Otero-Millán Luis, Bea-Mascato Brais, Legido Soto Jose Luis, Martín de la Cruz María Carmen, Martínez-López-De-Castro Noemi, Lago-Rivero Natividad
Pharmacy Department, University Hospital Complex of Vigo, 36312 Vigo, Spain.
NeumoVigo I+i Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, 36312 Vigo, Spain.
Pharmaceuticals (Basel). 2024 Oct 5;17(10):1330. doi: 10.3390/ph17101330.
: Parenteral nutrition (PN) is used when enteral feeding is not possible. It is a complex mixture of nutrients that must meet a patient's needs but can face stability issues, such as lipid emulsion destabilisation and precipitate formation. Stability studies are complex, and the methodologies used are very varied in the literature. In addition, many studies are outdated and use outdated components. This study conducts a stability analysis of PN solutions using optical microscopy. : Samples were prepared according to clinical practice standards and previous studies. We used a counting chamber for optical microscopic observations and different storage conditions (RT, 4 °C 1-14 days). : Precipitates larger than 5 µm were found in 8 out of 14 samples after 14 days of storage at room temperature, and none were observed in refrigerated samples. More lipid globules larger than 5 µm were detected in samples stored at room temperature than in those stored in a refrigerator after 14 days. Additionally, the number of large globules generally increased from day 1 to day 14 in most samples. : The observed precipitates were probably calcium oxalate crystals, the formation of which is possible in PN but is not expected under the usual storage conditions in a hospital environment. Prolonged storage time and storage at room temperature increases the formation of these precipitates. These findings highlight the importance of using filters during both the preparation and administration of PN to prevent large particles from reaching patients.
当无法进行肠内喂养时,会使用肠外营养(PN)。它是一种复杂的营养混合物,必须满足患者的需求,但可能会面临稳定性问题,如脂质乳剂不稳定和沉淀形成。稳定性研究很复杂,文献中使用的方法也非常多样。此外,许多研究已经过时,使用的是过时的成分。本研究使用光学显微镜对PN溶液进行稳定性分析。:根据临床实践标准和先前的研究制备样品。我们使用计数室进行光学显微镜观察,并设置了不同的储存条件(室温、4℃,1 - 14天)。:在室温下储存14天后,14个样品中有8个发现了大于5μm的沉淀物,而冷藏样品中未观察到。14天后,室温储存的样品中检测到的大于5μm的脂质球比冷藏样品中的更多。此外,在大多数样品中,大球的数量通常从第1天到第14天有所增加。:观察到的沉淀物可能是草酸钙晶体,其在PN中可能形成,但在医院环境的通常储存条件下不应出现。延长储存时间和在室温下储存会增加这些沉淀物的形成。这些发现突出了在PN的制备和给药过程中使用过滤器以防止大颗粒进入患者体内的重要性。