CN110559310B

CN110559310B - Composition with constipation preventing and treating effects and preparation method and application thereof

Info

Publication number: CN110559310B
Application number: CN201910783412.XA
Authority: CN
Inventors: 郭伟
Original assignee: Jilin Maifu Nutrition Technology Co ltd; Maifu Nutrition Technology Beijing Co Ltd
Current assignee: Jilin Maifu Nutrition Technology Co ltd; Maifu Nutrition Technology Beijing Co Ltd
Priority date: 2019-08-09
Filing date: 2019-08-23
Publication date: 2020-10-23
Anticipated expiration: 2039-08-23
Also published as: CN110559310A

Abstract

The invention relates to a composition with an effect of preventing and treating constipation, a preparation method and application thereof, wherein the composition comprises effective components of a first polymer and a second polymer, the first polymer and the second polymer are obtained by polymerizing monosaccharide and/or uronic acid of the monosaccharide through glycosidic bonds, the polymerization degree of the first polymer is an integer of 2-100, the polymerization degree of the second polymer is an integer of 10-3000, and the polymerization degree of the first polymer: the mass ratio of the second polymer is 1:3-1: 6. The composition is suitable for treating tumor-related diarrhea, has a bidirectional regulating effect on constipation and diarrhea, and can be taken for a long time.

Description

Composition with constipation preventing and treating effects and preparation method and application thereof

Technical Field

The invention relates to the field of biological medicine, in particular to a composition with a constipation prevention and treatment effect, and a preparation method and application thereof.

Background

Constipation is a common disease of the digestive system. The normal people defecate 1-2 times daily or 1 time every 1-2 days. Patients with constipation mostly show the symptoms of hard stools, difficult defecation, hard defecation, incomplete defecation, hard stools with small amount, reduced defecation frequency (less than or equal to 3 times per week) and the like. Survey shows that people of any age and any occupation can suffer from constipation, and the incidence rate of the constipation reaches 20-30% (Wangjiyao. science [ M ] 2 nd edition. Beijing: people's health publishing agency, 2011: 479.).

Constipation is one of the common complications of cancer patients. About 40% of patients with advanced tumors develop constipation, and 50% of patients with end-of-care suffer constipation within 4-12 days of hospitalization. The incidence rate of constipation during chemotherapy of tumor patients reaches up to 71.6% (investigation study of digestive tract symptoms of tumor chemotherapy patients [ J ]. Haimai, Zhujinci, Penna, nursing study, 2011, 25(2): 300). The incidence of constipation in patients with tumors is significantly higher than in patients with other diseases, and comprises the following aspects:

1. factors of the tumor itself

The primary tumor of the abdominal cavity and the pelvic cavity or the metastatic tumor can cause intestinal obstruction, so that the intestinal contents are obstructed, so that the feces reaching the rectum are few, and the defecation reflex cannot be triggered to cause constipation; or constipation caused by intestinal tract compression by tumor outside intestinal tract. When the tumor invades the lumbar vertebra to cause spinal cord injury or when the tumor invades the nerve to cause nerve injury, the motor muscles of defecation are damaged to different degrees to cause defecation power weakening, and simultaneously the conduction nerve is damaged, while the defecation intention impulse can not be transmitted to the brain to generate defecation reflex, so that the defecation is retained to cause constipation (wooley M, Bisanz A, Lyons HF, et al.

2. Iatrogenic factors

(1) Cytotoxic drug

Cytotoxic drugs such as vinca alkaloids (e.g., vincristine, vinblastine, vindesine, etc.), especially vincristine, have significant toxicity to autonomic nerves that govern intestinal motility, and can cause constipation due to gastric emptying and intestinal motility disorders (PeixotoJA, Teles BC, Castro EF, et al. Among patients receiving vincristine chemotherapy, about 50% of patients develop constipation to varying degrees, and even paralytic ileus in patients with severe constipation (Legha SS. Vincristeneurotoxicity. Pathophysiology and management [ J ]. Med Toxicol, 1986, 1(6): 421-). 427). Chemotherapeutic drugs that may cause constipation also include oxaliplatin (Cassidy J, Misset JL. Oxaliplatin-related side effects: char ACTs and management [ J ] Semin Oncol, 2002, 29(5Suppl 15):11-20), fluorouracil class drugs (tweeves C. Xeloda in Adjuvant Colon Cancer therapy (X ACT) tertiary: overview of efficacy, safety, and cost-effective less [ J ] Clin molecular Cancer, 2006, 6(4):278 and 287), and the like.

(2) Antiemetic/analgesic/antipsychotic drugs

Antiemetic drugs that cause constipation mainly include 5-HT3 receptor antagonists and NK-1 receptor antagonists. The 5-HT3 receptor and NK-1 receptor are widely present in the intramuscular plexus of the gastrointestinal tract and are associated with gastrointestinal motility and glandular secretion. These two antagonists, while blocking the receptor to relieve emesis, also inhibit constipation caused by gastrointestinal motility (Bosnjak SM, Neskovic-Konstantinovic ZB, Raulovic SS, et al. high efficiency of a single organism of the stomach tron 8mg of both of them are present in the preservation of the organism induced by the organism, and also in the preservation of the organism induced by the stomach, and also in the stomach and intestine cancer cell [ J ] cholesterol for the culture cancer [ J ] of the human intestine]J Chemother, 2000, 12(5): 446-. The opioid analgesic drug is combined with the opioid receptors in the intestinal tract, so that the intestinal tract peristalsis is slowed, and the glandular secretion is reduced; reducing excitability of the internus musculus plexus of the gastrointestinal tract, inhibiting neuron activity, and reducing sensitivity of the patient to defecation reflex stimulation; increase smooth muscle tension in the intestinal wall to inhibit peristalsis and increase non-peristaltic contractions (Ahmedzai SH, Boland J. stimulation in polyple descriptors J]Clin event (Online), 2010, 2010). Antidepressants, anticonvulsants, benzodiazepines

The like, can block 5-hydroxytryptamine and cholinergic receptors of the internus musculus plexus of the gastrointestinal tract, and inhibit constipation caused by gastrointestinal motility (Tamayo AC, Diaz-Zuuaga PA. management of opioid induced bone dysfunction excipients [ J)].Support Care Cancer，2004，12(9):613-618)。

3. Dietary factors

Chemotherapy drugs cause gastrointestinal dysfunction in patients undergoing chemotherapy and lead to decreased food and water intake in patients undergoing chemotherapy, coupled with the increased selection of digestible, low fiber diet, in patients undergoing chemotherapy to further reduce intestinal motility and cause constipation (Thomas J, Karver S, Cooney GA, et al. Methylnaltrex one for opioid-induced compliance in advanced insulin [ J ]. N Engl J Med,2008,358(22): 2332. sup. 2343).

4. Psychologic factors

Patients with tumor chemotherapy often suffer from anxiety and nervous emotion, which causes mental constipation. Anxiety can increase the tone of pelvic floor muscle groups, causing anorectal paradoxical movements during defecation, leading to constipation (West AF, Steinhardtt K. contact and inhibition in the human agency of inhibition [ J ]. Arch Dis Child, 2003, 88(12): 1038-.

5. Other factors

Nausea and vomiting of tumor chemotherapy patients are caused by chemotherapy drugs, so that dehydration, electrolyte disorder (such as hypokalemia, hypercalcemia and the like) and other adverse symptoms of the tumor chemotherapy patients occur, and intestinal tract motility dysfunction of the patients can be caused. In addition, chemotherapy causes hyperglycemia and adverse symptoms such as hypothyroidism in tumor patients, and aggravates constipation of patients. Constipation can also be caused by reduced activity and reduced food intake due to long-term bed rest after tumor resection.

The adverse effects of the constipation symptoms caused by tumor patients and tumor patients in radiotherapy, chemotherapy and operation on the tumor patients cannot be ignored. The tumor-related constipation comprises constipation caused by tumor, constipation related to tumor radiotherapy, constipation related to tumor chemotherapy, constipation related to tumor resection operation, constipation caused by any combination of radiotherapy, chemotherapy and resection operation of tumor patients, and the like, so that the tumor patients have symptoms of abdominal distension, abdominal pain, dysphoria, anorexia, anxiety, and the like. Patients with severe constipation can also have anal fissure, which directly affects the life quality of tumor patients and is not beneficial to the continuous progress of anti-tumor treatment. The leukemia patient is easy to cause infection after chemotherapy, if anal fissure occurs, infection can occur around the anus, serious patients can also cause bacteremia or septicemia, and even serious consequences such as shock and death can be caused.

Constipation is also often caused or accompanied by a variety of other causes. The method specifically comprises the following steps: (1) the patients have unsmooth defecation due to the dependence constipation caused by the laxatives and the stool softener, and the defecation is promoted by repeatedly using the laxatives and the stool softener, so that the autonomous movement of intestinal tracts is weakened, the enteric nervous system is damaged, and the constipation occurs; (2) the medicine is used for treating constipation. Anticholinergic drugs, opioids, calcium-containing or aluminum-containing preparations, antidepressants, nerve blocking agents and other drugs cause intestinal muscle relaxation to cause constipation; (3) senile constipation and constipation caused by long-term bed rest. The elderly or patients lying in bed for a long time cause constipation due to reduced activity and slow intestinal peristalsis; (4) constipation with reduced dietary or fluid intake. The dietary fiber content of the intake of the patient is low, the food intake or the water intake is reduced, and the stimulation of the colon movement is reduced to cause constipation; (5) constipation caused by change of eating habits. The change of the eating habits of the patients can cause the disorder of the normal physiological functions of the human body, influence the gastrointestinal functions and even aggravate constipation; (6) irritable bowel syndrome constipation type. Irritable bowel syndrome is a common clinical intestinal dysfunction, and the main symptoms of the irritable bowel syndrome are difficult defecation, dry and hard defecation, small quantity of the constipation and more mucus, the constipation can be interrupted or alternatively circulated with diarrhea, and the frequent accompanied defecation is endless; (7) chronic constipation. Chronic constipation is constipation which occurs repeatedly over a long period (more than 3 months), and the onset of the constipation can be caused by acute constipation which is not cured for a long time or chronic diseases (national treasury of external treatment of traditional Chinese medicine, Zhou De Sheng, Shuozhi Red eds., Hunan science and technology Press, 1 st edition of 10 months 2015, page 217).

Compared with constipation caused by other reasons, the constipation related to tumor has the characteristics of complex induction factors, complex and changeable adverse symptoms, multiple factors needing to be considered in intervention treatment, high treatment difficulty and the like, and is a difficult point in treating the constipation.

The harm caused by constipation is not negligible. Firstly, toxic substances cannot be discharged and can be reabsorbed by liver and kidney due to constipation, so that the metabolic burden of the liver and kidney is increased, and the liver and kidney function is damaged due to the long-term incurability; secondly, harmful toxins in the intestines continuously stimulate intestinal mucosa, toxic metabolites or carcinogens in the intestines and the body of the stomach cannot be removed for a long time, and gastrointestinal tract cancers such as stomach cancer, duodenum, colorectal cancer, colon cancer, cecum cancer and the like are easily induced; thirdly, accumulation of toxic substances can cause gastrointestinal nerve dysfunction, which causes poor symptoms such as anorexia, abdominal fullness, eructation, bitter taste in mouth, halitosis and the like, and influences the treatment of the original disease of the patient; fourthly, the long-term defecation force is easy to cause anorectal diseases, such as hemorrhoids, anal fissure, rectal prolapse, colonic diverticulum and the like; fifthly, the abdominal pressure and the intracranial pressure are increased rapidly due to the violent defecation force, and further angina, myocardial infarction attack, cerebral hemorrhage, sudden death and the like are induced; sixthly, metabolites in the body of a constipation patient are stagnated in the digestive tract for a long time, and harmful substances (such as methane, phenol, ammonia and the like) are partially diffused and enter the central nervous system to interfere and even damage brain functions, so that adverse symptoms such as memory decline, distraction, thought retardation, headache frequency, insomnia, irritability and the like are caused; seventh, constipation patients abused anthraquinone cathartics for a long time, which are liable to cause melanosis of colon and may involve rectum, sigmoid colon or even whole colon (Haoshaohoshaohisan, edited by Zhang Shi Suo, Kingdun publisher, 1 st edition of 09 month 2015, pages 38-41).

Dietary fiber has been studied to treat constipation. The dietary fiber is edible plant component, carbohydrate and its derivative which can not be digested and absorbed by human small intestine and can be partially or completely fermented in human large intestine, and its composition includes polysaccharide, oligosaccharide, lignin and related plant substances. Dietary fiber is classified into two major classes, water-Soluble Dietary Fiber (SDF) and Insoluble Dietary Fiber (IDF), according to its solubility characteristics. The water-Soluble Dietary Fiber (SDF) is dietary fiber which is not digested by digestive tract enzymes of human body, but can be dissolved in warm water and hot water and can be reprecipitated by ethanol, mainly comprises storage substances and secretion in plant cells, and comprises pectin, gum, glucan, arabic gum, carrageenan, guar gum, carrageenan, xanthan gum, agar, galactomannan, glucose, alginate, carboxymethyl cellulose and the like.

Non-digestible oligosaccharides (including inulin, lactulose, fructo-oligosaccharides, galacto-oligosaccharides, oligomannose, etc.) are non-digestible dietary compounds that are degraded by microorganisms of the intestinal microbiota. It has been shown that non-digestible oligosaccharides selectively stimulate the growth of bifidobacteria and/or other beneficial bacteria in the gastrointestinal tract, while the growth stimulation of beneficial bacteria can lower colonic pH, increase the production of short chain fatty acids, prevent the proliferation and adhesion of pathogenic microorganisms (barrier effect), increase the metabolism of potential carcinogens such as nitrosamines, and promote the production of vitamin B, and are used to prevent and treat constipation by improving stool characteristics and mucosal probiotics.

At present, the compositions with the function of preventing and treating constipation on the market have the following defects: (1) inulin causes a higher incidence of abdominal distension in the user; (2) galacto-oligosaccharides, stachyose, manno-oligosaccharides and the like can only play a role in regulating the balance of intestinal flora, and the abdominal distension has high incidence; (3) lactulose is converted into low molecular weight organic acid in colon by digestive tract flora, which causes the pH value in intestinal tract to be reduced, increases the gas production frequency of patients, and is easy to have adverse reactions such as flatulence, abdominal discomfort and the like after being taken.

Royal jelly and the like disclose a method for jointly improving constipation by utilizing a plurality of dietary fibers such as polydextrose, fruit and vegetable powder, inulin, fructo-oligosaccharide, sorbitol sugar, xanthan gum and the like ("the effect of improving constipation by a plurality of dietary fibers", royal jelly and the like, armed police medicine, 1 month 2014). The product has the following defects: firstly, the product uses inulin and fructo-oligosaccharide, polydextrose, xanthan gum and other components in combination, the product components are complex, the dietary fiber proportion suitable for different constipation crowds is not screened in a targeted manner, and the preparation cost is high; secondly, inulin is a linear straight-chain polysaccharide formed by connecting fructose through beta (2-1) bonds, the tail end of the inulin is often provided with glucose, and the polymerization degree is usually 2-60. Human experiments have shown that inulin promotes the growth of bifidobacteria in vivo, but has no inhibitory effect on the growth of harmful bacteria, has limited beneficial effects in improving intestinal flora disturbance, and can not be used by infants (0-3 years old) (A human volunteer study on the biological effects of HP-insulin-faecal bacteria using fluorescence in situ hybridization, Anaerobe, 2001), thereby limiting the applicable population of the product.

CN101176483A discloses a dairy product for improving intestinal health, which contains not less than 0.4% of fructo-oligosaccharide and not less than 1.0% of polydextrose. The product has two major defects: firstly, the milk powder needs to be used with milk products (such as milk, lactic acid beverage, formula milk powder, cheese and the like) at the same time, and patients with organic constipation mostly show high abdominal distension incidence caused by intolerance of the milk products; secondly, the content of dietary fiber in the product is low, which is not beneficial to improving gastrointestinal peristalsis, and the constipation improving effect is limited.

Currently, commercially available constipation treating drugs or compositions have the following drawbacks: (1) the traditional Chinese medicine composition is limited in adaptation diseases, more in contraindications, limited in applicable population and application mode, and particularly not suitable for patients with tumor-related constipation; (2) is not easy to be absorbed, has obvious side effect and can not be taken for a long time; (3) the dietary fiber content is insufficient, the clinical requirement of enhancing the gastrointestinal peristalsis of patients is difficult to meet, and the repeated constipation symptom is easy to appear; (4) the product does not effectively improve the composition of intestinal flora and balance flora structure, and cannot fundamentally solve the problem of constipation; (5) lactulose contained in the product is converted into low molecular weight organic acid by digestive tract flora in colon, so that the pH value in intestinal tract is reduced, the gas generation times of a patient are increased, and adverse reactions such as flatulence, abdominal discomfort and the like are caused to a user; (6) the product has poor clarity, influences the appearance, flavor and taste, and influences the administration compliance of patients. Therefore, the development of a composition having an effect of preventing and treating constipation, particularly a composition for preventing and treating tumor-related constipation, which satisfies clinical needs, is a very urgent clinical need.

Disclosure of Invention

The invention aims to provide a composition with an effect of preventing and treating constipation, wherein effective components in the composition are a first polymer and a second polymer, the first polymer and the second polymer are obtained by polymerizing monosaccharide and/or uronic acid of the monosaccharide through glycosidic bonds, the polymerization degree of the first polymer is an integer from 2 to 100, the polymerization degree of the second polymer is an integer from 10 to 3000, and the ratio of the first polymer: the mass ratio of the second polymer is 1:3-1: 6.

In a preferred technical scheme of the invention, the monosaccharide is selected from any one or combination of fructose, sorbose, glucose, rhamnose, xylose, galactose, arabinose, fucose, gulose, mannose, xylose and lyxose.

In a preferred embodiment of the present invention, the degree of polymerization of the first polymer is an integer of 2 to 80, preferably an integer of 2 to 50, and more preferably an integer of 2 to 20.

In a preferred embodiment of the present invention, the first polymer is selected from any one of fructo-oligosaccharide, galacto-oligosaccharide, hemicellulose, lactosucrose and xylo-oligosaccharide or a combination thereof, and preferably the first polymer is selected from any one of fructo-oligosaccharide, galacto-oligosaccharide and xylo-oligosaccharide or a combination thereof.

In a preferred embodiment of the present invention, the polymerization degree of the second polymer is an integer of 20 to 2000, preferably an integer of 20 to 1000, and more preferably an integer of 20 to 500.

In a preferred embodiment of the present invention, the second polymer is selected from any one of gums, polydextrose, gum arabic, carrageenan, guar gum, carrageenan, xanthan gum, agar, galactomannan, alginate, and carboxymethyl cellulose, or a combination thereof, and preferably the second polymer is polydextrose.

In a preferred embodiment of the present invention, the ratio of the first polymer: the mass ratio of the second polymer is 1:4-1: 5.

The compositions of the present invention may be in various dosage forms well known in the art and may be prepared using formulation techniques conventional in the art. The preparation suitable for the present invention is an oral preparation, preferably, the oral preparation is selected from any one of oral liquid (liquid preparation), syrup, suspension, tablet, capsule, granule, pill, powder, dripping pill, mixture, distillate, effervescent, paste, emulsion and tea, more preferably, any one of oral liquid (liquid preparation), syrup, suspension, granule, powder, tablet, capsule and effervescent.

The pharmaceutically acceptable carrier of the present invention includes common excipients or adjuvants well known in the art for preparing the above formulations, including but not limited to fillers (also called diluents), lubricants (also called glidants or antiadherents), dispersants, wetting agents, binders, regulators, solubilizers (also called stabilizers), antioxidants, bacteriostats (also called preservatives), emulsifiers, flavors or fragrances, and the like. A binder, such as syrup, acacia, gelatin, sorbitol, tragacanth, cellulose and derivatives thereof, gelatin slurry, syrup, starch and starch derivatives, starch slurry or polyvinylpyrrolidone, preferably the cellulose derivative is selected from any one or a combination of microcrystalline cellulose, sodium carboxymethylcellulose, ethylcellulose, hydroxypropylmethylcellulose, more preferably the starch derivative is selected from any one or a combination of sodium carboxymethylcellulose, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropylstarch, maize starch; fillers, such as lactose, powdered sugar, dextrin, starch or derivatives thereof, cellulose or derivatives thereof, inorganic calcium salts, any one or a combination of sorbitol or glycine, preferably the inorganic calcium salts are selected from any one or a combination of calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate, more preferably the cellulose derivatives are selected from any one or a combination of microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, preferably the starch derivatives are selected from any one or a combination of sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch; lubricants, such as any one or a combination of aerosil, magnesium stearate, talc, aluminum hydroxide, boric acid, hydrogenated vegetable oil, polyethylene glycol; a disintegrant, such as any one of starch or its derivatives, polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, microcrystalline cellulose or a combination thereof, preferably the starch derivative is selected from any one of sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch or a combination thereof; wetting agents such as sodium lauryl sulfate, water or alcohols, and the like; emulsifiers such as polysorbate-80, sorbitan elatate, pluronic F-68, lecithin, soy lecithin, etc.

In a preferable technical scheme of the invention, a pharmaceutically acceptable carrier is further added into the composition, and the pharmaceutically acceptable carrier is selected from any one or combination of an acid-base regulator, a preservative, a stabilizer, an antioxidant, a flavoring agent or an aromatizing agent.

In a preferred embodiment of the present invention, the acid-base regulator is selected from any one of inorganic acids and organic acids or a combination thereof, preferably selected from any one of citric acid, sodium citrate, malic acid, sodium malate, acetic acid, sodium acetate, phosphoric acid, sodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid, sodium carbonate, sulfonic acid, sodium sulfonate, glutamic acid, tartaric acid, sodium tartrate, lactic acid, sodium lactate, fumaric acid, sodium fumarate, itaconic acid, ascorbic acid, sodium ascorbate, nicotinic acid, sodium nicotinate, fumaric acid, α -ketoglutaric acid, tartaric acid, sodium malate, acetic acid, oxalic acid, succinic acid, carbon dioxide, citric acid, and sodium citrate or a combination thereof, and more preferably any one of citric acid, acetic acid, malic acid, and citric acid or a combination thereof.

In a preferable technical scheme of the invention, the concentration of the pH regulator is 0.5-8mol/L, preferably 0.8-6mol/L, more preferably 1-5mol/L, and most preferably 2-4 mol/L.

In the preferable technical scheme of the invention, the pH value of the composition is less than or equal to 4.6.

In a preferred embodiment of the present invention, the stabilizer (solubilizer) is selected from any one of glycerol, tween-80, or a combination thereof.

In a preferred embodiment of the present invention, the preservative is selected from any one of 0.5% phenol, 0.3% cresol, 0.5% chlorobutanol, or a combination thereof.

In a preferred technical scheme of the invention, the antioxidant is selected from any one of potassium sorbate, sodium sulfite, sodium bisulfite, sodium metabisulfite and dibutylbenzoic acid or a combination thereof.

In a preferred technical scheme of the invention, the aromatizer is selected from any one of spice, edible spice and flavoring essence or the combination thereof.

In addition, the active ingredient and the pharmaceutically acceptable sustained-release carrier can be mixed according to the preparation requirements, and then prepared into pellets, such as sustained-release pellets or controlled-release pellets, according to the preparation method of the sustained-release preparation well known in the art, such as adding a retardant coating or microencapsulating the active ingredient; the sustained and controlled release carrier comprises but is not limited to an oil-fat doping agent, a hydrophilic colloid, a coating retarder and the like, wherein the oil-fat doping agent is selected from any one or the combination of glyceryl monostearate, hydrogenated castor oil, mineral oil, polysiloxane and dimethyl siloxane; the hydrophilic colloid is selected from any one or combination of sodium carboxymethylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, PVP, acacia, tragacanth and carbopol; the coating retarder is selected from any one of Ethyl Cellulose (EC), hydroxypropyl methyl cellulose (HMPC), polyvinylpyrrolidone (PVP), Cellulose Acetate Phthalate (CAP), acrylic resin or their combination.

Another object of the present invention is to provide a method for preparing the composition of the present invention, comprising the steps of preparing a first polymer and a second polymer as active ingredients, wherein the first polymer and the second polymer are obtained by polymerizing a monosaccharide and/or uronic acid of the monosaccharide through glycosidic bond, the degree of polymerization of the first polymer is an integer of 2 to 100, the degree of polymerization of the second polymer is an integer of 10 to 3000, and the first polymer: and the mass ratio of the second polymer is 1:3-1:6, weighing the required amount of the first polymer and the second polymer, and uniformly mixing to obtain the polymer.

In a preferable technical scheme of the invention, the composition is a liquid preparation, and is obtained by weighing the first polymer and the second polymer with required amounts, adding the water with required amounts, and stirring for dissolving.

The invention also aims to provide application of the composition in preparing a product for preventing and treating tumor-related constipation.

In a preferred embodiment of the present invention, the constipation associated with tumor is any one or a combination of constipation caused by tumor, constipation associated with tumor radiotherapy, constipation associated with tumor chemotherapy, constipation associated with tumor resection, and constipation caused by any combination of radiotherapy, chemotherapy and resection of tumor patients.

In a preferred embodiment of the present invention, the tumor is selected from any one of solid tumor and non-solid tumor or a combination thereof.

In a preferred technical scheme of the invention, the solid tumor is any one or combination of gastric cancer, colon cancer, rectal cancer, bladder cancer, kidney cancer, prostate cancer, breast cancer, lung cancer, brain tumor, bone cancer, pancreatic cancer, liver cancer and bile duct cancer.

In a preferred embodiment of the present invention, the non-solid tumor is selected from any one of lymphoma and leukemia, or a combination thereof.

Another object of the present invention is to provide the use of the composition of the present invention for the preparation of a product for preventing and treating functional constipation.

In a preferred embodiment of the present invention, the functional constipation is any one selected from the group consisting of senile constipation, constipation due to prolonged bed rest, drug-induced constipation, constipation due to drug dependence, constipation due to reduced fluid intake, constipation due to change of eating habits, and constipation due to irritable bowel syndrome, or a combination thereof.

In a preferred technical scheme of the invention, the senile constipation is constipation caused by insufficient defecation power due to slow intestinal peristalsis and weakened abdominal muscle contraction force of the elderly.

In a preferred embodiment of the present invention, the drug for treating sexual constipation is any one or a combination of a gastric disorder drug, an antidiarrheal drug, an antihypertensive drug, a calcium channel antagonist, a central nervous system drug, an anticholinergic drug, a diuretic drug, an antiallergic drug, an anesthetic, ephedrine, ibuprofen, a calcium supplement drug, and an iron supplement drug.

In a preferred technical scheme of the invention, the gastropathy drug is any one or the combination of aluminum hydroxide, sucralfate, bismuth potassium citrate and calcium carbonate.

In a preferred embodiment of the present invention, the antidiarrheal is selected from any one of loperamide and montmorillonite or a combination thereof.

In a preferred embodiment of the present invention, the antihypertensive agent is selected from any one of calcium channel antagonists and clonidine, or a combination thereof.

In a preferred technical scheme of the invention, the calcium ion channel antagonist is any one or the combination of nifedipine and verapamil.

In a preferred embodiment of the present invention, the central nervous system drug is selected from any one of antidepressants, antipsychotics, antiparkinsonian drugs, anticonvulsants, or a combination thereof.

In a preferred technical scheme of the invention, the anticholinergic is selected from any one or combination of atropine, procaine and belladonna mixture.

In a preferred embodiment of the present invention, the laxative in the laxative-dependent constipation is any one or a combination of a bulk laxative, an osmotic laxative, a stimulant laxative, a lubricating laxative (stool softener), an enema suppository, a microecological preparation, and a gastric motility promoting drug.

Another object of the present invention is to provide the use of the composition of the present invention for the preparation of a product for the prevention and treatment of organic constipation.

In a preferred embodiment of the present invention, the organic constipation is any one or a combination of constipation caused by rectal or anal disorders, constipation caused by colonic obstruction or spasm, constipation caused by compression of tumors in the abdominal or pelvic cavities, and constipation caused by intestinal muscle relaxation due to systemic diseases.

In a preferred technical scheme of the invention, the rectal or anal lesion is selected from any one of anal fissure, anal fistula, hemorrhoid and perianal abscess or a combination thereof.

In a preferred embodiment of the present invention, the colonic obstruction or spasm is selected from any one of colonic tumor, intestinal obstruction, intestinal adhesion, congenital megacolon, and crohn's disease, or a combination thereof.

In a preferred technical scheme of the invention, the tumor in the abdominal cavity or the pelvic cavity is any one or combination of hysteromyoma, cervical cancer and gastrointestinal cancer, preferably the gastrointestinal cancer is any one or combination of gastric cancer, duodenal cancer, colon cancer, rectal cancer, colorectal cancer, cecum cancer, colon cancer reduction and adenocarcinoma.

In a preferred embodiment of the present invention, the systemic disease is selected from any one of uremia, diabetes, hypothyroidism, or a combination thereof.

The invention also aims to provide the application of the composition in preparing products for treating acute constipation and chronic constipation.

In a preferred embodiment of the present invention, the chronic constipation is any one or a combination of outlet obstruction constipation, slow transit constipation, and a combination of outlet obstruction constipation and slow transit constipation.

Another object of the present invention is to provide the use of the composition of the present invention for preparing a product for preventing and treating alternate constipation and diarrhea.

In a preferred technical scheme of the invention, the constipation and diarrhea alternation is selected from diarrhea and constipation alternation caused or complicated by tumor constipation, diarrhea and constipation alternation caused or complicated by tumor-related constipation, diarrhea and constipation alternation caused or complicated by senile constipation, diarrhea and constipation alternation caused or complicated by long-term bed rest, diarrhea and constipation alternation caused or complicated by functional constipation, diarrhea and constipation alternation caused or complicated by medicines, any one or combination of alternating diarrhea and constipation caused or complicated by laxative dependence, alternating diarrhea and constipation caused or complicated by chronic constipation, alternating diarrhea and constipation caused or complicated by reduced fluid intake, alternating diarrhea and constipation caused or complicated by dietary habit change, alternating diarrhea and constipation caused or complicated by irritable bowel syndrome, and alternating diarrhea and constipation caused or complicated by colorectal cancer.

In a preferred embodiment of the present invention, the dosage of the composition of the present invention is related to the age, sex, health status, current treatment status, drug combination and the like of the patient, and the recommended dosage is 7.5-15 g/time and 2-3 times/day.

In a preferred embodiment of the present invention, when the composition of the present invention is used for preventing constipation, the user can take the composition of the present invention 1 to 3 days before taking a product which causes constipation symptoms, and the recommended dose is 7.5 to 15 g/time and 1 to 2 times/day.

Another object of the present invention is to provide a composition having constipation prevention and treatment effects, which is prepared by combining the composition of the present invention with any one of a fiber supplement, a laxative, a probiotic, or a combination thereof.

In a preferred technical scheme of the invention, the microecological preparation is selected from any one of probiotics and prebiotics or a combination thereof.

In order to clearly convey the scope of the invention, the invention is defined by the following terms:

1. the "degree of polymerization" as used herein refers to an index for measuring the molecular size of a polymer. Based on the number of repeating units, namely the average value of the number of the repeating units contained in the macromolecular chain of the polymer; based on the number of structural units, i.e., the number of individual structural units contained in the macromolecular chain of the polymer. Each polymer is composed of homologous polymer molecules with different polymerization degrees, and the polymerization degrees have statistical average significance. Generally, the degree of polymerization refers to the average degree of polymerization of the polymer.

2. Unless otherwise indicated, when the present invention relates to percentages between liquids, said percentages are volume/volume percentages; the invention relates to the percentage between liquid and solid, said percentage being volume/weight percentage; the invention relates to the percentages between solid and liquid, said percentages being weight/volume percentages; the balance being weight/weight percent.

3. The "B/E value" in the present invention is the ratio of the number of bifidobacteria to enterobacteria in vivo. The B/E value is used as an index for evaluating the intestinal microorganism colonization resistance, and the influence of the composition and the combination mode thereof on microorganisms such as bifidobacterium, enterobacter, enterococcus, saccharomycetes and the like of a constipation patient is qualitatively and quantitatively detected to verify the beneficial effect of the composition for preventing and treating constipation.

Intestinal microbial Colonization Resistance (CR) was proposed in 1971 by professor Van derwaaij of the Netherlands microbiologist and refers to the ability of intestinal endogenous obligate anaerobes to suppress the number of potentially pathogenic flora of the major aerobic species in the digestive tract. Research shows that the B/E value is less than 1, which indicates that the intestinal colonization resistance is damaged (Wu Zhongwen, etc., a new index of intestinal microbial colonization resistance, namely the B/E value, Zhejiang preventive medicine, 2000, 12: 4-5). The lower the B/E value is, the weaker the intestinal colonization resistance of the patient is, the lower the pathogenic bacteria invasion resistance is, and constipation is more easily caused.

The invention adopts a plate counting method to measure the quantity of bifidobacteria and the quantity of enterobacteria in the excrement of a patient, thereby calculating the quantity ratio (B/E value) of the bifidobacteria and the enterobacteria.

4. The 'tumor-related constipation' comprises constipation caused by tumors, constipation related to tumor radiotherapy, constipation related to tumor chemotherapy, constipation related to tumor resection operation, and constipation caused by any combination of radiotherapy, chemotherapy and resection operation of tumor patients.

5. The term "constipation associated with tumor chemotherapy" as used herein refers to pathological constipation occurring in a patient with tumor during or after chemotherapy. It is mainly manifested as constipation less than 3 times per week, accompanied by adverse symptoms such as constipation and dyschezia.

6. The term "chronic constipation" as used herein means a chronic, functional constipation. Chronic constipation is a type of disease that gradually produces difficulty in defecation at different ages due to changes in the anatomical structures of the innate or acquired colon and rectum. The essence of chronic constipation is chronic incomplete intestinal obstruction, and clinically, constipation is classified into colonic slow transit constipation, outlet obstruction constipation, and mixed constipation in which both are present.

Compared with the prior art, the beneficial technical effects of the invention comprise:

1. the first polymer selected by the invention has unique bidirectional regulation effect on intestinal flora, and can promote the growth and proliferation of bifidobacterium and/or other beneficial bacteria in the stomach and intestine and improve the intestinal flora structure; secondly, the volume of the excrement is increased through fermentation, the excretion is promoted, and the retention time of the excrement in the intestines of the patient is shortened; thirdly, short chain fatty acid generated in the body of a patient is increased, the pH value of the intestinal tract is reduced, excessive propagation and adhesion of pathogenic bacteria are inhibited, and the intestinal tract flora structure is improved; fourthly, the metabolism of potentially carcinogenic amine compounds or toxic substances is promoted, the generation of vitamin B is increased, and the capability of intestinal mucosa for resisting pathogenic bacteria and toxic substances is enhanced.

2. The second polymer selected according to the invention has the following advantages: the dietary fiber supplement composition can supplement the content of dietary fiber in a patient body, improve the peristalsis function of a gastrointestinal tract and enhance the protection effect of an intestinal mucosa; secondly, the water-insoluble dietary fiber is not contained, so that the incidence rate of adverse reactions such as abdominal distension, gas production and the like of the patient is effectively reduced; thirdly, colloidal substances are formed in the small intestine, and the intestinal toxic substances are adsorbed, so that the absorption of the toxic substances is reduced, the intestinal peristalsis is increased, the rapid discharge of the toxic substances is promoted, the retention time of the intestinal toxic substances in the intestine is shortened, the intestinal irritation is reduced, and the intestinal tumor is prevented; and fourthly, the functions of the gastrointestinal tract are improved, the protection effect of intestinal mucosa is enhanced, and the blood fat, the blood sugar level and the like of the human body are adjusted.

3. The composition of the invention screens the compositions and the mixture ratio of the first polymer and the second polymer, and fully exerts the effects and the synergistic interaction of the two components: on one hand, the intestinal flora is bidirectionally adjusted, the volume of the excrement is increased, the retention time of the excrement in the intestines is shortened, and the capability of the intestinal mucosa for resisting pathogenic bacteria and toxin is enhanced; on the other hand, the composition supplements dietary fiber, improves the wetting degree of excrement, promotes gastrointestinal motility, increases the adsorption and excretion of toxic substances, regulates the blood fat and blood sugar levels of human bodies, and the two components supplement each other with external communication, thereby comprehensively improving the constipation symptom, improving the gastrointestinal function and avoiding the vicious circle of converting constipation into diarrhea; thirdly, the composition of the invention obviously improves the gas generation times of patients, and patients do not have bad feelings of flatulence and abdominal discomfort after taking the composition; fourthly, the composition of the invention has good appearance and taste and good compliance for patients.

4. The composition has good effect of preventing and treating the constipation related to tumors, is suitable for preventing and treating the constipation caused by various reasons, and has the advantages of no stimulation to intestines and stomach, passing and slowly improving the intestinal function, no rapid change of blood sugar and blood pressure, flexible application mode, no use contraindication, long-term use and the like.

5. The composition of the invention is beneficial to discharging the toxin in the body of a patient, purifying the physique, and fundamentally solving the problems of metabolism disorder, endocrine dyscrasia, unbalanced trace elements and the like caused by constipation: firstly, the skin of a user is promoted to be smooth, fine, ruddy and elastic, and wrinkles, acnes and pigmented spots are reduced, so that the anti-aging and nourishing beauty are delayed; secondly, subcutaneous fat and oil of a user are discharged, the circulation metabolism of the body is improved, and the proud flesh of the waist and abdomen and the edema of the lower limbs are eliminated, so that the body is slim and shaped, and the body is light; thirdly, the immunity of the organism of the user is improved, the sub-health state is improved, and therefore the health care and health preservation effects are achieved, and the disease prevention and body building effects are achieved; fourthly, harmful substances (such as methane, phenol, ammonia and the like) are prevented from diffusing into the central nervous system, and the brain function is maintained, so that the mood is pleasant and the thinking is quick; fifthly, the traditional Chinese medicine preparation has the effects of helping digestion and relieving flatulence, improving the metabolism of the organism, keeping the breath of a user fresh, and obviously improving bad symptoms such as halitosis and body odor.

6. The composition does not contain live bacteria preparation, can be used together with other medicines, reduces the risk of bacterial cross infection, and has the advantages of flexible use mode, tube feeding or oral administration, no side effect, wide applicable population and the like.

7. The composition of the invention has simple preparation and obvious cost benefit, and is suitable for industrial mass production.

Detailed Description

The present invention is described below with reference to examples. The invention is not limited to the examples.

Example 1Composition and proportioning research of the composition

The compositions were prepared by weighing the required amounts of the first polymer and the second polymer as shown in Table 1, wherein the total amount of the first polymer and the second polymer was 40 parts, adding 60 parts of water, and dissolving by stirring.

130 patients with tumor chemotherapy-related constipation are selected, the nature is not limited, the age range of the tested patients is 40-60 years, no intestinal tract disease is required within 1 month, and antibiotics, microecological drinks or health care medicines are not taken.

130 patients were randomized into 13 groups of 10 patients each. Wherein 12 groups are experimental groups, and the composition A-L is administered to the patients respectively at a dosage of 15g each time for 2 times per day for 14 days; group 13 is a blank control group and the subject takes an equal amount of water during the trial period without any composition, number M.

During the experiment, the subject diets were normal. The B/E value of the tested patients is determined according to the method of the invention, and the abdominal distension incidence rate and the constipation recurrence rate of the patients are counted.

Taking 2.0g of each of the compositions A-L, taking 2.0g of purified water as a blank control group M, respectively adding 50mL of 50mmol/L lead nitrate solution, stirring at 37 deg.C, centrifuging for 4 hr, respectively, collecting supernatant, and measuring Pb²⁺The adsorption rate was determined from the difference between the concentrations before and after the reaction. The results are shown in Table 1.

TABLE 1 composition and compounding ratio of the compositions of the present invention

As can be seen from Table 1, the compositions A-L all improved intestinal colonization resistance. Compared with a blank control group, the tested patient taking the composition A-C, G-I has a higher B/E value, which indicates that the balance of microbial flora in the gastrointestinal tract can be better maintained, and the capability of resisting pathogenic bacteria of the patient is improved.

The compositions A-L can reduce the abdominal distension incidence and constipation recurrence rate of the tested patients. Compared with a blank control group, the compositions A-C, G-I and K can better relieve the abdominal distension and pain of a constipation patient and show better effect of preventing constipation recurrence.

Compositions A to L can each adsorb Pb²⁺Ions. Compositions A-C, G-K adsorbed Pb compared to the blank control²⁺The ion effect is better, and toxic and harmful substances (such as Pb) in intestinal tract can be effectively removed²⁺Ions, etc.).

Comprehensively considering the B/E value, the abdominal distention incidence rate, the constipation recurrence rate and the Pb adsorption of the composition²⁺And the ionic rate and the like result that the first polymer is fructo-oligosaccharide or galacto-oligosaccharide, and the second polymer is polydextrose, so that the constipation effect is comprehensively improved.

Example 2Raw material ratio research experiment of composition

The compositions were prepared by weighing the required amounts of the first polymer and the second polymer, 40 parts of the total parts of the first polymer and the second polymer, and adding 60 parts of water to the mixture, followed by stirring and dissolving.

100 patients with relevant constipation caused by tumor chemotherapy are selected, the nature is not limited, the age range of the patients is 40-60 years, the patients have no intestinal tract disease within 1 month, and antibiotics, microecological drinks or health care medicines are not taken.

100 patients were randomized into 10 groups of 10 patients each. Wherein 9 groups are test groups, and the composition is administered for 14 days at a dose of 15g each time for 2 times per day by 1-9 times; group 10 is a blank control group and the subject takes an equal amount of water during the trial period without any composition, numbered 10.

Taking 2.0g of each of the compositions 1-9, taking 2.0g of purified water as a blank control group 10, respectively adding 50mL of 50mmol/L lead nitrate solution, stirring at 37 deg.C, centrifuging for 4 hr, collecting supernatant, and measuring Pb²⁺The adsorption rate was determined from the difference between the concentrations before and after the reaction. The results are shown in Table 2.

TABLE 2 composition and compounding ratio research experiment of the composition of the present invention

As can be seen from Table 2, compositions 1-9 all improved intestinal colonization resistance. Compared with a blank control group, the tested patients taking the compositions 3-9 have higher B/E value, which indicates that the microbial flora balance in the gastrointestinal tract can be better maintained, and the pathogenic bacteria invasion resistance of the patients can be improved.

Compositions 1-9 all reduced the incidence of bloating and constipation recurrence in the subjects. Compared with the blank control group, the compositions 3 to 9 can better relieve the abdominal distension and pain of the constipation patients and show better effect of preventing the recurrence of the constipation.

Compositions 1 to 9 all of which can adsorb Pb²⁺Ions. Compositions 3-9 adsorbed Pb compared to the blank control²⁺The ion effect is better, and toxic and harmful substances (such as Pb) in intestinal tract can be effectively removed²⁺Ions, etc.).

Comprehensively considering the B/E value, the abdominal distention incidence rate, the constipation recurrence rate and the Pb adsorption of the composition²⁺As a result of the ionic ratio and the like, when the mass ratio of the first polymer to the second polymer is 1:3 to 1:6, a better constipation-improving effect can be obtained.

Example 3Sensory evaluation test of the composition of the present invention

90 patients with constipation symptoms of 40-60 years old are selected, including 30 patients with constipation caused by tumor chemotherapy, 30 patients with chronic constipation and 30 patients with constipation caused by enteral nutrition.

90 subjects took the composition 3 of the present invention 2 times/day at 15g each time for 14 consecutive days. The results of sensory evaluation tests of the compositions of the present invention are shown in table 3.

TABLE 3 organoleptic evaluation tests of the compositions of the invention

As can be seen from Table 3, the composition of the present invention has good flavor and taste, and is suitable for preventing and treating various constipation with appropriate dosage.

Example 4 efficacy testing of the compositions of the invention

1. Subject patient

60 subjects with age ranging from 40 to 60 years were selected, 20 of which were non-constipated patients and 40 of which were tumor chemotherapy-associated constipated patients. The tested patients have no intestinal disease within 1 month, and do not take antibiotics, microecological drinks or health care medicines.

40 constipation subjects were randomized into experimental (20) and placebo (20). The 20 non-constipated patients were control groups. The subjects in the experimental group, the placebo group and the control group have no significant difference in age, sex, disease course, disease condition and the like (P > 0.05).

2. Experimental methods

The experimental group took the composition 3 of the present invention daily at an amount of 15g each time for 2 times/day. The placebo group took placebo 2 times a day at 15g each time. The control group was dosed with equal amounts of water without any composition or placebo. The administration is continued for 14 days. During the experiment, the subject diets were normal.

The intestinal flora in the feces of the subjects (control group, experimental group, placebo group) was measured 1 day before the test feeding and 14 days after the administration of the composition, and the number of stools and the stool characteristics before and after the test feeding and in the placebo group were recorded 6 days before the start of the experiment and 14 days after the administration of the composition.

Stool characteristics: is smooth and soft like sausage or snake; like sausage, but with cracks in its surface; soft lumps have distinct edges (easy to exclude) as class i (score 0); ② sausage-shaped but with lumps; loose block shape, rough edge, sludge-like feces is grade II (1 point); thirdly, the separated hard lumps like fruit stones (not easy to discharge) are grade III (2). At the same time, the water content in the feces was measured.

Collecting the feces of the subjects in the experimental group and the placebo group before and after the experiment, and measuring the quantity of the bifidobacteria and the quantity of the enterobacteria in the feces of the subjects, thereby calculating the ratio of the quantity of the bifidobacteria to the quantity of the enterobacteria (B/E value). The results are shown in tables 4 and 5.

TABLE 4 Change of defecation before and after test feeding of the patients

Note:^ap is less than 0.05 after the test eating of the experimental group compared with the p before the test eating;^bafter the test feeding of the experimental group, the p is less than 0.05 compared with that of the placebo group.

TABLE 5 Change in intestinal flora before and after test feeding

Note:^ap is less than 0.05 after the test eating of the experimental group compared with the p before the test eating;^bafter the experimental group is fed with the test food, comparing the p with the control group and being less than 0.05;^cp is more than 0.05 after the placebo group takes the test meal compared with before the test meal.

As can be seen from Table 4, the frequency of stools of the subjects taking the composition 3 of the present invention was increased, the stool characteristics were softened, and the water content of stools was increased, as compared with the placebo group, indicating that the defecation condition was significantly improved.

As can be seen from Table 5, compared with the placebo group, the administration of the composition 3 of the present invention promotes the growth of Lactobacillus and Bifidobacterium (p < 0.05), inhibits the growth of Enterobacter, Staphylococcus, and Saccharomyces (p < 0.05), and the B/E values before and after the test feeding are increased from less than 1 to more than 1, so that the intestinal colonization resistance is significantly enhanced to reach the normal level of the patients without constipation (control group). The composition can maintain the microbial flora balance in the gastrointestinal tract and increase the capability of resisting pathogenic bacteria invasion.

Example 5Efficacy comparison of the compositions of the invention with commercially available products

1. Experimental sample

Selecting 40 cases of patients with tumor chemotherapy-related constipation of 40-60 years old, wherein the patients have no intestinal tract disease within 1 month and do not take antibiotics, microecological drinks or health care medicines.

40 constipation subjects were randomly divided into an experimental group (20 cases) and a control group (20 cases). The experimental group and the control group have no significant difference in age, sex, disease course, disease condition and the like (P > 0.05).

2. Experimental methods

The experimental group took the composition 3 of the present invention daily at an amount of 15g each time for 2 times/day. The control group took lactulose oral liquid (prepared according to IN229MUM2013 example 1) daily at a dose of 30-45mL each time for 1 time/day. The administration is continued for 14 days. During the experiment, the subject diets were normal.

The number of stools and stool characteristics of the subjects (control group, experimental group) before and after the test were examined 6 days before the start of the experiment and 14 days after the administration of the composition, respectively.

Stool characteristics: is smooth and soft like sausage or snake; like sausage, but with cracks in its surface; soft lumps have distinct edges (easy to exclude) as class i (score 0); ② sausage-shaped but with lumps; loose block shape, rough edge, sludge-like feces is grade II (1 point); thirdly, the separated hard lumps like fruit stones (not easy to discharge) are grade III (2).

Recording defecation times and abdominal distension gas production times of test subjects in the experimental group and the control group, collecting feces of the test subjects before and after the experiment, and detecting the moisture content and the feces properties of the tested patients. The results are shown in Table 6.

TABLE 6 Change of defecation before and after eating trial

Note:^ap is more than 0.05 after the test eating of the experimental group compared with the p before the test eating;^bcomparing p is less than 0.05 after the experimental group is fed with the control group;^cthe p of the control group after the test feeding is less than 0.05 compared with the control group before the test feeding.

As can be seen from table 6, when compared with the control group taking the lactulose oral liquid, the gas production frequency of the patients is not increased when the tested patients take the composition 3 of the present invention, the bad feelings such as flatulence and abdominal discomfort are not caused after the administration, and the defecation frequency of the tested patients is increased, the stool properties are softer, and the stool water content is higher. The composition has a treatment effect on constipation related to tumor chemotherapy, which is obviously better than that of lactulose oral liquid.

The experimental results of examples 1-5 show that the composition can obviously improve intestinal flora, reduce the occurrence rate of abdominal distension and the recurrence rate of constipation, adsorb toxic substances in vivo, increase defecation frequency, improve stool character and moisture, does not increase the exhaust frequency of a patient, has good administration feeling of the tested patient, and is suitable for comprehensively improving the constipation symptoms caused by various reasons.

The above description of the specific embodiments of the present invention is not intended to limit the present invention, and those skilled in the art may make various changes and modifications according to the present invention without departing from the spirit of the present invention, which is defined in the appended claims.

Claims

1. The application of the composition in preparing a preparation for preventing and treating tumor-related constipation, constipation and diarrhea alternation is characterized in that the composition consists of 40 parts of effective components and 60 parts of water, wherein the effective components are fructo-oligosaccharide and polydextrose, the polymerization degree of the fructo-oligosaccharide is an integer of 2-20, the polymerization degree of the polydextrose is an integer of 20-500, and the ratio of the fructo-oligosaccharide: the mass ratio of the polydextrose is 1:4.5-1:6, and the pH value of the composition is less than or equal to 4.6.

2. The use according to claim 1, wherein the tumour is selected from any one or a combination of solid and non-solid tumours.

3. The use of claim 2, wherein the solid tumor is selected from any one of gastric cancer, colon cancer, bladder cancer, renal cancer, prostate cancer, breast cancer, lung cancer, brain cancer, bone cancer, pancreatic cancer, liver cancer, bile duct cancer, colorectal cancer or a combination thereof.

4. The use of claim 3, wherein the non-solid tumor is selected from any one of lymphoma, leukemia, or a combination thereof.