复方丹参口溶膜剂制备工艺研究

Preparation of Fufang Danshen oral dissolvable films(ODF)

目的制备具有良好性质的复方丹参口溶膜。方法以复方丹参口溶膜的成膜时间、外观性状、韧度和厚度、溶解时间为指标,通过正交试验进行处方优化,考察PVA17-88、CMC-Na及甘油的用量。结果正交试验结果表明,以15%PVA17-88、2%CMC-Na、15%甘油为处方的复方丹参口溶膜剂具有良好的性质。结论该方法制备复方丹参口溶膜具有良好性质。

Objective To prepare the Fufang Danshen Oral Dissolvable Films(ODF)with good properties.Methods The Danshen ODF formation time,film appearance,flexibility and thickness,film dissolution time were selected as indexes,the amount of PVA17-88,CMC-Na and GL were explored as factors.Screening Film forming material and optimize the formulation through the orthogonal test.Results The optimal formulation of compound Danshen ODF is 15%PVA17-88,2%CMC-Na,15%GL.Conclusion The Compound Danshen ODF made of optimal formulation of 15%PVA17-88,2%CMC-Na,15%GL showed high quality.