A method for the early evaluation of the effects of storage and additives on the stability of parenteral fat emulsions.

A method for the early evaluation of the effects of storage and additives on the stability of parenteral fat emulsions.
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一种早期评价储存和添加剂对肠外脂肪乳稳定性影响的方法。

DOI:
10.1023/a:1018941801368
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发表时间:
1993
影响因子:
3.7
通讯作者:
Anderson,BD
Anderson,BD
中科院分区:
医学3区
文献类型:
--
作者:
Li,J;Caldwell,KD;Anderson,BD

文献摘要

相似文献

沉积场流分馏(SedFFF)和光子相关光谱(PCS)的结合被证明提供了一种详细的记录,存在于脂肪乳剂中,通常用于肠外营养。所提出的技术已用于记录特定乳液(Liposyn-II)的尺寸分布数据,证明其高稳定性和批次间均匀性。该技术还能够证明添加少量电解质[0.45% (w/v) NaCl, 0.05% (w/v) CaCl2]如何使乳状液不稳定,这表明在使用全肠外营养(TPN)混合物时要谨慎。相比之下,与人血清1:1的混合物没有引起Liposyn-II不稳定的迹象。使用乳液作为亲脂性药物的载体,需要将药物溶液加入非水溶剂中,如二甲基亚砜(DMSO)。这种溶剂的不稳定作用导致液滴聚结在添加10% (v/v)后的3-5天内变得严重,而添加5% (v/v)的液滴在10天内达到相同的聚结水平。
The combination of sedimentation field-flow fractionation (SedFFF) and photon correlation spectroscopy (PCS) is shown to provide a detailed record of the droplet sizes present in fat emulsions commonly used in parenteral nutrition. The technique presented has been used to record size distribution data for a particular emulsion (Liposyn-II), demonstrating its high stability and lot-to-lot uniformity. The technique is also able to demonstrate how additions of small amounts of electrolytes [0.45% (w/v) NaCl, 0.05% (w/v) CaCl2] tend to destabilize the emulsion, suggesting some caution in the use of total parenteral nutrition (TPN) mixtures. In contrast, a 1:1 mixture with human serum caused no sign of instability in the Liposyn-II. Using the emulsion as a carrier for lipophilic drugs necessitates adding solutions of the drug in nonaqueous solvents, such as DMSO (dimethyl sulfoxide). This solvent's destabilizing effect results in a droplet coalescence that becomes severe after 3–5 days following a 10% (v/v) addition, while a 5% (v/v) addition reaches the same level of coalescence in 10 days.