CN111902129A - 减少明胶中内毒素的方法 - Google Patents

减少明胶中内毒素的方法 Download PDF

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Publication number
CN111902129A
CN111902129A CN201980017710.6A CN201980017710A CN111902129A CN 111902129 A CN111902129 A CN 111902129A CN 201980017710 A CN201980017710 A CN 201980017710A CN 111902129 A CN111902129 A CN 111902129A
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China
Prior art keywords
gelatin
solution
endotoxin
salt
salt solution
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Pending
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CN201980017710.6A
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English (en)
Chinese (zh)
Inventor
Y·T·黄
K·希尔哈尼
A·鲍威
S·斯图尔特
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Catalent UK Swindon Zydis Ltd
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Catalent UK Swindon Zydis Ltd
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Publication of CN111902129A publication Critical patent/CN111902129A/zh
Pending legal-status Critical Current

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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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09HPREPARATION OF GLUE OR GELATINE
    • C09H3/00Isolation of glue or gelatine from raw materials, e.g. by extracting, by heating
    • C09H3/02Purification of solutions of gelatine
    • 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
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5169Proteins, e.g. albumin, gelatin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J41/00Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/08Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/12Macromolecular compounds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J47/00Ion-exchange processes in general; Apparatus therefor
    • B01J47/014Ion-exchange processes in general; Apparatus therefor in which the adsorbent properties of the ion-exchanger are involved, e.g. recovery of proteins or other high-molecular compounds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J47/00Ion-exchange processes in general; Apparatus therefor
    • B01J47/12Ion-exchange processes in general; Apparatus therefor characterised by the use of ion-exchange material in the form of ribbons, filaments, fibres or sheets, e.g. membranes

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN201980017710.6A 2018-03-08 2019-03-07 减少明胶中内毒素的方法 Pending CN111902129A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862640394P 2018-03-08 2018-03-08
US62/640394 2018-03-08
PCT/IB2019/000234 WO2019171173A1 (en) 2018-03-08 2019-03-07 Process to reduce endotoxin in gelatin

Publications (1)

Publication Number Publication Date
CN111902129A true CN111902129A (zh) 2020-11-06

Family

ID=66668957

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980017710.6A Pending CN111902129A (zh) 2018-03-08 2019-03-07 减少明胶中内毒素的方法

Country Status (11)

Country Link
US (2) US10988638B2 (https=)
EP (1) EP3761956B1 (https=)
JP (1) JP7431741B2 (https=)
CN (1) CN111902129A (https=)
AU (1) AU2019229784A1 (https=)
BR (1) BR112020015253A2 (https=)
CA (1) CA3089172A1 (https=)
ES (1) ES2982045T3 (https=)
IL (1) IL277009B2 (https=)
MX (1) MX2020009112A (https=)
WO (1) WO2019171173A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113607903A (zh) * 2021-07-30 2021-11-05 振德医疗用品股份有限公司 一种检测含有正电荷聚合物细菌内毒素的方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102793584B1 (ko) 2016-12-31 2025-04-09 바이오엑셀 테라퓨틱스 인코포레이티드 불안의 치료를 위한 설하 덱스메데토미딘의 용도
PL3813802T3 (pl) 2018-06-27 2025-04-22 Bioxcel Therapeutics, Inc. Formulacje błony zawierające deksmedetomidynę i sposoby ich wytwarzania
EP3999058A4 (en) 2019-07-19 2023-05-03 Bioxcel Therapeutics, Inc. NON-SEDATIVE DEXMEDETOMIDINE-BASED TREATMENT REGIMEN
HUE056569T2 (hu) 2019-07-31 2022-02-28 Catalent Uk Swindon Zydis Ltd Sûrûség-áramlásmérõ gyógyászati készítmény adagolásához
CN111286276A (zh) * 2020-03-26 2020-06-16 吉林大学 一种林蛙皮明胶的制备方法
WO2022103638A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Cannabinoids in the treatment of autism spectrum disorder
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
EP4501129A4 (en) 2022-03-30 2026-03-11 Toray Industries PROCESS FOR THE PRODUCTION OF GELATIN OR A CONCENTRATED GELATIN SOLUTION
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
NL2038119B1 (en) * 2024-07-02 2026-01-16 Sentryx B V A method for purifying a gelatin

Citations (11)

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US4374063A (en) * 1981-09-28 1983-02-15 General Foods Corporation Process for the preparation and purification of gelatin and pyrogen-free gelatin so prepared
WO1995021179A1 (de) * 1994-02-07 1995-08-10 Qiagen Gmbh Verfahren zur abreicherung oder entfernung von endotoxinen
US20030064074A1 (en) * 1999-11-12 2003-04-03 Chang Robert C. Recombinant gelatins in vaccines
US20030068810A1 (en) * 2000-03-06 2003-04-10 Robertus Hendriks Method for removing endotoxins
JP2007009185A (ja) * 2005-06-02 2007-01-18 Nishikawa Rubber Co Ltd ゼラチンスポンジ
JP2007211170A (ja) * 2006-02-10 2007-08-23 Air Water Inc 低エンドトキシン化ゼラチンの製造方法
US20080132682A1 (en) * 2006-03-03 2008-06-05 Jellice Co., Ltd. Method for manufacturing gelatin with reduced endotoxin content and low endotoxin gelatin
CN101646693A (zh) * 2007-02-28 2010-02-10 利普生技术有限公司 降低多聚唾液酸中的内毒素
CN102099379A (zh) * 2008-06-19 2011-06-15 本德尔分析控股有限公司 用于从生物聚合物材料中去除杂质的方法
CN102423721A (zh) * 2011-08-18 2012-04-25 浙江工业大学 一种磁性阴离子交换剂及其作为内毒素吸附介质的应用
CN104370997A (zh) * 2014-09-24 2015-02-25 陈辉 去除生物制品中细菌内毒素的试剂盒、方法及其生物制品的制备方法

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GB211423A (en) 1923-10-06 1924-02-21 Leopold Seeger Improved means for locking nuts
GB1548022A (en) 1976-10-06 1979-07-04 Wyeth John & Brother Ltd Pharmaceutial dosage forms
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IE53696B1 (en) 1981-12-02 1989-01-18 Wyeth John & Brother Ltd Solid shaped articles
JP3039966B2 (ja) * 1990-07-20 2000-05-08 新田ゼラチン株式会社 ゼラチンのイオン性不純物除去方法
US5616689A (en) * 1994-07-13 1997-04-01 Collagen Corporation Method of controlling structure stability of collagen fibers produced form solutions or dispersions treated with sodium hydroxide for infectious agent deactivation
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JP4099541B2 (ja) 2006-07-19 2008-06-11 ゼライス株式会社 ペプチド精製物の製造方法
US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
US20140142200A1 (en) 2012-11-16 2014-05-22 Eyegenix LLC Keratoprosthesis

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4374063A (en) * 1981-09-28 1983-02-15 General Foods Corporation Process for the preparation and purification of gelatin and pyrogen-free gelatin so prepared
WO1995021179A1 (de) * 1994-02-07 1995-08-10 Qiagen Gmbh Verfahren zur abreicherung oder entfernung von endotoxinen
US20030064074A1 (en) * 1999-11-12 2003-04-03 Chang Robert C. Recombinant gelatins in vaccines
US20030068810A1 (en) * 2000-03-06 2003-04-10 Robertus Hendriks Method for removing endotoxins
JP2007009185A (ja) * 2005-06-02 2007-01-18 Nishikawa Rubber Co Ltd ゼラチンスポンジ
JP2007211170A (ja) * 2006-02-10 2007-08-23 Air Water Inc 低エンドトキシン化ゼラチンの製造方法
US20080132682A1 (en) * 2006-03-03 2008-06-05 Jellice Co., Ltd. Method for manufacturing gelatin with reduced endotoxin content and low endotoxin gelatin
CN101646693A (zh) * 2007-02-28 2010-02-10 利普生技术有限公司 降低多聚唾液酸中的内毒素
CN102099379A (zh) * 2008-06-19 2011-06-15 本德尔分析控股有限公司 用于从生物聚合物材料中去除杂质的方法
CN102423721A (zh) * 2011-08-18 2012-04-25 浙江工业大学 一种磁性阴离子交换剂及其作为内毒素吸附介质的应用
CN104370997A (zh) * 2014-09-24 2015-02-25 陈辉 去除生物制品中细菌内毒素的试剂盒、方法及其生物制品的制备方法

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王欣,等: "食用/工业明胶的凝胶及LF-NMR 弛豫特性的比较", 《分析测试学报》, vol. 37, no. 1, pages 226 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113607903A (zh) * 2021-07-30 2021-11-05 振德医疗用品股份有限公司 一种检测含有正电荷聚合物细菌内毒素的方法
CN113607903B (zh) * 2021-07-30 2024-03-15 振德医疗用品股份有限公司 一种检测含有正电荷聚合物细菌内毒素的方法

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AU2019229784A1 (en) 2020-08-13
WO2019171173A1 (en) 2019-09-12
JP2021516685A (ja) 2021-07-08
IL277009A (en) 2020-10-29
JP7431741B2 (ja) 2024-02-15
ES2982045T3 (es) 2024-10-14
RU2020132925A (ru) 2022-04-08
MX2020009112A (es) 2020-10-01
US20190276707A1 (en) 2019-09-12
US20210207003A1 (en) 2021-07-08
IL277009B1 (en) 2024-02-01
US10988638B2 (en) 2021-04-27
CA3089172A1 (en) 2019-09-12
EP3761956A1 (en) 2021-01-13
IL277009B2 (en) 2024-06-01
EP3761956C0 (en) 2024-06-12
BR112020015253A2 (pt) 2020-12-08
EP3761956B1 (en) 2024-06-12

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Application publication date: 20201106