Study on Quality Standard for Dibu Gengnian'an Granules / 中国药师

ABSTRACT

Objective: To establish the quality standard for Dibu Gengnian 'an granules. Methods: Fructus Schisandrae, Radix Pueaariae, Radix Angelicae Sinensis, Fructus Psoraleae and Radix Glycytthizae in the formula were identified by TLC. The content of puerarin in the formula was determined by HPLC. The determination was performed on a Welchrom C18 (200 mm × 4. 6 mm, 5 μm) column with the mobile phase consisting of methanol-0. 5% glacial acetic acid (25∶75) at the flow rate of 1. 0 ml·min-1 . The detec-tion wavelength was set at 250 nm, and the column temperature was 25℃. Results:The spots in TLC were clear with good separation and specificity. The linearity of the calibration curve was good within the range of 5-120 μg·ml-1 for puerarin (r=0. 999 8). The RSDs of precision, stability and reproducibility tests were all lower than 3%. The average recovery was 99. 09% (RSD=2. 38%, n=6). Conclusion:The method is simple, specific, accurate and reliable. It can be used in the quality control of Dibu Gengnian’an granules.