CN107898942B - Cold clearing capsule and preparation method thereof - Google Patents
Cold clearing capsule and preparation method thereof Download PDFInfo
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- CN107898942B CN107898942B CN201711193292.5A CN201711193292A CN107898942B CN 107898942 B CN107898942 B CN 107898942B CN 201711193292 A CN201711193292 A CN 201711193292A CN 107898942 B CN107898942 B CN 107898942B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/538—Schizonepeta
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K36/233—Bupleurum
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K36/238—Saposhnikovia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/488—Pueraria (kudzu)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/534—Mentha (mint)
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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
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- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/535—Perilla (beefsteak plant)
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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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a capsule for clearing heat for cold and a preparation method thereof. The invention discloses a cold heat clearing capsule, which comprises the following components in parts by weight: 40-60 parts of schizonepeta spike, 10-20 parts of mint, 20-30 parts of divaricate saposhnikovia root, 10-20 parts of perilla leaf, 20-30 parts of kudzuvine root, 10-20 parts of platycodon grandiflorum, 10-20 parts of dahurian angelica root, 40-60 parts of bunge corydalis herb, 30-50 parts of reed rhizome, 20-30 parts of Chinese thorowax root, 15-25 parts of bitter almond, 1-3 parts of modified chitosan, 1-5 parts of beta-cyclodextrin, 0.5-1.5 parts of starch, 1-3 parts of hydroxypropyl cellulose, 85-95 parts of water and 5-15 parts of ethanol solution. The cold-clearing capsule prepared by the invention has the advantages of low hygroscopicity, good stability, high bioavailability, easy disintegration and good clinical curative effect, and the traditional Chinese medicine powder has high fluidity and uniform quality in the preparation process.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a capsule for clearing heat for cold and a preparation method thereof.
Background
The cold is a common disease, and the main symptoms are headache, fever, cough, nasal obstruction, sore throat and the like, which cause certain influence on work and life, even cause complications and cause life risks. The common dosage forms of the existing cold medicines are granules, capsules, tablets and the like, and the existing capsule technology generally adopts the following method, namely, the medicinal materials are identified, processed and dried, then are crushed conventionally, extracted, granulated by a granulation technology, finished and mixed totally to prepare the capsule. However, the existing granulation process is generally amorphous, has the defects of loose and broken granules, poor appearance, poor fluidity, easy moisture absorption, difficult storage and subpackage, low bioavailability, poor curative effect, slow effect and the like of the prepared capsule.
Chinese patent application CN101049485A discloses a mulberry and ginger cold soft capsule and a preparation method thereof, wherein the mulberry and ginger cold soft capsule is prepared from mulberry leaves, chrysanthemum, purple perilla, fructus forsythiae, bitter almond, dried ginger and proper pharmaceutical excipients, and has the effects of dispelling wind, clearing heat, dispelling cold and relieving cough. The capsule has the advantages of stability, rapid disintegration, high bioavailability, and rapid action, but the preparation method has poor powder flowability, causes different loading amount, and is easy to absorb water to affect medicine quality.
Chinese patent CN1254266C discloses an oral capsule for treating common cold, which is prepared by soaking herba Menthae, rhizoma Kaempferiae, and flos Matricariae Chamomillae in water, extracting volatile oil, filtering the distilled water solution, collecting volatile oil, clathrating with beta-cyclodextrin, refrigerating overnight, filtering, drying, grinding, and sieving; decocting the residue with water, filtering, and mixing the filtrate with the distilled water solution; decocting fructus Jujubae, Glycyrrhrizae radix, flos Nymphaeae, fructus Rubi Corchorifolii Immaturus, fructus Althaeae Roseae, radix et rhizoma Rhei, and plantula Papaveris in water, mixing decoctions, filtering, mixing the filtrate with the above solution, concentrating under reduced pressure, adding ethanol, standing, filtering, concentrating the filtrate under reduced pressure, spray drying to obtain extract powder, adding clathrate, mixing, adding microcrystalline cellulose starch, granulating, drying at low temperature, grading, adding silica gel micropowder, mixing, and packaging. The capsule has remarkable curative effect, but the hygroscopicity and the fluidity of the capsule are required to be improved.
Disclosure of Invention
In order to solve the problems in the prior art, the invention aims to provide a cold clearing heat capsule and a preparation method thereof. The cold-clearing capsule provided by the invention has the advantages of low hygroscopicity, good stability, high bioavailability and easy disintegration, and the traditional Chinese medicine powder has high fluidity and uniform quality in the preparation process.
The invention provides a cold heat-clearing capsule, which consists of a pellet, a coating layer and a capsule shell;
the pellet comprises the following components in parts by weight:
40-60 parts of schizonepeta spike, 10-20 parts of mint, 20-30 parts of divaricate saposhnikovia root, 10-20 parts of perilla leaf, 20-30 parts of kudzuvine root, 10-20 parts of platycodon grandiflorum, 10-20 parts of dahurian angelica root, 40-60 parts of bunge corydalis herb, 30-50 parts of reed rhizome, 20-30 parts of Chinese thorowax root, 15-25 parts of bitter almond, 1-3 parts of modified chitosan, 1-5 parts of beta-cyclodextrin, 0.5-1.5 parts of starch, 1-3 parts of hydroxypropyl cellulose, 85-95 parts of water and 5-15 parts of 95% ethanol;
the coating layer comprises the following components in parts by weight:
10-15 parts of hydroxypropyl methylcellulose, 1-3 parts of glycerol triacetate, 1-5 parts of magnesium stearate and 50-60 parts of 95% ethanol.
Further, the pellet in the cold and heat clearing capsule comprises the following components in parts by weight:
50 parts of schizonepeta spike, 15 parts of mint, 25 parts of divaricate saposhnikovia root, 15 parts of perilla leaf, 25 parts of kudzuvine root, 15 parts of platycodon grandiflorum, 15 parts of dahurian angelica root, 50 parts of bunge corydalis herb, 40 parts of reed rhizome, 25 parts of Chinese thorowax root, 20 parts of bitter apricot seed, 2 parts of modified chitosan, 3 parts of beta-cyclodextrin, 1 part of starch, 2 parts of hydroxypropyl cellulose, 90 parts of water and 10 parts of ethanol solution;
the coating layer comprises the following components in parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of glycerol triacetate, 3 parts of magnesium stearate and 50-60 parts of ethanol solution.
Further, the modified chitosan is chitosan-g-lactose.
Further, the preparation method of the chitosan-g-lactose comprises the following steps:
(1) uniformly mixing chitosan and lactose according to the weight ratio of 1:3 to obtain a mixture;
(2) mixing methanol and 0.3 volume percent acetic acid aqueous solution according to the volume ratio of 1:3 to obtain a solvent;
(3) and (3) adding the solvent obtained in the step (2) into the mixture obtained in the step (1), adding sodium cyanoborohydride while stirring, reacting at room temperature for 24 hours, diluting the reacted solution with deionized water, dialyzing with triple distilled water, and freeze-drying to obtain the compound.
Further, the ethanol solution is 85-95% by volume.
Meanwhile, the invention also provides a preparation method of the cold heat clearing capsule, which comprises the following steps:
s1 pulverizing herba Schizonepetae, herba Menthae and folium Perillae to obtain medicinal material A; extracting volatile oil from 6-8 times of water in the medicinal material A by steam distillation for 5-6h, collecting volatile oil, and filtering the solution to obtain filtrate B and residue;
s2 clathrating the volatile oil obtained in the step S1 with beta-cyclodextrin at the clathration temperature of 60 ℃ for 1-2h, refrigerating, suction-filtering, drying, grinding and sieving with a 100-mesh sieve to obtain clathrated powder;
s3 pulverizing radix Saposhnikoviae, radix Puerariae, radix Platycodi, radix Angelicae Dahuricae, herba corydalis Bungeanae, rhizoma Phragmitis, bupleuri radix and semen Armeniacae amarum, and mixing with the residue obtained in step S1 to obtain medicinal material C; adding water 7-9 times the weight of the medicinal material C into the medicinal material C, decocting twice, each time for 1-2h, mixing decoctions, and filtering to obtain filtrate D; mixing the filtrate D with the filtrate B obtained in the step S1, concentrating, spray drying, pulverizing, and sieving with 80 mesh sieve to obtain extract powder;
s4, mixing the extract powder obtained in the step S3 and nano silicon dioxide according to the weight ratio of 99:1, mixing for 5min at the rotating speed of 26r/min, and modifying for 10 times by using a crushing and granulating machine to obtain modified extract powder;
s5, mixing starch, water and ethanol solution uniformly to obtain an adhesive; uniformly mixing the inclusion powder obtained in the step S2, the modified extract powder obtained in the step S3, the modified chitosan and the hydroxypropyl cellulose to obtain mixed powder, preparing a soft material by using the adhesive, extruding the soft material by adopting 45r/min and a screen mesh with the aperture of 1.0mm, rolling the soft material by adopting 12000r/min, then placing the soft material in a fluidized bed for drying, and sieving the soft material by a 40-mesh sieve to obtain pellets;
s6, mixing hydroxypropyl methylcellulose, glycerol triacetate, magnesium stearate and ethanol solution to obtain coating solution; placing the pellets obtained in the step S5 in an air flow coating device, and coating the pellets with the coating solution under the following coating process conditions: the frequency of a blower is 26Hz, the air injection pressure is 0.2MPa, the spray flow rate is 1mL/min, the fluidization temperature is 32 ℃, the coating weight is increased by 4-6%, and pills are obtained; loading the above pills into capsule shell, and sterilizing.
Further, the flow in the step S5The process conditions of the fluidized bed are as follows: air volume is 70-90m3H, the temperature is 40-50 ℃, and the time is 40-60 min.
According to the invention, chitosan-g-lactose is prepared by modifying chitosan, so that the hygroscopicity of the pellet is reduced, the flowability of powder is increased, the quality of the prepared pellet is uniform, and the problem of quality difference in capsule filling is solved; in addition, the volatile oil of the schizonepeta spike, the mint and the perilla leaf is embedded by the beta-cyclodextrin, so that the volatilization of the volatile oil and the contact of the volatile oil with the outside can be effectively reduced, the hygroscopicity of the capsule is reduced, and the stability and the curative effect of the medicine are improved; meanwhile, the invention effectively reduces the friction force among particles and improves the disintegration rate, dissolution and drug stability through the combined action of the hydroxypropyl cellulose and the modified chitosan.
According to the invention, the drug is prepared into the pellet, and the pellet is coated, so that the hygroscopicity of the pellet is effectively reduced, meanwhile, the drug has long duration in blood and small side effect, and the bioavailability and the stability of the drug are improved.
Compared with the prior art, the cold clearing heat capsule prepared by the invention has the advantages of low hygroscopicity, good stability, high bioavailability, easy disintegration and good clinical effect, and the traditional Chinese medicine powder has high fluidity and uniform quality in the preparation process.
Detailed Description
The present invention is further illustrated by the following specific examples, which are provided for illustrative purposes only and do not limit the scope of the present invention.
Example 1A capsule for treating common cold and clearing away heat
The cold clearing heat capsule consists of a pellet, a coating layer and a capsule shell, wherein the pellet, the coating layer and the capsule shell are used for preparing the cold clearing heat capsule
The pellet comprises the following components in parts by weight:
40 parts of schizonepeta spike, 10 parts of mint, 20 parts of divaricate saposhnikovia root, 10 parts of perilla leaf, 20 parts of kudzuvine root, 10 parts of platycodon grandiflorum, 10 parts of angelica dahurica, 40 parts of bunge corydalis herb, 30 parts of reed rhizome, 20 parts of radix bupleuri, 15 parts of bitter almond, 1 part of chitosan-g-lactose, 1 part of beta-cyclodextrin, 0.5 part of starch, 1 part of hydroxypropyl cellulose, 85 parts of water and 5 parts of ethanol solution with the volume fraction of 85%;
the coating layer comprises the following components in parts by weight:
10 parts of hydroxypropyl methylcellulose, 1 part of glycerol triacetate, 1 part of magnesium stearate and 50 parts of ethanol solution with the volume fraction of 85 percent.
The preparation method of the chitosan-g-lactose comprises the following steps:
(1) uniformly mixing chitosan and lactose according to the weight ratio of 1:3 to obtain a mixture;
(2) mixing methanol and 0.3 volume percent acetic acid aqueous solution according to the volume ratio of 1:3 to obtain a solvent;
(3) and (3) adding the solvent obtained in the step (2) into the mixture obtained in the step (1), adding sodium cyanoborohydride while stirring, reacting at room temperature for 24 hours, diluting the reacted solution with deionized water, dialyzing with triple distilled water, and freeze-drying to obtain the compound.
The preparation method comprises the following steps:
s1 pulverizing herba Schizonepetae, herba Menthae and folium Perillae to obtain medicinal material A; extracting volatile oil from 7 times of water in the medicinal material A by steam distillation for 5.5h, collecting volatile oil, and filtering the solution to obtain filtrate B and residue;
s2 clathrating the volatile oil obtained in the step S1 with beta-cyclodextrin at the clathration temperature of 60 ℃ for 1.5h, refrigerating, suction-filtering, drying, grinding and sieving with a 100-mesh sieve to obtain clathrated powder;
s3 pulverizing radix Saposhnikoviae, radix Puerariae, radix Platycodi, radix Angelicae Dahuricae, herba corydalis Bungeanae, rhizoma Phragmitis, bupleuri radix and semen Armeniacae amarum, and mixing with the residue obtained in step S1 to obtain medicinal material C; adding water of 8 times of the weight of the medicinal material C into the medicinal material C in sequence, decocting twice, each time for 1.5h, combining the decoctions, and filtering to obtain filtrate D; mixing the filtrate D with the filtrate B obtained in the step S1, concentrating, spray drying, pulverizing, and sieving with 80 mesh sieve to obtain extract powder;
s4, mixing the extract powder obtained in the step S3 and nano silicon dioxide according to the weight ratio of 99:1, mixing for 5min at the rotating speed of 26r/min, and modifying for 10 times by using a crushing and granulating machine to obtain modified extract powder;
s5 mixing starch, water and 85% ethanol solution by volume fractionUniformly obtaining the adhesive; uniformly mixing the inclusion powder obtained in the step S2, the modified extract powder obtained in the step S3, chitosan-g-lactose and hydroxypropyl cellulose to obtain mixed powder, preparing a soft material by using the adhesive, extruding the soft material by adopting 45r/min and a screen mesh with the aperture of 1.0mm, rolling the soft material by adopting 12000r/min, and then placing the soft material in a fluidized bed for drying, wherein the process conditions of the fluidized bed are as follows: air volume of 70m3The temperature is 40 ℃, the time is 40min, and 40 meshes are sieved to obtain the pellet;
s6, mixing hydroxypropyl methylcellulose, glycerol triacetate, magnesium stearate and 85% ethanol solution by volume fraction to obtain coating solution; placing the pellets obtained in the step S5 in an air flow coating device, and coating the pellets with the coating solution under the following coating process conditions: the frequency of a blower is 26Hz, the air injection pressure is 0.2MPa, the spray flow rate is 1mL/min, the fluidization temperature is 32 ℃, the coating weight is increased by 5 percent, and pills are obtained; loading the above pills into capsule shell, and sterilizing.
Example 2A Cold-clearing Capsule
The cold clearing heat capsule consists of a pellet, a coating layer and a capsule shell, wherein the pellet, the coating layer and the capsule shell are used for preparing the cold clearing heat capsule
The pellet comprises the following components in parts by weight:
50 parts of schizonepeta spike, 15 parts of mint, 25 parts of divaricate saposhnikovia root, 15 parts of perilla leaf, 25 parts of kudzuvine root, 15 parts of platycodon grandiflorum, 15 parts of dahurian angelica root, 50 parts of bunge corydalis herb, 40 parts of reed rhizome, 25 parts of Chinese thorowax root, 20 parts of bitter apricot seed, 2 parts of chitosan-g-lactose, 3 parts of beta-cyclodextrin, 1 part of starch, 2 parts of hydroxypropyl cellulose, 90 parts of water and 10 parts of ethanol solution with volume fraction of 90%;
the coating layer comprises the following components in parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of glycerol triacetate, 3 parts of magnesium stearate and 55 parts of ethanol solution with the volume fraction of 90 percent.
The preparation method of chitosan-g-lactose is similar to that of example 1.
The preparation method comprises the following steps:
except for the fluidized bed process conditions in step S5: air volume of 80m3The procedure is analogous to example 1, except that the temperature is 45 ℃ and the time is 50 min.
Example 3A capsule for treating common cold and clearing away heat
The cold clearing heat capsule consists of a pellet, a coating layer and a capsule shell, wherein the pellet, the coating layer and the capsule shell are used for preparing the cold clearing heat capsule
The pellet comprises the following components in parts by weight:
60 parts of schizonepeta spike, 20 parts of mint, 30 parts of divaricate saposhnikovia root, 20 parts of perilla leaf, 30 parts of kudzuvine root, 20 parts of platycodon grandiflorum, 20 parts of angelica dahurica, 60 parts of bunge corydalis herb, 50 parts of reed rhizome, 30 parts of radix bupleuri, 25 parts of bitter almond, 3 parts of chitosan-g-lactose, 5 parts of beta-cyclodextrin, 1.5 parts of starch, 3 parts of hydroxypropyl cellulose, 95 parts of water and 15 parts of ethanol solution with the volume fraction of 95%;
the coating layer comprises the following components in parts by weight:
15 parts of hydroxypropyl methylcellulose, 3 parts of glycerol triacetate, 5 parts of magnesium stearate and 60 parts of ethanol solution.
The ethanol solution is an ethanol water solution with the volume fraction of 95%.
The preparation method of chitosan-g-lactose is similar to that of example 1.
The preparation method comprises the following steps:
except for the fluidized bed process conditions in step S5: air volume of 90m3The procedure is analogous to example 1, except that the temperature is 50 ℃ and the time is 60 min.
Comparative example 1 Cold-clearing capsule
The cold clearing heat capsule consists of a pellet, a coating layer and a capsule shell, wherein the pellet, the coating layer and the capsule shell are used for preparing the cold clearing heat capsule
The pellet comprises the following components in parts by weight:
50 parts of schizonepeta spike, 15 parts of mint, 25 parts of divaricate saposhnikovia root, 15 parts of perilla leaf, 25 parts of kudzuvine root, 15 parts of platycodon grandiflorum, 15 parts of dahurian angelica root, 50 parts of bunge corydalis herb, 40 parts of reed rhizome, 25 parts of Chinese thorowax root, 20 parts of bitter apricot seed, 2 parts of chitosan, 3 parts of beta-cyclodextrin, 1 part of starch, 2 parts of hydroxypropyl cellulose, 90 parts of water and 10 parts of ethanol solution with volume fraction of 90%;
the coating layer comprises the following components in parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of glycerol triacetate, 3 parts of magnesium stearate and 55 parts of ethanol solution with the volume fraction of 90 percent.
The preparation method is similar to example 2.
The difference from example 2 is that chitosan-g-lactose was replaced by chitosan.
Comparative example 2 Cold-clearing capsule
The cold clearing heat capsule consists of a pellet and a capsule shell, wherein the pellet and the capsule shell are used for preparing the cold clearing heat capsule
The pellet comprises the following components in parts by weight:
50 parts of schizonepeta spike, 15 parts of mint, 25 parts of divaricate saposhnikovia root, 15 parts of perilla leaf, 25 parts of kudzuvine root, 15 parts of platycodon grandiflorum, 15 parts of dahurian angelica root, 50 parts of bunge corydalis herb, 40 parts of reed rhizome, 25 parts of Chinese thorowax root, 20 parts of bitter apricot seed, 2 parts of chitosan-g-lactose, 3 parts of beta-cyclodextrin, 1 part of starch, 2 parts of hydroxypropyl cellulose, 90 parts of water and 10 parts of ethanol solution with volume fraction of 90%.
The preparation method is similar to example 2.
The difference from example 2 is that the cold clearing capsule does not contain a coating layer.
Comparative example 3A capsule for treating common cold and clearing heat
The cold clearing heat capsule consists of a pellet, a coating layer and a capsule shell, wherein the pellet, the coating layer and the capsule shell are used for preparing the cold clearing heat capsule
The pellet comprises the following components in parts by weight:
50 parts of schizonepeta spike, 15 parts of mint, 25 parts of divaricate saposhnikovia root, 15 parts of perilla leaf, 25 parts of kudzuvine root, 15 parts of platycodon grandiflorum, 15 parts of dahurian angelica root, 50 parts of bunge corydalis herb, 40 parts of reed rhizome, 25 parts of Chinese thorowax root, 20 parts of bitter apricot seed, 2 parts of chitosan-g-lactose, 3 parts of beta-cyclodextrin, 1 part of starch, 2 parts of hydroxypropyl cellulose, 90 parts of water and 10 parts of ethanol solution with volume fraction of 90%;
the coating layer comprises the following components in parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of glycerol triacetate, 3 parts of magnesium stearate and 55 parts of ethanol solution with the volume fraction of 90 percent.
The preparation method comprises the following steps:
s1 pulverizing herba Schizonepetae, herba Menthae and folium Perillae to obtain medicinal material A; extracting volatile oil from 7 times of water in the medicinal material A by steam distillation for 5.5h, collecting volatile oil, and filtering the solution to obtain filtrate B and residue;
s2 clathrating the volatile oil obtained in the step S1 with beta-cyclodextrin at the clathration temperature of 60 ℃ for 1.5h, refrigerating, suction-filtering, drying, grinding and sieving with a 100-mesh sieve to obtain clathrated powder;
s3 pulverizing radix Saposhnikoviae, radix Puerariae, radix Platycodi, radix Angelicae Dahuricae, herba corydalis Bungeanae, rhizoma Phragmitis, bupleuri radix and semen Armeniacae amarum, and mixing with the residue obtained in step S1 to obtain medicinal material C; adding water 8 times the weight of the medicinal material C into the medicinal material C, decocting for two times, each time for 1.5h, mixing decoctions, and filtering to obtain filtrate D; mixing the filtrate B and the filtrate D, concentrating, spray drying, pulverizing, and sieving with 80 mesh sieve to obtain extract powder;
s4, uniformly mixing starch, water and 90% ethanol solution by volume fraction to obtain an adhesive; uniformly mixing the inclusion powder obtained in the step S2, the extract powder obtained in the step S3, chitosan-g-lactose and hydroxypropyl cellulose to obtain mixed powder, preparing a soft material by using the adhesive, extruding the soft material by adopting 45r/min and a screen mesh with the aperture of 1.0mm, rolling the soft material by adopting 12000r/min, drying the soft material at 45 ℃, and sieving the soft material by a 40-mesh sieve to obtain pellets;
s5, mixing hydroxypropyl methylcellulose, glycerol triacetate, magnesium stearate and 90% by volume of ethanol solution to obtain coating solution; placing the pellets obtained in the step S4 in an air flow coating device, and coating the pellets with the coating solution under the following coating process conditions: the frequency of a blower is 26Hz, the air injection pressure is 0.2MPa, the spray flow rate is 1mL/min, the fluidization temperature is 32 ℃, the coating weight is increased by 5 percent, and pills are obtained; loading the above pills into capsule shell, and sterilizing.
The difference from example 2 is that the extract powder is not modified in the preparation method, and the pellets are dried conventionally.
Test example I, flowability and filling amount difference test
1. Fluidity test:
the angle of repose was measured by the fixed cone method using the mixed powders in steps S5 of examples 1 to 3 and comparative example 1 and the mixed powder in step S4 of comparative example 3. The angle of repose is a method for testing the flowability of the powder, the smaller the angle of repose is, the smaller the friction force is, the better the flowability is, and the requirement of producing the flowability can be met when the angle of repose of the general powder particles is less than 40 degrees.
2. Load difference test
The capsules for treating cold and clearing heat prepared in examples 1-3 and comparative examples 1 and 3 were tested for difference in loading according to the method for detecting difference in loading in 10 capsules according to the third division of general rules of the "Chinese pharmacopoeia" 2015 edition.
3. And (3) test results: the results of the measurement of the difference between the fluidity and the loading are shown in Table 1.
TABLE 1 measurement results of differences in fluidity and loading
| Group of | Example 1 | Example 2 | Example 3 | Comparative example 1 | Comparative example 3 |
| Angle of repose | 25.7° | 25.2° | 26.3° | 31.2° | 34.5° |
| Limit of difference of loading | ±5.2％ | ±5.0％ | ±5.5％ | ±6.5％ | ±7.5％ |
As can be seen from Table 1, the difference of the filling amount of the cold-clearing capsule meets the regulations, and the mixed powder has better fluidity during the preparation. Compared with comparative examples 1 and 3, the invention improves the fluidity of mixed powder by modifying chitosan and extract powder, further improves the quality of capsules, reduces the difference of filling amount, and has the best effect in example 2.
Test example two, moisture absorption test
(1) Placing the supersaturated sodium chloride solution in a glass dryer at room temperature to balance the internal humidity thereof to form an environment with different relative humidity, wherein the relative humidity of the dryer is 75%;
(2) drying the pills prepared in the examples 1-3 and the comparative examples 1-2 to constant weight, placing 1.0g of the pills dried to constant weight in a flat weighing bottle with constant weight, precisely weighing, opening a weighing bottle cap, placing in a dryer with the relative humidity of 75%, weighing after 48 hours, and calculating the moisture absorption rate, wherein the calculation formula is as follows:
moisture absorption rate [% ], [% ] (weight after moisture absorption-weight before moisture absorption)/weight before moisture absorption × 100%,
the hygroscopicity results are shown in Table 2.
TABLE 2 results of moisture absorption
| Group of | Example 1 | Example 2 | Example 3 | Comparative example 1 | Comparative example 2 |
| Moisture absorption rate/%) | 15.12 | 14.56 | 15.78 | 20.21 | 22.32 |
As can be seen from Table 2, the pills prepared by the present invention have low hygroscopicity and a moisture absorption rate of 14.56-15.78%. Compared with the comparative example 1, the moisture absorption rate of the pill prepared in the example 2 of the invention is reduced by 28 percent, which shows that the moisture absorption capacity of the pill is effectively reduced by adding the chitosan-g-lactose in the invention; compared with the comparative example 2, the moisture absorption rate of the pill prepared in the example 2 of the invention is reduced by 35%, which shows that the moisture absorption capacity of the pill can be relieved by coating the pill by adopting the coating technology.
Test example III stability test
1. Test materials: the cold-clearing capsules prepared in examples 1-3 and comparative examples 1-3.
2. The test method comprises the following steps:
the product is placed under the condition of commercial package at the temperature of 25 +/-2 ℃ and the relative humidity of 60 +/-10% for 36 months, and is sampled once in each of 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and 36 months, and according to the quality standard of the cold and heat clearing capsule, the items such as character, identification, water content, disintegration time limit, content difference, extract, content, microorganism limit inspection and the like are detected.
3. And (3) test results: the stability test results are shown in table 3.
TABLE 3 stability test results
As can be seen from Table 3, the cold-clearing capsule prepared by the invention has good stability in long-term storage. Compared with comparative examples 1-3, the capsule for treating cold and clearing heat prepared in the embodiment 2 of the invention has better stability, which indicates that the capsule for treating cold and clearing heat prepared in the invention has small hygroscopicity, is not easy to deteriorate in long-term storage and has stable property.
Test example four, clinical efficacy test
1. Test materials: the cold-clearing capsules prepared in examples 1-3 and comparative example 1.
2. Test subjects:
220 patients with wind-cold type common cold, age 18-60 years, symptoms: headache, fever, aversion to cold, body pain, runny nose, cough, dry throat, nausea, anorexia, etc.
3. The test method comprises the following steps:
the preparation is administered orally 3 granules at a time 2 times a day after meals, and the treatment course is 3 days.
The evaluation standard of curative effect is as follows:
and (3) curing: the clinical symptoms disappear, and the headache, fever, aversion to cold, body pain, nasal discharge, cough, dry throat, nausea and anorexia disappear.
The effect is shown: the clinical symptoms basically disappear, and the headache, fever, nasal discharge, cough, dry throat, aversion to cold, body pain, nausea and anorexia are obviously improved.
The method has the following advantages: the clinical symptoms are improved to a certain extent, the symptoms of headache, fever, nasal discharge, cough, dry throat are improved, and the symptoms of aversion to cold, body pain, nausea, anorexia and the like are improved to a certain extent.
And (4) invalidation: the clinical symptoms are not improved, and the symptoms of headache, fever, aversion to cold, body pain, nasal discharge, cough, dry throat, nausea and anorexia are not improved.
4. And (3) test results: the results of clinical efficacy are shown in table 4.
TABLE 4 results of clinical effects
| Group of | Example number/person | Healing/human body | Show effect/human | Effective/human | Invalid/human | Total effective rate/%) |
| Example 1 | 55 | 16 | 31 | 6 | 2 | 96.4 |
| Example 2 | 55 | 18 | 33 | 3 | 1 | 98.2 |
| Example 3 | 55 | 15 | 30 | 8 | 2 | 96.4 |
| Comparative example 1 | 55 | 10 | 9 | 83.6 |
As can be seen from Table 4, the cold and heat clearing capsule prepared by the invention has better clinical curative effect and high bioavailability, and can effectively relieve the symptoms of headache, fever, aversion to cold, body pain, nasal discharge, cough, dry throat, nausea, anorexia and the like caused by wind-cold.
In conclusion, the cold clearing capsule prepared by the invention has the advantages of low hygroscopicity, good stability, high bioavailability, easy disintegration and good clinical curative effect, and the traditional Chinese medicine powder has high fluidity and uniform quality in the preparation process. In addition, all indexes of the cold clearing capsule prepared in the embodiment 2 of the invention are superior to those of the embodiments 1 and 3, and the cold clearing capsule is the best embodiment of the invention.
Claims (5)
1. A capsule for treating cold and clearing heat is characterized in that the capsule consists of a pellet, a coating layer and a capsule shell; the pellet comprises the following components in parts by weight:
40-60 parts of schizonepeta spike, 10-20 parts of mint, 20-30 parts of divaricate saposhnikovia root, 10-20 parts of perilla leaf, 20-30 parts of kudzuvine root, 10-20 parts of platycodon grandiflorum, 10-20 parts of dahurian angelica root, 40-60 parts of bunge corydalis herb, 30-50 parts of reed rhizome, 20-30 parts of Chinese thorowax root, 15-25 parts of bitter almond, 1-3 parts of modified chitosan, 1-5 parts of beta-cyclodextrin, 0.5-1.5 parts of starch, 1-3 parts of hydroxypropyl cellulose, 85-95 parts of water and 5-15 parts of ethanol solution;
the coating layer comprises the following components in parts by weight:
10-15 parts of hydroxypropyl methylcellulose, 1-3 parts of glycerol triacetate, 1-5 parts of magnesium stearate and 50-60 parts of ethanol solution;
the modified chitosan is chitosan-g-lactose;
the preparation method of the chitosan-g-lactose comprises the following steps:
(1) uniformly mixing chitosan and lactose according to the weight ratio of 1:3 to obtain a mixture;
(2) mixing methanol and 0.3 volume percent acetic acid aqueous solution according to the volume ratio of 1:3 to obtain a solvent;
(3) and (3) adding the solvent obtained in the step (2) into the mixture obtained in the step (1), adding sodium cyanoborohydride while stirring, reacting at room temperature for 24 hours, diluting the reacted solution with deionized water, dialyzing with triple distilled water, and freeze-drying to obtain the compound.
2. The capsule for clearing heat from cold is characterized in that the pellet raw materials comprise the following components in parts by weight:
50 parts of schizonepeta spike, 15 parts of mint, 25 parts of divaricate saposhnikovia root, 15 parts of perilla leaf, 25 parts of kudzuvine root, 15 parts of platycodon grandiflorum, 15 parts of dahurian angelica root, 50 parts of bunge corydalis herb, 40 parts of reed rhizome, 25 parts of Chinese thorowax root, 20 parts of bitter apricot seed, 2 parts of modified chitosan, 3 parts of beta-cyclodextrin, 1 part of starch, 2 parts of hydroxypropyl cellulose, 90 parts of water and 10 parts of 95% ethanol;
the coating layer comprises the following components in parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of glycerol triacetate, 3 parts of magnesium stearate and 55 parts of ethanol solution.
3. The capsule according to claim 1 or 2, wherein the ethanol solution is 85-95% by volume.
4. The method for preparing a capsule for treating cold and clearing heat according to claim 1, comprising the following steps:
s1 pulverizing herba Schizonepetae, herba Menthae and folium Perillae to obtain medicinal material A; adding 6-8 times of water into the medicinal material A, extracting volatile oil by steam distillation for 5-6h, collecting volatile oil, and filtering the solution to obtain filtrate B and residue;
s2 clathrating the volatile oil obtained in the step S1 with beta-cyclodextrin at the clathration temperature of 60 ℃ for 1-2h, refrigerating, suction-filtering, drying, grinding and sieving with a 100-mesh sieve to obtain clathrated powder;
s3 pulverizing radix Saposhnikoviae, radix Puerariae, radix Platycodi, radix Angelicae Dahuricae, herba corydalis Bungeanae, rhizoma Phragmitis, bupleuri radix and semen Armeniacae amarum, and mixing with the residue obtained in step S1 to obtain medicinal material C; adding water 7-9 times the weight of the medicinal material C into the medicinal material C, decocting twice, each time for 1-2h, mixing decoctions, and filtering to obtain filtrate D; mixing the filtrate D with the filtrate B obtained in the step S1, concentrating, spray drying, pulverizing, and sieving with 80 mesh sieve to obtain extract powder;
s4, mixing the extract powder obtained in the step S3 and nano silicon dioxide according to the weight ratio of 99:1, mixing for 5min at the rotating speed of 26r/min, and modifying for 10 times by using a crushing and granulating machine to obtain modified extract powder;
s5, mixing starch, water and ethanol solution uniformly to obtain an adhesive; uniformly mixing the inclusion powder obtained in the step S2, the modified extract powder obtained in the step S3, the modified chitosan and the hydroxypropyl cellulose to obtain mixed powder, preparing a soft material by using the adhesive, extruding the soft material by adopting 45r/min and a screen mesh with the aperture of 1.0mm, rolling the soft material by adopting 12000r/min, then placing the soft material in a fluidized bed for drying, and sieving the soft material by a 40-mesh sieve to obtain pellets;
s6, mixing hydroxypropyl methylcellulose, glycerol triacetate, magnesium stearate and ethanol solution to obtain coating solution; placing the pellets obtained in the step S5 in an air flow coating device, and coating the pellets with the coating solution under the following coating process conditions: the frequency of a blower is 26Hz, the air injection pressure is 0.2MPa, the spray flow rate is 1mL/min, the fluidization temperature is 32 ℃, the coating weight is increased by 4-6%, and pills are obtained; loading the above pills into capsule shell, and sterilizing.
5. The method for preparing a capsule for clearing away heat from cold according to claim 4, wherein the fluidized bed process conditions in step S5 are as follows: air volume is 70-90m3H, the temperature is 40-50 ℃, and the time is 40-60 min.
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