CN107708723A - 神经生长因子组合物和注射粉剂 - Google Patents

神经生长因子组合物和注射粉剂 Download PDF

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Publication number
CN107708723A
CN107708723A CN201680023059.XA CN201680023059A CN107708723A CN 107708723 A CN107708723 A CN 107708723A CN 201680023059 A CN201680023059 A CN 201680023059A CN 107708723 A CN107708723 A CN 107708723A
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growth factor
nerve growth
composition
injection
stabilizer
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CN201680023059.XA
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CN107708723B (zh
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谭剑平
王炳璋
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Beijing Staidson New Pharmaceuticals Co ltd
Staidson Beijing Biopharmaceutical Co Ltd
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Beijing Staidson New Pharmaceuticals Co ltd
Staidson Beijing Biopharmaceutical Co Ltd
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    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/185—Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Psychology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

一种神经生长因子组合物和注射粉剂。所述神经生长因子组合物包括神经生长因子、稳定剂、支持剂、pH缓冲剂和水；所述稳定剂为精氨酸、谷氨酸、甘氨酸和异亮氨酸。所述神经生长因子组合物还包括表面活性剂。通过使用氨基酸代替白蛋白作为稳定剂，能够避免因白蛋白中携带病毒或其他未知成分带来的潜在风险；不仅对mNGF具有保护作用，同时可保证hNGF以及rhNGF在制备、运输及储存过程中保持良好的稳定性、临床用药安全性及质量可控性；组合物中成分明确，易于定性及定量，所用稳定剂纯度高，来源广，容易进行长期大量生产，便于控制成本及提高产品质量。

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。
CN201680023059.XA 2015-04-21 2016-04-18 神经生长因子组合物和注射粉剂 Active CN107708723B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201510190675 2015-04-21
CN2015101906751 2015-04-21
PCT/CN2016/079572 WO2016169455A1 (zh) 2015-04-21 2016-04-18 神经生长因子组合物和注射粉剂

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CN107708723A true CN107708723A (zh) 2018-02-16
CN107708723B CN107708723B (zh) 2021-04-13

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US (1) US20180110833A1 (zh)
EP (1) EP3287141B1 (zh)
CN (1) CN107708723B (zh)
DK (1) DK3287141T3 (zh)
ES (1) ES2893952T3 (zh)
WO (1) WO2016169455A1 (zh)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1552440A (zh) * 2003-06-06 2004-12-08 北京三诺佳邑生物技术有限责任公司 去白蛋白神经生长因子制剂
CN1802171A (zh) * 2003-06-10 2006-07-12 株式会社Lg生命科学 不包含血清白蛋白的人红细胞生成素的稳定水溶液
CN1824297A (zh) * 2005-12-30 2006-08-30 安徽金大陆生物制药有限公司 神经生长因子制品在制备治疗视神经病变药物中的应用
CN104023748A (zh) * 2011-10-28 2014-09-03 诚信生物公司 含有氨基酸的蛋白质制剂

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6277828B1 (en) * 1993-08-20 2001-08-21 Syntex (U.S.A.) Inc. Pharmaceutical formulations of nerve growth factor
CN100413535C (zh) * 2004-05-21 2008-08-27 舒泰神（北京）药业有限公司 神经生长因子在制备有效减轻体重的药物中的应用
KR20110022096A (ko) * 2005-12-20 2011-03-04 주식회사 삼양사 고분자 마이크로스피어의 제조 방법 및 제조 장치
WO2008045373A2 (en) * 2006-10-06 2008-04-17 Amgen Inc. Stable antibody formulations
CN101972470B (zh) * 2010-09-13 2012-10-17 舒泰神（北京）生物制药股份有限公司 一种眼用原位凝胶
CN101972224B (zh) * 2010-09-13 2012-01-04 舒泰神（北京）生物制药股份有限公司 一种眼用原位凝胶
CN102512664B (zh) * 2010-12-31 2015-04-01 舒泰神（北京）生物制药股份有限公司 一种神经生长因子组合物

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1552440A (zh) * 2003-06-06 2004-12-08 北京三诺佳邑生物技术有限责任公司 去白蛋白神经生长因子制剂
CN1802171A (zh) * 2003-06-10 2006-07-12 株式会社Lg生命科学 不包含血清白蛋白的人红细胞生成素的稳定水溶液
CN1824297A (zh) * 2005-12-30 2006-08-30 安徽金大陆生物制药有限公司 神经生长因子制品在制备治疗视神经病变药物中的应用
CN104023748A (zh) * 2011-10-28 2014-09-03 诚信生物公司 含有氨基酸的蛋白质制剂

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
赵小林等: "神经生长因子(NGF)制剂的稳定性试验", 《中国药师》 *

Also Published As

Publication number Publication date
WO2016169455A1 (zh) 2016-10-27
EP3287141A1 (en) 2018-02-28
ES2893952T3 (es) 2022-02-10
US20180110833A1 (en) 2018-04-26
CN107708723B (zh) 2021-04-13
EP3287141B1 (en) 2021-08-18
DK3287141T3 (da) 2021-10-11
EP3287141A4 (en) 2018-12-26

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