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近年来,药剂学领域出现许多增加水难溶性药物溶解度和吸收的技术,其中自乳化释药系统(self-emulsifying drugdelivery systems,SEDDS)得到了广泛的发展。SEDDS 是由药物、油、乳化剂及助溶剂等组成的一种油状混合物,在体外轻微振荡或体内胃肠道的蠕动下自发的形成一种热力学稳定的乳状液,其粒径大约100～300 nm,粒径小于100 nm的乳剂称为自微乳化释药系统(self-microemulsifying drugdelivery systems,SMEDDS)。与 SEDDS 相比,SMEDDS 的最大优点是粒径小、溶液澄清透明、药物增溶量大、制剂更稳定。本文就 SMEDDS 的处方组成、结构与理化性质、质量评价以及应用等方面作一简要综述。1 处方组成SEDDS 的基本处方组成包括药物、油、乳化剂及助溶剂等。SMEDDS 的基本处方组成与 SEDDS 相同,其特殊性在
In recent years, many technologies for increasing the solubility and absorption of water-insoluble drugs have emerged in the field of pharmaceutics. Self-emulsifying drug delivery systems (SEDDS) have been widely developed. SEDDS is an oily mixture composed of drugs, oils, emulsifiers and cosolvents, which forms spontaneously a thermodynamically stable emulsion with slight oscillations in vitro or by peristalsis of the gastrointestinal tract in vivo with particle sizes of about 100-300 nm and emulsions with a particle size of less than 100 nm are known as self-microemulsifying drug delivery systems (SMEDDS). Compared with SEDDS, the biggest advantage of SMEDDS is that the particle size is small, the solution is clear and transparent, the drug is solubilized and the preparation is more stable. In this paper, a brief review is made on the prescription composition, structure and physicochemical properties, quality evaluation and application of SMEDDS. 1 Prescription Composition The basic prescription of SEDDS consists of drugs, oils, emulsifiers and cosolvents. The basic prescription of SMEDDS is the same as that of SEDDS