CN109562073A - 白蛋白药物组合物及其制备方法 - Google Patents

白蛋白药物组合物及其制备方法 Download PDF

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Publication number
CN109562073A
CN109562073A CN201780047050.7A CN201780047050A CN109562073A CN 109562073 A CN109562073 A CN 109562073A CN 201780047050 A CN201780047050 A CN 201780047050A CN 109562073 A CN109562073 A CN 109562073A
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albumin
content
pharmaceutical composition
amino acid
dimer
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CN109562073B (zh
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苏正兴
杨立开
赵栋
王玉君
单凤英
王可兴
王利春
王晶翼
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Sichuan Kelun Pharmaceutical Research Co Ltd
Sichuan Kelun Pharmaceutical Research Institute Co Ltd
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Sichuan Kelun Pharmaceutical Research Institute Co Ltd
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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5169—Proteins, e.g. albumin, gelatin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/5123—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

一种白蛋白药物组合物，该药物组合物包含白蛋白和至少一种相对分子量为145‑175的氨基酸。该白蛋白药物组合物可以有效降低临床使用因白蛋白多聚体和二聚体引起的人体内不期望的响应，如疹子、荨麻疹、过敏反应和可能的免疫应答，进一步保障临床用药安全性。

Description

PCT国内申请，说明书已公开。

Claims (17)

  1. PCT国内申请，权利要求书已公开。
CN201780047050.7A 2016-09-29 2017-09-21 白蛋白药物组合物及其制备方法 Active CN109562073B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2016108641421 2016-09-29
CN201610864142 2016-09-29
PCT/CN2017/102772 WO2018059304A1 (zh) 2016-09-29 2017-09-21 白蛋白药物组合物及其制备方法

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CN109562073B CN109562073B (zh) 2021-11-09

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US (2) US11154511B2 (zh)
CN (1) CN109562073B (zh)
WO (1) WO2018059304A1 (zh)

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Publication number Priority date Publication date Assignee Title
WO2017123760A1 (en) 2016-01-15 2017-07-20 Qun Sun Compositions and formulations including cabazitaxel and human serum albumin
US11413265B2 (en) 2018-04-20 2022-08-16 Zhuhai Beihai Biotech Co., Ltd. Formulations and compositions of Cabazitaxel
JP2024510156A (ja) 2021-03-05 2024-03-06 石薬集団中奇制薬技術（石家庄）有限公司 安定したドセタキセルアルブミンナノ粒子組成物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101745103A (zh) * 2010-01-19 2010-06-23 广东卫伦生物制药有限公司 可常温保存的白蛋白制剂
CN101954067A (zh) * 2010-08-25 2011-01-26 齐鲁制药有限公司 重组人血清白蛋白-干扰素α融合蛋白的水溶液及其制备方法
CN102327230A (zh) * 2011-09-30 2012-01-25 中国药科大学 一种包裹紫杉烷类药物的蛋白纳米颗粒及其制备方法
CN105078904A (zh) * 2015-06-25 2015-11-25 南京优科生物医药有限公司 一种卡巴他赛脂微球白蛋白冻干粉针及其制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2086874E (en) 1992-08-03 2000-01-04 Renzo Mauro Canetta Methods for administration of taxol
CN101361731A (zh) * 2008-08-11 2009-02-11 张文芳 白蛋白稳定的多西紫杉醇冻干制剂及其在治疗肿瘤方面的应用
CN101357126A (zh) * 2008-08-11 2009-02-04 张文芳 一种稳定的紫杉烷类白蛋白脂质载药系统及其制备方法
CN101658516B (zh) * 2008-08-26 2011-10-05 齐鲁制药有限公司 紫杉醇类药物组合物及其制备方法
CN103202813B (zh) 2010-08-09 2015-09-30 南京大学 一种制备用于体内递送药理活性物质的蛋白纳米粒的方法
CN103751107A (zh) 2013-12-18 2014-04-30 清华大学深圳研究生院 含有多烯紫杉醇和维生素e tpgs的纳米颗粒及其制备方法
CN106137969B (zh) 2015-04-03 2020-05-15 四川科伦药物研究院有限公司 多西他赛白蛋白纳米粒药物组合物及其制备方法及应用

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101745103A (zh) * 2010-01-19 2010-06-23 广东卫伦生物制药有限公司 可常温保存的白蛋白制剂
CN101954067A (zh) * 2010-08-25 2011-01-26 齐鲁制药有限公司 重组人血清白蛋白-干扰素α融合蛋白的水溶液及其制备方法
CN102327230A (zh) * 2011-09-30 2012-01-25 中国药科大学 一种包裹紫杉烷类药物的蛋白纳米颗粒及其制备方法
CN105078904A (zh) * 2015-06-25 2015-11-25 南京优科生物医药有限公司 一种卡巴他赛脂微球白蛋白冻干粉针及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
张强 等: "《药剂学》", 31 January 2005 *

Also Published As

Publication number Publication date
CN109562073B (zh) 2021-11-09
US11154511B2 (en) 2021-10-26
US20200108022A1 (en) 2020-04-09
US20220000792A1 (en) 2022-01-06
WO2018059304A1 (zh) 2018-04-05
US11931467B2 (en) 2024-03-19

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