复方维锌口腔贴膜的制备及质量控制

目的:制备复方维锌口腔贴膜,并建立其质量控制方法。方法:用聚乙烯醇为成膜材料,以维生素E、硫酸锌、醋酸地塞米松、盐酸土霉素等为主药制备膜剂;采用高效液相色谱法测定其中主药维生素E的含量。结果:所制制剂鉴别、检查等符合《中国药典》2005年版相关规定;维生素E检测量线性范围为1.0～16.0μg(r=0.9999),平均回收率为(99.28±1.15)%,RSD<0.52%。结论:复方维锌口腔贴膜处方及制备工艺合理可行,质量控制方法快速、简便,准确性好,灵敏度高。

Preparation and Quality Control of Compound Weixin Mucoadhesive Films

OBJECTIVE： To prepare Compound weixin mucoadhesive films and to establish the quality control method. METHODS： PVA was used as membrane material and vitamin E, zinc sulfate, dexamethasone acetate, terramycin hydrochloride was used as principal components to prepare films. The content of vitamin E was determined with HPLC. RESULTS： The identification and examination of preparation were in line with the standards stated in Chinese Pharmacopeia （2005 edition）. The linear range of vitamin E were 1.0～16.0 μg （r=0.999 9） with an average recovery of （99.28±1.15）% （RSD0.52%）. CONCLUSION： Formula and preparation technology of Compound weixi mucoadhesive films is feasible. Quality control method of it is rapid, simple, accurate and sensitive.