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目的制备紫草凝胶剂,建立其质量控制方法。方法用正交实验法以卡波姆-940,甘油配比和凝胶pH值为因素,每因素三水平,以凝胶在55℃水浴中的颜色变化时间及外观性状的综合评价为指标,用L9(34)正交表进行实验,筛选出最优处方,制备紫草凝胶剂,采用紫外-可见分光光度法测定左旋紫草素的含量,用薄层色谱法进行鉴别。结果最优处方为卡波姆-940为0.7%,甘油15%,pH为6.0,凝胶制备工艺可行,其主要成分能采用薄层色谱法鉴别,其pH为5.5～6.0稳定性好,左旋紫草素的线性范围为8.2～41.0μg.mL-1,平均回收率为99.84(,RSD为3.18((n=9)。结论该凝胶剂制备工艺简单,质量可控,方法可靠,稳定性好。
Objective To prepare Lithospermum gelatum and establish its quality control method. Methods The orthogonal experiment was carried out using the factors of carbomer-940, glycerin ratio and gel pH as the factors and the three levels of each factor, taking the comprehensive evaluation of gel color change time and appearance in 55 ℃ water bath as an index, L9 (34) orthogonal test was used to screen out the optimal prescription to prepare Lithospermum Glabra. The content of L-shikonin was determined by UV-visible spectrophotometry and identified by TLC. Results The optimal prescription was 0.7% carbomer-940, 15% glycerol and pH 6.0. The gel preparation process was feasible. The main components were identified by TLC. The pH was 5.5-6. The linear range of shikonin was 8.2 ~ 41.0μg.mL-1, the average recovery was 99.84 (RSD = 3.18 (n = 9) .Conclusion The gel preparation method is simple, the quality is controllable, the method is reliable and stable Good sex.