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肠外营养溶液中的微粒污染:仍然值得关注吗?

Particulate contamination in parenteral nutrition solutions: still a cause for concern?

作者信息

Ball P A, Bethune K, Fox J, Ledger R, Barnett M

机构信息

School of Pharmacy, University of Otago, Dunedin, New Zealand.

出版信息

Nutrition. 2001 Nov-Dec;17(11-12):926-9. doi: 10.1016/s0899-9007(01)00708-0.

Abstract

OBJECTIVES

In consideration of a US Federal Drug Administration recommendation that all parenteral nutrition admixtures should be administered through an in-line filtration device, this observational study examined the number, size distribution, and sources of particulate contamination in parenteral nutrition admixture infusion systems.

METHODS

Samples were drawn from the terminal connection of the infusion tubing before connection to the patient. The particles were sized and counted by optical microscopy and further investigated by electron microscopy and energy disperse spectroscopy.

RESULTS

Large numbers of particles were found, and information gained about their possible origin.

CONCLUSIONS

This study provides further support for the adoption of this Federal Drug Administration recommendation.

摘要

目的

鉴于美国食品药品监督管理局建议所有肠外营养混合液均应通过在线过滤装置给药,本观察性研究检测了肠外营养混合液输注系统中颗粒污染物的数量、大小分布及来源。

方法

在输液管与患者连接前,从输液管的终端连接处采集样本。通过光学显微镜对颗粒进行大小测量和计数,并通过电子显微镜和能谱分析进一步研究。

结果

发现了大量颗粒,并获取了有关其可能来源的信息。

结论

本研究为采纳美国食品药品监督管理局的这一建议提供了进一步支持。

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