鼻敏通胶囊质量标准研究

Studies on the Quality standard of Bimintong Capsule

目的:建立鼻敏通胶囊的质量标准。方法:采用TLC法鉴别方中的川芎、独活和防风。用HPLC法测定蛇床子素的含量,采用Shim-PackODS柱(4.6mm×150mm,5μm);流动相为乙腈-水(60∶40),检测波长322nm,流速1.0mL·min-1。结果:TLC色谱法检出川芎、独活和防风,阴性对照无干扰。蛇床子素浓度在5.68～56.80μg·mL-1范围内线性关系良好(r=0.9998)。平均回收率为99.27%,RSD=1.01%(n=6)。结论:建立的TLC和HPLC方法专属性强、灵敏度高、重复性好,可用于鼻敏通胶囊的质量控制。

Objective： To establish the quality standard of Bimintong Capsule. Method： Rhizoma chuanxiong,Radix Angelicae pubescentis,and Radix saposhnikoviae were identified by TLC. The HPLC method was established to determine the content of osthole. A Shim-Pack ODS column was used with acetonitrile-water（60 ∶ 40） as mobile phases. The flow rate was 1. 0 mL·min -1. The detection wavelength was at 322 nm. Result： Rhizoma chuanxiong,Radix Angelicae pubescentis,and Radix saposhnikoviae could be identified by TLC and there were noninterference of the negative controls. Osthole was linear in the range of 5. 68 ～ 56. 80 μg·mL -1 （ r = 0. 999 8）. The average recovery was 99. 27% ,and RSD 1. 01% （n = 6）. Conclusion：The method established can be used as quality control for Bushen Jianpi Granule.