不同葡萄糖浓度全合一营养液体外稳定性评估  

Stability assessment of all-in-one admixtures with high glucose concentrations

作　　者：陆丽娜[1] 汤庆娅[1] 刘晓曼[1] 黄可人[1] 王位苹 王莹[1] 吴江[1] 蔡威[2] 

机构地区：[1]上海交通大学医学院附属新华医院临床营养科,200092 [2]上海市儿科医学研究所上海市小儿消化与营养重点实验室

出　　处：《中华临床营养杂志》2014年第1期18-22,共5页Chinese Journal of Clinical Nutrition

基　　金：上海市卫生局课题（20124y060）;上海市小儿消化与营养重点实验室课题（11DZ2260500）

摘　　要：目的 评估不同时间点添加不同葡萄糖浓度全合一营养液的稳定性,为提高临床应用的安全性提供可靠依据.方法 根据临床应用情况,设计5组不同配方静脉营养液,其中葡萄糖终浓度分别为5％、10％、15％、20％和25％,其他营养素浓度每组相同.配制后的营养液于室温下（25±2）℃储存,分别在0、12、24、48、72 h时观察营养液外观变化,应用扫描电镜测量脂肪颗粒大小,并行营养液渗透浓度和pH值测定.结果 （1）肉眼观察各组营养液配制后0、12、24、48、72 h无颜色变化,未观察到沉淀、分层现象.（2）每组全合一营养液在不同时间点脂肪颗粒平均粒径值差异无统计学意义（F组内=1.255,P=0.324; F组间 =0.025,P=0.998; F交互=1.005,P=0.489）.72 h内,各组脂肪颗粒平均直径均＜0.5 μm,各组均未见到直径＞5.0 μm的脂肪颗粒.（3） 72 h内,所有营养液pH值波动于6.08 ±0.00～6.37±0.01之间.不同时间点5组营养液间pH值比较差异有统计学意义（F组内=3 452.846,P=0.000; F组间=4 655.250,P=0.000; F交互=1.952,P=0.079）.（4） 72 h内,所有营养液平均渗透浓度波动于（609.3±2.3）～（1 625.2±3.5） mOsm/L之间.不同时间点5组营养液间平均渗透浓度比较差异有统计学意义（F组内=176 195.911,P=0.000; F组间=14.732,P=0.006; F交互 =1.203,P=0.343）.结论 全合一营养液中葡萄糖终浓度为5％ ～ 15％时,脂肪颗粒、pH值和渗透压均在安全范围内.Objective To explore the influence of various concentrations of glucose on all-in-one admixtures for fluid-restricted pediatric patients at different time points.Methods Five formulations were designed with 5 different glucose concentrations containing the same nutrient components.The final glucose concentrations of （all-in-one,AIO） admixtures were5% （G5）,10% （G10）,15% （G15）,20% （G20）,and 25%（G25）,respectively.The prepared formulations were preserved at room temperature （25 ± 2） ℃ and the changes in appearance were observed immediately after preparation （0 h） and at 12,24,48 and 72 h after preparation.Electron scanning microscopy was performed to determine fat globule size.The pH and osmolarity were also determined.Results There was no observable alteration in colour and phase separation in any nutrient admixture at any of the observation time points.The diameters of lipid globules showed no significantly meaningful change （P 〉 0.05） in any of the analyzed formulations from 0 to 72 hours （Fintra-group =1.255,P =0.324 ;Finter-sroup =0.025,P=0.998; Finteraction =1.005,P =0.489）.The mean particle sizes of the fat emulsion were 〈 0.5 μm.The mean pH for G5-G25 were between （6.08 ± 0.00） to （6.37 ± 0.01） at the recommended range within 72 hours.The pH was significantly different among all the groups at different time points （Fintra-group =3 452.846,P =0.000 ; Finter-group =4 655.250,P =0.000; Finteraction =1.952,P =0.079）.The mean osmolarities for G5-G25 were （609.3 ± 2.3） mOsm/L to （1 625.2 ± 3.5） mOsm/L.There were significantly different osmolarities among all the groups at different time points （Fintra-group =176 195.911,P =0.000 ;Finter-group =14.732,P =0.006 ; Finteracation =1.203,P =0.343）.Conclusions The lipid globules,pH,and osmolarity of AIOs are within the safe range when their glucose concentrations are 5%-15%.

关 键 词：全合一营养液 葡萄糖浓度 脂肪颗粒 稳定性 

分 类 号：R459.3[医药卫生—治疗学]