丹黄通络丸质量标准的研究

A study of quality standard for Danhuang Tongluo pills

目的：建立丹黄通络丸的质量标准。方法：采用显微鉴别法对丹黄通络丸方中黄芪、天麻、茯苓等进行显微特征鉴别;采用薄层色谱法对方中丹参、全蝎进行TLC定性鉴别;采用HPLC-ELSD法对方中黄芪甲苷含量进行测定,并进行方法学考察。结果：黄芪甲苷在0.414~4.14mg（r=0.9997）范围呈良好的线性关系,平均回收率为100.19%,精密度、稳定性、重复性RSD均小于3.0%。结论：所建立质量标准方法稳定,重复性好,可有效控制成品质量。

Objective： To investigate the quality standard for Danhuang Tongluo pills. Methods： The microscopic identification method was used to identify the microscopic features of Astragalus membranaceus,Gastrodia elata,and Poria cocos in Danhuang Tongluo prescription. Thin-layer chromatography（ TLC） was used for TLC qualitative identification of Salvia miltiorrhiza and scorpion in this prescription. High-performance liquid chromatography-evaporative light scattering detection was used to measure the content of astragaloside in this prescription,and methodological observation was also performed. Results： Astragaloside showed a good linear relationship within the range of 0. 414-4. 14 mg（ r = 0. 9997）,and the average recovery rate was 100. 19%. Precision,stability,and relative standard deviation were lower than 3. 0%. Conclusion： The established method is stable and has good repeatability;therefore,it can be used for quality control of finished product.