CN111655739A - 一种去除舒更葡糖钠中气相杂质和制备其无定型物的方法 - Google Patents

一种去除舒更葡糖钠中气相杂质和制备其无定型物的方法 Download PDF

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Publication number
CN111655739A
CN111655739A CN201980010521.6A CN201980010521A CN111655739A CN 111655739 A CN111655739 A CN 111655739A CN 201980010521 A CN201980010521 A CN 201980010521A CN 111655739 A CN111655739 A CN 111655739A
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China
Prior art keywords
sugammadex sodium
sugammadex
drying
sodium
gas
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Inventor
李发光
高宏
刘群
侯云泽
肖宇
白俊鹏
孟秋月
杨光
祁浩飞
王倩倩
王征
和潇夏
胡佰艳
霍翔宏
王�琦
王利春
王晶翼
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Sichuan Kelun Pharmaceutical Research Institute Co Ltd
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Tianjin Kelun Pharmaceutical Research 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/724—Cyclodextrins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

本发明公开了一种去除舒更葡糖钠中气相杂质的方法，包括水溶、蒸馏和干燥等步骤，条件温和，适用于工业放大，制备得到的舒更葡糖钠纯品的气相杂质个数及含量优于原研制剂产品。本发明还进一步公开了一种无定型舒更葡糖钠的制备方法，产物稳定性高，适合制剂生产。

Description

PCT国内申请，说明书已公开。

Claims (16)

  1. PCT国内申请，权利要求书已公开。
CN201980010521.6A 2018-03-28 2019-03-20 一种去除舒更葡糖钠中气相杂质和制备其无定型物的方法 Pending CN111655739A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201810266667 2018-03-28
CN2018102666674 2018-03-28
PCT/CN2019/078808 WO2019184773A1 (zh) 2018-03-28 2019-03-20 一种去除舒更葡糖钠中气相杂质和制备其无定型物的方法

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CN111655739A true CN111655739A (zh) 2020-09-11

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WO (1) WO2019184773A1 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110615860A (zh) * 2018-06-20 2019-12-27 江苏恒瑞医药股份有限公司 一种舒更葡糖钠的纯化方法
CN115708777A (zh) * 2021-08-19 2023-02-24 北京费森尤斯卡比医药有限公司 包含巯基环糊精衍生物或其可药用盐的包装药品和保存方法

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023515087A (ja) 2020-02-28 2023-04-12 メディチェム エセ．ア． スガマデクスを乾燥させるための方法
CN111320712B (zh) * 2020-04-09 2022-03-04 江苏海悦康医药科技有限公司 一种舒更葡糖钠分子内硫醚杂质的合成方法
WO2022055918A1 (en) * 2020-09-09 2022-03-17 Merck Sharp & Dohme Corp. Novel crystalline forms of sugammadex

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101712972B (zh) * 2009-12-18 2012-10-10 江南大学 一种生物法生产α-环糊精的生产工艺
US9879096B2 (en) * 2013-02-14 2018-01-30 Neuland Laboratories Limited Process for preparation of sugammadex sodium
CN107686530B (zh) * 2017-10-16 2019-09-13 河北坤安药业有限公司 一种舒更葡糖钠的合成方法
CN109053933B (zh) * 2018-08-01 2020-10-23 合肥博思科创医药科技有限公司 一种无定型舒更葡糖钠的制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110615860A (zh) * 2018-06-20 2019-12-27 江苏恒瑞医药股份有限公司 一种舒更葡糖钠的纯化方法
CN115708777A (zh) * 2021-08-19 2023-02-24 北京费森尤斯卡比医药有限公司 包含巯基环糊精衍生物或其可药用盐的包装药品和保存方法

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