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![]() PANTELEI, Olga, ŞTEFĂNEŢ, Tatiana, TREAPIŢINA, Tatiana. Biological standardization of drugs. In: Revista de Ştiinţe ale Sănătăţii din Moldova, 2022, nr. 3 An.1(29), p. 505. ISSN 2345-1467. |
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Revista de Ştiinţe ale Sănătăţii din Moldova | ||||||
Numărul 3 An.1(29) / 2022 / ISSN 2345-1467 | ||||||
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Pag. 505-505 | ||||||
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Rezumat | ||||||
Background. Biological methods of controlling the quality of drugs are used when it is impossible to draw conclusions about the quality of medicines using physical and chemical methods, or these methods are not sensitive enough. Objective of the study. Study of the specialized bibliography on the evaluation of biological methods of analysis and their importance in drug standardization. Material and Methods. Chemical control of the quality of medicines in some cases is unacceptable. For example, it is impossible to determine by chemical methods certain quality parameters of herbal extracts (tinctures, etc.) or animal organs. In this case, the tests are performed on animals, individual isolated organs, and groups of cells, as well as on certain micro-organism strains. Results. Drugs came from chemical synthesis are well defined and relatively strong, benefiting from a high level of purity. Biological products, on the other hand, have complex properties, are molecules with mass and large molecular size. According to the results of biological standardization, the quality and activity of the medicinal products are determined by assessing the specific pharmacological effect of the test substance compared to the standard medicinal product. The specific activity of a test substance is expressed in units of action or international units, compared to the international standard of the drug. Conclusion. According to Eur.Ph. 10.0, biological standardization of drugs is performed in two main directions: biological testing (sterility control, microbial contamination, etc.) and quantitative analysis (biological dosing of heparin, biological dosing of insulin, etc.). |
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Cuvinte-cheie biological methods of analysis, biological standardization., metode biologice de analiză, standardizarea biologică |
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