Study on Quality Standard Improvement of Qiju Dihuang Oral Liquid / 中国药房

ABSTRACT

OBJECTIVE： To provide reference for perfecting and improving the quality standard of Qiju dihuang oral liquid. METHODS： According to No. 0502 method stated in 2015 edition of Chinese Pharmacopeia （part Ⅳ）， TLC method was used to identify the fruit of Chinese wolfberry， Dendranthema morifolium and Paeonia suffruticosa in Qiju dihuang oral liquid. Using the fruit of C. wolfberry， D. morifolium and paeonol as control， the deployment systems were trichloromethane-ethyl acetate-formic acid （6 ∶ 1 ∶ 0.5， V/V/V）， trichloromethane-isopropanol-formic acid （10 ∶ 1 ∶ 0.5， V/V/V） and cyclohexane-ethyl acetate （3 ∶ 1， V/V）. The contents of morroniside， loganin and paeonol in Qiju dihuang oral liquid were determined by HPLC. The determination was performed on InertSustain C18 column with mobile phase consisted of acetonitrile-0.03％ phosphoric acid solution（gradient elution）at the flow rate of 1.0 mL/min. The detection wavelength was set at 240 nm （morroniside and loganin） and 274 nm （paeonol）， and the column temperature was 40 ℃. The sample size was 10 μL. RESULES： In TLC of the fruit of C. wolfberry， D. morifolium and P. suffruticosa， same color spots were shown in the corresponding positions of reference substance/control chromatogram without interference from negative control. The linear ranges of morroniside， loganin and paeonol were 2.12-106.17， 1.91-95.63 and 4.78-239.16 μg/mL （R2＝0.999 9， 0.999 9， 0.999 8）， respectively. The limits of quantitation were 2.12， 1.91， 2.39 μg/mL； the limits of detection were 0.53， 0.48， 0.59 μg/mL， respectively； RSDs of precision， reproducibility and stability tests were lower than 2％ （n＝6）. The average recoveries were 98.27％， 97.06％ and 97.65％ RSD were 0.80％， 1.18％ and 1.36％ （n＝6）. RSDs of durability tests were all lower than 2％ （n＝3）. CONCLUSIONS： The established method is simple， specific and durable， and can provide reference for improving the quality standard of Qiju dihuang oral liquid.