玄麦甘桔口服液质量标准的提高

Improvement of the Quality Standard for Xuanmai Ganju Oral Liquid

目的:建立玄麦甘桔口服液的质量提高标准。方法:采用TLC色谱法对菊花、甘草进行定性鉴别;采用HPLC色谱法定量测定菊花中木犀草苷的含量,以Ecos IL C18柱为色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%乙酸溶液梯度洗脱,检测波长为350 nm,流速为1.0 ml·min^-1,进样量为10μl,柱温为30℃。结果:TLC鉴别斑点清晰,阴性样品无干扰;木犀草苷进样量在58.65~586.50 ng之间,线性良好(r=1.000 0),平均回收率为104.1%,RSD为1.4%(n=6)。结论:本方法结果可靠,操作简便,可用于玄麦甘桔口服液的质量控制。

Objective: To improve the quality standard for Xuanmai Ganju oral liquid. Methods: Two herbs in the preparation,Chrysanthemum and Licorice,were identified by TLC qualitatively. The content of luteolin-7-O-glucoside in Chrysanthemum was determined by HPLC. The chromatographic separation was carried out on an Ecos IL C18 column( 250 mm × 4. 6 mm,5 μm) at 30℃. The mobile phase consisted of acetonitrile-0. 1% acetic acid solution with gradient elution at a flow rate of 1. 0 ml·min-1,and the injection volume was 10μl. The detection wavelength was 350 nm. Results: The spots in TLC were clear without any interference. The linear range of luteolin-7-O-glucoside was 58. 65-586. 50 ng( r = 1. 000 0). The average recovery was 104. 1% and the RSD was 1. 4%( n = 6). Conclusion: The method is reliable and easy to operate,which can be used for the quality control of Xuanmaiganju oral liquid.