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

作　　者：Anne-Laure Yailian Céline Serre Justine Fayard Marina Faucon Patrick Thomaré Samira Filali Christine Pivot Florence Vételé Fabrice Pirot Emmanuelle Olivier 

机构地区：[1]Service Pharmaceutique,Plateforme Fripharm,Groupe Hospitalier Centre Edouard Herriot,Hospices Civils de Lyon [2]Laboratoire de Recherche et Développement de Pharmacie Galénique Industrielle,UMR 5305,Plateforme Fripharm,Faculté de Pharmacie,Université Claude Bernard Lyon 1,8 [3]Service Pharmaceutique,Site H?tel-Dieu,Centre Hospitalo-Universitaire de Nantes,1,place Alexis Ricordeau [4]Service pharmaceutique,Groupement Hospitalier Est,Hospices Civils de Lyon

出　　处：《Journal of Pharmaceutical Analysis》2019年第2期83-90,共8页药物分析学报（英文版）

摘　　要：Standard parenteral nutrition solutions are mixtures comprising interacting components that may degrade 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 microbiological 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 4 months 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.Standard parenteral nutrition solutions are mixtures comprising interacting components that may degrade 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 microbiological 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 4 months 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.

关 键 词：STABILITY-INDICATING method study PARENTERAL nutrition NEONATOLOGY Amino ACIDS High-performance liquid CHROMATOGRAPHIC 

分 类 号：R[医药卫生]