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含双氯芬酸钠的水包油型乳剂型软膏的物理药学特性

Physicopharmaceutical characteristics of an oil-in-water emulsion-type ointment containing diclofenac sodium.

作者信息

Takamura A, Ishii F, Noro S, Koishi M

出版信息

J Pharm Sci. 1984 May;73(5):676-81. doi: 10.1002/jps.2600730521.

Abstract

The oil-in-water (o/w) emulsion-type ointment was prepared with food additives containing diclofenac sodium. The oil phase and the emulsifier used were 1,2,3- propanetriyl trioctanoate (caprylic acid glyceryl ester) and sugar wax, and sugar ester, respectively. The emulsion stability of the o/w emulsion-type ointment as well as the diclofenac sodium release profile were investigated and compared with those from conventional ointments. The emulsion stability was evaluated in terms of the viscosity of the emulsion product, the particle size distribution of oil droplets, and the zeta potential of the droplets. It was found that sugar esters have excellent properties as emulsifiers, based on the results of viscosity and zeta potential measurements. The in vitro release test revealed that the amount of diclofenac sodium released from o/w emulsion-type ointment was greater than from the hydrophilic and absorptive ointment. Accordingly, it was concluded that o/w emulsion-type bases are suitable for pharmaceutical use in ointment products.

摘要

采用含有双氯芬酸钠的食品添加剂制备水包油(o/w)乳液型软膏。所用的油相和乳化剂分别为三辛酸甘油酯(辛酸甘油酯)和糖蜡以及糖酯。研究了o/w乳液型软膏的乳液稳定性以及双氯芬酸钠的释放曲线,并与传统软膏进行了比较。通过乳液产品的粘度、油滴的粒径分布和液滴的ζ电位来评估乳液稳定性。基于粘度和ζ电位测量结果发现,糖酯作为乳化剂具有优异的性能。体外释放试验表明,o/w乳液型软膏中双氯芬酸钠的释放量大于亲水性和吸收性软膏。因此,得出结论:o/w乳液型基质适用于软膏产品的药物应用。

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