Biological potency evaluation and physicochemical characterization of unfractionated heparins
Autor(a) principal: | |
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Data de Publicação: | 2009 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Revista brasileira de hematologia e hemoterapia (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000500009 |
Resumo: | Unfractionated heparins are used clinically as anticoagulants. The biological potency of thirteen samples of raw material and pharmaceutical formulations were assessed utilizing the 5th International Standard of heparin using the sheep plasma coagulation inhibition assay, activated partial thromboplastin time, anti-factor Xa assay, and anti-factor IIa assay, resulting in mean potencies of 101.15%, 96.15%, 98.15% and 99.37%, respectively. The samples were also evaluated by the protamine neutralization test giving results within the range of 92 - 138 IU/mg. The anti-factor IIa assay was performed showing reproducibility and significant correlation with the pharmacopoeial assays, thus demonstrating it to be a feasible alternative to the sheep plasma coagulation inhibition assay. Moreover, an analysis by nuclear magnetic resonance and capillary electrophoresis showed some peaks attributable to oversulfated chondroitin sulfate. The results show that batch-to-batch variations and the quality of samples contributed to improvements in the quality control of pharmaceutical products and to assure the safe use and clinical efficacy of this biological medicine. |
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Biological potency evaluation and physicochemical characterization of unfractionated heparinsUnfractionated heparinsanti-factor Xaactivated partial thromboplastin timeanti-factor IIaprotaminecapillary electrophoresisUnfractionated heparins are used clinically as anticoagulants. The biological potency of thirteen samples of raw material and pharmaceutical formulations were assessed utilizing the 5th International Standard of heparin using the sheep plasma coagulation inhibition assay, activated partial thromboplastin time, anti-factor Xa assay, and anti-factor IIa assay, resulting in mean potencies of 101.15%, 96.15%, 98.15% and 99.37%, respectively. The samples were also evaluated by the protamine neutralization test giving results within the range of 92 - 138 IU/mg. The anti-factor IIa assay was performed showing reproducibility and significant correlation with the pharmacopoeial assays, thus demonstrating it to be a feasible alternative to the sheep plasma coagulation inhibition assay. Moreover, an analysis by nuclear magnetic resonance and capillary electrophoresis showed some peaks attributable to oversulfated chondroitin sulfate. The results show that batch-to-batch variations and the quality of samples contributed to improvements in the quality control of pharmaceutical products and to assure the safe use and clinical efficacy of this biological medicine.Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular2009-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000500009Revista Brasileira de Hematologia e Hemoterapia v.31 n.5 2009reponame:Revista brasileira de hematologia e hemoterapia (Online)instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)instacron:ABHHTC10.1590/S1516-84842009005000074info:eu-repo/semantics/openAccessDalmora,Sérgio L.Souto,Ricardo B.Silva,Lucélia M.Lana,Aline D.Schutkoski,RenatoVaccari,Silvana F.eng2009-12-16T00:00:00Zoai:scielo:S1516-84842009000500009Revistahttp://www.rbhh.org/pt/archivo/https://old.scielo.br/oai/scielo-oai.phpsbhh@terra.com.br||secretaria@rbhh.org1806-08701516-8484opendoar:2009-12-16T00:00Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)false |
dc.title.none.fl_str_mv |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
title |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
spellingShingle |
Biological potency evaluation and physicochemical characterization of unfractionated heparins Dalmora,Sérgio L. Unfractionated heparins anti-factor Xa activated partial thromboplastin time anti-factor IIa protamine capillary electrophoresis |
title_short |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
title_full |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
title_fullStr |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
title_full_unstemmed |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
title_sort |
Biological potency evaluation and physicochemical characterization of unfractionated heparins |
author |
Dalmora,Sérgio L. |
author_facet |
Dalmora,Sérgio L. Souto,Ricardo B. Silva,Lucélia M. Lana,Aline D. Schutkoski,Renato Vaccari,Silvana F. |
author_role |
author |
author2 |
Souto,Ricardo B. Silva,Lucélia M. Lana,Aline D. Schutkoski,Renato Vaccari,Silvana F. |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Dalmora,Sérgio L. Souto,Ricardo B. Silva,Lucélia M. Lana,Aline D. Schutkoski,Renato Vaccari,Silvana F. |
dc.subject.por.fl_str_mv |
Unfractionated heparins anti-factor Xa activated partial thromboplastin time anti-factor IIa protamine capillary electrophoresis |
topic |
Unfractionated heparins anti-factor Xa activated partial thromboplastin time anti-factor IIa protamine capillary electrophoresis |
description |
Unfractionated heparins are used clinically as anticoagulants. The biological potency of thirteen samples of raw material and pharmaceutical formulations were assessed utilizing the 5th International Standard of heparin using the sheep plasma coagulation inhibition assay, activated partial thromboplastin time, anti-factor Xa assay, and anti-factor IIa assay, resulting in mean potencies of 101.15%, 96.15%, 98.15% and 99.37%, respectively. The samples were also evaluated by the protamine neutralization test giving results within the range of 92 - 138 IU/mg. The anti-factor IIa assay was performed showing reproducibility and significant correlation with the pharmacopoeial assays, thus demonstrating it to be a feasible alternative to the sheep plasma coagulation inhibition assay. Moreover, an analysis by nuclear magnetic resonance and capillary electrophoresis showed some peaks attributable to oversulfated chondroitin sulfate. The results show that batch-to-batch variations and the quality of samples contributed to improvements in the quality control of pharmaceutical products and to assure the safe use and clinical efficacy of this biological medicine. |
publishDate |
2009 |
dc.date.none.fl_str_mv |
2009-01-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000500009 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000500009 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S1516-84842009005000074 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular |
publisher.none.fl_str_mv |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular |
dc.source.none.fl_str_mv |
Revista Brasileira de Hematologia e Hemoterapia v.31 n.5 2009 reponame:Revista brasileira de hematologia e hemoterapia (Online) instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC) instacron:ABHHTC |
instname_str |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC) |
instacron_str |
ABHHTC |
institution |
ABHHTC |
reponame_str |
Revista brasileira de hematologia e hemoterapia (Online) |
collection |
Revista brasileira de hematologia e hemoterapia (Online) |
repository.name.fl_str_mv |
Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC) |
repository.mail.fl_str_mv |
sbhh@terra.com.br||secretaria@rbhh.org |
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1754213109943238656 |