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用于配方设计的水包油乳液的系统表征

Systematic characterization of oil-in-water emulsions for formulation design.

作者信息

Roland I, Piel G, Delattre L, Evrard B

机构信息

Laboratoire de Technologie Pharmaceutique, Département de Pharmacie, Université de Liège, Bât. B36, Tour 4, Avenue de l'Hôpital, 1, Liège B 4000, Belgium.

出版信息

Int J Pharm. 2003 Sep 16;263(1-2):85-94. doi: 10.1016/s0378-5173(03)00364-8.

Abstract

Oil-in-water emulsions varying in surfactant concentration and manufacturing process were prepared. About 10 experiments were performed to characterize them. The goal of this research was to find out which tests should systematically be carried out to assess efficiently the stability and the properties of an emulsified preparation. Thus, formulation design requires at least the measurement of the droplet size, the determination of the zeta potential, a TurbiScan analysis, the investigation of the stability under centrifugation and freeze/thaw cycles. If the emulsion contains an active substance, stability under storage at 4 degrees C and microscopic analysis are relevant. Quality control should be improved by measurements of viscosity and pH.

摘要

制备了表面活性剂浓度和制造工艺不同的水包油乳液。进行了约10次实验对其进行表征。本研究的目的是找出哪些测试应系统地进行,以有效评估乳化制剂的稳定性和性质。因此,配方设计至少需要测量液滴大小、测定ζ电位、进行TurbiScan分析、研究离心和冻融循环下的稳定性。如果乳液含有活性物质,则4℃储存下的稳定性和显微镜分析也很重要。应通过测量粘度和pH值来改进质量控制。

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