口服制剂口感评价方法的应用进展

口感是影响口服制剂成药性和患者用药依从性的重要因素,是口服制剂处方设计和临床应用的重要考量指标,如何客观、准确、简便、高效地表征口感,是制约口服制剂口感设计与开发利用的瓶颈问题。目前,国内外常用的口服制剂口感评价方法有口尝法、电子舌法、动物味觉喜好实验、体外溶出度实验和电生理实验。口尝法是口感评价的首选,但结果的客观性和重复性较差。鉴于此,其他4种口感评价技术已作为辅助方法应用于制药行业,但都存在一定的局限性。该研究重点对上述方法的检测原理、适用性及优缺点进行评述,以期为现阶段口服制剂的矫味和口感评价研究提供方法学借鉴,提高患者服药依从性和口服制剂产品的业内竞争力,推动口服制剂工艺研究水平的进步。

Application progress on taste evaluation methods for oral preparations

Taste is an important factor affecting the medicinal properties of oral preparations and patient compliance with medication,and also an important evaluation index for oral preparation design and clinical application.How to characterize the taste objectively,accurately,simply,and efficiently is a bottleneck problem that restricts the taste design,development,and utilization of oral preparations.At present,the commonly used taste assessment methods for oral preparations are traditional human taste panel,electronic tongue,animal preference test,in vitro release study,and electrophysiological test.The traditional human taste panel is the first choice for taste evaluation,but it is limited by poor subjectivity and reproducibility.Therefore,despite some limitations,the other four taste assessment methods have been applied in the pharmaceutical industry as auxiliary methods.This study reviewed the detection principles,applicability,advantages,and disadvantages of the above methods to provide references for the taste correction research and taste assessment of oral preparations,improve patient compliance and the competitiveness of oral preparation products in the industry,and promote the development of oral preparation technologies.