紫白膏质量标准的研究

Study on Quality Standard of Zibai Ointment

目的建立紫白膏的质量标准。方法采用薄层色谱法(TLC)对紫草进行定性鉴别;采用高效液相色谱法(HPLC)对膏剂中左旋紫草素进行含量测定,色谱柱为Sepax Gp-C18柱(4.6mm×150mm,5μm),流动相为乙腈-0.2%磷酸(95∶5),流速为1.0m L·min-1,检测波长为516 nm,柱温40℃。结果 TLC鉴别紫草具有良好的分离效果,易于区别;左旋紫草素在0.1016~1.6256μg的质量范围内与峰面积具有良好线性关系,r=0.9999,平均回收率为97.46%(RSD=1.20%,n=6)。结论所建立的鉴别方法简便、专属性强;定量方法准确、灵敏度高,可用于紫白膏的质量控制。

OBJECTIVE To establish the quality standard of Zibai ointment. METHODS TLC was used for i- dentification of Arnebiae Radix;HPLC was applied for the content determination of L-shikonin in the ointment. The column was Sepax Gp-C18 column （4. 6mm× 150mm,5μm）, the mobile phase consisted of acetonitrile-0. 2% phosphoric acid （95：5） , the flow rate was 1.0mL ·min-1, detection wavelength was 516nm, column temperature was 40℃. RESULTS TLC had a good separation effect for the identification of L-shikonin and it was easy to distinguish. The linear range of L-shikonin was 0. 1016 - 1. 6256μg （ r = 0. 9999 ） and its average recovery rate was 97.46% （RSD = 1.20%, n = 6）. CONCLUSION The identification method is simple, specific and the quantitative method is accurate and sensitive. The standard established can be used for quality control of Zibai ointment.