A Chinese medicine composition for preventing and treating radiation pneumonia and its application

Abstract

The invention discloses a Chinese medicine composition for preventing and treating radiation pneumonia, which is prepared from the following Chinese medicinal materials in weight ratio: 10-20 parts of Sanguisorba officinalis, 10-14 parts of Radix Paeoniae Rubra, 10-20 parts of Radix Astragali, 10-14 parts of Atractylodes macrocephala, 10-20 parts of Radix Ophiopogonis, 10-20 parts of Fagopyrum scabra, and 10-20 parts of Cortex Mori. The Chinese medicine composition "Qingyi Hufei Fang" of the invention has the effect of preventing and treating radiation pneumonia, has good therapeutic effect, is safe and reliable, adopts Chinese medicine, and the raw materials are easy to obtain, and discloses a preparation method and application thereof.

Description

Technical Field

[0001] The invention relates to the field of medicine, and in particular to a traditional Chinese medicine composition for preventing and treating radiation pneumonia and application thereof. Background Art

[0002] Radiation pneumonia (RP) is a common complication of radiotherapy for malignant thoracic tumors such as lung cancer, breast cancer, esophageal cancer, and mediastinal tumors. Radiation pneumonia is the acute injury stage of radiation-related lung injury, which usually occurs within 6 months after treatment (usually within 12 weeks). Excluding lung diseases such as tumor progression, chronic obstructive pulmonary disease, and bacterial pneumonia, the diagnosis can be made if the symptoms are mainly cough, chest pain, shortness of breath, or fever, and imaging manifestations are patchy shadows and pulmonary consolidation shadows confined to the radiation field. At present, modern medicine mainly treats RP with symptomatic treatments such as antibiotics and glucocorticoids, but it is easy to cause many side effects such as superinfection, dysbacteriosis, and immunosuppression, and the overall effect is poor.

[0003] RP belongs to the category of diseases such as "pulmonary emphysema", "cough", "asthma", and "pulmonary paralysis" in traditional Chinese medicine. "Wai Tai Mi Yao·Cough Chapter" says: "Lung cough for a long time will lead to pulmonary emphysema, and its symptoms are not limited to the cold and heat of the four seasons." "Jingui Yaolue" says: "If the heat is in the upper part of the body, coughing will cause pulmonary emphysema." Li Yongcui of the Qing Dynasty said in "Zhengzhi Huibu·Xiangdiamen Chapter" that "Long-term cough means lung deficiency, alternating cold and heat... rapid and weak pulse is a disease of pulmonary emphysema. Due to the loss of body fluids, the fire is burning and the metal is dry, just like the branches and leaves of plants wither due to drought." The "pulmonary emphysema" mentioned above is similar to RP. In the prevention and treatment of radiation pneumonia, most doctors believe that the pathogenesis is nothing more than the two aspects of deficiency and excess, and qi and blood. Traditional Chinese medicine uses syndrome differentiation and treatment. According to the characteristics of the disease and clinical symptoms, the treatment is often based on the treatment of clearing heat and detoxification, invigorating qi and nourishing yin, and promoting blood circulation and removing blood stasis. After years of clinical observation, Professor Wu found that radiation, as a kind of hot and toxic evil, invades the body and does not follow the process of Wei Qi Ying Xue transmission and transformation. It often enters the stage of viscera Ying Xue, consuming qi, blood and body fluids. Combined with the fact that tumor patients have long-term stasis and are affected by hot and toxic evil, stasis and heat are combined, resulting in the body's qi and yin deficiency, stasis and heat, and symptoms such as fever and irritability, red tongue and ecchymosis, fatigue, lack of breath and laziness, cough and dry throat, dry stool, red tongue and less coating, etc. Therefore, the treatment is to cool the blood and disperse stasis, invigorate qi and nourish yin, and at the same time assist with clearing the lungs and removing phlegm.

[0004] Therefore, it is of great significance to combine traditional Chinese medicine hospitals with modern preparation technology to research and develop a Chinese medicine compound preparation for the treatment of RP, and it also has huge market development potential. Summary of the invention

[0005] The invention provides a Chinese medicine composition for preventing and treating radiation pneumonia with significant efficacy and small side effects and a preparation method thereof, which has significant efficacy and solves the technical problems of the existing treatment being difficult and the poor effect of western medicine.

[0006] In order to achieve the above purpose, the present invention adopts the following technical scheme: a traditional Chinese medicine composition for preventing and treating radiation pneumonia, which is prepared from the following raw materials in parts by weight: 10-20 parts of Sanguisorba officinalis, 10-14 parts of Red Peony Root, 10-20 parts of Astragalus, 10-14 parts of Atractylodes Macrocephala, 10-20 parts of Ophiopogon japonicus, 10-20 parts of Fagopyrum scabra, and 10-20 parts of Morus alba.

[0007] The traditional Chinese medicine composition for preventing and treating radiation pneumonia is prepared from the following raw materials in parts by weight: 15 parts of Sanguisorba officinalis, 12 parts of Radix Paeoniae Rubra, 15 parts of Radix Astragali, 12 parts of Atractylodes macrocephala, 15 parts of Radix Ophiopogonis, 15 parts of Fagopyrum scabra, and 15 parts of Cortex Mori.

[0008] In the traditional Chinese medicine composition for preventing and treating radiation pneumonia, the Sanguisorba officinalis is raw Sanguisorba officinalis, the Astragalus membranaceus is roasted Astragalus membranaceus, and the Atractylodes macrocephala is stir-fried Atractylodes macrocephala.

[0009] The preparation method of the traditional Chinese medicine composition for preventing and treating radiation pneumonia comprises the following steps: weighing the above medicinal materials according to the dosage, adding 10-20 times the weight of water, soaking for 3 hours, heating to boiling, decocting twice, each time for 2-3 hours, combining the decoctions, filtering, evaporating and concentrating, adding 1.5 times the amount of ethanol after cooling, fully mixing, leaving overnight, taking the supernatant, washing the precipitate with a small amount of 50% ethanol, combining the washing liquid with the filtrate, recovering the ethanol under reduced pressure, concentrating, cooling and standing, filtering, vacuum low-temperature concentrating to a thick paste, spray drying, passing through a 300-mesh sieve, adding appropriate amounts of auxiliary materials and preparing the preparation.

[0010] The Chinese medicine composition for preventing and treating radiation pneumonia is in the form of granules, tablets, capsules, powders, pills or paste prescriptions.

[0011] The preparation method of the Chinese medicine composition for preventing and treating radiation pneumonia comprises the following steps: weighing the above medicinal materials according to the dosage, adding 10-20 times the weight of water, soaking for 3 hours, heating to boiling, decocting twice, each time for 2-3 hours, combining the decoctions, filtering, evaporating and concentrating, and cooling to obtain a decoction or oral solution.

[0012] Application of the traditional Chinese medicine composition for preventing and treating radiation pneumonia in preparing medicine for preventing and treating radiation pneumonia.

[0013] Raw Sanguisorba officinalis: This product is the dried root of Sanguisorba officinalis L. or Sanguisorba officinalis L.var.longifolia (Bert.) Yüet Li, a plant of the Rosaceae family. It tastes bitter, sour, astringent, and slightly cold. It enters the liver and large intestine meridians. It cools blood and stops bleeding, detoxifies and heals sores. It is used for blood in stool, hemorrhoids, bloody diarrhea, metrorrhagia, burns caused by water or fire, carbuncle, sore and poison. Tannins, saponins, flavonoids, polysaccharides, etc. Some active substances have been developed for anti-inflammatory, antibacterial, anti-tumor, hemostasis and immune enhancement.

[0014] Red peony root: This product is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch, a plant of the Ranunculaceae family. It tastes bitter and slightly cold. It enters the liver meridian. It clears away heat and cools blood, dissipates blood stasis and relieves pain. It is used for fever-induced rashes, vomiting blood, epistaxis, red eyes and tumors, liver depression and hypochondrium pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, carbuncles and ulcers. Paeoniflorin can inhibit proinflammatory mediators, significantly reduce platelet and red blood cell aggregation, enhance red blood cell deformability, prolong prothrombin time, activate partial prothrombin time, reduce whole blood viscosity and plasma viscosity under high and low shear rates, and thus reduce thrombus formation.

[0015] Fagopyrum dibotrys (D. Don) Hara: This product is the dried rhizome of Fagopyrum dibotrys (D. Don) Hara, a plant of the Polygonaceae family. It is slightly pungent, astringent, and cool. It enters the lung meridian. It clears away heat and detoxifies, discharges pus and removes blood stasis. It is used for lung abscesses, measles pneumonia, and peritonsillar abscesses, and can significantly improve respiratory inflammation.

[0016] Mulberry bark: This product is the dried root bark of Mirus alba L., a plant of the Moraceae family. Sweet, cold. Enters the lung meridian. It can relieve lung heat and asthma, promote diuresis and reduce swelling. It is used for lung heat, asthma, cough, edema, oliguria, and puffy face and skin. The total flavonoids of Mulberry bark have significant anti-inflammatory effects, and Sanggenone C and Sanggenone O can significantly reduce NO production and nuclear factor-κB (NF-κB) activity.

[0017] Ophiopogon japonicus: This product is the dried root of Ophiopogon japonicus (Thunb.) Ker-Gawl., a plant of the Liliaceae family. It tastes sweet, slightly bitter, and slightly cold. It enters the heart, lung, and stomach meridians. It nourishes yin and produces body fluid, moistens the lungs and clears the heart. It is used for dry cough due to lung dryness, consumptive cough, thirst due to loss of body fluid, restlessness and insomnia, internal heat and thirst, dry intestines and constipation, and diphtheria. The active ingredients of Ophiopogon japonicus and Ophiopogon japonicus have anti-inflammatory, anti-radiation, and antioxidant effects, and have a good protective effect on irradiated lung tissue.

[0018] Roasted Astragalus: This product is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge, a plant of the Leguminosae family. This product is a processed product of Astragalus. Sweet and warm. Enters the lung and spleen meridians. Replenishes qi and nourishes the middle. Used for qi deficiency, fatigue, poor appetite and loose stools. Astragaloside IV, as the main active ingredient of Astragalus, is widely used in clinical practice for its significant effects in improving immunity and anti-inflammatory effects. Astragaloside IV can inhibit the secretion of interleukin-1 and tumor necrosis factor-α by peritoneal macrophages in vitro, reduce the release of inflammatory factors, and thus alleviate inflammatory reactions.

[0019] Stir-fried Atractylodes macrocephala: This product is the dried rhizome of Atractylodes macrocephala Koldz., a plant of the Asteraceae family. It is dug up in winter when the lower leaves turn yellow and the upper leaves become brittle, and the sand is removed, and the roots are dried or sun-dried, and then the fibrous roots are removed. It tastes bitter, sweet, and warm. It enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. It is used for spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid, palpitations, edema, spontaneous sweating, and restless fetuses. Atractylodes macrocephala strengthens the spleen, harmonizes the stomach, and calms the fetus. It is used for spleen deficiency, poor appetite, diarrhea, and restless fetuses. Atractylodes macrocephala lactone components and Atractylodes macrocephala polysaccharides have significant anti-inflammatory activity. Atractylodes macrocephala lactone has the effect of inhibiting platelet aggregation, and Atractylodes macrocephala polysaccharides can reduce the content of TNF-α, IFN-γ, and NO, induce NF-κB activation through p65 nuclear translocation, and regulate the activity of macrophages by activating the NF-κB signaling pathway.

[0020] Beneficial effects:

[0021] The Qingyi Hufei recipe of the present invention is an effective recipe for preventing and treating radiation pneumonia by Professor Wu Mianhua, a nationally famous traditional Chinese medicine doctor. The Qingyi Hufei recipe is composed of 7 herbs: raw sanguisorba officinalis, red peony root, golden buckwheat, white mulberry bark, ophiopogon japonicus, roasted astragalus, stir-fried atractylodes macrocephala and raw licorice. It is modified from Sijunzi decoction, rhinoceros horn and rehmannia decoction and white mulberry bark decoction with additions and subtractions. It has the effects of cooling blood and dispersing blood stasis, invigorating qi and nourishing yin, clearing the lungs and resolving phlegm. It is used for radiation pneumonia caused by blood stasis and heat binding, qi consumption and yin damage, and lung network damage, and the syndrome type is blood stasis and heat burning the lungs and both qi and yin damage syndrome.

[0022] Among them, "stasis and heat" refers to the pathological factors with new characteristics formed by the combination of stasis and heat, which belongs to the concept of pathogenesis in traditional Chinese medicine. Wang Qingren mentioned in "Correcting Errors in Medicine": "The plague poison burns the blood inside, and the blood is burned and refined, so the blood must coagulate", indicating that the combination of blood heat is the pathological basis for the generation of stasis and heat. Blood heat can lead to blood stasis, and blood stasis can turn into blood heat. Stasis and heat are both pathogenic mechanisms and pathological factors. In the process of pathogenicity, not only are stasis and heat involved, but also there is an inherent causal relationship between stasis and heat. Qingyi Hufei Fang is based on the theory of "stasis and heat" and traditional Chinese medicine. It is composed of raw Sanguisorba officinalis and red peony root as the main ingredients, and roasted Astragalus, stir-fried Atractylodes macrocephala and Ophiopogon japonicus as the assistants to nourish yin and benefit qi, and protect the qi. It is assisted by golden buckwheat and mulberry bark to clear the lungs and resolve phlegm, and help the main medicine to cool the blood and disperse blood stasis. The combination of these medicines has the effects of cooling blood and dispersing blood stasis, invigorating qi and nourishing yin, clearing the lungs and resolving phlegm, and has achieved certain clinical and basic research therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The incidence of radiation pneumonia in the clinical cases of the present invention is

[0024] Figure 2 The impact of the clinical cases of the present invention on the TCM clinical syndrome score efficacy rating

[0025] Figure 3The effect of the KPS score on the efficacy rating before and after radiotherapy in the clinical case of the present invention

[0026] Figure 4 It is the effect on the weight of mice in the experimental examples of the present invention;

[0027] Figure 5 This is the effect on the lung coefficient of each group of mice in the experimental example of the present invention.

[0028] Figure 6 The effect of HE staining on mouse lung tissue in the experimental example of the present invention

[0029] Figure 7 It is the effect on the expression of inflammatory factors related to mouse bronchoalveolar lavage fluid in the experimental example of the present invention;

[0030] Figure 8 The present invention affects the expression of HMGB1, p-NF-kB, NF-kB, TLR4, and RAGE-related proteins in RP mice;

[0031] In the above figures, A is the control group, B is the model group, C is the high-dose Chinese medicine group, and D is the glycyrrhizic acid group (i.e., the positive drug control group). DETAILED DESCRIPTION

[0032] The present invention is further described below in conjunction with embodiments, but the present invention is not limited to these specific examples.

[0033] Example 1

[0034] Take 150g of raw Sanguisorba officinalis, 120g of red peony root, 150g of roasted Astragalus membranaceus, 120g of stir-fried Atractylodes macrocephala, 150g of Ophiopogon japonicus, 150g of Fagopyrum scabra, and 150g of Morus alba, mix the medicinal materials, weigh the above medicinal materials according to the amount, add 15 times the weight of water, soak for 3 hours, heat to boiling, decoct twice, each time for 2 hours, combine the decoctions, filter, evaporate and concentrate, and cool to make 2000 ml of decoction.

[0035] Example 2

[0036] Take 100g of raw Sanguisorba officinalis, 140g of red peony root, 100g of roasted Astragalus, 140g of stir-fried Atractylodes macrocephala, 100g of Ophiopogon japonicus, 200g of Fagopyrum truncatum, 100g of Morus alba, mix the medicinal materials, weigh the above medicinal materials according to the amount, add 20 times the weight of water, soak for 3 hours, heat to boiling, decoct twice, each time for 2 hours, combine the decoctions, filter, evaporate and concentrate, add 1.5 times the amount of ethanol after cooling, mix well, let stand overnight, take the supernatant, wash the precipitate with a small amount of 50% ethanol, combine the washing liquid and the filtrate, reduce the pressure to recover the ethanol, concentrate, cool and stand, filter, vacuum concentrate to a thick paste at low temperature, spray dry, pass through a 300-mesh sieve, add an appropriate amount of starch to prepare granules.

[0037] Example 3

[0038] Take 200g of raw Sanguisorba officinalis, 100g of red peony root, 200g of roasted Astragalus membranaceus, 100g of stir-fried Atractylodes macrocephala, 200g of Ophiopogon japonicus, 100g of Fagopyrum scabra, and 200g of Morus alba, mix the medicinal materials, weigh the above medicinal materials according to the amount, add 15 times the weight of water, soak for 3 hours, heat to boiling, decoct twice, each time for 2 hours, combine the decoctions, filter, evaporate and concentrate, and cool to obtain 2000 ml of decoction.

[0039] Example 4

[0040] Take 150g of raw Sanguisorba officinalis, 120g of red peony root, 150g of roasted Astragalus, 120g of stir-fried Atractylodes macrocephala, 150g of Ophiopogon japonicus, 150g of Fagopyrum tiliaceum, and 150g of Morus alba, mix the medicinal materials, weigh the above medicinal materials according to the amount, add 20 times the weight of water, soak for 3 hours, heat to boiling, decoct twice, each time for 2 hours, combine the decoctions, filter, evaporate and concentrate, add 1.5 times the amount of ethanol after cooling, mix well, let it stand overnight, take the supernatant, wash the precipitate with a small amount of 50% ethanol, combine the washing liquid and the filtrate, recover the ethanol under reduced pressure, concentrate, cool and stand, filter, vacuum concentrate to a thick paste at low temperature, spray dry, pass through a 300-mesh sieve, add an appropriate amount of dextrin and make tablets.

[0041] Example 5

[0042] Take 100g of raw Sanguisorba officinalis, 140g of red peony root, 100g of roasted Astragalus membranaceus, 140g of stir-fried Atractylodes macrocephala, 100g of Ophiopogon japonicus, 200g of Fagopyrum scabra, and 100g of Morus alba, mix the medicinal materials, weigh the above medicinal materials according to the amount, add 15 times the weight of water, soak for 3 hours, heat to boiling, decoct twice, each time for 2 hours, combine the decoctions, filter, evaporate and concentrate, and cool to obtain 2000 ml of decoction.

[0043] Example 6

[0044] Take 200g of raw Sanguisorba officinalis, 100g of red peony root, 200g of roasted Astragalus, 100g of stir-fried Atractylodes macrocephala, 200g of Ophiopogon japonicus, 100g of Fagopyrum truncatum, 200g of Morus alba, mix the medicinal materials, weigh the above medicinal materials according to the amount, add 20 times the weight of water, soak for 3 hours, heat to boiling, decoct twice, each time for 2 hours, combine the decoctions, filter, evaporate and concentrate, add 1.5 times the amount of ethanol after cooling, mix well, let stand overnight, take the supernatant, wash the precipitate with a small amount of 50% ethanol, combine the washing liquid and the filtrate, reduce the pressure to recover the ethanol, concentrate, cool and stand, filter, vacuum concentrate to a thick paste at low temperature, spray dry, pass through a 300-mesh sieve, add an appropriate amount of starch to prepare capsules.

[0045] Example 7: Clinical Experimental Results

[0046] 1 Research Methods

[0047] 1.1 Case source

[0048] This clinical study selected 108 patients with chest tumors who received radiotherapy in the Department of Oncology of Kunshan Hospital of Traditional Chinese Medicine and the Department of Radiotherapy of Zidong Branch of Jiangsu Provincial Hospital of Traditional Chinese Medicine from March 2022 to August 2023.

[0049] 2 Treatment options

[0050] 2.1 Control group plan

[0051] The specific radiotherapy plan for this study was formulated by the Department of Oncology of Kunshan Traditional Chinese Medicine Hospital and the Department of Radiotherapy of Jiangsu Provincial Traditional Chinese Medicine Hospital according to the patient's condition. The radiotherapy plan was 50-70Gy / 25-35 times, once a day, 5 times a week. Blood routine examinations were performed twice a week during radiotherapy. Patients with acute radiation pneumonia during radiotherapy in the control group were treated with glucocorticoids, and those with concurrent infection were treated with antibiotics and other symptomatic treatments. No Chinese medicine preparations were taken during radiotherapy.

[0052] 2.2 Treatment group regimen

[0053] Radiotherapy scheme: 50-70Gy / 25-35 times, 1 time / day, 5 times / week, the specific method is the same as the control group. At the same time, the cooling blood and dispersing blood stasis, invigorating qi and nourishing yin treatment method proposed based on the "blood stasis and heat" theory and the clinical experience of Professor Wu Mianhua is adopted, and the proposed invention is used for auxiliary radiotherapy. Take 15g of raw Sanguisorba officinalis, 12g of red peony root, 15g of roasted Astragalus, 12g of stir-fried Atractylodes macrocephala, 15g of Ophiopogon japonicus, 15g of golden buckwheat, and 15g of Morus alba, prepare according to the method of Example 1, take 2 times, one dose per day, 1 time in the morning and evening, the course of treatment is from 1 day before radiotherapy to one week after the end of radiotherapy, and add or subtract according to the symptoms on this basis.

[0054] 2.3 Statistical methods

[0055] The data were entered into a computer and processed using SPSS22.0 statistical software. The measurement data were expressed as χ±s, the t test was used for normal distribution, the rank sum test was used for non-normal distribution, the chi-square (χ2) test was used for count data, and the rank sum test was used for rank data. P < 0.05 was considered statistically significant.

[0056] 3 Results

[0057] 3.1 Patient general information

[0058] Comparison of each item before treatment: There were 54 patients in the control group, including 30 male patients and 24 female patients. The age of the patients in the treatment group was 65.57±12.71 years old; there were 18 patients diagnosed with esophageal cancer, 12 patients with lung cancer, 23 patients with breast cancer, and 1 patient with thymic tumor. There were 54 patients in the treatment group, including 30 male patients and 24 female patients; The age of the two groups was 68.39±12.06 years old, with 17 patients diagnosed with esophageal cancer, 12 with lung cancer, and 23 with breast cancer. The two groups of patients showed no significant difference in gender, age, and disease type by chi-square or t-test, with P values ​​> 0.05, and were comparable. See Table 1.

[0059] Table 1 General information of patients

[0060]

[0061]

[0062] 3.2 Occurrence of radiation pneumonitis

[0063] The patients in both the treatment group and the control group completed the scheduled radiotherapy dose. Among the 54 patients in the treatment group, 2 patients developed radiation pneumonitis symptoms of varying degrees during radiotherapy, with an incidence of 3.7%; among the 54 patients in the control group, 9 patients developed radiation pneumonitis symptoms of varying degrees during radiotherapy, with an incidence of 16.7%. Compared with the control group, the incidence of radiation pneumonitis in the treatment group was significantly reduced. The rank sum test between the two groups showed that Z = -2.237, P = 0.025 < 0.05, as shown in Table 2. Figure 1 .

[0064] Table 2 Occurrence of radiation pneumonitis

[0065]

[0066] 3.3 TCM clinical syndrome score

[0067] 3.3.1 Comparison of total scores of TCM clinical syndromes between the two groups before and after treatment

[0068] There was no significant difference in the total score of TCM clinical symptoms between the two groups of subjects before treatment by t test (P>0.05), and the data were comparable. The two groups of subjects were statistically analyzed before and after treatment, P<0.05, indicating that the total score of TCM clinical symptoms in the control group and the treatment group decreased before and after treatment. After treatment, the total score of TCM clinical symptoms in the two groups was 9.22±3.47 and 7.02±2.78, respectively. After t test, P<0.05 between the two groups, indicating that the treatment group was more significantly improved than the control group in the degree of improvement of the total score of TCM clinical symptoms. See Table 3.

[0069] Table 3 Comparison of total TCM symptom scores between the two groups at different time points ( point)

[0070]

[0071] 3.3.2 Comparison of the efficacy of TCM clinical syndrome scores between the two groups before and after treatment

[0072] There were 54 cases in the treatment group, 5 cases were clinically controlled, 9 cases were markedly effective, 17 cases were effective, 23 cases were ineffective, and the total effective rate was 57.40%. There were 54 cases in the control group, 22 cases were markedly effective, 13 cases were effective, 11 cases were ineffective, and the total effective rate was 79.90%. The improvement rate of TCM clinical syndrome scores in the two groups was tested by rank sum test, Z = -3.001, P = 0.003 < 0.05, and there was a statistically significant difference in the efficacy of TCM clinical syndrome scores between the treatment group and the control group. See Table 4, Figure 2 .

[0073] Table 4 TCM clinical syndrome score rating of efficacy after radiotherapy in the two groups (cases)

[0074]

[0075] 3.3.3 Comparison of KPS physical condition between the two groups after treatment

[0076] The KPS scores of the two groups of subjects before radiotherapy were compared by rank sum test, Z = -1.171, P = 0.241> 0.05, with no statistical difference and comparability. The KPS scores of the two groups after radiotherapy were statistically different, P = 0.041 < 0.05. In the control group, there was no statistical difference in the KPS scores before and after radiotherapy, 0.108> 0.05, while in the treatment group, there was a significant statistical difference in the KPS scores before and after radiotherapy, P = 0.013 < 0.05. See Table 5 for details.

[0077] Table 5 Comparison of KPS scores between the two groups before and after radiotherapy

[0078]

[0079] In the control group, 21 and 17 cases had improved and stable physical strength before and after radiotherapy, respectively, while in the treatment group, there were 28 and 16 cases. In the control group, there were 16 cases whose physical strength weakened after radiotherapy, while in the treatment group, there were 10 cases. The KPS scores of the two groups were tested by rank sum test, Z = -1.533, P = 0.125> 0.05, and there was no significant statistical difference in the KPS score efficacy between the treatment group and the control group. See Table 6, Figure 3 .

[0080] Table 6 KPS score efficacy rating table for the two groups

[0081]

[0082]

[0083] Example 8: Animal Experimental Results

[0084] 1. Materials

[0085] 1.1 Animals

[0086] SPF-grade C57BL / 6 male mice, weighing (20±2) g, were purchased from Jiangsu Jicui Yaokang Biotechnology Co., Ltd. and raised in the SPF animal room of the Experimental Animal Center of Nanjing University of Chinese Medicine. The weight and number of the mice were recorded before the experiment.

[0087] 1.2 Drug testing

[0088] Take 15g of raw Sanguisorba officinalis, 12g of red peony root, 15g of roasted Astragalus membranaceus, 12g of stir-fried Atractylodes macrocephala, 15g of Ophiopogon japonicus, 15g of Fagopyrum tiliaceum, and 15g of Morus alba. Add 10 times the amount of water to the weighed medicinal materials, soak them for 45min, then decoct them. Extract them twice for 2h and 1.5h respectively. Combine the medicinal solutions obtained from the two decoctions, concentrate them at constant temperature and low pressure to a crude drug mass concentration of 2.5g·mL-1, and store them in a -20℃ refrigerator for later use.

[0089] 2. Methods

[0090] 2.1 Grouped Dosing

[0091] The experimental animals were divided into 4 groups and randomly divided into blank control group (K), model group (M), high-dose Chinese medicine group (2.5g / mL) (ZG) and glycyrrhizic acid group (GA), 10 mice in each group. The K and M groups were given 0.9% sodium chloride solution by gavage, and the mice in each group were given the prepared drug solution by gavage at the standard of 0.2ml / d.

[0092] 2.2 Model preparation and sampling

[0093] After one week of adaptive feeding, C57BL / 6 mice were given a single whole-chest irradiation of 15Gy X-rays in all experimental groups except the blank control group. Before irradiation, the mice were placed in an induction box and inhaled with a 2% induction concentration of isoflurane solution. After the mice were anesthetized, they were fixed on a homemade wooden board in a supine position, with their limbs extended and their heads fixed, and a single whole-chest irradiation was given. After irradiation, mice in different groups were housed in separate cages, fed water and feed regularly, and the bedding was changed regularly. During the experiment, the weight changes of mice were monitored every 3-5 days, and the general state of the mice, such as hair, eating, and mental symptoms, were observed. Mice were killed 14 days after irradiation, blood was collected from the eyeballs, centrifuged at 3000r / min at 4℃, with a centrifugal radius of 8.37cm, and centrifuged for 10min. The supernatant was taken and frozen at -80℃ for later use. The whole lung was weighed, the lung coefficient was calculated, the left lung tissue was fixed with 4% paraformaldehyde solution for lung tissue pathology observation, and the right lung tissue was stored at -80℃ for subsequent molecular biology research.

[0094] 2.3 Statistical analysis

[0095] SPSS22.0 software was used for statistical analysis. The experimental results were expressed as x±s. One-way ANOVA was used for data comparison. The least significant difference (LSD) method was used for comparison between the two groups. P<0.05 indicated that the difference was statistically significant. GraphPad Prism 8 software was used for drawing.

[0096] 3 Results

[0097] 3.1 Effects on the body weight of RP mice

[0098] During the experiment, the mental state, diet, activity, hair gloss and hair loss of the mice in the control group were normal, and their weight showed a continuous growth trend. After irradiation, except for the control group, the mice in the simple irradiation group and the drug group were listless, their diet and activity decreased, and they liked to curl up together. The model group was the most obvious, and their weight decreased temporarily, and then slowly increased (see the results). Figure 4 ). 14 days after irradiation, the lung coefficient of the model group was significantly increased compared with the control group (P<0.05); compared with the M group, the lung coefficients of the mice in the ZG and GA groups were reduced, and the ZG group was significantly lower than the M group. (Results are shown in Figure 5 )

[0099] 3.2 Effects on HE in lung tissue of RP mice

[0100] HE staining microscopy revealed that the lung tissue and alveolar morphology of the mice in the control group were intact and clear, without inflammatory cell infiltration and bleeding. In the irradiated group, the alveolar wall was thickened, the inflammatory cell infiltration around the bronchi was obvious, the capillaries were extensively bleeding, and a large amount of cytoplasm was vacuolated. In the ZG group, no obvious abnormality was found in the alveolar structure under the microscope, but a small amount of inflammatory cell infiltration around the bronchi and a small amount of capillary bleeding were observed. The microscopic structure of the GA group was similar to that of the ZG group (see Figure 6 ). Thus, the present invention can significantly inhibit the development of lung inflammation in RP mice.

[0101] 3.3 Effects on alveolar inflammatory factors HMGB1, TNF-a, IL-1b, and IL-6 in RP mice

[0102] Compared with the control group, the inflammatory factors HMGB1, TNF-a, IL-1b, and IL-6 in the bronchoalveolar lavage fluid of the model group were significantly increased (P<0.001); compared with the model group, the inflammatory factors HMGB1, TNF-a, IL-1b, and IL-6 in the bronchoalveolar lavage fluid of the ZG and GA groups were significantly reduced (P<0.001). Therefore, the present invention can well intervene in the expression of inflammatory factors in the bronchoalveolar lavage fluid of mice. (Results are shown in Figure 7 )

[0103] 3.4 Inhibition of the expression of HMGB1, p-NF-kB, NF-kB, TLR4, and RAGE-related proteins in RP mice

[0104] Compared with the control group, the expression of HMGB1, p-NF-kB, NF-kB, TLR4, and RAGE proteins in the model group were significantly increased (P<0.001). Compared with the model group, the expression of HMGB1, p-NF-kB, NF-kB, TLR4, and RAGE proteins in the ZG group were significantly decreased (P<0.001), and the expression of p-NF-kB, NF-kB, and HMGB1 proteins in the GA group were significantly decreased (P<0.01, P<0.05). There was no significant difference in the expression of TLR4 protein in the GA group (the results are shown in Table 1). Figure 8 ). This suggests that the present invention may regulate the occurrence and development of radiation pneumonitis by down-regulating the expression of HMGB1, p-NF-kB, NF-kB, TLR4, and RAGE proteins in mouse lung tissue.

[0105] 4. Conclusion

[0106] The present invention can regulate the occurrence and development of radiation pneumonitis by inhibiting the expression of HMGB1 / NF-kB related pathway proteins and regulating the inflammatory response.

Claims

1. A Chinese medicine composition for preventing and treating radiation pneumonitis, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-20 parts of raw sanguisorba officinalis, 10-14 parts of red peony root, 10-20 parts of roasted astragalus, 10-14 parts of stir-fried atractylodes, 10-20 parts of ophiopogon, 10-20 parts of golden buckwheat and 10-20 parts of white mulberry bark.

2. The Chinese medicine composition for preventing and treating radiation pneumonitis according to claim 1, characterized in that: The drug is prepared from the following raw materials in parts by weight: 15 parts of raw sanguisorba officinalis, 12 parts of red peony root, 15 parts of roasted astragalus, 12 parts of stir-fried atractylodes, 15 parts of ophiopogon, 15 parts of golden buckwheat and 15 parts of white mulberry bark.

3. The Chinese medicine composition for preventing and treating radiation pneumonitis according to claim 1, characterized in that: The preparation method comprises the following steps: weighing the raw material medicine according to the dosage, adding 10-20 times the weight of water, soaking for 3 hours, heating to boiling, decocting twice, each time for 2-3 hours, combining the decoctions, filtering, evaporating and concentrating, cooling, adding 1.5 times the amount of ethanol, fully mixing, leaving overnight, taking the supernatant, washing the precipitate with a small amount of 50% ethanol, combining the washing liquid with the filtrate, recovering the ethanol under reduced pressure, concentrating, cooling and standing, filtering, vacuum low-temperature concentrating to a thick paste, spray drying, passing through a 300-mesh sieve, adding an appropriate amount of auxiliary materials and preparing the preparation.

4. The Chinese medicine composition for preventing and treating radiation pneumonitis according to claim 3, characterized in that: The dosage form of the preparation is granules, tablets, capsules, powders, pills or pastes.

5. The Chinese medicine composition for preventing and treating radiation pneumonitis according to claim 1, characterized in that: The preparation method comprises the following steps: weighing the raw material medicine according to the dosage, adding 10-20 times the weight of water, soaking for 3 hours, heating to boiling, decocting twice, each time for 2-3 hours, combining the decoctions, filtering, evaporating and concentrating, and cooling to obtain a decoction or oral liquid.

6. Use of the Chinese medicine composition for preventing and treating radiation pneumonia as claimed in claim 1 in the preparation of drugs for preventing and treating radiation pneumonia.

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