Composition for relieving gastrointestinal tumor treatment discomfort

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a composition for relieving gastrointestinal tumor treatment discomfort. The composition comprises nutritional ingredients and functional ingredients, wherein the nutritional ingredients comprise a first nutritional ingredient, a second nutritional ingredient and a third nutritional ingredient; the first nutritional ingredient is prepared from the following components: 5-hydroxytryptamine, ethanolamine, beta-hydroxy-beta-methylbutyric acid and acetoacetyl coenzyme A; the second nutritional ingredient is prepared from the following components: poria cocos exosome, carrot exosome, ginger exosome, oat exosome, tomato exosome and donkey-hide gelatin exosome; and the third nutritional ingredient consists of the following components: glucose, brown rice protein powder, fish oil microcapsule powder, xylooligosaccharide, nicotinamide, riboflavin and L-carnitine. The composition can effectively improve symptoms such as nausea, vomiting, fatigue and weakness of gastrointestinal tumor postoperative patients, can comprehensively supplement nutrients required by the patients, and can promote rehabilitation of the patients.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine and relates to a composition for relieving discomfort during the treatment of gastrointestinal tumors. Background Art

[0002] Gastrointestinal tumors are one of the common malignant tumors globally, with relatively high incidence and mortality rates. During the treatment process, patients often experience a series of discomfort symptoms, especially after undergoing surgery, radiotherapy, or chemotherapy. These discomfort symptoms include, but are not limited to, nausea, vomiting, fatigue, weakness, and malnutrition, etc. These symptoms not only seriously affect the quality of life of patients but may also hinder the smooth progress of treatment and the recovery process of patients.

[0003] Traditional treatment methods often focus on tumor resection and disease control, but pay less attention to the quality of life and symptom management of patients after surgery. In addition, although existing drugs and nutritional supplements can relieve these symptoms to a certain extent, they often have problems such as poor effect or single effect. Patients often need to take multiple drugs or large amounts of drugs to relieve various discomfort symptoms after surgery, which will cause a serious burden on the physical and mental health of patients.

[0004] Therefore, in the technical field of traditional Chinese medicine, it is particularly important to provide a composition for relieving various discomfort symptoms during the treatment of gastrointestinal tumors and with obvious relief effects. Summary of the Invention

[0005] The purpose of the present invention is to provide a composition for relieving discomfort during the treatment of gastrointestinal tumors. This composition aims to effectively improve symptoms such as nausea, vomiting, fatigue, and weakness in patients after gastrointestinal tumor surgery through the combination of specific nutritional components and functional components, and can comprehensively supplement the nutrients required by patients, promote the recovery of patients, thereby improving the quality of life of patients.

[0006] To achieve the above purpose, the technical solution of the present invention is as follows:

[0007] In the first aspect, the present invention provides a composition for relieving discomfort during the treatment of gastrointestinal tumors. The composition includes nutritional components and functional components. The nutritional components include a first nutritional component, a second nutritional component, and a third nutritional component; wherein,

[0008] The first nutritional component is composed of the following components: 5 - hydroxytryptamine, ethanolamine, β - hydroxy - β - methylbutyric acid, and acetoacetyl coenzyme A;

[0009] The second nutritional component is composed of the following components: poria exosomes, carrot exosomes, ginger exosomes, oat exosomes, tomato exosomes, and donkey - hide gelatin exosomes;

[0010] The third nutrient component is composed of the following components: glucose, brown rice protein powder, fish oil microcapsule powder, xylo-oligosaccharide, niacinamide, riboflavin, and L-carnitine.

[0011] Preferably, the efficacy components include a first efficacy component, a second efficacy component, and a third efficacy component; wherein,

[0012] The first efficacy component is composed of the following components: Pinellia ternata, Pogostemon cablin, Perilla frutescens, Citrus reticulata Blanco, and Evodia rutaecarpa;

[0013] The second efficacy component is composed of the following components: Dioscorea opposita, Angelica sinensis, Carthamus tinctorius, Ophiopogon japonicus, and Tremella fuciformis;

[0014] The third efficacy component is composed of the following components: Medicated leaven, Amomum villosum, Pseudostellaria heterophylla, Paris polyphylla, and Tsaoko fruit.

[0015] Preferably, the weight ratio of the first nutrient component, the second nutrient component, and the third nutrient component is 0.3-0.8:0.5-1:1.

[0016] Preferably, the weight ratio of the first efficacy component, the second efficacy component, and the third efficacy component is 1:1:1.

[0017] Preferably, by weight,

[0018] The first nutrient component is composed of the following components: 0.5-2 parts of 5-hydroxytryptamine, 1-1.5 parts of ethanolamine, 0.5-1 part of β-hydroxy-β-methylbutyric acid, and 1-2 parts of acetoacetyl coenzyme A;

[0019] The second nutrient component is composed of the following components: 0.3-0.5 parts of Poria cocos exosomes, 0.5-1 part of carrot exosomes, 0.2-0.5 parts of ginger exosomes, 1-1.5 parts of oat exosomes, 1-2 parts of tomato exosomes, and 0.5-1 part of donkey-hide gelatin exosomes;

[0020] The third nutrient component is composed of the following components: 5-7 parts of glucose, 15-18 parts of brown rice protein powder, 15-17 parts of fish oil microcapsule powder, 5-7 parts of xylo-oligosaccharide, 0.5-1 part of niacinamide, 0.5-1 part of riboflavin, and 2-5 parts of L-carnitine.

[0021] Preferably, by weight,

[0022] The first efficacy component is composed of the following components: 2-5 parts of Pinellia ternata, 10-15 parts of Pogostemon cablin, 5-8 parts of Perilla frutescens, 4-6 parts of Citrus reticulata Blanco, and 10-12 parts of Evodia rutaecarpa;

[0023] The second efficacy component is composed of the following components: 5-10 parts of Dioscorea opposita, 5-7 parts of Angelica sinensis, 8-10 parts of Carthamus tinctorius, 3-6 parts of Ophiopogon japonicus, and 6-9 parts of Tremella fuciformis;

[0024] The third active ingredient consists of the following components: 2 - 5 parts of medicated leaven, 10 - 13 parts of amomum villosum, 5 - 8 parts of pseudostellaria heterophylla, 6 - 8 parts of paris vietnamensis, and 3 - 7 parts of tsaoko fruit.

[0025] Preferably, the weight ratio of the nutrient component to the active ingredient is 1:0.5 - 0.8.

[0026] In a second aspect, there is provided a pharmaceutical preparation made from the composition of the present invention and pharmaceutically acceptable excipients.

[0027] In a third aspect, there is provided a method for preparing the composition of the present invention, the preparation method comprising the following steps:

[0028] Prepare the first nutrient component, the second nutrient component, and the third nutrient component respectively, and obtain the nutrient component after mixing according to the ratio;

[0029] Prepare the first active ingredient, the second active ingredient, and the third active ingredient respectively, and obtain the active ingredient after mixing according to the ratio;

[0030] Mix the nutrient component and the active ingredient according to the ratio to obtain the composition.

[0031] In a fourth aspect, there is provided the use of the composition of the present invention in the preparation of any one of the following preparations:

[0032] 1) A preparation for preventing and treating recurrence and metastasis after gastrointestinal tumor surgery;

[0033] 2) A preparation for improving the clinical symptoms of patients after gastrointestinal tumor surgery, the clinical symptoms including one or more of nausea and vomiting, fatigue and weakness, and malnutrition;

[0034] 3) A preparation for improving the quality of life of patients after gastrointestinal tumor surgery.

[0035] Preferably, the dosage form of the preparation is any one of tablets, oral liquids, granules, capsules, decoction extracts, pills, powders, lozenges, fluid extracts, extracts, injections, and syrups.

[0036] In a fifth aspect, there is provided a functional food comprising a safe and effective amount of the composition as described in the present invention.

[0037] In the present invention, the raw materials / Chinese medicinal materials used have the following effects / pharmacological effects:

[0038] Pinellia: The dried tuber of Pinellia ternata (Thunb.) Breit., Araceae. It has the effects of drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting, dissipating binds and resolving masses, and is used to treat damp phlegm, cold phlegm, cough with profuse phlegm, dizziness due to phlegm retention, wind phlegm dizziness, headache due to phlegm syncope, vomiting and nausea, stuffiness and discomfort in the chest and diaphragm, globus hystericus, etc. Modern pharmacology shows that Pinellia mainly contains chemical components such as alkaloids, volatile oils, organic acids, sterols, amino acids, and inorganic elements, and can relieve cough and reduce phlegm, suppress vomiting, resist early pregnancy, prevent ulcer, anti-tumor, lower blood lipid, and lower blood pressure.

[0039] Agastache rugosa (Fisch. ex O. Ktze.) O. Ktze.: It has a pungent taste, is slightly warm in nature, and is non-toxic. It mainly treats wind-water edema, expels foul qi, stops cholera, and relieves epigastric pain. It is an important herb for treating vomiting due to disharmony of the spleen and stomach. At the same time, it can also promote the function of the stomach qi, improve the appetite, and increase food intake. It also has a therapeutic effect on symptoms such as deficiency-cold of the lung, excessive heat in the upper energizer, and bad breath after drinking. In addition, Agastache rugosa is known as the best herb for aromatic dampness elimination and has the reputation of "righteous qi".

[0040] Perilla leaf: It is recorded in "Shennong Ben Cao Jing" that Perilla leaf (Perilla frutescens (L.) Britt. var. acuta (Thunb.) Kudo) has a pungent taste, is slightly warm and non-toxic, and mainly enters the lung and spleen meridians. It helps to eliminate flatulence in the gastrointestinal tract and promote digestion.

[0041] Tangerine peel: It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm, and is used for fullness and distension in the chest and abdomen, anorexia, vomiting and diarrhea, cough with profuse phlegm.

[0042] Evodia rutaecarpa (Juss.) Benth.: It has the effects of dispersing cold and relieving pain, lowering adverse qi and stopping vomiting, and helping yang to stop diarrhea, and is used for headache due to cold in Jueyin meridian, abdominal pain due to cold hernia, beriberi due to cold-dampness, abdominal pain during menstruation, abdominal distension and pain, vomiting and acid regurgitation, diarrhea at the fifth watch.

[0043] Chinese yam: In "Shennong Ben Cao Jing", Chinese yam is also called Dioscorea opposita Thunb.. It can treat symptoms such as loss of appetite and indigestion caused by weakness of the spleen and stomach. It has a tonic effect and can improve symptoms such as physical weakness and emaciation. It can disperse cold and heat pathogens in the body and balance yin and yang. It can enhance the function of the spleen and stomach and improve the body's anti-fatigue ability. It helps to promote muscle growth and improve symptoms such as muscle atrophy.

[0044] Angelica sinensis (Oliv.) Diels: It has a sweet, pungent taste, is warm in nature, and belongs to the liver, heart, and spleen meridians. In "Shennong Ben Cao Jing", Angelica sinensis mainly treats cough with dyspnea, malaria, chills and fevers, and skin diseases (the pronunciation of "xi" is the same as "xuan"). For women with uterine bleeding and infertility, and various traumatic ulcers and metal injuries. Boil it and drink. It nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes defecation. "Compendium of Materia Medica" states that it mainly treats fever due to blood deficiency, fatigue, spontaneous sweating, night sweating, bleeding, chronic dysentery, constipation, abdominal pain. Modern pharmacological research on traditional Chinese medicine has proved that Angelica polysaccharide can promote bone marrow hematopoiesis function, enhance immunity, anti-tumor, anti-inflammatory and protect the liver.

[0045] Safflower: Pungent and warm in nature. It acts on the heart and liver meridians. According to "Ben Jing Feng Yuan", blood is produced in the pericardium, stored in the liver, and belongs to Chong and Ren meridians. Therefore, it can promote blood circulation in men, dredge menstruation in women, activate blood circulation, relieve the toxicity of pox, and disperse red swelling. Entering the blood aspect, it can activate blood circulation to remove stasis, dredge meridians to resolve stagnation, and is used for measles with dark color and poor eruption caused by excessive heat in blood and stagnation of heat and blood, as well as amenorrhea due to blood stasis, postpartum stasis obstruction, mass accumulation, traumatic injury, and unsmooth eruption of measles. Modern pharmacological research on traditional Chinese medicine has proved that safflower has the effects of regulating immune function, analgesia, reducing blood pressure, lipid-lowering, anti-inflammatory, anti-platelet aggregation, enhancing the body's ability to tolerate hypoxia, and helping sleep.

[0046] Ophiopogon japonicus: Sweet, slightly bitter, and slightly cold in nature. It acts on the heart, lung, and stomach meridians. "Shen Nong Ben Cao Jing" records that it "is mainly used for treating chest and abdominal qi stagnation, injury to the middle qi due to overeating, blockage of the gastric collaterals, emaciation, and shortness of breath. Taking it for a long time can make the body light, prevent aging, and avoid hunger." It has the effects of nourishing yin and promoting fluid production, moistening the lungs and clearing the heart. It is mainly used to treat symptoms such as dry cough due to lung dryness, spitting blood, lung abscess, consumptive fever, thirst, fluid injury caused by febrile diseases, dryness and thirst in the throat, and constipation. Modern pharmacological research on traditional Chinese medicine has proved that Ophiopogon japonicus has the effect of protecting the cardiovascular system; enhancing the tolerance to hypoxia and prolonging the survival time under normal pressure hypoxia; enhancing immune function; reducing blood sugar; delaying aging; inhibiting gastrointestinal propulsion; and antibacterial.

[0047] Tremella fuciformis: Neutral in nature and sweet in taste, it acts on the heart, lung, kidney, and stomach meridians. It can clear heat pathogens in the lungs and improve symptoms such as cough due to lung heat. It can moisten the kidneys and improve the dryness symptoms caused by deficiency of kidney yin. It helps to calm the mind and improve symptoms such as palpitation and insomnia. It can tonify qi and blood and improve symptoms such as pale complexion and fatigue caused by deficiency of both qi and blood. In the record of "Compendium of Materia Medica" in the Ming Dynasty, Tremella fuciformis emphasized its effects of moistening the lungs to promote fluid production, nourishing yin and invigorating the stomach.

[0048] Medicated leaven: It is a fermented preparation made by adding drugs such as Polygonum hydropiper, Artemisia annua, and almonds to flour. It has the effects of strengthening the spleen and stomach, promoting digestion and regulating the middle energizer, and is used to treat weakness of the spleen and stomach, indigestion, vomiting, diarrhea, etc. Modern pharmacology shows that medicated leaven mainly contains chemical components such as digestive enzymes, volatile oils, and glycosides, and can promote the secretion of digestive juices and improve intestinal flora imbalance.

[0049] Amomum villosum: It is a large-scale medicinal material that can be used both as medicine and food, and has various effects such as promoting qi circulation to regulate the middle energizer, tonifying the lungs and kidneys, and harmonizing the stomach to arouse the spleen. It can be used to treat symptoms such as abdominal pain and distension, dysphagia and vomiting, cough with qi surging, etc., and can also be used to treat diseases such as dysentery with red and white mucus, cholera with cramps, and running piglet syndrome with metrorrhagia and leukorrhagia.

[0050] Pseudostellaria heterophylla: It has the effects of replenishing qi to strengthen the spleen and promoting fluid production to moisten the lungs, and has good effects on treating symptoms such as weakness of the spleen, loss of appetite, and weakness after illness.

[0051] Paris polyphylla: Bitter in taste and slightly cold in nature, slightly poisonous, it acts on the liver meridian, and is good at clearing and discharging heat toxins, relieving snake venom, and reducing swelling and pain. Paris polyphylla has the effects of clearing heat and detoxifying, reducing swelling and pain, cooling the liver and calming convulsions. It is commonly used to treat furuncles, carbuncles, snake bites, sore throat, and infantile convulsions.

[0052] Amomum tsaoko: The dried ripe fruit of Amomum tsaoko Crevost et Lemarie, Zingiberaceae family. It has the effects of drying dampness and warming the middle-jiao, intercepting malaria and eliminating phlegm, and is used for treating internal obstruction of cold-dampness, abdominal distension and pain, fullness and stuffiness with vomiting, malaria with chills and fever, pestilence fever, etc. Modern pharmacology shows that Amomum tsaoko mainly contains chemical components such as volatile oils, polyphenols, diphenylheptanes, bicyclic nonanes, and sterols, and can regulate gastrointestinal dysfunction, antioxidize, antibacterial, anti-tumor, lose weight, reduce lipid, and lower blood sugar, etc.

[0053] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0054] (1) The composition provided by the present invention contains a variety of specific nutritional components, specifically, a first nutritional component composed of serotonin, ethanolamine, β-hydroxy-β-methylbutyric acid, and acetoacetyl coenzyme A, a second nutritional component composed of poria exosomes, carrot exosomes, ginger exosomes, oat exosomes, tomato exosomes, and donkey-hide gelatin exosomes, and a third nutritional component composed of glucose, brown rice protein powder, fish oil microcapsule powder, xylo-oligosaccharide, niacinamide, riboflavin, and L-carnitine. These components act together in the patient's body to provide comprehensive and balanced nutritional support for the patient, and at the same time, can relieve symptoms such as nausea, vomiting, fatigue, and weakness in patients after gastrointestinal tumor surgery, and promote the recovery of the patient.

[0055] (2) The composition provided by the present invention also contains a variety of specific efficacy components, specifically, a first efficacy component composed of Pinellia ternata, Agastache rugosa, Perilla frutescens, Citrus reticulata Blanco, and Evodia rutaecarpa, a second efficacy component composed of Dioscorea opposita, Angelica sinensis, Carthamus tinctorius, Ophiopogon japonicus, and Tremella fuciformis, and a third efficacy component composed of Medicated Leaven, Amomum villosum, Pseudostellaria heterophylla, Paris polyphylla, and Amomum tsaoko. These components can specifically relieve symptoms such as nausea, vomiting, fatigue, weakness, and malnutrition in patients after gastrointestinal tumor surgery through the compatibility principle of traditional Chinese medicine theory, and improve the quality of life of the patients.

[0056] (3) The composition of the present invention is prepared from efficacy components and nutritional components composed of natural medicinal materials, which is safe and has no side effects. At the same time, through reasonable formula design and preparation process, the cost is moderate, which is easy for patients to accept and use.

[0057] (4) The composition provided by the present invention, through the synergistic effect of nutritional components and efficacy components, as well as the overall balance and regulation, these components interact with each other in the human body to jointly regulate the physiological functions of patients. While providing comprehensive nutrition for patients, it can effectively relieve symptoms such as nausea, vomiting, fatigue, and weakness in patients after gastrointestinal tumor surgery, and can also avoid side effects. The applicant speculates that it may be due to: First, the first nutritional component may help regulate neurotransmitters and energy metabolism, thereby reducing the patient's fatigue and weakness. At the same time, the second efficacy component can reduce the fatigue and weakness caused by physical consumption, anemia, or psychological factors caused by treatment; the combination of the first nutritional component and the second efficacy component further reduces the fatigue and weakness caused by internal and external factors in patients. Second, the second nutritional component has a unique bilayer membrane structure, rich bioactive substances, and various bioactive functions. This bilayer membrane structure, bioactive substances, and bioactive functions help promote intestinal health, enhance immunity, and may have an anti-inflammatory effect, thereby reducing the side effects of tumor treatment on the gastrointestinal tract; the combination of the second nutritional component and the first efficacy component can effectively relieve nausea and vomiting caused by abnormal gastrointestinal motility. Third, the third nutritional component helps to overall regulate the nutritional status of patients; at the same time, cooperating with the third efficacy component is more helpful to improve gastrointestinal function, promote digestion and absorption, thereby reducing the occurrence of malnutrition.

[0058] (5) The composition of the present invention can be prepared into various dosage forms, such as tablets, granules, pills, powders, ointments, capsules, extracts, or powders, etc., which is convenient for patients to choose a suitable dosage form for use according to their own conditions. Detailed implementation manners

[0059] The following will specifically describe the present invention in combination with specific implementation manners and examples, and the advantages and various effects of the present invention will be presented more clearly therefrom. Those skilled in the art should understand that these specific implementation manners and examples are used to illustrate the present invention, rather than to limit the present invention.

[0060] Next, the technical solutions of the present invention will be described in combination with examples. However, the present invention is not limited to the following examples. The experimental methods and detection methods described in each example are all conventional methods unless otherwise specified; the reagents and materials described are all commercially available unless otherwise specified.

[0061] In the embodiment of the present invention, the fish oil microcapsule powder is purchased from Xi'an Tuofeng Biotechnology Co., Ltd., and the product number is tfsw0214.

[0062] In the embodiment of the present invention, the preparation method of poria exosomes is as follows:

[0063] ① Add 300 mL of sterile normal saline to 260 g of fresh Poria cocos, and use a crusher to crush it until a uniform paste is formed; centrifuge the crushed paste at 5 °C and 3500×g for 30 min to remove larger particles of impurities, and take the transparent solution in the middle layer;

[0064] ② Centrifuge the transparent solution obtained in step ① at 5 °C and 10000×g for 40 min, and take the upper-layer solution;

[0065] ③ Centrifuge the upper-layer solution obtained in step ② at 5 °C and 100000×g for 50 min, then resuspend the precipitate with 3 mL of sterile normal saline and centrifuge at 5 °C and 120000×g for 60 min, and resuspend the precipitate with 3 mL of sterile normal saline again to obtain Poria cocos exosomes.

[0066] In the embodiment of the present invention, the preparation method of carrot exosomes is as follows:

[0067] ① Add 350 mL of ethyl acetate to 250 g of fresh carrots, and use a crusher to crush it until a uniform paste is formed; centrifuge the crushed paste at 5 °C and 3500×g for 35 min to remove larger residues and impurities, and take the light yellow transparent solution in the middle layer;

[0068] ② Centrifuge the light yellow transparent solution obtained in step ① at 5 °C and 10000×g for 50 min, and take the supernatant;

[0069] ③ Centrifuge the supernatant obtained in step ② at 5 °C and 100000×g for 55 min, then resuspend the precipitate with 3 mL of ethyl acetate and centrifuge at 5 °C and 120000×g for 60 min, and resuspend the precipitate with 3 mL of ethyl acetate again to obtain carrot exosomes.

[0070] In the embodiment of the present invention, the preparation method of ginger exosomes is as follows:

[0071] ① Add 300 mL of sterilized water to 260 g of fresh ginger, and use a crusher to crush it until a uniform paste is formed; centrifuge the crushed paste at 5 °C and 3000×g for 40 min to remove larger residues and impurities, and take the light yellow transparent solution in the middle layer;

[0072] ② Centrifuge the light yellow transparent solution obtained in step ① at 5 °C and 10000×g for 40 min, and take the supernatant;

[0073] ③ Centrifuge the supernatant obtained in step ② at 5 °C and 100000×g for 50 min, then resuspend the precipitate with 3 mL of sterile water and centrifuge at 5 °C and 120000×g for 55 min, and resuspend the precipitate with 3 mL of sterile water again to obtain ginger exosomes.

[0074] In the embodiments of the present invention, the preparation method of oat exosomes is as follows:

[0075] ① Add 350 mL of acetone to 300 g of fresh oats, and use a crusher to crush until a uniform paste is formed; centrifuge the crushed paste at 5°C and 3000×g for 40 min to remove larger residues and impurities, and take the light yellow transparent solution in the middle layer;

[0076] ② Centrifuge the light yellow transparent solution obtained in step ① at 5°C and 10000×g for 50 min, and take the supernatant;

[0077] ③ Centrifuge the supernatant obtained in step ② at 5°C and 100000×g for 55 min, then resuspend the precipitate with 5 mL of acetone and centrifuge at 5°C and 120000×g for 65 min, and resuspend the precipitate with 5 mL of acetone again to obtain oat exosomes.

[0078] In the embodiments of the present invention, the preparation method of tomato exosomes is as follows:

[0079] ① Add 300 mL of acetone to 260 g of fresh tomatoes, and use a crusher to crush until a uniform paste is formed; centrifuge the crushed paste at 5°C and 3000×g for 40 min to remove larger residues and impurities, and take the orange-yellow transparent solution in the middle layer;

[0080] ② Centrifuge the orange-yellow transparent solution obtained in step ① at 5°C and 10000×g for 45 min, and take the supernatant;

[0081] ③ Centrifuge the supernatant obtained in step ② at 5°C and 120000×g for 50 min, then resuspend the precipitate with 3 mL of acetone and centrifuge at 5°C and 120000×g for 55 min, and resuspend the precipitate with 3 mL of acetone again to obtain tomato exosomes.

[0082] In the embodiments of the present invention, the preparation method of donkey-hide gelatin exosomes is as follows:

[0083] ① Add 300 mL of sterile water to 260 g of fresh donkey-hide gelatin, and use a crusher to crush until a uniform paste is formed; centrifuge the crushed paste at 5°C and 3000×g for 40 min to remove larger residues and impurities, and take the colorless transparent solution in the middle layer;

[0084] ② Centrifuge the colorless transparent solution obtained in step ① at 5°C and 10000×g for 50 min, and take the supernatant;

[0085] ③ Centrifuge the supernatant obtained in step ② at 5°C and 120000×g for 55 min, then resuspend the precipitate with 5 mL of sterile water and centrifuge at 5°C and 150000×g for 60 min, and resuspend the precipitate with 5 mL of sterile water again to obtain donkey-hide gelatin exosomes.

[0086] Example 1

[0087] This example provides a composition for alleviating discomfort during gastrointestinal tumor treatment. The composition includes nutritional components and efficacy components, and the weight ratio of the nutritional components to the efficacy components is 1:0.5.

[0088] The nutritional components include a first nutritional component, a second nutritional component, and a third nutritional component; the weight ratio of the first nutritional component, the second nutritional component, and the third nutritional component is 0.3:0.5:1.

[0089] Among them, by weight,

[0090] The first nutritional component consists of the following components: 0.5 parts of 5-hydroxytryptamine, 1 part of ethanolamine, 0.5 part of β-hydroxy-β-methylbutyric acid, and 1 part of acetoacetyl coenzyme A.

[0091] The second nutritional component consists of the following components: 0.3 part of Poria cocos exosomes, 0.5 part of carrot exosomes, 0.2 part of ginger exosomes, 1 part of oat exosomes, 1 part of tomato exosomes, and 0.5 part of donkey-hide gelatin exosomes.

[0092] The third nutritional component consists of the following components: 5 parts of glucose, 15 parts of brown rice protein powder, 15 parts of fish oil microcapsule powder, 5 parts of xylo-oligosaccharide, 0.5 part of nicotinamide, 0.5 part of riboflavin, and 2 parts of L-carnitine.

[0093] The efficacy components include a first efficacy component, a second efficacy component, and a third efficacy component; the weight ratio of the first efficacy component, the second efficacy component, and the third efficacy component is 1:1:1.

[0094] Among them, by weight,

[0095] The first efficacy component consists of the following components: 2 parts of Pinellia ternata, 10 parts of Pogostemon cablin, 5 parts of Perilla leaf, 4 parts of Citrus reticulata peel, and 10 parts of Evodia rutaecarpa.

[0096] The second efficacy component consists of the following components: 5 parts of Dioscorea opposita, 5 parts of Angelica sinensis, 8 parts of Carthamus tinctorius, 3 parts of Ophiopogon japonicus, and 6 parts of Tremella fuciformis.

[0097] The third efficacy component consists of the following components: 2 parts of Medicated leaven, 10 parts of Amomum villosum, 5 parts of Pseudostellaria heterophylla, 6 parts of Paris polyphylla, and 3 parts of Tsaoko fruit.

[0098] Example 2

[0099] This example provides a composition for alleviating discomfort during gastrointestinal tumor treatment. The composition includes nutritional components and efficacy components, and the weight ratio of the nutritional components to the efficacy components is 1:0.8.

[0100] The nutrient components include a first nutrient component, a second nutrient component, and a third nutrient component; the weight ratio of the first nutrient component, the second nutrient component, and the third nutrient component is 0.8:1:1;

[0101] Among them, by weight,

[0102] The first nutrient component consists of the following components: 2 parts of 5-hydroxytryptamine, 1.5 parts of ethanolamine, 1 part of β-hydroxy-β-methylbutyric acid, and 2 parts of acetoacetyl coenzyme A;

[0103] The second nutrient component consists of the following components: 0.5 part of Poria cocos exosomes, 1 part of carrot exosomes, 0.5 part of ginger exosomes, 1.5 parts of oat exosomes, 2 parts of tomato exosomes, and 1 part of donkey-hide gelatin exosomes;

[0104] The third nutrient component consists of the following components: 7 parts of glucose, 18 parts of brown rice protein powder, 17 parts of fish oil microcapsule powder, 7 parts of xylo-oligosaccharide, 1 part of nicotinamide, 1 part of riboflavin, and 5 parts of L-carnitine;

[0105] The efficacy components include a first efficacy component, a second efficacy component, and a third efficacy component; the weight ratio of the first efficacy component, the second efficacy component, and the third efficacy component is 1:1:1;

[0106] Among them, by weight,

[0107] The first efficacy component consists of the following components: 5 parts of Pinellia ternata, 15 parts of Agastache rugosa, 8 parts of Perilla frutescens, 6 parts of Citrus reticulata Blanco, and 12 parts of Evodia rutaecarpa;

[0108] The second efficacy component consists of the following components: 10 parts of Dioscorea opposita, 7 parts of Angelica sinensis, 10 parts of Carthamus tinctorius, 6 parts of Ophiopogon japonicus, and 9 parts of Tremella fuciformis;

[0109] The third efficacy component consists of the following components: 5 parts of Medicated leaven, 13 parts of Amomum villosum, 8 parts of Pseudostellaria heterophylla, 8 parts of Paris polyphylla, and 7 parts of Tsaoko fruit.

[0110] Example 3

[0111] This example provides a composition for relieving discomfort during gastrointestinal tumor treatment. The composition includes nutrient components and efficacy components, and the weight ratio of the nutrient components to the efficacy components is 1:0.6;

[0112] The nutrient components include a first nutrient component, a second nutrient component, and a third nutrient component; the weight ratio of the first nutrient component, the second nutrient component, and the third nutrient component is 0.5:0.5:1;

[0113] Among them, by weight,

[0114] The first nutrient component consists of the following components: 1 part of serotonin, 1 part of ethanolamine, 0.5 part of β-hydroxy-β-methylbutyric acid, and 1.5 parts of acetoacetyl coenzyme A;

[0115] The second nutrient component consists of the following components: 0.3 part of Poria cocos exosomes, 0.5 part of carrot exosomes, 0.5 part of ginger exosomes, 1 part of oat exosomes, 1 part of tomato exosomes, and 1 part of donkey-hide gelatin exosomes;

[0116] The third nutrient component consists of the following components: 6 parts of glucose, 16 parts of brown rice protein powder, 15 parts of fish oil microcapsule powder, 6 parts of xylo-oligosaccharide, 1 part of niacinamide, 1 part of riboflavin, and 3 parts of L-carnitine;

[0117] The active components include a first active component, a second active component, and a third active component; the weight ratio of the first active component, the second active component, and the third active component is 1:1:1;

[0118] Among them, by weight,

[0119] The first active component consists of the following components: 3 parts of Pinellia ternata, 11 parts of Agastache rugosa, 6 parts of Perilla frutescens, 5 parts of Citrus reticulata Blanco, and 11 parts of Evodia rutaecarpa;

[0120] The second active component consists of the following components: 6 parts of Dioscorea opposita, 6 parts of Angelica sinensis, 9 parts of Carthamus tinctorius, 5 parts of Ophiopogon japonicus, and 7 parts of Tremella fuciformis;

[0121] The third active component consists of the following components: 3 parts of Medicated Leaven, 11 parts of Amomum villosum, 6 parts of Pseudostellaria heterophylla, 7 parts of Paris polyphylla, and 5 parts of Tsaoko fruit.

[0122] Example 4

[0123] This example provides a preparation method of a granule of a composition for relieving discomfort during gastrointestinal tumor treatment, and the preparation method includes the following steps:

[0124] Respectively prepare the first nutrient component, the second nutrient component, and the third nutrient component, and obtain the nutrient component after mixing according to the ratio;

[0125] Respectively prepare the first active component, the second active component, and the third active component, and obtain the active component after mixing according to the ratio;

[0126] Mix the nutrient component and the active component evenly according to the ratio to obtain a material, which is the composition;

[0127] Add an appropriate amount of starch paste to the evenly mixed material, and make wet granules through a high-speed rotary granulator; place the wet granules in an oven for drying, and size the dried granules through a sieve to remove too large or too small granules to obtain uniform granules;

[0128] Among them, on the basis of determining the components of the first nutrient component, the second nutrient component, and the third nutrient component, the preparation processes of the first nutrient component, the second nutrient component, and the third nutrient component can be easily determined. Similarly, on the basis of determining the components of the first efficacy component, the second efficacy component, and the third efficacy component, the preparation processes of the first efficacy component, the second efficacy component, and the third efficacy component can be easily determined.

[0129] Example 5

[0130] The present example provides a preparation method for a composition for relieving discomfort during gastrointestinal tumor treatment, and the preparation method includes the following steps:

[0131] Separate the first nutrient component, the second nutrient component, and the third nutrient component, and obtain a nutrient component after mixing them in proportion;

[0132] Separate the first efficacy component, the second efficacy component, and the third efficacy component, and obtain an efficacy component after mixing them in proportion;

[0133] Mix the nutrient component and the efficacy component evenly in proportion to obtain a material, which is the composition.

[0134] Comparative Example 1

[0135] This comparative example is the same as Example 3, except that: acetoacetyl coenzyme A in the first nutrient component is replaced with pyruvic acid.

[0136] Comparative Example 2

[0137] This comparative example is the same as Example 3, except that: pinellia ternata in the first efficacy component is replaced with magnolia officinalis.

[0138] Comparative Example 3

[0139] This comparative example is the same as Example 3, except that: the first efficacy component is not added.

[0140] Comparative Example 4

[0141] This comparative example is the same as Example 3, except that: the first nutrient component is not added.

[0142] Experiment 1

[0143] I. Case Selection

[0144] Pathological diagnosis: 210 patients diagnosed with gastrointestinal tumors through pathological examinations were randomly divided into seven groups, with 30 patients in each group, namely Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group; there were no significant differences in the distribution of different genders, different ages, and different disease courses among the seven groups through statistical tests, indicating that the clinical data between the two groups were comparable.

[0145] Inclusion criteria: (1) Patients with gastrointestinal tumors confirmed by pathological / cytological examination and who had undergone chemotherapy; (2) Aged 20-80 years, regardless of gender; (3) Expected survival period > 6 months; (4) Informed consent to participate in this study and signed the informed consent form.

[0146] Exclusion criteria: (1) patients with severe heart, liver, or kidney dysfunction; (2) patients with a second malignant tumor; (3) patients with blood system diseases or severe infections; (4) breastfeeding women; (5) patients with mental disorders who are unable to cooperate; and (6) patients with allergic constitutions or allergies to multiple drugs.

[0147] 2. Treatment Plan

[0148] Test samples: Examples 1-3 and Comparative Examples 1-4, granules of the composition for relieving discomfort in the treatment of gastrointestinal tumors prepared according to the preparation method of Example 4;

[0149] Dosage method: Seven groups took corresponding test samples on the basis of conventional treatment, i.e., Example 1 group took granules of the composition of Example 1, Example 2 group took granules of the composition of Example 2, Example 3 group took granules of the composition of Example 3, Comparative Example 1 group took granules of the composition of Comparative Example 1, Comparative Example 2 group took granules of the composition of Comparative Example 2, Comparative Example 3 group took granules of the composition of Comparative Example 3, and Comparative Example 4 group took granules of the composition of Comparative Example 4; take with water, once a day, at night; take for 2 cycles, each cycle is 21-28 days.

[0150] 3. Treatment Effect

[0151] The manifestations and grading standards (WHO) of clinical chemotherapy toxicity and side effects are shown in Table 1.

[0152] Table 1 Manifestations and grading standards of clinical chemotherapy toxicity and side effects (WHO)

[0153]

[0154] The clinical results after 2 cycles of administration are shown in Table 2.

[0155] Table 2 Clinical results after 2 cycles of treatment

[0156] Experimental group Grade 0 Grade I Grade II Grade III Grade IV Example 1 group 27 3 / / / Example 2 group 28 2 / / / Example 3 group 30 / / / / Comparative Example 1 group 10 7 7 6 / Comparative Example 2 group 8 8 8 6 / Comparative Example 3 group 10 5 7 6 2 Comparative Example 4 group 11 4 8 7 /

[0157] As can be seen from Table 2, the granules of the compositions in Example 1, Example 2, and Example 3 of the present invention can effectively improve the toxic and side effects of nausea, vomiting, fatigue, weakness, and diarrhea in patients with gastrointestinal tumors, and can relieve the discomfort during the treatment of gastrointestinal tumors. Among them, the granules of the composition in Example 3 have the most significant therapeutic effect. The granules of the composition in Example 3 can significantly improve the toxic and side effects of nausea, vomiting, fatigue, weakness, and diarrhea in patients with gastrointestinal tumors, and can significantly relieve the discomfort during the treatment of gastrointestinal tumors. That is, the granules of the compositions in Example 1, Example 2, and Example 3 of the present invention can effectively improve the quality of life of patients with gastrointestinal tumors. However, the granules of the composition that does not adopt the formula system of the present invention have an insignificant effect in relieving the discomfort during the treatment of gastrointestinal tumors and are not suitable as a pharmaceutical preparation for relieving the discomfort during the treatment of gastrointestinal tumors.

[0158] To further prove the beneficial effects of the present invention, the present invention replaces serotonin, ethanolamine, and β-hydroxy-β-methylbutyric acid in the first nutritional component with other substances of similar properties, replaces poria exosomes, carrot exosomes, ginger exosomes, oat exosomes, tomato exosomes, and donkey-hide gelatin exosomes in the second nutritional component with other substances of similar properties, and replaces glucose, brown rice protein powder, fish oil microcapsule powder, xylo-oligosaccharide, niacinamide, riboflavin, and L-carnitine in the third nutritional component with other substances of similar properties. The results show that the clinical results of the granules of the prepared composition are comparable to those of Comparative Example 1 after taking for 2 cycles.

[0159] To further prove the beneficial effects of the present invention, the present invention replaces agastache rugosa, perilla leaf, dried tangerine peel, and evodia rutaecarpa in the first efficacy component with other substances of similar properties, replaces Chinese yam, angelica sinensis, safflower, ophiopogon japonicus, and tremella fuciformis in the second efficacy component with other substances of similar properties, and replaces medicated leaven, amomum villosum, pseudostellaria heterophylla, paris polyphylla, and tsaoko fruit in the third efficacy component with other substances of similar properties. The results show that the clinical results of the granules of the prepared composition are comparable to those of Comparative Example 2 after taking for 2 cycles.

[0160] To further prove the beneficial effects of the present invention, the present invention adjusts the weight ratios of the first nutritional component, the second nutritional component, and the third nutritional component outside the ratios of the present invention, adjusts the weight ratios of the first efficacy component, the second efficacy component, and the third efficacy component outside the ratios of the present invention, adjusts the weight portions of each component in the first nutritional component, the second nutritional component, and the third nutritional component outside the weight portions of the present invention, and adjusts the weight portions of the first efficacy component, the second efficacy component, and the third efficacy component outside the weight portions of the present invention. The results show that the clinical results of the granules of the prepared composition are comparable to those of Comparative Example 2 after taking for 2 cycles.

[0161] Experiment 2

[0162] 1. Case selection

[0163] 280 patients with gastrointestinal tumors complicated with malnutrition during chemotherapy were selected and randomly divided into seven groups, 40 cases in each group, and the average value of each group was taken, namely Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group; the distribution of different genders, different ages, and different courses of disease among the seven groups was not statistically significant after statistical tests, indicating that the clinical data between the two groups are comparable.

[0164] Inclusion criteria: (1) Patients with gastrointestinal tumors confirmed by pathological / cytological examination and who had undergone chemotherapy; (2) Aged 20-80 years, regardless of gender; (3) Expected survival period > 6 months; (4) Informed consent to participate in this study and signed the informed consent form.

[0165] Exclusion criteria: (1) patients with severe heart, liver, or kidney dysfunction; (2) patients with a second malignant tumor; (3) patients with blood system diseases or severe infections; (4) breastfeeding women; (5) patients with mental disorders who are unable to cooperate; and (6) patients with allergic constitutions or allergies to multiple drugs.

[0166] 2. Treatment Plan

[0167] Test samples: Examples 1-3 and Comparative Examples 1-4, granules of the composition for relieving discomfort in the treatment of gastrointestinal tumors prepared according to the preparation method of Example 4;

[0168] Dosage method: Seven groups took corresponding test samples on the basis of conventional treatment, i.e., Example 1 group took granules of the composition of Example 1, Example 2 group took granules of the composition of Example 2, Example 3 group took granules of the composition of Example 3, Comparative Example 1 group took granules of the composition of Comparative Example 1, Comparative Example 2 group took granules of the composition of Comparative Example 2, Comparative Example 3 group took granules of the composition of Comparative Example 3, and Comparative Example 4 group took granules of the composition of Comparative Example 4; take with water, once a day, at night; take for 2 cycles, each cycle is 21-28 days.

[0169] 3. Treatment Effect

[0170] The treatment results of malnourished gastrointestinal tumor patients after taking the drug for 2 cycles are shown in Tables 3 and 4.

[0171] Table 3 Treatment results of malnourished gastrointestinal tumor patients after taking 2 cycles (Example group)

[0172]

[0173]

[0174] Table 4 Treatment Results of Gastrointestinal Tumor Patients with Malnutrition after Taking for 2 Cycles (Control Group)

[0175]

[0176] Albumin level is an important indicator reflecting the degree of malnutrition. Serum albumin is an important indicator reflecting the body's nutritional status and liver synthesis function. Combining body weight and CRP level can truly reflect the patient's nutritional status.

[0177] As can be seen from Table 3, the albumin level, serum albumin, body weight and CRP level of the patients taking the granules of the compositions of Examples 1, 2 and 3 of the present invention tend to improve towards the normal situation. Specifically, the albumin level of the patients before taking showed moderate protein malnutrition, and the albumin level of the patients after taking showed mild protein malnutrition; the serum albumin level of the patients before taking was lower than the normal value, indicating that the patients had malnutrition or impaired liver function, and the serum albumin level of the patients after taking showed a return to the normal level; the CRP level of the patients before taking showed a mild increase, and the CRP level of the patients after taking returned to the normal level; at the same time, the body weight of the patients after taking also increased (gastrointestinal tumor patients are often accompanied by weight loss, especially progressive weight loss, which is one of the important manifestations of cancer cachexia). Therefore, the granules of the compositions of Examples 1, 2 and 3 of the present invention can provide comprehensive and balanced nutritional support for patients and can well promote the recovery of patients; moreover, the granules of the composition of Example 3 of the present invention have a more comprehensive and balanced effect in providing nutrition for patients.

[0178] As can be seen from Table 4, the improvement of the albumin level, serum albumin, body weight and CRP level of the patients taking the granules of Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 is not obvious. For example, the albumin level of the patients after taking still showed moderate protein malnutrition; the serum albumin level of the patients after taking was still lower than the normal value; the CRP level of the patients after taking still showed a mild increase; in addition, the body weight of the patients after taking did not increase. It can be seen that the granules of the compositions of Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 cannot provide comprehensive and balanced nutritional support for patients and cannot promote the recovery of patients.

[0179] To further prove the beneficial effects of the present invention, the present invention replaces serotonin, ethanolamine, and β-hydroxy-β-methylbutyric acid in the first nutrient component with other substances having similar properties, and replaces poria exosomes, carrot exosomes, ginger exosomes, oat exosomes, tomato exosomes, and donkey-hide gelatin exosomes in the second nutrient component with other substances having similar properties. The present invention replaces glucose, brown rice protein powder, fish oil microcapsule powder, xylo-oligosaccharide, niacinamide, riboflavin, and L-carnitine in the third nutrient component with other substances having similar properties. The results show that the clinical results are comparable to those of Comparative Example 1 after the prepared composition is taken for 2 cycles.

[0180] To further prove the beneficial effects of the present invention, the present invention replaces agastache rugosa, perilla leaf, dried tangerine peel, and evodia rutaecarpa in the first efficacy component with other substances having similar properties, and replaces Chinese yam, angelica sinensis, safflower, dwarf lilyturf tuber, and tremella fuciformis in the second efficacy component with other substances having similar properties. The present invention replaces medicated leaven, amomum villosum, heterophylly falsestarwort root, paris polyphylla, and tsaoko fruit in the third efficacy component with other substances having similar properties. The results show that the clinical results are comparable to those of Comparative Example 2 after the prepared composition is taken for 2 cycles.

[0181] To further prove the beneficial effects of the present invention, the present invention adjusts the weight ratios of the first nutrient component, the second nutrient component, and the third nutrient component outside the ratios of the present invention, adjusts the weight ratios of the first efficacy component, the second efficacy component, and the third efficacy component outside the ratios of the present invention, adjusts the weight portions of the components in the first nutrient component, the second nutrient component, and the third nutrient component outside the weight portions of the present invention, and adjusts the weight portions of the first efficacy component, the second efficacy component, and the third efficacy component outside the weight portions of the present invention. The results show that the clinical results are comparable to those of Comparative Example 2 after the prepared composition is taken for 2 cycles.

[0182] Through the effect verification experiments of Experiment 1 and Experiment 2, it can be known that the formula system of the composition provided by the present invention for relieving discomfort during gastrointestinal tumor treatment is a whole. Specifically, the functions of the various raw materials in the composition for relieving discomfort during gastrointestinal tumor treatment support each other and have an interaction relationship. It is precisely because the functions of the various raw materials support each other and have an interaction relationship that the composition provided by the present invention for relieving discomfort during gastrointestinal tumor treatment can effectively improve symptoms such as nausea, vomiting, fatigue, weakness, and malnutrition in patients after gastrointestinal tumor surgery, and can comprehensively supplement the nutrients required by patients and promote the recovery of patients.

[0183] In summary, the composition provided by the present invention contains a variety of specific nutritional components, specifically, a first nutritional component composed of serotonin, ethanolamine, β-hydroxy-β-methylbutyric acid, and acetoacetyl coenzyme A, a second nutritional component composed of Poria cocos exosomes, carrot exosomes, ginger exosomes, oat exosomes, tomato exosomes, and donkey-hide gelatin exosomes, and a third nutritional component composed of glucose, brown rice protein powder, fish oil microcapsule powder, xylo-oligosaccharide, niacinamide, riboflavin, and L-carnitine. These components act together in the patient's body to provide comprehensive and balanced nutritional support for the patient and promote the patient's recovery.

[0184] The composition provided by the present invention also contains a variety of specific efficacy components, specifically, a first efficacy component composed of Pinellia ternata, Agastache rugosa, Perilla frutescens, Citrus reticulata Blanco, and Evodia rutaecarpa, a second efficacy component composed of Dioscorea opposita, Angelica sinensis, Carthamus tinctorius, Ophiopogon japonicus, and Tremella fuciformis, and a third efficacy component composed of Medicated Leaven, Amomum villosum, Pseudostellaria heterophylla, Paris polyphylla, and Tsaoko fruit. According to the compatibility principle of traditional Chinese medicine theory, these components can specifically relieve symptoms such as nausea, vomiting, fatigue, weakness, and malnutrition in patients after gastrointestinal tumor surgery, and improve the quality of life of patients.

[0185] The composition of the present invention is prepared from efficacy components and nutritional components composed of natural medicinal materials, and is safe without side effects. At the same time, through reasonable formula design and preparation process, the cost is moderate and it is easy for patients to accept and use.

[0186] Through the synergistic effect of the nutritional components and efficacy components of the composition provided by the present invention, as well as the overall balance and regulation, these components interact with each other in the human body to jointly regulate the physiological functions of the patient. While providing comprehensive nutrition for the patient, it can effectively relieve symptoms such as nausea, vomiting, fatigue, weakness, and malnutrition in patients after gastrointestinal tumor surgery, and can also avoid side effects. The applicant speculates that on the one hand, it may be due to: First, the first nutritional component may help regulate neurotransmitters and energy metabolism, thereby reducing the patient's fatigue and weakness. At the same time, the second efficacy component can reduce fatigue and weakness caused by factors such as physical consumption, anemia, or psychological factors caused by treatment; the combination of the first nutritional component and the second efficacy component further reduces the fatigue and weakness caused by internal and external factors in the patient. Second, the second nutritional component has a unique bilayer membrane structure, rich bioactive substances, and a variety of bioactive functions. This bilayer membrane structure, bioactive substances, and bioactive functions help promote intestinal health, enhance immunity, and may have an anti-inflammatory effect, thereby reducing the side effects of tumor treatment on the gastrointestinal tract; the combination of the second nutritional component and the first efficacy component can effectively relieve nausea and vomiting caused by abnormal gastrointestinal motility. Third, the third nutritional component helps to overall regulate the nutritional status of the patient; at the same time, combined with the third efficacy component, it is more helpful to improve gastrointestinal function, promote digestion and absorption, and thus reduce the occurrence of malnutrition.

[0187] The composition of the present invention can be prepared into various dosage forms, such as tablets, granules, pills, powders, ointments, capsules, extracts or powders, etc., which is convenient for patients to choose a suitable dosage form according to their own conditions for use.

[0188] It should be understood that the present invention disclosed is not limited to the specific methods, schemes and substances described, as these can vary. It should also be understood that the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the scope of the present invention, the scope of which is only limited by the appended claims.

Claims

1. A composition for alleviating discomfort in the treatment of gastrointestinal tumors, characterized in that: The composition comprises nutritional ingredients and functional ingredients, wherein the nutritional ingredients comprise a first nutritional ingredient, a second nutritional ingredient and a third nutritional ingredient; wherein, The first nutrient component is composed of the following components: 5-hydroxytryptamine, ethanolamine, β-hydroxy-β-methylbutyric acid and acetoacetyl coenzyme A; The second nutrient component is composed of the following components: Poria cocos exosomes, carrot exosomes, ginger exosomes, oat exosomes, tomato exosomes and donkey-hide gelatin exosomes; The third nutrient component consists of the following components: glucose, brown rice protein powder, fish oil microcapsule powder, xylo-oligosaccharide, nicotinamide, riboflavin and L-carnitine.

2. The composition according to claim 1, characterized in that The functional ingredients include a first functional ingredient, a second functional ingredient and a third functional ingredient; wherein, The first effective ingredient is composed of the following components: pinellia tuber, patchouli, perilla leaf, tangerine peel and evodia rutaecarpa; The second effective ingredient is composed of the following components: Chinese yam, Chinese angelica, safflower, ophiopogon japonicus and white fungus; The third effective ingredient is composed of the following components: Shenqu, Amomum villosum, Pseudostellaria baicalensis, Paris polyphylla and Amomum villosum.

3. The composition according to claim 1, characterized in that The weight ratio of the first nutrient component, the second nutrient component and the third nutrient component is 0.3-0.8:0.5-1:

1.

4. The composition according to claim 2, characterized in that The weight ratio of the first functional ingredient, the second functional ingredient and the third functional ingredient is 1:1:

1.

5. The composition according to claim 1, characterized in that According to weight parts, The first nutrient component is composed of the following components: 0.5-2 parts of 5-hydroxytryptamine, 1-1.5 parts of ethanolamine, 0.5-1 parts of β-hydroxy-β-methylbutyric acid and 1-2 parts of acetoacetyl coenzyme A; The second nutrient component is composed of the following components: 0.3-0.5 parts of Poria cocos exosomes, 0.5-1 parts of carrot exosomes, 0.2-0.5 parts of ginger exosomes, 1-1.5 parts of oat exosomes, 1-2 parts of tomato exosomes and 0.5-1 parts of donkey-hide gelatin exosomes; The third nutrient component consists of the following components: 5-7 parts of glucose, 15-18 parts of brown rice protein powder, 15-17 parts of fish oil microcapsule powder, 5-7 parts of xylo-oligosaccharides, 0.5-1 parts of nicotinamide, 0.5-1 parts of riboflavin and 2-5 parts of L-carnitine.

6. The composition according to claim 2, characterized in that According to weight parts, The first effective ingredient is composed of the following components: 2-5 parts of pinellia tuber, 10-15 parts of patchouli, 5-8 parts of perilla leaf, 4-6 parts of dried tangerine peel and 10-12 parts of evodia rutaecarpa; The second effective ingredient is composed of the following components: 5-10 parts of Chinese yam, 5-7 parts of Chinese angelica, 8-10 parts of safflower, 3-6 parts of ophiopogon japonicus and 6-9 parts of Tremella fuciformis; The third effective ingredient is composed of the following components: 2-5 parts of Shenqu, 10-13 parts of Amomum villosum, 5-8 parts of Pseudostellaria heterophylla, 6-8 parts of Paris polyphylla and 3-7 parts of Amomum villosum.

7. The composition according to claim 1, characterized in that The weight ratio of the nutritional ingredients to the functional ingredients is 1:0.5-0.

8.

8. A pharmaceutical preparation, characterized in that The composition is made from the composition according to any one of claims 1 to 7 and pharmaceutically acceptable excipients.

9. The method for preparing the composition according to any one of claims 1 to 7, characterized in that: The preparation method comprises the following steps: Prepare the first nutrient component, the second nutrient component and the third nutrient component respectively, and mix them according to the proportion to obtain the nutrient component; Prepare a first functional ingredient, a second functional ingredient and a third functional ingredient respectively, and mix them according to a proportion to obtain the functional ingredient; The composition is obtained by mixing the nutritional ingredients and the functional ingredients according to a certain proportion.

10. Use of the composition according to any one of claims 1 to 7 in the preparation of any of the following preparations: 1) Preparations for preventing and treating postoperative recurrence and metastasis of gastrointestinal tumors; 2) Preparations for improving clinical symptoms of patients after gastrointestinal tumor surgery, wherein the clinical symptoms include one or more of nausea and vomiting, fatigue and weakness, and malnutrition; 3) Preparations that improve the quality of life of patients after gastrointestinal tumor surgery.

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