Study on the Quality Standard for Xiao'er Hanting Granule / 中国药师

ABSTRACT

Objective:To establish the quality standard for Xiao'er Hanting granule. Methods:Astragali Radix,Rhizoma Atrac-tylodis Macrocephalae (baked) and Saposhnikoviae Radix were qualitatively identified by a TLC method. The contents of calycosin-7-O-β-D-glycoside in the preparation were determined by an HPLC method. The chromatographic column was Cosmosil C18(250 mm× 4.6 mm,5 μm);the mobile phase was acetonitrile-0.2% methanoicacid(1684); the flow rate was 1.0 ml·min-1; the detection wavelength was 260 nm. Results:Astragaloside A in Astragali Radix was detected by the TLC method,and Rhizoma Atractylodis Mac-rocephalae (baked),Saposhnikoviae Radix and saposhnkoviae standard crude drug had the same clear spots without any negative inter-ference. The linear range of calycosin- 7-O-β-D-glycoside was 0.061-0.613 μg(r =0.999 9). The average recovery was 99.4% (RSD=1.29%,n=6). Conclusion:The method is accurate,rapid,stable and reliable with good reproducibility,which is suitable for the quality control of Xiao'er Hanting granule.