Department of Pharmacy, Affiliated Hospital of Qingdao University, Qingdao, China.
Ann Palliat Med. 2021 Dec;10(12):12244-12250. doi: 10.21037/apm-21-3353.
The purpose of this study was to evaluate the effects of monovalent and divalent cations on the stability of a fat emulsion (Lipovenoes MCT) in total nutrient admixtures (TNAs) by testing the percentage of fat residing in globules >5 µm (PFAT5) values.
TNAs with different combinations of glucose (5% and 10%), amino acids (3.35 and 4.5 g/100 mL), Na+/K+ (100/39 mmol/L), Mg2+ (3.4 and 2.7 mmol/L), and fat emulsion (2.4%) were tested in triplicate at room temperature. The pH, mean droplet size (MDS), and PFAT5 were assessed at 0, 6, 12, 24, 36, and 48 h.
In all seven groups, the TNA globule distribution was uniform, the pH value fluctuated in the range of 5.93-6.06, and the MDS met the limit of the United States Pharmacopeia (USP) within 48 h. The PFAT5 value of the control group 0 without electrolytes was the lowest; group 1 added monovalent ions of 139 mmol/L was significantly higher (P<0.05) but without exceed the USP limit after 48 h. Groups 2 and 3 added Mg2+ 3.4 and 2.7 mmol/L respectively, based on group 1. Group 4 increased the amino acid concentration from 3.35% to 4.5% based on group 2, and group 5 reduced the glucose concentration from 10% to 5% based on group 4. Group 6 removed monovalent ions and retained only Mg2+ based on group 5. The PFAT5 values of group 2, 3, 4, and 5 exceeded the limit after 6 h and group 6 after 12 h. There was no statistical difference between group 2 and 4 (P>0.05) or between group 4 and 5 (P>0.05).
When the concentration of glucose is 10-25% and the amino acid is 2.5-4.5%, The addition of monovalent ions affects the stability of fat emulsion in TNAs, however when the concentrations of Na+ ≤100 mmol/L and K+ ≤39 mmol/L, the PFAT5 value will not exceed the USP limit within 24 h. Mg2+ has a significant effect, the PFAT5 value will exceed the USP limit after 6 h when the concentration ≥2.7 mmol/L, which may cause potential safety hazards.
本研究旨在通过检测大于 5μm 油滴百分比（PFAT5）值来评估单价和二价阳离子对全营养混合液（TNA）中脂肪乳剂稳定性的影响。
在室温下，对含有不同葡萄糖（5%和 10%）、氨基酸（3.35 和 4.5g/100mL）、Na+/K+（100/39mmol/L）、Mg2+（3.4 和 2.7mmol/L）和脂肪乳剂（2.4%）组合的 TNA 进行重复测试。在 0、6、12、24、36 和 48 小时时评估 pH 值、平均液滴大小（MDS）和 PFAT5。
在所有七组中，TNA 液滴分布均匀，pH 值在 5.93-6.06 范围内波动，MDS 在 48 小时内符合美国药典（USP）的限制。不添加电解质的对照组 0 的 PFAT5 值最低；添加 139mmol/L 单价离子的组 1 显著升高（P<0.05），但 48 小时后未超过 USP 限制。分别添加 3.4mmol/L 和 2.7mmol/L Mg2+的组 2 和 3 基于组 1。基于组 2 将氨基酸浓度从 3.35%增加到 4.5%的组 4，以及基于组 4 将葡萄糖浓度从 10%降低到 5%的组 5。基于组 5 仅保留 Mg2+并去除单价离子的组 6。组 2、3、4 和 5 的 PFAT5 值在 6 小时后超过限制，组 6 在 12 小时后超过限制。组 2 和 4（P>0.05）或组 4 和 5（P>0.05）之间没有统计学差异。
当葡萄糖浓度为 10-25%，氨基酸浓度为 2.5-4.5%时，添加单价离子会影响 TNA 中脂肪乳剂的稳定性，然而当 Na+浓度≤100mmol/L 和 K+浓度≤39mmol/L 时，PFAT5 值在 24 小时内不会超过 USP 限制。Mg2+ 具有显著影响，当浓度≥2.7mmol/L 时，PFAT5 值在 6 小时后会超过 USP 限制，这可能会造成潜在的安全隐患。
