CN113384650B - Preparation method of infantile lung-heat cough and asthma granules - Google Patents

Preparation method of infantile lung-heat cough and asthma granules Download PDF

Info

Publication number
CN113384650B
CN113384650B CN202110661152.6A CN202110661152A CN113384650B CN 113384650 B CN113384650 B CN 113384650B CN 202110661152 A CN202110661152 A CN 202110661152A CN 113384650 B CN113384650 B CN 113384650B
Authority
CN
China
Prior art keywords
clear paste
temperature
filtrate
fluid extract
decocting
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN202110661152.6A
Other languages
Chinese (zh)
Other versions
CN113384650A (en
Inventor
刘景萍
刘全国
陈克领
林海银
吴育强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hainan Huluwa Pharmaceutical Group Co ltd
Original Assignee
Hainan Huluwa Pharmaceutical Group Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hainan Huluwa Pharmaceutical Group Co ltd filed Critical Hainan Huluwa Pharmaceutical Group Co ltd
Priority to CN202110661152.6A priority Critical patent/CN113384650B/en
Publication of CN113384650A publication Critical patent/CN113384650A/en
Application granted granted Critical
Publication of CN113384650B publication Critical patent/CN113384650B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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)
    • A61K36/19Acanthaceae (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
    • A61K36/18Magnoliophyta (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)
    • A61K36/35Caprifoliaceae (Honeysuckle family)
    • A61K36/355Lonicera (honeysuckle)
    • 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)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • 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)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539Scutellaria (skullcap)
    • 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)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
    • 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
    • A61K36/8964Anemarrhena
    • 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
    • A61K36/8968Ophiopogon (Lilyturf)
    • 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
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/10Expectorants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/14Antitussive agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention provides a preparation method of particles for treating cough and asthma caused by lung heat of children, which comprises the following steps: (1) Soaking Glycyrrhrizae radix, flos Lonicerae, semen Armeniacae amarum, and rhizoma anemarrhenae in hot water, adding pulverized Gypsum Fibrosum, radix Isatidis, radix Ophiopogonis, and herba Houttuyniae during decocting, and filtering to obtain filtrate 1; (2) Pulverizing herba Ephedrae, fructus forsythiae, and Scutellariae radix, soaking in hot water, decocting repeatedly, and filtering to obtain filtrate 2; (3) Concentrating the filtrate 1 and filtrate 2 under reduced pressure to obtain fluid extract 1 and fluid extract 2, and refrigerating the fluid extract 1 with mannitol for a long time; (4) Mixing the fluid extract 1 and fluid extract 2, preheating with hot air, spray drying, adding sodium cyclamate powder, and hot air drying. The granules for treating infantile lung-heat cough and asthma prepared by the invention are fresh and sweet in taste, good in stability, high in content of effective components and good in curative effect.

Description

Preparation method of infantile lung-heat cough and asthma granules
Technical Field
The invention relates to the field of preparation of medicinal preparations, in particular to a preparation method of particles for treating infantile lung heat cough and asthma.
Background
The infantile lung-heat cough and asthma particle is a compound preparation of eleven traditional Chinese medicines, has the functions of clearing heat and detoxicating, freeing lung and relieving cough, and reducing phlegm and asthma, and is mainly used for cold, bronchitis, asthmatic bronchitis and bronchopneumonia caused by phlegm-heat obstructing lung. In order to improve the sweetness of the mouthfeel, make children more easily accept the sweetness and increase the compliance of clinical use of the children, a process of adding auxiliary materials is usually adopted to prepare the sugar-type specification medicament. In general, sucrose, which is selected as an adjuvant, is widely used in oral preparations because it can be used not only as a filler but also as a sweetener. However, sucrose tends to absorb moisture and become damp, and the addition of an excessive amount of sugar is not favorable for the growth of children. The traditional Chinese medicine extract has high viscosity, and the prepared finished product has unstable quality and low curative effect when being mixed with auxiliary materials, and the solution stability is not high. For example, application number CN108553578a discloses a preparation method of 4 g of granules for treating cough and asthma due to lung heat in children, which improves the cough and asthma relieving effects of the product; the application number CN101780214A discloses a preparation method of children lung-heat cough and asthma granules, which enables baicalin identification items in products to be qualified and improves the product qualification rate. But only respectively improves the stability of the ephedra content and the baicalin content, and does not relate to the research on the granular mouthfeel.
Disclosure of Invention
Therefore, the invention aims to provide the preparation method of the infantile lung heat cough and asthma particle, so that the prepared particle has fresh and sweet taste, good stability, high content of effective components and good curative effect.
The technical scheme of the invention is realized as follows:
a preparation method of the infantile lung-heat cough and asthma particle comprises the following steps:
s1 comprises 24 parts by mass: 10:10:10 weighing gypsum, radix isatidis, radix ophiopogonis and herba houttuyniae respectively, crushing, and sieving by 60-80 meshes to obtain mixed crushed materials;
s2, mixing the following components in percentage by mass 3:10:6: weighing liquorice, honeysuckle, bitter apricot kernels and rhizoma anemarrhenae, adding the liquorice, the honeysuckle, the bitter apricot kernels and the rhizoma anemarrhenae into water with the temperature of 50-60 ℃, and soaking for 2-4 hours, wherein the weight ratio of the material liquid to the material liquid is 1: 4-6, heating to 80-90 ℃ for first boiling for 1-3 h, adding the mixed crushed material obtained in the step S1 and water at 80-90 ℃ in the boiling process, and uniformly stirring, wherein the weight ratio of the mixed crushed material to the water is 1: 3-5, standing for 2-4 h after the boiling is finished, heating to 90-95 ℃ for second boiling for 2-4 h, cooling and filtering to obtain filtrate 1;
s3, mixing the following components in percentage by mass 3:10:10, weighing and crushing the ephedra, the forsythia and the scutellaria baicalensis, adding the crushed ephedra, the forsythia and the scutellaria baicalensis into water with the temperature of 60-80 ℃ for soaking for 2-4 h, wherein the weight ratio of feed liquid is 1:6 to 8, heating to 90 to 95 ℃, decocting for 4 to 6 hours, filtering, adding water, repeatedly decocting for 2 to 3 times, and combining the filtrate to obtain a filtrate 2;
s4, respectively concentrating the filtrate 1 and the filtrate 2 under reduced pressure, wherein the concentration conditions are that the temperature is 65-75 ℃, the pressure is-0.02-0.04 MPa, and the concentration is carried out until the relative density is about 1.10-1.21, so as to obtain clear paste 1 and clear paste 2, adding mannitol into the clear paste 1, uniformly mixing, refrigerating at 10-20 ℃ for 30-40 min, and standing the clear paste 2 at normal temperature for 30-40 min;
s5, mixing the clear paste 1 and the clear paste 2, stirring for 10-15 min, preheating the mixture by hot air at 25-35 ℃, and spray-drying under the conditions that the temperature is 60-70 ℃, the spraying speed is 1-2L of clear paste/min, the air inlet temperature is 140-160 ℃, and the air flow is 4000-5000 m 3 The air outlet temperature is 80-90 ℃ to obtain clear paste powder, sodium cyclamate powder is added, and granules are obtained after uniform mixing and granulation; the weight parts of clear paste 1, clear paste 2, mannitol and sodium cyclamate powder are 18-24 parts of clear paste 1, 4-10 parts of clear paste 2, 1.5-2.0 parts of mannitol and 1.2-1.7 parts of sodium cyclamate powder;
s6, drying the obtained particles by hot air at the temperature of 70-90 ℃ for 50-70 min, and uniformly mixing to obtain the finished product.
Compared with the prior art, the invention has the beneficial effects that: (1) According to the invention, the auxiliary materials are mannitol and sodium cyclamate for sweet taste adjustment, and mannitol and the clear paste 1 are mixed and combined for long-time refrigeration treatment, so that the clear paste is promoted to be solidified, mannitol molecules can be uniformly distributed in the clear paste, the taste of the prepared particles is sweet, the moisture in the clear paste can be stably adjusted, the defect of non-uniformity of clear paste powder granulation particles can be overcome, and the particles can be more uniformly and stably formed;
(2) When the traditional Chinese medicine is extracted, hot water is added and then heated, so that the heat movement is accelerated in the process that the temperature of water molecules in the hot water is rapidly increased, the heat circulation of the solution is promoted, and the release of traditional Chinese medicine components is facilitated; adding the pulverized materials of gypsum, radix isatidis, radix ophiopogonis and herba houttuyniae in the process of decocting the liquorice, the honeysuckle, the bitter apricot seeds and the rhizoma anemarrhenae, continuously decocting to enable the eight traditional Chinese medicine components to interact, pulverizing the ephedra, the fructus forsythiae and the scutellaria baicalensis, and decocting separately, which is beneficial to improving the content of effective components; the invention divides the traditional Chinese medicines into parts, adopts the modes of hot water soaking, temperature rising and boiling to carry out water extraction, further improves the effective components, accelerates the recovery time of disease healing, and has stable product quality;
(3) The invention adopts the respective preparation of the clear paste, the preheating is carried out before the spray drying, the viscosity of the clear paste is reduced, the mixing with auxiliary materials is easy, the stability of the product quality is improved, simultaneously, the prepared granules have good fluidity and high stability, the detection of the contents of ephedrine, phillyrin and baicalin is not influenced, and the product meets the quality standard.
Detailed Description
In order to better understand the technical content of the invention, specific examples are provided below to further illustrate the invention.
The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.
The materials, reagents and the like used in the examples of the present invention can be obtained commercially without specific description.
Example 1
A preparation method of the infantile lung-heat cough and asthma granule comprises the following traditional Chinese medicinal materials by weight:
s1 comprises 24 parts by mass: 10:10: weighing 2400g of gypsum, 1000g of radix isatidis, 1000g of radix ophiopogonis and 1000g of herba houttuyniae, crushing, and sieving by a 70-mesh sieve to obtain a mixed crushed substance;
s2, mixing the following components in percentage by mass 3:10:6:10, weighing 300g of liquorice, 1000g of honeysuckle, 600g of bitter almond and 1000g of rhizoma anemarrhenae, adding 11600g of 50 ℃ water, soaking for 2h, heating to 80 ℃ for first decoction for 1h, adding 16200g of the mixed crushed material obtained in the step S1 and 80 ℃ water in the decoction process, uniformly stirring, standing for 2h after the decoction is finished, heating to 90 ℃ for second decoction for 2h, cooling, and filtering to obtain a filtrate 1;
s3, mixing the following components in percentage by mass 3:10:10, weighing 300g of ephedra, 1000g of forsythia and 1000g of scutellaria baicalensis, crushing, adding 13800g of water at 60 ℃, standing for 2h, heating to 90 ℃, decocting for 4h, filtering, adding water, repeatedly decocting for 2 times, and combining the filtrates to obtain a filtrate 2;
s4, respectively concentrating the filtrate 1 and the filtrate 2 under reduced pressure at 65 ℃ and 0.04MPa until the relative density is about 1.21 to obtain fluid extract 1 and fluid extract 2, weighing 2700g of the fluid extract 1, adding 225g of mannitol, uniformly mixing, refrigerating at 10 ℃ for 30min, weighing 600g of the fluid extract 2, and standing at normal temperature for 30min;
s5, mixing 2700g of clear paste 1 and 225g of clear paste 2, stirring for 12min, preheating with hot air at 25 ℃, and spray drying under the conditions of 60 ℃, spraying speed of 1L of clear paste/min, air inlet temperature of 140 ℃, and air flow rate of 4000m 3 The air outlet temperature is 80 ℃ to obtain clear paste powder, 180g of sodium cyclamate powder is added, and granules are obtained after uniform mixing and granulation;
s6, drying the obtained particles by hot air at the temperature of 70 ℃ for 50min, and uniformly mixing to obtain the finished product.
Example 2
A preparation method of a particle for treating cough and asthma caused by lung heat of children comprises the following steps:
s1 comprises 24 parts by mass: 10:10: weighing 2400g of gypsum, 1000g of radix isatidis, 1000g of radix ophiopogonis and 1000g of herba houttuyniae, crushing, and sieving by a 70-mesh sieve to obtain a mixed crushed substance;
s2, mixing the following components in percentage by mass 3:10:6:10, weighing 300g of liquorice, 1000g of honeysuckle, 600g of bitter apricot seed and 1000g of rhizoma anemarrhenae, adding 17400g of water at 60 ℃ to soak for 4h, heating to 90 ℃ to perform first decoction for 2h, adding 27000g of the mixed crushed material obtained in the step S1 and the water at 90 ℃ in the decoction process, uniformly stirring, standing for 4h after the decoction is completed, heating to 95 ℃ to perform second decoction for 4h, cooling, and filtering to obtain filtrate 1;
s3, mixing the following components in percentage by mass 3:10:10, weighing 300g of ephedra, 1000g of forsythia and 1000g of scutellaria baicalensis, crushing, adding 18400g of water with the temperature of 80 ℃, standing for 4h, heating to 95 ℃, decocting for 6h, filtering, adding water, repeatedly decocting for 2 times, and combining the filtrates to obtain a filtrate 2;
s4, respectively concentrating the filtrate 1 and the filtrate 2 under reduced pressure, wherein the concentration conditions are that the temperature is 65-75 ℃, the pressure is-0.02-0.04 MPa, and the concentration is carried out until the relative density is about 1.10, so as to obtain clear paste 1 and clear paste 2, weighing 3600g of the clear paste 1, adding 300g of mannitol, uniformly mixing, refrigerating at 20 ℃ for 40min, weighing 1500g of the clear paste 2, and standing at normal temperature for 40min;
s5 mixing fluid extract 1 (3600 g) and fluid extract 2 (1500 g), stirring for 12min, preheating with hot air at 35 deg.C, spray drying at 70 deg.C, spray speed of 1L/min, air inlet temperature of 160 deg.C, and air flowAn amount of 5000m 3 H, the air outlet temperature is 90 ℃, clear paste powder is obtained, 255g of sodium cyclamate powder is added, and granules are obtained by uniformly mixing and granulating;
s6, drying the obtained particles by hot air at the temperature of 90 ℃ for 70min, and uniformly mixing to obtain a finished product.
Example 3
A preparation method of a particle for treating cough and asthma caused by lung heat of children comprises the following steps:
s1 comprises 24 parts by mass: 10:10: weighing 2400g of gypsum, 1000g of radix isatidis, 1000g of radix ophiopogonis and 1000g of herba houttuyniae, crushing, and sieving by a 70-mesh sieve to obtain a mixed crushed substance;
s2, mixing the following components in percentage by mass 3:10:6:10, weighing 300g of liquorice, 1000g of honeysuckle, 600g of bitter apricot seed and 1000g of rhizoma anemarrhenae, adding 14500g of water with the temperature of 55 ℃, soaking for 4h, heating to 80 ℃ for first decoction for 3h, adding 21600g of the mixed crushed material obtained in the step S1 and water with the temperature of 85 ℃ in the decocting process, uniformly stirring, standing for 3h after the decoction is finished, heating to 90 ℃ for second decoction for 3h, cooling, and filtering to obtain filtrate 1;
s3, mixing the following components in percentage by mass 3:10:10, weighing 300g of ephedra, 1000g of forsythia and 1000g of scutellaria baicalensis, crushing, adding 18400g of water at 80 ℃, standing for 3h, heating to 92 ℃, decocting for 6h, filtering, adding water, decocting repeatedly for 3 times, and combining the filtrates to obtain a filtrate 2;
s4, respectively concentrating the filtrate 1 and the filtrate 2 under reduced pressure under the concentration condition that the temperature is 75 ℃ and the pressure is 0.02MPa until the relative density is about 1.10 to obtain a fluid extract 1 and a fluid extract 2, weighing 3300g of the fluid extract 1, adding 255g of mannitol, uniformly mixing, refrigerating at 20 ℃ for 35min, weighing 1050g of the fluid extract 2, and standing at normal temperature for 35min;
s5, mixing 3300g of clear paste 1 and 1050g of clear paste 2, stirring for 12min, preheating with hot air at 35 ℃, and spray drying under the conditions of 70 ℃, spraying speed of 1L of clear paste/min, air inlet temperature of 160 ℃, and air flow rate of 5000m 3 The air outlet temperature is 90 ℃ to obtain clear paste powder, 210g of sodium cyclamate powder is added, and granules are obtained after uniform mixing and granulation;
s6, drying the obtained particles by hot air at the temperature of 90 ℃ for 70min, and uniformly mixing to obtain a finished product.
Example 4
A preparation method of the infantile lung-heat cough and asthma particle comprises the following steps:
s1 comprises 24 parts by mass: 10:10: weighing 2400g of gypsum, 1000g of radix isatidis, 1000g of radix ophiopogonis and 1000g of herba houttuyniae, crushing, and sieving by a 60-80-mesh sieve to obtain a mixed crushed substance;
s2, mixing the following components in percentage by mass 3:10:6:10, weighing 300g of liquorice, 1000g of honeysuckle, 600g of bitter apricot seeds and 1000g of rhizoma anemarrhenae, adding 14500g of 55 ℃ water, soaking for 3h, heating to 85 ℃ for first decoction for 2.5h, adding 21600g of the mixed crushed material obtained in the step S1 and 85 ℃ water in the decoction process, uniformly stirring, standing for 3h after the decoction is finished, heating to 95 ℃ for second decoction for 3.5h, cooling, and filtering to obtain a filtrate 1;
s3, mixing the following components in percentage by mass 3:10:10, weighing 300g of ephedra, 1000g of forsythia and 1000g of scutellaria baicalensis, crushing, adding 18400g of water with the temperature of 70 ℃, standing for 3h, heating to 92 ℃, decocting for 6h, filtering, adding water, repeatedly decocting for 3 times, and combining the filtrates to obtain a filtrate 2;
s4, respectively concentrating the filtrate 1 and the filtrate 2 under reduced pressure at 70 ℃ under-0.02 MPa until the relative density is about 1.17 to obtain fluid extract 1 and fluid extract 2, weighing 3300g of fluid extract 1, adding 255g of mannitol, mixing, refrigerating at 15 ℃ for 38min, weighing 1050g of fluid extract 2, and standing at normal temperature for 38min;
s5, mixing 3300g of the clear paste 1 and 255g of the clear paste 2, stirring for 12min, preheating by hot air at 30 ℃, and spray-drying under the conditions of 65 ℃, spraying speed of 1.5L of clear paste/min, air inlet temperature of 150 ℃, air flow rate of 4500m 3 H, blowing air at the temperature of 85 ℃ to obtain clear paste powder, adding 210g of sodium cyclamate powder, uniformly mixing and granulating to obtain granules;
s6, drying the obtained particles by hot air at the temperature of 80 ℃ for 60min, and uniformly mixing to obtain the finished product.
Comparative example 1
The preparation method of the infantile lung-heat cough and asthma granule according to the embodiment 4 is characterized by comprising the following steps: in the steps S1 and S2, the mass ratio of the components is 24:10:10:10, weighing 2400g of gypsum, 1000g of isatis root, 1000g of radix ophiopogonis and 1000g of houttuynia cordata, crushing to obtain crushed materials, and mixing the crushed materials in a mass ratio of 3:10:6:10, weighing 300g of liquorice, 1000g of honeysuckle, 600g of bitter apricot seeds and 1000g of rhizoma anemarrhenae, adding the crushed material obtained in the step S1 and 31600g of water with the temperature of 85 ℃, uniformly stirring, heating to 95 ℃, decocting for 6 hours, cooling and filtering to obtain filtrate 1.
Comparative example 2
The preparation method of the infantile lung-heat cough and asthma granule according to the embodiment 4 is characterized by comprising the following steps: in the step S4, the filtrate 1 and the filtrate 2 are mixed, decompressed and concentrated to obtain clear paste, and 210g of mannitol is added.
Comparative example 3
The preparation method of the infantile lung-heat cough and asthma granule according to the embodiment 4 is characterized by comprising the following steps: in the step S4, refrigeration is not performed.
Comparative example 4
The preparation method of the infantile lung-heat cough and asthma granule according to the embodiment 4 is characterized by comprising the following steps: and in the step S4, refrigerating at 5 ℃ for 20min.
Comparative example 5
The preparation method of the infantile lung-heat cough and asthma granule according to the embodiment 4 is characterized by comprising the following steps: in the step S5, hot air preheating is not carried out.
1. Product inspection results
(1) The particle for treating lung heat cough and asthma of children prepared in the embodiments 1 to 4 and the comparative examples 1 to 5 is subjected to detection of the particle size, the dissolubility, the content of ephedrine, amygdalin and baicalin according to the 'Chinese pharmacopoeia' 2020 edition, and the detection results are shown in table 1.
TABLE 1
Figure BDA0003115185410000071
Experiments show that the infantile lung heat cough and asthma granules prepared in the embodiments 1-4 have the ephedrine content of more than 0.55mg/g, the phillyrin content of more than 0.27mg/g, the baicalin content of more than 12.44mg/g and the granularity of 3.5-5.5 percent, are completely dissolved within 1min, are slightly turbid, have no coke breeze, are brown granules, are fresh and sweet, have stable product quality and meet the quality standard.
The ephedrine, phillyrin and baicalin contents of the comparative example 1 are lower; comparative example 2 the clear paste is not separately concentrated, the prepared granules are slightly turbid, and the granularity is larger; comparative example 3, which has a slightly sweet taste and no fresh sweet taste, shows that sweet molecules of mannitol can be left in the clear paste after long-time refrigeration; comparative example 4 adopts low temperature refrigeration, the taste is slightly sweet, but the content of ephedrine and phillyrin is low, the lower temperature influences the internal structure shape of the clear paste, the preparation and the forming are not easy, the particle size is large, and the yield is low; comparative example 5 has a poor granularity, the hot air preheating further softens the interior of the clear paste, the hot air accelerates intermolecular movement, reduces the viscosity of the clear paste, ensures that the spray-dried particles are uniform and are easy to mix with auxiliary materials to form a good granularity.
(2) Stability study: the infantile lung-heat cough and asthma granules prepared in examples 1 to 4 and comparative examples 1 to 5 were subjected to thin-layer chromatography (ephedra, forsythia, scutellaria) and moisture (%) detection and ephedrine content detection according to the Chinese pharmacopoeia 2020 edition for 6 months, and the detection results are shown in table 2.
TABLE 2
Figure BDA0003115185410000081
Experimental results show that the particles for treating lung-heat cough and asthma of children prepared in the embodiments 1-4 of the invention meet the product quality regulations by thin-layer identification of ephedra, forsythia and scutellaria, the water content is between 1.59-1.68%, the ephedrine content is above 0.51mg/g, and the particles have good stability.
Comparative example 1 thin layer identification of spot blur of herba Ephedrae, fructus forsythiae, and Scutellariae radix; the scutellaria baicalensis of comparative example 2 is blurred; comparative example 3 the particles are more stable; spots of the ephedra, the forsythia and the scutellaria baicalensis of the comparative example 4 are blurred; comparative example 5 has a higher water content, a higher reduction in ephedrine content, and a lower granule stability.
2. Therapeutic effects
(1) Data: the 42 children were randomized into 2 groups. Observation group (n = 21) 12 men, 9 women, age 3-7 years; control group (n = 21) 14 men and 7 women, aged 3-8 years. The general data of sex, age, course of disease, etc. of two groups of children patients are statistically processed, and the difference has no statistical significance (P is more than 0.05), and has comparability;
(2) Diagnostic criteria: referring to the diagnosis standard of pneumonia, asthma and cough in the 'traditional Chinese medicine disease diagnosis curative effect standard', the clinical manifestations of the pneumonia, asthma and cough are fever, cough, expectoration, shortness of breath, auscultation with special sounds such as blister sound, asthma and singing sound, and the increase of the number of leucocytes is detected by blood routine; patients with drug allergy were excluded;
(3) The treatment method comprises the following steps: patients in the control group were treated with commercially available infantile lung heat cough and asthma granule (sunflower pharmaceutical industry, national standard Z30205235, specification 3g × 6 bags/box); the experimental group takes the particles for treating the cough and asthma of the lung heat of the children prepared in the embodiment 4 of the invention; the composition is taken after meals every day, and during treatment, people are careful not to catch cold, and the composition is regularly worked and stopped, and the diet is light. Children under 3 years old, 3 g/time and 3 times/d; 3-7 years old children, 3 g/time and 4 times/d; children over 7 years old, 6 g/time, 3 times/d; one week is a treatment course, and the recovery condition of the patient is observed every day;
(4) Evaluation indexes are as follows: observing the treatment conditions of the two groups of patients, and recording the days when the fever of the patients subsides, the days when the cough disappears, the days when the gasping disappears and the adverse reactions such as vomit, diarrhea, stomach discomfort and the like, wherein the treatment conditions are shown in a table 3;
(5) The data processing method comprises the following steps: significance analysis was performed using SPSS 17.0 software.
TABLE 3
Figure BDA0003115185410000091
Remarking: * Denotes p <0.05
The treatment results show that the fever resolution time and the cough resolution time of the experimental group are shorter than those of the control group, and the statistical difference (p is less than 0.05) exists between the two groups.
In conclusion, the invention controls the time and temperature of soaking and boiling the traditional Chinese medicine in hot water, the mannitol is added into the clear paste, and the way of refrigerating for a long time and preheating clear paste powder by hot air is adopted, so that the prepared granules for treating the cough and asthma with the lung heat in the children have fresh and sweet taste, good stability, high content of effective components and good curative effect, and the recovery time of disease cure is accelerated.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (1)

1. A preparation method of the infantile lung-heat cough and asthma particle is characterized in that: the preparation method comprises the following steps:
step S1: pulverizing gypsum, radix isatidis, radix ophiopogonis and herba houttuyniae, and sieving by 60-80 meshes to obtain a mixed pulverized material;
step S2: adding liquorice, honeysuckle, bitter apricot kernel and rhizoma anemarrhenae into water with the temperature of 50-60 ℃ to soak for 2-4 h, wherein the weight ratio of the material liquid to the material liquid is 1:4~6; heating to 80-90 ℃, decocting for 1-3 hours for the first time, adding the mixed crushed material obtained in the step S1 and water at 80-90 ℃ in the decocting process, and uniformly stirring, wherein the weight ratio of the mixed crushed material to the water is 1:3~5, standing for 2 to 4 hours after the boiling is finished, heating to 90 to 95 ℃, boiling for 2 to 4 hours for the second time, cooling, and filtering to obtain a filtrate 1;
the mass ratio of the gypsum to the radix isatidis to the radix ophiopogonis to the houttuynia cordata to the liquorice to the honeysuckle to the bitter apricot kernel to the rhizoma anemarrhenae is 24:10:10:10:3:10:6:10;
and step S3: pulverizing ephedra, fructus forsythiae and scutellaria baicalensis, adding the pulverized ephedra, fructus forsythiae and scutellaria baicalensis into water at the temperature of 60-80 ℃, and soaking for 2-4 h, wherein the weight ratio of the feed liquid is 1:6~8; heating to 90-95 ℃, decocting, filtering, adding water, decocting repeatedly for 2-3 times, wherein the decocting time is 4-6 h each time, and combining the filtrates to obtain a filtrate 2;
the mass ratio of the ephedra, the forsythia and the scutellaria is 3:10:10;
and step S4: respectively concentrating the filtrate 1 and the filtrate 2 under reduced pressure, concentrating under the concentration condition that the temperature is 65 to 75 ℃ and the pressure is-0.02 to 0.04MPa until the relative density is 1.10 to 1.21 to obtain a fluid extract 1 and a fluid extract 2, adding mannitol into the fluid extract 1, uniformly mixing, refrigerating at the temperature of 10 to 20 ℃ for 30 to 40min, and standing the fluid extract 2 at the normal temperature for 30 to 40min;
step S5: mixing the clear paste 1 and the clear paste 2, stirring for 10 to 15min, preheating by hot air at 25 to 35 ℃, spray drying to obtain clear paste powder, adding sodium cyclamate powder, mixing uniformly and granulating to obtain particles; the spray drying conditions are that the temperature is 60 to 70 ℃, the spray speed is 1 to 2L clear paste/min, the air inlet temperature is 140 to 160 ℃, and the air flow is 4000 to 5000m 3 The air outlet temperature is 80 to 90 ℃;
the weight parts of the clear paste 1, the clear paste 2, the mannitol and the sodium cyclamate powder are 18 to 24 parts of clear paste 1, 4 to 10 parts of clear paste 2, 1.5 to 2.0 parts of mannitol and 1.2 to 1.7 parts of sodium cyclamate powder;
step S6: and (3) drying the obtained particles by hot air at the temperature of 70-90 ℃ for 50-70min, and mixing uniformly to obtain a finished product.
CN202110661152.6A 2021-06-15 2021-06-15 Preparation method of infantile lung-heat cough and asthma granules Active CN113384650B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110661152.6A CN113384650B (en) 2021-06-15 2021-06-15 Preparation method of infantile lung-heat cough and asthma granules

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202110661152.6A CN113384650B (en) 2021-06-15 2021-06-15 Preparation method of infantile lung-heat cough and asthma granules

Publications (2)

Publication Number Publication Date
CN113384650A CN113384650A (en) 2021-09-14
CN113384650B true CN113384650B (en) 2022-10-04

Family

ID=77621075

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202110661152.6A Active CN113384650B (en) 2021-06-15 2021-06-15 Preparation method of infantile lung-heat cough and asthma granules

Country Status (1)

Country Link
CN (1) CN113384650B (en)

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108553578A (en) * 2018-05-30 2018-09-21 海南葫芦娃药业集团股份有限公司 A kind of preparation method of 4 grams of dresses granules for curing infantile lung pathogenic heat and cough and asthma

Also Published As

Publication number Publication date
CN113384650A (en) 2021-09-14

Similar Documents

Publication Publication Date Title
CN101822697B (en) Preparation method of traditional Chinese medicine ultrafine formula particles
CN107050304A (en) A kind of preparation method of the brave fruit Chinese herbal granules of the rock of Sugarless type two
CN112516219B (en) Preparation process of traditional Chinese medicine granules for treating systemic lupus erythematosus
CN113384650B (en) Preparation method of infantile lung-heat cough and asthma granules
CN108815364B (en) Probiotic fermented traditional Chinese medicine preparation for treating constipation of pigs and preparation method thereof
WO2023109574A1 (en) Traditional chinese medicine composition for treating thyroid cancer and preparation method therefor
CN113599471A (en) Traditional Chinese medicine granules for primary lung cancer and production process thereof
WO2021078087A1 (en) Traditional chinese medicine pill realizing targeted release, and preparation method therefor
CN111991358B (en) Pseudo-ginseng powder formula particle and preparation method thereof
CN109172729B (en) Lung-clearing paste and preparation method thereof
CN108607057B (en) Children&#39;s Malong cough and asthma relieving granules and preparation method thereof
CN111588750A (en) Preparation method of traditional Chinese medicine granules for treating wind-heat type common cold of pigs
CN113350300B (en) 3D printing traditional Chinese medicine effervescent tablet and preparation method thereof
CN105213806A (en) A kind ofly treat pharmaceutical composition of gynecological bleeding disease and preparation method thereof
CN103990091A (en) Pharmaceutical composition for treating cold and fever and preparation method thereof
CN1295856A (en) Syrup and granules for treating laryngopharyngitis and preparation process thereof
CN112138105B (en) Traditional Chinese medicine composition for treating bronchiectasis lung-spleen qi deficiency and phlegm-damp lung blocking syndrome and application thereof
CN109985159A (en) A kind of infantile lung heat cough and asthma oral gel of fruity and preparation method thereof
CN113018351B (en) Pharmaceutical composition, pharmaceutical preparation, and preparation method and application thereof
CN113181259B (en) Children&#39;s astragalus-ginseng cold-treating granule and its prepn
CN114632126B (en) Traditional Chinese medicine combination medicine for treating functional constipation and preparation method and application thereof
CN115869375B (en) Traditional Chinese medicine composition for clearing heat and dispelling wind as well as preparation method and application thereof
CN109157601B (en) Phlegm-reducing asthma-relieving ointment and preparation method thereof
CN100518758C (en) Shenkun blood nourishing granule and its prepn. method
CN116509970A (en) Preparation method of Marsdenia tenacissima tablet

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant