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设计并研制了用于实验室处方筛选及少量样品制备的实验室用涂膜机以及中试规模的药膜涂膜干燥机。分别用上述两种装备以流延法制备伏格列波糖口溶膜剂,并进行了膜剂小试到中试的工艺研究和质量评价。结果表明,小试及中试规模得到的膜剂在45 s内全部溶解,3 min内均基本释放完全,物理性能、含量及含量均匀度等指标均满足要求。
Design and development of a laboratory coating machine used for laboratory prescription screening and a small amount of sample preparation as well as the pilot-scale membrane coating dryer. Voglibose mouth-dissolving film was prepared by the above two kinds of equipment by casting method, and the technological research and quality evaluation of small-scale film-to-medium test were carried out. The results showed that all the samples obtained in small scale and pilot scale were completely dissolved within 45 s and were almost completely released in 3 min. The physical properties, content and evenness of content reached the requirements.