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

Abstract

The invention provides a spleen-tonifying and appetite-stimulating traditional Chinese medicine composition and a preparation method and application thereof.The spleen-tonifying and appetite-stimulating traditional Chinese medicine composition is composed of traditional Chinese medicine compound extracts A, B and C. The traditional Chinese medicine compound extract A is obtained by matching, extracting and separating radix fici simplicissimae, Chinese yam, hairyvein agrimony and coffee beans; the traditional Chinese medicine compound extract B is obtained by matching hawthorn and roxburgh rose and then extracting and separating, and the traditional Chinese medicine compound extract C is obtained by matching olive, emblic leafflower and green plum and then extracting and separating. The traditional Chinese medicine composition can promote stomach digestion of a patient, promote intestinal peristalsis, improve appetite of the patient, regulate intestinal flora of the patient, protect gastric mucosa of the patient, effectively carry out auxiliary treatment on syndromes caused by child anorexia, chronic stomach diseases and recessive stomach diseases, shorten the treatment cycle and improve the medication compliance of children, and has the advantages of being efficient in preparation process, high in medicine applicability, low in cost and the like. And popularization and implementation are facilitated.

Description

Technical Field

[0001] This application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for invigorating the spleen and promoting appetite, its preparation method and application. Background Art

[0002] In the prior art, in traditional Chinese medicine theory, the spleen is responsible for transportation and transformation. The spleen transforms the essence of food and water into qi and blood, which are distributed to all internal organs of the body. At the same time, it transports and transforms water and dampness to maintain the balance of body fluids. If the spleen fails to function properly (spleen deficiency), qi and blood production will be insufficient, resulting in loss of appetite, abdominal distension, and fatigue. The stagnation of water and dampness will generate phlegm and fluid retention, and edema. The stomach is responsible for receiving and ripening food, and the stomach qi descends smoothly, being responsible for the initial digestion of food. If the stomach qi rebels upward (disharmony of the stomach qi descending), belching, nausea, and vomiting will occur; if there is deficiency of stomach yin, there will be dry mouth and tongue, and lack of appetite despite hunger. The dynamic balance of the spleen ascending the clear and the stomach descending the turbid is the key to normal digestive function.

[0003] In the prior art, with the acceleration of the modern social life rhythm and the change of diet structure, spleen and stomach disharmony has become a common health problem. Traditional Chinese medicine theory emphasizes that "the spleen and stomach are the foundation of acquired constitution". Spleen deficiency and stomach weakness will lead to symptoms such as loss of appetite, indigestion, abdominal distension, and loose stools, seriously affecting the body's nutrient absorption and immune function.

[0004] In the prior art, some commonly used western medicines for invigorating the spleen and promoting appetite in clinical practice, such as gastric motility promoters, digestive enzyme supplements, gastric acid regulators, etc., still have certain limitations in the treatment of spleen deficiency-related symptoms such as anorexia in children, food stagnation, indigestion, and loss of appetite. For example, gastric acid regulators reduce the gastric acid secretion of patients by inhibiting the H+ / K+-ATPase of gastric parietal cells or histamine H2 receptors, reducing the stimulation of gastric acid on the mucosa, indirectly improving appetite, and temporarily relieving the discomfort symptoms caused by excessive gastric acid, but they cannot fundamentally solve the problem of spleen deficiency in patients. Long-term use may also cause side effects such as gastric mucosal atrophy and gastric acid secretion function disorder.

[0005] In the prior art, traditional Chinese medicine has unique advantages in the treatment of spleen deficiency. Its various natural medicine components can treat spleen deficiency through a multi-target synergistic mechanism. Although certain progress has been made in the research and development of existing traditional Chinese medicine compositions, there are still many limitations. For example, the components in commonly used traditional Chinese medicine compositions are numerous, and the preparation process is relatively complex, which is not conducive to batch production. Moreover, the preparation process of existing traditional Chinese medicine composition preparations is relatively traditional, with disadvantages such as low utilization rate of medicinal materials, slow absorption by patients, and poor compliance of children. Therefore, improvements are needed now. Summary of the Invention

[0006] This application aims to solve the technical problems in the prior art, where traditional Western medicines for strengthening the spleen and promoting appetite can only treat patients through a single target, with certain limitations in the treatment effect, being unable to effectively treat the syndromes caused by chronic or latent stomach diseases, having a long treatment cycle, and in the actual mass production process, although progress has been made in research and development, the formula is relatively complex, the preparation process is relatively traditional, the utilization rate of medicinal materials is low, the cost is high, and the compliance of children is poor. A traditional Chinese medicine composition for strengthening the spleen and promoting appetite, its preparation method and application are proposed.

[0007] This application adopts the following scheme. A traditional Chinese medicine composition for strengthening the spleen and promoting appetite is composed of the following components by weight: 10 - 12 parts of traditional Chinese medicine compound extract A, 5 - 8 parts of traditional Chinese medicine compound extract B, and 5 - 8 parts of traditional Chinese medicine compound extract C. The traditional Chinese medicine compound extract A is prepared by sequentially extracting Ficus hirta Vahl, Chinese yam, Agrimonia pilosa Ledeb., and coffee beans with deionized water and then precipitating with absolute ethanol. The traditional Chinese medicine compound extract B is prepared by sequentially subjecting hawthorn and Rosa roxburghii Tratt to enzymatic hydrolysis and high - speed centrifugation. The traditional Chinese medicine compound extract C is prepared by sequentially crushing, salting, and extracting with an organic phase from olive, Phyllanthus emblica Linn., and Prunus mume Sieb. et Zucc.

[0008] In the actual implementation process, the traditional Chinese medicine compound extract A can also be prepared by sequentially extracting Ficus hirta Vahl, Chinese yam, dried tangerine peel, Poria cocos Wolf., Agrimonia pilosa Ledeb., and coffee beans with deionized water and then precipitating with absolute ethanol. The traditional Chinese medicine compound extract B can also be prepared by sequentially subjecting hawthorn, carrot, malt, and Rosa roxburghii Tratt to enzymatic hydrolysis and high - speed centrifugation. The traditional Chinese medicine compound extract C can also be prepared by sequentially crushing, salting, and extracting with an organic phase from olive, Phyllanthus emblica Linn., mint, Pogostemon cablin (Blanco) Benth., and Prunus mume Sieb. et Zucc.

[0009] In some feasible embodiments, the preparation method of the traditional Chinese medicine compound extract A includes the following steps: Step 101. Dry and pulverize Ficus hirta Vahl, Chinese yam, Agrimonia pilosa Ledeb., and coffee beans to 80 meshes to obtain traditional Chinese medicine complex A. Step 102. Add the traditional Chinese medicine complex A prepared in step 101 and deionized water to the reaction kettle in a volume ratio of 1:(10 - 12). After the traditional Chinese medicine complex A is soaked for 2h - 5h, replenish (15 - 18) times the volume of deionized water, and decoct at 75℃ - 90℃ and 200rpm - 500rpm for 2h - 5h. After cooling and filtering, rotary - evaporate the filtrate into extract A with a relative density of 1.05 - 1.10. Step 103. Add absolute ethanol to the extract A prepared in Step 102. Under the conditions of room temperature, 600 rpm, and -0.01 MPa, stir for 30 min - 50 min, then let it stand for precipitation for 12 h - 24 h, filter off the supernatant, and freeze-dry the lower-layer extract to obtain the Chinese medicine composite extract A.

[0010] In some feasible embodiments, the preparation method of the Chinese medicine composite extract B includes the following steps: Step 201. Remove the cores from hawthorns and rosa roxburghii tratt, dry them, and crush and grind them to 100 mesh to obtain the Chinese medicine complex B. Step 202. Add the Chinese medicine complex B, pectinase, and deionized water prepared in Step 201 to the reaction kettle in a mass ratio of 5:0.8:(12 - 16) in sequence. Under the conditions of a water bath at 47 °C and 50 rpm, carry out enzymatic hydrolysis for 50 min - 100 min. During the enzymatic hydrolysis process, dropwise add acetic acid to the reaction kettle to make the pH of the reaction system 5 during the enzymatic hydrolysis process. After the enzymatic hydrolysis is completed, obtain the crude extract B. Step 203. Add excessive n-hexane to the crude extract B prepared in Step 202. After shaking extraction, removing the supernatant, and filtering in sequence, obtain the intermediate extract B. Step 204. Add excessive acetone to the intermediate extract B prepared in Step 203, and carry out premixing under the conditions of an ice bath at 0 °C - 5 °C, 1200 rpm, and a nitrogen atmosphere. After the premixing is completed, transfer the mixed system to a high-speed centrifuge, and under the conditions of an ice bath at 0 °C - 5 °C and 12000 rpm - 15000 rpm, centrifuge for 10 min - 15 min. After the centrifugation is completed, the supernatant is rotary evaporated and then fixed with pure water for storage to obtain the Chinese medicine composite extract B.

[0011] In this application, "excessive" means that the volume ratio of substance a to substance b is greater than 2.5.

[0012] In this application, "appropriate amount" means a pharmaceutically acceptable dosage.

[0013] In some feasible embodiments, the preparation method of the Chinese medicine composite extract C includes the following steps: Step 301. Put the crushed greengage, phyllanthus emblica, olive, and composite salt into the stirring kettle in sequence. Under the conditions of a water bath at 10 °C - 15 °C and 200 rpm, stir for 10 min - 20 min to obtain the Chinese medicine premix C. Step 302. Transfer the Chinese medicine premix C prepared in Step 301 to the oven, spread the Chinese medicine premix C along the length direction of the oven, dry it at 35 °C - 40 °C for 48 h - 72 h, and then successively carry out deionized water washing, moisture drying, core removal, freeze-drying, and crushing and grinding to 80 mesh to obtain the Chinese medicine complex C. Step 303. Put the traditional Chinese medicine complex C, glacial acetic acid, and absolute ethanol prepared in Step 302 into an ultrasonic reactor according to a mass ratio of 1:(1.5 - 2.3):(10 - 13), and react for 35 minutes under the conditions of an ice bath at 0°C - 5°C and an ultrasonic frequency of 30 kHz - 35 kHz to obtain the pre-extract C; Step 304. Transfer the pre-extract C prepared in Step 303 to a high-speed centrifuge, centrifuge for 10 minutes under the conditions of an ice bath at 0°C - 5°C and 12000 rpm - 15000 rpm, take the supernatant, and then successively extract with ethyl acetate and rotary evaporate to remove ethyl acetate to obtain the traditional Chinese medicine compound extract C.

[0014] In some feasible embodiments, in Step 301, the composite salt is obtained by mixing sodium chloride, zinc chloride, and sodium bicarbonate according to a mass ratio of 5:0.5:1.

[0015] In some feasible embodiments, the mass ratio of Ficus hirta, Chinese yam, Agrimonia pilosa, and coffee beans in the traditional Chinese medicine compound extract A is (3.3 - 4.6):(1.5):(2.2 - 3.2):(1.8 - 2.7); The mass ratio of hawthorn and Rosa roxburghii tratt in the traditional Chinese medicine compound extract B is (2.5 - 3.2):4; The mass ratio of olives, Phyllanthus emblica, and greengage in the traditional Chinese medicine compound extract C is (2.6 - 3.8):(3.5 - 4.2):(4.6 - 5.2).

[0016] In the actual implementation process, the traditional Chinese medicine compound extract A is prepared by extraction with deionized water and precipitation with absolute ethanol, which can effectively avoid the destruction of Agrimonia pilosa polysaccharide by high temperature and fully extract the alkaloids of coffee beans, realizing the compatibility decocting logic of "using gentle fire to extract sweetness and strong fire to extract bitterness".

[0017] The traditional Chinese medicine compound extract B is prepared by enzymatic hydrolysis and high-speed centrifugation, which can fully decompose the pectin in the cell walls of hawthorn and Rosa roxburghii tratt, release organic acids, and cause less loss of vitamin C in Rosa roxburghii tratt (pH = 5 protects the stability of VC), reflecting the compatibility and synergistic effect of "enzymes assisting the medicinal properties".

[0018] The preparation of the traditional Chinese medicine compound extract C by crushing, salting, and organic phase extraction can reduce the oxidation of heat-sensitive organic acids (such as citric acid) in greengage, and form a synergistic effect of "preserving acids at low temperature and salt assisting penetration" with the osmotic effect of the composite salt.

[0019] To solve the technical problems proposed in this application, this application also provides an application of a spleen-strengthening and appetite-promoting traditional Chinese medicine composition, which is used to prepare a spleen-strengthening and appetite-promoting drug, and the spleen-strengthening and appetite-promoting drug is used to improve infantile anorexia, improve appetite, promote digestion, regulate the intestinal flora, and repair the gastric mucosa.

[0020] In some feasible embodiments, the spleen-strengthening and appetite-promoting drug comprises a pharmaceutically acceptable excipient and the above-mentioned spleen-strengthening and appetite-promoting traditional Chinese medicine composition; The preparation method of the spleen-strengthening and appetite-promoting drug comprises the following steps: after mixing Chinese medicine extract A, Chinese medicine extract B, Chinese medicine extract C and a pharmaceutically acceptable excipient, the spleen-strengthening and appetite-promoting drug is prepared according to the target dosage form.

[0021] Compared with the prior art, the present application has the following beneficial effects: The present application provides a spleen-strengthening and appetite-promoting traditional Chinese medicine composition, a preparation method and an application thereof. The spleen-strengthening and appetite-promoting traditional Chinese medicine composition is composed of traditional Chinese medicine compound extracts A, B and C. The traditional Chinese medicine compound extract A is obtained by proportioning, extracting and separating Ficus hirta, Chinese yam, Agrimony pilosa Ledeb. and coffee beans. The traditional Chinese medicine compound extract B is obtained by proportioning, extracting and separating hawthorn and Rosa roxburghii Tratt. The traditional Chinese medicine compound extract C is obtained by proportioning, extracting and separating Chinese olive, Phyllanthus emblica Linn. and Prunus mume Sieb. et Zucc. By proportioning, extracting and separating a variety of medicinal materials and making them into drugs, it can promote gastric digestion of patients, promote intestinal peristalsis, boost the appetite of patients, regulate the intestinal flora of patients, protect the gastric mucosa of patients, effectively assist in the treatment of syndromes caused by infantile anorexia, chronic gastropathy and latent gastropathy, shorten the treatment cycle, improve the drug compliance of children, and has the advantages of high preparation efficiency, strong drug applicability and convenient promotion and implementation. Description of the Drawings

[0022] Figure 1 is the body weight growth curve of mice in Examples 1-3 and Comparative Examples 1-3 of the present application; Figure 2 is the body weight growth curve of mice in Example 2, Comparative Examples 4-6, Comparative Example 10 and the blank control group of the present application; Figure 3 is the body weight growth curve of mice in Example 2, Comparative Examples 7-10 and the blank control group of the present application. Detailed Embodiments

[0023] Combined with Figures 1-3 Examples 1-3 and Comparative Examples 1-10, the technical solution provided by the present application is further described. The medicinal materials used in the present application can be directly purchased from the market. For example: Ficus hirta is the dried root of Ficus hirta Vahl, a plant of the genus Ficus in the family Moraceae. It can be harvested throughout the year, washed, sliced and dried in the sun.

Properties and flavors

Meridians entered

Functions and indications

[0024] Yam is the dried rhizome of Dioscorea opposita Thunb. of the Dioscoreaceae family. It is harvested in autumn, the above-ground parts and fibrous roots are removed, washed, the outer skin is scraped off, and then dried in the sun or by drying, or sliced fresh and dried.

Properties and Flavors

Meridians Entered

Functions and Indications

[0025] Agrimony is the dried whole herb of Agrimonia pilosa Ledeb. of the Rosaceae family. It is cut before flowering or at the early flowering stage in summer, impurities are removed, and it is dried in the sun or in the shade.

Properties and Flavors

Meridians Entered

Functions and Indications

[0026] Hawthorn is the dried ripe fruit of Crataegus pinnatifida var. major N. E. Br. of the Rosaceae family. It is harvested when the fruit is ripe in autumn, sliced, and dried.

Properties and Flavors

Meridians Entered

Functions and Indications

[0027] Coffee bean is the dried ripe seed of Coffea arabica L. of the Rubiaceae family. It is harvested when the fruit is ripe, dried in the sun or by drying, the pericarp and seed coat are removed, and impurities are sifted out.

Properties and Flavors

Functions and Indications

[0028] Roxburgh rose fruit is the dried ripe fruit of Rosa roxburghii Tratt. of the Rosaceae family. It is harvested when the fruit is ripe in autumn, impurities are removed, and it is dried in the sun or in the shade.

Properties and Flavors

Meridians Entered

Functions and Indications

[0029] Chinese olive is the dried fruit of Canarium album (Lour.) Rauesch. of the Burseraceae family. It is generally harvested when the fruit is ripe from August to November, washed, and used fresh or dried over a low fire.

Properties and Flavors

Meridians Entered

Functions and Indications

[0030] Vatica fruit is the dried unripe fruit of Vatica mangachapoi Blanco of the Dipterocarpaceae family. It is collected in summer, the fruit is dried in the sun or by drying, and impurities are removed.

Properties and Flavors

Meridians Entered

Functions and Indications

[0031] The Phyllanthus emblica fruit is the dried and mature fruit of Phyllanthus emblica L. of the Euphorbiaceae family. It is harvested when the fruit is mature in winter, impurities are removed, and it is dried in the sun or by drying.

Properties

Meridians entered

Functions and indications

[0032] Example 1 (1) According to the component table shown in Table 1, the preparation method of the traditional Chinese medicine compound extract A includes the following steps: Step 101. After drying and pulverizing and grinding Ficus hirta, Chinese yam, Agrimonia pilosa, and coffee beans to 80 mesh, the traditional Chinese medicine complex A is obtained; Step 102. The traditional Chinese medicine complex A prepared in Step 101 and deionized water are successively added to the reaction kettle according to a volume ratio of 1:10. After the traditional Chinese medicine complex A is soaked for 2.5 h, 15 times the volume of deionized water is replenished again, and it is decocted for 2 h under the conditions of 78 °C and 280 rpm. After cooling and filtering, the filtrate is rotary evaporated into an extract A with a relative density of 1.05; Step 103. Anhydrous ethanol is added to the extract A prepared in Step 102. Under the conditions of room temperature, 600 rpm, and -0.01 MPa, after stirring for 38 min, it is left to stand and precipitate for 14 h, and then the upper clear liquid is filtered off. After the lower layer extract is freeze-dried, the traditional Chinese medicine compound extract A is obtained.

[0033] (2) The preparation method of the traditional Chinese medicine compound extract B includes the following steps: Step 201. According to the component table shown in Table 1, after removing the cores of hawthorn and Rosa roxburghii, drying and pulverizing and grinding them to 100 mesh, the traditional Chinese medicine complex B is obtained; Step 202. The traditional Chinese medicine complex B, pectinase, and deionized water prepared in Step 201 are successively added to the reaction kettle according to a mass ratio of 5:0.8:12. Under the conditions of a water bath at 47 °C and 50 rpm, enzymatic hydrolysis is carried out for 55 min. During the enzymatic hydrolysis process, acetic acid is gradually added dropwise to the reaction kettle to make the pH of the reaction system 5 during the enzymatic hydrolysis process. After the enzymatic hydrolysis is completed, the crude extract B is obtained; Step 203. Excessive n-hexane is added to the crude extract B prepared in Step 202. After shaking extraction, removing the upper clear liquid and filtering, the intermediate extract B is obtained; Step 204. Excessive acetone is added to the intermediate extract B prepared in Step 203, and premixing is carried out under the conditions of an ice bath at 1 °C, 1200 rpm, and a nitrogen atmosphere. After the premixing is completed, the mixed system is transferred to a high-speed centrifuge and centrifuged for 10 min under the conditions of an ice bath at 1 °C and 12000 rpm. After centrifugation is completed, the upper clear liquid is successively rotary evaporated to dryness and fixed volume with pure water for storage, and the traditional Chinese medicine compound extract B is obtained.

[0034] (3) The preparation method of the traditional Chinese medicine compound extract C comprises the following steps: Step 301. According to the component table shown in Table 1, put the crushed greengage, phyllanthus emblica, olive and compound salt into the stirring kettle in sequence. After stirring for 12 min under the conditions of a water bath at 10 °C and 200 rpm, the traditional Chinese medicine premix C is obtained; The compound salt is obtained by mixing sodium chloride, zinc chloride and sodium bicarbonate according to a mass ratio of 5:0.5:1; The total volume ratio of greengage, phyllanthus emblica and olive to the total volume of the compound salt is 1:13.5; Step 302. Transfer the traditional Chinese medicine premix C prepared in Step 301 to an oven, and spread the traditional Chinese medicine premix C along the length direction of the oven. After drying for 48 h at 35 °C, it is successively subjected to deionized water washing, moisture drying, stone removal, freeze drying, and pulverization and grinding to 80 meshes, and then the traditional Chinese medicine complex C is obtained; Step 303. Put the traditional Chinese medicine complex C, glacial acetic acid and absolute ethanol prepared in Step 302 into an ultrasonic reaction kettle according to a mass ratio of 1:1.5:10. After reacting for 35 min under the conditions of an ice bath at 1 °C and an ultrasonic frequency of 30 kHz, the pre-extract C is obtained; Step 304. Transfer the pre-extract C prepared in Step 303 to a high-speed centrifuge. After centrifuging for 10 min under the conditions of an ice bath at 1 °C and 12,000 rpm, take the supernatant, and then successively carry out ethyl acetate extraction and rotary evaporation to remove ethyl acetate, and then the traditional Chinese medicine compound extract C is obtained.

[0035] (4) The preparation method of the spleen-strengthening and appetite-promoting medicine comprises the following steps: According to the component table shown in Table 2, mix the traditional Chinese medicine compound extracts A, B, C and an appropriate amount of starch evenly and press them into tablets, and then the spleen-strengthening and appetite-promoting medicine is obtained.

[0036] Example 2 (1) According to the component table shown in Table 1, the preparation method of the traditional Chinese medicine compound extract A comprises the following steps: Step 101. Dry and pulverize and grind the ficus hirta, Chinese yam, agrimony and coffee beans to 80 meshes, and then the traditional Chinese medicine complex A is obtained; Step 102. Add the traditional Chinese medicine complex A prepared in Step 101 and deionized water into the reaction kettle in a volume ratio of 1:11 in sequence. After the traditional Chinese medicine complex A is soaked for 3 h, add 16 times the volume of deionized water again, and decoct for 3 h under the conditions of 85 °C and 350 rpm. After cooling and filtering, rotary evaporate the filtrate into an extract A with a relative density of 1.1; Step 103. Add absolute ethanol to the extract A prepared in Step 102. Stir for 40 min at room temperature, 600 rpm, and -0.01 MPa. After standing and precipitating for 18 h, filter off the supernatant. Freeze-dry the lower-layer extract to obtain the Chinese medicine composite extract A.

[0037] (2) The preparation method of the Chinese medicine composite extract B includes the following steps: Step 201. According to the component table shown in Table 1, remove the cores of hawthorn and rosa roxburghii tratt, dry and crush them, and grind them to 100 meshes to obtain the Chinese medicine complex B. Step 202. Add the Chinese medicine complex B, pectinase, and deionized water prepared in Step 201 to the reaction kettle in a mass ratio of 5:0.8:14 in sequence. Carry out enzymatic hydrolysis at 47°C in a water bath and 50 rpm for 80 min. During the enzymatic hydrolysis process, dropwise add acetic acid to the reaction kettle to make the pH of the reaction system 5 during the enzymatic hydrolysis process. After the enzymatic hydrolysis is completed, obtain the crude extract B. Step 203. Add excessive n-hexane to the crude extract B prepared in Step 202. After oscillating extraction, removing the supernatant, and filtering in sequence, obtain the intermediate extract B. Step 204. Add excessive acetone to the intermediate extract B prepared in Step 203, and carry out premixing in an ice bath at 3°C, 1200 rpm, and in a nitrogen atmosphere. After the premixing is completed, transfer the mixed system to a high-speed centrifuge and centrifuge at 14000 rpm in an ice bath at 3°C for 13 min. After the centrifugation is completed, the supernatant is rotary evaporated and then fixed with pure water and stored to obtain the Chinese medicine composite extract B.

[0038] (3) The preparation method of the Chinese medicine composite extract C includes the following steps: Step 301. According to the component table shown in Table 1, put the crushed greengage, phyllanthus emblica, olive, and composite salt into the stirring kettle in sequence. Stir at 12°C in a water bath and 200 rpm for 15 min to obtain the Chinese medicine premix C. The composite salt is obtained by mixing sodium chloride, zinc chloride, and sodium bicarbonate in a mass ratio of 5:0.5:1. The total volume ratio of greengage, phyllanthus emblica, and olive to the total volume of the composite salt is 1:13.5. Step 302. Transfer the Chinese medicine premix C prepared in Step 301 to the oven, spread the Chinese medicine premix C along the length direction of the oven, dry it at 37°C for 55 h, and then carry out deionized water washing, moisture drying, core removal, freeze-drying, and crushing and grinding to 80 meshes in sequence to obtain the Chinese medicine complex C. Step 303. Put the traditional Chinese medicine complex C, glacial acetic acid, and absolute ethanol prepared in Step 302 into an ultrasonic reactor according to a mass ratio of 1:2:11, and react for 35 min under the conditions of an ice bath at 3°C and an ultrasonic frequency of 32 kHz to obtain the pre-extract C. Step 304. Transfer the pre-extract C prepared in Step 303 to a high-speed centrifuge, centrifuge for 10 min under the conditions of an ice bath at 3°C and 13,000 rpm, take the supernatant, and then successively extract with ethyl acetate and rotary evaporate to remove ethyl acetate to obtain the traditional Chinese medicine compound extract C.

[0039] (4) The preparation method of the spleen-strengthening and appetite-improving medicine includes the following steps: According to the component table shown in Table 2, mix the traditional Chinese medicine compound extracts A, B, and C and an appropriate amount of starch evenly and press them into tablets to obtain the spleen-strengthening and appetite-improving medicine.

[0040] Example 3 (1) According to the component table shown in Table 1, the preparation method of the traditional Chinese medicine compound extract A includes the following steps: Step 101. Dry, crush, and grind the Ficus hirta, Chinese yam, Agrimonia pilosa, and coffee beans to 80 meshes to obtain the traditional Chinese medicine complex A. Step 102. Add the traditional Chinese medicine complex A prepared in Step 101 and deionized water to the reaction kettle in a volume ratio of 1:12 in sequence. After the traditional Chinese medicine complex A is soaked for 5 h, add 18 times the volume of deionized water again, and decoct for 5 h at 90°C and 500 rpm. After cooling and filtering, rotary evaporate the filtrate into an extract A with a relative density of 1.1. Step 103. Add absolute ethanol to the extract A prepared in Step 102, stir for 50 min at room temperature, 600 rpm, and -0.01 MPa, then let it stand for precipitation for 24 h, filter out the supernatant, and freeze-dry the lower-layer extract to obtain the traditional Chinese medicine compound extract A.

[0041] (2) The preparation method of the traditional Chinese medicine compound extract B includes the following steps: Step 201. According to the component table shown in Table 1, remove the cores of hawthorn and Rosa roxburghii tratt, dry, and crush and grind them to 100 meshes to obtain the traditional Chinese medicine complex B. Step 202. Add the traditional Chinese medicine complex B, pectinase, and deionized water prepared in Step 201 to the reaction kettle in a mass ratio of 5:0.8:16 in sequence, enzymatically hydrolyze at 47°C in a water bath and 50 rpm for 100 min. During the enzymatic hydrolysis process, dropwise add acetic acid to the reaction kettle to adjust the pH of the reaction system to 5 during the enzymatic hydrolysis process. After the enzymatic hydrolysis is completed, obtain the crude extract B. Step 203. Add excessive n-hexane to the crude extract B prepared in Step 202. After shaking extraction, removing the upper clear liquid, and filtering in sequence, the intermediate extract B is obtained. Step 204. Add excessive acetone to the intermediate extract B prepared in Step 203, and perform premixing under the conditions of an ice bath at 5°C, 1200 rpm, and a nitrogen atmosphere. After the premixing is completed, transfer the mixed system to a high-speed centrifuge and centrifuge for 15 minutes under the conditions of an ice bath at 5°C and 15000 rpm. After centrifugation, the upper clear liquid is rotary evaporated to dryness in sequence and then fixed volume with pure water for storage, and the traditional Chinese medicine composite extract B is obtained.

[0042] (3) The preparation method of the traditional Chinese medicine composite extract C includes the following steps: Step 301. According to the component table shown in Table 1, put the crushed greengage, Phyllanthus emblica, olive, and composite salt into the stirring kettle in sequence. After stirring for 20 minutes under the conditions of a water bath at 15°C and 200 rpm, the traditional Chinese medicine premix C is obtained. Among them, the composite salt is obtained by mixing sodium chloride, zinc chloride, and sodium bicarbonate according to a mass ratio of 5:0.5:1. Among them, the total volume ratio of the greengage, Phyllanthus emblica, and olive to the total volume of the composite salt is 1:13.5. Step 302. Transfer the traditional Chinese medicine premix C prepared in Step 301 to the oven, and spread the traditional Chinese medicine premix C along the length direction of the oven. After drying at 40°C for 72 hours, it is washed with deionized water, dried, pitted, freeze-dried, and ground to 80 meshes in sequence, and the traditional Chinese medicine composite C is obtained. Step 303. Put the traditional Chinese medicine composite C, glacial acetic acid, and absolute ethanol prepared in Step 302 into the ultrasonic reaction kettle according to a mass ratio of 1:2.3:13. React for 35 minutes under the conditions of an ice bath at 5°C and an ultrasonic frequency of 35 kHz, and the pre-extract C is obtained. Step 304. Transfer the pre-extract C prepared in Step 303 to a high-speed centrifuge and centrifuge for 10 minutes under the conditions of an ice bath at 5°C and 15000 rpm. Then take the upper clear liquid, and after ethyl acetate extraction and rotary evaporation to remove ethyl acetate in sequence, the traditional Chinese medicine composite extract C is obtained.

[0043] In some feasible embodiments, in Step 301, the composite salt is obtained by mixing sodium chloride, zinc chloride, and sodium bicarbonate according to a mass ratio of 5:0.5:1.

[0044] (4) The preparation method of the spleen-strengthening and appetite-improving drug includes the following steps: According to the component table shown in Table 2, mix the traditional Chinese medicine composite extracts A, B, and C and an appropriate amount of starch evenly and press them into tablets, and the spleen-strengthening and appetite-improving drug is obtained.

[0045] Comparative Example 1 The difference between Comparative Example 1 and Example 2 is that the Chinese medicine compound extract A in the spleen - strengthening and appetite - promoting medicine is removed, and the processes of the remaining components remain unchanged.

[0046] Comparative Example 2 The difference between Comparative Example 2 and Example 2 is that the Chinese medicine compound extract B in the spleen - strengthening and appetite - promoting medicine is removed, and the processes of the remaining components remain unchanged.

[0047] Comparative Example 3 The difference between Comparative Example 3 and Example 2 is that the Chinese medicine compound extract C in the spleen - strengthening and appetite - promoting medicine is removed, and the processes of the remaining components remain unchanged.

[0048] Comparative Example 4 The difference between Comparative Example 4 and Example 2 is that Agrimonia pilosa in the Chinese medicine compound extract A is removed, and the processes of the remaining components remain unchanged.

[0049] Comparative Example 5 The difference between Comparative Example 5 and Example 2 is that coffee beans in the Chinese medicine compound extract A are removed, and the processes of the remaining components remain unchanged.

[0050] Comparative Example 6 The difference between Comparative Example 6 and Example 2 is that Rosa roxburghii in the Chinese medicine compound extract B is removed, and the processes of the remaining components remain unchanged.

[0051] Comparative Example 7 The difference between Comparative Example 7 and Example 2 is that Vatica mangachapoi in the Chinese medicine compound extract C is removed, and the processes of the remaining components remain unchanged.

[0052] Comparative Example 8 The difference between Comparative Example 8 and Example 2 is that Canarium album in the Chinese medicine compound extract C is removed, and the processes of the remaining components remain unchanged.

[0053] Comparative Example 9 The difference between Comparative Example 9 and Example 2 is that Phyllanthus emblica in the Chinese medicine compound extract C is removed, and the processes of the remaining components remain unchanged.

[0054] Comparative Example 10 The difference between Comparative Example 10 and Example 2 is that domperidone is used to replace the spleen - strengthening and appetite - promoting medicine.

[0055] Table 1 Component Tables of Each Chinese Medicine Compound Extract in Examples 1 - 3 and Comparative Examples 4 - 9 Continued Table 1 Table 2 Component Tables of the Spleen - Strengthening and Appetite - Promoting Medicines in Examples 1 - 3 and Comparative Examples 1 - 3 The spleen - strengthening and appetite - promoting drugs prepared in Examples 1 - 3 and the spleen - strengthening and appetite - promoting drug substitute in Comparative Example 10 were subjected to the following tests: 140 Kunming mice at 5 weeks of age, with half males and half females, weighing 20 g - 30 g, were randomly divided into 14 groups. Each group of mice was fed twice a day at 8:00 am and 8:00 pm, and each time they were fed 100 g of basic mouse food + 10 g / kg of the drug to be tested. 4 hours before the start of the test, the mice were fasted and water - deprived to empty their stomachs, and they were fed for a total of 5 weeks; Further, in groups 1 - 3, the drugs to be tested were the spleen - strengthening and appetite - promoting drugs prepared in Examples 1 - 3 respectively; in groups 4 - 12, the drugs to be tested were the spleen - strengthening and appetite - promoting drugs prepared in Comparative Examples 1 - 9 respectively; in group 13, the drug to be tested was domperidone, and its dosage was adjusted to 0.3 g / kg; group 14 was the blank control group, and the drug to be tested was starch.

[0056] The daily food consumption and excrement output of each group of mice were recorded every day. The average weight of each group of mice was measured at the same time every five days, and the measured data were plotted into a trend graph showing changes over time. The test results are shown in Tables 3 - 5 and Figures 1-3 as follows.

[0057] Table 3. Weight gain trend table of mice in Examples 1 - 3, Comparative Examples 1 - 10 and blank control group (unit: g, average value of 10 mice per group) Table 4. Daily average food intake of mice in Examples 1 - 3, Comparative Examples 1 - 10 and blank control group (unit: g, average value of 10 mice per group) Table 5. Daily average fecal output of mice in Examples 1 - 3, Comparative Examples 1 - 10 and blank control group (unit: g, average value of 10 mice per group) From the above test results, in Examples 1 - 3, the monarch drug in the traditional Chinese medicine compound extract A is Ficus hirta (invigorating the spleen and tonifying the lung) and Agrimonia pilosa (tonifying qi and promoting dampness elimination). The two work together to achieve the effect of invigorating the spleen and replenishing qi; the ministerial drug is Dioscorea opposita (nourishing the spleen and stomach), which is combined with the monarch drug to enhance the spleen - strengthening function of the monarch drug, and at the same time relieve the irritation of the adjuvant drug coffee bean; the adjuvant drug is coffee bean (bitter and cold, promoting gastric acid secretion), which is combined with the sweet - warm Agrimonia pilosa to form a "balance between cold and heat", avoiding qi stagnation caused by excessive warming and tonifying.

[0058] The monarch drug in the traditional Chinese medicine compound extract B is Hawthorn (sour and sweet, promoting digestion and resolving food stagnation). The ministerial drug is Rosa roxburghii (astringent and sour, rich in vitamin C), and its sour taste is combined with the sour taste of Hawthorn to form "transforming yin with sour and sweet", relieving mucosal damage caused by excessive gastric acid.

[0059] In the compound traditional Chinese medicine extract C, the monarch drug is greengage (sour and astringent, promoting the production of body fluids and stopping diarrhea), which can regulate the acid-base balance of the intestine. The ministerial drugs are Phyllanthus emblica (bitter and sweet, clearing heat and detoxifying) and Chinese olive (sweet and neutral, moistening the intestine). The combination of sour, bitter, and sweet flavors conforms to the principle of regulating the qi movement of the intestine of "pungent opening, bitter descending, and sweet harmonizing". The adjuvant drug is the compound salt (sodium chloride + sodium bicarbonate), which promotes the secretion of intestinal water through osmotic pressure, softens the feces in combination with the monarch drug and the ministerial drugs, and further increases the excretion volume of mice.

[0060] By combining the compound traditional Chinese medicine extract B with the compound traditional Chinese medicine extract A, the content of coffee beans in the drug can be ensured, the alkaloids in the coffee beans can be alleviated, the side effects of the coffee beans can be reduced, the intestinal peristalsis of mice can be promoted, the defecation volume of mice can be significantly increased, the appetite of mice can be significantly increased, the daily food intake of mice can be increased, and the intestinal flora can be activated in combination with the compound traditional Chinese medicine extract C, the nutrient absorption efficiency can be improved, and the body weight of mice can be significantly increased.

[0061] In Comparative Example 1, the spleen-strengthening basis of the compound traditional Chinese medicine extract A is missing, resulting in "water without a source", that is, the compound traditional Chinese medicine extract B and the compound traditional Chinese medicine extract C cannot play the roles of appetizing and promoting intestinal peristalsis in the state of spleen deficiency, and the food intake and weight gain of mice both stagnate.

[0062] In Comparative Example 2, the compound traditional Chinese medicine extract B is missing, and the appetizing power is missing. Even if the compound traditional Chinese medicine extract A tonifies the spleen and the compound traditional Chinese medicine extract C promotes intestinal peristalsis, the nutritional intake cannot be achieved due to lack of appetite. In Comparative Example 2, the food intake of mice is close to the blank control.

[0063] In Comparative Example 3, the compound traditional Chinese medicine extract C is missing, and the qi movement of the intestine is disordered. Although the compound traditional Chinese medicine extract A and the compound traditional Chinese medicine extract B promote digestion and absorption, the unsmooth excretion leads to the accumulation of metabolic wastes, forming the side effect of "excessive supplementation and stagnation".

[0064] In Comparative Example 4, Agrimonia pilosa in the compound traditional Chinese medicine extract A is removed. The compound traditional Chinese medicine extract A lacks the core qi-tonifying component. Ficus hirta Vahl used alone is partial to dispelling dampness, and Dioscorea opposita Thunb has weak tonifying power. The compatibility becomes "having ministerial drugs without a monarch drug", and the spleen-strengthening effect is greatly reduced.

[0065] In Comparative Example 5, the coffee beans in the compound traditional Chinese medicine extract A are removed, breaking the cold-heat balance of the compound traditional Chinese medicine extract A. The sweet-warm nature of Agrimonia pilosa and Dioscorea opposita Thunb is not restricted by the bitter-cold, which may lead to qi stagnation and heat transformation. The defecation volume of mice decreases, and the patient has a risk of constipation.

[0066] In Comparative Example 6, Rosa roxburghii in the compound traditional Chinese medicine extract B is removed. The phenolic substances in the compound traditional Chinese medicine extract C decrease, and the antioxidant function of the compound traditional Chinese medicine extract B is missing. The organic acids of Crataegus pinnatifida Bunge may damage the gastric mucosa during long-term use, reducing the food intake of mice, and then causing subsequent diseases. There is a risk of gastric perforation during long-term use.

[0067] In Comparative Example 7, Japanese apricot in the traditional Chinese medicine compound extract C was removed, resulting in the absence of the monarch drug in the traditional Chinese medicine compound extract C. As a result, the traditional Chinese medicine compound extract C lost its dual regulating ability of astringing the intestines with sourness and promoting the production of body fluid, which was likely to cause intestinal dehydration.

[0068] In Comparative Example 8, Chinese olive in the traditional Chinese medicine compound extract C was removed, resulting in the absence of the moistening and sweetening effect of Chinese olive. The osmotic pressure stimulation of the compound salt was not neutralized, which might cause abdominal pain.

[0069] In Comparative Example 9, Phyllanthus emblica in the traditional Chinese medicine compound extract C was removed, resulting in the absence of the function of clearing heat with bitter cold of Phyllanthus emblica. The synergy of the sour and astringent taste of Japanese apricot and the osmotic pressure of the compound salt might cause excessive astringency, leading to constipation.

[0070] In Comparative Example 10, domperidone (motilium), a western medicine, is a single dopamine receptor antagonist. Although it can promote gastric emptying in the short term, its action mode is relatively single. Long-term use may cause deficiency of the spleen and stomach (the weight gain rate slowed down in the middle and late stages of the experiment), and excessive gastric motility may cause intestinal spasm (reducing the defecation volume).

[0071] The above are the embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A spleen-strengthening and appetite-stimulating Chinese medicine composition, characterized in that: The composition is composed of the following components by weight: 10-12 parts of Chinese medicine compound extract A, 5-8 parts of Chinese medicine compound extract B and 5-8 parts of Chinese medicine compound extract C; The Chinese medicine composite extract A is prepared by extracting Prunus mume, Chinese yam, Agrimony vine and coffee beans in sequence with deionized water and precipitating with anhydrous ethanol; The Chinese medicine composite extract B is prepared by enzymatic hydrolysis and high-speed centrifugation of hawthorn and roxburghii; The traditional Chinese medicine composite extract C is prepared by crushing olives, oranges and green plums, followed by salting and organic phase extraction.

2. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 1, characterized in that: The preparation method of the Chinese medicine composite extract A comprises the following steps: Step 101. Dry the quinquefolius, yam, agrimony and coffee beans, and grind them into 80 meshes to obtain the traditional Chinese medicine complex A; Step 102. The Chinese medicine complex A and deionized water prepared in step 101 are sequentially added to the reaction kettle. After the Chinese medicine complex A is soaked for 2h-5h, deionized water is added again and boiled for 2h-5h at 75°C-90°C and 200rpm-500rpm. After cooling and filtering, the filtrate is rotary evaporated to obtain an extract A with a relative density of 1.05-1.10; Step 103. Add anhydrous ethanol to the extract A prepared in step 102, stir for 30 min-50 min at room temperature, 600 rpm, and -0.01 MPa, let it stand for 12 h-24 h, filter out the upper clear liquid, and freeze-dry the lower extract to obtain the Chinese medicine composite extract A.

3. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 2, characterized in that: In step 102, the volume ratio of the Chinese medicine complex A to deionized water is 1:(10-12); In step 102, the volume ratio of the Chinese medicine complex A to the deionized water added again is 1:(15-18).

4. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 1, characterized in that: The preparation method of the Chinese medicine composite extract B comprises the following steps: Step 201. Remove the cores of hawthorn and roxburghii, dry them, and grind them into 100 meshes to obtain the Chinese medicine complex B; Step 202. The traditional Chinese medicine complex B prepared in step 201, pectinase and deionized water are sequentially added into a reactor, and enzymolysis is performed in a water bath at 47° C. and 50 rpm for 50 min-100 min. During the enzymolysis process, acetic acid is added dropwise into the reactor. After the enzymolysis is completed, a crude extract B is obtained; Step 203. Add excess n-hexane to the crude extract B prepared in step 202, extract by oscillation, remove the supernatant and filter, to obtain an intermediate extract B; Step 204. Add excess acetone to the intermediate extract B prepared in step 203, and premix in an ice bath at 0°C-5°C, 1200rpm, and nitrogen atmosphere. After the premixing is completed, transfer the mixed system to a high-speed centrifuge, and centrifuge for 10min-15min in an ice bath at 0°C-5°C, 12000rpm-15000rpm. After the centrifugation is completed, the supernatant is successively rotary evaporated and stored in pure water to obtain the traditional Chinese medicine composite extract B.

5. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 4, characterized in that: In step 202, the mass ratio of the Chinese medicine compound B, pectinase and deionized water is 5:0.8:(12-16); In step 202, acetic acid is added dropwise into the reaction kettle to make the pH of the reaction system equal to 5 during the enzymatic hydrolysis process.

6. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 1, characterized in that: The preparation method of the Chinese medicine composite extract C comprises the following steps: Step 301. Put the crushed greengage, orange, olive and composite salt into a stirring kettle in sequence, and stir for 10-20 minutes in a water bath at 10°C-15°C and 200 rpm to obtain a Chinese medicine premix C; Step 302. The Chinese medicine premix C prepared in step 301 is transferred to an oven, and the Chinese medicine premix C is spread along the length direction of the oven, dried at 35° C. to 40° C. for 48 h to 72 h, and then sequentially subjected to deionization washing, water drying, core removal, freeze drying, and pulverization to 80 meshes to obtain the Chinese medicine complex C; Step 303. Put the traditional Chinese medicine complex C prepared in step 302, glacial acetic acid and anhydrous ethanol into an ultrasonic reactor, and react for 35 minutes under the conditions of an ice bath at 0°C-5°C and an ultrasonic frequency of 30kHz-35kHz to obtain a pre-extract C; Step 304. The pre-extract C prepared in step 303 is transferred to a high-speed centrifuge, and centrifuged for 10 min at 12000 rpm-15000 rpm in an ice bath at 0°C-5°C, and then the supernatant is taken, and then extracted with ethyl acetate in turn, and the ethyl acetate is removed by rotary evaporation to obtain the traditional Chinese medicine composite extract C.

7. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 1, characterized in that: In step 301, the composite salt is obtained by mixing sodium chloride, zinc chloride and sodium bicarbonate in a mass ratio of 5:0.5:

1.

8. A spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 1, characterized in that: The mass ratio of quinquefolius, yam, agrimony and coffee beans in the traditional Chinese medicine composite extract A is (3.3-4.6): (1.5): (2.2-3.2): (1.8-2.7); The mass ratio of hawthorn and roxburghii in the traditional Chinese medicine composite extract B is (2.5-3.2):4; The mass ratio of olive, orange and green plum in the traditional Chinese medicine composite extract C is (2.6-3.8): (3.5-4.2): (4.6-5.2).

9. The use of a spleen-strengthening and appetite-stimulating Chinese medicine composition according to any one of claims 1 to 8, characterized in that: The invention is used for preparing spleen-strengthening and appetite-stimulating drugs, and the spleen-strengthening and appetite-stimulating drugs are used for improving anorexia in children, improving appetite, promoting digestion, regulating intestinal flora, and repairing gastric mucosa.

10. The use of a spleen-strengthening and appetite-stimulating Chinese medicine composition according to claim 9, characterized in that: The spleen-strengthening and appetite-stimulating medicine comprises a pharmaceutically acceptable excipient and the spleen-strengthening and appetite-stimulating Chinese medicine composition according to any one of claims 1 to 8; The method for preparing the spleen-strengthening and appetite-stimulating drug comprises the following steps: mixing Chinese herbal extract A, Chinese herbal extract B, Chinese herbal extract C and pharmaceutically acceptable excipients, and preparing the spleen-strengthening and appetite-stimulating drug according to a target dosage form.

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