黄芪补气养血合剂质量标准研究

Study on Quality Standard of Huangqi Buqiyangxue Mixture

目的建立黄芪补气养血合剂的质量标准。方法采用薄层色谱法对制剂中的主要药味黄芪、白芍和补骨脂进行定性鉴别;采用高效液相色谱法测定当归中主要活性成分阿魏酸的含量,色谱柱为Thermo C18柱(250 mm×4. 6 mm,5μm),流动相为乙腈-0. 085%磷酸溶液(15∶85),检测波长为316 nm,流速为1. 0 m L/min,柱温为35℃。结果 3种药材的薄层鉴别方法专属性强;阿魏酸进样量在0. 015～0. 180μg范围内与峰面积线性关系良好,r=0. 999 9 (n=5),平均回收率为99. 76%,RSD为0. 81%(n=6)。结论该方法操作简单,灵敏度高,重复性好,专属性强,可用于黄芪补气养血合剂的质量控制。

Objective To establish the quality standard of Huangqi Buqiyangxue Mixture. Methods The Astragali Radix, Paeouiae Radix Alba and Psoraleae Fructus in the Mixture were identified by TLC. The content of main active components（ferulic acid） of Augelica siuensis was determined by HPLC with Thermo C18 column（250 mm ×4. 6 mm,5 μm）,the mobile phase was acetonitrile - 0. 085% phosphoric acid solution（15：85）,the detection wavelength was 316 nm,the flow rate was 1.0 mL/min,and the column temperature was 35 ℃. Results The TLC identification method for 3 kinds of Chinese medicinal herbs was highly specific. The sample size of ferulic acid was linear in the range of 0. 015-0. 180 μg, r=0. 999 9（n=5）,the average recovery rate was 99.76%, RSD was 0.81% （n=6）. Conclusion The method is simple, highly sensitive, reproducible and specific, which can be used for the quality control of Huangqi Buqiyangxue Mixture.