脑康灵A胶囊质量标准研究

Study on Quality Standard of Naokangling A Capsules

目的：建立脑康灵A胶囊的质量控制方法。方法：采用薄层色谱法（TLC）对脑康灵A胶囊中的川芎、丹参、车前子进行定性分析,采用高效液相色谱法（HPLC）测定制剂中川芎的阿魏酸含量。以十八烷基硅烷键合硅胶为填充剂;色谱柱：C18柱（250 mm×4.6 mm,5μm）;流动相：乙腈-0.085%磷酸溶液（13∶87）;检测波长：321 nm;流速：1.0 m L/min,进样量10μL。结果：川芎、丹参、车前子的薄层色谱鉴别供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的斑点,分离较好,阴性对照无干扰。阿魏酸质量浓度在100.8～604.8 ng范围内与其峰面积积分值成良好线性关系（r=0.9999）;精密度、稳定性、重复性实验的RSD〈3%;平均加样回收率为101.04%,RSD=2.93%（n=6）。结论：该方法操作简单、灵敏度高、专属性强、重复性好,可作为脑康灵A胶囊的质量控制方法。

Objective：To establish a quality control method of Naokangling A Capsules. Methods：Rhizome of Rhizoma Chuanxiong,Salvia miltiorrhiza,Plantago asiatica L. of the Naokangling A Capsules were qualitatively identified by TLC. The content of Ferulic acid was determined by HPLC. The determination was performed on Phenomenex Luna C18（250 mm×4.6 mm,5 μm）;mobile phase consisted of acetonitrile-0.085% phosphoric acid solution（13∶87,V/V）;detection wavelength was 321 nm;at the flow rate of 1.0 m L/min and the sample size was 10 μL. Results：TLC spots were clear and wellseparated without interference from negative control. The linear range of ferulic acid was 100.8~604.8 ng（r=0.9999）with an average recovery of 101.04%,RSD=2.93%,（n=6）. The RSD of precision,stability and reproducibility test were lower than 3%. Conclusion：The method is simple,sensitive,specific and reproducible,and can be used for the quality control for Naokangling A Capsules.