Establishment of the Quality Standard for Xiaotang Zhike Pills / 中国药师

ABSTRACT

Objective:To establish the quality standard for Xiaotang Zhike pills.Methods:Atractylodis Rhizoma,Puerariae Lobatae Radix and Scrophulariae Radix in the formula were qualitatively identified by TLC. HPLC was used for the determination of puerarin in Xiaotang Zhike pills. The analysis was performed on a Wondasil C18-WR(250mm × 4.6 mm,5 μm)column with methanol-water(2575) as the mobile phase at a flow rate of 1.0 ml·min-1. The detection wavelength was set at 250 nm, the column temperature was 40℃ and the sample size was 10 μl. Results:TLC showed good specificity without any interference for the identification of atrctylodin,puerarin and harpagoside. The calibration curve of puerarin was in good linearity over the range of 41.20-618.00 ng(r = 0.999 9). The average recovery was 100.16%(RSD = 2.91%). Conclusion:The established methods in the study are simple,feasible and reproducible,which are suitable for the quality control of Xiaotang Zhike pills.