Traditional Chinese medicine pair for treating radiation enteropathy and application thereof

Abstract

The application discloses a traditional Chinese medicine pair for treating radiation enteropathy and application thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine pair comprises the following components in parts by weight: 2-20 parts of cortex fraxini and 2-20 parts of radix scrophulariae. The cortex fraxini has the effects of astringing and stopping dysentery, the radix scrophulariae has the effects of clearing heat and drying dampness, and the cortex fraxini and the radix scrophulariae have the effects of clearing heat and resolving toxins, invigorating the spleen and removing dampness, and astringing intestines and stopping dysentery, and have the effect of treating radiation enteropathy. The application solves the problem that effective drugs for treating radiation enteropathy are lacked in the prior art.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine preparation, in particular to a traditional Chinese medicine pair for treating radiation enteropathy and application thereof. BACKGROUND

[0002] Radiation enteropathy is intestinal injury caused by radiation. The disease often occurs in patients receiving radiotherapy, especially in patients with malignant tumors in the pelvic cavity, abdominal cavity and other parts. The main clinical manifestations are abdominal pain, diarrhea, hematochezia, mucous stool and tenesmus, which seriously affect the quality of life. At present, there is no effective treatment strategy for radiation enteropathy, therefore, there is an urgent need for a treatment drug for radiation enteropathy. SUMMARY

[0003] In order to solve the above technical problems, the purpose of the present application is to provide a traditional Chinese medicine pair for treating radiation enteropathy and application thereof, so as to solve the problem of lack of effective drugs for treating radiation enteropathy in the prior art.

[0004] The technical scheme for solving the above technical problems is as follows: a traditional Chinese medicine pair for treating radiation enteropathy is provided, which comprises the following components by weight: 2-20 parts of cortex fraxini and 2-20 parts of scrophulariaceae.

[0005] On the basis of the above technical scheme, the present application can also be improved as follows:

[0006] Further, the traditional Chinese medicine pair for treating radiation enteropathy comprises the following components by weight: 4-20 parts of cortex fraxini and 4-20 parts of scrophulariaceae.

[0007] Further, the traditional Chinese medicine pair for treating radiation enteropathy comprises the following components by weight: 10-15 parts of cortex fraxini and 10-15 parts of scrophulariaceae.

[0008] The present application also provides a preparation method of a traditional Chinese medicine pair extract for treating radiation enteropathy, which comprises the following steps in sequence:

[0009] (1) respectively cut the cortex fraxini and the scrophulariaceae according to claim 1 or 2, and soak them in water respectively;

[0010] (2) reflux extraction for 1-3 times respectively, and combine the extraction liquid;

[0011] (3) filter, concentrate and freeze-dry to obtain a freeze-dried powder, i.e. a traditional Chinese medicine pair extract for treating radiation enteropathy.

[0012] Further, in step (1), the ratio of material to liquid is 2-20g:80-800mL when soaking in water.

[0013] Further, in step (1), the soaking time in water is 25-35min.

[0014] Further, in step (2), the extraction is carried out at 100 DEG C under reflux for 1.5-2.5 h.

[0015] The beneficial effect of the above further technical solution is that the effective substances in the traditional Chinese medicinal materials are fully extracted.

[0016] The application further provides a traditional Chinese medicinal pair extract for treating radiation enteropathy prepared by the above method.

[0017] The application further provides application of the above traditional Chinese medicinal pair or traditional Chinese medicinal pair extract in preparation of a medicament for treating radiation enteropathy.

[0018] Further, the radiation enteropathy includes acute radiation enteropathy, chronic radiation enteropathy and ulcerative colitis.

[0019] The application further provides a medicament for treating radiation enteropathy, which comprises the above traditional Chinese medicinal pair or traditional Chinese medicinal pair extract.

[0020] Further, the dosage form of the medicament is an oral preparation or an enema preparation permitted in pharmacy.

[0021] The application has the following beneficial effects:

[0022] 1. The application provides a traditional Chinese medicinal pair and extract for treating radiation enteropathy under the guidance of modern pharmacology according to the main pathogenesis and clinical symptoms of radiation enteropathy, i.e. fire toxin accumulation and spleen deficiency and dampness stagnation. Cortex fraxini can astringe and stop diarrhea, and radix scrophulariae can clear heat and dry dampness. Cortex fraxini and radix scrophulariae can play the functions of clearing heat and resolving toxins, invigorating the spleen and eliminating dampness, and astringing the intestines and stopping diarrhea, and have a significant effect on treating radiation enteropathy.

[0023] 2. The Cortex fraxini-radix scrophulariae pair can be used for improving the shedding of intestinal villi, reducing intestinal oxidative stress and inflammatory infiltration, and maintaining the intestinal barrier function. The Cortex fraxini-radix scrophulariae pair can also promote the proliferation of intestinal cells after irradiation, and reduce the apoptosis of intestinal cells after irradiation.

[0024] 3. The Cortex fraxini-radix scrophulariae extract can significantly reduce the symptoms of radiation enteropathy, reduce intestinal damage, reduce the expression of inflammatory factors and cell apoptosis after continuous oral administration for 7 days. The Cortex fraxini-radix scrophulariae pair has a significant treatment advantage in treating radiation enteropathy. DETAILED DESCRIPTION

[0025] The principles and characteristics of the application are described below, and the examples are only used to explain the application and not to limit the scope of the application. If the specific conditions are not specified in the examples, the conventional conditions or the conditions recommended by the manufacturer are used. If the reagents or instruments are not specified by the manufacturer, they are conventional products that can be purchased on the market.

[0026] Example 1:

[0027] A traditional Chinese medicine pair for treating radiation enteropathy comprises the following components in parts by weight: 12 parts of cortex fraxini and 12 parts of radix scrophulariae.

[0028] A traditional Chinese medicine pair extract for treating radiation enteropathy is prepared by the following steps in sequence:

[0029] The dried cortex fraxini and radix scrophulariae are respectively cut into pieces, and are respectively put into 3L round-bottom flasks, and are respectively soaked in 960ml of water for 30 minutes.

[0030] The two kinds of medicine are respectively refluxed for 2 hours under the condition of 100℃ in a heat-collecting constant-temperature heating magnetic stirrer, and the extraction liquid is combined, filtered, and rotary evaporated to obtain a concentrated liquid, which is freeze-dried to obtain the traditional Chinese medicine pair extract for treating radiation enteropathy (the extraction rate of crude drug is 15-30%).

[0031] A medicine for treating radiation enteropathy comprises the traditional Chinese medicine pair for treating radiation enteropathy or the traditional Chinese medicine pair extract for treating radiation enteropathy.

[0032] Example 2:

[0033] A traditional Chinese medicine pair for treating radiation enteropathy comprises the following components in parts by weight: 4 parts of cortex fraxini and 20 parts of radix scrophulariae.

[0034] A traditional Chinese medicine pair extract for treating radiation enteropathy is prepared by the following steps in sequence:

[0035] The dried cortex fraxini and radix scrophulariae are respectively cut into pieces, and are respectively put into 3L round-bottom flasks, and are respectively soaked in 960ml of water for 25 minutes.

[0036] The two kinds of medicine are respectively refluxed for 1.5 hours under the condition of 100℃ in a heat-collecting constant-temperature heating magnetic stirrer, and the extraction liquid is combined, filtered, and rotary evaporated to obtain a concentrated liquid, which is freeze-dried to obtain the traditional Chinese medicine pair extract for treating radiation enteropathy (the extraction rate of crude drug is 15-30%).

[0037] A medicine for treating radiation enteropathy comprises the traditional Chinese medicine pair for treating radiation enteropathy or the traditional Chinese medicine pair extract for treating radiation enteropathy.

[0038] Example 3:

[0039] A traditional Chinese medicine pair for treating radiation enteropathy comprises the following components in parts by weight: 20 parts of cortex fraxini and 4 parts of radix scrophulariae.

[0040] A traditional Chinese medicine pair extract for treating radiation enteropathy is prepared by the following steps in sequence:

[0041] The dried cortex fraxini and radix scrophulariae were respectively cut into pieces, and were respectively put into 3L round bottom flask, and were respectively soaked in 960ml water for 35min, and were respectively extracted by refluxing in heat collecting constant temperature heating magnetic stirrer at 100℃ for 2.5h, and the extraction liquid was obtained by combining, filtering and rotary evaporation, and was freeze-dried to obtain the traditional Chinese medicine pair extract for treating radiation enteropathy (the extraction rate of crude drug was 15-30%).

[0042] A medicine for treating radiation enteropathy, comprising the traditional Chinese medicine pair for treating radiation enteropathy or the traditional Chinese medicine pair extract for treating radiation enteropathy.

[0043] Comparative example 1:

[0044] A traditional Chinese medicine for treating radiation enteropathy, comprising the following components by weight: cortex fraxini 12g.

[0045] A traditional Chinese medicine extract for treating radiation enteropathy, comprising the following steps in sequence: same as example 1.

[0046] A medicine for treating radiation enteropathy, comprising the traditional Chinese medicine for treating radiation enteropathy or the traditional Chinese medicine extract for treating radiation enteropathy.

[0047] Comparative example 2:

[0048] A traditional Chinese medicine for treating radiation enteropathy, comprising the following components by weight: radix scrophulariae 12g.

[0049] A traditional Chinese medicine extract for treating radiation enteropathy, comprising the following steps in sequence: same as example 1.

[0050] A medicine for treating radiation enteropathy, comprising the traditional Chinese medicine for treating radiation enteropathy or the traditional Chinese medicine extract for treating radiation enteropathy.

[0051] Test example

[0052] I. Evaluation of intestinal pathological injury

[0053] The extracts obtained from example 1 and comparative examples 1-2 were used for intestinal pathological injury evaluation experiment by gavage. The implementation method was as follows: the mice were divided into normal group, model group, cortex fraxini group 2.8g / kg, radix scrophulariae group 2.8g / kg and cortex fraxini-radix scrophulariae group 2.8g / kg. After X-ray irradiation, the mice were continuously gavaged for 7 days, and the body weight was measured every day; on the 8th day, the intestinal tissue of the mice was taken, and the H&E results were obtained, as shown in table 1.

[0054] Table 1: Traditional Chinese medicine and drug pair reduce intestinal pathological injury of RII mice

[0055]

[0056] The experimental results: from Table 1, the H&E results of the intestinal tissue of the mice showed that the intestinal villi and intestinal crypt structure of the normal group of mice was complete, without villi rupture, inflammatory cell infiltration phenomenon; after irradiation, the intestinal structure of the mice was damaged, inflammatory cell infiltration, intestinal villi rupture, intestinal crypt swelling, crypt number reduction, Chiu's score increased; after drug treatment, it can reduce the pathological injury of intestinal tissue of radiation damage model mice, among which the effect of Cortex Catalpa-Cortex Scophulariae group is better than that of each single drug group.

[0057] II. Evaluation of intestinal pathological injury

[0058] The extract prepared in Example 1 was administered by gavage to perform the intestinal pathological injury evaluation experiment. The implementation method is: the mice are divided into normal group, model group, Cortex Catalpa-Cortex Scophulariae low (0.7 g / kg), medium (1.4 g / kg), high dose (2.8 g / kg) group. After X-ray irradiation, the mice were continuously gavaged for 7 days, and the body weight was measured every day; on the 8th day, the H&E results of the intestinal tissue of the mice were taken, as shown in Table 2.

[0059] Table 2: Chinese medicine drug pair reduces the pathological injury of intestinal tissue of RII mice

[0060]

[0061]

[0062] ## P<0.01 compared with the Control group; ** P<0.01 compared with the RII group

[0063] The experimental results: after irradiation, the body weight of the model group of mice decreased significantly; the low, medium and high doses of Cortex Catalpa-Cortex Scophulariae can inhibit the decrease of the body weight of the mice, indicating that Cortex Catalpa-Cortex Scophulariae can inhibit the weight loss of the mice after irradiation.

[0064] From Table 2, the H&E results of the intestinal tissue of the mice showed that the intestinal villi and intestinal crypt structure of the normal group of mice was complete, without villi rupture, inflammatory cell infiltration phenomenon; after irradiation, the intestinal structure of the mice was damaged, inflammatory cell infiltration, intestinal villi rupture, intestinal crypt swelling, crypt number reduction, Chiu's score increased; after drug treatment, it can reduce the rupture of villi and swelling of crypt. It is proved that Cortex Catalpa-Cortex Scophulariae can reduce the pathological injury of intestinal tissue of radiation damage model mice.

[0065] III. Detection of MDA and SOD content in intestinal tissue

[0066] On the basis of the above, the intestinal tissue of the mice in each group was taken, and the levels of total superoxide dismutase (SOD, Nanjing Jiancheng Biological Engineering Research Co., Ltd.) and malondialdehyde (MDA, Nanjing Jiancheng Biological Engineering Research Co., Ltd.) were detected according to the kit operation instruction, and the results are shown in Table 3.

[0067] Table 3 Antioxidant capacity of RII mice intestinal tissue enhanced by Chinese medicine pair

[0068]

[0069] ## P<0.01 compared with the Control group; ** P<0.01 compared with the RII group

[0070] As shown in Table 3, radiation can cause a large number of active oxygen in the intestinal tract, and significantly reduce the antioxidant capacity of the intestinal tissue. Compared with the normal group, 10Gy irradiation can significantly reduce the antioxidant capacity of the mice, and the administration of the cortex fraxini-baical skullcap can improve the antioxidant enzyme activity and improve the antioxidant capacity, indicating that the cortex fraxini-baical skullcap of the application can improve the antioxidant capacity of the intestinal tract of the mice with radiation enteropathy.

[0071] Four, inflammation factor detection

[0072] On the basis of the above one, the intestinal tissue of the mice in each group was taken, and the levels of inflammatory factors (IL-6, IL-10, IL-1β, TNF-α) were detected according to the operation instruction of the ELISA kit, and the results are shown in Table 4.

[0073] Table 4 Inflammatory factor levels of RII mice intestinal tissue reduced by Chinese medicine pair

[0074]

[0075] ## P<0.01 compared with the Control group; ** P<0.01 compared with the RII group; * P<0.05 compared with the RII group

[0076] As shown in Table 4, after irradiation, the intestinal inflammation of the mice is an important pathological process. Compared with the normal group, radiation can significantly increase the pro-inflammatory factors TNF-α, IL-1β and IL-6, and decrease the anti-inflammatory factor IL-10, and the administration can reduce the expression of the pro-inflammatory factors and increase the expression of the anti-inflammatory factors, indicating that the cortex fraxini-baical skullcap of the application can reduce the inflammatory factor levels of the intestinal tract of the mice with radiation enteropathy.

[0077] Five, detection of intestinal proliferation of mice

[0078] On the basis of the above one, the intestinal tissue of the mice in each group was fixed, embedded and sectioned, and Ki67 fluorescence staining was performed to detect the intestinal proliferation of the mice. Ki67 is a cell proliferation marker, and the results are shown in Table 5.

[0079] Table 5 Cell proliferation in RII mice intestinal tissue promoted by Chinese medicine pair

[0080]

[0081] From table 5, it can be seen that, compared with the normal group, the number of Ki67 positive cells in the intestinal tract of the radiation model group mice is significantly reduced, indicating that radiation significantly inhibits cell proliferation; and the number of Ki67 positive cells in the three dose groups of the invention is increased, indicating that the invention can promote the proliferation of intestinal tissue cells of mice after radiation.

[0082] Six, detection of intestinal tract fine apoptosis

[0083] On the basis of the above, the intestinal tissue of the mice in each group was fixed, embedded and sectioned, and the TUNEL kit was used to detect the fine apoptosis of the intestinal tract of the mice, and X-ray can cause apoptosis of cells in the intestinal tissue, and the results are shown in table 6.

[0084] Table 6 Inhibition of cell apoptosis in intestinal tissue of RII mice by traditional Chinese medicine pair

[0085]

[0086] ## P<0.01 compared with the Control group; ** P<0.01 compared with the RII group;

[0087] From table 6, it can be seen that, compared with the normal group, the apoptosis of the intestinal tract of the mice after radiation is significantly increased, and the administration of the invention can dose-dependently inhibit the X-ray-induced apoptosis of the intestinal tract of the mice, indicating that the invention can inhibit the apoptosis of the intestinal tissue cells of the radiation-induced intestinal injury mice.

[0088] In summary, the traditional Chinese medicine pair "cortex fraxini-bark of scapharina" of the invention is used in combination, and is prepared into an oral preparation or an oral drug for clinical use, which can play a role in treating radiation enteropathy.

[0089] The above only describes the preferred embodiments of the invention, and is not intended to limit the invention, and any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the invention shall be included in the protection scope of the invention.

Claims

1. A traditional Chinese medicine pair for treating radiation enteropathy, characterized in that, The Chinese medicine pair for treating radiation enteropathy is prepared from the following components in parts by weight: cortex fraxini 2-20 parts and scutellariae 2-20 parts.

2. The traditional Chinese medicine pair for treating radiation enteropathy according to claim 1, characterized in that, The Chinese medicine pair for treating radiation enteropathy is prepared from the following components in parts by weight: cortex fraxini 10-15 parts and scutellariae 10-15 parts.

3. A method for preparing a traditional Chinese medicine pair extract for treating radiation enteropathy, characterized in that, The method comprises the following steps in sequence: (1) separately cutting cortex fraxini and scutellariae as claimed in claim 1 or 2, and separately soaking in water; (2) separately refluxing and extracting 1-3 times, and combining the extract; (3) filtering, concentrating and freeze-drying to obtain a freeze-dried powder, i.e. the Chinese medicine pair extract for treating radiation enteropathy.

4. The preparation method of the traditional Chinese medicine pair extract for treating radiation enteropathy according to claim 3, characterized in that, In step (1), the ratio of the material to water in the soaking is 2-20 g: 80-800 mL.

5. The preparation method of the traditional Chinese medicine pair extract for treating radiation enteropathy according to claim 3, characterized in that, In step (2), the refluxing and extracting is performed at 100 ℃ for 1.5-2.5 h.

6. The Chinese medicine pair extract for treating radiation enteropathy prepared by the method as claimed in any one of claims 3-5.

7. Use of the Chinese medicine pair for treating radiation enteropathy as claimed in claim 1 or the Chinese medicine pair extract for treating radiation enteropathy as claimed in claim 6 in the preparation of a medicament for treating radiation enteropathy.

8. Use according to claim 7, characterized in that, Radiation enteropathy includes acute radiation enteropathy and chronic radiation enteropathy.

9. A medicament for treating radiation enteropathy, characterized by, The Chinese medicine pair for treating radiation enteropathy as claimed in claim 1 or the Chinese medicine pair extract for treating radiation enteropathy as claimed in claim 6.

10. The medicament for treating radiation enteropathy according to claim 9, characterized in that, The dosage form of the medicament is an orally administrable preparation or an enema preparation permitted in pharmacy.

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