摘要
目的:考察不同浓度二价阳离子对全肠外营养混合液稳定性影响,为临床提供处方中最佳浓度,确保体系稳定性、安全性。方法:按照全肠外营养液处方和配制原则,分别设定空白组(不含二价阳离子)和4个实验组(包含不同浓度二价阳离子)的5组处方,室温下观察和测定5组营养液0～48 h外观、pH、渗透压摩尔浓度、不溶性微粒和脂肪乳滴聚集情况,比较各组间差异并进行稳定性评价。结果:空白组和各实验组的pH和渗透压分别波动于6.21～6.38和784～813 m Osmol·Kg-1,各组测量值48 h基本稳定;5组处方在48 h内均未检测出≥25μm的微粒;空白组和4个实验组≥10μm的微粒数存在显著性差异(P <0.01),4个实验组随二价阳离子浓度的增高及放置时间的延长,微粒数显著增多,脂肪乳滴聚集明显;实验3组和4组分别在放置24 h和12 h≥10μm微粒数超出药典标准。结论:TPN混合液中二价阳离子的浓度对脂肪乳稳定性有显著影响;常用TPN处方二价阳离子的浓度应尽量控制在5.1 mmol/L内,常温下24 h可确保混合体系的物理稳定性。
Objective: To investigate the effects of divalent cations of different concentration on the stability of total nutrient admixtures(TNA), and to find out the best concentration in the prescription so as to ensure its stability and safety. Methods: Five groups were divided into control group(no bivalent cation) and 4 experimental groups(bivalent cations of different concentrations) according to the prescription and principle of TNA. The appearance, pH,concentration of osmotic pressure Moore, insoluble particles and fat emulsion droplet aggregation were observed at room temperature for 48 h after the solutions were leaving standing. The stability of each group was evaluated and compared.Results: PH and osmotic pressure varied from 6.21 to 6.38 and 784 mOsmol · kg-1 to 813 mOsmol · kg-1 in each group.Values remained stable within 48 h. No particles(≥ 25 μm) were detected in the 5 groups within 48 h. There were significant differences among 5 groups as for the number of particles(≥ 10 μm)(P < 0.01). With the increased concentration of divalent cations and timing of leaving standing, the number of particles increased and fat emulsion droplet aggregated. The number of particles(≥ 10 μm) of experimental group 3 and 4 exceeded the pharmacopoeia standard at 24 h and 12 h. Conclusion: The concentration of divalent cations in TNA has significant effects on the stability of fat emulsion. The concentration of divalent cations in TNA should be controlled less than 5.1 mmol/L. The physical stability of the mixtures can be ensured at room temperature for 24 h.
作者
穆殿平
张凤莹
解晓帅
王春革
MU Dian-ping;ZHANG Feng-ying;XIE Xiao-shuai;WANG Chun-ge(Department of Pharmacy,Tianjin First Center Hospital,Tianjin 300192,China)
出处
《肠外与肠内营养》
CSCD
北大核心
2019年第1期50-55,共6页
Parenteral & Enteral Nutrition
