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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 establish the quality standard of Dan Huang Tong Luo Pills. Methods: Microscopic identification was used to identify the characteristics of Astragalus membranaceus, Gastrodia elata Blume, Poria cocos from Danhuangtongluo pill, TLC identification of Radix Salviae Miltiorrhizae and Scorpio was carried out by TLC, and HPLC-ELSD Astragaloside content was measured, and methodological study. Results: Astragaloside had a good linear relationship in the range of 0.414-4.14 mg (r = 0.9997) with an average recovery of 100.19%. The RSDs of precision, stability and repeatability were less than 3.0%. Conclusion: The established quality standard method is stable and reproducible, which can effectively control the quality of finished products.