口腔膜剂研发与评价.doc

口腔膜剂研发与评价 　　[摘要] 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。 　　[关键词] 口腔膜剂； 产品开发； 评价 　　[Abstract] 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. 　　[Key words] oral film； research and development； evaluation 　　口服制?└?药方便，生产成本低，是大多数人的首选用药途径，其中固体口服制剂主要以片剂和胶囊为主。然而吞咽困难等问题是导致患者依从性差的主要原因[1]。尤其儿童在服用固体制剂时，吞咽困难可能会产生吐药现象或窒息危险[2]，随着儿童用药在国内关注度的提高，解决儿童不愿吞咽、依从性差等问题也成为制剂开发的重点[3]。此外，一些自主行为不受控制的精神系统障碍的患者，同样存在传统口服制剂给药困难大、服用风险高的情况。为了解决这些问题，最初开发了口腔崩解片（oral disintegrating tablets，ODTs），其在口腔内能快速溶化和崩解。但是大部分口腔崩解片存在易碎、抗折性差等缺点，对于包装、储存和运输都具有相对严苛的要求。故在此基础上进行剂型改良，进一步开发了口腔膜剂[4-5]。由于具备易于携带、口腔中迅速溶解等优点，口腔膜剂得到了快速发展，国内外已有多种口腔膜剂的上市产品。本文从处方工艺、质量控制等多方面对口腔膜剂的研发现状进行分析，并对相关技术评价的关注点提出建议。 　　1 口腔膜剂的基本概况 　　1.1 名称及分类 　　《中国药典》1985年版即开始收载了膜剂各论，1990年版新