黄马通淋口服液质量标准研究

Study on the Quality Standard of Huangma Tonglin Oral Liquid

关键词:  黄马通淋口服液  质量标准  TLC  HPLC

Key words:  Huangma Tonglin Oral liquid  quality standard  TLC  HPLC

摘要:

选取了不同产地的药材制备出10批黄马通淋口服液的样品,进行性状、pH值,相对密度的检查,采用盐酸镁粉颜色反应定性鉴别黄马通淋口服液中的黄酮类化合物,采用TLC法对黄马通淋口服液中一枝黄花进行定性鉴别,并采用HPLC法测定毛蕊花糖苷含量。选用Agilent Zobax Eclipse Plus C18色谱柱(4.6 mm×250 mm,5 μm)；以乙腈-0.2%磷酸(20:80)为流动相,检测波长为330 nm,柱温为30℃,流速为每分钟1.0 mL,进样量为10 μL。10批黄马通淋口服液均为棕色至棕褐色液体,pH值在4.7～5.2,相对密度在1.05~1.11；在盐酸镁粉颜色反应中,溶液显示出橙黄色,说明制剂中含有黄酮类化合物；在薄层鉴别中一枝黄花有良好的鉴别特征；有效成分毛蕊花糖苷浓度在10.36~207.20 μg/mL时,进样浓度与峰面积之间存在良好的线性关系(r=0.9992)；平均加样回收率为101.96%,RSD=1.99%。盐酸镁粉反应中颜色反应明显,易辨别。在薄层鉴别中一枝黄花有良好的鉴别特征,方法操作简便、阴性对照无干扰；毛蕊花糖苷的含量测定方法简便、准确、可靠,可用于控制黄马通淋口服液的质量。

Abstract:

Ten batches of samples of Huangma Tongling oral liquid were prepared from different sources, and their properties, pH value and relative density were checked. The flavonoid compounds was used to identified by HCl-Mg color reaction. The Herba Solidaginis was identified by TLC, and the content of verbascoside was detected by HPLC. Agilent Zobax Eclipse Plus C18 column(4.6 mm×250 mm,5 μm) was selected in chromatographic separation. The mobile phase of acetonitrile-0.2% phosphoric acid (20:80).The detective wavelength was set at 330 nm.The column temperature was kept at 30℃.The flow rate was 1.0 mL.min^-1 and the injection volume was 10 μL. All the 10 batches of Huangma Tonglin oral liquid were brown to tan liquid with pH value ranging from 4.7 ~ 5.2 and relative density ranging from 1.05~1.11.The result of HCl-Mg color reaction indicated that there was flavonoid compounds in Huangma Tonglin Oral liquid. The Herba Solidaginis could be identified by TLC and the calibration curve of Verbascoside presented a good linearity between 10.36μg.mL^-1 to 207.20 μg.mL^-1 with 0.9992 as correlation coefficient. The average recovery of determination of Verbascoside was 101.96% with RSD 1.99%. The color reaction of magnesium hydrochloride powder is obvious and easy to distinguish.This method to identify Solidago decurrens Lour in Huangma Tonglin Oral liquid by TLC is simple and has a great repeatability.The negative control sample has no interference.The method to determine the content of verbascoside in Huangma Tonglin Oral liquid is rapid, accurate and reliable.The methods can be usedto control the quality of Huangma Tonglin Oral liquid.