Study on Quality Standard of Bushen Quyu Granules / 中国药房

ABSTRACT

OBJECTIVE： To establish the quality standard for Bushen quyu granules. METHODS： TLC was used for qualitative identification of Rosa laevigata， Cuscuta chinensis， processed Fallopia multiflora and Lithospermum erythrorhizon in Bushen quyu granules. And then， the content of total polysaccharides in Bushen quyu granules was determined by UV spectrophotometry. HPLC method was used for the content determination of rutin， quercetin and hyperin in Bushen quyu granules. The determination was performed on BDS C18 column with mobile phase consisted of acetonitrile-0.08％ phosphoric acid solution （gradient elution） at the flow rate of 1 mL/min. The column temperature was 30 ℃， and detection wavelength was set at 370 nm. The sample size was 10 μL. RESULTS： TLC test sample chromatogram of 4 medicinal materials showed the same spot or fluorescence at the corresponding position with the reference substance and control medicinal materials. The linear range of glucose， rutin， quercetin and hyperin were 0.003-0.018 mg/mL， 0.225-7.20 μg/mL， 0.07-2.24 μg/mL and 1.25-39.88 μg/mL（r＝0.999 5 or 0.999 9， n＝6）. RSDs of precision， stability and reproducibility tests were all less than 3％ （n＝6）. Average recoveries were 102.2％， 101.2％， 100.9％， 101.0％ （RSD＝1.28％， 2.93％， 2.41％， 1.59％， n＝6）. Average contents were 0.46 g/g， 5.48        μg/g， 8.18 μg/g and 102.88 μg/g（n＝3）. CONCLUSIONS： Established quality standard of Bushen quyu granules is accurate and reliable， and can provide scientific reference for quality control of Bushen quyu granules.