CN1207004C - 通用型冻干血浆及其制备方法 - Google Patents
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Abstract
本发明涉及一种适于临床各种血型病人输用的无血型冻干血浆及其制备方法，它由A、B、O和AB型四种血型血浆按下述容量配比混合，并经病毒灭活后，加入适量保护剂经旋冻、冻干制备而成：A型血浆5-10份，B型血浆2-7份，O型血浆0.5-3份，AB型血浆0.5-3份。本发明不仅原料来源广泛，使用方便简捷，而且各种凝血因子的回收率高，具有通用、安全和有效的特性。
Description
本发明涉及一种适于临床各种血型病人输用以补充其人体血液的通用型冻干血浆及其制备方法，属于一种血浆制品。
近十多年来，随着输血生理病理研究的深入和临床经验的积累，血浆作为一种人体血液的补充剂在临床上的应用日益增多。由于在人体ABO血型系统中存在的A、B、O和AB四种血型，目前，针对四种不同血型的病人，血浆的输用，一是需要配制四种不同血型的血浆，配制的血浆制品必须分开贮存；二是对输用者必须进行血型测定，这不仅给血浆的使用带来很多不便，而且有时候还会延误对急诊病人的抢救。为解决上述存在的问题，在中国专利公报CN1272061A中公开了一种通用血浆，该血浆能不分血型通用于各种血型的病人，给血浆的使用带来了很大的方便。然而，该通用血浆的制作主要采用A型和B型血浆混合，很少采用或不用AB型血浆，O型血浆完全不用，这就使得血浆制作的原料来源受到很大的制约；其次，该血浆尚未进行抗A、抗B凝集效价的检测，因此，离实际的临床使用尚存在一些差距。此外，该血浆也未提及凝血因子的收获率，而凝血因子是影响输用者凝血功能的一个重要因素。
本发明的目的是针对上述现有技术存在的不足而提供一种通用型冻干血浆，它不仅使用方便，而且原料来源广泛，完全具备临床使用的实用性，安全性和有效性。
本发明的另一个目的是要提供一种通用型冻干血浆的制备方法。
本发明的目的由以下的技术方案来实现：主要由A、B、O和AB四种血型血浆按下述容量配比混合，经病毒灭活后，加入适量保护剂，并经旋冻、冻干制备而成：
A型血浆 5-10份 B型血浆 2-7份
O型血浆 0.5-3份 AB型血浆 0.5-3份。
按上述方案，本发明四种血型血浆混合的优选配比为：
A型血浆 5-7份 B型血浆 3-6份
O型血浆 0.5-2份 AB型血浆 0.5-2份。
本发明血浆的剂型为冻干血浆制剂，成干粉末状。
本发明血浆的凝集素效价为：抗A≤1∶4-1∶8，抗B≤1∶8-1∶16。
本发明所述的病毒灭活方法为：采用有机溶剂/去污剂即S/D灭活法，具体步骤是：用1％的TNBP加1％的TntonX-100在30℃处理血浆4小时，然后用植物油(大豆油)萃取有机溶剂TNBP，用Prepc18固相层析法去除无离子去污剂TritonX-100，使S/D的残留量低于规定标准。采用S/D灭活法能有效灭活血浆中的脂包膜病毒，输注人体后不良反应少，无传播乙型肝炎、丙型肝炎和艾滋病的危险。
本发明所述的保护剂为：氯化钙、蔗糖、甘露醇、葡萄糖和谷光甘肽，其中的任意一种或多种。
本发明的制备过程为：将采集的合格血浆速置-30℃冰冻保存，按容量配比将四种血型血浆溶浆混合，加入适量保护剂，用S/D法进行病毒灭活处理，超滤浓缩，再加入保护剂，调整PH值7.4±1.0，除菌分装，最后在≤-30℃的温度下进行旋冻，再在≤35℃的温度下和≤50小时时间内冻干处理，成为冻干血浆制剂。
本发明的积极效果和特性在于：1、本发明采用四种血型血浆混合而成，其原料来源更为丰富广泛；2、通过四种血型血浆适当比例的混合，使血浆中存在的抗A、抗B抗体(凝集素)被中和、稀释，并在制备过程中减少或去除，经对本发明多个实施例的检测，其抗A凝集效价和抗B凝集效价均在1∶8以下，完全符合1∶16的人体输血标准，可以为临床各种血型的病人所输用，使用方便简捷；3、进行S/D法病毒灭活，不仅方法简便，而且能有效灭活和消除血浆中的HBV、HCV和HIV等经血传播的病毒，保证了临床使用的安全性；4、在制备过程中原料血浆速置-30℃冰冻保存，并加入适量的保护剂，同时采用低温旋冻和限时冻干等处理方式，因而，能稳定血浆中各种活性凝血因子免受理化因素的影响，保证制剂中除有各种蛋白成分外，纤维蛋白原、V因子、VIII因子、IX因子、X因子等主要凝血因子的回收率均在65％以上，保证了血浆制品的有效性；5、本发明的冻干血浆具有保存时间长，便于运输，适于战备，使用方便的特点。
本发明的优选实施例如下表所示：
| 组别 | 各型血浆混合比例(％) | 凝集效价滴度 | 备注 | ||||
| A型 | B型 | O型 | AB型 | 抗A | 抗B | ||
| 1# | 50 | 20 | 20 | 10 | 1∶2 | 1∶8 | |
| 2# | 50 | 30 | 10 | 10 | 1∶2 | 1∶4 | |
| 3# | 60 | 30 | 5 | 5 | 1∶2 | 1∶4 | |
| 4# | 50 | 35 | 5 | 10 | 1∶2 | 1∶4 | |
按混合后的血浆的凝集效价，不得大于1∶16为标准，以上各组混合血浆均符合无血型血浆的要求。
上述各实施例的血浆剂型为冻干血浆制剂。
Claims (10)
1、一种通用型冻干血浆，其特征在于它是通过下述方法制成的：将采集的合格血浆速置-30℃冰冻保存，按下述容量配比将A、B、O、AB四种血型血浆混合，并经病毒灭活后，加入适量保护剂，除菌分装，再在≤-30℃的温度下进行旋冻，然后在≤35℃的温度下和≤50小时内冻干处理，得到冻干血浆制剂，
A型血浆：5-10份 B型血浆：2-7份
O型血浆：0.5-3份 AB型血浆：0.5-3份
其中所述的保护剂为选自氯化钙、蔗糖、甘露醇、葡萄糖和谷光甘肽中的任意一种或多种。
2、按权利要求1所述的通用型冻干血浆，其特征在于：四种血型血浆混合的容量配比分别为：
A型血浆：5-7份 B型血浆：3-6份
O型血浆：0.5-2份 AB型血浆：0.5-2份。
3、按权利要求1所述的通用型冻干血浆，其特征在于四种血型血浆混合的容量配比分别为：A型血浆5份，B型血浆2份，O型血浆2份，AB型血浆1份。
4、按权利要求1所述的通用型冻干血浆，其特征在于四种血型血浆混合的容量配比分别为：A型血浆5份，B型血浆3份，O型血浆1份，AB型血浆1份。
5、按权利要求1所述的通用型冻干血浆，其特征在于四种血型血浆混合的容量配比分别为：A型血浆5份，B型血浆3.5份，O型血浆0.5份，AB型血浆1份。
6、按权利要求1所述的通用型冻干血浆，其特征在于四种血型血浆混合的容量配比分别为：A型血浆6份，B型血浆3份，O型血浆0.5份，AB型血浆0.5份。
7、按权利要求1所述的通用型冻干血浆，其特征在于：所述的病毒灭活方法为S/D灭活法。
8、按权利要求1-7任一所述的通用型冻干血浆，其特征在于：所得到的血浆的凝集素效价为抗A≤1∶8，抗B≤1∶16。
9、按权利要求1-8任一所述的通用型冻干血浆，其特征在于所述的血浆中纤维蛋白原、凝血因子V、VIII、IX、X的回收率均达65％以上。
10、权利要求1-6任一所述的通用型冻干血浆的制备方法，其特征在于包括下述步骤：将采集的合格血浆速置-30℃冰冻保存，按所述容量配比将A、B、O、AB四种血型血浆混合，并经病毒灭活后，加入保护剂，除菌分装，再在≤-30℃的温度下进行旋冻，然后在≤35℃的温度下和≤50小时内冻干处理，即可。
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011066377A CN1207004C (zh) | 2001-04-18 | 2001-04-18 | 通用型冻干血浆及其制备方法 |
| PCT/CN2002/000264 WO2002083157A1 (fr) | 2001-04-18 | 2002-04-17 | Plasma sanguin humain exempt de groupe sanguin et son procede de preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011066377A CN1207004C (zh) | 2001-04-18 | 2001-04-18 | 通用型冻干血浆及其制备方法 |
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| Publication Number | Publication Date |
|---|---|
| CN1321468A CN1321468A (zh) | 2001-11-14 |
| CN1207004C true CN1207004C (zh) | 2005-06-22 |
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| CNB011066377A Expired - Lifetime CN1207004C (zh) | 2001-04-18 | 2001-04-18 | 通用型冻干血浆及其制备方法 |
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| Country | Link |
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| CN (1) | CN1207004C (zh) |
| WO (1) | WO2002083157A1 (zh) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| DK1696940T3 (da) * | 2003-12-19 | 2007-07-30 | Octapharma Ag | Universelt anvendeligt virus-inaktiveret blodplasma fremstillet fra portioner af ikke-kaukasisk plasma |
| CN100431550C (zh) * | 2005-01-12 | 2008-11-12 | 马建川 | 通用型新鲜冰冻血浆 |
| 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 |
| US9561184B2 (en) | 2014-09-19 | 2017-02-07 | Velico Medical, Inc. | Methods and systems for multi-stage drying of plasma |
| CN105832768A (zh) * | 2015-08-11 | 2016-08-10 | 杜祖英 | 具有多种功能的人血浆及其制备方法 |
| WO2019074886A1 (en) | 2017-10-09 | 2019-04-18 | Terumo Bct Biotechnologies, Llc | LYOPHILIZATION CONTAINER AND METHOD OF USE |
| US11609043B2 (en) | 2019-03-14 | 2023-03-21 | Terumo Bct Biotechnologies, Llc | Lyophilization container fill fixture, system and method of use |
| CN114617903B (zh) * | 2022-03-15 | 2024-05-24 | 中国人民解放军总医院第一医学中心 | 一种用于血浆冻干的组合物及其应用 |
| US11841189B1 (en) | 2022-09-15 | 2023-12-12 | Velico Medical, Inc. | Disposable for a spray drying system |
| US11975274B2 (en) | 2022-09-15 | 2024-05-07 | Velico Medical, Inc. | Blood plasma product |
| US11998861B2 (en) | 2022-09-15 | 2024-06-04 | Velico Medical, Inc. | Usability of a disposable for a spray drying plasma system |
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| US4664913A (en) * | 1982-05-24 | 1987-05-12 | Xoma Corporation | Method for treating plasma for transfusion |
| CN1042474A (zh) * | 1988-11-10 | 1990-05-30 | 济南军区药物研究中心 | 果胶代血浆及制备方法 |
| EP0896824A1 (en) * | 1997-08-05 | 1999-02-17 | Octapharma Ag | A universally applicable blood plasma |
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- 2001-04-18 CN CNB011066377A patent/CN1207004C/zh not_active Expired - Lifetime
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| Publication number | Publication date |
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| WO2002083157A1 (fr) | 2002-10-24 |
| CN1321468A (zh) | 2001-11-14 |
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