Improvement in Quality Standard for Neixiao Granules

Objective To establish a standard for quality control of Neixiao granules. Methods The 6 chief herbs of the preparation,Coptidis rhizoma,Paeoniae radix alba,Gardeniae fructus,Sophorae fructus,Rhei radix et rhizome and Aurantii fructus immaturus were identified by TLC qualitatively. The content of paeoniflorin in Paeoniae radix alba was determined by HPLC. The separation was performed on Thermo Hypersil ODS-2( 4. 6 mm × 250 mm,5 μm) with a mobile phase that consisted of acetonitrile-0. 1% phosphoric acid solution( 16∶ 84) at a flow rate of 1. 0 ml·min- 1. The detection wavelength was 230 nm and the column temperature was 30 ℃. Results In TLC,spots of the same color were observed in corresponding positions of control materials or controls without interference.In HPLC,the linear range for paeoniflorin was 0. 1524- 1. 524 μg( r = 1. 0000,n = 6),the average recovery was99. 21% and its RSD was 2. 99%( n = 9). Conclusion This method is operatable,accurate,and highly reproducible,which can be used for quality control of Neixiao granules.