儿科肠外营养液稳定性及影响因素研究

Stability and Influencing Factors of Pediatric Parenteral Nutrition Solution

目的:研究儿科肠外营养液的稳定性,探讨影响稳定性的相关因素,为提高临床应用的安全性提供可靠依据。方法:随机抽取儿科肠外营养液,肉眼观察其外观,采用动态光散射法测定脂肪乳平均粒径大小(MDS),采用光阻法测定脂肪乳粒径>5μm的乳粒百分比(PFAT5)及颗粒分布。采用多元回归分析探讨肠外营养液稳定性的影响因素。结果:(1)长链脂肪乳组(n=13)MDS为274. 870(270. 495,281. 665) nm,PFAT5为0. 003 40 (0. 002 04,0. 005 88);多种油脂肪乳组(n=6) MDS为308. 348(307. 105,314. 250) nm,PFAT5为0. 003 91(0. 001 82,0. 005 38)。两组脂肪乳MDS比较差异有统计学意义(P<0. 01),PFAT5比较差异无统计学意义(P>0. 05)。(2)稳定性影响因素分析(n=19):多元回归分析提示氨基酸浓度和PFAT5值之间存在线性关系(P<0. 01);尚未发现脂肪乳浓度、葡萄糖浓度和一价、二价阳离子电解质浓度与PFAT5之间存在线性关系(P>0. 05)。(3)肠外营养液的颗粒分布主要集中在1. 8~5. 0μm,尾端同时存在>5. 0μm的大颗粒分布。结论:肠外营养液中含长链脂肪乳剂的稳定性优于多种油脂肪乳,氨基酸对肠外营养液的稳定性具有一定的保护作用。基于全合一营养液的粒径大小与颗粒分布,为提高肠外营养液临床应用的安全性和规范性,建议采用1. 2μm的营养液过滤器。

Objective: To research the stability of pediatric parenteral nutrition solution,and explore the influencing factors of stability,so as to provide reliable basis for improving the safety of clinical application. Methods: Pediatric parenteral nutrient solution was randomly selected and its appearance was observed by naked eyes. Dynamic light scattering method was used to determine the mean droplet size( MDS) of lipid emulsion,and light blocking method was used to determine the percentage of fat residing in globules >5 μm( PFAT5) and distribution of particle size. Multiple regression analysis was used to explore the influencing factors of stability of parenteral nutrition. Results:( 1) The MDS of long chain lipid emulsion group( n = 13) was 274. 870( 270. 495,281. 665) nm,PFAT5 was0. 003,40( 0. 002,04,0. 005,88);the MDS of multi-oil lipid emulsion group( n = 6) was 308. 348( 307. 105,314. 250) nm,PFAT5 was 0. 003,91( 0. 001,82,0. 005,38);the difference in MDS of lipid emulsion between two groups was statistically significant( P <0. 01),while the difference in PFAT5 was not statistically significant( P>0. 05).( 2) Influencing factor of stability( n = 19) : Multiple regression analysis suggested that there was linear relationship between amino acid concentration and PFAT5 value( P<0. 01). No linear relationship was found in the lipid emulsion concentration, glucose concentration and monovalent, divalent cation electrolyte concentration and PFAT5( P>0. 05).( 3) The particle size distribution of parenteral nutrition mainly confined from 1. 8 to 5. 0 μm,with a large-diameter droplet tail > 5. 0 μm. Conclusion: Parenteral nutrition with long chain lipid emulsion is more stable than that with multi-oil lipid emulsion,and amino acids provide a certain degree of protection to the stability. Based on the droplet size and the particle size distribution in all-in-one nutrition solution,1. 2 μm filter is recommended to improve the safety and specification of parenteral nutrition.