Traditional Chinese medicine composition for treating spleen and stomach disharmony and preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly discloses a traditional Chinese medicine composition for treating spleen and stomach disharmony and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 to 30 parts of cortex magnoliae officinalis, 12 to 18 parts of rhizoma atractylodis macrocephalae, 15 to 25 parts of fructus aurantii immaturus, 5 to 15 parts of radix codonopsis, 8 to 20 parts of radix angelicae sinensis, 2 to 10 parts of cortex cinnamomi, 10 to 18 parts of pericarpium citri reticulatae, 10 to 18 parts of fructus crataegi, 25 to 35 parts of folium nelumbinis, 10 to 15 parts of sticktight and 1 to 5 parts of fructus gardeniae. The preparation method of the traditional Chinese medicine composition comprises the following steps: performing alcohol extraction on cortex magnoliae officinalis, rhizoma atractylodis macrocephalae, fructus aurantii immaturus, radix codonopsis, radix angelicae sinensis, cortex cinnamomi and pericarpium citri reticulatae to obtain an extracting solution; performing enzymolysis on hawthorn, lotus leaf, spanishneedles herb and gardenia to obtain enzymatic hydrolysate; and mixing the extracting solution and the enzymatic hydrolysate, concentrating and drying. The preparation method is simple in steps and low in cost, and the obtained traditional Chinese medicine composition is remarkable in treatment effect on spleen and stomach disharmony, small in side effect and wide in market prospect.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and more specifically, relates to a traditional Chinese medicine composition for treating spleen and stomach disharmony, and a preparation method and use thereof. Background Art

[0002] Inharmonious spleen and stomach is a common syndrome in traditional Chinese medicine, which is mainly manifested by loss of appetite, small appetite, poor digestion, bloating and fullness after eating, belching and acid regurgitation. These symptoms seriously affect the patient's quality of life and may lead to a series of health problems such as malnutrition and decreased immunity. Clinically, it is often manifested as functional dyspepsia and postprandial discomfort syndrome.

[0003] In traditional Chinese medicine theory, the spleen and stomach are the foundation of the acquired constitution, responsible for transporting and transforming the essence of water and grain, and are the source of the body's qi and blood. Spleen and stomach disharmony is often caused by factors such as improper diet, emotional disorders, and improper work and rest, which lead to impaired spleen and stomach function, and then digestion and absorption disorders. Traditional Chinese medicine compositions for treating spleen and stomach disharmony are usually formulated according to the principles of strengthening the spleen and stomach, digesting food and eliminating accumulation, and promoting qi and removing stagnation, so as to achieve the purpose of restoring spleen and stomach function and improving digestion and absorption.

[0004] At present, there are many Chinese medicine preparations for treating spleen and stomach disharmony on the market, but the efficacy varies. For example, CN118557673A discloses a Chinese medicine preparation for improving gastrointestinal digestive function, which includes the following raw materials in parts by weight: 20-30 parts of Trichosanthes fruit, 18-25 parts of Hibiscus flower, 8-15 parts of stir-fried Citrus aurantium, 5-10 parts of Ramie root, 5-10 parts of Elm leaf, 3-8 parts of Papaya, 4-6 parts of malt sprout, 4-6 parts of Codonopsis pilosula, and 1-3 parts of roasted Licorice root. The Chinese medicine preparation can promote gastrointestinal motility and improve constipation symptoms to a certain extent; however, it is still insufficient in regulating postprandial discomfort syndrome of functional dyspepsia of spleen and stomach disharmony type.

[0005] Therefore, the present application proposes a Chinese medicine composition with more precise medication and better effect for treating the symptoms of spleen and stomach disharmony. Summary of the invention

[0006] In order to solve the problem that existing drugs for treating spleen and stomach disharmony are not effective, the present application provides a traditional Chinese medicine composition for treating spleen and stomach disharmony, and a preparation method and use thereof.

[0007] In the first aspect, the present application provides a Chinese medicine composition for treating spleen and stomach disharmony, using the following technical solution:

[0008] A traditional Chinese medicine composition for treating spleen and stomach disharmony comprises the following raw materials in parts by weight: 20-30 parts of magnolia bark, 12-18 parts of atractylodes macrocephala, 15-25 parts of immature bitter orange, 5-15 parts of codonopsis pilosula, 8-20 parts of angelica sinensis, 2-10 parts of cinnamon bark, 10-18 parts of tangerine peel, 10-18 parts of hawthorn, 25-35 parts of lotus leaf, 10-15 parts of bidens pilosa, and 1-5 parts of gardenia.

[0009] Preferably, the Chinese medicine composition for treating spleen and stomach disharmony comprises the following raw materials in parts by weight: 25 parts of Magnolia officinalis, 15 parts of Atractylodes macrocephala, 20 parts of Citrus aurantium, 10 parts of Codonopsis pilosula, 10 parts of Angelica sinensis, 8 parts of cinnamon bark, 15 parts of dried tangerine peel, 15 parts of hawthorn, 30 parts of lotus leaf, 12 parts of Bidens pilosa, and 2 parts of Gardenia jasminoides.

[0010] In a second aspect, the present application provides a method for preparing a Chinese medicine composition for treating spleen and stomach disharmony, using the following technical scheme:

[0011] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0012] S1, extracting Magnolia officinalis, Atractylodes macrocephala, Citrus aurantium immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, and Tangerine peel with alcohol to obtain an extract;

[0013] S2, enzymatically hydrolyzing the hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to obtain an enzymatic hydrolyzate;

[0014] S3, mixing the extract and the enzymatic hydrolysate, concentrating and drying.

[0015] Preferably, the alcohol extraction in S1 comprises adding Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, performing a first alcohol extraction at 60-70°C for 2-4h, filtering to obtain a medicinal solution and a medicinal residue; adding the remaining Magnolia officinalis and ethanol to the medicinal residue, performing a second alcohol extraction at 60-70°C for 1-3h, filtering, and combining the extracted medicinal solutions to obtain an extract.

[0016] Preferably, the mass of ethanol during the first alcohol extraction is 7-10 times the total mass of Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol during the second alcohol extraction is 4-6 times the total mass of the residues and the remaining Magnolia officinalis.

[0017] Preferably, the mass ratio of the partial Magnolia officinalis to the remaining Magnolia officinalis is 1:2-4.

[0018] Preferably, the enzymatic hydrolysis in S2 comprises adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to an enzyme solution, adjusting the pH to 6-7, enzymatically hydrolyzing at 30-45° C. for 1-2 h, boiling, inactivating, filtering, and obtaining an enzymatic hydrolyzate.

[0019] Preferably, the mass of the enzyme solution is 4-6 times the total mass of hawthorn, lotus leaf, bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3-7:1-8:100.

[0020] In a third aspect, the present application provides a use of the above-mentioned traditional Chinese medicine composition, namely, use of the traditional Chinese medicine composition in the preparation of a medicine for treating spleen and stomach disharmony.

[0021] Preferably, the dosage form of the drug includes one of pills, powders, powders, tablets, pastes, capsules, granules, oral liquids, and Chinese medicine decoctions.

[0022] Preferably, the drug further comprises pharmaceutically acceptable excipients.

[0023] The pharmacological and medicinal properties of the raw materials used in this application are analyzed as follows:

[0024] Magnolia officinalis: [Nature and flavor] Bitter, pungent, warm, and enters the spleen, stomach, lung, and large intestine meridians. [Pharmacological properties] Magnolia officinalis has the effects of drying dampness and eliminating phlegm, and removing qi and distension. It can treat symptoms such as dampness blocking the middle jiao, abdominal distension, food accumulation and qi stagnation, and has significant therapeutic effects on abdominal distension and indigestion caused by spleen and stomach disharmony. In addition, Magnolia officinalis also has antibacterial, ulcer prevention and treatment, and blood pressure reduction effects, which helps to improve inflammation and high blood pressure caused by spleen and stomach disharmony.

[0025] Atractylodes macrocephala: [Nature and flavor] Bitter, sweet, warm, and enters the spleen and stomach meridians. [Pharmacological properties] Atractylodes macrocephala can nourish the spleen and replenish qi, dry dampness and promote diuresis, and strengthen the exterior and stop sweating. It is mainly used to treat symptoms such as spleen and stomach weakness, indigestion, loss of appetite, vomiting and diarrhea, and can enhance spleen and stomach function and improve digestion and absorption capacity. The drying effect of Atractylodes macrocephala can also eliminate excess water in the body and improve symptoms such as edema and difficulty urinating.

[0026] Citrus aurantium: [Nature and flavor] Bitter, pungent, sour, warm, and enters the spleen and stomach meridians. [Pharmacological properties] Citrus aurantium has the effects of breaking up qi and eliminating stagnation, resolving phlegm and dispersing lumps. It can treat symptoms such as food stagnation and abdominal distension, and has a significant effect on abdominal distension and lumps caused by spleen and stomach disharmony. In addition, Citrus aurantium can also treat gastroptosis, uterine prolapse, etc., and has a certain effect on improving spleen and stomach function.

[0027] Codonopsis: [Nature and flavor] Sweet, neutral, enters the spleen and lung meridians. [Pharmacological properties] Codonopsis has the effects of nourishing blood and promoting body fluid, nourishing the lungs and spleen. It can regulate gastrointestinal motility and enhance immune function. It has a therapeutic effect on symptoms such as fatigue and weakness caused by spleen and stomach weakness and deficiency of both qi and blood, and decreased appetite. The tonic effect of Codonopsis helps to restore the normal function of the spleen and stomach.

[0028] Angelica: [Nature and flavor] Sweet, pungent, warm, and enters the liver, heart, and spleen meridians. [Pharmacological properties] Angelica has the effects of nourishing blood, activating blood circulation, regulating menstruation and relieving pain. Although Angelica is mainly used to treat gynecological diseases, its effect of nourishing blood and activating blood circulation can also help improve the symptoms of qi and blood deficiency and blood stasis caused by spleen and stomach disharmony.

[0029] Cinnamon: [Nature and flavor] Spicy, sweet, very hot, it enters the kidney, spleen, heart, and liver meridians. [Pharmacological properties] Cinnamon can replenish fire and yang, dispel cold and relieve pain, and warm and dredge the meridians. It has a certain therapeutic effect on abdominal pain, diarrhea and other symptoms caused by spleen and stomach deficiency and cold. Cinnamon's warming effect helps to enhance the yang of the spleen and stomach and improve the symptoms of deficiency and cold caused by spleen and stomach disharmony.

[0030] Tangerine peel: [Nature and flavor] Bitter, pungent, warm, and enters the spleen and lung meridians. [Pharmacological properties] Tangerine peel has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It can treat spleen and stomach qi stagnation syndrome, such as abdominal distension, loss of appetite, vomiting and diarrhea, and has a significant effect on abdominal distension and indigestion caused by spleen and stomach disharmony. The qi-regulating effect of tangerine peel helps to restore the qi movement of the spleen and stomach.

[0031] Hawthorn: [Nature and flavor] Sour, sweet, slightly warm, and enters the spleen, stomach, and liver meridians. [Pharmacological properties] Hawthorn can help digestion, resolve stagnation, and promote qi and dissipate blood stasis. It is mainly used to treat symptoms such as meat stagnation and stomach distension. It has a significant effect on indigestion and abdominal distension caused by spleen and stomach disharmony. Hawthorn's digestive effect helps improve the digestive function of the spleen and stomach.

[0032] Lotus leaf: [Nature and flavor] Bitter, neutral, enters the liver, spleen, and stomach meridians. [Pharmacological properties] Lotus leaf has the effects of clearing away heat and dampness, promoting the clear yang, cooling blood and stopping bleeding. It is mainly used to treat symptoms such as summer heat and thirst, summer dampness and diarrhea. Although lotus leaf is not the main medicine for treating spleen and stomach disharmony, its effect of clearing away heat and dampness helps to improve the damp-heat symptoms caused by spleen and stomach disharmony.

[0033] Bidens pilosa: [Nature and flavor and meridians] Bitter, slightly cold (or neutral), liver, lung, large intestine (or spleen, stomach) meridians. [Pharmacological properties] Bidens pilosa has the effects of clearing away heat and detoxifying, dispersing blood stasis and reducing swelling. Although it is mainly used to treat symptoms such as upper respiratory tract infections and sore throats, modern studies have shown that Bidens pilosa also has anti-inflammatory and antibacterial effects, and has a certain auxiliary therapeutic effect on inflammation caused by spleen and stomach disharmony.

[0034] Gardenia: [Nature and flavor] Bitter, cold, heart, lung, triple burner meridians. [Pharmacological properties] Gardenia has the effects of purging fire and relieving restlessness, clearing heat and removing dampness, cooling blood and detoxifying. It is mainly used to treat symptoms such as restlessness due to fever, damp-heat jaundice, and bloody stranguria. The heat-clearing and damp-removing effects of Gardenia help improve damp-heat symptoms caused by spleen and stomach disharmony, such as bitter taste in the mouth, dry mouth, and sticky stools.

[0035] In summary, this application has the following beneficial effects:

[0036] This application combines the medicinal materials according to the principle of monarch, minister, assistant and envoy, with Magnolia officinalis and Atractylodes macrocephala as the monarch medicines, Citrus aurantium, Codonopsis pilosula and Crataegus pinnatifida as minister medicines, Tangerine peel, cinnamon bark, lotus leaf and Bidens pilosa as adjuvant medicines, and Angelica sinensis and Gardenia jasminoides as envoy medicines. The composed Chinese herbal prescription can work synergistically, has a reasonable formula, and has few side effects. It can regulate spleen and stomach disharmony and effectively treat functional dyspepsia and postprandial discomfort syndrome.

[0037] This application further studies the preparation method of the Chinese medicine composition, discovers the key process parameters for extracting medicinal materials, and obtains an optimal preparation process: first, Atractylodes macrocephala, Codonopsis pilosula, Angelica sinensis, cinnamon bark, tangerine peel and Magnolia officinalis are subjected to secondary alcohol extraction, and then hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides are extracted by enzyme. The Chinese medicine composition prepared by this method is effective in improving spleen and stomach disharmony. DETAILED DESCRIPTION

[0038] The present application is further described in detail below with reference to the embodiments.

[0039] Embodiment 1-3 provides a Chinese medicine composition for treating spleen and stomach disharmony and a preparation method thereof.

[0040] Example 1

[0041] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 20 parts of Magnolia officinalis, 12 parts of Atractylodes macrocephala, 15 parts of Citrus aurantium, 5 parts of Codonopsis pilosula, 8 parts of Angelica sinensis, 2 parts of Cinnamon bark, 10 parts of Tangerine peel, 10 parts of Crataegus pinnatifida, 25 parts of Lotus leaf, 10 parts of Bidens pilosa, and 1 part of Gardenia jasminoides;

[0042] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0043] S1. Add Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, perform a first alcohol extraction at 60° C. for 2 h, and filter to obtain a medicinal solution and a medicinal residue; add the remaining Magnolia officinalis and ethanol to the medicinal residue, perform a second alcohol extraction at 60° C. for 1 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0044] The mass of ethanol in the first alcohol extraction is 7 times the total mass of Atractylodes macrocephala, Citrus aurantium, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the first alcohol extraction is 4 times the total mass of the residue and the remaining Magnolia officinalis; the mass ratio of part of Magnolia officinalis to the remaining Magnolia officinalis is 1:2;

[0045] S2, adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to the enzyme solution, adjusting the pH to 6, performing enzymolysis at 30°C for 1 hour, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0046] The mass of the enzyme solution is 4 times the total mass of hawthorn, lotus leaf, Bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3:2:100;

[0047] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.1, and vacuum dry to obtain.

[0048] Example 2

[0049] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 25 parts of magnolia bark, 15 parts of atractylodes macrocephala, 20 parts of eucommia bark, 10 parts of codonopsis pilosula, 10 parts of angelica sinensis, 8 parts of cinnamon bark, 15 parts of tangerine peel, 15 parts of hawthorn, 30 parts of lotus leaf, 12 parts of bidens pilosa, and 2 parts of gardenia;

[0050] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0051] S1. Add Atractylodes macrocephala, Eucommia ulmoides, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, perform the first alcohol extraction at 65° C. for 3 h, and filter to obtain a medicinal solution and a medicinal residue; add the remaining Magnolia officinalis and ethanol to the medicinal residue, perform the second alcohol extraction at 65° C. for 2 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0052] The mass of ethanol in the first alcohol extraction is 8 times the total mass of Atractylodes macrocephala, Eucommia ulmoides, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the first alcohol extraction is 5 times the total mass of the residue and the remaining Magnolia officinalis; the mass ratio of part of Magnolia officinalis to the remaining Magnolia officinalis is 1:3;

[0053] S2, adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to the enzyme solution, adjusting the pH to 6.5, performing enzymolysis at 40°C for 1.5h, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0054] The mass of the enzyme solution is 5 times the total mass of hawthorn, lotus leaf, Bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:7:1:100;

[0055] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.15, and vacuum dry to obtain.

[0056] Example 3

[0057] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 30 parts of magnolia bark, 18 parts of atractylodes macrocephala, 25 parts of eucommia bark, 15 parts of codonopsis pilosula, 20 parts of angelica sinensis, 10 parts of cinnamon bark, 18 parts of tangerine peel, 18 parts of hawthorn, 35 parts of lotus leaf, 15 parts of bidens pilosa, and 5 parts of gardenia;

[0058] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0059] S1. Add Atractylodes macrocephala, Eucommia ulmoides, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, perform a first alcohol extraction at 70° C. for 4 h, and filter to obtain a medicinal solution and a medicinal residue; add the remaining Magnolia officinalis and ethanol to the medicinal residue, perform a second alcohol extraction at 70° C. for 3 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0060] The mass of ethanol in the first alcohol extraction is 10 times the total mass of Atractylodes macrocephala, Eucommia ulmoides, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the first alcohol extraction is 6 times the total mass of the residue and the remaining Magnolia officinalis; the mass ratio of part of Magnolia officinalis to the remaining Magnolia officinalis is 1:4;

[0061] S2, adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to the enzyme solution, adjusting the pH to 7, performing enzymolysis at 45°C for 2h, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0062] The mass of the enzyme solution is 6 times the total mass of hawthorn, lotus leaf, Bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3:8:100;

[0063] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.2, and vacuum dry to obtain.

[0064] In order to verify the comprehensive performance of the Chinese medicine composition for treating spleen and stomach disharmony prepared in Examples 1-3 of the present application, the applicant set up comparative examples 1-4, which are as follows:

[0065] Comparative Example 1

[0066] Comparative Example 1 is different from Example 1 only in that Bidens pilosa L. is used to replace Fructus Aurantii Immaturus with an equal mass, as follows:

[0067] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 20 parts of magnolia bark, 12 parts of atractylodes macrocephala, 5 parts of codonopsis pilosula, 8 parts of angelica sinensis, 2 parts of cinnamon bark, 10 parts of tangerine peel, 10 parts of hawthorn, 25 parts of lotus leaf, 25 parts of bidens pilosa, and 1 part of gardenia;

[0068] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0069] S1. Add Atractylodes macrocephala, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, perform a first alcohol extraction at 60° C. for 2 h, and filter to obtain a medicinal solution and a medicinal residue; add the remaining Magnolia officinalis and ethanol to the medicinal residue, perform a second alcohol extraction at 60° C. for 1 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0070] The mass of ethanol in the first alcohol extraction was 7 times the total mass of Atractylodes macrocephala, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the second alcohol extraction was 4 times the total mass of the residue and the remaining Magnolia officinalis; the mass ratio of part of Magnolia officinalis to the remaining Magnolia officinalis was 1:2;

[0071] S2, adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to the enzyme solution, adjusting the pH to 6, performing enzymolysis at 30°C for 1 hour, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0072] The mass of the enzyme solution is 4 times the total mass of hawthorn, lotus leaf, Bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3:2:100;

[0073] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.1, and vacuum dry to obtain.

[0074] Comparative Example 2

[0075] Comparative Example 2 is different from Example 1 only in that the same mass of Citrus aurantium is used to replace Bidens pilosa, as follows:

[0076] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 20 parts of Magnolia officinalis, 12 parts of Atractylodes macrocephala, 25 parts of Citrus aurantium, 5 parts of Codonopsis pilosula, 8 parts of Angelica sinensis, 2 parts of Cinnamon bark, 10 parts of Tangerine peel, 10 parts of Crataegus pinnatifida, 25 parts of Lotus leaf, and 1 part of Gardenia jasminoides;

[0077] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0078] S1. Add Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, perform a first alcohol extraction at 60° C. for 2 h, and filter to obtain a medicinal solution and a medicinal residue; add the remaining Magnolia officinalis and ethanol to the medicinal residue, perform a second alcohol extraction at 60° C. for 1 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0079] The mass of ethanol in the first alcohol extraction is 7 times the total mass of Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the second alcohol extraction is 4 times the total mass of the residue and the remaining Magnolia officinalis; the mass ratio of part of Magnolia officinalis to the remaining Magnolia officinalis is 1:2;

[0080] S2, adding hawthorn, lotus leaf and gardenia to the enzyme solution, adjusting the pH to 6, enzymolyzing at 30°C for 1 hour, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0081] The mass of the enzyme solution is 4 times the total mass of hawthorn, lotus leaf and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3:2:100;

[0082] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.1, and vacuum dry to obtain.

[0083] Comparative Example 3

[0084] Comparative Example 3 is different from Example 1 only in step S1, which is as follows:

[0085] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 20 parts of Magnolia officinalis, 12 parts of Atractylodes macrocephala, 15 parts of Citrus aurantium, 5 parts of Codonopsis pilosula, 8 parts of Angelica sinensis, 2 parts of Cinnamon bark, 10 parts of Tangerine peel, 10 parts of Crataegus pinnatifida, 25 parts of Lotus leaf, 10 parts of Bidens pilosa, and 1 part of Gardenia jasminoides;

[0086] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0087] S1. Add Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and Magnolia officinalis to ethanol, perform a first alcohol extraction at 60° C. for 2 h, and filter to obtain a medicinal solution and a medicinal residue; add ethanol to the medicinal residue, perform a second alcohol extraction at 60° C. for 1 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0088] The mass of ethanol in the first alcohol extraction is 7 times the total mass of Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and Magnolia officinalis; the mass of ethanol in the second alcohol extraction is 4 times the total mass of the residues;

[0089] S2, adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to the enzyme solution, adjusting the pH to 6, performing enzymolysis at 30°C for 1 hour, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0090] The mass of the enzyme solution is 4 times the total mass of hawthorn, lotus leaf, Bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3:2:100;

[0091] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.1, and vacuum dry to obtain.

[0092] Comparative Example 4

[0093] Comparative Example 4 is different from Example 1 only in step S2, which is as follows:

[0094] A Chinese medicine composition for treating spleen and stomach disharmony, comprising the following raw materials in parts by weight: 20 parts of Magnolia officinalis, 12 parts of Atractylodes macrocephala, 15 parts of Citrus aurantium, 5 parts of Codonopsis pilosula, 8 parts of Angelica sinensis, 2 parts of Cinnamon bark, 10 parts of Tangerine peel, 10 parts of Crataegus pinnatifida, 25 parts of Lotus leaf, 10 parts of Bidens pilosa, and 1 part of Gardenia jasminoides;

[0095] A method for preparing a Chinese medicine composition for treating spleen and stomach disharmony comprises the following steps:

[0096] S1. Add Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, perform a first alcohol extraction at 60° C. for 2 h, and filter to obtain a medicinal solution and a medicinal residue; add the remaining Magnolia officinalis and ethanol to the medicinal residue, perform a second alcohol extraction at 60° C. for 1 h, filter, and combine the extracted medicinal solutions to obtain an extract;

[0097] The mass of ethanol in the first alcohol extraction is 7 times the total mass of Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the second alcohol extraction is 4 times the total mass of the residue and the remaining Magnolia officinalis; the mass ratio of part of Magnolia officinalis to the remaining Magnolia officinalis is 1:2;

[0098] S2, adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to the enzyme solution, adjusting the pH to 6, performing enzymolysis at 30°C for 1 hour, boiling, inactivating, filtering, and obtaining an enzymolysis solution;

[0099] The mass of the enzyme solution is 4 times the total mass of hawthorn, lotus leaf, Bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase and water in a mass ratio of 1:3:100;

[0100] S3. Mix the extract and the enzymatic hydrolysate, reduce the pressure, concentrate to a relative density of 1.1, and vacuum dry to obtain.

[0101] Performance Testing

[0102] The comprehensive performance of the Chinese medicine compositions for treating spleen and stomach disharmony prepared in Examples 1-3 of the present application and Comparative Examples 1-4 were tested respectively.

[0103] 1. Animal activity evaluation

[0104] 100 SD healthy rats (SPF grade) were numbered and randomly divided into a blank group and a model group according to a random number table, wherein the blank group had 10 rats (half male and half female). After the modeling was completed, 90 rats with successful modeling were randomly divided into a model group, a Chinese medicine composition group of Examples 1-3 and Comparative Examples 1-4, and a Xiao Chaihu Decoction group according to a random number table method, with 10 rats in each group (half male and half female).

[0105] The model was established by the composite etiology method, using the method of chronic restraint stress + excessive fatigue + dietary disorder, restraint and tail clamping for 30 minutes, and shaking for 5 minutes. All rats were pre-swimmed before the experiment, and rats with swimming time less than 10 minutes and more than 20 minutes were eliminated. The rats with qualified pre-swimming were placed in a restraint box at 8:00 every morning for 3 hours, and the tails were clamped for 30 minutes and shaken for 5 minutes. At 14:00 in the afternoon, they were placed in a large plastic bucket filled with warm water and swam for 10 minutes (water temperature was about 22°C). Sufficient food was given every other day, and fasting was performed every other day for 21 consecutive days. The blank group was fed normally without any treatment; the model group was tied up and restrained for 30 minutes every day after modeling, and 0.9% sodium chloride injection was gavaged, and the gavage volume was 1 mL / 100 g body weight (the same below); the Chinese medicine composition groups of Examples 1-3 and Comparative Examples 1-4 were tied up and restrained for 30 minutes after modeling, and the Chinese medicine composition of Examples 1-3 and Comparative Examples 1-4 was gavaged (10 g Chinese medicine composition / 100 g water, for a total of 14 days); the Xiao Chaihu Decoction group was tied up and restrained for 30 minutes after modeling, and Xiao Chaihu Decoction granules 10 g / 100 g were gavaged for a total of 14 days.

[0106] After the experiment, fast for 24 hours, anesthetize with 20% urethane 4mL / kg intraperitoneally, collect blood from the abdominal aorta, place at room temperature for 2 hours, centrifuge at 4℃, 3000rpm for 15 minutes, take the supernatant, and store at -20℃ for testing; enzyme-linked immunosorbent assay is used to detect the levels of IL-6, IL-1β and TNF-α in rat serum. Statistical software is used for data processing and analysis, and the specific results are shown in Table 1:

[0107] Table 1:

[0108]

[0109] Note: Lowercase letters indicate statistical significance between each drug-treated group and the model group, a: p < 0.001; b: p < 0.01; c: p < 0.05; uppercase letters indicate statistical differences between the model group and the blank control group, A: p < 0.001; B: p < 0.01; C: p < 0.05.

[0110] Compared with the blank group, the serum IL-6, IL-1β and TNF-α of the rats in the model group were all increased, and the difference was statistically significant (P < 0.01), indicating that the modeling was successful. Compared with the model group, the serum IL-6, IL-1β and TNF-α of the rats in Examples 1-3, Comparative Examples 1-4 and Xiao Chaihu Decoction groups were all decreased (P < 0.01) and significantly reduced. Comparing Examples 1-3 with Comparative Examples 1-4, it was found that the content of IL-6, IL-1β and TNF-α in rat serum was significantly reduced, and the reduction in Example 1-3 was greater, which fully demonstrated that the Chinese medicine composition obtained in this application can correct the imbalance of IL-6, IL-1β and TNF-α by down-regulating proinflammatory factors, promote gastrointestinal motility recovery, and has a significant therapeutic effect on the treatment of postprandial discomfort syndrome of functional dyspepsia of spleen and stomach disharmony type. Further comparison of Example 1 with Comparative Examples 1 and 2 revealed that Fructus Aurantii Immaturus and Bidens pilosa have obvious synergistic effects in combination with other medicinal ingredients in the formula of the present application, regulate the body's immunity, reduce inflammatory response, improve gastrointestinal dysfunction, and effectively treat postprandial discomfort symptoms of functional dyspepsia of spleen and stomach disharmony type.

[0111] 2. Clinical effect

[0112] A total of 200 patients with postprandial discomfort syndrome of functional dyspepsia of spleen and stomach disharmony type were selected for observation. The main symptoms were fullness in the stomach and early satiety after meals, and the secondary symptoms were nausea, belching, irritability and sighing; 100 males and 100 females; aged 21-78 years, with an average of 45 years; the course of disease was 2-4 years, with an average of 2.7 years; they were randomly divided into a treatment group of 100 groups and a control group of 100 groups; the Chinese medicine composition obtained in Example 1 of the present application was used as the treatment group; the Xiao Chaihu Decoction group was used as the control group (3 times / d, 9g / time). Both groups were reviewed once a week, and 4 weeks was a course of treatment.

[0113] The efficacy of the two groups was evaluated according to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes": (1) cured, symptoms such as bloating and stomach pain disappeared after treatment, and the TCM syndrome score decreased by >95%; (2) markedly effective, symptoms improved significantly after treatment, and the TCM syndrome score decreased by 70%-95%; (3) effective, symptoms improved after treatment, and the TCM syndrome score decreased by 30%-69%; (4) ineffective, symptoms did not improve or even worsened after treatment. Total effective rate = [(number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases] × 100%; after 4 weeks of treatment, 9 cases were eliminated from the treatment group, and 91 cases were completed; 12 cases were eliminated from the control group, and 88 cases were completed. The specific results are shown in Table 2.

[0114] Table 2:

[0115] Group Number of cases cure Significant effect efficient invalid Total effective Treatment Group 91 40(44.0％) 35(38.5％) 14(15.4％) 2(2.10％) 89(97.9％) Control group 88 18(20.5％) 24(27.3％) 36(40.9％) 10(11.4％) <![CDATA[78(88.6%) * ]]>

[0116] Note: Compared with the control group: * p<0.05.

[0117] It can be seen from the above table that the Chinese medicine composition of the present application has a good therapeutic effect on the treatment of functional dyspepsia and postprandial discomfort syndrome of spleen and stomach disharmony type, improves the clinical symptoms of patients, has fewer adverse drug reactions, has a higher safety of the drug, and has a good clinical repeated use value.

[0118] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A Chinese medicine composition for treating spleen and stomach disharmony, characterized in that: The invention comprises the following raw materials in parts by weight: 20-30 parts of Magnolia officinalis, 12-18 parts of Atractylodes macrocephala, 15-25 parts of Citrus aurantium, 5-15 parts of Codonopsis pilosula, 8-20 parts of Angelica sinensis, 2-10 parts of cinnamon bark, 10-18 parts of dried tangerine peel, 10-18 parts of hawthorn, 25-35 parts of lotus leaf, 10-15 parts of Bidens pilosa, and 1-5 parts of Gardenia jasminoides.

2. The Chinese medicine composition for treating spleen and stomach disharmony according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 25 parts of Magnolia officinalis, 15 parts of Atractylodes macrocephala, 20 parts of Citrus aurantium, 10 parts of Codonopsis pilosula, 10 parts of Angelica sinensis, 8 parts of Cinnamon bark, 15 parts of Tangerine peel, 15 parts of Crataegus pinnatifida, 30 parts of Lotus leaf, 12 parts of Bidens pilosa, and 2 parts of Gardenia jasminoides.

3. A method for preparing the Chinese medicine composition for treating spleen and stomach disharmony according to claim 1 or claim 2, characterized in that: The following steps are involved: S1, extracting Magnolia officinalis, Atractylodes macrocephala, Citrus aurantium immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, and Tangerine peel with alcohol to obtain an extract; S2, enzymatically hydrolyzing the hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides to obtain an enzymatic hydrolyzate; S3, mixing the extract and the enzymatic hydrolysate, concentrating and drying.

4. The method for preparing the Chinese medicine composition for treating spleen and stomach disharmony according to claim 3, characterized in that: The alcohol extraction in S1 includes adding Atractylodes macrocephala, Fructus Aurantii Immaturus, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis to ethanol, performing a first alcohol extraction at 60-70° C. for 2-4 hours, filtering to obtain a medicinal solution and a medicinal residue; adding the remaining Magnolia officinalis and ethanol to the medicinal residue, performing a second alcohol extraction at 60-70° C. for 1-3 hours, filtering, and combining the extracted medicinal solutions to obtain an extract.

5. The method for preparing the Chinese medicine composition for treating spleen and stomach disharmony according to claim 4, characterized in that: The mass of ethanol in the first alcohol extraction is 7-10 times the total mass of Atractylodes macrocephala, Citrus aurantium, Codonopsis pilosula, Angelica sinensis, Cinnamon bark, Tangerine peel and part of Magnolia officinalis; the mass of ethanol in the second alcohol extraction is 4-6 times the total mass of the residues and the remaining Magnolia officinalis.

6. The method for preparing the Chinese medicine composition for treating spleen and stomach disharmony according to claim 5, characterized in that: The mass ratio of the part of Magnolia officinalis to the remaining Magnolia officinalis is 1:2-4.

7. The method for preparing the Chinese medicine composition for treating spleen and stomach disharmony according to claim 3, characterized in that: The enzymatic hydrolysis in S2 includes adding hawthorn, lotus leaf, Bidens pilosa and Gardenia jasminoides into an enzyme solution, adjusting the pH to 6-7, enzymatic hydrolysis at 30-45° C. for 1-2 hours, boiling, inactivating, filtering, and obtaining an enzymatic hydrolyzate.

8. The method for preparing the Chinese medicine composition for treating spleen and stomach disharmony according to claim 7, characterized in that: The mass of the enzyme solution is 4-6 times the total mass of hawthorn, lotus leaf, bidens pilosa and gardenia; the enzyme solution is obtained by mixing xylanase, cellulase, pectinase and water in a mass ratio of 1:3-7:1-8:

100.

9. Use of the Chinese medicine composition for treating spleen and stomach disharmony according to claim 1 or claim 2 in preparing a medicine for treating spleen and stomach disharmony.

10. The use according to claim 9, characterized in that The dosage form of the medicine includes one of pills, powders, powders, tablets, pastes, capsules, granules, oral liquids, and Chinese medicine decoctions.

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