膜剂的研究和应用进展

Research and Application Progress of Pharmaceutical Films

膜剂系指药物与适宜的成膜材料经加工制成的膜状制剂。国内最早于1970年代开始研制避孕药膜,膜剂品种于1985年被中国药典收录。膜剂相比传统制剂具有独特的临床优势,给药方便,患者顺应性高,可提高药物的生物利用度,而且采用适宜的成膜材料可以延缓药物的释放,减少给药频率。本文概述了膜剂的处方和生产工艺,综述了口腔膜剂、眼用膜、阴道膜和牙周膜等膜剂的特点、研究和应用现状及其质量评价方法。

The pharmaceutical films are single- or multi-layer sheets with a size of postage stamp, which can be referred as a drug release platform used for both local and system action via oral, buccal, sublingual, ocular, vaginal and dental routes. The study of films in China can be traced back to 1970s, while the contraceptive films for vaginal administration were developed by China State Institute of Pharmaceutical Industry. And the current Chinese Pharmacopoeia on this dosage form was updated on the 1985 edition. Compared with the traditional dosage forms, the pharmaceutical film can be considered as a versatile drug delivery system with several clinical advantages, including convenient administration, high patient compliance and enhanced bioavailability. Furthermore, a prolonged drug release and lowered administration frequency can be achieved by using suitable polymers. This paper focuses on the research and application progress of pharmaceutical films, and aims to provide an overview of their formulation, production progress, particular features, and quality evaluation methods.