Traditional Chinese medicine composition for strengthening spleen, harmonizing stomach, regulating qi and eliminating mass, preparation method, pharmaceutical preparation and application

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for strengthening spleen, harmonizing stomach, regulating qi and eliminating mass, a preparation method, a pharmaceutical preparation and application. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 300 to 400 parts of radix bupleuri, 300 to 400 parts of fructus aurantii immaturus, 350 to 450 parts of rhizoma atractylodis macrocephalae, 350 to 450 parts of radix codonopsis, 350 to 450 parts of fructus crataegi, 150 to 250 parts of flos inulae and 350 to 450 parts of pericarpium citri reticulatae. The radix bupleuri mainly enters the liver and gallbladder and has the effects of rising yang qi and soothing liver-qi stagnation, and the fructus aurantii immaturus has the effects of regulating qi and relieving qi stagnation, discharging heat and breaking stagnation and is used as a monarch drug together with the radix bupleuri for ascending and descending, ascending lucidity and descending turbid, regulating qi and eliminating mass. The codonopsis pilosula is used for tonifying the spleen, benefiting the lung, nourishing the blood, promoting the secretion of saliva or body fluid and supporting the healthy energy as a ministerial drug; the hawthorn, the inula flower and the pericarpium citri reticulatae are used for regulating qi-flowing for strengthening spleen, and the hawthorn, the inula flower and the pericarpium citri reticulatae are used as assistants. All the medicines are combined to achieve the effects of tonifying spleen, harmonizing stomach, regulating qi and eliminating mass. The traditional Chinese medicine composition can effectively promote gastric emptying and small intestine propulsion and regulate digestive hormone secretion.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for strengthening the spleen and stomach, regulating qi and relieving fullness, a preparation method, a pharmaceutical preparation and an application thereof. Background Art

[0002] Fullness and stuffiness is a disease mainly characterized by discomfort and fullness in the epigastric and abdominal regions due to disharmony of the spleen and stomach functions, disorder of ascending and descending, and stagnation of stomach qi. The book "Treatise on the Causes and Symptoms of Various Diseases - Treatise on Fullness and Stuffiness" points out that "for various cases of fullness and stuffiness, the nutrient qi and defensive qi are not in harmony, yin and yang are separated, the zang-fu organs are blocked and not dredged, so it is called fullness and stuffiness", and "the symptoms of this disease are only qi stagnation and distension in the abdomen, blockage and inaccessibility". Zhang Jiebin in "Complete Works of Jingyue - Fullness and Stuffiness" differentiated the symptoms of fullness and stuffiness into deficiency and excess syndromes, stating that "for those with fullness and stuffiness due to pathogenic factors and stagnation, it is excess fullness and stuffiness; for those without pathogenic factors and stagnation, it is deficiency fullness and stuffiness", that is, fullness and stuffiness are divided into excess fullness and stuffiness and deficiency fullness and stuffiness. Excess fullness and stuffiness includes syndromes of food retention in the diet, phlegm-dampness obstructing the middle-jiao, damp-heat obstructing the stomach, and disharmony between the liver and the stomach; deficiency fullness and stuffiness includes syndromes of weakness of the spleen and stomach and deficiency of stomach yin. In modern medicine, symptoms of fullness and stuffiness are often seen in diseases such as functional dyspepsia and chronic gastritis.

[0003] Chinese invention patent CN111643588A provides a traditional Chinese medicine composition for treating functional dyspepsia, which is composed of the following components by mass percentage: Bupleuri Radix 5%-8%, Aurantii Fructus Immaturus 15%-25%, Paeoniae Radix Alba 10%-20%, Codonopsis Pilosulae Radix 3%-6%, Atractylodis Macrocephalae Rhizoma 10%-20%, Poria 10%-20%, Citri Reticulatae Pericarpium 5%-8%, Pinelliae Rhizoma Praeparatum 5%-8%, Crataegi Fructus 15%-25%, Magnoliae Officinalis Cortex 5%-8%, Glycyrrhizae Radix Preparata 3%-5%. This technology also discloses a preparation method of the capsule of the above traditional Chinese medicine composition for treating functional dyspepsia.

[0004] Chinese invention patent CN105343865A provides a drug for treating nervous vomiting and its preparation method, which is composed of the compatibility of Bupleuri Radix, Pinelliae Rhizoma, Bambusae Caulis in Taenia, Paeoniae Radix Alba, Poria, Atractylodis Macrocephalae Rhizoma, Magnoliae Officinalis Cortex, Citri Reticulatae Pericarpium, Perillae Folium, Codonopsis Pilosulae Radix, Dioscoreae Rhizoma, Amomi Fructus Rotundus, Cinnamomi Ramulus, Inulae Flos, Haematitum, Cyperi Rhizoma. The drug of this technology has the functions of suppressing the adverse flow of qi and stopping vomiting, clearing fullness and dissipating stagnation, tonifying the spleen and regulating the stomach, and calming the mind and tranquilizing the nerves, and is used for treating nervous vomiting.

[0005] Chinese invention patent CN1772085A provides an extract for treating functional dyspepsia and its pharmaceutical composition. The extract is prepared from Atractylodis Macrocephalae Rhizoma, Aurantii Fructus Immaturus, Bupleuri Radix and Crataegi Fructus through a method comprising the following steps. 1. Take a part of Atractylodis Macrocephalae Rhizoma and pulverize it into fine powder. 2. Extract Aurantii Fructus Immaturus and Crataegi Fructus with alkaline alcohol, adjust the pH value of the extract to neutral with acid, and then concentrate it to a paste. 3. The medicinal residues of Aurantii Fructus Immaturus and Crataegi Fructus after extraction in step 2 are extracted with water together with Bupleuri Radix and the remaining Atractylodis Macrocephalae Rhizoma, adjust the pH value of the extract to neutral with acid, concentrate it, add ethanol to make the ethanol content reach 50%-80%, filter to obtain the supernatant, and concentrate it to a paste. 4. Combine and mix the fine powder obtained in step 1 and the pastes obtained in steps 2 and 3 to obtain the product.

[0006] However, the Chinese herbal extracts for treating functional dyspepsia provided by the prior art still have problems such as large formula, unclear compatibility ideas or the efficacy still needs to be improved. Summary of the invention

[0007] Terms and Claims of the Present Invention:

[0008] 1. As used herein, the articles "a", "an" and "the" include plural referents unless expressly limited to one or more referents otherwise.

[0009] 2. As used herein, numerical range: Unless otherwise expressly indicated, all ranges or ratios disclosed herein will be understood to include any and all sub-ranges or sub-ratios contained therein. For example, a range or ratio of 1 to 30 stated should be considered to be included between a minimum value of 1 and a maximum value of 30, and any sub-range or sub-ratio, integer, decimal, or sub-range or sub-ratio consisting of integers or decimals including the end points.

[0010] 3. As used herein, the terms "comprises", "includes", "has", "may", "contain" and their variations are open-ended conjunctions or terms that do not exclude the possibility of additional compositions or structures.

[0011] In view of the deficiencies of the prior art, the present invention aims to provide a Chinese medicine composition, preparation method, pharmaceutical preparation and application for strengthening the spleen and stomach, regulating qi and eliminating abdominal distension. The Chinese medicine composition has the effects of strengthening the spleen and stomach, regulating qi and eliminating abdominal distension, and has the advantages of concise formula, clear compatibility ideas and better efficacy compared with the prior art.

[0012] To achieve the above-mentioned object of the invention, the technical solution of the present invention is as follows:

[0013] On the one hand, the present invention provides a traditional Chinese medicine composition for strengthening the spleen and stomach, regulating qi and eliminating abdominal distension, wherein the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 300-400 parts of bupleurum, 300-400 parts of immature bitter orange, 350-450 parts of atractylodes, 350-450 parts of codonopsis, 350-450 parts of hawthorn, 150-250 parts of inula flower and 350-450 parts of dried tangerine peel.

[0014] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 300-350 parts of bupleurum, 300-350 parts of immature bitter orange, 380-420 parts of atractylodes, 380-420 parts of codonopsis, 380-420 parts of hawthorn, 180-220 parts of inula and 380-420 parts of dried tangerine peel.

[0015] More preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight: 313 parts of Bupleuri Radix, 313 parts of Aurantii Fructus Immaturus, 417 parts of Atractylodis Macrocephalae Rhizoma Praeparatum, 417 parts of Codonopsis Radix, 417 parts of Crataegi Fructus, 208 parts of Inulae Flos, and 417 parts of Citri Reticulatae Pericarpium.

[0016] Preferably, and as an example of the present invention, the Bupleuri Radix is Bupleuri Radix Borealis, and the Atractylodis Macrocephalae Rhizoma Praeparatum is Atractylodis Macrocephalae Rhizoma Praeparatum with bran.

[0017] On the other hand, the present invention provides a preparation method of the above traditional Chinese medicine composition, comprising the following steps:

[0018] Mix the raw materials with 4 - 11 times the weight of water, decoct for 0.5 - 1 h, repeat 1 - 2 times, and take the decoction to obtain the product.

[0019] Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0020] Mix the raw materials with 7 - 10 times the weight of water, decoct for 0.5 - 1 h, filter, add 4 - 7 times the weight of water based on the weight of the raw materials to the filter residue, decoct for 0.5 h, combine the decoctions obtained from the two decoctions to obtain the product.

[0021] As an example of the present invention, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0022] Mix the raw materials with 7 times the weight of water, decoct for 0.5 h, filter, add 4 times the weight of water based on the weight of the raw materials to the filter residue, decoct for 0.5 h, filter, combine the decoctions obtained from the two decoctions to obtain the product.

[0023] As an example of the present invention, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0024] Mix the raw materials with 7 times the weight of water, decoct for 1 h, filter, add 4 times the weight of water based on the weight of the raw materials to the filter residue, decoct for 0.5 h, filter, combine the decoctions obtained from the two decoctions to obtain the product.

[0025] As an example of the present invention, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0026] Mix the raw materials with 10 times the weight of water, decoct for 0.5 h, filter, add 7 times the weight of water based on the weight of the raw materials to the filter residue, decoct for 0.5 h, combine the decoctions obtained from the two decoctions to obtain the product.

[0027] As an example of the present invention, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0028] Mix the raw materials with 11 times the weight of water, decoct for 1 h, filter, and take the decoction to obtain the product.

[0029] In another aspect, the present invention provides a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method.

[0030] The drug can be prepared into dosage forms for administration such as pills, capsules, granules, oral liquids, powders, tablets, lozenges, troches, etc., and suitable pharmaceutical carriers in the art can be selected according to different dosage forms.

[0031] The pharmaceutical carriers used can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water.

[0032] When preparing a composition in an oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agents, preservatives, coloring agents, 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. Due to their ease of administration, tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers. Standard aqueous or non-aqueous techniques can be optionally used for coating tablets.

[0033] Tablets containing the traditional Chinese medicine composition of the present invention can be prepared by tabletting or molding, and one or more auxiliary components or adjuvants can be optionally used. Tablets can be prepared by tabletting the active ingredient in a free-flowing form (such as powder or granules) in a suitable machine, optionally mixed with binders, lubricants, inert diluents, surface-active substances or dispersants. Molded tablets can be molded in a suitable machine, i.e., a mixture of powdered compounds moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of the active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of the active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of the active drug, mixed with a suitable and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of the active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0034] The drug of the present invention can be in a form suitable for topical use, such as an aerosol, cream, ointment, lotion, powder or the like. In addition, the composition can be in a suitable form for a transdermal delivery device. These formulations can be prepared using the traditional Chinese medicine composition of the present invention by conventional processing methods. For example, a cream or ointment with the desired consistency is prepared by mixing a hydrophilic material and water, and about 5 wt% to about 10 wt% of the compound.

[0035] In addition to the above carrier components, the above pharmaceutical preparation may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients may be added, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., coloring agents and flavoring agents, etc. To make the preparation isotonic with the blood of the intended recipient. The components of the traditional Chinese medicine composition of the present invention may also be prepared in the form of powders or concentrates.

[0036] Preferably, the dosage form of the drug is selected from pills, capsules, granules, oral liquids, powders, tablets, lozenges.

[0037] Preferably, the pharmaceutical preparation is an oral pharmaceutical preparation.

[0038] More preferably, the oral pharmaceutical preparation is any one of decoctions, pills, tablets, capsules, powders, granules, oral liquids.

[0039] As an example of the present invention, the pharmaceutical preparation is granules.

[0040] As an example of the present invention, the preparation method of the granules includes the following steps:

[0041] Mix the raw medicinal materials with 7 times the weight of water, decoct for 0.5 h, filter the decoction, then add 4 times the weight of the raw medicinal materials of water, decoct for 0.5 h, filter the decoction, combine the two decoction filtrates, concentrate under reduced pressure to a clear paste with a relative density of 1.06 - 1.09 (60 °C), add dextrin, mix well, spray dry, then add dextrin, mix well, and make into granules to obtain.

[0042] Finally, the present invention provides the application of the above traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above preparation method or the above pharmaceutical preparation in the preparation of drugs for strengthening the spleen and stomach, regulating qi and relieving fullness.

[0043] Preferably, the drugs for strengthening the spleen and stomach, regulating qi and relieving fullness have one or more of the following effects:

[0044] (1) Promote gastric emptying;

[0045] (2) Promote small intestine propulsion;

[0046] (3) Promote the secretion of motilin;

[0047] (4) Promote the secretion of gastrin.

[0048] In the present invention, the information of the traditional Chinese medicinal materials used is as follows.

[0049] Hawthorn

[0050] [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).

[0051] [Origin] The ripe fruit of Crataegus pinnatifida, a plant of the genus Crataegus in the Rosaceae family.

[0052]

Original plant

[0053] 2. Hawthorn C. pinnatifida Bunge.

[0054] [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℃.

[0055]

Properties

[0056]

Functions and Indications

[0057] Atractylodes macrocephala

[0058] [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).

[0059] [Origin] The rhizome of Atractylodes macrocephala, a plant of the genus Atractylodes in the Asteraceae family.

[0060] [Original plant] Atractylodes macrocephala Koidz. [Atractylismacrocephala (Koidz.) Hand.-Mazz].

[0061]

Harvesting and Processing

[0062]

Properties

[0063]

Functions and Indications

[0064]

Processing

[0065] In an example of the present invention, bran-fried Atractylodes macrocephala is selected for the formula. The specific processing method of bran-fried Atractylodes macrocephala is as follows: Sprinkle wheat bran into a hot pan, heat it with medium heat. When the wheat bran starts to smoke, pour in the slices of Atractylodes macrocephala, stir-fry until the surface turns dark yellow and a fragrant smell emits, then take them out, sift off the wheat bran, and let it cool. Bran-fried Atractylodes macrocephala is more inclined to dispel dampness and promote diuresis.

[0066] Tangerine Peel

[0067]

Aliases

[0068]

Source

[0069]

Original Plant

[0070] 2. Citrus reticulata Blanco.

[0071]

Harvesting and Processing

[0072]

Properties

[0073]

Indications

[0074] Bupleurum Root

[0075]

Synonyms

[0076]

Source

[0077]

Original Plants

[0078] 1. Bupleurum chinense DC.

[0079] 2. Bupleurum scorzonerifolium Willd.

[0080]

Medicinal Materials

[0081] Radix Bupleuri. According to different characters, it is commonly known as "North Bupleurum" and "South Bupleurum" respectively.

[0082] North Bupleurum: The root is cylindrical or oblong, 6 - 15 cm long, 0.3 - 0.8 cm in diameter. The root head is enlarged, with 3 - 15 residual stem bases or short fibrous leaf bases at the top, and branched in the lower part. The surface is dark brown or light brown, with longitudinal wrinkles, lateral root scars and lenticels. It is hard and tough, not easily broken, with a fibrous cross-section, the cortex is light brown, and the xylem is yellowish-white. It has a slightly fragrant smell and a slightly bitter and pungent taste.

[0083] South Bupleurum: The root is thinner, conical, with many fine hairy withered leaf fibers at the top, and mostly unbranched or slightly branched in the lower part. The surface is reddish-brown or dark brown. There are many fine annular wrinkles near the root head. It is slightly soft, easily broken, with a slightly flat cross-section, not showing fibrousness, light brown, the cambium ring is slightly darker in color, and has an oily rancid smell.

[0084] In one example of the present invention, the Bupleurum used is North Bupleurum.

[0085]

Harvesting and Processing

[0086]

Properties

[0087]

Indications

[0088] Codonopsis Root

[0089] [Synonyms] Shangdang ginseng (Benjing Fengyuan), Huangshen, Fangdangshen, Shangdangshen (Baicaojing), Shitou ginseng (Gangmu Shiyi), Zhonglingcao (Qinghai Yaocai).

[0090] [Source] It is the root of Codonopsis pilosula, Codonopsis pilosula, Codonopsis pilosula, Codonopsis tubulosa, Codonopsis pilosula, and Codonopsis pilosula of the Campanulaceae family.

[0091]

Original Plant

[0092] 1. Codonopsispilosula(Franch.)Nannf.[Campanumoeapilosula Franch.].

[0093] 2. Codonopsis pilosula (Franch.) Nannf. var. modesta (Nannf.) LTShen.

[0094] 3. Codonopsis pilosula C.tangshen Oliv.

[0095] 4. C. tubulosa Kom.

[0096] 5. C. subglobosa WWSmith.

[0097] 6. C. canescens Nannf.

[0098] [Harvesting and processing] In September or October of the second or third year after transplanting, dig out the roots, dry them in the sun for 4-6 hours, tie them up with ropes, and rub them to make the roots full. After repeating this process 3-4 times, they can be tied into small bundles for storage or processing. During storage, they should be placed in a cool and dry place to avoid insect infestation.

[0099]

Properties

[0100] [Functions and indications] Strengthens the spleen and lungs, replenishes qi and produces body fluids. Indications: weak spleen and stomach, poor appetite and loose stools, fatigue in the limbs, cough and wheezing due to spleen deficiency, shortness of breath and spontaneous sweating, and deficiency of qi and blood.

[0101] Citrus aurantium

[0102] [Synonym] Goose-eye Citrus aurantium (Compendium of Materia Medica).

[0103] [Origin] The young fruit of the sour orange and its cultivated varieties or sweet orange of the genus Citrus in the Rutaceae family.

[0104]

Original Plant

[0105] 1. Citrus aurantium L..

[0106] 2. Sweet Orange, Citrus sinensis (L.) Osbeck.

[0107]

Harvesting and Processing

[0108]

Properties

[0109]

Functions and Indications

[0110] Inula flower

[0111]

Aliases

[0112]

Source

[0113]

Original Plants

[0114] 1. Inula japonica Thunb. [I. britannica L. var. japonica (Thunb.)

[0115] Franch. et Sav. ; I. britannica L. var. chinensis Regel].

[0116] 2. Inula britannica L.

[0117]

Harvesting and Processing

[0118]

Properties

[0119]

Functions and Indications

[0120] The beneficial effects of the present invention include:

[0121] (1) The traditional Chinese medicine composition of the present invention is properly formulated, and the functions of each raw material medicinal herb are combined. Bupleurum mainly enters the liver and gallbladder meridians, promotes the rising of yang qi, soothes the liver and relieves depression. Immature Bitter Orange regulates qi and relieves depression, purges heat and breaks stagnation. Together with Bupleurum, one rises and the other descends, promoting the ascending of clear qi and the descending of turbid qi, regulating qi and relieving distension. They are the monarch herbs in the formula. Atractylodes Macrocephala mainly enters the spleen and stomach meridians, strengthens the spleen and dries dampness. Codonopsis Pilosula tonifies the spleen and lungs, nourishes blood and promotes the production of body fluid, strengthening healthy qi and consolidating the root. They are the minister herbs. Hawthorn promotes digestion by strengthening the spleen. Inula britannica L. stops vomiting by descending adverse qi. Tangerine Peel regulates qi and strengthens the spleen. The three are used together as the assistant herbs. All the herbs are used together to achieve the effects of strengthening the spleen and stomach, regulating qi and relieving distension.

[0122] (2) It is confirmed by animal experiments that the traditional Chinese medicine composition of the present invention can effectively improve the gastric emptying rate of rats with functional dyspepsia (syndrome of spleen deficiency and qi stagnation), increase the small intestine propulsion rate of rats, and promote the secretion of MTL (motilin) and GAS (gastrin) in rats with spleen deficiency and dampness stagnation.

[0123] (3) The selected materials of the traditional Chinese medicine composition of the present invention are not extremely potent. It is confirmed by clinical observation and animal acute toxicity tests that the traditional Chinese medicine preparation has no obvious toxic and side effects. Detailed implementation modes

[0124] The following non-limiting examples can enable those of ordinary skill in the art to understand the present invention more comprehensively, but do not limit the present invention in any way. The following content is only an exemplary illustration of the scope claimed by the present invention. Those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and they should also fall within the scope claimed by the present invention.

[0125] The present invention will be further described below by way of specific examples. All kinds of chemical reagents 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 mass contents. Unless otherwise specified, it is understood that the operations are carried out at room temperature.

[0126] Examples 1 - 5 provide traditional Chinese medicine compositions, and their ingredients and parts by weight are shown in Table 1 (unit: part by weight).

[0127] Table 1

[0128] Group Example 1 Example 2 Example 3 Example 4 Example 5 Bupleurum chinense DC. 313 300 350 300 400 Fructus Aurantii Immaturus 313 350 300 400 300 Atractylodes macrocephala Koidz. stir-fried with bran 417 380 420 350 450 Codonopsis pilosula (Franch.) Nannf. 417 420 380 450 350 Fructus Crataegi 417 380 420 350 450 Flos Inulae 208 220 180 250 150 Pericarpium Citri Reticulatae 417 380 420 350 450

[0129] Comparative Examples 1 - 6 provide traditional Chinese medicine compositions, and their ingredients and parts by weight are shown in Table 2 (unit: part by weight, "-" indicates that the component is not contained).

[0130] Table 2

[0131] Group Control Example 1 Control Example 2 Control Example 3 Control Example 4 Control Example 5 Control Example 6 Bupleurum chinense DC. 275 313 - 626 313 313 Fructus Aurantii Immaturus 330 313 626 - 313 313 Atractylodes macrocephala Koidz. stir-fried with bran 550 417 417 417 417 417 Codonopsis pilosula (Franch.) Nannf. 417 417 417 417 417 417 Fructus Crataegi 275 417 417 417 417 417 Flos Inulae 208 - 208 208 - - Pericarpium Citri Reticulatae 417 417 417 417 417 625 Pinellia ternata (Thunb.) Breit. - 208 - - - - Herba Pogostemonis - - - - 208 -

[0132] Comparative Example 7

[0133] The spleen - strengthening and turbidity - removing formula has the following components by weight.

[0134] 15 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 10 parts of Fructus Aurantii Immaturus, 10 parts of Dioscorea opposita, 10 parts of Fructus Aurantii, 10 parts of Pinellia ternata, 10 parts of Bupleurum chinense, 9 parts of Rheum palmatum, 9 parts of Citrus reticulata Blanco, 3 parts of Radix Glycyrrhizae Preparata.

[0135] Preparation Example 1

[0136] Preparation method of the traditional Chinese medicine composition.

[0137] Weigh a total of 144.25 g of the raw materials according to the weight ratio of Example 1, add 7 times the weight of water (1009.75 g), decoct for 0.5 h, and filter the decoction. Then add 4 times the weight of water (577 g) of the traditional Chinese medicine composition, decoct for 0.5 h, filter, and combine the two decoction filtrates to obtain a solution. Measure the volume (mL) and solid content (g / mL) of the above - mentioned solution.

[0138] Preparation Example 2

[0139] Preparation method of the traditional Chinese medicine composition.

[0140] Weigh a total of 144.19 g of the raw materials according to the weight ratio of Example 1, add 7 times the weight of water (1009.33 g), decoct for 1 h, and filter the decoction. Then add 4 times the weight of water (576.76 g) of the traditional Chinese medicine composition, decoct for 0.5 h, filter, and combine the two decoction filtrates to obtain a solution. Measure the volume (mL) and solid content (g / mL) of the above - mentioned solution.

[0141] Preparation Example 3

[0142] Weigh a total of 144.15 g of the raw materials according to the weight ratio of Example 1, add 10 times the weight of water (1441.5 g), decoct for 0.5 h, and filter the decoction. Then add 7 times the weight of water (1009.05 g) of the traditional Chinese medicine composition, decoct for 0.5 h, filter, and combine the two decoction filtrates to obtain a solution. Measure the volume (mL) and solid content (g / mL) of the above - mentioned solution.

[0143] Preparation Example 4

[0144] Weigh a total of 144.19 g of the raw materials according to the weight ratio of Example 1, add 11 times the weight of water (1441.5 g), decoct for 1 h, filter the decoction to obtain a solution. Measure the volume (mL) and solid content (g / mL) of the above - mentioned solution.

[0145] The detection method of the solid content is as follows: Take a certain volume of the solution, dry it thoroughly to obtain the solid. Solid content (g / mL)=mass of solid (g)÷volume of solution (mL).

[0146] Using the weights of the active pharmaceutical ingredients, solution volumes, and solid contents in Preparation Examples 1 - 4, the paste yield was calculated.

[0147] Paste yield (%) = Solid content (g / mL) × Solution volume (mL) ÷ Weight of active pharmaceutical ingredient (g) × 100%.

[0148] Meanwhile, according to the content determination method under Fructus Aurantii Immaturus in the first part of Chinese Pharmacopoeia (2020 Edition), the content of synephrine in the solid was detected. The characterization experimental results of Preparation Examples 1 - 4 are shown in Table 3 below.

[0149] Table 3

[0150]

[0151] Note: Comprehensive score = Paste yield ÷ Maximum paste yield among 4 groups of preparation examples × 50% + Synephrine content ÷ Maximum synephrine content among 4 groups of preparation examples × 50%.

[0152] The inventors unexpectedly found that when using the method of Preparation Example 2 to prepare the traditional Chinese medicine composition, the first decoction time was 30 minutes longer than that of Preparation Example 1. However, the synephrine content in the solid obtained by the method of Preparation Example 1 was higher than that of Preparation Example 2. This may be because the synephrine content is greatly affected by the decoction time. If the decoction time is too long, synephrine will be partially decomposed, resulting in the loss of this substance.

[0153] Preparation Example 5

[0154] A preparation method of granules.

[0155] Add 7 times the weight of water to the traditional Chinese medicine composition and decoct for 0.5 h, then filter the decoction. Then add 4 times the weight of water of the traditional Chinese medicine composition and decoct for 0.5 h, filter the decoction, combine the two decoction filtrates, concentrate under reduced pressure to a clear paste with a relative density of 1.06 - 1.09 (60 °C), add dextrin, and the addition amount is 5% of the total weight of the active pharmaceutical ingredient. Mix well, spray dry, then add 1% - 5% of dextrin based on the total weight of the raw materials, mix well, and make into granules to obtain the product.

[0156] Effect evaluation

[0157] Using the method of functional dyspepsia combined with spleen injury due to overwork, a rat model of functional dyspepsia (syndrome of qi stagnation due to spleen deficiency) was constructed, and the specific method is as follows.

[0158] After adaptive feeding of the animals, 7-day-old SD suckling rats were randomly divided into a blank control group and a model group. The blank control group was intragastrically administered 2% sucrose solution (0.2 mL / rat), and the model group was intragastrically administered 0.1% iodoacetamide sucrose solution (0.2 mL / rat), once a day for 6 consecutive days. During the modeling period, the mother rats nursed the pups normally. The rats were normally raised until they were weaned at 3 weeks of age and then caged separately. When the rats reached 6 weeks of age, the rats in the model group were subjected to chronic fatigue exercise and irregular feeding. The rats were forced to perform fatigue exercise on a rotarod fatigue tester once in the morning and once in the afternoon every day, 60 minutes each time, for 14 consecutive days. During this period, the rats in the model group were subjected to irregular diet stimulation of fasting without water restriction on odd days and sufficient food and water supply on even days. The rats in the blank control group were raised in the conventional manner and given sufficient food and water every day. The modeling was terminated at 8 weeks of age. The rats in the model group showed manifestations such as reduced activity, lying lethargically with little movement, slow reaction, dull and disordered hair, soft stools, and less food intake, indicating successful modeling.

[0159] The successfully modeled rats were randomly divided into a model group, a drug administration group, and a positive control group, with 6 rats in each group. The positive control group was intragastrically administered domperidone at a dose of 3 mg / kg, and each drug administration group was intragastrically administered the corresponding drug (calculated as the raw drug) at a dose of 6 g / kg. The administration volume was 20 mL / kg of the rat body weight. The blank control group and the model group were intragastrically administered an equal volume of distilled water, once a day for 2 consecutive weeks.

[0160] The drug types administered to each drug administration group were as follows:

[0161] For each example and comparative example group: The traditional Chinese medicine compositions provided in each example and comparative example were successively prepared into granules by the method provided in Preparation Example 5. Before intragastric administration, the granules were mixed with an appropriate amount of distilled water according to the dosage (calculated as the raw drug) and administration volume to prepare a solution with the required concentration, and then intragastric administration could be carried out.

[0162] After the last administration, the rats in each group were fasted without water restriction for 24 hours, and then intragastrically administered 0.3 mL / 100 g of semi-solid nutrient paste containing carbon powder. After 30 minutes, the rats were sacrificed. Blood was collected from the abdominal aorta and centrifuged at 3000 r / min for 10 minutes to obtain serum. The expressions of MTL (motilin) and GAS (gastrin) were detected by ELISA. The cardia and pylorus of the rats were ligated with medical silk thread, and the whole stomach was excised and weighed. The gastric body was cut open, and the gastric contents were rinsed with normal saline, and then the net weight of the stomach was weighed. The intestinal tract from the pylorus to the ileum was excised, laid flat without traction, and the advancing distance and total length of the nutrient paste were measured and recorded.

[0163] Gastric emptying rate = 1 - (total gastric weight - net gastric weight) / semi-solid paste × 100%.

[0164] Small intestine propulsion rate = length of nutrient paste propulsion / total length of small intestine (from pylorus to ileocecal junction) × 100%.

[0165] The experimental results of the gastric emptying rate and small intestine propulsion rate of rats are shown in Table 4 as follows:

[0166] Table 4

[0167] Group Gastric emptying rate (%) Intestinal propulsion rate (%) Blank control group 61.75±6.15 73.41±5.92 Model group <![CDATA[39.25±5.36 ** > <![CDATA[51.26±6.64 ** > Positive control group <![CDATA[56.73±5.57 ## > <![CDATA[65.75±5.47 ## > Example 1 group <![CDATA[55.06±5.19 ## > <![CDATA[66.12±5.89 ## > Example 2 group <![CDATA[52.47±5.34 ## > <![CDATA[64.58±6.36 ## > Example 3 group <![CDATA[52.93±5.28 ## > <![CDATA[63.95±6.04 ## > Example 4 group <![CDATA[50.61±4.67 ## > <![CDATA[62.03±5.61 ## <!-- 9 -->]]> Example 5 group <![CDATA[51.09±4.71 ## > <![CDATA[62.71±5.55 ## > Control Example 1 group <![CDATA[48.82±5.02 #△ > <![CDATA[60.65±5.17 #△ > Control Example 2 group <![CDATA[45.39±4.37 #△ > <![CDATA[60.52±6.18 #△ > Control Example 3 group <![CDATA[43.80±4.09 #△ > <![CDATA[59.22±5.39 #△ > Control Example 4 group <![CDATA[43.96±4.84 #△ > <![CDATA[58.94±6.41 #△ > Control Example 5 group <![CDATA[45.50±4.16 #△ > <![CDATA[60.38±5.20 #△ > Control Example 6 group <![CDATA[44.64±5.11 #△ > <![CDATA[59.80±5.46 #△ > Control Example 7 group <![CDATA[49.35±5.08 ##△ > <![CDATA[60.97±6.52 #△ >

[0168] Note: Compared with the blank control group, ** P < 0.01; compared with the model group ## P < 0.01, # P < 0.05; compared with the Example 1 group, △ P < 0.05.

[0169] The detection results of motilin and gastrin in rats are shown in Table 5 as follows:

[0170] Table 5

[0171] Group MTL (ng / L) GAS (ng / mL) Blank control group 273.32±34.72 339.35±30.69 Model group <![CDATA[159.67±23.99 ** > <![CDATA[179.51±15.77 ** > Positive control group <![CDATA[233.06±21.52 # > <![CDATA[294.93±22.13 # > Example 1 group <![CDATA[234.58±26.15 # > <![CDATA[306.65±23.90 # > Example 2 group <![CDATA[222.33±27.11 # > <![CDATA[278.37±20.54 # > Example 3 group <![CDATA[225.24±28.03 # > <![CDATA[275.16±20.28 # > Example 4 group <![CDATA[216.27±21.34 # > <![CDATA[257.68±19.85 # > Example 5 group <![CDATA[219.16±21.48 # > <![CDATA[255.77±19.71 # > Control Example 1 group <![CDATA[184.42±21.76 #△ > <![CDATA[233.65±18.81 #△ > Control Example 2 group <![CDATA[179.81±20.10 △ > <![CDATA[227.18±18.39 △ > Control Example 3 group <![CDATA[165.54±19.63 △ > <![CDATA[216.74±18.14 △ > Control Example 4 group <![CDATA[166.12±20.26 △ > <![CDATA[213.86±18.36 △ > Control Example 5 group <![CDATA[176.94±20.59 △ > <![CDATA[225.26±18.66 △ > Control Example 6 group <![CDATA[170.62±20.97 △ > 222.57±18.21△ Control Example 7 group <![CDATA[196.05±22.09 #△ > <![CDATA[241.20±19.57 #△ >

[0172] Note: Compared with the blank control group, ** P < 0.01; compared with the model group # P < 0.05; compared with the Example 1 group, △ P < 0.05.

[0173] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than limiting the protection scope of the present invention. Any simple modification or equivalent replacement made by those of ordinary skill in the art to the technical solution of the present invention shall not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for strengthening the spleen and stomach, regulating qi and eliminating abdominal distension, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 300-400 parts of bupleurum, 300-400 parts of immature bitter orange, 350-450 parts of atractylodes, 350-450 parts of codonopsis, 350-450 parts of hawthorn, 150-250 parts of inula and 350-450 parts of dried tangerine peel.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 300-350 parts of bupleurum, 300-350 parts of immature bitter orange, 380-420 parts of atractylodes, 380-420 parts of codonopsis, 380-420 parts of hawthorn, 180-220 parts of inula and 380-420 parts of dried tangerine peel.

3. The Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 313 parts of bupleurum, 313 parts of immature bitter orange, 417 parts of atractylodes, 417 parts of codonopsis, 417 parts of hawthorn, 208 parts of inula and 417 parts of dried tangerine peel.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The bupleurum is northern bupleurum, and the atractylodes is fried atractylodes with bran.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: Mix the raw material with 4-11 times its weight of water, boil for 0.5-1h, repeat 1-2 times, and take the decoction to obtain the product.

6. The preparation method according to claim 5, characterized in that: The following steps are involved: Mix the raw material drug with 7-10 times the weight of water, boil for 0.5-1h, filter, add 4-7 times the weight of water to the residue, boil for 0.5h, combine the decoctions obtained from the two decoctions, and obtain the product.

7. A pharmaceutical preparation, characterized in that A Chinese medicine composition comprising the Chinese medicine composition described in any one of claims 1-4 or a Chinese medicine composition prepared by the preparation method described in any one of claims 5-6.

8. The pharmaceutical preparation according to claim 7, characterized in that The dosage form of the drug is selected from pills, capsules, granules, oral liquids, powders, tablets, and lozenges.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 6, or the pharmaceutical preparation according to any one of claims 7 to 8 in the preparation of medicines for strengthening the spleen and stomach, regulating qi and eliminating abdominal distension.

10. The use according to claim 9, characterized in that: The medicine for strengthening the spleen and stomach, regulating qi and eliminating abdominal distension has one or more of the following effects: (1) Promote gastric emptying; (2) Promote small intestinal propulsion; (3) Promote the secretion of motilin; (4) Promote the secretion of gastrin.

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