瑶药风湿骨痛喷雾剂Ⅰ的质量控制方法

Study of Quality Control Methods for Rheumatism Ostalgia Spray Ⅰ

目的:建立瑶药风湿骨痛喷雾剂Ⅰ的质量控制方法。方法:对处方中主要瑶药钩吻和两面针进行薄层图谱鉴定;采用高效液相色谱法,乙腈-甲醇-水(4:56:240),磷酸0.3%,三乙胺0.5%,检测波长230 nm,柱温25℃,流速1.0 mL.min-1,测定处方中主要镇痛成分钩吻素子的含量。结果:在薄层色谱图谱中均能检出瑶药钩吻和两面针;钩吻素子在0.199 2～3.187 2μg呈良好的线性关系(r=0.999 7),平均回收率为98.41%,RSD 1.408 6%(n=6)。结论:所建立的方法稳定可靠,可以有效控制该制剂的质量。

Objective： To establish the quality standard of Rheumatism ostalgia Spray Ⅰ Method： TLC was used in qualitative identification of Gelsemium elegans and Zanthoxylum nitidum. And HPLC was used for assay of koumine in the preparation. Result： G. elegans and Z nitidum ＇were detected by TLC. Koumine had a good linear relationship within the range of 0. 199 2-3. 187 2 μg （r = 0. 999 7）. The average recovery was 98.41% , and the RSD was 1. 409%. Conclusion： The method established is stable and reliable. It can be used for quality control of the preparation.