消栓再造丸质量标准提升研究

Improvement of Quality Standard of Xiaoshuan Zaizao Pills

目的提升消栓再造丸的质量标准。方法采用薄层色谱(TLC)法对制剂中的黄芪、天麻进行定性鉴别;采用高效液相色谱法测定制剂中血竭素的含量,色谱柱为Phenomenex C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.05 mol/L磷酸二氢钠溶液(50∶50,V/V),流速为1.0 mL/min,检测波长为440 nm,柱温为40℃,进样量为10μL。结果黄芪、天麻的TLC图斑点清晰,分离度好,阴性对照无干扰。血竭素质量浓度在1.4289~178.6131μg/mL范围内与峰面积线性关系良好(r=0.9999);精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率为97.33%,RSD为2.92%(n=9)。结论所建标准准确、简便、重复性好,可用于完善消栓再造丸的质量标准。

Objective To improve the quality standard of Xiaoshuan Zaizao Pills.Methods Astragali Radix and Gastrodiae Rhizoma in the preparation were identified by the thin-layer chromatography(TLC).The content of dracorhodin in the preparation was determined by the high-performance liquid chromatography(HPLC),the chromatographic column was Phenomenex C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.05 mol/L sodium dihydrogen phosphate solution(50∶50,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 440 nm,the column temperature was 40℃,and the injection volume was 10μL.Results The TLC spots of Astragali Radix and Gastrodiae Rhizoma were clear and well separated,and the negative control had no interference.The linear range of dracorhodin was 1.4289-178.6131μg/mL(r=0.9999),the RSDs of precision,stability and repeatability tests were all less than 3.0%.The average recovery of draconin was 97.33%with an RSD of 2.92%(n=9).Conclusion The established standard is accurate,simple and reproducible,which can be used for the improvement of the quality standard of Xiaoshuan Zaizao Pills.