FAT EMULSIONS FOR PARENTERAL-NUTRITION .2. CHARACTERIZATION AND PHYSICAL LONG-TERM STABILITY OF LIPOFUNDIN MCT/LCT

被引：24

作者：

MULLER, RH

HEINEMANN, S

机构：

[1] Department of Pharmaceutics and Biopharmaceutics, University of Kiel, D-24118 Kiel

来源：

CLINICAL NUTRITION | 1993年 / 12卷 / 05期

关键词：

D O I：

10.1016/0261-5614(93)90050-E

中图分类号：

R15 [营养卫生、食品卫生]; TS201 [基础科学];

学科分类号：

100403 ;

摘要：

Lipofundin MCT/LCT* emulsions for parenteral nutrition were characterized in terms of particle size (bulk population), presence of large particles (>> 1 mum) and drop et charge (zeta potential as measure of electrostatic stabilization). Photon Correlation Spectroscopy (PCS), microscopy and Laser Diffractometry (LD) were employed as sizing techniques and compared to each other. Zeta potentials were determined by Laser Doppler Anemometry (LDA). The characterization data showed a good batch-to-batch reproducibility. The physical stability of Lipofundin MCT/LCT-was monitored over a period of 2 years. The mean diameter of the bulk droplet population did not increase. No formation of larger droplets was found by microscopy and LD. A negligible coalescence could only be detected by the very sensitive PCS measurements (two time window analysis). The zeta potential stayed above -45 mV providing sufficient electrostatic stabilization during the whole storage period.

引用

页码：298 / 309

页数：12

共 37 条

[1]

Ney, Zetapotentiale und Flotierbarkeit von Mineralien, (1973)

[2]

Karino, Hayashi, Yamada, Ozawa, Effect of particle size and emulsifiers on the blood clearance and deposition of injected emulsions, J Pharm Sci, 76, (1987)

[3]

Wilkins, Myers, Studies on the relationship between the electrophoretic properties of colloids and their blood clearance and organ distribution in the rat, Brit J Exp Path, 47, pp. 568-576, (1966)

[4]

Davis, Illum, West, Galloway, Studies on the fate of fat emulsions following intravenous administration to rabbits and the effect of added electrolyte, Clin Nutr, 6, pp. 13-19, (1987)

[5]

Schroeder, Bivins, Sherman, DeLuca, Physiological effects of subvisible microspheres administered intravenously to beagle dogs, J Pharm Sci, 67, pp. 508-513, (1978)

[6]

Slack, Kanke, Simmons, DeLuca, Acute hemodynamic effects and blood pool kinetics of polystyrene microspheres following intravenous administration, J Pharm Sci, 70, pp. 660-664, (1981)

[7]

Thompson, Jones, Ferrell, Et al., Testing of fat emulsions for toxicity, III. Toxicity studies with new fat emulsions and emulsion components, Am J of Clin Nutr, 16, pp. 43-61, (1965)

[8]

Davis, Hadgraft, Palin, Medical and Pharmaceutical Applications of Emulsions, Encyclopedia of Emulsion Technology, 2, pp. 159-237, (1985)

[9]

Fujita, Sumaya, Yokoyama, Fluorocarbon emulsion as a candidate for artificial blood, Eur Surg Res, 3, pp. 436-453, (1971)

[10]

Ondracek, Boller, Zullinger, Niederer, Vergleich zwischen fünf Methoden zur Prüfung der physikalischen Stabilität von O/W-Emulsionen, Acta Pharm Technol, 31, pp. 42-48, (1985)

← 1 2 3 4 →