Traditional Chinese medicine composition for tonifying spleen and promoting appetite for children as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for tonifying spleen and promoting appetite for children as well as a preparation method and application thereof, and belongs to the field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 to 30 parts of fructus crataegi, 10 to 30 parts of light wheat, 5 to 15 parts of malt, 5 to 15 parts of medicated leaven, 3 to 9 parts of endothelium corneum gigeriae galli, 5 to 15 parts of semen raphani, 5 to 15 parts of rhizoma atractylodis macrocephalae and 3 to 9 parts of pericarpium citri reticulatae. The traditional Chinese medicine composition provided by the invention transports without hurting body resistance, tonifies without greasy stagnation, has mild drug properties, does not have drastic and strong substances, has homology of medicine and food, and can benefit and nourish qi of internal organs of children while promoting, eliminating and transporting. Animal experiments show that the traditional Chinese medicine composition provided by the invention can effectively relieve the symptoms of spleen deficiency and dyspepsia of rats, improve the concentration of gastrin, motilin and serum P substances in rat blood and reduce the residual rate of gastric contents. Clinical experiments show that the traditional Chinese medicine composition preparation provided by the invention can be used for effectively treating infantile food retention caused by spleen deficiency and dyspepsia.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and relates to a Chinese medicine composition for strengthening the spleen and stimulating appetite for children, and a preparation method and application thereof. Background Art

[0002] The term "food stagnation" was first mentioned in the "New Book of Salesian". It is also called food stagnation, food stagnation, and food injury. It is a common and frequently occurring disease in pediatrics. Children's internal organs are delicate, their physical and qi are not yet full, their yin and yang are immature, and they are prone to change. They often suffer from dysfunction of the spleen and stomach due to improper diet, improper feeding, severe picky eating, and uneven eating, which leads to food stagnation. In clinical Chinese medicine, food stagnation in children can occur alone or in combination with other diseases. The clinical manifestations are loss of appetite, bladder and abdomen distension, sour and sour stool, and sour and smelly stool. This disease is similar to "functional dyspepsia" in Western medicine, with poor appetite, nausea, vomiting, abdominal distension, abdominal pain, and irregular stool as the main manifestations, and is mostly caused by improper diet. It is a group of clinical syndromes that exclude organic lesions of the digestive tract and other systemic diseases. It can also cause anorexia, constipation, sleep disorders, growth and development problems. Western medicine treatments mostly use gastric motility drugs, digestion-promoting drugs, drugs to protect gastric mucosa and drugs to regulate intestinal flora. They cannot provide targeted treatments according to different types of symptoms, and are prone to recurrence, often failing to achieve the expected therapeutic effect. Traditional Chinese medicine treatments for children with food accumulation are mainly based on strengthening the spleen and promoting digestion, eliminating accumulation and relieving stagnation, and replenishing qi and lungs, focusing on the overall regulation of the spleen, stomach and lungs.

[0003] In TCM theory, there is a close relationship between the lungs and the spleen and stomach. The two are interdependent in physiological functions and affect each other in pathology. The internal organs are delicate and the body's qi is not full. In TCM clinical practice, the treatment of food accumulation in children requires comprehensive consideration of the relationship between the spleen, stomach and lungs. (1) Qi and blood generation: The spleen is responsible for transportation and transformation, and is the source of qi and blood generation. It is responsible for transporting and transforming the essence of water and grain to produce qi and blood; the lungs are responsible for breathing and are responsible for the body's qi. By inhaling the clear air from nature and combining it with the qi of water and grain generated by the spleen and stomach, it forms the Zong Qi, which is then distributed throughout the body through the lung's function of connecting to all meridians to maintain the body's life activities. Therefore, the transportation and transformation function of the spleen and stomach directly affects the generation and distribution of lung qi. Therefore, "the lungs are the pivot of the main qi, and the spleen is the source of qi." Water metabolism: In terms of water metabolism, the spleen is responsible for transporting and transforming water, and has the function of raising the clear and lowering the turbid. It can transport water to the lungs, and through the lung's function of spreading and descending, it can spread the water throughout the body or transport it to the bladder for excretion. The lung and spleen work together to maintain the balance of water metabolism in the human body. Therefore, it is said that "the spleen is the source of phlegm, and the lung is the container of phlegm." (2) The spleen and lung affect each other pathologically, mainly in terms of insufficient qi generation and abnormal water metabolism. When the lung qi is insufficient, it will lead to weakened respiratory function and insufficient generation of zong qi, which will in turn affect the transportation and transformation function of the spleen and stomach. When the spleen and stomach are weak, the transportation and transformation function is weakened, and the transformation of water and grain is insufficient, resulting in a lack of source for qi and blood production, and the lung qi will also be insufficient. In addition, spleen and stomach weakness can easily lead to endogenous water and dampness, forming phlegm and dampness. When phlegm and dampness invade the lungs, symptoms such as coughing and expectoration will occur. (3) When food accumulates for a long time in children and turns into heat, it is easy to produce damp heat in the middle jiao. The accumulated heat will consume body fluid and damage qi, and over time it will become malnutrition. The internal organs are blocked, forcing the body fluid to go out and sweating. If the clearing of the internal organs and the restoration of the transportation mechanism are timely, the prognosis is generally good. If it is delayed and not treated, the condition may worsen further.

[0004] Clinically, food accumulation in children is often accompanied by excessive sweating, susceptibility to colds, respiratory tract infections, etc. Currently, there is no Chinese medicine on the market that is targeted at food accumulation in children with weak spleen and stomach and insufficient lung qi. In addition, since the treatment targets children, it is necessary to ensure the efficacy while paying attention to the mildness of the medicine to prevent damage to the vitality of the children. Therefore, there is an urgent need for a Chinese medicine composition that is simpler in formula, has significantly better efficacy, and has mild medicine suitable for children to strengthen the spleen and stimulate appetite. Summary of the invention

[0005] In view of this, in view of the problems existing in the above-mentioned prior art, the purpose of the present invention is to provide a Chinese medicine composition for strengthening the spleen and stimulating appetite for children, and a preparation method and application thereof.

[0006] To achieve the above-mentioned purpose, the present invention provides a Chinese medicine composition for strengthening the spleen and stimulating appetite for children, which comprises the following raw materials by weight: 10-30 parts of hawthorn, 10-30 parts of floating wheat, 5-15 parts of malt, 5-15 parts of Shenqu, 3-9 parts of chicken gizzard lining, 5-15 parts of radish seeds, 5-15 parts of Atractylodes macrocephala and 3-9 parts of tangerine peel.

[0007] Preferably, the Chinese medicine composition comprises the following raw materials by weight: 15-25 parts of hawthorn, 15-25 parts of floating wheat, 8-12 parts of malt, 8-12 parts of Shenqu, 4-8 parts of chicken gizzard lining, 8-12 parts of radish seeds, 8-12 parts of Atractylodes macrocephala and 4-8 parts of tangerine peel.

[0008] More preferably, the Chinese medicine composition comprises the following raw materials by weight: 20 parts of hawthorn, 20 parts of floating wheat, 10 parts of malt, 10 parts of Shenqu, 6 parts of chicken gizzard lining, 10 parts of radish seeds, 10 parts of Atractylodes macrocephala and 6 parts of dried tangerine peel.

[0009] Preferably, the hawthorn is scorched hawthorn, the malt is fried malt, the Shenqu is fried Shenqu with bran, the chicken's gizzard lining is fried chicken's gizzard lining, the radish seeds are fried radish seeds, and the Atractylodes macrocephala is fried Atractylodes macrocephala with bran.

[0010] In the Chinese medicine composition for strengthening the spleen and stimulating appetite for children provided by the present invention, eight raw materials, namely, scorched hawthorn, floating wheat, stir-fried malt, stir-fried Shenqu with bran, stir-fried chicken gizzard lining, stir-fried radish seeds, stir-fried Atractylodes macrocephala with bran and dried orange peel, are properly matched and work synergistically. (1) Scorched hawthorn can help digestion, relieve stagnation and stop diarrhea, and can eliminate all kinds of food stagnation, especially greasy meat stagnation, and has the pharmacological effects of accelerating gastrointestinal emptying and protecting the liver; stir-fried Shenqu with bran can strengthen the spleen and stomach, help digestion and regulate the middle, and can eliminate stale stagnation; stir-fried malt can promote qi and help digestion, and can eliminate rice, noodles and potato stagnation. (2) Stir-fried radish seeds can help digestion and resolve stagnation while reducing qi and eliminating bloating. They are also good at eliminating phlegm and qi from wheat flour, and can regulate immunity and intestinal flora. Stir-fried chicken gizzard lining can relieve stomach stagnation and strengthen the spleen, resolve hard masses and help digestion. Grinding and taking the mixture helps regulate gastrointestinal function. "Where there is hard mass, there must be hidden yang." Children with food stagnation can cause qi stagnation, which can easily turn into heat and steam to escape as sweat. Therefore, floating wheat can be used to consolidate the exterior and stop sweating, replenish qi and eliminate heat. The dosage is the same as that of hawthorn, with the emphasis on replenishing qi and eliminating heat, and clearing away the internal heat caused by yin deficiency caused by long-term depression. (3) Tangerine peel can regulate qi and resolve stagnation, help resolve stagnation and eliminate bloating. Stir-fried white atractylodes with bran can be used for spleen deficiency and food stagnation. It can benefit the spleen and stomach's ascending and descending functions and regulate gastrointestinal smooth muscle movement in both directions. Tangerine peel and stir-fried white atractylodes with bran can replenish qi and strengthen the spleen, attack and supplement at the same time, and eliminate stagnation without hurting the body.

[0011] Preferably, in the traditional Chinese medicine composition, the ratio of the sum of the weights of scorched hawthorn, fried Shenqu with bran and fried malt, the sum of the weights of floating wheat, fried chicken gizzard lining and fried radish seeds, and the sum of the weights of fried Atractylodes macrocephala and dried tangerine peel is 39-41:35-37:16; more preferably 40:36:16.

[0012] On the other hand, the present invention provides a method for preparing a Chinese medicine composition, using the above-mentioned Chinese medicine composition as a raw material for preparation.

[0013] Preferably, the steps in the preparation method include but are not limited to:

[0014] One or more of pulverizing, decocting, water extraction, alcohol extraction, extraction, steam distillation, chromatography extraction, supercritical extraction, ultrasonic extraction, microwave extraction, enzymolysis, fermentation, panning, molding, dripping, pressing, rolling, concentration, and drying.

[0015] In another aspect, the present invention provides the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of medicines for strengthening the spleen, stimulating appetite and promoting digestion.

[0016] In the last aspect, the present invention provides a medicine, comprising the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method.

[0017] Preferably, the active ingredient of the drug includes the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method.

[0018] The drug can be prepared into dosage forms such as pills, capsules, granules, oral liquids, powders, tablets, lozenges, lozenges, pastes, powders, etc., and suitable drug carriers in the art can be selected for different dosage forms.

[0019] The pharmaceutical carrier used can be solid or liquid. Examples of solid carriers include lactose, kaolin, sucrose, talcum powder, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water.

[0020] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions, elixirs and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0021] Tablets containing the Chinese medicine composition of the present invention can be prepared by tableting or molding, optionally with one or more auxiliary ingredients or adjuvants. Tablets can be prepared by tableting the active ingredient in a free-flowing form (such as powder or granules) in a suitable machine, optionally mixed with a binder, lubricant, inert diluent, surfactant or dispersant. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent.

[0022] The paste containing the Chinese medicine composition of the present invention can be prepared by using existing pharmaceutical excipients and production processes. Intermediate products or finished products that can be directly or indirectly extracted, collected, and prepared by using modern technical methods through traditional medicinal pieces or new medicinal pieces such as boiled powder, granules, and powders include modern pastes such as ointments, creams, and gel patches, as well as traditional paste prescriptions. The production process of traditional Chinese medicine paste prescriptions includes the steps of selection, preparation, washing, soaking, decocting, secretion, filtration, collection, packaging, and cooling. Whether to add refined honey is selected according to the actual preparation operation, and quality control is carried out according to modern technical methods such as relative density, insoluble matter, loading amount, microbial limit, water content determination, dynamic viscosity, paste yield, and atlas.

[0023] In addition to the above-mentioned carrier components, possible pharmaceutical preparations prepared using the present formulation may also include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), colorants and flavoring agents.

[0024] Preferably, the dosage form of the drug is selected from one or more of decoction, granules, pills, powders, tablets, oral liquids, lozenges, capsules, and ointments.

[0025] Compared with the prior art, the present invention has the following beneficial effects.

[0026] 1. The Chinese medicine composition provided by the present invention is composed of scorched hawthorn, fried malt, fried Shenqu with bran, fried chicken gizzard lining, fried radish seeds, fried Atractylodes macrocephala with bran, tangerine peel, and floating wheat. The prescription is mainly used to invigorate the spleen and appetite, digest food and eliminate accumulation, and invigorate qi and stop sweating. It is exquisitely compatible, simple, inexpensive, safe and effective, and is used to treat milk and food stagnation caused by weak spleen and stomach and insufficient lung qi in children, fullness in the stomach, loss of appetite, indigestion, and sweating and susceptibility to colds.

[0027] 2. Animal experiments show that the Chinese medicine composition provided by the present invention has the effect of significantly reducing the gastric content residual rate of rats with spleen deficiency and food stagnation, and increasing the concentrations of gastrin, motilin and serum P substance in the blood.

[0028] 3. The present invention utilizes the pathological characteristics of children's internal organs being clear and easy to recover to treat the disease through syndrome differentiation, repeated consideration, and skillful use of the principle, method, and prescription to apply this prescription. The prescription is used without hurting the body, replenishing without being greasy, and has a mild medicinal property without strong ingredients. It takes into account the same origin of medicine and food, and nourishes the qi of children's internal organs while promoting, eliminating, and transporting. Clinical applications show that the Chinese medicine composition provided by the present invention has a significant effect in treating children's food accumulation, providing a guarantee for the effectiveness and stability of clinical applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a bar graph of the experimental results of gastric contents residual rate in rats.

[0030] Figure 2It is a bar graph of the experimental results of gastrin concentration in rats.

[0031] Figure 3 It is a bar graph of the experimental results of motilin concentration in rats.

[0032] Figure 4 It is a bar graph of the experimental results of rat serum substance P concentration. DETAILED DESCRIPTION

[0033] Terms and Claims of the Present Invention:

[0034] 1. The articles “a”, “an” and “the” include plural referents unless expressly limited to one or more referents otherwise.

[0035] 2. Numerical range: Unless otherwise expressly stated, all ranges or ratios disclosed herein will be understood to include any and all sub-ranges or sub-ratios contained therein. For example, a range or ratio of 1 to 30 stated should be considered to be included between a minimum value of 1 and a maximum value of 30, and any sub-range or sub-ratio, integer, decimal, or sub-range or sub-ratio consisting of integers or decimals including the end points.

[0036] According to the records in the "Chinese Materia Medica Dictionary" (Second Edition, compiled by Nanjing University of Chinese Medicine), the medicinal materials information involved in the Chinese medicine composition involved in the present invention is as follows.

[0037] hawthorn

[0038] [Synonyms] Atractylodes, Atractylodes (Er Ya), Atractylodes fruit (Er Ya with Guo Pu's notes), Sheep Atractylodes, Mouse Cha (Compendium of Materia Medica Annotations), Red Claw Fruit (Newly Revised Materia Medica), Atractylodes fruit (Compendium of Materia Medica Illustrated), Red Date Fruit (Guihai Yuhengzhi), Mountain Red Fruit, Sour Jujube, Sneezy Ball, Persimmon Atractylodes Seed (Bai Yi Xuan Fang), Mountain Fruit (Lü Canyan Materia Medica), Atractylodes (Daily Materia Medica), Monkey Atractylodes (Shiyi Dexiao Fang), Azalea Fruit (Jiuhuang Bencao), Sea Red (Pinhui Jingyao), Sour Plum, Mountain Pear (Chinese Tree Taxonomy), Sour Cha (Shandong Traditional Chinese Medicine).

[0039] [Origin] The ripe fruit of Crataegus pinnatifida, a plant of the genus Crataegus in the Rosaceae family.

[0040]

Original plant

[0041] 2. Hawthorn C. pinnatifida Bunge.

[0042] [Harvesting and processing] The fruit is harvested when it matures in September-October. After picking, it is cut into two halves horizontally or vertically while fresh, dried in the sun, or cut into thin slices using a slicer, and dried at 60-65℃.

[0043]

Properties

[0044]

Functions and Indications

[0045] [Processing] The processed products of hawthorn include hawthorn itself, as well as fried hawthorn, burnt hawthorn, hawthorn charcoal, honey hawthorn, brown sugar-processed hawthorn, and earth-fried hawthorn. In the present invention, burnt hawthorn is selected for formulating. The specific processing method of burnt hawthorn is: take clean hawthorn and put it in a pot, heat it with a slow fire, and stir-fry it until the surface is burnt brown and the inside is yellow brown, then take it out and cool it. Burnt hawthorn is good at treating symptoms such as indigestion and diarrhea.

[0046] Floating wheat

[0047] [Synonym] Floating wheat (Compendium of Materia Medica).

[0048] [Origin] The shriveled and frivolous caryopsis of wheat, a plant of the genus Triticum in the Poaceae family.

[0049]

Original plant

[0050] [Harvesting and processing] Around the summer solstice, after the ripe fruits are harvested, take the shriveled, light and unpeeled wheat grains, sieve out the ash, rinse with water and dry them in the sun.

[0051]

Properties

[0052]

Function and indication

[0053] malt

[0054] [Synonyms] Barley paste (Materia Medica), wheat paste (Rihuazi), barley hair (Southern Yunnan Materia Medica), barley malt (Bencao Huiyan).

[0055] [Origin] The germinated caryopsis of barley, a plant of the genus Hordeum in the Poaceae family.

[0056]

Original plant

[0057] [Harvesting and Processing] Malt production can be carried out throughout the year, but winter and spring are the best seasons. Take clean barley, soak it in clean water for 3-4 hours, take it out, put it in a container that can drain water, cover it, and water it 2-3 times a day to keep it moist. When the buds are 2-3mm long, take them out and dry them in the sun.

[0058]

Properties

[0059] [Function and indication] It can help digest food and eliminate stagnation, and restore milk. It can treat food stagnation, abdominal distension and diarrhea, nausea and vomiting, loss of appetite, milk stasis, and breast pain.

[0060] [Processing] The processed products of malt include raw malt, roasted malt, burnt malt, bran roasted malt, etc. In the present invention, roasted malt is selected for formulating. The specific processing method of roasted malt is: take clean malt, put it in a pot, heat it with a slow fire, and roast it until the surface is dark yellow. When burnt spots are occasionally seen, take it out and cool it. Roasted malt can enhance the effect of appetizing and digesting food.

[0061] Divine Comedy

[0062] [Synonyms] Liushenqu (Compendium of Materia Medica), Liuqu (General Name).

[0063] [Source] It is a fermented preparation made by mixing herbs such as Polygonum hydropiper, Artemisia annua, and almond with flour or bran and then fermenting them.

[0064] [Preparation method] Take 7kg each of fresh Polygonum peony root, Artemisia annua and Xanthium sibiricum, chop and juice, take 4kg each of red bean and almond (peeled), grind into powder, take 60kg of bran and 40kg of flour, mix the bran and 60%-80% of flour with the above-mentioned medicines, beat the remaining flour with boiling water into a paste, pour it into the mixed medicine, stir evenly with a wooden stick until it becomes a sticky cake, move it to a wooden board, flatten it to about 1cm thick, cut it into 3cm square pieces with a knife, dry it in the sun for 0.5-1 day, collect it, pile it in a large bamboo plate, cover it with sacks, straw bags or rice and wheat straw, let it ferment, and when mycelium grows on the surface, take it out and dry it.

[0065] [Medicinal Materials] Massa Medicata Fermentata is a processed product.

[0066]

Properties

[0067]

Function and indication

[0068] [Processing] The processed products of Shenqu include Shenqu itself, as well as fried Shenqu, fried Shenqu with bran, and burnt Shenqu. In the present invention, fried Shenqu with bran is selected for formulating. The specific processing method of fried Shenqu with bran is: take clean bran and sprinkle it into a hot pot, wait for smoke to rise, then pour in the Shenqu block, stir-fry until dark yellow, take it out, sieve out the bran, and let it cool. 10kg of bran is used for every 100kg of Shenqu. After being fried with bran, Shenqu has a sweet aroma, which is mainly used to wake up the spleen and stomach.

[0069] Chicken gizzard

[0070] [Synonyms] The yellow skin inside the gizzard of chicken (Ben Jing), the gizzard of chicken (Qian Jin Fang), the yellow skin inside the gizzard of chicken (Rihuazi), the skin of chicken gizzard (Diannan Materia Medica), the yellow skin of chicken (Modern Practical Chinese Medicine), the skin of chicken food (Henan Handbook of Chinese Medicine), the chicken zygote (Shandong Chinese Medicine), the gold in the chicken, the fossilized gallbladder, the bone-dissolving gallbladder (Shanxi Chinese Medicine Records).

[0071] [Origin] It is the lining of the gizzard of the domestic chicken, a species of the Phasianidae family.

[0072] [Original animal] Domestic chicken Gallus gallus domesticus Brisson.

[0073] [Harvesting and processing] When slaughtering, remove the gizzard, peel off the inner wall immediately, wash and dry.

[0074]

Properties

[0075]

Functions and Indications

[0076] [Processing] The processed products of chicken gizzard lining include chicken gizzard lining itself, fried chicken gizzard lining, etc. In the present invention, fried chicken gizzard lining is selected for formulating. The specific processing method of fried chicken gizzard lining is: put the clean chicken gizzard lining on a hot pot, heat it with a slow fire, fry it until it swells, the surface is crispy, the color is deepened, and it is cooled. Sand can also be used as a heat-conducting medium for frying to make it more evenly heated.

[0077] Radish seeds

[0078] [Synonyms] Radish seeds, radish seeds (Baoqing Materia Medica Eclectic).

[0079] [Origin] The mature seeds of radish, a plant of the genus Raphanus in the family Cruciferae.

[0080]

Original plant

[0081] [Harvesting and processing] Harvest and dry the siliques when they are fully mature from May to August of the following year, remove the seeds, and store in a dry place.

[0082] [Drug Properties] Spicy, sweet, neutral. Enters the spleen, stomach, lung, and large intestine meridians.

[0083] [Function and indication] It can help digestion and relieve stagnation, lower qi and resolve phlegm. It is mainly used to treat food stagnation and qi stagnation, abdominal distension, diarrhea, heaviness after dysentery, cough with a lot of phlegm, and qi reversal and wheezing.

[0084] [Processing] The processed products of radish seeds include radish seeds, stir-fried radish seeds, etc. In the present invention, stir-fried radish seeds are selected for formulating. The specific processing method of stir-fried radish seeds is: take clean radish seeds, put them in a pot, heat them with a slow fire, stir-fry them until they swell slightly, and emit fragrance, then take them out and cool them down. Stir-fried radish seeds have a mild medicinal property and are good at reducing qi and resolving phlegm, digesting food and relieving bloating.

[0085] Atractylodes macrocephala

[0086] [Synonyms] Mountain thistle, Yangfu thistle (Erya), Atractylodes (Benjing), Mountain mustard, Tianji (Wu Pu Materia Medica), Alpinia galanga (Guangya), Rhizoma Coptis (Bielu), Mountain spirit (Shennong Herbal Classic), Kilika (Nanfang Caomu Zhuang), Atractylodes macrocephala (Depei Materia Medica).

[0087] [Origin] The rhizome of Atractylodes macrocephala, a plant of the genus Atractylodes in the Asteraceae family.

[0088]

Original plant

[0089] [Harvesting and processing] From late October to early November, when the above-ground part withers, choose a sunny day to dig up the roots, cut off the stems, and dry the rhizomes. The drying temperature starts at 100℃. When the skin becomes hot, reduce the temperature to 60-70℃. Turn it upside down every 4-6 hours. When it is half dry, rub off the fibrous roots, and dry it until it is 80% dry. Take it out and stack it for 5-6 days to soften the skin, and then dry it until it is completely dry. It can also be dried in the sun for 15-20 days until it is completely dry.

[0090]

Properties

[0091] [Functions and indications] Strengthen the spleen and replenish qi, dry dampness and promote diuresis, stop sweating and stabilize the fetus. It is mainly used to treat fatigue caused by spleen deficiency, abdominal distension due to loss of appetite, diarrhea and constipation, urinary incontinence caused by water retention, edema, dizziness caused by phlegm and fluid retention, cold and dampness, body pain, spontaneous sweating caused by qi deficiency, and restless fetus.

[0092] [Processing] The processed products of Atractylodes macrocephala include Atractylodes macrocephala, stir-fried Atractylodes macrocephala, stir-fried Atractylodes macrocephala with bran, stir-fried Atractylodes macrocephala with soil, processed Atractylodes macrocephala with rice, salted Atractylodes macrocephala, steamed Atractylodes macrocephala, charcoal Atractylodes macrocephala, etc. In the present invention, stir-fried Atractylodes macrocephala with bran is selected for formulating. The specific processing method of stir-fried Atractylodes macrocephala with bran is as follows: take bran and sprinkle it into a hot pot, heat it with medium heat, pour in Atractylodes macrocephala slices when the bran smokes, stir-fry until the surface is dark yellow, and when the aroma escapes, take it out, sieve out the bran, and let it cool. Stir-fried Atractylodes macrocephala with bran is biased towards removing dampness and promoting diuresis.

[0093] Tangerine peel

[0094] [Other names] Tangerine peel (Ben Jing), Guilao (Hou Ningji's Yao Pu), yellow tangerine peel (Jifeng Puji Fang), red peel (Tangye Materia Medica), tangerine peel (Diannan Materia Medica), Guang tangerine peel (Deyi Materia Medica).

[0095] [Source] The mature peel of Citrus reticulata Blanco [C.nobilis lour., C.deliciosa Ten] and its cultivated varieties.

[0096]

Original Plant

[0097] 2. Citrus reticulata Blanco.

[0098] [Harvesting and processing] Pick the fruits when they are ripe from September to December, peel off the peel, and dry them in the shade or in the sun.

[0099]

Properties

[0100]

Functions and indications

[0101] The following non-limiting examples can enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way. The following content is merely an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of the present invention.

[0102] The present invention is further described below by way of specific examples. The various raw materials used in the examples of the present invention are obtained through conventional commercial channels unless otherwise specified. Unless otherwise specified, the contents described below are all weight contents. Unless otherwise specified, it is understood that the process is carried out at room temperature.

[0103] Example 1-Example 7 provides a Chinese medicine composition for strengthening the spleen and stimulating appetite for children, and the weight parts of the raw materials are shown in Table 1 (unit: weight parts).

[0104] Table 1

[0105] Element Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Burnt Hawthorn 20 15 25 10 30 30 16 Floating wheat 20 25 15 30 10 30 10 Roasted malt 10 12 8 15 5 5 9 Fried gluten with rice 10 12 8 15 5 5 15 Fried Chicken Gizzard 6 4 8 3 9 3 9 Fried radish seeds 10 8 12 5 15 5 15 Fried Atractylodes macrocephala with bran 10 8 12 5 15 10 15 Tangerine peel 6 8 4 9 3 4 3

[0106] Comparative Examples 1 to 3 provide a Chinese medicine composition for strengthening the spleen and stimulating appetite for children. The weight parts of the raw materials are shown in Table 2 (unit: weight part, "-" means that the ingredient is not contained).

[0107] Table 2

[0108]

[0109]

[0110] As an example, the preparation method of the composition of the present invention can be implemented with reference to the prior art, as follows:

[0111] The Chinese medicine compositions provided in Examples 1 to 7 and Comparative Examples 1 to 3 were soaked in water, boiled for 1 hour, filtered to obtain the first filtrate for standby use, and the residues were boiled in water for 1 hour and then filtered to obtain the second filtrate. The filtrates obtained by the two filtrations were collected and combined, concentrated under reduced pressure, and freeze-dried to obtain a Chinese medicine freeze-dried powder.

[0112] Effect evaluation:

[0113] 1. Evaluation of animal experiments.

[0114] 1. Experimental methods

[0115] A rat model of spleen deficiency and food stagnation was established with reference to the prior art.

[0116] The specific method is as follows:

[0117] SD rats (weight 200 g ± 20 g) were raised for 1 week to adapt to the environment. The rats were gavaged with cooked Rehmannia root decoction (the cooked Rehmannia root decoction was concentrated to 2 g of raw medicine per ml, and the dose was 3.12 g of raw medicine per kg of rat body weight per day) every day for 14 consecutive days to establish the model of spleen deficiency and food stagnation in rats.

[0118] The model rats and non-model rats were grouped separately:

[0119] Blank control group: rats without model construction were gavaged with distilled water.

[0120] Model control group: model-constructed rats were gavaged with distilled water.

[0121] Example group / comparative example group:

[0122] The Chinese medicine compositions of each embodiment and comparative example were prepared into Chinese medicine freeze-dried powder according to the preparation example, and then dissolved with an appropriate amount of distilled water to form a medicinal solution. The model-constructed rats were gavaged with the above medicinal solutions prepared from the Chinese medicine compositions of Examples 1 to 7 and Comparative Examples 1 to 3, respectively.

[0123] Dosage: The daily dosage for rats is 16.56 g / kg rat body weight / day (calculated as raw drug amount).

[0124] Take the average weight of 6-year-old children as 25kg, and the daily dose is 3.68g / kg (calculated as crude drug).

[0125] The conversion formula for experimental animal and human clinical drug dosage proposed in "Methodology of Chinese Medicine Pharmacology Research" is used for conversion:

[0126]

[0127] Among them, dA and dB are the known animal's kilogram body weight dose and the animal's kilogram body weight dose to be calculated, respectively; RA and RB are the known animal's body size coefficient and the animal's body size coefficient to be calculated, respectively; WA and WB are the known animal's body weight and the animal's body weight to be calculated, respectively.

[0128] Here RA is the body size coefficient of children, which is 0.1; RB is the body size coefficient of rats, which is 0.09; WA is the weight of children, which is 25 kg; and WB is the weight of rats, which is 0.2 kg.

[0129]

[0130] That is, the daily dosage for rats was 16.56 g / kg rat body weight (calculated as crude drug amount).

[0131] Time of administration:

[0132] Administer the drug continuously for 14 days.

[0133] 2. Effect evaluation:

[0134] After the treatment was completed, the rats were fasted but not watered for 24 hours before the last administration. Each group of rats was gavaged with 0.5 g of charcoal semisolid paste. After 30 minutes, 10% chloral hydrate 3.5 μL / g body weight was used for intraperitoneal anesthesia. Blood was collected from the abdominal aorta, divided into portions, and stored in a -80°C refrigerator. The levels of gastrin, plasma motilin, and serum substance P were determined by ELISA.

[0135] After blood was collected from the abdominal aorta of the rats, the abdominal cavity was exposed, the gastric cardia and pylorus were ligated, the stomach was taken out, and the whole stomach weight was weighed after being wiped dry with filter paper. The stomach body was cut open along the greater curvature of the stomach, and the stomach contents were rinsed clean with 4°C 0.9% saline, then wiped dry and the net weight of the stomach was weighed.

[0136] Gastric content residual rate = (total stomach weight - net stomach weight) ÷ total weight of charcoal semi-solid paste × 100%.

[0137] Statistical analysis method: All the above data were analyzed by Graphpad Prism 8 software, and all data were expressed as mean ± standard deviation. The t-test was used to analyze the significant difference between the two experimental groups.

[0138] The experimental results of the gastric content residual rate of rats in each group are shown in Table 3 below (mean ± standard deviation, "-" means no content, n = 5).

[0139] Table 3

[0140] Group Gastric content residual rate (%) Blank control group 3.06±0.19 Model control group <![CDATA[4.02±0.23 aaa / bbbb ]]> Example 1 Group <![CDATA[2.02±0.15 aaaa / bbb ]]> Example 2 Group <![CDATA[3.10±0.17 b / cccc ]]> Example 3 Group <![CDATA[3.37±0.19 bb / cccc ]]> Example 4 Group <![CDATA[3.13±0.28 cccc ]]> Example 5 Group <![CDATA[3.49±0.38 cccc ]]> Example 6 Group <![CDATA[3.36±0.26 b / cccc ]]> Example 7 Group <![CDATA[3.25±0.20 bb / cccc ]]> Comparative Example 1 <![CDATA[3.70±0.34 cccc ]]> Comparative Example 2 <![CDATA[3.79±0.38 a / cccc ]]> Comparative Example 3 <![CDATA[3.43±0.29 cccc ]]>

[0141] Significant difference markers:

[0142] Compared with the blank control group: aaaa means p < 0.0001, aaa means p < 0.001, a means p < 0.05;

[0143] Compared with the model control group: bbbb means p < 0.0001, bbb means p < 0.001, bb means p < 0.01, and b means p < 0.05;

[0144] Compared with the Example 1 group: cccc indicates p<0.0001.

[0145] The bar graph of the experimental results of gastric content residual rate of rats in each group is as follows Figure 1 shown.

[0146] The above experimental results show that:

[0147] Compared with the blank control group, the residual rate of gastric contents in the model control group was significantly increased, indicating that the digestive ability of the model animals was greatly inhibited and the modeling was successful.

[0148] The Chinese medicine compositions of Examples 1 to 7 can all significantly reduce the gastric content residual rate of modeling rats.

[0149] Although the Chinese medicine compositions of Comparative Examples 1 to 3 can also reduce the residual rate of gastric contents in rats, the effects are not as good as those of the Chinese medicine compositions of Examples 1 to 7.

[0150] The effect of reducing the residual rate of gastric contents in modeling rats in Example 1 was better and significantly better than that in Example 2 to Example 7 and Comparative Example 1 to Comparative Example 3.

[0151] Gastrin (GAS), motilin (MTL) and serum substance P (SP) in the blood samples of rats in each group were detected. The experimental results are shown in the following Table 4 (mean ± standard deviation, n = 5).

[0152] Table 4

[0153] Group Gastrin concentration (pg / mL) Motilin concentration (pg / mL) Serum substance P concentration (pg / mL) Blank control group 142.99±35.38 93.07±41.31 20.46±4.08 Model control group 121.14±30.84 75.40±12.97 <![CDATA[10.29±3.12 aa ]]> Example 1 Group <![CDATA[270.67±22.36 aaa / bbbb ]]> <![CDATA[204.96±39.70 aa / bbb ]]> <![CDATA[45.68±2.98 aaaa / bbbb ]]> Example 2 Group <![CDATA[163.07±43.44 cc ]]> <![CDATA[113.21±26.67 cc ]]> <![CDATA[24.97±7.60 ccc ]]> Example 3 Group <![CDATA[158.17±37.60 cc ]]> <![CDATA[108.19±28.89 cc ]]> <![CDATA[23.19±6.72 ccc ]]> Example 4 Group <![CDATA[152.84±59.48 cc ]]> <![CDATA[106.30±34.79 cc ]]> <![CDATA[24.93±10.06 cc ]]> Example 5 Group <![CDATA[156.89±44.48 cc ]]> <![CDATA[108.68±25.57 cc ]]> <![CDATA[22.74±7.64 ccc ]]> Example 6 Group <![CDATA[145.55±30.66 cc ]]> <![CDATA[100.87±34.65 cc ]]> <![CDATA[23.24±9.34 cc ]]> Example 7 Group <![CDATA[143.67±41.34 cc ]]> <![CDATA[107.17±46.73 cc ]]> <![CDATA[21.52±6.91 ccc ]]> Comparative Example 1 <![CDATA[143.61±48.48 cc ]]> <![CDATA[98.35±36.56 ccc ]]> <![CDATA[21.10±6.08 ccc ]]> Comparative Example 2 <![CDATA[141.50±36.69 cc ]]> <![CDATA[94.41±29.79 ccc ]]> <![CDATA[17.46±7.74 cccc ]]> Comparative Example 3 <![CDATA[143.29±49.74 cc ]]> <![CDATA[102.23±44.64 ccc ]]> <![CDATA[17.76±2.10 cccc ]]>

[0154] The experimental results of gastrin concentration, motilin concentration and serum substance P concentration of each group of rats are shown in the bar graphs as follows: Figure 2-Figure 4 shown.

[0155] Comparison of data in the same column, significant difference marks:

[0156] Compared with the blank control group: aaaa means p < 0.0001, aaa means p < 0.001, aa means p < 0.01;

[0157] Compared with the model control group: bbbb means p < 0.0001, bbb means p < 0.001;

[0158] Compared with the Example 1 group: cccc represents p<0.0001, ccc represents p<0.001, and cc represents p<0.01.

[0159] There was a significant difference in serum substance P concentration between the blank control group and the model control group; although the concentrations of gastrin and motilin did not reach the significant difference level of p < 0.05, the average values ​​of gastrin, motilin and serum substance P concentration in the model control group were lower than those in the blank control group, indicating that the digestive function of rats gavaged with Rehmannia glutinosa decoction was reduced to a certain extent. However, as for the pathogenesis of the model animals, since there was no significant difference, it is speculated that it may not be caused by the reduction of gastrin and motilin concentrations, but the reduction of serum substance P concentration may be a way to cause the disease in the model animals.

[0160] After intragastric administration of the liquid prepared by the Chinese medicine composition provided in Example 1-Example 7 and Comparative Example 1-Comparative Example 3, the gastrin concentration, motilin concentration, and serum substance P concentration of the rats were increased to varying degrees relative to the blank control group and the model control group. This shows that in the process of correcting the reduction of digestive function caused by Rehmannia glutinosa decoction, the Chinese medicine compositions provided in Example 1-Example 7 and Comparative Example 1-Comparative Example 3 can produce a positive effect on gastrin concentration, motilin concentration, and serum substance P. Combined with the results of the gastric content residual rate experiment, this positive effect may be a mechanism to promote the improvement of the digestive function of the model.

[0161] It is particularly pointed out that the Chinese medicine composition provided in Example 1 has a more prominent effect in increasing the gastrin concentration, motilin concentration and serum substance P concentration in rats, and can further improve the digestive function of rats. Therefore, for the technical solutions of all the embodiments, the present invention selected Example 1 for clinical effect evaluation.

[0162] 2. Evaluation of clinical effects.

[0163] All cases were from children with food accumulation in children (spleen deficiency and food stagnation syndrome) in the pediatric outpatient department of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine. Cases with incomplete data and interrupted treatment were excluded, and the cases that met the requirements were summarized: 100 cases in the treatment group and 100 cases in the control group. There was no significant statistical difference in gender, age, and course of disease between the two groups, and they were comparable.

[0164] 1. Diagnostic criteria:

[0165] 1.1 Western medicine diagnostic criteria

[0166] Developed with reference to the "Consensus on Diagnosis and Treatment of Functional Dyspepsia in Chinese Children".

[0167] Children aged 36 months and older have had indigestion symptoms for at least 2 months, at least once a week, and meet the following three conditions:

[0168] (1) Continuous or recurrent upper abdominal pain, burning sensation in the upper abdomen, abdominal distension after meals, early satiety, belching, nausea, vomiting, acid reflux, etc.;

[0169] (2) symptoms cannot be relieved after defecation or the onset of symptoms is not related to changes in defecation frequency or stool characteristics;

[0170] (3) After appropriate evaluation, the symptoms cannot be explained by other diseases.

[0171] 1.2 Standards for TCM Syndrome Differentiation

[0172] This prescription is formulated with reference to the Expert Consensus on the Diagnosis and Treatment of Functional Dyspepsia in Children with Integrated Traditional Chinese and Western Medicine and the functional characteristics of this prescription:

[0173] (1) Main symptoms: ① abdominal distension; ② abdominal distension and pain; ③ poor appetite.

[0174] (2) Secondary symptoms: ① Pale complexion; ② Thin body; ③ Fatigue and weakness in limbs; ④ Excessive sweating; ⑤ Loose stools with undigested food.

[0175] (3) Tongue and pulse: Pale tongue with thin white fur and slow and weak pulse.

[0176] If you have the main symptoms and secondary symptoms, you can make a diagnosis by referring to the tongue and pulse.

[0177] 2. Selection of trial groups and treatment options

[0178] 2.1 Inclusion criteria

[0179] (1) Comply with the diagnostic standards of Western medicine and the standards of traditional Chinese medicine differentiation of syndromes.

[0180] (2) Age range: 3-17 years old.

[0181] (3) Disease duration > 2 months.

[0182] (4) The informed consent process complies with regulations, and the legal guardian or the subject (≥8 years old) jointly signs the informed consent form.

[0183] 2.2 Exclusion criteria

[0184] (1) Indigestion caused by other serious organic diseases, such as gastric ulcer, duodenal ulcer, congenital gastrointestinal malformation, inflammatory bowel disease, etc.

[0185] (2) Patients with severe damage to the functions of important organs such as the heart, liver, and kidneys, or other systemic diseases that affect the assessment of digestive system function.

[0186] (3) Those who are allergic to the study drugs.

[0187] (4) Children who have participated in other clinical trials within 12 weeks or are currently participating in other drug clinical trials.

[0188] (5) Other diseases or conditions that, according to the investigator's judgment, reduce the likelihood of enrollment or complicate enrollment.

[0189] 3. Exit (dropout) criteria

[0190] 3.1 Investigator’s decision to withdraw

[0191] (1) Allergic reactions or serious adverse events occur, and treatment should be discontinued according to the doctor's judgment;

[0192] (2) During the trial, other diseases occur that affect the judgment of efficacy and safety;

[0193] (3) The children have poor compliance (compliance with the trial medication is less than 80%, or greater than 120%), or they automatically change medications midway or add Chinese or Western medicines that are prohibited by this protocol;

[0194] (4) Those who are found to seriously violate the inclusion or exclusion criteria after randomization;

[0195] 3.2 Subjects’ Voluntary Withdrawal

[0196] (1) For whatever reason, the patient is unwilling or unable to continue the clinical trial and requests the research physician to withdraw from the trial, thereby terminating the trial;

[0197] (2) Children who did not explicitly request to withdraw from the trial but no longer received medication or testing and were lost to follow-up.

[0198] 4. Dosage regimen

[0199] (1) Treatment group: The Chinese medicine composition provided in Example 1 was used to prepare a decoction.

[0200] The drug composition includes charred hawthorn, stir-fried malt, stir-fried Shenqu with bran, stir-fried chicken gizzard lining, stir-fried radish seeds, stir-fried Atractylodes macrocephala with bran, dried orange peel, and floating wheat. The preparation method is as follows: the Chinese medicine pieces according to the patient's prescription amount are placed in a closed pressure extractor, soaked in 6 times water for 30 minutes, decocted for 1 hour, and repeated twice; the filtrates obtained by the two filtrations are collected and combined, and concentrated under reduced pressure to a relative density of 1.15 (70° C.), and the obtained liquid medicine is vacuum packaged.

[0201] Oral administration: 3-6 years old, 100 mL at a time; 7-17 years old, 200 mL at a time, twice a day. The course of treatment is 2 weeks. If the main symptoms disappear, the medication can be stopped at any time for observation.

[0202] (2) Control group: Jianweixiaoshi oral liquid (Specification: 10 mL / tube, 12 tubes / box, National Medicine Standard No. Z20030094); Validity period: 18 months; Drug composition: Radix Pseudostellariae, dried orange peel, Chinese yam, malt (fried), hawthorn. Oral administration: 3-6 years old, 10 mL at a time; 7-17 years old, 20 mL at a time, twice a day. The course of treatment is 2 weeks. If the main symptoms disappear, the drug can be stopped at any time for observation.

[0203] (3) Grading and quantitative standards for symptoms of spleen deficiency and food stagnation syndrome: formulated with reference to the "Expert Consensus on the Diagnosis and Treatment of Functional Dyspepsia in Children with Integrated Traditional Chinese and Western Medicine (2022)", "Technical Guidance for Clinical Research on New Chinese Medicines for Functional Dyspepsia", and "Expert Consensus on the Diagnosis and Treatment of Functional Dyspepsia in Traditional Chinese Medicine (2023)". The grading and quantitative standards for symptoms of spleen deficiency and food stagnation syndrome are shown in Table 5 below ("-" represents no content):

[0204] Table 5

[0205]

[0206] 5. Overall efficacy assessment

[0207] The reduction ratio of the total score of TCM symptoms was used as the observation index:

[0208] Therapeutic index n (nimodipine method) = [(score before treatment - score after treatment) / score before treatment] × 100%.

[0209] Recovery: clinical symptoms and signs disappear or almost disappear, n≥95%;

[0210] Markedly effective: clinical symptoms and signs were significantly improved, n≥70%;

[0211] Effective: clinical symptoms and signs improved, n ≥ 30%;

[0212] Ineffective: clinical symptoms and signs were not improved or even aggravated, n < 30%.

[0213] 6. Statistical analysis methods

[0214] After the clinical study, statistical analysis was performed using SPSS26. The chi-square test was used to compare the count data; the rank sum test was used for the rank data; the normal analysis was performed on the measurement data, and the measurement data that met the normal analysis were expressed as X±S. The two independent sample t tests were used for inter-group comparisons; the measurement data that did not meet the normal distribution were expressed as M(P 25 , P 75 ) indicates that two independent sample nonparametric tests (rank sum test) were used between the groups to determine whether there was a significant difference between them by comparing the rank sum difference of the two samples. p < 0.05 indicates that the difference is statistically significant, and p < 0.01 indicates that the difference is statistically significant. p > 0.05 indicates that the difference is not statistically significant.

[0215] 7. Analysis of treatment results:

[0216] 1) The comparison of the total effective rate after treatment is shown in Table 6 below:

[0217] Table 6

[0218]

[0219] After treatment, 39 cases in the treatment group were cured, 45 cases were markedly effective, 13 cases were effective, and 3 cases were ineffective; 19 cases in the control group were cured, 42 cases were markedly effective, 26 cases were effective, and 13 cases were ineffective. The total effective rate of the treatment group was 97%, and the total effective rate of the control group was 87%. The result of the rank sum test was Z = -4.121, p < 0.001, which was statistically significant, indicating that the overall efficacy of the treatment group was better than that of the control group.

[0220] 2) The comparison of total scores after treatment is shown in Table 7 below.

[0221] Table 7

[0222]

[0223]

[0224] After treatment, the normality test showed that the treatment group: P = 0.005, the control group: P = 0.161, one of the groups did not conform to the normal distribution, so the two-sample rank sum test was used, Z = -3.048, p = 0.002 < 0.01, indicating that the total score of the treatment group was significantly better than that of the control group.

[0225] 3) The comparison of the scores of the main symptoms after treatment is shown in Table 8 below.

[0226] Table 8

[0227]

[0228] After treatment, the main symptom scores of abdominal distension, poor appetite, and abdominal pain and distension in the treatment group and the control group did not conform to the normal distribution after normality test, so the two-sample rank sum test was used, and the results were as follows: abdominal distension: Z = -2.830, p = 0.005 < 0.01; poor appetite: Z = -2.906, p = 0.004 < 0.01; indicating that the treatment group was significantly better than the control group in improving the symptom scores of abdominal distension and distension, poor appetite; abdominal pain and distension: Z = -2.541, p = 0.011 < 0.05, indicating that the treatment group was better than the control group in improving the abdominal pain and distension.

[0229] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for strengthening the spleen and stimulating appetite in children, characterized in that: The following raw materials are included by weight: 10-30 parts of hawthorn, 10-30 parts of floating wheat, 5-15 parts of malt, 5-15 parts of Shenqu, 3-9 parts of chicken's gizzard lining, 5-15 parts of radish seeds, 5-15 parts of atractylodes macrocephala and 3-9 parts of dried tangerine peel.

2. The Chinese medicine composition according to claim 1, characterized in that: The following raw materials are included by weight: 15-25 parts of hawthorn, 15-25 parts of floating wheat, 8-12 parts of malt, 8-12 parts of Shenqu, 4-8 parts of chicken's gizzard lining, 8-12 parts of radish seeds, 8-12 parts of atractylodes macrocephala and 4-8 parts of dried tangerine peel.

3. The Chinese medicine composition according to claim 2, characterized in that: The following raw materials are included by weight: 20 parts of hawthorn, 20 parts of floating wheat, 10 parts of malt, 10 parts of Shenqu, 6 parts of chicken's gizzard lining, 10 parts of radish seeds, 10 parts of atractylodes macrocephala and 6 parts of dried orange peel.

4. The Chinese medicine composition according to claim 1, characterized in that: The hawthorn is scorched hawthorn, the malt is fried malt, the Shenqu is fried Shenqu with bran, the chicken's gizzard lining is fried chicken's gizzard lining, the radish seeds are fried radish seeds, and the Atractylodes macrocephala is fried Atractylodes macrocephala with bran.

5. The Chinese medicine composition according to claim 4, characterized in that: The ratio of the sum of the weight of scorched hawthorn, fried Shenqu and fried malt, the sum of the weight of floating wheat, fried chicken gizzard lining and fried radish seeds, and the sum of the weight of fried Atractylodes macrocephala and dried tangerine peel is 39-41:35-37:

16.

6. A method for preparing a Chinese medicine composition, characterized in that: The preparation method is prepared by using the Chinese medicine composition described in any one of claims 1 to 5 as a raw material.

7. The preparation method according to claim 6, characterized in that: The steps in the preparation method include: one or more of crushing, decocting, water extraction, alcohol extraction, extraction, steam distillation, chromatography extraction, supercritical extraction, ultrasonic extraction, microwave extraction, enzymolysis, fermentation, panning, molding, dripping, pressing, rolling, concentration and drying.

8. Use of the Chinese medicine composition described in any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method described in any one of claims 6 to 7 in the preparation of drugs for strengthening the spleen, stimulating appetite and promoting digestion.

9. A drug, characterized in that The invention relates to a Chinese medicine composition comprising the Chinese medicine composition described in any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method described in any one of claims 6 to 7.

10. The drug according to claim 9, characterized in that The dosage form of the drug is selected from one or more of decoction, granules, pills, powders, tablets, oral liquids, lozenges, capsules, and ointments.

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