Stability assessment of neonatal parenteral nutrition solutions with various amino acid concentrations / 中华临床营养杂志

ABSTRACT

Objective To explore the influence of various concentrations of amino acid on the stability of neonatal parenteral nutrition solutions .Methods Five formulations were designed with 5 different amino acid concentrations containing the same components .The final amino acid concentrations of admixtures were 0%, 1%, 2%, 3%, and 3.5%, respectively .The appearance , pH, and osmolality were observed or meas-ured after preparation (0 hour) and at 12, 24, 48 and 72 hours after preparation.The average size and the size distribution of the lipid globules were also evaluated by laser nanometer particle size analyzer .Results There was no observable alteration in color , phase separation , precipitate , and flocculation in any admixture at any of the observation time points.The mean pH values for all groups were between (5.49 ±0.01) to (6.19 ±0.01) within 72 hours.The mean osmolalities for all groups were between (774 ±3) to (1106 ±13) mOsm/kg.The mean diameters of lipid globules for all groups were between (280.6 ±0.7 ) mm to (332.2 ±2.0 ) nm.The mean polydispersity for all groups were between (0.200 ±0.011) to (0.245 ±0.012).The enrichment of ami-no acid concentration was linked to lower pH ( P=0.000 ) , higher osmolality ( P=0.000 ) and larger average lipid globules size ( P=0.000 ) .However , there was no distinct linear dependence between amino acid concen -tration and polydispersity value ( P=0.628 ) .Conclusion After 72 hours of storage at room temperature , the appearance, pH, osmolality, and the average lipid globules diameter of the parenteral nutrition solutions are within the safe range when the amino acid is not contained or the concentrations are no more than 3.5%.