复方紫草烧烫伤涂膜剂的制备及质量控制

Preparation and Quality Control of Compound Radix Arnebiae Empyrosis Films

目的：制备复方紫草烧烫伤涂膜剂并建立其质量控制方法。方法：以紫外法测定涂膜剂中紫草素的含量，同时利用理化鉴定、薄层色谱对涂膜剂进行质量控制。结果：薄层色谱斑点清晰，阴性无干扰；含量测定测得左旋紫草素浓度在9．6～28．8μg·ml-1范围内与吸光度呈良好的线性关系（r=0．9995），平均回收率为100．05％，RSD=2．56％（n=6）。结论：该涂膜剂制备工艺稳定可靠，建立的质量控制方法简便准确，重复性好：’

Objective： To prepare compound Radix arnebiae empyrosis films and establish the quality control methods. Methods： Shikonin in the films was determined by UV method, and physicochemical identification and TLC were used to control the quality of the films. Results： The TLC spots were clear and well-separated without negative interference. The concentration of L-shikonin had a good linear relationship with the absorbance within the range of 9.6-28.8 μg · ml-1 （ r =0.999 5 ）. The average recovery was 100.05% with RSD of 2.56% （ n = 6）. Conclusion： The preparation conditions are stable and reliable, the established quality control method is simple, feasible and reproducible.