溶剂浇铸法制备乙酰天麻素口溶膜及其质量分析

Preparation and Quality Analysis of Acetagastrodin Oral Fast Dissolving Films by Solvent Casting Method

本研究以羟丙甲纤维素和聚乙烯醇为主要膜材,以羧甲淀粉钠为崩解剂,采用溶剂浇铸法制备乙酰天麻素口腔速溶膜。以耐折度、崩解时间和体外溶出度的综合评分为指标,通过单因素和正交实验筛选和优化乙酰天麻素口溶膜的处方组成,以制备崩解迅速、便于携带和用药顺应性好的口溶膜。结果表明,所制备的口溶膜形态良好,质量均一稳定,崩解时间均小于32 s,溶出度在10 min时可达到85%以上,释药性能优于乙酰天麻素片。相比较其他剂型患者依从性更好,具有明显的临床优势,为乙酰天麻素口溶膜后续开发研究提供了科学依据。

In this study,acetagastrodin oral fast dissolving film was prepared by solvent casting method with hypromellose and polyvinyl alcohol as the main membrane materials and carboxymethyl starch sodium as disintegrating agent.Taking the comprehensive scores of folding endurance,disintegration time and in vitro dissolution as indicators,the formulation of acetagastrodin oral fast dissolving film was screened and optimized by single factor and orthogonal experiments to prepare oral fast dissolving film with rapid disintegration,portability and good medication compliance.The results showed that the prepared oral fast dissolving film had good morphology,uniform and stable quality,the disintegration time was less than 32 s,and the dissolution could reach more than 85%in 10 min,and the drug release performance was better than that of acetagastrodin tablets.Compared with other dosage forms,patients'compliance is better,which has obvious clinical advantages,and provides a scientific basis for the follow-up development of acetagastrodin oral fast dissolving film.