Pharmacy Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Faculty of Pharmacy and Food Sciences, Universitat de Barcelona, Barcelona, Spain.
Nutr Clin Pract. 2018 Oct;33(5):694-700. doi: 10.1002/ncp.10013. Epub 2018 Feb 21.
Parenteral nutrition (PN) is frequently needed in neonatal intensive care. The use of standard PN has emerged as an easy-to-prescribe approach that allows one to have on-site, ready-to-use PN. The aim of this study was to test the physicochemical stability and sterility of 2 specific PN solutions as well as simulate Y-site compatibility with lipid injectable emulsions (ILE).
Our study considered 2 standard ILE-free PN solutions according to neonatal weight. These solutions were prepared in duplicate and stored at 4°C. The following physicochemical parameters were tested: visual alterations, turbidity, pH, osmolarity, and calcium concentration. Sterility was assessed by means of agar blood culture and glucose concentration determination. In addition, we assessed the stability of simulated Y-site admixtures. For each standard ILE-free PN solution, 2 3-in-1 PN admixtures were designed, considering extreme values of fluid requirements (50 and 150 ml/kg/d) and a fat supply of 2 g/kg/24 h. The physicochemical parameters tested were phase separation and fat mean droplet size distribution.
No alterations were detected by visual inspection. Calcium concentrations, turbidity, pH, and osmolarity values remained stable in all the determinations. All agar blood cultures were negative and glucose concentration was constant over time. Physical stability of simulated Y-site admixtures was considered acceptable as mean droplet size distribution remained below 500 nm in all the emulsions.
The 2 tested standard ILE-free PN solutions for neonates are physicochemically stable and sterile for 31 days under refrigeration (4°C). These solutions are also stable in case of Y-site administration with ILE at the conditions tested.
在新生儿重症监护中，经常需要肠外营养（PN）。标准 PN 的使用已成为一种易于开处方的方法，可以在现场提供即用型 PN。本研究旨在测试两种特定 PN 溶液的物理化学稳定性和无菌性，并模拟与脂溶性注射乳剂（ILE）的 Y 型部位相容性。
我们的研究考虑了根据新生儿体重配制的两种标准 ILE 免费 PN 溶液。这些溶液一式两份制备并储存在 4°C。测试了以下物理化学参数：外观变化、浊度、pH 值、渗透压和钙浓度。通过琼脂血培养和葡萄糖浓度测定评估无菌性。此外，我们还评估了模拟 Y 型部位混合物的稳定性。对于每种标准 ILE 免费 PN 溶液，考虑到液体需求的极值（50 和 150 ml/kg/d）和 2 g/kg/24 h 的脂肪供应，设计了 2 种 3-in-1 PN 混合物。测试的物理化学参数为相分离和脂肪平均液滴尺寸分布。
目视检查未发现任何变化。在所有测定中，钙浓度、浊度、pH 值和渗透压值均保持稳定。所有琼脂血培养均为阴性，葡萄糖浓度随时间保持不变。模拟 Y 型部位混合物的物理稳定性被认为是可接受的，因为所有乳液的平均液滴尺寸分布均保持在 500nm 以下。
在冷藏（4°C）条件下，两种测试的新生儿 ILE 免费 PN 溶液在 31 天内具有物理化学稳定性和无菌性。在测试条件下，这些溶液与 ILE 在 Y 型部位给药时也稳定。
