CN109069502A - 含盐皮质激素受体拮抗剂的药物组合物及其用途 - Google Patents

含盐皮质激素受体拮抗剂的药物组合物及其用途 Download PDF

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CN109069502A
CN109069502A CN201780006183.XA CN201780006183A CN109069502A CN 109069502 A CN109069502 A CN 109069502A CN 201780006183 A CN201780006183 A CN 201780006183A CN 109069502 A CN109069502 A CN 109069502A
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compound
pharmaceutical composition
daily dose
optionally
patients
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CN109069502B (zh
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黄振华
郭小翠
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Novo Nordisk AS
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KBP Biosciences Co Ltd
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    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/20Organic 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Abstract

一种含盐皮质激素受体拮抗剂的药物组合物及其用途。药物组合物口服给药于需要其治疗的慢性肾病患者,其有效且安全的AUC范围为188ng*h/mL至3173ng*h/mL,其在哺乳动物中的生物利用度≥50%。药物组合物以日剂量为0.1mg‑1.0mg给药用于治疗慢性肾病时AUC控制在安全有效的范围内。

Description

PCT国内申请,说明书已公开。

Claims (20)

  1. PCT国内申请,权利要求书已公开。
CN201780006183.XA 2016-09-24 2017-09-22 含盐皮质激素受体拮抗剂的药物组合物及其用途 Active CN109069502B (zh)

Applications Claiming Priority (3)

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CN2016108491424 2016-09-24
CN201610849142 2016-09-24
PCT/CN2017/102969 WO2018054357A1 (zh) 2016-09-24 2017-09-22 含盐皮质激素受体拮抗剂的药物组合物及其用途

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CN109069502A true CN109069502A (zh) 2018-12-21
CN109069502B CN109069502B (zh) 2021-08-06

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US (2) US11806344B2 (zh)
EP (1) EP3517113A4 (zh)
JP (2) JP7090599B2 (zh)
KR (1) KR102226516B1 (zh)
CN (1) CN109069502B (zh)
AU (1) AU2017329549B2 (zh)
BR (1) BR112019005214A2 (zh)
CA (1) CA3037588C (zh)
CL (1) CL2019000753A1 (zh)
CO (1) CO2019003808A2 (zh)
CR (1) CR20190203A (zh)
CU (1) CU24569B1 (zh)
DO (1) DOP2019000072A (zh)
EA (1) EA201990668A1 (zh)
EC (1) ECSP19027578A (zh)
HK (1) HK1258622A1 (zh)
IL (1) IL265560B (zh)
MA (1) MA45202B1 (zh)
MX (1) MX2019003339A (zh)
MY (1) MY195054A (zh)
NZ (1) NZ751901A (zh)
PE (1) PE20190608A1 (zh)
PH (1) PH12019500516A1 (zh)
RU (2) RU2750667C2 (zh)
SG (1) SG10201912389WA (zh)
TN (1) TN2019000063A1 (zh)
TW (2) TWI780488B (zh)
UA (1) UA123464C2 (zh)
WO (1) WO2018054357A1 (zh)
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116492336A (zh) * 2023-04-04 2023-07-28 迪沙药业集团有限公司 一种坎地沙坦酯药物组合物

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109069502B (zh) 2016-09-24 2021-08-06 山东亨利医药科技有限责任公司 含盐皮质激素受体拮抗剂的药物组合物及其用途
CN113425683B (zh) * 2021-08-19 2022-09-20 谢彩华 一种三氮脒缓释注射剂及其制备方法

Citations (2)

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WO2012022121A1 (zh) * 2010-08-18 2012-02-23 山东轩竹医药科技有限公司 作为盐皮质激素受体拮抗剂的并环类化合物
WO2014094664A1 (zh) * 2012-12-22 2014-06-26 山东亨利医药科技有限责任公司 作为盐皮质激素受体拮抗剂的化合物的晶型及其制备方法

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HUP0700395A2 (en) 2007-06-07 2009-03-02 Sanofi Aventis Substituted [1,2,4] triazolo [1,5-a] quinolines, process for their preparation, pharmaceutical compositions thereof, and intermediates
TWI431010B (zh) * 2007-12-19 2014-03-21 Lilly Co Eli 礦皮質素受體拮抗劑及使用方法
EP3251660B1 (en) * 2010-02-25 2019-10-16 Bristol-Myers Squibb Holdings Ireland Unlimited Company Apixaban formulations
HUE034890T2 (hu) * 2010-10-29 2018-03-28 Algiax Pharmaceuticals Gmbh Malononitrilaminok alkalmazása neuropathiás fájdalomban
CN109069502B (zh) 2016-09-24 2021-08-06 山东亨利医药科技有限责任公司 含盐皮质激素受体拮抗剂的药物组合物及其用途

Patent Citations (2)

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WO2012022121A1 (zh) * 2010-08-18 2012-02-23 山东轩竹医药科技有限公司 作为盐皮质激素受体拮抗剂的并环类化合物
WO2014094664A1 (zh) * 2012-12-22 2014-06-26 山东亨利医药科技有限责任公司 作为盐皮质激素受体拮抗剂的化合物的晶型及其制备方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116492336A (zh) * 2023-04-04 2023-07-28 迪沙药业集团有限公司 一种坎地沙坦酯药物组合物

Also Published As

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TWI780488B (zh) 2022-10-11
EA201990668A1 (ru) 2019-10-31
TN2019000063A1 (en) 2020-07-15
IL265560B (en) 2022-07-01
SG10201912389WA (en) 2020-02-27
RU2020120876A (ru) 2020-08-26
AU2017329549B2 (en) 2020-05-14
NZ751901A (en) 2021-07-30
MA45202A1 (fr) 2020-11-30
JP2022037044A (ja) 2022-03-08
DOP2019000072A (es) 2019-06-16
EP3517113A1 (en) 2019-07-31
CN109069502B (zh) 2021-08-06
MA45202B1 (fr) 2022-04-29
KR102226516B1 (ko) 2021-03-12
US20190201390A1 (en) 2019-07-04
CA3037588C (en) 2022-07-12
MX2019003339A (es) 2019-06-03
BR112019005214A2 (pt) 2019-06-11
JP7090599B2 (ja) 2022-06-24
IL265560A (en) 2019-05-30
PH12019500516A1 (en) 2020-02-24
AU2017329549A1 (en) 2019-04-11
ZA201901740B (en) 2019-10-30
CA3037588A1 (en) 2018-03-29
UA123464C2 (uk) 2021-04-07
MY195054A (en) 2023-01-05
TW201813645A (zh) 2018-04-16
RU2725153C1 (ru) 2020-06-30
CL2019000753A1 (es) 2019-07-19
RU2020120876A3 (zh) 2020-12-28
TW202100156A (zh) 2021-01-01
US20240016796A1 (en) 2024-01-18
TWI715806B (zh) 2021-01-11
JP2019532939A (ja) 2019-11-14
KR20190057323A (ko) 2019-05-28
HK1258622A1 (zh) 2019-11-15
EP3517113A4 (en) 2020-07-08
WO2018054357A1 (zh) 2018-03-29
PE20190608A1 (es) 2019-04-23
CO2019003808A2 (es) 2019-04-30
CU24569B1 (es) 2022-01-13
US11806344B2 (en) 2023-11-07
CU20190023A7 (es) 2019-11-04
RU2750667C2 (ru) 2021-06-30
ECSP19027578A (es) 2019-07-31
CR20190203A (es) 2019-06-26

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