关键词: font-size:medium, ">地黄配方颗粒；高效液相色谱法；指纹图谱；质量研究

Abstract: Objecetive： To establish an HPLC fingerprint of Rehmannia glutinosa Libosch. dispensing granules and provide experimental evidence for its quality criteria. Methods： Take water extract of Rehmannia glutinosa Libosch. dispensing granules by ultrasonic processing and then eluted by D101 type macroporous adsorption resin column. The evaporation of eluent was dissolved by acetonitrile-0.1% phosphoric acid. HPLC analysis was carried out on Welch Ultimate LP -C18（4.6 mm×250 mm， 5 μm）chromatographic column with mobile phase of acetonitrile(A)-0.1% phosphoric acid(B)， gradient elution with a flow at 1.0 mL·min-1， an ultraviolet detection wavelength at 330 nm. The column temperature was 30 ℃， the injection volume was 20 μL and the record time was 90 min. Results： The RSD of the precision， stability and repeatability test of Rehmannia glutinosa Libosch. dispensing granules 0.03%， 0.06%， and 0.21% respectively， all of which were not more than 2.0% (n=6). The separation effect of each chromatographic peak of the chromatogram obtained by gradient elution was good， which meets the requirements of fingerprint. A systematic comparison with the fingerprints of Rehmannia glutinosa medicinal materials， decoction pieces and decoctions showed that the similarity of each batch of samples was high， and the uniformity was good. They all showed 8 common peaks. The relative retention time of each common peak was stable and exclusive. Conclution： The method is accurate， reliable， and reproducible. It can provide a reference for the quality evaluation of Rehmannia glutinosa Libosch. dispensing granules.
   

Key words: font-size:medium, ">Rehmannia glutinosa Libosch. dispensing granules； HPLC； Fingerprint； Quality research