Composition with effects of ventilating, relieving abdominal distension and pain and improving constipation and application thereof

Abstract

The invention provides a composition capable of ventilating, relieving abdominal distension and pain and improving constipation and application, and relates to the technical field of medicines. The composition is prepared from the following components: 30-40 parts of hawthorn, 5-15 parts of malt, 1-5 parts of Chinese yam, 2-10 parts of endothelium corneum gigeriae galli, 5-15 parts of orange peel and 3-10 parts of semen raphani. All the components supplement each other and are indispensable, so that the synergistic effects of ventilating, relieving abdominal distension and pain and improving constipation are achieved. The composition disclosed by the invention has the remarkable effects of ventilating, relieving abdominal distension and pain and improving the gastric emptying rate and the small intestine propulsion rate on postoperative enteroparalysis rats, atropine-induced gastrointestinal dysfunction rats and iodoacetamide intragastric lavage and small platform combined gastrointestinal dysfunction rats; for constipation mice, the traditional Chinese medicine composition has the functions of remarkably reducing the first-grain black defecation time, increasing the defecation grain number and weight, increasing the content of 5-HT and SP in the bodies of the constipation mice, reducing the content of VIP and improving intestines and stomach.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and specifically relates to a composition and application thereof that can ventilate, relieve abdominal distension and pain, and improve constipation. Background Art

[0002] Gastrointestinal health problems often manifest as: flatulence, bloating, constipation, diarrhea, abdominal pain, poor appetite, food accumulation, etc. Studies have shown that long-term gastrointestinal discomfort not only affects the normal function of the digestive system, but may also cause other health problems, such as decreased immunity, sleep disorders, and even mental health. Children are more susceptible to problems such as flatulence and constipation because their gastrointestinal tract and immune system are not yet fully developed, and middle-aged and elderly people have weakened gastrointestinal function due to aging. Young people may also experience the above situation due to irregular diet, high stress, lack of exercise, etc.

[0003] At present, there are many Western medicines for treating gastrointestinal problems, which can relieve symptoms in the short term, but most of them are often accompanied by side effects, such as intestinal flora imbalance, increased drug resistance, etc. In addition, hyperosmotic laxatives such as magnesium sulfate may cause symptoms of electrolyte disorders such as hypermagnesemia. In contrast, traditional Chinese medicine, with its natural ingredients and holistic conditioning concept, provides a gentler and more lasting solution, and is therefore favored by more and more people.

[0004] Chinese invention patent CN113967239A discloses a hawthorn probiotic powder and its preparation process. The technical scheme of the invention is: 18-95 parts of malt, 1-8 parts of chicken gizzard lining, 18-95 parts of Shenqu, 18-95 parts of Poria cocos, 15-85 parts of radish seeds, 12-65 parts of white lentils, 1-10 parts of dried orange peel, 20-100 parts of hawthorn, 4-25 parts of Chinese yam and 14-75 parts of probiotics. The prepared hawthorn probiotic powder is used for spleen and stomach disharmony, indigestion, loss of appetite, constipation, food stagnation, malnutrition and other symptoms, and is used to solve and improve problems such as food accumulation and anorexia in professional groups, middle and high school students and the elderly.

[0005] Chinese invention patent CN114869981A discloses a hawthorn eight-ingredient paste, which is prepared from the main medicine, the auxiliary medicine, and the adjuvant medicine. The main medicine is charred hawthorn, malt, chicken gizzard lining, and radish seed; the auxiliary medicine is tuckahoe and Chinese yam; and the adjuvant medicine is dried orange peel and Amomum villosum. The eight-ingredient paste has the effects of strengthening the spleen and promoting digestion, and improving digestive function. It is particularly suitable for treating symptoms such as food stagnation, abdominal distension, belching, acid regurgitation, and loss of appetite. Chinese invention patent CN117441892A discloses a food with the function of digesting food and relieving stagnation, which is prepared from the following medicinal and edible raw materials in parts by weight: 20-30 parts of hawthorn, 15-25 parts of radish seeds, 18-22 parts of emblica, 12-18 parts of artificially cultivated ginseng, 25-35 parts of yam, 18-22 parts of polygonatum, 15-25 parts of malt, 8-12 parts of chicken's gizzard lining, 20-30 parts of wolfberry, 15-25 parts of sea buckthorn, 18-22 parts of tangerine peel and 10-20 parts of poria. The product of the invention can digest food and relieve stagnation, nourish yin and benefit the stomach, and jointly clear food stagnation.

[0006] Although the traditional Chinese medicine formula in the prior art has certain efficacy in treating gastrointestinal problems, the formula contains many ingredients, and the synergistic effects between the ingredients in the formula are not clear. Therefore, it is necessary to find a more concise formula, a composition with high efficiency in ventilation, relieving abdominal distension and pain, and improving constipation. Summary of the invention

[0007] In view of the problems existing in the prior art, the present invention provides a composition and application having the functions of ventilation, alleviating abdominal distension and pain, and improving constipation.

[0008] In the composition of the present invention, hawthorn is the main medicine, has the effects of digestion and accumulation, promoting qi and dispersing blood stasis, can significantly promote gastrointestinal peristalsis, and relieve abdominal distension and abdominal pain caused by food accumulation stagnation. Malt and hawthorn are in pairs, and are the main medicines, which enhance the power of digestion and stomachic invigoration, and are especially good at dissolving rice, flour, potato and taro stagnation, and have the effect of promoting qi and soothing the liver, which is conducive to the smooth flow of qi. Chinese yam nourishes the spleen and nourishes the stomach, promotes the production of body fluid and benefits the lung, and nourishes the kidney and astringes the essence. In this paste, as one of the ministerial medicines, it not only nourishes the spleen and stomach, enhances the transportation and transformation function, but also can consolidate the intestines, prevent excessive diarrhea, and play the merit of strengthening the spleen and relieving swelling with hawthorn and malt. Chicken's gizzard lining is also a ministerial medicine, and its power of digestion and accumulation is strong, and it is especially good at digesting various dietary stagnation, and can strengthen the spleen and stomach, and is used in combination with hawthorn and malt, which significantly enhances the effect of relieving swelling and relieving pain. Tangerine peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm. As a ministerial drug, its qi-moving power can help hawthorn and malt promote qi and relieve abdominal distension. At the same time, its dampness-removing effect helps improve constipation caused by dampness blocking the middle jiao. Radish seeds can help digestion and dissipate distension, descend qi and resolve phlegm. They are also ministerial drugs. When used with tangerine peel, they can enhance the power of qi-moving and stagnation-removing, and have a significant effect on symptoms such as abdominal distension, abdominal pain, and constipation. The whole formula uses hawthorn and malt as the main ingredients, focusing on digestion and accumulation, qi-moving and pain-relieving; yam, chicken gizzard lining, tangerine peel, and radish seeds are all ministerial drugs, synergistically enhancing the effect, strengthening the spleen and promoting qi, drying dampness and dissipating distension, and improving constipation.

[0009] Terms and Claims of the Present Invention:

[0010] 1. As used herein, the articles "a", "an" and "the" include plural referents unless expressly limited to one or more referents otherwise.

[0011] 2. As used herein, numerical range: Unless otherwise expressly indicated, all ranges or ratios disclosed herein will be understood to include any and all sub-ranges or sub-ratios contained therein. For example, a range or ratio of 1 to 30 stated should be considered to be included between a minimum value of 1 and a maximum value of 30, and any sub-range or sub-ratio, integer, decimal, or sub-range or sub-ratio consisting of integers or decimals including the end points.

[0012] 3. As used herein, the terms "comprises," "including," "have," "have," "may," "contain" and variations thereof mean open-ended conjunctions or terms that do not exclude the possibility of additional compositions or structures.

[0013] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0014] Firstly, the invention provides a composition with the functions of ventilation, relieving abdominal distension and pain, and improving constipation, which is prepared from the following components: hawthorn, malt, yam, chicken gizzard lining, tangerine peel and radish seed.

[0015] Preferably, the composition is made of the following components in parts by weight: 30-40 parts of hawthorn, 5-15 parts of malt, 1-5 parts of yam, 2-10 parts of chicken gizzard lining, 5-15 parts of orange peel and 3-10 parts of radish seeds.

[0016] Further preferably, the composition is made of the following components in parts by weight: 35 parts of hawthorn, 10 parts of malt, 2.6 parts of yam, 5 parts of chicken gizzard lining, 10 parts of tangerine peel and 5 parts of radish seeds.

[0017] Then, the present invention provides a preparation method of the composition, comprising the steps of: mixing hawthorn, malt, yam, chicken gizzard lining, orange peel, radish seed and water, heating and refluxing for extraction, combining the extracts, and drying to obtain an extract.

[0018] Preferably, the heating reflux extraction is performed 1-4 times; further preferably, the heating reflux extraction is performed 2 times.

[0019] Preferably, the solid-liquid ratio of the heating reflux extraction is 1g:5-20mL; further preferably, the solid-liquid ratio of the heating reflux extraction is 1g:10mL.

[0020] Preferably, the heating reflux extraction is performed for 0.5-2 hours each time at an extraction temperature of 90-100°C.

[0021] Further preferably, the heating reflux extraction is performed for 1 hour each time at an extraction temperature of 95-100°C.

[0022] Preferably, the drying is drying at a temperature below 60° C.; more preferably, the drying is freeze-drying.

[0023] Furthermore, the present invention provides a medicine having the functions of ventilation, relieving abdominal distension and pain, and improving constipation, wherein the effective ingredients include the above-mentioned composition, or the extract prepared by the above-mentioned preparation method.

[0024] Finally, the present invention provides the use of the above composition, or the extract prepared by the above preparation method in preparing a product having at least one of the functions of ventilation, relieving abdominal distension and abdominal pain, and improving constipation.

[0025] Preferably, the dosage form of the drug is any oral drug dosage form, not limited to pills, capsules, granules, oral liquids, powders, tablets, lozenges, pastes and other dosage forms. Suitable drug carriers in the art can be selected for different dosage forms.

[0026] Further preferably, the method for preparing the ointment comprises the steps of:

[0027] S1, mixing hawthorn, malt, yam, chicken gizzard lining, orange peel, radish seed with water, heating and refluxing to obtain an extract;

[0028] S2, after the extract is concentrated, it is heated and stirred with the chitosan solution, allowed to stand, and centrifuged to obtain a supernatant;

[0029] S3. The supernatant is concentrated to obtain an ointment.

[0030] More preferably, the method for preparing the ointment comprises the steps of:

[0031] S1, take hawthorn, malt, yam, chicken gizzard lining, orange peel, radish seed and water, mix, heat reflux extraction 1-4 times, obtain extract; the heating reflux extraction, solid-liquid ratio 1g:5-20mL, each extraction 0.5-2h, extraction temperature 90-100 ℃;

[0032] S2. After the extract is concentrated to a specific gravity of 1:1-1.2, it is heated and stirred with the chitosan solution at 50-70°C for 20-50 minutes, allowed to stand for 8-16 hours, and centrifuged to obtain a supernatant;

[0033] The chitosan solution is prepared by mixing and dissolving chitosan with a concentration of 0.3-0.8% of the medicinal material and an acetic acid aqueous solution with a concentration of 0.5-2% by volume; the mass volume ratio of chitosan to the acetic acid aqueous solution is 1 g: 60-80 mL;

[0034] S3. The supernatant is concentrated to a specific gravity of 1.28-1.31 (60-70° C.) to obtain a paste.

[0035] More preferably, the method for preparing the ointment comprises the steps of:

[0036] S1. Mix hawthorn, malt, yam, chicken gizzard lining, orange peel, radish seed and water, and heat and reflux extract twice to obtain an extract; the heating and reflux extraction has a solid-liquid ratio of 1g:10mL, each extraction is 1h, and the extraction temperature is 95-100°C;

[0037] S2, after the extract is concentrated to a specific gravity of 1:1, it is heated and stirred with the chitosan solution at 60°C for 30 minutes, allowed to stand for 12 hours, and centrifuged to obtain the supernatant;

[0038] The chitosan solution is prepared by mixing and dissolving chitosan with a concentration of 0.5% of the medicinal material and an acetic acid aqueous solution with a volume concentration of 1%; the mass volume ratio of the chitosan to the acetic acid aqueous solution is 1 g:70 mL;

[0039] S3. The supernatant is concentrated to a specific gravity of 1.28-1.31 (60-70° C.) to obtain a paste.

[0040] The pharmaceutical carrier used can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0041] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are the preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0042] Tablets containing the Chinese medicine composition or extract of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be tableted in a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with a binder, a lubricant, an inert diluent, a surfactant or a dispersant to prepare a tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0043] The pharmaceutical composition suitable for parenteral administration of the present invention can be prepared as an aqueous solution or suspension of the active compound. Suitable surfactants such as hydroxypropylcellulose can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0044] Medicine of the present invention can be in the form suitable for topical use, for example aerosol, cream, ointment, lotion, powder or the like. In addition, composition can be in the form suitable for transdermal administration device. Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method. For example, by mixing hydrophilic material and water, and about 5wt% to about 10wt% of compound, prepare cream or ointment with required consistency.

[0045] The medicine of the present invention can be in a form suitable for rectal administration, wherein the carrier is a solid. Preferably, the mixture is made into a unit dose suppository. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0046] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, adhesives, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0047] Compared with the prior art, the present invention has the following beneficial effects:

[0048] The invention combines hawthorn, malt, yam, chicken gizzard lining, orange peel and radish seed in a specific ratio, and the components complement each other and are indispensable, and work together to bring synergistic effects of ventilation, relieving abdominal distension and abdominal pain, and improving constipation.

[0049] The composition of the present invention has significant effects on ventilation, relieving abdominal distension and pain, and improving gastric emptying rate and small intestinal propulsion rate in rats with postoperative intestinal paralysis, rats with gastrointestinal dysfunction induced by atropine, and rats with gastrointestinal dysfunction induced by intragastric administration of iodoacetamide combined with the small platform method. The composition of the present invention has significant effects on reducing the time of the first black stool, increasing the number and weight of stool particles, increasing the content of 5-HT and SP in constipated mice, and reducing the content of VIP, thereby improving the gastrointestinal function of mice. DETAILED DESCRIPTION

[0050] The following non-limiting examples can make those of ordinary skill in the art understand the present invention more comprehensively, but do not limit the present invention in any way. The following content is merely an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the present invention according to the disclosed content, and it should also belong to the scope of the present invention. When the embodiment gives a numerical range, it should be understood that, unless otherwise specified in the present invention, the two endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those of ordinary skill in the technical field to which the present invention belongs.

[0051] The present invention is further described below by way of specific examples. Unless otherwise specified, the various chemical reagents used in the examples of the present invention are obtained through conventional commercial channels.

[0052] Example 1

[0053] A composition having the functions of ventilating, relieving abdominal distension and pain, and improving constipation, comprising the following components by weight: 35 parts of hawthorn, 10 parts of malt, 2.6 parts of yam, 5 parts of chicken gizzard lining, 10 parts of orange peel, and 5 parts of radish seeds.

[0054] The preparation method of the composition is:

[0055] Mix hawthorn, malt, yam, chicken gizzard lining, orange peel, radish seed and water, and heat and reflux for extraction twice to obtain an extract; concentrate the extract, and freeze-dry to obtain a composition;

[0056] The heating reflux extraction has a solid-liquid ratio of 1g:10mL, each extraction lasts 1h, and the extraction temperature is 95-100°C.

[0057] Example 2

[0058] A composition having the functions of ventilating, relieving abdominal distension and pain, and improving constipation, comprising the following components by weight: 30 parts of hawthorn, 15 parts of malt, 1 part of yam, 10 parts of chicken gizzard lining, 15 parts of orange peel, and 3 parts of radish seeds.

[0059] The preparation method of the composition is the same as that of Example 1.

[0060] Example 3

[0061] A composition having the functions of ventilating, relieving abdominal distension and pain, and improving constipation, comprising the following components by weight: 40 parts of hawthorn, 5 parts of malt, 5 parts of yam, 2 parts of chicken gizzard lining, 2 parts of orange peel, and 10 parts of radish seeds.

[0062] The preparation method of the composition is the same as that of Example 1.

[0063] Comparative Example 1

[0064] The composition comprises the following components by weight: 20 parts of hawthorn, 20 parts of malt, 6 parts of yam, 1 part of chicken gizzard lining, 4 parts of tangerine peel and 15 parts of radish seeds.

[0065] The preparation method of the composition is the same as that of Example 1.

[0066] Comparative Example 2

[0067] The composition comprises the following components by weight: 45 parts of hawthorn, 3 parts of malt, 0.5 parts of yam, 12 parts of chicken gizzard lining, 20 parts of orange peel and 2 parts of radish seeds.

[0068] The preparation method of the composition is the same as that of Example 1.

[0069] Comparative Example 3

[0070] The composition comprises the following components by weight: 35 parts of hawthorn, 10 parts of malt, 2.6 parts of yam, 5 parts of chicken gizzard lining and 10 parts of orange peel.

[0071] The preparation method of the comparative example composition is:

[0072] Hawthorn, malt, Chinese yam, chicken gizzard lining, orange peel and water are mixed, and the mixture is subjected to heating and reflux extraction twice to obtain an extract; the extract is concentrated and freeze-dried to obtain a composition;

[0073] The heating reflux extraction has a solid-liquid ratio of 1g:10mL, each extraction lasts 1h, and the extraction temperature is 95-100°C.

[0074] Comparative Example 4

[0075] The composition comprises the following components by weight: 35 parts of hawthorn, 10 parts of malt, 5 parts of chicken gizzard lining and 5 parts of radish seeds.

[0076] The preparation method of the comparative example composition is:

[0077] Mix hawthorn, malt, chicken gizzard lining, radish seeds and water, heat and reflux for extraction twice to obtain an extract; concentrate the extract, and freeze-dry to obtain a composition;

[0078] The heating reflux extraction has a solid-liquid ratio of 1g:10mL, each extraction lasts 1h, and the extraction temperature is 95-100°C.

[0079] Comparative Example 5

[0080] The composition comprises 35 parts of hawthorn, 10 parts of malt, 10 parts of orange peel and 5 parts of radish seeds in parts by weight. The rest is the same as that in Example 1.

[0081] The preparation method of the comparative example composition is:

[0082] Hawthorn, malt, orange peel, radish seed and water are mixed, and the mixture is subjected to heating and reflux extraction twice to obtain an extract; the extract is concentrated and freeze-dried to obtain a composition;

[0083] The heating reflux extraction has a solid-liquid ratio of 1g:10mL, each extraction lasts 1h, and the extraction temperature is 95-100°C.

[0084] Comparative Example 6

[0085] The composition was prepared according to the raw materials described in Example 2 of Chinese invention patent CN114869981A.

[0086] The composition comprises the following components by weight: 6 parts of hawthorn, 9 parts of malt, 6 parts of chicken's gizzard lining, 6 parts of radish seeds, 9 parts of tuckahoe, 9 parts of yam, 6 parts of tangerine peel and 3 parts of amomum villosum.

[0087] The preparation method of the comparative example composition is:

[0088] Mix hawthorn, malt, chicken gizzard lining, radish seed, poria, yam, dried orange peel, amomum villosum and water, and heat and reflux for extraction twice to obtain an extract; concentrate the extract, and freeze-dry to obtain a composition;

[0089] The heating reflux extraction has a solid-liquid ratio of 1g:10mL, each extraction lasts 1h, and the extraction temperature is 95-100°C.

[0090] Trial 1: Improvement of abdominal bloating and gas

[0091] 1. Experimental animals: 130 SPF healthy male SD rats (6-8 weeks old, body weight 160-200 g, purchased from Jiangsu Jicui Yaokang Biotechnology Co., Ltd., experimental animal production license number: SCXK (Su) 2023-0009) were adaptively raised for 1 week under the conditions of room temperature 25 ° C, humidity 60%, and 12 h light and dark cycle.

[0092] Before the experiment, rats were randomly divided into 13 groups, 10 rats in each group, and the groups were set as: sham operation group, model control group, Magnolia bark exhaust mixture group, low-dose group of Example 1, high-dose group of Example 1, Example 2 group, Example 3 group, comparative example group 1, comparative example group 2, comparative example group 3, comparative example group 4, comparative example group 5, and comparative example group 6.

[0093] 2. Dosage and dosage

[0094] (1) Sham operation group: normal saline.

[0095] (2) Model control group: normal saline.

[0096] (3) Magnolia officinalis mixture (positive control): Magnolia officinalis mixture was purchased from Ruiyang Pharmaceutical Co., Ltd., approval number: National Medicine Standard Z20050563; drug specifications: 100 mL / bottle; dosage: 8.94 mL / kg.

[0097] (4) Example 1 low dose group: dosage 0.6 g·kg -1 , dissolved in saline.

[0098] (5) Example 1 High-dose group: dosage 1.2 g·kg -1 , dissolved in saline.

[0099] (6) Example 2 group, Example 3 group, Comparative Example 1 to Comparative Example 6 group: dosage 1.2 g·kg -1 All animals were given an equal amount of normal feed + drinking water, and the above dose was administered once by gavage 3 hours after surgery.

[0100] 3. Test methods and indicators

[0101] A postoperative intestinal paralysis model was prepared. The rats in the model control group fasted for 12 hours before surgery, and the rats in the other groups were anesthetized by intraperitoneal injection of 1% sodium pentobarbital according to their body weight. After surgical skin preparation, the abdomen of the rats was first routinely disinfected, and sterile gauze was quickly laid after incision to protect the surgical area. A vertical incision of about 2 cm was made in the midline of the abdomen, and the small intestine of the rats in the model control group and each drug-treated group was placed on gauze containing saline. A slightly damp cotton swab soaked in saline was used to gently rub the small intestine, and the operation of rubbing back and forth from the proximal jejunum to the terminal ileum and then from the terminal ileum to the proximal jejunum was completed 3 times within 5 minutes, and it was appropriate to control the small intestine to have moderate congestion and edema. After the rat intestinal operation was completed, the small intestine was gently returned to the abdominal cavity. Subsequently, 5-0 surgical sutures were used to suture the abdominal muscle layer and cortical wounds respectively, and the wound was disinfected again after the suture to prevent infection. For the rats in the sham operation group, an incision of about 2 cm was made in the abdomen and the rats were left to rest for 6 min, during which the small intestine was not removed for swabbing.

[0102] 3.1 Gastric volume measurement

[0103] The rats were killed 24 hours after surgery, and the front and back ends of the stomach were tied with string and placed in a 50 mL centrifuge tube containing a fixed volume of water. The height of the water surface was observed and the volume change was recorded, which was the stomach volume. The experiment should be performed by the same person under the same conditions (time, location, lighting brightness, humidity and temperature).

[0104] 3.2 Determination of small intestinal propulsion rate

[0105] Each group of rats was gavaged with dextran blue-2000 (20 g / L) 30 minutes before being killed, 1.5 mL / rat. After being killed, the small intestine was laid flat on a cardboard and naturally straightened. The distance from the pyloric sphincter to the ileocecal part (M), the distance from the pyloric sphincter to the front end of the pigment (m), and the small intestine propulsion rate (%) = m / M × 100%. The experiment should be performed by the same person under the same conditions (time, location, lighting brightness, humidity and temperature).

[0106] 4. Test results

[0107] As shown in Table 1 , compared with the sham operation group, the gastric volume of the model control group increased and the intestinal propulsion rate decreased (P<0.001), indicating that the postoperative intestinal paralysis model was successfully established.

[0108] 4.1 Effect on gastric volume

[0109] As shown in Table 1, compared with the model control group, the low-dose group of Example 1 and the comparative examples 1-5 showed a decreasing trend but no significance. The Houpo Qi Expelling Mixture group, the high-dose group of Example 1, the Example 2-3 group, and the comparative example 6 group showed more significant therapeutic effects compared with the model control group (P<0.01, P<0.001). Compared with the high-dose group of Example 1, there was no significant difference in the Example 2-3 group and the comparative example 6 group, and there was a significant difference in the comparative example 1-5 group (P<0.05, P<0.01, P<0.001), indicating that the drug combination of the embodiment has the best effect, and the ratio should be within a specific range. The effect of the high-dose group of Example 1 and the comparative example 6 group is not much different, indicating that the efficacy of the present invention is not reduced after the drug taste is simplified compared with the comparative example 6. The above results show that the high-dose group of Example 1 and the Example 2-3 group can significantly reduce the stomach volume of mice with postoperative intestinal paralysis and improve the gastrointestinal function of mice.

[0110] 4.2 Effects on small intestinal propulsion

[0111] As shown in Table 1, compared with the sham operation group, the average small intestinal propulsion rate of the model control group was only 22.5%, which was significantly different. The average small intestinal propulsion rates of the Houpo Qi-exhausting mixture group, the high-dose group of Example 1, the groups of Examples 2-3, and the comparative example 6 were 71.23%, 72.38%, 69.32%, 68.69%, and 70.15%, respectively. It can be seen that compared with the model control group, the high-dose group of Example 1 can significantly enhance the small intestinal propulsion rate (P<0.001), and the effect is equivalent to that of the positive drug group. Compared with the low-dose group of Example 1, the high-dose group of Example 1, the groups of Examples 2-3, and the comparative example 6 showed significant differences (P<0.01, P<0.001). Compared with the high-dose group of Example 1, there were no significant differences in the groups of Examples 2-3 and the comparative example 6, and there were significant differences in the comparative example 1-5 groups (P<0.05, P<0.01), indicating that the drug combination of the embodiment has the best effect, and the ratio should be within a specific range. The effects of the high-dose group of Example 1 and the comparative example 6 group were similar, indicating that the efficacy of this formula was not reduced after the medicine flavor was simplified compared with the comparative example 6. The above results show that the high-dose group of Example 1 and Examples 2-3 can significantly increase the small intestinal propulsion rate of postoperative intestinal paralysis mice and improve the gastrointestinal function of mice.

[0112] Table 1 Changes in gastric volume and small intestinal propulsion rate of rats 24 hours after surgery ( n=10)

[0113] Group Stomach volume (mL) Small intestinal propulsion rate (%) Sham operation group <![CDATA[3.22±0.55 *** ]]> <![CDATA[77.40±4.57 *** ]]> Model control group 11.61±1.34 22.50±1.38 Houpo Qifa Mixture Group <![CDATA[8.31±2.09 *** ]]> <![CDATA[71.23±5.28 *** ]]> Example 1 Low dose group <![CDATA[11.47±1.24 ### ]]> <![CDATA[26.83±8.03 ### ]]> Example 1 High dose group <![CDATA[8.25±1.43 ***◆◆◆ ]]> <![CDATA[72.38±4.40 ***◆◆ ]]> Example 2 Group <![CDATA[8.07±1.87 **◆◆◆ ]]> <![CDATA[69.32±4.14 **◆◆ ]]> Example 3 Group <![CDATA[8.21±1.90 **◆◆◆ ]]> <![CDATA[68.69±5.13 **◆◆ ]]> Comparative Example 1 <![CDATA[9.97±2.22 # ]]> <![CDATA[28.64±10.98 ## ]]> Comparative Example 2 <![CDATA[10.06±2.20 # ]]> <![CDATA[26.81±6.09 ## ]]> Comparative Example 3 <![CDATA[11.00±1.55 ### ]]> <![CDATA[27.13±6.95 ## ]]> Comparative Example 4 <![CDATA[11.01±1.57 ### ]]> <![CDATA[27.06±7.71 ## ]]> Comparative Example 5 <![CDATA[10.83±1.54 ### ]]> <![CDATA[29.30±11.79 # ]]> Comparative Example 6 <![CDATA[8.29±2.35 ***◆◆◆ ]]> <![CDATA[70.15±3.15 ***◆◆ ]]>

[0114] Compared with the model control group, * P<0.05, ** P<0.01, *** P < 0.001;

[0115] Compared with the low-dose group in Example 1, ◆ P<0.05, ◆◆ P<0.01, ◆◆◆ P < 0.001;

[0116] Compared with the high-dose group in Example 1, # P<0.05, ## P<0.01, ### P<0.001.

[0117] Trial 2: Relieve abdominal bloating and pain

[0118] 1. Experimental animals: Two batches of SPF-grade healthy male SD rats, one batch of SD rats (6-8 weeks old, 130 rats, body weight 180-200g), and one batch of SD rat suckling mice (10 days old, 130 rats). All animals were purchased from Jiangsu Jicui Yaokang Biotechnology Co., Ltd., with the experimental animal production license number: SCXK (Su) 2023-0009. Each batch of experimental animals was randomly divided into 13 groups, and the groups were set as: normal control group, model control group, Baohe pill group, Example 1 low-dose group, Example 1 high-dose group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group, Comparative Example 6 group.

[0119] Among them, SD rats were used to carry out atropine-induced gastrointestinal dysfunction experiments, and SD rat neonates were used to carry out gastrointestinal dysfunction experiments induced by iodoacetamide gavage combined with the small platform method.

[0120] 2. Dosage and dosage

[0121] (1) Normal control group: normal saline.

[0122] (2) Model control group: normal saline.

[0123] (3) Baohe Pills group (positive control): purchased from Shanxi Huakang Pharmaceutical Co., Ltd., approval number: National Medicine Standard Z14020086; drug specification: 9 g × 10 pills / box; dosage: 4.6 g kg -1 ·d -1 , dissolved in saline.

[0124] (4) Example 1 low dose group: dosage 0.6 g·kg -1 , dissolved in saline.

[0125] (5) Example 1 High-dose group: dosage 1.2 g·kg -1 , dissolved in saline.

[0126] (6) Example 2 group, Example 3 group, Comparative Example 1 to Comparative Example 6 group: dosage 1.2 g·kg -1 , dissolved in saline. Atropine-induced gastrointestinal dysfunction experiment: The normal control group and the model control group were gavaged with 0.9% saline, and the gavage doses of the other groups of rats were given according to the above doses. The drug was administered once a day for 5 consecutive days. After the last dose, all mice were fasted but not watered. At the same time, 1 hour after the last dose, the blank control group was intraperitoneally injected with an equal volume of saline, and the other test groups were intraperitoneally injected with 1 mg / kg of atropine sulfate. 20 minutes later, 3 mL of nutritious semisolid paste was gavaged, and then the gastric emptying rate and small intestinal propulsion rate were measured. The animals were killed 20 minutes later, and the gastric cardia and pylorus were quickly dissected and ligated.

[0127] Gastrointestinal dysfunction experiment induced by intragastric administration of iodoacetamide combined with the small platform method: Except for the normal control group, all other groups were administered distilled water (1mL / 100g) by intragastric administration once a day in the morning according to the above dosage. The drug intervention started after the completion of standing on the small platform, that is, on the 56th day after birth, and the medication was continued for 14 days according to the above dosage for each group.

[0128] 3. Test methods and indicators

[0129] For the atropine-induced gastrointestinal dysfunction experimental group, 1 mg / kg atropine sulfate was intraperitoneally injected into the rats once 40 minutes before the animals were killed to construct a temporary rat gastrointestinal dysfunction model.

[0130] For the experimental group of gastrointestinal dysfunction induced by oral administration of iodoacetamide combined with the small platform method, after 3 days of animal adaptive feeding, each rat was given 2% sucrose solution (0.2 mL / day) for 6 days; each rat in the model group was given a mixture of 1% iodoacetamide and 2% sucrose (0.2 mL / day) for 6 days. On the 22nd day after birth, the pups in each group were separated from the mothers, with 5 rats in each cage, and fed with complete pellet feed. On the 43rd day after birth, except for the normal control group, all other groups were treated with the modified small platform method (water was poured into the water tank of the small platform standing box, and the water temperature was controlled at (22±2)℃. The amount of water poured should be such that the water surface reached 2.0cm below the small platform surface. Rats can move freely on the small platform. Once they fall asleep, they will fall into the water due to muscle relaxation and cannot rest, thus causing fatigue in the rats. The small platform standing was performed from 17:00 to 7:00 the next day for 14 hours every day for 14 consecutive days to construct a persistent rat gastrointestinal dysfunction model.

[0131] 3.1 Gastric emptying rate measurement

[0132] After 24 hours of fasting without water, 10g of sodium carboxymethyl cellulose was taken from each group of rats, dissolved in 250mL of distilled water, and 16g of milk powder, 8g of sugar, 8g of starch and 2g of activated carbon powder were added respectively, stirred evenly, and prepared into 300mL of about 300g of black semi-solid paste. Each rat was fixedly gavaged with 3mL. After 50 minutes, 7% chloral hydrate was anesthetized, the abdominal cavity was quickly opened, the cardia and pylorus were ligated, the whole stomach was removed, and the whole stomach weight (g) was weighed after being wiped dry with filter paper. After that, the stomach body was cut open along the greater curvature of the stomach, the stomach contents were washed and wiped dry, and the net weight of the stomach (g) was weighed, and the gastric emptying rate was calculated according to the following formula:

[0133] Gastric emptying rate (%) = [1-(total stomach weight-net stomach weight) / oral gavage weight] × 100%;

[0134] The experiment should be carried out by the same person under the same conditions (time, location, lighting brightness, humidity and temperature).

[0135] 3.2 Determination of small intestinal propulsion rate

[0136] Open the rat's abdominal cavity, separate the mesentery, cut the intestinal tube from the pylorus to the ileocecal part, and lay it flat on a glass plate without traction. Measure the distance from the pylorus to the front of the carbon powder (the distance the front end of the carbon powder advances, cm), and record the total length of the small intestine (cm). The percentage of the ratio is the advancement percentage. Calculate the small intestine advancement rate according to the following formula:

[0137] Small intestine advancement rate (%) = (distance advanced by the front end of the carbon powder / total length of the small intestine) × 100%.

[0138] The experiment should be carried out by the same person under the same conditions (time, location, lighting brightness, humidity and temperature).

[0139] 4. Test results

[0140] 4.1 Effects on gastrointestinal motility in rats with atropine-induced gastrointestinal dysfunction

[0141] As shown in Table 2, compared with the normal control group, the gastric emptying rate and intestinal propulsion rate of the model control group were reduced (P<0.001), indicating that the model of atropine-induced gastrointestinal dysfunction was successfully established.

[0142] 4.1.1 Effects on gastric emptying rate in rats with atropine-induced gastrointestinal dysfunction

[0143] As shown in Table 2, compared with the model control group, the low-dose group of Example 1 and the comparative examples 1-5 have an improvement trend but no significance. The Baohe Pills group, the high-dose group of Example 1, the groups of Examples 2-3 and 6, showed a more significant therapeutic effect (P<0.001) compared with the model control group, and the high-dose group of Example 1 was equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there was no significant difference between the groups of Examples 2-3 and 6, and there was a significant difference between the groups of Comparative Examples 1-5 (P<0.01, P<0.001). The drug combination of the embodiment had the best effect, and the ratio should be within a specific range. The effects of the high-dose group of Example 1 and the comparative example 6 group were not much different, suggesting that the present invention's prescription was not reduced after the drug taste was simplified relative to the comparative example 6. The above results show that the high-dose group of Example 1, the groups of Examples 2-3 and the comparative example 6 can significantly enhance the gastric emptying rate of rats with gastrointestinal dysfunction caused by atropine and improve the gastrointestinal function of rats.

[0144] 4.1.2 Effects on small intestinal propulsion rate in rats with atropine-induced gastrointestinal dysfunction

[0145] As shown in Table 2, compared with the model control group, the low-dose group of Example 1 and the comparative examples 1-5 have an improvement trend but no significance. The Baohe Pills group, the high-dose group of Example 1, the groups of Examples 2-3 and 6, showed more significant efficacy compared with the model control group (P<0.01, P<0.001), and the high-dose group of Example 1 was equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there was no significant difference in the groups of Examples 2-3 and 6, and there was a significant difference in the groups of Comparative Examples 1-5 (P<0.01, P<0.001), indicating that the drug combination of the embodiment has the best effect, and the ratio should be within a specific range. The effects of the high-dose group of Example 1 and the comparative example 6 group are not much different, indicating that the present invention is relatively comparative example 6, and the efficacy is not reduced after the drug taste is simplified. The above results show that the high-dose group of Example 1, the groups of Examples 2-3 and 6, can significantly enhance the small intestinal propulsion rate of rats with gastrointestinal dysfunction caused by atropine, and improve the gastrointestinal function of rats.

[0146] Table 2 Results of gastric emptying rate and small intestinal propulsion rate in rats with gastrointestinal dysfunction induced by atropine ( n=10)

[0147] Group Gastric emptying rate (%) Small intestinal propulsion rate (%) Normal control group <![CDATA[59.5±9.42 *** ]]> <![CDATA[66.52±6.56 *** ]]> Model control group 40.42±5.68 36.52±5.61 Bohe pill group <![CDATA[59.3±5.89 *** ]]> <![CDATA[59.14±6.17 ** ]]> Example 1 Low dose group <![CDATA[43.7±5.17 ### ]]> <![CDATA[40.15±10.03 ### ]]> Example 1 High dose group <![CDATA[59.64±8.29 ***◆◆ ]]> <![CDATA[60.17±8.01 **◆◆ ]]> Example 2 Group <![CDATA[57.14±7.45 **◆ ]]> <![CDATA[60.93±7.44 **◆◆ ]]> Example 3 Group <![CDATA[55.62±4.43 **◆ ]]> <![CDATA[59.64±6.68 **◆◆ ]]> Comparative Example 1 <![CDATA[46.88±9.64 # ]]> <![CDATA[44.9±12.12 # ]]> Comparative Example 2 <![CDATA[45.64±7.41 ## ]]> <![CDATA[43.3±10.17 # ]]> Comparative Example 3 <![CDATA[42.22±8.70 ## ]]> <![CDATA[41.6±13.72 ## ]]> Comparative Example 4 <![CDATA[43.88±9.64 ## ]]> <![CDATA[42.38±12.52 ## ]]> Comparative Example 5 <![CDATA[41.88±6.97 ## ]]> <![CDATA[40.8±9.22 ## ]]> Comparative Example 6 <![CDATA[58.15±6.14 ***◆◆ ]]> <![CDATA[60.02±5.24 **◆◆ ]]>

[0148] Compared with the model control group, * P<0.05, ** P<0.01, *** P < 0.001;

[0149] Compared with the low-dose group in Example 1, ◆ P<0.05,◆◆ P<0.01, ◆◆◆ P < 0.001;

[0150] Compared with the high-dose group in Example 1, # P<0.05, ## P<0.01, ### P<0.001.

[0151] 4.2 Effects on gastrointestinal motility in rats with gastrointestinal dysfunction induced by intragastric administration of iodoacetamide combined with the small platform method

[0152] As shown in Table 3, compared with the normal control group, the gastric emptying rate and intestinal propulsion rate of the model control group were decreased (P<0.001), indicating that the establishment of the iodoacetamide-induced gastrointestinal motility disorder model was successful.

[0153] 4.2.1 Effects on gastric emptying rate in rats with gastrointestinal dysfunction induced by intragastric administration of iodoacetamide combined with the small platform method

[0154] As shown in Table 3, compared with the model control group, the low-dose group of Example 1 and the comparative examples 1-5 have an improvement trend but no significance. The Baohe Pills group, the high-dose group of Example 1, the Example 2-3 group, and the comparative example 6 group also showed more significant efficacy compared with the model control group (P<0.01, P<0.001), and the high-dose group of Example 1 was equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there was no significant difference in the Example 2-3 group and the comparative example 6 group, and there was a significant difference in the comparative example 1-5 group (P<0.001). The drug combination of the embodiment had the best effect, and the ratio should be within a specific range. The effect of the high-dose group of Example 1 and the comparative example 6 group was not much different, suggesting that the present invention's prescription was not reduced after the drug taste was simplified relative to the comparative example 6. The above results show that the high-dose group of Example 1, the Example 2-3 group and the comparative example 6 group can significantly enhance the gastric emptying rate of rats with gastrointestinal dysfunction induced by iodoacetamide gavage combined with the small platform method, and improve the gastrointestinal function of rats.

[0155] 4.2.2 Effect of intragastric administration of iodoacetamide combined with small platform method on small intestinal propulsion rate in gastrointestinal dysfunction induced by

[0156] As shown in Table 3, compared with the model control group, the low-dose group of Example 1 and the comparative examples 1-5 have an increasing trend but no significance. The Baohe Pills group, the high-dose group of Example 1, the groups of Examples 2-3 and 6 also showed more significant efficacy (P<0.001) compared with the model control group, and the high-dose group of Example 1 was equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there was no significant difference in the groups of Examples 2-3 and 6, and there was a significant difference in the groups of Comparative Examples 1-5 (P<0.01, P<0.001), indicating that the drug combination of the embodiment has the best effect, and the ratio should be within a specific range. The effects of the high-dose group of Example 1 and the comparative example 6 group are not much different, indicating that the efficacy of this prescription is not reduced after the drug taste is simplified relative to the comparative example 6. The above results show that the high-dose group of Example 1, the groups of Examples 2-3 and 6 can significantly enhance the small intestinal propulsion rate of rats with gastrointestinal dysfunction induced by iodoacetamide gavage combined with the small platform method, and improve the gastrointestinal function of rats.

[0157] Table 3 Results of gastric emptying rate and small intestinal propulsion rate in rats with gastrointestinal dysfunction induced by intragastric administration of iodoacetamide combined with the small platform method ( n=10)

[0158]

[0159]

[0160] In Table 3, compared with the model control group, * P<0.05, ** P<0.01, *** P < 0.001;

[0161] Compared with the low-dose group in Example 1, ◆ P<0.05, ◆◆ P<0.01, ◆◆◆ P < 0.001;

[0162] Compared with the high-dose group in Example 1, # P<0.05, ## P<0.01, ### P<0.001.

[0163] Test 3 Constipation

[0164] 1. Experimental animals: 130 SPF-grade C57BL / 6J mice (2 months old, weighing 25g, half male and half female, purchased from Jiangsu Jicui Yaokang Biotechnology Co., Ltd., experimental animal production license number: SCXK (Su) 2023-0009, fed in an environment with 12h alternation of day and night and room temperature of 24±2°C), were randomly divided into 13 groups after 1 week of adaptive feeding. They are: normal control group, model control group, positive drug group (lactulose oral liquid group), low-dose group of Example 1, high-dose group of Example 1, Example 2 group, Example 3 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, comparative example 5 group, comparative example 6 group. All mice were given the same amount of water and food.

[0165] 2. Administration and dosage

[0166] (1) Normal control group: normal saline.

[0167] (2) Model control group: normal saline.

[0168] (3) Lactulose oral solution group (positive control): purchased from Dalian Meiluo Chinese Medicine Factory Co., Ltd., approval number: National Medicine Standard H20093299; drug specifications: 10 mL × 9 tubes / box (each tube contains 5 g of lactulose); dosage: 0.5 g·kg -1 ·d -1 (equivalent to 1mL / kg of original drug -1 ·d -1 ).

[0169] (4) Example 1 low dose group: dosage 0.6 g·kg -1 , dissolved in saline.

[0170] (5) Example 1 High-dose group: dosage 1.2 g·kg -1 , dissolved in saline.

[0171] (6) Example 2 group, Example 3 group, Comparative Example 1 to Comparative Example 6 group: dosage 1.2 g·kg -1 All animals were given an equal amount of normal feed + drinking water. After one week of adaptive feeding, mice in each group were gavaged once a day for 7 consecutive days according to the above daily dosage, with a gavage volume of 10 mL kg -1 ·d -1 .

[0172] 3. Test methods and indicators

[0173] After the administration, mice in each group were fasted for 16 hours without water restriction to establish constipation model. The model group and each administration group were gavaged with 4 mg / kg loperamide hydrochloride every day to establish constipation model. The normal control group was gavaged with 0.1 mL of sterile water every day for 7 days. After the model was established on the 14th day, all mice were fasted overnight without water restriction.

[0174] 3.1 Determination of the time of first black stool

[0175] After the administration, the blank control group was gavaged with 0.2 mL of 0.9% sodium chloride solution. One hour later, all mice were gavaged with 0.2 mL of 5% carbon powder suspension ink (5 g activated carbon + 1 g sodium carboxymethyl cellulose + 100 mL water), and then placed individually in clean cages to start timing. The end time is the discharge of the first black stool, and the time of the first black stool is the interval between the two times. Record the time of the first black stool of each animal, the number of stools and the weight within 5 hours. The experiment should be performed by the same person under the same conditions (time, location, lighting brightness, humidity and temperature).

[0176] 3.2 Determination of 5-HT, SP, and VIP Contents

[0177] After killing the mice, 1-2 cm of colon was obtained, washed with 0.9% sodium chloride solution, added with pre-cooled 0.9% sodium chloride solution, ground to prepare 10% tissue homogenate, centrifuged at 4000 r / min for 20 min, the supernatant was obtained, and stored at -20°C. The contents of 5-HT, SP and VIP in the colon tissue homogenate were determined according to the instructions of the corresponding ELISA kit.

[0178] 4. Test results

[0179] 4.1 Effects on defecation in mice

[0180] As shown in Table 4, compared with the normal control group, the time to the first black stool of the mice in the model control group was significantly prolonged (P<0.001), and the number and weight of black stool within 5 hours were significantly reduced (P<0.001), indicating that the model was successfully established and the gastrointestinal motility of constipated mice was slower.

[0181] In terms of the time of first black stool, compared with the model control group, the low-dose group of Example 1 and the comparative examples 1-5 have a decreasing trend but no significance. The lactulose oral liquid group, the high-dose group of Example 1, the groups of Examples 2-3 and 6 can significantly shorten the time of first black stool compared with the model control group (P<0.001), and the high-dose group of Example 1 is equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there is no significant difference between the groups of Examples 2-3 and 6, and there is a significant difference between the groups of Comparative Examples 1-5 (P<0.001), indicating that the drug combination of the embodiment is the best, and the ratio should be within a specific range. The effects of the high-dose group of Example 1 and the comparative example 6 group are not much different, indicating that the efficacy of the present invention is not reduced after the drug taste is simplified relative to the comparative example 6.

[0182] In terms of the number and weight of black stool particles within 5 hours, compared with the model control group, the low-dose group of Example 1 and the comparative example 1-comparative example 5 groups have an increasing trend but no significance. The lactulose oral liquid group, the high-dose group of Example 1, the groups of Example 2-Example 3, and the comparative example 6 groups can all significantly improve the number and weight of black stool particles within 5 hours compared with the model control group (P<0.001), and the high-dose group of Example 1 is equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there are no significant differences in the groups of Example 2-Example 3 and the comparative example 6 groups, and there are significant differences in the groups of Comparative Example 1-Comparative Example 5 (P<0.01, P<0.001), indicating that the drug combination of the embodiment is the best, and the ratio should be within a specific range. The effect of the high-dose group of Example 1 and the comparative example 6 groups is not much different, indicating that the present invention's prescription is relatively comparative example 6, and the drug effect is not reduced after the drug taste is simplified.

[0183] The above results show that the high-dose group of Example 1, the groups of Examples 2-3, and the comparative example 6 can significantly enhance the defecation speed and weight of constipated mice and improve the gastrointestinal function of mice, and the effect is equivalent to that of the positive drug group.

[0184] Table 4 The first black stool, the number of black stools within 5 hours, and the weight of black stools within 5 hours in each group of mice n=10)

[0185]

[0186]

[0187] In Table 4, compared with the model control group, * P<0.05, ** P<0.01, *** P < 0.001;

[0188] Compared with the low-dose group in Example 1, ◆ P<0.05, ◆◆ P<0.01,◆◆◆ P < 0.001;

[0189] Compared with the high-dose group in Example 1, # P<0.05, ## P<0.01, ### P<0.001.

[0190] 4.2 Effects on 5-HT, VIP, and SP Contents in Mouse Colon Tissue

[0191] As shown in Table 5, compared with the normal control group, the 5-HT and SP contents of the mice in the model control group were significantly reduced (P<0.001), and the VIP content was significantly increased (P<0.001). Compared with the model group, the low-dose group of Example 1 and the comparative examples 1-5 groups had a trend of increasing 5-HT and SP contents and reducing VIP contents, but there was no significant difference. The lactulose oral liquid group, the high-dose group of Example 1, the groups of Examples 2-3 and 6, compared with the model control group, were all able to significantly increase 5-HT and SP contents, and reduce VIP contents (P<0.05, P<0.01, P<0.001), and the high-dose group of Example 1 was equivalent to the positive drug effect. Compared with the high-dose group of Example 1, there was no significant difference in the groups of Examples 2-3 and 6, and there was a significant difference in the groups of Comparative Examples 1-5, suggesting that the drug combination of the embodiment has the best effect, and the ratio should be within a specific range. The effects of the high-dose group of Example 1 and the group of Comparative Example 6 are not much different, indicating that the efficacy of the present invention is not reduced after the medicinal taste is simplified compared with Comparative Example 6.

[0192] The above results show that the high-dose group of Example 1, the groups of Examples 2-3, and the comparative example 6 can significantly increase the 5-HT and SP contents in constipated mice, and reduce the VIP content, thereby improving the gastrointestinal function of mice.

[0193] Table 5 Comparison of 5-HT, SP and VIP contents in colon tissue of mice in each group ( n=10)

[0194]

[0195]

[0196] In Table 5, compared with the model control group, * P<0.05, ** P<0.01, *** P < 0.001;

[0197] Compared with the low-dose group in Example 1, ◆ P<0.05, ◆◆ P<0.01, ◆◆◆ P < 0.001;

[0198] Compared with the high-dose group in Example 1, # P<0.05, ## P<0.01, ### P<0.001.

[0199] In terms of improving gastric bloating, the present invention selects Magnolia Bark Expelling Mixture as a positive medicine, which is composed of Magnolia Bark (processed with ginger), Aucklandia Root, Fructus Aurantii Immaturus (fried with bran), and Rhubarb, and has the effects of promoting qi and relieving bloating, relieving fullness, and is a new Chinese medicine with definite efficacy, mainly used to treat early intestinal paralysis after abdominal non-gastrointestinal anastomosis. In terms of improving gastrointestinal dysfunction, Baohe Pills are selected as a positive medicine, which is composed of 8 medicines, including charred hawthorn, Liushenqu (fried), Pinellia (processed), Poria, dried tangerine peel, Forsythia suspensa, Radish Seed, and Malt, and is from the "Danxi Heart Method" by Zhu Danxi, one of the "Four Great Masters of Jin and Yuan Dynasties", which records: Baohe Pills, treat all food accumulation. Baohe Pills are a classic representative prescription for treating food accumulation in traditional Chinese medicine. In terms of constipation, lactulose oral solution is chosen as the positive drug. The lactulose in lactulose oral solution is a prebiotic. Its metabolites in the body can promote the proliferation of beneficial intestinal bacteria such as bifidobacteria, while stimulating intestinal peristalsis and increasing the secretion of intestinal fluid. It effectively promotes the excretion of feces through osmosis and has a significant therapeutic effect on constipation.

[0200] Postoperative intestinal paralysis is caused by surgical trauma that temporarily weakens or stops intestinal motility, affecting the normal digestion and excretion of food and gas, which is consistent with the symptoms of "stomach bloating, abdominal distension" and so on. A postoperative intestinal paralysis rat model was established to explore the effect of this product on improving gastrointestinal stagnation. Atropine is an M cholinergic receptor blocker that competitively antagonizes the agonist effect of acetylcholine on M cholinergic receptors, inhibits gastrointestinal motility, has a short modeling time, and is effective in simulating symptoms, so it is used to induce a temporary gastrointestinal dysfunction mouse model; intragastric administration of iodoacetamide can induce cellular hypoxia and gastrointestinal mucosal damage, thereby causing an early inflammatory response, which can better simulate the pathological mechanism of visceral hypersensitivity. Therefore, an animal model of persistent gastrointestinal dysfunction with gastric motility disorder characteristics was established by first administering intragastric administration of iodoacetamide and then superimposing the modified small platform method, which has a higher degree of consistency with the clinical patient manifestations; loperamide hydrochloride is a peripheral opioid receptor agonist that can inhibit intestinal water secretion and colonic motility, delay fecal evacuation time and intestinal transit, and cause constipation symptoms by reducing the number, weight and water content of fecal particles in animals. Therefore, loperamide hydrochloride is used to prepare a constipation animal model.

[0201] In the results of this study, the postoperative intestinal paralysis experiment showed that the high-dose group of Example 1 can reduce gastric volume and improve small intestinal propulsion rate, and is significantly better than the low-dose group of Example 1 and Comparative Example 1-Comparative Example 5 groups (P<0.05, P<0.01, P<0.001), and there is no significant difference between the Houpo Qi Exhaust Mixture group, Example 2-Example 3 groups and Comparative Example 6 groups. The atropine-induced gastrointestinal dysfunction experiment showed that the high-dose group of Digestive Example 1 can improve gastric emptying rate and small intestinal propulsion rate, and is significantly better than the low-dose group of Example 1 and Comparative Example 1-Comparative Example 5 groups (P<0.05, P<0.01, P<0.001), and there is no significant difference between the Baohe Pill group and the Example 2-Example 3 groups. The gastrointestinal dysfunction experiment induced by iodoacetamide gavage combined with the small platform method shows that the high-dose group of Example 1 can improve the gastric emptying rate and the small intestinal propulsion rate, and is significantly better than the low-dose group of Example 1 and the comparative example 1-comparative example 5 groups (P<0.01, P<0.001), and there is no significant difference between the Baohe Pill group, the Example 2-Example 3 group and the comparative example 6 group. The constipation mouse experiment induced by loperamide hydrochloride shows that the high-dose group of Example 1 can reduce the time of the first black stool, and increase the number and focus of stool within 5h, and is significantly better than the low-dose group of Example 1 and the comparative example 1-comparative example 5 groups (P<0.01, P<0.001), and there is no significant difference between the lactulose oral liquid group, the Example 2-Example 3 group and the comparative example 6 group. The above results all show that the composition of the present invention has the effect of improving gastrointestinal function, and at the same time, it is suggested that the combination effect of the present invention is the best, and the combination ratio must be within a specific range.

[0202] In summary, the research results suggest that the composition of the present invention can significantly improve postoperative intestinal paralysis and gastrointestinal dysfunction in rats, and significantly improve constipation in mice. Its therapeutic effect is equivalent to that of the positive drug and the embodiment composition within the protective ratio range, and is better than the composition beyond the protective ratio range and the comparative example composition with different components. The simplified prescription of the present invention still has the significant effect of improving constipation, ventilation, and relieving abdominal distension and abdominal pain compared with the prescription with more flavor ingredients in the prior art.

[0203] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition having the functions of ventilation, relieving abdominal distension and pain, and improving constipation, characterized in that: Made from the following ingredients: hawthorn, malt, yam, chicken gizzard lining, tangerine peel and radish seeds.

2. The composition according to claim 1, characterized in that The invention is prepared from the following components by weight: 30-40 parts of hawthorn, 5-15 parts of malt, 1-5 parts of yam, 2-10 parts of chicken gizzard lining, 5-15 parts of orange peel and 3-10 parts of radish seeds.

3. The composition according to claim 2, characterized in that The invention is prepared from the following components by weight: 35 parts of hawthorn, 10 parts of malt, 2.6 parts of yam, 5 parts of chicken gizzard lining, 10 parts of orange peel and 5 parts of radish seeds.

4. A method for preparing the composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: The hawthorn, malt, yam, chicken gizzard lining, orange peel, radish seed and water are mixed, heated under reflux for extraction, and the extracts are combined to obtain an extract.

5. The preparation method according to claim 4, characterized in that: The heating reflux extraction is performed 1-4 times, and the solid-liquid ratio is 1g:5-20mL.

6. The preparation method according to claim 5, characterized in that: The heating reflux extraction was performed twice, with a solid-liquid ratio of 1 g:10 mL.

7. The preparation method according to claim 4, characterized in that: The heating reflux extraction is performed for 0.5-2h each time, and the extraction temperature is 90-100°C.

8. The preparation method according to claim 7, characterized in that: The heating reflux extraction is performed for 1 hour each time, and the extraction temperature is 95-100°C.

9. A drug, characterized in that The active ingredient comprises the composition according to any one of claims 1 to 3, or the extract prepared by the preparation method according to any one of claims 4 to 8.

10. Use of the composition according to any one of claims 1 to 3, or the extract prepared by the preparation method according to any one of claims 4 to 8, in the preparation of a product having at least one of the functions of ventilation, relieving abdominal distension and abdominal pain, and improving constipation.

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