CN114306577B - 一种门冬胰岛素30混悬液的制备方法 - Google Patents

一种门冬胰岛素30混悬液的制备方法 Download PDF

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Publication number
CN114306577B
CN114306577B CN202011088818.5A CN202011088818A CN114306577B CN 114306577 B CN114306577 B CN 114306577B CN 202011088818 A CN202011088818 A CN 202011088818A CN 114306577 B CN114306577 B CN 114306577B
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CN
China
Prior art keywords
insulin aspart
solution
suspension
stirring
phenol
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Active
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CN202011088818.5A
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English (en)
Chinese (zh)
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CN114306577A (zh
Inventor
王玮
贡光杰
陈松
张昊宁
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Nanjing Hanxin Pharmaceutical Technology Co ltd
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Nanjing Hanxin Pharmaceutical Technology Co ltd
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Priority to CN202011088818.5A priority Critical patent/CN114306577B/zh
Priority to PCT/CN2020/126395 priority patent/WO2022073275A1/fr
Publication of CN114306577A publication Critical patent/CN114306577A/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Diabetes (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CN202011088818.5A 2020-10-10 2020-10-10 一种门冬胰岛素30混悬液的制备方法 Active CN114306577B (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202011088818.5A CN114306577B (zh) 2020-10-10 2020-10-10 一种门冬胰岛素30混悬液的制备方法
PCT/CN2020/126395 WO2022073275A1 (fr) 2020-10-10 2020-11-04 Procédé de préparation d'une suspension d'insuline asparte 30

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202011088818.5A CN114306577B (zh) 2020-10-10 2020-10-10 一种门冬胰岛素30混悬液的制备方法

Publications (2)

Publication Number Publication Date
CN114306577A CN114306577A (zh) 2022-04-12
CN114306577B true CN114306577B (zh) 2024-04-09

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CN202011088818.5A Active CN114306577B (zh) 2020-10-10 2020-10-10 一种门冬胰岛素30混悬液的制备方法

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Country Link
CN (1) CN114306577B (fr)
WO (1) WO2022073275A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2896375A1 (fr) * 2013-02-04 2014-08-07 Sanofi Formulations pharmaceutiques stabilisees d'analogues d'insuline et/ou de derives d'insuline
CN105899190A (zh) * 2014-01-09 2016-08-24 赛诺菲 门冬胰岛素的稳定化药物制剂
CN108096185A (zh) * 2017-12-20 2018-06-01 珠海冀百康生物科技有限公司 一种速效胰岛素制剂及其制备方法
CN108114270A (zh) * 2018-02-06 2018-06-05 美药星(南京)制药有限公司 一种门冬胰岛素注射液的制备方法
CN108778246A (zh) * 2016-01-07 2018-11-09 美药星制药股份有限公司 胰岛素和胰岛素类似物的高纯度可吸入颗粒及其高效制备方法

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK72793D0 (da) * 1993-06-21 1993-06-21 Novo Nordisk As Nyt produkt
CO4970787A1 (es) * 1997-12-23 2000-11-07 Lilly Co Eli Composiciones insolubles de insulina y derivados de insulina que controlan la glucosa sanguinea
JP4933455B2 (ja) * 2005-02-02 2012-05-16 ノヴォ ノルディスク アー/エス 新規のインスリン誘導体

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2896375A1 (fr) * 2013-02-04 2014-08-07 Sanofi Formulations pharmaceutiques stabilisees d'analogues d'insuline et/ou de derives d'insuline
CN105899190A (zh) * 2014-01-09 2016-08-24 赛诺菲 门冬胰岛素的稳定化药物制剂
CN108778246A (zh) * 2016-01-07 2018-11-09 美药星制药股份有限公司 胰岛素和胰岛素类似物的高纯度可吸入颗粒及其高效制备方法
CN108096185A (zh) * 2017-12-20 2018-06-01 珠海冀百康生物科技有限公司 一种速效胰岛素制剂及其制备方法
CN108114270A (zh) * 2018-02-06 2018-06-05 美药星(南京)制药有限公司 一种门冬胰岛素注射液的制备方法

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Publication number Publication date
WO2022073275A1 (fr) 2022-04-14
CN114306577A (zh) 2022-04-12

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