双层口腔溃疡膜的制备工艺及释放度研究

目的 制备中药黄柏提取物双层口腔溃疡膜,并考察其体外释放情况.方法 采用流延法制备双层膜,以海藻酸钠浓度(A)、海藻酸钠/氯化钙比例(B)、壳聚糖用量(C)为因素进行正交试验优选保护层处方,采用HPLC法测定盐酸小檗碱含量,并计算体外释放度.结果 所制膜性状良好,保护层处方确定A为2.0%,B为1∶2,C为10mL.盐酸小檗碱浓度线性范围为0.2~2.2μg·mL-1,平均回收率为100.41%,RSD值为0.85%.双层膜可持续释药6h,3h体外累积释放度83.42%.双层膜可持续释药6h,3h体外累积释放度83.42%.结论 所制膜剂设计合理,工艺简单可行,具有一定应用价值.

Preparation Technology and Release Rate of Oral Ulcer Double-layer Membranes

OBJECTIVE To prepare double-layer phellodendron oral ulcer membranes,and investigate its release rate in vitrol.METHODS The membranes were prepared using tape-casting technology,the formula of protecti ve layer were optimized by orthogonal experiment with the consistency of sodium alginate(A),the consistency ratio of sodium alginate to calcium chloride(B) and the amount of chitosan(C) as factors.HPLC was used to measure the contents of berberine and its release rate was also computed.RESULTS The m embranes were well shaped and the optimized formula was as follows:A=2.0%,B=1∶2,C=10mL.The linear ranges of berberine were 0.2~2.2μg·mL-1 with an average recovery of 100.41%,RSD 0.85%.A continuous releasing of 6 hours w as achieved for the membranes and its cumulative release amount within 3 hours r eached 83.42%.CONCLUSION The design of double-layer membrane is reasonable,simple and applicable,the membrane has an application value.