风湿关节炎片质量标准研究

Study on quality standard for Fengshi Guanjieyan tablets

目的:制定风湿关节炎片的质量标准。方法:采用薄层色谱法鉴别麻黄、当归,薄层板为硅胶 G 薄层板;采用高效液相色谱法测定士的宁的含量,色谱柱为 Betasil C_(18)(4.6 mm×200 mm,5μm),流动相为乙腈-水-三乙胺(20:80:0.5,用醋酸调pH 为2.5).流速为1.0 mL·min^(-1),检测波长为254 nm。结果:在薄层色谱中均能检出麻黄、当归;高效液相色谱法测得士的宁在0.095～0.760μg范围内呈良好的线性关系(r=0.9996);平均回收率(n=6)为98.6%。结论:该方法准确、灵敏,重复性好,能有效地控制风湿关节炎片的质量。

Objective：To establish the quality standard for Fengshi Guanjieyan tablets. Methods：Herba Ephedrae and Radix Angelicae Sinensis were identified by TLC. The thin layer plate was silica gel G. The content of strychnine was determined by HPLC. The column of Betasil C18 （4. 6 mm × 200 mm,5 μm）was used, the mobile phase was acetonitrile -water -triethylamine（20： 80： 0.5, adjusted pH to 2. 5 with acetic acid） , the detection wavelength was set at 254 nm and the flow rate was 1.0 mL · min^-1. Results：Herba Ephedrae and Radix Angelicae Sinensis could be identified by TLC. Strychnine showed a good linear relationship at a range of 0. 095 - 0. 760 μg, r= 0. 9996. The average recovery（ n = 6）was 98.6%. Conclusion：The method is simple with good reproducibility and can be used as the quality control Fengshi Guanjieyan tablets.