柴芍解郁颗粒质量标准研究OA

Objective To establish a quality standard for Chaishao Jieyu granules.Methods Thin-layer chromatography(TLC)was used for the qualitative identification of Bupleuri Radix Praeparata cum Aceto,Paeoniae Radix Alba,Moutan Cortex,Gardeniae Fructus Praeparatus,Salviae Miltiorrhizae Radix et Rhizoma,and Glycyrrhizae Radix et Rhizoma in the granules.Characteristic spots were observed at the positions corresponding to those of reference substances or reference herbs under daylight or ultraviolet light(254 nm or 365 nm).High-performance liquid chromatography(HPLC)was applied for the quantitative determination of paeoniflorin.The separa-tion was performed on an Eclipse XDB-C18 column(250 mm×4.6 mm,5 μm)with acetonitrile-0.1%phosphoric acid solution(volume ratio 12∶88)as the mobile phase.The column temperature was set at 25℃,the flow rate was 1.0 mL/min,and the detection wave-length was 230 nm.Results In TLC,clear and specific spots of all medicinal materials were observed at positions corresponding to the control samples,and no interference was found in negative controls.Paeoniflorin showed a good linear relationship in the range of 0.131 2-1.180 8 μg,with the regression equation of y=1×106x-18 220(R²=0.999 5).The limits of detection and quantitation were 0.024 μg and 0.087 μg,respectively.The RSD values for stability and repeatability were both below 1.5%(n=6).The mean recovery rate was 95.95%(RSD=1.64%),and the average transfer rate of paeoniflorin in three batches was 56.60%.Therefore,the content of paeoniflorin in each sachet showed no less than 18.34 mg(C₂₃H₂₈O₁₁),calculated based on Paeoniae Radix Alba and Moutan Cortex.Conclusion The established TLC methods and HPLC method are simple,accurate and specific,and can be effectively applied for the quality control of Chaishao Jieyu granules.