口腔溃疡双层膜的研制及质量控制

Preparation of one-way sustained-release bistratal drug-film for oral ulcer and its quality control

目的通过口腔溃疡双层膜的制备工艺设计和研究,建立口腔溃疡双层膜的制备及质量控制的方法。方法以盐酸地卡因、硫酸新霉素、倍他米松为主药,以聚乙烯醇、羧甲基纤维素钠按适当比例为基质制成一定厚度的膜剂,采用紫外分光光度法在310 nm波长处对盐酸地卡因含量进行测定来控制质量。结果制成的膜剂塑性、色泽良好,以紫外扫描地卡因在310 nm处有明显的吸收峰,且无干扰,线性关系良好r=0.999 3,平均回收率为99.8%,RSD=0.95%。结论该制剂符合膜剂项下的有关规定,紫外分光光度法测口腔溃疡双层膜中地卡因含量简便、快速、准确;可作为医院制剂的质量控制方法。

Objective This article describes the preparation of one-way sustained-release bistratal drug-film for oral ulcer and its quality control. Methods Using tetracain hydrochloride , neomycin sulfate and betamethasone as therapeutic drug, PVA17-88 and sodium carboxymethycellulose base to prepare one-way sustained-release bistratal drug-film for oral ulcer. The product was controlled by UV spectrophotometry . Results The product is good at color and plasticity. UV spectrophotometry showed that tetracain hydrochloride absorbance peak was at 310 nm. The method was linear and reproducible. The average rate of recovery was 99. 8% , RSD was 0. 19%. Conclusion The product conforms to drug-film preparation standard. UV spectrophotometry was reliable, simple and accurate. It can be used as the quality control of one-way sustained-release bistratal drug-film for oral ulcer.