不同氨基酸浓度对新生儿肠外营养液稳定性的影响  

Stability assessment of neonatal parenteral nutrition solutions with various amino acid concentrations

作　　者：顾莹芬 洪莉[2] 陈敏玲 黄诗颖 吴娟 

机构地区：[1]上海交通大学医学院附属上海儿童医学中心药剂科,200127 [2]上海交通大学医学院附属上海儿童医学中心临床营养科,200127

出　　处：《中华临床营养杂志》2017年第2期72-77,共6页Chinese Journal of Clinical Nutrition

摘　　要：目的 探讨不同氨基酸终浓度对新生儿肠外营养液稳定性的影响.方法 设计5组不同氨基酸终浓度（分别为0、1%、2%、3%和3.5%）的新生儿肠外营养液,每组各3袋,在配制后0、12、24、48、72 h时进行外观考察,测定pH值和渗透压,应用激光纳米粒度仪检测脂肪乳粒径大小和粒度分布.结果 5组肠外营养液在配制后0、12、24、48、72h时肉眼观察外观颜色无变化,无分层、 沉淀、 絮凝、 挂壁现象.在72 h内,5组肠外营养液pH值波动于（5.49±0.01）-（6.19±0.01）,渗透压波动于（774±3）-（1106±13）mOsm/kg,平均粒径大小波动于（280.6±0.7）-（332.2±2.0）nm,多分散指数值波动于（0.200±0.011）-（0.245±0.012）.随着氨基酸浓度的增高,5组肠外营养液的pH值逐渐下降（P=0.000）,渗透压值逐渐升高（P=0.000）,平均粒径大小逐渐增大（P=0.000）,多分散指数值未呈现线性变化趋势（P=0.628）.结论 在室温下72 h内,未添加氨基酸或氨基酸终浓度≤3.5%时,新生儿肠外营养液的外观、pH值、 渗透压和脂肪乳粒径大小均在安全范围内.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 measured 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 amino 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%.

关 键 词：氨基酸 脂肪乳剂 静脉注射用 稳定性 新生儿肠外营养液 

分 类 号：R459.3[医药卫生—治疗学] R722.1[医药卫生—临床医学]