芪麦苓口服液质量标准研究

Study on Quality Standard for Qimailing Oral Liquid

目的制定芪麦苓口服液质量标准。方法采用薄层色谱法（TLC）对处方中的黄芪、丹参、牡丹皮、地黄、茯苓5种药材进行定性鉴别；采用高效液相色谱法（HPLC）测定处方中丹参的原儿茶醛含量。色谱柱为DiamonsilC18柱（250mm×4．6mm，5μm），流动相为甲醇-0．1％冰乙酸（20：80），检测波长279nm，流速1．0mL／min，柱温30℃。结果各药材的薄层色谱斑点清晰；原儿茶醛在1．46-116．64μg／mL范围内呈良好的线性关系，r=0．9999；平均加样回收率为95．1％，RSD=1．4％，n=6。结论各方法简便、准确，可用于芪麦苓口服液的质量控制。

Abstract： Objective To establish the quality standard for Qimailing Oral Liquid. Methods Astragali radix, Salviae Miltiorrhizae radix et rhizoma, Moutan cortex, Rehmanniae radix and Poria in oral liquid were identified by TLC. The content of protocatechuic aldehyde in Salviae Miltiorrhizae radix et rhizoma was determined by HPLC. Diamonsil C18 （250 mm×4.6 mm, 5 μm） was applied, using methanol-0.1% acetic acid （20：80） as mobile phase, with the flow rate of 1.0 mL/min. The detection wavelength was set at 279 nm, and the column temperature was kept at 30 ℃. Results The TLC spots of all samples can be well separated. The liner range for protocatechuic aldehyde was 1.46-116.64 μg/mL. The average recovery was 95.1%, with RSD of 1.4 %. Conclusion The methods are simple, sensitive and accurate, and can be used for quality control of Qimailing Oral Liquid.