Composition for protecting gastrointestinal mucosa after chemotherapy as well as preparation method and application of composition

Abstract

The invention provides a composition for gastrointestinal mucosa protection after chemotherapy and a preparation method and application thereof, and belongs to the technical field of medicine preparation. The composition comprises a traditional Chinese medicine component, phosphatidylcholine and soybean oligosaccharide, the traditional Chinese medicine components comprise a cordyceps militaris extract, loropetalum chinense and Chinese yam. The composition can effectively protect gastric mucosa and repair gastrointestinal mucosa injury, and especially has a good repair effect on gastrointestinal mucosa injury caused by chemotherapy.

Description

Technical Field

[0001] This invention provides a composition for gastrointestinal mucosal protection after chemotherapy, its preparation method, and its application, belonging to the field of pharmaceutical preparation technology. Background Technology

[0002] Chemotherapy aims to kill cancer cells using chemotherapeutic drugs. Because these drugs are cytotoxic, they can cause side effects, the most common being digestive system reactions such as nausea and vomiting. Antiemetics are commonly used to treat these side effects, but this treatment itself can also cause adverse reactions such as abdominal pain, constipation, and diarrhea.

[0003] Chinese patent CN101708201B discloses a drug for treating gastric ulcers, with Loropetalum chinense extract as the sole active ingredient. The Loropetalum chinense extract is obtained by the following method: fresh Loropetalum chinense material is crushed, and a combined bacterial enzymatic hydrolysis method is used to obtain a Loropetalum chinense bio-cell wall-breaking product. Dynamic temperature immersion extraction is employed at 85℃ for 120 minutes, with a pH of 6.5±0.2; the temperature immersion extraction time is 16 hours to obtain an extract. First, chlorophyll and other fat-soluble impurities are removed using an alcohol extraction and water precipitation method, and then water-soluble impurities such as sugars are removed using a water extraction and alcohol precipitation method to obtain a crude extract, with a weight of 5.5-6% of the raw material weight. The bacterial strain used for the combined bacterial enzymatic hydrolysis is a Dutch strain of Bacillus subtilis.

[0004] The *Zhejiang Journal of Traditional Chinese Medicine* published a study in its April 2015 issue (Volume 50, Issue 4) entitled "Screening Study of Active Parts of Loropetalum chinense Flower in the Treatment of Experimental Gastric Ulcers." The study used cold water immersion restraint to induce experimental gastric ulcers in mice and pyloric ligation to induce them in rats, observing the effects of different extracts from Loropetalum chinense flower on the treatment of experimental gastric ulcers. The results showed that all extracts from Loropetalum chinense flower had a certain inhibitory effect on experimental gastric ulcers in mice and rats, with the n-butanol extract showing a particularly significant effect.

[0005] However, using only Loropetalum chinense has limited protective effects on the gastric mucosa and its effectiveness in relieving chemotherapy-induced vomiting. Summary of the Invention

[0006] This invention provides a composition for protecting the gastrointestinal mucosa after chemotherapy, its preparation method, and its application. The composition can effectively protect the gastric mucosa and repair gastrointestinal mucosal damage, especially for gastrointestinal mucosal damage caused by chemotherapy.

[0007] Terminology Explanation: Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0008] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0009] Definitions of standard chemical terms can be found in the references “Technical Specifications for Inspection and Evaluation of Health Foods”, 2003, and “Chinese Pharmacopoeia”, 2020.

[0010] Unless otherwise specified, conventional methods within the scope of the art, such as HPLC, weighing determination, etc., shall be used.

[0011] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0012] The term "white-flowered Loropetalum" used in this article refers to: Latin name: Loropetalum chinense (R. Br.)Oliv. is a plant belonging to the Hamamelidaceae family and the Loropetalum genus. Its flowers, stems, leaves, and branches can all be used medicinally. In this embodiment of the invention, the entire Loropetalum chinense plant is used.

[0013] In a first aspect, the present invention provides: a composition for gastrointestinal mucosal protection after chemotherapy, comprising: traditional Chinese medicine components, phosphatidylcholine and soybean oligosaccharides; wherein the traditional Chinese medicine components are Cordyceps militaris extract, Loropetalum chinense and Dioscorea opposita.

[0014] Furthermore, the mass ratio of the Cordyceps militaris extract, Loropetalum chinense and Dioscorea opposita is (37-60):(200-400):(5-42).

[0015] Preferably, the mass ratio of the Cordyceps militaris extract, Loropetalum chinense, and Dioscorea opposita is 40:200:5, 60:400:20, 50:300:15, 37:200:41.5, 42:250:22, 50:300:15.6, or any combination thereof.

[0016] Furthermore, the mass ratio of phosphatidylcholine to soybean oligosaccharides is (25-60):(15-60).

[0017] Preferably, the mass ratio of phosphatidylcholine to soybean oligosaccharides is within the range of 60:40, 30:20, 40:30, 28:57.3, 38:28, 39:18, or any combination thereof.

[0018] Further, the composition comprises, by weight, 240-500 parts of traditional Chinese medicine components, 25-60 parts of phosphatidylcholine and 15-60 parts of soybean oligosaccharides.

[0019] Secondly, the present invention provides a method for preparing a composition for gastrointestinal mucosal protection after chemotherapy, comprising the following steps: (1) Cordyceps militaris was extracted and dried to obtain Cordyceps militaris extract; Loropetalum chinense was pulverized and Dioscorea opposita was cooked and then pulverized to obtain Loropetalum chinense powder and cooked Dioscorea opposita powder. (2) The Cordyceps militaris extract and phosphatidylcholine were stirred at a constant temperature and sieved to obtain mixture A; (3) Mix the white-flowered Loropetalum powder and cooked yam powder evenly, then add soybean oligosaccharide and continue to mix evenly. Sieve to obtain mixture B; (4) Mix mixture A and mixture B evenly to obtain the final product.

[0020] Further, the extraction in step (1) is water extraction or alcohol extraction.

[0021] Preferably, the extraction is performed by reflux with water for 3 hours.

[0022] Furthermore, the crushed Loropetalum chinense described in step (1) also includes sieving through a 100-200 mesh sieve.

[0023] Furthermore, the particle size of the yam after cooking and crushing in step (1) is 50-200μm.

[0024] Furthermore, the constant temperature in step (2) is 30-40℃.

[0025] Furthermore, the sieving in step (2) is 100-200 mesh.

[0026] Thirdly, the present invention provides a health food product comprising the above-described composition.

[0027] Fourthly, the present invention provides a pharmaceutical product comprising the above-described composition.

[0028] Furthermore, the drug also includes excipients.

[0029] Preferably, the excipients include at least one of the following: diluent, thickener, lubricant, disintegrant, and stabilizer.

[0030] Furthermore, the dosage forms of the medicine include: tablets, injections, capsules, granules, suppositories, pills, ointments, creams, inhaled preparations, sprays, aerosols, gels, powders, syrups, liniments, ointments, films, tinctures, patches, plasters, oral solutions, oral suspensions, oral emulsions, and mixtures.

[0031] Fifthly, the present invention provides the use of the above composition in the preparation of health food for the auxiliary protection of gastrointestinal mucosal injury.

[0032] In a sixth aspect, the present invention provides the use of the above composition in the preparation of a medicament for treating gastrointestinal mucosal diseases.

[0033] Furthermore, the gastrointestinal mucosal disease is at least one of the following: gastrointestinal mucosal damage caused by chemotherapy, gastrointestinal mucosal damage after radiotherapy, drug-induced gastrointestinal mucosal damage, combined gastrointestinal mucosal damage caused by combined radiotherapy and chemotherapy, gastrointestinal mucosal damage related to adjuvant drugs such as targeted drugs in tumor treatment, chemotherapy-related gastrointestinal mucosal inflammation and ulcers, mucosal damage caused by radiation enteritis / gastritis, and gastrointestinal mucosal lesions caused by nonsteroidal anti-inflammatory drugs and antibiotics.

[0034] Beneficial effects: The composition of the present invention, with specific amounts of Loropetalum chinense, Cordyceps militaris and Dioscorea opposita, exerts a synergistic effect, and with specific amounts of phosphatidylcholine and soybean oligosaccharides, significantly reduces the ulcer area and ulcer volume in rats, reaching a level lower than that of the positive control group. At the same time, it can significantly reduce the number of vomitings in rats caused by cisplatin. Detailed Implementation

[0035] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0036] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0037] I. Examples and Comparative Examples The materials of the compositions for gastrointestinal mucosal protection after chemotherapy in the embodiments and comparative examples of the present invention are shown in Tables 1 and 2.

[0038] Table 1 (Unit: parts by weight)

[0039] Table 2 (Unit: parts by weight)

[0040] Note: * indicates that Cordyceps militaris extract has been replaced with an equal amount of Ophiopogon japonicus extract.

[0041] II. Preparation method of composition for adjunctive protection against gastrointestinal mucosal injury Preparation methods of Examples 1-6, Comparative Examples 5, and Comparative Example 7: (1) Cordyceps militaris was extracted by reflux with water for 3 hours, the filtrate was concentrated and freeze-dried to obtain Cordyceps militaris extract; Loropetalum chinense was dried and pulverized and passed through a 100-mesh sieve; Dioscorea opposita was cooked, dried and pulverized (particle size 100μm) to obtain Loropetalum chinense powder and cooked Dioscorea opposita powder. (2) The Cordyceps militaris extract and phosphatidylcholine were stirred at a constant temperature (35±0.5℃) and a speed of 200r / min for 30 minutes, and then passed through a 100-mesh sieve to obtain mixture A; (3) Mix the white-flowered Loropetalum powder and cooked yam powder at 20 r / min for 10 minutes, then add soybean oligosaccharide and continue mixing at 20 r / min for 5 minutes. Sieve through a 100-mesh sieve to obtain mixture B; (4) Mix mixture A and mixture B at 25 r / min for 30 minutes to obtain the final product.

[0042] Preparation method of Comparative Example 1: (1) Dry the white-flowered Loropetalum and then pulverize it, passing it through a 100-mesh sieve; cook the yam, dry it, and then pulverize it (particle size 100μm) to obtain white-flowered Loropetalum powder and cooked yam powder; (2) Phosphatidylcholine was kept at a constant temperature (35±0.5℃) and stirred at a speed of 200r / min for 30 minutes, and then passed through a 100-mesh sieve to obtain phosphatidylcholine A; (3) Mix the white-flowered Loropetalum powder and cooked yam powder at 20 r / min for 10 minutes, then add soybean oligosaccharide and continue mixing at 20 r / min for 5 minutes. Sieve through a 100-mesh sieve to obtain mixture B; (4) Mix phosphatidylcholine A and mixture B at 25 r / min for 30 minutes to obtain the final product.

[0043] Preparation method of Comparative Example 2: (1) Cordyceps militaris was extracted by reflux with water for 3 hours, filtered, concentrated and freeze-dried to obtain Cordyceps militaris extract; (2) The Cordyceps militaris extract and phosphatidylcholine were stirred at a constant temperature (35±0.5℃) and a speed of 200r / min for 30 minutes, and then passed through a 100-mesh sieve to obtain mixture A; (3) Stir the soybean oligosaccharide at 20 r / min for 35 minutes, and then pass it through a 100-mesh sieve to obtain soybean oligosaccharide B; (4) Mix mixture A and soybean oligosaccharide B at 25 r / min for 30 minutes to obtain the final product.

[0044] Preparation method of Comparative Example 3: (1) Dry the white-flowered Loropetalum chinense and then crush it into powder, passing it through a 100-mesh sieve; (2) Stir phosphatidylcholine at a constant temperature (35±0.5℃) and a speed of 200r / min for 30 minutes, then pass it through a 100-mesh sieve to obtain phosphatidylcholine A; (3) Stir the white flower loropetalum powder at 20 r / min for 10 minutes, then add soybean oligosaccharide and continue mixing at 20 r / min for 5 minutes. Sieve through a 100-mesh sieve to obtain mixture B; (4) Mix phosphatidylcholine A and mixture B at 25 r / min for 30 minutes to obtain the final product.

[0045] Preparation method of Comparative Example 4: (1) Extract Cordyceps militaris by reflux for 3 hours, filter, concentrate and freeze dry the filtrate to obtain Cordyceps militaris extract; cook and dry yam and then pulverize (particle size 100μm) to obtain cooked yam powder. (2) The Cordyceps militaris extract and phosphatidylcholine were stirred at a constant temperature (35±0.5℃) and a speed of 200r / min for 30 minutes, and then passed through a 100-mesh sieve to obtain mixture A; (3) Stir the cooked yam powder at 20 r / min for 10 minutes, then add soybean oligosaccharides and continue mixing at 20 r / min for 5 minutes. Sieve through a 100-mesh sieve to obtain mixture B; (4) Mix mixture A and mixture B at 25 r / min for 30 minutes to obtain the final product.

[0046] Preparation method of Comparative Example 6: (1) Ophiopogon japonicus was extracted by reflux with water for 3 hours, the filtrate was concentrated and freeze-dried to obtain Ophiopogon japonicus extract; Loropetalum chinense was dried and pulverized and passed through a 100-mesh sieve; Dioscorea opposita was cooked, dried and pulverized (particle size 100μm) to obtain Loropetalum chinense powder and cooked Dioscorea opposita powder. (2) Ophiopogon japonicus extract and phosphatidylcholine were stirred at a constant temperature (35±0.5℃) and a speed of 200r / min for 30 minutes, and then passed through a 100-mesh sieve to obtain mixture A; (3) Mix the white-flowered Loropetalum powder and cooked yam powder at 20 r / min for 10 minutes, then add soybean oligosaccharide and continue mixing at 20 r / min for 5 minutes. Sieve through a 100-mesh sieve to obtain mixture B; (4) Mix mixture A and mixture B at 25 r / min for 30 minutes to obtain the final product.

[0047] III. Experiments on gastric ulcers induced by glacial acetic acid in rats 1. Main instruments and equipment An animal electronic balance with a graduation value (d) of 0.1g, a stereo microscope (with a micrometer), a magnifying glass, vernier calipers, a 100m mortar, 50ml and 500ml beakers, a 5mm inner diameter and 10mm long stainless steel tube (Oxford cup), anesthesia jars, 50μL microsyringes, 1mL and 10mL disposable syringes, a rat dissection board, sutures, hemostatic forceps, medical scissors and forceps, etc.

[0048] 2. Chemical reagents (1) Formaldehyde, on the day of rat dissection, was diluted with distilled water to a concentration of 1w% in 400ml and 5w% in 600ml.

[0049] (2) Glacial acetic acid: 10 mg was taken from the rat on the day of surgery, without dilution.

[0050] (3) Sodium pentobarbital, prepared at a concentration of 2wt% in 40ml. Or ether, undiluted, add an appropriate amount to the anesthesia jar before use.

[0051] 3. Experimental Methods (1) After fasting for 24 hours, rats were anesthetized by intraperitoneal administration of 2w% sodium pentobarbital at 45 mg / kg.

[0052] (2) The rats were fixed on a dissecting board. Under aseptic conditions in a clean bench, the upper abdominal wall was cut open 20-25 mm, surrounding tissues were separated, and the stomach was exposed to a clear location. A dry cotton ball was used to dry the surface fluid of the gastric serosa. A stainless steel tube (Oxford cup) with an inner diameter of 5 mm and a length of 10 mm was placed vertically on the serosa of the stomach body. 0.2 ml of glacial acetic acid was added into the lumen, and the time was immediately started. After 1.5 minutes, the glacial acetic acid was removed with a cotton swab, the stainless steel tube (Oxford cup) was removed, and the surface glacial acetic acid was further dried with a sterile cotton ball. The surgical incision was then sutured. The rats were allowed to eat normally after surgery.

[0053] (3) On day 2 after surgery, rats were randomly divided into a model control group, a test substance group and a positive drug group. Each group was given the test substance by ig for 14 days (the model control group was given the solvent).

[0054] (4) After the rats were given the test substance for the last time, they were fasted but allowed to drink water. During the 24-hour fasting period, the rats were placed in stainless steel wire cages to prevent them from accidentally ingesting feces, hair and bedding, and to keep the rats' stomachs empty.

[0055] (5) The rat was euthanized by dislocation of the cervical vertebrae, fixed on a dissecting board, the abdominal cavity was opened, the adhesions around the stomach and duodenum were dissected, and the cardia was ligated with hemostatic forceps and sutures. Then, a No. 6 needle was inserted into the stomach through the duodenum and pylorus. The pylorus was ligated with hemostatic forceps and sutures. 8 mL of 1% formaldehyde solution was drawn up with a 10 mL syringe and injected into the stomach. The needle was removed, and the complete stomach body filled with 1% formaldehyde solution was cut off and soaked in 5% formaldehyde solution for 20 min.

[0056] (6) Cut open the stomach wall along the greater curvature of the stomach, rinse the stomach contents with tap water, cut off a piece of stomach body tissue larger than the ulcer surface, lay the stomach body flat with the ulcer surface facing up, measure the length and width of the ulcer with a stereomicroscope or vernier calipers, and calculate the ulcer area.

[0057] (7) Use filter paper strips to absorb the moisture in the ulcer, and use a micro-syringe to slowly inject blue ink into the ulcer until it is level with the ulcer perimeter. Record the amount of blue ink injected as the ulcer volume.

[0058] Note: ig refers to administration by gavage.

[0059] 4. Experimental Grouping (1) Experimental animals: SPF male rats, weighing 200-250g, 8 rats per group.

[0060] (2) Grouping: model control group, test substance group and positive drug group. Among them, the test substance is the composition prepared by Examples 1-3 and Comparative Examples 1-7, and the positive drug is Sanjiuweitai granules.

[0061] Example 3 was divided into high, medium and low dose groups, with dosages of 0.5 g / kg (low dose group), 1 g / kg (medium dose group) and 1.5 g / kg (high dose group), respectively.

[0062] The dosage for Examples 1-2 and Comparative Examples 1-7 was 0.5 g / kg.

[0063] The dosage of Sanjiu Weitai granules is 0.5g / kg.

[0064] The solvent was water for injection, and the gavage volume was 2 mL / 100g body weight.

[0065] 5. Experimental Results The ulcer area and ulcer volume obtained from the experiment are shown in Table 3.

[0066] Table 3

[0067] Note: Different subscripts (lowercase English letters) in the same column of data a-d indicate significant differences (P<0.05).

[0068] The Chinese medicine components in Comparative Example 1 consisted only of Loropetalum chinense and Dioscorea opposita; those in Comparative Example 2 consisted only of Cordyceps militaris; those in Comparative Example 3 consisted only of Loropetalum chinense; and those in Comparative Example 4 consisted only of Cordyceps militaris and Dioscorea opposita. Although the ulcer area and ulcer volume of the rats in these examples were improved, they could not reach the level of the positive control group and showed significant differences from the positive control group.

[0069] Although Comparative Example 5 contained Loropetalum chinense, Cordyceps militaris, and Dioscorea opposita, the change in their dosage relationship led to some improvement in the ulcer area and volume of the rats in Comparative Example 5, but it could not reach the level of the positive drug group and showed a significant difference from the positive drug group.

[0070] In Comparative Example 6, replacing Cordyceps militaris with Ophiopogon japonicus resulted in some improvement in ulcer area and volume in the rats of Comparative Example 6, but it could not reach the level of the positive drug group and showed a significant difference from the positive drug group.

[0071] Comparative Example 7 altered the dosage relationship between phosphatidylcholine and soybean oligosaccharides, resulting in their inability to effectively synergize with the Chinese medicine components. Although the ulcer area and volume of rats in Comparative Example 7 were improved, they could not reach the level of the positive drug group and showed significant differences from the positive drug group.

[0072] In Examples 1-3 of this invention, specific amounts of Loropetalum chinense, Cordyceps militaris, and Dioscorea opposita were used to achieve a synergistic effect. In addition, specific amounts of phosphatidylcholine and soybean oligosaccharides were used to significantly reduce the ulcer area and volume in rats, reaching a level lower than that of the positive control group, and showing a significant difference from the positive control group.

[0073] The technical effects of embodiments 4-6 of the present invention are equivalent to those of embodiment 3.

[0074] IV. Cisplatin-induced chemotherapy-induced vomiting in rats 1. Experimental Methods (1) Male SPF rats were randomly divided into a blank control group, a cisplatin model group, a positive control group, and a test drug treatment group, with 8 rats in each group. The blank control group and the cisplatin model group were administered water for injection by gavage, while the positive control group and the test drug treatment group were administered ondansetron 1.3 mg / kg and the test drug 1.5 g / kg by gavage, respectively. The gavage volume for each group was 2 mL / 100 g body weight. The rats were administered the drug twice a day at 12 h intervals, for 3 consecutive days.

[0075] (2) One hour after the first administration, the cisplatin model group, the positive drug treatment group and the test drug treatment group were intraperitoneally injected with cisplatin 6 mg / kg to establish a chemotherapeutic rat vomiting model, while the blank control group was intraperitoneally injected with an equal volume of physiological saline.

[0076] The average total number of vomiting episodes in each group of rats was recorded within 72 hours after modeling.

[0077] 2. Experimental Grouping (1) Experimental animals: SPF male rats, weighing 200-250g, 8 rats per group.

[0078] (2) Grouping: blank control group, cisplatin model group, test substance treatment group and positive drug treatment group. Among them, the test substance is the composition prepared in Examples 1-3 and Comparative Examples 1-7, and the positive drug is ondansetron.

[0079] 3. Experimental Results The average total number of vomitings in rats obtained in the experiment is shown in Table 4.

[0080] Table 4

[0081] Note: Different shoulder labels (lowercase English letters) in the same column of data a-f indicate significant differences (P<0.05).

[0082] The Chinese medicine components in Comparative Example 1 consisted only of Loropetalum chinense and Dioscorea opposita; those in Comparative Example 2 consisted only of Cordyceps militaris; those in Comparative Example 3 consisted only of Loropetalum chinense; and those in Comparative Example 4 consisted only of Cordyceps militaris and Dioscorea opposita. Although the number of vomiting episodes in these rats was reduced compared to the cisplatin model group, they could not achieve the effect of the positive control drug.

[0083] Although Comparative Example 5 contained Loropetalum chinense, Cordyceps militaris, and Dioscorea opposita, the change in their dosage relationship resulted in a reduction in the number of vomiting episodes in the rats of Comparative Example 5 compared to the cisplatin model group, but it did not achieve the effect of the positive drug.

[0084] In Comparative Example 6, replacing Cordyceps militaris with Ophiopogon japonicus resulted in a reduction in the number of vomiting episodes in the rats compared to the cisplatin model group, but this did not achieve the effect of the positive control drug.

[0085] Comparative Example 7 altered the dosage relationship between phosphatidylcholine and soybean oligosaccharides, resulting in their inability to effectively synergize with the Chinese medicine components. Although the number of vomiting episodes in Comparative Example 7 rats was reduced compared to the cisplatin model group, it could not achieve the effect of the positive control drug.

[0086] Examples 1-3 of this invention can significantly reduce the number of vomitings in rats caused by cisplatin, and are superior to the positive control drug, showing a significant difference from the positive control drug treatment group.

[0087] The technical effects of embodiments 4-6 of the present invention are equivalent to those of embodiment 3.

[0088] The present invention has been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of the invention. The descriptions of the embodiments above are only for the purpose of helping to understand the invention and its core ideas. It should be noted that those skilled in the art can make various improvements and modifications to the invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims

1. A composition for gastrointestinal mucosal protection after chemotherapy, characterized in that, include: Traditional Chinese medicine components, phosphatidylcholine, and soybean oligosaccharides; The Chinese herbal ingredients are Cordyceps militaris extract, Loropetalum chinense, and Dioscorea opposita.

2. The composition according to claim 1, characterized in that, The mass ratio of Cordyceps militaris extract, Loropetalum chinense and Dioscorea opposita is (37-60):(200-400):(5-42).

3. The composition according to claim 1, characterized in that, The mass ratio of phosphatidylcholine to soybean oligosaccharide is (25-60):(15-60).

4. The composition according to claim 1, characterized in that, The composition comprises, by weight, 240-500 parts of traditional Chinese medicine components, 25-60 parts of phosphatidylcholine and 15-60 parts of soybean oligosaccharides.

5. A method for preparing the composition according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Cordyceps militaris was extracted and dried to obtain Cordyceps militaris extract; Loropetalum chinense was pulverized and Dioscorea opposita was cooked and then pulverized to obtain Loropetalum chinense powder and cooked Dioscorea opposita powder. (2) The Cordyceps militaris extract and phosphatidylcholine were stirred at a constant temperature and sieved to obtain mixture A; (3) Mix the white-flowered Loropetalum powder and cooked yam powder evenly, then add soybean oligosaccharide and continue to mix evenly. Sieve to obtain mixture B; (4) Mix mixture A and mixture B evenly to obtain the final product.

6. A health food product, characterized in that, Includes the composition according to any one of claims 1-4 or the composition prepared by the method according to claim 5.

7. A medicine, characterized in that, Includes the composition according to any one of claims 1-4 or the composition prepared by the method according to claim 5.

8. The use of the composition according to any one of claims 1-4 or the composition prepared by the preparation method according to claim 5 in the preparation of health food for the auxiliary protection of gastrointestinal mucosal injury.

9. The use of the composition according to any one of claims 1-4 or the composition prepared by the method according to claim 5 in the preparation of a medicament for treating gastrointestinal mucosal diseases.

10. The application according to claim 9, characterized in that, The gastrointestinal mucosal diseases mentioned include at least one of the following: gastrointestinal mucosal damage caused by chemotherapy, gastrointestinal mucosal damage after radiotherapy, drug-induced gastrointestinal mucosal damage, combined gastrointestinal mucosal damage caused by combined radiotherapy and chemotherapy, gastrointestinal mucosal damage related to adjuvant drugs such as targeted drugs in tumor treatment, chemotherapy-related gastrointestinal mucosal inflammation and ulcers, mucosal damage caused by radiation enteritis / gastritis, and gastrointestinal mucosal lesions caused by nonsteroidal anti-inflammatory drugs and antibiotics.

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