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...
| Main Authors: | , , , , |
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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 |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/586 |
| _version_ | 1797875031143874560 |
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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. |
| first_indexed | 2024-04-10T01:41:16Z |
| format | Article |
| id | doaj.art-4eefb4986049415682aad1d8122d8f0c |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2024-04-10T01:41:16Z |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-4eefb4986049415682aad1d8122d8f0c2023-03-13T09:13:57ZrusLLC 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. Fedko4Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»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/586альбумин человекапирогенностьбактериальные эндотоксинылал-тестложноположительные реакцииложноотрицательные реакции |
| 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 альбумин человека пирогенность бактериальные эндотоксины лал-тест ложноположительные реакции ложноотрицательные реакции |
| 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 | альбумин человека пирогенность бактериальные эндотоксины лал-тест ложноположительные реакции ложноотрицательные реакции |
| url | https://www.pharmjournal.ru/jour/article/view/586 |
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