安乳颗粒质量标准研究

目的建立安乳颗粒的质量控制方法。方法采用薄层色谱法对方中赤芍、当归、丹参、香附、乳香、没药进行定性鉴别,采用高效液相色谱法分别对芍药苷及阿魏酸进行含量测定。芍药苷采用Agilent C18柱（4.6 mm×250 mm,5μm）色谱柱,流动相为乙腈-水（13∶87）,检测波长230 nm,流速1.0 mL/min,柱温30℃。阿魏酸采用Diamonsil C18（4.6 mm×150 mm,5μm）色谱柱,流动相为50%甲醇-乙腈-0.1%冰醋酸（25∶5∶70）,检测波长320 nm,流速1.0 mL/min,柱温35℃。结果在薄层色谱中能检测出上述6种主要药材;芍药苷在0.12～1.20μg范围内有良好的线性关系（r=0.999 8）,平均回收率为98.07%,RSD=1.03%。阿魏酸在0.021 6～0.129 6μg范围内有良好的线性关系（r=0.999 6）,平均回收率为99.52%,RSD=0.99%。结论本方法简便、准确,可用于安乳颗粒的质量控制。

Study on Quality Standard for Anru Granules

Objective To establish the method for quality control of Anru Granules.Methods Radix Angelicae Sinensis,Radix Paeoniae Rrubra,Salvia miltiorrhiza Bge,Rhizoma cyperi,Olibanum and Myrrha were identified by TLC.The content of paeoniflorin and ferulic acid was determined by HPLC.The Agilent C18（4.6 mm×250 mm,5 ？m） was adopted,the mobile phase of paeoniflorin was acetonitrile-water（13∶87） at the flow rate of 1.0 mL/min,the temperature was 30 ℃,and the detecting wavelength was 230 nm.The Diamonsil C18（4.6 mm×150 mm,5 ？m） was used,the mobile phase of ferulic acid was 50% methanol-acetonitrile-0.1% glacial acetic acid（25∶5∶70） at the flow rate of 1.0 mL/min,the temperature was 35 ℃,the detecting wavelength was 320 nm.Results The above mentioned 6 main Chinese crude drugs were detected by TLC.Paeoniflorin showed a good linear relationship at the range of 0.12-1.20 ？g,r=0.999 8.The recovery was 98.07%,RSD=1.03%.Ferulic acid showed a good linear relationship at the range of 0.021 6-0.129 6 ？g.The recovery was 99.52%,RSD=0.99%.Conclusion The method is accurate and reliable.It can be applied to the quality control of Anru Granules.