新生儿肠外营养配方中修饰氨基酸溶液的稳定性试验

IF 0.2 Q4 PHARMACOLOGY & PHARMACY
ChandiniMenon Premakumar, Paul Dwyer, Shakeel Herwitker, AMark Turner, Colin Morgan
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引用次数: 0

摘要

背景:新生儿肠外营养水(PN)配方是由葡萄糖、氨基酸(AAs)和电解质组成。不同的AA溶液被用来制作这些配方。大多数授权产品不能满足早产儿对精氨酸的营养需求。因此,在进行临床疗效测试之前,需要开发含有额外精氨酸的AA溶液,并证明其稳定性。本研究对含有15%精氨酸的改性AA溶液的PN配方进行了试验。目的:本研究旨在设计一种稳定性测试方案,并为被测试的改性PN配方分配保质期。方法:采用外观、pH、旋光度、紫外吸光度、亚可见光粒子数等物理试验和AA法进行化学分析。结果:对PN袋样品进行重新采样存在氧化风险,因此每个测试点对新鲜PN袋进行单一采样是PN稳定性测试试验的最佳实践。AA测定法是保证PN制剂中AA稳定性的可行方法。结论:添加15%精氨酸的改良PN配方在不添加微量元素溶液的情况下,稳定性可达90 d。添加微量元素后,保质期限制为7天。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability testing of modified amino acid solutions in neonatal parenteral nutrition formulations
Context: Aqueous neonatal parenteral nutrition (PN) formulations are made up of glucose, amino acids (AAs), and electrolytes. Different AA solutions are used to make these formulations. Most licensed products do not meet the nutritional needs of preterm neonates specifically for arginine. Therefore, AA solutions with additional arginine need to be developed and proven stable before being tested for clinical efficacy. PN formulations containing modified AA solutions with 15% arginine were tested in this study. Aims: This study aims to design a stability testing protocol and assign a shelf life to the modified PN formulations being tested. Methods: Physical tests including appearance, pH, optical rotation, ultraviolet absorbance, and subvisible particle count tests as well as chemical analysis using AA assay were performed in this study. Results: Resampling of PN bag samples posed a risk for oxidation and hence single sampling of fresh PN bags for each test point is the best practice for PN stability testing trials. AA assay is a feasible method to ensure AA stability in PN formulations. Conclusion: Modified PN formulations with 15% arginine were stable for 90 days without the addition of the trace element solution. Upon the addition of trace elements, the shelf life was limited to 7 days.
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