复方芦荟凝胶的制备及质量控制方法研究

来源 :2012转化医学与中药现代化高峰论坛 | 被引量 : 0次 | 上传用户:hobbysh
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  目的:制备复方芦荟凝胶并建立其质量控制方法.方法:以复方芦荟凝胶的外观、肤感、pH值及离心、耐热、耐寒试验为指标,对凝胶的基质、增溶剂、保湿剂、防腐剂进行筛选,并对其用量进行考察.高效液相色谱法测定凝胶中绿原酸、芍药苷、迷迭香酸的含量,乙腈—0.1%磷酸溶液进行梯度洗脱,流速:1.0 mL·min-1;柱温:40℃;检测波长:绿原酸、迷迭香酸327 nm、芍药苷230 nm;进样量:10μL.以甘露糖标准液绘制标准曲线,(蒽)酮-硫酸法测定芦荟多糖含量,检测波长610 nm.结果:最佳处方为:壳聚糖2.5%,增溶剂RH40 3%,冰醋酸1%,甘油6%,苯扎溴铵0.1%,药液40%,蒸馏水47.1%.所制备的凝胶外观均匀细腻,肤感滋润、易涂抹与清洗.绿原酸、芍药苷、迷迭香酸、芦荟多糖检测浓度线性范围分别为87.50~437.5 μg·mL-1 (r=0.9999)、34.50~345.0μg·mL-1(r=0.9997)、4.0~80 μg·mL-1(r=0.9996)、10.0~90.0μg·9mL-1 (r=0.9998).平均回收率分别为:97.3%、97.6%、92、8%、98.8%,RSD分别为:1.7%、1.2%、3.6%、2.0%.结论:该制剂处方设计合理,制备方法简单,质量稳定可控.
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