JP7148499B2 - 嫌気性血液貯蔵および病原体不活性化方法 - Google Patents
嫌気性血液貯蔵および病原体不活性化方法 Download PDFInfo
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- 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
- A61L2/0047—Ultraviolet radiation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
- A61K41/10—Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person
- A61K41/17—Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/18—Erythrocytes
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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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
- A61L2/0076—Radiation using a photocatalyst or photosensitiser
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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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0272—Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/22—Blood or products thereof
Description
本開示は、最大100J/mLの総放射線量を提供し、および包含した。一態様では、放射線量は、10~100J/mLである。別の態様では、放射線量は、50~100J/mLである。別の態様では、放射線量は、50~80J/mLである。他の態様では、放射線量は、150J/mL未満である。一態様では、放射線量は、少なくとも25J/mLである。他の好適な放射線量は、決定されることができる。
実施例3:MIRASOL(登録商標)病原体低減化
実施例4:嫌気性試験製品の貯蔵
実施例5:試料分析
a.試料調製
実施例6:酸素低減化血液についての病原体不活性化方法
実施例7:血液成分のアフェレーシス収集およびUV処理
実施例8:全血のアフェレーシス収集およびUV処理
実施例9:病原体不活性化(S-303)処理RBCの品質の検査
Claims (10)
- 白血球低減化濃厚赤血球(LRpRBC)製剤の血液病原体低減化のための方法であって、
LRpRBC製剤から酸素を除去して、酸素低減化LRpRBC製剤を調製することと、
前記酸素低減化LRpRBC製剤から血液病原体を低減化することと、
アムスタリン(S-303)およびグルタチオン(GSH)を含む前記酸素低減化LRpRBC製剤を、酸素低減化条件下において最長9時間インキュベートして酸素低減化病原体低減化LRpRBC製剤を得、それにより、残存する病原体を60~100%低減し、前記S-303を加水分解してS-300にすること、を含み、
前記血液病原体を低減化することが、
S-303を前記酸素低減化LRpRBC製剤に最終濃度0.1~0.5mMまで添加することと、
GSHを前記酸素低減化LRpRBC製剤に最終濃度2~20mMまで添加することと、
を含む、前記方法。 - 前記酸素低減化病原体低減化LRpRBC製剤を嫌気性条件下で貯蔵することをさらに含む、請求項1に記載の方法。
- 前記酸素低減化LRpRBC製剤から二酸化炭素を低減化することをさらに含む、請求項1に記載の方法。
- 前記S-303の添加後に、前記酸素低減化LRpRBC製剤を遠心分離することをさらに含む、請求項1に記載の方法。
- 前記遠心分離の後に、前記酸素低減化LRpRBC製剤と、酸性pHを有する添加剤溶液とを混合することをさらに含む、請求項4に記載の方法。
- 酸素低減化白血球低減化濃厚赤血球(LRpRBC)製剤におけるアムスタリン(S-303)の病原体不活性化の効力を改善するための方法であって、
LRpRBC製剤から酸素を除去して、酸素低減化LRpRBC製剤を調製することと、
S-303を前記酸素低減化LRpRBC製剤に最終濃度0.1~0.5mMまで添加することと、
グルタチオン(GSH)を前記酸素低減化LRpRBC製剤に最終濃度2~20mMまで添加することと、
前記S-303およびGSHを含む前記酸素低減化LRpRBC製剤を、酸素低減化条件下において、最長9時間インキュベートして酸素低減化病原体低減化LRpRBC製剤を得、それにより、残存する病原体を60~100%低減し、前記S-303を加水分解してS-300にすること、を含む、前記方法。 - 前記酸素低減化LRpRBC製剤から二酸化炭素を低減化することをさらに含む、請求項6に記載の方法。
- さらに、前記酸素低減化病原体低減化LRpRBC製剤を嫌気性条件下で保存することを含む、請求項6に記載の方法。
- 酸素の除去が、前記血液病原体の低減化と同時に起こる、請求項1に記載の方法。
- 酸素の除去が、アムスタリン(S-303)の添加と同時に起こる、請求項6に記載の方法。
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