芪术扶正饮的质量标准及稳定性初步研究

目的：建立芪术扶正饮的质量标准，初步研究其稳定性。方法运用薄层色谱法对延胡索、甘草进行定性鉴别；采用超高效液相色谱-蒸发光散射检测器测定黄芪甲苷含量；运用加速试验法观察制剂的初步稳定性。结果延胡索、甘草薄层鉴别图谱斑点清晰，阴性均无干扰，专属性强。黄芪甲苷在36.5～365.0μg/ml范围内线性关系良好(r2＝0.9992)，平均回收率为102.8%，RSD为2.4%。经1、2、3、6个月的加速稳定性试验，3个批次制剂中黄芪甲苷的平均含量分别为61.6、60.4、60.6μg/ml。结论该制剂工艺简单，所得制剂质量可控，性质稳定。

A preliminary study on quality standard and stability forQizhu-Fuzheng Yin

Objective To establish the quality standard ofQizhu-Fuzheng Yin, and to conduct a preliminary study on its stability.Methods Corydalis tuber and licorice were identified by TLC. The content of astragaloside was determined by UPLC-ELSD. The initial stability was studied by accelerated test method. Results The spots on TLC plates were clear without interference in the blank reference. The response of astragaloside was linear in the ranges of 36.5-365.0 μg/ml (r2=0.999 2), and the average recovery was 102.8 %, and theRSD was 2.4%. After 1, 2, 3, 6 months tests, the average contents of 3 batches astragaloside were 61.6, 60.4, 60.6μg/ml.ConclusionQizhu-Fuzheng Yin was simple preparation, quality control and stability.