CN109789107A - 药物组合物 - Google Patents

药物组合物 Download PDF

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Publication number
CN109789107A
CN109789107A CN201780058758.2A CN201780058758A CN109789107A CN 109789107 A CN109789107 A CN 109789107A CN 201780058758 A CN201780058758 A CN 201780058758A CN 109789107 A CN109789107 A CN 109789107A
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Prior art keywords
suspension
pharmaceutical composition
sample
budesonide
spraying
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CN201780058758.2A
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CN109789107B (zh
Inventor
牟丽秋
丁丹
赵步文
曹立
游劲松
黄芳芳
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Guangdong HEC Pharmaceutical
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Sunshine Lake Pharma Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • 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
    • A61P11/06—Antiasthmatics
    • 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
    • A61P11/08—Bronchodilators

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

药物组合物，含有：吸入性糖皮质激素，和长效β2肾上腺素能受体激动剂；并且，该药物组合物中的颗粒粒度Dv(90)值为0.1～3.0微米。喷雾组件，包括上述药物组合物和喷雾装置。

Description

PCT国内申请，说明书已公开。

Claims (14)

  1. PCT国内申请，权利要求书已公开。
CN201780058758.2A 2016-09-29 2017-09-26 药物组合物 Active CN109789107B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201610864369 2016-09-29
CN2016108643696 2016-09-29
PCT/CN2017/103389 WO2018059390A1 (zh) 2016-09-29 2017-09-26 药物组合物

Publications (2)

Publication Number Publication Date
CN109789107A true CN109789107A (zh) 2019-05-21
CN109789107B CN109789107B (zh) 2021-12-03

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CN (1) CN109789107B (zh)
WO (1) WO2018059390A1 (zh)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114028364A (zh) * 2021-11-26 2022-02-11 南京华盖制药有限公司 一种奥达特罗吸入溶液
CN115381774A (zh) * 2022-08-30 2022-11-25 立生医药(苏州)有限公司 包含长效吸入性类固醇和长效β2受体激动剂组合的药物制剂
WO2023125472A1 (zh) * 2021-12-28 2023-07-06 广东东阳光药业有限公司 一种喷雾组件
CN116930381A (zh) * 2023-07-04 2023-10-24 南京力成药业有限公司 一种富马酸福莫特罗吸入溶液中非对映异构体杂质的检测方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111380968A (zh) * 2018-12-29 2020-07-07 天津药业研究院有限公司 一种奥达特罗含量和有关物质的检测方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1042203C (zh) * 1990-03-21 1999-02-24 泊灵格英格尔海姆国际有限公司 雾化方法及其计量剂量吸入器
EP1492500A1 (en) * 2002-04-05 2005-01-05 3M Innovative Properties Company Formoterol and ciclesonide aerosol formulations
CN102573791A (zh) * 2009-10-16 2012-07-11 雅戈泰克股份公司 改进的制剂
CN103462943A (zh) * 2005-07-15 2013-12-25 Map药物公司 在离散的吸入粒子中结合的多种活性药物成分及其制剂
CN104080444A (zh) * 2012-01-25 2014-10-01 奇斯药制品公司 用于吸入给药包含皮质类固醇和beta-肾上腺素能药物的干粉配制剂
CN104739811A (zh) * 2015-02-27 2015-07-01 上海臣邦医药科技有限公司 一种糖皮质激素雾化吸入混悬液及其制备方法
CN105748447A (zh) * 2016-03-08 2016-07-13 上海现代药物制剂工程研究中心有限公司 布地奈德和福莫特罗雾化吸入混悬液及其制备方法
EP3151812B1 (en) * 2014-06-09 2020-04-22 Chiesi Farmaceutici S.p.A. Inhalation particles comprising a combination of an anticholinergic, a corticosteroid and a beta-adrenergic

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1042203C (zh) * 1990-03-21 1999-02-24 泊灵格英格尔海姆国际有限公司 雾化方法及其计量剂量吸入器
EP1492500A1 (en) * 2002-04-05 2005-01-05 3M Innovative Properties Company Formoterol and ciclesonide aerosol formulations
CN103462943A (zh) * 2005-07-15 2013-12-25 Map药物公司 在离散的吸入粒子中结合的多种活性药物成分及其制剂
CN102573791A (zh) * 2009-10-16 2012-07-11 雅戈泰克股份公司 改进的制剂
CN104080444A (zh) * 2012-01-25 2014-10-01 奇斯药制品公司 用于吸入给药包含皮质类固醇和beta-肾上腺素能药物的干粉配制剂
EP3151812B1 (en) * 2014-06-09 2020-04-22 Chiesi Farmaceutici S.p.A. Inhalation particles comprising a combination of an anticholinergic, a corticosteroid and a beta-adrenergic
CN104739811A (zh) * 2015-02-27 2015-07-01 上海臣邦医药科技有限公司 一种糖皮质激素雾化吸入混悬液及其制备方法
CN105748447A (zh) * 2016-03-08 2016-07-13 上海现代药物制剂工程研究中心有限公司 布地奈德和福莫特罗雾化吸入混悬液及其制备方法

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
JERRY Z. YANG等: ""Fluticasone and Budesonide Nanosuspensions for Pulmonary Delivery: Preparation, Characterization, and Pharmacokinetic Studies"", 《JOURNAL OF PHARMACEUTICAL SCIENCES》 *
国家食品药品监督管理局政策法规司编: "《食品药品监督管理规范性文件汇编》", 31 December 2012, 中国医药科技出版社 *
国家食品药品监督管理总局执业药师资格认证中心: "《中药专业知识》", 28 February 2015, 中国医药科技出版社 *
阎锡新等主编: "《支气管哮喘》", 30 September 2007, 军事医学科学出版社 *
陈亮等: ""丙酸氟替卡松鼻喷雾剂的研制及喷雾特性"", 《中国药科大学学报》 *
黎伟等: ""吸入用布地奈德混悬液的处方和制备工艺的优化"", 《华西药学杂志》 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114028364A (zh) * 2021-11-26 2022-02-11 南京华盖制药有限公司 一种奥达特罗吸入溶液
WO2023125472A1 (zh) * 2021-12-28 2023-07-06 广东东阳光药业有限公司 一种喷雾组件
CN115381774A (zh) * 2022-08-30 2022-11-25 立生医药(苏州)有限公司 包含长效吸入性类固醇和长效β2受体激动剂组合的药物制剂
CN116930381A (zh) * 2023-07-04 2023-10-24 南京力成药业有限公司 一种富马酸福莫特罗吸入溶液中非对映异构体杂质的检测方法

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WO2018059390A1 (zh) 2018-04-05

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Address after: 523808 No.1, Gongye North Road, Songshanhu Park, Dongguan City, Guangdong Province

Patentee after: Guangdong Dongyangguang Pharmaceutical Co.,Ltd.

Address before: 523808 Songshan Lake Science and Technology Industrial Park, Dongguan City, Guangdong Province

Patentee before: SUNSHINE LAKE PHARMA Co.,Ltd.

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