CN1033738C - 含有粒性的细胞集落刺激因子的稳定药剂及其生产方法 - Google Patents
含有粒性的细胞集落刺激因子的稳定药剂及其生产方法 Download PDFInfo
- Publication number
- CN1033738C CN1033738C CN87104963A CN87104963A CN1033738C CN 1033738 C CN1033738 C CN 1033738C CN 87104963 A CN87104963 A CN 87104963A CN 87104963 A CN87104963 A CN 87104963A CN 1033738 C CN1033738 C CN 1033738C
- Authority
- CN
- China
- Prior art keywords
- csf
- acid
- molecular weight
- polyoxyethylene
- leu
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/193—Colony stimulating factors [CSF]
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- 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
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/14—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP16948886 | 1986-07-18 | ||
JP169486/86 | 1986-07-18 | ||
JP169489/86 | 1986-07-18 | ||
JP169488/86 | 1986-07-18 | ||
JP169487/86 | 1986-07-18 | ||
JP16948986 | 1986-07-18 | ||
JP16948786 | 1986-07-18 | ||
JP16948686 | 1986-07-18 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN87104963A CN87104963A (zh) | 1988-02-24 |
CN1033738C true CN1033738C (zh) | 1997-01-08 |
Family
ID=27474266
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN87104963A Expired - Lifetime CN1033738C (zh) | 1986-07-18 | 1987-07-18 | 含有粒性的细胞集落刺激因子的稳定药剂及其生产方法 |
Country Status (24)
Country | Link |
---|---|
KR (1) | KR930004597B1 (el) |
CN (1) | CN1033738C (el) |
AT (1) | AT402259B (el) |
AU (1) | AU611856B2 (el) |
BE (1) | BE1000253A3 (el) |
CA (1) | CA1297007C (el) |
CH (1) | CH671157A5 (el) |
DE (1) | DE3723781C2 (el) |
DK (1) | DK171308B1 (el) |
ES (1) | ES2010226A6 (el) |
FR (1) | FR2601591B1 (el) |
GB (1) | GB2193631B (el) |
GR (1) | GR871067B (el) |
HK (1) | HK64893A (el) |
HU (1) | HU198627B (el) |
IE (1) | IE60290B1 (el) |
IL (1) | IL83220A (el) |
IT (1) | IT1218927B (el) |
NL (1) | NL192917C (el) |
NO (1) | NO171828C (el) |
PT (1) | PT85343B (el) |
SE (1) | SE503312C2 (el) |
SG (1) | SG64393G (el) |
YU (1) | YU47543B (el) |
Families Citing this family (45)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4929442A (en) * | 1986-09-26 | 1990-05-29 | Exovir, Inc. | Compositions suitable for human topical application including a growth factor and/or related materials |
US4847325A (en) * | 1988-01-20 | 1989-07-11 | Cetus Corporation | Conjugation of polymer to colony stimulating factor-1 |
NO179479C (no) * | 1988-03-11 | 1996-10-16 | Teikoku Seiyaku Kk | Fremgangsmåte for fremstilling av et intravaginalt farmasöytisk preparat |
US5981485A (en) | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
GB8824591D0 (en) | 1988-10-20 | 1988-11-23 | Royal Free Hosp School Med | Fractionation process |
US5349052A (en) * | 1988-10-20 | 1994-09-20 | Royal Free Hospital School Of Medicine | Process for fractionating polyethylene glycol (PEG)-protein adducts and an adduct for PEG and granulocyte-macrophage colony stimulating factor |
US6132763A (en) * | 1988-10-20 | 2000-10-17 | Polymasc Pharmaceuticals Plc | Liposomes |
US5104651A (en) * | 1988-12-16 | 1992-04-14 | Amgen Inc. | Stabilized hydrophobic protein formulations of g-csf |
JP3249147B2 (ja) * | 1990-06-01 | 2002-01-21 | キリン−アムジエン・インコーポレーテツド | 生理活性蛋白含有経口製剤 |
EP0459516A1 (en) * | 1990-06-01 | 1991-12-04 | Kirin-Amgen, Inc. | Oral dosage form of biologically active proteins |
FR2686900B1 (fr) * | 1992-01-31 | 1995-07-21 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides ayant une activite de stimulation des colonies de granulocytes, leur preparation et compositions pharmaceutiques les contenant. |
FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
FR2693907B1 (fr) * | 1992-07-23 | 1994-09-02 | Rhone Poulenc Rorer Sa | Procédé d'administration de solutions de facteur de stimulation des colonies granulocytaires. |
EP0582932A1 (de) * | 1992-08-11 | 1994-02-16 | F. Hoffmann-La Roche Ag | Therapeutisches System zur parenteralen Verabreichung von hämatopoetischen Wachstumsfaktoren |
DE4242919A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF |
DE4242863A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF |
US20030053982A1 (en) | 1994-09-26 | 2003-03-20 | Kinstler Olaf B. | N-terminally chemically modified protein compositions and methods |
US5824784A (en) | 1994-10-12 | 1998-10-20 | Amgen Inc. | N-terminally chemically modified protein compositions and methods |
JP2000510813A (ja) * | 1995-02-06 | 2000-08-22 | ジェネテイックス・インスティテュート・インコーポレイテッド | Il−12用処方 |
TW434021B (en) * | 1995-03-15 | 2001-05-16 | Kirin Brewery | Methods for preventing adsorption of thrombopoietin (TPO), and stable TPO-containing compositions |
TW434020B (en) * | 1995-03-15 | 2001-05-16 | Kirin Brewery | Methods for preventing adsorption of thrombopoietin (TPO), and stable top-containing compositions |
GB9526733D0 (en) | 1995-12-30 | 1996-02-28 | Delta Biotechnology Ltd | Fusion proteins |
US20030190307A1 (en) | 1996-12-24 | 2003-10-09 | Biogen, Inc. | Stable liquid interferon formulations |
AU749815B2 (en) * | 1998-03-06 | 2002-07-04 | Chugai Seiyaku Kabushiki Kaisha | Protein-free preparations |
US6979442B1 (en) * | 1998-08-17 | 2005-12-27 | Pfizer Inc. | Stabilized protein compositions |
ATE389414T1 (de) * | 1999-09-08 | 2008-04-15 | Chugai Pharmaceutical Co Ltd | Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselben |
US7163671B2 (en) * | 2000-02-29 | 2007-01-16 | Chugai Seiyaku Kabushiki Kaisha | Long-term stabilized formulations |
CA2337661A1 (en) | 2000-02-29 | 2001-08-29 | Pfizer Products Inc. | Stabilized granulocyte colony stimulating factor |
US6946134B1 (en) | 2000-04-12 | 2005-09-20 | Human Genome Sciences, Inc. | Albumin fusion proteins |
US6926898B2 (en) | 2000-04-12 | 2005-08-09 | Human Genome Sciences, Inc. | Albumin fusion proteins |
AU8260701A (en) | 2000-09-01 | 2002-03-13 | Chugai Pharmaceutical Co Ltd | Solution preparations stabilized over long time |
US8435939B2 (en) | 2000-09-05 | 2013-05-07 | Biokine Therapeutics Ltd. | Polypeptide anti-HIV agent containing the same |
US7507413B2 (en) | 2001-04-12 | 2009-03-24 | Human Genome Sciences, Inc. | Albumin fusion proteins |
ES2500918T3 (es) | 2001-12-21 | 2014-10-01 | Human Genome Sciences, Inc. | Proteínas de fusión de albúmina e interferón beta |
WO2004020462A1 (ja) | 2002-08-27 | 2004-03-11 | Fujii, Nobutaka | Cxcr4拮抗薬およびその用途 |
WO2004075913A1 (ja) | 2003-02-28 | 2004-09-10 | Chugai Seiyaku Kabushiki Kaisha | タンパク質含有安定化製剤 |
DE202006020194U1 (de) | 2006-03-01 | 2007-12-06 | Bioceuticals Arzneimittel Ag | G-CSF-Flüssigformulierung |
EP2094274A4 (en) | 2006-12-21 | 2011-05-11 | Biokine Therapeutics Ltd | T-140 PEPTIDE ANALOGUE WITH CXCR4 SUPERAGONIST ACTIVITY FOR BONE MARROW RECOVERY |
WO2010092571A2 (en) | 2009-02-11 | 2010-08-19 | Yeda Research And Development Co. Ltd. | Short beta-defensin-derived peptides |
CN107412737A (zh) * | 2010-01-19 | 2017-12-01 | 韩美科学株式会社 | 长效g‑csf缀合物的液体制剂 |
EP2399572A1 (en) | 2010-06-22 | 2011-12-28 | Sandoz AG | Long-term storage of non-glycosylated recombinant human G-CSF |
KR20180063881A (ko) | 2015-07-16 | 2018-06-12 | 바이오카인 테라퓨틱스 리미티드 | 암 치료용 조성물 및 방법 |
KR102033920B1 (ko) | 2016-02-23 | 2019-10-18 | 바이오라인알엑스 리미티드 | 급성 골수성 백혈병을 치료하는 방법 |
WO2018138267A1 (en) | 2017-01-27 | 2018-08-02 | Cinfa Biotech S.L. | Method for determining the efficacy of a g-csf containing composition |
JP7549530B2 (ja) * | 2018-05-21 | 2024-09-11 | 中外製薬株式会社 | ガラス容器に封入された凍結乾燥製剤 |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2652636A1 (de) * | 1976-11-19 | 1978-05-24 | Hans Uwe Dr Rer Nat Wolf | Verfahren zur stabilisierung von proteinen und verwandten verbindungen waehrend ihrer reinigung, isolierung und lagerung |
SE451844B (sv) * | 1978-03-20 | 1987-11-02 | Morinaga Milk Industry Co Ltd | Glykoprotein, forfarande for framstellning derav samt terapeutiskt medel innehallande nemnda glykoprotein |
EP0098110B1 (en) * | 1982-06-24 | 1989-10-18 | NIHON CHEMICAL RESEARCH KABUSHIKI KAISHA also known as JAPAN CHEMICAL RESEARCH CO., LTD | Long-acting composition |
JPS60228422A (ja) * | 1984-04-26 | 1985-11-13 | Suntory Ltd | 安定化された生理活性物質製剤 |
JPS61227526A (ja) * | 1984-07-25 | 1986-10-09 | Chugai Pharmaceut Co Ltd | 新規なコロニー刺激因子 |
JPS6191131A (ja) * | 1984-10-09 | 1986-05-09 | Chugai Pharmaceut Co Ltd | 医薬品の吸着防止方法および組成物 |
WO1986004587A1 (en) * | 1985-02-05 | 1986-08-14 | Cetus Corporation | Purification of native colony stimulating factor-1 |
US4810643A (en) * | 1985-08-23 | 1989-03-07 | Kirin- Amgen Inc. | Production of pluripotent granulocyte colony-stimulating factor |
JPH0618778B2 (ja) * | 1985-10-04 | 1994-03-16 | 中外製薬株式会社 | 白血球減少症治療剤 |
-
1987
- 1987-07-08 GR GR871067A patent/GR871067B/el unknown
- 1987-07-10 IT IT67594/87A patent/IT1218927B/it active
- 1987-07-13 NL NL8701640A patent/NL192917C/nl not_active IP Right Cessation
- 1987-07-14 AT AT0177587A patent/AT402259B/de not_active IP Right Cessation
- 1987-07-15 DK DK368387A patent/DK171308B1/da not_active IP Right Cessation
- 1987-07-15 CA CA000542239A patent/CA1297007C/en not_active Expired - Lifetime
- 1987-07-15 BE BE8700787A patent/BE1000253A3/fr not_active IP Right Cessation
- 1987-07-15 AU AU75665/87A patent/AU611856B2/en not_active Expired
- 1987-07-16 CH CH2727/87A patent/CH671157A5/de not_active IP Right Cessation
- 1987-07-16 NO NO872966A patent/NO171828C/no not_active IP Right Cessation
- 1987-07-16 PT PT85343A patent/PT85343B/pt unknown
- 1987-07-17 ES ES8702106A patent/ES2010226A6/es not_active Expired
- 1987-07-17 GB GB8716904A patent/GB2193631B/en not_active Expired - Lifetime
- 1987-07-17 DE DE3723781A patent/DE3723781C2/de not_active Expired - Lifetime
- 1987-07-17 IL IL83220A patent/IL83220A/xx not_active IP Right Cessation
- 1987-07-17 SE SE8702907A patent/SE503312C2/sv not_active IP Right Cessation
- 1987-07-17 IE IE193387A patent/IE60290B1/en not_active IP Right Cessation
- 1987-07-17 YU YU134287A patent/YU47543B/sh unknown
- 1987-07-17 HU HU873268A patent/HU198627B/hu unknown
- 1987-07-17 FR FR878710156A patent/FR2601591B1/fr not_active Expired - Lifetime
- 1987-07-18 KR KR1019870007804A patent/KR930004597B1/ko not_active IP Right Cessation
- 1987-07-18 CN CN87104963A patent/CN1033738C/zh not_active Expired - Lifetime
-
1993
- 1993-05-18 SG SG64393A patent/SG64393G/en unknown
- 1993-07-08 HK HK648/93A patent/HK64893A/xx not_active IP Right Cessation
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SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C15 | Extension of patent right duration from 15 to 20 years for appl. with date before 31.12.1992 and still valid on 11.12.2001 (patent law change 1993) | ||
OR01 | Other related matters | ||
C17 | Cessation of patent right | ||
CX01 | Expiry of patent term |