CN107854671A - 阿那日系列蒙药胃内漂浮缓释制剂及其制备方法 - Google Patents

阿那日系列蒙药胃内漂浮缓释制剂及其制备方法 Download PDF

Info

Publication number
CN107854671A
CN107854671A CN201711118638.5A CN201711118638A CN107854671A CN 107854671 A CN107854671 A CN 107854671A CN 201711118638 A CN201711118638 A CN 201711118638A CN 107854671 A CN107854671 A CN 107854671A
Authority
CN
China
Prior art keywords
release
preparation
anaesthetic
auxiliary material
medicine
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.)
Pending
Application number
CN201711118638.5A
Other languages
English (en)
Inventor
张慧文
宋晓玲
梁越
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to CN201711118638.5A priority Critical patent/CN107854671A/zh
Publication of CN107854671A publication Critical patent/CN107854671A/zh
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016Disaccharides, e.g. lactose, lactulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/02Ammonia; Compounds thereof
    • 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
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10Carbonates; Bicarbonates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14Blood; Artificial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/612Crustaceans, e.g. crabs, lobsters, shrimps, krill or crayfish; Barnacles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/618Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • 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
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
    • 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)
    • 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)
    • A61K36/22Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
    • 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)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285Aucklandia
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286Carthamus (distaff thistle)
    • 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
    • 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)
    • A61K36/36Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • 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)
    • A61K36/42Cucurbitaceae (Cucumber 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)
    • A61K36/45Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • 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
    • 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)
    • A61K36/49Fagaceae (Beech family), e.g. oak or chestnut
    • 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
    • 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)
    • A61K36/54Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • 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)
    • A61K36/57Magnoliaceae (Magnolia 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)
    • A61K36/58Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
    • 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)
    • A61K36/61Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • 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)
    • A61K36/62Nymphaeaceae (Water-lily 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)
    • A61K36/67Piperaceae (Pepper family), e.g. Jamaican pepper or kava
    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718Coptis (goldthread)
    • 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)
    • A61K36/74Rubiaceae (Madder family)
    • A61K36/744Gardenia
    • 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)
    • A61K36/79Schisandraceae (Schisandra 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)
    • A61K36/80Scrophulariaceae (Figwort 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)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • 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)
    • A61K36/86Violaceae (Violet 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)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9064Amomum, e.g. round cardamom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Virology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Immunology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Insects & Arthropods (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

本发明涉及一种用于治疗胃病的阿那日系列蒙药胃内漂浮缓释制剂及其制备方法,属于药品制造技术领域,目前阿那日复方多为散剂,易吸湿、粘连、结块,服用剂量较大,味辛辣,顺应性差。本发明所述阿那日胃内漂浮缓释制剂包括主药和药用辅料,主药包括阿那日或其浸膏,缓释辅料用于构建药物的骨架结构、控制药物的溶出速度,常释辅料用于使药物漂浮、制剂成型;常释辅料包括助漂剂和/或填充剂和/或粘合剂和/或润滑剂。本发明利用定位缓释给药系统,其释药平稳持久,并可以持续漂浮,以实现胃内定位释药,提高阿那日口服时的生物利用度,并克服散剂剂量大、给药频繁的缺点,可掩盖药物的不良气味,提高患者的顺应性,达到更理想的治疗效果。

Description

阿那日系列蒙药胃内漂浮缓释制剂及其制备方法
技术领域
本发明涉及一种用于治疗胃病的口服药物,属于药品制造技术领域,具体地是阿那日系列蒙药胃内漂浮缓释制剂及其制备方法。
背景技术
阿那日系列蒙药(以下简称为阿那日)是蒙药经典临床验方,在《四部医典•后续部》、《金匮方释》、《蒙医成方选》和《高世格梅林方》等蒙医著作中均有记载,以阿那日-4为基础的阿那日系列蒙药包括阿那日-5、阿那日-6、阿那日-7、阿那日-8、阿那日-9、阿那日-10、阿那日-11、阿那日-12、阿那日-13、阿那日-14、阿那日-15、阿那日-17、阿那日-20、阿那日-24和阿那日-25等,均可用于祛“巴达干协日”,具有开胃、助消化功能,主治消化不良、灰白“巴达干赫依”、胃呆、胃火衰败等症,对消化不良、胃溃疡、胃酸呕吐等病症临床疗效较好。
阿那日临床疗效确切,使用历史久远,具有研究价值,但是目前阿那日复方的使用剂型为散剂,存在以下问题:
1、散剂药材粉末的比表面积大,在贮存过程中粉体易吸湿、粘连、结块,或药物活性成分易氧化和水解,丧失药效,这也是散剂多为现制现用的原因,使用不便;
2、散剂中药物活性成分并未得到富集,导致杂质含量高、服用剂量较大和服药不便等缺点;
3、由于阿那日中多味药材如荜茇、肉桂和干姜等,味辛辣,药物不良气味较大,降低了患者的顺应性;因此,落后的剂型在一定程度上限制了阿那日在临床上的应用。
为克服阿那日散剂上述缺点,本发明提出了阿那日胃内漂浮缓释制剂,该制剂能够使药物持久地滞留于胃部,增加药物的生物利用度,获得了预期的疗效,减小副作用;同时,阿那日胃内漂浮片便于携带、贮存,服用剂量减小,提高患者的顺应性。
发明内容
本发明的目的在于提供一种用于治疗胃病的阿那日系列蒙药胃内漂浮缓释制剂。
本发明的目的还在于提供上述阿那日系列蒙药胃内漂浮缓释制剂的制备方法。
为解决上述技术问题所采用的技术方案是:阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:
该阿那日胃内漂浮缓释制剂包括主药和药用辅料,主药与药用辅料的重量比为1:0.67-9;主药包括阿那日或其浸膏,药用辅料包括缓释辅料、常释辅料;缓释辅料用于构建药物的骨架结构、控制药物的溶出速度,常释辅料用于使药物漂浮、制剂成型;缓释辅料与常释辅料的重量比为:1:0.15-2.5。
所述缓释辅料阻滞药物释放速度,以一类高分子材料作为骨架材料,常释辅料包括助漂剂和/或填充剂和/或粘合剂和/或润滑剂;
所述骨架材料为羟丙基甲基纤维素、羟丙基纤维素、甲基纤维素、羟乙基纤维素、壳聚糖、卡波普、聚乙烯醇、硬脂酸、单硬脂酸甘油酯、鲸蜡醇、蜂蜡、十六醇、十八醇中的一种或多种;
所述助漂剂为碳酸钠、碳酸氢钠、轻质碳酸镁中的一种或多种;
所述填充剂为蔗糖、乳糖、淀粉、糊精、预胶化淀粉、微晶纤维素中的一种或多种;
所述粘合剂为无水乙醇或含一定体积乙醇的水溶液,乙醇的体积分数为50-100%;
所述润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇、十二烷基硫酸钠中的一种或多种。
所述骨架材料为羟丙基甲基纤维素和/或十八醇;
所述填充剂为微晶纤维素;
所述助漂剂为碳酸氢钠;
所述润滑剂为硬脂酸镁。
所述粘合剂优选85%的乙醇溶液。
优选主药与缓释辅料的重量比为1:1-3时,主药与常释辅料的重量比为1:0.5-2。
上述药用辅料的具体选择通过正交筛选实验及相关的验证性实验获得。
上述各药用辅料间的用药比例通过正交筛选实验及相关的验证性实验确定。
本发明提供的阿那日系列蒙药胃内漂浮缓释制剂,通过控制阿那日或其浸膏与特定药物辅料的比例,不仅可以使药物长时间滞留于胃部,而且可以通过缓释作用,极大地提高了生物利用度,从而减少药物的不良反应,更好地发挥阿那日的药理作用。
所述阿那日系列蒙药胃内漂浮缓释制剂,包括片剂、胶囊剂、微丸剂等,优选片剂。
所述阿那日胃内漂浮缓释制剂由以下方法制备而成:
将阿那日浸膏制粉与缓释辅料、填充剂按照等量递加法混合均匀,加入粘合剂制软材;软材过24目筛制颗粒,50℃-60℃烘箱干燥,过20目筛整粒后,加入助漂剂和润滑剂,混合均匀,压片,既得阿那日胃内漂浮缓释制剂,该制剂类型为片剂。
上述片剂的制备过程中,可将阿那日浸膏替换为阿那日散剂,也可以获得具有相同或相近漂浮特性的阿那日系列蒙药胃内漂浮缓释片剂。
所述阿那日浸膏的制备方法如下:
将阿那日药材粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取2-3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得阿那日浸膏;将阿那日浸膏粉碎过100目筛,既得阿那日浸膏粉。
该片剂可用常规湿法制粒压片方法制备,优选制备成骨架型片剂,即以羟丙基甲基纤维素、羟丙基纤维素、甲基纤维素、羟乙基纤维素、壳聚糖、卡波普、聚乙烯醇、硬脂酸、单硬脂酸甘油酯、鲸蜡醇、蜂蜡、十六醇、十八醇等中的一种或多种原料作为骨架,阿那日或阿那日浸膏包藏于骨架中。本发明提供的药物胃内滞留缓释片剂适合于每天给药2次,所述的药用辅料还包括其他本领域公知的填充剂、粘合剂、润滑剂等常用辅料。上述羟丙基甲基纤维素的粘度优选4000cPa.s。
本发明的有益效果是:
1、本发明利用定位缓释给药系统——胃内漂浮缓释制剂,其释药平稳持久,并可以持续漂浮,以实现胃内定位释药,提高阿那日口服时的生物利用度,并克服散剂剂量大、给药频繁的缺点,可掩盖药物的不良气味,提高患者的顺应性,达到更理想的治疗效果;
2、本发明阿那日胃内漂浮缓释片质量评价结果表明:所述缓释材料为羟丙甲纤维素和/或十八醇,常释辅料为碳酸氢钠、微晶纤维素时,制备的胃内漂浮缓释片硬度符合《中国药典》规定,外观光滑均匀,片剂具有较好的漂浮性能,起漂时间在3min之内,并持续漂浮可达12h;体外释放度考察,累计释放率-时间曲线反映的释药特性较好,12h药物释放可达90%以上,数据如下表,曲线如图1:溶出度曲线累积释放率;
3、本发明选用适合蒙药阿那日系列复方的有效部位和符合胃内漂浮制剂制备工艺要求的辅料进行胃内漂浮缓释制剂的制备,制备出的胃内漂浮缓释制剂能够实现定位释药,有效解决胃排空中的“全或无”问题,使药物较长时间停留胃部发挥治疗作用,还可以使药物缓慢持久释放,既减少日给药次数,又较好的控制药物浓度,避免峰谷效应,提高生物利用度。
附图说明
图1、溶出度曲线累积释放率(图中系列1-6为溶出度实验的实验批次)。
具体实施方式
实施例1:阿那日-4浸膏的制备
取处方药材石榴100g、肉桂皮100g、白豆蔻100g、荜拨100g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-4浸膏粉。
以下阿那日系列的制备方法与上述阿那日-4的制备方法完全相同。
实施例2:阿那日-5浸膏的制备
取处方药材石榴250g、肉桂15g、白豆蔻150g、荜茇100g、干姜100g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-5浸膏粉。
实施例3:阿那日-6浸膏的制备
取处方药材石榴100g、肉桂100g、白豆蔻100g、荜茇100g、干姜100g、光明盐100g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-6浸膏粉。
实施例4:阿那日-7浸膏的制备
取处方药材石榴100g、白豆蔻100g、肉桂100g、荜茇100g、土木香100g、芫荽子100g、光明盐100g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-7浸膏粉。
实施例5:阿那日-8浸膏的制备
取处方药材石榴40g、肉桂50g、白豆蔻50g、荜茇100g、干姜50g、光明盐50g,赤盐50g,白古月50g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-8浸膏粉。
实施例6:阿那日-9浸膏的制备
取处方药材石榴50g、肉桂10g、白豆蔻10g、荜茇10g、干姜20g、肉豆蔻10g、草果10g、白古月10g、蛇床子10g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-9浸膏粉。
实施例7:阿那日-10浸膏的制备
取处方药材石榴40g、肉桂5g、白豆蔻5g、干姜5g、荜茇5g、光明盐5g、槲寄生5g、香菜子5g、赤盐5g、五味子5g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-10浸膏粉。
实施例8:阿那日-11浸膏的制备
取处方药材石榴10g、肉桂10g、白豆蔻10g、荜茇10g、光明盐5g、诃子5g、红花5g、干姜5g、木香5g、肉豆蔻5g、丁香5g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-11浸膏粉。
实施例9:阿那日-12浸膏的制备
取处方药材石榴15g、肉桂10g、白豆蔻6g、荜茇14g、肉豆蔻10g、草果8g、干姜10g、黑种草子5g、诃子10g、紫硇砂7g、红花13g、赤盐11g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-12浸膏粉。
实施例10:阿那日-13浸膏的制备
取处方药材石榴100g、肉桂5g、荜茇5g、干姜10g、大托叶云实15g、蛇床子15g、雕粪10g、鹰粪10g、硇砂15g、铁线莲20g、小米辣20g、酸藤果5g、黑胡椒5g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-13浸膏粉。
实施例11:阿那日-14浸膏的制备
取处方药材石榴15g、肉桂9g、白豆蔻9g、荜茇6g、诃子6g、肉豆蔻6g、红花6g、青木香12g、栀子6g、光明盐6g、干姜9g、草果9g、芫荽子9g、寒水石30g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-14浸膏粉。
实施例12:阿那日-15浸膏的制备
取处方药材石榴20g、肉桂20g、白豆蔻20g、荜茇20g、紫硇砂20g、光明盐20g、赤盐20g、小米辣20g、木瓜20g、干姜20g、红花20g、香青兰20g、绿绒蒿20g、五灵脂20g、寒水石20g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-15浸膏粉。
实施例13:阿那日-17浸膏的制备
取处方药材石榴20g、肉桂20g、白豆蔻20g、荜茇20g、干姜20g、菥蓂子20g、地丁20g、芫荽子20g、黄连20g、瞿麦20g、五灵脂20g、翼首草20g、红花20g、栀子20g、香青兰20g、螃蟹20g、花苜蓿20g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-17浸膏粉。
实施例14:阿那日-20浸膏的制备
取处方药材石榴20g、肉桂20g、白豆蔻20g、荜茇20g、干姜20g、菥蓂子20g、香青兰20g、芫荽子20g、地丁20g、黄连20g、瞿麦20g、五灵脂20g、翼首草20g、红花20g、栀子20g、螃蟹20g、花苜蓿20g、芒果20g、蒲桃仁20g、大托叶云实20g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-20浸膏粉。
实施例15:阿那日-24浸膏的制备
取处方药材石榴20g、肉桂20g、白豆蔻20g、小米辣20g、荜茇20g、干姜20g、黑胡椒20g、照山白20g、草果20g、光明盐20g、赤盐20g、硇砂20g、酸藤果20g、芡实20g、铁线莲20g、诃子炭20g、石灰20g、红糖20g、五味子20g、葫芦子20g、茯苓20g、飞燕草20g、橡子20g、盘羊血20g、野牦牛血20g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-24浸膏粉。
实施例16:阿那日-25浸膏的制备
取处方药材石榴200g、丁香25g、紫硇砂25g、光明盐25g、红花25g、火硝25g、石灰华25g、贝齿25g、肉豆蔻25g、葫芦25g、肉桂25g、白豆蔻25g、草果25g、藏木香25g、生姜25g、荜茇25g、黑胡椒25g、赤盐25g、白胡椒25g、地丁25g、诃子25g、川楝子25g、栀子25g、胡黄连25g、木香25g粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得干浸膏,粉碎过100目筛,既得阿那日-25浸膏粉。
实施例17:胃内漂浮缓释片的制备:
将30g阿那日-4浸膏粉与40g羟丙甲纤维素、15g十八醇、20g微晶纤维素辅料分别过100目筛后,按照等量递加法混合均匀,加入适量85%乙醇溶液制软材,过24目筛制颗粒,50℃烘箱干燥,过20目筛整粒。在上述颗粒中加入3g碳酸氢钠及1g硬脂酸镁混合均匀,压片,既得。
所制备的阿那日-4胃内漂浮缓释片硬度为4.2kg,符合《中国药典》规定;外观光滑均匀,起漂时间为97s,并持续漂浮可达12h;药物累计释放率92.1%。
实施例18:转篮法体外释放度测定
用转篮法进行体外释放度测定。精密称取6片制备的阿那日-4胃内漂浮片,放入转速100r/min、温度(37±0.5)℃、以900ml盐酸溶液(0.1mol/L)为释放介质的转篮中,在第0.5、2、4、6、8、10、12h、24h分别取样5ml于离心管中,经0.45μm微孔滤膜滤过,同时补充5ml相同温度、相同体积的盐酸溶液。精密量取1.0ml盐酸(0.1mol/L)置于5ml容量瓶中,用甲醇定容作为空白对照。精密吸取1.0ml取出的样品,用甲醇定容至5ml容量瓶中,在254nm处测定其吸光度A值。认为每组12h的体外释放度为100%释放,绘制如图1所示的0-12h溶出度累积释放度曲线。
分别量取供试品溶液、对照品溶液,用紫外分光光度法测定,在254nm处测其吸光度A值,回归方程:y=32.643x-0.0529,相关系数R2=0.9984,表明对照品在8-24μg/ml范围内线性关系良好。
按外标法以峰面积计算每片在不同时间点的释放率。结果表明,本发明提供的制剂1小时的累积释放率均为20-70%,12小时的累计释放率均大于90%。从上述数据可以看出,1小时的释放率较大,从而起效较快,而且可以继续通过缓释作用来发挥阿那日的药理作用。
最后所应说明的是,以上具体实施方式仅用以说明本发明创造的技术方案而非限制,尽管参照实例对本发明创造进行了详细说明,本领域的普通技术人员应当理解,可以对本发明创造的技术方案进行修改或者等同替换,而不脱离本发明创造技术方案的精神和范围,其均应涵盖在本发明创造的权利要求范围当中。

Claims (8)

1.阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:
该阿那日胃内漂浮缓释制剂包括主药和药用辅料,主药与药用辅料的重量比为1:0.67-9;主药包括阿那日或其浸膏,药用辅料包括缓释辅料、常释辅料;缓释辅料用于构建药物的骨架结构、控制药物的溶出速度,常释辅料用于使药物漂浮、制剂成型;缓释辅料与常释辅料的重量比为:1:0.15-2.5。
2.根据权利要求1所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:所述缓释辅料阻滞药物释放速度,以一类高分子材料作为骨架材料,常释辅料包括助漂剂和/或填充剂和/或粘合剂和/或润滑剂;
所述骨架材料为羟丙基甲基纤维素、羟丙基纤维素、甲基纤维素、羟乙基纤维素、壳聚糖、卡波普、聚乙烯醇、硬脂酸、单硬脂酸甘油酯、鲸蜡醇、蜂蜡、十六醇、十八醇中的一种或多种;
所述助漂剂为碳酸钠、碳酸氢钠、轻质碳酸镁中的一种或多种;
所述填充剂为蔗糖、乳糖、淀粉、糊精、预胶化淀粉、微晶纤维素中的一种或多种;
所述粘合剂为无水乙醇或含一定体积乙醇的水溶液,乙醇的体积分数为50-100%;
所述润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇、十二烷基硫酸钠中的一种或多种。
3.根据权利要求2所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:
所述骨架材料为羟丙基甲基纤维素和/或十八醇;
所述填充剂为微晶纤维素;
所述助漂剂为碳酸氢钠;
所述润滑剂为硬脂酸镁。
4.根据权利要求3所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:所述粘合剂优选85%的乙醇溶液。
5.根据权利要求4所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:优选主药与缓释辅料的重量比为1:1-3时,主药与常释辅料的重量比为1:0.5-2。
6.根据权利要求1至5任一权利要求所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:所述阿那日系列蒙药胃内漂浮缓释制剂,包括片剂、胶囊剂、微丸剂。
7.根据权利要求6任一权利要求所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:所述阿那日胃内漂浮缓释制剂由以下方法制备而成:
将阿那日浸膏制粉与缓释辅料、填充剂按照等量递加法混合均匀,加入粘合剂制软材;软材过24目筛制颗粒,50℃-60℃烘箱干燥,过20目筛整粒后,加入助漂剂和润滑剂,混合均匀,压片,既得阿那日胃内漂浮缓释制剂,该制剂类型为片剂。
8.根据权利要求7所述的阿那日系列蒙药胃内漂浮缓释制剂,其特征在于:所述阿那日浸膏的制备方法如下:
将阿那日药材粉碎后,加入8-12倍体积的50%-90%乙醇,80℃-100℃加热回流提取2-3次,每次60-90min,提取液冷却至室温,抽滤、合并,旋蒸回收乙醇至无醇味,浓缩至密度为1.10的清膏,冷冻干燥12-24h,既得阿那日浸膏;将阿那日浸膏粉碎过100目筛,既得阿那日浸膏粉。
CN201711118638.5A 2017-11-14 2017-11-14 阿那日系列蒙药胃内漂浮缓释制剂及其制备方法 Pending CN107854671A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201711118638.5A CN107854671A (zh) 2017-11-14 2017-11-14 阿那日系列蒙药胃内漂浮缓释制剂及其制备方法

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201711118638.5A CN107854671A (zh) 2017-11-14 2017-11-14 阿那日系列蒙药胃内漂浮缓释制剂及其制备方法

Publications (1)

Publication Number Publication Date
CN107854671A true CN107854671A (zh) 2018-03-30

Family

ID=61701559

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201711118638.5A Pending CN107854671A (zh) 2017-11-14 2017-11-14 阿那日系列蒙药胃内漂浮缓释制剂及其制备方法

Country Status (1)

Country Link
CN (1) CN107854671A (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112294934A (zh) * 2020-11-12 2021-02-02 成都武侯甘露海藏医院有限公司 一种藏药六方石榴散组合物及其制备方法与应用
CN112999171A (zh) * 2021-03-26 2021-06-22 王伟 含纤维类蒙药粉配方颗粒及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101721417A (zh) * 2009-12-21 2010-06-09 深圳海王药业有限公司 一种治疗胃肠道恶性肿瘤的胃内滞留漂浮缓释片
CN106310071A (zh) * 2015-07-07 2017-01-11 山东金诃药物研究开发有限公司 一种六味安消胃漂浮片及其制备方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101721417A (zh) * 2009-12-21 2010-06-09 深圳海王药业有限公司 一种治疗胃肠道恶性肿瘤的胃内滞留漂浮缓释片
CN106310071A (zh) * 2015-07-07 2017-01-11 山东金诃药物研究开发有限公司 一种六味安消胃漂浮片及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
周旻昱等: "蒙药阿那日五味漂浮片提取工艺的研究", 《中国民族医药杂志》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112294934A (zh) * 2020-11-12 2021-02-02 成都武侯甘露海藏医院有限公司 一种藏药六方石榴散组合物及其制备方法与应用
CN112999171A (zh) * 2021-03-26 2021-06-22 王伟 含纤维类蒙药粉配方颗粒及其制备方法

Similar Documents

Publication Publication Date Title
CN102727680B (zh) 一种降血脂的中药及制备方法
CN101637561A (zh) 川贝枇杷药物组合物及其制备方法
CN103599215A (zh) 一种降糖药物
CN102362966A (zh) 川贝枇杷药物组合物及其制备方法
CN101007071A (zh) 治疗急、慢性肠、胃炎及细菌性痢疾的中药及其制备工艺
CN107854671A (zh) 阿那日系列蒙药胃内漂浮缓释制剂及其制备方法
CN1318058C (zh) 一种治疗乳腺增生疾病的浓缩丸制备方法
CN105362337B (zh) 一种具有清热散结功能的中药组合物、制剂及其制备方法
CN103599343A (zh) 一种治疗糖尿病的药物组合物及其制备方法和用途
CN101147767B (zh) 一种治疗痤疮的药物组合物胶囊剂的制备方法
CN103961455A (zh) 一种清热解毒的中药复方制剂及其制备方法
CN107997170B (zh) 一种具有降血脂功能的组合物及其制备方法
CN103816466A (zh) 一种治疗胸痹心痛的中药组合物及其制剂和制备方法
CN104474275A (zh) 一种用于治疗急慢性咽炎的中药组合物及其制剂的制备方法
CN100430083C (zh) 调经祛斑丸及制备方法
CN1883603B (zh) 治疗牙痛的中药复方制剂及其制备方法
CN100427075C (zh) 板蓝根软胶囊及其制备方法
CN100441209C (zh) 胃痛宁分散片制剂及其制备方法
CN1951494B (zh) 一种治疗外感风寒的中药复方制剂及其制备方法
CN101317950A (zh) 一种益气补血养心安神胶囊的制作方法
CN108066397A (zh) 药物组合物
CN1846721B (zh) 七叶神安口腔崩解片及其制备方法
CN107753551B (zh) 一种具有降血压功能的组合物及其制备方法
CN105853917B (zh) 一种治疗慢性咽炎的药物组合物及其制备方法和应用
CN104352974A (zh) 一种含朱砂莲的治疗糖尿病的中药组合物

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
RJ01 Rejection of invention patent application after publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20180330