Analysis of Hemolytic Properties of Nanoparticles: Version 4
- PMID: 39012990
- Bookshelf ID: NBK604925
- DOI: 10.17917/V9AP-D094
Analysis of Hemolytic Properties of Nanoparticles: Version 4
Excerpt
Erythrocytes comprise approximately 45% of whole blood by volume. Hemolysis refers to the damage of red blood cells leading to the release of erythrocyte intracellular content into blood plasma. When it occurs, in vivo hemolysis can lead to anemia, jaundice and other pathological conditions, which may become life threatening. Hemoglobin is a dominant protein carried by erythrocytes. When it is contained inside the cell it plays a key role in carrying oxygen to other cells and tissues. However, extracellular hemoglobin is toxic and may affect vascular, myocardial, renal and central nervous system functions. Therefore, all medical devices and drugs which come in contact with blood are required to be tested for potential hemolytic properties.
Sections
- 1. Introduction
- 2. Principles
- 3. Reagents, Materials, and Equipment
- 4. Preparation of Standards and Controls
- 5. Preparation of Blood and Study Samples
- 6. Experimental Procedure
- 7. Calculations and Result Interpretation
- 8. Acceptance Criteria
- 9. Example of Nanoparticle Interference
- 10. References
- 11. Abbreviations
- 12. Appendix
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References
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- Malinauskas R.A. Plasma hemoglobin measurement techniques for the in vitro evaluation of blood damage called by medical devices. Artif. Organs 1997, 21:1255–1267 - PubMed
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- ASTM standard practice F 756-00. Assessment of hemolytic properties of materials.
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- ASTM E2524-08 (2013) Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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- CDER, Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers, 2005.
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