鼻敏通胶囊质量标准研究

Studies on the Quality standard of Bimintong Capsule

摘要:

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-Pack ODS 柱(4.6 mm×150 mm,5 μm);流动相为乙腈-水(60 ∶40),检测波长322 nm,流速1.0 mL ·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5.68~56.80 μg ·mL-1范围内线性关系良好(r=0.999 8)。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。

Abstract:

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.