KR910016340A - 안정화된 고나도트로핀을 함유하는 제제 - Google Patents

안정화된 고나도트로핀을 함유하는 제제 Download PDF

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KR910016340A
KR910016340A KR1019910004303A KR910004303A KR910016340A KR 910016340 A KR910016340 A KR 910016340A KR 1019910004303 A KR1019910004303 A KR 1019910004303A KR 910004303 A KR910004303 A KR 910004303A KR 910016340 A KR910016340 A KR 910016340A
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gonadotropin
stabilized
stabilizer
lyophilisate
dicarboxylate
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KR1019910004303A
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KR100221123B1 (ko
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레오 조안스 드메르 안드레아
아리에드 루이터 마리누스
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에프.쥐.엠.헤르만스·에이.쥐.제이.베르미렌
악조 엔. 브이
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    • 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
    • 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
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Peptides Or Proteins (AREA)

Abstract

내용 없음

Description

안정화된 고나도트로핀을 함유하는 제제
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 60℃에서 다양한 안정제를 1달간 사용한 후의 조환 FSH활성도의 회수량에 대한 이온세기(x1000)의 상관관계를 보여주는 그래프이다. 제2도는 HCG활성도의 회수율에 대한 시트레이트/프로테인 비(중량/중량)의 효과를 보여주는 그래프이다.

Claims (9)

  1. 다카르복실산염 안정제와 함께 동결건조물중의 상기 안정제의 양에 의해 안정화될 수 있는 고나도트로핀을 포함하는 안정화된 고나도트로핀 함유 동결건조물.
  2. 제1항에 있어서, 상기 디카르복실산염 안정제 중량의 3내지 50배분량의 비-환원당을 부가로 포함하는 안정화된 고나도트로핀 함유동결건조물.
  3. 제1항에 있어서, 비이온성 계면활성제를 부가로 포함하는 안정화된 고나도트로핀 함유 동결건조물.
  4. 제3항에 있어서, 상기 고나도트로핀이 황체형성 호르몬, 인체 난막호르몬, 난포자극 호르몬 또는 그들의 혼합물로 구성되는 군으로부터 선택되는 안정한 고나도트로핀 함유 동결건조물.
  5. 제4항에 있어서, 상기 디카르복실산 염 안정제가 시트르산, 타르타르산 또는 아스파르트산염인 안정한 고나도트로핀 함유 동결건조물.
  6. 제2항에 있어서, 상기 비환원당이 상기 디카르복실산염 안정제 중량의 3배 분량이 존재하는 안정화된 고나도트로핀 함유 동결건조물.
  7. 제6항에 있어서, 상기 디카르복실산 염 안정제에 의해 안정화될 수 있는 제2의 고나도트로핀을 부가로 함유하는 안정한 고나도트로핀 함유 동결건조물.
  8. 고나도트로핀1중량부, 및 상기 고나도트로핀과 관계된 디카르복실산염 안정제 200내지 10,000중량부를 포함하는 안정화된 고나도트로핀 함유 동결건조물.
  9. 수성용액중에, 적어도 한종류의 고나도트로핀과 상기 용액의 이온세기를 0.050 내지 0.350로 조정할 수 있는 분량의 디카르복실산염을 혼합하고, 상기 혼합물에 디카르복실산염 중량의 약 3배 내지 50배 분량의 비환원당을 용해하고, 상기 혼합물을 -35℃이상의 온도로 동결건조시켜서 안정화된 고나도트로핀 동결건조물을 형성시키는 것으로 구성되는 안정화된 고나도트로핀 동결건조물의 제조방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019910004303A 1990-03-20 1991-03-19 안정화된 고나도트로핀을 함유하는 제제 KR100221123B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP90200665 1990-03-20
EP90.200665.9 1990-03-20

Publications (2)

Publication Number Publication Date
KR910016340A true KR910016340A (ko) 1991-11-05
KR100221123B1 KR100221123B1 (ko) 1999-09-15

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KR1019910004303A KR100221123B1 (ko) 1990-03-20 1991-03-19 안정화된 고나도트로핀을 함유하는 제제

Country Status (16)

Country Link
EP (1) EP0448146B1 (ko)
JP (1) JP3031570B2 (ko)
KR (1) KR100221123B1 (ko)
AT (1) ATE107172T1 (ko)
AU (1) AU631730B2 (ko)
CA (1) CA2037884C (ko)
DE (1) DE69102465T2 (ko)
DK (1) DK0448146T3 (ko)
ES (1) ES2057731T3 (ko)
FI (1) FI101194B (ko)
HK (1) HK1002494A1 (ko)
ID (1) ID905B (ko)
IE (1) IE64738B1 (ko)
NZ (1) NZ237458A (ko)
PT (1) PT97074B (ko)
ZA (1) ZA911659B (ko)

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JP4165878B2 (ja) * 1993-06-03 2008-10-15 株式会社林原生物化学研究所 トレハロース遊離酵素とその製造方法並びに用途
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CN101842083B (zh) * 2007-11-01 2012-11-14 默克雪兰诺有限公司 Lh液体制剂
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UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
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Also Published As

Publication number Publication date
PT97074B (pt) 1998-10-30
CA2037884C (en) 2003-10-21
NZ237458A (en) 1992-02-25
EP0448146B1 (en) 1994-06-15
PT97074A (pt) 1991-10-31
JP3031570B2 (ja) 2000-04-10
DK0448146T3 (da) 1994-10-24
FI911309A (fi) 1991-09-21
HK1002494A1 (en) 1998-08-28
DE69102465T2 (de) 1995-03-02
ZA911659B (en) 1991-12-24
KR100221123B1 (ko) 1999-09-15
CA2037884A1 (en) 1991-09-21
FI101194B1 (fi) 1998-05-15
ID905B (id) 1996-09-10
IE910732A1 (en) 1991-09-25
ES2057731T3 (es) 1994-10-16
EP0448146A1 (en) 1991-09-25
FI911309A0 (fi) 1991-03-18
DE69102465D1 (de) 1994-07-21
FI101194B (fi) 1998-05-15
AU7362391A (en) 1991-09-26
IE64738B1 (en) 1995-09-06
ATE107172T1 (de) 1994-07-15
JPH04217630A (ja) 1992-08-07
AU631730B2 (en) 1992-12-03

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