补肾通络颗粒质量标准研究

Study on quality standard of Bushen-Tongluo granules

目的 建立补肾通络颗粒的质量标准。方法 利用薄层色谱法对该制剂中的骨碎补、白芍、川牛膝、川芎进行定性鉴别；利用HPLC法检测柚皮苷、芍药苷含量，色谱柱为Agilent C18色谱柱（4.6 mm×250 mm，5 μm），流动相为乙腈-0.1%磷酸，检测波长230、283 nm，柱温30 ℃，流速1.0 ml/min。结果 补肾通络颗粒中骨碎补、白芍、川牛膝、川芎的薄层色谱鉴别专属性强；柚皮苷在6.337 0～50.695 7 μg范围内线性关系良好，芍药苷在26.065 8～130.328 8 μg范围内线性关系良好；柚皮苷的平均回收率为97.13%、RSD值为1.19%，芍药苷的平均回收率为96.61%、RSD值为1.51%。结论 该定性、定量检测方法简便可行、专属性强、重现性好、灵敏度高，可作为补肾通络颗粒的质量控制标准。

Objective To establish the quality standard for Bushen-Tongluo granules. Methods Drynariae rhizoma, Paeoniae radix alba, Cyathulae radix, Chuanxiongin rhizome were identified by thin layer chromatography （TLC）, and the content of naringin and paeoniflorin was determined by high performance liquid chromatography（HPLC） with chromatographic column Agilent C18 （4.6 mm×250 mm, 5 μm）, as the mobile phase was acetonitrile-0.1% phosphoric acid and the scan wave length were 230 and 283 nm. The column temperature was 30 ℃. The flow rate was 1.0 ml/min. Results TLC could identify Drynariae rhizoma , Paeoniae radix alba, Cyathulae radix, Chuanxiongin rhizome effectively. Under the condition, there was a good linear relationship when the content of naringin was in 6.337 0-50.695 7 μg. There is also a good linear relationship when the content of paeoniflorin was in 26.065 8-130.328 8 μg. The average recovery rate of naringin was 97.13% and RSD was 1.19%. The average recovery rate of paeoniflorin was 96.61% and RSD was 1.51%. Conclusions The established methods are simple, specific, reproducible, and sensitive, and they can be used for the quality control of Bushen-Tongluo granules.