CN1272061A - 通用血浆 - Google Patents
通用血浆 Download PDFInfo
- Publication number
- CN1272061A CN1272061A CN98809602A CN98809602A CN1272061A CN 1272061 A CN1272061 A CN 1272061A CN 98809602 A CN98809602 A CN 98809602A CN 98809602 A CN98809602 A CN 98809602A CN 1272061 A CN1272061 A CN 1272061A
- Authority
- CN
- China
- Prior art keywords
- blood
- plasma
- blood plasma
- type
- donor
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Cell Biology (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Biotechnology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Virology (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- External Artificial Organs (AREA)
- Prostheses (AREA)
Abstract
一种通用血浆,该血浆可通过如下方法获得,其步骤包括:将A型和B型,任选地AB型的血或血浆混合,但基本上不混合来源于O型血的血液或血浆。
Description
本发明涉及通用血浆以及其制备方法。
血浆是一种广泛应用于失血的代用品,例如手术期间或事故后出现严重失血时。有四种主要的血型,目前对不同血型的重病人配制不同的血浆。很显然,由于四种不同的血浆制品必须分开贮放于血库或医院的血液中心,因而对使用带来不便。另外,测定需要血液替代品的病人的血型是必要的。这种迟延在急诊病例中可能是危急的。
因此,本发明一个目的是提供能通用于不同血型病人的血浆制品。
本发明提供通用血浆,它通过将来源于A型和B型的血或血浆以及任选地来自AB型的血或血浆混合而得到,但基本上不混合来源于O型血的血或血浆。
本发明的血浆制品是先进的,因为没有输入不相容血浆的危险,所述危险可引起严重的甚至致命的不利反应。此外,本发明的血浆制品可以放在打算使用的位置,如手术室和急诊室。这样,最终使用者能够在需要时立即得到这种挽救生命的产品,各个最终使用者不必等候从血液中心定购的产品的发送。目前,血液中心不得不按照接受者的血型发送特异血型的血浆。
在本发明优选的实施方案中,血浆的ABO血型特异性抗体被中和和/或除去。
基本不含O型血成分的血浆制品使血浆制品更通用。本发明的血浆制品优选地包含大量采自A型血供血者的血浆、中等量采自B型血供血者中的血浆和任选地小量采自AB型血供血者的血浆。本发明血浆基本不含采自O型血供血者的血浆。本发明更优选的实施方案是,血浆含有6~10份采自A型血供血者的血浆、1~3份采自B型血供血者的血浆和0.0~1.5份采自AB型血供血者的血浆,并且基本上不含O型血的血浆。
在本发明非常优选的实施方案中,血浆包含7.5~8.5份采自A型血供血者的血浆,1.5~2.5份采自B型血供血者的血浆,和任选地1份采自AB型血供血者的血浆,并且基本上没有采自O型血的血或血浆。
优选地,本发明血浆是通过将采自任何供血者中的血浆汇合而制备。汇合的血浆优选已将病毒灭活。在不同的A、B、AB型血或血浆混合之前或者在本发明血浆制备之后完成病毒灭活。可以使用本领域任何灭活病毒的方法,如通过光化性射线照射、巴氏消毒法、溶媒去污(solvent detergent)处理或这些方法的组合而使病毒灭活。例如,本领域一个众所周知的方法是按照EP-A-0 131 740公开的溶媒洗涤剂处理,以及根据瑞士Octapharma AG在WO-A-94/17834中开发的方法。
本发明血浆可以按本领域技术人员已知的任何状态贮藏和递送。血浆可含有可药用辅剂,如稳定剂和抗凝剂。
优选地,本发明血浆以固体状态如冷冻形式贮藏或递送。此外,以冻干或喷雾干燥形式贮藏或递送此发明的血浆也许是有利的。万一需要干燥血浆,它能很容易地溶解在无菌水中以便输给病人。
本发明血浆的ABO血型特异性抗体的效价更优选地是:抗A/抗BIgM低于16,抗A/抗B IgG低于64。在非常优选的实施方案中,抗A和抗B抗体的效价:IgM低于8,IgG低于32。
此发明血浆的制备方法包括合并含有A、B和任选的AB血型供血者的血或血浆以及中和和/或除去抗体的步骤。
如果血液作为起始物料,则使用本领域已知技术由血池制备血浆。
全部供血者中超过2/3的人在血浆中有游离A和/或B物质,这些物质几乎与同红细胞表面结合的A和B抗原相同。通过混和适量的A型、B型和任选的AB型血的血和血浆,IgM和IgG亚型的抗A和抗B抗体通过与两种游离A和/或B物质结合而被中和,和/或在进一步加工过程中被去除。
令人惊奇的是,尽管本发明血浆作为既含有残留红细胞又含有全部补体系统的粗材料使用,但在生产过程中或在最后的产品中没有补体活性的迹象。根据该制备方法,优选的是:在该方法开始时将血浆单位合并以及去除全部的细胞和病毒灭活过程(优选溶媒去污处理)期间完成血浆混合。终产品的输入速度和总剂量可以不受限制地使用。
由于还有凝固活性,本发明方法制备的血浆是有利的。
本发明将被进一步阐明但并不限于下面的实施例。
实施例
新鲜-冷冻血浆采自A型血278升,B型血68升,AB型血34升,将它们混合在一起,解冻。二水磷酸二氢钠作为缓冲液加入以稳定血浆蛋白。用1μm孔滤膜过滤后,溶媒去污法灭活病毒。去除病毒灭活剂之后,加入甘氨酸以调节渗透压。在质量控制期间检测游离抗A和抗B抗体量。这种检测是本领域所熟知的。抗A和抗B抗体的效价应当是:IgM<8,IgG<32。
Claims (10)
1.通用血浆,该血浆可由如下方法获得,其中包括步骤:将A型血和B型血,任选地AB型血的血或血浆混合,但基本上不混合来源于0型血的血液或血浆。
2.权利要求1所述的血浆,其中血浆的ABO血型特异性抗体被中和和/或除去。
3.权利要求2所述的血浆,包含大量采自A型血供血者的血浆、中等量采自B型血供血者的血浆,和任选的小量采自AB型血供血者的血浆。
4.权利要求3所述的血浆,包含
-6~10份采自A型血供血者的血液或血浆,
-1~3份采自B型血供血者的血液或血浆,
-0.0~1.5份采自AB型血供血者的血液或血浆,
-基本上没有采自O型血供血者的血液或血浆。
5.前述任一项权利要求所述的血浆,呈液态、冷冻或干燥状态。
6.权利要求5所述血浆,呈冻干或喷雾干燥形式。
7.前述任一项权利要求所述的血液或血浆,含有可药用辅剂如稳定剂和抗凝剂。
8.前述任一项权利要求所述的血液或血浆,所述血浆经过病毒灭活处理。
9.制备权利要求1所述的血液或血浆的方法,包括以下步骤:
-合并A型血和B型血供血者的血液或血浆,
-任选地混合AB型血供血者的血液或血浆,
-任选地从血液或血浆池中生产血浆,
-中和和/或除去ABO血型特异性抗体。
10.权利要求9所述的方法,进一步包含喷雾干燥或冻干血浆的步骤。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP97113466A EP0896824A1 (en) | 1997-08-05 | 1997-08-05 | A universally applicable blood plasma |
EP97113466.3 | 1997-08-05 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN1272061A true CN1272061A (zh) | 2000-11-01 |
Family
ID=8227172
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN98809602A Pending CN1272061A (zh) | 1997-08-05 | 1998-08-04 | 通用血浆 |
Country Status (25)
Country | Link |
---|---|
US (1) | US20110008459A1 (zh) |
EP (2) | EP0896824A1 (zh) |
JP (1) | JP2001513507A (zh) |
CN (1) | CN1272061A (zh) |
AT (1) | ATE225665T1 (zh) |
AU (1) | AU742427B2 (zh) |
BG (1) | BG64350B1 (zh) |
BR (1) | BR9811839A (zh) |
CA (1) | CA2299421C (zh) |
CZ (1) | CZ293726B6 (zh) |
DE (1) | DE69808620T3 (zh) |
DK (1) | DK0991416T4 (zh) |
EA (1) | EA003182B1 (zh) |
ES (1) | ES2185218T5 (zh) |
HK (1) | HK1026146A1 (zh) |
HU (1) | HU226548B1 (zh) |
ID (1) | ID24308A (zh) |
IL (1) | IL134308A (zh) |
NO (1) | NO326216B1 (zh) |
NZ (1) | NZ502661A (zh) |
PL (1) | PL193983B1 (zh) |
PT (1) | PT991416E (zh) |
RS (1) | RS50016B (zh) |
TW (1) | TW555563B (zh) |
WO (1) | WO1999007390A1 (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2002083157A1 (fr) * | 2001-04-18 | 2002-10-24 | Jianchuan Ma | Plasma sanguin humain exempt de groupe sanguin et son procede de preparation |
CN102448475A (zh) * | 2009-04-09 | 2012-05-09 | 恩特格利昂公司 | 喷雾干燥的血液产品和制造其的方法 |
CN1893960B (zh) * | 2003-12-19 | 2012-10-31 | 奥克塔法马股份有限公司 | 从非高加索人血浆生产的普遍适用的病毒灭活血浆 |
Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6214221B1 (en) * | 1999-02-22 | 2001-04-10 | Henry B. Kopf | Method and apparatus for purification of biological substances |
EP1958618A1 (de) | 2007-02-15 | 2008-08-20 | Octapharma AG | Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren |
US8407912B2 (en) | 2010-09-16 | 2013-04-02 | Velico Medical, Inc. | Spray dried human plasma |
US20110142885A1 (en) | 2009-09-16 | 2011-06-16 | Velico Medical, Inc. | Spray-dried human plasma |
FR2963737B1 (fr) * | 2010-08-16 | 2013-04-05 | Etat Francais Ministere De La Defense Service De Sante Des Armees | Procede de lyophilisation de plasma sanguin |
US20140083628A1 (en) | 2012-09-27 | 2014-03-27 | Velico Medical, Inc. | Spray drier assembly for automated spray drying |
AU2011320528A1 (en) | 2010-10-29 | 2013-05-23 | Velico Medical, Inc. | System and method for spray drying a liquid |
US9561184B2 (en) | 2014-09-19 | 2017-02-07 | Velico Medical, Inc. | Methods and systems for multi-stage drying of plasma |
FR3026950A1 (fr) | 2014-10-09 | 2016-04-15 | Lab Francais Du Fractionnement | Procede de preparation de plasma universel |
FR3035799B1 (fr) | 2015-05-06 | 2017-05-05 | Elicityl | Support pour la purification de liquides biologiques |
FR3035794B1 (fr) | 2015-05-06 | 2017-05-05 | Elicityl | Procede pour la purification du sang total ou d'un produit issu du sang |
WO2019074886A1 (en) | 2017-10-09 | 2019-04-18 | Terumo Bct Biotechnologies, Llc | LYOPHILIZATION CONTAINER AND METHOD OF USE |
FR3083121B1 (fr) | 2018-06-27 | 2021-10-22 | Maco Pharma Sa | Procede de greffage d un element fibreux pour l elimination d anticorps du sang ou d un composant sanguin |
EP3937878A2 (en) | 2019-03-14 | 2022-01-19 | Terumo BCT Biotechnologies, LLC | Lyophilization loading tray assembly and system |
DE102020212609B3 (de) * | 2020-10-06 | 2022-04-07 | Universität Greifswald | Verfahren und Vorrichtung zur Herstellung von Universalplasma |
US12083447B2 (en) | 2022-09-15 | 2024-09-10 | Velico Medical, Inc. | Alignment of a disposable for a spray drying plasma system |
US11841189B1 (en) | 2022-09-15 | 2023-12-12 | Velico Medical, Inc. | Disposable for a spray drying system |
US11998861B2 (en) | 2022-09-15 | 2024-06-04 | Velico Medical, Inc. | Usability of a disposable for a spray drying plasma system |
US11975274B2 (en) | 2022-09-15 | 2024-05-07 | Velico Medical, Inc. | Blood plasma product |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4664913A (en) * | 1982-05-24 | 1987-05-12 | Xoma Corporation | Method for treating plasma for transfusion |
US4764369A (en) * | 1983-07-14 | 1988-08-16 | New York Blood Center Inc. | Undenatured virus-free biologically active protein derivatives |
US4551435A (en) * | 1983-08-24 | 1985-11-05 | Immunicon, Inc. | Selective removal of immunospecifically recognizable substances from solution |
JPH0723319B2 (ja) * | 1986-05-14 | 1995-03-15 | 株式会社ミドリ十字 | 血液製剤から血液型抗体を除去する方法 |
DE4008852A1 (de) † | 1990-03-20 | 1991-09-26 | Octapharma Ag | Verfahren zur herstellung von nicht-infektioesem blutplasma |
US5217627A (en) * | 1990-11-06 | 1993-06-08 | Pall Corporation | System and method for processing biological fluid |
JP3575770B2 (ja) * | 1992-03-31 | 2004-10-13 | 学校法人藤田学園 | 血漿由来製剤 |
AU667530B2 (en) * | 1992-05-28 | 1996-03-28 | New York Blood Center, Inc., The | Removal of antibodies from blood-derived compositions while retaining coagulation factors |
-
1997
- 1997-08-05 EP EP97113466A patent/EP0896824A1/en not_active Withdrawn
-
1998
- 1998-02-19 TW TW087102313A patent/TW555563B/zh not_active IP Right Cessation
- 1998-08-04 DK DK98945141T patent/DK0991416T4/da active
- 1998-08-04 NZ NZ502661A patent/NZ502661A/xx not_active IP Right Cessation
- 1998-08-04 IL IL13430898A patent/IL134308A/en not_active IP Right Cessation
- 1998-08-04 AT AT98945141T patent/ATE225665T1/de active
- 1998-08-04 CN CN98809602A patent/CN1272061A/zh active Pending
- 1998-08-04 ES ES98945141T patent/ES2185218T5/es not_active Expired - Lifetime
- 1998-08-04 WO PCT/EP1998/004841 patent/WO1999007390A1/en active IP Right Grant
- 1998-08-04 JP JP2000506980A patent/JP2001513507A/ja active Pending
- 1998-08-04 CZ CZ2000370A patent/CZ293726B6/cs not_active IP Right Cessation
- 1998-08-04 HU HU0004795A patent/HU226548B1/hu not_active IP Right Cessation
- 1998-08-04 ID IDW20000224A patent/ID24308A/id unknown
- 1998-08-04 EA EA200000196A patent/EA003182B1/ru not_active IP Right Cessation
- 1998-08-04 PL PL98338794A patent/PL193983B1/pl not_active IP Right Cessation
- 1998-08-04 DE DE69808620T patent/DE69808620T3/de not_active Expired - Lifetime
- 1998-08-04 CA CA002299421A patent/CA2299421C/en not_active Expired - Fee Related
- 1998-08-04 EP EP98945141A patent/EP0991416B2/en not_active Expired - Lifetime
- 1998-08-04 BR BR9811839-0A patent/BR9811839A/pt not_active Application Discontinuation
- 1998-08-04 PT PT98945141T patent/PT991416E/pt unknown
- 1998-08-04 RS YUP-58/00A patent/RS50016B/sr unknown
- 1998-08-04 AU AU92569/98A patent/AU742427B2/en not_active Ceased
-
2000
- 2000-02-01 BG BG104117A patent/BG64350B1/bg unknown
- 2000-02-04 NO NO20000578A patent/NO326216B1/no not_active IP Right Cessation
- 2000-08-31 HK HK00105463A patent/HK1026146A1/xx not_active IP Right Cessation
-
2010
- 2010-09-17 US US12/923,380 patent/US20110008459A1/en not_active Abandoned
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2002083157A1 (fr) * | 2001-04-18 | 2002-10-24 | Jianchuan Ma | Plasma sanguin humain exempt de groupe sanguin et son procede de preparation |
CN1893960B (zh) * | 2003-12-19 | 2012-10-31 | 奥克塔法马股份有限公司 | 从非高加索人血浆生产的普遍适用的病毒灭活血浆 |
CN102448475A (zh) * | 2009-04-09 | 2012-05-09 | 恩特格利昂公司 | 喷雾干燥的血液产品和制造其的方法 |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN1272061A (zh) | 通用血浆 | |
US6274090B1 (en) | Apparatus and method of preparation of stable, long term thrombin from plasma and thrombin formed thereby | |
US20090092678A1 (en) | Universally applicable blood plasma | |
EP0479597B1 (en) | Process for producing secretory immunoglobulin-A preparations | |
KR101209162B1 (ko) | 바이러스에 안전한 생물학적 유체의 개선 방법 | |
CN1321468A (zh) | 无血型冻干血浆及其制备方法 | |
US20110104298A1 (en) | Universally applicable virus inactivated blood plasma produced from portions of non-Caucasians plasma | |
Branson et al. | A structured approach to the management of purpura fulminans | |
US20210322480A1 (en) | Platelet-Rich Plasma Compositions and Related Methods | |
MXPA00001259A (en) | A universally applicable blood plasma | |
CA2523357A1 (en) | Treatment of hi-virus infections with oxidised blood proteins |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C12 | Rejection of a patent application after its publication | ||
RJ01 | Rejection of invention patent application after publication |