PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS
The problem was considered to determine bacterial endotoxins in human albumin drugs. To improve the safety of medicines the option of dual control was recommended, which includes the rabbit pyrogen test and determining bacterial endotoxins by the LAL-test. The causes described justify the need for d...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/586 |
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| author | T. V. Kukunina A. G. Israfilov M. L. Romanenkova R. S. Gaynullina L. G. Fedko |
| author_facet | T. V. Kukunina A. G. Israfilov M. L. Romanenkova R. S. Gaynullina L. G. Fedko |
| author_sort | T. V. Kukunina |
| collection | DOAJ |
| description | The problem was considered to determine bacterial endotoxins in human albumin drugs. To improve the safety of medicines the option of dual control was recommended, which includes the rabbit pyrogen test and determining bacterial endotoxins by the LAL-test. The causes described justify the need for dual control of albumin drugs on the content of the pyrogens/bacterial endotoxins, the main of which is the special nature of the albumin molecule reversibly binding a large number of compounds, including endotoxins. There were given known causes of false-positive and false-negative reactions of the LAL-test, and sample preparation variant including dilution, temperature treatment and the use of special dispersing agents. |
| format | Article |
| id | doaj-art-4eefb4986049415682aad1d8122d8f0c |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-4eefb4986049415682aad1d8122d8f0c2025-08-20T03:59:20ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0102100109586PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINST. V. Kukunina0A. G. Israfilov1M. L. Romanenkova2R. S. Gaynullina3L. G. Fedko4Branch of Stock Company «Scientific-production Association «Microgen» in Ufa «Immunopreparat»Branch of Stock Company «Scientific-production Association «Microgen» in Ufa «Immunopreparat»Branch of Stock Company «Scientific-production Association «Microgen» in Ufa «Immunopreparat»Branch of Stock Company «Scientific-production Association «Microgen» in Ufa «Immunopreparat»Branch of Stock Company «Scientific-production Association «Microgen» in Ufa «Immunopreparat»The problem was considered to determine bacterial endotoxins in human albumin drugs. To improve the safety of medicines the option of dual control was recommended, which includes the rabbit pyrogen test and determining bacterial endotoxins by the LAL-test. The causes described justify the need for dual control of albumin drugs on the content of the pyrogens/bacterial endotoxins, the main of which is the special nature of the albumin molecule reversibly binding a large number of compounds, including endotoxins. There were given known causes of false-positive and false-negative reactions of the LAL-test, and sample preparation variant including dilution, temperature treatment and the use of special dispersing agents.https://www.pharmjournal.ru/jour/article/view/586human albuminpyrogenicitybacterial endotoxinlal-testfalse-positive reactionsfalse-negative reactions |
| spellingShingle | T. V. Kukunina A. G. Israfilov M. L. Romanenkova R. S. Gaynullina L. G. Fedko PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS Разработка и регистрация лекарственных средств human albumin pyrogenicity bacterial endotoxin lal-test false-positive reactions false-negative reactions |
| title | PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS |
| title_full | PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS |
| title_fullStr | PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS |
| title_full_unstemmed | PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS |
| title_short | PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS |
| title_sort | peculiarities of control of human albumin drugs on the content of bacterial endotoxins |
| topic | human albumin pyrogenicity bacterial endotoxin lal-test false-positive reactions false-negative reactions |
| url | https://www.pharmjournal.ru/jour/article/view/586 |
| work_keys_str_mv | AT tvkukunina peculiaritiesofcontrolofhumanalbumindrugsonthecontentofbacterialendotoxins AT agisrafilov peculiaritiesofcontrolofhumanalbumindrugsonthecontentofbacterialendotoxins AT mlromanenkova peculiaritiesofcontrolofhumanalbumindrugsonthecontentofbacterialendotoxins AT rsgaynullina peculiaritiesofcontrolofhumanalbumindrugsonthecontentofbacterialendotoxins AT lgfedko peculiaritiesofcontrolofhumanalbumindrugsonthecontentofbacterialendotoxins |