Traditional Chinese medicine composition and suppository for treating radiation enteritis as well as preparation method and application of traditional Chinese medicine composition and suppository

Abstract

The invention discloses a traditional Chinese medicine composition for treating radiation enteritis, a suppository and a preparation method and application thereof. The traditional Chinese medicine composition for treating radiation enteritis comprises the following components in parts by weight: 6-15 parts of pseudo-ginseng powder, 6-15 parts of rhizoma bletillae, 1-7 parts of dragon's blood, 1-5 parts of calculus bovis factitius, 6-15 parts of pearl powder, 6-15 parts of dried ginger charcoal, 6-15 parts of rheum officinale charcoal, 20-50 parts of dandelion, 20-50 parts of sophora flower, 10-30 parts of coptis chinensis and 30-80 parts of honey. The traditional Chinese medicine composition can clear away heat and toxic materials, cool blood, stop bleeding, promote tissue regeneration and heal sores, is prepared into an external preparation, and can effectively treat 1-3 level radiation enteritis through external application of the traditional Chinese medicine composition for clearing away heat and toxic materials and promoting tissue regeneration and heal sores. Compared with oral traditional Chinese medicines, the external medicine disclosed by the invention has the advantages that the first-pass effect of the liver is avoided by intestinal administration, and the utilization efficiency of the medicine is improved. The suppository is used instead of traditional enema, so that the contact time between the traditional Chinese medicine and the diseased region of the intestinal tract is prolonged, and the curative effect of the traditional Chinese medicine can be better exerted.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition and suppository for treating radiation enteritis, and a preparation method and application thereof. Background Art

[0002] Radiation enteritis is a common complication of radiotherapy for malignant tumors, which seriously affects the patient's prognosis and quality of life. Up to 80% of patients who have undergone pelvic radiotherapy will experience acute radiation enteritis, and 50% of patients will develop chronic radiation enteritis. At present, modern medicine mainly treats radiation enteritis with symptomatic treatment, such as nutritional support, endoscopic and surgical treatment, hyperbaric oxygen therapy, enema, fecal microbiota transplantation, etc. Previous research results show that the efficacy of conventional Western medicine treatment of mesalazine anal plug in the treatment of radiation enteritis is 66%. Li Xutong et al. (Li Xutong, Liu Yang, Zhou Mi. The preventive value of probiotics in the occurrence of acute radiation enteritis in patients with gynecological tumors [J]. Modern Medicine, 2023, 51(06): 765-769) found that probiotics can prevent the occurrence of radiation enteritis to a certain extent, but it is not used for treatment; symptomatic treatment drugs such as dexamethasone and pit viper thrombin have many adverse reactions, are prone to recurrence, and cannot be completely cured. Long-term western medicine treatment may not only cause adverse reactions in terms of physical symptoms, but also increase the psychological burden on patients and reduce treatment compliance. In addition, radiation enteritis will also limit the choice of radiotherapy dose and affect the patient's prognosis. Summary of the invention

[0003] In view of the above technical problems, one object of the present invention is to provide a new Chinese medicine composition, which can effectively treat grade 1-3 radiation enteritis.

[0004] Another object of the present invention is to provide the use of the above-mentioned Chinese medicine composition in the preparation of a medicine for treating radiation enteritis.

[0005] Another object of the present invention is to provide a suppository for treating radiation enteritis comprising the above-mentioned Chinese medicine composition, and its preparation and use.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating radiation enteritis. The raw materials of the traditional Chinese medicine composition include, by weight: 6-15 parts of Panax notoginseng powder, 6-15 parts of Bletilla striata, 1-7 parts of Sanguisorba officinalis, 1-5 parts of artificial bezoar, 6-15 parts of pearl powder, 6-15 parts of dried ginger charcoal, 6-15 parts of rhubarb charcoal, 20-50 parts of dandelion, 20-50 parts of Sophora japonica flower, 10-30 parts of Coptis chinensis, and 30-80 parts of honey.

[0008] In the present invention, coptis root is the main drug, flos sophorae, artificial bezoar, pearl powder, notoginseng powder, bletilla striata, blood clotting, dandelion, rhubarb charcoal are the ministerial drugs, dried ginger charcoal is the adjuvant, and honey is the messenger drug. As the main drug, coptis root has the effect of clearing away heat and detoxicating, and bitter cold can dry dampness and strengthen yin, protect the yin fluid in the body, and is assisted by dandelion, artificial bezoar, and pearl powder to play the effect of clearing heat and detoxicating, and the heat toxicity of radiation is discharged; rhubarb charcoal and flos sophorae cool blood and stop bleeding, and are assisted by dried ginger charcoal to prevent the prescription from being too cold and refusing medicine; notoginseng powder promotes tissue regeneration and hemostasis, and is assisted by the astringency of bletilla striata and blood clotting, and the power of hemostasis is strong, and the disadvantage of blood stasis is removed. Honey has the merit of nourishing the middle and moistening dryness, and has the effect of astringency at the same time, which can increase the fit and action time of the drug to the intestinal tract.

[0009] Exemplarily, in parts by weight, the raw materials of the traditional Chinese medicine composition for treating radiation enteritis include: 10 parts of Panax notoginseng powder, 10 parts of Bletilla striata, 3.3 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 10 parts of pearl powder, 10 parts of dried ginger charcoal, 10 parts of rhubarb charcoal, 40 parts of dandelion, 40 parts of Sophora japonica flower, 20 parts of Coptis chinensis, and 40 parts of honey.

[0010] Exemplarily, in parts by weight, the raw materials of the traditional Chinese medicine composition for treating radiation enteritis include: 6 parts of Panax notoginseng powder, 6 parts of Bletilla striata, 2 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 7 parts of pearl powder, 6 parts of dried ginger charcoal, 6 parts of rhubarb charcoal, 30 parts of dandelion, 30 parts of Sophora japonica flower, 20 parts of Coptis chinensis, and 30 parts of honey.

[0011] The basic formula of each raw material medicine of the above-mentioned Chinese medicine composition of the present invention can be adjusted according to clinical symptoms on the basis of the above-mentioned Chinese medicine composition in a specific embodiment to achieve the purpose of treating radiation enteritis and improving certain special clinical symptoms, further enhance the adaptability of the composition of the present invention, and improve the therapeutic effect. These adjustments made based on the basic formula of the present invention are also within the protection scope of this application.

[0012] In a second aspect, the present invention provides use of the above-mentioned Chinese medicine composition in the preparation of a medicine for treating radiation enteritis.

[0013] Further, the Chinese medicine composition of the present invention can be prepared according to conventional preparation methods in the art, such as decoction, immersion, reflux, etc., and then made into various Chinese medicine dosage forms. Optionally, according to the actual preparation molding needs, pharmaceutically acceptable excipients can also be added during preparation. According to the principle of medicine reaching the disease, the drug dosage form of the present invention is preferably an external preparation, including but not limited to ointment, gel or suppository. It can be used externally to clear away heat and detoxify, promote tissue regeneration and heal sores to treat grade 1-3 radiation enteritis.

[0014] In a third aspect, the present invention provides a suppository for treating radiation enteritis, which uses the above-mentioned Chinese medicine composition as an active ingredient.

[0015] Furthermore, the raw materials of the suppository include: 6-15 parts of Panax notoginseng powder, 6-15 parts of Bletilla striata, 1-7 parts of Sanguisorba officinalis, 1-5 parts of artificial bezoar, 6-15 parts of pearl powder, 6-15 parts of dried ginger charcoal, 6-15 parts of rhubarb charcoal, 20-50 parts of dandelion, 20-50 parts of Sophora japonica flower, 10-30 parts of Coptis chinensis, 30-80 parts of honey, and 100-160 parts of mixed fatty acid glycerides.

[0016] Exemplarily, the raw materials of the suppository include: 10 parts of Panax notoginseng powder, 10 parts of Bletilla striata, 3.3 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 10 parts of pearl powder, 10 parts of dried ginger charcoal, 10 parts of rhubarb charcoal, 40 parts of dandelion, 40 parts of Sophora japonica flower, 20 parts of Coptis chinensis, 40 parts of honey, and 140 parts of mixed fatty acid glycerides.

[0017] Exemplarily, the raw materials of the suppository include: 6 parts of Panax notoginseng powder, 6 parts of Bletilla striata, 2 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 7 parts of pearl powder, 6 parts of dried ginger charcoal, 6 parts of rhubarb charcoal, 30 parts of dandelion, 30 parts of Sophora japonica flower, 20 parts of Coptis chinensis, 30 parts of honey, and 100 parts of mixed fatty acid glycerides.

[0018] The present invention also provides a method for preparing the suppository for treating radiation enteritis, which comprises the following steps:

[0019] Take Sophora japonica, Coptis chinensis and Taraxacum officinale, add water and decoct twice, add 8-10 times of water for the first time, add 6-8 times of water for the second time, decoct for 1-2 hours each time, filter, and combine the filtrate; concentrate the filtrate at 70°C and vacuum degree ≥-0.08Mpa to an extract with a relative density of 1.05-1.10; dry the extract under reduced pressure, crush it, and pass it through an 80-mesh sieve to obtain a dry paste powder;

[0020] Take Bletilla striata, Dragon's blood, Rhubarb charcoal and Dried ginger charcoal respectively, grind them, pass through 80 mesh sieve to obtain Bletilla striata powder, Dragon's blood powder, Rhubarb charcoal powder and Dried ginger charcoal powder;

[0021] Take the dry paste powder, white twig powder, dragon's blood powder, rhubarb charcoal powder, and dried ginger charcoal powder prepared by the above method, add pearl powder, notoginseng powder, and artificial bezoar, and mix evenly to prepare a mixed medicine powder;

[0022] Take honey, heat it at 120℃, stir it constantly while heating, and stop heating when the water loss reaches 7-9%, and obtain refined honey;

[0023] Take refined honey and mixed fatty acid glycerides, heat to 80℃ to melt, stir evenly, add mixed medicinal powder, continue to stir evenly, then pour into a mold, cool and shape, take out the contents, and you have it.

[0024] In the suppository of the present invention, the sweet taste of honey can relieve and replenish, relieve abdominal pain caused by cramps, and replenish damaged qi and blood. In addition, honey is used as an excipient to increase the adhesion of the drug to the intestine and the duration of action.

[0025] The suppository prepared by the invention has good formability, has no change in shape at room temperature in summer, has no irritation to mucosal tissues, and has no toxic or side effects.

[0026] In addition, unless otherwise specified, each raw material of the Chinese medicine composition of the present invention can be obtained from commercial sources or prepared by known methods. Any range of Chinese medicine compositions recorded in the present invention including the end value and any value between the end values ​​and any sub-range formed by the end value or any value between the end values ​​can achieve the purpose of treating radiation enteritis.

[0027] The beneficial effects of the present invention are as follows:

[0028] In view of the characteristics of radiation enteritis, which is characterized by raging fire poison and damage to the intestines and viscera, the Chinese medicine composition of the present invention can clear away heat and detoxify, cool blood and stop bleeding, promote tissue regeneration and heal sores. It is made into an external preparation, and external anal application can effectively treat grade 1-3 radiation enteritis by clearing heat and detoxifying, promoting tissue regeneration and heal. Compared with oral Chinese medicine, the external medicine of the present invention avoids the "first-pass effect" of the liver in intestinal administration, and improves the utilization efficiency of the medicine. Using suppositories instead of traditional enema, compared with traditional Chinese medicine retention enema, suppositories increase the contact time between Chinese medicine and intestinal lesions, and can better exert the efficacy of Chinese medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 The number of people with different types of stools before and after treatment is shown. DETAILED DESCRIPTION

[0030] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments and drawings. It should be understood by those skilled in the art that the content described below is illustrative rather than restrictive, and should not be used to limit the scope of protection of the present invention.

[0031] Example 1 A suppository for treating radiation enteritis

[0032] Raw material formula: Panax notoginseng powder 10g, Bletilla striata 10g, Sanguisorba officinalis 3.3g, artificial bezoar 1g, pearl powder 10g, dried ginger charcoal 10g, rhubarb charcoal 10g, dandelion 40g, Sophora japonica flower 40g, Coptis chinensis 20g, honey 40g, mixed fatty acid glyceride 140g (for making 200 suppositories).

[0033] Preparation method:

[0034] Take Sophora japonica, Coptis chinensis and Taraxacum officinale, add water and decoct twice, add 8 times of water for the first time and 6 times of water for the second time, decoct for 1 hour each time, filter and combine the filtrate; concentrate the filtrate at 70°C and vacuum degree ≥-0.08Mpa to an extract (70°C) with a relative density of 1.05-1.10; dry the extract under reduced pressure, crush it, and pass it through an 80-mesh sieve to obtain a dry paste powder;

[0035] Take Bletilla striata, Dragon's blood, Rhubarb charcoal and Dried ginger charcoal respectively, grind them, pass through 80 mesh sieve to obtain Bletilla striata powder, Dragon's blood powder, Rhubarb charcoal powder and Dried ginger charcoal powder;

[0036] Take the dry paste powder, white twig powder, dragon's blood powder, rhubarb charcoal powder, and dried ginger charcoal powder prepared by the above method, add pearl powder, notoginseng powder, and artificial bezoar, and mix evenly to prepare a mixed medicine powder;

[0037] Take honey, heat it at 120℃, stir it constantly while heating, and stop heating when the water loss reaches 7-9%, and obtain refined honey;

[0038] Take refined honey and mixed fatty acid glycerides, heat to 80℃ to melt, stir evenly, add mixed medicinal powder, continue to stir evenly, then pour into a mold, cool and shape, take out the contents, and you have it.

[0039] Example 2 A suppository for treating radiation enteritis

[0040] Raw material formula: Panax notoginseng powder 6g, Bletilla striata 6g, Sanguisorba officinalis 2g, artificial bezoar 1g, pearl powder 7g, dried ginger charcoal 6g, rhubarb charcoal 6g, dandelion 30g, Sophora japonica flower 30g, Coptis chinensis 20g, honey 30g, mixed fatty acid glyceride 100g (for making 120 suppositories).

[0041] Preparation method:

[0042] Take Sophora japonica, Coptis chinensis and Taraxacum officinale, add water and decoct twice, add 8 times of water for the first time and 6 times of water for the second time, decoct for 1 hour each time, filter and combine the filtrate; concentrate the filtrate at 70°C and vacuum degree ≥-0.08Mpa to an extract (70°C) with a relative density of 1.05-1.10; dry the extract under reduced pressure, crush it, and pass it through an 80-mesh sieve to obtain a dry paste powder;

[0043] Take Bletilla striata, Dragon's blood, Rhubarb charcoal and Dried ginger charcoal respectively, grind them, pass through 80 mesh sieve to obtain Bletilla striata powder, Dragon's blood powder, Rhubarb charcoal powder and Dried ginger charcoal powder;

[0044] Take the dry paste powder, white twig powder, dragon's blood powder, rhubarb charcoal powder, and dried ginger charcoal powder prepared by the above method, add pearl powder, notoginseng powder, and artificial bezoar, and mix evenly to prepare a mixed medicine powder;

[0045] Take honey, heat it at 120℃, stir it constantly while heating, and stop heating when the water loss reaches 7-9%, and obtain refined honey;

[0046] Take refined honey and mixed fatty acid glycerides, heat to 80℃ to melt, stir evenly, add mixed medicinal powder, continue to stir evenly, then pour into a mold, cool and shape, take out the contents, and you have it.

[0047] Example 3 Clinical Trial

[0048] 1 Treatment and methods

[0049] 1.1 Inclusion and exclusion standards:

[0050] Inclusion criteria: (1) Patients with a clear diagnosis of abdominal and pelvic malignant tumors by pathology or cytology; (2) Patients without tumors after surgery: patients with CR as evaluated by imaging after surgery or chemoradiotherapy. (3) Patients who have received radiotherapy; (4) Patients diagnosed with grade 1-3 radiation enteritis according to the acute radiation injury grading criteria and the European Organization for Research on the Treatment of Cancer (RTOG / EORTC) acute radiation injury grading criteria; (5) Age range 18-75 years; (6) Expected survival time > 6 months, without severe liver and kidney damage and other major systemic diseases; (7) Voluntary participation, good compliance, family members informed, and signed informed consent for treatment.

[0051] Exclusion criteria: (1) patients undergoing radiotherapy; (2) patients who are pregnant or breastfeeding, or have mental illness or allergic constitution; (3) patients with severe liver and kidney damage or other major systemic diseases; (4) patients with a history of gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, or irritable bowel syndrome); (5) patients with previous intestinal surgery, intestinal obstruction, or intestinal perforation; (6) patients who have participated in other clinical or drug trials in the past 3 months; (7) patients with poor compliance or refusal to sign the informed consent for treatment.

[0052] 1.2 Clinical Data

[0053] Thirty patients with radiation enteritis who visited the Department of Oncology of our hospital from March 2023 to March 2024 were selected as the research subjects. All were female, aged 40 to 64 years old, with an average age of 55.57±7.09 years old; average height of 1.59±0.59 meters; average weight of 58.40±9.32kg, and average BMI of 23.02±3.46kg / m 2 The primary tumor types included cervical cancer in 25 cases, ovarian cancer in 2 cases, endometrial cancer in 2 cases, and vulvar cancer in 1 case.

[0054] 1.3 Treatment methods

[0055] Intervention measures: Changkang suppository (suppository prepared in Example 1 of the present invention) was placed in the rectum for treatment. The treatment cycle was 2 cycles, each cycle lasting 7 days, for a total of 14 days.

[0056] How to use Changkang suppository: ① Go to the toilet before using the suppository; ② Use a booster to insert the suppository into the anus, with the depth of insertion being 10-15cm from the anus; ③ To facilitate the insertion of the suppository, it can be soaked with water or cream; ④ If the suppository flows out within ten minutes, another suppository needs to be inserted.

[0057] 1.4 Observation indicators

[0058] (1) Grading of intestinal reactions;

[0059] (2) Health status: using the KPS scale;

[0060] (3) TCM symptom score;

[0061] (4) Stool characteristics and blood in stool.

[0062] 1.5 Statistical analysis

[0063] The data were analyzed using SPSS 25.0 software. Count data were expressed as percentages (%) and compared using χ 2 Test or nonparametric test; measurement data were expressed as mean ± standard deviation Paired sample t test or nonparametric test was used for comparison. P < 0.05 indicated that the difference was statistically significant.

[0064] 2. Results

[0065] 2.1 Changes in the intestinal reaction scoring standard (RTOG / EORTC) before and after treatment

[0066] An analysis of the intestinal reaction grading of 30 patients with radiation enteritis before and after treatment found that after 2 cycles (14 days) of rectal treatment with Changkang suppository, the intestinal reaction grading level of the patients decreased, P=0.004, and the difference was statistically significant.

[0067] Table 1 Grades of intestinal reactions in patients with radiation enteritis before and after treatment

[0068]

[0069] A before-and-after analysis of 30 patients found that before treatment, there were 18 patients with grade 2-3 intestinal reactions, but after treatment, there were only 7 patients with grade 2-3 reactions, and 6 of them had their intestinal reaction scores dropped to grade 0.

[0070] 2.2 Changes in quality of life before and after treatment

[0071] The quality of life (KPS score) of 30 patients before and after treatment was evaluated. As shown in the following table, the average KPS score of patients before treatment was 79.33 points, and the average KPS score after treatment was 87 points, an increase of 7.67 points, P = 0.001, which was statistically significant before and after treatment. See Table 2 for details.

[0072] Table 2 Evaluation of quality of life scores

[0073]

[0074] 2.3 Comparison of TCM symptom scores

[0075] The TCM symptoms of 30 patients before and after treatment are evaluated as shown in the following table. After treatment, the TCM symptom scores of 9 symptoms such as abdominal distension, abdominal pain, and difficulty in defecation decreased, indicating that the intestinal symptoms improved after medication. Among them, the symptoms of bloody stool and mucus in stool improved significantly, and the statistical analysis showed that P < 0.05, and the difference was statistically significant, as shown in Table 3.

[0076] Table 3 Changes in TCM symptom scores before and after treatment

[0077]

[0078] 2.4 Changes in stool shape

[0079] The Bristol stool classification method was used to analyze the changes in stool shape before and after treatment. Figure 1 As shown. The stool shape was divided into three categories, namely dry stool (type 1-2), ideal stool (type 3-4) and loose stool (type 5-7). After treatment with Changkang suppository anus, the number of people with ideal stool shape increased from 7 (23.3%) to 15 (50.0%). P = 0.06, although the difference was not statistically significant, there was a trend of stool shape tending to normal values ​​(Table 4).

[0080] Table 4 Comparison of the number of ideal bowel movements before and after treatment

[0081]

[0082] 2.5 Frequency of bowel movements and blood in stool

[0083] According to the modified Mayo scoring system, the normal bowel movement frequency was set as 0 points, the increase of 1-2 times / day over the normal bowel movement frequency was set as 1 point, the increase of 3-4 times / day over the normal bowel movement frequency was set as 2 points, and the increase of ≥5 times / day over the normal bowel movement frequency was set as 3 points. As shown in Table 5, after 14 days of rectal treatment with Changkang suppository, the patient's bowel movement frequency was significantly reduced compared with before, P < 0.001, and the difference was statistically significant.

[0084] Table 5 Changes in bowel movement frequency before and after treatment

[0085]

[0086] No bleeding was set as 0 points, blood mixed in stool less than half of the time was set as 1 point, blood mixed in stool most of the time was set as 2 points, and bleeding all the time was set as 3 points. As shown in Table 6, after 14 days of rectal treatment with Changkang suppository, the patient's stool bleeding was significantly reduced compared with before, P = 0.031, and the difference was statistically significant.

[0087] Table 6 Changes of blood in stool before and after treatment

[0088]

[0089] 3. Conclusion

[0090] After treatment, the intestinal reaction grade and quality of life of the patients were significantly improved, the stool shape was closer to the ideal stool, and the symptoms of stool bleeding, stool frequency, stool mucus, tenesmus, etc. were all improved. This shows that the Changkang suppository of the present invention has a good effect on improving radiation enteritis.

[0091] Example 4 Typical Cases

[0092] Typical case 1: Cheng, female, 64 years old. Diagnosed with cervical cancer in May 2022. After diagnosis, 28 radiotherapy sessions and 6 afterloading therapy sessions were performed, in conjunction with chemotherapy (scheme unknown). In March 2023, she was admitted to our outpatient clinic. The intestinal reaction was graded as grade 3. The number of daily bowel movements in the past three days increased by ≥5 times / day compared to the normal number of bowel movements. There was always bleeding in the stool. According to the Bristol scale, the stool characteristics were close to type 6. At the same time, there were typical symptoms of radiation enteritis such as abdominal distension, mucus, pus and blood in the stool, tenesmus, and anal swelling, with a KPS score of 70 points. After 14 days of anal treatment with Changkang suppository (Example 1), the patient's intestinal reaction grade was reduced to grade 1, the number of daily bowel movements increased by 1-2 times / day compared with the normal number, and in the past 3 days, only less than half of the time was there was blood in the stool, and according to the Bristol scale, the stool characteristics were close to type 4 (ideal stool), and the patient's abdominal distension, mucus, pus and blood in the stool, tenesmus and other symptoms were significantly improved compared with before, and the abdominal distension and anal distension disappeared, and the KPS score was 90 points. The patient was followed up after discontinuation of the drug, and the patient's symptoms did not recur.

[0093] Typical case 2: Li, female, 42 years old. Diagnosed with cervical cancer in December 2021, she received 25 radiotherapy sessions after surgery and chemotherapy (unknown regimen). She was treated in our outpatient clinic in February 2023. The intestinal reaction was graded as level 3. The number of daily bowel movements in the past 3 days increased by ≥5 times / day compared to the normal number of bowel movements. There was always bleeding in the stool. According to the Bristol scale, the stool characteristics were close to type 7. It was accompanied by typical symptoms of radiation enteritis such as abdominal distension, mucus, pus and blood in the stool, tenesmus, and anal swelling, with a KPS score of 70 points. After 14 days of anal treatment with Changkang suppository (Example 1), the patient's intestinal reaction grade was reduced to level 1, the number of bowel movements was normal, and the symptoms of bleeding in the stool disappeared in the past 3 days. According to the Bristol scale, the stool characteristics were close to type 4 (ideal stool). The patient's symptoms such as pus, blood in the stool, tenesmus, and anal swelling were significantly improved compared to before, and the symptoms such as loose stools and mucus in the stool disappeared, with a KPS score of 90 points. The patient was followed up after medication was discontinued and no recurrence of symptoms was observed.

[0094] Typical case 3: Wang, female, 52 years old. The patient was diagnosed with cervical cancer in December 2021. Radiotherapy and afterloading therapy were performed after surgery, and chemotherapy (scheme unknown). In February 2023, she was admitted to our outpatient clinic. The intestinal reaction was graded as grade 2. The number of bowel movements per day increased by ≥3-4 times / day compared with the normal number of bowel movements. In the past 3 days, less than half of the stools were mixed with blood. According to the Bristol scale, the stool characteristics were close to type 6. At the same time, there were typical symptoms of radiation enteritis such as abdominal distension, mucus, pus and blood in the stool, tenesmus, and anal swelling, with a KPS score of 80 points. After 14 days of anal treatment with Changkang suppository (Example 1), the patient's intestinal reaction grade was reduced to grade 1, the number of daily bowel movements increased by ≥1-2 times / day compared with the normal number of bowel movements, and there was no bleeding in the stool in the past 3 days. According to the Bristol scale, the stool characteristics were close to type 5. The patient's symptoms such as loose stools, tenesmus, and anal swelling were significantly improved compared with before, and the symptoms such as bleeding in the stool and mucus in the stool disappeared, and the KPS score was 100. The patient was followed up after discontinuation of the drug, and the patient's symptoms did not recur.

[0095] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not limitations on the implementation methods of the present invention. For ordinary technicians in the relevant field, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation methods here. All obvious changes or modifications derived from the technical solution of the present invention are still within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating radiation enteritis, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition include: 6-15 parts of Panax notoginseng powder, 6-15 parts of Bletilla striata, 1-7 parts of Sanguisorba officinalis, 1-5 parts of artificial bezoars, 6-15 parts of pearl powder, 6-15 parts of dried ginger charcoal, 6-15 parts of rhubarb charcoal, 20-50 parts of dandelion, 20-50 parts of Sophora japonica flower, 10-30 parts of Coptis chinensis, and 30-80 parts of honey.

2. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition include: 10 parts of Panax notoginseng powder, 10 parts of Bletilla striata, 3.3 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 10 parts of pearl powder, 10 parts of dried ginger charcoal, 10 parts of rhubarb charcoal, 40 parts of dandelion, 40 parts of Sophora japonica flower, 20 parts of Coptis chinensis, and 40 parts of honey.

3. The Chinese medicine composition according to claim 1, characterized in that In terms of weight, the raw materials of the traditional Chinese medicine composition include: 6 parts of Panax notoginseng powder, 6 parts of Bletilla striata, 2 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 7 parts of pearl powder, 6 parts of dried ginger charcoal, 6 parts of rhubarb charcoal, 30 parts of dandelion, 30 parts of Sophora japonica flower, 20 parts of Coptis chinensis, and 30 parts of honey.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating radiation enteritis.

5. The use according to claim 4, characterized in that: The dosage form of the drug includes ointment, gel or suppository.

6. A suppository for treating radiation enteritis, characterized in that: The Chinese medicine composition according to any one of claims 1 to 3 is used as the active ingredient.

7. The suppository according to claim 6, characterized in that The raw materials of the suppository include: 6-15 parts of Panax notoginseng powder, 6-15 parts of Bletilla striata, 1-7 parts of Sanguisorba officinalis, 1-5 parts of artificial bezoar, 6-15 parts of pearl powder, 6-15 parts of dried ginger charcoal, 6-15 parts of rhubarb charcoal, 20-50 parts of dandelion, 20-50 parts of Sophora japonica flower, 10-30 parts of Coptis chinensis, 30-80 parts of honey, and 100-160 parts of mixed fatty acid glyceride; Preferably, the raw materials of the suppository include: 10 parts of Panax notoginseng powder, 10 parts of Bletilla striata, 3.3 parts of Dragon's blood, 1 part of artificial bezoar, 10 parts of pearl powder, 10 parts of dried ginger charcoal, 10 parts of rhubarb charcoal, 40 parts of dandelion, 40 parts of Sophora japonica flower, 20 parts of Coptis chinensis, 40 parts of honey, and 140 parts of mixed fatty acid glycerides; Preferably, the raw materials of the suppository include: 6 parts of Panax notoginseng powder, 6 parts of Bletilla striata, 2 parts of Sanguisorba officinalis, 1 part of artificial bezoar, 7 parts of pearl powder, 6 parts of dried ginger charcoal, 6 parts of rhubarb charcoal, 30 parts of dandelion, 30 parts of Sophora japonica flower, 20 parts of Coptis chinensis, 30 parts of honey, and 100 parts of mixed fatty acid glycerides.

8. The method for preparing the suppository for treating radiation enteritis according to claim 6 or 7, characterized in that: The following steps are involved: Take Sophora japonica, Coptis chinensis and Taraxacum officinale, add water and decoct twice, add 8-10 times of water for the first time, add 6-8 times of water for the second time, decoct for 1-2 hours each time, filter, and combine the filtrate; concentrate the filtrate at 70°C and vacuum degree ≥-0.08Mpa to an extract with a relative density of 1.05-1.10; dry the extract under reduced pressure, crush it, and pass it through an 80-mesh sieve to obtain a dry paste powder; Take Bletilla striata, Dragon's blood, Rhubarb charcoal and Dried ginger charcoal respectively, grind them, pass through 80 mesh sieve to obtain Bletilla striata powder, Dragon's blood powder, Rhubarb charcoal powder and Dried ginger charcoal powder; Take the dry paste powder, white twig powder, dragon's blood powder, rhubarb charcoal powder, and dried ginger charcoal powder prepared by the above method, add pearl powder, notoginseng powder, and artificial bezoar, and mix evenly to prepare a mixed medicine powder; Take honey, heat it at 120℃, stir it constantly while heating, and stop heating when the water loss reaches 7-9%, and obtain refined honey; Take refined honey and mixed fatty acid glycerides, heat to 80℃ to melt, stir evenly, add mixed medicinal powder, continue to stir evenly, then pour into a mold, cool and shape, take out the contents, and you have it.

9. Use of the suppository according to claim 6 or 7 in the preparation of a medicament for treating radiation enteritis.

10. The use according to claim 4 or 9, characterized in that: The radiation enteritis is grade 1-3 radiation enteritis.

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