复方黑面神软膏质量标准研究

Study on Quality Standard for Compound Breynia Fruticosa Ointment

目的：提高复方黑面神软膏质量标准。方法：采用薄层色谱鉴别法对复方黑面神软膏成分中的当黑面神、苦参、蛇床子、白鲜皮、地肤子进行定性鉴别,用高效液相色谱法测定复方黑面神软膏中表儿茶素和苦参中苦参碱的含量。结果：在选定的薄层色谱条件下,色谱斑点清晰,分离效果好,无干扰;表儿茶素含量在0.008 4~0.033 6 g/L范围内呈良好的线性关系,r=1.000,测定的平均回收率为97.7%,RSD为1.4%（n=6）;苦参碱含量在0.014 7~0.058 8 g/L范围内呈良好的线性关系,r=0.999,测定的平均回收率为97.6%,RSD为1.5%（n=6）。结论：建立的定性、定量方法较简便、准确、灵敏、重现性好。

Objective ： To improve the quality standard for compound Breynia fruticosa ointment. Methods ：The Breynia fruticosa,Sophora flavescens,Fructus cnidii,Cortex dictamni and Fructus kochiae scopariae in the ointment were qualitatively identified by thin layer chromatography（TLC）,while the contents of L-Epicatechin in Breynia fruticosa and matrine in Sophora flaves cens were determined by high performance liquid chromatography（ HPLC）. Results ： Under the selected condition,the spots on TLC plates were clear without interference. The linear range of L-Epicatechin content was 0.008 4 ~ 0.033 6 g/L（r = 1.000）,while the mean recovery rate was97.7%,with a RSD of 1.4%（n = 6）. However,the linear range of matrine content was 0.014 7 --0.058 8 g/L（ r = 0.999）,while the mean recovery rate was 97.6%,with a RSD of 1.5%（ n = 6）. Conclusion ： The developed methods for qualitative and quantitative determinations were simple,accurate,sensitive and reproducible.