高浓度电解质对肠外营养多腔袋中脂肪乳稳定性的影响

The effects of high concentration electrolyte on fat emulsion stability in multi-chambered bag parenteral nutrition

目的探讨高浓度电解质对肠外营养多腔袋中脂肪乳稳定性的影响,为临床用药安全性提供可靠依据。方法将组成相同的高浓度电解质肠外营养多腔袋处方分为试验组和对照组,试验组添加水溶性维生素、脂溶性维生素、甘油磷酸钠和微量元素,对照组不添加。放置于室温,分别于0、12、24、36、48、60、72、168 h时观察两组溶液外观变化并测定pH值、渗透压摩尔浓度和平均粒径。结果两组溶液外观无絮凝或油水分离现象,试验组的pH值为5.73~5.83,对照组为5.52~5.57,比较差异有统计学意义(P<0.001);试验组0 h和168 h相比,差异有统计学意义(P<0.001);对照组0 h和168 h相比,差异有统计学意义(P<0.001)。试验组渗透压摩尔浓度为1076~1117 mOsmol/kg,对照组为1072~1104 mOsmol/kg,比较差异有统计学意义(P=0.012),组内不同时间点比较无统计学意义(P>0.05)。试验组的平均粒径为296.1~310.9 nm,对照组为296.6~334.9 nm,比较差异无统计学意义(P=0.096),组内不同时间点比较无统计学意义(P>0.05)。结论高浓度电解质肠外营养液室温放置168 h,其脂肪乳的平均粒径基本稳定。水溶性维生素、脂溶性维生素、甘油磷酸钠和微量元素的添加对脂肪乳稳定性无显著影响。

Objective To investigate the effect of high concentration electrolyte on fat emulsion stability in multi-chambered bag parenteral nutrition,and to protect clinical drug safety.Methods Multi-chambered bag parenteral nutrition with the same composition containing high concentration electrolyte were used,except for that water-soluble vitamins,fat-soluble vitamins,sodium glycerophosphate and trace elements were supplemented in the experimental group only.The appearance,pH,osmolality and average particle size were examined at 0,12,24,36,48,60,72,and 168 hours after preparation under room temperature.Results There was no flocculation or oil-water separation in both groups.The pH value was 5.73 to 5.83 for the experimental group,while that was 5.52 to 5.57 for the control group(P<0.001).For both groups,the comparison between 0 and 168 hours showed significant differences(P<0.001).The osmolality was significantly different between the experimental group(1076-1117 mOsmol/kg)and the control group(1072-1104 mOsmol/kg,P=0.012),but showed no statistical significant difference across examined time points within each group(P>0.05).The average particle size was 296.1 to 310.9 nm for the experimental group,and 296.6 to 334.9 nm for the control group,showing no statistical significant difference(P=0.096).The particle size showed no profound changes over time in both groups(P>0.05).Conclusions The average particle size of fat emulsion in multi-chambered bag parenteral nutrition were basically stable over 168 hours after preparation under room temperature.The addition of water-soluble vitamins,fat-soluble vitamins,sodium glycerophosphate and trace elements had no significant impact on the stability of fat emulsion.