CN112972402A - 一种含油脂蒙药粉配方颗粒及其制备方法 - Google Patents
一种含油脂蒙药粉配方颗粒及其制备方法 Download PDFInfo
- Publication number
- CN112972402A CN112972402A CN202110324317.0A CN202110324317A CN112972402A CN 112972402 A CN112972402 A CN 112972402A CN 202110324317 A CN202110324317 A CN 202110324317A CN 112972402 A CN112972402 A CN 112972402A
- Authority
- CN
- China
- Prior art keywords
- oil
- mongolian medicine
- containing mongolian
- powder
- calcium carbonate
- 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.)
- Granted
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/34—Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/48—Reproductive organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/583—Snakes; Lizards, e.g. chameleons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/60—Fish, e.g. seahorses; Fish eggs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/646—Arachnids, e.g. spiders, scorpions, ticks or mites
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/482—Cassia, e.g. golden shower tree
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/49—Fagaceae (Beech family), e.g. oak or chestnut
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/52—Juglandaceae (Walnut family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/533—Leonurus (motherwort)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/55—Linaceae (Flax family), e.g. Linum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/83—Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
- A61K36/835—Aquilaria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/85—Verbenaceae (Verbena family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9062—Alpinia, e.g. red ginger or galangal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Alternative & Traditional Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Biomedical Technology (AREA)
- Virology (AREA)
- Immunology (AREA)
- Insects & Arthropods (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Animal Husbandry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Hematology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Marine Sciences & Fisheries (AREA)
- Reproductive Health (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
本发明涉及蒙药制剂技术领域,提供了一种含油脂蒙药粉配方颗粒及其制备方法。本发明提供的含油脂蒙药粉配方颗粒由含油脂蒙药、碳酸钙和淀粉浆制备得到;本发明将含油脂蒙药粉碎后加入碳酸钙和淀粉浆,然后进行湿法制粒,得到含油脂蒙药粉配方颗粒。本发明将含油脂蒙药制备成配方颗粒,实现了对含油脂蒙药剂型的改良,解决了蒙药服用困难、易污染和变质的问题;本发明能够完全保留含油脂蒙药的传统属性和用药习性,全面提升含油脂蒙药的质量可控性和稳定性。
Description
技术领域
本发明涉及药物制剂技术领域,尤其涉及一种含油脂蒙药粉配方颗粒及其制备方法。
背景技术
蒙医药是世界和中国传统医药的重要组成部分,具有鲜明的蒙古民族文化特色,是历史悠久、理论完整、疗效可靠、具有独到色彩的传统医药体系,在我国民族医药文化中占有重要的位置,不仅为蒙古民族的繁衍生息和人类健康提供了医疗保障,也为社会进步做出了巨大的贡献。西医药面对很多现代病束手无策,在寻求解决方案的过程中,师法自然的理念重回大众视野,恰好自然的属性是蒙医药的先天基因。因此包括蒙医药在内的民族医药趁势而起,吸引到了大众的关注。
蒙药饮片的传统剂型为细粉,即将原药直接研磨后服用,服用极其不便,患者顺应性极差,且具有易受污染和变质等缺点,不能满足现代人注重生活质量的要求,市场认可度低,严重的制约着蒙医药的发展与应用。形成这些不足的根本原因是蒙药制剂和饮片处于较为原始状态,其生产工艺简单,科技含量低,同时因为其理论与医药方法独特,又不能简单效仿中药饮片的制备技术。中药在制备配方颗粒时需要先进行煎煮提纯,然后再利用所得浸膏制粒,并且制备配方颗粒时需要加入多种、大量的辅料,很容易造成辅料超标,而这种方法应用于蒙药中,会影响蒙药的药效,使得蒙医在临床上无法进行准确配方,影响治疗效果。
含油脂蒙药中油或脂的含量较多,粉碎后所得细粉的粘性大,物料的均匀性、润滑性、成型性、流动性均较差,制备成颗粒剂较困难。
发明内容
有鉴于此,本发明的目的在于提供一种含油脂蒙药粉配方颗粒及其制备方法。本发明将含油脂蒙药制备成配方颗粒,实现了对含油脂蒙药剂型的改良,解决了蒙药服用困难、易污染和变质的问题;并且本发明制备的含油脂蒙药粉配方颗粒辅料用量少,不会造成辅料超标。
为了实现上述发明目的,本发明提供以下技术方案:
一种含油脂蒙药粉配方颗粒,制备原料包括含油脂蒙药、碳酸钙和淀粉浆;所述含油脂蒙药、碳酸钙和淀粉浆的质量比为74~76:17~25:40~60;所述淀粉浆的质量浓度为8~12%;所述含油脂蒙药粉配方颗粒中含油脂蒙药的质量分数为74.7~75.1%。
优选的,所述淀粉浆的质量浓度为10%。
优选的,所述含油脂蒙药以含油脂蒙药原粉的形式使用,所述含油脂蒙药原粉的目数≤100目。
优选的,所述含油脂蒙药为丁香、大托叶云实、小蜀季、天仙子、牛心干、牛胆粉、牛蒡子、火麻仁、生草果仁、白巨胜、白芝麻、冬葵果、亚麻子、肉豆蔻、肉桂、全蝎、决明子、芥子、豆蔻、角茴香、沉香、驴血、苦杏仁、苘麻子、制木鳖、制牛鞭、制巴豆、制斑蝥、制蛤蚧、牦牛心、炒马钱子、炒牛角、炒决明子、炒波棱瓜子、波棱瓜子、荜茇、草果、荠菜、茺蔚子、砂仁、香旱芹、独活、核桃仁、益智仁、烘白花蛇、海马、菥蓂子、野牛心、野兔心、猪血、斑蝥、葶苈子、黑巨胜、黑芝麻、黑种草子、蓖麻子、蓖麻霜、蔓荆子、槟榔或橡子。
优选的,当所述含油脂蒙药的油含量≥5wt%时,所述含油脂蒙药和碳酸钙的质量比为75:20~23:40~60;
当所述蒙药的油含量大于等于2wt%且小于5wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~22:40~60;
当所述蒙药的油含量大于等于1wt%且小于2wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~20:40~60;
当所述蒙药的油含量小于1wt%时,所述含油脂蒙药和碳酸钙的质量比为75:18~19:40~60;
当所述蒙药的脂含量为1~2wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~20:40~60;
当所述蒙药的脂含量小于1wt%时,所述含油脂蒙药和碳酸钙的质量比为75:18~19:40~60。
优选的,所述含油脂蒙药粉配方颗粒的含水量≤9%;所述含油脂蒙药粉配方颗粒的休止角≤41°;所述含油脂蒙药粉配方颗粒中不通过一号筛与能通过五号筛的颗粒的总和≤15%。
本发明还提供了上述方案所述含油脂蒙药粉配方颗粒的制备方法,包括以下步骤:
将含油脂蒙药低温粉碎后过筛,得到含油脂蒙药原粉;所述低温粉碎的温度为-20~-40℃;
将所述含油脂蒙药原粉、碳酸钙和淀粉浆混合进行湿法制粒,将所得湿粒干燥,得到含油脂蒙药粉配方颗粒。
优选的,所述过筛为过100目筛,筛下物为含油脂蒙药原粉。
优选的,所述混合为:先将含油脂蒙药原粉和碳酸钙混合20~40min,然后加入淀粉浆进行混合。
优选的,所述湿法制粒所用筛网的目数为14~16目。
优选的,所述干燥的温度为30~40℃。
优选的,所述干燥后,还包括将所得干颗粒进行整粒;所述整粒用筛网的目数为18~20目。
本发明提供了一种含油脂蒙药粉配方颗粒,由含油脂蒙药、碳酸钙和淀粉浆制备得到;所述含油脂蒙药、碳酸钙和淀粉浆的质量比为74~76:17~25:40~60;所述含油脂蒙药粉配方颗粒中含油脂蒙药的质量分数为74.7~75.1%。本发明采用碳酸钙和淀粉浆为辅料将含油脂蒙药制备成配方颗粒,其中碳酸钙作为吸附剂,可以吸附油脂,降低物料的粘性,改善粉末的流动性和均匀性,淀粉浆做为粘合剂,有利于物料的成型,最终所得物料的物理性质符合湿法制粒的标准,物料流动性、成型性和颗粒出成率均符合生产工艺要求,且碳酸钙的性质稳定,对配方颗粒中的蒙药不会产生影响,能够提高配方颗粒稳定性,所得配方颗粒的CRH值高,不易吸湿。本发明实现了对蒙药剂型的改良,解决了蒙药服用困难、易污染和变质的问题,且配方颗粒组成成分简单,辅料用量少,不会出现辅料超标、影响药效的问题。
此外,本发明提供的含油脂蒙药粉配方颗粒具有统一的规格和剂型标准,可供蒙医临床配方使用,采用传统蒙药进行配方时,由于蒙药的形状大小不一致,以质量计配方不便,因而通常以药物体积计量,而本发明的配方颗粒具有统一的形状和剂型标准,使用本发明的配方颗粒剂进行配方时,可实现以重量计量,使药物剂量更加准确,打破了蒙医只能依靠医疗机构制粒的无奈局面,全面实现蒙药临证施药、因病组方、一人一方;在需要以汤剂形式服用时,可以将本发明提供的配方颗粒先配后煎,避免了中药配方颗粒缺失共煎而影响临床疗效的弊端。
本发明还提供了上述方案所述含油脂蒙药粉配方颗粒的制备方法。本发明直接将含油脂蒙药进行粉碎过筛,然后添加碳酸钙和淀粉浆,采用湿法制粒的方法制备成配方颗粒。本发明采用含油脂蒙药原粉制备配方颗粒,无需进行煎煮或提纯,能够完全保留含油脂蒙药的传统属性和用药习性,较大程度的保护挥发性成分,全面提升含油脂蒙药的质量可控性,保证含油脂蒙药的安全和有效性;并且本发明采用粉碎过筛后的含油脂蒙药原粉进行制粒,粉碎过筛后的含油脂蒙药原粉颗粒细小,在胃肠道中溶出度高,能够提高含油脂蒙药的生物利用度。此外,本发明采用的制备方法工艺流程简单,成本低,可以实现规模化生产,为蒙药全面实现产业化提供的可能,且制备成本低。
附图说明
图1为本发明含油脂蒙药粉配方颗粒(以肉豆蔻为例)的制备通用工艺流程图。
具体实施方式
本发明提供了一种含油脂蒙药粉配方颗粒,由含油脂蒙药、碳酸钙和淀粉浆制备得到;所述含油脂蒙药、碳酸钙和淀粉浆的质量比为74~76:17~25:40~60,优选为75:18~22:47~53,进一步优选为75:20:50;所述含油脂蒙药粉配方颗粒中含油脂蒙药的质量分数为74.7~75.1%,优选为75%。
在本发明中,所述淀粉浆的质量浓度优选为8~12%,更优选为10%。
在本发明中,所述含油脂蒙药以含油脂蒙药原粉的形式使用,所述含油脂蒙药原粉的目数优选≤100目,更优选≤120目。
在本发明中,所述含油脂蒙药为丁香、大托叶云实、小蜀季、天仙子、牛心干、牛胆粉、牛蒡子、火麻仁、生草果仁、白巨胜、白芝麻、冬葵果、亚麻子、肉豆蔻、肉桂、全蝎、决明子、芥子、豆蔻、角茴香、沉香、驴血、苦杏仁、苘麻子、制木鳖、制牛鞭、制巴豆、制斑蝥、制蛤蚧、牦牛心、炒马钱子、炒牛角、炒决明子、炒波棱瓜子、波棱瓜子、荜茇、草果、荠菜、茺蔚子、砂仁、香旱芹、独活、核桃仁、益智仁、烘白花蛇、海马、菥蓂子、野牛心、野兔心、猪血、斑蝥、葶苈子、黑巨胜、黑芝麻、黑种草子、蓖麻子、蓖麻霜、蔓荆子、槟榔或橡子;在本发明的具体实施例中,优选使用上述种类的含油脂蒙药的单味饮片(粉)为原料进行制粒。
在本发明中,根据油性成分和脂肪含量的不同,可将上述含油脂蒙药分为以下几类:
油含量≥5wt%的含油脂蒙药,包括肉豆蔻、豆蔻、制巴豆、制木鳖、白芝麻、波棱瓜子、亚麻子和蓖麻子;在本发明的具体实施例中,当所述蒙药的油性成分含量≥5wt%时,所述含油脂蒙药和碳酸钙的质量比优选为75:20~23:40~60,更优选为75:20~22:45~50;
油含量大于等于2wt%且小于5wt%的含油脂蒙药,包括草果粉、苘麻子、蓖麻霜、黑芝麻、芥子、生草果仁、火麻仁、荠菜和炒马钱子;在本发明的具体实施例中,当所述含油脂蒙药的油含量大于等于2wt%且小于5wt%时,所述含油脂蒙药和碳酸钙的质量比优选为75:19~22:40~60,更优选为75:20~21:45~50;
油含量大于等于1wt%且小于2wt%的含油脂蒙药,包括丁香、角茴香、天仙子、砂仁、荜茇、益智仁、香旱芹、沉香、肉桂和牛蒡子;在本发明的具体实施例中,当所述蒙药的油含量大于等于1wt%且小于2wt%时,所述含油脂蒙药和碳酸钙的质量比优选为75:19~20:40~60,更优选为75:20:45~50;
油含量小于1wt%的含油脂蒙药,包括决明子、炒决明子、菥蓂子、大托叶云实、蔓荆子、槟榔粉、小蜀季、橡子、黑种草子、冬葵果和黑巨胜;在本发明的具体实施例中,当所述蒙药的油含量小于1wt%时,所述含油脂蒙药和碳酸钙的质量比优选为75:18~19:40~60,更优选为75:19:50~60;
脂含量为1~2wt%的含油脂蒙药,包括牦牛心、牛心干、野兔心、制蛤蚧、猪血和驴血;在本发明的具体实施例中,当所述蒙药的脂含量为1~2wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~20:40~60,更优选为75:20:45~50;
脂含量小于1wt%的含油脂蒙药,包括牛胆、全蝎、制斑蝥、海马、制牛鞭和炒牛角。在本发明的具体实施例中,当所述蒙药的脂含量小于1wt%时,所述含油脂蒙药和碳酸钙的质量比为75:18~19:40~60,更优选为75:19:50~60。
在本发明中,所述含油脂蒙药中含有的油成分多为不饱和脂肪酸酯类化合物,脂成分多为饱和脂肪酸酯类化合物,饱和或不饱和脂肪酸酯类化合物的结构中含有羟基等极性基团,碳酸钙可与上述极性基团发生物理或化学吸附作用,从而降低物料的粘性,本发明根据含油脂蒙药中油脂含量的不同控制碳酸钙的用量,能够进一步保证物料的流动性和均匀性。
在本发明中,所述含油脂蒙药粉配方颗粒的含水量优选≤9%,更优选≤8%;所述含油脂蒙药粉配方颗粒的休止角优选≤41°,更优选≤40.6°;所述含油脂蒙药粉配方颗粒中不通过一号筛与能通过五号筛的颗粒的总和≤15%,优选≤14%;含油脂蒙药粉配方颗粒的粒度测定照《中国药典》(2020年版)粒度和粒度分布法(通则0982第二法)测定,不通过一号筛与能通过五号筛的颗粒总和不得超过供试品总重量的15%。
本发明还提供了上述方案所述含油脂蒙药粉配方颗粒的制备方法,包括以下步骤:
将含油脂蒙药低温粉碎后过筛,得到含油脂蒙药原粉;
将所述含油脂蒙药原粉、碳酸钙和淀粉浆混合进行湿法制粒,将所得湿粒干燥,得到含油脂蒙药粉配方颗粒。
本发明将含油脂蒙药低温粉碎后过筛,得到含油脂蒙药原粉。在本发明中,所述低温粉碎的温度为-20~-40℃,优选为-20~-25℃;本发明在-20~-40℃下进行低温粉碎,通过低温降低含油脂蒙药的粘附性,增加其脆性,从而提高粉碎效率。
在本发明中,所述过筛优选为过100目筛,筛下物为含油脂蒙药原粉;所述过筛优选使用电磁振动筛进行;本发明优选使用电磁振动筛,能够将粘性较强的药材细粉进行有效的筛分。
得到含油脂蒙药原粉后,本发明将所述含油脂蒙药原粉、碳酸钙和淀粉浆混合进行湿法制粒,将所得湿粒干燥,得到含油脂蒙药粉配方颗粒。在本发明中,所述混合优选为先将含油脂蒙药原粉和碳酸钙混合20~40min,优选混合30min,然后加入淀粉浆进行混合;本发明对所述混合的方法没有特殊要求,能够将物料混合均匀,得到粘性适宜的软材即可。
在本发明中,所述湿法制粒所用筛网的目数优选为14~16目,更优选为15目;所述湿法制粒具体优选为:将混合所得软材挤压过筛,得到粒径一致的湿粒。
得到湿粒后,本发明将所得湿粒进行干燥,在本发明中,所述干燥的温度为30~40℃,更优选为35~40℃,所述干燥优选以干燥至颗粒的含水量≤9%为准。
干燥后,本发明优选将所得干颗粒进行整粒,得到含油脂蒙药粉配方颗粒;所述整粒用筛网的目数优选为18~20目;本发明通过整粒提高湿粒的圆滑度,从而提高其流动性和润滑性。
在本发明的具体实施例中,优选将所得含油脂蒙药粉配方颗粒使用内包装材料分装,然后进行外包装,包装完成后送检,检查合格后入库保存。在本发明中,所述含油脂蒙药粉配方颗粒的检验优选包括剂型检验和质量标准鉴定;所述剂型检验优选包括粒度、水分、装量差异、装量和微生物限度的检验,上述各项检验均按照《中国药典四部通则0104》中的方法进行检验;所述质量标准鉴定优选按照《内蒙古蒙药饮片炮制规范》(2020年版)同名饮片项下规定进行检验。
在本发明中,上述低温粉碎、过筛、混合、湿法制粒、干燥、整粒和分装的过程均优选在D级洁净区中进行。
下面将结合本发明中的实施例,对本发明中的技术方案进行清楚、完整地描述。
实施例1
肉豆蔻粉配方颗粒的制备,原料为肉豆蔻、碳酸钙和淀粉浆,淀粉浆的质量浓度为10%,后续简称为10%淀粉浆,原料的用量比见表1。
制备方法如下:将肉豆蔻称量后进行粉碎,将粉碎料使用电磁振动筛进行筛分,得到100目的肉豆蔻原粉;将所述肉豆蔻原粉和碳酸钙混合30min,然后加入10%淀粉浆进行混合,得到软材;将所述软材进行挤压过16目筛,将所得湿粒40℃下干燥至含水量低于10%,然后使用20目筛整粒,得到熊胆粉配方颗粒;使用内包装材料将肉豆蔻粉配方颗粒进行分装,然后包上外包装,送检合格后入库保存。所述肉豆蔻粉配方颗粒的制备流程见图1。
对所得肉豆蔻粉配方颗粒的休止角、CRH值(临界相对湿度)和颗粒出成率进行检测,其中休止角用于表征颗粒的流动性和润滑性,休止角越小,颗粒的流动性越好,越能满足颗粒生产过程中流动性的要求,在具体实施例中,休止角≤41°,可认为满足生产要求;CRH值用于表征药物的稳定性,CRH值越大,说明吸湿性下降,稳定性增加;颗粒出成率用于表征混合所得软材的成型性和可压性,颗粒出成率高,证明混合所得软材的成型性和可压性越好。测试结果见表1。
以未制粒的肉豆蔻粉(即肉豆蔻散)为对比,按照相同的方法测试其休止角和CRH值,测试结果见表1。
表1肉豆蔻粉配方颗粒的原料比例和性能测试结果
根据表1可以看出,辅料碳酸钙的加入比例会影响所得肉豆蔻粉配方颗粒的流动性、稳定性和成型性,其中当肉豆蔻、碳酸钙和10%淀粉浆的质量比为75:20:50时,所得肉豆蔻粉配方颗粒的流动性、稳定性最好,且颗粒出成率最高,和肉豆蔻散相比,所得肉豆蔻粉配方颗粒的休止角下降17.3°,说明物料流动性增加,分剂量准确,CRH值增加4.7%,说明吸湿性下降而稳定性增加,适口性增强,达到临床服用顺应性提高的效果;当肉豆蔻、碳酸钙和10%淀粉浆的质量比为70:25:50时,所得肉豆蔻粉配方颗粒的休止角>41°,不能满足要求;当肉豆蔻、碳酸钙和10%淀粉浆的质量比为80:15:50时,颗粒休止角增大至47.8°,不能满足生产要求,且颗粒出成率低于90%。
另外,当肉豆蔻、碳酸钙和10%淀粉浆的质量比为70:25:50时,所得配方颗粒的硬度和脆性较为理想,便于分装、运输储存和使用。
实施例2
本实验测试低温粉碎的温度对粉碎效果的影响:取相同质量(200g)的肉豆蔻三份,在不同低温下进行粉碎,粉碎时间均为20min,取出粉末进行粒度分布分析,结果见下表。
表2不同低温条件对粉碎效率的影响
含油脂蒙药油性物质和脂肪含量较多,粉碎难以进行,本发明采用低温粉碎的方法来增加脆性,提高粉碎效率,配方颗粒的制粒粉末粒度是100目为最佳。根据表2中的数据可以看出,低温粉碎的温度对粉碎效果有明显的的影响,当粉碎温度为-5℃时,所得粉末中100目粉仅为5%,而粉碎温度为-20℃和-40℃时,所得粉末中100目粉的比例可以达到95%和95.5%,从能耗角度考虑,选择-20℃下进行低温粉碎为最佳条件。
实施例3
草果粉配方颗粒的制备,原料为草果、碳酸钙和10%淀粉浆,其中草果、碳酸钙和淀粉浆的质量比为75:21:50。制备方法同实施例1。
对所得配方颗粒的休止角、CRH值、粒度、颗粒出成率、药含量和水分含量进行测试,并对药物质量进行检验,所得结果见表3。其中粒度测定照《中国药典》(2020年版)粒度和粒度分布法(通则0982第二法)测定,不通过一号筛与能通过五号筛的总和不得超过15%;药物质量检验照《内蒙古蒙药饮片炮制规范》(2020年版)相应品种项下标准进行。
实施例4
丁香粉配方颗粒的制备,原料为丁香、碳酸钙和10%淀粉浆,其中丁香、碳酸钙和淀粉浆的质量比为75:20:50。制备方法同实施例1。
对所得配方颗粒的休止角、CRH值、粒度、颗粒出成率、药含量和水分含量进行测试,并对药物质量进行检验,所得结果见表3。
实施例5
决明子粉配方颗粒的制备,原料为决明子、碳酸钙和10%淀粉浆,其中其中决明子、碳酸钙和淀粉浆的质量比为75:19:60。制备方法同实施例1。
对所得配方颗粒的休止角、CRH值、粒度、颗粒出成率、药含量和水分含量进行测试,并对药物质量进行检验,所得结果见表3。
实施例6
牦牛心粉配方颗粒的制备,原料为牦牛心、碳酸钙和10%淀粉浆,其中其中其中牦牛心、碳酸钙和淀粉浆的质量比为75:20:50。制备方法同实施例1。
对所得配方颗粒的休止角、CRH值、粒度、颗粒出成率、药含量和水分含量进行测试,并对药物质量进行检验,所得结果见表3。
实施例7
牛胆粉配方颗粒的制备,原料为牛胆粉、碳酸钙和10%淀粉浆,其中牛胆粉、碳酸钙和10%淀粉浆的质量比为75:19:60。制备方法同实施例1。
对所得配方颗粒的休止角、CRH值、粒度、颗粒出成率、药含量和水分含量进行测试,并对药物质量进行检验,所得结果见表3。
对实施例1中肉豆蔻、碳酸钙和10%淀粉浆比例为75:20:50时制备的肉豆蔻粉配方颗粒的粒度、药含量和水分含量进行测试,并对药物质量进行检验,将结果列于表3中。
表3含油脂类蒙药粉配方颗粒
根据表3中的数据可以看出,本发明以碳酸钙为吸收剂、以10%淀粉浆为粘合剂,能够将不同油脂含量的含油脂蒙药制备成流动性符合要求的配方颗粒,且颗粒出成率高,药物性质稳定。
实施例8
分别以豆蔻、制巴豆、制木鳖、白芝麻、波棱瓜子、亚麻子和蓖麻子为原料,按照含油脂蒙药、碳酸钙和10%淀粉浆的质量比为75:20:50的比例制备成配方颗粒,其他制备条件和实施例1相同。
分别以苘麻子、蓖麻霜、黑芝麻、芥子、生草果仁、火麻仁、荠菜和炒马钱子为原料,按照含油脂蒙药、碳酸钙和10%淀粉浆的质量比为75:21:50的比例制备成配方颗粒,其他制备条件和实施例1相同。
分别以角茴香、天仙子、砂仁、荜茇、益智仁、香旱芹、沉香、肉桂和牛蒡子原料,按照含油脂蒙药、碳酸钙和10%淀粉浆的质量比为75:20:50的比例制备成配方颗粒,其他制备条件和实施例1相同。
分别以炒决明子、菥蓂子、大托叶云实、蔓荆子、槟榔、小蜀季、橡子粉、黑种草子、冬葵果和黑巨胜为原料,按照含油脂蒙药、碳酸钙和淀粉浆的质量比为75:19:60的比例制备成配方颗粒,其他制备条件和实施例1相同。
分别以牛心干、野兔心、制蛤蚧、猪血和驴血为原料,按照含油脂蒙药、碳酸钙和淀粉浆的质量比为75:20:50的比例制备成配方颗粒,其他制备条件和实施例1相同。
分别以全蝎、制斑蝥、海马、制牛鞭和炒牛角为原料,按照含油脂蒙药、碳酸钙和淀粉浆的质量比为75:19:60的比例制备成配方颗粒,其他制备条件和实施例1相同。
对上述所得配方颗粒进行休止角、CRH值、粒度、颗粒出成率、药含量和水分含量进行测试,结果显示所得配方颗粒的休止角均在41°以下,CRH值均在65%以上,颗粒出成率均为96%以上,且粒度、药含量和水分含量均符合要求,配方颗粒的质量均符合《内蒙古蒙药饮片炮制规范》(2020年版)中的要求。
由以上实施例可以看出,本发明以国家药品研发中“药物物质基础不改变”为宗旨,应用现代药剂学的技术方法,将含油脂蒙药单味饮片粉碎后进行湿法制粒,制成新型配方颗粒,可供蒙医临床使用,克服了蒙药散剂服用极为不便的缺点,有利于实现临证配剂、辩证施药;并且本发明提供的制备方法简单,容易进行工业化生产,有助于使繁杂而精确技术要求的配方工作实现自动化、智能化。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种含油脂蒙药粉配方颗粒,其特征在于,制备原料包括含油脂蒙药、碳酸钙和淀粉浆;所述含油脂蒙药、碳酸钙和淀粉浆的质量比为74~76:17~25:40~60;所述淀粉浆的质量浓度为8~12%;所述含油脂蒙药粉配方颗粒中含油脂蒙药的质量分数为74.7~75.1%。
2.根据权利要求1所述的含油脂蒙药粉配方颗粒,其特征在于,所述淀粉浆的质量浓度为10%。
3.根据权利要求1或2所述的含油脂蒙药粉配方颗粒,其特征在于,所述含油脂蒙药以含油脂蒙药原粉的形式使用,所述含油脂蒙药原粉的目数≤100目。
4.根据权利要求1或2所述的含油脂蒙药粉配方颗粒,其特征在于,所述含油脂蒙药为丁香、大托叶云实、小蜀季、天仙子、牛心干、牛胆粉、牛蒡子、火麻仁、生草果仁、白巨胜、白芝麻、冬葵果、亚麻子、肉豆蔻、肉桂、全蝎、决明子、芥子、豆蔻、角茴香、沉香、驴血、苦杏仁、苘麻子、制木鳖、制牛鞭、制巴豆、制斑蝥、制蛤蚧、牦牛心、炒马钱子、炒牛角、炒决明子、炒波棱瓜子、波棱瓜子、荜茇、草果、荠菜、茺蔚子、砂仁、香旱芹、独活、核桃仁、益智仁、烘白花蛇、海马、菥蓂子、野牛心、野兔心、猪血、斑蝥、葶苈子、黑巨胜、黑芝麻、黑种草子、蓖麻子、蓖麻霜、蔓荆子、槟榔或橡子。
5.根据权利要求4所述的含油脂蒙药粉配方颗粒,其特征在于,当所述含油脂蒙药的油含量≥5wt%时,所述含油脂蒙药和碳酸钙的质量比为75:20~23:40~60;
当所述蒙药的油含量大于等于2wt%且小于5wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~22:40~60;
当所述蒙药的油含量大于等于1wt%且小于2wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~20:40~60;
当所述蒙药的油含量小于1wt%时,所述含油脂蒙药和碳酸钙的质量比为75:18~19:40~60;
当所述蒙药的脂含量为1~2wt%时,所述含油脂蒙药和碳酸钙的质量比为75:19~20:40~60;
当所述蒙药的脂含量小于1wt%时,所述含油脂蒙药和碳酸钙的质量比为75:18~19:40~60。
6.根据权利要求4所述的含油脂蒙药粉配方颗粒,其特征在于,所述含油脂蒙药粉配方颗粒的含水量≤9%;所述含油脂蒙药粉配方颗粒的休止角≤41°;所述含油脂蒙药粉配方颗粒中不通过一号筛与能通过五号筛的颗粒的总和≤15%。
7.权利要求1~6任意一项所述含油脂蒙药粉配方颗粒的制备方法,其特征在于,包括以下步骤:
将含油脂蒙药低温粉碎后过筛,得到含油脂蒙药原粉;所述低温粉碎的温度为-20~-40℃;
将所述含油脂蒙药原粉、碳酸钙和淀粉浆混合进行湿法制粒,将所得湿粒干燥,得到含油脂蒙药粉配方颗粒。
8.根据权利要求7所述的制备方法,其特征在于,所述过筛为过100目筛,筛下物为含油脂蒙药原粉;
所述混合为:先将含油脂蒙药原粉和碳酸钙混合20~40min,然后加入淀粉浆进行混合。
9.根据权利要求7所述的制备方法,其特征在于,所述湿法制粒所用筛网的目数为14~16目;
所述干燥的温度为30~40℃。
10.根据权利要求7或9所述的制备方法,其特征在于,所述干燥后,还包括将所得干颗粒进行整粒;所述整粒用筛网的目数为18~20目。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202110324317.0A CN112972402B (zh) | 2021-03-26 | 2021-03-26 | 一种含油脂蒙药粉配方颗粒及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202110324317.0A CN112972402B (zh) | 2021-03-26 | 2021-03-26 | 一种含油脂蒙药粉配方颗粒及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN112972402A true CN112972402A (zh) | 2021-06-18 |
CN112972402B CN112972402B (zh) | 2022-09-20 |
Family
ID=76333780
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202110324317.0A Active CN112972402B (zh) | 2021-03-26 | 2021-03-26 | 一种含油脂蒙药粉配方颗粒及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN112972402B (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112891377A (zh) * | 2021-03-26 | 2021-06-04 | 宋亚红 | 一种贵细蒙药粉配方颗粒及其制备方法 |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101024066A (zh) * | 2006-02-19 | 2007-08-29 | 刘洁 | 金嗓利咽制剂及其制备方法 |
US20080111269A1 (en) * | 2006-11-10 | 2008-05-15 | Giovanni Politi | Granules, tablets and granulation |
US20080265222A1 (en) * | 2004-11-03 | 2008-10-30 | Alex Ozersky | Cellulose-Containing Filling Material for Paper, Tissue, or Cardboard Products, Method for the Production Thereof, Paper, Tissue, or Carboard Product Containing Such a Filling Material, or Dry Mixture Used Therefor |
CN102106870A (zh) * | 2009-11-25 | 2011-06-29 | 胡志彤 | 高密度碳酸钙颗粒的制造方法 |
CN105901150A (zh) * | 2016-03-31 | 2016-08-31 | 郎法文 | 一种阿胶钙奶片及其制备方法 |
CN106262801A (zh) * | 2016-04-17 | 2017-01-04 | 马鞍山市志诚科技有限公司 | 一种防治血栓性静脉炎的营养配方纳米颗粒及制备加工方法 |
EP3622966A1 (en) * | 2018-09-17 | 2020-03-18 | Omya International AG | High performance excipient comprising co-processed microcrystalline cellulose and surface-reacted calcium carbonate |
-
2021
- 2021-03-26 CN CN202110324317.0A patent/CN112972402B/zh active Active
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080265222A1 (en) * | 2004-11-03 | 2008-10-30 | Alex Ozersky | Cellulose-Containing Filling Material for Paper, Tissue, or Cardboard Products, Method for the Production Thereof, Paper, Tissue, or Carboard Product Containing Such a Filling Material, or Dry Mixture Used Therefor |
CN101024066A (zh) * | 2006-02-19 | 2007-08-29 | 刘洁 | 金嗓利咽制剂及其制备方法 |
US20080111269A1 (en) * | 2006-11-10 | 2008-05-15 | Giovanni Politi | Granules, tablets and granulation |
CN102106870A (zh) * | 2009-11-25 | 2011-06-29 | 胡志彤 | 高密度碳酸钙颗粒的制造方法 |
CN105901150A (zh) * | 2016-03-31 | 2016-08-31 | 郎法文 | 一种阿胶钙奶片及其制备方法 |
CN106262801A (zh) * | 2016-04-17 | 2017-01-04 | 马鞍山市志诚科技有限公司 | 一种防治血栓性静脉炎的营养配方纳米颗粒及制备加工方法 |
EP3622966A1 (en) * | 2018-09-17 | 2020-03-18 | Omya International AG | High performance excipient comprising co-processed microcrystalline cellulose and surface-reacted calcium carbonate |
Non-Patent Citations (3)
Title |
---|
任璐彤等: "蒙药豆蔻八味胶囊挥发油提取工艺与包合工艺的研究", 《中国民族医药杂志》 * |
范晓良等: "丁香配方颗粒中挥发油的测定及其质量控制", 《中国药师》 * |
马琍琍等: "微孔淀粉在丁香挥发油固化中的应用研究", 《药学与临床研究》 * |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112891377A (zh) * | 2021-03-26 | 2021-06-04 | 宋亚红 | 一种贵细蒙药粉配方颗粒及其制备方法 |
CN112891377B (zh) * | 2021-03-26 | 2023-09-19 | 那生桑 | 一种贵细蒙药粉配方颗粒及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN112972402B (zh) | 2022-09-20 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9132195B2 (en) | Cellulose powder having excellent segregation preventive effect, and compositions thereof | |
CN101524377B (zh) | 破壁灵芝孢子粉与环糊精的组合物及其制备方法 | |
CN102511800B (zh) | 一种保健食品胶囊及其制备方法 | |
CN112972402B (zh) | 一种含油脂蒙药粉配方颗粒及其制备方法 | |
CN113057999B (zh) | 一种树脂类蒙药粉配方颗粒及其制备方法 | |
CN108310056A (zh) | 一种无添加中药材破壁粉颗粒制剂的制备方法 | |
TWI549700B (zh) | 一種三七破壁製劑 | |
CN103610054A (zh) | 一种减肥通便的保健食品及其制备方法 | |
CN108938866A (zh) | 一种稳定血竭中血竭素含量的活血壮筋丸的制备方法 | |
CN112891377B (zh) | 一种贵细蒙药粉配方颗粒及其制备方法 | |
CN109985079B (zh) | 一种包含人参和三七花双层片的制备方法及应用 | |
CN106729009A (zh) | 大蒜油维生素e软胶囊及其制备方法 | |
CN111110696A (zh) | 一种组合物、制剂及用途 | |
CN113633708B (zh) | 一种稳定的跌打七厘组合物片的制备方法 | |
CN108785476A (zh) | 含有阿萨伊果和肉苁蓉的固体组合物的制备方法和应用 | |
CN101199602B (zh) | 一种治疗妇科疾病的含药软胶囊及其制备方法 | |
CN1954880A (zh) | 安神补脑颗粒剂及其制备方法 | |
Gajdziok et al. | The evaluation of formulations for the preparation of new formula pellets | |
CN105901720A (zh) | 一种降低酒精性肝损伤危害的保健食品及其制备方法 | |
Ratmelya et al. | Test anti-aging activity in a face scrub preparation that contains coffee-grade active charcoal (Coffea arabica L.) with the addition of vitamin E | |
CN102784116A (zh) | 一种高溶出度非诺贝特分散片及其制备方法 | |
CN113575958B (zh) | 提高免疫力功能的保健组合物、胶囊及制备方法 | |
CN109170912A (zh) | 一种l-硒-甲基硒代半胱氨酸颗粒剂及其制备方法 | |
CN104547436A (zh) | 一种博尔宁中药组合物胶囊及其制备方法 | |
CN110496141B (zh) | 一种含冬虫夏草的药物组合物 |
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 | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20210902 Address after: 010000 9-0601, Shihua building, Xueyuan East Street, Saihan District, Hohhot, Inner Mongolia Autonomous Region Applicant after: Na Shengsang Applicant after: Song Hongchun Applicant after: Wang Wei Address before: 010000 No.8, unit 1, building 24, Jianshe Lane Medical College, Huimin District, Hohhot, Inner Mongolia Autonomous Region Applicant before: Song Hongchun |
|
TA01 | Transfer of patent application right | ||
GR01 | Patent grant | ||
GR01 | Patent grant |