清脑宁颗粒质量标准研究

目的建立清脑宁颗粒的质量控制方法。方法采用薄层色谱（TLC）法对清脑宁颗粒中赤芍、当归、川芎、陈皮进行定性鉴别;采用高效液相色谱（HPLC）法测定清脑宁颗粒中芍药苷含量,色谱柱为岛津C18柱（250mm×4.6mm,5μm）,流动相为甲醇-0.05mol/L磷酸二氢钾（30∶70）,流速为1.0mL/min,检测波长为230nm。结果TLC法能鉴别出赤芍、当归、川芎、陈皮;芍药苷质量浓度在12～120μg/mL范围内与峰面积呈良好的线性关系,r^2=0.9998（n=6）。结论建立的方法简便可行,专属性强,可用于清脑宁颗粒的质量控制。

Study on Quality Standards of Qingnaoning Granules

Objective To establish a method to control the quality of Qingnaoning Ganules.Methods Radix paeoniae rubra,Radix angelicae sinensis,Rhizoma chuanxiong,Pericarpium citri reticulatae were identified by TLC.Paeoniflorin was determined by HPLC.The chromatographic separation was performed on the Shimadzu C18 column（250 mm×4.6 mm,5 μm）by gradient elution with methanol-0.05 mol/L potassium dihydrogen phosphate at the flow rate of 1.0 mL/min,the detection wavelength was set at 230 nm.Results The developed TLC spots were fairly clear and the blank test showed no interference.The linear range was 12-120 μg/mL（r^2=0.999 8）for paeoniflorin.Conclusion The method is effective for the quality control of Qingnaoning Granules.