Volume 9 Issue 2
Apr.  2019
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Anne-Laure Yailian, Céline Serre, Justine Fayard, Marina Faucon, Patrick Thomaré, Samira Filali, Christine Pivot, Florence Vételé, Fabrice Pirot, Emmanuelle Olivier. Production and stability study of a hospital parenteral nutrition solution for neonates[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 83-90.
Citation: Anne-Laure Yailian, Céline Serre, Justine Fayard, Marina Faucon, Patrick Thomaré, Samira Filali, Christine Pivot, Florence Vételé, Fabrice Pirot, Emmanuelle Olivier. Production and stability study of a hospital parenteral nutrition solution for neonates[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 83-90.

Production and stability study of a hospital parenteral nutrition solution for neonates

  • Publish Date: Apr. 10, 2019
  • Standard parenteral nutrition solutions are mixtures comprising interacting components that may de-grade themselves over time. The objective of this study was to investigate the physicochemical and microbiological stability of a hospital preparation for parenteral nutrition in neonatology. The analyses were performed throughout the storage of the preparations at 2–8 °C (up to 4 months). The extent of stability was based on the determination of amino acids dosage, visual and physicochemical properties (glucose and electrolytes concentrations, pH and osmolality measurements, particle counting) and mi-crobiological analysis (sterility test). A thermal degradation of ascorbic acid was conducted to evaluate the antioxidant properties of the parenteral mixture. Physicochemical and microbiological controls were found to comply with the specifications. Amino acids showed a good stability throughout the 4months storage except for cysteine, which was progressively degraded to cystine, conferring a yellow coloration to parenteral solutions. Parenteral nutrition standards solutions remain stable for 4 months at 2–8 °C, ensuring safe administration in preterm infants.
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