseng," "sea buckthorn," and "Polygonatum" were searched in the TCMSP database using "Herb name." Oral bioavailability (OB) ≥30% and drug-likeness (DL) ≥0.18 were set as screening criteria to obtain effective active pharmaceutical ingredients. The target sites corresponding to the active ingredients were obtained from the Swiss Target Prediction database. The gene names of the target sites were standardized using the Uniprot database, and after deduplication, 523 drug targets were obtained.

[0037] 1.2 Disease Targets Using "Radiation-induced oral mucositis" as the keyword, searches were conducted in the OMIM, Genecard, and TTD databases, and 602 disease targets were obtained after deduplication.

[0038] 1.3 Drug-Disease Co-target By taking the intersection of drug targets and disease targets, we obtained 131 drug-disease co-acting targets. We then used the MicroBioinformatics platform to draw a Venn diagram, as shown in Figure 1.

[0039] 2. Construction of Protein-Protein Interaction (PPI) Networks and Drug-Active Ingredient-Target-Disease Networks 2.1 PPI Network Construction The intersection target points were input into the STRING database to construct a protein-protein interaction (PPI) network, as shown in Figure 2. The resulting PPI network data was then imported into Cytoscape software, and the Analyze Network module was used to perform topology analysis to obtain the core target points.

[0040] 2.2 Construction of Drug-Active Ingredient-Target-Disease Network By integrating the intersection targets and their corresponding drugs and active ingredients, topological analysis was performed using Cytoscape software to obtain key compounds, and a drug-active ingredient-target-disease network diagram was further constructed, as shown in Figure 3.

[0041] core target

[0042] Key compounds

[0043] 3. Enrichment Analysis Intersecting targets were imported into the DAVID database for enrichment analysis of gene ontology (GO) functions and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways. The biological processes (BP), cellular components (CC), molecular functions (MF) included in the GO enrichment analysis and the KEGG enrichment analysis data were sorted according to P-value. The GO term enrichment bar chart (Figure 4) and the KEGG enrichment bubble chart (Figure 5) were plotted using the MicroBioinformatics platform.

[0044] 4 Results Analysis Network pharmacology results showed that the traditional Chinese medicine compound composition with radiation-induced damage prevention and treatment effects provided by this invention has a good intervention effect on radiation-induced oral mucositis, exhibiting multi-target and multi-pathway action characteristics. The effective components of the traditional Chinese medicine compound interact with 131 targets associated with radiation-induced oral mucositis. Topological analysis revealed 10 core targets, corresponding to the genes AKT1, TNF, STAT3, CASP3, EGFR, HIF1A, BCL2, SRC, MMP9, and PTGS2, which showed good correlation with radiation-induced oral mucositis. The increased transcriptional and protein expression of TNF-α, STAT3, and SRC in irradiated cells and mouse radiation injury models has been confirmed. The mechanism of action of the traditional Chinese medicine compound composition in this invention may be related to its effective components inhibiting intracellular TNF / STAT3 / SRC signal transduction, thereby exerting an anti-inflammatory effect. Under hypoxic conditions, the HIF family can activate the expression of target genes such as VEGF and EPO, regulating adaptive responses such as angiogenesis, erythropoiesis, and glycolysis. Ionizing radiation increases the expression of genes such as HIF-2α and HIF-1α, which are associated with increased expression of genes driving inflammation, cytokines, growth factors, and chemokines. Simultaneously, HIF-1α can transform sublethal radiation damage into lethal damage by inducing abnormal mitosis in endothelial cells and tumor cells. Experiments have shown that targeted inhibition of HIF-1α in endothelial cells can reduce vascular damage in mouse radiation injury models, inhibit skin fibrosis and DNA damage after radiation-induced skin ulcers, and is also key to reducing reactive oxygen species (ROS) damage, thereby promoting high-quality healing of radiation-induced skin ulcer wounds.

[0045] Ten compounds with good activity were extracted from the traditional Chinese medicine compound composition for preventing and treating radiation damage described in this invention. These compounds are baicalin, 4',5-dihydroxyflavone, and glycyrrhizin derived from Polygonatum sibiricum; PQ-2 and papaverine derived from Panax quinquefolius; and isorhamnetin, quercetin, pelargonidin / hesperidin, kaempferol, and (±)-hesperidin derived from Hippophae rhamnoides. Enrichment analysis results indicate that the active ingredients in the traditional Chinese medicine compound composition for preventing and treating radiation damage described in this invention can activate various enzyme activities, affect ATP binding, influence the activity of brain-derived neurotrophic factor receptors, platelet-derived growth factor α receptors, and other receptor activities in various organelles such as cytoplasm, cytoplasm, nucleus, and plasma membrane. These active components then participate in diverse biological processes such as the regulation of epidermal growth factor receptor signaling pathways in the oral cavity, the regulation of nerve cell synaptic receptor signaling pathways, and the negative regulation of apoptosis, thereby exerting a stable effect in preventing and treating radiation damage.

[0046] In exploring the microscopic pathways through which the effective components of the traditional Chinese medicine compound in this invention act on radiation damage, besides cancer pathways, the most common pathways include the EGFR tyrosine kinase inhibitor resistance pathway, the proteoglycan pathway in cancer, the central carbon metabolism pathway in cancer, the PI3K-Akt signaling pathway, the lipid and atherosclerosis pathway, the C-type lectin receptor signaling pathway, HIF-1, and FoxO pathways. Among these, the PI3K-Akt signaling pathway has been confirmed to be activated in radiation damage. Downstream target genes of the FoxO signaling pathway include antioxidant superoxide dismutase (SOD), DNA damage repair enzymes, and apoptosis-related genes, the expression regulation of which is involved in the occurrence of radiation damage. Under normal circumstances, the FoxO pathway is activated and phosphorylated by PKB / Akt, making it difficult to locate in the cell nucleus and detached from the promoter region of target genes, thus preventing its participation in transcriptional regulation. Under stress or conditions such as PKB / Akt inactivation and MAPK activation, the FoxO transcription factor translocates from the cytoplasm to the nucleus, binds to the corresponding promoter region on DNA, and participates in the expression and regulation of downstream genes. The active ingredients in the traditional Chinese medicine compound composition for preventing and treating radiation damage described in this invention may exert antioxidant and DNA-repairing effects by negatively regulating the PI3K-Akt signaling pathway and simultaneously activating the FoxO signaling pathway, thus providing a positive intervention effect against radiation damage. Furthermore, studies have shown that high expression of HIF-1 protein has a certain repair effect on radiation-induced intestinal and hematopoietic system damage in mice. miR-21 can promote angiogenesis and osteogenic differentiation in the jawbone of rats and dogs by activating the HIF-1 pathway. In contrast to HIF-1α, HIF-1 plays a role in improving hypoxia, promoting angiogenesis, and regulating energy metabolism during the repair of radiation damage.

[0047] Example 5 Molecular docking 1. Document Preparation The 3D protein crystal structure of the core target was obtained from the RCSB PDB database, the 2D structure of the key small molecule compound was obtained from the PubChem database, and the 3D structure and format were converted using ChemDraw software.

[0048] 2. Molecular docking Molecular docking was performed using AutoDockTools software, as shown in Table 1. A heatmap was plotted based on the binding energy, as shown in Figure 6. The docking result with the optimal binding energy was selected from each group and visualized using PyMol software, as shown in Figure 7.

[0049] Table 1 Molecular docking binding energy (kcal·mol) -1 )

[0050] 3 Results Analysis After molecular docking between the core target and the key compound, relatively good binding energies were obtained. For example, in the PTGS2 gene, the optimal binding energy was -9.5 kcal·mol⁻¹. -1 The first is produced by the docking of (±)-hesperidin derived from sea buckthorn with the protein fragment corresponding to PTGS2; the second is -9.4 kcal·mol⁻¹. -1 It is produced by docking PTGS2, a geranium derived from sea buckthorn; the third is -9.1 kcal·mol⁻¹. -1 It is produced by the docking of glycyrrhizin derived from Polygonatum odoratum with PTGS2; the fourth is -9.0 kcal·mol -1 This is produced by the docking of quercetin derived from sea buckthorn with PTGS2. The visualization results of the molecular docking of the top four are detailed in Figure 7.

[0051] Example 6 Clinical Study I. Clinical Research: Through retrospective studies, the efficacy and safety of the traditional Chinese medicine compound composition of this invention in treating radiation damage are evaluated.

[0052] 1. Inclusion criteria: ① Pathological histology meets the diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Common Malignant Tumors in China" compiled by the Medical Administration Department of the National Health Commission of the People's Republic of China; ② Malignant tumor patients who have received conventional radiotherapy; ③ No history of other malignant tumors or other serious diseases that conflict with the study; ④ Expected survival of more than six months; ⑤ Can be followed up.

[0053] 2. Study Subjects and Grouping: One hundred cancer patients who underwent radiotherapy were included. Before the trial, a random number table was generated using SAS software to screen and enroll eligible subjects, who were divided into an observation group and a control group, with 50 patients in each group. There were no statistically significant differences in the general characteristics of the two groups before treatment (P > 0.05), indicating comparability. Group A was the experimental group, receiving the traditional Chinese medicine compound granules prepared according to Example 2 of this invention; Group B was the control group, receiving no traditional Chinese medicine.

[0054] 3. Observation indicators: The primary endpoint indicator was the TCM syndrome score of radiation injury.

[0055] 4. Observation of efficacy and statistical data: Through self-comparison before and after treatment, and comparison and statistical processing between the treatment group and the control group, the clinical efficacy and safety of the traditional Chinese medicine compound composition in the treatment of radiation injury were studied.

[0056] 5. Results: 5.1 Statistical Analysis Methods Within-group comparisons were performed for both the control and treatment groups before and after treatment. Between-group comparisons were also performed for post-treatment data between the control and treatment groups. SPSS software was used to conduct paired-samples t-tests, independent-samples t-tests, and Wilcoxon signed-rank tests.

[0057] 5.2 Statistical Results Table 2 shows the comparison before and after treatment within each group. * p <0.05, ** p <0.01; Comparison between the treatment group and the control group, △ p <0.05, △△ p <0.01, NS No significance. In the self-comparison before and after treatment, the total score of the treatment group ( p <0.01), fatigue and weakness ( p <0.01), lethargic and reluctant to speak ( p <0.01), dry mouth ( p <0.01), sleep ( p Significant differences were observed in aspects such as <0.01, with most pre-treatment scores > post-treatment scores. Among the inter-group comparisons of post-treatment scores, the total score ( p <0.01), fatigue and weakness ( p <0.01), lethargic and reluctant to speak ( p <0.01), dry mouth ( p <0.01), sleep ( p Significant differences were observed in aspects such as <0.01. This suggests that the treatment group experienced symptom improvement after receiving radiotherapy and using the traditional Chinese medicine compound composition of this invention, while the control group, which received radiotherapy alone, showed a tendency for symptom exacerbation in various aspects.

[0058] Table 2 Comparison of TCM syndrome scores before and after treatment in the treatment group and the control group ( ±s)

[0059] Note: Comparison before and after treatment within the group * p <0.05, ** p <0.01; Comparison between the treatment group and the control group, △ p <0.05, △△ p <0.01, NS No significance.

[0060] Within the group: Treatment group: 11 p =0.029, 12 p =0.109; 1 p , 2 p , 3 p , 4 p , 5 p , 6 p , 7 p , 8 p , 13 p All <0.01; 9 p , 10 p All <0.05; Control group: e p =0.102, f p =0.317, g p =0.132, h p =0.157, i p =0.096, l p =0.414, m p =1.000; a p , b p , c p , d p All <0.01; j p , k p All <0.05.

[0061] Between groups: NS5 p =0.402, NS7 p =0.495, NS9 p =0.181.

[0062] This invention, based on traditional Chinese medicine theory and the clinical manifestations of radiation injury, categorizes the pathogenesis of radiation injury into a primary condition of Qi and Yin deficiency, accompanied by blood stasis. Treatment employs methods such as tonifying Qi and nourishing Yin, clearing heat and generating fluids, and promoting blood circulation and removing blood stasis. Through extensive experimental screening, the optimal traditional Chinese medicine compound obtained in this invention consists of: American ginseng, sea buckthorn, and polygonatum. American ginseng, sweet and slightly bitter in taste, cool in nature, tonifies Qi and nourishes Yin, clears heat and generates fluids, and enters the heart, spleen, and kidney meridians; it is the principal herb. Sea buckthorn, sour and astringent in taste, warm in nature, enters the spleen, stomach, lung, and heart meridians, strengthens the spleen and promotes digestion, relieves cough and eliminates phlegm, and promotes blood circulation and removes blood stasis; polygonatum, sweet in taste, neutral in nature, enters the spleen, lung, and kidney meridians, and tonifies Qi and nourishes Yin, strengthens the spleen, moistens the lungs, and benefits the kidneys; these are the assistant herbs. The combined effects of these herbs tonify Qi, promote blood circulation, and nourish Yin. This formula tonifies Qi and nourishes Yin, clears heat and generates fluids, and promotes blood circulation and removes blood stasis. It has a good preventive and therapeutic effect on radiation injury.

[0063] Based on traditional Chinese medicine theory, this invention uses the theory of syndrome differentiation and treatment to formulate the prescription. The above research results show that the traditional Chinese medicine compound provided by this invention has the effect of preventing and treating radiation damage, and no adverse reactions have been observed with long-term use of this traditional Chinese medicine compound in clinical application, indicating that the medication is safe.

[0064] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage, characterized in that, It comprises the following ingredients in parts by weight: 5-15 parts American ginseng, 3-6 parts sea buckthorn, and 10-30 parts Polygonatum.

2. The traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage according to claim 1, characterized in that, It comprises the following ingredients in parts by weight: 10-15 parts American ginseng, 5-6 parts sea buckthorn, and 15-30 parts Polygonatum.

3. The traditional Chinese medicine compound composition with the effect of preventing and treating radiation damage according to claim 2, characterized in that, It comprises the following ingredients in parts by weight: 15 parts American ginseng, 6 parts sea buckthorn, and 30 parts Polygonatum sibiricum.

4. A drug with the function of preventing and treating radiation damage, characterized in that, The extract of the traditional Chinese medicine compound composition according to any one of claims 1 to 3 and a pharmaceutically acceptable carrier are prepared.

5. The drug for preventing and treating radiation damage according to claim 4, characterized in that, Drug dosage forms include oral liquids, granules, capsules, pills, tablets, powder for injection, drop pills, or injection solutions.

6. The method for preparing the drug with the effect of preventing and treating radiation damage as described in claim 4, characterized in that, Includes the following steps: (1) Take American ginseng, sea buckthorn and polygonatum in the weight proportions according to any one of claims 1 to 3, add water to extract, obtain water extract, concentrate to obtain extract, and use for later use; (2) Take the extract from step (1) and prepare a traditional Chinese medicine preparation with a pharmaceutically acceptable carrier.

7. The method for preparing a drug with radiation-induced damage prevention and treatment effect according to claim 6, characterized in that, Step (1) The extraction method is decoction, soaking or reflux extraction. The amount of water added is 6 to 15 times the weight of the medicinal material. The number of extractions is 1 to 3 times and the extraction time is 0.5h to 2h.

8. The method for preparing a drug with radiation-induced damage prevention and treatment effect according to claim 6, characterized in that, Step (1) Add water and decoct three times, with the amount of water added being 8 times, 6 times, and 6 times respectively, and the extraction time being 2 hours, 1 hour, and 1 hour respectively.

9. The use of the traditional Chinese medicine compound composition according to any one of claims 1 to 3 in the preparation of drugs for preventing and treating radiation damage.

10. The use of the traditional Chinese medicine compound composition according to any one of claims 1 to 3 in the preparation of a drug for treating oral mucositis after tumor radiation.

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