CN107427512A - 一种曲贝替定的可注射胃肠外用药物组合物及其制备方法 - Google Patents

一种曲贝替定的可注射胃肠外用药物组合物及其制备方法 Download PDF

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CN107427512A
CN107427512A CN201780000885.7A CN201780000885A CN107427512A CN 107427512 A CN107427512 A CN 107427512A CN 201780000885 A CN201780000885 A CN 201780000885A CN 107427512 A CN107427512 A CN 107427512A
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excipient
tributidine
glucose
dextran
composition according
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CN201780000885.7A
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CN107427512B (zh
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王立坤
孙琼
徐晨
殷蓉
刘凯
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Jiangsu Hengrui Medicine Co Ltd
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Jiangsu Hengrui Medicine Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4995—Pyrazines or piperazines forming part of bridged ring systems
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; 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
    • A61K9/0012—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
    • A61K9/08—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
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

本发明涉及一种曲贝替定的可注射胃肠外用药物组合物及其制备方法。具体而言，所述组合物包含曲贝替定和第一赋形剂，所述第一赋形剂选自单糖或多元醇的一种或几种。本发明的制剂质量稳定，适用于工业化大生产。

Description

PCT国内申请，说明书已公开。

Claims (19)

  1. PCT国内申请，权利要求书已公开。
CN201780000885.7A 2016-02-04 2017-01-23 一种曲贝替定的可注射胃肠外用药物组合物及其制备方法 Withdrawn - After Issue CN107427512B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201610081052 2016-02-04
CN2016100810525 2016-02-04
PCT/CN2017/072220 WO2017133544A1 (zh) 2016-02-04 2017-01-23 一种曲贝替定的可注射胃肠外用药物组合物及其制备方法

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CN107427512A true CN107427512A (zh) 2017-12-01
CN107427512B CN107427512B (zh) 2021-10-08

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US (1) US10610529B2 (zh)
EP (1) EP3412293A4 (zh)
JP (1) JP2019504061A (zh)
KR (1) KR20180103965A (zh)
CN (1) CN107427512B (zh)
AU (1) AU2017215603A1 (zh)
BR (1) BR112018015118A2 (zh)
CA (1) CA3011527A1 (zh)
HK (1) HK1244713A1 (zh)
MX (1) MX2018009088A (zh)
RU (1) RU2738741C2 (zh)
TW (1) TWI720117B (zh)
WO (1) WO2017133544A1 (zh)
ZA (1) ZA201804964B (zh)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108276408B (zh) * 2018-04-19 2020-09-29 上海皓元医药股份有限公司 一种曲贝替定的中间体及其制备方法和用途
US20210169873A1 (en) * 2019-10-21 2021-06-10 RK Pharma Solutions LLC Storage-stable ready-to-use injectable formulations of Trabectedin
WO2021209545A1 (en) 2020-04-15 2021-10-21 Ever Valinject Gmbh Composition comprising trabectedin and an amino acid
US20230226051A1 (en) * 2022-01-20 2023-07-20 Extrovis Ag Trabectedin composition

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1360503A (zh) * 1999-05-13 2002-07-24 法马马有限公司 用于治疗癌症的海鞘素743的组合物和用途
CN1823794A (zh) * 2004-10-29 2006-08-30 法马马私人股份有限公司 制剂

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1067933B1 (en) * 1998-04-06 2007-08-15 The Board Of Trustees Of The University Of Illinois Semi-synthetic ecteinascidins
GB201217439D0 (en) * 2012-09-28 2012-11-14 Topotarget As Combination therapy

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1360503A (zh) * 1999-05-13 2002-07-24 法马马有限公司 用于治疗癌症的海鞘素743的组合物和用途
CN1823794A (zh) * 2004-10-29 2006-08-30 法马马私人股份有限公司 制剂

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Publication number Publication date
RU2738741C2 (ru) 2020-12-16
TW201728327A (zh) 2017-08-16
ZA201804964B (en) 2019-12-18
CA3011527A1 (en) 2017-08-10
RU2018128913A (ru) 2020-03-04
RU2018128913A3 (zh) 2020-06-23
TWI720117B (zh) 2021-03-01
WO2017133544A1 (zh) 2017-08-10
JP2019504061A (ja) 2019-02-14
US20190030028A1 (en) 2019-01-31
EP3412293A4 (en) 2019-10-16
EP3412293A1 (en) 2018-12-12
MX2018009088A (es) 2018-09-03
AU2017215603A1 (en) 2018-08-09
US10610529B2 (en) 2020-04-07
BR112018015118A2 (zh) 2018-12-18
KR20180103965A (ko) 2018-09-19
CN107427512B (zh) 2021-10-08
HK1244713A1 (zh) 2018-08-17

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