Quality Standard for Psoraleae Fructus Tinctures / 中国药师

ABSTRACT

Objective:To establish a quality control standard for psoraleae fructus tinctures. Methods:The identification was de-tected by TLC on silica gel G plates with hexane-ethyl acetate (8∶2) as the developing solvent. An HPLC method was applied in the quantitative determination of psoralen and isopsoralen as the effective components. The analytical column was Intersil ODS-3 (250 mm × 4. 6 mm,5 μm) with methanol-water(45∶55) as the mobile phase;the flow rate was 1 ml·min-1;the detection wavelength was at 246 nm and the column temperature was set at 35℃. Results:The characteristic spots for psoralen and isopsoralen were identified by TLC. The concentration of psoralen showed good linearity within the range of 4. 88-187. 50μg·ml-1(r=0. 999 9)and the average re-covery was 102. 63% and RSD was 0. 43%. The concentration of isopsoralen showed good linearity within the range of 4. 25-163. 20μg ·ml-1(r=0. 999 9), and the average recovery was 102. 37% and RSD was 1. 13%. Conclusion: The qualitative and quantitative methods are simple, accurate, feasible and repeatable, which can be used in the quality control of psoraleae fructus tinctures.