Study on the quality standards for Zhixuan Granule / 中成药

ABSTRACT

Objective: The quality standards for Zhixuan Granule (Rhizoma Alismatis, Rhizoma Atractylodis Macrocephalae, etc.) were studied. Methods: The TLC methods for identification of Rhizoma Alismatis、 Rhizoma Atractylodis Macrocephalae were established. A simple HPLC was established for the determination of 23-acetate alisol B. The mobile phase was acetonitrile-water(70∶30). UV detecting wavelength was at 208nm. Results: Rhizoma Alismatis and Rhizoma Atractylodis Macrocephala could be detected. 23-acetate alisol B showed a linear relationship at the concentration range of 99～1388.8ng, r=0.9999. The average recovery was 103.05% and RSD was 2.41%(n=6). Conclusion: This method is suitable for the quality control of Zhixuan Granule.