肾石通颗粒质量标准的研究

Study on Quality Standard for Shenshitong Granules

目的:研究肾石通颗的质量标准。方法:增加TLC法鉴别木香、牛膝、丹参、延胡索及RP-HPLC法测定丹酚酸B的含量。含量采用Waters C18色谱柱(4.6mm×200mm,5μm);流动相为甲醇-乙腈-甲酸-水(30∶10∶1∶59),流速1mL·min-1,检测波长286nm。结果:鉴别:阴性对照均无干扰;含量:0.053165～1.0633μg范围内有良好的线性关系(r=0.9999),平均加样回收率为100.5%(n=6)。结论:所建方法简单、可靠,可用于肾石通颗的质量控制。

Objective ： To establish a method for the quality standard of Shenshitong Granules. Methods： The TLC methods were estab- lished for Common Aucklandia Root, Twotoothed Achyranthes Root, Danshen Root, Yanhusuo and a RP-HPLC method was established for the determination of Salvianolic acid B performed on. Waters C ls analytical column （4. 6 mm × 200 mm,5 μm） with methanol-acetonitrile-formic acid- water （30： 10： 1： 59） as the mobile phase at the flow rate of 1.0 mL . min-1. The detection wavelength was 286 nm. Results： Identification ： negative control average non-interference ; content ： The linear range was 0. 053 165 - 1. 063 3 μg （ r = 0. 999 9） and average recovery （n = 6） was 100. 5%. Conclusion：The method is convenient, reliable and suitable for quality assess- ment of Shengshitong Granules.