菊藤胶囊制备工艺及质量标准研究

Study on the preparation technology and quality standards of Juteng Capsules

目的优化菊藤胶囊的制备工艺,提升菊藤胶囊的质量标准。方法采用正交实验法优化制备工艺;采用薄层色谱法(TLC)对处方中的君药菊花,臣药中的栀子、丹参、地龙、防己以及使药甘草进行研究,采用高效液相色谱法(HPLC)对臣药栀子中的主要成分栀子苷进行了含量测定。结果优化后的制备工艺简单可行,TLC斑点清晰,阴性对照无干扰。栀子苷在8.91~89.10μg·mL-1的范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为99.25%,RSD值为1.18%(n=6)。结论该工艺科学、合理,质量标准方法易于操作、专属性强、重复性好,所建立的质量标准可用于该制剂的质量控制。

Objective To optimize the preparation technology of Juteng Capsules and to promote the quality standards of Juteng Capsules.Methods The preparation technology was optimized by orthogonal test;TLC was used to identify the chrysanthemum,gardenia,salvia miltiorrhiza,earthworm,radix stephaniae tetrandrae and licorice,and HPLC was used to quantitatively measure the content of geniposide.Results The optimized preparation technology was simple and feasible.The TLC spots were clear,and no interference was observed.The calibration curve of geniposide was in good linear over the range of 8.91-89.10μg·mL^-1（r=0.999 9）and the average recovery was 99.25%,RSD was 1.18%（n=6）.Conclusion The optimized preparation technology was reasonable,and the quality standard methods were easy to be operated with strong specificity and good repeatability.The established quality standards can be used for controlling the quality of Juteng Capsules.