CN112135641A - 在辐射灭菌过程中保护生物活性分子 - Google Patents

在辐射灭菌过程中保护生物活性分子 Download PDF

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Publication number
CN112135641A
CN112135641A CN201980033117.0A CN201980033117A CN112135641A CN 112135641 A CN112135641 A CN 112135641A CN 201980033117 A CN201980033117 A CN 201980033117A CN 112135641 A CN112135641 A CN 112135641A
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CN
China
Prior art keywords
radiation
mixture
radioprotective
biologically active
biological activity
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Pending
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CN201980033117.0A
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English (en)
Chinese (zh)
Inventor
P·Q·胡
N·P·艾伦
J·L·霍华德
J·鲍伊尔
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Intelligent Bio Systems Inc
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Intelligent Bio Systems Inc
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Application filed by Intelligent Bio Systems Inc filed Critical Intelligent Bio Systems Inc
Publication of CN112135641A publication Critical patent/CN112135641A/zh
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54393—Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Peptides Or Proteins (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
CN201980033117.0A 2018-05-18 2019-05-17 在辐射灭菌过程中保护生物活性分子 Pending CN112135641A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862673671P 2018-05-18 2018-05-18
US62/673,671 2018-05-18
PCT/US2019/032885 WO2019222638A1 (en) 2018-05-18 2019-05-17 Protection of biologically active molecules during radiation sterilization

Publications (1)

Publication Number Publication Date
CN112135641A true CN112135641A (zh) 2020-12-25

Family

ID=66770587

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980033117.0A Pending CN112135641A (zh) 2018-05-18 2019-05-17 在辐射灭菌过程中保护生物活性分子

Country Status (9)

Country Link
US (1) US20210260225A1 (enExample)
EP (1) EP3793621A1 (enExample)
JP (2) JP7487184B2 (enExample)
KR (2) KR102774917B1 (enExample)
CN (1) CN112135641A (enExample)
AU (2) AU2019269671B2 (enExample)
MX (1) MX2020012237A (enExample)
SG (1) SG11202009795PA (enExample)
WO (1) WO2019222638A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114621467A (zh) * 2022-05-17 2022-06-14 天新福（北京）医疗器材股份有限公司 一种无菌自固化胶原蛋白修复凝胶及其制备方法
CN115611978A (zh) * 2022-11-21 2023-01-17 成都奇璞生物科技有限公司 一种辐照保护剂在制备胶原蛋白产品中的用途

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5730933A (en) * 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
US20030012687A1 (en) * 2000-03-23 2003-01-16 Macphee Martin J. Methods of sterilizing biological materials
CN1427729A (zh) * 2000-03-23 2003-07-02 科利昂特有限公司 生物材料消毒方法
US20030161753A1 (en) * 2001-03-23 2003-08-28 Macphee Martin Methods for sterilizing biological materials by multiple rates
EP1415669A1 (en) * 2002-09-19 2004-05-06 Aventis Behring GmbH Process for sterilization of protein containing biological compositions
CN1606457A (zh) * 2001-08-31 2005-04-13 克里兰特公司 将含有白蛋白的制剂灭菌的方法
WO2008081166A1 (en) * 2006-12-29 2008-07-10 Arecor Limited Protein sterilisation by radiation and addition of a stabilising composition
WO2016196662A1 (en) * 2015-06-02 2016-12-08 Medtronic Minimed, Inc. Protective agents against e-beam irradiation for proteins in optical sensing chemistry

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2649224B2 (ja) * 1987-02-25 1997-09-03 旭メディカル 株式会社 体液処理装置の滅菌方法および滅菌された体液処理装置
US6551794B1 (en) * 1995-11-09 2003-04-22 E. R. Squibb & Sons, Inc. Stable biotinylated biomolecule composition
JP4071283B2 (ja) * 1996-02-05 2008-04-02 旭化成クラレメディカル株式会社 滅菌保護剤及び滅菌方法
US20040086420A1 (en) 2000-03-23 2004-05-06 Macphee Martin J. Methods for sterilizing serum or plasma
US6696060B2 (en) * 2001-06-14 2004-02-24 Clearant, Inc. Methods for sterilizing preparations of monoclonal immunoglobulins
US6946098B2 (en) 2001-08-10 2005-09-20 Clearant, Inc. Methods for sterilizing biological materials
US20030031584A1 (en) 2001-08-10 2003-02-13 Wilson Burgess Methods for sterilizing biological materials using dipeptide stabilizers
US6749851B2 (en) * 2001-08-31 2004-06-15 Clearant, Inc. Methods for sterilizing preparations of digestive enzymes
US20050069453A1 (en) 2003-09-29 2005-03-31 Ren-Yo Forng Methods for sterilizing preparations of urokinase
US20050175630A1 (en) * 2003-12-23 2005-08-11 Eyal Raz Immunogenic compositions and methods of use thereof
US8304439B1 (en) * 2007-10-12 2012-11-06 Politechnika Lodzka Use of quaternary pyridinium salts as a therapeutic or preventing agent against ionizing radiation-induced damage
EP2236520A1 (en) * 2009-03-31 2010-10-06 Leukocare Ag Stabilizing composition for immobilized biomolecules
EP2236617A1 (en) * 2009-03-31 2010-10-06 Leukocare Ag Methods of terminal sterilization of biofunctional compositions
US8999720B2 (en) * 2011-11-17 2015-04-07 Medtronic Minimed, Inc. Aqueous radiation protecting formulations and methods for making and using them
CN108064229B (zh) * 2015-03-12 2021-12-28 三洋化成工业株式会社 蛋白质组合物的制造方法和蛋白质组合物
WO2016146573A1 (en) * 2015-03-13 2016-09-22 Repoceuticals Aps Melatonin for preventing and treating radiation cystitis
CN109640981A (zh) * 2016-06-29 2019-04-16 曼隆治疗公司 神经激肽-1拮抗剂用于治疗多种瘙痒病症的用途
WO2019166003A1 (zh) * 2018-03-02 2019-09-06 郑州大学 14-脱氧-11,12-脱氢-8,12-环氧或7,8-烯-穿心莲内酯及其15位取代衍生物和用途

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5730933A (en) * 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
US20030012687A1 (en) * 2000-03-23 2003-01-16 Macphee Martin J. Methods of sterilizing biological materials
CN1427729A (zh) * 2000-03-23 2003-07-02 科利昂特有限公司 生物材料消毒方法
US20030161753A1 (en) * 2001-03-23 2003-08-28 Macphee Martin Methods for sterilizing biological materials by multiple rates
CN1606457A (zh) * 2001-08-31 2005-04-13 克里兰特公司 将含有白蛋白的制剂灭菌的方法
EP1415669A1 (en) * 2002-09-19 2004-05-06 Aventis Behring GmbH Process for sterilization of protein containing biological compositions
WO2008081166A1 (en) * 2006-12-29 2008-07-10 Arecor Limited Protein sterilisation by radiation and addition of a stabilising composition
WO2016196662A1 (en) * 2015-06-02 2016-12-08 Medtronic Minimed, Inc. Protective agents against e-beam irradiation for proteins in optical sensing chemistry

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ZBIKOWSKA等: "The role of ascorbate and histidine in fibrinogen protection against changes following exposure to a sterilizing dose of γ-irradiation", 《BLOOD COAGULATION & FIBRINOLYSIS》 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114621467A (zh) * 2022-05-17 2022-06-14 天新福（北京）医疗器材股份有限公司 一种无菌自固化胶原蛋白修复凝胶及其制备方法
CN114621467B (zh) * 2022-05-17 2022-07-29 天新福（北京）医疗器材股份有限公司 一种无菌自固化胶原蛋白修复凝胶及其制备方法
CN115611978A (zh) * 2022-11-21 2023-01-17 成都奇璞生物科技有限公司 一种辐照保护剂在制备胶原蛋白产品中的用途
CN115611978B (zh) * 2022-11-21 2023-03-07 成都奇璞生物科技有限公司 一种辐照保护剂在制备胶原蛋白产品中的用途

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Publication number Publication date
US20210260225A1 (en) 2021-08-26
CA3096717A1 (en) 2019-11-21
SG11202009795PA (en) 2020-12-30
KR20250030028A (ko) 2025-03-05
KR20210013553A (ko) 2021-02-04
JP2024073470A (ja) 2024-05-29
KR102774917B1 (ko) 2025-03-04
MX2020012237A (es) 2021-03-25
EP3793621A1 (en) 2021-03-24
BR112020021358A2 (pt) 2021-01-19
WO2019222638A1 (en) 2019-11-21
AU2019269671A1 (en) 2020-10-22
JP7487184B2 (ja) 2024-05-20
AU2019269671B2 (en) 2025-01-30
JP2021524362A (ja) 2021-09-13
AU2025202786A1 (en) 2025-05-08

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