CN1579523A - Infant's Runtu granulars and preparation method - Google Patents

Infant's Runtu granulars and preparation method Download PDF

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Publication number
CN1579523A
CN1579523A CN 200410042525 CN200410042525A CN1579523A CN 1579523 A CN1579523 A CN 1579523A CN 200410042525 CN200410042525 CN 200410042525 CN 200410042525 A CN200410042525 A CN 200410042525A CN 1579523 A CN1579523 A CN 1579523A
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parts
volatile oil
powder
fry
stir
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CN1292789C (en
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张惠云
乔明琦
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QINGDAO SUNSHINE HAICHUAN MEDICAL TECHNOLOGY DEVELOPMENT CO LTD
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Abstract

The invention discloses a children runtu particles prescription and its manufacturing method. The particle is made up of ingredients with following proportion: ginseng 250-320, lagehead atractylodes 160-220, Tuckahoe 160-220, dried tangerine peel 200-270, nutagrass flatsedge rhizome 200-270, malt 200-270, hawthorn 200-270, amomum fruit 200-270, liquorice 100-180. the lagehead atractylodes, lagehead atractylodes, nutagrass flatsedge rhizome and amonum fruit are crashed into raw powder, extracts the volatile oil with steam distilling method. The dredge is blended with Tuckahoe, malt, hawthorn, liquorice and they are stewed, filtered, the filtered liquid is merged with water liquid after the oil is extracted, then they are condensed into plaster. The ginseng is crashed into raw powder, then adds in alcohol to carry on secondary extraction, combines the extracted liquids, filters and reclaims alcohol, and then they are condensed into plaster. It is combined with Tuckahoe, then they are dried, and crashed into dry extract plaster powder. The volatile oil is packaged with beta-cyclodextrin, low temperature dried, crashed, and blended with extractive plaster powder. The product can be acquired through adding in some cane sugar powder.

Description

Intercalation soil particle of children's and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine preparation prescription and preparation method thereof, intercalation soil particle prescription of particularly a kind of children's and preparation method thereof.
Background technology
Infantile gastritis is meant because physical property, chemical and biological injurious factor act on human body, causes a kind of disease that gastric mucosa is inflamed and sexually revises.Clinically be divided into acute and chronic two kinds, mainly be meant chronic infantile gastritis here.The cause of disease and pathogeny are not clear fully as yet, may be relevant with following factor: stressors, drug induced gastritis, albumen allergy, infection etc.Clinical manifestation based on stomachache, abdominal distention, belch, inappetence, nausea and vomiting, unable, become thin etc.Pathological change is based on the infringement of gastric mucosa shallow, and the treatment aspect does not have specific treatment, mainly is anti symptom treatment, as gives mucosa protective agent, histamine H 2 receptor's blocker, anti-helicobacter pylori medicine etc.
The research of Chinese medicine bound pair infantile gastritis report is less over past ten years, may be because of the restriction of subject, and make the disease that internal medicine and other clinical specialities are compared in its research want much less.And the overwhelming majority all is the research at treatment side's medicine.Still based on coloclysis and oral decoction, this causes inconvenience to the patient to children's's clinical application.Though occurred granule, tablet and capsule in the report in recent years, for number is still few, and be former powder formulation, dose is big, and bioavailability is low.If extract effective ingredient or effective site in compound recipe or the medicine, or be that raw material then can significantly reduce dose with the extract powder.Consider these aspects, preparation research and improvement become one of primary study direction of infantile gastritis.
This prescription be national distinguished veteran doctors of TCM Mr. Zhang Zhenyu learn something in history the people method, melt treatment children's chronic gastritis that self reason foundes through proved recipe.This side utilize natural drug abnormal smells from the patient, return through characteristics such as, lifting sink-floats, transfer the mediation ability of human body self, the inherent more pathogenesis system of exciting human, remedying defects and rectifying errors is not controlled inflammation and scorching spontaneous recovery on the whole.And the characteristics that this product is tender and lovely at children's's internal organs, shape gas does not fill, strengthening vital QI to eliminate pathogenic factors all adopt gentle product, and are eliminating evil and just do not hinder, and set upright and do not stay heresy.As the potent activating QI to eliminate phlegm medicines such as summer, the Radix Aucklandiae that reduce by half among the former side, and add with gentle medicines of regulating the flow of vital energy such as Rhizoma Cyperi, Fructus Citris.But up to now, also only rest on the clinical treatment of prescription, do not see that the Chinese patent medicine preparation that this prescription is arranged comes out.
The present invention makes a kind of Chinese patent medicine preparation on the basis of above-mentioned prescription, be that the intercalation soil particle of children's of main effective ingredient has invigorating the spleen and regulating the stomach with Radix Ginseng, and removing dampness disappears stagnant, promoting the circulation of QI to relieve pain.Be used for infantile gastritis, because of intemperance of taking food, syndrome of incoordination between spleen and stomach due to the taste abnormal ascending-descending of QI.Card is seen stomachache, feels sick, and pantothenic acid, abdominal distention, indigestion and loss of appetite, fatigue and weakness, light red tongue, greasy fur, arteries and veins or slow.The intercalation soil particle treatment of children's has obtained obvious effects, and the prescription of this medicament and preparation technology can produce bigger influence to the quality and the curative effect of medicine.
Summary of the invention
The object of the present invention is to provide the intercalation soil particle of a kind of children's, the intercalation native preparation of children's is made graininess, be used to take after mixing it with water.Its effective ingredient can reach at utmost and keep.
The present invention also aims to provide a kind of preparation method of above-mentioned granular preparation.
The prescription of the intercalation soil particle of children's of the present invention is: Radix Ginseng, the Rhizoma Atractylodis Macrocephalae (stir-fry), Poria, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Fructus Hordei Germinatus (stir-fry), Fructus Crataegi (Jiao), Fructus Amomi, Radix Glycyrrhizae.
Specifically each the tcm components processing and preparing by the following weight ratio forms:
250~320 parts of Radix Ginsengs
160~220 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry)
160~220 parts in Poria
200~270 parts of Pericarpium Citri Reticulataes
200~270 parts of Rhizoma Cyperis
200~270 parts in Fructus Hordei Germinatus (stir-fry)
200~270 parts of Fructus Crataegis (Jiao)
200~270 parts of Fructus Amomis
100~180 parts in Radix Glycyrrhizae
In the above-mentioned Chinese medicine of respectively distinguishing the flavor of, best formula combination is:
285 parts of Radix Ginsengs
190 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry)
190 parts in Poria
238 parts of Pericarpium Citri Reticulataes
238 parts of Rhizoma Cyperis
238 parts in Fructus Hordei Germinatus (stir-fry)
238 parts of Fructus Crataegis (Jiao)
238 parts of Fructus Amomis
143 parts in Radix Glycyrrhizae
The preparation method of the intercalation soil particle of above-mentioned children's of the present invention may further comprise the steps:
A: the Rhizoma Atractylodis Macrocephalae (stir-fry), Pericarpium Citri Reticulatae, Rhizoma Cyperi, amomum powder are broken into coarse powder, add the water of 5 times of weight, and steam distillation extracted volatile oil 5 hours, collect volatile oil, and distillation rear solution device is in addition collected;
Medicinal residues and Poria, Fructus Hordei Germinatus (stir-fry), Fructus Crataegi (Jiao), Radix Glycyrrhizae that b: step a extracts behind the volatile oil decoct with water secondary, add for the first time 10 times of water gagings, decocted 2 hours, the water that adds for the second time 6 times of amounts, decocted 1 hour, and merged decoction liquor, filter, the aqueous solution that filtrate and step a extract behind the volatile oil merges, and is condensed into the clear paste that relative density is 1.35-1.38 at 55 ℃;
C: the Radix Ginseng powder is broken into coarse powder, adds 50% alcohol heating reflux and extracts secondary, adds 8 times of amounts for the first time, add for the second time 6 times of amounts, the each extraction 2 hours, merge extractive liquid, filters, filtrate recycling ethanol, be condensed into the clear paste that relative density is 1.35-1.38 at 55 ℃, extract clear paste with the step a Rhizoma Atractylodis Macrocephalae, Poria etc. and merge mixing, drying is ground into dry extract;
D: get 5 times of step a volatilization oil mass cycloheptaamyloses, add 20% ethanol of 2 times of dextrin amounts, grind to form pasty state, add above-mentioned volatile oil, ground 2 hours, cold drying is pulverized;
E: combining step c obtains the volatile oil encapsulation object dry powder that extract powder and steps d obtain, and fully mixes, and the mixture that adds dextrin and sugar obtains this product as the adjuvant dry granulation.
Wherein, the ratio of sugar and dextrin is 1: 1 in the adjuvant that uses among the step e, and supplementary product consumption is about drug extract powder and volatile oil encapsulation object total amount 1 times.
By the intercalation soil particle of the children's of method for preparing, made full use of the characteristic of the effective ingredient of the medical material of respectively distinguishing the flavor of, taked different extractions and processing method, kept content of effective to greatest extent.With the peoniflorin is index, adopt the HPLC method to measure the amount of the Radix Paeoniae Alba in this preparation, the result shows the amount that can accurately determine the peoniflorin in the preparation with this method mensuration, determine at last to contain the amount of the Radix Paeoniae Alba in peoniflorin in this preparation, the intercalation soil particle specification of children's is every bag of 7g, and this product contains Radix Ginseng with ginsenoside Rg1 (C for every bag 42H 72O 14) and ginsenoside Re (C 48H 82O 18) meter, be no less than 2.7mg.
The specific embodiment
Embodiment 1:
The Rhizoma Atractylodis Macrocephalae (stir-fry) 160g, Pericarpium Citri Reticulatae 200g, Rhizoma Cyperi 200g, Fructus Amomi 200g are ground into coarse powder, add 3600 ml waters, and steam distillation extracted volatile oil 5 hours, collect about 8 milliliters of volatile oil, and distillation rear solution device is in addition collected.
Medicinal residues and Poria 160g, Fructus Hordei Germinatus (stir-fry) 200g, Fructus Crataegi (Jiao) 200g, Radix Glycyrrhizae 100g behind the extraction volatile oil decoct with water secondary, add for the first time 14200 ml waters, decocted 2 hours, add for the second time 8520 milliliters water, decocted 1 hour, and merged decoction liquor, filter, aqueous solution behind filtrate and the extraction volatile oil merges, and 55 ℃ are condensed into the clear paste that relative density is 1.35-1.38.
Radix Ginseng 250g is ground into coarse powder, adds 50% alcohol heating reflux and extracts secondary, adds 2000 milliliters for the first time, for the second time add 1500 milliliters, the each extraction 2 hours, merge extractive liquid, filters, filtrate recycling ethanol, 55 ℃ are condensed into the clear paste that relative density is 1.35-1.38, extract clear paste with the Rhizoma Atractylodis Macrocephalae, Poria etc. and merge mixing, drying is ground into the about 360g of dry extract.
Get the 40g cycloheptaamylose, add 80 milliliter of 20% ethanol, grind to form pasty state, add above-mentioned volatile oil, ground 2 hours, cold drying is pulverized, and gets the about 46g of encapsulation object.
Above dry extract of combining step and volatile oil encapsulation object dry powder is 406g altogether, fully mixes, and adds the about 594g of mixture (1: 1) of dextrin and sugar, and dry granulation gets granule 1000g, obtains this product.
Embodiment 2:
The Rhizoma Atractylodis Macrocephalae (stir-fry) 220g, Pericarpium Citri Reticulatae 27g, Rhizoma Cyperi 270g, Fructus Amomi 270g are ground into coarse powder, add 4900 ml waters, and steam distillation extracted volatile oil 5 hours, collect about 10.8 milliliters of volatile oil, and distillation rear solution device is in addition collected.
Medicinal residues and Poria 220g, Fructus Hordei Germinatus (stir-fry) 270g, Fructus Crataegi (Jiao) 270g, Radix Glycyrrhizae 180g behind the extraction volatile oil decoct with water secondary, add for the first time 19700 ml waters, decocted 2 hours, add for the second time 11820 ml waters, decocted 1 hour, and merged decoction liquor, filter, aqueous solution behind filtrate and the extraction volatile oil merges, and being condensed into relative density is the clear paste of 1.35-1.38 (55 ℃).
Radix Ginseng 32g is ground into coarse powder, adds 50% alcohol heating reflux and extracts secondary, adds 2560 milliliters for the first time, for the second time add 1920 milliliters, the each extraction 2 hours, merge extractive liquid, filters, filtrate recycling ethanol, being condensed into relative density is the clear paste of 1.35-1.38 (55 ℃), extracts clear paste with the Rhizoma Atractylodis Macrocephalae, Poria etc. and merges mixing, drying is ground into the about 493g of dry extract.
Get the 54g cycloheptaamylose, add 108 milliliter of 20% ethanol, grind to form pasty state, add above-mentioned volatile oil, ground 2 hours, cold drying, pulverize encapsulation object 62g.
Above dry extract of combining step and volatile oil encapsulation object dry powder is 555g altogether, fully mixes, and the mixture 445g (1: 1) that adds dextrin and sugar makes granule 1000g as the adjuvant dry method, obtains this product.
Embodiment 3:
The Rhizoma Atractylodis Macrocephalae (stir-fry) 190g, Pericarpium Citri Reticulatae 238g, Rhizoma Cyperi 238g, Fructus Amomi 238g are ground into coarse powder, add 4520 ml waters, and steam distillation extracted volatile oil 5 hours, collect about 9.5 milliliters of volatile oil, and distillation rear solution device is in addition collected.
Medicinal residues and Poria 190g, Fructus Hordei Germinatus (stir-fry) 238g, Fructus Crataegi (Jiao) 238g, Radix Glycyrrhizae 143g behind the extraction volatile oil decoct with water secondary, add for the first time 17130 ml waters, decocted 2 hours, add for the second time 10278 ml waters, decocted 1 hour, and merged decoction liquor, filter, aqueous solution behind filtrate and the extraction volatile oil merges, and being condensed into relative density is the clear paste of 1.35-1.38 (55 ℃).
Radix Ginseng 285g is ground into coarse powder, adds 50% alcohol heating reflux and extracts secondary, adds 2280 milliliters for the first time, for the second time add 1710 milliliters, the each extraction 2 hours, merge extractive liquid, filters, filtrate recycling ethanol, being condensed into relative density is the clear paste of 1.35-1.38 (55 ℃), extracts clear paste with the Rhizoma Atractylodis Macrocephalae, Poria etc. and merges mixing, drying is ground into dry extract 430g.
Get the 47.5g cycloheptaamylose, add 95 milliliter of 20% ethanol, grind to form pasty state, add above-mentioned volatile oil, ground 2 hours, cold drying, pulverize encapsulation object 54.5g.
Above dry extract of combining step and volatile oil encapsulation object dry powder is 484.5g altogether, fully mixes, and the mixture 515.5g (1: 1) that adds dextrin and sugar makes granule 1000g as the adjuvant dry method, obtains this product.
The invention described above obtains the intercalation soil particle of children's except reaching the general prescription of granule.Also active constituent content is measured research: be index with ginsenoside, adopt the HPLC method to measure the amount of Radix Ginseng in this preparation, the result shows the amount that can accurately determine the ginsenoside in the preparation with this method mensuration, determine at last to contain the amount of Radix Ginseng with the ginsenoside in this preparation, the intercalation soil particle specification of children's is every bag of 7g, and every 7g sample particle is with ginsenoside Rg1 (C 42H 72O 14) and ginsenoside Re (C 48H 82O 18) meter, must not be less than 2.75mg.
Stability observing:
3 months reserved sample observing methods are measured the preliminarily stabilised of this preparation, and the result shows that this preparation was stable in 3 months, and its long-time stability await further observation.
The main pharmacodynamics experiment:
Antiinflammatory action: the intercalation soil particle small dose group of children's can significantly suppress the mice auricle swelling that caused by dimethylbenzene.
Analgesic activity: the pain threshold that the big or middle dosage group of the intercalation soil particle of children's can significant prolongation hot plate mice when administration 0.5h, and can significant prolongation acetic acid cause analgesia incubation period of pain mice, that significantly reduces mice turns round the body number of times, and remarkable analgesic activity is arranged.
Effect to intestinal function: the big or middle dosage group of the intercalation soil particle of children's can significantly improve mice charcoal end propelling rate, and big or middle dosage group is absorbed with significant facilitation to the rat small intestine xylose.
Effect to gastric emptying: the large, medium and small dosage group of the intercalation soil particle of children's can significantly increase the gastric emptying ability of mice.
Effect to the gastritis rat model: the large, medium and small dosage group of the intercalation soil particle of children's can significantly reduce the gastric acidity and the gastric juice viscosity of gastritis rat model, dosage group big or middle can significantly reduce the peptic activity of stomach in the gastritis rat model gastric juice, the heavy dose of group of secretory volume that can significantly increase gastrin.
Acute toxicity test:
The intercalation soil particle mice of children's maximum dosage-feeding is 480g/kg, quite and 343 times of people's clinical application amount
Long term toxicity test:
The clinical course of treatment of the intercalation soil particle of children's was two weeks, this experimental observation convalescent period of 2 months long term toxicity of rat continuous use and one month observe.After having observed the long-term gastric infusion of rat, to the toxic reaction that body produced and the degree of reversibility of reaction.The result shows, 2 months whole bodies of rat continuous use do not have the generation of poisoning, rats eating, movable normal, body weight slightly increases, hematology, serum biochemistry are learned relatively no significant difference (p>0.05) of each index and organ coefficient and matched group, and each medication group internal organs of histopathologic examination and matched group relatively there is no obvious pathomorphology and change.

Claims (5)

1. intercalation soil particle of children's, it is characterized in that: by following Chinese herbal medicine is that raw material makes: Radix Ginseng, the Rhizoma Atractylodis Macrocephalae (stir-fry), Poria, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Fructus Hordei Germinatus (stir-fry), Fructus Crataegi (Jiao), Fructus Amomi, Radix Glycyrrhizae.
2. the intercalation soil particle of children's according to claim 1, it is characterized in that: the part by weight of each Chinese medicine of distinguishing the flavor of is:
250~320 parts of Radix Ginsengs
160~220 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry)
160~220 parts in Poria
200~270 parts of Pericarpium Citri Reticulataes
200~270 parts of Rhizoma Cyperis
200~270 parts in Fructus Hordei Germinatus (stir-fry)
200~270 parts of Fructus Crataegis (Jiao)
200~270 parts of Fructus Amomis
100~180 parts in Radix Glycyrrhizae
3. the intercalation soil particle of children's according to claim 2, it is characterized in that: the part by weight of each Chinese medicine of distinguishing the flavor of is:
285 parts of Radix Ginsengs
190 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry)
190 parts in Poria
238 parts of Pericarpium Citri Reticulataes
238 parts of Rhizoma Cyperis
238 parts in Fructus Hordei Germinatus (stir-fry)
238 parts of Fructus Crataegis (Jiao)
238 parts of Fructus Amomis
143 parts in Radix Glycyrrhizae
4. the preparation method of a claim 1, the intercalation soil particle of 2 or 3 described children's is characterized in that may further comprise the steps:
A: the Rhizoma Atractylodis Macrocephalae (stir-fry), Pericarpium Citri Reticulatae, Rhizoma Cyperi, amomum powder are broken into coarse powder, add the water of 5 times of weight, and steam distillation extracted volatile oil 5 hours, collect volatile oil, and distillation rear solution device is in addition collected;
Medicinal residues and Poria, Fructus Hordei Germinatus (stir-fry), Fructus Crataegi (Jiao), Radix Glycyrrhizae that b: step a extracts behind the volatile oil decoct with water secondary, add for the first time 10 times of water gagings, decocted 2 hours, the water that adds for the second time 6 times of amounts, decocted 1 hour, and merged decoction liquor, filter, the aqueous solution that filtrate and step a extract behind the volatile oil merges, and is condensed into the clear paste that relative density is 1.35-1.38 at 55 ℃;
C: the Radix Ginseng powder is broken into coarse powder, adds 50% alcohol heating reflux and extracts secondary, adds 8 times of amounts for the first time, add for the second time 6 times of amounts, the each extraction 2 hours, merge extractive liquid, filters, filtrate recycling ethanol, be condensed into the clear paste that relative density is 1.35-1.38 at 55 ℃, extract clear paste with the step a Rhizoma Atractylodis Macrocephalae, Poria etc. and merge mixing, drying is ground into dry extract;
D: get 5 times of step a volatilization oil mass cycloheptaamyloses, add 20% ethanol of 2 times of dextrin amounts, grind to form pasty state, add above-mentioned volatile oil, ground 2 hours, cold drying is pulverized;
E: combining step c obtains the volatile oil encapsulation object dry powder that extract powder and steps d obtain, and fully mixes, and the mixture that adds dextrin and sugar obtains this product as the adjuvant dry granulation.
5. the preparation method of the intercalation soil particle of children's according to claim 4 is characterized in that: the ratio of sugar and dextrin is 1: 1 in the adjuvant that uses among this step e, and supplementary product consumption is about drug extract powder and volatile oil encapsulation object total amount 1 times.
CNB2004100425258A 2004-05-20 2004-05-20 Infant's Runtu granulars and preparation method Expired - Fee Related CN1292789C (en)

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CN103356946A (en) * 2013-07-30 2013-10-23 吉林省东北亚药业股份有限公司 Children's traditional Chinese medicinal preparation for spleen and stomach reinforcing, qi rectifying and stagnation transforming
CN104825974A (en) * 2015-05-28 2015-08-12 合肥丰瑞隆生物科技有限公司 Traditional Chinese medicine for treating loss of appetite
CN105056092A (en) * 2015-08-21 2015-11-18 北京汉典制药有限公司 Preparation method of ginseng, poria cocos and white atractylodes rhizome granules and prepared ginseng, poria cocos and white atractylodes rhizome granules
CN111821187A (en) * 2020-07-28 2020-10-27 山东明仁福瑞达制药股份有限公司 Traditional Chinese medicine extract powder granulating system and method for treating cervical spondylosis
CN114732883A (en) * 2022-03-02 2022-07-12 湖南天药堂中医药文化产业发展有限公司 Traditional Chinese medicine composition for invigorating spleen and benefiting stomach and preparation method and application thereof
CN115944699A (en) * 2022-12-14 2023-04-11 修正药业集团股份有限公司 Traditional Chinese medicine composition with effects of activating spleen, tonifying qi, promoting digestion and removing food stagnation as well as preparation method and application thereof

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CN103356946A (en) * 2013-07-30 2013-10-23 吉林省东北亚药业股份有限公司 Children's traditional Chinese medicinal preparation for spleen and stomach reinforcing, qi rectifying and stagnation transforming
CN104825974A (en) * 2015-05-28 2015-08-12 合肥丰瑞隆生物科技有限公司 Traditional Chinese medicine for treating loss of appetite
CN105056092A (en) * 2015-08-21 2015-11-18 北京汉典制药有限公司 Preparation method of ginseng, poria cocos and white atractylodes rhizome granules and prepared ginseng, poria cocos and white atractylodes rhizome granules
CN105056092B (en) * 2015-08-21 2019-05-03 北京汉典制药有限公司 A kind of preparation method of granule containing ginseng, Siberian cocklebur, lagehead atractylodes and its granule containing ginseng, Siberian cocklebur, lagehead atractylodes of preparation
CN111821187A (en) * 2020-07-28 2020-10-27 山东明仁福瑞达制药股份有限公司 Traditional Chinese medicine extract powder granulating system and method for treating cervical spondylosis
CN114732883A (en) * 2022-03-02 2022-07-12 湖南天药堂中医药文化产业发展有限公司 Traditional Chinese medicine composition for invigorating spleen and benefiting stomach and preparation method and application thereof
CN114732883B (en) * 2022-03-02 2023-07-25 湖南天药堂中医药文化产业发展有限公司 Traditional Chinese medicine composition for strengthening spleen and tonifying stomach as well as preparation method and application thereof
CN115944699A (en) * 2022-12-14 2023-04-11 修正药业集团股份有限公司 Traditional Chinese medicine composition with effects of activating spleen, tonifying qi, promoting digestion and removing food stagnation as well as preparation method and application thereof
CN115944699B (en) * 2022-12-14 2024-03-15 修正药业集团股份有限公司 Traditional Chinese medicine composition with effects of activating spleen and tonifying qi, and promoting digestion and resolving stagnation, preparation method and application thereof

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