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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。
Objective To develop a double-layered membrane preparation suitable for treating oral ulcer. Methods By pre-experiment and orthogonal experiment, the prescriptions of blank separator and drug layer film were screened out, and the double-layer filming agent was prepared by homogenization casting film-forming method and the related indexes were determined. RESULTS: 2.5% ethylcellulose ethanol solution was used as a blanket membrane-forming solution and 1% chitosan, 2% gelatin and pH6.5 aqueous solution were used as the double-layer membrane-forming solution. Good, blank space without bioadhesive, insoluble in saliva, to protect the drug layer of drugs from the saliva, so that unilateral drug release, the determination of other relevant indicators of membrane results in line with clinical needs. Conclusion The bilayer membrane preparation developed in this experiment is reasonable in structure and of good quality. It is suitable for the local treatment of oral ulcer.