Inulin-containing product with function of regulating intestines and stomach as well as preparation method and application of inulin-containing product

Abstract

The invention discloses an inulin-containing product for regulating gastrointestinal functions, which comprises inulin, radix paeoniae rubra, radix rehmanniae, radix scrophulariae, peach kernel, angelica sinensis, radix aucklandiae, pericarpium citri reticulatae, glossy privet fruit, eclipta, rhizoma polygonati, radix polygonati officinalis, fructus perillae and radix peucedani, and discloses a preparation method of the inulin-containing product. The traditional Chinese medicine can clear heat and cool blood, promote blood circulation to remove blood stasis, nourish yin and promote salivation, relax bowel, enrich blood and moisten intestines, regulate qi and invigorate spleen, nourish liver and kidney, tonify qi and nourish yin, and depress lung qi, and has a good heat constipation treatment effect.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine health care, and relates to a product containing inulin for regulating gastrointestinal function, a preparation method thereof and an application thereof. Background Art

[0002] Constipation is a phenomenon of gastrointestinal motility disorder. Feces staying in the large intestine will continuously absorb toxins and moisture and re-enter the body circulation along with the blood. Occasional constipation only causes abdominal distension or discomfort, while long-term constipation will cause symptoms such as fatigue, dizziness or insomnia, heavy head, headache, shoulder soreness, irritability, poor appetite, etc., which have adverse effects on the brain and other organs. For elderly patients with hypertension, coronary heart disease, cerebral arteriosclerosis, etc., straining to defecate may even cause cerebral hemorrhage or myocardial infarction. The prevalence rate of chronic constipation in Chinese adults is 4%-6%, and it increases with age. The prevalence rate of chronic constipation in people over 60 can be as high as 22%. The course of chronic constipation is generally more than 6 months. For transient defecation difficulties or a decrease in the number of bowel movements within a few days, it is usually necessary to first rule out the influence caused by many acute diseases and sudden changes in eating and living habits. Modern medicine believes that the causes of constipation usually include age, bad living habits, mental and psychological factors, intestinal diseases, systemic diseases, and so on.

[0003] CN117442681B provides a traditional Chinese medicine composition for preventing or treating constipation, a preparation method thereof and an application thereof, which comprises the following raw materials in parts by weight: 25-45 parts of Codonopsis pilosula, 12-25 parts of Atractylodes macrocephala, 18-22 parts of Poria cocos, 10-18 parts of stir-fried Sanguisorba officinalis, 5-12 parts of Aquilaria sinensis, 8-15 parts of Lindera aggregata, 5-10 parts of Scrophularia ningpoensis, 3-8 parts of Ophiopogon japonicus, 2-6 parts of Rehmannia glutinosa, 2-8 parts of Medicago sativa, 3-9 parts of Rheum palmatum, 1-5 parts of Aurantii Fructus Immaturus, 2-7 parts of Magnolia officinalis, 1-5 parts of Natrii Sulfas, 2-8 parts of Aucklandia lappa, 2-7 parts of Radix Glycyrrhizae Preparata, 2-6 parts of Bupleurum chinense. According to the compatibility of monarch drugs, ministerial drugs and adjuvant drugs, the active ingredients in the drug are extracted step by step, so that the drug effect can be exerted more fully, the internal microecological environment of the intestine can be effectively improved, the occurrence of constipation can be prevented, and after administration, the constipation symptoms are significantly improved, the number of bowel movements increases, the shape of the stool is normal, and the degree of difficulty in defecation is reduced, effectively preventing or treating the symptoms of excess constipation. However, excess constipation can be divided into heat constipation and qi constipation, and this invention has no pertinence.

[0004] CN117244018B relates to a traditional Chinese medicine composition for treating constipation and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials by weight: 9-15 parts of cistanche deserticola, 5-10 parts of ginseng, 5-12 parts of polygonatum sibiricum, 5-12 parts of chrysanthemum, 3-8 parts of rose, 10-20 parts of almond, 4-10 parts of semen platycladi, 5-12 parts of semen pruni, 6-15 parts of semen armeniacae amarum, 10-20 parts of semen persicae, 5-10 parts of fingered citron, and 3-9 parts of honey. Each component in the traditional Chinese medicine composition of the present invention works together to warm the kidney and replenish essence, soothe the liver, tonify qi and strengthen the spleen, and moisten the intestines and relieve constipation. The traditional Chinese medicine composition for treating constipation has a rapid onset of action, a short course of treatment, and a high total effective rate. It also does not classify and treat constipation.

[0005] Regarding health foods containing inulin, after retrieval, it can be seen that Changqing (China) Daily Necessities Co., Ltd. produces Weilrui Brand Cassia Seed Inulin Soybean Dietary Fiber Powder (Approval Number: G20210019 for Health Food Registration), with main raw materials: soybean dietary fiber powder, inulin, cassia seed extract, containing 25.0 g of total dietary fiber per 100 g, and the health function: laxative; BY-HEALTH Co., Ltd. produces BY-HEALTH Stachyose Inulin Chewable Tablets (Approval Number: G20210020 for Health Food Registration), with main raw materials: stachyose, inulin, containing 28.0 g of stachyose and 8.8 g of total dietary fiber per 100 g, and the health functions: regulating intestinal flora, laxative; Jiangsu Alanoud Nutrition Co., Ltd. produces Alanoud Brand Inulin (Approval Number: G20230003 for Health Food Registration), with main raw material: inulin, containing 86.0 g of dietary fiber per 100 g, and the health function: laxative; Wuhan Innulin Biotechnology Co., Ltd. produces Innulin Brand Inulin Collagen Powder (Approval Number: G20230073 for Health Food Registration), with main raw materials: inulin, hydrolyzed fish collagen, taurine, zinc gluconate, containing 1.4 g of taurine and 65 mg of zinc per 100 g; the health function: this product has been evaluated by animal experiments and has the health function of enhancing immunity; Shanghai Jinhaoer Health Food Co., Ltd. produces Shaner Brand Bovine Colostrum Inulin (Approval Number: G20230507 for Health Food Registration), with main raw materials: bovine colostrum powder, inulin, containing 13 g of immunoglobulin IgG per 100 g, and the health function: this product has been evaluated by animal experiments and has the health function of helping to enhance immunity.

[0006] Inulin is a natural water-soluble dietary fiber supplement, mainly composed of inulin polysaccharide (constituted by fructose molecular chains), and is mainly used to regulate the balance of intestinal flora and improve digestive function. Inulin belongs to prebiotic substances and cannot be directly digested by the human body itself, but can serve as "food" for beneficial bacteria in the intestine, helping to promote the growth of beneficial microorganisms such as Bifidobacterium and Lactobacillus. Inulin is a reserve polysaccharide in plants, mainly derived from plants, and more than 36,000 species have been discovered, including 11 families such as Compositae, Campanulaceae, and Gentianaceae in dicotyledonous plants and Liliaceae and Gramineae in monocotyledonous plants. For example, Jerusalem artichoke tubers, chicory tubers, roots of Dahlia pinnata, and roots of thistles are all rich in inulin, and Jerusalem artichoke has the highest inulin content. It can be seen that the above health foods all utilize the property of inulin containing polysaccharides, ignoring the medicinal properties of the original plants. Jerusalem artichoke is the tuber or stem and leaf of the plant Helianthus tuberosus L. of the genus Helianthus in the Compositae family. It has the effects of clearing heat and cooling blood, and detumescence. It is mainly used to treat febrile diseases, intestinal heat bleeding, traumatic injuries, and fracture swelling and pain. "Compendium of Chinese Herbal Medicines": "Clearing heat and cooling blood, setting bones. Mainly used to treat febrile diseases, intestinal heat diarrhea and bleeding, and traumatic bone injuries." It seems to have nothing to do with laxation. Therefore, it is necessary to develop new health foods using the medicinal properties of the original plant sources. Summary of the Invention

[0007] The object of the present invention is to provide a product containing inulin for regulating gastrointestinal function and its preparation method, which can relieve chronic constipation, improve the health status of the intestine, increase the frequency of active defecation of patients, improve the fecal hardness of patients, change the shape of feces and relieve abdominal distension symptoms, so as to achieve the effect of preventing and treating constipation.

[0008] The technical solution of the present invention is realized as follows:

[0009] A product containing inulin for regulating gastrointestinal function is prepared by extracting the following parts by weight of traditional Chinese medicine raw materials: 20 - 30 parts of inulin, 15 - 25 parts of red peony root, 10 - 20 parts of rehmannia root, 20 - 30 parts of scrophularia root, 10 - 20 parts of peach kernel, 15 - 25 parts of angelica root, 8 - 12 parts of costus root, 20 - 30 parts of dried tangerine peel, 15 - 25 parts of glossy privet fruit, 12 - 18 parts of eclipta prostrata, 15 - 25 parts of polygonatum rhizome, 15 - 25 parts of odoratum rhizome, 8 - 12 parts of perilla seed, 10 - 20 parts of Peucedanum praeruptorum.

[0010] The product containing inulin for regulating gastrointestinal function is prepared by extracting the following parts by weight of traditional Chinese medicine raw materials: 25 parts of inulin, 20 parts of red peony root, 15 parts of rehmannia root, 25 parts of scrophularia root, 15 parts of peach kernel, 20 parts of angelica root, 10 parts of costus root, 25 parts of dried tangerine peel, 20 parts of glossy privet fruit, 15 parts of eclipta prostrata, 20 parts of polygonatum rhizome, 20 parts of odoratum rhizome, 10 parts of perilla seed, 15 parts of Peucedanum praeruptorum.

[0011] The gastrointestinal function regulating product containing inulin is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 20 parts of inulin, 25 parts of red peony root, 10 parts of raw rehmannia, 30 parts of Scrophularia, 10 parts of peach kernel, 25 parts of angelica, 8 parts of costus root, 30 parts of dried tangerine peel, 15 parts of Ligustrum lucidum fruit, 18 parts of Eclipta prostrata, 15 parts of polygonatum, 25 parts of polygonatum, 8 parts of perilla seed, and 20 parts of peucedanum.

[0012] The gastrointestinal function regulating product containing inulin is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 30 parts of inulin, 15 parts of red peony root, 20 parts of raw rehmannia, 20 parts of figwort, 20 parts of peach kernel, 15 parts of angelica, 12 parts of costusroot, 20 parts of dried tangerine peel, 25 parts of glossy privet fruit, 12 parts of eclipta prostrata, 25 parts of polygonatum, 15 parts of polygonatum, 12 parts of perilla seed, and 10 parts of peucedanum.

[0013] The preparation method of the gastrointestinal function regulating product containing inulin comprises the following steps:

[0014] (1) The preparation method of inulin is as follows: Jerusalem artichokes are selected, washed, dried to a moisture content of ≤8%, coarsely crushed to 100-120 mesh, sterilized at a constant temperature of 60-80°C, irradiated with 1200-1600W ultraviolet rays for 15-25 minutes to enhance the fragility of cell walls, crushed by a high-frequency vibration mill at an ultra-low temperature of -50°C, the temperature is controlled at ≤10°C, the crushing time is 1-3 hours, the particle size reaches 2.5-5μm, and the cell wall breaking rate is ≥98%;

[0015] (2) washing, slicing and drying peach kernel, angelica sinensis, costusroot, dried orange peel, perilla seed and peucedanum chinense to a moisture content of 8-12%, then freezing and embrittlement in an ultra-low temperature environment below -50°C for 30-60 minutes, crushing with an ultra-fine grinder under a nitrogen protection environment, controlling the equipment temperature at -30°C to -50°C, and crushing for 5-15 minutes, and finally obtaining 100-300 mesh fine powder through a grading system, and the whole process needs to cooperate with a refrigeration system to maintain a low temperature environment;

[0016] (3) Wash and slice red peony root, raw rehmannia root, Scrophularia ningpoensis, Ligustrum lucidum, Eclipta prostrata, Polygonatum sibiricum, and Polygonatum odoratum, and then crush them to a particle size of 1-3 mm. Then, the materials are fed into an air flow milling chamber through a closed feeding system, and nitrogen gas is used at a pressure of 0.7-0.8 MPa through a supersonic nozzle at a speed of ≥ 2.5 Mach to form a high-speed airflow, so that the material particles collide, rub, and shear violently. The crushed fine powder passes through a built-in centrifugal classifying wheel at a speed of 5000 r / min, and the coarse particles return to the milling chamber for cyclic treatment, and qualified fine powder is collected;

[0017] (4) The powders of steps (1), (2) and (3) are combined and mixed to prepare a powder.

[0018] The preparation method of the gastrointestinal function regulating product containing inulin comprises the following steps:

[0019] (1) The preparation method of inulin is as follows: Jerusalem artichoke is selected, washed, dried to a moisture content of ≤8%, coarsely crushed to 110 mesh, sterilized at 70°C, irradiated with 1500W ultraviolet light for 20 minutes to enhance the fragility of the cell wall, crushed by a high-frequency vibration mill at -50°C ultra-low temperature, the temperature is controlled at ≤10°C, the crushing time is 2 hours, the particle size reaches 4 μm, and the cell wall breaking rate is ≥98%;

[0020] (2) washing, slicing and drying peach kernel, angelica sinensis, costusroot, dried orange peel, perilla seed and peucedanum chinense to a moisture content of 10%, then freezing and embrittlement in an ultra-low temperature environment below -50°C for 45 minutes, crushing with an ultra-fine grinder in a nitrogen protection environment, controlling the equipment temperature at -40°C, and crushing for 10 minutes, and finally obtaining 200 mesh fine powder through a grading system, and the whole process needs to cooperate with a refrigeration system to maintain a low temperature environment;

[0021] (3) Wash and slice red peony root, raw rehmannia root, Scrophularia ningpoensis, Ligustrum lucidum, Eclipta prostrata, Polygonatum sibiricum, and Polygonatum odoratum, and then crush them into a particle size of 1-3 mm. Then, the materials are fed into an air flow milling chamber through a closed feeding system, and nitrogen gas is used at a pressure of 0.75 MPa through a supersonic nozzle at a speed of ≥ 2.5 Mach to form a high-speed airflow, so that the material particles collide, rub, and shear violently. The fine powder after crushing passes through a built-in centrifugal classifying wheel at a speed of 5000 r / min, and the coarse particles return to the milling chamber for cyclic treatment, and qualified fine powder is collected;

[0022] (4) The powders of steps (1), (2) and (3) are combined and mixed to prepare a powder.

[0023] The inulin-containing gastrointestinal function regulating product is used in the preparation of a constipation improving product.

[0024] The inulin-containing product for regulating gastrointestinal function is used in the preparation of a product for improving constipation, wherein the constipation belongs to the heat-constipation syndrome type.

[0025] The Jerusalem artichoke is the tuber or stem and leaf of Helianthus tuberosus L., a plant of the genus Helianthus in the Asteraceae family. It has the effects of clearing heat, cooling blood, and reducing swelling. It is mainly used to treat febrile diseases, intestinal heat bleeding, traumatic injuries, and swelling and pain in fractures. The root of Aucklandia lappa Decne. is the root of Aucklandia lappa Decne., a plant of the genus Aucklandia in the Asteraceae family. It has the effects of promoting qi and relieving pain, regulating the middle and removing stagnation. It is mainly used to treat chest and flank distension, abdominal distension and pain, vomiting and diarrhea, and heaviness after diarrhea. The rest are in line with the standards of the Chinese Pharmacopoeia.

[0026] Traditional Chinese medicine believes that the location of constipation is in the large intestine, which is related to the dysfunction of the functions of the lungs, spleen (stomach), liver, and kidneys. As early as in "Huangdi Neijing", constipation was called "difficulty in defecation" and "difficulty in having a bowel movement". In "Treatise on Febrile and Miscellaneous Diseases" written by Zhang Zhongjing in the Han Dynasty, constipation was called "spleen constraint". In "Jingyue Quanshu · Secret Constipation Chapter", constipation was divided into yang constipation and yin constipation. The name "constipation" first appeared in "Miscellaneous Diseases: Origins and Development" written by Shen Jin'ao in the Qing Dynasty and has been used until now. The TCM syndrome differentiation types of constipation mainly include heat constipation, qi constipation, cold constipation, qi deficiency constipation, blood deficiency constipation, yin deficiency constipation, yang deficiency constipation, etc. There may also be syndromes of intermingled cold and heat, deficiency and excess due to the evolution of specific etiologies and pathogenesis. Among them, heat constipation is caused by internal heat accumulation due to constitutional yin deficiency, excessive alcohol consumption, overeating spicy and rich foods, or taking wrong drugs; or after febrile diseases, the residual heat lingers; or the dryness and heat of the lungs and lung heat descend to the large intestine, which can all lead to the accumulation of heat in the intestines and stomach, consuming body fluids, resulting in dry and constipated intestines, thus forming heat constipation. Symptoms: Dry stools, short and red urine, flushed face and restlessness, or fever, dry mouth and bad breath, abdominal distension or pain. Red tongue with yellow and dry coating, slippery and rapid pulse.

[0027] "Medical Treatise on Secret Constipation" states: "Examining its origin, it is all due to excessive sexual indulgence, improper diet, or excessive drinking of alcohol, overeating spicy and hot foods. The fire from diet starts in the spleen and stomach, and the fire from lust starts in the mingmen, resulting in excessive fire and deficiency of water, and the body fluids are not generated, so the transmission function is abnormal and gradually forms the syndrome of dryness and constipation." It clearly points out some causes of this disease. "Medical Introduction · Dryness and Constipation of Stools" says: "Dryness belongs to the deficiency of the body fluids of Shaoyin, and it should be moistened with pungent herbs; constipation belongs to the presence of dry feces in Taiyin, and it should be purged with bitter herbs." For heat constipation, this invention selects inulin to clear heat and cool the blood, reduce swelling, red peony root to clear heat and cool the blood, promote blood circulation and remove stasis, and rehmannia root and scrophularia root to nourish yin and promote the production of body fluids, which together serve as the sovereign herbs.

[0028] Heat constipation is the so-called yang constipation in ancient times. The main pathogenesis is the accumulation of heat in the intestines and stomach. Due to the accumulation of heat in the intestines and stomach, or the residual pathogenic factors of febrile diseases not being cleared, consuming body fluids, the intestines become dry and constipated: the accumulated heat rises, and the turbid yin fails to descend, so there is dry mouth and bad breath; the heat is excessive inside, so there is restlessness, flushed face, and fever; the heat transfers to the bladder, so the urine is short and red. The red tongue with yellow and dry coating and the slippery and rapid pulse are signs of heat consuming body fluids. Select peach kernels: promote blood circulation and remove stasis, moisten the intestines and relieve constipation, relieve cough and asthma. Angelica sinensis: nourish blood and moisten the intestines, and treat constipation due to blood deficiency and dryness of the intestines.

[0029] Traditional Chinese medicine believes that "the spleen is in charge of transportation and transformation", responsible for the absorption and distribution of food essence. If the functions of the spleen and stomach are disordered, the retention of water-dampness or the endogenous generation of damp-heat can affect the intestinal conduction function, leading to the internal binding of dry heat. The normal transportation and transformation function of the spleen is the basis for the conduction of the large intestine. If there is qi stagnation due to spleen deficiency and insufficient intestinal motility, even if there is heat binding, defecation will still be difficult. The spleen is the "foundation of acquired constitution", and spleen-strengthening drugs can promote the generation of body fluids, moisten the intestines, and relieve the intestinal dryness caused by fluid deficiency. Spleen deficiency with excessive dampness is prone to the generation of damp-heat, and the downward flow of damp-heat into the intestines can aggravate constipation. Regulating qi and strengthening the spleen can reduce the generation of damp-heat and indirectly improve the symptoms of heat constipation. Therefore, Aucklandia lappa and tangerine peel are selected to regulate qi and strengthen the spleen, and together with the above-mentioned peach kernels and angelica sinensis, they serve as the ministerial herbs.

[0030] In the Qing Dynasty, "The Origins and Treatises of Miscellaneous Diseases: The Origins and Treatises of Constipation" emphasized that "constipation is a kidney disease". Since the kidney is in charge of the five fluids and opens into the anterior and posterior yin, it is believed that constipation should be treated from the kidney. In addition to general syndrome differentiation and treatment, it also introduced therapeutic exercises for constipation. As quoted in the same chapter from "The Secret Essentials of Health Preservation", it is said that by pressing the tongue against the upper palate, keeping the uvula in mind, and quietly concentrating, saliva will be generated naturally. When the mouth is full, stir the tongue like a red dragon, gargle frequently and swallow frequently, and listen for it to descend straight to the dantian. Then keep quiet and swallow several times, and the large intestine will naturally moisten. The effects will be seen after practice. " Ligustrum lucidum is selected to nourish the liver and kidney, clear heat and improve eyesight, Eclipta prostrata is used to cool blood and stop bleeding, nourish the liver and kidney, and Polygonatum sibiricum and Polygonatum odoratum are used to boost qi and nourish yin, strengthen the spleen, moisten the lungs and benefit the kidney, and they are all adjuvant drugs.

[0031] In the Qing Dynasty, "The Secret Records of the Stone Chamber: Constipation of the Large Intestine" stated: "For those with constipation of the large intestine, people think it is due to excessive dryness of the large intestine. Who would know that it is due to dryness of the lung qi? When the lung qi is dry, the clear and descending qi cannot descend to the large intestine." It pointed out that constipation is related to the lung. Perilla seed is selected to lower qi and resolve phlegm, relieve cough and asthma, and Peucedanum praeruptorum is used to lower qi and resolve phlegm, disperse wind-heat, and lower the lung qi to promote defecation, and they are both envoy drugs.

[0032] The whole formula contains inulin, Paeonia lactiflora, Rehmannia glutinosa, Scrophularia ningpoensis, Prunus persica, Angelica sinensis, Aucklandia lappa, Citrus reticulata, Ligustrum lucidum, Eclipta prostrata, Polygonatum sibiricum, Polygonatum odoratum, Perilla seed, and Peucedanum praeruptorum, and can clear heat and cool blood, promote blood circulation to remove stasis, nourish yin and promote fluid production, moisten the intestines and relieve constipation, nourish blood and moisten the intestines, regulate qi and strengthen the spleen, nourish the liver and kidney, boost qi and nourish yin, and lower the lung qi, and has a good effect in treating heat constipation.

[0033] During the research on the preparation method of the present invention, it was found that if the traditional Chinese medicine raw materials in the prescription are extracted with water or alcohol and then spray-dried or dried at low temperature, they will absorb moisture after being placed for a period of time. If made into powder, it is easy to agglomerate, which may be related to the fact that components such as sugars and proteins in the extract powder are easy to absorb water. Therefore, after a large number of experiments, the extraction method was improved. In the extraction of inulin, the Jerusalem artichoke is first dried and then crushed at low temperature to achieve the purpose of cell wall breaking; for Prunus persica, Angelica sinensis, Aucklandia lappa, Citrus reticulata, Perilla seed, and Peucedanum praeruptorum containing volatile oils, they are frozen and embrittled and then ultra-finely crushed at low temperature to retain the volatile oil components to the greatest extent, and the other traditional Chinese medicines are crushed by air flow. The combined powder has good appearance uniformity, good fluidity, low water content, uniform particle size, and a long shelf life.

[0034] Pharmacodynamic experiments showed that in the constipation model group, the fecal water content (%) was significantly reduced, the time to the first black stool excretion (min) was significantly prolonged, and the intestinal propulsion rate (%) was significantly shortened, indicating that the model was successfully established. And the powder for treating heat constipation prepared in Example 1 of the present invention could significantly improve the constipation symptoms of constipated rats, and the effect was better than that of the positive drug group.

[0035] Clinical research showed that in the group of Example 1 of the present invention, 16 cases were cured, 15 cases were markedly effective, 16 cases were effective, and 3 cases were ineffective, with an effective rate of 96%; in the control group, 12 cases were cured, 18 cases were markedly effective, 12 cases were effective, and 8 cases were ineffective, with an effective rate of 84%; it showed that the present invention has a better effect in treating heat constipation than Maren Pills in the control group. Specific Embodiments

[0036] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0037] Embodiment 1:

[0038] Take 25g of inulin, 20g of red peony root, 15g of raw rehmannia, 25g of Scrophularia, 15g of peach kernel, 20g of angelica, 10g of costusroot, 25g of dried orange peel, 20g of Ligustrum lucidum, 15g of Eclipta prostrata, 20g of polygonatum, 20g of polygonatum, 10g of perilla seed, and 15g of peucedanum, and the preparation method comprises the following steps:

[0039] (1) The preparation method of inulin is as follows: Jerusalem artichoke is selected, washed, dried to a moisture content of ≤8%, coarsely crushed to 110 mesh, sterilized at 70°C, irradiated with 1500W ultraviolet light for 20 minutes to enhance the fragility of the cell wall, crushed by a high-frequency vibration mill at -50°C ultra-low temperature, the temperature is controlled at ≤10°C, the crushing time is 2 hours, the particle size reaches 4 μm, and the cell wall breaking rate is ≥98%;

[0040] (2) washing, slicing and drying peach kernel, angelica sinensis, costusroot, dried orange peel, perilla seed and peucedanum chinense to a moisture content of 10%, then freezing and embrittlement in an ultra-low temperature environment below -50°C for 45 minutes, crushing with an ultra-fine grinder in a nitrogen protection environment, controlling the equipment temperature at -40°C, and crushing for 10 minutes, and finally obtaining 200 mesh fine powder through a grading system, and the whole process needs to cooperate with a refrigeration system to maintain a low temperature environment;

[0041] (3) Wash and slice red peony root, raw rehmannia root, Scrophularia ningpoensis, Ligustrum lucidum, Eclipta prostrata, Polygonatum sibiricum, and Polygonatum odoratum, and then crush them into a particle size of 1-3 mm. Then, the materials are fed into an air flow milling chamber through a closed feeding system, and nitrogen gas is used at a pressure of 0.75 MPa through a supersonic nozzle at a speed of ≥ 2.5 Mach to form a high-speed airflow, so that the material particles collide, rub, and shear violently. The fine powder after crushing passes through a built-in centrifugal classifying wheel at a speed of 5000 r / min, and the coarse particles return to the milling chamber for cyclic treatment, and qualified fine powder is collected;

[0042] (4) The powders of steps (1), (2) and (3) are combined and mixed to prepare a powder.

[0043] Embodiment 2:

[0044] Take 30 g of inulin, 15 g of red peony root, 20 g of rehmannia root, 20 g of scrophularia root, 20 g of peach kernel, 15 g of angelica sinensis, 12 g of costus root, 20 g of dried tangerine peel, 25 g of glossy privet fruit, 12 g of eclipta prostrata, 25 g of polygonatum sibiricum, 15 g of polygonatum odoratum, 12 g of perilla seed, and 10 g of peucedanum praeruptorum. The preparation method comprises the following steps:

[0045] (1) The preparation method of inulin is as follows: Take Jerusalem artichoke, pick and wash it, then dry it until the water content ≤ 8%, coarsely crush it to 100 mesh, sterilize it at a constant temperature of 80 °C, irradiate it with 1200 W ultraviolet light for 25 minutes to enhance the brittleness of cell walls, in a -50 °C ultra-low temperature environment, use a high-frequency vibration mill to crush it, control the temperature ≤ 10 °C, and the crushing time is 1 hour to make the particle size reach 5 μm and the cell wall breaking rate ≥ 98%;

[0046] (2) Take peach kernel, angelica sinensis, costus root, dried tangerine peel, perilla seed, and peucedanum praeruptorum, wash, slice and dry them until the water content is 8%, then place them in an ultra-low temperature environment below -50 °C for 60 minutes for freezing and embrittlement, and use an ultrafine pulverizer to crush them under a nitrogen protection environment. Control the equipment temperature at -30 °C and the crushing time at 15 minutes. Finally, obtain 100-mesh fine powder through a classification system. The whole process needs to be accompanied by a refrigeration system to maintain a low-temperature environment;

[0047] (3) Take red peony root, rehmannia root, scrophularia root, glossy privet fruit, eclipta prostrata, polygonatum sibiricum, and polygonatum odoratum, wash and slice them, and coarsely crush them to a particle size of 3 mm. Then, send the materials into a jet milling chamber through a closed feeding system, use nitrogen with a pressure of 0.7 Mpa, and form a high-speed air flow with a speed ≥ 2.5 Mach through a supersonic nozzle, so that the material particles collide, rub and shear violently. The crushed fine powder passes through an internal centrifugal classification wheel with a rotation speed of 5000 r / min, and the coarse particles return to the milling chamber for cyclic treatment, and the qualified fine powder is collected;

[0048] (4) Combine the powders obtained in the above steps (1), (2), and (3), mix them, and prepare them into a powder.

[0049] Example 3:

[0050] Take 20 g of inulin, 25 g of red peony root, 10 g of rehmannia root, 30 g of scrophularia root, 10 g of peach kernel, 25 g of angelica sinensis, 8 g of costus root, 30 g of dried tangerine peel, 15 g of glossy privet fruit, 18 g of eclipta prostrata, 15 g of polygonatum sibiricum, 25 g of polygonatum odoratum, 8 g of perilla seed, and 20 g of peucedanum praeruptorum. The preparation method comprises the following steps:

[0051] (1) The preparation method of inulin is as follows: Take Jerusalem artichoke, pick and wash it, then dry it until the water content ≤ 8%, coarsely crush it to 120 mesh, sterilize it at a constant temperature of 60 °C, irradiate it with 1600 W ultraviolet light for 15 minutes to enhance the brittleness of cell walls, in a -50 °C ultra-low temperature environment, use a high-frequency vibration mill to crush it, control the temperature ≤ 10 °C, and the crushing time is 3 hours to make the particle size reach 2.5 μm and the cell wall breaking rate ≥ 98%;

[0052] (2) Take peach kernels, angelica, costus root, tangerine peel, perilla seeds, and white hogfennel, wash, slice, and dry them to a moisture content of 12%. Then place them in an ultra-low temperature environment below -50°C and freeze and embrittle for 30 minutes. Use an ultrafine grinder to pulverize them under a nitrogen protection environment. Control the equipment temperature at -50°C and the pulverization time at 5 minutes. Finally, obtain 300-mesh fine powder through a classification system. The whole process requires cooperation with a refrigeration system to maintain a low-temperature environment;

[0053] (3) Take red peony root, rehmannia root, scrophularia root, glossy privet fruit, eclipta prostrata, polygonatum sibiricum, and odoratissimum, wash and slice them, and preliminarily pulverize them to a particle size of 1 mm. Then send the materials into the air pulverization chamber through a closed feeding system. Use nitrogen with a pressure of 0.8 Mpa. Through a supersonic nozzle with a speed ≥ 2.5 Mach, form a high-speed air flow to cause violent collision, friction, and shear between the material particles. The pulverized fine powder passes through an internal centrifugal classification wheel with a rotation speed of 5000 r / min. The coarse particles return to the pulverization chamber for cyclic treatment, and the qualified fine powder is collected;

[0054] (4) Combine the powders obtained in the above steps (1), (2), and (3), mix them, and prepare them into a powder.

[0055] Comparative Example 1:

[0056] Take 25 g of inulin, 20 g of red peony root, 15 g of rehmannia root, 25 g of scrophularia root, 15 g of peach kernels, 20 g of angelica, 10 g of costus root, 25 g of tangerine peel, 20 g of glossy privet fruit, 15 g of eclipta prostrata, 20 g of polygonatum sibiricum, 20 g of odoratissimum, 10 g of perilla seeds, and 15 g of white hogfennel. The preparation method includes the following steps:

[0057] (1) The preparation method of inulin is: take Jerusalem artichoke and pulverize it into inulin;

[0058] (2) Take red peony root, rehmannia root, scrophularia root, peach kernels, angelica, costus root, tangerine peel, glossy privet fruit, eclipta prostrata, polygonatum sibiricum, odoratissimum, perilla seeds, and white hogfennel, add 10 times the amount of water and decoct twice, 2 hours each time. Combine the filtrates, concentrate, and spray-dry to obtain fine powder;

[0059] (3) Combine the powders obtained in the above steps (1) and (2), mix them, and prepare them into a powder.

[0060] Example 4: Stability Observation Experiment of the Invention

[0061] Simulate the long-term storage environment through high-temperature and high-humidity conditions (40°C / 75% RH condition), place for six months, and observe in combination with the physical stability (caking) and chemical stability (water content) indicators. The results are shown in Table 1.

[0062] Table 1 Results of the Stability Test of the Invention

[0063]

[0064] As can be seen from the above table, after the traditional Chinese medicine raw materials in the prescription are extracted with water and then spray-dried, the powder will have a high water content, absorb moisture and caking after 6 months of acceleration. This may be related to the fact that components such as sugar and protein in the extract powder are easy to absorb water. In the extraction of inulin in the present invention, the Jerusalem artichoke is first dried and then pulverized at low temperature to achieve the purpose of cell wall breaking; for peach kernel, angelica, costus root, tangerine peel, perilla seed, and whiteflower hogfennel with volatile oil, they are cryo-brittle and then ultra-finely pulverized at low temperature to retain the volatile oil components to the greatest extent. Other traditional Chinese medicines are pulverized by air flow. The combined powder has good appearance uniformity, good fluidity, low water content, uniform particle size, and long shelf life.

[0065] Example 5:

[0066] SPF-grade SD rats were selected and adaptively fed for 1 week. Randomly select 10 rats as the blank group, and the remaining rats were all modeled. They were intragastrically administered 15 mg / kg of compound diphenoxylate once a day for 1 month to establish a constipation rat model. The modeling was successful when the following symptoms appeared in the modeled rats: compared with the rats in the blank group, the body weight of the modeled rats was significantly reduced, and the water content of the feces and the number of feces in 24 h were both significantly reduced. The modeled rats were randomly divided into a model group, an Example 1 group, and a positive drug group (Maren Pills, national drug approval number Z20054708, Nanjing Tongrentang Pharmaceutical Co., Ltd.), with 10 rats in each group. The model group was given distilled water by gavage, 8 mL / (kg·d) per rat, twice a day, with a 4-hour interval between the two administrations; the Example 1 group was given the powder prepared in Example 1, 8 g of crude drug amount / (kg·d) per rat, twice a day, and the positive drug group was given Maren Pills, 8 g / (kg·d) per rat, twice a day, with a 4-hour interval between the two administrations; each group was continuously administered for 30 days.

[0067] 1. Detection of fecal moisture content: After the experiment, take the 24-hour feces of rats in each group, first weigh its wet weight, and then put it in an oven to dry and then weigh the dry weight of the feces, and calculate the fecal moisture content:

[0068] Moisture content (%) = (fecal wet weight - fecal dry weight) / fecal wet weight × 100%.

[0069] 2. Detection of the time of the first black feces excretion

[0070] After the modeling, randomly select 4 rats from each group and intragastrically administer India ink (2 mL per rat), record and calculate the time from the intragastric administration time to the excretion of the first black feces, and calculate the time of the first black feces excretion:

[0071] Time of the first black feces excretion (min) = time point of the first black feces excretion - time point of India ink intragastric administration

[0072] 3. Detection of intestinal propulsion rate

[0073] After the establishment of the model, rats in each group were fasted but allowed to drink water for 12 h. Four rats were randomly selected and gavaged with India ink (2 mL per rat). After 2 h, the rats were anesthetized with 20 wt% urethane and sacrificed. The intestines were dissected, and the total length from the pylorus to the ileocecal junction and the distance of the ink propulsion in the intestine (the distance from the pylorus to the front end of the ink propulsion) were measured with a ruler. The intestinal propulsion rate was calculated as follows: intestinal propulsion rate (%) = propulsion distance / total length from the pylorus to the ileocecal junction × 100%. The results are shown in Table 2.

[0074] Table 2 Efficacy observation of the present invention on constipated model rats

[0075] Group Fecal moisture content (%) Time of the first black stool excretion (min) Intestinal propulsion rate (%) Blank group 64.8±15.5 252.8±45.1 73.1±26.8 Model group <![CDATA[23.9±14.8 ## > <![CDATA[812.4±76.9 ## > <![CDATA[36.9±18.2 ## > Example 1 group <![CDATA[57.3±9.6 ** > <![CDATA[347.8±62.8 ** > <![CDATA[63.2±11.5 ** > Positive drug group <![CDATA[47.7±12.7 * > <![CDATA[472.0±71.4 * > <![CDATA[51.4±18.5 * >

[0076] Compared with the blank group, ## P < 0.01. Compared with the model group * P < 0.05, ** P < 0.01

[0077] As can be seen from the above table, the water content rate (%) of feces in the constipated model group was significantly decreased, the time of the first black stool excretion (min) was significantly prolonged, and the intestinal propulsion rate (%) was significantly shortened, indicating that the model was successfully established. The powder for treating heat constipation prepared in Example 1 of the present invention could significantly improve the constipation symptoms of constipated rats, and the effect was better than that of the positive drug group of Maren Pills.

[0078] Example 6: Clinical observation

[0079] General information: A total of 100 cases were observed from 2020 to 2023. The youngest age was 26 years old, the oldest was 77 years old, and the average age was 52 years old; 55 were male and 45 were female. They were randomly divided into the Example 1 group and the control group.

[0080] Diagnostic criteria: Refer to the relevant standards in the "Guiding Principles for Clinical Research of New Chinese Medicines": The defecation time is prolonged, the interval between each defecation is more than 72 h, the stool quality is dry and hard, even like sheep dung or lumps, and it is difficult to defecate and discharge. And it belongs to the heat constipation syndrome in traditional Chinese medicine syndrome differentiation: The symptoms include dry stools, short and red urine, flushed face and restlessness, or fever, dry mouth and bad breath, abdominal distension or pain. The tongue is red with yellow and dry coating, and the pulse is slippery and rapid.

[0081] Exclusion criteria: (1) Those with intestinal stenosis caused by organic lesions of the rectum and colon (such as tumors, Crohn's disease, colonic polyps, intestinal tuberculosis, etc.) confirmed by examination. (2) Those with severe primary diseases of the cardiovascular, liver, kidney and hematopoietic systems, and psychiatric patients. (3) Those who do not meet the inclusion criteria, do not take medicine as prescribed, cannot judge the curative effect, or have incomplete data, etc., which affect the judgment of curative effect and safety.

[0082] Treatment method: The patients in Example 1 group took the powder prepared in Example 1, with the daily dosage of 25 g of inulin, 20 g of radix paeoniae rubra, 15 g of radix rehmanniae, 25 g of scrophulariae, 15 g of semen persicae, 20 g of angelicae sinensis, 10 g of costus root, 25 g of pericarpium citri reticulatae, 20 g of fructus ligustri lucidi, 15 g of ecliptae, 20 g of polygonati rhizoma, 20 g of odoratissime, 10 g of semen perillae, and 15 g of peucedani. It was taken three times a day for 15 consecutive days. The control group took Maren Pills (National Medicine Approval Number: Z20054708, Nanjing Tongrentang Pharmaceutical Co., Ltd.), 6 g each time, twice a day for 15 consecutive days.

[0083] Efficacy criteria: It was formulated according to the relevant criteria in "Guiding Principles for Clinical Research of New Chinese Medicines". Recovery: Normal bowel movements, or restored to the level before the illness, and all other symptoms disappeared. Marked effect: Constipation was significantly improved, and the interval time and stool quality were normal; or the stool was slightly dry and the defecation interval was within 72 hours, and most of the other symptoms disappeared. Effective: The defecation interval was shortened by 1 day, or the dryness of the stool was improved, and other symptoms were all improved. Ineffective: There was no improvement in constipation and other symptoms. The results are shown in Table 3.

[0084] Table 3 Efficacy Observation

[0085] Group Cured Markedly effective Effective Ineffective Effective rate (%) Example 1 group 16 15 16 3 96 Control group 12 18 12 8 84

[0086] As can be seen from the above table, in the Example 1 group, 16 cases were recovered, 15 cases had marked effect, 16 cases were effective, and 3 cases were ineffective, with an effective rate of 96%; in the control group, 12 cases were recovered, 18 cases had marked effect, 12 cases were effective, and 8 cases were ineffective, with an effective rate of 84%. It shows that the treatment of heat constipation by the present invention is better than that of the control group.

[0087] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A product containing inulin for regulating gastrointestinal function, characterized in that, The invention is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 20-30 parts of inulin, 15-25 parts of red peony root, 10-20 parts of raw rehmannia, 20-30 parts of figwort, 10-20 parts of peach kernel, 15-25 parts of angelica, 8-12 parts of costusroot, 20-30 parts of tangerine peel, 15-25 parts of privet fruit, 12-18 parts of Eclipta prostrata, 15-25 parts of polygonatum, 15-25 parts of polygonatum, 8-12 parts of perilla seed and 10-20 parts of peucedanum.

2. The inulin-containing product for regulating gastrointestinal function according to claim 1, characterized in that, The preparation method is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 25 parts of inulin, 20 parts of red peony root, 15 parts of raw rehmannia, 25 parts of figwort, 15 parts of peach kernel, 20 parts of angelica, 10 parts of costusroot, 25 parts of tangerine peel, 20 parts of Ligustrum lucidum, 15 parts of Eclipta prostrata, 20 parts of polygonatum, 20 parts of polygonatum, 10 parts of perilla seed, and 15 parts of peucedanum.

3. The inulin-containing product for regulating gastrointestinal function according to claim 1, wherein The preparation method is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 20 parts of inulin, 25 parts of red peony root, 10 parts of raw rehmannia, 30 parts of Scrophularia, 10 parts of peach kernel, 25 parts of angelica, 8 parts of costusroot, 30 parts of dried tangerine peel, 15 parts of Ligustrum lucidum, 18 parts of Ecliptae, 15 parts of Polygonatum, 25 parts of Polygonatum, 8 parts of Perilla seed, and 20 parts of Peucedanum peucedanum.

4. The inulin-containing product for regulating gastrointestinal function according to claim 1, characterized in that, The preparation method is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 30 parts of inulin, 15 parts of red peony root, 20 parts of raw rehmannia, 20 parts of figwort, 20 parts of peach kernel, 15 parts of angelica, 12 parts of costusroot, 20 parts of tangerine peel, 25 parts of glossy privet fruit, 12 parts of eclipta prostrata, 25 parts of polygonatum, 15 parts of polygonatum, 12 parts of perilla seed, and 10 parts of peucedanum.

5. The inulin-containing product for regulating gastrointestinal function according to claim 1, wherein The preparation method comprises the following steps: (1) The preparation method of inulin is as follows: Jerusalem artichokes are selected, washed, dried to a moisture content of ≤8%, coarsely crushed to 100-120 mesh, sterilized at a constant temperature of 60-80°C, irradiated with 1200-1600W ultraviolet rays for 15-25 minutes to enhance the fragility of cell walls, crushed by a high-frequency vibration mill at an ultra-low temperature of -50°C, the temperature is controlled at ≤10°C, the crushing time is 1-3 hours, the particle size reaches 2.5-5μm, and the cell wall breaking rate is ≥98%; (2) washing, slicing and drying peach kernel, angelica sinensis, costusroot, dried orange peel, perilla seed and peucedanum chinense to a moisture content of 8-12%, then freezing and embrittlement in an ultra-low temperature environment below -50°C for 30-60 minutes, crushing with an ultra-fine grinder under a nitrogen protection environment, controlling the equipment temperature at -30°C to -50°C, and crushing for 5-15 minutes, and finally obtaining 100-300 mesh fine powder through a grading system, and the whole process needs to cooperate with a refrigeration system to maintain a low temperature environment; (3) Wash and slice red peony root, raw rehmannia root, Scrophularia ningpoensis, Ligustrum lucidum, Eclipta prostrata, Polygonatum sibiricum, and Polygonatum odoratum, and then crush them to a particle size of 1-3 mm. Then, the materials are fed into an air flow milling chamber through a closed feeding system, and nitrogen gas is used at a pressure of 0.7-0.8 MPa through a supersonic nozzle at a speed of ≥ 2.5 Mach to form a high-speed airflow, so that the material particles collide, rub, and shear violently. The crushed fine powder passes through a built-in centrifugal classifying wheel at a speed of 5000 r / min, and the coarse particles return to the milling chamber for cyclic treatment, and qualified fine powder is collected; (4) The powders of steps (1), (2) and (3) are combined and mixed to prepare a powder.

6. The inulin-containing product for regulating gastrointestinal function according to claim 5, characterized in that, The preparation method comprises the following steps: (1) The preparation method of inulin is as follows: Select Jerusalem artichokes, pick and wash them, then dry them until the moisture content is ≤ 8%, coarsely pulverize them to 110 meshes, sterilize them at a constant temperature of 70 °C, irradiate them with 1500 W ultraviolet rays for 20 minutes to enhance the brittleness of cell walls, and under the ultra-low temperature environment of -50 °C, use a high-frequency vibration mill to pulverize them, control the temperature ≤ 10 °C, and the pulverization time is 2 hours to make the particle size reach 4 μm and the cell wall breaking rate ≥ 98%; (2) Select peach kernels, angelica, costus root, tangerine peel, perilla seeds, and hogfennel, wash, slice them and dry them until the moisture content is 10%, then place them in an ultra-low temperature environment below -50 °C for 45 minutes for freeze embrittlement, and use an ultrafine pulverizer to pulverize them under a nitrogen protection environment, control the equipment temperature at -40 °C, and the pulverization time is 10 minutes. Finally, obtain 200-mesh fine powder through a classification system, and the whole process needs to be combined with a refrigeration system to maintain a low temperature environment; (3) Select red peony roots, rehmannia roots, scrophularia roots, glossy privet fruits, eclipta prostrata, polygonatum rhizomes, and odoratum roots, wash and slice them, and preliminarily pulverize them to a particle size of 1 - 3 mm. Then, send the materials into a jet milling chamber through a closed feeding system, use nitrogen with a pressure of 0.75 Mpa, and through a supersonic nozzle with a speed ≥ 2.5 Mach to form a high-speed air flow, so that the material particles collide, rub, and shear violently. The pulverized fine powder passes through an internal centrifugal classification wheel with a rotation speed of 5000 r / min, and the coarse particles return to the milling chamber for cyclic treatment, and collect the qualified fine powder; (4) Combine the powders obtained in the above steps (1), (2), and (3), mix them, and prepare them into a powder.

7. Use of the product for regulating gastrointestinal function containing inulin as claimed in claim 1 in the preparation of a product for improving constipation.

8. Use of the inulin-containing gastrointestinal function regulating product according to claim 1 in the preparation of a product for improving constipation, characterized in that, Constipation belongs to the type of heat constipation syndrome.

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