Composition for tonifying spleen and reducing weight, preparation method and application

Abstract

The invention provides a spleen-tonifying and weight-losing composition, a preparation method and application, and belongs to the technical field of traditional Chinese medicines. In the application, codonopsis pilosula and bighead atractylodes rhizome are taken as monarch drugs, poria cocos, rhizoma pinelliae preparata and pericarpium citri reticulatae are taken as ministerial drugs, astragalus membranaceus, fried coix seeds, hyacinth beans, radix stephaniae tetrandrae, immature bitter oranges, fingered citron, bamboo shavings, lotus leaves, mulberry leaves and haws are taken as adjuvant drugs, and liquorice is taken as a conductant drug, so that the traditional Chinese medicine composition has the effects of invigorating spleen, replenishing qi, eliminating dampness, reducing phlegm, regulating qi and eliminating dampness together, and can be used for removing stagnated phlegm dampness in a body, tonifying deficiency of spleen and stomach and reactivating functions; the traditional Chinese medicine composition can be used for fundamentally improving the simple obesity state of children, is mild in medicine property, is suitable for long-term conditioning of children, and is suitable for children and adolescents with spleen deficiency and excessive dampness, qi stagnation and spleen deficiency and phlegm-dampness syndromes, so that the aim of treating simple obesity, insulin resistance, hyperlipidemia, fatty liver, hyperuricemia and other symptoms of children is achieved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a spleen-strengthening and body-lightening composition, its preparation method, and its application. Background Technology

[0002] With changes in biochemistry and an unhealthy diet, more and more children are facing obesity. Obesity not only affects the normal growth of children's bones, muscles, and other systems, but also leads to problems such as insulin resistance, metabolic syndrome, hypertension, type 2 diabetes, polycystic ovary syndrome, and obstructive sleep apnea syndrome, thus impacting children's development.

[0003] Simple obesity in children, often classified as spleen deficiency with phlegm-dampness syndrome, is frequently caused by impaired spleen and stomach function, leading to the accumulation of phlegm and dampness in the body, resulting in an imbalance in energy metabolism and fat accumulation. Symptoms of simple obesity in children include obesity, abdominal distension, heaviness in the limbs, loose or constipated stools, sallow complexion, fatigue, shortness of breath and sweating upon exertion, sticky or sweet taste in the mouth, chest tightness, pale or swollen tongue with a thick or greasy white coating, and a slippery pulse. Because children's endocrine system is unstable, most weight-loss drugs are not suitable for them. The principle of intervention and treatment for simple obesity in children should first and foremost ensure that it does not hinder normal growth and development. Under these circumstances, traditional Chinese medicine can leverage its advantages of personalized treatment, definite efficacy, few adverse reactions, multiple pathways, multiple targets, and diverse dosage forms, showing promising potential in the treatment of childhood obesity. Summary of the Invention

[0004] The purpose of this invention is to provide a spleen-strengthening and weight-loss composition and its application to solve the problem of poor treatment effects in children with simple obesity.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: In one aspect, this application provides a spleen-strengthening and body-slimming composition, wherein the raw materials for preparing the spleen-strengthening and body-slimming composition include, by weight: 20-30g of Codonopsis pilosula, 20-30g of Atractylodes macrocephala, 20-30g of Poria cocos, 8-12g of Pinellia ternata, 10-15g of Citrus reticulata peel, 5-8g of Glycyrrhiza uralensis, 20-30g of Astragalus membranaceus, 20-30g of Coix lacryma-jobi (fried), 12-18g of Dolichos lablab, 10-15g of Stephania tetrandra, 10-15g of Citrus aurantium, 10-15g of Citrus medica, 8-12g of Bambusa textilis, 10-15g of Nelumbo nucifera leaf, 10-15g of Morus alba leaf, and 10-15g of Crataegus pinnatifida.

[0006] Secondly, this application provides a method for preparing a spleen-strengthening and weight-loss composition. When the spleen-strengthening and weight-loss composition is in the form of granules, the method includes: Add Atractylodes macrocephala and Citrus reticulata peel to 6-10 times the amount of water, steam distill for 2-5 hours, condense and filter to obtain volatile oil, aqueous solution and dregs; The volatile oil and β-cyclodextrin were stirred and encapsulated, and then dried at 60°C to obtain the volatile oil inclusion complex; The dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, Coix lacryma-jobi (stir-fried), Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida were added to water and decocted twice. The decoctions were combined, filtered, and concentrated at 60°C to obtain a clear extract with a relative density of 1.2-1.25. Add 3 times the amount of ethanol to the ointment, stir well, let stand for 12-18 hours, filter, and obtain the filtrate. The filtrate and the aqueous solution were combined, concentrated at 60°C to a relative density of 1.3-1.35, dried under reduced pressure, and pulverized to obtain a fine powder. The volatile oil inclusion complex, the fine powder, the soluble starch and steviol glycosides are mixed, and purified water is added in small amounts several times. The mixture is then granulated and dried to obtain spleen-strengthening and body-lightening granules.

[0007] Thirdly, this application provides another method for preparing a spleen-strengthening and weight-loss composition. When the spleen-strengthening and weight-loss composition is a tablet or capsule, the method includes: Add Atractylodes macrocephala and Citrus reticulata peel to 6-10 times the amount of water, steam distill for 2-5 hours, condense and filter to obtain volatile oil, aqueous solution and dregs; The volatile oil and β-cyclodextrin were stirred and encapsulated, and then dried at 60°C to obtain the volatile oil inclusion complex; The dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, Coix lacryma-jobi (stir-fried), Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida were added to water and decocted twice. The decoctions were combined, filtered, and concentrated at 60°C to obtain a clear extract with a relative density of 1.2-1.25. Add 3 times the amount of ethanol to the ointment, stir well, let stand for 12-18 hours, filter, and obtain the filtrate. The filtrate and the aqueous solution were combined, concentrated at 60°C to a relative density of 1.3-1.35, dried under reduced pressure, and pulverized to obtain a fine powder. The fine powder and microcrystalline cellulose are mixed into granules, dried, and then the volatile oil inclusion complex is added and mixed evenly. The mixture is then compressed into tablets and coated with a film to obtain spleen-strengthening and weight-loss tablets; or it is encapsulated to obtain spleen-strengthening and weight-loss capsules.

[0008] Fourthly, this application provides another method for preparing a spleen-strengthening and weight-loss composition. When the spleen-strengthening and weight-loss composition is a concentrated pill, the method includes: Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Citrus reticulata peel are ground into a fine powder; Pinellia ternata, licorice, astragalus membranaceus, stir-fried coix seed, hyacinth bean, Stephania tetrandra, immature bitter orange, citron, bamboo shavings, lotus leaf, mulberry leaf and hawthorn are added to water and decocted twice. The decoctions are combined, filtered, and concentrated at 60°C to obtain a thick paste with a relative density of 1.3-1.35. The thick paste is dried under reduced pressure, pulverized, and then mixed with the fine powder. Water is used as a wetting agent to make pills, which are then dried to obtain a concentrated pill for strengthening the spleen and lightening the body.

[0009] Fifthly, this application provides an application of a spleen-strengthening and weight-loss composition, namely, for the preparation of a drug for treating simple obesity in children.

[0010] The present invention has the following beneficial effects: In this application, Codonopsis pilosula and Atractylodes macrocephala are used as the principal herbs, Poria cocos, Pinellia ternata, and Citrus reticulata are used as the assistant herbs, Astragalus membranaceus, Coix lacryma-jobi (fried), Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida are used as the adjuvant herbs, and Glycyrrhiza uralensis is used as the guiding herb. Together, they work to invigorate the spleen and replenish qi, dry dampness and resolve phlegm, regulate qi and dispel dampness. They can not only remove phlegm and dampness that has accumulated in the body, but also replenish the spleen and stomach and restore their digestive function, fundamentally improving the condition of simple obesity in children. Moreover, the medicinal properties are mild and suitable for long-term conditioning in children. They are suitable for children and adolescents with spleen deficiency and dampness, qi stagnation, and spleen deficiency with phlegm and dampness syndrome, so as to achieve the purpose of treating simple obesity, insulin resistance, hyperlipidemia, fatty liver, hyperuricemia and other diseases in children. Attached Figure Description

[0011] Figure 1 Venny diagram showing the common target of the spleen-strengthening and weight-loss composition provided in Example 1 of this application and simple obesity in children; Figure 2 This is a network diagram of the spleen-strengthening and weight-reducing composition provided in Example 1 of this application and the traditional Chinese medicine-component-intersection target network for simple obesity in children; Figure 3 The diagram shows the KEGG (Kyoto Encyclopedia of Genes and Genomes) analysis of the spleen-strengthening and weight-loss composition provided in Example 1 of this application and simple obesity in children. Detailed Implementation

[0012] This application provides a spleen-strengthening and body-slimming composition, the raw materials for which are prepared by weight include: Codonopsis pilosula 20-30g, Atractylodes macrocephala 20-30g, Poria cocos 20-30g, Pinellia ternata 8-12g, Citrus reticulata peel 10-15g, Glycyrrhiza uralensis 5-8g, Astragalus membranaceus 20-30g, Coix lacryma-jobi (fried) 20-30g, Dolichos lablab 12-18g, Stephania tetrandra 10-15g, Citrus aurantium 10-15g, Citrus medica 10-15g, Bambusa textilis 8-12g, Nelumbo nucifera leaf 10-15g, Morus alba leaf 10-15g, and Crataegus pinnatifida 10-15g.

[0013] The specific pharmacological effects are as follows: Codonopsis pilosula: It tastes sweet and is neutral in nature, entering the spleen and lung meridians, with the effects of invigorating the spleen and stomach, moistening the lungs and promoting the production of body fluids, strengthening the middle qi, and having a gentle qi-tonifying effect. Atractylodes macrocephala: It tastes sweet and bitter and is warm in nature, entering the spleen and stomach meridians, with the effects of invigorating the spleen with sweet and warming herbs and drying dampness with bitter and warming herbs. Codonopsis pilosula and Atractylodes macrocephala, as the monarch herbs together, can make Codonopsis pilosula tonify without stagnation, enhance the function of strengthening the spleen and replenishing qi, and enhance the transportation and transformation function of the spleen and stomach. The two work together to achieve the effects of "tonifying the spleen qi and strengthening transportation and transformation", fundamentally reducing the generation of phlegm-dampness and solving the problem of spleen deficiency and failure of transportation.

[0014] Poria cocos: It tastes sweet and light and is neutral in nature, entering the heart, spleen and kidney meridians, with the effects of promoting diuresis and percolating dampness with sweet and light herbs, being neutral and not biased, promoting diuresis and percolating dampness, and strengthening the spleen and replenishing qi. It can not only assist Atractylodes macrocephala to enhance the power of strengthening the spleen and dispelling dampness, but also prevent the endogenous generation of dampness pathogens, and is the key for "strengthening the spleen and dispelling dampness". Pinellia ternata (processed): Also known as Diewen and Shuiyu, it tastes pungent and is warm in nature, entering the spleen and stomach meridians, with the effects of drying dampness and resolving phlegm, descending adverse qi and harmonizing the stomach, and dissipating masses and resolving stagnation; Citrus reticulata Blanco: It tastes pungent and bitter and is warm in nature, entering the spleen and lung meridians, with the effects of regulating qi and strengthening the spleen, and drying dampness and resolving phlegm. The use of Pinellia ternata (processed) and Citrus reticulata Blanco can resolve the "phlegm-dampness" generated by spleen deficiency, and can also regulate qi to prevent the stagnation of qi-tonifying herbs. They are the minister herbs together with Poria cocos.

[0015] Astragalus membranaceus: It tastes sweet and is slightly warm in nature, entering the lung and spleen meridians, with the effects of invigorating qi and consolidating the exterior, strengthening the healthy qi and dispelling pathogenic factors, and strengthening the spleen and replenishing qi. When Astragalus membranaceus is combined with Codonopsis pilosula, it can enhance the qi-supplementing effect of Codonopsis pilosula on the spleen and stomach, and is suitable for those with long-term spleen deficiency and obvious fatigue.

[0016] Coix lacryma-jobi L. var. ma-yuen (parched): It tastes sweet and light and is cool in nature, entering the spleen, stomach and lung meridians, with the effects of strengthening the spleen and benefiting the stomach, clearing heat in the lungs, and expelling wind and eliminating dampness. Dolichos lablab: It tastes sweet and is slightly warm, entering the spleen and stomach meridians, with the effects of strengthening the spleen and regulating the middle, and dispelling summer heat and resolving dampness. Stephania tetrandra S. Moore: It tastes bitter and is cold in nature, entering the bladder and lung meridians, with the effects of expelling wind and relieving pain, and promoting diuresis and reducing swelling. The synergistic use of Coix lacryma-jobi L. var. ma-yuen (parched), Dolichos lablab and Stephania tetrandra S. Moore can not only enhance the power of dispelling dampness, but also tonify the deficiency of the spleen and stomach, and is suitable for those with "excessive dampness" such as heaviness and discomfort in the limbs and loose stools.

[0017] Fructus Aurantii Immaturus: It tastes pungent and bitter and is slightly cold in nature, entering the spleen, stomach and large intestine meridians, with the effects of breaking qi and reducing accumulation, and resolving phlegm and relieving fullness. Citrus medica L. var. sarcodactylis Swingle: It tastes pungent, bitter and sour and is warm in nature, entering the liver, spleen, stomach and lung meridians, with the effects of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm. After the combination of Fructus Aurantii Immaturus and Citrus medica L. var. sarcodactylis Swingle, it can dredge the qi mechanism, relieve distension and fullness, and is suitable for those with "qi stagnation" such as abdominal distension and fullness.

[0018] Caulis Bambusae in Taeniis: It tastes sweet and is slightly cold in nature, entering the lungs, stomach, heart and gallbladder meridians, with the effects of clearing heat and resolving phlegm, relieving restlessness, and stopping vomiting. Folium Nelumbinis: It tastes bitter and astringent and is neutral in nature, entering the liver, spleen and stomach meridians, with the effects of clearing summer heat and relieving thirst, awakening the spleen and promoting appetite, and resolving dampness and reducing lipid. Folium Mori: It tastes sweet and bitter and is cold in nature, entering the lungs and liver meridians, with the effects of being mild, ascending and dispersing, and dispersing the lung qi. After the combination of Caulis Bambusae in Taeniis, Folium Nelumbinis and Folium Mori, it can clear and transform heat-dampness, prevent dryness from injuring body fluids, is applicable to the mild heat symptoms that may occur when phlegm-dampness lasts for a long time, and also balances the warm and dry nature of Pinellia ternata (processed) and Citrus reticulata Blanco.

[0019] Hawthorn: Sour and sweet, slightly warm, it enters the spleen, stomach and liver meridians. It has the effects of promoting digestion and strengthening the stomach, promoting qi circulation and removing blood stasis, and clearing turbidity and lowering lipids. It can solve problems such as spleen deficiency, abdominal distension after meals, and belching.

[0020] The above-mentioned herbs, including Astragalus membranaceus, stir-fried Coix lacryma-jobi, Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida, can enhance the spleen-strengthening, dampness-removing, qi-tonifying, and stagnation-relieving effects. They can also harmonize the cold and hot properties of the herbs in the formula, making the overall formula more balanced and in line with the physiological characteristics of children's delicate organs and insufficient qi and blood. Therefore, they are used as adjuvant herbs.

[0021] Licorice: It has a sweet taste and neutral properties. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, and relieving pain. It can harmonize the warming and tonifying properties of Codonopsis and Atractylodes macrocephala with the drying properties of Pinellia ternata and Citrus reticulata, making the whole formula mild. It is the guiding herb that harmonizes the properties of all the herbs.

[0022] This spleen-strengthening and weight-loss composition uses Codonopsis pilosula and Atractylodes macrocephala as the principal herbs, Poria cocos, Pinellia ternata, and Citrus reticulata as the assistant herbs, Astragalus membranaceus, Coix lacryma-jobi (fried), Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida as adjuvant herbs, and Glycyrrhiza uralensis as the guiding herb. Together, they work to strengthen the spleen and replenish qi, dry dampness and resolve phlegm, regulate qi and dispel dampness. It can not only remove phlegm and dampness that has accumulated in the body, but also replenish the spleen and stomach and restore their digestive function, fundamentally improving the condition of simple obesity in children. Moreover, the medicinal properties are mild and suitable for long-term conditioning in children. It is suitable for children and adolescents with spleen deficiency and dampness, qi stagnation, and spleen deficiency with phlegm and dampness syndrome, so as to achieve the purpose of treating simple obesity, insulin resistance, hyperlipidemia, fatty liver, hyperuricemia and other diseases in children. In this application embodiment, spleen deficiency manifests as fatigue, shortness of breath, lethargy, loss of appetite, loose stools, pale tongue, and weak pulse; dampness manifests as obesity, heaviness in the limbs, abdominal distension, belching, and white, greasy tongue coating.

[0023] Preferred ingredients for this spleen-strengthening and body-lightening composition include, by weight: Codonopsis pilosula 24-26g, Atractylodes macrocephala 24-26g, Poria cocos 24-26g, Pinellia ternata 9-10g, Citrus reticulata 11-13g, Glycyrrhiza uralensis 5-6g, Astragalus membranaceus 24-26g, Coix lacryma-jobi 24-26g, Dolichos lablab 14-16g, Stephania tetrandra 11-13g, Citrus aurantium 11-13g, Citrus medica 11-13g, Bambusa textilis 8-9g, Nelumbo nucifera leaf 11-13g, Morus alba leaf 11-13g, and Crataegus pinnatifida 11-13g.

[0024] More preferably, the raw materials for preparing this spleen-strengthening and body-lightening composition include, by weight: 24g of Codonopsis pilosula, 24g of Atractylodes macrocephala, 24g of Poria cocos, 9g of Pinellia ternata, 12g of Citrus reticulata peel, 6g of Glycyrrhiza uralensis, 24g of Astragalus membranaceus, 24g of Coix lacryma-jobi (fried), 15g of Dolichos lablab, 12g of Stephania tetrandra, 12g of Citrus aurantium, 12g of Citrus medica, 9g of Bambusa textilis, 12g of Nelumbo nucifera leaf, 12g of Morus alba leaf, and 12g of Crataegus pinnatifida.

[0025] The dosage form of the spleen-strengthening and body-lightening composition in the embodiments of this application is granules, tablets, capsules or concentrated pills.

[0026] When the spleen-strengthening and body-lightening composition is in the form of granules, its preparation method includes: S01: Add Atractylodes macrocephala and Citrus reticulata peel to 6-10 times the amount of water, and distill using steam distillation for 2-5 hours. After condensation and filtration, volatile oil, aqueous solution and dregs are obtained. S02: Mix the volatile oil and β-cyclodextrin at a volume-to-mass ratio of 1:1-1.5, stir to encapsulate, and dry at 60℃ for 6-12 hours to obtain the volatile oil inclusion complex.

[0027] S03: Add the dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, stir-fried Coix lacryma-jobi, Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera leaf, Morus alba leaf, and Crataegus pinnatifida to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After both decoctions, combine the decoctions, filter, and heat at 60℃ to concentrate to obtain a clear extract with a relative density of 1.2-1.25.

[0028] S04: Add 3 times the amount of ethanol to the extract, stir well, and let stand for 12-18 hours to allow the active ingredients in the extract to be extracted into the ethanol. After standing, filter to obtain the filtrate.

[0029] S05: After combining the filtrate and aqueous solution, heat and concentrate at 60℃ to a relative density of 1.3-1.35; after drying under reduced pressure at 40-55 kPa and 50-60℃, pulverize to a particle size of 100-300 mesh to obtain fine powder.

[0030] S06: The volatile oil inclusion complex, fine powder, soluble starch, and steviol glycosides are mixed evenly in a mass ratio of 1:(1-2):(2-4):(2-4). Purified water is added in small amounts several times, and the mixture is granulated and dried to obtain spleen-strengthening and body-lightening granules. The soluble starch is selected from soluble starch made from rice, corn, millet, sweet potato, or potato.

[0031] When the spleen-strengthening and body-lightening composition is in the form of tablets or capsules, its preparation method includes: S01: Add Atractylodes macrocephala and Citrus reticulata peel to 6-10 times the amount of water, and distill using steam distillation for 2-5 hours. After condensation and filtration, volatile oil, aqueous solution and dregs are obtained. S02: Mix the volatile oil and β-cyclodextrin at a volume-to-mass ratio of 1:1-1.5, stir to encapsulate, and dry at 60℃ for 6-12 hours to obtain the volatile oil inclusion complex.

[0032] S03: Add the dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, stir-fried Coix lacryma-jobi, Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera leaf, Morus alba leaf, and Crataegus pinnatifida to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After both decoctions, combine the decoctions, filter, and concentrate at 60℃ to obtain a clear extract with a relative density of 1.2-1.25.

[0033] S04: Add 3 times the amount of ethanol to the extract, stir well, and let stand for 12-18 hours to allow the active ingredients in the extract to be extracted into the ethanol. After standing, filter to obtain the filtrate.

[0034] S05: After combining the filtrate and aqueous solution, heat and concentrate at 60℃ to a relative density of 1.3-1.35; after drying under reduced pressure at 40-55 kPa and 50-60℃, pulverize to a particle size of 100-300 mesh to obtain fine powder.

[0035] S06: After mixing fine powder and microcrystalline cellulose at a mass ratio of 1:(1-1.5), add purified water in small amounts several times, granulate and dry; then add volatile oil inclusion complex and mix well; after tableting and film coating, obtain spleen-strengthening and weight-loss tablets; or directly fill into capsules to obtain spleen-strengthening and weight-loss capsules.

[0036] When the spleen-strengthening and body-lightening composition is a concentrated pill, its preparation method includes: S01: Grind Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Citrus reticulata into fine powder with a particle size of 100-300 mesh; S02: Add Pinellia ternata, licorice root, Astragalus membranaceus, stir-fried Coix seed, hyacinth bean, Stephania tetrandra, Citrus aurantium, Citrus medica, bamboo shavings, lotus leaf, mulberry leaf, and hawthorn to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After the two decoctions are completed, combine the decoctions, filter, and heat at 60℃ to concentrate to obtain a thick paste with a relative density of 1.3-1.35.

[0037] S03: The thick paste is dried under reduced pressure at 40-55 kPa and 50-60℃, pulverized to a particle size of 100-300 mesh, and then mixed with fine powder at a mass ratio of 1:(1-2). Water is used as a wetting agent to make pills, and after drying, the spleen-strengthening and body-lightening concentrated pills are obtained.

[0038] The technical solution of the present invention will be further explained and described below through specific embodiments.

[0039] Example 1 This application provides a spleen-strengthening and body-lightening granule. The raw materials for preparing the spleen-strengthening and body-lightening granule include, by weight: 24g of Codonopsis pilosula, 24g of Atractylodes macrocephala, 24g of Poria cocos, 9g of Pinellia ternata, 12g of Citrus reticulata peel, 6g of Glycyrrhiza uralensis, 24g of Astragalus membranaceus, 24g of Coix lacryma-jobi (fried), 15g of Dolichos lablab, 12g of Stephania tetrandra, 12g of Citrus aurantium, 12g of Citrus medica, 9g of Bambusa textilis, 12g of Nelumbo nucifera leaf, 12g of Morus alba leaf, and 12g of Crataegus pinnat

[0040] This application provides a method for preparing spleen-strengthening and body-lightening granules, the method comprising: S101: Add Atractylodes macrocephala and Citrus reticulata peel to 8 times the amount of water, and distill using steam distillation for 4 hours. After condensation and filtration, volatile oil, aqueous solution and dregs are obtained. S102: The volatile oil and β-cyclodextrin were mixed at a volume-to-mass ratio of 1:1, stirred and incorporated, and dried at 60°C for 10 hours to obtain the volatile oil inclusion complex.

[0041] S103: Add the dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, stir-fried Coix lacryma-jobi, Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera leaf, Morus alba leaf, and Crataegus pinnatifida to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After both decoctions, combine the decoctions, filter, and heat at 60°C to concentrate to obtain a clear extract with a relative density of 1.2.

[0042] S104: Add 3 times the amount of ethanol to the extract, stir well, and let stand for 15 hours to allow the active ingredients in the extract to be extracted into the ethanol. After standing, filter to obtain the filtrate.

[0043] S105: After combining the filtrate and aqueous solution, heat and concentrate at 60°C to a relative density of 1.3; after drying under reduced pressure at 45 kPa and 55°C, pulverize to a particle size of 150 mesh to obtain fine powder.

[0044] S106: The volatile oil inclusion complex, fine powder, soluble starch and steviol glycosides are mixed evenly in a mass ratio of 1:2:3:3. Purified water is added in small amounts several times, and the mixture is granulated and dried to obtain spleen-strengthening and body-lightening granules.

[0045] Example 2 This application provides a spleen-strengthening and weight-loss tablet, the raw materials for which are prepared by weight include: Codonopsis pilosula 20g, Atractylodes macrocephala 26g, Poria cocos 24g, Pinellia ternata 9g, Citrus reticulata peel 11g, Glycyrrhiza uralensis 8g, Astragalus membranaceus 26g, Coix lacryma-jobi 30g, Dolichos lablab 16g, Stephania tetrandra 13g, Citrus aurantium 13g, Citrus medica 13g, Bambusa textilis 12g, Nelumbo nucifera leaf 13g, Morus alba leaf 13g, and Crataegus pinnatifida 13g.

[0046] This application provides a method for preparing a spleen-strengthening and weight-loss tablet, the method comprising: S201: Add Atractylodes macrocephala and Citrus reticulata peel to 6 times the amount of water, and distill using steam distillation for 2 hours. After condensation and filtration, volatile oil, aqueous solution and dregs are obtained. S202: The volatile oil and β-cyclodextrin were mixed at a volume-to-mass ratio of 1:1.5, stirred and incorporated, and dried at 60°C for 12 hours to obtain the volatile oil inclusion complex.

[0047] S203: Add the dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, stir-fried Coix lacryma-jobi, Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera leaf, Morus alba leaf, and Crataegus pinnatifida to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After both decoctions, combine the decoctions, filter, and concentrate at 60°C to obtain a clear extract with a relative density of 1.25.

[0048] S204: Add 3 times the amount of ethanol to the extract, stir well, and let stand for 18 hours to allow the active ingredients in the extract to be extracted into the ethanol. After standing, filter to obtain the filtrate.

[0049] S205: After combining the filtrate and aqueous solution, heat and concentrate at 60°C to a relative density of 1.35; after drying under reduced pressure at 55 kPa and 50°C, pulverize to a particle size of 100 mesh to obtain fine powder.

[0050] S206: Fine powder and microcrystalline cellulose are mixed evenly at a mass ratio of 1:1.3, purified water is added in small amounts several times, granulation and drying are performed; then, volatile oil inclusion complex is added and mixed evenly; after tableting and film coating, spleen-strengthening and weight-loss tablets are obtained.

[0051] Example 3 This application provides a spleen-strengthening and body-lightening capsule. The raw materials for preparing the spleen-strengthening and body-lightening capsule include, by weight: 26g of Codonopsis pilosula, 30g of Atractylodes macrocephala, 26g of Poria cocos, 10g of Pinellia ternata, 15g of Citrus reticulata peel, 6g of Glycyrrhiza uralensis, 30g of Astragalus membranaceus, 26g of Coix lacryma-jobi (fried), 12g of Dolichos lablab, 11g of Stephania tetrandra, 15g of Citrus aurantium, 15g of Citrus medica, 9g of Bambusa textilis, 11g of Nelumbo nucifera leaf, 11g of Morus alba leaf, and 11g of Crataegus pinnatifida.

[0052] This application provides a method for preparing a spleen-strengthening and body-lightening capsule, the method comprising: S301: Add Atractylodes macrocephala and Citrus reticulata peel to 10 times the amount of water, and distill using steam distillation for 5 hours. After condensation and filtration, volatile oil, aqueous solution and dregs are obtained. S302: The volatile oil and β-cyclodextrin were mixed at a volume-to-mass ratio of 1:1.4, stirred and incorporated, and dried at 60°C for 10 hours to obtain the volatile oil inclusion complex.

[0053] S303: Add the dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, stir-fried Coix lacryma-jobi, Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera leaf, Morus alba leaf, and Crataegus pinnatifida to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After both decoctions, combine the decoctions, filter, and concentrate at 60℃ to obtain a clear extract with a relative density of 1.23.

[0054] S304: Add 3 times the amount of ethanol to the extract, stir well, and let stand for 15 hours to allow the active ingredients in the extract to be extracted into the ethanol. After standing, filter to obtain the filtrate.

[0055] S305: After combining the filtrate and aqueous solution, heat and concentrate at 60°C to a relative density of 1.3; after drying under reduced pressure at 45 kPa and 50°C, pulverize to a particle size of 200 mesh to obtain fine powder.

[0056] S306: After mixing fine powder and microcrystalline cellulose evenly at a mass ratio of 1:1.2, purified water is added in small amounts several times, granulated and dried; then, volatile oil inclusion complex is added and mixed evenly; directly filled into capsules to obtain spleen-strengthening and body-lightening capsules.

[0057] Example 4 This application provides a concentrated spleen-strengthening and body-lightening pill, the raw materials for which are prepared by weight include: 30g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 24g of Poria cocos, 12g of Pinellia ternata, 13g of Citrus reticulata peel, 5g of Glycyrrhiza uralensis, 20g of Astragalus membranaceus, 20g of Coix lacryma-jobi (fried), 14g of Dolichos lablab, 15g of Stephania tetrandra, 11g of Citrus aurantium, 10g of Citrus medica, 8g of Bambusa textilis, 15g of Nelumbo nucifera leaf, 10g of Morus alba leaf, and 10g of Crataegus pinnatifida.

[0058] This application provides a method for preparing a concentrated spleen-strengthening and body-lightening pill, the method comprising: S401: Grind Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Citrus reticulata into a fine powder with a particle size of 200 mesh; S402: Add Pinellia ternata, licorice root, Astragalus membranaceus, stir-fried Coix seed, hyacinth bean, Stephania tetrandra, Citrus aurantium, Citrus medica, bamboo shavings, lotus leaf, mulberry leaf, and hawthorn to water and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour. After the two decoctions are completed, combine the decoctions, filter, and heat at 60℃ to concentrate to obtain a thick paste with a relative density of 1.35.

[0059] S403: The thick paste is dried under reduced pressure at 55 kPa and 50°C, pulverized to a particle size of 200 mesh, and then mixed with fine powder at a mass ratio of 1:1.6. Water is used as a wetting agent to make pills, and after drying, the spleen-strengthening and body-lightening concentrated pills are obtained.

[0060] In this application embodiment, the Jianpi Qingshen Granules prepared in Example 1 are used as an example for clinical trials. The specific content is as follows: The diagnostic criteria for simple obesity in children include both Western medicine diagnostic criteria and traditional Chinese medicine diagnostic criteria.

[0061] The Western medicine diagnostic criteria refer to the "Classification Standard of Body Mass Index Values ​​for Screening Overweight and Obesity in Chinese School-Age Children and Adolescents", "Pediatrics", and the "Expert Consensus on Diagnosis, Assessment and Management of Childhood Obesity in China" for simple obesity: a BMI of 85-95% of the reference value for the same sex and age group is considered overweight, and a BMI of more than 95% is considered obese.

[0062] The TCM diagnostic criteria are based on the "Internal Medicine of Traditional Chinese Medicine" and the "Expert Consensus on the Diagnosis, Assessment and Management of Childhood Obesity in China". The primary symptoms are: obesity, fatigue, abdominal distension, and heaviness in the limbs. Secondary symptoms include: shortness of breath and sweating upon exertion, sticky or sweet taste in the mouth, chest tightness, dizziness, nausea and vomiting, and loose or irregular bowel movements. Tongue and pulse examination: The tongue is pale red or pale and swollen, with a white, slippery or greasy coating; the pulse is soft or slippery and weak upon deep palpation. Differential diagnosis criteria: Each symptom is recorded as either present or absent. If two primary symptoms and one secondary symptom, or one primary symptom and two or more secondary symptoms are present, a diagnosis of simple childhood obesity due to spleen deficiency and phlegm dampness can be made based on the tongue and pulse examination.

[0063] Inclusion criteria: ① Meeting the above diagnostic criteria; ② Age 6–18 years; ③ Exceeding the standard body weight by 20%; ④ Not having received any related interventions within the past month.

[0064] Exclusion criteria: ① Obesity caused by medication; ② History of allergy to any drug component in the treatment; ③ Poor adherence to treatment and inability to complete the full course of treatment; ④ Comorbidities that can cause secondary obesity, such as inherited metabolic disorders, endocrine disorders, hypothyroidism, Cushing's syndrome, etc., as well as malformations that may indicate a genetic syndrome.

[0065] Dropout criteria: ① Allergic reactions or adverse events during the course of the disease; ② Those who voluntarily withdrew for any reason; ③ Those who were lost to follow-up due to inability to be followed up.

[0066] Based on the above diagnostic criteria, inclusion criteria, exclusion criteria, and dropout criteria, 84 children aged 6-18 years who had been diagnosed with simple obesity and had not received relevant intervention within one month were selected. Their mean age was 11.46 ± 1.46 years, mean weight was 67.00 ± 17.48 kg, and mean body mass index (BMI) was 27.14 ± 4.36 kg / m². 2 .

[0067] Based on a health intervention combining diet and exercise, the child was given 10g of the spleen-strengthening and body-lightening granules prepared in Example 1 orally once in the morning and once in the evening for one month. Changes in scores for symptoms such as chest tightness, abdominal distension, heaviness in the limbs, sticky feeling in the mouth, white or greasy tongue coating, and soft or slippery pulse were recorded before and after treatment. Asymptomatic symptoms were scored as 0 points, mild symptoms as 1 point, moderate symptoms as 2 points, and severe symptoms as 4 points. The child's height, weight, and BMI were also recorded.

[0068] Efficacy criteria: The efficacy criteria shown in Table 1 were formulated with reference to "Zhu Futang's Practical Pediatrics", "Pediatrics", "Expert Consensus on Diagnosis, Assessment and Management of Childhood Obesity in China", and "Guidelines for Assessment, Treatment and Prevention of Childhood Obesity in China". Specifically: Marked effect: meeting any one of the five criteria; Effective: meeting any one of the three criteria; Ineffective: meeting any one of the three criteria.

[0069] Table 1: Efficacy Criteria Statistical methods: SPSS 26.0 software was used for statistical analysis. Quantitative data conforming to a normal distribution were analyzed using... For data describing a normal distribution, parametric tests are used for comparison; for data not conforming to a normal distribution, the median (interquartile range) is used, and nonparametric tests are used for comparison. Chi-square tests are used for count data, with α=0.05 as the significance level.

[0070] The above statistical methods were used to calculate the efficacy of weight management and the efficacy of clinical symptoms according to the efficacy criteria, resulting in Tables 2 and 3.

[0071] Table 2: Results of Weight Management Therapy As shown in Table 1, the therapeutic effects of taking the Jianpi Qingshen Granules provided in Example 1 of this application on weight management were as follows: significant effect 29.76%, effective 52.38%, and total effective rate 82.14%.

[0072] Table 3: Clinical Symptoms and Treatment Results As shown in Table 1, the clinical efficacy results of taking the Jianpi Qingshen Granules provided in Example 1 of this application were as follows: significant effect 28.57%, effective 59.52%, and total effective rate 88.09%.

[0073] In this embodiment, liver function, kidney function, and routine urine tests were performed on the children before and after use to assess the safety of Jianpi Qingshen Granules. The test results are shown in Table 4.

[0074] Table 4: Liver and kidney function test data [M (P25, P75)] As shown in Table 3, after using the Jianpi Qingshen Granules provided in Example 1, the contents of ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) decreased, while the contents of urea and creatinine changed very little. This indicates that the Jianpi Qingshen Granules provided in Example 1 of this application are not toxic and can be safely used for the treatment of simple obesity in children.

[0075] To explore the relationship between the spleen-strengthening and weight-loss composition in this application and simple obesity in children, this application used the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) to retrieve the active ingredients (OB≥30%, DL≥0.18) of each drug in the spleen-strengthening and weight-loss composition. Simultaneously, it retrieved the relevant target proteins of each active ingredient in the spleen-strengthening and weight-loss composition from the TCMSP, Pubchem, STITCH, and SwissTargetPrediction databases, and retrieved target proteins related to simple obesity in children from the OMIM, Drug Bank, TTD, and CTD databases. After mapping the obtained target points of the spleen-strengthening and weight-loss composition with the target points of simple obesity in children, the intersection was taken, and a Venny diagram was drawn to obtain the attached... Figure 1 .

[0076] From the appendix Figure 1 It can be seen that a total of 946 targets of the spleen-strengthening and weight-loss composition were screened out. After mapping and taking the intersection with the targets of childhood simple obesity, a total of 396 potential therapeutic targets were obtained.

[0077] The potential targets of the spleen-strengthening and weight-regulating composition for treating simple obesity in children were analyzed and visualized using Cytoscape software. A network diagram of traditional Chinese medicine, its components, and their intersections was drawn, yielding the following results: Figure 2 From the appendix Figure 2 It is evident that the spleen-strengthening and weight-loss composition provided in Example 1 of this application has a high proportion of potential target points for treating simple obesity in children, and the core target points are closely related. This suggests that the spleen-strengthening and weight-loss composition provided in Example 1 of this application has a good therapeutic effect on simple obesity in children.

[0078] Furthermore, the DAVID database was used to perform KEGG pathway enrichment analysis on the intersection targets of the spleen-strengthening and weight-loss composition for treating simple obesity in children, and the data was visualized using R language to obtain the attached results. Figure 3 .

[0079] From the appendix Figure 3 As can be seen, the target of the spleen-strengthening and weight-loss composition provided in Example 1 of this application for treating simple obesity in children is mainly enriched in the lipid metabolism and atherosclerosis pathways, indicating that it mainly exerts its regulatory effect through the lipid metabolism pathway.

[0080] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A spleen-strengthening and body-lightening composition, characterized in that, The raw materials for preparing the spleen-strengthening and body-lightening composition include, by weight: Codonopsis pilosula 20-30g, Atractylodes macrocephala 20-30g, Poria cocos 20-30g, Pinellia ternata 8-12g, Citrus reticulata peel 10-15g, Glycyrrhiza uralensis 5-8g, Astragalus membranaceus 20-30g, Coix lacryma-jobi (fried) 20-30g, Dolichos lablab 12-18g, Stephania tetrandra 10-15g, Citrus aurantium 10-15g, Citrus medica 10-15g, Bambusa textilis 8-12g, Nelumbo nucifera leaf 10-15g, Morus alba leaf 10-15g, and Crataegus pinnatifida 10-15g.

2. The spleen-strengthening and body-lightening composition according to claim 1, characterized in that, The raw materials for preparing the spleen-strengthening and body-lightening composition include, by weight: Codonopsis pilosula 24-26g, Atractylodes macrocephala 24-26g, Poria cocos 24-26g, Pinellia ternata 9-10g, Citrus reticulata peel 11-13g, Glycyrrhiza uralensis 5-6g, Astragalus membranaceus 24-26g, Coix lacryma-jobi (fried) 24-26g, Dolichos lablab 14-16g, Stephania tetrandra 11-13g, Citrus aurantium 11-13g, Citrus medica 11-13g, Bambusa textilis 8-9g, Nelumbo nucifera leaf 11-13g, Morus alba leaf 11-13g, and Crataegus pinnatifida 11-13g.

3. The spleen-strengthening and body-lightening composition according to claim 1, characterized in that, The raw materials for preparing the spleen-strengthening and body-lightening composition include, by weight: 24g of Codonopsis pilosula, 24g of Atractylodes macrocephala, 24g of Poria cocos, 9g of Pinellia ternata, 12g of Citrus reticulata peel, 6g of Glycyrrhiza uralensis, 24g of Astragalus membranaceus, 24g of Coix lacryma-jobi (fried), 15g of Dolichos lablab, 12g of Stephania tetrandra, 12g of Citrus aurantium, 12g of Citrus medica, 9g of Bambusa textilis, 12g of Nelumbo nucifera leaf, 12g of Morus alba leaf, and 12g of Crataegus pinnatifida.

4. The spleen-strengthening and body-lightening composition according to claim 1, characterized in that, The dosage form of the spleen-strengthening and body-lightening composition is granules, tablets, capsules, or concentrated pills.

5. A method for preparing the spleen-strengthening and body-lightening composition according to any one of claims 1-4, characterized in that, When the spleen-strengthening and body-lightening composition is in the form of granules, the preparation method includes: Add Atractylodes macrocephala and dried tangerine peel to 6-10 times the amount of water, steam distill for 2-5 hours, condense and filter to obtain volatile oil, aqueous solution and dregs; The volatile oil and β-cyclodextrin were stirred and encapsulated, and then dried at 60°C to obtain the volatile oil inclusion complex; The dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, Coix lacryma-jobi (stir-fried), Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida were added to water and decocted twice. The decoctions were combined, filtered, and concentrated at 60°C to obtain a clear extract with a relative density of 1.2-1.

25. Add 3 times the amount of ethanol to the ointment, stir well, let stand for 12-18 hours, filter, and obtain the filtrate. The filtrate and the aqueous solution were combined, concentrated at 60°C to a relative density of 1.3-1.35, dried under reduced pressure, and pulverized to obtain a fine powder. The volatile oil inclusion complex, the fine powder, the soluble starch and steviol glycosides are mixed, and purified water is added in small amounts several times. The mixture is then granulated and dried to obtain spleen-strengthening and body-lightening granules.

6. A method for preparing the spleen-strengthening and body-lightening composition according to any one of claims 1-4, characterized in that, When the spleen-strengthening and weight-loss composition is in the form of tablets or capsules, the preparation method includes: Add Atractylodes macrocephala and dried tangerine peel to 6-10 times the amount of water, steam distill for 2-5 hours, condense and filter to obtain volatile oil, aqueous solution and dregs; The volatile oil and β-cyclodextrin were stirred and encapsulated, and then dried at 60°C to obtain the volatile oil inclusion complex; The dregs of the herbs, Codonopsis pilosula, Poria cocos, Pinellia ternata, Glycyrrhiza uralensis, Astragalus membranaceus, Coix lacryma-jobi (stir-fried), Dolichos lablab, Stephania tetrandra, Citrus aurantium, Citrus medica, Bambusa textilis, Nelumbo nucifera, Morus alba, and Crataegus pinnatifida were added to water and decocted twice. The decoctions were combined, filtered, and concentrated at 60°C to obtain a clear extract with a relative density of 1.2-1.

25. Add 3 times the amount of ethanol to the ointment, stir well, let stand for 12-18 hours, filter, and obtain the filtrate. The filtrate and the aqueous solution were combined, concentrated at 60°C to a relative density of 1.3-1.35, dried under reduced pressure, and pulverized to obtain a fine powder. The fine powder and microcrystalline cellulose are mixed into granules, dried, and then the volatile oil inclusion complex is added and mixed evenly. The mixture is then compressed into tablets and coated with a film to obtain spleen-strengthening and weight-loss tablets; or it is encapsulated to obtain spleen-strengthening and weight-loss capsules.

7. A method for preparing the spleen-strengthening and body-lightening composition according to any one of claims 1-4, characterized in that, When the spleen-strengthening and body-lightening composition is a concentrated pill, the preparation method includes: Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Citrus reticulata peel are ground into a fine powder; Pinellia ternata, licorice, astragalus membranaceus, stir-fried coix seed, hyacinth bean, Stephania tetrandra, immature bitter orange, citron, bamboo shavings, lotus leaf, mulberry leaf and hawthorn are added to water and decocted twice. The decoctions are combined, filtered, and concentrated at 60°C to obtain a thick paste with a relative density of 1.3-1.

35. The thick paste is dried under reduced pressure, pulverized, and then mixed with the fine powder. Water is used as a wetting agent to make pills, which are then dried to obtain a concentrated pill for strengthening the spleen and lightening the body.

8. The use of the spleen-strengthening and body-lightening composition according to any one of claims 1-4 in the preparation of a medicament for treating simple obesity in children.

9. The application according to claim 8, characterized in that, The childhood obesity described is of the spleen deficiency and phlegm-dampness type.

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