CN106061467B - 用于产生去甲肾上腺素的稳定低浓度、可注射溶液的方法 - Google Patents

用于产生去甲肾上腺素的稳定低浓度、可注射溶液的方法 Download PDF

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Publication number
CN106061467B
CN106061467B CN201580010039.4A CN201580010039A CN106061467B CN 106061467 B CN106061467 B CN 106061467B CN 201580010039 A CN201580010039 A CN 201580010039A CN 106061467 B CN106061467 B CN 106061467B
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solution
noradrenaline
norepinephrine
low concentration
stable
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Chinese (zh)
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CN106061467A (zh
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奥古斯托·米提蒂利
伊丽莎白·多纳蒂
尼古拉·卡龙佐罗
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Sintetica SA
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Sintetica SA
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • 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
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04Heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05Living organisms or biological materials

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
CN201580010039.4A 2014-02-27 2015-02-26 用于产生去甲肾上腺素的稳定低浓度、可注射溶液的方法 Active CN106061467B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITMI20140306 2014-02-27
ITMI2014A000306 2014-02-27
PCT/EP2015/054021 WO2015128418A1 (en) 2014-02-27 2015-02-26 Process for producing a stable low concentration, injectable solution of noradrenaline

Publications (2)

Publication Number Publication Date
CN106061467A CN106061467A (zh) 2016-10-26
CN106061467B true CN106061467B (zh) 2021-02-05

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CN201580010039.4A Active CN106061467B (zh) 2014-02-27 2015-02-26 用于产生去甲肾上腺素的稳定低浓度、可注射溶液的方法

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US (4) USRE49422E1 (enExample)
EP (1) EP3110399B1 (enExample)
JP (1) JP6635927B2 (enExample)
KR (1) KR102306706B1 (enExample)
CN (1) CN106061467B (enExample)
AP (1) AP2016009467A0 (enExample)
AR (1) AR101148A1 (enExample)
AU (1) AU2015222150B2 (enExample)
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SM (1) SMT201800239T1 (enExample)
SV (1) SV2016005265A (enExample)
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UA (1) UA118043C2 (enExample)
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WO (1) WO2015128418A1 (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UY35988A (es) 2014-02-27 2015-09-30 Sint Sa Proceso para la producción de una solución inyectable de noradrenalina de baja concentración
PL2990031T3 (pl) 2014-08-28 2020-05-18 Sun Pharmaceutical Industries Ltd Pozajelitowa postać norepinefryny
CA3051467C (en) 2017-01-30 2022-11-29 Nevakar, Inc Norepinephrine compositions and methods therefor
US20250177328A1 (en) 2017-01-30 2025-06-05 Nevakar Injectables Inc. Norepinephrine compositions and methods therefor
CN109394683A (zh) * 2018-12-07 2019-03-01 远大医药(中国)有限公司 一种重酒石酸去甲肾上腺素注射液的制备方法
US10888534B2 (en) * 2019-04-26 2021-01-12 InfoRLife SA Storage stable ready-to-use norepinephrine aqueous solutions in flexible plastic bags
CA3174640A1 (en) * 2020-03-06 2021-09-10 Baxter International Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
PL4051251T3 (pl) * 2020-10-21 2024-04-08 Sintetica S.A. Stabilne, wolne od antyoksydantów roztwory noradrenaliny do wstrzykiwania
US20220117843A1 (en) * 2020-10-21 2022-04-21 Sintetica S.A. Ready to use, noradrenaline drip bags, having low subvisible particle counts
US11331266B1 (en) * 2020-10-29 2022-05-17 Medefil, Inc. Antioxidant free, norepinephrine bitartrate injection in amber glass vials
US20220233473A1 (en) * 2021-01-28 2022-07-28 Cumberland Pharmaceuticals Inc. Injectable solution of norepinephrine
AR124867A1 (es) 2021-02-15 2023-05-10 Sintetica S A Un medicamento en una bolsa de goteo intravenoso plegable lista para usar herméticamente sellada, método para hacer dicho medicamento y medicamento elaborado mediante dicho método
CN116327697A (zh) * 2023-04-17 2023-06-27 福安药业集团庆余堂制药有限公司 一种重酒石酸去甲肾上腺素注射液及其制剂工艺

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102497882A (zh) * 2009-06-04 2012-06-13 Alk股份公司 包含至少一种肾上腺素能化合物的稳定化组合物

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FR2832063B1 (fr) * 2001-11-15 2004-08-27 Aguettant Lab Procede de production de solutions stables de substances phenoliques et les solutions en resultant
BR0311965A (pt) 2002-06-20 2005-03-29 Novalar Pharmaceutical Inc Formulações estabilizadas de antagonistas de receptores alfa adrenérgicos e os seus usos
US20040005401A1 (en) 2002-07-05 2004-01-08 Robert Becker Method for applying a washcoat to suppport bodies
US7078876B2 (en) 2003-07-07 2006-07-18 Pentadyne Power Corporation Feedforward controller for synchronous reluctance machines
FR2880807B1 (fr) * 2005-01-19 2007-04-13 Aguettant Sa Lab Composition pharmaceutique injectable
US7465489B2 (en) 2005-11-15 2008-12-16 Poly-Med, Inc. Inorganic-organic melted-extruded hybrid filaments and medical applications thereof
FR2894154B1 (fr) 2005-12-06 2008-03-14 Pharmatop Scr Nouveau procede de stabilisation de substances minerales ou organiques sensibles a l'oxydation.
EP2096433A1 (de) 2008-02-26 2009-09-02 Siemens Aktiengesellschaft Vorrichtung zur zerstörungsfreien Materialprüfung eines Prüfgegenstands mit Ultraschallwellen
US8419689B2 (en) 2008-09-30 2013-04-16 Covidien Lp Enclosing package for medical port and cover
US8628805B2 (en) 2009-06-04 2014-01-14 Alk Ag Stabilized composition comprising at least one adrenergic compound
FR2963237B1 (fr) 2010-07-28 2013-05-17 Aguettant Lab Nouvelle composition pharmaceutique utile pour prevenir ou traiter l'hypotension arterielle peroperatoire chez l'etre humain
CN102525895B (zh) 2012-01-04 2013-11-06 上海禾丰制药有限公司 重酒石酸去甲肾上腺素注射液及其制剂工艺
UY35988A (es) 2014-02-27 2015-09-30 Sint Sa Proceso para la producción de una solución inyectable de noradrenalina de baja concentración
US20160005871A1 (en) 2014-07-04 2016-01-07 Semiconductor Energy Laboratory Co., Ltd. Semiconductor device
CA3051467C (en) 2017-01-30 2022-11-29 Nevakar, Inc Norepinephrine compositions and methods therefor

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US20170049720A1 (en) 2017-02-23
PL3110399T3 (pl) 2018-07-31
KR102306706B1 (ko) 2021-09-30
DOP2016000210A (es) 2016-11-30
AR101148A1 (es) 2016-11-30
USRE49443E1 (en) 2023-03-07
TWI673065B (zh) 2019-10-01
ECSP16065957A (es) 2017-01-31
MD4628B1 (ro) 2019-05-31
EP3110399A1 (en) 2017-01-04
MA39200A1 (fr) 2017-06-30
HUE038738T2 (hu) 2018-11-28
CL2016002073A1 (es) 2017-02-10
EA201691734A1 (ru) 2016-12-30
EA031444B1 (ru) 2019-01-31
USRE49555E1 (en) 2023-06-20
LT3110399T (lt) 2018-04-25
GEP20186829B (en) 2018-02-26
SMT201800239T1 (it) 2018-07-17
MY179942A (en) 2020-11-19
PH12016501703B1 (en) 2019-08-23
BR112016019804A2 (enExample) 2017-08-15
AU2015222150A1 (en) 2016-10-13
CA2940347C (en) 2021-04-27
ME03004B (me) 2018-10-20
MD4628C1 (ro) 2019-12-31
JP2017506632A (ja) 2017-03-09
AP2016009467A0 (en) 2016-09-30
CN106061467A (zh) 2016-10-26
CA2940347A1 (en) 2015-09-03
WO2015128418A1 (en) 2015-09-03
SV2016005265A (es) 2017-01-18
US10251848B2 (en) 2019-04-09
MX2016011148A (es) 2016-12-09
PH12016501703A1 (en) 2016-12-19
JO3552B1 (ar) 2020-07-05
MX367148B (es) 2019-08-07
KR20160122264A (ko) 2016-10-21
BR112016019804B1 (pt) 2022-03-03
EP3110399B1 (en) 2018-01-10
ES2663817T3 (es) 2018-04-17
SG11201607094WA (en) 2016-09-29
JP6635927B2 (ja) 2020-01-29
SI3110399T1 (en) 2018-05-31
AU2015222150B2 (en) 2019-12-05
HRP20180541T1 (hr) 2018-05-04
CR20160420A (es) 2016-12-14
RS57044B1 (sr) 2018-05-31
DK3110399T3 (en) 2018-04-09
MD20160103A2 (ro) 2017-01-31
UY35988A (es) 2015-09-30
TW201620499A (zh) 2016-06-16
UA118043C2 (uk) 2018-11-12
CY1120125T1 (el) 2018-12-12
PE20161375A1 (es) 2017-01-05
IL247501A0 (en) 2016-11-30
IL247501B (en) 2020-05-31
NI201600118A (es) 2016-10-03
USRE49422E1 (en) 2023-02-21
PT3110399T (pt) 2018-04-19

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