Establishment of Quality Standard for Malloti Apeltae Radix / 中国药师

ABSTRACT

Objective:To perfect and improve the quality standard of Malloti Apeltae Radix. Methods:Microscopic identification was used to identify the transverse section and the powder. The water-soluble and the fat-soluble components were identified by TLC. Rutin was used as the reference in the characteristic chromatogram established by HPLC to determine the relative retention time and rel-ative peak area of each characteristic absorption band. A SPOLAR C18 chromatographic column ( 250 mm × 4. 6 mm,5μm) was used with acetonitrile-0. 4% phosphate solution as the mobile phase with gradient elution, the detection wavelength was set at 328 nm, the flow rate was 1. 0 ml·min-1, and the temperature was 35℃. Results: The microscopic characteristics were obvious. The spots of TLC were round and clear with good repeatability. Five characteristic absorption bands were shown in the fingerprints with the relative retention time within ± 5% of reference value of rutin, and the relative area of peak 3 and peak 4 was not lower than 0. 23 and 0. 66, respectively. Conclusion:The method is convenient, fast and repeatable, and the result is accurate and reliable, which can be used to control the quality of Malloti Apeltae Radix effectively, and as the main index of the quality standard.