Preparation method of spleen-tonifying and stomach-nourishing granules

By improving the preparation method of Jianpi Yangwei granules, using water vapor distillation and ethanol extraction, combined with microcrystalline cellulose, the problem of incomplete extraction of active ingredients and difficult to grasp the dosage of young children is solved, and more efficient medicinal effects are achieved And convenient use experience.

CN119258181APending Publication Date: 2025-01-07HEBEI BAISHAN PHARM CO LTD
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Patent Information

Application Number
CN202411520651.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-29
Publication Date
2025-01-07

AI Technical Summary

Technical Problem

The effective ingredients of existing Jianpi Yangwei Granules are not completely extracted, especially for young children, it is difficult to accurately grasp the dosage when taking it, which affects the efficacy of the medicine.

Method used

A preparation method is adopted, including Amomum villossum, Tangerine peel, Magnolia officinalis, Green peel, Poria cocos, Atractylodes macrocephala, Licorice, Codonopsis pilosula, Poria cocos, yeast powder, amylase, starch and sweetener combination, and extracted by steam distillation and ethanol. Extract active ingredients by smearing and other steps, and add microcrystalline cellulose to reduce the viscosity of the paste, and make particles with a specification of 1.5g/bag.

Benefits of technology

Extract the effective ingredients of the components in the prescription to the greatest extent, improve the efficacy of the medicine, solve the problem of difficult dosage when taking it, and enhance the effect of the medicine and the convenience of taking it.

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Abstract

The invention provides a preparation method of spleen-tonifying and stomach-nourishing granules, which comprises the following steps: step 1, crushing fructus amomi into fine powder, and sieving for later use; step 2, adding water into the dried orange peel, extracting volatile oil by adopting a steam distillation method, separating the dried orange peel volatile oil from dried orange peel residues, drying the dried orange peel residues, adding ethanol which submerges the dried orange peel residues, standing, percolating in a percolation device, adding ethanol into the percolation device for soaking, collecting percolate, and concentrating the collected percolate under reduced pressure to obtain the dried orange peel extract. Adding pericarpium citri reticulatae volatile oil, and uniformly mixing to obtain pericarpium citri reticulatae clear paste; step 3, adding water into codonopsis pilosula, polyporus umbellatus, poria cocos and liquorice, decocting twice, filtering, combining decoction, and concentrating into first clear paste; step 4, performing reflux extraction on the officinal magnolia bark, the green tangerine peel and the largehead atractylodes rhizome through ethanol, recovering the ethanol until no ethanol smell exists, and performing vacuum concentration to obtain second clear paste; step five, adding starch into the dried orange peel clear paste, the first clear paste and the second clear paste, uniformly stirring to prepare large particles, and drying; and 6, adding yeast powder, amylase, fructus amomi powder and a sweetening agent into the dried product obtained in the step 5, crushing into fine powder, uniformly mixing, preparing into granules by using ethanol as a wetting agent, drying, and subpackaging into 1.5 g / bag. Effective components of the components in the prescription can be extracted to the greatest extent, so that the medicine effect is improved, and the problem that the dosage is difficult to accurately grasp when children take the medicine is solved.
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Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a method for preparing spleen-strengthening and stomach-nourishing granules. Background Art

[0002] Jianpi Yangwei Granules are included in the drug standard (WS3-B-3648-98) issued by the Ministry of Health. They are composed of 11 Chinese medicines, including Amomum villosum, Tangerine peel, Magnolia officinalis, Citrus aurantium, Polyporus, Atractylodes macrocephala, Licorice, Codonopsis pilosula, and Poria cocos. They have the functions of strengthening the spleen and digestion, stopping diarrhea and promoting diuresis. They are used for gastrointestinal weakness, indigestion, vomiting and diarrhea, abdominal distension and pain, urination difficulties, and sallow complexion and thin muscles. The elderly and young children are prone to symptoms of weak spleen and stomach, loss of appetite, and physical fatigue. Especially for young children, they will not think about food and will not be greedy when they see food, which will lead to weight loss, sweating, yellow complexion, and easy illness. Jianpi Yangwei Granules can be taken to strengthen the spleen and digestion and help improve the above symptoms.

[0003] However, due to the conditions at that time, the extraction of the effective ingredients of each component in the prescription was limited. In addition, the specification of Jianpi Yangwei Granules in this promulgated standard is 9g / bag, and adults can take one bag at a time, while children only need to take 1.5g at a time. This makes it difficult for children to control the dosage when taking it, which in turn affects the efficacy of the drug. Summary of the invention

[0004] In view of this, the present invention aims to provide a spleen-strengthening and stomach-nourishing granule to solve the problem of incomplete extraction of effective ingredients and lack of specifications suitable for young children to take.

[0005] To achieve the above object, the technical solution of the present invention is achieved as follows:

[0006] A method for preparing spleen-strengthening and stomach-nourishing granules, the spleen-strengthening and stomach-nourishing granules comprising the following components: 14 parts of Amomum villosum, 14 parts of dried orange peel, 28 parts of Magnolia officinalis, 14 parts of Citrus aurantium, 112 parts of Polyporus umbellatus, 112 parts of Atractylodes macrocephala, 56 parts of Licorice, 112 parts of Codonopsis pilosula, 112 parts of Poria cocos, 88 parts of yeast powder, 9 parts of amylase, 160 parts of starch and 300-330 parts of sweetener;

[0007] The preparation method of the spleen-strengthening and stomach-nourishing granules comprises the following steps:

[0008] Step 1: Grind Amomum villosum into fine powder, sieve and set aside;

[0009] Step 2, after adding water to the tangerine peel, adopt steam distillation to extract volatile oil, separate tangerine peel volatile oil and tangerine peel residue, after the tangerine peel residue is dried, add ethanol that does not cover the tangerine peel residue, put it into a percolation device for percolation after standing for 1-2 hours, add ethanol to the percolation device and soak for 18-20 hours, collect the percolation liquid, decompress and concentrate the collected percolation liquid to a relative density of 1.05-1.10, add tangerine peel volatile oil and mix to obtain tangerine peel clear paste;

[0010] Step 3, decocting Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice root twice with water, the first time for 2-3 hours and the second time for 1-1.5 hours, filtering and combining the decoctions, and concentrating to a first clear paste with a relative density of 1.06-1.10;

[0011] Step 4, extracting the three ingredients of Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala by reflux extraction with ethanol, recovering the ethanol until there is no alcohol taste, and concentrating under reduced pressure to a second clear paste with a relative density of 1.10 to 1.15;

[0012] Step 5, adding starch to the dried tangerine peel paste, the first paste and the second paste, stirring evenly to form large particles, and drying;

[0013] Step 6: Add yeast powder, amylase, amomum powder and sweetener to the dried product obtained in step 5, crush into fine powder, mix evenly, use ethanol as a wetting agent to make granules, dry and pack into bags with a specification of 1.5 g / bag.

[0014] Furthermore, in the step 2, after the tangerine peel is soaked in 5 to 6 times the amount of water for 2 to 3 hours, the volatile oil is extracted by steam distillation.

[0015] Furthermore, in the step 2, the concentration of ethanol is 50-60%, and the amount of ethanol added to the percolation device is 8-10 times the weight of the dried tangerine peel residue.

[0016] Furthermore, in the step three, when water is added for decoction twice, 8 to 10 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice is added for the first time, and 5 to 6 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice is added for the second time.

[0017] Furthermore, in the step 4, Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala are extracted by reflux with 60% ethanol.

[0018] Furthermore, in step five, microcrystalline cellulose is added.

[0019] Furthermore, the step five adopts the following operation: the tangerine peel paste and the second paste are mixed and stirred, half of the microcrystalline cellulose is added during the stirring process and continued to stir evenly, the first paste is stirred, the remaining microcrystalline cellulose is added during the stirring process, the two parts of the paste with the microcrystalline cellulose added are mixed, starch is added, and after stirring evenly, large particles are made, and then dried.

[0020] Furthermore, the total amount of the microcrystalline cellulose added is 0.4 to 0.5 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0021] Compared with the prior art, the preparation method of the spleen-strengthening and stomach-nourishing granules described in the present invention has the following advantages: it can extract the effective ingredients of the components in the prescription to the greatest extent, thereby improving the efficacy, and the drug specification is 1.5g / bag, which avoids the problem of difficulty in accurately grasping the dosage when young children take it, and is conducive to the convenience of taking. DETAILED DESCRIPTION

[0022] The present invention will be further described below in conjunction with specific embodiments. It should be noted that the data in the following experimental examples are obtained by the inventor through a large number of experiments. Due to space limitations, only a part of them is shown in the specification, and those of ordinary skill in the art can understand and implement the present invention under these data. These embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these changes or modifications also fall within the scope protected by the present application.

[0023] The spleen-strengthening and stomach-nourishing granules of the present invention comprise the following components: 14 parts of amomum villosum, 14 parts of dried tangerine peel, 28 parts of magnolia bark, 14 parts of green tangerine peel, 112 parts of umbellate, 112 parts of atractylodes macrocephala, 56 parts of liquorice, 112 parts of codonopsis pilosula, 112 parts of poria, 88 parts of yeast powder, 9 parts of amylase, 160 parts of starch and 300-330 parts of sweetener.

[0024] The preparation method of the spleen-strengthening and stomach-nourishing granules comprises the following steps:

[0025] Step 1: Grind Amomum villosum into fine powder, sieve and set aside;

[0026] Step 2, after adding water to the tangerine peel, adopt steam distillation to extract volatile oil, separate tangerine peel volatile oil and tangerine peel residue, after the tangerine peel residue is dried, add ethanol that does not cover the tangerine peel residue, put it into a percolation device for percolation after standing for 1-2 hours, add ethanol to the percolation device and soak for 18-20 hours, collect the percolation liquid, decompress and concentrate the collected percolation liquid to a relative density of 1.05-1.10, add tangerine peel volatile oil and mix to obtain tangerine peel clear paste;

[0027] Step 3, decocting Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice root twice with water, the first time for 2-3 hours and the second time for 1-1.5 hours, filtering and combining the decoctions, and concentrating to a first clear paste with a relative density of 1.06-1.10;

[0028] Step 4, extracting the three ingredients of Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala by reflux extraction with ethanol, recovering the ethanol until there is no alcohol taste, and concentrating under reduced pressure to a second clear paste with a relative density of 1.10 to 1.15;

[0029] Step 5, adding starch to the dried tangerine peel paste, the first paste and the second paste, stirring evenly to form large particles, and drying;

[0030] Step 6: Add yeast powder, amylase, amomum powder and sweetener to the dried product obtained in step 5, crush into fine powder, mix evenly, use ethanol as a wetting agent to make granules, dry and pack into bags with a specification of 1.5 g / bag.

[0031] Furthermore, in step 2, after the tangerine peel is soaked in 5 to 6 times the amount of water for 2 to 3 hours, the volatile oil is extracted by steam distillation.

[0032] Furthermore, in step 2, the concentration of ethanol is 50-60%, and the amount of ethanol added to the percolation device is 8-10 times the weight of the dried tangerine peel residue.

[0033] Furthermore, in step three, when adding water for decoction twice, add water 8 to 10 times the total amount of Codonopsis pilosula, Polyporus umbellatus, Poria cocos, and Licorice root for the first time, and add water 5 to 6 times the total amount of Codonopsis pilosula, Polyporus umbellatus, Poria cocos, and Licorice root for the second time.

[0034] Furthermore, in step 4, Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala are extracted by reflux with 60% ethanol.

[0035] Example 1

[0036] Crush 14g Amomum villosum into fine powder, sieve and set aside.

[0037] 14g of tangerine peel is added with 5 times the amount of water and soaked for 3h, and then volatile oil is extracted by steam distillation to separate tangerine peel volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 50% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 1h. 50% ethanol in an amount of 8 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 18h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05, and then tangerine peel volatile oil is added and mixed to obtain tangerine peel clear paste.

[0038] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 8 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 2h. For the second decoction, 5 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 1h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.06.

[0039] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.10.

[0040] 160g starch was added to the prepared dried orange peel paste, the first paste and the second paste, stirred evenly to form large granules, and dried. 88g yeast powder, 9g amylase, Amomum villosum powder and 330g granulated sugar were added, crushed into fine powder, mixed evenly, and granulated with ethanol as a wetting agent. After drying, 750g granules were obtained, which were packaged in a bag with a specification of 1.5g per bag.

[0041] Example 2

[0042] Grind 14g of Amomum villosum into fine powder, sieve and set aside.

[0043] 14g of dried tangerine peel is added with 6 times the amount of water and soaked for 2h, and then volatile oil is extracted by steam distillation to separate the volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 50% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 1h. 50% ethanol in an amount of 8 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 20h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05, and then the volatile oil of the tangerine peel is added and mixed to obtain the tangerine peel paste.

[0044] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 8 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 2h. For the second decoction, 5 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 1h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.06.

[0045] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.10.

[0046] 160g starch was added to the prepared dried orange peel paste, the first paste and the second paste, stirred evenly to form large granules, and dried. 88g yeast powder, 9g amylase, Amomum villosum powder and 330g granulated sugar were added, crushed into fine powder, mixed evenly, and granulated with ethanol as a wetting agent. After drying, 750g granules were obtained, which were packaged in a bag with a specification of 1.5g per bag.

[0047] Comparative Example 1

[0048] The preparation method of Jianpi Yangwei Granules in the 19th volume of the National Drug Standard Chinese Medicine Formula Preparation is adopted, specifically, 14g of Amomum villosum is crushed into fine powder, sieved and set aside. 14g of tangerine peel is steam distilled to extract volatile oil, dissolved with appropriate amount of ethanol and set aside. Take 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos, 556g of Licorice and tangerine peel residue, add water and decoct twice, the first time for 2 hours, the second time for 1 hour, filter, combine the decoction, and concentrate to a relative density of 1.06 (98°C). 28g of Magnolia officinalis, 14g of Citrus aurantium, and 112g of Atractylodes macrocephala are extracted with 60% ethanol reflux, and the ethanol is recovered until there is no alcohol taste. Concentrate the water and alcohol paste to a relative density of 1.28-1.30 (98°C), cool it, add 160g starch, stir well to make large granules, dry it, add 88g yeast powder, 9g amylase, Amomum villosum powder, 330g sugar, crush it into fine powder, mix well, make granules with appropriate amount of ethanol, dry it. Add tangerine peel oil alcohol solution and appropriate amount of flavor, seal it, make 750g granules, and you have it. The specification of each bag is 9g.

[0049] Hesperidin in tangerine peel and green peel is used as the index component for content determination, and high performance liquid chromatography is used for detection. The specific detection method can refer to the existing technology. The relevant data are shown in Table 1. The hesperidin content in the prescription raw materials in Table 1 refers to the hesperidin content detected in tangerine peel and green peel when the tangerine peel and green peel used in the prescription are not subjected to the extraction process, and when converted to each bag of finished products. For example, the prescription dosage of tangerine peel and green peel in Comparative Example 1 is 14g, and the amount of tangerine peel and green peel added to each bag of finished products after conversion is 168mg, and the hesperidin content of tangerine peel and green peel used in the prescription is 5.2% and 6.9% respectively.

[0050] Table 1

[0051]

[0052]

[0053] As shown in Table 1, Examples 1 and 2 using the preparation method of the present invention have better hesperidin transfer rates than Comparative Example 1. In the treatment of tangerine peel in Comparative Example 1, the tangerine peel residue separated after extracting volatile oil by steam distillation is directly decocted with water, and tangerine peel oil alcohol is added last in the granulation process, which easily leads to insufficient extraction of tangerine peel effective components and easy loss of tangerine peel volatile oil. Examples 1 and 2 improve the extraction steps and addition sequence of tangerine peel. The tangerine peel residue separated is mixed with tangerine peel volatile oil after percolation extraction, and is blended with extracts of other components before adding yeast powder, amylase, amomum powder and sweetener, which not only reduces the loss of volatile oil, but also can extract the effective components of tangerine peel to the greatest extent, effectively increasing the content of hesperidin to improve the effect of the drug.

[0054] The inventor found that in step 5, the tangerine peel paste, the first paste and the second paste were mixed and dried, because the paste was sticky and easy to boil, which would cause the loss of effective ingredients. Therefore, the inventor continued to improve step 5. The inventor conducted a large number of experiments and found that adding microcrystalline cellulose can reduce the viscosity of the paste. Specifically, step 5 includes the following steps:

[0055] Mix the tangerine peel paste and the second paste, add half of the microcrystalline cellulose during the stirring process and continue to stir evenly, stir the first paste, add the remaining microcrystalline cellulose during the stirring process, mix the two parts, add starch, stir evenly to make large particles, and dry.

[0056] Furthermore, the total amount of the microcrystalline cellulose added is 0.4 to 0.5 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0057] Example 3

[0058] Grind 14g of Amomum villosum into fine powder, sieve and set aside.

[0059] 14g of dried tangerine peel is added with 6 times the amount of water and soaked for 2h, and then volatile oil is extracted by steam distillation to separate the volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 50% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 1h. 50% ethanol in an amount of 8 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 20h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05, and then the volatile oil of the tangerine peel is added and mixed to obtain the tangerine peel paste.

[0060] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 8 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 2h. For the second decoction, 5 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 1h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.06.

[0061] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.10.

[0062] Weigh microcrystalline cellulose, the amount of which is 0.4 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0063] The dried orange peel paste and the second paste were mixed and stirred, half of the microcrystalline cellulose was added during the stirring process and continued to stir evenly, the first paste was stirred, the remaining microcrystalline cellulose was added during the stirring process, the two parts were mixed, 160g of starch was added, and large particles were made after stirring evenly, and then dried. 88g of yeast powder, 9g of amylase, amomum powder and 330g of granulated sugar were added, crushed into fine powder, mixed evenly, ethanol was used as a wetting agent to make particles, dried, and packaged, with a specification of 1.5g per bag.

[0064] Example 4

[0065] Grind 14g of Amomum villosum into fine powder, sieve and set aside.

[0066] 14g of dried tangerine peel is added with 6 times the amount of water and soaked for 3h, and then volatile oil is extracted by steam distillation to separate the volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 50% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 2h. 50% ethanol in an amount of 10 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 20h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05, and then the volatile oil of the tangerine peel is added and mixed to obtain the tangerine peel paste.

[0067] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 10 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice was added and decocted for 3h. For the second decoction, 5 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice was added and decocted for 1.5h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.06.

[0068] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.15.

[0069] Weigh microcrystalline cellulose, the amount of which is 0.5 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0070] The dried orange peel paste and the second paste were mixed and stirred, half of the microcrystalline cellulose was added during the stirring process and continued to stir evenly, the first paste was stirred, the remaining microcrystalline cellulose was added during the stirring process, the two parts were mixed, 160g of starch was added, and large particles were made after stirring evenly, and dried. 88g of yeast powder, 9g of amylase, amomum powder and 330g of sucrose powder were added, crushed into fine powder, mixed evenly, ethanol was used as a wetting agent to make particles, dried, and packaged, with a specification of 1.5g per bag.

[0071] Comparative Example 2

[0072] Grind 14g of Amomum villosum into fine powder, sieve and set aside.

[0073] 14g of dried tangerine peel is soaked in 6 times the amount of water for 2h, and then volatile oil is extracted by steam distillation to separate the volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 50% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 1h. 50% ethanol in an amount of 8 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 20h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05, and then volatile oil is added and mixed to obtain a tangerine peel paste.

[0074] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 8 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 2h. For the second decoction, 5 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 1h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.06.

[0075] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.10.

[0076] Weigh microcrystalline cellulose, the amount of which is 0.4 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0077] Mix the dried orange peel paste, the first paste and the second paste, add microcrystalline cellulose during the stirring process and continue to stir evenly, add 160g starch, stir evenly to make large particles, and dry. Add 88g yeast powder, 9g amylase, amomum powder and 330g sweetener, crush into fine powder, mix evenly, use ethanol as a wetting agent to make particles, dry and package, the specification of each bag is 1.5g.

[0078] In order to save space, only magnolol and honokiol in Magnolia officinalis are used as examples for detailed description in this application. For specific determination methods, please refer to Zhao Hongzhi, Ye Tingxiang, Liu Zhenghui, et al. Study on Quality Standard of Jianpi Yangwei Granules [J]. Medical Herald, 2008. DOI: CNKI: SUN: YYDB.0.2008-07-045. The determination results are shown in Table 2.

[0079] Table 2

[0080] serial number Magnolia content (mg / g) Honokiol content (mg / g) Example 1 0.2700 0.1775 Example 2 0.2731 0.1709 Example 3 0.3521 0.2518 Example 4 0.3611 0.2332 Comparative Example 1 0.2733 0.1756 Comparative Example 2 0.2956 0.1901

[0081] As shown in Table 2, Example 3 and Example 4 add microcrystalline cellulose, and the addition of microcrystalline cellulose is conducive to making the structure of the clear paste loose, and can reduce the bumping of the paste during the drying process, and the content of magnolol and magnolol after the increase is conducive to the extraction of the effective ingredients of the components in the prescription. Although microcrystalline cellulose is also added in Comparative Example 2, the increase of magnolol and magnolol content is limited. It is speculated that the possible reason is that microcrystalline cellulose is added together with tangerine peel clear paste, the first clear paste and the second clear paste, and under stirring, microcrystalline cellulose is more likely to wrap the first clear paste containing a small amount of moisture, and less participation and tangerine peel clear paste, the effect of the second clear paste, the tangerine peel clear paste and the second clear paste have little effect on reducing viscosity, and are also not conducive to forming a loose structure. Embodiment 3 and Example 4 add microcrystalline cellulose separately, a part is mixed with tangerine peel clear paste, the second clear paste and embedded therein, reduce viscosity, improve looseness, another part is mixed with the first clear paste and plays a role, which is conducive to better play the effect of microcrystalline cellulose reducing the viscosity of the paste.

[0082] Considering that the spleen-strengthening and stomach-nourishing granules of the present invention will be used for children, excessive intake of sweeteners is not good for the health of children and is not good for nourishing the stomach. The present application further reduces the amount of sweeteners used and improves the way of adding sweeteners to ensure that the user still has compliance when the sweeteners are reduced. Specifically, the prescription composition includes 14 parts of Amomum villosum, 14 parts of dried tangerine peel, 28 parts of Magnolia officinalis, 14 parts of Citrus aurantium, 112 parts of Polyporus, 112 parts of Atractylodes macrocephala, 56 parts of Licorice, 112 parts of Codonopsis pilosula, 112 parts of Poria, 88 parts of yeast powder, 9 parts of amylase, 160 parts of starch and 120 to 140 parts of sweetener.

[0083] The relevant preparation method adopts the following steps:

[0084] Step 1: Grind Amomum villosum into fine powder, sieve and set aside;

[0085] Step 2: After the tangerine peel is soaked in 5 to 6 times the amount of water for 2 to 3 hours, volatile oil is extracted by steam distillation, and volatile oil and tangerine peel residue are separated. After the tangerine peel residue is dried, ethanol that does not cover the tangerine peel residue is added, and the tangerine peel residue is placed in a percolation device for percolation after standing for 1 to 2 hours. Ethanol is added to the percolation device and soaked for 18 to 20 hours, and the percolation liquid is collected. The collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05 to 1.10, and volatile oil of tangerine peel is added and mixed to obtain tangerine peel paste;

[0086] Step 3, decocting Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice root twice with water, the first time for 2-3 hours and the second time for 1-1.5 hours, filtering and combining the decoctions, and concentrating to a first clear paste with a relative density of 1.06-1.10;

[0087] Step 4, extracting the three ingredients of Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala by reflux extraction with ethanol, recovering the ethanol until there is no alcohol taste, and concentrating under reduced pressure to a second clear paste with a relative density of 1.10 to 1.15;

[0088] Step 5, mixing and stirring the dried tangerine peel paste and the second paste, adding half of the microcrystalline cellulose during the stirring process and continuing to stir evenly, continuing to stir the first paste, adding the remaining microcrystalline cellulose during the stirring process, and mixing the two parts to obtain a mixture; sending the starch and the sweetener into the puffing machine, adding water for puffing, drying after the puffing is completed, mixing and stirring the mixture to form large particles, and drying.

[0089] Step six, adding yeast powder, amylase and Amomum villosum powder to the dried product obtained in step five, crushing into fine powder, mixing evenly, using ethanol as a wetting agent to form granules, and drying to obtain the product.

[0090] In step 5, the ratio of starch to water is 10:3-5. The puffing process can refer to the prior art.

[0091] Example 5

[0092] Grind 14g of Amomum villosum into fine powder, sieve and set aside.

[0093] 14g of dried tangerine peel is added with 6 times the amount of water and soaked for 2h, and then volatile oil is extracted by steam distillation to separate the volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 50% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 1h. 50% ethanol in an amount of 8 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 20h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.05, and then the volatile oil of the tangerine peel is added and mixed to obtain the tangerine peel paste.

[0094] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 8 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 2h. For the second decoction, 5 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice were added and decocted for 1h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.06.

[0095] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.10.

[0096] Weigh microcrystalline cellulose, the amount of which is 0.4 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0097] Mix the tangerine peel paste and the second paste, add half of the microcrystalline cellulose during the stirring process and continue to stir evenly, stir the first paste, add the remaining microcrystalline cellulose during the stirring process, and mix the two parts to obtain a mixture.

[0098] 160g of starch and 120g of sugar were fed into an extruder, and 80g of water was added for extrusion at a temperature of 120°C. After the extrusion, the powder was dried, mixed with the clear paste mixture to form large particles, and dried.

[0099] Add 88g yeast powder, 9g amylase and Amomum villosum powder to the dried material, grind into fine powder, mix well, use ethanol as a wetting agent to make granules, dry and package, the specification of each bag is 1.5g.

[0100] Example 6

[0101] Grind 14g of Amomum villosum into fine powder, sieve and set aside.

[0102] 14g of dried tangerine peel is added with 6 times the amount of water and soaked for 3h, and then volatile oil is extracted by steam distillation to separate the volatile oil and tangerine peel residue. After the tangerine peel residue is dried, 60% ethanol is added to cover the tangerine peel residue, and the mixture is placed in a percolation device for percolation after standing for 2h. 60% ethanol in an amount of 10 times the weight of the dried tangerine peel residue is added to the percolation device, and the mixture is soaked for 18h. The percolation liquid is collected, and the collected percolation liquid is concentrated under reduced pressure to a relative density of 1.10, and then the volatile oil of the tangerine peel is added and mixed to obtain the tangerine peel paste.

[0103] 112g of Codonopsis pilosula, 112g of Polyporus umbellatus, 112g of Poria cocos and 56g of Licorice were decocted twice with water. For the first decoction, 10 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice was added and decocted for 3h. For the second decoction, 6 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice was added and decocted for 1.5h. The decoctions were combined after filtration and concentrated to the first clear paste with a relative density of 1.10.

[0104] 28g of Magnolia officinalis, 14g of Citrus aurantium and 112g of Atractylodes macrocephala were extracted by reflux with 60% ethanol, the ethanol was recovered until there was no alcohol taste, and the extract was concentrated under reduced pressure to a second clear paste with a relative density of 1.15.

[0105] Weigh microcrystalline cellulose, the amount of which is 0.5 times the total amount of the tangerine peel paste, the first paste and the second paste.

[0106] Mix the tangerine peel paste and the second paste, add half of the microcrystalline cellulose during the stirring process and continue to stir evenly, stir the first paste, add the remaining microcrystalline cellulose during the stirring process, and mix the two parts to obtain a mixture.

[0107] 160g of starch and 140g of sugar were fed into an extruder, and 53g of water was added for extrusion at a temperature of 140°C. After the extrusion, the powder was dried, mixed with the clear paste mixture to form large particles, and dried.

[0108] Add 88g yeast powder, 9g amylase and Amomum villosum powder to the dried material, grind into fine powder, mix well, use ethanol as a wetting agent to make granules, dry and package, the specification of each bag is 1.5g.

[0109] Comparative Example 3

[0110] The prescription dosage and preparation method of Comparative Example 3 are the same as those of Example 3, except that the added amount of granulated sugar is 140 g.

[0111] 100 subjects were recruited, and each subject took the same amount of Jianpi Yangwei granules and the same amount of water to brew the solution, and conducted a taste test, and scored with numbers 1 to 5. Among them, 1 = poor taste, 2 = slightly poor taste, 3 = acceptable taste; 4 = satisfactory taste; 5 = very satisfactory taste. The average of each score value was taken, and the final taste test results are shown in Table 3. In order to improve the accuracy of the taste test and the accuracy of expression, the subjects were middle-aged and elderly people.

[0112] Table 3

[0113] serial number Taste Taste score Example 3 Soft sweet taste, slightly bitter 4 Example 4 Soft sweet taste, slightly bitter 4 Example 5 Soft sweet taste, slightly bitter 4 Example 6 Soft sweet taste, slightly bitter 4 Comparative Example 1 Soft sweet taste, slightly bitter 4 Comparative Example 2 Soft sweet taste, slightly bitter 4 Comparative Example 3 Slightly less sweet, more bitter 2

[0114] In Examples 5 and 6, starch and sweeteners are puffed, with starch as the skeleton. After puffing, the sweeteners are distributed and filled on the starch. After mixing with other drug ingredients, the sweeteners can be evenly dispersed in the drug, which is conducive to masking the bitterness with a small amount of sweeteners, improving the taste and compliance of taking. Compared with the large doses of sweeteners used in Examples 3-4 and Comparative Examples 1-2, the taste of Examples 5-6 can obtain a similar taste. However, due to the reduction in the amount of sweeteners, it is more suitable for young children to take. In Comparative Example 3, a small amount of sweeteners is added directly without treatment, and the bitterness is obvious, and the taste score is also low.

[0115] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for preparing spleen-strengthening and stomach-nourishing granules, the spleen-strengthening and stomach-nourishing granules comprising the following components: 14 parts of Amomum villosum, 14 parts of dried orange peel, 28 parts of Magnolia officinalis, 14 parts of Citrus aurantium, 112 parts of Polyporus umbellatus, 112 parts of Atractylodes macrocephala, 56 parts of Licorice, 112 parts of Codonopsis pilosula, 112 parts of Poria cocos, 88 parts of yeast powder, 9 parts of amylase, 160 parts of starch and 300-330 parts of sweetener; characterized in that, The preparation method of the spleen-strengthening and stomach-nourishing granules comprises the following steps: Step 1: Grind Amomum villosum into fine powder, sieve and set aside; Step 2, after adding water to the tangerine peel, adopt steam distillation to extract volatile oil, separate tangerine peel volatile oil and tangerine peel residue, after the tangerine peel residue is dried, add ethanol that does not cover the tangerine peel residue, put it into a percolation device for percolation after standing for 1-2 hours, add ethanol to the percolation device and soak for 18-20 hours, collect the percolation liquid, decompress and concentrate the collected percolation liquid to a relative density of 1.05-1.10, add tangerine peel volatile oil and mix to obtain tangerine peel clear paste; Step 3, decocting Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice root twice with water, the first time for 2-3 hours and the second time for 1-1.5 hours, filtering and combining the decoctions, and concentrating to a first clear paste with a relative density of 1.06-1.10; Step 4, extracting the three ingredients of Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala by reflux extraction with ethanol, recovering the ethanol until there is no alcohol taste, and concentrating under reduced pressure to a second clear paste with a relative density of 1.10 to 1.15; Step 5, adding starch to the dried tangerine peel paste, the first paste and the second paste, stirring evenly to form large particles, and drying; Step 6: Add yeast powder, amylase, amomum powder and sweetener to the dried product obtained in step 5, crush into fine powder, mix evenly, use ethanol as a wetting agent to make granules, dry and pack into bags with a specification of 1.5 g / bag.

2. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 1, characterized in that: In the step 2, after the tangerine peel is soaked in 5 to 6 times the amount of water for 2 to 3 hours, the volatile oil is extracted by steam distillation.

3. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 1, characterized in that: In the step 2, the concentration of ethanol is 50-60%, and the amount of ethanol added to the percolation device is 8-10 times the weight of the dried tangerine peel residue.

4. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 1, characterized in that: In the step 3, when water is added for decoction twice, 8 to 10 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice root is added for the first time, and 5 to 6 times the total amount of water of Codonopsis pilosula, Polyporus umbellatus, Poria cocos and Licorice root is added for the second time.

5. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 1, characterized in that: In the step 4, Magnolia officinalis, Citrus aurantium and Atractylodes macrocephala are extracted by reflux with 60% ethanol.

6. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 1, characterized in that: In the step five, microcrystalline cellulose is added.

7. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 5, characterized in that: The step five adopts the following operation: stir the tangerine peel paste and the second paste, add half of the microcrystalline cellulose during the stirring process and continue to stir evenly, stir the first paste, add the remaining microcrystalline cellulose during the stirring process, mix the two parts of the paste with the microcrystalline cellulose added, add starch, stir evenly to form large particles, and dry.

8. The method for preparing the spleen-strengthening and stomach-nourishing granules according to claim 5, characterized in that: The total amount of the microcrystalline cellulose added is 0.4 to 0.5 times the total amount of the tangerine peel paste, the first paste and the second paste.

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