WO2019214196A1 - 一种广藿香配方颗粒喷雾干燥方法 - Google Patents

一种广藿香配方颗粒喷雾干燥方法 Download PDF

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Publication number
WO2019214196A1
WO2019214196A1 PCT/CN2018/114811 CN2018114811W WO2019214196A1 WO 2019214196 A1 WO2019214196 A1 WO 2019214196A1 CN 2018114811 W CN2018114811 W CN 2018114811W WO 2019214196 A1 WO2019214196 A1 WO 2019214196A1
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WO
WIPO (PCT)
Prior art keywords
spray drying
spray
patchouli
concentrated
drying method
Prior art date
Application number
PCT/CN2018/114811
Other languages
English (en)
French (fr)
Chinese (zh)
Inventor
张保献
李艳英
李欣欣
Original Assignee
北京盈科瑞创新医药股份有限公司
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Application filed by 北京盈科瑞创新医药股份有限公司 filed Critical 北京盈科瑞创新医药股份有限公司
Priority to JP2021510502A priority Critical patent/JP7150142B2/ja
Priority to KR1020207034397A priority patent/KR102466375B1/ko
Publication of WO2019214196A1 publication Critical patent/WO2019214196A1/zh

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    • 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
    • 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
    • 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
    • A61K36/532—Agastache, e.g. giant hyssop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Definitions

  • the invention relates to the technical field of traditional Chinese medicine formula granule production, in particular to an improved spray-drying method of patchouli granules, belonging to the technical field of traditional Chinese medicine production.
  • the traditional Chinese medicine formula granules are prepared by extracting and concentrating the single-flavored traditional Chinese medicine decoction pieces for the clinical formula of Chinese medicine.
  • Formerly known as single-flavor Chinese medicine concentrated granules the name of the commodity and the folk name are also free of Chinese herbal medicine pieces, new pieces, refined pieces, beverage-type pieces, scientific Chinese medicine and so on.
  • the drying process is an important part in the preparation of Chinese medicine formula granules.
  • traditional Chinese medicine extracts such as vacuum drying, freeze drying, fluidized bed drying, spray drying and the like.
  • spray drying has the advantages of short drying time, large drying area and less damage of active ingredients, and is an ideal method for drying liquid semi-liquid materials of traditional Chinese medicine.
  • the Chinese herb patchouli is the dry aerial part of the Pogostemon cablin (Blanco) Benth. It has the effect of aromatizing turbidity, and stopping vomiting, and releasing the effect of relieving heat. It is mainly used for the treatment of wet turbidity, vomiting, phlegm, phlegm, dampness, fever, burnout, chest tightness, cold and dampness. Abdominal pain, vomiting and diarrhea, nasal headache.
  • the Chinese invention patent application (CN107397787A) discloses a preparation process of a patchouli fresh-squeezed spray-dried granules, which concentrates the pressed patchouli medicinal juice under reduced pressure at 40-80 ° C to obtain a relative density of 1.02 to 1.10. The concentrated liquid is then spray dried, and the air inlet temperature is set to 100 to 140 ° C, and the outlet temperature is set to 90 to 120 ° C, and spray drying is directly performed.
  • the object of the present invention is to overcome the deficiencies of the prior art, to provide a process which is simple for industrial production, can effectively prevent the sticking phenomenon in the spray drying process, and effectively improve the yield of the dry paste powder in the spray drying process of the traditional Chinese medicine extract. Patchouli Chinese Herbal Formula Granule Spray Drying Process.
  • the technical solution adopted by the present invention is:
  • a method for spray drying a patchouli Chinese medicine formula comprising the steps of: taking a concentrated patchouli extract, then adding 2% to 5% beta cyclodextrin, mixing, filtering, and advancing
  • the air temperature was 175 ° C to 180 ° C, and the air temperature was 90 ° C to 95 ° C under spray drying to collect the dry paste powder.
  • the concentrated extract has a relative density of from 1.02 to 1.10, preferably from 1.03 to 1.10 at 60 °C.
  • the concentrated extract has a relative density of 1.05 to 1.08 at 60 °C.
  • the extract is added with 3% to 4% of betacyclodextrin.
  • 3% beta-cyclodextrin is added.
  • the inlet air temperature during spray drying is 175 ° C, and the outlet air temperature is 95 ° C.
  • the spray drying method has a dry paste yield of 78.02% to 96.56%, preferably 78.02%, 81.09%, 81.15%, 84.57%, 95.44% or 96.56%.
  • the amount of beta-cyclodextrin added in the present application is calculated based on the weight of the concentrated patchouli extract.
  • the concentrated patchouli extract was taken to have a relative density of 1.05 (60 ° C), spray-dried at an inlet air temperature of 175 ° C, and an outlet air temperature of 95 ° C to collect dry paste powder.
  • the concentrated patchouli extract was obtained at a relative density of 1.05 (60 ° C), then added with 3% cyclodextrin, mixed, filtered, and subjected to an inlet air temperature of 175 ° C and an outlet temperature of 95 ° C. Spray dry and collect dry paste powder.
  • the concentrated patchouli extract was taken at a relative density of 1.05 (60 ° C), then 4% beta-cyclodextrin was added, mixed, filtered, and subjected to an inlet air temperature of 175 ° C and an outlet air temperature of 95 ° C. Spray dry and collect dry paste powder.
  • the concentrated patchouli extract was taken at a relative density of 1.03 (60 ° C), then 3% times cyclodextrin was added, mixed, filtered, and subjected to an inlet air temperature of 175 ° C and an outlet temperature of 95 ° C. Spray dry and collect dry paste powder.
  • the concentrated patchouli extract was taken at a relative density of 1.01 (60 ° C), then 3% times cyclodextrin was added, mixed, filtered, and subjected to an inlet air temperature of 175 ° C and an outlet air temperature of 95 ° C. Spray dry and collect dry paste powder.
  • the concentrated patchouli extract was taken at a relative density of 1.11 (60 ° C), then 3% times cyclodextrin was added, mixed, filtered, and subjected to an inlet air temperature of 175 ° C and an outlet temperature of 95 ° C. Spray dry and collect dry paste powder.
  • the concentrated patchouli extract was taken at a relative density of 1.05 (60 ° C), then 1.5% beta-cyclodextrin was added, mixed, filtered, and subjected to an inlet air temperature of 175 ° C and an outlet temperature of 95 ° C. Spray dry and collect dry paste powder.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Medical Informatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Pulmonology (AREA)
  • Hospice & Palliative Care (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
PCT/CN2018/114811 2018-05-07 2018-11-09 一种广藿香配方颗粒喷雾干燥方法 WO2019214196A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2021510502A JP7150142B2 (ja) 2018-05-07 2018-11-09 広カッ香顆粒剤の噴霧乾燥方法
KR1020207034397A KR102466375B1 (ko) 2018-05-07 2018-11-09 광곽향 과립제의 분무 건조 방법

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201810425303.6A CN110448593A (zh) 2018-05-07 2018-05-07 一种广藿香配方颗粒喷雾干燥方法
CN201810425303.6 2018-05-07

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WO2019214196A1 true WO2019214196A1 (zh) 2019-11-14

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KR (1) KR102466375B1 (ja)
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WO (1) WO2019214196A1 (ja)

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Publication number Priority date Publication date Assignee Title
CN111494458B (zh) * 2020-05-18 2022-02-15 广州市香雪制药股份有限公司 一种广藿香配方颗粒制备方法

Citations (5)

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KR20090131256A (ko) * 2008-06-17 2009-12-28 주식회사파마펙스 함습 억제 및 방출속도 조절을 위한 생약추출물 함유 서방성 제제
CN101862458A (zh) * 2010-06-21 2010-10-20 谭登平 一种改善中药配方颗粒喷雾干燥工艺的辅料组合及其应用
WO2011043397A1 (ja) * 2009-10-09 2011-04-14 学校法人北里研究所 抗インフルエンザウイルス剤
CN104523862A (zh) * 2015-01-15 2015-04-22 广东一方制药有限公司 一种具有泻下作用的高浓缩大黄配方颗粒及其制备方法
CN107397787A (zh) * 2017-08-25 2017-11-28 徐自升 一种广藿香鲜榨喷雾干燥颗粒饮片的制备工艺

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JPS5724306A (en) * 1980-07-16 1982-02-08 Wakunaga Yakuhin Kk Preparation of solid chinese herbal pharmaceutical
JPS615024A (ja) * 1984-06-18 1986-01-10 Takeda Chem Ind Ltd 生薬製剤の製造法
WO2015115512A1 (ja) * 2014-01-29 2015-08-06 独立行政法人産業技術総合研究所 シクロデキストリンの利用による抗がん活性が増強されたアシュワガンダ葉の水抽出物の調製方法、及びアシュワガンダ葉を含む医薬組成物
CN107157937A (zh) * 2017-06-18 2017-09-15 徐漫 一种藿香鲜榨喷雾干燥颗粒饮片及其制备工艺

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WO2011043397A1 (ja) * 2009-10-09 2011-04-14 学校法人北里研究所 抗インフルエンザウイルス剤
CN101862458A (zh) * 2010-06-21 2010-10-20 谭登平 一种改善中药配方颗粒喷雾干燥工艺的辅料组合及其应用
CN104523862A (zh) * 2015-01-15 2015-04-22 广东一方制药有限公司 一种具有泻下作用的高浓缩大黄配方颗粒及其制备方法
CN107397787A (zh) * 2017-08-25 2017-11-28 徐自升 一种广藿香鲜榨喷雾干燥颗粒饮片的制备工艺

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JP2021519829A (ja) 2021-08-12
CN110448593A (zh) 2019-11-15
JP7150142B2 (ja) 2022-10-07
KR20210005706A (ko) 2021-01-14
KR102466375B1 (ko) 2022-11-10

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