肾石通丸质量标准的研究

Study on Quality Standard for Shenshitong Pills

目的:研究肾石通丸的质量标准。方法:薄层鉴别木香、鸡内金、金钱草;RP-HPLC法测定丹参中丹酚酸B的含量。含量测定采用Waters C18色谱柱(4.6 mm×200 mm,5μm),流动相为甲醇-乙腈-甲酸-水(30∶10∶1∶59),流量1 mL.min-1,检测波长286 nm。结果:薄层鉴别阴性对照均无干扰;含量测定丹酚酸B在0.054 67～2.186 69μg范围内有良好的线性关系(r=0.999 9),平均加样回收率为99.0%(n=6)。结论:所建方法简单、可靠,可用于肾石通丸的质量控制。

Objective： To establish a method for the quality standard of Shenshitong Pills. Methods： The TLC methods were established for Aucklandiae Radix ,Galli Gigerii Endothelium Corneum, Lysimachiae Herba and an RP-HPLC methed was established for the deter mination of salvianolic acid B in Shenshitong Pills. Waters Cis （4.6 mm× 200 mm ,5 μm） colmnn was used and methanol-acetonitrile-methanoic acid-water （30： 10： 1： 59） was as the mobile phase at flow rate of 1.0 mL . min^-1. The detection wavelength was 286 nm. Results：TCL results displayed that negative control was non-interference. The linear range of salvianolic acid B was 0. 054 67- 2. 186 69 ~g（ r = 0. 999 9） , the main recovery （n = 6）was 99. 0%. Conclusion： The method is convenient, reliable and suitable for quality assessment of Shengshitong Pills .