A Chinese medicine composition and Chinese medicine granules for treating diarrhea-type spleen and kidney yang deficiency IBS

Abstract

The invention belongs to the field of Chinese medicine compositions and relates to a Chinese medicine composition and Chinese medicine granules for treating diarrhea-type spleen and kidney yang deficiency syndrome IBS. The Chinese medicine composition is composed of the following raw materials by weight: 6-12 grams of ginseng, 5-15 grams of julibrissin, 5-15 grams of fructus aurantii, 8-15 grams of atractylodes, 8-15 grams of atractylodes, 2-5 grams of pilose antler, 2-6 grams of evodia rutaecarpa, 3-9 grams of cordyceps, 15-20 grams of heartwood, 8-15 grams of red ochre, 3-10 grams of terminalia chebula, and 5-9 grams of roasted liquorice. The Chinese medicines are used together to jointly play the effects of invigorating the spleen and kidney, regulating qi and stopping diarrhea, and calming the nerves. It has been proved through many years of clinical trials that the prescription can effectively relieve the abdominal pain, loose stools, diarrhea and other symptoms of patients with diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome, improve the spleen and stomach function of patients, improve the quality of life, and has the advantages of fast onset, stable efficacy, high total effective rate, low recurrence rate and the like.

Description

Technical Field

[0001] The present invention belongs to the field of Chinese medicine compositions, and more specifically, relates to a Chinese medicine composition and Chinese medicine granules for treating diarrhea-type spleen and kidney yang deficiency irritable bowel syndrome (IBS). Background Art

[0002] Irritable bowel syndrome (IBS) is a functional intestinal condition that is often caused by multiple factors, leading to abnormal gut-brain interaction. Its main symptoms are abdominal pain, abnormal defecation, and changes in frequency and / or stool characteristics. Common types include diarrhea, constipation, mixed, and amorphous. The incidence of irritable bowel syndrome in the general population in China is approximately between 1.4% and 11.5%, but the actual number may be higher than this because many patients do not seek medical treatment. This disease can occur in people of all ages, but it is more common in young and middle-aged people (18-59 years old), and the prevalence in the elderly (≥60 years old) has decreased.

[0003] Irritable bowel syndrome is classified into liver depression and spleen deficiency syndrome, spleen deficiency and dampness syndrome, spleen and kidney yang deficiency syndrome, spleen and stomach dampness and heat syndrome, and cold and heat syndrome in traditional Chinese medicine. Currently, commonly used drugs include pinaverium bromide, dioctahedral montmorillonite, trimebutine and probiotics. These drugs have low total effective rate for the treatment of diarrhea-type spleen and kidney yang deficiency irritable bowel syndrome, are prone to recurrence, and have serious side effects.

[0004] Chinese patent CN 106729502 A discloses "a Chinese medicine composition for treating irritable bowel syndrome of spleen and kidney yang deficiency type and its preparation method". The Chinese medicine composition can treat irritable bowel syndrome of spleen and kidney yang deficiency type. However, from the perspective of Chinese medicine compatibility, the prescription for treating irritable bowel syndrome (IBS) of spleen and kidney yang deficiency type has the following potential deficiencies: (1) although aconite and dried ginger in the prescription are important yang-warming herbs, they mainly warm spleen yang, and their ability to warm and tonify kidney yang is slightly insufficient; (2) red ochre and euryale ferox are not enough to warm and tonify kidney yang. It can stop diarrhea, but only bergamot and Chuanxiong can promote qi and blood circulation, which may lead to qi stagnation due to excessive astringency; (3) Poria and Atractylodes can strengthen the spleen and eliminate dampness, but spleen and kidney yang deficiency is often accompanied by water retention, so diuresis needs to be strengthened; in addition, IBS is often related to liver depression, bergamot is slow in soothing the liver, and Chuanxiong is biased towards promoting blood circulation, so the combination of liver and spleen is not enough to coordinate; (4) Aconite, dried ginger, and Evodia rutaecarpa in the prescription are all pungent and hot, and long-term use can easily deplete yin fluid; in addition, aconite is toxic and improper decoction can easily cause adverse reactions. Because this prescription still has the above shortcomings, it will lead to unstable efficacy and easy recurrence. Summary of the invention

[0005] In view of the deficiencies in the prior art, the object of the present invention is to provide a Chinese medicine composition for treating diarrhea-type IBS with spleen and kidney yang deficiency syndrome. The Chinese medicine composition uses ginseng and pilose antler as the main ingredients. Ginseng greatly replenishes vital energy, nourishes the spleen and lungs, promotes the production of body fluids, and calms the nerves. Pit antler strengthens kidney yang, replenishes qi and blood, benefits the essence, strengthens tendons and bones, and directly attacks the core pathogenesis of spleen and kidney deficiency. Atractylodes macrocephala, Atractylodes lancea, and Cordyceps sinensis are used as the auxiliary ingredients, which can nourish the spleen and stomach, dry dampness and harmonize the middle, dispel wind and dissipate cold, and nourish the kidney and benefit the essence. Ginseng and pilose antler are used to enhance the effect of nourishing the spleen and kidney. Albizzia julibrissin and Citrus aurantium are used as the auxiliary ingredients, which can relieve depression, calm the nerves, and regulate qi. It can relieve fullness; Evodia rutaecarpa dispels cold and relieves pain, assists yang and stops diarrhea; Terminalia chebula is bitter, sour, warm and astringent, and is specifically good at astringing the intestines and stopping diarrhea; Red ochre and stove heart soil solidify and astringe the lower abdomen, astringe the intestines and stop dysentery; Roasted licorice is a messenger, which harmonizes all the medicines; all the medicines are used together to play the role of strengthening the spleen and kidney, regulating qi and stopping diarrhea, and calming and tranquilizing the mind. Many years of clinical trials have proved that this prescription can effectively relieve abdominal pain, loose stools, diarrhea and other symptoms in patients with diarrhea-type irritable bowel syndrome with spleen and kidney yang deficiency, improve the spleen and stomach function of patients, and improve the quality of life. It has the advantages of rapid onset, stable efficacy, high total effective rate and low recurrence rate.

[0006] To achieve the above object, the present invention adopts the following technical solution:

[0007] A traditional Chinese medicine composition for treating diarrhea-type IBS with spleen and kidney yang deficiency syndrome, the traditional Chinese medicine composition is composed of the following raw materials by weight: 6-12 grams of ginseng, 5-15 grams of julibrissin, 5-15 grams of fructus aurantii, 8-15 grams of atractylodes, 8-15 grams of atractylodes, 2-5 grams of pilose antler, 2-6 grams of evodia rutaecarpa, 3-9 grams of cordyceps, 15-20 grams of heartwood, 8-15 grams of red ochre, 3-10 grams of terminalia chebula, and 5-9 grams of roasted liquorice.

[0008] As a preferred embodiment of the present invention, the Chinese medicine composition is composed of the following raw materials by weight: 10-12 parts of ginseng, 12-15 parts of julibrissin flowers, 9-15 parts of fructus aurantii, 10-15 parts of atractylodes, 10-15 parts of atractylodes, 10-15 parts of atractylodes, 3-5 parts of pilose antler, 4-6 parts of evodia rutaecarpa, 5-9 parts of cordyceps, 17-20 parts of heartwood, 10-15 parts of red ochre, 5-10 parts of terminalia chebula, and 6-9 parts of roasted licorice.

[0009] As a preferred embodiment of the present invention, the Chinese medicine composition is composed of the following raw materials by weight: 10-12 parts of ginseng, 12-15 parts of flos julibrissin, 12-15 parts of fructus aurantii, 13-15 parts of atractylodes, 13-15 parts of atractylodes, 4-5 parts of pilose antler, 5-6 parts of evodia rutaecarpa, 7-9 parts of cordyceps, 19-20 parts of heartwood soil, 13-15 parts of red ochre, 7-10 parts of terminalia chebula, and 8-9 parts of roasted licorice.

[0010] The above-mentioned Chinese medicine composition provided by the present invention has been proved through clinical trials that it can effectively relieve the symptoms of abdominal pain, loose stools, diarrhea, etc. in patients with diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome, improve the spleen and stomach function of patients, and improve the quality of life. It has the advantages of rapid onset, stable efficacy, high total effective rate, low recurrence rate (follow-up recurrence rate within 2 years is less than 3%), etc. Therefore, the Chinese medicine composition can be used in the preparation of drugs for diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS).

[0011] The dosage form of the drug for treating diarrhea-type spleen and kidney yang deficiency irritable bowel syndrome (IBS) of the present invention is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, oral liquids or pills.

[0012] The present invention also provides a Chinese medicine granule for treating diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS), the Chinese medicine granule comprising a main drug component and auxiliary materials; wherein the main drug component is prepared by processing the above-mentioned Chinese medicine composition as a raw material.

[0013] As a preferred embodiment of the present invention, the preparation method of the main drug component comprises the following steps:

[0014] Ginseng is crushed, passed through an 80-100 mesh sieve, and crushed with an ultrafine grinder to an average particle size of less than 2 microns to obtain ultrafine ginseng powder for later use;

[0015] Albizzia julibrissin, add water and boil for 1-3 times, each time for 1-2 hours, filter, combine the filtrate, concentrate to an extract with a relative density of 1.08-1.12 at 60°C, add ethanol and stir until the alcohol content reaches 60%, let stand, filter, take the supernatant and concentrate to an extract with a relative density of 1.20-1.25 at 60°C, dry under reduced pressure, take the dry extract and grind it into fine powder for later use;

[0016] Add water to fructus aurantii, terminalia chebula, red ochre and heartwood, and boil for 1-3 times, each time for 15-60 minutes, filter, combine the filtrate, and concentrate the filtrate to an extract with a relative density of 1.0-1.3 at 70°C, and set aside;

[0017] Add water to white atractylodes, atractylodes and licorice, and boil for 1-3 times, each time for 15-30 minutes. Combine the decoctions, filter them, and concentrate them into a clear paste with a relative density of 1.04-1.06 at 60°C for later use.

[0018] The antlers are crushed and passed through a 30-mesh sieve to obtain antler powder; the antler powder is then soaked in an entrainer for 1 hour and then put into an extraction kettle, wherein the entrainer is 75% ethanol; the SFE supercritical fluid preparation system is heated, and when the temperature reaches 50°C and the pressure reaches 30 MPa, dynamic extraction is performed for 3 hours, the material is connected from the outlet valve, and the entrainer is removed by vacuum decompression and drying to obtain antler extract for standby use;

[0019] Evodia rutaecarpa, add water and decoct for 1-3 times, soak for 1-2 hours before the first decoction, and decoct for 1-2 hours each time; filter, combine the filtrate, concentrate to an extract with a relative density of 1.33 at 60°C, vacuum dry to obtain extract powder, and set aside;

[0020] Soak Cordyceps sinensis for 1.5 hours, crush the Cordyceps sinensis fruiting body, pass through an 80-mesh sieve and add it into a supercritical CO2 extraction cell; the parameters are set as follows: pressure 20Mpa; extraction cell temperature 50℃, desorption temperature 40℃; static extraction 10min, dynamic extraction 75min; CO2 flow rate 1.0L / min, and obtain a yellow transparent oily substance for standby use;

[0021] The main medicinal ingredients are prepared by mixing ultrafine ginseng powder, fine powder of julibrissin flower, extracts of fructus aurantii, chebula chebula, red ochre and hearth soil, clear pastes of atractylodes macrocephala, atractylodes lancea and licorice root, deer antler extract, extract powder of evodia rutaecarpa and cordyceps sinensis oil, drying under reduced pressure and grinding into fine powder.

[0022] In the Chinese medicine composition provided by the present invention:

[0023] Ginseng: sweet, slightly bitter, warm in nature, and enters the spleen, lung, and heart meridians. It has the effects of greatly replenishing vital energy, restoring pulse and strengthening deficiency, replenishing spleen and lung, promoting body fluid and nourishing blood, and calming the mind and improving intelligence. In this recipe, ginseng can replenish spleen qi, enhance the transportation and transformation function of spleen and stomach, make spleen qi healthy, and transport water and moisture, thereby improving symptoms such as abdominal distension and loose stools. Ginsenosides and ginseng polysaccharides are the main components of ginseng and have multiple pharmacological activities. Ginsenosides can regulate the central nervous system, produce a sedative effect, effectively relieve anxiety, and improve sleep. At the same time, they can also promote the production of hemoglobin and improve the body's hematopoietic function, thereby achieving the purpose of replenishing qi and nourishing blood. Ginseng polysaccharides are another important active ingredient in ginseng, which has pharmacological effects such as enhancing immunity and anti-tumor. In terms of tonifying the spleen, ginseng polysaccharides can assist in enhancing the function of the spleen and promote the absorption and utilization of nutrients by the spleen. In the present invention, ginseng is used as medicine in the form of ultrafine powder, which can more effectively utilize active ingredients such as ginsenosides, significantly improve bioavailability, and make the drug effect more fully exerted.

[0024] Deer antler: sweet and warm, salty in nature, enters the kidney and liver meridians, replenishes kidney yang, benefits essence and blood, strengthens tendons and bones, warms and replenishes kidney yang, replenishes kidney essence, and directly attacks the pathogenesis of kidney deficiency. Together with ginseng, it is the main medicine, strengthens the spleen and kidney, and directly attacks the core pathogenesis of spleen and kidney deficiency, and is the master of the whole prescription. Deer antler contains rich amino acids, accounting for more than half of the total ingredients. These amino acids play an important role in maintaining the normal function of the kidneys and promoting kidney repair. Amino acids are the basic units of protein and are essential for cell growth, repair and metabolism. Lipid components such as phospholipids, glycolipids, and gum lipids play an important role in maintaining the integrity and stability of kidney cell membranes, and can enhance the kidney's disease resistance and repair ability. In addition, deer antler contains a variety of hormone components, such as testosterone and estradiol. These hormones can regulate the body's endocrine system and promote the metabolism and detoxification function of the kidneys. At the same time, they can also simulate or supplement the hormones naturally produced in the body, thereby improving various symptoms caused by kidney deficiency. Deer antler contains calcium, phosphorus, magnesium, sodium and other trace elements. Calcium and phosphorus are important components of bones and teeth, and are essential for maintaining the balance of bone metabolism in the kidneys. Magnesium participates in the catalytic reaction of multiple enzymes in the body and plays an important role in maintaining the metabolic function of the kidneys. In the present invention, deer antler is not directly added, but the deer antler is extracted to obtain deer antler extract. The active ingredients in the deer antler extract obtained in this way are more easily absorbed and utilized by the human body. At the same time, due to the high concentration of active ingredients in the deer antler extract, the dosage can be reduced, reducing the economic burden of patients.

[0025] Atractylodes macrocephala: bitter in taste, sweet and warm in nature, belongs to the spleen and stomach meridians, strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, and is an important medicine for tonifying the spleen. The volatile oil components of Atractylodes macrocephala have the effect of promoting the secretion of digestive juices and enhancing appetite. The active substances in the volatile oil can stimulate the gastrointestinal mucosa, increase gastrointestinal motility, thereby improving the spleen and stomach function, and promoting the digestion and absorption of food. This has a significant improvement effect on symptoms such as indigestion and loss of appetite caused by spleen deficiency. Atractylodes lactone has the effect of inhibiting the excitability of the sympathetic nervous system, can reduce the amount of sweating, and has a certain therapeutic effect on spontaneous sweating, night sweats and other diseases. Atractylodes lactone can regulate the spleen and stomach function, promote the generation and transportation of qi and blood, and thus improve various symptoms caused by spleen deficiency. The polysaccharide components in Atractylodes macrocephala have the effect of enhancing immunity, can stimulate the body to produce immune cells, increase the activity of immune cells, and thus enhance the body's disease resistance.

[0026] Atractylodes: Spicy and bitter in taste, warm in nature, enters the spleen and stomach meridians, dries dampness and strengthens the spleen, dispels wind and removes dampness. When used together with Atractylodes macrocephala, it can strengthen the spleen and dry dampness, enhance the spleen and stomach transportation and transformation functions, and improve the symptoms of spleen deficiency and dampness. Atractylodes is rich in volatile oil components, containing atractylol, atractylone and other active substances, which can promote the transportation and transformation functions of the spleen and stomach, eliminate dampness, and thus restore the normal function of the spleen and stomach. Volatile oil also has antibacterial and anti-inflammatory effects, which helps to enhance the body's immunity and further protect the health of the spleen and stomach. The vitamin A substances contained in Atractylodes may indirectly play a spleen-tonifying role by promoting cell growth and repair, and enhancing the disease resistance of spleen and stomach cells. Atractylodes contains a variety of amino acids and trace elements, which promote the generation and transportation of qi and blood by participating in the metabolism and repair process of spleen and stomach cells.

[0027] Cordyceps sinensis: sweet and mild, it enters the lung and kidney meridians, nourishes the lungs and kidneys, relieves cough and resolves phlegm, can nourish kidney yang, and can benefit the spleen and lungs, cooperate with ginseng and deer antler to nourish the spleen and kidneys, enhance the power of the whole prescription to nourish the kidney and benefit the essence, and is a ministerial drug together with Atractylodes macrocephala and Atractylodes macrocephala. The polysaccharide components and cordycepic acid in Cordyceps sinensis have antioxidant effects, can protect cells from free radical damage, can stimulate the activity of immune cells, promote the release of immune factors, and thus enhance the body's immunity. In the present invention, Cordyceps sinensis is subjected to supercritical CO2 extraction, and this method can obtain high-purity Cordyceps sinensis effective ingredients, such as nucleosides, fatty acids, sterols, etc., and at the same time, the extract has a small particle size and good dispersibility, is more easily absorbed and utilized by the human body, and avoids impurities and pollutants that may be produced in traditional extraction methods.

[0028] Albizzia julibrissin: It is mild in nature, sweet in taste, and is good for the heart and liver meridians. It can relieve depression and soothe the mind. It targets liver depression and qi stagnation caused by emotional distress, and alleviates the impact of emotional factors on intestinal function. Albizzia glycoside is one of the main active ingredients in Albizzia julibrissin, which has a calming and soothing effect. It can act on the central nervous system, inhibit excessive excitement of neurons, and thus relieve symptoms such as anxiety and insomnia. The volatile oil compounds in Albizzia julibrissin also have a certain sedative effect. These compounds can regulate the activities of the nervous system and relieve tension. In the present invention, Albizzia julibrissin is first extracted with water, and then the alcohol-soluble part is concentrated. This method can fully extract the effective ingredients such as flavonoids in Albizzia julibrissin, which helps to affect the function of the central nervous system by improving the intestinal microecological environment, regulating intestinal neurotransmitters, etc., thereby avoiding abnormal intestinal-brain interaction and improving clinical symptoms.

[0029] Citrus aurantium: bitter and sour, slightly pungent, slightly cold, enters the lung, spleen, stomach, and large intestine meridians, regulates qi and relieves fullness, relieves stagnation and distension, improves intestinal qi stagnation, and relieves symptoms such as abdominal distension and abdominal pain. The volatile oils of Citrus aurantium mainly include limonene, geraniol, etc. Flavonoids such as hesperidin, aurantium glycosides, coniferin, naringenin-7-rutinoside, etc. These compounds have multiple biological activities such as antioxidant and anti-inflammatory.

[0030] Evodia rutaecarpa: Spicy and bitter in taste, hot in nature, enters the liver, spleen, stomach, and kidney meridians, warms the middle and dispels cold, soothes the liver and lowers the qi, can dispel cold and relieve pain, reduce adverse reactions and stop vomiting, help yang and stop diarrhea, relieve vomiting caused by liver depression and qi stagnation, stomach disharmony, and diarrhea caused by spleen and kidney yang deficiency. It has an aromatic stomachic effect, can remove gas accumulation in the intestine and inhibit abnormal fermentation in the intestine, increase digestive juice secretion, inhibit gastrointestinal motility and relieve spasm and stop vomiting, and has analgesic, anti-gastric ulcer, blood pressure lowering, uterine excitement, anti-thrombosis, insecticide, antibacterial, temperature raising, liver protection and gallbladder, inhibit central nervous system, improve cardiovascular system function, anti-thrombosis, anti-hypoxia and other pharmacological effects. Evodia rutaecarpa fruit contains a variety of volatile oil components, among which evodiene is its main component, with a content of up to 30%. In addition, it also includes other volatile oil components such as ocimene, evodiolide, and evodiolide alcohol. Evodia rutaecarpa contains a variety of alkaloid components, such as evodiamine, evodiamine, evodiamine, hydroxyevodiamine, evodiamine carpine, etc. These alkaloid components have a variety of pharmacological effects such as analgesia, increasing body temperature, and mildly affecting respiration and blood pressure.

[0031] Red ochre and hearth soil are both astringent and antidiarrheal. Red ochre tastes sweet, sour, astringent, and warm in nature. It enters the large intestine and stomach meridians, astringent and antidiarrheal, astringent and hemostatic; hearth soil tastes spicy and warm in nature. It enters the spleen and stomach meridians, warms the middle and stops bleeding, stops vomiting and stops diarrhea. The two are used together to enhance the antidiarrheal effect and improve diarrhea caused by spleen and kidney yang deficiency. The aluminum silicate contained in red ochre can absorb toxins in the digestive tract, such as phosphorus, mercury, bacterial toxins, abnormal fermentation products, and inflammatory exudates; aluminum silicate can cover the intestinal mucosa, reduce the irritation of these harmful substances to the gastrointestinal tract, and thus play an antidiarrheal role. The components such as aluminum oxide and ferric oxide in hearth soil have astringent and hemostatic effects, which help relieve intestinal inflammation and bleeding caused by diarrhea; components such as silicic acid help protect the intestinal mucosa, reduce the irritation of harmful substances to the intestine, and thus alleviate diarrhea symptoms.

[0032] Terminalia chebula: It is flat in nature, bitter, sour, and astringent in taste. It belongs to the lung and large intestine meridians, astringes the intestines to stop diarrhea, astringes the lungs to stop coughing, further enhances the function of astringing the intestines to stop diarrhea, and cooperates with red ochre and hearth soil to relieve diarrhea. It is used as an adjuvant with Flos Albizziae, Fructus Aurantii Immaturus, Fructus Evodiae, red ochre, and hearth soil. Terminalia chebula fruit contains 20% to 40% tannins, which have an astringent effect and can reduce the secretion of water and electrolytes in the intestine, thereby alleviating the symptoms of diarrhea. In addition, tannins can also combine with harmful substances in the intestine to form precipitation, reducing their irritation and damage to the intestine. Terminalia chebula also contains terminalia acid derivatives such as terminalia acid, terminalia acid, and terminalia chebula acid triethyl ester. These ingredients also have astringent effects, can enhance the barrier function of the intestinal mucosa, and reduce the damage of harmful substances in the intestine to the intestinal mucosa. In addition, they can also promote the repair and regeneration of the intestinal mucosa, helping to restore the normal function of the intestine.

[0033] Roasted licorice: sweet in taste, neutral in nature, enters the heart, lung, spleen, and stomach meridians, harmonizes various medicines, tonifies the spleen and replenishes qi, relieves acute and acute pain, can not only enhance the tonic effect of the monarch and ministerial medicines, but also relieves abdominal pain and other discomforts, and is the messenger of the whole prescription.

[0034] Advantages and beneficial effects of the present invention:

[0035] (1) The Chinese medicine composition provided by the present invention uses ginseng and deer antler as the main ingredients. Ginseng greatly replenishes vital energy, nourishes the spleen and lungs, promotes the production of body fluids, and calms the nerves. Deer antler strengthens kidney yang, replenishes qi and blood, benefits the essence, and strengthens the tendons and bones, directly attacking the core pathogenesis of spleen and kidney deficiency. Atractylodes macrocephala, Atractylodes lancea, and Cordyceps sinensis are used as the auxiliary ingredients, which can nourish the spleen and stomach, dry dampness and harmonize the middle, dispel wind and dissipate cold, and nourish the kidney and benefit the essence. Ginseng and deer antler work together to enhance the effect of nourishing the spleen and kidney. Flos albizziae and Fructus Aurantii Immaturus are used as adjuvants to relieve depression and calm the nerves, regulate qi and relieve fullness. Evodia rutaecarpa dispels cold and relieves pain, promotes yang and stops diarrhea. Terminalia chebula is bitter, sour, warm and astringent. , which is specialized in astringing the intestines and stopping diarrhea; red ochre and stove heart soil astringe the lower part of the body, astringe the intestines and stop dysentery; roasted licorice is used as a messenger to harmonize the various medicines; the combination of various medicines can jointly play the role of strengthening the spleen and kidney, regulating qi and stopping diarrhea, and calming and tranquilizing the mind. It can effectively relieve the abdominal pain, loose stools, diarrhea and other symptoms of patients with diarrhea-type irritable bowel syndrome with spleen and kidney yang deficiency, improve the spleen and stomach function of patients, and improve the quality of life. It has the advantages of rapid onset, stable efficacy, high total effective rate (up to 97%), and low recurrence rate (the recurrence rate within 2 years of follow-up is less than 3%).

[0036] (2) The Chinese medicine composition provided by the present invention is composed entirely of Chinese herbal medicines with scientific proportions and no toxic side effects caused by long-term use of Western medicines. The prescription breaks through the ancient prescription, has a pure combination (precise compatibility relationship, fine preparation process, pure prescription purpose, and can provide precise and efficient treatment), is safe and effective, and the prepared granules have the advantages of being easy to take and carry and having high bioavailability.

[0037] (3) In the preparation of the main medicinal ingredient of the Chinese herbal granules for treating diarrhea-type irritable bowel syndrome with spleen and kidney yang deficiency provided by the present invention, ultrafine powder of ginseng is used. This method can more effectively utilize active ingredients such as ginsenosides, significantly improve bioavailability, and make the drug effect more fully exerted; in addition, deer antler is not directly added, but the deer antler is extracted and the deer antler extract is used as medicine. In this way, the active ingredients in the deer antler extract are more easily absorbed and utilized by the human body. In addition, its high concentration characteristics effectively reduce the dosage, thereby reducing the economic burden on patients; furthermore, the flowers of the Albizzia Julibrissin are first extracted with water, and then the alcohol-soluble part is concentrated. This method can deeply extract the core ingredients such as flavonoids in the flowers of the Albizzia Julibrissin, which helps to optimize the intestinal microecology. , regulating intestinal neurotransmitters and other mechanisms, which has a positive impact on the central nervous system, thereby effectively avoiding abnormal gut-brain interaction and effectively improving clinical symptoms; Cordyceps sinensis is subjected to supercritical CO2 extraction. This method is low-temperature and efficient, and can obtain high-purity effective ingredients of Cordyceps sinensis, such as nucleosides, fatty acids, sterols, etc. The extraction rate of flavonoids in Cordyceps sinensis can reach 0.3%-0.35%, which is more than 15% higher than that of the traditional solvent method, and the extraction time is shortened to 2-7 hours, which is suitable for large-scale production; in addition, the obtained extract has a small particle size and is evenly dispersed, which greatly improves the absorption efficiency of the human body, while avoiding impurities and pollutants that may be introduced by traditional extraction methods, ensuring the purity and safety of the product.

[0038] (4) In the Chinese medicine granules for treating diarrhea-type irritable bowel syndrome with spleen and kidney yang deficiency provided by the present invention, ginsenosides and other ingredients in ginseng can stimulate the activity of the immune system, improve the body's ability to resist pathogens such as viruses and bacteria, and have a bidirectional regulatory effect on the central nervous system, which can not only improve the excited state of the nervous system, but also relieve symptoms such as nervous tension and anxiety, stimulate gastric juice secretion, promote appetite, and improve digestive function, thereby indirectly affecting the nervous system and immunity by regulating intestinal health; the antidepressant and sedative effects of Albizzia julibrissin may improve the structure of intestinal microbial communities, thereby affecting the synthesis and release of neurotransmitters, thereby regulating the function of the nervous system; Citrus aurantium can regulate the digestive system, promote gastrointestinal motility, and increase gastric juice secretion, thereby improving Intestinal health indirectly affects the function of the nervous system; Atractylodes can strengthen the spleen and appetite, remove dampness and relieve pain, and improve intestinal health; Atractylodes can enhance the body's immunity, promote blood circulation, improve symptoms such as anemia and fatigue, has a calming and antiperspirant effect, can relieve neurological symptoms such as anxiety and insomnia, can enhance the function of the spleen and stomach, promote digestion and absorption, and improve intestinal discomfort; Deer antler can improve the body's cellular and humoral immune function, promote lymphocyte transformation, act as an immune promoter, can enhance the tension of parasympathetic nerve endings, and improve the function of the nervous and muscular systems; Roasted Licorice has the function of harmonizing the medicinal properties and tonifying the middle and replenishing Qi, has an indirect regulatory effect on the immunity and nervous system, can harmonize the spleen and stomach, improve digestive function, and thus affect the function of the nervous system through intestinal health. The "nerve-gut" interaction mechanism of IBS provides a key target for treatment. The present invention regulates the function of the brain-gut axis through multi-components and multi-pathways of traditional Chinese medicine, which can not only regulate 5-HT and GABA to quickly intervene in symptoms, but also regulate the HPA axis and vagus nerve from the neuroendocrine level to maintain the therapeutic effect, ultimately achieving the treatment goal of rapid onset and low recurrence rate. DETAILED DESCRIPTION

[0039] The present invention discloses a Chinese medicine composition, a Chinese medicine granule and a preparation method for treating diarrhea-type spleen and kidney yang deficiency irritable bowel syndrome (IBS). Those skilled in the art can refer to the content of this article and appropriately improve the component parameters or process parameters to achieve it. It should be particularly pointed out that all similar substitutions and modifications are obvious to those skilled in the art, and they are all deemed to be included in the scope of protection of the present invention.

[0040] Embodiment 1:

[0041] The present embodiment provides a traditional Chinese medicine composition for treating diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS), the traditional Chinese medicine composition is composed of the following raw materials by weight: 12 parts of ginseng, 15 parts of flos julibrissin, 15 parts of fructus aurantii, 15 parts of atractylodes, 15 parts of atractylodes, 5 parts of pilose antler, 6 parts of evodia rutaecarpa, 9 parts of cordyceps, 20 parts of heartwood soil, 15 parts of red ochre, 10 parts of terminalia chebula, and 9 parts of roasted liquorice.

[0042] Embodiment 2:

[0043] This embodiment provides a Chinese medicine granule for treating diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS), the Chinese medicine granule comprising a main drug component and auxiliary materials; wherein the main drug component is prepared by processing the Chinese medicine composition described in Example 1 as a raw material.

[0044] In this embodiment, the specific preparation method of the main drug component includes the following steps:

[0045] Ginseng is crushed, passed through an 80-100 mesh sieve, and crushed with an ultrafine grinder to an average particle size of less than 2 microns to obtain ultrafine ginseng powder for later use;

[0046] Albizzia julibrissin, add 12 times of water, decoct and extract twice, 2 hours each time, filter, combine the filtrate, concentrate to an extract with a relative density of 1.08-1.12 at 60°C, add ethanol and stir until the alcohol content reaches 60%, let stand, filter, take the supernatant and concentrate to an extract with a relative density of 1.20-1.25 at 60°C, dry under reduced pressure at 60-75°C, take the dry extract and grind it into fine powder for later use;

[0047] Add 10 times the amount of water to Fructus Aurantii Immaturus, Terminalia Chebula, Ophiopogon japonicus, and Stovetopterygium wilfordii, decoct and extract twice, each time for 30 minutes, filter, combine the filtrates, and concentrate the filtrates to an extract with a relative density of 1.0-1.3 at 70°C, and set aside;

[0048] Add 10 times the amount of water to Atractylodes macrocephala, Atractylodes lancea and Glycyrrhiza uralensis, decoct and extract twice, each time for 20 minutes, combine the decoctions, filter them, and concentrate them into a clear paste with a relative density of 1.04-1.06 at 60°C for later use;

[0049] The antlers were crushed and passed through a sieve with a pore size of about 550 μm (30 mesh) to obtain antler powder; the antler powder was then soaked in an entrainer (75% ethanol) for 1 hour and then put into an extraction kettle, and the SFE supercritical fluid preparation system was heated. When the temperature reached 50°C and the pressure reached 30 MPa, dynamic extraction was performed for a predetermined time (3 hours), and the material was connected from the outlet valve, and the entrainer was removed by vacuum decompression and drying to obtain antler extract for later use;

[0050] Evodia rutaecarpa, add water and decoct for 3 times. Soak for 1.5 hours before the first decoction, add 8 times the amount of water, and extract for 1.5 hours; add 6 times the amount of water for the second and third decoctions, and extract for 1 hour respectively; filter, combine the filtrate, concentrate to an extract with a relative density of 1.33 at 60°C, vacuum dry, and obtain the extract powder for later use;

[0051] Soak Cordyceps sinensis for 1.5 hours, crush the Cordyceps sinensis fruiting body, pass through an 80-mesh sieve, and add 10 ml of supercritical CO2 extraction cell; the parameters are set as follows: pressure 20 MPa; extraction cell temperature 50 ° C, desorption temperature 40 ° C; static extraction 10 min, dynamic extraction 75 min; CO2 flow rate 1.0 L / min, and obtain a yellow transparent oily substance for standby use;

[0052] Mix ginseng ultrafine powder, julibrissin flower powder, extracts of Citrus aurantium, Terminalia chebula, red ochre, heartwood, clear paste of Atractylodes macrocephala, Atractylodes lancea, and licorice, antler extract, Evodia rutaecarpa extract powder, and cordyceps sinensis oil, dry under reduced pressure at 80°C, and grind into fine powder to obtain the main drug component;

[0053] After obtaining the main drug component, the main drug component and the auxiliary materials are mixed according to the conventional method to prepare the granules.

[0054] Specifically, starch (1-1.2 parts) and dextrin (3-3.5 parts) are added to the above main drug components, mixed evenly, made into granules with ethanol as a wetting agent, and dried at low temperature to obtain the product.

[0055] Embodiment 3:

[0056] The present embodiment provides a traditional Chinese medicine composition for treating diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS), the traditional Chinese medicine composition is composed of the following raw materials by weight: 10 parts of ginseng, 12 parts of flos julibrissin, 12 parts of fructus aurantii, 13 parts of atractylodes, 13 parts of atractylodes, 4 parts of pilose antler, 5 parts of evodia rutaecarpa, 7 parts of cordyceps, 19 parts of heartwood soil, 13 parts of red ochre, 7 parts of terminalia chebula, and 8 parts of roasted liquorice.

[0057] Embodiment 4:

[0058] This embodiment provides a Chinese medicine granule for treating diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS), which is different from Example 2 in that the main drug component is the Chinese medicine composition described in Example 3 as a raw material.

[0059] Embodiment 5:

[0060] This embodiment provides a Chinese medicine granule for treating diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome (IBS), which is different from Example 4 in that the preparation method of the main drug component is different;

[0061] Specifically, the preparation method of the main drug component is:

[0062] Ginseng, Atractylodes macrocephala, Atractylodes lancea, etc. are sliced, dried, crushed and passed through a 40-mesh sieve for later use.

[0063] Stove core soil is calcined and crushed; red ochre is calcined and ground into fine powder, and then decocted separately for 30 minutes, and then decocted with other medicinal materials;

[0064] Deer antler is dried at low temperature and then ultrafinely ground to obtain deer antler powder; Cordyceps sinensis is ground into fine powder; Albizzia julibrissin, Fructus Aurantii Immaturus and Evodia rutaecarpa are respectively ground into coarse powder (passed through a 10-20 mesh sieve), heated to boiling with 10 times the amount of water, and distilled for 2-3 hours while maintaining a slightly boiling state until the volatile oil is completely extracted, the oil-water mixture is collected, and the volatile oil is separated after standing and stratification (the oil is collected for later use), and the residue is then decocted together with other medicinal materials.

[0065] Add water to ginseng, Atractylodes macrocephala, Atractylodes lancea, Terminalia chebula, and licorice root and boil twice. Boil 8 times the amount of water for 1.5 hours the first time, and boil 6 times the amount of water for 1 hour the second time. Combine the filtrates.

[0066] Combine the above liquid medicines, concentrate under reduced pressure to a clear paste with a relative density of 1.10-1.15 (measured at 60°C), encapsulate the volatile oils of Albizzia julibrissin with β-cyclodextrin, mix with the clear paste, and spray dry (inlet air temperature 160°C, outlet air temperature 80°C) to obtain dry extract powder.

[0067] Dry extract powder + velvet antler / cordyceps powder + auxiliary materials (dextrin: lactose = 2:1), granulate with ethanol wet method (ethanol concentration 70%), pass through 14 mesh sieve, dry at 60℃ to moisture ≤5%, and package in sealed moisture-proof aluminum foil bags.

[0068] The method of using the Chinese medicine granules for treating diarrhea-type spleen and kidney yang deficiency syndrome (IBS) provided in this embodiment is: 1 bag each time (1 bag is 6 g), 3 times / d, 7 days as a course of treatment, the course of treatment is determined according to the patient's condition, usually 2-8 courses of treatment.

[0069] It should be noted that the Chinese medicine granules provided in this embodiment can be appropriately added or subtracted according to the severity of the patient's symptoms and the length of the course of the disease when used clinically. For example, for patients with severe spleen deficiency and dampness, the amount of Atractylodes macrocephala can be increased to 15 parts; for patients with yin deficiency and internal heat, the amount of Evodia rutaecarpa can be reduced to 3 parts; for patients with a shorter course of disease (acute stage), the amount of red ochre can be increased to 15 parts; of course, the amount of each raw material of the above-mentioned Chinese medicine granules needs to be controlled within the following range no matter how it is added or subtracted:

[0070] Ginseng 6-12, Albizzia julibrissin 5-15, Citrus aurantium 5-15, Atractylodes lancea 8-15, Atractylodes macrocephala 8-15, Deer antler 2-5, Evodia rutaecarpa 2-6, Cordyceps sinensis 3-9, Heartwood soil 15-20, Red ochre 8-15, Terminalia chebula 3-10, and Licorice root 5-9.

[0071] The Chinese medicine granules provided in this embodiment use ginseng and pilose antler as the main ingredients. Ginseng greatly replenishes vital energy, nourishes the spleen and lungs, promotes the production of body fluids, and calms the nerves. Pit antler strengthens kidney yang, replenishes qi and blood, benefits the essence, strengthens tendons and bones, and directly attacks the core pathogenesis of spleen and kidney deficiency. Atractylodes macrocephala, Atractylodes lancea, and Cordyceps sinensis are used as the auxiliary ingredients, which can nourish the spleen and stomach, dry dampness and harmonize the middle, dispel wind and dissipate cold, and nourish the kidney and benefit the essence, and cooperate with ginseng and pilose antler to enhance the effect of nourishing the spleen and kidney. Flos Albiziae and Fructus Aurantii Immaturus are used as adjuvants to relieve depression and calm the nerves, regulate qi and relieve fullness. Evodia rutaecarpa dispels cold and relieves pain, and assists yang and stops diarrhea. Terminalia chebula is bitter, sour, warm and astringent, and has the function of astringing the intestines and stopping diarrhea. Red ochre and heart of stove earth consolidate and astringe the lower jiao, astringe the intestines and stop dysentery. Roasted licorice is used as a messenger to harmonize the various medicines. The combination of the various medicines can jointly play the effects of strengthening the spleen and kidney, regulating qi and stopping diarrhea, and calming the nerves. The Chinese medicine granules have been used for many years in the Third Clinical Affiliated Hospital of Changchun University of Chinese Medicine and Ying's Chinese Medicine Clinic, and have a good therapeutic effect on patients with diarrhea-type spleen and kidney yang deficiency irritable bowel syndrome (IBS). The following clinical data illustrate the therapeutic effect of the Chinese medicine granules of the present invention, and the specific situation is as follows:

[0072] 1. Case selection: 280 patients with diarrhea-type spleen and kidney yang deficiency type irritable bowel syndrome were selected (diagnostic criteria: after excluding organic lesions, they meet the TCM spleen and kidney yang deficiency syndrome, with the main symptoms of diarrhea; abdominal pain; chills and cold limbs. Secondary symptoms: pale or sallow complexion; fatigue, shortness of breath and laziness; loss of appetite, abdominal distension; frequent urination at night, clear and long urination; pale and fat tongue with teeth marks on the edges, white and slippery tongue coating; deep and thin or slow pulse.), all from the outpatient department of gastroenterology of the Third Clinical Affiliated Hospital of Changchun University of Chinese Medicine, and were randomly divided into 4 groups, 70 cases in each group; treatment Treatment group 1: 33 males and 37 females, with an average age of 22-61 years old and a disease course of 1 month to 1 year; treatment group 2: 41 males and 29 females, with an average age of 20-58 years old and a disease course of 3 months to 1.5 years; treatment group 3: 36 males and 34 females, with an average age of 17-53 years old and a disease course of 1 month to 1 year; control group: 31 males and 39 females, with an average age of 20-65 years old and a disease course of 3 months to 1 year. There was no significant difference in gender, age, disease course and condition among the four groups, and the groups were comparable.

[0073] 2. Treatment methods:

[0074] Control group: montmorillonite powder, produced by Hainan Xiansheng Pharmaceutical Co., Ltd., with a specification of 3 grams per bag. Use the control sample, 1 bag each time, 3 times / d, 7 days as a course of treatment, and 4 courses of treatment are used.

[0075] Treatment group 1, treatment group 2, and treatment group 3 respectively used the Chinese medicine granules of Example 2, Example 4, and Example 5 for patients who met the criteria, 1 bag each time, 3 times / d, 7 days as a course of treatment, and 4 courses of treatment were used.

[0076] 3. Efficacy determination:

[0077] The evaluation of syndrome efficacy was conducted in accordance with the "Guidelines for Clinical Research of New Chinese Medicines (Trial)". According to the severity of the symptoms, the main and secondary symptoms (diarrhea frequency, stool characteristics, abdominal pain, chills and cold limbs, cold pain in the waist and knees, fatigue, loss of appetite, and frequent urination at night) were divided into 4 levels, and different scores were assigned to each level: 0 point: no symptoms; 1 point: mild (mild symptoms, not affecting daily life); 2 points: moderate (obvious symptoms, partially affecting daily life); 3 points: severe (severe symptoms, seriously affecting daily life). The nimodipine method was used to calculate: efficacy index = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%, which was divided into 4 levels: clinical cure, marked effect, effective, and ineffective.

[0078] 1) Clinical recovery: major symptoms and signs disappear or almost disappear, with efficacy index ≥ 95%;

[0079] 2) Significantly effective: major symptoms and signs were significantly improved, with efficacy index of 70%≤<95%;

[0080] 3) Effective: The main symptoms and signs improved significantly, with the efficacy index of 30%≤<70%;

[0081] 4) Ineffective: There is no significant improvement in the main symptoms and signs, or they may even worsen, and the efficacy index is less than 30%.

[0082] 4. Treatment results

[0083] Table 1 shows the treatment of patients with irritable bowel syndrome using Chinese herbal granules and control samples (montmorillonite powder)

[0084] Total / cases Cured / case Significantly effective / case Valid / Example Invalid / Example Efficiency Montmorillonite powder 70 10 14 24 22 68.57% Embodiment 2 Chinese medicine granules 70 20 25 22 3 95.71% Embodiment 4 Chinese medicine granules 70 23 26 19 2 97.14% Example 5 Chinese medicine granules 70 16 24 23 7 90%

[0085] The above results show that the number of cured cases, the number of effective cases and the effective rate of the Chinese medicine granules of the present invention are significantly higher than those of the control group. The results prove that the Chinese medicine composition provided by the present invention has a good therapeutic effect on patients with diarrhea-type spleen and kidney yang deficiency syndrome irritable bowel syndrome; in addition, by comparing Example 2, Example 4, and Example 5, it can be found that the clinical treatment effect of the Chinese medicine granules prepared in Example 2 and Example 4 is better than that in Example 5, and the effective rate and cure rate are higher, and the curative effect is better. It is considered that the improvement of the preparation method of the main drug component makes the effective ingredients of the drug more complete, increases the bioavailability of the drug, and significantly improves the therapeutic effect.

[0086] In order to prove that the above-mentioned Chinese herbal granules have stable therapeutic effects and can significantly reduce the recurrence rate, the patients in group 2 were followed up for one year, and no recurrence occurred in the patients in group 2 (except 2 ineffective cases). After two years of follow-up, 2 patients in group 2 relapsed, and the recurrence rate within two years was 2.94%.

[0087] 5. Typical case examples:

[0088] (1) Mr. Wang, born in 1978, from Changchun City, Jilin Province, went to Yingshi TCM Clinic in Nanguan District, Changchun for treatment in March 2019. For 3 years, the patient had loose stools, abdominal pain, pain relieved by warmth, soreness of waist and knees, pale and fat tongue with white fur, and weak pulse. After examination, he was diagnosed with irritable bowel syndrome. TCM diagnosis: diarrhea due to spleen and kidney yang deficiency. Oral administration of the Chinese medicine granules prepared in Example 4 of the present invention, 6 g each time, 3 times / d, for 1 course of treatment, diarrhea and abdominal pain were relieved, and after 6 courses of treatment, the clinical symptoms disappeared, and there was no recurrence until February 2021 of follow-up.

[0089] (2) Mr. Li, born in 1989, from Siping City, Jilin Province, went to Yingshi TCM Clinic in Nanguan District, Changchun for treatment in August 2016. For 6 months, the patient had diarrhea before dawn, abdominal pain, pain relieved by warmth, soreness of waist and knees, cold body and limbs, pale and fat tongue with white fur, and weak pulse. After examination, he was diagnosed with irritable bowel syndrome. TCM diagnosis: diarrhea due to spleen and kidney yang deficiency. He took the Chinese medicine granules of Example 4 of the present invention orally, 6g each time, 3 times / d, for 1 course of treatment, and diarrhea and abdominal pain were relieved. After 2 courses of treatment, the clinical symptoms disappeared, and there was no recurrence during follow-up until 2021.

[0090] (3) Mr. Liu, born in 1979, from Fuyu City, Jilin Province, went to the Third Clinical Affiliated Hospital of Changchun University of Chinese Medicine for treatment in July 2023. For 5 years, the patient had umbilical and abdominal pain before dawn, diarrhea with intestinal rumbling, pain relief with warmth, soreness of waist and knees, cold body and limbs, pale and fat tongue with white fur, and weak pulse. After examination, he was diagnosed with irritable bowel syndrome. Chinese medicine diagnosis: diarrhea due to spleen and kidney yang deficiency. Oral administration of the Chinese medicine granules of Example 4 of the present invention, 6g each time, 3 times / d, for 1 month of treatment, abdominal pain was relieved, and after 8 courses of treatment, clinical symptoms disappeared. Follow-up until 2024 did not recur.

[0091] (4) Ms. Zhang, born in 1985, from Yanji City, Jilin Province, visited Yingshi TCM Clinic in Nanguan District, Changchun City in September 2015. For 8 months, the patient had umbilical and abdominal pain before dawn, diarrhea with bowel sounds, occasional constipation, abdominal pain, pain relief with warmth, soreness of waist and knees, cold extremities, pale and fat tongue with white and slippery fur, and deep and weak pulse. After examination, she was diagnosed with irritable bowel syndrome. TCM diagnosis: diarrhea due to spleen and kidney yang deficiency. Oral administration of the Chinese medicine granules of the present invention, 6g each time, 3 times / d, for 1 course of treatment, abdominal pain was relieved, and after 3 courses of treatment, clinical symptoms disappeared. No recurrence was observed during follow-up until 2017.

[0092] (5) Ms. Wang, born in 1996, from Yingkou City, Liaoning Province, went to Yingshi Traditional Chinese Medicine Clinic in Zhanqian District, Yingkou City for treatment in March 2017. The patient had abdominal pain and diarrhea at dawn for 2 years, which was relieved by warmth, soreness of waist and knees, cold extremities, pale and fat tongue with white and slippery fur, and deep and weak pulse. After examination, she was diagnosed with irritable bowel syndrome. TCM diagnosis: diarrhea due to spleen and kidney yang deficiency. Oral administration of the Chinese medicine granules of Example 4 of the present invention, 6g each time, 3 times / d. After 1 course of treatment, the abdominal pain was relieved, and after 4 courses of treatment, the clinical symptoms disappeared. Follow-up until 2021 did not recur.

[0093] It should be noted that the Chinese medicine composition provided by the present invention was developed by Professor Ying Dashi based on many years of clinical experience. Professor Ying Dashi is an expert at the Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine and is also the fourth-generation inheritor of Ying's Traditional Chinese Medicine. Therefore, the above-mentioned Chinese medicine granules are used in the Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine and Ying's Traditional Chinese Medicine Clinic. The above is only part of the clinical data of the Chinese medicine granules of the present invention.

[0094] The above description is a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating diarrhea-type IBS due to spleen and kidney yang deficiency, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 6-12 ginseng, 5-15 julibrissin flowers, 5-15 fructus aurantii, 8-15 atractylodes, 8-15 atractylodes, 2-5 pilose antlers, 2-6 evodia rutaecarpa, 3-9 cordyceps, 15-20 heartwood soil, 8-15 red ochre, 3-10 terminalia chebula, and 5-9 roasted liquorice.

2. A Chinese medicine composition for treating diarrhea-type spleen and kidney yang deficiency IBS according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 10-12 parts of ginseng, 12-15 parts of julibrissin flowers, 9-15 parts of fructus aurantii, 10-15 parts of atractylodes, 10-15 parts of atractylodes, 10-15 parts of atractylodes, 3-5 parts of pilose antler, 4-6 parts of evodia rutaecarpa, 5-9 parts of cordyceps, 17-20 parts of heartwood soil, 10-15 parts of red ochre, 5-10 parts of terminalia chebula, and 6-9 parts of roasted liquorice.

3. A Chinese medicine composition for treating diarrhea-type spleen and kidney yang deficiency IBS according to claim 2, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 10-12 parts of ginseng, 12-15 parts of julibrissin flowers, 12-15 parts of fructus aurantii, 13-15 parts of atractylodes, 13-15 parts of atractylodes, 4-5 parts of pilose antler, 5-6 parts of evodia rutaecarpa, 7-9 parts of cordyceps, 19-20 parts of heartwood soil, 13-15 parts of red ochre, 7-10 parts of terminalia chebula, and 8-9 parts of roasted liquorice.

4. Use of the Chinese medicine composition for treating diarrhea-type IBS with spleen-kidney yang deficiency according to claim 1, 2 or 3 in the preparation of a medicament for treating diarrhea-type IBS with spleen-kidney yang deficiency.

5. The use according to claim 4, characterized in that: The dosage form of the drug for treating diarrhea-type IBS with spleen and kidney yang deficiency is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, oral liquids or pills.

6. A Chinese medicine granule for treating diarrhea-type IBS with spleen and kidney yang deficiency syndrome, comprising a main drug component and auxiliary materials; characterized in that: The main drug component is obtained by processing the Chinese medicine composition for treating diarrhea-type spleen and kidney yang deficiency syndrome IBS according to claim 1, 2 or 3 as a raw material.

7. The Chinese medicine granules for treating diarrhea-type spleen and kidney yang deficiency IBS according to claim 6, characterized in that: The preparation method of the main drug component comprises the following steps: Ginseng is crushed, passed through an 80-100 mesh sieve, and crushed with an ultrafine grinder to an average particle size of less than 2 microns to obtain ultrafine ginseng powder for later use; Albizzia julibrissin, add water and boil for 1-3 times, each time for 1-2 hours, filter, combine the filtrate, concentrate to an extract with a relative density of 1.08-1.12 at 60°C, add ethanol and stir until the alcohol content reaches 60%, let stand, filter, take the supernatant and concentrate to an extract with a relative density of 1.20-1.25 at 60°C, dry under reduced pressure, take the dry extract and grind it into fine powder for later use; Add water to fructus aurantii, terminalia chebula, red ochre and heartwood, and boil for 1-3 times, each time for 15-60 minutes, filter, combine the filtrate, and concentrate the filtrate to an extract with a relative density of 1.0-1.3 at 70°C, and set aside; Add water to white atractylodes, atractylodes and licorice, and boil for 1-3 times, each time for 15-30 minutes. Combine the decoctions, filter them, and concentrate them into a clear paste with a relative density of 1.04-1.06 at 60°C for later use. The antlers are crushed and passed through a 30-mesh sieve to obtain antler powder; the antler powder is then soaked in an entrainer for 1 hour and then put into an extraction kettle, wherein the entrainer is 75% ethanol; the SFE supercritical fluid preparation system is heated, and when the temperature reaches 50°C and the pressure reaches 30 MPa, dynamic extraction is performed for 3 hours, the material is connected from the outlet valve, and the entrainer is removed by vacuum decompression and drying to obtain antler extract for standby use; Evodia rutaecarpa, add water and decoct for 1-3 times, soak for 1-2 hours before the first decoction, and decoct for 1-2 hours each time; filter, combine the filtrate, concentrate to an extract with a relative density of 1.33 at 60°C, vacuum dry to obtain extract powder, and set aside; Soak Cordyceps sinensis for 1.5 hours, crush the Cordyceps sinensis fruiting body, pass through an 80-mesh sieve and add it into a supercritical CO2 extraction cell; the parameters are set as follows: pressure 20Mpa; extraction cell temperature 50℃, desorption temperature 40℃; static extraction 10min, dynamic extraction 75min; CO2 flow rate 1.0L / min, and obtain a yellow transparent oily substance for standby use; The main medicinal ingredients are prepared by mixing ultrafine ginseng powder, fine powder of julibrissin flower, extracts of fructus aurantii, chebula chebula, red ochre and hearth soil, clear pastes of atractylodes macrocephala, atractylodes lancea and licorice root, deer antler extract, extract powder of evodia rutaecarpa and cordyceps sinensis oil, drying under reduced pressure and grinding into fine powder.