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目的:制备新疆紫草提取物凝胶剂并考察其初步的质量。方法:采用正交试验设计,以卡波姆-940、丙二醇的用量及pH为考察因素,以凝胶剂的光泽度、涂展性、均匀度、离心性为指标进行综合评分,筛选优化处方,制备新疆紫草凝胶剂。采用紫外分光光度法测定左旋紫草素的含量。结果:优化处方为卡波姆-940 0.7%,丙二醇10%,pH 6.5,左旋紫草素在5～30mg.L-1与吸收度呈良好的线性关系,相关系数为0.999 9。平均加样回收率为95.7%(RSD 3.06%,n=6)。体外释药曲线符合Higuchi方程。结论:该凝胶剂制备工艺简单,质量可控,各项指标符合凝胶剂的质量标准。
Objective: To prepare Xinjiang Lithospermum extract gel and investigate its preliminary quality. Methods: Using orthogonal experimental design, taking carbomer-940, the amount of propylene glycol and pH as the investigation factors, the gloss, spreadability, evenness and eccentricity of gel were scored as indexes to screen the optimal prescription Preparation of Lithospermum Xinjiang gel. Determination of L-shikonin by UV spectrophotometry. Results: The optimal prescriptions were carbomer-940 0.7%, propylene glycol 10%, pH 6.5, levosulfithin at 5 ~ 30 mg.L-1 and absorption showed a good linear relationship with a correlation coefficient of 0.999 9. The average recovery was 95.7% (RSD 3.06%, n = 6). In vitro release curve in line with Higuchi equation. Conclusion: The gel preparation process is simple, quality control, the indicators meet the quality standards of the gel.