扶正化积合剂质量标准研究

Quality standard of Fuzheng Huaji Mixture

目的建立扶正化积合剂的质量控制方法。方法对扶正化积合剂中黄芪、淫羊藿、三七进行薄层色谱鉴别;采用高效液相色谱法对黄芪甲苷进行含量测定。结果扶正化积合剂中黄芪、淫羊藿、三七的薄层色谱均斑点清晰,阴性对照无干扰;黄芪甲苷进样量在0.2102-4.2040μg范围内线性关系良好（r=0.9997）,平均回收率为96.8%,RSD为0.87%（n=6）。结论本研究建立的薄层色谱法和高效液相色谱法专属性强,准确度高,重复性好,可用于扶正化积合剂的质量控制。

Objective To establish the method for quality control of Fuzheng Huaji Mixture. Methods Astragali Radix,Eplmedii Folium, Notoginseng Radix Et Rhizoma in Fuzheng Huaji Mixture were indentified by TLC. The content of Astragaloside Ⅳ in Fuzheng Huaji Mixture was determined by HPLC. Results The spots of Astragali Radix, Eplmedii Folium, Notoginseng Radix Et Rhizoma in Fuzheng Huaji Mixture on the TLC plate were clear, and the negative control sample had no interference, a good linearity was obtained for Astragaloside Ⅳ in the range of 0.2102-4.2040 μg（r =0.9997）. The average recovery was 96.8%, RSD=0.87%（n=6）. Conclusion The method is specific, accurate and reproducible, it can be used for quality control of Fuzheng Huaji Mixture.