CN102488886B - 一种低杂质含量的卡泊芬净制剂及其制备方法和用途 - Google Patents

一种低杂质含量的卡泊芬净制剂及其制备方法和用途 Download PDF

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CN102488886B
CN102488886B CN201110433680.2A CN201110433680A CN102488886B CN 102488886 B CN102488886 B CN 102488886B CN 201110433680 A CN201110433680 A CN 201110433680A CN 102488886 B CN102488886 B CN 102488886B
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caspofungin
formula
shelf temperature
pharmaceutical composition
drying
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Chinese (zh)
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CN102488886A (zh
Inventor
洪云海
薛颖
沙丽新
季晓铭
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Shanghai Techwell Biopharmaceutical Co Ltd
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Shanghai Techwell Biopharmaceutical Co Ltd
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Priority to CN201110433680.2A priority Critical patent/CN102488886B/zh
Priority to CN201310274802.7A priority patent/CN103315969B/zh
Publication of CN102488886A publication Critical patent/CN102488886A/zh
Priority to IN892KON2014 priority patent/IN2014KN00892A/en
Priority to PCT/CN2012/081956 priority patent/WO2013044789A1/zh
Priority to DE112012003995.5T priority patent/DE112012003995T5/de
Priority to KR1020147011190A priority patent/KR101720396B1/ko
Priority to ES201490033A priority patent/ES2495615B1/es
Priority to US14/346,275 priority patent/US9149435B2/en
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Publication of CN102488886B publication Critical patent/CN102488886B/zh
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    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/50—Cyclic peptides containing at least one abnormal peptide link
    • C07K7/54—Cyclic peptides containing at least one abnormal peptide link with at least one abnormal peptide link in the ring
    • C07K7/56—Cyclic peptides containing at least one abnormal peptide link with at least one abnormal peptide link in the ring the cyclisation not occurring through 2,4-diamino-butanoic acid

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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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201110433680.2A 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途 Active CN102488886B (zh)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CN201110433680.2A CN102488886B (zh) 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN201310274802.7A CN103315969B (zh) 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
DE112012003995.5T DE112012003995T5 (de) 2011-09-26 2012-09-25 Caspofunginpräparat mit geringem Verunreinigungsgehalt, Verfahren zu seiner Herstellung und seine Verwendung
PCT/CN2012/081956 WO2013044789A1 (zh) 2011-09-26 2012-09-25 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
IN892KON2014 IN2014KN00892A (enExample) 2011-09-26 2012-09-25
KR1020147011190A KR101720396B1 (ko) 2011-09-26 2012-09-25 불순물 함량이 낮은 카스포펀진 제제 및 그 제조방법과 용도
ES201490033A ES2495615B1 (es) 2011-09-26 2012-09-25 Preparación de caspofungina de bajo contenido de impurezas, método para preparar la misma, y uso de la misma
US14/346,275 US9149435B2 (en) 2011-09-26 2012-09-25 Low impurity content caspofungin preparation, method for preparing same, and use thereof

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201110288753.3 2011-09-26
CN201110288753 2011-09-26
CN201110433680.2A CN102488886B (zh) 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途

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CN201310274802.7A Division CN103315969B (zh) 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途

Publications (2)

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CN102488886A CN102488886A (zh) 2012-06-13
CN102488886B true CN102488886B (zh) 2014-03-26

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CN201310274802.7A Expired - Fee Related CN103315969B (zh) 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途

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Country Status (7)

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US (1) US9149435B2 (enExample)
KR (1) KR101720396B1 (enExample)
CN (2) CN102488886B (enExample)
DE (1) DE112012003995T5 (enExample)
ES (1) ES2495615B1 (enExample)
IN (1) IN2014KN00892A (enExample)
WO (1) WO2013044789A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102488889B (zh) 2011-09-26 2014-01-22 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN102488886B (zh) 2011-09-26 2014-03-26 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN103212058A (zh) * 2012-01-18 2013-07-24 江苏恒瑞医药股份有限公司 含有抗真菌药物和乳酸盐缓冲剂的组合物
CN103539841A (zh) * 2012-07-12 2014-01-29 重庆乾泰生物医药有限公司 一种环己肽类化合物及其盐的分离纯化方法
KR20140123782A (ko) * 2013-04-15 2014-10-23 에스케이케미칼주식회사 카스포펀진 및 완충제를 포함하는 안정성이 개선된 약학적 조성물
CN106860856B (zh) * 2015-12-14 2019-05-31 山东新时代药业有限公司 一种含有阿尼芬净的冻干粉及制备方法
CN108760937B (zh) * 2018-07-27 2020-12-29 杭州华东医药集团新药研究院有限公司 醋酸卡泊芬净中残留乙二胺的测定及其应用
CN109394707A (zh) * 2018-12-26 2019-03-01 四川制药制剂有限公司 一种注射用醋酸卡泊芬净的制造方法
CN109568275B (zh) * 2019-01-10 2021-08-27 杭州华东医药集团新药研究院有限公司 一种含醋酸卡泊芬净的冻干组合物及其制备方法

Citations (5)

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CN1222082A (zh) * 1996-04-19 1999-07-07 麦克公司 含有抗真菌剂和乙酸盐缓冲液的组合物
CN1345229A (zh) * 1999-03-03 2002-04-17 伊莱利利公司 含有成胶束表面活性剂的棘白菌素药物制剂
CN101516387A (zh) * 2006-07-26 2009-08-26 桑多斯股份公司 卡泊芬净制剂
CN102153616A (zh) * 2010-12-27 2011-08-17 浙江海正药业股份有限公司 一种环己肽类化合物及其盐的分离纯化方法
CN102219832A (zh) * 2010-04-15 2011-10-19 上海天伟生物制药有限公司 一种氮杂环六肽或其盐的纯化方法

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US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
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CA2433652A1 (en) * 2001-01-09 2002-07-18 Merck & Co., Inc. Active metabolite of antifungal compound
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US20100137197A1 (en) * 2007-06-26 2010-06-03 Sachin Mittal Lyophilized anti-fungal composition
WO2009142761A1 (en) * 2008-05-21 2009-11-26 Teva Gyogyszergyar Zartkoruen Mukodo Reszvenytarsasag Caspofungin bo free of caspofungin co
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KR20110011704A (ko) * 2008-06-25 2011-02-08 테바 기오기스제르갸르 자르트쾨렌 뮈쾨되 레스즈베니타르사사그 카스포펀진 불순물 ａ를 함유하지 않는 카스포펀진
CN102488886B (zh) * 2011-09-26 2014-03-26 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN102488889B (zh) * 2011-09-26 2014-01-22 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1222082A (zh) * 1996-04-19 1999-07-07 麦克公司 含有抗真菌剂和乙酸盐缓冲液的组合物
CN1345229A (zh) * 1999-03-03 2002-04-17 伊莱利利公司 含有成胶束表面活性剂的棘白菌素药物制剂
CN101516387A (zh) * 2006-07-26 2009-08-26 桑多斯股份公司 卡泊芬净制剂
CN102219832A (zh) * 2010-04-15 2011-10-19 上海天伟生物制药有限公司 一种氮杂环六肽或其盐的纯化方法
CN102153616A (zh) * 2010-12-27 2011-08-17 浙江海正药业股份有限公司 一种环己肽类化合物及其盐的分离纯化方法

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Publication number Publication date
ES2495615R1 (es) 2014-11-12
CN103315969A (zh) 2013-09-25
DE112012003995T5 (de) 2014-08-21
US20140228280A1 (en) 2014-08-14
CN102488886A (zh) 2012-06-13
WO2013044789A1 (zh) 2013-04-04
CN103315969B (zh) 2016-05-18
KR101720396B1 (ko) 2017-03-27
KR20140069273A (ko) 2014-06-09
ES2495615B1 (es) 2015-08-19
US9149435B2 (en) 2015-10-06
IN2014KN00892A (enExample) 2015-10-09
ES2495615A2 (es) 2014-09-17

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