治疗口腔溃疡的双层膜复方制剂的研制

 目的研制剂型更适合治疗口腔溃疡的双层膜药物制剂。方法通过预实验和正交实验,筛选出空白隔离层和药物层膜剂处方,用匀浆流延成膜法制成双层膜剂并进行相关指标的测定。结果以2.5%乙基纤维素乙醇液作为空白隔离层成膜液、以1%壳聚糖、2%明胶、pH6.5的水溶液作为药物层成膜液制成的双层膜剂,外观性状良好,空白隔离层无生物黏附性,不溶于唾液,能保护药物层药物不受唾液影响,使药物单侧释放,膜其他相关指标的测定结果符合临床需要。结论本实验研制的双层膜制剂结构合理、质量可控、适合口腔溃疡的局部治疗。

Study on a Double-layer Drug Films Used as Treating Recurrent Oral Ulcer

OBJECTIVE To develop a double-layer drug films for treating recurrent oral ulcer. METHODS According to the pre-researches and orthogonal experiment,the optimal formulas of drug layer and sealing-coat layer were screened,then the double-layer drug films were prepared and the relevant parameters were measured. RESULTS The prepared double-layer drug films with 2.5% ethylcellulose ethanol solution as the sealing-coat layer solution and 1% chitosan,2% gelatin water solution (pH 6.5) as the drug layer solution showed good appearance .The drug layer obtained appropriate adherence time on mouth mucosa. The sealing-coat layer had no adherence and no dissolutionin in saliva. CONCLUSION The preparation has a reasonable structure and is suitable for treating Recurrent Oral Ulcer.