痛风利湿口服液质量标准研究

目的 建立痛风利湿口服液的定性、定量质量控制方法.方法 采用薄层色谱法对方中大黄、山楂、王不留行进行定性鉴别;采用高效液相色谱法对大黄素进行定量测定,色谱柱采用Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸(85:15),流速为1.0mL/min,柱温为室温,检测波长为254 nm.结果 在薄层色谱中均能够检测出大黄、山楂、王不留行药材;大黄素检测质量浓度在12.0～60.0 μg/mL范围内与峰面积线性关系良好(r=0.999 6),平均加样回收率为95.3%,RSD=1.03%(n=9),方法重复性RSD为3%.结论 所用方法专属性强,灵敏度高,重现性好,可用于控制痛风利湿口服液的质量.

Study on Quality Standard of Tongfenglishi Oral Solution

Objective To establish the qualitative and quantitative quality control method of Tongfenglishi Oral Solution.Methods Rhubarb,hawthorn and cowherb seed in Tongfenglishi Oral Solution were qualitatively identified by thin-layer chromatography（TLC） and emodin was identified by the high performance liquid chromatography（HPLC）.The Diamonsil C18 column（250 mm×4.6 mm,5 μm） was used with methanol-0.1%H3PO4（85：15） as the mobile phase,the flow rate was of 1.0 mL/min,and the detection wavelength was at 254 nm.Results Rhubarb,hawthorn and cowherb seed could be detected by TLC.The linear rang of emodin was 12.0-60.0 μg/mL,and the average recovery rate was of 95.3%（RSD=1.03%,n=9）,the repeatability RSD was 3%.Conclusion The established method is sensitive,rapid,strongly specific and better reproducible,and could be used for the quality control of Tongfenglishi Oral Solution.