结晶化作为一种改善药物稳定性和疗效的有效途径而广泛应用于制药领域,但蛋白质晶体由于复杂的结晶行为限制了其在药物传递系统中的广泛应用。随着蛋白质结晶技术的不断发展及其工业化应用,蛋白质晶体作为一种新型的生物大分子给药系统日益受到关注。热力学稳定的晶体结构可提高蛋白质类药物的理化稳定性,并具有缓释性能。本文根据近年文献报道,介绍了蛋白质晶体作为药物传递系统的研究现状和进展,并系统阐述了蛋白质结晶的基本过程、制备方法及应用特点。
Crystallization has been widely applied in pharmaceutical formulations as an effective approach to improve the stability and efficacy of small agents. However protein crystals are suffered from limitation in the drug delivery system due to their complex crystallization behaviors. With development of crystallization technologies and their industrial application, protein crystals are receiving more and more attentions as a novel delivery system for biomacromolecules. Crystals with thermodynamic stable structure can improve the physical and chemical stability of protein drugs and present a sustained release behavior. On the basis of pertinent literatures, this review introduces the recent research situation and development process of protein crystals as drug delivery system. Moreover, the crystallization process of proteins, as well as the preparation and potential application are discussed systematically.