干酏剂是一种将乙醇和药物同时包裹入水溶性聚合物壳内的固态微囊。乙醇的潜溶剂作用及喷雾干燥工艺可能产生的无定形药物,有利于包裹于干酏剂中的水难溶性药物快速分散并溶解于水性介质中,从而提高其溶出速率和生物利用度。本文综合近年来干酏剂研究的主要文献,从干酏剂的制剂成型工艺及机制、对难溶性药物体外溶出、体内吸收及生物利用度的影响,以及基于干酏剂的剂型设计及应用做一综述。
Dry elixir is a solid form of microcapsules simultaneously containing ethanol and drug in water-soluble polymer shell. The poorly water-soluble drugs encapsulated in dry elixir are rapidly dispersed and dissolved in aqueous media on account of the eosolvent effect of ethanol and rapid dissolution of amorphous drugs formed by the spray drying technique, increasing dissolution rate and bioavailability. With reference to main literature related to the dry elixir in recent years, the preparation process and principle of the dry elixir,the impact on in vitro dissolution,in vivo absorption and bioavailability of poorly watersoluble drugs, the design and application of dry elixir are reviewed in this paper.