A traditional Chinese medicine composition for treating functional dyspepsia in children, a preparation method and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine composition for treating children's functional dyspepsia, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: Fructus Aurantii Immaturus 5-20 parts, Magnolia officinalis 5-20 parts, Forsythia suspensa 5-30 parts, Dendrobium 5-30 parts, Atractylodes macrocephala 5-20 parts, and Glycyrrhiza 5-30 parts. The pharmacological experiment results show that the traditional Chinese medicine composition has the effects of improving gastrointestinal motility and regulating gastrointestinal hormone secretion, has a significant therapeutic effect on children's functional dyspepsia, has stable curative effect, and has a small dosage. Meanwhile, the present application has the advantages of simple process operation, low cost, good controllability and stability, and is suitable for industrialized mass production.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology and relates to a traditional Chinese medicine composition for treating functional dyspepsia in children, its preparation method, and its application. Background Technology

[0002] Functional gastrointestinal disorders (FGIDs) are common in children of all ages. FGIDs are a collective term for a range of symptoms affecting gastrointestinal function. Currently, there are no clear biochemical markers available to monitor the progression of these disorders, and their exact pathological mechanisms are not fully understood. Clinical features include upper abdominal pain, burning sensation, postprandial fullness, or early satiety. Functional dyspepsia (FD) is a subgroup of FGIDs and belongs to a clinical syndrome encompassing chronic symptoms originating in the stomach and duodenum.

[0003] Functional dyspepsia in children may be accompanied by symptoms such as loss of appetite, belching, nausea, or vomiting. These symptoms originate in the upper abdomen, and blood biochemistry and endoscopic examinations show no abnormalities. The clinical manifestations are difficult to explain by organic disease. The disease course is long, often leading to insufficient nutrient intake, affecting children's physical and mental health and intellectual development, and seriously impacting their lives and learning.

[0004] There are no ancient records of functional dyspepsia in traditional Chinese medicine. Based on its clinical manifestations and characteristics such as poor appetite, abdominal distension, or abdominal pain, the "Expert Consensus on Diagnosis and Treatment (2022)" classifies childhood functional dyspepsia under the categories of "infantile food stagnation," "stomach pain," and "abdominal distension" in traditional Chinese medicine. However, the understanding of "abdominal distension" and "infantile food stagnation" by physicians throughout history has not been entirely the same. They attribute its pathogenesis to the fact that children's five internal organs are not fully developed, and even when fully developed, they are not strong enough. The spleen is often deficient, and the spleen and stomach are inherently weak. Improper feeding can easily damage the spleen and stomach, causing food to stagnate in the epigastrium, accumulate undigested, and lead to qi stagnation and disease. Spleen deficiency and qi stagnation, and stomach disharmony are the basic pathogenesis of FD. Modern physicians classify functional dyspepsia into syndromes such as "food stagnation," "spleen deficiency and food stagnation," "spleen and stomach damp-heat," "liver and stomach disharmony," "spleen and stomach deficiency and cold," and "mixed cold and heat." However, children's yin and yang are immature, and their growth and development are rapid, often resulting in a relative deficiency of yin essence. In addition, children are prone to febrile diseases, which easily damage body fluids and deplete spleen yin. Furthermore, changes in the dietary structure and lifestyle of modern children, such as staying up late to catch up on their studies and consuming fried, spicy, and rich foods, can generate internal heat over time, damaging the yin of the body and injuring the yin of the spleen and stomach. This leads to functional dyspepsia due to spleen and stomach yin deficiency, which is a common clinical syndrome in children.

[0005] Traditional Chinese medicine clinical practice often adopts the treatment principles of promoting digestion, strengthening the spleen and stomach, regulating qi and eliminating dampness, and harmonizing the stomach and purging the intestines when prescribing medicines. For example, Zhishu granules (strengthening the spleen and promoting digestion, regulating qi and eliminating dampness) and Xiangsha Zhishu pills (strengthening the spleen and stomach, regulating qi and eliminating stagnation) are mostly for patients with weak spleen and stomach and damp-heat accumulation. However, there is a lack of effective prescriptions for functional dyspepsia of the spleen and stomach yin deficiency type.

[0006] Due to the complexity of the pathophysiological mechanisms of functional dyspepsia (FD), modern clinical treatments often yield unsatisfactory results. Based on the unique theoretical understanding of Traditional Chinese Medicine (TCM), current TCM clinical prescriptions are mostly decoctions. Furthermore, current decoctions for treating functional dyspepsia in children still suffer from large dosages, numerous ingredients, poor taste, and low clinical compliance, failing to meet the needs of children for smaller dosages, more noticeable effects, better taste, and safety without toxic side effects. Therefore, the research and development of modern TCM formulas and preparations using traditional Chinese medicinal materials that are both food and medicine, specifically targeting spleen and stomach yin deficiency, has become an urgent problem to be solved.

[0007] This invention develops a traditional Chinese medicine preparation that is easy to carry, has controllable quality, stable efficacy, easy to industrialize, and is safe and free of toxic side effects, making it particularly suitable for children to take, in order to meet the clinical development needs of children with functional dyspepsia. Summary of the Invention

[0008] The purpose of this invention is to overcome the above-mentioned shortcomings and provide a traditional Chinese medicine composition derived from medicinal and edible herbs for treating functional dyspepsia in children with spleen and stomach yin deficiency. This composition is more suitable for clinical pediatric use, with mild, safe and effective properties, stable and controllable effects, small dosage, sweet taste and good clinical compliance.

[0009] Another object of the present invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition for treating functional dyspepsia in children.

[0010] Another objective of this invention is to provide the application of the above-mentioned drug in the preparation of a treatment for functional dyspepsia in children, particularly for gastrointestinal diseases caused by poor appetite, hot flashes in the hands and feet, constipation, weak gastrointestinal motility, and gastrointestinal dysfunction.

[0011] To achieve the above objectives, the present invention is implemented through the following technical solutions.

[0012] A traditional Chinese medicine composition for treating functional dyspepsia, prepared from the following raw materials in parts by weight: 5-20 parts of Citrus aurantium, 5-20 parts of Magnolia officinalis, 5-30 parts of Forsythia suspensa, 5-30 parts of Dendrobium nobile, 5-20 parts of Atractylodes macrocephala, and 5-30 parts of Glycyrrhiza uralensis; preferably prepared from the following raw materials in parts by weight: 10-15 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 10-15 parts of Forsythia suspensa, 10-15 parts of Dendrobium nobile, 10-15 parts of Atractylodes macrocephala, and 10-15 parts of Glycyrrhiza uralensis; most preferably 15 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 10 parts of Forsythia suspensa, 10 parts of Dendrobium nobile, 15 parts of Atractylodes macrocephala, and 15 parts of Glycyrrhiza uralensis. The above composition is further prepared by adding pharmaceutically acceptable excipients to obtain an oral formulation; preferably, the oral formulation is granules, oral liquid, or tablets.

[0013] The preparation method of the above-mentioned traditional Chinese medicine composition includes:

[0014] (1) Extract the medicinal herbs other than Dendrobium and Atractylodes macrocephala with water or ethanol aqueous solution to obtain crude extract. Elute the crude extract through a macroporous resin column or polyamide resin column to obtain eluent. Concentrate and dry the eluent to obtain extract A.

[0015] (2) Take Dendrobium and Atractylodes macrocephala, extract with water, concentrate the extract under reduced pressure, precipitate with alcohol, and dry to obtain extract B;

[0016] (3) Mix A and B.

[0017] When using a macroporous resin column for elution and purification in step (1), the macroporous resin is of type AB-8, D101, HPD100, DM301, HPD300, HPD500 or HPD600, preferably type AB-8, HPD300 or D101, and most preferably type HPD300.

[0018] When using a macroporous resin column for purification, the concentration of the loading solution is 1–3 g / mL based on the amount of crude drug, the adsorption flow rate is 1–5 BV / h, the resin column diameter-to-height ratio is 1:4–15, and the resin is eluted with 2–8 column volumes of water to remove impurities. Then, 2–15 resin volumes are eluted with 30–90% v / v ethanol as the eluent at a flow rate of 1–4 BV / h. Preferably, the eluent used is 30–75% v / v ethanol, and most preferably, 50–60% v / v ethanol is used.

[0019] The preferred resin column diameter-to-height ratio is 1:8-10, the adsorption flow rate is 1-2 BV / h, and the elution flow rate is 2-3 BV / h.

[0020] It is preferred to use 4-5 BV water to wash the resin for impurity removal.

[0021] The resin is preferably eluted with 5-6 BV ethanol.

[0022] When using a polyamide resin column for elution and purification in step (1), the concentration of the loading solution is 1-2.5 g / mL based on the amount of raw drug, the adsorption flow rate is 1-5 BV / h, the resin column diameter-to-height ratio is 1:6-8, and water is used to wash 2-6 times the resin volume for impurity removal. 30-75% v / v ethanol is used as the eluent to wash 3-8 times the resin volume, and the elution flow rate is 1-4 BV / h.

[0023] In the preferred step (1), 60-70% v / v ethanol is used to extract the medicinal materials other than Dendrobium and Atractylodes macrocephala. The extraction is performed 2-3 times, and the amount of ethanol used each time is 8-12 times that of the medicinal materials. The extracts are combined and filtered. The filtrate is concentrated under reduced pressure until there is no alcohol taste to obtain the crude extract.

[0024] In the preferred step (2), Dendrobium and Atractylodes macrocephala are extracted twice, each time for 1 to 1.5 hours, with 8 to 10 times the weight of the medicinal materials in water each time. The extracts are combined, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.20 to 1.25. It is then precipitated with 95% v / v alcohol to a concentration of 70 to 80%, left to stand overnight, filtered, and the filtrate is concentrated under reduced pressure, dried, and pulverized to obtain the extract.

[0025] The aforementioned traditional Chinese medicine composition has shown significant efficacy in the preparation of drugs for treating functional dyspepsia in children.

[0026] This invention utilizes Dendrobium, Citrus aurantium, and Magnolia officinalis, all commonly used clinical medicinal materials. Dendrobium, in particular, is sweet and slightly cold in nature, possessing the effects of nourishing yin, clearing heat, and promoting fluid production to quench thirst. It nourishes the yin of the spleen and stomach, replenishing insufficient yin fluid caused by yin deficiency, thereby improving symptoms of spleen and stomach yin deficiency. Citrus aurantium is bitter, pungent, sour, and slightly cold in nature, entering the spleen and stomach meridians. It effectively breaks up qi stagnation, resolves phlegm, and promotes the normal ascending and descending of the spleen and stomach, thus improving symptoms of indigestion. Magnolia officinalis is pungent and warm in nature, entering the spleen, stomach, lung, and large intestine meridians. It is a key medicine for treating abdominal distension caused by dampness obstructing food stagnation and qi stagnation. It harmonizes qi, promotes the digestive function of the spleen and stomach, and eliminates fullness and discomfort in the spleen and stomach. Atractylodes macrocephala is sweet and warm, tonifying the middle jiao, replenishing the spleen and drying dampness, benefiting qi and generating blood. It strengthens the spleen and stomach, improving their digestive capacity, thereby improving symptoms of spleen and stomach weakness caused by yin deficiency. Forsythia has a bitter and cold nature and has the effects of clearing heat and detoxifying, dispersing nodules and reducing swelling.

[0027] In this formula, Forsythia suspensa is mainly used to clear heat from the spleen and stomach, alleviate the upward flaring of deficiency fire caused by yin deficiency, and also help improve stomach heat symptoms caused by indigestion. Licorice has the effects of tonifying the spleen and replenishing qi, and harmonizing the effects of other herbs. In this formula, licorice can both enhance the spleen-strengthening effect of Atractylodes macrocephala and harmonize the qi-regulating effects of Citrus aurantium and Magnolia officinalis, making the overall medicinal properties of the formula more balanced. The entire formula works synergistically to strengthen the spleen and stomach, nourish yin and generate fluids. It closely matches the pathogenesis of spleen and stomach yin deficiency caused by accumulated heat in the gastrointestinal tract, damage to yin, and injury to the spleen and stomach. The formula is based on sound principles and the medicine is well-matched to the symptoms, making it an effective formula for treating functional dyspepsia in children, as discovered in this invention.

[0028] The advantages of this invention compared with the prior art are as follows:

[0029] The pharmaceutical composition of this invention comprises six ingredients: Fructus Aurantii Immaturus, Fructus Forsythiae, Cortex Magnoliae Officinalis, Herba Dendrobii, Rhizoma Atractylodis Macrocephalae, and Radix Glycyrrhizae. This composition produces a synergistic effect, significantly enhancing efficacy and avoiding the potential differences in efficacy caused by simple drug mixing. While controlling intestinal inflammatory factors, it also improves gastrointestinal dysfunction and visceral hypersensitivity. Furthermore, the medicinal components are mild in nature and do not require highly cooling or heating ingredients such as rhubarb, making it particularly suitable for children.

[0030] Pharmacological experiments have shown that the herbal composition of this invention has a good effect on improving gastrointestinal motility and regulating the secretion of gastrointestinal hormones, and has a significant therapeutic effect on functional dyspepsia in children. The efficacy is stable and the dosage is small. At the same time, the process of this invention is simple to operate, low in cost, and has good controllability and stability, making it suitable for large-scale industrial production. Detailed Implementation

[0031] The present invention will be further described in detail below with reference to specific embodiments. The embodiments given are only for illustrating the present invention and are not intended to limit the scope of the present invention.

[0032] Example 1:

[0033] Weigh the raw materials according to the following weight ratios:

[0034] 15 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 10 parts of Forsythia suspensa, 10 parts of Dendrobium nobile, 15 parts of Atractylodes macrocephala, and 15 parts of Glycyrrhiza uralensis.

[0035] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 10 times the amount of water, heat and extract 3 times, 1.5 hours each time, combine the water extracts, filter, combine the filtrates, concentrate under reduced pressure, concentrate to the concentration of the herb solution 1.0 g / mL (based on the amount of raw herbs), and adsorb onto 5 L of wet HPD300 macroporous resin (resin diameter-to-height ratio 1:8) at an adsorption flow rate of 1.0 BV / h. First, elute with 4 BV of water, then elute with 6 BV of 50% v / v ethanol at an elution flow rate of 2 BV / h. Collect the 50% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain 390 g of extract A for later use;

[0036] Take Dendrobium and Atractylodes macrocephala, add 10 times the amount of water, heat and extract 3 times, each time using solvent for 1.0 hour, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.15, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 80%, let stand for 8 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry, pulverize, and obtain Dendrobium compound extract B 780g;

[0037] (2) Take the above extracts A and B, mix them, pass them through an 80-mesh sieve, add an appropriate amount of sugar powder, mannitol, povidone K30 and citric acid to granulate, package them and you will get granules.

[0038] Example 2:

[0039] Weigh the raw materials according to the following weight ratios:

[0040] 20 parts of Citrus aurantium, 20 parts of Magnolia officinalis, 20 parts of Forsythia suspensa, 5 parts of Dendrobium nobile, 5 parts of Atractylodes macrocephala, and 5 parts of Glycyrrhiza uralensis.

[0041] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 12 times the amount of water, heat and extract twice, 2 hours each time, combine the water extracts, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.20, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 75%, let stand for 12 h, filter, concentrate under reduced pressure until there is no alcohol taste, dilute with water to a sample solution concentration of 1.5 g / mL (based on the amount of raw herbs), adsorb on 10 L of wet D101 macroporous resin (resin diameter-to-height ratio 1:10), adsorption flow rate 2.0 BV / h, first elute with 3 BV of water, then elute with 5 BV of 60% v / v ethanol, elution flow rate 3 BV / h, collect the 60% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain extract A 365 g.

[0042] Take Dendrobium and Atractylodes macrocephala, add 15 times the amount of water, heat and extract twice, each time for 2.0 hours, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.15, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 50%, let stand for 12 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain extract B 210g, for later use;

[0043] (2) Take the above extracts A and B, mix them, pass them through an 80-mesh sieve, add appropriate amounts of sodium carboxymethyl cellulose, glyceryl oleate, sucrose, flavoring and sorbitol, mix well, make into granules, dry, granulate, and then prepare dry suspension according to conventional process.

[0044] Example 3:

[0045] Weigh the raw materials according to the following weight ratios:

[0046] 10 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 15 parts of Forsythia suspensa, 15 parts of Dendrobium nobile, 5 parts of Atractylodes macrocephala, and 10 parts of Glycyrrhiza uralensis.

[0047] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 10 times the amount of 30% ethanol, heat and extract 3 times, 1.0 hour each time, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.20, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 75%, let stand for 24 hours, filter, concentrate under reduced pressure until there is no alcohol taste, dilute with water to a sample solution concentration of 2.5 g / mL (based on the amount of raw herbs), adsorb on 5 L of wet AB-8 macroporous resin (resin diameter-to-height ratio 1:12), adsorption flow rate 2.0 BV / h, first elute with 4 BV of water, then elute with 8 BV of 50% v / v ethanol, elution flow rate 1.5 BV / h, collect the 50% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain dry powder extract A 395 g;

[0048] Take Dendrobium and Atractylodes macrocephala, add 8 times the amount of water, heat and extract twice, each time for 1.5 hours, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.25, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 60%, let stand for 18 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain extract B 440g;

[0049] (2) Take the above extracts A and B, mix them, pass them through an 80-mesh sieve, add appropriate amounts of sucralose, lactose, and dextrin, and granulate to obtain granules.

[0050] Example 4:

[0051] Weigh the raw materials according to the following weight ratios:

[0052] 20 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 20 parts of Forsythia suspensa, 20 parts of Dendrobium nobile, 5 parts of Atractylodes macrocephala, and 5 parts of Glycyrrhiza uralensis.

[0053] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 8 times the amount of 50% ethanol, heat and extract twice, 1.5 hours each time, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.25, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 80%, let stand for 24 h, filter, concentrate under reduced pressure until there is no alcohol taste, add water to dilute to the sample solution concentration of 3.5 g / mL (based on the amount of raw herbs), and adsorb on a 10 L wet polyamide column (resin diameter to height ratio 1:8), adsorption flow rate 3.0 BV / h, first elute with 4 BV water, then elute with 8 BV 70% v / v ethanol, elution flow rate 2 BV / h, collect the 70% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain extract A 385 g;

[0054] Take Dendrobium and Atractylodes macrocephala, add 10 times the amount of water, heat and extract 3 times, 1.5 hours each time, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.20, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 70%, let stand for 12 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain extract B410g, for later use;

[0055] (2) Take the above extracts A and B, mix them, pass them through a 100-mesh sieve, add lactose, mannitol, microcrystalline cellulose, aspartame, and citric acid as needed, mix well, make granules, dry, add an appropriate amount of magnesium stearate, compress into tablets, and obtain tablets.

[0056] Example 5:

[0057] Weigh the raw materials according to the following weight ratios:

[0058] 10 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 15 parts of Forsythia suspensa, 15 parts of Dendrobium nobile, 10 parts of Atractylodes macrocephala, and 10 parts of Glycyrrhiza uralensis.

[0059] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 10 times the amount of 85% ethanol, heat and extract twice, 1.0 hour each time, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure until there is no alcohol taste, dilute with water to the concentration of the sample solution 1.5 g / mL (based on the amount of raw herbs), and adsorb onto 3.5 L of wet D101 macroporous resin (resin diameter to height ratio 1:12), adsorption flow rate 4 BV / h, first elute with 6 BV of water, then elute with 3 BV of 80% v / v ethanol, elution flow rate 1 BV / h, collect the 80% v / v ethanol eluent, recover the ethanol, concentrate, dry, pulverize, and obtain extract A 328 g for later use;

[0060] Take Dendrobium and Atractylodes macrocephala, add 12 times the amount of water, heat and extract twice, using solvent for 2 hours each time, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.15, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 70%, let stand for 10 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain extract B458g, for later use;

[0061] (2) Take the above extracts A and B, mix them, pass them through a 100-mesh sieve, add appropriate amounts of dextrin, lactose, citric acid, sodium saccharin, strawberry flavor, and sodium carboxymethyl starch, mix well, make granules, dry, and granulate to obtain granules.

[0062] Example 6:

[0063] Weigh the raw materials according to the following weight ratios:

[0064] 5 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 10 parts of Forsythia suspensa, 15 parts of Dendrobium nobile, 10 parts of Atractylodes macrocephala, and 15 parts of Glycyrrhiza uralensis.

[0065] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 10 times the amount of 65% ethanol, heat and extract twice, each time for 1.5 hours, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure until there is no alcohol taste, dilute with water to the sample solution concentration of 2.5 g / mL (based on the amount of raw herbs), and adsorb onto 10 L of wet HPD100 macroporous resin (resin diameter to height ratio 1:4) at an adsorption flow rate of 1.5 BV / h. First, elute with 5 BV of water, then elute with 4 BV of 70% v / v ethanol at an elution flow rate of 1 BV / h. Collect the 70% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain dry powder extract A357 g;

[0066] Take Dendrobium and Atractylodes macrocephala, add 6 times the amount of water, heat and extract 3 times, using solvent for 1 hour each time, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.10, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 40%, let stand for 10 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain extract B320g, for later use.

[0067] (2) Take the above extracts A and B, mix them, pass them through an 80-mesh sieve, add microcrystalline cellulose, aspartame, citric acid, and an appropriate amount of sodium carboxymethyl starch, mix well, make granules, dry, dry granulate, add an appropriate amount of micronized silica gel and magnesium stearate, compress into tablets, and obtain tablets.

[0068] Example 7:

[0069] Weigh the raw materials according to the following weight ratios:

[0070] 10 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 15 parts of Forsythia suspensa, 15 parts of Dendrobium nobile, 10 parts of Atractylodes macrocephala, and 15 parts of Glycyrrhiza uralensis.

[0071] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 10 times the amount of 60% ethanol, heat and extract 3 times, 1.5 hours each time, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure until there is no alcohol taste, dilute with water to the sample solution concentration of 2 g / mL (based on the amount of raw herbs), and adsorb onto 4.5 L of wet HPD600 macroporous resin (resin diameter to height ratio 1:10), adsorption flow rate 2 BV / h, first elute with 3 BV of water, then elute with 5 BV of 75% v / v ethanol, elution flow rate 2 BV / h, collect the 75% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain extract A 350 g for later use;

[0072] Take Dendrobium and Atractylodes macrocephala, add 8 times the amount of water, heat and extract twice, using solvent for 1.5 hours each time, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.10, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 60%, let stand for 10 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain extract B240g, for later use;

[0073] (2) Take the above dry powder extracts A and B, mix them, pass them through a 100-mesh sieve, add stevia, citric acid and lactose as needed, mix well, granulate with 95% ethanol, dry, and obtain granules.

[0074] Example 8:

[0075] Weigh the raw materials according to the following weight ratios:

[0076] 10 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 15 parts of Forsythia suspensa, 10 parts of Dendrobium nobile, 15 parts of Atractylodes macrocephala, and 10 parts of Glycyrrhiza uralensis.

[0077] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 12 times the amount of 60% ethanol, heat and extract 3 times, 2.0 hours each time, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure until there is no alcohol taste, dilute with water to the concentration of the sample solution 1.5 g / mL (based on the amount of raw herbs), and adsorb on 5 L of wet HPD300 macroporous resin (resin diameter to height ratio 1:6) at an adsorption flow rate of 2 BV / h. First, elute with 2 BV of water, then elute with 4 BV of 60% v / v ethanol at an elution flow rate of 2 BV / h. Collect the 60% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain 410 g of extract;

[0078] Take Dendrobium and Atractylodes macrocephala, add 8 times the amount of water, heat and extract 3 times, each time for 2 hours, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.30, add 95% ethanol for alcohol precipitation, precipitate until the ethanol content is 50%, let stand for 12 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry to obtain 278g of extract for later use.

[0079] (2) Take the above extracts A and B, mix them together, add sodium carboxymethyl cellulose, sucrose, citric acid, and an appropriate amount of mannitol, dissolve them in purified water, filter, sterilize, and you will get the oral liquid.

[0080] Example 9

[0081] Weigh the raw materials according to the following weight ratios:

[0082] 10 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 15 parts of Forsythia suspensa, 15 parts of Dendrobium nobile, 10 parts of Atractylodes macrocephala, and 5 parts of Glycyrrhiza uralensis.

[0083] (1) Weigh 10 kg of the above-mentioned herbs, except for Dendrobium and Atractylodes macrocephala, add 10 times the amount of 50% ethanol, heat and extract 3 times, 1.0 hour each time, combine the extracts, filter, combine the filtrates, heat and extract 3 times, 2.0 hours each time, combine the extracts, filter, combine the filtrates, concentrate under reduced pressure until there is no alcohol taste, dilute with water to the sample solution concentration of 2 g / mL (based on the amount of raw herbs), and adsorb onto 8 L of wet HPD100 macroporous resin (resin diameter to height ratio 1:8), adsorption flow rate 2 BV / h, first elute with 5 BV of water, then elute with 50% v / v ethanol 5 BV, elution flow rate 2 BV / h, collect the 50% v / v ethanol eluent, recover the ethanol, dry under reduced pressure, pulverize, and obtain extract A 515 g;

[0084] Take Dendrobium and Atractylodes macrocephala, add 10 times the amount of water, heat and extract twice, each time for 1.0 hour, filter, combine the filtrates, concentrate under reduced pressure to a relative density of 1.20, add 95% v / v ethanol for alcohol precipitation, precipitate until the ethanol content is 60%, let stand for 10 hours, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry, pulverize, and obtain extract B 402g for later use;

[0085] (2) Take the above extracts A and B, mix them together, add appropriate amounts of microcrystalline cellulose, mannitol, hydroxypropyl methylcellulose and citric acid, mix evenly and pass through an 80-mesh sieve, use povidone K30 as a binder to granulate, pass through a 20-mesh sieve to granulate, then add lubricant, compress into tablets to obtain tablets.

[0086] Experimental Example 1

[0087] This formula contains six herbs, with *Citrus aurantium* and *Magnolia officinalis* serving as the principal herbs for regulating qi, relieving bloating, and harmonizing the stomach. *Forsythia suspensa*, *Dendrobium nobile*, and *Atractylodes macrocephala* serve as the assistant herbs. *Citrus aurantium* and *Glycyrrhiza uralensis* primarily contain flavonoids as their active substances, while *Magnolia officinalis* and *Forsythia suspensa* primarily contain lignans. The remaining two herbs, *Dendrobium nobile* and *Atractylodes macrocephala*, primarily contain alkaloids, and *Atractylodes macrocephala* primarily contains atractylenolides. Based on the physicochemical properties of the main chemical components of the herbs in the formula, the transfer rates of the indicator components, total flavonoids and total atractylenolides, were measured. Combined with the results of pharmacological experiments (with laxative effect as the evaluation indicator), the conventional water extraction method (process 1), water extraction and alcohol precipitation method (process 2), alcohol extraction method (process 3), and the extraction process of this invention (process 4) were compared to select the optimal preparation process.

[0088] The prescription used consists of the following ingredients: 67.5g of Citrus aurantium, 45g of Magnolia officinalis, 45g of Forsythia suspensa, 45g of Dendrobium nobile, 67.5g of Atractylodes macrocephala, and 67.5g of Glycyrrhiza uralensis.

[0089] in:

[0090] 1. Conventional water extraction method:

[0091] Weigh out the above-mentioned medicinal materials according to the prescription, excluding Magnolia officinalis and Dendrobium nobile. Add 12 times the amount of water and decoct for 2 hours. Filter the decoction. Add Magnolia officinalis and Dendrobium nobile to the residue and continue to decoct twice, each time for 1 hour. Add 10 and 8 times the amount of water respectively. Filter the decoction and combine the decoctions. Concentrate the filtrate under reduced pressure to a thick paste, dry under reduced pressure, and pulverize to obtain 118g of dry powder.

[0092] 2. Water extraction and alcohol precipitation method:

[0093] Weigh the above-mentioned medicinal materials according to the prescription, excluding Magnolia officinalis and Dendrobium nobile. Add 12 times the amount of water and decoct for 2 hours. Filter. Add Magnolia officinalis and Dendrobium nobile to the residue, add water and continue to decoct twice, each time for 1 hour. Add 10 and 8 times the amount of water respectively. Filter. Combine the decoctions and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.15-1.20. Add 95% ethanol to precipitate until the alcohol concentration is 75%. Let stand overnight, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste. Dry under reduced pressure and pulverize to obtain 77.7g of dry powder.

[0094] 3. Alcohol extraction process:

[0095] Weigh the above-mentioned medicinal materials according to the prescription, and extract them three times by reflux with 70% ethanol. The first extraction lasts for 2 hours, and the second and third extractions last for 1 hour each. The amounts of ethanol added are 12, 10, and 8 times respectively. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste. Dry under reduced pressure, pulverize, and obtain 113.5g of dry powder.

[0096] 4. Extraction process of this invention:

[0097] Weigh the above-mentioned medicinal materials according to the prescription. Except for Dendrobium and Atractylodes macrocephala, extract three times by reflux with 70% v / v ethanol. The first extraction is for 2 hours, and the second and third extractions are for 1 hour each. The amount of ethanol added is 12, 10, and 8 times the weight respectively. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure until there is no alcohol odor to obtain a crude extract. Purify the crude extract using a macroporous resin HPD300 under the same purification conditions as in Example 1 to prepare a refined extract of Citrus aurantium compound. Dry under reduced pressure to obtain 33g of dry powder A. Take Dendrobium and Atractylodes macrocephala, decoct them twice with water, each time for 1 hour, and add 10 and 8 times the weight of water respectively. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.20-1.25. Add 95% ethanol to precipitate the ethanol to a concentration of 70%, let stand overnight, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry under reduced pressure, and pulverize to obtain 23.5g of dry powder B. Mix the dry powder B with A evenly to obtain 56.5g of dry powder.

[0098] Total flavonoid transfer rate test of samples from different extraction processes in this invention:

[0099] The total flavonoids, total atractylodes lactones, and extract yield of each process were determined, and the extraction effects of different processes were compared. The results are shown in Table 1.

[0100] Table 1. Results of total flavonoid content and extract yield for each process.

[0101] Total flavonoid transfer rate % Total Atractylodes macrocephala fat transfer rate % Ointment yield % Process 1 82.5 70.1 34.9 Process 2 73.4 65.5 23.0 Process 3 95.2 75.7 33.6 Process 4 92.5 72.6 16.7

[0102] The results in Table 1 show that process 4 has the lowest extract yield, but higher extraction rates of total flavonoids and total atractylodes lactones. Therefore, process 4 is the best extraction process.

[0103] Experimental Example 2: Gastric emptying test of samples from different extraction processes in rats with spleen deficiency:

[0104] Healthy SD rats were randomly divided into 7 groups: normal control group, model control group, Qipi oral liquid 10ml / kg (equivalent to human clinical dose) dosage group, and conventional water extraction group (process 1), water extraction and alcohol precipitation group (process 2), alcohol extraction group (process 3), and extraction process group of the present invention (process 4) (all 2.7g crude drug / kg, equivalent to human clinical dose). Each group consisted of 12 rats, half male and half female.

[0105] Except for the blank group, each rat was administered rhubarb decoction (15 g / kg) by gavage for 7 consecutive days to establish a rat model of spleen deficiency. Except for the normal control group, all other groups were deprived of water but not food for 72 hours before being administered the corresponding drugs by gavage. The normal and model control groups were given an equal volume of distilled water, with a drug administration volume of 20 ml / kg. 60 minutes after drug administration, each group was administered 1.5 ml of 0.05% methylcellulose phenol red solution by gavage. The rats were sacrificed 15 minutes later, and their stomachs were immediately removed. The stomachs were thoroughly washed in 5 mL of sodium hydroxide solution (0.1 mol / L), centrifuged at 3500 r / min for 15 min, and the supernatant was collected. The absorbance was measured at 560 nm using an ELISA reader. The gastric absorbance values ​​for each group were calculated, and the results are shown in Table 2.

[0106] Table 2 Results of the rat gastric emptying test

[0107]

[0108] Note: Compared with the normal control group, ##P<0.01; compared with the model control group, **P<0.01

[0109] Table 2 shows that, compared with the normal control group, the gastric emptying rate of the model control group animals was significantly reduced, indicating successful model establishment. Compared with the model control group, the gastric emptying rate of rats in each process group and the Qipi oral liquid group was significantly increased. Pharmacological experimental results show that the extraction process of this invention is significantly different from other components, indicating that the process is optimal.

[0110] Experimental Example 2

[0111] The therapeutic activity of the traditional Chinese medicine composition of the present invention was demonstrated through experiments on the therapeutic effect of irregular feeding tail clamping stimulation on functional dyspepsia by designing different combinations and dosage samples:

[0112] 1. Test materials

[0113] 1.1 Medicines and Reagents

[0114] (1) The traditional Chinese medicine compound extract of the present invention: prepared according to the method in Example 1 of the present invention.

[0115] Preparation of Magnolia officinalis extract: Take 1 kg of Magnolia officinalis, add 70% ethanol and reflux for three extractions, the first time for 2 hours, the second and third times for 1 hour, the ethanol addition ratios are 12, 10 and 8 respectively, combine the decoctions, filter, concentrate the filtrate under reduced pressure until there is no alcohol odor to obtain crude extract, enrich it with macroporous resin HPD300 under the same enrichment conditions as in Example 1, prepare refined Magnolia officinalis extract, dry under reduced pressure to 72 g dry powder for later use.

[0116] Preparation of Citrus aurantium extract: Take 1 kg of Citrus aurantium and process it in the same way as the preparation method of Magnolia officinalis extract to obtain 336 g of dry powder for later use.

[0117] Preparation of licorice extract: Take 1 kg of licorice and process it in the same way as the preparation method of magnolia bark extract to obtain 205 g of dry powder for later use.

[0118] Preparation of Forsythia extract: Take 1 kg of Forsythia and process it in the same way as the preparation method of Magnolia officinalis extract to obtain 188 g of dry powder for later use.

[0119] Preparation of Atractylodes macrocephala extract: Take 1 kg of Atractylodes macrocephala, add water and decoct twice, each time for 1 hour, add 10 and 8 times the amount of water respectively, filter, combine the decoctions, filter again, concentrate the filtrate under reduced pressure to a relative density of 1.20, add 95% ethanol to precipitate until the alcohol concentration is 70%, let stand overnight, filter, recover the ethanol from the filtrate under reduced pressure and concentrate to a thick paste, dry under reduced pressure, pulverize to obtain 165 g of dry powder for later use.

[0120] Preparation of Dendrobium extract: Take 1 kg of Dendrobium and process it in the same way as the preparation method of Atractylodes macrocephala extract to obtain 136 g of dry powder for later use.

[0121] The extracts of the above-mentioned single medicinal materials were directly compounded and mixed according to the ratio of raw medicinal materials to obtain the following composition, as detailed below:

[0122] Composition 1: Fructus Aurantii Immaturus extract + Fructus Magnoliae Officinalis extract (crude herbs in a 1:1 weight ratio), mixed with dry powder to obtain...

[0123] Composition 2: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Radix Glycyrrhizae extract (raw medicinal materials in a weight ratio of 1:1:1)

[0124] Composition 3: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Radix Glycyrrhizae extract + Fructus Forsythiae (crude herbs in a weight ratio of 1:1:1:1)

[0125] Composition 4: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Radix Glycyrrhizae extract + Radix Forsythiae Sinensis extract + Radix Atractylodis Macrocephalae extract (crude herbs in a weight ratio of 1:1:1:1:1)

[0126] Composition 5: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Radix Glycyrrhizae extract + Radix Forsythiae Sinensis extract + Radix Atractylodis Macrocephalae extract + Radix Dendrobii extract (crude medicinal materials in a weight ratio of 1:1:1:1:1:1)

[0127] Composition 6: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Rhizoma Atractylodis Macrocephalae extract (crude herbs in a weight ratio of 1:1:1)

[0128] Composition 7: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Radix Glycyrrhizae extract + Radix Atractylodis Macrocephalae extract (crude herbs in a weight ratio of 1:1:1:1)

[0129] Composition 8: Fructus Aurantii Immaturus extract + Cortex Magnoliae Officinalis extract + Radix Glycyrrhizae extract + Radix Forsythiae Sinensis extract + Radix Dendrobii extract (crude medicinal materials in a weight ratio of 1:1:1:1:1)

[0130] (2) Positive control drug: Domperidone (Jiangxi Jiezhong Pharmaceutical Co., Ltd., approval number: H20033864): colorless transparent liquid, 10 mg / tablet, batch number: 201705007.

[0131] 1.2 Animals

[0132] SD rats: SPF grade, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd., license number: SCXK (Beijing) 2012-0001.

[0133] 2. Test methods and results

[0134] SD rats were selected, 28 days old, with a body weight of (60±10) g, half male and half female. Randomly select 10 rats as the normal control group, and the rest are the model group. The model was established at 32 days old, fed on odd days and fasted on even days. On the fasting days, the end of the 1 / 3 of the rat's tail was clamped with a long sponge forceps for stimulation. The stimulation time was 10 min / time, and the stimulation was repeated after an interval of 1 h and stopped after 4 h. The modeling was ended after 14 days, and the normal feeding was resumed. Randomly divided into 16 groups, 10 rats in each group, set as the model group, domperidone (3.5 mg / kg), single herbs of this formula and each composition group. Each group was given intragastric administration once a day, and the intragastric administration volume was 20 ml / kg body weight. The normal and model control groups were given an equal volume of distilled water by gavage. Administered continuously for 14 days. After the last gavage, the rats were fasted for 24 h. Randomly select 5 rats from each group, and give them a mixture of 5% activated carbon powder, milk and carboxymethylcellulose sodium water paste by gavage (weighing, W1). After 30 min, they were anesthetized and sacrificed. After quickly opening the abdominal cavity, the cardiac and pyloric of the stomach were ligated with medical silk thread. Blood was taken from the abdominal aorta with a vacuum blood collection tube, and the serum was separated and reserved. The stomach and small intestine were taken out, the stomach was weighed, the graphite powder in the stomach was washed clean with normal saline, and the surface moisture was blotted with filter paper and then weighed. Measure the distance from the pylorus to the leading edge of the carbon powder and the distance from the pylorus to the ileocecal part, and calculate the gastric emptying rate and small intestine propulsion rate of the rats respectively. The levels of MTL, CCK, and VIP in the serum of rats were measured by enzyme-linked immunosorbent assay to observe the effects of each composition of the present invention. The results are shown in Table 3 and Table 4.

[0135] Table 3 Test results of gastric emptying and small intestine propulsion rates of rats in different administration groups

[0136]

[0137]

[0138] Note: Compared with the normal control group: △△ P<0.01; compared with the model group, **P<0.01, *P<0.05

[0139] The above experimental results show that, compared with the normal control group, the gastric emptying rate and small intestinal propulsion rate of the model group were significantly reduced, indicating successful modeling. After 14 days of administration, both the composition of this invention and the positive control drug significantly increased the percentage of gastric emptying rate and small intestinal propulsion. Compared with the single extracts of Citrus aurantium and Magnolia officinalis, Composition 1 significantly increased the gastric emptying rate and small intestinal propulsion rate, indicating that the combination of Citrus aurantium and Magnolia officinalis has a synergistic effect. There was no significant difference in gastric emptying rate and small intestinal propulsion rate among Compositions 1, 2, and 3. However, compared with Composition 4, Composition 3 significantly increased the gastric emptying rate, indicating that Atractylodes macrocephala enhances the pharmacological activity of the combination of Citrus aurantium, Magnolia officinalis, Glycyrrhiza uralensis, and Forsythia suspensa. The addition of Dendrobium further enhances the pharmacological activity of the composition. The above results show that Composition 5 has the best effect.

[0140] Table 4. Results of serum MTL, VIP, and GAS levels in FD rats from different drug administration groups.

[0141]

[0142]

[0143] Note: Compared with the normal control group: △△P<0.01; compared with the model group: **P<0.01, *P<0.05.

[0144] The above experimental results indicate that MTL, GAS, and VIP levels were significantly different compared to the model group, indicating successful modeling. Compared to the model group, each drug administration group of this invention showed significant differences in all indicators. MTL (motilin) ​​primarily promotes gastric emptying; GAS (gastrin) is present in the gastric antrum and duodenum, stimulating gastric acid secretion, exhibiting gastric electrical rhythm, and promoting gastric emptying; VIP (vasoactive intestinal peptide) is widely distributed in nerve tissue and the gastrointestinal tract, inhibiting gastrointestinal motility, delaying gastric emptying, and slowing small intestinal motility; Magnolia officinalis enhances MTL secretion and weakens VIP secretion from Citrus aurantium. Compared to Citrus aurantium extract, Composition 1 showed a significantly increased MTL level and VIP level. The P level was significantly reduced; compared with composition 1, composition 2 showed a significant increase in GAS, indicating that Forsythia suspensa enhances gastrointestinal function; compared with composition 2, composition 3 showed a significant decrease in VIP level; there was no significant difference in effect between composition 4 and composition 3; compared with composition 2, composition 5 showed significant changes in GAS, MTL, and VIP, indicating that licorice, Atractylodes macrocephala, Dendrobium nobile, Citrus aurantium, Magnolia officinalis, and Forsythia suspensa have a synergistic effect, regulating gastrointestinal dysfunction by synergistically regulating gastrointestinal hormone secretion and promoting gastrointestinal motility, thereby improving FD gastrointestinal dysfunction. The above results show that composition 5 has the best effect.

[0145] To further optimize different formulation ratios, the activity of the herbal compound extract of this invention was evaluated using a mouse constipation model induced by compound diphenoxylate, as detailed below:

[0146] Healthy ICR mice, half male and half female, were randomly divided into a normal control group, a model control group, a group receiving 0.624 g contents / kg of hemp seed soft capsules, a group receiving process 4 from Example 1, a group receiving composition 5 from Example 2, and groups receiving samples from Examples 2, 3, 4, 7, and 8, all with a sample size of 0.25 g crude drug / kg. After fasting for 16 hours, all groups except the normal control group, which received 0.5% CMC-Na, received compound diphenoxylate 10 mg / kg at a volume of 20 ml / kg. 30 minutes later, each group received a carbon suspension containing the corresponding drug (containing 5% carbon powder and 10% gum arabic) at a volume of 20 ml / kg. Methylnaltrexone bromide was administered subcutaneously at a volume of 10 ml / kg, and simultaneously, an equal volume of carbon suspension was administered by gavage. The time of the first black stool and the number and weight of stools within 6 hours were recorded from the start of carbon administration. The results are shown in Table 4.

[0147] Table 4: Effects of compound diphenoxylate-induced constipation in mice

[0148]

[0149] Compared with the model group, *: p < 0.05 **: p < 0.01

[0150] Compound diphenoxylate acts directly on intestinal smooth muscle, reducing the peristaltic reflex of the local intestinal mucosa, weakening intestinal peristalsis, delaying the passage of intestinal contents, promoting intestinal water absorption, causing intestinal peristalsis inhibition, and leading to intestinal dysfunction. The above results show that, compared with the normal group, the model group had a delayed first defecation time and a significant decrease in the total number of fecal particles and total stool weight; compared with the model group, each treatment group had a significantly faster first defecation time and a significant increase in the total number of fecal particles and total stool weight; among the treatment groups, the four processing groups had the shortest first defecation time, the highest number of fecal particles, and the heaviest total stool weight, and the best pharmacological activity.

[0151] In summary, through extensive experimentation, the inventors discovered that adjusting the components of the aforementioned pharmaceutical composition significantly impacts the overall efficacy of the composition. The pharmaceutical composition of this invention contains Magnolia officinalis extract, Dendrobium officinale extract, and Glycyrrhiza uralensis extract, which exhibit synergistic effects in anti-inflammation, gastrointestinal motility, and gastrointestinal hormone secretion. The efficacy is significantly enhanced compared to using the same dosage of other herbal extracts (in the Fructus Aurantii Immaturus compound) alone, or using the same dosage of Magnolia officinalis extract, Dendrobium officinale extract, and Glycyrrhiza uralensis extract alone. Pharmacological tests have proven its significant therapeutic effect. While controlling intestinal inflammatory factors, it also improves intestinal dysfunction, thereby achieving the goal of treating functional dyspepsia in children.

Claims

1. A traditional Chinese medicine composition for treating functional dyspepsia in children, characterized in that... The composition was prepared from the following raw materials in parts by weight: 10-15 parts of Citrus aurantium, 10 parts of Magnolia officinalis, 10-15 parts of Forsythia suspensa, 10-15 parts of Dendrobium nobile, 10-15 parts of Atractylodes macrocephala, and 10-15 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating functional dyspepsia in children according to claim 1, characterized in that... The above composition was prepared by adding pharmaceutically acceptable excipients to obtain an oral formulation.

3. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method includes: (1) Extract the medicinal herbs other than Dendrobium and Atractylodes macrocephala with water or ethanol aqueous solution to obtain crude extract. Elute the crude extract with macroporous resin column or polyamide resin column to obtain eluent. Concentrate and dry the eluent to obtain extract A. The macroporous resin is of type AB-8, D101, HPD100, DM301, HPD300, HPD500 or HPD600. When using a macroporous resin column for elution and purification, the concentration of the loading solution is 1-3 g / mL based on the amount of raw drug, the adsorption flow rate is 1-5 BV / h, the resin column diameter-to-height ratio is 1:4-15, the resin is eluted with 2-8 column volumes of water to remove impurities, and then eluted with 30-90% v / v ethanol for 2-15 resin volumes at an elution flow rate of 1-4 BV / h. When using a polyamide resin column for elution and purification, the concentration of the loading solution is 1~2.5 g / mL based on the amount of raw drug, the adsorption flow rate is 1~5 BV / h, the resin column diameter-to-height ratio is 1:6~8, water is used to wash 2~6 times the resin volume for impurity removal, and 30~75% v / v ethanol is used to wash 3~8 times the resin volume at an elution flow rate of 1~4 BV / h. The herbs other than Dendrobium and Atractylodes macrocephala are extracted with 60-70% v / v ethanol aqueous solution. The extraction is carried out 2-3 times, and the amount of ethanol used each time is 8-12 times that of the herbs. The extracts are combined and filtered. The filtrate is concentrated under reduced pressure until there is no alcohol taste to obtain crude extract. (2) Take Dendrobium and Atractylodes macrocephala, extract twice, each time for 1 to 1.5 hours, each time using 8 to 10 times the weight of the medicinal materials in water, combine the extracts, filter, concentrate the filtrate under reduced pressure to a relative density of 1.20 to 1.25, precipitate with 95% ethanol to a concentration of 70 to 80%, let stand overnight, filter, concentrate the filtrate under reduced pressure, dry, pulverize, and obtain extract B; (3) Mix A and B.

4. The preparation method according to claim 3, characterized in that, When using a macroporous resin column for elution and purification in step (1), macroporous resins of type AB-8, HPD300, or D101 are preferred.

5. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicine for treating functional dyspepsia in children.

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