KR880001294A - 사용하도록 준비된 토라새미드의 주사용액 및 이들의 제조방법 - Google Patents

사용하도록 준비된 토라새미드의 주사용액 및 이들의 제조방법 Download PDF

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KR880001294A
KR880001294A KR1019870007506A KR870007506A KR880001294A KR 880001294 A KR880001294 A KR 880001294A KR 1019870007506 A KR1019870007506 A KR 1019870007506A KR 870007506 A KR870007506 A KR 870007506A KR 880001294 A KR880001294 A KR 880001294A
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solution
torasemide
organic solvent
molecular weight
injection solution
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KR1019870007506A
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KR950010158B1 (ko
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댐버 프리쯔
그루버 베르너
보크 하인리히
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다움, 포우퀘트
뵈링거 만하임 게임베하
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    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/64Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Ink Jet (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pyridine Compounds (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Enzymes And Modification Thereof (AREA)

Abstract

내용 없음

Description

사용하도록 준비된 토라새미드의 주사용액 및 이들의 제조방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (21)

  1. 9.3내지 9.9 pH값을 갖고 0.1 val/l 이하의 완충능력을 갖는 생리학적으로 적합한 알칼리성 완충용액 및 분자량 100내지 1500을 갖는 폴리에틸렌글리콜 분자량 50내지 100을 갖는 폴리프로필렌글리콜, 글리세롤, 프로필렌글리콜, 에탄올 및 프로판올 그룹으로부터 선택된 5내지 20중량%의 유기 용매 및 2내지 40㎎/㎖의 농도로 존재하는 토라세미드를 함유하는 주사용 토라세미드의 수용성 알칼리주사용액.
  2. 제1항에 있어서, 유기용매가 30ppm 이하의 알데히드를 함유함을 특징으로 하는 주사용액.
  3. 제2항에 있어서, 유기용매가 10ppm 이하의 알데히드를 함유함을 특징으로 하는 주사용액.
  4. 상기항중 어느항에 있어서 완충물이 탄산, 인산 글리신산 또는 아르긴산의 나트륨, 칼륨, 또는 암모늄, N-메틸 글루코스아미네이트 또는 다른 아미노산 완충물 및/또는 트리스-(히드록시메틸)-아미노메탄임을 특징으로 하는 주사용액.
  5. 상기항중 어느항에서, 용액은 추가로 생리학적으로 적합한 텐시드 및/또는 환원제를 함유하는 주사용액.
  6. 상기항중 어느항에있어서, 용액은 또한 등장용액 제조용 시약을 함유하는 주사용액.
  7. 상기항중 어느항에있어서, 용액은 적어도 하나의 추가의 활성물질을 함유하는 주사용액.
  8. 제7항에 있어서, 추가의 활성물질이 이뇨제임을 특징으로하는 주사용액.
  9. 제8항에 있어서, 이뇨제가 카레노에이트 및/또는 퓨로세미드임을 특징으로하는 주사용액.
  10. 제7내지 9항중의 어느항에 있어서, 추가의 활성물질이 100㎎/㎖ 이하의 양으로 존재함을 특징으로하는 주사용액.
  11. 제6내지 10항중의 어느항에있어서, 등장농도의 조절용 시약이 염화나트륨, 과당, 유당 또는 포도당임을 특징으로하는 주사용액.
  12. 상기항중의 어느항에있어서, 유기용매가 20내지 600의 분자량을 갖는 폴리에틸렌글리콜임을 특징으로하는 주사용액.
  13. 제12항에 있어서, 폴리에틸렌글리콜이 분자량 400을 갖음을 특징으로하는 주사용액.
  14. 실질적으로 상기에 제시하고, 설명한 바와같은 제1항에 따른 주사용액.
  15. 분자량 100내지 1500을 갖는 폴리에틸렌글리콜, 분자량 50내지 1000을 갖는 폴리프로필렌글리콜, 글리세롤, 프로필렌글리콜, 에탄올 및 프로판올로부터 선택된 유기용매에 토라세미드를 현탁시키고 여기에 알칼리수용액 완충물 및 다른 보조제들을 가하여 용액으로 만들고 산 또는 알칼리를 가하여 pH값을 9.3내지 9.9로 조절하고 용액을 녹지않는 입자들로부터 여과하고 살균처리함을 특징으로하는 제1항에 따른 주사용액의 제조방법.
  16. 제15항에 있어서, 살균처리는 100내지 130℃로 가열하여 수행됨을 특징으로하는 방법.
  17. 제15 또는 16항에있어서, 용액은 질소하에 앰푸울속에 채워지고 저장됨을 특징으로하는 방법.
  18. 제15내지 17항중의 어느항에 있어서 토라세미드는 10㎛ 이하의 입자 크기로 사용됨을 특징으로하는 방법.
  19. 제18항에 있어서, 토라세미드는 2㎛ 이하의 입자 크기로 사용됨을 특징으로하는 방법.
  20. 실질적으로 상기에 제시하였고 설명한 바와같은 제1항에따른 주사용액의 제조방법.
  21. 제15내지 20항중의 어느항에 따른 방법에의해 제조된 제1항에따른 주사용액.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019870007506A 1986-07-12 1987-07-11 사용하도록 준비된 토라세미드의 주사용액 및 이들의 제조방법 KR950010158B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE3623620.9 1986-07-12
DE3623620 1986-07-12
DE19863623620 DE3623620A1 (de) 1986-07-12 1986-07-12 Spritzfertige, waessrige, alkalische injektionsloesungen von torasemid und verfahren zu ihrer herstellung

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KR880001294A true KR880001294A (ko) 1988-04-22
KR950010158B1 KR950010158B1 (ko) 1995-09-11

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KR1019870007506A KR950010158B1 (ko) 1986-07-12 1987-07-11 사용하도록 준비된 토라세미드의 주사용액 및 이들의 제조방법

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US (1) US4861786A (ko)
EP (1) EP0253226B1 (ko)
JP (1) JPS6323818A (ko)
KR (1) KR950010158B1 (ko)
AT (1) ATE53296T1 (ko)
AU (1) AU578562B2 (ko)
CA (1) CA1302278C (ko)
DE (2) DE3623620A1 (ko)
DK (1) DK174624B1 (ko)
ES (1) ES2016306B3 (ko)
FI (1) FI87993C (ko)
GR (1) GR3000534T3 (ko)
NZ (1) NZ221026A (ko)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5486530A (en) * 1991-04-27 1996-01-23 Boehringer Mannheim Gmbh Use of torasemide for the treatment of brain oedemas
DE4126984A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, gut vertraeglichen arzneimitteln fuer infusions- oder injektionszwecke
JP3028171B2 (ja) * 1993-08-31 2000-04-04 日本ピラー工業株式会社 複合ガスケット
US5585401A (en) * 1994-12-09 1996-12-17 The Reents Of The University Of California Method for enhancing outflow of aqueous humor in treatment of glaucoma
US6228873B1 (en) 1994-12-09 2001-05-08 The Regents Of The University Of California Method for enhancing outflow of aqueous humor in treatment of glaucoma
US5763491A (en) * 1994-12-09 1998-06-09 The Regents Of The University Of California Method for enhancing outflow of aqueous humor in treatment of glaucoma
MXPA02001369A (es) 1999-08-11 2005-08-26 Teva Pharma Torasemidas polimorfas.
SK14802002A3 (sk) 2000-03-20 2003-05-02 Teva Pharmaceutical Industries Ltd. Nový spôsob prípravy medziproduktu torsemidu
EP1465596A1 (en) * 2002-01-18 2004-10-13 Control Delivery Systems, Inc. Polymeric gel system for the controlled delivery of codrugs
EP2266590A3 (en) 2002-02-22 2011-04-20 Shire LLC Active agent delivery sytems and methods for protecting and administering active agents
CN100372534C (zh) * 2006-04-20 2008-03-05 南京海辰药业有限公司 托拉塞米冻干制剂及制备方法
US20100053852A1 (en) * 2008-09-02 2010-03-04 Cheng Uei Precision Industry Co., Ltd. Display Device
CN103371967A (zh) * 2012-04-17 2013-10-30 上海禾丰制药有限公司 呋塞米注射液及其制剂工艺
US9884039B2 (en) * 2013-04-05 2018-02-06 Scpharmaceuticals Inc. Pharmaceutical formulations for subcutaneous administration of furosemide
FR3077984B1 (fr) 2018-02-16 2020-02-21 Vetoquinol Sa Composition multiusage de torasemide
WO2020160210A1 (en) 2019-01-31 2020-08-06 Scpharmaceuticals Inc. Concentrated liquid pharmaceutical formulations of furosemide and methods of administering the same
CN110606826B (zh) * 2019-05-23 2021-06-01 上海勋和医药科技有限公司 托拉塞米钠一水合物、其晶型及组合物
CN112168776B (zh) * 2020-10-30 2022-05-03 康普药业股份有限公司 一种低杂质高稳定的托拉塞米注射液和制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE185374C (ko) *
DE30681C (de) * R.W. traylor in Richmond, County of Henrico State of Virginia, V. St. A Gufsform aus Glimmer
DK138974B (da) * 1974-02-19 1978-11-27 Ciba Geigy Ag Fremgangsmåde til fremstilling af vandige oxytetracyclinopløsninger til parenteral, peroral og lokal anvendelse.
DE2950832C2 (de) * 1979-12-18 1983-03-17 Hoechst Ag, 6000 Frankfurt Spritzfertige injizierbare wäßrige Lösungen der Alkalisalze von Canrenoinsäure und Furosemid
DE3241765A1 (de) * 1982-11-11 1984-05-17 Henning Berlin Gmbh Chemie- Und Pharmawerk, 1000 Berlin Stabile zubereitungen fuer injektionszwecke enthaltend hydrochlorothiazid
DE3446873A1 (de) * 1984-12-21 1986-07-10 Merckle Gmbh Fluessige diclofenac-zubereitungen
DE3529529A1 (de) * 1985-08-17 1987-02-19 Boehringer Mannheim Gmbh Verfahren zur herstellung einer stabilen modifikation von torasemid

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CA1302278C (en) 1992-06-02
FI873059A0 (fi) 1987-07-10
DE3763010D1 (de) 1990-07-12
DE3623620C2 (ko) 1991-02-28
DE3623620A1 (de) 1988-01-21
ES2016306B3 (es) 1990-11-01
DK360287A (da) 1988-01-13
ATE53296T1 (de) 1990-06-15
EP0253226B1 (de) 1990-06-06
DK360287D0 (da) 1987-07-10
AU578562B2 (en) 1988-10-27
FI87993C (fi) 1993-03-25
GR3000534T3 (en) 1991-07-31
FI87993B (fi) 1992-12-15
US4861786A (en) 1989-08-29
FI873059A (fi) 1988-01-13
NZ221026A (en) 1989-09-27
KR950010158B1 (ko) 1995-09-11
EP0253226A1 (de) 1988-01-20
JPS6323818A (ja) 1988-02-01
JPH055810B2 (ko) 1993-01-25
AU7535587A (en) 1988-01-14
DK174624B1 (da) 2003-07-28

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