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用于胃肠外营养的脂质乳剂中植物甾醇的测定

Phytosterol determination in lipid emulsions for parenteral nutrition.

作者信息

Llop Talaverón Josep M, Novak Ana, Suñé Negre Josep M, Badia Tahull María, Leiva Badosa Elisabet, Ticó Grau Josep R

机构信息

Servicio de Farmacia, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat Grupo de Farmacoterapia, Farmacogenética y Tecnología Farmacéutica, Instituto de Investigación Biomédica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat Departamento de Farmacia y Tecnología Farmacéutica, y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona.

Departamento de Farmacia y Tecnología Farmacéutica, y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona.

出版信息

Farm Hosp. 2018 May 1;42(3):116-119. doi: 10.7399/fh.10954.

Abstract

OBJECTIVE

The presence of phytosterols in vegetal lipid emulsions has been  associated with alterations of liver function tests. Determination of phytosterols  content, currently undeclared, would allow the development of strategies to  prevent or treat these alterations.

METHOD

3-4 non-consecutive batches of 6 lipid emulsions from different providers (Clinoleic, Intralipid, Lipofundina, Lipoplus, Omegaven and Smoflipid) were analyzed. Differences in total phytosterol assay between providers and batches were statistically studied by a one-way ANOVA and Kruskal-Wallis non-parametric approximation and post hoc Scheffé test (p < 0.05)Results: The absence of phytosterols was confirmed in Omegaven, emulsion  based on fish oil. The highest assay of phytosterols (422.4 ± 130.5 μg/mL) has  been related with the highest percentage of soya bean oil in Intralipid. In the  remaining emulsions, concentrations were from 120 to 210 μg/mL related to the  percentage of soya bean oil. Statistically significant differences of phytosterol  content in lipid emulsions were observed among different providers (F = 23.59;  p = 0.000) as well as among non-consecutive batches. Clinolenic (F = 23.59; p  = 0.000), Intralipid (F = 978.25; p = 0.000), Lipofundina TCL/TCM (F = 5.43; p  = 0.045), Lipoplus (F = 123.53; p = 0.000) and Smoflipid (16.78; p = 0.000).  Except for Lipofundina TCL/TCM, the differences between batches were marked.

CONCLUSIONS

Lipid emulsions, registered on Spanish pharmaceutical market,  contain variable quantities of phytosterols dependent on commercial brand and  batch.

摘要

目的

植物性脂质乳剂中植物甾醇的存在与肝功能检查结果的改变有关。测定目前未标明的植物甾醇含量,将有助于制定预防或治疗这些改变的策略。

方法

分析了来自不同供应商(Clinoleic、Intralipid、Lipofundina、Lipoplus、Omegaven和Smoflipid)的3 - 4个非连续批次的6种脂质乳剂。通过单因素方差分析、Kruskal - Wallis非参数近似法和事后Scheffé检验(p < 0.05)对供应商和批次之间总植物甾醇含量的差异进行统计学研究。

结果

基于鱼油的乳剂Omegaven中未检测到植物甾醇。植物甾醇含量最高(422.4 ± 130.5 μg/mL)与Intralipid中大豆油的最高比例有关。在其余乳剂中,浓度与大豆油的比例相关,范围为120至210 μg/mL。不同供应商(F = 23.59;p = 0.000)以及非连续批次之间的脂质乳剂中植物甾醇含量存在统计学显著差异。Clinolenic(F = 23.59;p = 0.000)、Intralipid(F = 978.25;p = 0.000)、Lipofundina TCL/TCM(F = 5.43;p = 0.045)、Lipoplus(F = 123.53;p = 0.000)和Smoflipid(16.78;p = 0.000)。除Lipofundina TCL/TCM外,批次之间的差异明显。

结论

在西班牙药品市场上注册的脂质乳剂含有数量不等的植物甾醇,这取决于商业品牌和批次。

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