CN114949135A

CN114949135A - Traditional Chinese medicine composition for treating digestive tract reaction after chemotherapy and preparation method thereof

Info

Publication number: CN114949135A
Application number: CN202210706702.6A
Authority: CN
Inventors: 黄萍; 葛明华; 袁国荣; 张轶雯; 郑小卫; 潘宗富; 宋飞凤; 邹小舟; 杨秀丽
Original assignee: Zhejiang Provincial Peoples Hospital
Current assignee: Zhejiang Provincial Peoples Hospital
Priority date: 2022-06-21
Filing date: 2022-06-21
Publication date: 2022-08-30
Anticipated expiration: 2042-06-21
Also published as: CN114949135B

Abstract

The invention relates to a traditional Chinese medicine composition for treating digestive tract reaction after chemotherapy. The composition comprises 13 raw medicinal materials of tuckahoe, ginger processed pinellia tuber, coix seed, dried orange peel, round cardamom, bitter orange, oriental waterplantain rhizome, diverse wormwood herb, chicken's gizzard-membrane, hawthorn fruit, inula flower, ruddle and codonopsis pilosula, and has the effects of strengthening spleen, eliminating dampness, harmonizing stomach, promoting digestion, lowering adverse qi, stopping vomiting and the like. The Chinese medicinal composition has definite curative effect, quick response and no toxic or side effect on digestive system reactions after chemotherapy of malignant tumors, such as anorexia, nausea, vomiting, stomach discomfort, diarrhea, constipation and other spleen deficiency and damp stagnation and food stagnation, and provides a new choice for clinically treating digestive tract reactions after chemotherapy.

Description

Traditional Chinese medicine composition for treating digestive tract reaction after chemotherapy and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating digestive tract reaction after chemotherapy and a preparation method thereof.

Background

At present, the incidence rate of malignant tumors is higher and higher, and the malignant tumors become one of serious diseases threatening human health. The treatment modes comprise means such as surgery, chemotherapy, radiotherapy, targeting and the like, wherein chemotherapy is the most common treatment means, but has toxic and side effects. The most direct, most common and earliest toxic and side effects of chemotherapeutic drugs on patients are adverse reactions such as anorexia, nausea, vomiting, weight loss and the like, the fear of the patients on treatment is increased, and serious patients have to stop antitumor treatment. Research shows that 70-80% of chemotherapy patients can have symptoms of nausea and vomiting without intervention for preventing adverse reactions of the digestive tract, and serious patients can cause water and electrolyte imbalance, malnutrition and the like, so that the chemotherapy patients are important influencing factors with poor treatment compliance of the patients. Particularly, the incidence rate of nausea, vomiting and other digestive tract reactions caused by cisplatin is higher than 90 percent, and the survival quality and the treatment effect of patients are seriously influenced. Therefore, how to effectively prevent and treat the chemotherapy digestive tract reaction becomes an important research direction for clinical medicine and scientific researchers.

The mechanisms of chemotherapy-induced emesis are currently thought to be primarily peripheral and central. The peripheral mechanism is mainly that chemotherapy drugs destroy gastrointestinal mucosa, and enterochromaffin cells release neurotransmitters such as 5-hydroxytryptamine, substance P, dopamine and the like, so that vagus nerves and visceral nerve afferent fibers on the intestinal wall receive stimulation, and then signals are transmitted to the vomiting center of the brainstem to cause vomiting; the central mechanism is that chemotherapeutic medicine indirectly passes through emetic chemosensory areas and transmits signals to emetic centers to trigger emesis. Therefore, 5-HT3A receptor antagonists, glucocorticoids, NK1 receptor antagonists, dopamine receptor blockers and the like are often used clinically to treat chemotherapeutic gastrointestinal reactions.

The 5-HT3A receptor antagonist comprises ondansetron, granisetron, palonosetron, ramosetron, azasetron, etc.; the glucocorticoid drug is dexamethasone; NK-1 receptor antagonist drugs include aprepitant, fosaprepitant, etc., and dopamine receptor blockers include meglumine chloride (metoclopramide ); in addition, the mental drugs such as haloperidol, olanzapine, lorazepam, alprazolam and the like. However, the above drugs have various degrees of side effects, such as: after the 5-HT3A receptor antagonist is used by a patient, symptoms such as fatigue, severe constipation and headache can appear, or angina pectoris, electrocardiogram change and the like can appear; after the NK-1 receptor antagonist is used, adverse reactions such as anorexia, fatigue, constipation, diarrhea, weakness and the like often occur; while a large amount of DA receptor blockers results in mild lethargy, diarrhea and reversible extrapyramidal reactions. Often, patients with severe digestive tract reactions mostly adopt combination of several medicines for antiemetic effect, but most patients do not eat food at the appetite, so that the weight is reduced, and the subsequent treatment is not facilitated.

The traditional Chinese medicine has good effect on treating digestive tract reaction after chemotherapy, has no adverse side effect, and is easily accepted by patients. The malignant tumor is taken as a chronic disease, chemotherapy is generally required to be carried out for a plurality of times, in order to consolidate the chemotherapy effect and reduce the side effect of taking an antiemetic, a Chinese patent medicine which has quick response, strong antiemetic effect, appetite improvement and small toxic and side effect needs to be found, and the digestive tract reaction related to the tumor treatment is actively and reasonably prevented and treated, thereby providing guarantee for the smooth tumor treatment.

Disclosure of Invention

In order to overcome the defects that most of the existing medicines for treating digestive tract reaction after chemotherapy are chemical medicines, a plurality of medicines are required to be combined, side effects with different degrees exist, the appetite cannot be improved even though vomiting is treated, and the index does not address the root cause, the invention aims to provide the traditional Chinese medicine composition which has high safety, quick response and strong antiemetic effect, can improve the appetite, has no obvious toxic or side effect, and provides treatment guarantee for long-term chemotherapy of patients.

In order to realize the technical purpose of the invention, the invention provides a traditional Chinese medicine composition for treating digestive tract reaction after chemotherapy, which is prepared from the following traditional Chinese medicinal materials: poria cocos, ginger processed pinellia tuber, semen coicis, dried orange peel, round cardamom, fructus aurantii, rhizoma alismatis, artemisia anomala, endothelium corneum gigeriae galli, hawthorn, inula flower, ruddle and codonopsis pilosula.

Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:

further preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:

in a preferred embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:

preferably, the coix seed is fried coix seed.

Preferably, the hawthorn is fried hawthorn.

Preferably, the codonopsis pilosula is fried codonopsis pilosula.

The digestive tract reaction of malignant tumor patients is one of the most common complications in the chemotherapy process, the incidence rate is high, the reaction is serious, and even some patients abandon the chemotherapy because of intolerance. The traditional Chinese medicine considers that the digestive system reaction after tumor chemotherapy belongs to the categories of 'stomach fullness', 'vomiting' and the like, the malignant tumor patients have internal pathogen and toxin, the weak body caused by long-term illness and weakness of spleen and stomach, and the poor transportation and transformation of the spleen and stomach lead to food stagnation, the body fluid is stopped and accumulated as dampness, and the dampness is accumulated as phlegm. The main clinical manifestations are anorexia, nausea and vomiting, stomach discomfort, diarrhea, constipation, etc., and the severe cases may have anorexia, water electrolyte disorder, malnutrition, emaciation, anemia, etc.

The formula has the effects of invigorating spleen, eliminating dampness, harmonizing stomach, promoting digestion, lowering adverse qi and preventing vomiting, and can effectively treat digestive system reaction diseases after tumor chemotherapy. In the formula, fried codonopsis pilosula, poria cocos and semen coicis are monarch drugs for tonifying qi, invigorating spleen and eliminating dampness. Pinellia ternate and dried orange peel have the effects of drying dampness and reducing phlegm, regulating qi and regulating the middle warmer; rhizoma alismatis and artemisia anomala have the effects of inducing diuresis to alleviate edema, clearing heat and removing blood stasis; endothelium corneum Gigeriae Galli has effects of invigorating stomach, resolving food stagnation, arresting seminal emission, relieving stranguria, and removing calculus; the fried hawthorn has the functions of promoting digestion and strengthening the stomach, promoting qi circulation and removing blood stasis, eliminating turbid pathogen and reducing blood fat, and is good at eliminating meat food stagnation; the three groups of medicines aim at three aspects of phlegm, dampness and accumulation, lead phlegm-dampness to be dissolved and accumulation to be eliminated, assist monarch medicines to strengthen the spleen and stomach, and are used as ministerial medicines together. Inulae flos and Haematitum are used as adjuvant drugs for descending qi and eliminating phlegm, checking adverse rise of qi and relieving vomiting. Fructus Aurantii, with the actions of regulating qi, relieving epigastric distention, activating stagnancy and relieving distension, and Dou kou, fructus Amomi rotundus, resolving dampness, activating qi-flowing, warming middle energizer and arresting vomiting, are used as guiding drugs together. The whole formula is applied in combination of tonifying and digestion, and is particularly suitable for patients with spleen and stomach weakness caused by tumor chemotherapy and phlegm dampness and food stagnation.

The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition, the traditional Chinese medicine raw materials are extracted and purified to prepare a traditional Chinese medicine extract, the traditional Chinese medicine extract is taken as a raw material, acceptable auxiliary materials are added, and various dosage forms are prepared according to the conventional technology of pharmaceutics. The traditional Chinese medicine extract is obtained by respectively extracting traditional Chinese medicine raw materials, jointly extracting traditional Chinese medicine raw materials or other methods, such as: pulverizing, sieving, percolating, extracting with water, extracting with ethanol, and micronizing. The Chinese medicinal extracts can be in the form of extractum, dry extractum or fluid extractum, and can be prepared into different extractum forms according to different requirements of preparations.

The preferred processing mode is as follows: decocting the raw material medicines in water for 1-4 times, each time for 1-4h, adding 4-12 times of water each time, filtering the extract, mixing, concentrating, centrifuging or adding ethanol for alcohol precipitation, filtering, adding pharmaceutically acceptable adjuvants into the filtrate to prepare into liquid preparation or drying into extract dry powder, and adding pharmaceutically acceptable adjuvants to prepare into clinically acceptable dosage forms.

The preferred preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) selecting Poria, ginger processed pinellia Tuber, Coicis semen, pericarpium Citri Tangerinae, fructus Amomi rotundus, fructus Aurantii, Alismatis rhizoma, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi, Inulae flos, Haematitum, and radix Codonopsis, cleaning, and removing impurities; wherein Coicis semen is parched with bran to slight yellow; parching fructus crataegi to brown surface and brown inside; parching radix Codonopsis with rice until the surface turns dark yellow, taking out, sieving to remove rice, and cooling;

(2) adding 4-12 times of water into the medicinal materials in the step (1) and decocting for 2-4 h; discharging the decoction, adding water, decocting for 1-2 hr for 1-3 times, mixing decoctions, and concentrating to obtain extract;

(3) and (3) taking the extract obtained in the step (2), centrifuging or adding ethanol for alcohol precipitation, filtering, adding pharmaceutically acceptable auxiliary materials, and preparing into clinically acceptable dosage forms by a conventional process.

Preferably, in the step (2), the poria cocos, the ginger processed pinellia tuber, the fried coix seed, the dried orange peel, the bitter orange, the rhizoma alismatis, the artemisia anomala, the endothelium corneum gigeriae galli, the fried hawthorn, the inula flower, the ruddle and the fried rice processed codonopsis pilosula are added with 4-12 times of water and decocted for 1-2h, the cardamom is added for continuously decocting for 1-2h, the decoction liquid is discharged, the water is added for decocting for 1-3 times, each time lasts for 1-2h, the decoction liquids are combined and concentrated to obtain the extract.

Preferably, in the step (2), the poria cocos, the ginger processed pinellia tuber, the fried coix seed, the dried orange peel, the bitter orange, the rhizoma alismatis, the artemisia anomala, the endothelium corneum gigeriae galli, the fried hawthorn, the inula flower, the ruddle and the fried rice processed codonopsis pilosula are added with 6-10 times of water and decocted for 1-2 hours, the cardamom is added for continuous decoction for 1-2 hours, the decoction liquid is discharged, the water is added for decoction for 1-2 times, the decoction liquid is combined, and the concentrated extract is obtained.

Preferably, the decoction in the step (2) is combined and concentrated into the extract with the relative density of 1.05-1.30 at 50-60 ℃.

Preferably, ethanol is added into the extract in the step (3) when necessary until the alcohol content reaches 60-80%, the mixture is subjected to ethanol precipitation for 24-48h and then filtered, and the filtrate is subjected to reduced pressure concentration to recover the ethanol.

Preferably, the pharmaceutically acceptable auxiliary materials are one or more of filling agents, diluents, flavoring agents, lubricants, preservatives, adhesives, disintegrating agents and preservatives.

Further preferably, the pharmaceutically acceptable excipients include, but are not limited to, lactose, starch, dextrin, powdered sugar, magnesium stearate, maltose, citric acid, tartaric acid, sodium hydroxide, aspartame, stevioside, sodium cyclamate, aspartame, potassium acesulfame, aspartame, sucralose, and the like.

Preferably, the clinically acceptable dosage form is granules, tablets, pills, capsules, oral liquid or mixture. In one embodiment, the dosage form is a granule, prepared by the method comprising:

(2) decocting Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 4-12 times of water for 0.5-3 hr, adding fructus Amomi rotundus, and decocting for 1-2 hr; discharging the decoction, adding water, decocting for 1-3 times, mixing decoctions, and concentrating to obtain extract with relative density of 1.10-1.30 at 50-60 deg.C;

(3) drying the extract obtained in the step (2) under normal pressure or reduced pressure to obtain dry extract, adding auxiliary materials, uniformly mixing, granulating by a dry method or a wet method, grading, and drying to obtain granules.

Preferably, in the step (2), the poria cocos, the ginger processed pinellia tuber, the fried coix seed, the dried orange peel, the bitter orange, the rhizoma alismatis, the artemisia anomala, the endothelium corneum gigeriae galli, the fried hawthorn, the inula flower and the ruddle are taken, 6-10 times of water is added into the raw material medicinal materials of the fried rice processed codonopsis pilosula, the mixture is decocted for 1-2 hours, the round cardamom is added, the decoction is continuously decocted for 1-2 hours, the decoction liquid is discharged, the mixture is decocted for 1-2 times by adding water, the decoction liquid is combined, and the mixture is concentrated to an extract with the relative density of 1.10-1.30 when the temperature is 50-60 ℃.

Preferably, the vacuum degree in the decompression drying process is-0.08 to 0.10Mpa, and the drying temperature is 65 to 75 ℃.

In one embodiment, the dosage form is an oral liquid or a mixture, and is prepared by the following method:

(2) decocting Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 4-12 times of water for 1-3 hr, adding fructus Amomi rotundus, and decocting for 1-2 hr; discharging the decoction, adding water, decocting for 1-3 times, mixing decoctions, and concentrating to obtain extract with relative density of 1.05-1.15 at 50-60 deg.C;

(3) centrifuging the extract obtained in the step (2), and filtering; or adding ethanol until the alcohol content reaches 60-80%, cold precipitating for 24-48 hr, filtering to obtain filtrate with qualified clarity, adding appropriate amount of correctant and/or antiseptic, adjusting pH, adding water to the total amount, stirring, filtering, bottling, and sterilizing to obtain oral liquid or mixture.

Preferably, in the step (2), the poria cocos, the ginger processed pinellia tuber, the fried coix seed, the dried orange peel, the bitter orange, the rhizoma alismatis, the artemisia anomala, the endothelium corneum gigeriae galli, the fried hawthorn, the inula flower and the ruddle are taken, 6-10 times of water is added into the raw material medicinal materials of the fried codonopsis pilosula, the mixture is decocted for 1-2 hours, the round cardamom is added, the decoction is continuously decocted for 1-2 hours, the decoction liquid is discharged, the mixture is decocted for 1-2 times by adding water, the decoction liquid is combined, and the mixture is concentrated to an extract with the relative density of 1.05-1.15 at the temperature of 50-60 ℃.

Detailed Description

The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.

Example 1 granules

(2) decocting 12 kinds of medicinal materials such as Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 8 times of water for 1 hr, adding fructus Amomi rotundus, and decocting for 2 hr; discharging the decoction, adding 6 times of water, decocting for 2 times (each time for 1 hr), mixing decoctions, and concentrating to obtain extract with relative density of 1.25(50-60 deg.C);

(3) vacuum drying the extract obtained in step (2) at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 65 deg.C to obtain dry extract, pulverizing the dry extract into fine powder, sieving, adding appropriate amount of sucrose powder, hydroxypropyl starch and mannitol, mixing, spraying appropriate amount of 90% ethanol, wet granulating, drying, and grading to obtain granule.

EXAMPLE 2 tablets

(2) decocting 12 kinds of medicinal materials including Poria, rhizoma Pinelliae preparata, semen Coicis, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis with 6 times of water for 0.5 hr, adding fructus Amomi rotundus, and decocting for 1.5 hr; discharging the decoction, adding 4 times of water, decocting for 2 times (each time for 1 hr), mixing decoctions, and concentrating to obtain extract with relative density of 1.15(50-60 deg.C);

(3) centrifuging the extract obtained in step (2), filtering, collecting filtrate, concentrating the filtrate under reduced pressure to obtain a relative density of 1.21(50-60 deg.C), vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 75 deg.C to obtain a dry extract, pulverizing into fine powder, sieving, adding appropriate amount of starch, dextrin and sucrose, mixing, making into coarse granule, drying, pulverizing, sieving, granulating, drying, grading, adding 0.2% magnesium stearate, mixing, and tabletting.

Example 3 granules

(2) decocting 12 kinds of medicinal materials including Poria, rhizoma Pinelliae preparata, semen Coicis, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 10 times of water for 2 hr, adding fructus Amomi rotundus, and decocting for 1 hr; discharging the decoction, adding 6 times of water, decocting for 3 times (each time for 1.5 hr), mixing decoctions, and concentrating to obtain extract with relative density of 1.23(50-60 deg.C);

(3) vacuum drying the extract obtained in step (2) at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 65 deg.C to obtain dry extract, pulverizing the dry extract into fine powder, sieving, adding appropriate amount of sucrose powder and hydroxypropyl starch, mixing, dry granulating, and grading to obtain granule.

EXAMPLE 4 pellets

(2) decocting 12 kinds of medicinal materials including Poria, rhizoma Pinelliae preparata, semen Coicis, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 8 times of water for 0.5 hr, adding fructus Amomi rotundus, and decocting for 1 hr; discharging the decoction, adding 6 times of water, decocting for 3 times (each time for 1 hr), mixing decoctions, and concentrating to obtain extract with relative density of 1.30(50-60 deg.C);

(3) vacuum drying the extract obtained in step (2) at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 65 deg.C to obtain dry extract, pulverizing the dry extract into fine powder, sieving, adding dextrin, mixing, making into pill, and drying to obtain pill.

EXAMPLE 5 capsules

(2) decocting 12 kinds of medicinal materials including Poria, rhizoma Pinelliae preparata, semen Coicis, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 4 times of water for 3 hr, adding fructus Amomi rotundus, and decocting for 1.5 hr; discharging the decoction, adding 4 times of water, decocting for 3 times (each time for 1 hr), mixing decoctions, and concentrating to obtain extract with relative density of 1.18(50-60 deg.C);

(3) adding ethanol into the extract obtained in the step (2) to enable the alcohol content to reach 60%, performing cold precipitation for 48h, filtering, recovering ethanol from filtrate, concentrating to obtain extract with the relative density of 1.22(50-60 ℃), drying the extract at 75 ℃ under normal pressure to obtain dry extract, crushing into fine powder, sieving, adding a proper amount of starch and microcrystalline cellulose, uniformly mixing, granulating, drying, finishing granules, filling into a capsule shell, polishing in a polishing machine, and removing damaged capsules to obtain capsules.

Example 6 mixture

(1) Selecting the medicinal materials of tuckahoe, ginger processed pinellia tuber, coix seed, dried orange peel, round cardamom fruit, bitter orange, oriental waterplantain rhizome, diverse wormwood herb, chicken's gizzard-membrane, hawthorn fruit, inula flower, ruddle, pilose asiabell root and the like according to the prescription amount, cleaning and removing impurities for later use; wherein Coicis semen is parched with bran to slight yellow; parching fructus crataegi to brown surface and brown inside; parching radix Codonopsis with rice until the surface turns dark yellow, taking out, sieving to remove rice, and cooling;

(2) decocting 12 kinds of medicinal materials such as Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 8 times of water for 1 hr, adding fructus Amomi rotundus, and decocting for 2 hr; discharging the decoction, adding 6 times of water, decocting for 2 times, each time for 1 hr, mixing decoctions, and concentrating to obtain extract with relative density of 1.14(50-60 deg.C);

(3) adding ethanol into the extract obtained in the step (2) to make the alcohol content reach 70%, performing cold precipitation for 48h, filtering to obtain an ethanol precipitation solution, recovering ethanol, concentrating to a solution for preparation with a relative density of 1.08(50-60 ℃), adjusting pH to 7.0, adding water to the total preparation amount, stirring, filtering, filling and sealing, and sterilizing to obtain the mixture.

Example 7 oral liquid

(2) decocting 12 kinds of medicinal materials such as Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 12 times of water for 2 hr, adding fructus Amomi rotundus, and decocting for 1 hr; discharging the decoction, adding 10 times of water, decocting for 3 hr, mixing decoctions, and concentrating to obtain extract with relative density of 1.05(50-60 deg.C);

(3) adding ethanol into the extract obtained in the step (2) to enable the alcohol content to reach 80%, carrying out cold precipitation for 24h, filtering to obtain an ethanol precipitation solution, recovering ethanol, filtering until the clarity is qualified to obtain a preparation solution, adding a proper amount of aspartame, adjusting the pH to 7.0, adding water to the total preparation amount, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid.

Example 8 mixture

(2) decocting 12 kinds of medicinal materials such as Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 9 times of water for 2 hr, adding fructus Amomi rotundus, and decocting for 2 hr; discharging the decoction, adding 8 times of water, decocting for 2 times, each time for 1 hr, mixing decoctions, and concentrating to obtain extract with relative density of 1.10 deg.C (50-60 deg.C);

(3) adding ethanol into the extract obtained in the step (2) to enable the alcohol content to reach 70%, carrying out cold precipitation for 36h, filtering to obtain an ethanol precipitation solution, recovering the ethanol, concentrating to a solution for preparation with the relative density of 1.09(50-60 ℃), adding a proper amount of sucralose, adjusting the pH to 7.0, adding water to the total preparation amount, stirring, filtering, filling and sealing, and sterilizing to obtain the mixture.

EXAMPLE 9 pellets

(2) decocting 12 kinds of medicinal materials including Poria, rhizoma Pinelliae preparata, semen Coicis, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 10 times of water for 1 hr, adding fructus Amomi rotundus, and decocting for 2 hr; discharging the decoction, adding 8 times of water, decocting for 2 times (each time for 2 hr), mixing decoctions, and concentrating to obtain extract with relative density of 1.26(50-60 deg.C);

(3) vacuum drying the extract obtained in step (2) at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 65 deg.C to obtain dry extract, pulverizing the dry extract into fine powder, sieving, adding appropriate amount of water, mixing to obtain soft material, making into pill, drying, selecting pill, and packaging to obtain pill.

EXAMPLE 10 oral liquid

(1) Selecting Poria, ginger processed pinellia Tuber, Coicis semen, pericarpium Citri Tangerinae, fructus Amomi rotundus, fructus Aurantii, Alismatis rhizoma, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi, Inulae flos, Haematitum, and radix Codonopsis, cleaning, and removing impurities; wherein Coicis semen is parched with bran to slight yellow; parching fructus crataegi to brown surface and brown inside; parching radix Codonopsis with rice to dark yellow, taking out, sieving to remove rice, and cooling;

(2) decocting 12 kinds of medicinal materials such as Poria, rhizoma Pinelliae preparata, semen Coicis preparata, pericarpium Citri Reticulatae, fructus Aurantii, rhizoma Alismatis, herba Artemisiae Anomalae, endothelium corneum Gigeriae Galli, fructus crataegi preparata, flos Inulae, Haematitum, and radix Codonopsis preparata with 8 times of water for 1 hr, adding fructus Amomi rotundus, and decocting for 1 hr; discharging the decoction, adding 6 times of water, decocting for 1 hr, mixing decoctions, and concentrating to obtain extract with relative density of 1.09(50-60 deg.C);

(3) adding ethanol into the extract obtained in the step (2) to enable the alcohol content to reach 70%, carrying out cold precipitation for 48h, filtering to obtain an ethanol precipitation solution, recovering ethanol, filtering until the clarity is qualified to obtain a preparation solution, adding a proper amount of sucrose powder, adjusting the pH to 7.0, adding water to the total preparation amount, stirring, filtering, encapsulating, and sterilizing to obtain the oral liquid.

Comparative example 1 granules

(1) Taking 14 medicinal materials according to the prescription amount, adding water for decocting for 2 times, adding 8 times of water for decocting for 3 hours for the first time, adding 6 times of water for decocting for 2 hours for the second time, combining the decoction, and concentrating to obtain an extract with the relative density of 1.26(50-60 ℃).

(2) Vacuum drying the extract obtained in step (1) at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 65 deg.C to obtain dry extract, pulverizing the dry extract into fine powder, sieving, adding appropriate amount of sucrose powder, hydroxypropyl starch and mannitol, mixing, spraying appropriate amount of 90% ethanol, wet granulating, drying, and grading to obtain granule.

In order to verify the curative effect of the Chinese medicinal composition, the inventor carries out a large number of pharmacodynamic and clinical experimental studies, and the following experimental examples are used for explaining that the medicament selected in the pharmacodynamic experiment of the medicament is the medicament obtained by the representative formula and the preparation method thereof, and the experiments and results related to the medicaments obtained by other formulas and the preparation method thereof are not exhaustive due to space limitation.

Experimental example 1 Effect of the composition of the present invention on rats injected with cisplatin

1.1 Experimental materials

Experimental animals: 80 male SPF-level rats with weight of 200 +/-20 g are provided by people hospital in Zhejiang province, and have license number SYXK (Zhe) 2019-. Raising temperature: 25 +/-2 ℃, relative humidity of 60% +/-10% and 12h as periodic fluorescent lamp illumination, and the food and the water can be taken freely. Rat feed and padding were purchased from dencapone laboratory animal breeding limited.

Experimental reagent: cisplatin for injection, lyophilized form, specification: 20 mg/bottle, manufactured by Qilu pharmaceutical Co., Ltd; aprepitant capsule, specification: (1)125mg, (2)80 mg; manufactured by zilu pharmaceutical limited. 0.9% sodium chloride injection, specification: 500 ml; 4.5 g/bottle, manufactured by Shandong Colon pharmaceutical Co. Kaolin, chemically pure CP, specification: 500 g/bag, Shanghai-sourced leaf Biotech, Inc. Gum arabic powder, specification: 500 g/bottle, Shanghai-derived leaf Biotech Co., Ltd. The composition of the invention: granules prepared in example 1; comparative composition: granules prepared in comparative example 1.

1.2 protocol

Experimental animals are fed in a single cage, are adaptively fed for 1 week, and are randomly divided into 8 groups, a blank control group, a model control group and a positive control group, wherein the composition of the invention is low, medium and high, the test group of the invention and the comparison composition are low and high, each group comprises 10 animals, the experimental animals are fed in the single cage, and kaolin is added into a rat cage during the adaptive feeding period, and common feed is simultaneously fed to adapt the existence of the kaolin. Observing whether the surface of the kaolin has the bite marks or not, weighing the consumption of the kaolin at regular time, and starting the experiment when the rats do not bite any more.

3ml of physiological saline is respectively administered to the blank control group and the model control group for each time for intragastric administration, the other groups are administered with the treatment medicine for pretreatment, 11.25mg/kg is administered on the 1 st day of the positive control group, 7.2mg/kg is administered on the 2 nd to 3 rd days, 3ml of physiological saline is administered on the 4 th to 5 th days, and the content is calculated by aprepitant; the granules prepared in example 1 are respectively administrated by low, medium and high dose groups in the test, and are respectively 7.56g of crude drug/kg.d, 15.12g of crude drug/kg.d and 30.24g of crude drug/kg.d; the low and high dose components of the comparative composition are respectively dosed with 11.34g crude drug/kd.d and 22.68 g crude drug/kd.d; the gavage is carried out once a day for 3 days continuously.

Animal molding: 1h after the first administration, animals of a model control group, a positive control group, a test low-dose group, a test medium-dose group and a test high-dose group and a control composition low-dose group and a test high-dose group are molded by adopting a single intraperitoneal injection method of 6mg/kg cis-platinum, and a blank group is injected with the same amount of physiological saline.

General conditions of the rats were observed, including mental, activity, fur, appetite, respiration, stool, etc. The amount of kaolin and feed intake, body mass and water intake of the rats were weighed and recorded regularly until the end of the test. All data were statistically analyzed using SPSS20.0 software, expressed as mean. + -. standard deviation, and statistically processed using One-way ANOVA analysis, with p < 0.05 being statistically significant.

1.3 Effect of the compositions of the invention on chemotherapeutic rats

1.3.1 Effect of the compositions of the invention on the general conditions of chemotherapeutic rats

Before modeling, rats in each group are active and move, the mental state is good, the reaction is quick, the fur is glossy and regular, and the diet defecation is normal. After the model is made, the blank group is not abnormal, the hair of the rat is bright, active and mobile, the rat can actively seek food, the weight is obviously increased, the excrement is dark brown particles, the texture is hard, and the breath is stable; the rats in the model control group and the control composition low-dose group have the phenomena of lusterless fur, laziness in movement, poor appetite, emaciation, irritability, cage biting and the like; the low-dose group and the high-dose group of the composition have reduced activities, no appetite, slightly emaciation and cage biting phenomenon; the positive control group rats and the middle and high dose group rats have the symptoms of occasional reduced activity, slow response and the like, but the overall condition is good, and is greatly improved compared with the model group. The feces of rats fed with kaolin are grey white, and all the rats have loose stools.

1.3.2 Effect of the compositions of the invention on Kaolin intake in chemotherapy rats

The experimental results are shown in table 1, and it can be seen from table 1 that the kaolin intake of the rats in each group before molding has no obvious difference and no statistical significance (P > 0.05). After modeling, compared with a blank group, the model group has the advantages that the food intake of the kaolin of the rat is obviously increased, and the statistical significance is obvious (P is less than 0.01), which indicates that the modeling of the rat with the chemotherapy vomiting is successful. In the acute vomiting stage after the administration, the positive control group, the experimental low, medium and high dose groups have obvious reduction of the food intake of the kaolin compared with the kaolin of the rats in the model group, and have obvious statistical significance (P is less than 0.01). The low, medium and high dose groups of the composition have no significant difference (P is more than 0.05) compared with the positive control group.

Table 1 effect of the composition of the invention on the amount of kaolin consumed in rats treated with chemotherapy (n-10,

)

note: "+" indicates P < 0.05, "+" indicates P < 0.01, compared to the blank control group;

compared with a model control group " ^▲ "means P < 0.05" ^▲▲ "means P < 0.01.

1.3.3 Effect of the compositions of the invention on feed intake in rats undergoing chemotherapy

The test results are shown in table 2, and it can be seen from table 2 that the differences of the feed intake of the rats in each group before molding are not obvious and have no statistical significance (P is more than 0.05). In the vomiting stage after model building, the feed intake of the rats in the model group is obviously reduced, and the statistical significance is achieved compared with that in the blank group (P is less than 0.01). Compared with the model group, each treatment group has an ascending trend, the positive control group and the experimental low, medium and high dose groups can obviously increase the food intake of the chemotherapy rats, and the statistical significance is realized (P is less than 0.01). The composition of the invention has no significant difference (P > 0.05) between the high dose group and the positive control group.

Table 2 effect of the composition of the invention on feed intake in chemotherapy rats (n-10,

)

note: "+" indicates P < 0.05, "+" indicates P < 0.01, compared to the blank control group; compared with the model control group,

“ ^▲ "denotes P < 0.05" ^▲▲ "means P < 0.01.

1.3.4 Effect of the compositions of the invention on Water intake in rats undergoing chemotherapy

The test results are shown in Table 3, and it can be seen from Table 3 that the difference of the water intake of the rats in each group before the model building is not obvious and has no statistical significance (P is more than 0.05). In the vomiting stage after model building, the drinking water of the rats in the model group is obviously reduced, and compared with the blank group, the model group has statistical significance (P is less than 0.01). Compared with the model group, the water intake of the chemotherapy rats in each treatment group is increased, and the water intake of the chemotherapy rats in the positive control group and the high dose group in the test can be obviously increased, so that the statistical significance is achieved (P is less than 0.01). The composition of the invention has no significant difference (P > 0.05) between the high dose group and the positive control group.

TABLE 3 Drinking water for rat in chemotherapy containing the composition of the present inventionThe effect of the quantity (n-10,

)

compared with a model control group " ^▲ "denotes P < 0.05" ^▲▲ "means P < 0.01.

1.3.5 Effect of the compositions of the present invention on the body weight of chemotherapeutic rats

The results are shown in Table 4, and it can be seen from Table 4 that the body weight of the rats in each group before molding is not significantly different and has no statistical significance (P > 0.05). In the vomiting stage after model building, the weight of the rats in the model group is obviously reduced, and the statistical significance is achieved compared with that in the blank group (P is less than 0.01). Compared with the model group, each treatment group has an ascending trend, the positive control group can obviously increase the weight of the chemotherapy rat in the middle and high dose groups, and the statistical significance is realized (P is less than 0.01). The composition of the invention has no significant difference (P > 0.05) between the high dose group and the positive control group.

Table 4 effect of the composition of the invention on the body weight of the rats treated with chemotherapy (n-10,

)

compared with a model control group " ^▲ "denotes P <" >0.05，“ ^▲▲ "means P < 0.01.

Experimental example 2 study of the composition of the present invention on a model of ferret emesis

2.1 materials of the experiment

Experimental animals: 30 healthy adult male brown ferrets are purchased from Wuxi coral reef biotechnology limited, SCXK (Su) 2017-.

Experimental reagent: cisplatin for injection, freeze-dried type, specification: 20 mg/bottle, manufactured by Qilu pharmaceutical Co., Ltd; ondansetron hydrochloride injection, specification: 2 ml: 4mg, manufactured by Qilu pharmaceutical Co., Ltd; 0.9% sodium chloride injection, specification: 500 ml; 4.5 g/bottle, manufactured by Shandong Colon pharmaceutical Co., Ltd; the composition of the invention: granules prepared according to example 1.

2.2 protocol

The experimental animals are fed in a single cage for 12h in a light and shade period, and are randomly divided into 5 groups of 6 animals, wherein each group is respectively a model control group, a positive control group, a test low, medium and high dose group. The model control groups are all given with 5.0ml/kg of physiological saline, and the positive control group is given with 2mg/kg of ondansetron hydrochloride; tests show that the composition of the invention is respectively administered with 3.28g of crude drug/kg, 6.55g of crude drug/kg and 13.10g of crude drug/kg in low, medium and high dosage components. 1h after administration, animals of a model control group, a positive control group and experimental low, medium and high dose groups are modeled by adopting a method of single intraperitoneal injection of 7.5mg/kg cis-platinum, vomiting reaction of the ferrets in 6h after intraperitoneal injection is observed, and vomiting latency, retching and vomiting times are recorded.

The test is observed by taking the vomiting latency, the retching and the vomiting times as treatment, and the vomiting process of the ferret model which is successfully modeled is divided into three processes: before vomiting, vomiting and after vomiting. The pre-vomiting ferrets are accompanied by nausea and movement before vomiting, such as drooling, jolting and retropulsion. When in vomiting, the mind moves forward and downward, the mouth is opened, the shoulder is shrunken, the abdomen is contracted, and the sound of vomiting sometimes occurs, and the person can recover to be in front of the vomiting after vomiting; the number of episodes from the onset of emesis to the onset of sedation was 1, and the latency of emesis was the time elapsed from the administration of cisplatin to the onset of emesis. Vomiting occurs when stomach contents are not vomited, and vomiting occurs when stomach contents are spitted. The anti-emetic effect of each group was compared. All data were processed using SPSS20.0 software, expressed as mean. + -. standard deviation, and statistically processed using One-way ANOVA analysis, with p < 0.05 being statistically significant.

2.3 study of the composition of the invention on antiemetic effect of the chemo-treated ferret model

The test results are shown in table 5, and it can be seen from table 5 that 6 ferrets in the model group all showed vomiting after the intraperitoneal injection of cisplatin, the vomiting latency period was very short, and the retching and vomiting times were significantly high. Compared with a model control group, the positive control group and the middle and high dose groups can obviously prolong the vomiting latency, the retching times and the vomiting times (P is less than 0.01) of cisplatin-induced vomiting ferrets. In the composition, the high-dose group has no significant difference (P is more than 0.05) compared with the positive control group.

Table 5 study of the present composition on antiemetic behavior in ferret model (n-6,

)

note: compared with a model control group " ^▲ "denotes P < 0.05" ^▲▲ "means P < 0.01.

Experimental example 3 clinical observations of digestive tract reactions after treatment with chemotherapy

3.1 general data

60 middle and late stage cancer patients who are diagnosed in 2018 and 2020 in Zhejiang province and people's hospital are selected, and are diagnosed by a clinician as spleen and stomach weakness, phlegm dampness and food stagnation caused by tumor chemotherapy. 36 male and 24 female; age 32-75 years, with clinicians randomized into trial and control groups, with 30 trial groups of 18 men, 12 women, and age 32-73 years; including 9 cases of lung cancer, 5 cases of breast cancer, 6 cases of gastric cancer, 4 cases of lymph cancer and 6 cases of rectal cancer; a control group of 30 cases, wherein 18 cases are male, 12 cases are female, and the age is 35-75 years; including 9 cases of lung cancer, 5 cases of breast cancer, 5 cases of gastric cancer, 4 cases of lymph cancer, and 7 cases of rectal cancer. The test group and the control group have no nausea and vomiting caused by brain metastasis, digestive tract obstruction and the like.

3.2 Experimental methods

The test group took the granules prepared in example 1 (168g crude drug) once a day for 5 consecutive days on the day of the conventional chemotherapy; the control group was administered with granisetron 100ml and metoclopramide 10mg + 0.9% sodium chloride 100ml once daily for 5 consecutive days starting on the day after the conventional chemotherapy.

3.3 evaluation of therapeutic Effect

The effect is shown: within 5 days of administration, no nausea and vomiting symptoms exist, and the stomach-receiving rate is obviously improved;

the method has the following advantages: within 5 days of administration, the symptoms of nausea and vomiting are not reduced to a certain extent, and the stomach reception is improved to a certain extent;

and (4) invalidation: within 5 days of administration, symptoms of nausea and vomiting are not relieved, the appetite is poor, and the food intake is small.

Effective rate (effective + effective)/total number of cases x 100%

3.4 results of the experiment

TABLE 6 clinical observation comparison of the therapeutic effects of two groups of patients

Note: compared to the model control, "-" indicates P < 0.05.

As can be seen from the experimental results in Table 6, the composition of the invention can obviously improve the digestive tract reaction after chemotherapy, the effective rate is as high as 86.7%, the total effective rate of the test group is obviously higher than that of the control group, and the comparative difference between the groups has statistical significance (P is less than 0.05).

Claims

1. A traditional Chinese medicine composition for treating digestive tract reaction after chemotherapy comprises the following traditional Chinese medicine components: poria cocos, ginger processed pinellia tuber, semen coicis, dried orange peel, round cardamom, fructus aurantii, rhizoma alismatis, artemisia anomala, endothelium corneum gigeriae galli, hawthorn, inula flower, ruddle and codonopsis pilosula.

2. The traditional Chinese medicine composition for treating post-chemotherapy digestive tract reactions according to claim 1, characterized by comprising the following components in parts by weight:

3. the traditional Chinese medicine composition for treating post-chemotherapy digestive tract reactions according to claim 1, characterized by comprising the following components in parts by weight:

4. the traditional Chinese medicine composition for treating post-chemotherapy digestive tract reactions according to claim 1, characterized by comprising the following components in parts by weight:

5. the composition according to claim 1, wherein the Coix seed is parched Coix seed; the hawthorn is fried hawthorn; the radix Codonopsis is parched radix Codonopsis.

6. The method for preparing a Chinese medicinal composition for treating post-chemotherapy digestive tract reactions according to any one of claims 1-5, characterized by decocting the raw material herbs in water for 2-4 times, 1-4h each time, adding 4-12 times of water each time, filtering the extractive solutions, mixing, concentrating, centrifuging or precipitating with ethanol, filtering, adding pharmaceutically acceptable adjuvants into the filtrate to make into liquid preparation or drying into dry extract powder, and adding pharmaceutically acceptable adjuvants to make into clinically acceptable dosage forms.

7. The method of claim 6, wherein the method comprises the steps of:

(3) and (3) taking the extract in the step (2), centrifuging or adding ethanol for alcohol precipitation, filtering, adding pharmaceutically acceptable auxiliary materials, and preparing into clinically acceptable dosage forms by a conventional process.

8. The method for preparing a Chinese medicinal composition for treating digestive tract reactions after chemotherapy as claimed in claim 7, wherein in step (2), Poria cocos, pinellia ternate, fried semen coicis, dried orange peel, fructus aurantii, rhizoma alismatis, herba artemisiae anomalae, endothelium corneum gigeriae galli, fried hawthorn, inula flower, ruddle and fried rice dangshen are taken, 6-10 times of water is added for decocting for 1-2h, round cardamom is added for continuing to decoct for 1-2h, the decoction is discharged, water is added for decocting for 1-2 times, each time is 1-2h, the decoctions are combined and concentrated to obtain an extract.

9. The method for preparing a Chinese medicinal composition for treating digestive tract reactions after chemotherapy according to claim 7, wherein the decoction in step (2) is combined and concentrated to an extract with a relative density of 1.05-1.30 at 50-60 ℃.

10. The method for preparing a Chinese medicinal composition for treating digestive tract reactions after chemotherapy according to claim 6, wherein the clinically acceptable dosage form is granules, tablets, pills, capsules, mixtures or oral liquids.