Traditional Chinese medicine composition for treating radioactive injury and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating radioactive injury and application thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 100 to 200 parts of radix puerariae, 100 to 200 parts of radix scutellariae, 100 to 200 parts of rhizoma coptidis, 100 to 200 parts of poria cocos, 10 to 100 parts of liquorice root, 150 to 250 parts of rhizoma atractylodis macrocephalae stir-fried with bran, 150 to 250 parts of rhizoma dioscoreae, 100 to 200 parts of stir-fried fructus crataegi and 40 to 150 parts of radix linderae. The traditional Chinese medicine composition disclosed by the invention has the effects of clearing damp-heat, tonifying spleen deficiency and promoting qi stagnation, can be used for clinically treating radioactive injury, and particularly has remarkable effects on radioactive bowel diseases, radioactive stomach diseases, radioactive liver diseases, radiodermatitis, radioactive lung diseases, radioactive hematopoiesis inhibition and spleen injury.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating radiation damage and its application. Background Technology

[0002] With the widespread use of radiotherapy in the treatment of malignant tumors, the incidence of radiation-induced damage to the blood system and various organs is also on the rise. Radiation can cause damage to multiple organs, including the blood system, liver, kidneys, lungs, and skin. Among these, the intestines are particularly sensitive to ionizing radiation. Radiation-induced intestinal injury (RIII) is an intestinal complication caused by ionizing radiation damage to the intestines of patients with pelvic, abdominal, or retroperitoneal malignant tumors after radiotherapy.

[0003] Traditional Chinese medicine (TCM) views radiation as "fiery and toxic evil," directly attacking the intestines, burning blood vessels, and depleting qi and yin. In the acute phase, it is characterized by intense heat and toxicity, damp-heat accumulation, and blood stasis obstructing the channels; in the chronic phase, it is often seen as spleen deficiency with dampness, spleen and kidney yang deficiency, qi and yin deficiency, and internal blood stasis. The disease location is in the intestines, closely related to the spleen, stomach, and kidneys. RIII falls under the TCM categories of "dysentery," "hematochezia," "diarrhea," and "abdominal pain." Currently, clinical treatment mainly uses compound glutamine enteric-coated capsules, mesalazine enteric-coated tablets, amifostine, and bifidobacteria quadruple live bacteria tablets to prevent and treat RIII. However, due to poor treatment effects, the current approach mainly focuses on reducing radiation dose to alleviate RIII, but this also reduces the therapeutic effect on malignant tumors. Therefore, there is an urgent need to develop new drugs that can treat RIII.

[0004] Patent document CN202410876798.X (hereinafter referred to as "patent document") discloses a traditional Chinese medicine composition for treating radiation enteropathy, but its effect on treating RIII is limited and it does not show any protective effect against radiation-induced damage to the body's blood system and other organs. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention aims to provide a traditional Chinese medicine composition for treating radiation damage and its application. The traditional Chinese medicine composition of this invention has a better effect on treating radiation damage, especially radiation enteropathy.

[0006] This invention proposes a traditional Chinese medicine composition for treating radiation-induced damage. Based on the main pathogenesis of radiation-induced damage (preferably radiation-induced multi-organ damage), especially RIII, chronic colitis, irritable bowel syndrome with diarrhea, and post-chemotherapy diarrhea, the treatment principle is to clear damp-heat, tonify spleen deficiency, and promote qi circulation. Kudzu root is used to raise yang and stop diarrhea, combined with Scutellaria baicalensis and Coptis chinensis to clear heat and dry dampness, serving as the principal herbs. Stir-fried Atractylodes macrocephala is used to strengthen the spleen and dry dampness, while Dioscorea opposita nourishes yin and strengthens the kidneys, serving as the assistant herbs. Poria cocos drains dampness and promotes digestion, stir-fried hawthorn promotes digestion and relieves stagnation, while Lindera strychnifolia promotes qi circulation and relieves stagnation, serving as the adjuvant herbs. Licorice root is used to harmonize and alleviate urgency, serving as the guiding herb. Together, these nine herbs clear damp-heat, tonify spleen deficiency, and promote qi circulation. This combination is particularly effective in treating radiation-induced enteropathy, radiation-induced gastropathy, radiation-induced liver disease, radiation-induced dermatitis, radiation-induced lung disease, radiation-induced hematopoietic inhibition, and spleen damage.

[0007] Therefore, the first objective of this invention is to provide a traditional Chinese medicine composition for treating radiation damage, which is made from the following traditional Chinese medicine raw materials in parts by weight: 100-200 parts of kudzu root, 100-200 parts of scutellaria root, 100-200 parts of coptis root, 100-200 parts of poria cocos, 10-100 parts of licorice root, 150-250 parts of stir-fried atractylodes macrocephala, 150-250 parts of yam, 100-200 parts of stir-fried hawthorn, and 40-150 parts of lindera root.

[0008] Preferably, the traditional Chinese medicine composition for treating radiation damage is made from the following traditional Chinese medicine raw materials in parts by weight: 120-180 parts of kudzu root, 120-180 parts of scutellaria root, 120-180 parts of coptis root, 120-180 parts of poria cocos, 30-80 parts of licorice root, 170-220 parts of stir-fried atractylodes macrocephala, 170-220 parts of yam, 120-180 parts of stir-fried hawthorn, and 60-110 parts of lindera root.

[0009] More preferably, the traditional Chinese medicine composition for treating radiation damage is made from the following traditional Chinese medicine raw materials in parts by weight: 140-160 parts of kudzu root, 140-160 parts of scutellaria root, 140-160 parts of coptis root, 140-160 parts of poria cocos, 50-70 parts of licorice root, 190-210 parts of stir-fried atractylodes macrocephala, 190-210 parts of yam, 140-160 parts of stir-fried hawthorn, and 80-100 parts of lindera root.

[0010] More preferably, the traditional Chinese medicine composition for treating radiation damage is made from the following traditional Chinese medicine raw materials in parts by weight: 150 parts of kudzu root, 150 parts of scutellaria root, 150 parts of coptis root, 150 parts of poria cocos, 60 parts of licorice root, 200 parts of stir-fried atractylodes macrocephala, 200 parts of yam, 150 parts of stir-fried hawthorn, and 90 parts of lindera root.

[0011] Preferably, the radiation injury is radiation-induced multi-organ injury.

[0012] A second objective of this invention is to provide the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating radiation damage or functional impairment.

[0013] The radiation includes ionizing radiation, such as X-ray radiation and gamma-ray radiation.

[0014] Preferably, the radiation damage includes radiation enteropathy, radiation gastropathy, radiation liver disease, radiation dermatitis, radiation lung disease, radiation hematopoietic inhibition, and radiation spleen damage caused by ionizing radiation (e.g., X-rays, gamma rays).

[0015] Preferably, the radiation damage includes acute / chronic radiation enteropathy, ulcerative colitis, intestinal fibrosis, intestinal obstruction, and diarrhea caused by ionizing radiation (e.g., X-rays, gamma rays).

[0016] A third objective of this invention is to provide a medicament for treating radiation damage, comprising the above-described traditional Chinese medicine composition for treating radiation damage, and pharmaceutically acceptable excipients.

[0017] Preferably, the drug is administered orally or via enema, with oral administration being more preferred.

[0018] Preferably, the drug is a decoction, powder, pill, granule, tablet, capsule, syrup, or mixture; more preferably, it is a capsule, tablet, or granule.

[0019] A fourth object of the present invention is to provide a method for preparing the above-mentioned medicament for treating radiation damage, comprising the following steps: Soak the Chinese herbal raw materials in water, then heat and decoct them 1 to 3 times with 6 to 10 times the weight of water, each time for 1 to 3 hours. Filter, combine the filtrates, and concentrate them into an extract (e.g., relative density 1.20 to 1.30 (40 to 60°C)).

[0020] Preferably, the Chinese herbal raw materials are soaked in water, then boiled twice with 8 times their weight of water for 2 hours each time, filtered, and the filtrates are combined and concentrated into an extract (e.g., relative density 1.20~1.30 (40~60℃)).

[0021] Preferably, the soaking time is 30-135 min, more preferably 2 h.

[0022] Preferably, the method for preparing the drug for treating radiation damage further includes the following steps: The extract is dried, pulverized, granulated with 90% ethanol, mixed thoroughly, and then filled into capsules to obtain a capsule formulation; or Soluble starch and sucrose are added to the extract to form wet granules, which are then dried, sized, and sieved to obtain granules; wherein the mass ratio of the extract to soluble starch and sucrose is 0.5~1.5:0.3~1.5:0.1~1; or The extract is dried, pulverized, and passed through an 80-mesh sieve. Then, corn starch and sodium carboxymethyl starch are added, and granulation is performed using 95% ethanol as a binder. After drying, 1% magnesium stearate is added, mixed, and compressed into tablets to obtain tablets. The mass ratio of the dry extract powder to corn starch and sodium carboxymethyl starch is 1~3:0.5~2.5:0.3~2.

[0023] The traditional Chinese medicine composition of this invention has the effects of clearing damp-heat, tonifying spleen deficiency, and promoting qi circulation. It can treat radiation-induced enteropathy, radiation-induced gastropathy, radiation-induced liver disease, radiation-induced dermatitis, radiation-induced lung disease, radiation-induced hematopoietic inhibition, and spleen damage caused by ionizing radiation (such as X-rays and gamma rays). Pharmacodynamic tests show that the traditional Chinese medicine composition of this invention can alleviate radiation-induced damage to the intestines, stomach, liver, spleen, and blood system, and has significant therapeutic effects. Attached Figure Description

[0024] Figure 1A This is the HE staining result of the traditional Chinese medicine composition of this invention reducing pathological damage to rat intestinal tissue after irradiation.

[0025] Figure 1B This is the scoring result of the traditional Chinese medicine composition of the present invention reducing the pathological damage of rat intestinal tissue after irradiation.

[0026] Figure 1C This is the result of the traditional Chinese medicine composition of the present invention reducing damage to the intestinal villi of rats after irradiation.

[0027] Figure 1D This is the result of the traditional Chinese medicine composition of the present invention reducing the damage to the intestinal crypts of rats after irradiation.

[0028] Figure 2A This is the result of the traditional Chinese medicine composition of the present invention reducing diarrhea in rats after irradiation.

[0029] Figure 2B This is a statistical graph showing how the herbal composition of this invention reduces diarrhea in rats after irradiation.

[0030] Figure 3A This is the HE staining result of the traditional Chinese medicine composition of this invention reducing the pathological damage to the spleen of rats after irradiation.

[0031] Figure 3B This is the result of the traditional Chinese medicine composition of the present invention reducing the pathological damage score of the spleen in rats after irradiation. Detailed Implementation

[0032] The following are typical embodiments to further illustrate the present invention, but they do not constitute a limitation on the scope of protection of the present invention. Note: The ratio of water added to the Chinese herbal raw materials is a mass ratio.

[0033] Example 1 Soak 150 g of kudzu root, 150 g of scutellaria root, 150 g of coptis root, 150 g of poria cocos, 60 g of licorice root, 200 g of stir-fried atractylodes macrocephala, 200 g of yam, 150 g of stir-fried hawthorn, and 90 g of lindera root in 10.4 L of water for 2 hours. Decoction of the soaking liquid and the dregs for 2 hours, filter, collect the filtrate, add 10.4 L of water to the dregs, decoct for 2 hours, combine the filtrates and concentrate into an extract.

[0034] Example 2 Soak 200 g of kudzu root, 200 g of scutellaria root, 200 g of coptis root, 200 g of poria cocos, 30 g of licorice root, 150 g of stir-fried atractylodes macrocephala, 150 g of yam, 100 g of stir-fried hawthorn, and 40 g of lindera root in 10.16 L of water for 2 hours. Decoction of the soaking liquid and the dregs for 2 hours, filter, collect the filtrate, add 10.16 L of water to the dregs, decoct for 2 hours, combine the filtrates and concentrate into an extract.

[0035] Example 3 Soak 100 g of kudzu root, 100 g of scutellaria root, 100 g of coptis root, 100 g of poria cocos, 100 g of licorice root, 250 g of stir-fried atractylodes macrocephala, 250 g of yam, 200 g of stir-fried hawthorn, and 150 g of lindera root in 10.8 L of water for 2 hours. Decoction of the soaking liquid and the dregs for 2 hours, filter, collect the filtrate, add 10.8 L of water to the dregs, decoct for 2 hours, combine the filtrates and concentrate into an extract.

[0036] Example 4 The extract obtained in Example 1 was dried, pulverized, granulated with 90% ethanol, mixed, and then directly filled into capsules to obtain capsules.

[0037] Example 5 The extract obtained in Example 2 was dried, pulverized, and passed through an 80-mesh sieve. Then, corn starch and sodium carboxymethyl starch were added, wherein the mass ratio of the dry extract powder to corn starch and sodium carboxymethyl starch was 2:1.6:1.3. Granulation was performed using 95% ethanol as a binder. After drying, 1% magnesium stearate was added, mixed well, and compressed into tablets to obtain tablets.

[0038] Example 6 The extract obtained in Example 3 was concentrated to a relative density of 1.28 (40~60℃), and then soluble starch and sucrose were added, wherein the mass ratio of the extract to soluble starch and sucrose was 1:1:0.5. Wet granules were prepared, dried, and sieved to obtain granules.

[0039] Experimental Example 1: Study on Extraction Process (1) Selection of soaking time for Chinese herbal raw materials: A single-factor study was conducted on the soaking time of Chinese herbal raw materials, using the water absorption saturation time as the evaluation index. The prescribed amount of Chinese herbal raw materials were weighed, placed in a container, water was added, and the container was sealed. The wet weight of the Chinese herbal raw materials was measured at different soaking times, and the water absorption rate of the Chinese herbal raw materials was calculated. Water absorption rate = (wet weight of Chinese herbal raw materials - dry weight of Chinese herbal raw materials) / dry weight of Chinese herbal raw materials × 100%. The results are shown in Table 1.

[0040] Table 1 Results of water absorption rate study of Chinese medicinal raw materials

[0041] The experimental results showed that the Chinese herbal medicine raw materials reached water saturation after soaking for 2 hours. Therefore, it was chosen to soak for 2 hours before decoction.

[0042] (2) Selection of decoction conditions: Taking the extract yield as the indicator, the main factors affecting the extraction effect were set as the water addition ratio A (6 times, 8 times, 10 times), the number of decoctions as B (1 time, 2 times, 3 times), and the decoction time as C (60 min, 90 min, 120 min). L9 (3 4 An orthogonal experiment was conducted to select the optimal decoction conditions. The results are shown in Table 2.

[0043] Table 2 Results of the investigation on decoction conditions

[0044] The experimental results show that, with the extract yield as the evaluation index, the optimal decoction conditions are A2B2C3, which means adding 8 times the amount of water, decoct twice, and decoct for 2 hours each time.

[0045] Experimental Example 2: Traditional Chinese Medicine Composition Reduces Pathological Damage to Intestinal Tissue in Rats After Irradiation This experiment used healthy adult SD rats aged 6-9 weeks (180-220 g), with an equal number of males and females. After a week of acclimatization, subsequent experiments were conducted. The experimental procedure and related operations were approved by the Experimental Animal Center of Northwest A&F University.

[0046] Experimental grouping and model establishment: Rats were divided into a normal group, a model group, and a drug-treated group. The drug-treated group included the Example 1 group, Example 2 group, Example 3 group, positive control compound glutamine enteric-coated capsule group, and the patent literature group (the extract was prepared according to the preparation example 3 in patent literature 202410876798.X), with 8 rats in each group. A rat radiation intestinal injury model was established by a single irradiation of the abdomen using X-ray in 6MV mode, with a source-to-skin distance of 100.5 cm, a dose rate of 400 MU / min, a field of view of 30 cm × 30 cm, and a total dose of 10 Gy per rat. After model establishment, the rats were administered the drug via gavage for 7 consecutive days. On the 7th day after gavage, the rats were fasted for 12 hours but allowed free access to water before being sacrificed and the tissue collected.

[0047] Experimental Methods: Hematoxylin-eosin (H&E) staining of rat intestinal tissue and Chiu's score of intestinal mucosa. Rat intestinal tissue was fixed in 4% paraformaldehyde for 24 h, then embedded in paraffin and sectioned. Tissue sections were soaked in xylene I and II for 30 min each; then soaked in ethanol of different concentrations, rinsed with distilled water for 3 min each; followed by H&E staining; mounted with neutral resin, and observed and photographed under an optical microscope. Pathological changes in the intestinal mucosa were scored using the Chiu's score: 0 points, normal; 1 point, widening of the subepithelial space at the villus apex; 2 points, further widening of the subepithelial space at the villus apex, with elevation of the villus tip epithelium and separation from the lamina propria; 3 points, clumping of villus epithelium; 4 points, complete epithelial detachment, with only the lamina propria remaining; 5 points, rupture of the lamina propria, with hemorrhage and ulceration. Experimental data are expressed as mean ± standard deviation. Intergroup comparisons were analyzed using t-tests. P <0.05 indicates a significant difference. The following experimental cases were all statistically analyzed using this method.

[0048] The results showed that the normal group rats had normal small intestinal morphology, with neat and intact intestinal villi, normal lamina propria morphology, and a large number of crypts, with clear structural layers from the mucosa to the serosa. The model group showed significant changes in intestinal histology, with significantly shortened and shed villi and epithelial necrosis, and marked destruction of crypt structure. Compared with the model group, the herbal composition of this invention significantly reduced intestinal mucosal atrophy and villus loss in irradiated rats, and lowered the Chiu's score for intestinal tissue damage, indicating that the herbal composition of this invention can alleviate pathological damage to rat intestinal tissue after irradiation. The results are shown in Table 3 and... Figure 1A , Figure 1B , Figure 1C , Figure 1D .

[0049] Table 3. Pathological damage to intestinal tissue in each group of rats

[0050] ## P <0.001 compared with the normal group; ** P <0.001 compared with the model group; * P <0.05 compared with the model group Experimental Example 3: Traditional Chinese Medicine Composition Reduces Diarrhea in Rats After Irradiation Experimental method: After modeling according to Example 2, the diarrhea status of rats in each group was observed and recorded daily.

[0051] Experimental Results: In the normal group, rats had clean tails and normal stools; in the model group, rats suffered from severe diarrhea and had heavily soiled tails; however, after intervention with the herbal composition of this invention, the diarrhea in rats was significantly alleviated. Scoring of diarrhea in each group revealed that diarrhea began to appear on the second day after irradiation, peaked on days 3-5, and then subsided. Compared to the model group, the diarrhea in rats after intervention with the herbal composition of this invention was significantly improved. Results are shown in Table 4 and... Figure 2A , Figure 2B .

[0052] Table 4. Diarrhea scores of rats in each group

[0053] ## P <0.001 compared with the normal group; ** P <0.001 compared with the model group; * P <0.05 compared with the model group Experimental Example 4: Traditional Chinese Medicine Composition Improves Hematological Conditions in Rats After Irradiation Experimental method: Blood was drawn from the orbital cavity and placed in an EDTA-K2 anticoagulant tube. After mixing by inverting the tube, the levels of white blood cells, platelets, lymphocytes, and neutrophils in the blood were detected by a fully automated blood cell analyzer.

[0054] Experimental Results: The blood system is highly sensitive to radiation. Our results showed that after 7 days of irradiation, compared to the normal group, the model group rats had decreased numbers of white blood cells, platelets, lymphocytes, and neutrophils. After intervention with the herbal composition of this invention, the numbers of white blood cells, platelets, lymphocytes, and neutrophils increased. The results are shown in Table 5.

[0055] Table 5 Hematological characteristics of rats in each group

[0056] ## P <0.001 compared with the normal group; ** P <0.001 compared with the model group; * P <0.05 compared with the model group Experimental Example 5: Traditional Chinese Medicine Composition Reduces Gastric Tissue Damage in Rats After Irradiation Experimental methods: After gavage on day 7, rats were fasted for 12 hours but allowed free water. They were then anesthetized and euthanized. Blood was collected from the orbital cavity, allowed to stand at room temperature for 30 minutes, and then centrifuged at 3500 rpm for 15 minutes. The supernatant was collected to obtain serum samples. The levels of gastrin (GAS) and pepsinogen II (PGII) in rat serum were detected by ELISA.

[0057] Experimental results: Compared with the normal group, the levels of GAS and PGII in the model group rats were increased. The traditional Chinese medicine composition of this invention can significantly reduce the levels of GAS and PGII in irradiated rats, and the effect is stronger than that of the positive control drug. The results are shown in Table 6.

[0058] Table 6. GAS and PGII levels in rats of each group

[0059] ## P <0.001 compared with the normal group; ** P <0.001 compared with the model group; * P <0.05 compared with the model group Experimental Example 6: Traditional Chinese Medicine Composition Reduces Liver and Spleen Damage in Rats After Irradiation Experimental Methods: After gavage on day 7, rats were fasted for 12 hours but allowed free access to water. They were then anesthetized and euthanized. Serum was collected from the rats according to the method described in Example 5. The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the serum of each group of rats were measured according to the kit instructions. The liver and spleen of each group of rats were harvested, weighed, and organ indices were calculated. The spleen was subjected to HE staining and pathological scoring. The HE staining method is described in Example 2. The spleen pathological score was: 0 points: The splenic corpuscles were significantly atrophied, the germinal centers were indistinct, and the white and red pulp structures were disordered with no clear boundary. Unidentifiable; splenic sinusoids dilated; severe interstitial hemorrhage; significant congestion; significantly reduced lymphocyte count; 1 point: Splenic corpuscles in the spleen are blurred; the germinal center, red pulp, and white pulp boundaries are still clear; some congestion and inflammatory cell infiltration are visible; 2 points: Splenic corpuscles in the spleen are visible; the germinal center, red pulp, and white pulp boundaries are still clear; no significant congestion is seen; inflammatory cell infiltration is reduced; 3 points: The red and white boundaries are clear; the germinal center and marginal zone are clear; no abnormalities are seen; no hyperplasia, atrophy, or hyalinization.

[0060] Experimental Results: Compared with the normal group, the model group rats showed significantly increased ALT and AST levels, spleen and liver atrophy, and significantly reduced organ indices after irradiation. In contrast, the herbal composition of this invention significantly improved serum ALT and AST levels, spleen and liver atrophy, and organ indices in the model rats, and improved spleen pathological damage. Results are shown in Table 7. Figure 3A , Figure 3B .

[0061] Table 7. Liver and spleen conditions in rats of each group

[0062] ## P <0.001 compared with the normal group; ** P <0.001 compared with the model group; * P <0.05 compared with the model group Based on the above description of the invention, those skilled in the art can fully apply the present invention, and all modifications based on the same principles or similar modifications should be considered to be included within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating radiation damage, characterized in that, Made from the following parts by weight of traditional Chinese medicine raw materials: 100-200 parts of kudzu root, 100-200 parts of scutellaria root, 100-200 parts of coptis root, 100-200 parts of poria cocos, 10-100 parts of licorice root, 150-250 parts of stir-fried atractylodes macrocephala, 150-250 parts of yam, 100-200 parts of stir-fried hawthorn, and 40-150 parts of lindera root.

2. The traditional Chinese medicine composition for treating radiation damage according to claim 1, characterized in that, Made from the following parts by weight of traditional Chinese medicine raw materials: 120-180 parts of kudzu root, 120-180 parts of scutellaria root, 120-180 parts of coptis root, 120-180 parts of poria cocos, 30-80 parts of licorice root, 170-220 parts of stir-fried atractylodes macrocephala, 170-220 parts of yam, 120-180 parts of stir-fried hawthorn, and 60-110 parts of lindera root; Preferably, it is made from the following parts by weight of traditional Chinese medicine raw materials: 140-160 parts of kudzu root, 140-160 parts of scutellaria root, 140-160 parts of coptis root, 140-160 parts of poria cocos, 50-70 parts of licorice root, 190-210 parts of stir-fried atractylodes macrocephala, 190-210 parts of yam, 140-160 parts of stir-fried hawthorn, and 80-100 parts of lindera root.

3. The traditional Chinese medicine composition for treating radiation damage according to claim 1, characterized in that, Made from the following parts by weight of traditional Chinese medicine raw materials: 150 parts of kudzu root, 150 parts of scutellaria root, 150 parts of coptis root, 150 parts of poria cocos, 60 parts of licorice root, 200 parts of stir-fried atractylodes macrocephala, 200 parts of yam, 150 parts of stir-fried hawthorn, and 90 parts of lindera root.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating radiation damage or functional impairment.

5. The application according to claim 4, characterized in that, The radiation damage includes radiation enteropathy, radiation gastropathy, radiation liver disease, radiation dermatitis, radiation lung disease, radiation hematopoietic suppression, and radiation spleen damage caused by ionizing radiation.

6. The application according to claim 4, characterized in that, The radiation damage includes acute / chronic radiation enteropathy, ulcerative colitis, intestinal fibrosis, intestinal obstruction, and diarrhea caused by ionizing radiation.

7. A drug for treating radiation damage, characterized in that, It comprises the traditional Chinese medicine composition according to any one of claims 1 to 3, and pharmaceutically acceptable excipients.

8. The medicament for treating radiation injury according to claim 7, characterized in that, The drug is administered orally or via enema, preferably orally; the drug is a decoction, powder, pill, granule, tablet, capsule, syrup, or mixture, preferably a capsule, tablet, or granule.

9. A method for preparing the drug according to claim 7 or 8, characterized in that, Includes the following steps: Soak the Chinese herbal raw materials in water, then heat and decoct them 1 to 3 times with 6 to 10 times the weight of water, each time for 1 to 3 hours. Filter, combine the filtrates, and concentrate them into an extract if necessary. Preferably, the Chinese herbal raw materials are soaked in water, then boiled twice with 8 times their weight of water for 2 hours each time, filtered, and the filtrates are combined and concentrated into an extract if not necessary.

10. The method for preparing the drug according to claim 9, characterized in that, It also includes the following steps: The extract is dried, pulverized, granulated with 90% ethanol, mixed thoroughly, and then filled into capsules to obtain a capsule formulation; or Soluble starch and sucrose are added to the extract to form wet granules, which are then dried, sized, and sieved to obtain granules; wherein the mass ratio of the extract to soluble starch and sucrose is 0.5~1.5:0.3~1.5:0.1~1; or The extract is dried, pulverized, and passed through an 80-mesh sieve. Then, corn starch and sodium carboxymethyl starch are added, and granulation is performed using 95% ethanol as a binder. After drying, 1% magnesium stearate is added, mixed, and compressed into tablets to obtain tablets. The mass ratio of the dry extract powder to corn starch and sodium carboxymethyl starch is 1~3:0.5~2.5:0.3~2.

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