CN112999326A - Spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill and preparation method thereof - Google Patents

Spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill and preparation method thereof Download PDF

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CN112999326A
CN112999326A CN201911316810.7A CN201911316810A CN112999326A CN 112999326 A CN112999326 A CN 112999326A CN 201911316810 A CN201911316810 A CN 201911316810A CN 112999326 A CN112999326 A CN 112999326A
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parts
enteric
pill
spleen
layer
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CN112999326B (en
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彭富全
谢嘉伟
刘敏
石洪超
林庆义
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Guangzhou Baiyunshan Chen Liji Pharmaceutical Factory Co ltd
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Guangzhou Baiyunshan Chen Liji Pharmaceutical Factory Co ltd
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
    • A—HUMAN NECESSITIES
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    • A61K33/00—Medicinal preparations containing inorganic active ingredients
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract

The invention relates to a spleen-tonifying intestine-benefiting gastrointestinal dissolution-type pill and a preparation method thereof. The pill comprises enteric coated inner pill, gastric soluble layer, and transition layer; wherein, the enteric inner pill is prepared from enteric powder; the enteric powder is prepared from the following raw materials: rhizoma corydalis, semen litchi, Zingiberis rhizoma, Glycyrrhrizae radix, radix Saposhnikoviae, radix aucklandiae, fructus Psoraleae and Halloysitum rubrum; the gastric soluble layer is made of gastric soluble powder; the gastric soluble powder is prepared from the following raw materials: radix astragali, radix Codonopsis, fructus Amomi, radix Paeoniae alba, radix Angelicae sinensis, Atractylodis rhizoma and cortex Cinnamomi; the transition layer is prepared from the gastric soluble powder and an adhesive, wherein the adhesive comprises the following components in percentage by weight: 0.5-5% of hydroxypropyl methyl cellulose, 20-65% of water and 30-75% of ethanol. The stomach soluble layer and the enteric layer of the spleen-tonifying intestine-benefiting gastrointestinal separate dissolution type pill are tightly combined, are completely coated, and can effectively ensure that the medicine is timely disintegrated and released in the stomach and the intestinal tract respectively.

Description

Spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill and preparation method thereof
Technical Field
The invention relates to a traditional Chinese medicine preparation, in particular to a spleen-tonifying intestine-benefiting gastrointestinal dissolution-type pill and a preparation method thereof.
Background
Chronic nonspecific ulcerative colitis is clinically common and recurrent chronic inflammatory bowel disease of the colon mucosa and submucosa, and is clinically characterized by abdominal pain, diarrhea or loose stool and mucus or hematochezia. The patients are very painful due to long course of disease, repeated attacks, difficult cure and potential malignant lesion possibility. But also has a self-immune disease with unknown reason, so that very good treatment methods and medicines are rarely available at home and abroad.
Chinese patent CN87106202A discloses a preparation process of a Chinese patent medicine gastrointestinal separately-dissolving type pill, and the gastrointestinal separately-dissolving type Chinese patent medicine double-layer pill of the spleen-tonifying and intestine-benefiting pill can be further prepared according to the preparation process, has the effects of tonifying middle-jiao and Qi, strengthening spleen and warming Yang, and enriching blood and generating blood, is an ideal Chinese patent medicine for treating chronic colitis and ulcerative colitis at present, obtains a medicine approval document for thirty years, and is well favored by patients. The preparation process prepares the original two pills into the internal and external double-layer pills, and plays a good role in reducing the production cost of enterprises, and particularly facilitating the taking of patients. The external layer (gastric soluble layer) of the product formula comprises radix astragali, radix Codonopsis, fructus Amomi, radix Paeoniae alba, radix Angelicae sinensis, Atractylodis rhizoma, and cortex Cinnamomi, and can be used for treating the root cause and the symptoms of spleen qi movement, qi and blood generation, and physical fitness enhancement. The inner layer (enteric coated) comprises rhizoma corydalis, semen litchi, rhizoma Zingiberis Preparata, radix Glycyrrhizae Preparata, radix Saposhnikoviae, radix aucklandiae, fructus Psoraleae processed with salt, and Halloysitum rubrum preparata as the principal medicines. Can be disintegrated in duodenum or small intestine to improve the drug concentration of focus (colon), quickly exert the effects of relieving diarrhea with astringents, relieving spasm and pain, stopping bleeding, promoting granulation and relieving swelling, accelerate the repair and healing of inflammation and ulcer intestinal tissue, and improve the curative effect of the drug.
The preparation process comprises the following steps: 1. pulverizing the outer layer medicine into fine powder, sieving, mixing, sterilizing, and spreading to cool to obtain outer layer powder; 2. pulverizing the inner layer into fine powder, sieving, mixing, adding Mel and appropriate amount of water, making into pill, and drying to obtain inner layer pill; 3. placing the inner layer pill in a sugar coating jar, coating the bottom powder layer with gelatin syrup and bottom powder, and coating the enteric coating layer with shellac mixed solution and appropriate amount of pulvis Talci to meet the requirement; 4. putting the enteric-coated pill into a sugar coating tank, using appropriate amount of refined honey and water as binder, and coating the outer layer powder outside the enteric-coated pill; 5. coating with active carbon, drying, and polishing in a polishing pan until the surface is bright and uniform to obtain the final product.
In the step 4 of the preparation process, the enteric-coated pills are placed in a sugar coating cylinder, and an appropriate amount of refined honey and water are directly used as a mixing agent, so that the outer layer powder is coated outside the enteric coating. In actual production, the situation that the enteric-coated pills cannot be coated by outer-layer powder or the powder is easy to fall off frequently occurs, so that the product quality is unqualified, the rejection rate is increased, and the cost is increased.
Disclosure of Invention
Based on this, there is a need for a gastrointestinal dissolution type pill for invigorating spleen and intestine. The stomach soluble layer and the enteric layer of the spleen-tonifying intestine-benefiting gastrointestinal separate dissolution type pill are tightly combined, are completely coated, and can effectively ensure that the medicine is timely disintegrated and released in the stomach and the intestinal tract respectively.
A pill for invigorating spleen, benefiting intestine, and regulating gastrointestinal function comprises enteric coated inner pill, gastric layer, and transition layer arranged between the enteric coated inner pill and gastric layer;
wherein, the enteric inner pill is prepared from enteric powder; the enteric powder is prepared from the following raw materials: rhizoma corydalis, semen litchi, Zingiberis rhizoma, Glycyrrhrizae radix, radix Saposhnikoviae, radix aucklandiae, fructus Psoraleae and Halloysitum rubrum;
the gastric soluble layer is made of gastric soluble powder; the gastric soluble powder is prepared from the following raw materials: radix astragali, radix Codonopsis, fructus Amomi, radix Paeoniae alba, radix Angelicae sinensis, Atractylodis rhizoma and cortex Cinnamomi;
the transition layer is prepared from the gastric soluble powder and an adhesive, wherein the adhesive comprises the following components in percentage by weight: 0.5-5% of hydroxypropyl methylcellulose (HPMC), 20-65% of water and 30-75% of ethanol.
In one embodiment, the adhesive comprises the following components in percentage by weight: 1-3% of hydroxypropyl methyl cellulose, 40-55% of water and 42-58% of ethanol.
In one embodiment, the transition layer is prepared from the following raw materials in a weight ratio of 1-5: 1 and an adhesive.
In one embodiment, the transition layer is prepared from the following raw materials in a weight ratio of 1-3: 1 and an adhesive.
In one embodiment, the weight ratio of the enteric inner pill, the transition layer and the gastric layer is 3000: 300-600: 3000-4500.
In one embodiment, the viscosity of the hydroxypropyl methylcellulose is 40-50 mPa.s.
In one embodiment, the enteric powder is prepared from the following raw materials in parts by weight: 5-13 parts of rhizoma corydalis, 5-10 parts of lychee seed, 1-4 parts of dried ginger, 5-12 parts of liquorice, 2-7 parts of divaricate saposhnikovia root, 2-6 parts of costustoot, 1-6 parts of fructus psoraleae and 7-17 parts of red halloysite.
In one embodiment, the gastric soluble powder is prepared from the following raw materials in parts by weight: 4-12 parts of astragalus membranaceus, 4-15 parts of codonopsis pilosula, 1-7 parts of fructus amomi, 7-17 parts of radix paeoniae alba, 1-14 parts of angelica sinensis, 5-12 parts of bighead atractylodes rhizome and 1-7 parts of cinnamon.
The invention also provides a preparation method of the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, which comprises the following steps:
the preparation of the enteric-coated powder comprises the following steps: pulverizing rhizoma corydalis, semen litchi, Zingiberis rhizoma, Glycyrrhrizae radix, radix Saposhnikoviae, radix aucklandiae, fructus Psoraleae and Halloysitum rubrum;
the preparation of the gastric soluble powder comprises the following steps: pulverizing radix astragali, radix Codonopsis, fructus Amomi, radix Paeoniae alba, radix Angelicae sinensis, Atractylodis rhizoma and cortex Cinnamomi;
the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps: preparing the enteric-coated powder into pills to obtain enteric-coated inner pills; adding the adhesive and the gastric soluble powder into the enteric inner pill, and preparing a transition layer on the surface of the enteric inner pill; adding the gastric soluble powder, and preparing a gastric soluble layer on the surface of the transition layer; and (4) finishing.
In one embodiment, the adhesive is prepared by the steps of: and adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and then adding the ethanol.
In one embodiment, the step of formulating the enteric powder into a pellet and/or formulating the gastric layer comprises: refined honey and water are adopted for preparing the tea.
Compared with the prior art, the invention has the following beneficial effects:
the invention relates to a spleen-tonifying and intestine-benefiting gastrointestinal dissolution type pill, which is based on medicinal material bases of a spleen-tonifying and intestine-benefiting enteric inner pill and a gastric dissolution layer, wherein a transition layer is arranged between the enteric inner pill and the gastric dissolution layer, the transition layer takes hydroxypropyl methylcellulose as a main bonding component and is prepared by matching ethanol and water in a certain weight percentage, and the spleen-tonifying and intestine-benefiting gastrointestinal dissolution type pill has the advantages that:
(1) the transition layer is tightly combined with the enteric inner pill, the form of the enteric inner pill is not influenced, and meanwhile, the surface of the transition layer has certain roughness, so that the adhesion of gastric powder on the surface of the transition layer can be effectively increased, the coating is complete, and the adhesion is tight, thereby improving the success rate of coating outer-layer powder on the surface of the inner-layer enteric-coated pill, reducing the rejection rate and the production cost, improving the quality of the pill, and effectively solving the process difficulty of the gastrointestinal separately-soluble pill.
(2) The good layered release effect can be achieved by adopting fewer coating layers or times of the gastric soluble layer, the process flow is simplified, and the material cost is also saved.
(3) The hypromellose adopted by the transition layer is part of methyl and part of poly-hydroxypropyl ether of cellulose, can be dissolved in cold water to form a solution with certain viscosity, the property of the hypromellose is close to that of a viscoelastic substance (mainly mucin) in tears, the hypromellose has better human body affinity, the burden of the gastrointestinal tract of a user is not caused additionally, the irritation is small, and meanwhile, in the pharmacokinetics research of the invention, the pill added with the transition layer can still be disintegrated in time to release the medicine (the transition layer is released in the stomach), and the exertion of the medicine effects of the spleen-tonifying and intestine-benefiting pill on the treatment of chronic colitis, ulcerative colitis and the like is not influenced.
(4) The transition layer adopts water and ethanol as hydroxypropyl methylcellulose's solvent, when guaranteeing good adhesion, the simple and solution nature of preparation method is stable, is difficult to the degeneration, accords with the workshop production reality, is difficult to appear the quality risk, and the used equipment of production washs easily moreover, reduces workman's labour greatly and keeps the workshop clean and tidy.
(5) The transition layer adopts raw materials with stable sources, meets the requirements of drug administration regulations, is safe and nontoxic, can be used as a food additive, has low price, is easy to find qualified suppliers, and has industrial practicality.
Detailed Description
The spleen-tonifying, intestine-benefiting, gastrointestinal dissolution type pill and the preparation method thereof of the present invention will be further described in detail with reference to the specific examples below.
Example 1
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 2% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 47% ethanol and 51% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 2;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 340: 3420.
example 2
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 1.3% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 56.7% ethanol and 42% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 3;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 370: 3740.
example 3
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: 1% hydroxypropylmethylcellulose (HPMC, viscosity 50mpa.s), 56% ethanol and 43% water. Adding the hydroxypropyl methylcellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methylcellulose-containing composite material;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 2;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 300: 4000.
example 4
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 1% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 63% ethanol and 36% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 3;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 460: 3820.
example 5
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 0.75% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 63.75% ethanol and 35.5% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 2;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 340: 4360.
example 6
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 1.5% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 37.5% ethanol and 61% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 3;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 430: 3840.
example 7
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 0.5% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 71.25% ethanol and 28.25% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 3;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 410: 3660.
example 8
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 1% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 42.5% ethanol and 56.5% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at 50-60 ℃, and adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 3;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 440: 3960.
example 9
The embodiment is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, and the preparation method comprises the following steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 0.6% hydroxypropyl methyl cellulose (HPMC, viscosity 50mPa.s), 50% ethanol and 49.4% water, adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and then adding the ethanol to obtain the hydroxypropyl methyl cellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 3;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 560: 3480.
comparative example 1
The comparative example is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, the preparation method is basically the same as that of example 1, and the difference is that: the adhesive is formed by mixing 2% of sodium carboxymethylcellulose (viscosity 50mPa.s), 47% of ethanol and 51% of water.
The method comprises the following specific steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 2% sodium carboxymethylcellulose, 47% ethanol and 51% water, adding the sodium carboxymethylcellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and adding the ethanol to obtain the sodium carboxymethylcellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 2;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 340: 3420.
comparative example 2
The comparative example is a spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill, the preparation method is basically the same as that of example 1, and the difference is that: the adhesive is formed by mixing 8% of hydroxypropyl methylcellulose (HPMC, viscosity 50mPa.s), 30% of ethanol and 62% of water.
The method comprises the following specific steps:
(1) the preparation of the enteric-coated powder comprises the following steps: taking 5 parts of rhizoma corydalis, 5 parts of lychee seed, 3 parts of dried ginger, 5 parts of liquorice, 6 parts of divaricate saposhnikovia root, 5 parts of costustoot, 5 parts of fructus psoraleae and 15 parts of red halloysite, and crushing to obtain the traditional Chinese medicine;
(2) the preparation of the gastric soluble powder comprises the following steps: taking 10 parts of astragalus, 7.5 parts of codonopsis pilosula, 3 parts of fructus amomi, 15 parts of radix paeoniae alba, 2.5 parts of angelica sinensis, 5 parts of bighead atractylodes rhizome and 1.5 parts of cinnamon, and crushing to obtain the traditional Chinese medicine;
(3) preparation of the adhesive: taking 2% sodium carboxymethylcellulose, 47% ethanol and 51% water, adding the sodium carboxymethylcellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and adding the ethanol to obtain the sodium carboxymethylcellulose;
(4) the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps:
(4-1) adding a proper amount of refined honey water solution (Baume degree of 30) into the enteric-coated powder to prepare pills, thus obtaining the enteric-coated inner pills;
(4-2) putting the enteric-coated inner pills into a coating cylinder, adding the adhesive and the gastric-soluble powder, and preparing a transition layer on the surfaces of the enteric-coated inner pills, namely transition layer pills; wherein the weight ratio of the adhesive to the gastric soluble powder is 1: 2;
and (4-3) adding the gastric soluble powder and a proper amount of refined honey water solution (Baume degree of 30), preparing a gastric soluble layer on the surface of the transition layer, coating with active carbon according to a conventional process, drying, and polishing in a polishing pot until the surface is bright and uniform.
In the obtained spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill, the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 340: 3420.
the spleen-tonifying, intestine-benefiting, gastrointestinal dissolution type pellets (finished pellets) of the above examples 1 to 9 and comparative examples 1 to 2 were subjected to a performance test:
(II) test results and scores (Table 1).
TABLE 1 comparison of the properties of the finished pellets of examples 1-9 and comparative examples 1-2
Figure BDA0002326040250000151
Figure BDA0002326040250000161
Note: item A: the weight of each kilogram of enteric-coated inner pills is increased by 10 percent, and the required amount (kg) of enteric-coated powder is obtained;
item B: the stomach soluble powder amount (kg) required by the finished pill for increasing weight by 95% is achieved by each kilogram of the transition layer pills;
an "optical head": the outer layer powder can not adhere to the inner core;
"double-layer pill": the existing stomach and intestine-nourishing pills are gastrointestinal dissolution type Chinese patent medicine double-layer pills, namely double-layer pills prepared according to Chinese patent CN87106202A, do not adopt the transition layer, and are hereinafter referred to as double-layer pills.
(III) adhesive Property examination Using example 1 as an example
3.1 Water temperature investigation (Table 2)
TABLE 2 compounding Water temperature survey
Figure BDA0002326040250000171
And (4) conclusion: when the adhesive is prepared, warm water with the temperature of 50-60 ℃ is used for preparing the adhesive, so that the adhesive has a good effect, and is fast and stable in dissolution.
3.2 examination of storage temperature (Table 3)
TABLE 3 storage temperature investigation
Figure BDA0002326040250000172
And (4) conclusion: the adhesive may remain stable at various temperatures.
3.3 comparison of the effects of HPMC preparations of different viscosities
HPMC with viscosity of 15mPa.s, 30mPa.s and 50mPa.s are selected according to HPMC specification with different viscosity, the preparation method of the adhesive is carried out according to the preparation method of the adhesive mentioned in example 1, and a transition layer and finished pills are prepared.
The results are given in tables 4-5 below:
TABLE 4 comparison of the effects of HPMC preparations of different viscosities
Figure BDA0002326040250000173
Figure BDA0002326040250000181
TABLE 5 comparison of the disintegrating effects of HPMC of different viscosities
Figure BDA0002326040250000182
And (4) conclusion: finished pills prepared from HPMC with three viscosities all meet the requirement of disintegration time limit. However, both low viscosity HPMC preparations produced end-products are subject to "blooming" and are easily eluted by aqueous solutions of the refining honey when transitioning to the finished pellets. Thus, an HPMC having a viscosity of 50mPa.s is most desirable for the adhesive.
(IV) examination of the Effect of acetic acid ulcerative colitis Using example 1 as an example
180-220g clean-grade SD rats are randomly divided into 5 groups, and each group comprises 12 rats, namely a normal control group, a model control group, a sulfasalazine group, a spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill (example 1) group and a double-layer pill group.
Except for the normal control group, the other groups are fasted for 24 hours without water, and the model is made according to the acetic acid model method. Rats in each group started to be administered by intragastric administration on day 2 after model creation, and were continuously administered for 14 days, and normal control groups were infused with an equal volume of physiological saline.
After the last administration, fasting for 12h without water, weighing, visually observing colon change, performing colon histomorphology scoring, fixing colon segment (1cm) close to anus by using formaldehyde, embedding paraffin, slicing, HE staining, and observing colon mucosa histological change for scoring.
The scoring method comprises the following steps:
colon histomorphometric scoring criteria:
Figure BDA0002326040250000191
colon pathological tissue damage score:
the disease comprises ulcer inflammation granuloma and fibrosis, and is scored according to existence and severity (0, 1 and 2 points for none, mild and severe), lesion damage depth (1 point to submucosa, 2 points to muscularis and 3 points to serosal layer), and the sum of all the items is the total score.
The scoring results are shown in table 6 below:
TABLE 6 Effect of spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-dividing pill (example 1) on acetic acid type ulcerative colitis
Figure BDA0002326040250000192
Note: p < 0.01 compared to normal control group; comparison with model group##P＜0.01。
The results show that: the spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-dividing pill (example 1) can obviously reduce the damage of colon tissues, and shows that the spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-dividing pill (example 1) has a certain treatment effect on the acetic acid type ulcerative colitis, and is similar to a double-layer pill.
(V) the examination of the Effect of 2, 4, 6-trinitrobenzenesulfonic acid on ethanol-induced colitis in rats was carried out in example 1
180-220g clean-grade SD rats are randomly divided into 5 groups, and each group comprises 12 rats, namely a normal control group, a model control group, a sulfasalazine group, a spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill (example 1) group and a double-layer pill group. Except for the normal control group, other groups are fasted for 24 hours without water, and the model is made by adopting a 2, 4, 6-trinitrobenzene sulfonic acid (TNBS) method. On day 2 after rat model creation, the rats in each group started to be administered with enema for 14 days continuously, and the normal group was injected with an equal volume of physiological saline.
After the rat is dosed for the last time, the rat is fasted for 12 hours without water, after weighing, colon changes are observed by naked eyes, the colon histomorphology scoring is carried out, formaldehyde at a colon section (1cm) close to the anus by 8cm is taken for fixation, paraffin embedding is carried out, slicing is carried out, HE staining is carried out, and the scoring is carried out by observing the colon mucous membrane histology changes. Rat colon tissues were taken and manipulated according to the MPO detection kit instructions.
TABLE 7 Effect of spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill (example 1) on colitis induced in rats by 2, 4, 6-trinitrobenzenesulfonic acid and ethanol
Figure BDA0002326040250000201
Note: p < 0.01 compared to normal control group; comparison with model group##P＜0.01。
The results show that: the spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-dispersing pill (example 1) can obviously reduce the damage of colon tissues, and the content of MPO is reduced, which shows that the spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-dispersing pill (example 1) has a certain treatment effect on 2, 4, 6-trinitrobenzene sulfonic acid type colitis, and is similar to a double-layer pill.
(VI) Process comparison of spleen-invigorating, intestine-benefiting, gastrointestinal dissolution-dividing pill (example 1) with the existing "double-layer pill
6.1 comparison of Key Process parameters (Table 8)
TABLE 8 comparison of key Process parameters
Figure BDA0002326040250000211
Compared with the 'double-layer pill' in the prior art, the pill for reinforcing the spleen, benefiting the intestines, dividing and dissolving the stomach and intestine in the embodiment 1 has the advantages that the using amount of auxiliary materials is reduced, the number of layers required for wrapping the pill to be qualified under the requirement of the same outer layer powder is reduced, and the operation time is saved.
6.2 comparison of the appearance with the external qualification rate (Table 9)
TABLE 9 comparison of phenomena and skin pass
Figure BDA0002326040250000212
Compared with the 'double-layer pill' in the prior art, the operability and the wrapping effect of the pill for reinforcing spleen, benefiting intestine, and dividing and dissolving stomach and intestine of the embodiment 1 are superior to those of the prior art.
6.3 quality comparison (Table 10)
TABLE 10 quality comparison
Figure BDA0002326040250000221
Compared with the 'double-layer pill' in the prior art, the spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-dividing pill in the example 1 has the advantages of low rejection rate, relatively fast disintegration time limit and shorter drug effect exerting time.
In conclusion, in the preparation of the double-layer pill in the prior art, the refined honey has weak fluidity, so that local adhesion is easily caused, and the homogenization is difficult. In addition, since the casing material is alcohol-soluble, there is a difference in material properties from a water-soluble adhesive, and the adhesive force is reduced. The sausage casing has smooth surface and low friction. The reasons are not beneficial to leading the outer layer of the medicine powder to wrap the sausage casing, thereby causing unqualified product quality, increasing rejection rate and increasing cost. The spleen-tonifying intestine-benefiting gastrointestinal dissolution-dividing pill in the embodiment 1 effectively solves the problems of insufficient fluidity and material difference of the adhesive after an improved process of adding a transition layer. The product percent of pass is greatly improved, the adhesive material is easy to obtain, the preparation is convenient, the using amount of the auxiliary material is reduced, the number of layers required for wrapping the same outer layer powder to reach the qualified pill weight is reduced, the operation time is saved, the operation is convenient, and the production practice is met.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. A spleen-tonifying, intestine-benefiting, gastrointestinal dissolution-type pill is characterized by comprising an enteric inner pill, a gastric dissolution layer and a transition layer arranged between the enteric inner pill and the gastric dissolution layer;
wherein, the enteric inner pill is prepared from enteric powder; the enteric powder is prepared from the following raw materials: rhizoma corydalis, semen litchi, Zingiberis rhizoma, Glycyrrhrizae radix, radix Saposhnikoviae, radix aucklandiae, fructus Psoraleae and Halloysitum rubrum;
the gastric soluble layer is made of gastric soluble powder; the gastric soluble powder is prepared from the following raw materials: radix astragali, radix Codonopsis, fructus Amomi, radix Paeoniae alba, radix Angelicae sinensis, Atractylodis rhizoma and cortex Cinnamomi;
the transition layer is prepared from the gastric soluble powder and an adhesive, wherein the adhesive comprises the following components in percentage by weight: 0.5-5% of hydroxypropyl methyl cellulose, 20-65% of water and 30-75% of ethanol.
2. The spleen and intestine tonifying gastrointestinal dissolution type pill according to claim 1, wherein the adhesive comprises the following components in percentage by weight: 1-3% of hydroxypropyl methyl cellulose, 40-55% of water and 42-58% of ethanol.
3. The spleen-tonifying intestine-benefiting gastrointestinal dissolution-type pill according to claim 1, wherein the transition layer is prepared from a mixture of 1-5: 1 and an adhesive.
4. The spleen-tonifying intestine-benefiting gastrointestinal dissolution-type pill according to claim 3, wherein the transition layer is prepared from the following components in a weight ratio of 1-3: 1 and an adhesive.
5. The spleen-tonifying and intestine-benefiting gastrointestinal dissolution type pill according to claim 1, wherein the weight ratio of the enteric inner pill, the transition layer and the gastric dissolution layer is 3000: 300-600: 3000-4500.
6. The spleen-tonifying intestine-benefiting gastrointestinal dissolution-type pill according to claim 1, wherein the viscosity of the hydroxypropylmethylcellulose is 40 to 50 mpa.s.
7. The spleen-tonifying and intestine-benefiting gastrointestinal dissolution type pill according to any one of claims 1 to 6, wherein the enteric powder is prepared from raw materials comprising the following components in parts by weight: 5-13 parts of rhizoma corydalis, 5-10 parts of lychee seed, 1-4 parts of dried ginger, 5-12 parts of liquorice, 2-7 parts of divaricate saposhnikovia root, 2-6 parts of costustoot, 1-6 parts of fructus psoraleae and 7-17 parts of red halloysite; and/or the gastric soluble powder is prepared from the following raw materials in parts by weight: 4-12 parts of astragalus membranaceus, 4-15 parts of codonopsis pilosula, 1-7 parts of fructus amomi, 7-17 parts of radix paeoniae alba, 1-14 parts of angelica sinensis, 5-12 parts of bighead atractylodes rhizome and 1-7 parts of cinnamon.
8. A process for preparing a spleen-tonifying, intestine-benefiting, gastrointestinal dissolution type pellet formulation as claimed in any one of claims 1 to 7, comprising the steps of:
the preparation of the enteric-coated powder comprises the following steps: pulverizing rhizoma corydalis, semen litchi, Zingiberis rhizoma, Glycyrrhrizae radix, radix Saposhnikoviae, radix aucklandiae, fructus Psoraleae and Halloysitum rubrum;
the preparation of the gastric soluble powder comprises the following steps: pulverizing radix astragali, radix Codonopsis, fructus Amomi, radix Paeoniae alba, radix Angelicae sinensis, Atractylodis rhizoma and cortex Cinnamomi;
the spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill is prepared by the following steps: adding auxiliary materials into the enteric-coated powder to prepare pills to obtain the enteric-coated inner pills; adding the adhesive and the gastric soluble powder into the enteric inner pill, and preparing a transition layer on the surface of the enteric inner pill; adding the gastric soluble powder and auxiliary materials, and preparing a gastric soluble layer on the surface of the transition layer; and (4) finishing.
9. The method of claim 8, wherein the step of preparing the adhesive comprises: and adding the hydroxypropyl methyl cellulose into the water, stirring and dissolving at the temperature of 50-60 ℃, and then adding the ethanol.
10. The method of manufacturing according to claim 8 or 9, wherein the step of preparing the enteric powder into a pellet and/or preparing the gastric layer comprises: refined honey and water are adopted for preparing the tea.
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