通窍鼻渊丸质量标准研究

Study on Quality Control of Tongqiao Biyuan Wan

目的建立通窍鼻渊丸(浓缩丸)的质量控制方法。方法采用薄层色谱法对方中栀子、麻黄、川芎药材进行定性鉴别。采用高效液相色谱法对方中栀子的有效成分栀子苷进行含量测定。结果定性鉴别色谱特征明显。方法学考察表明,栀子苷进样量在0.162 4～1.624μg范围内线性关系良好,r=0.999 4,平均加样回收率为98.26%(RSD=2.83%,n=5)。结论本方法简便、可靠、专属性强、重复性好,可用于通窍鼻渊丸的质量控制。

Objective To establish a method for the quality control of Tongqiao Biyuan Wan（condensed pill）.Methods Cape jasmine,ephedra and Ligusticum wallichii were identified by thin-layer chromatography（TLC）.The gardenoside content of Cape jasmine was determind by HPLC.Results The characteristic for identification by TLC was distinct.The methodological tests showed a good linear relationship in the range of 0.162 4-1.624 μg（r=0.999 4）,and the average recovery was 98.26%（RSD=2.83%,n=5）.Conclusion The method is convenient and reliable,with good specifity and reproducibility.It can be used for the quality control of Tongqiao Biyuan Wan.