Study on Quality Standard for Peony Pollen Buccal Tablets / 中国药房

ABSTRACT

OBJECTIVE： To establish a method for quality control of Peony pollen buccal tablets， and to provide reference for the formulation of quality standard. METHODS： TLC method was used for qualitative identification of paeoniflorin， kaempferol and luteolin in Peony pollen buccal tablets according to 2015 edition of Chinese Pharmacopeia （part Ⅳ）. The contents of paeoniflorin and oxypaeoniflorin in Peony pollen buccal tablets were determined by dual-wavelength HPLC method [The determination was perform on Agilent TC-C18 column with mobile phase consisted of acetonitrile （A）-0.1％ phosphoric acid solution （B） with gradient elution at the flow rate of 1.0 mL/min. The detection wavelength was set at 230 nm for paeoniflorin and 258 nm for oxypaeoniflorin. Sample size was 20 μL]. RESULTS： TLC identification of paeoniflorin， kaempferol and luteolin showed that the same color characteristic spots of control chromatogram appeared in the corresponding positions of sample chromatogram without interference from negative samples. The linear range of paeoniflorin and oxypaeoniflorin were 7.2-86.4        μg/mL and 2.72-32.64 μg/mL（r≥0.999 7），respectively. The average recoveries were 99.12％ and 98.65％， and RSD were 1.54％ and 2.53％（n＝6），respectively. RSDs of precision （n＝6）， stability （n＝8） and reproducibility （n＝6） tests were all lower than 3.0％. CONCLUSIONS： The method is simple and reproducible， and can be used for quality control of Peony pollen buccal tablets.