紫草解毒软膏质量标准研究

目的 建立紫草解毒软膏的质量标准. 方法 采用薄层色谱(TLC)法对其中盐酸小檗碱、紫草进行鉴别;高效液相色谱(HPLC)法测定其中左旋紫草素的含量,色谱柱为Hypersil BDS C₁₈柱(4.6 mm×250 mm,5 μm);流动相为甲醇-0.2%磷酸(25：75);流速为1.0 mL.min^-1;检测波长516 nm;柱温为30 ℃. 结果TLC鉴别盐酸小檗碱、紫草具有很好的分离效果. 左旋紫草素在4.47～143.10 μg.mL^-1浓度范围内线性关系良好,r＝0.999 9,平均回收率为97.5%(RSD＝1.42%). 结论 所建立的鉴别方法 专属性强,定量方法 简便,准确,可用于紫草解毒软膏的质量控制.

Research on the Quality Standard of Zicao Jiedu Ointment

Objective To establish a quality standard of zicao jiedu ointment.Methods Berberine hydrochloride and Radix Arnebiae were identified by thin-layer chromatography(TLC).The content of L-shikonin was determined by high performance liquid chromatogram(HPLC).The column was Hypersil BDS C18 column(4.6 mm×250 mm,5 μm).The mobile phase consisted of methanol-0.2% phosphoric acid aqueous solution(25:75).The detective wavelength was 516 nm,flow rate was 1.0 mL·min-1,and the column temperature was 30 ℃.Results TLC was a good method to separate Berberine hydrochloride and Radix Arnebiae.The calibration curve of L-shikonin was linear in the range of 4.47-143.10 μg·mL-1 with good linearity(r=0.999 9).The average recovery was 97.5%(RSD=1.42%).Conclusion The method is simple,accurate and sensitive.It can be used for quality control of zicao jiedu ointment.