Quality Standard for Juebi Capsules / 中国药师

ABSTRACT

Objective:To establish the quality standard for Juebi capsules. Methods:TLC was adopted to identify Paeoniae Ra-dix Rubra, Cyperi Rhizom and Cinnamomi Cortex; the contents of paeoniflorin and cinnamic aldehyde in Juebi capsules were deter-mined by HPLC with Wondasil C18 (250 mm × 4. 6 mm,5 μm) as the analytical column, the mobile phase was composed of methanol-0. 2％ phosphoric acid solution with gradient elution, the flow rate was 1. 0 ml·min-1 ,the detection wavelengths were 230 nm and 290 nm, the column temperature was 40℃, and the volume injection was 10 μl. Results: The TLC spots were clear and well-separated without any negative interference;the calibration curves of paeoniflorin and Cinnamic aldehyde were in good linearity over the range of 0. 368-3. 680μg(r=0. 9999) and 0. 191-1. 914 μg(r=0. 9999), the average recovery was 101. 9 ％ and 99. 66％, and the RSD was 1. 90％ and 2. 77％ (n=6), respectively. Conclusion:The method is fast and accurate with good specificity, which can be used for the quality control of Juebi capsules.