BR112022004994A2 - Preparação contendo albumina humana e seu método de preparação - Google Patents

Preparação contendo albumina humana e seu método de preparação

Info

Publication number
BR112022004994A2
BR112022004994A2 BR112022004994A BR112022004994A BR112022004994A2 BR 112022004994 A2 BR112022004994 A2 BR 112022004994A2 BR 112022004994 A BR112022004994 A BR 112022004994A BR 112022004994 A BR112022004994 A BR 112022004994A BR 112022004994 A2 BR112022004994 A2 BR 112022004994A2
Authority
BR
Brazil
Prior art keywords
acid
preparation
human albumin
chain fatty
long
Prior art date
Application number
BR112022004994A
Other languages
English (en)
Inventor
Wei Xiang
Zhilei Yue
Original Assignee
Tonghua Anrate Biopharmaceutical Co Ltd
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 Tonghua Anrate Biopharmaceutical Co Ltd filed Critical Tonghua Anrate Biopharmaceutical Co Ltd
Publication of BR112022004994A2 publication Critical patent/BR112022004994A2/pt

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Classifications

    • 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
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A61K38/38Albumins
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10Antioedematous agents; Diuretics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/02Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Urology & Nephrology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

preparação contendo albumina humana e seu método de preparação. a presente invenção refere-se a um método para a preparação de uma preparação de albumina humana, o método compreendendo controlar o teor de um ácido graxo de cadeia longa na preparação; e adicionar um poloxâmero. o ácido graxo de cadeia longa é selecionado a partir de um ou mais de ácido mirístico, ácido palmítico, ácido esteárico, ácido oleico, ácido linoleico, ácido linolênico e ácido araquidônico, e a razão molar dos ácidos graxos de cadeia longa ácido para albumina humana é de 0,2 a 3,0. o teor do poloxâmero é de 10 a 500 microgramas por grama de albumina humana. a preparação de albumina humana preparada por meio do método tem uma estabilidade aprimorada e está livre de uma partícula com um tamanho de partícula de pelo menos 30 nm formado por agregação e/ou fibrilação de albumina humana.
BR112022004994A 2019-09-17 2020-04-22 Preparação contendo albumina humana e seu método de preparação BR112022004994A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910874343.3A CN112516291B (zh) 2019-09-17 2019-09-17 含人白蛋白的制剂及其制备方法
PCT/CN2020/086057 WO2021051807A1 (zh) 2019-09-17 2020-04-22 含人白蛋白的制剂及其制备方法

Publications (1)

Publication Number Publication Date
BR112022004994A2 true BR112022004994A2 (pt) 2022-06-21

Family

ID=74883661

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022004994A BR112022004994A2 (pt) 2019-09-17 2020-04-22 Preparação contendo albumina humana e seu método de preparação

Country Status (8)

Country Link
US (1) US20220313790A1 (pt)
EP (1) EP4032541A4 (pt)
JP (1) JP7414326B2 (pt)
KR (1) KR20220061964A (pt)
CN (1) CN112516291B (pt)
BR (1) BR112022004994A2 (pt)
CA (1) CA3154018A1 (pt)
WO (1) WO2021051807A1 (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114544926A (zh) * 2021-12-02 2022-05-27 浙江鑫科医疗科技有限公司 一种血清蛋白稳定剂
CN115677848A (zh) * 2022-10-24 2023-02-03 通化安睿特生物制药股份有限公司 一种制备高纯度高稳定性蛋白质的方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004075913A1 (ja) * 2003-02-28 2004-09-10 Chugai Seiyaku Kabushiki Kaisha タンパク質含有安定化製剤
CN1919339B (zh) * 2006-06-13 2013-01-23 沈阳药科大学 含有蛋白的葫芦素纳米制剂及制备方法和用途
CN101745103B (zh) * 2010-01-19 2011-09-28 广东卫伦生物制药有限公司 可常温保存的白蛋白制剂
AU2013230020B2 (en) 2012-03-07 2018-08-09 Janssen Biotech, Inc. Defined media for expansion and maintenance of pluripotent stem cells
US20150165000A1 (en) * 2012-12-18 2015-06-18 Ewha University - Industry Collaboration Foundation Composition for thermostabilization of human serum albumin and method of preparing thermally stabilized human serum albumin using the same
WO2018115953A1 (en) 2016-12-21 2018-06-28 Prometic Pharma Smt Limited Methods and compositions for preventing or minimizing epithelial-mesenchymal transition
CN107674860A (zh) * 2017-07-14 2018-02-09 上海源培生物科技股份有限公司 Nk92细胞无血清培养基

Also Published As

Publication number Publication date
EP4032541A4 (en) 2022-11-23
EP4032541A1 (en) 2022-07-27
US20220313790A1 (en) 2022-10-06
CN112516291B (zh) 2023-07-14
KR20220061964A (ko) 2022-05-13
JP7414326B2 (ja) 2024-01-16
WO2021051807A1 (zh) 2021-03-25
CA3154018A1 (en) 2021-03-25
JP2022545214A (ja) 2022-10-26
CN112516291A (zh) 2021-03-19

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