WO2016045646A3 - 醋酸格拉替雷的制备方法 - Google Patents

醋酸格拉替雷的制备方法 Download PDF

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Publication number
WO2016045646A3
WO2016045646A3 PCT/CN2015/095606 CN2015095606W WO2016045646A3 WO 2016045646 A3 WO2016045646 A3 WO 2016045646A3 CN 2015095606 W CN2015095606 W CN 2015095606W WO 2016045646 A3 WO2016045646 A3 WO 2016045646A3
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WO
WIPO (PCT)
Prior art keywords
stirring
nca
solution
dissolving
preparation
Prior art date
Application number
PCT/CN2015/095606
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English (en)
French (fr)
Other versions
WO2016045646A2 (zh
Inventor
袁慧星
李国弢
刘建
马亚平
袁建成
Original Assignee
深圳翰宇药业股份有限公司
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 深圳翰宇药业股份有限公司 filed Critical 深圳翰宇药业股份有限公司
Priority to EA201790710A priority Critical patent/EA032855B1/ru
Priority to US15/513,995 priority patent/US10259909B2/en
Priority to EP15844092.5A priority patent/EP3199544B1/en
Publication of WO2016045646A2 publication Critical patent/WO2016045646A2/zh
Publication of WO2016045646A3 publication Critical patent/WO2016045646A3/zh

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2/00—Peptides of undefined number of amino acids; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G69/00—Macromolecular compounds obtained by reactions forming a carboxylic amide link in the main chain of the macromolecule
    • C08G69/02—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids
    • C08G69/04—Preparatory processes
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G69/00—Macromolecular compounds obtained by reactions forming a carboxylic amide link in the main chain of the macromolecule
    • C08G69/02—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids
    • C08G69/36—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids derived from amino acids, polyamines and polycarboxylic acids

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Polymers & Plastics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Epoxy Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

本发明涉及一种醋酸格拉替雷的制备方法，包括（1）在1，4-二氧六环溶剂中溶解L-丙氨酸NCA、L-酪氨酸NCA、L-谷氨酸-γ-苄酯NCA、L-ε-三氟乙酰基-赖氨酸NCA、搅拌至体系澄清；（2）加入二乙胺催化，20～25℃下搅拌，随后将反应液缓慢倒入水中，收集产生的白色产物；（3）将所得产物加入氢溴酸乙酸溶液中，23.0～25.0℃下搅拌，将反应液倒入纯化水中淬灭搅拌，抽滤得到黄色固体，重复3～5遍后，鼓风干燥去除固体中的水分；（4）将步骤（3）所得的固体用1M哌啶水溶液于室温下溶解并搅拌，得到的溶液经透析后，加冰乙酸调节pH为5.5～7.0，冻干即得。
PCT/CN2015/095606 2014-09-26 2015-11-26 醋酸格拉替雷的制备方法 WO2016045646A2 (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EA201790710A EA032855B1 (ru) 2014-09-26 2015-11-26 Способ получения глатирамера ацетата
US15/513,995 US10259909B2 (en) 2014-09-26 2015-11-26 Method for preparing glatiramer acetate
EP15844092.5A EP3199544B1 (en) 2014-09-26 2015-11-26 Preparation method for glatiramer acetate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201410504852.4 2014-09-26
CN201410504852.4A CN104844697B (zh) 2014-09-26 2014-09-26 醋酸格拉替雷的制备方法

Publications (2)

Publication Number Publication Date
WO2016045646A2 WO2016045646A2 (zh) 2016-03-31
WO2016045646A3 true WO2016045646A3 (zh) 2016-05-12

Family

ID=53844722

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2015/095606 WO2016045646A2 (zh) 2014-09-26 2015-11-26 醋酸格拉替雷的制备方法

Country Status (5)

Country Link
US (1) US10259909B2 (zh)
EP (1) EP3199544B1 (zh)
CN (1) CN104844697B (zh)
EA (1) EA032855B1 (zh)
WO (1) WO2016045646A2 (zh)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104844697B (zh) * 2014-09-26 2018-10-23 深圳翰宇药业股份有限公司 醋酸格拉替雷的制备方法
CN107522774B (zh) * 2016-06-22 2021-07-02 深圳翰宇药业股份有限公司 一种醋酸格拉替雷制备过程中哌啶残留量的实时控制方法
CN106279375A (zh) * 2016-11-03 2017-01-04 上海柏际医药科技有限公司 一种醋酸格拉替雷的制备方法
US20190202984A1 (en) * 2018-01-03 2019-07-04 Kinbio Ltd. Process of preparing glatiramer acetate
GB202219045D0 (en) 2022-12-16 2023-02-01 Univ Leeds Innovations Ltd Synthesis of poly(amino acids)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011022063A1 (en) * 2009-08-20 2011-02-24 Teva Pharmaceutical Industries Ltd. Low frequency glatiramer acetate therapy
CN103169670A (zh) * 2013-03-22 2013-06-26 深圳翰宇药业股份有限公司 一种醋酸格拉替雷微球及其制备方法
CN103641897A (zh) * 2013-11-27 2014-03-19 深圳翰宇药业股份有限公司 一种合成醋酸格拉替雷的方法
CN104844697A (zh) * 2014-09-26 2015-08-19 深圳翰宇药业股份有限公司 醋酸格拉替雷的制备方法

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5800808A (en) 1994-05-24 1998-09-01 Veda Research And Development Co., Ltd. Copolymer-1 improvements in compositions of copolymers
DE602005018800D1 (de) * 2004-09-09 2010-02-25 Teva Pharma Verfahren zur herstellung von polypeptidmischungen unter anwendung von aufgereinigter bromwasserstoffsäure
WO2006029411A2 (en) * 2004-09-09 2006-03-16 Yeda Research And Development Co. Ltd. Mixtures of polypeptides, compositions containing and processes for preparing same, and uses thereof
CA2619123A1 (en) * 2005-08-15 2007-02-22 Wai Hong Chan Process for the preparation of copolymer-1
WO2007146331A1 (en) * 2006-06-12 2007-12-21 Teva Pharmaceutical Industries, Ltd. Tannate salt form of polypeptide mixtures, their preparation and use
JP2011530523A (ja) * 2008-08-07 2011-12-22 サイノファーム タイワン リミテッド 酢酸グラチラマーの合成
ES2523732T5 (es) * 2009-04-03 2023-10-23 Momenta Pharmaceuticals Inc Control de composiciones de copolímeros
WO2012123959A2 (en) * 2011-02-14 2012-09-20 Usv Limited Copolymer-1, process for preparation and analytical methods thereof
CN102718963B (zh) * 2012-06-19 2014-10-15 深圳翰宇药业股份有限公司 聚合物多肽的制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011022063A1 (en) * 2009-08-20 2011-02-24 Teva Pharmaceutical Industries Ltd. Low frequency glatiramer acetate therapy
CN103169670A (zh) * 2013-03-22 2013-06-26 深圳翰宇药业股份有限公司 一种醋酸格拉替雷微球及其制备方法
CN103641897A (zh) * 2013-11-27 2014-03-19 深圳翰宇药业股份有限公司 一种合成醋酸格拉替雷的方法
CN104844697A (zh) * 2014-09-26 2015-08-19 深圳翰宇药业股份有限公司 醋酸格拉替雷的制备方法

Also Published As

Publication number Publication date
US10259909B2 (en) 2019-04-16
US20170298180A1 (en) 2017-10-19
CN104844697A (zh) 2015-08-19
EA201790710A1 (ru) 2017-11-30
CN104844697B (zh) 2018-10-23
WO2016045646A2 (zh) 2016-03-31
EP3199544A2 (en) 2017-08-02
EP3199544B1 (en) 2021-11-17
EA032855B1 (ru) 2019-07-31
EP3199544A4 (en) 2018-06-27

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