口腔膜剂的研发与评价

口腔膜剂(oral films)为一种新型的口服制剂,轻便、工艺简单、顺应性好等特点使其近年来受到关注和重视,近年来口腔膜剂也逐步应用于中药制剂的开发。该文结合近年来国内外口腔膜剂的申报和批准情况,从基本概念、处方工艺和质量控制等方面对口腔膜剂的研发现状进行分析,关注了口腔膜剂在中药制剂中的研究进展和开发前景。结合药品监管法规的具体要求,对相关技术评价的关注点提出建议,为口腔速溶膜剂的开发和评价提供若干参考。中药成分的复杂性和中药制剂的特殊性,对口腔膜剂在中药制剂中的开发和申报提出了新的机遇和挑战。

Research & development and evaluation of oral films

Oral film is a new type of oral preparation. Due to portability, simple preparation process and good clinical compliance, oral films have become the focus of novel drug delivery system in recent years. Meanwhile, oral films have been gradually used in the development of Chinese medicine preparations. According to the application and approval situation of different types of oral films both at home and abroad in recent years, their research and development status was analyzed, including the basic concept, formulation, manufacturing process and quality control, as well as related progress and development prospects of oral films applied in traditional Chinese medicine. Some suggestions on the technical evaluation of oral films were put forward by considering specific requirements from regulatory agencies. This paper could provide some references for the development and evaluation of oral films. Due to the complexity of the drug substances and the particularity of the drug product, the development and application of oral films in traditional Chinese medicine are still faced with opportunity and challenges.