CN110772492A - Preparation method of cold capsule - Google Patents

Preparation method of cold capsule Download PDF

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Publication number
CN110772492A
CN110772492A CN201911049712.1A CN201911049712A CN110772492A CN 110772492 A CN110772492 A CN 110772492A CN 201911049712 A CN201911049712 A CN 201911049712A CN 110772492 A CN110772492 A CN 110772492A
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capsule
temperature
freezing
taking
crushing
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冯东东
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • A61K36/195Strobilanthes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/17Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315Isatis, e.g. Dyer's woad
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634Forsythia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/78Saururaceae (Lizard's-tail family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8962Allium, e.g. garden onion, leek, garlic or chives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Veterinary Medicine (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

A preparation method of a capsule for treating cold comprises pre-freezing fructus forsythiae, herba Ephedrae, Bulbus Allii Fistulosi, rhizoma Zingiberis recens, and herba Houttuyniae at-30-35 deg.C, freezing at low temperature, and pulverizing into nanopowder; taking radix isatidis as a carrier, taking copovidone Plasdone-630 as an auxiliary material in a ratio of 6-9: 2-1, adopting a hot-melt extrusion technology, extruding the material in a strip shape from a die hole of a machine head, connecting the extruded material in an aluminum disc, crushing, and sieving with a 100-200-mesh sieve for later use; mixing the nanopowder and the powder, boiling, granulating, and making into capsule. The invention has high automation degree, high production efficiency, high bioavailability, stable product quality and low cost; the prepared medicine has safe and reliable curative effect and stable and controllable quality, and the medicine is more reasonable, economic, safe and effective to use.

Description

Preparation method of cold capsule
Technical Field
The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a preparation method of a cold capsule.
Background
The common cold is caused by external wind, and has the main clinical manifestations of nasal obstruction, watery nasal discharge, cough, aversion to cold, fever and pain of head and body. The cold should be treated in time. However, Western medicines are poor in treatment effect, large in side effect and not obvious in treatment effect. The traditional Chinese medicine for treating cold has a good effect on treating cold, has no side effect, is low in price and is easy to purchase.
Disclosure of Invention
The invention aims to provide a preparation method of a cold capsule, which solves the problem of great side effect of western medicines for treating cold in the prior art.
The invention adopts the technical scheme that a preparation method of a cold capsule is implemented according to the following steps:
step 1, weighing 22-28% of isatis root, 22-28% of forsythia, 22-28% of ephedra, 10-16% of fistular onion stalk, 10-16% of ginger and 0.3-0.9% of cordate houttuynia according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing fructus forsythiae, ephedra, fistular onion stalk, ginger and houttuynia cordata at the temperature of-30 to-35 ℃ for 60 to 70 minutes, freezing and crushing at low temperature for 15 to 20 minutes to obtain nano powder of 700 to 800 meshes for later use;
step 3, taking copovidone Plasdone-630 as a carrier, taking the radix isatidis as an auxiliary material in a ratio of 6-9: 2-1, adopting a hot-melt extrusion technology, carrying out a temperature of 20-50 ℃, carrying out a screw rotation speed of 400-700 rpm, extruding the material in a strip shape from a die hole of a machine head, connecting the extruded material in an aluminum disc, standing for 3-4 hours at room temperature, crushing, and sieving with a 100-200-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, boiling and granulating, and filling into capsules to obtain the capsule.
The invention is also characterized in that:
the technological parameters of the boiling granulation in the step 4 are as follows: the atomization rate is 30-50 Hz, the atomization pressure is 0.3-0.5 Mpa, the air inlet temperature is 80-90 ℃, and the air outlet temperature is 60-70 ℃.
The invention has the beneficial effects that: the invention has high automation degree, high production efficiency, high bioavailability, stable product quality, safe and convenient operation and low cost, and the whole production process meets the GMP requirement; the prepared medicine has safe and reliable curative effect and stable and controllable quality, and the preparation method improves the bioavailability of the traditional Chinese medicines of the medicine, so that the medicine is more reasonable, economic, safe and effective to use.
Detailed Description
The present invention will be described in detail with reference to the following embodiments.
The invention relates to a preparation method of a cold capsule, which is implemented according to the following steps:
step 1, weighing 22-28% of isatis root, 22-28% of forsythia, 22-28% of ephedra, 10-16% of fistular onion stalk, 10-16% of ginger and 0.3-0.9% of cordate houttuynia according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing fructus forsythiae, ephedra, fistular onion stalk, ginger and houttuynia cordata at the temperature of-30 to-35 ℃ for 60 to 70 minutes, freezing and crushing at low temperature for 15 to 20 minutes to obtain nano powder of 700 to 800 meshes for later use;
step 3, taking copovidone Plasdone-630 as a carrier, taking the radix isatidis as an auxiliary material in a ratio of 6-9: 2-1, adopting a hot-melt extrusion technology, carrying out a temperature of 20-50 ℃, carrying out a screw rotation speed of 400-700 rpm, extruding the material in a strip shape from a die hole of a machine head, connecting the extruded material in an aluminum disc, standing for 3-4 hours at room temperature, crushing, and sieving with a 100-200-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, and performing boiling granulation, wherein the technological parameters of the boiling granulation are as follows: the atomization rate is 30-50 Hz, the atomization pressure is 0.3-0.5 Mpa, the air inlet temperature is 80-90 ℃, the air outlet temperature is 60-70 ℃, and the capsule is prepared.
Compared with the existing preparation method, the preparation method of the invention mainly has the following technical advantages:
1. freezing nanometer crushing technology: the raw materials can be crushed to the nanometer level, the particle size distribution range is narrower, namely the particle size is more uniform; the cell wall of the medicinal materials is destroyed, the absorption of effective components is facilitated, and the bioavailability is higher.
2. Preparing a solid dispersion by adopting a hot-melt extrusion technology: the solid dispersion prepared from the houttuynia cordata by adopting a hot-melt extrusion technology has the advantages of higher dissolution speed, more stable active ingredients and more accurate dosage, and improves the bioavailability and the utilization rate of valuable medicinal materials.
Example 1
Step 1, weighing 22% of isatis root, 23.5% of forsythia, 28% of ephedra, 10% of costus root, 16% of fistular onion stalk and 0.5% of heartleaf houttuynia herb according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing radix isatidis, fructus forsythiae, ephedra, elecampane and fistular onion stalk for 60 minutes at the temperature of-30 ℃, freezing and crushing for 25 minutes at low temperature to obtain nano powder of 700 meshes for later use;
step 3, taking the isatis root fine powder as a carrier by taking copovidone Plasdone-630 as an auxiliary material, wherein the raw material ratio is 7: 3, adopting a hot-melt extrusion technology, extruding the materials in a strip shape from a die hole of a machine head at the temperature of 35 ℃ and the rotating speed of a screw rod of 550 r/min, connecting the extruded material into an aluminum disc, standing for 3 hours at room temperature, crushing, and sieving with a 100-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, and performing boiling granulation, wherein the technological parameters of the boiling granulation are as follows: atomizing at 30Hz and 0.3Mpa at 90 deg.C, and air-out at 60 deg.C, and making into capsule.
Example 2
Step 1, respectively weighing 25% of isatis root, 22% of forsythia, 25% of ephedra, 16% of costus root, 11.6% of fistular onion stalk and 0.4% of heartleaf houttuynia herb according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing radix isatidis, fructus forsythiae, ephedra, elecampane and fistular onion stalk at the temperature of-35 ℃ for 65 minutes, freezing and crushing at low temperature for 20 minutes to obtain 800-mesh nano powder for later use;
step 3, taking the isatis root fine powder as a carrier by taking copovidone Plasdone-630 as an auxiliary material, wherein the raw material and auxiliary material ratio is 9: 1, adopting a hot-melt extrusion technology, extruding materials in a strip shape from a die hole of a machine head at the temperature of 30 ℃ and the rotating speed of a screw rod of 600 revolutions per minute, connecting the extruded material into an aluminum disc, standing for 4 hours at room temperature, crushing, and sieving with a 200-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, and performing boiling granulation, wherein the technological parameters of the boiling granulation are as follows: atomizing at 40Hz and 0.4Mpa at 90 deg.C, and air-out at 70 deg.C, and making into capsule.
Example 3
Step 1, respectively weighing 26% of isatis root, 26% of forsythia, 22% of ephedra, 13% of costus root, 12.1% of fistular onion stalk and 0.9% of heartleaf houttuynia herb according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing radix isatidis, fructus forsythiae, ephedra, elecampane and fistular onion stalk at the temperature of-33 ℃ for 70 minutes, freezing and crushing at low temperature for 23 minutes to obtain nano powder of 750 meshes for later use;
step 3, taking the isatis root fine powder as a carrier by taking copovidone Plasdone-630 as an auxiliary material, wherein the raw material and auxiliary material ratio is 8: 2, adopting a hot-melt extrusion technology, extruding the materials in a strip shape from a die hole of a machine head at the temperature of 40 ℃ and the rotating speed of a screw rod of 500 r/min, connecting the extruded material into an aluminum disc, standing for 3.5h at room temperature, crushing, and sieving by a 150-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, and performing boiling granulation, wherein the technological parameters of the boiling granulation are as follows: atomizing at 40Hz and 0.5Mpa at 85 deg.C, and air-out at 65 deg.C, and making into capsule.
Example 4
Step 1, respectively weighing 28% of isatis root, 28% of fructus forsythiae, 22% of ephedra, 11.7% of elecampane, 10% of fistular onion stalk and 0.3% of houttuynia cordata according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing radix isatidis, fructus forsythiae, ephedra, elecampane and fistular onion stalk for 68 minutes at the temperature of-32 ℃, freezing and crushing for 24 minutes at low temperature to obtain 780-mesh nano powder for later use;
step 3, taking the isatis root fine powder as a carrier by taking copovidone Plasdone-630 as an auxiliary material, wherein the raw material and auxiliary material ratio is 8: 2, adopting a hot-melt extrusion technology, wherein the temperature is 38 ℃, the rotating speed of a screw is 530 rpm, extruding the material in a strip shape from a die hole of a machine head, connecting the extruded material into an aluminum disc, standing for 3.6 hours at room temperature, crushing, and sieving by a 180-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, and performing boiling granulation, wherein the technological parameters of the boiling granulation are as follows: atomizing at 50Hz and 0.3Mpa at 80 deg.C, and air-out at 65 deg.C, and making into capsule.

Claims (2)

1. The preparation method of the cold capsule is characterized by comprising the following steps:
step 1, weighing 22-28% of isatis root, 22-28% of forsythia, 22-28% of ephedra, 10-16% of fistular onion stalk, 10-16% of ginger and 0.3-0.9% of cordate houttuynia according to the weight percentage, wherein the sum of the weight percentages of the components is 100%;
step 2, pre-freezing fructus forsythiae, ephedra, fistular onion stalk, ginger and houttuynia cordata at the temperature of-30 to-35 ℃ for 60 to 70 minutes, freezing and crushing at low temperature for 15 to 20 minutes to obtain nano powder of 700 to 800 meshes for later use;
step 3, taking copovidone Plasdone-630 as a carrier, taking the radix isatidis as an auxiliary material in a ratio of 6-9: 2-1, adopting a hot-melt extrusion technology, carrying out a temperature of 20-50 ℃, carrying out a screw rotation speed of 400-700 rpm, extruding the material in a strip shape from a die hole of a machine head, connecting the extruded material in an aluminum disc, standing for 3-4 hours at room temperature, crushing, and sieving with a 100-200-mesh sieve for later use;
and 4, uniformly mixing the nano powder obtained in the step 2 and the powder obtained in the step 3, boiling and granulating, and filling into capsules to obtain the capsule.
2. The method for preparing a capsule for treating cold as claimed in claim 1, wherein the process parameters of the boiling granulation in the step 4 are as follows: the atomization rate is 30-50 Hz, the atomization pressure is 0.3-0.5 Mpa, the air inlet temperature is 80-90 ℃, and the air outlet temperature is 60-70 ℃.
CN201911049712.1A 2019-10-31 2019-10-31 Preparation method of cold capsule Pending CN110772492A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1430984A (en) * 2003-01-04 2003-07-23 辽宁中医学院 Detoxification capsule and its prodn. methods
CN1583073A (en) * 2004-05-24 2005-02-23 谢国云 Chinese patent medicinal prescription for catch-cold
CN102429979A (en) * 2011-12-14 2012-05-02 钟跃平 A Chinese medicinal composition for treating common cold, and its preparation method
CN104189153A (en) * 2014-09-15 2014-12-10 彭海明 Medicine for treating cold and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1430984A (en) * 2003-01-04 2003-07-23 辽宁中医学院 Detoxification capsule and its prodn. methods
CN1583073A (en) * 2004-05-24 2005-02-23 谢国云 Chinese patent medicinal prescription for catch-cold
CN102429979A (en) * 2011-12-14 2012-05-02 钟跃平 A Chinese medicinal composition for treating common cold, and its preparation method
CN104189153A (en) * 2014-09-15 2014-12-10 彭海明 Medicine for treating cold and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
刘落宪主编: "《中药制药工程原理与设备 第2版》", 31 May 2007, 中国中医药出版社 *
方亮: "《药剂学 第3版》", 31 March 2016, 中国医药科技出版社 *

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