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儿科肠外营养液中无机钙的存在情况。

The presence of inorganic calcium in pediatric parenteral admixtures.

作者信息

Watrobska-Swietlikowska Dorota, Szlagatys-Sidorkiewicz Agnieszka, MacLoughlin Ronan

机构信息

Department of Pharmaceutical Technology, Medical University of Gdansk, Poland.

出版信息

Nutr Hosp. 2018 Jan 10;35(1):11-18. doi: 10.20960/nh.1340.

Abstract

INTRODUCTION

Newborn infants and small children require large amounts of calcium and phosphate in a low volume of solution which can increase the risk of precipitation of calcium phosphate. Calcium gluconate is the predominant calcium salt form employed in parenteral nutrition (PN) compounding due to its solubility profile with phosphate. Unfortunately, calcium gluconate contains higher levels of aluminum contamination than calcium chloride, resulting in an increased potential for aluminum toxicity in patients receiving traditional PN. The physicochemical stability of 30 total parenteral admixtures containing inorganic calcium salts was evaluated.

METHODS

Parenteral admixtures were prepared in one-chamber ethylene vinyl acetate bags: amino acids, glucose, electrolytes including only inorganic calcium salt and 20% (w/w) lipid emulsions (SMOFlipid®, Omegaven® or Lipofundin MCT/LCT®) were placed together in a one chamber bag. Admixtures were stored at +4 °C for up to eight days after preparation. Visual observations, globule size distribution (using optical microscopy, laser diffraction and photon correlation spectroscopy methods), pH analysis and zeta potential measurements were performed.

RESULTS

The physicochemical stability of 29 of parenteral admixtures in the presence of inorganic calcium salt was confirmed. One admixture was deemed unsuitable for use in clinical practice due to the coalescence of oil droplets.

CONCLUSION

Despite the presence of inorganic calcium salts, pediatric parenteral admixtures were stable up to eight days of storage. Due to presence of multiple components and a high risk of incompatibilities, physicochemical studies should be performed for each admixture before use in clinical practice.

摘要

引言

新生儿和幼儿需要在少量溶液中摄入大量钙和磷,这会增加磷酸钙沉淀的风险。葡萄糖酸钙因其与磷酸盐的溶解性,是肠外营养(PN)配制中使用的主要钙盐形式。不幸的是,葡萄糖酸钙所含铝污染水平高于氯化钙,导致接受传统PN的患者铝中毒的可能性增加。评估了30种含无机钙盐的全肠外混合液的物理化学稳定性。

方法

在单腔乙烯-醋酸乙烯酯袋中制备肠外混合液:将氨基酸、葡萄糖、仅含无机钙盐的电解质和20%(w/w)脂质乳剂(SMOFlipid®、Omegaven®或Lipofundin MCT/LCT®)一起置于单腔袋中。混合液在制备后于+4°C储存长达8天。进行了外观观察、液滴大小分布(使用光学显微镜、激光衍射和光子相关光谱法)、pH分析和ζ电位测量。

结果

证实了29种含无机钙盐的肠外混合液的物理化学稳定性。一种混合液因油滴聚结而被认为不适合临床使用。

结论

尽管存在无机钙盐,儿科肠外混合液在储存长达8天内仍保持稳定。由于存在多种成分且不相容风险高,在临床实践中使用前应对每种混合液进行物理化学研究。

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